linjc16/ctgov huggingface dataset:
A Study to Look at Antiepileptic Drug Levels While on Lamictal or Depakote With or Without an Oral Contraceptive

Study Overview
=================
Brief Summary
-----------------
Some antiseizure medication levels are affected by hormones. This study is being done to determine if blood levels of lamotrigine or valproate are affected by the hormones in the birth control pill or the menstrual cycle itself.

Detailed Description
-----------------
Participants will be given informed consent and will be asked to have two blood draws at specific times of the menstrual cycle or if on a birth control pill, during the active and inactive pill phases.

Official Title
-----------------
Variation of Serum Valproate and Lamotrigine Levels in Relation to The Menstrual Cycle and Oral Contraceptive Use

Conditions
-----------------
Epilepsy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be a female between 13-45 years of age Must have a history of seizures Must be taking either lamotrigine (Lamictal) or valproate (Depakote) with or without a birth control pill Exclusion Criteria: Must not be on antidepressant medication, tranquilizers, or other forms of hormonal therapy other than the birth control pill

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 45 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Valproate monotherapy | |
| 2<br>Valproate monotherapy with combined oral contraceptive | |
| 3<br>Lamotrigine monotherapy | |
| 4<br>Lamotrigine monotherapy with combined oral contraceptive | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To carry out a controlled investigation to determine if combined oral contraceptive (COC) use affects serum valproate (VPA) and lamotrigine (LTG) levels |  | 3 years | 
| To distinguish any apparent COC effects from the potential effects of the naturally occurring high (mid luteal) and low (early follicular, menstrual) steroid phases of the menstrual cycle itself |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
epilepsy, menstrual cycle, valproate, lamotrigine, oral contraceptive
Study Evaluating the Safety of FXR-450 in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
The primary purpose of the study is to evaluate the safety of FXR-450 in healthy subjects. This study will also evaluate pharmacokinetics (PK) of FXR-450 in healthy subjects.

Official Title
-----------------
Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of FXR-450 Administered Orally to Healthy Subjects

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: FXR 450
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men or women of nonchildbearing potential (WONCBP) aged 18 to 50 years inclusive at screening. Healthy as determined by the investigator on the basis of screening evaluations. Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must be able to abstain from smoking during the inpatient stay. Exclusion Criteria: Any significant medical disease. History of cholecystectomy (removal of gallbladder). Any clinically important finding in physical examination, vital signs, 12-lead electrocardiograms (ECGs), or clinical laboratory test results.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Arm 1: FXR 450 | Drug: FXR 450<br>* capsule, single oral doses from 10 mg to 450 mg<br>|
| Placebo Comparator: 2<br>Placebo | Drug: placebo<br>* capsule similar to active drug<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety, tolerability |  | 4 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pharmacokinetics |  | 4 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
healthy subjects
Dermacyd PH_DESILSTY_FL (Lactic Acid) - Acceptability - Stay on Floral.

Study Overview
=================
Brief Summary
-----------------
Primary Objective: To prove the safety of the gynaecological formulation in normal conditions of use.

Official Title
-----------------
Monocentric Study, Phase III, for Safety Dermatological Evaluation: Acceptability With Gynaecological Follow up - Dermacyd PH_DESILSTY_FL (Lactic Acid).

Conditions
-----------------
Hygiene

Intervention / Treatment
-----------------
* Drug: LACTIC ACID(ND)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Integral vaginal mucosa in the product analysis region Use the same category cosmetics products Willingness in following the study procedures and to be present in the clinic at the days and scheduled time; Exclusion criteria: Use of Anti-inflammatory, immunossupression or antihistaminics drugs Allergic or atopic history to cosmetics products Cutaneous active disease (local and/or general) in the evaluated area Disease which can cause immunosuppresion, such as diabetes, HIV Endocrinology pathology such as thyroid gland, ovary and adrenal gland Intensive solar exposure until 15 days before evaluation Gynecological treatment until four weeks before the study Other reason considered by the investigator as a reason for not being included. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dermacyd PH_DESILSTY_FL (Lactic Acid)<br>Treatment duration: 21 consecutive days | Drug: LACTIC ACID(ND)<br>* Treatment duration: 21 consecutive days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The absence of irritation and the good acceptability will be evaluated using one specific scale which describes the intensity of the reaction. |  | From the treatment start to the end of the study (treatment period 21 days) |
Benefits of Amantadine in Patients With Coma State

Study Overview
=================
Brief Summary
-----------------
The study was a single center observational-prospective study and approved by local ethics committee. Patients in coma state due to traumatic brain injury, cardiac arrest or ischemic stroke who are older than 18 years of age were included in the study. Patients who received amantadine 200mg/day for fourteen days according to ICU protocols decided by primary physician formed the amantadine group, and the rest of the subjects were included in the control group. All patients were evaluated for Glasgow Coma Score, JFK Coma Recovery Scale and Disability Rating Scale once a week for three months.

Conditions
-----------------
Coma; Prolonged, Amantadine

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥18 years, ≤ 65 years GCS score ≤ 8 Coma state due to ischemic stroke, brain hemorhage, anoxic brain damage Exclusion Criteria: <18 years, > 65 years Patients admitted to the critical care without diagnosis of coma state Patients admitted to critical care with coma state that are not duo to ischemic stroke, brain hemorhage, anoxic brain damage Metastatic malignant neoplazm Congenital or acquired brain function problem (cerebral palsy, autism etc) Patients with amantadine allergy Progressive degenerative diseases (Alzheimer, Parkinson diseases etc)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Amantadine group<br>Patients admitted to the critical care with diagnosis of coma state who have received amantadin 200 mg / day for fourteen days according to İCU protocols decided by primary physician | Drug: amantadine sulphate<br> <br> |
| Control group<br>Patients admitted to the critical care with diagnosis of coma state who haven't received amantadin | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Glascow Coma Score | Glascow Coma Score | 1. At the time of enrollment 2. 12 weeks after the enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coma, Disability, amantadine
A Specialized Diet for the Unique Metabolic Characteristics of Peripubertal African American Girls

Study Overview
=================
Brief Summary
-----------------
A diet (42% carbohydrate) specialized to the unique metabolic characteristics of peripubertal African AMerican girls (hyperinsulinemic, low insulin sensitive) will be more effective in maintaining glucose and insulin homeostasis compared to a standard diet (55% carbohydrate)

Official Title
-----------------
Dietary Intervention to Improve Insulin Dynamics During the Pubertal Transition

Conditions
-----------------
Obesity, Type 2 Diabetes

Intervention / Treatment
-----------------
* Other: Dietary


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: African American girls aged 9-14, Overweight < 90th percentile Exclusion Criteria: On medications known to affect metabolism prior disease diagnosis

Ages Eligible for Study
-----------------
Minimum Age: 9 Years
Maximum Age: 15 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A, 1<br>low-carbohydrate (42%) | Other: Dietary<br>* modification of macronutrient content<br>|
| Experimental: A,2<br>standard carbohydrate (55%) based on ADA recommendations | Other: Dietary<br>* modification of macronutrient content<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| decreased insulin secretion |  | 25 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| decreased markers of inflammation; decreased estradiol concentration |  | 25 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
obesity, puberty, diabetes,insulin dynamics
Sacral Erector Spinae Plane Blocks in Pediatric Patients

Study Overview
=================
Brief Summary
-----------------
Patients who were operated by Department of Pediatric Surgery and who received sacral erector spinae plane blocks as a part of postoperative analgesia management will be scanned.

Detailed Description
-----------------
Erector spinae plane block (ESPB) is a safe and effective regional anesthesia technique in pediatric patients and can be performed at any level of the thoracic and lumbar vertebrae. In addition, ESPB can be performed at the sacral region in the midline. In pediatric patients, sacral ESPB provides effective analgesia and this method can replace caudal blocks. This study aims to investigate the efficacy of sacral ESPB retrospectively. Demographical data of the patient, indication/surgery type, total volume applied, additional analgesic use, type of the analgesic if used will be investigated.

Official Title
-----------------
Retrospective Analyses of Sacral Erector Spinae Plane Blocks in Pediatric Patients: Is it Time to Discuss the Necessity of Caudal Block

Conditions
-----------------
Postoperative Pain

Intervention / Treatment
-----------------
* Procedure: Sacral ESPB


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who were operated by Department of Pediatric Surgery Exclusion Criteria: Incomplete patient forms

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 18 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sacral ESPB<br>Sacral erector spinae plane block performed with 0,25% bupivacaine (1 mL/kg-max 20mL), under general anesthesia before the start of the surgery. | Procedure: Sacral ESPB<br>* Erector spinae plane block performed with 0,25% bupivacaine (1 mL/kg-max 20mL), under general anesthesia before the start of the surgery.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Face, Legs, Activity, Cry, Consolability (FLACC) Scale | The scale is scored in a range of 0-10 with 0 representing no pain (meaning a better outcome). The scale has five criteria, which are each assigned a score of 0, 1 or 2. | Postoperative 24th hour. | 
| Rescue analgesic-paracetamol | The need and amount of the IV paracetamol given | During the postoperative 24th hour. | 
| Rescue analgesic-ibuprofen | The need and amount of the oral ibuprofen given | During the postoperative 24th hour. |
Subcutaneously Administered CAMPATH in CD52 Expressing Hematologic Malignancies

Study Overview
=================
Brief Summary
-----------------
This phase I study will involve escalating doses of CAMPATH until the goal dose for the cohort is tolerated. The CAMPATH goal dose will be administered to the patient subcutaneously (SQ) 3 times per week for up to 12 weeks.

Official Title
-----------------
A Phase I Study of Subcutaneously Administered CAMPATH in CD52 Expressing Hematologic Malignancies

Conditions
-----------------
Hematologic Malignancies

Intervention / Treatment
-----------------
* Drug: CAMPATH (alemtuzumab)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with relapsed or refractory hematologic malignancy. The anticipated patient population are patients with chronic lymphocytic leukemia (CLL), non-Hodgkin's lymphoma or myeloma Patients with a history of a hematologic malignancy that has previously been shown by flow cytometry or immunophenotyping analysis to express CD52 Any chemotherapy, major surgery or irradiation must have been completed at least four (4) weeks before enrollment in this study (6 weeks for mitomycin-C or nitrosourea) Patients have recovered from the acute side effects due to prior therapy Life expectancy of > 3 months World Health Organization (WHO) Performance Status 0-2 18 years of age or older Adequate organ function as defined in the protocol Exclusion Criteria: Prior therapy with CAMPATH Use of an investigational agent within two (2) weeks prior to study enrollment History of anaphylaxis following exposure to humanized monoclonal antibodies Known human immunodeficiency virus (HIV) positive Prior autologous bone marrow or stem cell transplant if within six (6) months of study entry A history or prior allogenic bone marrow transplant or organ transplant Known, symptomatic central nervous system (CNS) involvement with lymphoma Pregnant or lactating women Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (excluding skin infection, lower urinary tract infection, or oral infection), symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: CAMPATH (alemtuzumab)|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
-----------------
CD52 Expressing Hematologic Malignancies
Safety Study of Autologous Bone Marrow Stromal Cells With Modification by Hepatocyte Growth Factor to Treat Silicosis

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to analyze the safety, pulmonary function, and imaging changes of patients with silicosis treated with autologous bone marrow stromal cells with modification by hepatocyte growth factor.

Official Title
-----------------
Phase 1 Study of Autologous Bone Marrow Stromal Cells With Modification by Hepatocyte Growth Factor to Treat Silicosis

Conditions
-----------------
Silicosis

Intervention / Treatment
-----------------
* Other: Cells


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - age between 18-50, chronic and accelerated silicosis, characterized with a fibrotic increase in the last two years, FEV1 <60% and > 40%, FVC > 60% and SaO2 >90% Exclusion Criteria: - smoking, active tuberculosis or other infections, cancer, auto-immune disorders, hematological, hepatic or cardiac diseases, and pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: stromal cells modified HGF<br> | Other: Cells<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absence of lung deficits during the procedure and/or in the 6 months follow-up |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of pulmonary deficits |  | 1 year |
Intragastric Balloon, Air Versus Fluid Filled: Randomized Prospective Study

Study Overview
=================
Brief Summary
-----------------
Gastric balloons are an evolving way of reducing weight. There are two types on the market, up to date. Air filled balloons seem to be more safe, and more tolerable.

Detailed Description
-----------------
Morbidly obese patients are categorized into two groups: the 1st group to whom intragastric air filled balloon and the 2nd group to whom saline filled balloon is applied for treatment of their morbid obesity. The aim of study is to compare both types of balloons regarding safety, efficacy and tolerance.

Official Title
-----------------
Intragastric Balloon, Air Versus Fluid Filled: Randomized Prospective Study

Conditions
-----------------
Morbid Obesity, Weight Loss, Tolerance

Intervention / Treatment
-----------------
* Device: Air filled balloon
* Device: Bioenteric BIB® balloon


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Morbidly obese patients Exclusion Criteria: Patient refused Non compliant patients Psychological patients Oesophageal varices, big hiatus hernia, ulcers Gastric vascular malformations
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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: hemiosphere® BALLOON<br>Balloon filled with air according to the manufacturing company orders 600 or 720 ml air | Device: Air filled balloon<br>* Balloon filled with air according to the manufacturing company orders<br>* Other names: first group;|
| Active Comparator: Fluid filled balloon<br>Balloon filled with saline and methylene blue according to the manufacturing company orders | Device: Bioenteric BIB® balloon<br>* Balloon filled with saline and methylene blue according to the manufacturing company orders<br>* Other names: second group;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerance | Tolerance of the patients toward the balloon regarding vomiting, nausea, dysphagia , gastric pain and dyspepsia | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss | Weight loss by Kg and BMI, | 6 months | 
| Rate of deflation or puncture | Rate of deflation or puncture (in air filled, it well be followed up by x ray every 2 weeks while in saline filled, it well be followed up by observation of blue coloured urine | 6 MONTHS | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Morbid obesity, Gastric balloon, Weight loss, Tolerance, Safety