Kornimate/medical-research-clean huggingface dataset:
sofosbuvir + ribavirin for 12 weeks in subjects with chronic genotype 2 or 3 hepatitis c infection who are interferon intolerant, interferon ineligible or unwilling to take interferon

Conditions: Chronic Hepatitis C

Summary: this multicenter study was to evaluate subjects with chronic genotype 2 or 3 hcv infection who were interferon (ifn) ineligible, ifn intolerant or unwilling to take ifn. participants were randomized in a 3:1 ratio to receive sofosbuvir (sof)+ribavirin (rbv), or placebo to match sof+placebo to match rbv. randomization was stratified by presence/absence of cirrhosis. approximately 20% of participants may have had evidence of cirrhosis at screening.

participants who were randomized to the placebo arm and completed all scheduled study procedures were eligible to receive active sof+rbv in open-label study gs-us-334-0109. participants who do not achieve sustained virologic response (svr) were eligible for enrollment in the sequence registry study gs-us-248-0123. the purpose of the sequence registry study is to monitor the persistence of resistant mutations for up to 3 years. participants who achieved svr were eligible for enrollment in the svr registry study gs-us-248-0122. the purpose of the svr registry study is to evaluate durability of svr for up to 3 years after treatment.

Eligibility criteria:
inclusion criteria: * infection with hcv genotype 2 or 3 * cirrhosis determination * subject meets one of the following classifications: 1. ifn unwilling 2. ifn ineligible 3. ifn intolerant * screening laboratory values within defined thresholds * subject has not been treated with any investigational drug or device within 30 days of the screening visit * use of highly effective contraception methods if female of childbearing potential or sexually active male exclusion criteria: * prior exposure to an direct-acting antiviral targeting the hcv nonstructural protein (ns)5b polymerase * pregnant or nursing female or male with pregnant female partner * current or prior history of clinical hepatic decompensation * history of clinically-significant illness or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol * excessive alcohol ingestion or significant drug abuse

Keywords: hcv genotype 2 (gt-2) hcv genotype 3 (gt-3) hcv sustained virologic response direct acting antiviral combination therapy interferon intolerant interferon ineligible gs-7977 ribavirin
intrathecal morphine,femoral nerve block,periarticular bupivacaine infiltration for pain after intramedullary hip screw

Conditions: Femoral Neck Fractures

Summary: falls are a common problem in elderly patients resulting fractured femur, which require early operation. adequate postoperative pain control will provide good recovery. the investigators will compare the efficacy of postoperative pain control among intrathecal morphine, femoral nerve block, and periarticular infiltration with bupivacaine in patients undergone intramedullary hip screw under spinal anesthesia.

study methods : every patients without any exclusion criteria will be performed spinal anesthesia by 0.5% heavy bupivacaine then divided into 4 groups 1. controlled group : spinal anesthesia alone 2. femoral nerve block by 20 ml of 0.25% bupivacaine before spinal anesthesia 3. spinal anesthesia plus 0.1 mg morphine intrathecally 4. spinal anesthesia plus periarticular infiltration with 20 ml of 0.25% bupivacaine all patients will receive postoperative intravenous patient controlled analgesia (iv pca) morphine for 48 hours. data collection 1. demographic data 2. pain score : preoperative, 3 hours postoperative in the 1st six hours, 12 hours postoperative by visual analog scoring system (vass) 3. patient global assessment and patient satisfactory vass at 24 and 48 hours postoperative 4. the amount of morphine at 24 and 48 hours postoperative and the time of the 1st dose

Eligibility criteria:
inclusion criteria: * 18-90 years old * good consciousness, well co-operated, can use pca machine * asa class 1-3 * no contraindication of spinal anesthesia * accept for spinal anesthesia * body weight \> 30 kg * bmi 20-35 kg/m2 * no history of research-drug allergy exclusion criteria: * previous history of hip surgery (the same side) * pathological fractured such as severe infection, bone cancer
achilles tendon rupture - intervention with electrical stimulation

Conditions: Achilles Tendon Ruptures; Immobilization; Venous Thromboembolism (VTE); Muscle Atrophy

Summary: acute achilles tendon rupture (atr) is an injury that is commonly associated with complications, such as blood clotting, muscle loss and tendon lengthening, all of which affect the long-term outcome and return to sports. these complication are related to the treatment of atr with lower leg immobilization in a boot. the investigators aim to demonstrate that an intervention with calf neuromuscular electrical stimulation (c-nmes) during leg immobilization after atr can 1) reduce blood clots, 2) lower the degree of muscle loss, 3) decrease tendon lengthening and 4) improve long-term outcome.

the participants will be divided by chance into two separate groups that compare standard treatment (control group) with c-nmes in addition to standard treatment (intervention group). a total of 220 patients with diagnosed atr will be included. the control group will be treated according to the standard regimen with a lower leg immobilization in a stable orthosis during eight weeks. the intervention group will during the eight weeks lower limb immobilization receive an additional intervention with c-nmes underneath the orthosis. the total number of blood clots, venous thromboembolism incidence, up to mobilization, is defined as deep venous thrombosis (leg blood clots) assessed by screening duplex ultrasound, or pulmonary embolism (lung blood clots). calf muscle loss, tendon length, and weight-bearing, will be studied at two and eight weeks. at six weeks and 12 months, validated self-reported function (atrs) and self-reported health, return to sports, calf muscle function, and tendon length will be recorded for comparison between the two treatment groups. secondary outcomes are coagulation factors, healing biomarkers and cardiovascular biomarkers. the results of this study should contribute to an improved treatment regimen after atr that allows for a safer and quicker return to activity and sports. adjuvant nmes can readily be implemented in daily healthcare to lower complication risks, improve healing, reduce healthcare costs and improve return to sports.

Eligibility criteria:
inclusion criteria: * diagnosed with acute unilateral achilles tendon rupture * included within 10 days after injury. exclusion criteria: * inability to give consent to participate, * ongoing treatment with anticoagulants, * known allergy to contrast agents, * planned follow-up at another hospital, * inability to follow instructions, * known renal failure, * heart failure with pitting edema, * thrombophlebitis, * thromboembolic disease within the last 3 months, * previous surgery of the tendon, * known malignancy, * hemophilia, * pregnancy, * treatment with high doses of acetylsalicylic acid.

Keywords: neuromuscular electrical stimulation duplex ultrasound
distribution of a single iv dose of [124i]-pf 06687234 and pf 06687234 assessed with pet-ct imaging in moderate to severe ulcerative colitis and crohn's disease

Conditions: Inflammatory Bowel Disease

Summary: the purpose of the study is to evaluate the pk, safety and tolerability of pf-06687234 and \[124i\]ib-pf-06687234 (simultaneously given) in subjects with moderate to severe ulcerative colitis or crohn's disease. the study used pet-ct scan imaging to assess the distribution of pf-06687234 and \[124i\]ib-pf-06687234 over 24 and 72 hours in colon (inflamed and non-inflamed), plasma, colon, liver, spleen, kidney and small intestine.


Eligibility criteria:
inclusion criteria: * male and/or female subjects of non-child bearing potential, 18 years to 75 years of age inclusive at the time of informed consent * only women of non-child bearing potential * diagnosis of active uc (histologic) or cd prior to study entry for a minimum of 4 months * subjects with moderate to severe, active uc as defined by mayo endoscopic index of at least 2; or subjects with moderate to severe, active cd as defined by ses-cd score of at least 7. exclusion criteria: * clinically significant/unstable clinical conditions (eg. cancer hematological, endocrine etc) * active enteric infections * other forms of colitis such as infectious colitis etc

Keywords: positron emission tomography (pet), inflammatory bowel disease, safety, pkplasma
global study of del-desiran for the treatment of dm1

Conditions: DM1; Myotonic Dystrophy; Myotonic Dystrophy 1; Myotonia; Myotonic Dystrophy Type 1 (DM1); Dystrophy Myotonic; Myotonic Disorders; Steinert Disease; Steinert; Myotonic Muscular Dystrophy

Summary: a phase 3 randomized, double-blind, placebo-controlled, global study to evaluate the efficacy and safety of intravenous delpacibart etedesiran (abbreviated del-desiran, formerly aoc 1001) for the treatment of myotonic dystrophy type 1

the study consists of a screening period of up to 6 weeks and 54-week treatment period. the anticipated duration is approximately 60 weeks. participants will be randomized to receive an intravenous infusion of either del-desiran or placebo at the clinical study site every 8 weeks for a total of 7 doses. the final dose will occur at week 48, followed by a final assessment at week 54. after completion of week 54 assessments, eligible participants will have the option to enroll into an open label extension (ole) study, pending regulatory approval. an independent data monitoring committee (idmc) comprised of members independent and external to the sponsor will review safety, tolerability, and efficacy (as needed) data of this study at regular intervals.

Eligibility criteria:
key inclusion criteria: * clinical and genetic diagnosis (ctg repeat ≥ 100) of dm1 * ability to walk independently (orthoses and ankle braces allowed) for at least 10 meters at screening key exclusion criteria: * breastfeeding, pregnancy, or intent to become pregnant during the study * unwilling or unable to comply with contraceptive requirements * abnormal lab values, conditions or diseases that would make the participant unsuitable for the study * diabetes that is not adequately controlled * history of decompensated heart failure within 3 months of screening. participants with preexisting pacemaker/icd are not excluded. * body mass index \> 35 kg/m2 at screening * recently treated with an investigational drug or biological agent * treatment with anti-myotonic medication within 5 half-lives or 14 days of baseline, whichever is longer, prior to baseline. note: additional protocol defined inclusion and exclusion criteria apply

Keywords: dm1 myotonic dystrophy myotonic dystrophy 1 myotonia myotonic dystrophy type 1 (dm1) dystrophy myotonic myotonic disorders steinert disease steinert myotonic muscular dystrophy harbor avidity biosciences avidity aoc 1001 del-desiran delpacibart etedesiran
n-acetylcysteine (nac) for children with tourette syndrome

Conditions: Tourettes Syndrome; Tic

Summary: tourette syndrome is a childhood-onset neuropsychiatric disorder characterized by multiple motor and vocal tics that last for at least a year in duration. currently, there exist several effective pharmacological treatments for childhood tics including alpha-2 agonist medications (guanfacine and clonidine) and neuroleptics (antipsychotic) medications. these medications, however, have significant side-effects and are only partially efficacy in treating tics. n-acetylcysteine (nac) is a natural supplement that acts as an antioxidant and glutamate modulating agent. nac has been used safely for decades in doses 20-40 times higher than in this trial as an antidote for acetaminophen overdose. the only side-effect commonly seen with nac is nausea and this side-effect is seldom seen in the doses used in this trial. nac has recently been demonstrated to be effective in a double-blind, placebo-controlled trial in adults with trichotillomania (chronic hair pulling). hairpulling is hypothesized to be closely related to tics because these conditions (1) have similar clinical characteristics -- both groups typically experience urges before engaging in pulling or tics, (2) neuroimaging studies suggest they involve similar brain circuits -- the basal ganglia, (3) the same pharmacological treatments (neuroleptics) may be effective for both conditions and (4) they tend to be inherited together in families. in other trials nac has evidence of some efficacy in treating diverse psychiatric conditions such as bipolar depression, schizophrenia and cocaine dependence. the investigators are conducting this trial to determine if nac is an effective treatment for tics.


Eligibility criteria:
inclusion criteria: * children aged 8-17 years. * primary diagnosis of tourette syndrome or chronic tic disorder. * duration of tics greater than 1 year. * significant current tic symptoms: current ygtss score greater than or equal to 22 with a ts diagnosis or greater than or equal to 14 with a chronic tic disorder. exclusion criteria: * comorbid bipolar disorder, psychotic disorder, substance use disorder, developmental disorder or mental retardation (iq\<70). * recent change (less than 4 weeks) in medications that have potential effects on tic severity (such as neuroleptic medications, dopamine agonists, alpha-2 agonists (guanfacine, clonidine or prazosin), ssris, clomipramine, naltrexone, lithium, psychostimulants, or anxiolytics). medication change is defined to include dose changes or medication discontinuation. * recent change in behavioral treatment for tourette syndrome or comorbid conditions (i.e. ocd) within the last 4 weeks or initiation of behavioral therapy for tics within the last 12 weeks. * asthma requiring medication use within the last 3 months * known hypersensitivity or previous anaphylactoid reaction to acetylcysteine or any components in its preparation * positive pregnancy test or drug screening test. * previous use of n-acetylcysteine (dose greater than 600mg for more than 2 weeks)

Keywords: tic disorders, tourette syndrome chronic tic disorders
nicardipine and labetalol effects on cerebral hemodynamics in preeclampsia

Conditions: Preeclampsia Severe

Summary: realization of transcranial doppler and optic nerve sheath in severe preeclamptic patients to evaluate the impact of nicardipine and labetalol on cerebral hemodynamics.


Eligibility criteria:
inclusion criteria: * aged up to 18 years * patient with severe preeclampsia defined by systolic blood pressure ≥ 140 mmhg and/or diastolic blood pressure ≥ 90 mmhg after 20 weeks of amenorrhea, associated with neurologic troubles, eclampsia of epigastric pain. * decision by clinician to introduce an antihypertensive therapy by oral route : either labetalol or nicardipine exclusion criteria: * history of intracranial expansive processus, surgery or vascular disease * infectious state on probe placement * unilateral anophthalmia
defining volume status with extracellular water measurement in patients with intracranial hemorrhage

Conditions: Intracranial Hemorrhages

Summary: the goal of this observational study is to learn about the influence of extracellular water on volume status in adult patients with intracranial hemorrhage presenting with hemodynamic instability. the main question it aims to answer is: • can measurement of extracellular water contribute to the description of hemodynamic instability in adult patients with intracranial hemorrhage. patients with intracranial hemorrhage admitted to intensive care will receive standard care with the addition of measurement of extracellular water.

adult patients with intracranial hemorrhage admitted to icu will be recruited. during the first five days after inclusion blood samples and extended non-invasive monitoring, including monitoring of the microcirculation (cytocam) and measurement of extracellular water (dielectronic constant), will be added to routine care and monitoring.

Eligibility criteria:
inclusion criteria: * adults with intracranial hemorrhage admitted to icu. exclusion criteria: * pregnancy, palliative care.
neuropsychoanalytic treatment of failed back surgery syndrome-opioid dependence

Conditions: Pain

Summary: opioid dependent patients who have failed back surgery syndrome are detoxified and treated with a neuropsychoanalytic paradigm.

patients were detoxified from opioid analgesics and treated with nsaids and other non-opioid analgesics, received neuropsychoanalytic therapy and low dose naltrexone. patients kept a daily diary of: 0 - 10 pain, 0 - 10 function, hours worked, amount of alcohol drunk, illicit and licit drug use, number of health care provider appointments attended, number of self-help groups meetings attended across each of the six months of study. six month outcomes of this approach with primary outcomes being sobriety, pain scores and function scores.

Eligibility criteria:
inclusion criteria: 1. have failed back surgery syndrome. 2. have evidence of opioid dependence by meeting dsm-iv criteria and by drug abuse screening test \> 4. (in case of a difference in these two measures, clinical staff will talk with the patient to adjudicate the difference.) 3. over 18 4. be able to understand spoken and written english 5. reside within 30 miles of the site of treatment for ease of followup 6. have health insurance or other ability to pay for treatment exclusion criteria: 1. homeless 2. unable to give consent (e.g. neurological disorders, dementia, psychosis) 3. co-occurring incapacitating psychiatric disorder such as schizophrenia 4. pregnant 5. financial incentive to stay ill, such as a pending disability claim 6. member of a vulnerable population, including prisoners
partial maxillary expansion with post grafting expansion vs. pre full maxillary expansion in secondary alveolar cleft

Conditions: Alveolar Cleft

Summary: intermediate grafting with both pre- and post- grafting maxillary expansion with time span after grafting 6-8 weeks for consolidation and final retention for 3 months after finalization of expansion will get the advantages of both techniques combined.

secondary alveolar bone grafting (sabg) is an essential step in the overall management of patients with cleft lip and palate (clp). the numerous advantages of this procedure have been reported in the literature. however, resorption of the bone graft is a common situation, and the success of alveolar bone grafting (abg) depends on several factors . the periodontal health of the surrounding graft tissues, the experience and ability of the surgeon and the timing of surgery are shown to be the most important factors determining success. failure to rehabilitate the alveolar cleft may give rise to a variety of problems, including oronasal fistula, fluid reflux, speech pathology, impaired tooth eruption, lack of bone support for the anterior teeth, dental crowding, periodontal recession and eventual loss of teeth, and maxillary and facial asymmetry . lack of alveolar bone also limits orthodontic treatment and/or prosthodontics rehabilitation. post graft stimulation of maturation through remodeling of the graft is extremely important and is provided primarily by natural tooth eruption. thus, the ideal time period for sabg is shown as to be the mixed dentition stage (9-12 years), just before the eruption of the permanent canine in line with the cleft. timing of maxillary expansion in patients with cleft lip and palate is debated. proponents of expanding the maxilla prior to secondary alveolar bone grafting state it is beneficial to align the segments prior to bone grafting better access for placement of the graft and working facility during surgery, however more recent literature shows maxillary expansion after secondary bone grafting is possible advocates of expansion following grafting cite the advantages that bone consolidation is improved when the graft is placed under a dynamic load during healing and that there is a smaller soft tissue defect to close, less difficulty procuring an adequate volume of bone, and a narrower defect, which will regenerate bone more quickly and less possibility to induce oronasal fistula during maxillary expansion the study will change the concept of alveolar bone grafting in relation to maxillary expansion .just getting 5 mm minimal between two cleft edges and 2/3 of canine or lateral root has been formed and thin bone separate tooth from cleft defect the graft could be done

Eligibility criteria:
inclusion criteria: patients with unilateral cleft alveolus with in the mixed dentition stage no intraoral soft and hard tissue pathology no systemic condition that contraindicate grafting exclusion criteria: * local criteria: * poor oral hygiene * radiation therapy the head and neck cancers systemic criteria: * immunity deficiency or hemorrhagic inherited diseases * bone pathology
efficacy and safety study of jtt-302 in subjects with low hdl-c levels

Conditions: Dyslipidemia

Summary: the purpose of this study is to determine the effect of jtt-302 on the increase of high density lipoprotein-cholesterol (hdl-c) levels when administered daily for four weeks in subjects with low hdl-c levels.


Eligibility criteria:
inclusion criteria: * subjects with a body mass index (bmi)≤ 35 kg/m2 * subjects with the following lipid parameters at visit 1 (screening visit) and visit 3 (diet stabilization period): * hdl-c ≤ 40 mg/dl (men) and ≤ 50 mg/dl (women) * tg ≤ 500 mg/dl * ldl-c ≤ 190 mg/dl * subjects who are generally healthy as determined by pre-study medical history, physical examination, vital signs and 12-lead ecg exclusion criteria: * females who are pregnant or breast-feeding * ast, alt or total bilirubin ≥ 2.0 x uln at visit 1 (screening visit) or visit 3 (diet stabilization period) * serum thyroid stimulating hormone (tsh) and levothyroxine (t4) outside of the central laboratory reference range at the screening visit * medical history of diabetes mellitus or two fasting serum glucose measurements \> 126 mg/dl at the screening visit * subjects with hypertension, or two blood pressure measurements ≥ 140 mm hg systolic or ≥ 90 mm hg diastolic at the screening visit * history of drug or alcohol abuse within 12 months of the screening visit * use of medications defined in the protocol within six-weeks prior to the screening visit and throughout the study * use of cytochrome p450 3a4 inducers or inhibitors, as defined in the protocol within four weeks of the screening visit and throughout the study