cyrilzakka/clinical-trials huggingface dataset:
Effect of Platelet Rich Plasma (PRP) on the Esthetic Outcome and Scar Formation of Unilateral Cleft Lip Repair

The purpose of this study is to evaluate effect of platelet rich plasma on scar formation of unilateral cleft lip repair.

PRP is a portion of the plasma fraction of autologous blood, having a platelet concentration above baseline values. PRP is made by centrifugation of whole blood (drawn from a peripheral vein and stored in an acid citrate dextrose solution A (ACD-A) anticoagulant), which separates the various components of blood by their specific weight and increases the concentration of platelets.

Platelets are a rich source of the complex group of proteins called growth factors (GFs) involved in natural wound healing and in regeneration of injured tissues. GFs are active signals for attracting stem cells into the site of injury and triggering proliferation of these cells. PRP limit inflammation, interacting with macrophages to improve tissue healing and regeneration, promote new capillary growth, and accelerate epithelialization. Platelets in PRP also play a role in host defense mechanism at the wound site by producing signaling proteins that attract macrophages; PRP also may contain a small number of leukocytes that synthesize interleukins as part of a non-specific immune response. Previous studies of PRP have demonstrated antimicrobial activity against Escherichia coli, Staphylococcus aureus, including methicillin-resistant Staphylococcus aureus, Candida albicans, and Cryptococcus neoforma. So, PRP is effective in soft tissue healing, having no side effect and showed excellent healing score in skin wound healing.

Eligibility Criteria:
Inclusion Criteria:

* Patients with nonsyndromic cleft lip
* Primary, unilateral, complete or incomplete cleft lip
* Patient's age younger than six months
* Lip repair performed by one craniofacial surgeon
* Completeness of medical records including preoperative and postoperative photographs at approximately 6 months after surgery

Exclusion Criteria:

* Patients with syndromic cleft lip
* Secondary lip treatment (previous operated cases)
* Bilateral cleft lip
* Patient older than six months
* Associated Cardiac anomalies
* Any systemic condition
Antibacterial Effect and Clinical Performance of Chitosan Modified Glass Ionomer

The study is a randomized clinical trial that assesses the clinical success and the antibacterial effect on carious dentine of glass ionomer when modified with Chitosan and/or Titanium dioxide nano particles vs the control group of modification with Chlorhexidine as control when used in primary molars

Participants will be recruited from the acquitted to the clinic of pediatric dentistry department , Faculty of Dentistry of Ain Shams University. random allocation of the participants where indirect pulp capping is indicated so that modified Glass ionomer would be used as the filling material.

partial removal of caries is done then caries sample would be taken and sent for a microbiological evaluation and then, cavity dimensions is recoded, finally placement of the modified glass ionomer in the prepared cavity.

In a total period of 9 months the patients will be followed every 3 months for clinical evaluation and in the final visit the filling would be removed and another bacterial sample would be taken for comparison, then a permanent filling is placed.

Eligibility Criteria:
Inclusion Criteria:

The teeth will be primary molars selected from patients presented to the outpatient clinic that are

* Healthy patients.
* Age: 4-8 years.
* Children having at least one primary molar with only occlusal caries having dentine lesions wide enough for the smallest excavator to enter (Ø=0.9 mm).

Exclusion Criteria:

* Teeth with pulp involvement, those suffering from pain, irreversible pulpits or pulp necrosis.
* Children with systemic diseases.
* Patients with history of active para-functional oral habits, xerostomia.
* Patients who will have difficulties in cooperating.
Enhanced DPP-GLB to Promote Weight Loss Among Nonresponders in a Community-Based Lifestyle Intervention.

This study seeks to establish the efficacy of identifying weight loss nonresponders early in a Diabetes Prevention Program (DPP) intervention in 20 community settings (primarily churches and community centers) and providing them with individual-level, enhanced treatment through telephone contacts and access to additional resources. Additionally, potential mediators and moderators of the relationship between intervention status and weight loss response at 6 months in both nonresponders and responders will be examined and a cost-effectiveness analysis to evaluate the cost of the intervention will be conducted.

This study addresses key gaps in the literature about the weight loss effects of identifying nonresponders early and characterizing individuals who need more intense personalized strategies. The investigators hypothesize that changes between baseline and 3 months will be more pronounced among the nonresponders in the intervention group compared to the nonresponders in the active control group.


Eligibility Criteria:
Inclusion Criteria:

* self-described as Black
* non-diabetic
* body mass index (BMI) equal to or greater than 25
* CDC diabetes risk assessment greater than or equal to 5 or diabetes pre-diagnosis or history of gestational diabetes
* live within driving distance of participating church/site

Exclusion Criteria:

* diagnosed Type 1 or 2 diabetes
* pregnant or planning to become pregnant during study period
* contraindications to moderate physical activity
* serious medical condition that contradicts weight loss
* not Black or African American
Registry for Mitral Valve Surgery at Department of Cardiac Surgery University Hospital of Basel/ Switzerland

A registry is installed to collect (pre-, intra- and postoperative) data on patients undergoing mitral valve surgery at the Department for Cardiac Surgery of Universitätsspital Basel/ Switzerland since 2009. Retrospective data (since 2009) as well as prospective data are included in this ongoing registry to analyse the development of mitral valve surgery at the Department of Cardiac Surgery University Hospital of Basel/ Switzerland.


Eligibility Criteria:
Inclusion Criteria:

- patients undergoing mitral valve surgery at the Department for Cardiac Surgery of Universitätsspital Basel/ Switzerland since 2009

Exclusion Criteria:

- patients refusing consent for data use
Ticin for the Treatment of Coronary Lesions With Drug Eluting Ballons

The goal of this clinical trial is to compare the use of a specific drug eluting balloon (Magic Touch, Concept Medical®) versus standard drug eluting stent based strategies in patients with long coronary lesions.

Participants with chronic coronary disease and long coronary stenosis will be randomly assign to be treated either with Magic Touch balloon or drug eluting stent.

Patients at coronary angiography who are deemed suitable for PCI are assessed for eligibility. Patients fulfilling all inclusion and no exclusion criteria can be consented for trial participation. After successful lesion preparation, defined as residual stenosis less than 30%, TIMI flow 3 and no major (type C) dissection of target lesion, consented patients will be randomized in a 1:1 ratio to a drug eluting balloon(DEB)-based or standard drug eluting stent(DES)-based strategy and further randomized in a 1:1 fashion, stratified based on DEB vs DES, to undergo invasive follow-up at 6 (±30 days) or 12 (±30 days) months.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients (≥18 years old) with chronic coronary syndrome deemed suitable for PCI
2. At least one significant de-novo coronary lesion (defined as diameter stenosis \> 50% on angiography, with flow limiting features, confirmed with FFR ≤0.80 or iFR ≤0.89 and intended implantation of a long (≥30 mm) DES based on IVUS findings
3. Written informed consent

Exclusion Criteria:

1. Patients referred to the index procedure for an acute coronary syndrome
2. Target lesion involving the left main and/or ostial left coronary artery, ostial left circumflex artery or ostial right coronary artery
3. Severe renal impairment (eGFR\<15ml/min/1.73m2) or patient on dialysis treatment
4. Spontaneous coronary artery dissection (SCAD)
5. Contraindications to adenosine administration (e.g. moderate to severe asthma or chronic obstructive pulmonary disease, heart rate \<50 beats/min and systolic blood pressure \<90 mmHg)
6. Known pregnancy or breast-feeding patients
7. Life expectancy \<1 year due to other severe non-cardiac disease
8. Legally incompetent to provide informed consent
9. Participation in another clinical study with an investigational product
Multi-component Interventions to Increase HPV Vaccination in a Network of Pediatric Clinics

The purpose of the study is to determine the comparative effectiveness of a provider-only intervention and a parent plus provider intervention to increase initiation of HPV vaccination among male and female patients ages 11-17 in a large pediatric clinic network in the greater Houston area. The hypothesis is that HPV vaccine initiation will be higher in clinics randomized to the parent plus provider intervention compared with clinics randomized to the provider-only intervention.


Eligibility Criteria:
Inclusion Criteria:

* Patient at a Texas Children's Pediatrics clinic
* Patient had not initiated the HPV vaccination series at baseline

Exclusion Criteria:

- Patient had completed the HPV vaccination series at baseline
Laryngopharyngeal Reflux and Proton Pump Inhibitor (PPI) Treatment

This study proposes to investigate prospectively, the presence of molecular markers for inflammation in laryngopharyngeal reflux (LPR) patients and to study the effect of a proton pump inhibitor (Aciphex) on these molecular markers.

The investigators will be evaluating a group of patients before and after treatment. This group will be patients that have untreated laryngopharyngeal reflux diagnosed by laryngoscopic assessment and a 24-hour probe.

Objectives:

This study proposes to investigate prospectively, the presence of molecular markers for inflammation in LPR patients and to study the effect of a proton pump inhibitor on these molecular markers. This study will provide important data regarding the etiology of LPR. It will also provide vital information about the present standard treatment for LPR and why it is not universally successful.

Patient Selection Criteria:

The subject group will consist of 25 subjects who have untreated LPR diagnosed by laryngoscopic assessment and 24-hour pH probe.

Design:

The presence of proinflammatory cytokines will be measured at the gene and protein expression levels from PL biopsies with gene specific semiquantitative reverse transcription-polymerase chain reaction and Western Blot analysis.

Statistical Methods, Data Analysis, and Interpretation:

Null Hypothesis: There will be no difference in cytokine expression in the posterior larynx in patients with laryngopharyngeal reflux after 10 weeks of treatment with Aciphex, a proton pump inhibitor.

Alternative Hypothesis: There will be a difference in cytokine expression in the posterior larynx in patients with laryngopharyngeal reflux after 10 weeks of treatment with Aciphex, a proton pump inhibitor.

Effect size = 30% (based upon review of the literature for cytokines in inflammatory states)

Standard Deviation = 30

Standard Effect Size = effect size/standard deviation = 30/30 = 1

With an alpha of 0.05, power 0.1 (90% power), sample size should be 22. Therefore we have chosen 25 subjects in case of error in molecular studies.

Paired t-tests will be utilized to compare differences between cytokine levels for experimental group initiation and completion of medication.

Eligibility Criteria:
Inclusion Criteria:

* The subject group will consist of 25 subjects who have untreated LPR diagnosed by laryngoscopic assessment and 24-hour pH probe.
Sex-related Differences in Outcome After Hybrid Coronary Revascularization

Hybrid coronary revascularization (HCR) has emerged as a favorable technique over traditional coronary artery bypass grafting (CABG) in a select group of patients with multivessel coronary artery disease (CAD). Till date, multiple individual studies comparing HCR with CABG have been carried out, but no data on the potential impact of sex on the outcome of HCR exist.

To fill this knowledge gap, the investigators aim to perform an international collaborative multi-center study in order to examine gender differences in short-term and long-term outcomes among patients who underwent HCR or CABG.

Hybrid coronary revascularization (HCR) has emerged as a favorable technique over traditional coronary artery bypass grafting (CABG) in a select group of patients with multivessel coronary artery disease (CAD).

Till date, multiple individual studies comparing HCR with CABG have been carried out, but no data on the potential impact of sex on the outcome of HCR exist. Limited by their sample size, these individual studies may have been under-powered to detect a difference.

To fill this knowledge gap, the investigators aim to perform an international collaborative multi-center study in order to examine gender differences in short-term and long-term outcomes among patients who underwent HCR or CABG.

Eligibility Criteria:
Inclusion Criteria:

Patients with coronary artery disease and indication to cardiac surgery

Exclusion Criteria:

Contraindications to cardiac surgery
Combination Study of Urelumab and Rituximab in Patients With B-cell Non-Hodgkins Lymphoma

The purpose of the study is to determine the safety, tolerability and maximum tolerated dose of Urelumab in combination with Rituximab in patients with B-cell Non-Hodgkins Lymphoma

Intervention model: Dose Escalation (part 1) of study= Sequential Design; Dose Expansion (part 2) of study= Parallel Design

Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

* Clinical diagnosis of relapsed/refractory B-cell Malignancies (B-Non-Hodgkins Lymphoma (NHL)) per International Workshop Group (IWG)
* Progressed or refractory to at least 1 prior line of standard therapy
* Subjects in Expansion cohorts are restricted to relapsed/refractory diffuse large B-cell lymphoma (DLBCL) or Follicular Lymphoma (FL) subjects who are either relapsed or refractory to prior rituximab or ritxumab-containing chemotherapy regimens
* Follicular Lymphoma (FL) must have at least 1 lesion that can be biopsied at screening and on treatment
* Eastern Cooperative Oncology Group (ECOG) of 0 to 1

Exclusion Criteria:

* Active or progressing brain metastases
* Other concomitant malignancies (with some exceptions per protocol)
* Active or history of autoimmune disease
* Positive test for human immunodeficiency virus (HIV) 1\&2 or known Acquired immune deficiency syndrome (AIDS)
* History of any hepatitis (A, B or C)
* History of grade 3-4 drug-related hepatitis
* Known current drug or alcohol abuse
* Active tuberculosis (TB)
* Prior therapy with any antibody/drug that targets the T cell coregulatory proteins, including but not limited to, anti-CD137, Anti Cytotoxic T lymphocyte-associated antigen 4 (anti-CTLA4) or Anti-Glucocorticoid-induced tumor necrosis factor receptor (anti-GITR). However, Anti-Programmed Death-1 (anti-PD-1), Anti-Programmed Death-Ligand1 (anti-PD-L1) are permissible as prior therapy
Measuring Ability of Healthy Volunteers to Power a Bicycle-powered Oxygen Concentrator

The investigators would like to test how well healthy human volunteers power a modified oxygen concentrator. The investigators modified the oxygen concentrator to be powered by a bicycle instead of wall power so that it can be used in low resource countries where the power supply is unreliable.

The investigators would like to test how many healthy people can power the oxygen concentrator by pedaling the bike for at least 30 minutes. If the healthy volunteers can bike for at least 30 minutes, the investigators assume they are pedaling at or below their lactate threshold. The investigators have literature values which suggest bigger people should be able to output more work, and the investigators wish to use a sample of the population to verify that most of the people can power our system. The investigators have a good estimate of the power required by our system, and the investigators want to verify the average person can actually do what we calculated is necessary.

Eligibility Criteria:
Inclusion Criteria:

* Volunteers will be included if they are between 18 and 45 years of age and if they do not have physical restrictions which would preclude them from riding a bike for 30 minutes.

Exclusion Criteria:

* 1)anyone with known cardiovascular, pulmonary, or metabolic disease or

  2)an age of greater than 45 or

  3) one or more of the following symptoms:
  * On medication for their heart
  * Suffer from pains in their chest
  * Ever feel faint of have spells of severe dizziness
  * High blood pressure
  * Currently on blood pressure medication
  * Have a bone or joint problem such as arthritis that has been aggravated by exercise
  * Unaccustomed to vigorous exercise
  * Have experienced unusual heart beats such as skipped beats or palpitations
  * Experience shortness or loss of breath while walking with others your own age
  * Have been diagnosed with diabetes
Geriatric Education and Its Effect on Certain Aspects of Hospital Care of Nursing Home Patients

Nursing home patients admitted to the hospital pose a significant challenge for health care providers. Geriatric teaching pays particular attention to these admissions and related problems. However, it is yet to be proven, whether geriatric training helps to overcome any of these issues in a better way than through non-geriatric education. The study aims to prove that geriatric training provides advantages over non-geriatric training in caring for nursing home patients admitted to the hospital.

Context: Nursing home patients admitted to the hospital pose a significant challenge for health care providers. Geriatric age, frailty, multiple readmissions, prolonged length of stay, and high mortality are just a few attributes of nursing home patients in the hospital. Geriatric teaching pays particular attention to these challenging problems. However, it is yet to be proven, whether geriatric training helps to overcome any of these issues in a better way than through non-geriatric education.

Objective: To test the hypothesis that geriatric care provides advantages over non-geriatric training in caring for nursing home patients admitted to the hospital in regards to length of stay, rate of expirations and rate of readmissions. The secondary objective is to compare expirations and readmissions among patients cared for by geriatricians and non-geriatricians.

Design, Setting, and Participants: Retrospective cohort study of patients admitted from Metropolitan Jewish Geriatric Nursing Home (MJGNH) to Maimonides Medical Center (MMC) over a certain period of time and under the care of geriatricians, non-geriatric internists, and surgeons. Comparison of the three study groups by age, sex, expiration rate, length of hospital stay (LOS) and readmission rate. Comparison of expired patients by age, sex and average LOS. Comparison of readmissions, expiration rate, by preservation of continuity of care, and by emergency room visits without admission.

Eligibility Criteria:
Inclusion Criteria:

* All patients admitted to Maimonides Medical Center (MMC) from affiliated Metropolitan Jewish Geriatric Nursing Home (MJGNH) for a 3 month period.
Sphenopalatine Block Versus Greater Occipital Nerve Block in PDPH

Management of postdural puncture headache (PDPH) has always been challenging for anesthesiologists. PDPH not only increases the misery of the patient, but the length of stay and overall cost of treatment in the hospital also increases. Although the epidural blood patch ( EBP ) is an effective way of treating the problem, the procedure itself could cause another inadvertent dural puncture (DP). Moreover, sometimes patients need to have a second EBP, if the first one is not completely effective. This can be difficult to explain to the patient who has already suffered a lot. Peripheral nerve blocks are well tolerated and effective as adjunctive therapy for many disabling headache disorder.

Sphenopalatine ganglion is a parasympathetic ganglion, located in the pterygopalatine fossa. Transnasal sphenopalatine ganglion block ( SPGB ) has been successfully used to treat chronic conditions such as migraine, cluster headache, and trigeminal neuralgia, and may be a safer alternative to treat PDPH: It is minimally invasive and carried out at the bedside without using imaging. Besides that, it has apparently a faster start than EBP, with better safety profile.

Another minimally invasive peripheral nerve block which has been used quite successful is greater occipital nerve block (GONB). The GONB has been in use for more than a decade to treat complex headache syndromes of varying etiologies like migraine , cluster headache and chronic daily headache with encouraging results. Greater Occipital Nerve (GON) arises from C2-3 segments, its most proximal part lies between obliqua capitis inferior and semispinalis, near the spinous process. Then, GON enters into semispinalis passing through it and after its exit; it enters into trapezius muscle. In distal region of trapezius fascia, it is crossed by the occipital artery and finally the nerve exits the trapezius fascia insertion into the nuchal line about 5-cm lateral to midline. Functionally, GON supplies major rectus capitis posterior muscle, and the skin, muscles, and vessels of the scalp, but is the main sensory supply of occipital region.

Many providers believe that the local anesthetic produces the rapid onset of headache relief, like an abortive agent, and that the locally acting steroid produces the preventive like action of up to 6 weeks as dexamethasone possess potent anti inflammatory and immunosuppressive actions by inhibiting cytokine-mediated pathways .


Eligibility Criteria:
Inclusion Criteria:

* Obstetric patients ( American Society of Anesthesiologists ) ASA I\&II ,body weight between 60-100kg expressing PDPH after spinal anesthesia, (VAS \> 4 ) with standard treatment such as intravenous fluids, abdominal binder, bed rest and caffeine.

Exclusion Criteria:

* • ASA III\& IV patients.

  * Refusal of the patient.
  * Patients with chronic headache or migraine.
  * Hypertensive patients.
  * A patient that cannot comply with the VAS.
  * Infection at site of the block
  * Known coagulation defect.
  * Nasal septal deviation, polyp, history of nasal bleeding.
  * Allergy to local anaesthetics.