linjc16/ctgov huggingface dataset:
Valproate Response in Aggressive Autistic Adolescents

Study Overview
=================
Brief Summary
-----------------
This study will examine the effect of valproate, a medication used to treat seizures and bipolar disorder, on aggressive behavior in children and adolescents with autism.

Detailed Description
-----------------
Autism is a complex biological disorder that generally lasts throughout a person's life. It starts before age three and causes delays or problems with many different ways in which a person develops or grows. Some people with autism become very aggressive and can hurt others or themselves. This study will test the hypothesis that aggressive autistic adolescents will show a significantly greater response to valproate maintained at blood levels of 75-100 mcg/ml than to placebo. The study will also assess the safety of valproate in autistic adolescents. This represents the first double-blind study of valproate in mentally retarded/developmentally delayed populations. Participants in this study will undergo DSM-IV evaluation, the Autism Diagnostic Interview-Revised and Autism Diagnostic Observation Schedule, and baseline blood tests. After baseline screening, all participants will be given a placebo for 1 week. Participants will then be randomized to receive either valproate or placebo for 8 weeks. Dosage adjustment according to blood levels drawn at the end of weeks 2 and 4 will be arranged with parents by a child psychiatrist without breaking the blind. The Aberrant Behavior Check-list-Community (ABC-C) irritability subscale will be the primary measure; the Overt Aggression Scale (OAS), ABC-C hyperactivity subscale, Clinical Global Impressions (CGI) problem severity, Self-Injurious Behavior Questionnaire (SIB-Q), and a valproate side effects checklist will be secondary measures.

Official Title
-----------------
Valproate Response in Aggressive Autistic Adolescents

Conditions
-----------------
Autism

Intervention / Treatment
-----------------
* Drug: Valproate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Autism Lives in the Kansas City area Exclusion Criteria Psychoactive maintenance medication Degenerative central nervous system disorder Unstable medical illness Seizures in the 6 months prior to study entry History of valproate sensitivity or previous liver disease History of ovarian cysts Low platelet count or raised liver transaminases

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 21 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: Factorial Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Valproate|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
-----------------
Adolescents
Up-positioning of the Testes as Supportive Therapy in Patients With Acute Orchitis

Study Overview
=================
Brief Summary
-----------------
This is a single-blinded RCT evaluating the value of up-positioning of the testes as supportive therapy in patients receiving antimicrobial treatment due to acute bacterial orchitis.

Official Title
-----------------
Up-positioning of the Testes as Supportive Therapy in Patients With Acute Orchitis - a Randomized Controlled Trial

Conditions
-----------------
Orchitis, Testicular Diseases

Intervention / Treatment
-----------------
* Behavioral: Up-positioning of the testes


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: acute orchitis confirmed clinically and in scrotal ultrasound age >=18 yrs Exclusion Criteria: previous treatment of orchitis, need for exploration of the scrotum, need for hospitalization, physical and mental status not allowing for up-positioning of the testes during treatment

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Up-positioning of the testes<br>Patients receive standard medical therapy and supportive therapy | Behavioral: Up-positioning of the testes<br>* Patients in the experimental arm are asked to elevate their testes during the treatment.<br>|
| No Intervention: Medical therapy only<br>Patients receive standard medical therapy only | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to alleviation of symptoms |  | 10 days | 
| Time to clinical resolution of local symptoms |  | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Testicular pain |  | 10 days | 
| Testicular swelling |  | 10 days | 
| Testicular erythema |  | 10 days | 
| Scrotal pain intensity |  | 10 days | 
| Quality of life |  | 10 days | 
| Body temperature |  | 10 days | 
| Heart rate |  | 10 days | 
| Duration of up-positioning of testes per day |  | 10 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
orchitis, testicular diseases
Endoscopic Treatment of Recurrent Upper GI Bleeding: OTSC [Over the Scope Clip] Versus Standard Therapy

Study Overview
=================
Brief Summary
-----------------
Prospective-randomized trial. Patients with recurrent bleeding from gastroduodenal ulcers are randomized into either endoscopic treatment with the OTSC [Over The Scope Clip] or endoscopic standard therapy. Hypothesis: Endoscopic therapy with OTSC is superior to standard therapy regarding technical success and rebleeding.

Official Title
-----------------
Endoscopic Treatment of Recurrent Upper GI Bleeding From Gastroduodenal Ulcers: OTSC [Over the Scope Clip] Versus Standard Therapy

Conditions
-----------------
Acute Upper Gastrointestinal Hemorrhage

Intervention / Treatment
-----------------
* Device: Endoscopic hemostasis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Recurrence of bleeding from gastroduodenal ulcers Exclusion Criteria: Malignant ulcers, variceal bleeding, patients younger than 18 years, lesions not suitable for treatment with OTSC

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Therapy<br>Endoscopic therapy with Standard Clip + injection of epinephrine solution or thermal therapy + injection of epinephrin-solution | Device: Endoscopic hemostasis<br>* Hemostasis with Standard Therapy (standard clip or thermal therapy + injection of adrenaline solution) or by application of the Over The Scope Clip and injection of adrenaline solution<br>|
| Experimental: OTSC (Over The Scope Clip)<br>Endoscopic therapy with Application of OTSC Clip and Injection of epinephrin-solution | Device: Endoscopic hemostasis<br>* Hemostasis with Standard Therapy (standard clip or thermal therapy + injection of adrenaline solution) or by application of the Over The Scope Clip and injection of adrenaline solution<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Persistent bleeding or Rebleeding with 7 days |  | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood units transfused |  | 30 days | 
| duration of hospital stay |  | 30 days | 
| duration of intensive care unit stay |  | 30 days | 
| 30 d Mortality |  | 30 days | 
| Amount of endoscopic reinterventions |  | 7 d | 
| Necessity of surgical or angiographic therapy |  | 7 d | 
| Complications during or after OTSC (Over The Scope Clip) placement |  | 7 d | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
OTSC, Upper gastrointestinal bleeding
Implantable System for Remodulin Post-Approval Study

Study Overview
=================
Brief Summary
-----------------
The purpose of the Implantable System for Remodulin (ISR) Post Approval Study (PAS) is to provide evaluation and periodic reporting of the safety and effectiveness of Medtronic market-released ISR, including the catheter and the pump.

Detailed Description
-----------------
The ISR PAS is an observational, prospective, non-randomized, multi-center study. It will enroll a minimum of 50 newly implanted patients at up to 10 US sites, observing and reporting catheter-related complications and pump failures through 5 years post implant.

Official Title
-----------------
Implantable System for Remodulin Post-Approval Study

Conditions
-----------------
Pulmonary Arterial Hypertension

Intervention / Treatment
-----------------
* Combination Product: Implantable System for Remodulin (treprostinil)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject or legally authorized representative provides written authorization and/or consent per institution and geographical requirements. Subject is intended to receive an eligible ISR product. Subject is at least 22 years of age. Exclusion Criteria: Subject is pregnant. Subject who is expected to be inaccessible for follow-up. Subject with exclusion criteria required by local law. Subject is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results (i.e. no required intervention that could affect interpretation of all-around product safety and or effectiveness).

Ages Eligible for Study
-----------------
Minimum Age: 22 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Combination Product: Implantable System for Remodulin (treprostinil)|All patients will be implanted with the Implantable System for Remodulin (treprostinil).|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Catheter-related complications | Number of adverse events requiring invasive intervention that are related to the ISR catheter. | Implant to 5 years post-implant | 
| Pump failures | Number of adverse events requiring invasive intervention that are related to the ISR pump. | Implant to 5 years post-implant | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PAH, Pulmonary Arterial Hypertension, Pulmonary Hypertension, Remodulin, treprostinil, DelIVery for PAH, Implantable Pump, Drug Pump, Intrathecal Catheter, Targeted Drug Delivery, Programmable Pump
Borrelia Species in Cutaneous Lyme Borreliosis

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to identify the species of Borrelia involved in the dermatologic manifestations of Lyme borreliosis in France. Indeed, in Europe, as opposed to North America, many bacterial species are involved in Lyme borreliosis. Yet, very few is known about the prevalence and distribution of different bacteriological species that account for the disease in France. Thus, this a nation-wide study in which all French dermatologists are invited to participate. Every adult patient presenting with one of the cutaneous manifestation of Lyme borreliosis: erythema migrans, lymphocytoma or acrodermatitis chronica atrophicans can be included in the study. If the patient agrees participating, after information and written consent, a cutaneous biopsy will be performed in order to isolate Borrelia by means of culture and PCR. An estimated 400 biopsies should be performed within 2 years.

Official Title
-----------------
DIVERSITY OF BORRELIA SPECIES INVOLVED IN CUTANEOUS MANIFESTATIONS OF LYME BORRELIOSIS IN FRANCE

Conditions
-----------------
Lyme Borreliosis

Intervention / Treatment
-----------------
* Other: Cutaneous biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Informed adult patient who signed written consent with one the following conditions: erythema migrans borrelial lymphocytoma acrodermatitis chronica atrophicans Exclusion criteria: pregnancy or lactation allergy to local anesthesia patient who refuses biopsy

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

| Intervention/Treatment |
| --- |
|Other: Cutaneous biopsy|Cutaneous biopsy in order to search Borrelia by means of culture and PCR in this tissue sample|

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
-----------------
Lyme borreliosis, Erythema migrans, Borrelial lymphocytoma, Acrodermatitis chronica atrophicans, Borrelia burgdorferi, Borrelia afzelii, Borrelia garinii
Data Bank for Eosinophilic Disorders

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to conduct a translational study in patients with primary eosinophil associated gastrointestinal disorders [EGID] (e.g. eosinophilic esophagitis eosinophilic gastritis, eosinophilic enteritis [EE], eosinophilic colitis, and eosinophilic gastroenteritis [EGE]) with the aim of developing a data bank containing pertinent patient demographic information, tissue samples, and DNA, which will facilitate research on the pathophysiology of inflammatory disorders and the development of a verified successful clinical treatment program.

Official Title
-----------------
Clinical and Immunological Evaluation of Eosinophil Associated Gastrointestinal Disorders (EGID)

Conditions
-----------------
Gastritis, Eosinophilic Esophagitis, Enteritis, Eosinophilic Colitis, Eosinophilic Gastroenteritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Patients with an eosinophil associated gastrointestinal disorder (EGID), family members of patients with EGID, or normal controls.
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
eosinophilic esophagitis, eosinophilic gastritis, eosinophilic enteritis, eosinophilic colitis, eosinophilic gastroenteritis
HBRN: Immune Regulation and Costimulation in Natural History and Therapeutic Outcome of Chronic Hepatitis B

Study Overview
=================
Brief Summary
-----------------
This is an ancillary to the NIDDK-sponsored treatment trials titled: Combination Therapy of Pegylated Interferon Alfa-2a and Tenofovir Versus Tenofovir Monotherapy in Chronic Hepatitis B (NCT01369212) and Combination Entecavir and Peginterferon Therapy in HBeAg-Positive Immune-Tolerant Adults With Chronic Hepatitis B (NCT01369199). This study will examine the balance between immune regulatory and effector responses in hepatitis B-infected participants enrolled in the HBRN's clinical trials (NCT01369212 and NCT01369199) to define natural history and treatment outcome.

Detailed Description
-----------------
Aim 1. Therapeutic HBV suppression will enhance antiviral immune effector responses and reduce immune inhibitory factors in participants with chronic hepatitis B. This study will also examine if antiviral therapy has a durable effect in host immune phenotype and define the immunological effect of interferon-alpha (IFNα) therapy in chronic HBV participants. Aim 2. Antiviral immune effector and regulatory responses before, during and/or after therapy can predict long term therapeutic response.

Official Title
-----------------
HBRN: Immune Regulation and Costimulation in Natural History and Therapeutic Outcome of Chronic Hepatitis B

Conditions
-----------------
Hepatitis B

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ability to provide informed consent for participation in the ancillary study Exclusion Criteria: Children under 18 years of age Pregnant women Participants with anemia (Hgb<10 or Hct<30) Participants with active medical conditions such as congestive heart failure or chronic lung disease requiring oxygen, active coronary artery disease with unstable angina, sepsis and renal failure Participants with significant medical conditions, autoimmune disease or immunosuppression

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 |
| --- | --- | --- |
| Immune regulatory and effector responses relative to HBV DNA, ALT and clinical outcome | HBV-specific lymphoproliferative, IFN-gamma and IL10 responses, T cell activation and costimulatory markers ( PD1, CTLA4, CD28, CD127), FoxP3+ Treg frequency, and NK frequency and expression of activating/inhibitory receptors Dendritic cell frequency | up to 192 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatitis B, Immunology, HBV, Immune tolerant, Immune active
Influence of Perioperative Fluid Balance on Serum Concentrations of Antibiotics and Surgical Site Infections

Study Overview
=================
Brief Summary
-----------------
This study evaluates antibiotic serum concentrations in correlation with perioperative fluid balance. Patients will be recruited in rectum and esophageal surgery (representative for low blood loss and restrictive fluid management) and in liver surgery (representative for high blood loss and liberal fluid management). The hypothesis is that high blood loss and liberal fluid management dilute antibiotic serum concentrations thereby potentially increasing surgical site infections.

Official Title
-----------------
Influence of Perioperative Fluid Balance on Serum Concentrations of Antibiotics and Surgical Site Infections

Conditions
-----------------
Antibiotic, Anti-Bacterial Agents, Surgical Wound Infection

Intervention / Treatment
-----------------
* Procedure: Blood sampling after antibiotic administration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: elective surgery of rectom, esophagus or liver with indication for a central venous catheter informed consent Exclusion Criteria: pregnancy medical emergency participation in another study

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Blood sampling after antibiotic administration|Sampling of 6 x 8 mL (in sum 48 mL) via the central venous line (established for the surgical procedure) until postoperative day 2|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum concentration of antibiotic | ug/mL | 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical wound infection | Incidence | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Surgical wound infection, antibiotic concentration, blood level
Pharmaco-Economic Study of Treatment Options in Patients With Advanced RCC

Study Overview
=================
Brief Summary
-----------------
This is a retrospective cohort study aiming to collect data on patients' characteristics, resource utilization, adverse events management and calculate costs attributed to current treatments of advance RCC patients who have received at least one prior VEGF-targeted therapy in Taiwan from National Health Insurance (NHI) perspective.

Official Title
-----------------
Patients Characteristics, Treatment Utilization, Costs and Outcomes in Patients With Advanced or Metastatic Renal Cell Carcinoma (RCC) Who Received at Least One Prior Vascular Endothelial Growth Factor (VEGF)-Targeted Therapy in Taiwan

Conditions
-----------------
Renal Cell Carcinoma Metastatic, Renal Cell Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with confirmed diagnosis of clear-cell renal cell carcinoma Patients with evidence of metastatic disease Patients who have received at least one previous VEGFR-targeted therapy, i.e sunitinib, pazopanib or sorafenib Patients who received care at the selected medical centers, utilizing the National Health Insurance (NHI) reimbursed system at the time of the disease Exclusion Criteria: Patients enrolled in any clinical trial involving anti-cancer therapy Pregnant woman

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 |
| --- | --- | --- |
| Medication usage |  | From start point for 2.5 months | 
| Treatment's duration |  | From start point for 2.5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost of medication used |  | From start point for 2.5 months | 
| Costs of adverse event management | (total calculated costs attributed to Adverse Effects (AEs) management according to the attached list of adverse events | From start point for 2.5 months | 
| Frequency of health resource usage | Outpatient department visits, CT scan, blood test number and types | From start point for 2.5 months | 
| Cost of health resource usage | Outpatient department visits, CT scan, blood test number and types | From start point for 2.5 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
advanced or metastatic renal cell carcinoma (RCC)