Kornimate/medical-research-clean huggingface dataset:
assessment of tremor using snumap motion sensing system

Conditions: Tremor

Summary: the purpose of this study is to record and measure tremor using portable six-axis (tri-axial accelerometer and tri-axial gyroscope) motion sensing system.

snumap system is portable, finger-worn, battery powered device that contains mems (micro-electro-mechanical system) hybrid motion sensor (three-axis accelerometer and three-axis gyroscope). the snumap device consists of a wrist module and finger module, which attaches to an patients's finger and transmits three dimensional motions to a wrist module for storage and further analysis. the aims of this study is to assess tremor severity using tri-axial accelerometry and gyroscope to determine the reliability and the correlation with clinical measurements.

Eligibility criteria:
inclusion criteria: * age: 20-80 years * patients with tremor (involuntary, rhythmic, oscillatory movement in one or more body part) * subject who signed an informed consent exclusion criteria: * pregnant or nursing woman. * comorbid neurologic illnesses that impact the ability to perform the study tasks. * subjects with medical condition that in the opinion of the investigator would affect his/her ability to participate in this study.

Keywords: tremor snumap accelerometry gyroscope clinical rating scale
intervention for fatigue in hct recipients

Conditions: Hematologic Cancer; Hematologic Malignancy

Summary: the purpose of this study is to assess whether a cognitive-behavioral therapy (cbt) for fatigue intervention is acceptable, feasible, and effective at managing fatigue and improving quality of life for patients following hematopoietic stem cell transplant (hct).

this research is being done to determine whether a cognitive-behavioral therapy (cbt) for fatigue intervention is feasible and effective at managing fatigue and improving quality of life in patients following hematopoietic stem cell transplant. an open pilot of 6 participants will precede the randomized controlled trial. study procedures for the open pilot include screening for eligibility, intervention zoom sessions, questionnaires, and exit interviews with study staff. patients participating in the subsequent randomized controlled trial will be randomized into one of two study groups: cbt for fatigue intervention versus usual care.study procedures include screening for eligibility, intervention zoom sessions (intervention arm) or receipt of informational materials about fatigue (usual care arm), and completion of study questionnaires (after consent but before randomization and at approximately 3 and 5 months post-randomization). this research study is expected to last about 3 years. it is expected about 66 people will take part in this research study. the national heart, lung, and blood institute of the national institute of health is providing funding for this project.

Eligibility criteria:
inclusion criteria * adult patients (≥ 18 years) * have the ability to speak and read english * have undergone autologous or allogeneic transplant \> 6 months prior to enrollment * no evidence of disease relapse requiring therapy * no new other malignancy requiring therapy after transplant * report moderate to severe fatigue in the past week (fsi average severity item rating ≥ 4 of 0-10) * are currently receiving their care at the mgh blood and marrow transplant clinic exclusion criteria * patients with active cognitive impairment or uncontrolled psychiatric illness such as schizophrenia that the treating clinician believes prohibits informed consent or participation in the intervention * patients already receiving cbt care * patients living with untreated sleep apnea * patients with hypoxemia requiring oxygen supplementation

Keywords: hematologic cancer hematologic malignancy hematopoietic stem hct cognitive behavioral therapy cbt
a study of cabozantinib (xl184) vs everolimus in subjects with metastatic renal cell carcinoma

Conditions: Renal Cell Carcinoma

Summary: the purpose of this study is to evaluate the effect of cabozantinib (xl184) compared with everolimus (afinitor) on progression-free survival (pfs) and overall survival (os) in subjects with advanced renal cell cancer that has progressed after prior vegfr tyrosine kinase inhibitor therapy.


Eligibility criteria:
select inclusion criteria: 1. documented histological or cytological diagnosis of renal cell cancer with a clear-cell component. 2. measurable disease as determined by the investigator. 3. must have received at least one vegfr-targeting tki (eg, sorafenib, sunitinib, axitinib, pazopanib or tivozanib). 4. recovery from toxicities related to any prior treatments, unless ae(s) are clinically nonsignificant and/or stable on supportive therapy. 5. adequate organ and marrow function. 6. sexually active fertile subjects(male and female)must agree to use medically accepted methods of contraception during the course of the study and for 4 months after the last dose of study treatment. 7. female subjects of childbearing potential must not be pregnant at screening. select exclusion criteria: 1. prior treatment with everolimus, or any other specific or selective torc1/pi3k/akt inhibitor (eg, temsirolimus), or cabozantinib. 2. receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before randomization. 3. receipt of any type of anticancer antibody (including investigational antibody) within 4 weeks before randomization. 4. radiation therapy for bone metastasis within 2 weeks, any other external radiation therapy within 4 weeks before randomization. systemic treatment with radionuclides within 6 weeks before randomization. subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible. 5. known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery and stable for at least 3 months before randomization. 6. concomitant anticoagulation at therapeutic doses with oral anticoagulants or platelet inhibitors. 7. chronic treatment with corticosteroids or other immunosuppressive agents. 8. serious illness other than cancer. 9. major surgery within 3 months before randomization. complete wound healing from major surgery must have occurred 1 month before randomization and from minor surgery at least 10 days before randomization. 10. pregnant or lactating females. 11. diagnosis of another malignancy within 2 years before randomization, except for superficial skin cancers, or localized, low grade tumors.

Keywords: renal cell cancer kidney vascular endothelial growth factor receptor 2 (vegfr2) tyrosine kinase inhibitor hepatocyte growth factor receptor protein (met) von hippel-lindau gene
the efficacy of the karl storz curved fetoscope and straight fetoscope for laser photocoagulation of placental anastomoses

Conditions: Twin to Twin Transfusion Syndrome

Summary: the purpose of this study is to evaluate the efficacy of karl storz curved fetoscope (11508aak) and its straight version (11506aak) for laser photocoagulation of placental anastomoses in patients with an anterior placenta and twin to twin transfusion syndrome (ttts).


Eligibility criteria:
inclusion criteria: * pregnancy * the patient fulfills the criteria for laser photocoagulation of placental anastomoses based on the standard of care * fetal diagnosis of twin-to-twin transfusion syndrome * anterior placenta * the patient provides signed informed consent that details the maternal and fetal risks involved with the procedure exclusion criteria: * contraindication to abdominal surgery, fetoscopic surgery, or general anesthesia * allergy or previous adverse reaction to a study medication specified in this protocol * the patient does not fulfill the conventional criteria to undergo in-utero surgery, which is specific for each surgery * preterm labor, preeclampsia, or a uterine anomaly (e.g., large fibroid tumor) that is unavoidable during surgery in the index pregnancy * fetal aneuploidy, genomic variants of known significance if an amniocentesis has been performed, other major fetal anomalies or disorders that may impact the fetal/neonatal survival, or a known syndromic mutation * suspicion of a major recognized syndrome by ultrasound or mri * maternal bmi \>40 kg/m2 * high risk for fetal hemophilia
serial, non-invasive analysis of exhaled breath condensate in ventilated trauma patients

Conditions: Ventilator Associated Pneumonia (VAP)

Summary: to determine if the analysis of exhaled breath condensate correlates with the development \& resolution of pneumonia.

this proposal investigates the utility of exhaled breath condensate fluid (ebcf) collected from heat moisture exchange (hme) filters connected to patient's endotracheal tubes for early, non-invasive detection of ventilator-associated pneumonia (vap) in critically ill or injured icu patients. the development of pneumonia during mechanical ventilation is the most common healthcare-associated infection in severely injured patients, accounting for substantial morbidity, excess icu and hospital stay, additional cost and increased mortality.

Eligibility criteria:
inclusion criteria: * age 18 or older * admitted to the vanderbilt trauma (ticu) and surgical intensive care units (sicu) * mechanically ventilated for ≥2 successive days (without planned extubation within 24 hours of enrollment) exclusion criteria: * less than 18 years of age * expected survival less than 24 hours * anticipated extubation within 24 hours of enrollment * conditions limiting the subject's ability to tolerate collection of lavage specimens, including: fio2 \> 80%; peep \> 16 cmh2o; intracranial pressure \>20 cmh2o; tracheal or mucosal bleeding; platelet count \ 2.0 * known prisoners * pneumonia diagnosis at the time of icu admission

Keywords: trauma ventilator surgical icu
a study exploring brain activity in relation to sensory arm impairments in the early stages of stroke

Conditions: Stroke

Summary: this clinical study is organized for people with stroke often experience difficulties with their sensation in their upper limb. new technologies may be able to help these important problems. however, there is currently not enough knowledge about how the brain recovers in people with sensory impairments in their arm and hand. using a non-invasive technique of recording brain activity, known as electroencephalography (eeg), brain activity in combination with somatosensation of the hand will be measured. therefore, the purpose of this study will be to analyse brain activity in relation to somatosensory impairments after stroke during the first two weeks after stroke.


Eligibility criteria:
participants will be recruited during the first 2-3 days post-stroke. they should have: 1. a first-ever unilateral, supra-tentorial stroke, as defined by wold health organisation; 2. admission to the acute hospital, 3. deficit in distal pinprick somatosensory measured by rivermead assessment of somatosensory performance (score of ≤4) and/or motor impairment measured by fugl meyer assessment (score of ≤12 out of 14), 4. the age of \> 18 years and 5. the ability to provide informed consent. healthy adults will also be recruited and they should have: 1. no history of sensory impairments in their hands 2. the age of \> 18 years and 3. the ability to provide informed consent.

Keywords: upper limb recovery somatosensory impairment electroencephalography acute phase
the effect of surgery for non endometriosic ovarian cysts on ovarian reserve

Conditions: Antimullerian Hormone; Ovarian Cysts; Antral Follicle Count

Summary: the main objective is to evaluate the ovarian reserve after laparoscopic cystectomy. the secondary objective is the analysis of predictors of change in the ovarian reserve after surgery


Eligibility criteria:
inclusion criteria: * patients with non endometriosis ovarian cysts * age between 15-40 years * regulars menses * signed informed consent exclusion criteria: * patients with previous surgery, * patients with infertility, * patients with endometriosis or * patients with suspicious of malignance
observational study of botulinum toxin type a in patients with urinary incontinence associated with overactive bladder

Conditions: Urinary Bladder, Overactive; Urinary Bladder, Neurogenic

Summary: this study will describe the prescription conditions of botulinum toxin type a (botox®) injection for the treatment of urinary incontinence due to neurogenic detrusor overactivity (ndo) or idiopathic overactive bladder (ioab) as per standard of care in clinical practice in france.


Eligibility criteria:
inclusion criteria: -patients who receive a botox® injection for urinary incontinence. exclusion criteria: -patients not residing in france.
evaluation of the relevance of pharmacogenetics in the prescription off antidepressants in a military population

Conditions: Depression; Anxiety; Ptsd

Summary: the treatment of depression, anxiety disorders and post-traumatic stress disorder (ptsd) is a main public health problem due to the frequency of these pathologies and the very partial effectiveness of the existent therapies. these illnesses generally require the prescription of several successive lines of antidepressant treatments before the treatments actually become effective, leading to a several week delay during which the patient suffers from the symptoms of his/her pathology and is also likely to experience the side effects of the treatment. pharmacogenetics is an individualized prescribing modality that aims to predict the most favorable treatment for a given individual based on the study of genetic variants of cytochromes. the main hypothesis of this research is that the use of pharmacogenetics in routine practice in a population of military personnel requiring a first prescription of an antidepressant is of interest to improve the tolerance and effectiveness of the treatment.


Eligibility criteria:
inclusion criteria: * between 18 and 65 years-old; * to benefit from a medical follow-up in the psychiatric department of an army training hospital; * to present a pathology requiring an antidepressant treatment and whose prescription can wait 10 days; * to have given written informed consent to participate in the study. exclusion criteria: * to be currently treated with an antidepressant or antidepressant stopped less than 15 days ago; * to have one or more contraindication to the introduction of an antidepressant treatment; * pregnancy or breastfeeding; * to require a measure of constraint.

Keywords: antidepressants pharmacogenetics
comparison of arthroscopic supraspinatus tendon tear repair in patients over 60 years with and without patch augmentation.

Conditions: Rotator Cuff Tears

Summary: the aim of the study is to show that patch augmentation in rotatorcuff tear results in lower rate of recurrent tendon defects compared without patches.

an arthroscopic rotator cuff repair is nowadays mostly implemented in order to restore function and reduce or eliminate pain. the primary objective of this randomized controlled trial is to demonstrate, in patients 60 years or older with a large rotator cuff tear, that biological or synthetic patch augmen-tation in arthroscopic rotator cuff repair results in decreased rate of retear 24 months post-operatively compared to re-pair without patch augmentation.

Eligibility criteria:
inclusion criteria: * rotator cuff tear \> 2 cm in the sagittal plane involving the supraspinatus tendon as well as at least the superior 1/3 of the infraspinatus tendon * indicated for surgical reconstruction by arthroscopy * patient aged 60 years and over * consenting participation in this study by signing the informed consent form exclusion criteria: * osteoarthritis (grade ≥ 2 after samilson \& prieto) * advanced fatty infiltration of the rotator cuff muscles (goutallier grade iii or iv) * tear of the subscapularis \> typ 1 lafosse (partial tears of superior 1/3 of the tendon) * irreparable tear of the supraspinatus * general medical contraindication to surgery * known hypersensitivity to the materials used * revision operations * open reconstruction * tendon transfer necessary (latissimus dorsi or pectoralis major) * any disease process that would preclude accurate evaluation including: * systemic arthritis, rheumatoid arthritis, diabetes (insulin dependent), acute or chronic infection, abnormal bone metabolism, tumour / malignoma, psychiatric disorder * inadequate blood flow or neuromuscular disease in the affected arm * recent history of substance abuse * legal incompetence * german language barrier to complete the questionnaires or * participation in any other medical device or medicinal product study that could influence the results of the present study
study of bd pre-filled flush syringes in china

Conditions: Effectiveness and Safety of Pre-filled Flush Syringe

Summary: this study is to compare the bd posiflush™ pre-filled flush syringes (manufactured by bd, usa) and evaluate the effectiveness and safety of the pre-filled flush syringes (manufactured by suzhou becton dickinson medical devices co., ltd.) for locking and flushing the end of catheter line in chinese popluation.


Eligibility criteria:
inclusion criteria: * 1. age \>or equal to 18, no limitation on gender; 2. hospitalized patients; 3. patients who are anticipated to need or have in situ vascular access catheter devices (this may include: peripheral intravenous catheter (pivc), central venous catheter (such as peripherally inserted central catheter (picc)); 4. patients who are expected to require flushing the vascular access catheter with saline at the beginning, during, or end of infusion therapy, or who require to flush and/or lock vascular access catheters at the beginning, during, the end of drug therapy; 5. patients who can understand the purpose of the trial, agree to participate in this clinical trial and voluntarily sign the informed consent form. exclusion criteria: * 1. patient reports pregnancy or lactation (self-report); 2. subjects who are known to have blockage or recanalization of vascular access prior to this trial. 3. subjects who are known to have uncomfortable symptoms such as redness and pain, or common complication associated with indwelling catheter such as phlebitis and infection at the localized insertion site prior to this trial. 4. patient participating in another drug or medical device clinical trial at the time of consent or has participated in a drug or medical device clinical trial within three months before enrollment; 5. any other situation that, in the option of the investigator would make the patient considered unfit for this study.
a post-market clinical trial for access and visualization of the oropharynx, hypopharynx and larynx during transoral procedures

Conditions: OSA; Oral Disease; Oropharyngeal Neoplasms; Hypopharyngeal Neoplasms

Summary: the objectives of this study are to evaluate the performance of the medrobotics flex® robotic system to visualize and access specific anatomical locations along with evaluation of the safety of the device.


Eligibility criteria:
inclusion criteria: * ≥ 22 years of age * candidate for transoral surgery in the oropharynx, hypopharynx and larynx exclusion criteria: * less than 22 years of age * not a candidate for transoral surgery in the oropharynx, hypopharynx and larynx

Keywords: transoral oropharynx hypopharynx endoscopic tors endoscopic transoral larynx
safety and efficacy of trans sodium crocetinate (tsc) with radiation and temozolomide in newly diagnosed glioblastoma

Conditions: Glioblastoma; GBM; Glioma

Summary: this open-label study evaluated the safety and efficacy of tsc when dosed concomitantly with the standard of care (radiation therapy and temozolomide) for newly diagnosed glioblastoma in adults. all patients received tsc in the study. the objective of the study was to evaluate the effect of tsc on survival and tumor response in patients with gbm while establishing an acceptable patient risk profile.

the overall objectives of this phase 1/2 clinical study in newly diagnosed gbm patients was to evaluate the safety and tolerability, efficacy, pk profile, pfs/time to disease progression, qol, and overall survival in adults when tsc is added to the standard of care regimen of radiation therapy and temozolomide. all patients received tsc in this study. the primary objective of the phase 1 portion of the study was to evaluate the safety (dlt rate) and to define the dosing regimen of tsc for the larger phase 2 study. the primary clinical endpoint was overall survival at 24 months and patients will be followed for up to 3 years.

Eligibility criteria:
inclusion criteria: * aged at least 18 years of age; male or female. a patient who is 70 years of age or older may be considered for enrollment after review of patient clinical and laboratory data by the protocol medical monitor. * histologically confirmed diagnosis of gbm. * contrast enhancing disease on mri within 21 days prior to screening. * karnofsky score (kps) of ≥ 60 at screening. * no prior rt, chemotherapy (including gliadel wafer), immunotherapy or therapy with a biologic agent, or hormonal therapy. glucocorticoid therapy is allowed. * within 2 weeks of baseline visit, hematologic and renal functions as specified: absolute neutrophil count ≥ 1500/mm3, platelets ≥ 100,000/mm3, hgb ≥ 9.0g/dl, creatinine ≤ 1.7mg/dl, total bilirubin ≤ 1.5mg/dl, blood urea nitrogen (bun) within 2 times the upper limit of normal, transaminases ≤ 4 times above the upper limits of the institutional norm. * sexually active patients must use an acceptable method of contraception while receiving doses of study medication. * females of childbearing potential must have a negative serum or urine pregnancy test at screening and have additional pregnancy tests during study. exclusion criteria: * patient who cannot undergo mri. * pregnant or lactating. * serious concurrent infection or medical illness that would jeopardize the ability of the patient to receive study treatment with reasonable safety. * patient receiving concurrent chemotherapeutics or investigational agents within 30 days of baseline assessments, including gliadel wafers or gliasite application.

Keywords: primary brain tumor glioblastoma glioma gbm radiation therapy