Kornimate/medical-research-clean huggingface dataset:
avatrombopag usage in nsaa

Conditions: Aplastic Anemia; Drug Effect

Summary: this is a multicenter, open-label, prospective one arm study to explore the efficacy and safety of avatrombopag in non-severe aplastic anemia. patients meeting the inclusion and exclusion criteria would be recruited. treatment of avatrombopag would be started with 20mg/day. the dosage would be increased by 20 mg/day every 2 weeks if the platelet count remains less than 20×10e9/l and reduced if the platelet count reaches over than 150×10e9/l. the dosage could range from 20mg/week to 60mg/day. all patients would receive treatment for at least 6 months except that the platelet \<20×10e9/l at the dosage of 60mg/day for 4 weeks or the platelet ≥200×10e9/l at the dosage of 20mg/week for 2 weeks. the hematological response rate and safety will be recorded and compared at every month after starting the study treatment. the patients would be followed up for at least 6 months.


Eligibility criteria:
inclusion criteria: 1. patients diagnosed to be non-severe aplastic anemia 2. patients have at least one of the followings: ①absolute neutrophil count \< 1.5×109/l, ②platelet count \< 30×109/l, ③ hemoglobin level \< 100g/l 3. patients have no response or relapsed following at least one treatment course in a period time of \> 6 months of immunosuppression containing csa or csa+anti-thymocyte globulin (atg); 4. eastern cooperative oncology group (ecog) performance status 0-2; 5. patients able to understand and comply with protocol requirements and instructions and have signed and dated informed consent. exclusion criteria: 1. congenital aplastic anemia; 2. presence of chromosomal aberration; 3. evidence of a clonal hematologic bone marrow disorder (mds, aml) on cytogenetics; 4. presence with pnh clone ≥50%; 5. patients received hsct before; 6. uncontrolled infection or bleeding with standard treatment; 7. allergic to avatrombopag or accessories; 8. hiv, hcv or hbv active infection or liver cirrhosis or portal hypertension; 9. patient with qtcf (fridericia's qt correction formula) at screening \ 180/100mmhg)，pulmonary artery hypertension; 10. have any concomitant malignancies within 5 years expect for local basal cell carcinoma of the skin; 11. past history of thromboembolic event, heart attack or stroke (including anti-phospholipid antibody syndrome) and current use of anticoagulants; 12. pregnant or nursing (lactating) woman; 13. have attended other clinical trials within 3 months;
metabolic and microbial profiling of lung cancer

Conditions: Nonsmall Cell Lung Cancer; Nonsmall Cell Lung Cancer Stage

Summary: this pilot study will establish non-invasive sample collections, including breath, saliva, blood and urine pre-surgery and at the participant's one-month post-surgery follow-up visit. participants with suspected non-small cell lung cancer (nsclc) stage i-iii will be recruited.

primary objective * to evaluate the feasibility of adding non-invasive sample collections in the pre-surgical setting and at the post-surgery follow-up visit. * to identify and assess metabolic and microbial signatures collected at pre- and post-surgery and determine which are indicative of lung cancer. secondary objective * to identify signatures which are associated with lung cancer stage. * to identify signatures which are impacted by patient's pulmonary function status.

Eligibility criteria:
inclusion criteria: * male and female patients age \>18 years, of all racial and ethnic origins, with suspected nonsmall cell lung cancer stages i, ii, and iii, as evident through radiographic evidence and felt acceptable to undergo surgical resection. * patients who have the ability to understand and the willingness to sign a written consent form. exclusion criteria: * patients who are have taken antibiotics within two weeks. * patients who are on continuous supplemental oxygen. * patients currently undergoing active treatment for other malignancies. * subjects who are unable or unwilling to provide consent.
eap of apitegromab for patients with spinal muscular atrophy

Conditions: SMA

Summary: the purpose of this expanded access program (eap) is to provide access to apitegromab for eligible patients with spinal muscular atrophy (sma) prior to approval by the local regulatory agency . a medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.


Eligibility criteria:
inclusion criteria: 1. ≥2 years of age. 2. documented diagnosis of 5q sma. exclusion criteria: 1. previous history of a hypersensitivity reaction to a monoclonal antibody or recombinant protein bearing an fc domain (eg, a soluble receptor-fc fusion protein), apitegromab, or excipients of apitegromab. 2. enrolled in a clinical study for any investigational drug. 3. pregnant or breastfeeding.

Keywords: expanded access pre-approval access compassionate use
a study of why people with early memory problems fall or almost fall

Conditions: Dementia; Falls; Near-Falls

Summary: the purpose of this study is to identify the factors that are associated with falls and near falls in community-dwelling older adults with early-stage dementia.

the specific objectives of this six month study are to: characterize falls and near-falls in community dwelling older adults with early-stage dementia; determine which potentially modifiable physical fall risk factors contribute to falls and near-falls in older adults with early-stage dementia; examine the relationship between dementia sub-type, medical and neuropsychological factors, balance and gait, and falls and near-falls in community dwelling older adults with early-stage dementia.

Eligibility criteria:
inclusion criteria: * males or females over the age of 50 with early-stage dementia as described by global deterioration scale levels 2,3,4 or 5. exclusion criteria: * subjects who have a medical condition that significantly predispose them to falls (meneire's disease or parkinson's disease) * subjects without a caregiver/spouse to assist with the completion of a fall diary * subjects unable to stand independently or safely walk a short distance either unaided or with the support of an assistive device * subjects unable to safely complete the balance and gait evaluations.

Keywords: dementia falls risk factors
prospective observational study to validate circulating hpvdna and prognostic genomic biomarkers in hpv-associated opscc

Conditions: Oropharyngeal Squamous Cell Carcinoma; Carcinoma, Squamous Cell; Head and Neck Squamous Cell Carcinoma; Oropharynx Squamous Cell Carcinoma

Summary: the primary goal of this study is to examine whether recurrence of hpv-associated opscc can be predicted by two factors: 1) mutations in genes called traf3 and cyld, and 2) measurements of circulating hpv dna in blood plasma. the study will also investigate whether hpv integration is associated with traf3 and cyld mutations, and whether recurrence prediction improves when looking at hpv integration along with traf3 and cyld mutations.


Eligibility criteria:
inclusion criteria: * ≥ 18 years of age * t0-t2 n2a-n3 m0 or t3-t4 n0-n3 m0 (ajcc 7th edition) * biopsy proven squamous cell carcinoma of the oropharynx or unknown primary * no prior therapy * no evidence of distant metastatic disease * p16 positive = diffuse ≥ 70% tumor cell expression, with at least moderate (2/3+) staining intensity * planned for receipt of definitive cancer treatment * ecog performance status 0-1 * patients must be deemed able to comply with the treatment plan and follow-up schedule. * patients must provide study specific informed consent prior to study entry exclusion criteria: all subjects meeting any of the exclusion criteria at baseline will be excluded from study participation: * prior history of radiation therapy to the head and neck * prior history of head and neck cancer. * inadequate pre-treatment tissue sample for tumor genomic analyses

Keywords: human papillomavirus hpv p16 oropharynx opscc
observational study of wearable health monitoring device

Conditions: Weight Loss

Summary: the purpose of this study is to better understand the use of healthdot devices on bariatric patients in the usa. healthdot is a wearable monitoring device that can collect data on heart rate, respiration rate, posture, and activity. this device can be worn at the hospital and at home. the healthdot will be able to send data and have good connectivity in a place where there is network coverage(4g/5g).

this clinical study is a single-center observational feasibility study of the healthdot device, a wearable health monitoring device applied to bariatric surgery/endoscopy patients for in-hospital and at-home data collection of heart rate, respiration rate, posture, and activity. after surgery, 30 bariatric patients will be applied with the healthdot device. patient data will be collected for a total of 10 days to evaluate the feasibility of the use of the healthdot device at mayo clinic and at home. patient data will only be observed retrospectively, so after the data collection period of 10 days has been concluded, the clinical care will not be affected by this. feasibility includes the connectivity performance, the usability from a hospital staff perspective with a focus on staff satisfaction and potential interference with hospital workflow, and the usability from a patient perspective with a focus on patient satisfaction and potential interference with normal daily activities. the collected information will be processed to establish the feasibility of a larger interventional clinical trial using healthdot in bariatric patients.

Eligibility criteria:
inclusion criteria: * patients being seen for upcoming planned weight-loss procedure (esg, balloon, bariatric surgery, revision after bariatric surgery). * commitment to wear device without removing for entire study period. * located within a driving distance from mayo clinic in rochester, minnesota during study duration. * reside in an area with 4g or 5g connectivity based on cellphone provider maps for t-mobile or at\&t. * subject clear of any dermatologic health diagnosis that may impede the ability of the device to adhere properly. exclusion criteria: * unable to give consent. * unwillingness to utilize email address for device instructions, surveys, and reminders. * lifestyle that would have the device exposed to excessive elements for a prolonged period of time outside the parameters of normal operation of the device. * patient is expected/anticipated to fly (use an airplane) before study completion (before day 10). * subjects with a pacemaker or an implanted electronic device. * subjects scheduled or likely to conduct mri within the study period. * left lower rib (place where healthdot will be applied) is involved in the area of surgery, area of disinfection or area where bandages are needed. * patients with severe systemic diseases.
phase 1 dose escalation study for vip236 in patients with advanced cancer

Conditions: Neoplasms

Summary: determine the safety, tolerability, and maximum tolerated dose (mtd) of iv administered vip236 as monotherapy in patients with advanced solid tumor cancer

solid tumor subjects with histologically confirmed advanced or metastatic disease who have relapsed or refractory to standard of care. subjects must have exhausted all available standard therapies or be deemed ineligible for potential available therapies.

Eligibility criteria:
inclusion criteria: * adult patients aged \>/=18 years, able to provide informed consent and willing to comply with all study procedures. * histologically confirmed advanced or metastatic solid tumors that are relapsed or refractory to standard of care. subjects must have exhausted all available standard therapies or be deemed ineligible for potential available therapies. refer to nccn guidelines of each respective histology for guidance. starting with amendment 3, this study will focus enrollment on the following cancers: biliary tract cancers breast cancer cervical cancer endometrial carcinoma gastric cancer/gastroesophageal junction adenocarcinoma nonsmall cell lung cancer ovarian cancer/fallopian tube cancer/primary peritoneal cancer pancreatic adenocarcinoma small cell lung cancer urothelial cancer * adequate bone marrow, liver, and renal functions. * eastern cooperative oncology group (ecog) performance status of 0 to 2. exclusion criteria: * subjects who have new or progressive brain or meningeal or spinal metastases. * clinically significant cardiac disease including congestive heart failure \> new york heart association (nyha) class ii), evidence for coronary artery disease (eg, unstable angina (anginal symptoms at rest) or new-onset angina (within the last 6 months or myocardial infarction within the past 6 months before first dose. * major surgery or significant trauma within 4 weeks before the first dose of study drug. * medical history of chronic obstructive pulmonary disease (copd) and other respiratory disorders.

Keywords: vip236 solid tumors biliary tract cancer breast cancer small cell lung cancer triple negative breast cancer cervical cancer gastric cancer lung cancer non-small cell lung cancer ovarian cancer pancreatic adenocarcinoma advanced solid tumors metastatic cancer endometrial cancer urothelial cancer
study evaluating intravitreal hi-con1™ in patients with choroidal neovascularization secondary to age-related macular degeneration

Conditions: Choroidal Neovascularization; Age-related Macular Degeneration

Summary: the purpose of this study is to evaluate the safety, biological activity and pharmacodynamic effect of repeated intravitreal doses of hi-con1 0.3 mg administered as monotherapy and in combination with ranibizumab 0.5 mg compared to ranibizumab 0.5 mg monotherapy in treating patients with choroidal neovascularization (cnv) secondary to age-related macular degeneration (amd).


Eligibility criteria:
inclusion criteria: * males or females of any race at least 50 years of age * active primary choroidal neovascularization (cnv) secondary to age-related macular degeneration (amd) in the study eye * best corrected visual acuity (bcva) of 70 to 24 letters (worse than 20/40 up to 20/320) in the study eye exclusion criteria: * monocular patient or patient with a bcva of 35 or fewer letters (20/200 or worse) in the better seeing eye * any prior treatment of cnv or advanced amd in the study eye, except for dietary supplements or vitamins * any intraocular or ocular surface surgery (including cataract surgery and laser procedures) in the study eye within 3 months * vitrectomy in the study eye * hereditary or chronic hemorrhagic or coagulopathy conditions (i.e., hemophilia)
a trial in patients with advanced cancer and leukemia

Conditions: Neoplasms by Histologic Type

Summary: this is a phase 1, dose escalating study to determine the safety of pf-03084014 in patients with advanced cancer and leukemia


Eligibility criteria:
inclusion criteria: * patients with advanced cancer that is resistant to standard therapy or for which no standard therapy is available * patients with acute t cell leukemia/lymphoblastic lymphoma that is resistant to standard therapy or for which no standard therapy is available * men and women \>16 years old exclusion criteria: * prior treatment with a gamma secretase inhibitor for treatment of cancer * patients taking tamoxifen * patients with active graft versus host disease * known human immunodeficiency virus (hiv) or acquired immunodeficiency syndrome (aids) related illness * patients who are pregnant or breast feeding * patients with clinical evidence of central nervous system disease

Keywords: phase 1 dose escalation study in advanced solid tumor malignancy and leukemia
modulation of h-reflex after application of electric currents in healthy people

Conditions: Spasticity

Summary: the purpose of this study is to determinate whether the application of electric currents produce changes in the excitability of alpha moto neurone. moreover evidence whether the effect of the electric currents can change the tone of the muscle under stimulation in healthy volunteers

in the last years several experimental studies have evidenced that the transcutaneous electric nerve stimulation (tens) in peripheric application can cause a decrease of spasticity and modulation of h-reflexes. but if the application is in the central nervous system the results are different. so the purpose of this study is quantify the modulation of the excitability of alpha moto neurone when the application of the current is in the central nervous system compared with a sham group.

Eligibility criteria:
inclusion criteria: * participants will be volunteer healthy students of physiotherapy, university of castilla - la mancha, older than 18 years. exclusion criteria: * neuromuscular disease * epilepsy * trauma, surgery or pain affecting the upper limb, shoulder girdle or cervical area * osteosynthesis material in the upper limb * diabetes * cancer * cardiovascular disease * pacemaker or other implanted electrical device * take any drug (nsaids, corticosteroids, antidepressants, analgesics, antiepileptics, ...) during the study and in the previous 7 days. * presence of tattoos or other external agent introduced into the treatment or assessment area. * pregnancy * sensitivity disturbance in lower limb

Keywords: h-reflex tens tone
study of the psychometric properties and a measure of utility determinants ( the sf- 6d) in patients with early inflammatory low back pain

Conditions: Spondylarthritis

Summary: the general main objective of our study is to investigate the psychometric properties, the levels and determinants of the extent of sf- 6d utility in patients followed for recent back pain inflammatory disease. the specific objectives are : * study the feasibility of the tool considering missing data, distribution, construct validity, reproducibility, sensitivity to change or clinically different groups (discriminative ability) the extent of sf -6d utility . * study the impact of socio-demographic characteristics, disease characteristics and quality of life, comorbidities at baseline on the measurement of utility and sensitivity to change.


Eligibility criteria:
inclusion criteria: * the patient should be given free and informed consent and signed the consent * the patient must be affiliated or beneficiary of a health insurance plan * patients aged 18 years and under 50 * inflammatory back pain (buttocks , lumbar or thoracic spine ) * fulfilling the criteria of calin or berlin (30,31) * duration of symptoms than three months and less than three years * symptoms suggestive of spondyloarthritis as assessed by the local investigator ( score≥5 on a numerical scale from 0 to 10 where 0 = no evocative and 10 = very suggestive of spondyloarthritis ) . exclusion criteria: * another clearly defined spinal disease (eg discarthrose ) * history of treatment with biotherapy * taking glucocorticoids allowed only in low dose of less than 10mg of prednisone daily and stable for at least four weeks before inclusion * current or history anomalies that could interfere with the validity of informed consent and / or prevent a patient's optimal adhesion to the cohort (eg , alcoholism , mental illness) .
lung dispersing, turbid descending and gut clearing decoction for bronchiectasis

Conditions: Bronchiectasis Adult; Traditional Chinese Medicine; Quality of Life; Exacerbation

Summary: bronchiectasis is a chronic airway disease which confers significant healthcare burden, with limited therapeutic approaches. from the perspective of traditional chinese medicine, congenital insufficiency of the lung, spleen and kidney, when coupled with external injury or mood impairment, may collectively contribute to bronchiectasis pathogenesis due to heat trapping in the phlems, congestion of wind evils and stagnation of blood. here, the investigators will explore the lung dispersing, turbid descending and gut clearing decoction (ltgd) which targets at expelling the wind evil in patients with bronchiectasis. the investigators sought to conduct a multicenter, randomized cross-over trial which investigates the efficacy and safety of ltgd on clinically stable bronchiectasis.

bronchiectasis is a chronic airway disease which confers significant healthcare burden, with limited therapeutic approaches. from the perspective of traditional chinese medicine, congenital insufficiency of the lung, spleen and kidney, when coupled with external injury or mood impairment, may collectively contribute to bronchiectasis pathogenesis due to heat trapping in the phlems, congestion of wind evils and stagnation of blood. symptomatic treatment may be effective and safe for ameliorating respiratory symptoms and hindering disease progression of bronchiectasis. here, the investigators have explored the lung dispersing, turbid descending and gut clearing decoction (ltgd) which targets at expelling the wind evil in patients with bronchiectasis. the investigators sought to conduct a multicenter, randomized cross-over trial which investigates the efficacy and safety of ltgd on clinically stable bronchiectasis.

Eligibility criteria:
inclusion criteria: * aged between 18 and 75 years; * remained clinically stable (respiratory symptoms and lung function parameters not exceeding normal daily variations) for 4 consecutive weeks; * no acute upper respiratory tract infections within 4 weeks; * 1 or more bes within the previous 2 years exclusion criteria: * other unstable concomitant systemic illnesses (i.e. coronary heart disease, recent cerebral stroke, severe uncontrolled hypertension, active gastric or duodenal ulcer, uncontrolled diabetes, malignancy, hepatic or renal dysfunction); * concomitant asthma, allergic bronchopulmonary aspergillosis, or active tuberculosis; * concomitant chronic obstructive pulmonary disease as the predominant diagnosis; * treatment with inhaled, oral or systemic antibiotics within 4 weeks; * type 2 respiratory failure needing oxygen therapy or non-invasive mechanical ventilation; * females during lactation or pregnancy; * poor understanding or failure to properly operate the instrument; * participation in other clinical trials within 3 months.
relationship between attention and emotional regulation post-traumatic brain injury (tbi)

Conditions: Traumatic Brain Injury

Summary: the purpose of this pilot study is to investigate the relationship between attention and emotional function post-traumatic brain injury (tbi) in an effort to better understand the cognitive mechanisms of emotional processing in patients with tbi, and explore novel treatment strategies to improve emotional regulation using with transcranial direct current stimulation (tdcs) to modulate activity in the dysfunctional prefrontal-limbic circuits.

thirty (30) individuals status post tbi with complaints of emotional dysfunction 6 months post-brain injury and fifteen (15) healthy controls will participate in the study. the experimental group will receive active tdcs for 20 minutes and computerized cognitive training twice a week for 30-45 minutes for 6 weeks as described below. the control group will receive sham-tdcs 20 minutes and computerized cognitive training for 30-45 minutes twice a week for 6 weeks (12 training sessions). the sham group will not receive real tdcs after completion of the study.

Eligibility criteria:
inclusion criteria: * brain injury at least 6 months prior * family or self-identification of cognitive or emotional difficulties * unchanged and stabilized medical treatment in the three weeks prior to the screening exclusion criteria: * any social or medical problem that precludes completion of the protocol. * presence of focal motor deficits in the upper extremities. * comorbid psychiatric disease such as schizophrenia, or active substance abusers (except nicotine). * history of craniectomy, active infection, or seizure activity beyond 1 week post-tbi. * complicating medical problems such as uncontrolled hypertension, diabetes with signs of neuropathy, and previous neurological illness such as head trauma, prior stroke, epilepsy or demyelinating disease, implanted neuromodulatory or electronic device, metal in head * pregnancy

Keywords: tbi traumatic brain injury rehabilitation therapy