linjc16/ctgov huggingface dataset:
Metabolic Changes in Hypothyroid Patients

Study Overview
=================
Brief Summary
-----------------
Hypothyroidism is a frequent condition in danish women, but often overlooked. Along with fatigue one of the main symptoms is weight gain as a result to significantly decreased energy expenditure. This study was undertaken to elucidate changes in glucose, lipid and amino acid turnover in these patients.

Official Title
-----------------
Impact of Hypothyroidism on Glucose, Lipid, and Amino Acid Turnover

Conditions
-----------------
Hypothyroidism

Intervention / Treatment
-----------------
* Drug: L-thyroxine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newly diagnosed hypothyroidism with tsh over 40 mU/L, etiology chronic autoimmune thyroiditis Healthy controls matched regarding sex, age and body mass index Exclusion Criteria: Pregnancy, breastfeeding

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

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

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

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

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>11 hypothyroid patients, newly diagnosed, examined before and after treatment | Drug: L-thyroxine<br>* The hypothyroid patients receive usual treatment with L-thyroxine in our out patient clinic. The doctors there subscribe the medication, this study has no protocol regarding this, we observe the patients again after having been biochemically euthyroid for at least two months.<br>|
| No Intervention: 2<br>10 healthy controls | |

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
-----------------
hypothyroidism, glucose turnover, clamp, insulin resistance, lipid turnover, amino acid turnover
Comparison of HES 130 in Balanced and in Unbalanced Solution

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy of HES 130/0.42 in an electrolyte infusion in comparison to HES 130/0.4 in a sodium chloride infusion.

Official Title
-----------------
Prospective, Randomized, Double-blind, Controlled, Multicenter Study on the Efficacy and Safety of HES 130/0. 42 in a Balanced Electrolyte Solution vs a HES 130/0.4 in a Sodium Chloride Solution in Elective Surgery Patients

Conditions
-----------------
Decreased and Nonspecific Blood Pressure Disorders and Shock

Intervention / Treatment
-----------------
* Drug: 6% HES 130/0.42 in plasma adapted Ringer's solution
* Drug: 6% HES 130/0.4 in a saline solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: Male or female (non pregnant) patients; between 18 and 70 years Elective non-cardiac surgery (except pancreatic or neurological surgery) with an estimated operation duration of 2 hours or longer General anesthesia Voluntary consent Exclusion: Patients of ASA-class III or IV, Cardiac insufficiency NYHA classes III. IV BMI < 18 or > 29 Patients with daily urine output < 1L Patients on hemodialysis Abnormal liver or renal function (i. e. above upper limit of normal range) Abnormal coagulation function (prothrombin time (PT) 3 seconds higher than normal or activated partial thromboplastin time (APTT) 10 seconds higher than normal) Hgb < 10g/dl or HCT < 30% Potassium, sodium or chloride above the upper limit of normal of the laboratory History of diabetes mellitus Known history of a mental or neurological disorder, such as epileptic seizures. History of hypertension and/or taking a beta-receptor blocker or history of atrial fibrillation Patients with known hypersensitivity and with contraindications to HES or any of the excipients

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: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>6% HES 130/0.42 in plasma adapted Ringer's solution (balanced solution) | Drug: 6% HES 130/0.42 in plasma adapted Ringer's solution<br>* 60 g/l hydroxyethyl starch 130 dissolved in plasma adapted Ringer's solution (balanced solution)<br>|
| Active Comparator: 2<br>HES 130/0.4 in a saline solution | Drug: 6% HES 130/0.4 in a saline solution<br>* 60 g/l Hydroxyethyl starch (HES) with a mean molecular weight of 130 kDalton which is dissolved in a saline solution<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum difference of the mean arterial blood pressure |  | 1 hour |
Characterization of Health Conditions of Visitors of the Montreal Museum of Fine Arts

Study Overview
=================
Brief Summary
-----------------
This study evaluates the effects of arts on the Montreal Museum's clients.

Detailed Description
-----------------
Acting early in the process of weakening elders in order to keep them longer in good health and socially active is possible. During the past decade, museums have become involved in the care of patients by using art to improve their quality of life and well-being. Museums have, thus, emerged as new partners in public health. Very few programs developed by museums have focused on elders. Only one focused on elders in situation of early frailty and demonstrated that it was possible, through participatory visual art-based activities, to improve the health status of elders living at home.

Official Title
-----------------
Characterization of Health Conditions of Visitors of the Montreal Museum of Fine Arts: A Prevalence Survey

Conditions
-----------------
Prevention, Health Promotion

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Being 50 years old Coming at Montreal Museum of Fine Arts for guided visits, arts activities, and so forth. Exclusion Criteria -No internet connection and electronic device like cell phone, Ipad or computer.

Ages Eligible for Study
-----------------
Minimum Age: 50 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 |
| --- | --- |
| Observational<br>All participants who go to the Montreal Museum of Fine Arts will fill out an online questionnaire called: CESAM ( Self Administered Questionnaire). This questionnaire will asse participant's health condition. Moreover, the goal of the questionnaire is to evaluate if art activities may change the participants' health conditions in time. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health Condition | Health condition will be evaluates based on a questionnaire called: CESAM(Self Administered Questionnaire). This is an assessment questionnaire that each participant will answer once. The questionnaire is designed that participant's answers to questions are scored. After the answers are summed , the Principal Investigator will obtain an overall measure of participant' health condition. | one month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prevention, museum, art
The Women's Urology Center/WISH Database Project

Study Overview
=================
Brief Summary
-----------------
Comprehensive database from the Women's Urology Center/WISH (Women's Initiative for Pelvic Pain and Sexual Health) program at Beaumont.

Detailed Description
-----------------
This women's health database will help us to identify health issues/concerns, useful therapies and interventions, and identify areas for improvement or further research specific for women's health. It will allow evaluation of outcomes of clinical interventions to enhance the care and treatment of women with pelvic pain and sexual health concerns.

Official Title
-----------------
The Women's Urology Center/WISH Database Project

Conditions
-----------------
Interstitial Cystitis, Sexual Dysfunction, Pelvic Pain, Incontinence

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All Women's Urology Center or WISH patients will be included in this database over time. Exclusion Criteria: The only exclusion would be if specified by a patient upon consent to treatment in the Women's Urology Center or WISH program

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

Sexes Eligible for Study
-----------------
Female

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Interstitial Cystitis, Sexual Dysfunction, Vulvodynia, Pelvic Pain, incontinence
Forefoot Adduction (FFA) in Infants and Toddlers. Differences of Neuromuscular Activity.

Study Overview
=================
Brief Summary
-----------------
Every week we encounter with 5-8 pairs of worried parents of infants with forefoot adduction. Most of them usually need only reassurance and education how to manipulate the deformed foot. During the examination we usually use provocative maneuver to trigger peroneal activity. This manual stimulation usually reveals active eversion and dorsiflexion of the foot in most of the children, but not in all of them. Small part of the children reacts in opposite direction - instead of the typical eversion they demonstrate inversion and some plantar flexion of the foot. We have the impression that this subgroup of children improves the deformity slower and sometime less complete than most of the children. We did not find in the literature any description of this phenomenon. We postulate, that atypically reacting patients probably have different response due to abnormalities of neuromuscular balance between invertors-flexors and evertors-extensors muscle groups. This small subgroup of children may need more close follow-up and probably casting to speed up and secure the improvement of their deformity. Study goals: Evaluate ability of children with FFA to respond on mechanical triggering of peroneal activity The majority of the patients with standard reaction - foot dorsiflexion and eversion (evertors) The minority of the patients with nonstandard reaction - foot plantarflexion and inversion (invertors) Evaluate randomly selected children from each group for character of muscular response on electrical stimulation (EMG) of calf muscles.

Official Title
-----------------
Difference of Neuromuscular Activity in Infants and Toddlers With Foot Dorsiflexion Compare to Infants and Toddlers With Foot Plantarflexion

Conditions
-----------------
Forefoot Adduction

Intervention / Treatment
-----------------
* Other: mechanical triggering of peroneal activity


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Boys and girls between two months and one year old. Non associated pathology. Signing Informed consent. Exclusion Criteria: Unwillingness to sign informed consent. Associated pathology

Ages Eligible for Study
-----------------
Minimum Age: 2 Months
Maximum Age: 1 Year

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| evertors, invertors<br> | Other: mechanical triggering of peroneal activity<br>* mechanical triggering of peroneal activity<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Efficacy of Nutritional Supplement VIUSID/ALZER in Patients With Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate whether Viusid/Alzer Nutritional supplements, could improve the progression disease, in patients with Parkinson's Disease (PD).

Detailed Description
-----------------
Periodical measures of the clinical features with UPDRS will be done at the beginning, each three months until two years. Each group will be compare to evaluate.

Official Title
-----------------
Efficacy of Nutritional Supplement VIUSID/ALZER in Patients With Parkinson's Disease

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Dietary Supplement: VIUSID/ALZER
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with clinical of PD, with the criteria of Brain Bank of London with early stage. Informed consent. Exclusion Criteria: Presence of another disease not well controlled. Patient with atypical features. Patient with advanced Parkinson's disease.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 90 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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: B<br>Placebo | Dietary Supplement: Placebo<br>* Placebo Viusid and Placebo Alzer, 3 per day, oral, one year<br>|
| Experimental: A<br>VIUSID/ALZER. The purpose of the study is to evaluate whether Viusid/Alzer Nutritional supplements, could improve the progression disease, in patients with early PD by UPDRS motor | Dietary Supplement: VIUSID/ALZER<br>* VIUSID/ALZER, 3 per day, oral, one year<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Periodical measures of the clinical features with Unified Parkinson Disease Rating Scale (UPDRS) will be done at the beginning, every three months until one year (end of the treatment) |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hoehn-Yarh will be done at the beginning, every three months until one year (end of the treatment) |  | one year | 
| Dosage levodopa will be done at the beginning, every three months until one year (end of the treatment) |  | one year |
Evaluation of Thoracolumbar Interfascial Plane Block for Postoperative Analgesia After Herniated Lumbar Disc Surgery

Study Overview
=================
Brief Summary
-----------------
Several regional anesthesia have been shown to improve postoperative outcomes in many studies. The transversus abdominis plane (TAP) block provides anesthesia to the abdominal wall by introducing local anesthetic to the anterior rami of the spinal nerve roots. This work evaluates the analgesic effects gained after performing thoracolumbar interfacial plane block (analogous to the TAP block but intended for the back) which targets the sensory component of the dorsal rami of the thoracolumbar nerves in patients undergoing back surgeries.

Official Title
-----------------
Evaluation of Thoracolumbar Interfascial Plane Block for Postoperative Analgesia After Herniated Lumbar Disc Surgery

Conditions
-----------------
Postoperative Analgesia After Disc Surgery

Intervention / Treatment
-----------------
* Procedure: Thoracolumber interfascial plane block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with ASA 1 or 2 aged between 21years old up to 60 years old of both sex scheduled of back surgery Exclusion Criteria: Exclusion criteria will be patients refusal or inability to give an informed consent , history of relevant allergy to any of the drugs used in the procedure , previous lumbar spine surgery or back surgery with planed spinal fixation.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 60 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: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention<br>Thoracolumber interfascial plane block | Procedure: Thoracolumber interfascial plane block<br>* Thoracolumber interfascial plane block versus placebo<br>|
| No Intervention: Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Score |  | 24 hrs postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total morphine consumption |  | 24 hrs postoperative |
Atazanavir Twice Daily

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical research study is to assess the pharmacokinetics of atazanavir administered twice-daily relative to historical data from atazanavir/ritonavir 300/100 mg, given once daily.

Official Title
-----------------
Randomized, Open-Label, Multiple-Dose Study to Evaluate the Pharmacokinetics of Atazanavir Administered Twice-Daily in Health Subjects

Conditions
-----------------
HIV Infections, Protease Inhibitor

Intervention / Treatment
-----------------
* Drug: Atazanavir Sulphate
* Drug: Atazanavir Sulphate
* Drug: Atazanavir Sulphate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and female subjects between the ages of 18 to 45 years old with a BMI of 18 to 30 kg/m2

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A1<br> | Drug: Atazanavir Sulphate<br>* Capsules, Oral, 200 mg, twice daily, 7 days.<br>* Other names: Reyataz;|
| Active Comparator: A2<br> | Drug: Atazanavir Sulphate<br>* Capsules, Oral, 300 mg, twice daily, 8 days.<br>* Other names: Reyataz;|
| Active Comparator: A3<br> | Drug: Atazanavir Sulphate<br>* Capsules, Oral, 400 mg, twice daily, 9 days.<br>* Other names: Reyataz;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the pharmacokinetics (PK) of atazanavir administered twice-daily (BID) relative to historical data from atazanavir/ritonavir 300/100 mg, given once-daily. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the dose proportionality and the diurnal variation in the PK of atazanavir given BID |  |  | 
| Assess the effect of atazanavir BID on bilirubin values and explore the relationship between bilirubin and atazanavir dose level/exposure by UGT1A1 genetic isoform |  |  | 
| Assess the effect of atazanavir BID on metabolic parameters |  |  | 
| Assess the safety and tolerability of atazanavir when administered BID |  |  |
A Phase 2 Trial of ALIMTA (Pemetrexed) in Locally Advanced or Metastatic Recurrent Transitional Cell Carcinoma of the Urothelium

Study Overview
=================
Brief Summary
-----------------
Patients with bladder cancer will be participating in this study for the treatment of abnormal cells in the bladder that have returned after initial treatment OR have moved to a new site in the body.

Conditions
-----------------
Urologic Neoplasms, Metastases, Neoplasm

Intervention / Treatment
-----------------
* Drug: pemetrexed


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: You must have been diagnosed with bladder cancer that has recurred or moved to a new part of the body. You must have at least one tumor that can be physically measured or scanned by x-ray. You may not have had previous chemotherapy (drug) treatment OR you have had surgery followed by one chemotherapy treatment at least 4 months ago. Exclusion Criteria: You may not have used an experimental medicine or device within the past month. Cancer that has spread to your brain. If you are unwilling or unable to take folic acid or vitamin B12 supplements.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: pemetrexed|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
-----------------
Bladder Cancer, Metastatic, Recurrent, Transitional cell carcinoma of the urothelium