linjc16/ctgov huggingface dataset:
A Prospective Randomized Multicentre Study to Compare Crinone 8% Once Daily Versus Other Vaginal Progesterone.

Study Overview
=================
Brief Summary
-----------------
To compare the effect of Crinone 8% administered once daily versus other vaginal progesterone in terms of ongoing pregnancy rate 5 weeks after embryo transfer as well as patient convenience.

Official Title
-----------------
A Prospective Randomized Multicentre Study to Compare Crinone 8% Once Daily Versus Other Vaginal Progesterone.

Conditions
-----------------
IVF - Luteal Phase Support After Embryo Transfer

Intervention / Treatment
-----------------
* Drug: progesterone
* Drug: Progesterone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-40 years Regular menstrual cyclus 25-35 days both ovaries present No more than 2 previous IVF attempts Have given written informed consent Exclusion Criteria: More than 2 previous attempts Known drug abuse Known allergies to the study medication No embryo transfer performed in the study cycle Previous participating in the study

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Crinone vaginal gel 8% 90 mg once daily | Drug: progesterone<br>* 90 mg, vaginal, once daily<br>* Other names: crinone 8%;|
| Active Comparator: 2<br>Progesterone mic 400 mg three times daily | Drug: Progesterone<br>* 200 mg, vaginal, three times daily used in Denmark, 400 mg, vaginal, three times daily used in Sweden<br>* Other names: Progesterone mic in Sweden;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Equivalence in ongoing pregnancy per embryo transfer between the two groups |  | week 5 after embryo tranfer | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Convenience for the patient |  | the treatment period (from the day of embryo transfer and 19 days ahead) |
Fluid Balance During Closure of Atrial Septal Defect

Study Overview
=================
Brief Summary
-----------------
This project will evaluate fluid balance and oedema formation in children with the same congenital heart disease (Atrial Septal Defect) who will either go through heart surgery with the use of Cardio Pulmonary Bypass and hypothermia or through interventional catheterization. The investigators will measure interstitial colloid osmotic pressure, distribution of proteins and cytokines. The study hypothesis is that Oedema developed during heart surgery is caused by reduced colloid osmotic pressure gradient through the capillary membrane.

Official Title
-----------------
Protein Distribution and Colloid Osmotic Pressure in Children With Volume and Pressure Loading Due to Congenital Heart Defects

Conditions
-----------------
Heart Defects,Congenital, Heart Septal Defects, Atrial

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The diagnosis of Atrial Septal Defect scheduled for closure Informed consent Exclusion Criteria: Renal failure, liver failure, coexisting cardiac malformations

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 10 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 |
| --- | --- |
| Interventional closure<br>Interventional catheterization closure | |
| Open Heart Surgery<br>Surgery for Atrial septal defect | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interstitial colloid osmotic pressure |  | During surgery or interventional closure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart Septal Defects, Atrial, Oedema formation
A Trial Of SU14813 In Patients With Advanced Solid Malignancies

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to define the Maximum tolerated dose of SU14813 when administered as single agent in patients with solid tumors.

Official Title
-----------------
A Phase I Dose Escalating Study Of SU014813 In Patients With Solid Tumors Not Amenable To Conventional Therapy

Conditions
-----------------
Neoplasms, Solid Tumors

Intervention / Treatment
-----------------
* Drug: SU014813


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a histologically proven advanced solid malignancy for which no recognized therapy was available or for which standard therapy had failed Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Serum albumin ≥3.0 g/dL and adequate haemopoietic, renal and liver function Exclusion Criteria: Chemotherapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C) or radiotherapy or an investigational agent within 4 weeks before the start of study treatment Subjects had to have recovered from all prior treatment toxicities, except alopecia, and from any major surgery.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SU014813<br> | Drug: SU014813<br>* Escalating doses of SU014813 from 50 to 250mg/day . Capsules administered daily either as continuous dosing or in cycles of 4 weeks on 1 week off<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Tolerated Dose (MTD) |  | 18-Nov-2008 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the recommended Phase 2 dose (RP2D) |  | 18-Nov-2008 | 
| Preliminary information on SU014813 anti-tumor effect; |  | 18-Nov-2008 | 
| Plasma pharmacokinetics |  | 18-Nov-2008 | 
| Plasma targets such as vascular endothelial growth factor (VEGF), soluble VEGF-R2 and soluble KITa |  | 18-Nov-2008 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cancer
Regenerex Tibial Tray Multi-Center Data Collection

Study Overview
=================
Brief Summary
-----------------
The purpose of this prospective clinical data collection is to document the performance and clinical outcomes of the Regenerex™ Tibial Tray.

Detailed Description
-----------------
See Protocol

Official Title
-----------------
Regenerex Tibial Tray Multi-Center Data Collection

Conditions
-----------------
Pain, Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The inclusion criteria will be identical to the indications stated in the FDA approved labeling for the device (cleared in 510(k) K080361. These indications are stated below: Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. Correction of varus, valgus, or posttraumatic deformity. Correction or revision of unsuccessful osteotomy, or arthrodesis. Patient selection factors to be considered include: Ability and willingness of the patient to follow instructions, including control of weight and activity level A good nutritional state of the patient, and The patient must have reached full skeletal maturity Exclusion Criteria: The exclusion criteria will be identical to the contraindications stated in the FDA approved labeling for the device (cleared in 510(k) K080361. These contraindications are stated below: Absolute contraindications include: infection, sepsis, osteomyelitis, and failure of a previous joint replacement. Relative contraindications include: Uncooperative patient or patient with neurologic disorders who are incapable of following directions, Osteoporosis, Metabolic disorders which may impair bone formation, Osteomalacia, Distant foci of infections which may spread to the implant site, Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram, Vascular insufficiency, muscular atrophy, neuromuscular disease, Incomplete or deficient soft tissue surrounding the knee.

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 |
| --- | --- | --- |
| Knee Society Score |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survivorship |  | 5 years/ patient | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Press fit tibial tray
Study Evaluating the Effects of MOA-728 on Cardiac Repolarization in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to assess the effects of MOA-728 on cardiac repolarization in healthy subjects.

Official Title
-----------------
A Randomized, Double-Blind, Placebo- and Moxifloxacin (Open-Label)-Controlled, 4-Period Crossover Study of the Effects of a Single Dose of MOA-728 Infused Intravenously on Cardiac Repolarization in Healthy Subjects

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

Intervention / Treatment
-----------------
* Drug: MOA-728


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Generally healthy subjects men or women aged 18-50 Exclusion Criteria: Any significant clinically important disease Family history of long QT syndrome and/or sudden cardiac death Allergy to moxifloxacin or the quinolone class of antibiotics

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

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MOA-728|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac repolarization will be assessed by the QTc interval in healthy subjects. |  |  |
A Trial of Heparin in Patients With Severe Sepsis Who Are Undergoing Treatment With Drotrecogin Alfa (Activated)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the relative efficacy and safety of prophylactic heparin co-administration during drotrecogin alfa (activated) infusion in the treatment of severe sepsis in the adult.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled Trial of Prophylactic Heparin in Patients With Severe Sepsis and Higher Disease Severity Who Are Undergoing Treatment With Drotrecogin Alfa (Activated)

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

Intervention / Treatment
-----------------
* Drug: Drotrecogin Alfa (Activated)
* Drug: Unfractionated heparin
* Drug: Low molecular weight heparin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Adults greater than or equal to 18 years of age Receiving inpatient treatment for severe sepsis Indicated for treatment with Drotrecogin Alfa (Activated) under approved label in the country where the patient is enrolled Exclusion Criteria Contraindicated for heparin treatment Require a higher dose of heparin than defined in the trial Have acute or chronic renal failure with an estimated creatinine clearance less than 30mL/min Weigh more than 135 kg (297 pounds) Are not expected to survive 28 days given their medical condition.

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

| Intervention/Treatment |
| --- |
|Drug: Drotrecogin Alfa (Activated)|nan|
|Drug: Unfractionated heparin|nan|
|Drug: Low molecular weight heparin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demonstrate in adult patients with severe sepsis who are receiving drotrecogin alfa (activated) that concomitant treatment with heparin is equivalent to treatment with placebo as determined by 28-day all-cause mortality. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the incidence of venous thrombotic events in patients receiving heparin vs. placebo through study days 6 |  |  | 
| and 28. Evaluate the safety profile of drotrecogin alfa (activated) and prophylactic heparin co administration by the incidence of intracranial hemorrhage and other serious bleeding events through study day 28. |  |  |
Effect of Stablor on Visceral Fat Loss in Patients With a Metabolic Syndrome

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the impact of the intake of a dietary supplement STABLOR™ on the change of the abdominal visceral fat mass in patients with a metabolic syndrome.

Official Title
-----------------
A Randomized Double-blind Placebo Controlled Trial on the Effect of Stablor™ on the Abdominal Visceral Fat Mass Loss in Patients With a Metabolic Syndrome

Conditions
-----------------
Metabolic Syndrome

Intervention / Treatment
-----------------
* Dietary Supplement: Stablor
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: With a Body Mass Index (BMI) more than or equal to 25 kg/m² and less than 40 kg/m², With a metabolic syndrome characterized by a a waist circumference of more than 94 cm for the males (90 cm for South-Asians, Chinese and Japanese) and more than 80 cm for the females, and at least 2 of the following criteria : Arterial Blood pressure > or = 130 mmHg (systolic) and/or more than or equal to 85 mmHg (diastolic) or stabilized with treatment for at least 6 months, Fasting glycemia > or = 1 g/L or 5.6 mmol/L or stabilized with treatment for at least 6 months and non-diabetic < 1.26 g/L, Triglycerides > or = 1.5 g/L or 1.71 mmol/L or stabilized with treatment for at least 6 months, HDL Cholesterol <0.40 g/L or 1.03 mmol/L (males) and <0,5 g/l or 1.29 mmol/L (females) or stabilized with treatment for at least 6 months. Exclusion Criteria: Pregnant (positive pregnancy test at the selection visit or breast-feeding woman, Woman of childbearing potential without an efficient contraception method, The above information is not intended to contain all considerations relevant to a patient's potential participation in the clinical trial

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Stablor<br>dietary supplement Stablor | Dietary Supplement: Stablor<br> <br> |
| Placebo Comparator: Placebo<br>dietary supplement Placebo | Dietary Supplement: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in visceral fat area assessed by computerized tomodensitometry |  | From baseline to Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in selected cardiometabolic risk factors : anthropometric and physical measurements, biomarkers |  | from baseline to end of study | 
| Quality of life, psychological and behavioral changes |  | From baseline to end of study |
Observational Study Evaluating the Safety of NovoMix® in Type 2 Diabetes Patients Previously Treated With a Human Premix Insulin

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Europe. The objective of this observational study is to evaluate the number of serious side effects, when initiating NovoMix® treatment in patients with type 2 diabetes who previously used a human premix insulin under normal clinical practice

Official Title
-----------------
Observational Study Evaluating Safety in Patients With Type 2 Diabetes Treated With NovoMix® 30 or NovoMix® 50 or NovoMix®70 (Biphasic Insulin Aspart)

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

Intervention / Treatment
-----------------
* Drug: biphasic insulin aspart 30
* Drug: biphasic insulin aspart 50
* Drug: biphasic insulin aspart 70


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes mellitus Exclusion Criteria: Known or suspected allergy to study product or related products. Pregnancy or breastfeeding or intention of becoming pregnant within the next 6 months.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br> | Drug: biphasic insulin aspart 30<br>* Start dose and frequency and safety data collection at the discretion of the physician following clinical practice<br>* Other names: BIAsp;Drug: biphasic insulin aspart 50<br>* Start dose and frequency and safety data collection at the discretion of the physician following clinical practice<br>Drug: biphasic insulin aspart 70<br>* Start dose and frequency and safety data collection at the discretion of the physician following clinical practice<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of serious adverse drug reactions, including major hypoglycaemic episodes, reported during the study period. |  | At baseline, 12 and 26 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of all hypoglycaemic episodes. |  | At baseline, 12 and 26 weeks. | 
| Number of all adverse drug reactions. |  | At baseline, 12 and 26 weeks. | 
| HbA1c |  | at 12 and 26 weeks | 
| Evaluation of fasting plasma glucose (FPG) values and postprandial glucose (PPG) levels |  | at 12 and 26 weeks | 
| Weight changes |  | at 12 and 26 weeks |
Phase I/II Cancer Caregiver Interventions to Improve Quality of Life and Prevent Burnout

Study Overview
=================
Brief Summary
-----------------
This study defines cancer caregivers as unpaid individuals who provide physical, practical, and/or emotional care and support to the cancer patient in the home setting. They may participate in this study if care recipients and the caregiver are both adults (18 years or older), with the patient having been diagnosed with cancer.The 8 intervention sessions will target the five domains of Quality Of Life (emotional, physical, social, cognitive, and spiritual well-being), be provided in group settings, and be delivered in two 45-minute sessions each week over a 4-week period.

Conditions
-----------------
Cancer Care Recipient

Intervention / Treatment
-----------------
* Other: Quality of Life Questionairre and Education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ability to provide written informed consent. Ability to speak, read, write and understand English language Has cancer caregiver status defined as an unpaid individual who provides physical, practical, and/or emotional care and support to a cancer care recipient in the home or other healthcare setting. Has a care recipient: ≥ 18 years of age who has a malignancy (either solid tumor or hematologic) diagnosis. who has signed a research authorization form who is undergoing or in the last 6 months has undergone cancer treatment Ability to use and access to a computer, tablet or other device with internet access and video capabilities Exclusion Criteria: Diagnosis within the past 12 months of active substance abuse (alcohol or drugs) Diagnosis within the past 12 months of active mental health condition that has required psychiatric hospitalization Diagnosis within the past 12 months of suicidal thoughts or attempt Care recipient is currently participating in another psychosocial clinical trial

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental arm<br> | Other: Quality of Life Questionairre and Education<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| calculate the average number of caregivers participating in each offered web-based session |  | 6 months |