Kornimate/medical-research-clean huggingface dataset:
diaphragm plication in adults with phrenic nerve paralysis

Conditions: Phrenic Nerve Paralysis

Summary: the purpose of the study is to investigate the impact of unilateral or bilateral diaphragm plication in a prospective randomised controlled way on symptoms, pulmonary function including gas exchange, respiratory muscle strength, exercise capacity and breathing during sleep in patients with proven uni- or bilateral phrenic nerve paralysis present for at least 1 year without any evidence of spontaneous recovery.


Eligibility criteria:
inclusion criteria: * uni- or bilateral diaphragmatic paralysis due to phrenic nerve paralysis present for at least 1 year * with reduced vc, at least in supine position and no significant change in vc for at least 6 months * at the time of randomisation symptomatic patient, defined by one of the following symptoms: not able to sleep in supine position or exertional dyspnoea exclusion criteria: * no informed consent obtained * other disease that may interfere with the evaluation of pulmonary function or the exercise capacity: copd, parenchymal lung disease on the thoracic x-ray, documented ischemic heart disease or left heart failure, active rheumatological disease, severe orthopaedic problems,.... * abnormal neuromuscular clinical investigation (apart from diaphragmatic dysfunction) and/or abnormal electromyography of the limbs compatible with generalized neuromuscular disease * known diseases resulting in abnormal blood coagulation * proven oncological origine of the phrenic nerve paralysis * age below 18 yrs old
determining metabolic effects of valproate and antipsychotic therapy

Conditions: Schizophrenia

Summary: this study will determine the metabolic processes responsible for high levels of blood glucose, metabolism disorders, and weight gain in people with schizophrenia who have been treated with antipsychotic medications in combination with valproate.

this project aims to study the whole-body metabolic processes responsible for hyperglycemia, dyslipidemia and increased adiposity in schizophrenia patients treated with antipsychotic medications in combination with valproate. the project hypothesizes that combined treatment with valproate and antipsychotic medications will decrease insulin sensitivity at the level of skeletal muscle, liver and adipose tissue, in comparison to antipsychotic monotherapy. the decrease in insulin sensitivity is hypothesized to be associated with defects in glucose and lipid metabolism and increased adiposity treatment effects of antipsychotic/valproate combination therapy on different components of insulin secretion and action, and treatment effects on abdominal versus peripheral adiposity, are unknown despite the availability of gold-standard methods and the prognostic significance of these issues. relevant data are needed to target basic research, to identify the potential for acute and long-term complications, and to plan therapeutic interventions. the following specific aims will be addressed in non-diabetic schizophrenia patients treated with atypical antipsychotics who will be randomized to open label treatment with either valproate or no adjuvant. evaluations are performed at baseline and 3 months of treatment.

Eligibility criteria:
inclusion criteria: * meets dsm-iv criteria for schizophrenia, any type, treated with the same antipsychotic for at least 6 months * no antipsychotic medication dose changes for 1 month, and no other medication changes for 1 month prior to study entry exclusion criteria: * meets dsm-iv criteria for substance abuse within 3 months of study entry * involuntary legal status (as per missouri law) * any serious medical disorder that may confound the assessment of relevant biologic measures or diagnosis, including: significant organ system dysfunction, metabolic diseases, type 1 or 2 diabetes mellitus, pregnancy, endocrine disease, coagulopathy, anemia, or acute infection * currently taking more than one antipsychotic medication * currently taking prescription medications (except certain psychotropic medications as discussed below), including oral contraceptive pills, any glucose lowering agent, lipid lowering agent, exogenous testosterone, recombinant human growth hormone, or any other endocrine agent that might confound substrate metabolism

Keywords: diabetes metabolic
screening for nei clinical studies

Conditions: Conjunctivitis; Iritis; Keratitis; Retinitis; Uveitis

Summary: this screening protocol is designed to facilitate patient recruitment to national eye institute (nei) clinical research studies. patients must meet specific requirements of a research study; this protocol serves as a first step for admitting patients to an appropriate program. candidates may have a diagnosed or undiagnosed eye condition. they will be screened with a medical history, physical examination, eye examination and blood test. other screening procedures may include routine laboratory tests, non-invasive imaging, and questionnaires. the eye examination includes measurement of eye pressure and dilation of the pupils to fully examine the lens, vitreous and retina. specialized eye tests will be done only if needed to determine eligibility for a specific study. when the screening is completed, patients will be informed of their options to participate in a study. patients who are found ineligible for a current study will be informed of alternative treatments or options. no treatment is offered under this protocol.

this protocol is designed for the screening of patients with either diagnosed or undiagnosed conditions, and serves as a first step for individuals who may be eligible, and wish to participate in nei- national eye institute clinical research studies. each individual will be thoroughly evaluated during the screening process to determine if they are suitable candidates for inclusion in any of the nei ongoing studies. the screening evaluation will include past and current medical histories, and an appropriate physical examination. other routine diagnostic procedures and tests may also be completed in order to help determine a subject's eligibility. these tests and procedures are of minimal risk and will be described in more detail in section iii: "study procedures". once the screening process is completed and their eligibility is assessed, the subjects will be informed of their options to participate in one or more of the current clinical research studies. if no appropriate protocol is identified, recommendations for other treatment options may be given to the individual, their primary doctor, or referring physician.

Eligibility criteria:
* participants will be able to enroll if they: 1. have a diagnosed ocular inflammatory eye disease; or 2. have an unusual, interesting or unknown ocular condition that requires the establishment of a diagnosis; and 3. have the ability to understand and sign an informed consent or have a legal parent/guardian with the ability to do the same. 2.2 exclusion criteria participants will be unable to enroll if they: 1. have no ocular medical conditions; or 2. are unwilling or unable to cooperate with the procedures.

Keywords: uveitis conjunctivitis iritis retinitis keratitis screening protocol ocular immunology inflammation eye inflammation
clinical study on zirconia bridges

Conditions: Missing Teeth

Summary: to evaluate the clinical performance and survival rate of nobelproceratm bridge shaded zirconia on natural teeth in the posterior region for a period of 5 years. the working hypothesis of this clinical study is that industrial centrally produced 3- or 4-unit bridges of shaded yttrium-oxide partially-stabilized (y-tzp) zirconia (nobelproceratm shaded zirconia) in combination with a veneering ceramic material will show sufficient cda ratings (80% r+s) and a sufficient survival rate (93%) after 5 years in comparison with a reference level of 95%.


Eligibility criteria:
inclusion criteria: the subject must be at least 18 (or age of consent), and less than 70 at the time of inclusion. * the subject is healthy and compliant with good oral hygiene * the subject is in need of a posterior fixed partial denture restoration of up to 4 units distal of the canines in the maxilla or mandible. * the subject shall have a stable occlusal relationship with a fully restored, fixed opposing dentition. * obtained informed consent from the subject the subject should be available for the 5-year term of the investigation. * no apical disorder or inflammation of abutment teeth, adjacent and opposing teeth. * good gingival / periodontal / periapical status of restoring, opposing and adjacent teeth. healed situation of soft tissue augmentation is allowed. * the subject should be available for the 5-year term of the investigation. exclusion criteria: * the subject is not able to give her/his informed consent to participate. * alcohol or drug abuse as noted in patient records or in patient history. * reason to believe that the treatment might have a negative effect on the patient's total situation (psychiatric problems), as noted in patient records or in patient history. * an existing condition where acceptable retention of the restoration is impossible to attain * mobility of the tooth to be restored. * pathologic pocket formation of 4 mm or greater around the tooth to be restored * severe bruxism or other destructive habits * amount of attached soft tissue is insufficient (no attached gingiva on the buccal side of the tooth). * health conditions, which do not permit the restorative procedure

Keywords: zirconia crown
pushing behaviors in individuals post-stroke

Conditions: Stroke

Summary: some individuals demonstrate pushing behaviors after having a stroke. the purpose of this study is to see if there are immediate changes in pushing behaviors in individuals who have had a stroke before and after sitting in a wheelchair, walking on the treadmill, and walking overground. the investigators do not think there will be a change with sitting in the wheelchair, but the investigators think there may be an improvement in pushing behaviors after walking training.

the study population of interest is primarily individuals in inpatient rehabilitation.

Eligibility criteria:
inclusion criteria: * score \>0 in each subsection of the scale for contraversive pushing * admitted to the rehabilitation institute of chicago inpatient rehabilitation setting * stroke within previous 180 days * consent to participate in the study * ambulating greater than 150' at a time prior to stroke exclusion criteria: * other neurologic diagnoses * weight bearing precautions, orthopedic injuries, or other medical co-morbidities that prevent adherence to the study protocol

Keywords: stroke pusher syndrome lateropulsion pushing behaviors burke lateropulsion scale
ascending aortic dilation in biav after tavr

Conditions: Aortic Valve Stenosis

Summary: this study sought to evaluate changes in ascending aorta size after transcatheter aortic valve replacement (tavr) in patients with bicuspid aortic valve (biav) compared with patients with tricuspid aortic valve (tav).

the growth rate of ascending aorta was calculated as annual growth rate using baseline and the last echocardiography. the difference in ascending aorta growth rates between the two groups (biav and tav) were analyzed by independent t-test.

Eligibility criteria:
inclusion criteria: * severe as who underwent tavr exclusion criteria: * ascending aorta more than 50mm
a study to learn about the study medicine pf-07321332 and ritonavir in adult healthy chinese participants.

Conditions: Healthy Participants

Summary: the purpose of this phase 1 clinical trial is to help us understand how the drug is changed and eliminated from your body after you take it, the safety, and the the extent to which dise effects can be tolerated of pf-07321332 when pf-07321332 and ritonavir are given to healthy adult chinese participants.


Eligibility criteria:
inclusion criteria: * healthy chinese participants * no clinical relevant abnormalities * body mass index (bmi):17.5-28 exclusion criteria: * any clinical significant illness * history of alcohol abuse * use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days prior the first study dose * abnormal clinical lab tests: aspartate aminotransferase (ast), alanine aminotransferase (alt), total bilirubin, estimated glomerular filtration rate (egfr) * abnormal vital signs, such 12-electrocardiogram (ecg), blood pressure and pulse rate * blood donation within 60 days * history of human immunodeficiency virus (hiv), hepatitis b surface antigen (hbsag), hepatitis b core antibody (hbcab), hepatitis c antibody (hcvab) * other medical or psychiatric may inappropriate for the study

Keywords: severe acute respiratory syndrome coronavirus 2 (sars-cov-2) coronavirus disease 2019 (covid-19)
a retrospective study to evaluate the effectiveness of the ulthera system

Conditions: Skin Laxity; Wrinkles

Summary: up to 120 subjects within the study site's practice who have already had an ultherapy™ treatment to the face and neck will be enrolled to monitor treatment effectiveness. follow-up visits will occur at 90 and 180 days post-treatment. study images will be obtained at each follow-up visit.

this is a retrospective, single-center clinical trial to evaluate the efficacy of the ulthera system for non-invasive treatment of skin texture and laxity six months after treatment. global aesthetic improvement scale scores, patient satisfaction questionnaires, and quality of life questionnaires will be obtained.

Eligibility criteria:
inclusion criteria: * male or female, age 25-85 years. * subject in good health. * received ultherapy™ treatment prior to or on october 1, 2011, and must have had pre-treatment baseline photographs taken. * willingness and ability to comply with protocol requirements, including returning for follow-up visits. * absence of physical or psychological conditions unacceptable to the investigator. exclusion criteria: * presence of an active systemic or local skin disease that may affect wound healing. * significant scarring in areas treated. * open wounds or lesions in the areas treated. * severe or cystic acne on the areas treated. * inability to understand the protocol or to give informed consent.

Keywords: ulthera® system ultherapy™ treatment ulthera, inc. ultrasound treatment for skin tightening
genetic risk estimations for influencing decision making in women at high risk of breast cancer, genre 2 study

Conditions: Breast Cancer

Summary: the primary aim of this study is to determine if the addition of an individual polygenic risk score (prs) in addition to the breast cancer risk assessment tool (bcrat) or tyrer-cuzick (ibis) score will aid women at risk of breast cancer in making a decision to take (or not take) medications to prevent breast cancer.

this is a minimal risk prospective multisite study with a single arm incorporating the prs into a standard breast cancer risk reduction consultation, followed by annual surveys over 10 years to determine if and how the availability of the prs influenced patient decisions regarding preventive medicine and medication compliance. because women know beforehand that the prs is pending, study participants will be advised that a final decision to take preventive medicine must be deferred until after the prs results are made available. nevertheless, a survey of understanding of risk and benefit and assessment of willingness to take preventive medicine will be done prior to receiving the prs results and then another survey will be completed after receiving the prs score.

Eligibility criteria:
inclusion criteria: * women \>= 35 years old and =\< 75 years old with at least one of the following: * a national cancer institute (nci)-bcrat 5 year risk of \>= 3% which corresponds to the level in which there is moderate evidence of treatment benefit outweighing risk according to the united states (us) preventative services task force * ibis (tyrer-cuzik) score for the 10 year risk of breast cancer of \>= 5% * history atypical ductal hyperplasia or atypical lobular hyperplasia with a bcrat \>= 3% or ibis \>= 5% * history of lobular carcinoma in situ with a bcrat \>= 3% or ibis \>= 5% or * women \>= 18 years old or =\< 75 years old with a brca 1 or 2 mutation, chek 2, palb 2, atm, or other hereditary breast mutation carrier per investigator * willing and able to provide an email address to receive study surveys * able to participate in all aspects of the study * understand and sign the study informed consent exclusion criteria: * women whose bcrat falls below the threshold (\<3 % 5 year risk) of moderate benefit according to the us preventative task force and women whose ibis score is \<8% for the 10 year risk * women with known contra-indications to tamoxifen, raloxifene ,exemestane, or anastrazole * current or prior use of tamoxifen, raloxifene, exemestane or anastrazole * unable to give informed consent * prior history of invasive breast cancer, ductal carcinoma in situ or other breast cancers * at high risk due to prior radiation therapy to the chest * women who are pregnant or breastfeeding * prior risk reducing or prophylactic mastectomy * unwilling or unable to provide an email address for study surveys to be sent to * subject has a known history or any condition or factor judged by the investigator to preclude participation in the study or which might hinder adherence

Keywords: bcrat ibis breast cancer brca1 brca2 brca brca 1/2 tyrer-cuzick cedm prs
efficacy and safety of maa868 in patients with atrial fibrillation

Conditions: Atrial Fibrillation

Summary: the purpose of this study is to evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of maa868 compared to apixaban in patients with atrial fibrillation.


Eligibility criteria:
inclusion criteria: * male and female patients ≥ 55 and \< 85 years old * body weight between 50 and 130 kg inclusive * atrial fibrillation or atrial flutter, as documented by electrocardiography * cha2ds2-vasc risk score ≥ 2 for male and female patients. male patients with cha2ds2vasc risk score of 1 can be included if anticoagulation therapy is warranted. * either anticoagulant-naïve or receiving a stable treatment of a recommended dose of a new oral anticoagulant (noac) over the 8 weeks prior to screening. exclusion criteria: * history of stroke, transient ischemic attack or systemic embolism * history of major bleeding during treatment with an anticoagulant or antiplatelet therapy in the last 12 months * history of traumatic or non-traumatic intracranial, intraspinal or intra-ocular bleeding * known bleeding diathesis or any known active bleeding site at screening or baseline * family history of bleeding disorder * known active gi lesions predisposing to bleeding events * myocardial infarction, unstable angina pectoris or coronary artery bypass graft (cabg) surgery within 12 months prior to the screening period * known hemodynamically significant valvular heart disease * uncontrolled hypertension defined as sbp/dbp ≥ 160/100 mmhg at the screening visit * heart failure nyha class iv in the 3 months prior to the screening visit * dual antiplatelet therapy. treatment with a p2y12 inhibitor or low dose aspirin (≤ 100 mg/d) is allowed but not both. * severe renal impairment (creatinine clearance \< 30 ml/min) at the screening visit

Keywords: maa868 apixaban atrial fibrillation anticoagulant factor xi d-dimer systemic thromboembolic events
immediate postoperative adjuvant hormonal treatment in high risk localised or locally advanced prostate cancer patients.

Conditions: 2 Years PSA Recurrence Rate

Summary: the primary objective is to assess the efficacy of immediate postoperative adjuvant hormonal treatment according to 2 year psa recurrence rate in high risk localised or locally advanced chinese prostate cancer patients.the secondary objective is to assess the quality of life（qol）of the high risk localised or locally advanced chinese prostate cancer patients with immediate postoperative adjuvant hormonal treatment and get the information of immediate postoperative adjuvant hormonal treatment (including the regimen, dosage and duration).


Eligibility criteria:
inclusion criteria: * localised with one of any high recurrence risk factors(gleason score≥8 or preoperative serum psa≥20ng/ml), or locally advanced(t≥pt3、n0m0 and any t、n（+）m0 ) chinese prostate cancer patients confirmed histologically through radical prostatectomy either with laparoscopy or laparotomy within 1 month after surgery. before the patient recruitment, the investigator has decided to prescribe immediate postoperative adjuvant hormonal treatment to the patient according to the chinese routine practice. * provision of written informed consent prior to any study specific procedures. exclusion criteria: * patients must not enter the study if any of the following exclusion criteria are fulfilled * have used neoadjuvant hormonal treatment prior to the surgery.

Keywords: prostate cancer adjuvant hormonal
single intravenous administration of tb-402 for the prophylaxis of venous thromboembolic events (vte) after total knee replacement surgery

Conditions: Total Knee Replacement Surgery

Summary: the purpose of this study is to evaluate the safety and efficacy of a single administration of tb-402 for the prevention of vte in patients undergoing knee replacement surgery.

currently available anticoagulant therapies for the prevention of vte include low molecular weight heparins, pentasaccharides and vitamin k antagonists, all of which have inherent limitations(1-3). improved anticoagulant agents are therefore required(4). a novel antithrombotic agent requires demonstration of both efficacy and safety in relevant populations. phase ii studies are frequently performed in patients undergoing total hip replacement and/or total knee replacement because of the high and well documented incidence of deep vein thrombosis in the absence of adequate thromboprophylaxis(5-7). in this study, we assess the safety and efficacy of tb-402, a novel antithrombotic agent that partially inhibits factor viii, in the prevention of vte in patients undergoing total knee replacement surgery.

Eligibility criteria:
inclusion criteria: * male or female patients aged \> 18 and \< 80 years old * female patients should be post menopausal * patients undergoing primary elective total knee replacement surgery * written informed consent obtained from the patient (or a legally acceptable representative) prior to inclusion in the study * willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures exclusion criteria: * body weight \ 100 kg * patients undergoing a hemiarthroplasty, surface repair or revisionary surgery of the knee * confirmed symptomatic deep vein thrombosis or pulmonary embolism within the past year * anticipated use of indwelling intrathecal or epidural catheter for more than 4 h after surgery or during the entire study * uncontrolled hypertension (sbp\>160 mm hg or dbp \> 100 mm hg) * history of intracranial or intraocular bleeding. history of gastrointestinal and/or endoscopically verified ulcer disease within the past year

Keywords: tkr vte dvt
does oral baclofen improve care and comfort in spastic children in nursing homes?

Conditions: Cerebral Palsy

Summary: baclofen is a drug that reduces the muscle stiffness. in disabled children that have very stiff muscles, the stiffness and secondary changes in the joints may cause discomfort and pain. in this study we will check if treatment with baclofen reduces pain in disabled children with stiff muscles.


Eligibility criteria:
inclusion criteria: * cerebral palsy nursing homes children ages 1-18 years spastic quadriplegia exclusion criteria: * active epilepsy severe truncal hypotonia

Keywords: nursing homes children ages 1-18 years spastic quadriplegia