linjc16/ctgov huggingface dataset:
Study to Assess the Effects of High Protein Diet in Obesity, the LOWER Study

Study Overview
=================
Brief Summary
-----------------
This program is carried out in a dedicated outpatient-clinic in the city of Hengelo for the evaluation and treatment of subjects with obesity. The program puts emphasis on intervention with appropriate diet and physical exercise, and supports the patients in achieving long-term behaviour changes. Interventions which are compared are normal vs high protein/low carb diets.

Detailed Description
-----------------
Assessment focuses on the effect of the specific diets on weight reduction after 3 months, and weight maintenance after 12 months.

Official Title
-----------------
The Lifestyle, OverWeight, Energy Restriction Study

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

Intervention / Treatment
-----------------
* Dietary Supplement: Normal protein energy-restricted
* Dietary Supplement: High protein energy-restricted


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Obesity with BMI > 27 kg/m2 Exclusion Criteria: Recent loss of body weight (>10%) Underlying malignancy, HIV infection, psychiatric disease Pregnancy or breast feeding

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Normal protein normal carbohydrate<br>Normal protein normal carbohydrate calory restricted nutrition | Dietary Supplement: Normal protein energy-restricted<br>* Normal protein diet energy restricted<br>|
| Experimental: Normal protein low carbohydrates<br>Normal protein low carbohydrate energy-restricted diet | Dietary Supplement: Normal protein energy-restricted<br>* Normal protein diet energy restricted<br>|
| Experimental: High protein normal carbohydrates<br>High protein normal carbohydrates | Dietary Supplement: High protein energy-restricted<br>* High protein diet, with either low or normal carbohydrate content<br>|
| Experimental: High protein low carbohydrate<br>High protein low carbohydrate nutrition | Dietary Supplement: High protein energy-restricted<br>* High protein diet, with either low or normal carbohydrate content<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
low carbohydrate, high protein diet
Evaluating Decisional Regret Among Mothers

Study Overview
=================
Brief Summary
-----------------
The anticipated birth of an extremely low gestational age infant presents many complex and ethically challenging questions, including whether to initiate resuscitation or comfort care after delivery. Failure to identify and align decision-making to parents' values during periviabilty counseling may result in greater opportunity for decisional regret. The goal of the proposed research is to assess decisional regret in mothers of extremely premature births and to compare decisional regret in mothers who chose resuscitation at time of delivery to those who chose comfort care. Approximately 1000 mothers of infants born extremely premature at 2 perinatal centers in the US will be surveyed.

Official Title
-----------------
Delivery Decisions in Extreme Prematurity: Evaluating Decisional Regret

Conditions
-----------------
Extreme Prematurity, Birth, Preterm, Pregnancy Preterm

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mothers of infants born between 22 and 25 completed weeks gestation during the study timeframe. Mothers who had a documented perinatal consult Greater than 18 years old Exclusion Criteria: Potential life limiting fetal diagnoses aside from prematurity and non-English primary language

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decisional regret | To assess decisional regret in mothers of extremely premature liveborn infants. | Within the last 14 years | 
| Comparison of decisional regret | Comparison of decisional regret in mothers who chose resuscitation versus mothers who chose comfort care at the time of delivery. | Within the last 14 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Define characteristics associated with decisional regret | Identify characteristics, and specifically potentially modifiable characteristics, that are associated with decisional regret in our population of mothers. | Within the last 14 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Decisional regret, Comfort care, Palliative care, Infant resuscitation
Reducing the Overall Risk Level in Patients Suffering From Metabolic Syndrome

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the efficacy of a multi factorial preventive scheme of action (including fluvastatin and valsartan) to reduce the overall risk level in patients with metabolic syndrome.

Official Title
-----------------
Project to Promote the Evaluation of the Cardiovascular Risk in the Clinical Practice and to Evaluate Its Evolution Following the Implementation of a Preventive Multifactorial Strategy Aimed to Reduce the Total Risk Level (SCORE Algorithm), in Subjects Suffering From Metabolic Syndrome and With a Risk Level ≥5%

Conditions
-----------------
Hypertension, Dyslypidaemia

Intervention / Treatment
-----------------
* Drug: Fluvastatin
* Drug: Valsartan
* Drug: Hydrochlorothiazide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 40 - 65 years Diagnosed metabolic syndrome Risk of cardiovascular death ≥ 5% (according to SCORE) Written informed consent Exclusion Criteria: Women not in menopause or not using efficient contraception Known hypersensitivity to study drugs History of ischemic heart disease

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Fluvastatin: daily 80 mg, oral | Drug: Fluvastatin<br>* Fluvastatin: daily 80 mg, oral<br>* Other names: Lescol;|
| Experimental: 2<br>Valsartan | Drug: Valsartan<br>* Valsartan: daily 160 mg, oral<br>* Other names: Diovan;|
| Experimental: 3<br>Hydrochlorothiazide | Drug: Hydrochlorothiazide<br>* Hydrochlorothiazide: daily 12.5mg, oral<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in global risk from baseline to 3 and 9 months, as evaluated by the SCORE algorithm |  | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline after 3 and 9 months in the individual risk factors (e.g. blood pressure, lipid variables) |  | 9 month | 
| Proportion of patients with controlled glycemia |  | 9 months | 
| Percentage of patients no longer classifiable as having metabolic syndrome |  | 9 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension, dyslipidemia
A Study to Characterize the Pharmacokinetics of DA-8031 in Healthy Male Subjects

Study Overview
=================
Brief Summary
-----------------
This is a dose block-randomized, double-blind, placebo-controlled, single/multiple dosing, dose-escalation study. The study is designed to describe the relationship between multiple doses and pharmacokinetic parameters of DA-8031 as well as safety profile.

Official Title
-----------------
A Dose Block-randomized, Double-blind, Placebo-controlled, Single/Multiple Dosing, Dose-escalation Clinical Trial to Investigate the Safety, Tolerability, and Pharmacokinetic Characteristics of DA-8031 After Oral Administration in Healthy Male Subjects

Conditions
-----------------
Premature Ejaculatory Dysfunction

Intervention / Treatment
-----------------
* Drug: DA-8031
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 20-45 years healthy male subjects Body weight :60-90kg, BMI between 18.5-25 Exclusion Criteria: show SBP(Systolic Blood Pressure) =<100mmHg or >=140mmHg, or DBP(Diastolic Blood Pressure)=<60mmHg or >=90mmHg, or tachycardia (PR(Pulse Rate)>=100times/min) have a history of drug abuse or show positive for drug abuse or cotinine at urine screening smokers

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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 |
| --- | --- |
| Experimental: DA-8031<br> | Drug: DA-8031<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To characterize the pharmacokinetic parameters such as AUC(Area under concentration-time curve), Cmax, Tmax, T1/2, fe, and CL/F of DA-8031 by as assessment of plasma and urine concentration |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety and tolerance of DA-8031 by assessment of vital signs, clinical laboratory tests, physical examinations, ECG findings, and adverse events collected by investigator questionnaire and subjects spontaneous report |  |  |
The Biofeedback Therapy in Solitery Rectal Ulser Patients BIOFEEDBACK THERAPY

Study Overview
=================
Brief Summary
-----------------
Dissynergic defecation causes solitery rectal ulcer. The biofeedback therapy improves dissynegy and heals soliter rectal ulcer.

Detailed Description
-----------------
dyssynergia treating ulcers caused by treatment with biofeedback

Official Title
-----------------
The Biofeedback Therapy in Solitery Rectal Ulser Patients

Conditions
-----------------
Rectal Ulcer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: solitary rectal ulcer in rectosigmoidoscopy type 1 or 3 dissynergic defecation to accept to participate to study and sign informed consent Exclusion Criteria: previously applied biofeedback serious psychiatric disorder previous anorectal surgery the presence of active malignancy

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ulcer diameter shrinkage | ulcer diameter measured in rectosigmoidoscopy | 6-8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
biofeedback, solitery rectal ulcer, dissynergy
Epidemiology of Interstitial Lung Disease

Study Overview
=================
Brief Summary
-----------------
To establish a population-based registry of interstitial lung disease in Bernalillo County, New Mexico.

Detailed Description
-----------------
BACKGROUND: Although many investigations have been conducted to characterize the pathogenesis of interstitial lung diseases, few examined the epidemiology of these disorders in a general population. The establishment of the registry represented the first step in a sequence of investigations designed to characterize the epidemiology of the interstitial lung diseases. The registry initially served a descriptive purpose; the incidence of the interstitial lung diseases was measured in a defined population. Subsequently the registry served as a mechanism for ascertaining cases for a case-control study. Finally, the registry provided population-based data for clinical purposes on presentation, physiology, and natural history of the interstitial lung diseases. DESIGN NARRATIVE: The resources of the New Mexico Tumor Registry were adapted to identify new cases of interstitial lung disease in Bernalillo County. Other sources of information for identifying new cases included pulmonary physicians, primary care physicians, death certificates, and autopsies. After a case of interstitial lung disease had been identified from the various sources of information, data collection included an interviewer-administered symptoms questionnaire, abstracted medical record data, phlebotomy for measurement of serum precipitins, and evaluation of available chest x-rays and biopsy materials. Follow-up was used to determine the natural history of the disease. The study was renewed in 1993 to complete the work conducted from 1988 through 1992. Case-ascertainment, data collection, and follow-up of incident cases of ILD identified during the period 10/1/88-9/30/92 were completed. The incidence of ILDs was described. The clinical characteristics of patients with ILDs were described. The prognosis of the most common ILDs were described.

Conditions
-----------------
Lung Diseases, Lung Diseases, Interstitial

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 |
| --- | --- | --- |
Safety and Efficacy of KALOMIN™ Tab. in Patients With Acute Bronchitis

Study Overview
=================
Brief Summary
-----------------
This is a multi-center, double-dummy, double-blind, randomized, active-controlled, parallel group phase 3 clinical trial to evaluate the efficacy and safety of KALOMIN™ Tab. in patients with acute bronchitis. The aim of this clinical trial is to demonstrate that KALOMIN™ Tab. is clinically non-inferior to Umckamin syrup, as assessed by BSS(Bronchitis Severity Score), in the treatment of acute bronchitis after 7 days.

Conditions
-----------------
Acute Bronchitis

Intervention / Treatment
-----------------
* Drug: KALOMIN™ Tab.
* Drug: Umckamin syrup


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patients aged 12-75 years old A total score of BSS ≥ 5 The duration of symptoms had to be less than 14 days and no chronic pulmonary disease Patients who voluntarily sign a written informed consent to participate in the trial Exclusion Criteria: Indication for antibiotic treatment(e.g. severe respiratory infection) Allergic bronchial asthma Tendency to bleed Severe heart, renal, or liver diseases or decline of immune function Chronic obstructive pulmonary disease Known or supposed hypersensitivity to investigational medication Treatment with antibiotics during the past 4 weeks prior to inclusion in the trial Women during pregnancy or lactation period Clinically significant abnormal values in the screening test(more than twice the upper limit of normal range for ALT, AST, BUN, and Serum Creatinine) Participation in any other trial within 30 days prior to inclusion in the trial Unsuitable patients for enrollment in the opinion of the investigator

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 75 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: KALOMIN™ Tab.<br>KALOMIN™ Tab./Placebo to Umckamin syrup | Drug: KALOMIN™ Tab.<br> <br> |
| Active Comparator: Umckamin syrup<br>Umckamin syrup/Placebo to KALOMIN™ Tab. | Drug: Umckamin syrup<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total score of BSS(Bronchitis Severity Score) |  | 7days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Individual symptom score of BSS |  | 7days | 
| reaction rate of treatment |  | 7days | 
| IMOS(Integrative Medicine Outcome Scale) |  | 7days | 
| IMPSS(Integrative Medicine Patient Satisfaction Scale) |  | 7days | 
| Adverse events, clinical laboratory examination, physical examination, etc. |  | 7 days |
A1c FIT TEST: An Epidemiological Study Correlating Hemoglobin A1c With Results of the Air Force Physical FITness TEST.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the prevalence of pre-diabetes and diabetes among those Air Force personnel who have not passed the Air Force physical fitness test (AFPT) and to evaluate the usefulness of the AFPT as a prescreening tool for these disease processes.

Official Title
-----------------
A1c FIT TEST: An Epidemiological Study Correlating Hemoglobin A1c With Results of the Air Force Physical FITness TEST.

Conditions
-----------------
Pre-Diabetes, Diabetes, Cardiovascular Risks

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: Tricare Insurance Beneficiary (military insurance) receiving care at Nellis AFB Over the age of 18 and took their AFPT within the past 1 month. Exclusion: Previous diagnosis of diabetes Pregnant or nursing

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| failed and passed physical fitness test<br>520 subjects who have failed their Air Force physical fitness test and 520 volunteers who have passed their physical fitness test both within the last 6 months | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Do Air Force personnel who fail the Air Force physical fitness test have a higher incidence of pre-diabetes than those who pass the test? | Do Air Force personnel who fail the Air Force physical fitness test have a higher incidence of pre-diabetes than those who pass the test? | within 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| And for those who fail, do they have higher cardiovascular risks as correlated with fasting lipid panel. | And for those who fail, do they have higher cardiovascular risks as correlated with fasting lipid panel. | within 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pre-Diabetes, Diabetes, cardiovascular risks
Identifying Molecular Drivers of Cancer

Study Overview
=================
Brief Summary
-----------------
The primary aim of this study is to identify drivers of cancer by performing comprehensive genetic, proteomic, and metabolomic characterization of patient samples as a basis for understanding the underlying cause of disease.

Detailed Description
-----------------
This study involves looking at the DNA, RNA, proteins, and metabolites in blood and tissue samples collected from subjects and linking them to their health information. By doing so, researchers hope to discover the underlying molecular causes of human diseases with the hope that this information can be used for the development of diagnostic tests and more effective treatments.

Official Title
-----------------
Identifying Molecular Drivers of Cancer

Conditions
-----------------
Cancer, Tumor, Advanced Cancer

Intervention / Treatment
-----------------
* Genetic: Molecular profile


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnoses with cancer but healthy enough to undergo a biopsy procedure Between the ages of 18 and 100 Exclusion Criteria: Patients who are pregnant

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 |
| --- | --- |
| Molecular profile<br>Molecular profiled group receiving treatment based on genetics | Genetic: Molecular profile<br>* Patients and their treating physician will obtain the patient's genetic risk assessment<br>* Other names: Genomic targeting;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genetic profiling | To determine genetic changes associated with the development and growth of human disease. This should lead to better ways to detect, prevent, and treat a wide variety of human health conditions, including cancer. | Up to 15 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
genetic sequencing, genome, cancer, DNA, RNA, protein, metabolite