Kornimate/medical-research-clean huggingface dataset:
a study of repeat dosing of peg recombinant human coagulation factor viii-fc fusion protein for injection

Conditions: Severe Hemophilia A

Summary: primary objective: to assess the pharmacokinetics, safety and immunogenicity of repeat dosing of peg recombinant human coagulation factor viii-fc fusion protein for injection with severe hemophilia a(frsw117) secondary objectives: to assess preliminary efficacy of repeat dosing of peg recombinant human coagulation factor viii-fc fusion protein for injection with severe hemophilia a.


Eligibility criteria:
key inclusion criteria: * the activity of the coagulation factor viii (fviii:c) \< 1%. * patients previously treated with fviii concentrate (s) for a minimum of 150 exposure days (eds) prior to study entry * normal prothrombin time or inr \< 1.3 * negative lupus anticoagulant key exclusion criteria: * hypersensitive to any of the excipients of the test materials (e.g. allergic to murine or hamster origin heterologous proteins) * history of hypersensitivity or anaphylaxis associated with any fviii or ii immunoglobulin administration * current fviii inhibitor-positive or history of fviii inhibitor-positive * other coagulation disorder(s) in addition to hemophilia a.• significant hepatic or renal impairment (alt and ast \> 2×uln; serum bilirubin level \> 2 × upper limit of normal (uln), urea /bun \> 2×uln, cr \> 176.8 µmol/l) * one or more clinically significant tests for human immunodeficiency virus (hiv), antisyphilitic spirulina (tpha) and hepatitis c virus (hcv) antibody * patients who received any anticoagulant or antiplatelet therapy within one week prior screening or need to receive an anticoagulant or antiplatelet therapy during the period of clinical trials * patients having major surgery or receiving blood or bood components transfusion within 4 weeks prior screening or having planned major surgery schedule during the study * patients who previously participated in the other clinical trials within one month prior screening * any life-threatening disease or condition which, according to the investigator's judgment, could not benefit from the trial participation * patient who is considered by the other investigators not suitable for clinical study other protocol-defined inclusion/exclusion criteria may apply.

Keywords: pharmacokinetics; safety; immunogenicity; preliminary efficacy
assessment of postoperative pain after using various intracanal medication in patients with necrotic pulp

Conditions: Postoperative Pain

Summary: to assess the postoperative pain after using silver nanoparticles with and without calcium hydroxide as an intracanal medication in patients with necrotic pulp (rct)

when the treatment itself appears to initiate the onset of pain and/or swelling, the result can be very distressing to both the patient and the operator. patients might even consider postoperative pain and flare-up as a benchmark against which the clinician's skills are measured. prevalence of postoperative pain or flare-up is, therefore, one of the influencing factors when making a clinical decision. better management of postoperative pain increases the patients' confidence in dentist's skills and gives positive attitude toward dental profession. in cases with necrotic pulp, the incidence of pain becomes higher, hence testing which intracanal medication is more effective in decreasing the bacteria present within the root canal and subsequently pain is crucial.

Eligibility criteria:
inclusion criteria: * patients who are free from any physical or mental handicapping condition with no underlying systemic disease. * non-pregnant females * asymptomatic necrotic mandibular single rooted teeth. * normal occlusal contact with the opposing teeth. * patients accepting to participate in the study. exclusion criteria: * medically compromised patients: pain levels and healing following treatment would be compromised as these patients have shown higher incidence of pain and lower healing rate. * pregnant women: avoid radiation exposure, anesthesia, and medication. * if analgesics or antibiotics have been administrated by the patient during the past 12 hours preoperatively might alter their pain perception * patients reporting bruxism or clenching: avoid further pressure on an already inflamed tooth inducing subsequent irritation and inflammation teeth that shows: * association with acute periapical abscess and swelling: need special treatment steps which could involve additional visits with incision and drainage. also, it could influence initiation and progression of postoperative pain. * greater than grade i mobility or pocket depth greater than 5mm. need special surgical and/or periodontal therapy. * no restorability: hopeless tooth. * vital teeth * immature teeth * radiographic evidence of external or internal root resorption. * any criterion, not mentioned in the inclusion criteria
12-week, double-blind, placebo-controlled, randomized study of the efficacy of 40 mg/day kw-6002 in parkinson's disease patients on levodopa/carbidopa

Conditions: Parkinson's Disease

Summary: 12-week, double-blind, placebo-controlled, multicenter, randomized study designed to evaluate the safety and efficacy of 40 mg/day istradefylline compared with placebo in subjects with off phenomena advanced pd who were treated with levodopa/carbidopa.

a 12-week, double-blind, placebo-controlled, multicenter, randomized study designed to evaluate the safety and efficacy of 40 mg/day istradefylline compared with placebo in subjects with off phenomena advanced pd who were treated with levodopa/carbidopa.

Eligibility criteria:
inclusion criteria: 1. united kingdom parkinson's disease society brain bank diagnostic criteria (step 1 and 2). 2. modified hoehn and yahr scale ii-iv in the off state. 3. treated with levodopa/carbidopa for 1 year with a stable regimen for 4 weeks prior to randomization. 4. taking at least 4 doses of levodopa (3 doses if at least 2 doses containing slow release formulation) per day with predictable end of dose wearing off. 5. successfully completed parkinson's disease patient diary training with at least 120 minutes of off time per day. 6. stable regimen of other antiparkinson's disease medications for at least 4 weeks prior to randomization. 7. at least 30 years of age and able to give written informed consent. exclusion criteria: 1. treatment with liquid levodopa/carbodopa within 4 weeks of randomization. 2. treatment with mao inhibitors except selegiline. 3. treatment with centrally acting dopamine antagonists within 3 months (6 months for depot preparations), e.g., antipsychotic neuroleptics, metoclopramide, buspirone, amoxapine. 4. neurosurgical surgery for parkinson's disease. 5. atypical parkinsonism or secondary parkinsonism variants. 6. diagnosis of cancer or evidence of continued cancer within 5 years of enrollment or clinically significant illness of any organ system (e.g., alt or ast \> 1.5 times the upper limit of normal). 7. mini-mental status examination score of 25 or less. 8. history of drug or alcohol abuse or dependence within 2 years. 9. history of psychotic illness or seizures. 10. current clinically relevant depression disorder. 11. history of neuroleptic malignant syndrome. 12. pregnant or lactating females. women of child-bearing potential must use reliable method of contraception.

Keywords: parkinson's disease levodopa therapy end of dose wearing off off time
prevention of oral mucositis after using chamomile oral cryotherapy versus oral cryotherapy in pediatric cancer patients receiving chemotherapy.

Conditions: Oral Mucositis (Ulcerative) Due to Antineoplastic Therapy

Summary: oral mucositis is a painful situation that significantly affects patients' quality of life with the severe cases being associated with ulcerated mucosa and secondary infection which may lead to life-threatening sepsis.chamomile infusion in cryotherapy was used to aid in reduction of chemotherapy induced mucositis and to enhance the effect of standard cryotherapy alone by its anti-inflammatory, antifungal and antibacterial effect. the occurrence of oral mucositis is a significant complication of chemotherapy with prevalence of up to 80% in pediatric patients.the study is to be conducted at the in and outpatient clinics at the department of pediatric oncology, national cancer institute,egypt. a structured interview questionnaire sheet will be filled with personal, medical and dental history. intraoral examination will be carried out using sterile latex gloves, masks, plain mouth mirrors, sterile gauze and wooden tongue depressor. patients who will agree to participate in the study will watch a video explaining how to perform oral hygiene.preparation of the interventions is done in the clinic with 400 ml of distilled water with or without the infusion of 10 g of chamomile flowers."chamomile classic infusion, royal herbs" .ice cubes will be prepared in special ice trays placed in the chemotherapy center for this purpose.patients will be instructed to swish the ice cubes around their oral cavities starting 5 minutes before chemotherapy infusion, continuing 30 minutes throughout the session and for additional 35 minutes after completion of intravenous chemotherapy session. follow ups are done at the 8th,15th and the 21st day of interventions application.


Eligibility criteria:
inclusion criteria: 1. patients with healthy and intact oral mucosa. 2. patients diagnosed with bone tumor (osteosarcoma) for the first time. 3. patients receiving methotrexate as part of their chemotherapeutic regimen. 4. both male and female patients undergoing chemotherapy at in and out patient units of pediatric oncology department. 5. age of patient ranging (6- 18) years old. 6. legal representatives of patient must be able to read, understand and provide informed consent to participate in the trial. 7. patients with no history of dental discomfort related to cold or hot food or beverage intake. exclusion criteria: 1. administration of antiviral or antifungal therapy and/or any other treatment for oral mucositis before enrollment in the study. 2. presence of advanced or severe periodontitis (pocket depth more than 6mm). 3. patients who were supposed to receive head and neck radiotherapy as part of their treatment.

Keywords: chamomile cryotherapy cryotherapy cancer children pediatric chemotherapy
comparison of gonioscopy with cirrus and visante

Conditions: Open Angle Glaucoma; Narrow Angles; Angle Closure Glaucoma

Summary: the aim of this study is to analyze similarities and evaluate interchangeability of visante and cirrus oct (optical coherent tomography)and to compare agreement between gonioscopy and the two systems for evaluation of anterior segment parameters.

all participants underwent routine ophthalmic examination by their physician. three independent examiners performed gonioscopy using spaeth gonioscopic grading system. findings were recorded independently along with risk assessment of angle being closed as: high, medium, and low or no risk. patient information was not available to doctor during gonioscopy. one eye of each patient was imaged using both visante and cirrus oct. imaging was performed under scotopic and photopic conditions and obtained from horizontal (3:00 and 9:00 o'clock) and vertical (6:00 and 12:00 o'clock) meridians. the same experienced independent examiner performed all cirrus measurements. visante was performed by 3 trained technicians using same protocol. oct images were exported and masked to be evaluated for presence of open or closed anterior chamber angle. masked images were presented with no other patient information available to two examiners with glaucoma training working together to score on basis of iridocorneal angle as, closed (0 degree), high possibility (10 degree), medium risk (20 degree), and low or no risk (\> 30 degree).

Eligibility criteria:
inclusion criteria: • 18 years of age and older with open angle, narrow angle and angle closure exclusion criteria: • all lasers or intraocular surgery (cataract, glaucoma, retina, cornea)

Keywords: open angle glaucoma narrow angles angle closure glaucoma gonioscopy anterior segment oct
analgesia in inguinal hernia repair using a cyclooxygenase-2-specific inhibitor

Conditions: Adverse Anesthesia Outcome

Summary: acute pain is the result of activating nociceptive pathways in both the peripheral and central nervous system. the origin of most acute pain from surgical stimulation is the mechanical trauma of the local tissue and the subsequent acute inflammatory response. no studies have investigated the combined use of anti-inflammatory analgesics with spinal anaesthesia/analgesia for pre, intra and postoperative multimodal pain protection in patients undergoing day-case ihr. the aim of the investigators study is therefore to assess the efficacy of preoperative combined administration of etoricoxib and standard spinal anaesthesia in the reduction of postoperative pain following ihr.

acute pain is the result of activating nociceptive pathways in both the peripheral and central nervous system. the origin of most acute pain from surgical stimulation is the mechanical trauma of the local tissue and the subsequent acute inflammatory response. open inguinal hernia repair is one of the commonest surgical procedures which may provoke pain of variable intensity and duration. etoricoxib (arcoxia®) is a nsaid with anti-inflammatory and analgesic properties mainly achieved via selective peripheral cox-2 inhibition. spinal anaesthesia using local anaesthetics combined with opioids affects the transmission, modulation and modification stages of nociceptive afferent impulses and its analgesic qualities are superior to local anaesthesia alone. no studies have investigated the combined use of anti-inflammatory analgesics with spinal anaesthesia/analgesia for pre, intra and postoperative multimodal pain protection in patients undergoing day-case ihr. the aim of the investigators study is therefore to assess the efficacy of preoperative combined administration of etoricoxib and standard spinal anaesthesia in the reduction of postoperative pain following ihr.

Eligibility criteria:
inclusion criteria: * american society anesthesiology class i and ii exclusion criteria: * under treatment with non steroid antinflammatory drug * under opioid treatment * peptic ulcer * liver insufficiency * renal insufficiency * asthma * cardiovascular disease

Keywords: etoricoxib spinal anaesthesia postoperative pain
efficacy study comparing hand-assisted laparoscopic and mini-incision muscle splitting incision living donor nephrectomy

Conditions: Living Donors

Summary: the purpose of this study is to compare the effects of hand-assisted laparoscopic and mini-incision muscle-splitting donornephrectomy on living kidney donors. the hypothesis is that the mini-incision is not inferior to the laparoscopic technique.

living kidney donation has become an important source for kidney transplantation because of insufficient numbers of post mortem kidney donations. to reduce the surgical trauma of the donor operation and improve postoperative recovery minimal invasive techniques have developed. especially the laparoscopic and the hand-assisted laparoscopic technique gained wide popularity. minimal invasive open techniques have had less publicity. one of those open techniques is to perform the open donornephrectomy by means of an anterolateral approach. a transverse subcostal incision of 10 cm or less is made. the abdominal wall is opened by splitting the muscles and sparing the nerves. staying in the retroperitoneal space the kidney is freed and taken out. laparoscopic approaches have especially become more popular after the hand-assisted technique had developed. by means of an 8 cm transverse suprapubic skin incision and a vertical midline fascia incision the abdominal cavity is opened and a hand is inserted in the abdomen through an air tight sleeve. three more trocarts are needed for the insufflation, the video camera and surgical instruments to perform a transperitoneal donornephrectomy. the hand in the abdomen assisting in the procedure has especially increased the sense of safety compared to the full laparoscopic technique without compromising the advantages of the laparoscopic technique. so far no prospective or retrospective study has been done comparing the hand-assisted laparoscopic with the mini-incision muscle-splitting technique. most studies that have been done comparing the (hand-assisted) laparoscopic technique with more invasive open techniques resulted in favour of the former technique. comparison(s): the study compares the effects of hand-assisted laparoscopic and mini-incision muscle-splitting donornephrectomy on living kidney donors.

Eligibility criteria:
inclusion criteria: * accepted as living kidney donor by local protocol * 18 years or older * excellent understanding of dutch language * able to be operated on by both surgical techniques * having read patient information and signed informed consent exclusion criteria: * previous surgery using subcostal incision(s) * not meeting the inclusion criteria

Keywords: living donors nephrectomy kidney transplantation randomized controlled trial laparoscopy
evaluation of surfactant protein b in the differential diagnostics of dyspnea

Conditions: Dyspnea; Cardiac Disease; Pulmonary Disease

Summary: establishing new biochemical markers in the differential diagnostics and risk stratification in heterogeneous patient collectives is becoming more and more important. the markers should be objective, reliable, reproducible, quick and cost effective as well as specific and sensitive. concerning the differential diagnostics of "dyspnea", nt-pro-bnp plays the most important role for the evaluation of a cardiac origin. however, a corresponding biochemical marker for pulmonary stress is lacking. the aim of the study at hand therefore was the evaluation of surfactant protein b in the differential diagnostics of pulmonary and cardiac diseases.


Eligibility criteria:
inclusion criteria: * patients presenting with dyspnea and giving informed consent exclusion criteria: * outpatients * lack or doubt of legal competence * indication for mechanical ventilation * pregnancy * palliative patients * cpap/ltot * bmi \> 30 kg/m2 * sepsis * anemia * dialysis

Keywords: surfactant protein b differential diagnostics
intraportal or intramuscular site for islets in simultaneous islet and kidney transplantation

Conditions: Type 1 Diabetes; End Stage Renal Disease

Summary: islet transplantation is a promising treatment of type 1 diabetes in selected cases. results are however hampered by a relatively low number of islets surviving the transplantation into the liver, which currently is the site for transplantation. in the present study we compare a new transplantation site (intramuscular in the arm) to the golden standard (the liver) in patients undergoing kidney transplantation from the same donor. in half of the intramuscular transplanted patients, the islets will be mixed with mesenchymal stemcells from the recipient to, possibly, improve the immunological aspects of the transplantation.


Eligibility criteria:
inclusion criteria: * male and female patients age 18 to 65 years of age. * ability to provide written informed consent. * mentally stable and able to comply with the procedures of the study protocol. * clinical history compatible with type 1 diabetes with onset of disease at \ 5 years at the time of enrolment. * absence of stimulated c-peptide \<0.1 nmol/l in response to a mmtt. * all subjects must have received adequate medical treatment of their diabetes under the guidance from an experienced diabetologist. * all subjects must have renal failure and be eligible for renal transplantation according to local criteria. exclusion criteria: * patients with prior organ transplants * patients that qualify for local simultaneous pancreas-kidney transplantation program and who prefer that option * patients with body mass index bmi \> 28. * insulin requirement \> 1 unit/kg/day. if the patient is on peritoneal dialysis the same limit is set when the extra carbohydrates in the dialysis fluids have been accounted for. * consistently abnormal liver function tests ( \> 1.5 x the upper limit of normal on two consecutive measurements \> 2 weeks apart) * unstable diabetic retinopathy * hypercoagulability disorder or coagulopathy or international normalized ratio (inr)\>1.5 * any history of malignancy except for completely resected squamous or basal cell carcinoma of the skin * patients with unstable cardiovascular status * patients with active infections, unless treatment is not judged necessary by the investigators * patients with serological evidence of infection with hiv, hepatitis b (patients with serology consistent with previous vaccination and a history of vaccination are acceptable) or hepatitis c.

Keywords: type 1 diabetes islets transplantation nephropathy intramuscular
safety and effectiveness of nitazoxanide for the treatment of cryptosporidiosis in aids patients

Conditions: Cryptosporidiosis; HIV Infections

Summary: the purpose of this study is to see if it is safe and effective to treat cryptosporidiosis in aids patients with nitazoxanide.

patients take nitazoxanide daily for 8 weeks with a dose escalation after the first 4 weeks. patients return to the hospital for examinations every 2 weeks during the 8-week treatment period and 6-week follow-up. nitazoxanide therapy is discontinued in patients showing a complete clinical and parasitologic response (therapeutic cure) after 8 weeks of treatment and in patients showing a therapeutic cure at two consecutive visits (weeks 2 and 4 or weeks 4 and 6). these patients undergo a physical examination including stool analysis for cryptosporidium parvum oocysts and routine laboratory tests at weeks 2, 4, and 6 after completion of nitazoxanide therapy. patients who do not show a complete clinical and parasitologic response (therapeutic failure) after 8 weeks of treatment are allowed to remain on nitazoxanide therapy through the open label compassionate use of nitazoxanide in treatment of cryptosporidiosis in aids patients (umd-95-009) protocol.

Eligibility criteria:
inclusion criteria patients may be eligible for this study if they: * are hiv-positive. * have a cd4 cell count of 50 cells/mm3 or less. * have evidence of cryptosporidium infection in their stool sample within 10 days of study entry. * have watery stools at least three times a day at least 5 days a week for 21 days prior to enrollment. * are able to take medications by mouth. * are at least 13 years old (consent of parent or guardian required if under 18). * agree to use an effective method of birth control (such as condoms) during the study. exclusion criteria patients will not be eligible if they: * have certain diseases or infections of the intestines. * have ever taken nitazoxanide. * have taken certain experimental drugs within 14 days of enrollment. * will need to take certain other medications during the study such as paromomycin, azithromycin, and clarithromycin. * have started a new anti-hiv therapy within 4 weeks of study entry or plan on starting one during the study. * are pregnant or breast-feeding.

Keywords: aids-related opportunistic infections cryptosporidiosis drug evaluation antiprotozoal agents treatment failure nitazoxanide