Kornimate/medical-research-clean huggingface dataset:
strength on wheels: a meal delivery and exercise intervention for homebound older adults

Conditions: Frailty

Summary: the purpose of this study is to implement a home-based exercise program, administered through interfaith ministries of greater houston meals on wheels (mowgh), and evaluate its effects on frailty status and nutritional markers in homebound older adults.


Eligibility criteria:
inclusion criteria: * enrolled in ut-health harris health house call program (hcp) * frail or pre frail by ffp * medically stable exclusion criteria: * robust by ffp * mini-cog score \<3 and/or are unable to follow instructions * pre-diagnosed terminal illness * unable to ambulate,and/or are unable to use their upper extremities

Keywords: homebound patients exercise nutrition
24 hrs histamine profile in healthy persons and patients with food intolerance

Conditions: Allergy; IBS

Summary: over 24 hrs serum and plasma samples were collected every 3 hrs. with this a day histamine profile was created. 15 healthy persons with 20 patients with a high level of ige in serum and 20 patients with afflictions but no high ige level were compared. measurment of histamine in plasma, urine and stool were realized. in addition to that diaminoxidase, tnf alpha and ige antibodies were measured.


Eligibility criteria:
inclusion criteria: * healthy subjects * appropriate invalid persons exclusion criteria: * pregnant and weaning persons

Keywords: histamine profile ige antibodies
development of the work in progress questionnaire

Conditions: Low Back Pain

Summary: the aim of this study is to describe the development of the work in progress questionnaire, a tool designed to evaluate commitment in persons, and its psychometric validation process in the context of low back pain.

the study design is cross-sectional. the following methodology will be applied as for the development of the work in progress questionnaire (wip), a tool designed to evaluate commitment in persons, and its psychometric validation: 1. item generation and selection: the first defines the content of an index and ensures the most important topics are well-thought-out. the second eliminates redundant items, and decreases the number to a total that is feasible to administer while ensuring the scale measures the construct of interest. 2. psychometric analysis: exploratory factor analysis (cattel scree test, varimax rotation), reliability (internal consistency by cronbach's alpha, test-retest reliability by intraclass correlation coefficient 2.1), measurement error (calculated by multiplying the standard error of measurement (sem) by the z-score associated with the desired level of confidence (95%, in our case) and the square root of 2), and construct validity by hypothesis testing the correlations (pearson r) with related measures (pain catastrophizing scale, oswestry disability scale, numerical pain rating scale).

Eligibility criteria:
inclusion criteria: * low back pain * adult age * reading/speaking italian. exclusion criteria: * systemic illness, mental deficits, recent cerebrovascular accidents or myocardial infarctions, chronic lung or renal diseases; * refusal to adhere.

Keywords: outcome measures commitment people psychology behavioural medicine
an applied study on the use of stone needles therapy to assist the rehabilitation of maternal diastasis rectus abdominis based on the theory of belt channel

Conditions: Diastasis Recti Abdominis

Summary: this clinical trial aims to find out whether stone needles therapy can effectively assist in the treatment of maternal diastasis rectus abdominis (dra) based on the belt channel theory, it will also validate whether the ben-tovim walker body attitude questionnaire (baq) can be used as a tool to measure body image satisfaction in chinese patients with postpartum dra. the main questions it aims to answer are: can stone needles therapy promote the recovery of maternal dra? whether the chinese version of the body attitude questionnaire (baq-c) can be used as a body image satisfaction measurement tool for patients with postpartum dra. the researchers will add stone needles therapy to neuromuscular electrical stimulation (nmes) and massage therapy to see if stone needles therapy can promote the recovery of postpartum dra.

participants will: receive nmes combined with massage therapy or the addition of stone needles therapy on a sub-basis every day for 10 days. abdominal circumference, inner rectus distance will be measured and recorded after each treatment body imagery satisfaction, low back pain and dysfunction scores, anxiety, depression scores, and quality of life scores will be measured after all treatments are completed.

Eligibility criteria:
inclusion criteria: 1. patients who meet the diagnostic criteria of postpartum rectus abdominis muscle separation, and the distance of rectus abdominis muscle separation is ≥3.0cm with postpartum low back pain. 2. patients who are \>42d postpartum and have cleaned up their discharge; 3. women who are 42day-3 mouths after normal delivery; 4. postpartum women who have not received any other treatment before treatment in our hospital; exclusion criteria: 1. with severe parenchymal organ diseases such as renal, cardiac, or hepatic diseases or due to comorbid cognitive impairment, alzheimer's disease or psychological or psychiatric diseases can not complete the cooperation, etc; 2. those with contraindications to stone therapy; 3. those with contraindications to bioelectric stimulation therapy. 4. combined with puerperal infection and gastrointestinal adhesion; 5. patients with postpartum back pain due to other reasons such as lumbar disc herniation or kidney stones; 6. patients who cannot tolerate the program;

Keywords: postpartum diastasis rectus abdominis belt channel stone needle therapy belt channel rehabilitative nursing
effect of fruit and vegetable concentrates on endothelial function in persons with metabolic syndrome

Conditions: Metabolic Syndrome

Summary: dehydrated fruit and vegetable concentrates provide an accessible form of phytonutrient supplementation that may offer cardioprotective effects. this study assessed the effects of encapsulated fruit and vegetable juice powder concentrates on endothelial function and cardiac risk markers in subjects in a randomized, double blind, placebo controlled crossover clinical trial with three treatment arms.


Eligibility criteria:
inclusion criteria: * metabolic syndrome defined by aha/nhlbi criteria * nonsmoker * not taking any other vitamins or dietary supplements * able to have blood pressure measured bilaterally at the brachial artery exclusion criteria: * any unstable medical condition that would limit the ability to participate fully in the trial * rheumatologic disease requiring regular use of nsaids * preexisting cardiovascular disease * diagnosed eating disorder * inability to complete endothelial function assessment. * use of insulin, glucose sensitizing medication, vasoactive medications (including glucocorticoids, antineoplastic agents, psychoactive agents, or bronchodilators), nutriceuticals, fiber supplements, and tobacco.
eeg-characteristics of neuropsychiatric symptoms in chronic pain

Conditions: Chronic Pain

Summary: chronic pain is a challenge for patients, physicians and society due to its high prevalence and its substantial individual and socio-economic burden. in recent years, innovative eeg-techniques have been used to study rhythmic brain activities in a variety of neuropsychiatric populations and in chronic pain and various abnormalities in neuronal oscillation patterns and connectivity between brain regions have been observed. however, it remains unclear whether these alterations of brain activity in chronic pain patients reflect pain characteristics like intensity, duration or type (e.g. neuropathic pain), or whether they reflect other symptoms associated with chronic pain. neuropsychiatric comorbidities and cognitive deficits of chronic pain are being increasingly recognized, as they frequently cause substantial problems in social life and hinder patients from being able to work. however, it has not been studied yet whether neuronal oscillations and connectivity patterns in the brains of chronic pain patients covary with neuropsychiatric comorbidities (e.g. depression, anxiety, fatigue) and cognitive functioning. to this end, the investigators will obtain resting state eeg data in large cohort of patients with chronic pain and assess clinical characteristics of chronic pain including a variety of neuropsychiatric symptoms as well as working memory capacity as a proxy for cognitive functioning. results from this study will offer valuable insights into and a better understanding of brain dysfunction of patients suffering from chronic pain. this can be helpful for diagnostic and therapeutic advances (e.g. brain stimulation and neurofeedback methods) in the near future.


Eligibility criteria:
inclusion criteria: * chronic pain condition * willing and able to sign informed consent for study participation exclusion criteria: * severe concomitant neurological or psychiatric disease * primary headache condition

Keywords: chronic pain electroencephalography neuropsychiatry working memory
the fibrin pad liver study

Conditions: Hemorrhage

Summary: the objective of this study is to evaluate the safety and and hemostatic effectiveness of the fibrin pad (fp) versus standard of care treatment (soc) in controlling parenchymal bleeding during hepatic surgery.


Eligibility criteria:
inclusion criteria: * subjects \> 18 years of age, requiring elective or urgent, open hepatic surgery * presence of an appropriate bleeding hepatic parenchymal target bleeding site (tbs) as identified intra-operatively by the surgeon * subjects must be willing to participate in the study, and provide written informed consent exclusion criteria: * subjects with any intra-operative findings identified by the surgeon that may preclude conduct of the study procedure * tbs is from large defects in arteries or veins where the injured vascular wall requires repair with maintenance of vessel patency and which would result in persistent exposure of the fp to blood flow and pressure during healing and absorption of the product * tbs with major arterial bleeding requiring suture or mechanical ligation * subjects admitted for trauma surgery * subject is a transplant patient for fulminant hepatic failure * subject with tbs within an actively infected field * bleeding site is in, around, or in proximity to foramina in bone, or areas of bony confine * subjects with known intolerance to blood products or to one of the components of the study product or is unwilling to receive blood products * subjects who are known, current alcohol and / or drug abusers * subjects who have participated in another investigational drug or device research study within 30 days of surgery * female subjects who are pregnant or nursing

Keywords: hemostasis
investigation of multi-purpose solution-based corneal staining and ocular comfort

Conditions: Myopia

Summary: the primary objective of this study is to compare subjective ocular symptoms and corneal staining over time in a group of individuals who wear soft contact lenses on a daily wear basis, whilst they sequentially use two different contact lens care regimens.


Eligibility criteria:
inclusion criteria: 1. agrees to wear the study lenses on a daily wear basis without the use of ocular lubricants. 2. has an up to date pair of glasses and is willing to wear these glasses at different times during the study. 3. is correctable to a visual acuity of 6/6 or better with their habitual correction. 4. is willing and able to follow product usage instructions and maintain the visit schedule. 5. is at least 18 years of age and has full legal capacity to volunteer. 6. can be successfully fitted with study lens type. 7. has read, understood and signed an information consent letter. 8. has a distance contact lens prescription is between -0.50 d and -9.00 d 9. has astigmatism of ≤ 1.00 d cyl 10. has normal binocular vision, i.e. no strabismus, no amblyopia, and anisometropia of ≤ 1.00d 11. has no systemic disease affecting ocular health. 12. is not using any systemic or topical medications that will affect ocular health, accommodative function, or the ocular physiological response to the contact lenses. 13. has clear corneas and no active ocular disease. 14. has no known ocular or systemic allergies, which could interfere with contact lens wear. 15. has no lid or conjunctival abnormalities, neovascularization, limbal injection, bulbar injection or corneal staining, which in the investigator's opinion is clinically significant. 16. has not worn rigid contact lenses in the last 30 days or has corneal distortion resulting from rigid lens wear. 17. has not worn extended wear contact lenses in the last 30 days. 18. has had an oculo-visual examination in the last two years exclusion criteria: 1. has any active ocular disease. 2. has any lid or conjunctival abnormalities that may, in the opinion of the investigator, interfere with the wear of contact lenses. 3. has edema, staining, clinically significant corneal opacity, dystrophy, vascularization or iritis as viewed by slit lamp. (trace or grade 1 equivalent limbal and bulbar injection or corneal staining is permissible at the discretion of the investigator.) 4. is using ocular lubricants or contact lens rewetting drops on a regular basis (at least once per day) 5. is using topical ocular prescription or any topical over-the-counter medication. 6. is actively involved in any other research/clinical study. 7. has worn rigid lenses or soft lenses on an extended wear basis within the last 30 days. 8. has had corneal refractive surgery. 9. has known sensitivity to any of the study solutions.
early post-marketing study of eliquis (apixaban) in mexico

Conditions: Deep Vein Thrombosis; Pulmonary Embolism

Summary: the primary objective of the study is to report adverse events of on-treatment aes by the treating physicians during a specified 24-month study period in patients with venous thromboembolism at the sentinel site(s) for the national center of pharmacovigilance (cnfv) in mexico.


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * patients 18 years old with dvt and pe at the sentinel site who received at least 1 dose of apixaban for the treatment and/or prevention of recurrence of dvt and pe during the specified 24-month study period exclusion criteria: * subjects who received apixaban as part of a clinical trial * subjects who received apixaban for any indication other than local approved * contraindications included in the approved mexican prescribing information
effect of biodanza on desire, excitation and sexual inhibition

Conditions: Sexual Desire Disorder; Sexual Arousal Disorder; Sexual Inhibition

Summary: the objective of this study was to examine the effects of a 10 weeks biodanza program on the sexual desire and inhibition/arousal of a sample of healthy young adults. a randomized clinical study was carried out, involving a total of 86 young adults divided into intervention group (bg) and control group (cg), carrying out biodanza sessions during 10 weeks. the sexual desire inventory (sdi) and the sexual inhibition/sexual arousal-short form scale (sis/ses-sf) were completed before and after the intervention.


Eligibility criteria:
inclusion criteria: * at least 18 years old * having correctly completed the online questionnaire. * to attend a minimum of eight biodanza sessions. exclusion criteria: * exceed 30 years old. * the presence of some type of physical or mental disability that could prevent their participation in the therapy or the completion of the questionnaires.

Keywords: biodanza libido sexual excitement sexual inhibition young adults dance therapy complementary therapies
clinical study comparing the efficacy of transbuccal paracetamol 125 mg versus paracetamol injection 1g in slow infusion iv in patients with acute pain

Conditions: Acute Pain

Summary: this is a clinical study that aims to investigate and compare the efficacy of transbuccal paracetamol 125 mg with that of paracetamol 1g administered intravenously in patients with acute pain of moderate intensity accepted to emergency room following a minor trauma of the lower limbs and/or superiors. to this end, several pain scoring will be performed using a visual analogue scale (vas) at various times after drug administration.

this is a clinical study that aims to investigate and compare the efficacy of transbuccal paracetamol 125 mg with that of paracetamol 1g administered intravenously in patients with acute pain of moderate intensity accepted to emergency room following a minor trauma of the lower limbs and/or superiors. to this end, several pain scoring will be performed using a visual analogue scale (vas) at various times after drug administration.

Eligibility criteria:
inclusion criteria: * patient admitted to emergency departments with trauma of upper or lower limbs (sprains, muscle contusions,...) associated with intensity moderate of acute pain (vas between 4 and 6) which require infusion iv of paracetamol 1g. * patient takes any chronic treatment which considered incompatible with study. * patient between 18 and 60. * male or female. * sufficient cooperation and understanding to comply to the requirements of study. * acceptance to give a written consent. * affiliation at system of french social security. * inscription or acceptation of inscription at national register of voluntaries participant at research exclusion criteria: * against paracetamol-indication: hypersensitivity known at paracétamol, antecedent hepatitis b or c, severe renal insufficiency and liver failure. * patient with medical or surgical antecedents. * patient with progressive disease at balance of inclusion. * alcoholism suspicion or toxicomany at intake. * patient who presents any inflammation or ulcerative pathology about buccal mucosa. * patient who refuses to ingest alcohol for personal reasons. * woman in childbearing age not using effective contraceptive method, pregnant or lactating woman. * patient who participated in another clinical trial, located in exclusion period or received benefits \> 4500 euros during 12 months before the beginning of trial. * patient with cooperation and understanding insufficiency to comply to the requirements of protocol * patient with social protection * no affiliation at system of french social security

Keywords: paracetamol by permucosal route, paracetamol by intraveinous route, pain. patient with minor trauma of lower limb and/or superior limb (sprains, muscle contusions, …).
study to assess safety of hdp-101 in patients with relapsed refractory multiple myeloma

Conditions: Multiple Myeloma; Plasma Cell Disorder

Summary: this study will assess the safety, tolerability, pharmacokinetics (pk) and the therapeutic potential of hdp-101 in patients with plasma cell disorders including multiple myeloma.

the study will consists of two parts: a part 1 dose escalation phase and a part 2a expansion phase for safety, tolerability, pk, pd, and clinical activity testing. the study will enroll subjects with relapsed/refractory mm or other plasma cell disorders expressing bcma. an adaptive 2-parameter bayesian logistic regression model (blrm) for dose-escalation with overdose control will be used in the dose-escalation phase for determination of the mtd or the rp2d. dose-expansion phase of the study aims to collect preliminary evidence of antitumor activity and to confirm the safety of the hdp-101 as a monotherapy.

Eligibility criteria:
inclusion criteria: * male or female aged ≥18 years. * life expectancy \>12 weeks. * eastern cooperative oncology group performance status (ps) of 0 to 2. * a confirmed diagnosis of active mm according to the diagnostic criteria established by the international myeloma working group (imwg). * must have undergone sct or is considered transplant ineligible. * must have undergone prior treatments with antimyeloma therapy which must have included an immunomodulatory drug, proteasome inhibitor, and anti-cd38 treatment, alone or in combination. in addition, the patient should either refractory or intolerant to any established standard of care therapy providing a meaningful clinical benefit for the patient assessed by the investigator. * measurable disease as per imwg criteria. * adequate organ system function as defined in protocol. exclusion criteria: * for patient entering the phase 2a part only: prior treatment with any approved or experimental bcma-targeting modalities are not allowed. * known central nervous system involvement. * plasma cell leukemia. * history of congestive heart failure. * autologous or allogenic sct within 12 weeks before the first infusion or is planning for autologous sct. * symptomatic graft versus host disease post allogenic hemopoietic cell transplant within 12 months prior to the first study treatment infusion. * radiotherapy within 21 days prior to the first study treatment infusion. * history of any other malignancy known to be active. * known human immunodeficiency virus infection. * patients with active infection requiring systemic anti-infective. * patients with positive test results for hepatitis b surface antigen or hepatitis b core antigen. * patients with positive test results for hepatitis c virus (hcv) infection. * current active liver or biliary disease.
cardiac output monitoring in critically ill patient undergoing intubation

Conditions: Hypotension

Summary: collect hemodynamic data, such as heart rate, blood pressure, and cardiac output to help understand the effect of pre and post intubation.

a non-invasive physiologic monitor, non-invasive cardiac output monitor (nicom), will be utilized for this study. this is the first completely non-invasive hemodynamic device approved by the fda and available for clinical use produced by cheetah medical and utilizes bioreactance (tel aviv, israel). it performs accurately and with precision in all patient's studied and requires only 4 adhesive gel pads on the skin to measure continuous cardiac output and to calculate stroke volume variation (svv). other physiologic data (blood pressure, total peripheral resistance (tpr), stroke volume (sv), and heart rate) will be analyzed in real time and recorded on the device and downloaded into an excel database. the data on the device will be downloaded weekly onto the excel database and deleted on the device. the study personnel will be trained in its use prior to study initiation.

Eligibility criteria:
inclusion criteria: * patients requiring endotracheal intubation in the intensive care unit. exclusion criteria: * patients previously enrolled in this study. * patients requiring intubation outside of the intensive care unit.

Keywords: intubation