linjc16/ctgov huggingface dataset:
Thyroid Hormones Effect on Brown Adipose Tissue

Study Overview
=================
Brief Summary
-----------------
Brown adipose tissue (BAT) is important in energy expenditure through thermogenesis although the regulatory factors are not well known in humans. There is evidence suggesting that the thyroid hormones affect BAT functions in lower mammals, but the effects of the thyroid hormones on BAT activity in humans are still unclear. The objective of this study was to investigate the effects of thyroid hormones on glucose metabolism of BAT and other organs in humans.

Detailed Description
-----------------
Twenty consecutive patients with Graves'-caused hyperthyroidism who are newly diagnosed and untreated will be studied at the Endocrine Department of Huashan Hospital, Fudan University. All subjects are screened and examined by two senior investigators. Putative BAT activity is determined by the integrated 18F-fluorodeoxyglucose (18F-FDG) PET-CT. After the first PET scan, hyperthyroid patients will be treated with Methimazole following clinical guidelines. None of them uses beta adrenergic blockade. The initial dose of methimazole employed is 10mg thrice a day. During follow-up, the thyroid hormone levels (free triiodothyronine and free thyroxine) will be measured every twenty days. The PET-CT scans and assessments will be repeated when the symptoms have disappeared and the thyroid hormone levels return to normal range. Then the dose of methimazole will be adjusted accordingly.

Official Title
-----------------
Study on the Relationship Between the Thyroid Hormones and the Activity of Brown Adipose Tissue in Human

Conditions
-----------------
Hyperthyroidism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newly diagnosed and untreated hyperthyroid patients Informed consent was obtained Exclusion Criteria: History of other endocrine diseases Useing beta adrenergic blockade Pregnant women Pacemaker implantation

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
The Use of Intensive Care in Critically Ill Cancer Haematological Patients: TRIAL-OH

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine: Condition of intensive care unit (ICU) admission in patients with haematological malignancies. ICU hospital and up to one year mortality. Assessment of post ICU burden and health related quality at 90-d and 1 year.

Detailed Description
-----------------
To identify prognostic factors of short and medium term mortality, by underlining the respective weights of organ dysfunction and characteristics of underlined malignancy Evaluate the health related quality of life of intensive care survivors(SF36) Impact of intensive care on families burden (HADS, IES). Assess clinicians' satisfaction ( intensivists, haematologists and intensive care nurses) in relation to medical decision-making. Establish the relevance of antifungal treatments.

Official Title
-----------------
Long Term Outcomes in Critically Ill Haematological Patients. The Use of Intensive Care in Critically Ill Cancer Haematological Patients

Conditions
-----------------
Hematological Malignancies

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hematological malignancies hospitalization in ICU age >= 18 years Exclusion Criteria: Patients who have already participated to TRIAL-OH

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival status at one year | survival status (alive or death) at one year | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health related quality of life of patients and their relatives |  | day 90 and 1 year | 
| ICU mortality | survival status at ICU discharge | 1 week (estimated mean time until ICU discharge) | 
| Survival status |  | day 90 | 
| Hospital mortality | survival status at hospital discharge | 3 weeks (estimated mean time until Hospital discharge) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Leukemia, Lymphoma, Bone-Marrow Transplant, Neutropenia, Acute respiratory failure, Mechanical ventilation, Post ICU burden, ICU triage, Dialysis, Septic shock
Observational Study in Patients With HIV Infection Type 1 After Switching to a Viramune®-Containing Therapy Regimen

Study Overview
=================
Brief Summary
-----------------
Observational study to collect data on maintaining anti-retroviral activity (quantitative HIV RNA determination) and immunological activity (CD4 cells) despite switching from protease inhibitor to nonnucleoside reverse transcriptase inhibitor (NNRTI) (Viramune®).

Official Title
-----------------
Collecting Data in Patients With HIV Infection Type 1 After Switching From a Protease Inhibitor-containing Therapy Regimen and a Viral Load Below Detection Level to a Viramune®-Containing Therapy Regimen

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Viramune


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult male or female patients with HIV type 1 infection Exclusion Criteria: Counter-indications according to summary of product characteristics (SPC) for Viramune tablets No persons under 18 Pregnancy and breast-feeding Use of oral contraceptives Use of drugs affecting CYP450 3A metabolism

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Viramune<br> | Drug: Viramune<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in viral load (HIV-RNA) |  | Baseline, after 26 and 52 weeks | 
| Change in CD4 cell count |  | Baseline, after 26 and 52 weeks | 
| Change in lipid status (lipodystrophy, triglycerides, cholesterol) | verbal rating scale | Baseline, after 26 and 52 weeks | 
| Change in glucose tolerance | verbal rating scale | Baseline, after 26 and 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of subjective well-being | verbal rating scale | up to 52 weeks | 
| Assessment of tolerability by physician and patient | verbal rating scale | after 26 and 52 weeks | 
| Number of patients with adverse events |  | up to 52 weeks |
Comparison of Different Concentrations of Carbamide as Moisturizers in Ichthyosis Vulgaris

Study Overview
=================
Brief Summary
-----------------
A randomized double blinded clinical trial will be conducted comparing the effect of two simple basic moisturizers only different in the concentration of carbamide (urea). The concentrations of carbamide will be tested are 0 and 7.5, respectively. The study will be conducted as a split-body-study and will contain two arms randomized to comparing 0 and 7.5 % carbamide, respectively. Approximately 20 patients with at least clinically verified Ichthyosis Vulgaris will be enrolled to each study arm. The effect of the moisturizers will be assessed by clinical examination (score), patients assesment of effect and measurement of transepidermal water loss (TEWL) and other skin parameters.

Official Title
-----------------
Double Blinded Randomized Clinical Study of Carbamide as Moisturizer in Ichthyosis Vulgaris

Conditions
-----------------
Ichthyosis Vulgaris

Intervention / Treatment
-----------------
* Device: 7.5 %


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinically diagnosed with Ichthyosis Vulgaris Exclusion Criteria: All other forms of Ichthyosis
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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Only moisturizer, no carbamide<br>20 patients with Ichthyosis Vulgaris at age 0-80 years old. One body half | |
| Active Comparator: Moisturizer + 7,5 % carbamide<br>20 patients with Ichthyosis Vulgaris at age 0-80 years old. Other body half | Device: 7.5 %<br>* Patient untreated with moisturizers for 1-2 weeks will start applying moisturizers containing urea at concentration 0 % on one half of the body twice a day while applying the same moisturizer with 7.5 % urea on the other half of the body in the same quantity at the same frequence<br>* Other names: Carbamide = Urea;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin dryness | Transepidermal water loss ('TEWL) (g/m2/h) | 2-8 weeks |
Screening for Social Weaknesses and Coordination Course of Cancer Patients

Study Overview
=================
Brief Summary
-----------------
The main objective of the study is to validate a methodology with Psychometric tool to measure levels of patients social fragility. This tool will be dematerialized on a tablet. The answers will be then processed by a decision support algorithm, which automatically send an alert to detection of social fragility of the patient to the nurse navigators.

Official Title
-----------------
Screening for Social Weaknesses and Coordination Course of Cancer Patients: A New Approach by an Expert System IT

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Other: Questionnaire and interview


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All new patients enter ICLN for a diagnosis of cancer Patients who can read French or patients who can not read French, but accepting the translation by a close friend or family Patient having signed a free and informed consent Exclusion Criteria: Refusal of participation, major patients protected under guardianship. Patient can not read French without possibility of translation by a close friend or family

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: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Questionnaire and interview<br>The patient complete the questionnaire on the tablet to better know their social situation and any difficulties. Then, he will be interview during thirty minutes with a social worker and a nurse navigator. At the end of this intervention we will be offered to the patient monitoring and appropriate resources to its situation. | Other: Questionnaire and interview<br>* The aim is to detect social fragility.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaire validity | Outcomes are content validity by expert judges method, appearance validity through a consensus, construct validity through exploratory factor analysis, discriminant validity in relation to the social fragility through univariate analysis, internal validity through factor analysis | 1 hour |
Side Effects of Pulmonary Hypertension Medications

Study Overview
=================
Brief Summary
-----------------
The study seeks to analyze the patient reported effects of pulmonary hypertension medications and compare these with the side effects described on the package inserts. Side effects for these PH medications have been described in the adult population, but have never been described in the pediatric population. This information can better improve patient care and be used to characterize the side effects resultant from these medications.

Detailed Description
-----------------
As part of standard of care, patients are routinely asked about any symptoms they might be experiencing. This study seeks to quantify these symptoms for research purposes. Participants will be identified through those who attend the pediatric pulmonary hypertension clinic at LPCH. Only children who are currently on one of seven PH medications (Bosentan, Epoprostenol, Letairis, Sildenafil, Tadalafil, Treprostinil, Ventaris) will be approached. Patients who consent to be in the study will answer a brief series of questions pertaining to the presence and duration of their symptoms. These will be correlated to a list of side effects taken from Lexicomp (a medication database).

Official Title
-----------------
Patient Reported Side Effects of Pulmonary Hypertension (PH) Medications

Conditions
-----------------
Pulmonary Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pulmonary hypertension currently taking at least one of the following PH medications (Bosentan, Epoprostenol, Letairis, Sildenafil, Tadalafil, Treprostinil, Ventaris) Exclusion Criteria: >18 years

Ages Eligible for Study
-----------------
Maximum Age: 18 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 |
| --- | --- |
| Study<br>Pediatric patients with pulmonary hypertension | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients Experience Side Effects |  | Open |
Treatment for Obesity and Binge Eating Disorder

Study Overview
=================
Brief Summary
-----------------
This study is a test of cognitive behavioral therapy(CBT) and behavioral weight loss (BWL) treatments for obese patients with binge eating disorder (BED). The study involves a comparison of three treatment conditions: (1) CBT; (2) BWL, and (3) a sequential (two-part) treatment consisting of CBT followed by BWL.

Official Title
-----------------
Treatment for Obesity and Binge Eating Disorder

Conditions
-----------------
Binge Eating Disorder, Obesity

Intervention / Treatment
-----------------
* Behavioral: Cognitive Behavior Therapy
* Behavioral: CBT and BWL
* Behavioral: Behavioral Weight Loss Treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Binge Eating Overweight Exclusion Criteria: Pregnancy Current cardiac disease Serious neurologic illnesses

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Cognitive Behavior Therapy | Behavioral: Cognitive Behavior Therapy<br> <br> |
| Experimental: 2<br>Behavioral Weight Loss Treatment | Behavioral: Behavioral Weight Loss Treatment<br> <br> |
| Experimental: 3<br>CBT + BWL | Behavioral: CBT and BWL<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Binge Eating |  |  | 
| BMI |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
binge eating disorder, cognitive behavior therapy, combination therapy, obesity, weight loss, body weight, clinical trial, dietary restriction, overeating, weight control
Deanxit and Rivotril in Tinnitus Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate whether increased tinnitus reduction can be obtained with Deanxit in patients already receiving Rivotril.

Official Title
-----------------
Additional Value of Deanxit in Tinnitus Patients Treated With Rivotril

Conditions
-----------------
Tinnitus

Intervention / Treatment
-----------------
* Drug: Deanxit
* Drug: Lactose placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pure tone, narrow band noise or polyphonic tinnitus unilateral or bilateral tinnitus VAS ≥ 4 cochleair origin tinnitus tinnitus present 3 months or more age 18y or more intake Rivotril 1mg/d patient 'able to cooperate' patient able to fill in TQ en VAS No pontine angle pathology on MRI Exclusion Criteria: pulsatile tinnitus pregnancy or breast feeding contra-indications Deanxit recovery myocard infarct conduction disorder His untreated glaucoma MAO inhibitors: 15d stop otosclerosis middle ear pathologies Ménière somatic tinnitus

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Lactose placebo<br>1x/day | Drug: Lactose placebo<br>* Lactose used as placebo<br>|
| Experimental: Deanxit<br> | Drug: Deanxit<br>* Deanxit 1x/day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale |  | 3 weeks, 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tinnitus
Pain & Expert: Global Pain-assessment: a Prospective Registry

Study Overview
=================
Brief Summary
-----------------
Full assessment of chronic pain patients based on the ICF-model.

Official Title
-----------------
Pain & Expert: Global Pain-assessment: a Prospective Registry

Conditions
-----------------
Chronic Pain

Intervention / Treatment
-----------------
* Other: Global pain-assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with chronic pain for at least 3 months Age => 18 years Patient has been informed of the study procedures and has given written informed consent Exclusion Criteria: Healthy patients or patients with acute pain. Addiction to drugs, alcohol (>5 units per day) Evidence of an active disruptive psychiatric disorder that may impact perception of pain, and/or ability to evaluate treatment outcome as determined by investigator Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| chronic pain patients<br> | Other: Global pain-assessment<br>* Global pain-assessment, based on the ICF framework<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of a global pain-assessment (i.e. practical use) |  | at the time of the assessment: one day (cross-sectional) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| norm values for chronic pain patients on all aspects of the global pain-assessment will be reported (i.e. descriptives) | Reporting of norm values on the different aspects of the ICF framework in patients with chronic pain | at the time of the assessment: one day (cross-sectional) |
Post-Marketing Surveillance (Usage Results Study) of RIXUBIS in Adult and Pediatric Patients With Haemophilia B in South Korea

Study Overview
=================
Brief Summary
-----------------
Primary: To characterize the safety of RIXUBIS when used under normal clinical care in South Korea. Secondary: To describe hemostatic effectiveness in subjects receiving RIXUBIS under normal clinical care in South Korea.

Official Title
-----------------
Post-Marketing Surveillance (Usage Results Study) of RIXUBIS in Adult and Pediatric Patients With Haemophilia B in South Korea

Conditions
-----------------
Hemophilia B

Intervention / Treatment
-----------------
* Biological: RIXUBIS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants with congenital hemophilia B (FIX level ≤5%) Participant or the participant's legally authorized representative has provided signed informed consent. Participant is indicated for treatment according to the RIXUBIS Korean product leaflet. Exclusion Criteria: Participants with known hypersensitivity or presence of any contraindication to RIXUBIS or its excipients including hamster protein Participants with Disseminated Intravascular Coagulation (DIC) Participants with signs of fibrinolysis
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All Study Participants<br>Participants with congenital hemophilia B (FIX level ≤5%) | Biological: RIXUBIS<br>* Recombinant Factor IX (rFIX) for intravenous use<br>* Other names: BAX 326;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events (AEs) | Seriousness and severity of AEs, including any inhibitory antibody development and/or anaphylactic reactions | Throughout the study period of approximately 2 years and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician rated effectiveness of RIXUBIS for prophylactic treatment in participants <12 years old | Rated on a 4-point ordinal scale: Excellent, Good, Moderate, or none | Up to 6 months from baseline while on treatment | 
| Participant rated effectiveness of RIXUBIS for prophylactic treatment in participants ≥12 years old | Rated on a 4-point ordinal scale: Excellent, Good, Moderate, or none | Up to 6 months from baseline while on treatment | 
| Physician rated effectiveness of RIXUBIS for on-demand treatment in participants <12 years old | Rated on a 4-point ordinal scale: Excellent, Good, Moderate, or none | Up to 6 months from baseline while on treatment | 
| Participant rated effectiveness of RIXUBIS for on-demand treatment in participants ≥12 years old | Rated on a 4-point ordinal scale: Excellent, Good, Moderate, or none | Up to 6 months from baseline while on treatment |