linjc16/ctgov huggingface dataset:
PTNS on Urinary and Global Quality of Life in MS Patients

Study Overview
=================
Brief Summary
-----------------
This is a single-centered, prospective, longitudinal, observational cohort study of patients with MS who suffer from lower urinary tract symptoms (LUTS) and are refractory to two prior treatment modalities who have elected to pursue PTNS therapy for LUTS.

Official Title
-----------------
Impact of Percutaneous Posterior Tibial Nerve Stimulation on Urinary and Global Quality of Life in Multiple Sclerosis Patients

Conditions
-----------------
Multiple Sclerosis, Lower Urinary Tract Symptoms, Neurogenic Bladder, Overactive Bladder, Urinary Incontinence, Urinary Urge Incontinence

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Multiple Sclerosis Lower urinary tract symptoms (urinary frequency, urgency and/or incontinence) Failed prior first and second line therapy (behavioral and pharmacotherapy) Electing for Posterior Tibial Nerve Stimulation therapy for urinary symptoms Patients performing Intermittent Catheterization are Eligible Exclusion Criteria: Indwelling catheters (urethral or suprapubic) Currently pregnant or planning pregnancy Unable to attend weekly office visits for PTNS Urodynamic findings of bladder outlet obstruction History of: bladder reconstruction (augmentation cystoplasty, catheterizable channel) cystectomy bladder stones pacemaker or defibrillator malignancy of bladder sacral neuromodulation intravesical injection of onabotulinum toxin within 9 months

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary Frequency and/or Urinary Incontinence Episodes on 3 day voiding diary | Change from baseline in the median number of urinary frequency and/or urinary incontinence episodes on a 3 day voiding diary at 3, 12, and 24 months | up to 24 months. |
Ablation of Subcutaneous Contraceptive Implants in the Operating Room

Study Overview
=================
Brief Summary
-----------------
The ablation of subcutaneous contraceptive implants is usually performed in consultation under local anesthesia. However, it happens that the implant was placed too deeply or that it migrated too deeply making it impossible to remove it in consultation. These patients should then be referred to reference centers so that the explantation takes place in the operating room. The investigators propose to describe their techniques for preoperative visualization of the implant and their techniques for surgical explantation for educational purposes.

Official Title
-----------------
Technical Description of the Ablation of Subcutaneous Contraceptive Implants in the Operating Room

Conditions
-----------------
Contraceptive Usage

Intervention / Treatment
-----------------
* Procedure: Preoperative visualization techniques


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women over 18 patient who underwent explantation of a subcutaneous contraceptive implant in the gynecology operating room intervention between 2018 and 2022 person having expressed his non-opposition Exclusion Criteria: explantation outside the operating room inability to understand the information given person deprived of liberty person under guardianship

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| subcutaneous contraceptive implants<br>patients who have benefited from explantation of a subcutaneous contraceptive implant in the gynecology operating room | Procedure: Preoperative visualization techniques<br>* describe techniques for pre-operative visualization of subcutaneous contraceptive implants<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ultrasound for visualization of implants | Percentage of patients with an ultrasound to visualize the implants | preoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
subcutaneous contraceptive implants, ablation, operating room
Effect of Mental Stress on Platelet Function in Healthy Subject

Study Overview
=================
Brief Summary
-----------------
Psychological stress is an independent cardiovascular risk factor. Activation of platelets plays an important role in atherosclerosis development and it could one of the mechanisms linking psychological stress and cardiovascular diseases

Official Title
-----------------
Effect of Mental Stress on Platelet Function in Healthy Subject

Conditions
-----------------
Healthy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Healthy subjects No smokers Written informed consent Exclusion criteria: Smoking Alcohol- or Drug Abuse Pregnancy Use of benzodiazepins, Aspirin or NSAIDs in the last week before inclusion Participation to another study within the last month

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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
-----------------
mental stress, cardiovascular risk factor, platelet adhesion
Safety, Tolerability, Pharmacokinetics, and Food Effect of BLU-782 in Healthy Adults

Study Overview
=================
Brief Summary
-----------------
The main objectives of this study are to assess the safety, tolerability, pharmacokinetics (PK), and food effect of BLU-782 in healthy adult subjects.

Official Title
-----------------
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose and Food Effect Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BLU-782 When Administered Orally to Healthy Adult Subjects

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

Intervention / Treatment
-----------------
* Drug: BLU-782
* Drug: Placebo
* Drug: BLU-782 taken with food


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Medically healthy Non-smoker Body mass index (BMI) ≥ 18 and ≤ 32 kg/m2 No clinically significant cardiac history No current electrocardiogram (ECG) abnormality Female must not be of childbearing potential Exclusion Criteria: History of or current mental or legal incapacitation or major emotional problems History or current clinically significant medical/psychiatric condition/disease History of any illness that, in the opinion of the Investigator, might impact the results of the study or pose an additional risk to the participant History or current alcoholism/drug abuse History or current allergy to the study drug or a similar drug

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Basic Science
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single ascending doses with BLU-782<br> | Drug: BLU-782<br>* oral capsules<br>|
| Placebo Comparator: Single ascending doses with placebo<br> | Drug: Placebo<br>* oral capsules<br>|
| Experimental: Multiple ascending doses with BLU-782<br> | Drug: BLU-782<br>* oral capsules<br>|
| Placebo Comparator: Multiple ascending doses with placebo<br> | Drug: Placebo<br>* oral capsules<br>|
| Experimental: Food effect of BLU-782 taken with food<br> | Drug: BLU-782 taken with food<br>* oral capsules<br>|
| Experimental: Food effect of BLU-782 taken without food<br> | Drug: BLU-782<br>* oral capsules<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of adverse events (AEs) through Day 8 with a single dose of BLU-782. |  | Baseline to Day 8 | 
| Incidence and severity of adverse events (AEs) through Day 17 with multiple doses of BLU-782 . |  | Baseline to Day 17 | 
| Comparison of the concentration-time profile of BLU-782 in plasma through day 20 when taken with or without food. |  | Baseline to Day 20 |
HDCT and Stem Cell Transplantation for Mantle Cell and Relapsed Low Grade Non-hodgkin's Lymphoma

Study Overview
=================
Brief Summary
-----------------
Low grade lymphoma patients receive R-ICE reinduction therapy followed by allogeneic stem cell transplanation.

Detailed Description
-----------------
Low grade lymphoma patients receive R-ICE reinduction therapy followed by allogeneic stem cell transplanation if they have an HLA matched sibling, or an autologous transplant if they do not.

Official Title
-----------------
High Dose Chemotherapy and Autologous or Allogeneic Blood Stem Cell Transplantation for Mantle Cell and Relapsed Low Grade Non-hodgkin's Lymphoma

Conditions
-----------------
Low Grade Lymphoma

Intervention / Treatment
-----------------
* Procedure: stem cell source


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: indolent histology lymphomas after relapse 1 or 2 LVEF > 50% Creatinine < 150 umol/L bilirubin < 30 umol/L wbc >3.5X10^9/L platelets >100X10^9/L other medical condition as controlled Exclusion Criteria: pregnant lactating HIV positive CNS involvement by lymphoma other malignancy

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: stem cell source|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| feasibility |  |  | 
| mortality |  |  | 
| overall survival |  |  | 
| event free survival |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
autologous and allogeneic stem cell transplantation, low grade lymphoma, mantle cell
Effectiveness of Standing Frame on Constipation in Children With Cerebral Palsy

Study Overview
=================
Brief Summary
-----------------
Children with Cerebral Palsy and quadriplegia or severe diplegia suffer from highly reduced mobility and consequent constipation. Clinicians frequently recommend standing-frames to exercise the support reaction in this population, sharing the opinion that the upright position may facilitate intestinal transit, although no evidence supports this assumption. The investigators conducted this single-subject research to determine the effects of the standing-frame on the frequency of evacuation in chronically constipated children with CP and quadriplegia. Moreover, the investigators studied its effects on the frequency of induction of evacuation, the characteristics of the stool and the pain suffered by the child due to constipation and/or evacuation.

Official Title
-----------------
Effectiveness of Standing Frame on Constipation in Children With Cerebral Palsy: a Single Subject Study

Conditions
-----------------
Cerebral Palsy, Quadriplegia, Diplegia, Constipation

Intervention / Treatment
-----------------
* Device: standing-frame


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria were: clinical indication for the use of the standing-frame; constipation problems as defined by guidelines (Clinical Practice Guideline, 2006); whose parents gave the informed consent to let their child to participate in this study. Exclusion criteria were: children who have orthosympathetic reactions to the upright position, skeletal deformities and/or medical conditions that, according to clinical judgment, advise against the use of the standing frame.

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 17 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 |
| --- | --- |
| constipated quadriplegic CP children<br>In this study we included children with CP, in the manifestation of severe diplegia or quadriplegia, who do not currently use the standing-frame. | Device: standing-frame<br> <br> * Other names: stander;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bowel evacuation frequency | Using a daily-diary where the caregivers collect the data about the bowel evacuation frequency | 14 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bowel evacuation inductions frequency | Using a daily-diary where the caregivers collect the data about the bowel evacuation inductions frequency | 14 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Standing-frame, Chronic constipation, Cerebral palsy, Quadriplegia, Severe diplegia
Assessing Uterine Ultrasound Done as a Diagnostic Tool for the Depth of Carcinoma Invasion

Study Overview
=================
Brief Summary
-----------------
In this study the investigators aim to assess the diagnostic performance of intraoperative, ultrasonographic assessment of the surgical extracted uterus for determining myometrial invasion's depth in comparison to preoperative ultrasound, intraoperative gross inspection and final pathological report (gold standard). The investigators hope that intraoperative gross inspection of the extracted uterus might offer an additional intraoperative tool for assessing the need for pelvic lymphadenectomy in early stage of endometrial cancer at least as good as pathological exam.

Official Title
-----------------
Assessing the Ultrasound Done on a the Uterus After Hysterectomy as a Diagnostic Tool for the Depth of Endometrial Carcinoma Invasion Into the Myometrium

Conditions
-----------------
Endometrial Endometroid Carcinoma

Intervention / Treatment
-----------------
* Device: Intraoperative ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient's age is 18 or above Patient has been scheduled to undergo hysterectomy (laparoscopic or abdominal) for the staging and treatment of endometrial cancer (endometrioid subtype) and with the relevant suspected symptoms. Patient able to understand,read and sign informed consent. Patient is not participating in other medical trials at present or in the past 30 days Exclusion Criteria: Age under 18 years Patients assessed preoperatively to be at stage 2 and higher endometrial carcinoma Subjects which their biopsy in the pre operating process will include high risk cell types: Grade 3 endometrioid adenocarcinoma, clear cell carcinoma papillary serous carcinoma carcinosarcoma

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endometrial carcinoma patient<br> | Device: Intraoperative ultrasound<br>* Diagnostic intraoperative ultrasound in the uterus after hysterectomy for assessing depth of tumor invasion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor invasion | Tumor invasion (in millimeters and in percentage of myometrial size) as assessed by ultrasound in comparison to macroscopic assesment during surgery and to final pathological report) | Average of 2 weeks (immediate assessment by ultrasound, average of 2 weeks for final pathological report) |
Evaluation of Right Ventricular Function Post Mitral Valve Operations

Study Overview
=================
Brief Summary
-----------------
We aim to determine the function of Right ventricle post mitral valve surgeries in patients with pulmonary hypertension using transthoracic echocardiography3- and 6-months post-operatively to detect the effect of mitral valve surgeries over the RV function whether improving, deteriorating, or not changing at all.

Official Title
-----------------
Evaluation of Right Ventricular Function Post Mitral Valve Operations in Patients With Pulmonary Hypertension.

Conditions
-----------------
Right Ventricular Dysfunction

Intervention / Treatment
-----------------
* Device: Echocardiography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who underwent mitral valve surgeries who also had pulmonary hypertension in the period between March 2019 and March 2022 in Assiut university heart hospital Exclusion Criteria: Patients who underwent mitral valve surgeries with normal pulmonary pressure. Patients who had other valve surgeries besides mitral as aortic and/or tricuspid valve surgeries. Patients had mitral valve surgeries with other heart conditions that needed another intervention in the same session as CABG for IHD.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Echocardiography|Echocardiography 3 and 6 months post operative|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Right Ventricular function post mitral valve surgeries in patients with pulmonary hypertension | to detect right ventricular function (ejection fraction percentage and/or TAPSE) through transthoracic echocardiography 3- and 6-months post operatively in patients who had mitral valve surgeries with pulmonary hypertension. | From March 2019 till March 2022 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best mitral valve surgical modalities in patients with pulmonary hypertension | to identify best surgical modalities for mitral valve diseased patients with pulmonary hypertension that lead to improvement of right ventricle function. | From March 2019 till March 2022 |
in Vivo TICE (TransIntestinal Cholesterol Excretion)

Study Overview
=================
Brief Summary
-----------------
So far, the liver has been the main target for cholesterol elimination. However, several recent studies performed in mice have described a new route of cholesterol excretion, the Trans-Intestinal Cholesterol Excretion or TICE. TICE allows direct elimination of plasma cholesterol in the feces directly via the intestine. Until now, only indirect evidence suggests that TICE is also active in humans, the goal of this proof of concept study is to provide the first proof of its existence in humans by using stable isotopes in patients with bile duct diversion.

Official Title
-----------------
In Vivo TICE (TransIntestinal Cholesterol Excretion) Measurement in Bile Duct Diverted Patients

Conditions
-----------------
Occlusion of Bile Duct With an External Bile Diversion.

Intervention / Treatment
-----------------
* Other: Intravenous injection of deuterated cholesterol diluted in intralipid 20%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - External bile duct diverted patients Exclusion Criteria: Inflammatory bowel disease Aphagia Renal or hepatocellular insufficiency Primary intestinal tumor Cholangitis or severe sepsis Acute or chronic diarrhea

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Trans-intestinal cholesterol excretion in vivo<br>Measuring trans-intestinal cholesterol excretion in vivo in bile diverted patients | Other: Intravenous injection of deuterated cholesterol diluted in intralipid 20%<br>* At day 0, bile diverted patients will receive an intravenous injection of deuterated cholesterol diluted in intralipid 20%. The plasma, biliary and fecal content of deuterated cholesterol will be measured, by mass spectrometry, at 24, 48 and 72 hours after the initial input.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measuring trans-intestinal cholesterol excretion in vivo in bile diverted patients | Measuring trans-intestinal cholesterol excretion in vivo in bile diverted patients | Day 3 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TICE-human-stable isotopes