Kornimate/medical-research-clean huggingface dataset:
combined effects of core stability exercises and back strengthening exercises on pregnancy-induced back pain.

Conditions: Low Back Pain

Summary: the study will be a randomized controlled trial to check the combined effects of core stability exercises with and without back strengthening exercises in females with pregnancy-induced back pain, disability, and function so that we can examine the effect of the above techniques on pain, disability and function in pregnant females non-probability convenience sampling technique will be used, subject following eligibility criteria from society hospital nabipura lahore will be randomly allocated in two groups. group a participants will be given core stability exercises with back strengthening exercises, group b participants will be given core stability exercises for 4 weeks. assessment will be done via, numeric pain rating scale, oswestry disability index questionnaire and back pain functional scale.

pregnancy-inducedback pain causes weakness of abdominal muscles and pelvic muscles which affects core stability and back strength of pregnant women. in this study, the effects of core stability exercises with and without back strengthening exercises in pregnancy-induced back pain population will be analyzed. this study will be a randomized controlled trial. core stability exercises and strengthening exercises program would be applied to pregnant females with pregnancy-induced back pain. subjects meeting the predetermined inclusion criteria will be divided into two groups. assessment will be done using the numeric pain rating scale (nprs), oswestry disability index questionnaire, and back pain functional scale (bpfs). subjects in one group will be treated with core stability exercises with back strengthening exercises, and the other will be treated with core stability exercises only. each subject will receive a total of 20 treatment sessions, with 05 treatment sessions per week. measurements will be recorded at the start and end of the treatment session. recorded values will be analyzed for any change using spss.

Eligibility criteria:
inclusion criteria: * pregnant females * pregnant female in their second and third trimester. * multi gravida patient * low back pain intensity greater than 4 out of 10 on nprs, indicating moderate to severe. exclusion criteria: * placenta previa * bleeding or spotting * low back pain before pregnancy * pregnancy-induced hypertension * pudendal nerve entrapment syndrome. * not simultaneously partaking in pelvic floor physical therapy. * no evoked tenderness upon palpation of levatorani sling at examination.
french cohort study of chronic heart failure patients with central sleep apnoea eligible for adaptive servo-ventilation (pacewave, autoset cs, aircurve 10cs): predictive factors of poor compliance (face)

Conditions: Central Sleep Apnea; Heart Failure

Summary: the purpose of this study is to determine the predictive factors of poor compliance to sleep disordered breathing therapy in chronic heart failure patients treated for central sleep apnea. to characterize nocturia pathophysiology associated with sdb in this population. to use telemonitoring data to define predictive factors of poor compliance.


Eligibility criteria:
inclusion criteria: * adult patient with chronic heart failure * central sleep apnea requiring adaptative servo-ventilation therapy * patient is able to fully understand study information and signed informed consent exclusion criteria: * contra-indications to adaptative servo-ventilation therapy * respiratory failure or hypercapnia inconsistent with adaptative servo-ventilation therapy

Keywords: telemonitoring adaptive servo-ventilation
feasibility of an app to measure patient stressors in an intensive care unit (icu feel better app)- a before-and-after study

Conditions: Delirium

Summary: this study examines the feasibility and efficacy of a mobile application (app), which enables critically ill patients to report perceived patient stressors to their caregivers.

for many critically ill patients, treatment in an intensive care unit (icu) is very stressful, and for some of the patients it is a traumatic experience. the domains of patient stressors encompass physical stressors, mental health stressors, communication stressors, and environmental stressors. the experience of stressors during icu is associated with a higher risk of worse outcomes including delirium, delayed recovery, and post-intensive care syndrome (pics). in the context of inpatient intensive care medicine, health care professionals (hcp) have problems to correctly rate the extent of their patients' stress. in this study, we examine the feasibility and efficacy of a stressor-reporting system based on a mobile application (app), which allows critically ill patients to evaluate by themselves the intensity of their stressors, and thus, to communicate their stress experience to hcps. in the first assessment phase of this study, outcome data of a cohort of n=20 patients will be collected (cohort a). participants of cohort a will not use the icu feel better app. in the second phase, outcome data of another n=20 patients (cohort b) will be collected. participants of cohort b will have the opportunity to use the icu feel better app from the second day after admission to the icu until the day of discharge from icu.

Eligibility criteria:
inclusion criteria: * patients treated in an icu * duration of treatment ≥48h * age: 18 years and older * male, female, or divers gender exclusion criteria: * poor language skills * statement in patient letter or living will that excludes participation * participation in another prospective treatment study with indication delirium * refusal of participation
dopamine modulation of motivation and motor function in major depression & inflammation

Conditions: Depressive Disorder, Major

Summary: a large body of evidence on depression heterogeneity point to an "immunometabolic" subtype characterized by the clustering of immunometabolic dysregulations with atypical behavioral symptoms related to energy homeostasis. motivational and motor impairments reflected by symptoms of anhedonia and psychomotor retardation in major depression are closely related to alterations in energy homeostasis, are associated with increased inflammation, and may be a direct consequence of the impact of inflammatory cytokines on the dopamine system in the brain. in the proposed project, the investigators will examine the effect of dopamine stimulation on motivation and motor function in patients with major depression and healthy controls and the role of inflammation using a double-blind, randomized, placebo-controlled, cross-over design. if successful, this study would provide crucial evidence that pharmacologic strategies that increase dopamine may effectively treat inflammation-related symptoms of anhedonia and psychomotor retardation in major depression.


Eligibility criteria:
inclusion criteria: for patients with major depressive disorder: * diagnosis of major depressive disorder according to dsm-5 * free of antidepressant medication for healthy participants: * c-reactive protein (crp): ≤ 1 mg/l * free of antidepressant medication * free of any current psychiatric disorder exclusion criteria: * diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, dementia, and current/past alcohol or drug dependence * central nervous system diseases * neurological diseases * suspicious undiagnosed skin lesions or a history of melanoma * narrow-angle or wide-angle glaucoma * bronchial asthma * history of peptic ulcer disease * history of seizures * any severe somatic disease * current infections or chronic inflammatory diseases (e.g., rheumatic diseases, inflammatory bowel disease) * pregnancy / breast-feeding * class 3 obesity (body mass index of 40 or higher) * use of medication containing reserpine (certain antihypertensive agents), tricyclic antidepressants, bon-selective monoamine oxidase (mao) inhibitors, antiparkinsonian drugs, sympathomimetic drugs, tetrabenazine.

Keywords: depression inflammation anhedonia psychomotor retardation
an evaluation of tc 99m tilmanocept by intravenous (iv) and subcutaneous (sc) injection in kaposi sarcoma (ks)

Conditions: Kaposi Sarcoma; HIV Infections

Summary: to determine the safety of escalating iv doses of tc 99m tilmanocept in hiv (human immunodeficiency virus) subjects with confirmed ks and to compare results obtained from subcutaneous and iv administrations of tc 99m tilmanocept in the same subjects.

this is a manocept platform prospective, single-center, open-label, non-randomized, dose escalation, comparative, safety study of intravenously and subcutaneously injected tc 99m tilmanocept in the localization and detection of cutaneous and non-cutaneous ks tumor(s) in subjects with biopsy-confirmed ks. three iv doses (µg/mci) of tilmanocept will be evaluated in three cohort groups. one subcutaneous dose will be evaluated in cohort group 3. this study is designed to evaluate the safety and tolerability of escalating doses of iv tc 99m tilmanocept and to compare results obtained from iv and subcutaneous administrations of tc 99m tilmanocept in the same subjects. whole body planar as well as spect/ct imaging will be performed to provide greater resolution of areas of tc 99m tilmanocept localization. a biopsy of a non-visceral ks lesion will be taken to correlate pathology with tc 99m tilmanocept localization. this study is designed to evaluate the use of tc 99m tilmanocept as an imaging agent in hiv-positive subjects with known ks by evaluating localization in known and unknown cutaneous and non-cutaneous lesions.

Eligibility criteria:
inclusion criteria: 1. the subject has provided written informed consent with hipaa authorization before the initiation of any study-related procedures. 2. the subject is at least 18 years of age at the time of consent. 3. the subject is hiv positive. 4. the subject has a biopsy-confirmed diagnosis of ks and is classified into one of the categories below: 1. confirmed cutaneous ks/oral lesions without edema. 2. confirmed cutaneous ks/oral lesions with edema. 3. confirmed cutaneous ks/oral lesions with or without edema and suspected non-cutaneous ks due to clinical symptomology or confirmed non-cutaneous ks lesion(s). exclusion criteria: 1. the subject is pregnant or lactating. 2. the subject has received chemotherapy or radiation therapy to ks sites within six weeks of enrollment. 3. the subject has known sensitivity to dextran. 4. the subject has received an investigational product within 30 days prior to the tc 99m tilmanocept administration on day 1. 5. the subject has received any radiopharmaceutical within 7 days prior to the administration of tc 99m tilmanocept on day 1. 6. any condition that, in the clinical judgment of the treating physician, is likely to prevent the subject from complying with any aspect of the protocol or that may put the subject at unacceptable risk.

Keywords: kaposi sarcoma, ks, hiv
effectiveness of virtual reality training in amblyopia

Conditions: Amblyopia

Summary: the goal of this clinical trial is to evaluate the efficacy and safety of visual function training software (model: sj-jrs2021) in the treatment of mild to moderate amblyopia in children. the main questions it aims to answer are: * whether virtual reality training is more effective than occlusion therapy * safety of virtual reality training in amblyopia treatment if participants have refractive problems, correct the refraction first and wear corrective glasses. the experimental group will be treated using visual function training therapy software (model: sj-jrs2021). the control group will be treated with occlusion therapy covering the contralateral eye for 2 hours a day. researchers will compare experimental group with control group to see if the experimental group has better corrected vision recovery.


Eligibility criteria:
inclusion criteria: * age 4-7 years old (including 4 and 7 years old), both sexes; * monocular amblyopia was diagnosed; * the corrected visual acuity of amblyopia is between 0.2 (inclusive) and 0.6, and the binocular visual difference is more than 2 lines; * the guardian of the subject can understand the purpose of the trial and sign the informed consent. the subject can cooperate with the treatment and related ophthalmic examination exclusion criteria: * the subject has tumor, heart disease, hypertension and epilepsy; * the subject has an implanted electronic device, such as a pacemaker; * the subject has suffered from mental illness; * subject suffers from vertigo, fear of heights or brain trauma; * the subject has photophobia and tears caused by keratitis, conjunctivitis, internal trichiasis and other diseases at any time; * the subject has strabismus or congenital cataract, congenital ptosis, trauma and other ocular organic lesions and related surgical history; * subject has had any form of treatment for amblyopia other than refractive correction and covering treatment. * other conditions, such as severe heart, liver and kidney disease, under which the investigator considers that the patient should not participate in the trial for safety reasons or in the interest of the patient.

Keywords: amblyopia virtual reality
gonadotropin-releasing hormone agonist for the preservation of ovarian function during chemotherapy in premenopausal breast cancer

Conditions: Breast Cancer

Summary: the study is a prospective randomized control clinical trial which is sponsored by the researchers. the purpose of this study is to determine the effectiveness of gonadotropin-releasing hormone agonist on ovarian function for premenopausal breast cancer patients during chemotherapy. the premenopausal breast cancer patients will be randomly (1:1) enrolled to receive standard chemotherapy with the gnrh agonist goserelin (goserelin group) or standard chemotherapy without goserelin (chemotherapy alone group). all patients are stratified according to age (\<35years vs.36-44years), hormone receptor status (hr+ or er+ vs.hr- and er-), chemotherapy regimen(3-4 cycles vs.6-8 cycles, and cyclophosphamide-based vs.noncyclophosphamide).the follow-up time will be at least 2years. the ovarian failure, follicle-stimulating hormone, estradiol and anti-mullerian hormone, pregnancy outcomes and disease-free and overall survival will be compared between two groups to evaluate the effectiveness of protect against ovarian failure.


Eligibility criteria:
inclusion criteria: * the patients signed the written informed consent. * histologically proven stage i, ii, or iii breast cancer * must be candidates for adjuvant or neoadjuvant chemotherapy, * must be premenopausal. * trastuzumab is permitted in patients with human epidermal growth factor receptor 2 (her2) overexpressing tumors. exclusion criteria: * the patients were previous chemotherapy; * evidence of distant metastases; * other malignancies in the previous 5 years. * the patients were using gnrha, progesterone, stimulate ovulation drugs, oral contraceptives, aromatase inhibitors, intrauterine device with hormone, subcutaneous preparations contraceptive drugs such as hormone drugs and instruments during 3 month preceding the start of chemotherapy. * pregnancy or lactation.

Keywords: premenopausal breast cancer preservation of ovarian function gonadotropin-releasing hormone agonist
japan expansion cohort: evaluation of efficacy and safety of belantamab mafodotin, bortezomib and dexamethasone versus daratumumab, bortezomib and dexamethasone in participants with relapsed/refractory multiple myeloma

Conditions: Multiple Myeloma

Summary: this study is designed to evaluate safety and efficacy of belantamab mafodotin in combination with bortezomib/dexamethasone versus daratumumab in combination with bortezomib/dexamethasone in the japanese participants with relapsed refractory multiple myeloma.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of multiple myeloma as defined by the international myeloma working group (imwg) criteria. * previously treated with at least 1 prior line of multiple myeloma (mm) therapy and must have documented disease progression during or after their most recent therapy. * eastern cooperative oncology group (ecog) performance status of 0 to 2. * must have at least 1 aspect of measurable disease, defined as one of the following; 1. urine m-protein excretion \>=200 mg per 24-hour, or 2. serum m-protein concentration \>=0.5 grams per deciliter (g/dl), or 3. serum free light chain (flc) assay: involved flc level \>=10 mg per dl (\>=100 mg per liter) and an abnormal serum free light chain ratio (\ 1.65). * all prior treatment-related toxicities (defined by national cancer institute common toxicity criteria for adverse events \[nci-ctcae\] version 5.0) must be \<=grade 1 at the time of enrollment, except for alopecia. * adequate organ function exclusion criteria: * intolerant to daratumumab. * refractory to daratumumab or any other anti-cd38 therapy (defined as progressive disease during treatment with anti-cd38 therapy, or within 60 days of completing that treatment). * intolerant to bortezomib, or refractory to bortezomib (defined as progressive disease during treatment with a bortezomib-containing regimen of 1.3 mg/m\^2 twice weekly, or within 60 days of completing that treatment). note: participants with progressive disease during treatment with a weekly bortezomib regimen are allowed. * ongoing grade 2 or higher peripheral neuropathy or neuropathic pain. * prior treatment with anti-b-cell maturation antigen (anti-bcma) therapy. * prior allogenic stem cell transplant. * any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions, including renal, liver, cardiovascular, or certain prior malignancies. * corneal epithelial disease

Keywords: japan expansion cohort belantamab mafodotin relapsed/refractory multiple myeloma daratumumab bortezomib dexamethasone multiple myeloma
sglt2 inhibition in diabetes and heart failure

Conditions: Diabetes Mellitus, Type 2; Heart Failure, Systolic

Summary: to determine the effects of sglt2 inhibition with empagliflozin on cardio-respiratory fitness in patients with systolic heart failure.

the investigators hypothesize that sodium-glucose cotransporters (sglt)-2 inhibition will improve cardio-respiratory fitness (crf) in patients with systolic heart failure. participants treated with sglt2 inhibitor empagliflozin as standard of care will undergo assessments described below. the investigators will measure crf with a validated cardiopulmonary exercise test at baseline and after 4 weeks of treatment received as standard of care, to determine whether sglt2 inhibition improves cardio-respiratory fitness assessed by changes in peak oxygen consumption (vo2)(ml/kg/min) and minute ventilation (ve)/carbon dioxide production (vco2) slope, powerful independent clinical predictors of mortality in hf.

Eligibility criteria:
inclusion criteria: * confirmed clinical diagnosis of stable hf (nyha class ii-iii) on maximally tolerated hf medical regimen including angiotensin-inhibitors, beta-adrenergic blockers, and loop diuretics * reduced left ventricular systolic function (lvef\<50%) documented in the prior 12 months * poorly controlled t2dm (hba1c levels between 6.5% and 10.0%) * 18 years old and older. exclusion criteria: * type i diabetes; * type ii diabetes with episodes of severe hypoglycemia \<50 mg/dl by history, frequent changes in anti-diabetic regimen class in the past 3 months or with a prior episode of diabetic ketoacidosis (any time); * open label treatment with sglt2 inhibitors (within the past month); * treatment with thiazolidinedione (within the past month), which may induce volume and sodium retention; * chronic kidney disease (gfr\<45 ml/kg\*min); * uncontrolled thyroid dysfunction (tsh\ 4.5 mciu/ml); * pregnancy or of child-bearing potential; * active or recent (within 2 weeks) genital/urinal infection; * concomitant conditions or treatment which would affect completion or interpretation of the study including physical inability to walk or run on a treadmill such as decompensated hf (edema, nyha class iv), significant ischemic heart disease, angina, arterial hypotension (bp systolic \ 160 mmhg), atrial fibrillation with rapid ventricular response, severe valvular disease, severe chronic obstructive or restrictive pulmonary disease, moderate- severe anemia (hgb\<10 g/dl); * abnormal bp or heart rate response, angina or ecg changes (ischemia or arrhy- thmias) occurring during baseline cardio-pulmonary exercise testing; * chronic use of oral corticosteroids; * inability to give informed consent.

Keywords: sglt2 type 2 diabetes mellitus systolic heart failure heart failure with reduced ejection fraction
a prospective sub-study of the global hypophosphatasia registry

Conditions: Hypophosphatasia

Summary: in this prospective observational sub-study, participants with pediatric-onset hypophosphatasia (hpp) (perinatal/infantile- or juvenile-onset) of any age will be followed for a minimum of 5 years at sites in the united states and potentially 1 or 2 other countries.


Eligibility criteria:
inclusion criteria: * any age or sex with a confirmed diagnosis of pediatric-onset hpp (that is, first hpp sign or symptom presented at \< 18 years of age). * currently receiving asfotase alfa treatment at enrollment (not treatment-naïve) or the physician has decided to resume (not treatment-naïve) or start (treatment-naïve) the participant's asfotase alfa treatment within 6 months after enrollment. * participant must have documented alkaline phosphatase (alp) activity below the lower limit of normal for age and sex, and a documented alpl gene mutation (note: an exception is made for infants with clinical features of hpp plus low alp who need to start asfotase alfa treatment right away, at the physician's discretion, but do not yet have a genetic result. in this case, alpl gene documentation is not required at the time of sub-study enrollment but should be documented within 6 months after enrollment). * participant or participant's parent/legally authorized representative is able to read and/or understand the informed consent and study questionnaires in the local language. * participant or participant's parent/legally authorized representative must be willing and able to give signed informed consent for this sub-study, and the participant must be willing to give written informed assent, if appropriate and required by local regulations. exclusion criteria: * currently participating in an alexion-sponsored interventional clinical study. participants who have concluded participation in an alexion-sponsored asfotase alfa clinical study are eligible to enroll in this sub-study.

Keywords: pediatric onset hpp asfotase alfa