Kornimate/medical-research-clean huggingface dataset:
nopho all-2008 pilot study on consolidation therapy for children and adolescents with acute lymphoblastic leukemia

Conditions: Leukemia, Lymphocytic, Acute

Summary: the present pharmacokinetic (pk)-pharmacodynamic (pd) study will explore the toxicity and antileukemic response during the initial 3 months of individualised therapy of children and young adults with acute lymphoblastic leukemia (all). the investigators will on an individual toxicity-titrated basis attempt to increase the dose intensity of the 6-mercaptopurine used in the two-months post-remission treatment phase of lower risk childhood all. this will be performed together with continuous peg-asp (every 2nd week) and interspersed hd-mtx (5 g/m\^2) every 3rd week. thus, the trial will also test the feasibility of this particular drug combination.

in addition to the details above we will also explore * the relationship of the post-hd-mtx mrd-levels with the dose of 6mp, tpmt-activity, dna-6tgn, e-6tgn, e-memp, e-mtx, and presence of asp-antibodies, * the early development of anti-asp antibodies during continuous peg-asp therapy. the study could improve the understanding of the pharmacodynamics of the 6mp/hd-mtx interaction in combination with peg-asp.

Eligibility criteria:
inclusion criteria: * b-lineage all * 1-17.9 years * wbc \<100, clinical remission obtained day 2 * written consent to participation. exclusion criteria: * t(9;22) * hypodiploidy * 11q23-aberrations * tpmt-deficiency * intolerance to mtx or 6mp

Keywords: leukemia, lymphocytic, acute [c04.557.337.428.511] 6-mercaptopurine methotrexate asparaginase
evaluation of vidiac scores of obese and non-obese patients intubated by videolaryngoscopy

Conditions: Vidiac Score; Videolaryngoscopy; Obesity

Summary: the aim of the study was to observe the vidiac score values of only patients with obesity as a risk factor for difficult intubation. secondly, it was aimed to evaluate the number of intubation attempts and intubation time, vidiac scores between non-obese and obese patients and to reveal the differences, if any.


Eligibility criteria:
inclusion criteria: * all patients to be operated under general anesthesia and endotracheal intubation exclusion criteria: 1. under 18 years old 2. the patient's refusal 3. difficult airway story before 4. congenital or previous airway anatomical disorder 5. patients who have undergone airway surgery 6. patients with a mass in the head and neck region
external trigeminal nerve stimulation for epilepsy

Conditions: Epilepsy; Seizure Disorders

Summary: this study investigates a new therapy for epilepsy called trigeminal nerve stimulation (tns). tns involves external electrical stimulation of sensory nerve located above the eyes and over the forehead. the purpose of this study is to determine if tns is safe and effective using a rigorous randomized active-control clinical trial design in 50 people with epilepsy.

poorly controlled epilepsy is a disabling condition, affecting over one million americans. neurostimulation is a promising alternative for patients who have failed medical therapy, and who are not resective surgical candidates. trigeminal nerve stimulation (tns) is a novel form of neurostimulation, and has a strong antiepileptic effect in an animal model of seizures. preliminary data in humans indicates tns is well tolerated and may be effective in people with intractable epilepsy. tns is an alternative mode of neurostimulation, because the trigeminal nerve can be stimulated in minimally-invasive fashion. this is a randomized double blind study of trigeminal nerve stimulation, which compares high stimulation to an active control. subjects with poorly controlled partial onset seizures who meet all inclusion and exclusion criteria, enter a 6-week baseline period, and then are randomized in double-blind fashion to high or low intensity stimulation for 18 weeks. 50 subjects are to be enrolled at two sites. study outcomes are the following: 1. percent change in seizure frequency during the treatment period compared with the baseline (pre-treatment) period. 2. time to the 4th seizure the primary comparisons will be between and within groups.

Eligibility criteria:
inclusion criteria: * ages 18 - 70; * no serious or progressive medical illness; * a history of intractable partial seizures; * at least two complex partial or tonic clonic generalized seizures per month in the last two consecutive months; * mri or eeg consistent with localization-related or partial epilepsy; * exposure to at least two antiepileptic drugs at adequate doses; * concurrent use of at least one antiepileptic drug at adequate doses; * no change in antiepileptic dose for at least 30 days before study enrollment exclusion criteria: * history of non-epileptic seizures; * inability to maintain accurate seizure calendars (self or caregiver); * frequent use of benzodiazepines for clusters defined as greater than four times a month; * history of facial pain or trigeminal neuralgia; * concurrent vagus nerve stimulation; * pregnancy

Keywords: partial seizures poorly controlled epilepsy intractable epilepsy treatment resistant epilepsy trigeminal nerve trigeminal nerve stimulation
dcp3 based multi-component intervention for hypertension management and control

Conditions: Hypertension; Hypertensive Patients

Summary: this study aims to enable delivery of a multi-component intervention comprising of strategies based on disease control priorities 3rd edition for management of hypertension among hypertensive patients. the secondary objective is to test the feasibility, acceptability and adaptability of a multi-component intervention delivered at a tertiary level health-care facility in the cultural context of pakistan. a formative research study was conducted before so as to develop and test the intervention in a tertiary care hospital setting. the investigators employed qualitative research methods to explore the feasibility, applicability, and acceptance of dcp3 based intervention comprising of strategies for hypertension management. focus group discussions and in-depth interviews with selected study participants were conducted at armed forces institute of cardiology (afic/nihd), rawalpindi for which a prior written and verbal consent was obtained from all research participants. the study adhered to the ethical principles of involving human subjects in the research. all information provided by the participants was recorded and was kept strictly confidential.


Eligibility criteria:
inclusion criteria: * • pakistani nationals both male and female of age 18 years and above will be invited to participate in the study * similarly; known hypertensive patients having a systolic blood pressure of ≥140 mmhg on current treatment will be included \& * patients with co-morbidities will also be included such as those suffering from cardiac ailments (angina or transient ischemic attack (tia) and diabetes exclusion criteria: * • patients with compromised neurological or cognitive state who are unable to provide their consent will be excluded * patients suffering from non-cardiovascular diseases and life-threatening illnesses such as angiographically proven coronary disease, peripheral or cerebral vascular disease, pulmonary hypertension, having history of myocardial infarction, stroke/pci/stent or high-risk conditions will be excluded from participation * patients with chronic conditions and co-morbidities requiring surgical intervention or treatment such as cardiomyopathies or congenital abnormalities \& * patients receiving dialysis will also be excluded from the study
prospective clinical trial for children with tcrαβ depleted vs traditional haplo identicle hsct

Conditions: Graft-Versus-Host Disease; Hematopoietic Stem Cell Transplantation; Child, Only; Haploidentical Hematopoietic Stem Cell Transplantation

Summary: this is a single-center prospective, non-randomized controlled clinical study in china using clinimacs tcrα/β+ cell depleted stem cell haploidentical donors versus conventional beijing protocol for haploidentical hematopoietic stem cell transplantation in children.

1:1 non-randomized controlled clinical study in single center using clinimacs tcrα/β+ cell depleted stem cell versus conventional beijing protocol for haploidentical hematopoietic stem cell transplant. the purpose of this study is to obtain 30% decrease grade ii-iv agvhd and better qulity of life for tcrα/β+ cell depleted haploidentical stem cell transplantaion.

Eligibility criteria:
inclusion criteria: * age 8 weeks to 18 years * children who meet the indicators haploidentical hematopoietic cell transplantation * no hla ≥ 9/10 donor or not suitable for this type of donor due to illness * informed consent must be signed (by the patient or legal representative) exclusion criteria: * liver function abnormalities with bilirubin \>2 mg/dl and elevation of transaminases higher than 400 u/l * chronic active viral hepatitis * ejection fraction \<50% * respiratory failure necessitating supplemental oxygen * patients with a history of psychiatric illness or a condition which could interfere with their ability to understand the requirements of the study * patients unwilling or unable to comply with the protocol or unable to give informed consent * concurrent severe or uncontrolled infection
portable oxygen concentrator (poc) versus standard of care in long-covid: randomized crossover exploratory pilot study.

Conditions: COVID-19

Summary: a prospective, open label, randomized, crossover, pilot, exploratory study to describe the effect of the inogen one® g4 poc on brain hypoxia, peripheral oxygen saturation and cognitive function in adults with longterm- covid.

after a 2-week screening/baseline evaluation, participants will be randomized in a 1:1 allocation ratio to one of the following 2 sequences: 1) portable oxygen concentrator (poc) for a first 2-week period followed by standard of care (soc) for a second 2-week period or 2) soc for a first 2-week period followed by poc for a second 2-week period. there will be a washout period of one week between the two treatment periods. a total of 10 subjects will be enrolled per sequence.

Eligibility criteria:
inclusion criteria: 1. ability and willingness to give written informed consent prior to any study-specific screening procedures and to comply with the requirements of the study 2. male or female, aged ≥ 18 years of age 3. diagnosed with long-covid 4. patient self-reported concerns regarding cognitive functioning or recent diagnosis of covid-19 related cognitive impairment 5. moca test scores ranging from 13 to 25/30 at screening 6. oxygen saturation spo2 ≤ 93 % on fingertip pulse oximetry and/or \< 60% on brain nirs, at rest or during effort and/ or 10% relative decrease in brain saturation during exercise as compared to baseline value at screening 7. ability to perform exercise treadmill test at screening 8. tolerability of pulsed oxygen (o2) therapy delivered by poc at screening 9. willingness and ability to wear poc. exclusion criteria: 1. contraindication to the use of poc including allergy to cannula material 2. pregnancy or planning to become pregnant during the study 3. non-covid-related cause for cognitive impairment (such as parkinson's disease, multiple sclerosis, alzheimer's disease, stroke, brain tumor, or dementia) 4. subjects with respiratory infection at screening or randomization and/or acute bronchitis requiring antibiotics at the time of randomization or expected during the treatment 5. participation in other interventional clinical trial within 30 days of randomization or expect to participate in any other investigational clinical trial during the conduct of this trial 6. subjects who should be excluded in the opinion of the investigator
bee venom for the treatment of parkinson disease

Conditions: Parkinson Disease

Summary: the purpose of this study is to evaluate the efficacy of repeated (monthly) injections of bee venom on motor symptoms of parkinson's disease over a period of one year, also the potential effects of this treatment on disease progression compared to placebo (saline injections).

the investigators plan to assess the potential efficacy of repeated (monthly) injections of bee venom on the motor symptoms of parkinson disease over a period of one year. the investigators will also assess the potential effects of this treatment on disease progression. all assessments will be conducted in comparison to placebo (saline injections).

Eligibility criteria:
inclusion criteria: * patients suffering from parkinson disease according to the parkinson's disease society brain bank criteria (hughes et al., 1992) * age \> 40 ans (exclusion of juvenile forms) * hoehn and yahr stage 1,5-3 off * pathological datscan * mri excluding atypical or secondary forms of parkinsonism * negative testing to bee venom (intradermoreaction) * affiliated to the french social security system exclusion criteria: * parkinson disease hoehn \& yahr stage \ 3 * positive intradermoreaction to bee venom * ige positive to bee venom * known allergy to bee venom * contra-indications to treatment with bee venom (alyostal®) * atypical or secondary parkinsonian syndrome (verified by mri) * treatment with antipsychotics over the past 6 months * cardiac, hepatic or renal failure * normal datscan * contra-indications to mri scanning * pregnancy * major depression or other severe acute/ongoing psychiatric disorder * cognitive impairment (mms \>24) * patient under guardianship

Keywords: parkinson disease bee venom motor fluctuations disease progression
supervised brushing programme for intellectual disabled students

Conditions: Oral Health; Intellectual Disability; Randomized Controlled Trial

Summary: intellectual disabled persons faced more dental problems. according to a medical review paper of international and local studies, this group has poorer dental hygiene, more severe gum disease and more untreated caries. in 2010, a report from the guardians in hong kong mentioned that most adults with intellectual disability cannot clean their teeth, the have dental problems and it is very difficult for intellectually disabled students to co-operate during the dental treatment. in order to alleviate their dental problems, supervised toothbrushing programme and an oral health education talk are proposed. the investigators investigate the effectiveness of the supervised toothbrushing programme and an oral health education talk. the target group of the study is mild to moderate grade intellectual disabled students of special schools in hong kong. a clustered randomised controlled trial design is adopted.

intellectual disabled persons faced more dental problems. according to a medical review paper of international and local studies, this group has poorer dental hygiene, more severe gum disease and more untreated caries. in 2010, a report from the guardians in hong kong mentioned that most adults with intellectual disability cannot clean their teeth, the have dental problems and it is very difficult for intellectually disabled students to co-operate during the dental treatment. in order to alleviate their dental problems, supervised toothbrushing programme and an oral health education talk are proposed. the investigators investigate the effectiveness of the supervised toothbrushing programme and an oral health education talk. the target group of the study is mild to moderate grade intellectual disabled students of special schools in hong kong. a clustered randomised controlled trial design is adopted.

Eligibility criteria:
inclusion criteria: * mild and moderate grade intellectual disabled students in special schools. exclusion criteria: * 1. those students who have simultaneously joined other oral health programme during the study period. * 2. those students with the presence of conditions rendering a need of antibiotic prophylaxis prior to periodontal examination e.g. rheumatic heart disease. * 3. uncooperative students that oral examination is not possible.
a study to evaluate the efficacy and safety of tnx-102 sl in patients with fibromyalgia

Conditions: Fibromyalgia

Summary: this is a phase 3, randomized, parallel-group, double-blind, placebo-controlled, 14-week study designed to evaluate the efficacy and safety of tnx-102 sl 5.6 mg (2 x 2.8 mg tablets) taken daily at bedtime for the treatment of fibromyalgia.


Eligibility criteria:
inclusion criteria: * the patient is male or female 18 to 65 years of age, inclusive. * the patient has a diagnosis of primary fm as defined by the 2016 revisions to the 2010/2011 fibromyalgia diagnostic criteria (american college of rheumatology preliminary diagnostic criteria) * the in-clinic 7-day recall nrs average daily pain intensity score at screening visit within protocol specified range. exclusion criteria: * history of or evidence for a diagnosis of borderline personality disorder (bpd).

Keywords: pain sleep fibromyalgia fm
a clinical study to assess the efficacy and safety of dexamethasone suspension for cataract surgery

Conditions: Inflammation Eye

Summary: patients at least 40 years of age who are undergoing cataract surgery will be randomized to receive treatment with one of two dose levels of dexamethasone ophthalmic suspension eye drops to determine if the drops decrease inflammation inside the eye and are safe after cataract surgery.


Eligibility criteria:
inclusion criteria: * male or female patients at least 40 years of age scheduled for unilateral cataract surgery by phacoemulsification with posterior chamber intraocular lens implantation. exclusion criteria: * patients who have received a periocular corticosteroid injection in the study eye in the 3 months prior to screening. * patients who anticipate requiring treatment with any corticosteroids by any route, except inhalation, during the study. * patients who are known steroid responders
the mobile diabetes mgmt. study with type 2 diabetes

Conditions: Type 2 Diabetes

Summary: a multi-center, randomized, parallel, open clinical trial to evaluate the glycemic control effect of the mobile healthcare service using u-healthcare clinical decision support system (cdss) and u-healthcare gateway in patients with type 2 diabetes mellitus

the mobile diabetes intervention study is evaluating a diabetes mgmt. algorithm system by using patient mobile application and physician web-based portal. the investigators hypothesize that patient self-monitoring of blood glucose, dietary and exercise by using application and physician's remote monitoring can additional decrease of hba1c over 6 month.

Eligibility criteria:
inclusion criteria: * 20-80 years of age * type 2 diabetes patients (who have taken stably oral diabetic drugs or insulin, and been doing lifestyle improvement by doctor's advice for recent over 3 months) * in case insulin treated, patients with basal insulin once a day or premixed insulin twice a day * hba1c between 7.0% and 10.0% * ability to understand and use smartphone application exclusion criteria: * type 1 diabetes or patients using insulin pump * severe complications (stage iv,v chronic kidney failure, diabetic food complications, unstable angina pectoris, mi or stroke, surgical procedure of coronary \& peripheral artery within recent 6 months) * uncontrolled hypertension * pregnant woman, fertile woman who will not use contraception * unable to use application during treatment * taking medication which can affect on glucose level * alcohol abuse or dependency * over 2.5 times from the upper limit of liver enzyme level * dka(diabetic ketoacidosis) or hhs(hyperglycemic hyperosmolar syndrome) history during recent 6 months

Keywords: mobile application diabetes management
heartlight guided - pure pulmonary vein isolation regardless of concomitant atrial substrate

Conditions: Atrial Fibrillation

Summary: aim of the present prospective, single-centre study is to determine the outcome after pure pvi using heartlight™ in 100 patients with different extents of la-lva. the latter will be assessed by an electro-anatomical voltage map using a commercial 3d mapping system (carto, biosense webster).

the ablation strategy for patients with atrial fibrillation (af) and concomitant atrial substrate (e.g. low-voltage areas; lva) is a matter of controversy. results of studies investigating the impact of lva may have been confounded by pv-to-left-atrial (la) reconnection due to non-durable ablation. therefore, the true contribution of la-lva to af recurrences remains unknown. meanwhile, new ablation technologies such as the heartlight™ laser balloon (lb) ablation system providing near complete chronic pvi rates have been developed. aim of the present prospective, single-centre study is to determine the outcome after pure pvi using heartlight™ in 100 patients with different extents of la-lva. the latter will be assessed by an electro-anatomical voltage map using a commercial 3d mapping system (carto, biosense webster).

Eligibility criteria:
inclusion criteria: * symptomatic atrial fibrillation * left atrial size \<50mm * left ventricular ejection fraction \<45% * patient is able to provide informed consent exclusion criteria: * contraindications for pvi * previous pvi attempts * inability to be treated with oral anticoagulation * presence of intracardiac thrombi * pregnancy * participation in other clinical studies * unwilling to follow the study protocol and to attend follow-up visits
computed radiography (cr) data collection for mammography computer aided detection (cad)

Conditions: Breast Cancer

Summary: the objective of this study is to collect an image library of diagnostic digital mammograms using the carestream cr mammography system from patients who have histological-conformed breast cancer to demonstrate the clinical feasibility of this system for detection of breast cancer.


Eligibility criteria:
inclusion requirements * women age 40 to 85 * recommended for biopsy and bi-rads assessment of category 4 (suspicious abnormality) or 5 (highly suggestive of malignancy) * able to have mlo and cc views taken * good general health * able and willing to provide a written informed consent exclusion requirements * under age 40 * pregnant or suspicious of being pregnant * breast implants * breasts too large to be adequately positioned on a 24 x 30 cassette * personal history of breast cancer treated with a lumpectomy * unable or unwilling to provide a written informed consent form