linjc16/ctgov huggingface dataset:
Acceptance-Based Treatment for Generalized Anxiety Disorder

Study Overview
=================
Brief Summary
-----------------
This study will develop and implement an awareness- and acceptance-based for treatment of individuals with generalized anxiety disorder.

Detailed Description
-----------------
Participants in this study are recruited from intakes at the Center for Anxiety and Related Disorders at Boston University. Participants will be randomly assigned to receive either acceptance and mindfulness-based strategies plus cognitive behavioral therapy or no treatment for 16 weeks. The treatment will involve daily practice of mindfulness techniques to help draw attention to and accept various emotional states. Interviews, questionnaires, and depression and anxiety scales will be used to assess participants. Assessments will be conducted post-treatment and at 3- and 9-month follow-up visits.

Official Title
-----------------
Developing a New Therapy for GAD: Acceptance-Based CBT

Conditions
-----------------
Anxiety Disorders, Generalized Anxiety Disorder

Intervention / Treatment
-----------------
* Behavioral: Acceptance Based Behavioral Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Generalized Anxiety Disorder (GAD) Willing to maintain medication levels and refrain from any additional psychosocial treatment during the course of the study Exclusion Criteria: Bipolar disorder, psychotic disorder, or substance dependence

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: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Acceptance Based Behavioral Therapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinician Severity Rating from ADIS for GAD |  | pre, post, 3 mo. f/u, 9 mo. f/u | 
| Penn State Worry Questionnaire |  | pre-, post-, 3 mo. f/u, 9 mo. f/u | 
| Depression Anxiety and Stress Scales, anxiety and stress subscales |  | pre-, post-, 3 mo. f/u, 9 mo. f/u |
Association of Periostin Levels and Chronic Sinusitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see if a protein in blood, called periostin, can determine if patients have chronic sinusitis. This protein is in everyone's body, but the level of the protein may indicate certain conditions such as chronic sinusitis. The investigators are interested in testing levels of periostin to see if they are higher or lower than patients without chronic sinusitis, just as periostin is higher in patients with asthma. All patients enrolled in this study will have chronic sinusitis without asthma.

Official Title
-----------------
Association of Periostin Levels and Chronic Sinusitis

Conditions
-----------------
Sinusitis, Nasal Polyps

Intervention / Treatment
-----------------
* Other: Blood draw


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with sinus disease which requires surgical intervention Ability to understand and give informed consent Exclusion Criteria: Previous diagnosis of asthma Positive methacholine challenge at screening Diagnosis of cystic fibrosis Concomitant use of systemic corticosteroids (except for those prescribed as part of standard pre-surgical treatment)

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects who require sinus surgery<br> | Other: Blood draw<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in circulating serum periostin levels pre and post sinus surgery | Serum collected prior to and following sinus surgery will be analyzed for concentrations of the protein periostin. | 10-15 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nasal Polyps, Chronic sinusitis
A Study of Stavudine in HIV-Infected Patients Who Have Not Had Success With Other Anti-HIV Drugs

Study Overview
=================
Brief Summary
-----------------
To make stavudine (d4T) available to patients with advanced HIV disease for whom no alternative antiretroviral is satisfactory. To study the safety and efficacy of two dose levels in a twice-daily regimen.

Official Title
-----------------
A Randomized Blinded Evaluation of Two Doses of Stavudine (2',3'-Didehydro-2',3'-Dideoxythymidine; d4T) to Make Treatment Available to Severely Immunocompromised Patients With HIV Infection Who Have Failed or Are Intolerant of Alternative Antiretroviral Therapy

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Stavudine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must have: HIV positivity with CD4 count < 300 cells/mm3. Intolerance to or failure on approved antiretroviral therapy. Ability to provide informed consent (of parent or guardian if appropriate). NOTE: Incarcerated persons may be eligible to participate. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Grade 2 or worse disease-related peripheral neuropathy. Unresolved drug-related peripheral neuropathy of any severity that is attributable to other nucleoside analogs (AZT, ddC, ddI). Malignancy likely to require systemic chemotherapy with myelosuppressive or neurotoxic drugs in the first 3 months of stavudine treatment. Pregnancy (physicians of pregnant patients may contact Bristol-Myers to determine eligibility for stavudine therapy in another protocol). Strongly discouraged: AZT, ddI, ddC, and other antiretroviral agents.

Ages Eligible for Study
-----------------
Minimum Age: 13 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: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Stavudine|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
-----------------
Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Stavudine
Genetics of Rolandic Epilepsy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to find the genes that cause Rolandic epilepsy and its related traits.

Detailed Description
-----------------
Rolandic epilepsy (RE) is the most common type of childhood epilepsy-affecting more than 50,000 children in the United States-and has a complex genetic inheritance. The seizure prognosis is relatively benign, however, many children with RE also have problems with speech and language, reading, and motor coordination. Symptoms of the disorder overlap with more severe types of epilepsy. The purpose of this study is to find the genes that influence RE and its related traits. Identifying genetic causes for the variants would improve diagnosis and allow for early intervention. Researchers will enroll 1000 children with RE and 3000 controls for participation in the study. The scientists will request medical histories and (salivary) DNA samples from the participants. Participation can be completed by mail and telephone. Results from this study should provide important information regarding diagnosis and prognosis of RE, may be useful in clinical management, and, eventually, may lead to a cure for this and other forms of epilepsy.

Official Title
-----------------
Genetics of Rolandic Epilepsy

Conditions
-----------------
Epilepsy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: typical history of focal seizures EEG centrotemporal sharp waves age of onset 3-12 years no previous epilepsy type (febrile seizures OK) normal development normal neurological examination normal MRI/CT (if done) Exclusion: only history of secondary generalized seizures atypical history/semiology history and EEG inconsistent abnormal EEG background very early (<3yrs) or late (>12yrs) onset global neurodevelopmental deficit deviant neurodevelopment structural imaging abnormality

Ages Eligible for Study
-----------------
Minimum Age: 3 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 |
| --- | --- |
| Group I: Cases<br>Children with rolandic epilepsy | |
| Group II: Controls<br>Individuals group matched to cases for ethnicity, sex and area of residence but lacking a primary brain disorder. | |

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
-----------------
epilepsy, Rolandic epilepsy
Prevalence of Pathologic Gambling in the Workforce: a Cross-sectional Study in Brittany, France

Study Overview
=================
Brief Summary
-----------------
Introduction: To date, very few studies about links between work and addictive disorders concern behavioral addictive disorders such as gambling. Such behaviours may be adaptative strategy for unsatisfied workers. The common physiopathology of addictive disorders allows us to hypothesize that it is possible that such troubles at work could promote gambling. Our aim was to evaluate the prevalence of gambling among workers and its links with work. Patients and methods: We performed a descriptive cross-sectional monocentric study among all workers who consulted one physician between November 2016 and April 2017, from an occupational health service in Brittany, France. The first step was to ask whether they have gambled during the last year and if it was related to their occupation. The second step was a screening for risky gamblers (using the Lie or Bet questionnaire) among these and then to assess more precisely the severity (using the Indice Canadien du Jeu Excessif, ICJE questionnaire).

Official Title
-----------------
Prevalence of Pathologic Gambling in the Workforce: a Cross-sectional Study in Brittany, France

Conditions
-----------------
Behavior and Behavior Mechanisms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all employees coming in consultation in occupational medicine, between the 2016-11-01 and the 2017-04-30, with the investigator, having given their consent and replied to the questionnaires were included. Exclusion Criteria: Employees who did not speak the French language and those who refused to participate in the study were excluded. The number of refusals to participate and their reason were identified by the investigator. In addition, for employees who came to consult several times during the collection period, we only included the data from the first visit, in order to avoid overrepresentation.

Ages Eligible for Study
-----------------
Minimum Age: 15 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 |
| --- | --- | --- |
| Gambling prevalence |  | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| link between workand gambling |  | 6 month | 
| type of game |  | 6 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gambing, occupational health services, psychosocial risks
Parecoxib in Renal Colic

Study Overview
=================
Brief Summary
-----------------
This is a phase III, multicenter, randomized, single blind study designed to evaluate the efficacy and tolerability of a single dose of parecoxib compared with diclofenac in the treatment of acute pain due to renal colic.

Detailed Description
-----------------
This study was prematurely discontinued May 3, 2004 due to slow recruitment. The decision to terminate the trial was not based on any safety concerns.

Official Title
-----------------
A Multicenter Single-Blind, Single Dose Efficacy and Safety Pilot Study Comparing Intramuscular Parecoxib and Diclofenac in Renal Colic

Conditions
-----------------
Colic

Intervention / Treatment
-----------------
* Drug: Parecoxib
* Drug: Diclofenac


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of renal colic; baseline pain > 50 mm on VAS; Exclusion Criteria: evidence of neoplasm or any other severe disease of any organ, including any psychiatric illness; active GI disease (e.g. Crohn's disease or ulcerative colitis) or any evidence of concomitant disease which may lead to early termination of the study

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?
-----------------

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Parecoxib|nan|
|Drug: Diclofenac|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of efficacy through: time to onset of pain relief and time to remedication. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of efficacy through: Pain Intensity (VAS), Pain Relief (PR) and several measurements of analgesia that will be derived from VAS and PR Physician's Global Evaluation at 12 hours Patient's Global Evaluation at 12 hours |  |  |
Establishment of an Algorithm for a Clinical Classfication of Hypoosmolar Hyponatremia

Study Overview
=================
Brief Summary
-----------------
The prospective clinical diagnosis of hyponatremia is often very difficult- but requirement for an appropriate and riskless treatment of hyponatremia. This study try to establish an algorithm handling a prospective clinical categorization of hyponatremia and approving together the start of an appropriate symptomatic therapy.

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hypoosmolar hyponatremia with serum sodium concentration ≤129 mmol/l and serum osmolality ≤ 280 mosm/kg; age > 18 years; letter of agreement. Exclusion Criteria: gravidity and lactation; restricted decision-making-ability

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Establishment of an clinical algorithm to differentiate the different causes of hyponatremia |  | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hyponatremia, diagnosis and treatment of hyponatremia, classification of hyponatremia
CU Programme of Idarucizumab for Japanese Patients

Study Overview
=================
Brief Summary
-----------------
The objective is to collect the safety data of idarucizumab for patients treated with dabigatran who require rapid reversal of the anticoagulant effects of dabigatran in cases of uncontrolled or life-threatening bleeding or when emergency surgery or urgent procedures are required.

Official Title
-----------------
A Compassionate Use Program of Idarucizumab for Reversal of the Anticoagulant Effects of Dabigatran in Japanese Patients Who Have Uncontrolled Bleeding or Require Emergency Surgery or Procedures

Conditions
-----------------
Hemorrhage

Intervention / Treatment
-----------------
* Drug: idarucizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Currently taking dabigatran etexilate. Age >= 20 years at entry. Written Informed consent Group A: -- Uncontrolled or life-threatening judged by the physician to require a reversal agent. Group B: A condition requiring emergency surgery or invasive procedure where adequate hemostasis is required. Emergency is defined as within the following 8 hours. Exclusion criteria: Contraindications to study medication including known hypersensitivity to the drug or its excipients (subjects with hereditary fructose intolerance may react to sorbitol). Group A: Patients with minor bleeding (e.g. epistaxis, hematuria) who can be managed with standard supportive care. Patients with no clinical signs of bleeding. Group B: surgery or procedure which is elective or where the risk of uncontrolled or unmanageable bleeding is low.

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: idarucizumab<br> | Drug: idarucizumab<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects With Drug-related Adverse Events | Percentage of subjects with drug-related adverse events is presented | from first drug administration until 5 days after last drug administration, up to 6 days. |
Influenza Vaccination Digital Interventions for People Living With Diabetes

Study Overview
=================
Brief Summary
-----------------
The overall objective of this prospective randomized controlled study is to assess and quantify the impact of digital interventions to increase vaccination rates and vaccination-related outcomes in a connected population with self-reported diabetes. The digital intervention will be delivered via a campaign sent to participants, with interventions varying with each study arm. Participants will be blinded to study participation status.

Official Title
-----------------
Influenza Vaccination Digital Interventions for People Living With Diabetes

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Behavioral: Diabetes Digital Intervention
* Behavioral: Generic Digital Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 18 years old Lives in the U.S. Exclusion Criteria: < 18 years old Does not live in the U.S.

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?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diabetes Digital Intervention<br> | Behavioral: Diabetes Digital Intervention<br>* The Diabetes Digital Intervention is a digital campaign that provides interactive ways (e.g., videos, infographics, quizzes) for individuals to learn about influenza and related complications, and the importance of influenza vaccination. It is tailored to people living with diabetes and highlights the importance of influenza vaccination for this specific patient population.<br>|
| Experimental: Generic Digital Intervention<br> | Behavioral: Generic Digital Intervention<br>* The Generic Digital Intervention is a digital campaign that provides interactive ways (e.g., videos, infographics, quizzes) for individuals to learn about influenza and related complications, and the importance of influenza vaccination. It provides generic influenza vaccination interventions that can be applicable to any adult who should receive influenza vaccination.<br>|
| No Intervention: No Influenza Vaccination Intervention<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Self-reported Influenza Vaccination in People With Diabetes | Number of participants with self-reported influenza vaccination in People With Diabetes: Intervention arm as compared to People With Diabetes: Control arm | 6 months |