Kornimate/medical-research-clean huggingface dataset:
exercise in people with cystic fibrosis on cftr modulator therapy

Conditions: Cystic Fibrosis

Summary: recently, the treatment of cystic fibrosis (cf) incorporated new modulators/enhancers of the cystic fibrosis transmembrane conductance regulator (cftr). it is thus increasingly important to study the side effects of these drugs, their extrapulmonary effects and possible interaction with other drugs and with exercise. for this purpose, a randomized controlled trial is proposed to determine the effects of a telematic exercise intervention on muscle health, in a group of 48 children and adolescents with cf treated with these new generation cftr modulators. they will be randomly assigned to two groups (exercise and control group). the effect of the intervention will be analysed measuring the variables of muscle health, cardiorespiratory fitness, lung function, body composition, inflammatory biomarkers and mirnas. after completion of the intervention program, adherence to exercise and clinical evolution after one year will be analysed.

specific objectives 1. to determine the effects of a strength exercise intervention in a group of children and adolescents with cystic fibrosis treated with new generation cftr modulators on: (1.i) peripheral muscle strength; (1.ii) respiratory muscle strength; (1.iii) muscle mass and (1.iv) biomarkers of muscle damage. 2. to determine the effects of a strength exercise intervention in a group of children and adolescents with cystic fibrosis being treated with new generation cftr modulators on: (2.i) cardiorespiratory fitness; (2.ii) body composition and (2.iii) lung function. 3. to determine the effects of a strength-based exercise intervention in a group of children and adolescents with cystic fibrosis treated with new-generation cftr modulators on: (3.i) biomarkers of inflammatory status and (3.ii) expression of associated mirnas. 4. to determine the effects of a strength-based exercise intervention in a group of children and adolescents with cystic fibrosis treated with the new generation cftr modulators on the levels of elexaxcaftor/ivacaftor/tezacaftor and their metabolites. 5. to assess the clinical evolution and adherence to exercise after 6 months of the programme in children and adolescents with cystic fibrosis treated with the new generation of cftr modulators.

Eligibility criteria:
inclusion criteria: * patients diagnosed with cf. * patients between 6-20 years of age. * patients receiving treatment with new cftr protein modulating medication * reading, acceptance and signing of the informed consent form. exclusion criteria: * cf patients with symptoms of pulmonary exacerbation during the last four weeks. * with a diagnosis of other cardiorespiratory lung diseases progressing to a symptom of persistent respiratory dysfunction. * cf patients with musculoskeletal alterations that influence assessments. * cf patient who is pregnant during the time of the study * cf patient with cognitive impairment; * cf patient with incomplete dosing of modulator therapy;

Keywords: physical fitness muscle strength resistance training lung funcion
social media use in adolescents admitted to a psychiatric unit

Conditions: Depression; Social Media; Adolescent Behavior

Summary: we will investigate the association between social media use and depression in adolescents admitted to a psychiatric unit and continue to follow their progress after discharge in outpatient clinic services. we expect improvement in their depressive symptoms by modifying social media use and adding a mental health app to further encourage the positive effects of social media.


Eligibility criteria:
inclusion criteria: * participants admitted to inpatient psychiatric unit * kaiser insured participants between 13-17 years of age with parental consent * positive for social media use * english speaking exclusion criteria: * pregnant * non english speaking
the effects of water-only fasting and refeeding on body composition

Conditions: Visceral Obesity; Insulin Resistance

Summary: this observational pilot study will assess the effects of water-only fasting on body composition and insulin resistance

this pilot study will explore the effects of water-only fasting followed by an exclusively whole-plant-food diet free of added salt, oil, and sugar on body composition with a particular focus on visceral adipose tissue (vat). the study will also extend a previous study assessing the effects of fasting and refeeding on homeostatic model assessment of insulin resistance (homa-ir) values and markers of cardiovascular health and inflammation by following participants for an additional 6 weeks.

Eligibility criteria:
inclusion criteria: * any gender * 40-70 years old * fasting plasma glucose \<126mg/dl and/or hemoglobin a1c \<7% * bmi between 25 and 40 kg/m2 * elect and qualify for a water-only fast of at least 10 consecutive days * provide informed consent * internet and computer access * able to return for 6-week follow-up visit exclusion criteria: * active malignancy * active inflammatory disorder including classic autoimmune connective tissue (lupus, sjogrens, anca), multiple sclerosis, and inflammatory bowel disorders (ulcerative colitis, crohn's) * stroke or heart attack within the last 12 months * break water-only fast before 10 days with juice or food. * break water-only fast after 10 days with juice or food before end-of-fast blood draw occurs. * leave center before completing at least 5 days of refeeding * unable to lay still on the back for at least 10 min * abdominal metal implants

Keywords: water-only fasting homa-ir insulin resistance visceral adipose tissue
earset healthy volunteer study

Conditions: Otitis Media

Summary: the study will recruit healthy volunteers to undergo the iontophoresis procedure using the acclarent iontophoresis system with earset (ipses).


Eligibility criteria:
inclusion criteria: * at least 12 months old exclusion criteria: * pregnant or lactating females * subjects with history of sensitivity or reaction to lidocaine, tetracaine, epinephrine, or any hypersensitivity to local anesthetics of the amide type, or any component of the drug solution * significantly atrophic or perforated tympanic membrane * otitis externa * damaged or denuded skin in the auditory canal * electrically sensitive subjects and subjects with electrically sensitive support systems (pacemakers, defibrillators, etc.) * cerumen impaction resulting in a significant amount of cleaning required to visualize the tympanic membrane * evidence of otitis media at day of procedure, or within the past three (3) months prior to procedure.
a study to evaluate the safety and effectiveness of three asoprisnil doses in the treatment of women with endometriosis

Conditions: Endometriosis

Summary: the objective of this study is to determine the safety and effectiveness of three doses of asoprisnil, compared to placebo, in the treatment of women with endometriosis.

endometriosis, the presence of endometrial tissue outside the uterus, is a progressive, estrogen-dependent disease that occurs in menstruating women of reproductive age. although all major endometriosis therapies are effective for the treatment of pain, no single treatment is superior to others in terms of efficacy. the major drawbacks of the current medical therapies are severe side effects such as hot flushes and osteoporosis. the objective of this study is to determine the safety and efficacy of asoprisnil 5, 10, and 25 mg tablets, compared to placebo, administered daily for 12 weeks to women with endometriosis, by assessing whether asoprisnil administration diminishes the pelvic pain, dysmenorrhea, dyspareunia, excessive bleeding, and analgesic use associated with this disease and lessens the subjects' perceived pain symptoms. otherwise healthy women with surgically confirmed endometriosis will be enrolled.

Eligibility criteria:
inclusion criteria: * surgically confirmed endometriosis * history of menstrual cycles between 26 and 32 days * otherwise in good health * age 18-40 years, inclusive * subject had pain graded at screening and day 1 according to a scale suggested by biberoglu and berhman5 in at least one of the following categories: 1. moderate or severe pelvic pain not related to menstruation, or 2. moderate or severe dysmenorrhea, or 3. moderate or severe pelvic tenderness elicited on pelvic examination accompanied by non-menstrual pelvic pain. * subject agrees to double barrier method of contraception exclusion criteria: * any abnormal lab or procedure result the study-doctor considers important * history of undiagnosed uterine bleeding or gynecological disorder * severe reaction(s) to hormone therapy * history of osteoporosis or other metabolic bone disease * subject currently breast feeding

Keywords: pelvic pain dysmenorrhea dyspareunia infertility asoprisnil
impact of the epidemic of covid-19 infection among people living with hiv (sars-cov-2)

Conditions: Virus-HIV; Covid19

Summary: the non-essential and non-urgent follow-up consultations of patients living with hiv were postponed or transformed into "teleconsultation" or exchanges of e-mails between practitioners and patients during covid-19 epidemic. this change in care can have an impact on follow-up and access to treatment for pvvih.

on 16 march 2020, an instruction to postpone "non-urgent" consultations was given to doctors. thus, the non-essential and non-urgent follow-up consultations of patients living with hiv were postponed or transformed into "teleconsultation" or exchanges of e-mails between practitioners and patients. this change in care can have an impact on follow-up and access to treatment for pvvih. in addition, the epidemic itself may have consequences: pvvih may be at greater risk because of their immunosuppression and associated co-morbidities.

Eligibility criteria:
inclusion criteria: * patient followed up for hiv infection in one of the corevih hauts de france centres participating in the study * having communicated an email address * having given their consent to participate in this study * beneficiary subject affiliated or entitled to a social security scheme exclusion criteria: * minor patient * refusal to participate * patient under guardianship
a study to observe the onset of immune-related adverse reactions in patients with non-surgical or renal cell carcinoma (rcc) that has spread

Conditions: Renal Cell Carcinoma; Kidney Cancer

Summary: patients with non-surgical or renal cell carcinoma that has spread who are starting treatment for the first time with yervoy and opdivo in the real world


Eligibility criteria:
inclusion criteria: * patients with unresectable or metastatic renal cell carcinoma who are initiating treatment for the first time with yervoy and opdivo in accordance with the japanese package insert will be included in this pms exclusion criteria: * patients receiving combination therapy with yervoy and opdivo for non rcc indication will be excluded from this pms other protocol defined inclusion/exclusion criteria could apply
a prospective, multicenter, non-interventional, real-world study to characterize changes in molecular markers after three weeks of targeted therapy with oxitinib in egfrm nsclc

Conditions: Non Small Cell Lung Cancer

Summary: to evaluate the characteristics of genetic variationmutations at baseline and 3 weeks after oxitinib treatment in egfrm nsclc

characteristics of egfr gene mutation and efficacy of oxitinib treatment at baseline and after 3 weeks of treatment.to evaluate the mechanism of oxitinib treatment resistance and describe the characteristics of genetic variation associated with oxitinib treatment at baseline and 3 weeks after treatment.

Eligibility criteria:
inclusion criteria: 1. ≥18 years old male or female 2. stage iv metastatic or recurrent non-squamous nsclc that is newly diagnosed, histologically proven and not suitable for radical surgery or radiotherapy (ajcc v8); 3. without prior systemic antitumor therapy including egfr-tki or immunotherapy; 4. egfr positive in blood or tissue tested in local laboratory; 5. sufficient blood samples can be provided for molecular detection; 6. signed informed consent forms are available. exclusion criteria: 1. patients were unable to collect plasma samples at baseline; 2. the egfr mutant status of the patient's blood specimen at baseline has not been verified by the central laboratory; 3. the patient refused subsequent treatment with oxitinib; 4）the investigator determines that may affect the conduct of the clinical study and the judgement of the study results.
early luteal progesterone profile after hcg triggering

Conditions: Infertility

Summary: this pilot-study will help characterize the serum progesterone profiles in ivf patients and correlate progesterone levels to ovarian follicles obtained after stimulation with exogenous gonadotropins.

the early luteal progesterone profile in ivf differs significantly from the progesterone profile of the natural cycle, in which the peak is reached around the time of implantation. with this non-invasive trial investigators wish to further explore the early luteal phase profiles of progesterone and hcg in order to optimize current luteal phase support policies in ivf and hopefully increase ongoing pregnancy rates. stimulation, monitoring, and oocyte pick-up will be performed according to the standard procedure of the clinic. on the day of trigger with 5.000 iu hcg a blood sample will be drawn prior to triggering for subsequent analysis. moreover, all ovarian follicles on each side equal to or above 11 mm will be registered. oocyte pick-up and timing of the trigger bolus will be performed according to the standard procedures of the unit. a total 10 blood samples will be drawn during this trial - please see "blood sampling". blood samples will be collected on the following days for subsequent analysis of lh, e2, hcg and progesterone. all embryos will be cryo-preserved for transfer in subsequent frozen/thaw embryo transfer cycles. primary endpoint serum concentrations of progesterone, lh, e2, and hcg during early luteal phase. secondary endpoints the correlation between follicles ≥ 11 mm and progesterone in early luteal phase data are analyzed using spss version 20 software. all tests are two tailed, and p\<0.05 is considered statistically significant. continuous variables are presented as mean +/- sd and are tested by student's t-test. categorical data are expressed as numbers and compared using the chi-square test.

Eligibility criteria:
inclusion criteria: * ivf patients who meet the following criteria: * freeze all cycle after hcg trigger * age 18 - 38 * body mass index (bmi) \< 28kg/m2 * normal ovarian reserve, defined by anti-mullerian hormone (amh) \> 1.25 ng/ml or antral follicle count (afc) ≥ 6 measured within two months prior to stimulation start * receiving gonadotropin releasing hormone antagonist co-treatment during ovarian stimulation * agreement to participate in the study, and to disclose any medical events to the investigator. the subject must be willing and able to comply with the protocol requirements for the duration of the study. * have given written informed consent with the understanding that the subject may withdraw consent at any time without prejudice to future medical care. exclusion criteria: * previous poor response (≤ 3 oocytes) after high dose fsh stimulation * hyper-response defined as \>20 follicles ≥ 14 mm * chronical medical conditions like diabetes, crohns disease, thyroid disease, hepatitis b and sexually transmitted diseases simultaneous participation in an interventional clinical trial.

Keywords: in-vitro fertilization luteal phase
phase i open-label dose finding study of sgn-35 for cd30 positive hematologic malignancies

Conditions: Lymphoma, Non-Hodgkin; Disease, Hodgkin; Lymphoma, Large-Cell, Anaplastic

Summary: phase i study to define the safety profile and pharmacokinetic parameters of sgn-35 in patients with relapsed/refractory cd30-positive hematologic malignancies. this is a single-arm, open-label, phase i dose escalation study designed to define the mtd, pk, immunogenicity and anti-tumor activity of sgn-35 in patients with relapsed/refractory cd30-positive hematologic malignancies.


Eligibility criteria:
inclusion criteria: * patients must have histologically confirmed cd30-positive hematologic malignancy. * patients with hl must have failed systemic chemotherapy either as induction therapy for advanced stage disease or salvage therapy after initial radiotherapy for early stage disease and were ineligible for, refused treatment by, or previously received stem cell transplant. * patients must have measurable disease of at least 10mm as documented by radiographic technique. * must be at least 18 years of age. exclusion criteria: * patients with current diagnosis of pcalcl (systemic alcl eligible). * patients with history of allogeneic stem cell transplant. * patients who have had previous treatment with any anti-cd30 antibody.

Keywords: antigens,cd30 antibody-drug conjugate antibodies, monoclonal lymphoma, non-hodgkin disease, hodgkin lymphoma, large-cell, anaplastic hematologic diseases lymphoma
gu-01: glycyrrhizin in prostate cancer

Conditions: Prostate Cancer

Summary: this is a pilot, randomized, window-of-opportunity treatment trial in which participants with previously untreated prostate cancer (pca) who are candidates for surgery (radical prostatectomy)

this is a pilot, randomized, window-of-opportunity treatment trial in which participants with previously untreated prostate cancer who are candidates for surgery (radical prostatectomy) will receive one cycle of therapy consisting of glycyrrhizin (gly) (observation, dose level 1 75mg daily, or dose level 2, 150mg daily) for 6 weeks (+/- 2 weeks) prior to surgery.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years of age at time of consent 2. ecog performance status of 0, 1, or 2 3. histologic diagnosis of prostate cancer 4. patient suitable for radical prostatectomy as determined by surgical team 5. able to provide written informed consent and hipaa authorization for release of personal health information, via an approved uic institutional review board (irb) informed consent form and hipaa authorization. 6. willing to use barrier contraceptive method during study intervention exclusion criteria: 1. any prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of this investigational regimen, as determined by the treating urologic oncology team. 2. previous chemotherapy, biological therapy, radiation therapy, androgens, thalidomide, immunotherapy, other anticancer agents and/or investigational agents within 30 days of starting study treatment. 3. potent or moderate inhibitors and inducers of cyp3a4 if taken within a 1 week wash-out period 4. concomitant medications known to prolong qt interval, or with factors that increase the risk of qtc prolongation, or history of torsades de pointes. this may include patients who have sub-optimally controlled hypertension, serum potassium levels \<4.0 meq/l, serum magnesium ≤1.8 mg/dl, prolonged gastrointestinal transit time, or decreased 11-β-hydroxysteriod dehydrogenase-2 activity.
vitamin d deficiency in adolescent girls

Conditions: Healthy; Vitamin D Deficiency

Summary: fibroblast growth factor 23 (fgf23) is a newly discovered hormone which regulates phosphate and vitamin d levels. in this study, we are looking at what the normal levels of fgf23 are in adolescent girls and how these levels vary with other hormonal measurements. we will also be looking at whether vitamin d supplementation in adolescents who are deficient in vitamin d alters the levels of fgf23 and other factors including insulin resistance.

fibroblast growth factor 23 (fgf23) is a newly discovered hormone. its primary function is to regulate phosphate metabolism, which it does both by directly regulating phosphate excretion through the kidney as well as by regulating vitamin d activity. what controls fgf23 levels is still under investigation; potential factors include dietary phosphate intake and vitamin d levels. in this pilot study, we aim to investigate what the normal levels of fgf23 are in healthy girls and how these are related to other measurements of bone and mineral metabolism. since vitamin d deficiency is very common in healthy girls, we expect a subset of the subjects in this study to be vitamin d deficient. we will then randomize these girls to vitamin d repletion or placebo and follow changes in fgf23 levels. vitamin d deficiency has also been implicated in insulin resistance which is a precursor to diabetes. we will therefore also look at changes in insulin resistance with vitamin d repletion.

Eligibility criteria:
inclusion criteria: * healthy girls aged 9-18 years exclusion criteria: * significant cardiac, hepatic, oncologic, or psychiatric disease * a history of malabsorption, kidney stones, hypoparathyroidism, or growth hormone deficiency * pregnancy * diabetes mellitus * bmi\>/= 99th percentile for age and sex * fracture within the preceding 3 months * hypogonadism (no pubertal development by age 12, absence of menarche by age 14) * serum calcium \ 11 mg/dl * radiographic evidence of rickets * use of medications know to affect serum phosphate levels including phosphate-binding antacids, sodium etidronate, calcitonin, excessive doses of vitamin d (\>1000 units per day), excessive doses of vitamin d (\>20,000 units/day), calcitriol, growth hormone, or anti-convulsants. * use of hormonal birth control

Keywords: fgf23 fgf-23 vitamin d vitamin d deficiency insulin resistance healthy volunteers