Kornimate/medical-research-clean huggingface dataset:
study to assess adverse events and change in disease activity of oral cariprazine capsules in adult participants with schizophrenia

Conditions: Schizophrenia

Summary: schizophrenia is a common and severe psychiatric illness characterized by extreme disturbances of cognition and thought, affecting language, perception and sense of self. this study will assess how safe and effective cariprazine is in treating adult participants with schizophrenia in japan and taiwan. adverse events and change in disease activity will be assessed. cariprazine (vraylar) is an approved drug for the treatment of schizophrenia in the united states. in the first 6-week period, participants are placed in 1 of 2 groups, called treatment arms. each group receives a different treatment. there is a 1 in 2 chance that participants will be assigned to placebo. in the next 18-week period, participants will have the option to receive 1 of 3 doses of cariprazine. approximately 250 adult participants, 18-65 years of age with schizophrenia will be enrolled in approximately 55 sites across taiwan and japan. participants will receive oral capsules of cariprazine or placebo for 6 weeks. upon completion of 6-week treatment period, participants will be eligible to receive oral capsules of cariprazine for additional 18 weeks. the safety follow up period will follow after for an additional 8 weeks. there may be higher treatment burden for participants in this trial compared to their standard of care. participants will attend regular visits during the study at a hospital or clinic. the effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.


Eligibility criteria:
inclusion criteria: * diagnosed with schizophrenia at least 1 year before informed consent. * experienced a persistent psychotic episode within 2 months prior to informed consent requiring treatment modifications as judged by the investigator or sub-investigator. exclusion criteria: - history of clinically significant medical conditions or any other reason that the investigator (or subinvestigator) determines would interfere with the participant's participation in this study or would make the participant an unsuitable candidate to receive study drug.

Keywords: schizophrenia cariprazine vraylar
effect of abdominal massage on prevention of recurrent common bile duct stones after endoscopic sphincterotomy

Conditions: Common Bile Duct Stone; Abdominal Massage

Summary: endoscopic retrograde cholangiopancreatography (ercp) and endoscopic sphincterotomy (est) are the preferred techniques for treating common bile duct stones (cbds) due to their advantages of minimal trauma, rapid recovery, low cost, and high success rates of up to 95%. despite these benefits, the recurrence rate of cbds in patients after endoscopic therapy ranges from 4% to 25%, posing a significant challenge for endoscopists and an urgent problem to be addressed. abdominal massage is a promising non-invasive physical intervention for preventing recurrent cbds. this technique is a simple, effective, and non-invasive technique that can be utilized for patient self-management and is widely used in the field of digestive diseases. external pressure applied to the common bile duct during abdominal massage may promote bile excretion from the duct to the duodenum, similar to the effect of gallbladder movement flushing bile, which can prevent bile deposition in the common bile duct, thereby preventing the formation of new stones or flushing away newly-generated small stones. therefore, investigators plan to conduct a prospective, multicenter, randomized controlled study to investigate the preventive effect of abdominal massage in patients with recurrent cbds.


Eligibility criteria:
inclusion criteria: * age 18-75; * patients with common bile duct stones recurrence; exclusion criteria: * incomplete clearance of recurrent common bile duct stones; * anatomical changes (such as billroth i/ii, roux-en-y); * contraindications to abdominal massage (such as abdominal surgery, active gastrointestinal bleeding, intestinal obstruction, acute abdomen, etc.); * expected lifespan of less than two years; * unstable hemodynamics; * malignant arrhythmia; * pregnancy or lactation; * unwillingness or inability to sign an informed consent form.
imaging based uveitis screening for children with juvenile idiopathic arthritis

Conditions: Uveitis, Anterior; Juvenile Idiopathic Arthritis

Summary: this study seeks to describe, for children undergoing uveitis surveillance following a new diagnosis of juvenile idiopathic arthritis, the feasibility metrics of undertaking a randomised comparative study of routine slit lamp examination (sle) versus imaging based (anterior segment optical coherence tomography, oct) surveillance in order to inform the development of a larger multi-centre trial.

this study will compare imaging-based surveillance to routine clinical surveillance for uveitis in children with juvenile idiopathic arthritis (jia) in order to support the design of a future study. childhood uveitis is a rare inflammatory eye disease. half of all children with uveitis also have a joint disorder: juvenile idiopathic arthritis (or jia). children with jia must travel to a specialist centre every three months to have eye examinations in an attempt to pick uveitis up early enough to prevent visual loss. optical coherence tomography (oct) is a non-contact non-irradiating imaging modality. the investigators have recently demonstrated that novel application of oct for uveitis detection in children is feasible, acceptable to families, repeatable, sensitive, and specific. the investigators have also found that families welcome the objectivity of imaging-based diagnosis. standardised operating protocols for image acquisition and analysis have been developed across three imaging platforms (optovue, casia and heidelberg oct machines). the investigators will be undertaking a feasibility study which compares routine clinical examination based uveitis surveillance to imaging based surveillance in order to provide the necessary information to address this issue in a larger scale clinical trial of clinical and cost-effectiveness, and explore issues around the impact of objective disease metrics on family perceptions of disease and treatment, as well as the perceptions of children, families and clinical staff on the use of automated diagnostic tools.

Eligibility criteria:
inclusion criteria: * patients newly diagnosed (within preceding 12 months) with jia who are eligible for uveitis surveillance * aged 2-12 years exclusion criteria: * a previous / existing diagnosis of uveitis * any co-existing ocular or neurological abnormality which impacts on current corrected visual function, or could impact on future corrected visual function * developmental/learning difficulties that preclude concordance with examination / informed assent

Keywords: screening surveillance imaging optical coherence tomography
the effect of methylphenidate on motor learning in stroke patients

Conditions: Cerebrovascular Accident

Summary: the purpose of the study is to determine whether methylphenidate facilitates so called short-term plasticity as measures with transcranial magnetic stimulation, in patients with stroke.

stroke patients are to be examined with transcranial magnetic stimulation (tms) before and after a short training session. tms will be used to demonstrate changes in cortical excitability (motor threshold) and intracortical inhibition and facilitation. the effect of methylphenidate on baseline tms measures will be evaluated as well as the effect on training induced changes in tms measures (by comparing baseline and posttraining measures). the patients will be trained on two separate occasions, to compare the effect of methylphenidate to placebo.

Eligibility criteria:
inclusion criteria: * less than two months after first stroke. * moderate to light hand paralysis * measurable mep in the abductor pollicis brevis muscle * able to read and understand the written information * signed informed consent exclusion criteria: * epilepsy * glaucoma * hyperthyroidism * cardiac arrythmia * known heart disease or angina. * metal implants * pacemaker * pregnancy * diastolic bp\>100 mmhg * in treatment with mao-inhibitor, ssris og ritalin
study to evaluate safety and efficacy of allo-asc-sheet in subjects with dystrophic epidermolysis bullosa

Conditions: Dystrophic Epidermolysis Bullosa

Summary: after confirming eligibility, a single subject with four selected target lesions will receive both allo-asc-sheet and vehicle control, three target lesions for allo-asc-sheet and the other target for vehicle control, and which lesion to apply which ip treatment will be determined randomly at the time of enrollment using pre-designed block randomization scheme.

primary efficacy endpoint will be assessed during and after 12th ip applications.

Eligibility criteria:
key inclusion criteria: 1. subject diagnosed as dystrophic epidermolysis bullosa confirmed by clinical criteria and one of the following: 1. immunostaining test: patients who have reduced or no type 7 collagen in staining degree of immunofluorescence. other antigens (laminin-332, type 17 collagen, plectin, integrin α6β4, type 5 and type 14 keratin, etc.) are normal in immune-staining. 2. col7a1 mutational analysis: confirmation of col7a1 genetic mutation. 2. subject with skin ulcer lesions of dystrophic epidermolysis bullosa meet the following criteria, on the screening start day (visit 1) and treatment start day (enrollment day) (visit 3): 1. subject has two skin ulcer lesions judged as comparable to compare the safety and efficacy by investigator during screening period and prior to the ip application (enrollment day). 2. two skin ulcer lesions meeting criteria stated in 2a) should be sized 5-20 cm2 (inclusive) 3. subject who has two comparable target skin ulcer lesions, and each lesions with a change of size equal to or less than ±50% at treatment day (visit 3) compared to that of screening day (visit 1) 4. subject who has no clinical evidence of infection related signs/symptoms, or visible necrosis in the target skin ulcer area (area including ulcer lesion and surrounding area where the ip is to be applied). key exclusion criteria: 1. subject who requires antibiotics due to bacterial infection on skin of the target skin ulcer area (area including ulcer lesion and surrounding area where the ip is to be applied). 2. female subjects: pregnant woman (indicated by serum hcg test result at screening), breast-feeding patient, all sexually active patient, with child bearing potential in case of female\*, who is not willing to contracept\*\* during the clinical trial.
performance developement of patients with paraplegia during first rehabilitation

Conditions: Physical Activity

Summary: a high physical fitness is crucial for a good quality of life in persons suffering from a spinal cord injury. the aim of the present observational study is to investigate the influence of an individually tailored 8-week endurance training program on endurance performance of patients with a paraplegia during their first rehabilitation.


Eligibility criteria:
inclusion criteria: * written informed consent * male or female, paraplegia (ais a-c, lesion level th1-th12) * age 18-65 years * manual wheelchair user * patient during first rehabilitation exclusion criteria: * bmi ≥ 30 * unable to use an arm-crank ergometer due to e.g. spasticity * physical impairment, which makes it impossible to perform an arm-crank ergometry * progressive disease (g.g. tumor, ms) * ventilator dependent * existing cardiopulmonary disease * unstable medical situation
study of milk allergy and tolerance in children

Conditions: Food Hypersensitivity; Milk Hypersensitivity

Summary: the purpose of this study is to determine if children who are allergic to milk can increase tolerance through frequent dose-escalation every 6 months versus 12 months leading to eventual tolerance of less heated milk and ultimately unheated milk.

milk is among the most common food allergens in infants and children. the majority of children outgrow their milk allergies; however, the exact mechanisms by which food tolerance is achieved are unknown. strict avoidance of the offending food is currently the only known therapy. however, some have been known to tolerate milk products cooked at high heat such as when baked in foods. this clinical trial involves a diet containing extensively baked milk protein to investigate the effects of ingestion of heat-denatured milk on development of oral tolerance to non-baked milk.

Eligibility criteria:
inclusion criteria: one or more of the following inclusion criteria for enrollment in the study have to be met: * convincing history of an allergic reaction to milk or a positive double blind placebo controlled milk challenge (dbpcmc) within the past 2 years and either detectable milk immunoglobulin e (ige) or positive prick skin test to milk or * serum milk-ige of high predictive value \>14 kua/l or prick skin test to milk \> 10mm wheal within the past 6 months regardless of past clinical history of reactions or * convincing history of an allergic reaction to milk or a positive dbpcmc more than 2 years ago and either a positive serum milk-ige \< 14 kua/l or positive prick skin test to milk \< 10 mm wheal within the past 6 months (eligible only for the active arm of the study and will undergo a reversed sequence of initial baked-milk challenges) exclusion criteria: * inability or unwillingness of a participant to give written informed consent or to comply with study protocol

Keywords: food allergy milk allergy
evaluation of lofexidine for treatment of opioid withdrawal - 7

Conditions: Opioid-Related Disorders; Substance-Related Disorders

Summary: the purpose of this study is to determine the safety of lofexidine in the treatment of opiate withdrawal. preliminary data will also be obtained to assess the ability of lofexidine to alleviate opiate withdrawal signs and symptoms.


Eligibility criteria:
please contact site for information.
phase 2 study to evaluate lum001 in combination with ursodeoxycholic acid in patients with primary biliary cirrhosis

Conditions: PBC; Primary Biliary Cirrhosis

Summary: the study is a randomized, double-blind, placebo-controlled, multicenter study. it is a 13-week phase 2 study in adults with primary biliary cirrhosis designed to compare the effect of daily dosing with udca in combination with lum001 or placebo.


Eligibility criteria:
inclusion criteria: 1. diagnosis of primary biliary cirrhosis 2. moderate to severe pruritus 3. taking ursodeoxycholic acid (udca) for at least 6 months, or unable to tolerate udca 4. ability to understand and willingness to sign informed consent prior to initiation of any study procedures exclusion criteria: 1. history or presence of other concomitant significant liver disease 2. liver transplant 3. known hiv infection 4. women who are pregnant or lactating

Keywords: pbc
bioavailability study of ondansetron orally disintegrating tablets under fed conditions

Conditions: Healthy

Summary: to compare the single-dose bioavailability of ondansetron odt 8 mg and zofran 8 mg

to compare the single-dose bioavailability of kali's ondansetron odt 8 mg with that of glaxosmithkine's zofran 8 mg under fed conditions

Eligibility criteria:
inclusion criteria: * subjects meeting all of the following criteria may be included in the study * availability of subject for the entire study period and willingness to adhere to protocol requirements as evidenced by the informed consent from duly signed by the subject. * males and females aged from 18 to 50 years with a body mass index (bmi) within 19-30; demographic data (sex, age, ethnic group, body weight, height and smoking habits) will be recorded and reported in the final report. * clinical laboratory values within the laboratory's stated normal range; if not within this range, they must be without ant clinical significance and must be recorded as such in the crf ( laboratory tests are presented in section 7.1.3) * healthy according to the laboratory results and physical examination. * normal cardiovascular function according to the to ecg. * non or ex-smokers. exclusion criteria: * significant history of hypersensitivity to ondansetron or any related products as well as severe hypersensitivity reactions (like angioedema) to any drugs. * presence or history of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects. * presence or history of significant cardiovascular, pulmonary, hematologic, neurologic, psychiatric, endocrine, immunologic or dermatologic disease. * females who pregnant, lactating or are likely to become pregnant during the study phases. * females or childbearing potential who refuse to use an acceptable contraceptive regimen throughout the study. * positive pregnancy test before and during the study. * maintenance therapy with any drug, or significant history of drug dependency, alcohol abuse (\>3 units of alcohol per day, intake of excessive alcohol, acute or chronic), or serious psychological disease. * any clinically significant illness in the previous 28 days before day 1 of this study. * use of enzyme-modifying drugs in the previous 28 days before day 1 of this study (all barbiturates, corticosteroids, phenylhydantoins, etc.) * participation in another clinical trial in the previous 28 days before day 1 of this study. * donation of 500 ml of blood (canadian blood services, hema-quebec, clinical studies, etc.) in the previous 56 days before day 1 of this study. * positive urine screenings of drugs of abuse (drug names are presented in section 7.1.4). * positive results to hiv, hbsag or anti-hcv tests. * history of fainting upon blood sampling.

Keywords: bioequivalence ondansetron odt fed to determine bioequivalence under fed conditions
optimal type 2 diabetes management including benchmarking and standard treatment in ceemea

Conditions: Diabetes Mellitus, Non-Insulin-Dependent

Summary: optimise-ceemea is a multinational, multi-centre, observational, prospective study which will include patients suffering from diabetes type 2, treated or untreated, insulin dependent or not insulin dependent. in this study we aim to explore at a primary care level whether the use of benchmarking against a set of guideline-based reference values on a patient basis, may improve quality of patient care, in particular control of diabetes, lipids and blood pressure.


Eligibility criteria:
inclusion criteria: * subjects suffering from diabetes type 2, * treated or untreated, * insulin dependent or not insulin dependent able to read and send sms (if sms applicable) exclusion criteria: * type 1 diabetes pregnancy diabetes * hospitalization at the moment of enrollment in the study

Keywords: benchmarking could improve quality of patient care esc and atp iii guidelines
the effect of atorvastatin 80 mg on hs-crp/albumin ratio in reducing thrombus burden in pci-stemi patients

Conditions: STEMI (STE-ACS); Primary PCI for STEMI

Summary: 40 stemi patients who underwent primary pci were subsequently allocated into two groups via a double-blind randomization method: an atorvastatin 80 mg group and the control group. levels of hs-crp and albumin were assessed for both groups upon presentation at the emergency department before to initial pci and were re-evaluated 24 hours after primary pci. thrombus burden was assessed using angiography with the timi thrombus grade.

this study encompasses 40 stemi patients who underwent primary pci at dr. moewardi general hospital in central java, indonesia, between september and october. this study employed an experimental design with a pre-and-post technique, with participants recruited through sequential sampling. patients were subsequently allocated into two groups via a double-blind randomization method. a treatment group was administered a loading dose of high-intensity statin (80 mg atorvastatin) upon initial presentation at the emergency department (ed), whereas the control group received no such intervention. both cohorts received therapy in accordance with established guidelines prior to performing primary pci. levels of hs-crp and albumin were assessed for both groups upon presentation at the emergency department before to initial pci. in the treatment group, a second 80 mg dose of atorvastatin was provided 24 hours after the original dose. both hs-crp and albumin levels were re-evaluated 24 hours after primary pci in both the control and treatment cohorts. thrombus burden was assessed using angiography with the timi thrombus grade

Eligibility criteria:
inclusion criteria: * stemi with onset less than 24 hour and undergo a primary pci exclusion criteria: * stemi beyond 24 hours from the onset of chest pain * prior statin therapy within the preceding 24 hours * hypersensitivity to statins, pregnancy, lactation, severe inflammatory conditions including active liver dysfunction, chronic kidney disease (egfr \<30 ml/min), autoimmune disorders, malignancy, severe malnutrition, and * contraindications to statin administration.

Keywords: atorvastatin hs-crp albumin timi thrombus grade thrombus burden
clinical results of implant-retained mandibular overdentures in edentulous patients

Conditions: Edentulous

Summary: the purpose of this study is to evaluate the clinical results of implant-retained mandibular overdentures in edentulous patients.

the survival of implants,condition of the peri-implant soft tissue were evaluated. and patients' perceptions regarding the outcome were assessed on visual analog scales (vas), oral health impact profile-14 (ohip) and semantic differential scale questionnaires.

Eligibility criteria:
inclusion criteria: 1. patients treated with implant retained overdentures 2. with the ability to read and sign the informed consent document exclusion criteria: 1. jaw radiotherapy treatment before and after implanting 2. patients who suffered with mental and psychological disease will influence their oral health normal maintenance 3. can not read and sign the informed consent document