Kornimate/medical-research-clean huggingface dataset:
efficacy, safety and tolerability of topical 10% terbinafine hydrogen chloride versus 5% amorolfine nail lacquer in patients with mild to moderate toenail onychomycosis

Conditions: Onychomycosis

Summary: this study will evaluate the efficacy, safety and tolerability of topical 10% terbinafine hydrogen chloride applied daily versus 5% amorolfine nail lacquer applied twice a week in patients with mild to moderate toenail onychomycosis, for a total treatment duration of 48 weeks.


Eligibility criteria:
inclusion criteria: * male and females 12 - 75 years of age * fungal toenail infection of one or both of the large (great) toenails * the nail infection must be due to a dermatophyte, (mixed infections \[dermatophyte and non-dermatophyte\] are not allowed) * the target toenail area must have at least 25% to no more than 75% disease involvement without spikes. exclusion criteria: * target foot must not have severe plantar (moccasin) tinea pedis that would require systemic therapy. mild to moderate tinea pedis (athlete's foot) infection should be treated with terbinafine prior to baseline or at any time during the trial. other topical treatments for athlete's foot may be recommended at the discretion of the investigator. * subjects must not have abnormalities of the nail that could prevent a normal appearing nail if clearing of infection is achieved * no administration of systemic antifungal medications within 6 months prior to screening visit * no application of prescription topical antifungal medications for toenail fungus within 3 months or other commercially available topical medications for toenail fungus applied directly to the toenails within 1 month prior to screening visit * patients with the target toenail involving the matrix (lunula) or having less than 2mm clear (unaffected) nail plate length beyond the proximal fold. * presence of dermatophytoma (defined as thick masses of fungal hyphae and necrotic keratin between the nail plate and nail bed) on the target nail. * no professional pedicures or application of any nail polish product or nail cosmetic to the toenails after the screening visit * known pregnancy or lactation at time of enrollment other protocol-defined inclusion/exclusion criteria may apply

Keywords: toenail fungus onychomycosis nail fungus toenail fungal infection tinea unguium dermatophytes foot dermatoses
immunodeficiency in ms

Conditions: Multiple Sclerosis; Hypogammaglobulinemia; Immunodeficiency; Infection, Bacterial

Summary: the purpose of this study is to identify if there is a relationship between multiple sclerosis disease-modifying therapy exposure, immunodeficiencies, and infection risk in subjects living with ms.

the purpose of this study is to identify if there is a relationship between multiple sclerosis disease-modifying therapy exposure, immunodeficiencies, and infection risk in subjects living with ms. by understanding this relationship future studies can be designed to create a model of immunosenescence in multiple sclerosis, which could help healthcare providers to predict and assess health risks. preventative strategies can then be tested to look for ways to prevent these immune-related risks.

Eligibility criteria:
inclusion criteria * one or more immunoglobulin level results and medical history available * 18 years of age or older at the time of data collection * patients with first symptom ms or other isolated demyelinating syndromes, neuromyelitis optica, or rheumatic-associated cns inflammation exclusion criteria: * no evidence of cns autoimmune disease * less than 18 years of age at the time of data abstraction * undergoing plasma exchange at the time of any lab tests drawn
comparison of fulvestrant (faslodex™) 250 mg and 500 mg in postmenopausal women with oestrogen receptor positive advanced breast cancer progressing or relapsing after previous endocrine therapy.

Conditions: Breast Cancer

Summary: the purpose of this study is to evaluate the efficacy of a new dose of 500 mg fulvestrant with the standard dose of 250 mg in postmenopausal women with oestrogen receptor positive advanced breast cancer who have failed on a previous endocrine treatment.


Eligibility criteria:
inclusion criteria: * breast cancer has continued to grow after having received treatment with an anti-estrogen hormonal treatment such as tamoxifen or an aromatase inhibitor * requiring hormonal treatment * postmenopausal women defined as a woman who has stopped having menstrual periods * evidence of positive estrogen receptor hormone sensitivity * written informed consent to participate in the trial exclusion criteria: * treatment with an investigational or non-approved drug within one month * an existing serious disease, illness, or condition that will prevent participation or compliance with study procedures * a history of allergies to any active or inactive ingredients of faslodex (i.e. castor oil) * treatment with more than one regimen of chemotherapy for advanced breast cancer * treatment with more than one regimen of hormonal treatment for advanced breast cancer

Keywords: advanced breast cancer metastatic breast cancer
study of ngm707 as monotherapy and in combination with pembrolizumab in advanced or metastatic solid tumor malignancies

Conditions: Mesothelioma; Glioblastoma; Renal Cell Carcinoma; Non Small Cell Lung Cancer; Melanoma; Pancreatic Ductal Adenocarcinoma; Gastric Cancer; Squamous Cell Carcinoma of Head and Neck; Cholangiocarcinoma; Breast Cancer; Ovarian Cancer; Cervical Cancer; Endocervical Cancer; Colorectal Cancer; Esophageal Cancer

Summary: study of ngm707 as monotherapy and in combination with pembrolizumab in advanced or metastatic solid tumor malignancies


Eligibility criteria:
inclusion criteria: * histologically or cytologically documented locally advanced or metastatic solid tumor malignancy. * progressed or was intolerant to all available therapies known to confer clinical benefit appropriate for their tumor type, and for which the patient was eligible and willing to receive, or refused soc treatments that are perceived to have marginal clinical benefit. * adequate bone marrow, kidney and liver function. * performance status of 0 or 1. * resolved acute effects of any prior therapy to baseline severity or ctcae grade 1 except for aes not constituting a safety risk by investigator judgement. exclusion criteria: * prior treatment targeting ilt2 and/or ilt4 or targeting hla-g.
the effects of preloading before beach chair position

Conditions: Shoulder Injuries; Anesthesia; Hemodynamic Instability

Summary: the main objective of this study is whether preloading before positioning would be effective for less hemodynamic instability. the study also analyzes that patients with preloading will decrease postoperative nausea and vomiting, better surgical satisfaction and shortened the duration of surgery and anesthesia.

keeping patients in normovolemic state and hemodynamically stable in anesthesia and intensive care practice are important goals of anesthesiologist. it is known that hypotension that develops after taking patients to the beach chair position has a negative effect on cerebral oxygenation. aggressive fluid regimes using to prevent hypotension can cause glycocalyx damage, edema and organ dysfunction. also hypertension seconday to vasopressor therapy can cause bleeding at the surgical site and impaired surgical visualization during the arthroscopic shoulder surgery. in the literature, there are studies examine whether the hypotension is the result of decreased cardiac output or decreased systemic resistance and what should be the optimal treatment , but as far as investigators know, there is no study about effects of preloading before the beach chair position on hemodynamic parameters.

Eligibility criteria:
inclusion criteria: * undergoing elective arthroscopic shoulder surgery in the bcp, * age older than 18 years and younger than 65 years, * the american society of anesthesiologist (asa) physical status of i or ii, * accepting the study protocol. exclusion criteria: * preoperative arrhythmia, * significant heart failure * valvular heart disease, * preexisting cerebrovascular disease, * deciding to switch to open surgery, * vasopressor infusion during the surgery, * using angiotensin converting enzyme inhibitors (acei) orangiotensin receptor blockers (arb) as antihypertensive medication.

Keywords: beach chair position arthroscopic shoulder surgery preloading hemodynamic stability postoperative nausea and vomiting
exercise therapy with telerehabilitation in patients living with hiv

Conditions: HIV Infections

Summary: to investigate the effectiveness of the biopsychosocial exercise therapy approach (bety) approach with the telerehabilitation in patients living with hiv (plwh).

55 individuals living with hiv (plwh) were included in the study. among those individuals, 25 individuals who volunteer to exercise with telerehabilitation will be grouped in the telerehabilitation group. the rest of the individuals who do not participate in the exercise group will be in the control group. group 1: telerehabilitation group: individuals in the telerehabilitation group attend sessions that last for one and a half hours, 3 days a week for 12 weeks, in the company of an investigator over the videoconference through zoom. the investigator, who provides supervision during the sessions, also participates in the exercises simultaneously. group 2: control group: individuals in the control group continue their routine drugs. both the telerehabilitation exercise group and the control group continue their drug treatments during the 12 weeks of the period.

Eligibility criteria:
inclusion criteria: * patients living with hiv (plwh), * ages between 18 and 65 years old, * participants attend and follow instructions through telerehabilitation. exclusion criteria: * participants who use recreational drugs * participants who do not adapt to the exercises through telerehabilitation, * participants who did not agree to be volunteers are not included in our study.

Keywords: hiv telerehabilitation biopsychosocial approach
safety & effectiveness of the beam device in mild-to-moderate acne

Conditions: Acne

Summary: this study will determine if the use of the beam device reduces the signs and symptoms of mild-to-moderate acne.


Eligibility criteria:
inclusion criteria: 1. age 15 years or older of either gender and of any racial/ethnic group. 2. at least 8 acne inflammatory lesions (see section 9) in the treatment and control areas. 3. presence of clinically-evident facial acne of mild-to-moderate severity (score 2-4 on the global acne severity scale, see below) 4. subjects must be in generally good health. 5. subjects must be able and willing to comply with the requirements of the protocol. exclusion criteria: 1. oral retinoid use within six months of entry into the study. 2. systemic acne therapies (oral antibiotics) within 2 weeks of entry into the study. 3. topical acne therapies (retinoids, antibiotics) within 1 week of entry into the study. 4. microdermabrasion or superficial chemical peels at the site to be treated within 2 months of entry into the study. 5. subjects with a history of dermabrasion or laser resurfacing at the site to be treated. 6. use of topical lipid absorbing substances (clinac ac) within 1 week of entry into the study. 7. non-compliant subjects. 8. subjects with a significant medical history or concurrent illness/condition which the investigator(s) feel is not safe for study participation. 9. subjects using alcohol-based topical solutions or "exfoliating" agents within 1 week of entry into the study. 10. subjects with a history of very frequent herpes simplex infections of the face or with clinical evidence of active herpes simplex infections. 11. pregnant or nursing females. 12. subjects with known photosensitivity disorders felt by the investigators to preclude safe inclusion in the study. 13. subjects who have a history of significant post-inflammatory hyperpigmentation at the sites of acne lesions.

Keywords: acne
steroid-free versus steroid-based immunosuppression in pediatric renal (kidney) transplantation

Conditions: Kidney Diseases; Kidney Transplantation; Kidney Transplant; Renal Transplantation; Renal Transplant

Summary: over the last 40 years, corticosteroids (steroids) have been an important part of drug regimens used to prevent organ rejection and to maintain the immune health of individuals who have received organ transplants. unfortunately, the negative physical effects of steroids can be severe, especially in children. the purpose of this study is to determine the safety and effectiveness of a steroid-free treatment regimen for children and adolescents who have received kidney (renal) transplants.

corticosteroids (steroids) have been a cornerstone of immunosuppressive therapy for kidney (renal) transplantation for over 40 years. however, poor growth and bone loss caused by the use of steroids are devastating to pediatric kidney recipients. the negative physical implications of steroid use also greatly impacts patients' compliance to their prescribed steroid-containing regimens. the development of a steroid-free regimen for post-transplant pediatric patients is sorely needed. this study will evaluate the safety and efficacy of a steroid-free based treatment regimen in children and adolescents who have received kidney transplants, compared to a standard of care steroid-based regimen. participants in this study will be pediatric patients with end-stage kidney disease who will undergo kidney transplantation at the start of the study. patients will participate in this study for 3 years. participants will be randomized (1:1) to one of two groups. the study includes 23 study visits over 3 years. a physical exam, medication history, adverse events reporting, blood pressure readings, growth assessment, and blood collection will occur at most visits. at the time of transplantation, participants will have a kidney biopsy. participants will also undergo cataract screening within 4 months of transplantation.

Eligibility criteria:
inclusion criteria: * primary recipient of a kidney transplant * meets site-specific transplant criteria * panel reactive antibody (pra) of 20% or less * willing to use acceptable forms of contraception * parent or guardian willing to provide informed consent, if applicable exclusion criteria: * previous treatment with steroids within 6 months prior to transplantation * received en-bloc kidney or other kidney that does not meet protocol-specified requirements * received an organ from an human leukocyte antigen (hla) identical donor or a non-heart-beating donor * received a solid organ other than a kidney * received a bone marrow or hematopoietic stem cell transplant * received a repeat kidney transplant * currently receiving an investigational pharmacologic or biologic agent * human immunodeficiency virus (hiv) infected or infected with another immunodeficiency virus * hypersensitivity to murine products or the study drugs or their formulations * inability to measure height accurately * pregnant or breastfeeding

Keywords: organ rejection corticosteroids child adolescent immunosuppression steroids
prospective collection of female and male specimens for panther® system testing

Conditions: Chlamydia Infections; Gonorrhea

Summary: the objective of this study is to obtain female first-catch urine, vaginal, cervical and endocervical swabs and male first-catch urine and urethral swabs for testing with multiple aptima assays on the gen-probe panther® system


Eligibility criteria:
inclusion criteria: * the subject is at least 16 years of age at the time of enrollment and is currently sexually active (has had intercourse within the past 12 months) * the subject and/or legally authorized representative is willing to undergo the informed consent process prior to study participation (a minor will need the documented consent of his/her parent or legal guardian, unless the site has an institutional review board (irb)-approved waiver for parental consent for minors) in addition, the subject must meet at least one of the following criteria: * the subject reports symptoms consistent with a suspected sti such as abnormal discharge, genital itching, pain/discomfort during sexual intercourse or urination, and/or lower abdominal discomfort * subject is asymptomatic and known to be partners with, or a contact of, a person with a confirmed or suspected sti(s) * subject is asymptomatic and undergoing screening evaluation for possible stis * subject (female) is asymptomatic and undergoing a routine examination with a pelvic examination exclusion criteria: * a potential subject will be ineligible for clinical trial enrollment if the subject, clinician, or medical record reports any of the following: * the subject took antibiotic medications within the last 21 days * subject already participated in this study * subject has a history of illness that the principal investigator (pi) or designee considers could interfere with or affect the conduct, results, and/or completion of the clinical trial * subject has a history of illness that the pi or designee considers could create an unacceptable risk to the subject if enrolled
a study of ati-50002 topical solution for the treatment of alopecia areata

Conditions: Alopecia Areata

Summary: primary: • to assess safety, tolerability and efficacy of 2 dose strengths of ati-50002 topical solution, compared to vehicle in subjects with alopecia areata (aa) secondary: • to evaluate key clinical outcome assessments

primary: • to assess safety, tolerability and efficacy of 2 dose strengths of ati-50002 topical solution, compared to vehicle in subjects with alopecia areata (aa) secondary: • to evaluate key clinical outcome assessments

Eligibility criteria:
inclusion criteria: 1. have a clinical diagnosis of stable patchy alopecia areata (aa) defined as no current areas of spontaneous regrowth. 2. have a severity of alopecia tool (salt) score of at least 15% up to 95% total scalp hair loss determined by the study investigator at baseline. 3. have a duration of the current episode of scalp hair loss of a minimum of 6 months and a maximum of 12 years. 4. if a woman of childbearing potential (wocbp), must have a negative serum pregnancy test at screening (visit 1) and a negative urine pregnancy test at baseline (visit 2) and agree to: use a highly effective method of birth control for the duration of the study; not be planning a pregnancy during the study duration and use contraception for 30 days after last application of study medication. exclusion criteria: 1. females who are nursing, pregnant, or planning to become pregnant for the duration of the study and up to 30 days after the last application of study medication. 2. diffuse alopecia areata. 3. concomitant hair loss disorder (by history or physical exam) such as androgenetic alopecia or scarring alopecia (e.g., cicatricial alopecia, frontal fibrosing alopecia, etc.). 4. active skin disease on the scalp (such as psoriasis or seborrheic dermatitis) or a history of skin disease on the scalp that in the opinion of the investigator would interfere with the study assessments of efficacy or safety. 5. active scalp trauma or other condition affecting the scalp that, in the investigator's opinion, may affect the course of aa or interfere with the study conduct or evaluations. 6. the presence of a permanent or difficult to remove hairpiece or wig that will, in the opinion of the investigator, interfere with study assessments if not removed at each visit.
genetics of schizophrenia

Conditions: Schizophrenia

Summary: genetic etiology in schizophrenia is widely accepted. however, many chromosomal sites were shown to characterize the families of patients with schizophrenia. this is probably due to the high genetic heterogenity of this illness. thus, it is important to investigate the genetic factor in relatively genetically homogenous populations. many studies have indicate that ashkenazy jews show relative gentic homogenity. indeed, the genes responsible for most mendelian disorders of jewish peoples have been identified. the study will apply genome-wide mutation screening methods to identify candidate allells in subjects of ashkenazi jewish ancestry with multiplex schizophrenia.


Eligibility criteria:
inclusion criteria: 1. age 18+; 2. meet dsm-iv criteria for schizophrenia; 3. at least one first-degree relative who meet dsm-iv criteria for schizophrenia; 4. can sign the informed consent form. exclusion criteria: 1. patients suffering from terminal or incurabale disease; 2. minors, incompetents

Keywords: schizophrenia genetics family multiplex haplotypes
study to evaluate pharmacokinetics and tolerability of multiple doses of eslicarbazepine acetate and oxcarbazepine

Conditions: Partial Epilepsy

Summary: this purpose of this study is to measure the concentrations of two anti-epileptic drugs (eslicarbazepine acetate and oxcarbazepine) and their metabolites in the cerebrospinal fluid and blood plasma of healthy subjects and also to assess how these drugs are tolerated.


Eligibility criteria:
inclusion criteria: * healthy subjects * aged 18-55 years * body mass index (18.5-29 kg/m3)

Keywords: partial epilepsy eslicarbazepine acetate pharmacokinetics tolerability
study evaluating paz-417 in cerebrospinal fluid in subjects with alzheimer's disease

Conditions: Alzheimer Disease

Summary: the primary purpose of this study is to assess biomarker known as amyloid beta peptide 40 (ab40) in cerebrospinal fluid (csf), following a single oral dose of paz-417 in subjects with alzheimer disease (ad). this study will also consider another biomarker amyloid beta peptide 42 (ab42) in cerebrospinal fluid in subjects with alzheimer disease and assess the safety, tolerability and pharmacokinetic profile of paz-417 in both plasma and cerebrospinal fluid in these subjects.


Eligibility criteria:
inclusion: 1. men or women of non-childbearing potential, 55 years of age or older with a probable diagnosis of alzheimer's disease (ad), according to the national institute of neurological and communicative disorders and stroke-alzheimer's disease and related disorders association (nincds-adrda) criteria. subjects will have ad that is mild to moderate in severity, as qualified by a score of 12 to 26 on the mini-mental state examination (mmse). woman of non-childbearing potential must be either surgically sterile (hysterectomy and/or oophorectomy) or postmenopausal at least 1 year and must have a negative serum pregnancy test result within 48 hours before administration of test article. sexually active men must agree to use a medically acceptable form of contraception during the study and continue it for 12 weeks after test article administration. 2. body mass index in the range of 18 to 32 kg/m2 and body weight greater than or equal to 50 kg. 3. subjects must be generally healthy, with the exception of ad but may be enrolled with a stable, chronic illness, if it is well controlled and does not interfere with the primary objective of the study. subjects may be included with clinically important deviations from normal limits in medical history, physical examination findings, vital sign measurements, findings on 12 lead electrocardiogram (ecg), or chronic laboratory test results that are associated with stable, well controlled chronic illness. exclusion: 1. any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the test article. 2. any significant unstable or uncontrolled cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease. 3. history of vascular disorders (peripheral, coronary, venous), chronic inflammatory disorders (eg, rheumatoid arthritis), hematologic disorders, or bleeding disorders (eg, hemophilia, idiopathic thrombocytopenic purpura, vonwillebrand disease). 4. history of thrombotic events. 5. presence or history of symptomatic vertigo, significant cardiac valvular disease, congestive heart failure, angina pectoris, significant cardiac arrhythmia, or seizures.