Kornimate/medical-research-clean huggingface dataset:
use of a novel drug in people with non-alcoholic steatohepatitis (nash) or non-alcoholic fatty liver disease (nafld)

Conditions: Non-alcoholic Fatty Liver Disease (NAFLD); Non-alcoholic Steatohepatitis (NASH)

Summary: does the novel drug decrease liver fat in subjects with nash or nafld as compared to placebo

we propose to evaluate hepatic fat and hepatic fibrosis using magnetic resonance elastography (mre) liver (pre vs. post). we will also establish glucose tolerance status by our established labeled oral glucose tolerance test (ogtt) (6,6 ²h2 glucose). following baseline evaluation subjects with biopsy/mre proven nash will be randomized to one of two groups and treated either with active drug (az compound) or placebo for 12 weeks (plus or minus 1 week). subjects with history suggestive of non-alcoholic fatty liver disease (nafld) or nash will be invited to participate. if they meet criteria following initial screening they will be included in the study. ogtt, liver mre will be repeated. liver enzymes \[aspartate aminotransferase (ast), alanine aminotransferase (alt),alkaline phosphatase (alp)\] as well as other safety tests \[creatine phosphokinase (cpk), thyroid stimulating hormone (tsh), international normalized ratio (inr),total bilirubin\] will be measured before, monthly during therapy and at one month following therapy. furthermore, we will also do the subgroup analysis in nash/nafld subjects with and without diabetes to see the effect of the drug.

Eligibility criteria:
inclusion criteria: * age: 21-75 * body mass index (bmi) \>19 kg/m\^2 * subjects with biopsy/mre proven nash \[mre liver fat ≥ 5%, with elevated liver enzymes alt \<5x upper limit normal (uln)\]. * subjects with nafld and mre shows f0 or greater fibrosis * subjects with history suggestive of nafld/nash * total bilirubin must be \< 1.5 x uln and inr must be \< 1.3 at baseline screening. * tsh and cpk will be within normal limits (wnl) at screening. * subjects with type 2 diabetes who are on stable doses of medications (except pioglitazone) to control hyperglycemia and have baseline hba1c of 10% or lower. * hemoglobin must be greater than or equal to 12.0 in males and 11.0 in females. exclusion criteria: * medications that may affect glucose metabolism such as corticosteroids, opiates, barbiturates, and anticoagulants. * subjects with anemia, and symptoms suggestive of undiagnosed illness, overt hepatic disease, stroke, alzheimer's disease, autoimmune hepatitis, alcoholism or increased alcohol consumption over the american diabetes association (ada) guidelines. * any disorder that may potentially impact the outcome measures. * pregnant women and children. * subjects planning weight loss or in any weight loss program. * subjects taking tzd's, atazanavir, indinavir, ketoconazole, valproic acid, silybum marianum and valeriana officinalis.
ranibizumab treatment for retinal vein occlusion

Conditions: Macular Edema Due to BRVO/CRVO

Summary: in retinal vein occlusion, predictive factors for visual outcome after ranibizumab treatment have not been evaluated comprehensively. therefore, we have planned to analyze predictors for visual outcome from a viewpoint of electrophysiology and biomarkers besides morphological features by sd-oct.


Eligibility criteria:
inclusion criteria: * signed informed consent form * male or female of aged 18 years or older * macula edema secondary to brvo/crvo * decrease of va due to macular edema exclusion criteria: * prior episode of rvo * previous treatment with anti-vegf drugs or corticosteroid or grid laser photocoagulation (study eye) * ocular disorders in the study eye that may confound interpretation of study results * history of vitrectomy surgery, submacular surgery, or other surgical intervention for rvo * the pregnant or lactating woman
ace393-103 vaccination challenge study

Conditions: Campylobacter Infection

Summary: the purpose of this study is to determine whether ace393 vaccination can protect against campylobacteriosis in a challenge model.

this study is a randomized, double blind, parallel group, placebo controlled study, in which subjects, with no evidence of prior c.jejuni infections or immunity, will be vaccinated with ace393, a protein sub-unit vaccine, or placebo, and then subsequently challenged with c.jejuni. the study will include vaccination of approximately 72 subjects, with the aim of challenging a total of 60 subjects. ace393 or placebo will be administered twice by intramuscular injection on an outpatient basis, three weeks apart and then the subjects will be challenged three weeks later with c.jejuni. during the inpatient monitoring period, volunteers will be evaluated daily for safety, clinical signs and symptoms of disease and stool microbiology). criteria for early institution of oral hydration, intravenous fluids, serum electrolyte monitoring, blood cultures, and/or antibiotics are predefined. all volunteers will receive antibiotic therapy 6 days after challenge (unless treated early). discharge criteria are predefined. post-discharge follow-up will further monitor safety, confirm c .jejuni eradication after antibiotic therapy, and assess immunologic response.

Eligibility criteria:
inclusion criteria (selected): * male or female between 18 and 50 years of age. * general good health, without significant medical illness, abnormal physical examination findings or clinical laboratory abnormalities as determined by the principal investigator or the principal investigator in consultation with the medical monitor and sponsor. * negative serum pregnancy test at screening. exclusion criteria (selected): * immunosuppressive illness or clinically significant iga deficiency. * positive serology results for hiv, hbsag, or hcv antibodies. * evidence of inflammatory arthritis on examination and/or hla-b27 positive. * allergy or prior intolerance to selected antibiotics (specified in the protocol) * fewer than 3 stools per week or more than 3 stools per day as the usual frequency; or passing of loose or liquid stools other than on an occasional basis. * history of diarrhea. * stool culture positive for campylobacter, other bacterial enteropathogens and intestinal parasites. * history of microbiologically confirmed campylobacter infection. * history of vaccination for or ingestion of campylobacter. * immunologic evidence of campylobacter exposure * serologic evidence of prior campylobacter infection. * cell mediated immune response evidence of prior campylobacter infection. * fever within 48 hours preceding challenge. * presence of any signs or symptoms indicative of active infection. * diarrhea occurring in the 7 days prior to challenge. * stool culture positive for campylobacter, other bacterial enteric pathogens or intestinal parasites.

Keywords: vaccination diarrhea traveler's diarrhea campylobacter jejuni c. jejuni campylobacter campy
methotrexate in metastatic colorectal cancer with msh2 deficiency

Conditions: Advanced Colorectal Cancer

Summary: to assess the efficacy of methotrexate in a genetically selected population of patients with advanced colorectal cancer, who have loss of a particular gene, msh2. the efficacy of methotrexate will be evaluated by the proportion of cases that have a significant response to treatment (objective response rate).

the study will involve treating 29 subjects with methotrexate given intravenously. all subjects will receive treatment; there is no control arm or randomisation. the subjects will be known to have deficiency of msh2, or a mutation (genetic change) in msh2 that stops it functioning normally. this can either be demonstrated by testing for loss of msh2 protein in the tumour itself, or by the demonstration of a mutation in the msh2 gene in the subject's blood.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of metastatic or locally recurrent colorectal carcinoma * aged 18 years or older * paraffin embedded histological material available for analysis * either confirmed loss of expression of msh2 on immunohistochemistry ihc or confirmed mutation in msh2 on gene sequencing * life expectancy of \> 3 months exclusion criteria: * previous treatment with methotrexate, either for malignant or non-malignant disease, except when methotrexate was given at low dose with other drugs to modify their effects * concomitant uncontrolled medical conditions * concomitant metastatic malignancy apart from non-melanotic skin cancers and carcinoma in situ of the uterine cervix in the last 10 years * any contraindication to treatment with methotrexate (as this will affect safety)

Keywords: colorectal cancer msh2 metastatic
dose determining study of exs73565 in participants with relapsed or refractory b-cell malignancies

Conditions: Relapsed or Refractory B-cell Malignancies

Summary: the purpose of this study is to characterize the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of exs73565 administered orally as a single agent in participants with relapsed/refractory b-cell malignancies.


Eligibility criteria:
key inclusion criteria: * age ≥18 years at the time of signing the informed consent. * eastern cooperative oncology group (ecog) performance status of 0-1. * histologically confirmed diagnosis of one of the following b-cell malignancies: chronic lymphocytic leukemia (cll), including richter's transformation from cll, mantle-cell lymphoma, diffuse large b-cell lymphoma, follicular lymphoma, or marginal zone lymphoma. * participants that have relapsed after standard of care or have progressed during standard of care or are not suitable for standard of care therapy key exclusion criteria: * any medical or psychiatric condition that, in the view of the principal investigator, could jeopardize or would compromise the participant's safety or ability to participate in the study. * known central nervous system (cns) malignancy or primary cns lymphoma. * concurrent active or previous malignancy (other than the primary lymphoma/cll for which the participant will be treated on this protocol within 5 years prior to randomization; participants with prior cancers may be enrolled with documented sponsor approval. * received anticancer therapy, including chemotherapy, immunotherapy, radiation therapy (with the exception of palliative radiotherapy), biologic therapy, cancer-related hormonal therapy, or any investigational therapy within 21 days or 5 half-lives (whichever is longer) before the first dose of the study treatment.
high resolution manometry after partial fundoplication for gastro-oesophageal reflux

Conditions: Gastroesophageal Reflux; Esophageal Motility Disorders; Upper Gastrointestinal Disorder

Summary: this is a combined retro- and prospective, monocentric study. all patients who underwent or are planned for laparoscopic partial fundoplication (180° anterior or 270° posterior) between 2020-2023 are assessed for preoperative ineffective esophageal motility (iem). the main hypothesis is, that preoperative oesophageal motility disorders, especially hypo-contractility or failed peristalsis, are caused by gastro-oesophageal reflux. therefore, postoperative manometry after partial wrap fundoplication (270° posterior, 180° anterior) shows a decrease in comparison to preoperative motility disorders. the primary objective of this study is to examine the postoperative esophageal motility in patients with known preoperative motility disorders. secondary endpoints are the presence of other oesophageal motility disorders pre- vs. postoperatively (including new onset disorders), the assessment of the gastrointestinal symptom rating scale (gsrs) pre- vs. postoperatively, and more. if iem is present preoperatively, patients are contacted at least 1 year after surgery and will be informed about the study and asked to participate. in case of agreement, they are invited to the study site. they undergo high-resolution manometry 18-24 months postoperatively (study intervention).


Eligibility criteria:
inclusion criteria: * age older than 18 years * ineffective esophageal motility disorder according the chicago classification (7), defined as ≥ 7/10 (70%) of swallows with weak contraction (distal contraction interval (dci) between 100mmhg/s/cm and less than 450 mmhg/s/cm) or ≥ 5/10 (50%) of swallows with failed peristalsis (dci \<100mghg/s/cm)performance of partial fundoplication (180° anterior or 270° posterior) at spital limmattal * informed consent as documented by signature exclusion criteria: * age under 18 years * pregnancy * normal preoperative esophageal motility * other specifically defined esophageal motility disorders such as nutcracker or jackhammer esophagus * preoperative presence of a hiatal hernia with migration of \>20% of stomach in the chest * revisional surgery (after other procedures for reflux or at the hiatus)
safety and tolerability study of cogane™ in healthy volunteers and parkinson's disease patients

Conditions: Parkinson's Disease

Summary: phytopharm plc is developing cogane™ which is a new medicine for the treatment of parkinson's disease (pd). the purpose of the study is to find out if cogane is safe and well tolerated in both healthy volunteers and parkinson's disease patients and to determine if there is a difference in the way that the body deals with cogane (pharmacokinetics) between these two groups. it is expected that the study will prove that cogane™ is safe and well tolerated and will provide us with a pharmacokinetic profile for both subject groups.


Eligibility criteria:
key inclusion criteria (healthy volunteers): * male \& female healthy volunteers aged between 40 and 80 years at the time of informed consent * females of non-childbearing potential * general good health key exclusion criteria (healthy volunteers): * no clinically significant and relevant medical history * smoked within the 3 months prior to screening * use of prescription or non-prescription systemic or topical medication (including herbal remedies) within 14 days of the first dose administration key inclusion criteria (parkinson's disease patients): * male \& female parkinson's disease patients aged between 40 and 80 years at the time of informed consent * must have a diagnosis of idiopathic parkinson's disease according to the uk parkinson's disease society brain bank criteria * subjects who are taking parkinson's disease treatments should be on a stable regimen for at least 4 weeks prior to screening key exclusion criteria (parkinson's disease patients): * diagnosis of dementia * parkinson's disease of a known genetic cause * history of surgical intervention for parkinson's disease

Keywords: parkinson's disease phase i
effects of deep brain stimulation of the dentate nucleus on cerebellar ataxia

Conditions: Cerebellar Ataxia

Summary: cerebellar ataxias are a group of disorders caused by cerebellar affections, for which currently no specific treatment is available. some limited studies verified the effects of cerebellar transcranial magnetic stimulation (tms) on ataxic symptoms, with good results. the hypothesis is that cerebellar tms could improve ataxic symptoms in some patients and in these patients, chronic cerebellar stimulation through deep brain stimulation could be a therapeutic option. the rationale is to stimulate the dentate nucleus of the cerebellum in order to balance the functional asymmetry observed between both motor cortices after chronic cerebellar lesions.

ten patients with cerebellar ataxia will be included in our protocol. ataxia might be due to several aetiologies, from degenerative to genetic and vascular diseases. the initial focus is vascular and spinal cerebellar ataxias. the participants will be submitted to a neuronavigation protocol for the precise location of the dentate nucleus contralateral to the most symptomatic side. after that, the participants will be randomly assigned to 5 active or 5 placebo sessions of 1hz tms over the located area. after the first 5 sessions and a period of at least 4 weeks washout, the participants will cross over and receive other 5 sessions, active or sham. clinical and video evaluations will be conducted before and after active and sham cluster of sessions. the good responders, i.e., with over than 30% of improvement after the active section will be eligible to bilateral dentate nucleus dbs. after that, again, a cross-over double blind on-off stimulation will be performed. each period (on or 0ff-stimulation) will last 4 weeks.

Eligibility criteria:
inclusion criteria: 1. patients with diagnosis of chronic cerebellar ataxia (\> 6 months); 2. age ≥18 years; 3. be able to understand study protocol; 4. signed, written informed consent (approved by the institutional ethics committee) obtained prior to any study procedure; 5. refractory symptoms response to first, second and third line pharmacological treatment; 6. daily living activities impaired because the ataxia; 7. be able to undergo surgery procedures. exclusion criteria: 1. abuse of alcohol, drugs 2. known psychiatric conditions 3. contraindications to dbs 4. heart failure or cardiac disease that contraindicates surgery procedures; 5. pacemaker or other stimulators implanted active; 6. positive blood ß-hcg test for women; 7. other medical conditions demand hospitalization; participation in other clinical studies at the same time;

Keywords: cerebellar ataxia stroke spinocerebellar ataxia deep brain stimulation dentate nucleus
open trial of a program to support parents of children with attention-deficit/hyperactivity disorder (adhd)

Conditions: ADHD

Summary: behavioral parent training is an evidence-based treatment for adhd. the intervention can be implemented individually, or in groups. currently, group-based parent training programs require considerable coordination, including ascertainment of a large physical space, the coordination of all families traveling to the same location at the same time, and the require for the provision of childcare. innovations in online connectivity and ease of implementation of online support applications (e.g., zoom) may reduce these barriers. however, it is necessary to investigate the feasibility and promise of the online approach to ensure it supports parents effectively.

this study will utilize a pre-post, open trial design as the primary aim is to investigate feasibility. approximately sixty parents will complete prepost ratings of parenting behaviors and measures of child functioning. they will also complete post treatment measures of satisfaction and open-ended questions about feasibility and suggestions for future iterations of the approach. process measures will include data collection related to attendance and engagement in the activities. risks include breach of confidentiality and a lack of effectiveness of the intervention for the child's presenting problems. benefits include the parent receiving an effective intervention.

Eligibility criteria:
inclusion criteria: * adhd diagnosis * intelligence quotient (iq) greater than or equal to 70 * at least 1 parent/guardian who can attend zoom sessions * access to reliable internet connection for zoom meetings exclusion criteria: * evidence of psychosis, suicidal behaviors, or autism level 2/3
pharmacokinetic of intravenous iron sucrose in adolescents on hemodialysis or peritoneal dialysis receiving epoetin

Conditions: Anemia

Summary: this is an open-label, multicenter pharmacokinetic study of hemodialysis (hd) or peritoneal dialysis (pd) patients receiving erythropoietin. patients were administered 100mg of iron sucrose undiluted by slow iv push over 5 minutes. patients underwent serial blood draws and were subsequently followed for 7 days for safety endpoints.

this is an open-label, multicenter pharmacokinetic study of hd of adolescent pd patients receiving erythropoietin. patients between the ages of 12 and 18 were administered 100mg of iron sucrose, undiluted by slow iv push over 5 minutes, and underwent serial blood draws. the patients were subsequently followed for 7 days for safety endpoints.

Eligibility criteria:
inclusion criteria: * age between 12 and 18 years * history of chronic renal failure requiring hd or pd * hgb \</= 13 g/dl * ferritin \< 800 ng/ml * transferrin saturation (tsat) \< 50% * receiving epoetin exclusion criteria: * known sensitivity to iron sucrose * severe concomitant disease of the liver or cardiovascular system * serious bacterial infection * pregnancy / lactation * active hepatitis * patients with causes of iron deficiency other that chronic renal failure * blood transfusion * body weight \< 25 kilograms * currently being treated for asthma * received investigational drug within last 30 days

Keywords: anemia pharmacokinetics
effect of hyperbaric oxygen therapy on cerebral palsy

Conditions: Cerebral Palsy; Hyperbaric Oxygen Therapy

Summary: abnormal gait is a common issue in children with cp. as a result of motor weakness and a lack of voluntary motor control. furthermore, gait in children with cerebral palsy is characterized by a slower walking speed, a shorter stride length, and more time spent in double support. deficits in postural control constitute a major limitation to the motor development in children with cp. the performance of static and dynamic tasks, such as sitting, standing, and walking, is limited in these children due to postural instability. postural control deficits in cp are caused by altered sensory processing, motor impairment, and biomechanical alignment, which result in altered neuromuscular responses. hbo2 therapeutic benefits in cp are attributed to an increase in dissolved oxygen in plasma and tissue, which aids tissue regeneration, so, the purpose of this study was to investigate the long-term effects of hyperbaric oxygen therapy on spatiotemporal gait parameters and functional balance skills in children with cp.

this was a randomized clinical trial. thirty-nine children with spastic cerebral palsy with ages ranging from 5 to 10 years referred from local pediatric rehabilitation centers participated in this study. all children were classified randomly using sealed envelopes into two groups (control and study groups). the children in the control group received traditional physical therapy and the study group received the same traditional physical therapy in addition to hyperbaric oxygen therapy. written informed consent from the child's legal guardian was obtained. the study was authorized by the ethics committee for research at cairo university in accordance with the ethical standards of the declaration of helsinki. pbs was used to assess functional balance and gaitrite was used to assess spatiotemporal gait parameters. measurements of functional balance and spatiotemporal gait parameters were taken three times: at the start of the intervention, eight weeks later, and six months after cessation of hpo2 therapy to assess the long-term effect.

Eligibility criteria:
inclusion criteria: * medically free by their doctor. * being able to tolerate a hyperbaric oxygen hood. * being able to blow through a straw, or swallow on command. * having spasticity ranging from 1 to 1+ on the modified ashworth scale * level i or ii on the gross motor function classification system (gmfcs). * being capable of understanding and following instructions exclusion criteria: * previous hbo treatments. * botulinum toxin a treatments. * thoracic surgery within 6 months. * major changes to spasticity medications within 3 months. * unstable epilepsy. * pulmonary dysfunction. * cardiovascular disease

Keywords: spastic cerebral palsy hyperbaric oxygen therapy functional balance gait parameters