linjc16/ctgov huggingface dataset:
Phase 1 Study of TG01 and Erlotinib in Non-small Cell Lung Cancer (NCSLC) Patients

Study Overview
=================
Brief Summary
-----------------
This is a multicenter, open-label, phase 1, dose escalation study. The purpose is to determine the highest dose of TG01 that can be safely given to patients with Non-Small Cell Lung Cancer in combination with erlotinib.

Official Title
-----------------
A Phase 1 Dose-Escalation Pharmacokinetic and Pharmacodynamic Study of TG01 Tablets in Combination With Erlotinib in Non-Small Cell Lung Cancer Patients

Conditions
-----------------
Non-small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: TG01


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria (include but are not limited to): Histogically or pathologically determined relapsed/recurrent Stage IIIb (plueral effusion) or IV NSCLC. Measurable or evaluable disease as defined by RECIST Must have failed at least one prior chemotherapy regimen or have refused chemotherapy. ECOG perfromance status of 0,1, or 2. Exclusion Criteria (include but are not limited to): Radiation therapy (excluding CNS therapy) < 2 weeks, chemotherapy, non-cytotoxic investigational agents or high dose corticosteroids within 3 weeks of intitating therpy or patients who have not recovered from adverse effects due to agents administered more than 3 weeks earlier. Evidence of New York Heart Associatation Class III or greater cardiac disease. History of myocardial infarction, stroke, or cardiovascular intervention within the last 12 months. Patients on anti-platlet drugs or anticoagulants such as Placix and Coumadin. Systemic central nervous system metastases. The patient must be stable after radiotherapy for >/= to 2 weeks and off corticosteroids for >/= to 1 week. Pregnant or nursing women. Patients who are primarily refactory to erlotinib.

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

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br> | Drug: TG01<br>* Drug:TG01tablets given orally QD Drug: erlotinib tablets 150mg QD<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Saftey, maximum tolerated dose, optimal biological dose and pharmacokinetics. |  | Baseline, 8, 15 and 28 days |
Preload, Weight Management, Risk of Cardiovascular Disease

Study Overview
=================
Brief Summary
-----------------
Investigators presumed that preload consumers will have more weight reduction and lower risk of cardiovascular disease

Detailed Description
-----------------
To our knowledge, all previous studies evaluated the energy intake in a dietary meal after consuming a low-energy-dense preload while none assessed the sustainability of lower amount of energy intake and body weight changes in a long-term. On the other hand, the sustainability of lower energy intake in a long term might be affected by higher dietary diversity score due to considering preload in diets. Notably, increased diet variety is associated with higher overall dietary energy intake and weight gain.

Official Title
-----------------
Effect of Preload on Body Weight and Cardiovascular Risks

Conditions
-----------------
Body Weight

Intervention / Treatment
-----------------
* Other: preload diet
* Other: control diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI > 25, older than 18 years Exclusion Criteria: poor dietary compliance

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: preload<br>subjects in preload group consumed salad, yogurt and water 15 minutes before the main meal. | Other: preload diet<br>* All participants were prescribed a calorie-restricted diet (-200 to -500 kcal/d). Calorie requirements of each subject were estimated based on resting energy expenditure (REE) by using Harris- Benedict equation and also considering the physical activity levels. The diets were constructed to provide similar proportions of carbohydrates (55% energy), protein (15% energy) and total fat (30% energy).<br>|
| Experimental: control<br>subjects in control group consumed salad and yogurt with meal. | Other: control diet<br>* All participants were prescribed a calorie-restricted diet (-200 to -500 kcal/d). Calorie requirements of each subject were estimated based on resting energy expenditure (REE) by using Harris- Benedict equation and also considering the physical activity levels. The diets were constructed to provide similar proportions of carbohydrates (55% energy), protein (15% energy) and total fat (30% energy).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the amount of weight reduction in two dietary groups |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
preload, anthropometric measures, cardiovascular risk factors
Study Evaluating PPM-204 In Subjects With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to learn whether PPM-204 has an effect on lowering blood glucose (blood sugar) levels and is safe in treating people with type 2 diabetes.

Detailed Description
-----------------
The objectives of the study are to identify doses of PPM-204 that are therapeutically effective and well tolerated in improving glycemic control over 24 weeks of treatment in subjects with type 2 diabetes mellitus (T2DM).

Official Title
-----------------
A 24-Week, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Of The Safety And Efficacy Of PPM-204 In Subjects With Type 2 Diabetes

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: PPM-204


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women of non-childbearing potential, 18 to 70 years old Subjects currently treated with diet and exercise alone and subjects receiving a single oral antidiabetic medication BMI > 23 and < 43 For subjects currently treated with 1 antidiabetic medication: HbA1c is greater than or equal to 6.8% and less than or equal to 8.5%. For subjects not currently treated with antidiabetic medications: HbA1c is greater than or equal to 7.2% and less than or equal to 9.0% Exclusion Criteria: Subjects requiring insulin therapy Subjects currently receiving 2 or more oral antidiabetic medications Subjects requiring systemic corticosteroids, unless treatment was discontinued at least 4 weeks before the screening visit Subjects receiving warfarin Subjects currently receiving thiazolidinediones, unless treatment was discontinued 8 weeks before the screening visit Significant diabetic complications (retinopathy, nephropathy, symptomatic neuropathy)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: PPM-204|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting Plasma Glucose |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean changes of HbA1c, Fasting Insulin, HOMA-IR and QUICKI indices, Body weight, waist measurements, total cholesterol, LDL-C, HDL-C, total/HDL, apolipoprotein A-1 & B, triglycerides, free fatty acids, hs C-reactive protein, adiponectin, edema. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 Diabetes, Diabetes
Proton Pump Inhibitor (PPI) Inappropriate Use and Economic Burden in Chinese Population

Study Overview
=================
Brief Summary
-----------------
This is a descriptive retrospective database analysis study in using database. All patients with a physician PPI prescription will be selected to estimate the PPI inappropriate use.

Detailed Description
-----------------
Study primary objective is to identify the inappropriate use of PPI (overall, outpatient & inpatient).

Official Title
-----------------
Proton Pump Inhibitor (PPI) Inappropriate Use and Economic Burden in Chinese Population: A Descriptive Retrospective Observational Study Using Database

Conditions
-----------------
Gastrointestinal Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients in 2015 China Health Insurance Research Association (CHIRA) database. Patients had PPI prescription during Jan. 2015 to Dec. 2015 will be selected to estimate the PPI inappropriate use. Exclusion Criteria: • Patients without data of treatment information.
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 |
| --- | --- | --- |
| Overall proportion of patient inappropriate use of PPI | Overall number of patient times/courses with PPI inappropriate use (including non-indication use, over maximum daily dose and over maximum duration) divided by the total number of patient-times/courses with PPI use for both outpatients and inpatients. | 2015.01-2015.12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stress Ulcer Prevention
Post Mortem Tissue Donation of Pediatric Tumor Tissues and Cells

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to utilize all donated pediatric tumor tissues and cells obtained from autopsy to prospectively develop novel patient derived orthotopic xenograft (PDOX) mouse models as well as in vitro cell culture model systems for pediatric cancers, and also provide tissue samples to other researchers and organizations (eg, CBTN, DIPG Registry, COG).

Detailed Description
-----------------
The objective of this study is to utilize all donated pediatric tumor tissues and cells obtained from autopsy to prospectively develop novel patient derived orthotopic xenograft (PDOX) mouse models as well as in vitro cell culture model systems for pediatric cancers, and also provide tissue samples to other researchers and organizations (eg, CBTN, DIPG Registry, COG). This model system will then be subjected to 1) comprehensive histopathological and molecular characterizations during serial in vivo sub-transplantations; 2) cryopreserved for long term preservation of tumorigenicity; and 3) used for future biological studies and preclinical drug testing.

Official Title
-----------------
Post Mortem Tissue Donation of Pediatric Tumor Tissues and Cells

Conditions
-----------------
Pediatric Cancer

Intervention / Treatment
-----------------
* Other: Collection of post mortem tissue donation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pediatric patients with cancer and non-cancer tumor types (solid, liquid, neuro-oncology) Signed consent for post mortem tissue donation and autopsy Exclusion Criteria: Signed consent for post mortem tissue donation and autopsy not obtained
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pediatric patients with cancer and non-cancer tumor types<br>Pediatric patients with cancer and non-cancer tumor types (solid, liquid, neuro-oncology and stem cell) | Other: Collection of post mortem tissue donation<br>* Collection of post mortem tissue from pediatric participants with cancer and non-cancer tumor types from whom post mortem tissue donation and autopsy consent is obtained.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procurement of pediatric cancer and non-cancer tumor tissue during autopsy with signed consent | Procurement of pediatric cancer and non-cancer tumor tissue during autopsy with signed consent. Tissue will be collected through a research tissue collection autopsy of the original tumor and other sites that are appropriate. Samples of both tumor and normal cells will be collected in addition to body fluids such as cerebrospinal fluid (CSF), blood, bone marrow, and skin biopsies for genomic testing. | Up to 5 years from procurement |
Ultrasound Guided Artificial Insemination

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to ascertain whether using ultrasound guidance during intrauterine insemination (IUI) could increase pregnancy rates.

Conditions
-----------------
Insemination

Intervention / Treatment
-----------------
* Procedure: recombinant FSH


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The woman's inclusion criteria in our IUI program were at least one patent tube, normal cavity, basal FSH < 10 mU/mL and age under 40 years. IUI with husband's sperm (IUI-H) was indicated when, after sperm preparation, at least 5 million motile spermatozoa were recovered; this was performed in 58 cases (79.45%). In the remaining 15 cases (20.55%), IUI was performed with donor sperm (IUI-D) either because of azoospermia (n=6) failure to recover spermatozoa during testicular biopsy (n=5) or in women without a male partner (n=4). Exclusion Criteria: Previous infertility treatments had been carried out.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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 |
| --- | --- |
| Recombinat FSH<br> | Procedure: recombinant FSH<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Relationship Between Delirium Severity by CAM-ICU 7 and 4C Mortality Score of the COVID-19 Patients in ICU

Study Overview
=================
Brief Summary
-----------------
Aim: to investigate whether the 4C Mortality score, which measures the severity of COVID-19, and the CAM-ICU 7 score , which measures the severity of delirium, in ICU. To compare two scores in terms of the number of days without intubation and 28 day mortality rates in ICU.

Official Title
-----------------
Relationship Between Delirium Severity by CAM-ICU 7 and 4C Mortality Score of the COVID-19 Patients in ICU

Conditions
-----------------
Delirium, Covid19, Intensive Care Unit Delirium

Intervention / Treatment
-----------------
* Other: CAM-ICU 7 score
* Other: 4C Mortality Score


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:Patients hospitalized in the intensive care unit diagnosed with COVID-19 will include in the study Exclusion Criteria:there is no exclusion criteria

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 |
| --- | --- |
| Intensive care unit delirium<br>Covid-19 patients in ICU are screened for delirium and rated the severity with CAM-ICU 7 scores. | Other: CAM-ICU 7 score<br>* A 7-point rating scale (0-7) was derived from the CAM-ICU and RASS assessments 0-2: no delirium, 3-5: mild to moderate delirium, and 6-7: severe delirium.<br>Other: 4C Mortality Score<br>* 4C Mortality Scores of the patients will be calculated, according to age, gender, number of comorbidities, respiratory rate, SpO2, GCS, urea, and CRP parameters<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28 day mortality | 28 day mortality | 28 days |
Prospective Validation of the Prognostic Value of Long Non-coding MFI2-AS1 RNA in Localized Clear Cell Kidney Cancers

Study Overview
=================
Brief Summary
-----------------
An exploratory analysis of the expression of MFI2-AS1 will be performed at the plasma level with the objective of comparing this expression with tumor tissue. The objective would be to be able to use long non-coding RNA as a biomarker for diagnosis before tissue analysis and for patient follow-up. In addition, correlations will be made between tumor expression of MFI2-AS1 and genetic and immune alterations in tumors in order to better clarify the link between the expression of this long non-coding RNA and the characteristics of the tumor and of the tumor. tumor microenvironment.

Official Title
-----------------
Prospective Validation of the Prognostic Value of Long Non-coding MFI2-AS1 RNA in Localized Clear Cell Kidney Cancers

Conditions
-----------------
Kidney Cancer

Intervention / Treatment
-----------------
* Procedure: Surgical intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patient Localized kidney tumors> T1a Patient having signed an informed consent Patient affiliated to a health insurance plan Subject having signed a consent form to participate in research and the constitution of a collection and genetic analyzes Exclusion Criteria: Metastatic carcinoma from the outset Contraindication to performing a TAP CT with injection of contrast product Inability to provide informed information about the subject (subject in an emergency situation, difficulties in understanding, etc.) Subject under legal protection Subject under tutorship or curatorship Pregnancy Feeding with milk

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Surgical intervention|Surgical intervention with collection of tissue material|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expression of MFI2-AS1 | To assess the link between tumor expression of MFI2-AS1 in patients with localized clear cell kidney carcinoma and the occurrence of relapse | 36 month |
Prostate Immobilization Device Used During Radiation Treatments to Decrease Rectal Bleeding

Study Overview
=================
Brief Summary
-----------------
During 3D-conformal external beam radiation therapy treatments for prostate cancer, the prostate gland moves. The purpose of this study is to determine whether the placement of a prostate immobilization device into the rectum during radiation treatments will decrease the risk of rectal bleeding that is sometimes seen as a late effect from radiation.

Detailed Description
-----------------
MRI using an endorectal coil done prior to treatment for staging. Baseline Quality of Life (QOL) assessment will be completed prior to treatment. Total androgen suppression is initiated and will continue for at least 6 months. Prostate Immobilization Device (PID) placed during the planning session. PID will be placed daily for the first 15 3D external beam radiation treatments. QOL assessment and follow-up will take place every 6 months for 3 years.

Official Title
-----------------
A Phase II Study of Late Rectal Toxicity Following 3-D Conformal External Beam Radiation Therapy Performed Using a Prostate Immobilization Device

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Biopsy proven prostate cancer Clinical Stage T1 - T4 Negative bone scan PSA and routine blood work >30 years of age ECOG Performance 0,1, or 2 No prior pelvic radiation No pacemaker Exclusion Criteria: Inflammatory bowel disease (Crohns, or Ulcerative Colitis) Prostatic rectal fistula Stricture of anal canal

Ages Eligible for Study
-----------------
Minimum Age: 31 Years
Maximum Age: 80 Years

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

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 |
| --- |
|Device: Prostate Immobilization Device|Device placed during radiation treatment|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rectal toxicity at six month intervals |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life |  | 2 years | 
| urinary symptoms |  | 2 years | 
| sexual dysfunction at six month intervals |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Total Androgen Suppression, Simulation, 3-D Conformal External Beam Radiation Therapy, Intra-rectal immobilization device, Quality of Life Assessment Questionnaire, Rectal Bleeding, Late effects