Kornimate/medical-research-clean huggingface dataset:
effects of foot muscle strengthening in daily activity in diabetic neuropathic patients

Conditions: Diabetic Neuropathies

Summary: the main objective of this trial is to investigate the effects of foot muscle strengthening in daily activity of patients with diabetic neuropathy.

a randomized controlled trial will be performed with 77 patients with diabetic neuropathy. the participants will be randomly assigned into either a control group (recommended foot care by international consensus with no exercises) or an intervention group which will receive 12-week physical therapy exercises, twice a week, under the supervision of a physiotherapist, and twice a week being remotely supervised by a software at home. every exercise has its own progression depending on the subjects' execution, increasing in intensity and difficulty. the subjects will be evaluated in 5 different moments (baseline, 6 weeks, 12 weeks, 24 weeks and 1 year follow-up) the hypothesis of this study is that the intervention group will increase daily activity levels, increase self-selected and rapid walking speed, reduce the incidence of plantar ulcers, increase foot health and functionality, improve symptoms, increase tactile and vibration sensitivity, increased passive range of motion, improved quality of life, increased isometric strength of the feet and production of beneficial biomechanical changes during walking compared to the control group after 12 weeks of intervention and follow-up year.

Eligibility criteria:
inclusion criteria: * diabetes mellitus type 1 or 2 * moderate or severe polyneuropathy confirmed with the fuzzy software * ability to walk independently in the laboratory * accessibility to electronic devices * loss of at least 4 degrees of ankle range of motion * loss of at least 1 degree of force in the clinical scale of the plantar interosseous or lumbrical muscles exclusion criteria: * ulceration not healed for at least 6 months * hallux amputation or total amputation of the foot * receiving any physiotherapy intervention or offloading devices * neurological or orthopedic impairments * major vascular complications * severe retinopathy

Keywords: diabetic foot therapeutic exercises foot preventive care rehabilitation diabetic neuropathy
bioequivalency study of montelukast 10 mg tablets under fasted conditions

Conditions: Asthma

Summary: the objective of this study was to prove the bioequivalence of montelukast tablet under fasted conditions


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening exclusion criteria: * positive test for hiv, hepatitis b, or hepatitis c. * treatment with known enzyme altering drugs. * history of allergic or adverse response to montelukast or any comparable or similar product.
the efficacy of treadmill training in establishing walking after stroke

Conditions: Stroke

Summary: being able to walk is a major determinant of whether a patient returns home after stroke or lives in residential care. for the family, the loss of the stroke sufferer from everyday life is a catastrophic event. for the community, the costs of being unable to walk after stroke are exorbitant, involving a lifetime of residential care. therefore, an increase in the proportion of stroke patients who regain walking ability will be a significant advance. this trial will determine, in patients early after stroke who are unable to walk, whether training walking using a treadmill with partial weight support via an overhead harness will be more effective than current intervention in (i) establishing more independent walking, reducing the time taken to achieve independent walking, and improving the quality of independent walking, and (ii) improving walking capacity and participation 6 months later.

only half of the stroke patients unable to walk who are admitted to inpatient rehabilitation in australia learn to walk again. treadmill training with partial weight support is a relatively new intervention that is designed to train walking. however, a cochrane systematic review (moseley et al 2003) concludes that there is as yet no definitive answer about whether this intervention helps more non-ambulatory patients learn to walk compared to assisted overground walking. participants will be 130 stroke patients who are unable to walk independently early after stroke. they will be recruited and randomly allocated to a control group or an experimental group. the control group will undertake routine assisted overground walking training while the experimental group will undertake treadmill walking with partial weight support via an overhead harness. duration and frequency of intervention and the amount of assistance from therapists will be standardised across groups.

Eligibility criteria:
inclusion criteria: * first stroke * within 28 days post stroke * aged between 50 and 85 years of age * unilateral hemiplegia/hemiparesis and * score for item 5 of the motor assessment scale for stroke \< 2 exclusion criteria: * any barriers to taking part in a physical rehabilitation program * insufficient cognition/language * unstable cardiac status * neuro-surgery * any pre-morbid history of orthopaedic conditions or any other problems that would preclude patient from relearning to walk.

Keywords: stroke health outcomes physiotherapy rehabilitation treadmill
non-interventional post marketing surveillance study to observe the safety and efficacy of vfend® tablet in korea

Conditions: Serious Fungal Infections

Summary: this is a non-interventional study of voriconazole tablet in korea which is mandated by the korean government agency.


Eligibility criteria:
inclusion criteria: * patients who are indicated for voriconazole table according to the drug package insert. exclusion criteria: * none.

Keywords: voriconazole korea invasive fungal infection
feasibility, acceptability and directional signal effect on blood folate levels of iodized salt fortified with folic acid: clinical study

Conditions: Neural Tube Defects; Folic Acid Deficiency; Fortification

Summary: aim 1: assess directional signal of effect of fortified salt with folic acid and iodine on blood serum folate levels. it will be accomplished by feasibility pre-test/post-test clinical study by estimating mean and variability of serum blood folate levels effects of folic acid fortified salt. hypothesis: fortified salt with folic acid and iodine will increase serum blood folate levels from baseline by month 1. aim 2: assess feasibility and acceptability of salt fortified with folic acid and iodine. feasibility will be measured by 1) subjects' refusal rate of consent by 30 subjects during 6-month enrollment period; 2) method of determining salt consumption (weighting the saltshaker pre and post); 3) completion rates of study protocols from baseline to follow up. hypothesis 1a: completion of all blood draw visits will be 90-100%. acceptability will be measured by 1) completion rate of daily salt logs; 2) consumption of salt by weighting saltshakers; 3) attitude towards taste and color difference. hypothesis 1b: completion rate (90-100%) of daily salt logs will range from 90-100% of participants and 2) consumption of salt will range from 90-100% of participants. dietary surveys will be employed to document dietary habits and estimated daily fa intake in the sample population. feasibility and acceptability of dietary surveys will be measured by willingness to answer survey questions. hypothesis 1c: completion rate of dietary surveys will range 90-100%.


Eligibility criteria:
inclusion criteria: * women * consumes salt exclusion criteria: * pregnant or intends to become pregnant in next 6 months

Keywords: serum folate
a study of prt543 in participants with advanced solid tumors and hematologic malignancies

Conditions: Relapsed/Refractory Advanced Solid Tumors; Relapsed/Refractory Diffuse Large B-cell Lymphoma; Relapsed/Refractory Myelodysplasia; Relapsed/Refractory Myelofibrosis; Adenoid Cystic Carcinoma; Relapsed/Refractory Mantle Cell Lymphoma; Relapsed/Refractory Acute Myeloid Leukemia; Refractory Chronic Myelomonocytic Leukemia

Summary: this is a phase 1 cohort, dose-escalation, dose-expansion study of prt543 in patients with advanced cancers who have exhausted available treatment options. the purpose of this study is to define a safe dose and schedule to be used in subsequent development of prt543.

this is a multicenter, open-label, sequential-cohort, dose-escalation, dose-expansion phase 1 study of prt543 in patients with advanced cancers who have exhausted available treatment options. enrollment will take place concurrently into two distinct patient groups (one for solid tumors/lymphomas and one for hematological malignancies). the study will consist of 2 parts, a dose escalation part, and once the recommended phase 2 dose (rp2d) has been determined, a cohort expansion part involving up to ten separate cohorts. for patients, the study will include a screening phase, a treatment phase, and a post treatment follow-up phase. an end-of-study visit will be conducted within 30 days after the last dose of prt543.

Eligibility criteria:
inclusion criteria: * metastatic or advanced solid tumor; or advanced diffuse large b-cell lymphoma; or advanced mantle cell lymphoma; or relapsed myelodysplastic syndrome, acute myeloid leukemia or chronic myelomonocytic leukemia; or relapsed myelofibrosis. all malignancies must be refractory to established therapies * biomarker-selected solid tumors * eastern cooperative oncology group (ecog) performance score of 0 or 1 * adequate organ function (bone marrow, hepatic, renal, cardiovascular) * female patients of childbearing potential must have a negative pregnancy test within 7 days of the start of treatment and must agree to use an effective method of contraception during the trial exclusion criteria: * primary malignancies of the central nervous system(cns) or uncontrolled cns metastases * requirement of pharmacologic doses of glucocorticoids * prior treatment with chimeric antigen receptor t cells (car-t cells) * hiv positive; known active hepatitis b or c * known hypersensitivity to any of the components of prt543 * prior allogeneic bone marrow transplant; autologous hematopoietic transplantation less than 100 days since transplantation

Keywords: prmt5 prmt5 inhibitor
evaluation of the immunogenicity and safety of concomitant administration of novel oral polio type 2 vaccine and bivalent oral polio vaccine

Conditions: Poliomyelitis

Summary: the study will assess and compare the immune response and safety following the co-administration of novel oral polio type 2 (nopv2) and bivalent oral polio vaccine (bopv) in comparison with nopv2 or bopv in infants aged 2 months who have never received vaccination against poliomyelitis.


Eligibility criteria:
inclusion criteria: 1. infants aged 8 weeks (-1, + 2 weeks) with birth weight \>2,500 gm. 2. healthy infants without obvious medical conditions like immunodeficiency diseases, severe congenital malformations, severe neurological diseases or any other disease that require high doses of corticosteroids or immunotherapies that preclude the subject to be in the study as established by the medical history and physical examination. 3. written informed consent obtained from 1 or 2 parent(s) or legal guardian(s) as per country regulations. exclusion criteria: 1. infants who have received previous vaccination according to the national immunization program (nip) (i.e. vaccination against poliomyelitis and/or receipt of diphtheria-tetanus-whole cell pertussis-hepatitis b-haemophilus influenzae type b \[dtpw-hb-hib vaccine\]). 2. infants with anyone under 10 years of age in their household (living in the same house or apartment unit) who does not have complete "age appropriate" vaccination status with respect to poliovirus vaccines at the time of study vaccine administration according to the dominican republic nip. 3. infants having a member of their household (living in the same house or apartment unit) who is under 6 months of age at the moment of study vaccine administration. 4. infants having a member of their household (living in the same house or apartment unit) who has received oral polio vaccine (opv) in the previous 3 months before study vaccine administration. 5. any confirmed or suspected immunosuppressive or known immunodeficient condition including human immunodeficiency virus infection in the potential participant or any member of the subject's household. 6. family history of congenital or hereditary immunodeficiency. 7. major congenital defects or serious uncontrolled chronic illness (neurologic, pulmonary, gastrointestinal, hepatic, renal, or endocrine). 8. known allergy to any component of the study vaccines or to any antibiotics, that share molecular composition with the nopv2 vaccines. 9. administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. 10. acute severe febrile illness at day of vaccination deemed by the investigator to be a contraindication for vaccination (the child can be included at a later time if within age window and all inclusion criteria are met.). 11. subject who, in the opinion of the investigator, is unlikely to comply with the protocol or is inappropriate to be included in the study for the safety or the benefit-risk ratio of the subject.
kudzu treatment for alcohol abuse

Conditions: Alcohol Consumption

Summary: this is a study designed to test whether a single administration of kudzu extract (2 mg) will significantly reduce the number of drinks consumed during a single 1 ½ hours drinking session when given as pretreatment 2 ½ hours before the drinking session.

in a laboratory experimental setting, subjects will be treated with placebo or 2 grams of kudzu extract 2.5 hours before an afternoon drinking session. the investigators hypothesis is that the kudzu pretreatment will reduce alcohol consumption in this free choice, self-administration paradigm.

Eligibility criteria:
inclusion criteria: * capable of understanding and complying with the protocol * good physical and mental health (normal physical exam, ecg, blood and urine chemistries) * body mass index between 18-30, inclusive * age 21-40 years * moderate to heavy alcohol drinkers (on the average 20+ drinks/week) or a self-reported pattern of incidences of binge drinking 2 or more times per week (4 or more alcoholic beverages in one sitting) * have a stable living situation with current postal address exclusion criteria: * concurrent diagnosis of axis i disorder * current or past alcohol dependence; may meet criteria for alcohol abuse. other drug dependence acceptable only if greater than 3 years. * immediate family history pattern of alcoholism or problem drinking (parents or siblings) * current drug abuse (other than alcohol or marijuana abuse). past drug abuse is acceptable. * subjects cannot be actively seeking treatment for any drug or alcohol dependence. * subjects cannot use marijuana more than once a week. marijuana abuse/dependence are acceptable if the use criteria is met. * maintained on an antipsychotic or antidepressant medication; taking prescription medications except certain short-term anti fungal agents and some tropical creams for dermal conditions. * tobacco use greater than 5 cigarettes per day * history of major head trauma resulting in cognitive impairment or history of seizure disorder * heavy caffeine use (greater than 500 mg on a regular, daily basis) * subject has active hepatitis and/or aspartate aminotransferase (ast), alanine aminotransferase (alt) \> 3x the upper limit of normal * for female volunteers, a positive pregnancy test

Keywords: alcohol consumption kudzu extract
nadroparin versus tips in cirrhotic patients with refractory asymptomatic pvt

Conditions: Portal Vein Thrombosis

Summary: the purpose of this study is to evaluate the comparative effectiveness of nadroparin versus transjugular intrahepatic portosystemic shunt in cirrhotic patients with refractory asymptomatic portal vein thrombosis using a design of a multicenter, randomized controlled trial

this research project aims to investigate the efficacy and safety of anticoagulant therapy in patients with portal vein thrombosis (pvt) associated with liver cirrhosis. building upon this, a randomized controlled study will be carried out for pvt patients with poor response to anticoagulant treatment. the study will compare the effects of transjugular intrahepatic portosystemic shunt (tips) and prolonged anticoagulant therapy. the ultimate goal is to provide high-quality clinical research evidence for interventional treatment of liver cirrhosis-associated pvt. this comprehensive approach aims to provide evidence-based medical guidance for optimizing the treatment pathway for refractory pvt in liver cirrhosis.

Eligibility criteria:
inclusion criteria: * diagnosed with liver cirrhosis * diagnosis of portal vein thrombosis through computed tomographic venography with a thrombus diameter exceeding 30% of the vessel diameter. * consent to participate in the clinical trial and the signing of an informed consent form. exclusion criteria: * presence of acute symptoms such as fever, abdominal pain or bleeding, or of cavernous transformation * patients with child-pugh c. * pregnant or lactating women. * with a history of liver cancer or other malignancy. * severe heart, lung diseases, or significant renal dysfunction. * allergies to anticoagulant medications, uncontrolled hypertension, history of cerebral hemorrhage, discovery of gastrointestinal ulcers, ulcerative colitis, subacute bacterial endocarditis, or other contraindications to anticoagulant drugs. * on concomitant therapy of immunosuppressive drugs. * with coagulation disorders other than liver disease. * with active variceal bleeding.

Keywords: portal vein thrombosis liver cirrhosis nadroparin transjugular intrahepatic portosystemic shunt
psilocd: a pharmacological-challenge feasibility study

Conditions: Obsessive-Compulsive Disorder

Summary: the purpose of this study is to assess the impact of psilocybin on cognitive inflexibility and neural plasticity in a cohort of people with obsessive-compulsive disorder (ocd).

this mechanistic study will utilise a within-subjects design, administering up to 10mg of psilocybin to participants with ocd (dsm-5 criteria) on two separate instances spaced four weeks apart. to ensure consistency and participant safety, dosing will occur under medical supervision with psychological support from two experienced therapists. before and after each session, participants will engage in virtual preparation and integration sessions led by their therapists. cognitive tasks will be administered in the days following each dosing session. additionally, acute post-dosing eeg recordings will be conducted, and blood samples will be taken after each dosing session. ocd symptoms will also be assessed seven times throughout the trial by an external blinded psychiatrist, serving as a secondary outcome. collectively, these measures aim to evaluate changes in cognitive inflexibility, decision-making abilities, neuroplasticity (peripheral blood markers and eeg measures), inflammation (peripheral blood markers), and symptomatology following each dosing session.

Eligibility criteria:
key inclusion criteria: * aged 20 to 65 years; * any gender; * a primary diagnosis of ocd (based on the mini-international neuropsychiatric interview (m.i.n.i.)); * has met diagnostic criteria for ocd for at least 12 months; * willing to comply with protocol and associated lifestyle restrictions; * adequate understanding of the english language to give informed consent and participate in the study; * participant can attend visits as an outpatient; * comfortable using a computer, access to internet from home, and willing to participate in some of the study visits via video-link. key exclusion criteria: * current or past history of dependent (according to icd10 criteria) substance use (not including nicotine and/or caffeine), tourette's syndrome, autism spectrum disorder, epilepsy, organic mental disorder, or a personality disorder apart from obsessive-compulsive personality disorder; * current or past history of psychosis or mania in themselves or a first-degree relative; * unstable physical health; * significantly abnormal clinical test result; * heavy smoker, or unable to attend the dosing days (including the subsequent recovery part) without a smoking break; * unwillingness to allow their gp or mental health practitioners to be informed of their participation (or, to allow study team access to summary care record).
postoperative concurrent chemoradiotherapy versus radiotherapy alone for patients with locoregionally advanced esophageal squamous cell carcinoma

Conditions: Esophageal Squamous Cell Carcinoma

Summary: the aim of this study is to investigate the effect of postoperative concurrent chemoradiotherapy versus radiotherapy alone for patients with locally advanced esophageal squamous cell carcinoma.


Eligibility criteria:
inclusion criteria: 1. biopsy-confirmed esophageal squamous cell carcinoma 2. age ≤ 70 years old, 3. karnofsky performance status ≥ 70, 4. r0 esophagectomy according to the pathological examination of the resected specimens, 5. postoperative stage ⅱ-ⅳa according to the ajcc 7th edition of tumor-node-metastasis (tnm) classification for esophageal carcinoma 6. adequate organ functions (1).white blood cell (wbc) ≥3×109⁄l; (2).absolute neutrophil counts (anc) ≥1.5×109⁄l; (3).hemoglobin (hb) ≥10g⁄dl; (4).platelet (plt) ≥100×109⁄l; (5).total bilirubin \ 0.8 l;. 7. no previous treatment or severe complications 8. written informed consent exclusion criteria: 1. previous treatment with chemotherapy or radiotherapy 2. greater than 3 months after surgery 3. complete esophageal obstruction after surgery, esophageal perforation; 4. other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived with no evidence disease for over 3 years; 5. pregnant or breast-feeding women； 6. patients with any serious concurrent disease, such as severe diabetes, uncontrolled hypertension, serious chronic obstructive pulmonary disease； 7. drug addiction, alcoholism or aids; 8. uncontrolled seizures or psychiatric diseases, loss of control over their own behavior; 9. with clear chemotherapy drug allergy 10. participation in other interventional clinical trials within 30 days;

Keywords: esophageal neoplasma adjuvant therapy chemotherapy radiotherapy