Kornimate/medical-research-clean huggingface dataset:
vibrotactile stimulation in parkinson's disease

Conditions: Parkinson's Disease

Summary: the purpose of this study is to examine the possibility of a new, non-invasive, non-drug treatment for parkinson's disease. the treatment involves gentle vibratory stimulation delivered to the fingertips (called 'vibrotactile stimulation'). along with the treatment, participants will also undergo kinematic testing.

patient will be phone screened and/or have a physical and neurological examination to determine if it is appropriate for them to participate in this study. this testing includes the unified parkinson's disease rating scale, part iii (updrs iii). research assistants will explain the study and obtain informed consent. there will be three consecutive days of testing, as well as 2 follow up visits at 1 and 4 weeks. visits include the following: patients will have sensors put on their hands, feet, and chest. these sensors measure their movement while they perform kinematic tasks such as forward walking, wrist movements, and the updrs iii. patients will also be given vibrotactile stimulation for a total of 4 hours throughout the day. during this time, patients will be provided with books/movies as entertainment, and they may move around freely. patients will also be asked to complete several questionnaires throughout the visits about their parkinson's symptoms.

Eligibility criteria:
inclusion criteria: 1. age at least 18 years of age. 2. speaks and understands english. 3. a diagnosis of idiopathic parkinson's disease, hoehn and yahr stage ii or iii 4. able and willing to come to study visits (3 consecutive days, as well as 2 follow up visits, at 1 and 4 weeks) 5. able and willing to stop therapy during the daytime for the days they come to the clinic for the study. 6. have improvement in motor signs on versus off dopaminergic medication. 7. if on medication, the patient should be on stable doses of sinemet and/or stalevo (carbidopa/levodopa parkinson's medication) as part of their medicinal regimen (patient does not need to be on medication to be included in the study). exclusion criteria: 1. subjects, who are pregnant, are capable of becoming pregnant, or who are breast feeding. 2. subjects with very advanced parkinson's disease, hoehn and yahr stage iv on medication (non-ambulatory). 3. have significant cognitive impairment and/or dementia, as determined by a neurologist at the stanford movement disorders clinic. 4. have an implanted electronic device such as a cardiac pacemaker/defibrillator or medication pump. 5. subjects who have an inability to comply with study follow-up visits. 6. subjects who are unable to understand or sign the informed consent. 7. have an mri showing focal brain lesions that could indicate a non-idiopathic movement disorder. 8. have an active infection. 9. require diathermy, electroconvulsive therapy (ect), or transcranial magnetic stimulation (tms) to treat a chronic condition.
efficacy and safety of an h.pylori vaccine in h.pylori-negative adults

Conditions: Helicobacter Pylori Infection

Summary: to study the safety, immunogenicity and efficacy of an investigational h. pylori vaccine, compared with placebo.


Eligibility criteria:
inclusion criteria: * adults 18 - 40 years of age in good health * hp uninfected * not pregnant and agree to use birth control throughout the study (females who can become pregnant) exclusion criteria: * remote or current hp infection

Keywords: helicobacter pylori infection vaccination adults
the use of transcranial focused ultrasound for the treatment of neurodegenerative dementias

Conditions: Mild Cognitive Impairment; Mild Dementia; Parkinson Disease; Alzheimer Disease

Summary: the purpose of this open label study is to evaluate longer term tolerability and early efficacy of transcranial ultrasound in the treatment of patients with mild cognitive impairment or dementia.

the present study is designed as an open label study of patients with mild cognitive impairment (mci) or dementia to evaluate longer term tolerability and early efficacy of transcranial ultrasound treatment. baseline and outcome measures in this study utilize validated tests that are appropriate for repeated measures which are not affected by practice effects. for patients with amnestic predominant cognitive change, the target will be the mesial temporal lobe through a trans temporal scalp window. targeting will include reference to scalp fiducials based on the obtained mri and transcranial doppler (tcd) waveform confirmation will be obtained because of the ability of tcd to record doppler signal from the posterior cerebral artery that runs medial to the mesial temporal lobe. on the day of the ultrasound appointment, patients will undergo ten to thirty minutes of transcranial ultrasound treatment. the sonification device will be aimed at the hippocampus or the putamen and substantia nigra, depending on the predetermined condition. targeting will include reference to scalp fiducials based on the obtained mri; confirmation of target accuracy will either be obtained by doppler waveform confirmation or optical tracking technology which co-registers patient neuroimaging with real space. patients will undergo 8 total sessions of focused ultrasound. patients will be evaluated at baseline and upon final ultrasound treatment using the same measures obtained upon entry. safety and any adverse events will be monitored closely.

Eligibility criteria:
inclusion criteria: * cdr stage of at least 0.5 (mild cognitive impairment) * at least one pathognomic imaging biomarker of a neurodegenerative process. exclusion criteria: * cognitive decline clearly related to an acute illness * subjects unable to give informed consent * subjects with scalp rash or open wounds on the scalp (for example from treatment of squamous cell cancer) * advanced terminal illness * advanced kidney, pulmonary, cardiac or liver failure * subjects who would not be able to lay down without excessive movement in a calm environment sufficiently long enough to be able to achieve sleep * subjects with major depressive disorder * subjects with vascular causes of dementia
effect of albumin-bound paclitaxel plus carboplatin compared with paclitaxel plus carboplatin in patients receiving neoadjuvant chemotherapy for advanced ovarian, fallopian tube or peritoneal cancer: a phase 2 single center clinical trial

Conditions: Ovarian Cancer

Summary: neoadjuvant chemotherapy (nact) is an important option for patients with advanced ovarian cancer. paclitaxel plus carboplatin is the first-line regimen for ovarian cancer nact patients. however, the efficacy of nact is controversial, how to improve the efficacy become an urgent problem to be solved in the treatment of ovarian cancer. it has been confirmed that the dose-intensive paclitaxel combined carboplatin regimen can improve the prognosis in asian patients with advanced ovarian cancer. however, this protocol has a low rate of complete tumor remission after nact (4%) with toxicities and high probability of severe hypersensitivity reactions. albumin-bound paclitaxel has the characteristics of tumor targeting, low allergenicity. we propose that dose-dense albumin-bound paclitaxel (ddnab-paclitaxel) (100 mg/m2, days 1, 8, and 15) combined with carboplatin (auc = 5 days 1, 4 weeks) regimen may be superior to the paclitaxel plus carboplatin regimen. we conducted this phase ii randomized controlled study to testify the efficacy of dd-nab paclitaxel. 57 stage iiic-iv patients with high-grade epithelial, fallopian tube, and peritoneal cancer who are unable to undergo optimal cytoreduction and receive nact after tumor biopsy will be recruited. the regimen for the study group is albumin-bound paclitaxel (100 mg/m2, days 1, 8, and 15 doses) combined with carboplatin (auc = 5 day 1, 4 weeks), while patients in the control group use paclitaxel (175 mg/m2, day 1) combined with carboplatin (auc=6, day1). interval debulking surgery(ids) will be performed within 3-4 weeks after 3 cycles of nact. the primary endpoint is the proportion of chemotherapy response score (crs) of 3 according to the crs system. the secondary endpoints are progression-free survival(pfs), overall survival(os) and the rates of complete resection and adverse events(aes).


Eligibility criteria:
inclusion criteria: * international federation of gynecology and obstetrics(figo) stage iiic-iva, hgsoc patients with fagotti score ≥8 * adequate kidney function (blood creatinine 58-96 µmol/l) * adequate haematological function (haemoglobin ≥110g/l, leucocytes ≥4.0×109/l, neutrophils ≥2.0×109/l, platelets≥100×109/l) * adequate liver function (serum total bilirubin 3.4-22.2µmol/l, alanine aminotransferase (alt) 7-40u/l, aspartate aminotransferase (ast) 13-35u/l, ast/alt ≤1.5) * world health organization(who) score 0-2 * expected lifespan\>12 weeks exclusion criteria: * patients who had received chemotherapy, radiotherapy or any kind of targeted therapy * complicated with any other known malignancies * patients with poor cardiopulmonary function, which would limit compliance with study requirements
evaluate the efficacy, safety and tolerability of a non-hormonal intravaginal gel in postmenopausal women with symptoms of vaginal dryness.

Conditions: Vaginal Atrophy

Summary: primary: evaluation of improved vaginal moisture in postmenopausal women. secondary: the improvement of symptoms resulting from the dryness rating (vhi), evaluation of the decrease in vaginal ph, assessment of sexual function index female (fsfi), evaluation of adherence to study treatment by patient diary, assessing the acceptability of the product and subjective assessment of the patient as the itching and stinging / burning, beyond the safety assessment.

endpoint: * primary: evaluation of improved vaginal moisture in post menopausal women through vaginal health index (vhi); * secondaryevaluate the increase in fluid volume, vaginal elasticity and integrity of the epithelium by the vhi, evaluate the ph control, improvement of female sexual quality by applying the sexual function index female (fsfi), evaluate through the patient's daily treatment adherence, evaluate the acceptability (welfare, run-off and satisfaction) of the product and the improvement of itching and stinging / burning through questionnaires and verify the tolerability and safety by identifying adverse events. study desing: phase iv study, longitudinal, prospective, open label, non-comparative population: forty-six (46) post menopausal women with vaginal dryness drug: polimers and sodium lactate treatment: only treatment - two weekly applications (monday and thursday or tuesday and friday) for 12 weeks evaluation: the evaluation of the effectiveness will be held on all visits by medical clinical evaluation, evaluation of symptoms resulting from the dryness (vhi), ph evaluation (ph tape) and evaluation of female sexual quality (fsfi) and subjective evaluation as well as the compliance through the patient diary. the evaluation of the acceptability of the product will be the last visit by a questionnaire. the safety assessment will be carried out on all visits by identifying adverse events

Eligibility criteria:
inclusion criteria: * women over the age of 40 years. * in healthy postmenopausal women (not menstruating for more than one year). * women with vaginal dryness (vhi score in item vaginal moisture between 1-3) * women with active sex lives of at least one sexual intercourse in the month * women without a history of sensitivity to similar formulations. * understanding and signing an informed consent agreement. exclusion criteria: * women in using other intravaginal gel moisturizer. * women diagnosed with cancer. * women with disease or condition that, in the opinion of the gynecologist, could affect the test results. * women using hormone replacement therapy in the last 3 months. * absence of history or visible evidence of chronic skin disease or regional infections. * women with genital herpes, vaginal infections or urinary tract infection. * pregnant women and nursing mothers. * personal history of allergy and hypersensitivity to any product of feminine hygiene.
safety and efficacy of empagliflozin in gsd1b patients with neutropenia

Conditions: Glucose 6 Phosphatase Deficiency

Summary: treatment of neutropenia of glycogenosis type 1b patients with empagliflozin

symptoms of glycogen storage disease type ib (gsd ib) include - among others - hypoglycemia, hepatomegaly and neutropenia with concomitant neutrophil dysfunction, which results in recurrent bacterial and fungal infections, and inflammatory bowel disease. at present filgrastim is the only available drug to treat neutropenia in gsd ib patients; it stimulates neutrophil production, but doesn't restore their function. part of gsd ib patients doesn't respond to filgrastim treatment. the latest research results showed, that neutropenia and neutrophil dysfunction in gsd ib patients are results of extensive accumulation of 1,5-anhydroglucitol-phosphate. empagliflozin, a sglt2 inhibitor, inhibits renal glucose and 1,5-anhydroglucitol reabsorption and is an effective and safe method of treatment of neutropenia in this group of patients. empagliflozin (jardiance®) is a drug, which is registered in poland to treat type ii diabetes in adults. the aim of our study is to evaluate the efficacy and safety of neutropenia in patients with gsd ib with empagliflozin (jardiance®).

Eligibility criteria:
inclusion criteria: * minimum age 4 weeks old female or male * gsd1b confirmed by genetic analysis with neutropenia and/or reduced respiratory burst * informed consent signed by the parents/assigns, and the recipient (\>13 years old) exclusion criteria: * risk of non-compliance * chronic renal diseases (egfr \< 60 ml/min/1,73 m2) * active urinary tract infection (temporal criterion, up to recovery) * participation in another clinical trial (minimum 6 months from the end of participation until the date of signing the informed consent form) * participation in therapeutic experiment, in addition to the experimental treatment with empagliflozin (minimum 12 months from the end of participation until the date of signing the informed consent form) * pregnancy, breastfeeding * allergy to empagliflozin * lack of informed consent
evaluation of dysphagia in patients diagnosed with parkinson's disease by ultrasound

Conditions: Parkinson Disease

Summary: the primary aim of this study is to perform an ultrasonographic swallowing assessment in parkinson's patients and healthy volunteers and compare the findings with those from clinical swallowing evaluations. the secondary aim is to examine the relationship between dysphagia and functional status.

thirty patients aged 40-80 years, diagnosed with idiopathic parkinson's disease (modified hoehn-yahr stage 1-3), and thirty healthy volunteers who either applied to the physical therapy and rehabilitation outpatient clinic or received inpatient rehabilitation at beylikdüzü state hospital and istanbul physical medicine and rehabilitation training and research hospital will be included in this study. at the start of the study, sociodemographic data of both patients and volunteers will be recorded. the mini-mental test and the movement disorder society unified parkinson's disease rating scale (mds-updrs) will be used to evaluate the mental and functional status of the patients diagnosed with parkinson's disease. after the clinical dysphagia evaluation, the eat-10 questionnaire will be administered to the participants. following this, an ultrasonographic swallowing assessment will be performed on the participants. the ultrasonographic measurements will include tongue thickness (cm), resting distance between the mandible and hyoid (cm), shortest distance between the mandible and hyoid (cm), hyoid displacement (cm), hyoid displacement percentage, tongue thickness (cm) (with 5ml of water), resting distance between the mandible and hyoid (cm) (with 5ml of water), shortest distance between the mandible and hyoid (cm) (with 5ml of water), hyoid displacement (cm) (with 5ml of water), and hyoid displacement percentage (%) (with 5ml of water).

Eligibility criteria:
inclusion criteria: * diagnosis of idiopathic parkinson's disease by a neurologist. * being in stages 1-3 according to the modified hoehn-yahr staging scale. * scoring at least 24 on the mini-mental state examination (mmse). * not having received any therapy or treatment affecting swallowing, other than routine medication for parkinson's disease. exclusion criteria: * presence of head or neck cancer that could cause dysphagia. * history of radiotherapy or surgery in the head and neck region. * diagnosis of vascular parkinsonism or stroke. * presence of cardiopulmonary disease that could affect swallowing or breathing. * having received voice or swallowing therapy in the last 6 months. * presence of a diagnosed psychiatric disorder.
evaluation of the picosure 755nm alexandrite laser with lens array for the treatment of acne scars

Conditions: Acne Scars

Summary: the purpose of this study is to assess treatment of facial acne scars using the 755nm alexandrite laser with lens arrays.


Eligibility criteria:
inclusion criteria: 1. is a healthy male or female between 18 and 65 years old 2. has unwanted acne scars, excluding ice pick scars (deep atrophic scars that resemble poked holes), and wishes to undergo laser treatments. 3. is willing to consent to participate in the study. 4. is willing to comply with all requirements of the study including biopsies, being photographed, following post treatment care and attending all treatment and follow up visits. exclusion criteria: 1. the subject is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period. 2. the subject is hypersensitive to light exposure or takes photo sensitized medication. 3. the subject has active or localized systemic infections. 4. the subject has a coagulation disorder or is currently using anti-coagulation medication (including but not limited to heavy aspirin therapy {greater than 81 mg per day}). 5. the subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study. 6. the subject is currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within 3 months prior to entering this study. 7. the subject has used accutane within 6 months prior to enrollment. 8. the subject has the need to be exposed to artificial tanning devices or excessive sunlight during the trial. 9. the subject has had prior treatment with parenteral gold therapy (gold sodium thiomalate). 10. the subject has a history of keloids. 11. the subject has evidence of compromised wound healing. 12. the subject has a history of squamous cell carcinoma or melanoma. 13. the subject has a history of immunosuppression/immune deficiency disorders (including hiv infection or aids) or use of immunosuppressive medications. 14. the subject has an allergy to lidocaine and epinephrine.
a prospective evaluation of pain after non-complex ventral hernia repair

Conditions: Ventral Hernia

Summary: the study aims to evaluate outcomes relating to pain and qol after robotic-assisted or laparoscopic non-complex ventral hernia repair.

this is a prospective, observational, study across robotic-assisted and laparoscopic primary (non-recurrent) umbilical and incisional hernia repair. the study aims to evaluate pain and qol outcomes through 30 days. during the post-operative period through 30 days, pain medication intake, subject reported pain and quality of life and incidence of intra-operative and post-operative adverse events related to the ventral hernia repair will be collected.

Eligibility criteria:
inclusion criteria: 1. subject is between 18 and 80 years of age. 2. subject is a candidate for an elective primary (non-recurrent) ventral hernia repair. 3. ventral hernia repair that will require mesh placement exclusion criteria: 1. subject is contraindicated for general anesthesia or surgery. 2. subject with a ventral hernia that will require retromuscular mesh placement or employ a technique, including (but not limited to) external oblique release, rives- stoppa, etep rives-stoppa, transversus abdominis release, other component separation techniques (i.e. anterior component separation) or etep transversus abdominis release. 3. subject has a recurrent hernia. 4. subject who will have an emergent hernia repair. 5. subject with a history of chronic pain and/or taking daily pain medications for \>6 weeks. 6. subject with a history of substance abuse (excluding marijuana) and/or current (within 30 days) narcotic use. 7. current marijuana use that the subject is unwilling to discontinue within the 14 days prior to surgery. 8. subject with a history of mrsa infection. 9. subject with hba1c level \> 8.5%. 10. use of exparel during the surgical procedure. 11. subject who will undergo a concomitant hernia repair or any other concomitant procedure. 12. current nicotine use (including vaping) within the past 30 days. 13. subject has a known bleeding or clotting disorder. 14. pregnant or suspected pregnancy. 15. subject is mentally handicapped or has a psychological disorder or severe systemic illness that would preclude compliance with study requirements or ability to provide informed consent. 16. subject belonging to other vulnerable population, e.g, prisoner or ward of the state. 17. subject is currently participating in another interventional or investigational research study.
autologous bone marrow transplant for children with acute myelogenous leukemia (aml) in first complete remission

Conditions: Acute Myeloid Leukemia

Summary: this study proposes to transfer marker genes (detectable genetic traits or segments of dna that can be identified and tracked) into aliquots of marrow obtained for bone marrow transplant (btm) in patients in remission of acute myelogenous leukemia (aml).

the primary objective of this study was to estimate the continuous complete remission rate at 2 years post transplant for children with aml in first complete remission treated with autologous bmt. secondary objectives used transduction of marker genes into autologous marrow to determine the following: 1. whether the source of relapse after bmt for aml is residual malignant cells in the harvested marrow or in the patient, and whether marrow purging is therefore rational. 2. whether the majority of aml, which lack genetic markers, represent abnormalities in a multi-lineage progenitor cell, and whether therefore, auto grafting/intensified chemotherapy is ever likely to augment the cure rate. 3. the mechanisms of autologous reconstitution, and the effects of stimuli which modify the process.

Eligibility criteria:
inclusion criteria: * patients aged between 1 and 18 years at diagnosis with acute nonlymphocytic leukemia in first remission are eligible for this protocol. * patients enrolled on the aml-87 study in second or subsequent remission are eligible for this protocol. exclusion criteria: * has an hla-matched, mlc-compatible donor(unless parents and/or patient refuses transplant. * diagnosis of fab m3 or fab m3v (acute progranulocytic leukemia) * life expectancy limited by disease other than leukemia * significant cardiac disease (echo shortening fraction \<25% or muga scan \<50%) * severe renal dysfunction, i.e., creatinine clearance less than 60cc/1.73 m2/min * severe restrictive pulmonary disease (fcv less than 40% of predicted) * severe hepatic disease (bilirubin greater than 3 mg/dl or sgpt greater than 500iu) * severe personality disorder or mental illness * previous severe cystitis from cyclophosphamide * previous total dose of anthracyclines of \>450 mg/m2 * sever infection that on evaluation by the pi precludes ablative chemotherapy or successful transplantation * previous autologous transplant * hiv reactivity * karnofsky score \<70%

Keywords: autologous bone marrow transplant gene marking