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NCT ID: NCT01977820 Terminated - Phenylketonuria Clinical Trials

Sapropterin on Cognitive Abilities in Young Adults With Phenylketonuria

SIGNAL
Start date: February 2014
Phase: Phase 2
Study type: Interventional

This is a Phase 2a multicenter, double-blind, placebo-controlled, randomized, 2-arm pilot trial designed to assess the effect of sapropterin on cognitive abilities in young adults with Phenylketonuria (PKU) over a 26-week treatment period.

NCT ID: NCT01977313 Completed - Clinical trials for Polymorphism, Genetic

Genetic Polymorphism of the Androgen Receptor-Gene and Sexual Function in Middle Aged Women

CAG-Libido
Start date: September 2013
Phase: N/A
Study type: Observational

It is known that with increasing age sexual desire is declining in women. Decreasing levels of androgens are believed to have an influence, but cannot explain the loss of libido completely. A possible explanation might be that the effect of the androgen is depending on the functionality of the androgen receptor. It is known that this functionality is genetically determined by the polymorphism of the androgen receptor gene. In the gene there is a varying number of CAG-repeats: the longer the CAG-Repeat, the lower the functionality of the androgen receptor, the lower the effect of the androgens. In this pilot study, the investigators would like to invite 45 healthy heterosexual middle-aged women to the University Hospital of Bern, where they answer questionnaires about their sexual function and where they give a blood sample to assess the testosterone serum levels and the genetically determined androgen receptor subtype. The investigators believe that lower androgen levels and/or longer CAG-repeats in the androgen receptor gene are related to lower libido scores in healthy middle-aged women.

NCT ID: NCT01976741 Completed - Neoplasms Clinical Trials

Dose Escalation Pan-FGFR (Fibroblast Growth Factor Receptor) Inhibitor (Rogaratinib)

Start date: December 30, 2013
Phase: Phase 1
Study type: Interventional

- This was the first study where BAY1163877 was given to humans. Impact of the study was to evaluate if patients with advanced solid cancers show advanced clinical benefit under the treatment with the pan FGFR inhibitor. Patients (all comers) received the study drug treatment in a dose-escalation scheme (no placebo group) to determine the safety, tolerability and maximum tolerated dose (MTD) of BAY1163877. The relative bioavailability of liquid service formulation and tablets was determined. - After the MTD was defined patients with solid tumors (all comers), lung cancer (lung adenocarcinoma & squamous non-small cell lung cancer), head and neck cancer or bladder cancer was enrolled according to their FGFR expression profile (biomarker stratification). - The study also assessed the pharmacokinetics, biomarker status, pharmacodynamic parameters and tumor response of BAY1163877. - BAY1163877 was given twice daily as oral application. Treatment was stopped if the tumor continued to grow, if side effects, which the patient cannot tolerate, occurred or if the patient decided to exit treatment.

NCT ID: NCT01976481 Completed - Skin Toxicity Clinical Trials

Serum 25-OH Vitamin D Modulation by Sunbed Use According to EU Guideline EN 60335-2-27

Start date: November 2013
Phase: N/A
Study type: Interventional

Our study aims to clarify the impact of the use of a standard sunbed according to new EU guideline EN 60335-2-27 and possibly discount the positive effects of tanning beds. We plan to investigate the serum elevation of 25(OH)D under sunbed use, respecting the new recommendations for the exposure plan for different skin types according to EN 60335-2-27. The use of a sunbed will be compared to a control group not using a sunbed in the observation period. - Trial with medical device

NCT ID: NCT01976468 Active, not recruiting - Clinical trials for Squamous Cell Carcinoma

Metastases of Cutaneous Squamous Cell Carcinoma in Organ Transplant Recipients. The "SCOPE-ITSCC Metastases Study"

Start date: November 2013
Phase:
Study type: Observational

The investigators hypothesize that a low number of SCC in OTR will metastasize.

NCT ID: NCT01975727 Terminated - Clinical trials for Postoperative Nausea and Vomiting

Dexamethasone for the Treatment of Established Postoperative Nausea and Vomiting

DexPonv
Start date: September 3, 2012
Phase: Phase 2
Study type: Interventional

Postoperative nausea and vomiting (PONV) are frequent after surgery and anaesthesia. Dexamethasone is widely used as antiemetic for the prevention of PONV. Little is known about the efficacy of antiemetic drugs for the treatment of established PONV symptoms. No single randomised trial has been published so far that tests the efficacy of dexamethasone for the treatment of established PONV symptoms. In this trial the investigators want to test the antiemetic efficacy of three different doses of intravenous dexamethasone for the treatment of established PONV symptoms. In adjunct protocols of this study the investigators aim to establish a novel method to quantify the anti-nausea efficacy of an antiemetic drug, to study pharmacogenetics of PONV, and to further our understanding on the smoking status as a predictive factor of PONV.

NCT ID: NCT01975714 Completed - Glaucoma Clinical Trials

Intraocular Pressure and Tolerability Study of Preservative-free Prostaglandins (Bimatoprost and Latanoprost) on Glaucoma and Ocular Hypertension: European, Multicentric, Investigator-led, Single Masked Study

SPORT
Start date: October 2013
Phase: Phase 4
Study type: Interventional

Bimatoprost 0.03% preservative free monodose eye drops solution (BUDPF) is a new product composed of a synthetic prostamide, bimatoprost 0.3% in a preservative free formulation. This new product is used as a once-daily topical ocular therapy for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma, or ocular hypertension, and that are sensitive to preservatives. The individual active component of BUDPF, bimatoprost is an established therapeutic agent with well documented IOP efficacy (1). Prostamides, such as bimatoprost, are believed to lower IOP mainly by increasing uveoscleral outflow. The comparator, Preservative Free Latanoprost 0.005% Unit Dose (LUDPF, eg. Monoprost®), was recently launched in a number of countries in Europe and contains latanoprost in a new preservative free formulation. It is clinically important to compare these newly entered preservative free products with respect to tolerability and efficacy. A better tolerability combined with maximum efficacy will reduce the burden of daily glaucoma therapy and provide a clear therapeutic benefit to the glaucoma patient by providing enhanced compliance and real-world IOP-lowering efficacy. The hypothesis of the study is that monodose bimatoprost is more effective than monodose latanoprost by at least 1 mmHg. (AIBILI applied for an unrestricted grant from Allergan to perform this study)

NCT ID: NCT01975701 Completed - Clinical trials for Recurrent Glioblastoma or Other Glioma Subtypes

A Phase 2 Study of BGJ398 in Patients With Recurrent GBM

Start date: December 9, 2013
Phase: Phase 2
Study type: Interventional

This is an open-label non-randomized, multicenter, phase II study of BGJ398 administered to adult patients with histologically confirmed GBM and/or other glioma subtypes with FGFR1-TACC1, FGFR3-TACC3 fusion and/or activating mutation in FGFR1, 2 or 3.

NCT ID: NCT01975558 Completed - Breast Cancer Clinical Trials

The Radiation Metabolic Signature of Patient Undergoing Radiotherapy. A Pilot Study

Start date: June 26, 2014
Phase:
Study type: Observational

Rationale: Local radiotherapy applied in the treatment of tumors changes the metabolic profile in the exposed area and/or systemically and specific radiation biomarkers can be identified in the respective matrices. Purpose: This is a pilot study to verify in humans the results obtained from two animal models exposed to ionizing gamma-radiation. The classification of patients results from the treatment volume of radiotherapy for cancer disease. Two patient groups with breast cancer undergoing high-dose radiotherapy are selected and compared to control group of age matched healthy women.

NCT ID: NCT01975389 Terminated - Clinical trials for Cardiovascular Disease

The Evaluation of Bococizumab (PF-04950615; RN316) in Reducing the Occurrence of Major Cardiovascular Events in High Risk Subjects

SPIRE-2
Start date: October 29, 2013
Phase: Phase 3
Study type: Interventional

This study evaluates the PCSK9 inhibitor, Bococizumab (PF-04950615;RN316), compared to placebo, in reducing the occurrrence of major cardiovascular events, including cardiovascular death, myocardial infarction, stroke, and unstable angina requiring urgent revascularization in high risk subjects who are receiving background lipid lowering therapy and have cholesterol laboratory values of LDL-C >/= 100 mg/dL (2.6 mmol/L) or non-HDL-C >/=130 mg/dL (3.4 mmol/L).