linjc16/ctgov huggingface dataset:
A Study of Motexafin Gadolinium for the Treatment of Chronic Lymphocytic Leukemia (CLL)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if the drug motexafin gadolinium will be an effective treatment for patients who have chronic lymphocytic leukemia (CLL) that has come back after treatment or that has stopped responding to treatment.

Official Title
-----------------
Phase II Trial of Motexafin Gadolinium (MGd) in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)

Conditions
-----------------
Leukemia, Leukemia, Lymphocytic, Chronic

Intervention / Treatment
-----------------
* Drug: Motexafin gadolinium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 18 years old Refractory or relapsed CLL ECOG performance status score of 0, 1, or 2 Each patient must sign a study-specific informed consent form Exclusion Criteria: Laboratory values of: Platelet count <30,000/uL AST or ALT >2 x the upper limit of normal (ULN) Total bilirubin >2 x ULN Creatinine >2.0 mg/dL Chemotherapy, radiation therapy, immunotherapy, systemic corticosteroids, or systemic biologic anticancer therapy within 21 days before beginning study treatment Women who are pregnant or lactating

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: Motexafin gadolinium|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
-----------------
CLL, chronic lymphocytic leukemia, relapsed chronic lymphocytic leukemia, refractory chronic lymphocytic leukemia, Leukemia, Motexafin gadolinium, Chronic leukemia, Lymphocytic leukemia, chronic
New Clinical Score for Deep Vein Thrombosis

Study Overview
=================
Brief Summary
-----------------
A new Clinical Score (CS) to rule out Deep Vein Thrombosis (DVT) has to be derived and internally validated (with bootstrap method), from patients suspected of DVT in Italy. Primary care physicians (general practitioners) in Lombardy will be instructed to inform patients suspected of DVT about this research and get in touch with the team to get details and, eventually, volunteer for the study. The CS includes categorical variables and a continuous variable: the differential leg skin temperature measured with a low-cost handheld infrared thermometer in object surface mode.

Official Title
-----------------
A New Clinical Score for Deep Vein Thrombosis: the Role of Differential Leg Skin Temperature Measured With Handheld Low-cost Infrared Thermometers.

Conditions
-----------------
Deep Vein Thrombosis

Intervention / Treatment
-----------------
* Diagnostic Test: temperature measurement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients suspected of deep vein thrombosis. Exclusion Criteria: under 18 years of age

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 |
| --- |
|Diagnostic Test: temperature measurement|Differential Leg Skin Temperature Measured With Handheld Low-cost Infrared Thermometers.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| presence of DVT |  | baseline |
Linezolid for the Treatment of Infections Caused by Methicillin Resistant Staphylococcus Aureus in Japan

Study Overview
=================
Brief Summary
-----------------
Use of linezolid in patients with methicillin-resistant Staphylococcus aureus infections in Japan

Official Title
-----------------
Linezolid (PNU-10766/PNU10766SS) in the Treatment of MRSA Infections in Patients Whose Conventional Therapy Has Failed, or Who Are Intolerant to Conventional Therapy; an Open-label, Multi-center Trial

Conditions
-----------------
Infections, Nosocomial

Intervention / Treatment
-----------------
* Drug: linezolid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: infection due to methicillin-resistant Staphylococcus aureus Exclusion Criteria: hypersensitivity to linezolid

Ages Eligible for Study
-----------------
Minimum Age: 16 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: linezolid|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolution of infection at the time of completion of therapy |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  |  |
C-Reactive Protein as a Predictor for Airway Hyper-Responsiveness

Study Overview
=================
Brief Summary
-----------------
Background: Increased serum high sensitivity C-reactive protein (hs-CRP) has been associated with airway inflammation in asthma and may serve as a surrogate marker for the presence of airway hyper-responsiveness (AHR) in this set-up. This study was designed to evaluate the predictive value of hs-CRP for AHR assessed by metacholine challenge test (MCT), in adults with suspected Asthma.

Official Title
-----------------
C-Reactive Protein as a Predictor for Airway Hyper-responsiveness

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

Intervention / Treatment
-----------------
* Other: blood sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: subjects that were referred to Metacholine challenge test Exclusion Criteria: age < 18

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: blood sampling|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A 2 Week Study of Topical KD7040 in the Treatment of Postherpetic Neuralgia (PHN)

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the safety and efficacy of 2 weeks of topical KD7040 versus placebo in the treatment of postherpetic neuralgia.

Conditions
-----------------
Postherpetic Neuralgia, Shingles, Herpes Zoster, Neuropathic Pain

Intervention / Treatment
-----------------
* Drug: KD7040 Topical Gel
* Drug: Placebo gel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female subjects ages 18-85 years Previous diagnosis of Shingles (Herpes Zoster) with pain persisting for at least 3 months, but not longer than 5 years, after healing of rash Subject with intact skin in the targeted treatment area Female subjects of childbearing potential must have a negative serum pregnancy test at screening, a negative urine human chorionic gonadotropin (hCG) test prior to randomization, and must use medically acceptable methods of birth control. All subjects must agree to take every precaution to ensure that pregnancy will not occur during the study. Subject must be willing and able to complete screening and study procedures as described int he protocol. Subject must voluntarily provide written Informed Consent prior to participation. Exclusion Criteria: Subjects with known hypersensitivity to KD7040 or methylparaben, or previous exposure to KD7040. Subjects pregnant, nursing or planning to become pregnant. Subjects who are immunocompromised or have clinically significant hematological abnormalities. Subjects with system dermatological conditions (e.g., psoriasis, atopic dermatitis) or impaired wound healing. Subjects who have had local anesthetic nerve blocks within 48 hours of study entry. Subjects having other sever pain which may confound assessment of PHN. Subjects who have serious, unstable, or clinically significant medical or psychological conditions, which, in the opinion of the Investigator(s) would compromise the subjects' participation in the study.

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: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KD7040 topical gel<br> | Drug: KD7040 Topical Gel<br>* KD7040 topical gel<br>|
| Placebo Comparator: Placebo gel<br> | Drug: Placebo gel<br>* Placebo gel<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Worst daily pain |  | Once daily | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average daily pain |  | Once daily |
Effect of Vitamin D on Everolimus Trough Concentrations Among Heart Transplanted Patients

Study Overview
=================
Brief Summary
-----------------
Vitamin D is part of the regular treatment regimen among patients after heart transplantation. Due to potential drug-drug interaction between vitamin D and everolmus, these patients are in increased risk for increased everolimus metabolism, potentially leading to under- immunosupression.

Detailed Description
-----------------
post heart transplantation patients treated with everolimus will be screened for vitamin D levels. Patients defined as deficient will be treated with vitamin D with close and intensive monitoring everolimus levels, adjusting oral daily dose to maintain therapeutic levels.

Official Title
-----------------
The Effect of Normalizing Vitamin D Concentrations on Everlomius Trough Concentrations

Conditions
-----------------
Vitamin D Deficiency

Intervention / Treatment
-----------------
* Dietary Supplement: Vitamin D


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Heart transplanted patients treated with everolimus Exclusion Criteria: -

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin D deficient<br>Vitamin D supplementation and close everolimus trough levels monitoring with oral dose adjustments | Dietary Supplement: Vitamin D<br>* Oral daily vitamin D<br>|
| No Intervention: No vitamin D deficiency<br>Regular and routine monitoring | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral daily everolimus dose change |  | 8 weeks |
24-hour Urinary Electrolyte Excretion in Chronic Kidney Disease

Study Overview
=================
Brief Summary
-----------------
Association between excretion pattern and development trajectory of urinary electrolytes (urine sodium, urine potassium, urine chlorine, urine magnesium, urine calcium, urine phosphorus, urine creatinine, urea, uric acid, urine glucose, urine protein, urine retinol) and adverse prognosis in patients with chronic kidney disease

Official Title
-----------------
24-hour Urinary Electrolyte Excretion and Renal Prognosis in Chronic Kidney Disease：a Retrospective Cohort Study

Conditions
-----------------
Chronic Kidney Diseases, Electrolyte Imbalance

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Our study is a retrospective cohort study. The study included patients with adult（Age≥18years）CKD who were hospitalized in the Department of Nephrology, First Medical Center of Chinese PLA General Hospital from January 2014 to July 2022. Patients with CKD who had one or more 24-hour urinary electrolyte excretion tests at intervals of more than three months were included in the subgroup analysis. Exclusion Criteria: Patients with hemodialysis therapy and urine volume less than 500ml were excluded.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- | --- |
| Kidney disease progression | eGFR decline > 50%; dialysis; kidney transplant | 2014.1.1-2022.7.31 | 
| Death | All cause death | 2014.1.1-2022.7.31 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular disease | myocardial infarction, angina pectoris, stable heart failure, peripheral artery disease , revascularization, cerebrovascular events | 2014.1.1-2022.7.31 |
Impact of a Childhood Obesity Intervention for African American Families

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the impact on body mass index (BMI) of a 5-session childhood obesity intervention for African American families among children aged 5-12 years. We hypothesize that children participating in the program will experience a reduction in BMI.

Official Title
-----------------
Impact of a Childhood Obesity Intervention for African American Families

Conditions
-----------------
Obesity, Overweight

Intervention / Treatment
-----------------
* Behavioral: Active and Healthy Families


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI greater than or equal to the 85th percentile for age and sex Attends an elementary school in the Pittsburg Unified School District in California Parent of child meeting above criteria Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 12 Years

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: Family group sessions<br>Active and Healthy Families | Behavioral: Active and Healthy Families<br>* A pediatric overweight/obesity intervention delivered through five bi-weekly family-based group sessions.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body mass index (BMI) | Change in BMI will be calculated from measured height and weight | Baseline and at week 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | Change will be calculated based on measured blood pressure | Baseline and at week 10 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Schools, Pediatrics, Obesity, Overweight, Intervention Studies, African Americans, Family, Body mass index
Analysis Of Equilibrium And Motor Coordination Of Deaf Children's Pre And Post Intervention Physiotherapeutic

Study Overview
=================
Brief Summary
-----------------
This study aimed to assess and reassess the balance and motor skills of deaf children, passed six weeks of intervention and to verify whether a program of physical therapy intervention can match or improve motor skills. This study was quasi-experimental before and after, with 10 children from a school in Caxias do Sul / RS. Motor skills were evaluated using pre and post test KTK Coordination Body, and the activities were held once a week for six weeks in sessions of forty minutes. It was used for statistical analysis the Student t test dependent and independent (p ≤ 0.05).

Official Title
-----------------
Analysis Of Equilibrium And Motor Coordination Of Deaf Children's Pre And Post Intervention Physiotherapeutic

Conditions
-----------------
Motor Skills in Deaf Children, Deafness

Intervention / Treatment
-----------------
* Other: physiotherapy intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 7 to 10 years of age. hearing disorders proven by presenting specific examination of Auditory Evoked Potential and Examination of the brainstem (Brainstem Evoked Response - Bera). consent of parents / guardians of children to participate in the study by signing Term of Informed Consent (IC). Exclusion Criteria:

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 10 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: deaf children<br> | Other: physiotherapy intervention<br>* a program of physical therapy intervention can match or improve motor skills in the deaf children<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Balance |  | two months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| motor coordination |  | two months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Physiotherapy., Deafness., Postural balance., Motor skills.
The Effects of PXR Activation on Hepatic Fat Content

Study Overview
=================
Brief Summary
-----------------
This study investigates the effects of pregnane X receptor (PXR) activation on hepatic fat content in healthy volunteers. Rifampicin (an antibiotic and also an efficient PXR activator) and placebo will be given for a week to volunteers. Hepatic fat content is measured with magnetic resonance imaging and blood samples are collected at the end of each study arm. The investigators' hypothesis is that rifampicin causes accumulation of fat to the liver.

Official Title
-----------------
PXR-aktivaation Vaikutus Maksan Rasvoittumiseen

Conditions
-----------------
Non-alcoholic Fatty Liver Disease

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers Body mass index (BMI) 18.5-25 kg/m2 Exclusion Criteria: Systolic blood pressure over 150 mmHg Any continuous medication (hormonal intrauterine device is permitted) Any significant medical condition Insensitivity to rifampicin Pregnancy and lactation Previous difficult venipuncture Alcohol and medicine abuse and drug use Participation to any other pharmaceutical trial within on month of screening Claustrophobia Metal and other implants which are contraindications to MRI

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

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rifampicin<br>Rifampicin 600 mg tablet once a day orally for a week. | Drug: Rifampicin<br> <br> * Other names: Rifampin;|
| Placebo Comparator: Placebo<br>Placebo tablet once a day orally for a week. | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hepatic fat fraction |  | Day 8 |
Intravenous Versus Intra-peritoneal Dexamethasone on the Incidence of Postoperative Nausea and Vomiting

Study Overview
=================
Brief Summary
-----------------
Effect of intravenous versus intra-peritoneal dexamethasone on the incidence of postoperative nausea and vomiting following Laparoscopic gynecological surgeries.

Official Title
-----------------
Effect of Intravenous Versus Intra-peritoneal Dexamethasone on the Incidence of Postoperative Nausea and Vomiting Following Laparoscopic Gynecological Surgeries

Conditions
-----------------
Postoperative Nausea and Vomiting

Intervention / Treatment
-----------------
* Drug: Intravenous Dexamethasone
* Drug: Intraperitoneal Dexamesathone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult Female patients American society of anesthesiologist class I & II Undergoing Laparoscopic gynecological surgeries Exclusion Criteria: Patient refusal to participate in the study Patients with coagulopathy or under anticoagulation therapy. Infection near the site of needle insertion. Body mass index > 40kg/m2 Patients with any neurological or neuromuscular disorder or history of seizures. Known allergy to any drug used in the study.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intravenous dexamethasone<br>50 patients will receive intravenous dexamethasone | Drug: Intravenous Dexamethasone<br> <br> |
| Active Comparator: Intra peritoneal dexamethasone<br>50 patients will receive intraperitoneal dexamethasone | Drug: Intraperitoneal Dexamesathone<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative nausea and vomiting (PONV) | PONV will be measured by using Verbal Descriptive Scale | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Pain will be assessed by using visual analogue scale | 24 hours |