linjc16/ctgov huggingface dataset:
Treatment of Endometrial Hyperplasia With an Intrauterine Device (IUD)

Study Overview
=================
Brief Summary
-----------------
The purpose of this research is to determine the effectiveness of the intrauterine device (IUD) called Mirena when compared to the Provera tablets used in treating this condition.

Detailed Description
-----------------
Endometrial hyperplasia without atypia is a condition usually caused by excessive stimulation of the uterine lining (endometrium) by estrogens, and may cause irregular bleeding as a presenting symptom, but rarely may progress to endometrial cancer, which makes treatment important. The only treatment approved so far is medroxyprogesterone acetate tablets (progesterone), also known as Provera.

Official Title
-----------------
Levonorgestrel Containing Intrauterine Device in the Treatment of Endometrial Hyperplasia Without Atypia

Conditions
-----------------
Endometrial Hyperplasia

Intervention / Treatment
-----------------
* Device: Intrauterine Device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologic diagnosis of simple or complex endometrial hyperplasia without atypia Normal pap smear within one year Exclusion Criteria: Diabetes Family history of endometrial cancer Contraindications for the intrauterine device

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Intrauterine Device|Mirena and Provera|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathologic examination of the specimens obtained by endometrial biopsy to determine the regression of endometrial hyperplasia without atypia compared to Provera |  | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects |  | 90 days | 
| Bleeding profile |  | 90 days | 
| Estradiol and progesterone levels |  | 90 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endometrial Hyperplasia without atypia
Clinical Evolution and Becoming of Adult Patients Infected With Covid-19 Hospitalized at Strasbourg University Hospitals

Study Overview
=================
Brief Summary
-----------------
A SARS-CoV-2 infection emerged in China in December 2019, the severity of which is linked to acute respiratory distress syndrome1. The rate of emergency visits in Bas-Rhin for suspected Covid-19 increased, compared to the French average, at the end of the 10th week of 2020. Compared to the onset of symptoms, Chinese studies estimate the onset of dyspnea on the 7th day3 and admission to the emergency room between the 5th and the 9th day4. But this duration varies according to the epidemic period5, the geographical location6 and a later emergency admission is associated with an increase in mortality in the Chinese population7. The need for oxygen, which is not noted in Chinese studies8, is a reflection of the onset of respiratory worsening and a major factor in hospitalization. There is no study on the changing profile of the French population to date its onset.

Official Title
-----------------
Clinical Evolution and Becoming of Adult Patients Infected With Covid-19 Hospitalized at the University Hospitals of Strasbourg : A Retrospective Observational Study

Conditions
-----------------
Covid-19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female aged 18 or over Admitted to the NHC emergency room and hospitalized at the Strasbourg University Hospitals (HUS) between 06/03/2020 and 05/04/2020. With SARS-CoV-2 RT-PCR on a positive nasopharyngeal sample taken at the SU. Exclusion Criteria: Refusal to participate in the study Return home from the SU Transfer to another establishment Patient under the protection of justice Patient under guardianship, curatorship

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 |
| --- | --- | --- |
| Retrospective evaluation of the clinical evolution and becoming of adult patients infected with Covid-19 hospitalized at the University Hospitals of Strasbourg from the Emergency Structure |  | Files analysed retrospectily from March 06, 2020 to April 05, 2020 will be examined] | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, COVID-19 Pandemic, Sars-cov-2, Emergency Department
Stored RBC Transfusion and Immonomodulation

Study Overview
=================
Brief Summary
-----------------
Transfusion of RBC is associated with post operative infections. Our hypothesis is that stored blood could be related with increased post operative infection risk. Surgical patients transfused during the operation or immediately after will be included in our study. Patients will receive fresh or old blood during the whole recovery.

Official Title
-----------------
Infective Complication After Surgery and Transfusion of Allogenic RBC Fresh or Stored

Conditions
-----------------
Infections

Intervention / Treatment
-----------------
* Other: Fresh RBC
* Other: Old RBC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients transfused during or in 24h after surgical operation Exclusion Criteria: Patients transfused during the 30 days before the operation Immunodepressed patients Infections during the 30 days before operations Emergency surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fresh group<br>Fresh group will receive RBC stored for less than 14 days | Other: Fresh RBC<br>* Patients will receive fresh blood only<br>|
| Active Comparator: Old group<br>Old group will receive RBC stored for 14 days or more | Other: Old RBC<br> <br> * Other names: Patients will receive blood stored for 14 days or more;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of infections |  | 28 days |
Study of Genotype and Phenotype Expression in Congenital Nephrogenic Diabetes Insipidus

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Determine the relationship between genotype variations and clinical phenotype in patients with congenital nephrogenic diabetes insipidus.

Detailed Description
-----------------
PROTOCOL OUTLINE: A detailed family history is obtained from all participants. Whenever possible, standard growth curves of affected children are obtained. Participants then undergo clinical studies of antidiuretic function. A standard fluid deprivation-vasopressin challenge is performed with timed measurements of osmolality, electrolytes, creatinine, and vasopressin. The next day, blood pressure, plasma cyclic AMP, GMP, von Willebrand Factor, Factor VIII, and urine osmolality are measured during a water load desamino-D-arginine vasopressin (dDAVP) infusion test. Participants with a confirmed diagnosis of congenital diabetes insipidus are then treated with chlorothiazide. Daily urine volume and osmolality are determined before and after therapy. Sodium and fluid are not restricted. For each family, the entire vasopressin V2 gene of at least 1 affected male, and where possible at least 1 obligate carrier and 1 unaffected brother of a patient is sequenced. In addition, a detailed Xq28 haplotype analysis is done to identify the origin of de novo mutations. If no mutation is found and the disorder is not transmitted in an X-linked mode, both alleles of the gene that codes for aquaporin-II are also sequenced. DNA is collected by mail from as many kindred as possible who do not participate in the clinical studies.

Conditions
-----------------
Diabetes Insipidus, Nephrogenic

Intervention / Treatment
-----------------
* Drug: chlorothiazide


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: Known or suspected congenital nephrogenic diabetes insipidus Clinically and genetically unaffected relatives entered as controls --Patient Characteristics-- Age: 6 months to 70 years

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 70 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: chlorothiazide|nan|

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
-----------------
diabetes insipidus, endocrine disorders, rare disease
More-2-Eat; Implementation of INPAC

Study Overview
=================
Brief Summary
-----------------
M2E is a developmental evaluation of the implementation of the Integrated Nutrition Pathway for Acute Care, in five medical units in five hospitals in Canada.

Conditions
-----------------
Acute Care Medical

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: admitted to study unit no delirium or dementia return to community anticipated Exclusion Criteria: unable to communicate in English or French

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 |
| --- | --- | --- |
| Implementation success of Integrated Nutrition Pathway for Acute Care (INPAC) | INPAC is an evidence based pathway to improve detection, prevention and treatment of malnutrition in acute care. The primary outcome of this study is the trajectory and proportion of care activities that happen for a given population e.g. % screened, assessed with SGA, have standard care strategies provided etc. | admission | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
malnutrition, food intake, frailty
Pudendal Nerve Block for Post-Episiotomy Pain Relief

Study Overview
=================
Brief Summary
-----------------
Unilateral vs. Bilateral Pudendal Nerve Block for Post-Episiotomy Pain Relief: A Randomized Clinical Trial

Official Title
-----------------
Unilateral vs. Bilateral Pudendal Nerve Block for Post-Episiotomy Pain Relief: A Randomized Clinical Trial

Conditions
-----------------
Pain, Postoperative

Intervention / Treatment
-----------------
* Procedure: Pudendal Nerve Block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Term (37 to 42 weeks gestation), primigravid women with singleton vertex fetus Exclusion Criteria: Women with bleeding disorders, known hypersensitivity to local anesthetics, chronic use of pain medication, had previous vaginal surgery, extensive vulvovaginal infection, malposition or malpresentation were excluded from the study. Also, women who failed to deliver vaginally, had extensive perineal or cervicat tears, or had instrumental delivery were excluded from the final analysis of 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Bupivacaine
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Unilateral PNB<br>Unilateral Pudendal Nerve Block | Procedure: Pudendal Nerve Block<br>* Pudendal Nerve Block<br>* Other names: Bupivacaine;|
| Active Comparator: Bilateral PNB<br>Bilateral Pudendal Nerve Block | Procedure: Pudendal Nerve Block<br>* Pudendal Nerve Block<br>* Other names: Bupivacaine;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale for pain scoring | visual analogue scale (VAS) from 0 to 100 with 0 corresponding to no pain at all and 100 as the worst pain the woman can describe | 48 hours |
Assessment of Stress Levels in Consumers Using Ovulation Tests in Order to Conceive

Study Overview
=================
Brief Summary
-----------------
Approximately 150 female volunteers wishing to become pregnant will be recruited via web recruitment from around the UK and randomised 1:1 to receive Clearblue Digital ovulation tests (active arm) or no aid to conception (control arm) for 2 full menstrual cycles. All volunteers will complete study questionnaires and provide a urine sample at designated time points though out the menstrual cycle. A sub-arm to this study, applied the same protocol to women in an infertility treatment setting; Royal Hallamshire Hospital, Sheffield. Additional exclusion criteria were applied to this cohort; had regular menstrual cycles between 25 and 35 days, and who did not have a diagnosis of bilateral or unilateral tubal blockage, documented anovulation or severe male-factor infertility (with <5 million motile sperm per ejaculate). For this arm, the protocol was reviewed by Sheffield Research Ethics Committee 09/H1308/134.

Official Title
-----------------
Assessment of Stress Levels in Consumers Using Ovulation Tests in Order to Conceive

Conditions
-----------------
Stress

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provide written informed consent to participate in the study and agree to comply with study procedures. Has menstrual bleeds. Seeking to become pregnant. Living in UK Exclusion Criteria: Used hormonal contraception within the last 3 months. Currently undergoing fertility treatment or investigation. Diagnosed as infertile following investigations. Drug or alcohol dependency. history of depression, anxiety or panic attacks

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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 |
| --- | --- |
| Active<br>Use of ovulation tests to aid conception | |
| Control<br>No ovulation tests to aid conception | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cortisol Measurement | Measurement of Urinary Cortisol throughout menstrual cycle | Twice monthly | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pregnancy, Ovulation tests, stress, Wishing to become pregnant
Whole Body MRI Imaging in Multiple Myeloma at 3 Tesla MRI : Added Value of Diffusion Weighted Imaging

Study Overview
=================
Brief Summary
-----------------
Whole body MRI with diffusion weighted imaging is a useful imaging tool staging and diagnosis therapy monitoring All patients will be scanned before and during treatment. The findings on diffusion weighted imaging will be correlated to the golden standard (computer tomography and MRI (T1 and STIR)).

Official Title
-----------------
Whole Body MRI Imaging in Multiple Myeloma at 3 Tesla MRI: What is the Added Value of Diffusion Weighted Imaging in Diagnosis and Follow-up

Conditions
-----------------
Multiple Myeloma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with clinical and laboratory findings, highly suggestive for multiple myeloma. Exclusion Criteria: All patients who are not allowed to be scanned on MRI (Pacemaker, implants ed.)

Ages Eligible for Study
-----------------
Minimum Age: 25 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 |
| --- | --- |
| Indolent myeloma patient<br> | |
| Symptomatic Myeloma patient<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation | Validation of whole body MRI diffusion-weighted imaging in multiple myeloma at 3 Tesla MRI: correlation of the new MRI imaging technique (diffusion weighted imaging)to standard validated imaging technique (Computer Tomography and Magnetic Resonance Imaging) | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Therapy assessment | Whole body MRI with Diffusion weighted imaging is useful for treatment monitoring in multiple myeloma patients during and after therapy. Measurement of apparent diffusion coefficient (ADC) and comparison of ADC before, during and after therapy. Correlation of ADC with clinical findings and standard MRI findings. | 4 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Whole body MRI, Multiple myeloma, Diffusion Weighted MRI, Whole body scan
Metabolic Profile and Adipokine Levels in Young Hyperandrogenemic Females

Study Overview
=================
Brief Summary
-----------------
Assessement of basic metabolic profile and adipokine levels in young hyperandrogenemic females.

Official Title
-----------------
Metabolic Profile and Adipokine Levels in Young Hyperandrogenemic Females

Conditions
-----------------
Hyperandrogenism, Obesity, Metabolic Disease, Metabolic Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hyperandrogenemia informed consent to participate female sex age 18-40 years old Exclusion Criteria: male sex no consent given

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Basic metabolic profile. | Serum lipids, uric acid, fasting glucose and insulin. | Day of blood testing - no further assessment planned (observational study). | 
| Adipokines. |  | Day of blood testing - no further assessment planned (observational study). |
Dedicated Sheath Feasibility Study

Study Overview
=================
Brief Summary
-----------------
Dedicated Sheath feasibility study: A prospective, open-label study to evaluate the feasibility and safety of the Valve Medical Dedicated Sheath during Balloon Aortic Valvuloplasty (BAV).

Detailed Description
-----------------
This is an open-label, prospective, single arm clinical study. Up to 15 patients undergoing valvular intervention will be enrolled. Follow up will take place at 1, 6 and 24 hours post procedure. No follow up visits are required. During the study, the patient will undergo the following tests: Physical examination (includes blood pressure, age, height, weight). Echo assessments prior to procedure. Hemodynamic study prior and post BAV. Full blood count Angiography

Official Title
-----------------
A Prospective, Open-label Study to Evaluate the Feasibility and Safety of the Valve Medical Dedicated Sheath During Balloon Aortic Valvuloplasty

Conditions
-----------------
Aortic Stenosis

Intervention / Treatment
-----------------
* Device: Valve Medical Dedicated Sheath version 00


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years. Patient understands the implications of participating in the study and provides written informed consent. The patient has an indication for balloon aortic valvuloplasty (BAV). Exclusion Criteria: Peripheral vessel anatomy or peripheral vascular disease that would preclude the insertion of the 12 Fr. sheath. Any illness or condition which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Valve Medical Dedicated Sheath<br>Valve Medical Dedicated Sheath version 00 | Device: Valve Medical Dedicated Sheath version 00<br>* The Valve Medical Dedicated Sheath is intended to be used as an introducer sheath during BAV procedures<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device success |  | Outcome measures will be assessed at 1, 6 and 24 hours post procedure. | 
| Procedure Safety: Adverse Event Assessment for device related and unrelated events |  | Outcome measures will be assessed at enrollment, throughout the procedure and 1, 6 and 24 hours post procedure. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dedicated sheath