Kornimate/medical-research-clean huggingface dataset:
assessment of cellular proliferation in tumors by positron emission tomography (pet) using [18f]iso-1

Conditions: Breast Cancer; Head and Neck Cancer; Diffuse Large B-cell Lymphoma

Summary: the main purpose of this study is to see if positron emission tomography (pet) imaging with a radioactive tracer called 18f-iso-1 can accurately identify how quickly cancer cells are growing or dividing. a second purpose for this study is to determine, by taking pictures, what tissues and organs of the body take up 18f-iso-1 naturally and to determine how that uptake changes over time.


Eligibility criteria:
inclusion criteria: * patients 18 years of age or older with biopsy-proven breast cancer, head \& neck cancer or diffuse large b-cell lymphoma. * for determination of ki-67, s-phase, mitotic index, and sigma-2 receptor assessment, cancer subjects must be scheduled to undergo surgical resection of the primary tumor without intervening therapy, or be scheduled to undergo (or have already undergone) tissue sampling as either standard of care or part of another research project prior to any planned treatment for their cancer. for tumor sigma-2 receptors assessment, about 0.5 g of fresh tumor tissue kept frozen on dry ice is needed, other proliferative markers may be determined on a much smaller specimen. thus, it is possible that the analysis of sigma-2 receptors may not be possible in all patients, as obtaining 0.5 g tumor specimen may not practical in all patients. * newly diagnosed breast cancer, head \& neck cancer, or diffuse large b-cell lymphoma subjects should have a primary lesion size ≥ 1.5 cm as determined by imaging studies (ultrasonography, mammography, ct or mri) or physical examination and who have not received any treatment for their cancer. * able to give informed consent. * not currently pregnant or nursing: female subjects must be either surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), or post menopausal (cessation of menses for more than 1 year). if of childbearing potential, a urine pregnancy test must be performed within the 24 hour period immediately prior to administration of \[18f\]iso-1 and determined to be negative. exclusion criteria: * patients with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of the other cancer present within the last 5 years. lymphoma patients who have received treatment in the past but have a new diagnosis of diffuse large b-cell lymphoma are eligible to participate providing they will undergo tissue sampling as specified in the inclusion criteria. * unable to tolerate 60-90 minutes of pet imaging.

Keywords: breast cancer head and neck cancer diffuse large b-cell lymphoma cellular proliferation
sequential treatment of postmenopausal women with primary osteoporosis (fp-001-im)

Conditions: Osteoporosis

Summary: the objective is to show superior efficacy of pth (1-84) over risedronate in treating osteoporotic women for 12 months after having previously been treated with pth (1-84) for 12 months followed by 12 months treatment with risedronate.


Eligibility criteria:
inclusion criteria: women above the age of 50 years with the diagnosis of postmenopausal primary osteoporosis may be enrolled in the trial if the following inclusion/exclusion criteria apply. all inclusion criteria must be answered "yes" for a subject to be enrolled in the trial. 1. has the subject given informed consent according to local requirements before any trial related activities? (a trial related activity is any procedure that would not have been performed during the routine management of the subject). 2. is the subject above 50 years old? 3. is the subject postmenopausal (more than 5 years) - in the judgement of the investigator? 4. does the subject have primary osteoporosis with a lumbar spine t score \< -3.0 sd (at lumbar spine l1-l4, with a minimum of two evaluable vertebrae)? 5. does the subject have a life expectancy of \>3 years? 6. is the subject able to self-inject pth (1-84), (or to have pth (1-84) injection by a helper)?

Keywords: lumbar spine bone mineral density (bmd)
cd19-targeted car t cells for relapsed or refractory (r/r) large b-cell lymphoma

Conditions: Non-Hodgkin Lymphoma; Large B-cell Lymphoma

Summary: this is an open-label, single-arm study to treat the adult r/r large b-cell lymphoma subjects with relmacabtagene autoleucel (relma-cel) in china.

this is an open-label, single-arm study conducted in adult subjects with r/r lbcl in china to evaluate efficacy，safety and pharmacokinetics(pk) of relma-cel. relma-cel was approved by the china national medical products administration(nmpa)in september 2021(acceptance no:cxss2000036)for the treatment of adult patients with r/r lbcl after second-line or more systemic therapy.the recommended dose is 1×10\^8 car+t cells.the indication for this application is r/r lbcl and the recommended dose is 1×10\^8 car+t cells.

Eligibility criteria:
inclusion criteria: 1. ≥18 years old; 2. sign on the informed consent; 3. subjects must have histologically confirmed large b-cell lymphoma; 4. subjects had been treated with anthracyclines and rituximab(or other cd20-targeted antibodies) and had relapsed, failed to respond, or progressed after at least two lines of therapy including autologous hematopoietic stem cell transplantation(auto-hsct); 5. subjects have accessible pet-positive lesion and have measurable ct-positive lesion according to lugano classification; 6. eastern cooperative oncology group(ecog) performance status of 0 or 1; 7. adequate organ function; 8. adequate vascular access for leukapheresis procedure; 9. subjects who have previously received cd19 targeted therapy must confirm that lymphoma lesions still express cd19; 10. women of childbearing potential must agree to use highly effective methods of contraception for 1 year after the last dose of relma-cel; 11. males who have partners of childbearing potential must agree to use an effective barrier contraceptive method for 1 year after the last dose of relma-cel. exclusion criteria: 1. primary cns lymphoma; 2. history of another primary malignancy that has not been in remission for at least 2 years; 3. subjects has hbv,hcv,hiv or syphilis infection at the time of screening; 4. active deep venous thrombosis(dvt)/pulmonary embolism(pe),or active dvt/pe requires anti-coagulation within 3 months prior to signing the icf; 5. subjects with uncontrolled systemic fungal,bacterial,viral or other infection; 6. presence of acute or chronic graft-versus-host disease(gvhd); 7. history of any serious cardiovascular disease or presence of clinically relevant cns pathology; 8. pregnant or nursing woman; 9. subjects using of any chemotherapy,corticosteroid,experiment agents,gvhd therapies,radiation,allo-hsct or any other therapies for lymphoma must go through a specific wash-out period before leukapheresis; 10. uncontrolled conditions or unwillingness or inability to follow the procedures required in the protocol; 11. received car t-cell or other genetically-modified t-cell therapy previously.

Keywords: jwcar029 b-cell malignancies car t cells chimeric antigen receptor relapsed/refractory
optimizing the efficiency and implementation of cash transfers to improve adherence to antiretroviral therapy

Conditions: HIV/AIDS; Adherence, Medication; Adherence, Patient

Summary: 1. determine the "dose-response" relationship between a cash transfer amount and hiv viral suppression at 6 months 2. identify the most effective cash transfer size to increase the proportion of people living with hiv infection (plhiv) retained in care and with suppressed viral load (\<1000 copies/ml) after 6 months. (this amount will be further evaluated in a cluster randomized trial in phase 2).

participants in the control group will receive the standard hiv primary care services according to tanzania's national guidelines for the management of hiv and aids. the study has two active intervention arms: 1. the opportunity to earn 10,000 tzs/month (\~$4.50) for up to 6 months conditional on visit attendance, and 2. the opportunity to earn 22,500 tzs/month (\~$10.00) for up to 6 months conditional on visit attendance in both intervention arms, cash transfers will be delivered a maximum of once monthly, spaced ≥28 days apart, for up to six months and delivered via an automatic mobile money system linked to a biometric identification system.

Eligibility criteria:
inclusion criteria: * ≥18 years * living with hiv infection * initiated antiretroviral therapy ≤1 month prior to enrollment in the study exclusion criteria: - participants who do no provide informed consent
safety and efficacy study of ym087 (conivaptan) in patients with acute decompensated heart failure

Conditions: Chronic Heart Failure

Summary: this is a randomized, double-blind, placebo-controlled, dose ranging pilot study to examine the effects of conivaptan in patients with acute decompensated heart failure.


Eligibility criteria:
inclusion criteria: * patients may be male or female age 18 years or older. * women must be post-menopausal or surgically sterile. * patients must have chronic heart failure of at least 2 months duration and be hospitalized for the treatment of worsening heart failure. the primary manifestation of worsening heart failure must be worsening dyspnea.

Keywords: chronic heart failure ym078
coronary and structural interventions ulm - bioresorbable vascular scaffold

Conditions: Coronary Artery Disease; Ischemic Heart Disease; Stable Angina; Unstable Angina; Acute Myocardial Infarction

Summary: to evaluate the safety, performance and efficacy of the bioresorbable vascular scaffold (bvs) system in patients with coronary artery disease

patients with coronary artery disease receive bioabsorbable vascular scaffolds. patients are clinically followed during a period of 10 years.

Eligibility criteria:
inclusion criteria: * coronary artery disease * implantation of at least one bioresorbable vascular scaffold exclusion criteria: * no written informed consent
effect of prednisone and aspirin on ivf-et outcome among patients with thyroid autoimmunity

Conditions: Thyroiditis, Autoimmune; Infertility

Summary: this trial was a 1:1 (active:placebo) randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of prednisone and aspirin for the in vitro fertilization and embryo transfer outcome among patients with thyroid autoimmunity.


Eligibility criteria:
inclusion criteria: 1. tpoab\>34iu/ml and/or tgab\>115iu/ml 2. ≥5 follicles with average diameter lager than 14 mm at trigger day 3. ≥5 oocytes retrieved 4. for frozen embryo transfer, at least 2 cleavage stage embryos, among which at least one morphologically good quality embryo, or at least 1 morphologically good quality embryo in blastocyst stage 5. age: 20-38 years old 6. patients whose written icf approved by the ec has been obtained, after having been duly informed of the nature of the study and voluntarily accepted to participate after being fully aware of the potential risks, benefits and any discomfort involved. meet item 1, 5, 6, and one of item 2, 3, 4. exclusion criteria: * hyperthyroidism * intrauterine adhesion * with endometrium thickness less than 6mm * uterine malformation * pgt * with other autoimmune diseases need glucocorticoid or aspirin treatment * gluacoma * gastric ulcer
brain hippocampal volume relationship with anxious symptoms in major depressive patients

Conditions: Major Depressive Disorder; Anxiety Disorders

Summary: the objective of this transversal study is to determine if there is a difference in the volume of the hippocampus with the degree of anxiety.


Eligibility criteria:
inclusion criteria: * first-time patients, without prior antidepressant treatment that meet the diagnostic criteria of dsm 5 for major depressive disorder. * patients who meet the current major depressive disorder criteria in the mini interview. * patients who signed the informed consent for the investigation. exclusion criteria: * patients presenting insufficient data in the mini interview for current major depression. * patients diagnosed with intellectual development disorder, by clinic. * patients with diagnosis of the schizophrenic spectrum, bipolar disorder, autism spectrum disorder, post-traumatic stress disorder and obsessive-compulsive disorder by clinic and / or by the mini interview. * patients with contraindications for mri. * patients with serious or unstable medical problems. * patients undergoing some legal procedure. * patients with difficulties in understanding the interview or completing the assessment instruments.

Keywords: major depressive disorder hippocampal volume cortisol c-reactive protein brain metabolites mri anxiety
effects of intra-operative ropivaciane epidural injection on post-operative outcomes following elective lumbar fusion

Conditions: Pain, Postoperative

Summary: the following is a double blinded, randomized controlled clinical trial to test the hypothesis that a single epidural injection of ropivaciane® intra operatively will:1) single intra-operative epidural injection of ropivaciane® will result in decreased postoperative pain and opioid use in both minimally invasive (mis) and open lumbar fusion patients; 2) decreased postoperative pain will lead to improved clinical outcomes; and 3) elucidate if there are differences in pain management between mis and open surgical procedures. the proposed study will add novel information to current knowledge by 1) exploring of the effects of intra-operative single epidural injection analgesic on patients receiving mis compared to open surgery, and 2) investigate potential immediate and short-term functional improvements gained from intra-operative single injection of ropivaciane®.

this double blinded, randomized clinical trial will test hypotheses by administering a single epidural injection prior to wound closure of either ropivaciane® or saline.all pre-surgical activities and anesthesia will proceed as usual, with the addition of a single epidural injection immediately prior to wound closure 2 levels, or 10cm above the operated spinal level. experimental groups will receive 0.2% ropivaciane® (10 ml; dose shown to be effective without transient weakness), 9 and the control group will receive 0.9% saline solution (10 ml). accurate placement into the space will be verified by the injection of contrast medium (iohexol, 180 mgl/ml) under fluoroscopic guidance. epidural solutions will be prepared prior to surgery by pharmacy and coded; surgeons will administer according to the patient's code maintaining the double-blind procedure. it is important to note that treatment as usual differs between open and mis cohorts. the question of interest is whether the addition of the epidural analgesic to current practices for each surgery type results in increased positive outcomes, whether this is due to synergistic effects or not. following operative treatment, foley urinary catheter will be removed 24 hours post-operatively, unless otherwise clinically indicated.

Eligibility criteria:
inclusion criteria: * consenting participants undergoing elective 1-2 level lumbar fusion through the canada east spine centre exclusion criteria: * history of severe respiratory, renal or hepatic disease * previous spine surgery * known allergy to local anaesthesia * those who experience dural tear during operative procedure

Keywords: pain analgesic spinal fusion
acqforce pulsed field ablation-ce

Conditions: Atrial Arrhythmia; Atrial Fibrillation

Summary: the pulsed field ablation system study for atrial fibrillation (pfa-af)

this clinical study is designed to evaluate the safety and performance of the pfa system in the ablation treatment of atrial fibrillation (af). data will be used to support regulatory submissions.

Eligibility criteria:
inclusion criteria: 1. male or female between the ages of 18 to 80 years at time of consent 2. clinically indicated and scheduled for a de novo catheter ablation of af 3. willing and able to provide written informed consent to participate in the study and agree to comply with all follow-up visits and evaluations for the duration of the study. exclusion criteria: 1. in the opinion of the investigator, any contraindication to the planned atrial ablation, including anticoagulation contraindications, atrial thrombus, renal failure, or sepsis. 2. continuous episodes of af duration lasting longer than 12-months 3. atrial arrhythmias secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiac cause. 4. previous history of left atrial ablation (including surgical treatment) for af/at/afl. 5. structural heart disease or cardiac history as described below: 1. left ventricular ejection fraction (lvef) \< 35% 2. left atrial size \> 60 mm 3. evidence of heart failure (nyha class iii or iv) 4. unstable angina or ongoing myocardial ischemia 5. recent myocardial infarction 6. severe uncontrolled systemic hypertension 7. moderate or severe valvular heart disease (stenosis or regurgitation). 8. interatrial baffle, closure device, patch, or patent foramen ovale (pfo) occluder. l. presence of a left atrial appendage occlusion device. j. previous pv stenting or evidence of pv stenosis. 6. body mass index (bmi) \> 42 kg/m2 7. history of blood clotting or bleeding disease. 8. any prior history of documented cerebral infarct (stroke), or systemic embolism (excluding post-operative deep vein thrombosis (dvt)). 9. history of obstructive sleep apnea not currently being treated. 10. pregnant or lactating (current or anticipated during study follow-up). 11. any other condition that, in the judgment of the investigator, makes the patient a poor candidate for this procedure, the study or compliance with the protocol (includes vulnerable patient population, mental illness, addictive disease, terminal illness with a life expectancy of less than two years, extensive travel away from the research center).

Keywords: atrial fibrillation ablation pulsed field ablation (pfa)
study of chemotherapy with adoptive cellular therapy with dc-cik cells in triple negative breast cancer patients

Conditions: Breast Neoplasms; Neoplasm Metastasis

Summary: to access the effectiveness of cyclophosphamide combined thiotepa and carboplatin chemotherapy combined with adoptive cellular therapy with dendritic and cytokine-induced killer cells in triple negative metastatic breast cancer patients

1. metastatic breast cancer patients should be definitively diagnosis based on histopathology, with er-negative and pr-negative, fish testing for her-2-negative 2. all the patients enrolled will be given standard cyclophosphamide combined thiotepa and carboplatin chemotherapy and cellular therapy.cellular therapy consisting of one cycle of chemotherapy followed by an apheresis and ex vivo cultures to generate dc and cik, followed by low-dose oral cyclophosphamide . 3. the response is assessed using response evaluation criteria in solid tumor group (recist) guidelines. 4. estimate time to progression, survival rates and clinical benefit response on patients. 5. find biomarkers associated with drug response.

Eligibility criteria:
inclusion criteria: * failure to anthracycline and/or taxol chemotherapy; * metastatic tumor is histologically confirmed by immunohistochemical staining to be er-negative and pr-negative. fish testing for her-2-negative; * metastatic tumor can not be removed through surgery procedure; * an eastern cooperative oncology group (ecog) performance status of 0-2; * normal cardiac, hepatic, renal and bone marrow functions; * life expectancy ≥3 months. exclusion criteria: * central nervous system metastases; * serious or uncontrolled concurrent medical illness; * history of other malignancies; * having been enrolled in some other clinal trials within a month;

Keywords: breast neoplasm neoplasm metastasis drug therapy
orthopurext multiligament pmcf study

Conditions: Multiligament Knee Injuries

Summary: to monitor residual risks in the post-market phase and to ensure continued clinical evaluation of the device safety and performance to ensure that no new or unexpected risks arise when used during multi-ligament knee reconstructions.

orthopurext is an acellular, sterile, single use, xenograft (porcine) tissue scaffold that is manufactured using a proprietary decellularisation technology that renders the tissue substantially free from cells, leaving the porcine tissue biocompatible, and safe for implantation into the knee. 28 patients in total to be evenly distributed across potential ligament reconstruction treatment options (n=7 per sub-group) and resulting in a statistically relevant number per sub-group considering potential loss to follow up. sub-groups of n=7 incurring ligament reconstruction using orthopure xt in the following anatomical locations: * posterior cruciate ligament (pcl) * anterior cruciate ligament (acl) * posteromedial corner including the medial collateral ligament (mcl) * posterolateral corner including the lateral collateral ligament (lcl)

Eligibility criteria:
inclusion criteria: * male and female patients aged 18 years old or above. * adults suffering with multiple knee ligament injuries. * ability to communicate meaningfully with investigative staff, competence to give written informed consent; and willingness and ability to comply with entire study procedures including rehabilitation protocol. exclusion criteria: * those unable to give consent. * those considered as conflicting variables by the investigator. this may include, but is not limited to: * open trauma * neurovascular emergencies * compartment syndrome * life threatening injury * those considered as physical barriers by the investigator, preventing physical or ethical collection of study data. this may include, but is not limited to: * associated fractures that require external fixators * local severe concomitant injuries * injuries to other parts of the body associated with a high level of daily activity/intervention for the patient * those considered as a poor candidate for surgery by the investigator. * if female and of child-bearing potential must not have a positive pregnancy test at visit 1 nor have a stated intention to become pregnant in the next 12 months. * those patients contraindicated for in the ifu, i.e.: * showing signs of infection within 24 hours prior to surgery * patients with known allergy, hypersensitivity, or religious objection to, implanted porcine material * patients unable or unwilling to follow the post-operative care and rehabilitation programme

Keywords: mlki pmcf acl pcl mcl lcl ikdc koos lysholm xenograft mlkis knee reconstruction knee injuries
effect of a new infant cereal on weight gain

Conditions: Infant Development

Summary: the purpose of this study is to determine whether a new infant cereal has an effect on weight gain and intestinal microbiota compared to a standard cereal in healthy infants .

this is a multicenter, controlled, randomized, prospective, parallel-group, double-blind study to evaluate the effect of a new infant cereal supplemented with prebiotics, probiotics, vegetable proteins and a special blend of starches on weight gain and intestinal microbiota in healthy infants from 6 to 12 moths of age. patients will be randomized to receive either the new infant cereal or a standard cereal.

Eligibility criteria:
inclusion criteria: * lactating babies * 6 months of age * informed consent signed by parents exclusion criteria: * malformations, diseases or conditions that may alter development and/or nutritional status * born very and extremely preterm (\<32 weeks of gestational age)

Keywords: cereals obesity complementary feeding