linjc16/ctgov huggingface dataset:
Prospective Pilot Study of Multimodal Radiological Evaluation Feasibility During Chemoradiotherapy of Rectal Adenocarcinomas

Study Overview
=================
Brief Summary
-----------------
The objective of the present project is to validate the feasibility of a multimodal radiological pathway while on chemoradiotherapy, in order to validate potentially predictive factors for chemoradiotherapy sensitivity of rectal adenocarcinomas.

Detailed Description
-----------------
The objective of the present project is to validate the feasibility of a multimodal radiological pathway while on chemoradiotherapy, in order to validate potentially predictive factors for chemoradiotherapy sensitivity of rectal adenocarcinomas. It is based on a structured clinical and radiological pathway for patients, using diffusion MRI and F misonidazole PET. Validation of these new tools is already needed in clinical practice since future institutional trials will be based on treatment individualisation, using preoperative predicting factors.

Official Title
-----------------
Prospective Pilot Study of Multimodal Radiological Evaluation Feasibility During Chemoradiotherapy of Rectal Adenocarcinomas.

Conditions
-----------------
Rectal Adenocarcinoma

Intervention / Treatment
-----------------
* Procedure: Pelvic MRI and F MISO TEP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: locally advanced (≥T3) resectable rectal adenocarcinoma between 2 and 10 cm from the anal verge. Exclusion Criteria: synchonous metastatis previous malignant tumour previous radiotherapy/ chemotherapy performance status WHO>2 contraindication to 5 FU

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?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br> | Procedure: Pelvic MRI and F MISO TEP<br>* Pelvic MRI and F MISO TEP: before inclusion, 2 weeks after beginning and 7 weeks after completion of chemoradiotherapy.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| acceptation rate of the entire sequence by eligible patients | acceptation rate of the entire sequence by eligible patients | 13 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| radiological changes while on chimiotherapy, to tumour regression, and prognosis | radiological changes while on chimiotherapy, to tumour regression, and prognosis | 13 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chemotherapy, rectal adenocarcinoma, proctectomy, Fmiso TEP, MRI
Antenatal COVID 19 Vaccination and Pregnancy Outcomes

Study Overview
=================
Brief Summary
-----------------
Effect of COVID 19 vaccinations on pregnancy outcomes must be clear and identified to detect their safty

Detailed Description
-----------------
in this study we will discuss side effects of COVID 19 vaccine on pregnant women including the incidence of miscarrage , intrauterine fetal deaths, liquor abnormalities, preeclampsia, accidental hemorrhage , we also will follow up pregnant women who received any type of COVID 19 vaccine till delivery and discuss the effect of the vaccine on fetus and newborn

Official Title
-----------------
Antenatal COVID 19 VACCINATION and Pregnancy Outcomes

Conditions
-----------------
Effect of Drug

Intervention / Treatment
-----------------
* Biological: pfizer, astrazeneca,moderna,sinofac


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant women aged 18 years or older who received any type of COVID 19 vaccine during current pregnancy Exclusion Criteria: comorbidities,women who refused participqtion,pregnant women with previous COVID 19 infection during current pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: pfizer, astrazeneca,moderna,sinofac|effect of COVID 19 vaccination on pregnancy outcomes|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pregnancy loss | miscarrage or intrauterine fetal death | in first, second, third trimester | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fetal malformations | detected by detailed anomaly scan | at each trimester | 
| pregnancy related hypertensive disorders | blood pressure higher than 140/90mmHg starting from 20 weeks of gestation | starting from 20 weeks of gestation |
Pharmacokinetics of Pavaverine After Intraluminal Administration

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the pharmacokinetic of papaverine after administration into the artery mammaria interna.

Official Title
-----------------
Observational Study on Papaverine During Cardiac Surgical Procedures

Conditions
-----------------
Injury of Internal Mammary Artery, Complications Due to Coronary Artery Bypass Graft

Intervention / Treatment
-----------------
* Procedure: CABG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CABG Administration of papaverine into mammaria interna Exclusion Criteria: Allergy against papaverine

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 |
| --- | --- |
| CABG with papaverine<br>Patients with CABG procedure | Procedure: CABG<br>* Preparation of artery mammaria interna<br>* Other names: Paveron N;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum plasma concentration of papaverine | Serum probes will be analysed for the concentrations of papaverine. | 4 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
papaverine, pharmacokinetic, CABG, Injury of Internal Mammary Artery, Complications Due to Coronary Artery Bypass Graft
A Randomized, Controlled Study to Evaluate the Sensitizing Potential of FMX-101 in Healthy Volunteers Using a Repeat Insult Patch Test Design

Study Overview
=================
Brief Summary
-----------------
A Randomized, Controlled Study to Evaluate the Sensitizing Potential of FMX-101 in Healthy Volunteers Using a Repeat Insult Patch Test Design

Official Title
-----------------
A Randomized, Controlled Study to Evaluate the Sensitizing Potential of FMX-101 in Healthy Volunteers Using a Repeat Insult Patch Test Design

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

Intervention / Treatment
-----------------
* Drug: FMX-101


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female age 18 and older who was healthy Was of any Fitzpatrick Skin Type or race, providing the skin pigmentation allowed for discernment of erythema Exclusion Criteria: -

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

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

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

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: FMX-101<br> | Drug: FMX-101<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of recurrence of a cutaneous response at Rechallenge equivalent to or more severe than that observed at Challenge. |  | 8 weeks |
Evaluation of a Tailored Virtual Intervention to Empower Persons Living With HIV for Therapy Self-management

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy of an online virtual intervention in optimizing adherence to antiretroviral medication intake among Persons Living with HIV (PLHIV).

Conditions
-----------------
HIV

Intervention / Treatment
-----------------
* Behavioral: VIH-TAVIE


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: have to be under ART for at least six months¸ have internet access Exclusion Criteria: be pregnant active IV drug user actual diagnosis of psychiatric health problem

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Web sites<br>Patients assigned to this arm are given a list of Web sites where they can collect information related to their condition at their leisure. | |
| Experimental: VIH-TAVIE<br>Patients assigned to this arm must follow the four interactive computer sessions | Behavioral: VIH-TAVIE<br>* The tailored virtual intervention is composed of four interactive computer sessions hosted by a virtual nurse who engages the PLHIV in a medication-intake self-management skills-learning process.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence | Adherence will be evaluated through a self-administered questionnaire that was developed for and validated on the targeted population (Godin, Gagné, & Naccache, 2003). The questionnaire comprises seven items that serve to determine how many times a person forgets to take his or her medication. The questionnaire's validity was demonstrated (sensitivity: 71 %; specificity: 72%; correct classification: 72%; odds ratio: 6.15) using immunologic (CD4 count) and virologic (viral load) parameters as validation criteria. Adherence is defined as the intake of at least 95% of prescribed tablets. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adherence, HIV, antiretroviral therapy, tailored web intervention
Carelizumab Combined With Regorafenib in the Treatment of HCC（CARE-2020）

Study Overview
=================
Brief Summary
-----------------
To investigate the efficacy and safety of carelizumab combined with regorafenib in second-line treatment for patients with primary hepatocellular carcinoma.

Detailed Description
-----------------
Currently, there is little experience in the application of targeted drugs combined with immunotherapy. Through this study, we hope to explore the optimal population for the use of carelizumab combined with regorafenib in the second-line treatment of hepatocellular carcinoma (HCC), as well as the efficacy and safety. This research is a single-center trials phase II second-line, single arm, explore the clinical outcome of treatment.

Official Title
-----------------
A Phase II, Second-line, Single-arm Clinical Trial of Carelizumab Combined With Regorafenib in the Treatment of Advanced Hepatocellular Carcinoma

Conditions
-----------------
Hepatocellular Carcinoma

Intervention / Treatment
-----------------
* Drug: Regorafenib Pill&Camrelizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Not convenient to disclose Exclusion Criteria: Not convenient to disclose

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Carelizumab Combined With Regorafenib arm<br> | Drug: Regorafenib Pill&Camrelizumab<br>* Regorafenib，80 mg，QD，Q3w Camrelizumab，200 mg，IV，Q3w<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| os（overall survival） | overall survival | 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS（progression-free survival） | progression-free survival | 21 days | 
| TTP（Time-To-Progression） | Time-To-Progression | 21 days | 
| ORR（Overall Response Rate） | Overall Response Rate | 21 days | 
| DCR（disease control rate） | disease control rate | 21 days | 
| DoR | Duration of Response | 21 days |
The Acute Effects of Coffee on Glucose Metabolism

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to determine the acute effects of decaffeinated coffee, caffeinated coffee and caffeine on glucose metabolism in humans

Official Title
-----------------
Human Trial of the Acute Effects of Coffee on Glucose Metabolism

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

Intervention / Treatment
-----------------
* Other: decaff
* Other: caffcoff
* Other: caffeine
* Other: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy young males nonsmokers moderate alcohol users Exclusion Criteria: not on any medications that could alter glucose metabolism no history of blood disorders

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: decaff|2 mugs of decaffeinated coffee|
|Other: caffcoff|2 mugs of caffeinated coffee|
|Other: caffeine|2 mugs of hot water containing caffeine|
|Other: placebo|2 mugs of hot water|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma glucose levels |  | 0, 10, 30, 60, 90, and 120 minutes. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma insulin |  | 0, 10, 30, 60, 90, and 120 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
coffee, caffeine, glucose metabolism, insulin sensitivity, diabetes
Ramipril in Pediatric Patients on Hemodialysis

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate the effect of Ramipril in pediatric patients on regular hemodilaysis

Detailed Description
-----------------
Evaluate the effect of Ramipril on blood pressure, heart rate, Endothelial dysfunction and inflammatory markers in pediatric patients on regular hemodilaysis and the correlation of response with ACE I/D polymorphisms.

Official Title
-----------------
Impact of Angiotensin-converting Enzyme Inhibitor on Pediatric Hemodialysis Patients

Conditions
-----------------
Hemodialysis

Intervention / Treatment
-----------------
* Drug: Ramipril
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients < 16 years old Patients who have been on regular HD for 6 months or longer Hypertension at enrollment Exclusion Criteria: History of active connective tissue disease Acute infection within 1 month prior to the study Advanced liver disease Gastrointestinal dysfunction requiring parental nutrition or active malignancy Use of medications such as immunosuppressive drugs within 1 month prior to the study Use of anti-inflammatory medications Use of vitamin E at a dose higher than 60 IU per day or vitamin C higher than 500 mg per day History of myocardial infarction or cerebrovascular event within 3 months prior to the study History of ACE inhibitor-associated angioedema Inability to discontinue ACE inhibitors or ARBs

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 16 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: Ramipril<br>Ramipril, 2.5 mg daily, administered orally for 16 weeks | Drug: Ramipril<br>* angiotensin-converting enzyme inhibitor<br>* Other names: Tritace;|
| Placebo Comparator: Placebo<br>Placebo, matched for the interventional drug, administered orally, daily for 16 weeks | Drug: placebo<br>* same odor, color and size as the drug but without the active ingredient<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| concentration of Asymmetric dimethylarginine (ADMA) | marker of endothelial dysfunction | 16 weeks | 
| concentration of high-sensitivity C-reactive protein (Hs-CRP ) | marker of inflammation | 16 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
angiotensin-convertting enzyme inhibitor, ramipril
Treatment of Non-alcoholic Steatohepatitis (NASH) Patients With Vitamin D

Study Overview
=================
Brief Summary
-----------------
Test the efficacy of vitamin D to improve non-alcoholic steatohepatitis with regard to biochemical and histological parameters. Trial with medicinal product

Conditions
-----------------
Non-alcoholic Steatohepatitis (NASH)

Intervention / Treatment
-----------------
* Drug: Vitamin D3
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patients with 25-OH vitamin D insufficiency Elevated alanine aminotransferase level Diagnosis of definite or possible steatohepatitis (NASH) Exclusion criteria: Cirrhosis, present liver disease other than NASH Serious diseases limiting life expectancy, Breast-feeding or pregnant women Unhealthy alcohol consumption Drug abuse or substitution therapy Use of vitamin preparations within the previous 6 months and during the study Weight loss >5% within 12 months before study entry Newly diagnosed Diabetes mellitus requiring medical treatment within 12 months before study entry Use of anti-obesity drugs Previous or current hypercalcemia Chronic renal disease

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: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin D3<br> | Drug: Vitamin D3<br>* Vitamin D3, 2.100 IU/d p.o.<br>Drug: Placebo<br>* Placebo Tbl. p.o.<br>|
| Placebo Comparator: Placebo<br> | Drug: Vitamin D3<br>* Vitamin D3, 2.100 IU/d p.o.<br>Drug: Placebo<br>* Placebo Tbl. p.o.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in serum alanine aminotransferase levels at week 48 |  | Measurement at week 0 and week 48 |
Effects of Innovative Aerobic Exercise Training in Cystic Fibrosis

Study Overview
=================
Brief Summary
-----------------
This study will be a randomized controlled trial in patients with cystic fibrosis and conducted over a consecutive twelve-week period. A comparison standard of care group will be used as a control to an interventional exercise group. The study evaluates the effectiveness of standard of care therapy + exercise compared to standard of care only for improving cardiorespiratory-fitness in CF patients.

Official Title
-----------------
Effects of Innovative Aerobic Exercise Training in Cystic Fibrosis

Conditions
-----------------
Cystic Fibrosis

Intervention / Treatment
-----------------
* Behavioral: exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosed with Cystic Fibrosis Prescribed and taking for 28 days ivacaftor-tezacaftor-elexacaftor (Trikafta) 18 years and older Exclusion Criteria: 17 years of age or less not eligible for ivacaftor-tezacaftor-elexacaftor (Trikafta) inability to exercise pregnancy status post lung transplantation already participating in more than 150 minutes of aerobic exercise per week

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: exercise<br>exercise prescription + standard of care | Behavioral: exercise<br>* partially supervised and home-based exercise activity<br>|
| No Intervention: no exercise<br>no exercise prescription + standard of care | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aerobic Exercise Capacity | anaerobic threshold via Sub-maximal cardiopulmonary exercise test | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pulmonary function | forced expiratory volume in 1 second (FEV1) | 3 months | 
| Quality of Life measured by CFQ-R | cystic fibrosis questionnaire (CFQ-R) score | 3 months | 
| Impact on sweat chloride | Sweat Chloride Testing | 3 months | 
| diabetes risk | Point-of-Care HbA1c | 3 months |