Kornimate/medical-research-clean huggingface dataset:
bioequivalence study of loratadine / pseudoephedrine sulfate 10/ 240 mg extended-release tablets under fed conditions

Conditions: Healthy

Summary: the objective of this study was to compare the single-dose relative bioavailability of ranbaxy and schering (claritin-d® 24 hour) 10 mg loratadine/240 mg pseudoephedrine sulfate extended-release tablets, in a fully replicated design, under fed conditions.

the study was conducted as an open-label, randomized, single-dose, fully replicated, 4-way crossover study to compare the single-dose relative bioavailability of ranbaxy and schering (claritin_d® 24 hour) 10 mg loratadine/240 mg pseudoephedrine sulfate extended-release tablets, in healthy adult volunteers under fed conditions in each period, subjects were housed from the evenings before the dosing until after the 36 hour blood draw and were to return for subsequent blood draws at 48, 72, 96 and 120 hours post dose. single oral 10 mg loratadine/ 240 mg pseudoephedrine sulfate doses were separated by a washout period of 21 days. a total of 40 subjects and 1 alternate (34 males and 7 females) were included in this study, of which 37 (32 males and 5 females) finished the study according to the protocol.

Eligibility criteria:
inclusion criteria: * healthy adult male or female volunteers, 18-45 years of agestart of the study. * other birth control methods may be deemed acceptable * postmenopausal women with amenorrhea for at least 2 years will be eligible * voluntarily consent to participate in the study exclusion criteria: * history or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease * in addition, history or presence of: * alcoholism or drug abuse within the past year * hypersensitivity or idiosyncratic reaction to loratadine or any other h1-receptor antagonist * hypersensitivity or idiosyncratic reaction to pseudoephedrine or any other sympathomimetic amines * glaucoma or hypermetropia * subjects receiving a monoamine oxidase (mao) inhibitor or within 14 days of stopping use of an mao inhibitor, or any sympathomimetic amines * subjects who have used any drugs or other substances known to be strong inhibitors of cyp (cytochrome p450) enzymes within 10 days of study start * subjects who have used any drugs or other substances known to be strong inducers of cyp (cytochrome p450) enzymes within 28 days of study start * female subjects who are pregnant or lactating * subjects who have been on an abnormal diet (for whatever reason) during the 28 days prior to the first dose * subjects who, through completion of the study, would have donated in excess of: * 500 ml of blood in 14 days * 500-750 ml of blood in 14 days (unless approved by the principal investigator) * 1000 ml of blood in 90 days * 1250 ml of blood in 120 days * 1500 ml of blood in 180 days * 2000 ml of blood in 270 days * 2500 ml of blood in 1 days * subjects who have participated in another clinical trial within 28 days prior to the study start

Keywords: bioequivalence 10 mg loratadine 240 mg pseudoephedrine sulfate extended release tablets
volume responsiveness assesment after propofol.

Conditions: Circulatory Failure; Fluid Volume Disorder; Critical Illness

Summary: patients in icu who suffer from circulatory insufficiency, regardless the cause that require invasive hemodynamic monitoring. the aim of the study is to correlate stroke volume variation which predicts fluid responsiveness with change of the blood pressure after intravenous admission of propofol. this test could become a surrogate of stroke volume variation in patients with contraindications to minimally invasive hemodynamic monitoring.

this prospective, observational study was conducted after approval of the independent bioethics commitee at medical university of gdańsk (numer zgody) and registered in clinicaltrials.gov. mechanically ventilated patients of intensive care unit who routinely recieved haemodynamic monitoring with picco™ (getinge ab, sweden) technology using philips intellivue picco-module (philips healthcare, amsterdam, netherlands), were enrolled. patients were sedated with midazolam infusion at 0,15 to 0,6 mg kg-1 h-1 . before the trial in each patient, heart rate (hr) invasive (ibp) and non - invasive blood pressure, (nibp) infusion rate of catecholamines and non adrenergic vasopressors was recorded and picco device was callibrated by transpulmonary thermodilution with 20 ml of cold saline. global end diastolic volume (gedv), intrathoracic blood volume (itbv) and stroke volume variation (svv) were calculated and recorded. for effective ventilation with increased tidal volume of 8 ml kg-1 of predicted body weight, each patient recieved propofol bolus of 0,25 mg kg-1, 0,5 mg kg-1 and 1,0 mg kg-1 consecutively. higher doses were used at good tolerance of the lower ones. after each bolus systolic and diastolic invasive blood pressure, heart rate (hr), continuous cardiac output (cco), continuous cardiac index (cci), stroke volume index (si), stroke volume variantion (svv), and left ventricular contractility index (dpmax) were recorded every fifteen seconds for ten minutes. the absolute and realtive change in blood pressure, compared to the values of blood pressure before the drug administration, were correlated with svv. time interval between each examination ranged from 4 to 48 hours.

Eligibility criteria:
inclusion criteria: icu patient haemodynamically instable mechanically ventilated exclusion criteria: simultaneous propofol infusion contraindications for propofol atrial fibrillation valvular malfunction aortic stenosis aortic aneurysm
acute effects of kinesiology taping in handball players

Conditions: Kinesiology Taping

Summary: the aim of this randomised placebo-controlled study was to investigate the acute effect of kinesiology taping in the gastro-soleus muscle group of handball players. researchers compared the placebo and the kinesiology taping groups to see if there were any effects on foot plantar and dorsiflexion muscle strength, balance, proprioception, horizontal jumping and injury proneness.

this randomised placebo-controlled and double blinded study aimed to investigate the acute effect of kinesiology taping in the gastro-soleus muscle group, which has the key role in jumping, of handball players on foot plantar and dorsiflexion muscle strength, balance, proprioception, horizontal jumping and injury proneness. there were two groups in the study: the experimental group was applied 'y shaped' kinesiology taping on gastro-soleus muscle group, based on facilitation technique with 25-50% stretching. the control (placebo) group was applied kinesiology taping on gastro-soleus muscle group without any stretching. participants' muscle strength, proprioception, balance, horizontal jumping and injury proneness was measured before and two hours after taping.

Eligibility criteria:
inclusion criteria: * licensed handball player * volunteer to participate the study exclusion criteria: * any discomfort that is contraindicated for the measurements * have suffered any injury in the last 6 months

Keywords: muscle strength proprioception handball players
the evaluation of the toffee mask for the treatment of obstructive sleep apnea

Conditions: Obstructive Sleep Apnea

Summary: this investigation is a prospective, non-randomized, non-blinded study. this investigation is designed to evaluate the performance, comfort and ease of use of the f\&p toffee mask amongst obstructive sleep apnea (osa) patients. up to 45 osa patients will be recruited from the pulmonary disease specialists research database.

visit 1 will involve the participants being consented into the trial. visit 2 will involve the participants being fitted with the f\&p toffee mask for use in home. the participant will then come in to return the mask (visit three) and have a final interview, this ensures the maximum time participants will be exposed to the toffee mask in home will be 14 ± 4 days from visit two. the mask will be returned to the institution at the conclusion of the trial and the participant will return to their previous mask. the institution will recruit all patients within 2 weeks of the beginning of the study.

Eligibility criteria:
inclusion criteria: * adult (22+ years of age) * able to give informed consent * apnea hypopnea index (ahi) ≥ 5 on diagnostic night * either prescribed automatic positive airway pressure (apap), continuous positive airway pressure (cpap) or bi-level positive airway pressure (pap) for osa * fluent in spoken and written english * existing osa mask user exclusion criteria: * inability to give informed consent * participant intolerant to pap * anatomical or physiological conditions making pap therapy inappropriate * current diagnosis of respiratory disease or carbon dioxide (co2) retention * pregnant or may think they are pregnant.
safety and efficacy of intravenous magnesium sulfate in modulating changes in symptoms and divalent cation levels associated with foscavir therapy: a phase iv randomized, double-blind, placebo-controlled, cross-over, pilot study

Conditions: Cytomegalovirus Infections; HIV Infections; Hypocalcemia

Summary: to determine whether acute ionized hypomagnesemia and hypocalcemia immediately following foscarnet infusions can be lessened or eliminated by prior infusion of magnesium sulfate. to determine whether reductions in ionized magnesium, ionized calcium, and parathyroid hormone levels following foscarnet infusions are lessened by preinfusion of magnesium sulfate. to evaluate the safety of intravenous magnesium sulfate prior to foscarnet infusion by monitoring blood pressure, heart rate, and heart rhythm. to characterize the effect of magnesium sulfate on foscarnet blood levels and urinary excretion of calcium, magnesium, phosphate, and foscarnet.

patients are randomized to one of four treatment groups. intravenous foscarnet is administered for 4 days. patients receive one of three doses of magnesium sulfate or placebo in normal saline according to one of four schedules. sequence of doses will differ for each group.

Eligibility criteria:
inclusion criteria patients must have: * aids by cdc criteria. * documented cmv disease. * tolerance of foscarnet dose of 90 mg/kg bid. * normal serum calcium, serum creatinine, and serum phosphate. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * known allergy to foscarnet. * in extremis or incapacitated because of underlying illness (e.g., comatose or tracheally intubated). * volume depletion. concurrent medication: excluded: * nephrotoxic drugs such as iv pentamidine, amphotericin b, aminoglycosides, and cisplatin. * other investigational drugs that affect metabolic balance, such as human growth hormone. * oral or parenteral magnesium and calcium supplementation. patients with the following prior condition are excluded: history of heart block.

Keywords: infusions, intravenous foscarnet cytomegalovirus infections acquired immunodeficiency syndrome magnesium sulfate magnesium deficiency hypocalcemia
a phase 2 study to evaluate the safety and efficacy of vx-135 with ribavirin in treatment-naïve subjects with chronic hepatitis c

Conditions: Chronic Hepatitis C

Summary: a phase 2 study to evaluate the safety and efficacy of two different once daily doses vx-135 in combination with ribavirin in treatment-naïve subjects with chronic hepatitis c


Eligibility criteria:
key inclusion criteria: * subjects (male and female) must be between the ages of 18 and 60 years at screening * subjects must have genotype 1 chronic hepatitis c * subjects must be treatment naïve * subjects must have laboratory values at screening within limits as specified by the protocol key exclusion criteria: * evidence of cirrhosis * female subjects who are pregnant or nursing or male subjects with a female partner of childbearing potential who is unwilling to adhere to the contraception requirements, is pregnant or nursing, or planning to become pregnant during the study * any other cause of significant liver disease in addition to hepatitis c * human immunodeficiency virus -1 or -2 * diagnosis of or suspected hepatocellular carcinoma * history of organ transplant, with the exception of corneal transplants and skin grafts

Keywords: chronic hepatitis c hcv chc
study to determine incidence of hypoventilation in patients who have undergone gastric bypass

Conditions: Morbid Obesity; Bariatric Surgery

Summary: the purpose of this study is to determine if gastric bypass patients experience hypoventilation in the immediate postoperative period, and to what degree.

we propose to determine if patients with clinically significant obesity (body mass index, bmi, between 40 kg/m2 and 85 kg/m2), who have undergone gastric bypass procedures under general anesthesia hypoventilate during the initial twenty-four hour postoperative period, and if so, to what degree. adequacy of ventilation will be assessed by serial arterial blood analyses. patients will be monitored for spo2 in the preoperative holding area, in the operating room, and the post-anesthesia care unit (pacu) by conventional and study pulse oximeters. spo2 data will be collected continuously and recorded on the study pulse oximeter for the entire study period. arterial blood samples will be drawn for analysis every four hours by in-dwelling arterial catheter, using standard sterile technique. hypoventilation is defined as an increase in paco2 five or more mm hg above patient's baseline.

Eligibility criteria:
inclusion criteria: * male and female subjects 18 to 65 years of age * clinically significant obesity with a bmi between 40 and 85 * candidates approved for gastric bypass surgery at tampa general hospital (\*please note: authorization for gastric bypass will be completed prior to enrollment in study; this study does not pay for the cost of the operation.) * american society of anesthesiologists (asa) physical status classification i-iii * able to understand and sign informed consent exclusion criteria: * patients not able to understand the informed consent process, or unable to understand the research protocol * patients in which placing an arterial catheter would pose a clinically unacceptable health risk, e.g., bleeding disorders, radial artery malformation
long-term safety and efficacy of momelotinib in subjects with primary myelofibrosis, post-polycythemia vera myelofibrosis, post-essential thrombocythemia myelofibrosis, polycythemia vera or essential thrombocythemia

Conditions: Primary Myelofibrosis; Post-Polycythemia Vera Myelofibrosis; Post-Essential Thrombocythemia Myelofibrosis; Polycythemia Vera; Essential Thrombocythemia

Summary: this open-label study is to determine the long-term safety and tolerability of momelotinib in previously enrolled study participants with primary myelofibrosis (pmf), post-polycythemia vera myelofibrosis (post-pv mf), post-essential thrombocythemia myelofibrosis (post-et mf), polycythemia vera (pv), or essential thrombocythemia (et), who have tolerated and achieved stable disease or better with momelotinib treatment while enrolled in a previous clinical trial.


Eligibility criteria:
key inclusion criteria: * currently enrolled in study ccl09101e, or ym387-ii-02, or successfully completed 24 weeks of study gs-us-352-1672 * able to comprehend and willing to sign informed consent form key exclusion criteria: * known hypersensitivity to momelotinib, its metabolites, or formulation excipients note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: primary myelofibrosis post polycythemia vera myelofibrosis post essential thrombocythemia myelofibrosis polycythemia vera essential thrombocythemia blood disorders
perspectives on end-of-life care for medically-fragile children and young adults

Conditions: Death

Summary: hattie larlham is a specialized long-term care facility for pediatric and young adult residents who are medically fragile and intellectually disabled, whose daily care is provided by direct care staff, habilitation assistants (ha), in conjunction with nurses and other direct care providers. the purpose of this study is to assess the perspectives of ha and parents/legal guardians on end-of-life care in a long-term care facility for pediatric and young adult residents who are medically fragile and intellectually disabled.


Eligibility criteria:
inclusion criteria: * ha at hattie larlham between january 1, 2006 to present * ha provided care to \> 1 resident whose death occurred between january 1, 2006 through the end of the study period * ha provided ongoing care to the resident for at least 5 days in the last 30 days at hattie larlham before the resident's death * parent/legal guardian of a hattie larlham resident whose death occurred between january 1, 2006 through the end of the study exclusion criteria: * ha employed \< 30 days at hattie larlham or cared for resident \<5 days in last 30 days prior to the resident's death * ha or parent/legal guardian who has not experienced a hattie larlham resident's death since december 31, 2005

Keywords: parents medically fragile death end-of-life care surveys
prevention of diabetes mellitus development in women who had already experienced a gestational diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: gestational diabetes is also a strong risk factor for the development of diabetes mellitus at a later stage of life in previous gdm woman. among all the risk factors of diabetes mellitus, the experience of gestational diabetes is the strongest one. the incidence of various forms of diabetes in this group balances from 10 to 60% over a period from 2 to 10 years. the aim of this study is a comparison of the efficacy of life style modification and life style modification in conjunction with metformin administration, in a population of women, who had already experienced gestational diabetes.

gestational diabetes mellitus (gdm) is one of the most frequent metabolic disorders occurring during pregnancy that complicates both, the course of pregnancy and the delivery and is also responsible for many fetal complications. gestational diabetes is also a strong risk factor for the development of diabetes mellitus at a later stage of life in previous gdm woman. among all the risk factors of diabetes mellitus, the experience of gestational diabetes is the strongest one. the incidence of various forms of diabetes in this group balances from 10 to 60% over a period from 2 to 10 years. presently, in the literature, there are described new, more efficient methods of diabetes prevention in groups with a high risk of this disorder, which involve both, a modification of the life style and pharmacotherapy. the use of metformin in patients with a impaired glucose tolerance, resulted in a ca. 30% reduction of the diabetes incidence rate. the aim of this study is a comparison of the efficacy of life style modification and life style modification in conjunction with metformin administration, in a population of women, who had already experienced gestational diabetes.

Eligibility criteria:
inclusion criteria: * gdm - experienced during pregnancy (diagnosis of gdm according to who-criteria) * breast-feeding of the newborn finished (lactation finished) * actual bmi \>= 25 kg/ m2 * written consent for participation in the study * a hitherto prevailing good cooperation with the patient exclusion criteria: * cholestasis during the past pregnancy * any hepatic diseases in the past (viral hepatitis, toxic hepatic damage,jaundice of unknown etiology) * serum aspat and/or alat level exceeding more than twice normal laboratory values * pregnancy planned during the coming two years * presence of contradictions for metformin administration according to demands of the drug admission committee in poland

Keywords: metformin gestational diabetes lifestyle
multi-centre study to assess long-term safety and efficacy of the silent™ hip prosthesis in primary thr

Conditions: Osteoarthritis

Summary: the purpose of this study is to determine if the silent™ hip is effective in the treatment of patients with hip joint disease requiring a total hip replacement. patients who enter the study will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments. a subset of patients will undergo scans to allow the bone mineral density of the bone surrounding the implant to be monitored

the purpose of this study is to determine if the silent™ hip, when used as part of an artificial hip joint, is effective in the treatment of patients with hip joint disease requiring a total hip replacement. patients who enter the study will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments. a subset of patients will undergo scans to allow the bone mineral density of the bone surrounding the implant to be monitored

Eligibility criteria:
inclusion criteria: * male or female subjects, aged 18 years or above at the point of screening for participation. * subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained. * subjects who, in the opinion of the clinical investigator, are able to understand this clinical investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-treatment follow-ups. * subjects with non-inflammatory osteoarthritis of the hip who require a primary total hip replacement and are considered suitable for a cementless femoral and acetabular component. exclusion criteria: * subjects who, in the opinion of the investigator, have an existing condition that would compromise their participation and follow-up in this study. * women who are pregnant. * subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes. * subjects who have participated in a clinical study with an investigational product in the last 6 months. this exclusion does not apply to those subjects who are participating in the pilot investigation of the depuy silent hip (ct01/27) * subjects who are currently involved in any injury litigation claims. * subjects who have osteonecrosis of the femoral neck * subjects with significant bone loss or gross deformity in the region of the neck of the femur as identified on the pre-operative radiographs, where in the investigator's opinion, there could be considerable migration of the depuy silent hip or a significant chance of fracture of the femoral shaft and/or the lack of adequate bone to support the depuy silent hip. * subjects with a charnley c classification. * subjects with an active local or systemic infection. * subjects with loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the arthroplasty procedure unjustified. * subjects with paget's disease

Keywords: hip cementless conservative
study of nivolumab in subjects with relapsed or refractory follicular lymphoma (fl) (checkmate 140)

Conditions: Lymphoma

Summary: the purpose of this study is to assess the clinical benefit of nivolumab, as measured by independent radiologic review committee (irrc)-assessed objective response rate (orr) in subjects with fl lymphoma who have failed therapy with both cd20 antibody and an alkylating agent.


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * grade 1, 2, or 3a fl without pathologic evidence of transformation * male and female, ages 18 and above, with relapsed or refractory fl lymphoma after \> or =2 prior treatment lines; each of the 2 prior treatment lines must include at least cd20 antibody and/or an alkylating agent * eastern cooperative oncology group (ecog) performance status (ps) 0-1 exclusion criteria: * known central nervous system lymphoma * history of interstitial lung disease * subjects with active, known or suspected autoimmune disease * prior allogeneic stem cell transplant * prior autologous stem cell transplant ≤12 weeks prior to first dose of study drug