Kornimate/medical-research-clean huggingface dataset:
gwa study in patients with inflammatory bowel disease

Conditions: Crohn's Disease; Ulcerative Colitis

Summary: the aim of this study is to identify new genes in chinese patients that help investigators to understand the biological pathway and functions in a population in whom the incidence of inflammatory bowel disease (ibd) is increasing. and to explore the genetic variations in chinese patients with ibd.

crohn's disease (cd) and ulcerative colitis (uc) are chronic inflammatory disorders of the gut that cause major life-long disability. afflicting mostly young people at an age when they are most active both in their private and professional life, inflammatory bowel disease (ibd) represents an important public health problem affecting both the patients education, working abilities, social life . in the past two decades, the incidence and prevalence of cd and uc have been rapidly increasing in asia. familial aggregation, twin studies, and recent genetic studies suggest that there is an important genetic component to ibd. in the west, genome wide association (gwa) studies have identified more than 50 genes associated with cd including genes involved in bacterial handling, nod 2, and the genes involved in autophagy atg16l1 and irgm. only a few of these genes have been studied in asian populations. of those which have been studied, such as nod2, there have been clear differences from western populations. to date most of the gwa studies have been carried out in cohorts of caucasian patients. genetic studies in ethnically different populations may identify new causal variants in ibd, which are likely to lead to further insights into pathophysiology and potential treatments. the aim is to perform a gwa study in chinese patients with cd and uc. identifying new genes in chinese patients will help the investigators to understand the biological pathway and functions in a population in whom the incidence of ibd is increasing. as part of a collaborative project with china, we aim to collect blood samples from 1600 ibd patients and 2000 control subjects in hong kong to conduct a gwa study. samples of 300 ibd patients and 500 controls will be contributed to a collaborative project with china.

Eligibility criteria:
inclusion criteria: * age 18 or above * informed consent given by patient or family case group (ibd patients) diagnosis of crohn's disease or ulcerative colitis defined by endoscopy, radiology and histology control group (non-ibd cases) ethically, sex and aged-matched controls attending clinics or endoscopy for functional upper gastrointestinal diseases or screening colonoscopy. exclusion criteria: * no consent * controls will be excluded if they have previously been diagnosed with ibd or if they have a first or second degree relative with ibd.
a study of oral cfg920 in patients with castration resistant prostate cancer

Conditions: Prostatic Neoplasms

Summary: this study was supposed to have assessed the safety and preliminary antitumor activity of cfg920, a new cyp17 inhibitor in castration resistant prostate cancer patients who are abiraterone naive or abiraterone resistant. the study was terminated after phase i (dose escalation phase) and phase ii part of the study was not initiated. novartis voluntarily terminated this study and hence stopped further enrollment of patients into this study. as the decision to terminate the study was not due to any safety issues, the patients enrolled in the study by the time of this decision were allowed to continue with treatment per the protocol.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of castration resistant prostate cancer * documented metastases * ecog performance status 0 or 1 * documented progression following the prostate cancer working group 2 guidelines * fresh or archived tumor sample exclusion criteria: * impaired cardiac function * uncontrolled hypertension despire appropriate medical therapy * history of pituitary or adrendal dysfunction * chronic steriod therapy other than daily use of 10mg prednisone * impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of oral cfg920 * brain metastases that have not been adequately treated * malignant disease other than that being treated in this study * laboratory abnormalities as specified in the protocol other protocol-defined inclusion/exclusion criteria may apply

Keywords: prostate cancer, castration resistant,
facilitating the behavioral treatment of cannabis use disorder

Conditions: Cannabis Dependence

Summary: cannabis use disorders remain a significant public health problem. the pharmacological facilitation of behavioral treatment represents a promising strategy for addressing disordered cannabis use. cannabis use disorders are recognized to be associated with various vulnerabilities that complicate the course of treatment and that may be amenable to glutamate modulators. the purpose of this single blind open-label trial is to test the feasibility of administering glutamate modulators in conjunction with motivational enhancement therapy (met) and mindfulness based relapse prevention (mbrp) for cannabis use disorders.

individuals diagnosed with cannabis dependence will receive one or two infusions of glutamate modulators during week 2 and week 3 or 4. the participants will also receive 2-week course of met and 4-week course of mbrp. participants will meet with staff twice weekly, except for week 2 and potentially week 3 or 4 during which participants will present to the clinic three times. clinic visits include met sessions, mbrp sessions, psychiatric monitoring, assessments, and study procedures (e.g., medication administration).

Eligibility criteria:
inclusion criteria: * meets dsm-iv criteria for cannabis dependence, with at least 5 days of use per week over the past 30 days and displaying at least one positive utox during screening * physically healthy * no adverse reactions to study medications * 21-60 years of age * capacity to consent and comply with study procedures * seeking treatment exclusion criteria: * meets dsm iv criteria for current major depression, bipolar disorder, schizophrenia, any psychotic illness, including substance-induced psychosis, and current substance-induced mood disorder. * physiological dependence on another substance requiring medical management, such as alcohol, opioids, or benzodiazepines, excluding caffeine, and nicotine. * pregnant, interested in becoming pregnant, or lactating * delirium, dementia, amnesia, cognitive disorders, or dissociative disorders * current suicide risk or a history of suicide attempt within the past 2 years * on psychotropic or other medication whose effect could be disrupted by participation in the study * recent history of significant violence (past 2 years). * heart disease as indicated by history, abnormal ecg, previous cardiac surgery. * unstable physical disorders which might make participation hazardous such as end-stage aids, hypertension (\>140/90), anemia, pulmonary disease, active hepatitis or other liver disease (transaminase levels \< 2-3 x the upper limit of normal will be considered acceptable), or untreated diabetes * previous history of misuse of study medications * bmi \> 35, or a history of undocumented obstructive sleep apnea * first degree relative with a psychotic disorder (bipolar disorder with psychotic features, schizophrenia, schizoaffective disorder, or psychosis nos)

Keywords: cannabis mindfulness based relapse prevention motivational enhancement therapy
obstructive sleep apnoea in sarcoidosis

Conditions: Sarcoidosis; Obstructive Sleep Apnea; Fatigue; Sleepiness

Summary: sarcoidosis is a multisystemic granulomatous disease of unknown origin. fatigue is a common problem in sarcoidosis affecting between 50% and 80% of patients, and thus represents a major impairment of their quality of life. the findings of recent studies suggest a high prevalence of obstructive sleep apnoea (osa) in patients with sarcoidosis, estimating a range from 17% to 67%. pathomechanisms leading to this increased osa prevalence are still unclear, yet likely to be multifactorial including sarcoid myopathy and neuropathy leading to impaired integrity of the upper airways as well as corticosteroid induced obesity. while both diseases, sarcoidosis and osa, could lead to fatigue and excessive daytime sleepiness (eds) the current managing strategies differ significantly. osa patients are mostly treated with continuous positive airway pressure (cpap) whereas sarcoidosis associated fatigue may require increased immunosuppressive therapy. little is known about treatment of fatigue and sleepiness in patients suffering from both conditions.this study aims to close this knowledge gap and define prevalence of osa in a swiss cohort with sarcoidosis patients. therefore, we plan a prospective, observational, controlled study to investigate the prevalence of sleepiness, fatigue, life quality and obstructive sleep apnoea in patients with sarcoidosis. patients treated in the university hospital zurich due to sarcoidosis will be invited by letter to take part in this study. after confirmed consent and baseline assessments at the university hospital zurich, these patients will undergo a single night, in-home sleep study to assess possible osa. sleepiness and fatigue specific questionnaires and in-home respiratory polygraphy (orp) are obtained in all subjects. to assess inflammation status and other conditions connected to sleepiness like hypothyroidism and anaemia, sarcoidosis patients will undergo blood sampling.


Eligibility criteria:
inclusion criteria: * sarcoidosis group: subjects with a definite diagnosis of sarcoidosis according to international ats and wasog guideline. * informed consent * 18 years or above * control group: no sarcoidosis, no osa exclusion criteria: * moribund or severe disease prohibiting protocol adherence * continuous positive airway pressure treatment for osa at baseline * use of oxygen therapy or home ventilation * physical or intellectual impairment precluding informed consent or protocol adherence * pregnant patients
safety and feasibility of amniotic fluid as a treatment for covid-19 patients

Conditions: SARS CoV-2

Summary: the purpose of this study is to explore the effectiveness of processed human amniotic fluid as a treatment for covid-19.

past use of human amniotic products (i.e., membrane and fluid) has previously been fda-approved as a human cells, tissues, and cellular and tissue-based products (hct/p) under 21 cfr 1271 for tissue injury; and has been used to reduce inflammation and fibrosis in patients with a variety of ailments. given this, the investigators hypothesize that intravenously (iv) administered processed sterile filtered amniotic fluid will reduce inflammation in covid-19 patients, and improve secondary clinical outcomes. specifically, the investigators hypothesize that patients who receive iv administered haf will see a 50% reduction in mean c-reactive protein levels following treatment. data sharing: trial results will be published in peer reviewed publications upon completion of analysis.

Eligibility criteria:
inclusion criteria: 1. age \>18 2. sars cov-2 laboratory positive test, obtained within 14 days of enrollment 3. hospitalized 4. covid-19 symptomatic (cough, fevers, shortness of breath, and/or sputum production) 5. has a room air pulse oximetry of ≤94% and requires supplemental oxygen therapy 6. patients of childbearing potential who agree to use acceptable methods of contraception for 90 days after last administration of study investigational product (ip) 7. patients who are receiving standard of care therapies for covid-19 that are not fda approved are eligible for this study 8. subjects must be able to consent to the study (i.e., glasgow coma scale score of ≥14) 9. patients are required to have controlled blood pressure of \<160/96 and a pulse of \<110. exclusion criteria: 1. patients on invasive mechanical ventilation (e.g., endotracheal intubation) 2. chronic home oxygen utilization 3. home or current use of immunosuppressive medications (including steroids) 4. women who are pregnant, breastfeeding, or become pregnant during the study 5. patients on non-invasive positive pressure ventilation 6. patients on \>12 liters per minute via non-rebreather (nrb) or \>80% oxygen via high flow nasal cannula 7. patients who, in the opinion of the pi, have impending respiratory failure, defined as requiring rapidly escalating oxygen supplementation 8. patients with a hemoglobin \<9 mg/dl 9. patients diagnosed with stage 4 or 5 chronic kidney disease (ckd) 10. patients with diagnosed new york heart association (nyha) class 4 or 5 congestive heart failure 11. patients with a left ventricular assist device (lvad) 12. patients with thromboembolic phenomena 13. patients with type 2 and above heart block 14. patients with established positive bacterial blood cultures prior to enrollment 15. patients with ongoing pericardial effusion or ascites 16. patients with clinically significant arrhythmia 17. patients with liver function tests (alt or ast) \>3x normal 18. patients with untreated hiv infection 19. patients diagnosed with end-stage organ disease

Keywords: amniotic fluid covid-19
abi v dry needling for plantar fasciitis

Conditions: Plantar Fasciitis

Summary: to investigate whether a procedure of ultrasound-guided autologous blood injections (abi), which includes a dry-needling component within the overall procedure, has any measureable clinical benefit over ultrasound-guided dry needling alone in patients with chronic plantar fasciitis.


Eligibility criteria:
inclusion criteria: 1. patients aged 18 or over who are being seen in the department of sports medicine (all of whom are age 16 or over) with chronic plantar fasciitis of at least 6 months duration 2. failure of previous conservative therapy - including physiotherapy, and podiatry input 3. objective evidence of plantar fasciitis - either ultrasound or mri investigations 4. no contraindications of injection therapy - anticoagulation, blood borne illness, strong needle phobia ... exclusion criteria: 1. patients with either partial or full-thickness tears of plantar fascia found on investigations 2. subjects who are unable to give valid consent for study entry based on normal competency assessment 3. subjects unable or unwilling to undergo the rehabilitation plan post-procedure 4. subjects unable or unwilling to attend the follow-up appointments post-procedure
telerehabilitation in individuals with chronic disease

Conditions: Telerehabilitation

Summary: telerehabilitation applications are a treatment method that uses new technologies. there are examples of doing for many diseases in our country. it is a method used for people living in remote areas and people who cannot complete their treatment in hospitals due to the epidemic. in our study, we will use the telerehabilitation system. in this system, which we will use in people with chronic disease, we aim to see improvement in tests performed in many areas such as physical activity level, respiratory capacity, depression, and anxiety level of patients. in the study to be performed on 60 patients, 30 people will be control and 30 people will be the experimental group. the experimental group will be treated with a video conferencing method, tailor-made exercise program based on the international physical activity questionnaire level for 30 minutes 3 days a week for 6 weeks. the control group will only be informed with the help of a brochure with a standard exercise program. the tests we can use in this experiment are as follows: barthel daily life activities index, beck depression and anxiety scale, ferrans power quality of life index, charlson comorbidity index, environmental measurements, waist/hip ratio, fatigue severity scale, international physical activity questionnaire. tests specific to chronic diseases will be applied to patient one to one.


Eligibility criteria:
inclusion criteria: * having a chronic disease * to be able to communicate verbally * being in a stable period in terms of disease * at least 3 months for the disease to be chronic * regulated hypertension * diabetes patients should have them blood sugar under 200 during therapy exclusion criteria: * dementia * being a cancer patient receiving chemotherapy * epilepsy and a history of seizures * patient who has recently undergone surgery * pregnancy * delirium * bedridden

Keywords: chronic disease exercises social isolation
epidural electrical stimulation for stroke patients - improve motor and sensory function and alleviate pain

Conditions: Stroke

Summary: this study aims to verify whether epidural electrical stimulation (ees) of the cervical spinal cord can activate muscles of the upper limbs in people with hemiplegia following a stroke.

the purpose of this study is to verify whether epidural electrical stimulation (ees) of the cervical spinal cord can activate muscles of the arm and hand in people with hemiplegia following stroke. participants will undergo a surgical procedure to implant a system that provides epidural electrical stimulation (ees) of the cervical spinal cord. after surgery, participants will undergo a structured physical rehabilitation program and electrical stimulation. researchers will quantify the motor potentials in the arm and hand muscles generated by ees of the cervical spinal cord, tune optimal stimulation parameters to induced arm and hand movement, and assess participant motor function of the upper limb with standard clinical tests and simple motor tasks.

Eligibility criteria:
inclusion criteria: * between 20 and 70 years of age * first-ever clinical manifest stroke * right or left hemiparesis * scores higher than 7 and lower than 45 on the fugl-meyer scale. * expected will undergo spinal cord stimulation surgery. * able to comply with procedures and follow up. * stable medical condition without cardiopulmonary disease or dysautonomia that would contraindicate participation in upper extremity rehabilitation or testing activities. exclusion criteria: * pregnancy or breast feeding. * have major depressive disorder. * had a mental illness within one year or been treated in the past. * have significant cognitive impairment (mmse\<24) or serious disease that could affect the ability to participate in study activities. * cardiovascular or musculoskeletal disease or injury that would prevent full participation in physical therapy intervention. * receiving anticoagulant, anti-spasticity or anti-epileptic medications prior to or throughout the duration of the study. * unable to read and/or comprehend the consent form. * have concerns about this trial and do not sign consent. * presence of joint contractures deemed by study clinician/investigator to be too severe to participate in study activities.
infant formula with partially hydrolyzed cow's milk protein versus a formula with intact protein

Conditions: Infant Colic

Summary: randomized, parallel, double-blind clinical trial, comparing a partially hydrolyzed serum proteins infant formula with a conventional formula with intact protein in healthy infants that suffer from colic

demonstrate that an infant formula with partially hydrolized cow's milk protein of serum proteins is equivalent to an intact protein formula in healthy children in terms of safety of use and suitability, to prove that it can be a alternative with digestive health benefits in healthy children with infant colic.

Eligibility criteria:
inclusion criteria: * children diagnosed as nursing colic according to roma iv criteria. * infants who have received breastfeeding at least 2 weeks. * infants who at the time of inclusion in the study whose parents/legal guardians voluntarily decide not to continue exclusive breastfeeding or only maintain it in residual form (less than 20% of the daily intake, one breast intake per day). * full-term infants (\>37 weeks of gestation). * infants with weight suitable for their gestational age (2500-4500g). * normal apgar score: 7-10. * infants between 2 and 8 weeks of life. * infants whose parents/legal guardians have signed informed consent. * infants with good availability of clinical follow-up until the end of the study. exclusion criteria: * infants fed from birth with exclusive infant formula. * infants with congenital diseases or malformations that may affect growth. * infants with major medical conditions that require chronic medication or close medical checks. * infants who have taken any type of antibiotics or probiotics prior to the study.

Keywords: infant formula partially hydrolized protein infant formula
crossover bioequivalence study of tinidazole 500 mg tablets under fed conditions

Conditions: Trichomoniasis

Summary: the objective of this study was to prove the bioequivalence of roxane laboratories' tinidazole 500 mg tablet under fed 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 tinidazole or any comparable or similar product.
stress doses of hydrocortisone on coagulation dysfunction in patients with septic shock

Conditions: Septic Shock; Sepsis

Summary: the purpose of this study is to find out whether stress doses of hydrocortisone attenuate coagulation dysfunction in patients with septic shock. and discuss the probable mechanism by which little doses of hydrocortisone influence coagulation system in sepsis.

patients were randomized to receive either low-dose hydrocortisone or matching placebo.severity of coagulopathy was estimated using isth dic score. we determined the complications and mortality in two groups, and analyzed the relationship between hydrocortisone and coagulopathy.

Eligibility criteria:
inclusion criteria: * all patients(age≧18y) * admitted for septic shock were considered eligible if they had no life-threatening systemic disease (asa groups 1\~3) exclusion criteria: * lactation * mental disorders * disseminated cancer * secondary cancers * inflammatory bowel disease, or diseases hindering epidural analgesia

Keywords: coagulopathy hydrocortisone organ failure hemodynamic improvement induced by hydrocortisone