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Tolerance clinical trials

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NCT ID: NCT04651829 Completed - Atopic Dermatitis Clinical Trials

Suspicion of Non IgE-mediated Cow's Milk Protein Allergy: Prevalence and Evolution

Start date: May 2014
Phase:
Study type: Observational

Cow's milk protein allergy (CMPA) is often evoked in infants, in particular in front of delayed symptoms such as rectal bleeding, atopic dermatitis, excessive crying, reflux, failure to thrive... But in case of non IgE-mediated CMPA, the only way to diagnose this allergy is to proceed to an elimination-reintroduction test over a period of 2 to 4 weeks, to improve symptoms first, and then provoke them. Even if the diagnosis is confirmed, we speculate that non IgE-mediated CMPA has a faster resolution than other CMPA. The first aim of this study is to estimate the prevalence of non IgE-mediated CMPA in a cohort of infants with delayed symptoms which could be relied to a CMPA. The second goal is evaluate the age of tolerance in non IgE-mediated CMPA with oral food challenge for milk ever 2 months after 4 months of age.

NCT ID: NCT04596644 Suspended - Pain Clinical Trials

Impact of Repeatedly-Administered THC-cannabis on Experimental Pain and Abuse Liability in Humans

Start date: August 1, 2021
Phase: Phase 2
Study type: Interventional

Chronic pain is a significant public health concern in the U.S., for which prescription opioids have historically been the standard treatment. This has resulted in striking rates of opioid use disorders and fatal overdoses. Identifying non-opioid medications for the management of chronic pain with minimal abuse liability is a public health necessity, and cannabinoids are a promising drug class for this purpose. More than 80% of medicinal cannabis users report pain as their primary medical indication, and they report experiencing minimal psychoactive effects. However, there are few well-controlled human laboratory studies assessing cannabis' efficacy for pain in the context of abuse, and even less is known regarding the effects of daily repeated use of cannabis on pain and its relationship to abuse liability. Carefully controlled research is needed. The proposed randomized, within-subjects, placebo-controlled 16-day crossover inpatient human laboratory study (N = 20 healthy cannabis users; 10 men, 10 women) will address three important gaps in our understanding of the potential therapeutic utility of cannabis for pain: 1) Does tolerance develop to repeated, daily smoked cannabis administration on measures of experimental pain and abuse liability; 2) If so, is tolerance reversed during the 7 days of abstinence from active-THC cannabis; 3) Does abrupt abstinence from active cannabis increase experimental pain sensitivity, i.e. hyperalgesia, relative to baseline, and do these effects parallel measures of cannabis withdrawal such as disrupted mood and sleep? Two distinct modalities of experimental pain will be assessed: The Cold Pressor Test (CPT) and Quantitative Sensory Testing Thermal Temporal Summation (QST-TTS). Throughout the study, experimental pain and abuse-related effects will be assessed, as will sleep and subjective mood assessments.

NCT ID: NCT04576507 Suspended - Pain Clinical Trials

Repeated Cannabis Administration on Experimental Pain and Abuse Liability

Start date: June 1, 2021
Phase: Phase 1
Study type: Interventional

Chronic pain is a significant public health concern in the U.S., for which prescription opioids have historically been the standard treatment. This has resulted in striking rates of opioid use disorders and fatal overdoses. Identifying non-opioid medications for the management of chronic pain with minimal abuse liability is a public health necessity, and cannabinoids are a promising drug class for this purpose. More than 80% of medicinal cannabis users report pain as their primary medical indication. These patients tend to seek products that are low in delta-9-tetrahydrocannabinol (THC; the primary psychoactive, and thus intoxicating, component of cannabis), and high in cannabidiol (CBD), a cannabinoid that purportedly has therapeutic benefit for pain but does not produce intoxicating effects [1]. However, there are few well-controlled human laboratory studies assessing the efficacy of high-CBD cannabis for pain in the context of abuse, and even less is known regarding the effects of daily repeated use of cannabis on pain and its relationship to abuse liability. The proposed randomized, within-subjects, placebo-controlled 16-day crossover inpatient human laboratory pilot study (N = 16 healthy cannabis users; 8 men, 8 women) will address important gaps in our understanding of the potential therapeutic utility of cannabis for pain: 1) If repeated cannabis use can result in hyperalgesia; 2) If tolerance to the analgesic and abuse-related effects of cannabis develops and is reversible. Two distinct modalities of experimental pain will be assessed: The Cold Pressor Test (CPT) and Quantitative Sensory Testing Thermal Temporal Summation (QST-TTS), and participants will smoke cannabis 3x/day. Throughout the study, experimental pain and abuse-related effects will be assessed, as will sleep and subjective mood assessments.

NCT ID: NCT04529759 Completed - Tolerance Clinical Trials

Healthy Term Infants Fed Milk-Based Infant Formula

Start date: September 12, 2020
Phase: N/A
Study type: Interventional

This is a randomized, controlled, double-blind, parallel, feeding study with the purpose to evaluate the tolerance of healthy term infants fed partially hydrolyzed whey protein infant formulas.

NCT ID: NCT04499482 Completed - Safety Issues Clinical Trials

Safety and Tolerability of Soy Fiber

Start date: October 4, 2021
Phase: N/A
Study type: Interventional

This is a dose escalation trial in the elderly with obesity to determine the maximum tolerated dose of a novel dietary fiber from whole young soy pods (soy) delivered in foods.

NCT ID: NCT04300699 Not yet recruiting - Quality of Life Clinical Trials

Feasibility of Frailty Assessment and Implementation of Interventions in Women Over 70 With Epithelial Ovarian Cancer

FAIR-O
Start date: June 1, 2020
Phase: N/A
Study type: Interventional

Ovarian cancer is frequently diagnosed in older women, with over half of all new diagnoses being in women over 65 years. Current treatment options are based on the results of clinical trials that often do not include older, less fit patients in whom treatments may be less well tolerated. Further, in older patients the impact of complex medical and social issues is not known. The UK lags behind Europe and the United States in the development of research programs dedicated to improving outcomes for older patients. More research focus is urgently required to improve the assessment and management of older women with ovarian cancer to improve survival outcomes, quality of life and functional independence. Current treatment decisions are made predominantly on age and fitness. However, it has been shown that undertaking a holistic, geriatric assessment of older patients can highlight important issues that would not necessarily be identified in a routine oncology appointment. In this study, we propose to ask oncology teams to undertake a geriatric assessment and specifically address issues that may arise as a result of this. The assessment comprises 8 simple non-invasive assessments that can be performed in the out-patient setting. This approach could result in an important change in clinical practice leading to more holistic assessment of older cancer patients and better address their specific needs and manage their cancer treatment. The long-term goal is to show that pro-actively managing potential issues at the beginning of treatment allows patients to tolerate treatment and maintain their functional independence, leading to improved quality of life.

NCT ID: NCT04294966 Completed - Adolescent Behavior Clinical Trials

Age-Related Effects of THC

ART
Start date: March 10, 2020
Phase: Early Phase 1
Study type: Interventional

Increased accessibility to cannabis and its primary psychoactive constituent THC has raised public health concerns. One major concern surrounds the potential risks associated with acute THC intoxication and who might be most at risk. A second major concern is the need to develop sensitive measures that can detect THC intoxication after recent use and enable robust comparisons of intoxication to determine sources of risk. One potential source of risk is age, specifically during the period of adolescence.

NCT ID: NCT04188782 Completed - Anesthesia Clinical Trials

Tolerance to Sevoflurane in Children Undergoing Repeated Drug Exposure

Start date: November 20, 2019
Phase:
Study type: Observational

Deep sedation or general anesthesia is frequently required for infant that need radiotherapy to treat malignancies. As radiation therapy usually consist of several sessions, these patients are exposure to several consecutive anesthetic exposures (e.g. for some central nervous system tumors 30 sessions of radiotherapy are required). In our center, this 30-min anesthetic exposure are with sevoflurane. Considering that repeated daily exposure to such potent drugs, as general anesthetics, may induce tolerance, it is reasonable to explore whether this phenomenon is occurring in this population. The aim of this observational study was to determine if a repeated exposure to sevoflurane is associated with the development of clinical and electroencephalographic tolerance. We will enroll 16 pediatric patients, and we will measure the time needed to appropriately place the laryngeal mask (clinical effect) and we also will compare the electroencephalographic signal under anesthesia across the different sessions (electroencephalographic effect).

NCT ID: NCT04055363 Completed - Growth Clinical Trials

Human Milk Oligosaccharides (HMOs) Post-market Study on Infants

NEHMO
Start date: October 1, 2018
Phase: N/A
Study type: Interventional

Human milk oligosaccharides (HMOs) represent the third largest solid component of breast milk. Technology advancements made it possible to supplement infant formulas with HMOs (2'FL, LNnT). Two published RCTs have demonstrated that infant formulas supplemented with 2'FL or 2'FL+LNnT are safe, well-tolerated, support normal grow, and may support healthy GI function and confer immune benefits. The performance of HMOs-supplemented formulas assessed in a real-world setting is complementary to previously conducted RCTs conducted in highly controlled clinical settings. Main objectives will be to monitor the safety & tolerance of HMOs-supplemented formulas in larger and diverse infant populations; to assess the performance of HMOs-supplemented formulas in mixed-fed infants, a population that was not studied in previous RCTs but likely represents a relatively common feeding regimen. Finally, considering the potential health/immune benefits of HMOs, it is also important explore the incidences of illnesses (i.e., respiratory illnesses, GI illnesses, and fever) associated with consuming HMOs-supplemented formulas and compare with breastfed infants data.

NCT ID: NCT03952845 Recruiting - Rhinitis Clinical Trials

Intranasal Capsaicinoid Spray

Start date: July 1, 2019
Phase: Phase 1
Study type: Interventional

Rhinitis is inflammation of the inside of the nose. Symptoms of rhinitis include itchiness, sneezing, and a "runny" nose (rhinorrhea). There are many different causes for rhinitis, including allergies, age, different irritants in the air, overacting nervous system, and others. Many current treatments for rhinitis are not helpful or are unable to be used for long periods of time. Capsaicin ("Kap-Sey-Uh-Sin") is a natural product that is found in many spicy foods, including hot peppers. This natural product has been used as a lotion to prevent pain, and scientists have found that it may reduce the symptoms of rhinitis when used as a spray in the nose. However, capsaicin is known to cause a burning sensation. This study is needed so we can figure out what doses of capsaicin cause this burning sensation, and to what level these doses cause discomfort. Capsaicin can also cause a small degree of tearing from the eyes when used as a spray in the nose, and can also cause the nose to become "runny" (rhinorrhea). When the safest dose of capsaicin spray is found, that dose can be used to treat people with rhinitis that is not getting better from standard treatments.