linjc16/ctgov huggingface dataset:
Factors Influencing Response to One BoNT-A Injection Cycle in Subjects Suffering From Idiopathic Cervical Dystonia

Study Overview
=================
Brief Summary
-----------------
A post marketing, international, multicenter, observational, prospective, longitudinal study. The purpose of the study is to describe cervical dystonia sub-types with their injection protocols and response to BoNT-A.

Official Title
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An International, Observational Study to Define Factors Influencing Response to One BoNT-A Injection Cycle in Subjects Suffering From Idiopathic Cervical Dystonia

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Idiopathic cervical dystonia TWSTRS severity score ≥ 15 At least a 12-week interval between the last injection (BoNT-A or BoNTB) and inclusion Written informed consent prior to collect the data Exclusion Criteria: Contraindications to any BoNT-A preparations Secondary cervical dystonia Subject already been included in the study

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 |
| --- | --- | --- |
| Responder rate at peak effect following one BoNT-A injection cycle without any deviations from routine practice |  | Around 4 weeks post injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To describe TWSTRS change scores from inclusion (total score & subscales scores) |  | Baseline, and around 4 weeks and 3 months post injection | 
| To describe tremor change score from inclusion (TSUI scale) |  | Baseline, and around 4 weeks and 3 months post injection | 
| To describe the Cervical Dystonia Impact Profile (CDIP) 58 change from inclusion |  | Baseline, and around 4 weeks post injection | 
| To describe subject and investigator's CGI scores |  | Around 4 weeks post injection | 
| To identify prognostic factors for response (Exploratory Objective) |  | baseline, and around 4 weeks and 3 months post injection |
Perioperative Pregabalin and Continuous Wound Infusion for Pain Control Following Thoracotomy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the efficacy of pregabalin or pregabalin and continuous wound infusion versus placebo for analgesia following thoracotomy

Conditions
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Post-thoracotomy Pain

Intervention / Treatment
-----------------
* Drug: Pregabalin and normal saline infusion, PRG
* Drug: Pregabalin and ropivacaine 02% infusion
* Drug: Placebo drug, normal saline infusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients scheduled for a thoracotomy, Exclusion Criteria: age >70 years BMI > 30 preoperative Hb < 10 mg/dL preexistent chronic pain neurologic disease chronic assumption of alcohol treatment with analgesics, anxiolytics, sedatives, antidepressants, or calcium channel inhibitors

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: pregabalin<br>perioperative pregabalin starting the evening before surgery, and for five days postoperatively | Drug: Pregabalin and normal saline infusion, PRG<br> <br> |
| Active Comparator: pregabalin and continuous wound infusion<br>Pregabalin as previous group and continuous infusion of ropivacaine 0.2% via a wound catheter | Drug: Pregabalin and ropivacaine 02% infusion<br> <br> |
| Placebo Comparator: placebo<br>Placebo drug and normal saline infusion | Drug: Placebo drug, normal saline infusion<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain control |  | 5 days postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| morphine consumption |  | 3 days postoperatively |
Feasibility Evaluation of OtoSet

Study Overview
=================
Brief Summary
-----------------
This is a single center study. 100 ears are planned (up to 100 patients). Each subject will have one or both ears cleaned with OtoSet. The subject's level of earwax will be evaluated before and after by an evaluator.

Detailed Description
-----------------
This is a single center study. 100 ears are planned (up to 100 patients). Each subject will have one or both ears cleaned with OtoSet. The subject's level of earwax will be evaluated before and after by an evaluator. Screening data will be reviewed to determine subject eligibility. Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study. Total duration of subject participation will be 1 day with a follow up call within 2-4 days after the procedure. Total duration of the study is expected to be 3 months.

Official Title
-----------------
Feasibility Evaluation of the OtoSet - Ear Cleaning System

Conditions
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Cerumen Impaction of Both Ears

Intervention / Treatment
-----------------
* Device: OtoSet - Ear Cleaning System


Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: Mild (1), Moderate (2), or Complete (3) occlusion of the ear canal based on the Degree of Occlusion Scale in one or both ears Informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study Exclusion Criteria: Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient of the quality of data Subject has life threatening illness Subject has immune deficiency

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OtoSet - Ear Cleaning Sytem<br> | Device: OtoSet - Ear Cleaning System<br>* Up to five (5) cleaning cycles using the OtoSet - Ear Cleaning System<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy as Assessed by Occlusion Scale | Improvement of 1.0 on the Degree of Occlusion Scale (4 point scale) pre- and post-procedure evaluation (score 0 = no occlusion; 3 = complete occlusion) | Treatment Visit (Day 1) (pre- to post-procedure) | 
| Safety as Assessed by Adverse Events | Incidence of adverse events with severity defined using the National Cancer Institute's Common Terminology Criteria for Adverse Events (4 point scale) (1 = mild; 4 = life-threatening) | Treatment Visit (Day 1) through follow-up call (Day 2-4) |
An Audit on Management of Chronic Diarrhea

Study Overview
=================
Brief Summary
-----------------
The study is to assess whether the staff in gastroenterology unit are sticking to the agreed up on unit's protocol in management of chronic diarrhea over the period of one year(september 2017-september 2018)

Detailed Description
-----------------
chronic diarrhea is defined as having loose or watery stools more than three times aday.Awakening at night to pass stools us often sign of an organic cause of diarrhea.In some cases chronic diarrhea is the result of intestinal infection that persists longer than expected. In other cases chronic diarrhea is apart of a systemic illness. Etiology: post enteritis diarrhea syndrome in whic small intestinal mucosal damage persists after acute gastroenteritis.Also secondary disaccharidase deficiency and reinfection may be a cause. infectious causes:enteric infection is an important cause.Associated conditions may be T.B or impaired immunity as in malnutrition potentiating the likely-hood of prolonging or acquiring another infection.Viral infection like Rota virus,parasites as E.coli,Giardia lamblia as well as amebiasis have been implicated in chronic diarrhea. Cytomegalovirus on the other hand may act as an opportunistic agent in immuno compromised patients. Non infectious causes include cow's milk allergy,lactose intolerance and inflammatory bowel disease,all of which may cause chronic diarrhea that is often associated with abdominal pain with or without elevated levels of inflammatory markers. Malabsorption syndrome e.g Celiac disease,cystic fibrosis where the stools are usually fatty in nature and bulky in amount. Good management of chronic diarrhea must include investigations and treatment.A protocol must be followed accurately therefore. Methodology: measurment of the degree of sticking of staff in Gastro-enterology unit to the agreed upon unit's protocol in management of chronic diarrhea over the period of one year (September 2017-September 2018).

Official Title
-----------------
An Audit on Management of Chronic Diarrhea

Conditions
-----------------
Chronic Diarrhea

Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: age group from 2 months to 18 years cases with diarrhea lasts 2 weeks or more Genetically free Exclusion Criteria: age group from 0-2 months age group above 18 years cases with diarrhea less than 2 weeks Gentic disease

Ages Eligible for Study
-----------------
Minimum Age: 2 Months
Maximum 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 |
| --- | --- | --- |
| proper management of chronic diarrhea | start accurate treatment of chronic diarrhea by reaching a definitive cause of each case . decrease the incidence of undiagnosed cases of chronic diarrhea | september 2017-september 2018 |
Cell Therapy With Bone Marrow Mononuclear Cells in Critical Leg Ischemia (CLI)

Study Overview
=================
Brief Summary
-----------------
This study will treat by cell therapy 20 patients with critical leg ischemia (CLI) not eligible for revascularization or angioplasty. It will use exactly the same protocol as published by Tateishi-Yuyama et al. (Lancet 2002), using bone-marrow mononuclear cells (BMMNC).

Detailed Description
-----------------
Patients will be included with CLI according to the TASC criteria. Under general anesthesia, 500 ml of bone marrow is harvested in both iliac crests. After isolation and concentration of the BMMNC in 30 ml, 40 injections of around 0.75 ml will be done in the gastrocnemius of the ischemic leg, within 3 hours after preparation of the cell therapy product. Patients will then be followed-up every week during one month and then every month during one year. This study was approved by the ethical committee of Paris-Broussais HEGP (France) and our french regulatory agency (AFSSAPS). It began including patients in January 2005 and will last until December 2007.

Official Title
-----------------
Optimisation d'un Produit de thérapie Cellulaire Autologue Par Cellules mononucléées médullaires Dans l'ischémie Critique Des Membres inférieurs liée à l'athérosclérose

Conditions
-----------------
Critical Leg Ischemia

Intervention / Treatment
-----------------
* Procedure: cell therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 Signature of informed consent Critical leg ischemia with ankle pressure < 70 mmHg Ischemic ulcer or gangrene No possibility of surgical revascularization No possibility of angioplasty Exclusion Criteria: Cancer Suspicion of a cancer on X-Ray, mammography or elevated PSA Age < 18 Life expectancy < 6 months Active retinopathy Angioplasty or surgical revascularization within 3 months Stoke within 3 months HIV + or HCV/HBC+

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 |
| --- |
|Procedure: cell therapy|Injection of Bone-Marrow mononuclear cells in the muscles of the calf.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ankle brachial index |  | 6 months | 
| Healing |  | 1 year | 
| Amputation rate |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TcPO2 |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PAD, critical leg ischemia, cell therapy
Japan Post Marketing Surveillance of the GORE® CARDIOFORM Septal Occluder

Study Overview
=================
Brief Summary
-----------------
The purpose of this post-marketing surveillance is to evaluate the effectiveness and safety of GORE® CARDIOFORM Septal Occluder under the post-marketing setting in Japan.

Official Title
-----------------
Post Marketing Surveillance of the GORE® CARDIOFORM Septal Occluder

Conditions
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Stroke, PFO - Patent Foramen Ovale, Cryptogenic Stroke, TIA

Intervention / Treatment
-----------------
* Device: GORE® CARDIOFORM Septal Occluder


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with cryptogenic stroke (including transient ischemic attack with positive head imaging findings) Diagnosed with a PFO Note: Additional Inclusion Criteria may apply Exclusion Criteria: N/A

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

| Intervention/Treatment |
| --- |
|Device: GORE® CARDIOFORM Septal Occluder|Patients for whom the device is used (implanted or used by not implanted) during the enrollment period of this post-marketing surveillance will be considered eligible for the study|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFO Closure Rate | PFO closure success will be defined as the number of cases which achieve effective PFO closure at 12 months post-initial procedure out of those which complete the PFO closure evaluation under Trans-Thoracic Echocardiography (TTE) with bubbles. PFO effective closure will be defined as the number of bubbles confirmed to be less than 20 (<20). | 12 months | 
| Rate of Conversion to surgical procedure | Rate of post-procedure conversion to surgical procedure will be calculated. | Discharge | 
| Incidence rate of post-procedure ischemic stroke events | Incidence rate of post-procedure ischemic stroke will be calculated. Additionally, those stroke events will be evaluated by Kapan-Meier plot. | 36 months | 
| Device success | Device success will be calculated by the number of cases with successful device implant during the initial procedure and later follow-ups out of those which underwent the transcatheter PFO closure procedure. | 36 months | 
| Incidence rate of post-procedure adverse events and/or device issues | Incidence rate of adverse events and/or device issues collected through each follow-up period will be calculated. | 36 months | 
| Incidence rate of device- and procedure-related events within 30 days post procedure | Incidence rate of adverse events and/or device issues which are defined as device- or procedure-related within 30 days post procedure will be calculated. | 30 days |
Cellulose Sulfate and HIV Transmission Among Women

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine the effect of cellulose sulfate on the transmission of HIV to women via vaginal intercourse. The secondary objectives are the effect on the transmission of gonorrhea and chlamydia via the same route. The study hypothesis is that there will be no effect.

Detailed Description
-----------------
Despite the availability of an effective HIV prevention method, i.e. the condom, the epidemic continues growing. There is thus an urgent need for additional HIV prevention methods. One of the possibilities is the use of microbicides, i.e. chemical products which may be used in the vagina or rectum with the potential to prevent HIV infection. Cellulose sulfate is an HIV entry inhibitor with an in vitro effect on N. gonorrhoeae (NG) and C. trachomatis (CT) and other sexually transmitted organisms. The study assess its effect on the vaginal transmission of HIV, NG and CT among women at high risk of heterosexual STI infection (defined as having had more than two partners in the last three months and an average of three sexual acts per week). The study is randomized, triple-blinded, placebo controlled.

Official Title
-----------------
Randomized Controlled Trial of 6% Cellulose Sulfate Gel and the Effect on Vaginal HIV Transmission

Conditions
-----------------
HIV Infection

Intervention / Treatment
-----------------
* Drug: Cellulose Sulfate gel (6%)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: at least 18 years old an average of at least three vaginal sex acts per week, at least three different partners in the last three months, expecting to continue this behavior HIV negative willing and able to comply with the protocol Exclusion Criteria: pregnancy allergy to latex or spermicides intravenous drug user

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Cellulose Sulfate gel (6%)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combined incidence of HIV-1 and HIV-2 in the study. |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time-to-first incidental gonococcal or chlamydial infection. |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV prevention, Randomized controlled trial, Women, Sexually transmitted infections, HIV Seronegativity
Molecular Diagnostic Methods for Detection of Plasmodium Knowlesi

Study Overview
=================
Brief Summary
-----------------
This study aims to determine the sensitivity, specificity, and practical value of two new molecular diagnostic assays compared to a more classical nested molecular diagnostic assay and the routine microscopy (both of which are the current gold standard) in detection of P. knowlesi.

Official Title
-----------------
Adapting Novel Molecular Diagnostic Methods for Detection of Plasmodium Knowlesi in Sarawak, Malaysia

Conditions
-----------------
Plasmodium Knowlesi Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Suspected for malaria infection; fever (axillary or tympanic temperature ≥ 37.5 °C or oral or rectal temperature of ≥ 38 °C) with chills, worsening malaise, headache lassitude, fatigue, abdominal discomfort, muscle and joint aches, anorexia, perspiration, or vomiting at the time of evaluation or within the past 48 hours Written informed consent is obtained. For Children (>7 to <18 years): parent or legal guardian provides written informed consent. Exclusion Criteria: Patients living in, or returning from malaria endemic area outside of Sarawak within 2 weeks of illness onset They have a clear alternative diagnosis other than malaria by a trained health care professional.

Ages Eligible for Study
-----------------
Minimum Age: 7 Years

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with a possible diagnosis of malaria | Possible diagnosis of malaria as defined in accordance with the inclusion and exclusion criteria. Giemsa-stained thick and thin smears will be prepared for verification of parasitaemia by microscopy in the respective hospital laboratories | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Statistical association between risk factors and diagnostic assays results. | A brief enrollment questionnaire will be used to determine a statistical association between demographic and behavioral/occupational risk factors and the assays results combined | 10 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Monkey malaria