linjc16/ctgov huggingface dataset:
Urinary Kallikrein and Hypertension: A Prospective Study

Study Overview
=================
Brief Summary
-----------------
To determine whether low total urinary kallikrein activity was prospectively associated with new hypertension onset or elevated blood pressures.

Detailed Description
-----------------
BACKGROUND: Statistical evidence had been found for a dominant major gene segregating in large pedigrees for high urinary kallikrein levels protecting against hypertension which explained 51 percent of the variance of total urinary kallikrein (TUK). In normotensive adult and pediatric pedigree members, low urinary kallikrein activity was associated with a positive family history of hypertension, stroke, and/or coronary disease. DESIGN NARRATIVE: The presence of a previously reported dominant major gene inferred from segregation analysis of total urinary kallikrein activity (TUK) in selected pedigrees was verified on already collected frozen urine specimens. Subjects were rescreened to obtain measured nine year follow-up blood pressure data. Individuals were classified by assigned baseline TUK genotype and tested to determine whether low TUK was prospectively associated with new hypertension onset or elevated blood pressures. Because a major gene effect was implicated, available probes for the structural kallikrein gene or other related products regulating kallikrein were tested for genetic linkage to TUK levels. Correlations with over 600 variables measured at baseline in pedigrees and twins were tested to analyze the strong familiality of environment, refine the genetic analyses to better assign genotypes, and detect gene-environment interactions. All baseline variables except kallikrein, aldosterone, and prostaglandin measurements on frozen urine and follow-up blood pressure had already been collected. TUK may be a marker for a renal, cellular or other physiological abnormality influencing both TUK expression and susceptibility to hypertension. Therefore, the relationship of TUK to urinary aldosterone, prostaglandin E excretion and already measured urinary electrolytes, plasma renin activity, and baseline and reactive blood pressures was determined. Genetic segregation analyses were performed of the urinary variables and other variables closely associated with TUK.

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

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 |
| --- | --- | --- |
Non-prescription Versus Prescription Topical Treatments Versus no Treatment in the Control of Sweating

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the effectiveness of the prescription treatment compared to the non-prescription treatment. It is hypothesized that the prescription treatment will have a significantly greater effect than the non-prescription treatment on decreasing excess sweating.

Detailed Description
-----------------
The objective of this study is to assess the effectiveness of the prescription treatment compared to the non-prescription treatment. It is hypothesized that the prescription treatment will have a significantly greater effect than the non-prescription treatment on decreasing excess sweating.

Official Title
-----------------
Non-prescription Versus Prescription Topical Treatments Versus no Treatment in the Control of Sweating

Conditions
-----------------
Hyperhidrosis, Excess Sweating

Intervention / Treatment
-----------------
* Drug: Drysol
* Drug: Drioff


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 21-30 years males and females The subjects are in good health. The subjects have willingness and the ability to understand and provide informed consent for participation in the study. Exclusion Criteria: Subjects with primary hyperhidrosis Subjects who are unable to withstand prolonged heat exposure or who have self-reported history of cardiovascular or respiratory disorders. Subjects who are unable to give informed consent. Subjects with mental illness. Subjects who are pregnant or nursing. Subjects with systemic or local skin disease and/or infection that may interfere with the conduct of the study.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 30 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>ARMs were randomized. One side of the body received treatment with one antiperspirant and the contralateral side with a different antiperspirant. | Drug: Drysol<br>* 20% aluminum chloride hexahydrate<br>|
| Experimental: 2<br>ARMs were randomized. One side of the body received treatment with one antiperspirant and the contralateral side with a different antiperspirant. | Drug: Drioff<br>* 1% aluminum acetate<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gravimetric analysis |  | 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject sweat assessment |  | 3 hours | 
| HDSS |  | 3 hours |
Trial of Homeopathy on Management of Menorrhagia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare outcomes and quality-of-life issues in the treatment of menorrhagia, this randomized double blind controlled trial compared homeopathy and placebo. Clinical criteria were confirmed the diagnosis, and subjective assessment of the condition was performed during one pre-treatment and three treatment cycles. outcome measures were bleeding days, intensity. average pads used during menstrual cycle, abdominal & back pain, General health and overall satisfaction.

Official Title
-----------------
Pilot Study of Homeopathy in Dysfunctional Uterine Bleeding Presenting as Menorrhagia

Conditions
-----------------
Menorrhagia

Intervention / Treatment
-----------------
* Drug: Homeopathy
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 35-49 years with regular heavy menstrual bleeding menstrual loss requiring more than 5 Pads/tampons per day menstrual cycle longer than 6 days Exclusion Criteria: Organic causes of menorrhagia History of renal or hepatic impairment, Endocrine disorder including diabetes, thyroidism Thromboembolic disease, Inflammatory bowel disease, Peptic or intestinal ulceration, or coagulation or fibrinolytic disorders and --Malignancy.

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 49 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br> | Drug: placebo<br>* corresponding placebo was identical in appearance of homeopathic globule prepared in alcohol.<br>|
| Experimental: Homeopathy<br>Individualized symptom based therapy | Drug: Homeopathy<br>* Each homeopathic medication was given as 1 g dose of homeopathic preparation in 30c potency. The dose is prepared as lactose globules on which the homeopathic preparation.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| daily assessment of bleeding | bleeding days, intensity of bleeding, average pads used, back and abdominal pain associated.daily assessment during menses were completed by participants at baseline before randomization and at each menses for 3 month of intervention period. | change from baseline over 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health related quality of life |  | change from baseline over 3 months |
Dynamic Arterial Elastance to Predict Postural Change Induced Hypotension

Study Overview
=================
Brief Summary
-----------------
During general anesthesia, hypotension might occur during positional change. It is reported that hypotension after positional change from supine to prone is mainly caused by the decrease in preload. The investigators aimed to investigate whether dynamic arterial elastance might predict hypotension associated with positional change from supine to prone.

Official Title
-----------------
Investigation on Dynamic Arterial Elastance as a Predictor of Hypotension Caused by the Positional Change From Supine to Prone (SuProne Study).

Conditions
-----------------
Hypotension

Intervention / Treatment
-----------------
* Other: Positional change from supine to prone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients planned for invasive arterial catheter insertion, undergoing elective spine surgery in prone position under general anesthesia Exclusion Criteria: arrythmia pulmonary disease increased intracranial pressure decreased cardiac function (ejection fraction < 50%) obesity (body mass index > 40)

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 |
| --- | --- |
| Non-hypotensive<br>Mean blood pressure is maintained after positional change from supine to prone. | Other: Positional change from supine to prone<br>* Patient is turned from supine to prone position for spine surgery<br>|
| Hypotensive<br>Mean blood pressure decrease < 20% after positional change from supine to prone. | Other: Positional change from supine to prone<br>* Patient is turned from supine to prone position for spine surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dynamic arterial elastance before positional change | Dynamic arterial elastance, defined as the ratio of pulse pressure variance/stroke volume variance will be recorded 1 minute before positional change | 1 minute before positional change |
Comparing the Prognosis of Lactate-directed and Goal-directed Therapy in Hyperthermic Intraperitoneal Chemotherapy.

Study Overview
=================
Brief Summary
-----------------
Hyperthermic intraperitoneal chemotherapy is a major surgery for tumor peritoneal metastasis. For anesthesiologist, the intra-operative fluid control is always a big challenge. We try to compare the prognosis of lactate-directed and goal-directed therapy. We expect to confirm the better prognosis of lactate-directed therapy.

Official Title
-----------------
Comparing the Prognosis of Lactate-directed and Goal-directed Therapy in Hyperthermic Intraperitoneal Chemotherapy.

Conditions
-----------------
Organ Failure, Multiple

Intervention / Treatment
-----------------
* Other: Lactate-directed therapy
* Other: Goal-directed therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients receiving hyperthermic intraperitoneal chemotherapy Exclusion Criteria: Unable to set arterial line Severe liver or renal disease Severe heart disease Unconscious patients

Ages Eligible for Study
-----------------
Minimum Age: 20 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lactate-directed therapy<br> | Other: Lactate-directed therapy<br>* If the lactate level elevates, we transfuse pRBC to increase Hct>30%. If Hct >30%, dopamine infusion starts.<br>Other: Goal-directed therapy<br>* If SVV>15%, transfuse lactate ringer/normal saline alternatively to keep SVV<15%.<br>|
| Experimental: Goal-directed therapy<br> | Other: Goal-directed therapy<br>* If SVV>15%, transfuse lactate ringer/normal saline alternatively to keep SVV<15%.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pulmonary complication | X-ray findings of airspace or interstitial opacity, lobar consolidation, or pleural effusions; severe respiratory failure requiring respiratory support | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal complication | oliguria with urine output<0.5 ml/kg/h for more than 4 h, creatinine increase>30 % of preoperative values, dialysis | 1 week |
Evaluation of NiTi Shape Memory End-to-End Compression Anastomosis Ring (CAR) for Compression Anastomosis in Anterior Resection

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and effectiveness of the NiTi CAR device in the creation of colorectal anastomosis

Official Title
-----------------
Evaluation of NiTi Shape Memory End-to-End Compression Anastomosis Ring (CAR) for Compression Anastomosis in Anterior Resection

Conditions
-----------------
Colorectal Cancer

Intervention / Treatment
-----------------
* Device: Compression Anastomosis Ring (CAR)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient age over 18 years Patient scheduled for colorectal cancer surgery Patient is able to comprehend and sign the Informed Consent Form Exclusion Criteria: Patient has known allergy to nickel Patient with bowel obstruction, bowel strangulation, peritonitis, bowel perforation, local or systemic infection Patients who are participating in another trial Patient on regular steroid medication Patients who are undergoing a stoma Patients with contraindications to general anesthesia Patient with preexisting sphincter problems or evidence of extensive local disease in the pelvis Patients after radiation Patients who refuse consent

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 |
| --- |
|Device: Compression Anastomosis Ring (CAR)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functioning anastomosis and no occurrence of adverse events related to device use |  | During hospitalization and one month post procedure |
Genetics of Peripheral Artery Genomics

Study Overview
=================
Brief Summary
-----------------
Peripheral artery disease is a disease that contributes to significant morbidity and mortality of millions of Americans yearly. Very little is known about the pathophysiology of atherosclerosis in peripheral artery disease. We plan to collect peripheral arteries and muscle tissue from patients undergoing amputation for end stage peripheral arterial occlusive disease. By extracting the RNA from these arteries and tissues and comparing them with RNA expression from normal arteries, we hope to have a better understanding of the pathophysiology of atherosclerosis in this setting. We aim to prove the hypothesis that a novel gene expression pattern can be discovered by the successful extraction of RNA from plaques from human peripheral arteries.

Detailed Description
-----------------
Patients scheduled to undergo lower extremity amputation will be consented for extraction of plaque from the carotid artery or arterial tissue from the amputated limbs. The surgeon will perform the amputation, then the harvest team will collect arterial tissue from amputated limbs. These samples will be immersed in RNALater solution to preserve the integrity of the RNA. Tissues will stored at -80oC in the RNALater until the RNA is later extracted using a standardized protocol. The RNA will be examined for quality using an Agilent bioanalyzer, and will then be processed on Affymetrix U133A chips for gene expression data. The data will be analyzed with the MATLAB software package.

Official Title
-----------------
Genetics of Peripheral Artery Disease

Conditions
-----------------
Peripheral Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing amputations for peripheral artery disease Patients undergoing free fibular transfer Exclusion Criteria: those that are not able to consent to the study
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 |
| --- | --- |
| arteries from PAD patients<br>peripheral arteries from patients undergoing amputation for end stage peripheral arterial occlusive disease | |
| arteries from Free Fib transfers<br>peripheral arteries from patients without evidence of peripheral arterial occlusive disease | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Discover novel gene expression pattern in peripheral arterial disease |  | ongoing | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Smoking, Hypertension, Diabetes, Cardiovascular disease, Renal Failure
Solid Tumor Cancer Surgery With or Without Intraoperative Imaging: A Registry

Study Overview
=================
Brief Summary
-----------------
The study objective is to collect prospective data on cancer patients who undergo surgery and intraoperative imaging. The registry will include (but not limited to) cancer type, stage, intraoperative challenges to the surgeon, usage and results of intraoperative imaging, and recurrence surveillance.

Detailed Description
-----------------
Our objective is to collect prospective data on cancer subjects who undergo surgery and intraoperative imaging. The registry will include (but not limited to) cancer type, stage, intraoperative challenges to the surgeon, usage and results of intraoperative imaging, and recurrence surveillance. In this protocol, subjects that receive intraoperative imaging will provide us the opportunity to record what tissues fluoresce in the operating room, and then to identify if these lesions are cancer when the histopathology is performed. Also, we will monitor any side effects or potential toxicities that may occur. This data can then be used to predict if a subject is more likely to develop a local recurrence due to missed cancer cells, metastatic lymph nodes or synchronous lesions.

Official Title
-----------------
Solid Tumor Cancer Surgery With or Without Intraoperative Imaging: A Registry Optional Sub-Study I: ICG Optional Sub-Study II: OTL38

Conditions
-----------------
Bladder Cancer, Gastric Cancer

Intervention / Treatment
-----------------
* Drug: OTL38
* Drug: ICG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients >/= 18 years of age. Patients presenting with esophagogastric or bladder cancer. Good operative candidate as determined by the treating physician and/or multidisciplinary team. Subject capable of giving informed consent and participating in the process of consent. Exclusion Criteria: Pregnant women as determined by urinary or serum beta hCG within 72 hours of surgery. Vulnerable patient population.

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: OTL38|Patients will be given imaging agent 2-3 hours before surgery to assist in imaging.|
|Drug: ICG|Patients will be given imaging agent 24 hours before surgery to assist in imaging.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tissue to Background Ratio | Enhance ability to detect malignant tissues in situ and ex vivo. | 2 years |
Study to Compare the Bioavailability of ABT-335 and Rosuvastatin From ABT-143 Relative to That From the Co-administration of ABT-335 and Rosuvastatin Calcium

Study Overview
=================
Brief Summary
-----------------
To evaluate safety and compare the pharmacokinetic parameters from the fixed dose combination ABT-143 relative to that from the co-administration of the two monotherapies.

Conditions
-----------------
Adverse Events, Pharmacokinetic

Intervention / Treatment
-----------------
* Drug: ABT-143
* Drug: ABT-335
* Drug: Rosuvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: General good health BMI 19 to 29 Exclusion Criteria: Currently enrolled in another study Females who are pregnant or breastfeeding

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>ABT-143 capsules 20/135 mg | Drug: ABT-143<br>* once daily for 6 days<br>|
| Active Comparator: 2<br>ABT-335 135mg and rosuvastatin 20mg | Drug: ABT-335<br>* once daily for six days<br>Drug: Rosuvastatin<br>* Once daily for 6 days<br>|
| Experimental: 3<br>ABT-143 capsules 5/45mg | Drug: ABT-143<br>* once daily for 6 days<br>|
| Active Comparator: 4<br>ABT-335 45mg and rosuvastatin 5mg | Drug: ABT-335<br>* once daily for six days<br>Drug: Rosuvastatin<br>* Once daily for 6 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse event and safety laboratory assessments |  | 7 days | 
| Pharmacokinetic parameters |  | 7 days |