Kornimate/medical-research-clean huggingface dataset:
rifaximin-treatment of collagenous colitis

Conditions: Collagenous Colitis

Summary: the hypothesis of this study is that an altered gut microbiota is a contributory factor in initiating an inflammatory process in the colonic mucosa leading to collagenous colitis. the investigators suggest that treatment with budesonide reduces the inflammation without treating the underlying cause. in this trial the investigators will try to modullate gut microbiota by adding rifaximin. the aim of this study is to assess if 4 weeks treatment with rifaximin as a supplement to a standard course of budesonide against active cc can reduce the risk of relapse after treatment cessation.

patients with biopsy-verified cc and active disease defined by \>3 bowel movements/day or \>1 watery stool measured as a mean for a week. patients will be invited to participate in the study independently of age and disease duration.

Eligibility criteria:
inclusion criteria: * • signed informed consent * histological findings fulfill criteria for cc: * a subepithelial collagenous band \>10 μm in colonic biopsies * increased count of inflammatory cells in lamina propria * diagnostic biopsies are a maximum of two years old * a history of nonbloody, watery diarrhea for more than two weeks prior to screening in patients with recently diagnosed cc or a history of clinical relapse for more than a week in patients with known cc * active disease: \> 3 stools/day or \>1 watery stool/day measured as a mean during a week prior to baseline exclusion criteria: * - significant findings at colonoscopy that could cause diarrhea (colonic diverticulosis and polyps \< 2 cm are not considered significant findings) * biopsies more than two years old in a patient, who does not accept a new sigmoidoscopy * untreated celiac disease * positive stool cultures for pathogenic intestinal bacteria including clostridium difficile * suspected colitis induced by medication (diarrhea shortly after commencement of nsaid's, statins, ssri or ppi) * severe comorbidity (cardiovascular, renal, endocrine, neurologic, pulmonal or psychiatric) or history of cancer during the last 5 years * abnormal liver biochemistry (alat or alp \> 2,5 x upper limit), cirrhosis or portal hypertension * pregnancy or lactation (assured by negative p-hcg at inclusion) * history of significant intestinal resection * treatment with 5-asa, salazopyrin, immunemudulators (azathioprine, 6-mercaptopurine or methotrexate), biologic drugs (tnf-alfa-inhibitors), local or systemic glucocorticoids (except for budesonide) within the last three month * allergy or intolerance to rifaximin (or similar antibiotics such as rifampicin or rifabutin) * expectation of lack of cooperation or insufficient comprehension * concomitant participation in an other clinical trial or participation within the last 30 days * patients receiving warfarin or marcoumar (interaction with risk of uncontrolled inr-levels)

Keywords: microscopic colitis diarrhoea microbiome rifaxamine
a 6-month extension study to assess the long-term safety of engensis in amyotrophic lateral sclerosis

Conditions: Amyotrophic Lateral Sclerosis

Summary: the purpose of this study is to evaluate the long-term safety of intramuscular administration of engensis in participants with amyotrophic lateral sclerosis who were previously randomized, received treatment, and completed the day 180 visit of study vmals-002-2. safety will be assessed by incidences of treatment-emergent adverse events, treatment emergent serious adverse events, adverse events of special interest, and the clinically significant laboratory values.

vmals-002-2b was a safety extension study following vmals-002-2, which was a phase 2a, double-blind, randomized, placebo-controlled, multicenter study designed to assess the safety of intramuscular administration of engensis in subjects with amyotrophic lateral sclerosis.following completion of the day 180 visit in vmals-002-2 and signing of written informed consent, subjects were enrolled in this approximately 180-day extension study, with subjects completing combined participation with a day 365 visit. assessments to be conducted during this extension study were as follows: vital signs, weight and height, complete physical examination, 12-lead electrocardiogram, a record of all concomitant medications and procedures, clinical laboratory assessments, revised amyotrophic lateral sclerosis functional rating scale, handheld dynamometry, slow vital capacity, amyotrophic lateral sclerosis assessment questionnaire, 40 questions, patient global impression of change, and clinical global impression of change. assessments of treatment-emergent adverse events, treatment-emergent serious adverse events, adverse events of special interest, and clinically significant laboratory values continued from the day 180 visit of study vmals-002-2 through the vmals-002-2b extension study to day 365.

Eligibility criteria:
inclusion criteria: * participants who complete the day 180 visit in vmals-002-2 are eligible to enroll in this extension study, vmals-002-2b. exclusion criteria: - none
the role of high density surface ecg in the diagnosis of arrhythmogenic right ventricular cardiomyopathy (arvc)

Conditions: Arrhythmogenic Right Ventricular Cardiomyopathy

Summary: the diagnosis of arrhythmogenic right ventricular cardiomyopathy can be difficult. the 80 lead ecg may increase the specificity and sensitivity in diagnosing this potentially life threatening inherited cardiac condition. this pilot would form the basis of a much larger clinical trial to test the utility of this novel diagnostic tool.


Eligibility criteria:
inclusion criteria: * patients with a confirmed diagnosis of arrhythmogenic right ventricular cardiomyopathy who are being followed up in the cardiology clinic exclusion criteria: * inability to consent * pacing dependent patients * other concomitant cardiag disease e.g. coronary artery disease * atrial fibrillation
bupropion in the treatment of pathological gambling

Conditions: Pathological Gambling

Summary: this study will determine whether the drug bupropion is an effective treatment for pathological gambling.

as gambling opportunities proliferate, pg has become a major health concern. despite its importance, few treatment options with proven efficacy exist. this study will attempt to identify an effective treatment for pg. participants are randomly assigned to receive either bupropion or placebo for 12 weeks. participants are assessed at baseline and at weeks 2, 3, 4, 5, 6, 8, 10, and 12. self administered questionnaires and interviews are used to assess participants. follow-up assessments are made 1, 3, and 6 months after study completion.

Eligibility criteria:
inclusion criteria: * meet the criteria for pathological gambling (dsm-iv-tr), through the administration of the national opinion research center dsm screen for gambling problems(nods); * meet the criteria for pathological gambling (dsm-iv-tr), through the administration of the national opinion research center dsm screen for gambling problems(nods); * receive a score of 5 or more on the south oaks gambling screen (sogs); * have pg for at least one year; * have had at least 2 or more gambling episodes during the 2-week screening period; * speak standard english; * be able to give written informed consent. exclusion criteria: * evidence of current (past 3 months) substance misuse; * had a hamilton depression rating scale (hdrs)27 score of 18 or more (or a score on item 1 of greater than 2; * had a current eating disorder (except binge eating disorder); * had any history of seizures, or suicidal or aggressive behavior; * had a urine drug screen positive for stimulants, opiates, hallucinogens, or phencyclidine; * had a current or past psychotic disorder, bipolar disorder, or significant cognitive disorder; * received monoamine oxidase inhibitors within 3 weeks of randomization, long acting phenothiazine within 3 months of randomization,fluoxetine within 4 weeks of randomization, or other psychotropic drugs within 2 weeks of randomization; * had prior exposure to bupropion; * were engaged in individual, group, or couples psychotherapy during the 2 weeks before randomization, (except gamblers anonymous).
differential diagnosis of cognitive disorders of psychiatric or neurodegenerative origin

Conditions: Neurocognitive Disorders

Summary: the aim of the research is to analyze whether 18f-fdg pet helps in the diagnosis and therefore in the management of the patient.

neurocognitive disorder or mild cognitive impairment corresponds to a decline in one or more cognitive functions; compared to the previous level of performance. indeed, the prevalence of neurodegenerative pathologies is estimated at more than one million according to santé publique france, due to the aging of the population. to be compared with the prevalence of the population suffering from a psychiatric disorder estimated at one in five people, or 13 million french people, in 2021. with the increase in the prevalence of these two entities and their clinical entanglement, the question arises of the origin of neurocognitive disorders, is it a manifestation of a psychiatric pathology or a neurodegenerative pathology not yet diagnosed. if this is the case, the patient's prognosis is modified with a pejorative evolution and a loss of autonomy which is to be anticipated. this delay deprives the patient and his family of interventions likely to alleviate behavioral disorders; maintain a level of autonomy compatible with life at home; alleviates the burden and improves the quality of life of caregivers.

Eligibility criteria:
inclusion criteria: * adult patients with cognitive impairment * positron emission tomography with flurodeoxyglucose labeled with fluorine 18 carried out in the course of care exclusion criteria: * patients objecting to the collection of their data
memantine for executive dysfunction in adults with adhd: a pilot study

Conditions: Attention Deficit Hyperactivity Disorder (ADHD); Executive Function Deficits (EFD)

Summary: this is a 12-week clinical trial evaluating the efficacy and safety of memantine hydrochloride (namenda) in the treatment of executive function deficits (efds) in adults with attention deficit hyperactivity disorder (adhd) receiving open-label treatment with oros-methylphenidate (oros-mph, concerta). the study aims to examine the effects of treatment with memantine on adhd symptoms. following screening procedures, memantine is prescribed in randomized, double-blind fashion (equal chance of medication or placebo) for 12 weeks, along with open-label oros-mph (everyone receives medication).


Eligibility criteria:
inclusion criteria: 1. male or female adults ages 18-50 years 2. a diagnosis of childhood onset adhd, according to the diagnostic and statistical manual of mental disorder, fourth edition (dsm-iv) based on clinical assessment 3. a score of 20 or more on the adult adhd investigator symptom report scale (aisrs) 4. efds as established by at least 2 abnormal (\>65) subscales of brief-a exclusion criteria: 1. a history of non-response or intolerance to methylphenidate at adequate doses as determined by the clinician 2. a history of non-response or intolerance to memantine at adequate doses as determined by the clinician 3. pregnant or nursing females 4. a history of clinically unstable or significant other psychiatric conditions including suicidality, homicidality, bipolar disorder, psychosis, or current tic disorder, as judged by the clinician 5. history of narrow angle glaucoma 6. current (within 3 months) dsm-iv criteria for substance abuse or dependence 7. medical condition or treatment that will either jeopardize subject safety or affect the scientific merit of the study, including cardiovascular disease, hypertension, history of renal or hepatic impairment, organic brain disorders, or history of seizure disorder. 8. abnormal hematological or metabolic parameters 9. iq \< 80 10. current use of any psychotropic medication 11. lack of facility with the english language 12. investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild

Keywords: adhd executive function namenda concerta
effect of phonophoresis with vitamin b12 on cts

Conditions: Carpal Tunnel Syndrome

Summary: the purpose of this study is to investigate efficacy of phonophoresis with vitamin b12 on median nerve distal latency, pain level and hand grip strength in patients with carpal tunnel syndrome. at least fifty four patients from both sexes will be recruited for this study from various hospitals in 6th october city * group a (n = 27): will receive phonophoresis with vitamin b12 gel. * group b (n = 27): will receive placebo phonophoresis with vitamin b12 gel. median nerve distal latency, hand grip strength and numerical pain rating scale will be measured at baseline and after 3 weeks.


Eligibility criteria:
inclusion criteria: 1. at least fifty four patients with mild to moderate cts. 2. age will range between 18 to 60 years old. 3. all patients will have body mass index between 18.5 and 29.9 kg/m2. 4. diagnosed by a physician according to american association of electrodiagnostic recent guidelines. (jablecki et al., 2002). 5. a positive clinical provocative tests for cts (tinel test and phalen test), 6. patients with history of pain, paresthesia or numbness in the median nerve distribution, nocturnal pain, and night waking. exclusion criteria: 1. diabetic patients. 2. hypertension patients. 3. pregnant women 4. cardiovascular patients 5. patients with cervical spondylosis 6. patients with cervical disc prolapse 7. patients with thoracic outlet syndrome 8. patients with carpal tunnel release surgery
inhaled ondansetron & dyspnea

Conditions: Dyspnea

Summary: "dyspnea" refers to the awareness of breathing discomfort that is typically experienced during exercise in health and disease. in various participant populations, dyspnea is a predictor of disability and death; and contributes to exercise intolerance and an adverse health-related quality-of-life. it follows that alleviating dyspnea and improving exercise tolerance are among the principal goals of disease management. nevertheless, the effective management of dyspnea and activity-limitation remains an elusive goal for many healthcare providers and current strategies aimed at reversing the underlying chronic disease are only partially successful in this regard. thus, research aimed at identifying dyspnea-specific medications to complement existing therapies for the management of exertional symptoms is timely and clinically relevant. the purpose of this study is to test the hypothesis that single-dose inhalation of nebulized ondansetron (a serotonin 5-ht3 receptor antagonist) will improve the perception of dyspnea during strenuous exercise in health, young men. to this end, the investigators will compare the effects of inhaled 0.9% saline placebo and inhaled ondansetron (8 mg) on detailed assessments of neural respiratory drive (diaphragm emg), ventilation, breathing pattern, dynamic operating lung volumes, contractile respiratory muscle function, cardio-metabolic function and dyspnea (sensory intensity and affective responses) during symptom-limited, high-intensity, constant-work-rate cycle exercise testing in healthy, men aged 20-40 years.


Eligibility criteria:
inclusion criteria: * male * aged 20-40 years * fev1 ≥80% predicted * fev1/fvc \>70% exclusion criteria: * current or ex-smoker * body mass index \ 30 kg/m2 * history of cardiovascular, vascular, respiratory, renal, liver, musculoskeletal, endocrine, neuromuscular and/or metabolic disease/dysfunction. * taking doctor prescribed medications * allergy to latex * allergy to lidocaine or its "caine" derivatives

Keywords: ondansetron exercise
study of arimidex and radiotherapy sequencing

Conditions: Breast Cancer

Summary: the purpose of this study is to compare tgf-β1 change in concomitant with that in sequential arimidex in postmenopausal women with breast cancer, as measured by the proportion of patients with an elevation of tgf-β1 level at the 4th week after initiation of radiotherapy relative to the pre-treatment baseline.


Eligibility criteria:
inclusion criteria: * provision of informed consent * pathological confirmation of breast cancer * er(+) and/or pr(+). * post-menopausal woman * age≤70 years old * breast conservative surgery with axillary dissection or staging by either sentinel nodes biopsy or axillary sampling * post-mastectomy patients with t1-t2 and n1-n3, or t3-t4 with any n negative surgical margins * karnofsky≥70 * laboratory criteria: * plt≥100\*109/l * wbc≥4000/mm3 * hgb≥10g/dl * alt and ast\<2\*uln * no presence of metastatic disease * no other malignant tumour exclusion criteria: * presence of metastatic disease. * t1, t2, n0 with mastectomy * non-infiltrative breast carcinoma underwent mastectomy * other malignant tumor (concurrent or previous). * positive surgical margins. * patients with demonstrated hypersensitivity to arimidex or any excipient. * patients with severe renal impairment (creatinine clearance less than 20 ml/min). * patients with moderate or severe hepatic disease. * oestrogen-containing therapies should not be co-administered with arimidex as they would negate its pharmacological action. * not able or willing to sign informed consent * autoimmune diseases including scleroderma, systemic lupus erythematosus and so on

Keywords: breast cancer timing of radiotherapy tgf-beta1
a study to evaluate the effectiveness, tolerability and safety of laquinimod

Conditions: Relapsing Remitting Multiple Sclerosis

Summary: teva is developing laquinimod tablets as a new oral treatment for ms. laquinimod has immunomodulating properties. in a previous clinical study laquinimod showed evidence of biological activity by reducing the number of acute brain lesions. the duration of the current study is 36 weeks.


Eligibility criteria:
inclusion criteria: 1. willing and able to give written informed consent 2. confirmed ms diagnosis as defined by the mcdonald criteria 3. r-r ms disease course. 4. at least one gadolinium-enhanced lesion on screening mri 5. women of child-bearing potential must practice a reliable method of birth control. 6. must understand the requirements of the study and agree to comply with the study protocol. exclusion criteria: 1. subjects who suffer from any form of progressive ms. 2. any condition which the investigator feels may interfere with participation in the study. 3. subjects with a clinically significant or unstable medical or surgical condition that would preclude safe and complete study participation, 4. subjects who received any investigational medication, immunosuppressives or cytotoxic agents within 6 months prior to screening 5. previous treatment with immunomodulators within two months prior to screening

Keywords: relapsing remitting multiple sclerosis
to assess the feasibility of same day discharge following a poem procedure

Conditions: Esophageal Achalasia

Summary: this is a study of an investigational surgical procedure for the treatment of achalasia the inability of smooth muscle to move food down the esophagus. a new procedure, called the poem procedure (per oral endoscopic myotomy) has been developed for achalasia. this study is being performed to determine if patients can go home on the same day as their procedure.

this is a study of an investigational surgical procedure for the treatment of achalasia the inability of smooth muscle to move food down the esophagus. standard care for participants includes heller myotomy, a laparoscopic procedure that includes cutting the muscle layers in the lower esophageal sphincter (les) the valve at the bottom of your esophagus. a second procedure is then required to prevent reflux (acid entering the esophagus from the stomach) called fundoplication. patients with the heller myotomy will typically stay overnight in hospital. a new procedure, called the poem procedure (per oral endoscopic myotomy) has been developed for achalasia. this procedure uses endoscopy and no incisions to cut one muscle layer. a fundoplication is not required with this method. this study treatment works by entering the surgical area through the mouth and then making an incision (cut) through the esophagus and placing flexible instruments along the outside of the esophagus and down to the les through a tunnel. the instruments used in this procedure are standard endoscopic instruments that will be provided by one of the leading endoscopic instrument manufacturers, olympus. the investigators have recently completed a small study showing this procedure is safe and feasible. one observation from this pilot study was that most patients had no pain and didn't need any pain medications. due to this reason, the investigators think patient's may go home on the same day as their procedure.

Eligibility criteria:
inclusion criteria: participants must meet all of the following inclusion criteria: * candidate for a heller myotomy * their age is ≥18 years and ≤80 years * able to give written consent exclusion criteria: participants who meet any of the following criteria at the time of the baseline visit are not eligible to be enrolled in this study: * previous heller myotomy or poem procedure * contra-indication to general anesthesia * previous mediastinal surgery hiatal hernia greater than 2 cm * any anatomical esophageal anomaly that in the opinion of the investigator may render the intervention more difficult, such as sigmoid esophagus on the pre-operative barium swallow or hiatal hernia \> 2cm. * any medical condition, which in the judgment of the investigator and/or designee makes the subject a poor candidate for the investigational procedure * pregnant or lactating female (women of child bearing potential must take a pregnancy test prior to surgery)

Keywords: achalasia surgery