cyrilzakka/clinical-trials huggingface dataset:
Impact of a Telerehabilitation Program With Technology Enhancement on Post-burn Recovery

The purpose of this study is to examine the effect of participating in a tele-rehabilitation program after a burn.

This is a prospective single center randomized trial comparing a traditional approach to physical therapy to a technology-enhanced approach following a burn. We hypothesize that with the implementation of a novel telerehabilitation program incorporating technology enhancement, range of motion and quality of life can be improved. To test the hypothesis in future grant applications, this pilot study will be used to determine feasibility, collect preliminary data, vet endpoints, and gain patient feedback. To achieve these necessary goals, we will compare two methods of supporting home performance of prescribed physical and occupational therapy: Standard (S): patients will be equipped with paper instructions for their physical therapy exercises; and Technology-Enhanced (TE) support: patients will be given paper instructions, set up with a habit and productivity application (Avocation) that gamifies tasks and tracks achievements, a Fitbit activity tracker, a logbook, and have virtual movement therapy once weekly with an exercise physiologist for a total of four weeks.

Specific Aim 1: To determine whether range of motion is altered with TE. Range of motion in the affected joint(s) will be measured by goniometry (self-reported by patient and measured by study staff in the clinic)

Specific Aim 2: To determine whether TE with prescribed movement affects scar, pain, and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Adults: ≥18 to ≤79 years of age
* Not participating in another interventional trial
* Admitted to the Blocker Burn Unit for treatment of initial burn
* Subject is able and willing to follow the protocol requirements
* Burn wound / scar / contracture occurring across at least one joint.
* Has regular access to smart phone, tablet, or computer with internet access.

Exclusion Criteria:

* Any medical condition that, in the opinion of the investigator or physician, would place the subject at increased risk for participation.
* Concurrent participation on another interventional clinical trial
* History of prior non-compliance or the presence or history of psychiatric condition (including drug or alcohol addiction) that would, in the opinion of the investigator, make it difficult for the subject to comply with the study procedures or follow the investigators instructions.
* Patients without internet access.
A Combined School- and Home-Based Sleep Promotion Program

The goal of this single group trial is to test the feasibility and acceptability of a combined school- and home-based sleep promotion program for young children prior to the kindergarten transition.

This single group pilot study will test a combined school- and home-based sleep promotion intervention designed to improve young children's sleep and classroom behavior. All participants will receive the intervention. Intervention content will be delivered via text message to parents' phones and in the classroom. The primary aim of this study is to assess the feasibility and acceptability of the intervention. The secondary aim is to assess the preliminary signal of effect on children's sleep and classroom behavior. Findings from this study will inform any necessary intervention modifications prior to a pilot randomized controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* Child between the ages of 4-6 years
* Currently enrolled in a participating school's 4-year-old kindergarten (4K) classroom
* Parent/guardian willing to complete questionnaires in English
* Parent/guardian must have access to a mobile phone with texting capability

Exclusion Criteria:

* Parent or child has a medical condition that impairs their ability to participate
Cryotherapy Versus Radiofrequency Catheter Ablation Research Program

A program of research has been set up at St. George's Hospital, London studyng the practicalities of catheter ablation. The current practice of catheter ablation is being studied for a range of arrhythmias including PAF, persistent AF, advanced persistent AF and resistant WPW.

The study design will be a separate randomised clinical trial for each of the arrhythmias studied. There will be 1:1 randomisation to either the cryotherapy protocol or RF protocol. Arrhythmia patients already under the care of this cardiac centre, who have already opted for catheter ablation treatment will be approached to ask if they will also be willing to participate in this longterm research program.

The protocols for each different arrhythmia are in line with current practice and knowledge and utilising current technology. In the program, the investigators have 1 or 2 protocols that mildly differ from conventional use but have already passed through initial experience with publication on this- this is the multi-catheter cryocatheter approach.

Acute procedural outcomes, short, medium and longterm success will be recorded for each patient, in addition to patient or participant experience and quality of life outcomes.

The catheter ablation research program has passed through ethical panel review in London and has the potential to become a multi-centre study.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients under the care of the Arrhythmia Service at St. George's Hospital with one of the studied arrhythmia (PAF, persistent AF etc), awaiting catheter ablation treatment will be eligible for inclusion to the program of research

Exclusion Criteria:

* Vulnerable patients will be excluded- e.g. active cancer, inability to consent
* Paediatric patients will not be studied
* Patients awaiting standard SVT catheter ablation treatment
Clinical Evaluation of a Normoproteic Diet

The main objective of this trial is the clinical evaluation of a normoproteic diet, when this diet is used for total enteral nutrition in geriatric people.

For 3 months,all the participants in the study will receive only tube feeding: The experimental group will receive the commercial preparation to evaluate (T-Diet Plus ®, Vegenat SA) and the control group will receive a standard diet (Jevity ®, Abbott Laboratories).

The project includes:

* Product tolerance study: gastrointestinal and metabolic complications related to the product administration.
* The monitoring of the intervention, and clinical and nutritional evaluation of the participants, including anthropometry, quality of life related to the health and clinical and nutritional status analytical evaluation (hematology and biochemistry).
* The determination of the major biochemical variables related to the lipid profile and assessment of the antioxidant defense system, and also certain markers of metabolic syndrome and associated cardiovascular risk.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 65 years old, of both sex, receiving total enteral nutrition by tube.
* Admitted to medically supervised institutions (homes, health centers).
* Requirement for total enteral nutrition standard, at least 3 months.
* Acceptance volunteer to participate in the study by signing the written informed consent (approved by the Ethics Committee of University Hospital Virgen de las Nieves).

Exclusion Criteria:

* Patients who receive drugs with lipid composition.
* Unstable clinical situation.
* Patients with terminal illness.
* Refusal or physical or mental inability to cooperate in the study.
* Participating in another study.
* Other causes: social causes, humanitarian, non-cooperation, etc..
Treatment Outcome With a Revascularization Protocol Using the Triple Versus Double Antibiotic Paste

The purpose of this study is to determine the treatment outcomes in permanent teeth with necrotic pulp and immature root development that undergo a regenerative procedure using a triple antibiotic paste (ciprofloxacin, metronidazole, minocycline) versus a double antibiotic paste (ciprofloxacin, metronidazole)compared to the commonly used mineral trioxide aggregate (MTA) apexification treatment.

Recent case series have reported positive outcomes treating necrotic immature permanent teeth with a regenerative procedure using a triple antibiotic paste (ciprofloxacin, metronidazole, minocycline). However, this method can result in considerable staining due to minocycline. In this randomized clinical trial, we will compare clinical outcomes of a triple antibiotic paste versus a double antibiotic paste (ciprofloxacin, metronidazole) intracanal medicament as compared to a standard treatment (immediate apexification with MTA) in permanent teeth with necrotic pulps and immature root development. We hypothesize there will be no significant differences between radiographic measures of root development after treatment with either the double versus triple antibiotic paste, and that both methods will produce significantly greater increases in root length and width compared to standard treatment. The primary outcome measures will be radiographic measurement of root length and dentinal wall thickness and the secondary outcomes will be lack of clinical symptoms and crown staining.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of pulpal necrosis with apical periodontitis
* patients 7-60 years of age
* maxillary or mandibular restorable single rooted immature permanent tooth with open apices
* acceptance of treatment plan with revascularization procedure
* healthy patient (ASA Class I or II physical status) with no systemic health problems

Exclusion Criteria:

* non-restorable teeth
* patients with ASA Class III or IV physical status (Immuno-compromised patients including patients who self-report to be a carrier of HIV, undergoing steroid therapy, or those who self-report with genetic or systemic diseases that could result in reduced immune response.
* child subjects unable to give assent
Decitabine for Chemotherapy Unfit Korean AML Patients in Real Practice

Prospective multicenter, open-lab el, observational, single arm study of decitabine. Subjects will be elderly patients with newly diagnosed, treatment-naïve AML who are unfit to receive and not candidate for intensive induction chemotherapy (iIC)


Eligibility Criteria:
Inclusion Criteria:

1. Newly diagnosed and therapy-naïve AML (bone marrow or peripheral blood blast counts ≥20%)
2. 65 years of age or older
3. Taking informed consent with signature and date
4. Not eligible for iIC based on either:

i) ≥75 years of age ii) comorbidity iii) secondary AML iv) poor performance (ECOG ≥2) v) Poor-risk by NCCN Guideline version 1.2015 vi) subject's choice (refusal for iIC) investigator's judgement incompatible with iIC

Exclusion Criteria:

1. Candidate for iIC at the time of enrollment
2. Promyelocytic leukemia, or AML with t(15;17) or PML/RARα rearrangement
3. AML with t(9;22) or BCR/ABL rearrangement
4. Leukemia central nervous system involvement
5. Extramedullary myeloid sarcoma without bone marrow involvement
6. Prior treatment with decitabine or azacitidine of any cause
7. Any leukemia-specific therapy, except for hydroxyurea for reducing leukemic cells prior decitabine
8. Second malignancy currently requiring active therapy except breast or prostate cancer stable on or responding to endocrine therapy, or curatively resected non-melanoma skin cancer or intraepithelial cancer
9. Premenopausal woman
10. Severe active infection
11. Uncontrolled bleeding Hypersensitivity to decitabine
Effect of Early Limited Formula Use on Breastfeeding Outcomes

The aim of this study is to conduct a pilot randomized controlled trial of the effect of early limited formula supplementation on breastfeeding-related outcomes for infants with high early weight loss. The investigators will enroll 40 exclusively breastfeeding infants at 24-48 hours of age and will randomly assign them to early limited formula supplementation following nursing (intervention group) or to no formula feeding (control group). Both groups will receive intensive lactation support. Outcome variables will include breastfeeding status on day-of-life 8, weight nadir, breastfeeding self-efficacy, maternal satisfaction, and exclusive and partial breastfeeding at 1-3 months. The hypothesis for this study is that early limited formula supplementation might help infants with early weight loss avoid eventual weight loss ≥ 10% and associated breastfeeding problems.


Eligibility Criteria:
Inclusion Criteria:

* Healthy term infants (37 to 42 weeks gestation)
* Infants who have lost 5% of their birth weight at \<36 hours of age

Exclusion Criteria:

* Infants who have received formula or water
* Mothers who are producing mature milk supply
* Infants receiving Level II or Level III care other than healthy term infants with routine complete blood count and blood tests pending
Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination (LixiLan) to Insulin Glargine Alone on Top of Oral Anti-diabetic Drugs (OADs) With Type 2 Diabetes in Japan

Primary Objective:

To compare LixiLan to insulin glargine in glycated hemoglobin (HbA1c) change from baseline to Week 26 in patients with type 2 Diabetes.

Secondary Objective:

To compare the overall efficacy and safety of LixiLan to insulin glargine (with or without OADs) over a 26 Week treatment period in patients with type 2 Diabetes.

The maximum study duration per patient will be approximately 29 weeks: an up to 2-week screening period, a 26-week randomized open-label treatment period and a 3-day post-treatment safety follow up period.

Eligibility Criteria:
Inclusion criteria :

* Patient with type 2 diabetes mellitus (T2DM) diagnosed for at least 1 year before the screening visit, receiving 1 or 2 OADs that can be Biguanide,Thiazolidinedione (TZD), -Alpha-glucosidase-inhibitor (alpha-GI),Sodium glucose co-transporter 2 (SGLT2) inhibitor,Sulfonylurea (SU),Rapid-acting insulin secretagogue (Glinide),diphenyl-peptidase -4 inhibitor (DPP-4 inhibitor).
* Signed written informed consent.

Exclusion criteria:

* At the screening visit: Age \<20 years.
* At the screening visit: HbA1c \<7.5% or \>9.5%.
* At the screening visit: fasting plasma glucose (FPG) \>180 mg/dL (10.0 mmol/L).
* Pregnancy or lactation, women of childbearing potential with no effective contraceptive method.
* Use of oral or injectable glucose-lowering agents other than those stated during the inclusion criteria in the 3 months before the screening visit.
* Previous treatment with insulin (except for short-term treatment due to intercurrent illness including gestational diabetes at the discretion of the trial physician).
* Laboratory findings at the time of screening:
* Amylase and/or lipase: \>3 times the upper limit of the normal (ULN) laboratory range,
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST): \>3 ULN,
* Calcitonin ≥20 pg/mL (5.9 pmol/L),
* Positive serum pregnancy test in female of childbearing potential.
* Contraindication to use of lixisenatide according to the local labeling. History of hypersensitivity to any Glucagon-Like Peptide-1 Receptor Agonists or to metacresol.
* Contraindication to use of insulin glargine according to local labeling. History of hypersensitivity to insulin glargine or to any of the excipients.
* Patient who has a severe renal function impairment with estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m\^2 or end-stage renal disease for patient not treated with metformin.
* Personal or immediate family history of medullary thyroid cancer (MTC) or genetic condition that predisposes to MTC (eg, multiple endocrine neoplasia syndromes).
* History of pancreatitis (unless pancreatitis was related to gallstones and cholecystectomy has been performed), pancreatitis during previous treatment with incretin therapies, chronic pancreatitis, pancreatectomy, stomach/gastric surgery.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
A Study of Retatrutide (LY3437943) in Participants With Type 2 Diabetes Mellitus Who Have Obesity or Overweight

The purpose of this study is to is to evaluate the efficacy and safety of retatrutide in participants with type 2 diabetes in participants who have obesity or overweight (J1I-MC-GZBK master protocol) including a subset of participants who have obstructive sleep apnea (OSA) (J1I-MC-GSA2). The study will last about 89 weeks and will include up to 24 visits.


Eligibility Criteria:
Inclusion Criteria:

* Have a body mass index (BMI) greater than or equal to 27.0 kilogram/square meter (kg/m ²)
* Have Type 2 Diabetes (T2D)
* Are on stable treatment for T2D for at least 90 days
* Have a history of at least one unsuccessful dietary effort to lose body weight.

GSA2 Inclusion Criteria

* Previously diagnosed with OSA
* Have AHI ≥15 on polysomnography at screening (definition of moderate-to-severe OSA)
* For participants not on positive airway pressure (PAP) therapy: unable or unwilling to use PAP therapy and have not used PAP for at least 4 weeks prior to screening.
* If on PAP therapy, have been on PAP therapy for at least 3 consecutive months prior to screening, and willing to temporarily stop using PAP therapy for approximately 7 days prior to each of the sleep study (PSG) visits.

Exclusion Criteria:

* Have a self-reported or documented change in body weight \>5 kg (11 pounds) within 90 days.
* Have taken weight loss drugs, including over-the-counter medications, within 90 days prior to screening.
* Have a prior or planned surgical treatment for obesity.
* Have Type 1 diabetes
* Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
* Have had pancreatitis

GSA2 Exclusion Criteria

* Use stimulants (for example, modafinil, armodafinil, solriamfetol, pitolisant, amphetamine) less than 3 months prior to screening.
* Use hypnotics, mirtazapine, opioids, trazodone, and zonisamide less than 3 months prior to screening.
* Use a dental appliance or other device to treat OSA other than PAP therapy.
A Study of Tenecteplase for Restoration of Function in Dysfunctional Central Venous Catheters

This was a Phase III, open-label, single-arm study that was conducted at 43 centers in the United States and Canada. 251 adult and pediatric patients with dysfunctional central venous catheters (CVCs) were enrolled in the study and treated with one or two doses of tenecteplase.


Eligibility Criteria:
Inclusion Criteria:

* Clinically stable, in the opinion of the investigator
* CVC occlusion
* Able to have fluids infused at the volume necessary to instill study drug into the CVC

Exclusion Criteria:

* Able to have 3 mL of blood (patients weighing ≥ 10 kg) or 1 mL of blood (patients weighing \< 10 kg) withdrawn from the selected CVC following patient repositioning
* Selected study CVC inserted \< 2 days prior to treatment
* Selected study CVC implanted specifically for hemodialysis (HD) or internally coated with any therapeutic agent
* Use of a power injector on the selected study CVC during study drug treatment
* Evidence of mechanical, non-thrombotic occlusion of the selected study CVC (e.g., kink in the catheter or suture constricting the catheter)
* Previously treated in this study or any tenecteplase catheter clearance trial
* Use of any investigational drug or therapy within 28 days prior to treatment
* Use of a fibrinolytic agent (e.g., alteplase, tenecteplase, reteplase, or urokinase) within 24 hours prior to treatment
* Known to be pregnant or breastfeeding at screening
* Known bacteremia or known or suspected infection in the CVC catheter
* Known history of intracranial hemorrhage (within the previous 3 years), intracranial aneurysm, or arteriovenous malformation
* Use of heparin (unfractionated or low molecular weight) or any other anticoagulants within 24 hours prior to treatment, except heparin used for prophylaxis or intermittent or low-dose, continuous infusion of heparin to maintain catheter or vessel patency
* Subjects treated with warfarin only: international normalized ratio (INR) ≥ 3.0 within 7 days prior to Visit 1, or a target INR range that allows for an INR ≥ 3.0
* Initiation of or increase in dose of Plavix® (clopidogrel bisulfate) within 7 days prior to treatment
* At high risk for bleeding events or embolic complications (i.e., recent pulmonary embolus, deep vein thrombosis, endarterectomy, or clinically significant right-to-left shunt) in the opinion of the investigator, or with known condition for which bleeding constitutes a significant hazard
* Known hypersensitivity to tenecteplase or any component of the formulation
Gingival Crevicular Fluid Levels of Protein Carbonyl Following the Use of Lycopene in Chronic Periodontitis

Effect of Locally Delivered Antioxidants as An Adjunct to Non-surgical Periodontal Therapy on GCF Level of Oxidative Stress Marker; Protein Carbonyl

The study was designed as a randomized controlled clinical trial. Total subjects selected were allocated into three study groups, Group I (Test group), Group II (Positive control group) and Group III (Negative control group). Group I: Included 8 patients with severe chronic periodontitis managed by Scaling and root planing and local delivery of lycopene loaded in solid lipid microparticles. Group II: Included 8 patients with severe chronic periodontitis managed by Scaling and root planing only. Group III: Included 8 patients with clinically healthy periodontium.

Protein carbonyl biomarker level and clinical parameters were assisted to evaluate the effect of lycopene as an adjunct to scaling and root planing.

Eligibility Criteria:
Inclusion Criteria:

* All subjects were free from any systemic diseases.
* Subjects for group I and II were suffering from severe chronic periodontitis (Armitage et al., 1999).
* Group III included subjects with clinically healthy periodontium.
* All subjects were between 35-60 years old.
* Both genders were included.
* Subjects were able to return for follow up visits.
* Subjects agreed to sign a written consent after the nature of the study was explained.

Exclusion Criteria:

* History of scaling and root planing or periodontal surgery \< 6 months prior to initiation of the study.
* History of administration of antimicrobial drugs or over the counter antioxidants like Vit C, Vit B, β-carotene \< 6 months prior to the baseline examination.
* Subjects who reported any side effects or drug allergies from antioxidants.
* Subjects with mobile teeth, abscesses and defected restorations related to the affected sites.
* Subjects with para-functional habits.
* Pregnant and lactating females.
* Smokers, alcoholic and drug abusers.
* Prisoner.
* Mentally retarded patients.
Safety And Efficacy Study Of Once Daily Controlled Release Pregabalin In The Treatment Of Patients With Postherpetic Neuralgia

The purpose of the study is to explore the safety and efficacy of a new once a day pregabalin formulation versus placebo for patients with post herpetic neuralgia (Shingles)


Eligibility Criteria:
Inclusion Criteria:

* Patients must have pain present for more than 3 months after the healing of the herpes zoster skin rash.
* At screening (V1) and enrollment (V2), patients must have a score of greater than or equal to 4 on the Pain Numeric Rating Scale (1 week recall period).
* At enrollment (V2), at least 4 pain diaries must be completed satisfactorily within the last 7 days and the average pain score must be greater than or equal to 4.
* Male or female of any race, at least 18 years of age, and using appropriate methods of contraception

Exclusion Criteria:

* Creatinine clearance \<30 mL/min (estimated from serum creatinine).
* Skin conditions in the affected dermatome that could alter sensation
* Pregabalin use in the last 30 days. Subjects taking pregabalin in the last 30 days should be washed out of pregabalin for at least 30 days prior to screening visit. Patients who had not responded to pregabalin