Kornimate/medical-research-clean huggingface dataset:
familial fecal microbiota transplant for the treatment of subjects with autism spectrum disorders

Conditions: Autism; Autism Spectrum Disorder

Summary: this is an open-label clinical trial to evaluate the benefits of familial fecal microbiota transplant following a 6-week treatment with vancomycin in minor and adult subjects with asd for treatment of social deficits and language delays.

this is an open-label clinical trial to evaluate the benefits of familial fecal microbiota transplant following a 6-week treatment with vancomycin in minor and adult subjects with asd for treatment of social deficits and language delays. participants are given fmt by colonoscopy

Eligibility criteria:
inclusion criteria: 1. subject at least two years of age. 2. subject has confirmed diagnosis of asd based on the dsm-v. 3. subject with asd whose parents/caregiver/guardian/lar can complete informed consent process. 4. a reliable parent or caregiver who can report the side effects and communicate effectively with the research team. 5. stable medications during the two months prior to enrollment. 6. currently receiving interventions in the community or school for asd. 7. if male, and partner is of childbearing potential, must be willing to utilize at least one highly effective method of birth control for the duration of the study. exclusion criteria: 1. female subjects who are pregnant, nursing, or intend to become pregnant during the study period. 2. subjects whose caregivers are unable/unwilling to cooperate with the protocol requirements. 3. subject will be excluded who are suffering with rett syndrome and childhood disintegrative disorder. 4. other serious co-morbid medical disorders affecting brain function and behaviour, including uncontrolled seizures. 5. subjects unable to refrain from taking non-study antibiotics for the period of the study. 6. subjects diagnosed with cancer, except small localized basal cell carcinoma. 7. subjects known to abuse alcohol or drugs. 8. subjects who have undergone gastric bypass or total colectomy, or who are scheduled for these procedures. 9. infection with hiv. 10. infection with hepatitis b or c. 11. hepatic values greater than 20 12. allergy to benzodiazepine. 13. inability to stop loperamide, diphenoxylatye/atropine, or cholestyramine before the study 14. unable to stop opiate treatment unless on a stable dose including prn dosing, and no dose increase planned for the duration of the study 15. known positive stool cultures for enteropathogens including, but not limited to shigella, salmonella, and campylobacter within 30 days before enrollment. 16. known stool studies positive for ova and/or parasites in 30 days prior to enrollment. 17. planned travel outside united states during study period.
individual responder analysis of the effectiveness of manual therapy and exercise versus usual care in patients with chronic nonspecific neck pain

Conditions: Chronic Nonspecific Neck Pain

Summary: the aim of this study is to compare the effectiveness of a combined intervention of manual therapy and exercise versus usual care, on pain intensity, disability, and global perceived recovery, in patients with chronic nonspecific neck pain.


Eligibility criteria:
inclusion criteria: * chronic nonspecific neck pain at least 3 months, defined as pain in the cervical region without a specific anatomopathological diagnosis; * adults between 18 and 65 years of age and literate in portuguese; exclusion criteria: * history of cervical trauma and/or history of surgery in the prior 6 months; * clinical signs of infection, tumor, neurological, inflammatory or systemic diseases; * pregnancy

Keywords: chronic nonspecific neck pain exercise manual therapy
transfer of subjects from subutex/suboxone to rbp-6300

Conditions: Opioid Related Disorder

Summary: this study is designed to determine if opioid dependent subjects who are already receiving subutex and/or suboxone can transfer to rbp-6300. upon completing the study, subjects will continue their pre-study prescribed dosage of subutex and/or suboxone

during the open-label run-in period (study days -7 to -1), participants receive subutex®/suboxone® at one of three dose levels, depending on the dose level for that subject on entry to the study: 8 mg/day, 16 mg/day, or 24 mg/day. during the 7-day, active drug-controlled, double-blind transfer period (study days 1-7), participants are randomized to either subutex®/suboxone® or rbp-6300 active drug at dosing levels equivalent to the level during the run-in period plus placebo matching the other drug. this is followed by a 3-day single-blind subutex®/suboxone® transition period in which participants receive the same dose given during the run-in period.

Eligibility criteria:
inclusion criteria: * be male or non-pregnant, non-lactating females * be at least 18 years of age * meet diagnostic and statistical manual of mental disorders, dsm-iv-tr (diagnostic and statistical manual-iv-text revision)criteria for opioid dependence at screening * be on stable dose of 8, 16, or 24mg/day for about 30 days prior to screening * female subjects of childbearing potential must have a negative urine test prior to enrollment into the study exclusion criteria: * have participated in an experimental drug or device study within the last 60 days * if female, be breast feeding or lactating * have any medical condition that in the opinion of the physician investigator would preclude the subject from completing the study * have a clinically significant abnormal finding (in the opinion of the investigator)

Keywords: opioid dependence
optical coherence microscopy in dermato-oncology

Conditions: Skin Cancer

Summary: octav is a medical device class i, ce marked, based on a new technique for high-resolution imager (cell) internal microstructures of all types of biological tissues in vivo or ex vivo, to a depth of penetration 800 .mu.m. it allows to explore the epidermis, the dermo-epidermal junction and middle dermis in a totally non-invasive (direct contact with the tissue without sampling).

at the coming of the patient in dermatology for resection / biopsy of the tumor (usual practice), for the study, an image of the tumor will be performed with the octav device (about 5 minutes) for the study. then, according to usual practice, resection / biopsy will be performed. this study aims to validate the clinical relevance of this device to characterize the 3 main skin cancers and to obtain the necessary data for the implementation of future clinical trials.

Eligibility criteria:
for patient inclusion criteria: * patient with a cutaneous lesion suspicious for melanoma, basal cell carcinoma, squamous cell carcinoma, requiring a surgical excision * consent form signed * major patient exclusion criteria: * allergy or intolerance to immersion oil (used for microscopy) * if female, pregnant or breast-feeding * patient unable to stand still for 60 seconds * skin lesions located near patient eyes (\<3 cm) for control group inclusion criteria: * aged between 18 to 40 years * consent form signed * patient of the dermatology department with non-pathological forearm skin exclusion criteria: * allergy or intolerance to immersion oil (used for microscopy) * if female, pregnant or breast-feeding * patient unable to stand still for 60 seconds

Keywords: optical biopsy skin cancer diagnostic performance
a study of gastrointestinal emptying time in adult participants with migraine before and after start of a mab cgrp antagonist

Conditions: Migraine

Summary: the purpose of this study is to measure the gastrointestinal emptying time using the wireless motility capsule (wmc) technology (fda approved smartpill™) in adult participants with migraine who are taking a monoclonal antibody (mab) calcitonin gene-related peptide (cgrp) antagonist called galcanezumab or erenumab.


Eligibility criteria:
inclusion criteria: * have a diagnosis of migraine, with or without aura, as determined by the study investigator and in consideration of international headache society international classification of headache disorders - 3rd edition guidelines (ichd-3 2018) * have a frequency of less than 15 monthly headache days of which up to 14 can be migraine headache days. * participants can be on no more than 1 other migraine preventive treatment (except for tricyclic antidepressants and verapamil which are not allowed) as long as: that participant has had a stable dose of the oral migraine preventive treatment for a minimum of 2 months or participants have received onabotulinumtoxina for a minimum of 2 cycles prior to screening exclusion criteria: * participants with a history of gastric bezoars, swallowing disorders, severe dysphagia to food or pills, suspected or known strictures, fistulas, or physiological/mechanical gi obstruction * history of any abdominal surgery within the past 3 months or gi surgery with the exception of cholecystectomy, appendectomy, or nissen fundoplication * history of irritable bowel syndrome (ibs), chronic constipation, crohn's disease, celiac disease, ulcerative colitis, or diverticulitis * participants with type 1 or type 2 diabetes * participants with cardiac pacemakers or other implanted or portable electromechanical device * participants with a body mass index of ≥40 kilograms per square meter (kg/m²) * women who are pregnant or nursing * participants currently on mab cgrp antagonists or have received a mab cgrp antagonist within the past 6 months prior to visit 1 * participants who have received an oral cgrp antagonist (gepant) in the last 14 days prior to visit 1

Keywords: prevention prophylaxis headache
phase 2 study to evaluate pvx-410 + pembrolizumab + chemotherapy for metastatic, pd-l1+ triple-negative breast cancer

Conditions: Metastatic Triple-Negative Breast Carcinoma

Summary: evaluating the combination of the investigational, multi-peptide cancer vaccine pvx-410 in combination with pembrolizumab and chemotherapy in treatment naive patients with metastatic, triple negative breast cancer who are pdl1 and hla a2 positive.


Eligibility criteria:
inclusion criteria: - hla a2 positive pdl1 positive treatment naive, triple negative breast cancer exclusion criteria: -
validation of the screening instrument: prisma-7 for frailty among elderly hospitalized danes

Conditions: Frailty Syndrome

Summary: the questionnaire prisma-7 was originally developed to assess frailty in community dwelling adults. the questionnaire was translated into the danish language. this instrument was used to screen for frailty among elderly patients (75+) sent home from nykøbing falster hospital after a hospital admission during the period 31. may 2017 until december 31st, 2018. prisma results were used to categorize each individula as frail or non-frail. the register of prisma results was merged with national registers on use of health serviced in order to investigate if increasing prisma score was associated with increasing use of health services.

data from prisma scores were registered in an easytrial database. this database is recognized by the regional health authorities as a safe system to store individual health data. all use of the easytrial database is logged. the merging of data from the local easytrial database with data from national registries on use of health services and on mortality was permitted by the danish national health data protection authorities.

Eligibility criteria:
inclusion criteria: * 75 years old persons being returned from hospital after a hospital admission and in need of further physical rehabilitation in the community exclusion criteria: not able to give informed consent or if necessary not having a relative that can give informed consent
a pilot study of neuro hand orthosis program in stroke upper limb rehabilitation

Conditions: Paralytic Stroke

Summary: the implementation of neuro hand orthosis upper limb program can significantly improve the severe stroke paralytic arm in subacute rehabilitation as compared with the use of conventional therapy.

the neuro hand orthosis is based on a design of dynamic hand orthosis for orthopaedic patients. we attempt to apply such an orthosis on stroke patients to aid in regaining movement from severe paralytic arm by helping the patients to support their wrist and finger in a functional position for grasping. the patient is then encouraged to produce voluntary movement from the severe paralytic arm to transport an object (ball) from place to place either in sitting or standing position. since intensive arm usage is associated with neuro reorganisation, we propose designing a program with the neuro hand to encourage usage of the paralysed hand and help overcome the barriers of poor motivation and lack of arm usage through self practice program.

Eligibility criteria:
inclusion criteria: * post stroke between one week to three months and medically stable * right hemiplegia with right hand dominant * able to stand with minimum assistance * amt score not lesser then 7/10 * motricity index arm score \<36/100 exclusion criteria: * unable to commit to the neuro hand orthosis program (either as in or out patients) for 10 weeks according to the program regime or unable to follow the control group regime for 10 weeks * pre-existence shoulder or upper limb pain * pre-existence moderate or severe hand oedema * patients with terminal disease * resident of institution (eg, nursing home etc prior to admission) * pre-existing upper limb disability on affected arm * psychiatric problem

Keywords: stroke upper limb rehabilitation treatment movement recovery from sever paralytic upper limb neuro hand orthosis self practice program subacute
percutaneous electroneurostimulation of dermatome t6 for appetite reduction and weight loss in morbidly obese patients

Conditions: Appetite Reduction; Weight Loss

Summary: based on the creation of a somato-autonomic reflex, the stimulation of sensory nerve terminals located in dermatome t6 may cause a reflex, whose efferent pathways end in vagal nerve branches stimulating the gastric wall, similarly to the gastric pacemaker. the aim of this study was to evaluate the effect of percutaneous electroneurostimulation (pens) of t6 dermatome on appetite, weight loss and dietary compliance.


Eligibility criteria:
inclusion criteria: * patients candidates to bariatric surgery * bmi \> 40 kg/m2 or a bmi \> 35 kg/m2 with comorbidities associated to the obesity status * failure of dietary treatment. exclusion criteria: * untreated endocrine disease causing obesity * serious psychiatric illness.
fmri study of brain neural network and plasticity after stroke

Conditions: Stroke

Summary: the purposes of this study are to investigate the functional connectivity of motor network in patients of stroke and investigate the mechanism of brain plasticity for recovery after stroke.


Eligibility criteria:
inclusion criteria: * 1st-ever-stroke * whose corticospinal tract was injured * less than 1 month after stroke onset exclusion criteria: * claustrophobia * who use cardiac pacemaker * intracranial metal * uncontrolled hypertension or hypotension

Keywords: brain motor network, plasticity, functional mri, stroke
identification of new serum diagnostic markers of hepatocellular carcinoma

Conditions: Liver Cancer

Summary: the purpose of this study is to identify blood markers that have the ability to diagnose liver cancer with improved accuracy, so that it can be used alone or in conjunction with alpha-feto protein (afp)

liver cancer is a deadly cancer that is typically hard to diagnose and treat. the currently used blood marker for the clinical diagnosis of liver cancer is alpha-feto protein (afp), which misses 40-60% of patients with liver cancer because it lacks sufficient specificity and sensitivity. the purpose of this study is to identify blood markers that have the ability to diagnose liver cancer with improved accuracy, so that it can be used alone or in conjunction with afp. the aim of this study is to identify new blood markers of liver cancer that can be used to increase the rate of accurate diagnosis of this malignancy.

Eligibility criteria:
inclusion criteria: * patients diagnosed with liver cancer based on biopsy or serum afp level, associated with characteristic hypervascular liver tumors on triphasic spiral ct scan or mri. * patients with non-cancer liver conditions such as cirrhosis, adenoma, cholangioma, or nodular hyperplasia. * patients with hepatitis b or hepatitis c viral infections not associated with liver cancer. exclusion criteria: -patients will be excluded if, upon looking through their medical records, information required for data analysis are missing.
cohort study to identify predictor factors of onset and progression of parkinson's disease

Conditions: Parkinson Disease

Summary: observational, prospective, monocentric study to assess clinical features, imaging and biologic biomarkers in parkinson disease (pd) patients and rate of progression compared to healthy controls (hc) and subjects at risk to develop pd. the primary objective of this study is to identify clinical, imaging and biologic markers of pd onset and progression for use in clinical trials of disease-modifying therapies.

iceberg will be a four-year natural history study of de novo idiopathic pd patients, healthy controls, and subjects at risk to develop pd (idiopathic rem behavior disorder -irbd, and probants of patients with pd genetically confirmed). all subjects will be comprehensively assessed at baseline and every year thereafter. subjects will undergo clinical (motor, neuropsychiatric, sleep, ocular and cognitive evaluations) and imaging assessments. blood (including a dna sample), stools, skin biopsy and cerebral spinal fluid (csf) samples will be collected.

Eligibility criteria:
inclusion criteria: * all subjects: male or female age 18 years and older, mmse score \> 26, negative pregnancy test in potentially child-bearing women (contraindication to spect with datscan). * idiopathic parkinson disease subjects: diagnosis confirmed according to uk parkinson's disease society brain bank criteria (ukpdsbb); disease duration less than 3 years. * genetic parkinson disease subjects: parkinson diagnosis confirmed and mutation in parkin, lrrk2, snca or gba genes. * prodromal subjects: subjects with identified relative with pd genetically confirmed or subjects with diagnosis of idiopathic rem sleep behavior disorder (irbd); neurological examination normal (no signs of parkinsonism). * healthy subjects: neurological examination normal exclusion criteria: * all subjects: psychiatric disorder or any progressive life-threatening disease, impairment precluding appropriate information and instructions given concerning participation to the study; contra-indication to mri or spect scan. * parkinson disease subjects: no dopamine transporter deficit at spect scan; parkinsonism induced by neuroleptics; neuroleptics intake within 6 months; atypical parkinson syndrom (msa, psp, cbd...) * parkinson disease subjects with mutation in parkin, lrrk2, snca or gba gene: atypical parkinson disease syndromes due to either drugs (e.g., metoclopramide, flunarizine, neuroleptics) or metabolic disorders (e.g., wilson's disease), encephalitis or degenerative diseases (e.g., progressive supranuclear palsy) or currently taking neuroleptics or has taken neuroleptics within 6 months of baseline or any biological anomaly.

Keywords: parkinson disease biomarkers prognostic factors prodromal features disease progression
a study of jnj 10229570-aaa to evaluate safety and tolerability in japanese participants with acne vulgaris

Conditions: Acne Vulgaris

Summary: the purpose of this study is to evaluate the safety and tolerability of jnj 10229570-aaa after a single topical application of jnj 10229570-aaa 1.2% and 3.6% cream in japanese participants with acne.

this is a randomized (drug assigned by chance like flipping a coin), double blinded (neither physician nor patient knows the name of the assigned drug), single dose ascending study of jnj 10229570-aaa in japanese participants with acne. the study will evaluate the safety and pharmacokinetics (\[pk\] how the drug is absorbed in the body, how it is distributed within the body and removed from the body over time) of m1 (active metabolite) in a total of eighteen (18) participants enrolled in the study, nine (9) in each group. each participant will receive jnj 10229570-aaa at 1.2%, 3.6% or vehicle in a cream formulation as a 2.5 ml application, to the face, neck, shoulders, chest and upper back areas. the investigational product will be washed off after the blood sampling at 24 hours after application. safety and tolerability will be evaluated throughout the study and a topical dermatological assessment will be done by the dermatologists. the total duration of the study will be maximum 35 days.

Eligibility criteria:
inclusion criteria: * have acne vulgaris, presenting at least inflammatory lesion on the face * body mass index between 18.0 and 30.0 kg/m2 (inclusive), and body weight not less than 50 kg (man) or 45 kg (woman) * blood pressure between 90 and 140 mmhg systolic (inclusive), and no higher than 90 mmhg diastolic * electrocardiogram (ecg) consistent with normal cardiac conduction and function * non-smoker * adequate contraception method for both men and women. if a woman, must have a negative pregnancy test * signed an informed consent document exclusion criteria: * history of or current clinically significant medical illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results * clinically significant abnormal values for hematology, biochemistry or urinalysis * clinically significant abnormal physical examination, vital signs or ecg - use of any prescription or nonprescription medication within 14 days before the study treatment * history of drug or alcohol abuse within the past 5 years * drug allergy or drug hypersensitivity * blood donation, depending on the volume of blood collection * positive test for human immunodeficiency virus (hiv), hepatitis b or c, or syphilis * dermatological disease at application site * photosensitivity * exposure to excessive or chronic ultraviolet (uv) radiation (i.e., sunbathing, tanning salon use, phototherapy) within 4 weeks prior to study treatment or planned during the study period

Keywords: acne vulgaris jnj 10229570-aaa japanese patients topical treatment