Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the efficacy and the change of sag levels in chronic hepatitis b patients receiving clevudine treatment over the long period

Conditions: Chronic Hepatitis B

Summary: the purpose of this study is to evaluate the efficacy and the change of sag levels in chronic hepatitis b patients receiving clevudine treatment over the long period.


Eligibility criteria:
inclusion criteria: 1. patient is 18 years and older. 2. patient is documented to be hbsag positive for \> 6 months and hbv dna positive. 3. patient is hbeag positive or negative. 4. patient has alt levels ≥ 80 iu/l 5. patient who is able to give written informed consent prior to study start and to comply with the study requirements. exclusion criteria: 1. patient is currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy. 2. patients previously treated with interferon within the previous 3 months. 3. patients previously treated with clevudine, lamivudine, adefovir, entecavir, telbivudine or any other investigational nucleoside for hbv infection. 4. patient is coinfected with hcv, hdv or hiv. 5. patient is pregnant or breast-feeding. 6. patient has a clinically relevant history of abuse of alcohol or drugs. 7. patient has a significant immunocompromised, gastrointestinal, renal, hematological, psychiatric, bronchopulmonary, biliary diseases excluding asymptomatic gb stone, neurological, cardiac, oncologic(except hcc)or allergic disease or medical illness that in the investigator's opinion might interfere with therapy. 8. patient has creatinine clearance less than 60ml/min as estimated by the following formula: (140-age in years) (body weight \[kg\])/(72) (serum creatinine \[mg/dl\]) \[note: multiply estimates by 0.85 for women\]
trial to evaluate the efficacy and safety of cipro® xr in treating female patients with lower urinary tract infections

Conditions: Urinary Tract Infection

Summary: this trial evaluated how effective and safe cipro xr was in treating female patients with signs and symptoms of a lower urinary tract infections. after 3 days of treatment, patients were evaluated to determine if signs/symptoms disappeared and the infecting bacteria was eliminated.


Eligibility criteria:
inclusion criteria: * non-pregnant, non-lactating female outpatients between the ages of 18 - 44 years (inclusive) * patients with at least two of the following clinical signs and symptoms of an uuti: * dysuria * frequency * urgency * suprapubic pain * patients with onset of symptoms \< 72 hours prior to study entry * patients with one positive pre-treatment clean-catch midstream urine culture at enrollment in the study, defined as \> 10000 cfu/ml (study drug treatment is permitted prior to the availability of urine culture results) * positive leukocyte esterase (le) (1+ or greater) utilizing a urine dipstick method of analysis * patients willing to give written informed consent * cultures must be performed on pre-treatment clean-catch midstream urine (msu) specimens exclusion criteria: * males * women who are pregnant, nursing, or not using two medically accepted, effective methods of birth control * patients with known or suspected hypersensitivity to quinolones * patients unable to take oral medication for any reason * patients with an asymptomatic bacteriuria * patients with complicated uti, defined as: a clinical syndrome characterized by the development of systemic and local signs and symptoms of fever (\> 38.3°c/101°f orally), chills, malaise, flank pain, back pain, or costovertebral angle (cva) pain or tenderness * symptoms as outlined in the inclusion criteria occurring in the presence of a functional or anatomical abnormality of the urinary tract or in the presence of urinary catheterization * patients with symptoms of a uti within the 4 weeks prior to the present episode * patients with the onset of symptoms \>72 hours prior to study entry * patients with three or more episodes of any uti in the past 12 months * patients with evidence of factors predisposing to the development of utis, including calculi, stricture, primary renal disease (e.g. polycystic renal disease), or neurogenic bladder * patients who received systemic antimicrobial therapy within 48 hours prior to entry * patients with a neutrophil count \< 1000/mm3, cd4 \< 200/mm3 or other conditions associated with significant depression in host defense; hiv testing is not mandatory * patients requiring concomitant systemic antibacterial therapy with agents not specified in this protocol * patients with a previous history of tendinopathy associated with fluoroquinolones * patients diagnosed with a rapidly fatal underlying disease (death expected within six months) * patients requiring concomitant use of theophylline * patients previously enrolled in this clinical study * patients taking an investigational drug in the last 30 days

Keywords: uti urinary tract infection
study of avutometinib (vs-6766) + adagrasib in kras g12c nsclc patients

Conditions: Non Small Cell Lung Cancer; KRAS Activating Mutation; Advanced Cancer; Metastatic Cancer; Malignant Neoplasm of Lung; Malignant Neoplastic Disease

Summary: this study will assess the safety and efficacy of avutometinib (vs-6766) in combination with adagrasib in patients with g12c non-small cell lung cancer (nsclc) who have been exposed to prior g12c inhibitor and experienced progressive disease.

this is a multicenter, non-randomized, open-label phase 1/2 study designed to evaluate safety, tolerability and efficacy of avutometinib (vs-6766) in combination with adagrasib in patients with kras g12c mutant nsclc who have been exposed to prior g12c inhibitor and experienced progressive disease.

Eligibility criteria:
inclusion criteria: * male or female subjects ≥ 18 years of age * histologic or cytologic evidence of nsclc * known kras g12c mutation * the subject must have received prior therapy with a kras g12c inhibitor and experienced progression * must have received appropriate treatment with at least one prior systemic regimen, but no more than 3 prior regimens, for stage 3b-c or 4 nsclc * measurable disease according to recist 1.1 * an eastern cooperative group (ecog) performance status ≤ 1 * adequate organ function * adequate recovery from toxicities related to prior treatments * agreement to use highly effective method of contraceptive exclusion criteria: * prior chemotherapy, targeted therapies, radiotherapy, immunotherapy or treatment with an investigational agent within 14 days of receipt of study drug (within 6 weeks for nitrosoureas, mitomycin c and chest radiation; within 6 months prior to cycle 1 day 1 for chest radiation \> 30gy) * history of prior malignancy, with the exception of curatively treated malignancies * major surgery within 4 weeks (excluding placement of vascular access) * exposure to strong cyp3a4 inhibitors or inducers within 14 days prior to the first dose and during the course of therapy * exposure to strong inhibitors of breast cancer resistance protein (bcrp) within 14 days prior to the first dose and during the course of therapy * symptomatic brain metastases requiring steroids or other local interventions within the 2 weeks prior to initiation of therapy * known sars-cov2 infection ≤28 days prior to first dose of study therapy * known hepatitis b, hepatitis c, or human immunodeficiency virus infection that is active * active skin disorder that has required systemic therapy within the past 1 year * history of rhabdomyolysis or interstitial lung disease * concurrent ocular disorders * concurrent heart disease or severe obstructive pulmonary disease * subjects with the inability to swallow oral medications

Keywords: nsclc kras g12c non small cell lung cancer metastatic cancer adagrasib avutometinib (vs-6766)
evaluating the efficacy of the enav toolkit to improve colorectal cancer screening

Conditions: Colorectal Cancer Screening

Summary: the purpose of this research study is to evaluate the efficacy of a digital navigation tool, called the enav to improve colorectal cancer screening uptake among patients treated at federally qualified health centers (fqhc)s. the digital navigation tool includes a website and text messaging support. the website includes information, motivational support, decisional support and cues to action (e.g., ability to request a crc screening test). the enav tool also includes text-messaging based navigation (e.g., reminders, instructions to complete the screening test).

this is a multi-site randomized clinical trial to evaluate the efficacy of the enav toolkit. a total of 400 participants will be from four fqhc clinics within the institute for family health fqhc network. participants will be randomly assigned to one of two groups: 1. enav group (n=200) or 2. usual care group (n=200) participants will consent and complete a baseline questionnaire (demographics, medical information) 1-4 weeks before their primary care appointment. those in the intervention group will receive a link to the enav website. the digital navigation tool includes a website and text-messaging support. the website includes information, motivational support, decisional support and cues to action (e.g., ability to request a crc screening test). the enav tool also includes text-messaging based navigation (e.g., reminders, instructions to complete the screening test). the control group will receive standard clinical care. then 3-6 weeks after that primary care appointment, the research team will reach out to participants to complete a follow-up questionnaire. the follow up questionnaire will assess constructs guided by the health belief model (e.g., self-efficacy, benefits/barriers for crc screening). the impact of the enav toolkit on crc screening completion at 6 months will be evaluated by checking their medical records. if a patient does not have a crc screening recorded in their medical record, the research team will call the patient to inquire whether they have completed the crc screening.

Eligibility criteria:
inclusion criteria: * patient treated at the institute for family health (ifh) * patient 45 to 75 years old * english or spanish speaking * able to provide consent within the study time frame (within a month of the primary care appointment * patients have access to a computer, tablet or mobile device to access the enav toolkit or willing to use a clinic provided device, in person at either ifh or mount sinai * patient scheduled for a primary care appointment at ifh * patients are due for colorectal cancer screening (as determined by the health maintenance alert in the medical chart) exclusion criteria: * unable to provide informed consent

Keywords: colorectal cancer screening federally qualified health centers digital patient navigation toolkit
safety, efficacy, and tolerability of vilazodone in major depressive disorder

Conditions: Major Depressive Disorder

Summary: the purpose of this study was to further characterize the efficacy, safety, and tolerability of a single fixed dose level of vilazodone compared to placebo in patients with major depressive disorder.


Eligibility criteria:
inclusion criteria: * men and women, 18-70 years of age. * currently meet the diagnostic and statistical manual of mental disorders fourth edition, text revision (dsm-iv-tr) criteria for major depressive disorder. * the patient's current major depressive episode must be at least 8 weeks and no longer than 12 months in duration. exclusion criteria: * women who are pregnant, women who will be breastfeeding during the study, and women of childbearing potential who are not practicing a reliable method of birth control. * patients with a history of meeting dsm-iv-tr criteria for any: * manic, hypomanic or mixed episode, including bipolar disorder and substance-induced manic, hypomanic, or mixed episode; * any depressive episode with psychotic or catatonic features; * panic disorder with or without agoraphobia; * obsessive-compulsive disorder; * schizophrenia, schizoaffective, or other psychotic disorder; * bulimia or anorexia nervosa; * presence of borderline personality disorder or antisocial personality disorder; * mental retardation, dementia, amnesia, or other cognitive disorders; * patients who are considered a suicide risk.

Keywords: major depressive disorder depression
treatment of patients with optic nerve damage patients using electrostimulation

Conditions: Glaucoma; Electrical Stimulation; Home Treatment

Summary: the aim of the present study is to investigate the possibilities of visual field enhancement with electrical stimulation (es) as a home stimulation method, in a total of 50 patients with optical neuropathy, who have already been treated with es in the past. furthermore, factors responsible for response variability and treatment effectiveness are also explored: (i) the role of mental stress (or stress resilience), (ii) the status of biomarkers, such as the systemic stress hormone levels and blood supply to the eye and brain (specifically vascular dysregulation) and (iii) the influence of personality, anxiety, depression and lifestyle. the study serves to further validate this es procedure for the treatment of visual impairment. specifically, better efficacy, better compliance, lowest response variability are expected after long-term home use.


Eligibility criteria:
inclusion criteria: * patients with glaucoma, disease duration at least 6 months * stable visual field defect across baseline measurement (subjects with spontaneous fluctuations and recovery of vision excluded) * presence of residual vision and detectable gradual transition between the intact and the absolutely blind part of the visual field according to evaluation of the clinician * best corrected visual acuity at least 0.4 (20/50 snellen) or better exclusion criteria: * autoimmune diseases in the acute stage * neurological and mental diseases * diabetic retinopathy * addictions * hypertension (maximum 160/100 mmhg) * retinitis pigmentosa- * pathological nystagmus * non-distant tumors or recurrent tumors * photosensitivity * pregnancy * electric or electronic implants (e.g. heart pacemaker) * metal implants in the eyes or head (with the exception of dental prosthesis or shunts)
td-1211 iv/oral mass balance study

Conditions: OIC

Summary: the purpose of this study is to determine td-1211 is processed by the body.

this study will provide information regarding the metabolic pathway of td 1211, the need for evaluation of potential drug-drug interactions, the need for studies in special populations and the absolute oral bioavailability of td-1211. the administration of radiolabeled drug is necessary to fully characterize the rates and routes of elimination of td 1211, providing further quantitative information on the disposition of td 1211. the results from this study will allow a more comprehensive comparison between animal and human routes of elimination and metabolic profiles of td 1211.

Eligibility criteria:
inclusion criteria: 1. healthy, nonsmoking male, 18 to 50 years old, inclusive. 2. agrees to use a highly effective method of birth control. 3. body mass index (bmi) 19 to 30 kg/m2, inclusive, and weighs at least 55 kg. 4. willing and able to give written informed consent. exclusion criteria: 1. evidence or history of clinically significant allergic (except for untreated, asymptomatic, seasonal allergies at time of dosing), hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease. 2. hemoglobin \<14.1 g/dl or hematocrit \< 40.6% at screening. 3. history of hypersensitivity to drugs, or a history of or any current clinically significant hypersensitivities. 4. any condition possibly affecting drug absorption (e.g., previous surgery on the gastrointestinal tract \[including removal of parts of the stomach, bowel, liver, gall bladder, or pancreas\]). 5. participated in another clinical trial of an investigational drug (or medical device) within 60 days (or 5 half-lives of the investigational drug, whichever is longer) prior to screening, or is currently participating in another trial of an investigational drug (or medical device).

Keywords: oic opioid induced constipation constipation
facial gingival level evaluation following soft tissue augmentation using ctg around immediate dental implants vs immediate dental implants alone in the esthetic zone.

Conditions: Immediate Dental Implants Connective Tissue Graft Esthetic Zone

Summary: aim of current study to evaluate connective tissue graft combined with immediate implant placement as an innovative option for less facial gingival tissue recession, less pocket depth and less clinical attachment loss versus immediate implant alone.

p: adult patients with single or multiple non-restorable teeth in esthetic zone i: immediate implant + connective tissue graft. c: immediate implant alone. o: primary outcome: facial gingival level secondary outcome: patient satisfaction, probing depth, probing attachment loss, tissue biotype, keratinized mucosal width and bleeding on probing. p.m will select patients from the outpatient clinic of the oral medicine and periodontology department - cairo university. screening of patients will continue until the target population is achieved. identifying and recruiting potential subjects is achieved through patient database.

Eligibility criteria:
inclusion criteria: 1. 18-55 2. patients with single or multiple non-restorable teeth in maxillary anterior or premolar area. 3. patients with adequate bone volume for the dental implant procedure. 4. patients who are compliant to oral hygiene measures. 5. patient consent approval and signing. exclusion criteria: 1. heavy smokers. 2. systemic disease that contraindicates implant placement or surgical procedures. 3. no or poor patient's compliance. 4. psychological problems. 5. pathology at the site of intervention. 6. pregnancy females.

Keywords: immediate dental implant, connective tissue graft, esthetic zone.
culturally adapted cognitive behavior therapy for psychosis in pakistan

Conditions: Psychosis

Summary: aim: to assess the feasibility of application of culturally-adapted cbt (cacbtp) for use in pakistan. design: randomized control trial setting: psychiatry departments of general hospitals in karachi. participants: a total of 36 patients with a diagnosis of psychotic disorder will be randomized to a psychological intervention or treatment as usual arm. intervention: culturally adapted cognitive behavioral therapy (cbt) outcome measure: positive and negative syndrome scale (panss) psychotic symptoms rating scales (psyrats)

the purpose of the study is to test the feasibility of culturally adaptive cbt for psychosis in pakistan primary : -to assess the feasibility of application of culturally-adapted cbt (cacbtp) for use in pakistan. secondary: * to assess fidelity of culturally-adapted cbt for psychosis. * to further modify cacbtp in accordance with findings of feasibility study the participants will be recruited from psychiatric department of different hospitals.they will be randomly divided into two groups; intervention group and treatment-as-usual group. a total of thirtysix participants will be recruited in the feasibility study and divided equally into two arms. this will ensure that, even after loss to follow-up, the investigators will have at least 12 subjects per group for analysis (fda guidance http://www.fda.gov/cder/guidance/5356fnl.pdf. randomization will be carried out by the on offsite statistician . this will provide a reliable geographically remote service. for intervention group twelve sessions of cacbtp will be delivered by trained research clinician for a period of three months. participants in the treatment as usual (tau) group will be given details of intervention at the end of the study and interested participants will be offered cacbtp.

Eligibility criteria:
inclusion criteria: 1. diagnosis of psychosis established by clinician using icd10 criteria. 2. individuals aged between 18-65. 3. should not have learning disability. 4. resident of karachi. 5. participant is able to give informed written consent exclusion criteria: 1. severe illness which may affect capacity or markedly affect their ability to participate in interview, e.g. very thought disordered or distressed by symptoms. 2. severe drug or alcohol problem (i.e., those who fulfill the criteria for dependence according to icd10 rdc).

Keywords: cbt, psychosis, cultural adaptation, pakistan
the intensive pharmacokinetics sub-study of encore1 (encore1-pk)

Conditions: HIV Infection

Summary: safety and efficacy are key issues in antiretroviral therapy (art) selection. efavirenz (efv) is an important component of combination art in treatment naive individuals. like many drugs, there are inter-individual differences in the efficacy and tolerability of efv. the encore1 study provides an opportunity to examine the pharmacokinetics (pk)(processes by which a drug is absorbed, distributed, metabolized, and eliminated by the body) of efv in blood samples collected over a 24-hour dosing interval in participants receiving either standard 600 mg or reduced 400 mg dose efv once daily.

this sub-study will investigate the relationships between dosage, efv plasma concentrations, toxicity and virological efficacy. efv concentrations in dried blood spots and matched plasma and will be evaluated to determine the utility of dried blood spot measurements in measuring efv plasma concentrations. measurements dried blood spots could potentially be a cheap and easy alternative to measurements in plasma. dried blood spots can be easily collected from venous blood or fingerprick, do not need plasma separation and potentially need less stringent storage conditions during shipment.

Eligibility criteria:
all participants enrolled into the main encore1 study at participating sub-study sites will be eligible to participate. participants must meet the following additional inclusion criteria prior to intensive pharmacokinetic assessment. inclusion criteria: * provide written sub-study consent at or before week 0 * taken randomized study drugs for at least 4 weeks but less than 8 weeks * taken efv in the evening for at least 7 days * taken all efv doses over the 3 preceding days.

Keywords: hiv efavirenz pharmacokinetic