Kornimate/medical-research-clean huggingface dataset:
bryostatin-1 plus cisplatin in treating patients with recurrent or advanced cancer of the cervix

Conditions: Cervical Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. combining more than one drug may kill more tumor cells. purpose: phase ii trial to study the effectiveness of bryostatin-1 plus cisplatin in treating patients who have recurrent or advanced cancer of the cervix.

objectives: i. determine the safety and efficacy of bryostatin-1 plus cisplatin in patients with recurrent or advanced carcinoma of the cervix. ii. determine the response rate, progression free interval, and duration of survival of these patients when treated with this regimen. outline: this is a multicenter study. patients receive bryostatin-1 iv over 1 hour and cisplatin iv over 1 hour on day 1. treatment continues every 21 days in the absence of disease progression or unacceptable toxicity. patients are followed until death. projected accrual: a total of 37 patients will be accrued for this study over 2-3 years.

Eligibility criteria:
disease characteristics: histologically confirmed recurrent or advanced carcinoma of the cervix not amenable to surgery or radiotherapy squamous cell or adenocarcinoma or adenosquamous carcinoma measurable disease brain metastases treated with surgery or radiotherapy allowed if no residual symptoms or medications (e.g., anticonvulsants, corticosteroids) patient characteristics: age: over 18 performance status: ecog 0-2 life expectancy: at least 3 months hematopoietic: granulocyte count at least 1,500/mm3 platelet count at least 100,000/mm3 hemoglobin greater than 9 g/dl hepatic: bilirubin less than 1.5 times upper limit of normal (uln) ast/alt less than 2.5 times uln renal: creatinine no greater than 1.5 mg/dl cardiovascular: no severe cardiac dysfunction or arrhythmia other: not pregnant or nursing negative pregnancy test fertile patients must use effective contraception no concurrent unstable medical illness, infection, or other significant medical problem no clinically apparent neuropathy, including hearing loss no psychological, familial, sociological, or geographical conditions that may preclude study prior concurrent therapy: biologic therapy: not specified chemotherapy: prior neoadjuvant chemosensitization therapy allowed at least 3 weeks since prior chemotherapy (6 weeks since prior mitomycin or nitrosoureas) and recovered prior cisplatin therapy allowed no prior chemotherapy for advanced disease endocrine therapy: no concurrent corticosteroids radiotherapy: at least 2 weeks since prior radiotherapy and recovered surgery: prior surgery allowed other: no concurrent anticonvulsants no concurrent antiarrhythmic medication

Keywords: stage iii cervical cancer recurrent cervical cancer stage ivb cervical cancer stage iva cervical cancer cervical squamous cell carcinoma cervical adenocarcinoma cervical adenosquamous cell carcinoma
effect of monitoring continuous glucose levels and physical activity via wearables on cardiovascular risk factors

Conditions: Coronary Heart Disease; Physical Activity; Cardiovascular Risk Factors

Summary: the study aims to assess the effect of smart watches and continuous glucose measuring devices on cardiovascular risk factors.

within a period of 4 months 100 patients will be recruited and randomised to the intervention or control arm (1:1) for a duration of 3 months. randomisation will be stratified by age, sex, bmi, diabetes, blood pressure, and duration after finishing cardiac rehabilitation. patients randomised to the intervention arm will be given a smart watch as well as a continuous blood glucose measurement device with detailed instructions. at baseline and at the end of the study questionnaires will be answered and anthropomorphic measurements attained. blood samples will be drawn at baseline and after an intervention period of 3 months in all subjects. additional data on sleep, temperature, heart rate (resting and exercise), breathing rate, activity and exercise, oxygen saturation and daily weight will be collected through the fitbit web application programming interface (api).

Eligibility criteria:
inclusion criteria: * informed consent signed by the subject * completed outpatient cardiac rehabilitation * diagnosis of coronary heart disease * access to a smartphone for the duration of the study * 18 years or older on the date of consent exclusion criteria: * diseases which limit physical activity including angina with incomplete revascularisation, arrhythmogenic cardiomyopathy, stroke with residual disease, and major orthopaedic disorders * known or suspected non-compliance * inability to follow the procedures of the investigation, e.g., due to language problems, psychological disorders, dementia, etc. of the subject * diabetic patients receiving insulin therapy * lack of proficiency with smart phone/watch * current participation in any other clinical trial, which may confound the results of this trial. * nyha (new york heart association) class iii or iv congestive heart failure * pregnancy

Keywords: blood pressure lipids glucose level smoking weight diet
effects of donepezil hcl on task-activated fmri brain activation in healthy older adults at genetic risk for alzheimer's disease

Conditions: Genetic Risk for Alzheimer's Disease

Summary: this study examines the sensitivity of functional mri to detect brain changes caused by donepezil hcl (a cholinesterase inhibitor) in healthy older adults at genetic risk for alzheimer's disease.

this 24-week study will examine the sensitivity of functional mri to detect brain changes caused by donepezil hcl (a cholinesterase inhibitor) in healthy older adults at genetic risk for alzheimer's disease. participants with a family history of alzheimer's disease will be eligible for this study. participants without a family history of ad will also be enrolled to serve as a control group.

Eligibility criteria:
inclusion criteria: * normal general cognitive function * high risk group only: family history (1st degree relative) of ad * low risk group only: no family history (1st or 2nd degree relative) of ad * visual and auditory acuity adequate for neuropsychological testing exclusion criteria: * current or past history of * neurological illnesses/conditions * head trauma with significant loss of consciousness * medical illnesses/conditions that may affect brain function * severe psychiatric disorder * substance abuse * unstable or severe cardiovascular disease or asthmatic condition * history of stroke or transient ischemic attack
heat acclimation, hand cooling efficacy, and adaptation maintenance.

Conditions: Heat

Summary: this study had three aims: 1. to determine the impact of consecutive days of exercise on thermoregulation and cardiovascular strain. 2. to determine the efficacy of a hand cooling device to cool individuals throughout a heat acclimation period. 3. to assess the maintenance of thermoregulatory and cardiovascular adaptations derived from heat acclimation during a 25-day intermittent exercise-heat exposure protocol.

participants completed 14 days of exercise heat acclimation in either a hot or cool environment, followed by a heat or cool exercise exposure every 5th day for 25 days. cardiovascular, thermoregulatory, and perceptual strain were measured throughout exercise each day. hydration assessment and stress response via blood biomarkers were measured before and after exercise. aerobic capacity was measured before and after heat acclimation as well as after the intermittent exercise-heat exposure. hand cooling was implemented periodically during exercise-heat stress visits to determine cooling efficacy before and after heat acclimation.

Eligibility criteria:
inclusion criteria: * no chronic health problems * no previous history of exertional heat stroke within the past 3 years * no history of cardiovascular, metabolic or respiratory disease * no current musculoskeletal injury that limits physical activity exclusion criteria: * women * exercise less than once per week * vo2max \< 45 ml/kg/min
the comparison of target controlled infusion of propofol or etomidate at general anesthesia in geriatric patients

Conditions: Adrenal Suppression; Hemodynamic Instability

Summary: compare the efficacy and safety of closed-loop target controlled infusion of propofol or etomidate at general anesthesia in geriatric patients


Eligibility criteria:
inclusion criteria: 1. written informed consent. 2. scheduled for endotracheal intubated and general anesthesia for general surgery patients. 3. age 60-75 yrs. 4. american society of anesthesia (asa) classification i-ii. 5. expected time of surgery is less than 3 hours. - exclusion criteria: 1. body mass index is more than 36kg/m2. 2. systolic blood pressure≥180 mm hg or \<90 mm hg，diastolic blood pressure≥110 mm hg or \< 60 mm hg. 3. serious cardiac,cerebral,liver,kidney,lung, endocrine disease or sepsis. 4. long term used hormone or adrenal suppression. 5. allergy to trial drug or other contraindication. 6. difficult airway occurred before,or difficult airway possibly occurred and difficult to extubation. 7. abuse of narcotic analgesia or suspected. 8. neuromuscular diseases. 9. mentally unstable or has a mental illness. 10. malignant hyperthermia. 11. pregnant or breast-feeding women. 12. attended other trial past 30 days. -
a safety and efficacy study to evaluate amg 531 treatment in subject with myelodysplastic syndrome receiving revlimid

Conditions: Myelodysplastic Syndromes; Thrombocytopenia

Summary: this is a dose and schedule finding study of amg 531 designed to assess the activity of amg 531 to reduce the rate of clinically significant bleeding and blood transfusions in subjects with myelodysplastic syndrome (mds) receiving lenalidomide. subjects with mds that are planned to receive at least four cycles of lenalidomide for treatment of their disease are appropriate to screen for this study. all subjects meeting the eligibility criteria will receive lenalidomide 10 mg capsule by mouth daily every day of each 28-day cycle. subjects will receive amg 531 or placebo once a week by subcutaneous injection for 16 weeks.


Eligibility criteria:
inclusion criteria: * diagnosis of mds by bone marrow biopsy based on the world health organization (who) classification * low or intermediate-1 risk category mds using the ipss * planned to receive lenalidomide 10 mg capsule by mouth daily for all 28 days of each cycle for at least 4 cycles * eastern cooperative oncology (ecog) performance status of 0-2 * subjects must be at least 18 years of age or older exclusion criteria: * prior exposure to \>3 cycles of lenalidomide * exposure to lenalidomide within the last 30 days * prior history of leukemia or aplastic anemia * prior history of stem cell transplantation * prior malignancy (other than in situ cervical cancer or basal cell cancer of the skin) unless treated with curative intent and without evidence of disease for 3 years before randomization * active or uncontrolled infections * unstable angina, congestive heart failure \[nyha \> class ii\], uncontrolled hypertension \[diastolic \> 100 mmhg\], uncontrolled cardiac arrhythmia, or recent (within 1 year) myocardial infarction * history of arterial thrombosis ( eg, stroke or transient ischemic attack) in the past year * history of venous thrombosis in the past year * received il-11 within 4 weeks of screening * less than 4 weeks since receipt of any investigational drug or device * have previously received any other thrombopoietic growth factor * pregnant or breast feeding * subjects of reproductive potential who are not using adequate contraceptive precautions, in the judgment of the investigator * known hypersensitivity to any recombinant e coli-derived product

Keywords: revlimid lenalidomide low platelet count low risk myelodysplastic syndrome intermediate 1 myelodysplastic syndrome mds myelodysplastic syndrome
mr-guided adaptive radiotherapy combined with pd-1 antibody and capox for locally advanced rectal cancer

Conditions: Locally Advanced Rectal Cancer

Summary: neopulsar is a prospective, randomized phase ii trial. 46 larc (t3-4/n+m0, distance from anal verge ≤12cm) patients will be treated with mr-guided adaptive radiotherapy (30gy/6fx) combined with 6 cycles of toripalimab and capox. tme surgery is scheduled after tnt. the primary endpoint is pathological complete response (pcr) rate. the secondary endpoints include the grade 3-4 acute adverse effects (ae) rate, anal function, surgical complication, 3-year lrfs rate, 3-year dfs rate, 3-year os rate, etc.


Eligibility criteria:
inclusion criteria: 1. age 18-70 years old, male or female 2. pathologically confirmed rectal adenocarcinoma 3. the distance from anal verge ≤ 10 cm 4. clinical stage t3-4 and/or n+ 5. no evidence of distance metastases 6. msi/mmr status: mss/pmmr 7. karnofsky score \>=70 8. adequate organ function and have no contraindications to surgery, radiochemotherapy, or immunotherapy 9. no chemotherapy or any other anti-tumor therapy prior to enrollment 10. no immunotherapy prior to enrollment 11. with good compliance during the study 12. signed written informed consent exclusion criteria: 1. known history of other malignancies within 5 years， except cured skin cancer and cervical cancer in situ 2. pregnancy or breast-feeding women 3. individuals with a history of uncontrolled epilepsy, central nervous system disease, or psychiatric disorders that, in the judgment of the investigator, are of such clinical severity that they may prevent the signing of an informed consent form or affect the patient's adherence to oral medications 4. individuals with clinically serious (i.e., active) heart disease, such as symptomatic coronary artery disease, new york heart association (nyha) class ii or worse congestive heart failure or severe arrhythmia requiring pharmacologic intervention, or history of myocardial infarction within the last 12 months 5. individuals with a history of organ transplantation requiring immunosuppressive therapy and long-term hormone therapy 6. individuals with autoimmune diseases 7. individuals with severe uncontrolled recurrent infections，or other severe uncontrolled concomitant diseases 8. baseline hematology and biochemistry not meeting the following criteria: hb≥90g/l; neu ≥1.5×109/l; plt ≥100×109/l; alt, ast ≤2.5 times the upper limit of normal; alp ≤2.5 times the upper limit of normal; tb \<1.5 times the upper limit of normal; cr \<1 time the upper limit of normal; alb ≥30g/l 9. individuals with dihydropyrimidine dehydrogenase (dpd) deficiency 10. individuals allergic to any drug component of the study
bedtime sublingual tnx-102 sl as fibromyalgia intervention therapy (bestfit)

Conditions: Primary Fibromyalgia

Summary: tnx-102 capsules \[formerly known as very low dose (vld) cyclobenzaprine\] at bedtime have shown promise as a treatment of fibromyalgia, but the drug required new formulation technology for bedtime use. the present trial was designed to assess the safety and efficacy of tnx-102 sl 2.8 mg tablets, taken daily at bedtime over 12 weeks to treat fibromyalgia.


Eligibility criteria:
inclusion criteria: * diagnosis of primary fibromyalgia (acr criteria) * male or female 18-65 years old * for patients with major depressive disorders only: clinically stable, no suicidal risk and stable anti-depressent therapy * willing and able to withdraw specific therapies (ask pi) * medically acceptable form of contraception (female only) * signed informed consent exclusion criteria: * arthritis, lupus and other systemic auto-immune diseases * regional or persistent pain that could interfere with assessment of fibromyalgia pain * bipolar and psychotic disorders * increased risk of suicide * significant clinical (cardiac, systemic infection, systemic corticosteroid requirement, drug/alcohol abuse) or laboratory abnormalities. * inability to wash-off specific medications (ask pi) * known hypersensitivity to cyclobenzaprine * others: seizure disorders, sleep apnea, continuous positive airway pressure (cpap) use, bmi\>40

Keywords: pain sleep
effectiveness of child centered counseling on child nutrition status

Conditions: Malnutrition

Summary: hypothesis n°1: the "children growth promotion based on approach centered on their specific needs" enhances caretakers and health workers skills, knowledge and practices on breastfeeding, complementary feeding and child care. hypothesis n°1: children growth promotion based on approach centered on their specific needs" approach improves children growth and health.


Eligibility criteria:
-inclusion criteria: all women of childbearing age in the third trimester of pregnancy, living in the study area for at least one year at the time of the inclusion and who gave informed consent. exclusion criteria:

Keywords: cluster randomized trial, nutrition counseling, caretaker's knowledge child growth, prevention, acute malnutrition
fx shoulder prospective clinical study

Conditions: Osteoarthritis Shoulder; Rotator Cuff Syndrome of Shoulder and Allied Disorders; Fracture, Shoulder

Summary: prospective multi-center registry on study subjects with implanted devices marketed and legally commercialized in the usa by fx shoulder solutions.

to evaluate patient outcomes following shoulder replacement with fx shoulder solutions medical devices and demonstrate effectiveness, safety and survivorship of fx shoulder solutions medical devices. to provide data and analysis to fx shoulder solutions to meet regulatory requirements. to provide data and analysis for presentations, abstracts, publications and other public release of results. a patient is considered a success at minimum of 2 years post-operative follow-up based upon the following composite clinical success (ccs): * adjusted constant score that is ≥ 54 and improvement of ≥ 10 points from baseline confidential fx shoulder post-market follow-up clinical protocol version 1.0 04 aug 2022 9 * no continuous radiolucency or device migration/subsidence * no revision surgery * no serious device related adverse event the registry will continue to follow patients to 5 years post-operative to track survivorship.

Eligibility criteria:
inclusion criteria: receive an fx shoulder replacement medical device in accordance with the indications for use for the selected device system. exclusion criteria: patient who does not meet the inclusion criteria.

Keywords: osteoarthritis roartator cuff fracture
study of different gating techniques for pet image of lung and liver lesions

Conditions: Lung; Nodule; Liver Metastases

Summary: lesions blurred by respiratory motion are common in fluorine-18 pet/ct studies. to avoid these artefacts, several standard gating correction technics are available. the investigator aimed to compare the impact of different gating techniques based on phase, amplitude, elastic-motion monitored with and without pressurre sensor device on standardized uptake value (suvmax and suvpeak) and uptake volume (uv) measurements on different sizes of pulmonary and liver lesions. the feasability of this study will be done using anthropomorphic coupled with a motion phantom and on a series of patients.

pet-ct images will be acquired on a biograph vision600 pet/ct, fitted with 26cm axial field of view and time of flight. phantom study will use an anthropomorphic torso phantom with a programmable motion phantom, mimicking respiratory motion (quasar). spheres with various internal diameters will be introduce into the lungs (air density) adding an axial mechanical device simulating breathing movement of +/-20mm. concentration in the spheres will be the same for all diameters. the background and liver activities will be approximatively respectively 38 and 14 mbq. this phantom will be a simulating patient only for lung lesions. the investigator will compare 6 different pet acquisitions: standard 3min acquisition without movement as our reference of "trues suvmax and uv", 3min acquisition with simulated breathing movement without any gating and 3min with respectively gating techniques based on phase, amplitude, elastic-motion monitored with and without pressurre sensor device. patient study will be on 50 consecutive patients with lung or liver nodules. 18f-fdg injection will be around 2.5 mbq/kg. the investigator will compare 5 different pet acquisitions: standard acquisition with free respiratory movement as our reference of "trues suvmax and uv", acquisitions with respectively gating techniques based on phase, amplitude, elastic-motion monitored with and without pressurre sensor device.

Eligibility criteria:
inclusion criteria: * presence at least of one hepatic or lung nodule exclusion criteria: * none

Keywords: positron emission tomography nodule uptake gating quantification
evaluation of a remotely guided physical preparation by a physical activity teacher adapted with the help of a smartwatch before bronchial cancer surgery

Conditions: Lung Cancer

Summary: this is a study of a preoperative rehabilitation program with remotely guided high-intensity exercises by physical activity teachers adapted to a smartwatch in patients with operable lung cancer.


Eligibility criteria:
inclusion criteria: * major patient, age ≥ 18 * patient with non-small cell operable bronchial cancer without indication of neo-adjuvant chemotherapy * affiliated with a social security plan * vems \< 80% and/or dlco\<80% * high-intensity training achievable for at least 10 days before surgery * acceptant to participate in the protocol * ability to follow the stimul program of education focused on adapted physical activity * have a smartphone that can download the mobile app * have the ability to understand, read and write french exclusion criteria: * patient unable to consent: under guardianship or curatorship * patient refusing surgery * non-operable patient due to comorbidities or unseable tumour * poor understanding of the smartwatch * severe cognitive or psychiatric disorders * pregnancy in progress

Keywords: smartwatch, lung cancer operation, physical exercices
effects of armeo power robot therapy on upper limb recovery in hemiplegic stroke patients

Conditions: Rehabilitation of Upper Limb Motor Function in Hemiplegia Due to Supratentorial Cerebral Infarction Using Armeo Power Robot

Summary: this study investigates the effectiveness of combining armeo power robotic therapy with conventional rehabilitation techniques to improve upper limb motor function in patients with hemiplegia caused by supratentorial cerebral infarction (a type of stroke). the study aims to evaluate how robotic-assisted therapy can enhance recovery by measuring motor function improvements over three weeks of treatment. participants will undergo standard physical and occupational therapy alongside armeo power training, with results compared to those receiving only standard rehabilitation. the findings aim to provide valuable insights into advanced therapeutic options for stroke rehabilitation.


Eligibility criteria:
inclusion criteria * spasticity of the affected arm with a modified ashworth scale score ≤ 2. * patients must have good cognition and awareness (moca score ≥ 26). * patients must have good vision and visual perception. * patients must have stable sitting posture and good sitting balance. * body weight and affected arm size must be compatible with the robotic arm device. * patients must agree to participate in the study and adhere to the training protocol. exclusion criteria * spasticity with a modified ashworth scale score ≥ 3. * severe sensory impairment in the affected limb. * patients with arthritis or joint stiffness. * hemiplegia caused by conditions other than stroke. * pre-existing motor disabilities in the affected limb before the stroke. * skin lesions on the limb requiring rehabilitation. * uncontrolled epilepsy.

Keywords: robot armeo power, upper extremity function, rehabilitation, ischemic stroke