linjc16/ctgov huggingface dataset:
Evaluation of the Three-Seeds Mixture Treatment in Chronic Obstructive Pulmonary Disease Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test whether the three-seeds mixture tea reduces sputum and/or cough in COPD patients, and if so, to evaluate whether the three-seeds mixture changes the lung microbiome.

Official Title
-----------------
Evaluation of the Three-Seeds Mixture Treatment in Chronic Obstructive Pulmonary Disease Patients: A Pilot Study

Conditions
-----------------
Cough

Intervention / Treatment
-----------------
* Dietary Supplement: Three-seeds mixture
* Dietary Supplement: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or females ages 50-80 at the time of entry Non-smoker for at least 1 year Chronic bronchitis with Fev1 <80% and Fev1/ Fvc <0.7 and daily sputum production Documentation of COPD. We define COPD as the presence of irreversible airflow obstruction, presence of emphysema on CT scan or both. This determination will be by the pulmonary physicians leading this study. Ability and willingness to provide informed consent. Exclusion Criteria: 1. Current Smoker 2. Asthma or other respiratory diseases 3. Frail patients (unintended weight loss, long term fatigue). 4. Patients with acute COPD exacerbation -

Ages Eligible for Study
-----------------
Minimum Age: 50 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tea1 group<br>This is the treatment group. This group will be taking 2 grams of the three-seeds mixture twice a day for three weeks. | Dietary Supplement: Three-seeds mixture<br>* mixture of white mustard seeds, radish seeds and beefsteak plant (Korean perilla, a species of Perilla in the mint family, widely cultivated and edible for humans; a daily food for Korean people; many Japanese people drink as tea) seeds<br>|
| Placebo Comparator: Tea2 group<br>This is the control group. This group will be taking 0.02 grams of the three-seeds mixture once a day for three weeks. | Dietary Supplement: Control<br>* warm water with negligible amount of the three-seeds mixture<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sputum and cough score | Sputum and cough measured by Cough and Sputum Assessment Questionnaire. The minimum score of this questionnaire is 0, and the maximum score is 100, with lower scores indicating higher symptom/impact levels. The total score will be reported. The score will be summed to a total score. | One month |
A Study Comparing the Pharmacokinetics and Tolerance of D-Gam® to Rhophylac® in Rh-D-negative Healthy Volunteers.

Study Overview
=================
Brief Summary
-----------------
The primary objective of the study was to compare peak serum anti-D levels (Cmax) of BPL's D-Gam® 1500 IU to Rhophylac® 1500IU in RhD-negative healthy volunteers.

Official Title
-----------------
A Randomised Study Comparing the Pharmacokinetics and Tolerance of D-Gam® 1500IU to Rhophylac® 1500IUin Rh-D-negative Healthy Volunteers.

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Biological: D-Gam® (human anti-D immunoglobulin)
* Biological: Rhophylac® (human anti-D immunoglobulin)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Females Ages of 18 and 55 years Bodyweight of 50-85kg. Exclusion Criteria: Clinically relevant abnormalities at physical examination, ECG or laboratory tests.
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: D-Gam®<br>D-Gam® (human anti-D immunoglobulin) | Biological: D-Gam® (human anti-D immunoglobulin)<br> <br> |
| Active Comparator: Rhophylac®<br>Human Anti-D Immunoglobulin | Biological: Rhophylac® (human anti-D immunoglobulin)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax for anti-D |  | Pre-dose, 1, 8, 24, 32, 48, 72 & 96 hours; 1, 2, 3, 4, 5, 6, 8, 10, 12 & 14 weeks post-dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Volunteers
Safety and Efficiency of γδ T Cell Against Non Small Lung Cancer ( Without EGFR Mutation)

Study Overview
=================
Brief Summary
-----------------
In this study, effects of γδT cells on human non small lung cancer ( without EGFR mutation) in combination with tumor reducing surgery, for example cryosurgery going to be investigated.

Detailed Description
-----------------
Non small lung cancer will be removed using tumor reducing surgery such as cryosurgery. PBMC of the patient will be separated from peripheral blood. After making them potential cancer killer γδ T Cell and DC-CIK, they will be infused to the patients as immunotherapy.

Official Title
-----------------
γδ T Cell Immunotherapy for Treatment of

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Biological: DC-CIK
* Biological: γδ T Cell
* Biological: γδ T/DC-CIK cells


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age:18-75 Karnofsky performance status >50 Diagnosis with non small lung tumors based on histology or the current accepted radiological measures. Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ Will receive cryosurgery, gd Tcells/ DC-CIK. Life expectancy: Greater than 3 months Ability to understand the study protocol and a willingness to sign a written informed consent document Exclusion Criteria: Patients with other kinds of cancer History of coagulation disorders or anemia Patients with heart disease and diabetes

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>DC-CIK cells will be used against tumor cells. | Biological: DC-CIK<br>* DC-CIK cells will be used against tumor cells.<br>|
| Experimental: Group B<br>γδ T cells will be used against tumor cells. | Biological: γδ T Cell<br>* γδ T cells will be used against non small lung tumor.<br>|
| Experimental: Group C<br>Combination of γδ T cells/ DC-CIK be used against tumor cells. | Biological: γδ T/DC-CIK cells<br>* γδ T/DC-CIK cells will be used against lung tumor.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduced size of the tumor. |  | Up to one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
γδ T Cell, non small lung cancer, Without EGFR Mutation
Early Versus Delayed Laparoscopic Cholecystectomy Following ERCP in Concomitant Gallstones and Common Bile Duct Stones

Study Overview
=================
Brief Summary
-----------------
The present study aimed to compare early and delayed laparoscopic cholecystectomy after ERCP for CBDs and gallstones.

Detailed Description
-----------------
Endoscopic retrograde cholangiopancreatography (ERCP) followed by laparoscopic cholecystectomy (LC) is a commonly performed treatment modality for concomitant common bile duct stones (CBDs) and gallbladder stones. There has been a debate about the appropriate timing of laparoscopic cholecystectomy after ERCP. The present study aimed to compare early and delayed laparoscopic cholecystectomy after ERCP for CBDs and gallstones adding new parameters like Nassar scale.

Official Title
-----------------
Early Versus Delayed Laparoscopic Cholecystectomy Following ERCP in Concomitant Gallstones and Common Bile Duct Stones

Conditions
-----------------
Choledocholithiasis With Cholecystitis

Intervention / Treatment
-----------------
* Procedure: Laparoscopic cholecystectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who underwent laparoscopic cholecystectomy after clearance of CBDs by ERCP Exclusion Criteria: advanced liver cirrhosis, pancreatitis, acute cholangitis, suspected malignancy, severe malnutrition, and pregnancy.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 80 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Early group<br> | Procedure: Laparoscopic cholecystectomy<br>* Laparoscopic cholecystectomy performed after ERCP<br>|
| Active Comparator: Delayed group<br> | Procedure: Laparoscopic cholecystectomy<br>* Laparoscopic cholecystectomy performed after ERCP<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| operative time | the time to perform laparoscopic cholecystectomy from the time of incision to the last suture | one day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intraoperative difficulty and complications | the difficulties that face the surgeon during the surgery and the early complications that result | one day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Choledocholithiasis, Early, Delayed, Laparoscopic cholecystectomy, ERCP, Nassar scale
Revlimid® Capsules General Drug Use-results Surveillance (Relapsed or Refractory FL and MZL)

Study Overview
=================
Brief Summary
-----------------
To ascertain the safety of Revlimid® Capsules 2.5 mg or 5 mg under the actual use conditions in patients who received R2 combination therapy with the drug and rituximab for the first time for relapsed or refractory follicular lymphoma (FL) or marginal zone lymphoma (MZL). In particular, this surveillance will collect only information of occurrence state and treatment methods on bone marrow depression (neutropenia), which is specified as a safety specification, as well as on tumor flare, for which attention should be called. Planned registration period 1.5 years Planned surveillance period 3 years from the start of this survey

Official Title
-----------------
Revlimid® Capsules General Drug Use-results Survey (Relapsed or Refractory Follicular Lymphoma and Marginal Zone Lymphoma)

Conditions
-----------------
Lymphoma Nonhodgkin

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Relapsed or Refractory Follicular Lymphoma or Marginal Zone Lymphoma Exclusion Criteria: N/A

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 |
| --- | --- |
| Participants with FL or MZL<br>Patients who have been diagnosed with follicular lymphoma (FL) or marginal zone lymphoma (MZL) who receive R2 combination therapy with revlimid and rituximab for the first time. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events (AEs) | Number of participants with adverse events | Up to approximately 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lymphoma, Nonhodgkin, low-grade, B-cell, Follicular, Marginal zone, Safety, Revlimid, Rituximab, Actual use conditions, R2 combination therapy, Bone marrow depression, Neutropenia, Tumor flare
Autologous Stem Cell Transplantation for Myeloma Patients Over 65 Years

Study Overview
=================
Brief Summary
-----------------
Autologous stem cell transplantation remains the gold standard of treatment for newly diagnosed patients under the age of 65. Even though it is also regularly performed above the age of 65, there are very few data in this patient population. The investigators will capture safety and efficacy data in that setting.

Detailed Description
-----------------
Newly diagnosed myeloma patients above the age of 65 years will be treated the following way: Bortezomib (Velcade®) based induction treatment (either Velcade Dexamethasone, Velcade Thalidomide Dexamethasone (VTD) or Velcade Cyclophosphamide Dexamethasone (VCD)). After the induction phase, for patients at least in partial remission, a collection of peripheral blood stem cells (PBSC) is done according to each center practice. High dose melphalan (140 mg/m2) followed by PBSC autologous transplantation is then performed. Three months post transplant, 2-3 cycles (similar to the initial induction phase) of consolidation are allowed.

Official Title
-----------------
Prospective, Observational, Multicenter Trial Evaluating Autologous Stem Cell Transplantation for Myeloma Patients Over the Age of 65

Conditions
-----------------
Newly Diagnosed Myeloma Patient Above 65 Years Old

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: newly diagnosed MM, age over 65, measurable disease Exclusion Criteria: Patients less than 65 and/or not proceeding to autologous PBSC transplantation

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 |
| --- | --- |
| above 65 years old<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free survival |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response |  | after induction, 3 months post transplant, 2 months post consolidation | 
| Time To Progression |  | 2 years | 
| Overall Survival |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multiple Myeloma, Autologous Stem Cell Transplantation, Elderly Patients
Cohort of HIV-infected Children

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to describe the conditions of access to early treatment of children infected with HIV, their management on the long-term, and impact on growth, clinical and immunovirological prognosis, adherence to treatment, living conditions

Detailed Description
-----------------
The CO10 EPF paediatric cohort includes therapeutic, clinical and biological detailed questionnaires. The data are collected by the doctors every three months to 2 years and then every 6 months until to 18 years or every year by a simplified questionnaire if medical follow up continues outside of a participating site. After 18 years of age, the patients are eligibile for the ANRS CO19-Coverte cohort.

Official Title
-----------------
ANRS CO10 EPF - Cohort of HIV-infected Children

Conditions
-----------------
Children Infected by HIV

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV-infected children born to mothers included in ANRS-CO1 EPF or children under the age of 13 newly entered in care management with no prior antiretroviral therapy, whose mother was or not included in ANRS-CO1 EPF Exclusion Criteria: >= 13 years refusal of legal representative of the child antiretroviral therapy started before the entry in care management care management for over 6 months before inclusion

Ages Eligible for Study
-----------------
Maximum Age: 13 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 |
| --- | --- | --- |
| Conditions of access to early treatment | social factors (Geographical origin, living conditions, school level, age) and infection stage | At inclusion and every six months up to 18 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Puberty stage | Tanner classification | At 8 years and every six months up to 18 years | 
| Clinical prognosis | Health status (lipodystrophy, metabolic abnormalities, cardiovascular diseases, encephalopathy, Developmental delay, CDC stage) | At inclusion and every six months up to 18 years | 
| Immuno virological prognosis | HIV RNA<50c/mL, CD4 cells count > 500 cells/mL, Genotypic resistance | At inclusion and every six months up to 18 years | 
| Prognosis of patient coinfected by CMV or VHC | Adverse events of treatments (complications) | At inclusion and every six months up to 18 years | 
| Sexuality | sexual risk behaviour (age at first intercourse, condom use at first, contraception, pregnancy, interruption of pregnancy) | At 15 years and every six months up to 18 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV Infection, Adolescent
IFH Depression Registry 2013

Study Overview
=================
Brief Summary
-----------------
This is an observational registry intended to track depression scores of patients over time in treatment.

Conditions
-----------------
Depression

Intervention / Treatment
-----------------
* Behavioral: Standard Behavioral treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with PHQ-9 score greater than or equal to 10, have a depression diagnosis active on the problem list, or have had a depression encounter diagnosis used in the past year, and are in behavioral health treatment at the Institute. Exclusion Criteria: Patients under the age of 18

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 |
| --- | --- |
| IFH Patients on Depression Registry<br>Patients at the Institute for Family Health who have a diagnosis of depression active on their problem list or have had a diagnosis of depression used as an encounter diagnosis in the past year or patients with a PHQ-9 score greater than or equal to 10. | Behavioral: Standard Behavioral treatment<br>* Standard behavioral treatment (e.g. problem solving therapy, cognitive behavioral treatment)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression scores on PHQ-9 depression screening | Comparing depression scores for patients in treatment at initiation and after 16 weeks. | 16 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
depression, phq9, phq-9, standard treatment
Pelvic Floor Function After Vaginal and Cesarean Delivery Among Egyptian Women

Study Overview
=================
Brief Summary
-----------------
A cross sectional study for assessment of pelvic floor functions after 6 months to 4 years after normal vaginal delivery or Cesarean section

Detailed Description
-----------------
A cross sectional study for assessment of pelvic floor functions after 6 months to 4 years after normal vaginal delivery or Cesarean section Four separate entities were evaluated using internationally recognized and validated questionnaires: Pelvic organ prolapse evaluated using the Pelvic Organ Prolapse Distress Inventory Urinary functions were evaluated using the International Consultation on Incontinence Questionnaire Short Form Fecal incontinence was evaluated using Wexner Fecal Incontinence Score Sexual functions were evaluated using female sexual function index

Official Title
-----------------
Evaluation of Pelvic Floor Function After Vaginal and Cesarean Delivery Among Egyptian Women

Conditions
-----------------
Pelvic Floor Disorders

Intervention / Treatment
-----------------
* Diagnostic Test: female sexual function index


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: primiparity, singleton pregnancy cephalic presentation term delivery (38-42 weeks). Exclusion Criteria: Women with operative vaginal delivery (vacuum extraction or forceps delivery) women who had another delivery between the time of first one and time of evaluation women with neurological diseases women with vascular diseases and Diabetes Mellitus

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| vaginal delivery<br>Women underwent non complicated non instumental normal vaginal delivery | Diagnostic Test: female sexual function index<br>* evaluation of sexual functions questionnaire about Desire, Arousal, Orgasm,pain , lubrications, satisfactions<br>|
| Cesarean section<br>Women underwent elective Cesarean section | Diagnostic Test: female sexual function index<br>* evaluation of sexual functions questionnaire about Desire, Arousal, Orgasm,pain , lubrications, satisfactions<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| urinary incontinence | evaluation using the International Consultation on Incontinence Questionnaire Short Form | 6 months after delivery |