cyrilzakka/clinical-trials huggingface dataset:
Switch or Quit R01

This study evaluates whether non-cigarette tobacco products (e-cigarettes) can help smokers quit smoking as compared to traditional quit methods (nicotine replacement therapy or varenicline/Chantix). Participants in this study will be randomly assigned to one of two groups, then will have a choice between the offered products of that group. Participants in the e-cigarette group will have a choice of e-cigarette brand and flavor. Participants in the medication group will have choice between nicotine replacement therapy (patches and lozenges) or varenicline, also known as Chantix. Participation will last 6 months and will include weekly phone calls for the initial 7-weeks plus a 11-week phone call and a 6-month follow-up visit. Participants will also complete electronic daily diaries during the first 7-weeks.

Even though e-cigarettes have risen in prevalence over the last decade, data on the use of these products as harm reduction tools for smokers who try to switch completely is lacking.

These data are urgently needed for several reasons.

1. Clinicians cannot provide clear guidance to smokers who may be interested in switching. Questions from medical patients about e-cigarettes are on the rise, and data show that medical providers are providing mixed messages about the safety and utility of e-cigarettes, with some physicians discouraging their use and some recommending them as cessation aids.
2. Public health organizations are also providing mixed messages about the health risks of non-cigarette tobacco products-with some not recommending their use at all (The American Cancer Society, American Lung Association), and some acknowledging that complete switching to e-cigarettes would reduce health risks compared to continued smoking, but not recommending the use of these products over traditional methods (Centers for Disease Control, Food and Drug Administration).
3. In the absence of clear messaging about non-cigarette products, smokers who fail with traditional methods are continuing to smoke cigarettes, the most harmful tobacco product available.

The reviews underscore the need for additional data on this topic, especially data comparing the products to pharmacotherapy. The goal of the proposed study is to provide one of the first well-designed randomized controlled trials that addresses whether alternative tobacco products (e-cigarettes) have the potential to serve as harm reduction tools in a critical population-smokers who have tried to quit smoking using FDA-approved pharmacotherapy and failed to do so.

Eligibility Criteria:
Inclusion Criteria

* Adults 21+ who previously had a quit attempt using FDA-approved pharmacotherapy.
* Interest in reducing harms from tobacco use or quitting smoking

Exclusion Criteria

* Pregnant, breastfeeding, or trying to become pregnant.
* Household member currently enrolled in the study
* Planning to move out of the area within the next 7 months
Long-Term Safety and Effectiveness of MDMA-Assisted Therapy for PTSD

The goal of this long-term follow-up study is to measure how long effects of MDMA-assisted therapy last in participants with PTSD who were treated in a prior Phase 3 clinical trial of MDMA-assisted therapy.

The main question it aims to answer is: Does MDMA-assisted therapy result in lasting reductions in PTSD symptoms?

Participants who have received at least one dose of MDMA-assisted therapy will take a PTSD assessment at least six months after their last MDMA-assisted therapy session in the main study.

This non-interventional study will serve as the long-term follow-up (LTFU) protocol for MDMA-assisted therapy clinical trials and will measure persistence of effectiveness using the CAPS-5 as a measure of PTSD symptom severity. The primary objective of this study is to evaluate the long-term effectiveness of MDMA-assisted therapy for treatment of PTSD as measured by the change in CAPS-5 Total Severity Score (actual or imputed) from the main study Baseline and Study Termination to LTFU IR Assessments (Visit 1). Additionally, this study will gather data to support health economics and cost effectiveness analyses of this treatment. Participants who have received at least one dose of Investigational Medicinal Product (IMP) in the main study will be eligible to participate in this study.

Eligibility Criteria:
Inclusion Criteria:

1. Enrolled in a MAPS-sponsored study of MDMA-assisted therapy for the treatment of PTSD
2. Have received Investigational Medicinal Product (IMP) in at least one Experimental Session in the main study
3. Agree to be contacted by study team at least six months after the last Experimental Session in the main study to schedule and participate in LTFU visits

Exclusion Criteria:

1. Are not able to give adequate informed consent
2. Have any current problem which, in the opinion of the investigator or Medical Monitor, might interfere with participation
Effect of Vitamin D Supplementation on the Metabolic Control and Body Composition of Type 2 Diabetes Subjects in Ajman (UAE)

The incidence of type 2 diabetes mellitus and obesity is increasing at an alarming rate both nationally and worldwide. Accumulating evidence suggests that serum cholecalciferol levels may be inversely related to the prevalence of diabetes, insulin resistance and metabolic syndrome. However, to demonstrate a causal relation between vitamin D and glucose metabolism, evidence from randomized and adequately powered placebo-controlled intervention trials is needed.The trials available on the effect of Vitamin D supplementation are not conclusive. Hence, the purpose of this study was to conduct a double-blind randomized trial in Vitamin D deficient obese type 2 diabetic Emirati population to clarify the effect of vitamin D supplementation on glycemic control and obesity parameters.

Vitamin D insufficiency has been reported as a risk factor for the development of type 1 and type 2 diabetes mellitus. In contrast to the findings of the observational studies, the supplementation trials in type 2 diabetes mellitus (T2DM) do not report any definitive conclusions, but it does suggest that supplementation at an early stage in the development of diabetes may be of benefit in delaying progression to clinical T2DM by increasing the pancreatic insulin release and improved insulin resistance plus impaired glucose tolerance.There is also speculation on role of vitamin D in physiology of weight loss and body composition.However, there have been multiple inconsistencies within the reported trial i.e. sample size, dose of vitamin D, frequency of supplementation, and population studied.

Hence the randomised clinical trial was undertaken to study the effect of vitamin D (Cholecalciferol) supplementation on metabolic markers and obesity parameters in the vitamin D deficient obese type 2 diabetic subjects.

Eligibility Criteria:
Inclusion Criteria:

* United Arab Emirates national
* Male or Female
* Age 30-65 years
* Diagnosed as type 2 diabetes
* Body Mass Index ≥30 kg/m2
* Serum 25 hydroxy Vitamin D ≤ 50nmol/L

Exclusion Criteria:

* Type 1 diabetes mellitus
* History or evidence of liver failure (elevated liver function tests) or renal failure ( elevated creatinine)
* History of malabsorption syndrome.
* On vitamin D Supplementation
* On hormone replacement therapy
* On corticosteroids, anticonvulsants, AIDS medication
Stress Hyperglycemia and Acute Ischemic Stroke

Whereas diabetes mellitus is clearly a risk factor for the occurrence of stroke and for its poor prognosis, hyperglycemia per se is also linked to increased morbidity and mortality in stroke patients.Therefore, the objective of this work was to study the glycemic status of acute ischemic stroke patients and to assess its impact on stroke outcome.

Using PASS program, setting alpha error at 5% and power of 80%, the total sample size was estimated to be 80 cases.

The NIHSS was used as a primary outcome; 40 cases were needed in each group. Secondary outcomes were hemorrhagic transformation, hospital stay duration, mechanical ventilation, need for vasopressors, and 30-days mortality.

Eligibility Criteria:
Inclusion Criteria:

* Acute ischemic stroke within 24 hours of onset of symptoms

Exclusion Criteria:

* subdural hematoma
* Transient ischemic attack
* Subarachnoid hemorrhage
* Hemorrhagic stroke
* Major comorbidities Hyperglycemia on admission that was controlled (random blood sugar (RBS) \< 150 mg/dl) within 24 hours with insulin therapy, diabetic
* Ketoacidosis
* RBS less than 70 mg/dl on admission
Impact of Topical Antiadhesion Therapy on Wound Healing and Postoperative Pain After Anal Surgery

2QR-complex is a patented molecule extracted from Aloe vera barbadensis leaves that blocks the adhesion of pathogenic microbes to human epithelial cells and tissues \[9\]. Anti-adhesion therapy such as 2QR-complex has been suggested as an alternative to antibiotics in the treatment of bacterial infections. 2QR-complex based products have already shown comparable efficacy to antibiotics in treating mucosal infections such as bacterial vaginosis.

In the present study we aim to assess the efficacy of 2QR-complex in pain relief and promotion of anal wound healing after anal surgery. We presumed that anal discomfort and prolonged healing after surgery for anal fissure, fistula, and hemorrhoids may in part be due to contamination of the wound with fecal bacteria that colonize at the surgical site. Therefore, we assumed that the use of topical anti-adhesive 2QR-complex-based product may serve to minimize this negative impact on wound healing.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients of either sex with simple anal fistula, chronic anal fissure, or grade III/IV hemorrhoids will be included.

Exclusion Criteria:

* Patients with other anal conditions, diabetic patients, patients under steroid or immunosuppressive therapy will be excluded.
Effects of an Early Prehospital Administration of Tranexamic Acid on Hyperfibrinolysis in Multiple Trauma

Severe external and internal bleedings are common in multiple trauma patients. Uncontrollable blood loss is the cause for about one third of all trauma deaths. A number of blood clotting mechanisms are known to be triggered by major blood losses. These mechanisms shall secure the organisms from loosing even more blood. To avoid an overshooting clotting behavior, inhibiting mechanisms occur as well. An important inhibiting (or fibrinolytic) mechanism is the fibrinolysis that is based on the conversion of plasminogen to plasmin. In severe bleeding situations this mechanism tends to overshoot and therewith contributes to the severity of the bleeding. This phenomena is called hyperfibrinolysis and is found in approximately one third of all multiple trauma patients. Mortality rates are increased in these patients. Tranexamic acid is an antifibrinolytic drug that inhibits the conversion from plasminogen to plasmin and therefore is able to limit the effects hyperfibrinolysis. A large study showed positive influence of tranexamic acid on mortality rates and blood loss in severely injured patients, when it was administered in an early clinical setting. In this study we want to answer the question wether a hyperfibrinolysis can be seen in an early prehospital (on the scene) setting and how it is influenced by an early prehospital administration of tranexamic acid.

In patients suffering from multiple trauma the initially responding emergency physician on the scene will take a blood sample for thrombelastometry immediately after i.v. access is established. According to the initial trauma life support protocols a number of patients will receive a dose of tranexamic acid during the initial treatment on the scene or during transport to the hospital. A second blood sample will be taken after arrival in the resuscitation area of the hospital. Thrombelastometric measurements will be performed with both blood samples and the extent of hyperfibrinolysis in both samples will be compared. In a second step the outcome of the patients who received tranexamic acid on the scene will be compared to those who did not receive the drug before reaching hospital.

Eligibility Criteria:
Inclusion Criteria:

* Multiple trauma ISS \> 15
* Age \> 18 years

Exclusion Criteria:

* No informed consent
* Inclusion to an interventional clinical trial
* Death of the patient on the scene or before the hospital was reached
* Delayed thrombelastometric measurement (\> 4 hours)
Migraine Survey in Gulf Region

The objective of this study is to evaluate the effect of erenumab on medication-specific treatment satisfaction in patients newly started on erenumab over 12 weeks

This is a longitudinal prospective descriptive primary data collection using a 20 min online survey. Patients will be selected by investigators (general neurologists, headache/migraine specialists) in primary care clinics and hospitals. After fulfilling the inclusion criteria, the patient will be asked to sign an online informed consent. A 5 min screener will follow after which the patient will be directed through a link to the full survey. The duration of data collection will be for 6 months since the start of survey rolling in each site across centers in the Gulf Region.

Eligibility Criteria:
Inclusion Criteria:

* EM\& CM (with or without Medication Overuse Headache (MOH)) patients
* Newly Started on erenumab either 70 mg or 140 mg (first dose received within 1 month prior study enrollment and baseline endpoints collection)
* Ability to receive 3 monthly doses of erenumab.
* Age more than 18 years
* Males and Females
* Allowing the patients to be stable on 1 adjunctive migraine preventive medication (if present)
* Agreed to be included in the study and signed informed consent

Exclusion Criteria:

* Less than 18 years
* Age at onset of Migraine more than 50 years
* Any contraindications to the start of erenumab as per label
* Refusal to sign informed consent
* Inability to participate or restricted access to the online survey
* Enrolled in an interventional migraine-related study at the time of the study enrollement
Rebreathing-induced Hypoxia and Glucose Levels

The aim of this research project is to determine the effect of repeated maximal voluntary apneas on glucose uptake during an oral glucose tolerance test in healthy individuals, individuals with prediabetes and patients with type 2 diabetes.

It is predicted that 1 in 3 adults will develop diabetes by 2050, implying that a large percentage of the population will become at high risk for cardiovascular disease, the most common cause of death in patients with type 2 diabetes. While regular exercise reduces insulin resistance and the elevated glucose levels associated with type 2 diabetes, only 28% of the adult population with diabetes meet physical activity recommendations. There is therefore an urgent need to identify alternative, non-pharmacological interventions that prevent and treat type 2 diabetes.

A reduced oxygen availability, or hypoxia, is widely implicated in the development of insulin resistance. Paradoxically, hypoxia also triggers glucose uptake independently from the actions of insulin. Indeed, breathing low levels of oxygen stimulates glucose uptake in skeletal muscles by activating 5' adenosine monophosphate-activated protein kinase (AMPK). Discrepancies on the effect of hypoxia on glucose homeostasis may be attributed to the duration and type (nocturnal vs. diurnal) of hypoxic exposure. For example, the many severe hypoxic bouts associated with obstructive sleep apnea are associated with a worsened glycemic control while hypoxic exposure consisting of a limited number of short bouts of moderate hypoxia improves glycemic control. Therefore, an intervention that can induce brief hypoxic conditions, as observed through a reduced fraction of inspired oxygen, could attenuate the postprandial increase in glucose levels.

Fraction of inspired oxygen can be reduced by rebreathing into a low-volume closed-circuit system containing ambient air for few minutes. Thus, the aim of this research project is to determine the effect of few bouts of rebreathing-induced hypoxia on glucose uptake during an oral glucose tolerance test in healthy individuals, individuals with prediabetes and patients with type 2 diabetes. If our expected outcomes are met, our next step will be to determine whether repeated sessions of rebreathing-induced hypoxia (5 sessions per week over 1-3 months) results in improvements in glycemic control.

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 18 to 80 years old

Exclusion Criteria:

* Have uncontrolled stage 2 hypertension (˃140/90 mmHg)
* Are smokers
* Are pregnant
* Have a history of cardiovascular disease or indication of cardiovascular disease such as myocardial infarction, left ventricular hypertrophy, ischemic heart disease (or prior ischemia), stroke, and/or other vascular disease
* Have a history of lung disease
* Are taking insulin or more than one antihypertensive medication
* Have poorly controlled diabetes: HbA1c levels ˃ 9%
* Have been previously diagnosed with diabetic complications (nephropathy, neuropathy, retinopathy) by their family doctor
Optimised Recovery With Accelerated Nutrition and GI Enhancement

Factors which delay recovery following uncomplicated abdominal surgery include uncontrolled pain, intolerance of diet and poor mobility. Enhanced recovery after Surgery (ERAS) programmes are perioperative care pathways that address systematically these issues (i.e. improved dynamic pain relief, optimised nutritional care and enforced mobilisation) to promote a faster recovery and a shorter stay. The key treatments that improve outcome within an ERAS programme are not known. Moreover there are few acceptable, objective endpoints to assess key outcome variables such as return of GI function. This randomised trial will assess the potential synergy between early recovery of GI function (laxation) and early postoperative oral nutritional support(with associated preoperative preconditioning using carbohydrate/fluid loading). The main overall outcome targets being improved recovery of gastrointestinal function, postoperative nutritional status and physical function. It will validate the use of a novel, objective technique to measure gastric motility (surrogate for GI function). Such refinement of ERAS should result in shorter hospital stay and better use of limited health care resource.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing hepatic resection for benign or malignant conditions
* Able to understand the nature of the study and what will be required of them.
* Men and non-pregnant, non-lactating women
* BMI 18 - 30

Exclusion Criteria:

* Inability to give written, informed consent
* Patients with dementia or neurological impairment
* Patients with pre-existing condition limiting mobility
* Planned bile duct excision
* Repeat or staged procedures
* Central extended resections
* Underlying cirrhotic liver disease
* Jaundice (Bilirubin \> 50 μmol/L)
Vitamin D Replacement Using Oral Thin Film (OTF) Cholecalciferol in Patients Undergoing Hematopoietic Stem Cell Transplantation

The investigators hypothesize that vitamin D levels can be improved in hematopoietic stem cell transplantation (HSCT) recipients not responding or tolerating standard enteral supplementation options by using vitamin D oral thin film (OTF) administration.

The purpose of this study is to investigate efficacy of oral thin film (OTF) cholecalciferol (vitamin D3) replacement in hematopoietic stem cell transplantation (HSCT) recipients who failed to achieve or sustain adequate vitamin D levels after vitamin D supplementation using current standard of care, or those unable to take/tolerate currently available enteral vitamin D formulations. With oral thin film (OTF) cholecalciferol, investigators hope to significantly improve the ease of administration, restoring compliance and facilitating therapeutic vitamin D levels without relying on the gut for absorption.

Eligibility Criteria:
Inclusion Criteria:

* HSCT recipients of any age with vitamin D levels ≤35 ng/mL, or unable to tolerate, or refractory to enteral supplementation formulations of Vitamin D will be offered Vitamin D OTF.

Exclusion Criteria:

* Subjects with 25OHD level \>60ng/mL. Subjects can be re-screened multiple times and enrolled later if they meet study criteria.
* Subjects with clinically significant and uncontrolled hypercalcemia as deemed by treating physician.
Safety and Pharmacokinetics of Ceftolozane/Tazobactam in Pediatric Participants With Nosocomial Pneumonia (MK-7625A-036)

This is a phase 1, open-label, non-comparative, multicenter clinical study to evaluate the safety, tolerability, and pharmacokinetics of ceftolozane/tazobactam (MK-7625A) in pediatric participants with nosocomial pneumonia (NP).


Eligibility Criteria:
Inclusion Criteria:

* Is hospitalized and anticipated to receive a minimum of 8 days of concomitant standard-of-care \[SOC\] antibiotic therapy for proven or suspected NP.
* If male, is abstinent from heterosexual intercourse, or agrees to use contraception during the intervention period and for ≥30 days after the last dose of study intervention.
* If female, is not pregnant or breastfeeding, or is not a woman of childbearing potential (WOCBP), or is a WOCBP using acceptable contraception, is a WOCBP with negative urine or serum pregnancy test within 48 hours of the first dose of study intervention, or is abstinent from heterosexual intercourse.

Exclusion Criteria:

* Has a documented history of any moderate or severe hypersensitivity (or allergic) reaction to any β-lactam antibacterial.
* Participants 3 months to \<18 years of age: has moderate to severe impairment of renal function, defined as an estimated creatinine clearance (CrCL) \<50 mL/min/1.73 m2 based on the revised Schwartz equation or requirement for peritoneal dialysis, hemodialysis, or hemofiltration.
* Participants \<3 months of age: has CrCL \<20 mL/min/1.73 m2 based on the revised Schwartz equation or requirement for peritoneal dialysis, hemodialysis, or hemofiltration.
* Is receiving or is anticipated to receive piperacillin/tazobactam while receiving ceftolozane/tazobactam or has received piperacillin/tazobactam within 24 hours prior to the first dose of ceftolozane/tazobactam.
* Has participated in any clinical study of a therapeutic investigational product within 30 days prior to the first dose of ceftolozane/tazobactam.
* Has previous participation in any study of ceftolozane or ceftolozane/tazobactam.
* Has any condition or circumstance that, in the opinion of the investigator, would compromise the safety of the participant or the quality of study data.
* Has any rapidly progressing disease or immediately life-threatening illness including acute hepatic failure or septic shock.
* Has active immunosuppression.