Kornimate/medical-research-clean huggingface dataset:
a study of cebranopadol for the treatment of acute pain after bunionectomy

Conditions: Acute Pain

Summary: the purpose of this study is to evaluate the efficacy and safety of cebranopadol for acute pain after a bunionectomy.

this study is a phase 3, multicenter, randomized, double-blind, placebo- and active-controlled parallel-group study to evaluate the efficacy and safety of cebranopadol in the treatment of postoperative pain following primary unilateral bunionectomy with first metatarsal osteotomy. the study will be conducted in 3 phases: screening, treatment, and follow-up.

Eligibility criteria:
key inclusion criteria before surgery: * scheduled to undergo primary unilateral bunionectomy with first metatarsal osteotomy and internal fixation with no collateral procedures, using anesthesiologic and surgical procedures planned. * must be able to adhere to the visit schedule, complete all study assessments and protocol requirements, including self-reported questionnaires. key exclusion criteria before surgery: * any clinically significant disease, medical condition, or laboratory finding that in the investigator's opinion may interfere with the study procedures or data integrity, or compromise the safety of the subject. * secondary (i.e., unrelated to bunion) current painful condition that could confound the interpretation of efficacy, safety, or tolerability data in the study, in the opinion of the investigator. * subjects who require any analgesic for secondary (i.e., unrelated to bunion) painful condition that might impact the subject's ability to properly assess their postoperative pain, or that may require treatment during the treatment phase. * history of allergy or hypersensitivity to any opioid analgesics, anesthetics, ibuprofen, or other nsaids. immediate postoperative exclusion criteria: * surgical, postsurgical, or anesthetic complication that could confound the interpretation of efficacy, safety, or tolerability data in the study. * deviation from the surgical, postsurgical, or anesthetic protocol that could confound the interpretation of efficacy, safety, or tolerability data in the study. * evidence of hemodynamic instability or respiratory insufficiency.

Keywords: bunionectomy
safety and efficacy clinical study of sns-595 in patients with platinum-resistant ovarian cancer

Conditions: Epithelial Ovarian Cancer

Summary: the purpose of this study is to evaluate the objective response rate, safety and identify potential biomarkers in platinum-resistant ovarian cancer patients treated with voreloxin injection given on a 28-day cycle.

other objectives of this study are to evaluate progression-free survival and measure ca-125 response rate.

Eligibility criteria:
inclusion criteria: * histologically or cytologically documented epithelial ovarian cancer, primary peritoneal carcinoma, or fallopian tube cancer * completed at least one platinum based therapy (pbt) regimen (carboplatin, cisplatin, or another organoplatinum compound). * evidence of platinum-resistant disease, relapse/progression within 6 months of the completion of pbt, or intolerant to pbt (inability to receive pbt due to hypersensitivity reactions to platinum) * patients with primary platinum-resistant disease are allowed to receive no more than one nonplatinum cytotoxic regimen and no more than one noncytotoxic regimen for the management of recurrent or persistent disease after the development of primary platinum-resistance. * measurable disease per gog-recist criteria * gog performance status of 0 or 1 exclusion criteria: * radiotherapy, chemotherapy, and hormonal, cytokine, or targeted therapy, within 3 weeks (nitrosurea or mitomycin c within 6 weeks) prior to the anticipated first day of treatment. * monoclonal antibody therapy within 4 weeks prior to clinical study entry * unresolved or impending bowel obstruction * other active malignancies or other malignancies within the last 12 months except nonmelanoma skin cancer or cervical intraepithelial neoplasia * prior radiotherapy to more than 25% of the marrow space * requiring hemodialysis or peritoneal dialysis * myocardial infarction or cerebrovascular accident/transient ischemic attack within the 6 months prior to the anticipated first day of treatment * thromboembolic event (deep vein thrombosis \[dvt\] or pulmonary embolus \[pe\]) within 28 days prior to the anticipated first day of treatment * history of active cns metastases * any other medical, psychological, or social condition that would contraindicate the patient's participation in the clinical study due to safety or compliance with clinical study procedures. please note: there are additional inclusion/exclusion criteria for this study. please contact the study center for additional information and to determine if you meet all study criteria.

Keywords: second line treatment platinum resistant ovary ovaries cancer epithelial carcinomas tumor
learning implementation of guideline-based decision support system for hypertension treatment: testing alternative antihypertensive regimens using ace-inhibitors, calcium channel blockers and diuretics (light-acd)

Conditions: Hypertension

Summary: this trial aims to compare the efficacy of several guideline-based hypertensive medication regimens initiated with angiotensin converting enzyme inhibitor/angiotensin receptor blocker \[a\], calcium channel blocker \[c\] and diuretic \[d\].

the light-acd trial is conducted based on the light trial and aims to compare the efficacy of several guideline-based hypertensive medication regimens initiated with a, c and d for bp control.

Eligibility criteria:
inclusion criteria: 1. age ≥18 years 2. local resident of the community/township who attend a phc center with dss treatment of hypertension 3. established diagnosis of essential hypertension, with sbp≥140mmhg and \<180mmhg 4. not currently taking any antihypertensive medication or taking only one antihypertensive medication which in not b exclusion criteria: 1. history of coronary heart disease (i.e., angina, mi, cabg, pci, \>50% stenosis of coronary artery, or positive stress test) 2. physician-diagnosed or self-reported ckd, egfr \<60 ml/min/1.73m2 (if serum creatinine available), or currently on dialysis 3. physician-diagnosed diabetes mellitus 4. physician-diagnosed heart failure 5. physician-diagnosed secondary hypertension 6. intolerance to any class of antihypertensive medications among a, c or d 7. other serious medical illness such as malignant cancer, hepatic dysfunction, et al. 8. currently at the acute phase of any diseases 9. subject is pregnant or breast feeding, or planning to become pregnant or breast feeding during study period 10. patients measured blood pressure at home and the average self-measured home blood pressure \<135/85mmhg
dietary fish oil intervention in polycystic ovary syndrome (pcos)

Conditions: Polycystic Ovary Syndrome; Lipid Metabolism Disorders

Summary: the primary objective in this proposed study is to determine the effect of dietary fish oil supplementation compared to standard care metformin treatment, and fish oil in combination with metformin on plasma lipids and apob-remnant lipoprotein metabolism in overweight-obese young women with pcos.

specific objectives; 1. to determine the effect of dietary fish oil supplementation, metformin, and fish oil in combination with metformin on fasting and non-fasting plasma tg, apob48 and apob100-lipoprotein concentrations. 2. to determine the physiological mechanisms associated with the effect of dietary fish oil supplementation and metformin on in vivo plasma lipid and apob-lipoprotein kinetics. we will quantitate the in vivo production and kinetics of plasma tg, apob48 and apob100-lipoproteins in plasma and isolated lipoprotein fractions, using established methods. 3. to explore the effects of dietary fish oil supplementation, metformin and fish oil in combination with metformin, on plasma insulin and testosterone, and the association with changes in plasma lipids and apob-lipoprotein metabolism.

Eligibility criteria:
inclusion criteria: * female * age at time of enrollment \> 18 to \<30 years * diagnosis of pcos: clinical and/or biochemical hyperandrogenemia and menstrual dysfunction and the exclusion of other disorders. * overweight-obese (bmi \>25 kg/m2) high-risk metabolically-resistant young women. * elevated fasting plasma tg (\>150 mg/dl) and apob48-remnant cholesterol lipoproteins (\>20 ug/ml). * impaired insulin sensitivity (glucose 100-125 mg/dl and/or insulin \>15 (um/ml); and * may be diagnosed with t2d (blood glucose \>126 mg/dl). exclusion criteria: * pregnancy * lactating women * recent illness that the investigator determines to pose a potential risk for the participant * concomitant medications that influence metabolism (e.g. statins) * excessive alcohol consumption, as determined by the investigator.

Keywords: polycystic ovary syndrome metabolic and cardiovascular diseases diabetes obesity
anc-501 in the treatment of adults with major depressive disorder

Conditions: Major Depressive Disorder

Summary: a phase 2 study of anc-501 in the treatment of adults with major depressive disorder

this is a single-arm, open-label phase 2 study to assess the safety, tolerability, pharmacokinetics (pk), and activity of anc-501 oral capsules as adjunctive treatment in subjects diagnosed with major depressive disorder (mdd)

Eligibility criteria:
inclusion criteria: * adult male or female between 18 and 65 years of age, inclusive. * diagnosis of current episode of major depressive disorder (mdd) at least 8 weeks prior to screening, confirmed by structured clinical interview for dsm-5 - clinical trials version (scid-5-ct). * have not responded to their current antidepressant therapy or to dose adjustment/treatment changes following a loss of response to their current antidepressant therapy. * receiving a stable dose of the same antidepressant (selective serotonin reuptake inhibitor \[ssri\] or serotonin and norepinephrine reuptake inhibitor \[snri\], bupropion or trazodone monotherapy) for the current episode for at least 6 weeks of continuous treatment, which can include some or all of the screening period, with 4 weeks on a stable dose prior to day 1 and has an inadequate response (\<50% improvement) using the mgh atrq. * madrs total score of ≥26 at screening and day 1 (prior to dosing). * 12-hour urine cortisol level \>22.7 nmol/l(greater than or equal to 8.3 mcg/l). exclusion criteria: * inadequate response to \>2 prior adts (not including current antidepressant) of at least 6 weeks duration each for the episode current at screening. * medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder. * administration of drugs to treat psychiatric or neurologic conditions that have not been taken at a stable dose for at least 4 weeks prior to day 1. * significant findings on ophthalmic examination including, best corrected visual acuity (bcva) worse than 20/30 or, in the opinion of the ophthalmologist or optometrist, any cataract that may become clinically significant and/or need surgical intervention during the course of the trial.
effects of simulated equestrian therapy on motor proficiency and gait parameters among down syndrome children

Conditions: Down Syndrome

Summary: according to the world health organization (who) and united nations children's fund (unicef), one billion people suffer from physical and mental disabilities, with 240 million children. whereas 26.4 million belong to asia, and approximately 5 million are from pakistan. the centre for disease control and prevention (cdc) reports developmental disorders as one of the leading causes of these disabilities. several conditions are classified under this domain, including autism spectrum disorder, attention-deficit hyperactivity disorder, down syndrome, and cerebral palsy. down syndrome (ds) has recently emerged as a prevailing condition in low-and middle-income countries, with an incidence of 1 in every 300 babies. ds is a genetic disorder due to the triplication of all or some parts of the 21st chromosome. various problems characterize this disability, including; compromised motor skills proficiency and altered gait parameters. these deficits have been addressed using numerous effective techniques, one of which is 'simulated equestrian therapy'. despite advances in rehabilitating ds patients, a scarcity of literature still surfaces regarding using these simulators and their effects. to our knowledge, no study in pakistan has been conducted to evaluate motor proficiency and gait parameters in the ds population using this intervention. therefore, the present study is aimed to assess the effects of simulated equestrian therapy on motor proficiency and gait parameters in ds children.

a total of 58 participants will be recruited for this study after obtaining informed voluntary assent from the guardians. simple random sampling using the envelop method will be used for the group allocation, to which the participants will be blind. each participant will be allocated randomly to the treatment group (n=29) that will receive simulated equestrian therapy and the control group (n=29) to receive neuromotor therapy. each participant will be assessed at baseline, after 6 and 12 weeks of intervention using bruinink's test of motor proficiency (bot-2) and 10 meter walk test (10mwt). each participant's blood pressure and heart rate will also be recorded before each session to ensure safety. the participants will be wearing protective gear (belt, helmet, knee and elbow pads) and portable telemetry during the entire session. the session duration in both groups will comprise 30-45 minutes on average, varying with the progression each week. each session will be provided three times/a week for 3 months.

Eligibility criteria:
inclusion criteria: * individuals with diagnosed ds are referred by a physician. * age 6-12 years. * ability to independently walk, gmfcs level-i. exclusion criteria: * diagnosed atlantoaxial instability. * diagnosed osteoarticular, pulmonary or cardiovascular disorders. * diagnosed severe behavioral or cognitive impairment. * severe visual impairment that cannot be corrected with glasses. * if equestrian therapy received in the last 1-year. * refusal of parents/guardians to participate in the study.
a study to measure the effects of using tradipitant on nausea and vomiting after glp-1r agonist use

Conditions: Obesity

Summary: the goal of this study is to measure the effects of using tradipitant after glp-1r agonist use on nausea and vomiting in healthy overweight, class i, or class ii obese volunteers. the study is placebo-controlled with two treatment arms.


Eligibility criteria:
inclusion criteria: * body mass index 25-40 kg/m\^2 inclusive * no serious medical problems or chronic diseases, specifically no type i or type ii diabetes exclusion criteria: * another disorder that contributes to gastrointestinal symptoms * history of intolerance and/or hypersensitivity to nk-1 receptor antagonists * history of intolerance and/or hypersensitivity to glp-1 receptor agonists * exposure to any investigational medication within the past 60 days

Keywords: glp-1r agonist semaglutide obesity nausea vomiting
single dose bioequivalence study comparing nifedipine/candesartan fdc (fixed dose combination) with loose combination of nifedipine gits (gastro-intestinal therapeutic system) plus candesartan and single components under fasting conditions

Conditions: Hypertension, Essential

Summary: randomized, open label, single dose, 4-way crossover study to investigate the bioequivalence of a new fixed dose combination tablet of nifedipine gits and candesartan with the corresponding loose combination and to compare it with the individual drugs


Eligibility criteria:
inclusion criteria: * healthy male subject * age: 18 to 45 years (inclusive) at the first screening / examination visit * ethnicity: caucasian * body mass index (bmi): \>/=18 and \</=29,9 kg/m² exclusion criteria: * systolic blood pressure below 120 or above 145 mmhg * diastolic blood pressure above 95 mmhg * heart rate below 45 or above 95 beats / min * clinically relevant findings in the physical examination * suspicion of drug or alcohol abuse * regular daily consumption of more than 1 l of xanthin-containing beverages * intake of foods or beverages containing grapefruit within 4 weeks before the pre-study examination

Keywords: bioequivalence nifedipine candesartan fdc
study of kite-363 or kite-753 in participants with relapsed and/or refractory b-cell lymphoma

Conditions: Relapsed and/or Refractory B-cell Lymphoma

Summary: the goal of this clinical study is to learn more about the safety and dosing of the study drugs, kite-363 and kite-753, in participants with relapsed and/or refractory b-cell lymphoma.

eligible study participants who have received ip administration with either kite-363 or kite-753 will transition to a separate long-term follow-up study (study kt-us-982-5968) to complete the remainder of the 15-year follow-up assessments.

Eligibility criteria:
key inclusion criteria: * relapsed and/or refractory b-cell lymphoma (r/r bcl). * at least 1 measurable lesion. * adequate organ and bone marrow (bm) function. key exclusion criteria: * history of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg, cervix, bladder, or breast) unless disease free and without anticancer therapy (with the exception of hormonal therapy in the case of breast cancer) for at least 3 years. * history of richter's transformation of chronic leukemic lymphoma, small lymphocytic lymphoma, or lymphoplasmacytic lymphoma. * history of allogeneic stem cell transplant (allo-sct). * auto-sct within 6 weeks before the planned kite-363 or kite-753 infusion. * presence of fungal, bacterial, viral, or other infection that is uncontrolled or requires intravenous (iv) antimicrobials for management. * known history of human immunodeficiency virus (hiv) infection, hepatitis b virus (hbv) hepatitis b surface (hbs) antigen (hbsag) positive infection, or hepatitis c (anti-hepatitis c virus \[hcv\] positive) infection. * individuals with detectable cerebrospinal fluid (csf) malignant cells or brain metastases or a history of central nervous system (cns) lymphoma, primary cns lymphoma, or spinal epidural involvement. * history or presence of a cns disorder. * history of myocardial infarction, cardiac angioplasty or stenting, unstable angina, active arrhythmia, new york heart association class ii or greater congestive heart failure or other clinically significant cardiac disease within the 6 months before enrollment. * primary immunodeficiency. * history of autoimmune disease resulting in or requiring systemic immunosuppression and/or systemic disease-modifying agents within the last 2 years. * history of non-line associated, clinically significant deep-vein thrombosis or pulmonary embolism requiring therapeutic anticoagulation within the 6 months before enrollment. * females of childbearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant. females who have undergone surgical sterilization or have been postmenopausal for at least 2 years are not considered to be of childbearing potential. note: other protocol defined inclusion/exclusion criteria may apply.
exercise as a life-long medicine in patients with coronary artery disease

Conditions: Cardiovascular Diseases; Myocardial Infarction; Angina (Stable)

Summary: exercise training is a core component in cardiac rehabilitation. exercise adherence is, however, low after rehabilitation and the transition from supervised to unsupervised exercise is problematic for many patients with coronary artery disease. therefore, it is important to provide extended services to improve exercise adherence and healthy lifestyle changes. the aim of this study is to assess the effect of a time-limited intervention following out-patient cardiac rehabilitation on exercise adherence and cardiovascular risk reduction.


Eligibility criteria:
inclusion criteria: * myocardial infarction, stable angina, heart surgery * finished phase 2 cardiac rehabilitation * clinically stable * able to communicate in norwegian * able to do a maximal treadmill test exclusion criteria: * unstable angina * serious cardiac arrhythmia * serious heart valve insufficiency * heart failure * any contraindication for high intensity exercise training * participation in other exercise study * pregnancy * cognitive impairment * drug abuse

Keywords: exercise therapy rehabilitation
effect of task oriented training and xbox kinecttm on hand function in pediatric burn

Conditions: Burns; Hand Burn

Summary: the jebsen-taylor hand function test and canadian occupational performance measure (copm) were considered as primary outcome measurements. secondary outcomes included total active range of motion (rom) of the digits, hand grip strength and pinch strengths (tip, palmer and lateral pinch). all measurement was conducted at two occasions: at the baseline and after intervention.

the included participant were children with a deep partial thickness or a full thickness burn induced by either a scaled or a flame thermal burn with involvement of more than 50% of the hand and wrist, total body surface area (tbsa) less than 30% , age ranged from 7 to 14 years, recent discharge of inpatient acute care, spontaneous healing (within 34 weeks) or grafting with split thickness or full-thickness skin grafts (at least before 2 weeks). children were excluded from this study if they had infection, juvenile arthritis, fracture, tendon injuries, muscle injury, degenerative joint diseases, peripheral nerve diseases, pre - established psychologically and physically disorders (extreme aphasia, cognitive and developmental deficits that can influence the rehabilitation).

Eligibility criteria:
inclusion criteria: * children with deep partial thickness or a full thickness burn * burn induced by either a scaled or a flame thermal burn * involvement of more than 50% of the hand and wrist * total body surface area (tbsa) less than 30% * age ranged from 7 to 14 years * recent discharge of inpatient acute care * spontaneous healing (within 34 weeks) * grafting with split thickness or full-thickness skin grafts (at least before 2 weeks). exclusion criteria: * children with infection * juvenile arthritis * fracture * tendon injuries * muscle injury * degenerative joint diseases * peripheral nerve diseases * pre - established psychologically and physically disorders * extreme aphasia * cognitive and developmental deficits that can influence the rehabilitation

Keywords: children burns hand function grip strength pinch strength jebsen-taylor hand function test duruoz hand index canadian occupational performance measure