cyrilzakka/clinical-trials huggingface dataset:
"Hub and Satellite" Heart Failure Provider's Network Study

The aim of this study is to serve as a pilot showing the feasibility of a "Hub and Satellite" Heart Failure (HF) Provider's Network which will aim to provide improved, evidence-based care to Veterans with HF. Primary Care Providers in the VA Community Based Outpatient Clinics (CBOCs) will undergo a brief period of intensive training in HF management and then practice in a network of primary care providers supported by the Regional HF Center.

Background:

Congestive heart failure (HF) is a major public health problem. There is a pressing need to improve treatment of HF, but lifesaving therapies remain underused in clinical practice. The investigators proposed a novel, potentially cost-effective model of community-based, multidisciplinary, collaborative HF care - the "Hub and Satellite" Heart Failure Providers Network. Primary care providers trained in HF management would provide improved care to their clinic patients with HF in "satellite" clinics, supported by the Regional HF Center "hub".

Objectives:

1. To establish and demonstrate the feasibility of the "Hub and Satellite" Heart Failure Providers Network
2. To obtain data examining clinical effectiveness and barriers

Methods:

Volunteer community-based primary care providers underwent 3 days of HF management training at the regional HF center (Nashville), consisting of 21 hours of lectures, briefings, teaching sessions and case presentations. Multiple choice testing and a survey interview were completed at the beginning and end of training. Exclusive access was given to the services of a clinical pharmacist to titrate HF medications to clinical guideline-recommended doses.

Providers received updates on advances in HF management. A confidential feedback report on their performance was given to HF providers. Formative evaluation was performed through pre-educational and 4 subsequent telephone interviews with HF providers.

Decision Support System (DSS) data was used to identify patients with systolic HF (ejection fraction\<40%) cared for by the HF providers; systolic HF patients in the same clinics cared for by non-HF trained providers were randomly selected as controls. Data on the care received over the one year period of follow-up was collected from DSS data and the computerized patient record system (CPRS).

Status:

One year of study follow-up has been completed. Primary data analysis is continuing. Work done to date has successfully demonstrated the feasibility of implementing a "Hub and Satellite" HF Providers network, including high provider satisfaction.

Eligibility Criteria:
Inclusion Criteria:

Healthcare providers (physicians, nurse practitioners, physician's assistants) who practice in a Community Based Outpatient Clinic (CBOC) in the Tennessee Valley Healthcare System, and are willing to undergo Heart Failure Training

Exclusion Criteria:

Community Based Outpatient Clinic (CBOC) Providers who are unable to attend the 3 day Heart Failure Training at the Regional Heart Failure Center.
Elaboration of a Pre-surgery Mapping Protocol of Primary Motor Cortex, Prior to an Implementation of a Stimulation of Primary Motor Cortex for Patients With Deafferentiation of Brachial Plexus Pain

In the context of an insufficiency of clinical results for cortical stimulation in treatment of brachial plexus post-avulsion pains, one of the possibility for failure is the bad pre-surgery mapping of the area to stimulated bu the usual methods (PEM et fMRI). This purpose of this study is to realise a precise mapping of the primary motor cortex post brachial plexus avulsion.

The principal endpoints is to identify and test the reliability of a muscular marker for which the cortical representation is localized immediately next to the superior member area. Several muscles of cephalic, cervical and chest area will be investigate.

The methods used will be mono-shock transcranial magnetic stimulation (mTMS) and functional MRI.

Concerning mTMS, several methods will be tested: best position on the scalp, realisation of outputs maps with extreme points average method, with mass center method.

Concerning fMRI studies, the above paradigms will be checked: imaginary movements of hand, blow up and down abdomen, eyes winking.

Statistical tests will confirm the best muscle candidate and will permit to evaluate the reliability of the method.


Eligibility Criteria:
Inclusion Criteria:

* For all groups: informed consent, social insurance
* For group 1 "painful BPA": consulting to the Nantes'UH for pain of BPA, EVA≥4, neurological deficiency partial or total
* For group 2 "painless BPA": EVA\<4, neurological deficiency partial or total, matching with group 1 on the neurological deficiency
* For group 3 "Healthy": matching with group 1 on age ±10 years

Exclusion Criteria:

* No informed consent
* Medical history of epilepsy
* Pregnant women
* Contra-indication to MRI
Single and Combined Effects of Behavioral, Academic, and Medication Treatments for ADHD in the Classroom

This study is the first to systematically evaluate the efficacy of single and combined academic accommodation, behavioral treatment, and medication treatment in a large sample of children with ADHD. Using a scientifically rigorous, cross-over design the impact of these approaches on ecologically valid measures of outcome (on-task behavior, quiz scores, academic productivity) will be assessed to inform effective school intervention.


Eligibility Criteria:
Inclusion Criteria:

* ADHD Diagnosis
* IQ \>= 70

Exclusion Criteria:

* Prior adverse reaction to methylphenidate
* Autism Spectrum disorder level 2/3
* Child is home schooled
Safety & Efficacy of Nicotinamide Riboside Supplementation for Improving Physiological Function in Middle-Aged and Older Adults

The purpose of this study is to assess the efficacy of supplementation with the Nicotinamide Adenine Dinucleotide (NAD+) precursor compound, Nicotinamide Riboside (NR), for improving physiological function (vascular, motor, and cognitive) in healthy middle-aged and older adults.

Overall, the proposed research project has the long-term potential to influence clinical practice by establishing novel therapies for treating multiple domains of age-associated physiological dysfunction and thereby reducing the risk of clinical disease and disability.

Eligibility Criteria:
Inclusion Criteria:

* Ability to provide informed consent
* Baseline brachial flow-mediated dilation (FMD) \< 6%Δ (rationale: non-invasive screening to ensure exclusion of subjects with exceptionally high baseline endothelial function.
* Ability to perform motor and cognitive tests (e.g., can rise from a chair, walk for 2 min, climb 10 stairs)
* Women will be confirmed as postmenopausal (either natural or surgical) based on cessation of menses for \>1 year.

Exclusion Criteria:

* ages \<55 years or ≥80 years
* body mass index (BMI) \>40 kg/m2 (rationale: vascular function and blood pressure measurements can be inaccurate in severely obese subjects and these subjects may differ in many ways from normal weight, overweight or less obese subjects)
* not weight stable in the prior 3 months (\>2 kg weight change) or unwilling to remain weight stable throughout study (rationale: recent weight change or weight loss can influence vascular function)
* having unstable angina, acute myocardial infarction, coronary angioplasty, or aorto-coronary bypass surgery as defined by the occurrence of an event, symptom, surgery, or change in medication and/or dosage within 3 months prior to enrollment
* having thyroid disease that is not controlled by medications or \<3 month's use of a particular medication and/or dosage (rationale: uncontrolled thyroid diseases are associated with alterations in vascular function)
* having past or present alcohol dependence or abuse, as defined by the American Psychiatry Association, Diagnostic and Statistical Manual of Mental Disorders
* abnormal blood chemistries for renal and liver function (\>1 standard deviation outside the normal range)
* Moderate or severe peripheral artery disease (ankle-brachial index \<0.7).
* Insufficient health to participate in a VO2max test based on a physical examination and/or graded exercise test (this will be determined in accordance with stated contraindications for exercise testing provided by the American Heart Association).
Telephone Support From Primary Care for Breastfeeding Mothers

The investigators will conduct a telephone-based support to breastfeeding women with healthy newborns to improve breastfeeding outcomes.

The World Health Organization recommends exclusive breastfeeding to infants until 6 months of age in order to achieve optimum growth. The proportion of exclusive breastfeeding mothers at 6 months is only 24.7 in Spain. The investigators believe it is important to increase the proportion of breastfeeding mothers in their population. Therefore, the investigators have developed a telephonic support protocol for mothers. The intervention will be performed by pediatric nurses in Primary Care.

The main aim of this study is to evaluate in a randomized controlled trial the effectiveness of telephone-based breastfeeding support in exclusive breastfeeding. The secondary aim is to evaluate the effectiveness of the telephonic support in any breastfeeding.

The investigators hypothesis is that this intervention will increase exclusive breastfeeding and any breastfeeding rates.

The study will be carried out in Cornellà, a semi-urban area near Barcelona. Participants will include breastfeeding women who have full-term healthy infants. Mothers will be recruited upon their first arrival to Primary Care from hospital. Eligible mothers who consent to participate will be randomized into either the intervention group or the control group. The latter will receive standard postpartum care. The former will receive standard postpartum care, plus a weekly telephone call during the first two months and every 2 weeks thereafter between the second and the sixth month. The pediatric nurse responsible for monitoring the standard care of each and every patient will be the one responsible for contacting them via telephone. Therefore, the study is not blinded.

The evolution of exclusive breastfeeding will be compared to artificial or supplemented feeding at 1, 2, 4 and 6 months. The effect of the intervention on breastfeeding supplemented with formula will also be valued. Classification into breastfeeding categories is based on 24-hour dietary recall.

Eligibility Criteria:
Inclusion Criteria:

* Mothers with healthy newborns
* 37 weeks gestation or greater
* Exclusive breastfeeding or any breastfeeding when arrive at Primary Care

Exclusion Criteria:

* Infant or mother admitted in ICU
* Twin pregnancy
* Major congenital malformation of babies
* Mothers age \<= 18
* Inability to understand Spanish/Catalan
* Mothers who don't have a telephone
* Mothers who don't give her consent
Domiciliary Versus Hospital Management of PPROM

This study is designed to compare efficacy \& safety of planned domiciliary versus hospital care for women with preterm prelabor rupture of the membranes (PPROM) on fetal, neonatal and maternal outcome.

Background: PPROM is encountered in 2.0% to 3.5% of pregnancies. Domiciliary care management is developing more and more in obstetrics, with psychological benefits for patients as well as other financial benefits. Reliable discharge criteria have been mentioned by few studies for patients with PPROM. Studies had shown that domiciliary care management in a context of PPROM did not modify perinatal morbidity and mortality, and allows a prolongation of the latency period. However, eligibility criteria for domiciliary care management were heterogeneous

Aim of The Work: The aim of this study is to compare efficacy \& safety of planned domiciliary versus hospital care for women with preterm prelabor rupture of the membranes (PPROM) on fetal, neonatal and maternal outcome.

Patients \& Methods: The current trial was conducted at Ain Shams University Maternity Hospital. A total of 3662 pregnant women were recruited from the outpatient clinic \& emergency room and included in the study. Then, they were randomized into two groups; group (D) was counseled for home care management, while group (H) was hospitalized. Take-home baby was assessed as a primary outcome and other maternal, fetal \& neonatal complications were recorded \& moreover latency period, mode of delivery \& preference of care were assessed

Eligibility Criteria:
Inclusion Criteria include women with PPROM ≥28 weeks \& \<37 weeks with no signs of intra-amniotic infection \& membranes rupture is confirmed by a sterile speculum examination and decrease amniotic fluid on ultrasound with singleton, viable, cephalic presenting fetus, morphologically normal fetus by ultrasound \& reactive fetal heart rate tracing with no evidence of meconium-stained liquor

Exclusion Criteria:

* Query PPROM: A history of PPROM with no pooling of amniotic fluid from the cervix on a sterile speculum examination
* Maternal comorbidities (Diabetes mellitus, hypertension, etc.)
* Patients with placenta previa
* Amniotic fluid pocket on ultrasound \< 2x2 cm
* Logistic problems interfering with follow-up
* Inability to check temperature every six hours, with parameters for notifying their clinician (temperature ≥38°C)
* Non-Dependable transportation
The Relationship Between Lipid Peroxidation Products From Traumatic Brain Injury and Secondary Coagulation Disorders

The purpose of this study is to observe the relationship between the level of lipid peroxidation products in serum of patients with traumatic brain injury and secondary coagulation disorders.

Uncontrolled hemorrhage after trauma is the leading cause of death. The mechanism of secondary coagulation dysfunction after trauma is special and complex, which has not been fully explained, leading to limited treatment and prevention methods. Coagulation disorders caused by traumatic brain injury is a systemic manifestation of local injury, which can activate platelets and promote platelet aggregation, activate thrombin, and promote the production of fibrin, leading to the formation of thrombosis. However, in non-injured areas, pro-coagulant molecules from damaged brain tissue reach the body through the broken blood-brain barrier, and also activate platelets and thrombin, promoting the formation of blood clots. Lipid peroxidation products are closely related to the occurrence of coagulation dysfunction. The effects lipid peroxidation products on platelets, thrombin and anticoagulant pathways may be a novel mechanism of secondary coagulation dysfunction in traumatic brain injury.

Eligibility Criteria:
Inclusion Criteria:

1. The interval between injury and admission is less than 24 hours
2. Age\>18yrs and age\<80yrs
3. Non-head abbreviated injury score \< 3
4. Did not undertake treatment before enrollment
5. Informed consent to participate in the study

Exclusion Criteria:

1. Take anticoagulants or antiplatelet drugs
2. Smoking history
3. Hemorrhagic or ischemic cerebrovascular disease occurred within six months
4. Other systemic diseases: uremia, cirrhosis, malignant tumor, etc
5. Patients with severe mental illness who are unable to communicate when diagnosed
6. Patients who refused follow-up
Effect of Different Plane Blocks on Quality of Recovery and Postoperative Pain After Laparoscopic Hysterectomy

The goal of this clinical trial is to evaluate in effect of tap block and esp block on quality of recovery and postoperative pain after laparoscopic hysterectomy. The main question it aims to answer are: Are these two plane blocks used superior to each other? Participants;

* will fill out the preoperative questionnaire
* will fill out the postoperative questionnaire
* will report their pain status according to the NRS score

Standard management of acute pain after surgery consists mainly of systemic opioid narcotics and nonsteroidal anti-inflammatory drugs (NSAIDs). Generally, opiates and NSAIDs are not completely effective at managing pain, and they carry significant risk of addiction and overdose, particularly with prolonged or increased dosing. The concept of multimodal or ''balanced'' analgesia is rapidly becoming the 'standard of care' for preventing post-operative pain. It consists of the use of combinations of analgesics of different classes with different sites of action in an attempt to provide superior pain relief with reduced analgesic related side effects. Local anesthetic injection to block specific nerves has been widely recognized as a useful adjunct in a multimodal approach to postoperative pain management.

Erector Spinae Plane (ESP) block is a recently described plane block designed to block the dorsal and ventral rami of the spinal nerves. And this block provides visceral and somatic pain block.

Transversus Abdominis plane (TAP) block involves the injection of LA between the transversus abdominis (TA) and internal oblique (IO) muscles.This interfascial plane contains the intercostal, subcostal, iliohypogastric, and ilioinguinal nerves. These nerves give sensation to the anterior and lateral abdominal wall as well as the parietal peritoneum, providing only somatic and not visceral analgesia.

Eligibility Criteria:
Inclusion Criteria:

* Female patients who will undergo hysterectomy under elective conditions
* 18- 65 years
* ASA I-II patients

Exclusion Criteria:

* Refusal during registration, request to be excluded from the study, failure to give informed consent
* Under 18 years old and upper 65 years old
* ASA III-IV patients
* Chronic opioid use
* Presence of infection at the injection site
* Renal failure / Liver failure
* Bupivacaine sensitivity
* Use of anticoagulants
* BMI \< 18,5 , BMI \>35
Enteric Oxalate Absorption Study in Unclassified Hyperoxaluria

The purpose of this study is to learn more about a condition called 'unclassified hyperoxaluria'. People with this condition have large amounts of oxalate in their urine, which can cause kidney stones and kidney failure. We do not know what causes the high level of oxalate in the urine. In this study, we will evaluate absorption of a test dose of oxalate taken orally by measuring the amount of the test dose that is eliminated in the urine. We will compare the results of affected patients to healthy volunteers.

Participants' oxalate intake and output will be monitored and assessed over a 24 hour period. Participants will ingest a prescribed oxalate dose and urine oxalate will be monitored for the 24 hour study period.

Eligibility Criteria:
Inclusion Criteria:

* Age equal to or greater than 4 years (patient must be able to void on request).
* Have good health.

Exclusion Criteria:

* Any prior history of renal disease, or hypertension
* ALL subjects (controls and affected patients) will be asked to discontinue any diuretics, calcium supplements, H2 blockers, proton pump inhibitors or gastrointestinal motility agents for approximately one week prior to initiation of the study.
* Subjects with GFR \< 50 cc/min will be excluded.
Efficacy and Safety of Insulin Rinsulin® NPH Compared to Humulin® NPH in Type 2 Diabetes Mellitus Patients

The study is designed to approve non-inferior efficacy and safety of Rinsulin® NPH compared to Humulin® NPH.


Eligibility Criteria:
Inclusion Criteria:

* Signed written consent
* Diabetes mellitus type 2
* Indications for Rinsulin NPH / Humalog NPH treatment
* Glycosylated hemoglobin (HbA1c) level of 6.5 to 12.0 % at screening (both values inclusive)
* Body mass index (BMI) of 18.0 to 35 kg/m2 at screening (both values inclusive).
* Female patients of childbearing potential who are willing to use two acceptable methods of contraception, (e.g., intra-uterine device plus condom, spermicidal gel plus condom, diaphragm plus condom, etc.), from the time of screening and for the duration of the trial, through trial completion.

Exclusion Criteria:

* Age less than 18 years old at screening
* Pregnant and breast-feeding women
* Need of administration of glucocorticoid therapy or any other therapy that may influence glucose level
* Administration of any immunosupressive drugs (Cyclosporinum, Methotrexatum)
* Serological evidence of human immunodeficiency virus (HIV), hepatitis B (HbSAg), hepatitis C (HCVAb) or antibodies to Treponema pallidum (syphilis) at screening.
* History of hypersensitivity to any of the active or inactive ingredients of the insulin/insulin analogue preparations used in the trial, OR history of significant allergic drug reactions.
* History of hematological disorders that can affect the reliability of HbA1c estimation (hemoglobinopathies, hemolytic anemia, etc.).
* History or presence of a medical condition or disease that in the investigator's opinion would embarrass glycemic control and completion of the study
* Presence of severe diabetes complications
* Receipt of another investigational drug in the 3 months prior to screening
* Acute psychiatric disorder or exacerbation of chronic psychiatric disorder at screening
* History or presence of drug abuse
* Positive test for addictive substance in urine at screening
Optimal Multimodal Analgesia in Laparoscopic Cholecystectomy

To test the current standard of care (SOC) treatment for laparoscopic cholecystectomy with a group receiving SOC + additional perioperative analgesics in terms of postoperative abilities, PONV, pain and discharge time from the PACU

Aim of the study: to compare postoperative complaints (PONV, pain, etc) and PACU discharge time between two groups:

* A: standard of care (SOC)receiving intraoperative dexamethasone, ondansetron, ketorolac, and general anaesthesia with propofol, remifentanil and cisatracurium
* B: SOC + preoperative gabapentin, intraoperative lidocain infusion, s-ketamin and droperidol.

Primary endpoints:

* postoperative abilities over time
* discharge time from PACU according to fixed criteria
* consumption of analgesics and antiemetics in the PACU

Secondary endpoints:

* degree of nursing requirements at the PACU
* General tolerability of the regimes

Eligibility Criteria:
Inclusion Criteria:

* Elective laparoscopic cholecystectomy
* Age above 18 years
* Written informed consent
* ASA class I-III

Exclusion Criteria:

* Planned abdominal cholecystectomy
* Intraoperative conversion of laparoscopic to laparotomic cholecystectomy
* Allergy to part of the treatment regimens
* Previous reactions to opioids (nausea, cognition)
Meditoxin® Treatment in Patients With Post Stroke Upper Limb Spasticity

Botulinum Toxin for the Treatment of Post Stroke Upper Limb Spasticity.

This study is "A Multicenter, Prospective, Randomized, Evaluator Blinded, Comparing Phase 4 Study to Evaluate the Impact of Injection Techniques on the Effectiveness of Botulinum Toxin for the Treatment of Post Stroke Upper Limb Spasticity".

Eligibility Criteria:
Inclusion Criteria:

1. Male or female subject aged over 20.
2. Subjects who has grade 1 + and more spasticity at least one of upper limb muscles as measured on Modified Ashworth Scale after stroke.
3. Subjects who was diagnosed stroke at least 1 month prior to study participation.
4. Subjects or legal representatives who voluntarily decided the participation of the study and signed the informed consent.

Exclusion Criteria:

1. Subjects who had spinal injuries to be a factor of spasticity except for stroke prior to study enrollment.
2. Subjects with allergy or hypersensitivity to the Botulinum Toxin.
3. Subjects who have changed the muscle relaxant taking for treatment within past 4 weeks prior to study participation.
4. Subjects who have taken injection treatments using alcohol or phenol in upper limb within past 6 months prior to study participation.
5. Subjects with general neuromuscular synaptic disorder(e.g. Myasthenia gravis, Lambert-Eaton syndrome, Amyotrophic lateral sclerosis).
6. Subjects who have been injected with botulinum toxin within past 3 months before the injection.
7. Subjects who are pregnant or lactating of disagreed to avoid pregnancy during 3 months study period.
8. Subjects who are scheduled to take part in other clinical trial during the study period.
9. Patients who are not eligible for this study at the medical discretion of the investigator.