Kornimate/medical-research-clean huggingface dataset:
a phase 1 study of the safety, tolerability and pharmacokinetics of abt-126 in subjects with alzheimer's disease

Conditions: Alzheimer's Disease

Summary: this study will investigate safety, tolerability and pharmacokinetics of abt-126 in up to 20 male and female subjects, between 55 to 90 years of age with mild to moderate alzheimer's disease on stable doses of acetylcholinesterase inhibitors.

this is a double-blind, placebo-controlled, randomized, multiple-dose, parallel group, multicenter study. up to 20 male and female subjects with mild to moderate alzheimer's disease (ad) who are taking stable doses of acetylcholinesterase inhibitors will be enrolled in this study. the study will be conducted in up to four sites. within 28 days prior to study drug administration, subjects will be screened based on national institute of neurological and communicative disorders and stroke/alzheimer's disease and related disorders association (nincds/adrda) criteria for probable ad, mini-mental state examination (mmse) and modified hachinski ischemic scale (mhis) scores, medical history, physical examination, neurological examination, vital signs, ecg, laboratory tests and response to columbia-suicide severity rating scale (c-ssrs). subjects will be divided into two groups of 10 subjects each. in each group, 8 subjects will receive abt-126 and two subjects will receive matching placebo. group 1 will be administered dose 1 of abt-126 or placebo. group 2 will be administered dose 2 abt-126 or placebo. all doses will be administered once daily in the morning for 10 days.

Eligibility criteria:
inclusion criteria 1. male or female and age between 55 and 90 years, inclusive. 2. the subject meets the national institute of neurological and communicative disorders and stroke/alzheimer's disease and related disorders association (nincds/adrda) criteria for probable alzheimer's disease (ad). 3. the subject has a mini-mental state examination (mmse) total score of 16 to 26, inclusive, at screening visit. 4. the subject has a modified hachinski ischemic scale (mhis) score of ≤ 4 at screening visit. 5. the subject must be on a stable dose of donepezil or rivastigmine for at least 1 month prior to study drug administration. 6. the subject has had a computerized tomography or magnetic resonance imaging scan, interpreted by a radiologist or neurologist, within 36 months prior to randomization and after the subject met nincds/adrda diagnostic criteria for probable ad. the scan must not show evidence for an alternative etiology for dementia. exclusion criteria 1. receipt of an investigational product within 6 weeks prior to study drug administration. 2. history of significant sensitivity or allergy to any drug. 3. history of any significant neurological disease other than ad. 4. significant current suicidal ideation within 1 month prior to study drug administration as evidenced by answering "yes" to questions 4 or 5 on the suicidal ideation portion of the columbia-suicide severity rating scale (c-ssrs) completed at screening or any history of suicide attempts.
intern health study 2022 and 2023

Conditions: Depression; Mood; Sleep; Physical Activity

Summary: the aim of this trial is to evaluate the efficacy of an intervention (delivered through a smartphone) for improving the mood, physical activity, and sleep of medical interns.

due to their high stress workloads, medical interns suffer from depression at higher rates than the general population. interns also tend to have lower sleep and decreased physical activity. the goal of this trial is to evaluate the efficacy of a mobile health intervention intending to help improve the mental health of medical interns. the intervention sends mobile phone notifications which aim to help interns improve their mood, maintain physical activity, and obtain adequate sleep during their internship year. the primary aim of the study is to evaluate how notifications affect participants' weekly mood, as measured through a daily one question mood survey. the second primary aim of the study is to evaluate how notifications affect participants' long-term mental health, as measured by the patient health questionnaire. the first secondary aim is to evaluate how mood notifications affect participants' weekly mood. the second secondary aim is to evaluate how activity notifications affect participants' weekly step count. the third secondary aim is to evaluate how sleep notifications affect participants' weekly sleep duration. in order to better optimize notification delivery, the final aim (exploratory) is to understand moderators of these effects. moderators of interest are previous week's mood, previous week's step count, previous week's sleep duration, study week, sex, previous history of depression, and baseline neuroticism.

Eligibility criteria:
inclusion criteria: * medical intern during the 2022-2023 or 2023-2024 internship years * iphone or android phone user * logged into the intern health study mobile app, completed consent, and filled out baseline survey by june 30 prior to the start of intern year exclusion criteria: * none
assessment of catheter flow direction using color flow doppler in labor epidurals

Conditions: Labor Pain

Summary: epidural analgesia is commonly used for pain relief in labor and involves placement of a catheter in the epidural space. failure of epidural analgesia may occur in 12-16% of epidural catheter placements. it is defined as inadequate analgesia after the local anesthetic loading dose, despite use of appropriate dose/concentration of local anesthetic. failure to provide adequate epidural analgesia is commonly caused by malposition of the epidural catheter. many factors may influence the position of the tip of the epidural catheter and the resulting spread of local anesthetic into the epidural space, and consequently the quality of analgesia. previously, x-ray exposure was required to assess catheter position in the epidural space. recent developments have allowed the anesthesiologist to assess the catheter position at the bedside after its placement, using color flow doppler ultrasonography. the investigators will perform an observational study to determine epidural catheter flow direction in the obstetrical population using color flow doppler ultrasound. women who have delivered under epidural analgesia, either vaginal or caesarean delivery, will be approached for the study before the epidural catheter is removed. the investigators aim to determine epidural flow relative to the insertion site, describe the findings and to correlate them with other clinical outcomes.


Eligibility criteria:
inclusion criteria: * women who have delivered under epidural analgesia * women who have vaginal or caesarean delivery * women with the epidural catheter still in place exclusion criteria: -women who experience fetal or maternal complications during delivery

Keywords: epidural catheter epidural analgesia labor epidural ultrasound doppler
comparative efficacy of sciatic and femoral blocks in ankle surgery

Conditions: Postoperative Pain Management; Postoperative Pain; Analgesia; Nerve Blocks; Ankle Surgery

Summary: comparison of anesthetic and postoperative analgesic efficacy of femoral and popliteal sciatic block vs femoral and anterior sciatic block in ankle surgery

the sciatic nerve, which arises from the sacral plexus, is the largest nerve in the body. it originates in the posterior region of the thigh in the lumbosacral area and is formed from the anterior branches of spinal nerves from l4 to s3 within the pelvis. it exits the pelvis through the greater sciatic foramen directly below the piriformis and then progresses towards the posterior compartment of the thigh, where it usually divides into the common peroneal nerve and the tibial nerve at the upper corner of the popliteal fossa. sciatic nerve blocks provide both analgesia and anesthesia in surgeries below the knee, knee surgeries involving the posterior compartment, and foot and ankle surgeries. they can be used alone or in combination with an ipsilateral lumbar plexus block or femoral nerve block to provide surgical anesthesia or analgesia for the entire lower extremity. various approaches have been described to perform sciatic nerve block, including anterior and popliteal approaches. the anterior approach to the sciatic nerve can be performed as easily and successfully under ultrasound guidance as the popliteal approach. the anterior approach is advantageous when combined with a femoral nerve block, as it is performed with the patient in the supine position. due to ease of application and high success rates, peripheral blocks have begun to be incorporated into anesthesia and postoperative analgesia strategies in ankle surgeries. the use of ultrasonography plays a crucial role in increasing the success rate of the block and reducing potential complications.

Eligibility criteria:
* inclusion criteria: * 18-65 years of age * american society of anesthesiologists physical statusⅰ-ii exclusion criteria: * pregnant * neuromuscular disease * peripheral neuropathy * coagulation disorders * allergy to local anesthetics * infection at the site where the nerve block will be applied

Keywords: nerve blocks ankle surgery postoperative pain sciatic block femoral block
intensive education in increasing understanding of lymphedema in patients with breast cancer undergoing surgery

Conditions: Breast Cancer; Lymphedema

Summary: this pilot clinical trial studies intensive education in increasing understanding of lymphedema in patients with breast cancer undergoing surgery. lymphedema is the build-up of fluids in the arm (or other extremity) after surgery. providing written educational handouts and verbal education on the risk factors and symptoms of lymphedema may improve patients' ability to identify symptoms of lymphedema after surgery.

primary objectives: i. to assess the patient's increased knowledge of lymphedema signs/symptoms after education. secondary objectives: i. the participant may detect lymphedema signs/symptoms at an early stage by having a pre-surgery comparison of bilateral upper extremities (bue) circumferential measures to the 3 month post-surgery measures. outline: participants complete a five question survey, designed by the occupational therapy staff, as an instrument to assess a patient's knowledge of lymphedema signs/symptoms before surgery. an occupational therapist (ot), physical therapist (pt), and/or certified lymphedema therapist (clt) provide written handouts to participants on the pathophysiology, signs, symptoms, and treatment of lymphedema. participants repeat the survey at 3 months post-surgery. bue circumferential measurements are also collected before surgery and at 3 months post-surgery.

Eligibility criteria:
inclusion criteria: * participants will be diagnosed with breast cancer; the participants will be scheduled for a lumpectomy or a mastectomy at uh gmc seidman cancer center * they must understand written, verbal, and/or recorded survey questioning english exclusion criteria: * individuals with previous radiation treatments to the breast or axilla areas * prior diagnosis of lymphedema * persons that do not speak english * those unwilling to participate in the follow-up call 3 months post-surgery
a multicenter trial of rofecoxib and naproxen in alzheimer's disease (nsaid study)

Conditions: Alzheimer Disease

Summary: the primary specific aim of this clinical trial is to determine whether treatment with rofecoxib or naproxen for one year will slow the rate of decline of cognitive function in patients with alzheimer's disease (ad) as measured by adascog.

evidence that inflammatory mechanisms contribute to neuronal injury in alzheimer's disease along with a number of epidemiological studies suggests that non-steroidal anti-inflammatory drugs (nsaids) may slow the rate of cognitive deterioration. we have selected two such drugs for a therapeutic trial: rofecoxib and naproxen. the trial employs a double-blind parallel design with three primary treatment groups: rofecoxib, naproxen and placebo. a total of 320 patients will be enrolled in the trial and randomized to the three groups. stable use of cholinesterase inhibitors, estrogen, low dose aspirin, and vitamin e will be allowed. patients with inflammatory diseases that might respond to the study medications will be excluded. the primary outcome measure will be the one year change in the cognitive subscale of the alzheimer's disease assessment scale (adascog). the attainment of significant endpoints will be examined as a secondary outcome measure. other secondary measures include the cdr sum-of-boxes, neuropsychiatric inventory, the quality of life-ad and the adcs pharmacoeconomic scale. the influence of hla-dr (human leukocyte antigen) genotype on clinical progression and response to treatment will also be examined.

Eligibility criteria:
inclusion criteria: * nincds/adrda criteria for probable ad * mmse between 13 and 26, inclusive * stable medical condition for 3 months * screening visit * physically acceptable for this study as confirmed by medical history, physical exam, neurologic exam, and clinical laboratory tests * supervision available for administration of study medications; caregiver/informant to accompany patient to all scheduled visits * fluent in english or spanish * age greater than or equal to 55 years old * modified hachinski of less than or equal to 4 * ct or mri since onset of memory impairment demonstrating absence of clinically significant focal lesion * able to complete baseline assessments * 6 years of education or work history sufficient to exclude mental retardation * able to ingest oral medication exclusion criteria: * hypersensitivity to aspirin or nsaid * active peptic ulcer disease within 5 years * renal insufficiency with creatinine greater than 1.5 * clinically significant liver disease * poorly controlled hypertension * congestive heart failure * bleeding ulcer * active neoplastic disease (skin tumors other than melanoma are not exclusionary; patients with stable prostate cancer may be included at the discretion of the project director) * inflammatory diseases (including crystal arthropathy, rheumatoid arthritis, systemic lupus, erythematosus, sjogren's syndrome, inflammatory bowel disease)

Keywords: anti-inflammatory
clinical trial to evaluate the efficacy of treatment with hyperimmune plasma obtained from convalescent antibodies of covid-19 infection

Conditions: SARS-CoV 2

Summary: phase i / ii multicentre, randomized and controlled clinical trial to evaluate the efficacy of treatment with hyperimmune plasma obtained from convalescent antibodies of covid-19 infection.


Eligibility criteria:
inclusion criteria: 1. informed consent prior to performing procedures. the oral consent be accepted testified to prevent paper handling. 2. patient of both sexes, and ≥18 years. 3. sars-cov-2 infection determined by pcr in a sample of naso-oropharyngeal exudate or other respiratory specimen or determination of specific positive igm antibodies, in \<72 hours before randomization. 4. patients requiring hospitalization for pneumonia covid-19 without need until randomization of mechanical ventilation (invasive or non-invasive), and at least one of the following: * o2 saturation ≤ 94% in ambient air, or pao2 / fio2 ≤ 300 mm hg. * age\> 65 years. * presence of: high blood pressure, chronic heart failure, chronic obstructive pulmonary disease, liver cirrhosis, or other chronic pulmonary and cardiovascular diseases, diabetes, or obesity exclusion criteria: 1. requirement before randomization of mechanical ventilation (invasive or non-invasive). 2. any of the following analytical data before randomization: il-6\> 80 pg / ml, d-dimer\> 10 times uln, ferritin\> 1000ng / ml. 3. participation in another clinical trial or experimental treatment for covid-19. 4. in the opinion of the clinical team, progression to death or mechanical ventilation is highly probable within 24 hours, regardless of treatment provision. 5. incompatibility or allergy to the administration of human plasma. 6. severe chronic kidney disease grade 4 or requiring dialysis (ie egfr \<30) 7. pregnant, lactating, or fertile women who are not using an effective method of contraception. it is considered a woman of childbearing age all women from 18 years and up to a year after the last menstrual period in the case of menopausal women
intrathecal morphine administration using implantable pump with continuous or programmable flow

Conditions: Advanced Cancer; Intractable Pain

Summary: the aim of this study is to compare intrathecal morphine administration: using a pump with continuous or programmable flow.

cancer is frequently associated with pain. in spite of recent improvements in cancer related pain treatment, incidence of cancerous chronic pain did not decrease. indeed, 15 to 20% of patients are still suffering from intractable pain despite an optimal symptom management. treatment of cancer pain is generally based on the who analgesic ladder according to 3 steps. patients with advanced cancer are often treated at who step 3 analgesics, i.e. morphine and its derivatives, at high dosages. but increasing the dosage of opioids also leads to accentuation of their adverse events and the corresponding risks. at this stage of the disease, in patients with failure of conventional analgesic therapy, intrathecal injection of analgesics can be decided in order to relieve pain. 2 types of pumps allow intrathecal morphine administration : continuous or programmable flow. in this study, we want to compare the quality of analgesia obtained through these 2 flows.

Eligibility criteria:
inclusion criteria: * age \> or = 18 years old. * patient with advanced cancer. * patient with severe pain, i.e. a mean daily pain score \> or = 5 on an numeric rating scale. * failure of optimal conventional analgesic therapy : either due to intolerable adverse events or to lack of efficacy, i.e. after having tried opioid rotation techniques, different way of administration, use of rapid-acting narcotics to control acute episodes of pain, use of intravenous morphine by pca pump. * possibility of return home * dated and signed informed consent form. exclusion criteria: * patient's refusal to participate in the study. * ongoing pregnancy. * ongoing systemic infection. * injection site infection. * estimated survival less than 90 days. * allergy or intolerance to morphine. * contraindication to implantation of an intrathecal catheter. * patient treated with a powerful cyp1a2 inhibitor, such as fluvoxamine or enoxacin. * intrathecal chemotherapy planned.

Keywords: pain cancer intrathecal analgesia morphine implantable pump
examination of b cell responses in human blood

Conditions: HIV Infections

Summary: the aim of this study is the assessment b-cell immune responses in hiv-infected individuals.

groups of patients with different immune competencies will be examined. the impact of hiv infection on immune response will be assessed.

Eligibility criteria:
inclusion criteria: * hiv-infected individuals * controls exclusion criteria: - none

Keywords: hiv b-lymphocyte
a study to evaluate the combination of valsartan and amlodipine in hypertensive patients not controlled on monotherapy

Conditions: Hypertension

Summary: this study is designed to provide additional efficacy and safety data for a treatment strategy based on the combination valsartan with amlodipine in hypertensive patients previously treated with monotherapy and remaining uncontrolled. a naturalistic approach will be taken comparing two different doses, i.e. 160mg of valsartan with amlodipine 5mg and 10mg with possible addition of hctz


Eligibility criteria:
inclusion criteria * male or female patients ≥18 years of age * non-diabetic patients must have mssbp of ≥140 mmhg and/or msdbp ≥90 mmhg at visits 1 and 2. diabetic patients must have mssbp ≥130 mmhg and/or msdbp ≥80 mmhg at visits 1 and 2 * patients treated with monotherapy at a dose considered as adequate by the investigator for a minimum of two months prior to visit 1 exclusion criteria * known or suspected contraindications, including history of allergy to arbs, ccb, thiazides or to drugs with similar chemical structure. * mssbp ≥180 mmhg and/or msdbp ≥110 mmhg (mssbp ≥160 mmhg and/or msdbp ≥100 mmhg for diabetic patients) at any time between visit 1 and visit 2. * evidence of a secondary form of hypertension, to include coarctation of the aorta, primary hyperaldosteronism, renal artery stenosis, or pheochromocytoma. * known keith-wagener grade iii or iv hypertensive retinopathy. * other exclusion criteria apply

Keywords: hctz hypertension valsartan amlodipine
a study evaluating rocatinlimab in moderate-to-severe atopic dermatitis (rocket-ignite)

Conditions: Atopic Dermatitis

Summary: the purpose of this study is to evaluate the efficacy and safety of rocatinlimab in monotherapy treatment.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years with a diagnosis of ad according to the aad consensus criteria (2014) present for at least 12 months * history of inadequate response to tcs (topical corticosteroid) of medium to higher potency (with or without topical calcineurin inhibitors \[tci\]). * easi score ≥16 * viga-ad score ≥3 * ≥10% body surface area (bsa) of ad involvement * worst pruritus numerical rating scale ≥ 4 exclusion criteria: * treatment with a biological product within 12 weeks or 5 half-lives, whichever is longer, prior to day 1 * treatment with any of the following medications or therapies within 4 weeks or 5 half-lives, whichever is longer, prior to day 1: * systemic corticosteroids * systemic immunosuppressants * phototherapy * janus kinase inhibitors * treatment with any of the following medications or therapies within 1 week, prior to day 1: * tcs of any potency * tci * topical phosphodiesterase type 4 inhibitors * other topical immunosuppressive agents * combination topical agents including tcs of any potency, tci, pde4 inhibitors, or other topical immunosuppressive agents

Keywords: atopic dermatitis amg 451 khk4083 rocatinlimab
malaysia-singapore acute lymphoblastic leukemia 2010 study

Conditions: Acute Lymphoblastic Leukemia (ALL)

Summary: the overall objective of this study is to continue to improve the cure rate of childhood acute lymphoblastic leukemia (all) in singapore and malaysia in the context of a multi-centre cooperative trial using a risk-stratified therapy based primarily on early response to therapy utilizing a simplified minimal residual disease (mrd-lite) platform.

the study was designed on the premise that a risk classification strategy combining clinical and genetic presenting features with molecular assessment of mrd should reduce both treatment-related toxicities and relapse risk. the patient will be assigned to one of the 3 risk groups depending on his/her response to the treatment and special laboratory tests. there are no experimental drugs in this study. all the drugs used are standard established treatment for childhood all for the last 30 years. the difference in treatment is by changes in the frequency and dose of the chemotherapy drugs. the overall study treatment lasts for about 2 years.

Eligibility criteria:
inclusion criteria: 1. confirmed diagnosis of non-burkitt b-lineage all 2. 1 to 17 years of age (before 18th birthday) 3. renal function within normal range for age 4. liver function within normal range for age 5. able to participate in the full 2 years of treatment exclusion criteria: 1. age less than one year or age greater than/equals to 18 years 2. previous treatment with cytotoxic agents or high-dose steroids 3. mixed phenotype acute leukemia (mpal) 4. all as secondary malignancy 5. abnormal renal or liver function 6. doubtful compliance or unable to afford full course of therapy