linjc16/ctgov huggingface dataset:
Retrospective Database Studies

Study Overview
=================
Brief Summary
-----------------
Data collection and comparison of relationships between patient demographics, stimulation protocols and outcomes, retrieval and transfer outcomes, number and quality of oocytes and embryos retrieved and transferred, pregnancy rates and pregnancy outcomes.

Detailed Description
-----------------
No patient treatment is associated with the study.

Official Title
-----------------
Retrospective Database Studies From Reproductive Endocrinology Practice Looking at Relationships Between Demographics, Stimulation Protocols and Outcomes, Retrieval and Transfer Outcomes, Number and Quality of Oocytes and Embryos Retrieved and Transferred, Pregnancy Rates and Pregnancy Outcomes.

Conditions
-----------------
All Patients Undergoing Infertility Treatment

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: none Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improving Rates while Decreasing Adverse Outcomes | Retrospective database analysis in order to advance the field of reproductive endocrinology, to learn about reproductive aging and diminished ovarian reserve, to correlate oocyte and embryo quality with pregnancy rates and outcomes, and to reduce adverse outcomes such as Ovarian Hyperstimulation Syndrome (OHSS) and multiple pregnancy rates. | duration of study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
infertility, IVF
A Comparison of Strict Glucose Control With Usual Care at the Time of Islet Cell Transplantation

Study Overview
=================
Brief Summary
-----------------
Islet transplants for those with type 1 diabetes have enabled many to initially eliminate insulin, however, only a fraction of the transplanted cells typically survive and the functioning of these decrease over time. As a result, most patients will eventually require some insulin. Currently, the cause of this poor survival and decrease in function is not understood; although previous research has demonstrated that even a slightly elevated level of blood glucose can impair islet function. This study will determine if strict blood glucose control at the time of islet transplantation, when the cells are the most fragile, will improve the survival and functioning of transplanted islet cells three months after transplantation.

Official Title
-----------------
A Comparison of Strict Glucose Control With Usual Care at the Time of Islet Cell Transplantation

Conditions
-----------------
Diabetes Mellitus, Type 1, Islet Transplantation

Intervention / Treatment
-----------------
* Other: Strict glucose control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 to 65 years of age more than 5 years since diagnosis of diabetes c-peptide negative Exclusion Criteria: ischemic heart disease previous transplant recurrent infections malignancy (except basal or squamous skin cancer)

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Strict glucose control<br> | Other: Strict glucose control<br>* Blood glucose level to be maintained at 4-6 mmol/L at the time of islet transplantation until two weeks post-transplantation.<br>|
| No Intervention: Standard glucose control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Islet cell function | Function will be assessed three months post-transplantation. | Three months |
Vaginal Misoprostol and Foley Catheter for Induction of Labor

Study Overview
=================
Brief Summary
-----------------
to compare between sequential and concurrent use of vaginal misopristol plus foleys catheter for induction of labor

Detailed Description
-----------------
two groups of patients who are eligible for labor induction were randomized to either sequential use of vaginal misopristol plus foleys catheter or concurrent use of vaginal misopristol plus foleys catheter.

Official Title
-----------------
Sequential Versus Concurrent Use of Vaginal Misoprostol Plus Foley Catheter for Induction of Labor

Conditions
-----------------
Induction of Labor Affected Fetus / Newborn

Intervention / Treatment
-----------------
* Drug: Misoprostol
* Device: Foley Catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Indication for labour induction Term pregnancy with alive fetus Bishop score less than five Exclusion Criteria: Age less than 18 years Previous uterine scar Nonvertex presentation Non-reassuring fetal status Fetal anomalies Fetal growth restriction Genital bleeding Tumors, malformations and/or ulcers of vulva, perineum or vagina

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

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: sequential<br>sequential use of vaginal misoprotol Plus Foley Catheter for Induction of Labor. | Drug: Misoprostol<br>* vaginal Misoprostol Plus Foley Catheter<br>* Other names: cytotec;Device: Foley Catheter<br> <br> |
| Active Comparator: Concurrent<br>Concurrent Use of Vaginal misoprostol Plus Foley Catheter for Induction of Labor. | Drug: Misoprostol<br>* vaginal Misoprostol Plus Foley Catheter<br>* Other names: cytotec;Device: Foley Catheter<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| induction delivery interval (time from starting induction to delivery) | safety issue | 48hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need of oxytocin for augmentation of labour | safety issue | 48h | 
| Number of doses needed to bring on labour | safety issue | 48h | 
| Failed induction (failure to elicit contraction after 72 hours) | safety issue | 72h | 
| Hyperstimulation syndrome | safety issue | 24h | 
| Cesarean section | safety issue | 72h | 
| Severe neonatal morbidity or perinatal death | safety issue | 28 days | 
| Serious maternal morbidity or maternal death | safety issue | 42 days |
Bilateral Bispectral Index (BIS)-Monitoring in Cardiac Surgery Patients

Study Overview
=================
Brief Summary
-----------------
The bispectral index (BIS) is derived from a single-channel electroencephalogram (EEG) and provides information on the anaesthetic depth. Recently, a bilateral two-channel EEG-sensor has been introduced to monitor the BIS on both cerebral hemispheres. In some patients significant left-right differences may occur, whereas no relevant side differences are expected in the majority of patients. The aim of this study is to investigate the incidence, duration and degree of left-right BIS differences examine the relation between BIS differences and occurrence of cognitive deficits

Official Title
-----------------
Investigation on the Diagnostic and Predictive Value of Bilateral Bispectral Index (BIS)-Monitoring in Cardiac Surgery

Conditions
-----------------
Cardiac Surgery Patients

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients scheduled for cardiac surgery Exclusion Criteria: pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 60 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 |
| --- | --- | --- |
| BIS side difference |  | intra- and postoperative (day 1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADL = Activity of Daily Living |  | 6 month after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bispectral index, cardiac surgery, asymmetry
REaCT Integrated Consent Model to Compare Two Standard of Care Regimens

Study Overview
=================
Brief Summary
-----------------
The Integrated Consent Model is being increasingly used internationally to improve patient care. In this feasibility study we will explore whether the model is feasible in practice; and whether it can be used to increase the number of physicians and patients who take part in clinical trials, and address the critical issue around the optimal febrile neutropenia prevention by randomizing eligible patients to either G-CSF or ciprofloxacin.

Official Title
-----------------
Feasibility of Using an Integrated Consent Model to Compare Two Standard of Care Regimens for Primary Prophylaxis of Taxotere/Cyclophosphamide-Induces Febrile Neutropenia

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Drug: G-CSF
* Drug: Ciprofloxacin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed primary breast cancer Planned TC chemotherapy ≥19 years of age Able to provide verbal consent Willing to complete a survey Exclusion Criteria: • Contraindication to either Ciprofloxacin or G-CSF

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: G-CSF<br>Participants will receive a daily injection of G-CSF while on chemotherapy for prevention of febrile neutropenia. | Drug: G-CSF<br> <br> * Other names: granulocyte-colony stimulating factor;|
| Other: Ciprofloxacin<br>Participants will receive Ciprofloxacin 500 mg twice a day by mouth for 10 days of each cycle during chemotherapy for prevention of febrile neutropenia. | Drug: Ciprofloxacin<br> <br> * Other names: Proquin XR;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of randomized patients in each physician's practice | The percentage of randomized patients will be measured by collecting reasons for NOT complying with, or opting-out of the randomized selection compared to the overall accrual. | every 4 weeks up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rates of febrile neutropenia | Rates of febrile neutropenia will be compared between Ciprofloxacin and G-CSF | Once when the last participant completes chemotherapy up to year 2 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast
Laughter Frequency and Fibromyalgia Symptoms

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate whether daily laughter frequency is associated with pain intensity and emotional state ratings in individuals who have fibromyalgia syndrome.

Detailed Description
-----------------
Participants will be asked to provide (or authorize the researcher to obtain) fibromyalgia diagnosis confirmation from a health care provider. Initially, participants will complete a demographics form and two screening assessments. Then for 14 days, they will be asked to rate their momentary mood and overall pain levels three times per day (shortly after waking up, around 3:00 p.m., and at about an hour before bedtime). At the same time, they will be asked to log each instance of laughter as it occurs, daily, for 14 days. They will carry the log with them throughout each day in order to document each instance of laughter.

Official Title
-----------------
The Relationships Between Laughter Frequency, Pain Perception, and Affect in Fibromyalgia Patients

Conditions
-----------------
Fibromyalgia

Intervention / Treatment
-----------------
* Behavioral: Laughter Frequency


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals who have fibromyalgia syndrome Exclusion Criteria: None.

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 |
| --- |
|Behavioral: Laughter Frequency|Relationships between laughter frequency, momentary mood state, and pain will be observed.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Laughter Frequency | Documenting each instance of laughter throughout each day. | 14 days | 
| Pain Ratings | Rating overall pain from 0 to 10, three times daily | Three times per day for 14 days | 
| Emotional State | Rating momentary emotional state three times per day | Three times per day for 14 days |
Comparison of the Efficacy and Safety of Ivermectin to Permethrin

Study Overview
=================
Brief Summary
-----------------
Comparison of the efficacy and safety of a single administration of ivermectin to a single administration of permethrin for the treatment of scabies

Detailed Description
-----------------
Administration of ivermectin or permethrin on day0 Clinical examination and pictures on day0, day14 and day28 Blood sample on day0 VAS for pruritus, DLQI and SF-36 on day0, day14 and day28

Official Title
-----------------
A Randomised, Double Blind, Double Dummy Study to Compare the Efficacy and Safety of a Single Administration of Ivermectin to a Single Administration of Permethrin for the Treatment of Scabies

Conditions
-----------------
Scabies

Intervention / Treatment
-----------------
* Drug: Administration of ivermectin or permethrin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least one of the following inclusion criteria: Scabies tunnels Positive microscopic examination (acarids, faeces or ova) At least two of the three following inclusion criteria: Non-specific injuries with a typical distribution pattern Serious itching which increases during the night Family or contacts with similar complaints Exclusion Criteria: Treatment for scabies < 4 weeks ago Treatment with corticoids < 1 week ago Pregnancy Breast-feeding HIV Serious immunodepressive patients Sensitivity or allergy to one of the components of the study medication Damage of the central nerve system

Ages Eligible for Study
-----------------
Minimum Age: 5 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: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Administration of ivermectin or permethrin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical healing of the skin injuries |  | on day28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease of itching |  | on day28 | 
| Amelioration of the life quality |  | on day28 | 
| Number and gravity of adverse events |  |  |
Bishop Score and Transvaginal Ultrasound for Preinduction Cervical Assessment in Multiparas

Study Overview
=================
Brief Summary
-----------------
To compare the ultrasonographic cervical length with the Bishop score in determining the administration of prostaglandin for preinduction cervical ripening in multiparous women at term.

Conditions
-----------------
Failed Induction of Labor

Intervention / Treatment
-----------------
* Other: Assessment of cervical status


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: multiparous patients singleton pregnancy live fetus with vertex presentation intact amniotic membranes > 37 weeks gestation absence of labor no previous uterine surgical procedures Exclusion Criteria: major congenital anomaly
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bishop score<br> | Other: Assessment of cervical status<br>* Assessment of cervical status based on Bishop score versus sonographically measured cervical length<br>|
| Active Comparator: transvaginal ultrasound<br> | Other: Assessment of cervical status<br>* Assessment of cervical status based on Bishop score versus sonographically measured cervical length<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful labor induction | Induction success was defined as an ability to achieve the active phase of labor corresponding to a cervical dilatation of ≥ 4 cm within 11 hours of initiating oxytocin (i.e., within 22 hours of the administration of a dinoprostone vaginal insert) on the first day of induction. | Eleven hours of initiating oxytocin on the fist day of induction | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the need for oxytocin induction, percentage of patients treated with prostagladins | the interval from start of oxytocin to the active phase of labor the interval from start of oxytocin to delivery vaginal delivery within 24 hours of starting induction the incidence of cesarean delivery | After removing prostaglandin, the following day when an intravenous oxytocin infusion was started | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multiparas, Bishop score, Cervical length, Cervical ripening
The Effect of Contrast Media on Erythrocytes in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to test the effect that contrast media (dye) has on cellular integrity (structure)

Detailed Description
-----------------
The influence of several radiological contrast media on erythrocyte morphology and function has been investigated in the past (1). However, published data is sparse and does not include the assessment of iso-osmolar agents as compared to low-osmolar agents. In addition, the effect of the injection of contrast media at higher temperatures (i.e. > room or body temperature), which may be beneficial for the rapid injection of more viscous contrast media at multi detector-row CT angiography, has never been evaluated. We intend to assess the hypothesis, that iso-osmolar contrast media (i.e. Visipaque) exerts less effect on erythrocyte morphology and function as compared to low-osmolar agents. In addition, we intend to identify the upper temperature limit, at which contrast media can be injected, without affecting erythrocyte integrity. Subjects will have up tp 400 mLs (approximately 26 tablespoons) of blood drawn. The blood will be kept at body temperature in a petri dish or similar container and exposed to contrast media (dye).

Official Title
-----------------
The Effect of Low-Osmolar and Iso-Osmolar Contrast Media on Erythrocytes in Healthy Volunteers.

Conditions
-----------------
Healthy Volunteers

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must be at least 18 years old Subjects must be at least 110lbs and Exclusion Criteria: Subjects may not be pregnant Subjects must not possess any medical conditions that would preclude them from participating

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy Volunteers