linjc16/ctgov huggingface dataset:
Immuno 1: Immune Reconstitution Following Conventional or High-Dose Chemotherapy With Stem Cell Transplant

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to conduct an analysis of the influences of conventional chemotherapy high-dose chemotherapy followed by autologous stem cell transplant high-dose chemotherapy followed by allogeneic stem cell transplant on the recovery of the immune system. Detailed analysis will help to better understand the pathways of recovery of the immune system following chemotherapy as well as the pathways of recovery of the immune system following autologous or allogeneic stem cell transplantation.

Detailed Description
-----------------
Detailed analysis will be performed at preselected time points following therapy by standard flow cytometry in combination with intracellular cytokine/antigen staining spectratype analysis TREC assays

Official Title
-----------------
Prospective Analysis of the Patterns of Immune Reconstitution Following Conventional or High-Dose Chemotherapy With Autologous/Allogeneic Stem Cell Transplant

Conditions
-----------------
Leukemia, Medulloblastoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute leukemia treated according to current ALL-BFM 2002 protocol Solid tumor treated according to current GPOH-protocol Medulloblastoma treated according to HIT-2000 protocol High-dose chemotherapy followed by autologous stem cell transplantation High-dose chemotherapy followed by allogeneic stem cell transplantation Written consent according to our institutional guidelines Exclusion Criteria: No written consent

Ages Eligible for Study
-----------------
Minimum Age: 0 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prospective analysis of immune function,, spectratype, immunoscope, TREC analysis, solid tumor
Study of Endothelial Keratoplasty Outcomes

Study Overview
=================
Brief Summary
-----------------
Endothelial keratoplasty is a cornea-sparing transplant technique that replaces only the diseased endothelial cell layer of the patient's cornea. This technique offers many advantages compared with traditional full-thickness cornea transplants. Patients experience minimal change in glasses prescription and usually recover useful vision within weeks. Visual fluctuations are minimal during the healing process. The patient's cornea remains structurally intact and is more resistant to injury. Endothelial keratoplasty is undergoing rapid and widespread adoption. Between 2005 and 2007, the number of corneas placed by US eye banks for endothelial keratoplasty increased ten-fold (2007 Eye Bank Association of America Annual Report). However, the procedure is less than 10 years old, and little is known about long term outcomes. Endothelial keratoplasty candidates at our center are invited to participate in an open enrollment, prospective study of the long-term outcomes of this procedure.

Official Title
-----------------
Open-enrollment, Prospective Study of Endothelial Keratoplasty Outcomes

Conditions
-----------------
Fuchs' Endothelial Corneal Dystrophy, Bullous Keratopathy, Iridocorneal Endothelial Syndrome, Posterior Polymorphous Dystrophy

Intervention / Treatment
-----------------
* Procedure: endothelial keratoplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female aged 18 or older Scheduled to undergo endothelial keratoplasty Able to provide written informed consent. Exclusion Criteria: Age less than 18 years

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Treatment<br>Endothelial keratoplasty procedure is performed. | Procedure: endothelial keratoplasty<br>* Endothelial keratoplasty is surgical replacement of the corneal endothelial cell layer (the cell layer lining the inner surface of the cornea).<br>* Other names: DMEK;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity |  | 1, 3, 6, and 12 months and annually | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial cell density |  | 6 months, 12 months and annually | 
| Intraocular pressure |  | 1, 3, 6, 12 months and annually | 
| Manifest refraction |  | 1, 3, 6, 12 months and annually | 
| corneal pachymetry |  | 1, 3, 6, 12 months and annually | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
failed penetrating keratoplasty
Post-marketing Surveillance Study With MicardisPlus® in Treatment of Morning Hypertension (Self-monitored by Patient)

Study Overview
=================
Brief Summary
-----------------
The purpose of the study was to examine the effect of six- to eight-week treatment with MicardisPlus® on blood pressure and the effect of patient self-monitoring on blood pressure control. In addition, the post-marketing surveillance study offered the possibility to obtain information about the influence on different laboratory parameters during treatment with MicardisPlus® from an unselected patient group under office conditions

Official Title
-----------------
Morning Hypertension and Patient Self-monitoring

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

Intervention / Treatment
-----------------
* Drug: MicardisPlus®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years Hypertension Exclusion Criteria: Age < 18 years

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Essential hypertension<br> | Drug: MicardisPlus®<br> <br> * Other names: Telmisartan in combination with hydrochlorothiazide;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in morning blood pressure (systolic and diastolic) |  | Pre-dose, up to 8 weeks after start of treatment | 
| Changes from baseline in laboratory values |  | Pre-dose, up to 8 weeks after start of treatment | 
| Investigator assessment of efficacy on a 5-point scale |  | Up to 8 weeks after start of treatment | 
| Investigator assessment of influence on metabolism on a 3-point scale |  | Up to 8 weeks after start of treatment | 
| Investigator assessment of tolerability on a 5-point scale |  | Up to 8 weeks after start of treatment | 
| Number of patients with adverse events |  | Up to 8 weeks |
BO and DO in Women With Cystocele Before and After Cystocele Repair

Study Overview
=================
Brief Summary
-----------------
The changes of lower urinary tract function after cystocele repair are important for perioperative consultation and management. Thus, the aim of this retrospective study was to evaluate the prevalence of bladder oversensitivity and detrusor overactivity in women with ≥ stage II cystocele and the changes of storage function after cystocele repair.

Detailed Description
-----------------
Bladder oversensitivity and detrusor overactivity are two important diagnosis of urodynamic study regarding storage function of bladder. Between November 2010 and October 2020, all women with ≥ stage II cystocele who visited the urogynecological department of a medical center for cystocele repair were reviewed. Those women who had complete data of preoperative and postoperative 3-month follow-up urodynamic data were excluded from this study. Bladder oversensitivity was diagnosed if the volume of strong desire was less than 300mL. Detrusor overactivity was defined as the occurrence of involuntary detrusor contractions during filling cytometry. STATA software was used for statistical analysis. Chi2 test, univariate and multivariable logistic regression tests were used for statistical analysis as appropriate. A p < 0.05 was considered as statistically significant.

Official Title
-----------------
Prevalence of Bladder Oversensitivity and Detrusor Overactivity in Women With Cystocele and the Changes of Storage Function After Cystocele Repair

Conditions
-----------------
Bladder Oversensitivity, Detrusor, Overactive

Intervention / Treatment
-----------------
* Procedure: Cystocele repair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with ≥ stage II cystocele Received cystocele repair Complete urodynamic study before and after surgery Exclusion Criteria: Recurrent cystocele after repairment Incomplete data Chronic infection

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 85 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| cystocele with repairment<br>women with ≥ stage II cystocele who visited the urogynecological department of a medical center for cystocele repair | Procedure: Cystocele repair<br>* Repair of endopelvic fascia and anterior colporrhaphy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bladder oversensitivity | the volume of strong desire was less than 300mL | November 2010 and October 2020 | 
| Detrusor overactivity | the occurrence of involuntary detrusor contractions during filling cytometry | November 2010 and October 2020 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bladder oversensitivity, Detrusor Overactivity, Cystocele
Effect Of Maraviroc On The Pharmacokinetics Of Digoxin

Study Overview
=================
Brief Summary
-----------------
This is an open labelled study to estimate the effect of maraviroc on the pharmacokinetics of digoxin, a probe for p-glycoprotein.

Official Title
-----------------
Open-Label, Fixed Sequence, Crossover Study To Estimate The Effect Of Multiple Dose Maraviroc On Single Dose Digoxin Pharmacokinetics In Healthy Subjects

Conditions
-----------------
Healthy, HIV Infections

Intervention / Treatment
-----------------
* Drug: Digoxin
* Drug: Digoxin
* Drug: Maraviroc


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and/or female subjects between the ages of 21 and 55 years, inclusive. Body Mass Index (BMI) of 17.5 to 25.5 kg/m2. Total body weight >50 kg (110 lbs). Exclusion Criteria: Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication. Subjects with an estimated creatinine clearance (CLcr) <80 ml/min. Pregnant or nursing females. Females of childbearing potential who are unwilling or unable to use an acceptable method of contraception as outlined in this protocol from at least 14 days prior to the first dose of study medication until completion of study.

Ages Eligible for Study
-----------------
Minimum Age: 21 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Digoxin<br> | Drug: Digoxin<br>* Oral Digoxin 0.25 mg single dose<br>|
| Experimental: Digoxin + Maraviroc<br> | Drug: Digoxin<br>* Oral Digoxin 0.25 mg single dose on Day 5<br>Drug: Maraviroc<br>* Oral Maraviroc 300 mg twice daily for 6 days<br>* Other names: Selzentry, Celsentri;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To estimate the effect of multiple dose maraviroc on the pharmacokinetics of digoxin. |  | 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the safety and tolerability of maraviroc and digoxin when co-administered. |  | 21 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Maraviroc, Digoxin, P-glycoprotein, Pharmacokinetics, Drug Interaction, HIV
Assisting Low-Income Families at Pediatric Well-Child Care Visits

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the impact and feasibility of a practice-based intervention on the discussion and referral of family psychosocial topics at well-child care visits at a medical home for low-income children.

Detailed Description
-----------------
Many low-income families have family psychosocial problems such as unemployment, housing difficulties, and food insecurity. Pediatric guidelines that pediatricians should be discussing and assisting these families. However, to date few routine do. The primary hypotheses for this study is that the WE CARE (Well-child care visit, Evaluation, Community resources, Advocacy, Referral, Education)intervention would increase the discussion and referral rates for family psychosocial problems at well-child care visits.

Official Title
-----------------
Enhancing a Medical Home for Vulnerable Children by Addressing Family Psychosocial Problems at Well-Child Care Visits: THE WE CARE Project

Conditions
-----------------
Low-income Children's Well-child Care Visit

Intervention / Treatment
-----------------
* Behavioral: Prompting (survey instrument/resources list) (behavior)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Caregivers of children aged 2 months to 10 years who present for well-child care visit at a pediatric clinic Exclusion Criteria: Non-English speaking Foster parents Previously enrolled parent No access to telephone
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Prompting (survey instrument/resources list) (behavior)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Discussion of family psychosocial problem |  |  | 
| Referral of family psychosocial problem |  |  | 
| Contacting community resources |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pediatrician, well-child care visit, low-income children, family psychosocial problem
Evaluation of the Effect of Narrowband UVB Versus Methotrexate on Serum TWEAK Level in Psoriasis

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate the effect of NB-UVB versus MTX on serum TWEAK level in psoriatic patients.

Official Title
-----------------
Evaluation of the Effect of Narrowband Ultraviolet B Versus Methotrexate on Serum TWEAK Level in Psoriasis

Conditions
-----------------
Psoriasis

Intervention / Treatment
-----------------
* Radiation: Narrowband ultraviolet B
* Drug: Methotrexate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with moderate to severe plaque psoriasis of any age and gender. Exclusion Criteria: History of psoriasis treatment with systemic and biological agents prior to the study for at least 3 months. Pregnancy and lactation. Infections Patients with chronic diseases: hepatic disorders, hematologic disease, chronic renal failure or cancer
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: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Narrowband ultraviolet B<br>Patients will receive 8 sessions of NB-UVB per month for 3 successive months | Radiation: Narrowband ultraviolet B<br>* Patients will receive 8 sessions of NB-UVB per month for 3 successive months<br>* Other names: NB-UVB;|
| Active Comparator: Methotrexate group<br>Patients will receive 25 mg/1ml of methotrexate vial per week for 3 successive months | Drug: Methotrexate<br>* Patients will receive 25 mg/1ml of methotrexate vial per week for 3 successive months<br>* Other names: MTX;|
| No Intervention: healthy individuals as control group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum TWEAK in psoriasis | Measurement of tumor necrosis factor weak inducer of apoptosis (TWEAK) pg/ml; in psoriatic patients before and after treatment with NB-UVB versus MTX in comparison with healthy individuals, using ELISA (enzyme-linked immunosorbent assay). | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment of psoriasis | Clinical evaluation: Assessment of disease severity will be performed by using psoriasis area severity index (PASI score) before and after treatment with NB-UVB in comparison with MTX. Patients will be photographed at baseline and after 3 months of regular treatment by using high resolution digital camera canon EOS 1300D 18 megapixels (made in taiwan), photography will be done in standard light and distance. | 3 months |
Patient-reported Outcome Questionnaire for Women With Metastatic Breast Cancer

Study Overview
=================
Brief Summary
-----------------
The goal of the study is to understand the meaning of progression-free survival for women with metastatic breast cancer and to use this understanding to create and distribute a new questionnaire to assess the effect progression has on a woman's functioning and well-being.

Detailed Description
-----------------
This study is being conducted in three stages. Stages I and II are complete. Participation in Stage III requires the completion of an online survey. The survey may be accessed at the following link: https://www.surveymonkey.com/s/mbc3survey Compensation options for eligible participants are listed at the end of the survey. Eligibility will be confirmed in follow-up call/email by study staff.

Official Title
-----------------
Development and Implementation of a Patient-reported Outcome Questionnaire to Assess the Value of Progression-free Survival for Women With Metastatic Breast Cancer.

Conditions
-----------------
Metastatic Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female Age 18 and older Clinical diagnosis of metastatic breast cancer U.S. resident Able to speak and read English Willing to sign and informed consent Willing to self-administer one online questionnaire that will take approximately 15 minutes to complete

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

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

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Women, Stage IV, Metastatic, Breast Cancer, Progressed, Progression
Weight Loss and Exercise in Physically Limited Obese Elderly Subjects

Study Overview
=================
Brief Summary
-----------------
The overall purpose of this research is to determine the effect of weight loss and physical training on quality of life, physical function, metabolism, bone strength, body fat and muscle mass.

Detailed Description
-----------------
Obesity causes serious medical complications and impairs quality of life. Moreover, in elderly persons, obesity can lead to frailty because of decreased strength, joint function, balance and mobility associated with aging. The primary objective of this study is to evaluate the effect of weight loss and physical training on physical function, body composition, metabolism and quality of life in frail, obese elderly men and women. Subjects are randomized to either control or 10% weight loss plus physical training.

Official Title
-----------------
Effect of Weight Loss and Physical Training on Musculoskeletal Status, Physical Function, and Quality-of-Life in Physically Limited, Obese, Elderly Subjects

Conditions
-----------------
Obesity, Frailty, Elderly

Intervention / Treatment
-----------------
* Behavioral: diet, exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Obese (BMI 30 or greater) elderly (age 65 years or older) Frailty Exclusion Criteria: Major chronic disease or any condition that would interfere with exercise or dietary restriction, in which exercise or dietary restriction are contraindicated, or that would interfere with interpretation of results. Examples include cardiopulmonary disease, unstable disease, severe orthopedic or neuromuscular impairments, dementia, history of malignancy during the past 5 yr, current use of bone acting drugs.

Ages Eligible for Study
-----------------
Minimum Age: 65 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: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: diet, exercise|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| physical function and body composition |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life, metabolic markers |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obesity, Aging, Frailty, exercise, weight loss