linjc16/ctgov huggingface dataset:
Bio-availability of a New Liquid Tumeric Extract

Study Overview
=================
Brief Summary
-----------------
Curcumin is a commonly-used spice and food coloring. Evidence suggests that curcumin can suppress tumor initiation, promotion and metastasis in a variety of tumor cell lines. The current available curcumin has low bioavailability restricting the effect of curcumin in non-colon cancer. In this study we plan to test a new liquid tumeric/curcumin extract, Curcumol (patent pending, Israel Patent Application No. 181,121). We predict the bioavailability of the liquid tumeric/curcumin extract will be better compared to the currently used curcumin powder.

Detailed Description
-----------------
Twelve healthy participants enrolled to the study. All volunteers will have pre study evaluation to confirm healthy state. After enrollment, each participant will be tested twice, one with the liquid tumeric/curcumin (study drug) and once with the curcumin powder (control). The days of testing will be on two days, separated by two weeks wash-out period. The participants will be assigned to randomly receive study drug or control on the 1st day, with the other regimen administered at the 2nd day. Both study drug and control will be diluted in 150ml of water. The doe of study drug will be escalated from 30 drops (4 participants), 50 drops (4 participants) and 70 drops (4 participants). Blood sample will be collected at 0,0.25,0.5,0.75,1,2,3,4,5,6,8h post drug. Quantization of curcumin plasma levels will be done by the high pressure liquid chormatography method. A biomarker for the potential effect of curcumin, platelet function pre and post curcumin consumption will be tested.

Official Title
-----------------
Liquid Tumeric Extract for Increasing Bio-availability of Curcumin in the Human Body: Pharmacokinetic Study.

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

Intervention / Treatment
-----------------
* Drug: liquid tumeric/curcumin extract


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Complete Healthy Able to attend two full days of study

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: liquid tumeric/curcumin extract|30 drops (4 participants), 50 drops (4 participants) and 70 drops (4 participants). one dose.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy subjects, Curcumin, Bioavilability
Amniotic Fluid Lactate in Perterm Premature Rupture of Membranes

Study Overview
=================
Brief Summary
-----------------
AF lactate level could help in predicting the duration from ROM till delivery

Official Title
-----------------
Amniotic Fluid Lactate in Predicting Latency in Perterm Premature Rupture of Membranes

Conditions
-----------------
Rupture of Membranes; Premature

Intervention / Treatment
-----------------
* Diagnostic Test: amniotic fluid lactate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women with PPROM GA between 24 to 34 weeks Exclusion Criteria: chorioamnionitis previous Preterm labor abruptio placentae UTI ,pyelonephritis

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 35 Years

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

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

| Intervention/Treatment |
| --- |
|Diagnostic Test: amniotic fluid lactate|AF lactate|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| latency period | duration from ROM till the occurrence of active labor | upto 48 hours |
A Study of Nivolumab in Participants With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation

Study Overview
=================
Brief Summary
-----------------
This study will investigate if nivolumab will improve recurrence-free survival (RFS) compared to placebo in participants with HCC who have undergone complete resection or have achieved a complete response after local ablation, and who are at high risk of recurrence

Official Title
-----------------
A Phase 3, Randomized, Double-blind Study of Adjuvant Nivolumab Versus Placebo for Participants With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation

Conditions
-----------------
Hepatocellular Carcinoma, Liver Cancer

Intervention / Treatment
-----------------
* Biological: Nivolumab
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants with a first diagnosis of HCC who have undergone a curative resection or ablation Participants are eligible to enroll if they have non-viral related-HCC, or if they have HBV-HCC, or HCV-HCC Child-Pugh Score 5 or 6 Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 Exclusion Criteria: Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC Any evidence of tumor metastasis or co-existing malignant disease Participants previously receiving any prior therapy for HCC, including loco-regional therapies Participants who have undergone a liver transplant or those who are in the waiting list for liver transplantation Participants who have received a live/attenuated vaccine within 30 days of randomization (eg, varicella, zoster, yellow fever, rotavirus, oral polio and measles, mumps, rubella [MMR]). Other protocol defined inclusion/exclusion criteria apply

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br> | Biological: Nivolumab<br>* Specified dose on specified days<br>* Other names: BMS-936558;|
| Placebo Comparator: Arm B<br> | Other: Placebo<br>* specified dose on specified days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence-free Survival (RFS) |  | Up to 49 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) |  | Up to 7 years | 
| Time to recurrence (TTR) |  | Up to 49 months |
Intra-abdominal Hypertension in Critically Ill Patients

Study Overview
=================
Brief Summary
-----------------
The aim of the proposed study is to determine the incidence and prevalence of intra-abdominal hypertension and abdominal compartment syndrome in consecutive intensive care admissions using broad inclusion criteria.

Detailed Description
-----------------
Increased pressure within the abdominal cavity is particularly common in intensive care patients and has been shown to be an independent risk-factor for mortality in this patient population. The quoted rates of intra-abdominal hypertension of range anywhere from 20-60% are dependent on the population of patient studied. The prospective observational studies performed to date have been underpowered, used strict inclusion/exclusion criteria or were performed prior to consensus guidelines on the definition and measurement of intra-abdominal pressure and hypertension.

Official Title
-----------------
Intra-abdominal Hypertension in Critically Ill Patients

Conditions
-----------------
Intra-Abdominal Hypertension, Abdominal Compartment Syndrome

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Foley catheter in-situ on admission Exclusion Criteria: Contra-indication to bladder pressure measurement Home service asked that patient is not included Death within 24 priors of admission before bladder pressure measured No bladder pressure performed within 24 hours of admission Consent refused or unable to be obtained (lack of SDM, patient unable to provide)

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 |
| --- | --- |
| Elevated Intra-abdominal Pressure<br>Patients with intra-abdominal pressure > 12 mmHg at any time throughout admission | Other: No intervention<br> <br> |
| Normal Intra-abdominal Pressure<br>Patients with intra-abdominal pressure < 12 mmHg throughout admission | Other: No intervention<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | As measured prospectively by patient death in the ICU | While patient in-hospital, expected stay one week on average | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay | Measured prospectively from date of admission to ICU to death, or discharge from ICU | While patient in-hospital, expected stay one week on average | 
| Abdominal decompression | Midline laparotomy for abdominal compartment syndrome | While patient in-hospital, expected stay one week on average |
Acute Effect of HMG-CoA Reductase Inhibition (Atorvastatin)on Renal Hemodynamics, Tubular Function and Vasoactive Hormones on Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
We wanted to test the acute effect of HMG-CoA reductase inhibition (atorvastatin) on renal hemodynamics, renal tubular function and vasoactive hormones on healthy subjects.

Official Title
-----------------
Acute Effect of HMG-CoA Reductase Inhibition (Atorvastatin)on Renal Hemodynamics, Tubular Function and Vasoactive Hormones on Healthy Subjects

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

Intervention / Treatment
-----------------
* Drug: HMG-CoA reductase inhibition (atorvastatin)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Both men and women Age: Between 20-50 BMI<30 Exclusion Criteria: Clinical signs or history of disease of heart, lungs, kidneys or endocrine organs. Abnormal lab. tests( haemoglobin, pl. sodium, pl. potassium, pl.creatinine, pl.bilirubin, pl.ALAT, pl. cholesterol, blood glucose) Albuminuria or glucosuria Cancer Art. hypertension Alcohol abuse Medical treatment, except oral contraceptives Pregnancy or breast feeding Blood donation less than 1 month before study

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: HMG-CoA reductase inhibition (atorvastatin)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GFR |  |  | 
| RPF |  |  | 
| FEna |  |  | 
| FELi |  |  | 
| CLna |  |  | 
| CLli |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HMG-COA reductase inhibition, GFR, RPF, FE, CL
Retrospective Trial on Low Prognosis Infertile Patients

Study Overview
=================
Brief Summary
-----------------
The main objective of this study is to analyze management of Controlled Ovarian Stimulation (COS) protocols in low prognosis patients, secondly to observe the clinical outcomes (Fertilization Rate, Pregnancy Rate, the Ongoing Pregnancy Rate and the Live birth Rate) and the total units of gonadotrophins consume per M2 oocyte retrieved in this subgroup.

Detailed Description
-----------------
Humanitas Fertility Center maintains an external audit anonymized electronic research queries system, exported from a certified only access web database, which at time of this analysis (cycles at December 31th 2016) include 26,883 consecutive fresh non-donors IVF cycles. Patients who underwent these cycles had consented in writing that their medical records could be used for research purposes, as long as the patients' anonymity was protected and confidentiality of the medical record was assured. Since both of these conditions were met, this study has been approved on March 2th 2017 with an expedited review and approval protocol by the center's Institutional Review Board (IRB). At least 2,000 expected low prognosis patients in the Humanitas Fertility Center Database out of 12,545 cycles performed in the period 2010-2015 with completed pregnancy follow-up.

Official Title
-----------------
An Observational Retrospective Cohort Trial on Low Prognosis Infertile Patient's Accessing IVF Cycle Management

Conditions
-----------------
Infertility, Female, Fertility Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≤ 44 Body Mass Index; 18 ≤ BMI ≥ 27 Number of oocytes retrieved ≤ 9 Cycles performed between January 2010 - December 2015 Exclusion Criteria: Age > 44 Number of oocytes retrieved ≥ 10 Abnormal uterine cavity Endometriosis III-IV stage or adenomyosis Testicular spermatozoa PGS (Preimplantation Genetic Screening) cycles

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 44 Years

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

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 |
| --- | --- | --- |
| induction protocol type | number of antagonist and agonist protocols/ total numbers | 6 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fertilization Rate | fertilized oocytes/ number of oocytes used | 6 years | 
| Pregnancy Rate | number of gestational sacs/ number of embryos transferred | 6 years | 
| Ongoing Pregnancy Rate | number of pregnancy > 20 weeks/ total pregnancies | 6 years | 
| Live Birth Rate | number babies born/ total pregnancies | 6 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
low responders
Ketoprofen With or Without Vaginal Isonicotinic Acid Hydrazide Prior to Hysterosalpingography

Study Overview
=================
Brief Summary
-----------------
The aim of our study is to determine the efficacy of Ketoprofen with or without vaginal isonicotinic acid hydrazide on the pain scores during HSG.

Detailed Description
-----------------
hysterosalpingography can cause pain and discomfort in several ways: Use of the tenaculum to grasp the cervix and straighten the uterus for proper insertion; trans-cervical actions including measuring uterine depth, inserting the cannula; and injection of the dye

Official Title
-----------------
Ketoprofen With or Without Vaginal Isonicotinic Acid Hydrazide (INH) Prior to Hysterosalpingography in Primarily Infertile Patients: a Randomized Controlled Trial

Conditions
-----------------
Infertility, Female

Intervention / Treatment
-----------------
* Drug: Ketoprofen + INH
* Drug: Ketoprofen + placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: any patient came for Hysterosalpingography Exclusion Criteria: any patient has contraindication to HSG

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

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: double blind placebo randomized controlled trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>patients will have of oral Ketoprofen 60 minutes before the procedure plus 3 table 900 mg vaginal isonicotinic acid hydrazide by the patient 12 hours before the procedure | Drug: Ketoprofen + INH<br>* patients will have of oral Ketoprofen 60 minutes before the procedure plus 3 table 900 mg vaginal isonicotinic acid hydrazide by the patient 12 hours before the procedure<br>|
| Placebo Comparator: Group B<br>patients will have of oral Ketoprofen 60 minutes before the procedure plus 3 table vaginal placebo by the patient 12 hours before the procedure | Drug: Ketoprofen + placebo<br>* patients will have of oral Ketoprofen 60 minutes before the procedure plus 3 table placebo by the patient 12 hours before the procedure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensity of pain | pain during the procedure assessed by the visual analog scale from 0=no pain to 10 = the worst pain imaginable | 15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensity of pain | Pain intensity will be assessed by visual analogue scale 30 minutes after the procedure.visual analogue scale ranging from 0 to 10 | 30 minutes after the procedure |
Bioequivalency Study of Famciclovir 500 mg Tablets Under Fasted Conditions

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to prove the bioequivalence of Famciclovir 500 mg Tablets under fasting conditions.

Official Title
-----------------
A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Famciclovir Tablets Under Fasting Conditions

Conditions
-----------------
Herpes

Intervention / Treatment
-----------------
* Drug: famciclovir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening Exclusion Criteria: Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to famciclovir, penciclovir or any comparable or similar product.

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: famciclovir|500 mg tablet|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bioequivalence determined by statistical comparison Cmax |  | 8 days |
Pharmacological Properties of Salmeterol

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to help establish a urinary threshold for salmeterol on the World Anti-doping Agency prohibited list, to avoid supratherapeutic of this substance in competitive sports. Hence, there is no hypothesis as such.

Official Title
-----------------
Pharmacological Properties of Inhaled Salmeterol in Healthy Trained Males

Conditions
-----------------
Pharmacokinetics in Healthy Young Men

Intervention / Treatment
-----------------
* Drug: Salmeterol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male 18-45 years Healthy Exclusion Criteria: Chronic disease Smoking Habitual use of medicine Allergy towards salmeterol Unable to exercise on a bike ergometer

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: salmeterol<br> | Drug: Salmeterol<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urine concentration of salmeterol |  | 0-24 hours after administration of the study drug | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
salmeterol, pharmacokinetics, doping, beta2-agonists, long-acting beta2-agonists
Spiriva® in Patients With Chronic Obstructive Pulmonary Disease (COPD) in Daily Practice

Study Overview
=================
Brief Summary
-----------------
Post-marketing surveillance to gather information regarding the tolerance and efficacy of Spiriva® 18 micrograms in patients with COPD under conditions of daily practice.

Official Title
-----------------
Tolerability and Efficacy of Spiriva® 18 Micrograms in Patients With COPD in Daily Practice

Conditions
-----------------
Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
-----------------
* Drug: Tiotropium bromide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women aged at least 40 years with the symptoms of Chronic Obstructive Pulmonary Disease Exclusion Criteria: Patients with the general and specific contraindications listed in the Patient Information Leaflet and the Basic Product Information

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- |
| Symptoms of COPD<br>Patients with symptoms of COPD receiving Tiotropium bromide 18 micrograms | Drug: Tiotropium bromide<br>* Tiotropium bromide 18 micrograms<br>* Other names: Spiriva®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in breathlessness when walking/climbing stairs |  | Baseline, after 4 weeks | 
| Change from baseline in breathlessness on physical exercise |  | Baseline, after 4 weeks | 
| Change from baseline in breathlessness during everyday activities |  | Baseline, after 4 weeks | 
| Change from baseline in breathlessness during housework |  | Baseline, after 4 weeks | 
| Change from baseline in overall severity of the clinical picture |  | Baseline, after 4 weeks | 
| Occurrence of Adverse Events |  | 4 weeks |