linjc16/ctgov huggingface dataset:
User Evaluation of the Peristomal Skin Condition in Ostomates Using ConvaTec Moldable Technology™

Study Overview
=================
Brief Summary
-----------------
The primary aim of this study is to demonstrate the maintenance of healthy peri-stomal skin over a two month period in subjects who use ConvaTec Moldable Technology™ Skin Barriers as part of their standard protocol of care following surgery.

Official Title
-----------------
Observational User Evaluation of the Peristomal Skin Condition in Ostomates Using ConvaTec Moldable Technology™

Conditions
-----------------
Colostomy, Ileostomy, Urostomy

Intervention / Treatment
-----------------
* Device: Esteem Plus with ConvaTec Moldable Technology
* Device: Natura with ConvaTec Moldable Technology
* Device: Natura Accordion with ConvaTec Moldable Technology
* Device: Esteem synergy Plus with ConvaTec Moldable Technology


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who are 18 years old and older. Subjects who agree to participate in the evaluation and who have signed the informed consent form. Subjects presenting with a stoma (ileostomy, colostomy or urostomy). Subjects for whom ConvaTec Moldable Technology™ per package insert, within the context of routine clinical care is used as the first long-term (within 7 days of ostomy surgery) system following surgery and who have intact peristomal skin (healthy or SACs L1). Exclusion Criteria: Subjects who, according to the investigator, have cognitive problems that prevent them from answering a questionnaire or for whom the evaluation could be a problem. Subjects who are in a simultaneous clinical evaluation.

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

| Intervention/Treatment |
| --- |
|Device: Esteem Plus with ConvaTec Moldable Technology|nan|
|Device: Natura with ConvaTec Moldable Technology|nan|
|Device: Natura Accordion with ConvaTec Moldable Technology|nan|
|Device: Esteem synergy Plus with ConvaTec Moldable Technology|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peri-stomal skin condition at 8-15 days following the application of the barrier. | Using SACs scale to determine incidence and severity of lesions | 8-15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peristomal skin condition in ostomates at 1 month (± 15 days) following the application of the barrier. | Using SACs scale to determine incidence and severity of lesions | 1 month (± 15 days) | 
| Peristomal skin condition in ostomates at 2 months (± 15 days) following the application of the barrier. | Using SACs scale to determine incidence and severity of lesions | 2 months (± 15 days) |
Treatment of Pseudovitellium Detachment With Open-Label Anecortave Acetate Sterile Suspension (15 mg)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to provide compassionate use of anecortave acetate sterile suspension of 15 mg for a series of five patients as a means to control pseudovitelliform detachment.

Conditions
-----------------
Pseudovitellium Detachment, Eye Diseases

Intervention / Treatment
-----------------
* Drug: Anecortave Acetate Sterile Suspension (15 mg)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of patients with pseudovitellium detachment. Patients must be at least 18 years of age. Visual acuity of 20/30 to 20/320 in study eye on the Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity chart Visual acuity of 20/800 or better in fellow eye on the ETDRS visual acuity chart Exclusion Criteria: Patient with significantly compromised visual acuity in the study eye due to concomitant ocular conditions. Patients who have undergone intraocular surgery within the last 2 months. Patient participating in any other investigational drug study. Use of an investigational drug or treatment related or unrelated to their condition within 30 days prior to receipt of study medication. Inability to obtain photographs to document choroidal neovascularization (CNV) (including difficulty with venous access). Patient with significant liver disease or uremia. Patient with known adverse reaction to fluorescein and indocyanine green or iodine. Patient has a history of any medical condition which would preclude scheduled visits or completion of study Patient has had insertion of scleral buckle in the study eye Patient has received radiation treatment Patient is on anticoagulant therapy with the exception of aspirin Patient is pregnant or nursing.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Title: Treatment of Pseudovitellium Detachment<br>Open-Label Anecortave Acetate Sterile Suspension(15mg) | Drug: Anecortave Acetate Sterile Suspension (15 mg)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Title: Treatment of Pseudovitellium Detachment With Open-Label Anecortave Acetate Sterile Suspension (15mg) |  | 24 months |
Assessment of Ultrasonographic Measurement of Inferior Vena Cava Collapsibility Index in Prediction of Hypotension Associated With Tourniquet Release in Total Knee Replacement Surgeries Under Spinal Anesthesia

Study Overview
=================
Brief Summary
-----------------
Administration of intravascular fluids is one of the methods to prevent SA-induced hypotension, but empirical intraoperative volume repletion carries the risk of fluid overload during elective surgery. Over fluid resuscitation is associated with organ dysfunction and higher mortality rate , thus, to avoid ineffective or even harmful intravascular volume expansion, it is important to have tools to predict hypotension and fluid responsiveness.

Official Title
-----------------
Assessment of Ultrasonographic Measurement of Inferior Vena Cava Collapsibility Index in Prediction of Hypotension Associated With Tourniquet Release in Total Knee Replacement Surgeries Under Spinal Anesthesia

Conditions
-----------------
Fluid Hypovolemia, Cerebrospinal

Intervention / Treatment
-----------------
* Diagnostic Test: ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA grade I, II, III Age 18 -65 yrs Spinal Anesthesia Exclusion Criteria: Patient refusal Patient having contraindication of Spinal Anesthesia (infection at the site of injection, spine deformity, coagulation disorders ) . Known cardiac, renal, neurological, metabolic, endocrine, psychiatric, respiratory disease.

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

| Intervention/Treatment |
| --- |
|Diagnostic Test: ultrasound|Ultrasonographic measurement of Inferior Vena Cava Collapsibility Index|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean arterial blood pressure |  | 15 minutes after tourniquet release |
Changes in Footwear Comfort and Performance in High School Football Players

Study Overview
=================
Brief Summary
-----------------
The objective of this proposal is to determine the effects of footwear stiffness on a large cohort of high school football players during a football season. The investigators expect that functional athlete groups will be developed, based on subject specific assessments (biomechanical, morphological, performance, comfort), and lead to important translational findings that may impact footwear modification and recommendation to a population of American football players. Two standard cleats will be randomized and provided during a season of high school football. Ratings of comfort, performance, and injury will be collected throughout the season.

Conditions
-----------------
Foot, Footwear

Intervention / Treatment
-----------------
* Other: Moderate Stiffness Footwear
* Other: High Stiffness Footwear


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participate on a club or school sponsored football team Exclusion Criteria: Current injury that limits sport participation

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 19 Years

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

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Moderate Stiffness<br>Shoe condition that has moderate stiffness | Other: Moderate Stiffness Footwear<br>* Standard moderately stiff footwear for typical high school football players will be randomly allocated to each group<br>|
| Active Comparator: High Stiffness<br>Shoe condition that has high stiffness | Other: High Stiffness Footwear<br>* Standard highly stiff footwear for typical high school football players will be randomly allocated to each group<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Footwear comfort rating using a 100mm visual analog scale | Validated subjective rating of footwear comfort scale. This will be collected weekly during the football season with the average rating utilized at the end of the season. The unit of measure is a 100mm visual analog scale. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Injury incidence | Athletic trainer collected athletic exposures and lower extremity injuries will be collected weekly and combined to determine overall injury rates. The unit of measure is number of injuries per 1000 athletic exposures. | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Football, Cleats, Stiffness
Forearm Vascular Relaxation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to learn the effect of inherited differences on forearm blood flow responses to hormones and drugs

Detailed Description
-----------------
Differences in at least 4 genes are believed to have an important effect on responses to hormones and drugs. For this study, healthy volunteers of normal body weight will be screened to find xxx individuals with the genes of interest. Very small doses of hormones and drugs will be given so that changes in forearm blood flow can be measured, while not causing effects throughout the body. A brachial artery line and venous line will be placed in the study arm so that blood samples may be withdrawn to compare amounts given into the artery and coming out of the vein after circulating through the arm. Forearm blood flow is determined by the rate of swelling of the arm after a blood pressure cuff is inflated (above venous and below arterial blood pressure). The hormones and drugs being studied include angiotensin I, angiotensin II, acetylcholine, sodium nitroprusside, enalaprilat, L-arginine, phenylephrine, endothelin-1, verapamil, and isoproterenol. This procedure will last 4-6 hours. The process will be repeated with the same participant over 2 weeks later.

Official Title
-----------------
Determinants of Forearm Vascular Relaxation: Role of Genetic Polymorphisms

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal physical status without any medical interventions or agents which would alter the defined status of normal Exclusion Criteria: Age less than 21 or greater than 45 Unable to give informed consent BMI (Body Mass Index) less than 18 or greater than 25 Clinically significant abnormal laboratory values Abnormal physical exam Abnormal EKG Pregnancy Smoking or drug usage (illicit or otherwise) Post-menopause Participation in another clinical trial in the past month Chronic Illness

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 45 Years

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

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

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
-----------------
Blood pressure, genetics
A Retrospective Study of Toxicity and Outcome of High Dose Chemotherapy With Autologous Stem Cell Transplant in Patients With Hodgkin Lymphoma (HL).

Study Overview
=================
Brief Summary
-----------------
The majority of patients with Hodgkin Lymphoma (HL)are cured with radiation therapy and/or combination chemotherapy. However, patients who relapse after attaining a complete remission with chemotherapy and those with primary refractory disease have a poor outcome with conventional chemotherapy regimens. Treatment results with standard-dose second-line regimens produce low complete remission rates and minimal survival benefit. Single institution studies have shown better outcome after autologous stem cell transplant in this group of patients when compared to historical controls receiving conventional treatment. In this retrospective review, we aim to analyze outcome and determine independent prognostic factors which would correlate with the long-term outcome of patients with HL who received an autologous stem cell transplant in the past at the Royal Marsden Hospital Eligible patients (those on current-follow-up) identified from the transplant database will be eligible for the study. Accrual of eligible patients currently under follow-up will be performed in clinic at the time of next appointment. All patients accrued will give informed consent to participate in the study for retrospective case note review, after discussion with a study investigator and after receiving a study information sheet. The results of the analysis will be published in a peer-reviewed medical journal.

Conditions
-----------------
Hodgkin Lymphoma

Intervention / Treatment
-----------------
* Procedure: Autologous stem cell transplant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: a) Age over 18 b) Patients with Hodgkin Lymphoma who have received an autologous stem cell transplant c) Informed written consent Exclusion Criteria: a) Medical or psychiatric conditions that compromise the patient's ability to give informed consent b) HIV positive or AIDS related lymphoma

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

| Intervention/Treatment |
| --- |
|Procedure: Autologous stem cell transplant|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
The Effectiveness of Skill-Based HIV Psychoeducation in IV-Drug Abuser for Reducing High-risk Behavior

Study Overview
=================
Brief Summary
-----------------
The Effectiveness of Skill-Based HIV Psychoeducation in IV-Drug abuser for reducing high-risk behavior

Official Title
-----------------
The Effectiveness of Skill-Based HIV Psychoeducation in IV-Drug Abuser for Reducing High-risk Behavior

Conditions
-----------------
Addiction, Risk Reduction Behaviour

Intervention / Treatment
-----------------
* Behavioral: Psychoeducation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age more than 18 years old Dependency to opioid drugs (Positive result of Urin addiction test) Exclusion Criteria: suicide attempt not tendency for including to the study receiving treatment for addiction in recent months.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Psychoeducation<br>Psycheducation | Behavioral: Psychoeducation<br> <br> |
| No Intervention: Control<br>The control group will not take any intervention | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IV usage of opioid | The number of usage by interview | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usage of condom and safety syringe | the number of usage by interview | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Addiction, Psychoeducation, Risk reduction behaviour, Drop in center (DIC)
Audiological Disturbances in Vitiligo

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine wether vitiligo patients have more audiological abmnormalities, than the healthy population.

Conditions
-----------------
Vitiligo, Hearing Loss

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: vitligo patients under 50. healthy patients under 50 for control group Exclusion Criteria: above age 50. systemic disease. exposure to loud noise in past. familial history of deafness use of autotoxuc drugs or steroids. autoimmune/metabolic/neurologic/vascular disease

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 50 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A Study to Assess the Efficacy, Safety and Tolerability of Tegaserod Alone and in Combination With Omeprazole Given Orally in Patients With Symptoms of Symptomatic Gastroesophageal Reflux Disease (sGERD)

Study Overview
=================
Brief Summary
-----------------
Gastroesophageal Reflux Disease (GERD) is a common disorder caused by the reflux of gastric (stomach) acid into the esophagus. The exposure of the lining of the esophagus to the acid will cause damage to the esophagus over time. The symptoms of GERD include heartburn and acid regurgitation This study will determine if Tegaserod alone and in combination with omeprazole is safe and relieves the symptoms of heartburn.

Official Title
-----------------
A Study to Assess the Efficacy, Safety and Tolerability of Tegaserod Alone and in Combination With Omeprazole Given Orally in Patients With Symptoms of Symptomatic Gastroesophageal Reflux Disease (sGERD)

Conditions
-----------------
Symptomatic Gastroespohageal Reflux Disease

Intervention / Treatment
-----------------
* Drug: Tegaserod


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of physician diagnosed GERD Heartburn and Regurgitation 3 Days during the week prior to screening Exclusion Criteria: History of erosive esophagitis, Barrett's esophagus, esophageal stricture, scleroderma, Zollinger-Ellison Syndrome, known primary disorder History or presence of infection or inflammation of the small or large intestine, gastrointestinal malignancy, history of upper GI surgery Use of PPI during the last four weeks prior to screening Other protocol-defined inclusion/exclusion criteria may apply.

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

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

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: Tegaserod|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients experiencing resolution of heart-burn during week 4 of treatment |  |  | 
| Proportion of patients experiencing resolution of heart-burn during week 4 of treatment in combination with Omeprazole and compared with Omeprazole alone |  |  | 
| Decreasing frequency of regurgitation during week 4 of treatment |  |  | 
| Decreasing frequency of regurgitation during week 4 of treatment in combination with Omeprazole and compared with Omeprazole alone |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GERD, heartburn, regurgitation, reflux disease