linjc16/ctgov huggingface dataset:
Inferior Alveolar Nerve Lateralization With Simultaneous Implant Placement Versus the Use of Short Dental Implants

Study Overview
=================
Brief Summary
-----------------
Assess the long term stability of short dental implants in comparison to standard implants inserted simultaneously with inferior alveolar nerve lateralization.

Official Title
-----------------
Inferior Alveolar Nerve Lateralization With Simultaneous Implant Placement Versus the Use of Short Dental Implants

Conditions
-----------------
Primary Stability of the Implants, Marginal Bone Loss

Intervention / Treatment
-----------------
* Procedure: Using short dental implant
* Procedure: Inferior alveolar nerve lateralization with simultaneous implant placement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients with edentulous posterior mandible. Both sexes. No intraoral soft and hard tissue pathology. No systemic condition that contraindicate implant placement. Residual alveolar bone width longer than 6 mm height (7-9 mm). Exclusion Criteria: Presence of fenestrations or dehiscence of the residual ridge. Heavy smokers more than 20 cigarettes per day .(24) Patients with systemic disease that may affect normal healing. Psychiatric problems Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site.

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Inferior alveolar nerve lateralization with implant placement<br> | Procedure: Inferior alveolar nerve lateralization with simultaneous implant placement<br>* Inferior alveolar nerve lateralization with simultaneous implant placement in atrophic posterior mandible.<br>|
| Experimental: Using short dental implant with atrophic mandible<br> | Procedure: Using short dental implant<br>* Using short dental implant for patients with atrophic posterior mandible.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary stability | measuring the primary stability using the osstel | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Marginal bone loss | measuring the marginal bone loss by using CBCT | 3 months |
Expression of Tuberculosis in the Lung

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess lung immune responses in patients with active pulmonary tuberculosis (TB) and in healthy control persons who are exposed to Mycobacterium tuberculosis in households of patients with TB or who are unexposed.

Detailed Description
-----------------
BACKGROUND: M. tuberculosis infects a third of the world's population, and TB is the leading cause of morbidity and mortality due to a single infectious agent. However, only 5% to 10% of M. tuberculosis-infected subjects without an underlying immunodeficiency develop disease during their lifetimes. Therefore protective immunity is induced in the majority of subjects. Understanding correlates of protection against M. tuberculosis in humans is needed to better direct efforts in the development of antituberculosis vaccines. DESIGN NARRATIVE: Patients are treated according to good clinical practice; however, no study medications are given as part of the research study. This study involves a one-time bronchoalveolar lavage and venipuncture to obtain immune cells for laboratory studies of immune responses.

Official Title
-----------------
Expression of Tuberculosis in the Lung

Conditions
-----------------
Tuberculosis

Intervention / Treatment
-----------------
* Other: Bronchoalveolar lavages and venipunctures only


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: TB patients who are 18 to 65 years old Clinical and radiographic signs and symptoms consistent with pulmonary TB Start date of antituberculous chemotherapy less than 10 days prior to procedures Sputum smear positive for acid fast bacilli Drug-sensitive, culture-confirmed growth of M. tuberculosis from sputum Willing to provide informed consent for participation in bronchoalveolar lavage and venipuncture studies Exclusion Criteria: TB patients who have HIV-1 coinfection History of any chronic medical condition requiring daily medication (including diabetes mellitus, hypertension, chronic infections, renal or cardiac failure, and peptic ulcer disease) History of asthma or upper or lower respiratory tract infection within 2 months of the study Hemoglobin level less than 10g/dl

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Bronchoalveolar lavages and venipunctures only|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary immune responses associated with resistance and susceptibility to Mycobacterium tuberculosis infection (measured at baseline) |  | one week |
Low Carb vs Normal Carb in Pregnancy

Study Overview
=================
Brief Summary
-----------------
The overall purpose of this intervention study is to examine whether low-carbohydrate dietary intervention will prevent the development of gestational diabetes mellitus (GDM) in high-risk pregnant women. The results of this study should help further our understanding of how pregnant women can help prevent gestational diabetes mellitus. We hypothesize that a lower carbohydrate diet will prevent the development of GDM.

Official Title
-----------------
Bump to Baby Study

Conditions
-----------------
Gestational Diabetes

Intervention / Treatment
-----------------
* Other: 100 g carbs
* Other: MyPlate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 - 40 years old BMI > 30 and/or history of gestational diabetes mellitus Currently in first trimester of pregnancy with single fetus (e.g. not twins, triplets, etc.) Newborns of current participants Exclusion Criteria: Diabetes (types 1 and 2) History of major chronic disease or blood clotting disorders (e.g., cancer, heart disease, kidney disease, hypertension) Known fetal anomaly History of eating disorders Current use of medications that affect appetite or insulin secretion/sensitivity (e.g. stimulants) Current use of illegal substances, antipsychotic or opioid substitution medications, alcohol, or tobacco

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 100 g carbs<br>100 grams of carbohydrate allowance for the day | Other: 100 g carbs<br>* Participants will be assigned a diet of 100g carbs max for the day<br>|
| Active Comparator: MyPlate<br>Carbohydrate suggestions based on standard MyPlate. 45-65% kcal intake from carbs. | Other: MyPlate<br>* 40-65% of daily intake is from carbohydrates<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Birth Outcome Questionnaire | Upon delivery of the baby, a birth outcome questionnaire will be collected which includes questions about the delivery and birth of the baby and a question about gestational diabetes. The answer to gestational diabetes or not will be the measure for the outcome. | 24 months |
Prevention of Acute Mountain Sickness by Intermittent Hypoxia

Study Overview
=================
Brief Summary
-----------------
Acclimatization by mountaineering prior to high altitude sojourns have shown to be effective in prevention of acute mountain sickness (AMS). The aim of this study is to investigate whether intermittent exposure to normobaric hypoxia during sleep is also effective to prevent AMS.

Official Title
-----------------
Prevention of Acute Mountain Sickness by Sleeping at Simulated Altitude (Normobaric Hypoxia)

Conditions
-----------------
Acute Mountain Sickness

Intervention / Treatment
-----------------
* Other: Hypoxic Exposure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy Exclusion Criteria: Altitude exposure above 2000 m 8 weeks prior or during the study

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Normoxia<br>Sleeping in normoxia for 14 nights prior to one night at 4500 m | |
| Experimental: Hypoxia<br>Sleeping in normobaric hypoxia for 14 nights at altitudes from 2500 - 3300 m prior to one night at 4500 m | Other: Hypoxic Exposure<br>* Sleeping in normobaric hypoxia for 14 nights at altitudes from 2500 - 3300 m prior to one night at 4500 m<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of acute mountain sickness |  | during one night at 4500 m | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep quality |  | during one night at altitude | 
| ventilatory acclimatization |  | during one night at altitude | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acute mountain sickness, intermittent hypoxia, acclimatization
Effect of N-Acetylcysteine (NAC) on Creatinine in Chronic Kidney Disease

Study Overview
=================
Brief Summary
-----------------
N-acetylcysteine is used to reduce the risk of injury to the kidney after the administration of contrast dye. The mechanism and effectiveness of this intervention is not substantiated in the literature. The investigators hypothesize that serum creatinine will be lower in patients who receive NAC compared to those who receive the placebo but serum cystatin C will not change in patients who receive NAC compared to those who receive the placebo. Also urine creatinine will increase after the administration of NAC compared to before the administration of NAC.

Official Title
-----------------
Randomized Controlled Trial Examining the Effect of N-Acetylcysteine on Serum Creatinine in Patients With Stage 3 Chronic Kidney Disease

Conditions
-----------------
Chronic Kidney Disease

Intervention / Treatment
-----------------
* Drug: N-acetylcysteine
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with an eGFR between 30-60 ml/min calculated using last available creatinine and patient weight. Age > 18 No known allergies to or adverse effects from NAC No known scheduled radio-contrast procedures No medications known to affect creatinine secretion

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>N-acetylcysteine 1200 mg twice daily x 48 hours | Drug: N-acetylcysteine<br>* N-acetylcysteine 1200 mg twice daily x 48 hours<br>|
| Placebo Comparator: 2<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24 hour creatinine clearance, estimated glomerular filtration rate (eGFR), proteinuria and cystatin C |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
proteinuria, N-acetylcysteine, Chronic kidney disease, eGFR, Cystatin C, Stage 3 chronic kidney disease
A Phase 1 Study of S-3304 in Patients With Solid Tumors

Study Overview
=================
Brief Summary
-----------------
To determine the maximum tolerated dose and safety profile of S-3304 in patients with biopsy accessible cancer who have failed previous therapy or to whom no standard therapies are available. To determine the pharmacokinetic profile of S-3304 in this patient population

Official Title
-----------------
A Phase 1 Study of S-3304 in Patients With Solid Tumors

Conditions
-----------------
Solid Tumors

Intervention / Treatment
-----------------
* Drug: S-3304


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Biopsy proven diagnosis of solid tumor(s) with biopsy accessible lesion(s) Must be able to tolerate oral medication Exclusion criteria Patients with other serious illnesses Patients who are receiving treatments

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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: Sequential Assignment
Interventional Model Description: Four dose levels were evaluated sequentially in separate groups of 6 to 8 patients: 1,600 mg/d (800 mg BID, Dose Level1 (DL1)), 3,200 mg/d (1,600 mg BID, DL2), 4,800 mg/d (2,400 mg BID, DL3), and 6,400 mg/d (3,200 mg BID, DL4). There was no intrapatient dose escalation.
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: S-3304|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
-----------------
neovascularization, matrix metalloproteinases, antiangiogenesis, type IV collagenases
Study of an Approved Drug With a Statin (a Medication That Lowers Cholesterol Levels) as Compared to Statin Therapy Alone in Patients With High Cholesterol (0653-040)

Study Overview
=================
Brief Summary
-----------------
The purpose of this 6-week study is to compare the reduction in specific levels of cholesterol in patients with high cholesterol.

Detailed Description
-----------------
The duration of treatment is 6 weeks.

Official Title
-----------------
A Multi-center, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, 6-Week Study to Evaluate the Efficacy and Safety of Ezetimibe 10 mg/Day When Added to Ongoing Therapy With a Statin Versus Statin Therapy Alone, in Patients With Hypercholesterolemia Who Have Not Reached National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) III Target LDL-Cholesterol Level

Conditions
-----------------
Hypercholesterolemia

Intervention / Treatment
-----------------
* Drug: MK0653, ezetimibe
* Drug: Comparator: statins


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: High cholesterol levels that are identified by specific laboratory values Exclusion Criteria: Active liver disease Any condition or situation which would interfere with participation

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0653, ezetimibe|nan|
|Drug: Comparator: statins|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change in LDL-C |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients reaching NCEP ATP III target LDL-C levels |  |  |
Evaluation of a Human Immunodeficiency Virus (HIV) Blood Screening Assay

Study Overview
=================
Brief Summary
-----------------
To test blood samples from volunteer donors of whole blood and blood components using a new investigational test that detects human immunodeficiency virus (HIV) infection. Results will be compared to the current HIV screening assay.

Conditions
-----------------
Healthy Donors, HIV Positive

Intervention / Treatment
-----------------
* Device: collection of follow-up sample based on PRISM HIV O Plus result


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy donors that have consented to study

Ages Eligible for Study
-----------------
Minimum Age: 17 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ABBOTT PRISM HIV O Plus assay for Specificity<br>All subjects will have their blood tested by the investigational HIV test. | Device: collection of follow-up sample based on PRISM HIV O Plus result<br>* Test blood samples with investigational HIV assay. If results are reactive, donors may be deferred and asked to return for a follow-up blood draw.<br>|
| No Intervention: ABBOTT PRISM HIV O Plus Assay for Sensitivity<br>Samples collected from specimen vendors or from specimen collection studies were tested by the investigational HIV assay. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PRISM HIV O Plus Test Data for Specificity | Negative HIV status was determined by the results of the HIV-1/HIV-2 comparator assay and HIV-1 qualitatitve RNA. | 12 months | 
| PRISM HIV O Plus Test Data for Sensitivity | Final HIV status was determined according to a supplemental testing algorithm for specimens positive by the investigational assay. Supplemental testing involved HIV-1 Western blot, HIV-2 EIA, HIV-2 Western blot and HIV-1 ribonucleic acid (RNA). | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
healthy donors, HIV positives
Compassionate Use of Dupilumab

Study Overview
=================
Brief Summary
-----------------
Provide Compassionate Use of Dupilumab

Detailed Description
-----------------
Compassionate Use requests are only being considered in response to Individual Patient Investigational New Drug (IND) applications. Availability will depend on location.

Intervention / Treatment
-----------------
* Drug: Dupilumab


Participation Criteria
=================

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

Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Combining Genomics and Imageomics to Predict the Sensitivity of Neoadjuvant Pemetrexed and Cisplatin Chemotherapy in Patients With Lung Adenocarcinoma

Study Overview
=================
Brief Summary
-----------------
Combining genomics and imageomics to predict the sensitivity of neoadjuvant pemetrexed and cisplatin chemotherapy in patients with lung adenocarcinoma

Official Title
-----------------
Combining Genomics and Imageomics to Predict the Sensitivity of Neoadjuvant Pemetrexed and Cisplatin Chemotherapy in Patients With Lung Adenocarcinoma

Conditions
-----------------
Sensitivity

Intervention / Treatment
-----------------
* Other: Neoadjuvant pemetrexed and cisplatin chemotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Aged between 18 and 75 years; 2. Lung adenocarcinoma; 3. The patient is able to receive neoadjuvant pemetrexed and cisplatin chemotherapy 4 .The patient is able to understand and comply with the study and has provided written informed consent. Exclusion Criteria: 1. Patients with a history of lung surgery; 2. Postoperative pathology showed non-primary lung cancer; 3. Patients with a history of other tumors; 4. Patients with severe complications (coronary heart disease, valvular heart disease, end-stage renal disease, severe liver cirrhosis); 5. Unable to cooperate with the researchers because of dementia or cognitive decline 6. Other situations that are not in conformity with the standards and requirements of this trial.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| neoadjuvant pemetrexed and cisplatin chemotherapy in patients with lung adenocarcinoma<br>neoadjuvant pemetrexed and cisplatin chemotherapy in patients with lung adenocarcinoma | Other: Neoadjuvant pemetrexed and cisplatin chemotherapy<br>* neoadjuvant pemetrexed and cisplatin chemotherapy in patients with lung adenocarcinoma<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor Regression Grade |  | 1-2 Weeks after enrollment (after Surgery) |