linjc16/ctgov huggingface dataset:
Use of Sentinel Cells for the Development of Molecular Tests to Control the Quality of Cryopreservation

Study Overview
=================
Brief Summary
-----------------
The aim is to set up tools that will serve as quality tracers for cryopreservation procedures. To meet this objective, we have chosen to develop reference samples (sentinel cells) that, in the medium term, can be used as controls to guarantee the quality of preservation for biological samples. The biological tools and an optimised follow-up strategy will make it possible to validate preservation procedures at the CRB in order to guarantee the perfect stability of samples and the validity of clinical studies.

Conditions
-----------------
Aneurysm of the Abdominal Aorta

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > or = 18 years All patients presenting an abdominal aorta diameter of at least 5 cm at the time of discovery and who have surgery Exclusion Criteria: Patients who do not have aneurysm of the abdominal aorta Refusal to sign the consent form for participation Patients who do not wish to have their operation in Dijon or Strasbourg CHU

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality sentinel cells |  | participants will be followed for the duration of hospital stay, an expected average of 6 months |
Testing a Modified Family Planning Intervention for Postpartum Women in Uganda

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test whether offering incentives to encourage women to attend one-on-one family planning education sessions and offering free, onsite prescription contraceptive methods increases use and continuation of prescription contraception among postpartum women in Uganda. This intervention is modified from one that has been effective outside of Uganda.

Official Title
-----------------
Modification of an Evidence-based Family Planning Intervention for a New Target Population: Postpartum Women in Nakaseke District, Uganda - Pilot Phase, Two Arm

Conditions
-----------------
Contraceptive Usage

Intervention / Treatment
-----------------
* Behavioral: Contraceptive management program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-45 years of age Not planning on getting pregnant in the next 4 months Less than 3 months postpartum No history of tubal ligation or hysterectomy No recent prescription contraceptive use (no pill, intrauterine device or implant use in the past 7 days or injection use in the past 3 months) Medically eligible to use prescription contraceptives Bringing baby to immunization clinic for the first time Exclusion Criteria: Failure to meet the aforementioned inclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Contraceptive management program<br> | Behavioral: Contraceptive management program<br>* The contraceptive management program will consist of two components: (1) the World Health Organization's contraception protocol and (2) incentivized visits.<br>|
| No Intervention: Usual care<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Period prevalence use of a prescription contraceptive | Period prevalence use of a prescription contraceptive | 6 months after delivery |
Plasma Adiponectin Concentration, Activity and Isoforms in Newly Diagnosed and Untreated Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
The objective of present study were to compare plasma adiponectin isoform status, their bioactivities newly diagnosed Chinese with healthy volunteer.

Detailed Description
-----------------
Adiponectin, circulates as trimer, hexamer and high molecular weight form (HMW) in human blood, is a promising biomarker for indication diabetes and cardiovascular disease. Both adiponectin complexes concentration and their bioactivities are decreased in pathological state. Disulﬁde-bond A oxidoreductase-like protein (DsbA-L) is a key regulator for adiponectin biosynthesis and its expression level is down-regulated in obese mice and humans. However, the alteration of circulating adiponectin multimers distribution, their bioactivities and adiponectin regulator, DsbA-L level, in newly diagnosed Chinese type 2 diabetes patients are unknown. The objective of present study were to compare plasma adiponectin isoform status, their bioactivities and DsbA-L concentration in newly diagnosed Chinese with healthy volunteer.

Official Title
-----------------
Plasma Adiponectin Concentration, Activity and Isoforms in Newly Diagnosed and Untreated T2DM Patients in Chinese Population

Conditions
-----------------
Diabetes Mellitus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Having a diabetic history within 12 months BMI smaller than 30kg/m2 Exclusion Criteria: Having any kinds of treatment affecting glucose pregnant uncontrolled hypertension, active cardiac disease, or other major liver, kidney disease

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 70 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 |
| --- | --- |
| T2DM patients<br>newly diagnosed T2DM patients and untreated with any drugs. | |
| Non-diabetic Control Group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma adiponectin concentration, isoform distribution and activity. |  | participants will be followed for the duration of hospital stay, an expected average of 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes mellitus
Nasopharyngeal Airway Facilitate Transnasal Humidified Rapid Insufflation Ventilatory Exchange

Study Overview
=================
Brief Summary
-----------------
For performing transnasal humidified rapid insufflation ventilatory exchange (THRIVE), jaw-thrust maneuver have to maintain to make sure the airway open and the CO2 clearance during apnoea. The objective of present study is to prove that nasopharyngeal airway facilitate THRIVE and no need jaw-thrust maneuver and maintain the similar PO2 and PCO2 during apnoea.

Official Title
-----------------
Nasopharyngeal Airway Facilitate Transnasal Humidified Rapid Insufflation Ventilatory Exchange

Conditions
-----------------
Hypoxia, Hypercapnia

Intervention / Treatment
-----------------
* Device: Nasopharyngeal airway


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent. Undergoing surgery with general anaesthesia. Adult, >18 years old. American Society of Anesthesiology classification I-II. Exclusion Criteria: Coagulation disorders or a tendency of nose bleeding An episode/exacerbation of congestive heart failure (CHF) that requires a change in medication, diet or hospitalization from any cause in the last 6 months Severe aortic stenosis or mitral stenosis; Cardiac surgery involving thoracotomy (e.g., coronary artery bypass graft (CABG), valve replacement surgery) in the last 6 months; Acute myocardial infarction in the last 6 months; Acute arrhythmia (including both tachycardia and bradycardia) with hemodynamic instability; Diagnosed COPD or current other acute or chronic lung disease requiring supplemental chronic or intermittent oxygen therapy); Increased intracranial pressure; ASA >II; Mouth, nose, or throat infection; Fever, defined as core body temperature > 37.5°C; Pregnancy, breastfeeding or positive pregnancy test; Emergency procedure. Patient with known or suspected difficult airway

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: THRIVE<br>Transnasal humidified rapid-insufflation ventilatory exchange (THRIVE) during induction using jaw-thrust maneuver. | |
| Active Comparator: THRIVE with nasopharyngeal airway<br>Transnasal humidified rapid-insufflation ventilatory exchange (THRIVE) during induction with nasopharyngeal airway. | Device: Nasopharyngeal airway<br>* THRIVE with a regular nasopharyngeal airway.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The partial pressure of carbon dioxide (pCO2) |  | From start to end of THRIVE(20 minutes) | 
| The partial pressure of oxygen(PO2) |  | From start to end of THRIVE(20 minutes) |
Stability Plus - Outcomes From Extended Continuum of Care

Study Overview
=================
Brief Summary
-----------------
Basic Protocol Identify participant(s) Request patient participation/Acquire Consent Register patient at www.stabilityplus.net through the LOGIN tab Patient ID (Name/Initials/SSN or any combination thereof) Gender Age Surgical Procedure Date of Surgery Select Basic Exercise Program that corresponds with Surgical Procedure Perform Initial Assessment using Basic Exercises for the Surgical Procedure Enter Assessment Data at www.stabilityplus.net (through the LOGIN tab/Portal) Within portal, modify Basic Exercise Program to create customized Stability Plus prescription for the patient Monitor patient progress through Stability Plus portal.

Official Title
-----------------
Study the Effects of Pre- and Post-Operative Resistive Exercise in Total Arthroplasty Patients Using the Stability Plus Exercise System

Conditions
-----------------
Arthroplasty

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Undergone total joint replacement Must be able to complete pre-operative strength assessment Must be able to exercise using specified resistive bands Exclusion Criteria: Non-ambulatory patients
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 |
| --- | --- |
| M, 1<br>Male patients that have undergone total knee replacement | |
| F, 1<br>Female patients that have undergone total knee replacement | |
| M, 2<br>Male patients that have undergone total hip replacement | |
| F, 2<br>Female patients that have undergone total hip replacement | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre- and post- study strength assessment tests for joint specific exercises |  | 3 months, 6 months and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduced recovery time versus current norm |  | 3 months, 6 months and 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Resistance, Exercise
Characteristics and the Future of the City Chilblains

Study Overview
=================
Brief Summary
-----------------
Chilblains are cutaneous lesions affecting extremities (foot and fingers) with erythemic papules, evolving by painful relapse due to cold and sudden reheating. This pathology is currently poorly understood while it's frequent. The aim of the study is to evaluate all the characteristics of this pathology by reporting clinical and biological data of patient consulting for chilblains; and the other point is to assess the evolution of these patients.

Detailed Description
-----------------
Investigators are going to collect data on patient medical report to fill up a case report form. And in a second time they call patient by phone to ask him/her about the evolution of their pathology.

Official Title
-----------------
Characteristics and the Future of the City Chilblains

Conditions
-----------------
Chilblains

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient consulting for chilblains diagnostic of chilblain during the consultation Exclusion Criteria: patients consulting for other reason than chilblains patient who can't reply by telephonic call

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- | --- |
| Évaluation of chilblains' topography | This assessment consists to evaluate the chilblains topography, vasospastic profile and presence or not of another acrosyndrome | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaire of assessment of chilblains' evolution |  | 2 months |
Liposomal Based Intranasal Influenza Vaccine:Safety and Efficacy

Study Overview
=================
Brief Summary
-----------------
Influnza vaccination is highly recommended over the age of 50,but is only 50% efficatious among the elderly. A Vaccine given as a nasal spray may improve compliance and local immunity.Liposomes are lipid particles that may serve as carriers for the vaccine and together they enhance the local immune response in mice when given as nasal spray.This study aims to examine the safety and nasal and humoral responses to the nasal vaccine compared to the commercial muscular vaccine.

Official Title
-----------------
Phase 1 Study to Examine the Safety and Efficacy of a Novel Liposomal Based Intranasal Influenza Vaccine

Conditions
-----------------
Influenza

Intervention / Treatment
-----------------
* Biological: Vaccination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:Healthy young(20-45years old) and elderly(65-95 years old) volunteers - Exclusion Criteria:Known allergy to eggs and to the flu vaccine, pregnant and breast feeding women, chronic viral carriers, recently hospitalized persons -

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 95 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
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Vaccination|nan|

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

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibody levels |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intranasal vaccination, Influenza
An Open Study to Investigate the Safety and Efficacy of Replenine®-VF in Severe Haemophilia B Patients

Study Overview
=================
Brief Summary
-----------------
To compare the first and second recovery assessments on Replenine®-VF and to evaluate recovery of different batches if patients changed batches during the study. To evaluate Replenine®-VF in terms of long-term clinical efficacy, tolerance and safety

Official Title
-----------------
An Open Study to Investigate the Safety and Efficacy of Replenine®-VF in Severe Haemophilia B Patients.

Conditions
-----------------
Haemophilia B

Intervention / Treatment
-----------------
* Biological: Replenine®-VF (High Purity Factor IX)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Previously treated patients At least 12 years of age Severe Haemophilia B and without inhibitor to factor IX Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Replenine®-VF<br> | Biological: Replenine®-VF (High Purity Factor IX)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery calculated from the first infusion of Replenine®-VF compared with that calculated 12 weeks later. | Safety assessments included: assessment of tolerance at injection site assessment of Factor IX inhibitor development assessment of frequency and type of adverse event routine biochemistry and haematology at the start and end of Stage 1 and at the end of the study (Stage 2, if applicable) screening for markers of viral infection at the start and end of each stage of the study (and if patients changed batches). | Baseline and 3 months post-baseline. |
Acceptability and Feasibility of a Simplified Medical Abortion Service Delivery in Western Ukraine

Study Overview
=================
Brief Summary
-----------------
The study will examine how a simplified outpatient medical abortion procedure using mifepristone and misoprostol, with the option to take mifepristone at a place of woman's choosing, works in Ukraine. The investigators intend to demonstrate the efficacy of oral administration of 200 mg mifepristone and buccal administration of 800 mcg misoprostol with gestations through 70 days, as well as the acceptability of this method.

Official Title
-----------------
Acceptability and Feasibility of a Simplified Medical Abortion Service Delivery in Western Ukraine: A Demonstration Study of 800 mcg Buccal Misoprostol Following 200 mg Mifepristone for Abortion up to 70 Days Gestation

Conditions
-----------------
Abortion, Therapeutic

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have an intrauterine pregnancy consistent with gestational age less than 71 days; Be able to understand and willing to sign a consent form; Be eligible for medical abortion according to the clinician's assessment; Be able to return to the clinic and able to contact study staff or emergency medical services, if needed; Be willing to provide an address and/or telephone number for purposes of follow-up; Agree to comply with the study procedures and visit schedule. Exclusion Criteria: Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass; Chronic renal failure; Concurrent long-term corticosteroid therapy; History of allergy to mifepristone, or misoprostol or another prostaglandin; History of hemorrhagic disorders or concurrent anticoagulant therapy; History of inherited porphyrias; Intrauterine device in place (must be removed before mifepristone is administered).
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Simplified medical abortion<br>Women seeking medical abortion will be offered the option self-administering the medications, mifepristone and misoprostol at home. | Drug: Mifepristone<br>* Women seeking medical abortion will be offered the option to take mifepristone at home<br>Drug: Misoprostol<br>* Women seeking medical abortion will be offered the option to take misoprostol at home. Misoprostol will be administered buccally.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of successful abortion |  | 2 weeks after mifepristone administration |