cyrilzakka/clinical-trials huggingface dataset:
Comparison Between Fully Covered Metal Stents and Plastic Stents in Preoperative Biliary Drainage

This study is a prospective, randomized study to compare of outcome of fully covered metal stents with that of plastic stents for preoperative biliary drainage in distal common bile duct cancer, pancreas head cancer or ampullary cancer with respect to the incidence of stent-related adverse events, the re-intervention rate, the effectiveness of biliary drainage, surgical outcomes and hospital stays.

Pancreaticoduodenectomy is curative option in periampullary tumor. Preoperative endoscopic retrograde cholangiopancreatog-raphy (ERCP) is usually undertaken in patients with resectable disease to relieve biliary obstruction, which is thought to impair immune response, clotting, and other functions that impact intraoperative and postoperative outcomes. Despite conflicting data pertaining to preoperative biliary drainage, ERCP with biliary stenting has become standard practice in patients with periampullary malignancies. In a recent multicenter randomized trial, patients who underwent preoperative biliary drainage had a 74% rate of complications compared with 39% for those who directly underwent surgery without preoperative biliary drainage. In this trial, however, all patients underwent placement of plastic stents. In ERCP, self-expandable metal stent are being increasingly placed for palliation of malignant biliary obstruction. Compared with plastic stents, self-expandable metal stents have large caliber and have demonstrated longer patency duration. Even in patients with resectable malignant disease, self-expandable metal stents which are placed below the level of transection may not impair technical outcomes at surgery and can be safely removed along with the surgical specimen.

This prospective study is designed to compare the incidence of stent-related adverse events, the re-intervention rate, the effectiveness of biliary drainage, surgical outcomes and hospital stays in patients with periamupllary tumors who are undergone with self-expandable metal stents or plastic stents placement for preoperative biliary drainage

Eligibility Criteria:
Inclusion Criteria:

* Older than 20 years old of age
* Obstructive jaundice due to common bile duct cancer and pancreas head cancer, or ampullary cancer
* No evidence of distant metastases or locally advanced tumor

Exclusion Criteria:

* Unresectable stage of cancer
* Preoperative gastric operation that preclude ERCP (total gastrectomy and subtotal gastrectomy with B-II anastomosis)
* Severe gastric outlet obstruction or duodenal obstruction
* Severe comorbidity (Karnofsky\<50%)
Neuroprotective Effect of Remote Ischemic Conditioning in Ischemic Stroke Treated With Mechanical Thrombectomy

The benefit of mechanical thrombectomy in the treatment of ischemic stroke has been demonstrated in several multicenter randomized trials. However, it leads to a sudden reperfusion of the brain parenchyma associated to an extension of the infarct volume. Evidence has indicated that remote ischemic conditioning (RIC) reduces final infarct size in animal stroke models. The main objective of the present study is to determine whether remote ischemic conditioning can limit the final infarct volume after recanalization of the occluded cerebral artery.


Eligibility Criteria:
Inclusion Criteria:

* Age at least 18 years old,
* Carotid ischemic stroke related to a full occlusion of the middle cerebral artery (occlusion of middle 1 (M1) and/or proximal middle 2 (M2) identified as candidate for endovascular intervention according to local criteria,
* Brain Magnetic Resonance Imaging (MRI) performed within 6 hours from symptoms onset,
* Acute stroke MRI including at least diffusion weighted imaging (DWI), fluid attenuated inversion recovery (FLAIR), intracranial vessel imaging with Magnetic Resonance Angiography (MRA) and perfusion weighted imaging (PWI),
* Modified Rankin Score (mRS) score less than or equal to 1 before ischemic stroke,
* Obtaining a written informed consent of the patient or a next of kin, or emergency inclusion process.

Non inclusion Criteria:

* Previous ischemic stroke or transient ischemic attack (TIA) in the previous 3 months,
* Contraindications to iodinated contrast agents,
* Sickle cell disease known (risk of vaso-occlusive crisis),
* Life expectancy less than 90 days,
* Pregnant or women of childbearing age who were not using contraception (oral diagnosis),
* Patient without health coverage,
* Patient under legal protection.
* Any contraindication to Magnetic Resonance Imaging (MRI) (example cardiac pacemaker),
* Intracranial bleeding,
* Intracranial expansive process.

Exclusion Criteria:

* Recanalization of M1 or proximal M2 segment at the time of thrombectomy
Misoprostol for Preventing Postpartum Hemorrhage

This hospital-based, multicenter, randomized, placebo-controlled trial will assess the effects of misoprostol as part of active management of the third stage of labor on postpartum blood loss, complications, and side effects. Twelve hundred eligible women will receive routine oxytocics (oxytocin 5-10 IU) plus either 400 mcg sublingual misoprostol or placebo during or immediately after delivery. The primary outcome will be measured blood loss of =\>500 mls within one hour after enrollment.


Eligibility Criteria:
Inclusion Criteria:

* Women who have given birth to 1 or more live-born infants (para 1 or more)
* Vaginal delivery

Exclusion Criteria:

* Refusal or inability to give informed consent
* Delivery regarded as abortion according to local gestational age limits
* Inability to take misoprostol sublingually
* Cesarean section
* Assisted vaginal delivery
High Intensity Interval Training Versus Intermittent Fasting on Functional Capacity Among Overweight Subjects

The purpose of the study is to compare the effect of high-intensity interval training and intermittent fasting on improving body weight and functional capacity among overweight subjects.

Exercise improves cardiorespiratory fitness, muscle strength, endurance, body composition, and decreases visceral fat. The, increase in physical activity and modification of eating behaviors are the first line of interventions given because of their low costs and low risks of complications.

Most commonly, the continuous exercise of moderate intensity, that has to be performed several days of the week to get target benefits have been used, on the other hand, different forms of training which aim to reduce time spent exercising by increasing exercise intensity have been considered as an alternative to increasing adherence to the training program which is supported by some researches that may have greater benefits as high intensity interval training improves the vascular function of the muscle capillary density and endothelial nitric oxide synthase(eNOS) levels. But there are some overweight people even some of the young people have restriction to perform exercise programs due to any medical problem that could interfere with exercise.

So, searching for optimal dietary interventions for obesity is still ongoing, but the modification in eating behaviors are hampered by difficulties in coping with a different diet. So, the diet with a fasting component that will be used in this study may be more effective than other complex and restrictive diets as it essentially limits the caloric intake to a specified period without major diet composition changes.

So, the aim of this study is to compare the effect of high-intensity interval training and intermittent fasting on improving body weight and functional capacity among overweight subjects.

Eligibility Criteria:
Inclusion Criteria:

* Subjects have to meet all the following criteria in order to participate in the study:

  1. Overweight subjects with age from 25 to 35 years.
  2. Body mass index will be range from 25 to 29.9 kg/m2.
  3. Waist circumference ≥ 80 cm2.
  4. A minimum of 70% of exercise program and diet regimen compliance will be required in order to be included.

Exclusion Criteria:

* Subjects with the following disorders will be excluded from participating in this study:

  1. Musculoskeletal, cardiovascular disorders.
  2. Asthma, chronic obstructive pulmonary diseases.
  3. Any systemic disease or condition that might reduce adherence or tolerance to exercise or fasting.
  4. History of stroke.
Comparison of an Artificial Intelligence-Assisted Rehabilitation Program for Shoulder Musculoskeletal Disorders and the Clinical Decision Making of Therapists

People with shoulder musculoskeletal disorders among middle-aged and older adults have the highest need of rehabilitation services. The population growth and aging society subsequently increase the number of disabled people, the healthcare costs and the needs for healthcare professionals. The evidence exists to support the beneficial effect of exercises on function and quality of life. Traditionally, a rehabilitation program is designed by therapists for each patient depending on their conditions. In recent years, AI is increasingly being employed in the field of physical and rehabilitation medicine, however, there is no study of applying AI in predicting rehabilitation programs for shoulder musculoskeletal disorders. The main purpose of this study is to explore the possibilities of using supervised machine learning approach to predict rehabilitation programs for shoulder musculoskeletal disorders. Twenty-three features are identified based on shoulder range of motion, pain, whether or not perform surgical procedure. Each exercise is considered as a label with a total of twenty-five exercises. Dataset is collected by clinical therapists to develop and train the model. Each patient has to receive at least two months of rehabilitation and two times of evaluation. Logistic regression, support vector machine and random forest are used to build the computational model. Accuracy, precision, recall, F-1 score and AUC are used to evaluate the performance of the computational model in machine learning. After training, we compare the consistency of rehabilitation programs predicted by using machine learning model and the clinical decision making of therapists.


Eligibility Criteria:
Inclusion Criteria:

1. The International Classification of Diseases, 10th revision (ICD-10) codes were selected before the study started and included the ICD-10 codes M75 (Shoulder lesions), S42 (Fracture of shoulder and upper arm), S43 (Dislocation and sprain of joints and ligaments of shoulder girdle), and S46 (Injury of muscle, fascia and tendon at shoulder and upper arm level)
2. Patients who need rehabilitation after undergoing surgical procedure and are able to perform stretch, active assistive range of motion (AAROM) or supervised active range of motion (AROM)
3. between 20-80 years old
4. Are able to follow motor commands

Exclusion Criteria:

1. Patients with central and peripheral nervous system disease, such as cerebrovascular accident (CVA), Parkinson's disease (PD), myasthenia gravis (MG), poliomyelitis
2. Patients who had shoulder contusion, vascular injury, severe crush injury and amputation
Efficacy and Safety of Non Invasive Vagal Stimulation to Prevent Chemotherapy-induced Nausea

Despite pharmaceutical innovations, chemotherapy induced nausea is frequent and largely participating to alter our patients quality of life.

Non invasive vagal stimulation is approved in other health issues, for example in headache or gastroparesis, with a reported benefit on nausea.

This study aims to analyse if a non invasive vagal stimulation could better prevent chemotherapy induced nausea, in addition to standard treatment, in breast cancer patients treated with cyclophosphamide and anthracycline.

Despite pharmaceutical innovations, chemotherapy induced nausea is frequent and largely participating to alter our patients quality of life.

Non invasive vagal stimulation is approved in other health issues, for example in headache or gastroparesis, with a reported benefit on nausea.

This study aims to analyse if a non invasive vagal stimulation could better prevent chemotherapy induced nausea, in addition to standard treatment, in breast cancer patients treated with cyclophosphamide and anthracycline.

Eligibility Criteria:
Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) status 0 to 2
* patient with breast cancer planned to receive Anthracycline and Cyclophosphamide chemotherapy
* informed consent
* compliance expected
* social security affiliation

Exclusion Criteria:

* nausea or vomiting 24h or less, before inclusion
* Antiemetic drug intake in the last 72h before inclusion
* Central nervous system metastasis
* Daily alcohol intake
* Prior chemotherapy
* Cardiac arrythmia, severe heart failure
* Device for sleep apnea
* History of arterial or venous thrombosis, or thrombophlebitis
* Vagotomy
* Vagal stimulation ongoing
* Skin disease on the stimulation zone
* Cochlear implant next to the stimulation zone
* Unable to use the vagal stimulation device due to left ear unusual shape
* Pregnant or breastfeeding women, or women of childbearing age without effective contraception
* Documented allergy or contraindication to one of the antiemesis drugs required in the study
* Protected adults (individuals under guardianship by court order)
* Unable to read or write
Efficacy of Autologous Outer-Root-Sheath Melanocytes Transplantation in the Treatment of Vitiligo

The purpose of this study is to evaluate the hypothesis that, in patients with stable vitiligo unresponsive to conventional treatments including traditional phototherapy and/or topical steroids, the application of a non-cultured autologous hair follicle outer-root-sheath melanocytes suspension in the area affected by the disease followed by targeted ultraviolet B (UVB) phototherapy can lead to a significant skin repigmentation. To assess the effect of the proposed treatment, a within-subject controlled study involving selected symmetric lesion areas localized to the back of the hands will be conducted.


Eligibility Criteria:
Inclusion Criteria:

* Presence of symmetric lesions of vitiligo at the back of the hands with an extension \>5cm²
* Vitiligo lasting at least one year at the backs of both hands
* Stable vitiligo, defined as vitiligo that presents no evident evolution (appearance of new lesions or increase in the extension of lesions already present) for at least 6 months
* Suspension for at least two months prior to the enrollment date of any systemic drug for vitiligo such as immunosuppressive treatment (cyclosporine, systemic steroids) or psoralen + ultraviolet A therapy, phototherapy with ultraviolet B, and of any anticoagulant drug
* Suspension of topical medications for at least 15 days prior to the enrollment date

Exclusion Criteria:

* Presence of active vitiligo or Koebner phenomenon
* Difference of more than 10% in the extension of symmetrical areas of vitiligo
* Presence of systemic infections or infections localized to the tissues intended for transplantation
* History of infections to the tissues intended for transplantation (herpes simplex, human papillomavirus infections, pityriasis versicolor, pityriasis alba)
* Presence or history of malignancy
* Chemotherapy or radiation therapy in progress
* History of allergies or adverse reactions to local anesthetics
* Presence of transmissible diseases (human immunodeficiency virus, hepatitis B and C, human T-lymphotropic virus type I and II, syphilis, cytomegalovirus, Creutzfeldt-Jacob, tuberculosis)
* Women who are pregnant or intend to become pregnant during the study period (including breastfeeding women)
Treatment of Acute Rhino-Sinusitis With Essential Oils of Aromatic Plants

This randomized, double blind, parallel group study, compared the efficacy of spray containing aromatic essential oils of some herbal plants, against placebo in the treatment of patients with acute Rhino-sinusitis.

Study objectives: Primary to demonstrate a relief in the nasal obstruction within 20 minutes after first administration of treatment with the spray.

Secondary to demonstrate a reduction of a defined symptoms sum score based on symptoms and signs comparing baseline therapy from the beginning to the end of 3 days treatment

This study compared the efficacy of spray containing aromatic essential oils of Eucalyptus citriodora, Eucalyptus globulus, Mentha piperita, Origanum syriacum, and Rosmarinus Officinalis, against placebo in the treatment of patients with acute Rhino-sinusitis.

In- vitro and clinical studies suggest therapeutic potential of aromatic herbs and trees oils in the treatment of Rhino-sinusitis. The pharmacological and clinical activity of Eucalyptus citriodora, Eucalyptus globulus, Mentha piperita, Origanum syriacum, and Rosmarinus Officinalis, include anti-inflammatory, anti-bacterial and anti-viral activities. Some of these herbs and trees oils have direct activity on the respiratory tract, the coughing reflex and the airflow in the nasal tract.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of acute Rhino-sinusitis.
* Active disease less than 96 hours
* Patients agree to sign informed consent according to GCP and Israel national regulations.

Exclusion Criteria:

* Acute Sinusitis that need to get an antibiotically treatment .
* Nasal polyposis.
* Under any antibiotically treatment.
* Asthma disease.
* Under coumadine therapy.
* Hyper sensitivity to Aromatic essential oils.
* Any immuno-suppressive disease
Study of an Anti-OX40 Monoclonal Antibody (KHK4083) in Subjects With Moderate to Severe Atopic Dermatitis

A Phase 2, multicenter, randomized, placebo-controlled, double-blind, parallel-group study for subjects with moderate to severe AD whose disease cannot be adequately controlled with topical medications or for whom topical treatment is medically inadvisable.


Eligibility Criteria:
Inclusion Criteria:

* Voluntarily signed informed consent to participate in the study;
* Chronic AD, according to American Academy of Dermatology Consensus Criteria or the local diagnostic criteria, that has been present for at least 1 year before screening;
* EASI score ≥16 at screening and baseline;
* IGA score ≥3 (moderate) at both screening and baseline;
* BSA ≥10% at both screening and baseline;
* Documented recent history (within 1 year prior to screening visit) of inadequate response to treatment with topical medications or for whom topical treatments are otherwise medically inadvisable (e.g., because of important side effects or safety risks).

Exclusion Criteria:

* Current or past history of clinically significant illness(es) deemed by the Investigator to be likely to affect the study conduct and assessments. Examples include, but are not limited to, clinically significant cardiovascular (e.g., New York Heart Association \[NYHA\] Class III or IV), uncontrolled diabetes (HbA1c ≥9%), liver (e.g., Child-Pugh class B or C), renal, respiratory, hematologic, central nervous system, psychiatric, or autoimmune diseases/disorders;
* Any of the following laboratory abnormalities at screening:

  * Serum creatinine: \>1.5 mg/dL
  * AST or ALT: ≥2.5 times the upper limit of normal (ULN)
  * Neutrophil count: \<1.5×10³/μL
  * Other laboratory abnormalities that may affect the completion or evaluation of the study, as judged by the Investigator;
* Active malignancies, or onset or a history of treatment of malignancies within 5 years prior to informed consent (except curatively treated in situ cervical carcinoma, cutaneous basal cell carcinoma, or cutaneous squamous cell carcinoma).
Cognitive Behavioral Aggression Treatment

Aggressive behavior is a leading worldwide public health problem. Despite this, relatively little is known about how to best treat individuals who are highly angry and aggressive. A rich literature suggests that aggression is associated with a tendency to interpret situations as threatening or hostile even when they are not. This process is governed by a prefrontal-limbic circuit in the brain. A goal of cognitive behavioral therapy is to reduce these kinds of hostile biases. Preliminary data by the PI suggests a 12- session cognitive behavioral aggression treatment (CBAT) may help reduce aggressive behavior and underlying hostile biases associated with affective aggression. To assess the efficacy of this treatment, 120 adults with high levels of anger and aggression will receive 12 sessions of either CBAT or supportive psychotherapy. All subjects will monitor their anger and aggressive behavior throughout the treatment electronic diaries. Subjects will also complete questionnaires and computer tasks to assess anger, hostile biases and related processes 1-week before treatment begins, and again 1-week, 6-months and 1-year after treatment ends. In addition, to understand the effects of CBAT on the brain, subjects will have their brains scanned (functional Magnetic Resonance Imaging) while they look at emotional pictures and complete computer tasks. The brain scans will occur once before treatment starts and once after treatment ends.

Our hypotheses are:

1. CBAT will reduce anger, aggression and hostile biases more than supportive therapy.
2. CBAT will decrease limbic activation and increase prefrontal activation to emotional pictures more than supportive therapy.


Eligibility Criteria:
Inclusion Criteria:

* Three or more acts of physical aggression (assault / property destruction) in past six months
* Aggression related distress and/or impairment
* Meets Criteria for Intermittent Explosive Disorder

Exclusion Criteria:

* Life History of DSM-IV Axis Bipolar disorder, Schizophrenia, Delusional disorder, Organic disorder, or Mental Retardation
* Current DSM-IV Major Depressive Episode, Alcohol Dependence or other Drug Dependence
* Current (past month) psychotropic medication use
* Current severe suicidal or homicidal ideation necessitating immediate medical intervention
* Current pregnancy or nursing, or existence of any medical condition that would deem the subject ineligible to undergo an fMRI (e.g., metal pins)
* Two consecutive positive Expired Breathalyzer Alcohol or Urine Drug toxicological screens
* Unable or unwilling to cooperate with study protocol (e.g., keep appointments, complete rating forms, read and understand informed consent).
Population Pharmacokinetics and Pharmacodynamics Modeling to Optimize Dosage Regimen of Levofloxacin

Levofloxacin, a fluoroquinolone antibiotic, is the optical S-(-) isomer of ofloxacin with a broad spectrum of activity. In common with other fluoroquinolones, the main pharmacokinetic/pharmacodynamic (PK/PD) index that correlates with its therapeutic efficacy is the area under the plasma time-concentration curve/the minimum inhibitory concentration ratios.

The aims of the study were to:

1. reveal the population pharmacokinetics, and
2. assess the efficacy of various dosage regimens in achieving the probability of target attainment (PTA) and the cumulative fraction of response (CFR) of levofloxacin when oral levofloxacin was prescribed as the switching therapy after intravenous levofloxacin treatment.

The study was conducted in 45 healthy volunteers. Each subject received one 500 mg tablet of levofloxacin, after which PK studies were carried out, using a Monte Carlo simulation to determine the PTA. By referral to the EUCAST MIC distributions database, the dosage regimens were predicted to achieve CFR greater than or equal to 90%.


Eligibility Criteria:
Inclusion:

* normal hematologic
* normal hepatic
* normal renal functions
* non-smoking
* non-alcoholic
* non-obese

Exclusion:

* pregnant or lactating women
* any chronic medications