Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of rtms plus rehabilitation for the improvement of the upper extremity in stroke (eres)

Conditions: Stroke; Arm Paralysis

Summary: the rehabilitation of the upper limb after a stroke is a challenge due to its complexity and the important cerebral representation of it, particularly of the hand. repetitive transcranial magnetic stimulation (rtms) is a tool that can broaden the effect of rehabilitation and thus appears to be observed in different studies performed in patients in chronic phase. however, there are little data on its usefulness before 6 months after the stroke. the variability in the presentation, the fact that it is a phase where the motor deficit of the upper limb coexists with other deficits and medical problems partly explain the lack of specific studies. the investigators present here a preliminary study on the efficacy of rtms associated with the rehabilitation program of the paretic upper extremity due to a stroke in comparison with sham rtms. patients (with moderate to mild involvement) will be randomly distributed in the two study groups and will be evaluated both clinically and neurophysiologically before and after the sessions to try to demonstrate if there is a positive effect in a safe manner.


Eligibility criteria:
inclusion criteria: * patients with a stroke (ischemic-hemorrhagic) that conditions a limitation unilateral (brachial monoparesis or hemiparesis) and presenting a moderate or mild deficit (motor score on the fm scale ≥ 22 at the motor level of the upper extremity) * to participate in the study the patient must sign an informed consent and be older than 18 y.o. exclusion criteria: * patients with epilepsy or those with devices will be excluded from the study in your body or metallic at the brain level, as well as patients with craniotomy without cranioplasty. * also excluded are all patients whose conditions prevent them from complying with the rehabilitation protocol.

Keywords: stroke rtms upper limb rehabilitation
thoratec heartmate ii left ventricular assist system (lvas) for bridge to cardiac transplantation

Conditions: Heart Failure, Congestive; Ventricular Dysfunction; Cardiomyopathies

Summary: the purpose of this study is to determine the safety and effectiveness of the thoratec heartmate ii left ventricular assist system (lvas) as a bridge to cardiac transplantation in end-stage heart failure patients who are listed for cardiac transplant but are at imminent risk of dying. the heartmate ii lvas was approved by the us fda on april 21, 2008, as a bridge to cardiac transplantation (reference pma p060040). it was approved for commercial distribution in canada on may 20, 2009 (reference medical device licence #79765). patients enrolled into the clinical trial will continue to be followed until all have reached a clinical outcome.

the heartmate ii is a high speed, electric, axial flow, rotary blood pump. the pump drains blood from the left ventricular apex via a rigid inlet cannula and ejects into the aortic root via an outflow cannula joined to the aorta with an end to side anastomosis. power and control of the pump are delivered through a percutaneous cable from the pump to the belt-worn system driver. patient outcomes will be compared to objective performance criteria based on historical data from other thoratec implantable ventricular assist devices.

Eligibility criteria:
inclusion criteria: the following are general criteria; more specific conditions are included in the study protocol: * listed for cardiac transplantation * nyha class iv heart failure symptoms * on inotropic support, if tolerated * despite medical therapy, the patient must meet hemodynamic criteria for cardiogenic shock exclusion criteria: the following are general criteria; more specific conditions are included in the study protocol: * evidence of, or risk factors for end-organ dysfunction that would make lvas implantation futile * existence of factors that would adversely affect patient survival or function of the lvas. * intolerance to anticoagulant or antiplatelet therapies. * existence of any ongoing mechanical circulatory support other than intra-aortic balloon counterpulsation. * participation in any other clinical investigation that is likely to confound study results or affect study outcome.

Keywords: heart-assist devices
trk-3 conformance to standards for tonometers

Conditions: Glaucoma

Summary: to collect measurements of a new tonometer and show conformance to standards for tonometers.


Eligibility criteria:
inclusion criteria: 1. age at least 22 years at the time of the informed consent 2. provide voluntary written consent for participation in the study exclusion criteria: 1. have only one functional eye 2. have difficulty in ocular fixation or eccentric fixation in either eye 3. have corneal scar or have a history of corneal surgery such as corneal laser surgery (cataract surgery is acceptable) 4. have microphthalmia 5. have buphthalmos 6. wear contact lens (have used soft contact lenses within the last 3 months and/or hard contact lenses within the last 6 months) 7. have dry eyes and taking prescription medication or using artificial tears daily 8. have blepharospasm 9. have nystagmus 10. have keratoconus 11. have corneal or conjunctival lesions or infections 12. have a central corneal thickness of \ 600μm 13. have corneal astigmatism \>3d 14. have known allergy to ophthalmic anesthetics 15. have known allergy to sodium fluorescein
longterm outcome of inpatient cognitive and behavioral therapies for agoraphobia

Conditions: Agoraphobia

Summary: while cognitive therapy and exposure therapy are both proven to be effective for panic disorder and/or agoraphobia when outcome is assenssed up to one year after treatment (gould et al., 1995) the scientific knowledge about long-term course of these disorders is still scanty. although several long-term outcome studies have been conducted, the quality of these studies has been questioned. the aim is to conduct a follow-up study of patients with either panic disorder with history of agoraphobia or agoraphobia without history of panic disorder. the patients were treated in a group format at modum bad during the years 1989 to 1997. four subsamples will be included in the study. subsample 1 (76 patients treated in 1989 and 1990) received combined cognitive and psychodynamic treatment. subsample 2 and 3 (46 patients treated in 1992 - 1993) were allocated to either cognitive therapy or guided mastery treatment. subsample 4 (45 patients treated in 1994 - 1996) received cognitive and schema focused therapy. in the follow-up study the participants will be requested to complete the same self report measures as they completed at intake, discharge and at previous follow-up times. the participants will also be interviewed using the scid-i and ii as they were at the previous assessments. the present sample is relatively unique in having received pure psychosocial experimental treatments. the very long term efficacy of cognitive therapy relative to behavioural treatmetns for agoraphobia can be evaluated, and the potential moderating effects of personality disorders can be assessed.


Eligibility criteria:
inclusion criteria: * meet the dsm-iv kriteria for either panic disorder, panic disorder with agoraphobia or agoraphobia exclusion criteria: * psychosis * dementia * substance abuse

Keywords: long term outcome
speech, linguistic and acoustic markers in parkinson's disease

Conditions: Parkinson Disease; Cognitive Impairment, Mild; Speech

Summary: the investigators aim to identify speech and language markers that provide information on cognitive function and predict cognitive decline in parkinson's disease. the investigators will administer speech tasks and cognitive assessments to participants with parkinson's disease and healthy controls. the investigators will also explore the associations between genetic factors and speech and cognitive status in parkinson's disease.


Eligibility criteria:
inclusion criteria: * parkinson's disease (or healthy control) * disease duration ≥ 2 years * mild cognitive impairment or normal cognition exclusion criteria: * diagnosis of dementia (moca \<21) * adults unable to consent * age \< 18 * pregnant women * prisoners * non-english speakers * any neurological disorder other than pd * deep brain stimulator placement * severe, unstable psychiatric disorder * unintelligible speech due to effects of pd * visual acuity or color vision impairment that would interfere with cognitive testing * other voice, speech or swallowing disorders or history of surgery involving palate/nasopharynx/larynx/vocal cords
safety & effectiveness of the pxl-platinum 330 system for cxl using riboflavin solution

Conditions: Keratoconus; Pellucid Marginal Corneal Degeneration; Corneal Degeneration; Corneal Ectasia

Summary: safety and effectiveness of the pxl-platinum 330 system for corneal collagen cross-linking in eyes with corneal thinning conditions

patients with progressive keratoconus, pellucid marginal degeneration, or at risk for post-refractive corneal ectasia will be recruited and undergo epithelial-on corneal crosslinking with the peschke pxl-330 system using pulsed, accelerated energy delivery. patients will undergo monitoring for 1 year, with serial measurements of corneal topography, visual acuity, pachymetry, and visual function.

Eligibility criteria:
inclusion criteria: * 8 years of age or older * signed written informed consent * willingness and ability to comply with schedule for follow-up visits * contact lens wearers only: * removal of contact lenses (if applicable) for the required period of time prior to the screening refraction: soft, discontinue 3 days; soft extended wear, discontinue 3 days; soft toric, discontinue 3 days; rigid gas permeable, discontinue 2 weeks (subjects who cannot function without wearing their contact lenses, may forgo discontinuation of contact lenses) and one or more of the following: * presence of central or inferior steepening. * axial topography consistent with keratoconus, post-surgical ectasia, or pellucid marginal degeneration * presence of one or more findings associated with keratoconus or pellucid marginal degeneration, such as: fleischer ring, vogt's striae, decentered corneal apex, munson's sign, rizzutti's sign, apical corneal scarring consistent with bowman's breaks, scissoring of the retinoscopic reflex, crab-claw appearance on topography * steepest keratometry (kmax) value ≥ 47.20 d * i-s keratometry difference \> 1.5 d on the pentacam/orbscan map or topography map * posterior corneal elevation \>16 microns * thinnest corneal point \>300 microns exclusion criteria: * eyes classified as either normal or atypical normal on the severity grading scheme. * corneal thickness \< 300 microns measured by ultrasonic pachymetry or pentacam. * previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications, for example: history of or active corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, etc.) clinically significant corneal scarring in the cxl treatment zone that is not related to keratoconus or, in the investigator's opinion, will interfere with the cross-linking procedure. * pregnancy (including plan to become pregnant) or lactation during the course of the study * a known sensitivity to study medications * patients with nystagmus or any other condition that would prevent a steady gaze during the cxl treatment or other diagnostic tests. * patients with a current condition that, in the physician's opinion, would interfere with or prolong epithelial healing
a phase 2b study of du-176b, prevention of venous thromboembolism in patients after total knee arthroplasty

Conditions: Venous Thromboembolism; Deep Vein Thrombosis; Total Knee Arthroplasty

Summary: the objective of this study is to assess the efficacy, safety and dose-response relationship of du-176b compared with placebo for the prevention of venous thromboembolism in patients after elective total knee arthroplasty.


Eligibility criteria:
inclusion criteria: * patients undergoing unilateral total knee arthroplasty exclusion criteria: * risks of hemorrhage * thromboembolic risks * weight less than 40 kg * pregnant, suspect pregnancy, or subjects who want to become pregnant

Keywords: prevention venous thromboembolism edoxaban factor xa
clinical study of fecal microbiota transplantation in the treatment of antibiotic-associated diarrhea

Conditions: Fecal Microbiota Transplantation; Antibiotic-associated Diarrhea

Summary: antibiotic-associated diarrhea (aad) refers to the occurrence of other unexplained diarrhea symptoms after the use of antibiotics, often combined with abdominal pain, bloating and bloody stool. fecal microbiota transplantation (fmt) is a therapeutic method to transplant the microbiota from the feces of healthy people into the intestinal tract of patients. to explore the overall efficacy and safety of fmt in the treatment of aad.


Eligibility criteria:
inclusion criteria: * occurrence of antibiotic-associated diarrhoea; no response to standard therapy; agree to receive fmt and sign informed consent; willingness to provide stool samples. exclusion criteria: * non-antibiotic-associated diarrhea; did not accept fmt or did not sign informed consent; unwillingness to provide stool samples.
the effect of multiple injection of platlet-rich plasma in chronic patellar tendinopathy

Conditions: Tendinopathy

Summary: according to previous studies, the effect of prp to patellar tendinopathy could last longer. however, the type, concentration, time and frequent of injection are still debated。 this study is to understand the effect of multiple injection of platlet-rich plasma in chronic patellar tendinopathy and to analyze the relation between efficacy of prp and the growth factor in prp.

patellar tendinopathy, also known as jumper's knee，is clinically common characterised by anterior knee pain, activity-related pain、local tenderness over inferior pole of patella. the discomfort can result in decreasing athletic performance and be one of the most challenge for sports medicine doctor. the patellar tendon suffer from repetitive microtrauma，result in reactive patellar tendinopathy. the overload tendon combining with risk factors of patellar tendinopathy will not recover timely and progress to chronic patellar tendinopathy. hence, to reverse the progression is our aim. according to previous studies, several nonsurgical treatment options have been proposed such as medication, eccentric exercise, corticosteroid injection, shockwave and platelet-rich plasma (prp). among all the options, the effect of prp could last longer. however, the type, concentration, time and frequent of injection are still debated。moreover, there is no study about the relationship between efficacy and the ratio and concentration of growth factor in the prp. the aim of this study is to understand (1) the effect of multiple injection of platlet-rich plasma in chronic patellar tendinopathy. (2) the effect of leukocyte-rich prp in chronic patellar tendinopathy (3) analyze the relation between efficacy of prp and the growth factor in prp.

Eligibility criteria:
inclusion criteria: chronic patellar tendinopathy exclusion criteria: 1. corticosteroid injections within 12 months 2. previous knee surgery 3. any confounding diagnosis to the knee joint 4. arthritis 5. rheumatoid arthritis 6. diabetes 7. infections of knee joint 8. nsaids in the 10 days before the procedure
determining patterns in trial experiences of recurrent prostate cancer patients

Conditions: Recurrent Prostate Cancer

Summary: clinical studies, with a dedicated focus on recurrent prostate cancer, play a pivotal role in evaluating the safety and effectiveness of novel treatments for this condition. these trials serve as essential tools to determine whether new medications outperform traditional therapies, providing substantial evidence to endorse their broader utilization. it will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future patients with recurrent prostate cancer.


Eligibility criteria:
inclusion criteria: * patient is at least 18 years of age * diagnosis of recurrent prostate cancer * ability to understand and the willingness to sign a written informed consent document exclusion criteria: * enrolled in another research study * patients with psychiatric illness/social situations that would limit compliance with study requirements * inability to provide written informed consent

Keywords: recurrent prostate cancer
beneficial effect of adding pentoxifylline to processed semen samples on icsi outcome in infertile males

Conditions: Pentoxifylline Allergy

Summary: to evaluate the effect of pentoxifylline used in preparation of semen samples that will be used for icsi in infertile men complaining of mild and moderate asthenozoospermia (i.e. cases which does not need motility enhancement prior to icsi) in comparison to semen samples without pentoxifylline preparation on the outcome of icsi.

the primary outcome measures were the number of oocytes retrieved, the number of oocytes injected, number of oocytes fertilized, fertilization rate, number of embryos and their quality (g1: good embryos, g2: fair embryos and g3: bad embryos), number of embryos transferred (et), number of embryo sacs, embryo implantation rate, pregnancy rate and abortion rate for all 3 groups and pregnancy rate and abortion rate for both group (i) and group (ii).

Eligibility criteria:
inclusion criteria: * seeking icsi for infertility exclusion criteria: * pyospermia, presence of antisperm antibodies. azoospermia, severe male factor, severe asthenozoospermia. past history of orchitis. patients who received empirical treatment for asthenozoospermia e.g. oral pentoxifylline, l-carnitine or antioxidants during the past 3 to 6 month. diabetics, hypertensives or patients with any other chronic systemic illnesses. wife's age more than 35 years. low antral count. presence of any ovarian factor contributing to infertility e.g. polycystic ovaries.
efficacy and safety study of wve-210201 (suvodirsen) with open-label extension in ambulatory patients with duchenne muscular dystrophy

Conditions: Duchenne Muscular Dystrophy

Summary: this is a phase 2/3, multicenter, randomized, double-blind, placebo-controlled study with an open-label extension period to evaluate the safety and efficacy of wve-210201 (suvodirsen) in ambulatory male pediatric patients with duchenne muscular dystrophy (dmd) amenable to exon 51 skipping intervention (dystance 51)


Eligibility criteria:
inclusion criteria: 1. diagnosis of dmd based on clinical phenotype with increased serum creatine kinase 2. documented mutation in the dystrophin gene associated with dmd that is amenable to exon 51 skipping 3. ambulatory male, able to walk independently for at least 10 meters in 10 seconds or less at the time of screening visit (performed as part of the nsaa) 4. stable pulmonary and cardiac function, as measured by: 1. reproducible percent predicted forced vital capacity (fvc) ≥50% 2. left ventricular ejection fraction (lvef) \>55% in patients \ 45% in patients ≥10 years of age, as measured (and documented) by echocardiogram 5. currently on a stable corticosteroid therapy regimen, defined as initiation of systemic corticosteroid therapy occurred ≥6 months prior to screening, and no changes in dosing ≤3 months prior to screening visit exclusion criteria: 1. cardiac insufficiency: 1. severe cardiomyopathy that, in the opinion of the investigator, prohibits participation in this study; however, cardiomyopathy that is managed by angiotensin-converting-enzyme (ace) inhibitors or beta blockers is acceptable provided the patient meets the lvef inclusion criterion 2. any other evidence of clinically significant structural or functional heart abnormality 3. a cardiac troponin i value \> 0.2 ng/ml 2. need for daytime mechanical or non-invasive ventilation or anticipated need for daytime mechanical or non-invasive ventilation within the next year, in the opinion of the investigator. nighttime non-invasive ventilation is permitted 3. received prior treatment with drisapersen or with an investigational peptide-conjugated phosphorodiamidate morpholino oligomer (ppmo) 4. received prior treatment with gene therapy for dmd 5. received treatment with ataluren or eteplirsen within the 14 weeks prior to the planned baseline biopsy collection 6. received any investigational drug within 3 months or 5 half-lives, whichever is longer, prior to the planned baseline biopsy collection
ssgj-707 in advanced non-small cell lung cancer

Conditions: Advanced Non-Small Cell Lung Cancer

Summary: this trial is a phase iii study. all patients are stage iiib/c (unsuitable for radical therapy) or iv non-small cell lung cancer(nsclc), eastern cooperative oncology group (ecog) performance status 0-1. the purpose of this study is to evaluate the efficacy and safety of ssgj-707 comparing pembrolizumab in subjects with advanced nsclc whose tumors have a programmed cell death-ligand 1 (pd-l1) tumor proportion score (tps) greater than or equal to 1%.


Eligibility criteria:
inclusion criteria: 1. willing to participate in the study voluntarily, agree to comply with and complete all study procedures, and sign the informed consent form (icf). 2. at least 18 years of age at the time of signing the icf, regardless of gender. 3. eastern cooperative oncology group (ecog) performance status (ps) of 0 or 1. 4. life expectancy of at least 12 weeks. 5. histologically or cytologically confirmed locally advanced (stage iiib/iiic) or metastatic (stage iv) non-small cell lung cancer (nsclc). 6. no prior systemic anti-tumor treatment for locally advanced or metastatic nsclc. 7. at least one measurable tumor lesion as a target lesion according to recist v1.1 criteria. exclusion criteria: 1. presence of small cell carcinoma components in histological pathology. 2. presence of egfr-sensitive mutations or alk fusion-positive nsclc. 3. known braf v600e mutation, met exon 14 skipping mutation, ntrk fusion, ret fusion, or ros1 fusion-positive nsclc. 4. presence of brainstem, leptomeningeal, spinal cord metastasis or compression. 5. unresolved toxicity from prior anti-tumor treatment, defined as toxicity not returning to nci ctcae version 5.0 grade 0 or 1. 6. history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation. 7. history of immunodeficiency; positive for hiv antibodies; 8. known active tuberculosis (tb); 9. known history of severe allergy to any component of the investigational drug, or history of severe allergic reactions to chimeric or humanized antibodies. 10. pregnant or breastfeeding women. the above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.