Kornimate/medical-research-clean huggingface dataset:
research development13(rd13)-02 cell injection in patients with relapsed or refractory cluster of differentiation 7(cd7)-positive hematological malignancies

Conditions: Neoplasms; Hematologic Neoplasms; Neoplasms by Site; Hematologic Diseases

Summary: this is a single-arm, open-label, single-center, phase i study. the primary objective is to evaluate the safety of cd7 chimeric antigen receptor-t(car-t) therapy for patients with cd7-positive relapsed or refractory t-acute lymphoblastic leukemia(all)/lymphoblastic lymphoma(lbl)/acute myelogenous leukemia(aml), and to evaluate the pharmacokinetics of cd7 car-t in patients。


Eligibility criteria:
inclusion criteria: 1. age 3-70 2. diagnosis of r/r t-all/lbl/aml. 3. cd7 positive expression 4. bone marrow lymphoblasts ≥5% by morphologic evaluation at screening 5. creatinine clearance (as estimated by cockcroft gault) ≥ 60 ml/min, serum alanine aminotransferase(alt)/aspartate aminotransferase(ast) \< 3×upper limit of normal, total bilirubin \< 1.5×upper limit of normal or ≤1.5mg/dl 6. left ventricular ejection fraction ≥ 50% . 7. baseline oxygen saturation ≥ 92% on room air. 8. eastern cooperative oncology group (ecog) performance status of 0 to 2. 9. the estimated survival time is more than 3 months. 10. subjects or their legal guardians volunteer to participate in the study and sign the informed consent. exclusion criteria: 1. subjects with concomitant genetic syndromes associated with bone marrow failure states. 2. isolated extramedullary lesions 3. subjects with some cardiac conditions will be excluded. 4. with uncontrolled active central nervous system leukemia (cnsl), cerebrospinal fluid grade central nervous system3(cns3). 5. history of traumatic brain injury, consciousness disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic disease, which might compromise the ability of the subject to compliance with the obligations under the protocol. 6. history of malignancy other than non-melanoma skin cancer or carcinoma. 7. primary immune deficiency. 8. presence of uncontrolled infections. 9. subjects with some anticancer therapy before car-t infusion will be excluded. 10. active uncontrolled acute infections. 11. known history of infection with human immunodeficiency virus (hiv); active or latent hepatitis b, hepatitis c and syphilis. 12. subjects who are receiving systemic steroid therapy prior to screening. 14.having received live/attenuated vaccine within 4 weeks prior to screening. 15.history of allergy to any component of the cell therapy product. 16.pregnant or breastfeeding women 17.any other issue which, in the opinion of the investigator, would make the subjects ineligible for the study.
black cohosh extract for the management of moderate to severe menopausal symptoms in thai women

Conditions: Hot Flashes

Summary: cimicifuga racemosa (black cohosh) rhizome and root extract have been used to treat menopausal symptoms. to date, there are still scarce information about its efficacy in thai women with menopausal symptoms. the purpose of this study will assess the efficacy of black cohosh extract in management of menopausal symptoms in thai women.


Eligibility criteria:
inclusion criteria: * thai women, aged ≥ 40 years * peri- or postmenopause * moderate to severe menopausal symptoms from kupperman menopausal index score at least 20 exclusion criteria: * using any drugs or hormonal treatment within 1 month before enrollment * bmi ≥ 30 kg/m2 * allergic to drugs or any ingredient * liver disease or ast ≥ 37 u/l or alt ≥ 40 u/l or total bilirubin ≥ 1 mg/dl or direct bilirubin ≥ 0.3 mg/dl * psychiatric disease * alcohol consumption or any elicit drug use * vegetarian (may consume more phytoestrogen)

Keywords: back cohosh cimicifuga racemosa menopausal symptoms hot flashes kupperman index menqol
effects of manual therapy combined with therapeutic exercise on brain biomarkers in neck pain

Conditions: Neck Pain

Summary: structural brain alterations in pain-related areas have been demonstrated in patients with nonspecific neck pain. while manual therapy combined with therapeutic exercise is an effective management for neck pain, its underlying mechanisms are poorly understood. the primary objective of this trial is to investigate the effects of manual therapy combined with therapeutic exercise on brain imaging biomarkers in patients with chronic nonspecific neck pain. the secondary objectives are to assess neurochemical biomarkers, clinical features of neck pain, cervical range of motion and cervical muscle strength.

this study is a single-blinded, randomized controlled trial. forty-eight participants with chronic nonspecific neck pain will be recruited into the study. participants will be randomly allocated to either an intervention or control group (1:1 ratio). participants in the intervention group will receive manual therapy combined with therapeutic exercise for 10 weeks (2 visits per week). the control group will receive routine physical therapy. primary outcomes are brain imaging biomarkers (cortical gray matter: volume, thickness and area, and white matter: fractional anisotropy and mean diffusivity) in pain-related areas. secondary outcomes are neurochemical biomarkers (n-acetylaspartate, naa; creatine, cr; glutamic acid/glutamine, glu/gln; myoinositol, mi; and choline, cho), clinical features (neck pain intensity, duration, neck disability and psychological symptoms), cervical range of motion and cervical muscle strength.

Eligibility criteria:
inclusion criteria: * a history of nonspecific neck pain for ≥ 3 months * an average pain intensity over the past week ≥ 35 mm. on a visual analogue scale (vas) exclusion criteria: * a history of head and neck injury or surgery * known or suspected vestibular pathology or dizziness caused by underlying pathology in the ear, brain and sensory nerve pathways (e.g. benign paroxysmal positional vertigo) and/or vascular disorders * any neurological or musculoskeletal condition that could affect the outcomes (e.g., scoliosis, torticollis, myofascial pain syndrome, fibromyalgia and rheumatoid arthritis) * metabolic conditions (e.g., diabetes, obesity (bmi \> 30 kg/m2) and hypertension) * psychological symptoms (e.g., anxiety, depression and schizophrenia) * contraindications to mri (e.g., pregnancy/breastfeeding, claustrophobia and ferromagnetic implants) * receiving physiotherapy treatment for their neck conditions in the past 12 months.

Keywords: neck pain manual therapy exercise magnetic resonance imaging magnetic resonance spectroscopy
a study of anti-pd-1 and lag-3 bispecific antibody(ak129) combined with chemotherapy with or without cadonilimab in the first-line treatment of unresectable locally advanced or metastatic g/ gej adenocarcinoma

Conditions: Gastric Adenocarcinoma; Gastroesophageal Junction Adenocarcinoma

Summary: phase ib/ii clinical study of ak129 combined with chemotherapy with or without cadonilimab in first-line treatment of advanced her2 negative gastric cancer or gastroesophageal junction adenocarcinoma


Eligibility criteria:
inclusion criteria: 1. the subject must sign the written informed consent form(icf) voluntarily. 2. aged ≥ 18 to ≤ 75 years,male and female at the time of signing the icf. 3. histologically confirmed adenocarcinoma of the gastric or gastroesophageal junction (gej). 4. inoperable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma. 5. participants had not previously received systemic therapy for locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma. 6. according to recist v1.1 criteria, subjects had at least one measurable tumor target. exclusion criteria: 1. subjects with known her2 positive gastric or gastroesophageal junction adenocarcinoma. 2. histopathological examination confirmed other pathological types. 3. had received palliative local therapy for non-target lesions within 2 weeks before the first administration. 4. past treatment with immune checkpoint inhibitors,immune checkpoint agonists,immune cell therapy and any treatment targeting the immune mechanism of tumor action. 5. history of gastrointestinal perforation and fistula within 6 months before the first dose. 6. active or previously documented inflammatory bowel disease,inability to swallow, malabsorption syndrome. 7. active malignancy within the last 3 years. 8. active or untreated brain metastases, meningeal metastases, spinal cord compression, or pia meningeal disease are known to exist. 9. the presence of clinical symptoms of pleural effusion, pericardial effusion, or abdominal effusion, or the need for frequent drainage. 10. there was an active autoimmune disease that required systemic treatment within 2 years prior to the start of the study.
micardis®. observational study in patients with essential hypertension

Conditions: Hypertension

Summary: this study is designed to supplement, under conditions of usual clinical practice, the data on the efficacy and safety of micardis® collected during the clinical studies.


Eligibility criteria:
inclusion criteria: * patients of either sex over the age of 18 years suffering from essential hypertension requiring treatment according to the physician exclusion criteria: * hypersensitivity to the active component or to any of the excipients * pregnancy and lactation * biliary obstructive disorders * severe hepatic impairment * severe renal impairment
analgetic effect of nitrousoxide-oxygen inhalation for dental treatment of children

Conditions: Dental Pain; Muscle Sensitivity to Pressure; Skin Sensitivity to Electric Stimulation

Summary: to assess the analgetic effect of nitrousoxide-oxygen inhalation on pain perception in 12-15 years old children from 1) the dental pulp; 2) the masseter muscle; 3) the skin on the upper lip

the present study is a randomized, cross-over blinded study on the analgetic effect of nitrousoxide-oxygen on sensitivity of the dental pulp, the skin and muscles. it is conducted in healthy 12-15 year old danish children attending public schools in the municipality of aarhus, denmark

Eligibility criteria:
inclusion criteria: * asa-groups i or ii * 12-15 year of age * sound upper central incisors exclusion criteria: * difficulties breathing through the nose * pregnancy * trauma to test teeth

Keywords: children analgesia dental treatment inhalation
a multicenter clinical trial on laparoscopic gastric cancer surgery compared with open surgery

Conditions: Locally Advanced Gastric Cancer

Summary: evaluate the long-term efficacy and safety of oncology between d2 laparoscopic approach distal gastric resection (distal gastrectomy, d2 lymph node dissection) with the current standard surgical treatment model d2 open approach distal gastric resection (distal gastrectomy, d2 lymphadenectomy).

study type：interventional study phase：phase iii objectives of study：to evaluate the long-term efficacy and safety of oncology between d2 laparoscopic approach distal gastric resection (distal gastrectomy, d2 lymph node dissection) with the current standard surgical treatment model d2 open approach distal gastric resection (distal gastrectomy, d2 lymphadenectomy).

Eligibility criteria:
inclusion criteria: 1. 18 years \~ 75 years; 2. the primary adenocarcinoma (papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, signet ring cell carcinoma, poorly differentiated adenocarcinoma); 3. clinical stage t2-4a, n0-3, m0 (according to ajcc-7th tnm staging); 4. to perform distal gastrectomy, d2 lymph node dissection surgical can obtain r0 resection (multiple primary cancers also apply) 5. ecog performance status 0/1; 6. asa score i-iii; 7. patient informed consent. exclusion criteria: 1. pregnant or lactating women; 2. serious mental illness; 3. upper abdominal surgery (except laparoscopic cholecystectomy ); 4. gastric surgery (including for gastric esd / emr); 5. imaging examinations showed regional integration lymph nodes (maximum diameter ≥ 3cm) 6. other malignant diseases in 5 years; 7. implemented or recommended neoadjuvant therapy in patients with gastric cancer ; 8. have unstable angina or myocardial infarction within six months; (9) have cerebral infarction or cerebral hemorrhage within 6 months; (10) sustained systemic glucocorticoid treatment history within 1 month; (11) have other diseases needed operative treatment at the same time; (12) complications (bleeding, perforation, obstruction) required emergency surgery; (13) pulmonary function tests fev1 \<50% of predicted value.
promoting optimal healing after laceration repair study

Conditions: Neuralgia, Perineal

Summary: the goal of this research is to investigate three different methods of perineal skin closure during second-degree perineal wound repair and determine which method is associated with the least amount of patient pain. null hypothesis: there will be no difference in patient pain among the three different methods for second degree perineal wound repair.

at the university of michigan, there are currently two standard techniques for repairing second-degree perineal lacerations that differ only in management of the perineal skin : 1. closure of the deep tissues and superficial perineal skin using a continuous 3-0 vicryl suture 2. closure of the deep tissues with a continuous 3-0 vicryl suture and reapproximation of, but not suture-closure of the perineal skin. the primary goal of our study is to compare patient pain amongst the following three perineal skin repair techniques after second degree laceration: 1. perineal skin closure with suturing 2. not suturing the perineal skin 3. closure of the perineal skin with n-butyl 2-cyanoacrylate (indermil®) surgical glue. in all women, the deep vaginal and perineal tissues will be closed using a continuous 3-0 vicryl suture, as is current standard practice. aim: to assess and compare patient pain among the three groups at intervals of 1 day, 2 weeks, 6 weeks and 3 months postpartum.

Eligibility criteria:
inclusion criteria: * women 18 years old - 45 years old * immediately post-vaginal birth, including forceps-assisted vaginal delivery, vacuum-assisted vaginal delivery * \> 32 weeks gestation * second degree laceration from spontaneous tear or midline episiotomy * proficient in english exclusion criteria: * \ 45 years old * delivery by cesarean * 1st, 3rd or 4th degree lacerations * induction for intrauterine fetal demise or terminal fetal condition, or any instance where immediate status of the newborn is unknown * known allergy to cyanoacrylate or formaldehyde * systemic infections, uncontrolled diabetes (women with well-controlled pre-gestational or gestational diabetes will not be excluded) * history of connective tissue disorders (e.g. scleroderma, ehlers danlos) * chronic use of steroids * currently under treatment for cancer * previous radiation to the pelvis * any organ transplants * history of neurological conditions including multiple sclerosis, stroke, alzheimer's, or other dementias * not proficient in the english language

Keywords: perineal wound perineal tear perineum pain childbirth
a study of istradefylline (kw-6002) for the treatment of parkinson's disease

Conditions: Parkinson's Disease

Summary: the purpose of this study is to evaluate the efficacy of 40 mg a day of istradefylline (kw-6002) for reducing the percentage of awake time spent in the off state in patients with advanced parkinson's disease treated with levodopa.

parkinson's disease (pd) is a progressive motor disease characterized by bradykinesia or akinesia, rigidity, and resting tremor. levodopa is still the most widely used treatment for pd, but as the disease progresses the drug tends to become less helpful. this is because of the development of motor response complications such as end-of-dose deterioration or wearing-off, peak dose dyskinesias, and on-off phenomenon. comparison(s): the safety of 40 mg/d istradefylline and the efficacy for reducing the percentage of off time in patients with advanced pd treated with levodopa will be compared to placebo. the safety and efficacy of entacapone will also be compared to placebo.

Eligibility criteria:
inclusion criteria: patients selected for this study will be at least 30 years of age and will have been diagnosed with advanced parkinson's disease as determined by uk parkinson's disease society (ukpds) criteria and the modified hoehn and yahr scale. the patients will have been receiving levodopa treatment for at least one year, may be taking other antiparkinsonian drugs, will have an average of at least three hours off time as recorded in two 24-hour on/off diaries, and if female, must be non-pregnant and non-nursing. exclusion criteria: patients may not be enrolled if they are taking certain medications excluded by the protocol, have been treated with any investigational drug within 30 days prior to randomisation (or five half-lives if longer), have ever received istradefylline or been treated with a comt inhibitor, are psychotic, have clinically significant illness or laboratory values at screening, have insufficient mental capacity to comply with protocol requirements or certain psychiatric or neurological conditions. -

Keywords: kw-6002 (istradefylline) entacapone placebo parkinson's disease motor response complications levodopa therapy
a randomized clinical trial of hydrocortisone augmentation of prolonged exposure

Conditions: Post Traumatic Stress Disorder

Summary: this study seeks to examine the efficacy of hydrocortisone administration in the augmentation of the therapeutic effects of prolonged exposure (pe) therapy, an empirically tested treatment shown to be effective in the the treatment of posttraumatic stress disorder (ptsd). the augmentation builds on both the translation of neuroscience findings demonstrating the effects of glucocorticoids (gcs) on learning, and on empirical clinical findings from other investigators demonstrating beneficial effects of gcs in reducing traumatic memories in trauma-exposed persons.


Eligibility criteria:
inclusion criteria: * age 18 to 89 * capable of understanding, reading, and writing in english * oif/oef veteran with criterion-a trauma while deployed * minimum ptsd severity of 60 (caps) * unmedicated or on a stable psychotropic regimen (i.e., 1 or more months on the same regimen) exclusion criteria: * lifetime history of psychotropic disorder, bipolar disorder, or obsessive compulsive disorder * moderate or severe traumatic brain injury (tbi) * a medical or mental health problem other than ptsd that requires immediate clinical attention * substance abuse or dependence within the last 3 months * suicidal risk (as determined by response of 5 or 6 on the suicidality items of the montgomery-asberg depression rating scale (madrs)) and/or assessed suicide risk on the basis of clinical judgment * persons on a psychotropic medication regimen that has not been consistent for one month * presence of diabetes mellitus or any current unstable medical illness or condition that represents a contraindication to taking glucocorticoids (this will be determined by history and/or abnormal laboratory findings at medical clearance) * unwillingness to discontinue other specialized psychotherapy for ptsd during the 11 weeks of study treatment and the 3 month follow-up (self-help (non-trauma focused) groups or supportive counseling can be continued but not initiated) * pregnant women or those planning to become pregnant within the study period will not be enrolled. female participants must agree to use an effective method of birth control (i.e., oral contraceptive, norplant, diaphragm, condom, or spermicide, abstinence) during the course of the study to ensure they do not become pregnant during the course of the study

Keywords: ptsd
aging, beta blockers, and thermoregulatory responses

Conditions: Heat Stress; Aging

Summary: this study will test the hypothesis that the drugs propranolol and metoprolol will result in greater increases in core body temperature during 3 hours of extreme heat exposure in older adults.

older individuals are more likely to die or become ill during heat waves. during the 1995 chicago heat wave, there was 35% increase in hospital admissions for individuals older than 65 years of age. moreover, adults over the age of 65 have a heat-related death rate that is more than double any other age group. therefore, with an increasing elderly population that is expected to rise by 60% (to 78 million) by 2035, the causes of this excess mortality must be understood to better protect the ageing united states population. it is notable that selective and non-selective beta blocker drugs are commonly prescribed to older individuals with cardiovascular diseases. in younger individuals exposed to a heat stress, beta blocker administration reduced whole-body sweat rate and skin blood flow responses resulting in greater increases in core body temperature. notably, nothing is known regarding the effects of beta blockers on thermoregulatory responses during heat exposure in older individuals. this project will evaluate core body temperature responses to selective and non-selective beta blocker drugs during simulated heat wave exposure in older individuals.

Eligibility criteria:
inclusion criteria: * healthy and free of any significant medical problems * normal resting electrocardiogram * 65+ years of age * controlled cholesterol of less than 200 mg/dl * controlled blood pressure of less than 140/90 mmhg exclusion criteria: * known diseases or other chronic conditions requiring regular medical therapy including cancer, diabetes, neurological diseases, uncontrolled hypertension, and uncontrolled hypercholesterolemia * serious abnormalities detected on routine screening * taking prescribed medications or over-the-counter medications that have known influences on either cardiac function or sweating * current smokers, as well as individuals who regularly smoked within the past 3 years * body mass index ≥31 kg/m2