Kornimate/medical-research-clean huggingface dataset:
study evaluating tch346 and placebo administered once daily in patients with amyotrophic lateral sclerosis (als)

Conditions: Amyotrophic Lateral Sclerosis

Summary: this is a global multicenter study designed to evaluate the safety and clinical effects of 4 oral doses of tch346 (1.0, 2.5, 7.5, and 15 mg) compared to placebo in patients with mild or mild to moderate stages of als. the study consists of 3 phases: screening (up to 2 weeks), run-in (16 weeks), and a double-blind treatment phase of variable duration (at least 24 weeks).


Eligibility criteria:
inclusion criteria: * clinical diagnosis of laboratory-supported probable, probable, or definite als; * sporadic or familial als; * als symptom onset for no more than 3 yrs at study entry; * fvc equal to or more than 70%; * patients who are either riluzole naive or patients who are receiving concomitant treatment with riluzole at a stable dose of riluzole (50 mg bid) at study start. exclusion criteria: * known or suspected chronic infectious disease including hiv, hepatitis b, or hepatitis c. * clinically significant ecg abnormalities. * known hypersensitivity to study drug or related drugs (e.g. selegiline, mao-a and b inhibitors, or tricyclic antidepressants). * patients treated with potent inhibitors of cyp1a2 or cyp3a4 (a list of such inhibitors will be provided to the investigator). * treatment with mao-a and b inhibitors (including selegiline) within the past 30 days.

Keywords: als lou gehrig's disease
novel mrna-based urine test for bladder cancer in spinal cord injury individuals

Conditions: Bladder Cancer; Spinal Cord Injury

Summary: bladder cancer is a well-recognized complication in spinal cord injury (sci) individuals. the observed incidence rates in sci individuals are considerably higher compared to the general population. bladder cancer in sci individuals tends to present at an earlier age compared to the general population. furthermore, bladder cancer in sci individuals is more commonly invasive and at a more advanced stage at the time of diagnosis compared to bladder cancer in the general population. individuals with bladder cancer commonly present with hematuria and other urinary symptoms. the gold standard for diagnosis is cystoscopy. however in sci individuals, hematuria may get attributed to catheter irritation or trauma or an urinary tract infection. furthermore, the bladder wall commonly presents with various changes under cystoscopic examination masking the presence of a bladder wall mass. thus, diagnosis of bladder cancer in sci individuals can be complicate. there is a novel test available (genexpert® bladder cancer detection, cepheid international, sunnyvale, ca, usa) for the measurement of mrna bladder tumor markers in the urine. the diagnostic accuracy of this test has been investigated in non-sci individuals with symptoms suspicious for bladder cancer. the test showed high sensitivity and specificity values and is thus a promising diagnostic or screening tool.. however, the diagnostic accuracy of the test has not yet been investigated in sci individuals. the primary objective of the proposed study is to investigate whether urine mrna tumor marker levels in spinal cord injury individuals with symptoms and findings suspicious for bladder cancer are a discriminator between individuals suffering from bladder cancer and those not suffering from cancer. individuals presenting with symptoms suspicious of bladder cancer will undergo ultrasonic and cystoscopic examination of the bladder. an urine sample will be taken, and the bladder will be flushed for collecting a bladder fluid sample. in patients with bladder wall findings suspicious of cancer, a bladder wall biopsy will be taken, according to clinical standard practice. the bladder fluid and the bladder wall biopsy will be submitted for cytology and histopathology examination, respectively. tumor mrna levels will be measured in the urine sample.


Eligibility criteria:
inclusion criteria: * symptoms suspicious of bladder cancer (haematuria, ultrasonic and cystoscopy findings) * chronic spinal cord injury for a minimum of 3 years * informed consent as documented by signature exclusion criteria: * age \< 18 years * history of bleeding disorder * bladder augmentation * acute, symptomatic urinary tract infection * pregnancy * urolithiasis * previous intravesical treatment (e.g. bladder irrigation, botulinum toxin injection) \< 2 weeks)
h. pylori eradication on healing of iatrogenic gastric ulcer by endoscopic mucosal resection

Conditions: Ulcer

Summary: this study will evaluate the effect of helicobacter pylori eradication therapy on the healing of iatrogenic gastric ulcer caused by endoscopic mucosal resection of gastric neoplastic lesions and is a multicenter, randomized, double blind, and placebo controlled trial.


Eligibility criteria:
inclusion criteria: * 30 - 75 years old * early gastric cancer (\< 3 cm in size, mucosa confined, differentiated type) or gastric adenoma (\< 3 cm in size) * helicobacter pylori positive exclusion criteria: * medication of anti-secretory drugs (proton pump inhibitors, h2-receptor antagonists, antacid, bismuth compound) * history of helicobacter pylori eradication * history of gastric surgery or other cancers * major comorbidities * medication of asa, nsaids, steroids, anti-coagulants

Keywords: endoscopic mucosal resection iatrogenic
tens and spasticity in stroke patients

Conditions: Stroke

Summary: study aims to evaluate the efficacy of high and low frequency tens on spasticity, strength and functional status in stroke patients. it may provide further knowledge concerning the use of tens for motor impairments in stroke patients and may clarify ambiguities to some extent.

despite the positive effects of electrical stimulation proved on motor impairments of affected limb, the evidence is still not conclusive. there still remains a question mark regarding the effectiveness and optimal stimulation parameters of tens. there has been conflict regarding the tens parameters (frequency, duration, intensity) among different studies. to date tens parameters used in different studies to reduce spasticity range from frequency of 1.7-100 hz, duration from 15-60 minutes and sessions from 1-30. the use of different parameters may account for the contradictory results related to effectiveness of tens.

Eligibility criteria:
inclusion criteria: * both male and female aged 40-70 years * middle cerebral artery (mca) stroke * 6 months after stroke * mini-mental state examination (mmse)more than 24 * modified ashworth scale score between1 and 2 exclusion criteria: * patients with multiple sclerosis, spinal cord injury or with other pre-existing neurological disorders. * patients with orthopedic condition affecting upper extremity * patients with contraindication to tens, like skin damaged etc.

Keywords: spasticity upper limb tens
study of sexuality in parkinson disease

Conditions: Parkinson Disease

Summary: the aim of this study is to evaluate the different aspects of sexual function among adults with parkinson disease to develop a treatment and address sexual problems as a routine part of diagnostic workup and therapeutic planning.

because there is limited literature on sexual function in parkinson disease, in this study, we examined sexual functioning in a large groups of patients with idiopathic parkinson disease compared with healthy subjects in the italian community. to assess sexual function in pd we used the brief index of sexual functioning \[(bisf-m for man; bisf-w for woman), the international index of erectile function (iief) and the female sexual function index (fsfi). participants were also assessed by the beck depression inventory (bdi). this study aimed to provide a thorough epidemiological description of sexual dysfunction in parkinson's disease. the knowledge of sexual function in pd might help to plan effective interventionist measures and ultimately to optimize patient's and the partner's quality of life. parkinson patients (aged 40-80) and 123 healthy controls (aged 40-80) will be recruited from four italian movement disorders clinics.

Eligibility criteria:
inclusion criteria: * idiopathic pd * marital status * age 40-80 exclusion criteria: * patients taking pde

Keywords: sexuality parkinson disease bisf iief fsfi
the influence of perioperative optimisation to the hip arthroplasty outcomes

Conditions: Hip Osteoarthritis

Summary: success of the hip arthroplasty depends on the measures that optimize perioperative conditions.it is planned to evaluate semi-closed loop system in the hip arthroplasty surgery.

success of the total hip arthroplasty depends on the measures that optimize perioperative conditions. they increase the emotional stress of the staff and error probability. it is planned to evaluate semi-closed loop infusion system, its adaption for infusion application's influence to near and far treatment outcomes done by prospective randomized clinical trial. this is done by performing total hip arthroplasty. it's expected to evaluate the semi-closed loop system's influence on the doctor's emotional tension during the decision making.

Eligibility criteria:
inclusion criteria: * patients with osteoarthritis of the hip undergoing hip arthroplasty with spinal - epidural anesthesia * age \>50 and \<85 years * asa (american society of anesthesiology classification) ii physical status * start of operation no later than 09:00 * signed informed consent form exclusion criteria: * age \ 85 yers * bmi (body mass index) \ 40 kg/m2 * asa i and asa\>ii physical status * history of a bleeding disorder * anemia before surgery hb\<110 g/l * intravascular fluid infusion within 24 hours before study * diabetes mellitus * previous open hip surgery * psychiatric illness (intake of other psychiatric medication than selective serotonin reuptake inhibitors) * alcohol intake 5 u daily * contraindication to spinal - epidural anesthesia * surgery not by project surgeon * start of operation later than 09:00 * atrial fibrillation * narcotic addiction * history of dvt (deep vein thrombosis), thromboembolic complications, acute cardiac insufficiency * participation in the other study
titan spine endoskeleton tt/to study

Conditions: Degenerative Disc Disease, Spondylolisthesis

Summary: this is a prospective, multi-center controlled observational clinical study. all subjects will receive titan endoskeleton tt/to acid etched titanium implant for the planned procedure. each site will have a predetermined bonegraft extender to be used in all enrolled subjects at that site.


Eligibility criteria:
inclusion criteria: 1. be 18-75 years of age, and skeletally mature 2. have clinical and radiological evidence of degenerative disc disease at one or two levels of the lumbar spine between l2-s1. may also have spondylosis, spinal stenosis, or spondylolisthesis at these levels. 3. in the opinion of the treating surgeon, must already be a qualified candidate for lumbar fusion surgery including 6 months of conservative care prior to surgical intervention. 4. psychosocially, mentally and physically able to comply with protocol, post-operative management and follow-up schedule. 5. subject must understand and sign the written informed consent. exclusion criteria: 1. previous history of fusion surgery at the index level(s). 2. clinical, laboratory and/or radiological evidence of back pain secondary to acute or chronic infection, malignancy, other space occupying lesions and metabolic bone demineralization diseases (e.g. osteomalacia, gout, paget's disease etc.) 3. osteoporosis defined as a dexa bone density measurement t score ≤ 2.5 (necessity for dexa scan will be determined by investigator's standard of care) 4. any terminal or autoimmune disease including but not limited to hiv infection, rheumatoid arthritis or lupus. 5. any other concurrent medical disease that might impair normal healing process. 6. morbid obesity (bmi ≥ 40 kg/m2). 7. investigational drug or device use within 30 days. 8. currently a prisoner. 9. currently experiencing a major mental illness (psychosis, schizophrenia, major affective disorder) which may indicate that the symptoms are psychological rather than of physical origin. -

Keywords: degenerative disc disease, spondylolisthesis
study of meniscal allografts

Conditions: Meniscectomy Sequelae

Summary: total or subtotal meniscectomies in young patients are currently responsible of pain and limitation of activities. there isn't any other treatment than meniscal replacement. but there is no randomized clinical trial on meniscal allograft to validate the efficiency of this treatment.

meniscal allograft is done through united states and europe since the last fifteen years. operative technique has regularly improved, especially because of new arthroscopic devices. the meniscal allografts to be used are taken from dead donors and then frozen according to all the reglementary aspects of tissue bank. the graft has to be ordered as soon as the patient is randomized ; the sizing of the graft ordered is important depending on the gender size and height of the patient and on the measures of the tibial plateau on x rays. the arthroscopic procedure is done under general or loco-regional anesthesia. the graft has to be prepared with bone blocks attached to the anterior and posterior horn of the meniscal graft. these bone blocks will be fixed through bone tunnels and the meniscus itself will be sutured on the peripheral meniscus synovial rim.

Eligibility criteria:
inclusion criteria: * age from 18 on * previous total or subtotal meniscectomy * medical insurance * female patients have to be under contraceptive treatment * sign consent form exclusion criteria: * age \< 18 years * pregnant or breast-feeding woman * need of a simultaneous frontal osteotomy * inflammatory disease * septic background * psychiatric background * understanding difficulties or problems for follow-up * no consent * no medical insurance

Keywords: meniscal allografts osteoarthritis
comparison of two fragmentation modalities in femtosecond laser-assisted cataract surgery

Conditions: Cataract

Summary: femtosecond laser-assisted cataract surgery consists in nuclear lens fragmentation, followed by ultrasound phacoemulsification of nuclear lens, which is then removed. it can be assumed that fragmenting the nuclear lens in more pieces could facilitate the post-laser ultrasound phacoemulsification to extract the lens, with a lesser amount of ultrasonic energy. the decrease of ultrasonic energy delivered during cataract surgery is beneficial to the patient because it optimizes the vitality of corneal endothelial cells, which ensure corneal transparency.


Eligibility criteria:
inclusion criteria: * patient aged ≥ 18 years old * first femtosecond laser-assisted cataract surgery scheduled * cataract density ≥ 3 according to the lens opacities classification system (locs) exclusion criteria: * corneal guttata, uncontrolled glaucoma * shallow depth of anterior chamber * patient's refusal to participate in the study * pregnant or breast feeding patient * patient under legal protection * no health coverage

Keywords: femtosecond laser-assisted cataract surgery nuclear lens fragmentation
study evaluating iv methylnaltrexone for the treatment of post operative ileus

Conditions: Post Operative Bowel Dysfunction

Summary: primary objective: in subjects who have undergone segmental colectomy, the time between the end of surgery and first bowel movement is significantly shorter with the investigational moa-728 regimen than with a placebo regimen.


Eligibility criteria:
inclusion: * must be scheduled for a segmental colectomy via open laparotomy with general anesthesia * subjects with history of inflammatory bowel disease are eligible as long as the disease is not currently active and all other criteria are met * subjects must meet the american society of anesthesiologists physical status i, ii or iii exclusion: * subjects who are scheduled for laparoscopic surgery for the segmental colectomy * subjects with a recent history (\<1 year prior to randomization) of abdominal radiation therapy; subjects with a history of small bowel obstruction, known or suspected bowel adhesions (other than minor, clinically nonsignificant adhesions) * subjects undergoing operations resulting in gastrointestinal ostomies, or who require use of post operative nonsteroidal anti-inflammatory drugs (nsaids)

Keywords: bowel
in vitro correction of thrombin generation by concizumab (anti-tfpi) for severe hemophilia patients

Conditions: Hemophilia

Summary: studies have shown, in haemophilia patients, the effectiveness of anti tfpi antibody (atfpiab) to prevent joint and muscular bleeding (tissues poor in tissue factor (tf)). however, cases of cerebral thrombosis (tissues rich in tf) have been observed in some patients treated with this antibody. because an inter-individual variation in thrombin generation correction by atfpiab, an atfpiab concentration effective at low tf concentration could be at the same time thrombogenic at high tf concentration.

the aim of this study is to determine, for each patient, the minimum concentration of atfpiab necessary to restore thrombin generation in the presence of low (1pm) tf concentration and to evaluate at this concentration of atfpiab a potential thrombogenic effect in the presence of a high (10pm) tf concentration.

Eligibility criteria:
inclusion criteria: * severe or moderate haemophilia a or b patient with fviii or fix \<5% with or without prophylaxis * affiliated or beneficiary of a social security regimen * signature of consent exclusion criteria: * haemophilia patients aged 12 years or less with a weight less than 30 kg (taking into account the volume of blood collection). * patients who received factor viii concentrates less than 48 hours or factor ix concentrates less than 96 hours prior to the routine blood draw at the hemophilia clinic. 96 hours prior to the routine blood draw at the hemophilia centre

Keywords: anti-tfpi antibody thrombin generation tissue factor concentration
f18pet/ct versus tc-mdp scanning to detect bone mets

Conditions: Bone Metastases

Summary: the primary objective is to compare the diagnostic performance of 18f- fluoride pet/ct scanning to that of conventional bone scanning for detecting cancer that has spread to the bone (bone metastasis). the intent of the study is to determine whether 18f-fluoride pet/ct will lead to improved treatment and patient outcomes.

the trial will accrue four hundred-eighty eight (488) evaluable patients with breast cancer, prostate cancer or lung cancer (approximately 163 of each cancer type) referred for routine bone scanning by their respective physicians. the specific stages of cancer required for eligibility are described in the eligibility criteria. approximately eleven to fifteen qualified clinical centers will participate in the trial, with target enrollment for each site set at roughly 40-50 patients per site. the images of the patients will be transmitted to acr image metrix, an imaging contract research organization (icro), for quality assurance and archival. icro will conduct blinded core lab interpretations by 3 radiologists who have not been involved in the design of the trial nor the clinical image interpretation. the data from the core lab readings will be compared with the deliberations of a multidisciplinary panel of oncology experts who will be blinded to the initial scan results and will determine the standard of evidence (truth) for each patient. the analysis will be based on this comparison.

Eligibility criteria:
inclusion criteria: * patient is ≥ 18 years old at the time of the drug administration (patient may be male or female of any race / ethnicity.) * patient or patient's legally acceptable representative cognitively provides written informed consent * patients without known bone metastases who are newly diagnosed with ≥ stage 3 breast cancer, ≥ stage 3 lung cancer, or ≥ stage 2 prostate cancer (and/or psa \>10 micrograms/l), including patient with recurrent breast, lung or prostate cancer * patient is scheduled to undergo a conventional bone scan * patient is capable of complying with study procedures * patient is able to remain still for duration of imaging procedure (about one hour) * patient may have had a prior pet or pet/ct scan for staging/restaging. exclusion criteria: * patient is \< 18 years old at the time of the drug administration * patient is pregnant or nursing; * testing on site at the institution (urine or serum ßhcg) within 24 hours prior to the start of investigational product administration * obtaining surgical history (e.g., tubal ligation or hysterectomy) * confirming the subject is post menopausal, with a minimum 1 year without menses * patient has any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete good quality data * patient has known bone metastases * patient has previously received \[18f\]naf in the last thirty days

Keywords: bone metastasis bone metastases sodium fluoride f18 fluoride bone scan
spironolactone safety in dialysis patients

Conditions: End Stage Renal Disease; Congestive Heart Failure

Summary: cardiovascular disease is the leading cause of death and disproportionately prevalent in patients with kidney disease. spironolactone has been shown to improve survival in the general population with heart failure by up to 30%. we wish to study the safety and tolerability of aldosterone blockade with spironolactone on cardiac function in a high risk population of patients on hemodialysis. we will study and closely monitor subjects over a period of 12 months, during which they will be receiving spironolactone for a period of 6 months.


Eligibility criteria:
inclusion criteria: * they must be at least 18 years of age. * they must understand the study purpose and give their written informed consent. * they must have been stable on chronic hemodialysis for at least three months before enrollment into the study. * hemodialysis subjects will be included if they have had a left ventricular ejection fraction measured within the past six months with a value no more than 45 percent. a repeat, standardized echocardiogram will be used to confirm left ventricular ejection fraction. exclusion criteria: * subjects with primary operable valvular heart disease. * subjects with a congenital heart disease. * subjects with unstable angina. * subjects with primary hepatic failure. * subjects with active cancer or any life-threatening disease (other than heart failure or end-stage renal disease). * subjects who have undergone heart transplantation or who are awaiting heart transplantation are also ineligible. * subjects on a renal transplant list will be accepted into the study until the time of successful renal transplantation and termination of dialysis. * subjects with habitually difficult to control hyperkalemia (serum potassium \>6.0 meq/l) in the previous month while on dialysis will be excluded. * the inability to complete the 6-minute walk test will not be a reason to exclude subjects from this study.