Kornimate/medical-research-clean huggingface dataset:
trichuris suis ova (tso) suspension versus placebo in active crohn's disease

Conditions: Crohn´s Disease

Summary: this study will run in centers in germany, denmark, austria, czech republic, and switzerland, only. this proof-of-concept study aims to evaluate the efficacy of three doses of oral tso suspension vs. placebo for the induction of remission in crohn's disease.


Eligibility criteria:
major inclusion criteria: * signed informed consent, * man or woman between 18 and 75 years of age, * established diagnosis of crohn's disease (cd) since at least 3 months prior to screening confirmed by endoscopic and histological, or endoscopic and radiological criteria, * negative pregnancy test in females of childbearing potential. major exclusion criteria: * bowel surgery within the last 3 months prior to baseline, * resection of more than 50 cm of the ileum, * ileostomy or colostomy, * septic complications, * evidence of infectious diarrhoea (i.e., pathogenic bacteria or clostridium difficile toxin in stool culture), * abscess, perforation, fistulas, or perianal lesions, * immediate surgery required (e.g., major stenosis, serious bleeding, peritonitis, ileus), * clinical signs of stricturing disease, * parenteral or tube feeding, * abnormal hepatic function (alt or alp \> 2.5 x upper limit of normal \[uln\] at screening), liver cirrhosis, or portal hypertension, * abnormal renal function (cystatin c \> uln) at screening, * any severe concomitant cardiovascular, renal, endocrine, or psychiatric disorder, which in the opinion of the investigator might have an influence on the patient's compliance or the interpretation of the results, * any condition associated with significant immunosuppression, * active malignancy or treatment with anticancer drugs during the last 5 years. * existing or intended pregnancy or breast-feeding, * participation in another clinical trial within the last 30 days, simultaneous participation in another clinical trial, or previous participation in this trial.

Keywords: crohn´s disease trichuris suis randomized placebo induction of remission porcine whipworm
endoscopic breast surgery in treating patients with breast cancer

Conditions: Male Breast Cancer; Recurrent Breast Cancer; Stage IA Breast Cancer; Stage IB Breast Cancer; Stage II Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer; Stage IV Breast Cancer

Summary: rationale: endoscopic breast surgery (ebs) is a less invasive type of surgery for breast cancer and may have fewer side effects and improve recovery. purpose: this clinical trial studies endoscopic breast surgery in treating patients with breast cancer.

primary objectives: i. to determine the surgical complication rate in patients undergoing ebs for benign or malignant disease and the 5-year local recurrence rate following endoscopic breast surgery among subjects undergoing ebs for breast cancer at usc. secondary objectives: i. to evaluate the safety, breast cosmesis and patient quality of life following ebs. outline: patients undergo endoscopic breast surgery. after completion of study treatment, patients are followed up every 6 months for 5 years.

Eligibility criteria:
inclusion criteria: * breast cancer or prophylactic mastectomy requiring axillary nodal staging * breast disease (e.g., fibroadenoma, adh) * ability to read and/or comprehend consent form and questionnaires * ability to follow-up per protocol * not pregnant or breastfeeding exclusion criteria: * pregnant or breastfeeding * evidence of chest wall or skin\* involvement * note: \*may be endoscopy-assisted
preoperative intratumor dendritic cells injection immunotherapy for patients with pancreatic cancer

Conditions: Pancreatic Cancer

Summary: the purpose of this study is to confirm safety and immunological responses of preoperative intratumor dendritic cells injection immunotherapy using immature dendritic cells with s pyogenes preparation (ok-432) for patients with resectable pancreatic cancer for pancreatic cancer patients.

the prognosis of pancreatic cancer is extremely poor even with extensive surgery, and development of new treatment modalities is much-expected for cure of this disease. dendritic cells (dcs) immunotherapy is expected favorable outcome when it is approached directly to the cancer tissue. to evaluate safety and immunological responses, we conducted a phase i/ii study of intra-tumor dcs immunotherapy for pancreatic cancer patients.

Eligibility criteria:
inclusion criteria: resectable pancreatic cancer without distant metastasis: 1. ecog performance status 0-2 2. laboratory values as follows 3,500/mm3 \ 100,000/mm3 t-bil\ 50ml/min normal ecg 3. able and willing to give valid written informed consent exclusion criteria: 1. pregnancy (women of childbearing potential: refusal or inability to use effective means of contraception) 2. breast-feeder 3. active or uncontrolled infection 4. active or uncontrolled other malignancy 5. steroids or immunosuppressing agent dependant status 6. interstitial pneumonia 7. decision of unsuitableness by principal investigator or physician-in-charge

Keywords: preoperative intratumor dendritic cells pancreatic cancer ok-432
combination of local therapy and target therapy for brain metastases with egfr mutation

Conditions: Brain Metastases

Summary: the goal of this observational study is to learn about the survival benefit of local therapy combination with target therapy in lung cancer brain metastases with egfr mutation. the main questions it aims to answer are: * is local therapy performed before or after target therapy would provide survival benefit ? * what kind of local therapy combining with target therapy would provide survival benefit, neurosurgical resection or radiotherapy?


Eligibility criteria:
inclusion criteria: 1. evidence of pathological diagnosis of primary tumor. 2. brain metastases confirmed by enhanced magnetic resonance imaging. 3. gene test indicated that egfr mutation. 4. complete clinical information. exclusion criteria: 1. if surgical treatment is accepted, the surgical treatment is not tumor resection, but ventricle puncture, biopsy and other non-tumor reducing surgery. 2. patients with 2 or more types of tumors. 3. incomplete clinical information.
cardiovascular prevention during covid-19 pandemic lockdown in young adults (cola trial)

Conditions: Cardiovascular Prevention Behaviour

Summary: the study aims to determine the impact of covid-19 pandemic lockdown on cardiovascular prevention behaviour.

the covid-19 pandemic resulted in a lockdown and social distancing in most countries all over the world. the impact of this national intervention on cardiovascular prevention behaviour (physical exercise, nutrition, smoking) is unknown. the cola trial aims to help clarifying these questions. an online survey was distributed among bavarian students with standardized questions about physical activity, nutritional behavior, smoking and alcohol intake before and during lockdown.

Eligibility criteria:
inclusion criteria: healthy adults over 18 years exclusion criteria: any condition that does not allow physical activity

Keywords: covid-19 cardiovascular prevention physical exercise risk factor nutrition
corifollitropin alfa versus follitropin beta in high responders

Conditions: Infertility

Summary: the purpose of this randomized controlled trial (rct) is to compare a single injection of corifollitropin-alfa versus daily injections of follitropin beta regarding the number of oocytes retrieved, hormonal profile and follicle development in patients with high response undergoing ovarian stimulation for in vitro fertilization treatment using a gonadotropin-releasing hormone (gnrh) antagonist protocol combined with gnrh agonist trigger and cryopreservation of all embryos.

corifollitropin alfa, a novel fusion protein lacking luteinizing hormone (lh) activity, has a longer elimination half-life and extended time to peak levels than recombinant follicle stimulating hormone (rfsh). a single injection of corifollitropin alfa may replace seven daily injections follitropin beta during the first week of ovarian stimulation, reducing patient discomfort. the purpose of this rct is to compare a single injection of corifollitropin-alfa versus daily injections of follitropin beta regarding the number of oocytes retrieved, as well as hormonal profile and follicle development in patients with high response undergoing ovarian stimulation for ivf using a gnrh antagonist protocol. in addition, incidence of unexpected ovarian hyperstimulation syndrome (ohss) will be evaluated, although it is anticipated that gnrh agonist triggering will eliminate occurrence of the syndrome.

Eligibility criteria:
inclusion criteria: * age: 18-40 years * polycystic ovaries (pco) or polycystic ovary syndrome (pcos) * no endometriotic cyst exclusion criteria: * patients with poor response * patients using human chorionic gonadotropin (hcg) for triggering final oocyte maturation.

Keywords: ovarian stimulation corifollitropin alfa gnrh antagonist protocol high responders follitropin beta
effects of transvertebral direct current stimulation in humans

Conditions: Spinal Cord Injuries; Paraplegia and Tetraplegia

Summary: this study will evaluate the effects of non-invasive stimulation of the spinal cord in people with spinal cord injury.

this study will use a non-invasive form of spinal stimulation, called transvertebral direct current stimulation, or tvdcs. it currently is not clear what effects this type of stimulation has on the excitability of the brain and spinal cord in people with spinal cord injury. in this study, subjects will participate in 3 sessions, with at least 1 week in between sessions, during which they will get a different condition of tvdcs. we will test the excitability of the brain and spinal cord before and after tvdcs in each session.

Eligibility criteria:
inclusion criteria: * 18 to 65 years of age * motor incomplete spinal cord injury classified as b, c, or d by the american spinal injury association impairment scale (ais) * more than 12 months post-injury * lesion at of above thoracic level t8 * body mass index \<30 (in order to facilitate reliable location of body landmarks guiding stimulation) * severe gait deficit exclusion criteria: * unstable cardiopulmonary conditions * history of seizure, head injury with loss of consciousness, severe alcohol or drug abuse, and/or psychiatric illness * cognitive deficits severe enough to preclude informed consent * positive pregnancy test of being of childbearing age and not using appropriate contraception * ferromagnetic material in the brain or in the spine (except for titanium for segmental fixation of the spine) * cardiac or neural pacemakers * fixed contractures in the lower extremities * uncontrolled diabetes * severe osteoporosis * severe spasticity * decubitus ulcers which interfere with harness support or walking * severe orthostatic hypotension

Keywords: neuroplasticity transvertebral direct current stimulation transspinal direct current stimulation
thermarthrose: gonarthrosis and water cure

Conditions: Osteoarthritis, Knee; Pain

Summary: the main objective of this study is to evaluate the therapeutic effect of a thermal treatment on gonarthrosis, with an increase of the number of patients presenting a clinically significant improvement.

gonarthrosis is a frequent pathology and the prevalence increase with age (prevalence: 6,1% in an adult population more than 30 years old and 40% after 75 years). it has a large impact on the quotidian life of the patients and it cause important costs for social protection. relative to the treatment, numerous recommendations have been proposed (eular, acr specifically). but no one of them recommends thermal treatment even if it is largely used in europe and especially in france for the treatment of this pathology. several prospective controlled randomized studies have evaluated the effect of the thermal treatments in rheumatology and some of them are relative, in part, to gonarthrosis. so, we conduct a phase iii randomized, controlled, single blind study evaluating the therapeutic effect at 6 month of a thermal cure on gonarthrosis. in a situation of physical treatment, it's impossible to use a placebo as control: blind can't be respected. whatever the methodology employed, non blind of the patient create a bias. so, we hope that the zelen method for randomization will reduce the bias due to the dissatisfaction of the patients in the control group.

Eligibility criteria:
inclusion criteria: * acr criteria: knee pain and one of the tree following conditions: age \> 50 years, morning stiffness\< 30 minutes and articular crackling. * osteophytes visible on knee radiography. * knee radiography less than 3 years old: face, schuss, axial of kneecap cliché. * actual gonarthrosis intensity on visual analogic scale \> or = 30mm. exclusion criteria: * arthrosis limited to the femoro-patellar compartments. * severe depressive syndrome, psychosis. * thermal cure less than 6 month before. * contra-indication or predictable inability to tolerate thermal cure. * profession lied to hydrotherapy. * previous knee treatments: * massage, physiotherapy and acupuncture since less than 1 month; * infiltration since less than 3 months; * nsai since less than 5 days; * analgesic since less than 12 hours; * modification in the medicinal anti-arthrosis treatment since less than 3 months.

Keywords: visual analogic scale of pain womac indice sf-36 quality of life hydrotherapy
pharmacokinetics distribution of raltegravir by pet/mr

Conditions: HIV-1-infection

Summary: this is a single-center drug distribution and pharmacokinetic study of a single microdose of 18f-raltegravir given to 10 hiv-infected subjects who are either taking or not taking a raltegravir-containing art regimen. after administration of iv 18f-raltegravir, subjects will undergo pet/mri in order to determine the distribution of radiolabeled drug through the lymphoreticular system and other tissues throughout the entire body.


Eligibility criteria:
inclusion criteria: * age ≥18 years * hiv infection * initiated a combination art (haart) regimen exclusion criteria: * screening absolute neutrophil count \ 100 units/l, alanine aminotransferase \>100 units/l. * serious illness requiring hospitalization or parental antibiotics within the preceding 3 months. * any vaccination 2 weeks prior to baseline (day 0) visit and throughout the study period. * concurrent treatment with immunomodulatory drugs, or exposure to any immunomodulatory drug in the preceding 16 weeks (e.g. corticosteroid therapy equal to or exceeding a dose of 15 mg/day of prednisone for more than 10 days, il-2, interferon-alpha, methotrexate, cancer chemotherapy). note: use of inhaled or nasal steroid use is not exclusionary. * pregnant or breastfeeding women. females of childbearing potential must have a negative serum pregnancy test at screening and agree to use a double-barrier method of contraception throughout the study period. * have a cardiac pacemaker or other indwelling foreign object that are contraindicated for mr imaging.
cd19-directed car t cells therapy in relapsed/refractory b cell malignancy

Conditions: Leukemia; Lymphoma

Summary: relapsed/refractory leukemia and lymphoma lack effective treatment. the cancer immunotherapy with chimeric antigen receptor (car) t cells provides a potent new approach for them. in this clinical trial, the investigators aim to assess the safety and efficacy of administering t cell expressing an anti-cd19 cars to patients with chemotherapy resistant or refractory cd19 positive b cell malignancy including leukemia and lymphoma.

tongji hospital of tongji university has developed an investigational approach for treating patients with cd19 positive b cell malignancy that involves taking white blood cells from the patient, growing them in the laboratory in large numbers, genetically modifying these specific cells with lentivirus to attack cd19 positive cells, and then giving the cells back to the patients.the main purpose of the study is to assess the safety and efficacy of the treatment with anti-cd19 car-t cells in the patients with chemotherapy resistant or refractory cd19 positive b cell malignancy including leukemia and lymphoma.

Eligibility criteria:
inclusion criteria: * patients with cd19+ leukemia or lymphoma, meeting the following criteria: * at least 2 prior combination chemotherapy regimens (not including single agent monoclonal antibody (rituximab) therapy) * less than 1 year between last chemotherapy and progression * not eligible or appropriate for allo-hsct * to be aged 6 to 85 years * estimated survival of ≥ 6 months, but ≤ 2 years * ecog score ≤2 * relapse after auto-hsct * women of childbearing potential must have a urine pregnancy test taken and proven negative prior to the treatment. all patients agree to use reliable methods of contraception during the trial period and until follow-up for the last time * voluntary participation in the clinical trials and sign the informed consent exclusion criteria: * history of epilepsy or other cns disease * patients have gvhd, which needs treatment with immunosuppressive agents * patients with prolonged qt interval or severe heart disease * patients in pregnancy or breast-feeding period * uncontrolled active infection * active hepatitis b or hepatitis c infection * concurrent use of systemic steroids. recent or current use of inhaled steroids is not exclusionary * previously treatment with any gene therapy products * feasibility assessment during screening demonstrates \<20% transduction of target lymphocytes, or insufficient expansion (\<5-fold) in response to cd3/cd28 costimulation * alt /ast\>3 x normal value; creatinine\> 2.5 mg/dl; bilirubin \>2.0 mg/dl * any uncontrolled medical disorders that the researchers consider are not eligible to participate the clinical trial * hiv infection * any situation that would increase dangerousness of subjects or disturb the outcome of the clinical study according to the researcher's evaluation
study on the mechanism of zhenqifuzheng in the treatment of allergic rhinitis based on intestinal flora and metabolites

Conditions: Rhinitis, Allergic

Summary: zhenqi fuzheng granules has been used to improve the immune function of human body, protect the bone marrow and adrenal cortex function and promote the recovery of positive function in traditional chinese medicine care, especially with the immune imbalance diseases like post-surgery, chemotherapy and rhinitis. this project intends to establish ar（allergic rhinitis）specimen library, cell and animal model experiment, combining clinical cohort research with applied basic research, further assess the therapeutic mechanism of zhenqifuzheng granules in ar. we assume that zhenqi fuzheng granules could cause the metabolic omics changes of nasal inflammatory factors and nasal secretions in ar patients, thus improving the type 2 inflammation level of allergic rhinitis.


Eligibility criteria:
inclusion criteria: * adult patients (18-65 years). * patients who visited the department of otolaryngology of the first affiliated hospital of nanjing medical university and are diagnosed as allergic rhinitis . exclusion criteria: * patients who refused to accept specimen and questionnaire collection. * patients who had nasal diseases other than allergic rhinitis, such as nasal papilloma and nasal malignant tumor.
pain function and qol undergoing whole-body vibration and exercise in end-stage knee osteoarthritis

Conditions: Knee Osteoarthritis; Pain, Joint

Summary: knee osteoarthritis (koa) is a chronic progressive disease that imparts substantial socioeconomic burden to society and healthcare systems. the prevalence of koa has dramatically risen in recent decades due to consistent increases in life expectancy, and demand for joint replacement continues to rise. total knee replacement is indicated for end-stage koa, as it is very effective in terms of pain relief, improvement of function, and quality of life. however, the investigators will be facing an unsustainable joint replacement burden, with significant healthcare budget and health workforce implications. to alleviate this problem, different strategies including reinforce the importance of education and exercise are included; as previous studies showed that less than 40% of patients with koa received non-pharmacological treatment, indicating that the uptake of evidence-based guidelines in clinical practice and rehabilitation is still suboptimal. several literatures revealed that quadriceps and hamstrings strength exercise could effectively reduce pain. it has widely accepted that patients with end stage koa will eventually pursue total knee replacement as the only viable option, and exercise has low efficacy in reduction of pain and disability in this group of patients. so, the investigators would like to know whether exercise therapy can help severe koa patients


Eligibility criteria:
inclusion criteria: * patients with end-stage knee osteoarthritis on queue for scheduling primary total knee replacement * completed 8-week course of physiotherapy program exclusion criteria: * tkr during the last 12 months * severe heart failure or neurological diseases affecting physical functions
sensory versus motor level neuromuscular electrical stimulation

Conditions: Stroke, Ischemic

Summary: dysphagia is a serious cause of morbidity and mortality in stroke survivors. electrical stimulation is often included as part of the treatment plan for dysphagia, and can be applied at a sensory or motor level intensity. however, evidence to support these different modes of stimulation is lacking. this study compared the effectiveness of sensory and motor level stimulation on post-stroke dysphagia.

objective: dysphagia is a serious cause of morbidity and mortality in stroke survivors. electrical stimulation is often included as part of the treatment plan for dysphagia, and can be applied at a sensory or motor level intensity. however, evidence to support sensory versus motor stimulation is lacking. this study compares the effect of sensory and motor stimulation on post-stroke dysphagia. design: randomized controlled trial setting: inpatient rehabilitation facility. participants: participants (50-75 years of age) who had dysphagia caused by a stroke within 6 months prior to enrollment were included. participants were excluded if they had a contraindication for electrical stimulation, previous stroke, psychiatric disorder, contraindications for mbs, or pre-stroke swallowing disorders. interventions: each patient received ten, 45-minute anterior neck sensory or motor level electrical stimulation sessions in addition to standard speech therapy. motor stimulation was administered as a stimulus intensity sufficient to produce muscle contractions. sensory stimulation was defined as the threshold when the patient feels a tingling sensation on their skin (approximately 4-5ma). main outcome measures: swallow fim, national outcome measurement system (noms), dysphagia outcome severity scale (doss), and change in modified diet.

Eligibility criteria:
inclusion criteria: * 18-80 * acute ischemic cva within the first month and confirmed by mri. * diagnosis of dysphagia will be obtained by bedside swallowing exam and mbs/fees studies. exclusion criteria: * patients who have contraindications for electrical stimulation (malignancy, dvt/thrombophlebitis, hemorrhagic conditions, pregnancy, pacemaker or other electrical hardware) * known premorbid swallowing disorders * gerd * dementia or psychiatric disorder * bilateral cerebral involvement * contraindications for fees/mbs (infectious disease such as hiv, hcv, hbv, nasal obstruction, decompensated heart disease, risk of bleeding such as active ulcers, allergy to contrast).

Keywords: dysphagia swallow stimulation