Kornimate/medical-research-clean huggingface dataset:
sym004 vs standard of care in subjects with metastatic colorectal cancer

Conditions: Metastatic Colorectal Cancer

Summary: this is a phase 2, open-label, randomized, 3-arm trial investigating the efficacy of two sym004 doses (arm a and arm b) compared with a control group (arm c) in subjects with metastatic colorectal cancer (mcrc) and acquired resistance to anti-epidermal growth factor receptor (egfr) monoclonal antibodies (mabs).

this trial assesses the efficacy of two different weekly dosing regimens of sym004 (arm a: 12 mg/kg/week versus arm b: 9 mg/kg loading dose followed by 6 mg/kg/week) compared with investigator's choice in terms of overall survival time in subjects with mcrc. subjects assigned to arm c will receive best supportive care (bsc), fluorouracil (5-fu), or capecitabine, per local standard of care. subjects will receive treatment until unacceptable toxicity, disease progression, withdrawal of consent, or until the subject meets any of the criteria for treatment discontinuation or trial discontinuation. therefore, the duration of treatment will differ among individuals and cannot be fixed in advance.

Eligibility criteria:
inclusion criteria: * written informed consent obtained before undergoing any study-related activities * male or female, at least 18 years of age * subjects with histologically or cytologically confirmed mcrc, kirsten rat sarcoma wild-type (kras wt) at initial diagnosis * failure of or intolerance to 5-fu, oxaliplatin, and irinotecan * acquired resistance to marketed anti-egfr mabs as defined in the protocol * measurable disease defined as one or more target lesions according to recist * life expectancy of at least 3 months * eastern cooperative oncology group (ecog) performance status less than or equal to 1 * other protocol defined inclusion criteria could apply exclusion criteria: * pretreatment with regorafenib. * subjects who in the opinion of the subject and investigator would benefit more from regorafenib treatment (except where regorafenib is not reimbursed in the country) * skin rash common terminology criteria for aes (ctcae) grade greater than 1 from previous anti-egfr therapy at time of randomization * magnesium less than 0.9 milligram per deciliter (mg/dl) * known hypersensitivity to any of the treatment ingredients. known previous grade 3-4 infusion related reactions with anti-egfr mabs * other protocol defined exclusion criteria could apply

Keywords: metastatic colorectal cancer best supportive care capecitabine fluorouracil (5-fu) sym004
whole genome sequencing of tuberculosis for disease control in madagascar

Conditions: Tuberculosis

Summary: tuberculosis (tb) whole genome sequencing (wgs) allows outbreak identification and disease transmission tracking. it is hypothesized that prospective wgs-guided epidemiological investigations improve case detection compared to current best practices by adapting contact tracing strategies to local transmission patterns. a cluster randomized controlled trial (crct) will be performed in high tb incidence villages of haute matsiatra region in madagascar. communities will be randomized in three separate tb control strategies comparing (1) standard of care, (2) the world health organization (who) recommended best practices and (3) a novel intervention involving tb wgs cluster-guided epidemiological investigations. the incremental value of tb wgs on case notifications and reduction of tb burden will be measured. secondary studies will be nested within this crct will include: * a qualitative study which will increase the understanding of the factors facilitating and hindering implementation of wgs-based diagnostics within health systems. * a cost effectiveness analysis study which will measure the cost effectiveness of newly implemented laboratory methods. field and genomic epidemiology data from this project will inform future work on the design of community-level tb elimination strategies in collaboration with madagascar national tb program


Eligibility criteria:
inclusion criteria: * subjects suspected tb * subject living in the study area exclusion criteria: * unable to take a sputum sample

Keywords: whole genome sequencing cluster randomized controlled trial
efficacy of suvorexant in the treatment of insomnia in midlife women with pre-diabetes

Conditions: Insomnia; Diabetes; Menopause

Summary: the aim of this study is to determine if suvorexant can help treat the severity of insomnia in midlife women who are pre-diabetic.

the purpose of this research study is to investigate if suvorexant can help treat the severity of insomnia (a chronic sleep disorder) in midlife women who are pre-diabetic, and to learn whether improvement in insomnia symptoms is linked with improvement in blood sugar levels. this is a double-blind, randomized placebo-controlled crossover trial. study procedures are conducted over a 14-week period (2-week screening period, 4-week treatment period \[block 1\], 4-week washout, and 4-week treatment period \[block 2\]). during each treatment block, participants take a daily pill - during one block, they take suvorexant and during the other block, they take a placebo (randomized to the order). primary data collection includes blood draws, monitoring glucose and lipid levels, actigraphy, questionnaires, and daily diaries.

Eligibility criteria:
inclusion criteria: * healthy women aged 40-65 years * postmenopausal or late perimenopausal * meets criteria for insomnia disorder * score on the insomnia severity index (isi) measure ≥15 * subjective and sustained sleep disruption during screening * hot flashes present, including at night * pre-diabetic per guidelines from the american diabetes association exclusion criteria: * diagnosis of other primary sleep disorders * shift worker * frequent use of hypnotic medications * unwillingness to refrain from taking any sleep medications during the study period * current major depressive episode * suicidal ideation * lifetime history of bipolar disorder, psychosis, or other serious mental health problem * current alcohol/substance use disorder * current or prior diagnosis of diabetes mellitus * use of an insulin sensitizer or a pharmacologic treatment for pre-diabetes * extreme obesity * current use of systemic hormonal therapies * renal or hepatic disease * pregnancy or breastfeeding * recent malignancy * recent surgery * neurological disorder or cardiovascular disease raising safety concerns * medical instability considered to interfere with study procedures * concomitant medications with drug interaction or co-administration concerns * contraindications or allergic responses to suvorexant * recent travel across time zones * excessive coffee or cigarette use * unwilling to limit alcohol, nicotine, and caffeine consumption during study
merging yoga and occupational therapy for parkinson disease: phase 2

Conditions: Parkinson Disease

Summary: the full program is focused on identifying and reducing risk factors surrounding falls. based on previous research, we believe that occupational therapy group classes and adaptive yoga are an ideal pairing to reduce fall risk. the occupational therapy sessions will consist of lecture, group discussion, and activities designed to target biological, behavioral, environmental, and socioeconomic factors that contribute to fall risk specifically for people with parkinson's disease.


Eligibility criteria:
inclusion criteria: * individuals with a diagnosis of parkinson's disease or their care partners * individuals who read and understand english * individuals who can stand with or without an assistive device * people who are willing to commit to yoga practice 2x/week for 8 weeks and pay $5/class through raintree athletic club (scholarships are available if needed!) * people who are willing to commit to group occupational therapy 2x/week for 8 weeks free of charge * score of at least 4/6 on the short mini mental status exam exclusion criteria: * less than 18 years of age
beverage consumption and fine motor control

Conditions: Body Weight

Summary: the aim of this study will be to compare the effects of daily consumption of aspartame, rebaudioside a, saccharin, sucralose, and sucrose on body weight and composition in a standardized protocol. the investigators hypothesize that individual low calorie sweeteners (consumed in a beverage) differ from each other in promoting weight loss and decreased fat mass (without energy restriction or dietary guidance) based on their chemical structure.


Eligibility criteria:
inclusion criteria: * bmi between 25-40 kg/m2 * non or rare users of lcs * willing to consume large volumes of beverages daily exclusion criteria: * weight change \> 3kg in the last year * plan to initiate a new diet plan in the next 6 months * exhibit eating restraint * pregnant/lactating

Keywords: energy intake energy expenditure appetite
comprehensive nano - post market clinical follow-up study

Conditions: Osteoarthritis; Avascular Necrosis; Rheumatoid Arthritis; Revision; Correction of Functional Deformity

Summary: this data collection project is intended to provide clinical outcomes data to engineering, marketing as well as fulfill the post market surveillance requirements of various regulatory authorities. the study will be a prospective and one-arm.

the comprehensive® shoulder system with nano humeral component is a humeral prosthesis system intended for use in total or hemi shoulder arthroplasty surgery. total shoulder arthroplasty consists of replacement of the humeral head and glenoid. hemi-arthroplasty consists of replacement of only the humeral head. this project is a prospective study including one-hundred and fifty (150) anatomic and hemi cases and 44 reverse shoulders collected from up to ten (10) sites. all potential study subjects will be required to participate in the informed consent process.

Eligibility criteria:
inclusion criteria: * non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. * rheumatoid arthritis * revision where other devices or treatments have failed * correction of functional deformity. * difficult clinical management problems where other methods of treatment may not be suitable or may be inadequate * difficult clinical management problems where other methods of treatment may not be suitable or may be inadequate exclusion criteria: * infection * sepsis * osteomyelitis

Keywords: osteoarthritis avascular necrosis rheumatoid arthritis
ccb safety study in treatment of hypertension of adpkd

Conditions: Kidney, Polycystic, Autosomal Dominant

Summary: this study examines the safety and efficacy of calcium channel blocker (ccb) in the treatment of hypertension of autosomal dominant polycystic kidney disease (adpkd) patients. angiotensin receptor blocker (arb) was shown to have kidney protecting effects in patients with renal diseases including adpkd, glomerulonephritis and diabetic nephropathy. in case whose blood pressure is not normalized by arb alone, ccb is selected additionally. recent research suggests genetic calcium channel disorder is responsible for the progression of adpkd. it is not examined clinically if ccb treatment has any harmful effect to patients with adpkd. this study examines the safety of cilnidipine (ccb) in the adpkd patients whose blood pressure is not controlled under 130/85 mmhg by candesartan (arb) alone.


Eligibility criteria:
inclusion criteria: * adpkd patients. * blood pressure measured at out-patient setting is above 130/85 mmhg. * age between 20 and 60 years old. * plasma creatinine less than 2.0mg in man and 1.5mg in woman. * patients give informed consent. exclusion criteria: * patients with severe cardiovascular and hepatic disorders. * patients with complications of central nervous vascular disorders. * women who are breast feeding and females of childbearing potential who are not using acceptable contraceptive methods. * patients currently engaging in other experimental protocol. * patients with intracranial aneurysma. * patients who must use diuretics. * allergic patients to candesartan or cilnidipine. * patients whose hypertension is not controlled by medication of this protocol.

Keywords: autosomal dominant polycystic kidney disease hypertension angiotensin-2 receptor blocker calcium channel blocker kidney volume
perfusion index vs positional hemodynamic changes to predict hypotension after spinal anaesthesia in caesarean section

Conditions: Post Spinal Hypotension

Summary: comparative study between the perfusion index and positional haemodynamic changes for prediction of hypotension after spinal anaesthesia in caesarean section

hypotension following spinal anaesthesia may cause maternal dizziness, nausea, vomiting and fetal acidosis, administration of prophylactic vasopressor agents in pregnant women may cause undesirable effects on the mother and fetus. perfusion index is the ratio of a pulsatile to a non-pulsatile fraction of blood volume. the increase of the pulsatile fraction manifested during vasodilatation corresponds to a higher pi. so, the patients with a higher pi have a higher risk for post-spinal hypotension. elevated sympathetic activity before neuraxial anaesthesia was associated with a higher risk for post-spinal hypotension. the significant variability in haemodynamic after the positional change indicates higher sympathetic activity. the high the rise in autonomic activity, the higher the risk for post-spinal hypotension aim of the work: prediction of hypotension after spinal anaesthesia in caesarean section either by perfusion index and positional haemodynamic changes grouping: all the recruited patients will be assessed by perfusion index. and by positional haemodynamic changes

Eligibility criteria:
inclusion criteria * parturient acceptance. * american society of anesthesiologists (asa) ii * arturient with be gestational age \>36 weeks and \<41 weeks. * body mass index (bmi) ≤35kg/m2 * elective caesarean section delivery exclusion criteria * preeclampsia * eclampsia, * gestational diabetes * contraindication to regional anaesthesia as allergy, coagulation abnormalities or infection in site of injection.
gastrocinemius function massage on lower extemity spasticity

Conditions: Stroke; Stroke Ischemic

Summary: this study aimed to investigate gastrocinemius function massage on physical parameters of stroke patients.

gastrocinemius function massage is known to relieve pain and increase range of motion. however, its effects on spasticity and physical performance in stroke patients are not fully understood. in this study, we aimed to investigate the effects of gastrocinemius function massage.

Eligibility criteria:
inclusion criteria: * having experienced a stroke at least 6 months prior, * being able to stand independently for at least 1 minute, * scoring at least 23 on the standardised mini-mental state examination (smmse), indicating no significant cognitive impairment , and * having lower extremity spasticity rated between 1-3 on the modified asworth scale * at least 18 years of age. exclusion criteria: * comorbidities such as neurological, orthopaedic, metabolic, and rheumatological diseases that could potentially impact soft tissues. * patients who had received spasticity or other treatments that could affect soft tissues within the past 3 months, * those with lower extremity injuries, and those with a diagnosis of cancer or who were pregnant.

Keywords: spacticity, gastrocinemius function massage, stroke, gait
evaluation of vestibular functions and balance in edirne band musicians

Conditions: Vestibular Disorder

Summary: it has been stated that intense noise may affect the peripheral vestibular system and consequently cause problems in balance mechanisms. the aim of this study was to investigate the effects of exposure to chronic noise on vestibular functions and balance in edirne band musicians. twenty-two individuals working in the edirne band for at least 5 years and over 18 years of age and a control group of 22 individuals working at trakya university and with similar sociodemographic characteristics to the experimental group were included. the socio-demographic questionnaire was used to inquire about the demographic characteristics of individuals and alcohol-cigarette use, the activity-specific balance confidence scale to assess how they felt about the balance, and the dizziness handicap inventory to determine the quality of life-related to dizziness. a 3d ultrasonic system was used to assess the static and dynamic balance of the individuals.

chronic exposure to intense noise causes temporary or permanent hearing loss. the effects of exposure to intense noise on the auditory system are well explained, but the number of studies that observes the effects of noise on the vestibular system is limited. it has been stated that intense noise may affect the peripheral vestibular system and consequently cause problems in balance mechanisms. the aim of this study was to investigate the effects of exposure to chronic noise on vestibular functions and balance in edirne band musicians. twenty-two individuals working in the edirne band for at least 5 years and over 18 years of age who did not have a diagnosed vestibular disorder, no cervical vertebrae problem, no musculoskeletal system problems during the evaluation and a control group of 22 individuals working at trakya university and with similar sociodemographic characteristics to the experimental group were included in the study. the socio-demographic questionnaire was used to inquire about the demographic characteristics of individuals and alcohol-cigarette use, the activity-specific balance confidence scale to assess how they felt about the balance, and the dizziness handicap inventory to determine the quality of life-related to dizziness. a 3d ultrasonic system was used to assess the static and dynamic balance of the individuals.

Eligibility criteria:
inclusion criteria: * over 18 years of age * had at least for 5 years of experience at the edirne band * volunteering to participate in the study exclusion criteria: * diagnosed vestibular disease * cervical spine problems during the evaluation * musculoskeletal problems during the evaluation

Keywords: noise balance quality of life
effect of enteral nutrition support for critically ill patients

Conditions: Respiratory Distress Syndrome,Adult; Acute Lung Injury

Summary: to determine whether specialized enteral nutrition support can improve oxygenation status in critically ill patients with acute lung injury (ali) or acute respiratory distress syndrome (ards) comparing to a standard enteral nutritional formula.


Eligibility criteria:
inclusion criteria: 1. male or non-pregnant female. 2. ali or ards 3. pao2/fio2 \> 100 and ≤ 300 torr. 4. evidence of bilateral pulmonary infiltrates/opacity on chest radiograph. 5. enteral access 6. systemic inflammatory response syndrome (sirs) - two or more of the following must be present: 1. body temperature less than 36°c or greater than 38°c 2. heart rate \> 90 beats per minute 3. tachypnea with \> 20 breaths per minute; or an arterial partial pressure of carbon dioxide \< 4.3 kpa (32 mmhg) 4. white blood cell count \ 12,000 cells/mm³; or the presence of \> 10% immature neutrophils. exclusion criteria: 1. dialysis for renal failure 2. unable to initiate enteral feeding within 48 hours since all inclusion criteria met. 3. anticipated life expectancy less than 24 hours. 4. patient with severe chronic liver disease 5. neuromuscular disease that impairs ability to ventilate without assistance 6. head trauma and/or drowning with a glasgow coma score of 5 7. receiving intravenous lipid emulsions from parenteral nutrition within 12 hours of baseline. 8. receiving propofol 9. airway reconstructive surgery. 10. malignancy or irreversible disease for which 6-month mortality is greater than 50%. 11. burns greater than 25% total body surface area. 12. unwillingness or inability to utilize the ards network ventilation protocol. 13. hiv positive. 14. chronic mechanical ventilation. 15. severe, acute pancreatitis. 16. refractory shock 17. congestive heart failure with pulmonary edema as the primary cause of hypoxemia. 18. acute myocardial infarction or cardiac surgery within 7 days. 19. solid organ transplant. 20. inr \> 5.0 or platelet count \< 30,000/mm3 or history of bleeding disorder. 21. intracranial hemorrhage within the past 30 days.
emdr psychotherapy for anxious-depressive symptoms in breast cancer patient

Conditions: Breast Cancer Female

Summary: the study will consist in an evaluation of the emdr (eye movement desensitization and reprocessing) psychotherapy in the context on invasive primitive breast cancer. emdr could then allow the affected patients to readjust their point of view on the pathology and thus promote more adapted behaviors or additional resources to cope with the disease. 190 patients are going to be randomized in two groups : one group with emdr psychotherapists and one group with support psychotherapists. patients will receive 8 sessions. we expect that patient in emdr psychotherapists group will have an higher decrease of anxiety score, depressive score (ces-d) and ptsd score, and a higher increase in quality of life.

the study will consist in an evaluation of the emdr psychotherapy in the context on invasive primitive breast cancer. emdr could then allow the affected patients to readjust their point of view on the pathology and thus promote more adapted behaviors or additional resources to cope with the disease. 190 patients are going to be randomized in two groups : one group with emdr psychotherapists and one group with support psychotherapists. patients will receive 8 sessions. we expect that patient in emdr psychotherapists group will have an higher decrease of anxiety score, depressive score and ptsd score, and a higher increase in quality of life (qlq)

Eligibility criteria:
inclusion criteria: * being a 18 or more year old woman * having primary breast cancer or going to start treatment or having completed treatments for less than 6 months * presenting a state-anxiety level a score higher than 35. * being able to complete questionnaires. * having signed the consent letter * be affiliated to a social security system exclusion criteria: * have contraindications for emdr psychotherapy (neurological disorders, dissociative states, oculomotor problems) * have metastatic breast cancer * physical multiple pathologies * have a psychiatric history (including anxio-depressive disorders). background assessment from m.i.n.i. (sheehan et al., 1997) * present an addiction, an abuse of drugs or alcohol * person placed under the protection of justice, guardianship or trusteeship. * pregnant or lactating woman

Keywords: breast cancer support psychotherapy emdr therapy anxiety disorders