linjc16/ctgov huggingface dataset:
Influence of Alfacalcidol on Falls in Osteopenic/Osteoporotic Postmenopausal Women (ALFA Study)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effect of alfacalcidol 1 µg daily on the number of fallers in postmenopausal, alendronate-treated, osteopenic or osteoporotic women. primary outcome = number of fallers (patients with at least one locomotor fall incl.mixed falls)

Official Title
-----------------
Influence of Alfacalcidol on Falls in Elderly Postmenopausal, Alendronate-Treated, Osteopenic/Osteoporotic Women With High Risk of Falls

Conditions
-----------------
Osteoporosis, Postmenopausal, Osteopenia, Falls

Intervention / Treatment
-----------------
* Drug: alfacalcidol
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age > 65 years postmenopausal women osteopenia/osteoporosis as defined by WHO criteria Exclusion Criteria: Neoplasm or other severe diseases with life expectancy less than one year or expectation of rapid worsening within one year Chronic inflammatory rheumatoid disease Arthritis with continuous pain and influence on locomotion Inflammatory or metabolic bone disease, excluding osteoporosis. Subjects with antiosteoporotic medications who are not willing to switch over to alendronate treatment. Estrogen treatment can be continued 25-OH-Vitamin D3 < 12 ng/ml (12 ng/ml = 30 mmol/L) Systemic corticosteroid treatments of more than one month within previous 12 months Intolerability for alfacalcidol Hypercalcaemia (>2,7 mmol/l) Milk alkali syndrome Uncorrected, severe visual impairments Creatinin > 2.5 mg/dl (>220 µmol/L)

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

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

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

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 |
| --- | --- |
| Experimental: 1<br>alfacalcidol 1µg/d | Drug: alfacalcidol<br>* alfacalcidol 1 µg once daily, oral, for 3 years<br>|
| Placebo Comparator: 2<br>placebo | Drug: placebo<br>* placebo once daily, oral, for 3 years<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| primary outcome: number of fallers (patients with at least one locomotor fall incl.mixed falls) |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| secondary outcome: number of falls (locomotor falls, incl.mixed falls), all falls/fallers, neuromuscular parameters, BMD, biochemical parameters of calcium and bone metabolism; cognition and moods; muscle biopsies |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
osteoporosis, frailty, falls
Safety and Effectiveness of Giving L-743,872 to Patients With Thrush That Has Not Been Cured With Fluconazole

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see if it is safe and effective to give L-743,872 to patients with thrush, an AIDS-related yeast infection of the mouth, that has not been cured with fluconazole treatment.

Detailed Description
-----------------
Patients are randomized to treatment with L-743,872 at one of two doses administered intravenously by a peripheral line once-daily. Patients are treated for 48 hours beyond resolution of symptoms or for a maximum of 14 days. Each patient is expected to complete the study, including the 14-day follow-up, within approximately 4 weeks. A physical examination is performed daily during the antifungal treatment period and at the follow-up visits 7 and 14 days post-therapy. Laboratory tests of blood and urine for safety are performed every three days during treatment and at follow-up 7 days post-therapy. Liver enzymes are drawn at the 14-day follow-up visit.

Official Title
-----------------
A Multiclinic, Double-Blind, Randomized, Dose-Comparison Study to Evaluate the Safety, Tolerability, and Efficacy of L-743,872 in the Treatment of Fluconazole-Unresponsive Oropharyngeal Candidiasis in Adults

Conditions
-----------------
Candidiasis, Oral, HIV Infections

Intervention / Treatment
-----------------
* Drug: L-743,872


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria You may be eligible for this study if you: Have thrush that has not responded to fluconazole treatment. Are 18-65 years old.

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: Treatment
Intervention Model: Parallel Assignment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: L-743,872|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
-----------------
AIDS-Related Opportunistic Infections, Dose-Response Relationship, Drug, Fluconazole, Antifungal Agents, Candidiasis, Oral, Pharyngeal Diseases, MK 0991
Tenofovir Monotherapy in Patients With Chronic Hepatitis B Patients Who Had Achieved Complete Viral Suppression on Lamivudine Plus Adefovir

Study Overview
=================
Brief Summary
-----------------
Little is known about efficacy of switching to tenofovir monotherapy for lam-resistant chronic hepatitis B patients who achieved a complete virological response to lamivudine plus adefovir. This study was to investigate the efficacy of switching to tenofovir monotherapy for lamivudine -resistant chronic hepatitis B patients with undetectable hepatitis B virus DNA while on lamivudine plus adefovir combination therapy

Official Title
-----------------
Investigation of Efficacy of Tenofovir Monotherapy in Comparison With Lamivudine Plus Adefovir in Patients With Chronic Hepatitis B Patients Who Had Achieved Complete Viral Suppression on Lamivudine Plus Adefovir Combination Therapy - Multicenter Randomized Open-label Controlled Trial

Conditions
-----------------
Proportion of Patients With a Sustained Virological Response (Serum HBV DNA <20 IU/mL) at Week 48

Intervention / Treatment
-----------------
* Drug: lamivudine plus adefovir combination
* Drug: Tenofovir Disoproxil Fumarate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HBsAg (+) for > 6 months age >19 years antiviral resistance to LAM (rtL180M and/or M204V/I) currently receiving LAM plus ADV for more than 12 months HBV DNA levels <20 IU/ml on two consecutive tests of 3-month interval Exclusion Criteria: Cr ≥1.5 mg/dL Evidence of decompensated liver disease Malignant neoplasm Coinfection with HIV, HCV

Ages Eligible for Study
-----------------
Minimum Age: 19 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: lamivudine adefovir<br> | Drug: lamivudine plus adefovir combination<br>* continuing lamivudine plus adefovir<br>|
| Experimental: tenofovir<br> | Drug: Tenofovir Disoproxil Fumarate<br>* switching to tenofovir<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SVR | Proportion of patients with a sustained virological response (serum HBV DNA <20 IU/mL) at week 48 | 48 WEEK |
Can Alternative Treatment Have an Impact on Cervical Dysplasia?

Study Overview
=================
Brief Summary
-----------------
In this study two questions will be answered: can mindfulness meditation help cell-changed on the cervix to disappear? can mindfulness meditation lower the psychological distress when women have abnormal cervical cancer screening results?

Detailed Description
-----------------
200 women, who have participated in cervical cancer screening and have mild dysplasia, will be randomized into two groups; an intervention group and a control group. The intervention group will be asked to do mindfulness meditation twice a week listening to instructions from a CD. 200 additional women having normal cervical screening results will also be included in the project.

Official Title
-----------------
Can Mindfulness Meditation Limit the Progression and/or Increase the Remission of Cervical Dysplasia?

Conditions
-----------------
Cervical Dysplasia

Intervention / Treatment
-----------------
* Behavioral: Mindfulness meditation
* Other: No meditation
* Other: Controls


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women aged 23-29 years Participated in cervical cancer screening Having mild dysplasia and normal screening results Exclusion Criteria: Women who have previously had dysplasia

Ages Eligible for Study
-----------------
Minimum Age: 23 Years
Maximum Age: 29 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mindfulness meditation<br>Women with mild dysplasia offered mindfulness meditation | Behavioral: Mindfulness meditation<br>* Mindfulness meditation<br>|
| Other: No meditation<br>Women with mild dysplasia offered health care services as usual | Other: No meditation<br>* Health care services as usual<br>|
| Other: Controls<br>Women with normal cervical cells | Other: Controls<br>* No intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The degree of cervical dysplasia |  | 6 months after screening | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychosocial consequences measured with the COS-CC questionnaire |  | 1 week, 3 and 9 months after screening | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Screening, Cervical cancer, Cervical dysplasia, Adverse psychosocial effects, Alternative treatment
Understanding Local Determinants of Cardiovascular Disease and Diabetes

Study Overview
=================
Brief Summary
-----------------
Cross-sectional survey of all adults residing in two defined geographical regions in urban Lilongwe and rural Karonga District. Participants were interviewed, had anthropometric measures taken, and had fasting blood specimens taken.

Official Title
-----------------
Understanding Local Determinants of Cardiovascular Disease and Diabetes to Inform Novel Interventional Strategies

Conditions
-----------------
Hypertension, Diabetes, Overweight and Obesity

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all adults over 18 self-identifying as normally resident in the pre-defined geographical areas Exclusion Criteria: None

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: No intervention|No intervention|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| What is the true burden of hypertension, diabetes, and hyperlipidaemia? | Prevalence of hypertension (BP <140/90 or self-report of antihypertensive use), diabetes (fasting blood glucose >7.0 or self-report history of diabetes), and hyperlipidaemia | By end of 2018 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| What is the prevalence of known risk factors - notably smoking, obesity, physical inactivity, alcohol, salt, and saturated fat intake? | Description of prevalence of known risk factors of hypertension, diabetes, and hyperlipidaemia. Dietary salt intake is estimated both by how long a defined quantity of salt is reported to last in a household on average, and from spot urine sodium specimens. | By end of 2020 | 
| Is infection, notably HIV infection or its therapy, associated with increased risk of NCDs? | Description of HIV infection and its therapy in relationship to hypertension, diabetes and hyperlipidaemia | By end of 2020 |
Nutritional Assessment Tool in Childhood Chronic Liver Disease

Study Overview
=================
Brief Summary
-----------------
Study Cohort: All Children (Age: 3 months- 18 years, corrected age upto 2 years for preterm children) with Chronic Liver Disease attending Pediatric Hepatology Out Patient Department/In Patient Department

Official Title
-----------------
Nutritional Assessment Tool in Childhood Chronic Liver Disease

Conditions
-----------------
Chronic Liver Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children from age of 3 months- 18 years (corrected age upto 2 years for preterm children) Chronic liver disease. Exclusion Criteria: Any metabolic or endocrinal diseases independently affecting nutritional status Refusal to give written informed consent to participate in the study

Ages Eligible for Study
-----------------
Minimum Age: 3 Months
Maximum 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 |
| --- | --- | --- |
| Reliability of SGNA versus nutritional status as assessed by standard anthropometric measures in children with chronic liver disease. | Nutritional status (well nourished, moderate or severe malnutrition) of a child with chronic liver disease as assessed by standard anthropometric measures (weight, height, mid arm circumference, Body mass index, triceps and subscapular skin fold thickness) will be compared to the results of nutritional assessment score as obtained by applying Subjective Global Nutritional Assessment (SGNA) proforma. | 2 years |
Use of Internet Mediated Walking Program and Pedometer in COPD

Study Overview
=================
Brief Summary
-----------------
Persons with COPD are randomized to pedometer versus pedometer plus Internet mediated website to promote walking and physical activity. Primary outcome is daily step counts. Intervention lasts 3 months.

Official Title
-----------------
Randomized Study of Use of Internet Mediated Walking Program and Pedometer in COPD

Conditions
-----------------
COPD

Intervention / Treatment
-----------------
* Behavioral: Internet mediated walking program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COPD, ability to walk, has Internet access Exclusion Criteria: COPD exacerbation in previous 4 weeks

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 90 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pedometer alone<br>pedometer | Behavioral: Internet mediated walking program<br> <br> |
| Experimental: Pedometer plus website<br>pedometer and website | Behavioral: Internet mediated walking program<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily Step Counts | measured by pedometer | pre and 3 months post |
Association Between Mother and Child Weight Gain: Statistical Methods With Validation

Study Overview
=================
Brief Summary
-----------------
Using retrospective data from the Vanderbilt University Medical Center electronic health record, the investigators will study the association between mother's weight / weight change before and during pregnancy and the development of childhood obesity up until 5 years of age.

Detailed Description
-----------------
The investigators are extracting de-identified retrospective data from the Vanderbilt University Medical Center electronic health record for mother-child pairs. From this data, the investigators will study the association between mother weight change during pregnancy and the risk of her child developing obesity during the first 5 years of life. Included mothers must have at least one weight measurement and at least one height measurement; they must have at least one child with weight/length measurements at birth and one additional same day height/weight measurement at or before 5 years of age.

Official Title
-----------------
Association Between Mother and Child Weight Gain: Statistical Methods With Validation

Conditions
-----------------
Obesity, Childhood

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mother-child pairs in the Vanderbilt University Medical Center (VUMC) electronic health record. The mothers must have at least one height measurement. The mothers must also have at least one weight measurement during pregnancy. The child must have birth length and weight measures and at least one same day height/weight measurement during their first 5 years of life.

Ages Eligible for Study
-----------------
Minimum Age: 0 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 |
| --- | --- |
| Mother-Child<br>Mothers who have delivered at VUMC and their children who are seen by Vanderbilt-affiliated physicians. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Obesity of the Child (in the Mother-child Pair) During the First 5 Years of the Child's Life | Obesity of the child is defined as having a BMI-by-age classification greater than the 95th percentile based on the US CDC percentiles. | first 5 years of child's life |
Influence of IPV on GOR in Infants From 0 to 12 Months.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether Intrapulmonary Percussive Ventilation ( airway clearance technique) provokes or aggravates gastro-oesophageal reflux in infants from 0 to 12 months.

Official Title
-----------------
Influence of Intrapulmonary Percussive Ventilation (IPV) on Gastro-oesophageal Reflux (GOR) in Infants From 0 to 12 Months.

Conditions
-----------------
Gastro-oesophageal Reflux

Intervention / Treatment
-----------------
* Device: Intrapulmonary Percussive Ventilation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: infants from 0 to 12 months impedance monitoring Exclusion Criteria: gestational age < 24w anti-reflux medication Nissen fundoplication no parental consent

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 12 Months

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: Intrapulmonary Percussive Ventilation<br>number of refluxes during 20 min of IPV ( rate : 300/min, p = 10cmH2O) at least 120 min after feeding | Device: Intrapulmonary Percussive Ventilation<br>* 20 min IPV freq 300/min, p 10cmH2O<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Refluxes | Every two hours after feeding, the number of refluxes during 20 minutes are measured. The mean number of refluxes during these periods were calculated and compared to the number of refluxes during 20 minutes of IPV | during 20 minutes of IPV compared to mean number of refluxes during 20 minutes. |
Pre-approval Single-patient Expanded Access for Ritlecitinib (PF-06651600)

Study Overview
=================
Brief Summary
-----------------
Provide pre-approval single patient Expanded Access (compassionate use) of Ritlecitinib for patients.

Detailed Description
-----------------
In Expanded Access, treating physicians are the Sponsors. Expanded Access requests from treating physicians may be submitted to www.pfizercares.com. Availability will depend on location and country.

Conditions
-----------------
Alopecia Areata

Intervention / Treatment
-----------------
* Drug: Ritlecitinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Must have ≥ 50% hair loss on scalp due to Alopecia Areata (AA) and be intolerant or have inadequate response to all commonly used AA therapies accessible in the country. Additional eligibility criteria may be required.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ritlecitinib|capsules|

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
-----------------
Alopecia Areata (AA), Alopecia, Patchy AA, Alopecia Universalis (AU), Alopecia Totalis (AT), Ophiasis, Eyelash Loss, Eyebrow Loss, Hair Loss