Kornimate/medical-research-clean huggingface dataset:
study of the efficacy and safety of parsaclisib in participants with primary warm autoimmune hemolytic anemia

Conditions: Warm Autoimmune Hemolytic Anemia (wAIHA)

Summary: the purpose of this study is to evaluate the efficacy and safety of parsaclisib compared with placebo in participants with primary warm autoimmune hemolytic anemia (waiha),

prospective participants must have primary waiha as well as other protocol-defined criteria. after participants have been determined to be eligible for the study, they will be randomized to 2:1, with stratification factor of corticosteroid dose and hemoglobin (hgb \<9 g/dl or ≥ 9 g/dl). once a participant has completed the week 24 assessments in the double-blind period, the participant will have the opportunity to receive parsaclisib in the open-label treatment which will last up to another 24 weeks. participants may then continue to receive parsaclisib in a long-term extension period.

Eligibility criteria:
inclusion criteria: * diagnosis of primary warm aiha. * participants who have at least 1 unsuccessful prior therapy for warm aiha or unable to receive or tolerate other therapies. * hemoglobin ≥ 6.5 to \< 10 g/dl with symptoms of anemia at screening. * facit-f score ≤ 43 at screening. * willingness to avoid pregnancy or fathering children. * willingness to receive pjp prophylaxis. * further inclusion criteria apply. exclusion criteria: * women who are pregnant, breastfeeding or who are planning a pregnancy. * diagnosis of other types of aiha (cad, cold agglutinin syndrome, mixed-type aiha or paroxysmal cold hemoglobinuria). * secondary warm aiha from any cause or diagnosis of evans syndrome. * splenectomy less than 3 months before randomization. * participants with a history or ongoing significant illness as assessed by the investigator. * participants with a current of medical history of a malignancy within the past 5 years except basal or squamous cell skin cancer that has been removed and considered cured, or superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy. * participants know to be infected with hiv, hepatitis b, or hepatitis c. * chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment or exposure to a live vaccine. * participants with laboratory values outside of the protocol defined ranges. * further exclusion criteria apply.

Keywords: warm autoimmune hemolytic anemia (waiha)
study of cabozantinib in combination with abiraterone in chemotherapy-naïve subjects with bone-metastatic castration-resistant prostate cancer

Conditions: Prostate Cancer; Castration Resistant Prostate Cancer; Prostatic Neoplasms

Summary: this study is designed to evaluate the safety and efficacy of combining abiraterone (with prednisone) with cabozantinib in chemotherapy-naïve subjects with bone-metastatic castration-resistant prostate cancer (crpc).


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed adenocarcinoma of the prostate. * must be surgically or medically castrated (serum testosterone levels less than or equal to 50 ng/dl) * must have castration-resistant prostate cancer (crpc) with disease progression during lhrh therapy or after a surgical bilateral orchiectomy. * bone metastasis related to prostate cancer * adequate organ and marrow function * capable of understanding and complying with the protocol requirements and signed the informed consent document * sexually active subjects and their partners must agree to use medically accepted methods of barrier contraception (eg, male condom or female condom) as well as one other medically accepted method of contraception during the course of the study treatment and for 4 months after the last dose of study treatment. exclusion criteria: * any prior treatment with abiraterone, enzalutamide, or any investigational agents blocking androgen receptor (ar) or androgen synthesis. * any prior treatment with cabozantinib or participation in a prior clinical trial of cabozantinib. * any prior cytotoxic therapy (including estramustine) or biologic therapy for the treatment of prostate cancer (a few exceptions will be allowed) * any prior radionuclide therapy (eg, samarium 153, strontium 89, alpharadin) * use of investigational agent within 28 days * any pathological finding consistent with small cell carcinoma of the prostate * known brain metastases or cranial epidural disease * diagnosis of another malignancy within 2 years, except for superficial non-melanoma skin cancers, or localized, low grade tumors deemed cured and not treated with systemic therapy

Keywords: crpc castration resistant prostate cancer prostate cancer
sexual health and breast cancer: developing appropriate education for women going through treatment

Conditions: Breast Cancer Female; Sexual Dysfunction

Summary: the purpose of this study is to assess the acceptability, appropriateness, and feasibility of a educational video series for patients going through breast cancer treatment.

this is a prospective, mixed methods pilot study to evaluate the acceptability, appropriateness, and feasibility of a novel educational video series for patients going through breast cancer treatment. the video series addresses topics such as what to expect from breast surgery, how to prepare for breast surgery, treatment effects of breast cancer therapies, and mitigation and communication strategies for navigating breast cancer treatment.

Eligibility criteria:
inclusion criteria: * stage i-iii invasive breast cancer within one month of initial multi-disciplinary clinic visit or surgical consultation * ability to complete survey material independently * able to read and speak english * willingness to comply with study material and procedures exclusion criteria: * age \< 18 years old * stage 0 or iv breast cancer * non-breast cancer diagnoses * history of anti-hormonal therapy, chemotherapy, or radiotherapy not related to breast cancer * prior breast cancer diagnosis

Keywords: breast cancer sexual health educational video
post-market clinical follow-up performance and safety study of etermis 3 and 4 in the face

Conditions: Correction of Facial Wrinkles/Folds; Facial Volume Enhancement

Summary: to confirm the clinical performance of etermis 3 and etermis 4 based on the blinded investigator´s assessments on the respective merz aesthetics scales from day 0 (d0) pre-injection to month 6/7 (depending on touch up) visit for nasolabial folds and marionette lines and from d0 pre-injection to month 3/4 (depending on touch up) visit for upper and lower lip fullness.


Eligibility criteria:
inclusion criteria: * subjects seeking hyaluronic acid dermal filler treatment to redefine/volumize/correct at least two of the indicated facial areas: * nasolabial folds * marionette lines * upper and lower lip fullness exclusion criteria: * subjects that have already been injected with non-resorbable filler, or that have recently been treated with any dermal filler in the region to be treated in the study * subjects with known sensitivity to hyaluronic acid-based products
intranasal dexmedetomidine for adult patients undergoing phacoemulsification cataract surgery

Conditions: Cataract; Preoperative Sedation

Summary: the investigators designed this study to examine whether the intranasal dexmedetomidine, as a preoperative drug, could improve the satisfaction of adult patients undergoing phacoemulsification cataract surgery.

this is a prospective, double-blind, randomized controlled study. patients over 65 years old were selected for phacoemulsification combined with intraocular lens implantation under topical anesthesia. participants were randomly divided into two groups: dextrometropine group and placebo group, and were masked until the end of this study. approximately 45 - 60 minutes before surface anesthesia, patients in the dextrometropine group were given dextrometropine (1.0μg.kg-1), patients in the placebo group were given the same amount of saline. the primary end point of this study is the patient satisfaction. patient satisfaction was assessed using a 3-point satisfaction score on a scale. anxiety of perioperative patients was assessed using a 4-point anxiety score on a scale. secondary endpoints include blood pressure, heart rate, blood oxygen saturation, operation time, operative complications and adverse drug reactions.

Eligibility criteria:
inclusion criteria: cataract patients over 65 years scheduled for elective phacoemulsification and intraocular lens implantation in department of ophthalmology, guangzhou first people's hospital will be recruited in this study. recruited patients shall own normal intelligence and understanding capability and their best corrected visual acuity more than 0.1 in either eye. exclusion criteria: 1) a known allergy or hypersensitivity to dextrometropine or other anesthetics; 2) a previous history of heart disease; 3) a heart rate (hr) \<45 beats per minute (bpm); 4) a second- or third-degree atrioventricular block; 5) patients on antihypertensive drugs, such as α-methyldopa, clonidine, or other α2-adrenergic agonists; 6) asthma; 7) sleep apnea syndrome; 8) organ dysfunction; 9) patients with mental illness; and 10) the long-term use of sedatives and analgesics. -

Keywords: cataract preoperative sedation dextromethoridine patient satisfaction
impact of yo-yo sleep on cardiometabolic health

Conditions: Cardiometabolic Syndrome; Obesity

Summary: the goal of this clinical trial is to test the impact of repeated intermittent short sleep, with short sleep maintained 5 days per week followed by 2 days of prolonged sleep, compared to daily adequate sleep, on energy balance and cardiometabolic risk. a secondary goal of this research is to determine if maintaining a constant midpoint of sleep while undergoing intermittent short sleep, leads to better outcomes than intermittent short sleep with a 2-hour delay in sleep midpoint. the aims of this research will be tested in the context of a 3-group, parallel-arm, outpatient intervention of 4 weeks in duration, in young-to-middle-aged adults (aged 18-49 years).

a large portion of the u.s. adult population reports insufficient sleep on a nightly basis. it has been shown that sustained insufficient sleep leads to adverse cardiometabolic risk profile and positive energy balance. however, sleep patterns in real life are not consistent over weeks. individuals not obtaining sufficient sleep during the week may compensate by sleeping longer on weekends. the differences in sleep duration between week and weekend nights is approximately 1 hour, mostly due to delaying wake times rather than advancing bedtimes. a drawback of such behaviors is resultant change in sleep midpoint, which has been associated with adverse cardiometabolic health and obesity. however, very few studies have attempted to determine whether recovery sleep on weekends results in reversal of adverse health effects of insufficient sleep during the week. available studies suggest that recovery sleep does not revert health markers to pre-sleep restriction (sr) levels. but these studies are short, usually involving only one cycle of sr followed by recovery sleep, and fail to use appropriate and robust statistical methods. therefore, the goal of the current investigation is to evaluate the impact of repeated intermittent short sleep, with short sleep maintained 5 days/week followed by 2 days of recovery sleep, relative to daily adequate sleep, on energy balance and cardiometabolic risk markers. a secondary goal of this research is to determine if maintaining a constant sleep timing while undergoing intermittent short sleep, leads to better outcomes than intermittent short sleep in conjunction with shifts in sleep times.

Eligibility criteria:
inclusion criteria: * aged 18 to 49 years * bmi 20-29.9 kg/m2 * habitually sleeping 7-9 hours/night without sleep aids or naps exclusion criteria: * sleep disorders * psychiatric disorders (including eating disorders) and seasonal affective disorder * pregnancy (current/prior year) * breastfeeding * smokers (any cigarette smoking or ex-smokers \<3years) * diabetes * elevated blood pressure, taking beta-blockers * individuals taking anti-coagulants or anti-platelets * recent weight change or participation in a weight loss program or have ever had bariatric surgery or other weight loss or gastrointestinal procedure. * travel across time zones; shift work (non-traditional hours)

Keywords: sleep circadian rhythms cardiometabolic health
blood folate and homocysteine levels following administration of folic acid according to different daily dosing schedules:a simulation of food fortification

Conditions: Neural Tube Defects - Spina Bifida and Anencephaly

Summary: the aim of this study is to examine whether the same total daily dosage of folic acid, when taken as a single daily dose or as multiple divided doses throughout the day, results in different blood folate and homocysteine levels at the conclusion of the study. further, a comparison of blood folate and homocysteine levels among women taking daily low-dosage (100mcg) and standard- dosage (400mcg) folic acid with those of women taking daily or weekly high-dosage (4000mcg) folic acid will be conducted.


Eligibility criteria:
inclusion criteria: -women who have delivered a baby two to four years ago, whose child is still alive, who are not breast-feeding, who are not pregnant or planning to become pregnant within the next 9 months following enrollment, who are using an iud for contraception, and who have not taken vitamin supplements during the past 3 months exclusion criteria: -women who have not delivered a baby two to four years ago, whose child is deceased, who are breast-feeding, who are currently pregnant or planning to become pregnant within the next 9 months following enrollment, who are not using an iud for contraception, and who have taken vitamin supplements during the past 3 months
a study to evaluate luspatercept (ace-536) in chinese participants who require regular red blood cell transfusions due to beta (β)-thalassemia.

Conditions: Beta-thalassemia

Summary: the purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of luspatercept plus best supportive care (bsc) versus placebo plus bsc in participants who require regular red blood cell transfusions due to β-thalassemia.


Eligibility criteria:
inclusion criteria: * participant is willing and able to adhere to the study visit schedule (for example, not scheduled to receive hematopoietic stem cell transplantation \[hsct\]) and other protocol requirements. * participant has documented diagnosis of β-thalassemia or hemoglobin e/β-thalassemia (β-thalassemia with mutation and/or multiplication of alpha (α) globin is allowed). * participant is regularly transfused, defined as: 6-25 rbc units in the 24 weeks prior to randomization and no transfusion-free period for \>42 days during that period. * participant has eastern cooperative oncology group (ecog) score of 0 or 1. exclusion criteria: * participant has a diagnosis of hemoglobin s/β-thalassemia or α-thalassemia (for example, hemoglobin h). * participant has active hepatitis c virus (hcv) infection as demonstrated by a positive hcvribonucleic acid (rna) test of sufficient sensitivity, or active infectious hepatitis b virus (hbv) as demonstrated by the presence of hepatitis b surface antigen (hbsag) and/or hbvdeoxyribonucleic acid (dna) positive, or known positive human immunodeficiency virus (hiv). * participant has a history of deep venous thrombosis or stroke or thromboembolic events (venous or arterial) requiring medical intervention ≤24 weeks prior to randomization. * participant uses chronic anticoagulant therapy, unless the treatment stopped at least 28 days prior to randomization. anticoagulant therapies used for prophylaxis for surgery or high-risk procedures as well as low-molecular-weight heparin for superficial venous thrombosis and chronic aspirin are allowed. * participant who has emh complications requiring treatment to control the growth of emh mass(es) during the screening period. * participant used immunomodulatory imide drugs (imids) ≤ 24 weeks prior to randomization

Keywords: luspatercept ace-536 transfusion burden
assessment of subsynovial connective tissue thickness in carpal tunnel syndrome

Conditions: Carpal Tunnel Syndrome

Summary: the general aim of this research is to gain insight in the role of ssct in the etiology and progression of cts. we hypothesize that (degenerative) damage of the ssct occurs early on in the pathogenesis of cts. fibrotic damage to the ssct will lead to altered morphology and biomechanical characteristics. this eventually may lead to damage of the median nerve. to examine the ssct an ultrasound technique described by van doesburg et al. 2012 will be used first, the reliability of the us technique to characterize morphology of the ssct will be investigated. secondly, cross-sectional data will be collected in healthy subjects and cts patients to provide descriptive parameters and to describe differences between patients and controls. in the final part a prospective study will be conducted to look at changes of ssct thickness over time and after treatment.


Eligibility criteria:
inclusion criteria: * for cts patients * human adults, 18 years and older * complaints compatible with cts (katz hand diagram\[31\] rating of 'classic', 'probable' or 'possible' or typical clinical signs) * indication for electrodiagnostic testing * informed consent to participate * for healthy subjects * human adults, 18 years and older * negative electrodiagnostic testing and scoring 'unlikely' at katz hand diagram * informed consent to participate exclusion criteria: * pregnancy * history of renal disease, diabetes, chemotherapy, tumors, other neurological diseases (e.g., polyneuropathy), thyroid disease * problems of the upper limb, e.g., degenerative and inflammatory joint disease, gout, tendinopathy at the wrist, acute trauma of the upper limb

Keywords: carpal tunnel syndrome subsynovial connective tissue ultrasound
sertraline and cognitive therapy in depressed alcoholics

Conditions: Alcoholism; Depression

Summary: this study will assess whether individuals treated with sertraline (zoloft) and cognitive behavior therapy will experience improvement with their depression and consume less alcohol than individuals treated with a placebo and cognitive behavior therapy. this is a 12-week, random assignment, placebo-controlled, double-blind study with followup assessments 1 and 3 months after treatment.


Eligibility criteria:
inclusion criteria: * meets criteria for major depressive episode. * meets criteria for alcohol abuse or dependence thirty days prior to entering the study. * has had no more than one previous inpatient medical detoxification. * able to maintain sobriety for ten days. * able to read and understand questionnaires and informed consent. * lives within 50 miles of the study site, has a stable living situation, and a reliable source of collateral reporting. exclusion criteria: * meets criteria for any other psychoactive substance dependence other than nicotine. * any psychoactive substance abuse (other than nicotine or marijuana) within 30 days before beginning of study. * meets criteria for other psychiatric disorders including: panic disorder, obsessive-compulsive disorder, bipolar affective disorder, cyclothymia, schizophrenia, any organic mental disorder, eating disorder, dissociative disorder, or post-traumatic stress disorder. * has evidence of treatment resistant depression defined as more than one previous treatment episode for depression, which can include hospitalization and/or one course of antidepressant medication. * patients may not have been prescribed a specific serotonergic medication within the month prior to study and may not have taken any antidepressant or antipsychotic within the two weeks prior to study. * current use of disulfiram (antabuse) or anti-seizure medications. * clinically significant medical problems: cardiovascular, renal, gastrointestinal, or endocrine problems that would limit participation or limit medication ingestion. * hepatocellular disease. * females who are pregnant, nursing, or not using a reliable form of birth control. * current charges pending for violent crime (excluding dui related offenses). * previous adverse experience with a serotonin reuptake inhibitor. * current homicidal or suicidal ideation.
prophylaxis of acute post-traumatic bacterial endophthalmitis

Conditions: Endophthalmitis; Prophylaxy of Post Traumatic Endophthalmitis; Bacterial Endophthalmitis

Summary: purpose: to evaluate the efficacy of combined intraocular injection of gentamycin and clindamycin in prevention of acute posttraumatic bacterial endophthalmitis (apbe) following penetrating eye injuries. design: multicenter, randomized, double masked, controlled trial. participants: three hundred forty six eyes of 346 patients with penetrating eye injury. method: following primary repair, eyes were randomized to receive a 0.1 ml intracameral or intravitreal injection of 40µg gentamycin and 45µg clindamycin (cases), versus intracameral or intravitreal injection of 0.1ml balanced saline solution (controls). all patients received standard prophylactic antibiotic therapy (systemic, subconjunctival and topical). main outcome measures: occurrence of endophthalmitis within two weeks after primary repair.


Eligibility criteria:
inclusion criteria: * all patients with penetrating eye injuries referred to collaborating institutes for primary repair exclusion criteria: * absence of light perception * presence of endophthalmitis at the time of initial evaluation * total corneal opacity * age under 3 years * severe intracameral hemorrhage * history of intraocular surgery and presence of a corneal ulcer * monocular patients * the better eye in simultaneous bilateral injuries

Keywords: endophthalmitis post-traumatic endophthalmitis bacterial endophthalmitis prophylaxis of endophthalmitis intra ocular injection of antibiotics
mandibular furcation iii regeneration (furc-iii-regen)

Conditions: Furcation Defects; Periodontal Diseases

Summary: teeth with furcation grade iii defects will be treated with open flap debridement and regenerative therapy with biphasic calcium phosphate combined with either enamel matrix proteins or a collagen membrane.


Eligibility criteria:
inclusion criteria: * subject must be ≥ 20 years * subject must have periodontal disease as determined by the world workshop 2017 criteria * subjects must be undergoing periodontal treatment or follow-up and present 1 or more pair of bilateral mandibular molars affected by furcation involvement grade ii with ppd \>4 mm, and the furcation fornix must be below a tangential line from the distal to mesial interproximal crestal bone level * competent to give consent exclusion criteria: the following must not be present at the time of enrolment; * previous radiotherapy to the jaws, current use of chemotherapy, systemic long-term corticosteroid treatment * present or past use of bisphosphonate treatment * pregnant or nursing subjects * patients classified as \> class 2 according to the asa (american society of anesthesiologists) physical status classification * previous surgical therapy of included furcation defects * inability to comprehend and respond to the quality of life questionnaire * dental restorations or prosthesis involving the furcation area * root fractures or suspected infractions * caries lesions in the furcation area * no systemic antibiotic treatment within 3 months prior to intervention