cyrilzakka/clinical-trials huggingface dataset:
Comparison Between Rituximab Treatment and General Corticotherapy Treatment in Patients With Pemphigus

Pemphigus is a severe and sometimes life-threatening disease with a mortality rate between 5 and 10 percent depending on the severity of disease and age of patients.

The standard of care is high doses of corticosteroids (CS) (usually, prednisone, 1 to 1.5. mg/kg/day, which are often associated with immunosuppressive drugs i.e., azathioprine, mycophenolate mofetil, cyclophosphamide, cyclosporine, although only one randomised study has demonstrated the superiority of the combination of corticosteroids and immunosuppressive drugs as compared to corticosteroids alone (9). Because of the low frequency of the disease, control trials are difficult to conduct. Evaluation of the different treatment regimens proposed, i;e; corticosteroids alone, CS and immunosuppressive drugs, IV immunoglobulins or new therapeutic regimens such as rituximab (an anti-CD20 monoclonal antibody directed against B- lymphocytes) or immunoadsorbtion.


Eligibility Criteria:
Inclusion Criteria:

* age \>=18 and \<= 80years
* consent obtained from patient
* effective female contraceptive method for women in procreate age
* new case of pemphigus vulgaris (PV) or pemphigus foliaceus (PF)

Exclusion Criteria:

* pemphigus vulgaris (PV) or pemphigus foliaceus (PF) treated
* pregnant woman or nursing mother
* woman able to have a baby and without contraception during the clinical trial period
* age \< 18 or \> 80
* karnovsky \< 50%
* serious antecedents of allergy or anaphylactic reaction with human monoclonal antibody
* patient with depletion lymphocytic treatment in the next month
* unstable angina or ischemic heart disease
* cardiac insufficiency
* cardiac rhythm trouble uncontrolled
* positive HIV serology
* positive hepatitis B and / or C serology
* no consent
Virtual Reality Hypnosis Versus Inhaled Nitrous Oxide in Anterior Shoulder Dislocation Reduction: an Open Multicenter Randomized Controlled Trial

Anterior shoulder dislocation (ASD) is a common situation in the emergency department (ED). Quick reductions lead to reduced mid and long term complications. No technique is superior to one another. Inhaled nitrous oxide can deal with pain reduction and anxiety but its efficacy is not optimal, with safety issues. Virtual reality hypnosis (VRH), by distracting patients from their pain, may lead to a better muscular relaxation and an easier ASD reduction.

Our first objective is to evaluate the clinical interest of VHR compared to nitrous oxide, in ASD reduction. Our second objective is to evaluate the safety of VRH in ASD reduction.

Patients over 18 years presenting an ASD \< 24 hours, will be illegible for enrollment in an open multicenter randomized controlled trial, conducted in the Great East Region in France.


Eligibility Criteria:
Inclusion Criteria:

* patients of 18 years and older
* consulting the ED for a ASD \< 24 hours
* with or without history of ASD
* with social insurance

Exclusion Criteria:

* non anterior shoulder dislocation
* shoulder or facial fracture or multiple trauma patient
* dementia, psychosis
* uncontrolled epilepsy
* visual or hearing issues
* claustrophobia
* vascular or nervous lesion of the dislocated arm
* contraindication with the use of inhaled nitrous oxide
The Effect of Progressive Relaxation Exercises on Fatigue and Sleep Quality in İndividuals With Epilepsy

Aim: It was conducted to determine the effect of web-based animation supported progressive relaxation exercise on fatigue and sleep quality in individuals with epilepsy. Material and Methods: As a randomized controlled study with a pretest- posttest model, it was conducted with individuals with epilepsy who applied to Giresun University Faculty of Medicine Neurology Outpatient Clinic between February and December 2022.The sample of the study was determined as 60 epilepsy patients, 30 of which were in the control-30 experimental group, using power analysis. The data were collected by face-to-face interview technique using Personal Information Form, Pittsburg Sleep Quality Index, Fatigue Severity Scale.


Eligibility Criteria:
Inclusion Criteria:

* be over the age of 18
* Having been diagnosed with epilepsy for at least 6 months
* Individuals with an average score of 4.1 or higher on the fatigue severity scale
* Individuals with a Pittsburg Sleep Quality Index total score above 5
* Being able to use mobile phone (IOS-Android)
* Being able to speak Turkish
* Up to 6 months before the study, techniques such as meditation, hypnosis, yoga not benefited,
* Having a neurological, systemic and psychiatric disease other than epilepsy not to be.

Exclusion Criteria:

* Not using a mobile phone,
* Up to 6 months before the study, techniques such as meditation, hypnosis, yoga to have benefited,
* Having a neurological, systemic and psychiatric disease other than epilepsy be.
Cranial Osteopathy in Infantile Colic

Background Excessive Crying (Infantile Colic) is one of the most common complaints for which parents seek treatment. These otherwise healthy and well fed infants show no signs of failure to thrive, cry without identifiable cause, fuss a lot and are hard-to-soothe.

Objective To explore the feasibility of running a Randomised Controlled Trial (RCT) that investigates the effectiveness of cranial osteopathy in addition to usual National Health Service (NHS) care in infants with colic.

Methods Pragmatic randomised controlled trial, involving United Kingdom (UK) osteopaths in private practice and NHS health visitors. Parents of 60 excessively crying infants/infants with colic will be recruited by NHS health visitors. Infants will be included into the study if they are healthy (full-term) and aged 1-7 weeks, diagnosed with excessive crying/infantile colic, and have no co-morbidities. Participants will be randomised into the usual NHS care group or the usual NHS care plus cranial osteopathic intervention group.

Usual NHS care will be provided by health visitors and osteopathic treatment will be carried out by experienced osteopaths in private practice.

Primary outcome measures are acceptability and feasibility of intervention procedures. Furthermore, changes in the frequency and duration of crying will be documented in a daily crying diary. Parental quality of life will also be assessed.

This pilot investigation will provide useful information in order to further develop and adapt the current interventions and trial procedures with a view to a full-scale randomised controlled trial.


Eligibility Criteria:
Inclusion Criteria:

* healthy, diagnosed with excessive crying by NHS Health Visitors No comorbidities Parents are able to adequately communicate in English

Exclusion Criteria:

* Currently participating in other therapeutic clinical trials Currently receive manual therapy treatment
A Randomized Study of Intraocular Caliper-assisted Capsulotomy for Age-related Cataract Patients With Corneal Limbus Opacity

The purpose of this study is to compare the accuracy of capsulotomy assisted by intraocular caliper and Verion navigation system in phacoemulsification surgery and postoperative visual quality for age-related cataract patients with corneal limbus opacity.

Continuous curvilinear capsulorhexis (CCC) is an important and technically challenging procedure in cataract surgery. Too large or too small capsulorhexis can increase the incidence of intraoperative and postoperative complications.

In recent years, the image projection device Verion navigation system has been reported that it can improve the repeatability and accuracy of capsulorhexis via projecting a pre-set size ring to guide capsulorhexis. However, we found that for the patients with corneal geriatric ring, pterygium or limbal lesions leading to unclear limbal boundary, the projected capsulorhexis will deviate from the center, resulting in capsulorhexis is off center in clinical practice. Our self-developed intraocular caliper, which is modified on the conventional intraocular irrigation needle, can accurately measure the size of capsulorhexis, and mark the position and boundary of capsulorhexis on the lens anterior capsule to guide capsulorhexis, thus significantly improves the accuracy and centricity of capsulorhexis.

The purpose of this study is to compare the centricity and accuracy of intraocular caliper-assisted capsulorhexis in phacoemulsification for age-related cataract patients with corneal limbus opacity with that of Verion projection navigation system.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 55 to 80 years with age-related cataract with pterygium, Corneal geriatric ring, and corneal limbus opacity;
* Pupil diameter ≥ 6.5mm after pupil dilation;
* Lens nuclear opacity grading score (LOCS III) lower than 4.0.

Exclusion Criteria:

* Patients had previous intraocular surgery;
* Patients with a diagnosed eye disease that may affect the functions of lens suspensory ligament such as previous ocular trauma, lens subluxation, pseudoexfoliation syndrome, retinal pigment degeneration;
* Patients had other ocular diseases that impair visual function include optic neuropathy, uveitis, and tumor.
* Refused to participate the study.
Intraoperative Lidocaine Infusion and Surgery-induced Release of Pro-inflammatory Cytokines After Abdominal Surgery

Lidocaine is an amide local anaesthetic and an antiarrhythmic agent, first synthesized in 1942, and after approval for human use was launched in 1948 in Sweden The first observations of post operative analgesic effects of perioperative intravenous lidocaine (IVL) were initially proposed in 1951 subsequently many more enthusiastic reports followed. Postoperative formal clinical evaluations in the perioperative setting were conducted in the late 1950s where IV Lidocaine was demonstrated to have a postoperative analgesic effect without posing the risk of respiratory depression, reducing the occurrence of postoperative nausea and vomiting (PONV), and enhance post-surgical recovery. IV Lidocaine also potentiated the depth of anesthesia and led to a better tolerance of endotracheal intubation.Around 40% of patients experience a delay in resumption of normal bowel function after colorectal surgery. This delay leads to symptoms of nausea, vomiting, constipation, and abdominal distension, which then require unpleasant supportive interventions such as intravenous fluids and nasogastric tube insertion. There is no remedy to address this delay. ALLEGRO, "A placebo-controlled randomized trial of intravenous Lidocainein accelerating Gastrointestinal Recovery surgery," is the latest ongoing multicenter research study across the United Kingdom, investigating the use of intravenous lidocaine to improve recovery after colorectal surgery


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and older.
* Both sexes, males and females
* Patients scheduled for elective intestinal surgery.
* Body mass index (BMI) 18-30 kg•m-2.
* ASA I - II.

Exclusion Criteria:

* Patient refusal
* Patients with preoperative gastrointestinal dysfunction.
* Patients with a history of drug abuse, or long-term opioid use.
* ASA III and VI
* Patients with a history of previous gastrointestinal surgery
Angiotensin II Pathway and Postoperative Hypoxemia

Acute type A aortic dissection is often accompanied by postoperative hypoxemia, the cause of which is not fully understood. Angiotensin II is an important component of the renin-angiotensin system (RAS), which has been suggested to be involved in the development of aortic dissection and pulmonary inflammation.The purpose of this study was to investigate the role and mechanism of angiotensin II pathway in postoperative hypoxemia after acute type A aortic dissection, and to provide reference for clinical application


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing surgery for acute type A aortic dissection
* age between 18 to 80

Exclusion Criteria:

* perioperative severe cardiac insufficiency
* rejection of consent
The Effect of CORT118335 on Olanzapine-Induced Weight Gain

This study will investigate if there is any difference in the amount of weight gained by participants taking olanzapine with CORT118335 compared with olanzapine with placebo (a dummy test medicine which looks like CORT118335 but contains no active medicine). Safety and tolerability of CORT118335 when taken with olanzapine will also be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index 18.0 to 25.0 kg/m\^2, inclusive
* Stable body weight as indicated by assessment at screening and pre-dose
* Able to swallow the size and number of tablets required
* Provide written informed consent and agree to adhere to study restrictions and contraception requirements.

Exclusion Criteria:

* Have received any investigational medicine in a clinical research study within the previous 3 months, or CORT118335 at any time
* Employee, or immediate family member of a study site or Sponsor employee
* Have a pregnant partner
* History of abuse of any drug or alcohol, or regularly consume more than 21 units alcohol/week
* Smokers or users of e-cigarettes and nicotine replacement products within the last 6 months
* Clinically significant abnormal results of clinical laboratory safety tests, electrocardiogram, or measurement of heart rate and blood pressure
* History of clinically significant cardiovascular, renal, hepatic, endocrine, metabolic, respiratory, or gastrointestinal disease, neurological or psychiatric disorder
* History of jaundice or gallstones or had a cholecystectomy
* Family history or known risk for narrow angle glaucoma
* Consumed liquorice or other glycyrrhetic acid derivatives regularly in the past 6 months
* Any condition that could be aggravated by glucocorticoid and/or mineralocorticoid antagonism (e.g., asthma, any chronic inflammatory condition, postural hypotension/orthostatic symptoms)
* Presence or history of clinically significant allergy
* Donation or loss of greater than 400 mL of blood within the previous 3 months
* Are taking, or have taken, any prescribed or over-the-counter drug within 14 days other than paracetamol or standard dose multivitamins. Longer restrictions apply for some medicines.
* Lactose intolerance.

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Chronic Pain and Transcranial Direct Current Stimulation in Clinical Settings

Physical exercises and transcranial direct current stimulation (tDCS) are both known to reduce chronic pain in structured laboratory studies. The aim of this study is to assess the efficacy of this combined treatment in clinical settings.

Chronic pain patients who are going to the physiotherapy clinic to receive tDCS treatment sessions are evaluated in order to assess the efficacy of tDCS in clinical settings. Physiotherapists prescribe physical exercises adapted to the patients conditions. Patients performed their physical exercises every time they received a tDCS treatment, but were also recommended to continue their physical exercises program at home after completion of physiotherapy visits.

Concerning tDCS treatment, patients were encouraged to receive 1 tDCS session per day for 5 consecutive days.

Eligibility Criteria:
Inclusion Criteria:

* To have chronic pain

Exclusion Criteria:

* Contraindication to tDCS
A Trial of Multiple-doses of Aripiprazole in Adults With Schizophrenia or Bipolar 1 Disorder

The purpose of this trial is to determine the safety and tolerability of multiple-dose administrations of aripiprazole, to establish the similarity of aripiprazole concentrations on the last day of the dosing interval following the final administration of aripiprazole into the gluteal muscle site, and to establish the similarity of aripiprazole exposure over the dosing interval following the administration of aripiprazole into the gluteal muscle site in adult participants with schizophrenia or bipolar I disorder.


Eligibility Criteria:
Inclusion Criteria:

* A current diagnosis of schizophrenia or bipolar I disorder, as defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria.
* Body mass index of 18 to 35 kilograms per meter square (kg/m\^2).
* On a stable dose of an atypical oral antipsychotic medication for at least 2 months prior to screening.

Exclusion Criteria:

* Participants who have:

  * Met DSM-5 criteria for substance use disorder within the past 180 days.
  * A positive drug screen for drugs of abuse
* Use of any psychotropic medications other than their current non-aripiprazole antipsychotic or mood stabilizer(s) medication; or participants who use more than one antipsychotic or mood stabilizer(s) medication at screening.
* Females who are pregnant, breast-feeding, lactating, and/or have a positive pregnancy test result prior to receiving investigational medicinal product (IMP). A negative serum pregnancy test must be confirmed prior to the first dose of IMP for all female participants.
* Any major surgery within 30 days prior to enrollment or scheduled/elective surgery during the trial.
* Evidence of organ dysfunction or any clinically significant deviation from normal in the physical, electrocardiographic, or clinical laboratory examinations.
* Participants currently in an acute relapse of schizophrenia.
* Participants with a current DSM-5 diagnosis other than schizophrenia or bipolar I disorder, including schizoaffective disorder, major depressive disorder, delirium, dementia, amnestic, or other cognitive disorders. Also, participants with borderline, paranoid, histrionic, or antisocial personality disorder.
* Participants with a history of neuroleptic malignant syndrome or clinically significant tardive dyskinesia.
* History of any significant drug allergy or known or suspected hypersensitivity, in particular to aripiprazole or other quinolinones.
* History of or current hepatitis or acquired immunodeficiency syndrome or carriers of Hepatitis B surface antigen (HBsAg) or Hepatitis C antibodies (anti-HCV), and/or Human immunodeficiency virus (HIV) antibodies.
* Participants deemed intolerant of receiving injections.
* Participants who have had electroconvulsive therapy within 2 months of administration of IMP.
Observational Retrospective Study on Treatment and Outcomes in Patients With Low-grade Serous Ovarian Cancer

The purpose of this study is to retrospectively evaluate treatments and outcomes of patients with low grade serous ovarian carcinomas in Italy.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis low-grade serous ovarian carcinoma
* OR invasive recurrence after surgical resection of borderline serous ovarian carcinoma
* Availability of archival tumor specimen (paraffin embedded block) for central analysis and evaluation for mutations
* Age \> 18 years
* Signed informed consent

Exclusion Criteria:

* High-grade serous, mucinous, endometrioid, or any other non-low-grade serous ovarian carcinoma
* Unavailability of archival tumor specimen
ESP/PIF for Sternotomy

This is a randomized study. The purpose of this study is to evaluate the effect of post-surgical pain control of two types of peripheral nerve blocks, specifically erector spinal plane (ESP) block and pecto-intercostal fascial (PIF) plane block.

90 subjects, from 18-85 years of age, undergoing cardiac surgery with median sternal incision will be enrolled at Mount Sinai Morningside Hospital Center. Study participation will last from the time of pre-operative evaluation to 72 hours after surgery. Subjects will be randomly assigned to receive 1 of the 3 different regimens at the beginning of surgery. Opioid consumption and pain scores after surgery will be evaluated. Though unlikely, risks include systemic absorption of local anesthetic, which can result in both central nervous system and cardiac toxicity.


Eligibility Criteria:
Inclusion Criteria:

* Adults 18-85 years old
* Scheduled to undergo cardiac procedures involving sternotomy
* All genders

Exclusion Criteria:

* ASA class V
* Urgent or emergent surgery
* Contraindications to administration of local anesthesia (e.g. local anesthetic allergy)
* History of substance abuse or chronic opioid use
* Patient refusal or inability to consent
Occipital Transcranial Direct Current Stimulation in Fibromyalgia

The aim of this study is to investigate whether transcranial direct current stimulation is effective in the treatment of fibromyalgia related pain. The study provides a placebo arm and the design is a cross-over design.


Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from Fibromyalgia, diagnosed according to the criteria of the ACR-90, with exclusion of other pathologies mimicking the FMS related symptoms by a M.D. of the department of Physical Medicine and Rehabilitation (UZA, Belgium)
* Dutch speaking
* Stability of medication during the study

Exclusion Criteria:

* History of substance abuse, unless treated and in remission during 6 months
* Cardiac disease, implanted pace-maker or defibrillator
* History of epileptic insults
* Severe organic comorbidity
* Psychiatric comorbidity with psychotic symptoms
* Pregnancy
Evaluation of Fontan-Associated Liver Disease

A study to evaluate the efficacy of MZ101 therapy in reducing liver stiffness.

This is open-label, long-term prospective study in a cohort of Fontan subjects taking drug daily for one year. The study will determine the scope of hepatic stiffness in the cohort by ultrasound and magnetic resonance imaging elastography and evaluate MZ101 pharmacotherapy as a potentially efficacious treatment to reduce liver stiffness.

Eligibility Criteria:
Inclusion Criteria:

1. Enrollment in on-going Phase 3 Open-Label Safety Study
2. Informed assent from subject, informed consent from parent/legal guardian as appropriate

Exclusion Criteria:

1. Non-enrollment in the on-going Phase 3 Open-Label Study
2. Subjects with contra-indications for MRI (these subjects will be excluded from the MRI component of this study)
3. Other exclusionary criteria will match those used for the Open-Label Safety Study