linjc16/ctgov huggingface dataset:
Reference Curve on Bone Mineral Density in Men

Study Overview
=================
Brief Summary
-----------------
In men, the hope of lower life, the absence of equivalent of menopause and the existence of a higher peak bone mass are the three factors that explain the lower incidence of osteoporosis in men.

Official Title
-----------------
Reference Curve on Bone Mineral Density in Men

Conditions
-----------------
Bone Mineral Density, Grip Strength, Physical Performance

Intervention / Treatment
-----------------
* Diagnostic Test: Bone densitometry measurement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male Aged between 20 and 30 years Caucasians Exclusion Criteria: Lack of express consent Pieces of metal or plastic parts in field Diseases which cause technical difficulties for the correct evaluation of the hip and spine (severe dysplasia, hip surgery or lumbar spine) Adult protect buy the law

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 30 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bone Mineral Density<br>Bone densitometry measurement: measurement of bone mineral densitometry with bone densitometry | Diagnostic Test: Bone densitometry measurement<br>* Bone densitometry and measurement of body composition<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone mineral density of the spine | to establish reference curves in elderly mal volunteers from 20 to 30 years through the assessment of bone mineral density of the spine | Day 0 | 
| Bone mineral density of the hip | to establish reference curves in elderly mal volunteers from 20 to 30 years through the assessment of bone mineral density of the hip | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fat mass of the body | to establish reference curves in elderly mal volunteers from 20 to 30 years through the assessment of body composition | day 0 | 
| Lean mass of the body | to establish reference curves in elderly mal volunteers from 20 to 30 years through the assessment of body composition | day 0 |
Treatment With Local PPARgamma Ligand in Distal Ulcerative Colitis

Study Overview
=================
Brief Summary
-----------------
Treatment with PPARgamma ligands have been shown to reduces intestinal inflammation in murine models of colitis. The aim of this study was to evaluate the effect of treatment with local PPARgamma ligand (rosiglitazone) in distal ulcerative colitis.The patients are treated with rosiglitazone enema, once a day, for fourteen days. Disease activity was assessed before and after treatment by endoscopical and clinical activity score.

Conditions
-----------------
Ulcerative Colitis

Intervention / Treatment
-----------------
* Drug: Rosiglitazone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Distal ulcerative colitis (Mayo Clinical Score > 7) Age > 18 years Written consent Exclusion Criteria: Age < 18 years Severe ulcerative colitis Systemic treatment with steroids or azathioprin within the last 3 month Known liver or kidney disease Severe heart failure Pregnancy or breast feeding

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical response |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endoscopic response |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PPARgamma ligand, Rosiglitazone, Enema
AZD8566 Food Effect/Microtracer Study

Study Overview
=================
Brief Summary
-----------------
A study designed to look at how the drug AZD8566 is taken up by the body when given with or without food. In some subjects a comparison will be made with a very small labelled microdose given into a vein.

Official Title
-----------------
An Open, Randomised, Phase I, 2-Period Crossover Trial to Investigate the Absolute Bioavailability and the Effect of Food on the Oral Bioavailability of AZD8566 in Healthy Volunteers

Conditions
-----------------
Healthy Volunteer Study

Intervention / Treatment
-----------------
* Drug: AZD8566
* Drug: AZD8566 IV carbon labelled


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of written informed consent Clinically normal physical findings and laboratory values as judged by the investigator with normal ECG Females who are permanently or surgically sterile or post-menopausal and males Exclusion Criteria: History of any convulsions or seizures History of infection or risk of infection due to recent surgery or trauma History or presence of conditions know to interfere with the absorption, distribution, metabolism and excretion of the study drug

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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: AZD8566|Single 6 mg oral solution dose|
|Drug: AZD8566 IV carbon labelled|Single 10 mcg intravenous carbon-14 microtracer dose|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic profile: concentration of AZD8566 in blood in the presence or absence of food |  | Samples taken during visit 2 and visit 3, at up to 16 defined timepoints pre and post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of AZD8566 in healthy volunteers in the fed and fasted state by assessment of vital signs, laboratory variables, ECGs and adverse events |  | Assessments taken during visit 1 and at defined timepoints pre and post dose during visits 2 and 3. Volunteers will be monitored throughout the study for adverse events. | 
| Bioavailability of an oral solution formulation of AZD8566 in the fasted state compared with an intravenous carbon-14 microtracer dose |  | Samples taken during visit 2, at up to 40 defined timepoints pre and post dose | 
| Intravenous pharmacokinetics |  | Samples taken during visit 2, at up to 40 defined timepoints pre and post dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy Volunteer, AZD8566, Food Effect, Microtracer
Impact of Peer Education Program on Headache Disorders

Study Overview
=================
Brief Summary
-----------------
Worldwide, headache disorders are among the most common medical conditions. Many people with headache need not experience further pain if the diagnosis and treatment are correct. Most patients do not have correct diagnosis and treatment. This study tested a model for treatment of people with headache disorders at primary health-care level in rural areas of Haryana, India.

Official Title
-----------------
Impact of Peer Education Program on Headache Disorders in Rural Communities, India: a Quasi-experimental Study

Conditions
-----------------
Headache Disorder

Intervention / Treatment
-----------------
* Other: Community education programs


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All residents of the Region Kaithal (haryana) may apply for recruitment Primary headache disorders including tension type headache, migraine Exclusion Criteria: Planning to move the area Refused to consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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: Intervention<br>community support program | Other: Community education programs<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in number of days per month with headache after 12 months |  | From baseline to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in number of days per month of over the counter drugs after 12 months |  | From Baseline to 12 Months |
B14 Meningococcal Carriage in Seine-Maritime Population: Prevalence Study and Search of Risk Factors

Study Overview
=================
Brief Summary
-----------------
Our main objectives are to evaluate the importance of meningococcal carriage and to determine the predisposing factors

Official Title
-----------------
B14 Meningococcal Carriage in Seine-Maritime Population: Prevalence Study and Search of Risk Factors

Conditions
-----------------
Meningococcal Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Living in the area of Dieppe Parental authority assent if necessary Exclusion Criteria: Child under supervision
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
carriage, Neisseria meningitidis, risk factors
Biomarkers of Bone Resorption in Metastatic Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
Biomarkers of bone resorption will be measured in the blood of patients with bone metastases from prostate cancer during the course of their illness. Changes in these biomarkers will be correlated with the patient's treatment with antiandrogen therapy and bisphosphonates and the response and/or progression of their cancer. It is hoped that serial measurement of these biomarkers may allow therapeutic monitoring in the future with successful individualisation of bisphosphonate therapy for metastatic prostate cancer.

Official Title
-----------------
Measurement of Biomarkers of Bone Resorption in Patients With Hormone Sensitive Bone Metastases From Prostate Cancer Treated With Antiandrogen Therapy and Bisphosphonates

Conditions
-----------------
Metastatic Prostate Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: prostate cancer with bone metastases hormone sensitive Exclusion Criteria: inadequate renal function ongoing dental problems previous bisphosphonate therapy

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Bone Metastases<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Peripheral Effects of Endotoxin on Insulin Resistance

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to isolate the direct effects of endotoxin on glucose, lipid and protein metabolism. Eight healthy volunteers are enrolled. The hypothesis is that endotoxin will induce insulin resistance, lypolysis and proteolysis acutely.

Official Title
-----------------
The Effect of Regional Inflammation on Metabolism and Insulin Sensitivity in the Lower Extremity.

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Biological: USP endotoxin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal health 22 < BMI < 28 Written Informed Concent Exclusion Criteria: Any disease Any use of medication Recent immobilization of a lower extremity

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endotoxin<br> | Biological: USP endotoxin<br>* Continuous intra-arterial infusion<br>* Other names: USP Endotoxin, LOT: G3E069;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glucose concentration |  | 360 minutes observation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Regional arteriovenous amino-acid balance |  | measured at t=180 and 360 minutes | 
| Intra-cellular insulin signaling |  | measured at t=0, 120, and, 210 minutes | 
| Regional arteriovenous lipid balance |  | measured at t=180 and 360 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endotoxin, Insulin resistance, Lipolysis, Proteolysis, Intracellular Insulin Signaling, Regional effects of inflammation/endotoxin
Functional Predictive Value of Collective Outcome Measure(s) Status Post Total Hip/Knee Arthroplasty

Study Overview
=================
Brief Summary
-----------------
Researchers are trying to assess a predictive value or correlation of outcome measures results on subjects following a total knee or total hip arthroplasty in order to better predict the time frame taken to achieve certain functional milestones that are pertinent to subject population.

Detailed Description
-----------------
Subjects will undergo testing for a normal physical therapy clinical assessment that is standard of care for anyone who has a total hip or total knee surgery. Researchers will be using the data obtained from standard therapy care and see if correlations exist from that data and the time taken to complete specific functional tasks.

Official Title
-----------------
Functional Predictive Value of Collective Outcome Measure(s) Status Post Total Hip/Knee Arthroplasty

Conditions
-----------------
Joint Arthroplasty, Knee and Hip

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient's 18 years or older Patients who recently underwent a primary total hip or total knee arthroplasty Patient who recently underwent a total hip or total knee revision Exclusion Criteria: Patients who lack the ability to provide informed consent Patients with previous total joint replacement within the last 6 months Patients with complications following surgery such as DVT/PE/Infection

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Assistive Device Weaning | Number of days to weaning from all assistive devices | Approximately 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weaning from pain medication, ability to reciprocally use steps, ability to walk 1 mile or 30 minutes consecutively | Number of days taken to achieve milestones | Approximately 3-6 months |
Sitz Bath vs no Sitz Bath in Acute Anal Fissure Treatment

Study Overview
=================
Brief Summary
-----------------
To compare the efficacy of 'sitz bath' and 'no sitz bath' treatment in terms of pain improvement, rate of cure and fissure healing in Acute Anal Fissure.

Detailed Description
-----------------
ABSTRACT Objective To compare the efficacy of 'sitz bath' and 'no sitz bath' treatment in terms of pain improvement, rate of cure and fissure healing in Acute Anal Fissure. Study Design Randomized Controlled Trial Place and Duration of Study Department of Surgery Combined Military Hospital, Quetta, from15 January 2019 to 15 August 2021. Patients and Methods Individual patients were randomized to either receive 'sitz baths' or 'no sitz baths' treatment for 4 weeks. Patients were asked to have 'sitz bath' once in morning and again at bedtime, after each week pain scores and healing of fissure were assessed. Main outcome measures were validated. Keywords Acute anal fissure, pain, sitz bath

Official Title
-----------------
Comparison of Sitz Bath and no Sitz Bath Treatments in Patients With Acute Anal Fissure

Conditions
-----------------
Pain, Postoperative

Intervention / Treatment
-----------------
* Other: Sitz Bath


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients of acute anal fissure of both genders between 18 to 60 years Exclusion Criteria: While the patients with history of recurrent fissure, chronic anal fissure, pregnant woman and patients who were operated previously for any anorectal pathology were excluded from the study.

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sixty patients completed trial in two groups<br> | Other: Sitz Bath<br>* Individual patients were randomized to either receive 'sitz baths' or 'no sitz baths' treatment for 4 weeks. Patients were asked to have 'sitz bath' once in morning and again at bedtime, after each week pain scores and healing of fissure were assessed. Main outcome measures were validated<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| healing of fissure | healing of fissure after 4 weeks sitz bath | four weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute anal fissure, pain, sitz bath
Bariatric Surgery and Pharmacokinetics of Valsartan

Study Overview
=================
Brief Summary
-----------------
Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study the pharmacokinetic effects of bariatric surgery on valsartan are investigated.

Official Title
-----------------
Bariatric Surgery and Pharmacokinetics of Valsartan: BAR-MEDS Valsartan

Conditions
-----------------
Obesity, Morbid

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Preparing to undergo gastric bypass or sleeve gastrectomy in Central Norway Being a Norwegian citizen Exclusion Criteria: Having previously undergone resections in the GI-tract

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Valsartan|Patients are tested for their normal prescription valsartan medication|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Valsartan concentration in blood serum (area under curve (AUC)) |  | From baseline to 1 year postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Biological availability, Bariatric surgery, Gastrointestinal tract, Pharmacokinetics, Valsartan