linjc16/ctgov huggingface dataset:
Clinical Evaluation of Genetron TERT PCR Kit in Glioma Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this trail is to evaluate the performance of Genetron TERT PCR Kit in Glioma patients using real-time PCR method.

Detailed Description
-----------------
This trial follows the principle of synchronous blinding. The enrolled cases are coded, and the enrolled samples are detected with the Genetron TERT PCR Kit and Sanger sequencing method. The results were determined independently according to the cutoff values or interpretation requirements provided by each method.Combined with the results of clinicopathological classification, the incidence of C228T and C250T mutations of TERT promoter genes in different subtypes was counted to evaluate the clinical application performance of the Genetron TERT PCR Kit.

Official Title
-----------------
Clinical Evaluation of Genetron TERT PCR Kit in Glioma Patients

Conditions
-----------------
Glioma, Malignant

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Enroll cases in strict accordance with the requirements of the study The remaining samples after routine clinical testing The collection and processing of samples meet the requirements of standard laboratory operations and product instructions The relevant information of the sample is complete, including sample number, gender, age, and possible clinical diagnosis information Each sample must have HE staining results (hematoxylin-eosin staining) Pathological examination diagnosed as glioma, other brain tumors or normal tissues Number of samples: 10 pieces of each sample with a thickness of 10μm, and the tumor content is not less than 50% Exclusion Criteria: The sample information is not complete Severely contaminated samples Samples that do not meet the requirements of sample collection and processing
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 |
| --- | --- | --- |
| Efficacy of the Genetron TERT PCR Kit | The main purpose of this study is: by evaluating the Genetron TERT PCR Kit to compare the results of the Sanger sequencing method, and to calculate the coincidence rate and consistency of the two methods. | 3 months |
Exercise for Patients With HIV Infections

Study Overview
=================
Brief Summary
-----------------
The investigators will evaluate the effects of an endurance exercise program on the physical performance, the well being, and indicators of metabolic function in patients with an HIV infection.

Official Title
-----------------
Effects of an Exercise Program on Metabolic Parameters of Patients With a HIV Infection.

Conditions
-----------------
HIV Infections, Lipodystrophy, Inflammation

Intervention / Treatment
-----------------
* Behavioral: Exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 to 65 HIV infection Antiviral therapy Understanding of written German Exclusion Criteria: Diabetes mellitus All conditions which can be aggravated by exercise

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br> | Behavioral: Exercise<br>* 12 weeks endurance training, 3 times weekly for 35 minutes<br>|
| No Intervention: Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal oxygen uptake (VO2max) |  | At recruitment and after 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life |  | At recruitment and after 12 weeks | 
| Indicators of fat metabolism |  | At recruitment and after 12 weeks | 
| Markers of inflammation |  | At recruitment and after 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, Exercise, Inflammation, Quality of life, Lipodystrophia
Investigation Of Safety And Pharmacokinetics Following A Single Oral Dose Of 300 Mg Maraviroc In Healthy Male Japanese Volunteers

Study Overview
=================
Brief Summary
-----------------
To confirm safety and pharmacokinetics of maraviroc following a single oral dose of 300 mg maraviroc in healthy male Japanese volunteers.

Official Title
-----------------
An Open Label Single Dose Study To Investigate Safety And Pharmacokinetics Of Maraviroc Following A Single Oral Dose Of 300 Mg Maraviroc (Two 150 Mg Maraviroc Commercial Tablets) Under Fasting Conditions In Healthy Male Japanese Volunteers

Conditions
-----------------
Human Immunodeficiency Virus (HIV) Infection

Intervention / Treatment
-----------------
* Drug: maraviroc (Selzentry, Celsentri)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male Japanese subjects between the ages of 21 and 50 years inclusive. Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >45 kg. Exclusion Criteria: Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). Positive result for HIV, Hepatitis B surface antigen (HbsAg) or HCV antibody. Hypersensitivity/allergic reactions to any component of maraviroc, including soy lecithin.

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Active group<br>maraviroc dosing group | Drug: maraviroc (Selzentry, Celsentri)<br>* 12 subjects will receive a single dose of 300 mg maraviroc (two 150 mg maraviroc commercial tablets) under fasting conditions.<br>* Other names: Selzentry, Celsentri;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma and urine maraviroc concentrations for pharmacokinetic analysis |  | pre-48 hrs post dose | 
| Adverse event monitoring |  | Day 0 to Day 3 | 
| Bood pressure, pulse rate |  | Day 0, Day 1, and Day 3 | 
| Blood and urine safety laboratory tests |  | Day 0 and Day 3 | 
| ECG |  | Day 0 and Day 3 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pharmacokinetics, Japanese, healthy volunteer, maraviroc
Valsartan/Hydrochlorothiazide Combination in Hypertensive Patients Not Controlled With Valsartan Alone

Study Overview
=================
Brief Summary
-----------------
This study will test the effectiveness and safety of a combination treatment in patients whose blood pressure is not controlled with a single medication.

Official Title
-----------------
Comparison of the Combination of Valsartan 320 mg Plus Hydrochlorothiazide 12.5 mg and Valsartan 320 mg Plus Hydrochlorothiazide 25 mg to Valsartan 320 mg in Mild to Moderate Hypertensive Patients Not Adequately Controlled With Valsartan 320 mg

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: valsartan plus hydrochlorothiazide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with mild to moderate hypertension Exclusion Criteria: Severe hypertension History of stroke, myocardial infarction, heart failure, chest pain, abnormal heart rhythm Liver, kidney, or pancreas disease Insulin dependent diabetes Allergy to certain medications used to treat high blood pressure Other protocol-defined exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: valsartan plus hydrochlorothiazide|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in diastolic blood pressure from baseline after 8 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in systolic blood pressure from baseline after 8 weeks |  |  | 
| Change from baseline in standing systolic and diastolic blood pressure after 8 weeks |  |  | 
| Diastolic blood pressure less than 90 mmHg or at least a 10 mmHg decrease in diastolic pressure after 8 weeks |  |  | 
| Diastolic blood pressure less than 90 mmHg after 8 weeks |  |  | 
| Adverse events and serious adverse events at 8 weeks |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypertension, high blood pressure, valsartan, hydrochlorothiazide
Evaluation of Spot Urine as a Biomarker of Fluid Intake in Real Life Conditions

Study Overview
=================
Brief Summary
-----------------
Evaluate urine osmolality as a marker of fluid intake, in healthy subjects displaying a wide range of fluid intake behaviors

Conditions
-----------------
Healthy Adults

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy female and male subjects aged 20- 30 years old (both ages included). BMI within the range 20-25 kg/m2 (both inclusive). Height within the range 1.60-1.75 m (both inclusive) for female subjects and 1.70-1.85 m (both inclusive) for male subjects. Monophasic contraceptive method (female subjects only) Smoking less than 10 cigarettes/day Fluid intake habits falling within one of three designated arms Exclusion Criteria: Pregnant woman (as determined by a pregnancy test) or woman planning to become pregnant during the study; breast-feeding woman. Any clinically relevant acute or chronic diseases which could interfere with the subjects' safety during the trial, or expose them to undue risk, or which could interfere with the study objectives. Having participated in a clinical study for the renal diseases or having received any treatment related to the kidneys, cardiovascular disease or to hypertension in the last 12 months.

Ages Eligible for Study
-----------------
Minimum Age: 20 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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A = Increase water intake 1<br>+ 1,5 to 2,0 L/day of water | Other: Water<br> <br> |
| Experimental: B = Increase water intake 2<br>+ 1,0 to 1,5 L/day of water | Other: Water<br> <br> |
| Other: C = no change<br>No change | Other: No intervention<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Osmolality |  | baseline |
Vocal in Assessment of Endometrium in Postmenopause

Study Overview
=================
Brief Summary
-----------------
The unbalanced estrogen with no progesterone will lead to endometrial thickening .This thickening result in endometrial hyperplasia & carcinoma and lead to irregular bleeding

Detailed Description
-----------------
Recent advances in the screening and diagnosis of endometrial pathologies (eg,endometrial hyperplasia , endometrial carcinoma ,endometrial polyps and myomas ) are directed towards non invasive methods as Transvaginal ultrasound with 3 D application using different softwares . One of the applications of 3D Transvaginal Ultrasonography is Vocal technique ( Virtual Organ Computer aided Analysis ) that can measure volume especially in tissues with irregular borders And this technology is considered to be superior than the conventional 2 D ultrasound . .

Official Title
-----------------
The Relation Between Endometrial Volume by 3D Vocal Ultrasound and Histopathology in Women With Postmenopausal Bleeding

Conditions
-----------------
Postmenopausal Bleeding

Intervention / Treatment
-----------------
* Diagnostic Test: 3D ultrasound
* Procedure: Dilatation and curretage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Postmenopausal women who were Complaining of Post-menopausal vaginal bleeding. Exclusion Criteria: Women with hormone replacement therapy. Women showing intra-cavitary fluid collection at ultrasound examination Women with other gynecological lesions in the pelvis other than the uterus Previous diagnosis of endometrial pathology.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: 3D ultrasound|it describes the diagnostic test which is 3D us to diagnose the cause of postmenopausal bleeding|
|Procedure: Dilatation and curretage|it describes the surgical maneuver that will be made to diagnose cause of bleeding|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the number of participants who where diagnosed by 3D vocal to have endometrial carcinoma | it describes how many women will be properly diagnosed with carcinoma | within 4 weeks |
Optical Frequency Domain Imaging for Assessing Colonic Polyps

Study Overview
=================
Brief Summary
-----------------
The goal of this research is to conduct a pilot clinical study to image colonic polyps with the intent to evaluate the potential use of Optical Frequency Domain Imaging (OFDI) to identify the extent of invasion (if present), differentiate between hyperplastic polyps and adenomas, and identify serrated polyps.

Detailed Description
-----------------
The colon OFDI catheter will be used in conjunction with a sigmoidoscope. If a sigmoid polyp is identified, the colonoscope will be removed and a sigmoidoscope inserted. The colon OFDI catheter will be advanced through the sigmoidoscope accessory port and positioned adjacent to the colon wall. Imaging will be performed with the OFDI system across the polyp's surface and the base/stalk if pedunculated. The investigators anticipate that on average the investigators will utilize 4 helical scans per polyp. Each of the scans will take less than 30 seconds.

Official Title
-----------------
Pilot Study to Evaluate Optical Frequency Domain Imaging as a Tool for Assessing Colonic Polyps

Conditions
-----------------
Colonic Polyps

Intervention / Treatment
-----------------
* Device: MGH Optical Frequency Domain Imaging (OFDI) System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing a screening colonoscopy Patients must be over the age of 18 Patient must be able to give informed consent Exclusion Criteria: Patients with hemostasis disorders Patients taking any anti-coagulants such as Coumadin or Plavix,

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OFDI imaging<br>OFDI imaging | Device: MGH Optical Frequency Domain Imaging (OFDI) System<br>* Imaging of Colonic Polyps with OFDI system<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility and Sensitivity of OFDI Imaging in the Colon | OFDI Images are analyzed and compared to standard of care biopsies in order to differentiate hyperplastic polyps from adenomas or to identify serrated polyps. A total of 15 subjects were consented, but upon inspection of the colon only 2 participants met the eligibility criteria and participated. | During the OFDI imaging session which should take an average of 5 mintues | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Colonic Polyps, OCT, Imaging, Colon, Polyp
Bryophyllum vs. Nifedipine

Study Overview
=================
Brief Summary
-----------------
In a prospective, randomised study the efficacy and tolerability of bryophyllum p. (p.o) vs. nifedipine (p.o) will be proofed in a defined group of pregnant women with threatened preterm labour.

Official Title
-----------------
Bryophyllum p. Versus Nifedipine for the Treatment of Premature Contractions

Conditions
-----------------
Tocolysis

Intervention / Treatment
-----------------
* Drug: Bryophyllum p.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female Exclusion Criteria: Bishop Score > 5

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

| Intervention/Treatment |
| --- |
|Drug: Bryophyllum p.|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
-----------------
Nifedipine, Bryophyllum p., Tocolysis
Hepatic Drug Biotransformation in Children With Obstructive Sleep Apnea

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to determine the effect of chronic nighttime low oxygen saturations on selected body systems (liver) that break down drugs in children with obstructive sleep apnea syndrome (OSAS).

Detailed Description
-----------------
The purpose of this study is to determine the effect of chronic intermittent nocturnal hypoxia on selected hepatic drug-metabolizing enzyme systems in children with OSAS. The specific aims are to evaluate the activities of cytochrome P450 (CYP)1A2, N-acetyltransferase-2 (NAT-2), xanthine oxidase (XO)and CYP2D6 in children with OSAS and to determine the effect of OSAS treatment on the activities of these enzyme systems.

Official Title
-----------------
Effect of Chronic Intermittent Nocturnal Hypoxia on Hepatic Drug Biotransformation in Children With Obstructive Sleep Apnea

Conditions
-----------------
Sleep Apnea

Intervention / Treatment
-----------------
* Drug: Dextromethorphan
* Drug: Caffeine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children ages 4 to 16 years with suspected uncomplicated OSAS Exclusion Criteria: Children with complicated OSAS (craniofacial abnormalities, neuromuscular disorders) Children who are receiving medications known to induce or inhibit hepatic CYP1A2, NAT-2, XO, CYP2D6 or CYP3A4 activity Children who are exposed to second hand smoke for greater than 8 hours per day. Children with hypersensitivity to caffeine or dextromethorphan Children who are receiving corticosteroids or thyroid hormone

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 16 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Children with OSAS identified via sleep study | Drug: Dextromethorphan<br>* 0.5 mg/kg (maximum 30 mg)<br>Drug: Caffeine<br>* Administered as 4 ounces of Coca-Cola<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caffeine urinary molar ratio |  | Pre and post T&A | 
| Dextromethorphan urinary molar ratio |  | Pre and post T&A | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sleep apnea, phenotyping, cytochrome P450, drug metabolism, child
Clinical Study of New Urine Collection Bag for Infants.

Study Overview
=================
Brief Summary
-----------------
To determine whether a new urine collection bag for infants produces a reliable urine sample for culturing in respect of contamination rate with skin bacteria.

Conditions
-----------------
Urinary Tract Infection

Intervention / Treatment
-----------------
* Device: Urine collection bag for infants


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy children. Exclusion Criteria: Current infection of any kind. History of urinary tract infection.

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 3 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Urine collection bag for infants|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |