linjc16/ctgov huggingface dataset:
Factor V Leiden Mutation and Implantation Failure

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether inherited thrombophilias (tendency toward blood clotting) increase the risk of failure of the embryo to implant in IVF. The specific condition to be studied is the presence or absence of the Leiden mutation of the Factor V gene.

Official Title
-----------------
Evaluation of the Role of Factor V Leiden Mutation in Implantation Failure

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Procedure: Test for Factor V Leiden gene mutation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women undergoing in-vitro fertilization with successful ovarian hyperstimulation, oocyte retrieval, and fertilization Transfer of at least 2 fresh embryos of Grade 2 (preembryo with blastomeres of equal size and <=10% cytoplasmic fragmentation) or better Exclusion Criteria: Infertility due to uterine anatomic defect Current use of anticoagulant medication, such as heparin or aspirin Known presence of any other condition associated with increased risk of thrombosis

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Test for Factor V Leiden gene mutation|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
-----------------
Infertility, Factor V Leiden
ONO-7746 Study in Healthy Adult Subjects

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to evaluate the safety and tolerability of ONO-7746 in healthy adult subjects. The secondary objectives are to characterize the pharmacokinetic and pharmacodynamic profiles of ONO-7746.

Official Title
-----------------
A Double-Blind, Placebo-Controlled, SIngle Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ONO-7746 in Healthy Adult Subjects

Conditions
-----------------
Healthy Adult Subjects

Intervention / Treatment
-----------------
* Drug: ONO-7746
* Drug: ONO-7746


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy non-smoking male or female subjects (18-55 years inclusive) Body mass index (BMI) of 19-35 kg/m² (inclusive) For females: postmenopausal, non-lactating and non-pregnant Exclusion Criteria: History or presence of clinically significant disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: P<br> | Drug: ONO-7746<br>* 5mg, 10mg, 20mg, 50mg, 100mg, 200mg, 400mg, 800mg, 1200mg QD/1 day<br>|
| Experimental: E<br> | Drug: ONO-7746<br>* 5mg, 10mg, 20mg, 50mg, 100mg, 200mg, 400mg, 800mg, 1200mg QD/1 day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of ONO-7746 across ascending single doses |  | study duration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterization of PK and PD profiles of ONO-7746 |  | study duration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ONO-7746, Healthy adult subjects
Healthcare Provider Attitudes Towards Patients With Substance Use Before and After Implementation of the SBIRT Model in the Emergency Room

Study Overview
=================
Brief Summary
-----------------
The purpose of this quality improvement research project is to briefly survey attitudes among healthcare providers toward patients with substance use disorders before and after substance abuse counselors are placed in the Emergency Room.

Detailed Description
-----------------
The purpose of this quality improvement research project is to briefly survey attitudes among healthcare providers toward patients with substance use disorders before and after substance abuse counselors are placed in the Emergency Room. SBIRT stands for Screening Brief Intervention and Referral to Treatment. The pre-test survey contains 10 questions about attitudes toward patients with substance use disorders and the post-test survey consists of 13 questions about attitudes toward patients with substance use disorders and questions regarding the SBIRT model itself. Health care providers will be surveyed before the SBIRT Counselors begin and again at 6 months, after full SBIRT program with substance counselors on site has been in place, as a part of their regular staff education requirements. Part of the goal of the SBIRT counselors is to educate providers about treatment and analyze data collected by and comments of Emergency Room staff.

Official Title
-----------------
Healthcare Provider Attitudes Towards Patients With Substance Use Before and After Implementation of the SBIRT Model in the Emergency Room

Conditions
-----------------
Patients With Substance Abuse, Healthcare Provider Attitudes

Intervention / Treatment
-----------------
* Other: Training on motivational interviewing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: UAB Emergency Department Staff (attending, resident, nurse, social worker, case manager, patient care technician) or Psychiatry Emergency Services staff (nurses, social workers and residents) Exclusion Criteria: Not employed in UAB Emergency Department

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Emergency Department personnel<br>survey | Other: Training on motivational interviewing<br> <br> |
| Department of Psychiatry personnel<br>survey | Other: Training on motivational interviewing<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Post Market Registry Study of the AeriSeal System

Study Overview
=================
Brief Summary
-----------------
Obtain and analyze medical record data on patients with advanced emphysema who receive treatment with the AeriSeal System to better understand safety and effectiveness in the post-market setting; Provide participating physicians access to specified data sets for the purpose of generating scientific manuscripts about the effects of AeriSeal System treatment.

Official Title
-----------------
Post Market Registry Study of the AeriSeal System

Conditions
-----------------
Pulmonary Emphysema

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Advanced Emphysema AeriSeal System treatment Exclusion Criteria: have a primary diagnosis of asthma, chronic bronchitis or bronchiectasis have had frequent COPD exacerbations within the past year require mechanical ventilatory support have a pretreatment DLCO < 20% predicted or > 60% predicted have a pretreatment FEV1 < 20% predicted AND homogeneous emphysema have giant bullae have undergone lung transplantation, lung volume reduction surgery, or lobectomy are intolerant of corticosteroids or antibiotics are pregnant or breast-feeding

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- | --- |
| Post Market Registry Study of the AeriSeal System | -Obtain and analyze medical record data on patients with advanced emphysema who receive treatment with the AeriSeal System to better understand safety and effectiveness in the post-martet setting | At least 4 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Emphysema, GOLD Stage III, GOLD Stage IV, AeriSeal System, Homogeneous, Heterogeneous, Upper Lobe Predominant, ULP, Chronic Obstructive Pulmonary Disease, COPD, Lung Volume Reduction Surgery, LVRS, Bronchoscopic Lung Volume Reduction, BLVR
Effect of Acupuncture on Symptoms of Diarrhea and Pain in IBS

Study Overview
=================
Brief Summary
-----------------
Acupuncture has been used for centuries in China in the treatment of diarrhea. Our hypothesis is that acupuncture is effective in the treatment of abdominal pain and diarrhea in patients with diarrhea-predominant IBS

Detailed Description
-----------------
Patients will complete a diary to determine if they qualify for the study. Patients will be randomized to receive either acupuncture or sham acupuncture (needle insertion 1 cm away from acupuncture site). Patients will be blinded to whether they are receiving acupuncture or sham acupuncture. The acupuncturist is blinded as to the patient response. The patients will undergo venupuncture to draw blood to determine sertotonin and beta-endorphin levels. They will receive treatment in 12 sessions over 4 weeks. They will maintain a diary during this time period to document level of pain and frequency of bowel movements. Blood will be drawn at week 2 and 4 and, 6 weeks after cessation of treatment, subjects will again record abdominal symptoms and frequency of bowel movements for 2 weeks. Blood will be drawn for hormone levels at 8 weeks after completion of study.

Official Title
-----------------
Effect of Acupuncture on Symptoms of Diarrhea and Pain in Diarrhea Predominant Irritable Bowel Syndrome (IBS) and Effect on Plasma Beta-endorphin and Serotonin Levels.

Conditions
-----------------
Irritable Bowel Syndrome

Intervention / Treatment
-----------------
* Procedure: acupuncture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: frequence of bowel movement of at least 3/day global disease severity of at least 3 Exclusion Criteria: taking medications which will influence frequency of bowel movement patient taking anticoagulants or suffering from coagulopathy pregancy

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: acupuncture|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of bowel movement |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abdominal pain |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diarrhea-predominant irritable bowel syndrome, Acupuncture, abdominal pain
Sweat Gland Function in Patients With Failed Back Surgery Syndrome, Treated With Spinal Cord Stimulation

Study Overview
=================
Brief Summary
-----------------
This study is investigating sweat gland function during on and off states of the spinal cord stimulator, in patients with failed back surgery syndrome.

Official Title
-----------------
Sweat Gland Function in Patients With Failed Back Surgery Syndrome, Treated With Spinal Cord Stimulation

Conditions
-----------------
Failed Back Surgery Syndrome

Intervention / Treatment
-----------------
* Device: SCS is switched off
* Device: SCS is switched on


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is at least 18 years old. Diagnosis of FBSS (Failed conservative treatments for pain including but not limited to pharmacological therapy and physical therapy) and currently being treated with spinal cord stimulation. Cognitive and language functioning enabling coherent communication between the examiner and the participant. Exclusion Criteria: Patients with major psychiatric problems.

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: Basic Science
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SCS off<br>SCS is switched off | Device: SCS is switched off<br>* Spinal cord stimulator is switched off for 12 hours<br>|
| Experimental: SCS on<br>SCS is switched on | Device: SCS is switched on<br>* Spinal cord stimulator is functioning<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sweat gland function by measuring Electrochemical Skin Conductances (ESC) | The investigators will examine the difference in sweat gland function between both measurements (SCS on versus SCS off), measured with the Sudoscan. | The change between the measurement while SCS is switched off and while SCS is switched on. Total study duration lasts one day. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity scores using the Visual Analogue Scale | Pain intensity score on that time on a Visual Analogue Scale (VAS) from zero (no pain) towards 10 cm (worst possible pain) for the pain intensity. | Two times on the same day; once while SCS is switched off and once while SCS is switched on. Total study duration lasts one day. |
Estimating the Short-term Effectiveness of Online Advertisements for Improving Health

Study Overview
=================
Brief Summary
-----------------
Bing ads designed to encourage people to adopt healthier practices (e.g., stop smoking, become physically active, stop consuming harmful content) are shown using the advertising system, to test which ads are more effective as apparent in the subsequent queries to Bing submitted by users who saw the ads.

Official Title
-----------------
Estimating the Short-term Effectiveness of Online Advertisements for Improving Health

Conditions
-----------------
Anorexia, Obesity, Smoking Cessation

Intervention / Treatment
-----------------
* Behavioral: Ads display with target websites
* Behavioral: Ads display with control websites


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Use of the Bing ad system with target phrases. Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>People shown ads with referral to target websites. | Behavioral: Ads display with target websites<br>* Ads are shown, but users are referred to control websites.<br>|
| Active Comparator: Intervention with control websites<br>People shown ads with referral to control websites. | Behavioral: Ads display with control websites<br>* Ads are shown, but users are referred to control websites.<br>|
| No Intervention: Control<br>People who make target queries, but are not shown the ads. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of people who increase and the number of people who decrease searches for positive target behaviors post intervention, compared to prior to the intervention, or a similar decrease in negative behaviors | Increase or decrease in searches for positive target behaviors post intervention, compared to prior to the intervention, or a similar decrease in negative behaviors. This measure of outcome was previously used in E. Yom-Tov, Muennig & El-Sayed (2016). | Up to 1 month after the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clickthrough rates | Clickthrough rates on each ad | During the intervention itself and up to 1 minute after the intervention (advertisement display). |
Effect of Malnutrition on the Prognosis in Hemodialysis Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examined the effect of malnutrition and/or inflammation on atherosclerosis and prognosis in hemodialysis.

Detailed Description
-----------------
Malnutrition is known to affect their prognosis in hemodialysis patients. Furthermore, recent studies indicate that malnutrition is associated with inflammation and atherosclerosis in these patients. In this study we examine the effect of malnutrition and/or inflammation on atherosclerosis and 5-year survival rate in 600 hemodialysis patients.

Official Title
-----------------
Effect of Malnutrition on the Prognosis in Hemodialysis Patients

Conditions
-----------------
Chronic Renal Failure, Hemodialysis, Malnutrition

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hemodialysis for at least 6 months Exclusion Criteria: disabled patients

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 70 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 |
| --- | --- | --- |
Nexium Capsules S-CEI for Justification of Esomeprazole in Acid Related Disease for Reflux Symptom Healing Based on Patient Clinical Outcomes

Study Overview
=================
Brief Summary
-----------------
The objective of this investigation is to collect following data in patients given NEXIUM capsule (NEXIUM) in usual post-marketing use.

Detailed Description
-----------------
Primary objective To investigate treatment response to NEXIUM in patients with reflux esophagitis (RE). Secondary objectives To investigate following items in patients with RE: Patient satisfactory level of the treatment for RE Health-related quality of life (HRQOL) Severity and frequency of RE symptoms reported by physicians Endoscopic healing rate Development of ADRs

Official Title
-----------------
NEXIUM Capsule Specific Clinical Experience Investigation (S-CEI) to Investigate Treatment Response to NEXIUM in Patients With Reflux Esophagitis (RE) - Justification of Esomeprazole in Acid Related Disease for Reflux Symptom Healing Based on Patient Clinical Outcomes

Conditions
-----------------
Reflux Esophagitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients to be enrolled in this S-CEI must fulfill all the criteria below at the start of the treatment with NEXIUM. Aged at least 20 years. Patients who has a current or past history of clinically diagnosed RE Patients whose answers in the baseline GerdQ include 2-3 days or 4-7 days in at least one of the questions Nos 1, 2, 5 and 6. Patients to whom NEXIUM 20 mg once daily is to be administered for RE Patients from whom written consent has been obtained. Exclusion Criteria: Patients must not enter the investigation if any of the following exclusion criteria are fulfilled at the start of the treatment with NEXIUM: Patients whose ability to follow instructions are suspected to be low by physicians Patients with a past history of hypersensitivity to the ingredients of NEXIUM. Patients receiving atazanavir sulfate or rilpivirine hydrochloride Patients who have received NEXIUM within the past eight weeks for treatment of RE
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NEXIUM<br>Oral dose 20mg/day | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment response to NEXIUM based on answers in GerdQ | The rate of patients whose answers in the GerdQ are none or one day in the questions Nos 1, 2, 5 and 6 at the end of the observation. GerdQ is a questionnaire for assessment of symptoms. | at the time of Treatment Week 8 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
reflux esophagitis, Nexium
Fosamprenavir Expanded Access

Study Overview
=================
Brief Summary
-----------------
This open-label study will enable HIV-infected adults with limited treatment options to receive fosamprenavir until commercial supplies are available in Switzerland.

Official Title
-----------------
An Open-label Phase III Study to Provide Access to Fosamprenavir and to Assess the Long Term Safety and Tolerability of Fosamprenavir Containing Regimens in HIV Infected Patients With Limited Treatment Options

Conditions
-----------------
Infection, Human Immunodeficiency Virus

Intervention / Treatment
-----------------
* Drug: fosamprenavir
* Drug: Telzir®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV-1 infected subjects. Subjects must belong to one of the following populations: Subjects with limited treatment options due to viral resistance, interactions, or tolerability issues with other antiretroviral drugs. Subjects who already receive amprenavir (Agenerase®) Subjects for whom once daily dosing of antiretroviral therapy is indicated, including, once daily dosing with fosamprenavir/ritonavir.

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 |
| --- |
|Drug: fosamprenavir|nan|
|Drug: Telzir®|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
-----------------
protease inhibitor, Treatment Experienced, amprenavir, fosamprenavir, GW433908, HIV, pro drug