Kornimate/medical-research-clean huggingface dataset:
an extension study to evaluate the long-term efficacy and safety of oxabact in patients with primary hyperoxaluria

Conditions: Hyperoxaluria, Primary

Summary: open label extension study of oxabact oc5 in patients with primary hyperoxaluria

oc5-ol-02 (ephex-ole) is a 2 year, open-label, extension study to evaluate the long-term efficacy and safety of oxabact oc5 for patients with primary hyperoxaluria who completed treatment in the parent double-blind, placebo-controlled study oc5-db-02 (ephex).

Eligibility criteria:
inclusion criteria: 1. signed informed consent (as applicable for the age of the subject). 2. participation in and completion of study oc5-db-02. 3. subjects who had received vitamin b6 during oc5-db-02 study should maintain a stable dose. subjects not receiving vitamin b6 during oc5-db-02 must be willing to refrain from initiating pyridoxine during study participation. exclusion criteria: 1. inability to swallow size 4 capsules. 2. use of antibiotics to which o. formigenes is sensitive. 3. current treatment with a separate ascorbic acid preparation. 4. pregnant or lactating women (or women who are planning to become pregnant). 5. women of childbearing potential who are not using adequate contraceptive precautions. 6. presence of a medical condition that the investigator considers likely to make the subject susceptible to adverse effect of study treatment or unable to follow study procedures or any condition that is likely to interfere with the study drug mechanism of action (such as abnormal gi function). 7. participation in any interventional study of another investigational product, biologic, device, or other agent or not willing to forego other forms of investigational treatment during this study.
paclitaxel coated balloon catheter for prevention of restenosis in femoropopliteal arteries

Conditions: Peripheral Arterial Disease

Summary: the paccocath fem study is a randomized, double-blinded german multicenter trial on the efficacy and tolerance of a paclitaxel coated balloon catheter in prevention of restenosis after femoropopliteal angioplasty.

background: treatment of patients with peripheral arterial disease (pad) in the femoropopliteal arteries by percutaneous intervention is still limited by high rates of restenosis. the aim of the present study is to evaluate the efficacy and safety of a novel method of short time local drug delivery based on a paclitaxel-coated balloon in femoropopliteal arteries. methods and results: the double-blind and randomized study enrolled n=79 patients with occlusion or stenosis of femoropopliteal arteries. inclusion criteria were clinical rutherford stage 1-5, occlusion or hemodynamic relevant stenosis (≥ 70 % diameter) of femoropopliteal arteries and successful guiding wire recanalization. the primary endpoint was the late lumen loss after 6 months follow-up as seen in angiography. secondary endpoints included the rate of restenosis (a binary variable), change of ankle brachial index (abi), rutherford class and major adverse events.

Eligibility criteria:
inclusion criteria: * rutherford stage 1, 2, 3, 4 oder 5 * occlusion or stenosis of superficial femoral and/or popliteal artery * successful guide wire passage of the lesion * patient suitable of vascular surgery in case of complication * written consent * patient is willing to take part in follow up examinations within the study exclusion criteria: * acute ischemia * distal run off less than one vessel * pregnancy * hyperthyroidism * thrombocytes \ 700.000/mm3, leucocytes \<3.000/mm3 * life expectancy less than two years * patients not willing to enter the study

Keywords: restenosis peripheral arterial disease paccocath drug-coated balloon
child-parent psychotherapy for preschooler witnesses of domestic violence program

Conditions: Domestic Violence Exposure

Summary: this study will examine the efficacy of child-parent psychotherapy (cpp) for the treatment of preschoolers exposed to marital violence.

this study examines the efficacy of child-parent psychotherapy (cpp) for the treatment of preschoolers exposed to marital violence. multi-ethnic preschool-mother dyads from diverse socioeconomic backgrounds were randomly assigned to cpp or to a case management plus community referral for individual treatment comparison group. it was hypothesized the children who received cpp treatment would show significantly greater improvement in general symptomatology and in traumatic stress symptoms than those in the comparison group. there is growing recognition that, contrary to the long-standing assumption that young children are impervious to environmental stresses, preschoolers exposed to violence show increased rates of disturbances in self-regulation and in emotional, social and cognitive functioning (osofsky, 2004; pynoos et al., 1999; van der kolk, 2003). the present study examines the efficacy of a relationship-based treatment approach involving the child and the mother. dyads were randomly assigned to either the child-parent psychotherapy (cpp) treatment group or to a comparison group that consisted of monthly case management by an experienced ph.d.-level clinician plus referrals for individual treatment in the community for mothers and child. we hypothesized that child-parent psychotherapy would be more effective in alleviating children's traumatic stress symptoms and behavior problems because it focuses on improving the quality of the child-mother relationship and engages the mother as the child's ally in coping with the trauma. treatment was offered for 50 weeks.

Eligibility criteria:
inclusion criteria: * child 3-5 years old * child exposed to marital violence as confirmed by mother's report on the conflict tactics scale 2 (straus et al., 1996) * perpetrator was not living in the home. exclusion criteria: * mother's documented abuse of the target child * current maternal substance abuse * homelessness * maternal mental retardation * maternal psychosis * child mental retardation or autistic-spectrum disorder

Keywords: domestic violence preschoolers trauma intervention
effect of abdominal massage on bowel evacuation after cranial surgery

Conditions: Constipation; Abdominal Massage

Summary: many factors in patients undergoing cranial surgery (cs) may affect the bowel evacuation of patients, resulting in constipation, which could lead to the use of the valsalva maneuver. the aim of this study was to determine the effect of abdominal massage (am) on bowel evacuation of patients treated in intensive care units (icu) after cs.

the sample of this prospective parallel two-arm randomized controlled trial included 80 patients who underwent cs. the patients were randomly assigned (1:1) to the am and control groups. the constipation risk of all the patients following cs was assessed with constipation risk assessment scale (cras). those patients in the am group received a total of 30 minutes of massage, 15 minutes every morning and evening, until the first defecation. the bowel sounds of all the patients in the am and control groups were assessed on a daily basis. the days when bowel sounds were heard and the first defecation took place were recorded in a bowel evacuation form.

Eligibility criteria:
inclusion criteria: patients who * volunteered to participate in the study, * were 18 years old or older and underwent cs, * stayed in the icu for ≥ 3 days, exclusion criteria: patients who * have percutaneous endoscopic gastrostomy, * abdominal hernia, * irritable bowel syndrome * bowel cancer, * history of abdominal surgery, * pregnancy,

Keywords: cranial surgery bowel evacuation constipation abdominal massage nursing
methylene blue as a third-line vasopressor in septic shock

Conditions: Septic Shock

Summary: a randomized, prospective study comparing provayblue® to standard care with multiple sympathomimetic vasopressors.

the study will be an un-blinded, phase 2, randomized, 1:1, prospective trial comparing patients in septic shock receiving norepinephrine and vasopressin followed by phenylephrine versus provayblue® as the third-line vasopressor. the third line vasopressor will be compared at 1 hour to see if it affects the patient's mean arterial blood pressure (map).

Eligibility criteria:
inclusion criteria: 1. meets sepsis-3 criteria (suspected source of infection plus any 2 criteria of the qsofa) 2 .septic shock (any patient requiring vasopressor therapy to maintain map \>65 mmhg or any patient with serum lactate \>2 mmol/dl even in the absence of hypovolemia ). 3) greater than 18 years old 4 ) icu admission exclusion criteria: inability to obtain informed consent from an appropriate surrogate decision maker. also: 1. children less than 18 years old 2. pregnant women or positive urinary pregnancy test in reproductive-aged women 3. prisoners 4. evolving myocardial infarction or known cardiomyopathy with documented ef\<35% 5. known grade 3 diastolic dysfunction document by echocardiogram 6. known hypersensitivity to thiazine dyes 7. pulmonary hypertension that is currently requiring vasodilator therapy 8. concurrent form of shock present or suspected: obstructive, neurogenic, hemorrhagic 9. known documented history of g6pd deficiency or favism 10. active prior to admission medication prescription for a ssri or snri , systemic heparin anticoagulation or other medications listed above (under study agent). these medications will be listed in the printed enrollment form. 11. severe renal failure is a contraindication to use of provayblue®.

Keywords: methylene blue vasopressors septic shock provay blue®
efficient study of acular in inhibiting proliferative retinopathy in prematurity

Conditions: Retinopathy of Prematurity; Retinal Detachment; Blindness

Summary: the purpose of this study is to test whether acular, a nonsteroidal anti-inflammatory eye drop medication, can prevent the development of retinopathy of prematurity (rop) and/ or decrease its severity.in this study acular will be compared to a placebo (artificial tear). the hypothesis would be that acular treatment will decrease the incidence of moderate to severe rop (grade ii and above)by 50%.

each year rop affects an estimated 14,000-16,000 premature, low birth weight infants in the united states and thousands more worldwide, making it a leading cause of vision loss in children. of these cases, approximately 1500 infants will develop severe rop that requires surgical treatment. despite those treatment, about 400-600 infants with severe rop still become legally blind each year. acular® (ketorolac eye drop) is a member of nonsteroidal anti-inflammatory drugs (nsaids) available for toipcal ocular use. acular acts as prostaglandin inhibitor and as such decrease prostaglandin e2 production. an increase in prostaglandin production has been associated with various inflammatory eye disease.for instance acular has been shown to be effective in preventing the post cataract surgery inflammation that result in macular edema in adults. activation of the prostaglandin cascade has been demonstrated in animal models of rop. a previous non randomized study using acular for rop prevention has shown a possible beneficial effect and no observed adverse effect. to clearly demonstrated and confirm this finding a randomized study is thus necessary before one can advocate its use for prevention of rop.the medication is fda approved in pediatrics for allergic conjunctivitis and post surgical ocular inflammation.

Eligibility criteria:
inclusion criteria: * all preterm infants of gestational age less or equal to 28 weeks completed gestational age and 10 to 15 days of postnatal age admitted to our regional nicu

Keywords: retinopathy of prematurity premature infants acular refresh tears
evaluation of sperm selection technique using hyaluronic acid binding in intra-cytoplasmic sperm injection (icsi)

Conditions: Infertility, Male

Summary: in vitro sperm selection for icsi is important as it has a direct influence on the paternal contribution of preimplantation embryogenesis. various laboratory tests were developed to assess the functions of the spermatozoa. among them, only the tests for sperm dna fragmentation, hyperactivation of the spermatozoa and the hyaluronan-binding ability are simple and fast.

in vitro sperm selection for icsi is important as it has a direct influence on the paternal contribution of preimplantation embryogenesis. men with oligozoospermia who require icsi often demonstrate compromised dna integrity and increased chromosomal aberrations of the sperms in their semen. studies have shown that embryos resulting from icsi in those men have higher risk of sex chromosome disomies, chromosomal aneuploidies, de novo numerical chromosomal aberrations and cytogenetically detectable structural chromosomal aberrations. although the main candidates for icsi are oligozoospermic men, there is an increase in the use of icsi, therefore, more couples are potentially exposed to those potential risks. various laboratory tests were developed to assess the functions of the spermatozoa. among them, only the tests for sperm dna fragmentation (halosperm), hyperactivation of the spermatozoa and the hyaluronan-binding ability (hba) are simple and fast enough to allow the same semen sample tested to be used for oocytes' insemination. spermatozoa that are fail to bind to hyaluronan have many aspects of immaturity. they retain histones in the sperm nucleus, cytoplasm on the sperm neck, and have higher aberrant sperm head morphology, in addition to, lower genomic integrity. it has also been shown that sperm dna fragmentation is associated with male factor of infertility, correlating with the morphology and motility of spermatozoa. the aim of the present study is to carry out a comparative analysis between two groups: hyaluronan binding system for sperm selection for icsi procedures and another group of conventional morphology sperm selection (icsi-pvp), both in cycles with only male infertility factor. the evaluated parameters were semen quality, fertilization and cleavage rates, chemical and clinical pregnancy, and miscarriage rates.

Eligibility criteria:
inclusion criteria: * female 20-40 years * male factor infertility exclusion criteria: * other factor of infertility (tubal, uterine, ... etc)
safety and efficacy of dose conversion from vicodin® to buprenorphine transdermal system (butrans™) in subjects with oa pain

Conditions: Osteoarthritis

Summary: the objective of this study is to evaluate the safety and efficacy of dose conversion from hydrocodone/ acetaminophen (vicodin®) to the buprenorphine transdermal system (butrans™) in subjects with osteoarthritis pain of the hip or knee. the double-blind treatment intervention duration is 2 weeks during which time supplemental analgesic medication will be allowed.

buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain.

Eligibility criteria:
inclusion criteria: - osteoarthritis of the hip or knee taking a regularly scheduled regimen of hydrocodone/ acetaminophen for their osteoarthritis oa pain. exclusion criteria: * currently have condition requiring a stable regimen of acetaminophen (apap). * a history of chronic conditions, other than oa of the hip or knee joints, requiring frequent, intermittent analgesic therapy. other protocol-specific exclusion/inclusion criteria may apply.

Keywords: osteoarthritis, opioid, transdermal
persistence, adherence, quality of life, and treatment satisfaction with avonex® pen™.

Conditions: Multiple Sclerosis

Summary: the primary objective of the study is to determine physician reported persistence with the avonex pen at month 12/end of study as well as determining factors associated with persistence. the secondary objectives for this study are as follows: to evaluate the tolerability for treatment administration of the avonex pen at months 3, 6, and 12; to evaluate patient quality of life (qol) while using the avonex pen for treatment administration at months 3, 6, and 12; to evaluate clarity of directions for use of the avonex pen at month 3; to evaluate ease of use and the patient's assessment of the injection procedure with the avonex pen at months 3, 6, and 12; to evaluate patient reported adherence at months 6 and 12; to evaluate physician reported persistence at month 6; to evaluate overall patient satisfaction with the use of the avonex pen for treatment administration at months 3, 6, and 12; to evaluate patient reported fear of injection at months 3, 6, and 12; and to evaluate the percentage of patients switching from caregiver to self-injection at months 3, 6, and 12.


Eligibility criteria:
inclusion criteria: * ability to understand the purpose and risks of the study and provide signed and dated informed consent * must satisfy the locally approved therapeutic indications for the avonex pen * decision to treat with avonex pen must precede enrollment * must have no more than two (2) injections with the avonex pen prior to enrollment exclusion criteria: * inability to comply with study requirements * other unspecified reasons that, in the opinion of the investigator or biogen idec, make the patient unsuitable for enrollment
phase 1 first-in-human study of js014

Conditions: Neoplasm Malignant; Neoplasm, Experimental; Solid Tumor, Adult; Lymphoma

Summary: this phase 1, first-in-human study uses a boin design to assess the safety and potential efficacy of js014 at different dose levels as a single agent and in combination with fixed dose of pembrolizumab in subjects with advanced cancer.

this study has two parts: 1a and ib. ia is a single agent study, and ib is a combination study, testing the safety of js014 with 200 mg of pembrolizumab. after being informed about the study and the potential risks, all subjects giving written informed consent will receive at most 4-week screening procedures to ensure the eligibility of the study entry. once eligible, the subjects will receive js014 infusion at the designated dose levels once every week until disease progression. in ia study, only js014 is given. in ib study, js014 will be given once a week with pembrolizumab at 200 mg once every three weeks until disease progression. the subjects will receive safety evaluation, pharmacokinetic and pharmacodynamic studies, as well as efficacy evaluation at regular interval. the maximum number in each part of the study is 30 subjects. the ia study will be conducted in taiwan, and ib study will be conducted in both taiwan and the united states.

Eligibility criteria:
inclusion criteria: * older 18 years of age or per local regulation * subjects with advanced cancer or lymphoma who have no standard therapy available, ineligible for standard therapy or unwilling to receive cytotoxic therapy . * ecog ps 0-1 * a life expectancy longer than three months * adequate organ functions * able to adopt effective contraceptive measures exclusion criteria: * known history of allergies to js014 or il-21 or human serum albumin or pembrolizumab (ib only) * subjects who have received major surgery less than 4 weeks before 1st infusion of js014 * subjects who has a history of immune-related adverse events in prior immunotherapy. * subjects who have received immunosuppressive therapy less than 4 weeks before 1st infusion of js014. * subjects who have two or more primary cancers in the past 5 years. * newly diagnosed or symptomatic brain metastases. * subjects who have received prior anti-cancer therapy with residual toxicities greater than grade 2. * subjects who have a history of autoimmune disease in 2 years. * subjects who have active infection, or uncontrollable hypertension, unstable angina, active peptic ulcer, recent acute myocardial infarction, severe congestive heart failure, or unhealed wound. * subjects with active hepatitis b or hepatitis c. * subjects who are pregnant or breast feeding. * subjects who primary immune deficiency.

Keywords: phase 1 js014 first-in-human
a t drain approach treating anastomotic leaks after gastrointestinal surgery

Conditions: Colorectal Cancer; Diverticulitis

Summary: assessing the use of a t drain approach for an anastomotic leak after gastrointestinal surgery. the study's aim is to retrospectively assess the safety and benefits of this approach.

assessing the use of a t drain approach for an anastomotic leak after gastrointestinal surgery. the t drain approach is inserting a latex t tube drain into the leak site of the anastomosed bowel and diverting the fecal matter. the study's aim is to retrospectively assess the safety and benefits of this approach.

Eligibility criteria:
inclusion criteria: * patients after elective or emergent gastrointestinal surgery with a leak in their gi anastomosis exclusion criteria: * under 18 years of age * pregnancy
effectiveness of tuberosity micro connective tissue graft for treatment of multiple adjacent gingival recession defects

Conditions: Gingival Recession, Localized

Summary: the objective of this project is to compare post-operative pain associated with palatal and tuberosity donor sites for micro-ctg, and to evaluate the outcomes in both the donor and recipient sites.

a variety of surgical methods have been reported to reestablish root coverage, including tunneling techniques and coronally and laterally advanced flaps. as thin gingival tissue is one of the predisposing factors for grd, the adjuvant use of subepithelial connective tissue grafts (ctgs) is often considered. ctgs are thought to contribute to phenotype modification and stability of treatment outcomes and studies have indicated favorable esthetic results and high degrees of root coverage. ctgs are preferably harvested either from the lateral superficial part of the palate or from the tuberosity, due to the high amount of lamina propria and minimal submucosal tissue (adipose and glandular tissue). when multiple adjacent teeth exhibit grds, the preferred surgical approach should offer the greatest possible root coverage, while limiting drawbacks (i.e., patient morbidity, esthetic problems). thus, one of the challenges related to coverage of multiple grds is the scarcity of donor tissue. modification of the harvested ctg into multiple "micro-ctg" has been proposed for the treatment of multiple adjacent grds (magrd) in order to reduce the amount of ctg to be harvested. soft-tissue grafts from the tuberosity are increasingly gaining popularity not only because they are easier to harvest, are denser in connective tissue fibers but also because harvesting from the tuberosity presents minimal risk of intra- or post-operative complications, resulting in reduced patient morbidity. however ctg from maxillary tuberosity have been reported to induce a hyperplastic response in some patients. the objective of this study will be to compare palatal versus tuberosity micro-ctg on postoperative pain, oral health-related quality of life (ohrqol), degree of root coverage and esthetic outcomes. the investigators hypothesise that no statistically significant differences will be observed in terms of %root coverage and patient satisfaction at 12 months (non-inferiority). subjects in the test group (micro-ctg) will report significantly lower morbidity at 1 and 2 weeks post-surgery when compared to controls (superiority).

Eligibility criteria:
inclusion criteria: * age ≥18 years, * systemically healthy, * presenting adjacent rt1/rt2 recessions, on both sides of the anterior maxilla, with an apico-coronal extension (i.e. recession depth) \> 2mm combined with thick phenotype and deep root concavity. exclusion criteria: * pregnancy or lactation, * heavy tobacco smoking (\>15 cigarettes/day), * uncontrolled medical conditions and intake of medication that can affect gingival conditions. * uncorrected trauma from toothbrushing, * severe tooth malposition, * history of root coverage procedures.