cyrilzakka/clinical-trials huggingface dataset:
Caffeinate Chewing Gum on Ice Hockey Performance

The purpose of this study was to examine the impact of caffeinated chewing gum on the physical performance of elite ice hockey players in a partial sleep deprivation state.

This study used a randomisation crossover design with a single-blind, double-blind experimental design. The participants were randomly assigned to either a caffeinated chewing gum trial (CAF) or a placebo trial (PL).

Eligibility Criteria:
Inclusion Criteria:

* 1. 6 years of professional ice hockey training,
* 2. 6 months of continuous training,
* 3. 3 months of recovery from sports injuries such as strains and sprains

Exclusion Criteria:

* 1. non-specialised ice hockey player.
* 2. has not trained regularly for the past 6 months.
* 3. has recovered from an athletic injury.
* 4. have been recovering from a sports injury for less than 3 months, or have epilepsy, hypertension, hyperlipidemia, heart disease, arthritis, osteoporosis, brain injury, or a history of caffeine allergy.
Monoamine Oxidases in Smoking Pregnant Women and Newborns

Smoking substantially inhibits the activities of both monamine oxidase (MAO) A and B enzymes.

Aims of this study: to compare MAO activities and nicotine and cotinine in peripheral blood of smoking and nonsmoking pregnant women, in their placenta and in cord blood and relate them with the behavior of their newborns being observed during 48 hours after birth.

40 pregnant smoking and 40 pregnant nonsmoking women will be included at the end of the 2nd trimester.

Assessments: smoking characteristics, plasma cotinine, DHPG, DOPAC, 5HIAA concentrations reflecting MAOA activity and platelet MAOB activity will be measured just after inclusion (end of 2nd trimester), just before delivery in venous maternal blood and just after delivery in cord blood.

The newborns' behavior (wellbeing) will be assessed every 8 hour after birth for 2 days.

Comparisons will be made between smoking and nonsmoking women and their newborns.

Eligibility Criteria:
Inclusion Criteria:

* pregnancy of 5 or 6 months
* nonsmokers: lifetime smoking of less than 100 cigarettes; smokers: unable to stop smoking during the first 3 months of pregnancy; smoking at least 10 cigarettes/day.

Exclusion Criteria:

* pathological pregnancies
* opioid dependence; alcoholism.
* chronic psychiatric, hematological, neurological disorders
* eclampsia
* chronic antidepressant or neuroleptic treatment
* current nicotine replacement therapies
A Study to Evaluate the Efficacy and Safety of MLTA3698A in Combination With a Disease-Modifying Anti-Rheumatic Drug (DMARD) Compared With Adalimumab in Combination With a DMARD in Patients With Active Rheumatoid Arthritis

This is a Phase II, randomized, double-blind, placebo-controlled, parallel-group, multicenter study enrolling patients with active rheumatoid arthritis (RA).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of RA according to the 1987 revised ACR Criteria for the Classification of RA for at least 6 months prior to screening
* Positive for rheumatoid factor or anti-cyclic citrullinated peptide (CCP) antibody, or both
* Active disease, defined as: CRP \>= 1.0 mg/dL; swollen joint count \>= 6 (66 joint count); tender joint count \>= 6 (68 joint count)
* Previous inadequate clinical response to at least one disease-modifying anti-rheumatic drug (DMARD) consisting of either methotrexate (MTX) or leflunomide (LFU)
* For patients currently receiving corticosteroids: Treatment at a stable dose during last 4 weeks prior to screening
* For patients currently receiving non-steroidal anti-inflammatory drugs (NSAIDs): Treatment at a stable dose during last 4 weeks prior to screening
* For patients currently receiving sulfasalazine or anti-malarials: Treatment initiated and continued for at least the last 6 months prior to screening and on a stable dose
* For patients of reproductive potential (males and females): Willing to use a highly effective birth control method for the duration of the study according to local guidelines

Exclusion Criteria:

* Pregnant, planning to become pregnant during the study, or breastfeeding
* Clinically significant abnormal laboratory values or abnormal ECG or vital signs
* History of anaphylactic reactions
* Rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA (including but not limited to vasculitis, pulmonary fibrosis, or Felty's syndrome), however patients with secondary Sjogren's syndrome are eligible for the study
* History of or current inflammatory joint disease other than RA (e.g., gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthritis, Lyme disease) or other systemic autoimmune disorder (e.g., systemic lupus erythematosus, inflammatory bowel disease, scleroderma, inflammatory myopathy, mixed connective tissue disease, or other overlap syndrome)
* Current or recent (within 4 weeks prior to screening) infection, including signs, symptoms or serology of any infection, including HIV, hepatitis B or C, tuberculosis
* Administration of a live, attenuated vaccine within 1 month before dosing or anticipation that such a live attenuated vaccine will be required during the study
* Previous treatment with anti-TNF biologics or other biologic agents, including anti-CD20-directed therapy (e.g. rituximab), anti-IL6-directed therapy (e.g. tocilizumab), or T cell-directed therapy (e.g. abatacept)
Long-term Safety Study of Alogliptin Used in Combination With α-glucosidase Inhibitor in Participants With Type 2 Diabetes in Japan

The purpose of this study was to evaluate the long-term safety and efficacy of alogliptin and an α-glucosidase inhibitor administered once daily (QD) or three times daily (TID) for 40 consecutive weeks in participants who completed a phase 2/3 α-glucosidase inhibitor add on study.

Both insulin hyposecretion and insulin-resistance are considered to be involved in the development of type 2 diabetes mellitus.

Takeda is developing SYR-322 (alogliptin) for the improvement of glycemic control in patients with type 2 diabetes mellitus. Alogliptin is an inhibitor of the dipeptidyl peptidase IV (DPP-IV) enzyme. DPP-IV is thought to be primarily responsible for the degradation of 2 peptide hormones released in response to nutrient ingestion. It is expected that inhibition of DPP-IV will improve glycemic control in patients with type 2 diabetes.

"To evaluate the long-term safety and efficacy of alogliptin and an α-glucosidase inhibitor, this extension study was administered for 40 consecutive weeks (52 weeks from the start of treatment in the phase 2 dose-ranging study) to participants who completed a phase 2/3 α-glucosidase inhibitor add on study 322/CCT-003 (NCT01263483).

Eligibility Criteria:
Inclusion Criteria:

* Had completed the phase 2 dose-ranging study (i.e., the subject had completed the study visit at Week 12).

Exclusion Criteria:

* Had clinical manifestations of hepatic impairment (e.g., an aspartate aminotransferase or alanine aminotransferase value 2.5 times or more of the upper reference limit at Week 8 of treatment in the phase 2 dose-ranging study).
* Had clinical manifestations of renal impairment (e.g., a creatinine value of 2 mg/dL or more at Week 8 of treatment in the phase 2 dose-ranging study).
Addressing Mental Health in African American Job Training Adolescents and Young Adults

This project's focus is twofold-to change the culture of an employment training program for adolescents and young adults (Youth Opportunities, or "YO") to more fully address the many mental health issues faced by its participants and to expand and improve the quantity and quality of mental health services for YO members. Four project components have been carefully selected to address the mental health issues of YO members: (1) Mental health education/training for YO staff and peer leaders, (2) Mental health education activities for YO members, (3) mental health screening on all newly enrolling YO members, and (4) comprehensive mental health services for YO members. These project components will be implemented at the HEBCAC YO Program (subsequently referred to as "Eastside" YO), with the Westside YO Program initially participating as a control site. Researchers at the Johns Hopkins University Center for Adolescent Health, led by Dr. Darius Tandon of the Department of Pediatrics, will conduct the research examining the effectiveness of these mental health services and supports.

There are four project objectives. First, the proposed activities will increase YO members' knowledge of mental health resources and decrease stigma associated with seeking mental health services. Second, the investigators will see an increase in YO members' receipt of needed mental health services. Third, the investigators will see improvement in YO members' mental health. Fourth, as a result of their improved mental health, YO members will more actively engage in YO program activities and achieve more key program milestones (e.g., GED completion). These objectives are sequential, with later objectives predicated on the achievement of earlier ones.


Eligibility Criteria:
Inclusion Criteria:

* All newly enrolling Eastside and Westside YO members during the study period will be eligible for study participation.

Exclusion Criteria:

* We will not enroll YO members currently in foster care in this study.
Comparison of Interscalene and Pericapsular Nerve Group (PENG) Block in Shoulder Surgery

Early postoperative pain after shoulder surgery is a major concern and distress for patients and orthopedic surgeons. Adequate pain control; It is vital for all aspects of patient recovery, including mental state, nutrition, cost of care period, rehabilitation, patient satisfaction, and overall post-surgery outcomes.Single analgesic regimens are not always effective in controlling moderate to severe postoperative pain.Therefore, multimodal pain management is preferred and is currently recommended for early postoperative pain control.Regional anesthesia is preferred in shoulder surgery as an effective way to provide anesthesia and postoperative analgesia.To ensure adequate postoperative pain control, nerve supply to the synovium, capsule, joint surfaces, ligaments, periosteum and shoulder muscles must be blocked.Interscalene blocks are well studied and established means of providing analgesia following shoulder surgery and are considered the gold standard mode of regional anesthesia.Pericapsular nerve group block is a new block that provides a pericapsular distribution with local anesthetic infiltration around the glenohumeral joint and provides analgesia without motor blockage by reaching the sensory nerve branches of the glenohumeral joint.The aim of this study was to compare the results between interscalene block and pericapsular nerve group block in patients undergoing shoulder surgery.


Eligibility Criteria:
Inclusion Criteria:

* 18 years and over
* American Society of Anesthesiologists (ASA) 1 and 2
* shoulder surgery

Exclusion Criteria:

* under 18 years old
* American Society of Anesthesiologists (ASA) 3 and above
* who are allergic to local anesthetics
* patients with infection at the injection site
* pregnant women
Montreal Cognitive Assessment Index Following MRI Guided Focused Ultrasound Thalamotomy

We assessed Montreal Cognitive Assessment scores before and after MRI guided focused ultrasound thalamotomy for tremor in order to identify if there are changes in cognitive function following treatment.

All patients who underwent MRI guided focused ultrasound thalamotomy underwent cognitive assessment by Montreal Cognitive Assessment. We calculated the scores before and after treatment and compared the results.

Eligibility Criteria:
Inclusion Criteria:

* Patients that underwent MRI guided focused ultrasound thalamotomy and suffered from Essential tremor.

Exclusion Criteria:

* Patients that did not undergo MRI guided focused ultrasound thalamotomy
* Patinets that did not suffer from Essential tremor.
* Patients that underwent MRI guided focused ultrasound for areas other then a thalamus
* Patients tat underwent bilateral thalamothomy
Study to Compare Resection Versus Preservation of the Middle Turbinate in Surgery for Nasal Polyps

Endoscopic sinus surgery (ESS) has become the standard of care for patients suffering of chronic rhinosinusitis with nasal polyposis (CRSwP) who have failed medical therapy. The goal of surgery is now to widely marsupialize the sinus cavities in order to optimize topical steroid irrigation treatment in the postoperative period. With that being said, the true extent of surgery needed for optimal patient outcome has yet to be elucidated. More specifically, in the last 30 years, people have argued about the best way to manage the middle turbinate. Some state that it should be preserved at all times to protect the sinus cavities from inhaled irritants and allergens and keep this surgical landmark untouched for future surgeries. On the other hand, there are defenders of routine resection of this turbinate, whether it is affected by polypoid changes or not. Many studies have looked at the potential risks of resecting the middle turbinates such as iatrogenic frontal sinusitis, anosmia, or atrophic rhinitis but the more recent literature does not show such significant associations. A recent topic of debate is whether partial removal of the anterior and inferior portion of the middle turbinate affects nasal polyps recurrence or improves long-term outcomes by further facilitation of post-operative topical therapies. Some retrospective data has shown that its resection could prolong the time before the need for revision surgery and improve both endoscopic and olfaction scores. A few prospective studies have also been published but unfortunately none of these were randomized, thus introducing a significant selection bias. Thus, there is a need for a formal randomized, controlled trial to elucidate this question.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of chronic rhinosinusitis with nasal polyposis
* Obtained consent for bilateral complete endoscopic sinus surgery (maxillary antrostomy, complete sphenoethmoidectomy and frontal recess surgery)
* Primary or revision surgery

Exclusion Criteria:

* Allergic fungal sinusitis
* Patients with previous surgery which included partial or complete middle turbinectomy, uni- or bilateral
* Pregnant or lactating women
Feasibility and Safety of Acupuncture for Systemic Lupus

The aim of this pilot study was to evaluate whether acupuncture is safe and acceptable to people with systemic lupus erythematosus (SLE). Twenty-four SLE patients were assigned randomly to receive either 10 sessions of acupuncture, 10 sessions of a minimal-needling control intervention, or their usual medical care alone. It was hypothesized that acupuncture would be safe for people with SLE, and that participants would be able to complete their assigned treatment within 5 to 6 weeks.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed with SLE, 18 years old or older, pain duration at least 3 times per week for at least 3 months, medications and doses stable for the past month, able to speak, read, and understand English, and provide informed consent.

Exclusion Criteria:

* known pregnancy, active uncontrolled organ involvement, steroid dose greater than 10 mg per day, platelets \< 100,000, previous course of acupuncture treatment.
Carbon Dioxide Laser and Cryotherapy in Treatment of Warts

Viral warts are common skin conditions seen in both children and adults. Human papilloma virus is responsible for verrucae. Cutaneous manifestation of the human papillomavirus, are extremely common particularly on the hands and feet. Warts can induce hard, thickened skin, black pinpoints, pain or tenderness with significant morbidity for the patients.

A range of types of wart have been identified, varying in shape and site affected, as well as the type of human papillomavirus involved.

These include:

* Common wart (Verruca vulgaris).
* Flat wart (Verruca plana).
* Filiform or digitate wart.
* Genital wart (venereal wart, Condyloma acuminatum, Verruca acuminata).
* Mosaic wart.
* Periungual wart.
* Plantar wart (verruca, Verruca plantaris). Despite the presence of several therapeutic options, treatment of warts can present a challenge and they are not uniformly effective. Viral warts often disappear without treatment. In case of pain, discomfort and long duration they can be treated . Treatment options include cryotherapy, electrocautery, salicylic acid, immune therapy, minor surgery or laser surgery.

Common warts have a distinctive appearance and can usually be diagnosed with the unaided eye; however, early growth stages and post-treatment warts are less easily diagnosed. Published dermoscopic features of common warts include frogspawn pattern, mosaic pattern and dotted, linear, globular or coiled vessels. Mosaic pattern consists of relatively flattened, rounded structures of similar size, resembling a jigsaw puzzle. Frogspawn pattern consists of densely packed papillae, each containing red dot or loop, surrounded by a whitish halo. Vascular structures seen dermoscopically in common warts as red or black dotted, linear, globular and coiled vessels. Haemorrhages are possible additional features, with black dots corresponding to thrombosed vessels. Hairpin vessels were usually seen in non-wart lesions.

In this study, we aim to compare two therapeutic modalities, the clinical effectiveness and safety of carbon dioxide laser and cryotherapy in the treatment of viral warts together with dermoscopic evaluation of viral warts before and after treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with common warts male or females any age.
2. Patient is able to read and understand English and will give written informed consent to participate.
3. Patient elects to undergo carbon dioxide laser therapy or cryotherapy for treatment of common warts.
4. Warts to be treated will be located only on the hands.

Exclusion Criteria:

1. Non cooperative patients.
2. Patients on other lines of treatment.
3. Pregnant and lactating females.
4. Patients receiving topical treatment in the previous two weeks.
5. Secondary infection.
Ultrasound-guided Thermal Ablation for Recurrent Thyroid Cancer

To evaluate the long-term outcomes of ultrasound-guided thermal ablation for recurrent thyroid cancer

To evaluate and predict the long-term outcomes of ultrasound-guided thermal ablation for recurrent thyroid cancer by a multicenter study

Eligibility Criteria:
Inclusion Criteria:

1. patient received thyroidectomy for thyroid cancer
2. recurrent lesions were pathologically proven to be malignant by core-needle biopsy or fine needle aspiration
3. no evidence of distant metastases.
4. follow-up period ≥12 months

Exclusion Criteria:

1. coagulation disorder, serious heart, respiratory, liver, or renal failure
2. dysfunction of the vocal cord on the opposite side
The Application of the ELFI-TECH Monitor for Perioperative Hemodynamic Measurements

The elfitor device is a small non invasive device that uses dynamic light scattering to measure skin bloodflow, blood velocity, coagulation and hemodynamic parameters. In this study, the investigators will investigate whether the elfitor device is able to detect changes in bloodpressure, cardiac output during general anesthesia. Furthermore, the investigators will investigate changes in cutanuous blood flow in different parts of the body during peripheral nerve or neuraxial block.Being able to monitor these entities, under- and overdosing of general and local anesthetics may be prevented, resulting in favorable hemodynamics and better intra and postoperative pain relieve.


Eligibility Criteria:
Inclusion Criteria:

* any elective surgery under general or neuraxial anesthesia

Exclusion Criteria:

* non elective procedures
Drug-Drug Interaction Study Between CJ-12420 and Clarithromycin in Healthy Male Subjects

Primary Objective: To assess the effect of the coadministration of multiple dose of CJ-12420 and clarithromycin on the pharmacokinetics (PK) of CJ-12420 or clarithromycin.

Secondary Objective(s): To assess the safety of the coadministration of multiple dose of CJ-12420 and clarithromycin in healthy subjects

An open-label, randomized, 6-sequence, 3-period, 3-treatment crossover design

Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers in the age between 19 and 45 years old
* Body mass index(BMI) in the range of 19 to 28 kg/m2
* Understand the requirement of the study and voluntarily consent to paticipate in the study

Exclusion Criteria:

* History of clinically significant medical history or disease (hepatic, kidney, gastrointestinal,respiratory, musculoskeletal, endocrine,neuro-psychiatric, haemato-oncologic,urinary tract, cardiac arrhythmia and cardiovascular system) judged by investigator.
* Clinically significant abnormal laboratory results within at least 28 days prior to the first day of drug administration. AST or ALT \> 1.25 times of upper limit value Total bilirubin \> 1.5 times of upper limit value estimated GFR :less than 80 mL/min
* Clinically significant abnormal ECG results within at least 28 days prior to the first day of drug administration PR ≥ 210 msec QRS ≥ 120 msec QT ≥ 500 msec QTcF ≥ 500 msec
* Clinically significant hypersensitivity reaction against investigational drug or other drugs
* history of drug abuse or "positive" results from drug screening test.
* Take medicine such as prescription medicine or herbal medicine, over-the-counter drug, vitamin supplements
* Person who have intake history of food or drug which can affect drug absorption, drug distribution, drug metabolism, and drug excretion and bowel activity
* Volunteer have a history of donation of whole blood donation, apheresis, transfusion
* Volunteer a heavy drinker(30g/day), smoker(10 cigarettes/day), heavy caffeine consumer(400mg/day)
Genetics of Appendix Cancer Study

The GAP Study is a prospective cohort study designed to comprehensively investigate genetic variations that may contribute to cancer development among individuals diagnosed with appendix/appendiceal cancer who are ages 18+ years.

The Genetics of Appendix Cancer (GAP) Study aims to analyze hereditary factors, tumor characteristics and clinical features/outcomes among adults diagnosed with appendix cancer and their biological parents. Patients are recruited at any time after a diagnosis of appendix cancer and followed for up to 6 years after study enrollment. This cohort is enriched by robust biospecimens and data collections.

Eligibility Criteria:
Inclusion Criteria:

GAP Social

* Known diagnosis of appendix cancer in the United States
* Mentally and physically able to consent and participate in the study

GAP Vanderbilt

* Known diagnosis of appendix cancer
* Diagnosed by and/or consulting with a physician/clinical provider participating in the GAP Study
* Mentally and physically able to consent and participate in the study

GAP Parent

* Biological parents (mother and/or father) of individuals actively participating in the GAP Study
* Residing in the United States
* Mentally and physically able to consent and participate in the study

Exclusion Criteria:

* Women pregnant at the time of consent
* Prisoners
* Unable to provide informed consent
* Unable to read, write, or complete questionnaires in English