linjc16/ctgov huggingface dataset:
The Safety and Effectiveness of 524W91

Study Overview
=================
Brief Summary
-----------------
To assess the safety and pharmacokinetics of single oral doses of 524W91 administered in HIV-infected patients. To determine the effects of food on bioavailability of 524W91.

Detailed Description
-----------------
Patients are randomized to receive six single escalating doses of 524W91 or placebo, with each dose separated by at least a 6-day washout interval. In the time between 2 of the doses, the effect of food on pharmacokinetics will be investigated, with one dose administered in conjunction with a high-fat meal and one dose administered in a fasted state.

Official Title
-----------------
A Phase I, Randomized, Single-Dose, Placebo-Controlled Trial to Evaluate the Safety and Pharmacokinetics of 524W91

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Emtricitabine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must have: Documented HIV infection. CD4 count >= 200 cells/mm3. No active opportunistic infection. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Malignancy or other condition that would confound study assessment or interfere with ability to complete the study. Malabsorption syndrome or other gastrointestinal dysfunction that might interfere with gastrointestinal absorption. Concurrent Medication: Excluded on the day of each dose: Antiretrovirals. Any prescription or over-the-counter medication. Alcoholic beverages. Coffee, tea, and other xanthine-containing beverages and foods. Patients with the following prior conditions are excluded: History of hepatitis, pancreatitis, or cardiomyopathy within the past 5 years. Prior Medication: Excluded: Antiretrovirals within 24 hours prior to each dose. Any prescription or over-the-counter medications within 48 hours prior to each dose. Alcoholic beverages within 48 hours prior to each dose. Current alcohol or illicit drug use that may affect patient compliance.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Emtricitabine|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
-----------------
Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents
Relationship Between Pressure and Flow Velocity on Coronary Physiology

Study Overview
=================
Brief Summary
-----------------
Subjects are patients who are planned to do percutaneous coronary intervention for coronary stenosis in the left circumflex artery without other stenosis in the left ascending artery and the right coronary artery, or a patient with normal coronary artery. Immediately after coronary angiography or percutaneous coronary intervention, the investigators will evaluate for coronary hemodynamics by distribution of wave intensity which is calcurated by coronary pressure and flow velocity with Combowire in each coronary segment. Also, they will assess coronary morphology by View It in each coronary segment.

Detailed Description
-----------------
Combowire (Volcano Therapeutics Inc., CA, USA) is a 0.014 inch pressure/Doppler sensor-tipped-guidewire which can measure coronary pressure and flow velocity. View It (Terumo Co., Japan) is a guide catheter with intravascular ultrasound which can measure coronary morphology such as vessel diamter.

Official Title
-----------------
Relationship Between Pressure and Flow Velocity on Coronary Physiology

Conditions
-----------------
Coronary Stenosis

Intervention / Treatment
-----------------
* Device: combowire and IVUS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A patient who are planned to do percutaneous coronary intervention for stenosis in the left circumflex artery without any lesions in other coronary arteries Or a patient who is performed coronary angiography without significant stenosis lesion in 3-coronary vessel Exclusion Criteria: A patient with coronary stenosis with LAD Hemodialysis Acute coronary syndrome Congestive heart failure A patient with shock vitals

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Normal coronary artery<br> | Device: combowire and IVUS<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wave intensity |  | Immediately after coronary angiography or percutaneous coronary intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coronary pressure |  | Immediately after coronary angiography or percutaneous coronary intervention | 
| Flow velocity |  | Immediately after coronary angiography or percutaneous coronary intervention | 
| Vessel diameter |  | Immediately after coronary angiography or percutaneous coronary intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coronary Circulation
Dilators for Dyspareunia Prevention

Study Overview
=================
Brief Summary
-----------------
This is a randomized clinical trial comparing rates of de novo dyspareunia in women with and without vaginal dilator use following surgery for pelvic organ prolapse with traditional posterior repair. Our hypothesis is daily use of vaginal dilators from post-op week 4 through week 8 after posterior repair will reduce the rate of de novo dyspareunia.

Official Title
-----------------
Vaginal Dilators for Prevention of De Novo Dyspareunia After Prolapse Surgery: A Randomized Controlled Trial

Conditions
-----------------
Post-operative Dyspareunia

Intervention / Treatment
-----------------
* Behavioral: Dilator use


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women who undergo pelvic organ prolapse surgery with a posterior repair Age ≥18 years Sexually active with heterosexual vaginal intercourse English speaking Available for 6 month follow up Able to complete study questionnaires Able to use dilators Exclusion Criteria: Significant baseline dyspareunia Pregnancy by self-report or positive pregnancy test Prior pelvic radiation therapy Active pelvic infection, herpes, candidiasis

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

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No dilator use<br> | |
| Active Comparator: Dilator use<br>Women randomized to vaginal dilators will be given instructions to perform softening exercises from postoperative weeks 4 to 8 | Behavioral: Dilator use<br>* Women randomized to vaginal dilators will be given instructions to perform exercises with vaginal dilators from postoperative weeks 4 to 8<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare rates of de novo dyspareunia in women with and without vaginal dilator use following surgery for pelvic organ prolapse with posterior repair (colporrhaphy). |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sexual function | Change in sexual function after vaginal reconstructive surgery with or without vaginal dilator use as assessed by FSFI and PISQ-12 | 6 month | 
| Physical exam | Change in vaginal caliber and POP Q measurements 3 and 6 months after vaginal reconstructive surgery and its relation to sexual function scores and rates of dyspareunia. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prolapse, Pain with intercourse, Dyspareunia, Post operative pain
The Efficacy of Midazolam & Ketamine Versus Midazolam & Fentanyl for Sedation in Ambulatory Colonoscopies

Study Overview
=================
Brief Summary
-----------------
Providing adequate sedation and analgesia is an integral part of the practice of colonoscopy procedure. There are various protocols and methods used to prevent discomfort and alleviate pain. Conscious sedation is one of the options recommended by the American Society for Gastrointestinal Endoscopy, although the choice of the exact protocol is left to the physician's discretion. This study will attempt to recommend a preferred protocol based on a double blind randomized prospective method. The efficacy of midazolam and ketamine will be compared to the efficacy of midazolam and fentanyl for sedation in ambulatory colonoscopies. The results will be compiled from objective data and patient and physician interviews.

Conditions
-----------------
Colonoscopy, Conscious Sedation

Intervention / Treatment
-----------------
* Drug: Midazolam, Fentanyl
* Drug: KETAMINE, MIDAZOLAM


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Candidates for elective colonoscopy at the Soroka Medical Center who have signed an informed consent. Exclusion Criteria: Hypersensitivity to benzodiazepines Hypersensitivity to benzyl alcohol Hypersensitivity to ketamine Hypersensitivity to opiates Pregnancy Uncontrolled hypertension Myocardial infarct in the last 6 months CVA Chronic pulmonary disease Renal failure Chronic liver disease (CHILD B or C) Elevated ICP, cerebral hemorrhage or cranial SOL. Hypovolemic shock Glaucoma Mental illness Drug or alcohol addiction

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 0<br>fentanyl | Drug: Midazolam, Fentanyl<br>* fentanyl 0.07 mcg/kg + midazolam 0.05 mg/kg if needed adding midazolam up to a total of 0.1 mg/kg<br>|
| Active Comparator: 1<br>ketamine | Drug: KETAMINE, MIDAZOLAM<br>* Ketamine 0.25 mg/kg + midazolam 0.05 mg/kg if needed adding midazolam up to a total of 0.1 mg/kg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery time |  | 24 hours following colonoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sedative effect |  | 24 hours following colonoscopy | 
| Patient compliance |  | 24 hours following colonoscopy | 
| Side effects |  | 24 hours following colonoscopy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
colonoscopy, conscious sedation, midazolam, ketamine, fentanyl
Ropinirole Controlled Release (CR) as an Adjunctive Agent in the Treatment of Major Depression

Study Overview
=================
Brief Summary
-----------------
This is an 8 week study for patients who are currently taking antidepressant medication but not fully responding. Ropinirole CR would be taken in conjunction with current antidepressant medication. Patients come into the clinic once a week when starting on the medication and then once every other week for the remainder of the 8 weeks.

Detailed Description
-----------------
We hope to learn whether ropinirole CR (controlled release formulation) is safe and effective when taken with an antidepressant to reduce the symptoms of depression. Adults who have a diagnosis of major depression and are currently taking an adequate dose of antidepressant medication will be sought for participation. They will continue to take the antidepressant medication and will receive ropinirole CR, an investigational medication, for eight weeks during which information will be collected about mood and cognitive functioning.

Official Title
-----------------
Ropinirole Controlled Release (CR) as an Adjunctive Agent in the Treatment of Major Depression

Conditions
-----------------
Depressive Disorder, Major

Intervention / Treatment
-----------------
* Drug: Ropinirole CR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 to 65 years old Currently experiencing major depression On at least an adequate dose of fluoxetine, paroxetine, sertraline, citalopram, escitalopram, venlafaxine, bupropion, mirtazapine or duloxetine for at least 6 weeks (monotherapy). Exclusion Criteria:1. Pregnant females or females of child bearing years not using adequate birth control in the opinion of the investigators Known sensitivity to ropinirole Significant medical conditions that would preclude safe participation in the study in the opinion of the investigators. Significant abnormalities observed in screening laboratory evaluation

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ropinirole CR|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HamD |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MADRS |  |  |
Mucin Concentration in Sputum From COPD Patients During a Pulmonary Exacerbation

Study Overview
=================
Brief Summary
-----------------
chronic obstructive pulmonary disease (COPD) is typically associated with mucus hypersecretion in the airways. In health, mucin is the major macromolecular component and is responsible for the protective and clearance properties of the mucus gel. In a recent study the investigators found that mucins are decreased and unstable in the sputum of adult cystic fibrosis (CF) patients. In this study the investigators want to investigate the differences on the mucin quantity and quality of airway secretions during pulmonary exacerbation of patients with COPD.

Detailed Description
-----------------
We hypothesize that during an exacerbation the mucin amount is increasing. The aim of this study is to evaluate the molecular (mucins) and structure properties (mucin-stability) of the airway secretions in COPD related to the severity of the disease. We characterize sputum composition of patients with pulmonary exacerbations. Using gel electrophoresis, with specific antibodies we will analyze MUC5AC and MUC5B mucins. The significance of these studies is that they will give us novel information about the pathogenesis of chronic inflammatory airway diseases, provide tools for assessing the progression of lung disease, and most critically, will identify novel opportunities and targets for therapeutic intervention.

Official Title
-----------------
Molekularbiologische Eigenschaften Des Sputums während Einer Pulmonalen COPD Exacerbation

Conditions
-----------------
COPD

Intervention / Treatment
-----------------
* Other: sputum collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: forced expiratory volume at one second (FEV1) < 80% sputum production clinical likely hood of exacerbation Exclusion Criteria: FEV1 > 80% or < 30% increased systemic inflammation susceptibility of pneumonia need for antibiotic treatment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| COPD exacerbation<br>COPD Stadium 2 and 3 during pulmonary exacerbation sputum collection | Other: sputum collection<br>* collecting of spontaneous sputum from the patient<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mucin concentration | analyzing mucin concentration by western | 2 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mucin stability | analyzing mucin stability at 37C over 24 hours | 2 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lung, airway, pulmonary exacerbation, mucus
Single Dose Study With 4SC-203 in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate safety and tolerability of 4SC-203 after a single dose administration in healthy volunteers.

Official Title
-----------------
First-in-Man, Randomised, Double-Blind, Placebo-Controlled, Single Dose Escalation Study of the Novel Compound 4SC-203 in Young Healthy Volunteers

Conditions
-----------------
Acute Myeloid Leukemia

Intervention / Treatment
-----------------
* Drug: 4SC-203
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male subjects aged 18 to 45 years (included), and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening Subjects must be able to communicate well with the investigator, to understand and comply with the requirements of the study, and to understand and sign the written informed consent Exclusion Criteria: Evidence of current or previous clinically significant disease, medical condition or finding of the medical examination (including vital signs and ECG), that in the opinion of the investigator would compromise the safety of the subject or the quality of the data Current or recent history of significant renal, hepatic, haematological, immunological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease which would interfere with the subject's participation in the trial

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

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 4SC-203<br> | Drug: 4SC-203<br>* i.v. administration<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* i.v. administration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigation of safety and tolerability of escalating single doses of 4SC-203. |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the pharmacokinetics of single doses of 4SC-203. |  | 14 days | 
| To assess the pharmacodynamic effect by means of appropriate biomarkers. |  | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
4SC-203, Phase I, single dose, healthy volunteers
Role of Octreotide in Preventing Pancreatic Fistula After Pancreaticoduodenectomy (PD) in Patients With Soft Pancreas

Study Overview
=================
Brief Summary
-----------------
This randomized controlled trial (RCT) aims at assessing the influence of octreotide on pancreatic fistula or complications following pancreatoduodenectomy in patients with soft pancreas. Previously reported trials have included all types of pancreatic resections and have include all types of pancreas and have shown no clearcut benefit of octreotide after pancreaticoduodenectomy (PD). Soft pancreas and normal sized duct are the risk factors for fistula following PD. This study's focus is on this select group of patients and aims to assess the role of octreotide in patients with soft pancreas.

Detailed Description
-----------------
Study design: Prospective open labeled randomized trial. AIM: Study aims at assessing the influence of octreotide on pancreatic fistula or complications following pancreatoduodenectomy in patients with soft pancreas.

Official Title
-----------------
Randomized Controlled Trial on Role of Octreotide in Preventing Pancreatic Fistula and Complications After Pancreaticoduodenectomy in Patients With Soft Pancreas

Conditions
-----------------
Pancreatic Fistula

Intervention / Treatment
-----------------
* Drug: Inj. Octreotide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:elective surgery patients undergoing pancreatoduodenectomy soft pancreas, no dilated duct Exclusion Criteria: age > 75 years old documented chronic pancreatitis previous pancreatic surgery previous gastric surgery vagotomy documented pancreatic duct dilatation

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 75 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: octreotide<br>octreotide arm 100mcg for 5 days. control has no octreotide | Drug: Inj. Octreotide<br>* 100 mcg subcutaneously for 5 days<br>* Other names: Inj Octride;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pancreatic fistula | All grades of postoperative pancreatic fistula as per ISGPF definition | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complications | All outcome measures like oral liquid feeds, semisolid food,hospital stay and complications like bleeding, intra-abdominal collections, respiratory complications, DGE etc are monitored | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
octreotide, pancreatic fistula, soft pancreas, pancreatoduodenectomy