Kornimate/medical-research-clean huggingface dataset:
metyrapone as additive treatment in major depression

Conditions: Major Depressive Disorder

Summary: the purpose of this study is to test whether metyrapone is an effective and safe augmenting agent in the treatment of major depression.

the investigators' understanding of the neuroendocrine pathophysiology of depression has made significant progress in recent years, which should help to develop new remedies. alterations of the hypothalamic-pituitary-adrenocortical (hpa) axis are the most consistent pathological endocrine findings in depression. hence, attempts have been made to treat depression by directly targeting hpa-axis activity. currently, three major pathways are investigated: * administration of crh-antagonists; * administration of glucocorticoid-receptor-antagonists; and * treatment with steroid-synthesis inhibitors like ketoconazole, aminogluthethimide or metyrapone. the investigators' aim was to conduct the first prospective, randomized, placebo-controlled, double-blind clinical trial of metyrapone as additive treatment in depression. metyrapone was preferred, since this compound inhibits selectively the 11β-hydroxylase and the 11β-hydroxysteroid dehydrogenase type 1 (11β-hsd-1), thereby exerting direct effects within the central nervous system (cns). the additive approach was applied because the intended inclusion of severely depressed patients made a pure placebo group ethically challenging. furthermore, the continuous use of an antidepressant allowed a standardized follow up after the double-blind period. the hypotheses to be tested were, whether metyrapone exerts potentiating effects during a standard antidepressant therapy and whether an earlier onset-of-action and an improved overall and sustained treatment response can be achieved. since gr/mr distribution as well as 11β-hsd-1 activities are subject to sexual dimorphism in humans, the sample was prospectively stratified for gender and balanced for treatment with two selected serotonergic antidepressants, allowing further analysis of gender effects and neuroendocrine treatment effects.

Eligibility criteria:
inclusion criteria: * diagnosis of major depressive disorder; single or recurrent according to dsm-iv criteria (296.2 or 296.3) * a minimum baseline hamilton score of 18 points on the hamilton rating scale for depression (hamd; 21-item version) * age from 18 to 75 years * a drug free period of at least 5 days from antidepressants, antipsychotics, mood stabilizers and all other medications except for mild antihypertensive agents * a negative urinary drug screening diagnosis exclusion criteria: * a current dsm-iv diagnosis for other axis i psychiatric disorders * serious medical conditions, especially those associated with adrenal insufficiency * pregnancy, nursing or refusal to use a reliable method of birth control in women. participants were randomly assigned to a study group if they met these criteria.

Keywords: clinical trial double-blind randomized placebo-controlled trial metyrapone major depression
study of bms-354825 in subjects with cml who are resistant to or intolerant of imatinib or ph+all in japan

Conditions: Chronic Myelogenous Leukemia

Summary: this study is composed of phase i and phase ii part. phase i part: the objective is to evaluate the safety of bms-354825 in subject with chronic phase chronic myelogenous leukemia (cml). dosage of bms-354825 will be 50 mg bid, 70 mg bid or 90 mg bid. phase ii part: the objective is to evaluate the efficacy of bms-354825. dosage will be decided according to the results of phase i part. treatment period will be 6 months for subjects with chronic phase cml, and 3 months for subjects with accelerated phase or blast phase cml and philadelphia chromosome positive acute lymphoblastic leukemia (ph+all)


Eligibility criteria:
inclusion criteria: * philadelphia chromosome positive or bcr-abl gene positive * chronic myelogenous leukemia (cml) * subjects must have primary or acquired resistance to imatinib mesylate or have intolerance of imatinib mesylate * philadelphia chromosome positive acute lymphoblastic leukemia (ph+all) * subjects must have primary or acquired resistance to chemotherapy or have intolerance of chemotherapy * performance status (general conditions) specified by the eastern cooperative oncology group: 0-2 * men and women, ages 20 - 75 * women of childbearing potential (wocbp) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 3 months after the study in such a manner that the risk of pregnancy is minimized exclusion criteria: * subjects who are eligible and willing to undergo transplantation at pre-study * women who are pregnant or breastfeeding * uncontrolled or significant cardiovascular disease * history of significant bleeding disorder unrelated to cml or all * adequate hepatic function * adequate renal function * medication that increase bleeding risk * medication that change heart rhythms * subjects who are compulsorily detained for legal reasons or treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study

Keywords: imatinib resistant or intolerant cml treatment resistant or intolerant ph+all
community-based individualized homeopathic rehabilitation in post covid-19 patients

Conditions: Post-COVID Syndrome

Summary: a growing number of studies identify a spectrum of persistent symptoms experienced by covid-19 patients for months after recovery. symptoms include cough, fatigue, dyspnea, pain, and brain fog (cognitive impairment, including confusion and memory loss), which have a negative impact on daily activities. homoeopathic practitioners from around the world have documented a number of successful cases of post covid treatment. even though evidence from practice-based research is limited, the purpose of the current study was to evaluate the effect of individualized homoeopathy treatment on post-covid syndrome.


Eligibility criteria:
inclusion criteria: * confirmed covid-19 history * persistent respiratory symptoms for more than three months after covid-19 * able to provide informed consent exclusion criteria: * presence of respiratory issues without covid-19 diagnosis * on complementary and alternative treatment * symptoms of infection * pregnancy or breastfeeding * cognitive impairment

Keywords: rehabilitation homeopathy post-covid syndrome
clinical and dermoscopic comparison of rheumatoid arthritis, ankylosing spondylitis and psoriasis patients' nails

Conditions: Psoriasis Circinata; Psoriatic Arthritis; Rheumatoid Arthritis; Spondylarthropathies; Psoriatic Nail

Summary: this study evaluates the fingernail findings of the rheumatoid arthritis, spondylopathy and psoriatic arthritis patient groups with the fingernails of psoriasis patients clinically and dermatoscopically and investigates the benefit of dermoscopy in the differentiation of these patients.

psoriasis is a common chronic inflammatory disease with many comorbidities. dermatologists have a very important role in the early diagnosis of psoriatic arthritis, which is one of the most important comorbidities of psoriasis. therefore, studies have been conducted on many factors predicting the risk of psoriatic arthritis and it has been concluded that nail involvement is closely related to psoriatic arthritis.for this reason, the importance of nail examination in the follow-up of psoriasis patients has increased significantly. nail examination should be done carefully to predict the risk of developing psoriatic arthritis, especially at the beginning of the disease and subclinical types, and dermoscopy should be used to identify patients who may be clinically uncertain. in addition, rheumatoid arthritis and spondylopathy patients have a lot in common with psoriatic arthritis patients.in these patients, there is no clear distinction to diagnose joint involvement, and their distinction is mostly based on the presence or absence of skin findings.nail findings have an important place among this skin findings in the diagnosis of these patients. based on all these, this study questions the benefit of clinical and dermoscopic examination of nail findings in the early stages to differentiate these patients, as well as comparing the nail findings and revealing the differences and similarities.

Eligibility criteria:
inclusion criteria: * psoriasis confirmed by dermatologist. * rheumatoid arthritis, ankylosing spondylitis confirmed by rheumatologist (newly diagnosed). exclusion criteria: * unable to consent and understand * patients with confirmed onychomycosis * patients receiving biological therapy

Keywords: psoriasis psoriatic arthritis psoriatic nail dermoscopy
study on single-cell regulons atlas of pancreatic ductal adenocarcinoma

Conditions: Pancreatic Ductal Adenocarcinoma (PDAC); Molecular Prognostic Model; Regulons

Summary: the first purpose of this study is to reveal the gene regulatory network of pancreatic cancer by analyzing single-cell transcriptome sequencing data and to draw a pancreatic cancer regulator map. in addition, bulk transcriptome sequencing data are combined to construct and verify the genetic prognostic model of pancreatic cancer regulators, providing clinical tools for accurate prognostic stratification and personalized treatment of pancreatic cancer patients. the second purpose of this study is to explore the molecular mechanism by which the key oncogene in the gene prognostic model promotes pancreatic cancer advance. new ideas and scientific basis are provided for finding potential molecular targets for the treatment of pancreatic cancer. thus, the investigators included a tissue microarray (tma)-based cohort of 68 pdac patient tissue samples. tma was obtained from outdo biotech (shanghai, china). the study was approved by the institutional review board, and ethics document number is yb m-05-01.


Eligibility criteria:
inclusion criteria: * pancreatic ductal adenocarcinoma * with post-operative paraffin specimens exclusion criteria: * other types of pancreatic cancer other than pancreatic ductal adenocarcinoma * without post-operative paraffin specimens or less than 20% of the paraffin sections contain cancerous tissue
phase ii study of oxaliplatin in combination with 5-fu in 1st line treatment of locally advanced or metastatic squamous cell carcinoma of the head and neck

Conditions: Head and Neck Cancer

Summary: to evaluate the efficacy of first line oxaliplatin in combination with 5-fluorouracil (5-fu) in patients with advanced inoperable or metastatic head and neck cancer and to investigate the safety profile of this regimen in the above indication and consider other criteria of efficacy (clinical benefit, survival)


Eligibility criteria:
inclusion criteria: patients aged 18-70 years, with inoperable locally advanced or metastatic squamous cell carcinoma of the head and neck (stage iii-iv) histologically proven, no prior chemo and/or hormone therapy for metastatic disease or local recurrence (adjuvant or neo-adjuvant chemotherapy or radio-chemotherapy was allowed if finished since more than 6 months before inclusion and cisplatinum total dose used \ or=to 20 mm on computed tomography (ct) or magnetic resonance imaging (mri) evaluated \ or =to 10 g/dl, neutrophils \> or =to 2000/mm3, platelets \> or =to 100,000/mm3 , creatinine \ or =to 60%. written informed consent signed by patient and doctor prior to all study procedures - exclusion criteria: -
a prospective trial of virtual home rehabilitation after burn injury

Conditions: Burns; Burn Scar; Contracture

Summary: the overarching goal for this prospective randomized controlled trial (prct) is to determine whether a virtual-environment, home-rehabilitation program improves functional outcomes for individuals after a burn injury. specifically, this study will test the efficacy of a technology-assisted rehabilitation program against current standard of home therapy.

this is a prospective, randomized controlled trial (prct) involving 50 adult burn survivors. this study tests the efficacy of a technology-assisted rehabilitation program against current standard of home therapy. there are two study groups for which subjects will be randomized: control and experimental.the control group will receive treatment as usual, which includes a personalized home exercise program prescribed by a burn therapist, prior to hospital discharge. the experimental group receives treatment as usual, in addition to training and use of the jintronix platform for 3 months after hospital discharge. participants will undergo their prescribed therapy regimen for 3 months, with outcomes follow-up to 12 months post-discharge.

Eligibility criteria:
inclusion criteria: * age greater than or equal to 18 years old (no upper age limit) * ability to provide written, informed consent for study participation * ability to read and understand english * anticipated discharge to home environment * home environment includes access to: * television (larger than 20 inches in diameter with high definition multimedia interface input (hdmi) * internet and email address * telephone (cell phone or landline) exclusion criteria: * age less than 18 years * inability to provide written, informed consent for study participation * inability to read or understand english * delirium (as determined by the delirium observation score test) * near-fall event at time of screening * pregnant women * discharge to non-home environment (e.g., shelter, street, skilled nursing facility)

Keywords: exercise therapy rehabilitation home
safety of herpes zoster subunit (hz/su) vaccine during pregnancy in adult women with immunocompromised conditions

Conditions: Herpes Zoster

Summary: the purpose of this postmarketing commitment safety study is to evaluate the real-world safety of hz/su vaccine during pregnancy in immunodeficient or immunosuppressed adult pregnant women between 18 and 49 years of age in the united states. the primary outcome of interest is major congenital malformations (mcms).


Eligibility criteria:
inclusion criteria: * participant who is pregnant with a pregnancy start date between july 1, 2021 and june 30, 2026. live births are to be followed for 1 year. * participant is a female aged 18-49 years on the pregnancy start date. * participant meets study definition of systemic lupus erythematosus (sle), multiple sclerosis (ms), rheumatoid arthritis (ra), inflammatory bowel disease (ibd), psoriasis (pso)/psoriatic arthritis (psa), solid organ transplant (sot), stem cell transplant (sct), hematologic malignancies (hm), solid tumors (st), or human immunodeficiency virus (hiv). codes for immunocompromised (ic) conditions will be identified in the health plan claims of the distributed research network (drn) during the period 273 days prior to the pregnancy start date through the first trimester (98 days after the pregnancy start date). diagnoses recorded through the first trimester will be included to account for women who may not have frequent visits prior to pregnancy and may have a more complete assessment of medical conditions during the first prenatal care visit. * participant has at least 273 days of continuous health plan enrollment with medical and drug benefits prior to the start of pregnancy through the delivery date, with gaps of up to 45 days in coverage being permitted. the 273-day pre-pregnancy period through the first trimester (a period of 98 days after the pregnancy start date) was chosen to allow identification of potential confounders of interest. in sentinel projects, gaps of 45 days or less in health plan enrolment are typically considered administrative gaps (and not lapses in health plan coverage) and ignored. exclusion criteria: * participant was exposed to a medication(s) that presents a known increased risk for fetal malformations. * participant delivered an infant identified as having a chromosomal or genetic anomaly. * ectopic pregnancies, molar pregnancies or induced abortions. * multigestation (e.g., twin) pregnancies.

Keywords: herpes zoster recombinant zoster vaccine targeted safety study post-authorization safety study pregnant women
wise aric: retinal photography in women with chest pain

Conditions: Chest Pain

Summary: the purposes of this study are: * to correlate the severity of retinal arteriolar narrowing and other microvascular changes, as determined from retinal photographs and video imaging, to measures of coronary microvascular function in women evaluated for chest pain. * to evaluate measures of vascular compliance with applanation tonometry and photoplethysmography using a nasal alar probe.

women who meet study eligibility criteria and provide written informed consent will have a baseline physical exam, including measurements of heart rate, blood pressure, weight. medical history will be updated, specifically cardiovascular events (hospitalizations, procedures) since last contact and current medications. patients will be scheduled for retinal photography. those who are currently being screened and qualify for ewise or other ancillary studies will have retinal photography scheduled as close to the index cfr as possible and prior to receiving randomized therapy. the retinal photography will follow a standardized written protocol. for the second protocol, 100 patients will be scheduled for an appointment in the eye clinic where they will meet the women's ischemic syndrome evaluation (wise)/atherosclerosis risk in communities (aric) staff and complete the baseline information and have a brief physical examination. they will then have provocative testing completed with retinal imaging.

Eligibility criteria:
inclusion criteria: * women who participated in or are being screened for the wise or ewise or any ancillary studies * willing to provide written informed consent * have recorded measurements of coronary flow reserve, with or without obstructive coronary disease exclusion criteria: * unwilling to complete study required procedures * contraindication to adenosine

Keywords: women chest pain microvascular dysfunction retinal photography retinal vascular function
dose-ranging study of tranexamic acid in valve surgery

Conditions: Hemorrhage; Valvular Heart Surgery

Summary: cardiac surgical procedures account for a large amount of allogeneic transfusion. tranexamic acid (ta), a synthetic antifibrinolytic drug, has been shown to reduce blood loss and transfusion requirements in cardiac surgery with cardiopulmonary bypass. there are currently multiple dosing regimens for ta in cardiac surgery. preliminary dose-response study has shown that low dose of ta would be as hemostatic efficacy as higher dose. currently, no randomized study focus on ta in primary valve surgery. the aim of this prospective, double-blinded, randomized trial is to compare two dosing regimens of ta during primary valve surgery on perioperative blood loss and allogeneic blood transfusion.


Eligibility criteria:
inclusion criteria: * valvular disease patients requiring valvular replacement or repair surgery with cardiopulmonary bypass (cpb) exclusion criteria: * a history of bleeding disorders * active chronic hepatitis or cirrhosis * chronic renal insufficiency (serum creatinine \> 2 mg/dl) * preoperative anemia (hb \< 10 g/dl) * previous cardiac surgery * urgent and emergency surgery
radiofrequency ablation for aldosterone-producting adenoma in patients with primary aldosteronism

Conditions: Primary Aldosteronism; Adrenal Adenoma

Summary: the aim of the study is to evaluate the novel use of adrenal radiofrequency ablation on a prospective cohort of patients with primary aldosteronism and unilateral adrenal adenoma concerning the efficacy on blood pressure control. the safety of the procedure is one of the secondary outcomes.

the prevalence of hypertension dramatically increased. although most cases of hypertension are idiopathic, some cases have an identifiable cause. primary aldosteronism (pa) is the most common cause of secondary hypertension and can be cured by surgery if pa is due to unilateral unique adrenal adenoma. then this cause is worth identifying it. the surgery despite its minimally invasive nature is limited by the need for general anesthesia, the risk of vascular or visceral injuries, hematomas and all the adrenal gland is mostly removed. imaged-guided percutaneous adrenal radiofrequency ablation (arf) offers a less invasive alternative therapeutic option. this local therapy is employed to treat solid neoplasms whereas its application on functional adrenal adenoma is less documented and only a few case series with limited sample size are published. the impact on blood pressure control is not clearly reported. arf ablation works by delivering a high-frequency alternating current through a needle electrode. an ionic agitation occurs and generates frictional heat for cell destruction at a predictable temperature and volume. patients with a conventional documented pa due to unilateral adrenal nod who consented to the study were hospitalized. patients with pa due to an aldosterone-producing adenoma are included in the study.

Eligibility criteria:
inclusion criteria: * hypertension confirmed with ambulatory blood pressure monitoring * primary aldosteronism demonstrated by hormonal assays: active renin (pg/ml) or plasma renin activity (ng/ml/h) and plasma aldosterone measured twice at baseline after an overnight fast, in sitting or recumbent position * selective adrenal venous sampling after 40 years of age * unilateral adrenal nod on ct scan \<4cm * adrenal radiofrequency ablation procedure of judged technically possible by radiologists exclusion criteria: * bilateral adrenal nods * primary aldosteronism due to bilateral adrenal hyperplasia or macronodular hyperplasia * lack of documented primary aldosteronism * maximum tumor diameter greater than 4 cm * cushing syndrome or pheochromocytoma * when adrenal venous sampling is refused by the patient * coagulopathy * pregnant women * patient with potentially inaccessible nodule
normothermic machine perfusion: an additional value for kidney transplant outcomes?

Conditions: Kidney Transplant Failure; Chronic Kidney Failure

Summary: this study is a randomised, controlled, phase ii trial to assess the efficacy of 2 hours normothermic machine perfusion (nmp) of extended criteria(ec)-dbd (donation after brain death) and dcd (donation after circulatory death) donor kidneys compared to standard care, which is hypothermic machine perfusion (hmp) only in the netherlands.


Eligibility criteria:
inclusion criteria: * kidney-only transplant * renal replacement therapy at time of transplant * receiving standard immunosuppression regimen post-transplant. * donation after circulatory death (dcd) maastricht type iii, iv, or v or extended criteria donation after brain death (dbd) donor kidneys. exclusion criteria: * pre-emptive at time of transplant * receive a multi-organ or dual kidney transplant * age donor or recipient below 18 years * maastricht type i and ii dcd * donor kidneys preserved on static cold storage (scs) * kidneys retrieved after normothermic regional perfusion (nrp) * recipient virtual panel reactive antibodies ≥85% * recipient for who it is agreed in advance that dialysis after transplant is required, such as in the context of hyperoxaluria

Keywords: normothermic kidney machine perfusion