linjc16/ctgov huggingface dataset:
Treatment of Patients With Major Depressive Disorder With MK0869 (0869-066)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
A clinical study to determine the efficacy and safety of an investigational medication (MK0869) in the treatment of depression

Detailed Description
-----------------
The duration of treatment is 1 year.

Official Title
-----------------
A Worldwide, Multicenter, Double-Blind, Parallel, Active-Controlled, Long-Term Safety Study of MK0869 in Outpatients With Major Depressive Disorder

Conditions
-----------------
Major Depressive Disorder

Intervention / Treatment
-----------------
* Drug: aprepitant
* Drug: Comparator: paroxetine HCL


Participation Criteria
=================
Eligibility Criteria
-----------------
Major Depressive Disorder

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: aprepitant|nan|
|Drug: Comparator: paroxetine HCL|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term safety and tolerability. |  | Duration of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sexual dysfunction adverse experiences and gastrointestinal disturbance adverse experiences |  | Duration of treatment |
Study of the Short-term Mortality and Morbidity of Newborns Born at a Gestational Age <32 Weeks of Amenorrhea

Study Overview
=================
Brief Summary
-----------------
An outborn birth is a premature birth that occurs in an unsuitable level center at the end of the child (unlike inborn births). This study aims to describe the morbidity and mortality of very premature newborns (gestational age less than 32 weeks of amenorrhea) born outside a maternity hospital of appropriate level between January 1, 2016 and December 31, 2020, and assessment of the preventable or non-preventable nature of these so-called outborn births. The aim of this research is to write down the short-term mortality and morbidity of newborns born at a gestational age <32 weeks of amenorrhea outside a level III maternity hospital in Alsace between January 1, 2016 and December 31, 2020.

Official Title
-----------------
Study of the Short-term Mortality and Morbidity of Newborns Born at a Gestational Age <32 Weeks of Amenorrhea Outside a Level III Maternity Hospital in Alsace

Conditions
-----------------
Premature Birth

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: - Newborn under 32 weeks of amenorrhea at the time of birth, born in Alsace in one of the level I, IIa, or IIb maternity hospitals, between January 1, 2016 and December 31, 2020 Exclusion criteria: - Fetal death in utero

Ages Eligible for Study
-----------------
Minimum Age: 32 Weeks

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 |
| --- | --- | --- |
| Study of the short-term mortality and morbidity of newborns born at a gestational age <32 weeks of amenorrhea |  | Files analysed retrospectively from January 01, 2016 to December 31, 2010 will be examined] | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Premature Birth, Outborn, Newborns, Gestational age
Spaced Retrieval as Treatment for Aphasia

Study Overview
=================
Brief Summary
-----------------
Spaced Repetition training has been found to be more effective than massed repetition for individuals with aphasia. This study seeks to examine the relative efficiency of three kinds of spacing for picture-naming training: traditional random presentation, non-adaptive spaced repetition, and adaptive spaced repetition.

Detailed Description
-----------------
Participants undergo a screening evaluation including the Quick Aphasia Battery (administered via teleconferencing software), and a preliminary picture naming test of approximately 300 pictures, used to select individual items for treatment. Participants then undertake online picture naming training for 30 minutes a day, over two weeks. Pictures are repeated according to three different schedules to be compared: random presentation, non-adaptive spaced repetition, and adaptive spaced repetition. We compare the number of pictures successfully learned and the verbal reaction time for the pictures assigned to the three conditions.

Official Title
-----------------
Spaced Retrieval as Treatment for Aphasia: Does Adaptive Spacing Enhance Picture Naming Performance?

Conditions
-----------------
Aphasia, Acquired, Aphasia Primary Progressive

Intervention / Treatment
-----------------
* Behavioral: Spaced Retrieval Practice


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: presence of a post-stroke word finding deficit (i.e. aphasia), or primary progressive aphasia. ability to evaluate the correctness of one's own responses when subsequently provided the with the correct answer Exclusion Criteria: diagnosis of a neurological disorder other than post-stroke or primary progressive aphasia inability to evaluate the correctness of ones responses when subsequently provided with the correct answer
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spaced Repetition<br>Two weeks (10 sessions) of online picture-naming training with 60 words. | Behavioral: Spaced Retrieval Practice<br>* Online picture-naming training with 60 words which the participant experiences word-retrieval difficulties. Cards are shuffled arranged by the computerized training program.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Picture Naming performance across conditions | Word retention assessed after treatment | Change from baseline to post-intervention immediately after two weeks of daily sessions, and one month followup. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adaptive Spaced-Retrieval, Aphasia, Anomia, Anki
Tranexamic Acid in Preventing Postpartum Hemorrhage in High Risk Pregnancies During Elective Cesarean Section

Study Overview
=================
Brief Summary
-----------------
postpartum hemorrhage (PPT) represents one of the major causes of maternal mortality . Tranexamic acid is used in many studies in management of PPH in combination with ecobolics. this study aims to evaluate the possible value of the use of tranexamic acid in prevention of postpartum hemorrhage .

Official Title
-----------------
The Effect of Tranexamic Acid in Preventing Postpartum Hemorrhage in High Risk Pregnancies During Elective Cesarean Section, a Randomized Controlled Clinical Trial

Conditions
-----------------
Postpartum Hemorrhage

Intervention / Treatment
-----------------
* Drug: Tranexamic Acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Gestational age of 28 weeks or more. Chronic Hypertension. Preeclapmsia -Eclampsia. Multiple pregnancy. Uterine Liomyomas. Polyhydraminos. Fetal macrosomia. Associated Thrombocytopenia History of postpartum hemorrhage. Exclusion Criteria: Patients with rheumatic heart disease. Patients with history Cardiac Valve Replacement. Current or past history of DVT. Women on any anticoagulant therapy. Sensitivity to tranexamic acid Pregnancies with any abnormally implanted or located placenta.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 42 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tranexamic acid group<br> | Drug: Tranexamic Acid<br>* Tranexamic acid (Kepron, Amoun, Egypt) was given slowly intravenously over 10 minutes just before the skin incision of elective cesarean section to group A. Tranexamic acid injection was prepared by diluting 1g (10 mL) tranexamic acid into 20 ml of 5% glucose.<br>|
| No Intervention: non tranexamic (control) group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevention of postpartum hemorrhage in high risk group | assessment of intraoperative blood loss | intraoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tranexamic acid
Thyroid Autoimmunity and Reproductive Failure in Danish Women

Study Overview
=================
Brief Summary
-----------------
The present Ph.D.-study investigates the mechanisms behind the association between thyroid autoimmunity and reproductive failure.

Official Title
-----------------
Thyroid Autoimmunity and Reproductive Failure - a Study of Autoimmunity in Association With Treatment Outcome in Infertile Danish Women With Infertility or Recurrent Miscarriages.

Conditions
-----------------
Thyroid, Infertility, Autoantibodies, Autoimmunity, Pregnancy Loss

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women followed in the Fertility Clinic Exclusion Criteria: Pregnancy at time of blood sampling. Immune-suppressive ⁄modulatory treatments. Women referred for oocyt donation, genetic testing, and hepatitis and HIV-positivity
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Infertile women study 1<br> | |
| Infertile women study 2<br> | |
| Repeated pregnancy loss<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Live birth |  | 2011-2015 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
thyroid, infertility, autoimmunity, pregnancy loss, autoantibodies
Pharmacokinetics and Pharmacodynamics of Extended-Infusion Cefepime in Continuous Renal Replacement Therapy

Study Overview
=================
Brief Summary
-----------------
This prospective, multi-center study aims to determine the pharmacokinetics and pharmacodynamics of extended-infusion cefepime in continuous renal replacement therapy (CRRT).

Detailed Description
-----------------
This prospective, multi-center study aims to determine the pharmacokinetics and pharmacodynamics of extended-infusion cefepime in CRRT. Patients on CRRT who are being initiated on cefepime 2000 mg IV every eight hours with a four-hour infusion will be considered for enrollment. Pre- and post-membrane serum levels will be drawn at scheduled intervals for both the first dose and again during another dose at steady state. Concomitant effluent and urine levels will also be obtained. A pharmacokinetic analysis will be performed and Monte Carlo simulations will be used to determine the probability of target attainment for various pharmacodynamic endpoints. Documented organism MICs will be used to determine the cumulative fraction of response.

Official Title
-----------------
Pharmacokinetics and Pharmacodynamics of Extended-Infusion Cefepime in Continuous Renal Replacement Therapy

Conditions
-----------------
Drug Mechanism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years Admission to medical intensive care unit (MICU), surgical intensive care unit (SICU), neuroscience intensive care unit (NSICU), or cardiovascular intensive care unit (CVICU), at the University of Cincinnati Medical Center, or the mixed ICU at West Chester Hospital Patients receiving continuous venovenous hemofiltration or continuous venovenous hemodialysis Receiving empiric or definitive cefepime 2 g IV every 8 hours with a four-hour infusion Exclusion Criteria: Prisoners Pregnant women Patients with cystic fibrosis Burns patients 24-hour urine output > 400 mL or unknown

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 |
| --- | --- | --- |
| Composite pharmacokinetic and pharmacodynamic profile of extended-infusion cefepime in CRRT | Each patient will have samples collected on both the first dose and another dose at presumed steady state (dose four, five, or six) to determine the pharmacokinetic and pharmacodynamic profile of extended-infusion cefepime in CRRT. Pharmacokinetic outcomes calculated include half life, volume of distribution, and area under the plasma concentration versus time curve. Sieving and saturation coefficients will also be calculated as appropriate. Time above the minimum inhibitory concentration will be the primary pharmacodynamic outcome studied. | up to 12 months |
Adding L-Carnitine to Clomiphene Citrate for Induction of Ovulation in Women With Polycystic Ovary Syndrome

Study Overview
=================
Brief Summary
-----------------
Polycystic ovary syndrome is one of the most common endocrine disorders, affecting about 6-10% of women in their reproductive age. Anovulation and hyperandrogenism are often present together with hyperinsulinaemia and insulin resistance

Official Title
-----------------
Adding L-Carnitine to Clomiphene Citrate for Induction of Ovulation in Women With Polycystic Ovary Syndrome

Conditions
-----------------
Polycystic Ovary Syndrome

Intervention / Treatment
-----------------
* Drug: Clomiphene Citrate 50mg
* Drug: L-carnitine
* Drug: Placebo Oral Tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary or secondary infertility. Normal Hysterosalpingo-graphy Normal Semen analysis of the husband. Exclusion Criteria: Patient's refusal. Male factors of infertility and/or abnormal Hysterosalpingo-graphy Hyperprolactinemia (prolactin ≥ 22 ng/dl). FSH on day 3 > 15 mIU/mL. Gross ovarian pathology diagnosed by ultrasound.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: study group<br>This group will receive oral clomiphene citrate 50 mg tablet, two times per day from the third day of the cycle until the seventh day of the cycle plus oral carnitine 1g tablet, three times per day from the third day until the day of the pregnancy test. | Drug: Clomiphene Citrate 50mg<br>* oral 50 mg tablets<br>Drug: L-carnitine<br>* 1000 mg oral tablet<br>|
| Active Comparator: control group<br>This group will receive oral clomiphene citrate 50 mg tablet, two times per day from the third day of the cycle until the seventh day of the cycle plus oral placebo tablet, three times per day from the third day until the day of the pregnancy test. | Drug: Clomiphene Citrate 50mg<br>* oral 50 mg tablets<br>Drug: Placebo Oral Tablet<br>* oral tablets identical to L-carnitine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical pregnancy rate | visible intra-uterine gestational sac, with a positive fetal heart beat, viewed during a transvaginal ultrasound (when the b-hCG concentration was more than 1500 IU/l) | 1 month |
Period Tracker at Home Study

Study Overview
=================
Brief Summary
-----------------
This study will assess the usability of a Period Tracker product when used by lay users in their own homes.

Official Title
-----------------
Period Tracker at Home Study

Conditions
-----------------
Menstrual Cycles

Intervention / Treatment
-----------------
* Device: LH Urine Test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female Aged 18 to 45 years Menstrual cycles are 21-60 days long Seeking to predict when her next period will start Seeking to give informed consent and comply with the investigational procedures Has a compatible iPhone with internet access that they are willing to use for the study (iPhone 7+ and iOS 13 and above) Exclusion Criteria: Currently pregnant or breastfeeding Used Clearblue® me (Period Tracker app), Persona Contraception Monitor or Clearblue Advanced Fertility Monitor within the last six months Currently or previously employed by SPD, Abbott, Alere, Unipath, P&G or affiliates Has an immediate* relative currently or previously (within past 5 years) employed by SPD, Abbott, Alere, Unipath or P&G, or affiliates Is a qualified or trainee healthcare professional (HCP) Has professional experience of using dipstick type tests or lateral flow devices Using any treatment which may affect the menstrual cycle (e.g. contraceptive pill) Using hormone replacement medications containing LH or hCG (e.g. Pregnyl®) Is currently seeking to conceive Has been diagnosed with polycystic ovarian syndrome (PCOS) Has PCOS symptoms e.g. very irregular cycles, hirsutism *Immediate relatives are defined as parents, children, siblings or partner/spouse

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: LH Urine Test|Test for the qualitative measurement of LH in urine|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usability of the Period Tracker device when used at home | Number of users scoring 3 or less on a 7 point Likert scale for various questions related to usability of the Period Tracker device after use at home | 28 days (approximately 1 menstrual cycle) |
Exercise-based Cardiac Rehabilitation After Thoracoscopic Ablation in Patients With Persisent Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
Thoracoscopic ablation is a promising treatment of persistent atrial fibrillation. However, the postoperative rehabilitation is very important to prevent early recurrence of atrial arrhythmia. The purpose of this study is to evaluate the efficacy of professional cardiac rehabilitation in patients after thoracoscopic ablation.

Official Title
-----------------
Can Exercise-based Cardiac Rehabilitation Increase Physical Activity in Patients Who Undergoing Totally Thoracoscopic Ablation?

Conditions
-----------------
Atrial Fibrillation, Persistent, Cardiac Rehabilitation, Cardiopulmonary Fitness

Intervention / Treatment
-----------------
* Other: cardiac rehabilitation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who underwent thoracoscopic ablation due to persisent atrial fibrillation Exclusion Criteria: below 18 years over 80 years old malignancy pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Exercise group<br>patients who underwent cardiac rehabilitation | Other: cardiac rehabilitation<br>* rehabilitation performed by professional trainers<br>|
| Control group<br>patients who did not undergo cardiac rehabilitation | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of atrial fibrillation | Atrial fibrillation recurrence after surgical treatment | every 6 months for 1 year | 
| functional recovery | exercise capacity and international physical activity questionnaire | 6 months after intervention |