linjc16/ctgov huggingface dataset:
Prevention of Weight Gain

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test methods for preventing weight gain in normal-weight and overweight women aged 25 through 44. Participants will complete brief questionnaires about their health, eating and exercise habits, and use of weight control strategies. They will then be randomly assigned to 1 of 3 treatment conditions. All 3 treatments receive information on the importance of maintaining a healthy body weight, the components of a healthy diet, and ways to increase activity levels. The 3 treatment differ in how this information is delivered. At 12, 24 and 36 months after enrolling in the study, participants will attend assessment sessions. They will complete questionnaires and have body weight measured.

Official Title
-----------------
Prevention of Weight Gain in Women Aged 25 Through 44

Conditions
-----------------
Obesity, Body Weight Changes

Intervention / Treatment
-----------------
* Behavioral: Weight Gain Prevention for Women Project


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body mass index of 21 through 30 Exclusion Criteria: Presence of chronic disease that precludes regular physical activity or changes in dietary intake Currently receiving treatment for psychological disorder Currently pregnant or having given birth within last 12 months Use in last 3 months of weight loss medications or other drugs that affect body weight Participation in a weight loss program in last 12 months Planning to relocate outside the study area in the next 3 years

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 44 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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Weight Gain Prevention for Women Project|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
-----------------
weight gain
A Rheumatoid Arthritis (RA) Study Treating Signs and Symptoms of RA in People With RA & Receiving Methotrexate

Study Overview
=================
Brief Summary
-----------------
This clinical study is investigating AMG 719, an investigational drug, for the treatment of patients who have Rheumatoid Arthritis and who are taking Methotrexate. AMG 719 is a drug which is self-injected beneath the skin (similarly to the way insulin is self-injected by diabetics). Patients on this study are on study for 28-weeks. They visit the study facility at least 11 times while participating in the study.

Official Title
-----------------
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study to Assess the Efficacy, Safety and Tolerability of AMG 719 in Subjects With Rheumatoid Arthritis Receiving Methothrexate

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: AMG 719
* Drug: AGM 719
* Drug: AMG 719
* Drug: placebo to AMG 719


Participation Criteria
=================
Eligibility Criteria
-----------------
Men or women, at least 18 years of age at screening Diagnosed with Rheumatoid Arthritis, with a disease duration of at least 24 weeks, receiving methotrexate, and having no recent history of substance or alcohol abuse

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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 50 mg<br>50 mg 3 times weekly | Drug: AMG 719<br>* 50 mg 3 times weekly<br>|
| Experimental: 400 mg<br>400 mg 3 times weekly | Drug: AMG 719<br>* 400 mg 3 times weekly<br>|
| Experimental: 200 mg<br>200 mg 3 times weekly | Drug: AGM 719<br>* 200 mg 3 times weekly<br>|
| Placebo Comparator: Placebo<br>Placebo comparator associated with each active arm. (3:1 active vs placebo) | Drug: Placebo<br>* Placebo given 3 times weekly<br>Drug: placebo to AMG 719<br>* Placebo dose given 3 times weekly<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AMG 719 has a favorable safety profile in subjects with RA receiving methotrexate. |  | Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the effects of multiple doses of AMG 719 relative to placebo on signs and symptoms of RA |  | Week 24 |
Efficacy and Safety of Hydromorphone Hydrochloride Extended-Release Compared to Placebo in Subjects With Persistent Pain

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to assess the efficacy and safety of 8 mg Hydromorphone Hydrochloride Extended-Release.

Detailed Description
-----------------
The primary efficacy objective of this study is to compare the time to emergence of inadequate analgesia of 8 mg Hydromorphone Hydrochloride Extended-Release taken once every 24 hours versus placebo in the treatment of patients with persistent pain who require an opioid medication for control of their pain.

Official Title
-----------------
A Study of the Efficacy and Safety of 8 Mg Hydromorphone Hydrochloride Extended-Release Compared to Placebo in Subjects With Persistent Pain

Conditions
-----------------
Chronic Non-Malignant Pain

Intervention / Treatment
-----------------
* Drug: Hydromorphone Hydrochloride Extended-Release


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: persistent, moderate-to-severe noncancer related pain requiring continuous analgesia for weeks to months, or longer, who are currently taking 20 to 40 mg of oxycodone or opioid equivalents per day for control of their persistent pain and who are willing to accept the possibility of receiving placebo during the Double-Blind Phase Exclusion Criteria: Patients already receiving opioid medication at an average total daily dose greater than 40 mg of oxycodone or opioid equivalents during the last week prior to study entry. Other protocol-specific exclusion/inclusion criteria may apply.

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: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Hydromorphone Hydrochloride Extended-Release|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to emergence of inadequate analgesia. Emergence of inadequate analgesia is defined as one or more of the following: a) the subject has a rating of poor or fair on the Patient Global Assessment of Pain Medicatio |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Global Assessment of Pain Medication |  |  | 
| Pain Control Questionnaire |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic non-malignant pain, opioid
DERMALIX Efficacy on Diabetic Foot Ulcers

Study Overview
=================
Brief Summary
-----------------
(DERMALIX) (Patent number: PCT/TR2014/000251) is a bioactive wound dressing that was developed by Ege University School of Pharmacy Department of Pharmaceutical Technology. This dressing has been categorised as Class III medical device. This clinical study will be conducted in patients with diabetic foot ulcers.

Official Title
-----------------
Clinical Evaluation of the Wound Dressing Impregnated With Microparticules (DERMALIX) on Diabetic Foot Ulcers

Conditions
-----------------
Diabetic Foot, Diabetic Foot Ulcer

Intervention / Treatment
-----------------
* Other: Standard Dressing
* Device: DERMALIX


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 or 2 Patients diagnosed with diabetic foot ulcers Class I and II according to Wagner classification No infections confirmed with culture test No osteomyelitis and gangrene in the foot HbA1c values ≤ % 7.5 Not active smoker No planned treatment of hyperbaric oxygen Patients who give consent for the study Exclusion Criteria: Patients with diabetic foot ulcer of class 3,4 and 5 according to Wagner classification Patients who are pregnant or breast-feeding or female who are in reproductive age applying no preservative method Patients who have mental conditions that lead to difficulties in comprehension Patients who may have compliance issues Patients who have been included to another interventional study with drug or medical device

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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
Interventional Model Description: Open label, controlled, randomised, parallel arm study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control<br>Standard dressing | Other: Standard Dressing<br>* Standard dressing is applied for treatment of diabetic foot ulcers<br>|
| Experimental: Treatment<br>Standard dressing + Wound dressing (DERMALIX) | Other: Standard Dressing<br>* Standard dressing is applied for treatment of diabetic foot ulcers<br>Device: DERMALIX<br>* DERMALIX, a class III Medical Device will be applied in addition to standard dressing<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery of the wound 100% | The wound will be completely recovered | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery of the wound 80% | The wound will be recovered by 80% | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetic Foot
Role of Myo-inositol and D-chiro-inositol on Oocyte Quality

Study Overview
=================
Brief Summary
-----------------
Controlled ovarian hyperstimulation with gonadotropins is an integral part of the various stimulation protocols for patients undergoing in-vitro fertilization (IVF) and other Assisted Reproductive Technologies (ART) such as intracytoplasmic sperm injection (ICSI). The hormonal control of multiple follicular growth and maturation is a critical part of ART procedures since it maximizes the yield of embryos to be transferred, thus increasing the cumulative pregnancy rate. Recent studies have shown the efficacy of myo-inositol (MI) supplementation as a simple and highly effective treatment in order to improve oocyte quality in patients undergoing IVF. Indeed, it was previously shown that MI follicular fluid (FF) concentration is a reliable predictor of oocyte quality. High MI concentration in the FF directly correlates with high oocyte and embryo quality. Another stereoisomer of Inositol was successfully used into clinical practice D-chiro-inositol (DCI). In particular, DCI supplementation was used to restore ovulation in hyperglycemic PCOS patients. In the present study we aim to compare MI versus DCI supplementation on oocyte quality of women undergoing IVF-ET

Official Title
-----------------
A Prospective, Randomized, Double Blind, Study on the Clinical Efficacy Myo-inositol Versus D-chiro-inositol in Women Undergoing in Vitro Fertilization Embryo Transfer.

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Dietary Supplement: Myo-inositol
* Dietary Supplement: D-chito-Inositol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women undergoing IVF treatments Body mass index <28 FSH <10IU/L Normal uterine cavity, anatomy and functions Exclusion Criteria: PCOS Stage III or IV endometriosis Premature ovarian failure Poor responder

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 45 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: D-Chiro-inositol<br>Patients will receive 1.2g/day of D-chiro-inositol | Dietary Supplement: D-chito-Inositol<br> <br> |
| Active Comparator: Myo-inositol<br>Patients will receive 4g/day of myo-inositol | Dietary Supplement: Myo-inositol<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of morphologically mature oocytes |  |  | 
| Total international units (IU) of recombinant FSH administrated |  |  | 
| number of grade 1 embryos |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Poor oocyte quality, IVF failure
Confocal Microscopy of Benign and Malignant Skin Tumors

Study Overview
=================
Brief Summary
-----------------
The investigators speculate that this tool may be used as an alternative and convenient non-invasive diagnostic of skin cancer.

Official Title
-----------------
Confocal Microscopy of Benign and Malignant Skin Tumors

Conditions
-----------------
Skin Cancer

Intervention / Treatment
-----------------
* Device: confocal microscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women over the age of 18 Skin lesion suspected to either BCC or SCC etc Patient was referred for biopsy diagnostic/therapeutic before hand, and regardless of confocal microscope examination, according to the clinical consideration of physician Exclusion Criteria: Pregnant women Children

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 |
| --- | --- |
| all study Population<br>all | Device: confocal microscopy<br>* non-invasive imaging<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficacy of a confocal microscope as a diagnostic tool |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
skin lesion suspect as BCC or SCC or others
Use of Hextend in Trauma

Study Overview
=================
Brief Summary
-----------------
This is a chart review of all trauma patients during the specified time period. The purpose of this study is to examine the effects of resuscitation with hextend after trauma, in the adult population. The authors hypothesize that when compared to patients resuscitated with standard of care, resuscitation with Hextend will result in a mortality difference.

Official Title
-----------------
Use of Hextend in Trauma

Conditions
-----------------
Trauma

Intervention / Treatment
-----------------
* Drug: Hextend


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Admission to the trauma center Exclusion Criteria: Pregnant women, children, psychiatric patients and prisoners.

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 |
| --- | --- |
| Hextend<br>Patients that received Hextend as part of their fluid resuscitation. | Drug: Hextend<br>* IV fluid resuscitation to restore euvolemia after traumatic injury and surgery.<br>|
| Standard of Care<br>Patients that received standard fluid resuscitation but no Hextend. | Drug: Hextend<br>* IV fluid resuscitation to restore euvolemia after traumatic injury and surgery.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | Overall inpatient mortality upon discharge from the hospital with a mean length of stay of 8 days. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hextend, Combat casualty care, Colloid
Analysis of Three-dimensional Movements of the Head in Cervical Dystonia

Study Overview
=================
Brief Summary
-----------------
This study addresses postures and range of motion in cervical dystonia (Spasmodic Torticollis). It uses 3D miniature and wireless motion captures sensors, and aims to increase the understanding of the biomechanics of the movement disorders of the cervical column in this pathology. In addition, the clinical state of cervical dystonia of the patients will be assessed, using the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS). The investigators will compare the results between control and study groups.

Official Title
-----------------
Analysis of 3-D Movements of the Head in Cervical Dystonia: Comparative Assessment of the Cervical Mobility With the Mean of 3D Sensors Motion Capture Between Patients With Cervical Dystonia and Control Subjects

Conditions
-----------------
Cervical Dystonia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Segmental cervical dystonia diagnosed by a neurological specialist in movement disorders Exclusion Criteria: Neurological pathology other than cervical dystonia such as Parkinson's disease, head tremor, severe pain or cervical ailment, which would have required a treatment within the last six months Neuroleptic treatment in course Pregnancy breast feeding

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cervical dystonia<br> | |
| matched controlled subjects<br>matched in age (+/- 5 years) and gender | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Range of motion of the voluntary mobility of the cervical spine in the three spatial planes | Range of motion of the voluntary mobility of the cervical spine in the three spatial planes, measured in patients and matched control subjects | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| movements disorders in cervical dystonia | correlations between the movements disorders (range of motion, angular velocity, direction deviation) and the clinical characteristics of cervical dystonia, among patients with cervical dystonia | baseline | 
| head posture | influence of vision on the head posture | baseline | 
| range of motion | influence of vision on the range of motion | baseline |
Efficacy and Safety of Polyethylene Glycol Compared With Sodium Picosulphate for Bowel Preparation Before Colonoscopy

Study Overview
=================
Brief Summary
-----------------
Patients intended for ambulatory colonoscopy will be randomized into 2 groups

Official Title
-----------------
Efficacy and Safety of Polyethylene Glycol Compared With Sodium Picosulphate for Bowel Preparation Before Colonoscopy, a Prospective Randomized, Controlled Study

Conditions
-----------------
Bowel Preparation

Intervention / Treatment
-----------------
* Drug: Sodium Picosulphate
* Drug: Polyethylene Glycol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ambulatory patients scheduled for elective colonoscopy Age 18-80 Exclusion Criteria: Renal insufficiency (serum creatinine ≥2.0 mg/dl) Symptomatic congestive heart failure Recent myocardial infarction

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Polyethylene glycol<br>Preparation with Polyethylene Glycol and bisacodyl | Drug: Polyethylene Glycol<br>* 3 Liters solution<br>* Other names: Go-Lytely;|
| Experimental: Picolax<br>Preparation with Sodium Picosulphate and Bisacodyl. | Drug: Sodium Picosulphate<br>* 2 Sachets<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients requiring repeat colonoscopy because of poor preparation | Quality of preparation: good, moderate, poor | quality of preparation will be assessed during colonoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient's satisfaction as measured by questionnaire and willingness to repeat same preparation on future examination | Patient satisfaction on questionnaire referring to taste, compliance with protocol, side effects, willingness to repeat preparation. | Questionnaire will be filled before colonoscopy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
colonoscopy, Cathartics, Sodium picosulfate, Polyethylene Glycol