Kornimate/medical-research-clean huggingface dataset:
transfusion in cardiac valve surgery

Conditions: Cardiac Surgery With Cardiopulmonary Bypass; Valve Heart Disease

Summary: this prospective, randomized controlled study is aimed to figure out suitable transfusion threshold in patients undergoing cardiac valve surgery under cardiopulmonary bypass(cpb). patients are randomly assigned to restrictive and liberal transfusion group and receive blood transfusion during and after surgery. compare primary and secondary outcomes of two groups.

patients are randomly assigned to restrictive-threshold group and liberal-threshold group before cardiac group. patients are included in this research when their hct meets 24% during cpb. arterial blood gas analysis will be done in 0.5h, 1.5h, 2.5h, 3.5h...after cpb start and 0.5h before cpb finish. arterial blood gas analysis will be done every 4h in intensive care unit(icu) and everyday in general ward. restrictive-threshold group: the transfusion threshold is hemoglobin(hb) ≤ 6.0g/dl or hct ≤ 18% during cpb; postoperative hb ≤ 7.0g/dl or hct ≤ 21% in icu or general ward. liberal-threshold group: the transfusion threshold is hb ≤ 8.0g/dl or hct ≤ 24% during cpb; postoperative hb ≤ 10.0g/dl or hct ≤ 30% in icu or general ward. if the hb or hct fall below the threshold at any time, 2 unit of blood cells is administered as soon as possible. test hb or hct again, if is under the threshold 2 unit blood cells will be given until reach the threshold.

Eligibility criteria:
inclusion criteria: * all cardiac valve surgical patients undergoing cpb, isolated valve procedures informed consent obtained exclusion criteria: * pregnant or maternal women age less than 18 years or more than 80 years undergo coronary artery bypass or large cardiac vessels procedure emergencies have been attended other researches unable to receive blood for religious reasons drug addict or malignant tumor patient

Keywords: cardiac valve surgery transfusion transfusion threshold
clinical study on the treatment of refractory rheumatoid arthritis with utaa91 injection

Conditions: Rheumatoid Arthritis (RA)

Summary: this clinical trial is designed as a single - arm, open - label, single - center, investigator - initiated early - phase clinical study. the primary objective is to evaluate the safety of utaa91 injection in treating subjects with refractory moderate - to - severe active rheumatoid arthritis.


Eligibility criteria:
inclusion criteria: * aged ≥18 years (inclusive of the boundary value), with no restriction on gender. * expected survival time of at least 3 months. * subjects with refractory moderate - to - severe active rheumatoid arthritis who have failed standard treatment or lack effective therapeutic options. * meet the requirements for liver and kidney function, as well as cardiopulmonary function. * free from severe psychiatric disorders. * able to understand the trial and have signed the informed consent form. exclusion criteria: * a history of malignant tumors other than relapsed/refractory autoimmune diseases (r/r aid) within 5 years prior to screening. * subjects with positive results in virus/syphilis tests. * severe cardiac diseases or unstable systemic diseases. * active or uncontrollable infections requiring systemic treatment within 7 days before administration; evidence of central nervous system invasion at screening. * pregnant or breastfeeding women, female subjects planning to become pregnant within 2 years after cell infusion, or male subjects whose partners plan to become pregnant within 2 years after their cell infusion. * subjects who have received car - t therapy or other gene - modified cell therapies before screening. * subjects who participated in other clinical studies within 1 month before screening. * other conditions deemed unsuitable for enrollment by the investigator.
the efficacy and safety of fe 200486 in treatment of patients suffering from prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of this trial was to select a dose of degarelix (fe 200486). three groups of patients were treated for six months on different doses. the patients had blood samples taken and measured for testosterone in order to determine the most efficient dose to provide fast and sustained castration. the patients came to the clinic for 16 visits and dependent on the blood sample results they were invited to return for additional blood samples on a two weekly basis.

degarelix was not fda regulated at the time of the trial. after completion of the trial degarelix has been approved by the fda and is thus an fda regulated intervention.

Eligibility criteria:
inclusion criteria: * signed informed consent before any trial related activity * proven prostate cancer with a need for endocrine treatment * testosterone level within the normal range for the age exclusion criteria: * previous or current hormonal treatment of prostate cancer * candidate for prostatectomy or radiotherapy * history of severe asthma, anaphylactic reactions or quincke's oedema * hypersensitivity towards any component of fe200486 * cancer disease within the last ten years except for prostate cancer and some skin cancers * presenting with significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, haematological, dermatological or infectious disorder. in addition any other condition such as excessive alcohol or drug abuse that may interfere with trial participation or influence the conclusion of the trial as judged by the investigator * mental incapacity or language barrier * having received an investigational product within the last 12 weeks preceding the trial * previous participation in this trial
evaluation of the effects of pharmaton tablets on mental performance and physical fatigue in nurses working night shift

Conditions: Sleep Disorders, Circadian Rhythm

Summary: the general aim of this study is to assess the effects of pharmaton® caplets on mental performance and physical fatigue in nurses and nursing auxiliaries working night shifts


Eligibility criteria:
inclusion criteria: * male and female nurses and nursing auxiliaries working night shift * age range: 20 to 45 inclusive * bmi range: 18-30 * negative pregnancy test for females * subjects must be free of any clinically significant disease or condition that required a physician's care and/or was to interfere with study evaluation and procedures * clinical laboratory tests within normal limits or, if out of normal range, clinically acceptable to the investigator * negative urine drug screen for drugs at screening * subjects must be willing to give informed consent prior to study enrolment and be able to adhere to restrictions and examination schedules exclusion criteria: * any serious disorder that may interfere with his/her participation to the trial and the evaluation of the safety of the test drug (e.g. liver and/or renal disease, hypervitaminosis a, psychic disorder, etc.) and/or treatment with chronic medication * pre-treatment (less than 2 weeks prior to inclusion in this trial) and/or concomitant treatment with any drug that may influence the trial symptomatology and may interfere with evaluation of the safety of the test drug (e.g. vitamins and minerals supplementation) * individuals drinking more than 40 g alcohol/day (glass of 12.5 cl of wine 10° = 12 g; glass of 4 cl of aperitif 42° = 17 g; glass of 25 cl of beer 3° = 7.5 g; glass of 25 cl of beer 6° = 15 g); alcohol and drug abuse according to diagnostic and statistic manual, version iv (dsm-iv) * individuals drinking more that 6 cups of coffee or tea/day * individuals smoking more than 10 cigarettes/day * female volunteers in child-bearing age not using adequate means of birth control (contraceptive pills, intrauterine device (iud), sterilization) * pregnancy and/or lactation * relevant allergy or known hypersensitivity to the investigational product or its excipients * individuals taking or having taken recently other vitamins and minerals supplementation * individuals with a current disorder likely to modify eeg recordings and/or computerized cognitive testing * individuals having a history of cancer * participation in another clinical trial within the last 3 months prior to the start of the study and concurrent participation in another clinical trial * individuals without health insurance
comparing the pain experience between patients who have and who have not undergone dermatologic procedures

Conditions: Pain

Summary: the purpose of this study is to compare the pain experience of patients who have not had dermatologic procedures (previously "unexposed") using energy devices (lasers, radiofrequency, ultrasound, etc.) with patients who have previously had procedures (previously "exposed") using energy devices. based on previous clinical encounters, individuals with no prior experience with cosmetic procedures appear to experience more pain. however, no study to date has thoroughly examined this observation. as a result, this study has been designed to find a possible difference in pain perception between previously exposed and unexposed patients undergoing cosmetic procedures using energy devices.

twenty subjects will be enrolled in the study: 10 subjects who have had cosmetic procedures in the past and 10 subjects who have not had such procedures. for each subject, pain tolerance in three areas will be assessed: temple, midface/cheek, and abdomen. in two areas of the face (temple and midface/cheek), a small sterile needle will be inserted into the skin along with three applications of the following devices that are fda approved for use on the face: an ultrasound device (ulthera), a pulsed dye laser (vbeam), and a radiofrequency (thermage) device. additionally, the abdomen will receive three of these four devices in a randomized order: small sterile needle insertion, a pulsed dye laser (vbeam) pulse, and a radiofrequency (thermage) exposure (the ultrasound device, ulthera, will not be used on the abdomen because it is currently not fda approved for this indication). subjects will then be asked to rate their pain after each application at each individual site using a pain scale. in addition, subjects will complete a questionnaire regarding their pain experiences and other possibly related factors before and after the procedures.

Eligibility criteria:
inclusion criteria 1. subjects of both genders, 18 to 65 years of age. 2. subjects who are in good health. 3. non-naïve (patients who have not had cosmetic procedures using energy devices): subjects who have had three or more non-ablative laser procedures or any skin tightening procedure using an energy device. 4. subjects who understand and are willing to provide informed consent for participation in the study and are able to communicate with the investigator. exclusion criteria: 1. subjects who have an active skin disease or skin infection in or around the treatment. 2. subjects who are unable to understand the protocol or give informed consent. 3. subjects with photophobia or who are unable to tolerate the treatments.

Keywords: pain experience energy devices ulthera thermage vbeam
health education and relationships through theater: an rct of promoting awareness through live movement and sound for youth with autism spectrum disorder (palms-asd)

Conditions: Sexual Health; Education, Health

Summary: teens with asd ages 14-19 will be screened for eligibility, complete a baseline interviewer/acasi-administered survey, and randomly assigned to either intervention or control group. the enrollment goal is 500 teens. the 12-hour intervention will be run in groups of up to 12 teens, with health educators leading the group and actors assisting, role playing with participants, and performing a skit. teens in the intervention group will take a post satisfaction survey, and teens in both conditions will take a 6-month and 12-month interviewer/acasi-administered outcome survey. fidelity will be monitored by observers and rated by health educators.


Eligibility criteria:
inclusion criteria: * meets age limits and * parent/self-identifying as having an autism spectrum disorder, asperger's syndrome, or autism-similar social challenges, and/or * mild intellectual disability exclusion criteria: * screen-out with screening tool, if not screened in by documented staff observation * hospitalization within the last 3 months for a behavioral or mental cause * inability to participate in group setting (sensory, extreme social/communication challenges) * previous criminal conviction for sex offense * sibling previously randomized to control * screen-out with kbit-2: score \< 50 or score above 70 on kbit-2 and not receiving services for or having a diagnosis of asd * capacity to consent

Keywords: sexual health autism spectrum disorders
safety and tolerability study of ingenol mebutate compared to 5-fu to treat facial actinic keratosis

Conditions: Actinic Keratosis

Summary: background: 5% 5-fluorouracil cream (5-fu) is a well-established treatment for actinic keratosis (ak) and ingenol mebutate gel (imb) is a new topical field therapy. objective: to compare tolerability and safety of imb with 5-fu for the treatment of facial aks. methods: open-label, prospective, randomized, controlled clinical trial with 100 patients with aks within 25-cm2 contiguous field on the face. imb was applied daily for three consecutive days. 5-fu was applied twice a day for four weeks. treatment effect was evaluated at baseline and on days 2, 3, 4, 8, 15, 22, 29, 36 and 43, considering itt populations.


Eligibility criteria:
inclusion criteria: * age of at least 18 years * the presence of four to eight clinically typical, visible, and discrete aks within 25-cm2 contiguous field on the face (cheek or forehead region) * women with childbearing potential had to be using effective birth control and have a confirmed negative urine pregnancy test prior to trial treatment. exclusion criteria: * target treatment area was within 5 cm of an incompletely healed wound or within 10 cm of a suspected basal-cell or squamous-cell carcinoma * if they have received previous treatment with ingenol mebutate gel on the face or scalp (previous treatment on trunk or extremities was acceptable) * the selected treatment area had hyperkeratotic lesions or cutaneous horns and recalcitrant disease (lesions that had not responded to cryotherapy on two previous occasions) * history or evidence of skin conditions that would interfere with the evaluation of the trial medication (e.g., eczema, unstable psoriasis, xeroderma pigmentosum) * anticipated need for hospitalization or outpatient surgery during the first 15 days after the first trial medication application * known sensitivity or allergy to any of the ingredients of ingenol mebutate gel or 5-fu * presence of sunburn within of the target treatment area; current enrolment or participation in any other interventional clinical trial within 30 days of entry into this trial * women breastfeeding * recent use of medications or other treatments that could interfere with evaluation of the target area, such as topical medications (e.g. steroids, keratolytics, immunomodulators), artificial tanners, immunomodulators, cytotoxic drugs or interferon /interferon inducers, phototherapy, systemic retinoids, biologic/monoclonal antibody drugs, or other therapies for aks within eight weeks prior to the first visit of the trial.

Keywords: actinic keratosis field cancerization ingenol mebutate 5-fluorouracil tolerability safety
thyroid function and structure in klinefelter syndrome

Conditions: Klinefelter Syndrome; Thyroiditis, Autoimmune; Hypothyroidism

Summary: this is a longitudinal retrospective study for the evaluation of thyroid function and structure in patients with klinefelter syndrome compared to healthy controls and patients affected by chronic lymphocytic thyroiditis.

this is a longitudinal retrospective study for the evaluation of thyroid function and structure in patients with klinefelter syndrome compared to healthy controls and patients affected by chronic lymphocytic thyroiditis (clt). the investigators will retrospectively enroll patients with klinefelter syndrome followed at the host institution and will retrieve data with regards to peripheral hormone levels (thyroid function) and ultrasonographic appearance (thyroid structure) according to pubertal status and gonadal status. data will be compared with male age- and pubertal stage-matched euthyroid controls, as well as with male patients affected by clt. the primary outcome will be the thyroid function compared to healthy controls, by the assessment of peripheral blood tsh, free t3 (ft3) and free t4 (ft4) levels according to pubertal status (pre-pubertal, pubertal and adult subjects) as well as according to gonadal status (eugonadal subjects, hypogonadal subjects and subjects receiving testosterone replacement therapy \[trt\]). secondary outcome measures will be: thyroid function indexes (ft3/ft4 ratio, ft4/tsh ratio, tsh\*ft4 product) quantitative ultrasonographic thyroid structure parameters, comprising: thyroid volume and echogenicity index, as well as the echotexture parameters of homogeneity and entropy evaluated by gray levels co-occurrence matrices (glcm). in vitro assay of testosterone and estradiol effects on deiodinase type 2 (dio2) activity in a rat pituitary cell line.

Eligibility criteria:
inclusion criteria: * patients with a confirmed diagnosis of classic, non-mosaic 47,xxy klinefelter syndrome based on a peripheral blood 97 karyotype analysis; * availability of thyroid function test results (tsh, ft3, and ft4) and/or thyroid us imaging; * availability of concurrent clinical data. exclusion criteria: * presence of other known genetic conditions or chromosomal abnormalities; * use of levothyroxine or other drugs that are either active on the hypothalamic-pituitary-thyroid (hpt) axis or that may interfere with thyroid function tests; * history of previous surgery or radiotherapy on the thyroid or pituitary glands; * current or previous t therapy (for the pre-pubertal and pubertal groups).

Keywords: klinefelter syndrome hypothyroidism thyroiditis puberty prepuberty testosterone
vessel-sparing technique versus conventional repair of pfui: a prospective comparative study

Conditions: Traumatic Urethral Stricture, Male, Overlapping Sites

Summary: pelvic fracture is associated with urethral injury in about 10% of patients . the common site of injury is at the bulbomembranous junction and anastomotic urethroplasty with a tension free anastomosis remains the gold standard management for pelvic fracture urethral injury (pfui) . traditional reconstruction of pfui requires mobilization of the bulbar urethra to reach the prostatic apex with deep dissection of the spongiosum and detachment of the bulb from the perineal membrane at the site of the bulbomembranous urethral injury, a maneuver that requires division of the bulbar arteries . then, the distal bulb and bulbar urethra will depend on retrograde blood flow through the glans and some perforating branches of the dorsal penile artery and this is usually sufficient to maintain good vitality of the spongiosum and urethra under normal circumstances . when the distal blood supply to the urethra is compromised, either by congenital anomalies such a hypospadias, by previous surgery, or by the pre-existing pelvic fracture, the retrograde flow to the spongiosum is insufficient . in such cases, traditional anastomotic urethroplasty may result in ischemic bulbar necrosis, leading to a reconstructive failure and these patients usually fail to void soon after removal of the catheter, with subsequent retrograde urethrogram (rug) showing a long bulbar urethral defect . in 2007, jordan et al described a modification to excision and primary anastomosis (epa) in the proximal bulbar urethral strictures particularly post radical prostatectomy, which includes mobilizing and preserving the bulbar arteries with the continuity of the corpus spongiosum is maintained . gomez et al believed that vessel-sparing anastomotic urethroplasty is highly relevant in the pfui scenario as it can theoretically help to avoid ischemic failure and cold glans syndrome improving sexual arousal. consequently, they modified the standard reconstructive technique for pfui by preserving bulbar arterial inflow . so that, we decide to compare between vessel-sparing technique and conventional repair in management of pfui through a prospective study.


Eligibility criteria:
inclusion criteria: - adult male patients ≥ 18 years old with pfui exclusion criteria: * recurrent cases. • history of concomitant bladder neck injury
post-marketing surveillance of ventavis® in chinese patients with primary pulmonary hypertension (pph)

Conditions: Primary Hypertension

Summary: the purpose of this study is to demonstrate the safety and efficacy of inhaled iloprost (ventavis®) among adult chinese patients with primary pulmonary hypertension, which is in compliance with chinese sfda regulation.


Eligibility criteria:
inclusion criteria: * both male and female age 18-65 years old * the treating physician has chosen ventavis as a suitable long-term treatment for the patient * patient with primary pulmonary hypertension (i.e. ipah or fpah) and classified as nyha functional class iii * written informed/data protection consent * no prior treatment with ventavis or other active treatments for pph within 6 weeks of date of study. exclusion criteria: * known or newly identified contraindication for administration of ventavis as stated in the ventavis product package insert.

Keywords: primary pulmonary hypertension (pph)
an expanded access study to assess treprostinil palmitil inhalation powder (tpip) for participants with pulmonary arterial hypertension (pah) and pulmonary hypertension associated with interstitial lung disease (ph-ild)

Conditions: Pulmonary Arterial Hypertension; Interstitial Lung Disease

Summary: the purpose of this study is to provide continued access to tpip for participants who have successfully completed the open-label extension (ole) studies of ins1009-203 for pah or ins1009-212 for ph-ild.

participants will receive tpip 80 micrograms (μg), 160 μg, or 320 μg, inhalation single-dose capsules, orally, once daily (qd).

Eligibility criteria:
inclusion criteria * the participant is ineligible for or cannot be treated satisfactorily with alternative commercially available therapy for pah or ph-ild. * participant provides their informed consent to participate as per local requirements. * participant must have successfully completed the ole ins1009-203 or ins1009-212 studies. * based on the treating physician's judgement on participant's medical history and an evaluation of the overall risk-benefit profile, the participant will be determined to be suitable for continued tpip treatment within this program. * requests for the post-ole ins1009-203 and ins1009-212 tpip studies must originate from the investigators of ins1009-203 and ins1009-212 tpip studies, respectively. * female participants must be postmenopausal (defined as no menses for 12 months without an alternative medical cause), surgically sterile, or using highly effective contraception (failure rate \<1% per year when used consistently and correctly) from day 1 to at least 90 days after the last dose. * male participants with female partners must adhere to contraception requirements to avoid potential exposure to the embryo/fetus based on the partner's reproductive status. for partners of childbearing potential, effective contraception must be used from day 1 to at least 90 days after the last dose. exclusion criteria: * no specific exclusion criteria.