linjc16/ctgov huggingface dataset:
Safety and Tolerability of Crofelemer for HIV-Associated Diarrhea

Study Overview
=================
Brief Summary
-----------------
This study is being conducted to evaluate the safety and tolerability of crofelemer 125 mg twice a day, taken orally, over 48 weeks of therapy in human immunodeficiency virus-positive (HIV+) subjects with diarrhea.

Official Title
-----------------
A Phase 3, Multicenter, Open-Label Evaluation of the Safety and Tolerability of Crofelemer in HIV-Positive Subjects With Diarrhea

Conditions
-----------------
HIV Enteropathy, Diarrhea With HIV

Intervention / Treatment
-----------------
* Drug: Crofelemer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female ≥ 18 years old History of HIV-1 infection On an antiretroviral therapeutic regimen for treatment of HIV-1 disease and associated conditions (including prophylactic antibiotics for Pneumocystis jirovecii or infection) for at least 4 weeks prior to screening Self-reported presence of diarrhea necessitating ADM use for at least 4 weeks Exclusion Criteria: CD4 counts < 100 cells/mm3 Oral temperature greater than 38.0° C, or unintentional weight loss of 5.0 kg or greater during the prior 2 months Bright red blood per rectum judged not to be of an anal (e.g., hemorrhoid, fissure) origin Immediate need for GI surgery or intervention for active GI bleeding, pancreatitis, peritonitis, intestinal obstruction, or intra-abdominal abscess

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: Crofelemer<br> | Drug: Crofelemer<br>* Crofelemer will be administered orally as 1 tablet(125 mg)BID for a total daily dose of 250mg crofelemer.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs). |  | 48 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV +, HIV positive, HIV associated diarrhea, AIDS, Diarrhea
Symptom Clusters in Children With Leukemia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the phenotypic and genotypic characteristics and their associations with symptom clusters experienced during treatment for childhood leukemia.

Detailed Description
-----------------
A repeated measures research design will evaluate phenotypic and genotypic treatment-related symptom associations experienced by children and adolescents 3-17 years of age with a diagnosis of leukemia.

Official Title
-----------------
Phenotypic and Genotypic Associations With Symptom Clusters During Childhood Leukemia Treatment

Conditions
-----------------
Childhood Leukemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Phenotypic and genotypic treatment-related symptom associations will be evaluated in children and adolescents 3-18 years of age with a diagnosis of leukemia. Exclusion Criteria: Children without a definite diagnosis of leukemia will be excluded. Children must be able to understand and answer the questions on the questionnaires. Children with have a cognitive impairment (e.g. Down syndrome) will not be able to complete the questionnaires and will not be eligible for the study.

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum 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 |
| --- | --- | --- |
Suprapatellar Nailing of Tibial Shaft Fractures

Study Overview
=================
Brief Summary
-----------------
To investigate the functional outcomes and prevalence and severity of knee pain for patients undergoing suprapatellar nailing of tibial shaft fractures.

Detailed Description
-----------------
Suprapatellar nailing... Participants will be followed for 10 years prospectively. Follow up visits will occur at 2 weeks, 6weeks, 3 months, 6 months, 12 months, 3 years, 5 years, 7 years and 10 years. Interim analysis will be done at 1, 3, 5, and 7 years with final analysis occuring at 10 years. Primary and secondary endpoints in patients undergoing suprapatellar nailing of tibial shaft fractures are: To evaluate the long term presence of knee pain To evaluate the long term functional outcomes

Official Title
-----------------
Suprapatellar Nailing of Tibial Shaft Fractures: Long Term Follow Up

Conditions
-----------------
Broken Leg

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Isolated, unilateral tibial shaft fractures Orthopaedic Trauma Association (OTA) classification of 42 and may extend to 43A or 43B age 18-65, including pregnant women open or closed fractures able to sign consent english speaking Exclusion Criteria: compartment syndrome other lower extremity injuries that will affect functional outcomes problems maintaining follow up (homeless, not willing to return for follow up) pathological fractures prisoners previous retained hardware in the injured leg injuries requiring vascular repair

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long term presence of knee pain | During follow up visits participants will be administered the Visual Analog Scale (VAS) and the Patient Reported Outcomes Measurement Information System (PROMIS) Pain intensity short form 3a and Pain interference short form 8a. These forms will be analyzed together to determine an overall presence of knee pain. | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long term functional outcomes | During follow up visits participants will be administered the Lysholm knee score and the PROMIS Mobility measure. These forms will be analyzed together to determine the overall long term function of the participants. | 10 years | 
| Knee Range of Motion (ROM) | During follow up visits the participants knee ROM will be measured | 10 years | 
| Fracture Healing | During follow up visits fracture healing will be evaluated | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tibial shaft fractures
Family Study of Congenital Cardiovascular Malformations

Study Overview
=================
Brief Summary
-----------------
To determine genetic mechanisms responsible for congenital cardiovascular malformations.

Detailed Description
-----------------
BACKGROUND: Congenital cardiovascular malformations are a major cause of infant mortality in the United States. In 1985, six defects -- hypoplastic left heart, tetralogy of Fallot, truncus arteriosus, transposition of the great arteries, endocardial cushion defect, and ventricular septal defect -- were among the fifteen most frequent causes of premature death due to congenital malformations, accounting for 109,063 years of life lost. This loss of productive life continues in spite of major advances in medical and surgical treatment of congenital cardiovascular malformations. Even as successful treatment modalities are developed, the survival to reproductive years without improved understanding of genetic risks produces additional unanswered questions. DESIGN NARRATIVE: Clinical assessment of cases and controls included medical history, pedigree construction, complete evaluation by a pediatric cardiologist, and two-dimensional and Doppler echocardiography. First degree relatives of cases and controls underwent clinical-echocardiographic evaluation also. The distribution of cardiac defects for all pedigrees within and among the proband group was delineated. The frequencies of heart defects were compared within and among pedigrees of cases and controls. Regressive logistic models of genetic determinants for the malformations were tested. The three participating clinical centers included University of Maryland at Baltimore, the Johns Hopkins Hospital, and the University of Rochester in Rochester, New York. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Cardiovascular Diseases, Defect, Congenital Heart, Heart Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

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

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 |
| --- | --- | --- |
Effect of Long Chain Polyunsaturated Fatty Acids on Behavior and Cognition in Children With Attention Deficit Hyperactivity Disorder

Study Overview
=================
Brief Summary
-----------------
The study investigates whether eicosapentaenoic/docosahexaenoic acid supplementation affects behavior and cognition in children with attention deficit hyperactivity disorder.

Official Title
-----------------
Effect of Supplementation With Long Chain Polyunsaturated Fatty Acids on Behavior and Cognition in Children With Attention Deficit Hyperactivity Disorder

Conditions
-----------------
Attention Deficit Hyperactivity Disorder

Intervention / Treatment
-----------------
* Dietary Supplement: Omega-3 fatty acids


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ADHD diagnosis Age 9-12y Native German speaker Exclusion Criteria: Allergy against fish and fish products IQ below 85 Objections against pork gelatine

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 12 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Omega-3 fatty acids<br> | Dietary Supplement: Omega-3 fatty acids<br>* duration: 4 month<br>|
| Placebo Comparator: Olive oil<br> | Dietary Supplement: Omega-3 fatty acids<br>* duration: 4 month<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Behavior, Cognition |  | Before intervention and 16 weeks after start of intervention |
Study to Assess Change in Disease Activity and Adverse Events of RINVOQ in Adult Participants With Ankylosing Spondylitis in the Real-World Japan

Study Overview
=================
Brief Summary
-----------------
Axial spondyloarthritis (axSpA), which encompasses radiographic axSpA (r-axSpA, also known as ankylosing spondylitis [AS]) is an immune-mediated inflammatory disease primarily affecting the axial skeleton. This study will assess how effective Rinvoq is in treating axSpA. Rinvoq is an approved drug for treating axSpA. Approximately 100 adult participants who are prescribed Rinvoq by their physician in accordance with local label will be enrolled in Japan. Participants will receive Rinvoq as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 52 weeks. There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.

Official Title
-----------------
A Study to Evaluate Safety and Effectiveness of RINVOQ in Adult Participants With Ankylosing Spondylitis in the Real-World Japan (SELECT AXIS RW)

Conditions
-----------------
Ankylosing Spondylitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant with clinical diagnosis of ankylosing spondylitis (AS) and meeting the modified New York Criteria for AS. Participant who is administered the first dose of Rinvoq for AS. Exclusion Criteria: Participant with prior treatment by JAK inhibitors. Participant currently participating in another clinical study except non-interventional study. Participant for whom upadacitinib is contraindicated. Participants who are not registered within 14 days after initiation of Rinvoq treatment for AS.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Rinvoq<br>Participants will receive Rinvoq as prescribed by their physician according to local label. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence Percentage of Serious Infection as Adverse Drug Reactions ( ADR) | Incidence of serious drug related adverse reactions will be assessed. | Up to 52 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ankylosing Spondylitis, RINVOQ
Gender Disparity in Burn Injury Survival

Study Overview
=================
Brief Summary
-----------------
Hypothesis 1: A quantifiable difference in inflammatory cytokines exist in women with burn injury and this correlates with clinical markers of outcome Hypothesis 2: The amount of adipose tissue contributes to the severity of cellular immune response (CMI) dysregulation in response to burn injury Skin-fold caliper measurements will be taken on consented patients (both male and female) to determine body fat percentage. Serum samples will be obtained from these patients. The level of inflammatory cytokines in the serum will be measured to determine if there is a link between body fat percentage, pro-inflammatory cytokines and the ability of women to survive burn injury.

Detailed Description
-----------------
Consented patients admitted to University Medical Center with greater than 15% total body surface area burns will participate in this study. A skin-fold caliper measurement will be performed to determine body fat percentage. Serum samples will be obtained and assayed for inflammatory cytokines to establish whether or not a link between obesity in women and pro-inflammatory cytokines exists. If so, obesity may be a factor which contributes to the gender disparity in burn wound survival.

Official Title
-----------------
Gender Disparity in Burn Injury Survival

Conditions
-----------------
Obesity, Burn Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women ages 18 to 65 years Admitted to University Medical Center with greater than 15% total body surface area burns Able to provide informed consent or has authorized representative to give informed consent Exclusion Criteria: Prisoners or pregnant women Individuals with injuries that preclude taking caliper measurements

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 |
| --- | --- |
| Women with burn injury<br> | |
| Men with burn injury<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory cytokine levels | We will measure inflammatory cytokine levels and determine if elevated cytokine levels are linked to obesity and ultimately burn injury survival | 72 hours post admission until patient discharge | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
outcome
SFDI in High Energy Lower Extremity Fracture

Study Overview
=================
Brief Summary
-----------------
This is a non-randomized prospective study of 20 patients with high energy lower extremity fractures evaluating feasibility and acceptability of SFDI, a real-time optical imaging technology.

Official Title
-----------------
Spatial Frequency Domain Imaging-based Perfusion Imaging to Assess Soft Tissue Injury in High Energy Lower Extremity Fracture

Conditions
-----------------
Trauma Injury

Intervention / Treatment
-----------------
* Procedure: Lower Extremity Surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 years or older High energy lower extremity fracture Provision of informed consent Exclusion Criteria: Upper extremity fracture Metatarsal fractures

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lower extremity fracture<br>High energy lower extremity fractures | Procedure: Lower Extremity Surgery<br>* Patients 18 years of age or older with high energy lower extremity fractures. Provision of informed consent.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility and acceptability of the SFDI Imaging | The long-term objective for this research is to determine whether objective measures of perfusion through SFDI can be a predictive tool used in the ED, clinic or the operating room to determining when high-energy lower extremity fractures can safely undergo surgical fixation. | 4 minutes or less | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Trauma, Orthopaedic, Lower Extremity
Restoration of Cutaneous Sensorum in Patients With Diabetic Peripheral Neuropathy (DPN) Via Metanx®

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to determine if Metanx improves sensory neuropathy in persons with Type 2 diabetes. Metanx is a medical food available with a prescription from a physician. It consists of L-methylfolate, Pyridoxal 5'-phosphate, and Methylcobalamin, which are the active forms of folate, vitamin B6, and vitamin B12, respectively. Subjects will be assigned to receive Metanx for 12 months. Baseline quantitative sensory testing will be done before the patient receives Metanx. Additional quantitative sensory testing will be done at 6 and 12 months to evaluate.

Official Title
-----------------
Restoration of Cutaneous Sensorum in Patients With Diabetic Peripheral Neuropathy (DPN) Via Metanx®

Conditions
-----------------
Diabetic Peripheral Neuropathy

Intervention / Treatment
-----------------
* Other: Metanx® (Oral L-methylfolate, Methylcobalamin and Pyridoxal 5'-phosphate)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Consecutive diabetic patients entering the office (private practice) Subjective symptoms of numbness, burning, paresthesia, etc. Failed Monofilament of at least two points on each foot Abnormal PSSD study Willing to participate in protocols or study Taking one Metanx tablet bid for 2 weeks then one Metanx tablet daily Keep scheduled appointments for follow up studies Report any other medical interventions, studies, or medication changes Report any problems of medical or psycho-social matters to investigators HgbA1c NOT monitored or specific value required for participation Exclusion Criteria: History of back problems (Surgery or ECSI) or other large fiber neuropathies History of chemotherapy History of chemical exposure
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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metanx<br>Metanx bid for 2 weeks then daily. Compare to non treated patient population | Other: Metanx® (Oral L-methylfolate, Methylcobalamin and Pyridoxal 5'-phosphate)<br>* One pill twice a day for 2 weeks. Then one pill a day until 12 month study is up.<br>* Other names: Metanx;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Epidermal Nerve Density Count | Measure increase or decrease in ENFD count after 12 months of Metanx therapy in patients with diabetic peripheral neuropathy | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DPN