linjc16/ctgov huggingface dataset:
Transcystic Versus Transanastomotic Tube Drainage in Right Lobe LDLT

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety and effectiveness of the use of transcystic biliary drainage tube (not transanastomotic) in comparison to the usual transanastomotic biliary drainage tube.

Detailed Description
-----------------
a biliary drainage tube is usually inserted into the biliary passage after choledocho-choledochostomy (bile duct to bile duct joining). A 4F or 5F biliary catheter (Marquat Genie biomedical, france) is used in all cases. the study is to compare the effectiveness and safety of 2 different placement techniques: the usual trans-anastomotic position (the tube is placed across the anastomosis line with the tip inside the intrahepatic biliary branches) through an opening in the wall of the recipient's common bile duct a transcystic non-anastomotic position (the tube is placed through the cystic duct opening into the distal common bile duct not passing through anastomosis)

Official Title
-----------------
Transcystic Versus Transanastomotic Biliary Drainage Tubes in Living Donor Liver Transplantation. A Prospective Randomized Trial.

Conditions
-----------------
Living Donor Liver Transplantation

Intervention / Treatment
-----------------
* Device: biliary drainage tube


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: living donor liver transplantation single bile duct in the graft Exclusion Criteria: multiple bile ducts

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 70 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Transanastomotic tube<br>use of transanastomotic tube. | Device: biliary drainage tube<br> <br> |
| Active Comparator: Transcystic tube<br>use of transcystic tube to drain bile duct | Device: biliary drainage tube<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| early postoperative biliary fistula |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| biliary stricture |  | 2 years postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
biliary fistula, biliary stricture, biliary drainage tube
Eye Movement Tracking to Detect Impairment Due to Acute Cannabis Intoxication

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the accuracy of an impairment algorithm based on eye tracking while watching a short film clip, in comparison to a clinical reference standard of impairment.

Official Title
-----------------
Eye Movement Tracking to Detect Impairment Due to Acute Cannabis Intoxication

Conditions
-----------------
Impairment, Cannabis Intoxication

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provide written informed consent. Have the ability to provide a complete ophthalmologic, medical and neurologic history as well as report medications/drugs/alcohol consumed within the 24 hours prior to tracking. Be at least 18 years old. Exclusion Criteria: Be blind (no light perception), have missing or non-functional eyes. Be unable to open their eyes. Have a history of unresolved strabismus, diplopia, amblyopia. Have a history of unresolved cranial nerve III, IV, or VI palsy. Have a history of unresolved macular edema, retinal degeneration, extensive cataract, or ocular globe disruption. Have a history of extensive prior eye surgery (examples include strabismus surgery, scleral buckle repair of retinal detachment, repair of blow out fractures of the orbit and any procedures that would interfere with extraocular muscle movements; prior cataract surgery or Lasik are not exclusions) or scarring. Have a prior history of unresolved ocular-motor dysfunctions. Have used cannabis, alcohol etc. 24 hours before study commences. Be 100% naïve to cannabis usage. Be pregnant.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cannabis users<br> | Diagnostic Test: EyeBOX<br>* Eye-Tracking based diagnostic<br>|
| Normals<br> | Diagnostic Test: EyeBOX<br>* Eye-Tracking based diagnostic<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impairment assessment correlation with EyeBOX assessment | A correlation between impairment as assessed by standard impairment tests and the EyeBOX assessment of impairment as determined by an algorithm. | Within an hour |
Preoperative and Postoperative Sublingual Misoprostol for Prevention of Postpartum Blood Loss in Cesarean Section

Study Overview
=================
Brief Summary
-----------------
Cesarean section is one of the most common major surgical operations among women. In 2015, the incidence of cesarean section in Woman Health Hospital in Assiut University accounts for 51.3 % of all deliveries

Official Title
-----------------
Comparison Between Preoperative and Postoperative Sublingual Misoprostol for Prevention of Postpartum Blood Loss in Cesarean Section : a Randomized Clinical Trial

Conditions
-----------------
Postpartum Hemorrhage

Intervention / Treatment
-----------------
* Drug: Misoprostol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All pregnant women who will undergo elective lower segment cesarean section term ( ≥ 37 weeks) normal fetal heart tracing. Exclusion Criteria: Placenta previa-Rupture uterus Classical cesarean section Preterm delivery Hypertensive disorders of pregnancy Bleeding tendency Previous history of postpartum hemorrhage Concurrent anticoagulant therapy Concurrent long-term use of steroids Fetal distress Antepartum haemorrhage
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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: study group<br>will receive sublingual misoprostol immediately after urinary catheterization and before skin incision | Drug: Misoprostol<br>* Oral tablets<br>|
| Active Comparator: control group<br>will receive sublingual misoprostol immediately after skin closure | Drug: Misoprostol<br>* Oral tablets<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean intraoperative blood loss | Blood loss estimation will commence immediately following the skin incision | 24 hours |
A Prospective, Unmasked Evaluation of the iStent in Patients With Primary Open-Angle Glaucoma

Study Overview
=================
Brief Summary
-----------------
Prospective, unmasked, evaluation of the iStent in patients that have primary open-angle glaucoma (OAG). Stent implantation in one eye will be used for analysis, with medication added at 6 months, as required.

Detailed Description
-----------------
One hundred patients will be enrolled in the study at up to 21 sites; follow-up is through 1 year.

Official Title
-----------------
A Prospective, Unmasked Evaluation of the iStent in Patients With Primary Open-Angle Glaucoma

Conditions
-----------------
Glaucoma, Eye Diseases, Glaucoma, Open-Angle

Intervention / Treatment
-----------------
* Device: iStent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of primary open-angle glaucoma Male or female at least 18 years of age and able to provide written informed consent Mean IOP (at baseline visit after washout of any medications) must be at least 22 mm Hg and no greater than 38 mm Hg Likely to be available and willing to attend follow-up visits Exclusion Criteria: Angle closure glaucoma Secondary glaucomas Prior glaucoma procedures Elevated episcleral venous pressure from history of active thyroid orbitopathy, carotid-cavernous fistula, orbital tumors, or orbital congestive disease

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: iStent<br> | Device: iStent<br>* Glaukos iStent, medication<br>* Other names: stent, trabecular micro-bypass stent;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IOP 18 mm Hg or less without medications |  | At 6 months | 
| IOP 18 mm Hg or less with or without medications |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean IOP |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
primary open angle glaucoma (POAG), OAG, glaucoma
A Comparison of Colonic Bile Acid Content Following Right and Left Colectomies

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate whether there is a difference in the bile acid content in the bowel in patients after right versus left colectomy. There is compelling evidence that patients under going resection of the right colon versus left coolon have a lower polyp detection rate in surveillance colonoscopies. The investigators intend to evaluate feces of patients undergoing left and right colectomies; prior to their surgery and again three and six months aftet the surgery. The investigators plan to compare the content of the different bile acids and to compare the content between the two groups.

Official Title
-----------------
A Comparison of Colonic Bile Acid Content Following Right and Left Colectomies

Conditions
-----------------
Colectomy, Bile Acid and Salts

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age above 18. Patients intended to undergo a colectomy for colonic cancer Patients willing and participate and able to sign an informed consent Exclusion Criteria: Age under 18. Patients with Inflammatory Bowel Disease (Crohn's, Ulcerative colitis). Patients refusing to participate or are unable to understand or sign an informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Colonic bile acid content |  | two years |
Naltrexone Treatment for Alcoholism

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the effectiveness of the medication naltrexone (Revia) for treating alcoholism. Individuals will be inpatients for a 2 week period and provide assessments of their alcohol withdrawal symptoms, craving, and mood. Following hospital discharge, individuals will be assigned randomly to receive naltrexone daily, naltrexone twice a day or a placebo. This part of the study will last 12 weeks, with regular measurements of drinking level, craving and mood. Assessments will be conducted 6 and 12 months after the beginning of the study.

Official Title
-----------------
Naltrexone Treatment for Alcoholism: Predicting Outcome

Conditions
-----------------
Alcoholism

Intervention / Treatment
-----------------
* Drug: naltrexone (Revia)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meets criteria for alcohol dependence. Committed to alcohol abstinence as a treatment goal. Individuals will be required to identify two family members or close friends who are knowledgeable about their location, drinking behavior, and psychosocial status. Exclusion Criteria: Meets criteria for any other psychoactive substance use disorder (excluding nicotine and caffeine). Meets criteria for a major psychiatric disorder and are in need of or currently undergoing pharmacotherapy. Females who are pregnant, lactating, or not using a reliable method of contraception. Currently experiencing a serious medical condition that would place them at risk or interfere with study participation. Experiencing acute hepatitis or liver failure or whose liver function test is more than 3 times normal. Have a history of severe allergies, multiple adverse drug reactions or known allergy to naltrexone. Vocabulary below the 5th grade reading level. Abnormal MRI scan. HIV infection due to the neurological sequelae. Significant central nervous system diseases. Seizure disorder or history of closed head trauma. Neuroendocrine disorders. Treatment with opiates within the last six months.

Ages Eligible for Study
-----------------
Minimum Age: 30 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
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: naltrexone (Revia)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
The Role of Genetic Factors in the Development of Idiopathic Osteoarthritis of the Knee in the Kazakh Population

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to identify genetic determinants of susceptibility to idiopathic osteoarthritis of the knee . It will assist in predicting individual risks of disease progression and would help to clarify pathophysiologic mechanisms of idiopathic osteoarthritis of the knee

Official Title
-----------------
Preventive and Personalized Medicine (2021-2023)

Conditions
-----------------
Idiopathic Osteoarthritis

Intervention / Treatment
-----------------
* Genetic: SNP analysis of the DNA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with bilateral idiopathic gonarthrosis aged 18 to 65 years; Representatives of the Kazakh ethnic group up to the 3rd generation; Hereditary history of arthrosis; Persons who are able and willing to provide written informed consent; Exclusion Criteria: Patients with bilateral idiopathic gonarthrosis under 18 years of age and over 65 years of age; Representatives of other ethnic groups; Representatives of the Kazakh ethnic group less than 3 generations; No family history of bilateral idiopathic gonarthrosis; Patients with an acute period of the inflammatory process (laboratory and clinical signs); Persons who, in the opinion of the researcher, are mentally or legally incapacitated, which prevents obtaining informed consent; Pregnant or lactating women; Tuberculosis of any localization in the active phase and in history; Severe and decompensated diseases of the liver and kidneys, cardiovascular system; Severe and decompensated course of endocrine diseases; Autoimmune diseases; Systemic diseases; Oncological diseases;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 68 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental group:<br>patients with idiopathic osteoarthritis of the knee | Genetic: SNP analysis of the DNA<br>* SNP analysis of the DNA obtained from peripheral blood sample<br>|
| Control group<br>patients without idiopathic osteoarthritis of the knee | Genetic: SNP analysis of the DNA<br>* SNP analysis of the DNA obtained from peripheral blood sample<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| enotyping for the SNP associated with liver cirrhosis | Genotype frequency of SNP in the study genes of participants and control participants. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SNP
Multicenter Study to Investigate SER120 Nasal Spray Formulations in Patients With Nocturia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the efficacy and safety of SER120 nasal spray formulations in patients with nocturia for a total duration of 14 weeks.

Official Title
-----------------
A Randomized, Double Blind, Placebo Controlled, Parallel Group, Multicenter Study to Investigate the Efficacy and Safety of SER120 Nasal Spray Formulations in Patients With Nocturia

Conditions
-----------------
Nocturia

Intervention / Treatment
-----------------
* Drug: SER120 (750 ng/day)
* Drug: SER120 (1000 ng/day)
* Drug: SER120 (1500 ng/day)
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female 50 years or older Nocturia of 6 or more months duration averaging greater than 2 nocturic episode per night Exclusion Criteria: CHF Diabetis Insipidus Renal Insufficiency Hepatic Insufficiency Incontinence Illness requiring systemic steroids Malignancy within the past 5 years Sleep Apnea Nephrotic Syndrome Unexplained Pelvic Mass Urinary Bladder Neurological dysfunction Urinary Bladder Surgery or Radiotherapy Pregnant or Breast Feeding

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SER120 (750 ng/day)<br>SER120 (750 ng/day) | Drug: SER120 (750 ng/day)<br> <br> |
| Experimental: SER120 (1000 ng/day)<br>SER120 (1000 ng/day) | Drug: SER120 (1000 ng/day)<br>* SER120 (1000 ng/day)<br>|
| Experimental: SER120 (1500 ng/day)<br>SER120 (1500 ng/day) | Drug: SER120 (1500 ng/day)<br> <br> |
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in # of Mean Nocturic Episodes Per Night | Change was calculated based on the number of mean nocturic episodes per night between baseline through week 12 | 12 weeks | 
| Percent of Participants With 50% or Greater in Reduction of Nocturic Episodes | Percent of participants achieving at least 50% reduction in mean nocturic episode per night during 12 weeks compared to baseline | 12 weeks |
Safety and Immune Response to Adjuvanted A(H1N1)v Influenza Vaccine in HIV-1 Infected and Immunosuppressed Adult Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the immunogenicity and safety of an adjuvanted A(H1N1)v influenza vaccine in HIV-infected and immunosuppressed patients after one and two injections.

Detailed Description
-----------------
The efficacy of an adjuvanted A(H1N1)v influenza vaccine in HIV-infected and immunosuppressed patients is unknown. Therefore we aim to investigate the immunoresponse as assessed by a anti-hemagglutinin assay before, 21 days after the first and 21 days after the second vaccination. The safety of the vaccination will be recorded by a standardized questionaire.

Official Title
-----------------
Safety and Immune Response to Adjuvanted A(H1N1)v Influenza Vaccine in HIV-1 Infected and Immunosuppressed Adults

Conditions
-----------------
HIV-1 Infection, Cancer, Immunosuppression

Intervention / Treatment
-----------------
* Other: serologic testing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: written informed consent age >18 HIV-1 infection cancer immunosuppressive treatment Exclusion Criteria: not willing to participate

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: serologic testing|Serologic testing will be performed baseline, day 21 and day 42|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the immunogenicity via anti-hemagglutinin responses following an adjuvanted H1N1 vaccination in HIV-positive and immunosuppressed adult patients |  | baseline, day 21, day 42 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the effect of pre-existing anti-influenza immunity and recent history of seasonal influenza and H5N1 vaccination on seroresponses to the H1N1 influenza vaccine |  | baseline | 
| To evaluate potential adverse reactions of the H1N1 vaccine |  | baseline, day 21, day 42 |