linjc16/ctgov huggingface dataset:
A Registered Cohort Study on Wilson's Disease

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine the clinical spectrum and natural progression of Wilson's Disease in a prospective multicenter natural history study, to assess the clinical, genetic, epigenetic features and biomarkers of patients with Wilson's Disease to optimize clinical management.

Official Title
-----------------
A Registered Cohort Study on Wilson's Disease

Conditions
-----------------
Wilson's Disease

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with the genetic diagnosis of Wilson's Disease Asymptomatic Wilson's Disease carriers Relatives of Wilson's Disease patients or carriers Unrelated healthy controls Participants or Parent(s)/legal guardian(s) willing and able to complete the informed consent process Exclusion Criteria: * Participants are unable to comply with study procedures and visit schedule
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with the genetic diagnosis of Wilson's Disease<br> | Other: No intervention<br>* No intervention<br>|
| Asymptomatic Wilson's Disease carriers<br> | Other: No intervention<br>* No intervention<br>|
| Relatives of Wilson's Disease patients or carriers<br> | Other: No intervention<br>* No intervention<br>|
| Unrelated healthy controls<br> | Other: No intervention<br>* No intervention<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of Unified Wilson's Disease Rating Scale (UWDRS) | Disease severity will be assessed by application of the Unified Wilson's Disease Rating Scale (UWDRS), a clinical rating scale consists of three subscales. Higher UWDRS total scores indicate more severe disease. | Up to 30years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Wilson's Disease, Nature history, Genetics
Effect of Pioglitazone on Testosterone in Eugonadal Men With Type 2 Diabetes Mellitus - A Pilot Study

Study Overview
=================
Brief Summary
-----------------
To study the effects of pioglitazone on the steroidogenic enzyme axis in eugonadal men with type 2 diabetes mellitus.

Detailed Description
-----------------
Several clinical studies demonstrated that pioglitazone not only improves insulin sensitivity but also decreases plasma androgen concentrations (DHEAS and androstenedione) in women with polycystic ovary syndrome (PCOS) . However the reduction in the androgen levels in PCOS is whether secondary to increase in the insulin sensitivity or due to direct effect of thiazolidinediones on steroidogenesis is not known.So far, two human studies have been conducted regarding the effects of rosiglitazone (a thiazolidinedione group of drug) on testosterone level, one in healthy individuals and another was in patients of type 2 diabetes with hypogonadism . But these studies gave equivocal results as the study population were different. Hence we plan to study the effects of pioglitazone on the steroidogenic enzyme axis in eugonadal men with type 2 diabetes mellitus.

Official Title
-----------------
Effect of Pioglitazone on Testosterone in Eugonadal Men With Type 2 Diabetes Mellitus - A Pilot Study

Conditions
-----------------
Type 2 Diabetes Mellitus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HbA1c level of 7.5% or less on stable dosages of sulphonylurea (glimepiride 1-6mg/day) and metformin (1-2g/day) for at least six weeks and BMI of 20-30 kg/m2. Exclusion Criteria: hepatic impairment, coronary artery disease and or heart failure, renal failure, those who requires insulin therapy or HbA1c >7.5%, presence of macular edema and serum albumin <3gm/dL.

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| pioglitazone vs placebo<br>15 patients in pioglitazone group and 15 in placebo group | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pioglitazone effect on testosterone level |  | three months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
eugonadal, testosterone
Glucosamine Sulphate and Increased Level of Blood Cholesterol

Study Overview
=================
Brief Summary
-----------------
Glucosamine sulphate causes no changes in blood levels of cholesterol

Detailed Description
-----------------
The effects on glucosamine sulphate on blood levels of choleterol is measuered in patients with mild to moderate osteoarthritis

Official Title
-----------------
Glucosamine Sulphate and Hypercholesterolaemia

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Drug: Glucosamine sulphate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Osteoarthritic pain, normal blood cholesterol levels - Exclusion Criteria: Systemic diseases, pregnancy, need of medication besides painkillers -

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Glucosamine sulphate|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of blood cholesterol |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of treatment on pain |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
glucosamine sulphate, osteoarthritis, cholesterol,
Phase II Two-step Radioimmunotherapy Clinical Study in Medullary Thyroid Carcinoma

Study Overview
=================
Brief Summary
-----------------
Phase II clinical trial assessing efficacy and toxicity of pretargeted radioimmunotherapy using anti-CEAxanti-DTPA bispecific antibody and di-DTPA-131I peptide in patients with reccurrence of medullary thyroid carcinoma (abnormal calcitonin level and biomarkers doubling time lower than 5 years)

Official Title
-----------------
Phase II Two-step Radioimmunotherapy Clinical Study in Medullary Thyroid Carcinoma

Conditions
-----------------
Thyroid Neoplasms

Intervention / Treatment
-----------------
* Drug: bispecific antibody and di-DTPA-131I


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 -75 years Karnofsky ≥ 70% Histological diagnosis of medullary thyroid carcinoma Calcitonin serum level Ê 100 pg/ml and Calcitonin or CEA doubling time £ 5 years Normal liver and renal functions Granulocytes ≥ 1500/mm3 and platelets ≥ 150 000/mm3 No immunization Consent form signed

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: bispecific antibody and di-DTPA-131I|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Recurrence of medullary thyroid carcinoma: abnormal calcitonin level and biomarkers doubling time lower than 5 years after initial surgery
Ambulatory Oxygen Effects on Muscles in COPD

Study Overview
=================
Brief Summary
-----------------
Patients with chronic obstructive pulmonary disease (COPD) may develop low oxygen levels, because of damage to their lungs. Long term oxygen therapy (LTOT) is given for at least 15 hours per day, and has established indications and benefits in COPD. However, the indications for and benefits from ambulatory oxygen supplementation (oxygen just when walking or exercising) are less well understood, in part due to heterogeneity of previous study designs, and lack of long term follow up. This is a pilot study of supplementary ambulatory oxygen in COPD, which allows us to ascertain mechanisms of disease by measuring their degree of systemic inflammation pre and post oxygen supplementation, and measuring changes in gene expression in muscles by means of microarray profiling. Secondly, our study will utilise follow up of clinical parameters including home activity monitoring to ascertain medium/long term benefits of oxygen supplementation in a real life setting. Our hypothesis is that exertional hypoxia results in muscle dysfunction and this could be prevented by oxygenation.

Official Title
-----------------
Can Muscle Dysfunction in COPD be Altered by Oxygenation in Patients With Intermittent Hypoxia on Exertion?

Conditions
-----------------
COPD

Intervention / Treatment
-----------------
* Drug: Oxygen
* Drug: Medical air equivalent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinical diagnosis of COPD desaturation on exertion Exclusion Criteria: using LTOT immobile for other reason than COPD

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Medical air equivalent<br>Oxygen-nitrogen mix equivalent to medical air when inhaled from a cylinder at 2l/min | Drug: Medical air equivalent<br> <br> |
| Experimental: Oxygen<br>Ambulatory oxygen delivered at 2l/min on any activity performed by the patient, using a blinded cylinder | Drug: Oxygen<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gene expression pattern change between interventions in skeletal muscle biopsy |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Six minute walk test distance |  | 12 weeks | 
| Home activity level as measured by Actigraph |  | 6 and 12 weeks |
Patient Characteristics in Daily Radiological Practice of Gadovist® Application (PATRON)

Study Overview
=================
Brief Summary
-----------------
To evaluate patient characteristics in the current daily radiological practice of Gadovist application. Special focus will be laid on the individual risk factors of patients, the indications for and the dose of Gadovist application. Secondary objective is to prove the known safety profile (especially rare adverse events) of Gadovist and to collect data on handling problems with different application forms (one questionnaire per center).

Official Title
-----------------
Patient Characteristics in Daily Radiological Practice of Gadovist® Application (PATRON)

Conditions
-----------------
Epidemiologic Factors

Intervention / Treatment
-----------------
* Biological: Gadobutrol (Gadovist, BAY86-4875)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with indication for a MRT or MR-Angiography and for whom the radiologist has decided to use the contrast medium Gadovist Exclusion Criteria: No exclusion criteria besides the contraindications for the use of Gadovist as mentioned in the German product information.

Ages Eligible for Study
-----------------
Minimum Age: 7 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br> | Biological: Gadobutrol (Gadovist, BAY86-4875)<br>* Patients with indication for a MRT or MR-Angiography and for whom the radiologist has decided to use the contrast medium gadobutrol<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Profile |  | At day of application | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dosing of Gadovist in different indications |  | At time of application | 
| Adverse Events |  | Throughout and after application | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Drug utilization review
Using Light Therapy to Treat Toe Nail Fungus

Study Overview
=================
Brief Summary
-----------------
To see if four sessions of light therapy successfully treats nail fungus.

Detailed Description
-----------------
This study is a one year study which includes four treatment sessions of light therapy looking for clinical and mycological improvement.

Official Title
-----------------
Noveon Laser Treatment of Onychomycosis: A Device Performance Clinical Study

Conditions
-----------------
Onychomycosis

Intervention / Treatment
-----------------
* Device: light therapy
* Device: light therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: toe nail fungus, not infolving lunula between ages 18-70 years old Exclusion Criteria: not on systemic anti-fungal medications

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Light therapy | Device: light therapy<br>* 6 minute light therapy<br>* Other names: laser threapy;|
| Sham Comparator: 2<br>6 minute session given with machine off | Device: light therapy<br>* combination of wavelengths<br>* Other names: No therapy/machine is off;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical improvement |  | six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mycological negative |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
toe nail fungus
Endoscopy in CKD With Iron Deficiency Anemia

Study Overview
=================
Brief Summary
-----------------
Iron deficiency anemia is very common in CKD patients. Data about gastrointestinal lesions in Arab patients are insufficient.

Detailed Description
-----------------
Iron deficiency anemia without gastrointestinal symptoms needs to be assessed in patients with chronic kidney disease.

Official Title
-----------------
Value of Esophageogastroduodenscopy in Assessment of Chronic Kidney Disease Patients With Iron Deficiency Anemia Without Gastrointestinal Symptoms

Conditions
-----------------
Chronic Kidney Diseases, Iron-Deficiency Anemia

Intervention / Treatment
-----------------
* Procedure: Upper GIT endoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Patients with eGFR is less than 60 ml/m/1.73 m2. Patients with iron deficiency anemia. Absence of gastrointestinal symptoms.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Chronic kidney diseases patients with iron deficiency anemia and eGFR ≥ 60 ml/min/1.73 m2 | Procedure: Upper GIT endoscopy<br>* Upper gastrointestinal endoscpy for all participants and gastric biopsy for histopathological examination for suspicious lesions<br>|
| Group 2<br>Chronic kidney diseases patients with iron deficiency anemia and eGFR < 60 ml/min/1.73 m2. | Procedure: Upper GIT endoscopy<br>* Upper gastrointestinal endoscpy for all participants and gastric biopsy for histopathological examination for suspicious lesions<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of upper gastrointestinal endoscopic findings In chronic kidney disease patients with iron deficiency anemia | Detect rate of upper GIT lesions in asymptomatic CKD patients with iron deficiency anemia using endoscopy followed by biopsy and histopathological examination | 6 months |
Effect of a High-fat Meal on the Pharmacokinetics of SHR3824 and Mass Balance Study in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
This open-label, randomized, two-period, two-treatment (single doses of 10 mg SHR3824 fasted or fed), crossover study was conducted to evaluate the effect of a high-fat meal on the pharmacokinetics of SHR3824 and mass balance study in 12 healthy subjects.

Official Title
-----------------
An Open Label, Randomized, Two-period, Crossover Study to Assess the Effect of Food on SHR3824 and Mass Balance Study in Healthy Volunteers

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Drug: SHR3824


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy. BMI 18-25 kg/m2. Exclusion Criteria: History of clinically significant illness. History of alcohol or drug abuse.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SHR3824 10mg fasted to fed<br>SHR3824 tablet, fasting conditions day 1, visit 2, 7 days wash-out, SHR3824 tablet, high fat, high calorie breakfast day 1, visit 3. | Drug: SHR3824<br>* SHR3824 tablet,10mg, fasting conditions and high fat, high calorie breakfast.<br>|
| Experimental: SHR3824 10mg fed to fasted<br>SHR3824, high fat, high calorie breakfast day 1, visit 2, 7 days wash-out, SHR3824, fasting conditions day 1, visit 3. | Drug: SHR3824<br>* SHR3824 tablet,10mg, fasting conditions and high fat, high calorie breakfast.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The maximum plasma concentration (Cmax) of SHR3824 | Cmax (a measure of the body's exposure to SHR3824) will be compared under fating state and fasted state | Day 1-4 on visit 2 and visit 3 | 
| The area under the plasma concentration-time curve (AUC) of SHR3824 | AUC (a measure of the body's exposure to SHR3824) will be compared under fating state and fasted state | Day 1-4 on visit 2 and visit 3 | 
| The accumulative excretion rate of SHR3824 and its metabolites in urine and feces | Accumulative excretion rate will be compared under fating state and fasted state | Day 1-4 on visit 2 and visit 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of volunteers with adverse events as a measure of safety and tolerability. |  | Up to Day 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SHR3824, food effect, mass, balance, Phase I