Kornimate/medical-research-clean huggingface dataset:
the effects of supplementing tyrosine on blood pressure in parkinson's disease

Conditions: Parkinson's Disease

Summary: the objective of this experiment is: * primary: to determine the effects of tyrosine supplementation on orthostatic hypotension in people with pd. * secondary: to determine the effects of tyrosine supplementation in people with pd with autonomic insufficiency on hr, bp, and norepinephrine responses during acute exercise stress. orthostatic hypotension and autonomic abnormalities are a common problem for individuals who suffer from pd, especially as it leads to lightheadedness and falling. for those affected, it can drastically reduce quality of life. it has been hypothesized that tyrosine may impact upon individuals suffering from pd. there is ample evidence in animal models that supports our theory; however there is no clinical evidence of the impact tyrosine supplementation may have in pd patients who suffer from orthostatic hypotension and blunted bp and hr responses. positive findings that supplemental tyrosine increases bp and hr in people with pd during daily activities such as standing up from a chair and walking can lead to new therapies to improve parkinsonian orthostatic hypotension. hypothesis we will test the hypothesis that symptomatic individuals with pd on dopamine therapy who suffer from orthostatic hypotension and blunted hr and bp responses will improve after tyrosine supplementation.


Eligibility criteria:
inclusion criteria: * diagnosis of pd according to the uk brain bank diagnostic criteria * diagnosis of orthostatic hypotension according to efns guidelines * able to walk on a treadmill comfortably for 6-10 minutes * currently taking levodopa * subjects between the age of 50-80 years old exclusion criteria: * currently taking an amino acid supplement * currently taking medication that affects bp * normal bp response to testing

Keywords: parkinson's disease (pd) orthostatic hypotension (oh)
virtual exercise for older adults with mild cognitive impairment

Conditions: Mild Cognitive Impairment

Summary: this project is designed to develop and evaluate an internet-based exercise intervention (tai ji quan moving to improve brain health) using real-time videoconferencing for older adults with mild cognitive impairment (mci).

the project has three major goals: (a) transforming an in-person tai ji quan brain health intervention protocol into an online (virtual) class protocol and evaluating its feasibility of implementation in older adults with mci, (b) developing and evaluating online assessment and data ascertainment procedures that encompass cognitive and physical performance measures, and (c) conducting a randomized controlled trial comparing the effectiveness of this new online intervention protocol with a conventional stretching exercise group in older adults with mci.

Eligibility criteria:
inclusion criteria: * self-report a change or decline in memory (corroborated by an informant) * record a score of ≤0.5 on the clinical dementia rating (cdr) scale (with information derived from both the participant and an informant) * show no major impairment in cognitive function as indexed by a score of ≥24 on the mini mental state evaluation (mmse). exclusion criteria: * have participated in a rigorous and structured physical activity or exercise program (including tai ji quan) in the past 6 months, * show major signs of depression as indicated by a score of ≥5 on the geriatric depression scale * have major medical or physical conditions that preclude exercise, as determined by their healthcare practitioner * being unable to follow the consent process or sign the study consent form.

Keywords: tai chi, ehealth, older adults, cognitive impairment
studying protein expression in tissue samples from younger patients with rhabdomyosarcoma

Conditions: Alveolar Childhood Rhabdomyosarcoma; Embryonal Childhood Rhabdomyosarcoma; Previously Treated Childhood Rhabdomyosarcoma; Previously Untreated Childhood Rhabdomyosarcoma; Recurrent Childhood Rhabdomyosarcoma

Summary: this research trial studies protein expression in tissue samples from younger patients with rhabdomyosarcoma. studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in dna and identify biomarkers related to cancer. it may also help doctors find better ways to treat cancer.

primary objectives: i. to investigate (in two stages) which proteins are overexpressed in association with 12q13-q14 amplification by applying fluorescence in situ hybridization (fish) and immunohistochemical (ihc) assays to a panel of alveolar rhabdomyosarcomas (arms) cases organized into tissue microarrays. outline: formalin-fixed paraffin-embedded tissue samples are analyzed for 12q13-q14 frequency and protein overexpression by fish and ihc.

Eligibility criteria:
inclusion criteria: * slides of the 2006 alveolar rhabdomyosarcoma (arms) tma and the 2009 arms/anaplastic embryonal rhabdomyosarcoma (erms) tma * pax3-foxo1-positive tumors * pax7-foxo1-positive tumors * fusion-negative tumors
my01 - an aid for diagnosing acute compartment syndrome in real time

Conditions: Acute Compartment Syndrome

Summary: compartment syndrome can result from extremity trauma. it can also be caused by procedural cases that involve lower or upper extremity surgery. this condition results in muscle death, chronic pain, infection, and possible amputation. early diagnosis is essential to institute interventions that can avoid complications. subjective pain of the patient remains the mainstay for diagnosis. a method or device is needed that would improve our accuracy in diagnosing compartment syndrome. ideally, this would be suited for single and/or continuous pressure read-outs. the aim is to reduce the incidence of missed compartment syndrome and diminish delays that would lead to significant disability. despite awareness, delayed diagnosis and treatment occurs in modern orthopaedic practice. as noted in many studies, once a diagnosis has been made, immediate fasciotomy is necessary to provide the best chance for a favourable clinical result. therefore, there is a need for improved devices in order to obtain an early and reliable diagnosis.


Eligibility criteria:
inclusion criteria: * men or women, aged 18 years of age and older * any tibial, foot, femoral, forearm or fracture that is felt by the surgeon to have a reasonable indication that elevated icp could occur in the patient * mentally fit to provide informed consent exclusion criteria: * patients with fractures that are not felt to be at risk of developing compartment syndrome based on serial clinical evaluation * infected wounds; infected fractures * patients who present with acs requiring urgent surgical fasciotomy * patients who cannot consent to trial * pregnant women

Keywords: acute compartment syndrome
evaluate the clinical efficacy of whole body cryotherapy in the cryosense cabin for the treatment of fibromyalgia

Conditions: Fibromyalgia

Summary: the aim of this study is to evaluate the effectiveness of an intervention with sessions of 3 minutes of whole body cryotherapy (wbc) in the cryosense cabin. measurement period time: 8 weeks.

the aim of this study is to evaluate the effectiveness of an intervention with sessions of 3 minutes of whole body cryotherapy (wbc) in the cryosense cabin, on the main clinical manifestations of patients with fibromyalgia (fm). a randomized, open and crossed 8-week clinical trial comparing a wbc intervention with the waiting list control group. patients diagnosed with fm according to acr 2010 criteria, in treatment and regular follow-up recruited consecutively. two groups were made, one of intervention and one of waiting list which served as control during the first phase. at the end of the first phase, and after a week of washout, the groups crossed and went on to carry out the second phase following the opposite intervention. the pharmacological treatment was not modified during the entire study. trial endpoints were changed in pain after 2 and 4 weeks, measured by a visual analogue scale (vas) and burden of disease, evaluated by the fibromyalgia impact questionnaire(fiq).

Eligibility criteria:
inclusion criteria: * age between 25 and 80 years old * diagnosis of fibromyalgia according to acr criteria * more than 1 year from diagnosis * lack of response or partial response to previous treatment * in case of women,commitment not to get pregnant during the study. exclusion criteria: * patiens with cardiovascular or psychiatric comorbidity * cold intolerance * changes in pharmacological treatment during the study * body temperature over 37,5ºc

Keywords: fibromyalgia, whole body cryotherapy
baseline sleep apnea study #2

Conditions: Obstructive Sleep Apnea of Adult

Summary: this is a single group, unblinded, prospective clinical study. this study seeks to understand patient diagnostic and treatment journey and positive airway pressure (pap) therapy compliance for verily sleep apnea (vsa) program/app users. participants will enroll remotely and may undergo a home sleep test (hst). upon confirmation of obstructive sleep apnea (osa) and prescription of pap therapy, the participant will begin using the vsa app to supplement pap treatment. after 90 days of active participation, the participant will be given instructions for follow-up care, as indicated.


Eligibility criteria:
inclusion criteria: * ages 18 or older * able to speak and read english * legal united states resident with a government issued id * participating in the project baseline community study * demonstrates understanding of the study requirements and is able and willing to sign the informed consent form * own a smartphone with a data plan and be the primary user of the smartphone; smartphone must use android lollipop (5.1+/ api 22+) or ios 11.x+ * own a computer with a web camera * consistent access to electricity and wifi for the duration of the study * have a high risk of osa as determined by screening questionnaire * good candidate for pap therapy, in the opinion of the managing clinician * without significant limitation in ability to participate in the study, in the opinion of the investigator. exclusion criteria: * previously diagnosed with sleep apnea or other sleep disorders, that in the opinion of the investigator, makes the participant ineligible (e.g., obstructive sleep apnea, central sleep apnea, complex sleep apnea, chronic insomnia) * participant is a shift worker (indicated by having a night shift schedule on a regular basis, or a work shift that changes or rotates on a daily, weekly, or monthly basis) * sponsor employees and individuals working on project baseline * self reported to be pregnant or planning to become pregnant during the study period * current use of home oxygenation devices, such as supplemental oxygen
a pilot study using placenta derived decidual stromal cells for toxicity and inflammation with special focus to the allogeneic hematopoietic cell transplantation setting

Conditions: Acute Lung Injury; Decidual Stromal Cells; Stem Cell Transplantation; Inflammation

Summary: to evaluate safety and efficacy using decidual stromal cell therapy for toxicity and inflammation, with special focus on allogeneic hematopoietic cell transplantation patients. the hypothesis to be tested is that the cells are safe to infuse and that they have an anti-inflammatory and healing effect.

patients with toxicity, inflammation or hemorrhages will receive decidual stromal cells at approximately 1x10\^6 cells/kg at one or more occasions at weekly intervals dependent on clinical response.

Eligibility criteria:
inclusion criteria: * patients with toxicity, inflammation or hemorrhages. exclusion criteria: * none
safety and immunogenicity of personalized genomic vaccine and tumor treating fields (ttfields) to treat glioblastoma

Conditions: Glioblastoma

Summary: the purpose of this study is to use precision medicine in the form of a vaccine, a mutation-derived tumor antigen vaccine (mta-based vaccine) in combination with standard care treatment of glioblastoma (gbm) and tumor treating fields (ttfields). the study is designed to determine whether this treatment combination is well tolerated and safe.

this is a single-arm, single institution phase 1a / 1b study to test the safety, tolerability, and immunogenicity of mta-based personalized vaccine in patients with newly diagnosed gbm along with the use of continual ttfields. mta-based personalized vaccine is prepared in the laboratory with several peptides based on each patient's own tumor sequence. the vaccine is given after the radiation and chemotherapy portion of the treatment, in the maintenance phase of temozolomide in conjunction with the ttfields.

Eligibility criteria:
inclusion criteria: * age ≥ 18 * confirmation of gbm (who grade iv). * maximal debulking surgery and undergo radiotherapy concomitant with temozolomide (45-70gy) * stable disease after treatment of radiation with chemotherapy * life expectancy \> 16 weeks. * performance status of 0-2 (eastern cooperative oncology group). * first vaccine treatment start date at least 4 weeks out but not more than 8 weeks from the last dose of concomitant temozolomide or radiotherapy. * must have tumor tissue sufficient sequencing. * have adequate bone marrow function * require dexamethasone ≤ 4mg daily on a stable dose * acceptable hematologic, hepatic, and renal function and these tests must be performed within 14 days prior to study * the participant must be deemed competent to give informed consent. * the participant must agree to use two effective forms of contraception beginning at least four (4) weeks prior to study entry. exclusion criteria: * progression of disease at time of screening. * implanted pacemaker, programmable shunts, defibrillator, deep brain stimulator, other implanted electronic devices in the brain, or documented clinically significant arrhythmias. * infra-tentorial tumor or multifocal disease. * history of hypersensitivity reaction to temozolomide. * receiving any other investigational agents. * prior history of unrelated neoplastic disease, and having received systemic therapy for the secondary malignancy within the twelve (12) month period preceding the screening evaluation. * (hiv/aids), chronic hepatitis b or hepatitis c. * history of, or is reasonably suspected to meet criteria for the diagnosis of a known congenital or acquired disorder causing systemic immunosuppression. * history of, or is reasonably suspected to meet criteria for the diagnosis of a systemic auto-immune/inflammatory disease or other autoimmune disorder with the exception of: vitiligo * positive pregnancy test \[45 cfr 46.203(b)\]. (cfr = code of federal regulations)

Keywords: brain cancer glioblastoma personalized vaccine poly-iclc (polyinosinic-polycytidylic acid) immunotherapy cancer novottf-200a optune gbm immunogenicity
chronotropic incompetence (ci) diagnostic algorithm in heart failure patients

Conditions: Heart Failure

Summary: this study is to collect human activity and electrocardiogram (ecg) data from heart failure (hf) patients to aid in the development of a novel chronotropic incompetence (ci) algorithm designed to diagnose ci in patients with hf.

the investigation of the chronotropic incompetence diagnostic algorithm in heart failure patients (ci algorithm study) is an acute data collection study using market released actigraphy devices (wgt3x-bt) and holter devices (dr 180) to measure study subjects' daily activities and surface ecg data simultaneously. the data will be analyzed to develop an algorithm to diagnose ci in patients with hf.

Eligibility criteria:
inclusion criteria for the case group: * patient is greater than 18 years of age and less than 70 years of old. * patient is willing and able to give informed consent. * patient has been diagnosed with stable chronic hf according to european society of cardiology 2012 hf guidance. * new york heart association class i- iii, including with hf with preserved ejection fraction and hf with reduced ejection fraction patients. * patients can perform moderate exercise. * left ventricular ejection fraction less than 55% but greater than 35%. inclusion criteria for the control group: * subject is greater than 18 years of age and less than 70 years of old. * subject is willing and able to give informed consent. exclusion criteria for the case group: * patient is unable or unwilling to sign the patient informed consent. * patient has implantable pacemaker, implantable cardiovert defibrillator (icd) or cardiac resynchronize therapy (crt) device. * patient has at least one pacemaker, icd or crt indications. * patients has persistent atrial fibrillation (af). * patient whose hear rate baseline at the rest is greater than 95 beats per minutes (bpm). * patient has contraindications for cardio-pulmonary exercise testing, including but not limited to, unstable angina, decompensated heart failure, active pericarditis or myocarditis and ecg st-segment shift \> 2mm at the resting. * new york heart association class iv. * less than 45 days after myocardial infarction. * less than 3 months after acute heart failure. * patient has uncontrolled hypertension. * patient is pregnant. * patient has a medical condition that would limit study participation. * patient is enrolled in a concurrent study that may affect the outcome of this study.

Keywords: chronotropic incompetence heart failure
less to hold - a comparison of bladder toxicities (side effects) in patients undergoing prostate radiotherapy between patients treated with empty bladder and those on a drinking protocol.

Conditions: Prostate Cancer; Radiotherapy Side Effect

Summary: radical radiotherapy to the prostate is conventionally treated with a full bladder with the aim of minimising dose to the bladder and small bowel to prevent significant side effects. tolerance of the bladder filling protocol varies depending on patients' baseline urinary function. it is not uncommon for some men to have "accidents" during treatment causing understandable distress. this can also extend the treatment time and cause knock on delays in the radiotherapy department. several united kingdom (uk) centres report treating with an empty bladder. the investigators carried out a feasibility study comparing treatment with full bladder to empty bladder to ascertain if the investigators can safely change our protocol to that of an empty bladder.

50 patients receiving radical radiotherapy to the prostate were randomised using closed envelope technique 1:1 into 2 groups. group a followed the conventional drinking protocol at our centre (200ml prior to treatment) and group b were treated with an empty bladder. baseline, end of treatment and 6 week follow up scores were prospectively collected for international prostate symptom score(ipss), late effects normal tissue task force - subjective, objective, management, analytic (lent soma) bowel toxicity and quality of life questionnaires. the investigators also looked at bowel and bladder dose volume histogram (dvh) to ensure constraints were met.

Eligibility criteria:
inclusion criteria: * prostate cancer receiving radical radiotherapy. exclusion criteria: * not nodal disease. * not prostate bed radiotherapy.
a phase iia study with escalating dose of ms1819-sd

Conditions: Chronic Pancreatitis; Distal Pancreatectomy

Summary: this is a phase iia study sponsored by azurrx sas and syneos health is a local representative sponsor and involves testing of a new medication for the compensation of exocrine pancreatic insufficiency (epi) caused by chronic pacreatitis (cp) and/or distal pancreatectomy. the new medication is called ms1819 spray dried (ms1819-sd) which is a lipase produced by the lip2 gene of yarrowia lipolytica using recombinant dna technology. the primary purpose of this study is to investigate the safety of escalating doses of study drug ms1819-sd in people with chronic pancreatitis. this enzyme has demonstrated an appropriate profile to compensate the pancreatic lipase (enzyme) deficiency that is common with cp patients. the deficiency in this enzyme can be responsible of greasy diarrhea, fecal urge and weight loss. the design of the study is open-label, meaning that all eligible participants will receive the study drug ms1819-sd. the ms1819-sd dose will increase throughout the study during dose escalation visits in each treatment period; study includes a total of four treatment periods. the total duration of the ms1819-sd treatment phase is of 48-60 days, the total duration of patient participation in the study is of 74-93 days. approximately twelve patients will be enrolled in this study.


Eligibility criteria:
inclusion criteria: 1. signed and dated informed consent form, 2. age \>18 years, 3. male or female, 4. body weight within the range \[50-100 kg\] for males or \[40-90 kg\] for females, 5. distal pancreatectomy for any disorder (e.g. acute pancreatitis or its complications, cp or its complications, pancreatic endocrine or exocrine cancer, or others) and/or cp of any etiology (e.g. alcohol, genetics, hypercalcemia, or others) of grade 2 or higher (cambridge classification), 6. faecal pancreatic elastase-1 \<100 μg/g of stools at screening or within one month of the screening visit, 7. cfa measurement ≤ 75% at washout 8. female patients must be post-menopausal (defined as at least 12 months post cessation of menses), surgically sterile or, if of childbearing potential, using a reliable method of contraception during the study. 9. being considered as reliable and capable of adhering to the protocol, according to the judgment of the investigator. exclusion criteria: 1. cystic fibrosis, 2. total or partial gastrectomy, 3. cephalic or total duodenopancreatectomy, 4. documented fibrosing colonopathy, 5. any small bowel disease possibly responsible for malabsorption, including small intestinal bacterial overgrowth, celiac disease, small bowel resection ≥1 meter length, etc., 6. acute pancreatitis or exacerbation of cp ≤3 months, 7. pancreatectomy for exocrine or endocrine cancer ≤1 year, 8. metastatic or locally recurrent exocrine pancreatic cancer, 9. known hypersensitivity or other severe reaction to any ingredient of the investigational medicinal product, 10. bilirubin \>3 times uln (upper limit normal),

Keywords: exocrine pancreatic insufficiency