Kornimate/medical-research-clean huggingface dataset:
a trial measuring art-123 ability to prevent sensory neuropathy in unresectable mcrc subjects w/oxaliplatin-based chemo

Conditions: Chemotherapy-induced Peripheral Neuropathy

Summary: to evaluate the efficacy and safety of art-123 on sensory symptoms of oxaliplatin-induced peripheral neuropathy (oipn) in patients with unresectable metastatic colorectal cancer who receive oxaliplatin-containing chemotherapy

to compare the efficacy and safety of art-123 (low and high dose) to placebo on sensory symptoms of oxaliplatin-induced peripheral neuropathy (oipn) in patients with unresectable metastatic colorectal cancer who receive oxaliplatin-containing chemotherapy

Eligibility criteria:
inclusion criteria: * 18 years of age or older * unresectable metastatic colorectal cancer; pathologically confirmed adenocarcinoma of the colon or rectum * ecog performance status of 0 or 1 * the most recent laboratory findings (including for liver and kidney) within 14 days prior to randomization remain within acceptable ranges * willingness of the patient and the sexual partner to use a highly effective contraceptive method during the course of the study * able to sufficiently understand the clinical study and give written informed consent exclusion criteria: * prior treatment history with nerve toxic chemotherapeutic agent * peripheral neuropathy or central nervous system damage * psychiatric disorder * history of major hemorrhage * high risk of hemorrhage * history of other malignancies * active ulcer * patients using anti-coagulants and fibrinolytic drugs * active hepatitis b, or known hbs antigen positive * prior treatment history with thrombomodulin alfa * administration of another investigational medicinal product within 30 days prior to randomization * patient is pregnant (positive urine human chorionic gonadotropin) or breastfeeding or intends to get pregnant during the treatment period * patients otherwise deemed as inappropriate to participate in the study by the investigator
efficacy and safety of rebel reliever brace in patients with symptomatic medial knee osteoarthritis

Conditions: Osteoarthritis, Knee

Summary: the purpose of the study is to evaluate the superiority of rebel reliever® knee brace + standard treatment versus standard treatment alone in terms of last 24-hour pain relief after 6 weeks. in patients with medial knee osteoarthritis.

the main criteria is the evaluation of global knee pain during the last 24 hours at d 49 after the inclusion. the response to the treatment will be evaluated during the inclusion visit (v1/d0) and after 6 weeks of treatment, during the following visit (v3/d49). the level of the global pain of the patient during the last 24 hours will be collected by investigators with a vas (0 mm = no pain ; 100mm = maximun pain) at each visit.

Eligibility criteria:
main inclusion criteria: * male or female over 18 years * bmi \< or egal to 35kg/m2 * symptomatic gonarthrose defined by a recurrent pain to the walk on 30 days during the last 2 months before the inclusion with radiological findings (grade ii to iv on kellgren-lawrence) * diagnosis of medial femoro-tibial knee osteoarthrosis * patient with global pain intensity during the last 24hours \> or egal 40 mm (eva) at the day of selection main exclusion criteria: * femoro-patellar predominant arthrosis * septic arthritis * metabolic arthropathies * chronical rheumatismal diseases * other knee diseases * symptomatic coxarthrosis * controlateral gonathrosis with corticoids injections * any other serious disease which may interfere with the results * psychiatrics disorders * skin lesions or dermal pathologies * venous or arterial disorders * sensitivity disorders in the lower limbs (diabetes mellitus..) * paracetamol intolerance * hyaluronic acid or corticosteroid intra-articular injection in the last month prior to inclusion * on going knee viscosupplementation at inclusion * slow acting oa drugs (if started in the last 2 months prior to inclusion) * opioids, corticosteroids, or nsaids intake in the last 48 hours prior to inclusion * pregnant women of with no contraception * hepatic or renal insufficiency
save hearts in arizona registry and education (share) project

Conditions: Out-of-hospital Cardiac Arrest

Summary: evaluation of the impact of bystander cpr, prehospital resuscitation protocols, and hospital post-resuscitation protocols for out-of-hospital cardiac arrest patients in the state of arizona.


Eligibility criteria:
inclusion criteria: * out of hospital cardiac arrest (loss of spontaneous circulation and ems attempted resuscitation) exclusion criteria: * do not resuscitate

Keywords: cardiac arrest, cpr, resuscitation
low-intensity extracorporeal shock wave treatment for erectile dysfunction: a randomized, controlled, double blind trial

Conditions: Erectile Dysfunction

Summary: the proposed mechanism of action for li-eswt in ed is that it improves endothelial function and triggers angiogenesis through induction of local growth factors and endothelial nitric oxide synthase. the literature generally confirms that li-eswt is safe and cohort studies investigating the clinical effects have been encouraging. meanwhile, randomized trials have shown contradictory results. thus, a randomized trial in 67 pde5-i responders showed statistically greater improvements in the erectile function domain of the international index of erectile function (iief) with active li-eswt treatment compared to a sham treatment (p=0.032).


Eligibility criteria:
inclusion criteria: * age 18-70 years * a history of erectile dysfunction for \>6 months * iief-ed score \< 25 * in a stable heterosexual relationship for at least 6 months * willingness to attempt sexual intercourse at least twice per week during the study and follow-up exclusion criteria: * psychogenic ed as assessed by a standardized interview (attachment 2) * known psychiatric illness * neurological disease (including parkinson's disease, multiple sclerosis, spinal cord injury, and a history of stroke) * traumatic nerve injury * previous pelvic surgery or radiation * heart disease in the form of unstable angina, nyha class \>ii heart failure, uncontrolled arrhythmia, or significantly symptomatic and/or severe valvular disease * endocrine disease including hypogonadism (total testosterone \<12 nmol/l) * insulin dependent or uncontrolled diabetes mellitus * dependence on erectogenic aids other than pde5-inhibitors * use of medications which have been shown to interfere with erections * use of anticoagulant medications other than low dose aspirin * active cancer * a diagnoses of peyronie's disease and/or prior occurrence of priapism * alcohol abuse (more than 21 containers of alcohol per week)
a diagnostic accuracy study testing fecal biomarkers in comparison to endoscopic examination

Conditions: Inflammatory Bowel Diseases

Summary: in this study it will be explored whether the levels of fecal biomarkers are associated with histologic inflammation of the intestinal mucosa and concomitant alteration of the mucosal permeability. the aim of the study is to assess the diagnostic accuracy of fecal biomarkers especially to detect the potential of differentiation between inflammatory and functional gastrointestinal diseases. the following biomarkers will be examined in the stool of the participants: calprotectin, lactoferrin, pmn-elastase, human beta-defensin, zonulin, alpha-antitrypsin.

for this study inpatients and outpatients of the clinic for integrative medicine and naturopathy bamberg, germany, who had a routine gastroscopy and/or coloscopy with tissue biopsy or an endoscopy with confocal laser endomicroscopy and tissue biopsy were enclosed. these patients, who were examined during a routine diagnostics, should submit an extra morning stool sample up to two weeks before or after the gastroscopy and/or coloscopy to generate the data of the fecal biomarker mentioned above. on the basis of the biopsy samples generated through the routine examination we can determine the histology scores, nancy index and riley score. the determined scores, the data of the fecal biomarkers and the results of the confocal laser endomicroscopy as well as, if available, more clinical data such as the clinical activity index (cai), the mayo-score/disease activity index (dai), the endoscopic rachmilewitz-index (rei) and the questionnaire for inflammatory bowel disease (ibdq) will be anonymised inserted into a spss data bank and will then be interpreted. for the adequate description of the collective data of gender, age, blood levels and medication will be gathered and added to the data bank anonymised. the calculated data will then be compared with the clinical evaluation of the patients with symptomatic irritable bowel syndrome, active inflammatory bowel diseases and patients with other gastrointestinal diseases. the aim of this study is to develop improved methods for non invasive diagnostics of gastrointestinal diseases.

Eligibility criteria:
inclusion criteria: * adults * signed declaration of consent * presence of a confirmed diagnosis of 1. inflammatory bowel diseases 2. irritable bowel syndrome 3. gastrointestinal diseases, except participants with diagnosis of group 1 or 2 (e.g. celiac disease, food allergies, microscopic colitis, diverticulosis, diverticulitis) 4. healthy controls as part of a preventive medical check-up exclusion criteria: * no indication for endoscopic examination as part of routine care * age under 18 years

Keywords: inflammatory bowel diseases fecal biomarkers calprotectin lactoferrin pmn-elastase human beta-defensin zonulin
lung overdistension and abdominal pressure rise

Conditions: Respiratory Failure; Respiratory Distress Syndrome, Adult

Summary: the goal of this pilot interventional no-profit study is to evaluate airway pressure, esophageal pressure and variations in lung volume distribution with eit in mechanically ventilated patients admitted to our uti with respiratory failure after the application of an abdominal weight and resulting increase of intra-abdominal pressure.


Eligibility criteria:
inclusion criteria: * invasive mechanical ventilation in acute respiratory failure (pao2/fio2 \<300 mmhg) * need of peep trial * need of urinary catheter (used to measure iap) exclusion criteria: * contraindication to eit use * pacemaker or other metal device in thoracic region * contraindication to abdominal weight placement * surgical or traumatic incision on the abdomen * severe abdominal hypertension * esophageal diseases that counterindicate naso-gastric tube placement * severe hemodynamic instability (norepinephrine \> 0.1 mcg/kg/min; dobutamine or dopamine \> 5 mcg/kg/min; epinephrine every dosage) * severe obesity (bmi \> 35 kg/m2) * need of \> 7 kg weight to reach 5 mmhg iap increase

Keywords: abdominal pressure overdistension
ktp green light prostatectomy compared with tur-p in high risk patients

Conditions: BPH (Benign Prostatic Hyperplasia)

Summary: the purpose of this study is to compare safety and efficacy of green light pvp (photoselective vaporization of the prostate) compared to tur-p in high risk patients


Eligibility criteria:
inclusion criteria: * men with anticoagulant medication undergoing surgery for bph exclusion criteria: * previous prostate surgery * carcinoma of the prostate * neurogenic bladder * bladder carcinoma
filgotinib versus placebo in adults with active rheumatoid arthritis (ra) who have an inadequate response to biologic disease-modifying anti-rheumatic drug(s) (dmards) treatment

Conditions: Rheumatoid Arthritis

Summary: the primary objective of this study is to evaluate the effects of filgotinib versus placebo for the treatment of signs and symptoms of rheumatoid arthritis (ra) as measured by the percentage of participants achieving an american college of rheumatology 20% improvement response (acr20) at week 12.


Eligibility criteria:
key inclusion criteria: * have a diagnosis of ra (2010 american college of rheumatology \[acr\]/european league against rheumatism \[eular\] criteria for ra), and are acr functional class i-iii. * have ≥ 6 swollen joints (from a swollen joint count based on 66 joints \[sjc66\]) and ≥6 tender joints (from a tender joint count based on 68 joints \[tjc68\]) at screening and day 1 * ongoing treatment with a stable prescription of 1 or 2 csdmards * have received at least one biologic disease modifying antirheumatic drug (bdmard) for the treatment of ra to which they have had an inadequate response or intolerance key exclusion criteria: * previous treatment with any janus kinase (jak) inhibitor note: other protocol inclusion/ exclusion criteria may apply.
treatment response to rehabilitation in patients with schizophrenia

Conditions: Schizophrenia

Summary: this study will examine the ways in which schizophrenia-related symptoms affect response to a rehabilitation program for people with schizophrenia.

patients with schizophrenia often suffer neurocognitive impairment and psychosocial and vocational difficulties. this study will help identify those patients most likely to benefit from existing behavioral treatments and provide clues for how to modify treatments for those who do not benefit. two studies will be conducted. the first will investigate the relationship of symptoms and neurocognitive variables at study entry to psychosocial and vocational status 2 years later. the second study will investigate the relationship of symptoms and neurocognitive variables at study entry to treatment response in patients assigned to either a cognitive remediation track or a computer skills track as part of their rehabilitation treatment. both the cognitive remediation and computer skills training programs will last 4 to 6 months. participants will be assessed pre- and post-treatment. neuropsychological, psychosocial and vocational status will be measured.

Eligibility criteria:
inclusion criteria: * dsm-iv criteria for schizophrenia or schizoaffective disorder * in need of intensive outpatient care * treatment with atypical antipsychotic medication for a minimum of 6 months prior to study entry exclusion criteria: * auditory or visual impairment * mental retardation (iq less than 70) * traumatic brain injury with loss of consciousness * presence or history of any neurological illness that may affect brain physiology * lack of proficiency in english * concurrent substance abuse and/or dependence
pf-06863135 as single agent and in combination with immunomodulatory agents in relapse/refractory multiple myeloma

Conditions: Multiple Myeloma

Summary: to assess the safety and tolerability at increasing dose levels of pf-06863135 in patients with relapse/ refractory multiple myeloma in order to determine the maximum tolerated dose and select the recommended phase 2 dose.

study c1071001 is a phase 1, open label, multi dose, multi center, dose escalation, safety, pharmacokinetic (pk) and pharmacodynamic study of pf-06863135 in adult patients with advanced multiple myeloma who have relapsed from or are refractory to standard therapy. this is a two part study; part 1 will assess the safety and tolerability of increasing dose levels of pf-06863135 and part 2 will evaluate safety and anti-myeloma activity of pf-06863135 at the rp2ds determined in part 1.

Eligibility criteria:
inclusion criteria: * relapsed/refractory multiple myeloma * progressed or are intolerant of established therapies including proteasome inhibitor, immunomodulatory drug, and anti-cd38 antibody * performance status of 0- 1 ( performance score 2 is permitted only if due to underlying myeloma) * adequate bone marrow, hematological, kidney and liver function * resolved acute effects of any prior therapy to baseline severity * not pregnant exclusion criteria: * recent history of other malignancies * history of active autoimmune disorders * any form of primary immunodeficiency * active and clinically significant bacterial, fungal, or viral infection * evidence of active mucosal or internal bleeding * history of severe immune-mediated adverse event with prior immunomodulatory treatment * major surgery within 4 weeks of study treatment start * radiation therapy within 2 weeks of study treatment start * history of stem cell transplant (autologous or allogeneic) within 100 days prior to study enrollment * donor lymphocyte infusion (dli) within 30 days prior to study entry * less than 30 days since last dose of antibody based therapies or less than 5 half-lives since last dose of previous therapy * requirement for systemic immune suppressive medication except as permitted in the protocol * current requirement for chronic blood product support

Keywords: multiple myeloma relapse/ refractory multiple myeloma bispecific antibody bispecific bcma bcma- cd3 bispecific phase 1 pf-06863135 dexamethasone lenalidomide pomalidomide
thyroid function and diabetes complications

Conditions: Diabetes; Thyroid Disease

Summary: the purpose of this study is to investigate the potential association between thyroid function and diabetes complications in the elderly subjects with type 2 diabetes mellitus (t2dm).

aims: we investigated the potential association between thyroid parameters and microalbuminuria in the euthyroid elderly subjects with type 2 diabetes mellitus (t2dm). subjects: elderly inhospital patients with t2dm who visited in the department of endocrinology at the nanjing first hospital from january 2011 to december 2012. methods: clinical factors, serum levels of glucose, lipids, free triiodothyronine (ft3), free thyroxine (ft4), thyroid-stimulating hormone (tsh), thyroid autoantibodies,24h urine albuminuria and fluorescence fundus angiography are conducted. the relationships levels of thyroid function and diabetic complications are analysed.

Eligibility criteria:
inclusion criteria: 1. patients are ≥ 60 years old, with t2dm and the diagnostic criteria of t2dm is according to the world health organization in 1999. 2. patients have normal thyroid function and negative for thyroid autoantibodies, such as thyroid peroxidase antibody (tpoab) or thyroglobulin antibody (tgab). exclusion criteria: 1. patients with a history of thyroid disease or chronic liver disease or nondiabetic renal problems or cancer. 2. patients use systemic drug therapy such as thyroxine, anti-thyroid drugs, glucocorticoids and oral contraceptives. 3. patients are pregnant or lactating women. 4. patients with acute intercurrent illness of diabetes. 5. patients with an acute infection. 6. patients with a history of drug abuse alcohol dependence in the past 5 years.

Keywords: thyroid diabetes mellitus
a randomized, double-blinded, placebo-controlled, two-way crossover study to investigate the safety and toleration of single dose sildenafil in subjects receiving chronic uk-369,0031

Conditions: Prostatic Hyperplasia; Urinary Bladder, Overactive; Erectile Dysfunction

Summary: to investigate the safety and overall tolerability of co-administration two pde5 inhibitors uk369,003 and sildenafil


Eligibility criteria:
inclusion criteria: * evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study. * healthy male subjects between the ages of 40 and 55 years, inclusive * body mass index (bmi) of approximately 18 to 30 kg/m2; and a total body weight \>50 kg (110 lbs). exclusion criteria: * evidence or history of clinically significant haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). * loss of vision in one eye due to non-arteritic ischemic optic neuropathy (naion) regardless of whether or not this event was temporally associated with the use of a pde5 inhibitor.
cardiac dysfunction and remodeling in patients with preeclampsia

Conditions: Preeclampsia; Cardiovascular Risk Factor; Pregnancy Complications

Summary: preeclampsia (pe) is a pregnancy-related hypertensive disorder drive by an anti-angiogenic environment. women with pe have 2-4 time higher risk of developing cardiovascular disease (cvd), although the specific mechanism relating these two conditions remains elusive. in non-pregnant patients with coronary disease, angiogenic profile proved to be an independent predictor of poor prognosis and is associated with a higher mortality rate. the investigators hypothesized that in pe, the antiangiogenic environment determines the degree of cardiac dysfunction and remodeling and the posterior cardiovascular risk.

main objective: to determinie the relationship between antiangiogenic environment and cardioc dysfuntion and remodelin in women at risk and in established pe. m\&m: placental dysfunction markers (angiogenic factors (plgf) and anti-angiogenic factor (sflt1) and cardiovascular risk variables (bmi, bp, arterial stiffness, copectin, probnp, high-sensitivity troponin, carotid intima thickness and echocardiography parameters) would be evaluated in 280 patients at risk of pe according to first trimester screening and 100 controls. additionally, cardiac dysfunction parameters would be evaluated in women with established pe (n=60) and common transcriptomic signatures between cardiovascular disease and preeclampsia would be investigated in placental samples from 10 pe and 10 controls. it will provide evidences to evaluate and characterize the association between angiogenic factors and cardiac dysfunction and remodeling in pe.

Eligibility criteria:
inclusion criteria: 1. \>18 and \<45 years old. 2. able to understand the study requirements. 3. singleton pregnancy. 4. accept of written informed consent. exclusion criteria: 1. \ 45 years old. 2. not able to understand the study requirements. 3. multiple pregnancy. 4. previous conditions: abnormal thrombophilia, alcohol or illicit drug use, type-1 diabetes, hyperthyroidism, renal disease, severe maternal illness, cytomegalovirus or toxoplasma infection, maternal hiv infection, , previous venous or arterial thrombotic event, and 5. known major fetal anomaly or chromosomal abnormality at inclusion 6. denial of written informed consent.
self-help program via internet for adolescents with cancer

Conditions: Cancer; Depression; Anxiety

Summary: the overall aim is to evaluate the clinical efficacy and cost-effectiveness of a self-help program via internet aiming at preventing development and maintenance of cancer-related emotional distress among adolescents with cancer.

a significant number of adolescents reports less anxiety and depression and a better quality of life than a healthy reference group from eighteen months up to four years after diagnosis. however, a significant minority of adolescents struck by cancer reports a clinically relevant level of emotional distress from shortly after diagnosis up to four years after diagnosis. the provided self-help program is designed to promote psychological health. 150 adolescents recently diagnosed with cancer will be randomized to either of two conditions: (1) early program and (2) later program. in both conditions an internet-based self-help program is provided. adolescents randomized to early program start the program directly after randomization i.e. 4 weeks after diagnosis whereas adolescents randomized to later program start the program sixty-two weeks after diagnosis. the larger part of data are collected at seven assessments, observations 1-7. observation 1 takes place 4 weeks after diagnosis (di); observation 2: 28 weeks after di; observation 3: 38 weeks after di; observation 4: 62 weeks after di; observation 5: 86 weeks after di; observation 6: 96 weeks after di and observation 7: 120 weeks after di. the main research question is to investigate whether the program is superior to standard care in preventing development and maintenance of anxiety and depression at 38 weeks after diagnosis among adolescents with cancer.

Eligibility criteria:
inclusion criteria: * adolescents aged from 13 to 19 * recent cancer diagnosis exclusion criteria: * no access to computer or internet * difficulties reading or understanding swedish

Keywords: adolescence cancer depression anxiety self-help via internet