linjc16/ctgov huggingface dataset:
A Single-Dose Study of MK6349 in Patients With Type 2 Diabetes (6349-002)

Study Overview
=================
Brief Summary
-----------------
A single dose study to assess the safety, tolerability, pharmacokinetics and pharmacokinetics of MK6349 in Type 2 Diabetics.

Official Title
-----------------
A Double-Blind, Randomized, Placebo-Controlled, Single and Divided Rising-Dose, Sequential Panel Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK6349 in Subjects With Type 2 Diabetes

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

Intervention / Treatment
-----------------
* Drug: MK6349
* Drug: Comparator: Placebo to MK6349


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is a non-smoking male or female (females must be postmenopausal, had a tubal ligation or a hysterectomy) between 18 to 55 years of age Subject has Type 2 Diabetes and is currently being treated with diet and exercise alone or with less than 3 oral diabetes drugs Exclusion Criteria: Subject is on insulin or a PPAR agonist medication Subject has Type 1 diabetes

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>MK6349 | Drug: MK6349<br>* Panel A: MK6349 in single doses beginning at 16 mg and rising to 90 mg in up to four treatment periods Panel B: MK6349 in single doses beginning at 90 mg and rising to 160 mg in up to four treatment periods Panel C: MK6349 in divided doses beginning at 20 mg q.a.c. (before each meal) and rising to 50 mg q.a.c. in up to four treatment periods<br>|
| Placebo Comparator: 2<br>Placebo to MK6349 | Drug: Comparator: Placebo to MK6349<br>* Panel A: Placebo to MK6349 in single doses in up to four treatment periods Panel B: Placebo to MK6349 in single doses in up to four treatment periods Panel C: MK6349 in divided doses q.a.c. (before each meal) in up to four treatment periods<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of MK6349 after single and divided rising doses based on assessment of clinical and laboratory evaluations and adverse experiences |  | Through 30 days after the last dose of study drug | 
| 15-Hour weighted mean plasma glucose (WMG) concentration |  | 15 hours postdose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 4-Hour weighted mean plasma glucose (WMG) concentration |  | 4 hours postdose |
Itch and Pain Characteristics in Skin Carcinomas

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to have better knowledge about sensations of patients with skin carcinomas and to have data about characteristics of pain and pruritus . All patients presenting with a suspicions lesion for skin carcinomas will be included and will respond to a questionnaire. Demographics data, and histological data about skin carcinomas will be collected.

Official Title
-----------------
Itch and Pain Characteristics in Skin Carcinomas

Conditions
-----------------
Skin Carcinoma, Skin Cancer, Pruritus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients with suspected skin carcinoma aged 18 years or more Exclusion Criteria: age under 18 years, inability to complete the questionnaire because of cognitive impairment

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate characteristics of pruritus in skin carcinomas | Questions about characteristics | Day1 (when presenting at consultation with a skin lesion suspicious for carcinoma) | 
| Evaluate characteristics of pruritus in skin carcinomas | Numerical visual scale (EVA) | Day1 (when presenting at consultation with a skin lesion suspicious for carcinoma | 
| Evaluate characteristics of pruritus in skin carcinomas | 5D-itch scale | Day1 (when presenting at consultation with a skin lesion suspicious for carcinoma | 
| Evaluate characteristics of pain in skin carcinomas | Numerical visual pain | Day1 (when presenting at consultation with a skin lesion suspicious for carcinoma | 
| Evaluate characteristics of in skin carcinomas | score DN4 | Day1 (when presenting at consultation with a skin lesion suspicious for carcinoma |
Oral Progesterone for Prevention of Preterm Birth

Study Overview
=================
Brief Summary
-----------------
To evaluate whether daily oral micronized progesterone is effective in preventing recurrent spontaneous preterm birth (RSPB) and whether micronized progesterone use increases maternal serum progesterone levels.

Detailed Description
-----------------
To evaluate whether 400 mg daily oral micronized progesterone from 16 to 34 weeks' is effective in preventing recurrent spontaneous preterm birth (RSPB) and whether micronized progesterone use increases maternal serum progesterone levels.

Official Title
-----------------
Prevention of Recurrent Preterm Birth With Micronized Progesterone

Conditions
-----------------
Preterm Birth

Intervention / Treatment
-----------------
* Drug: oral micronized progesterone
* Drug: Identical Placebo tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant women less than 20 weeks' gestation who had at least one prior spontaneous preterm birth of a liveborn baby between 20 & 0/7 weeks' and 36 & 6/7 weeks' gestation. Exclusion Criteria: multiple gestations, the presence of major fetal anomalies, progesterone use in the current pregnancy (ongoing or past), the presence of a cervical cerclage, and the presence of a placenta previa.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Progesterone Group<br>Oral Micronized Progesterone | Drug: oral micronized progesterone<br>* oral micronized progesterone = 400 mg oral micronized progesterone nightly from 16 to 34 weeks<br>* Other names: Prometrium(TM);|
| Placebo Comparator: Placebo<br>Identical Placebo Tablet | Drug: Identical Placebo tablet<br>* Identical Placebo tablet = placebo taking nightly from 16 to 34 weeks<br>* Other names: Placebo;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Recurrent Preterm Birth | Spontaneous preterm birth prior to 37 weeks' gestation. Indicated preterm deliveries (for maternal or fetal reasons) were excluded. | Prior to 37 weeks' gestation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Outcomes | Serum progesterone levels | Mean +/- Std Dev gestational age of 25.9/-2.4 weeks in Progesterone group, and 28.4 +/-4.7 weeks in placebo group | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Preterm birth, prevention, progesterone, oral
Effects of Renal Replacement Therapy With Hemoadsoption in Patients With Sepsis

Study Overview
=================
Brief Summary
-----------------
Hemoadsorption has been demonstrated to improve clinical and paraclinical results in critically ill patients with sepsis and septic shock. The present study investigates the effects of three consecutive sessions of hemoadsorption, performed in accordance to the local protocol for treating patients with sepsis, on organ failure, severity scores and 30-days mortality. Paraclinical results and severity scores were obtained before and after the three consecutive sessions.

Official Title
-----------------
Effects of Renal Replacement Therapy With Hemoadsoption in Patients With Sepsis

Conditions
-----------------
Sepsis

Intervention / Treatment
-----------------
* Procedure: CytoSorb


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with sepsis or septic shock who require hemoadsorption in accordance with local guidelines Exclusion Criteria: unsigned informed consent duration of therapy under 12 hours death before the three consecutive sessions

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: CytoSorb|three consecutive sessions of hemoadsorption in patients with sepsis|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28-days mortality | 28-days mortality | 28 days after ICU admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| severity score | dynamics of SOFA score (Sequential Organ Failure Assessment) calculated as the mathematical difference in post-therapy SOFA score and pre-therapy SOFA score | 3 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
organ failure, renal replacement therapy, hemoadsorption
Optimization of Initial Energy for Cardioversion of Atrial Fibrillation With Biphasic Shocks

Study Overview
=================
Brief Summary
-----------------
Use of higher energy doses (120-150 J) may not offer additional benefits and higher success rate compared with low to moderate initial energy (100-120 J) of biphasic shock for atrial fibrillation cardioversion. In this prospective open-label randomized trial consecutive patients with AF and candidate to AF electrical cardioversion will be randomized to receive 100J or 120 J as initial dose of biphasic shock. Patients will be also randomized in each group to anterolateral or postero-anteriore placement of defibrillator electrodes.

Detailed Description
-----------------
Open-label randomized trial to assess the efficacy of alternative initial biphasic shocks (100 versus 120 J) for cardioversion of atrial fibrillation including alternative option for electrode placement (anterolateral or postero-anterior in each group).

Official Title
-----------------
Optimization of Initial Energy for Cardioversion of Atrial Fibrillation With Biphasic Shocks (OPTIMA Trial).

Conditions
-----------------
Atrial Fibrillation, Cardioversion

Intervention / Treatment
-----------------
* Procedure: 100 joule as first biphasic shock energy
* Procedure: 120 joule as first biphasic shock energy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult (Age>18 years) Candidate to Cardioversion for recent onset, persistent atrial fibrillation (>48 hours but < 12 months) Informed Consent Exclusion Criteria: Atrial Flutter or other arrythmias

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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: 100 joule arm<br>100 joule as first biphasic shock energy | Procedure: 100 joule as first biphasic shock energy<br> <br> |
| Active Comparator: 120 joule arm<br>120 joule as first biphasic shock energy | Procedure: 120 joule as first biphasic shock energy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electrical cardioversion success |  | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electrical cardioversion success |  | 3 months | 
| Complications rate |  | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atrial Fibrillation, Cardioversion, Biphasic Shock
Prophylaxis Of Wound Infections- Antibiotics in Renal Donation

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to see whether antibiotics given at the start of laparoscopic kidney donation surgery prevent infection.

Detailed Description
-----------------
Subjects undergoing laparoscopic donor nephrectomy will be randomised to either a single dose of intravenous co-amoxiclav or placebo prior to surgery. Outcome measures include any infections, length of stay and costs

Official Title
-----------------
Are Prophylactic Antibiotics Necessary Before Laparoscopic Living Kidney Donation? A Double Blind, Randomised, Controlled Trial.

Conditions
-----------------
Infection

Intervention / Treatment
-----------------
* Drug: Co-Amoxiclav
* Drug: Normal Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All adult patients (over 18 years) undergoing hand-assisted laparoscopic donor nephrectomy, who have given written informed consent, will be included. Patients whose first language is not English will be included; they comprise a significant part of our patient population and we will use translation services as is our normal practice. Women of child-bearing age taking adequate contraception will be included. Exclusion Criteria: Patients with a known allergy to penicillin or other antibiotics. Patients with MRSA colonisation. Participation in another investigational study within the previous 90 days. Pregnant or breast-feeding women.

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drug: co-amoxiclav<br>experimental | Drug: Co-Amoxiclav<br>* Will receive 1.2g co-amoxiclav at induction<br>* Other names: Augmentin;|
| Placebo Comparator: Control<br>comparator | Drug: Normal Saline<br>* Placebo - 0.9% saline<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of infection after surgery |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ultrasonic evidence of wound healing | Wounds will be assessed using high resolution ultrasound to assess dermal and epidermal healing. | 24 months | 
| Length of hospital stay |  | 24 months | 
| Readmission rates |  | 24 months | 
| Antibiotic associated side effects | Including diarrhoea and allergic reactions | 24 months | 
| Return to work and normal activities |  | 24 months | 
| Quality of life |  | 24 months | 
| Relative costs |  | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Living donation, Antibiotics, Laparoscopic surgery
Cruciferous Vegetable Intake and Histone Status in Screening Colonoscopy Patients

Study Overview
=================
Brief Summary
-----------------
This research study will assess cruciferous vegetable intake in patients presenting for screening colonoscopy and correlate intake with histone status and histone deacetylace (HDAC) expression in tissue biopsy specimens and peripheral blood mononuclear cells (PBMCs). The investigators will also measure sulforaphane (SFN) metabolites in blood as a biomarker of cruciferous vegetable intake.

Official Title
-----------------
Cruciferous Vegetable Intake and Histone Status in Screening Colonoscopy Patients

Conditions
-----------------
Colon Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: scheduled for screening colonoscopy off NSAID or aspirin therapy in accordance with OHSU endoscopy clinic guidelines INR 0.90-1.20 hemoglobin ≥ 13.5 (men) or 12.0 (women) platelets ≥100,000/μL Chem screen results within normal limits negative (serum or urine) pregnancy test done ≤7 days prior to colonoscopy for women of childbearing potential only ASA performance status <2 Exclusion criteria: history of colon cancer or adenomatous polyps current smoker medical history of chronic obstructive pulmonary disease current oral steroid therapy current therapy with valproate or other pharmacological drugs associated with HDAC inhibition use of oral antibiotics within 3 months prior to entry into study significant active medical illness which in the opinion of the investigator would preclude collection/interpretation of colon tissue diagnosis of hemophilia, van Willebrand's disease or other bleeding disorder use of warfarin or other blood thinning agents inflammatory bowel disease.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 75 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 |
| --- | --- |
| Screening colonoscopy patients<br>Men and women age 50 to 75 scheduled for screening colonoscopy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cruciferous vegetable intake correlated with SFN and I3C urinary metabolites |  | At colonoscopy (day 1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cruciferous vegetable intake and p21 expression (qRT-PCR, ChIP in PBMCs) |  | at colonoscopy | 
| Cruciferous vegetable intake correlated with acetylated histone expression (PBMCs, colon tissue), |  | at colonoscopy | 
| Cruciferous vegetable intake correlated with HDAC activity (in PBMCs) |  | at colonoscopy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Colon cancer, Prevention, Cruciferous vegetables, Histone status
High Dose Methotrexate With Leucovorin Rescue With or Without Glucarpidase in Osteosarcoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate whether use of glucarpidase facilitates administration of the next cycle of chemotherapy as scheduled and improves safety and tolerability of HDMTX given with LV

Official Title
-----------------
Randomized, Blinded, Placebo-Controlled Trial of High Dose Methotrexate With Leucovorin Rescue (HDMTX-LV) With or Without Glucarpidase in Osteosarcoma

Conditions
-----------------
Osteosarcoma

Intervention / Treatment
-----------------
* Drug: glucarpidase
* Drug: leucovorin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: osteosarcoma eligible to receive 2 sequential cycles of HDMTX-LV Exclusion Criteria: prior administration of glucarpidase progression of disease while on previous MTX treatment

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>HDMTX-LV with glucarpidase | Drug: glucarpidase<br>* IV dose based on weight, two doses given for 5 minutes, 24 hours apart<br>* Other names: Voraxaze, caboxypeptidase G2, CPG2;|
| Active Comparator: B<br>HDMTX-LV with placebo | Drug: leucovorin<br>* IV or po given every 6 hours<br>* Other names: LV;|
| Experimental: C<br>compassionate use group to treat or prevent life threatening toxicity in the event of delayed elimination of MTX and/or renal impairment | Drug: glucarpidase<br>* IV dose based on weight, two doses given for 5 minutes, 24 hours apart<br>* Other names: Voraxaze, caboxypeptidase G2, CPG2;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients Progressing to Next Chemotherapy Cycle |  | 1 week after intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
osteosarcoma, high dose methotrexate, leucovorin
Study of Peripherally Inserted Central Catheter (PICC)-Related Infections in a Tropical Area

Study Overview
=================
Brief Summary
-----------------
Septi-PICC study aims at assessing incidence of Peripherally Inserted Central Catheter (PICC)-related infections among patients managed in the University Hospital of La Reunion for PICC setting.

Detailed Description
-----------------
Septi-PICC is a prospective single-center study of infections related to PICCs setting at the South tertiary site of the University Hospital of La Reunion over one year with a follow-up of 6 months per patient. All the complications such as thromboembolic, are collected during the follow-up. It is planned a convenience sample of 400 patients over 18 years of age, except pregnant women.

Official Title
-----------------
Suivi Prospectif Des Complications Infectieuses liées Aux PICC Lines en Milieu Tropical

Conditions
-----------------
Catheterization, Peripheral, Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients managed for a PICC setting in the tertiary care hospital Exclusion Criteria: known pregnancy minor

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of PICC-related infections |  | 1 year with 6 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of other complications following the PICC setting |  | 6 months follow-up | 
| Incidence of hospitalizations following the PICC setting |  | 6 months follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Peripherally Inserted Central Catheter, Infections, Radiology