linjc16/ctgov huggingface dataset:
Helicobacter Pylori Eradication With a New Sequential Treatment

Study Overview
=================
Brief Summary
-----------------
Eradication rates of Helicobacter pylori (H. pylori) with standard triple therapy are disappointing, and studies from several countries confirm this poor performance. The study aimed to assess the eradication rate of a new sequential treatment regimen compared with conventional triple therapy for the eradication of H. pylori infection.

Detailed Description
-----------------
One thousand and forty-nine dyspeptic patients were studied prospectively. H. pylori-infected patients were randomized to receive 10-day sequential therapy [rabeprazole (20 mg twice daily) plus amoxicillin (1 g twice daily) for the first 5 days, followed by rabeprazole (20 mg), clarithromycin (500 mg) and tinidazole (500 mg, all twice daily for the remaining 5 days] or standard 7-day therapy [corrected] [rabeprazole (20 mg), clarithromycin (500 mg) and amoxicillin (1 g), all twice daily]. H. pylori status was assessed by histology, rapid urease test and 13C-urea breath test at baseline and 6 weeks or more after completion of treatment.

Official Title
-----------------
High Eradication Rates of Helicobacter Pylori With a New Sequential Treatment

Conditions
-----------------
Helicobacter Pylori Infection, Non Ulcer Dyspepsia, Duodenal Ulcer, Gastric Ulcer, Chronic Active Gastritis, Gastritis

Intervention / Treatment
-----------------
* Drug: Sequential therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Presence of active H. pylori infection Age >18 years Exclusion Criteria: Allergy to drug administered Liver or kidney failure Pregnancy Previous treatment for H. pylori infection

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Sequential therapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Helicobacter pylori eradication rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance to therapy |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Helicobacter pylori, Eradication, Sequential therapy, Standard therapy
Statin-Intolerance Registry

Study Overview
=================
Brief Summary
-----------------
The Statin-Intolerance Registry will characterize the patient population suffering from statin-intolerance which is a frequent but incompletely understood patient condition with important clinical implications for atherosclerotic cardiovascular disease (ASCVD) prevention. Patients will be systematically and prospectively included and followed by the registry.

Detailed Description
-----------------
This non-interventional registry based on routine clinical practice will collect data under real-life conditions. The treatment of patients will not be changed by this study. Data on patient characteristics and the treatment history will be collected via questionnaires at study entree. Yearly follow up visits will re-assess the baseline parameters and document cardiovascular events. The data will be analyzed using descriptive statistics.

Official Title
-----------------
Statin-Intolerance Registry

Conditions
-----------------
Dyslipidemias

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with dyslipidemia and statin intolerance, defined as: Use of 2 or more statins and intolerance of these drugs in any dose or inability to tolerate dosage increasement beyond a maximum weekly dose of 70 mg atorvastatin, 140 mg Simvastatin, pravastatin, or lovastatin, 35 mg rosuvastatin, 280 mg of Fluvastatin and symptoms improve or disappear when statin is reduced in dosage or discontinued Participants are ≧ 18 years old Written declaration of consent is available The patient is cognitively, linguistically and organizationally capable to meet the study requirements. The possibility of 1 year follow-up is very likely. Exclusion Criteria: Use of any experimental or investigational drugs within 30 days prior to screening. An employee or contractor of the facility conducting the study, or a family member of the principal investigator, co-Investigator, or sponsor.

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 |
| --- | --- | --- |
| Number of treatment adjustments |  | 3 years | 
| Change in LDL cholesterol level |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in quality of life | by EQ-5D | 3 years | 
| Development of muscle symptoms over time that initially lead to discontinuation of statin therapy | based on the Statin-Associated Muscle Symptom Clinical Index (SAMS-CI) | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Statins, Muscle symptoms, Cardiovascular, Lipid Metabolism Disorders
Meditation and Hypnosis for Chronic Depressed Mood

Study Overview
=================
Brief Summary
-----------------
This study examined whether meditation or group psychotherapy including hypnosis plus education, compared to an educational control, would ameliorate long-term depressed mood.

Conditions
-----------------
Long Term Depressed Mood

Intervention / Treatment
-----------------
* Behavioral: meditation plus education
* Behavioral: group psychotherapy with hypnosis plus education
* Behavioral: education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Currently meeting DSM-IV criteria for a chronic depressive disorder, with the requirement that depressive symptoms had to have lasted for at least 2 years without a remission of 2 months or more. Being 18 years of age or older. Being sufficiently proficient in English to be able to participate in group therapy. Being able to attend weekly meetings at Stanford. Exclusion Criteria: Concurrent bipolar disorder or severe depressive disorder (this latter was determined in supervision for the SCID interviews). Presence or history of psychosis. A current primary diagnosis of panic disorder, generalized anxiety disorder, or PTSD. A current primary diagnosis of drug or alcohol dependency or abuse (within the last 3 months). Serious suicidal risk, as defined by: Current suicidality, i.e., beyond simple ideation (e.g., making threats or attempts; gathering means; has a plan); OR Serious prior attempts (bodily harm; gathered means; hospitalization). Has a significant medical condition that could interfere with participation in meditation/yoga. Current participation in psychotherapy or a meditation group. Has started (or changed level or type of) prescribed antidepressant medication or St. John's Wort in the previous 3 months.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: meditation plus education|nan|
|Behavioral: group psychotherapy with hypnosis plus education|nan|
|Behavioral: education|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Clonidine as Adjunct Therapy for the Treatment of Neonatal Abstinence Syndrome

Study Overview
=================
Brief Summary
-----------------
To test the hypothesis that the combination of the tincture of opium (DTO) and clonidine will be more effective in treating infants with neonatal abstinence syndrome (opioid withdrawal) than tincture of opium (DTO) alone.

Official Title
-----------------
Efficacy of Clonidine in the Treatment of Neonatal Abstinence Syndrome: A Prospective, Double Blind, Randomized Controlled Trial

Conditions
-----------------
Neonatal Abstinence Syndrome

Intervention / Treatment
-----------------
* Drug: Clonidine HCL


Participation Criteria
=================
Eligibility Criteria
-----------------
neonates born at gestational age of 35 weeks or greater neonates aged 0 to 14 days prenatally exposed to opioids severe NAS defined as 2 consecutive modified Finnegan Scores (MFS) > or = 9 Exclusion Criteria: < 35 weeks gestational age Intrauterine growth retardation defined as <5%tile of gestational age postnatal treatment with barbiturates or benzodiazepines, major congenital anomalies major concomitant medical illness requiring oxygen therapy, intravenous fluids or medications. breastfed infants

Ages Eligible for Study
-----------------
Maximum Age: 14 Days

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clonidine treatment<br>Infants intrauterine exposed to opioids (heroin or methadone) that demonstrate signs and symptoms of withdrawal with withdrawal scores (modified Finnegan score) greater than 9 on to consecutive scores taken 4 hours apart. | Drug: Clonidine HCL<br>* Duraclon 1 microgram/kg every 4 hours given p.o. as per algorithm<br>* Other names: Duraclon;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of treatment for neonatal abstinence syndrome |  | duration of the treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
infants, opioid withdrawal, abstinence syndrome, methadone, heroin
Study Comparing Two Different Methods of Treating Periodontal Disease

Study Overview
=================
Brief Summary
-----------------
The purposes of this study are to: compare the clinical effectiveness of a traditional and a medical model of periodontal therapy; and determine the value of the two approaches to periodontal therapy.

Detailed Description
-----------------
This application was developed to test the following hypothesis: A medical model of periodontal therapy, when compared to a traditional model, is as clinically effective, is more valuable, and can be realistically implemented in clinical practice. To accomplish this task a prospective, blinded, community based, cohort trial will be carried out. Two analytical techniques will be employed to compare the outcomes of periodontal therapy: clinical effectiveness and value. The two primary outcome variables for assessing clinical effectiveness will be clinician centered (attachment level) and patient centered (quality of life). The key outcome variable for value determination is cost of care. Value is then determined by dividing the outcome by the cost of care. Thus a similar outcome at reduced cost increases value. This facilitates calculating cost-effectiveness and cost-utility of care, preparing decision analysis trees, and carrying out sensitivity analysis. There are two significant reasons for testing a medical model of care. If the hypothesis is correct: this would increase access to periodontal care; and it would offer a cost-effective method to treat periodontal infections that are correlated with systemic health problems. These points argue for a direct comparison of the medical and traditional models of care.

Official Title
-----------------
Outcomes of Traditional and Medical Models of Periodontal Therapy

Conditions
-----------------
Periodontal Diseases

Intervention / Treatment
-----------------
* Procedure: Periodontal Treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >/= 4 or more periodontally involved teeth as defined by pocket depth of >/= 6mm. >/= 14 teeth. > 18 years of age. Reside in the greater Boston area. Exclusion Criteria: Those patients requiring prophylactic antibiotic for dental treatment.

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Periodontal Treatment|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical attachment loss |  |  | 
| Quality of life |  |  | 
| Tooth loss |  |  | 
| Plaque accumulation |  |  | 
| Suppuration |  |  | 
| Bleeding on probing |  |  |
Adult Asthmatics and Acid Reflux

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the efficacy and safety of Nexium in the treatment of subjects with persistent asthma believed to have acid reflux as a contributory factor to control of their asthma.

Official Title
-----------------
A Randomized, Double-Blind, Parallel Group Multicenter Efficacy and Safety Phase IIB Pilot Study of Esomeprazole 40mg Bid Versus Placebo Bid in Adult Asthmatics Treated for 4 Months

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: Esomeprazole
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of asthma Forced Expiratory Volume and Peak Expiratory Flow as defined by the protocol Daily use of inhaled GCS and/or leukotriene pathway modifier for greater than 3 months. Severe heartburn 3 days/week during the run-in period. Exclusion Criteria: Subjects with a history of 3 sinus infections treated with antibiotics in the year prior to Visit 1. Any other significant disease or pathology judged to be clinically significant by the investigator

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Esomeprazole<br>* 40mg twice a day<br>* Other names: Nexium;|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* 40mg twice a day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect on asthma symptoms as measured by changes in Peak Expiratory Flow morning & evening, Forced Expiratory Volume and asthma symptom scores |  | 4 weekly | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety as assessed by adverse event recording and clinical and laboratory measurements. |  | 4 weekly | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma, Acid Reflux, Nexium, Esomeprazole
Probiotics to Improve Women's Health

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is explore the effect of probiotics on plasma lipopolysaccharides (LPS) concentrations, as well as insulin and glucose levels, in obese women prior to and after dietary challenges (high carbohydrate meal, high fat meal).

Official Title
-----------------
Probiotics to Improve Women's Health

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

Intervention / Treatment
-----------------
* Dietary Supplement: Probiotics


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI=30-40 kg/m2 Healthy, age 18 or older Not consuming yogurt or cultured milk regularly (</= 1x/wk) or any probiotic supplement Exclusion Criteria: Medical conditions or medications that may affect metabolism as determined by the PI.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: No groups<br> | Dietary Supplement: Probiotics<br>* Probiotics once a day for three weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma LPS concentrations |  | five weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose concentrations |  | five weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
healthy, obese, women
Rituximab Desensitization Therapy for Patients on the Waiting List for Kidney Transplant

Study Overview
=================
Brief Summary
-----------------
This is a study of patients who have a high risk of kidney rejection before kidney transplant. The hypothesis is that treatment with a medication called rituximab will make it possible for them to receive a kidney transplant from a donor who previously did not present a good match.

Official Title
-----------------
Multicenter Trial Using Multi-dose Rituximab as Induction and Desensitization Therapy for Patients on the Waiting List for Kidney Transplant With a Positive Donor Specific Crossmatch to a Living Donor

Conditions
-----------------
End Stage Renal Disease

Intervention / Treatment
-----------------
* Drug: rituximab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Active status on a kidney transplant waiting list with positive cross match against a living donor Exclusion Criteria: Receipt of a live vaccine within 4 weeks prior to randomization Previous Treatment with Rituximab

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: rituximab|Rituximab 375mg/m2 IV weekly times 4 weeks|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conversion of a positive donor specific cross-match to a living donor to a negative cross-match thereby allowing successful transplantation. |  | assess 4 weeks after Rituximab treatment completed | 
| Transplant success or failure following the desensitization protocol. |  | ongoing assessment for 2 years after transplant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in incidence of humoral rejection to less than 50% at 1 year. |  | assess 1 year after transplant | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
transplant, desensitization, kidney transplant
How Participants Behave and Respond on Their Own After Completing a 2-year Intervention of Calorie Restriction

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to gain knowledge about how participants behave and respond on their own after completing a 2-year intervention of calorie restriction.

Detailed Description
-----------------
You will not be assigned to any particular group during the Follow-Up Study. In the Follow-Up study there is no diet intervention. You will not be asked to follow a calorie-restricted diet or any other diet. Month 3 and Month 6 (Outpatient Visits)following procedures performed: Blood pressure, heart rate, temperature, Weight & Waist Measurement Medication and medical history Blood draw (approximately ½ cup) DEXA and QuickScan Psychological assessment questionnaires reviewed for completeness Body Acceptability Morph Test (BAM) Review of 7-day food diary Month 12 and Month 24 (Outpatient Visits) procedures performed: Collection of 4 urine samples Dosing with doubly labeled water (DLW) DEXA and QuickScan Eat breakfast and lunch Receive 7-day food diary Psychological assessment questionnaires Body Acceptability Morph Test (BAM) Fourteen days after Month 12 and Month 24 (Overnight Inpatient Visits) following procedures performed: Collection of 2 urine samples Blood pressure, heart rate, temperature, Weight & Waist Measurement Blood draw (approximately ½ cup) Medication and medical history Review of 7-day food diary Metabolic Chamber Resting Metabolic Rate (RMR)

Official Title
-----------------
The Proposed Study Entails a Follow-up of All the Completers for 2 Years With Visits Timed 3, 6, 12 and 24 Months After Completion of the 2-year CALERIE II Intervention.

Conditions
-----------------
Excessive Diet Restriction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: You may qualify to participate in this study only if you completed the CALERIE II study at Pennington Biomedical Research Center. Exclusion Criteria: If you were not a participant in CALERIE II at Pennington Biomedical Research Center, you are ineligible.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 50 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 |
| --- | --- | --- |
| Calorie Restriction | The purpose of this study is to gain knowledge about how participants behave and respond on their own after completing a 2-year intervention of calorie restriction. | 2-year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CALERIE II Follow-up