cyrilzakka/clinical-trials huggingface dataset:
Comparison of the Safety and Pharmacokinetics of Two SAR153191 (REGN88) Drug Products in Rheumatoid Arthritis Patients

Primary Objective:

Assess the comparative safety and tolerability of two SAR153191 (REGN88) drug products after a single dose administration in rheumatoid arthritis patients.

Secondary Objective:

Assess the comparative pharmacokinetic profiles of the two SAR153191 (REGN88) drug products after a single dose administration in rheumatoid arthritis patients.

The duration of the study period per subject is 5-7 weeks broken down as follows:

* Screening: 1 to 14 days,
* Treatment: 1 day (2 overnight stays at the study site),
* Follow-up: up to 5 weeks after dosing (an additional outpatient follow-up may be scheduled depending on the last results).

Eligibility Criteria:
Inclusion criteria:

* Diagnosis of rheumatoid arthritis (RA) \> or = 3 months duration.
* Treated for a minimum of 12 weeks with Methotrexate (MTX) prior to randomization. Treatment must be continued on a stable dose for the duration of the study.

Exclusion criteria:

* Autoimmune disease other than RA.
* History of acute inflammatory joint disease other than RA.
* Surgery within 4 weeks prior to the screening visit or with planned elective surgery within the next 3 months.
* Latent or active tuberculosis.
* Fever (≥38 C) or persistent chronic or active recurring infection requiring treatment with antibiotics, antivirals, or antifungals within 4 weeks prior to the screening visit, or history of frequent recurrent infections.
* Received administration of any live (attenuated) vaccine within 3 months prior to the randomization visit (eg, varicella-zoster vaccine, oral polio, rabies).
* Received tuberculosis vaccination within 12 months prior to screening
* Prior therapy with a Tumor Necrosis Factor (TNF) antagonist or any other biologic agents within 3 months prior to inclusion.
* Known latex sensitivity.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Impacts of a Continuing Education Activity Targeted at COPD Case Managers

This study aims to compare the impacts of two versions of a continuing education activity targeted at COPD case managers on educational outcomes: 1) participation; 2) satisfaction; 3) learning; 4) competence; 5) performance; 6) patient health outcomes.

This study has a quasi-experimental design. The study is based on the Expanded Outcomes Framework for Planning and Assessing Continung Medical Education by Moore (2009). One groupe of participants will attend the former version of the continuing education activity, and the other group will attend its new version.

Data will be collected at T0 (before the activity, which will be held at T1); at T2 (immediately after the activity); at T3 (1-month post-activity); at T4 (2-month post-activity); at T5 (4-month post-activity); at T6 (10-month post-activity).

Participation will be assessed at T0. Satisfaction will be assessed at T2. Learning will be assessed at T0 and T3. Competence will be assessed at T2. Performance will be assessed at T4. Patient health outcomes will be assessed at T5 and T6.

Eligibility Criteria:
Inclusion criteria for attendees:

* Attending the continuing education activity
* Providing patient education to individuals with COPD in professional setting.

Exclusion criteria for attendees:

* None

Inclusion criteria for COPD patients:

* Doctor-diagnosed COPD.

Exclusion criteria for attendees:

* None
Pharmacological Regulation of Fat Transport in Metabolic Syndrome

The purpose of this study is to determine whether atorvastatin and fenofibrate are effective in the treatment of lipid disorders in obese, insulin resistant subjects.

Insulin resistance is a heterogeneous metabolic disorder of complex etiology. It underpins dyslipoproteinemia, a key feature of the metabolic syndrome (MetS) that independently predicts cardiovascular disease (CVD). Hypertriglyceridemia, the most consistent lipid disorder in subjects with obesity and type 2 diabetes mellitus, is chiefly a consequence of overproduction and delayed clearance of triglyceride-rich lipoproteins (TRLs). Although the precise mechanisms involved are incompletely understood, experimental and clinical evidence suggests that elevated apolipoprotein (apo) C-III may play a crucial role in the dysregulation of TRL metabolism. investigating the effects of these agents on VLDL-apoC-III kinetics. In this study, we aimed to examine the effect of two lipid-regulating agents, atorvastatin and fenofibrate on VLDL-apoC-III transport. We hypothesized that atorvastatin and fenofibrate would have similar effects on apoC-III transport by decreasing the production and increasing the catabolism of VLDL-apoC-III.

Eligibility Criteria:
Inclusion Criteria:

any three of the followings

* waist circumference \>102cm
* triglycerides \>1.7 mmol/L
* HDL-cholesterol \<1.05 mmol/L
* blood glucose \>6.1 mmol/L
* blood pressure \>130/85mmHg

Exclusion Criteria:

* plasma cholesterol \>7mmo/L
* triglycerides \>4.5mmo/L
* diabetes mellitus (defined by oral glucose tolerance test)
* CVD
* consumption of \>30g alcohol/day
* use of agents affecting lipid metabolism
* APOE2/E2 genotype, macroproteinuria
* creatinaemia (\>120umol/L)
* hypothyroidism
* abnormal liver and muscle enzymes.
Transpulmonary Pressure Guided Mechanical Ventilation Weaning in Obesity

This study will look at whether accounting for the amount of pressure generated by the chest wall and abdomen in a obese patient, using a measurement called transpulmonary pressure, can help shorten the amount of time patients spend on the ventilator. By decreasing the amount of time patients spend on the ventilator, they are less likely to develop complications such as infections, weakness or more procedures.

Managing obese patients on the ventilator can be difficult due to the changes in their respiratory mechanics with little evidence as to best practices. This research will assess the utility of transpulmonary pressures in guiding mechanical ventilation in obese patients. This study with specifically look at whether using transpulmonary pressure guided positive end expiratory pressure (PEEP) titration for ventilation and spontaneous breathing trials (SBT) will shorten the time to liberation for obese patients on invasive mechanical ventilation for respiratory failure. The transpulmonary pressures will be calculated daily for all patients. Patients will also be assessed daily for readiness for SBT. In the intervention group, subjects' PEEP will be titrated to achieve an end expiratory transpulmonary pressure of 0-2 cm H2O. This PEEP will be used for the SBT and clinicians will be encouraged to keep their patients on this PEEP after the SBT if they are not extubated. In the control group, patients will also be assessed daily for SBT readiness but will be managed with standard set pressures of 5 to 10 cm H2O of PEEP and 5 to 8 cm H2O of pressure above PEEP. The primary team can perform a T piece trial prior to extubation as clinically indicated.

Eligibility Criteria:
Inclusion Criteria:

* on invasive mechanical ventilation for respiratory failure for \< 48 hours
* obese class II or higher (BMI greater than or equal to 35.0 kg/m2)

Exclusion Criteria:

* contraindications to esophageal balloon catheter placement including esophageal, nasofacial, gastrointestinal abnormalities and platelets \<10,000/microliter
* known pleural disease such as persistent pneumothorax, pleural effusion, or pleurodesis
* neuromuscular disease
* requires chronic mechanical ventilation prior to enrollment
* severe neurologic injury
* known difficult airway
* life expectance is less than 48 hours
Postural Control Among Children with and Without Dyslexia

As Chinese-speaking children with dyslexia typically have different cerebellar sign behavior from non-Chinese-speaking counterparts, this study compared the effect of visual occlusion on the static balance between dyslexic and non-dyslexic children using the Chinese language.


Eligibility Criteria:
Inclusion Criteria:

* 1.Normal IQ(\>85, WISC-III)
* 2.Children with dyslexia assessed by standard tools, performed by psychological-teachers of special education

Exclusion Criteria:

* 1.Attention deficit hyperactivity disorder(ADHD)
* 2.Neurological or psychiatric abnormalities
* 3.Developmental coordination disorder(DCD)
Preventing Excessive Gestational Weight Gain Via Short Mobile Messages in WIC

The objective of this trial was to investigate the effect of educational short message service (SMS), or text messages, on gestational weight gain (GWG) in a low-income population.


Eligibility Criteria:
Inclusion Criteria:

* 15-20 weeks gestational age and 18 years of age or older at time of recruitment
* body mass index (BMI) of 25-45 kg/m2 in the first trimester
* possession of a cellular phone with the ability to receive text messages without a charge

Exclusion Criteria:

* conditions requiring a special diet
* multiparous pregnancies
* unable to consent to participate
* unwilling to be randomized
Eradication Rate Between 1- and 2-Week Helicobacter Pylori Eradication Therapy

It is recommended as the first line treatment regimen to eradicate Helicobacter pylori (HP), 7 or 14 days treatment of proton pump inhibitor (PPI) based triple therapy consisting of one PPI and two antibiotics, clarithromycin and amoxicillin. In the case of treatment failure, 7 or 14 days of quadruple therapy (PPI＋metronidazole＋tetracycline＋bismuth) is recommended.

This study aims to investigate which duration would be better for eradication of HP. The study design is a randomized controlled trial. The patients were randomly assigned to 7 days or 14 days treatment groups. Primary endpoint was the eradication rate of PPI based triple therapy. Secondary endpoints were to compare the rate of drug compliance and side effects in both groups.

The recommended duration of triple therapy is typically 10 to 14 days in the United States and 7 days in Europe. In Korea, it is recommended as the first line treatment regimen, 7 or 14 days treatment of proton pump inhibitor (PPI) based triple therapy consisting of one PPI and two antibiotics, clarithromycin and amoxicillin. In case for treatment failure which is often related to Helicobacter pylori (HP) resistance to clarithromycin or metronidazole, bismuth-based quadruple therapy is commonly used as second-line therapy, however, the eradication rates was widely ranged according to the treatment duration.

The objective of the study is to investigate whether treatment duration would affect the eradication rate of HP as a PPI based triple therapy (1st line therapy) and a bismuth-based quadruple therapy (2nd line therapy).

Eligibility Criteria:
Inclusion Criteria:

* Peptic ulcer including ulcer scar
* Early gastric cancer
* Gastric mucosa-associated lymphoid tissue lymphoma

Exclusion Criteria:

* operation history
* liver cirrhosis
* chronic kidney disease
* pregnancy
Anosmia Rehabilitation in Patients Post Coronavirus Disease (COVID 19)

The study will be a randomized controlled trial, involving patients with hyposmia/anosmia of onset immediately after an upper respiratory viral illness, assigned to three distinct study arms. Nasal irrigations will be prescribed to all three groups (BID). In addition, one arm will receive a paper hand-out about post-viral anosmia with instructions to smell common household items (current care) and act as a control group. The second group will receive an essential oil retraining kit, whereas the third group will receive the same olfactory training kit and a prescription to use budesonide with the nasal irrigations. Olfactory scores will be tested at the enrollment, 3 months and at 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Adults 18 years of age or older
* Hyposmia/anosmia of onset immediately after an upper respiratory viral illness confirmed on Snap n' Sniff threshold testing,
* Capable, in the opinion of the primary investigator, of providing informed consent to participate in the study. Participants are required to sign an informed consent form indicating they understand the purpose and nature of the study, and that they are willing to participate.

Exclusion Criteria:

* active cigarette smoker
* chronic rhinosinusitis
* head trauma with loss of consciousness
* inability to read/understand English
* previous hyposmia/anosmia complaint
* pregnancy
* previous sinus
* skull base or brain surgery
* current participation in another clinical trial at the time of initial visit
Haploidentical Hematopoietic Stem Cell Transplantation With Early ATG and Low Dose Post-transplant Cyclophosphamide

Aim of this study is to investigate the effect of early administration of anti-thymocyte globulin and post-transplant low-dose cyclophosphamide in heploidentical hematopoietic stem cell transplantation.

Hematopoietic stem cell transplantation from a haploidentical donor (haplo-HCT) are increasingly used in patients lacking a matched donor, but the optimal strategy needs to be defined. This study aims to investigate the outcome of haplo-HCT with early antithymocyte globulin and low dose posttransplant cyclophosphamide (ATG/LD-PTCy) in a single center.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing haploidentical hematopoietic stem cell transplantation with ATG and low-dose post-transplant cyclophosphamide conditioning at the department of pediatrics, Samsung Medical Center.

Exclusion Criteria:

* A clinical trial subject (legal representative, if applicable) who do not consent or is unable to give written consent.
Pilot Pharmacokinetic Clenil Study With AeroChamber Plus™ or Volumatic™ Spacer Devices

The purpose of this study is to evaluate, at steady-state, the systemic exposure and the lung deposition of B17MP (active metabolite of BDP) as AUC0-12h,ss and Cmax,ss, after inhalation of BDP (Clenil® Modulite®) with the AeroChamber Plus™ spacer device or with the Volumatic™ spacer device without or with charcoal block.


Eligibility Criteria:
Inclusion Criteria:

* Male or non-pregnant female patients aged 18-65 years included.
* Diagnosis of asthma according to GINA guidelines 2009 made at least 6 months prior to screening.
* Patients already treated with a dose of BDP or equivalent up to 2000 µg/day.
* FEV1 ≥ 60% of predicted for the patient's normal value at screening and randomisation

Exclusion Criteria:

* Patients treated with oral or parenteral corticosteroids in the previous 8 weeks (12 weeks for parenteral depot corticosteroids) before screening visit.
* Exacerbation of asthma symptoms or hospitalization due to asthma exacerbation within the previous one month before screening until randomisation.
* Lower respiratory tract infection within one month prior to screening.
* Diagnosis of COPD as defined by the current GOLD 2009 (Global Initiative for Chronic Obstructive Lung Disease) Guidelines.
* Significant medical history and/or treatments for cardiac, renal, neurological, hepatic, endocrine diseases, or any laboratory abnormality indicative of a significant underlying condition, that may interfere with patient's safety, compliance, or study evaluations, according to the Investigator's opinion.
* Treatment with a xanthine derivative (e.g. theophylline) formulation in the 4 weeks prior to screening.
* Any enzyme inducing or inhibiting drug (from 8 weeks before screening visit)
* Patients who received any investigational new drug within the last 8 weeks before the screening. The patients cannot participate in another clinical study at the same time as the present study.
* Blood donation (450 mL or more)or significant blood loss less than 12 weeks before the first intake of study drug.
Percutaneous Treatment of Carpal Tunnel Syndrome With Scan

The objective of the study is to evaluate in patients suffering from carpal tunnel syndrome resistant to medical treatment, clinical course after percutaneous treatment under ultrasound guidance. 40 patients will be included in the study. The following parameters will be evaluated: patient satisfaction, pain, functional disability, quality of life and time to return to work. The medico-economic aspect will be analyzed.

Ultrasound analysis of Carpal tunnel is used for many years, especially for diagnostic purposes. Investigators have shown, first by a study of 104 cadavers that it was possible to reduce the opening by making the gesture under ultrasound guidance and to perform the procedure under local anesthesia. Then investigators performed an open study of 25 patients confirming the absence of iatrogenic lesions with this new technique.

The percutaneous treatment of carpal tunnel syndrome under ultrasound guidance is a gesture of interventional radiology. One can envisage making this type of treatment in interventional radiology room which overcomes the operating room and thus reduce costs.

The objective of the study is to continue the study of percutaneous treatment of carpal tunnel syndrome under ultrasound guidance by an open study conducted in interventional radiology room.

Eligibility Criteria:
Inclusion Criteria:

* Patient older than 18 years who signed the informed consent.
* Patient with an Carpal Tunnel Syndrome

Exclusion Criteria:

* patient has already undergone surgery of Carpal Tunnel Syndrome
* Patient with contra-indications to anesthesia (heart failure, kidney, liver).
* Pregnant women
* alcoholics in weaning period
* Patient whose consent is altered or unable to get a safety procedure
* Patient with contra-indication to lidocaine
* Patient with contra-indication for the realization of ultrasound endoscopy (carpal tunnel syndrome secondary or anastomosis between the median and ulnar nerves: anastomosis Berritini)
Teenagers After London Terrorist Attack

* Context: Since March 2012, several terrorist attacks have been perpetrated in France (Toulouse, Montauban, Paris, Nice ...). In March 2017, 53 french teenagers were victims in a terrorist attack in London (Westminster Bridge).
* Main goal = to estimate the psycho-traumatic impact and to describe cares and management of high school students, victims of the terrorist attack in London on 2017, March the 22nd.
* 3 secondary objectives: 1) Clinical (occurrence of Post Traumatic Stress Disorders or other disorders); 2) Epidemiological (risk factors for developing disorders, avoiding care); 3) Preventive and therapeutic.

Inclusion criterion: 53 teenagers of Saint-Joseph high school (Concarneau, France) directly exposed to the terrorist attack.

Methodology: self questionnaires and heterogenous questionnaires; descriptive statistics (means +/- standard deviations; search for a significant difference according to traumatic symptomatology)

Eligibility Criteria:
Inclusion Criteria:

* 53 teenagers, from Concarneau (France) high school, directly exposed from London terrorist attack (22.03.2017).

Exclusion Criteria:

* All persons not directly exposed;
* Relatives of teenagers;
* 3 physically injured teenagers.
ENB Guided MWA for Early-stage Peripheral Lung Cancer

The objective of the study was to evaluate the efficacy and safety of electromagnetic navigation bronchoscopy (ENB) guided microwave ablation (MWA) for the treatment of early-stage peripheral lung cancer.

The study is designed as a multi-center prospective trial with one arm. There will be 5 centers participating the study. Patients diagnosed with early-stage non-small cell lung cancer (NSCLC) that are nonsurgical candidate will be enrolled in the study. Sixty patients are expected to be enrolled in the study. The purpose of the study is to evaluate the efficacy and safety of ENB guided MWA for the treatment of patients with early-stage nonsurgical NSCLC.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with peripheral lung nodules demonstrated to be NSCLC by pathology with the clinical stage of IA.
2. The length-diameter of the tumors are more than 8 mm and no more than 30 mm.
3. Patients are unsuitable for surgery assessed by multi-modality treatment and agree to the primary treatment of ablation.
4. Patients have good compliance and sign the informed consent.

Exclusion Criteria:

1. Patients cannot receive bronchoscopy for the severe cardiopulmonary dysfunction and other indications.
2. Patients have contraindications of general anesthesia.
3. Chest CT suggests that navigation bronchoscopy technology cannot guide treatment equipment to reach the peripheral lung lesion.
4. Chest CT or bronchoscopy shows that the bronchial lumen occlusion or deformation leading to the guided and treatment equipment cannot reach the peripheral lung lesion.
5. There are large blood vessels or important structures adjacent to peripheral lung lesion.
6. Researchers consider the patient do not fit for the study.
Anastomotic Leakage in Right Colectomy

Data of patients undergoing elective right colectomy for benign and malignant disease using an open or laparoscopic approach are to be collected in seven colorectal units among Austria for the period between January 2010 and December 2019. Demographic, peri- and postoperative data of patients were analyzed retrospectively.


Eligibility Criteria:
Inclusion Criteria:

* Patients with benign or malignant diseases in the right portion of the colon.
* elective surgery

Exclusion Criteria:

* emergent surgery
Tanglewood Trail Walking Program in Rural Kentucky 2017

The Tanglewood Trail Walking Program is a well-established community health initiative that encourages community members to walk approximately 1 mile to the Whitesburg Farmers Market each Saturday. The study aims to determine if walking to the market with a community health coach results in healthier options being selected at the market.

In the summer of 2017, community members of Whitesburg, KY were recruited to join the Tanglewood Trail Walking Program to the Whitesburg farmers market. Each Saturday, participants reported whether or not they walked the 1-mile trail to the farmers market and they reported which fruits and vegetables they purchased. The Walking Program was held June - Sept 2017. Participants completed questionnaires about fruit and vegetable consumption and physical activity. Participants also provided physical and biological measurements.

Although originally designed to compare data among walkers and non-walkers, the protocol was changed due to participant feasibility. Data were analyzed by comparing "low engagers" - those who walked to the market fewer than three times during the program - or "high engagers" - those who walked three or more times during the program. Data were collected at baseline and 3 months.

The data for years 2019 and 2020 of the Tanglewood to Trail walking program are registered separately in ClinicalTrials.gov.

Eligibility Criteria:
Inclusion Criteria:

* ability to walk 1 kilometer

Exclusion Criteria:

* pregnant
* institutionalized adults
* impaired consent ability
* prisoners