Kornimate/medical-research-clean huggingface dataset:
restore trial: a pilot rct of enhanced skills training in affective and interpersonal regulation (estair) for veterans with cptsd

Conditions: Complex Post-Traumatic Stress Disorder

Summary: complex post traumatic stress disorder (cptsd) is now recognized as a separate trauma-based psychological condition to ptsd. cptsd is a broader diagnosis that includes the core ptsd symptoms (re-experiencing in the here and now, avoidance, and sense of current threat) plus an additional set of symptoms that are collectively referred to as 'disturbances in self-organisation' (dso). dso symptoms capture pervasive psychological disturbances that are associated with traumatic exposures and that are distributed across three clusters: difficulties in affect regulation (ar), negative self-concept (nsc), and disturbances in relationships (dr). there are no effective interventions for cptsd. it is therefore of paramount important to identify effective interventions to treat veterans with cptsd. the present study will be one of the first to investigate the effectiveness of a novel, modular intervention for cptsd. enhanced skills training in affective and interpersonal regulation (estair) is a person-centered intervention that involves targeting the symptoms of cptsd clusters sequentially using concrete modules (i.e., specific number of sessions targeting specific clusters of symptoms). the overall aim of this study is to establish the feasibility, acceptability and preliminary effects of estair in treating cptsd. to achieve these aims, the investigators will conduct a pilot randomised controlled trial (rct), with a sample of 60 military veterans meeting the diagnostic criteria for cptsd, and with two treatment arms: estair vs. a treatment-as-usual (tau) condition.


Eligibility criteria:
inclusion criteria: * adults (18 years or older) in the caseload of combat stress * armed forces veteran (united kingdom) * help-seeking for trauma-related psychological distress * meeting diagnostic criteria for cptsd, as measured by the itq (cloitre et al., 2018) * proficiency in english language * signed informed consent provided exclusion criteria: * severe psychotic disorder (defined by previous clinical diagnosis) * current alcohol or drug use disorder * serious cognitive impairment * planned concurrent additional treatment

Keywords: cptsd estair modular therapy
a double-blind, placebo-controlled study with open-label follow-up to determine the safety and efficacy of r-huepo in aids patients with anemia induced by their disease and azt therapy

Conditions: HIV Infections; Cytopenias

Summary: to determine the safety and efficacy of erythropoietin (r-huepo) administered to aids patients with anemia secondary to their disease and/or concomitant zidovudine (azt) therapy.


Eligibility criteria:
exclusion criteria co-existing condition: patients with the following are excluded: * history of any primary hematologic disease. * clinically significant disease / dysfunction of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying aids. * aids-related dementia. * uncontrolled hypertension (diastolic blood pressure \> 100 mmhg). * presence of concomitant iron deficiency. * anemia attributable to factors other than aids or zidovudine (azt) therapy. * acute opportunistic infection. * history of seizures. patients with clinically significant disease / dysfunction of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying aids are excluded. prior medication: excluded within 30 days of study entry: * experimental drug or experimental device. * cytotoxic chemotherapy. * excluded within 2 months of study entry: * androgen therapy. clinical diagnosis of aids and related anemia. * clinical diagnosis of aids. * clinically stable for 1 month preceding study entry. substance abuse.

Keywords: recombinant proteins erythropoietin acquired immunodeficiency syndrome anemia zidovudine
dose-confirmatory bridging study in total knee replacement

Conditions: Venous Thromboembolism

Summary: the objective of this dose-confirmatory bridging study is to investigate the safety and efficacy of rivaroxaban 5 to 10 mg once-daily (od) dosing in the prevention of venous thromboembolism (vte) in japanese patients undergoing elective total knee replacement (tkr) and to confirm the extrapolability of global data to japanese patients by comparing with data from overseas phase iii study (record 3 - study 11356) and phase ii studies.


Eligibility criteria:
inclusion criteria: * male and female patients aged 20 years or above * patients undergoing elective tkr (the first replacement of the applicable knee joint) * patients' written informed consent to participation after receiving detailed verbal and written information on any study specific procedures in advance exclusion criteria: * planned, staged major orthopedic surgery within 3 months prior to elective tkr or during this study * history of clinically significant active bleeding (e.g. intracranial bleeding, gastrointestinal bleeding\*), or high bleeding risk \*: within 3 months prior to elective tkr for gastrointestinal bleeding * subjects with hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk * severe impaired renal function (clcr calculated by cockcroft-gault formula: \<30 ml/min) * conditions prohibiting bilateral venography (e.g. amputation of 1 leg, allergy to contrast media) * ongoing anticoagulant therapy (e.g. warfarin, heparins and factor xa inhibitors other than study medication) that cannot be stopped (in the opinion of the investigator/sub investigator) * subjects for whom epidural catheters are expected to be left in for longer than 18 hours post-operatively * planned intermittent pneumatic compression during treatment period.

Keywords: venous thromboembolism prevention orthopaedic surgery
effect of methylphenidate on connectivity

Conditions: Attention Deficit Hyperactivity Disorder

Summary: the goal of the study is to use graph theory to examine how the organization of the functional brain network may be altered by the administration of methylphenidate. this effect is to be compared between methylphenidate intake and placebo intake, as well as between healthy adult males and adult males with a diagnosis of attention deficit hyperactivity disorder.


Eligibility criteria:
inclusion criteria: * male sex * written informed consent * for the attention deficit hyperactivity disorder group only: a diagnosis of attention deficit hyperactivity disorder exclusion criteria: * age under 18 or \> 40 * previous or current medical, psychiatric, or neurological problems (with exception of attention deficit hyperactivity disorder group) * use of psychotropic medication * use of recreational drugs in the two weeks before start of the study * consuming an equivalent of \> 5 cups of coffee per day * consuming three or more alcohol units per day * the presence of one or more of the contraindications or warnings against the study drug as listed in the summary of product characteristic * presence of any contraindication to magnetic resonance imaging scanning (e.g. implanted metallic object or electronic device)

Keywords: attention deficit hyperactivity disorder healthy adults methylphenidate functional connectivity functional magnetic resonance imaging
therapeutic efficacy of intense pulsed light in the treatment of chalazion

Conditions: Chalazion

Summary: study method: this test screened the subjects first, and proposed to include 50 subjects with primary or recurrent eyelid plate gland cysts without obvious surgical indications. all subjects underwent three strong pulsed light therapy combined with eyelid plate gland massage, treatment of local anesthesia eye drops, and metal pads were placed in conjunctival sac protection. eye protection, using the m22 strong pulsed light small optical treatment head of the medical company, energy selection 14-16j/cm2, laser position is selected on the upper and lower eyelids, 3mm away from the root of the eyelashes. each interval is 3 weeks. eye-related examinations were performed before treatment and 3 times after treatment. the evaluation content included: ocular surface, slit lamp observation, anterior segment photography, intraocular pressure, vision, corneal fluorescein staining, tear film rupture time, eyelid plate gland evaluation, eyelid plate gland cyst relief, eyelid plate gland cyst recurrence rate.


Eligibility criteria:
inclusion criteria: * patients had primary or recurrent eyelid plate gland cyst without obvious surgical indications exclusion criteria: * (1) any intraocular inflammation, ocular infection, allergy, ocular surgery, or ocular trauma in the past 6 months; (2) any eyelid diseases or structural abnormality; (3) any systematic diseases may lead to dry eye or mgd; (4) skin cancer or pigmented lesion in the treatment zone.
3 month finasteride challenge test can significantly improve the performance of screening for prostate cancer

Conditions: Prostate Cancer

Summary: the investigators will propose a novel method to improve prostate cancer screening with psa, using a 3-month treatment with finasteride, a drug used to treat benign prostatic hyperplasia (bph) and proven to reduce a man's risk of developing prostate cancer. the investigators will also examine three additional promising tests that may further improve diagnosis of prostate cancer.

the primary goal of this proposal is to determine if a 5-alpha reductase 'challenge' improves screening performance of psa and dre in men who are scheduled for prostate biopsy. currently a higher psa level leads to a recommendation for prostate biopsy, causing hundreds of thousands of unnecessary biopsies annually in the u.s. we will show that a three-month treatment with finasteride for men with high psa levels will better predict the man who should have a prostate biopsy. psa performance after finasteride 'challenge' will also be compared with new tests for prostate cancer. finasteride is supplied by merck and company, incorporated.

Eligibility criteria:
inclusion criteria: 1. risk of prostate cancer 20-60% calculated with the on-line prostate cancer prevention trial (pcpt) prostate cancer risk calculator. (www.prostate-cancer-risk-calculator.com). psa value must be obtained within 3 months prior to study entry. a description of the frequency of these individuals in the population is provided in specific aim 2 2. patient has been recommended to undergo and plans to have a prostate biopsy. 3. patient is willing to delay prostate biopsy for a 3-month finasteride vs placebo treatment. 4. no allergy to finasteride or other five alpha reductase inhibitors. 5. patient is willing to take finasteride vs placebo 5 mg orally daily for 3-month treatment period. 6. age 55 or older. (this age is selected as the pcpt risk calculator is only valid for this age range.) exclusion criteria: 1. risk of cancer greater than 60% or less than 20%. 2. prior history of prostate cancer. 3. prior treatment with finasteride or dutasteride in the past 6 months 4. younger than age 55.

Keywords: finasteride placebo prostate cancer prostate specific antigen (psa) men at intermediate risk of prostate cancer men scheduled for prostate biopsy
decitabine in combination with low-dose cytarabine in elderly patients with acute myeloid leukemia

Conditions: Acute Myeloid Leukemia, Adult

Summary: this prospective multicenter clinical study was designed to assess the efficacy and safety of decitabine in combination with low-dose cytarabine induction treatment for elderly patients with newly diagnosed acute myeloid leukemia (aml).

all patients were treated with decitabine of 15 mg/ m2 intravenously over 4h for 5 consecutive days (day 1-5) for priming combined with cytarabine of 10 mg/m2 q12h for 10 days (day 4-13). hydroxyurea was permitted as rescue medication if white blood count (wbc) was \>20×109/l and but was discontinued at least 24h before decitabine treatment. supportive care including blood product transfusions, g-csf, antiemetic medications, antiviral and antifungal medications, or empiric antibiotics may be used at the clinical discretion of the investigator. curative effect was evaluated after two cycles: 1. \<5% blast in the marrow, enter into maintenance therapy (group a) 2. ≥5% blast in the marrow, continue induction therapy two cycles, ① \<5% blast in the marrow, enter into maintenance therapy (group b); ② ≥5% blast in the marrow, dropped out of the study (group c) 3. marrow blast decline \<60%, dropped out of the study (group c). maintenance therapy regimen: 1. ara-c 1g/m2/d iv drip d1-4 1 cycle 2. dec 15mg/m2/d iv drip d1-5 1 cycle 3. ara-c 1g/m2/d iv drip d1-4 1 cycle 4. dec 15mg/m2/d iv drip d1-5 1 cycle

Eligibility criteria:
inclusion criteria: 1. patients with previously untreated non-m3 aml (diagnosed by the who2016 criteria). 2. age: ≥ 60 and ≤ 75 years. 3. eastern cooperative oncology group (ecog) performance status 0-2. 4. aspartate aminotransferase (ast) and alanine aminotransferase (alt)≤2.5x upper limit of normal (uln), total bilirubin ≤ 1.5 uln, serum creatinine \< 2uln. 5. without central nervous system symptoms. 6. willing to accept the follow-up. 7. normal heart function(ef\>50%). the subjects volunteer to sign the informed consent. exclusion criteria: 1. with severe cardiac, renal or hepatic insufficiency. 2. with other cancers requiring treatment. 3. with other hematological diseases(e.g. hemophilia, myelofibrosis, etc.). 4. with severe infection or metabolic disease(including tuberculosis and pulmonary aspergillosis). 5. brain disorders or severe mental diseases which could limit compliance with study requirements. 6. major operation within 3 weeks. 7. with hiv infection or aids-associated diseases. 8. any drug abuse, medical, mental or social situations which would affect the results. 9. hypersensitivity to cytarabine (not including drug fever or exanthema) or decitabine.
safety study of dantrolene in subarachnoid hemorrhage

Conditions: Subarachnoid Hemorrhage; Cerebral Vasospasm

Summary: subarachnoid hemorrhage (sah) is a devastating acute brain injury due to bleeding onto the brain surface from a ruptured aneurysm. cerebral vasospasm (cvsp; critical narrowing of brain arteries) is a known complication after sah and significantly increases disability and death after sah. vasospasm is difficult to treat and can lead to stroke. animal studies have shown that the muscles in the artery wall play a role in cvsp. dantrolene has been fda approved and extensively used in clinical practice as a muscle relaxant for more than 30 years. it has been shown to provide some benefit in animal studies of cvsp, as well as in a small number of humans. however, the first human studies have only been observational and over a short period of time. this study will evaluate the safety and tolerability of intravenous dantrolene given every 6 hours over seven days to patients with or at risk for cvsp after sah. the goal is to determine if future efficacy studies should be done to determine if treatment with dantrolene may improve the outcome of patients with cvsp after sah.

once eligibility criteria are met, patients will be randomized to either dantrolene-iv or placebo (equiosmolar, volume-equivalent sterile water with 5% mannitol as dantrolene-iv also contains 5% mannitol). study subjects will be visited daily by a study nurse to determine side effects, tolerability, record hemodynamic measures and laboratory values. patients will have daily serum na, osmolality, aspartate aminotransferase (ast), alanine aminotransferase (alt) and alkaline phosphatase (alk) measured. in addition, daily bedside transcranial doppler will be performed by a blinded examiner. patients will undergo cerebral angiograms per clinical routine. angiographic measurements of arterial narrowing will be performed by a blinded radiologist. specific stop criteria are pre-defined.

Eligibility criteria:
inclusion criteria: * documented aneurysmal sah by computed tomography angiography (cta), magnetic resonance angiography (mra) or angiography * secured aneurysm (coiled or clipped) * enrollment achievable within 14 days after sah exclusion criteria: * pregnancy * prior history of cirrhosis or hepatitis b/c, or any two of the following three liver enzymes elevated to greater than: alt \>120 units/l, ast \>120 units/l, alkaline phosphatase \>345 units/l (three times upper limit of normal) * patients on verapamil * patients with brain edema and/or elevated intracranial pressure (\>25mm hg) * patients treated with hypertonic saline or mannitol prior to enrollment * patients with too severe sah with low likelihood of survival (hunt \& hess 5)
a study to evaluate the safety and efficacy of subcutaneously administered regn475(sar164877) in patients with sciatic pain

Conditions: Sciatica

Summary: this is a phase 2, randomized, double-blind, parallel-group, single dose study to evaluate the safety and efficacy of 2 dose levels of regn475 compared with placebo in patients with sciatic pain. enrollment of approximately 50 patients in each of the 3 treatment arms is expected at up to 35 us sites, for a total enrollment of approximately 150 patients. patients will receive 1 injection under the skin of either active or placebo regn475, and be followed over 10 visits for 12 weeks.


Eligibility criteria:
inclusion criteria: 1. pain present for at least 2 weeks, but not lasting for more than 16 weeks prior to the screening visit. 2. a confirmed diagnosis of sciatica at the screening visit. 3. weight less than 120 kg exclusion criteria: 1. back surgery within 6 months prior to the screening visit 2. neurological deficit (muscle weakness and/or reflex loss; loss of bowel or bladder function) from any cause including sciatica 3. other conditions which may confound the interpretation of the study, such as carpal tunnel syndrome, ms, rheumatoid arthritis, spinal stenosis, etc. 4. allergy to doxycycline or related compounds 5. women who are pregnant or nursing

Keywords: sciatica sciatic pain pain back pain
an expanded access open-label, compassionate use protocol of remune in hiv-1-infected adults with cd4 count less than 300 cells/ml

Conditions: HIV Infections

Summary: to provide product through an expanded access program to hiv-infected patients with cd4 counts less than 300 cells/ml.


Eligibility criteria:
inclusion criteria patients must have: * hiv-1 seropositivity. * cd4 counts \< 300 cells/ml. note: * if a patient's cd4 count is 275 to 300 cells/ml, the patient must either rescreen for study 806 or wait 6 months before entering the expanded access program. * patient must have failed or been intolerant to other comparable or alternative marketed therapies or must not be a candidate for such therapies. * patient must not meet inclusion criteria for other remune trials. * patient must have laboratory tests within specified limits. exclusion criteria co-existing condition: patients with the following symptoms and conditions are excluded: * clinically significant cardiac, hepatic, renal, or gastrointestinal dysfunction. * current participation in a remune study. concurrent medication: excluded: * use of any immune-modulating drugs. * induction therapy or initiation of new treatment regimen for an aids-defining condition. patients with any of the following prior conditions are excluded: previous participation in a remune study. prior medication: excluded: * use of any immune-modulating drugs within 3 months of day 1 visit. * induction therapy or initiation of new treatment regimen for an aids-defining condition within 30 days of day 1 visit.

Keywords: acquired immunodeficiency syndrome aids vaccines cd4 lymphocyte count salk hiv immunogen
anti covid 19 hyperimmune intravenous immunoglobulin (c-ivig) therapy for severe covid-19 patients

Conditions: Covid19

Summary: severe ill patients will be enrolled in the study (n=310) after duly filled consent forms. recipients will be divided into 2 group, each group contain 155 patients to compare safety and efficacy of patients in clinical trial phase ii/iii. one group will receive 0.15g/kg single dose of anti covid 19 intravenously immunoglobulin (c-ivig) develop from convalescent plasma of recovered patients from covid 19, along with standard of care. the comparator group will only receive standard of care

the research team at dow university of health sciences has purified immunoglobulin (both sars-cov 2 antibodies and existing antibodies) from convalescent plasma of covid19 individuals and pooled it to prepare ivig formulation to treat severe and critically ill covid-19 patients. phase i/ii trial was completed and showed potential safety and efficacy of the drug anti covid-19 intravenous immunoglobulin (c-ivig) in severe and critical patients with covid-19. this trial's aim is to investigate the safety and efficacy of passive immunization in severe covid-19 patients in phase ii/iii. the trial will be a randomized, single-blinded, superiority trial, through parallel-group design. the participant will either receive c-ivig with standard of care or receive only standard of care. the study will consist of 310 participants of which 155 will receive a single dose of c-ivig (0.15g/kg) with the standard of care and 155 will receive only the standard of care. standard of care is standard hospital care which includes airway support, anti-viral medication, antibiotics, fluid resuscitation, hemodynamic support, steroids, painkillers, and antipyretics. randomized test patients will receive a single dose of c-ivig in the following two dosage groups: group 1 (test): severe covid-19 patients: single dose of 0.15g/kg with standard hospital care group 2 (comparator): severe covid-19 patients: only standard hospital care only

Eligibility criteria:
inclusion criteria: 1. above 18 years of age 2. have positive covid pcr on nasopharyngeal and/or oropharyngeal swabs 3. classified as severe\* covid-19 according to who guideline (5l-15l of oxygen requirement on fm, nrm) 4. consent given by the patient or first degree relative exclusion criteria: 1. critical covid-19 patients \[ non-invasive ventilation (hfnc, bipap, cpap) and invasive ventilation\], 2. pregnant females 3. previous allergic reaction to immunoglobulin treatment 4. known case of any autoimmune disorder 5. chronic kidney disease 6. known case of thromboembolic disorder 7. aseptic meningitis

Keywords: covid19 (corona virus disease-2019) sars-cov-2 (severe acute respiratory syndrome coronavirus 2) passive immunization intravenous immunoglobulin (ivig) pooled convalescent plasma severe ill covid-19 patients antibody anti covid 19 antibodies anti sars cov 2 antibodies