linjc16/ctgov huggingface dataset:
Bacterial Vaginosis in Pregnancy: Detection by Weekly Vaginal pH Testing

Study Overview
=================
Brief Summary
-----------------
Interventional study to assess the effect of early detection and treatment of bacterial vaginosis in pregnancy on preterm delivery rate.

Official Title
-----------------
Impact on Prematurity of a First-trimester Screening for Bacterial Vaginosis in Pregnancy Through Weekly Vaginal pH Determination. An Interventional, Community Study.

Conditions
-----------------
Pregnancy, Bacterial Vaginosis, Preterm Delivery

Intervention / Treatment
-----------------
* Other: Screening


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women Exclusion Criteria: Diabetes mellitus (pre-gestational) Hypertension (pre-gestational) Malformations on ultrasonography at 12 weeks
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Weekly screening<br>Screening and treatment of bacterial vaginosis during pregnancy through self-administered weekly vaginal pH determination. | Other: Screening<br>* Weekly vaginal pH<br>|
| No Intervention: Observation<br>Usual care | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preterm delivery rate |  | 12 months |
Predictive Value of Bio-impedance Vector Analysis on Long-term Outcome in ICU Patients

Study Overview
=================
Brief Summary
-----------------
Phase angle, derived from bioimpedance analysis (BIA), reflects tissue quality and quantity in which cell mass, membrane integrity and hydration state are represented. Phase angle, as a measure of body composition, changes with the physical condition of patients and is associated with survival in several disease states and during ICU admission. Aim of the study is to explore the predictive value of the phase angle for long term ICU outcome.

Detailed Description
-----------------
Phase angle, derived from bioimpedance analysis (BIA), reflects tissue quality and quantity in which cell mass, membrane integrity and hydration state are represented. Phase angle, as a measure of body composition, changes with the physical condition of patients and is associated with survival in several disease states and during ICU admission. Aim of the study is to explore the predictive value of the phase angle for long term ICU survival. A single-centre prospective observational cohort will be performed with consecutive patients, elective and non elective, admitted to the ICU between 1st June 2018 and 1st June 2019. Demographic data, APACHE III, comorbidity and phase angle are collected and the ICU- , hospital- and 6 months survival will be registered.

Official Title
-----------------
Predictive Value of Bio-impedance Vector Analysis on Long-term Outcome in ICU Patients

Conditions
-----------------
Long-term Outcome, Survival

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients admitted to the ICU, elective and acute. Exclusion Criteria: age below 18 Length of stay at ICU < 6 hours All invalid bio-impedence analysis (BIA) measurements

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 |
| --- | --- | --- |
| 3 months survival | 100% minus all-cause mortality at three month post ICU | 3 months | 
| 6 months survival | 100% minus all-cause mortality at six month post ICU | 6 months | 
| 12 months survival | 100% minus all-cause mortalityat twelve month post ICU | 12 months |
Fast Track in Open Colonic Surgery - A Multicentric Randomized Controlled Trial

Study Overview
=================
Brief Summary
-----------------
To investigate the real value of a fast track protocol compared to a standard care protocol regarding postoperative complications and hospital stay in a multicentric setting in an intention to treat fashion.

Detailed Description
-----------------
Our fast track protocol contains the four major components perioperative fluid restriction, epidural analgesia, early oral feeding and enforced mobilisation

Official Title
-----------------
Fast Track in Open Colonic Surgery - A Multicentric Randomized Controlled Trial

Conditions
-----------------
Elective Colectomie, Median Laparotomie

Intervention / Treatment
-----------------
* Procedure: Standard Care
* Procedure: Fast Track care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients admitted for open colonic surgery Exclusion Criteria: no primary anastomosis and/or stoma rectum resection emergency situation patients not speaking german immobile patients

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>Standard Care | Procedure: Standard Care<br>* standard fluid regime, delayed feeding<br>|
| Other: 2<br>Fast Track Care | Procedure: Fast Track care<br>* restrictive fluid regime, early oral feeding, enforced mobilisation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complications until 30 days after surgery according to the zurich classification |  | 30 days postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hospital stay, adherence to Fast track protocol |  | 30 days |
Sarcoma Database at KFSH&RC

Study Overview
=================
Brief Summary
-----------------
Sarcoma Database

Detailed Description
-----------------
Sarcoma Database

Official Title
-----------------
Sarcoma Database at KFSH&RC.

Conditions
-----------------
Sarcoma Database

Intervention / Treatment
-----------------
* Other: Database


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with diagnosed Sarcoma Exclusion Criteria: Patients with diagnosis other than Sarcoma

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 85 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Database|Database|

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
-----------------
Sarcoma Database
The Effect of Dexmedetomidine in Intraocular Pressure During Robot-Assisted Laparoscopic Radical Prostatectomy

Study Overview
=================
Brief Summary
-----------------
Intraocular pressure is significantly increase during robot-assisted laparoscopic radical prostatectomy which is performed in a steep trendelenburg position at prolonged timeds of pneumoperitoneum. Threrefore we decided to evaluate the effect of dexmedetomidine in intraocular pressure during roboti-assisted laparoscopic radical prostatectomy.

Conditions
-----------------
Steep Trendelenburg Position With Penumoperitoneum in Robot Assisted Laparoscopic Prostatectomy

Intervention / Treatment
-----------------
* Drug: Dexmedetomidine
* Drug: saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA class I-II obtaining written informed consent from the parents aged 20-70 years who were undergoing robot- assited laparoscopic prostatectomy Exclusion Criteria: eye surgery prevoiusly unstable angina or congestive heart failure concomittant eye disease (glaucoma, diabetic retinophaty, cataract, retinal detachment) high intraocular pressure over 30mmHg after screening test. uncontrolled hypertension (diastolic bp>110mmHg) bradycardia under 60bpm Ventricular conduction abnormality hepatic failure renal failure drug hyperactivity neurological or psychiatric illnesses mental retardation patients who can't read the consent form due to illiterate or foreigner

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dexmedetomidine<br>dexmedetomidine infusion from beginning of the anesthesia to just before returning to horizontal position | Drug: Dexmedetomidine<br> <br> |
| Placebo Comparator: saline<br>Saline infusion from same time period. | Drug: saline<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Influence of dexmedetomidine in intraocular pressure during robot-assisted laparoscopic prostatectomy. | T0: Pre-induciton T1: 5min after anesthesia induction T2: 5 min after establish pneumoperitoneum T3: 15min after steep trendelenburg position T4: 30min after steep trendelenburg position T5: 45min after steep trendelenburg T6: 60min after steep trendelenburg T7: 75min after steep trendelenburg T8: 5min after returning to horizontal position T9: operation end T10: 5min after tracheal extubation T11: 60min after tracheal extubation | change of intraocular pressure from T0 to T11 for 60mins | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DEXMEDETOMIDINE, intraocular pressure
Genetic Studies in Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
Alzheimer's disease is a condition marked by the deterioration of mental function. The disease usually begins in late middle life and results in death in 5 to 10 years. Patients with Alzheimer's disease typically suffer from memory loss, confusion, and disorientation. The condition has become a major medical and social problem in the United States because of the increasing number of people living beyond the age of 65. The actual cause of Alzheimer's disease is unknown. Researchers believe that Alzheimer's disease, or at least a portion of cases, may be an inherited condition. As a result, many new techniques have been developed to study the genetic causes of Alzheimer's disease and other neurological disorders. Many of these genetic techniques require blood samples and a family pedigree. A pedigree is a chart, similar to a family tree, that shows a patient's family history. The purpose of this study is to collect family and psychosocial information, blood, and biopsy samples from patients with neurological diseases, their families, and normal volunteers. This information gathered will be used to learn more about diseases that affect the brain.

Detailed Description
-----------------
This is a screening and follow-up Protocol. Recent technological advances have facilitated the development of new approaches for investigating the underlying genetic basis of neurological disorders, but genetic questions remain open and on going. Application of many genetic techniques require a family pedigree and blood sample. Peripheral blood lymphoblasts which are banked also serve as a renewable source for harvesting DNA which can be used for developing genetic markers in the future. This study will allow collection of family and psychosocial information and blood specimens from patients with neurological diseases, their families, and normal control subjects.

Official Title
-----------------
Biochemical and Genetic Studies in Familial Alzheimer's Disease

Conditions
-----------------
Alzheimer's Disease, Nervous System Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION/EXCLUSION CRITERIA Need to know extensive family history information.
Sexes Eligible for Study
-----------------
All

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

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DNA, Primary Neuronal Degeneration, Genetics, Neurotransmitters, Lymphoblasts, Skin Fibroblast, Alzheimer's Disease
A Study to Evaluate the Safety and Performance of ArterX™ Vascular Sealant in Sealing Synthetic Arterial Grafts

Study Overview
=================
Brief Summary
-----------------
A prospective, multi-center study to evaluate the safety and performance outcomes of the ArterX Vascular Sealant when used for prophylactic sealing of suture lines at the anastomosis between native vessel and synthetic vascular grafts.

Official Title
-----------------
A Study to Evaluate the Safety and Performance of ArterX™ Vascular Sealant in Sealing Synthetic Arterial Grafts

Conditions
-----------------
Vascular Disease

Intervention / Treatment
-----------------
* Device: ArterX Vascular Sealant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The subject must be ≥ 18 years old The subject must be scheduled for surgical placement of a synthetic graft for large vessel repair/ arterial reconstruction/ hemodialysis access. The subject has no child bearing potential or has a negative serum or urine pregnancy test within 7 days of the index procedure. The subject is willing and able to be contacted for minimum of 6 weeks follow up. The subject or guardian must provide written informed consent using a form that is reviewed and approved by the Ethics Committee. Exclusion Criteria: The subject has a known hypersensitivity or contraindication to heparin, bovine or seafood products. The subject has a history of bleeding diathesis or coagulopathy, or will refuse blood transfusion. The subject is currently enrolled in this, or another investigational device or drug trail that has not completed the required follow-up period. ArterX Vascular Sealant should not be used in patients who have exhibited an allergic reaction to materials of shellfish or bovine origin.

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: ArterX Vascular Sealant<br> | Device: ArterX Vascular Sealant<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of anastomoses with immediate sealing of the suture line | Immediate suture line sealing on clamp removal, as evidenced by a lack of clinically significant bleeding. A minimum of 50% of the anastomoses were expected to be sealed immediately. | Intraoperative |
Safety and Efficacy Study of DE-104 Ophthalmic Solution to Treat Open-Angle Glaucoma or Ocular Hypertension

Study Overview
=================
Brief Summary
-----------------
To investigate the dose-response relationship of DE-104 ophthalmic solution in lowering intraocular pressure (IOP) in subjects with Primary Open-Angle Glaucoma or Ocular Hypertension

Official Title
-----------------
A Randomized, Double-Masked, Parallel-Group, Dose-Response Trial of DE-104 Ophthalmic Solution in Subjects With Open-Angle Glaucoma or Ocular Hypertension

Conditions
-----------------
Open-Angle Glaucoma, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: DE-104 ophthalmic solution, low concentration
* Drug: DE-104 ophthalmic solution, medium concentration
* Drug: DE-104 ophthalmic solution, high concentration
* Drug: DE-104 vehicle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with primary open-angle glaucoma or ocular hypertension. Provided signed, written informed consent. If a subject is a female of childbearing potential, she must utilize reliable contraceptive throughout the study, and must have a negative urine pregnancy test prior to enrollment into this study. Exclusion Criteria: Females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception. Presence of any abnormality or significant illness that could be expected to interfere with the study.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 74 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 |
| --- | --- |
| Experimental: 1<br> | Drug: DE-104 ophthalmic solution, low concentration<br> <br> |
| Experimental: 2<br> | Drug: DE-104 ophthalmic solution, medium concentration<br> <br> |
| Experimental: 3<br> | Drug: DE-104 ophthalmic solution, high concentration<br> <br> |
| Placebo Comparator: 4<br> | Drug: DE-104 vehicle<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Safety, Tolerability & PK of AZD0328 in Caucasian & Japanese

Study Overview
=================
Brief Summary
-----------------
This study will be performed to evaluate the safety, tolerability and pharmacokinetics of single and multiple doses of AZD0328 when administered to Japanese and Caucasian healthy male volunteers.

Official Title
-----------------
A Phase I, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD0328 in Healthy Young Japanese and Caucasian Male Volunteers After Oral Single and Multiple Ascending Doses

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: AZD0328


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: first generation Japanese (both parents and grandparents are Japanese, the subject is born in Japan and left Japan less than 10 years ago) or Caucasian subjects. Clinically normal physical findings, laboratory values, vital signs and resting ECG as judged by the investigator. Exclusion Criteria: History of clinically significant cardio- or cerebrovascular, pulmonary, renal, hepatic, neurological, mental or gastrointestinal disorder or any other major disorder that may interfere with the study. Participation in another study within 12 weeks before the first administration of the investigational product. Intake of any prescribed medicine or herbal remedies based on St John's Wort, except for occasional paracetamol and nasal adrenergic anticongestants, within 3 weeks before the first administration of the investigational product.

Ages Eligible for Study
-----------------
Minimum Age: 20 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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: AZD0328<br>* Oral solution A single dose Day 1 followed by once daily doses on Day 3-7<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety variables (adverse events, vital signs, paper ECGs and 12-lead continuous digital ECGs including QT/QTc interval measurements |  | During the whole treatment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK variables |  | Several samples during the study days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AZD0328, Japanese, Caucasian, pharmacokinetics, safety, tolerability