cyrilzakka/clinical-trials huggingface dataset:
Outcome After Multidisciplinary CO2 Laser Laparoscopic Excision of Deep Infiltrating Colorectal Endometriosis

Improved pain, sexuality and quality of life, high fertility and low complication and recurrence rates after multidisciplinary CO2 laser laparoscopic excision of deep infiltrating colorectal endometriosis.

All women (n=56) who had undergone CO2 laser laparoscopic radical excision of deep infiltrating endometriosis with active involvement of colorectal surgeon and/or urologist were selected retrospectively from the list of all patients (n=more than 2000) operated at the Leuven University Fertility Centre (LUFc) between September 1996 and July 2004.

All 56 multidisciplinary operated patients were asked to complete the Oxford Endometriosis Quality of Life questionnaire, a sexual activity questionnaire and visual analogue scales (VAS) for dysmenorroe, chronic pelvic pain and deep dyspareunia, to compare their status before surgery and at the moment of the evaluation (January 2005).

Eligibility Criteria:
Inclusion Criteria:

* All women (n=56) who had undergone CO2 laser laparoscopic radical excision of deep infiltrating endometriosis with active involvement of colorectal surgeon and/or urologist
* operated at the Leuven University Fertility Centre (LUFc) between September 1996 and July 2004

Exclusion Criteria:

* Women who had undergone CO2 laser laparoscopic excision of deep infiltrating endometriosis without active involvement of colorectal surgeon and/or urologist
Aerobic Training, Aerobic-resistance Training and Glucose Profile (CGMS) in Type 2 Diabetes

Many studies were already performed showing beneficial cardiovascular and metabolic effects of physical training for type 2 diabetic patients. However, glucose profile during and immediately after a short period of aerobic and/or resistance training was not studied yet. Continuous glucose monitoring system (CGMS) has now been added to the repertoire of technological devices useful in the management of patients with diabetes. Such monitoring enables clinicians to detect occult hypoglycemia and hyperglycemia not otherwise discernable with intermittent testing of blood glucose. The main aim of the present study is to investigate continuous blood glucose profile (using CGMS) over 72h, beginning 24h before and ending 24h after a single bout of aerobic or aerobic/resistance physical training in type 2 diabetic patients.

Many studies were already performed showing beneficial cardiovascular and metabolic effects of physical training for type 2 diabetic patients. However, glucose profile during and immediately after a short period of aerobic and/or resistance training was not studied yet. Continuous glucose monitoring system (CGMS) has now been added to the repertoire of technological devices useful in the management of patients with diabetes. Such monitoring enables clinicians to detect occult hypoglycemia and hyperglycemia not otherwise discernable with intermittent testing of blood glucose. The main aim of the present study is to investigate continuous blood glucose profile (using CGMS) over 72h, beginning 24h before and ending 24h after a single bout of aerobic or aerobic/resistance physical training in type 2 diabetic patients.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetic patients treated with diet and metformin, 35-65 years old

Exclusion Criteria:

* Type 1 diabetic patients
* Treatment with insulin or sulphonylureas or glitazones
* Proliferative retinopathy
* Severe autonomic neuropathy
* Coronary artery disease
* Baseline fasting plasma glucose\>200 mg/dl
* Peripheral artery disease
* Amputation
* Heart failure
* Diabetic nephropathy
* Renal failure
CoolSculpting in the Abdomen Using Applicator With and Without CCI

Evaluate the safety and efficacy of non-invasive subcutaneous fat layer reduction in the abdomen using an applicator with the Crown Cooling Insert.

Evaluation of CoolSculpting treatment in the abdomen using a vacuum applicator with an accessory insert.

Eligibility Criteria:
Inclusion Criteria

* Male or female subjects \>22 years of age and \< 65 years of age.
* Subject has clearly visible fat on the abdomen, which in the investigator's opinion, may benefit from the treatment.
* Subject is a candidate for a standard CoolSculpting treatment with a CoolMax applicator.
* No weight change exceeding 5% of body weight in the preceding month.
* Subject agrees to maintain his/her weight (i.e., within 5%) by not making any major changes in their diet or exercise routine during the course of the study.
* Subject has read and signed the study written informed consent form. Exclusion Criteria
* Subject has had a surgical procedure(s) in the area of intended treatment.
* Subject has had an invasive fat reduction procedure (e.g., liposuction, mesotherapy) in the area of intended treatment.
* Subject has had a non-invasive fat reduction and/or body contouring procedure in the area of intended treatment within the past 12 months.
* Subject needs to administer, or has a known history of subcutaneous injections into the area of intended treatment (e.g., heparin, insulin) within the past month.
* Subject has a known history of cryoglobulinemia, cold urticaria, cold agglutinin disease or paroxysmal cold hemoglobinuria.
* Subject has a known history of Raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin.
* Subject has a history of bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising.
* Subject is taking or has taken diet pills or supplements within the past month.
* Subject has any dermatological conditions, such as moderate to excessive skin laxity, or scars in the location of the treatment sites that may interfere with the treatment or evaluation (stretch marks is not an exclusion).
* Subject has an active implanted device such as a pacemaker, defibrillator, or drug delivery system or any other metal containing implant.
* Subject is pregnant or intending to become pregnant during the study period (in the next 5 months).
* Subject is lactating or has been lactating in the past 6 months.
* Subject has a history of hernia in the areas to be treated.
* Subject is unable or unwilling to comply with the study requirements.
* Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
* Subject is prone to severe claustrophobia (during MRI scans).
* Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.
New Lung Ventilation Strategies Guided by Transpulmonary Pressure in VV-ECMO for Severe ARDS

Extracorporeal membrane oxygenation (ECMO) has been widely used in patients with severe acute respiratory distress syndrome (ARDS). But how to choose mechanical ventilation strategy is still not clear for severe ARDS patients supported by ECMO. Our previous work found that, compared to the traditional "lung rest" strategy, transpulmonary pressure guide new lung ventilation strategy can better maintain lung volume reduction lung collapse, atelectasis occurs. The severe ARDS patients receiving ECMO therapy were randomized divided into a new ventilation strategy group and the conventional ventilation strategy group. The new ventilation strategy is transpulmonary pressure guide ventilator setting method, and the conventional ventilation strategy is Extracorporeal Life Support Organization (ELSO) guide ventilation method. Compare the difference between the two groups of patients in lung injury, and explore the lung protection mechanism of new lung ventilation strategies guided by transpulmonary pressure. Our research group considered that transpulmonary pressure guide new lung ventilation strategy can provide more effective lung protection. And it will be further used in clinical work.


Eligibility Criteria:
Inclusion Criteria:

* ARDS cause reversible;
* Pure oxygen is given, but PaO2/FiO2\<80;
* P(A-a)O2\>600mmHg;
* Murray score≥3.0;
* pH\<7.2;

Exclusion Criteria:

* peak inspiratory pressure\>30cmH2O;
* high FiO2\>0.8;
* ventilation\>7 days;
* contraindication to heparinization;
* non-reversible central nervous system injury
* chronic disease with a short life expectancy
A Study to Estimate Effect of 4 Different Doses of AZD3355 on Reflux Episodes, Which Patients With Gastroesophageal Reflux Disease (GERD) May Experience

The purpose of the study is to estimate what effect 4 different doses of AZD3355 will have on the number of reflux episodes, in patients who have GERD and still experience symptoms despite proton pump inhibitor (PPI) treatment.


Eligibility Criteria:
Inclusion Criteria:

* Provide informed consent
* History of GERD with persistent symptoms despite treatment with PPI
* Otherwise normal physical health

Exclusion Criteria:

* History of GERD with symptoms that has not improved at all during treatment with PPI
* Prior surgery of the upper gastrointestinal tract
* History of significant heart disease, cardiovascular, respiratory, hepatic, renal, metabolic, psychiatric or gastrointestinal disorders besides GERD
Effect of Continuous Positive Airway Pressure (CPAP) on Hypertension and Cardiovascular Morbidity-Mortality in Patients With Sleep Apnea and no Daytime Sleepiness

The objective of the study is to evaluate the effect of CPAP over the incidence of cardiovascular events and diagnosis of arterial hypertension in patients with sleep apnea.

The hypothesis of the study is the following: The existence of sleep disordered breathing in the general population is associated to an increased incidence of arterial hypertension and to an increased risk of suffering cardiovascular disease. CPAP corrects respiratory disorders during sleep. Treatment with CPAP in subjects with sleep disordered breathing without daytime sleepiness reduces the incidence of systemic arterial hypertension and cardiovascular complications.

The end points of the study are new diagnosis of arterial hypertension and new cardiovascular events.

All patients, after randomization, will be followed for three years.


Eligibility Criteria:
Inclusion Criteria:

* Epworth \<10
* Apnea-Hypopnea Index ≥20

Exclusion Criteria:

* Presence of any chronic disease
* Presence of cardiovascular disease
* Refusal to sign informed consent
* Drug addiction and/or alcoholism
Duration of Stay After Urologic Surgery : Neuraxial Versus General Anesthesia

Outpatient midurethral surgery is a frequent surgery. It is performed either under general anesthesia or neuraxial anesthesia. A frequent complication is postoperative urinary retention requiring urinary catheterization, which implies a higher infectious risk.

The investigators compared the complication rate after TVT surgery depending on the type of anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Sex: Female
* Patient who has consented to the use of her medical data for research purposes.
* Patient undergoing outpatient urinary incontinence surgery using TVT between 2012 and 2016

Exclusion Criteria:

* Specific clinical forms of the disease,
* Interfering treatments and associated diseases, history,
* Refusal of the patient to participate in the study
A Comparative Study of Hall Technique, Modified Hall Technique and Conventional Stainless-Steel Crown Restorations in the Treatment of Primary Molars With Proximal Caries Lesions.

The purpose of this study is to compare the effectiveness of the Hall technique and modified Hall technique to the conventional Stainless-Steel Crown restoration in the treatment of primary molars with dentinal caries with or without proximal ridge intact.


Eligibility Criteria:
Inclusion Criteria:

* Medically fit children
* Children who exhibit cooperative behavior at initial bitewing radiograph procedure
* Children with symptom-free or reversible pulpitis restorable first and second primary molars in both arches
* Teeth with D1 lesions will be included
* No periapical or furcation pathologies on bite wing radiographs

Exclusion Criteria:

* Medically compromised children
* Children with uncooperative behavior during bitewing radiograph process
* Primary molars with irreversible pulpitis
* Teeth with furcation or peri radicular pathologies
Comparing Exenatide and Insulin Glargine in Type 2 Diabetes Patients for Whom Insulin is the Next Appropriate Therapy

This is a study with two treatment sequences and two treatment periods that will assess the safety and efficacy of exenatide treatment in patients with type 2 diabetes who have inadequate glycemic control using metformin or sulfonylurea and for whom insulin is the next appropriate step in diabetes treatment.


Eligibility Criteria:
Main Inclusion Criteria:

* Treated with a stable dose of metformin or sulfonylurea for at least 3 months prior to screening.
* HbA1c between 7.1% and 11.0%, inclusive.
* Insulin therapy should be the next appropriate step of diabetes treatment.
* Body Mass Index (BMI) \>25 kg/m2 and \<40 kg/m2.

Main Exclusion Criteria:

* Patient previously in a study involving exenatide or glucagon-like peptide-1 analogs.
* Treated with insulin, thiazolidinediones, alpha-glucosidase inhibitors, or meglitinides within 3 months prior to screening.
Effect of Recombinant Human Granulocyte Colony- Stimulating Factor on CD11b in Septic Neonates

The investigators aimed to evaluate the effect of G-CSF administration in septic neonates on neutrophil production and CD11b expression.

Neonates are susceptible to septicemia secondary to quantitative and qualitative neutrophilic defects. Granulocyte-colony stimulating factor (G-CSF) stimulates myeloid progenitor cell proliferation and induces selective neutrophil functions.

Eligibility Criteria:
Inclusion Criteria:

* newborn infants with postnatal age \< 28 day,
* minimum gestational age of 28 weeks and requiring intensive care with clinical signs consistent with the diagnosis of neonatal sepsis,
* with or without neutropenia

Exclusion Criteria:

* neonates with congenital malformation,
* major chromosomal abnormalities,
* prior use of cytokines or intravenous immunoglobulin, or decreased hemoglobin and/or hematocrit at or below the levels necessitate transfusion
The Effect of Whey Protein Consumption on Hypoglycemia in Adults with Type 1 Diabetes During Fasting Ramadan.

Cross over randomized design for adding whey protein to Suhoor meal for patients with T1DM during fasting Ramadan

Patients with type1 diabetes who intend to fast will be supplied with dietary supplement "Whey protein" to be taken with Suhoor (predawn meal) for one week during Ramadan. They will be then crossed over to not taking the whey protein for another week. the order of taking whey protein will be randomized.

During both weeks patients will be monitored through flash continuous glucose monitoring and data will be compared in regards to incidence and timing of hypoglycemia, hyperglycemia, and time in target range.

After Ramadan data will be collected on number of days they had to brake fast due to low blood sugar during both weeks and overall satisfaction with using whey protein during Ramadan.

Eligibility Criteria:
Inclusion Criteria:

1. Type 1 Diabetes Mellitus
2. Age \>14 years
3. Committed to do Regular SMBG or on CGM
4. On Multiple Daily Injections or insulin pumps
5. On carbohydrate counting for meal dosing
6. Have previously fasted Ramadan
7. willing to fast Ramadan this year
8. Well-educated about requirements for fasting Ramadan

Exclusion Criteria:

1. Hypoglycemia unawareness
2. Cognitive impairment or learning disability
3. Renal and hepatic impairment
4. Adrenal insufficiency
5. Pregnancy
6. Alcohol consumption
7. Any diagnosed psychiatric disease
8. Sensor-augmented insulin pumps
9. HbA1c \>12%
10. Already on protein supplements
Clinical Outcomes of Autologous Bone Marrow Aspirate Concentrate Injections for Musculoskeletal Conditions

The use of Bone Marrow Autologous Collection (BMAC) in musculoskeletal conditions including osteoarthritis and tendon injuries has been growing. Outcome evidence continues to be sparse. The purpose of this study is collect a longitudinal case series of patient reported outcomes following BMAC injections for musculoskeletal conditions including osteoarthritis, tendinopathy and injuries to ligaments, tendons and muscles.


Eligibility Criteria:
Inclusion Criteria:

* Musculoskeletal Condition that is able to undergo an injection
* Patient requests the procedure and enrolls with agreement to pay for the procedure

Exclusion Criteria:

* Active Cancer
* Allergies to local anesthesia
The Effect of Silicone Suspension on Standing Balance for Transfemoral Amputees

The objective of this study is to test the hypothesis that silicone suction suspension without additional belt support does not significantly diminish the postural sway or walking performance of persons with transfemoral amputation.


Eligibility Criteria:
Inclusion Criteria:

* be forty-five (45) or older;
* unilateral transfemoral amputee;
* current patients of the QEII Health Sciences Centre Amputee Service based at the Rehab Site;
* can walk comfortably with their prosthesis for a minimum of 5 minutes, regardless of whether they require ambulation aids (i.e. canes, walkers, etc.);
* are in the process of being fitted with a silicon suction liner and pin system;
* are competent to give informed consent or have a proxy with power of attorney;
* have the written permission of the attending physician to participate;
* be willing to take part in the study, including signing the consent after carefully reading it.

Exclusion Criteria:

* have an unstable medical condition (e.g. angina, seizures), as determined by the attending or house physician;
* have major medical or neurological conditions that affect balance (specifically Parkinson's disease, stroke or Multiple Sclerosis), as determined by the physician or house staff physician;
* have an emotional or psychiatric problem of a type or extent that might make participation unpleasant, as determined by the attending or house physician.
Randomized Controlled Trial of Standard ERP and OC-Go

Phase II of this study will examine the efficacy of the OC-Go application via a randomized controlled trial comparing standard exposure and response prevention (ERP) treatment for pediatric obsessive compulsive disorder (OCD) to exposure/response prevention (ERP) augmented with OC-Go. A cross-over design will be implemented for these 12 sessions of treatment, in which participants that were randomized to standard ERP will receive OC-Go augmented ERP for the second half of treatment, and vice versa. Efficacy will be investigated in a sample of 32 children with OCD.

This project seeks to refine and assess OC-Go, a HIPAA-compliant web-based clinician portal and patient-side mobile application designed to increase patient adherence to evidence-based treatment (EBT) for OCD, a common and impairing condition, and provider ability to effectively implement EBTs. OC-Go allows clinicians to create and push tailored assignments to patients on their mobile devices with an optimized user interface that includes patient accountability and support features. Accordingly, patients can be guided to do assignments by themselves between sessions with increased fidelity over the course of treatment. Once therapy assignments are created and shared to a crowd-sourced and curated public library, any clinician can assign any task to any patient for homework or in-session use with one touch. Use of OC-Go is expected to increase patient engagement, compliance, treatment efficiency, dissemination of EBTs, and therapist confidence and expertise.

Eligibility Criteria:
Inclusion Criteria:

* Ages 9-17 years old
* Primary diagnosis of OCD based on diagnostic interview (ADIS)
* CGI-Severity score \> 3

Exclusion Criteria:

* Anti-OCD medication/unstable dose (with changes expected during the study)
* Significant and interfering comorbid psychiatric, psychosocial, neurological, or medical condition (e.g., acute suicidality, low IQ, etc.) precluding the child's ability to complete all study procedures
Is Involucrin Has a Role in Verruca Vulgaris? A Clinical and Immunohistochemical Study

Vitamin D3 plays important role in keratinocyte differentiation and had been used recently in verruca vulgaris. Aim of the work: To assess the expression of involucrin in verrucae vulgaris before and after injection of vitamin D3. Subjects and Methods: This study included 60 patients with verrucae vulgaris subjected to intralesional injection of vitamin D3 at three weeks interval for a maximum of five sessions. Immunohistochemical assessment of involucrin was done before and after injection and compared to skin biopsies from 30 healthy individuals


Eligibility Criteria:
Inclusion criteria:

Patients with multiple verruca vulgaris Patients with with verrucae vulgaris with size more than 3 cm

Exclusion Criteria:

Patients with a past history of allergic response to vitamin D. Pregnant or lactating females. Hepatic patients. Renal patients. Patients with bleeding tendency.
LE as a Marker for Periprosthetic Joint Infection

Testing and comparison of a novel point-of-care electrochemical assay to detect and help diagnose periprosthetic joint infection on the hip and knee to the standard of care test

The primary objective of this study is to assess the equivalence of a semi-quantitative electrochemical leukocyte esterase test system and off-label use of the Roche Chemstrip leukocyte esterase (LE) test for the diagnosis of periprosthetic joint infection (PJI) in synovial fluid from hip and knee joints. In this study, the qualitative outcome of each of the two methodologies for detecting leukocyte esterase enzyme will be compared. The hypothesis of this study is that the two tests will demonstrate equivalence. The leukocyte esterase enzyme level will also be compared to synovial white blood cell count, which will be considered as a secondary reference.

Eligibility Criteria:
Inclusion Criteria:

1. Age greater than 18 years
2. Willing and able to sign the informed consent document
3. Subjects presenting with presumed aseptic failure of a prosthetic joint and expected to undergo revision arthroplasty, or subjects presenting with presumed PJI and expected to undergo either DAIR or radical implant resection, and subjects being investigated for PJI having joint aspiration outside of the operating room who may or may not require surgical intervention.

Exclusion Criteria:

1. Subjects with known active crystalline deposition disease (e.g. gout)
2. Subjects with adverse local tissue reaction (ALTR) as a result of corrosion of components or metal-on-metal bearing surface in the hip
3. Subjects with active inflammatory arthropathy (e.g. rheumatoid arthritis)
4. Subjects undergoing a second-stage re-implantation procedure for PJI
5. Subjects in which standard of care assessments, at a minimum serology (ESR and CRP) and synovial fluid analysis (synovial WBC count, neutrophil percentage, and culture), cannot be performed.
6. Subjects in whom there is an insufficient amount of synovial fluid to perform the required investigational tests.