linjc16/ctgov huggingface dataset:
Long-term Study in Chronic Kidney Disease Patients With Hyperphosphatemia Not on Dialysis

Study Overview
=================
Brief Summary
-----------------
This is a multi-center, open-labeled, non-comparative study to examine the safety and efficacy of ASP1585 for long-term dosing in chronic kidney disease patients with hyperphosphatemia not on dialysis.

Official Title
-----------------
ASP1585 Phase 3 Long-term Study in Chronic Kidney Disease Patients With Hyperphosphatemia Not on Dialysis

Conditions
-----------------
Chronic Kidney Disease, Renal Insufficiency, Hyperphosphatemia

Intervention / Treatment
-----------------
* Drug: ASP1585


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who completed study 1585-CL-0101 or new patients who meet following criteria Chronic kidney disease patients (eGFR < 60 mL/min/1.73 m2) Serum phosphorus measurement ≧4.6 mg/dl, <9.0 mg/dl Written informed consent Exclusion Criteria: Patients with gastrointestinal surgery or enterectomy Patients with severe cardiac diseases Patients with severe constipation or diarrhea Patients with a history or complication of malignant tumors Patients with uncontrolled hypertension Patients treated with parathyroid intervention

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| Experimental: ASP1585 group<br> | Drug: ASP1585<br>* oral<br>* Other names: bixalomer;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time-course changes in serum phosphorus levels |  | During 48 week treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achievement rate of the target range of serum phosphorus level |  | During 48 week treatment | 
| Time to achieve the target range of serum phosphorus level |  | During 48 week treatment | 
| Time-course changes in serum calcium levels |  | During 48 week treatment | 
| Time-course changes in serum intact PTH (parathyroid hormone) levels |  | During 48 week treatment | 
| Safety assessed by the incidence of adverse events, vital signs, labo-tests and 12-lead ECGs |  | During 48 week treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CKD, Not on dialysis, ASP1585, Bixalomer
Pre-Hospital Cerebral Oxygenation and End-Tidal CO2 During Cardiopulmonary Resuscitation (CPR)

Study Overview
=================
Brief Summary
-----------------
Cerebral saturation will be measured pre-hospital during an out-of hospital cardiac arrest with O3TM regional oximetry for Root® (Masimo®). The O3TM regional oximetry for Root® (Masimo®) is a device that can measure not only cerebral saturation but also end-tidal CO2 (capnography). Currently, end-tidal CO2 is already measured during Advanced Life Support following most recent European Resuscitation Guidelines but with another monitor. Until now it is the only parameter which may predict return of spontaneous circulation. Because of this, researchers want to measure both with the same device, which gives the investigators the opportunity and advantage to compare end-tidal CO2 and cerebral saturation very precisely. In this manner researchers want to investigate the predictive value of cerebral saturation and compare it end-tidal CO2.

Official Title
-----------------
Pre-Hospital Cerebral Oxygenation and End-Tidal CO2 During Cardiopulmonary Resuscitation (CPR)

Conditions
-----------------
out-of Hospital Cardiac Arrest

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all consecutive OHCA patients Exclusion Criteria: DNR code no possibility to attach cerebral oxygenation sensor

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- | --- |
| Clinical parameter: return of spontaneous circulation (ROSC) by pulse check | Difference between regional cerebral saturation and end-tidal carbon dioxide in detecting return of spontaneous circulation | when ROSC occurs, within 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cerebral saturation, capnography, pre-hospital
Effect of Early Systemic Stabilization Therapy on Recent Onset Vitiligo

Study Overview
=================
Brief Summary
-----------------
Vitiligo is a distressing disorder of depigmentation. In spite of multiple successful therapeutic regimens, disease relapse remains a challenge to patients and physicians. Most guidelines consider systemic treatments only in rapidly progressive disease with wider surface areas. This delay in halting the immune attack, may give the chance for further disease progression as well as establishment of resident memory T cell population predisposing to future disease relapses. The aim of this study was to assess the ability of early systemic therapy of localized (<2% BSA), recent onset (<6 months) vitiligo to control disease activity and minimize the possibility of recurrence.

Official Title
-----------------
Evaluation of Early Systemic Stabilization Therapy on Recent Onset Localized Non-segmental Vitiligo

Conditions
-----------------
Vitiligo

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients ≥ 6 years old of both genders Early onset vitiligo (˂6m duration) Body surface area (BSA) affected ≤2% Exclusion Criteria: Patients who received any previous treatment for vitiligo Pregnant and lactating females Patients with other cutaneous or systemic autoimmune diseases Patients with contraindication to systemic corticosteroids

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 60 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 |
| --- | --- | --- |
| Duration needed to arrest of vitiligo activity | Time needed for vitiligo patients to stop developing new lesions of vitiligo | 6 months | 
| Duration of maintaining vitiligo stability | Time before any new vitiligo lesions reappear | 5 years |
Randomized Trial of Prolonged Exposure for the Treatment of Posttraumatic Stress Disorder (PTSD)

Study Overview
=================
Brief Summary
-----------------
This project will examine the impact of PE therapy for the treatment of PTSD with a sample of Latinos. The need to provide effective treatment to Spanish-speaking Latinos with PTSD is critical given the high prevalence of PTSD among Latinos. Furthermore, PTSD remains an under detected and under treated condition. Untreated PTSD has a substantial impact on health, functioning and quality of life. PE is one of the most empirically supported psychological interventions for PTSD. However, most studies that evidence the efficacy of PE have been conducted mainly with English-speaking Caucasian populations. This study has the potential to contribute to improvements in the well-being of Spanish-speaking Latinos with PTSD.

Conditions
-----------------
Posttraumatic Stress Disorder

Intervention / Treatment
-----------------
* Behavioral: Prolonged Exposure
* Behavioral: Applied Relaxation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 to < 65 years Meet diagnostic criteria for PTSD Spanish speaker Allow recording of assessments and therapy Exclusion Criteria: Significant current suicidal or homicidal ideation History of bipolar, schizophrenia or psychotic disorder Alcohol or drug abuse during the past three months Current high risk of being assaulted (i.e., living with domestic violence) Current psychotherapy to treat PTSD Unable to provide informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prolonged Exposure<br>Behavioral: Prolonged Exposure (PE) PE is a 16 week, 90 minute culturally informed treatment program. | Behavioral: Prolonged Exposure<br> <br> |
| Active Comparator: Applied Relaxation<br>Behavioral: Applied Relaxation (AR) AR is a 16 week, 90 minute treatment program. | Behavioral: Applied Relaxation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Clinician Administered PTSD Scales (CAPS) |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in SF-12 |  | 6 months | 
| Change in Sheehan Disability Scale |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Posttraumatic Stress Disorder (PTSD), Prolonged Exposure (PE)
6 Minute Push & 30 Second Sprint Tests Reliability & Relationship to Fitness, Participation, & Environmental Assessments

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the relationship between physical fitness and wheelchair mobility capacity and 1) participation; 2) self-reported environments barriers; and 3) self-reported avoidance of environmental features.

Official Title
-----------------
6 Minute Push and 30 Second Sprint Tests Reliability and Relationship to Fitness, Participation, and Environmental Assessments

Conditions
-----------------
Spinal Cord Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: at least 1 year post-injury able to self-propel a manual wheelchair spinal cord injury between C5 and T5 Exclusion Criteria: spinal cord injury above C5 or below T5 spinal cord injury severity of AIS D unstable angina or myocardial infarction within the past month resting heart rate >120 systolic blood pressure >180 mm Hg, or diastolic blood pressure >100 mm HG

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 Minute Push Test |  | Visit 3 and 4 | 
| 30 Second Sprint Test |  | Visit 3 and 4 |
Lifemel Honey to Reduce Leucopenia During Chemotherapy

Study Overview
=================
Brief Summary
-----------------
This study will include 60 patients with early breast cancer referred to receive adjuvant chemotherapy with AC ( adriamycin- cyclophosphamide) or CAF ( adriamycin- cyclophosphamide- 5- fluorouracil ) combinations. These patients will receive every day one spoon of Lifemel honey or regular honey ( double blind)- during the adjuvant chemotherapy .Every week a WBC count will be performed in order to record the influence of Lifemel on myelotoxicity.

Official Title
-----------------
Lifemel Honey During Adjuvant Chemotherapy for Breast Cancer Patients to Prevent Leucopenia

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

Intervention / Treatment
-----------------
* Behavioral: Lifemel honey intake every day


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: breast cancer patient treated with adjuvant chemotherapy PS = 2 or less Exclusion Criteria: none

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Lifemel honey intake every day|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevention of myelotoxicity-every week during chemotherapy. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast cancer, honey, myelosuppression, chemotherapy
Renal Osteodystrophy: A Fresh Approach

Study Overview
=================
Brief Summary
-----------------
There are two major goals of this project: Comparison of DXA and QCT for diagnosis of bone loss in CKD-5 patients and determination of the prevalence of low bone turnover in CKD-5 patients with bone loss. Identification of the optimal combination of noninvasive tests for definition of the turnover component of ROD.

Official Title
-----------------
Renal Osteodystrophy: A Fresh Approach

Conditions
-----------------
Renal Osteodystrophy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 18 years or older; Chronic maintenance dialysis of at least 3 months' duration; Mental competence; Willingness to participate in the study; Calcidiol levels within normal range. Exclusion Criteria: Pregnancy; Systemic illnesses or organ diseases that may affect bone (except type 1 or type 2 diabetes mellitus); Clinical condition that may limit study participation (e.g., unstable angina, respiratory distress, infections). Chronic alcoholism and/or drug addiction; Participation in a study of an investigational drug during the past 90 days; Allergy to tetracycline. Planning to move out of the area within 2 years of the study; On active transplant list; Treatment within last 6 months with drugs that may affect bone metabolism (except for treatment with calcitriol, vitamin D analogs and/or calcimimetics). Calcidiol level below the normal range. The current routine clinical practice in our dialysis clinics is to check calcidiol status twice yearly and supplement with vitamin D according to serum calcidiol levels. It is therefore unlikely that a substantial number of patients will be excluded due to this exclusion criterion.

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 |
| --- | --- | --- |
| Comparison of DXA and QCT for diagnosis of bone loss in CKD-5 patients and determination of the prevalence of low bone turnover in CKD-5 patients with bone loss. | Because each method (QCT or DXA) yields a dichotomous response (bone loss: yes or no), the proportion of patients with a bone loss will be compared between the 2 methods by using the McNemar statistic for correlated proportions. | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of the optimal combination of noninvasive tests for definition of the turnover component of ROD. | A stepwise logistic model will be used to determine which combination of PTH and bone markers best predicts low bone turnover. | 4 years |
Quality of Life of Patients With a History of Drug Allergy in Thailand

Study Overview
=================
Brief Summary
-----------------
Quality of life of patients with a history of drug allergy in Thailand will be studied.

Detailed Description
-----------------
Thai patients with a history of drug allergy will be evaluated for their quality of life based on drug hypersensitivity quality of life questionnaire (DrHy-Q; Thai version) and The World Health Organization Quality of Life instrument (WHOQOL-BREF-THAI)

Official Title
-----------------
Quality of Life of Patients With a History of Drug Allergy in Thailand

Conditions
-----------------
Quality of Life

Intervention / Treatment
-----------------
* Other: Questionnaires


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have a history of drug allergy At least 18 years of age Exclusion Criteria: Not be able to understand Thai language

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 |
| --- | --- |
| Drug allergy patients<br>Patients with a history of drug allergy in Thailand | Other: Questionnaires<br>* DrHy-Q (Thai version) and WHOQOL-BREF-THAI will be asked<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The quality of life of Thai patients with a history of drug allergy evaluating by DrHy-Q (Thai version) |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The correlation between DrHy-Q (Thai version) and WHOQOL-BREF-THAI | Pearson correlation coefficient between scores from DrHy-Q (Thai version) and WHOQOL-BREF-THAI in patients with a history of drug allergy will be analyzed. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Quality of life
Novel Surgical Checklists for Gynecologic Laparoscopy in Haiti

Study Overview
=================
Brief Summary
-----------------
The researchers traveled to University Hospital Mirebalais in Haiti and provided a one week long laparoscopic training and simulation course to the 7 OBGYN faculty there. The researchers used novel checklists to help the faculty to set up for laparoscopic cases and care for the equipment needed. The researchers then asked the physicians their opinion of the checklists.

Official Title
-----------------
Use of Novel Surgical Checklists for Gynecologic Laparoscopy in Haiti: Utility in Bending the Learning Curve for Global Programs

Conditions
-----------------
Gynecology, Surgery

Intervention / Treatment
-----------------
* Procedure: Surgical training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: OBGYN physician in Haiti Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Physicians in Haiti<br>7 OBGYN physicians underwent a laparoscopic training and simulation course and then were proctored as they performed 3 in vivo cases using a check list to help the participants remember all the steps of laparoscopic set-up. | Procedure: Surgical training<br>* This was a gyn laparoscopy training and simulation course<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of physicians that reported favoring the checklist greater than 3 on a likert scale of 1-5. | Likert scale 1-5. 5 indicates highest satisfaction with the checklist. | 1 week |
Preoperative Combined Radiation and Chemotherapy - Rectal Cancer

Study Overview
=================
Brief Summary
-----------------
There is no established standard preoperative treatment in rectal cancer. Two large randomized studies in North America closed from lack of accrual; therefore the only method of assessing preoperative treatment in rectal cancer is from Phase II studies. This study builds on the experience at PMH gained in two previous studies which demonstrated a lower than expected toxicity with concurrent 5FU infusion and external radiotherapy. The current standard at PMH is preoperative radiation, 46Gy in 23 fractions with concurrent 5FU infusion 225mg/m2. An increase of radiation dose and consequent increase in chemotherapy may improve the response rate, but may also increase toxicity. It is proposed to increase the dose of radiotherapy to 50Gy in 25 fractions with concurrent chemotherapy and measure acute toxicity and complete remission rate.

Official Title
-----------------
A Phase II Protocol of Preoperative Combined Radiation and Chemotherapy for Resectable Primary Rectal Cancer

Conditions
-----------------
Rectal Neoplasms

Intervention / Treatment
-----------------
* Procedure: Combined Radiation and Chemotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Biopsy proven adenocarcinoma of the rectum Performance status <2 (ECOG, appendix II) Clinical Stage T2 N1-2, T3-4 NO-2, without evidence of distant metastasis Exclusion Criteria: Prior pelvic irradiation Inflammatory bowel disease Evidence of distant metastasis Performance status >2

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 |
| --- |
|Procedure: Combined Radiation and Chemotherapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess acute toxicity and complete remission rate of combined preoperative radiation and chemotherapy |  |  |