cyrilzakka/clinical-trials huggingface dataset:
Comprehensive-Care for Multimorbid Adults Effectiveness Study

This study is intended to examine whether directed care of a nurse working jointly with the patient's primary care physician, including a comprehensive assessment, creation of a tailored care plan, proactive follow-up, self management support and caregiver support and care coordination, can reduce hospital admissions for patients with multiple chronic conditions.

Patients with multi-morbidities pose a significant challenge for healthcare organizations because they require continuity of care among a wide range of long-term therapeutic paradigms for many different types of diseases. The current study is based on a treatment model entailing a nurse-primary care physician team to provide care for patients with multiple morbidities.

Patients in the intervention group who agreed and signed the consent form to participate in the study will receive treatment by the physician - nurse team in accordance with the components of the Clalit's Comprehensive Care for Mutlimorbid Adults Project model. Components of the intervention include:

1. Comprehensive assessment of the patient's and family's needs
2. Coordinated care plan based on integrated care guides
3. "Multimorbid Action Plan" for patients
4. All-inclussive patient centered care and caregiver support
5. Proactive monitoring according to the plan.

Patients in the control groups will receive usual care in their primary care clinics. The Usual Care Survey control group will complete study questionnaires at 6, 12 and 24 months after enrollement.

The Usual Care Blinded group will be assessed only retrospectively based on deidentified information from Clalit's admistrative databases.

Eligibility Criteria:
Inclusion Criteria:

* ACG system high risk probabilty score - 4% Highest Risk Score
* Age 18 and older
* 2 or more chronic conditions

Exclusion Criteria:

* Patients already included in a controlled disease management program (e.g., COPD disease management and telehealth).
* Participation in any medical research.
* Confined to bed.
* Inpatient nursing care, nursing homes.
* Kidney, liver or heart transplant patients.
* Active (receipt of oncology chemotherapy , radiotherapy or other oncology treatment during the past 3 years).
* Dialysis patients.
* Clalit Healthcare Services employees.
* Patients with major active mental illness, such as schizophrenia.
* Cognitive failure.
* Non Hebrew speaking patients without Hebrew speaking primary informal caregiver.
* Bedridden patients
* Housebound patients
Clinical and Biomechanics Research in Core Muscles After Lumbar Fusion Surgery

Lumbar fusion has been widely used for spinal disorders when conservative treatment has failed. However, a number of studies have reported that the rate of re-operation is high for lumbar fusion surgery. Swelling, atrophy or fat infiltration of the paraspinal muscles at the surgery site can cause weakness and pain. After fusion, the range of motion is constrained at the fused spine and might facilitate compensative movement of the adjacent levels and increase degeneration rate of the spine.

Evidence has shown that core muscles play an important role to stabilize and support the spine. Whether core stability exercise can enhance spinal stability after lumbar fusion surgery remains unclear. Therefore, the overall goal of this proposed research is to investigate how core muscles affect outcomes after lumbar spinal fusion. The investigators will explore this issue hierarchically and systematically in 3-year duration.


Eligibility Criteria:
Inclusion Criteria:

1. ages between 20 and 85 years,
2. back pain and/or sciatica exceeding 12 weeks for which conservative treatment had failed to improve,
3. a primary diagnosis of spinal stenosis, spondylosis, degenerative or isthmic spondylolisthesis or degenerative disc disease, and
4. the patient selected for lumbar surgery

Exclusion Criteria:

1. mechanical back pain due to posture changes and cannot maintain an upright posture over 30 minutes;
2. segmental instability that includes isthmic spondylolisthesis, degenerative spondylolisthesis over 0.4 cm;
3. intervertebral angle reversal on dynamic radiographs; and
4. previous lumbar fusion, rheumatoid arthritis, and ankylosing spondylitis.
Detection of Human Cytomegalovirus in the Saliva

Direct DNA amplification, viral isolation and specific antibody measurement in saliva

1. From children in day care centers (samples collection will take place during a single week)
2. From children coming at the emergency department of our hospital during a three months period.

Sample collection will be done by the pediatrician the nurse, or one of the authorized investigators of the study.

Salivary collection kit. Collection of salivary at the internal face of the mooth. 3 swab for DNA research, 1 for antibodies research and 1 for virus isolation by cell growth.

Eligibility Criteria:
Inclusion Criteria:

* parents consent
* child aged from 3months to 6 years
* child in day care centers or emergency department

Exclusion Criteria:

* Refuse of participation
A Study to Assess the Relative Bioavailability of Three Immediate-Release Tablet Formulations of ABBV-903 in Healthy Adult Volunteers

The purpose of this study is to evaluate the relative bioavailability of three immediate-release table formulations of ABBV-903 under fasting conditions in healthy volunteers, and to evaluate the effect of food on the pharmacokinetics of three immediate-release table formulations of ABBV-903.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) is \>= 18.0 to \<= 32.0 kg/m2 after rounding to the tenths decimal, at screening and upon initial confinement.
* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG).

Exclusion Criteria:

* History of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study drug.
* History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), endocrine, renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
The Effect of Group-based Lifestyle Medicine Intervention and CBT on Depressive Symptoms

The objective of this randomized controlled trial is to evaluate and compare the efficacy of group-based lifestyle medicine intervention and cognitive-behavioral therapy for depression (CBT-D) for Chinese adults with depressive symptoms.

Prior to all study procedures, eligible participants will be required to complete an online informed consent (with telephone support). Around 40 eligible participants aged between 18 to 65 with depression (Patient Health Questionnaire-9 \[PHQ-9\] ≥ 10) will be randomly assigned to the Lifestyle Medicine group (LM group), or the CBT-D group in a ratio of 1:1. Participants in both groups will receive interventions either through lifestyle medicine intervention or CBT-D group therapy for 6 consecutive weeks. The outcomes of interest will include depressive, anxiety, and insomnia symptoms, quality of life, functional impairment, and health-promoting behaviours at baseline (week 0), immediate (week 7) and 3-month post-intervention assessments (week 19). Treatment credibility and acceptability will be collected before and immediately after treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Chinese adults reside in Hong Kong;
2. Aged between 18 to 65 years;
3. Have a Patient Health Questionnaire-9 (PHQ-9) score ≥ 10, indicating at least moderate level of depressive symptoms;
4. Able to read and understand Chinese/Cantonese and are fluent in Cantonese;
5. Willing to provide informed consent and comply with the trial protocol.

Exclusion Criteria:

1. Received psychotherapy for depression in the past 6 months;
2. A change in psychotropic drugs that target depression within 2 weeks before the baseline assessment;
3. A PHQ-9 question 9 score higher than 2, indicating a moderate level of suicidal risk that requires active crisis management (referral information to professional mental health services will be provided);
4. Currently participating in another intervention study that may potentially improve mental health;
5. Self-disclosure of any psychiatric, medical or neurocognitive disorder(s) that makes participation unsuitable based on the team's clinical experience or interferes with adherence to the lifestyle modification (e.g., where exercise is not recommended by physicians);
6. Pregnancy;
7. Hospitalization.
Pharmacokinetics of Single Bolus Dose of NovoSeven® in Paediatric and Adult Patients With Haemophilia A or B in a Non- Bleeding State

This trial is conducted in Europe. The aim of this trial is to determine the pharmacokinetics of activated recombinant human factor VII (NovoSeven®) in haemophiliac patients in a non-bleeding state.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-55 years and congenital haemophilia A or B male with severe FVIII or FX deficiency +/-inhibitors
* Age between 3-12 years and congenital haemophilia A or B male with record of inhibitors

Exclusion Criteria:

* Known hypersensitivity to activated recombinant human factor VII or any of its components
* Known clinical relevant coagulation diseases or insufficiencies other than congenital haemophilia
* Clinical manifestation of HIV (human immunodeficiency virus) and/or protease inhibitor treatment
* Clinical manifestation of active/recent bleeding
* Administration of coagulation factor preparations within 24 hours of NovoSeven trial product dose administration
* Body Mass Index (BMI) outside normal range
* Known abuse of elicit drugs and/or alcohol
* Renal insufficiency
* Hepatic disease
* Cardiovascular disease
* Any disease or condition which, judged by the Investigator, could imply a potential hazard to the patient, interfere with the trial participation or trial outcome
Aloe Vera in Irritable Bowel Syndrome

The purpose of the present study is to study the effect of aloe vera in the treatment of IBS patients in a randomized, double-blind placebo controlled study.

There is limited knowledge of the IBS pathophysiology, absence of biological markers and therefore few effective treatment options. IBS therefore contributes to difficulties in the management of the patients. Aloe vera has a long association with herbal medicine, from the Ebers Papyrus from 16th century BCE. It is alleged to be effective in treatment of wounds, to improve blood glucose levels in diabetics, and it may reduce symptoms and inflammation in patients with ulcerative colitis. Evidence of the effects of aloe vera in the treatment of IBS, is however limited and contradictory.

Eligibility Criteria:
Inclusion Criteria:

* IBS according to the Rome III criteria
* Adults

Exclusion Criteria:

* other GI disorders
* other medical conditions
* were pregnancy or breast-feeding
* food allergy or intolerance to other than lactose
* ongoing intake of aloe vera products
Ginseng in Treatment of Fatigue in Multiple Sclerosis

The purpose of this study was to evaluate the efficacy and safety of Ginseng in treatment of fatigue and Quality of Life of MS patients.

Multiple Sclerosis (MS) is one of the most common non-traumatic causes of disability in the world. It is a chronic inflammatory and demyelinating disorder of the Central Nervous System (CNS) which affects individuals in the productive ages and causes a large burden for years to come. Fatigue is a common complaint and one of the least understood symptoms of MS

Eligibility Criteria:
Inclusion Criteria:

* definite diagnosis of relapsing-remitting MS (RRMS) by the MacDonald criteria with a baseline of Expanded Disability Status Score (EDSS)of less than 5.0

Exclusion Criteria:

* prior use of ginseng or any other tonic agents, glucocorticoids, warfarin, digoxin, aspirin, furosemide, caffeine, ephedra and anti-platelet agents within one month prior to enrollment;
* Pregnancy or lactation;
* history of renal failure; and,
* lack of appropriate adherence to the study protocol.
Mifepristone Versus Laminaria for Cervical Ripening in Midtrimester Induction

Data from other countries have suggested that oral mifepristone used as a cervical ripening agent may decrease induction to delivery time in midtrimester inductions. To our knowledge, there are no trials comparing mifepristone to laminaria in a standard clinical setting with standardized misoprostol induction protocol to examine the issue of induction to delivery time. We hypothesize that mifepristone will work at least as well as laminaria for midtrimester cervical ripening prior to induction of labor with misoprostol.


Eligibility Criteria:
Inclusion Criteria:

* pregnant women with fetal anomalies, aneuploidy, or demise at 15-22 weeks gestation
* age greater than 16
* able to speak English

Exclusion Criteria:

* prior uterine scar or
* allergy or history of bad reaction to any of the study drugs or
* history of chronic adrenal failure or
* porphyria or
* concurrent long-term corticosteroid treatment
Isotretinoin Plus Dexamethasone in Treating Patients With Multiple Myeloma

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with dexamethasone may be an effective treatment for multiple myeloma.

PURPOSE: Phase II trial to study the effectiveness of combining isotretinoin and dexamethasone in treating patients who have multiple myeloma.

OBJECTIVES: I. Determine the response rate and duration of response of patients with multiple myeloma treated with dexamethasone and isotretinoin. II. Determine the toxicity of this regimen in these patients. III. Correlate the changes in serum interleukin (IL)-6, IL-6R, and C-reactive and IL-6R expression on plasma cells in the bone marrow with response in patients treated with this regimen.

OUTLINE: Patients receive oral dexamethasone on days 1-4, 9-12, and 17-20 and oral isotretinoin daily. Treatment repeats every 5 weeks for at least 2 courses in the absence of disease progression, insufficient response, or unacceptable toxicity. Patients achieving adequate response continue treatment for 2 courses after achieving a plateau of monoclonal protein, for a minimum of 6 courses total.

PROJECTED ACCRUAL: A total of 18-36 patients will be accrued for this study within 3 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed multiple myeloma Elevated monoclonal protein in serum and/or urine

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3\* Platelet count at least 75,000/mm3\* \*Unless secondary to multiple myeloma involvement of the bone marrow Hepatic: Bilirubin less than 1.5 mg/dL Transaminase less than 2 times normal Renal: Creatinine less than 2.0 mg/dL No overt renal insufficiency Cardiovascular: No congestive heart failure No myocardial infarction within the past 6 months No significant arrhythmia or poorly controlled hypertension Pulmonary: No severe pulmonary disease Other: Triglycerides normal No other severe medical illness No active peptic ulcer disease No brittle insulin-dependent diabetes No severe depression or other psychiatric illness No active infection No history of severe ethanol or drug abuse Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: Prior palliative radiotherapy allowed Surgery: At least 3 weeks since prior major surgery
Muscle Oxygenation in Effort in Neuromuscular Diseases

Previous studies showed modifications of muscle oxygenation parameters in muscular dystrophies du to an impairment or an absence of dystrophin.

Our study aim at assessing muscle oxygenation during effort in different neuromuscular diseases (muscular dystrophies related and not related to dystrophin, non dystrophic myopathies and motor neuron diseases) compared to a group of healthy controls. Patients and controls are invited to perform an inframaximal , standardized effort of the knee extensors by the mean of an isokinetic dynamometer. Muscle oxygenation parameters are assessed through a Near Infrared Spectroscopy (NIRS) Device.

In patients affected by dystrophin related myopathies, a muscle biopsy will be performed in order to analyse mitochondrial oxygenation parameters and mitochondrial phenotype.

Our Hypothesis is that muscle oxygenation is impaired in dystrophin related muscular dystrophies compared to other neuromuscular diseases and healthy controls because of lack of muscle capillary vessels dilatation during effort and impairment of mitochondrial function.

This study is a prospective physiological study in a pathological condition (neuromuscular diseases).

5 groups of voluntary participants will be investigated:

1. 20 subjects affected by Dystrophin related muscular dystrophy (Becker Muscular Dystrophy ) 2. Subjects affected by muscular dystrophy not related to dystrophin impairment : 20 subjects affected by facioscapulohumeral dystrophy and 20 subjects affected by Limb Girdle Muscular dystrophy 3. 20 subjects affected by non-dystrophic myopathies (Congenital myopathies ) 4. 20 subjects affected by motor diseases: amyotrophic lateral sclerosis(ALS), Charcot Marie Tooth disease, Spinal Muscular Atrophy .

5. 20 healthy controls Objective: asses the muscular oxygenation modifications during a standardized effort and compare the variables between groups. Analyze the mitochondrial function and phenotype in the BMD group compared to healthy controls Outcome : Muscle Oxygenation by Near Infrared Spectroscopy parameters; oxygen consumption, Muscle Function Measure, Vignos and Brooke score, Borg scale, 6 minutes walk test, mitochondrial phenotype, mitochondrial oxygenation 3 visits : 1- inclusion 2- standardized effort protocol 3- for Becker dystrophy patients and voluntary controls, muscle biopsy of the Vastus Lateralis

Eligibility Criteria:
Inclusion Criteria:

* healthy subjects and
* subjects affected by one of the fallowing neuromuscular diseases: Becker Muscular dystrophy Facioscapulohumeral dystrophy, Limb Girdle Muscular Dystrophy , Congenital Myopathy , Spinal Muscular Atrophy Charcot Marie Tooth Disease and Amyotrophic Lateral Sclerosis ,
* able to walk
* presenting a manual muscle testing of at Least 4/5 on the quadriceps according to the Medical research Council

Exclusion Criteria:

* musculoskeletal pain of the quadriceps
* other neurological disorders
* Heart failure arrhythmia, uncontrolled hypertension, angina pectoris
* dyspnoea \>2 according to the NYHA
* Peripheral artery disease
* BMI \>30kg.m-2.
Safety of Celecoxib in Patients With Crohn's Disease

The investigators will select 60 people who are 18-70 years of age with Crohn's disease and randomly assign them to receive an 8-week trial of celecoxib and an 8-week trial of a placebo. There will be a 1-week interval or "wash-out" between trials when the participant does not take any study medication. The investigators will monitor the participants for 18 weeks after they start the medication and observe their Crohn's disease activity, assessing for flare-ups or exacerbations in the disease and other possible side effects of celecoxib. Based on these observations, a determination will be made by the investigators as to the safety of celecoxib. If celecoxib is found to be safe, then it may provide physicians with a medication that they can prescribe for people who have Crohn's disease and experience chronic pain from arthritis and arthralgia.

Please refer to brief summary (above).

Eligibility Criteria:
Inclusion Criteria:

1. Greater than 18 years of age or less than 70 years of age
2. Confirmed diagnosis of Crohn's disease
3. Inactive disease (CDAI scores at baseline \<150) or active disease (CDAI scores at baseline \<200).

Exclusion Criteria:

1. Pregnant, nursing mothers and women of childbearing potential who are not using reliable contraception (i.e.: oral contraceptive pill \[OCP\], intrauterine device \[IUD\], Norplant)
2. Enrolled in any other study involving non-steroidal anti-inflammatory drug (NSAID) medications
3. NSAID use at time of study
4. Baseline moderate to severe Crohn's disease activity (CDAI \> 200)
5. Current treatment of less than 6 months with mercaptopurine (6 MP) or immuran.
6. Treatment with current Crohn's medication for a period of less than 3 months
7. Surgery for Crohn's disease (within 1 month)
8. Known sensitivity to celecoxib, NSAIDs, or sulfonamides
9. History of gastritis, gastrointestinal bleeding, or peptic ulcer disease
10. Advanced kidney disease
11. Severe hepatic impairment
12. Subjects currently taking angiotensin-converting enzyme (ACE) inhibitors, furosemide, fluconazole, lithium, corticosteroids, and warfarin
Anticoagulation-free VV ECMO for Acute Respiratory Failure

Currently international experts recommend therapeutic anticoagulation for veno-venous extracorporeal membrane oxygenation (VV-ECMO). Reports and case series suggest that the absence of therapeutic anticoagulation is safe for VV-ECMO. No randomized control trials have assessed this. The aim of this pilot study is to assess safety and feasibility of an "anticoagulation-free strategy" for veno-venous ECMO (VV-ECMO) in Acute respiratory distress syndrome (ARDS).

Although anticoagulation targets and monitoring strategies vary around the world, the current practice is still to anticoagulate patients on ECMO, mostly with UFH. However, the use of heparin coated circuits has changed their thrombogenicity. Preliminary data suggest that a low-dose unfractionated heparin (UFH) strategy is non-inferior to a therapeutic dose UFH. Indeed, in daily practice, when a patient on ECMO has severe bleeding complications, UFH is often stopped until the hemorrhagic issue is under control, sometimes for days. This has led some to hypothesize that anticoagulation might not be necessary for VV-ECMO, and a few case series report little to no increase in adverse events as a result. There are currently no randomized controlled trials comparing anticoagulation to no anticoagulation for patients supported with ECMO. Anticoagulation is, for physiological reasons, less necessary during VV-ECMO than VA-ECMO and this is the reason why our pilot study will focus on VV-ECMO only. Whereas the whole ECMO device is identical for both configurations, the risk of systemic embolization (e.g., stroke) and its severe complications is much higher in VA-ECMO where blood is reinjected directly into the systemic arterial system. Moreover, in the presence of severely decreased left ventricular function requiring VA-ECMO, the risk of left ventricular thrombus is very high and requires anticoagulation. During VV-ECMO, the risk of systemic embolization is low because the whole circuit is on the right side of the heart and relatively preserved biventricular function is needed to perform VV-ECMO

The hypothesis is that VV-ECMO is safe and feasible without therapeutic anticoagulation for adults with ARDS.

The objectives of this study is to assess, through a pilot study, the safety and feasibility of an "anticoagulation free strategy" for veno-venous ECMO (VV-ECMO) in acute respiratory failure

Eligibility Criteria:
Inclusion Criteria:

* Adult patient with ARDS on VV-ECMO

Exclusion Criteria:

* Contraindication to anticoagulation with UFH (known heparin-induced thrombocytopenia, active hemorrhage, any surgery precluding the use of anticoagulation),
* Indication for therapeutic anticoagulation (pulmonary embolism or deep vein thrombosis, chronic anticoagulation therapy before ECMO insertion)
* Low-flow (\<2 liters/min) VV-ECMO (ECCO2R)