linjc16/ctgov huggingface dataset:
Bioequivalency Study of Mycophenolate Mofetil 500 mg Tablets Under Fasted Conditions

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to prove the bioequivalence of Mycophenolate Mofetil 500 mg tablets under fasted conditions.

Official Title
-----------------
A Single Dose, 2-Period, 2-Treatment 2-Way Crossover Bioequivalency Study of Mycophenolate Mofetil 500 mg Tablets Under Fasting Conditions

Conditions
-----------------
Prophylaxis of Organ Rejection

Intervention / Treatment
-----------------
* Drug: Mycophenolate Mofetil


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 mycophenolate mofetil 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: Mycophenolate Mofetil|Mycophenolate Mofetil 500 mg Tablet|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bioequivalence determined by statistical comparison Cmax |  | baseline, 2-period, 14 day washout |
Cross-Sectional Study: Prevalence of Restless Legs Syndrome in Patients With Unpleasant Sensations of the Legs

Study Overview
=================
Brief Summary
-----------------
The proposed study is a Cross-sectional epidemiological study, performed in 330 primary care practices in Germany. The study will be conducted on a fixed day in November 2007. Primary care surgeries throughout Germany will be asked to take part. The study material will be delivered to the surgery by a member of sales-force who will also explain the study conduct to the physician/staff. Physicians who want to take part in the study will send a signed contract to BI. Physicians will be trained to diagnose RLS. All patients attending the participating surgeries on a fixed day will be invited to participate in the study. The patients will be handed a questionnaire to fill out while waiting for their appointment. No patient-related data apart from gender and year of birth will be recorded on the questionnaire and it will be ensured that no re-identification of patients is possible. Therefore, no written informed consent will be obtained from the participants. The patient questionnaire will consist of the following items: A screening questionnaire for RLS (according to Stiasny-Kolster et. al., data on file) Additional questions concerning the impact of the patients leg problems on daily life. The practice staff will then collect the questionnaire. All patients who have answered question 1 (asking for unpleasant sensations of the legs) with ¿Yes¿ will subsequently be assessed for the diagnosis by the physician. The physician fills out a second questionnaire, covering the following items: Diagnosis (cause of leg problems) Concomitant diagnoses and therapies If the diagnosis of RLS was made: consequences (therapy)? Was the diagnosis of RLS pre-known? All completed questionnaires will be sent to data management by the surgery within 2 working days.

Official Title
-----------------
Prevalence of Restless Legs Syndrome in Patients With Unpleasant Sensations of the Legs

Conditions
-----------------
Restless Legs Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients attending one of the participating primary care surgeries on a fixed day Male or female patients of any age Exclusion Criteria: Patients who only attend the practice to get a prescription and are not seen by the doctor on that day. Patients who are not able to understand the questionnaire due to mental impairment or language problems. Children and adolescents under the age of 18 years

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 |
| --- | --- | --- |
An Additional Confirmatory Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the superiority of KPS-0373 to placebo, and evaluate the safety of KPS-0373 in SCD patients.

Official Title
-----------------
An Additional Phase III Confirmatory Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)

Conditions
-----------------
Spinocerebellar Degeneration

Intervention / Treatment
-----------------
* Drug: KPS-0373
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Japanese SCD patients with mild to moderate ataxia Exclusion Criteria: Patients with secondary ataxia Patients with clinically significant hepatic, renal, or cardiovascular dysfunction

Ages Eligible for Study
-----------------
Minimum Age: 20 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: KPS-0373<br> | Drug: KPS-0373<br>* 24 weeks<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* 24 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SARA (Scale for the Assessment and Rating of Ataxia) | The change in the SARA total score at the time of final evaluation | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SF-8(QOL) |  | 24 weeks |
RESCUE PROTOCOL AND FRESH EMBRYO TRANSFER

Study Overview
=================
Brief Summary
-----------------
Ovarian Hyperstimulation Syndrome (OHSS) is one of the most dangerous complications of Assisted Reproductive Technologies (ART) cycles. The use in clinical practice of the GnRH antagonist has made it possible to perform the trigger with GnRH analogues reducing the risk of OHSS. The trigger with analogue increases the Abortion Rate (AR) and reduces the Ongoing Pregnancy Rate (OPR), because the luteal phase in these cycles is particularly deficient. To reduce this occurrence several studies have focused on the importance of support of the luteal phase. The aims of study is to evaluate OPR and AR in patients at intermediate risk of OHSS (<18 recovered oocytes) which performed GnRH trigger and rescue protocol.

Official Title
-----------------
RESCUE PROTOCOL AND FRESH EMBRYO TRANSFER AFTER TRIGGER WITH ANALOGS OF GNRH: THE HUMANITAS PROTOCOL

Conditions
-----------------
GnRH Trigger and Rescue Protocol

Intervention / Treatment
-----------------
* Drug: GnRH agonist


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: AMH ( antimullerian hormone) > 3.5 ng / ml, AFC (antral follicles count) > 15 follicles and if more than 18 follicles with diam. 12mm to induction Exclusion Criteria: high risk of OHSS ( ovarian hyperstimulation syndrome)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 38 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients underwent rescue protocols and fresh embryotransfer<br>they were patients with good prognosis with a mean age of 34.13 ± 4.42 years, with a good ovarian reserve | Drug: GnRH agonist<br>* In High Responder patients (HR) (more than 18 follicles with diameter ≥ 12mm at ovulation induction), the trigger was obtained with triptorelin 0.2 mg sc. In this cohort if less of 18 oocytes were retrieved, patients were considered at intermediate risk of OHSS and fresh transfer was performed. An adequate support of the luteal phase was initiated: HCG 1500 IU / sc the day of the pick up + estradiol 4 mg + vaginal progesterone 400 mg daily (Rescue protocol).<br>* Other names: GnRH trigger;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ongoing pregnancy rate (OPR) | presence of gestational sac and fetal hearts beats showed on unltrasonography 7/8 weeks after embryo transfer | 2013-2018 |
Evaluation of Buffer on Immune Response to Oral Polio Vaccine (OPV) in Bangladesh

Study Overview
=================
Brief Summary
-----------------
Hypothesis: The immunogenicity of oral polio vaccine (OPV) will be enhanced in Bangladeshi infants who receive bicarbonate buffer at the time of polio immunization.

Detailed Description
-----------------
The investigators will conduct a study to evaluate the impact of administering bicarbonate buffer on the serologic responses to oral polio vaccine (OPV) in Bangladeshi infants.

Official Title
-----------------
Evaluation of the Effect of Buffer on the Immune Response to Oral Poliovirus Vaccine in Bangladesh: a Randomized Controlled Trial

Conditions
-----------------
Polio

Intervention / Treatment
-----------------
* Other: Buffer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: infants who are 4-8 weeks old residents of study area Exclusion Criteria: received a blood transfusion or any other blood product (such as immune globulin) likely to move out of study area within the next four months currently enrolled or planning to enroll in another study major congenital malformations neurologic disorders immunodeficiency

Ages Eligible for Study
-----------------
Minimum Age: 4 Weeks
Maximum Age: 8 Weeks

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Buffer<br> | Other: Buffer<br>* 5 ml of oral buffer solution containing 64 mg of sodium bicarbonate plus 24 mg of sodium citrate. The buffer will be administered prior to each dose of OPV at 6, 10 and 14 weeks of age.<br>|
| No Intervention: Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serologic response | Serologic response rate for each polio virus serotype (1, 2, and 3) in OPV. | 4 weeks after last dose of OPV |
Level of Knowledge and Habitual Concepts of Turkish Parents on Child Passenger Safety

Study Overview
=================
Brief Summary
-----------------
It is well known that traffic accidents are one of the major reasons for death in childhood. Unfortunately scientific and statistical data usually comes from developed countries. In this study, the investigators will try to evaluate Turkish families' knowledge on Child Passenger Safety, observe how they carry their babies in the car and investigated the reasons behind the undesired behaviors.

Official Title
-----------------
Too Small for a Car Seat. An Unnoticed Obstacle to the Proper Use of Car Seats!

Conditions
-----------------
Equipment Safety, Accidents, Traffic

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All families Exclusion Criteria: Families with premature or neurologically disabled babies.

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Mother<br>study objectives to Mother only | |
| Father<br>study objectives to Father only | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| test score | test score that measures the level of knowledge on child passenger safety by a 10 item questionnaire | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of families using car seats properly | I will be evaluated in 4 categories: Connecting the baby to the car seat properly, Connecting the car seat to the car properly, Using the rear facing, Placing the car seat to the center rear of the car. | baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Child Passenger Safety, Parental perception of vulnerability, Neonatology, Newborn
Retrospective Multicentre Observational Study on the Incidence of Hyperoxia in Non-intubated Patients in Intensive Care in Belgium Study OxSIZgen

Study Overview
=================
Brief Summary
-----------------
Oxygen is the most widely prescribed therapy in the ICU (intensive care unit) and can save lives in critical patients. While the deleterious effects of hypoxia are apparent and must be actively avoided, hyperoxia also has adverse effects. These include systemic, coronary and cerebral vasoconstriction; decreased coronary blood flow; pulmonary atelectasis and increased free radicals. Despite these deleterious effects, hyperoxia is common and frequent in the ICU (from 22% to 74%). A recent meta-analysis published in The Lancet with more than 16,000 patients demonstrated an association between liberal oxygen therapy and mortality in critical patients. Other meta-analyses confirm its results with high quality data according to the authors. A randomized controlled trial published in The New England Journal of Medicine comparing liberal versus conservative oxygen therapy showed no difference in mechanical ventilation days and mortality (The ICU-ROX, 2019). However, the difference in PaO2 between the two groups was very small and the PaO2 in the liberal group did not exceed 100 mmHg. In any case, conservative oxygen therapy is safe for critical patients. The recommendations therefore recommend an oxygen saturation between 94-97% in critical patients and 88-92% in patients with COPD (Chronic Obstructive Pulmonary Disease) . However, to our knowledge, no study has described the incidence of hyperoxia in non-intubated patients in the intensive care unit.

Official Title
-----------------
Prospective Multicentre Observational Study on the Incidence of Hyperoxia in Non-intubated Patients in Intensive Care in Belgium Study OxSIZgen

Conditions
-----------------
Hyperoxia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient having oxygen Not to be ventilated Being over 18 years old Exclusion Criteria: Sickle cell disease patient Patient with pneumo/hemothorax Pregnant women, prisoners, denial of informed consent Patients who are related to an investigator Patients undergoing hyperbaric chamber therapy Patients with CO Patients on ECMO Patients with paracoate poisoning... Patients included in other interventional studies

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| INTENSIVE CARE UNITS<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| INCIDENCE HYPEROXIA |  | one week |
Stellarex Vascular E-Registry

Study Overview
=================
Brief Summary
-----------------
Prospective, international, multi-center, single arm, observational study to continue to assess the treatment by the Stellarex™ OTW Drug-coated Angioplasty Balloon in superficial femoral and/or popliteal arteries according to the Instructions for Use in a broad, real-world, claudicant or ischemic rest pain patients population per the institution's standard practice.

Official Title
-----------------
Stellarex Vascular E-Registry

Conditions
-----------------
Peripheral Arterial Disease

Intervention / Treatment
-----------------
* Device: Percutaneous Transluminal Angioplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients intended to be treated with Stellarex for de-novo or restenotic lesions of the femoro-popliteal arteries Rutherford Clinical Category (RCC) 2-3 or 4 indicated for a Percutaneous Transluminal Angioplasty according to local applicable guidelines Age ≥18 years old Life expectancy > 1 year Is able and willing to provide written informed consent prior to enrollment in the study (as applicable) Is able and willing to come on site or to be contacted by phone for the follow-up Exclusion Criteria: Patients with any medical condition that would make him/her inappropriate for treatment with Stellarex as per Instructions for Use (IFU) or investigator's opinion Patient already enrolled in other investigational (interventional) studies that would interfere with study endpoints Patients that in the judgment of the investigator would need treatment below the knee before and/or during the index procedure.

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 |
| --- |
|Device: Percutaneous Transluminal Angioplasty|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Efficacy Endpoint | Freedom from Clinically Driven Target Lesion Revascularization | 12 months post-procedure | 
| Primary Safety Endpoint | Freedom from device and procedure-related death through 30 days post-procedure and freedom from target limb major amputation and Clinically Driven Target Lesion Revascularization through 12 months post-procedure | 12 months post-procedure |
Osteoarticular Infections With Pneumococcal

Study Overview
=================
Brief Summary
-----------------
Osteoarticular infections at pneumococcal are rare, potentially serious and remain under diagnosed. They represent 3 at 10% of the arthritis septic in the literature. 190 cases have been published of 1965 at 2003. They represent 0.3% at 0.6% of the bacteraemia at Streptococcus peumoniae.

Official Title
-----------------
Osteoarticular Infections With Pneumococcal

Conditions
-----------------
Bone and Joint Infection

Intervention / Treatment
-----------------
* Other: Bone and joint infection with Streptococcus peumoniae


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients having had a bone and joint infection with S pneumoniae, with or without device. Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Bone and joint infection with Streptococcus peumoniae<br>Patients having had an osteoarticular infection with Streptococcus peumoniae | Other: Bone and joint infection with Streptococcus peumoniae<br>* description of the osteoarticular infection with Streptococcus peumoniae<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description and rate of bone or joint infection with S. pneumoniae | Description of the type of infection due to S. pneumoniae : patients and type of implant, profile of the bacterium associated in the infection, medical and chirurgical treatment | Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Treatment Failure | Treatment failure is defined by local clinical and/or microbiological relapse; and/or need for additional surgery; death of septic origin | Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bone and Joint Infection, Streptococcus peumoniae
Expanded Access to Cefiderocol for the Intravenous Treatment of Severe Gram Negative Bacterial Infections

Study Overview
=================
Brief Summary
-----------------
Expanded access may be provided for cefiderocol for qualified patients who have limited treatment options and are not eligible for a clinical trial.

Official Title
-----------------
Expanded Access to Cefiderocol for the Intravenous Treatment of Severe Gram Negative Bacterial Infections

Conditions
-----------------
Bacterial Infections

Intervention / Treatment
-----------------
* Drug: Cefiderocol


Participation Criteria
=================
Eligibility Criteria
-----------------
Hospitalized patients with serious Gram-negative bacterial infections and who have limited treatment options and are not eligible for a clinical trial.
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Cefiderocol|Cefiderocol for intravenous infusion|

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
-----------------
S-649266, cefiderocol, Gram-negative