Kornimate/medical-research-clean huggingface dataset:
health outcomes of teens participating in summer employment immersion programs

Conditions: Pediatric Obesity; Prediabetic State

Summary: this study is a collaboration between investigators and two community partners: a youth employment program and an urban farm. the community partners hire 300+ adolescents for summer jobs at various organizations. approximately 120 adolescents will be employed with the urban farm site. as one component of their program evaluation plan, investigators will evaluate change in bmi of participants. the investigators hypothesize that there will be a reduction in bmi of those participants working at the urban farm site.

the investigators will measure height/weight/bmi of all participants located at the urban farm site. investigators will also collect demographic data as well as other social data (example: food security).

Eligibility criteria:
inclusion criteria: * employed by summer work program at urban farm exclusion criteria: * n/a
massage therapy for self-efficacy in lvad recipients

Conditions: Heart Failure

Summary: this pilot study evaluates the role of massage therapy to improve self-efficacy in patients with advanced heart failure who have recently received a left-ventricular assist device. in addition to usual care, half of the volunteer patients will receive a massage at regular clinic visits and half will not receive any massage.

patients with advanced heart failure who undergo left-ventricular assist device (lvad) implantation may experience notable physical and/or emotional distress associated with this lifestyle-changing procedure. furthermore, these patients are faced with the task of coping with the trauma of surgery, creating new self-care routines, and learning to live with a lifesaving mechanical device that must always be connected to a power source.the immediate weeks and months after lvad implantation are a critical period to lower physical and emotional distress and to influence patient coping and adaptation. in small studies, massage therapy has been increasingly used to improve patient self-efficacy and coping. in this pilot study, we investigate whether regularly scheduled massages delivered in the clinic setting improve self-efficacy and coping in this select patient population.

Eligibility criteria:
inclusion criteria: * capacitated, at least 18 years of age, received lvad implant during last hospital admission exclusion criteria: * incapacitated, non-english speaking, negative pressure isolation, unstable spine, very low serum platelets (\<10,000/ul), received massage in 30 days prior to enrollment

Keywords: left ventricular assist device massage coping self efficacy
use of 2% chlorhexidine cloths reduce surgical site infections

Conditions: Surgical Site Infection

Summary: use of 2% chlorhexidine gluconate cloths pre-operatively and daily post-operatively jaw line to toes will decrease surgical site infections (ssi) by 30% when compared to patients who receive routine standard of care (use of chlorhexidine cloths night before surgery and morning of surgery).

patients undergoing colorectal surgery will be randomized in a 1:1 fashion into two groups. one will be standard of care using 2% chlorhexidine gluconate wipes night before surgery and morning if surgery. the second group will be randomized into the study arm using 2% chlorhexidine gluconate clothes from jaw line to toes night before surgery, morning of surgery and daily post operative. skin cultures will be obtained at time of consent, prior to surgical procedure before surgical scrub and draping, post operative day 4 and at 30 day follow up visit. incision lines will be assessed daily by study staff for signs of surgical site infection utilizing the cdc's 3 definitions of surgical site infections, superficial incisional ssi, deep incisional ssi, and organ space ssi.

Eligibility criteria:
inclusion criteria: * 1. patients \> 18 years old scheduled for a colorectal surgical procedure asa\>2 or pre-operatively hospitalized exclusion criteria: * unable to consent * known allergy to any of the ingredients contained in sage chlorhexidine gluconate cloths * current infection or history of abdominal infections. * patients on chronic steroids or immunosuppressive medications.
very intense radiotherapy-chemotherapy regimen in advanced hnscc

Conditions: Oropharynx Cancer; Oral Cancer; Hypopharynx Cancer; Larynx Cancer

Summary: altered fractionated radiotherapy and concomitant radio-chemotherapy have been shown to be two possibilities for improving efficacy of radiotherapy in locally advanced head and neck carcinomas. in this multicentric study, we tested the hypothesis that accelerated radiotherapy could be delivered concomitantly with conventional high doses of cddp-5fu, aiming to improve both local control and on distant metastases as compared to very accelerated radiotherapy.

patients with a palpable n2b-c or n3 hnscc strictly unresectable were randomized to receive either accelerated rt-ct delivering to the primary tumor 62-64 gy / 5 weeks in 31-32 fractions of 2 gy bid or very accelerated rt delivering 62-64 gy in 31-32 fractions of 2 gy bid and 22-23 days. in the accelerated rt-ct arm, 3 cycles of cddp 100 mg/m2 were delivered at day 1, 16, 32 and 2 cycles of 5 fu 1000 mg/m2 day 1 to 5 and 31 to 35. one month after completion of the concomitant rt-ct, 2 additional cycles of cddp-5fu were given in patients responding (\> 50%) to the initial course of rt-ct. the end points were event free survival and survival.

Eligibility criteria:
inclusion criteria: * palpable n2b-c or n3 (uicc 1997) squamous cell carcinoma of the head and neck (oropharynx, oral cavity, hypopharynx or larynx) * primary tumor and / or nodal extension strictly inoperable due to the extension of the disease * performance status of 0 to 2 (who scoring system) * renal/liver/cardiac functions and blood counts compatible with the use of cddp and 5-fu * signed inform consent exclusion criteria: * distant metastasis * previous history of cancer * previous radiotherapy or chemotherapy

Keywords: head and neck squamous cell carcinoma radiotherapy chemotherapy
study to compare pt007 to placebo mdi and open-label proventil® hfa in adult and adolescent subjects with asthma

Conditions: Asthma

Summary: this is a randomized, double-blind, single-dose, placebo-controlled, 5-period, 5-treatment, crossover, multi-center study to assess the bronchodilatory effect and safety of 2 dose levels of albuterol sulfate pressurized inhalation suspension (hereafter referred to as as mdi), 90 μg and 180 μg, compared with placebo for as mdi (hereafter referred to as placebo mdi) and open-label proventil® hydrofluoroalkane (hfa; hereafter referred to as proventil) 90 μg and 180 μg in adult and adolescent subjects with mild to moderate asthma. this study design utilizes 10 treatment sequences.

this is a 5-period crossover study. each treatment period is 1 day. subjects will receive a single dose of randomized study drug at each of the 5 treatment visits (visits 2, 3, 4, 5, and 6), with a 3- to 7-day washout period between treatment visits.

Eligibility criteria:
inclusion criteria * are at least 12 years of age and no older than 65 years * have stable (for 6 months) physician-diagnosed asthma with historical documentation of the diagnosis * must be receiving 1 of the following required inhaled asthma therapies listed below for at least the last 30 days; only saba, which is used as needed for rescue, or low to medium doses of ics (alone or in combination with laba), used regularly as maintenance asthma therapy * demonstrate acceptable spirometry performance (ie, meet american thoracic society \[ats\]/european respiratory society \[ers\] acceptability/repeatability criteria * pre-bronchodilator fev1 of ≥40 to \<90% predicted normal value after withholding saba for ≥6 hours * confirmed fev1 reversibility to ventolin, defined as a post-ventolin increase in fev1 of ≥15% * only 2 reversibility testing attempts are allowed exclusion criteria: * chronic obstructive pulmonary disease or other significant lung disease (eg, chronic bronchitis, emphysema, bronchiectasis with the need of treatment, cystic fibrosis, or bronchopulmonary dysplasia) * oral corticosteroid use (any dose) within 6 weeks * current smokers, former smokers with \>10 pack-years history, or former smokers who stopped smoking \<6 months (including all forms of tobacco, e-cigarettes \[vaping\], and marijuana) * life-threatening asthma as defined as any history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s) * historical or current evidence of a clinically significant disease * cancer not in complete remission for at least 5 years * hospitalized for psychiatric disorder or attempted suicide within 1 year * unable to abstain from protocol-defined prohibited medications during the study
tepotinib hepatic impairment trial

Conditions: Hepatic Impairment

Summary: the study investigated the effect of various degrees of hepatic impairment on the pharmacokinetics (pk), safety and tolerability of tepotinib.


Eligibility criteria:
inclusion criteria: * men and women (of nonchildbearing potential), with a body mass index of 18 to 36 kilograms per meter square (inclusive) and a body weight greater than or equal to 50 kilograms at screening, with the absence of acute hepatitis or human immunodeficiency virus 1 and 2, who gave informed consent and are willing and able to comply with study procedures were eligible for enrollment * participants with impaired hepatic function (child-pugh class a or child-pugh class b) and participants with normal hepatic function were eligible to enroll in the study * other protocol defined inclusion criteria could apply exclusion criteria: * healthy participants were excluded if they have hepatitis b or c or had a previous infection with hepatitis c treated with sofosbuvir or other antiviral compounds, or any other clinically relevant disease, as considered by the investigator * participants with impaired hepatic function were excluded if they have primary biliary liver cirrhosis, nonstabilized chronic heart failure, hepatocarcinoma, hepatic encephalopathy (grade iii or iv), sepsis or gastrointestinal bleeding, or any other clinically relevant disease, as considered by the investigator * other protocol defined exclusion criteria could apply

Keywords: hepatic impairment tepotinib pharmacokinetics
cross over study to prove bioequivalence between two brands of cefalexin suspension

Conditions: Anti-Infective Agents

Summary: a single dose, two treatments (two cephalexin suspension brands), two sequences, cross-over design was used with a washout of 7 days between the two study periods. treatment groups balanced with the same number of healthy volunteers who were randomly (in two strata: male and female) assigned to the study drug administration sequences


Eligibility criteria:
inclusion criteria: * healthy male or female volunteers age between 18 and 55 years old with normal vital signs, electrocardiogram (ecg), blood chemistry, liver function profile and urinalysis exclusion criteria: * history of illnesses or any organic abnormalities that could affect the results of the study * history of abuse tobacco or alcohol or regular use of recreational or therapeutic drugs * subjects that have taken any medication within 14 days or that are in an elimination period of less than 7 half-lives (whichever is longest) before study startup.
safety, tolerability, pharmacokinetic and pharmacodynamic study of ski2670

Conditions: Endometriosis

Summary: in this phase i study, the primary objective is to investigate the safety and tolerability of ski2670 after oral administration in healthy female subjects. and secondary objective is to investigate the pharmacokinetics and pharmacodynamics of ski2670 after oral administration in healthy female subjects.

in this phase i study, the primary objective is to investigate the safety and tolerability of ski2670 after oral administration in healthy female subjects. secondary objective is to investigate the pharmacokinetics and pharmacodynamics of ski2670 after oral administration in healthy female subjects.

Eligibility criteria:
inclusion criteria: 1. female, 20 years of age and older 2. weight between 40kg\~70kg 3. women who agreed using double contraception method and spermicide, avoiding breast-feeding for at least 30days after ip(investigational product) dosing 4. a history of regular menstrual cycles (cycle: 28±7day, duration: 2\~7day) for at least 2 years and a positive ovulation test between day 11 and 21 in the preceding menstrual cycle of ip(investigational product) dosing exclusion criteria: 1. women who are pregnant or serum/urine hcg(human chorionic gonadotropin) positive or breast-feeding 2. a history of breast cancer, genital cancer or any estrogen dependent tumor 3. specified or unspecified diagnosed infertility or history of natural abortion over three times 4. a history of taking other investigational product within 60days before screening visit or taking etc drug(ethical drugs), oriental medicine or otc drugs(over-the-counter drugs) within 14days before screening visit 5. clinically significant gynecological disease identified by ultrasonography including estrogen dependent tumor or lesion, sever inflammation or synechia 6. ast(aspartate aminotransferase), alt(alanine aminotransferase) ≥ 2.5 times the upper limit of normal 7. qtc \> 450ms on electrocardiogram result
a umbrella study in r/r ptcl guided by molecular subtypes

Conditions: Peripheral T Cell Lymphoma

Summary: this is a multicenter, prospective, open-label, interventional umbrella study to evaluate the efficacy and safety of targeted therapies guided by molecular subtypes in patients with relasped or refractory peripheral t-cell lymphoma.


Eligibility criteria:
inclusion criteria: 1. histologically-confirmed peripheral t-cell lymphoma (without central nervous system involvement) 2. relapsed or refractory disease after first line treatment 3. availability of archival or freshly collected tumor tissue before study enrollment 4. evaluable lesion by pet-ct or ct scan 5. eastern cooperative oncology group (ecog) performance status of 0, 1, or 2 6. life expectancy greater than or equal to (\>/=) 3 months 7. informed consent exclusion criteria: 1. patients with central nervous system (cns) lymphoma 2. history of malignancies except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix 3. uncontrolled cardio- and cerebro-vascular disease, blood clotting disorders, connective tissue diseases, serious infectious diseases and other diseases 4. laboratory measures meet the following criteria at screening (unless caused by lymphoma): neutrophils\<1.0×10\^9/l platelets\<75×10\^9/l (platelets\<50×10\^9/l in case of bone marrow involvement) alt or ast is 2.5 times higher than the upper limits of normal (uln), akp and bilirubin are 1.5 times higher than the uln. creatinine is 1.5 times higher than the uln. 5. hiv-infected patients 6. active hepatitis infection 7. patients with psychiatric disorders or patients who are known or suspected to be unable to fully comply with the study protocol 8. pregnant or lactation 9. other medical conditions determined by the researchers that may affect the study for t3.2 should exclude patiens with active autoimmune disease
early biomarkers of tumor response in high dose hypofractionated radiotherapy word package 3 : immune response

Conditions: Carcinoma, Hepatocellular; Colorectal Neoplasms; Melanoma; Kidney Neoplasms

Summary: this study will follow-up immune cell populations, secreted factors and released nanovesicles in the blood before, during and after high dose radiation therapy which should give new information of the efficacy of the hypofractionated high dose radiation therapy and a rationale for adjuvant immunotherapy.

* patient information and collection of a signed informed consent form * clinical data collection * blood samples of 35 ml: 1. after registration, prior to the first fraction of radiotherapy 2. within 15 minutes after the administration of the 1st, the 2nd and the 3rd radiotherapy sessions 3. one week, 3 months, 6 months, 9 months and 12 months after the last radiotherapy session * storage of the blood samples at ambient temperature * transportation of the samples to the institute of biology of lille (ibl) - cnrs umr8161 for analysis * destruction of the samples at the end of the analysis

Eligibility criteria:
inclusion criteria: * patient requiring a hypofractionated irradiation (≥ 3 fractions, dose ≥ 9 gy per fraction) either for : * hepatocellular carcinoma or hepatic lesion of metastatic colorectal cancer, * metastasis from melanoma or renal cancer, * age ≥ 18 years old, * registered with a social security system, * signed written informed consent. exclusion criteria: * patient treated by chemotherapy, targeted or immunotherapy within 21 days before the first sampling, * pregnant or breastfeeding woman, * patient under guardianship or tutorship.

Keywords: liver metastases of colorectal cancer metastases of melanoma or renal cancer
advanced pelvic floor training program for prostate cancer surgery

Conditions: Prostate Cancer Patients Undergoing Radical Prostatectomy

Summary: radical prostatectomy is a common and effective treatment for prostate cancer but is associated with urinary incontinence that can persist for several months after surgery and significantly reduce quality of life. studies have shown that routine performance of pelvic floor exercises after radical prostatectomy can aid in the recovery of urinary control; however, conventional pelvic floor exercises do not produce consistent results. research indicates that incorporating other deep abdominal muscles can further activate the pelvic floor making it stronger than by activating the pelvic floor alone. specifically, 'pfilates' and 'hypopressives' are two new techniques that combine traditional pelvic floor exercises with activation of supportive muscles. our proposed study will be the first to test the effect of an advanced pelvic floor exercise training program that includes pfilates and hypopressives to treat urinary incontinence following radical prostatectomy. our primary aim of this study is to assess the feasibility of conducting a full-scale rct of an advanced pelvic floor exercise training program, including standard pelvic floor exercises, pfilates, and hypopressives techniques on urinary incontinence. feasibility will be determined by measuring recruitment success, retention, outcome capture, and intervention adherence, tolerance, and safety. we hypothesize men under going radical prostatectomy for prostate cancer in the advance pelvic floor training program will report greater improvement in urinary incontinence and health-related quality of life.


Eligibility criteria:
inclusion criteria: * men with localized prostate cancer (stage ct1-ct2) who have consented for radical prostatectomy (open retropubic, laparoscopic, robot-assisted laparoscopic) * between the the ages of 40 and 80 years * proficient in english exclusion criteria: * i) diagnosed with a known neurological disease, autoimmune connective tissue disorder; * ii) have prior experience with pelvic floor training by a healthcare provider; * iii) have uncontrolled hypertension; * iv) have diagnosed copd (chronic obstructive pulmonary disease) and/or chronic restrictive respiratory disease; or * v) have a history of inguinal herniation

Keywords: prostate cancer radical prostatectomy pelvic floor muscle exercises pfilates hypopressives urinary incontinence
effective implementation of interpersonal psychotherapy

Conditions: Depressive Symptoms

Summary: the study is designed to observe the impact of improved measures of the fidelity on the community delivery of interpersonal psychotherapy. pairs of therapist-patient dyads will be observed, first to develop and test brief measures of fidelity, and then to correlate those measures with symptomatic outcomes.

the study is designed to observe the impact of improved measures of the fidelity on the community delivery of interpersonal psychotherapy. in phase i, 250 pairs of therapist-patient dyads will be observed as ipt fidelity measures are developed and validated. in phase ii, 175 pairs of therapist-patient dyads will be observed to prospectively validate the ipt fidelity measures with longitudinal outcomes on the phq-9.

Eligibility criteria:
inclusion criteria: * age 18-99 * diagnosis of depressive disorder * being treated with ipt in community settings exclusion criteria: - none
iontophoresis with potassium iodide and thyroid function

Conditions: Thyroid Dysfunction

Summary: the aim of the study: to assess the influence of iontophoresis treatment with 2% potassium iodide on the level of thyroid hormones (tsh, ft3, ft4) the study group: conducting 10 iontophoresis treatments with potassium iodide; the control group: conducting 10 placebo treatments with iontophoresis with destilled water; intervention: 10 iontophoresis treatments with 2% potassium iodide in healthy individuals. test the level of thyroid hormones before and after the 10 iontophoresis treatments; the study allows to assess the influence of iodine on the function of thuroid gland.


Eligibility criteria:
inclusion criteria: * healthy individuals with normal thyroid function exclusion criteria: * individuals with thyroid disorders, * taking thyroid medication, * using drugs, alcohol, cigaretttes

Keywords: iontophoresis potassium iodine thyroid
exercise training to improve cardiopulmonary hemodynamics in heart failure patients

Conditions: Heart Failure; Pulmonary Hypertension

Summary: this research study is being done to find out if exercise therapy can help improve the heart function, overall health, and quality of life of patients with pulmonary hypertension caused by heart failure.

the purpose of this research is to see if taking part in structured exercise training will improve the ability to exercise, the function of the heart, and the function of the blood vessels that supply the lungs in patients with heart failure and pulmonary hypertension. after enrollment all patients will complete exercise testing. patients will be randomized to either 10 weeks of exercise training (3 times per week) or will continue standard medical care. all patients will undergo detailed exercise testing before and after the intervention.

Eligibility criteria:
inclusion criteria: * nyha functional class i-iiib. * lvef \< 40%. * clinically-stable for \> 3 months \[no change in disease status or medication\]. * willing and able to provide written informed consent and perform cycle-ergometer or treadmill based exercise. exclusion criteria: * nyha class iv hf. * diagnosis of diastolic hf. * comorbidities such as obesity (bmi \>36), uncontrolled systemic hypertension, type 2 diabetes, and copd (fev1 \<50%). * musculoskeletal or other conditions that would limit exercise participation. * pregnant or nursing women

Keywords: exercise training right ventricle exercise capacity quality of life