linjc16/ctgov huggingface dataset:
International, Multicentric, Observational Study to Characterize Subpopulations of Patients With Autism Spectrum Disorder

Study Overview
=================
Brief Summary
-----------------
To determine sufficient number of biological and clinical markers to identify subgroups of potential best responders to a specific medication

Official Title
-----------------
International, Multicentric, Observational Study to Characterize Subpopulations of Patients With Autism Spectrum Disorder

Conditions
-----------------
Autism Spectrum Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants previously diagnosed with ASD (DSM-5) Available well-documented health records within the first 2 years of life Participants must have a parent or reliable caregiver who agrees to provide information about the participant Participants willing and consenting or assenting to participate. Exclusion Criteria: Episode of fever (i.e. ≥100.5 °F or ≥ 38 °C) or clinically significant illness without fever (as judged by the investigator), within 10 days before any study assessment. If the investigator assesses any unwillingness or any medical condition that may prevent the subject from completing this study.

Ages Eligible for Study
-----------------
Minimum Age: 12 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 |
| --- | --- | --- |
| Clinical characterisation of the ASD-Phen1 and ASD-Phen2 subpopulations. | A semi-structured medical questionnaire will be administered to collect clinical (sign and symptoms) and anthropomorphic features. | Day 0 | 
| Molecular characterization of the ASD-Phen1 and ASD-Phen2 subpopulations | Better characterize subpopulations of ASD subjects and potentially identify/confirm a molecular signature specific of each subpopulation. | Day 0 |
Real-world Study of UTD1 in Chinese Advanced Breast Cancer

Study Overview
=================
Brief Summary
-----------------
To evaluate the efficacy and safety of UTD1 in patients with advanced breast cancer.

Official Title
-----------------
An Observational, Real-world Study Study of UTD1 in Chinese Advanced Breast Cancer

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged over 18 years old. Metastatic breast cancer included unresectable locally advanced breast cancer, de novo stage IV breast cancer, and recurrent metastatic breast cancer. Plan to receive or has received UTD1 monotherapy or UTD1 based therapy Available medical history. Exclusion Criteria: 1.Incomplete medical history.

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| UTD1<br>UTD1 monotherapy or UTD1 based therapy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | Progression free survival | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Number of participants with treatment-related adverse events as assessed by CTCAE v 5.0 | 6 weeks |
CGM Evaluation of Glucose Excursions in Basal Insulin Treated T2DM at Fasting Glucose Target

Study Overview
=================
Brief Summary
-----------------
This is a trial to determine if patients who are well controlled and on basal insulin are treated with excessive basal dose.

Detailed Description
-----------------
In many clinical trials, basal insulin is titrated to only a fasting glucose goal. The usual final dose is >0.4U/kg. In carefully CGM monitored/titrated studies in both basal insulin alone or in pump-treated T2DM, we have found the basal insulin dose to be <0.3U/kg. This suggests that if guided by a single daily fasting glucose, titration may result in an excessive basal dose. This study will examine that issue.

Official Title
-----------------
CGM Evaluation of Glucose Excursions in Basal Insulin Treated T2DM at Fasting Glucose Target

Conditions
-----------------
Type 2 Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes Age 18 years and above Concurrently on +/-thiazolidnedione +/-DDP IV inhibitors +/-metformin +/- glinides and basal insulin analogs A1C 10% or below Capable of self monitoring glucose at least 4 x a day Previously compliant with clinical recommendations Fasting blood glucose <110mg/dl average for 3 consecutive days BMI <45 kg/m Exclusion Criteria: Urinary ketosis Current or expected alternation in insulin sensitivity such as major surgery, infection, renal failure, glucocorticoid treatment, recent serious hypoglycaemic episode Currently participating in another clinical trial Using rapid insulin insulin Pregnancy or nursing or the intention of becoming pregnant or not using adequate birth control Significant liver or heart failure.

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 |
| --- | --- | --- |
| Percentage of time CGM glucose is <70mg/dl | The percentage of time CGM glucose is <70 mg/dl during the basal glucose evaluation | the subject will be followed for 9 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of time CGM glucose is <40 mg/dl | The percentage of time the CGM glucose is <40 mg/dl | the subject will be followed for 9 days | 
| Determined hypoglycaemic episodes | The percentage of subjects who perceived all CGM determined hypoglycaemic episodes | the subject will be followed for 9 days | 
| Weight gain | The mean weight gain since initiating basal insulin fromo retrospectively gathered data. | the subject will be followed for 9 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
type 2 diabetes, continuous glucose, basal insulin
Prostate Stimulation for Sexual Dysfunction

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to use a device to stimulate the prostate with a goal of helping improve symptoms in men with sexual dysfunction.

Detailed Description
-----------------
The purpose of the study is to use a device to stimulate the prostate. The goal of this is to help men with sexual dysfunction. Sexual dysfunction can include conditions like delayed ejaculation (e.g.takes more than 21 minutes to climax) and can hopefully assist them in achieving faster time to ejaculation (e.g. closer to the median of 5.4 minutes in a normal individual) along with erectile dysfunction (e.g. the inability to achieve and sustain an erection).

Official Title
-----------------
Prostate Stimulation for Sexual Dysfunction

Conditions
-----------------
Sexual Dysfunction, Erectile Dysfunction, Delayed Ejaculation, Anorgasmia

Intervention / Treatment
-----------------
* Device: Prostate stimulator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males >18 years of age suffering from sexual dysfunction Exclusion Criteria: Individuals who have had a prostatectomy - removal of prostate Inability to operate the device for any reason Females Males <18 years of age

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prostate stimulation device arm<br>Participants will be asked to use our prostate stimulation device. | Device: Prostate stimulator<br>* Prostate stimulation device for sexual dysfunction<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in modified International Index of Erectile Dysfunction score | score 0 to 30 with higher score meaning better erectile function | baseline and up to 1 month post-baseline |
Genetics of Polycystic Ovary Syndrome

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to look at genes (DNA) and how they affect health and disease. Genes are the instruction manual for the body. The genes you get from your parents decide what you look like and how your body behaves. They can also tell us a person's risk for certain diseases and how they will respond to treatment. We will collect a saliva sample for genetic research.

Detailed Description
-----------------
Polycystic ovary syndrome (PCOS) is a common endocrine disorder of women, characterized by elevated levels of male hormones, absent menstruation, infrequent or very light menstruation, and reduced ability to reproduce. Genetic factors likely contribute to the etiology of PCOS, but no genes have been identified with certainty. The findings from these studies will enhance our understanding of the genetics of PCOS, a major contributor to female infertility. Better knowledge of PCOS genes will also help in predicting responses to treatments for infertility, insulin resistance, and other aspects of the disease. Women with PCOS may be eligible to participate in this study if they are between the ages of 18 and 50 and have two living biological parents who are also willing to participate. Study participation involves telephone screening and consent and home collection by subjects (probands) and their parents of sputum (saliva) in a provided container. Specimen containers and signed consent forms will be returned to the study site by mail. The major goal of this research project, the identification of genes contributing to PCOS, will provide basic understanding of the genotype-phenotype relationships that contribute to features of PCOS. Knowledge of PCOS genes would assist physicians in predicting and assessing responses to interventions that promote fertility, improve insulin sensitivity, and treat other aspects of the disease.

Official Title
-----------------
Population Genetics of Polycystic Ovary Syndrome

Conditions
-----------------
PCOS

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of PCOS Both biological parents alive Yes to both answers and parents willing to participate Exclusion Criteria: Healthy women
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Women with diagnosis of PCOS | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PCOS gene identification. |  | December 2010 |
Comparing Calories at Fast Food Restaurants

Study Overview
=================
Brief Summary
-----------------
Rating systems are intended to guide consumer choices. This project will determine if a previously developed scale that evaluates the healthiness of a restaurant is correlated with the actual choices consumers make when they patronize the restaurants. The study will also assess whether a restaurant marketed as healthy (Subway) rates higher on this scale than another restaurant that makes no such claims (McDonald's). Finally, the investigators will compare the calorie purchases from these two restaurants among youths and their families who eat at each of the restaurants.

Official Title
-----------------
Rating Fast Food on Healthiness

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

Intervention / Treatment
-----------------
* Behavioral: Fast Food Restaurant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 12-21 Year Olds that live in local area Like to eat at Subway and McDonald's

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 21 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 |
| --- | --- |
| Adolescents<br>Participants 12-21 years old. | Behavioral: Fast Food Restaurant<br>* Participants will purchase a meal at Subway and McDonald's, on different days.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Calories Consumed at each Restaurant | Using purchase receipts and point-of-purchase surveys, we determine how many calories each participant purchases. | Calories will be recorded at two time points within 1-2 weeks |
Dose-finding Study of ASP2151 in Subjects With Herpes Zoster

Study Overview
=================
Brief Summary
-----------------
To investigate the efficacy and safety of three different doses of ASP2151, as compared to valacyclovir hydrochloride in subjects with herpes zoster, and to determine the recommended clinical dose.

Official Title
-----------------
Dose-finding Study of ASP2151 in Subjects With Herpes Zoster- A Multicenter, Randomized, Double-blind, Valacyclovir Hydrochloride-controlled, Parallel-group, Comparative Study

Conditions
-----------------
Herpes Zoster

Intervention / Treatment
-----------------
* Drug: ASP2151
* Drug: Valacyclovir hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects aged from 20 years to under 80 years on the day informed consent is obtained Subjects to whom the study drugs can be orally administered within 72 hours after the onset of rash due to herpes zoster Subjects in whom protocol-specified observations and assessments are considered possible Exclusion Criteria: Subjects with extremely compromised immune function due to underlying diseases, treatment with Immunosuppressive agents etc., or radiotherapy Subjects with a serious underlying disease that corresponds to Grade 3 in the Classification Criteria for teh Seriousness of Adverse Drug Reactions Subjects with concurrent malignant tumors, or those with a history of malignant tumors within the past 5 years

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 79 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>ASP2151 low dose | Drug: ASP2151<br>* oral<br>|
| Experimental: 2<br>ASP2151 middle dose | Drug: ASP2151<br>* oral<br>|
| Experimental: 3<br>ASP2151 high dose | Drug: ASP2151<br>* oral<br>|
| Active Comparator: 4<br>Valacyclovir hydrochloride | Drug: Valacyclovir hydrochloride<br>* oral<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the efficacy and safety of ASP2151 with valacyclovir in subjects with Herpes Zoster |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of cutaneous symptoms and pain |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Valacyclovir hydrochloride, herpes zoster, ASP2151
Surgery in Context of Terrorist Attack : a Survey of French Surgeons

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to assess the surgical knowledge of French Surgeons in cas of Terrorist Attack.

Detailed Description
-----------------
Survey was sent by email to French Surgeons affiliated to French Association of General Surgeons. First series of questions are relative to age, qualification, usual surgical practice, in order to define different surgical profiles. Second series of questions are relative to knowledge in the field of knowledge about trauma and massive casualties surgery. Third series of questions are relative to the feeling of easiness in case of various situations involving severe trauma and massive casualties. Results are analyzed in order to assess the need for learning and training in the field of trauma and massive casualties surgery.

Official Title
-----------------
Surgery in Context of Terrorist Attack : Report of the 121st Annual Congress of French Association of Surgery

Conditions
-----------------
Trauma Injury, War Injury, Surgical Procedure, Unspecified

Intervention / Treatment
-----------------
* Behavioral: evaluation of the need for training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: French Licensed and Resident Surgeons Exclusion Criteria: Medical Doctor, not Resident
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: evaluation of the need for training|analyse of results of survey|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assessing the knowledge and the skills of general surgeons in the field of trauma surgery |  | 5 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
need for surgical training, surgery and terrorist attack
Post-Marketing Surveillance of Ventavis® in Chinese Patients With Primary Pulmonary Hypertension (PPH)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate the safety and efficacy of inhaled Iloprost (Ventavis®) among adult Chinese patients with primary pulmonary hypertension, which is in compliance with Chinese SFDA regulation.

Official Title
-----------------
Post-Marketing Surveillance of Ventavis® in Chinese Patients With Primary Pulmonary Hypertension (PPH)

Conditions
-----------------
Primary Hypertension

Intervention / Treatment
-----------------
* Drug: Ventavis (Iloprost, BAYQ6256)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Both male and female age 18-65 years old The treating physician has chosen Ventavis as a suitable long-term treatment for the patient Patient with Primary Pulmonary Hypertension (i.e. IPAH or FPAH) and classified as NYHA functional class III Written informed/data protection consent No prior treatment with Ventavis or other active treatments for PPH within 6 weeks of date of study. Exclusion Criteria: Known or newly identified contraindication for administration of Ventavis as stated in the Ventavis product package insert.

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 |
| --- | --- |
| Group 1<br> | Drug: Ventavis (Iloprost, BAYQ6256)<br>* Iloprost solution for inhalation, BAYQ6256, Synthetic Prostacyclin analog<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of Adverse Events |  | At week 4,12 and 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 minute walking test (6-MWT) |  | At week 4,12 and 24 | 
| NYHA functional class |  | At week 4,12 and 24 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Primary Pulmonary Hypertension (PPH)
Severe Complications After Gastrectomy for Esophagogastric Junction and Gastric Cancer

Study Overview
=================
Brief Summary
-----------------
Gastrectomy is the main treatment for gastric and Siewert type II-III esophagogastric junction (EGJ) cancer. This surgery is associated with significant morbidity. The aim of the present study is to identify the predictors of postoperative morbidity and to evaluate long term survival according to complications. This is a retrospective cohort study.

Detailed Description
-----------------
Gastrectomy is the main treatment for gastric and Siewert type II-III esophagogastric junction (EGJ) cancer. This surgery is associated with significant morbidity. The aim of the present study is to identify the predictors of postoperative morbidity and to evaluate long term survival according to complications. This was a retrospective cohort study. The investigators included patients treated with gastrectomy for gastric or EGJ cancers at a single center. Severe morbidity was defined as Clavien-Dindo score ≥3. The following factors are analyzed: age, sex, comorbidity, American Society of Anesthesiologists (ASA) physical status, tobacco and alcohol consumption, body mass index (BMI), hematocrit, serum albumin level, tumor location, the use of preoperative chemotherapy, laparoscopic or open surgery, total or subtotal gastrectomy, duodenal stump closure, multi-organ resection, lymphadenectomy, reconstruction method, T status, lymph node metastasis, and resection margin. The T stage was grouped by T1-T2 and T3-T4 for analysis. Patients will be followed for 5 years after surgery for survival analysis. A multivariate analysis is performed to identify predictors of overall and severe morbidity; and predictors of long-term survival.

Official Title
-----------------
Severe Complications After Gastrectomy for Esophagogastric Junction and Gastric Cancer: Perioperative Results and Long Term Survival

Conditions
-----------------
Gastric Cancer, Esophagogastric Junction Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients treated with a gastrectomy for gastric cancer or esophagogastric cancer. Confirmed adenocarcinoma histology. Exclusion Criteria: Histology different from adenocarcinoma.

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with severe 30-day or in-hospital morbidity | Clavien 3 or higher complications | Perioperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median and percentage of patients with long-term survival | 5 year survival | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stomach neoplasms, gastrectomy, Risk factors, morbidity, adenocarcinoma