linjc16/ctgov huggingface dataset:
Calcium Intake, Metabolism, and Gestational Blood Pressure

Study Overview
=================
Brief Summary
-----------------
To determine if low dietary calcium intake and disturbances in maternal calcium metabolism were associated with increases in blood pressure in late pregnancy.

Detailed Description
-----------------
BACKGROUND: The importance of maintaining dietary calcium intake and normal calcium metabolism for optimal regulation of arterial blood pressure has been demonstrated in humans and animals. Recent reports have suggested that low dietary calcium intake and disturbances in maternal calcium metabolism are associated with increases in blood pressure in late gestation. These factors may be associated with an increased risk of developing pregnancy-induced hypertension. This study was conducted in response to a Request for Applications on Research on Hypertension in Pregnancy jointly released in 1986 by the National Heart, Lung, and Blood Institute and the National Institute of Child Health and Human Development. DESIGN NARRATIVE: Blood pressure, nutrient intake, and markers of calcium metabolism were prospectively assessed in normal, pregnant women. Nutrient intakes, including dietary calcium, were assessed during gestation weeks 24, 28, 32, 36, and the postpartum period using 3-day food records and 24-hour dietary recalls. Concomitantly, serum measures of calcium metabolism were assessed including serum total and ionized calcium, parathyroid hormone, calcitonin, vitamin D concentration, serum magnesium, phosphorus, sodium, and potassium concentrations. During weeks 24 and 32, urinary excretion of sodium, calcium, magnesium, potassium, phosphorus, cAMP, and creatinine were measured. Blood pressures were measured at every prenatal visit and postpartum. Measures of infant growth and blood pressure were assessed at 1, 6, and 12 months of age to determine if maternal dietary calcium intake exerted long-term influences on infant development and blood pressure. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

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

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 |
| --- | --- | --- |
Study of the Safety of Substituting Exenatide for Insulin in Patients Using Insulin and Oral Antidiabetic Agents

Study Overview
=================
Brief Summary
-----------------
This study will look at the safety of substituting exenatide for insulin in patients with type 2 diabetes who are currently taking insulin and oral antidiabetic agent(s).

Detailed Description
-----------------
This is an exploratory, multicenter, open-label, 2-arm, parallel trial. Approximately 30 patients with type 2 diabetes, currently on a sulfonylurea, or meglitinide and/or metformin and insulin therapy, will be randomized to discontinue insulin and substitute it with exenatide or remain on their current diabetes therapy regimen. All patients will continue their current diet and exercise regimen during the study.

Official Title
-----------------
An Exploratory Study of the Safety of Substituting Exenatide for Insulin in Patients With Type 2 Diabetes Who Have Been Using Insulin in Combination With Oral Antidiabetic Therapy

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: exenatide
* Drug: Insulin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients have been treated with insulin for >=3 months up to 12 years. HbA1c <=10.5%. Body mass index (BMI) between 27 kg/m2 and 40 kg/m2. Exclusion Criteria: Patients previously received exenatide or GLP-1 analogs. Patients have been treated for greater than 2 weeks with thiazolidinediones or alpha-glucosidase inhibitors within 3 months prior to screening.

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 70 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exenatide<br>The subjects will discontinue their insulin and substitute it with exenatide. Subjects will remain on their existing oral diabetic therapy. | Drug: exenatide<br>* Exenatide 5 mcg subcutaneously injected twice daily for 4 weeks; then 10 mcg subcutaneously injected twice daily for 12 weeks.<br>* Other names: Byetta;|
| Active Comparator: Insulin<br>The subjects will remain on their current insulin therapy. Subjects will also remain on their existing oral diabetic therapy. | Drug: Insulin<br>* Insulin will be taken according to the subject's current regimen<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 16 | Change in HbA1c from Baseline study termination (Week 16) | Baseline, Week 16 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
exenatide, exendin-4, Amylin, Eli Lilly, diabetes
Clinical Evaluation of the Safety and Performance of Microwave Coagulation Using the HS1 Instrument

Study Overview
=================
Brief Summary
-----------------
Clinical evaluation of the safety and performance of microwave coagulation using the HS1 Instrument for actual or potential non-variceal bleeding in the upper Gastrointestinal (GI) tract

Official Title
-----------------
Clinical Evaluation of the Safety and Performance of Microwave Coagulation Using the HS1 Instrument for Actual or Potential Non-variceal Bleeding in the Upper Gastrointestinal (GI) Tract

Conditions
-----------------
Actual or Potential Nonvariceal Bleeding in the Upper Gastrointestinal (GI) Tract

Intervention / Treatment
-----------------
* Device: Microwave coagulation using HS1 Instrument


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient or authorised representative able to comprehend and sign the Informed Consent form. Actual or potential non-variceal bleeding in the upper GI, including angiodysplasia or AVM malformations such as Dieulafoy's lesion with a Glasgow-Blatchford score of greater than 1 Exclusion Criteria: As stated in the contraindications in the HS1 IFU; Aged <18 years of age Those described as vulnerable populations in EN ISO 14155; Patients with a known coagulopathy (congenital); Concurrent participation in another experimental intervention or drug study Unwilling or unable to provide informed consent. A patient whose Glasgow-Blatchford score is 1 or less

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patients receiving microwave therapy using the HS1 Instrument<br> | Device: Microwave coagulation using HS1 Instrument<br>* Microwave therapy at 5.8 GHz<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effective coagulation of of actual or potential non-variceal bleeding in the upper Gastrointestinal (GI) tract. | Primary haemostasis at day 0 using microwave coagulation of active bleeding or pre-coagulation of exposed vessels. | Perioperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification and incidence of intra-procedural complications |  | Day 0 | 
| Identification and incidence of post-procedural complications |  | At 24-72 hours, 1 week and 4 weeks | 
| Change in Glasgow-Blatchford score | The Glasgow-Blatchford score will be recorded prior to and after microwave intervention | Day 0 for initial screen and then 24-72 hours post-procedure for second score. |
A Pilot Study to Explore the Role of Gut Flora in Celiac Disease

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

Detailed Description
-----------------
The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to the information provided in surveys and in medical records regarding Celiac Disease

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

Conditions
-----------------
Celiac Disease

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 Male or female patients of any age (interest is given to children to compare with mothers). Diagnosis of Celiac Disease 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 Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial Inability to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients<br>Patients who have been diagnosed with Celiac Disease | 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 Celiac 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 among specific disease types. | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation of Sequencing Methods | To validate the methods used to sequence samples | One year |
A Phase II Study of CODOX-M/ IVAC in Relapsed/Refractory ALL

Study Overview
=================
Brief Summary
-----------------
A Phase II Study of CODOX-M/ IVAC in Relapsed/Refractory ALL

Detailed Description
-----------------
The feasibility will be evaluated in terms of complete remission rate, duration of complete remission, disease-free survival, overall survival, and toxicities.

Official Title
-----------------
A Phase II Study of CODOX-M/ IVAC in Relapsed/Refractory ALL

Conditions
-----------------
Acute Lymphoblastic Leukemia

Intervention / Treatment
-----------------
* Drug: CODOX-M


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with relapsed/resistant acute lymphoblastic leukemia Patients must be between 15 and 65 years of age. Estimated life expectancy of more than 3 months ECOG performance status of 2 or lower, Karnofsky scale > 60 (see appendix I) Adequate cardiac function (EF>45%) on echocardiogram or MUGA scan Adequate kidney function (estimated Ccr >50 ml/min) Exclusion Criteria: Patients with CNS involvement of leukemic blasts will not be excluded. Patients with extramedullary relapse(s) only will be excluded.

Ages Eligible for Study
-----------------
Minimum Age: 15 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: CODOX-M|Cytoxan,Mesna,Adriamycin,Vincristine,Methotrexate,Leucovorin,Cytarabine|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of complete remission, disease-free survival, overall survival, toxicities |  | 2009 |
Study of the Use of Humidified Warmed Gas and the Effect on Post-Operative Pain in Laparoscopic Cholecystectomies

Study Overview
=================
Brief Summary
-----------------
Double blind RCT comparing elective laparoscopic cholecystectomy using warmed, humidified gas (new) against laparoscopic cholecystectomy with cool, dry gas (usual). Sample size of 200 patients. Outcome measures are postoperative opiate analgesia use, and post operative numerical pain scores.

Official Title
-----------------
Randomised Controlled Trail of Warmed Humidified Insufflation Versus Cold Non-Humidified Insufflation in Elective Laparoscopic Cholecystectomies: Does This Reduce Post-Operative Pain?

Conditions
-----------------
Gallstone

Intervention / Treatment
-----------------
* Other: Warm humidified C02
* Other: Cool dry C02


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: elective laparoscopic cholecystectomy 18 years of age or over Exclusion Criteria: under 18 years of age prisoners converted to open operation secondary invasive procedure during operation unable to give consent for whatever reason

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Patients receiving warmed, humidified gas | Other: Warm humidified C02<br>* Insufflation of warmed humidified gas during laparoscopic cholecystectomy<br>* Other names: Fisher Paykall laparoscopic humidifier;|
| Active Comparator: 2<br>Patients receiving cool, day gas | Other: Cool dry C02<br>* Insufflation of cool dry gas during laparoscopic cholecystectomy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total post operative opiate analgesia - morphine equivalent dose. |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective post operative pain as defined on numerical pain scales |  | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gallstones, Gallbladder, Cholecystectomy, Gallstone disease
Pilot Study of Text Message Reminders to Improve HIV Medication Adherence in Botswana

Study Overview
=================
Brief Summary
-----------------
While medication adherence is critical to successful treatment of HIV, there are few studies of interventions demonstrating improvements in adherence. This may be a particular challenge in the developing world, which has a larger burden of HIV but fewer resources than industrialized countries. The investigators propose a randomized controlled trial of cellular phone text message reminders to improve medication adherence. Our pilot study will be set in a large HIV clinic in Gaborone, Botswana, where Penn researchers have collaborated on research projects in the past. The primary study outcome will be antiretroviral medication adherence.

Official Title
-----------------
A Pilot Study of Cellular Phone Text Message Reminders to Improve HIV Medication Adherence at Independence Surgery Clinic Gaborone, Botswana

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Other: Cell phone text message


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV infected 21 years of age or older Exclusion Criteria: Subjects who do not intend to have continuous follow-up care and monthly medication refills at Independence Surgery for at least the next six months

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Cell phone text message|We will use cellular text messages to remind patients of impending drug prescription refills and scheduled visits to their healthcare provider.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIV medication adherence |  | Monthly | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, Antiretrovirals, Adherence, Text messaging, Antiretroviral adherence, Treatment experienced
Effect of Guided Imagery on Patients With Chronic Pain Related to Spinal Cord Injury

Study Overview
=================
Brief Summary
-----------------
Chronic pain after spinal cord injury in or below the level of injury is a common problem and can be severe. The purpose of our study is to investigate the effect of pleasant guided imagery on spinal cord injured patients with chronic pain in or below the level of injury.

Detailed Description
-----------------
The study is a controlled simple blind randomized prospective study. Subjects who live in Trøndelag ( Norway) and who have a traumatic or non traumatic spinal cord injury with chronic pain in or below the level of injury will be included in the study. Assessments: Pain will be measured with NRS(numeric pain rating scale) and BPIQ (Brief pain intervention questionnaire), anxiety and depression with BDI and BAI (Beck's depression and anxiety inventory) and quality of live with SF36 health survey. The subjects will be randomized in a treatment and control group. One group will use daily for four weeks a CD with a pleasant guided imagery, the other group will write a short pain diary. The NRS will be registered daily and the other assessments before and after the interventions.

Official Title
-----------------
Effect of Positive Guided Imagery on Patients With in or Below-level Chronic Pain Related to Spinal Cord Injury

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Behavioral: Pleasant guided imagery
* Behavioral: Pain diary


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Traumatic and non traumatic SCI (spinal cord injury) persons in Trøndelag (Norway) Exclusion Criteria: Not sufficient knowledge of the Norwegian language, cancer, serious cognitive impairment, abuse or dependence of alcohol, narcotics or analgesics and dissociative disorder
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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: guided imagery<br>CD | Behavioral: Pleasant guided imagery<br>* CD with pleasant guided imagery<br>|
| Active Comparator: pain diary<br>Pain diary | Behavioral: Pain diary<br>* Filling out a pain diary<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity | as measured by a numerical rating scale (daily) and Brief pain questionnaire (BPI) (baseline and after 4 weeks) | four weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BDI, BAI and SF36 |  | pre and postintervention |