Kornimate/medical-research-clean huggingface dataset:
enhancing exercise participation in overweight adults

Conditions: Weight Loss

Summary: the purpose of this study is to examine whether behavioral strategies implemented during the adoption versus the maintenance periods of weight loss to enhance exercise participation in overweight adults are more effective than a standard behavioral intervention.


Eligibility criteria:
inclusion criteria: 1. female or male 2. 18-55 years of age 3. bmi = 25-39.9 kg/m2 4. ability to provide informed consent. 5. ability to provide consent from their personal physician to participate in this study. exclusion criteria: 1. reporting regular exercise participation of at least 20 minutes per day on at least 3 days per week during the previous six months. (this study is designed to recruit relatively sedentary adults.) 2. diabetes, hypothyroidism, or other medical conditions which would affect energy metabolism. 3. women who are currently pregnant, pregnant within the previous six months, or planning on becoming pregnant within the next 18 months. (pregnancy during initial screening will be based on self-report and will be included on the detailed medical history that is completed by subjects) 4. non-medicated resting systolic blood pressure \>160 mmhg or non-medicated resting diastolic blood pressure \>100 mmhg, or taking medication that would affect blood pressure. 5. taking medication that would affect resting heart rate or the heart rate response during exercise (e.g., beta blockade). 6. arrhythmia on resting or exercise electrocardiogram that would indicate that vigorous exercise was contraindicated. 7. history of myocardial infarction or valvular disease. 8. weight loss of \>5% of body weight within the previous 12 months. 9. history of orthopedic complications that would prevent optimal participation in the exercise component (e.g., heel spurs, severe arthritis).
onabotulinumtoxina treatment in adult patients with upper limb spasticity

Conditions: Muscle Spasticity; Stroke

Summary: this is a safety and efficacy study of onabotulinumtoxina in poststroke patients with upper limb spasticity.


Eligibility criteria:
inclusion criteria: * upper limb spasticity in the elbow and shoulder due to stroke, with the most recent stroke at least 3 months ago exclusion criteria: * spasticity in the non-study upper limb that requires treatment * presence of fixed contractures in of the study muscles in elbow or shoulder * profound atrophy of muscles to be injected * previous surgical intervention, nerve block, or muscle block for the treatment of spasticity in the study limb in the last 12 months * injection of corticosteroids or anesthetics, use of casting or dynamic splinting or constraint-induced movement therapy (cimt) for the study limb within 3 months * ultrasound therapy, electrical stimulation, or acupuncture in the study limb within 1 month * condition other than stroke contributing to upper limb spasticity * diagnosis of myasthenia gravis, eaton-lambert syndrome, and/or amyotrophic lateral sclerosis
a study of qls32015 in patients with recurrent or refractory multiple myeloma

Conditions: Relapsed or Refractory Multiple Myeloma

Summary: the purpose of this study is to characterize the safety of qls32015 injection and to determine the recommended phase 2 dose (rp2d) and to further evaluate the efficacy and safety of qls32015 injection in participants with relapsed or refractory multiple myeloma at the recommended phase 2 dose.

multiple myeloma (mm) is a malignant disease with abnormal proliferation of clonal plasma cell, which is often accompanied by multiple osteolytic damage, hypercalcemia, anemia, and kidney damage. qls32015 is a humanized immunoglobulin gamma-1 (igg1) type bispecific antibody targeting g protein-coupled receptor family c group 5-member d (gprc5d) and cluster of differentiation 3 (cd3). the study consists 3 periods: screening phase, treatment phase and a post-treatment follow-up phase. the study will evaluate safety, tolerability, pharmacokinetics and preliminary antitumor activity of qls32015 administered to participants with relapsed or refractory multiple myeloma. total duration of study is up to 2 years.

Eligibility criteria:
inclusion criteria: * age ≥18 years old, regardless of gender. * subjects should be willing and able to comply with the study schedule and protocols. * documented initial diagnosis of multiple myeloma according to international myeloma working group (imwg) diagnostic criteria. * must have measurable disease as defined by the following: serum m-protein greater than or equal to 1 g/dl; or urine m-protein greater than or equal to 200 mg/24 hours; or serum free light chain (flc) assay; involved flc level greater than or equal to 10 mg/dl provided the serum flc ratio is abnormal. exclusion criteria: * known hypersensitivity to any of the ingredients of this product. * diagnosis of active plasma cell leukemia or systemic light chain amyloidosis. * has any active severe mental illness, medical illness, or other symptoms/conditions that may affect treatment, compliance, or the ability to provide informed consent, as determined by the investigator.
enstilar in combination with enbrel or humira for plaque psoriasis

Conditions: Psoriasis

Summary: 4 weeks of adjunctive therapy of enstilar® qd followed by 12 weeks qod to patients with 2-10% bsa who are receiving etanercept or adalimumab for at least 24 weeks

30 subjects treated with etanercept or adalimumab for at least 24 weeks with a body surface area 2-10% and physician global assessment greater than or equal to 2 will receive enstilar® once daily for 4 weeks followed by qod for 12 weeks.

Eligibility criteria:
inclusion criteria: * male or female adult ≥ 18 years of age; * diagnosis of chronic plaque-type * patient with 2-10% bsa * physician global assessment of 2 or greater * patient has been treated with etanercept or adalimumab for a minimum of 24 weeks exclusion criteria: * ˂2 or \>10% bsa * pga \<2 * patient not receiving etanercept or adalimumab, or receiving etanercept or adalimumab \<24weeks
comparison between whole body dwi and fdg pet/ct in patients with simptomatic multiple myeloma

Conditions: Multiple Myeloma

Summary: the primary objective is to evaluate the concordance of fdg pet/ct and total body dwi mri sequences performed during staging and at the completion of therapy. specifically, we will assess the positivity rates, both patient-based and lesion-based (total and by district), of the two methods during staging and at the completion of therapy. an interim analysis will be conducted comparing the two methods, followed by a final prognostic analysis.


Eligibility criteria:
inclusion criteria: * • patients with symptomatic myeloma in the staging phase or with suspected symptomatic myeloma in the diagnostic phase * patients who have signed the informed consent form exclusion criteria: * patients simultaneously affected by other neoplastic diseases or with a history of other neoplasms in the previous 5 years * age \< 18 years * women who are breastfeeding or pregnant * patients with metal implants or devices that constitute an absolute contraindication for mri * patients with severe claustrophobia * patients with bone pain that prevents prolonged maintenance of the supine position

Keywords: multiple myeloma, staging, therapy assessment, dwi, fdg pet ct
subcutaneous alxn1830 in adult participants with warm autoimmune hemolytic anemia

Conditions: Warm Autoimmune Hemolytic Anemia

Summary: this is a phase 2, multiple ascending, dose-finding, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, health-related quality of life, tolerability, pharmacokinetic, pharmacodynamic, and immunogenicity, of up to 3 dose regimens of alxn1830 administered subcutaneous(ly) (sc) in the treatment of waiha. this study will include 2 randomized, double-blind, placebo-controlled cohorts (cohorts 1 and 2) to evaluate an 8-week treatment regimen, and an optional third open-label cohort (cohort 3) to evaluate an alternative 12-week dosing regimen. participants may continue participation in this study at the participant's and investigator's discretion in an open-label extension (ole) period, consisting of monthly visits to observe participants for relapse, which will require going back on active treatment.


Eligibility criteria:
key inclusion criteria: * diagnosed with primary or secondary waiha at least 6 weeks prior to screening. * failed or have not tolerated at least one prior waiha treatment regimen, for example, corticosteroids, rituximab, azathioprine, cyclophosphamide, cyclosporine, mycophenolate mofetil, danazol, or vincristine. * hemoglobin \< 10 g/dl and ≥ 6 g/dl at screening. * positive direct antiglobulin test (coombs) (igg positive who are positive or negative for the presence of complement c3) at screening. * evidence of active hemolysis including any one of the below: * ldh \> upper limit of normal (uln) or * haptoglobin \< lower limit of normal or * indirect bilirubin \> uln * total igg \> 500 mg/dl at screening * platelet count ≥ 75 x 10\^9/liter (l) * absolute neutrophil count greater than 1.0 x 10\^9/l key exclusion criteria: * participants with evan's syndrome. * human immunodeficiency virus (hiv) infection (positive hiv 1 or hiv 2 antibody test). * positive hepatitis b surface antigen or hepatitis c antibody test. * inability to travel to the clinic for specified visits during the primary treatment period or fulfill the logistical requirements of study intervention administration.

Keywords: warm autoimmune hemolytic anemia waiha immunoglobulin g-mediated autoimmune disorder pathogenesis anti-neonatal fc receptor alxn1830
acceptability and tolerance study of a thickener

Conditions: Dysphagia

Summary: this is a prospective, acceptability study to evaluate the gastrointestinal tolerance and compliance of a thickener for the management of reflux, gord and dysphagia

to evaluate the gastrointestinal tolerance and compliance of a thickener for 7 days for the submission to the advisory committee for borderline substances (acbs).

Eligibility criteria:
inclusion criteria: i. infants and children aged 6 months and over who require a thickener for reflux, gord, dysphagia ii. infants and children already on a thickener for the management of reflux, gord and dysphagia iii. parents to avoid introducing new weaning/ new foods (for the older infants) whilst on the thickener for 1 week when measuring gi tolerance and thickener intake iv. willingly given, written, informed consent from patient or parent/guardian exclusion criteria: i. inability to comply with the study protocol, in the opinion of the investigator. ii. contraindications to any feed ingredients (see nutritional table and ingredients list) iii. allergy to milk (thickener is made in a factory that handles milk) iv. children under the age of 6 months of age v. emergencies vi. participation in another interventional study -
use of hemopatch as a sealant at the pancreaticojejunostomy after pancreatoduodenectomy

Conditions: Pancreatic Fistula

Summary: the objective of this study is to determine the effect of the sealant patch hemopatch, compared to current practice without any sealant, on the decrease of the postoperative pancreatic fistula on patients undergoing pancreatoduodenectomy for benign or malignant tumors or other benign process.

pancreaticoduodenectomy (pd) is the most common surgical procedure to treat pancreatic tumors in the head of the pancreas and periampullary region, as well as benign processes such as chronic pancreatitis. recent advances in surgical techniques and perioperative treatments have reduced perioperative mortality below 10% in high volume centers. however, pd is associated with considerable morbidity (40-58.5%) like postoperative pancreatic fistula, delayed gastric emptying, biliary fistula, postoperative hemorrhage, and pulmonary complications. several surgical techniques and perioperative care have been described to prevent or reduce the incidence of pancreatic fistula after pd, including reconstruction of the digestive tract with pancreaticogastrostomy, duc-to-mucosa reconstruction or pancreaticojejunostomy by intussusception, use of somatostatin and prophylactic analogues, the use of stents in the main pancreatic duct, and use of different sealants. although perioperative morbidity and mortality associated with pd have improved significantly over the years, even in high-volume centers, the incidence of postoperative fistula remains at 9.9-28.5%. therefore, the ideal pancreatic reconstruction technique that prevents fistula is not yet available. the use of sealants has been one of the approaches taken to try to reduce the rate of fistulas. some uncontrolled or non-randomized studies have shown that the use of fibrin glue-based adhesives in combinations with felting patches can lead to a b / c grade fistula rate of 0-10%. only 2 randomized clinical trials have been performed with fibrin glue, with opposite results in terms of significant reduction of pancreatic fistula. hemopatch is a patch consisting of a soft, thin and flexible pad of collagen derived from the bovine dermis, coated with nhs-peg (pentaerythritol polyethylene glycol ether tetra-succinimidyl glutarate). it is intended to be a surgical sealant for procedures in which control of leakage by conventional surgical techniques is ineffective or impractical, making it a plausible option to use during pd in order to decrease postoperative pancreatic fistula.

Eligibility criteria:
inclusion criteria: * patients scheduled for pancreatoduodenectomy by open approach, depending on the diagnosis/nature of the tumor. * asa score \< 4. * male and female patients ≥ 18 and ≤ 80 years of age. * with the consent form signed. exclusion criteria: * patients scheduled for pancreatoduodenectomy by open approach, depending on the diagnosis/nature of the tumor. * asa score \< 4. * male and female patients ≥ 18 and ≤ 80 years of age. * with the consent form signed.

Keywords: pancreatoduodenectomy postoperative pancreatic fistula sealant hemopatch
fast (fluid accumulation status trial)

Conditions: Congestive Heart Failure; Cardiomyopathy; Dyspnea; Pulmonary Edema; Heart Diseases

Summary: heart failure is a progressive disease that decreases the pumping action of the heart. this may cause a backup of fluid in the heart and may result in heart beat changes. using very low electrical pulses that travel across the inside of the chest cavity, thoracic fluid status monitoring (optivol™) can measure the level of resistance to the electrical pulses, which indicates the level of fluid in the chest. the purpose of this study is to collect information related to fluid build up in the chest of subjects with heart failure.


Eligibility criteria:
inclusion criteria: * subjects with one of the following implantable cardioverter defibrillators (icds): insync marquis™, insync ii marquis™, marquis® dr, or insync iii marquis™. * subjects with an icd placed in the upper part of the left or right side of their chest. * subjects with a lead (flexible wire that sends electrical signals from the icd directly to the heart tissue) that is inserted through a vein and placed in the right ventricle (rv) of the heart (a transvenous rv lead). * subjects who underwent the icd implant procedure, or any readjusting of the icd, 30 days or more prior to enrolling in the study. exclusion criteria: * subjects who are already enrolled in another clinical study. * subjects who have received a heart transplant. * subjects who are unable or unwilling to follow the study schedule of visits.

Keywords: cardiomyopathy ventricular ejection fraction congestive heart failure impedance
a clinical study on tils for the treatment of advanced solid tumors

Conditions: Solid Tumor

Summary: this study is an open exploratory clinical study to evaluate the safety, tolerance, immune response, and initial efficacy of autologous tumor infiltrating lymphocyte lm103 injection in advanced solid tumor patients . the research treatment includes fludarabine and cyclophosphamide, autologous tumor infiltrating lymphocytes (tils) infusion, and interleukin-2 therapy.


Eligibility criteria:
inclusion criteria: 1. the expected survival time is not less than 3 months. 2. clinical performance status of eastern cooperative oncology group (ecog) 0-1. 3. patients with advanced solid tumors confirmed by histology or cytology: advanced melanoma, cervical cancer/ovarian cancer, head and neck squamous cell cancer, non-small cell lung cancer, esophageal cancer and other solid tumors that have failed standard treatment regimens, cannot tolerate standard treatment, refuse or do not have standard treatment regimens available. 4. the patient has lesions that can be used for surgical resection (\>1.5 cm3) or biopsy puncture (no less than 6 lesions) for tils collection. 5. at least one measurable lesion as the target lesion after collecting tumor tissue from the patient (recist v1.1 criteria). 6. laboratory tests results during the screening period indicate that the subjects have sufficient organ function. exclusion criteria: 1. have a medical history of other malignant tumors other than the disease under study in the past 5 years, except for malignant tumors that can be expected to recover after treatment (including but not limited to thyroid cancer, cervical carcinoma in situ, basal or squamous cell skin cancer or ductal carcinoma in situ of the breast treated by radical surgery). 2. lm103 received systematic sex therapy of antineoplastic drugs (including chemotherapy, small molecule targeted drug therapy, hormone replacement therapy, etc.), or local antineoplastic therapy (such as radiotherapy, palliative radiotherapy for bone metastases\>2 weeks before the start of the study and intracranial stereotactic radiotherapy or resection of a single brain metastasis\>3 weeks before the start of the study were acceptable) within 4 weeks before lm103 infusion; or received clinical investigational drugs or equipment treatment. 3. adverse reactions caused by previous treatment have not recovered to ctcae (version 5.0) level 1 or below (excluding hair loss and neurotoxicity, which have been determined by the researchers to be irreparable and level 2 hypothyroidism for a long time). 4. previously received allogeneic hematopoietic stem cell transplantation or solid organ transplantation.
developing an utstein-style danish drowning registry: nationwide fatal and nonfatal drowning data since 2016

Conditions: Drowning; Drowning, Near; Drowning; Asphyxia; Drowning and Nonfatal Submersion; Drowning or Immersion of Unknown Intent; Drowning and Submersion, Undetermined Intent; Drowning and Submersion While in Bath-Tub; Drowning and Submersion While in Natural Water; Drowning and Submersion While in Swimming-Pool

Summary: this nationwide, registry-based study aims to link danish prehospital drowning data data with inhospital data to develop a utstein-style danish drowning registry. this study will report mortality and neurological outcomes 30 days after a drowning incident since 2016.

purpose the purpose of this study is to establish recommendations towards specific educational, preventative, rescue, or treatment strategies to reduce the number of fatal and non-fatal drowning incidents in denmark (e.g., campaigns targeting high-risk groups, or fencing, allocating rescue equipment, or establishing lifeguard stations in high-risk areas). objectives the primary objective is to estimate 30-day mortality of drowning incidents in denmark treated by the emergency medical services from 2016. the secondary objective is to explore risk factors associated with 30-day mortality. study design a nationwide registry-based study linking data from the danish prehospital drowning data with data from the inhospital electronic medical records. from 2016 and follow-up on mortality 30 days after the drowning incident. neurological outcomes will be assessed by trained observers through the inhospital electronic medical records.

Eligibility criteria:
inclusion criteria: * drowning * being registered in the danish prehospital drowning data with a valid civil registration number to allow for linkage with the inhospital electronic medical records exclusion criteria: * obvious signs of irreversible death (decapitation, decomposition, post-mortem lividity, post-mortem rigidity). * declared dead on scene. * a valid do-not-attempt-resuscitation order or other code status orders limiting life-sustaining therapies. * an invalid civil registration number.

Keywords: danish drowning formula drowning danish prehospital drowning data registry database emergency medical service utstein register epidemiology
clinical phenotypes of copd patients between in plateau and plain

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: we aimed to collect clinical and radiological data of patients with stable copd in plateau and plain, and compare the clinical phenotypic characteristics and imaging features of copd patients in these two areas.

the purpose of this study was to investigate the clinical phenotypic characteristics and imaging features of patients with stable chronic obstructive pulmonary disease (copd) in plateau and plain. we conducted a cross-sectional study, collecting clinical data of stable patients in plateau and plain, and comparing the clinical phenotypic characteristics and imaging features of copd patients in these two areas.

Eligibility criteria:
inclusion criteria: * meeting the diagnosis of copd according to global initiative for chronic obstructive lung disease (gold) guidelines and had definite airflow limitation with a post-bronchodilator forced expiratory volume in 1 second (fev1) / forced vital capacity (fvc)\<0.7. exclusion criteria: * age \<40 years; * subjects with airway diseases other than copd; * acute exacerbation of copd in the past 3 months; * active tuberculosis; * cardiovascular or cerebrovascular events in the past 3 months; * cognitive dysfunction such as vascular dementia or alzheimer's disease; * refusal to participate in this study.