linjc16/ctgov huggingface dataset:
Metabolic Syndrome Risk Factor in IGT: STOP-NIDDM Trial

Study Overview
=================
Brief Summary
-----------------
The aim of the study was to analyse the independent and joint effects of the components of the metabolic syndrome (MetS) on the incidence of diabetes in people with impaired glucose tolerance (IGT) and to assess the effect of acarbose by MetS status. Double-blind placebo controlled trial, 1,368 patients, follow-up time 3.3 years. MetS by ATP III definition with fasting plasma glucose of ≥ 6.1 mmol/l as limit for impaired fasting glucose (IFG).

Official Title
-----------------
Metabolic Syndrome and Its Single Traits as Risk Factors of Diabetes in People With Impaired Glucose Tolerance: The STOP-NIDDM Trial

Conditions
-----------------
Metabolic Syndrome

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: High risk population Age 40 to 70 yrs. BMI > 25 and < 40; FPG >5.5 mmol/l and < 7.8 mmol/l; IGT in OGGT Exclusion Criteria: Known type 2 diabetes Drug intake affecting glucose tolerance Any cardiovascular events within the last 6 months

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 70 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Drug: acarbose<br> <br> |
| Placebo Comparator: 2<br> | Drug: placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of newly diagnosed type 2 diabetes |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| newly diagnosed hypertension |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prevention,, type 2 diabetes,, metabolic syndrome,, acarbose treatment
A Study to Evaluate Infants With Potential Exposure to Tanezumab Before Birth

Study Overview
=================
Brief Summary
-----------------
This study will examine post-natal neurologic and cognitive development of infants who may have been exposed to tanezumab or comparator in-utero during the tanezumab clinical program (whether the exposure is through maternal or paternal participation in a tanezumab clinical study).

Detailed Description
-----------------
This study will enroll infants with potential tanezumab exposure in utero at sites overseen by Schulman and Associates IRB This study will attempt to enroll all infants who qualify.

Official Title
-----------------
A Protocol to Monitor the Neurological Development of Infants With Exposure In-utero From Birth to Aged 15 Months in Tanezumab Clinical Studies at Investigational Sites Overseen by Schulman and Associates Institutional Review Board

Conditions
-----------------
Infant Developmental Assessment

Intervention / Treatment
-----------------
* Other: Unintentional exposure in utero


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is an infant born to a mother who was exposed to study drug on a tanezumab clinical study through direct maternal exposure; or is an infant born to a mother who is a partner of a male patient who was exposed to study drug in a tanezumab clinical study prior to or around the time of conception and/or is exposed during his partner's pregnancy. Exclusion Criteria: There are no exclusion criteria for this study

Ages Eligible for Study
-----------------
Maximum Age: 15 Months

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Infants with potential exposure in utero<br> | Other: Unintentional exposure in utero<br>* This study will examine post-natal neurologic and cognitive development of infants who may have been exposed to tanezumab or comparator in-utero during the tanezumab clinical program (whether the exposure is through maternal or paternal participation in a tanezumab clinical study).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bayley Infant Neurodevelopmental Screener |  | 0-2 Months | 
| Bayley Infant Neurodevelopmental Screener |  | 8 months | 
| Bayley Infant Neurodevelopmental Screener |  | 15 months | 
| Receptive-Expressive Emergent Language Test |  | 0-2 Months | 
| Receptive-Expressive Emergent Language Test |  | 8 months | 
| Receptive-Expressive Emergent Language Test |  | 15 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
post-natal monitoring, exposure in utero
Comparison of Optic Nerve Sheath Diameter on Retrobulbar Ultrasonography Before and After Drainage of Cerebrospinal Fluid in Pediatric Patient With Hydrocephalus

Study Overview
=================
Brief Summary
-----------------
Studies in patients with intracranial hypertension have shown a good relationship between optic nerve sheath diameter measured by retrobulbar ultrasound and invasively measured intracranial pressure. The aim of this study was to evaluate changes in optic nerve sheath diameter before and after drainage of cerebrospinal fluid in patients with hydrocephalus.

Conditions
-----------------
Hydrocephalus

Intervention / Treatment
-----------------
* Procedure: retrobulbar ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA Ⅰ-Ⅱ aged between 1 and 19 year hydrocephalus general anesthesia for undergoing drainage of cerebrospinal fluid Exclusion Criteria: 1. an anatomical or functional abnormality in optic nerve

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 19 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 |
| --- | --- |
| both optic nerve sheath diameter<br> | Procedure: retrobulbar ultrasound<br>* both optic nerve sheath diameter (the posterior 3mm of the papilla), 5 individual measurement<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| both optic nerve sheath diameter (the posterior 3mm of the papilla) |  | For day 1 from induction of general anesthesia to average 15 min after recovery of general anesthesia | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Child, Optic nerve sheath diameter, Hydrocephalus, Intracranial hypertension
Safety and Immunogenicity of a Booster Dose of -H5N1 Influenza Vaccine

Study Overview
=================
Brief Summary
-----------------
To assess persistence of antibody titers 17-18 months after primary immunization with two 0.5mL intramuscular (IM) doses of H5N1 influenza vaccine containing H5N1 influenza antigen, as measured by Hemagglutination Inhibition (HI), Single Radial Hemolysis (SRH), and Microneutralization (MN) test

Official Title
-----------------
A Phase II, Open-label, Multi-Center Study to Evaluate Safety and Immunogenicity of a Booster Dose of -H5N1 (Surface Antigen Adjuvanted With MF59C.1) Influenza Vaccine in Non-elderly Adult and Elderly Subjects

Conditions
-----------------
Avian Influenza

Intervention / Treatment
-----------------
* Biological: H5N1 influenza vaccine
* Biological: H5N1 influenza vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy subjects who previously participated in study V87P1, but did not receive the booster dose on day 202 Exclusion Criteria: Pregnant or breastfeeding Receipt of another vaccine or any investigational agent within the past 4 weeks Surgery planned during the study period

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Biological: H5N1 influenza vaccine<br>* One 0.5 ml booster injection 12 months after the second injection, of influenza vaccine containing 7.5 micrograms of H5N1 influenza antigen<br>|
| Experimental: 2<br> | Biological: H5N1 influenza vaccine<br>* One 0.5 ml booster injection 12 months after the second injection, of influenza vaccine containing 15.0 micrograms of H5N1 influenza antigen<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and percentage of subjects with at least one local reaction between 1 and 7 days after vaccination. |  | 7 days | 
| Number and percentage of subjects with at least one systemic reaction between 1 and 7 days after vaccination. |  | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and percentage of subjects with at least one adverse event between day of vaccination and the study termination visit.Safety will be assessed in accordance with available safety data on influenza vaccines. |  | 8 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
H5N1 Pandemic
Comparison of Quality of Supraclavicular, Infraclavicular and Axillary Approach of Ultrasound-guided Brachial Plexus Block

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to compare the quality of 3 methods of ultrasound-guided brachial plexus blocks for surgical anesthesia

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: Bupivacaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I-III physical status Surgery of distal arm, forearm or hand Exclusion Criteria: Skin infection near block injection site Allergy to local anesthetics Peripheral neuropathy upper limb INR of more than 1.4 Thrombocytopenia Opioid dependency Chronic pain syndrome Lack of orientation to person, place and time Patient refusal

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SCL<br>Supraclavicular ultrasound-guided brachial plexus block | Drug: Bupivacaine<br>* Bupivacaine 5 mg/cc with adrenaline 5 mcg/cc will be injected with complete spread of the drug around nerves.<br>|
| Active Comparator: ICL<br>Infraclavicular ultrasound-guided brachial plexus block | Drug: Bupivacaine<br>* Bupivacaine 5 mg/cc with adrenaline 5 mcg/cc will be injected with complete spread of the drug around nerves.<br>|
| Active Comparator: AX<br>Axillary ultrasound-guided brachial plexus block | Drug: Bupivacaine<br>* Bupivacaine 5 mg/cc with adrenaline 5 mcg/cc will be injected with complete spread of the drug around nerves.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of 3 different approaches to brachial plexus block | Whether or not there is need for additional analgesic drugs or need to switch to general anesthesia | Immediate | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
relief, Intra-operative
Sexuality After Different Mode of Deliveris

Study Overview
=================
Brief Summary
-----------------
Pregnancy and delivery usually affect the general women's quality of life. Some studies have reported that sexual health may be affected by the mode of delivery. More than 70% of pregnant women prefer C-section due to several reasons point out the fear of pain and complications of vaginal delivery as the most common reasons. Aim of the work: To explore the relationship between quality of life and the possible sexual dysfunction after normal vaginal in comparison to cesarean section deliveries.

Official Title
-----------------
Effect of the Mode of Delivery on Sexual Functions and Quality of Life Among a Group of Egyptian Women

Conditions
-----------------
Sexual Dysfunction and the Mode of Deliveries

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primiparas women who had been delivered by either vaginal or cesarean section about 6-12months. All included women should be officially married Exclusion Criteria: Women with history of sexual dysfunction Women with history of any pelvic surgery apart from Cesarean. history of anti-depressive drug therapy. history of genital prolapse history of Diabetes mellitus loss of any family member or unfaveorouble neonatal outcome or childdeath Divorce experience family problems and cases who were not interested in participation

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 30 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| vaginal group<br> | |
| cesarean section group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life after delivery | the amplitude of many changes occur during and after pregnancy, which affect physical, psychological and social health and generally women's quality of life | one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the relationship between quality of life and sexual dysfunction after both modes delivery |  | one month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mode of delivery, quality of life, sexuality
Prophylactic Antibiotic Treatment for Hand Lacerations Involving Flexor and/or Extensor Tendon

Study Overview
=================
Brief Summary
-----------------
The investigators assume that simple hand lacerations involving flexors or extensors tendons, do not require prophylactic antibiotic treatment to prevent wound infection.

Detailed Description
-----------------
Hand lacerations are divided to complicated which involves tendons, nerves, bones, and joints, and simple which involves only cutaneous and subcutaneous tissue. prophylactic antibiotic should not be given in a clean simple lacerations, and should be given when a bone is involve (open fracture). But there is not enough data, weather prophylactic antibiotic treatment should be given when only tendons are involved. The investigators will examine 2 groups of 30 patients each with clean hand lacerations involving tendons. One group will be treated with prophylactic antibiotic and the other wont be treated, randomly. The investigators assume that the rate of wound infection wont be different between the 2 groups.

Official Title
-----------------
Prophylactic Antibiotic Treatment for Hand Lacerations Involving Flexor and/or Extensor Tendon

Conditions
-----------------
Hand Laceration, Tendon Involved, Clean Laceration, No Bone Involved

Intervention / Treatment
-----------------
* Drug: Antibiotic-Cefamezin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hand laceration Tendon involeved Clean laceration No bone involved Exclusion Criteria: Pregnant Children Immunocompremised patients Dirty lacerations

Ages Eligible for Study
-----------------
Minimum Age: 13 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: with antibiotic and without antibiotic<br> | Drug: Antibiotic-Cefamezin<br> <br> * Other names: Keflex;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of wound infections | signs of wound/tissue infection, levels of WBC, ESR, CRP | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lacerations, Tendons, Antobiotic
Fistulotomy Versus Fistulotomy With Marsupialization

Study Overview
=================
Brief Summary
-----------------
It was a study comparing two standard procedures for fistula in ano

Detailed Description
-----------------
It was a study which compared two standard surgical procedures for fistula in ano

Official Title
-----------------
Fistulotomy Versus Fistulotomy With Marsupialization, a Randomized Controlled Trial

Conditions
-----------------
Fistula in Ano

Intervention / Treatment
-----------------
* Procedure: standard fistulotomy
* Procedure: fistulotomy with marsupialization


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: having low lying anal fistula Willing to enroll in study Exclusion Criteria: unfit pts Having uncontrolled diabetes

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Fistulotomy<br>Standard fistulotomy was done in this arm | Procedure: standard fistulotomy<br>* in a standard manner fistula tract was identified and laid open without doing marsupialization<br>Procedure: fistulotomy with marsupialization<br>* in this arm fistulotomy was done in a standard manner and marsupialization was done<br>|
| Other: Fistulotomy with marsupialization<br>This arm consists of fistulotomy in which marsupialization was done | Procedure: standard fistulotomy<br>* in a standard manner fistula tract was identified and laid open without doing marsupialization<br>Procedure: fistulotomy with marsupialization<br>* in this arm fistulotomy was done in a standard manner and marsupialization was done<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of healing time in fistula in ano with and without marsupialization | We measured the healing time between two groups | 1year |
Closure of Peritoneum at Cesarean Section and Postoperative Adhesion

Study Overview
=================
Brief Summary
-----------------
Objective: To determine the effect of non-closure of the visceral and parietal peritoneum during Cesarean section on the formation of adhesions. Study design: A prospective randomized trial of 533 women undergoing primary Cesarean section; 256 were randomized to non closure and 277 to closure of the peritoneum. At a subsequent cesarean,he presence of adhesions and their severity was evaluated at several sites: between the layers of the abdominal wall, between the bladder and the abdominal wall, between bladder and uterus, between the uterus and the abdominal wall, and between the bowels and the pelvic organs. A cumulative adhesion score was calculated.

Official Title
-----------------
Effects of Closure Versus Non-closure of the Visceral and Parietal Peritoneum at Cesarean Section on Adhesions: A Prospective Randomized Study

Conditions
-----------------
Cesarean Section, Adhesions

Intervention / Treatment
-----------------
* Procedure: Closure of the peritoneum at cs


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women undergoing primary CS Exclusion Criteria: Lack of consent by the patient or an urgent cesarean not allowing time to elicit an informed consent Previous pelvic or abdominal surgery

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: peritoneal closure<br> | Procedure: Closure of the peritoneum at cs<br>* Injection of 5 mg Marcaine (anesthetic solution) to the leg<br>|
| No Intervention: Non closure of the peritoneum<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adhesion score |  | 6 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Formation of adhesions assessed at subsequent cs
Eribulin in mTNBC Patients

Study Overview
=================
Brief Summary
-----------------
To evaluate the efficacy and safety of Eribulin in patients with advanced breast cancer.

Official Title
-----------------
An Observational, Retrospective Study of Eribulin in Advanced Breast Cancer

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Advanced breast cancer included unresectable locally advanced breast cancer, de novo stage IV breast cancer, and recurrent metastatic breast cancer. Eribulin treatment of advanced breast cancer for at least one cycle, between Dec 2019 and Aug 2020. Available medical history. Exclusion Criteria: 1. Incomplete medical history.
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Eribulin<br>Eribulin 1.4mg/m2 d1,8 iv q3w | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | Progression free survival | 6 weeks | 
| Adverse events | Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0) | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Eribulin, TNBC