Kornimate/medical-research-clean huggingface dataset:
over-the-scope clip versus through-the-scope clip for endoscopic hemostasis of high risk bleeding peptic ulcers

Conditions: Bleeding Peptic Ulcer

Summary: to compare in a multicenter, prospective, randomized, controlled trial the efficacy and safety of otsc versus tts clip for first-line hemostasis of high risk bleeding peptic ulcers

despite major advances in the management of non-variceal upper gastrointestinal bleeding (nvugib) over the past decade including prevention of peptic ulcer bleeding, optimal use of endoscopic therapy and high-dose proton pump inhibition, this still carries considerable morbidity, mortality and health economic burden of particular note are the re-bleeding rates, one of the most crucial predictive factors of morbidity and mortality that has not significantly improved as evident from longitudinal data in the past 15 years although huge advances have been made in terms of therapeutic endoscopic devices available today, complete haemostasis of complicated lesions (i.e. severe bleeding from large vessels or fibrotic ulcer) still remains a challenge and can be difficult to achieve. in particular, traditional clipping devices often appear technically difficult to place and insufficient to provide adequate tissue compression to obliterate large bleeding vessels. the over-the-scope clip (otsc) (ovesco endoscopy ag, tubingen, germany) system is a recently developed endoscopic device. in a preliminary experience, it has been successfully used in patients with severe bleeding or deep wall lesions, or perforations of the gi tract. recent retrospectives studies have demonstrated the efficacy and safety of otsc in patients undergoing emergency endoscopy for severe acute nvugib after failure of conventional techniques and as first-line to the best of the investigator's knowledge, no randomized clinical trial have been performed investigating the use of otsc as first-line endoscopic treatment in patients with high-risk nvugib.

Eligibility criteria:
inclusion criteria: * patients with suspected nvugib and subsequent endoscopic finding of peptic ulcer (ia-iib according to forrest classification) * age ≥ 18 years exclusion criteria: * patients who refused to participate at the trial * pregnancy
evaluation of coronary artery calcification using gated stationary chest tomosynthesis

Conditions: Coronary Artery Disease

Summary: the purpose of this study is to propose a new method for evaluating coronary artery calcium scores (cacs) in individuals with coronary artery disease.

the proposed research, if successfully implemented, will result in a new method for evaluating coronary artery calcium scores (cacs) in individuals with coronary artery disease. using the cardiac gated stationary chest tomosynthesis (cg-sdct) system the imaging dose for a a full tomosynthesis scan is expected to be only 10% of that from a low-dose ct. the targeted imaging time of 25-30 seconds is 1/2 of that from a current commercial dct system at the same imaging dose. as with current commercial dct systems, our s-dct system will expose patients to less radiation and deliver comparable data for cacs. cg-sdct will likely result in accurate cac scoring and allow for a more complete patient risk assessment as compared to framingham risk scoring alone.

Eligibility criteria:
inclusion criteria: 1. age range: ≥18 years of age 2. intermediate framingham risk score of 10 to 20% risk over the next 10 years 3. previous non-contrast enhanced chest ct in a time frame that will accommodate experimental imaging (cg-sdct) within 4 weeks. this imaging may have already been completed at the time of enrollment or may be scheduled in the future at the time of enrollment. 4. irb written informed consent obtained and signed exclusion criteria 5. negative urine pregnancy test in women of child-bearing potential (wcbp) within 1 week prior to s-dct. exclusion criteria: 1. unable to provide consent 2. pregnant or lactating 3. bmi \> 33 (patient who may not fit on a 35 x 35 detector) (images are not clear on subjects who have a greater than 33 bmi) 4. previous history of mi or thoracic surgery. 5. disability that could interfere with the scanning process, non-ambulatory or unable to hold their breath for up to 30 seconds. 6. planned procedures or therapies in between non-contrast ct scan and study chest tomosynthesis scan, e.g., line placement in the chest region, biopsy, etc.
measurement and modification of threat interpretation bias in neurodegenerative movement disorders (aims 2 & 3)

Conditions: Huntington Disease; Parkinson Disease

Summary: the purpose of this study is conduct a pilot open trial of a web-based cognitive bias modification intervention to reduce anxiety symptoms in persons with huntington's disease and persons with parkinson's disease.

after being informed about the study and giving informed consent, participants will enroll in a pilot open trial of mindtrails, a web-based cognitive bias modification intervention. participants will complete five, 20-minute mindtrails training sessions over five weeks. additionally, assessments of anxiety, interpretation bias, and other related outcomes will be completed at baseline, week 3, week 5, and 2 months following the last training session. participants will each complete a semi-structured interview to provide qualitative feedback about their experiences with mindtrails and anxiety.

Eligibility criteria:
inclusion criteria: * diagnosis of huntington's disease or parkinson's disease * age 21 or older * has anxiety symptoms (neuroqol anxiety short form \>12) exclusion criteria: * unable to read and understand english * previously diagnosed with dementia * not located in the usa

Keywords: anxiety interpretation bias cognitive bias modification
bundled intervention integrating mental health services in nepal

Conditions: Mental Health

Summary: globally, access to mental healthcare is often non-existent in rural, resource-deprived communities despite the pervasive need for services, particularly in post-conflict and post-disaster settings. we are developing and piloting will develop and pilot a culturally appropriate training model for non-specialist providers (nsps) to deliver high-quality mental health care over a period of 24 months in a primary care hospital in a rural district in nepal. we will employ a mixed methods framework to evaluate change in skills, knowledge, and attitude in nsp's, identify key mechanisms for continuum of mental healthcare delivery, and efficacy and cost-effectiveness in care delivery through a government hospital, clinics, and a network of community health workers. this integrated approach will introduce a bundled intervention that includes: both an on-site care coordinator and off-site psychiatric supervisors based in nepal's capital, kathmandu, weekly case conferences, and surveys of nsp's and clinical supervisors every six months during the study period. to learn about the acceptability, feasibility and challenges in the program we will also conduct focus group discussions among the pcps. in the last one year of the research in achham district we have seen increase in knowledge efficacy and skills among the nsps and also improved mental health care services at bayalpata hospital. our experience in achham motivated us to develop a similar program for charikot primary health center in dolakha district. outcomes of this study will focus on efficacy of this model to appropriately identify, counsel, and treat patients with depression, psychosis, and post-traumatic stress disorder (ptsd) through an integrated rural mental healthcare delivery intervention as a model for rural healthcare delivery.


Eligibility criteria:
inclusion criteria: * primary care provider (mbbs-level physician or health assistant) * current staff at healthcare facility in achham, bajura, or doti districts. exclusion criteria: * n/a

Keywords: continuing medical education chronic diseases nepal implementation research
a study of bay3427080 (nt-814) in the treatment of moderate to severe post-menopausal vasomotor symptoms

Conditions: Menopause; Hot Flashes; Night Waking

Summary: the purpose of this study is to determine the effectiveness of bay3427080 (nt-814), taken once a day, in the treatment of troublesome post-menopausal symptoms.

this is a multi-centre, multi-country, double-blind, randomised, placebo-controlled phase 2b study. the study will have a single-blind run-in period and will be adaptive with respect to the number of subjects recruited into each dose group. four doses of bay3427080 (40 mg once a day, 80 mg once a day, 120 mg once a day and 160 mg once a day) will be investigated and compared to placebo, in five parallel groups. subjects will participate in the study for a total of approximately 19 weeks, comprising a screening period of 1 week, a 14 week treatment period, and then a final follow up visit 4 weeks after the end of the treatment period. there will be a total of 8 visits whilst participating in the study. subjects will record their hot flashes in an electronic diary during the screening period to establish eligibility and throughout the study after randomisation.

Eligibility criteria:
key inclusion criteria: * postmenopausal * body mass index between 18 and 38 kg/m2, inclusive * subject experiences moderate or severe hot flashes key exclusion criteria: * inability to comply with the use of prohibited and allowed medications as described in the protocol. * any prior or ongoing history of clinically relevant drug or alcohol abuse within 12 months of screening. * any clinically significant prior or ongoing history of arrhythmias, either determined through clinical history or on ecg evaluation. * any clinically significant abnormal laboratory test result(s) measured at screening. * any active ongoing condition that could have caused difficulty in interpreting vasomotor symptoms. * uncontrolled hypertension. * a history or hyperthyroidism, hypothyroidism or abnormal thyroid function tests at screening. treated hypothyroidism with normal thyroid function test results at screening is acceptable.
coversin in paroxysmal nocturnal haemoglobinuria (pnh)

Conditions: Paroxysmal Nocturnal Haemoglobinuria (PNH)

Summary: coversin in paroxysmal nocturnal haemoglobinuria (pnh) in patients with resistance to eculizumab due to complement c5 polymorphisms.

coversin, a small protein complement c5 inhibitor which prevents the cleavage of c5 by c5 convertase into c5a and c5b, will be used in an open label, non-comparative clinical trial in patients with pnh and proven resistance to eculizumab due to c5 polymorphisms. patients will be treated with coversin by daily subcutaneous injection for 6 months in order to determine the safety and efficacy of the drug in these circumstances. if satisfactory control of the pnh is achieved, and at the discretion of the principal investigator (pi), patients will have the option of remaining on coversin and being entered into the long term follow-up study for 2 years. please note, 'coversin' is used throughout, but nomacopan is the official name/inn. please note, the end points were assessed for 6 months, but the adverse events were measured over the 2 year period.

Eligibility criteria:
inclusion criteria: * patients with known paroxysmal nocturnal haemoglobinuria (pnh) * ldh \>=1.5 upper limit of normal (uln) * resistance to eculizumab proven by both a recognised c5 polymorphism on genetic screening and complement inhibition on ch50 elisa of \<100% at concentrations of eculizumab in excess of 50 μg/ml * willing to self-inject coversin daily or to receive daily subcutaneous injections by a home nurse or in a doctor's office or hospital clinic * males or females taking adequate contraceptive precautions if of childbearing potential, 18 - 80 years of age * body weight ≥50kg and ≤ 100kg * the patient has provided written informed consent. * willing to avoid prohibited medications for duration of study * must agree to take appropriate prophylactic precautions against neisseria infection. * must be counselled regarding the possible reproductive risks of using coversin and be advised to use an adequate method of contraception pending further data on reproductive toxicology. exclusion criteria: * body weight \ 100kg * pregnancy (females) * failure to satisfy the pi of fitness to participate for any other reason * known allergy to ticks or severe reaction to arthropod venom (e.g., bee or wasp venom)
study of early versus delayed carotid endarterectomy (cea) for small to medium-sized ischemic stroke caused by high-grade carotid stenosis

Conditions: Stroke; Carotid Stenosis

Summary: pilot study of early versus delayed carotid endarterectomy (cea) for small to medium-sized ischemic stroke caused by high-grade carotid stenosis.

pilot study of early versus delayed carotid endarterectomy (cea) for small to medium-sized ischemic stroke caused by high-grade carotid stenosis.

Eligibility criteria:
inclusion criteria: * age 18 and older. * new small to medium-sized ischemic stroke (defined as less than 1/3 of the mca territory) in the territory of 70% or greater carotid stenosis. * women of child-bearing potential will be included only if there is a negative pregnancy test and they agree to birth control during the treatment period. exclusion criteria: * patients judged to be a poor surgical candidate by the treating physicians. * unstable neurological status.

Keywords: stroke carotid stenosis carotid endarterectomy timing
non invasive identification of gliomas with idh1 mutation

Conditions: Non Invasive Diagnosis of Glioma

Summary: the recurrent mutation idh1arg132his leads to the cellular accumulation of d-2-hydroxyglutarate (2-hg), thus representing a diagnostic marker (this change is almost specific for gliomas) and prognostic (mutated gliomas have longer survival) of interest. the main objective is to identify the patients with idh1 mutated glioma by three complementary approaches -genetic (identification of idh1 mutation in plasmatic dna), biochemical (2-hg dosage in the urine of patients) and radiological (2-hg

our preliminary results indicate an extremely high amount of d-2hg in gliomas and csf of the patients, and therefore the possibility to detect its presence by spectro-mri, and to establish a non-invasive diagnosis of glioma with idh1 mutation. our goal is to identify and quantify by high-field mri spectroscopy the presence of d-2hg to identify gliomas with idh1 mutation. in parallel, we developed a technique for selective amplification of the mutated form of idh1 (cold pcr): by combining this technique with digital pcr, we already are able to detect idh1 mutation from free plasma dna with a sensitivity of 58% and a specificity of 100%. at the same time we have shown that d-2hg levels in urine of patients correlate with the status of the tumor idh1. the main objective is to identify using this triple approach (detection of the mutation on plasma dna detection, detection of urinary d-2hg, detection of tumor d-2hg by spectro-mri) patients with idh1arg132his mutation, the secondary objective is to evaluate the value of these markers for patients follow-up and for differentiating recurrence from treatment induced damage. 40 patients with grade ii and grade iii gliomas (20 mutated, 20 non mutated) will be included and followed up for one year (five measurements are planned). the first interest is diagnostic: the presence of the idh1arg132his mutation allows the diagnosis of glioma. this information is particularly valuable in patients not amenable to biopsy, because of the location of the tumor considered at risk, the general condition of the patient or the co-morbidities and medications. we hope also with these parameters to better monitor patient's follow-up, and to have a new method to differentiate tumor recurrence and radionecrosis or post-radiation leukoencephalopathy.

Eligibility criteria:
inclusion criteria: inclusion criteria * affiliated to health insurance regimen (sécurité sociale) * patient of 18 years or more * written informed consent * glioma grade ii or iii histologically proven * frozen samples available * known status idh1/idh2 * presence of a measurable residual tumor (\> 2 cm in diameter flair) * karnofsky performance status (kps)\> 60 exclusion criteria: * contraindication to mri \* * the rare patients with idh2 mutation or with non arg132his idh1 mutation will be excluded * inability to provide informed consent * patient under guardianship or deprived of liberty by court

Keywords: glioma idh1 spectroscopy plasma
a phase 2a multicenter clinical trial of tb006 in participants with parkinson's disease

Conditions: Parkinson's Disease (PD)

Summary: the primary objectives of this study are to assess the efficacy of tb006 in improving motor function and to assess the safety of tb006 in participants with parkinson's disease (pd).


Eligibility criteria:
inclusion criteria: 1. participants voluntarily agree to participate in this study and sign an institutional review board (irb)-approved informed consent form (icf) prior to performing any of the screening procedures. parkinson's disease related criteria: 2. diagnosis of parkinson's disease (pd) with motor symptom improvement from levodopa, if applicable. 3. less than 5 years from the initial pd diagnosis, at the time of icf. 4. early-stage pd, with mild symptoms based on standard clinical staging in off state. 5. participants who are on immediate-release levodopa-carbidopa/benserazide. other health related criteria 6. no active cancer, unless in remission for ≥10 years without ongoing treatment, except fully removed basal cell carcinoma. 7. free of significant health issues that might interfere with study participation. other criteria/social circumstances 8. negative screening for illegal drugs (excluding cannabis), with willingness to abstain during the study and avoid cannabis or alcohol effects during visits. exclusion criteria: parkinsons's disease related criteria 1. history of sudden, unexpected pd medication off episodes. 2. severe motor complications or disabling symptoms that may impact study involvement. other health related criteria 3. any condition or health concern deemed a safety risk or likely to interfere with study results. 4. severe psychiatric disorders, including psychosis or substance addiction. 5. allergies or sensitivities to specific study-related treatments or substances. 6. any prior history of a severe infusion reaction. other criteria/social circumstances 7. pregnancy, breastfeeding, or plans for pregnancy or ova donation during or shortly after the study. 8. recent use of investigational drugs or therapeutic antibodies.

Keywords: pd tb006 monoclonal antibody parkinson's disease
melatonin effects on luteinizing hormone

Conditions: Hot Flashes

Summary: in many mammals, the duration of the nocturnal melatonin elevation regulates seasonal changes in reproductive hormones such as luteinizing hormone (lh). melatonin's effects on human reproductive endocrinology are uncertain. it is thought that the same hypothalamic pulse generator may both trigger the pulsatile release of gnrh and lh and also cause hot flashes. thus, if melatonin suppressed this pulse generator in postmenopausal women, it might moderate hot flashes. this clinical trial tested the hypothesis that melatonin could suppress lh and relieve hot flashes.

twenty postmenopausal women troubled by hot flashes underwent one week of baseline observation followed by 4 weeks of a randomized controlled trial of melatonin or matched placebo. the three randomized treatments were melatonin 0.5 mg 2.5-3 hours before bedtime, melatonin 0.5 mg upon morning awakening, or placebo capsules. twelve of the women were admitted to the gcrc at baseline and at the end of randomized treatment for 24-hour sampling of blood for lh. morning urine samples were collected twice weekly to measure lh excretion. subjective responses measured throughout baseline and treatment included sleep and hot flash logs, the cesd and qids depression self-ratings, and the saftee physical symptom inventory.

Eligibility criteria:
inclusion criteria: * postmenopausal woman * troubled by hot flashes exclusion criteria: * use of reproductive hormones other than continuous estrogen or progesterone hormone replacement * any acute illness * any anticipated changes of medication * anemia (hemoglobin \<12) or poor veins recent trans-time-zone jet travel, shift work, or irregular sleep habits any neurological or pituitary disease

Keywords: hot flashes melatonin depression sleep luteinizing hormone postmenopause
non-invasive chromosomal evaluation of trisomy study

Conditions: Aneuploidy; Trisomy 21; Trisomy 18; Trisomy 13; Down Syndrome

Summary: this study is being conducted to provide clinically annotated samples to support continued improvements in the ariosa test content, methodology, specimen processing and quality control.


Eligibility criteria:
inclusion criteria: * 1. subject is at least 18 years old and can provide informed consent; * 2. subject has a viable singleton or twin pregnancy; * 3. subject is confirmed to be at least 10 weeks, 0 days gestation at the time of the study blood draw; * 4. subject is planning to undergo cvs and/or amniocentesis for the purpose of genetic analysis of the fetus or the subject has already undergone cvs and/or amniocentesis and is known to have a fetus with a chromosomal abnormality confirmed by genetic analysis. exclusion criteria: * 1. subject has known aneuploidy; * 2. subject is pregnant with more than two fetuses or has had sonographic evidence of three or more gestational sacs at any time during pregnancy; * 3. subject has a fetal demise (including natural or elective reduction) identified prior to consent; * 4. subject has history of malignancy treated with chemotherapy and/or major surgery, or bone marrow transplant;

Keywords: aneuploidy down syndrome amniocentesis chronic villus sampling trisomy non-invasive prenatal testing chromosome disorders