linjc16/ctgov huggingface dataset:
Prevalence of Food Allergies to Proteins From Different Legumes

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to assess the prevalence of a sensitization to proteins from legumes by skin prick test using commercial extracts (peanut, soy, and pea) and raw material (lupin) in atopic and healthy subjects.

Official Title
-----------------
Prevalence of Food Allergies to Proteins From Different Legumes (Lupin, Peanut, Soy, and Pea) in Atopic and Healthy Subjects

Conditions
-----------------
Food Allergy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female subjects Age 18 up to 75 years For group Atopic: either documented allergy, neurodermatitis, allergic asthma, allergic rhinitis, and/or a positive atopic score based on the criteria of Erlangen (>10 points). Exclusion Criteria: Intake of antihistamines, tricyclic antidepressants, systemic corticosteroids Acute allergic symptoms Skin infections at the test side Pregnancy, lactation Acute inflammatory diseases

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Atopic<br>Subjects with either documented allergy, neurodermatitis, allergic asthma, allergic rhinitis, and/or a positive atopic score based on the criteria of Erlangen (>10 points). | |
| Non-atopic<br>Subjects without atopy. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of a sensitization to legume proteins | Evidence of a sensitization to one or more legume proteins (lupin, peanut, soy, and pea) | 20 minutes after skin prick | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lupin, peanut, soy, pea, legumes, cross-reactivity, sensitization, atopy
Health-Related Quality of Life in Gay Men With Localized Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Gathering information about prostate cancer, treatment, and quality of life from gay men with prostate cancer may help doctors plan the best treatment. PURPOSE: This clinical trial is collecting information about health-related quality of life from gay men with localized prostate cancer.

Detailed Description
-----------------
OBJECTIVES: To enroll 200 gay men with localized prostate cancer in a cross-sectional study of prostate cancer outcomes. To complete an R01 application using pilot data collected from these patients. To complete manuscripts describing the factors that influence quality of life and treatment satisfaction in these patients. OUTLINE: Patients complete a web-based survey about their disease (biopsy Gleason score, PSA at diagnosis, and T-stage), treatment (treatment type, time since treatment, and use of healthcare services [e.g., oral medications for erectile dysfunction]), symptom distress, and psychosocial factors (ethnicity, health literacy, level of social support, communication with provider, relationship status, and communication with partner) that affect their health-related quality of life. The data will be used to provide the information necessary to tailor an existing prostate cancer survivorship intervention to address the specific needs of gay men with prostate cancer.

Official Title
-----------------
Patient-Reported Outcomes For Gay Men With Localized Prostate Cancer

Conditions
-----------------
Prostate Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Diagnosis of localized prostate cancer No advanced disease Self-identified as gay PATIENT CHARACTERISTICS: Able to complete an online questionnaire Able to speak and understand English PRIOR CONCURRENT THERAPY: Not specified

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
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 disease factors and treatment factors on subjective well-being |  | Cross-sectional retrospective study, one timepoint | 
| Effect of disease factors and treatment factors on illness intrusiveness |  | Cross-sectional retrospective study, one timepoint | 
| Effect of psychosocial factors on subjective well-being |  | Cross-sectional retrospective study, one timepoint | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stage I prostate cancer, stage II prostate cancer
Regional Cerebral Hemodynamics Related to Global Hemodynamics

Study Overview
=================
Brief Summary
-----------------
This prospective investigation studies changes in regional cerebral hemodynamics and oxygenation as a function of cardiac output and blood pressure in intensive care patients.

Detailed Description
-----------------
Cerebral blood flow velocity (as an index of regional perfusion), dynamic cerebral autoregulation and regional cerebral oxygen saturation should be monitored if disturbances of cerebral perfusion and oxygenation have to be suspected. Noninvasive monitoring techniques are established. When detected early, disturbed perfusion and oxygenation may be treated promptly and permanent damage of brain tissue can be avoided. In critically ill patients, hemodynamic changes occur due to the disease itself but also as a function of diagnostic and therapeutic procedures. Systemic hemodynamic changes can be monitored using PiCCO® system (pulse contour cardiac output, Pulsion Medical Systems, Munich, Germany) that combines transpulmonal thermodilution and pulse contour analysis. PiCCO® continuously monitors cardiac output (CO), as well as static parameters like global enddiastolic blood volume index (GEDVI), and dynamic parameters as difference in pulse pressure (dPP) and stroke volume variation (SVV), respectively. CC Nexfin® (BMeye, Amsterdam, The Netherlands) is a noninvasive hemodynamic monitor. This study investigates the effects of changes in cardiac output on cerebral blood flow velocity and regional cerebral oxygen saturation in intensive care patients that underwent major abdominal surgery.

Official Title
-----------------
Impact of Systemic Hemodynamic Changes on Cerebral Perfusion and Oxygenation

Conditions
-----------------
Critically Ill Patients

Intervention / Treatment
-----------------
* Other: PLR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: critically ill mechanically ventilated needing advanced hemodynamic monitoring (PiCCO) Exclusion Criteria: <18years > 80years rhythm other than sinus

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: PLR|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cerebral blood flow velocity |  | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cerebral oxygen saturation |  | 1 hour |
Maternal Serum Alpha-fetoprotein Level May Predict the Presence of Morbid Adherent Placenta

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to compare between alpha-fetoproteine as a biological marker and between ultrasound and Doppler in prediction of morbid adherent placenta.

Detailed Description
-----------------
in pregnant women withe previous cesarean section, placenta previa and ultrasonographic finding of an abnormally adherent placenta dose maternal serum alpha-fetoprotein predict prenataly the presence of morbid adherent placenta accurately?

Official Title
-----------------
Alpha-fetoprotein as a Biochemical Marker in Prediction of Placenta Acreta Increta Percreta

Conditions
-----------------
Placenta Accreta

Intervention / Treatment
-----------------
* Diagnostic Test: Serum alpha-fetoproteine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant women with history of scarred uterus plcenta previa covering the scar of previous caesarean section as diagnosed by 2DU/S Gestational age from 28wks to full term Exclusion Criteria: pregnant women with fetus with congenital anomalies pregnant women with ovarian swelling pregnant women with medical disease

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 39 Years

Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Non_adherent plcenta<br>placenta separated within 15 minutes after delivery of fetus | |
| Adherent placenta<br>placenta dosenot separated within 15 minutes after delivery of fetus | Diagnostic Test: Serum alpha-fetoproteine<br>* Midtrimesteric serum alpha-fetoprotein mesurment with 2D US and 3D power Doppler with MS US scan .<br>* Other names: 3D power doppler with MS US;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal serum alpha-fetoprotein | ng/ml or MOM(Multiple of the median) | From 28weeks to 37 weeks |
Long Term Follow Up to Evaluate DTX301 in Adults With Late-Onset OTC Deficiency

Study Overview
=================
Brief Summary
-----------------
Determine the long-term safety of DTX301 following a single intravenous (IV) dose in adults with late-onset ornithine transcarbamylase (OTC) deficiency.

Detailed Description
-----------------
Study 301OTC02 is a long-term follow-up study to evaluate the safety and efficacy of adeno-associated virus (AAV) serotype 8 (AAV8)-mediated gene transfer of human OTC in adults with late-onset OTC deficiency. Only subjects who complete Study 301OTC01 (NCT02991144) are eligible to participate in Study 301OTC02.

Official Title
-----------------
A Long-Term Follow-up Study to Evaluate Safety and Efficacy of Adeno-Associated Virus (AAV) Serotype 8 (AAV8)-Mediated Gene Transfer of Human Ornithine Transcarbamylase (OTC) in Adults With Late-Onset OTC Deficiency

Conditions
-----------------
Ornithine Transcarbamylase (OTC) Deficiency

Intervention / Treatment
-----------------
* Other: No Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Completed the Week 52 visit in Study 301OTC01. Willing and able to provide written informed consent. Willing, able, and committed to comply with scheduled study site visits, study procedures, and requirements. Exclusion Criteria: Planned or current participation in another interventional clinical study that may confound the efficacy or safety evaluation of DTX301 during the duration of this study. Any clinically significant medical condition that, in the opinion of the investigator, would pose a risk to subject safety or would impede the 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 |
| --- |
|Other: No Intervention|No Intervention|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events and Serious Adverse Events |  | Up to 364 weeks following DTX301 administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Over Time in the Ureagenesis Rate | Sodium acetate is used as a tracer to measure the rate of ureagenesis | Baseline (average of Screening and Day 1) up to 364 weeks following DTX301 administration | 
| Change from Baseline Over Time in 24-Hour Area Under the Curve for Plasma Ammonia |  | Baseline (Day 0 of Study 301OTC01) up to 364 weeks following DTX301 administration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gene therapy, OTC Deficiency, Urea Cycle Disorder
Asunaprevir/Daclatasvir Safety Surveillance in Japanese Patients With Chronic Hepatitis C

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is: To evaluate the real-world safety, specifically the incidence rates of hepatic toxicity, pyrexia, and resistance, of DCV/ASV dual therapy in Japanese patients chronically infected with HCV GT-1.

Detailed Description
-----------------
Time Perspective: Other - For patients who are treated before the contract between Bristol-Myers Kabushiki Kaisha (BMKK) and the treating physician is initiated, patient data will be collected retrospectively after the contract is signed. Data will be collected prospectively for patients who initiate DCV/ASV treatment after the contract is initiated Patient Registry study - Yes; 48 weeks (Treatment: 24 weeks, Follow up: 24 weeks)

Official Title
-----------------
Asunaprevir/Daclatasvir Safety Surveillance in Japanese Patients With Chronic Hepatitis C

Conditions
-----------------
Chronic Hepatitis C

Participation Criteria
=================
Eligibility Criteria
-----------------
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Patients who are initiating DCV and ASV treatment for the first time under the approved indications, dosage, and administration will be included in this study

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| Treatment with DCV/ASV<br>Patients who are beginning to receive the treatment with DCV/ASV under the approved indications, dosage, and administration will be included in this study | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The real-world safety, specifically the incidence rates of hepatic toxicity, pyrexia, and resistance, of Daclatasvir/Asunaprevir (DCV/ASV) dual therapy in Japanese patients chronically infected with Hepatitis C virus Genotype 1 (HCV GT-1) |  | 28 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antiviral activity as determined by the proportion of patients with sustained virologic response at 24 weeks post-treatment Sustained virologic response at 24 weeks post-treatment (SVR24) |  | 48 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HCV
Integrated Navigation Services for Treatment Adherence, Counseling, and Research

Study Overview
=================
Brief Summary
-----------------
The goal of this research is to determine whether a Community Health Worker (CHW) intervention including a mobile telehealth (M-Health) component can help achieve long term viral suppression among Black people with poorly controlled HIV.

Official Title
-----------------
Integrated Navigation Services for Treatment Adherence, Counseling, and Research

Conditions
-----------------
HIV Infection Primary

Intervention / Treatment
-----------------
* Behavioral: INSTACARE


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages 18 years or older patient from adult HIV outpatient clinic at University of Miami/Jackson Memorial Health System self-identify as Black uncontrolled viral suppression as determined by treating clinician English speaking Exclusion Criteria: Any other condition(s) that the treating clinician determines would limit participant from meaningful study participation.

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: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: INSTACARE arm<br>Participants in this arm will receive the INSTACARE intervention for three months. | Behavioral: INSTACARE<br>* CHWs will provide participants with support via phone calls, home-visits, and accompaniment to clinic visits to improve medication management and HIV viral suppression. CHWs will contact participants at least once per week for three months.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Communication Preferences | Communication preferences will be reported as the number of participants who prefer any of the following intervention modes of administration: text messaging, phone calls, home visits, accompaniment to clinic visits, utilization of existing health portals and phone applications. Data will be collected via survey administered to participants by CHW. | 3 months | 
| Number of CHW contacts | CHW contacts with participants will be extracted from CHW tracking logs. | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV viral suppression, community health worker
Locking Compression Plate Fixation Versus Revision- Prosthesis of Vancouver-B2, B3 and C Periprosthetic Femoral Fractures After Total Hip Replacement

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to compare the clinical (range of motion, weight bearing, quality of life) and radiographic outcome (boney consolidation) between open reduction and internal fixation using locking compression plates with revision prosthesis using a non-cemented long femoral stem in a group of patients with a Vancouver type-B2, B3 and C periprosthetic fracture after primary total hip replacement.

Official Title
-----------------
Locking Compression Plate Fixation Versus Revision- Prosthesis of Vancouver-B2, B3 and C Periprosthetic Femoral Fractures After Total Hip Replacement

Conditions
-----------------
Periprosthetic Fractures

Intervention / Treatment
-----------------
* Procedure: Operation for Periprosthetic fractures of the hip with stem loosening


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Vancouver type- BlI, BIII and C fractures and unstable femoral prosthesis stem. Exclusion Criteria: Patients with pathological fractures, Vancouver type-A, Bl, and stable femoral prosthesis stem, Patients with hemi - prosthesis and periprosthetic femoral fractures were excluded from final analysis.

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 |
| --- | --- |
| Hyperion Prosthesis<br>Patients treated with the second generation long-stem revision prosthesis | Procedure: Operation for Periprosthetic fractures of the hip with stem loosening<br> <br> |
| Helios Prosthesis<br>Patients treated with the first generation long-stem revision prosthesis | Procedure: Operation for Periprosthetic fractures of the hip with stem loosening<br> <br> |
| Locking compression plate<br>Patients treated with LCP | Procedure: Operation for Periprosthetic fractures of the hip with stem loosening<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Outcome (Range of Motion of the hip) | Range of Motion of the hip | follow up of at least 1 year | 
| Radiographic Outcome (boney consolidation of the fracture) | boney consolidation of the fracture after 3 month, 6 month and at least 1 year after the operation | follow up of at least 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient's Mobility (assessed by the Parker's Mobility Score) | Patient's Mobility assessed by the Parker's Mobility Score | follow up of at least 1 year |
Obesity Intervention Obeldicks for Obese Children, Adolescents and Their Parents

Study Overview
=================
Brief Summary
-----------------
The intervention program Obeldicks was developed for obese children aged 6 to 16 years. This intervention is gender- and age specific. The 12-months intervention is based on nutrition course, behaviour therapy and exercise therapy. The evaluation compromised quality of structure, process and results of the intervention. Primary outcome measure is change of weight status as standard deviation score of BMI. Furthermore, cardiovascular risk factor profile, hormones (e.g. iGF-I, thyroid hormones, vitamin D status)adipocytokines, GI- hormones, intima media thickness are measured prior to and after the one-year intervention. The changes of these hormones and adipocytokines will allow to answer the questions whether the alterations of these hormones are a cause or consequence of overweight. Additionally, a genetic screening is performed to characterize the participants to probably predict response to intervention.

Official Title
-----------------
Evaluation of the Intervention Program Obeldicks for Obese Children and Adolescents

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Behavioral: obesity intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI> 97. percentile for age and gender Exclusion Criteria: Psychiatric disorders Endocrine disorders

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 18 Years

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: obesity intervention|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of BMI-SDS |  | 20 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of GI hormones |  | 10 years | 
| change of adipocytokines |  | 10 years | 
| change of cardiovascualr risk factors |  | 10 years | 
| change of metabolomics |  | 10 years | 
| change of psychological variables |  | 10 years |