Kornimate/medical-research-clean huggingface dataset:
skin protectant textile efficacy study for managing skin fold conditions

Conditions: Erythema; Maceration; Lesion Skin; Skin Folds

Summary: this study will evaluate the efficacy of the drigo skin protectant textile (spt) to manage erythema, maceration, denudation, satellite lesions, pain, itching, burning, moisture, and odor associated with skin folds (henceforth together referred to as "skin fold conditions"). participants will be patients with skin fold conditions, which will be treated with the spt. healthcare providers will apply the spt to the participants' target areas. a given participant can have up to two target areas enrolled in the study. an independent licensed clinician with experience in identifying and treating skin fold conditions, will use photographs of the skin folds and other skin-on-skin contact areas (henceforth referred to as "target area\[s\]") to assess the status of erythema, maceration, denudation, and satellite lesions in the target areas when the spt is first applied (day 0), and on days 1, 3, and 5, during spt changes. the principal investigator (pi) or qualified designee will take photographs of the target areas and assess moisture and odor in these areas. participants will provide their impressions of pain, itching and burning in the target area(s) on the same days as the skin fold condition photography. in addition, the study will include feedback from the health care providers (hcps) about the spt and overall experience of the participants with the spt.


Eligibility criteria:
inclusion criteria: * individuals ≥ 18 years of age. * individuals who have evidence of one or more of the following skin fold conditions: erythema, maceration, denudation, satellite lesions, pain, itching, burning, moisture, and odor. * individuals whose treatment plan permits assessment of the skin fold condition(s) for up to six days. exclusion criteria: * individuals whose target area(s) are being managed with topical treatments such as antibiotics, antifungals, ointments including skin protectants, anti-itch products, anoperineal dressings or absorbent pads (eg, ard®). * individuals with a known allergy or sensitivity to the ingredients in the spt, such as the fabric or h2o2, as well as the tape that may be used to secure the spt.
effect of momordica charantia administration on type 2 diabetes mellitus, insulin sensitivity and insulin secretion

Conditions: Diabetes Mellitus Type 2

Summary: the hypoglycemic effect of momordica charantia has been evaluated in clinical trials in patients with type 2 diabetes mellitus. important reductions in fasting plasma glucose, glycated hemoglobin (a1c), and fructosamine were observed. it is unknown whether this improvement is due to an improvement in insulin sensitivity and insulin secretion. the purpose of this study is to evaluate the effect of the administration of momordica charantia on insulin sensitivity and insulin secretion in patients with type 2 diabetes mellitus.

a randomized, double-blind, placebo controlled clinical trial is carried out in 24 patients with diagnosis of diabetes mellitus type 2 according to the criteria of the american diabetes association. patients are assigned to two different arms: one group receives momordica charantia, 2 capsules with 500 mg twice daily before breakfast and dinner for 90 days or placebo, under the same scheme of treatment. an oral glucose tolerance test is performed before and after the intervention. matsuda index, stumvoll index and insulinogenic index are calculated to assess insulin sensitivity and insulin secretion. other clinical and laboratory parameters that are evaluated include: body weight, body mass index, waist circumference, blood pressure, body fat percentage, fasting plasma glucose, a1c, creatinine, lipid profile and liver transaminases.

Eligibility criteria:
inclusion criteria: * diagnosis of diabetes mellitus type 2 according to the criteria of the american diabetes association (\<5 years), without pharmacological treatment (oral antidiabetic drugs or insulin) at least for three months before entering the study * fasting glucose: \<210 mg/dl * a1c: 7-9% * body mass index: 25-34.9 kg/m2 * body weight without variations above or under 5% in the last three months before entering the study * women in childbearing years must have a contraceptive method * letter of consent and release signed by each patient exclusion criteria: * pregnant or suspected pregnant women * woman breastfeeding * medications known to affect metabolism of glucose and insulin * personal history of liver or renal disease * hypertension, thyroid or cardiovascular disease decompensated * total cholesterol \>= 240mg/dl, triglycerides \>=400mg/dl, glomerular filtration rate \ =2.5 the upper normal limit

Keywords: momordica charantia insulin secretion insulin sensitivity
respiratory muscle stretching exercise for improving quality of life of patients with bronchiectasis

Conditions: Bronchiectasis Post-Tuberculosis Lung Disease

Summary: bronchiectasis is a chronic condition often arising after the successful treatment of lung tuberculosis, leading to diminished functional exercise capacity, increased fatigue, and reduced quality of life. this randomized controlled trial aims to evaluate the efficacy of adding respiratory muscle stretching (rms) exercises to standard pulmonary rehabilitation in improving functional exercise capacity, reducing fatigue, and enhancing the quality of life in patients with bronchiectasis post-tuberculosis.

bronchiectasis, a long-term sequelae of lung tuberculosis, is characterized by permanent dilation and damage of the bronchi, resulting in reduced lung function, persistent fatigue, and significantly impaired quality of life. standard pulmonary rehabilitation (pr) programs, which include aerobic exercises and breathing techniques like pursed lip breathing (plb) and the active cycle of breathing technique (acbt), are known to offer symptomatic relief and functional improvements. however, the role of respiratory muscle stretching (rms) in this context has not been well explored. this clinical trial will assess the impact of rms, when combined with standard pr, on key outcomes including functional exercise capacity, fatigue, and overall quality of life in patients with bronchiectasis following tuberculosis treatment. the study will involve a parallel assignment of patients to either the standard pr group or the pr plus rms group, with outcomes measured over a 6-week intervention period. the primary endpoints will include changes in 6-minute walk test (6mwt) distances, fatigue severity scale (fss) scores, and quality of life (st. george's respiratory questionnaire) scores.

Eligibility criteria:
inclusion criteria: * age 18-59 years * history of lung tb treatment * clinical or radiological diagnosis of bronchiectasis * mmrc dyspnea scale grade 1-3 exclusion criteria: * pneumothorax pleural effusion * neuromuscular disease * lung malignancy * history of covid-19
this study compared an in home asthma management program provided by nurses or respiratory therapist

Conditions: Asthma

Summary: this study compared an in-home asthma management program provided by nurses or respiratory therapists to see if those receiving program had fewer hospitalizations, clinic and emergency room visits and higher levels of satisfaction and health related quality of life.

background: disease management may improve outcomes and reduce cost. we compared an in-home asthma management program (amp) delivered by respiratory therapists (rts) or nurses (rns) to standard care (sc) in 159 adults with moderate to severe asthma to determine the effect on health care utilization (hcu), patient satisfaction (ps) and health related quality of life (hrqol). methods: this single center, prospective trial randomized subjects, age 18-64, to three groups: sc, amp-rt or amp-rn. outcomes at six-months were hcu, cost, pulmonary function, symptoms, environmental assessment, asthma self-management, hrqol (sf-36; st. georges respiratory questionnaire \[sgrq\]) and ps. frequencies were compared using chi 2; all other variables were compared using anova with a post-hoc test.

Eligibility criteria:
inclusion criteria: * adult patients (age 18-64 years) treated in the ed or hospitalized for an acute exacerbation of asthma at the university teaching hospital were invited to participate. exclusion criteria: * included other pulmonary disorders or diagnosis of co-morbid disease which was disabling in nature.

Keywords: asthma management cost disease management respiratory care nursing health care utilization health related quality of life
exercise for women with peripheral arterial disease

Conditions: Peripheral Artery Disease; Claudication; Women

Summary: hypothesis #1. supervised exercise rehabilitation will result in greater increases in exercise performance, peripheral vascular function, and health-related quality of life than compared to the attention-control group. hypothesis #2. the change in peripheral vascular function will be predictive of improved exercise performance following the supervised exercise program.


Eligibility criteria:
inclusion criteria: * women 60 years of age and older having a positive history of intermittent claudication assessed by the san diego claudication questionnaire * exercise limited by intermittent claudication during a screening treadmill test using the gardner protocol * an ankle/brachial index (abi) \< 0.90 at rest or \< 0.73 immediately following the treadmill exercise test * at least one year past menopause exclusion criteria: * absence of pad (peripheral artery disease) * asymptomatic pad (fontaine stage i) * rest pain due to pad (fontaine stage iii) * tissue loss due to pad (fontaine stage iv) * medical conditions that are contraindicative for exercise according to the american college of sports medicine (e.g., acute myocardial infarction, unstable angina, etc.) * use of medications indicated for the treatment of intermittent claudication (cilostazol and pentoxifylline) initiated within three months prior to investigation) * cognitive dysfunction (mini-mental state examination score \< 24) * active cancer, renal disease, or liver disease * a calf skin fold measurement \> 50 mm, because of potential interference with the light path of the near-infrared spectroscopy probe from penetrating the subcutaneous tissue * pulse arterial oxygen saturation of the index finger \< 95% because of the potential deleterious effect on calf muscle sto2 from poor pulmonary gas exchange
femaseed local artificial insemination trial

Conditions: Infertility; Male Factor

Summary: brief summary: the objectives of the trial are to evaluate the safety and effectiveness of the femaseed localized directional insemination for artificial insemination, now known as the femaseed intratubal insemination since fda cleared under k231730 in september 2023.

314 subjects enrolled (signed inform consent) inclusive of 188 subjects in protocol versions 1-4 and 126 subjects in protocol version 5 (including re-consented subjects).

Eligibility criteria:
inclusion criteria: 1. female, 19-40 years of age, with no tubal, uterine or ovarian infertility factor (including patent fallopian tubes with no evidence of hydrosalpinx) exclusion criteria: 1. greater than three prior intrauterine insemination (iui) cycles 2. current or recent (within the last 3 months) pelvic infection (cervix, endometrium, or fallopian tubes) 3. prior history of ectopic pregnancy or tubal surgery

Keywords: infertility iui intrauterine insemination unexplained male sperm
the neuroendocrine effects of pioglitazone in patients with cancer and cachexia

Conditions: Lung Cancer

Summary: the goal of this clinical trial is evaluate the effect of pioglitazone compared with placebo on skeletal muscle insulin sensitivity in subjects with cancer and cachexia.


Eligibility criteria:
inclusion criteria: * age ≥18 years * documented histologic or cytologic diagnosis of non-small-cell lung cancer or gastrointestinal cancer that is locally advanced and inoperable or metastatic (e.g., spread to distant organs) * cachexia defined by fearon criteria * insulin resistance syndrome, defined with the homeostatic model assessment for insulin resistance (homa-ir) * ability to provide written informed consent, willing and able to comply with all scheduled visits, treatment plans, laboratory tests, and other study procedures * provide written approval by a qualified healthcare professional * allow the collection and storage of biospecimens and data for future use exclusion criteria: * prior diagnosis of type 2 diabetes * prior or current thiazolidinedione (tzd) therapy * known hypersensitivity to tzd * new york heart association (nyha) class i-iv heart failure * history of or actively treated bladder cancer * current use of cyp2c inhibitor (e.g., gemfibrozil) or cyp2c inducer (e.g., rifampin) * inadequate hepatic function * currently pregnant, breastfeeding, or planning to become pregnant within the next 16 weeks * contraindications to magnetic resonance imaging (e.g., implanted cardiac device, cochlear implant) * any other condition that, in the investigator's opinion, would preclude participation or successful compliance with the protocol
letrozole in metastatic breast cancer in combination with chemotherapy

Conditions: Metastatic Breast Cancer

Summary: therapeutic interventions for patients with metastatic breast cancer are aimed at prolonging survival and improving the quality of life. the objective of this trial is to assess if an initial chemotherapy followed by an endocrine therapy leads to a longer disease-free interval as compared to chemotherapy alone.


Eligibility criteria:
inclusion criteria * histologically proven metastatic breast cancer * measurable disease, patients with bone only disease are not eligible * age ≥ 65 years * performance status ≤ 2 (world health organization) * estimated life expectancy under therapy of at least 3 months * estrogen-/progesterone-receptor status positive or unknown * signed informed consent exclusion criteria * prior chemo- or hormone therapy for metastatic breast cancer; prior therapy with aromatase inhibitors in the adjuvant setting * disease-free interval after adjuvant therapy \< 1 year * clinical signs of central nervous system metastases * renal, bone marrow, or liver insufficiency * severe coronary heart disease, cardiac insufficiency or other severe concomitant internal diseases * pulmonary fibrosis/alveolitis additional protocol-defined inclusion/exclusion criteria may apply.

Keywords: metastatic breast cancer aromatase inhibitor letrozole
immunogenicity & safety of gsk's combined dtpa-hbv-ipv/hib vaccine in indian infants at 2 diff vaccination schedules

Conditions: Diphtheria; Acellular Pertussis; Tetanus; Haemophilus Influenzae Type b; Hepatitis B; Poliomyelitis

Summary: in this study, infants who were previously vaccinated with hepatitis b vaccine at birth will be randomly allocated into two groups: * one group of subjects will receive diphtheria, tetanus, acellular pertussis- hepatitis b virus-inactivated poliovirus/haemophilus influenzae type b (dtpa-hbv-ipv/hib) vaccine at 6-10-14 weeks of age * the second group of subjects will receive dtpa-hbv-ipv/hib vaccine at 2-4-6 months of age

dtpa-hbv-ipv/hib vaccine will be administered at two schedules (i.e. 6-10-14 weeks of age or 2-4-6 months of age) in infants who were previously vaccinated with hepatitis b vaccine at birth. the duration of the study will be approximately 3 months for each subject who will receive vaccination at 6-10-14 weeks of age and approximately 5 months for each subject who will receive vaccination at 2-4-6 months of age. intervention name: diphteria, tetanus, acellular pertussis, hepatitis b, poliovirus types 1, 2, 3 \& haemophilus influenzae type b vaccine

Eligibility criteria:
inclusion criteria: * a healthy male or female infant between, and including, 6 to 10 weeks of age at the time of the first vaccination. * written informed consent obtained from the parent or guardian of the subject. * born after a normal gestation period (between 36 and 42 weeks). * should have received a birth dose of hepatitis b vaccine, as evidenced by vaccination/immunisation certificate. exclusion criteria: * use of any investigational or non-registered product (vaccine or drug) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period. * chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs prior to the first vaccine dose. * any chronic drug therapy to be continued during the study period. * planned administration/administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the administration of the first vaccine dose and ending 30 days after the last dose (with the exception of oral polio vaccine as a birth dose or for a pulse polio program, as per local, regional, or national requirements). * previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis and haemophilus influenzae type b diseases. * known exposure to diphtheria, tetanus, bordetella pertussis, hepatitis b, poliomyelitis and haemophilus influenzae type b diseases since birth.

Keywords: diphtheria tetanus poliomyelitis pertussis hepatitis b prophylaxis haemophilus influenza type b diseases
a multicenter trial to investigate the efficacy and safety of tolvaptan in patients with hyponatremia in siadh

Conditions: Syndrome of Inappropriate Antidiuretic Hormone Secretion

Summary: the objective of this study is to investigate the efficacy and safety of tolvaptan based on the change in serum sodium concentration following administration of tolvaptan oral tablets at 7.5 to 60 mg/day for up to 30 days in patients with hyponatremia in the siadh.


Eligibility criteria:
inclusion criteria: * subjects with a definite diagnosis of siadh in reference to "diagnostic and treatment manual of the hypersecretion of vasopressin (siadh), revised in 2011" * subjects who have been on fluid restriction for at least 7 consecutive days at the time of informed consent and who are showing no improvement of hyponatremia at the time of the screening examination exclusion criteria: * subjects who have transient hyponatremia induced by drug administration * subjects who are unable to sense thirst or who have difficulty with fluid intake * subjects with urinary tract obstruction * subjects who have participated in any other clinical trial within 30 days prior to informed consent * subjects with serum sodium concentration of \<120 meq/l associated with neurologic impairment, including apathy, confusion, or seizures
a study of metabolic agents following brain radiation

Conditions: CNS Malignancy

Summary: this study is being done to determine if cest magnetic resonance imaging (mri) and fdg pet are feasible techniques to detect metabolic differences between tumor and brain in patients with a brain tumor.


Eligibility criteria:
inclusion criteria: * radiographic evidence or histopathologic confirmation of cns malignancy, with or without prior resection. * provide written informed consent for the current study. * willing to undergo at least one mri (and possibly more at pi discretion) with proton and/or phosphorus magnetic resonance spectroscopy analysis. exclusion criteria: * vulnerable populations: pregnant or nursing women (arm b exempt), prisoners, mentally handicapped. * cardiac pacemaker or artificial heart valve * metal plate, pin, or other metallic implant * intrauterine device, such as copper-7 iud * insulin or other drug pump * non-titanium aneurysm clips * previous gunshot wound * cochlear implant or other hearing device * employment history as a metalworker (had metal in eye) * permanent (tattoo) eye-liner * for fdg-pet specifically: fasting blood sugar level greater than 200mg/dl
study of azasite (azithromycin) versus vigamox in the conjunctiva of healthy volunteers

Conditions: Bacterial Infections; Eye Infections

Summary: the purpose of this study is to evaluate the drug concentrations of azasite™ compared to vigamox at various time points in conjunctiva tissue of healthy volunteers


Eligibility criteria:
inclusion criteria: * have best corrected visual acuity of 0.60 logmar or better in each eye as measured using early treatment of diabetic retinopathy study chart exclusion criteria: * have a known allergy and/or sensitivity to the test article(s) or its components or any therapies associated with the trial * have active signs or symptoms of any clinically significant ocular disorder (other than refractive disorders) * have a known bleeding disorder or history of bleeding complications after surgical or dental procedures * take aspirin, or take any other blood thinners or anti-coagulants (e.g. warfarin) including prescription, over the counter, or homeopathic therapies * have undergone any ocular surgical intervention within 3 months prior to visit 1 or anticipate having ocular surgery during the study
an open-label, safety and tolerability study of chronic intermittent use of diazepam nasal spray.

Conditions: Epilepsy

Summary: this study will assess long-term safety and tolerability of repeat dose diazepam nasal spray in adolescents and adults with cluster seizures, with a focus on potential local effects (changes in nasal mucosa, olfaction, and taste).


Eligibility criteria:
inclusion criteria: * diagnosis of drug-resistant epilepsy * patients who experience multiple episodes of acute repetitive seizures requiring at least one concomitant antiepileptic drug (aed) * occurrence of at least 3 seizure clusters within the past 12 months, including at least one cluster in the 4 months prior to the screening visit * a caregiver must consent to participate together with the subject for purposes of observation and data collection * the caregiver must be present when the investigational product is administered * screening body weight between 26 to 111 kg, inclusive exclusion criteria: * female subject who is pregnant, breastfeeding, or planning to become pregnant * presence or history of any abnormality or illness that may affect the absorption, distribution, metabolism or elimination of diazepam * known allergy or hypersensitivity to diazepam, related drugs, or any of the formulation components * positive screening test for ethanol or other drugs of abuse * unable to receive medications intranasally

Keywords: cluster seizures seizures clusters acute repetitive seizures
intelligent diagnosis and treatment model for insomnia disorder

Conditions: Insomnia

Summary: to establish a multicenter, multi-dimensional cohort on insomnia disorder and to develop an intelligent model for the diagnosis and treatment of insomnia disorder.

the study endeavors to establish a multicenter cohort comprising 16,000 individuals diagnosed with insomnia disorder, with a subsequent 2-year follow-up. objectives encompass elucidating the natural development of insomnia disorder within diverse populations, identifying associated factors, and evaluating the short-term and long-term impacts on physiological, psychological, and social functions in insomnia disorder. additionally, the research aims to devise early screening methodologies, precise assessments, and innovative disease classifications utilizing real-time assessment technology within the insomnia disorder cohort. furthermore, the investigation seeks to ascertain graded diagnoses, treatment modalities, and prognostic indicators based on advanced multi-dimensional real-time assessment technology applied to a substantial insomnia disorder cohort. finally, the study aims to refine remote interactive diagnostic and treatment modalities tailored to diverse age groups, culminating in developing a systematic graded diagnostic and treatment framework for insomnia disorder.

Eligibility criteria:
inclusion criteria: 1. a complaint of insomnia; 2. age between 18 and 75; 3. able to fill out the scale on their own; 4. agree to sign the informed consent to participate in the study and cooperate in completing the follow-up visit. exclusion criteria: 1.a current or history of comorbid axis i psychiatric disorders.

Keywords: insomnia intelligence model prediction differential diagnosis and treatment system