linjc16/ctgov huggingface dataset:
Feasibility Study: The Effect of Prazosin for Nighttime Symptoms of Civilian PTSD

Study Overview
=================
Brief Summary
-----------------
Investigating the effect of prazosin for nighttime symptoms of civilian Posttraumatic Stress Disorder.

Detailed Description
-----------------
Each subject will receive prazosin and placebo trials, the order randomized. Day and nighttime symptoms will be monitored.

Official Title
-----------------
The Effect of Prazosin for Nighttime Symptoms of Civilian PTSD

Conditions
-----------------
Stress Disorders, Post-Traumatic

Intervention / Treatment
-----------------
* Drug: prazosin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: must meet DSM-IV criterion for PTSD Exclusion Criteria: Must not have untreated sleep apnea

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: prazosin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep time |  |  | 
| REM sleep time |  |  | 
| Nightmare frequency |  |  | 
| CGI |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distressed Awakenings frequency |  |  | 
| PCL-C |  |  |
Review of Post-Study Clinical Endoscopy Reports in Follow Up to MAY2016-07-01

Study Overview
=================
Brief Summary
-----------------
This study reviews post study clinical endoscopy reports in follow up to patients who participated in MAY2016-07-01 with weekly erlotinib for familial adenomatous polyposis. Reviewing follow up medical records may help researchers examine the extent of rapid progression of familiar adenomatous polyposis disease burden after discontinuation of weekly erlotinib.

Detailed Description
-----------------
PRIMARY OBJECTIVE: I. To review clinical endoscopy reports, pathology reports, and other medical records related to standard-of-care endoscopic evaluations for all participants in the parent study, MAY2016-07-01, to determine the extent of reports of rapid progression of recurrent polyps after completion intervention and follow up under the parent protocol. OUTLINE: Patients who participated in MAY2016-07-01 undergo review of medical records.

Official Title
-----------------
Review of Post-Study Clinical Endoscopy Reports in Follow Up to MAY2016-07-01 Weekly Erlotinib for Familial Adenomatous Polyposis

Conditions
-----------------
Familial Adenomatous Polyposis

Intervention / Treatment
-----------------
* Other: Electronic Health Record Review


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: MAY2016-07-01 study participants for whom medical records are available and accessible Exclusion Criteria: MAY2016-07-01 study participants who have opted out of medical records reviews or for whom consent for medical record review cannot be confirmed/documented
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational (medical record review)<br>Patients who participated in MAY2016-07-01 undergo review of medical records. | Other: Electronic Health Record Review<br>* Review of medical records<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of study participants exhibiting clinically significant progression of duodenal neoplasia after completion of study drug | Will be assessed by endoscopy. | At completion of study | 
| Number of participants who underwent surgical resection | Will determine the number of participants who underwent surgical resection for management of advanced upper gastrointestinal (GI) neoplasia/cancer between the date of completion of intervention and 2/28/2021. | At completion of study | 
| Number of participants who required endoscopic resection of advanced upper gastrointestinal (GI) neoplasms |  | At completion of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with evidence of progression of upper GI disease | Will be calculated by increase in Spigelman stage. | At completion of study |
Symptom Management for Irritable Bowel Syndrome

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to test the efficacy of a symptom management treatment strategy, Acupuncture/Moxibustion (Acu/Moxa), to improve the symptoms associated with Irritable Bowel Syndrome (IBS) in adults.

Official Title
-----------------
Symptom Management for Irritable Bowel Syndrome

Conditions
-----------------
Irritable Bowel Syndrome

Intervention / Treatment
-----------------
* Other: Standard protocol
* Other: Individualized protocol
* Other: Sham acupuncture/Placebo moxa


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women 18 to 70 years of age. Diagnosis of IBS based on ROME III criteria. Complete symptom diaries and return completed diaries at all sessions. Exclusion Criteria: History of co-existing gastrointestinal, and/or gynecological, and/or urologic pathology. Alarm symptoms according to ROME III. Individuals currently receiving other types of complementary therapies. Individuals with an acute medical condition requiring acute medical attention.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard<br>Fixed protocol | Other: Standard protocol<br>* Subjects will receive a standard treatment<br>|
| Experimental: Individualized<br>Individualized protocol | Other: Individualized protocol<br>* Subjects will receive an individualized treatment<br>|
| Sham Comparator: Control<br>Sham acupuncture/Placebo moxa | Other: Sham acupuncture/Placebo moxa<br>* Subjects will receive sham acupuncture/placebo moxa<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom severity-abdominal pain |  | week 1 | 
| Symptom severity-abdominal pain |  | week 4 | 
| Symptom severity-abdominal pain |  | week 8 | 
| Symptom severity-abdominal pain |  | week 12 | 
| Symptom severity-abdominal pain |  | week 24 |
Psychometric Properties of the Turkish Version of Young Children's Participation and Environment Measure

Study Overview
=================
Brief Summary
-----------------
The Young Children's Participation and Environment Measure (YC-PEM) is a parent/caregiver reported outcome measure that evaluates the participation status and environmental factors of children under five years old. The aim of this study is to translate the Young Children's Participation and Environment Measure (YC-PEM) into the Turkish language and to investigate the psychometric properties of the Turkish version of YC-PEM in children with typical development and neurodevelopmental disabilities under five years old.

Detailed Description
-----------------
Cross-cultural adaptation Rest-retest reliability Discriminant validity Concurrent validity

Official Title
-----------------
Psychometric Properties of the Turkish Version of Young Children's Participation and Environment Measure (YC-PEM) in Young Children With Typical Development and Neurodevelopmental Disorders

Conditions
-----------------
Child Development Disorder, Activity, Motor

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children under five years children with neurodevelopmental disabilities Exclusion Criteria: parents who refused to participate in the study

Ages Eligible for Study
-----------------
Minimum Age: 12 Months
Maximum Age: 60 Months

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 |
| --- | --- |
| Group 1<br>Children under five years old | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Young children's participation and environment measure (YC- PEM) | Young children's participation and environment measure (YC- PEM) is developed for assessing the activity and participation levels and effects of environmental factors on functional abilities in children with neurodevelopmental disabilities or typically development under five years. | two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pediatric Evaluation of Disability Inventory (PEDI) | Pediatric Evaluation of Disability Inventory (PEDI) for assessing the activity and participation levels and effects of environmental factors on functional abilities in children with neurodevelopmental disabilities or typically development under seven years. | two years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cerebral palsy, Activity, Participaiton, Environment
A Gene Hunting Study for Familial Papillary Thyroid Cancer

Study Overview
=================
Brief Summary
-----------------
The aim of this project is to identify genetic risk factors associated with familial papillary thyroid carcinoma (PTC). Papillary thyroid cancer is a type of cancer that shows high heritability. However, the specific genetic factors that cause an increased risk have been elusive.

Detailed Description
-----------------
The aim of this project is to identify genetic risk factors associated with familial papillary thyroid carcinoma (PTC). This can be accomplished in several ways, including loss of heterozygosity studies as well as comparative gene expression analysis. When possible, linkage analysis on families with multiple individuals affected with PTC may also help identify the putative gene(s). Study participants will be asked to: Complete family history and medical history questionnaires Sign a medical record release so that thyroid cancer pathology reports can be obtained Supply a blood or saliva sample for genetic studies Provide study related information to family members who are needed for family studies

Official Title
-----------------
A Strategy to Search for Genes Predisposing to Papillary Carcinoma of the Thyroid When Mutated

Conditions
-----------------
Thyroid

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a diagnosis of PTC and a family history of PTC in 3 or more living relatives Affected and unaffected family members of the proband* For familial cases (families with 4 or more cases of PTC), participation will be offered to all living family members with PTC or benign thyroid disease as well as selected unaffected first and second degree relatives. Participation may also be offered to spouses when needed for analyzing parent/offspring samples. Exclusion Criteria: Known germline predisposition (ex: pathogenic PTEN variant) Non-English speaking

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 |
| --- | --- | --- |
| Genetic variants associated with familial papillary thyroid cancer as assessed by multiple genetic testing methodologies | Variants will be assessed for segregation within families, expression in the normal thyroid and/or thyroid cancer, and functional significance | Up to 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Papillary Carcinoma, Gene Hunting, Familial
Colloid Osmotic Pressure and Osmolality in Hyponatremia

Study Overview
=================
Brief Summary
-----------------
Hyponatremia (serum sodium of less than 135 mmol/L)is a very common electrolyte disorder. The reasons for the disorder varies as well as if it is acute or chronic. In this study we wish to follow changes in colloid osmotic pressure and osmolality during the initial treatment hours. We also wish to use mass balance for the calculation of body compartments and to detect fluid translocation between these.

Detailed Description
-----------------
Patients with hyponatremia arriving att the intensive care unit are asked to participate in the study. The first blood samples are collected before initializing the treatment as well as measurements of body compartments with a bioimpedance analyzer. Collected blood samples are electrolytes (Sodium, Potassium and Chloride), colloid osmotic pressure, osmolality and hemoglobin. These samples are repeated at 4 and 8 hours after start of the study. Amount of infused fluid as well as electrolytes are recorded. Urine volume is measured and urine samples are analyzed for the loss of electrolytes. Additional samples for guidance of treatment are collected every hour. Hopefully the addition of colloid osmotic pressure, osmolality and mass balance can be beneficial in the diagnosis of the reason for the disorder as well as for the treatment.

Official Title
-----------------
Colloid Osmotic Pressure and Osmolality in Hyponatremia. Additional Diagnostic Aspects and Guide to Treatment

Conditions
-----------------
Hyponatremia

Intervention / Treatment
-----------------
* Drug: Sodium chloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients treated for Hyponatremia at the intensive care unit. Exclusion Criteria: Circulatory instable patients in need of treatment for more than the hyponatremia.

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 |
| --- | --- |
| Hyponatremia<br>Patients treated for hyponatremia (<125 mmol/L Sodium) in the intensive care department. | Drug: Sodium chloride<br>* Treatment with Sodium chloride<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Colloid osmotic pressure | Measurement of colloid osmotic pressure | 8 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body compartments | Bioimpedance analysis is performed every 4 hours. | 8 hours. | 
| Body compartments | Mass balance Sodium and Chloride | 8 hours |
The Use of B-type Natriuretic Peptide (BNP) to Predict Closure of a Patent Ductus Arteriosus (PDA) in Premature Infants

Study Overview
=================
Brief Summary
-----------------
A patent ductus arteriosus (PDA) is associated with increased morbidity in premature infants. Standard indomethacin treatment is associated with intestinal and renal morbidity. B-type natriuretic peptide is elevated in significant PDAs. This study will determine whether BNP guided therapy could reduce doses of indomethacin.

Conditions
-----------------
Indomethacin Therapy, Patent Ductus Arteriosus

Intervention / Treatment
-----------------
* Procedure: Withhold standard INDO dose if BNP < 100 pg/ml


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants with echocardiographically confirmed PDA Infants determined by attending physician to require PDA closure Exclusion Criteria: infants with congenital hearts disease infants with creatinine value > 2.0

Ages Eligible for Study
-----------------
Maximum Age: 4 Months

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Withhold standard INDO dose if BNP < 100 pg/ml|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of indomethacin doses given on study |  | 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of PDA ligation |  | Discharge from NICU | 
| Rate of Chronic lung disease |  | 36 weeks corrected gestational age | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
indomethacin therapy, patent ductus arteriosus
Treatment of Elderly Patients (>65 Years) With Acute Lymphoblastic Leukemia

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to test feasibility and efficacy of a dose reduced chemotherapy in elderly patients with newly diagnosed acute lymphoblastic leukemia. The regimen consists of induction phase I and II followed by cyclic consolidation cycles, reinduction and maintenance therapy

Official Title
-----------------
Pilot Study for Treatment of Elderly Patients (>65 Years) With Acute Lymphoblastic Leukemia

Conditions
-----------------
Adult Acute Lymphocytic Leukemia

Intervention / Treatment
-----------------
* Drug: Adriamycin
* Drug: Cyclophosphamide
* Drug: Cytarabine
* Drug: Dexamethasone
* Drug: Idarubicin
* Drug: Ifosfamide
* Drug: Methotrexate
* Drug: Mercaptopurine
* Drug: VM26
* Drug: Vincristine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of acute lymphoblastic leukemia (pro-B,common,pre-B,pre-T,Thy-,mature T, B-ALL) age > 65 years written informed consent Karnofsky > 50% (if not mainly caused by leukemia) laboratory at diagnosis or after supportive pre-treatment Creatinine < 2 mg/dl Uric Acid < 8 mg/dl Bilirubin < 1.5 mg/dl ALA, ASA,AP < 2.5 x ULN Exclusion Criteria: severe second diseases (e.g. renal failure, cardiomyopathy etc., not caused by leukemia) that exclude treatment according to the protocol severe psychiatric illness or other circumstances which may compromise cooperation active second neoplasia clinical signs of life threatening infections or bleeding, uncontrollable prior to chemotherapy

Ages Eligible for Study
-----------------
Minimum Age: 65 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: Adriamycin|nan|
|Drug: Cyclophosphamide|nan|
|Drug: Cytarabine|nan|
|Drug: Dexamethasone|nan|
|Drug: Idarubicin|nan|
|Drug: Ifosfamide|nan|
|Drug: Methotrexate|nan|
|Drug: Mercaptopurine|nan|
|Drug: VM26|nan|
|Drug: Vincristine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Results of induction therapy,Distribution of entry criteria,Treatment feasibility,Relapse rate and localisation,Death in CR,Remission duration, survival and leukemia free survival,Prognostic factors,Quality of life |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ALL, Elderly, Chemotherapy
Continuous Positive Airway Pressure in Sleep Apnea Syndrome: Effects on Metabolic Syndrome and Cardiac Damage

Study Overview
=================
Brief Summary
-----------------
To assess in moderate to severe Obstructive Sleep Apnea the effects of one year therapy with nighttime continuous positive airway pressure ventilation on the prevalence of metabolic syndrome and cardiovascular damage.

Official Title
-----------------
Effects of the Continuous Positive Airway Pressure Ventilation on the Prevalence of the Metabolic Syndrome and Cardiac Morpho-Functional Characteristics in Sleep Apnea Syndrome

Conditions
-----------------
Sleep Apnea Syndrome, Metabolic Syndrome, Cardiac Remodelling, Continuous Positive Airway Pressure Ventilation

Intervention / Treatment
-----------------
* Device: continuous positive airway pressure ventilation
* Behavioral: dietary and life style recommendations
* Behavioral: dietary and life style recommendations


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: moderate to severe sleep apnea syndrome Exclusion Criteria: cardiovascular diseases (coronary artery disease, stroke, peripheral artery disease) thyroid diseases diabetes

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>continuous positive airway pressure ventilation + dietary and life style recommendations | Device: continuous positive airway pressure ventilation<br>* nighttime<br>Behavioral: dietary and life style recommendations<br> <br> |
| Active Comparator: 2<br>dietary and life style recommendations | Behavioral: dietary and life style recommendations<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| metabolic syndrome |  | one year | 
| left ventricular mass |  | one year | 
| diastolic function |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sleep apnea syndrome, metabolic syndrome, cardiac remodelling, continuous positive airway pressure ventilation