Kornimate/medical-research-clean huggingface dataset:
bioequivalence study of torrent pharmaceuticals ltd.'s fluoxetine tablets under fed conditions

Conditions: Healthy Subjects

Summary: subjects to compare the single dose bioavailability of torrent's fluoxetine tablets 20 mg and sarafem® 20 mg tablets of warner chilcott llc, usa. dosing periods of studies were separated by a washout period of 35 days.

an open label, randomized, 2-period, 2- treatment, 2-sequence, crossover, single-dose bioequivalence study of fluoxetine tablets containing fluoxetine 20 mg ( test formulation, torrent pharmaceutical ltd., india) versus sarafem® 20 mg tablets containing fluoxetine 20 mg (reference, warner chilcott llc, usa) in healthy human volunteers under fed condition.

Eligibility criteria:
inclusion criteria: * sex: male * age: 18-45 years (inclusive both) * volunteer with bmi of 18.5-27 (inclusive both) kg/m2 with minimum of 50 kg weight. * healthy and willing to participate in the study. * volunteer willing to provide written informed consent. * non-smokers or smoker who smokes less than 10 cigarettes per day. exclusion criteria: * inability to communicate or co-operate. * volunteers suffering from any chronic illness such as arthritis, asthma etc. * history of pre-existing bleeding disorder. * clinically relevant abnormalities in the results of the laboratory screening evaluation. * clinically significant abnormal ecg or chest x-ray. * hiv, hcv, hbsag positive volunteers. * history of significant blood loss due to any reason, including blood donation in the past 3 months. * participation in any study within past 3 months, * history of alcohol or drug abuse. * history of consumption of prescribed medication since last 14days or otc medication/ herbal remedies since last 7 days before beginning of the study. positive to breath alcohol test. * positive to breath alcohol test. * volunteer found to be positive for opiate, tetra hydrocannabinol, amphetamine, barbiturates, benzodiazepines, cocaine positive volunteers based on urine test. * systolic blood pressure less than 100 mmhg or more than 139 mmhg and diastolic blood pressure less than 60 mm hg or more than 89 mm hg. * pulse rate less than 60/minute or more than 100/minute. * oral temperature less than 95°f or more than 98.9°f. * respiratory rate less than 10/minute or more than 20/minute. * history of allergy to the test drug or any drug chemically similar to the drug under investigation. * recent history of kidney or liver dysfunction. * volunteers suffering from any psychiatric (acute or chronic) disorder. * existence of any surgical or medical condition, which, in the judgment of the chief investigator and/or clinical investigator/physician, might interfere with the absorption; distribution,· metabolism or excretion of the drug or likely to compromise the safety of volunteers.
tacrolimus versus clobetasol propionate in the treatment of vulvar lichen sclerosus

Conditions: Vulvar Lichen Sclerosus

Summary: lichen sclerosus is an inflammatory skin condition affecting mostly the genital area of persons of all ages, gender or race. the most frequent complaint is that of itchiness of the vulva but pain may also occur. some women will experience no symptoms at all. however, it is important to treat this condition since it may increase and cause important scarring and deformity. in less than 5% of cases, cancer may develop. lichen sclerosus is a chronic disease which can be controlled but not cured. topical corticosteroids are the usual treatment for this condition. though this treatment is generally well tolerated, some patients may not present a sufficient response or may develop mainly local and rarely systemic side effects. in this perspective, an alternative treatment would be beneficial. tacrolimus, a topical immunomodulator has been approved for the treatment of atopic eczema and has shown its efficacy in the treatment of vulvar lichen sclerosus in a limited number of patients. tacrolimus acts as a non-steroidal anti-inflammatory agent (nsai) without causing the usual side effects seen with the prolonged use of topical corticosteroids. this study is designed to evaluate the safety and efficacy of tacrolimus in treating vulvar lichen sclerosus by comparing it with the standard topical corticosteroid treatment.


Eligibility criteria:
inclusion criteria: * female, 2 years or older * medical diagnosis of vulvar lichen sclerosus * received no treatment during the last 4 weeks exclusion criteria: * who have received topical steroids, tacrolimus or pimecrolimus during the 4 last weeks. * who are immunocompromised * who have history of intra-epithelial neoplasia or anogenital carcinoma * who have active vulvar infections (herpes,condylomas,vaginitis) * who are hypersensitive to tacrolimus, pimecrolimus or corticosteroids * who have physical limitations that cause difficulty in applying the cream * who wear diapers * who present hyperkeratotic vulvar lichen sclerosus

Keywords: female urogenital disease skin disease
a study on the effect of vemurafenib on the pharmacokinetics of a single dose of tizanidine in patients with brafv600 mutation-positive metastatic malignancies

Conditions: Malignant Melanoma, Neoplasms

Summary: this open-label, multicenter, 3-period, fixed-sequence study will evaluate the effect of multiple oral doses of vemurafenib on the pharmacokinetics of a single oral dose of tizanidine in participants with brafv600 mutation-positive metastatic malignancies. participants will receive a single oral dose of tizanidine on day 1, vemurafenib orally twice daily on days 2 to 21, and tizanidine and vemurafenib on day 22. eligible participants will have the option to continue treatment with vemurafenib as part of an extension study (nct01739764).


Eligibility criteria:
inclusion criteria: * adults 18 to 70 years of age, inclusive * unresectable stage iiic or iv metastatic melanoma positive for the brafv600 mutation or other malignant tumor type which harbors a v600 activating mutation of braf, as determined by cobas 4800 brafv600 mutation test or a dna sequencing method * eastern cooperative oncology group (ecog) performance status 0 to 2 * life expectancy greater than or equal to (\>/=) 12 weeks * participant has not consumed tobacco or nicotine-containing products for 42 days prior to first dose of study drug, and must agree to refrain from such products while on study * adequate hematologic, renal and liver function exclusion criteria: * prior treatment with vemurafenib or other braf inhibitor within 42 days of day 1 * history of or current clinically significant cardiac or pulmonary dysfunction, including current uncontrolled grade \>/= 2 hypertension or unstable angina * current dyspnea at rest due to complications of advanced malignancy or any requirement for supplemental oxygen * active central nervous system lesions (participants with radiographically unstable, symptomatic lesions) * participants with cyp1a2 gene mutation (-3113g-\>a), either in one or two alleles * allergy or hypersensitivity to vemurafenib or tizanidine formulations * current severe uncontrolled systemic disease * inability or unwillingness to swallow pills * history of malabsorption or other condition that would interfere with enteral absorption of study treatment * history of clinically significant liver disease (including cirrhosis), current alcohol abuse, or human immunodeficiency (hiv) infection requiring antiretroviral treatment, acquired immune deficiency syndrome (aids)-related illness, or active hepatitis b or c * pregnant or breastfeeding women
ai-guided tips procedure

Conditions: Portal Hypertension Related to Cirrhosis

Summary: the goal of this clinical trial is to learn if transjugular intrahepatic portosystemic shunt (tips)-guided ai model can guide tips procedure in adults better than conventional tips procedure (artificially blinded tips). tips surgical outcomes and intraoperative and postoperative complications will also be observed. the main questions it aims to answer are: * does the ai model lower the number of punctures, radiation dose, and complications of participants undergo tips? * does the ai model improve the efficacy of tips for participants? participants will: * take the tips by the guidance of the ai model or conventional manually blinded penetration (placebo) * the number of punctures, the success rate of the procedure, the radiation dose, intraoperative complications and postoperative complications within 3 months will be recorded * intraoperative portal pressure gradient drop values, symptoms of ascites and rebleeding within 3 months after tips will be reported


Eligibility criteria:
inclusion criteria: * participants who require transjugular intrahepatic portosystemic shunt (tips) and meet the clinical indications for the procedure. * participants whose physical condition is suitable for tips. exclusion criteria: * participants with a history of allergy or serious adverse reactions to iodine contrast media or other related drugs. * participants are pregnant or breastfeeding. * participants are unwilling or unable to sign informed consent.

Keywords: tips ai efficacy complications
communication bridge pilot study

Conditions: Primary Progressive Aphasia

Summary: the aim of this study is to evaluate the effectiveness and feasibility of evidence-based interventions in individuals living with mild to moderate primary progressive aphasia (ppa) that address communication-focused outcomes.

the purpose of this study is to evaluate the effectiveness and feasibility of evidence-based interventions in individuals living with mild to moderate primary progressive aphasia (ppa) that address communication-focused outcomes. the study team aims to enhance the personal relevance and therapeutic impact of goal attainment scaling (gas) while building self-efficacy within a self-management framework. this study will be a continuation of one of the largest non-pharmacologic intervention studies for individuals with ppa to date. it will add critical information regarding the effectiveness of telepractice interventions for communication disorders in adults with primary progressive aphasia specifically, and in dementia more broadly. the goal of this study is to maximize functional communication and life participation for the participants.

Eligibility criteria:
inclusion criteria (person with ppa): 1. meets diagnostic criteria for ppa based on neurologist and supporting medical assessments (extracted from medical records) 2. english as primary language used in daily communication activities (by self-report) 3. adequate hearing (aided or unaided) for communicating with others in a crowded room (by self-report) 4. adequate vision (aided or unaided) for reading a newspaper, or other functional materials (by self-report) 5. able to pass technology screening and demonstrates sufficient knowledge for use of video conference and communication bridge™ web application use (with or without training) 6. geriatric depression scale score ≤ 9 7. mild-moderate ppa informed by a structured interview with a speech-language pathologist and a standardized testing battery. inclusion criteria (co-enrolled communication partner): 1. 18+ years of age 2. english as primary language used in daily communication activities (by self-report) 3. adequate hearing (aided or unaided) for communicating with others in a crowded room (by self-report) 4. able to pass technology screening\* and demonstrates sufficient knowledge for use of video conference and communication bridge™ web application use (with or without training) exclusion criteria: * a dementia diagnosis other than primary progressive aphasia * participation is co-enrolled in an outside speech language therapy program during the study course. * communication partners will be excluded if they have a pre-existing communication impairment that would affect study participation (e.g., aphasia, dementia) medical records will be requested and reviewed to determine eligibility

Keywords: aphasia dementia communication frontotemporal dementia alzheimer disease
optimal placement duration of pancreatic duct stent

Conditions: Cholangitis; Post-ERCP Acute Pancreatitis; Stent Dislodgement

Summary: a randomized controlled trial to determine the optimal placement duration of pancreatic duct stents (pds) inserted during ercp: 2 vs 4 weeks

endoscopic pancreatic duct stenting has been increasingly used for the treatment of a variety of pancreatic disorders including chronic pancreatitis, pancreatic duct stricture, drainage of pseudocysts, and the prevention of pancreatitis following endoscopic retrograde cholangiopancreatography (ercp). several randomized, controlled trials and meta-analyses have proven a significant reduction in incidence and severity of post-ercp pancreatitis (pep) with prophylactic pancreatic duct stenting. the us and european guidelines recommend that pancreatic duct stents (pds) be placed between 7-10 days and 5-10 days, respectively, in order to prevent pep in some situations. therefore, the placement of pds has been an established essential procedure for preventing a fatal complication, pep. furthermore, pds placement can facilitate difficult common bile duct cannulation. it may help not only to straighten papillary anatomy but also to identify the location of the biliary orifice. however, pds tends to become occluded easily due to protein content, calcium carbonate crystals, and bacteria in the pancreatic juice. the occluded pds can cause acute pancreatitis or abdominal pain. for this reason, the guidelines recommend pds be placed within 10 days. because of this policy, the patient must take the inconvenience of undergoing another endoscopic procedure to remove the pds. however, all patients with occluded pds do not have symptoms such as pain. in one series, only 6 percent of patients with clogged pds developed symptoms. the low incidence of symptoms despite a high rate of stent occlusion suggests that the stent may function as a wick around which pancreatic juices continue to drain. in addition, the rate of spontaneous stent dislodgement was relatively high (65-86%) within 30 days according to a previous study. a recent study also reported that prolonged retention of prophylactic pancreatic stents is not associated with increased complications. taken together, pds placed during ercp do not need to be removed until any symptom develops. in particular, if the investigators can observe pds for about a month without removing them, the pds are more likely to pass out spontaneously, which could reduce unnecessary procedures. however, to date, there have been few randomized controlled studies on the optimal placement duration of pds inserted during ercp.

Eligibility criteria:
inclusion criteria: * patients who underwent the pancreatic duct stent placement during ercp exclusion criteria: * patients who had pancreatic duct stent for the purpose of pancreatic interventions * patients who underwent simultaneous bile duct stenting
treatment of polydrug-using opiate dependents during withdrawal

Conditions: Opiate Dependence; Drug Dependence; Substance Withdrawal Syndrome

Summary: managed detoxification is a first and necessary step prior to treatment and rehabilitation. detoxification can be a major obstacle for some patients, and the availability of managed and safe withdrawal is a prerequisite for long-term treatment. in our clinical practice we have felt the need for a standardised and safe detoxification treatment regimen for our opioid addicts, as dependence on multiple drugs is so common. objectives 1. to assess whether a novel standardised treatment regimen - buprenorphine (bpn) combined with valproate (vpa) - will result in fewer withdrawal symptoms during detoxification of opiate-polydrug users than the existing treatment regimen, i.e. clonidine (cln) combined with carbamazepine (cbz). 2. to determine whether there are differences in treatment retention between the bpn/vpa and the cln/cbz groups. 3. to assess differences in clinical side-effects and biochemical interactions between the two treatment regimens.


Eligibility criteria:
inclusion criteria: - polydrug dependency (at least opiate and benzodiazepine dependency) exclusion criteria: * no severe psychiatric illness * no history of epilepsy seizures * no pregnancy or breastfeeding * fertile women must use contraceptives

Keywords: opiate dependence benzodiazepine dependence polydrug abuse detoxification withdrawal treatment
low frequency ultrasound for osteoarthritis healing and rehabilitation

Conditions: Osteo Arthritis Knee; Age Related Osteoporosis; Pain; Knee Joint Contracture

Summary: the purpose of this study is to determine the safety and effectiveness (how well it works) of a new experimental ultrasound bath device that uses low frequency ultrasound (lfu) that may or may not help healing.

this initial study is a pilot study which is going to test the safety and efficacy of the developed ultrasound intervention for osteoarthritis, initially on osteoarthritis of the knee. this study is a pilot study to evaluate two distinct variables. the first is the safety and efficacy of the device, and the second is the potential impact the device may have on patients as their osteoarthritic joints react to the lfu, using patient-reported outcomes associated with this study. the ultrasound will be delivered at a frequency of 33 khz at power levels of 4-10 pascals with a program of 1.6 seconds on and 1.6 seconds off. the generators will be encased in epoxy within the osteoarthritis baths. the intervention will be repeated on every second or third day to allow time for healing

Eligibility criteria:
inclusion criteria: 1. subject has provided informed consent in a manner approved by the irb and is willing and able to comply with the trial procedures. 2. adults at least ≥40 years of age at the time of consent. 3. chronic knee pain within the past 6 months. exclusion criteria: 1. any other arthritic condition clinically classified under acr guidelines as different from an osteoarthritic disorder. 2. any medical condition that, in the opinion of the investigator, would place the subject at increased risk for participation. 3. history of replacement surgery, acupuncture therapy on the joint/knee under study within the past 6 months, or systemic corticosteroids within the study period and previous 30 days. 4. subject's vitals are unstable or not in range for a safe study visit. 5. history of fecal incontinence. 6. vomiting/diarrheal illness within the past 7 days or at any time during the study. 7. any clinically significant rash or formation of rashes or open sores, boils or infected wounds two weeks prior to or during the study. 8. laboratory evidence of infection or colonization with multidrug resistant pathogens in the past 90 days (eg. vancomycin resistant enterococcus, methicillin-resistant staphylococcus, candida auris, extended- spectrum beta lactamase bacteria) 9. history of prior non-compliance or the presence or history of psychiatric conditions (including drug or alcohol addiction) that would, in the opinion of the investigator, make it difficult for the subject to comply with the study procedures or follow the investigators instructions. 10. females who are pregnant or lactating. 11. inability to comply with study protocol. 12. incarcerated individuals. 13. non-english speaking subjects. 14. participant's weight must be \</= 350 lbs.

Keywords: pain osteo arthritis knee knee ultrasound joint mobility
effects of hatha yoga on chronic neck pain

Conditions: Neck Pain

Summary: hatha yoga is a traditional system of exercises, used in india for the relief of painful condition since centuries and gaining more and more interest in europe and the us. while studies have demonstrated benefits of hatha yoga for patients with chronic low back pain, no studies regarding chronic neck pain are available until now. the purpose of this study is to determine if hatha yoga can ameliorate chronic neck pain and related restrictions.

hatha yoga is a traditional system of exercises, used in india for the relief of painful condition since centuries and gaining more and more interest in europe and the us. the efficacy of hatha yoga for relieving chronic low back pain has been repeatedly demonstrated in clinical trials, while there are no studies in the literature regarding chronic neck pain. the aim of this study is to investigate, whether a 9 weeks-course of hatha yoga reduces subjective pain ratings and disability in patients suffering from chronic neck pain. furthermore, as neck pain patients have been shown to suffer from impaired sensory processing and proprioception, along with restricted range of motion, the study aims to test if hatha yoga can improve these variables. therefore, tests regarding cervicocephalic proprioception, active range of motion and the processing of mechanical, vibration and pain stimuli will be included. 58 patients with chronic nonspecific neck pain will be randomized to either hatha yoga group or control group, receiving information regarding exercises for chronic neck pain. the control group will be offered to take part in a yoga class after the end of the study.

Eligibility criteria:
inclusion criteria: * chronic mechanical neck pain, at least 40 mm on the 100mm visual analog scale. * pain for at least 3 months. exclusion criteria: * radicular symptoms * congenital spine deformity * pregnancy * rheumatic diseases * oncologic diseases * other severe psychiatric or somatic comorbidity * recent invasive or surgical treatment of the spine * regularly yoga practice participation in other studies

Keywords: neck pain yoga proprioception sensory thresholds randomized controlled trial