linjc16/ctgov huggingface dataset:
Clinical Trial on Binge Eating Disorder, Treatment With Naloxone Spray

Study Overview
=================
Brief Summary
-----------------
The investigators are studying a new treatment for one subtype of obesity. Obesity is not a disease. It is a symptom of several different diseases. These diseases have distinct etiologies, being caused by aberrations in different mechanisms. Forms of obesity caused by such non-critical mechanisms might be corrected fairly easily and safely. The investigators are interested in overeating and obesity that is caused by the opioidergic system. The opioidergic system appears to be responsible for a subtype of obesity associated with binge eating disorder (BED). People, especially with the right genetic predisposition, can become addicted to foods that release endorphins, in the way that people become addicted to exogenous opiates and other drugs that release endorphins. The particular application in our proposed clinical trial is for intranasal (IN) naloxone. The peak levels of naloxone were similar and the bioavailability of naloxone intranasally was 100% (the same) of that available IV. IN administration of naloxone has since been broadly tested in humans, as well, where it has been shown to be safe, with pharmacokinetics similar to those of naloxone given by injection .

Official Title
-----------------
Clinical Controlled Trial on Extinction of Opioidergic Binge Eating Disorder (BED) With Intranasal Naloxone Administration

Conditions
-----------------
Binge Eating Disorder

Intervention / Treatment
-----------------
* Drug: Naloxone
* Drug: naloxone placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Binge eating disorder (DSM-IV) and body mass index (BMI) > 25 Binge eating screen > 20 Exclusion Criteria: Pregnancy Drug usage Retarded Severe mental illness

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: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Naloxone<br>nasal spray before binging, naloxone dose 2 mg, maximum daily dose 4 mg | Drug: Naloxone<br>* 2 mg x 1-2<br>|
| Placebo Comparator: nasal spray<br>nasal placebo (h2o) spray before binging, max sprays / day | Drug: naloxone placebo<br>* h2o placebo spray<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in frequency of binge eating |  | 0 and 24 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Becks depression inventory (BDI) |  | -1,0, 24 weeks | 
| Analogic binge eating craving scale (BES-VAS) |  | -1,0,24 weeks | 
| Binge eating severity scale (BES) |  | -1,0,24 weeks |
Biomarkers in Samples From Patients With B-Cell Acute Lymphoblastic Leukemia

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. PURPOSE: This research study is studying biomarkers in samples from patients with acute lymphoblastic leukemia enrolled on ECOG-2993 clinical trial.

Detailed Description
-----------------
OBJECTIVES: To identify microRNAs that behave as oncogenes or as tumor suppressor genes in B-lineage acute lymphoblastic leukemia (ALL) in vitro and in vivo. To examine if single microRNA or signatures of microRNA correspond to different clinical outcomes in cytogenetically distinct B-ALL groups. OUTLINE: RNA from archived samples are analyzed for microRNA expression profile in vitro and in vivo.

Official Title
-----------------
Micro RNA Expression Analysis in B-Lineage Adult Acute Lymphoblastic Leukemia From ALL Trial, E2993, Including Patients With Various Cytogenetic and Molecular Abnormalities

Conditions
-----------------
Leukemia

Intervention / Treatment
-----------------
* Genetic: RNA analysis
* Genetic: cytogenetic analysis
* Genetic: microarray analysis
* Other: laboratory biomarker analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Samples from patients enrolled on ECOG-2993 Samples from patients with recurrent cytogenetic abnormalities other than BCR-ABL, including MLL/AF4, E2A/PBX1, and TEL/AML1 PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: Not specified

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 65 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: RNA analysis|nan|
|Genetic: cytogenetic analysis|nan|
|Genetic: microarray analysis|nan|
|Other: laboratory biomarker analysis|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comprehensive view of microRNA expression by cytogenetic subgroup |  | 1 year | 
| MicroRNA expression in relation to clinical outcome |  | 1 year | 
| Differential microRNA expression between normal B-cells and progenitors compared to B-ALL |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adult acute lymphoblastic leukemia in remission, B-cell adult acute lymphoblastic leukemia
Observational Study of Vismodegib (Erivedge) in Patients Treated in Argentina

Study Overview
=================
Brief Summary
-----------------
This observational, noninterventional study is designed to further characterize the effectiveness and safety profile of vismodegib (Erivedge) in Argentine patients. Only patients with locally advanced basal cell carcinoma (laBCC) or metastatic basal cell carcinoma (mBCC) will be considered in the effectiveness analysis. Study duration is estimated to be approximately 12 months.

Official Title
-----------------
Observational Study of the Effectiveness and Safety of Vismodegib (Erivedge) in Patients Treated in Argentina

Conditions
-----------------
Basal Cell Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Argetine patients prescribed vismodegib according to standard of care and in line with Summary of Product Characteristics (SPC) and local labeling Diagnosis of laBCC or mBCC for the effectiveness analysis Exclusion Criteria: None specified
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study Population<br>Patients who are prescribed vismodegib in Argentina, according to standard of care and in line with the current SPC and local labeling, are eligible for observation. Dosing and treatment duration of vismodegib are at the discretion of the physician in accordance with local clinical practice and local labeling. Only patients with laBCC or mBCC will be considered in the effectiveness analysis. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate as assessed by the treating physician |  | Approximately 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of treatment |  | Approximately 12 months | 
| Duration of response as assessed by the treating physician |  | Approximately 12 months | 
| Incidence of adverse events |  | Approximately 12 months |
The Effect Of Light On Scar Appearance

Study Overview
=================
Brief Summary
-----------------
The goal of this project is to examine the ability of light exposure to improve the appearance of cutaneous scars.

Detailed Description
-----------------
Light would be efficacious in improving scar appearance due to its known effects on wound healing, acne, and its use for skin rejuvenation. Light interacts with cells and stimulates the production of new collagen and elastin. This same energy can be used to inhibit collagen formation and help improve scars.

Official Title
-----------------
The Effect Of Light On Scar Appearance

Conditions
-----------------
Cutaneous Scars

Intervention / Treatment
-----------------
* Device: no intervention
* Device: light


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have two lesions that have been selected for excision Have two cutaneous scars from previous excisions as part of a standard of care Subjects are in good health Subject has a willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator Exclusion Criteria: Pregnancy or lactation Subjects who are unable to understand the protocol or to give informed consent Subjects with mental illness

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 |
| --- | --- |
| Experimental: A<br>scars will be treated with light | Device: light<br>* scars will be treated with light<br>|
| Placebo Comparator: B<br>no intervention | Device: no intervention<br>* no intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scar vascularity |  | 24 weeks | 
| Scar pigmentation |  | 24 weeks | 
| Scar thickness |  | 24 weeks | 
| Scar length |  | 24 weeks | 
| Scar width |  | 24 weeks | 
| Scar surface area |  | 24 weeks |
Mother to Child Transmission of Antibody to Covid-19 The TRAB CoV-19 Study.

Study Overview
=================
Brief Summary
-----------------
This is a prospective clinical study aiming to investigate on the transplacental antibody transmission post Covid-19 infection during pregnancy.

Detailed Description
-----------------
Covid -19 infection has been a significant public health burden as it shifted the paradigm of infectious diseases aiming to control the spread and enhance public immune protection. The introduction of Covid -19 vaccination in December 2020 aimed to combat the infection, thus tremendously helping to flatten the disease worldwide. Channeling the vaccine for the obstetrics field is one of the hallmark strategies to reduce maternal morbidity and mortality. The efficacy of vaccination for the pregnant lady has been established. However, fetus protection via transmission of the antibody during pregnancy is still uncertain. Therefore, this study aims to consolidate further evidence of transplacental antibody post-maternal vaccination aiming for fetal protection following delivery.

Official Title
-----------------
Maternal to Neonatal Transmission Antibody Covid-19 Study - The TRAB CoV-19

Conditions
-----------------
Antibody, Vaccine, Maternal, Cord

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: term pregnancies at 37 weeks or more vaccinated 2 doses in labour Exclusion Criteria: unvaccinated preterm labour less than 37 weeks multiple pregnancies

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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 |
| --- | --- | --- |
| Maternal to Neonatal Transmission Antibody Covid-19 Study - The TRAB CoV-19 | Quantification of Covid-19 antibody levels in maternal and cord blood samples | 30 minutes after delivery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Covid-19, antibody, pregnancy
Low Dose Naltrexone for the Treatment of Juvenile Primary Fibromyalgia Syndrome

Study Overview
=================
Brief Summary
-----------------
The purpose of this research is to obtain data or information on the safety and effectiveness of low dose naltrexone (LDN) for treating the symptoms of juvenile primary fibromyalgia syndrome. This is a dose finding study to find whether LDN helps the symptoms of juvenile fibromyalgia, and at what dose it does so.

Detailed Description
-----------------
In this pilot dosage-finding and efficacy study, we will experimentally test whether LDN reduces the symptoms of JPFS. We will recruit 40 children with JPFS. Participants will be screened via the JPFS criteria of Yunus and Masi. The study will be an open-label test of various doses of LDN to determine whether LDN reduces JPFS symptoms, and the appropriate dose at which it does so. Primary endpoints will be daily pain, fatigue, and sleep. The protocol is designed to take 18 weeks. There are a total of 10 study visits, taking place approximately every 2 weeks.

Official Title
-----------------
Low Dose Naltrexone for the Treatment of Juvenile Primary Fibromyalgia Syndrome

Conditions
-----------------
Fibromyalgia

Intervention / Treatment
-----------------
* Drug: Low Dose Naltrexone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:1. Generalized musculoskeletal aching for over 3 months duration 2. Moderate-severe pain in 5 of 11 tender points 3. Age 7 - 17 4. Male or female Exclusion Criteria:1. Diagnosed rheumatic or autoimmune condition contributing to pain 2. Abnormal laboratory results (Rf, ANA, ESR) 3. Use of opioid analgesics in the last 6 months 4. Severe depression and/or anxiety as evidenced by a diagnosis of either disorder, or by evidence based on a clinical interview with the patient and parent at the time of screening. 5. Current or previous psychiatric disorder requiring hospitalization 6. Inability to operate Palm OS® handheld device for self-reports 7. Inability to understand English 8. Inability to attend sessions at Stanford lab every 3 weeks 9. Pregnancy or planned pregnancy, or breastfeeding 10. Abnormal liver functioning tests
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: Low Dose Naltrexone|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self Reported Pain |  | duration of trial | 
| Self-reported fatigue |  | duration of trial | 
| Overall Fibromyalgia Symptom report |  | duration of trial |
Early Migration in a High Congruent Rotating Platform Total Knee Prosthesis Design

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to accurately assess the relationship between knee joint kinematics and migration of the tibial component of a high congruent, rotating platform total knee prosthesis by using fluoroscopy synchronised in time and space with a force plate, an external motion registration system and Electromyography (EMG).

Official Title
-----------------
Early Migration in a High Congruent Rotating Platform Total Knee Prosthesis Design. A Synchronised Motion Analysis Study With Fluoroscopy and RSA

Conditions
-----------------
Rheumatoid Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is diagnosed with osteoarthritis and requiring primary arthroplasty Patient is capable of giving informed consent and expressing a willingness to comply with this study Patient has no major deformities The ability to perform a lunge and step-up motion without the help of bars or a cane. No or slight pain during activity according to the Knee Society Pain Score (Ewald, 1989; Insall et al., 1989) Exclusion Criteria: The patient is unable or unwilling to sign the Informed Consent specific to this study The individual has a functional impairment of any other lower extremity joint besides the operated knee Patient has a flexion contracture of more than 15° Patient has a varus/valgus contracture of more than 15° Patients requiring revision arthroplasty The patient does not understand the Dutch or English language good enough to participate. The use of walking aids The inability to walk more than 500 meters
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 |
| --- | --- | --- |
| Migration | Roentgen stereophotogrammetric analysis is used to determine the migration of the prosthesis with respect to the bone. | 24 months post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anterior-posterior translation patterns | Fluoroscopy was used to determine the anterior-posterior translation patterns of the femoral component with respect to the tibial component. | 6 months post-operatively | 
| Axial rotation patterns | Fluoroscopy was used to determine the axial rotation patterns of both the insert and the femoral component with respect to the tibial component | 6 months post-operatively | 
| Muscle activity | Bipolar surface EMG data of the flexor and extensor muscles is collected. | 6 months post-operatively | 
| Shear forces | A force plate is used to measure the ground reaction forces which can be used to calculate the shear forces. | 6 months post-operatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Knee Joint, Arthroplasty, Replacement, Knee
Efficacy and Safety of Roflumilast in Japanese Patients With Bronchial Asthma (20 to 70 y) (APTA-2217-05)

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to investigate the effect of roflumilast (APTA-2217) on lung function in patients with asthma. Roflumilast will be administered orally once daily. The study duration consists of a baseline period (2 to 4 weeks) and a treatment period (24 weeks). The study will provide further data on safety, tolerability, and effectiveness of roflumilast.

Official Title
-----------------
A Confirmatory Study of APTA-2217 in Adult Patients With Bronchial Asthma (A Placebo-controlled Double-blind Comparative Study)

Conditions
-----------------
Bronchial Asthma

Intervention / Treatment
-----------------
* Drug: Roflumilast


Participation Criteria
=================
Eligibility Criteria
-----------------
Main inclusion criteria: Adult patients with bronchial asthma meeting the Guideline for Prevention and Control of Asthma 2003 (JGL 1998, revised 2nd edition) No change in asthma treatment during the last 4 weeks prior to the registration Non-smokers or ex-smokers for 12 months or more %FEV1 ranging between 60 and 80% Main exclusion criteria: Patients with poorly controlled asthma Inhalation therapy exceeding low dose during 4 weeks prior to the registration Concurrent respiratory diseases such as COPD considered to affect the efficacy evaluation

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

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

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: Roflumilast|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in lung function parameters. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pulmonary function test (spirometry), asthma symptoms, rescue medication, evaluation of QOL, asthma exacerbation, adverse events, pharmacokinetics. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma, Roflumilast, phosphodiesterase 4 inhibitor
RCT-evaluation of Retzius-sparing Robotic Prostatectomy

Study Overview
=================
Brief Summary
-----------------
Prospective randomized blinded RCT comparing Transdouglas Prostatectomy to classical transperitoneal anterior radical prostatectomy

Detailed Description
-----------------
We will evaluate functional urinary and sexual recovery, oncologic outcomes and postoperative complications in patients over a follow up period of 12 months

Official Title
-----------------
Robotic Retzius-sparing Radical Prostatectomy- a Randomized Controlled Trial Evaluating Transdouglas-RARP

Conditions
-----------------
Prostate Cancer, Urinary Incontinence

Intervention / Treatment
-----------------
* Procedure: robotic Prostatectomy (RARP)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Indication for radical prostatectomy >18 years old Literate Preoperatively continent informed signed consent for study Exclusion Criteria: cT4-Cancer Withdrawl of consent to study

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 |
| --- | --- |
| Other: Retzius-sparing RARP<br>Arm B randomizes men with an indication for radical robotic Prostatectomy (RARP) to retzius-sparing transdouglas RARP | Procedure: robotic Prostatectomy (RARP)<br>* Modification of robotic Prostatectomy Arm A classic technique/ anterior transperitoneal RARP Arm B Transdouglas Technique/retzius-sparing RARP<br>|
| Other: anterior transperitoneal RARP<br>Arm A randomizes men with an indication for radical robotic Prostatectomy (RARP) to anterior transperitoneal RARP | Procedure: robotic Prostatectomy (RARP)<br>* Modification of robotic Prostatectomy Arm A classic technique/ anterior transperitoneal RARP Arm B Transdouglas Technique/retzius-sparing RARP<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary continence | Pad use | 1 Week after Prostatectomy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resection margine |  | pathology report, approximately 1 week postoperatively | 
| Urinary continence | Pad use | 3, 6 and 12 months after Prostatectomy | 
| Postoperative complications |  | First 12 months after Prostatectomy | 
| postoperative PSA |  | 12 months |