cyrilzakka/clinical-trials huggingface dataset:
Meditation-Based Stress Reduction in Rheumatoid Arthritis

The purpose of this study is to determine whether a mindfulness meditation-based stress reduction program is useful in relieving symptoms associated with rheumatoid arthritis (RA).


Eligibility Criteria:
Inclusion criteria:

* Confirmed diagnosis of RA, with doctor's letter or doctors' bill with ICD code 714;
* 18 years of age or older;
* Able to read and write English;
* Able to attend 15 course sessions and questionnaire sessions at Kernan Hospital in Baltimore;
* Willing to practice skills for 45 minutes to 1 hour per day, 6 days a week;
* Stable on rheumatoid medications for at least one month.

Exclusion criteria:

* Major psychiatric illness (bipolar disorder, multiple personality disorder, etc.);
* Active alcoholism or drug dependency;
* Scheduled for major surgery during the study period;
* Enrolled in randomized clinical trial for rheumatoid arthritis during the study period;
* Planning to move out of the area in the next 12 months;
* Unwilling to be enrolled in a control group;
* Use of assistive device other than a cane;
* Serious health condition(s) that the investigator determines would make it difficult to complete the 6 month study;
* Diagnosis of fibromyalgia.
Extension to a Study on the Efficacy and Safety of Vildagliptin Compared to Metformin in Drug Naive Patients With Type 2 Diabetes

This is a 52-week extension to a study to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to metformin in lowering overall blood glucose levels in people with type 2 diabetes who have not been previously treated with drug therapy to lower their blood sugar. The purpose of the extension study is to gather data on the long-term safety and effectiveness of vildagliptin in people with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Only patients successfully completing study CLAF237A2309 are eligible
* Written informed consent
* Ability to comply with all study requirements

Exclusion Criteria:

* Premature discontinuation from CLAF237A2309
* Other protocol-defined exclusion criteria may apply
Mindfulness-Oriented Recovery Enhancement for Chronic Pain Patients Receiving Opioid Therapy

Persons suffering from chronic pain who are treated with long-term opioid therapy are at risk of misusing prescription opioids and developing opioid addiction. Moreover, long-term use of opioids may result in hyperalgesia, which exacerbates opioid craving and consumption. Mindfulness interventions have been shown reduce chronic pain symptoms, addictive processes, and substance use. The investigators hypothesize that relative to a support group control condition, participation in a novel mindfulness-oriented cognitive intervention, Mindfulness-Oriented Recovery Enhancement (MORE), will result in improved well-being and decreased pain, opioid craving, and opioid misuse behaviors among chronic pain patients receiving opioid therapy.

Few behavioral treatments target the cognitive-affective mediators of opioid misuse and addiction in chronic pain patients. As such, novel, multimodal interventions are needed to effectively target key mechanisms in the risk chain from chronic pain to opioid misuse and addiction. The secondary aim of this study is to explore possible cognitive, affective, and psychophysiological mediators of intervention effects on pain, opioid craving, opioid misuse behaviors, and well-being.

Eligibility Criteria:
Inclusion Criteria:

* chronic pain diagnosis (ICD-9 diagnoses 338.xx)
* treatment with prescription opioids for \> 3 months

Exclusion Criteria:

* prior mindfulness training
* persons who are experiencing acute opioid withdrawal
* suicidal ideation
* psychosis
The Effect of Spa Treatment on Chronic Obstructive Pulmonary Disease

The primary objective of this study is to measure and compare the number of exacerbations (moderate or severe) between the two groups of randomized patients with and without thermal treatment). An exacerbation is defined by an increase in symptoms which justifies a unscheduled medical action: increased daily treatment and / or use of corticosteroids, and / or antibiotic therapy. Exacerbations are documented via prescriptions, hospitalisation reports or unscheduled visits.


Eligibility Criteria:
Inclusion Criteria:

* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient must have chronic obstructive pulmonary disease
* Obstructive ventilation problem: Tiffeneau index (expiratory volume in one second / slow vital capacity) \< 70%
* Expiratory volume in one second \< 80% of the theoretical value
* Reversibility \< 12% after inhalation of bronchodilators
* Smokers or ex smokers
* Available for study monitoring
* Has access to diagnostic, medical and therapeutic care according to the best, current criteria (see the recommendations of the French Language Pseumologist Society)

Exclusion Criteria:

* The patient is participating in another study
* The patient has participated in another study in the past 12 months
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* The patient is in military service (unavailable for monitoring)
* Patient is on parole or otherwise has their liberty restricted by administrative or judiciary decision
* The patient is pregnant, or does not have contraception
* The patient is breastfeeding
* Patient has neoplastic disease
* Patient has asthma
* Patient has another, evolving pulmonary disease (tuberculosis, pulmonary interstitium disease, active or recent pulmonary infection)
* Patient has a clinical history indicating asthma or another respiratory disease (in particular bronchiectasis, pneumoconiosis and other occupational diseases, history of pulmonary neoplasia, HIV, immunosuppressive therapy including corticosteroids in the long term
* Patient has respiratory insufficiency
* Hypereosinophilic patient (the number of polynuclear eosinophils is \> 0.5 giga/l; confirmed on 2 hemograms)
* Recent psychiatric trouble (less than 1 year)
* Takes illegal drugs
* Patient does not have pneumological care according to the standards set by the French Language Pneumologist Society
Prenatal Pilates Assisted Childbirth Preparation Training and Incontinence

A randomized controlled trial was made to determine the effectiveness of prenatal pilates-supported childbirth preparation training on birth outcomes, incontinence during pregnancy, and the postpartum period.

One of the risk factors for the development of stress incontinence in women is pregnancy and childbirth. This problem increases as pregnancy progresses and continues in the postpartum period.

It was tested the hypothesis, there is no difference in the development of urinary incontinence in the prenatal and postpartum periods among women who receive Pilates-assisted childbirth preparation training and women who were into the usual care.

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18-35,
* Being in the 28th-30th week of pregnancy
* Having a singleton pregnancy
* Being nulliparous

Exclusion Criteria:

* Having chronic constipation
* Having a chronic cough
* Having a history of any psychiatric condition, multiple sclerosis, spinal cord injury, congenital or acquired anatomical abnormalities of the urogenital tract, bladder malignancy
* Being overweight and obese
* Giving birth outside of 37-42 weeks
A Nutrition Intervention to Lower Blood Pressure in Adolescents

The purpose of this study is to evaluate the efficacy of a 12-week, clinic-based, behavioral nutrition intervention emphasizing fruits, vegetables, and low fat dairy compared to routine nutrition care on changing diet quality and blood pressure post-treatment and at short-term follow-up in adolescents with hypertension.

Among youth, hypertension is no longer a rare disease, affecting about 7 million children and adolescents. Numbers are increasing with the evolving pediatric obesity epidemic in the US. More adolescents than children have primary hypertension, which tracks into adulthood and has been linked with preclinical indicators of adverse cardiovascular events in adults. Early prevention and intervention efforts are needed to address this increasing public and individual health problem. The purpose of this project is to evaluate the immediate and sustained impact of a 3-month clinic-based behavioral nutrition intervention emphasizing a diet high in fruits, vegetables, and low fat dairy, and low in fat and sodium (the DASH intervention) versus routine nutrition care on changing diet quality and blood pressure in adolescents with pre-hypertension or hypertension. The DASH intervention will include a printed participant manual, 1 individual counseling session with a dietitian, 4 mailings and 10 telephone calls on behavioral strategies to promote dietary change. Routine care will include 1 individual counseling session with a dietitian on dietary guidelines consistent with those of the National High Blood Pressure Education Program. Adolescents with prehypertension or hypertension will be randomly assigned to the DASH intervention or routine nutrition care after pre-treatment assessment. Post-treatment and at 3-month follow-up, outcome measures will be assessed including dietary intake and blood pressure. Our expectations are that the DASH intervention will significantly improve dietary quality and blood pressure in adolescents with elevated blood pressure compared to that observed as a result of routine nutrition care. The findings from this study are expected to improve the manner in which hypertension among adolescents is being treated in the clinical setting and contribute to the enhancement of the cardiovascular health of the target population.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of prehypertension or stage 1 hypertension
* age 11-18 years
* english speaking

Exclusion Criteria:

* stage 2 or secondary hypertension
* target organ damage or symptomatic hypertension
* type 1 or 2 diabetes
* treated with anti-hypertensive medications or other blood pressure altering medications
* are unwilling to stop use of vitamins, minerals or antacids containing calcium or magnesium
* do not have full medical clearance from a physician to participate
Study of the Safety, Tolerability, Pharmacokinetics and Biomarker of DONQ52 in Celiac Disease Patients

This study is to characterize the safety and tolerability of an investigational drug called DONQ52 and consists of a single ascending dose part (Part A) and a multiple ascending dose part (Part B) in well-controlled celiac disease patients.


Eligibility Criteria:
Inclusion Criteria:

* History of medically diagnosed celiac disease based on biopsies and positive celiac serology.
* Be on a GFD for at least 12 months
* HLA-DQ2.5 genotype
* Experienced at most mild symptoms of celiac disease

Exclusion Criteria:

* Refractory celiac disease
* Positive for any of the 3 serology (-Tissue transglutaminase-2,- Deamidated gliadin peptide-IgA, and deamidated gliadin peptide-IgG)
A Pilot Study of NSICU Assessment of Seizure Prophylaxis With Lacosamide

Trial to determine if seizure prophylaxis with IV LCM in NSICU patients experiencing mental status changes due to severe traumatic brain injury (sTBI) will result in improved short- and long-term outcomes and better immediate adverse effects when compared to the current standard of care anticonvulsant (IV fPHT) and will be at least as effective as IV fPHT in preventing clinical and sub-clinical seizure activity.

The goals are to compare IV LCM and IV fPHT for seizure prophylaxis in the neuro-critical care setting in terms of the following outcome measures:

1. The short- and long-term incidence of adverse events related to the anticonvulsant medication
2. The frequency of clinically-evident and sub-clinical seizures, as demonstrated by continuous EEG monitoring for the first three days and by clinical assessment for up to 6 months after initial admission.
3. Intermediate and long-term outcomes as measured by standard outcome measures including Extended Glasgow Outcome Scale, Disability Rating Scale, and Resource Utilization Questionnaire

Eligibility Criteria:
Inclusion Criteria:

* Subject with traumatic brain injury admitted to the hospital less than 24 hours prior to randomization
* GCS score 3-8 (inclusive) or GCS motor score of 5 or less and abnormal admission CT scan showing intracranial pathology
* Hemodynamically stable with a systolic BP \> 90 mmHg
* At least one reactive pupil
* Age at least 18 years
* Signed informed consent and HIPAA authorization for research form
* Patients will not be excluded because of race, gender, educational status or occupation

Exclusion Criteria:

* No venous access
* Spinal cord injury
* History of or CT confirmation of previous brain injury such as brain tumor, cerebral infarct, or spontaneous intracerebral hemorrhage
* Hemodynamically unstable
* Suspected anoxic events
* Other peripheral trauma likely to result in liver failure
* Age less than 18 years of age
* Known hypersensitivity to any anticonvulsant
* Any treatment, condition, or injury that contraindicates treatment with Lacosamide (LCM) or fos-phenytoin (fPHT)
* Inability to obtain signed informed consent or HIPAA authorization for research
Evaluation of Impact of Sandostatin® Injection Before Axillary Clearance on Lymphocele Formation

The lymphocele is the main early postoperative complication of axillary clearance for breast cancer patients with rates up to 85%.

The usual treatment consists of external drainage. However, this method increases the duration of hospitalization.

As a result, some practitioners have abandoned drainage, allowing for ambulatory surgery.

If this solution makes it possible to reduce the duration of the hospitalizations, it involves iterative punctures of the axillary hollow in case of lymphocele These punctures may be responsible for pain, hematoma or infection of the operative site.

To date, no method has proved superior in terms of decreasing the incidence of lymphocele postoperatively axillary clearance.

Octreotide (Sandostatin®) is a peptide, one of whose effects is to reduce the inflammation responsible for lymphoceles.

The aim of the study is to inject Sandostatin® before surgery, with the aim of reducing the incidence of seroma by 50% after axillary clearance


Eligibility Criteria:
Inclusion Criteria:

Breast cancer, histologically proven Axillary clearance Elective axillary approach Age ≥ 18 years OMS \< 3 Normal hematological and hepatic blood tests Obtaining the signed written consent of the patient

Exclusion Criteria:

Axillary clearance with a mastectomy Metastatic disease Disorder precluding understanding of trial information or informed consent Pregnancy, breastfeeding women Patient is willing and able to comply with the protocol for the duration of the study including all scheduled treatment, visits and examinations No severe or uncontrolled diabetes Known hypersensitivity to Octreotide Patient with vitamin B12 deficiency Anticoagulant treatment History of cardiovascular disease Other product being tested in the 4 weeks prior to the start of treatment Patient has valid health insurance
Dextromethorphan for the Treatment of Parkinson's Disease and Similar Conditions of the Nervous System

This study is designed to determine whether dextromethorphan, a drug commonly found in cough medicine, is beneficial and safe for the treatment of Parkinson's disease and other diseases that might share biochemical abnormalities with Parkinson's disease.

Patients with Parkinson's disease are missing the chemical neurotransmitter dopamine. This occurs as a result of destructive changes in an area of the brain responsible for making dopamine, the basal ganglia. Rhythmical muscular tremors, rigidity of movement, shuffling footsteps, droopy posture, and a mask-like expression on the face characterize Parkinson's disease.

Researchers believe that dextromethorphan may be able to safely modify psychomotor function of patients with Parkinson's Disease.

The ability of the putative excitatory amino acid receptor antagonist, dextromethorphan, to modify psychomotor function safely in patients with neurodegenerative disease will be evaluated using a modified double-blind placebo-controlled design. Therapeutic activity will be rated at various doses by means of standard motor and cognitive performance scales. Safety will be assessed at frequent intervals by clinical observation and laboratory tests.

Eligibility Criteria:
Parkinson's disease or other neurodegenerative disorders in which excessive stimulation of central glutamatergic pathways is hypothesized.

Patients must be in good general health and have no history or clinical evidence of significant cardiac (including dysrhythmias), pulmonary, gastrointestinal, renal, hepatic, endocrine, hematological or psychiatric disease.

Patient must not evidence any disorder which in the opinion of the investigator imposes an unnecessary risk to the patient or compromises the scientific interpretation of the data.

Individuals of child bearing potential must practice appropriate methods of birth control.
Palatal Mucosa Wound Healing Following Antimicrobial Gel Application

The present study will be a prospective, randomized, triple-blind, split-mouth, clinical trial.

The study timeline will be include seven total visits. After a screening/study enrolment visit, a wounding surgery visit (Day 0) will be schedule. On Day 0, one standardized wound will be created on each side of the palate (DFGG required for root coverage procedure). Each side of the palate randomly received either antimicrobial gel (treatment group) or placebo (control group) at day 0, 1 and 3.

The patients, an experienced periodontist who performed the surgical procedures and the clinical examiners will be blinded to treatment allocation.

Clinical healing response and patient related outcome measures (PROMs) will be evaluated on postoperative Day 1, 3, 7, 14, 21 and 30.


Eligibility Criteria:
Inclusion Criteria:

* aged 18 to 38 years (age limits based on evidence of delayed wound healing in older adults, Engeland et al., 2006);
* full-mouth plaque score and full-mouth bleeding score ≤ 15% at study entry;
* adequate anteroposterior arch length for required wound size and spacing;
* able to easily tolerate maxillary impression making and use of palatal template;
* patients required at least two root coverages procedures in one tooth in different sextants with DFGG;
* palate with no pathological or morphological alteration.

Exclusion Criteria:

* untreated periodontitis;
* previous surgery on the palate;
* history of poor wound healing;
* systemic diseases and/or coagulations disorders;
* pregnant or lactating;
* smoking or marijuana use (non-smoker status verified by exhaled air carbon monoxide as previously described);
* medications affecting periodontal status (e.g. phenytoin, calcium channel blockers and cyclosporine);
* therapy with anticoagulants, nonsteroidal anti-inflammatory drugs, corticosteroids, or any drug interfering with the healing process during the previous six months;
* contraindication to receiving any of the active components of the antimicrobial gel.
Timing for Bone Marrow Mononuclear Cells After Acute Myocardial Infarction

Most studies on intracoronary bone marrow mononuclear cell (BMC) transplantation for acute myocardial infarction (AMI) involve treatment 3-7 days after primary percutaneous coronary intervention (PCI); however, the optimal timing is unknown. The present study assessed the therapeutic effect at different times after ST-elevation myocardial infarction (STEMI).

On the basis of experimental studies that bone marrow mononuclear cells (BMCs) transfer in the injured tissue can promote regional myocardial perfusion and improved cardiac function, several clinical trials have shown that intracoronary bone marrow mononuclear cell (BMC) transplantation in acute myocardial infarction (AMI) patients several days after myocardial reperfusion is safe and may enhance the improvement of left ventricular ejection fraction (LVEF). The timing of BMC administration, baseline LVEF, dosage of BMC and other factors has been linked to improvement in LVEF after BMC transplantation. In our previous work, we gave BMCs within 24 hours after emergency percutaneous coronary intervention (PCI) and found that it was safe and effective . In addition, there are another report about longer time from symptom onset to BMC infusion (2-4 weeks), which also appeared effective . The timing of intracoronary stem cell administration may have a critical effect on cell engraftment and may be responsible for the various biological and functional responses to therapy. However, few studies have directly addressed the optimal timing of cell injections. Therefore, in this prospective randomized study, BMCs were given at different times (within 24 hours, 3 to 7 days, or 7 to 30 days after reperfusion) to investigate whether the timing of therapy affects the therapeutic response of AMI patients.

Eligibility Criteria:
Inclusion Criteria:

* a history of first acute ST-elevation myocardial infarction
* treatment with successful PCI two to twelve hours after symptom onset
* LVEF less than 50% on angiography immediately after emergency PCI or rescue PCI

Exclusion Criteria:

* previous Q-wave myocardial infarction
* cardiogenic shock
* severe coexisting conditions such as acute and chronic heart failure, malignant
* arrhythmia, renal failure and severe bleeding that interfered with the ability of the
* patient to comply with the protocol