linjc16/ctgov huggingface dataset:
Natural Cycle In Vitro Fertilization

Study Overview
=================
Brief Summary
-----------------
Natural IVF study patients will undergo an IVF cycle with trigger shots of Lupron & hCG. Patients will not be given any other stimulating medications during the cycle. They will have 2 uterine aspirations and an endometrial biopsy at designated times. The first uterine aspiration will be randomized to one of four days (day before retrieval, day of retrieval, day after retrieval or 2 days after retrieval). The second uterine aspiration and endometrial biopsy will be performed 6 days after retrieval. Any embryo(s) obtained will be biopsied for Comprehensive Chromosome Screening (CCS) and frozen for use in a subsequent thaw cycle.

Official Title
-----------------
Natural Cycle In Vitro Fertilization

Conditions
-----------------
Natural Cycle in Vitro Fertilization (IVF)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ovulatory cycles every 39 days or less (natural cycle IVF cannot be performed in someone who does not have cycles) Must be RMANJ patient and have completed all diagnostic screening at one of our RMANJ locations. All diagnostic screening is NOT covered under the study and must be completed prior to being allowed to start the study cycle. Exclusion Criteria: Prior enrollment/attempt in this study Requirement for surgical sperm extraction Inability to assess ovaries via transvaginal ultrasound Inability to tolerate vaginal examination

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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 |
| --- | --- |
| Natural IVF Cycle<br>All patients will undergo a natural IVF cycle using trigger shots of Leuprolide Acetate(Lupron) and human chorionic gonadotropin (hCG) to ensure the patient surges. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endometrial Changes | To examine the endometrium within the natural cycle in order to accurately characterize the differences in multiple aspects of endocrine and paracrine hormonal activity, the transcriptome of cells influencing oocyte maturation and changes in the endometrium. | 1 Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aneuploidy Rates | To examine aneuploidy rates in embryos from natural IVF cycles. | 1 Year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Natural, IVF Cycle
Biomarkers Serum Collection Methodology Pilot Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the standard collection of whole blood in tiger top tubes for serum collection versus a collection method of added FVIII to whole blood samples in the hemophilia population for routine biomarker assays to ensure reliable assay results.

Detailed Description
-----------------
20 adults with severe Hemophilia A seen in one HTC site for routine blood drawing will be consented for discard blood sampling. Half of the whole blood discard will be placed in a tiger top test tube, and half of the whole blood discard sample will be placed in a red top test tube containing exogenously added recombinant human FVIII concentrate [Advate, Baxter immuno] to assure an end concentration of once IU per CC of whole blood. Both whole blood specimens will be allowed to coagulate at room temperature and then will be centrifuged to prepare serum. The separated serum from each type of collection test tubes will be aliquoted into eppendorf tubes (a minimum of two aliquots per sample) at a volume of 150 microliters. Aliquoted serum samples will be stored at -70 degrees centigrade and shipped on dry ice to Synarc Labs. A panel of standard CTX bone resorption assays will be preformed in duplicate on the two differently processed serum specimens obtained from each subject. Results will be analyzed for inter-subject variability using stored age-matched samples provided by Synarc and intra-subject variability will also be analyzed.

Official Title
-----------------
Biomarkers Serum Collection Methodology Pilot Study

Conditions
-----------------
Hemophilia A

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Severe Hemophilia A Exclusion Criteria: If they are not diagnosed with severe hemophilia A.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Severe Hemophilia A, Hemophilia A Patients, Serum collection vs a method of added FVIII to blood samples
Enteral Nutrition in Liver Cirrhosis

Study Overview
=================
Brief Summary
-----------------
Malnutrition is frequently occurring in patients with liver cirrhosis and is associated with a poorer outcome, as it determines life quality and affects both morbidity and mortality. Long term prognosis after liver transplantation also depends on the nutritional status. Therefore, the early diagnosis and intervention for malnutrition is an important issue in the clinical management of liver cirrhosis. However, oral intake has been shown to be insufficient due to disease related anorexia or concomitant drowsiness and confusion. Specific aims: To investigate the effect of early nutritional intervention via tube feeding on nutritional status, functional status (hand grip strength and peak flow), life quality and disease related complications such as intestinal permeability, and oxidative stress, as well as liver function.

Conditions
-----------------
Liver Cirrhosis

Intervention / Treatment
-----------------
* Dietary Supplement: High Protein Energy, Fresenius-Kabi (nutritional intervention)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Liver cirrhosis (Child B or Child C) Exclusion Criteria: Malignant comorbidity Encephalopathy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: High Protein Energy, Fresenius-Kabi (nutritional intervention)|nan|

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
-----------------
liver cirrhosis Child B or C
A Sleep-Oriented Intervention for Suicidal Behaviors

Study Overview
=================
Brief Summary
-----------------
An open-label trial to investigate the use of a behavioral insomnia treatment for suicidal ideation.

Official Title
-----------------
A Sleep-Oriented Intervention for Suicidal Behaviors

Conditions
-----------------
Insomnia, Suicidal Ideation

Intervention / Treatment
-----------------
* Behavioral: Behavioral Insomnia Treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Age 18 or older Clinically significant sleep disturbances Diagnosis of depression

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behavioral Insomnia Treatment<br>Brief Behavioral Insomnia Treatment | Behavioral: Behavioral Insomnia Treatment<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Suicidal Ideation |  | Change from Baseline in Suicidal Ideation at 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Insomnia, Sleep, Behavioral Medicine, Suicide, Suicidal Ideation
A Clinical Pharmacology Study of TS-142 in Patients With Obstructive Sleep Apnea Hypopnea.

Study Overview
=================
Brief Summary
-----------------
A study to evaluate the respiratory safety of TS-142 in patients with mild obstructive sleep apnea hypopnea.

Official Title
-----------------
A Study to Evaluate the Respiratory Safety of TS-142 in Patients With Obstructive Sleep Apnea Hypopnea.

Conditions
-----------------
Patients With Mild Obstructive Sleep Apnea Hypopnea

Intervention / Treatment
-----------------
* Drug: TS-142
* Drug: Dose-matched Placebo to TS-142


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Japanese male and female, age 20 years or older at the time of informed consent Patients who meet the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) criteria for obstructive sleep apnea hypopnea Other protocol defined inclusion criteria could apply Exclusion Criteria: Subjects who meet any of the following criteria will be excluded from this study: Patients who meet the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) criteria excepting obstructive sleep apnea hypopnea and insomnia disorder Patients who have clinically significant respiratory dysfunction (bronchiectasis, emphysema, asthma, etc.) other than obstructive sleep apnea hypopnea Patients with percutaneous arterial oxygen saturation (SpO2) <94% by pulse oximetry at visit 1 Other protocol defined exclusion criteria could apply

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TS-142<br>Period in which subjects received TS-142 10 mg or The night when subjects received TS-142 | Drug: TS-142<br>* Subjects received single-dose of 10 mg of TS-142 (oral tablet)<br>|
| Experimental: Placebo<br>Period in which subjects received placebo or The night when subjects received matched placebo | Drug: Dose-matched Placebo to TS-142<br>* Subjects received single-dose matched placebo to TS-142 (oral tablet)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Least square mean difference of Apnea hypopnea index (AHI) from placebo | AHI is a number of apnea and hypopnea events per hour during sleep determined by polyso㎜ography (PSG). | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Least square mean difference of the mean SpO2 in total sleep time from placebo | The SpO2 will be simultaneously measured with PSG. The mean SpO2 during sleep determined by PSG will be calculated. | Day 1 |
Feasibility of the Modified Confusion Assessment Method for the Emergency Department (mCAM-ED)

Study Overview
=================
Brief Summary
-----------------
Delirium is common in older emergency department (ED) patients and often remains unrecognized. Existing instruments to detect delirium are often time consuming and therefore not feasible in the busy ED setting In this study the investigators tested the feasibility of the newly developed modified confusion assessment method (mCAM-ED).

Official Title
-----------------
Pilot Study on the Feasibility of the Modified Confusion Assessment Method for the Emergency Department (mCAM-ED)

Conditions
-----------------
Delirium

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients aged 65 or older Exclusion Criteria: patients treated in the resuscitation room patients transferred or discharged within 2 hours of arrival patients with insufficient proficiency in the German language patients with an inability to communicate (e.g. aphasic patients)

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- |
| pre-test group<br>All patients aged 65 or older presenting to the ED during the pre-test period | |
| post-test period<br>All patients aged 65 or older presenting to the ED in the post-test period | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| delirium | Delirium was assessed by research assistants using the mCAM-ED. Patients with a positive delirium diagnosis were presented to a senior emergency physician (PI) who served as the reference standard. The final delirium diagnosis was based on the DSM IV criteria | two hours after ED admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adherence of ED staff to mCAM-ED algorithm | Adherence was achieved when the mCAM-ED result was documented by the ED nurses. | At patient discharge or transfer from ED (average 4 hours after presentation) |
Evaluation of Postoperative Blood Pressure Changes After Benign Gynecologic Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to establish normal postoperative changes in blood pressure in women undergoing scheduled gynecologic surgery requiring inpatient postoperative care. Also, to establish if there is a difference in normal postoperative blood pressure changes between elderly and non-elderly women undergoing scheduled gynecologic surgery requiring inpatient postoperative care.

Official Title
-----------------
Evaluation of Postoperative Blood Pressure Changes After Benign Gynecologic Surgery

Conditions
-----------------
Urogynecology

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women who underwent scheduled gynecologic surgery requiring inpatient postoperative care between January 2007 - January 2008 Exclusion Criteria: Women who experienced myocardial infarction, cardiac arrest or failure, pulmonary embolism, infection requiring intravenous antibiotics, intra- or postoperative hemorrhage requiring blood transfusion, renal failure

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Underwent Gynecologic Surgery | 491 women were included in analysis. Measure is categorized by the type of surgery. | January 2007 to January 2008 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Women With Asymptomatic Hypotension | % women with asymptomatic hypotension | 1 year | 
| Percentage of Participants Undergoing Different Types of Anesthesia | Patients were given either general, regional or local-modified anesthesia care (LO-MAC). Some of the patients ended up getting both general and regional anesthesia (sometimes anesthesia team decides to add regional for postop pain control). | January 2007 to January 2008 | 
| Surgical Time | Length of surgery | January 2007 to January 2008 |
Study of IVC Filter Retrieval With the Günther Tulip Vena Cava Filter

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test the hypothesis that the Günther Tulip Vena Cava Filter can be removed after a period of implantation, when implanted in patients for the prevention of pulmonary thromboembolism.

Official Title
-----------------
A Non-Randomized Prospective Study of IVC Filter Retrieval

Conditions
-----------------
Pulmonary Embolism, Venous Thromboembolism

Intervention / Treatment
-----------------
* Device: Günther Tulip Vena Cava Filter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient must be considered at high risk for PE, but placement of a permanent IVC filter is not likely to be required. Patient must have a patent internal jugular vein. Patient has given informed consent. Exclusion Criteria: Patient is less than 18 years. Patient has a pre-existing filter Patient had indications for a permanent filter at the time of the initial evaluation. Patient has uncontrollable coagulopathy. Patient has a short life expectancy < 6 months. Patient has metastatic malignancy. Patient has a vena cava diameter over 30 mm, measured by vena cava sizing catheters. Patient has a contrast allergy that cannot be adequately pre-medicated. Patient is at risk of septic embolism. Patient has sepsis. Patient has a hypersensitivity to any of the components of the GT filter, specifically cobalt, nickel, and chromium. Patient has impaired renal function (creatinine > 2.0). Patient is pregnant or planning to become pregnant within the next 6 months

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

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Günther Tulip Vena Cava Filter|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of successful filter retrieval following implant. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of complications related to Inferior Vena Cava Filter use. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pulmonary Embolism, Venous Thromboembolism, Inferior Vena Cava Filter, IVC, PE
Quality of Life in Ventilator-dependant Neuromuscular Patients

Study Overview
=================
Brief Summary
-----------------
This study aims at evaluating the quality of life of patients with slowly progressive neuromuscular disorders who are dependant on mechanical ventilation (daily usage ≥ 16h).

Official Title
-----------------
Assessment of Quality of Life and Its Determinants in Ventilator-dependent Patients With Slowly Progressive Neuromuscular Disease

Conditions
-----------------
Tracheostomy, Quality of Life, Neuromuscular Diseases, Respiration, Artificial, Noninvasive Ventilation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with slowly progressive neuromuscular disorder (NMD), non walking Patients dependant on mechanical ventilation (daily usage ≥ 16h) for at least 1 year before inclusion Aged ≥ 18 yo Consent for participation Affiliated to a social security regime Exclusion Criteria: Patients with medically non-stable NMD: fever, acute respiratory infection, organ decompensation Patients with significant cognitive impairment (inability to read and/or incomprehension of questions) Patients with fast-evolving neuromuscular disease Patients declining to participate in the study Patients under guardianship and/or trusteeship Pregnant women

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score of the Severe Respiratory Insufficiency questionnaire (SRI) | Higher score represents better quality of life | 1 Day | 
| Score of the Quality of Life Measure for people with slowly progressive and genetic neuromuscular disease questionnaire (QoL-gNMD) | Higher score represents better quality of life | 1 Day |
Influence of Diet and Endurance Running on Intramuscular Lipids Measured at 4.1 TESLA

Study Overview
=================
Brief Summary
-----------------
The purpose of this pilot investigation is to use 1 H Magnetic Resonance Spectroscopy (MRS) to 1) document the change in intra-muscular lipid stores (IML) before and after a prolonged bout of endurance running and, 2) determine the pattern (time course) of IML replenishment following an extremely low-fat diet (10% of energy from fat) and a moderate-fat diet (35% of energy from fat). Specifically, the study will evaluate the change in IML following a 2-hour training run and the recovery of IML in response to the post-exercise low-fat or moderate-fat diet in 10 endurance trained athletes who will consume both diets in a randomly assigned cross-over fashion. We hypothesize that IML will be depleted with prolonged endurance exercise, and that replenishment of IML will be impaired by an extremely low-fat diet compared to a moderate-fat diet. Results of this pilot study will be used to apply for extramural grant support from NIH or the US Armed Forces to investigate the effect of dietary fat on the health and performance of individuals performing heavy physical training. It is anticipated that this methodology could also be employed in obesity research to delineate, longitudinally, the reported cross-sectional relationships among IML stores, insulin resistance and obesity.

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Procedure: magnetic resonance spectroscopy
* Drug: dietary fat


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers (developmental phase) Healthy endurance-trained subjects Maximum age for males is 39 Maximum age for females is 49

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 49 Years

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

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

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

Design Details

Primary Purpose: Treatment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: magnetic resonance spectroscopy|nan|
|Drug: dietary fat|nan|

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
-----------------
exercise, exertion, physical fitness, lipids, nutrition