Kornimate/medical-research-clean huggingface dataset:
a study of safety and efficacy in mk-0954a combination in participants with hypertension (mk-0954a-373 am3)

Conditions: Hypertension

Summary: this study is being conducted to evaluate the safety and antihypertensive efficacy of mk-0954a (losartan 50 mg / hydrochlorothiazide (hctz) 12.5 mg) in participants with mild to moderate essential hypertension.


Eligibility criteria:
inclusion criteria: * participant will have reached the legal age by the time of entrance into the run-in period. * participant has no active medical problem, other than essential hypertension, which might of itself or by this treatment significantly affect the participant's blood pressure. - participants diagnosed with mild to moderate essential hypertension or hypertension accompanying with established cardiovascular (cv) and renal diseases who are receiving antihypertensive regimen (exclude diuretic), yet not attaining to treatment goal\*. \* note: for essential hypertension, the goal is to reduce the blood pressure to less than 140/90. for hypertension with established cv and renal diseases, the bp goal is \< 130/80. (according to 2007 european society of hypertension (esh) - european society of cardiology (esc) guideline) * participant is either receiving antihypertensive therapy or no treatment. * participants with stable diabetes mellitus may enter the study. exclusion criteria: * pregnant or lactating females. * secondary hypertension of any etiology (such as unilateral or bilateral renal disease, renal artery stenosis, coarctation of the aorta, pheochromocytoma). * history of malignant hypertension. * sitting systolic blood pressure \>210 mmhg at visit 1 (day 0). * participants with unresolved cerebrovascular accident or transient ischemic attack in the acute stage at visit 1. * a clinically confirmed myocardial infarction within the recent 3 months. * angina pectoris. * clinically important cardiac arrhythmia. * history of unexplained syncope within the prior 2 years, or a known syncopal disorder. - presence of hemodynamically significant obstructive valvular disease of cardiomyopathy. * percutaneous coronary angioplasty or coronary artery bypass surgery within the prior 3 months of visit 1. * participant with a single functioning kidney.

Keywords: hypertension
the effect of high pco2 solution on esophageal acid sensation

Conditions: Gastroesophageal Reflux Disease

Summary: to determine the effect of intraesophageal high pco2 solution as compared to acidic and saline solutions on subjects' heartburn sensation using stiumlus-response functions.

presently, the exact mechanism of gerd and the role of co2 in pathogenesis of heartburn symptoms is unclear. co2 conversion to protons may play a key role in the mechanism for heartburn sensation. this is a prospective, randomized study that will help further explore the mechanism for heartburn sensation in gerd patients and can be a prelude for further studies examining the role of new class antireflux agents such as carbonic anhydrase inhibitors in the treatment of patients with heartburn.

Eligibility criteria:
inclusion criteria: 10 healthy controls * normal egd, normal 24-hr ph * 18-80 years of age * able to read, understand and complete study questionnaires and diary * able to understand study procedures and sign informed consent * albe to comply with all study requirements 10 nerd (non-erosive reflux disease) * 18-80 years of age * willing to stop ppi/h2 blocker prior to egd * have heartburn symptoms 2+ times per week for at least 3 months. exclusion criteria: * esophageal erosions, barretts, or peptic stricture on egd * previous esophageal, gastric or duodenal surgery * underlying co-morbidities * diabetes mellitus (requires insulin), scleroderms, or neuromuscular disorder * upper airway symptoms * tricyclic antidepressants, antispasmodics, selective serotonin receptor inhibitors, thiazides, bile acid-binding agents or prokinetics * patients who cannot or are unwilling to sign icf

Keywords: gerd heartburn acid reflux
effect of amnion membrane with and without taurine on gcf tnf α level.

Conditions: Periodontitis

Summary: 45 sites in 15 patients with periodontal pockets ≥ 5mm were selected. these selected sites were divided into 3 groups as group a, b and c.

group a (control): 15 sites received only srp, group b: 15 sites received srp with subgingival placement of amnion membrane, group c: 15 sites received srp with subgingival placement of amnion membrane hydrated with taurine.

Eligibility criteria:
inclusion criteria: •systemically healthy patients with sites showing probing depth (pd) ≥ 5mm, clinical attachment level (cal) ≥ 4 mm, and vertical bone loss ≥ 3 mm on intraoral periapical radiographs with no history of periodontal therapy or use of antibiotics in the preceding 6 months exclusion criteria: * any systemic disease that could influence the outcome of periodontal therapy. * smokers, alcoholics \& patients with other adverse habits. * pregnant or nursing women. * any known allergy or hypersensitivity to any product used in the study. * patients on long term systemic therapy (antibiotics, anti-inflammatory and any other).

Keywords: periodontitis taurine amnion membrane
a trial to learn how well regn9933 works for preventing blood clots after knee replacement surgery in adult participants

Conditions: Venous Thromboembolism

Summary: the primary objective of the study is to evaluate the efficacy of regn9933 for the prevention of venous thromboembolism (vte) after unilateral total knee arthroplasty (tka), compared to enoxaparin the secondary objectives of the study are: * to evaluate the bleeding risk (ie, major and clinically relevant non-major \[crnm\] bleeding) of regn9933 after unilateral tka through time of venography, compared to enoxaparin * to assess overall safety and tolerability of regn9933 in participants undergoing tka * to evaluate the efficacy of regn9933 in prevention of clinically relevant vte, compared to enoxaparin * to evaluate the efficacy of regn9933 in prevention of deep venous thrombosis (dvt) detected by venography, compared to enoxaparin * to evaluate the pharmacokinetics (pk) of regn9933 after single intravenous (iv) administration * to assess pharmacodynamic (pd) effects of regn9933 on intrinsic and extrinsic coagulation pathways * to assess immunogenicity following a single dose of regn9933 over time * to compare the efficacy of enoxaparin and apixaban in prevention of vte after unilateral tka


Eligibility criteria:
key inclusion criteria: 1. undergoing elective unilateral tka 2. has a body weight ≤130 kg at screening visit 3. is judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, and electrocardiograms (ecg) performed at screening and/or prior to administration of initial dose of study drug 4. is in good health based on laboratory safety testing obtained during the screening period as described in the protocol key exclusion criteria: 1. history of bleeding in the past 6 months requiring hospitalization or transfusion; history of intracranial or intraocular bleeding, excessive operative or post-operative bleeding, and traumatic spinal or epidural anesthesia; history of bleeding diathesis. 2. history of thromboembolic disease or thrombophilia 3. history of major surgery, including brain, spinal, or ocular, within approximately the past 6 months. 4. history of major trauma within approximately the past 6 months. 5. hospitalized (\>24 hours) for any reason within 30 days of the screening visit 6. using the modification of diet in renal disease equation, has an estimated glomerular filtration rate as described in the protocol note: other protocol-defined inclusion/ exclusion criteria apply

Keywords: anti-factor xi (fxi) monoclonal antibody deep vein thrombosis unilateral total knee arthroplasty (tka),
study to evaluate the efficacy and safety of biib074 in neuropathic pain from lumbosacral radiculopathy

Conditions: Lumbosacral Radiculopathy

Summary: the primary objective of the study is to evaluate the efficacy of two dose regimens of biib074 on neuropathic pain in participants with pain from lumbosacral radiculopathy (plsr). secondary objectives are to evaluate the efficacy of 2 dose regimens of biib074 on additional neuropathic pain measures and assessments of low back pain, disability, and quality of life; to investigate the safety and tolerability of 2 dose regimens of biib074 and to characterize the pharmacokinetics (pk) of biib074 in this population.

this study was previously posted by convergence pharmaceuticals, ltd., which has been acquired by biogen.

Eligibility criteria:
key inclusion criteria: * has body weight ≥50 kg for men and ≥45 kg for women * must have diagnosis of neuropathic plsr * has duration of neuropathic (leg) pain of at least 6 months before screening * has an intensity of ≥4 and ≤9 on the numerical rating scale based on a paper-based question at screening and on day 1 that asks for the average pain intensity of neuropathic (leg) pain due to plsr over the last week key exclusion criteria: * has planned surgical intervention for plsr within the duration of the study. (subjects with persistent radicular pain after prior surgery are eligible.) * has a history of peripheral neuropathy (e.g., due to diabetes, alcohol consumption, other causes, or idiopathic) or evidence of peripheral neuropathy upon neurological examination * has a history or risk of seizures or a history of epilepsy, clinically significant head injury, or related neurological disorders note: other protocol-defined inclusion/exclusion criteria may apply.
intraoperative tap block after repeat cesarean

Conditions: Post-operative Pain

Summary: the aim of this study is to perform a randomized trial to investigate if intraoperative surgeon administered tap block reduces pain and use of oral and parenteral pain medications after repeat cesarean delivery. the investigators aim to compare surgeon administered tap block with liposomal bupivacaine compared to standard treatment (i.e. no tap block) with regard to the primary outcome of post-operative narcotic use.

transversus abdominis plane (tap) block is a well-described technique to provide a field block for analgesia. it has been shown to be effective in postoperative analgesia after cesarean delivery. tap blocks are commonly performed post-operatively by anesthesiologists using liposomal bupivacaine with ultrasound guidance. liposomal bupivacaine is an fda approved medication for post-surgical analgesia and available at umass-memorial medical center. liposomal bupivacaine provides sustained release of medication for up to 120 hours. a recent multicenter randomized controlled trial demonstrated the efficacy of anesthesiologist administered tap blocks using liposomal bupivacaine after cesarean delivery. infiltration of the skin and fascia with liposomal bupivacaine after cesarean did not have an effect and this can be explained by the path that the pain fibers take through the tap which makes them amenable to a tap block while a superficial infiltration is ineffective.the aim of this study is to perform a randomized trial to investigate if intraoperative surgeon administered tap block reduces pain and use of oral and parenteral pain medications after repeat cesarean delivery. the investigators aim to compare surgeon administered tap block with liposomal bupivacaine compared to standard treatment (i.e. no tap block) with regard to the primary outcome of post-operative narcotic use.

Eligibility criteria:
inclusion criteria: * pregnant women presenting for elective repeat cesarean delivery at 37-42 weeks gestational age. * pregnancy and delivery care obtained at umass memorial medical center * patients able to provide written informed consent * english, spanish, or portuguese-speaking patients exclusion criteria: * participants who are under the age of 18 years * active labor. * baseline pain score \> 6. * unable to provide informed consent. * prisoners will be excluded from this research. * narcotic use in the 2 weeks prior to delivery. * active substance abuse. * inability to take narcotic analgesia.

Keywords: cesarean delivery, post-operative pain, tap block
office, home, and ambulatory blood pressure

Conditions: Elevated Blood Pressure

Summary: this will be a prospective observational study. the population would be pediatric patients 6 years to \<19 years of age who were referred for elevated blood pressure to investigate if home blood pressure (hbp) can determine blood pressure phenotype (normotensive, hypertensive, masked hypertension, white coat hypertension) as accurately as ambulatory blood pressure monitor (abpm) in childhood and adolescence.


Eligibility criteria:
inclusion criteria: 1. age 6 years to \<19 years old; 2. elevated blood pressure defined as 15% lower than the 95%ile bp based on clinical practice guidelines(cpg) but less than stage ii hypertension based on cpg; 3. tolerate abpm 24 hours; 4. tolerate hbp; and 5. can have diabetes mellitus, obstructive sleep apnea, and attention deficit hyperactivity disorder managed by medication. 6. on stable doses of medications known to affect bp such as: 1. corticosteroids 2. calcineurin inhibitors 3. oral decongestants; 7. clinically stable exclusion criteria: 1. on antihypertension medications or treated in the last 6 months; 2. pregnant; 3. structural heart disease such as: 1. obstructive valvular disease 2. coarctation of the aorta 3. cardiomyopathy; 4. other secondary causes such as: 1. renal artery stenosis 2. neurological condition with dysautonomia; 5. recent initiation of medications known to affect bp such as: 1. corticosteroids 2. calcineurin inhibitors 3. oral decongestants;
enhancing treatment of hoarding disorder with personalized in-home sorting and decluttering practice

Conditions: Hoarding Disorder; Hoarding; Clutter

Summary: the proposed study aims to investigate the efficacy of adding in-home decluttering practice to buried in treasures workshop (bit) facilitated group treatment for hoarding disorder.

patients participate in buried in treasures workshop (bit) that has been shown to improve symptoms of hoarding disorder. the investigators hypothesize that adding in-home decluttering practice to the bit workshop will decrease hoarding symptoms and level of clutter over time.

Eligibility criteria:
inclusion criteria for individuals with hoarding disorder: 1. age 18 to 70 years 2. either gender and all ethno-racial groups 3. physically healthy male or non-pregnant female. 4. hoarding disorder primary condition 5. willing and able to understand and complete consent and study procedures 6. english speaking exclusion criteria for individuals with hoarding disorder: 1. current or past history of bipolar, psychotic or eating disorders, substance dependence, or substance abuse in the last year. 2. clinically at risk of suicide with columbia suicide severity rating scale (c-ssrs) suicidal ideation subscale of 4 or higher (i.e. suicidal intent without specific plan) 3. major medical or neurological conditions that increase the risk of participation or that would prevent completing assigned behavioral practice tasks. 4. unable or unwilling to allow study staff into home for home assessment 5. currently at high risk for eviction 6. animal hoarding or squalor inclusion criteria for healthy controls: 1. age 18 to 70 years 2. either gender and all ethno-racial groups 3. physically healthy male or non-pregnant female. 4. willing and able to understand and complete consent and study procedures 5. english speaking exclusion criteria for healthy controls: 1. any current or lifetime psychiatric diagnosis 2. current or past use of psychotropic medication 3. major medical or neurological problem (e.g., unstable hypertension, seizure disorder, head trauma) 4. metal in body or any other contraindication for mri

Keywords: hoarding disorder hoarding clutter
14.0- 3.0- 3.0- η protein with rheumatoid arthritis

Conditions: Disease Activity

Summary: aim of work: to explore the potential association between serum 14.0-3.0-3.0- η protein level with disease activity and bone mineral density (bmd) in egyptian patients with rheumatoid arthritis (ra). 188 patients with ra and 192 matched controls were enrolled. the ra activity parameters were evaluated in ra patients. bmd was measured. serum level of 14.0- 3.0- 3.0- η protein and il_.6 were estimated for all participants by elisa.

a total of 200 ra patients were invited to be enrolled in this study. patients were diagnosed as having ra by the 2010 european-league-against-rheumatism- (eular) and american-college-of-rheumatology (acr) classification criteria for ra. patients were collected from the outpatient clinic of the rheumatology and rehabilitation department, mansoura university hospital. all participants underwent detailed medical history taking as well as clinical examination. the medical records of all patients were carefully reviewed. data collection included age, gender, past medical history, current and past drug intake. in ra patients, the disease duration, duration of the morning stiffness, tender joint count (tjc) and swollen joint count (sjc) were reported. the activity of ra was measured by disease activity score 28 (das.28) based on the erythrocyte sedimentation rate (esr) level (das28-esr) \[19\]. the intensity of perceived pain was assessed by the visual analog scale (vas) 100-mm scale. bone mineral density (bmd) was measured using dual energy x-ray absorptiometry (dexa) at proximal femur for all participants who were categorized into normal, osteopenic, or osteoporotic according to the definition of the world health organization (who) of the recorded t score a commercially available human il_.6 elisa kit (genprobe, diaclone, france) was used to measure il_.6 serum level following the instructions of the manufacturer. serum level of 14.0- 3.0- 3.0- η protein was determined by elisa for all participants,

Eligibility criteria:
inclusion criteria: * patients were diagnosed as having ra by the 2010 european-league-against-rheumatism- (eular) and american-college-of-rheumatology (acr) classification criteria for ra patients were collected from the outpatient clinic of the rheumatology and rehabilitation department, mansoura university hospital exclusion criteria: * postmenopausal females, patients with other rheumatic autoimmune diseases, severe infection, diabetes mellitus, hypertension, liver or kidney disease, malignancies, endocrinal diseases, pregnant or lactating females. patients with current intake of glucocorticoids, anticonvulsants, estrogen or anti-coagulant, alcohol users, or other factors that lead to secondary osteoporosis were also excluded from the study

Keywords: rheumatoid arthritis osteoporosis 14.0- 3.0- 3.0- η
a randomized, controlled study of repeat dose sustained release lidocaine for treatment of chronic scrotal pain

Conditions: Chronic Pain

Summary: this multi-center, phase 2, randomized, single-blind, three-arm, active-controlled study is comparing repeat doses, every 28 days, of standard of care (soc) plus st-01 against soc plus 1% lidocaine hcl in men experiencing chronic scrotal content pain (cscp). the main purpose of this study is to determine if repeat injections of st-01 are safe and effective in reducing pain. after completing a screening phase participants will be randomized into one of three groups: 1) st-01 70 mg/ml arm, 2) st-01 140 mg/ml arm, 3) 1% lidocaine hcl arm (control). participants may receive up to 4 study treatment injections given at a minimum of 28-day intervals. participants randomized to the control arm will be given the opportunity to cross over to an st-01 treatment arm after 2 study treatments.


Eligibility criteria:
inclusion criteria: 1. adult (≥ 19 years) male 2. unilateral or bilateral scrotal pain lasting \> 3 months 3. have nociceptive scrotal pain 4. average daily maximum scrotal pain score over 7 days ≥ 4 on the 0-10 nrs (appendix 2). participants with bilateral scrotal pain must be able to distinguish one side with pain score ≥ 4 and the opposite side must have a maximum scrotal pain score of ≤ 3.0 at baseline. 5. positive response to test spermatic cord block with 1% lidocaine (lidocaine hydrochloride injection, usp, 1%, 10 mg/ml), defined as a decrease in pain score of at least 2 within 1 hour of injection 6. baseline blood levels without clinically significant abnormalities including liver function tests (alanine aminotransferase \[alt\], aspartate aminotransferase \[ast\], gamma-glutamyl transferase \[ggt\], and alkaline phosphatase \[alp\]) no greater than 50% above the upper limit of normal 7. if sexually active, is willing to use adequate birth control methods to prevent pregnancy over the course of the study exclusion criteria: 1. negative response to test spermatic cord block, defined as absence of a decrease in pain score of at least 2 within an hour of injection 2. other pain generator site with nrs pain score ≥ 4 that interferes with evaluation of scrotal pain 3. history of allergic reaction to lidocaine or any component of st-01 4. any contraindication to local anesthesia with lidocaine (e.g., known hypersensitivity to anesthetics of the amide type; hypokalemia, complete heart block, anticoagulants (aspirin permitted), antiarrhythmic medication.) 5. active infection involving the urinary tract or scrotum 6. inability to give consent 7. inability to follow up according to the protocol 8. negative response to previous spermatic cord block 9. any other condition that the investigator believes may interfere with the safety of the participant, study conduct, or interpretation of the data.

Keywords: chronic scrotal content pain chronic testicular pain chronic scrotal pain orchialgia spermatic cord
pcosmic trial - polycystic ovary syndrome, metformin for infertility with clomiphene

Conditions: Polycystic Ovary Syndrome

Summary: 1. metformin increases the pregnancy rate when added to the standard treatment of anovulatory polycystic ovary syndrome (pcos). 2. metformin in combination with clomiphene, is more effective than clomiphene alone or metformin alone improves fertility outcomes in women with pcos of reasonably healthy body weight (bmi \</= 32). 3. metformin improves fertility outcomes in women with bmi \> 32 with pcos.


Eligibility criteria:
inclusion criteria: * women between the age of 18 and 39 years inclusive. * anovulatory infertility of duration at least 12 months. * polycystic ovary syndrome, based on rotterdam consensus criteria. * normal serum prolactin, thyroid function and 17-hydroxyprogesterone. * normal serum prolactin, thyroid function and 17-hydroxyprogesterone; exclusion criteria: * presence of any other significant infertility factor including male factor, known tubal disease or history of an ectopic pregnancy, known endometriosis affecting the fallopian tubes or ovaries. * already taking oral hypoglycaemics. * diabetics receiving treatment. * renal impairment * chronic hepatic disease * cardiac disease * alcohol dependency * pre-disposition to lactic acidosis * previous ovarian drilling procedure, gonadotrophin injection therapy, iui (intrauterine insemination) or ivf ( in vitro fertilisation). * for those women who have had previous fertility treatment, the following would be excluded: * women who have had \> 5 cycles of clomiphene citrate * women who have had \> 5 months metformin treatment previously * women who have proven to be resistant to 100mg or more of clomiphene citrate.

Keywords: polycystic ovary syndrome pcos anovulation infertility anovulatory polycystic ovary syndrome (pcos)