linjc16/ctgov huggingface dataset:
Urinary Procedures Performed by Gynecologists, Results and Learning Curves.

Study Overview
=================
Brief Summary
-----------------
Urinary procedures such as placing a JJ catheter, performing a psoic bladder, a Bricker technique or even a partial cystectomy are relatively frequent procedures in the context of the surgical management of gynecological cancer or endometriosis in order to obtain maximum reduction in oncology, or to overcome all endometriotic lesions when they affect the urinary tract. However, gynecological surgeons are not always trained in these specific procedures, the learning of which is crucial in the optimal management of these patients. The aim of the research is to describe the surgical experience in terms of urinary actions (JJ catheter placement, psoic bladder, Bricker technique, cystectomy) over the past 10 years and determine a learning curve for a surgical team made up of only gynecological surgeons

Official Title
-----------------
Urinary Procedures Performed by Gynecologists, Results and Learning Curves.

Conditions
-----------------
Gynecologic Cancer, Endometriosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Adult woman (≥18 years old) Woman with gynecological cancer or endometriosis, having undergone surgery between 01/01/2010 and 04/30/2021 at Strasbourg University Hospital With the performance of urological procedures during the operation performed by a surgical team composed of a gynecological surgeon Woman who did not express her opposition to the reuse of her data for the purposes of this research. Exclusion criteria: Woman who expressed her opposition to participating in the study Surgery performed by a team of surgeons not composed exclusively of gynecologists

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Describe the surgical experience in terms of urinary procedures (JJ catheter placement, psoic bladder, Bricker's technique, cystectomy) over the past 10 years |  | Files analysed retrospectively from January 01, 2010 to April 30, 2021 will be examined] | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gynecologic Cancer, Endometriosis
Simultaneous Fluoroscopic and Endoscopic Examination of the Oropharyngeal Phase of Deglutition

Study Overview
=================
Brief Summary
-----------------
To correlate findings between two commonly-used types of swallowing studies: videofluoroscopy and flexible endoscopic evaluation of swallowing (FEES).

Detailed Description
-----------------
The specific aim of this study is to correlate findings between two commonly-used types of swallowing studies: videofluoroscopy and flexible endoscopic evaluation of swallowing (FEES). Specifically, the timing of swallowing events will be correlated between teh two studies. In addition, the pharyngeal constriction ratio (a validated measure of pharyngeal strength on videofluoroscopy) will be compared with the pharyngeal squeeze maneuver (an assessment of pharyngeal strength on FEES), with the hypothesis that there will be a strong correlation between PCR and pharyngeal squeeze.

Official Title
-----------------
Simultaneous Fluoroscopic and Endoscopic Examination of the Oropharyngeal Phase of Deglutition

Conditions
-----------------
Dysphagia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: complaints of dysphagia scheduled to undergo videofluoroscopy able to tolerate both videofluoroscopic evaluation of swallowing and FEES Exclusion Criteria: age less than 18 contraindications to videofluoroscopy (reaction to barium, possible pregnancy) contraindications to FEES (bilateral obstructing nasal pathology or nasopharyngeal stenosis) specific/vulnerable populations (children, mentally handicapped, pregnant women, fetuses, prisoners, cognitive impairment, life-threatening disease, social or economic disadvantage)

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dysphagia, videofluoroscopy, flexible endoscopic evaluation
Long-term Study of KAD-1229 in Type 2 Diabetes Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the long-term safety and efficacy of KAD-1229 as combination therapy with biguanide or DPP-4 inhibitor in type 2 diabetes patients who show inadequate glycemic control with diet, and biguanide or DPP-4 inhibitor monotherapy.

Official Title
-----------------
A Multicenter, Open Label, Long-term Study of KAD-1229 in Type 2 Diabetes Patients Who Show Inadequate Glycemic Control With Diet, and Biguanide or DPP-4 Inhibitor Monotherapy

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Drug: KAD-1229


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes patients who show inadequate glycemic control with diet, and biguanide or DPP-4 inhibitor monotherapy Age in the 20 years or over inclusive HbA1c in the range of ≥ 6.5 to < 9% Exclusion Criteria: Type 1 diabetes mellitus Patients with serious diabetic complications and other serious complications

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KAD-1229<br> | Drug: KAD-1229<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidences of Adverse Events |  | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in HbA1c at 52 Weeks |  | at week 0 and week 52 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 diabetes, HbA1c, Long-term study
Polarity Therapy for American Indian Caregivers of Dementia Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the effectiveness of polarity therapy (PT), a complementary and alternative medicine treatment, in American Indian caregivers living in the Pacific Northwest.

Detailed Description
-----------------
The caregivers of people with dementia experience high levels of stress and are at particularly high risk for physical and mental illness. Although stress and illness are serious problems among American Indian caregivers in the Northwest, few studies have concentrated on this population. PT is a treatment that involves awareness of one's energy field and touch therapy; it has been shown to provide several physiological, biological, and psychological benefits. This study will determine whether PT is more effective than respite from caregiving in reducing stress, anxiety, and depression and improving health function and overall quality of life in American Indian caregivers. Participants will be randomly assigned to receive either eight weekly sessions of PT or 3 hours of weekly respite from caregiving for 8 weeks. At the beginning of the study and at Weeks 4 and 8, participants will complete questionnaires and self-report scales on stress, anxiety, depression, and quality of life. In addition, heart rate variability and levels of cortisol will be measured at study entry and Weeks 4 and 8.

Official Title
-----------------
Polarity Therapy for Dementia Caregivers

Conditions
-----------------
Stress, Depression, Anxiety

Intervention / Treatment
-----------------
* Procedure: Polarity therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Caregiver of a family member with dementia for at least 4 hours a day American Indian Exclusion Criteria: Nerve disorders caused by diabetes Use of beta blockers

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 65 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Polarity therapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived stress |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Caregivers, Complementary Therapies
Food Intake Among Women and Men in Fertility Treatment

Study Overview
=================
Brief Summary
-----------------
Worldwide infertility is highly prevalent and lifestyle factors, such as food intake, could have an essential role in the success of a fertility treatment. The literature is not consistent and adequate for recommendations to the increasing number of women and men of reproductive age who ask for lifestyle guidance. Therefore, the aims of the Food & Fertility study will be to investigate the association between food intake and semen quality, pregnancy- and live birth rates in women and men undergoing assisted reproductive technology (ART) treatment.

Detailed Description
-----------------
The Food & Fertility study is a multicenter prospective cohort study which is planned to enroll a total of 4000 women and men between 2022 and 2024. The data collection will take place in four fertility clinics through a web-based food frequency questionnaire (FFQ). Data on sperm quality and pregnancy- and live birth rates will be obtained from medical records and national registers.

Official Title
-----------------
Food & Fertility - Does Food Intake Affect Your Fertility?

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Other: Food intake among women and men in fertility treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women and men undergoing fertility treatment: in vitro fertilization (IVF), intracytoplasmatic sperm injection (ICSI), frozen-thawed embryo transfer (FET) or intrauterine insemination (IUI). Availability of a semen sample analyzed 3 months before or after filling in the FFQ. Read and understands Danish. Exclusion Criteria: Treatment with double donation (both semen and oocyte donation)
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Women<br> | Other: Food intake among women and men in fertility treatment<br>* Filling in an FFQ<br>|
| Men<br> | Other: Food intake among women and men in fertility treatment<br>* Filling in an FFQ<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Probability of live birth |  | From filling out the FFQ to birth (approximately 9-10months) | 
| Probability of pregnancy |  | From filling out the FFQ to end of treatment cycle (approximately 3 weeks) | 
| Semen quality |  | +/- 3 months from filling out the FFQ | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fertility, Assisted reproductive techniques, Food, Diet, Dietary supplements, Semen quality, Live birth
Evaluation of the Quality of Life of Patients Requiring Intestinal Cleansing Using Oral Medications to Imaging Procedure by Patient Reported Outcome

Study Overview
=================
Brief Summary
-----------------
Objective: The primary objective of this study is to assess the quality of life of people treated with oral phosphate compared with polyethylene glycol + electrolytes to imaging procedures, according to the outcome variables reported by patients. Type of study: A non-interventional observational analytic prospective cohort study. Sample: We will include people who need bowel cleansing for the realization of imaging tests Exposures: - oral sodium phosphate normal regimen Oral sodium phosphate with modified diet Polyethylene Glycol + electrolytes Follow-up time: 8 days after the bowel preparation Outcomes: Boston Scale measure Safety Differences between groups in blood test (Sodium, Potassium, Calcium)

Conditions
-----------------
Bowel Preparation

Intervention / Treatment
-----------------
* Drug: Oral Sodium Phosphate - Normal preparation
* Drug: Oral sodium phosphate - Modified Preparation
* Drug: polyethylene glycol + Electrolytes


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients which have order for an imaging procedure that requires bowel cleansing Older than 18 years and younger than 65 years old Accept to participate in this study

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Oral Sodium Phosphate - Normal preparation<br>Oral sodium phospate exposure with special diet (Liquid) | Drug: Oral Sodium Phosphate - Normal preparation<br> <br> * Other names: Travad;|
| Oral Sodium Phosphate - Modified preparation<br>Oral sodium phospate exposure with special diet (Liquid), but the participant can normally lunch the day before the test | Drug: Oral sodium phosphate - Modified Preparation<br> <br> * Other names: Travad;|
| polyethylene glycol + Electrolytes<br>polyethylene glycol + Electrolytes exosure with special diet (Liquid) | Drug: polyethylene glycol + Electrolytes<br> <br> * Other names: PEG;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Boston scale for bowel cleansing |  | 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events |  | 8 days | 
| Quality of life | Quality of life measured with EQ5D-3L scale | 8 days | 
| Blood creatinine |  | 8 days | 
| Blood urea nitrogen (BUN) |  | 8 days | 
| Blood Sodium |  | 8 days | 
| Blood Potassium |  | 8 days | 
| Blood Calcium |  | 8 days | 
| Blood Phosphorus |  | 8 days |
Efficacy of Ultrasound Guided Hyaluronic Injection in Treatment of Trigger Finger

Study Overview
=================
Brief Summary
-----------------
Comparing the Efficacy of Ultrasound Guided Hyaluronic Injection with Ultrasound Guided Corticosteroid Injection in Treatment of Trigger Finger

Detailed Description
-----------------
Randomized controlled trial which designed to compare the success rate, recurrence rate and functional outcomes of patients with trigger finger whom was treated with ultrasound guided hyaluronic acid injection to ultrasound guided corticosteroid injection

Official Title
-----------------
Comparing the Efficacy of Ultrasound Guided Hyaluronic Injection With Ultrasound Guided Corticosteroid Injection in Treatment of Trigger Finger

Conditions
-----------------
Trigger Digit

Intervention / Treatment
-----------------
* Drug: Hyaluronic Acid
* Drug: Triamcinolone Acetonide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 20 years old Quinnell grade I, II, III Acute (< 6 months) Exclusion Criteria: Quinnell grade IV Diabetes mellitus Rheumatoid arthritis Pregnancy Patient with prior injection or surgery of trigger finger Patient who are allergy to hyaluronic acid

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hyaluronic acid<br>Hyaluronic acid | Drug: Hyaluronic Acid<br>* 1 ml of Low molecular weight hyaluronic acid injection under ultrasound guidance after subcutaneous 0.5ml of 1%lidocaine injection<br>* Other names: Hyalgan;|
| Active Comparator: Triamcinolone acetonide<br>10mg/ml Triamcinolone acetonide | Drug: Triamcinolone Acetonide<br>* 1ml of 10 mg of triamcinolone injection under ultrasound guidance after subcutaneous 0.5 ml 1%lidocaine injection<br>* Other names: Shincort inj.;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate | reduction of symptom which needed no further treatment at follow up | 1 month, 3 month, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score | Visual analogue scale changes | 1 month, 3 month, 6 months | 
| Functional outcome | Disability of the arm, shoulder and hand score | 1 month, 3 months, 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
trigger finger, trigger thumb, ultrasound guided, hyaluronic acid
Effect of Cyclosporine on the Pharmacokinetics (PK) of AT-527 (R07496998)

Study Overview
=================
Brief Summary
-----------------
This study will determine the effect of cyclosporine on the PK of AT-527 (R07496998) in healthy male subjects

Official Title
-----------------
A Phase 1, Randomized, Open-Label Study to Evaluate the Effect of Cyclosporine on the Plasma Pharmacokinetics of AT-527 in Healthy Adult Male Subjects

Conditions
-----------------
Healthy Volunteer Study

Intervention / Treatment
-----------------
* Drug: AT-527 550 mg + cyclosporine
* Drug: AT-527 550 mg + cyclosporine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must agree to use two methods of birth control from Screening through 90 days after administration of the last dose of study drug Minimum body weight of 50 kg and body mass index (BMI) of 18-29 kg/m2 Willing to comply with the study requirements and to provide written informed consent Exclusion Criteria: Infected with hepatitis B virus, hepatitis C virus, HIV or SARS-CoV-2 Abuse of alcohol or drugs Use of other investigational drugs within 28 days of dosing Concomitant use of prescription medications, or systemic over-the-counter medications Other clinically significant medical conditions or laboratory abnormalities

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

Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- |
| Experimental: AT-527 550 mg + cyclosporine (simultaneous)<br>n=12 | Drug: AT-527 550 mg + cyclosporine<br>* 550 mg AT-527 alone on Day 1 and 550 mg AT-527 plus 600 mg cyclosporine administered simultaneously on Day 7 Other Names: AT-527 is also known as R07496998<br>|
| Experimental: AT-527 550 mg + cyclosporine (staggered)<br>n=12 | Drug: AT-527 550 mg + cyclosporine<br>* 550 mg AT-527 alone on Day 1 and 550 mg AT-527 plus 600 mg cyclosporine administered on Day 7 (with dosing offset by 2 hrs) Other Names: AT-527 is also known as R07496998<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK) of AT-527 (R07496998): Cmax | Maximum plasma concentration (Cmax) | Day 1 vs Day 7 | 
| Pharmacokinetics (PK) of AT-527 (R07496998): AUC | Area under the concentration-time curve (AUC) | Day 1 vs Day 7 |
Copeptin in the Differential Diagnosis of Dysnatremia in Hospitalized Patients

Study Overview
=================
Brief Summary
-----------------
Background: Hypo- and hypernatremia are common in hospitalized patients. The differential diagnosis of dysnatremia is challenging. Osmotically inadequate secretion of antidiuretic hormone (ADH) is the predominant mechanism in most dysnatremic disorders. ADH measurement is cumbersome. It is derived from a larger precursor peptide along with copeptin, which is a more stable peptide directly mirroring the production of ADH. Objective: To evaluate the additional value of copeptin to improve a currently used algorithm in the differential diagnosis of (A) severe hypoosmolar hypo- and (B) severe hypernatremia. Design: Prospective observational study.

Official Title
-----------------
Copeptin in the Differential Diagnosis of Dysnatremia in Hospitalized Patients

Conditions
-----------------
Hyponatremia, Hypernatremia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hyponatremia <125 or hypernatremia >155 mmol/L Exclusion Criteria: no informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 110 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 |
| --- | --- |
| hospitalized patients<br>hospitalized patients with hyponatremia | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diagnostic accuracy of copeptin within hospital stay | diagnostic accuracy will be determined by receiver operated curve (ROC) analysis. The study is powered to detect a difference of copeptin levels between patients with partial central diabetes insipidus (DI) and patients with primary polydipsia. | participants will be followed for up to 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hyponatremia, hypernatremia