cyrilzakka/clinical-trials huggingface dataset:
Fraxel Laser for Alopecia

This is a pilot study to evaluate the effect of the 1550 nm fractional erbium-glass laser in patients with nonscarring alopecias. Participants currently living in the Chicago metropolitan area and meet inclusion/exclusion criteria will be considered for enrollment. Participants will receive 5 sessions of laser, 30 days apart, to the area of alopecia on the scalp. Follow-up is at 150 days.

This study was a pilot study designed to determine feasibility of this procedure.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females ≥ 18 years old
2. Subjects are in good health as judged by the investigator.
3. Diagnosed by a dermatologist with mild to moderate androgenetic alopecia or alopecia areata.
4. Subject is seeking treatment for alopecia.
5. Subject has never previously used finasteride or minoxidil or has consistently used finasteride or minoxidil for at least 1 year.
6. Subjects who are willing and have the ability to understand and provide informed consent for participation in the study and are able to communicate with the investigator.

Exclusion Criteria:

1. Evidence of another skin condition affecting the treatment area that would interfere with clinical assessments.
2. Subjects who are unwilling to avoid initiating treatment with minoxidil or finasteride for the duration of the study; or in subjects who have been treated with minoxidil or finasteride for at least 1 year, unwilling to avoid changes in the dosing regimen of these medications for the duration of the study.
3. Willing to refrain from washing hair or using hair product 24 hours before and after treatment visits
4. History of recurrent facial or labial herpes simplex infection
5. History of hypertrophic scars or keloids
6. Subjects who have any requirement for the use of local or systemic steroids or other immunosuppressive agent
7. Pregnant or breast feeding
8. Uncooperative patients or patients with neurological disorders who are incapable of following directions or who are predictably unwilling to return for follow-up examinations.
9. Subjects who are unable to understand the protocol or give informed consent.
Analysis of Laboratory Markers for Severe COVID-19

The course of coronavirus infection was often severe and required hospitalization of patients in the intensive care unit. The new SARS-Cov-2 has been poor studied, so relatively reliable markers are needed to effectively monitor patients and predict complications and outcome. Taking into account the known mechanisms of pathogenesis, the biochemical markers as ferritin, procalcitonin, C-reactive protein and D-dimer were chosen for this purpose. Patients were divided according to the degree of pulmonary infiltration. We hypothesized that the markers would correlate with dynamics, complications, and outcomes.

In the presented study, an analysis of the medical records of 193 patients hospitalized in severe condition to the intensive care unit with a confirmed diagnosis of Coronavirus infection COVID-19 was carried out. Taking into account the volume of pulmonary infiltration according to computer tomography (CT) of the chest organs, patients were divided into 4 groups in accordance with the approved classification: CT 1(up to 25% of lung tissue was infiltrated) - 27 patients, CT 2 (25-50%) - 60 patients, CT 3 (50-75%) - 67 patients, CT 4 (75% and more) - 39 patients. The following biochemical parameters were selected and used to monitor dynamics: procalcitonin (PCT), C-reactive protein (CRP), D-dimer (DD), ferritin (FRT). The duration of observation was 15 days.

In order to determine correlations between quantitative and qualitative data at different stages of treatment, a correlation analysis was carried out (Spearman's test was used). ROC analysis was performed to evaluate selected laboratory markers as predictors of outcome. Next, the odds ratio (OR) was assessed taking into account the obtained Youden's J index and the Associated criterion for each of the selected markers in relation to the patient's outcome. Preliminary contingency tables were compiled in relation to laboratory parameters and outcomes (2x2 tables).

Data were processed using statistical software jamovi (Computer Software ,Version 2.3.26), MedCalc (MedCalc Software Ltd, Ostend, Belgium), Microsoft Office Excel, 2016.

Eligibility Criteria:
Inclusion Criteria:

* identified COVID-19 by nasopharyngeal material PCR, coronavirus associated lung infiltration, visualized by CT, and clinically severe condition

Exclusion Criteria:

* pregnancy
A Study of CDX-3379 and Cetuximab and in Patients With Advanced Head and Neck Squamous Cell Carcinoma

This is a study to determine the clinical benefit (how well the drug works), safety and tolerability of combining CDX-3379 and cetuximab. The study will enroll patients with advanced head and neck squamous cell carcinoma who have previously received cetuximab and progressed.

CDX-3379 is a fully human monoclonal antibody that binds to a molecule called human epidermal growth factor receptor 3 (HER3 or ErbB3) found on certain cells and may act to promote anti-tumor effects.

Cetuximab is a human monoclonal antibody that blocks EGFR, a protein receptor that regulates cell growth.

This study will evaluate the safety, tolerability and efficacy of CDX-3379 in combination with cetuximab in patients with advanced head and neck squamous cell carcinoma who have previously received cetuximab and progressed.

Eligible patients that enroll in the study will be given the dose of 12 mg/kg CDX-3379 once every 3 weeks in combination with 400 mg/m2 cetuximab on the first day followed by weekly doses of 250 mg/m2 cetuximab.

Up to 45 patients will be enrolled. All patients enrolled in the study will be closely monitored to determine if there is a response to the treatment as well as for any side effects that may occur.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically confirmed head and neck squamous cell carcinoma.
2. Human papilloma virus (HPV) negative tumor.
3. Prior treatment with a check-point inhibitor targeting PD-1, unless not a candidate.
4. Prior treatment with cetuximab with tumor progression during or within 6 months after completing treatment.
5. Measurable disease.
6. Life expectancy ≥ 12 weeks.
7. If of childbearing potential (male or female), agrees to practice an effective form of contraception during study treatment and for at least 6 months following last treatment.
8. Willingness to undergo a tumor biopsy prior to starting treatment (or if biopsy is not feasible, provide archival tissue).

Exclusion Criteria:

1. Previous treatment with CDX-3379 or other anti-ErbB3 targeted agents.
2. Nasal, paranasal sinus, or nasopharyngeal carcinoma, aside from WHO Type I and II (keratinizing, non-EBV positive) nasopharyngeal carcinoma which will be allowed.
3. Major surgery within 4 weeks prior to first dose of study treatment.
4. Chemotherapy within 21 days or at least 5 half-lives (whichever is shorter) prior to first dose of study treatment.
5. Monoclonal based therapies within 4 weeks (excluding cetuximab) and all other immunotherapy within 2 weeks prior to first dose of study treatment.
6. Other prior malignancy, active within 3 years, except for localized prostate cancer, cervical carcinoma in situ, non-melanomatous carcinoma of the skin, stage 1 differentiated thyroid cancer or ductal carcinoma in situ of the breast.
7. Active, untreated central nervous system metastases.
8. Active autoimmune disease or documented history of autoimmune disease.
9. Significant cardiovascular disease including CHF or poorly controlled hypertension.
Restorative Exercise for Strength Training and Operational Resilience (RESTORE) for Chronic or Recurrent Low Back Pain

The purpose of the study is to learn about the effect of integrative therapies on chronic or recurrent low back pain.

The intervention called RESTORE (Restorative Exercises for Strength Training and Operational Resilience) is based on a series of gentle stretching and strengthening exercises incorporating breath-work and mindfulness. The study is designed to discover the impact of RESTORE on pain levels, physical function, and behavioral health.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with lower back pain with a pain score of 4 or higher on DVPRS for 3 months
* Male or female
* Age 18-68\*
* Able to read and understand English
* Understands language, and able to report current pain levels and recall events
* DEERS-Eligible, Military healthcare beneficiary

Exclusion Criteria:

* Provider has advised against mild to moderate exercise
* Patient unable to sit on the floor for two minutes or unable to stand independently
* Complex Regional Pain Syndrome, Fibromyalgia, Chronic Fatigue Syndrome, Auto Immune disease-related pain, other chronic medical conditions (i.e. advanced diabetic neuropathies) that preclude consent
* Patients with severe TBI
* Practiced Yoga within 6 months
* Pre-surgical candidates for back surgery within 3 months
* Back surgery within the past year
* Pregnancy\*\*; females will be asked to self-report
* Undergoing Medical Evaluation Board to determine discharge
Functional Exercise After Total Hip Replacement

The aim of this research project is to evaluate the efficacy of a specific functional exercise programme to improve pain, stiffness and physical function in patients post total hip replacement from week 12 to week 18 post surgery.

This will be a single blind randomised controlled trial with two arms. 70 subjects post primary total hip replacement will be randomised either to a functional; exercise group (n=35) or to a control group following usual care (n=35).

Blinded outcome assessments will be carried out on all subjects by the principal investigator using the Western Ontario and Mc Master arthritis index on day 5 , week 12 aand week 18.

Secondary outcomes measurements will also be collated at week 12 and week 18 including SF 12, 6 min walk test, Dynamometry, and a blinded radiologist will also measure glut med cross sectional area using real time ultrasound at week 12 and week 18.

Eligibility Criteria:
Inclusion Criteria:

* 12 weeks post primary THR for osteoarthritis
* Age 50 years and above
* Able to read and understand and instructions in English
* Willing to attend classes twice weekly for 8 weeks
* Able to participate in an exercise programme without physical assistance
* Able to Mobilize independently 15m without crutches and /or stick -Passed by the referring Orthopaedic Consultant as suitable for inclusion at six week appointment -

Exclusion Criteria:

* Medically unstable
* Any central or peripheral nervous system deficits
* Any underlying terminal disease -Any suspicion of infection following joint replacement -
Virtually Assisted Home Rehabilitation After Acute STroke (VAST-rehab)

The purpose of this study is to investigate the feasibility of a virtual education and virtual visit program in engaging patients with rehabilitation at home after stroke.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent provided by the subject or legally authorized representative.
* Occurrence of a hemorrhagic or ischemic stroke
* pre-stroke mRS less than 3
* Qualifying Stroke Event must be confirmed by CT or MRI
* Recommended to participate in self-guided or in-person rehabilitation activities by a physician or rehabilitation therapist
* Must have sufficient cognitive and language abilities to comprehend verbal commands and to carry out the study assessments
* Able to access the internet via a personal device

Exclusion Criteria:

* . History of neurological or other disease resulting in significant functional impairment (e.g.Parkinson's disease, motor neuron disease, moderate dementia, arthritis,contractures or fixed anatomical abnormality).
* Subjects with a severe comorbid disorder that has reasonable likelihood of limiting survival to less than 6 months.
* Any other conditions that, in the opinion of the investigators, would preclude safe and/or effective participation.
Clinical Pharmacology of FYU-981 (Elder Subjects)

The purpose of this study is to assess the pharmacokinetics, safety and pharmacodynamics after single oral administration of FYU-981 to male and female elder subjects in comparison with non-elder subjects.


Eligibility Criteria:
Inclusion Criteria:

* Japanese adult subjects
* 20-35 Years (non-elder groups)
* 65- Years (elder groups)
* Body mass index: \>=18.5 and \<25.0

Exclusion Criteria:

* Subjects with any disease or any history of diseases that might be unsuitable for participation in the clinical study
Individualized Piano Instruction (IPI) for Improving Cognition in Breast Cancer Survivors.

The purpose of this study is to test the study method and procedure for individualized piano instruction (IPI) and its impact on chemotherapy related cognitive impairment (CRCI) symptoms. There have been studies that show the benefits of leaning to play the piano keyboard on cognitive skills in children and elderly populations. The information collected from the program will be used to examine the feasibility of implementing this program permanently


Eligibility Criteria:
Inclusion Criteria:

Patients will be included into the study who:

* Are over 18 years old
* Speaks and read English
* Have been diagnosed and treated for breast cancer (no specific etiology);
* Are experiencing cognitive issues (i.e. actively complain to their physician about struggles with cognitive skills such as memory, attention, executive function, etc.);
* Are 6 months or more out of active treatment;
* Are not currently involved in other brain training programs.

Exclusion Criteria:

* Adults who are diagnosed with a cognitive condition other than CRCI (Such as Alzheimer's, Parkinson's, dementia, Amyotrophic Lateral Sclerosis (ALS), autism, and cerebral palsy.)
* Patients who are in active treatment for breast cancer (Currently hospitalized for chemotherapy or still visiting hospital for outpatient infusion treatment)
* Adults who cannot read and write in English fluently.
* Adults who do not have functional movements in their hands, as assessed by tendon gliding and finger opposition exercises provided by a physical hand therapist.
* Adults who plan to not be in Miami for a period eight weeks or are unable to travel to Sylvester Miami on a weekly basis.
* Adults who are already proficient in piano playing, music theory and play informally or professionally at least once per week.
* Elderly adults, those older than 65 years old.
Association Between Stroke and Adrenal Incidentalomas

Adrenal incidentalomas (AIs) are commonly encountered in transsection imaging which purpose not for suspected adrenal disease. However, part of AIs in patients is associated with Stroke. Stroke is a diseases which could cause of disability and death worldwide. In clinical practice, detailed information about the association between stroke and AIs is not available. In this study, the investigators aimed to investigate the risk for disability and death in the large group of stroke patients with AIs.

Background:

Adrenal incidentalomas (AIs) are commonly encountered in transsection imaging which purpose not for suspected adrenal disease. However, part of AIs in patients is associated with Stroke . The investigators aimed to investigate the risk for disability and death in the large group of stroke patients with AIs.

Objective:

To measure the association between stroke and levels of autonomous cortisol secretion in patients with AIs.

Design:

Part 1, Retrospective cohort study.

From April 1, 2021, to September 30, 2021, cohort patients with stroke were recruited in this study. The investigators assess the standardised incidence rate of AIs in all patients. Meanwhile, detail information about stroke disease、patient and AIs characteristics were record.

Part 2, Prospective cohort study.

From Mar 1, 2022, to Feb 29, 2024, cohort patients with stroke plane to recruit in this study. All patient receive the plasma cortisol level after a 1-mg dexamethasone suppression test. The investigators assess the standardised incidence rate of AIs in all patients. Meanwhile, detail information about stroke disease、patient and AIs characteristics would be record.

Eligibility Criteria:
Inclusion Criteria:

* stroke disease , such as Cerebral infarction、Intracerebral hemorrhage and Subarachnoid hemorrhage.

Exclusion Criteria:

* presence of metastatic cancer;
* AIs smaller than 1 cm;
* nonadenoma lesions, such as myelolipomas,hemorrhages, and cysts;
* oral glucocorticoid treatment with more than single doses in the past 3 months;
* use of inhaled steroids or medication affecting dexamethasone metabolism;
* systemic estrogen treatment.
Restore EF Observational Study

A multi-center, prospective, observational, non-interventional single arm, study of the intermediate-term clinical outcomes collected from electronic health records of high-risk patients which have previously undergone standard of care prophylactic Impella support for a non-emergent percutaneous coronary intervention (PCI).

1. Hypothesis The prophylactic use of Impella 2.5 or CP heart pumps during a non-emergent PCI in hemodynamically stable patients at high-risk for periprocedural complications during the procedure is associated with a significant improvement in the patient's LVEF and clinical status (heart failure symptoms and hospital readmissions) in the intermediate-term follow-up period post-ProPCI
2. Objectives The primary objective of this study is to assess the patient's LVEF at 90 days post-ProPCI (60 to 180 days window) as assessed in routine clinical practice and collected from EHR by clinical investigators.

   The secondary objective of the study is to assess the potential association between the completeness of revascularization and the clinical status at 90 days post-ProPCI (60-180 days window). Clinical status includes NYHA heart failure functional class and hospital readmission.
3. Sample Size: The study will enroll more than 1,000 patients at up to 30 investigational sites with experienced Impella operators (≥ 25 cases).
4. Primary Endpoint: Subject's LVEF at 90 days post-ProPCI (60 to 180 days window) collected from the subject's EHR.
5. Secondary Endpoints:

   * Completeness and extent of revascularization
   * NYHA functional class at 90 days post-ProPCI (60 to 180 days window)
   * Readmission at 90 days post-ProPCI (60 to 180 days window)

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Subject has previously undergone (≥ 60 days) an Impella Protected PCI (ProPCI) at a study site as identified in the Impella quality (IQ) assurance database (patients who expired or were lost to follow-up prior to opening of the follow-up study window (day 60 post Impella protected PCI) will not be included in the study

Exclusion Criteria:

* Subject with cardiogenic shock at the time of Impella insertion. Cardiogenic shock defined as: systemic hypotension (systolic blood pressure (SBP) \<90 mmHg or the need for inotropes/pressors to maintain a SBP \>90mmHg)
* Subject with ST elevation myocardial infarction at the time of Impella insertion.
* Subject underwent coronary bypass surgery after the index Impella ProPCI
* Subject underwent repeat revascularization with PCI after the index Impella ProPCI
* Subject underwent other cardiac procedures including valve therapies (surgical or percutaneous) after the index Impella ProPCI
* Subject underwent cardiac resynchronization therapy (CRT) initiated after the index Impella ProPCI
* Any known medical condition with a life expectancy \<6 months
Bioequivalence Study of Amoxicillin 400 mg/Clavulanic Acid 57 mg Chewable Tablets Under Fasting Conditions

The objective of this study was to compare the single-dose relative bioavailability of Ranbaxy and GlaxoSmithKline (Augmentin®) 400 mg amoxicillin (as the trihydrate) and 57 mg clavulnic acid (as the potassium salt) chewable tablet, following administration of 2 tablet dose under fasting conditions

The study was conducted as an open-label, randomized, 2-way crossover study to compare the single-dose relative bioavailability of Ranbaxy and GlaxoSmithKline (Augmentin® 400 mg) amoxicillin (as the trihydrate)/57 mg clavulanic acid (as the potassium salt) chewable tablet, following administration of 2 tablet dose under fasting conditions A total of 40 subjects (22 males and 18 females) were included in this study, of which 39 (21 males and 18 females) finished the study according to the protocol.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy adult male or female volunteers, 18-55 years of age
2. Weighing at least 52 kg for males and 45 kg for females and within 15% of their ideal weights (Table of "Desirable Weights of Adults", Metropolitan Life Insurance Company, 1983);
3. Medically healthy subjects with clinically normal laboratory profiles;
4. Females of childbearing potential should either be sexually inactive (abstinent) for 14 days prior to the study and throughout the study or be using one of the following acceptable birth control methods:

   surgically sterile (bilateral tubal ligation, hysterectomy bilateral oophorectomy) 6 months minimum; IUD in place for at least 3 months; barrier methods (condom, diaphragm) with spermicide for at least 14 days prior to the start of the study and .throughout the study; surgical sterilization of the partner (vasectomy for 6 months minimum); hormonal contraceptives for at least 3 months prior to the start of the study. Other birth control methods may be deemed acceptable. Postmenopausal women with amenorrhea for at least 2 years will be eligible;
5. Voluntarily consent to participate in the study.

Exclusion Criteria:

Subject candidates must not be enrolled in the study if they meet any of the following criteria:

1. History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic,gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease.
2. In addition, history or presence of:

   alcoholism or drug abuse within the past 2 years; hypersensitivity or idiosyncratic reaction to antibiotics, especially penicillins, cephalosporins and amoxicillin and/or clavulanic acid
3. Female subjects who are pregnant or lactating.
4. Subjects who have been on an abnormal diet (for whatever reason) during the 30 days prior to the first dose.
5. Subjects who have made a donation (standard donation amount or more) of blood or blood products (with the exception of plasma as noted below) within 30 days prior to the study.
6. Subjects who have made a plasma donation within 7 days prior to the study
7. Subjects who have participated in another clinical trial within 30 days prior to the first dose.