linjc16/ctgov huggingface dataset:
Mode of Uterine Extraction in Total Laparoscopic Hysterectomy

Study Overview
=================
Brief Summary
-----------------
Hysterectomy remains the most common major gynecological operation worldwide. It may be carried out by three different routes and its variations: vaginal, abdominal, and laparoscopic. A large uterus will lead to several surgical difficulties during laparoscopic hysterectomy, such as limited operative field, restrictive instrument range of motion, and difficult removal of the specimen. The aim of this study was to compare the clinical results of TLH for large uterus through transvaginal or uterine morcellation approaches after strict preoperative assessment.

Official Title
-----------------
Predictive Factors for Mode of Extraction of the Uterus in Total Laparoscopic Hysterectomy

Conditions
-----------------
Hysterectomy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing total laparoscopic hysterectomies for larger uteri Exclusion Criteria: oncology

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative complications | mean operation time, uterus removal time, blood loss | During surgery | 
| Post operative complications | Pelvic hematoma, vaginal stump infection, lower limb venous thrombosis | 30 days after surgery |
Evaluation of Practices at the University Hospital of Nancy in the Context of Surgery During Pregnancy

Study Overview
=================
Brief Summary
-----------------
About 2% of pregnant women are going through from surgery during pregnancy. These are mainly represented by emergencies like abdominal conditions such as appendicitis. Pregnancy raises the issue of possible diagnostic confusion associated with operational difficulties related to a gravid uterus, i.e. increased in volume, and possible induced obstetric complications like premature delivery or miscarriage. late. The management of these patients is therefore complex and the literature is poor on the subject.

Detailed Description
-----------------
In the CHRU of Nancy because of the lack of guidelines, there is no guidelines on the management around urgent surgery during pregnancy. The aim is to describe how patients on the 7 last years where taking care of and to examine if there where mistakes and delay due to pregnancy.' The aim is also to describe the consequences of the surgery and analyse the end of the pregancy

Official Title
-----------------
Evaluation of Practices at the University Hospital of Nancy in the Context of Surgery During Pregnancy :a Retrospective Study Between 2014 and 2021

Conditions
-----------------
Surgery, Pregnancy Complications, Pregnancy Related

Intervention / Treatment
-----------------
* Procedure: abdominal surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women going through pregnancy Exclusion Criteria: -
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients<br>Women undergo pregnancy from 5 SA to 41 SA with no limitation of age | Procedure: abdominal surgery<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with no mistakes from the diagnosis to the surgery. | days of delay in the diagnosis ? error ? Diagnostic of certitude is established during surgery | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact on pregnancy | The impact on pregnancy is defined as the issues after surgery such as miscarries, premature labor, neonatal asphyxie etc.. | 1 year |
Study to Evaluate Pharmacokinetics, Safety and Efficacy of CM310

Study Overview
=================
Brief Summary
-----------------
This is a single-center, randomized, open study to evaluate the pharmacokinetics, safety and immunogenicity CM310 in healthy subjects.

Detailed Description
-----------------
This study includes screening and treatment and follow-up periods.

Official Title
-----------------
A Randomized, Open, Parallel Phase I Clinical Study on the Comparison of Pharmacokinetics Characteristics of CM310 Recombinant Humanized Monoclonal Antibody Injection in Healthy Subjects

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

Intervention / Treatment
-----------------
* Biological: CM310


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have the ability to understand the study. Voluntarily participate in the study and sign the ICF. 18 years ≤ age ≤ 65 years, male and female. Willing to take effective contraceptive measures during the study period. Exclusion Criteria: Plan to receive any major surgery during the study period. With malignant tumors within 5 years before screening. Positive results of alcohol breath test or urine drug abuse screening during screening period. Any reason that the investigator believes that will prevent the subject from participating in the study.

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group P1<br>CM310, Subcutaneous | Biological: CM310<br>* CM310 Recombinant Humanized Monoclonal Antibody Injection<br>|
| Active Comparator: Group P2<br>CM310, Subcutaneous, as the parallel control group | Biological: CM310<br>* CM310 Recombinant Humanized Monoclonal Antibody Injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic: the maximum concentration (Cmax) | Concentration and exposure | up to 57 days |
Modern Urodynamics System Efficacy (MUSE) Study

Study Overview
=================
Brief Summary
-----------------
The goal of this prospective observational trial is to evaluate the feasibility, efficacy, and safety of the Glean Urodynamics System (GUS) for use in the clinic to collect vesical pressure data in adult males and females with lower urinary tract symptoms. The main question[s] it aims to answer are: • What is the feasibility, efficacy, and safety of GUS for use in clinical to collect vesical pressure data in adult males and females with lower urinary tract symptoms? Participants will undergo a planned conventional urodynamics exam after which the Glean Sensor will be inserted and ambulatory urodynamics will be performed with the sensor indwelling in the bladder after which the sensor will be removed.

Official Title
-----------------
Modern Urodynamics System Efficacy (MUSE) Study

Conditions
-----------------
Urologic Diseases, Urodynamics

Intervention / Treatment
-----------------
* Device: Glean Urodynamics System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patient must be ≥ 18 years of age Patient must have a diagnosis of LUTD Patient must be scheduled for or recommended for cUDS Patient is able to tolerate 18Fr catheterization Patient or patient's legally authorized representative is able to provide informed consent Exclusion Criteria: Pregnant (as confirmed by urine pregnancy test) or breastfeeding, pregnant within the past 6 months or intend to become pregnant during the study period. Patient has a symptomatic UTI based on CDC guidance (see below) Subjects who, at the principal investigator's determination, would not be appropriate for this study.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Glean Urodynamics System<br>Wireless, catheter-free urodynamics system | Device: Glean Urodynamics System<br>* Wireless, catheter-free urodynamics system<br>* Other names: GUS;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insertion/Removal Success | Percent of insertion or removal attempts of the Glean sensor deemed successful | during the procedure/surgery | 
| Device-related SAE | Device-related serious adverse events | up to 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient perception | Likert scale of comfort during Glean urodynamics; scale 1-5, higher scores are better | during the procedure/surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lower Urinary Tract Dysfunction, Urinary Incontinence, Overactive Bladder, Urodynamics, Uroflowmetry
Exploring Radiotherapy of Temporomandibular Joint Arthritis

Study Overview
=================
Brief Summary
-----------------
With this pilot study, the acute side effects and potential pain relieve after radiotherapy (RT) of the temporomandibular joint (TMJ) are prospectively recorded. For this purpose, the symptoms of the jaw joint arthrosis/arthritis are recorded using a symptom-oriented questionnaire and the numeric rating scale for pain assessment. Furthermore, it is examined whether the irradiation is feasible.

Official Title
-----------------
Exploring Radiotherapy of Temporomandibular Joint Arthritis

Conditions
-----------------
Arthritis of Temporomandibular Joint

Intervention / Treatment
-----------------
* Radiation: Irradiation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: TMJ arthritis diagnosed by a surgeon for oral and maxillofacial surgery or a dentist Exclusion Criteria: Previous irradiation in the TMJ area Age below 50 years

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 100 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: TMJ RT<br>Patients receiving irradiation to the TMJ | Radiation: Irradiation<br>* 3 Gy in 6 fractions to the TMJ, every other day, LINAC based<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| therapeutic effect | Pain, Numeric rating scale (0-10, 0=no pain, 10=maximum pain) | Before, directly after treatment and after 3, 6 9 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other temporomandibular joint conditions | Questionnaire (covering the condition of the temporomandibular joint and masticatory muscles, Version: 12.03.2018 (FB II) of the University of Leipzig) | Before, directly after treatment and after 3, 6 9 and 12 months |
Optimal Stimulation Parameters to Disrupt Epileptiform Activity

Study Overview
=================
Brief Summary
-----------------
Open-loop electrical stimulation has been found to reduce spike activity and seizures, but determining the optimal parameters to achieve these effects requires a brute force trial-and-error approach that relies on subjective physician discretion. We will compare the performance of stimulation parameters identified in rodent models to the recommended parameters for neuromodulation used in clinical practice.

Official Title
-----------------
Optimal Stimulation Parameters for Spike-ripple Disruption in Patients Undergoing Invasive Monitoring

Conditions
-----------------
Refractory Epilepsy

Intervention / Treatment
-----------------
* Other: Neurostimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Undergoing intracranial EEG investigation at Massachusetts General Hospital during presurgical epilepsy evaluation - Exclusion Criteria: Baseline spike ripple rate < 0.5/min. -
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Neurostimulation|Electrical stimulation|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spike ripple rate |  | 1-3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spike rate |  | 1-3 hours |
The Use of a Minimally Invasive Internal Fixation Device for Treatment of Unstable Pelvic Ring Fractures

Study Overview
=================
Brief Summary
-----------------
Pelvic fractures are common presentations to major trauma centers and are associated with significant morbidity in polytrauma patients. Traditional open reduction and internal fixation is associated with a high incidence of surgical morbidity, while external fixators, used for both temporary stabilisation and as definitive management, have a complication rate of up to 62% [4], with poor patient tolerance, pin site infection and aseptic loosening the more commonly documented complications in the literature. Minimally invasive techniques have become more popular recently in the management of pelvic injuries due to their lower incidence of surgical morbidity. The application of a pelvic internal fixator (INFIX) has been presented as a comparable alternative to external fixation of anterior pelvic ring injuries.

Official Title
-----------------
The Use of a Minimally Invasive Internal Fixation Device for Treatment of Unstable Pelvic Ring Fractures

Conditions
-----------------
Unstable Pelvic Fractures

Intervention / Treatment
-----------------
* Procedure: minimally invasive internal fixation device infix


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who had APC-II Patients who had APC-III Patients who had LC - II Patients who had LC -III Exclusion Criteria: Patients who had immature skeletons or medical contraindications such as combined neurovascular injuries and uncontrolled medical diseases. Open fractures. Stable pelvic ring fractures. Patients who had combined acetabular fractures Patients who had a hernia or previous lower abdominal surgery. Pregnancy.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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

| Intervention/Treatment |
| --- |
|Procedure: minimally invasive internal fixation device infix|An INFIX involves the insertion of spinal pedicle screws in the anterior pelvis (supra-acetabular entry) and the placement of a connecting rod in the subcutaneous tissue of the patient|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| advantages using INFIX | good patient tolerance | 6 months | 
| union | radiological | 1 yea |
Non-Eosinophilic Biological Effects of IL-5

Study Overview
=================
Brief Summary
-----------------
This study aims to investigate the role of IL-5 in suppressing anti-viral immune responses in bronchial epithelial cells (BECs) and in peripheral blood mononuclear cells (PBMCs) from 5 people with asthma.

Detailed Description
-----------------
IL-5 has been shown to be present in higher levels in those with asthma, more so during viral infection. The investigators know from existing evidence that having increased levels of interferon (IFN) reduces asthma exacerbations and viral load. The investigators suspect that IL-5 reduces the immune response during viral infection in bronchial epithelial cells (BECs) and peripheral blood mononuclear cells (PBMCs) by reducing levels of IFN. The aim is to investigate if increased IL-5 in stable eosinophilic asthma and asthma exacerbations suppresses anti-viral immunity in bronchial epithelial cells and in peripheral blood mononuclear cells directly via IL-5 receptor signalling, suppressing rhinovirus induction of IFNs. The investigators also will evaluate if anti-IL-5 therapies suppress IL-5 concentrations in stable and exacerbated asthma in vivo and whether suppression of IL-5 in vivo restores deficient anti-viral immunity in BECs and PBMCs, thereby protecting against asthma exacerbations.

Official Title
-----------------
Non-Eosinophilic Biological Effects of Interleukin 5 (IL-5) - Role of IL-5 in Suppressing Anti-Viral Immunity in Bronchial Epithelial Cells and Dendritic Cells in Asthma

Conditions
-----------------
Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Must be eligible for the study 'Mechanisms of Adverse Effects of Long-Acting Beta-Agonists in Asthma' (MAELABA) (19SM5101).

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 |
| --- | --- | --- |
| IL-5 suppresses anti-viral immunity in BECs and in PBMCs/pDCs directly via IL-5 receptor signalling suppressing RV induction of IFNs. | Expression of IL-5RA, CSF2RB and IFN mRNA and protein in BECs and PBMCs will be measured at baseline and following rhinovirus infection.Viral load will be measured by PCR(copies/ml) of viral RNA in cell lysates and virus release into supernatants by TCID50 assay to determine whether IL-5 augments virus replication. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Interleukin 5, Bronchial epithelial cells, Peripheral blood mononuclear cells, Peripheral dendritic cells, Interferon, Rhinovirus
Pain Perception by the Chronic Renal Patient at the Time of Vascular Access Cannulation.

Study Overview
=================
Brief Summary
-----------------
Pain in patients under hemodialysis affects chronic renal patients' quality of life. Distraction has been effective in controlling pain induced by the insertion of needles. Once applied adequately, distraction promotes endorphins' release, with efficacy in acute pain. This study aims to evaluate pain perception while puncturing the hemodialysis device using an anti-stress ball as a distraction strategy.

Official Title
-----------------
Pain Perception by the Chronic Renal Patient at the Time of Vascular Access Cannulation - a Randomized Trial

Conditions
-----------------
Renal Dialysis

Intervention / Treatment
-----------------
* Behavioral: Distraction technique


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults over 18 years old able to read and write vascular access by a fistula or arteriovenous prosthesis, cannulated with a 15G needle vascular access at least with month old Exclusion Criteria: patients under 18 years can't be able to read and/or write usage of topical anesthetics before treatment vascular access by a fistula or arteriovenous prosthesis, cannulated with smaller or larger 15G needles vascular access under one-month-old

Ages Eligible for Study
-----------------
Minimum Age: 62 Years
Maximum Age: 77 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Distraction technique<br> | Behavioral: Distraction technique<br>* Distribution of an anti-stress ball before the moment of cannulation of the vascular access and instructing to place it in hand opposite the limb of the vascular access<br>|
| No Intervention: Pain monitor<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain perception by hemodialysis patients | Assess the perceived pain by chronic kidney disease patients at the time of vascular access cannulation for hemodialysis, by a pain scale. On the intervention group was used a distraction technique, using an anti-stress ball, at weeks 7-12. On the control group there was only the measurement of pain by scale. | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Arteriovenous Fistula, Renal Insufficiency Chronic, Quality of Life, Distraction