linjc16/ctgov huggingface dataset:
Are Cesarean Section and Appendectomy in Pregnancy and Puerperium Interrelated?

Study Overview
=================
Brief Summary
-----------------
It is not known whether appendectomy for acute appendicitis (AA) increases the Cesarean section (CS) rate and whether CS increases the likelihood of AA and appendectomy in the early puerperium. In this study, delivery type and delivery outcomes and appendectomy during pregnancy and puerperium were analyzed.

Detailed Description
-----------------
This cross-sectional retrospective study was performed on 11513 women, delivered during 2015-2020. Inclusion criteria were patients submitted to appendectomy for AA during pregnancy and the first six weeks after delivery. Evaluating parameters were age, parity, gestational week at birth, delivery type, and babies' birth weight.

Official Title
-----------------
Are Cesarean Section and Appendectomy in Pregnancy and Puerperium Interrelated?

Conditions
-----------------
Appendicitis Acute, Cesarean Wound Disruption With Postnatal Complication

Intervention / Treatment
-----------------
* Procedure: appendectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women aged 18-45 years submitted to appendectomy for acute appendicitis during pregnancy or within the first six weeks after delivery were included. - Exclusion Criteria: Cases with missing data were excluded. -

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| In pregnancy<br>Appendectomy in pregnancy (n=12) | Procedure: appendectomy<br>* appendectomy performance<br>|
| In postpartum<br>Appendectomy in postpartum first six week (n=20) | Procedure: appendectomy<br>* appendectomy performance<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| delivery type | vaginal birth, cesarean section | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Newborn weight | kg | 5 years |
Predictive Objective Parameters for Outcome of the Treatment of Stress Urinary Incontinence

Study Overview
=================
Brief Summary
-----------------
To investigate the role of preoperative maximum urethral closure pressure and Valsalva leak point pressure in predicting outcome in patients who underwent trans-obturator tape for the treatment of female stress urinary incontinence.

Detailed Description
-----------------
A prospective observational descriptive study conducted from May 2002 to November 2005 at a single tertiary urban teaching University Uro-gynecological Department. 65 patients affected by stress or mixed urinary incontinence (stress component clinically predominant), defined according to International Continence Society guidelines, associated or not with urethral hypermobility underwent surgery which consisted of a fusion-welded, non-woven, non-knitted polypropylene tape (Obtape® Mentor-Porges). Preoperative MUCP and VLPP, stratified as ≤ or > 40 cmH20 and ≤ or > 60 cmH2O respectively, were separately or in combination correlated with primary (continence status: dry or wet) and secondary outcome variables (QoL questionnaires).

Official Title
-----------------
Preoperative MUCP and VLPP Failed to Predict Long Term (4-Years) Outcome in Patients Who Underwent Transobturator Mid-Urethral Slings. a Prospective Observational Descriptive Study

Conditions
-----------------
Urinary Incontinence

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mixed urinary incontinence (stress component clinically predominant) Exclusion Criteria: > grade II uro-genital prolapse in any vaginal compartment Previous incontinence surgery Urine retention, neurogenic bladder, benign or malignant uterus lesion (leiomyoma, fibromyoma, cervical or endometrial carcinoma) Active pelvic inflammatory disease Known hypersensitivity to synthetic materials (polypropylene, polythetrafloroethilene, polyethileneterephtalate, polyglactil acid or polyglycolic acid) Pregnancy or lactation; AND Any condition that in the judgment of the investigators would interfere with the subject's ability to provide informed consent, comply with study instructions, place the subject at increased risk, or which might confound interpretation of study results.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| A<br>Patients suffering from stress or mixed urinary incontinence | |

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
-----------------
Stress urinary incontinence, Mixed urinary incontinence, surgery, trans obturator tape, Maximum urethral closure pressure, Valsalva leak point pressure, outcome
Study Evaluating Bazedoxifene/Conjugated Estrogen Combinations in Vasomotor Symptoms Associated With Menopause

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether Bazedoxifine/conjugated estrogens are effective in the treatment of vaginal atrophy.

Official Title
-----------------
A Double-Blind, Randomized, Placebo-and Active-Controlled Efficacy and Safety Study of Bazedoxifene/Conjugated Estrogens Combinations for Treatment of Moderate to Severe Vulvar/Vaginal Atrophy in Postmenopausal Women

Conditions
-----------------
Vaginal Atrophy

Intervention / Treatment
-----------------
* Drug: Bazedoxifene/Conjugated Estrogen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Generally healthy, postmenopausal women, aged 40 to 65 years Intact uterus At least 1 moderate to severe vulvar/vaginal symptom that is most bothersome Exclusion Criteria: Hypersensitivity to estrogens, endometrial hyperplasia, known or suspected estrogen-dependent neoplasia Thrombophlebitis, thrombosis or thromboembolic disorders Neuro-ocular disease

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Bazedoxifene/Conjugated Estrogen|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Superficial cells (by cervical/vaginal cytologic smear) at screening, and weeks 4 and 12. |  |  | 
| Parabasal cells (by cervical/vaginal cytologic smear) at screening, and weeks 4 and 12. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaginal pH at screening, and weeks 4 and 12. |  |  | 
| Most bothersome moderate or severe vulvar/vaginal atrophy sympton at screening, and weeks 4 and 12. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vaginal Atrophy, Postmenopause
Post Market Clinical Follow-Up of Acetabular Titan-Augment Structan®

Study Overview
=================
Brief Summary
-----------------
Implant Survival as well as clinical and radiological Follow-Up of acetabular Titan-Augment Structan®

Official Title
-----------------
Post Market Clinical Follow-Up of Acetabular Titan-Augment Structan®

Conditions
-----------------
Total Hip Arthroplasty Revision

Intervention / Treatment
-----------------
* Device: Structan®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Minimum age 18 years Indication for cementless hip arthroplasty with acetabular defects that need Allograft or titanium augment Patient consent for study participation Physical and mental willingness to participate in the follow-ups Exclusion Criteria: Patient not available for follow-up Increased anesthetics risks for the patient according to the American Society of Anesthesiology: ASA IV Tumor Alcohol- or Drug abuse Permanent cortisone therapy Clinically relevant infection (Planned) pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Structan®<br> | Device: Structan®<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant Survival Rates | Implant survival is analysed at follow-up examinations at 3 and 12 months | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Outcome | Harris Hip Score | 3 and 12 months | 
| Pain | Visual Analogue Scale (VAS) | 3 and 12 months | 
| Osteolysis | Radiographic Outcome | 3 and 12 months | 
| Ossifications | Radiographic Outcome | 3 and 12 months | 
| Implant Position | Radiographic Outcome | 3 and 12 months | 
| Migration of Structan® | Radiographic Outcome | 3 and 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
THA, augment, revision, pelvis
Reiterative Development and Evaluation Study of OSA Therapy System

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate new iterations/generations of the ApniCure sleep therapy device.

Official Title
-----------------
A Multicenter, Prospective, Variable Duration, Reiterative Development and Evaluation Study of ApniCure's Therapy System(s) for the Treatment of Obstructive Sleep Apnea (OSA)

Conditions
-----------------
Obstructive Sleep Apnea

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is between the ages of 18 and 80. Subject is fluent in English and understands the Study protocol and is willing and able to comply with Study requirements and sign the informed consent form. Subject has a least one molar in each of the four quadrants of the mouth (right upper, right lower, left upper, and left lower). Exclusion Criteria: Poor nasal patency as evidenced by the inability to breathe through the nose with the mouth closed. Oral cavity infection or any other oral or dental condition or problem that would limit subject use of the ApniCure System (e.g. dentures, loose tooth/teeth, temporomandibular joint (TMJ) conditions, or any oral or dental condition that the Investigator believes could be exacerbated by the Attune Sleep Apnea System. History of any OSA surgical treatment including uvulopalatopharyngoplasty surgery (UPPP), maxillomandibular advancement surgery (MMA), radio frequency (RF) ablation treatment, palatal stent devices, etc. Any concomitant diagnosed or suspected sleep or chronic neurological disorders, other than OSA, including insomnia, and central sleep apnea. Currently working nights, or rotating night shifts. Current disease state, use of medication or other treatment which, in the investigator's opinion, may pose additional risk to the subject or confound the results of the study. Female subjects of child bearing age who are pregnant or intend to become pregnant during the study period.

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| OSA patients<br>Patients with Obstructive Sleep Apnea (OSA), or suspected OSA | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Ramadan and Energy Expenditure Study

Study Overview
=================
Brief Summary
-----------------
Ramadan fasting entails abstinence from eating and drinking between dawn and sunset. During this month major changes in meal times and patterns, sleeping times and activity occur. Starvation is known to lead to a compensatory reduction in energy expenditure. However, the Ramadan fast is not synonymous with starvation as it involves intermittent periods of fasting followed by gorging. People who fast during Ramadan feel less energetic. However, little is known about the effects of this religious practice on energy metabolism. . The aim of this study is to assess energy dynamics before and/or after and during Ramadan fasting in non-obese participants. Resting metabolic rate (RMR), thermic effect of food (TEF), active energy expenditure (AEE) and total energy expenditure (TEE) in free-living conditions will be measured . Indirect calorimetry will be used to assess RMR and TEF, doubly labeled water will be used to measure TEE and activity monitors will measure physical activity. In addition, body composition analysis will be performed by bio-electrical impedance. Blood sample will be taken to exclude medical factors affecting energy metabolism.

Official Title
-----------------
Ramadan and Energy (RAMEE) Study

Conditions
-----------------
Energy Expenditure During Ramadan Fasting

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Willing to participate. Age (18-70) years. BMI (20-30 kg/m2). Physically and mentally healthy. Consent form signed. Exclusion Criteria: Any patients with significant health problem. Pregnant and lactating females. Smokers. Consumption of caffeine before tests. Patients who have had vigorous exercise for the last 12 hours before visit. Patients with diabetes treated with drugs known to alter the metabolic rate. Patients who had bariatric surgery. Patients with eating disorders. Patients with conditions known to affect energy expenditure Patients on medication know to alter EE (Thyroxine, anti-thyroid drugs, certain cold remedies)

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Non diabetic, non obese<br> | |
| Non diabetic obese<br> | |
| Diabetic<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resting metabolic rate |  | 3 months | 
| 24 hour energy expenditure |  | 3 months |
Barriers to Adherence to Asthma Controller Meds in Low Income Urban Minority Adolescents

Study Overview
=================
Brief Summary
-----------------
Poor adherence to appropriate asthma medications is an important risk factor contributing to high asthma morbidity and mortality in urban African American adolescents. As part of the ADEPT (Adolescent Disease Empowerment and Persistency Technology) for Asthma Pilot 2 study, a focus group was developed specifically to explore existing barriers to adherence among inner city African American adolescent asthmatics.

Official Title
-----------------
Qualitative Analysis of the Barriers to Adherence With Asthma Controller Medication Among Inner City African American Adolescents as Identified Through Focus Group Data

Conditions
-----------------
Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 12-18 years of age self identify as African American have persistent asthma read at a minimum fourth grade reading level be on a prescribed daily inhaled corticosteroid medication for asthma Exclusion Criteria: candidate refusal or presence of other co-morbidities

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 15 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 |
| --- | --- |
| Barriers, Adherence, Asthma<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Focus groups explored whether a new communication medium improved adherence to asthma controller medications and to examine existing barriers to adherence among four urban African American adolescents with uncontrolled moderate persistent asthma |  |  |
Fabry Disease Screening in ESRD Patients in West of France

Study Overview
=================
Brief Summary
-----------------
Screening of Fabry disease in end-stage renal disease (ESRD) patients on dialysis or transplant in west of France.

Detailed Description
-----------------
Detection of Fabry disease is done by dried blood spot test, in dialyzed and transplanted men, who reached ESRD for vascular or unknown disease and were not previously screened.

Official Title
-----------------
Fabry Disease Prevalence in End-stage Renal Disease (ESRD) Patients on Dialysis or Transplant in West of France

Conditions
-----------------
ESRD

Intervention / Treatment
-----------------
* Other: Dried blood spot test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men less than 70 years old ESRD treated by dialysis or kidney graft in one of the 4 following regions : Bretagne, Centre, Pays de la Loire and Poitou-Charentes For unknown nephropathy OR vascular nephropathy and/or diabetic nephropathy unproved by biopsy Agreeing freely to participate in the study Exclusion Criteria: Men less than 18 years old Persons subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Men with ESRD on dialysis or transplant<br> | Other: Dried blood spot test<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To detect Fabry disease by dried blood spot test, in dialyzed and transplanted men, who reached ESRD for vascular or unknown disease and were not previously screened |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ESRD, Fabry disease
Psychometric Properties of the Chinese Version of the Five-item Relationship Satisfaction Scale

Study Overview
=================
Brief Summary
-----------------
The aims of this study are to translate the five-item relationship satisfaction scale（RS5) into Chinese and assess its psychometric properties among Chinese patients.

Detailed Description
-----------------
This study will use forward translation, reverse translation, and comprehensive methods to translate the RS5 scale into Chinese ,which will be more in line with the Chinese language and cultural environment. This study will also verify its reliability and validity in a large sample population to form a formal version of the scale. The scale will provide an effective tool for evaluating the degree of relationship satisfaction in China.

Official Title
-----------------
Psychometric Properties of the Chinese Version of the Five-item Relationship Satisfaction Scale

Conditions
-----------------
Relationship, Family

Intervention / Treatment
-----------------
* Other: Questionnaires set


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥18 years old; Participants who are married or in a romantic relationship; Be able to read and communicate in Chinese. Exclusion Criteria: Those who are unable to communicate due to serious mental or physical illnesses such as deafness, confusion caused by mental illness, etc.

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 |
| --- | --- |
| Questionnaires assessed partners<br>≥18 years old; Participants who are married or in a romantic relationship; Be able to read and communicate in Chinese. | Other: Questionnaires set<br>* Participants will be asked to respond to the demographic information sheet and the five-item relationship satisfaction scale(RS5) .<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationship satisfaction | The five-item relationship satisfaction scale（RS5）is a validated self-reported instrument assessing e-cigarette dependence.It consists of five items which are rated on a 6-point Likert scale (1 = Strongly disagree, 6 = Strongly agree). | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Factor Analysis, Statistical, Psychometrics / methods, Family Relations / psychology*