cyrilzakka/clinical-trials huggingface dataset:
Detection of Occult Paroxysmal Atrial Fibrillation After Stroke Using Prolonged Ambulatory Cardiac Monitoring

About one-third of patients with stroke have no documented cause for the cerebrovascular event (known as cryptogenic strokes). Atrial fibrillation is a common cause of stroke, but when transient (paroxysmal) it may remain undiagnosed. Recent data suggest that occult paroxysmal atrial fibrillation may be identified in patients with cryptogenic strokes using prolonged ambulatory cardiac rhythm monitors.

The investigators designed this study pursuing the following goals:

1. To determine the prevalence of occult paroxysmal atrial fibrillation in patients with cryptogenic stroke using long-term mobile cardiac outpatient telemetry.
2. To compare this prevalence to that found in a control group with stroke of known, non-cardioembolic cause.
3. To look for clinical, laboratory, echocardiographic, and imaging data that serve as risk factors for occult paroxysmal atrial fibrillation in patients with cryptogenic stroke.
4. To examine the utility of mobile cardiac outpatient telemetry, a relatively new diagnostic tool, in the evaluation of patients with cryptogenic stroke.


Eligibility Criteria:
Inclusion Criteria:

* Stroke or TIA within previous 3 months
* Stroke work up including: EKG, serum lipids, serum TSH, TTE or TEE, brain CT and/or MRI, Vascular Evaluation of head and neck using any combination of ultrasound, MRA, CTA, and conventional angiography

Exclusion Criteria:

* Documented history of atrial fibrillation or flutter
* PFO closure planned before conclusion of the monitoring period
* Incomplete stroke work up
Gastric Bypass and Peripheral Activity of the Endocannabinoid System

The aim of the study is to precise the effect of a large amount of weight loss induced by gastric bypass on the endocannabinoid system (plasma and adipose tissue) of morbidly obese patients and to determine the influence of a gastric bypass surgery compared to a lifestyle intervention with equivalent weight loss on the endocannabinoid system

Dysregulation of the endocannabinoid system has been associated with the development of obesity, metabolic and cardiovascular disorders in both animals and humans.

Obese patients, especially those with abdominal obesity, have significantly higher levels of endocannabinoids. No influence of moderate (5%) body weight loss (induced either by diet intervention or sibutramine) on the peripheral activity of the endocannabinoid system gastric bypass (GB) surgery is the most efficient treatment of obesity Hormonal pathways may participate to the weight reducing effect of the procedure.The endocannabinoid system is present in the gastrointestinal tract.

In animals, sustained weight loss after GB is characterized by reduction of endocannabinoids levels.

The endocannabinoid levels will be studied (baseline and after stimulation) in:

* Normal-weight subjects
* Obese subjects before and after gastric bypass surgery
* Obese subjects before and after a lifestyle intervention

Eligibility Criteria:
Inclusion Criteria:

* Arms 1 and 2:
* Age between 18 and 60
* BMI \> 40kg/m² or at least 30kg/m² with complication
* Medical follow up before surgery
* Patients that engaged themselves to a long medical follow up
* Efficient contraception
* Written, informed consent of each subject before the beginning of the study
* Arm 3:
* Age between 18 and 60
* BMI between 18 and 25 kg/m²
* Stable weight over the 3 past months
* Restrain score \<4 disinhibition \<6and hunger \> 4 at the TFEQ
* No job in the endocrinology department
* Written, informed consent of each subject before the beginning of the study

Exclusion Criteria:

* Arms 1,2 and 3
* No care of obesity before inclusion
* Incapacity of the patient to follow a medical follow up
* Drug or alcohol abuse
* Urine test result positive for THC
* Threaten life diseases
* Pregnancy, breast feeding
* Smoking
Real-World Practice Patterns and Outcomes of Lower-Risk Myelodysplastic Syndrome Patients in Japan

The purpose of this study is to describe the treatment patterns, clinical outcomes, healthcare resource utilization (HCRU) and medical costs of lower-risk myelodysplastic syndromes patients in Japan.


Eligibility Criteria:
Inclusion Criteria:

* Participants with at least one definitive myelodysplastic syndrome (MDS) diagnosis as per the 10th Revision of the International Statistical Classification of Diseases and Related Health Problems (MDS; ICD10: D46.X) between 01-May-2017 and 31-Jan-2022
* Participants with confirmed low-risk MDS by International Prognostic Scoring System (IPSS) or Revised International Prognostic Scoring System (IPSS-R) during baseline as follows:

  * Record of low (0 points) or intermediate-1 (\>0 to 1 point) MDS according to IPSS scoring; or
  * Record of very low (≤1.5), low (\>1.5-3), or intermediate (\>3-4.5) MDS according to IPSS-R scoring; or
  * Mention of very low, low, intermediate, intermediate-1, or lower risk MDS in the Electronic Medical Records (EMR)
* Participants with a record of a confirmed bone marrow procedure (bone marrow aspiration code D404-00 and/or bone marrow biopsy code D404-02) during baseline period

Exclusion Criteria:

* Participants not meeting the inclusion criteria
* Participants \<18 years of age at index date
* Participants who have a look back period \<30 days from initial myelodysplastic syndrome diagnosis date
A Clinical Trial to Evaluate the Efficacy and Safety of Anotinib Hydrochloride Capsule Combined With Epirubicin Hydrochloride Versus Placebo Combined With Epirubicin Hydrochloride in First-line Treatment of Advanced Soft Tissue Sarcoma

A multicenter, randomized, double-blind, parallel-controlled Phase III trial to evaluate the efficacy and safety of anotinib hydrochloride capsule combined with epirubicin hydrochloride versus placebo combined with epirubicin hydrochloride in first-line treatment of advanced soft tissue sarcoma


Eligibility Criteria:
Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
* Life expectancy \>=3 months.
* Female patients of childbearing age should agree to use contraceptive measures during the study period and for at least 6 months after study is stopped; male patients should agree to use contraception during the study period and for at least 6 months after study is stopped.
* Understood and signed an informed consent form.

Exclusion Criteria:

* Diagnosed and/or treated additional malignancy within 5 years before the first dose.
* With factors affecting oral medication.
* Received major surgical treatment, open biopsy or obvious traumatic injury within 4 weeks before the first dose.
* A history of psychotropic drug abuse or have a mental disorder.
* Any severe and/or uncontrolled diseas.
* Has received Chinese patent medicines with anti-tumor indications within 2 weeks before the first dose.
* Has participated in other clinical studies within 4 weeks before the first dose.
* According to the judgement of the investigators, there are other factors that subjects are not suitable for the study.
Intervention Social Anxiety: Combining Parent-child Treatment

The aim of this pilot project is to investigate a treatment program for children with social anxiety, in which children and their parents, parallel to each other, follow separate evidence-based interventions. The added value of this pilot project is that the investigators are examining how both programs interact when offered simultaneously.

After a diagnostic trajectory and a 2-week reflection period, children and their parents are invited to come into the lab for baseline 1. During baseline 1, children and their parents will be interviewed and they will fill in some questionnaires. They will then be randomly assigned to a 2-, 4-, or 6-week waiting period. During this waiting period they will fill in Experience Sampling Method (ESMs) daily, every other week. One week before the end of the waiting period, baseline 2 will take place. After the waiting period children and their parents will start their separate treatments in parallel. Children will get an individually tailored cognitive behavioural therapy (CBT)-protocol for social anxiety and parents will get SPACE. In the treatment period, they will fill in ESMs daily. There is another assessment with interviews and questionnaires at mid-treatment (after 6 sessions) and post-treatment (after 12 sessions), as well as 1- and 2-months after treatment has ended. After the treatment period, the frequency of the ESMs will go back to daily every other week.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis social anxiety
* At least 1 parent is willing to participate

Exclusion Criteria:

* Currently under treatment for anxiety
* Other complaints that need attention first
* Not understanding instructions/treatment
Treatment for Specific Phobias in Children

This study will compare the effectiveness of three treatments in reducing symptoms of phobia in children and adolescents.

Children with specific phobias may experience academic, social, and personal distress, as well as interference in day-to-day activities. One-Session Treatment has been found a rapid and effective treatment for adults with phobic disorders. However, its utility in the treatment of childhood phobia has not been examined.

Participants are randomly assigned to 1 of 3 groups: a one-session treatment group, an education/support group, and a waitlist control group. The one-session treatment group is directly exposed to a phobia object or situation during a 3-hour treatment session. In the education/support group, children are given information about fear and phobias and are taught how to deal with them through workbook activities. Children who participate in the one-session treatment group or the education/support group are assessed 1 week post-treatment and again after 6 months. Participants with improved symptoms have a 1-year follow-up. Participants with phobias that persist at 6 months are encouraged to participate in alternative treatment. Waitlist control participants are assessed pre-treatment and 1 month post-treatment. Those who continue to have phobias at the 1-month assessment are randomly assigned to 1 of the 2 active treatments.

Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis of specific phobia disorder

Exclusion Criteria:

* Mental retardation
* Developmental disabilities
* Suicide threat
Respiratory Morbidity Among Children Who Were Born by Elective Cesarean Section After 37-38 Weeks vs. 39 Weeks and More

Background: It is known that after Cesarean section is correlated with respiratory complication more, if done after 37-38 week of gestation than if done after 39 weeks or more.

Goal: The aim of the current study is to find out if these respiratory complications extend to later life.

Methode: Reviewing the patients' medical file, and collecting data about respiratory complication.

Background: It is known that after Cesarean section is correlated with respiratory complication more, if done after 37-38 week of gestation than if done after 39 weeks or more. We have already conducted a study about this topic, and published our results.

Goal: The aim of the current study is to find out if these respiratory complications extend to later life.

Method: Reviewing the patients' medical file, and collecting data about respiratory complication. We will use the same patients we used at the first study. Respiratory complications are defined as diagnosis of asthma, treatment by inhalations or systemic steroids, or consultation by pulmonologist.

Eligibility Criteria:
Inclusion Criteria:

* Children born in 2007-2009 our medical center by elective Cesarean section according to a list of IDs we have.

Exclusion Criteria:

* Children with respiratory congenital defect that was not known at the first week of life.
Role of Eosinophil in Fibrogenesis of Systemic Sclerosis

Eosinophils are involved in tissue remodeling and fibrosis in many inflammatory diseases. Systemic sclerosis (SSc) is an autoimmune disease with fibrotic skin and lung complications. The profibrosing properties and data from the SSc literature suggest a possible role of the eosinophils in the process of fibrogenesis of SSc.

it will assess the activation state of blood eosinophils in SSc patients compared to healthy controls (ECP production in vitro, surface activation markers, whole transcriptome array, ..).

it will also study skin eosinophils and their recruitment (extracellular eosinophil granules, eotaxins production in skin, ..)

Eligibility Criteria:
Inclusion Criteria:

* For SSc patients:
* Meeting the 2013 ACR-EULAR criteria for diffuse SSc (n = 20) and limited SSc (n = 20)
* Having signed the informed consent
* Eosinophils ≥ 0.1 G / L on the last blood test (\<3 months)

For healthy subjects:

* Without chronic pathology requiring long-term treatment
* Eosinophils between 0.1 and 0.4 G / L on recent blood test (\<3 months)

Exclusion Criteria for patients and controls:

* Patient with an infection, state of emergency or progressive neoplastic pathology
* Pregnant or lactating women
* History of atopy (allergic asthma, atopic eczema, allergic rhinitis, allergic conjunctivitis)
* Allergy to local anesthetics (for scleroderma patients only)
* Taking into account a minimum weight of 50 kg and in the absence of cardiorespiratory effects of scleroderma, only patients with at least 10 g of hemoglobin will be included
Validating Interventions for Diverse Adolescents

The purpose of this study is to compare a culturally adapted and a non-culturally adapted group-based substance abuse treatment with Latino adolescents.


Eligibility Criteria:
Inclusion Criteria:

* Adolescent between 13-18 years of age
* Parental consent
* Adolescent speaks English and Spanish
* Adolescent assent to participate in treatment and assessments
* Adolescent meets either DSM-IV diagnostic criteria for substance abuse or dependence
* Adolescent identifies as Hispanic

Exclusion Criteria:

* Adolescent younger than 13 or older than 18 years of age
* Adolescent requires higher level of care than what is provided in study
* Adolescent speaks only English or Spanish
* Parental consent not obtainable
* Adolescent does not assent to study
* Adolescent is overtly psychotic, severely depressed/suicidal, and/or presents with other mental disorder that will limit participation in group treatment
* Adolescent has completed substance abuse treatment elsewhere in the past 90 days
* Adolescent does not identify as Hispanic
TEOSYAL® RHA Ultra Deep and Perlane-L® for the Correction of Nasolabial Folds

The purpose of this study is to compare the effectiveness and safety of TEOSYAL® RHA Ultra Deep versus Perlane-L® in the treatment of moderate to severe nasolabial folds. This is a controlled, randomized, double-blinded, within subject (split-face), multicenter, prospective clinical study.


Eligibility Criteria:
Inclusion Criteria:

* Outpatient, male or female of any race, 22 years of age or older; female subjects of childbearing potential must have a negative Urine Pregnancy Test and practice a reliable method of contraception;
* NLFs classified as WSRS grade 3 or 4 (same score for each side);
* Willing to abstain from facial aesthetic procedures/therapies that could interfere with study evaluations;
* Able to follow study instructions and likely to complete all required visits;
* Signed informed consent and HIPAA form.

Exclusion Criteria:

* Female subjects that are pregnant, breast-feeding or of childbearing potential and not practicing reliable birth control;
* Known hypersensitivity/allergy to any component of the study devices;
* Known sensitivity to local anesthetics of the amide type, history of multiple severe allergies, history of anaphylactic shock;
* Known susceptibility to keloid formation, hypertrophic scarring or clinically significant skin pigmentation disorders;
* Clinically significant active skin disease within 6 months;
* History of active chronic debilitating systemic disease;
* History of connective tissue disease;
* History of malignancy (excl. non-melanoma skin cancer) within past 5 years;
* History of bleeding disorders;
* Need for clinically significant and continuous medical treatment within 2 weeks prior to first visit;
* Received/used a prohibited treatment/procedure within certain time periods (e.g., bioresorbable fillers, NSAIDS, ASA, high dose vitamin E, corticosteroids, interferon, anti-coagulation therapies, laser/light therapies, botulinum toxin injections (frontalis and glabella complex treatment permitted), prescription strength topical retinoids, facial peels, excisional facial surgery, clinically significant oral or maxillofacial surgery).
* Evidence of clinically significant alcohol or drug abuse, or history of poor cooperation, non-compliance with medical treatment, or unreliability
* Exhibit a physical attribute(s) that may prevent assessment or treatment of NLFs such as excessive facial hair, traumatic or surgical facial scars, and/or excessive hyperpigmentation in the treatment areas.
* A condition or situation that may put the subject at significant risk, confound the study results, or significantly interfere with the subject participation.
Chlorambucil Compared With No Further Therapy Following Anti-Helicobacter Therapy in Treating Patients With Low-Grade Lymphoma of the Stomach

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. It is not yet known whether chlorambucil is more effective than observation in treating low-grade lymphoma of the stomach.

PURPOSE: Randomized phase III trial to compare the effectiveness of chlorambucil with that of no further therapy following anti-Helicobacter therapy in treating patients with low-grade lymphoma of the stomach.

OBJECTIVES: I. Determine the efficacy and response rate of triple antibiotic therapy for Helicobacter pylori in the healing of lesions in patients with low grade gastric lymphoma. II. Assess the efficacy of chlorambucil in the prevention of relapse in patients after complete eradication of low grade gastric lymphoma. III. Determine the natural history of unresected or partially resected low grade gastric lymphoma treated medically.

OUTLINE: This is a randomized study. Patients are randomized to receive chlorambucil or placebo. Patients receive omeprazole daily for 1 week. Clarithromycin and tinidazole are administered twice daily for 1 week for the eradication of H. pylori infection. Patients are assessed every 2-3 months by endoscopy. Patients may receive a maximum of 3 courses of treatment every 2-3 months. Other regimens may be used if full eradication of H. pylori is not achieved. Patients who achieve complete response (eradication of H. pylori) are randomized to receive oral chlorambucil or placebo daily for 14 days. Treatment is repeated every 28 days for 6 courses. Patients are followed every 6 months for 2 years, then yearly thereafter.

PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Endoscopically diagnosed, unresected, partially resected, or completely resected low grade (stage I) gastric lymphoma Prior diagnosis of H. pylori infection No nodal metastases Microbiological evidence of current H. pylori infection required No pathological evidence of enlarged abdominal lymph nodes by CT scan Gastroscopic ultrasound evidence of enlarged nodes allowed, if CT scan normal

PATIENT CHARACTERISTICS: Age: 16 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics
Positive Expiratory Pressure (PEP) and Continuous High-frequency Oscillation (CHFO) on Lung RECRUITment Using Electrical Impedance Tomography (EIT) - The PEP-RECRUIT Study

This single-center observational study aims to assess the effects of continuous high-frequency oscillation (CHFO) and continuous positive expiratory pressure (CPEP) therapy on lung recruitment using electrical impedance tomography (EIT) in spontaneously breathing patients admitted to the intensive care unit.


Eligibility Criteria:
Inclusion Criteria:

* Patients who require pulmonary expansion and airway clearing as per clinical indication
* Patients who provide valid informed consent according to local regulations
* PaO2/FiO2 \< 200 mmHg at inclusion
* Patient on the Airway Care Score (ACS) \< 7

Exclusion Criteria:

* Refuse to participate
* Age \< 18 years
* Hemodynamic instability, defined as systolic arterial pressure \< 90 mmHg or mean pressure \< 60 mmHg
* Contraindication to using an EIT (i.e., pacemaker or defibrillator)
* Inability to properly position the EIT device for anatomical reasons
Neuroprotection in Patients Undergoing Aortic Valve Replacement

To evaluate the efficacy and safety of embolic protection devices to reduce ischemic brain injury in patients undergoing surgical aortic valve replacement (AVR).

This is a multicenter randomized trial in which patients diagnosed with calcific aortic stenosis (AS) with planned AVR will be randomized to 1) the treatment arm of the Edwards Life Science filter and cannula or the filter as a stand alone with any cannula or 2) to the treatment arm of the CardioGard cannula versus 3) standard care in a 1:1:1 ratio.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 60 years
* Planned and scheduled surgical aortic valve replacement via a full or minimal-access sternotomy (using central aortic perfusion cannulae) for calcific aortic stenosis with a legally marketed valve
* No evidence of neurological impairment as defined by a NIHSS ≤1 and modified Rankin scale (mRS) ≤ 2 within 7 days prior to randomization
* Ability to provide informed consent and comply with the protocol

Exclusion Criteria:

* Contraindication to legally marketed embolic protection devices (e.g. aneurysm of the ascending aorta, aortic trauma, porcelain aorta, known sensitivity to heparin)
* History of clinical stroke within 3 months prior to randomization
* Cardiac catheterization within 3 days of the planned aortic valve replacement
* Cerebral and or aortic arch arteriography or interventions within 3 days of the planned aortic valve replacement
* Active endocarditis at time of randomization
* Anticipated inability to tolerate or contraindication for MRI (e.g., known intolerance of MRI, permanent pacemaker at baseline or expected implantation of a permanent pacemaker)
* Any other concomitant aortic procedure such as root replacement
* Concomitant surgical procedures other than CABG, mitral annuloplasty, left atrial appendage (LAA) excision or exclusion, atrial septal defect (ASD) closure or patent foramen ovale (PFO) closure
* Clinical signs of cardiogenic shock or treatment with IV inotropic therapy prior to randomization
* Concurrent participation in an interventional (drug or device) trial