Kornimate/medical-research-clean huggingface dataset:
a study to test long-term treatment with spesolimab in people with palmoplantar pustulosis (ppp) who took part in previous studies with spesolimab

Conditions: Palmoplantar Pustulosis

Summary: this study is open to people with palmoplantar pustulosis who took part in previous clinical studies of a medicine called spesolimab. participants who benefited from spesolimab treatment in the previous studies can join this study. the purpose of this study is to find out how safe spesolimab is and whether it helps people with palmoplantar pustulosis in the long-term. participants are in this study for up to 5 years. during this time they visit the study site every month to get spesolimab injections under the skin. at study visits, doctors check the severity of participants' palmoplantar pustulosis and collect information on any health problems of the participants.


Eligibility criteria:
inclusion criteria: * signed and dated written informed consent for the current trial 1368-0024, in accordance with ich-gcp and local legislation prior to admission to the current trial * male or female patients who have completed the treatment period in one of the parent trials without premature discontinuation * patients who have obtained an individual health benefit, per investigator judgement (e.g. ppp pga of 0 (clear) or 1 (almost clear) or other clinical improvement), from treatment in the parent trial * women of childbearing potential must be ready and able to use highly effective methods of birth control per ich m3 (r2) that result in a low failure rate of less than 1% per year when used consistently and correctly exclusion criteria: * women who are pregnant, nursing, or who plan to become pregnant while in the trial * patients who experienced study treatment-limiting adverse events during the parent trial * severe, progressive, or uncontrolled condition such as renal, hepatic, haematological, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease, or signs and symptoms thereof * patients with congestive heart disease, as assessed by the investigator * patient with a transplanted organ (with exception of a corneal transplant \> 12 weeks prior to screening in parent trial) or who have ever received stem cell therapy (e.g., prochymal) * known history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease (e.g. splenomegaly) * any documented active or suspected malignancy or history of malignancy at screening, except appropriately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix * patients who have developed active or severe infective disease and opportunistic infections/infective diseases * further exclusion criteria apply
bioequivalence study in healthy subjects

Conditions: Hypertension

Summary: this study is designed as a phase-i, 2-period, cross-over, randomised, open-label, single centre study to determine bioequivalence of a single 32 mg dose of the proposed commercial oral suspension of candesartan cilexetil (1 mg/ml) and a single 32 mg dose of the candesartan cilexetil oral suspension (1.6 mg/ml) used in the paediatric program.


Eligibility criteria:
inclusion criteria: * provision of informed consent prior to any study specific procedures * body mass index (bmi) 19-27 kg/m2 calculated from height and weight at the screening visit * clinically normal physical findings including ecg and safety laboratory values at the screening visit and on day -1 of each treatment period, including negative results for drugs-of-abuse, alcohol, hepatitis b, hepatitis c and hiv. exclusion criteria: * history of significant mental, cardiac, renal, hepatic or significant gastrointestinal disease (that may affect the rate and extent of absorption of the ip), as judged by the investigator * any condition which could modify the absorption of the ips * previous randomisation of treatment in the present study * history or symptoms and signs of ongoing severe allergic disease/hypersensitivity

Keywords: candesartan bioequivalence
safety and effectiveness of repetitive transcranial magnetic stimulation in the treatment of tinnitus

Conditions: Tinnitus

Summary: tinnitus, i.e., the perception of sounds or noise in the absence of auditory stimuli, is a frequent and often severely disabling symptom of different disorders of the auditory system. there are currently no causal treatments. using repetitive transcranial magnetic stimulation (rtms), we have previously demonstrated that the temporoparietal cortex is critically involved in tinnitus perception and that tinnitus can be reduced by rtms applied to these cortical regions. therefore, it is reasonable to test rtms as a potential new treatment strategy against tinnitus. at this stage, small pilot studies indicate some effect on tinnitus impairment but the reduction is predominantly reported to be transient, with high interindividual variability, and questionable clinical relevance. moreover, the optimal stimulation area is unclear. here, we use theta burst stimulation (tbs), a new rtms paradigm for the prolonged modulation of cortical activity. the aim of this study is to test safety and effectivity of 4 weeks of daily bilateral tbs to two cortical areas on chronic tinnitus compared to sham-stimulation.


Eligibility criteria:
inclusion criteria: * subjective tinnitus \> 6 mo , \< 5 ys exclusion criteria: * objective tinnitus * seizures * brain trauma * brain surgery * pacemaker * intake of: benzodiazepines, antiepileptics, neuroleptics * suicidality

Keywords: tinnitus transcranial magnetic stimulation treatment cortex
basketball intervention program in children

Conditions: Basketball

Summary: the current project is a longitudinal, clinical study focused on evaluating the effects of a structured physical activity intervention in healthy prepubertal boys. the study will be conducted with the collaboration of the pediatrics department and the nutrition and metabolism area of the reina sofía university hospital in córdoba; the child metabolism and nutrigenomics. metabolic syndrome research groups at the maimónides institute for biomedical research (imibic); and the departments of biochemistry at both the university of córdoba and the university of granada. a total of 20 male participants, aged 9 to 12 years, will be selected. inclusion criteria include being healthy, in tanner stage i of pubertal development, and having anthropometric and cardiovascular parameters (weight, height, bmi, heart rate, systolic and diastolic blood pressure) within the 50th percentile ±1 standard deviation. children outside this range, or with signs of pubertal development, will be excluded. the intervention consists of a 3-year physical activity program structured into two annual phases: a 6-week preseason beginning each september, followed by a 32-week season coinciding with the academic year. during the preseason, participants will undergo five weekly 2-hour training sessions. the season will include three 2-hour after-school training sessions per week, and one weekend match. training sessions will be divided into two parts: individual skill development at moderate to high intensity (60-85% hr) and gameplay focusing on tactics and strategy. all sessions will be supervised by highly qualified coaches. physical fitness will be assessed through the eurofit test battery, including the course navette, sit and reach, 30-second sit-ups, and standing long jump tests. physical activity levels will be monitored using accelerometers, and data on weekly activity frequency, intensity, sedentary behavior, and leisure time will be collected. a comprehensive physical examination will include assessment of pubertal development, anthropometry, heart rate, and blood pressure. body composition will be measured using tanita bc-418 bioimpedance equipment, and will include height, weight, lean and fat mass, and body water percentage. additionally, biochemical markers of general health, inflammation (via lincoplex assays and luminex xmap technology), and oxidative stress will be analyzed.


Eligibility criteria:
inclusion criteria: * healthy male children * weight, height, bmi, heart rate, systolic and diastolic blood pressure within the 50th percentile ±1 sd * tanner stage i of pubertal development exclusion criteria: * boys younger than 9 or older than 12 years * anthropometric or physiological values above the 75th or below the 25th percentile

Keywords: basketball inflammation sports health childhood diet
a subjective observational study of patients using medicated footbath/footwash treatment in podiatry care

Conditions: Toenail Fungal Infection; Cellulitis; Pitted Keratolysis; Diabetic Foot Ulcer; Abscess

Summary: the purpose of this study is to evaluate the level of relief perceived by patients using medicated footbath/footwash with or without an oral medication for the treatment of podiatry issues.

footwash/footbath for treatment of; toenail fungus ingrown toenails cellulitis athletes' foot pitted keratolysis diabetic ulcers open infected sores abscesses joint infections wound care

Eligibility criteria:
inclusion criteria: participants must be diagnosed with an icd10 code indicative of toenail fungus, ingrown toenail, cellulitis, athletes foot, pitted keratolysis, diabetic ulcers, open infected sores, abscesses, and joint infections * participants must be starting a new regimen of a medicated footwash/foothbath * participants must be expecting to receive therapy for at least 12 weeks * participants must be between 18 and 64 years of age * participants must be able to provide sound verbal informed consent exclusion criteria: - participants must not be a beneficiary of government funded healthcare program (i.e. medicare, medicaid, etc.) • participants must not have a diagnosis of cancer within the past 5 years
pain in cancer survivors

Conditions: Breast Cancer; Colorectal Cancer; Prostate Cancer; Head and Neck Cancer; Lung Cancer

Summary: the purpose of this study is to find out about the pain and quality of life of individuals who are adult cancer survivors. by quality of life, we mean how you are feeling about different aspects of your life, including your physical health, your emotional health, and your ability to carry out daily activities. we are interested in people's opinions about their quality of life, as well as the factors that affect their quality of life. in addition, learning about pain will help us to develop new services for adult cancer survivors.

the main objective of the proposed study is to identify the prevalence of persistent pain in a sample of adult cancer survivors. currently, there is a lack of comprehensive information about pain in the cancer survivor population. although prior studies have assessed pain syndromes in breast and lung cancer survivors (e.g., post-mastectomy and post-thoracotomy pain), there is a lack of information about the prevalence and characteristics of post-treatment pain in other subpopulations of survivors. to address this knowledge gap, a random sample of cancer survivors who are from 1 to 10 years post-treatment completion and who were treated at memorial sloan-kettering cancer center will complete a telephone-administered pain interview and assessment battery focusing on pain, quality of life, and psychological distress. our initial recruitment and evaluation will begin in 50 breast cancer survivors and then will expand 50 survivors in each of the other services colorectal, genitourinary, head and neck, and thoracic in allotments of 50 participants each. we estimate that the completion time for the interview and assessment battery will range from 45 to 60 minutes. this telephone-based survey will identify vulnerable subgroups of patients with persistent pain and provide a knowledge base for future research on the prevalence and risk factors for post-treatment pain in the cancer survivor population.

Eligibility criteria:
inclusion criteria: * cancer treatment at mskcc * are from 1 to 10 years post-treatment completion at the time of study recruitment * no evidence of disease (ned) at the time of assessment; * over 18 years of age * can be reached by telephone * able to provide informed consent * able to speak and read english * cancer survivors who received adjuvant therapies outside mskcc will be asked to self-report the type and duration of cancer treatments received. exclusion criteria: * undergoing active cancer treatment (ongoing tamoxifen use, hormone replacement therapy or use of biologics are permitted) * evidence of encephalopathy, psychotic illness or cognitive impairment severe enough to preclude giving informed consent to the study staff, or completing the survey instruments of the study.

Keywords: breast cancer colorectal cancer prostate cancer head and neck cancer lung cancer cancer survivors 07-068 quality of life pain in cancer survivors
an investigational scan (hpmri) for monitoring treatment response in patients with thyroid cancer and other malignancies of the head and neck undergoing radiation therapy and/or systemic therapy

Conditions: Thyroid Gland Carcinoma

Summary: this trial investigates whether hyperpolarized magnetic resonance imaging (hpmri) can predict treatment response in patients with thyroid cancer and other malignancies of the head and neck undergoing radiation therapy and/or receiving systemic therapy before surgery. an hpmri is like a standard mri but involves the use of an imaging contrast agent called hyperpolarized 13-c-pyruvate. diagnostic procedures, such as hpmri, may predict a patient's response to treatment and may help plan the best treatment.

primary objective: i. to obtain pilot metabolic imaging data from hyperpolarized magnetic resonance imaging (hpmri) methods in patients with thyroid tumors or other malignancies of the head and neck receiving radiation therapy (xrt) and/or systemic therapy (e.g., target therapy, checkpoint inhibitors). secondary objective: i. to assess early metabolic changes in response to nonsurgical therapy, including standard-of-care fractionated xrt and/or systemic therapy. outline: participants are assigned to 1 of 2 arms. arm i: healthy volunteers undergo mri over 30 minutes. arm ii: patients with thyroid cancer and other malignancies of the head and neck undergo hpmri over 30 minutes at baseline, and at 1 week after the initiation of treatment. during the scan, patients also receive hyperpolarized 13-c-pyruvate intravenously (iv) over 30 seconds and may receive a standard mri contrast agent at the discretion of the treating physician. after completion of study intervention, thyroid cancer and other malignancies of the head and neck patients are followed up at 1 day.

Eligibility criteria:
inclusion criteria: * be willing and able to provide informed consent * be informed of the investigational nature of this study * be diagnosed with thyroid cancer and other malignancies of the head and neck with intent for treatment exclusion criteria: * have a history of severe claustrophobia * have electrically, magnetically or mechanically activated implants that would preclude magnetic resonance imaging (mri) * have a history of cardiac arrhythmia * have an allergy to gadavist intravenous contrast * estimated glomerular filtration rate (egfr) \< 30 * if female, be pregnant or breast feeding at time of consent
ivermectin versus albendazole for chronic strongyloidiasis

Conditions: Chronic Strongyloidiasis

Summary: a prospective controlled trial to compare the efficacy and safety of 7-day albendazole, single dose ivermectin, and 2-single dose ivermectin in 72 patients with chronic strongyloidiasis will be conducted at siriraj hospital, bangkok, thailand.


Eligibility criteria:
inclusion criteria: * patients with positive strongyloides larva in the stool exclusion criteria: * pregnancy * lactating women * known allergy to any study drug

Keywords: strongyloidiasis, ivermectin, albendazole
a study of minirin melt in patients with nocturia

Conditions: Nocturia

Summary: this is a confirmation of safety profile for minirin melt in clinical practice.


Eligibility criteria:
inclusion criteria: * nocturia exclusion criteria: * habitual or psychogenic polydipsia * known or suspected cardiac insufficiency and other conditions requiring treatment with diuretics * moderate and severe renal insufficiency * know hyponatremia * syndrome of inappropriate adh secretion
carbon ion radiotherapy for the treatment of chinese hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: the aim of this research project is to assess the feasibility and safety of carbon-ion radiotherapy for the treatment of localized chinese hepatocellular carcinoma

the purpose of this study is to determine the maximal tolerated dose (mtd) of carbon ion radiotherapy (cirt) in the treatment of localized chinese hepatocellular carcinoma with respective to toxicity and tumor control. participants will be treated with cirt with escalating dose regimens based on the tumor location to evaluate the maximal tolerated dose (mtd) in terms of acute and subacute toxicity observed during and within 3 months after the completion of cirt. primary endpoint is toxicity, second endpoint is progression-free survival, overall survival and tumor response.

Eligibility criteria:
inclusion criteria: 1. histologically confirmed hepatocellular carcinoma (hcc) or clinical diagnosis of hcc according to american association for the study of liver diseases （aasld）-guidelines or clinical diagnosis criteria based on alpha fetoprotein （afp), and radiological images proposed by liver cancer society, chinese anti-cancer association; 2. no clinically distant metastasis; 3. child push score a,technically unresectable, or medically inoperable; maximal tumor size is less than 12 cm; 4. age ≥ 18 and \<80 years of age; 5. karnofsky performance score ≥ 70; 6. no previous invasive cancer (within 5 years before the hcc diagnosis)except for skin non-melanoma cancer or non muscle invasive bladder cancer; ability to understand character and individual consequences of the clinical trial; 7. willing to sign the written informed consent; informed consent must be signed before the enrollment in the trial; exclusion criteria: 1. distant metastasis (m1); 2. maximal tumor size is more than 12 cm; 3. tumor invading adjacent gastrointestine (t4); 4. child push score b or c; 5. previous hepatic radiotherapy; 6. severe systemic disorders; 7. previous malignancy (within 5 years) except for skin non-melanoma cancer or 3-year disease free interval from previous malignancy like in situ cervix cancer or non muscle invasive bladder cancer; 8. non conformity of the radiotherapy dose distribution when compared to the dose constraints; 9. psychiatric disorders or any other condition that can make unreliable the informed consent;

Keywords: hepatocellular carcinoma carbon-ion radiotherapy toxicity efficacy
a study of tirzepatide (ly3298176) in participants with type 2 diabetes

Conditions: Type 2 Diabetes

Summary: the purpose of this study is to determine the efficacy of tirzepatide in participants with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * have type 2 diabetes (t2dm) for ≥6 months according to the criteria for diagnosing type 2 diabetes mellitus (american diabetes association 2017). * have hba1c of 7.0% to 10.5%, inclusive, as assessed by the central laboratory. * if on metformin, have been treated with stable doses of metformin for at least 3 months. * have a body mass index (bmi) between 23 and 45 (inclusive) kilograms per square meter. exclusion criteria: * have type 1 diabetes (t1d). * have used any glucose-lowering medication other than metformin within 3 months prior to study entry or during screening/lead-in period or have used any glucagon-like peptide-1 receptor agonists (glp-1 ras) at any time in the past 12 months. * have had any of the following cardiovascular conditions: acute myocardial infarction (mi), new york heart association class iii or class iv heart failure, or cerebrovascular accident (stroke). * have acute or chronic hepatitis, signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease (nafld), or alanine aminotransferase (alt) level \>2.5 times the upper limit of the reference range, as determined by the central laboratory at study entry; participants with nafld are eligible for participation in this trial. * have had chronic or acute pancreatitis any time prior to study entry. * have an estimated glomerular filtration rate (egfr) \<45 milliliters/minute/1.73 square meter, calculated by the chronic kidney disease-epidemiology (ckd-epi) equation. * have serum calcitonin ≥20 picograms per milliliter, as determined by the central laboratory at study entry. * have any condition that is a contraindication for use of the glp-1 ra class (per country-specific labels) at study entry or develop such condition between study entry and randomization.
an assessment of the zephyr biopatch and its ability to monitor patient position

Conditions: Patient Positioning; Monitoring, Physiologic; Pressure Ulcer

Summary: the primary objective of the study is to examine the effectiveness of the zephyr biopatch in measuring position changes of a non-patient subject in a lab setting and to examine the effectiveness of the zephyr biopatch in measuring position changes of hospitalized patients.


Eligibility criteria:
inclusion criteria for laboratory subject: 1. signed and dated informed consent by subject 2. male or female of any race 3. at least 18 years of age 4. willingness to have study device attached during study participation 5. willingness to participate in all aspects of the study exclusion criteria for laboratory subject: 1. implanted pacemaker or defibrillator 2. allergy or sensitivity to ecg leads or similar types of adhesive 3. history of hospital admission or a surgical procedure in the 60 days prior to study enrollment 4. bmi \> 30.0 inclusion criteria for hospital subjects: 1. signed and dated informed consent by subject 2. male or female of any race 3. at least 18 years of age 4. expected hospitalized admission on the general care floor for at least three days 5. at risk for hospital-acquired pressure ulcers as defined by score on the braden scale of \< 18 6. willingness to have study devices attached during study participation 7. willingness to participate in all aspects of the study exclusion criteria for hospital subjects: 1. implanted pacemaker or defibrillator 2. allergy or sensitivity to ecg leads or similar types of adhesive 3. subject will be sleeping in a chair or spending the majority of time in a chair 4. bmi \> 39.9
clinical trial to evaluate ultrasonic surgical device in chronic pressure ulcer

Conditions: Pressure Ulcer; Wound; Necrosis

Summary: study objective the purpose of this trial is to evaluate the efficacy and safety of the investigational device, ulsd-12d, as compared to the comparator, sonoca-180, in chronic wound.

* study design multi-center, randomized clinical trial * study population adults with chronic wound * investigational device treatment procedure before treatment: the subject's eligibility (inclusion/exclusion criteria) will be assessed,and apply the study device or comparator on their wound in a randomized manner. post-treatment: all subjects will take pictures of the wound area and measured the number of microorganism and wound size.

Eligibility criteria:
inclusion criteria: * over 20 years of age * subject who has untreated wounds * subject who has wound size over 3cm x 3cm * subject who has wound over stage 2 exclusion criteria: * cellulitis

Keywords: pressure ulcer chronic wound tissue necrosis slough ultra sound