Kornimate/medical-research-clean huggingface dataset:
safety, efficacy, and tolerability of bos172738 in patients with advanced rearranged during transfection (ret) gene-altered tumors

Conditions: Advanced Nonhaematologic Malignancies

Summary: this study will be conducted to assess the safety and tolerability of bos172738 when administered to patients with advanced solid tumors with rearranged during transfection (ret) gene alterations and also to establish the maximum tolerated dose (mtd) and/or recommended phase 2 dose (rp2d) of bos172738.


Eligibility criteria:
inclusion criteria: participants are eligible to be included in the study only if all of the following criteria apply: * male or female participants must be ≥ 18 years, at the time of signing the informed consent * diagnosis of advanced solid tumor with a documented rearranged during transfection (ret) gene altered malignancy as determined locally by a dna based assay of tumor tissue and/or blood * participants must have no alternative approved therapy. * for participants in part b expansion cohort only: documented local diagnosis of either 1) advanced ret gene fusion non-small cell lung cancer (nsclc); 2) advanced ret gene mutant medullary thyroid cancer (mtc); or 3) other ret gene altered advanced tumors or nsclc/mtc with prior specific ret gene targeted therapy * eastern cooperative oncology group (ecog) performance status of 0 or 1 * negative pregnancy test for females of child bearing potential; must be surgically sterile, postmenopausal, or willing and able to be compliant with a contraceptive regimen * contraceptive use by men or women should be consistent with local regulations. * capable of giving signed informed consent exclusion criteria: participants are excluded from the study if any of the following criteria apply: * inability to take oral medications or gastrointestinal (gi) conditions that can interfere with the swallowing or absorption of study medication * uncontrolled or severe concurrent medical condition * history of upper gi bleeding, ulceration, or perforation within 12 months prior to the first dose of study drug * known history of stroke or cerebrovascular accident within 6 months prior to the first dose of study drug * participants with known infection with human immunodeficiency virus (hiv) or acquired immune deficiency syndrome (aids) (testing not required) * participants who are hepatitis b surface antigen positive or participants who are hepatitis c antibody positive (participants who have been successfully treated for hepatitis c virus \[hcv\] are eligible if an undetectable hcv viral load at least 6 months after completion of treatment can be demonstrated.) * any evidence of serious active infections * uncontrolled or severe cardiovascular disease * uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements * participants with a prior or concurrent malignancy other than the malignancies under study * ongoing cancer directed therapy

Keywords: bos172738 ret gene medullary thyroid cancer non-small cell lung cancer
a study to test the efficacy and safety of certolizumab pegol in japanese subjects with moderate to severe chronic psoriasis

Conditions: Moderate to Severe Psoriasis; Generalized Pustular Psoriasis and Erythrodermic Psoriasis

Summary: the purpose of this study is to demonstrate the efficacy and safety of certolizumab pegol (czp) in the treatment of moderate to severe chronic plaque psoriasis (pso) in japanese subjects.


Eligibility criteria:
inclusion criteria: * subject is male or female, \>= 20 years of age. * institutional review board-approved written informed consent form is signed and dated by the subject. * other protocol-defined inclusion criteria may apply. for subjects with moderate to severe chronic plaque psoriasis (pso) * chronic plaque psoriasis for at least 6 months. * baseline psoriasis activity and severity index (pasi) \>=12 and body surface area (bsa) affected by pso \>=10% and physician's global assessment (pga) score of 3 or higher. * candidates for systemic pso therapy and/or phototherapy and/or chemophototherapy. for subjects with generalized pustular pso or erythrodermic pso * diagnosis of generalized pustular pso or erythrodermic pso at screening. * history of plaque-type pso if subjects have a diagnosis of erythrodermic pso. * baseline bsa affected by pso \>=80% if subjects have a diagnosis of erythrodermic pso. exclusion criteria: * female subject who is breastfeeding, pregnant, or plans to become pregnant during the study or within 5 months following last dose of study drug. male subject who is planning a partner pregnancy during the study or within 5 months following the last dose of study drug. * subject has guttate psoriasis or drug-induced psoriasis. for subjects with moderate to severe plaque psoriasis, erythrodermic or pustular forms of psoriasis also are excluded. * history of current, chronic, or recurrent infections of viral, bacterial, or fungal origin as described in the protocol. also, subjects with a high risk of infection in the investigator's opinion. * history of a lymphoproliferative disorder including lymphoma or current signs and symptoms suggestive of lymphoproliferative disease. * history of other malignancy or concurrent malignancy as described in the protocol. * class iii or iv congestive heart failure * history of, or suspected, demyelinating disease of the central nervous system (e.g., multiple sclerosis or optic neuritis). * subject has any other condition which, in the investigator's judgment, would make the subject unsuitable for inclusion in the study. * concurrent medication restrictions as described in the protocol. * subject with known tuberculosis (tb) infection, at high risk of acquiring tb infection, or with untreated latent tuberculosis infection (ltbi) or current or history of nontuberculous mycobacterial (ntmb) infection. * subject has any protocol defined clinically significant laboratory abnormalities at the screening * other protocol-defined exclusion criteria may apply.

Keywords: psoriasis pso chronic plaque psoriasis certolizumb pegol cimzia generalized pustular psoriasis and erythrodermic psoriasis
effect of preoperative abdominal exercises and russian current on muscle strength post ventral hernioplasty

Conditions: Muscle Strength

Summary: the study was conducted to investigate the effect of preoperative graduated abdominal strengthening exercises and russian stimulation on the abdominal muscles strength after ventral hernioplasty by using isokinetic dynamometer and ultrasonography as methods of measurement.

the study was conducted to investigate the effect of preoperative graduated abdominal strengthening exercises and russian stimulation on the abdominal muscles strength after ventral hernioplasty by using isokinetic dynamometer and ultrasonography as methods of measurement.

Eligibility criteria:
criteria of inclusion: * the age is from 20 to 45 years. * all patients want to optionally repair surgery. * ventral hernia is diagnosed on the basis of a surgeon evaluation. * the study will include all patients. * the informed consent of all the patients enrolled. criteria for exclusion: * history of surgical interference for less than one year (abdominal surgery). * cirrhosis of the liver with ascites or without them. * deformity or contracture of the hip or spine. * obstruction of bowel, peritonitis or drilling.

Keywords: ventral hernia graduated abdominal exercises isokinetic dynamometer.
efficacy trial of two pneumococcal conjugate vaccines (pnccrm and pncompc) for prevention of acute otitis media due to vaccine serotypes

Conditions: Otitis Media; Pneumococcal Infections

Summary: this was a randomized, double-blinded multicenter cohort study of finnish children aged 2 to 24 months. the study was designed to evaluate the efficacy of two 7-valent pneumococcal conjugate vaccines (pnccrm and pncompc) parallelly, both vaccines compared with the same control vaccine (hepatitis b vaccine). the primary endpoint was culture-confirmed pneumococcal acute otitis media (aom) episodes due to all serotypes included in the pneumococcal conjugate vaccine and the primary hypothesis was that, compared to the control vaccine group, the pneumococcal conjugate vaccine would protect infants from culture confirmed aom caused by pneumococcal serotypes in the vaccine. the efficacy of the two vaccines against any pneumococcal aom and any aom was also evaluated. the children were vaccinated with the pneumococcal conjugate vaccine or the control vaccine at the age of 2, 4, 6 and 12 months and followed at study clinics established specifically for the purpose from 2 to 24 months of age. whenever aom was diagnosed during the follow-up, middle ear fluid was aspirated for bacterial culture.


Eligibility criteria:
inclusion criteria: * infants coming to their own child health center before the age of 13 weeks, and judged to be in good health on the basis of medical history and physical examination * family living permanently in tampere, kangasala or nokia * at least one of the parents/guardians is able to communicate fluently in finnish * written informed consent obtained from a parent/guardian prior to enrollment in the study exclusion criteria: * hypersensitivity to any of the components of the vaccines used in the study, * known or suspected impairment of immunologic function, * history of invasive pneumococcal disease, * prior vaccination with any pneumococcal vaccine, * prior vaccination with hepatitis b vaccine, * contraindications to routine childhood immunizations * any medical condition in which, in the opinion of the investigator, the study procedures or vaccinations might cause risk to the health or endanger the well-being of the child

Keywords: otitis media pneumococcal infections pneumococcal vaccines proportional hazards models prospective studies streptococcus pneumoniae vaccines, conjugate
effects of a transitional palliative care model on patients with end-stage renal failure

Conditions: Palliative Care; Renal Failure, End-stage

Summary: primary aim: 1. to compare the effects of customary care and an interventional home-based palliative renal program (hbprp) for esrf patients 2. to compare the effects of customary care and home-based palliative program (hbpp) for esrf patients secondary aim: 3. to explore the lived experiences of patients with esrf. hypothesis the transitional renal palliative care model is associated with decreased in unscheduled hospital readmission, reduce length of stay as well as improved quality of life for patients with end-stage renal failure.

objectives related to the primary aim: 1. are there differences in healthcare utilization between the esrf patients in the customary care group and those in the hbprp group; in the hbprp group and hbpp group? 2. are there differences in evaluated health outcomes (functional status, symptom intensity, and satisfaction with care) between the customary care group and the hbprp group ; in the hbprp group and hbpp group? 3. are there differences in perceived health outcomes (quality of life, caregiver burden) between the customary care group and the hbprp group; in the hbprp group and hbpp group? related to the secondary aim: 4. how are the lived experiences compared and contrasted between the customary care group and the hbprp group; in the hbprp group and hbpp group?

Eligibility criteria:
inclusion criteria: * patient with chronic kidney disease and diabetic mellitus with creatinine ≥350 milli mole (um) or those without diabetic mellitus with creatinine ≥450 milli mole (um) who refused renal replacement therapy (rrt); * patient not suitable for long term renal replacement therapy (rrt) after assessment by renal team (e.g. multiple co morbidities, poor functional status and social support) * identified as esrf patient eligible for palliative care without prior renal replacement therapy * ability to speak cantonese * living within the hospital service area * ability to be contacted by phone exclusion criteria: * discharged to nursing home or other institution * inability to communicate * cognitive impairment, mini mental stage examination (mmse) \< 20 * diagnosed with severe psychiatric disorders such as schizophrenia and bipolar disorder

Keywords: transitional palliative care end stage renal failure
smartwatch-supported internet-delivered intervention for depression

Conditions: Depression

Summary: the current study seeks to investigate the acceptance of the use of a smartwatch in an internet-delivered cognitive behavioural therapy (cbt) based intervention for depression.

eligible patients (n=70) will be invited to use the supported intervention over an 8-week period. participants who have indicated consent will be randomised in two arms: icbt intervention - treatment as usual (n=35) and icbt intervention with smartwatch (n=35). participants in the smartwatch group will be lent a smartwatch for the duration of treatment, with an app allowing them to monitor their mood in the moment, and keep track of their daily sleep and activity level. all participants will be asked to complete an acceptance questionnaire regarding the technology at three time points: before first use, at 3 weeks, and 8 weeks. this study will contribute to the growing literature on acceptance of technology supporting mental health interventions worldwide. the results may help to establish criteria for patient acceptance of the smartwatch technology as a treatment enhancer in the context of mental health interventions.

Eligibility criteria:
inclusion criteria: * eligible for the internet-delivered cbt intervention 'space from depression' * own a compatible mobile device (iphone 6 or upper) exclusion criteria: * suicidal intent/ideation; score \>2 on phq-9 question 9 * psychotic illness * alcohol or drug misuse * previous diagnosis of an organic mental health disorder * currently in psychological treatment for depression symptoms * unstable medication regimens

Keywords: patient acceptance internet-delivered treatment depression self-monitoring smartwatch wearable
neoadjuvant immunotherapy with chemotherapy for stage i-iiib non-small cell lung cancer patients

Conditions: Non-small Cell Lung Cancer

Summary: a phase ii, single-arm, open-label study that assesses feasibility, safety and efficacy of combined neoadjuvant chemotherapy and immunotherapy with pd-(l)1 inhibitor in stage i-iiib nsclc adult patients followed by adjuvant pd-(l)1 inhibitor treatment for up to 1 year

a phase ii, single-arm, open-label study that assesses feasibility, safety and efficacy of combined neoadjuvant chemotherapy and immunotherapy with pd-1 inhibitor in stage i-iiib nsclc adult patients followed by adjuvant treatment for up to 1 year with pd-(l)1 inhibitor. two to three cycles of neoadjuvant chemotherapy in combination with pd-(l)1 inhibitor will be administered before surgery, followed by another one to two cycles of neoadjuvant chemotherapy in combination with pd-(l)1 inhibitor and pd-(l)1 inhibitor monotherapy for up to 1 year. after completion of neoadjuvant therapy and before surgery, a tumor assessment will be done. patients with stable disease or partial response may be considered for surgery. the report imaging response and pathological response rate will be evaluated. patients eligible for the trial are those with a histological diagnosis or cytologically proven operable and resectable non-small-cell lung cancer. the total number of patients to be included will be 60 from chinese academy of medical sciences (cams). accrual period of 2 years or until the inclusion of the last patient necessary to achieve the sample set in the protocol of 60 patients. after that all patients will be treated for up to 1 year with adjuvant immunotherapy and they will be followed during 3 years after adjuvant treatment.

Eligibility criteria:
inclusion criteria: - 1.histologically- or cytologically- documented nsclc who present stage i (t≥4cm), iia, iib, iiia, or iiib disease, of either squamous or non-squamous histology. 2.deemed surgically resectable by a thoracic surgeon 3.age ≥ 18 years 4.radiologically measurable disease, as defined by response evaluation criteria in solid tumours (recist) v1.1 5. eastern cooperative oncology group (ecog) performance status of 0 or 1 6.notified of the investigational nature of this study and signed a written informed consent in accordance with institutional and national guidelines. exclusion criteria: * 1. carrying activating mutations in the tk domain of egfr or any variety of alterations in the alk gene or other mutations predicting hyperprogression of immunotherapy. 2. active, known or suspected autoimmune disease. 3.other active malignancy requiring concurrent intervention or with previous malignancies (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colon, endometrial, cervical/dysplasia, melanoma, or breast). 4.prior treatment with anti-pd-1, anti-ctla-4 (cytotoxic t lymphocyte-associated antigen (ctla-4), or anti-pd-l1 therapeutic antibody or pathway-targeting agents 5.history of allergy to study drug components excipients
evaluation of the effects of hypoglossal nerve stimulation in humans with obstructive sleep apnea

Conditions: Sleep Apnea; Sleep Apnea, Obstructive; Sleep Disorder; Sleep Apnea Syndromes

Summary: this proof-of-concept study is being performed to evaluate whether the hypoglossal nerve can be stimulated using a small series of electrodes placed surgically via a percutaneous approach. minimally invasive off the shelf medical devices will be used and observation of the characteristic physiological responses to stimulation of the hgn, will be assessed.


Eligibility criteria:
inclusion criteria: subject must be eligible for a diagnostic or surgical procedure and * suffers from osa (apnea/hypopnea index \>10 event/h sleep) based on history and a physical exam. * is a surgical candidate. * is willing and capable of providing informed consent. * is willing to have a representative electrode array temporarily placed in the submandibular and mylohyoid space. * is willing to participate in the designated follow-up visits. * must be in good general health. * is able to understand and has voluntarily signed and dated the irb or ec approved informed consent form (icf) prior to initiation of any screening or study-specific procedure. * must be minimum of 18 years and maximum 80 years of age. exclusion criteria: * has body mass index above 35 kg/m2. * has had surgical resection or radiation therapy for cancer or congenital malformations in the larynx, tongue, or throat. * has significant co-morbidities making them unable or inappropriate to participate in this poc study.
assessing arrhythmias after ablation using implantable recorders

Conditions: Atrial Fibrillation

Summary: the purpose of this study is to determine if continuous monitoring using an implantable loop recorder (ie. a device that is placed just underneath the skin of the chest and monitors the heart rate and rhythm) for a year long period after atrial fibrillation ablation may be superior to the current conventional monitoring strategy used by us for determination of atrial fibrillation recurrence (ie. return of the abnormal heart rhythm) and/or arrythmia burden (ie. how long the abnormal rhythm continues or how often the rhythm occurs). some data suggests that continuous monitoring over longer periods may be better in identifying recurrence of atrial fibrillation after ablation and thus assist in its overall management. the device being used for this study is the reveal xt, which, is currently fda approved for monitoring all varieties of cardiac rhythm disorders including atrial fibrillation.


Eligibility criteria:
inclusion criteria: * greater than 18 years * undergoing ablation for atrial fibrillation at the university of pennsylvania exclusion criteria: * patients with already implanted devices, including pacemakers, implantable cardiac defibrillators and cardiac resynchronization devices

Keywords: atrial fibrillation a-fib af persistent permanent pulmonary vein isolation ablation
performance of glass-ionomer cements: 2-year follow-up

Conditions: Dental Caries

Summary: the purpose of this randomized clinical trial was evaluate the performance of two conventional glass-ionomer cements in the pit and fissure sealing and atraumatic restorative treatment in high caries risk children.

sealants were applied on sound permanent first molars by "press finger technique" and carious deciduous molars that required either class i or class ii restorations were restored according to manufacturers' recommendations in order to caries prevention and control.

Eligibility criteria:
inclusion criteria: * volunteers that having at least two permanent first molars of opposite sides of the mouth, erupted in the oral cavity, caries-free and high-risk disease (presence of white spots, history of caries, plaque in smooth surfaces and gingivitis); * children who had one or two bilateral matched pairs of carious deciduous molars that required either class i or class ii restorations. exclusion criteria: * children who did not meet the minimum requirements for the achievement of sealants or parents / guardians did not agree to participate; * no history of spontaneous pulpal pain.

Keywords: glass-ionomer cement atraumatic restorative treatment pit and fissure sealants
a study of aflibercept administered in combination with pemetrexed and cisplatin in participants with advanced carcinoma

Conditions: Advanced Carcinoma; Non-small Cell Lung Cancer

Summary: the purpose of the study was to determine whether the combination of aflibercept, pemetrexed and cisplatin is safe and effective in treating non-small cell lung cancer (nsclc).

the study was conducted in two phases. in phase 1, patients with advanced cancer received different doses of aflibercept in combination with approved doses of pemetrexed and cisplatin. the objective of phase 1 was to determine the safest dose of the combined study medications. this dose was administered to patients with previously untreated nsclc in phase 2. the phase 2 portion of the study determined if the combination is effective in treating nsclc.

Eligibility criteria:
inclusion criteria: * confirmation of cancer by biopsy (tissue sample) * phase 1: patients with advanced or metastatic disease that have failed conventional therapy * phase 2: patients with previously untreated nsclc, excluding squamous cell histology and cavitating lesions * age ≥18 years * eastern cooperative oncology group (ecog) performance status 0-1 * adequate renal, liver and bone marrow function. * negative pregnancy test (serum or urine) in females of childbearing potential within 7 days of the initial dose of aflibercept * ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures * institutional review board (irb) approved, signed and dated informed consent form exclusion criteria: * prior treatment with study medications * untreated, symptomatic, or progressive central nervous system cancer and/or spinal cord compression. patients with treated brain metastases must have been without symptoms for at least 3 months * surgery up to 4 weeks prior to the initial administration of aflibercept and/or incomplete wound healing * anti-vegf therapy up to 4 weeks prior to the initial administration of aflibercept (for phase 1 only) * chemotherapy up to 4 weeks prior to the initial administration of aflibercept (for phase 1 only) * other investigational treatment up to 4 weeks prior to the initial administration of aflibercept * any of the following up to 6 months (24 weeks) prior to the initial administration of aflibercept: * severe cardiovascular disease or event * cerebrovascular accident, transient ischemic attack, or moderate to severe peripheral neuropathy * erosive esophagitis or gastritis, infectious or inflammatory bowel disease, and diverticulitis * deep vein thrombosis, pulmonary embolism, or other clotting event * episode(s)of moderate to severe, continuous bleeding * breast-feeding or pregnancy

Keywords: advanced cancer lung cancer nsclc non-small cell lung cancer aflibercept chemotherapy