cyrilzakka/clinical-trials huggingface dataset:
Use of ThermaCare Heat Wraps and Ibuprofen as an Adjunct to Physical Therapy for Neck Pain

Objective- To see if the use of heat at home between physical therapy sessions results in better therapy outcomes in people with acute neck pain.

Setting: Physical Therapy outpatient rehabilitation center Participants: 90 people with acute nonspecific neck pain broken into 4 groups. Intervention: All subjects will undergo 45 minutes of therapy 2 times per week for 2 weeks. All subjects will accomplish 1 hour of therapeutic exercise at home on days when there is no therapy. Thirty of the subjects will use ThermaCare neck wraps before home exercise, 30 used Ibuprofen plus ThermaCare neck wraps before home exercise, 15 will use a sham heat wrap and an Ibuprofen placebo each day (1200 mg / day) and the last 15 will be controls with conventional physical therapy.

Neck pain patients admitted to an outpatient physical therapy program will be randomly assigned to either a control or 3 experimental groups. An initial evaluation and rehabilitation program will be established which includes a home exercise program. Therapy will be 2 days per week for 2 weeks. Thirty of the subjects will use ThermaCare continuous heat neck wraps applied for 6 hours before home exercise, 30 will use ibuprofen (1200 mg /day given in 3 dosages) plus ThermaCare neck wraps before home exercise, 15 will use a sham heat wrap and a Ibuprofen placebo each day and the last 15 will have conventional therapy. Intervention with heat or Ibuprofen will be used on days that they are not being treated in the clinic. All groups will be evaluated initially and after 2 weeks. They will be given home exercise and heat compliance logs and analog visual pain scales to be filled out each night before exercise and, if they used heat, before and after heat will be applied. The physical therapist will also be asked to evaluate their home compliance, pain and the benefit to them from the heat packs. Subjects will complete a neck disability questionnaire at the beginning and end of the study. At the end of the two weeks of treatment, a multivariate ANOVA will be performed to compare changes in home exercise compliance, functional level, pain level, range of motion, and strength. A statistical level of p≤.05 is considered predictive of a difference between groups.

Eligibility Criteria:
Inclusion Criteria:

* age 18-80 years

Exclusion Criteria:

* those with neck pain caused by fractures or spinal damage
* those who have undergone neck surgery within the last year
* those with radiculopathy or those with diagnosed diabetes were excluded from this study
Multi-Center Study of Clinical and Inflammatory Outcomes in Intensive Cardiac Rehabilitation and Traditional Cardiac Rehabilitation Programs

The goal of this prospective study is to evaluate whether the Intensive Cardiac Rehabilitation (ICR) program provides incremental benefits over the Traditional Cardiac Rehabilitation (TCR) program, defined by readmission costs. The study aims to confirm:

* That ICR is associated with better outcomes than TCR, defined as lower readmission costs, lower incidence of major adverse cardiovascular events (MACE), and improvement in biomarkers, epigenetic markers, and inflammatory markers.
* The addition of food to the ICR program will further improve these outcomes.

ICR-eligible participants

* Will be randomized into one of three groups: (1) ICR 72 session program with home-delivered C2life® supplied food, (2) ICR 72 session without C2life® supplied food, or (3) TCR 36 session program without C2life supplied food
* Biometric measurements and laboratory measurements will be performed at entry into the rehab intervention, discharge from rehab intervention, and at 6 months after discharge.
* Epigenetic measurements will be performed at admission and discharge from the rehab intervention


Eligibility Criteria:
Inclusion Criteria:

* All patients eligible for an Intensive Cardiac Rehabilitation (ICR) Program at each of the three study sites outline below, stratified by one of the following qualifying cardiovascular events, including myocardial infarction (STEMI and NSTEMI), angioplasty and stents, coronary artery bypass, surgical or percutaneous valve repair or replacement, and stable congestive heart failure with reduced ejection fraction of 35% or less.

Exclusion Criteria:

* Anticipated life expectancy of under 2 years
* Any co-morbidity that would limit participation in the study.
Intake of Omega 3 in Morbidly Obese Patients

Ingestion of capsules of omega 3 EPA and DHA, with 1.8 g of EPA and 1.2 g DHA for morbidly obese patients, will improve the inflammatory status? C-reactive protein? Weight?

Intake of EPA and DHA for the management of morbid obesity in capsules

- Reduction of inflammatory factors such as adipokines, glucose, C-reactive protein, cholesterol, weight, BMI. Will be 2 groups: cases and controls. The cases will intake of omega 3 capsules and placebo control.

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged between 18-65 years,
* BMI \> 40 kg/m2 (or \> 35 kg/m2 with comorbidities),
* ambulatory, receiving an oral diet,
* with a diagnosis of metabolic syndrome,
* and who signed a Term of Free and Informed Consent.

Exclusion Criteria:

* Systemic inflammatory response syndrome,
* coma or compromised organ,
* fever or infection foci,
* cancer with or without chemotherapy and radiotherapy,
* radiotherapy, inflammatory diseases of the gastrointestinal tract,
* transplant, trauma, surgery or hospital stay in the past 30 days
* use of steroids or non-steroid anti-inflammatory or immunomodulators agents or antibiotics,
* or those refusing to take part in the study.
A Trial to Evaluate the Pharmacokinetic and Pharmacodynamic Properties of BioChaperone® Insulin Lispro, Fiasp® and NovoRapid® Delivered by an Insulin Pump

This is a single-centre, randomised, double-blind, three-period, complete cross-over trial comparing the pharmacokinetic and the pharmacodynamic properties of BioChaperone® insulin lispro and the two active comparators Fiasp® and Novorapid® when given as a bolus on top of basal delivery with an insulin pump in subjects with type 1 diabetes mellitus. Each subject will be randomly assigned to a treatment sequence consisting of 3 dosing visits during which the subject will receive the investigational products. In a euglycaemic clamp setting, subjects will be given a bolus dose of 0.15 U/kg body weight.

Throughout the glucose clamp procedure, blood glucose will be stabilised at a target level of 100 mg/dL by means of an intravenous infusion of glucose. Blood samples for pharmacokinetic assessment will be drawn at specified timepoints and glucose infusion rates and blood glucose concentrations will be recorded for pharmacodynamic assessment during the 10-hour clamp procedure after dosing.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 Diabetes Mellitus for more than 12 months.
* BMI between 18.5 and 28.5 kg/m².
* HbA1C level \<=9.0%.
* Insulin treated for at least 12 months with total insulin dose \<1.2U/kg/day.

Exclusion Criteria:

* Type 2 Diabetes Mellitus.
* History of multiple and/or severe allergies to drugs or foods.
* Any history or presence of clinically relevant cardiovascular, pulmonary, respiratory, gastrointestinal, hepatic, renal, metabolic, endocrinological (with the exception of conditions associated with diabetes mellitus), haematological, dermatological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynaecologic (if female), or infectious disease, or signs of acute illness as judged by the Investigator.
* More than one episode of severe hypoglycaemia with seizure, coma or requiring assistance of another person during the past 6 months.
* Proliferative retinopathy or maculopathy and/or severe neuropathy, in particular autonomic neuropathy.
* Females of childbearing potential, who are pregnant, breast-feeding or intend to become pregnant or are not using highly effective contraceptive methods.
HOST - DAPT Duration According the Bleeding Risk

* Dual antiplatelet agent therapy (DAPT) is essential in treating PCI patients. DAPT can minimize thrombotic adverse events that occur not only at the stented lesion, but along the whole coronary tree. However, DAPT has a critical side effect of increasing bleeding complications. Addressing the clinical imperatives of lowering bleeding while preserving ischemic benefit requires therapeutic strategies that decouple thrombotic from hemorrhagic risk.
* Recently, the ARC definition of high bleeding risk (HBR) has been published, so as to stress the need of optimal DAPT treatment in HBR patients. Due to the definitely higher bleeding risk in HBR patients, it would be rather more straight forward to titrate the optimal DAPT duration in these patients. In this line, many studies are in progress on HBR patients, with an ultra-short DAPT duration (i.e. Leaders free, Onyx ONE, Master DAPT, Xience 28, Xience 90, Evolve short DAPT trial, etc.).
* As a counteract to the definition of HBR, there is a concept of LBR. Due to the relatively vague ischemic/bleeding risk in LBR patients, balancing ischemic and bleeding complications post-PCI is more difficult in LBR patients, which may be a more important dilemma for clinicians. In this regards, limited evidence exists on the optimal duration of DAPT in LBR patients. Various previous studies that have evaluated the optimal DAPT in PCI populations, did not have the concept of HBR or LBR, making interpretation difficult.
* Therefore, this study is planning to compare the efficacy and safety of different DAPT durations, in patients stratified according to the ARB-HBR definition.


Eligibility Criteria:
* Inclusion Criteria:

  1. The patient agrees to participate in this study by signing the informed consent form. Alternatively, a legally authorized patient representative may agree to the patient's participation in this study and sign the informed consent form.
  2. The patient in whom the Bleeding Risk (according to the ARC-HBR classification) can be calculated.
  3. The patient has a working diagnosis of coronary artery disease which has been treated with percutaneous coronary intervention.
* Exclusion Criteria:

  1. Hypersensitivity to aspirin or P2Y12 inhibitors
  2. Patients in whom coroanry artery disease has been decided to be medically managed without a coronary stent.
  3. Positive pregnancy test or is known to be pregnant
  4. Any other reason the investigator deems the subject to be unsuitable for the study (e.g., Any life-threatening condition with life expectancy less than 6months, etc.)
Injectable Platelet-rich Fibrin and Advanced Platelet-rich Fibrin With Xenograft on the Socket Preservation of Mandibular Extracted Molars

Different materials and techniques are employed for socket preservation to reduce the alveolar bone resorption in both the horizontal and vertical dimensions as well as the soft tissue collapse after tooth extraction. Because of the repair abilities of the growth factors and proteins released by platelets, the development and application of platelet-enriched preparations have revolutionised the area of regenerative medicine.The present study will be designed to study the difference between A-PRF and IPRF with the addition of Xenograft in the preservation of bone in mandibular molars.


Eligibility Criteria:
Inclusion Criteria:

* Patients who need extraction of hopeless mandibular molars
* Teeth with advanced caries not amenable for conservative treatment
* Patients who are willing and fully capable of complying with the study protocol.

Exclusion Criteria:

* Systemic diseases that prevent surgery
* Acute or chronic oral infections
* Periodontal diseases
* Heavy smokers or alcoholics
* On anticoagulant drugs.
* Pregnancy
* History of radiotherapy or chemotherapy of the head and neck region
The Effect of Oral Contraceptive Pills On Eyes

The investigators aimed to evaluate the effect of oral contraceptive pills(OCP) on macula, retinal nerve fiber layer and choroid thickness by using Optical Coherence Tomography (OCT). The present clinical study is the first research reported in the literature which is investigating the posterior ocular segment changes in women using OCP by using OCT.

Spectral-domain optical coherence tomography (OCT) which is used to evaluate retina both qualitatively and qualitatively is a non invasive process. And also OCT makes it possible to perform retinal exams repeatedly without eye drops and dilatation.

Eligibility Criteria:
Inclusion Criteria:

* All the participants in the study group were Caucasian origin and the ages of them ranged from 18 to 48 in the reproductive period

Exclusion Criteria:

* None of the women in the study was pregnant. Women who reported histories of any medical problems such as thyroid disorders, hypertension, thromboembolic disease, diabetes mellitus, cardiovascular events, Cushing disease, positive malignancy, congenital adrenal hyperplasia, liver disease, psychotic disorders and neither did they use antidepressants nor steroidal hormone drugs and mood stabilizers (lithium, valproic acid, cocaine, antiandrogens, and insulin sensitizers, etc) were excluded from the study. Subjects were also excluded if they used caffeine or tobacco. The investigators also excluded from the study those women who had ocular surgery, ocular trauma or any ocular diseases such as glaucoma, cystoid macular edema, macular degeneration, optic atrophy, intraocular pressure 421 mmHg, cataract, best corrected visual acuity worse than 20/30, high spherical4± 3 dioptre or cylindrical42 dioptre refractive errors and uveitis at the time of OCT measurement.
Inferior Vena cavaCollapsibility Index in Patients With Acute Kidney Injury

This is an observational study that will examine the possibility of determining the type of Acute Kidney Injury (AKI) using bedside ultrasound machines.

The investigators hypothesize that different types of AKI (pre-renal, renal, and post-renal) are associated with different inferior vena cava diameters and collapsibility index. The investigators will include subjects ages 18-89 years with AKI (creatinine of 2mg/100ml or higher for less than 24 hours from baseline creatinine ≤1.2 or with unknown baseline creatinine). Standard of care treatment will not be different for patients taking part in this study. Participants will have bedside ultrasounds on days 0, 1, and 3, and baseline and follow-up data will be collected from medical records.

Eligibility Criteria:
Inclusion Criteria:

1. Creatinine of 1.7 mg/100ml or higher for less than 24 hours from baseline creatinine ≤1.2 or with unknown baseline creatinine
2. Age range: 18-89 years
3. Age range ≥ 18

Exclusion Criteria:

1. Only chronic renal disease will exclude a patient from our study regardless of past medical history and medications they are taking. (For the purposes of this study, any patient with creatinine higher than 1.2 mg /100ml for more than 24 hours will be identified as having chronic renal disease.)
Remote Ischaemic Preconditioning for Heart Surgery (RIPHeart-Study)

The purpose of this study is to evaluate the effects of Remote Ischaemic Preconditioning on perioperative ischaemic injury in patients undergoing cardiac surgery compared to control intervention.

Cardiac surgery with cardiopulmonary bypass is associated with a predictable incidence of myocardial, neurological and renal dysfunction. This significant morbidity and mortality is at least partly due to perioperative ischaemia. Remote ischaemic preconditioning (RIPC) is a novel, simple, non-invasive and inexpensive intervention by which ischaemia of non-vital tissue (skeletal muscles) protects remote organs (heart, brain and kidney) from a subsequent sustained episode of ischaemia. The investigators perform a multicenter randomized controlled study to evaluate that RIPC reduces teh severity of perioperative ischaemic injury in patients undergoing cardiac surgery, and results in about 1/3 risk reduction in the occurence of major adverse events.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing heart surgery on cardiopulmonary bypass

Exclusion Criteria:

* age \< 18
* Emergency cases
* left ventricular ejection fraction less than 30%
* current atrial fibrillation
* Inability to give informed consent
* preoperative use of inotropics or mechanical assist device
* severe liver, renal and pulmonary disease
* recent myocardial infarction (within 7 days)
* recent systemic infection or sepsis (within 7 days)
* severe stroke (within 2 months)
* peripheral vascular disease affecting upper limbs
* previous serious psychiatric disorders (e.g. schizophrenia, dementia)
* concomitant carotid endarterectomy
* rare surgeries: cardiac transplantation, correction of complicated congenital anomalies, pulmonary thromboembolectomy, off-pump surgery, minimal-invasive operation without sternotomy
Effect of Adding Magnesium Sulphate in Pericapsular Nerve Group Block

Our aim will be to compare the analgesic efficacy and safety of magnesium sulphate as an adjuvant to bupivacaine in pericapsular nerve group block in Hip joint surgeries.

* Our primary outcome of the study: total amount of postoperative morphine consumption in the first 24h postoperative.
* Our secondary outcome of the study: mean arterial blood pressure, heart rate, respiratory rate, adverse effects, block related complication, sedation score (by Ramsay sedation scale) and pain score (by Visual Analog Scale)


Eligibility Criteria:
Inclusion Criteria:

* • Patients aged 18 years or more.

  * Patients with American society of anesthesiologists (ASA) classification class I or II
  * Patients weight range from 50 to 90 Kgs

Exclusion Criteria:

* • Patient refusal of peripheral nerve block

  * Patient with infection at the site of injection
  * Patient with coagulopathy
  * Patients with known allergy to used medications.
Exploring Novel Interventions to Improve Adherence in Children With Cystic Fibrosis

The investigators know that adherence to medications in children with cystic fibrosis (CF) is poor. Forgetfulness has often been reported as a barrier to adherence by both CF patients and their parents. Many of the investigators patients also report being motivated by the results of their lung function studies (PFTs) to stay adherent to their medications. In this study, the investigators would like to see if providing medication reminders and allowing patients to measure their lung function at home will lead to better adherence. This will be a pilot study to determine the feasibility of providing such as a device to children with CF.

This is a randomized controlled trial to assess the impact of home lung function monitoring and medication reminders on adherence, clinical outcomes and quality of life in children with cystic fibrosis (CF) who are between 10 and 21 years of age.

Participants will be randomly assigned to either an intervention group or a control group. Those in the intervention group will receive a personal spirometer device that provides medication reminders and allows for lung function monitoring at home. The control group will receive the current standard of care. All participants will be aware that their adherence is being monitored over the course of the study using prescription refill data. Changes in lung function, body mass index and rate of hospitalization will be used as measures of clinical outcome. Responses to age-appropriate well-validated patient questionnaires will be used to assess the impact of the investigators interventions on quality of life and perceptions of treatment burden.

Since this device has never been previously studied in this patient population, the investigators would like to do a pilot study with 5 patients (3 in the intervention group and 2 in the control group) over a 3-month period to determine feasibility. This will also help us with the investigator power calculations and ultimately deciding the number of participants that will be needed for the larger study.

Eligibility Criteria:
Inclusion Criteria:

1. Age 10-21 years
2. Confirmed diagnosis of cystic fibrosis (CF) either by a sweat chloride ≥ 60mEq/L or the presence of two disease-causing mutations
3. Patients must be clinically stable with at least 1 month from their last hospitalization or use of oral antibiotics for a pulmonary exacerbation
4. Signed informed consent from the patient and/or from the parent/legal guardian, if younger than 18 years.

Exclusion Criteria:

1. Age less than 10 years or greater than 21 years
2. Clinically unstable
Whole Body Vibration Effect on Trunk Control, Functional Performance and Selective Control

Permanent neurological disorders such as cerebral palsy lead to problems with motor, sensory, and cognitive functions, which in turn limit one's ability to do certain activities. While the exact causes of cerebral palsy differ from child to child, anoxia-induced brain injury is a major cause of the disorder. The body parts affected, tone, and involuntary motions are used to categorise cerebral palsy. Among all the forms, spastic CP is the most prevalent. In individuals with CP, postural stabilisation and adaptations of the head, trunk, pelvic, and shoulder girdles grow more slowly. The primary problem with CP children is their gross movement pattern, which prevents them from performing single joint movements. Muscle strength increases significantly with WBV exercise training, which also reduces spasticity and enhances CP children's motor function. This study is important because it will determine whether WBV improves trunk control, functional performance, and lower limb selective control.

Data from Rising Sun Institute will be gathered for this randomised clinical trial. 38 patients will be included in the study. The study's inclusion criteria will include CP children with ages between 6 and 12 years old, those who can stand or walk alone (even with unusual gait patterns), GMFCS I and II, and children with diplegic cerebral palsy. Children with cerebral palsy (CP) who have had a lower limb fracture, fixed contracture, or other deformity, as well as those who have had a botulinum toxin injection or selective dorsal rhizotomy within the last six months, will not be eligible. Stretching exercises, strengthening exercises, trunk control facilitation, and rightening reaction facilitation will be the specific physical therapy treatments administered to group A. In addition, group B will receive WBV in addition to the specific physical therapy treatments (stretching exercises, strengthening exercises, trunk control facilitation, and rightening reaction facilitation). For two months, the 30-minute sessions will be held three times a week. The Modified Trost Test will test selective lower limb control, the PEDI scale will assess functional performance, and the Trunk Control Measurement Scale will monitor trunk stability before and after sessions. SPSS version 26 will be utilised for data analysis.


Eligibility Criteria:
Inclusion Criteria:

* • Childrens who follow verbal command

  * Childrens who can stand or walk alone (either with altered pattern)
  * Age limit: 6 -12 years
  * GMFCS I \& II
  * Diplegic Cerebral palsy

Exclusion Criteria:

* • Childrens with history of fracture in last 6 months

  * Childrens with fixed contracture or other deformity of lower limb
  * Childrens having visual or auditory impairments
  * Selective dorsal rhizotomy or botulinum toxin injection to lower extremities within past six months