linjc16/ctgov huggingface dataset:
Water and the Gastropressor Response - Diurnal Variability

Study Overview
=================
Brief Summary
-----------------
We will test the null hypothesis that there is no diurnal (morning to afternoon)variability in the blood pressure response to the ingestion of water 16 oz.

Official Title
-----------------
Water and the Gastropressor Response - Diurnal Variability (Specific Aim 1.3)

Conditions
-----------------
Orthostatic Hypotension

Intervention / Treatment
-----------------
* Other: water 16 fl oz


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: orthostatic intolerance Exclusion Criteria: pregnancy

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>water 16 oz | Other: water 16 fl oz<br>* water 16 fl oz in AM and repeat in late afternoon<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood pressure |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| heart rate |  | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
water, orthostatic hypotension, blood pressure
Effects Of Repeat Inhaled Doses Of GW597901X On Patient Safety And Lung Function In Asthmatic Subjects

Study Overview
=================
Brief Summary
-----------------
This study is designed to look at the safety aspects and effects of repeat inhaled doses of GW597901X in asthmatics to develop this drug for its use in asthma and Chronic Obstructive Pulmonary Disease(COPD).

Official Title
-----------------
A Randomised, Double-Blind, Placebo-Controlled, Dose Ascending, 4 Period Crossover Study to Examine the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Repeat Inhaled Doses of GW597901X in Asthmatic Subjects

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

Intervention / Treatment
-----------------
* Drug: GW597901X


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Subjects with mild to moderate stable asthma but no other lung problems. Male subjects or female subjects who are not able to get pregnant (e.g. post-menopausal or surgically sterile). Non-Smokers. Subjects who show a measurable improvement in the function of their lungs after a single dose of salbutamol. Exclusion criteria: Any significant illness. Subjects with heart problems. Subjects who have a cold or chest infection 2-4 weeks prior to the study or have life-threatening asthma. Subjects who take medication for their asthma, or other conditions, not compatible with this study. Subjects who are over sensitive to salbutamol or to ipratropium.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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

| Intervention/Treatment |
| --- |
|Drug: GW597901X|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Tolerability including blood test results, effects on the heart, pulse rate and blood pressure, and any side effects. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects on the lungs at 12 and 24 hours Effects on the heart, blood pressure and heart rate at 8 hours Effects on blood tests over 4 hours and 8 hours Reduction of rescue medication. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GW597901X, Asthma, Crossover, dose ascending, repeat dose, inhaled
Correlation Between Electromyography and Thickness Change of the Trunk Muscles in Subjects With Low Back Pain

Study Overview
=================
Brief Summary
-----------------
Transversus abdominis (TrA) and lumbar multifidus (LM) muscle have been proposed to play key role in stability of the lumbosacral spine. The muscles' functional and/or structural deficits have been linked to the low back pain (LBP) syndrome. Evaluation of the transversus abdominis and lumbar multifidus muscles' function in clinical practice is scarce and not well defined due to number of reasons. Surface electromyography of TrA and LM muscles, as a method of examining muscles function, is not involved in clinical routine. Rehabilitative Ultrasound Imaging (RUSI) of the TrA and LM, apart from providing information about their morphology, could be helpful in assessing their function. Since concentric muscle contraction results in the shortening and thickening of the muscle, evaluation of the potential association between muscle's morphometry, assessed by the ultrasound, and electromyography, may be of potential clinical interest. However, this potential relationship is context-dependant. Our aim was to establish the difference in the thickness change of the TrA and LM muscle during activation in subjects with and without low back pain, and to establish the possible correlation between electromyography and the thickness change of these muscles assessed by ultrasound in both groups of subjects.

Conditions
-----------------
Low Back Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Low back pain, with or without radiculopathy, that lasted for at least 12 weeks, caused by prolapsed intervertebral disc (PID), confirmed by magnetic resonance imaging (MRI) Exclusion Criteria: The exclusion criteria for all participants were pregnancy,diabetes mellitus,corticosteroids administrated in one months or less prior to enrollment, spinal fractures, surgery, infectious diseases, tumors, spina bifida, advanced forms of spinal deformity, hip diseases, and neuromuscular disorders. Additional exclusion criteria for LBP participants were self-reported pain levels of less than 3 on the Visual Analog Scale to account for patients commonly encountered in clinical practice, and inability to remain in prone and supine hook-lying positions for 10 minutes each in order to ensure compliance.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| LBP<br>group of subjects with low back pain | |
| nonLBP<br>group without low back pain | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| thickness of the lumbar multifidus and transversus abdominis muscle |  | 1 day |
Assessment of the Safety and Efficacy of Ciproxan-I.V. in Daily Clinical Practice - Analysis Results From a Post-marketing Surveillance

Study Overview
=================
Brief Summary
-----------------
This study is a post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Ciproxan intravenously as a first-line treatment for sepsis, secondary skin infections followed by superficial burn, post-surgical or post-traumatic, pneumonia, peritonitis, cholecystitis, cholangitis, anthrax. The objective of this study is to assess safety and efficacy of Ciproxan in daily clinical practice. A total of 3,000 patients are to be enrolled and assessed during the period of treatment with Ciproxan.

Official Title
-----------------
Assessment of the Safety and Efficacy of Ciproxan-I.V. in Daily Clinical Practice - Analysis Results From a Post-marketing Surveillance

Conditions
-----------------
Infection

Intervention / Treatment
-----------------
* Drug: Ciprofloxacin (BAYQ3939)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who received Ciproxan as a first-line treatment were eligible for the study, among those with sepsis, secondary infection due to trauma, burn, or surgical wound, pneumonia, peritonitis, cholecystitis, cholangitis, and anthrax as the indications of this drug. Exclusion Criteria: Patients who are contraindicated based on the product label.

Ages Eligible for Study
-----------------
Minimum Age: 7 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 |
| --- | --- |
| Group 1<br> | Drug: Ciprofloxacin (BAYQ3939)<br>* Patient treated with Ciproxan as a first line treatment in daily clinical practice<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse drug reactions (ADRs) and serious adverse events (AEs) |  | After 9 days | 
| Clinical efficacy by four grade (Response, Minor Response, No Response, and Indeterminable) at an investigator discretion |  | After 9 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADR incidence rates classified by patient's background factors |  | After 9 days | 
| Efficacy rate calculated with Response and Minor Response considered as responder |  | After 9 days | 
| Efficacy rates classified by patient's background factors |  | After 9 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sepsis, Ciprofloxacin, infection, pneumonia, peritonitis, cholecystitis, cholangitis, anthrax
Hepcidin in Anemic Chronic Heart Failure (CHF) Patients

Study Overview
=================
Brief Summary
-----------------
Background: Anemia in chronic heart failure (CHF) is directly linked to increased mortality and reduced exercise capacity. The pathomechanism for the development of anemia in CHF is not well understood. Impairment of iron homeostasis is discussed to be one of the major triggers in anemia of chronic disease. Hepcidin was recently described as the central regulator of iron homeostasis. Main hypothesis: Plasma hepcidin levels are altered in anemic CHF patients compared to non anemic controls and might be a main contributing factor of anemia in CHF. Iron regulator-hypothesis High levels of cytokines in CHF patients cause up-regulation of hepcidin, which in turn leads to low iron uptake causing anemia. In this case venous hepcidin and hemoglobin concentrations should both correlate with cytokine levels. Erythropoietin regulator-hypothesis Dysregulation of the erythropoietin system results in anemia, which represses hepcidin. This leads to a negative correlation between hemoglobin and hepcidin in plasma. Methods: 100 consecutive patients diagnosed with systolic CHF will be prospectively included in the study. Iron status will be assessed and hepcidin, erythropoietin as well as interleukin-1, interleukin-6 and soluble TNF alpha receptor levels will be measured by ELISA. Patients will be followed up for one year and mortality, rehospitalization and worsening of CHF will be documented.

Official Title
-----------------
Hepcidin in the Pathogenesis of Anemia in Patients With Chronic Heart Failure

Conditions
-----------------
Anemia, Chronic Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Systolic left ventricular dysfunction (LVEF<45%) Signed informed consent Exclusion Criteria: Women of child bearing potential Pregnancy Non cardiac illness limiting life expectancy to <1 year Renal disease of non-cardiac reason Malignancy Chronic inflammatory disease Acute infection Erythropoietin therapy or iron substitution within the last 6 months

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemodilution |  |  |
Safety and Pharmacokinetics Study of Multiple Ascending Doses of BTA-C585 in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This is a single center, sequential-cohort, double-blind, placebo-controlled, multiple ascending dose (MAD), 7-day treatment period study in healthy subjects.

Official Title
-----------------
A Sequential-Cohort, Double-Blind, Placebo-Controlled, Multiple Ascending Oral Dose Study of the Safety and Pharmacokinetics of BTA-C585 in Healthy Volunteers

Conditions
-----------------
Pharmacokinetics, Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: BTA-C585 oral capsules
* Drug: BTA-C585 matching placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy men and women; Age 18 to 60 years, inclusive; Weight ≥ 50 kg and Body Mass Index (BMI) of 19 to 32, inclusive; Female subjects must be of non-childbearing potential; Male subjects must agree to use a double barrier method of birth control; Signed informed consent form (ICF) prior to study procedures. Exclusion Criteria: Current or recent (within 14 days of Day 0) bacterial or viral infection; Positive results at screening for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody; Clinically significant abnormalities noted on ECG; Safety laboratory abnormalities; Regular use of medications, prescription or non-prescription; Poor vein access or fear of venipuncture or sight of blood; Major surgery, significant recent injury or trauma within 30 days; Received an investigational drug or vaccine within 30 days.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BTA-C585 oral capsules<br>100 mg capsules; Multiple ascending doses (MAD) from 100 mg to 600 mg | Drug: BTA-C585 oral capsules<br>* BTA-C585; Multiple ascending doses from 100 mg to 600 mg<br>* Other names: BTA585;|
| Placebo Comparator: BTA-C585 matching placebo<br>BTA-C585 Matching placebo capsules; single doses | Drug: BTA-C585 matching placebo<br>* Multiple ascending doses to match 100 mg to 600 mg BTA-C585 capsules<br>* Other names: BTA585;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma concentration-time curve (AUC) from time 0 to 24 hours |  | 0-24 hours | 
| Number of adverse events |  | Day -1 to Day 14 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Viral Diseases, Antiviral, Paramyxoviridae Infections, RSV, Respiratory Syncytial Virus, Aviragen Therapeutics, Inc., Aviragen Therapeutics, Aviragen
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Anxiety

Study Overview
=================
Brief Summary
-----------------
This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.

Detailed Description
-----------------
The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to infection with anxiety

Official Title
-----------------
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Anxiety

Conditions
-----------------
Anxiety, Anxiety Disorders, Anxiety Depression

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study a. May be signed by parent or legal guardian in the case of minor or adult unable to provide consent Male or female of all ages Diagnosis of anxiety based on DSM-V criteria Exclusion Criteria: Refusal to sign informed consent form History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy. Postoperative stoma, ostomy, or ileoanal pouch Participation in any experimental drug protocol within the past 12 weeks Treatment with total parenteral nutrition

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 |
| --- | --- |
| Anxiety<br>Patients with anxiety | Other: No Intervention<br>* There is no intervention for this study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing | Relative abundance of bacterial classes within taxonomic phyla and, more broadly, within their domain will be analyzed by sequencing the gut microbiome. These data will then be categorized with anxiety | Three years |
A Phase II Study of Continuous Versus Syncopated Dosing of CC-5013 for the Treatment of Refractory Multiple Myeloma

Study Overview
=================
Brief Summary
-----------------
To evaluate the response rate, response duration, and survival of patients treated with CC-5013 in a chronic dosing schedule versus a syncopated dosing schedule.

Official Title
-----------------
A Phase II Study of Continuous Versus Syncopated Dosing of CC-5013 for the Treatment of Refractory Multiple Myeloma

Conditions
-----------------
Multiple Myeloma

Intervention / Treatment
-----------------
* Drug: CC-5013


Participation Criteria
=================
Eligibility Criteria
-----------------
History of histologically documented multiple myeloma with relapsed or resistant disease Pregnant or nursing women may not participate. Women of childbearing potential must have a negative pregnancy documented within one week of registration. Women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method. Signed written informed consent and willingness to meet follow-up schedule and study procedure obligations

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: CC-5013|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
-----------------
Multiple Myeloma, Revimid, CC5013, CC-5013
Knowledge Attitudes Beliefs and Practices Relative to HIV Among Sex Workers in French Guiana

Study Overview
=================
Brief Summary
-----------------
The aim was to determine the knowledge attitudes, beliefs, and practices regarding HIV in a population of sex workers in French Guiana and in the Brazilian border town of Oiapoque. A standardized questionnaire was administered face to face to sex workers. Analysis of the questionnaires led to descriptive statistics. Multiple logistic regression models were computed to determine the predictors of condom use.

Conditions
-----------------
HIV

Intervention / Treatment
-----------------
* Other: observational


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: sex worker Exclusion Criteria: not wishing to participate
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: observational|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| knowledge attitudes practices regarding HIV and sexually transmitted diseases | a structured questionnaire was used. it was administered face to face with usually 5 possible responses. Scores were established using similar questions exploring related areas of HIV. | when the interview was conducted |
Topical Cyclosporine and Disease Progression

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effect Restasis has in regards to disease progression.

Official Title
-----------------
Topical Cyclosporine and Disease Progression

Conditions
-----------------
Disease Progression, Disease Severity, Staining, Schirmers, OSDI

Intervention / Treatment
-----------------
* Drug: Restasis
* Drug: Endura


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mild to Moderate dry eye symptoms Exclusion Criteria: Current use of Restasis

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1.<br> | Drug: Restasis<br>* Restasis- (in the eye) Instill one drop twice daily Endura- (in the eye) Instill one drop twice daily<br>|
| Placebo Comparator: 2.<br> | Drug: Endura<br>* Restasis- (in the eye) Instill one drop twice daily Endura- (in the eye) Instill one drop twice daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Severity |  | 1 yr | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Staining |  | 1 yr |