linjc16/ctgov huggingface dataset:
Impact of Bariatric Surgery on Women Fertility

Study Overview
=================
Brief Summary
-----------------
Obesity is a multifactorial risk factor for subfertility, in relation to chronic hormonal change induced by adipose tissue. This prospective cohort study aims to evaluate the impact of bariatric surgery induced weight loss on women fertility.

Detailed Description
-----------------
Females undergoing sleeve gastrectomy will be assessed for improvement of fertility indicators

Official Title
-----------------
Impact of Bariatric Surgery Induced Weight Loss on Women Fertility: A Prospective Cohort Study

Conditions
-----------------
Fertility Issues

Intervention / Treatment
-----------------
* Procedure: Sleeve gastrectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age from 20-40 years. BMI >35 kg/m2 Exclusion Criteria: Women with medical endocrinal disorders as DM, thyroid, hyperprolactinaemia, etc. Women using any hormonal treatment or fertility drugs like oral contraceptive pills and/or metformin. Women have any surgical complication intra-operatively or post operatively. Women refused to participate in the study.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 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 |
| --- | --- |
| Sleeve gastrectomy<br>Sleeve gastrectomy for weight loss | Procedure: Sleeve gastrectomy<br>* Bariatric surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Antimullerian hormone level | Change in antimullerian hormone level | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in serum FSH level |  | 3 months | 
| Change in serum LH level |  | 3 months |
Oral Health and Psychosocial Factors During the Covid-19 Pandemic

Study Overview
=================
Brief Summary
-----------------
This prospective observational study examines the effects of the Covid-19 pandemic on oral health, taking psychosocial factors into account, and the possible impact of a high periodontitis risk on the severity of the need for treatment in Covid-19 patients.

Official Title
-----------------
Oral Health and Psychosocial Factors During the Covid-19 Pandemic

Conditions
-----------------
Covid-19, Periodontal Diseases, COVID

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥18 years old Residence in Germany Understanding of study participation and consent Exclusion Criteria: <18 years old Residence outside of Germany

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

| Intervention/Treatment |
| --- |
|Other: No intervention|questionnaire-based assessment|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| How do people assess their oral health-related quality of life in times of the Covid-19 pandemic? | The survey consists of validated and unvalidated items giving the opportunity to assess periodontitis risk, psychosocial stress, anxiety, depression and oral health related quality of life as well as questions focusing on experiences of the covid-19 pandemic. | 08.05.2020-31.07.2020 | 
| Does the periodontitis risk have an influence on the severety of the Covid-19 disease and its' treatment? | The survey consists of validated and unvalidated items giving the opportunity to assess periodontitis risk, psychosocial stress, anxiety, depression and oral health related quality of life as well as questions focusing on experiences of the covid-19 pandemic. | 08.05.2020-31.07.2020 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Do psychosocial stress factors in times of the Covid-19 pandemic have an impact on their oral health related quality of life? | The survey consists of validated and unvalidated items giving the opportunity to assess periodontitis risk, psychosocial stress, anxiety, depression and oral health related quality of life as well as questions focusing on experiences of the covid-19 pandemic. | 08.05.2020-31.07.2020 | 
| Have people changed their oral hygiene practices in times of the Covid-19 pandemic? | The survey consists of validated and unvalidated items giving the opportunity to assess periodontitis risk, psychosocial stress, anxiety, depression and oral health related quality of life as well as questions focusing on experiences of the covid-19 pandemic. | 08.05.2020-31.07.2020 |
Why Are so Many Patients Dissatisfied With Knee Replacement Surgery? Exploring Variations of the Patient Experience

Study Overview
=================
Brief Summary
-----------------
The goal of this research is to fill the knowledge gap relating to why up to 20 percent of total knee arthroplasty (TKA) patients are dissatisfied with their clinical outcomes and to answer the research question: What are the drivers of variation in the patient experience with primary (ie. not revision) TKA?

Detailed Description
-----------------
Purpose: Among patients with a diagnosis of osteoarthritis and who are undergoing total knee arthroplasty: To identify variations in the patient experience with primary knee replacement surgery by measuring clinical outcomes, health status, and patient satisfaction; and To explore the factors contributing to good/poor clinical and patient outcomes, such as surgical factors, health system factors, socioeconomic demographic factors and psychological factors.

Official Title
-----------------
Why Are so Many Patients Dissatisfied With Knee Replacement Surgery? Exploring Variations of the Patient Experience

Conditions
-----------------
Total Knee Arthroplasty

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults 19 and older Primary or secondary diagnosis of osteoarthritis or inflammatory arthritis Scheduled to undergo primary TKA Living in British Columbia Capable of providing informed consent Exclusion Criteria: Not having been diagnosed with osteoarthritis Inability to complete the study questionnaires Adults undergoing arthroplasty revision surgery Adults undergoing bilateral knee replacements Adults undergoing unicompartmental knee replacements Adults whose knee replacement is due to post-traumatic deformity Contacts and Locations

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Total knee arthroplasty
Follicular Versus Luteal Pipelle in Repeated Implantation Failure Patients

Study Overview
=================
Brief Summary
-----------------
Pipelle was found to increase pregnancy and implantation rates in women undergoing IVF treatment in general, and in particular in repeated implantation failure (RIF). However, there is virtually no data regarding the optimal timing for the pipelle. The current study aims to compare between follicular and luteal pipelle on pregnancy rate in RIF patients.

Conditions
-----------------
Repeated Implantation Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women diagnosed with RIF who are going to start a new IVF treatment Exclusion Criteria: Known hydrosalpinx body mass index (BMI) >29 kg/m2 or <18 kg/m2 Low ovarian response

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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 |
| --- | --- | --- |
| Pregnancy rate |  | April, 2014 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pipelle, luteal, follicular, implantation
A Trial Comparing Deep Versus Moderate Neuromuscular Block - in Low Pressure Pneumoperitoneum

Study Overview
=================
Brief Summary
-----------------
Live kidney transplantation is first choice for patients with end-stage kidney disease. Therefore, the safety and well-being of kidneys donors are highly important objectives in live kidney donation. Low pressure pneumoperitoneum can decrease postoperative pain and therefore also concomitant use of opioids.

Detailed Description
-----------------
However low pressure pneumoperitoneum can also decrease peri-operative conditions. In this trial the researchers will investigate whether peri-operative conditions during low pressure pneumoperitoneum can be optimized by the use of deep neuromuscular block.

Official Title
-----------------
A Randomized Controlled Trial Comparing Deep Versus Moderate Neuromuscular Block - in Low Pressure Pneumoperitoneum - to Optimize the Surgical Conditions During Laparoscopic Donor Nephrectomy

Conditions
-----------------
Nephrostomy; Complications, Pneumoperitoneum, Observation of Neuromuscular Block

Intervention / Treatment
-----------------
* Other: Deep neuromsucular block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: obtained informed consent age over 18 years Exclusion Criteria: chronic use of analgesics or psychotropic drugs use of non-steroidal anti-inflammatory drugs shorter than 5 days before surgery known or suspect allergy to rocuronium or sugammadex significant liver or renal dysfunction pregnant or breastfeeding

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Deep neuromsucular block<br>Deep neuromuscular block and low pressure pneumoperitoneum | Other: Deep neuromsucular block<br>* Deep or standard neuromuscular block<br>|
| No Intervention: Standard neuromuscular block<br>Standard neuromuscular block and low pressure pneumoperitoneum | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean surgical rating score |  | perioperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conversion to standard pressure pneumoperitoneum |  | perioperative | 
| Intra-operative complications |  | perioperative | 
| Length of pneumoperitoneum |  | perioperative |
A Post-Approval, Single-Arm Study of the SYNERGY Stent System in China

Study Overview
=================
Brief Summary
-----------------
A prospective, observational, single-arm, open-label, multicenter, post-approval study. To compile real-world clinical outcomes data for the SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGYTM Stent System) in real-world clinical practice in China.

Detailed Description
-----------------
This prospective, open-label, multi-center study is designed to provide post-market surveillance information on the SYNERGY Stent System. The study will evaluate clinical outcomes of subjects receiving the SYNERGY™ stents over 5 years in a real world setting according to post approval requirements by China government.

Official Title
-----------------
A Post-Approval, Single-Arm Study of the SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System in China

Conditions
-----------------
Cardiovascular Diseases

Intervention / Treatment
-----------------
* Device: SYNERGYTM Stent System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Subject must be at least 18 years of age Subject understands and provides written informed consent Subject who is clinically indicated and will have an attempt of at least one SYNERGYTM stent OR Subject who is clinically indicated and was implanted with at least one SYNERGYTM stent Subject is willing to comply with all protocol-required follow-up evaluation Exclusion Criteria: Exclusion criteria are not required in this study which is an all comers study.

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

| Intervention/Treatment |
| --- |
|Device: SYNERGYTM Stent System|no intervention design in the study|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACE rate | endpoints will be assessed post stent implant | 12 months |
Evaluation of CRB in PROM Patients

Study Overview
=================
Brief Summary
-----------------
The CRB study is designed to study the safety and effectiveness of the Cook Cervical Ripening Balloon (CRB) for the induction of labor in term and near-term patients with premature rupture of membranes (PROM).

Official Title
-----------------
Randomized Study to Compare the Cook Cervical Ripening Balloon (CRB) Plus Pitocin to Pitocin Alone in Premature Rupture of Membranes (PROM) Patients

Conditions
-----------------
Premature Rupture of Fetal Membranes

Intervention / Treatment
-----------------
* Device: CRB
* Drug: Pitocin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PROM not in labor Exclusion Criteria: Contraindication to vaginal delivery Contraindication to labor induction Abnormal fetal heart-rate patterns Maternal heart disease Severe maternal hypertension Pelvic structural abnormality

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

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

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 |
| --- | --- |
| Experimental: CRB plus Pitocin<br> | Device: CRB<br>* Labor induction using the CRB<br>Drug: Pitocin<br>* Labor induction using Pitocin<br>|
| Active Comparator: Pitocin<br> | Drug: Pitocin<br>* Labor induction using Pitocin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of Labor | Time, in minutes, from the start of labor induction through delivery | Start of labor induction through delivery, an expected average of 6 hours | 
| Incidence of Infection | number of patients with chorioamnionitis | Through hospital discharge, an expected average of 3 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Premature Rupture of Membrane (Pregnancy), PROM, Cervical Ripening, Induced Labor
PCV13 in Non-pregnant Papua New Guinean Women

Study Overview
=================
Brief Summary
-----------------
This is an observational study to determine the reactogenicity and immunogenicity of pneumococcal conjugate vaccine in non-pregnant women of reproductive age in Papua New Guinea.

Official Title
-----------------
Reactogenicity and Immunogenicity of Pneumococcal Conjugate Vaccination in Non-pregnant Papua New Guinean Women

Conditions
-----------------
Pneumococcal Infections

Intervention / Treatment
-----------------
* Biological: 13-valent pneumococcal conjugate vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Non-pregnant 18-45 years old Exclusion Criteria: Known hypersensitivity to any vaccine component Known/suspected to be immunocompromised Receipt of corticosteroids ≤30 days before Pregnant (pregnancy tests will be performed) Not being well at the time of vaccination Plan to travel out of the area in the month post-vaccination

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Women of childbearing age<br>Healthy non-pregnant women between 18 and 45 years old living in Goroka, Papua New Guinea, will receive one dose of 13-valent pneumococcal conjugate vaccine (PCV). | Biological: 13-valent pneumococcal conjugate vaccine<br> <br> * Other names: Prevenar13;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity | Mean Fold Increase (MFI; and 95% CI) in vaccine-serotype specific IgG concentrations at 28 days after compared to baseline (before vaccination) | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reactogenicity | Proportion (% & 95% CI) of participants with local and systemic side effects 24-48 hours after vaccination | 24-48 hours after vaccination | 
| Adverse events | Proportion (% & 95% CI) of participants reporting any unexpected adverse effect (AE) during 28 days after vaccination | 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pneumococcal conjugate vaccine, PCV, Reactogenicity, Immunogenicity, Women childbearing age
Hyperbaric Oxygen Treatment Ameliorates Insulin Resistance

Study Overview
=================
Brief Summary
-----------------
Obesity is an epidemic in Western society and is the biggest risk factor for insulin resistance and type 2 diabetes. The investigators have preliminary evidence showing that hyperbaric oxygen therapy rapidly increases insulin sensitivity in humans. This requires confirmation in a larger population, and with this study the investigators will also test for mechanisms how this occurs. The investigators suspect that modulation of hypoxia and stress response proteins following changes in tissue oxygenation may contribute to these improvements. This study has the potential to yield new and important insights into the insulin resistance in obesity.

Official Title
-----------------
Hyperbaric Oxygen Treatment Ameliorates Insulin Resistance

Conditions
-----------------
Obesity, Type 2 Diabetes

Intervention / Treatment
-----------------
* Procedure: Hyperbaric Oxygen Treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Obese men with and without type 2 diabetes aged 45-70 Lean men without type 2 diabetes aged 45-70 Exclusion Criteria: smokers claustrophobic sleep apnoea blood donor exercise more than 2 times per week under certain medications eg: bleomycin,corticosteroid

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Hyperbaric Oxygen Treatment|Participants will undergo 4 treatments of hyperbaric oxygen. Each treatment consists of 90 minutes compression at 2 atmospheres of pressure, with 30 minutes decompression back to 1 atmosphere, during this time, patients will be treated with 100% Oxygen delivered via a hood system.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin sensitivity | Using Hyperinsulinemic clamp | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypoxia and inflammatory markers | using IHC, qPCR, Western blot | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Insulin resistance, Inflammation, Hypoxia
Shoulder Training: Muscle Recruitment Patterns and the Effect of an Exercise Program

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the muscle recruitment pattern and the effect of a 6 week shoulder exercise training program in healthy persons and subjects with shoulder impingement

Official Title
-----------------
Shoulder Training: Muscle Recruitment Patterns and the Effect of an Exercise Program

Conditions
-----------------
Shoulder Impingement

Intervention / Treatment
-----------------
* Procedure: Exercise training program
* Procedure: Exercise training program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: current reported history of shoulder pain localised at the glenohumeral joint diagnosed as impingement two positive shoulder impingement tests pain reproduction during two of three additional categories of clinical tests the subject is able to perform pain-free arm elevations with a resistance of 0.5 kg Exclusion Criteria: cervical and periscapular pain positive labral injury tests history of shoulder surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Subject with shoulder impingement | Procedure: Exercise training program<br>* A 6 week shoulder exercise training program<br>|
| Active Comparator: 2<br>Healthy persons | Procedure: Exercise training program<br>* A 6 week shoulder exercise training program<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle recruitment pattern |  | After 6 weeks of training | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shoulder pain and functional ability in the patient group |  | After 6 weeks of training |