linjc16/ctgov huggingface dataset:
Use of Guided Imagery for Functional Abdominal Pain in Children:

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the effectiveness of relaxation, with or without guided imagery, for treating children with functional abdominal pain. The study will evaluate a child's ability to decrease the amount of pain with these techniques to allow continuation of normal daily activities at home and at school. The hypothesis is that these relaxation techniques will help decrease reports of abdominal pain and improve levels of activity.

Official Title
-----------------
Treatment of Functional Abdominal Pain in Children:Evaluation of Relaxation/Guided Imagery and Chamomile Tea as Therapeutic Modalities

Conditions
-----------------
Functional Abdominal Pain

Intervention / Treatment
-----------------
* Behavioral: guided imagery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: at least 3 episodes of abdominal pain over the previous 3 months normal complete blood count, sedimentation rate, urinalysis stable on current medications English speaking - Exclusion Criteria: unwillingness to participate chronic gastrointestinal disease cognitive-developmental delay major dissociative disorder -

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 18 Years

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: guided imagery|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of pain |  |  | 
| number of days of pain |  |  | 
| missed activities |  |  |
Weekly Docetaxel Plus Cisplatin as the First-line Therapy for Nasopharyngeal Cancer

Study Overview
=================
Brief Summary
-----------------
The investigators will evaluate weekly docetaxel plus 3-weekly cisplatin regimen as the first-line therapy for recurrent of metastatic nasophayngeal cancer

Official Title
-----------------
Phase II Trial of Cisplatin Plus Weekly Docetaxel as the First-line Treatment for Recurrent or Metastatic Nasopharyngeal Cancer

Conditions
-----------------
Nasopharyngeal Cancer

Intervention / Treatment
-----------------
* Drug: Docetaxel, Cisplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histologically confirmed nasopharyngeal cancer chemotherapy or radiotherapy naive (but, including patients completed 6 months before the enrollment) ECOG 0-1 at least one measurable lesion Exclusion Criteria: other cancer pregnat docetaxel hypersentitivity history severe heart or pulmonary disease

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 |
| --- | --- |
| Experimental: weekly docetaxel and cisplatin<br>Docetaxel 35mg/m2 D1 & D8 Cisplatin 70mg/m2 D1 every 3 weeks maxinum 6 cycles | Drug: Docetaxel, Cisplatin<br>* Docetaxel 35mg/m2 D1 & D8 Cisplatin 70mg/m2 D1<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| objective response rate |  | 6 months after the enrollment of the last patients | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients with adverse events |  | simultaneously when the analysis of primary endpoint | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nasopharyngeal cancer, weekly docetaxel, cisplatin
Risk Stratification of Post Tonsillectomy Respiratory Complications in the Pediatric Population

Study Overview
=================
Brief Summary
-----------------
Obstructive sleep apnea syndrome (OSAS) is the most common indication for tonsillectomy and adenoidectomy in young children. According to previous studies, as much as 8 to 20% of patients will develop post operative respiratory complications requiring medical intervention. The pre-operative risk factors that could predict respiratory complications retrospectively analyzed were young age, obesity and high preoperative apnea-hypopnea index. Despite the removal of obstructing lymphoid tissue, upper airway obstruction occurs on the first postoperative night in children with OSA. There is a debate regarding the post-operative duration and monitoring needed in children with OSA. Hypothesis: Pre-operative, operative and immediate post-operative parameters could predict post tonsillectomy respiratory complications.

Conditions
-----------------
Post Tonsillectomy Respiratory Complications

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pediatric patient < 14 years old Obstructive sleep apnea according to polysomnography Surgery: Tonsillectomy/Tonsillotomy Exclusion Criteria: 1. Patient suffering from known respiratory disease

Ages Eligible for Study
-----------------
Maximum Age: 14 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| post tonsillectomy<br>children | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| respiratory distress |  |  |
Treatment of Japanese Encephalitis

Study Overview
=================
Brief Summary
-----------------
Japanese encephalitis is the single largest cause of viral encephalitis in the world today. It occurs in yearly post monsoon outbreaks in Uttar Pradesh and other parts of India and south east Asia. There is presently no antiviral drug of proven benefit for this illness and treatment is mostly supportive. The drug Ribavirin is already in the market in use for other indications. It has been found useful in West Nile encephalitis and various hemorrhagic fevers caused by related arboviruses. This is a double blind placebo of Ribavirin in Japanese encephalitis. To the best of our knowledge, this is the first such trial in the world. The study hypothesis is that children treated with ribavirin will be no different from those getting placebo in terms of mortality, length of hospital stay, days to return to consciousness and oral feeds, days to become afebrile and convulsion free and in 3 month sequelae rate.

Official Title
-----------------
Treatment of Japanese Encephalitis - a Double Blind Placebo Controlled Trial

Conditions
-----------------
Japanese Encephalitis

Intervention / Treatment
-----------------
* Drug: Ribavirin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Child between 6 months and 12 years age Acute febrile encephalopathy Positive IgM ELISA test for Japanese encephalitis in serum Exclusion Criteria: Consent not obtained

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 12 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: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality during hospital stay |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sequelae at 3 months |  |  | 
| Duration of hospital stay |  |  | 
| Days to return to oral feeds |  |  | 
| Days to become convulsion free |  |  | 
| Days to become afebrile |  |  |
Casodex vs Placebo in Non-Metastatic Early Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to study the effect of adjuvant or immediate hormonal therapy, versus placebo, in subjects who have either undergone a primary therapy (principally radical prostatectomy or radiotherapy) or who were otherwise to be managed by watchful waiting.

Official Title
-----------------
A Randomized, Double-Blind, Parallel-Group Trial Comparing Casodex 150mg Once Daily With Placebo in Patients With Non-Metastatic Prostate Cancer.

Conditions
-----------------
Non-Metastatic Prostate Cancer

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of non-metastatic cancer of the prostate gland Patient to be 18 years and above Exclusion Criteria: Previous systemic therapy for prostate cancer Previous history of another form of cancer (not prostate) within 5 years of study start.

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

Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- |
| Placebo Comparator: A<br> | Drug: Placebo<br> <br> |
| Active Comparator: B<br> | Drug: Bicalutamide<br>* 150mg p.o. daily<br>* Other names: Casodex;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival |  | Throughout study period | 
| Time to clinical progression |  | Throughout study period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability in terms of adverse events and laboratory parameters |  | Throughout study period | 
| Time to treatment failure |  | Throughout study period | 
| Prostate-specific antigen |  | Initial study period up to 2005 amended protocol | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
androgen antagonists, prostate neoplasms
Blood Sample Collection and Health Information Collection From Patients With Invasive Breast Cancer and Their Brothers and Sisters

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Collecting blood samples and health information from patients with invasive breast cancer and from their brothers and sisters over time may help the study of cancer in the future. PURPOSE: This study is collecting blood samples and health information over time from patients with invasive breast cancer and from their brothers and sisters.

Detailed Description
-----------------
OBJECTIVES: Collect blood samples and medical and background information from patients with invasive breast cancer and their affected or unaffected siblings. OUTLINE: Patients and their siblings undergo blood collection. They also complete medical and background questionnaires. Patients and their siblings are followed annually for 5 years. PROJECTED ACCRUAL: A total of 1,000 patients and siblings will be accrued for this study.

Official Title
-----------------
Breast Cancer Siblings Database

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

Intervention / Treatment
-----------------
* Other: biologic sample preservation procedure
* Other: informational intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Meets 1 of the following criteria: Pathologically confirmed invasive breast cancer (patient) No ductal carcinoma in situ Affected OR unaffected sibling Affected sibling must have had (or currently has) breast cancer only Unaffected sibling must be female No deceased siblings Must be a full-blood related sibling Patients receiving treatment on clinical trial ECOG-E1Y97 or ECOG-E3Y92 are not eligible PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: Not specified

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: biologic sample preservation procedure|nan|
|Other: informational intervention|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collection of blood samples and medical and background information |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
male breast cancer, recurrent breast cancer, stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer
APRiCOT-L: Study to Evaluate Efficacy and Safety of Apricoxib With Erlotinib in Patients With Non-small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
This study will compare the anti-tumor efficacy of apricoxib and erlotinib with placebo and erlotinib as measured by time to disease progression to test the hypothesis that down regulation of COX-2 and EGFR pathways in patients with up-regulated COX-2 expression in tumor will have a clinical benefit compared with erlotinib alone.

Official Title
-----------------
APRiCOT-L (Apricoxib in Combination Oncology Treatment - Lung) A Randomized, Double-Blind, Placebo-Controlled Multicenter Phase 2 Study of the Efficacy and Safety of Apricoxib in Combination With Erlotinib in Non-Small Cell Lung Cancer Patients

Conditions
-----------------
Recurrent Non Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: apricoxib/erlotinib
* Drug: erlotinib/placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pathologically determined Stage IV NSCLC including Stage IIIb (pleural effusion) Failed at least one prior platinum-based chemotherapy for Stage IIIb or Stage IV NSCLC. Patients receiving platinum-based chemotherapy only given in an adjuvant setting are not eligible. Measurable disease by RECIST Greater than or equal to 18 years of age ECOG PS of 0 or 1 Exclusion Criteria: Radiation therapy within 2 weeks; chemotherapy within 3 weeks; non-cytotoxic investigational agents within 4 weeks of initiating study treatment Evidence of NYHA class III or greater cardiac disease History of MI, stroke, ventricular arrhythmia, or symptomatic conduction abnormality within 12 months Known HIV infection or AIDS Symptomatic CNS metastases Pregnant or nursing women Hypersensitivity or intolerance to erlotinib, sulfonamides, aspirin, or other NSAIDs. History of upper GI bleeding, ulceration, or perforation Prior history of COX-2 inhibitor therapy for the treatment of metastatic NSCLC Previous anti-EGFR kinase therapy

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: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: apricoxib/erlotinib<br>* apricoxib: 100 mg tablets, 400mg/day erlotinib: per package insert<br>|
| Placebo Comparator: B<br> | Drug: erlotinib/placebo<br>* erlotinib: per package insert placebo: 100 mg tablets, 400 mg/day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Disease Progression (TDP) |  | Baseline and every other cycle. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | Randomization and every cycle |
The Usefulness of Endoscopic Ultrasound-guided Biliary Drainage With a Newly Designed Hybrid Metallic Stent

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the feasibility and safety of endoscopic ultrasound-guided biliary drainage with a newly designed hybrid metallic stent.

Detailed Description
-----------------
Endoscopic ultrasound-guided biliary drainage with a fully covered metallic stent was a safe and effective method in patients with malignant biliary obstructions and had a comparatively long patency duration. Nevertheless, the significant rate of distal stent migration cannot be ignored, suggesting the need for a newly designed metallic stent for endoscopic ultrasound-guided biliary drainage.

Official Title
-----------------
Pilot Study on the Usefulness of Endoscopic Ultrasound-guided Biliary Drainage With a Newly Designed Hybrid Metallic Stent

Conditions
-----------------
Bile Duct Obstruction, Disorder of Bile Duct Stent, Neoplasms

Intervention / Treatment
-----------------
* Device: EUS-guided biliary drainage with a hybrid metallic stent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 20 years The presence of an unresectable malignant biliary obstruction Failed conventional ERCP stenting Exclusion Criteria: Age < 20 years An inability to sedate the patient due to advanced heart or pulmonary diseases A lack of informed consent

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: hybrid metallic stent<br>Patients group who were inserted a hybrid metallic stent | Device: EUS-guided biliary drainage with a hybrid metallic stent<br>* EUS-guided biliary drainage with a newly designed hybrid metallic stent<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The stent patency rate |  | Up to 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients' survival rate |  | Up to 48 weeks | 
| Complication rate related to the hybrid stents |  | Up to 48 weeks |
A Study of the Safety of REN001 in Patients With McArdle Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess REN001 safety in subjects with McArdle Disease

Official Title
-----------------
A Phase 1b, Open-label Study to Evaluate the Safety and Tolerability of 12 Weeks Treatment With Oral REN001 in Patients With McArdle Disease (Glycogen Storage Disorder 5)

Conditions
-----------------
McArdle Disease

Intervention / Treatment
-----------------
* Drug: REN001


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must give written, signed and dated informed consent Confirmed diagnosis of McArdle Disease Subjects must be able to remain on stable medication through the study and specifically must not commence or have changes to agents that affect metabolism such as medication for diabetes Follow a stable dietary regimen as documented by a 3-day dietary record obtained during the screening period. Exclusion Criteria: Documented history of ongoing rhabdomyolysis Evidence of acute crisis from their underlying disease Currently following or planning to start a ketogenic diet Treatment with an investigational drug within 1 month or within 5 half-lives, whichever is longer Have been hospitalized within the 3 months prior to screening for any major medical condition Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the Investigator in discussion with the Medical Monitor, would make the subject inappropriate for entry into this study Pregnant or nursing females

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 |
| --- | --- |
| Experimental: REN001<br>Oral | Drug: REN001<br>* Once daily for 12 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Number of participants with Adverse Events (AEs) as a measure of safety and tolerability | up to Week 12 |