cyrilzakka/clinical-trials huggingface dataset:
ThermaChoice III Under Local Sedation in the Office Setting

Investigational study to determine if an endometrial ablation for heavy uterine bleeding, can be tolerated in the office setting without the use of intravenous medication.

A safe and effective treatment , called endometrial ablation, has been used in a hospital setting under general anesthesia for the treatment of heavy uterine bleeding. This study will evaluate if patients would tolerate the same procedure in an office setting using local anesthetics and common pain medication. This study will include twenty patients.

Eligibility Criteria:
Inclusion Criteria:

* Heavy uterine bleeding

Exclusion Criteria:

* Uterine or cervical cancer
* Unable to tolerate office hysteroscopy
* Uterine fibroid tumors that distort endometrial cavity
* Uterine cavity greater than 12 cm
* Patients with hyperplasia or premalignant changes of the endometrium
* Active genital or urinary tract infections
* Intrauterine device
* Pregnant or want to become pregnant
Evaluation of a Pro-Active Dynamic Accommodating Socket

The primary objective of this study is to assess the effectiveness of the pro-active dynamic socket (PADS) on increasing socket comfort and fit for transfemoral and transtibial amputees during ambulation and rest, addressing residual limb volume fluctuations with a controlled flow bladder system.

The purpose of this study is to compare a pro-active dynamic socket to each user's everyday ischial containment socket in above-knee amputees, or transtibial socket in below-knee amputees. It is the goal for the pro-active dynamic socket to alleviate high pressure on the residual limb and improve socket fit and comfort. The pro-active dynamic socket contains bladders that can inflate and deflate throughout the gait cycle to appropriate levels of pressure to improve socket fit. These improvements will be confirmed by pressure measurements on the distal end of the residual limb, the ischium, and the bladders located around the socket walls.

Eligibility Criteria:
Inclusion Criteria:

* transfemoral or transtibial amputation
* unilateral or bilateral amputation
* stable residual limb volume
* read, write, and speak English for proper consent and responding to questionnaire

Exclusion Criteria:

* evidence or history of residual limb skin conditions such as irritation or sores
* presence of phantom limb pain
Efficacy of Administration of Somatostatin in the Prevention of Post-endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis

Acute pancreatitis is the most frequent (5-10%) and severe complication after endoscopic retrograde cholangiopancreatography (ERCP), that could require of surgical intervention and lead to death. A double- blind study designed to evaluate if the treatment with somatostatin in intravenous bolus before starting the ERCP procedure followed by a continuous infusion for 4 hours after endoscopic proof could prevent acute post-ERCP pancreatitis. Patients submitted to ERCP will be randomized in two groups of treatment, one will receive somatostatin and another placebo. The main aim of this study will be the incidence of acute post-ERCP pancreatitis and secondary objectives will be identify sub-groups of patient with high risk to develop post-ERCP pancreatitis, who could benefit of pharmacologic prophylaxis before the exploration. The study will include 510 patients submitted to an ERCP during a period of 3 years.

A double- blind study designed to evaluate if the treatment with somatostatin in intravenous bolus before starting the ERCP procedure followed by a continuous infusion for 4 hours after endoscopic proof could prevent acute post-ERCP pancreatitis. Patients submitted to ERCP will be randomized in two groups of treatment, one will receive somatostatin and another placebo. The main aim of this study will be the incidence of acute post-ERCP pancreatitis and secondary objectives will be identify sub-groups of patient with high risk to develop post-ERCP pancreatitis, who could benefit of pharmacologic prophylaxis before the exploration. The study will include 510 patients submitted to an ERCP during a period of 3 years.

Eligibility Criteria:
Inclusion criteria:

1. Patients undergoing therapeutic endoscopic retrograde cholangiopancreatography (ERCP).

Exclusion Criteria:

1. Pregnancy or history of allergy to somatostatin.
2. Acute myocardial infarction within 3 months of the procedure.
3. Acute pancreatitis in patients undergoing early ERCP in the acute phase of the disease.
4. Previous sphincterotomy.
5. Chronic pancreatitis.
Evaluation of Resynchronization Therapy for Heart Failure (EARTH)

Heart failure is a major health problem in Canada. Recent advances in medical and device therapy have helped to reduce the morbidity and mortality of patients with this problem. Among these treatments, cardiac resynchronization therapy (CRT) has very recently been shown to be effective to improve functional class, quality of life and exercise tolerance of the patients with the most severe symptoms of heart failure and a prolonged duration of the QRS on the 12-lead Electrocardiography (ECG).

Resynchronization of the failing ventricle is currently achieved by pacing the left and right ventricles simultaneously with specialized electrodes and a cardiac stimulator. However, controversy persists concerning the optimal configuration for cardiac pacing in these patients. Right ventricular pacing alone has been shown to be deleterious in some patient populations. The benefits of biventricular pacing in heart failure patients may be due primarily to left ventricular stimulation and may, in some patients, be decreased by the presence of simultaneous RV stimulation. Preliminary data from our own animal work suggest that in the majority of cases, LV stimulation alone is better than RV stimulation, and that BiV stimulation represents an intermediary situation between LV and RV stimulation.

Eligibility Criteria:
Inclusion Criteria (for Greater and Lesser EARTH):

Patient must answer "yes"

1. Does the patient require an ICD or an ICD replacement?
2. Does the patient have a documented LVEF less than or equal to 35% measured in the previous 6 months (without major concomitant clinical event)?
3. Does the patient have a QRS duration \< 120 ms?
4. Is the patient in sinus rhythm?
5. Was the six-minute walk test distance less than 400 meters and limited by heart failure symptoms?

Exclusion Criteria:

Patient must have answered "NO" to all of the exclusion criteria

1. Does the patient have:

   * Indication for permanent ventricular pacing?
   * Chronotropic insufficiency?
   * Second or third degree AV block, either persistent or intermittent?
   * A pacemaker or an ICD which is paced in ventricular chamber more than 5% of the time?
2. Does the patient have a reversible cause of LV dysfunction such as post-partum cardiomyopathy, tachycardia induced cardiomyopathy, acute myocarditis or acute toxic cardiomyopathy (including acute alcoholic)?
3. Did the patient have myocardial infarction or cardiac surgery in the 6 weeks preceding the pre-implant visit?
4. Does the patient have a moderate or severe cardiac valve stenosis?
5. Is the patient's capacity to walk is limited by reasons other than heart failure symptoms (e.g., angina, intermittent claudication, severe lung condition or arthritis)?
6. Does the patient have severe coexisting illnesses making survival \> 6 months unlikely?
7. Is the patient pregnant and/or nursing?
8. Is the patient unable or unwilling to consent or to comply with follow-up requirements?
9. Is the patient participating in another clinical study potentially interfering with the present trial?
10. Does the patient have a resynchronization system in place?
Impact of Diazepam 1% Oral Gel Efficacy in Burning Mouth Syndrome

Burning mouth syndrome (BMS) is a syndrome characterized by burning and persistent oral pain, ranging from mild to intense, in the absence of organic disorders of the oral cavity and with a major impact on the quality of life of the sufferer. Although several etiological theories have been proposed to explain BMS, none has been universally accepted to date, and its origin remains unclear. Currently, several scientific evidences would suggest that underlying BMS would be alterations in certain neuropathic mechanisms.

The purpose of the study is to evaluate the efficacy of Diazepam 1% oral gel in the treatment of burning mouth syndrome.

A double-blind placebo-controlled trial is conducted in order to evaluate the efficacy of Diazepam 1% oral gel and determine the statistical significance of the outcome variables. 40 patients with BMS, in two groups:

* case group with Diazepam 1% oral gel (Galenic formulation)
* control group with placebo in oral gel formulation

Follow-up of 2 months

Eligibility Criteria:
Inclusion Criteria:

* clinically diagnosed with BMS who reported a history of continuous oral burning pain for more than 4 months with no clinical signs that could justify the syndrome

Exclusion Criteria:

* • clinically diagnosed with BMS who reported a history of continuous oral burning pain for more than 4 months with clinical signs that could justify the syndrome
Closed-loop Insulin Delivery Systems in Pancreatic Diabetes

The purpose of this study is to evaluate the metabolic and the safety outcomes in people living with pancreatic diabetes (pancreatitis or pancreatectomy-induced diabetes) and using a closed-loop insulin delivery systems ("artificial pancreas").

Secondary pancreatic diabetes is an unstable diabetes, due to deficiency in B cells which produce insulin, alpha cells which produce glucagon, and exorcrine insufficiency. Patients with secondary pancreatic diabetes are exposed to high glycemic variability and severe hypoglycemic episodes. Hybrid closed loop treatment has shown efficacy and safety for patients with type 1 diabetes and has the potential to improve the control of secondary pancreatic diabetes but has rarely been studied in this particular indication.

A retrospective observational cohort study in patients will be contucted suffering from secondary pancreatic diabetes in whom this device was implemented in order to observe metabolic and safety outcomes compared to the period before they were treated with hybrid closed-loop system.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient
* Presenting secondary pancreatic diabetes
* Treatment with insulin closed-loop delivery

Exclusion Criteria:

* Patient who objected to the use of data
A Study of MIL62 in Patients With Neuromyelitis Optica Spectrum Disorder (NMOSD)

This study will evaluate the safety and efficacy of MIL62 in patients with Neuromyelitis Optica Spectrum Disorder.


Eligibility Criteria:
Inclusion Criteria:

1. Patient with NMOSD as defined by 2015 NMOSD diagnostic criteria by IPND (International Panel for NMO Diagnosis) with anti-AQP4-IgG seropositive status.
2. Male or female aged 18～60 years.
3. Expanded Disability Status Scale(EDSS) score ≤6.5.
4. A documented history of at least one attack requiring rescue therapy in the last year or two attacks requiring rescue therapy in the last 2 years prior to screening.
5. Subjects who have had a relapse immediately prior to screening must have at least 12 weeks in which their relapse symptoms are stable prior to the first administration.

Exclusion Criteria:

1. CD20+ B cell counts below the lower limit of normal (LLN). Receipt of rituximab or any B-cell depleting agent within the 6 months prior to screening, unless the subject has B-cell counts above the LLN. CD4 T lymphocyte count \<300 cells/μL(CD4：CD8≤1.4).
2. Receipt of tocilizumab, eculizumab within 3 months prior to the first administration.
3. Receipt of any of the following prior to the first administration: Azathioprine,Mycophenolate mofetil,Tacrolimus,Cyclosporin, Methotrexate,Cyclophosphamide,and Patients discontinued more than 5 times the half-life of the drug before they could get into the group .
4. Receipt of IVIG, plasmapheresis or blood transfusion within 28 days prior to the first administration.
5. Any live or attenuated vaccine within 28 days prior to the first administration.
NAtional TUnisian REgistry of Heart Failure

NATURE-HF is an observational, multicentric and longitudinal study of heart failure performed with 100 tunisian cardiologists.

The NATURE-HF is a national clinical non-interventional registry of heart failure, carried out in Tunisia at cardiology departments in hospitals and in liberal cardiology consultations. 100 cardiologists participate in the enrollment of the eligible patients as investigators. A Committee of Experts validates the protocol methodology and supervises the data-management. A Steering Committee helps investigators to monitor their patient inclusions, performs audit trails and prepares the statistical analysis plan for the study.

Collected data are managed by the DACIMA Clinical Suite®, the electronic data capture platform which complies with the FDA 21 CFR part 11 requirements (Food and Drug Administration 21 Code of Federal Regulations part 11), the HIPAA specifications (Health Insurance Portability and Accountability Act), and the ICH standards (International Conference on Harmonisation).

Eligibility Criteria:
Inclusion Criteria:

* Patient with chronic heart failure
* Patient with acute heart failure (new onset or not)
* The diagnosis of heart failure is at the discretion of the investigator
* Informed and signed consent

Exclusion Criteria:

* Life expectancy \<12 months for extra cardiac disease
* Isolated Right Heart Failure
* Pregnant woman
* Renal failure with creatinine clearance \< 15 ml / min
* Hemodialysis patients
* Cardiac surgery planned within 3 months
* Congenital heart disease
Assessment of Efficacy of the Consumption of a Heat-treated Lactobacillus Paracasei (GM080) on Atopic Dermatitis

The primary objective of this trial is to assess the efficacy of the consumption of heat-treated Lactobacillus paracasei (GM080) on atopic dermatitis as compared to a placebo treatment.


Eligibility Criteria:
Inclusion Criteria:

* Infants aged from 4-30 months (inclusive) at the time of enrolment (63 in each group).
* With mild to severe atopic symptoms: SCORAD ≥ 20 (at V0b).
* Having obtained his/her (or his/her legal representative's) written Informed Consent.

Exclusion Criteria:

* SCORAD inferior to 20 (SCORAD less than 20 at V0b). A SCORAD less than 20 at V0c is not an exclusion criteria.
* Infants who need a systemic treatment for their skin condition (e.g. glucocorticoids, steroids, cyclosporine A).
* Infants or mothers who introduce probiotics (other than the study product) in their diet during the 16-weeks intervention study. Of note: Infants or mothers who are used to consume a certain probiotic for more than 1 month before the start of the study (V0b), can continue to use this probiotic during the intervention period and will not be excluded. Recent introduction of probiotics, within a month before the planned start of the study (V0b) should be stopped and recorded; at least 1 month should be between stopping the consumption of the probiotic and V0b).
* Infants having other inflammatory skin diseases (urticaria, psoriasis).
* Infants having a congenital illness or malformation that may affect normal growth (especially immunodeficiency).
* Infants whose parents/caregivers cannot be expected to comply with the study procedures.
* Infants currently participating or having participated in another clinical study during the last 4 weeks prior to the beginning of this study.
* Infants using topical calcineurin inhibitors (e.g. tacrolimus and pimecrolimus (ELIDEL®)) during the study.
* Infants who have undergone in the month before the start of the study (V0b), are currently undergoing or are anticipated to undergo ultraviolet light therapy or wet dressing or any other topical treatment of their eczema other than the one provided in the study. Lotion and skin moisturizer are allowed but need to be monitored for frequency and area.
* The investigator and clinician will assess if the child has to be excluded based on the patient's medical condition and taken into account the values of the safety parameters tested. Therefore, no cut-off values, or normal ranges for the different safety parameters are exclusion criteria. It will be the responsibility of the investigator and clinician, based on their medical judgement, to decide if it is safe or not to include an infant into the study.
Probiotics for Eradication of Carbapenem Resistant Klebsiella Pneumonia

Infection by Klebsiella pneumonia producing class A carbapenemases is a major clinical and public health problem in Israel and worldwide. The aim of this study is to determine the safety and efficacy of alteration of the gut microflora by probiotics, alone or in combination with mechanical bowel cleansing, as a strategy to eradicate colonization of the gastrointestinal tract by CRKP. We hypothesize that administration of probiotics will decrease the rate of GI colonization by CRKP.

CRKP colonization will be determined by culture and PCR of rectal swabs. The study will include 3 arms - no intervention, probiotics and mechanical bowel cleansing + probiotics. Followup examination of rectal swab samples for the presence of CRKP will be performed at 4 weeks and 12 weeks from study entry.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects who are \> 18 years of age.
2. Signing of informed consent by subject or legal custodian.
3. Colonization of the gastrointestinal tract by CRKP as determined by stool culture or PCR of stool for the blakpc gene.
4. Negative cultures for CRKP from extra-intestinal sites excluding urine.

Exclusion Criteria:

1. Subjects who have participated in another clinical trial within the last three months.
2. Women with childbearing potential unless using adequate contraception (IUD, oral or depot contraceptive or barrier plus spermicide).
3. Subjects who are pregnant or breast feeding.
4. Subjects who will be unavailable for the duration of the trial, are likely to be non-compliant with the protocol, or who are felt to be unsuitable by the investigator for any other reason.
5. Subjects with chronic diarrhea (\>4 weeks).
6. Subjects with inflammatory bowel disease.
7. Subjects whose stool is positive for Clostridium difficile toxin.
8. Subjects receiving immunosuppressive treatment (i.e. corticosteroids; azathioprine or 6-MP; cyclosporine; tacrolimus; OKT3, methotrexate; anti TNF agents; chemotherapy).
9. Subjects who underwent solid organ or hematopoietic stem cell transplantation.
10. Subjects with primary or secondary immunodeficiency disorders, including HIV.
11. Subjects with chronic advanced cardiac, respiratory, renal or liver disease.
12. Subjects with advanced malignant disease.
13. Subjects with severe acute organ failure.
14. Subjects in whom CRKP is isolated from sites other than stool or urine (i.e. blood, sputum or wound cultures).
Impact of the Surgical Mask on the Patient-nurse Relation in Primary Care

The goal of this study is to inspect the effect of nurses wearing the surgical mask on their patients' satisfaction with the relationship. All participants will initially be treated without the mask. Then, half will be treated with the mask and the other half will be treated without the mask.

The use of the surgical mask has well-known benefits for both the patient and the professional regarding the control of infection contamination. However, its use is left to individual criteria, and is passed on from generation to generation of nurses through experiential, intuitive knowledge. Studies are necessary to support the use of the surgical mask.

Research indicates that wearing the mask affects perception of words, thus influencing patient-nurse communication. However, it might also affect the very nurse--patient relation. For example, it can convey the idea of personal distancing, which can either be appreciated by patients as dutiful professional care by the nurse, or viewed as a limit imposed on interpersonal communication and on the relationship.

This study inspects patient satisfaction about (1) interpersonal aspects and (2) professionalism in the patient-nurse relationship when the mask is used.

Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from chronic wounds
* Age: 18 years or older
* Know how to read and write in Portuguese
* Confirmed autopsychic and allopsychic orientation
* Maintain previous relation with the nurse of at least 18 months
* Need at least two consecutive treatments with the nurse

Exclusion Criteria:

* Failing to meet the above criteria
The Risk of Hypertension Associated With Oral Glucocorticoids in Chronic Inflammatory Diseases

Glucocorticoids are widely used for the treatment of chronic inflammatory diseases. In 2008, it was estimated that 0.8% of the United Kingdom adult population had used long-term (≥ 3 months) glucocorticoids, rising to 3% in women aged over 80 years.

The aim of the project is to investigate the dose-response estimates of risk of high blood pressure associated with oral glucocorticoids.

Hypertension is a chronic condition which affects 1 in 5 of the world adult population. The cause of hypertension is unknown in about 95% of patients, whilst 5% are secondary to underlying adrenal disorders or other identifiable causes.

Glucocorticoids are widely used for the treatment of chronic inflammatory diseases. In 2008, it was estimated that 0.8% of the UK adult population had used long-term (≥ 3 months) glucocorticoids, rising to 3% in women aged over 80 years. Glucocorticoids are effective in controlling underlying chronic inflammatory disease in majority of cases. However, their continuous use can result in a variety of complications, including hypertension.Although it is acknowledged that excess cortisol is a leading cause of hypertension, the role of exogenous glucocorticoids is less known.

The aim of the project is to investigate the dose-response estimates of risk of high blood pressure associated with oral glucocorticoids.

This is a retrospective cohort study of people diagnosed with at least one of six chronic inflammatory diseases (polymyalgia rheumatica, giant cell arteritis, systemic lupus erythematosus, rheumatoid arthritis, vasculitis and inflammatory bowel disease). This study will be based on the analysis of existing primary care health records routinely collected, linked to hospital and mortality data.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years old or over
* Registered in a participating general practice 1 year or more during the study period
* Minimum of 1 year prior to study entry meeting CPRD data quality
* Diagnosed with at least one of the 6 chronic inflammatory diseases

Exclusion Criteria:

* Patients aged under 18 years during the study period
* Registered in general practices that did not consent to data linkage