Kornimate/medical-research-clean huggingface dataset:
tdcs and metacognitive strategy training in stroke

Conditions: Chronic Stroke

Summary: specific aim 1: complete pilot testing of study protocol in individuals with chronic stroke for feasibility evaluation and protocol refinement. specific aim 2: estimate the preliminary effect of co-op+tdcs on activity performance in individuals with chronic stroke.

a number of daily life activities are discontinued after stroke. these discontinued activities typically include basic self-care, instrumental activities of daily living, leisure, and work. these changes in participation contribute to decreased quality of life and life satisfaction. the cognitive orientation to daily occupational performance (co-op) approach is a behavioral problem-solving intervention that focuses on teaching clients how to apply cognitive strategies to enhance learning and overcome activity performance barriers. co-op uses meaningful, client-chosen activities to drive new skill learning and neural reorganization. consistent with these principles of neuroplasticity, transcranial direct current stimulation (tdcs) is a non-invasive brain stimulation method of modulating cortical excitability through application of low currents to targeted regions on the scalp. there are known positive effects of co-op to improve activity performance and for tdcs to improve impairment level outcomes post-stroke. the investigators hypothesize that the known effects of co-op may be amplified with use of tdcs to alter known neural hubs of executive networks that support problem-solving. in sum, (1) co-op is effective at improving activity performance, and (2) the effects of co-op may be amplified through novel methods that allow for placing the brain in an enhanced neuroplastic state, such as tdcs.

Eligibility criteria:
inclusion criteria: * \>6 months post-ischemic stroke * not currently receiving therapy services * a minimum of four self-identified functional goals exclusion criteria: * severe depressive symptoms (\>20 on patient health questionnaire) * dementia symptoms (\<24 on montreal cognitive assessment) * any additional neurological disorders * moderate-severe aphasia (nih stroke scale aphasia scale of greater than or equal to 2) * any tdcs contraindication

Keywords: stroke metacognitive strategy training brain stimulation co-op tdcs
β-thalassemia treatment with kl003 cell injection

Conditions: Transfusion-dependent Beta-Thalassemia

Summary: this is a non-randomized, open label, single-dose study in up to 41 participants with β-thalassemia major. the goal of this clinical trial is to evaluate the safety and efficacy of kl003 cell injection in subjects with β-thalassemia major.

this is a single-arm, multi-site, single-dose, phase 1/2 study to assess kl003 cell injection in up to 41 participants with transfusion-dependent β-thalassemia (tdt) who are ≥3 and ≤35 years of age. kl003 cell injection is autologous cd34+ stem cells transduced ex vivo with a lentiviral vector encoding βa-t87q-globin.

Eligibility criteria:
inclusion criteria: * male or female age between 3-35 years; * diagnosis of transfusion-dependent β-thalassemia and a history of at least 100 ml/kg/year of prbcs or ≥8 transfusions of prbcs per year for the prior 2 years; * karnofsky performance status ≥70 for participants≥16 years of age; lansky performance status of ≥70 for participants\<16 years of age; * eligible to undergo auto-hsct; * willing and able to follow the research procedures and conditions, with good compliance; * willing to receive at least the 2 years follow-up; * participant and/or legal guardians voluntarily participated in this clinical trial and signed the informed consent form. exclusion criteria: * diagnosis of composite α thalassemia; * prior receipt of gene therapy or allo-hsct; * meet the criteria for allo-hsct and with an identified willing donor with full hla match; * participants with severe iron overload at the time of screening; * presence of unusual antibody of red blood cell antigens or tested positive for platelet antibody; * known allergy to clinical trial drug (plerixafor or g-csf or busulfan) or ingredient(dmso etc.); * clinically significant and active bacterial, viral, fungal, or parasitic infection as determined by the clinical investigator; * subjects positive with the following etiological tests: human immunodeficiency virus(hiv-1-2),human cytomegalovirus (hcmv-dna),eb virus（ebv-dna）,hbv (hbsag/hbv-dna positive),hcv antibody (hcv-ab), human t-lymphotropic virus antibody (htlv-ab), treponema pallidum antibody (tp-ab); * uncorrectable coagulation dysfunction or history of severe bleeding disorder; * history of major organ damage including: 1. liver function test suggest ast or alt levels \>3× upper limit of normal（uln）; 2. total serum bilirubin value\>2.5×uln;if combined with gilbert syndrome, total bilirubin\>3×uln and direct bilirubin value\>2.5×uln; 3. left ventricular ejection fraction \<45%; 4. baseline calculated egfr\<60ml/min/1.73m2; 5. pulmonary function:fev1/fvc\<60% and/or diffusion capacity of carbon monoxide (dlco) \<60% of prediction;

Keywords: gene therapy lentiviral vector kl003 cell injection transfusion-dependent β-thalassemia
sleep therapy for insomnia and depression

Conditions: Depression; Insomnia

Summary: in this study we are testing 2 different forms of sleep therapy to help people with insomnia and depression. as part of the study, you receive 1 of these 2 sleep therapies. we want to see how these sleep therapies help insomnia in people with depression.

the first group is the sleep hygiene group. if you are assigned to the sleep hygiene group you have 1 session with a clinician to learn about different things you can do to improve your sleep. the second group is the intensive sleep retraining group. if you are in this group you will spend about 1 day at our sleep lab, starting around your usual bedtime and ending the following day. over a 20 hour period you will complete a sleep retraining session, which involves an opportunity to fall asleep every 30 minutes; we will wake you after a few minutes if you fall asleep. for both groups, after the treatment session, you will complete questionnaires online and talk with a study clinician who will ask you questions about your mood every two weeks for 8 weeks.

Eligibility criteria:
inclusion criteria: * experiencing depression * experiencing chronic insomnia * have been taking an antidepressant medication at a stable dose for at least 8 weeks, and willing to stay on a stable dose for the duration of the study. this medication must be prescribed by a doctor at the university of michigan. or not taking any antidepressants and you do not plan to start taking any antidepressants over the next 9 weeks. exclusion criteria: * have psychiatric conditions or sleep disorders other than depression or insomnia * have a chronic medical condition that could negatively affect your sleep or mood * are currently receiving treatment for insomnia (such as prescription or over-the-counter medications, or other therapies)
phase 3 study to evaluate the efficacy and safety of droxidopa on orthostatic hypotension treatment in hemodialysis patients

Conditions: Orthostatic Hypotension

Summary: orthostatic hypotension is a major complication of hemodialysis and interferes with everyday activities in hemodialysis patients. since information regarding the use of droxidopa in clinical trials relating to orthostatic hypotension of chronic hemodialysis patients is limited in taiwan, this study is designed for evaluation the efficacy and safety profile of droxidopa on orthostatic hypotension treatment / prevention in hemodialysis patients.


Eligibility criteria:
inclusion criteria: 1. female or male aged great than 20 years of age 2. patient with at least 3 month documented requirement of regular hemodialysis session 3. patient with a decrease of 20 mmhg in sbp or 10 mmhg in dbp within 5 minutes of standing after the end of hemodialysis in at least 2 of 3 sessions during the screening period. 4. subject with subjective complain of light headedness related to the orthostatic hypotension and with a vas score 4 in at least 2 of 3 sessions during the screening period. 5. willing and able to comply with the study procedure and sign a written informed consent exclusion criteria: 1. female who is pregnant, lactating or planning to be pregnant within 3 months, or female of childbearing potential who is not using medically recognized method of contraception 2. subject with closed angle glaucoma 3. subject with severe hypertension 4. subject with liver disorder 5. subject with hct great than 36% 6. subject with confusion, hallucination, or delusion 7. subject with severe disease which may limit survival during the study period, or confound the results of the study as judged by the investigator, such as hyperthyroidism, artery stenosis, severe lung disorders, severe asthma, chronic open angle glaucoma, uncontrolled diabetic gangrene 8. subject who takes any anti-hypotensive drugs within 7 days prior to randomization, such as midodrine, etilefrine or amezinium 9. subject who takes ephedrine, pseudoephedrine within 7 days prior to randomization 10. subject who use of any investigational product within 4 weeks prior to randomization 11. subject who requires blood transfusions within 3 months before screening, and are not suitable to participate the trial as judged by the investigator 12. histories of hypersensitive to droxidopa 13. histories of peripheral vascular disease, coronary artery disease and are not suitable to participate the trial as judged by the investigator 14. histories of hemorrhage complication within 3 months before the screening visit, such as gi bleeding, intracranial bleeding or traumatic hemorrhage, and are not suitable to participate the trial as judged by the investigator 15. in investigator's opinion, subjects who are unlikely to adequately cooperate and follow the procedures
trial of savvy vaginal gel and hiv in nigeria

Conditions: HIV Infections

Summary: heterosexual contact is now the primary route of transmission for hiv worldwide. this study is a phase 3 trial designed to determine the effectiveness and safety of the 1.0% c31g (savvy) vaginal gel for the prevention of male-to-female transmission of hiv among women at high risk.

heterosexual contact is now the primary route of transmission for hiv worldwide. this study is a phase 3 multi-center, fully-masked, randomized, placebo controlled trial designed to determine the effectiveness and safety of the 1.0% c31g (savvy) vaginal gel for the prevention of male-to-female transmission of hiv among women at high risk.

Eligibility criteria:
inclusion criteria: * 18 to 35 year old women * hiv negative * more than one sexual partner in past 3 months * average 3 coital acts per week * willing to use vaginal gel and condoms for 12 months exclusion criteria: * hiv positive * pregnant

Keywords: hiv seronegativity hiv transmission
dexamethasone-bupivacaine versus bupivacaine for tonsillectomy pain.

Conditions: Tonsillectomy

Summary: investigators compared in this study peritonsillar infiltration of bupivacaine %0.5 (n=40 participants) versus bupivacaine % 0.5 and dexamethasone (number 40participants ) before surgery for reduce posttonsillectomy pain.and control group (n= 40participants) participants received peritonsillar nacl 0,9% .

bupivacaine hydrochloride amid structure,long acting local anesthetic. dexamethasone has strong anti-inflammatory drug reduce postoperative pain and nause and vomiting.preoperative iv dexamethasone is routinely using for reduce tonsillectomy pain.lots of studies show that adding dexamethasone to local anesthetic at peripheral nerve block prolongs the analgesic effect.also preoperative iv dexamethasone prolongs the analgesic effects of local anesthetic infiltration . post tonsillectomy pain still a serious problem ,it effects postoperative morbidity.different medicine combination used to applies for peritonsillar infiltration and multimodal iv and oral medication to reduce posttonsillectomy pain.i̇n this study investigators will use iv dexamethasone for all participants and investigators hypothesis that adding dexamethasone to bupivacaine for peritonsillar infiltration will reduce postoperative pain scores , consumption of rescue analgesic ,patient and family satisfaction.

Eligibility criteria:
inclusion criteria: tonsillectomy surgery for recurrent tonsillitis sleep disorder breathing exclusioncriteria: patients with active upper respiratory tract infection patients with significant cognitive impairment bupivacaine hypersensitivity dexamethasone hypersensitivity taking chronic systemic steroids

Keywords: tonsillectomy pain dexamethasone bupivacaine
capsular tension ring with hydeophilic intraocular lesnes to decrease posterior capsule opacification versus hydrophobic ones

Conditions: Intraocular Lens Complication

Summary: evaluate the clinical outcomes of routine ctr insertion in conjunction with hydrophilic versus hydrophobic iols following phacoemulsification.

phacoemulsification with intraocular lens (iol) implantation is the standard surgical approach for cataract extraction. the choice between hydrophilic and hydrophobic iols has been debated, with studies suggesting differences in posterior capsule opacification (pco) rates and capsular bag stability. capsular tension rings (ctrs) are devices designed to stabilize the capsular bag, particularly in cases with zonular weakness. while ctrs are beneficial in complex cases, their routine use remains controversial. understanding the interaction between ctrs and iol materials could inform surgical practices and improve patient outcomes

Eligibility criteria:
inclusion criteria: * • adults aged 40-80 years. * visually significant cataract (≥3+ on lens opacities classification system iii "locsiii"). * clear cornea. exclusion criteria: * • previous ocular surgery. * zonular instability requiring ctr insertion beyond routine practice. * complicated cataract cases (e.g., traumatic cataract). * active intraocular inflammation or infection.

Keywords: ctr iols phacoemulsification
a phase-ii study of tomudex plus radiotherapy in subject with inoperable or recurrent rectal cancer

Conditions: Inoperable or Recurrent Rectal Cancer

Summary: the pilot study is designed to investigate the value of neo-adjuvant tomudez in combination with radiotherapy in patients with inoperable or recurrent rectal cancer in terms of response rate and increasing the resectability of initially inoperable rectal cancer.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of inoperable/recurrent rectal cancer * age \> 18 years * at least 1 measurable lesion should be present * who performance score \< 2 * life expentancy of at least 12 weeks * subjects will be considered appropriate to receive systemic chemotherapy and pelvic radiotherapy * documented informed consent to participate in the trial exclusion criteria: * previous systemic chemotherapy * previous radiotherapy to the planned exposure area * subjects with distant metastases * (a)white blood cell \ 2.0x109/l or (b) platelet count \< 100x109/l * serum creatinine above the upper limit of the normal range * (a) serum bilirubin \> 1.25 times the upper limit of the normal range or (b) asparate aminotransferase(ast) or alanine amiontransferase (alt) \>2.5 times the upper limit of the normal range * any severe concurrent medical condition which would make it undesirable, in the clinician's opinion, for the patient to participate in the trial or which would jeopardise compliance with the trial period * pregnancy or breast feeding. women of childbearing age must use effective contraception * previous or current malignancies at other sites, with the exception of adequately treated in-situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin * patient participation in other studies

Keywords: tomudex inoperable rectal cancer recurrent rectal cancer
incidental coronary calcification quality improvement project

Conditions: Atherosclerotic Cardiovascular Disease; Coronary Artery Disease

Summary: this is a multi-center, randomized quality improvement project. at least 200 statin-naïve patients without a history of atherosclerotic cardiovascular disease with incidental coronary artery calcium (cac) on a prior non-gated chest ct will be enrolled across the stanford healthcare system and the palo alto veteran's affairs healthcare system. patients will be randomized in a 1:1 fashion to notification or usual care arms. the primary aim of this project is to estimate the increase in 6-month statin prescription among statin-naïve patients without a history of atherosclerotic cardiovascular disease with incidental cac on a non-gated chest ct who are randomized to receive notification of their findings vs. usual care.


Eligibility criteria:
inclusion criteria: * non-gated chest ct between 2014-2019 * the presence of cac confirmed by manual review by an experienced radiologist * stanford affiliated primary care provider or endocrinologist for stanford healthcare system patients and va primary care provider for va patients with at least 1 encounter since 2018 exclusion criteria: * current or prior statin or pcsk9 inhibitor therapy * prior diagnosis of ascvd (coronary artery disease, peripheral arterial disease, cerebrovascular disease, coronary/peripheral revascularization) * prior coronary imaging (cardiac ct, invasive coronary angiography) * dementia * metastatic cancer or active cancer undergoing chemotherapy * history of medical nonadherence

Keywords: coronary calcium statin non-gated chest ct
post-operative cesarean trial of pain control

Conditions: Post-operative Pain; Cesarean Section

Summary: this study plans to learn more about postoperative pain management after cesarean deliveries (c-sections). as a part of standard of care, the children's hospital colorado's colorado fetal care center (cfcc) follows the standard enhanced recovery after cesarean (erac) guidelines to manage pain following c-section delivery. in addition, the cfcc uses an fda approved medical device called the on-q ® pump, which continuously delivers local anesthetic medication to control pain in the area of your procedure. the local anesthetic used is bupivacaine, which is fda approved for use to control local pain after c-sections. the cfcc has found a significant reduction in opioid use after adopting both of these procedures. the study aims to determine if the erac protocol or on-q ® pump continuous infusion is responsible for lower opioid use by comparing bupivacaine (treatment) versus saline (placebo) groups.


Eligibility criteria:
inclusion criteria: * pregnant patients 18 years of age or older * patients undergoing both scheduled and unscheduled cesarean deliveries at cfcc exclusion criteria: * active substance abuse (ex methamphetamines) determined by patient report, toxin screen, or screening physician's determination * current treatment for chronic pain involving opiate receptor agonism or antagonism (i.e. suboxone, methadone, naltrexone, oxycodone) * contraindication to neuraxial anesthesia * known allergies to common anesthetic medications * inability to consent to study procedures * patient receiving general anesthesia
chemotherapy-related toxicities in ovarian cancer patients

Conditions: Ovarian Cancer

Summary: primary objectives: 1. to assess the preferences of women with ovarian cancer, their clinical caregivers, familial caregivers, and a control group for toxicities associated with chemotherapy. * to compare preferences of women with ovarian cancer to preferences of their clinical caregivers. * to compare preferences of women with ovarian cancer to preferences of their familial caregivers. * to compare preferences of women with ovarian cancer to preferences of a women in the control group. 2. to prospectively collect quality of life data from women with ovarian cancer. 3. to prospectively collect symptom assessment data from women with ovarian cancer.

patients in this study will be recruited from the gynecologic oncology clinic waiting area. all participants (patients, family and clinical caregivers, control group women with no cancer) in this study will take part in an interview to see how they feel about the different side-effects of chemotherapy. the interview will involve reading short descriptions of the side-effects and then answering some questions that ask for an opinion. the actual interview will take about 30-45 minutes to complete. the interviews will either take place in private conference rooms in the clinic or in private rooms at the ambulatory treatment center (atc). patients will also be given quality of life and symptom assessment questionnaires. the questionnaires are simple to read and quick to answer. the questionnaire takes about 15 minutes to complete. the participant's involvement in this study is limited to the questionnaire/interview. once that is done, the participant is finished with the study. this is an investigational study. a total of 288 people will take part in this study. all will be enrolled at m. d. anderson.

Eligibility criteria:
inclusion criteria: 1. women with epithelial ovarian cancer presenting to the utmdacc gynecologic oncology clinic who are currently undergoing chemotherapy 2. women with a history of epithelial ovarian cancer presenting to the utmdacc gynecologic oncology clinic who are seen in follow-up 3. women who are at least 18 years of age 4. women who speak english 5. clinical caregivers of patients with ovarian cancer (utmdacc gynecologic oncologists, utmdacc gynecologic medical oncologists, utmdacc registered nurses and licensed vocational nurses in the utmdacc gynecology clinic, and utmdacc gynecologic oncology fellows and residents) 6. familial caregivers of patients with ovarian cancer (primary caregiver) exclusion criteria: 1. participants who are non-english speakers 2. participants who are less than 18 years of age

Keywords: ovarian cancer quality of life chemotherapy side-effects interview questionnaire caregivers
dry vs wet misoprostol for cervical dilation in first trimester abortion

Conditions: Abortion Early

Summary: this study aims to verify whether the moisture of 400 µg of misoprostol pre uterine evacuation increases the dilatation of uterine cervix compared to dry misoprostol

misoprostol is the most widely used drug for abortion due to its low cost, stability and easy to use regimen. nevertheless, there is a debate whether the administration of dry misoprostol has similar effects compared to wet pill. it would be necessary to undertake a clinical trial to evaluate which regimen (dry or wet) offers a better cervical dilation pre uterine evacuation. the primary objective of this study is to compare the degree of cervical dilatation pre-uterine evacuation in subject that received 400 µg of dry or wet misoprostol 3 or more hours before the procedure. secondary objective is to verify whether there is a correlation between vaginal ph (\<5 / ≥5) and the degree of cervical dilation (≥8mm / \<8mm) with the use of wet or dry misoprostol. women will be randomized to one of the two groups: dry or wet misoprostol.

Eligibility criteria:
inclusion criteria: * women with abortion (less than 12 weeks of pregnancy) exclusion criteria: * congestive heart failure * chronic pulmonary disease * hypovolemic shock * twins * marfan syndrome * septic abortion (fever, pus , leukocytosis \>14,000) * known allergies to misoprostol * blood dyscrasia * open cervical (≥ 1cm) * use of intrauterine device

Keywords: misoprostol abortion