cyrilzakka/clinical-trials huggingface dataset:
A Study of Abemaciclib in Healthy Participants

The purpose of this study is to measure how much abemaciclib gets into the blood stream and how long it takes the body to get rid of it when given as capsules versus a tablet(s). The effect of a high fat meal on the tablet formulation will also be evaluated. In addition, the tolerability of abemaciclib tablet and capsule formulations will be evaluated. Information about any side effects that may occur will also be collected.

This study has 3 parts. Parts A and C will last about 44 days including follow-up. Part B will last about 60 days including follow-up. Screening may occur up to 28 days before the first dose of study drug. Participants are only allowed to enroll in one part.

This study is for research purposes only and is not intended to treat any medical condition.


Eligibility Criteria:
Inclusion Criteria:

* Healthy surgically sterile or postmenopausal females and sterile males
* Have a body mass index (BMI) 18 to 32 kilograms per square meter (kg/m²)

Exclusion Criteria:

* Have known allergies to abemaciclib, related compounds, or any components of the formulation
* Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
* Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
* Show evidence of hepatitis C and/or positive hepatitis C antibody
* Show evidence of hepatitis B and/or positive hepatitis B surface antigen
Valproate Versus Topiramate in Migraine

Investigators aim to compare the effect of valproate versus topiramate in migraine by assessing the reduction in MMD in each group, the percentage of patients who achieved ≥ 50% reduction in the monthly headache days frequency compared to the baseline frequency.

Investigators will enroll 600 migraine patients who are diagnosed according to ICHD3-beta criteria in our study and will use a questionnaire to detect their demographic and clinical features (disease duration, attack frequency, and duration, pain intensity assessed by the visual analogic scale and we have two groups the first group will include 300 patients and will receive 500-1000mg valproate daily and Acetaminophen 500-1000 mg in acute attack, and the second group will receive topiramate100 mg per day and Acetaminophen 500-1000 mg in acute attack for at least three months. Investigators will assess The number of migraine days after three months of treatment and the percentage of patients who achieved ≥ 50% reduction in the monthly headache days frequency compared to the baseline frequency (14).. HIT-6 score reduction in each group after three months of treatment. The safety of treatment was evaluated by monitoring and documenting treatment-emergent adverse events (TEAE) in patients through regular follow-up procedures for three months.

Eligibility Criteria:
Inclusion Criteria:

Naive migraine patients, according to the International Classification of Headache Disorders 3rd edition, aged 18-75 years,

Exclusion Criteria

* Patients with major neurological disorders such as ( epilepsy, ischemic or hemorrhagic stroke, multiple sclerosis, mitochondrial diseases, brain tumors, and patients with essential tremors.
* Patients with major systemic diseases such as malignancy, collagen, liver, and renal diseases.
* Patients with cardiovascular diseases like hypertension (systolic blood pressure of more than 130 and/or diastolic blood pressure of more than 85 mm/Hg on at least three different occasions, diabetes (fasting plasma glucose level \>126 mg/dl and/or a casual plasma glucose \>200 mg/dl and/or HbA1C more than 6.5.
* Patients with valvular and ischemic heart diseases, bradycardia or heart blocks, congestive heart failure patients who received prophylactic treatment for migraine, patients with any contraindications to drugs used in the study Patients with topiramate or valproate contraindications.
Adaptation in Lower Extremity After 3 Running Days, With a Group Trained by Eccentric Overload

This study evaluates the changes in muscles and tendons in the lower limb after an intervention of fatigue during 3 consecutive days between trained or not healthy subjects. One of the 2 groups received training by eccentric overload previously.

Changes in muscle and tendon tissues, due to exercise, could determine in the future the possibility of an injury. Understand the changes in the mechanical tissues is a key tool for prevention.

The evaluation of the thickness and area in tendons, the existence of new vessels within the tendon, muscle pennation angle or thermography are tools that have been widely used to detect these changes.

Running is one of the activities that can cause more muscle-tendon injuries, specially overuse injuries. However, the eccentric exercise suggest to make some adaptations in different tissues that may be beneficial to prevent damage after exercise.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects that performs any sport usually
* Subjects that never have made eccentric training will be included.
* Subjects must be willing to perform the procedure
* Sign informed consent

Exclusion Criteria:

* Subjects enrolled with lower limb pathology in last 6 months
* Subjects that don´t complete all the procedure will be excluded.
KIDney Injury in Times of COVID-19 (KIDCOV)

There is an unmet need to evaluate the impact of sub-clinical/mild COVID19 disease in the outpatient setting on prevalent and incident renal injury, as this data is currently unavailable. To capture the diversity of race/ethnic risk and COVID19 related municipal shelter-in-place guidance, the investigators will enroll COVID19-negative and COVID19-positive samples balanced by race/ethnicity from 3 different states, California, Michigan, and Illinois. Study endpoints will be assayed from urine samples mailed to the study team at 2, 6, and 12 months after their date of PCR test, with no requirement for these individuals to leave their homes to participate.

KIDCOV is a longitudinal cohort study that will prospectively follow cohorts of COVID19-negative and COVID19-positive adults for episodes of kidney injury over a 12-months period. Study candidates will be identified via site-specific electronic medical records (EMR) at seven academic medical centers in the U.S. within 4 weeks of a PCR-based test for SARS-Cov2. Screen-positive individuals will be contacted by email or text and invited to complete an online consent form documenting their willingness to participate. Participation will involve completion of questionnaires and return of urine samples in mailed collection kits at 2, 6, and 12 months after their date of PCR test. The primary endpoint will be the urine-based KIT Score, based on the composite measurement of multiple DNA, protein and metabolite urinary biomarkers (reference). Secondary endpoints include NGAL and KIM-1 urinary biomarkers for kidney injury assessment.

Early detection of new or worsening kidney injury is urgently needed in order to implement preventative measures and target therapeutics that can minimize excess post-COVID19 kidney damage. A complete and standardized understanding of the trajectory and risk factors for kidney injury associated with COVID19+ disease is critical to informing the design and implementation of preventative and therapeutic strategies for COVID19-mediated kidney injury.

Eligibility Criteria:
Inclusion Criteria:

* Result of PCR-based COVID-19 test conducted in the past 4 weeks posted in EMR of participating AMC
* Age 18 years or older at enrollment
* Race/ethnicity, sex, age, and phone and/or home/email address provided

Exclusion Criteria:

* Failure of a candidate participant to give written informed consent to comply with the study protocol
* Hospitalization up to 4 weeks after SARS-CoV-2 test
* History of kidney transplant
* History of dialysis
Prospective Randomized Study of Brain Protection During Aortic Arch Replacement

The purpose of this research study is to evaluate two standard approaches of supplying blood and oxygen to your brain during open heart surgery.

The purpose of the clinical trial is to assess the best method of protecting the brain during long periods of circulatory arrest. The significance of this project will be to determine which method of brain protection (1) retrograde brain perfusion or (2) perfusion of the right subclavian artery with antegrade perfusion of the brain protects against brain injury after total arch replacement. Thus reducing the risk of stroke or neurocognitive deficits in patients undergoing this critical surgical procedure.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing a total arch replacement
* Less than 75 years old

Exclusion Criteria:

* EF less than 35%
* Pt shows evidence of major illness e.g. severe hepatic disease, severe renal failure, active cancer or major infection
* Pt unable to complete preop neuro assessment
* Pt is unwilling or able to complete followup requirements
* Pt is already enrolled in other new device or drug protocols that have not completed the primary endpoint or that clinically interferes with study endpoint
* Pt is a female who is pregnant or lactating
* Pt has history of stroke
SCP vs HUSLS for Pelvic Organ Prolapse Repair

The purpose of this study is to compare the effectiveness of R-SCP versus HUSLS for treatment of pelvic organ prolapse.

To compare the effectiveness of Robotic Sacrocolpopexy versus vaginal High Uterosacral Ligament Suspension for treatment of pelvic organ prolapse. Both surgeries are standard of care and are equally and widely used throughout the country with well known safety and efficacy.

Eligibility Criteria:
Inclusion Criteria:

* 18 Years of age or older
* Signed Informed Consent
* Symptomatic pelvic organ prolapse,
* Willing and able to complete all study visit

Exclusion Criteria:

* Non-High Uterosacral Ligament Suspension (unable to do HUSLS at time of surgery),
* Dementia or considered unable to complete questionnaires

  1. Hx of Alzheimer Disease
  2. Hx multiple strokes or other neurologic condition
  3. Caregiver states the subject is unable to complete
  4. MDs opinion
* Inability to complete follow up visits due to transportation issues

  1. No access to transportation (ie. does not have vehicle)
  2. Live \> 2 hours from LLUH
  3. Does not have financial means
* Congenital anomalies

  1. Bladder Exstrophy
  2. Connective tissue disease
  3. Neovaginal prolapse
  4. Prolapse of sex change vagina
* Chronic pelvic pain

  1. \> 6 months of pelvic pain of undetermined origin
  2. not cyclic pain (eg. period pain or dysmenorrhea)
  3. Patient has comorbidities of CPP
  4. Fibromyalgia
  5. Interstitial cystitis
  6. Vulvodynia
* Contraindications to Mesh,

  1. Opposition to the use mesh (ie. due to religious beliefs)
  2. History of mesh complications in past
* Pregnant or planning to become pregnant during the study period.
Inflammation in Tinnitus

Rationale: Tinnitus is the perception of sound without an external source. In the past decade, inflammation has been implicated in the pathophysiology of tinnitus. In animal models of tinnitus, the expression of proinflammatory cytokines Tumor Necrosis Factor-α (TNF-α) and interleukine-1β (IL-1β) was increased throughout the whole auditory tract. Only two studies evaluated cytokine concentrations in tinnitus patients. In these studies an increase of IL-6 and decrease of IL-10 have been objectified. However, studies did not include tinnitus patients based on the degree of hearing loss, despite that inflammation has also been implicated in hearing loss. On the other hand, studies about inflammation in hearing loss did not (always) exclude tinnitus. Thus, it remains unclear whether the upregulated cytokine concentrations the studies are specific for tinnitus, and whether potential effects remained unsignificant because the presence of hearing loss is a confounder. Therefore, the aim of this study is to evaluate the presence of inflammation in tinnitus patients with normal hearing.

Objective: The main objective is to evaluate the presence of inflammation in blood samples of human subjects with tinnitus and normal hearing, compared to healthy controls. The secondary objective is to evaluate the relation between tinnitus severity and inflammatory marker concentrations.

Study design: This is a cross-sectional study.

Study population: Patients who have been referred to the tinnitus consultation at the outpatient clinic will be asked to participate in this study. For the control group, healthy volunteers will be recruited.

Main study parameters/endpoints: The main study parameter is the disparity in blood cytokine levels between participants with and without tinnitus. Secondary study parameters are the relation between tinnitus severity and blood cytokine concentration, and the difference in complete blood count measures in participants with and without tinnitus.


Eligibility Criteria:
Inclusion Criteria:

* To be eligible to participate in this study, a subject must meet all of the following criteria:
* Adult, aged 18 years or older;
* Hearing threshold: average of 1000kHz, 2000kHz \& 4000kHz ≤ 25 dB.
* Anxiety score HADS ≤ 7
* Depression score HADS ≤ 7
* Participant has sufficient mastery of the Dutch language to fill out the questionnaires.
* Psychosocially, mentally, and physically able to fully comply with this protocol.

Exclusion Criteria:

* Objective tinnitus.
* Presence of neurological disease (apart from tinnitus)
* Presence of inflammatory disease, or the use of anti-inflammatory medication.
* Presence or history of a malignancy
* Presence of a disease of the ear (e.g. chronic otitis media, otosclerosis, previous surgery etc).
* Presence of an coagulation disorder
* Presence of a serious psychiatric disorder.
* Pregnancy
PEP005 Gel - Biological Effects in Actinic Keratosis Assessed by Reflectance Confocal Microscopy

This trial will be conducted to explore the biological effects in the skin following treatment with PEP005 Gel, 0.05% administered for two consecutive days, assessed by reflectance confocal microscopy.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects at least 18 years of age
2. Subjects with AK lesions and subclinical AK lesions within a contiguous 25 cm2 area on the upper extremity
3. Subjects must have a 25 cm2 area of normal skin on the inner upper arm
4. Female subjects must be of either:• Non-childbearing potential, post-menopausal, or have a confirmed clinical history of sterility or • Childbearing potential, with a confirmed negative urine pregnancy test prior to exposure.
5. Female subjects of childbearing potential must be willing to consent to using high effective methods of contraception
6. Ability to follow trial instructions and likely to complete all trial requirements
7. Obtained written informed consent prior to any trial-related procedures

Exclusion Criteria:

1. Location of the selected treatment areas:• Within 5 cm of an incompletely healed wound or infected area of the skin • Within 10 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma(SCC)
2. History or evidence of skin conditions other than the trial indication that would interfere with evaluation of the investigational product
3. Clinical diagnosis/history or evidence of any medical condition that would expose a subject to an undue risk of a significant AE or interfere with assessments of safety during the course of the trial, as determined by Investigator clinical judgment
4. Anticipated need for in-patient hospitalisation or in-patient surgery during the trial period.
5. Current participation in any other interventional clinical trial
6. Subjects who have received treatment with any non-marketed drug product within the last two months
7. Previous enrolment in this clinical trial
8. Prohibited Therapies and/or Medications 2 weeks prior to the Screening visit within 2 cm of selected treatment area:•Cosmetic or therapeutic procedures •Use of acid-containing therapeutic products • Use of topical salves or topical steroids
9. Prohibited Therapies and/or Medications: within 4 weeks prior to the Screening visit: • Treatment with immunomodulators, cytotoxic drugs or interferon/interferon inducers,systemic medications that suppress the immune system, or with UVB
10. Prohibited Therapies and/or Medications: within 8 weeks prior to the Screening visit: • Treatment with 5-FU, imiquimod, diclofenac, or photodynamic therapy: within 2 cm of the selected treatment areas.
11. Use of systemic retinoids
Effects of Lower Trapezius Strengthening Versus Scapular Mobility Exercise Among Snooker Players in Unilateral Neck Pain

Effects of lower trapezius strengthening versus scapular mobility exercise among snooker players in unilateral neck pain.

Effects of lower trapezius strengthening versus scapular mobility exercise on pain, range of motion and disability among snooker players in unilateral neck pain.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 - 35 years,
* Males snooker players
* Neck pain perceived by individual as being on one side of the neck Pain 3 or more month in duration.
* Participants with 6-7 level of pain on NPRS scale
* Participants with scapular mobility limited

Exclusion Criteria:

* Neck pain perceived by individual as being centrally located or on both sides of neck.
* Radicular symptoms
* History of cervical spine surgery
* Traumatic neck injury
* underlying neurological condition
Dexamethasone for Post Uterine Artery Embolization Pain

The purpose of this research is to investigate if administration steroids (anti-inflammatory medication) via the uterine arteries during uterine fibroid embolization (A non surgical procedure for treating uterine fibroids by blocking their blood supply) can help reduce the pain, nausea, vomiting, and general feeling of weakness following the procedure.


Eligibility Criteria:
Inclusion Criteria:

* Women who meet criteria to undergo uterine fibroid embolization for symptomatic fibroids.

Exclusion Criteria:

* Currently pregnant or actively attempting to conceive
* Those deemed mentally impaired to make their own medical decisions
* Previous documented allergy to dexamethasone
* Those currently taking daily steroids for any reason
* Those with diabetes or deemed to be pre-diabetic
* Those with contraindications for angiography
* Prisoners
Relative Bioavailability of BI 207127 Trial Formulation II Prototypes Versus BI 207127 Trial Formulation I in Healthy Volunteers

Study to investigate the relative bioavailability of 5 new 400 mg tablet formulations (trial formulation II prototypes) of BI 207127 compared to the current 200 mg BI 207127 tablet formulation (trial formulation I) in healthy male volunteers with the aim to identify the best formulation for further drug development (formulation finding part / trial part 1) and to investigate the effect of food on the relative bioavailability of the most promising one of these trial formulation II prototypes (food-effect part / trial part 2).


Eligibility Criteria:
Inclusion Criteria:

* Healthy males according to a complete medical history, including a physical examination,vital signs (blood pressure (BP), pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
* Age 18 to 50 years, inclusive
* Body mass index 18.5 to 29.9 kg/m2, inclusive
* Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation

Exclusion Criteria:

* Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
* Any evidence of a clinically relevant concomitant disease
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Surgery of the gastrointestinal tract (except appendectomy)
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* History of relevant orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
* Intake of drugs with a long half-life (\> 24 hours) within at least one month prior to administration of the trial drug or during the trial
* Use of any drugs (including herbal preparations, vitamins and nutrient supplements) within 14 days prior to first administration of the trial drug or during the trial
* Participation in another trial with an investigational drug within two months prior to administration of the trial drug or during the trial
* Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day)
* Alcohol abuse (more than 40 g/day)
* Drug abuse
* Blood donation (more than 100 mL within four weeks prior to first administration of the trial drug or during the trial)
* Excessive physical activities (within one week prior to first administration of the trial drug of the trial drug or during the trial)
* Any laboratory value outside the reference range that is of clinical relevance
* Inability to comply with dietary regimen of trial site
* A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval \>450 MS)
* A history of additional risk factors for Torsade de Points (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
* History of photosensitivity or recurrent rash
Laparoscopic Intersphincteric Resection in Elderly Patients

The aim of the present study is to assess if it is possible to offer intersphincteric rectal resection (IRR) to selected patients older than 70 years affected by ultra-low rectal cancer. The study, involving patients with rectal cancer at less than 5 cm from the anal verge, will compare elderly patients refusing standard sphincteric demolition and undergoing IRR, with some control groups (younger patients undergoing IRR, \>70 years old patients undergoing abdominoperineal resection + colostomy in left iliac fossa, \>70 years old patients undergoing abdominoperineal resection + perineal colostomy). The groups will be compared in terms of quality of life, quality of life associated to incontinence, overall survival, disease free survival and post-operative complications. This will be helpful to identify conditions for extending IRR to elderly patients. The study is run by Colo-rectal Surgery Unit at Policlinico San Matteo in Pavia (Italy) from 2009 to 2016, directly led by Dr. Sandro Zonta (principal investigator) and funded by the hospital itself.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 70 years old who were affected by rectal cancer sited lower than 5 cm from anal verge and refused abdomen-perineal treatment.

Exclusion Criteria:

* Cancer extension over internal sphincteric muscle (T4) evaluated through MRI during staging work out;
* diabetic neuropathy conditioning previous partial/total incontinence;
* other pre-existing pathological condition affecting faecal incontinence.
Body Composition and Sport Performance Among Young Female Soccer Players Using Subdermic Etonogestrel

The goal of this clinical trial study is to evaluate the effect of subdermic etonogestrel implant on body composition, sport performance parameters, quantify bleeding patters and quality of life parameters among young female soccer players.

Studies indicate a worsening of performance in young people with excessive menstrual bleeding and menstrual cramps. Hormonal contraception has been used to "manipulate" menstrual symptoms among physically active women, amateur and elite athletes. The use of the etonogestrel subdermal implant (Implanon NXT) would be a good option for young female soccer players. The goal of this study is to evaluate some parameters among young female soccer players under 17 years old during one year, in use of subdermic etonogestrel implant comparing with a non-users subdermic etonogestrel implant

Eligibility Criteria:
Inclusion Criteria:

- sexually active women of childbearing potential, with no contraindications to the use of a progestogen and who agreed to participate in this study.

Exclusion Criteria:

* breastfeeding, irregular vaginal bleeding, increased risk of thromboembolism, ischemic heart disease or other medical conditions