linjc16/ctgov huggingface dataset:
Lipid Encapsulation for Ileal Brake Activation

Study Overview
=================
Brief Summary
-----------------
This study evaluates the ability of encapsulation of orally applied lipids in a yoghurt snack to modify ad libitum food intake and satiety, without GI symptoms. Every subject receives two treatments (active, and placebo) on two different days, following a randomized cross-over design.

Official Title
-----------------
The Effect of Orally Applied Encapsulated Lipids in Yoghurt on Satiety and Food Intake: a Randomized Single-blind Placebo-controlled Study With Cross-over Design

Conditions
-----------------
Appetite Regulation

Intervention / Treatment
-----------------
* Dietary Supplement: Active yoghurt
* Dietary Supplement: Placebo yoghurt


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI between 25-30 kg/m2 Voluntary participation Exclusion Criteria: Milk (-protein or lactose)- allergy/intolerance History of serious GI complaints/surgeries Pregnancy, lactation Excessive alcohol consumption (>20 per week) Abnormal eating behaviour Intention to stop smoking Reported unexplained weight loss or gain in the month prior to screening Self-admitted HIV-positive state

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active yoghurt<br>Yoghurt snack containing encapsulated lipid | Dietary Supplement: Active yoghurt<br>* Active yoghurt (containing encapsulated lipid) will be ingested after a standardized breakfast, and subsequently satiety and food intake will be measured.<br>|
| Placebo Comparator: Placebo yoghurt<br>Yoghurt snack containing non-encapsulated lipid + empty encapsulation matrix | Dietary Supplement: Placebo yoghurt<br>* Placebo yoghurt (containing non-encapsulated lipid) will be ingested after a standardized breakfast, and subsequently satiety and food intake will be measured.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ad libitum food intake | t=0: standardized breakfast, t=90 minutes: yoghurt, t=210 minutes: ad libitum food intake | 2 hours after yoghurt snack | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satiety feelings | Every 15-30 min, 5 attributes will be measured on a Visual Analogue Scale | Up to 3.5 hours on each of the 2 test days. | 
| occurrence and severity of GI symptoms | Every 15-30 min, 4 attributes will be measured on a Visual Analogue Scale | Up to 3.5 hours on each of the 2 test days. |
Comparison of Screw and Suture Button Technique Results in Ankle Syndesmosis Injuries

Study Overview
=================
Brief Summary
-----------------
In this study, syndesmosis injuries were detected in 143 of the patients who came to Atatürk University Faculty of Medicine, Orthopedics and Traumatology clinic from October 2017 to October 2021 with ankle fractures. 33 of these patients couldn't followed for various reasons. Screw or suture buttone method was applied on 110 patients. And patients were examined with lots of data to compare their results. A retrospective study was conducted.

Official Title
-----------------
Comparison of Screw and Suture Button Technique Results in Ankle Syndesmosis Injuries

Conditions
-----------------
Ankle Injuries, Syndesmotic Injuries, Tibiofibular; Dislocation Distal

Intervention / Treatment
-----------------
* Device: Screw fixation
* Device: Suture button


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ankle fractures associated with syndesmotic injury Age group 19-91 years Dislocation or non-dislocation ankle fractures Fractures due to acute injury (less than 3 weeks) Patient compliance with follow-up Exclusion Criteria: Patients younger than 18 years of age Conservative treatment Pathological and neglected fractures Patient's non-compliance with follow-up

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 91 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 |
| --- | --- |
| Screw<br>Screw fixation | Device: Screw fixation<br>* Screw fixation to patients<br>|
| Suture button<br>Suture button | Device: Suture button<br>* Suture button for patients<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| angles of the joint range of motion | Calculate joint range of motion by measuring the angles between the beginning position and the ending position of available motion with goniometer | 12 months after surgery |
DP-R212 Pharmacokinetic Study

Study Overview
=================
Brief Summary
-----------------
An open-label, multiple-dose study to evaluate the pharmacokinetic drug-drug interaction of amlodipine and rosuvastatin in healthy adult male subjects.

Conditions
-----------------
Hypertension, Hyperlipidemias

Intervention / Treatment
-----------------
* Drug: Amlodipine
* Drug: Rosuvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI 18-29 signed the informed consent form prior to the study participation Exclusion Criteria: Clinically significant disease Previously donate whole blood within 60 days or component blood within 14 days Clinically significant allergic disease Taken IP in other trial within 90 days An impossible one who participates in clinical trial by investigator's decision including laboratory test result

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: amplodipine group<br>Amlodipine for 8 days and Amlodipine+Rosuvastatin for 5 days | Drug: Amlodipine<br>* Amlodipine administration<br>Drug: Rosuvastatin<br>* Rosuvastatin administration<br>|
| Experimental: rosuvastatin group<br>Rosuvastatin for 5 days and Amlodipine+Rosuvastatin for 8 days | Drug: Amlodipine<br>* Amlodipine administration<br>Drug: Rosuvastatin<br>* Rosuvastatin administration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCτ,ss of Amlodipine and Rosuvastatin |  | 0,0.5,1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 hr | 
| Cmax,ss of Amlodipine and Rosuvastatin |  | 0,0.5,1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 hr |
First in Man Study With SLV341

Study Overview
=================
Brief Summary
-----------------
First in man study with single and multiple rising doses with SLV341

Official Title
-----------------
A Double-blind, Randomized, Placebo-controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SLV341 in Young Healthy Male Subjects

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Drug: SLV341
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria healthy Exclusion Criteria not healthy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: SLV341<br>* 5 - 1000mg once daily<br>|
| Placebo Comparator: B<br> | Drug: placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability parameters: adverse event, vital signs, 12-Lead ECG, continuous lead II ECG monitoring, laboratory safety variables and physical examination. |  | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameters: Plasma: Cmax, tmax, AUC, t½, λz, CL/F, and Vz/F. Urine: Aeurine, fe, and CLR |  | 1 - 28 days | 
| Pharmacodynamic parameters: biochemistry and 24 h Holter monitoring. |  | 28 days | 
| Interaction with Midazolam |  | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
First in Man, SLV341, diabetes
After Surgery Acute Renal Failure Incidence in Total Knee Arthroplasty With and Without Tourniquet

Study Overview
=================
Brief Summary
-----------------
This study analize the incidence of acute renal failure after performing total knee arthroplasty with or without use of tourniquet limb cuff (half of patients for each group) in a randomized clinical trial

Detailed Description
-----------------
This study analize the incidence of acute renal failure after performing total knee arthroplasty with or without (using local intraarticular anesthesia) use of tourniquet limb cuff (half of patients for each group) in a randomized clinical trial

Official Title
-----------------
After Surgery Acute Renal Failure Incidence in Total Knee Arthroplasty With and Without Tourniquet

Conditions
-----------------
Arthroplasty, Replacement, Knee, Acute Kidney Injury, Tourniquets, Knee Osteoarthritis

Intervention / Treatment
-----------------
* Procedure: total knee arthroplasty
* Procedure: Tourniquet limb cuff
* Drug: Intaarticular lidocain


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients knee arthrosis Required a surgical treatment with Total Knee Arthroplasty Exclusion Criteria: Not accept to be in the study Not signed consent form Not having blood sample for creatinin meassure

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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
Interventional Model Description: Randomized Clinical Trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: TKA and Tourniquet<br>Total knee arthroplasty and use of tourniquet limb cuff at 270 mmHg | Procedure: total knee arthroplasty<br>* Total knee arhroplasty<br>* Other names: TKA;Procedure: Tourniquet limb cuff<br>* Tourniquet limb cuff and regular anesthesia<br>|
| Experimental: Intraarticular lidocain<br>Total knee arthroplasty with Intaarticular lidocain | Procedure: total knee arthroplasty<br>* Total knee arhroplasty<br>* Other names: TKA;Drug: Intaarticular lidocain<br>* 20 ml of 2% lidocain application intraarticular before surgery (intraarticular lidocain)<br>* Other names: lidocaine;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Creatinin before surgery | Blood Creatinin meassure in mg/dl before surgery | Creatinin before surgery | 
| Creatinin after surgery 1 | Blood Creatinin meassure in mg/dl at 24 hours | Creatinin after surgery 1 at 24 hours | 
| Creatinin after surgery 2 | Blood Creatinin meassure in mg/dl at 48 hours | Creatinin after surgery 2 at 48 hours |
A Study to Evaluate the Effect of MK0966 (Rofecoxib) on the Recurrence of Colorectal Adenomas (0966-122)

Study Overview
=================
Brief Summary
-----------------
This study was to compare the effect of 156 weeks of treatment with MK-0966 (Rofecoxib) versus placebo on the recurrence of colorectal adenomas (growths that occur on the inside (the lining) of the large intestine, also known as the colon) in patients with a history of colorectal adenomas.

Official Title
-----------------
A Multicenter, Randomized, Parallel-Group, Placebo-Controlled, Double-Blind Study With In-House Blinding to Determine the Effect of 156 Weeks of Treatment With MK0966 on the Recurrence of Neoplastic Polyps of the Large Bowel in Patients With a History of Colorectal Adenomas

Conditions
-----------------
Colorectal Adenoma

Intervention / Treatment
-----------------
* Drug: MK0966; Rofecoxib / Duration of Treatment: 156 weeks
* Drug: Placebo/ Duration of Treatment: 156 weeks


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eligible patients must have undergone a complete colonoscopy within 12 weeks of study entry with removal of all polyps; at least one polyp must have been confirmed a large bowel pre-cancerous polyp (adenoma) by the study pathologist. Exclusion Criteria: History with a specific hereditary large bowel polyp syndrome History of a large bowel adenoma before age 35 Small or large bowel resection or history of inflammatory bowel disease History of cancer within the five years before enrollment Expected need for chronic NSAID therapy Positive test result for stool occult blood Uncontrolled hypertension, stroke or temporary mini stroke (TIA) within the past 2 years, angina or congestive heart failure with symptoms that occur at rest or with minimal activity History of myocardial infarction (heart attack), coronary angioplasty, or coronary artery bypass grafting within the past 1 year Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

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

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

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: MK0966; Rofecoxib / Duration of Treatment: 156 weeks|nan|
|Drug: Placebo/ Duration of Treatment: 156 weeks|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative colorectal adenoma recurrence during treatment in patients with an increased risk to develop colorectal cancer. |  | 156 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative colorectal adenoma recurrence during treatment in patients with a history of colorectal adenoma |  | 156 Weeks | 
| Cumulative colorectal adenoma recurrence during treatment in all patients |  | 52 Weeks | 
| To evaluate safety & tolerability of rofecoxib |  |  |
Keyhole Limpet Hemocyanin in Chronic Hepatitis C

Study Overview
=================
Brief Summary
-----------------
In this study the investigators examine the safety and efficacy of Keyhole-limpet-hemocyanin in patients with chronic hepatitis c infection and liver cirrhosis. The investigators hypothesize that administration of keyhole-limpet-hemocyanin reduces the viral load in patients infected with hepatitis c.

Official Title
-----------------
Keyhole Limpet Hemocyanin in Chronic Hepatitis C and Compensated Cirrhosis - Pilot Study IM1

Conditions
-----------------
Chronic Hepatitis C, Liver Cirrhosis

Intervention / Treatment
-----------------
* Drug: keyhole-limpet hemocyanin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic Hepatitis C infection no previous therapy at least one contraindication to interferon therapy liver cirrhosis age between 18-80 y women of not childbearing age Exclusion Criteria: Hypersensitivity against keyhole-limpet hemocyanin previous treatment against hepatitis c autoimmune disorders immunosuppression hepatocellular carcinoma or other malignancies coinfection with hepatitis b or HIV pregnancy cardiovascular event during the last 6 months (stroke or MCI) uncontrolled diabetes renal insufficiency (GFR < 50 ml/min) or chronic hemodialysis

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Keyhole-limpet hemocyanine<br> | Drug: keyhole-limpet hemocyanin<br>* Subcutaneous administration keyhole-limpet hemocyanin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hepatitis C viral load at week 24 |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hepatitis c viral load at weeks 1,2,4,8,12,18,32 |  | 1,2,4,8,12,18,32 weeks |
HOPE (Harnessing Online Peer Education): Using Online Social Networks for HIV Prevention and Testing

Study Overview
=================
Brief Summary
-----------------
This study seeks to determine whether social networking technologies can be used to increase HIV prevention and testing.The HOPE (Harnessing Online Peer Education) model seeks to apply a diffusion of innovations style intervention to social media to increase HIV testing.

Official Title
-----------------
Using Online Social Networks for HIV Prevention and Testing

Conditions
-----------------
HIV

Intervention / Treatment
-----------------
* Behavioral: HIV knowledge Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older Has had sex with a man in the past 12 months Lives in Lima or Callao, Peu Has a Facebook account or willing to create one Exclusion Criteria: Does not satisfy inclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HIV intervention Group<br>Experimental arm receives peer-led HIV information on social media | Behavioral: HIV knowledge Intervention<br> <br> |
| No Intervention: Control arm<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIV self-testing-Number of participants who request an HIV self-testing kit |  | Measured during the intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, social networking, at-risk populations, sexual risk behaviors
Phase II Study of Carmustine, Streptozocin, and Mercaptopurine for Refractory or Recurrent Brain Neoplasms

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Assess the clinical response of patients with refractory or recurrent brain neoplasms treated with carmustine, streptozocin, and mercaptopurine.

Detailed Description
-----------------
PROTOCOL OUTLINE: Patients receive mercaptopurine IV on days 1-3, carmustine by continuous infusion on days 3-5, and streptozocin IV over 20 minutes on days 2-5. Patients receive treatment every 42 days, for up to 4 courses. Completion date provided represents the completion date of the grant per OOPD records

Conditions
-----------------
Anaplastic Astrocytoma, Anaplastic Oligodendroglioma, Mixed Gliomas, Glioblastoma Multiforme, Recurrent Brain Tumor

Intervention / Treatment
-----------------
* Drug: carmustine
* Drug: mercaptopurine
* Drug: streptozocin


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Histologically proven refractory or recurrent brain neoplasms Glioblastoma multiforme Anaplastic astrocytoma Gliosarcoma Anaplastic oligodendroglioma Mixed anaplastic glioma Unequivocally progressive primary brainstem tumors following primary therapy Measurable disease --Prior/Concurrent Therapy-- Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy At least 6 weeks since prior nitrosoureas or mitomycin Endocrine therapy: Not specified Radiotherapy: Prior radiotherapy allowed Surgery: Prior surgery allowed --Patient Characteristics-- Age: Not specified Performance status: ECOG 0-2 Karnofsky 60-100% Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT no greater than 4 times normal Renal: Creatinine no greater than 2.0 mg/dL Pulmonary: FEV1 greater than 1 L if symptomatic pulmonary disease present Other: No other concurrent malignancies Not pregnant or lactating Negative pregnancy test Fertile patients must use effective contraception
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: carmustine|nan|
|Drug: mercaptopurine|nan|
|Drug: streptozocin|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
-----------------
adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult brain stem glioma, adult brain tumor, adult glioblastoma multiforme, adult infiltrating astrocytoma, brain tumor, genetic condition, miscellaneous sites/terms, mixed gliomas, nervous tissue tumors, oncologic disorders, rare disease, recurrent adult brain tumor