cyrilzakka/clinical-trials huggingface dataset:
A Single Dose Study Investigating the Absorption and Elimination as Well as the Tolerability of Varenicline Transdermal Delivery System (e.g., a Patch) as Compared to Oral Varenicline in Adult Smokers.

1. To evaluate the absorption and elimination of varenicline Formulation A transdermal delivery system \[TDS (patch)\] compared to varenicline immediate release tablet (CHANTIX®).
2. To evaluate the adhesion of the varenicline Formulation A patch.
3. To evaluate the safety and tolerability of a single application of the varenicline patch and a single oral dose of the varenicline immediate release tablet (CHANTIX®).


Eligibility Criteria:
Inclusion Criteria:

* healthy adult smokers

Exclusion Criteria:

* Significant blood, kidney, lung, gastrointestinal, heart, liver, psychiatric, or neurologic disease
* Illegal drug usage
Provision of Breakfast Food in Behavioral Weight Loss

A contributing factor to the rising prevalence of obesity may be increased portion sizes. However, the effect of portion size has not been studied independent of the effect of quantity of food in the context of a behavioral weight loss program. Providing pre-portioned single servings of food may make it easier to reduce caloric and dietary fat intake improving weight loss. In addition, breakfast skipping is associated with obesity and breakfast consumption is associated with weight loss success. Therefore, the objective of the proposed study is to investigate the effect of portion size on consumption of provided breakfast foods in the context of a behavioral weight loss program. Participants will be randomized to 1 of 2 standard 12-week behavioral obesity interventions. The first intervention, serving as a control, will provide participants with breakfast foods in non-portioned containers (Standard). A second intervention will provide participants with the same type and quantity of breakfast foods but they will be provided in pre-portioned single servings (Portion). Dependent variables include the number of calories consumed from the provided foods as well as overall caloric and fat consumption. If the provision of food in pre-portioned servings is effective at decreasing intake, future directions include conducting longer interventions to improve long-term weight loss outcomes in standard behavioral interventions.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 21 and 65 years. Older adults may have more medical co-morbidities and may require greater medical supervision.
2. Body mass index (BMI) between 25 and 40 kg/m2. Based upon the Evidence Report (National Heart, Lung, and Blood Institute \[NHLBI\], 1998), weight loss is recommended for individuals with a BMI \> 25. However, individuals with a BMI of \> 40 have more medical co-morbidities and require greater medical supervision.
3. Average current consumption of breakfast on four days or fewer.

Exclusion Criteria:

1. Report allergies to any of the foods provided in the treatment or report lactose intolerance due to the high lactose content of some of the foods provided.
2. Report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR-Q) (Thomas, Reading, \& Shephard, 1992). Individuals endorsing joint problems, prescription medication usage, or other medical conditions that could limit exercise will be required to obtain written physician consent to participate.
3. Report major psychiatric diseases or organic brain syndromes.
4. Are currently participating in a weight loss program and/or taking weight loss medication or lost \> 5% of body weight during the past 6 months.
5. Intend to move to another city within the time frame of the investigation or will be out of town and unavailable for meetings for more than one week during the treatment program.
6. Are pregnant, lactating, less than 6 months post-partum, or plan to become pregnant during the time frame of the investigation.
Is a Low Thyreotropin Level Predictive of Recurrent Arrhythmia After Catheter Ablative Surgery?

Overt hyperthyroidism (so-called "goiter" in lay language) is a hormonal disturbance that is known to increase the risk of atrial fibrillation (a common heart arrhythmia with potentially severe consequences) in some patients. Previous research has indicated that even slight elevations in thyroid hormone levels - so called subclinical hyperthyroidism - may increase this risk. When atrial fibrillation and overt hyperthyroidism are found simultaneously in a patient, the hormonal imbalance must be treated first in order to later resolve the arrhythmia. It is unclear whether this strategy holds true for subclinical hyperthyroidism. Our two hypotheses are: 1) Subclinical hyperthyroidism is more prevalent in patients admitted for atrial fibrillation ablation than in the population as a whole, and 2) Patients with subclinical hyperthyroidism and atrial fibrillation benefit less from ablation than others.

As a control group, we have chosen patients admitted for ablation of AV-nodal Reentry Tachycardia at the same clinics as the cases. No correlation has ever been shown between AV-nodal Reentry Tachycardia and hyperthyroidism.


Eligibility Criteria:
Inclusion Criteria:

* Atrial fibrillation or AV-nodal reentry tachycardia
* Fulfills criteria for ablation (severe arrhythmia symptoms; for atrial fibrillation patients, having tried at least one antiarrhythmic agent with poor effect)
* Admitted for ablation for the first time
* Has left blood samples for thyroid status (TSH, free T4, free T3)

Exclusion Criteria:

* Atrial flutter
* Overt hyperthyroidism
Clinical Effect of Caffeine Consumption in Patients Taking Oral Terbinafine

The investigators hypothesize that there would be significant changes in blood pressure or heart rate in patients consuming caffeine while taking terbinafine.

Terbinafine is a common oral medication used for moderate to severe nail onychomycosis. On the terbinafine package insert, it states that terbinafine can reduce clearance of caffeine by 19%. However, the clinical effects of this finding in patients have yet to really be studied. Decreased clearance of caffeine can physically present with measurable signs such as an increased blood pressure or increased heart rate, as well as less measurable symptoms of GI upset, irritability, headache, insomnia. As a result, dermatologists do not always know how to counsel patients taking terbinafine on their caffeine intake. Hence, recommendations vary as no studies have been done on whether caffeine consumption while taking terbinafine is associated with clinical outcomes, such as measurable changes in blood pressure or heart rate.

This will be a preliminary single-blind randomized control clinical study. Patients being started on oral terbinafine by video visit will be approached for enrollment in the study. Patients will be provided with the baseline survey, to assess demographic information, BMI, and daily caffeine intake. Patients with a history of hypertension and anxiety will not be enrolled per the exclusion criteria. If the patient's blood pressure or heart rate are abnormal, they will be removed from the study

We hypothesize that there would be significant changes in blood pressure or heart rate in patients consuming caffeine while taking terbinafine.

Eligibility Criteria:
Inclusion Criteria:

* Patient of any gender at least 18 years of age
* Diagnosed with onychomycosis
* Planning to start oral terbinafine

Exclusion Criteria:

* Pregnant or breastfeeding
* Any history of anxiety or hypertension
* Any patient with an inability to give consent
Injectable Platelet Rich Fibrin With Non Surgical Periodontal Therapy

Clinical evaluation of local subgingival application of injectable platelet-rich fibrin ( i-PRF ) for chronic periodntitis as adjunctive to non surgical therapy and compare it with hyaluronic acid.

120 periodontal patients will receive a scaling and root planing ( non surgical periodontal therapy). Equal number of patients will receive subgingival application of i-PRF, hyaluronic acid or placebo gel as the adjunction to non surgical therapy.

The aim of the study is to evaluate and compare the clinical efficacy of subgingival application of i-PRF and hyaluronic acid gel as adjunctive to non-surgical periodontal therapy. 120 periodontal patients will receive traditional mechanical supra and subgingival scaling and root planing. Patients were randomly allocated in three groups. Group 1, 2 and 3 will receive subginigval application of placebo, hyaluronic acid gel and i prf respectively. Clinical parameters will be evaluated: plaque index (PI), gingival index (GI), bleeding on probing (BOP), probing depth (PD), clinical attachment level (CAL), gingival recession (GR). Clinical measurements will be performed at baseline, 1 month and at 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients are in general good health.
* Patients having minimum of 20 permanent teeth.
* They have not taken medication known to interfere with periodontal tissue health or healing in the preceding 6 months.
* Presence of periodontal pockets (≥5 mm) and clinicala ttachment level \> 5 mm.

Exclusion Criteria:

* Immunosuppressive systemic diseases (like cancer, AIDS, diabetes etc.)
* Clotting and Hematological disorders
* Patients with grade III mobility.
* Patients with smoking and alcohol consuming habit.
* Pregnant and lactating female.
* Medications influence on the gingival and periodontal tissues (like calcium channel blockers, or Long-term steroid use)
* The teeth with poor filling and ill fitted restorations
Computer Guided Buccal Cortical Plate Separation for Removal of Calcified Benign Odontogenic Tumors Affecting Mandibular Angle Region

Computer guided buccal cortical plate separation was performed for ten patients using patient specific osteotomy locating guides and pre-bent plates. The guide was designed to outline the osteotomy, buccal cortical plate was separated, the lesion was removed, finally the pre-bent plates were used to fix the separated cortex.

Computer guided buccal cortical plate separation was performed for ten patients using patient specific osteotomy locating guides and pre-bent plates. The guide was designed to outline the osteotomy, buccal cortical plate was separated, the lesion was removed, finally the pre-bent plates were used to fix the separated cortex.

Eligibility Criteria:
Inclusion Criteria:

* Patients with well-defined radiopaque lesion affecting angle region, its conventional removal may compromise the bone continuity and leads to pathological fracture indicating the need of buccal cortical plate separation technique

Exclusion Criteria:

* Patients with any medical condition contraindicating the surgical procedures were excluded
Magnetoencephalography by Optical Pumping Magnetometer

MagnetoEncephaloGraphy (MEG) is a method of recording brain activity with high temporal resolution and good spatial resolution, compared to current recording techniques such as ElectroEncephaloGraphy (EEG). The main limitation of MEG is its cost due to the sensors used, the Super Quantum Interference Devices (SQUID). These require a complex infrastructure from an instrumentation point of view to operate, requiring liquid helium, most often at a loss, at increasing cost. Optical Pumping Magnetometers (OPM) type sensors represent a promising alternative to SQUIDs sensors, especially since they do not require helium cooling.

The purpose of this project is to Identify biomarkers in Magnetoencephalography of normal brain development in healthy adults, premature and term newborns from "a priori" obtained by the classical technique of High Resolution EEG performed.


Eligibility Criteria:
Inclusion Criteria:

* For healthy adult volunteers
* Age between 18 and 65
* No pathology, no treatment
* No toxicant intake
* For term newborns
* Child between 38 and 42 weeks gestational age on the day of registration
* No pathology, no treatment
* For children born prematurely
* Child between 28 and 36 weeks gestational age on the day of registration
* No pathology, no treatment apart from routine care related to prematurity
* For pregnant women
* Pregnant with between 28 to 40 weeks gestational age on the day of registration
* No pathology, no treatment

Exclusion Criteria:

* Subject and Patients "not compatible" MEG. Wearers of prosthesis or pacemaker likely to generate artefacts interfering with the measurement. There is no danger to the subject, but the measurement itself may be impossible.
* Patients who cannot stand to stand still for a few minutes.
* Newborn on ventilatory assistance or infusion
* Newborn baby not meeting the age criteria
Wound Bed Preparation for Diabetic Foot Ulcers

The study objective was to compare the efficacy of NPWT versus alginates dressings on the wound bed preparation prior to STSG surgery, as well as investigating the underlying mechanisms.

The diabetic foot ulcers (DFUs) are major complications of patients with diabetes mellitus. Split thickness skin graft (STSG) surgery is a cost-effective method for the rapid healing of DFUs. The aim of this study was to compare the efficacy of negative pressure wound therapy (NPWT) using vacuum-assisted closure (VAC) device versus conventional moist dressings (alginates) on the wound bed preparation prior to STSG surgery for patients with chronic DFUs.

This ia a prospective, randomized controlled trial. All the patients were randomly divided into two groups: the NPWT group or the control group. Once the DFUs wound was filled with healthy granulation tissues, STSG surgery was performed. The primary endpoint included the time to STSG surgery (the duration from first surgical debridement to STSG surgery). The secondary endpoints included the survival rates of skin graft, the wound blood perfusion, the wound neutrophil extracellular traps (NETs) formation, and polarization of M1 or M2 macrophages in the DFUs wounds of the two groups.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with DFUs aged 20-80 years.
2. Wagner grade 2 to 3.
3. Chronic DFUs wounds (duration of disease ≥ 2 weeks).
4. Ankle brachial ratio (ABI) 0.5～0.9, wound area 8\~20 cm2.

Exclusion Criteria:

1. Patients who were unable to complete the follow-up were not included,
2. Pregnant or nursing mothers were not included.
3. Patients with foot ulcers other than diabetes, peripheral vascular disease, organ dysfunctions (heart failure, respiratory failure, liver dysfunction, renal impairment or intestinal failure), or autoimmune diseases (rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematosus, Sjogren's syndrome, connective tissues disease or systemic vasculitis) were not included.
4. Patients who received growth factors or hyperbaric oxygen therapies for the DFUs wounds within one month were not included.
5. Patients who had medications (such as corticosteroids, immunosuppressive agents or chemotherapy) within six months were not included.
Peri-Articular-Multimodal Drug and Oral Celecoxib in Management of Postoperative Pain of Total Knee Arthroplasty

This study is a randomized-clinical-trial on 146 patients candidate for total knee arthroplasty (TKA) who were randomly allocated to three treatment groups, including 1) a cocktail consisting of bupivacaine, morphine, epinephrine, and ketorolac (n=48), 2) only epinephrine (placebo group) (n=49), and 3) 400mg celecoxib orally (control group) (n=49) using Random Allocation software. The injections and oral therapy were performed within 15 minutes before the surgical procedure. The study's primary outcome was the Knee Society Score (KSS) calculated at baseline, within six weeks and six months postoperatively. Range of motion (ROM) and Visual Analogue Scale (VAS) to assess pain intensity as the other primary outcomes were evaluated before the procedure, within 24 hours, 48 hours, and six weeks postoperatively.

This randomized clinical trial conducted on 146 patients undergone TKA in orthopedic hospitals affiliated at Isfahan University of Medical Science (IUMS) in 2021.

The presence of osteoarthritis, making the patients candidate for primary unilateral total knee arthroplasty (TKA), and body mass index of 20-30 kg/m2 were determined as inclusion criteria.

The Regional Bioethics Committee of IUMS approved the study protocol. This study was designed as a census study; therefore, all the patients who met the criteria for participation in this study were recruited. Participants were randomly divided into three groups using Random Allocation software, so each patient was provided with a specific number from 1-to-146 by the software and allocated to one of the groups.

The investigator who performed the baseline and follow-up assessments and the patients were unaware of the study group; as the investigator was absent at the time of the surgery and all the patients administered a pill prior to the surgical procedure (one group was treated with celecoxib and the other two ones administered placebo similar in shape and color with celecoxib).

The primary outcome was the Knee Society Score (KSS) calculated at baseline, within six weeks and six months postoperatively. Range of motion (ROM) and Visual Analogue Scale (VAS) to assess pain intensity as the other primary outcomes were evaluated before the procedure, within 24 hours, 48 hours, and six weeks postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of osteoarthritis
* Candidate for primary unilateral TKA
* Body mass index of 20-30 kg/m2

Exclusion Criteria:

* Unable to follow-up the assessments
* Having more than 20% defects in medical records
Encapsulated Cell Biodelivery of Nerve Growth Factor to Alzheimer´s Disease Patients

Cholinergic neurons in the basal forebrain project widely to the cerebral cortex and hippocampus. These neurons depend on nerve growth factor (NGF) from their target areas for survival. Impaired NGF supply is part of the Alzheimer's disease (AD) pathology, and the degeneration of these neurons correlates with the cognitive decline in these patients. The objective of encapsulated cell biodelivery (ECB) is to maintain normal levels of NGF to support cholinergic function. NsGene's NGF secreting ECB device (NsG0202) combines the potential benefits of targeted gene therapy with the safety of a retrievable implantable device.

The study is an open label, single centre, 12-month, dose-escalation phase Ib study in patients with mild to moderate AD. The primary objective is safety and tolerability, while secondary outcomes measure include cognition, behaviour, neuropsychology, activities of daily living (ADL), positron emission tomography (PET) imaging and electroencephalography (EEG).


Eligibility Criteria:
Inclusion Criteria:

1. Age 50-80 years
2. All patients must fulfil the NINDNDS-ARDRA criteria of Alzheimer's disease.
3. The subject must have a score between 15-24 inclusive, on the mini-mental state examination (MMSE).
4. The subject must have a caregiver who is able and committed to assist the subject to comply with the trial protocol, and who is willing to provide the information required at assessment interviews.
5. Informed consent must be obtained from the subject together with a close caregiver, in accordance with the requirements of the ethical committee.

Exclusion Criteria:

1. A diagnosis of Schizophrenia, Schizo-affective disorder or paranoid disorder according to DSM IV without any suspicion cognitive decline.
2. Patients with the following co-existing medical conditions:
3. History of seizures.
4. Brain tumor including meningeoma.
5. Clinically significant hepatic, renal, pulmonary, metabolic or endocrine disturbances.
6. Clinically significant back pain.
7. Bleeding disorders.
8. Patients who, in the opinion of the investigator, are otherwise unsuitable for a trial of this type.
A Research Study of NNC0165-1875 Alone or Together With Semaglutide in People Who Are Overweight or Obese

The study is looking at possible new medicines for weight control in people with high body weight. The study looks at how the new medicines work in the body. The study consists of two parts. If participants take part in Part 1, they will either get a single dose of NNC0165-1875 or a "dummy" medicine (placebo). If participants take part in Part 2, they will either get a single dose of NNC0165-1875 or "dummy" medicine and also a single dose of semaglutide. Which treatment participants get is decided by chance. For Part 1 participants will get 1 injection. For Part 2 participants will get 2 injections. A study nurse at the clinic will inject the medicine with a thin needle in a skin fold in the stomach. The study will last for about 9 weeks. Participants will have 7 visits to the clinic with the study doctor.


Eligibility Criteria:
Inclusion Criteria:

* Males, aged 18-55 years (both inclusive) at the time of signing informed consent
* Body mass index (BMI) between 25.0 and 34.9 kg/m\^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator
* Body weight greater than or equal to 70 kg

Exclusion Criteria:

- Male of reproductive age who or whose partner(s) is not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice)
Efficacy and Safety of Cyclosporine Microemulsion in Diabetic Adult Stable Liver Transplant Recipients

The purpose of this study is to determine whether the switch from tacrolimus to cyclosporine microemulsion benefits post-transplant diabetes management (in terms of glycogenic control and insulin dosage) in stable liver transplant recipients.


Eligibility Criteria:
Inclusion Criteria:

* At least 4 months post-transplant
* Patients in treatment with tacrolimus
* Post-transplant diabetes treated with insulin for at least one month

Exclusion Criteria

* Known hypersensitivity to cyclosporine microemulsion
* Investigational drug within 60 days before baseline or during the study
* Patients who cannot comply with the study requirements

Other protocol-defined exclusion criteria applied