cyrilzakka/clinical-trials huggingface dataset:
Dry Cupping for Recovery From Muscle Damage

This study compares the effect of dry cupping to placebo cupping after muscle-damaging exercise on recovery of muscle strength, muscle swelling, and muscle soreness.

Dry cupping is a technique where cups are placed on the skin and a suction device is used to remove air from the cups. This study aims to investigate whether dry cupping therapy can enhance muscle recovery following exercise by measuring muscle soreness, swelling, and strength in the biceps. Six sets of biceps curls (emphasizing concentric and eccentric overload) will be performed on each arm, followed by dry cupping with suction applied to one arm (experimental) and dry cupping without suction (placebo) applied to the opposite arm. Experimental and placebo arms for each participant will be randomized. Before exercise and immediately, 24 hours, 48 hours, and 72 hours after exercise, muscle strength, muscle swelling (ultrasound), and muscle soreness (visual analog scale) will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Male or female
* 18-35 years old
* Experienced with upper arm resistance training for at least 3 months

Exclusion Criteria:

* Conditions that might make exercise dangerous (determined by "yes" answers to the "Get Active Questionnaire")
* Open wounds, scars, eczema, or other skin sensitivities on the biceps area
Partnership Optimizes Weight Management in Primary Care

The purpose of this study is to examine whether a primary care weight management intervention delivered by peer coaches produces greater weight loss than a self-directed program without peer coach support.


Eligibility Criteria:
Inclusion Criteria:

* Age 21-75 years
* Body mass index (BMI) 30-50 kg/m2
* Receiving primary care services at one of the practices participating in this study

Exclusion Criteria:

* Uncontrolled hypertension (blood pressure \>160/100 mm Hg at screening)
* Any of the following other medical conditions: myocardial infarction or cerebrovascular accident within the last six months; unstable angina within the past six months; NYHA Class III or IV congestive heart failure; type 1 diabetes; cancer requiring treatment in past five years (exception: non-melanoma skin cancer); and chronic lung diseases that limit physical activity
* Current use of any of the following medications: antipsychotic agents, monoamine oxidase inhibitors, systemic corticosteroids, or chemotherapeutic drugs; prescription weight loss medications (past six months)
* Unwilling or unable to do any of the following: give informed consent; read/understand English; accept random assignment; travel to the intervention site
* Likely to relocate out of the area in the next 2 years
* Participation in another randomized research project
* Weight loss \> 10 pounds in past six months
* History of bariatric surgery
SpaceOAR System Pivotal Study

Evaluate the safety of the SpaceOAR System when the hydrogel is injected between the rectum and prostate in men undergoing radiation therapy (IG-IMRT)

The purpose of this study is to evaluate the safety of the SpaceOAR System when the hydrogel is injected between the rectum and prostate in men undergoing radiation therapy (IG-IMRT) and to evaluate whether use of the SpaceOAR hydrogel results in a reduction of radiation exposure to the anterior rectum.

Eligibility Criteria:
Inclusion Criteria:

* Subjects greater than 18 years old
* Subjects must have pathologically confirmed invasive adenocarcinoma of the prostate and must be planning to undergo IMRT
* Subjects must have clinical stage T1 or T2 as determined from a biopsy taken within 6 months of the baseline/screening visit with Gleason Score less than or equal to 7
* Subjects Screening/Baseline laboratory testing must meet the following laboratory value criteria: PSA less than or equal to 20 ng/mL,hematocrit greater than 30%,serum creatinine less than 2.0 mg/dl, serum AST and ALT less than 2.5 times upper limit of institution normal, and serum bilirubin less than 2.0 mg/dl
* Subject or authorized representative, has been informed of the nature of the study and has provided written informed consent, approved by the appropriate Institutional Review Board (IRB) of the respective clinical site

Exclusion Criteria:

* Prostate greater than 80cc documented within 3 months preceding the Screening/Baseline visit
* Subjects with extracapsular extension of the prostate cancer, with greater than 50% of the number of biopsy cores positive for cancer, metastatic disease, other ongoing cancers which will be treated during the study, or subjects for whom pelvic lymph node radiotherapy is planned
* Subjects with any prior invasive malignancy (except non-melanomatous skin cancer) unless the subject has been disease free for a minimum of 5 years.
* Subjects who are indicated for androgen deprivation therapy or who have been treated with androgen therapy within the prior 3 months.
Utility of Thermal Imaging in Diagnosis of Cellulitis for Lower Extremity Complaints in the Emergency Department

The overall purpose of the study is to determine how providing physicians with a quantitative measure of skin surface temperature influences diagnoses and diagnostic confidence in potential cellulitis cases when added to the standard evaluation.

Previous literature estimates the emergency department misdiagnosis rate for cellulitis exceeds 30% due to conditions which can mimic cellulitis (termed pseudocellulitis). These diagnostic errors are associated with an estimated $195 to $515 million dollars in avoidable healthcare spending each year. Objective skin surface temperature measurement, obtained via thermal imaging cameras, has been proposed as a diagnostic adjunct that may reduce diagnostic error in cases of suspected cellulitis. One recent study, identified that the maximum affected skin temperature in cellulitis is significantly higher than in pseudocellulitis, and the temperature gradient between affected and unaffected sites in patients with cellulitis is significantly higher than in patients with pseudocellulitis.

The overall purpose of the study is to determine how providing physicians with a quantifiable measure of skin surface temperature information influences diagnoses and diagnostic confidence in potential cellulitis cases when added to standard physical exam techniques

The Aims of the study are to :

Specific Aim 1: To characterize the temperature difference between affected and unaffected limbs in patients with cellulitis in the emergency department.

Specific Aim 2: To characterize the temperature difference between cases of cellulitis and pseudocellulitis

Specific Aim 3: To determine how quantifying temperature gradients changes diagnostic confidence and accuracy when added to the standard diagnostic evaluation for potential cellulitis.

The investigators will prospectively enroll a maximum of 560 patients with non-traumatic lower extremity dermatologic complaints with visible erythema (potential cellulitis) in the University of Wisconsin Emergency Department. A thermal image and a photograph of the affected and the unaffected limbs will be taken.

Eligibility Criteria:
Inclusion Criteria:

* Participant is presenting to the University of Wisconsin Emergency Department
* Participant has an acute skin complaint on the lower extremity

Exclusion Criteria:

* Participant is has limited English and Spanish proficiency
* There was an acute traumatic injury of affected area in last 5 days- includes burns
* Affected area has a confirmed fracture
* Participant is pregnant
* Participant is a prisoner
* Current complaint is in an area of past surgical procedure (within past 4 weeks)
* Participant has implant or hardware at site
* Animal or human bite is cause of complaint
* Temperature of the leg has been altered in the last one hour
* Unable to provide informed consent
Safety and the Pharmacokinetic Study of Characteristics of MKT-N2 (Montelukast) and Singulair® (Montelukast Sodium)to Treat Asthma

The Purpose of A center, Randomized, Open label, single dose, Placebo-controlled, 2-Treatment, 2-Way, 2-Period Crossover Study to Compare the Safety and the Pharmacokinetic Characteristics of MKT-N2 (Montelukast) and Singulair® (montelukast sodium) tablet 10mg in Healthy Male Korean Subjects


Eligibility Criteria:
Inclusion Criteria:

* Healthy Korean Male over20, under 45 years old
* 55kg over weight, IBW +-20% range male

Exclusion Criteria:

* Males who have gotten a clinically significant of liver, pancreas, kidneys, nervous system, respiratory system, endocrine system, blood cancer, mental illness, cardiovascular, urinary tract disease, or a history corresponding
* Males who have gotten a history of gastrointestinal disease
* Males who have gotten a history of hypersensitivity to montelukast or reaction to other drugs(aspirin, antibiotics)
To Evaluate an MRI-based Optimized Prostate Cancer Diagnostic Pathway Powered by Artificial Intelligence

It is a prospective paired-cohort study for diagnostic test evaluation. The study aim to determine the accuracy of AI review and investigate whether AI review could detect MRI visible significant cancer as effective as radiologist review. MRI image of about 368 men recommended for biopsy will be reviewed by an AI model and an experienced radiologist, respectively. AI review (index) and radiologist review (standard) will be blinded to each other, while biopsy urologists will be well-informed of the findings of both AI review and radiologist review and make personalized biopsy plan by combining both findings. The pathological results of MRI-ultrasound fusion biopsy (reference) will serve as the gold standard to assess the diagnostic accuracy.

ProstateAI is a prospective paired-cohort study for diagnostic test evaluation. ProstateAI will determine the accuracy of AI review and investigate whether AI review could detect MRI visible significant cancer as effective as radiologist review. MRI image of about 368 men recommended for biopsy will be reviewed by an AI model and an experienced radiologist, respectively. AI review (index) and radiologist review (standard) will be blinded to each other, while biopsy urologists will be well-informed of the findings of both AI review and radiologist review and make personalized biopsy plan by combining both findings. The pathological results of MRI-ultrasound fusion biopsy (reference) will serve as the gold standard to assess the diagnostic accuracy.

Eligibility Criteria:
Inclusion Criteria:

* Patients recommended for prostate biopsy for diagnosis or re-assessment.
* Men at least 18 years or over
* Patients with prostate MRI image eligible for radiologist review and AI review.
* Patient Informed Consent is signed.

Exclusion Criteria:

* Patient contraindicated to prostate biopsy
* Patient failed to complete the biopsy procedure
The Nephroprotective Effect of Metformin With Cisplatin in Bladder Cancer

The goal of this clinical trial is to evaluate the protective effect of metformin on nephrotoxicity of cisplatin in patients with bladder cancer. The main questions it aims to answer are:

* To determine protective effect of metformin on structural and functional kidney injury caused by cisplatin in patients with bladder cancer.
* To evaluate the safety of combining cisplatin and metformin on patients with bladder cancer


Eligibility Criteria:
Inclusion Criteria:

1. Non-diabetic adults of age between 18 to 65.
2. Chemotherapy naïve patients diagnosed with bladder cancer.
3. Patients with stable renal function: eGFR is above 60 ml/min/1.73 m2

Exclusion Criteria:

1. Patients with history of lactic acidosis.
2. Patients taking any nephrotoxic medication other than cisplatin (e.g., frusemide, NSAIDs, aminoglycoside or vancomycin).
3. Unstable renal function (defined as an increase in serum creatinine of 0.3 mg/dL or greater suddenly in 48 hours according to the acute kidney injury network (AKIN) classification
4. Patients with heart failure, acute myocardial infarction or cardiogenic collapse (shock).
5. Severe infection and sepsis.

   * Any infection requiring hospitalization.
   * Any infection leading to a need for oxygen, intubation, vasopressors or fluids to support blood pressure.
6. Alcohol intake.
7. Respiratory failure.
8. Severe hepatic impairment (Child-Pugh class C).
9. Patients with metastasis.
A Treatment Study Comparing Two Non-Drug, Self-Help Treatment of Chronic Insomnia.

The purpose of this study is to determine whether a handheld computer is superior to a self-help manual for the treatment of chronic primary insomnia.

Chronic primary insomnia is a highly prevalent condition, affecting up to 15% of the population. The condition is associated with daytime fatigue, lack of concentration, and decreased quality of life. Most people with chronic primary insomnia go untreated, because of a desire to avoid medication or lack of access to quality non-drug treatments. Therefore, an affordable, easy to use, and effective computer to help assess and treat insomnia symptoms could bring treatment to this population.

Comparison: We are comparing a new handheld computer that uses cognitive-behavioral treatment principles to a popular self-help manual for the treatment of primary insomnia symptoms.

Eligibility Criteria:
Inclusion Criteria:

* sleep less than 6.5 hours per night
* at least 30 minutes of sleep onset latency or wakefulness after sleep onset
* symptoms present for at least 6 months
* must have insomnia symptoms at least 3 days per week

Exclusion Criteria:

* Body Mass Index greater than 32
* Presence of anxiety disorder
* Secondary forms of insomnia
* Presence of a substance use disorder
* Concurrent treatment for another mental disorder
* History of other sleep disorders, including: apnea, restless legs, periodic limb movement disorder, or narcolepsy
CALM Phase 2b Pilot

Managing Cancer And Living Meaningfully (CALM) is a brief psychotherapy designed to alleviate distress in advanced cancer. In an earlier intervention-only pilot trial, CALM was associated with reductions in depressive symptoms and death anxiety and an increase in spiritual wellbeing. The purpose of this study is to assess the feasibility of a large-scale randomized controlled trial (RCT) of CALM and to identify preliminary effects in advanced cancer. This phase 2b pilot RCT employed intervention and usual care arms with 3 and 6 month follow-ups. The primary outcome was depressive symptoms (PHQ-9) and secondary outcomes included diagnosis of major depression (SCID), death anxiety, attachment security and spiritual wellbeing. Multilevel regression was used to compare change over time between groups. 60 patients with advanced cancer will be recruited from the Princess Margaret Cancer Centre, Toronto, Canada, and equally randomized into intervention and usual care conditions.

Abstract

Background Managing Cancer And Living Meaningfully (CALM) is a brief individual psychotherapy for patients with advanced cancer. In an intervention-only phase 2a trial, CALM showed promising results, leading to the present 2b pilot, which introduces procedures for randomisation and improved rigour in preparation for a phase 3 randomised controlled trial (RCT).

Aims To test trial methodology and assess feasibility of a confirmatory RCT.

Design A parallel-arm RCT (intervention vs usual care) with 3 and 6-month follow-ups. Assessment of feasibility included rates of consent, randomisation, attrition, intervention non-compliance and usual care contamination. Primary outcome: depressive symptoms (Patient Health Questionnaire-9; PHQ-9). Secondary outcomes: major depressive disorder (MDD), generalised anxiety, death anxiety, spiritual well-being, attachment anxiety and avoidance, self-esteem, experiential avoidance, quality of life and post-traumatic growth. Bayesian conjugate analysis was used in this low-powered setting.

Setting/participants 60 adult patients with advanced cancer from the Princess Margaret Cancer Centre.

Trial registration number NCT02353546.

http://dx.doi.org/10.1136/bmjspcare-2015-000866

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Fluent in English
* Confirmed diagnosis of Stage IIIB or IV lung cancer, Stage III or IV ovarian cancer, Stage IV endocrine, breast, gastrointestinal, genitourinary or gynecologic cancer, or pancreatic cancer at any stage

Exclusion Criteria:

* Short Orientation-Memory-Concentration Test (score of \<20)
* Individuals receiving in-hospital psychiatric or psychological treatment at the time of recruitment
Clinical Feasibility of New Tracheoesophageal Puncture Set

During a total laryngectomy a puncture is created in the tracheoesophageal wall and a voice prosthesis is inserted. With this voice prosthesis the patient learns to speak again. During this study a new surgical tool will be investigated that creates the puncture and places the voice prosthesis.


Eligibility Criteria:
Inclusion Criteria:

* primary puncture during total laryngectomy
* secondary puncture some time after total laryngectomy

Exclusion Criteria:

* anatomical abnormalities that prevent appropriate pharynx protection during secondary puncture
* not eligible to use a voice prosthesis for other reasons
Effects of Local Vibrations Program of Dorsiflexor Muscles on Neuromotor Recovery in Subacute Stroke Patients.

The aim of the vibration intervention proposed in the current study is to allow a better neuromotor recovery in subacute stroke patients when compared with standard rehabilitation alone. These last years, it has been proven that the solicitation of a muscle using vibrations may lead to positive effects on the neuromuscular function. Thus, the aim of the current study is to assess if the addition to a standard rehabilitation program of local vibrations sessions of the dorsiflexor muscles of the paretic limb of stroke patients may allow a better recovery of walking speed (primary outcome). One group using vibrations (i.e. experimental group) and one group with sham vibration (i.e. control group) will take part to this study.


Eligibility Criteria:
Inclusion Criteria:

* Stroke patients in subacute rehabilitation phase (between 14 days and 3 months post-stroke)
* First hemispheric, ischemic or hemorrhagic stroke
* Lower-limb deficiency with an initial motor testing \< 4 according to the MRC scale
* No neurological history with functional impact other than stroke
* Having received informed information about the study and having signed the written consent
* Affiliated or entitled to a social security scheme.

Exclusion Criteria:

* Multiple stroke
* Other neurological, cognitive or psychiatric conditions
* Orthopedic ankle history compromising measurements
* Botulinum toxin injected in the lower limb prior the study protocol
* Patient with a skin lesion close to the site for the placement of the stimulator
* Patient under tutorship or curatorship
Evaluate the Bioavailability Between 2 BMS-986141 Formulations in Healthy Participants

Open label, randomized, 4-period crossover study with single doses of BMS-986141 given to healthy female subjects of non-childbearing potential and healthy males.


Eligibility Criteria:
Inclusion Criteria:

* Healthy participants as determined by no significant deviations in normal medical and surgical history and assessments
* Body mass index 18.0 kg/m2 to 32.0 kg/m2
* females must be of non-childbearing potential

Exclusion Criteria:

* known bleeding or coagulation disorders
* acute or chronic medical illness
* history of nausea or chronic diarrhea that lasts over 4 weeks
* history of periodontal disease or gingivitis which required treatment
* other exclusion criteria may apply
A Drug-Drug Interaction Study in Healthy Volunteers of the Effects of Tucatinib

This study is being done to look at how tucatinib could affect the way other drugs work. This study will look at healthy volunteers and how tucatinib affects their liver enzymes. Liver enzymes can change how drugs work in the body. There are 5 parts to this study. Parts A and C are looking at how the body breaks down tucatinib when there are lower levels of certain liver enzymes. Part B is looking at how the body breaks down tucatinib when there are high levels of certain liver and stomach enzymes. Parts D and E are looking at how tucatinib could change the levels of some liver and stomach enzymes in the body. This will help us know more about how tucatinib should be given to patients.

This is a fixed-sequence, drug-drug interaction study of tucatinib conducted in 5 parts in healthy subjects. Part A will evaluate the effect of the strong CYP3A4 inhibitor itraconazole on the pharmacokinetics (PK) of tucatinib. Part B will evaluate the effect of rifampin, a strong inducer of CYP3A4 and CYP2C8, on the PK of tucatinib. Part C will evaluate the effect of the strong CYP2C8 inhibitor gemfibrozil on the PK of tucatinib. Part D will evaluate the effects of tucatinib on the PK of substrate probes of the metabolizing enzymes CYP2C8 (repaglinide), CYP2C9 (tolbutamide), and CYP3A4 (midazolam). Part E will evaluate the effect of tucatinib on the PK of a substrate probe of the transporter P-gp (digoxin). Parts A, B, C, D, and E of the study are independent of one another and do not need to be conducted in a particular order.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) between 18 and 32 kg/m\^2
* In good health, determined be no clinically significant findings from medical history, physical examination, and screening evaluations
* Female subjects must be of nonchildbearing potential
* Male subjects must agree to use contraception or must be surgically sterile for at least 90 days prior to enrollment
* Able to understand and sign informed consent form

Exclusion Criteria:

* Any condition affecting drug absorption (including stomach or intestinal surgery)
* Significant history of metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder
* History of hypersensitivity, intolerance, or allergy to any drug compounds, food, or other substance (unless approved by Investigator)
* Participation in a clinical study involving an investigational drug within the past 30 days
* Use or intend to any prescription medications within 28 days prior to check in
* Use of tobacco- or nicotine-containing products within 28 days prior to check in
* History of hyperbilirubinemia
* History of alcoholism or drug abuse within 2 years
* History of regular alcohol consumption exceeding 7 drinks/week for female subjects or 14 drinks/week for male subjects
* Positive hepatitis panel and/or positive human immunodeficiency virus (HIV) test
Hepatitis C Virus (HCV) Treatment Completion or Withdrawal

Qualitative pilot study of patients' views of their experience with antiviral treatment for hepatitis C.

Qualitative pilot study of patient' views of their experiences with antiviral treatment for hepatitis C. Two groups of patients will be sampled: nine who completed a 24 or 48 week course of treatment and nine who withdrew from treatment prior to planned end. Interview data will be analyzed using narrative and grounded theory methods to identify attributes of treatment experience that may discriminate between completion and withdrawal.

Eligibility Criteria:
Inclusion Criteria:

Ever initiated anitiviral treatment for hepatitis C.

Exclusion Criteria:

none