Kornimate/medical-research-clean huggingface dataset:
acclimatization of healthy subjects during a stay at 3200 m

Conditions: Effects of High Altitude

Summary: the study evaluates respiratory acclimatization in healthy lowlanders staying for 3 weeks at 3200 m.

this study evaluates the effect of 3 weeks altitude acclimatization on sleep related breathing disturbances in healthy subjects staying at 3200 m. participants living in bishkek, kyrgyzstan (700 m), will be transferred by car within 4 h to the tuja ashu high altitude clinic (3200 m). outcomes will be assessed repeatedly during the stay at 3200 m.

Eligibility criteria:
inclusion criteria: * perfect health * born, raised and currently living at low altitude (\<800m) * informed consent. exclusion criteria: * any acute or chronic disease * heavy smoking (\>20 cigarettes per day).

Keywords: healthy volunteers acclimatization sleep hypoxia
long-term follow-up study for safety, efficacy and tolerability of rotigotine in adolescents with restless legs syndrome

Conditions: Restless Legs Syndrome

Summary: this is a phase 2, multicenter, open-label, single-arm, optimal dose, long-term follow-up study of monotherapy administration of rotigotine transdermal patch in adolescents with restless legs syndrome (rls). this study will assess the long-term safety and tolerability of rotigotine treatment in adolescents with rls.

study design was changed and an amendment was prepared accordingly.

Eligibility criteria:
inclusion criteria: * tolerated the first dose level of rotigotine in a previous study in adolescents with restless legs syndrome (rls), without meeting withdrawal criteria * is expected to benefit from participation, in the opinion of the investigator * subject/legal representative is considered reliable and capable of adhering to the protocol, visit schedule, and study patch application/removal, according to the judgment of the investigator exclusion criteria: * previously participated in this study * is experiencing an ongoing serious adverse event (sae) that is assessed to be related to rotigotine by the investigator or sponsor * pregnant or nursing or is a female of childbearing potential who is not surgically sterile or does not consistently use 2 combined medically acceptable methods of birth control (including at least 1 barrier method), unless not sexually active * any medical or psychiatric condition that, in the opinion of the investigator, can jeopardize or would compromise the subject's ability to participate * active suicidal ideation as indicated by a positive response ("yes") to either question 4 or question 5 of the "since the last visit" version of the columbia suicide severity rating scale (c-ssrs) of the final evaluation visit of the previous rotigotine study

Keywords: rotigotine restless legs syndrome rls long-term adolescents
biomarkers in dna samples from younger patients with newly diagnosed acute myeloid leukemia receiving gemtuzumab ozogamicin

Conditions: Leukemia

Summary: rationale: studying samples of dna from patients receiving gemtuzumab ozogamicin may help doctors learn more about the effects of gemtuzumab ozogamicin on cells. it may also help doctors understand how well patients respond to treatment. purpose: this research study is studying biomarkers in dna samples from younger patients with newly diagnosed with acute myeloid leukemia receiving gemtuzumab ozogamicin.

objectives: * to analyze candidate-coding polymorphisms in cd33 of dna samples from children with newly diagnosed acute myeloid leukemia treated with gemtuzumab ozogamicin on cog-aaml03p1. * to determine the association between these polymorphisms and clinical response of patients treated with this regimen. outline: archived dna samples are analyzed for candidate polymorphisms in cd33 by pcr-based sequencing.

Eligibility criteria:
disease characteristics: * newly diagnosed acute myeloid leukemia * treated with gemtuzumab ozogamicin on cog-aaml03p1 * genomic dna samples available patient characteristics: * not specified prior concurrent therapy: * see disease characteristics

Keywords: untreated childhood acute myeloid leukemia and other myeloid malignancies
neck dissection via a robot-assisted transaxillary approach in patients with squamous cell carcinoma of the epi-larynx

Conditions: Carcinoma, Squamous Cell

Summary: the main hypothesis of this study is that it is possible to make a unilateral selective dissection of ganglion levels iia, iii and iv using an endoscopic transaxillary approach via the da vinci robotic system to reduce scarring, while respecting patient safety. feasibility will be assessed by two combinded criteria: 1) performance of the surgical procedure respecting the different stages of visualization and dissection of key anatomical elements; 2) obtain a minimum of 9 lymph nodes when analyzing pathological evidence of the dissection.

secondary objectives include the following: a. describe certain technical variables: surgical time, extent of blood loss, need for conversion to open surgery, anesthesia procedure used, the level of difficulty and speed associated with each surgical step, length of stay, b. describe the pathological findings for each patient, c. evaluate neurological complications (function of cranial nerve pairs x, xi, xii, brachial plexus, cervical sympathetic) d. identify specific complications, e. evaluate post-operative pain, f. evaluate the scar outcome at 6 and 12 months g. describe the oncological results at 6 and 12 months.

Eligibility criteria:
inclusion criteria: * cancer of the epi-larynx: (i) ranked t1 or t2 in the tnm classification, (ii) supraglottic or glotto-supraglottic location, (iii) cn0 nodal status * absence of distant metastasis (m0) * decision for unilateral endoscopic axillary neck dissection at lymph node levels iia, iii and iv of the robins classification is retained in a multidisciplinary meeting * the patient is available for 12 months of follow-up * the patient must have given his/her informed and signed consent * the patient must be insured or beneficiary of a health insurance plan exclusion criteria: * patient participating in or having participated in another study within the previous 3 months or currently in an exclusion period determined by a previous study * adult under judicial protection or any kind of guardianship * refusal to sign the consent * it is impossible to correctly inform the patient * the patient is pregnant, parturient, or breastfeeding * preoperative diagnosis of a second location of cancerous disease * body mass index \> 25 * history of cervical spine surgery * history of instability of the cervical spine * history of surgery in the shoulder or pre-pectoral region * history of ipsilateral neck surgery * history of cervical radiotherapy * history of breast implants

Keywords: squamous cell carcinoma of the epi-larynx
study of mr-107a-02 for the treatment of acute postoperative pain following bunionectomy

Conditions: Acute Pain; Post Operative Pain; Pain

Summary: mr-107a-02 is being studied to investigate its efficacy and safety for treatment of acute pain after bunionectomy.


Eligibility criteria:
key inclusion criteria: 1. requirement for a primary unilateral bunionectomy 2. has an american society of anesthesiologists physical status of i, ii, or iii. 3. pain intensity (pi) using a numeric rating scale (nrs-r) ≥4 at any given timepoint during the 9 hours after removal of the popliteal sciatic block 4. rating of moderate or severe pain on a 4-point categorical pain rating scale (i.e., none, mild, moderate, severe) during the 9 hours after removal of the popliteal sciatic block 5. able to understand and complete the study requirements (including literacy, to enable diary and questionnaire completion), provide written informed consent, and agree to abide by the study protocol and its restrictions. key exclusion criteria: 1. previously dosed with this formulation of mr-107a-02. 2. subjects with a contralateral foot bunionectomy in the past 6 months. 3. subject has a concurrent acute or chronic painful physical/restrictive condition expected to require analgesic treatment in the postoperative period for pain that is not strictly related to the bunionectomy, and which may confound the postoperative assessments. 4. known hypersensitivity to aspirin, nsaids or other medication used in the study. 5. body mass index (bmi) \>40 kg/m2 at screening. 6. body weight of \<43 kg at screening. 7. history of gi bleeding or peptic ulcer disease. 8. known active inflammatory bowel disease, e.g., crohn's disease or ulcerative colitis. 9. a history of bleeding disorders that may affect coagulation. 10. subjects with prior stroke or transient ischemic attack in the past 12 months prior to screening.

Keywords: pain
teleassessment in neck pain

Conditions: Neck Pain; Assessment, Self; Kinesiophobia

Summary: new technologies have improved the aproach of patients with different pathologies. neck pain is a prevalent pathology in physical therapy clinics. evaluating patients with an electronical device could decrease the services saturation and the proffesionals overload.


Eligibility criteria:
inclusion criteria: * presence of neck pain * between 18 and 65 years * accepted to sign the informed consent exclusion criteria: * cognitive impairment. * traumatic accidents. * other orthopedic or neurologic pathology.
prevention of perioperative hypothermia in transurethral resection under spinal anaesthesia

Conditions: Hypothermia; Anesthesia; Perioperative Complication; Regional Anesthesia Morbidity; Temperature Change, Body; Transurethral Resection Syndrome

Summary: perioperative hypothermia is one of the most common anaesthetic complications, increasing the morbidity/mortality of our patients. active prewarming with hot forced-air devices has demonstrated to be the most effective tool to prevent hypothermia, but its use is only recommended in long-term surgeries and the optimal prewarming duration has not been elucidated. both spinal anaesthesia associated to the irrigation with liquids at low temperature instilled during transurethral resection (tur) cause a decrease in the core temperature of the patient. this is a clinical trial comparing different time periods of prewarming in patients submitted to undergo elective transurethral resection. our aim is to assess the effect of different time-periods of prewarming on preventing perioperative hypothermia during tur with spinal anaesthesia. investigators will compare different time periods: 0 minutes (control group), 15 minutes, 30 minutes and 45 minutes. 200 patients are going to be included in this study (50 patients in each group). measurement of temperature will be performed using a tympanic thermometer and zero-heat-flux temperature sensor. patients will be followed throughout their hospital admission. data will be recorded using a validated instrument and will be analysed using the statistics program r core team.

inadvertent perioperative hypothermia is probably the most common anaesthetic complication. its appearance increases the morbidity of the surgical patient, increasing the incidence of cardiac events or perioperative blood loss and causes a greater time of recovery from anaesthesia. prewarming is the most effective measure to prevent hypothermia and maintain intraoperative normothermia. however, prewarming in patients submitted to spinal anesthesia is still a weak recommendation and the optimal prewarming time has not been elucidated. due to the searching of optimal prewarming time and the lack of evidence about the efficiency of prewarming in patients submitted to transurethral resection under spinal anaesthesia, the conductance of this clinical trial is justified.

Eligibility criteria:
inclusion criteria: * patients undergoing elective transurethral resection under spinal anesthesia. * patients older tan 18 years old. * american society of anesthesiologists physical status classification i - iii. * absence of cognitive impairment. * written informed consent before enrollment. exclusion criteria: * pregnancy. * american society of anesthesiologists physical status classification iv. * active infection. * intake of antipyretics within 24 hours before surgery. * thyroid disorders. * skin lesions or history of hypersensitivity to skin contact devices.

Keywords: body temperature hypothermia prewarming regional anesthesia
remote monitoring in progressive supranuclear palsy (psp)

Conditions: Progressive Supranuclear Palsy; Parkinson Disease; MSA - Multiple System Atrophy

Summary: this is a single-arm, longitudinal, observational study on the use of wearable sensors and digital health technology to measure fall frequency and motor, speech, and cognitive function in patients with psp over the course of approximately one year. participants will perform supervised remote assessments monthly and in-person assessments approximately every 6 months.

the primary objective of this study is to determine the feasibility of using wearable sensors and digital health technology to remotely monitor patients with possible or probable psp. secondary objectives are to measure psp progression using sensor-derived motor and tablet-derived speech and cognitive measures. in brief, approximately 85 individuals with possible or probable psp, probable parkinson's disease, possible or probable multiple system atrophy, and healthy controls, will be enrolled at 4-5 sites in the u.s. and followed for one year. during the monitoring period for psp and msa participants (1 year), a wearable pendant sensor (pamsys, biosensics) will be used to monitor falls and physical activity (step counts) of all participants during activities of daily living (adl). parkinson's and healthy control participants will be seen once at baseline only. on a monthly basis, participants will have televideo conferences with the sites to perform supervised gait and balance tasks while wearing 3 legsys (biosensics) sensors. using a study-supplied tablet, participants will also perform cognitive tests including fluency, color trails and go-no-go tapping tests. participants will undergo more extensive testing every 3 months including the psprs, moca, quality of life questionnaires and functional rating scales which will be performed remotely (virtually). approximately 6 months participants will undergo an in-person psprs (to coincide with their clinic appointments).

Eligibility criteria:
inclusion criteria: * clinical diagnosis of possible or probable psp phenotype as defined by the 2017 mds criteria, clinical diagnosis of at least probable pd as defined by the 2015 mds criteria, or clinical diagnosis of at least probable msa as defined by the 2022 mds criteria, or healthy controls. * male or female, aged 18 to 89 years, inclusive. * fluent in reading and speaking english. * capable of providing informed consent based on the investigator's judgment. * able to comply with the protocol based on the investigator's judgment. * able to walk 10 feet unassisted. * with access to a caregiver who is able to assist with all study-related procedures. exclusion criteria: * any neurological, medical, or psychiatric condition that would preclude participation in study activities based on the investigator's judgment. * a history of frequent falls defined as more than 5 falls/month or requirement of a walker to ambulate safely.
outcome of patients with congenital heart disease

Conditions: Congenital Heart Disease

Summary: advanced surgical and medical healthcare systems have resulted in an increased prevalence of children and adults with congenital heart disease in western countries. these patients often necessitate non-cardiac interventions. previous studies have demonstrated that these patients are at increased risk of morbidity and mortality when presenting for non-cardiac interventions. the aim of this study is to know the prevalence of patients with congenital heart disease presenting for non-cardiac interventions in a tertiary hospital and to determine their outcome.

previous studies have shown that children and adults presenting with congenital heart disease are at increased risk of morbidity and mortality after non-cardiac interventions. this risk depends on the type of pathology, the age of the patient and the experience of the physicians in charge of these patients. we sought to determine the prevalence of children and adults with congenital heart disease presenting for non-cardiac interventions and to investigate their outcome.

Eligibility criteria:
inclusion criteria: * all children and adults with congenital heart disease exclusion criteria: * parental or patient refusal * patients presenting for cardiac interventions
the influence of personality on two aspects of cognitive performance: processing speed, and accuracy.

Conditions: Healthy

Summary: recently, a lot of evidence for a relation between measures of cognitive performance and personality characteristics has been collected. the use of computer based latency measures is often used to study mental processes in cognitive, as well as, in personality research on the basis of these relationships we can ask a question that relates to the practical usefulness (validity) of processing speed, accuracy of performance and personality measures in predicting impulsive behavior.


Eligibility criteria:
inclusion criteria: * men and women at age - 20-50 years exclusion criteria: * history of psychiatric disorders, previous hospitalizations and psychopharmacological treatments * history of alcohol and substance abuse

Keywords: personality cognitive performance the practical usefulness (validity) of processing speed, accuracy of performance and personality measures in predicting impulsive behavior
a phase 1 study of medi4736 in combination with tremelimumab in subjects with advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: this is a multicenter, open-label, dose-exploration and dose-expansion study to evaluate the safety, tolerability, antitumor activity, pk and immunogenicity of medi4736 in combination with tremelimumab in subjects with select advanced solid tumors.


Eligibility criteria:
inclusion criteria: * male and female subjects * 18 years and older * histologic confirmation of advanced solid tumors * subjects must have recurrent/metastatic disease and may have been previously treated in the recurrent/metastatic setting. exclusion criteria: * any concurrent chemotherapy, immune-mediated therapy or biologic or hormonal therapy for cancer treatment * active or prior documented autoimmune disease within the past 2 years * current or prior use of immunosuppressive medication within 14 days with some exceptions.

Keywords: advanced solid tumors durvalumab tremelimumab
risk assessment evaluation for identifying participants at high risk for stomach cancer

Conditions: Gastric Carcinoma

Summary: this clinical trial evaluates the usefulness of various risk assessment tests, including helicobacter pylori (h. pylori) breath testing, questionnaires, and endoscopies for identifying participants at high risk for stomach cancer. h. pylori is a bacteria that causes stomach inflammation and ulcers in the stomach. people with h. pylori infections may be more likely to develop cancer in the stomach. h. pylori breath testing can help identify the presence of h. pylori infection in a participant and help identify if the participant may be at a higher risk of developing stomach cancer. an endoscopy uses a thin, flexible lighted tube that is inserted inside the esophagus, stomach, and first part of the small intestine. this allows the doctor to see and look for abnormal areas that may need to be biopsied. risk assessment including h. pylori evaluation, questionnaires, and endoscopies may help identify participants at high risk for stomach cancer and may be a useful screening tool for earlier stomach cancer diagnosis.

primary objective: i. to determine the feasibility of using community outreach and clinical assessment to identify persons at high risk for gastric cancer. secondary objectives: i. to determine the presence of gastric cancer (gc) associated risk factors amongst the diverse ethnic populations (in greater orange and los angeles counties). ii. to determine the proportion of high-risk patients who are willing to undergo upper endoscopy. iii. to identify actionable diagnoses on upper endoscopy of high-risk individuals. exploratory objective: i. to assess population-based understanding of gastric cancer. outline: part i: participants complete questionnaires, undergo collection of a blood sample, and undergo an h. pylori breath test for gastric cancer risk assessment at baseline. part ii: high-risk participants are assigned to cohort i and non-high risk participants are assigned to cohort ii. cohort i: participants may undergo esophagogastroduodenoscopy (egd) with possible tissue biopsy within 3 months of baseline risk assessment and complete questionnaires annually up to 3 years. cohort ii: participants complete questionnaires for re-assessment annually up to 3 years and may undergo egd at year 2. participants are followed up annually for a total of 3 years.

Eligibility criteria:
inclusion criteria: * documented informed consent of the participant and/or legally authorized representative * assent, when appropriate, will be obtained per institutional guidelines * age: ≥ 40 years to ≤ 80 years * identify as a racial minority either asian, hispanic, or black american * willingness to: * provide blood samples and undergo upper endoscopy exclusion criteria: * identify as non-hispanic white * history of gastric cancer * known premalignant lesions of the stomach * history of upper endoscopy within 2 years * women of childbearing potential: pregnant/ nursing * an employee who is under the direct/indirect supervision of the principal investigator (pi)/a coinvestigator/the study manager * a direct study team member
effect of fermented soy based product on cardiometabolic risk factors

Conditions: Cardiovascular Risk Factor; Heart Diseases; Inflammation

Summary: this research study will test the effects of q can plus powder on serum lipids, selected inflammatory and oxidative parameters and genome-wide methylation

the purpose of this research study is to investigate the effects of a dietary supplement from soybeans that might help in managing heart disease. the rationale for this study is to reduce the risk factors of heart disease in high risk individuals by using soy supplements. the dietary supplement intervention trial is a randomized, 2x2 cross over design with 24 subjects in free-living conditions. there will be a two week run-in (acclimation period) after which subjects will be randomized to receive either qcan powder or placebo powder for 12 weeks. following a two week wash out period, subjects will be switched over(cross over) to alternate treatment. thus, the interventions of the study will last for a total of 28 weeks.

Eligibility criteria:
inclusion criteria: * men and women 29-75 years of age * at high risk for cardiovascular disease, i.e. with 2 or more risk factors: * present tobacco smoker * arterial hypertension (bp ≥ 140/90 mm hg or treatment) * ldl-cholesterol ≥ 110 mg/dl * hdl-cholesterol ≤ 40 mg/dl * triglycerides ≥ 150 mg/dl * fasting blood glucose ≥ 110 mg/dl * overweight or obesity (bmi ≥ 25 kg/m2) * family history of premature heart disease exclusion criteria: * uncontrolled renal, hepatic, or endocrine disease * abnormal blood chemistry profile * familial hypercholesterolemia or other genetic dyslipidemia * intake of lipid-lowering drugs and dietary products including plant sterols/stanols * high framingham risk or medical condition in which statin therapy is considered necessary by a treating physician * hypersensitive or allergic to soy or cellulose * alcohol or drug addiction or abuse * diabetes * lack of ability or interest to follow the dietary intervention

Keywords: fermented soy cardiovascular disease inflammation dna methylation