Kornimate/medical-research-clean huggingface dataset:
study of isb 2001 in relapsed/refractory multiple myeloma (trignite-1)

Conditions: Relapsed/Refractory Multiple Myeloma

Summary: this study is a first-in-human, phase 1, open-label study that will evaluate safety and anti-myeloma activity of isb 2001 in participants with relapsed/refractory multiple myeloma (r/r mm).

the study will enroll participants with r/r mm that have been treated with immunomodulatory drugs (imids), proteasome inhibitors, and anti-cd38 therapies either in combination or as a single agent and are refractory to, or intolerant of, established therapies known to provide clinical benefit in mm. the study will be conducted in two parts: * part 1: dose escalation * part 2: dose expansion dose escalation will continue until either the maximum tolerated dose (mtd) is defined, the maximum planned dose is reached, or a recommended phase 2 dose (rp2d) is selected. dose expansion cohorts will be initiated to further confirm safety and optimal biologically active dose. participants will receive isb 2001 until disease progression, unacceptable toxicity occurs, any criterion for stopping the study treatment, or participant withdrawal from the study.

Eligibility criteria:
inclusion criteria: 1. participants with pathologically confirmed mm with measurable m-protein: serum and/or 24 hour urine, serum-free light chains or measurable isolated plasmacytoma 2. have an eastern cooperative oncology group (ecog) performance status score of 2 or less 3. must have adequate hematologic, hepatic, renal, and cardiac functions exclusion criteria: 1. active malignant central nervous system involvement 2. uncontrolled infection requiring systemic antibiotic therapy or other serious infection prior to c1d1 3. history of autoimmune disease requiring systemic immunosuppressive therapy 4. any concurrent or uncontrolled medical, comorbid, psychiatric or social condition that would limit compliance with study procedures, interfere with the study results, substantially increase the risk of aes, compromise ability to provide written informed consent or, in the opinion of the investigator, constitute a hazard for participating in this study. 5. female subjects who are lactating and breastfeeding or have a positive pregnancy test during the screening period or on day 1 before first dose of isb 2001.

Keywords: isb 2001 relapsed/refractory multiple myeloma open-label dose escalation dose expansion
heat stress and physiological strain of permeable vs. impermeable cb protective garment

Conditions: Heat Tolerance

Summary: current protective clothing of any kind, especially the nuclear-biological-chemical (nbc) protective garments, amplify thermal stress because of the inherent properties of the clothing material. high insulation coefficient and low water vapor permeability of the protective cloth limit the ability of sweat to readily evaporate, which consequently result with a significant elevation of body temperature and with excessive body fluid loss (because of inefficient sweating) that might result with significant dehydration. combat soldiers require to perform intense physical activities under hostile environmental conditions, including in contaminated areas that need the use of protective garments. the ability to fulfill a mission derives from the soldier's professionalism and from his physiological limits. it is well established that wearing protective garments affect tolerance time (tt) and performance. to operate in contaminated areas suitable protective garments should be worn. the inherent characteristics of the current protective garments limit, however, the effective working periods with such an ensemble, which is further aggravated in hot climate. thus, in an attempt to increase tt and enhance work effectiveness, improved protective garments, which result with a lessened heat-stress, are under different stages of development. the relative influence of air permeability properties, garment weight and garment construction on heat stress and physiological strain will be investigated. the results will be quantified in terms of body temperatures, heart rate, fluid balance, subjective sensation and the maximum wear time (if necessary extrapolated).


Eligibility criteria:
inclusion criteria: * twelve young (20-30 yr) male subjects will voluntarily participate in this study. the potential participants will be informed of the study's nature, purpose and medical risks. their inclusion in the study requires the medical clearance by the study's physician (crf) and after having filled out and sign an informed consent form exclusion criteria: * heart conditions, blood pressure higher than 140/90 mmhg, known diabetes or any skin illness or lesions. also be excluded are potential participants who were ill during the 2 weeks prior to the study
timing of bridge plate removal and distal radius fracture outcomes

Conditions: Distal Radius Fracture

Summary: the purpose of this randomized control trial will be to determine whether the duration of bridge plate fixation of distal radius fractures can be reduced to 6-8 weeks without worsening of functional outcomes relative to the current standard of greater than 12 weeks of fixation. the secondary aim of the study is to determine whether a reduced duration of bridge plate fixation leads to an increase in wrist range of motion following plate removal compared to the standard duration of fixation. 100 patients with comminuted distal radius fractures that are indicated for bridge plate fixation will be randomized to the accelerated removal arm (n = 50) or the standard removal arm (n = 50).


Eligibility criteria:
inclusion criteria: 1. fracture of the distal radius indicated for operative treatment using bridge plate fixation 2. age 18 years or greater 3. capacity to provide informed consent exclusion criteria: 1. bridge plate fixation in the setting of revision surgery for prior nonunion or malunion 2. bilateral distal radius fractures (prevents accurate measurement of postoperative range of motion and strength of the injured extremity without a normal contralateral extremity for comparison) 3. pathologic fractures 4. patients that will be unable to complete the necessary follow up, including incarcerated patients

Keywords: fracture of lower end of radius
safety and pk study of cc-90003 in relapsed/refractory solid tumors

Conditions: Neoplasm Metastasis

Summary: the cc-90003-st -001 trial is a first-in-man, open-label study in subjects with locally-advanced or wide spread cancers to determine if cc-90003 (an oral medication) can be adequately tolerated with minimal side effects.

cc-90003-st -001 is an open-label, multicenter, phase 1a study in subjects with locally-advanced or metastatic, solid tumors who are intolerant of, resistant to, or have relapsed after at least one line of therapy and for whom no standard therapy exists. the study will be conducted in two parts: dose escalation (part 1) and cohort expansion (part 2). subjects may continue cc-90003 until progression of their underlying malignancy, the occurrence of intolerable toxicity, or physician/subject decision to discontinue cc-90003. in part 1, cohorts of subjects with relapsed or refractory solid tumors will receive increasing doses of cc-90003 in order to assess its safety and tolerability, the maximum tolerated dose (mtd), and pk profile. in part 2, cohorts of subjects with specific tumors that harbor mutations involving the mitogen -activated protein kinase (mapk) pathway will receive cc-90003 at or below the mtd until progression of disease, intolerable toxicity, or physician/subject decision to discontinue cc-90003.

Eligibility criteria:
inclusion criteria: 1. eligible study subjects in part 1 and part 2 must be 18 years or older 2. eligible study subjects must have histologic or cytologic confirmation of advanced, unresectable or metastatic solid tumors, and have at least one measurable lesion per response evaluation criteria in solid tumors (recist) version 1.1 3. eligible study subjects must have eastern cooperative oncology group performance status (ecog ps) of 0 or 1 4. eligible study subjects must exhibit acceptable liver, bone marrow, renal and cardiac functions as assessed by laboratory tests, ecg and echo or muga scan. exclusion criteria: 1. subjects with symptomatic or unstable cns metastases 2. subjects with a history of recent (within 28 days) systemic therapy for their underlying malignancy 3. subjects who have had surgery/radiotherapy within 2 weeks prior to start of study

Keywords: maximum tolerated dose solid tumors locally advanced tumors metastatic solid tumors relapsed or refractory, brafv600 or ras-mutated solid tumors melanoma colorectal carcinomas papillary thyroid carcinomas pancreatic ductal adenocarcinomas non -small cell lung cancer [nsclc]
neuropsychiatric and cardiovascular side effects in ketamine analgesic infusions

Conditions: Pain, Postoperative; Ketamine Adverse Reaction

Summary: evaluation of neuropsychiatric and cardiovascular side effects of low dose ketamine analgesic infusion for postoperative pain

postoperative pain is a world wide problem related with surgery. multimodal analgesia may include ketamine, aimed to decrease opioid adverse effects in postoperative analgesia for major surgery, and risk of chronic postsurgical pain. ketamine has shown efficacy as adjuvant in multimodal analgesia, however, neuropsychiatric and cardiovascular effects of ketamine at low doses in continue postoperative infusion are less known. this type of adverse effects may compromise appropriated recovery. objective to determine frequency of delirium, agitation, sedation, hallucinations, bad dreams and cardiovascular changes associated with ketamine analgesic infusion treatment for postoperative pain.

Eligibility criteria:
inclusion criteria: - patient scheduled for abdominal, thoracic or orthopedic surgery exclusion criteria: cognitive disfunction psychiatric illness cardiovascular disease
transversus abdominis and transversalis fascia plane block combination for cesarean section

Conditions: Ceserean Section and Postoperative Pain

Summary: cesarean delivery rates are rising globally, and effective postoperative analgesia is crucial for maternal recovery and newborn care. while intrathecal morphine offers strong analgesia, it may cause side effects such as nausea, pruritus, or respiratory depression. the transversus abdominis plane (tap) block provides somatic pain relief but is often insufficient alone. the transversalis fascia plane block (tfpb) has been shown to enhance lower abdominal analgesia. this study aims to evaluate whether combining tap and tfp blocks can provide analgesic efficacy comparable to intrathecal morphine in cesarean section patients who are unable to receive opioids or are at high risk of side effects.


Eligibility criteria:
inclusion criteria: * 18-45 years old * american society of anesthesiologists physical score i or ii * caesarean section with a pfannenstiel incision exclusion criteria: * additional surgical intervention, or received general anaesthesia, * hypersensitivity to the agents to be used * bmi greater than 35 kg m-2 * coagulopathy, * local infection, * opioid addiction, * pregnancy-related hypertension * diabetes mellitus

Keywords: postoperative recovery cesarean section postoperative pain transversalis fascia plane block transversus abdominis plane block intrathecal opioid obsqor-10 t
postoperative concurrent chemoradiation for head and neck cancer with multiple minor risk

Conditions: Head and Neck Neoplasms; Carcinoma, Squamous Cell

Summary: the purpose of this study is to determine the treatment outcome of postoperative concurrent chemoradiation for head and neck squamous cell carcinoma with multiple minor risks.

currently, postoperative chemoradiation is recommended for head and neck squamous cell carcinoma with some poor prognostic feature, such as extracapsular spread of metastatic lymph node, or positive resection margin. other patients may receive postoperative radiotherapy only, if they have other risk factors. in our previous study, if there are 3 or more "minor" risk factors, the 3-year recurrence rate was 55%. this outcome was far inferior to patients who had minor risk factors less than 3. thus, we believe that current postoperative radiotherapy is insufficient for patients with multiple minor risks. a clinical trial should be raised to help these patients. however, the patient number of this group is not enough for large scale, phase 3 trial. so we arranged this phase ii trial of postoperative chemoradiation to test and prospectively observe the treatment outcome.

Eligibility criteria:
inclusion criteria: * primary squamous cell carcinoma of head and neck, after tumor excision and neck dissection, pathology has confirmed three or more of the following adverse prognostic factors, including: 1. marginale surgery but a safe distance from the residual tumor ≦ 4mm. 2. the tumor is located in the hard palate or the retromolar region. 3. poorly differentiated cell type. 4. tumor invasion to the nerve. 5. tumor invasion to lymphatic vessels. 6. tumor invasion to the small blood vessels. 7. tumor invasion to the bone. 8. tumor invasion to the skin. 9. depth of tumor invasion ≧ 10mm. 10. occurred in single lymph node metastasis. exclusion criteria: * no or presence of adverse prognostic factor but less than 2. * presence of either one conditions listed here: positive resection margin, resection margin negative but less than 1 mm, pathologic n2 or n2, or presence of nodal metastasis with extracapsular spreading. * ecog performance status \> 2. * previous cancer history (except basal cell or squamous cell skin cancer) or other synchronous malignant disease. * women during pregnancy.

Keywords: head and neck neoplasms chemotherapy radiotherapy, adjuvant surgery
massage and electroacupuncture in chronic lumbar pain

Conditions: Back Pain; Lumbar; Anesthesia, Local; Epidural; Electroacupuncture; Massage

Summary: the aim of this study is to evaluate and compare in patients with chronic back pain two therapeutic interventions: a) the combination of massage and electroacupuncture; and b) the application of epidural analgesia in pain, functioning-incompetence, quality of life and mood.


Eligibility criteria:
inclusion criteria: * patients suffering from lumbar pain of benign etiology * age 20 to 65 years exclusion criteria: * ages over 65 or below 20 years * neoplasms (benign or malignant etiology) * contagious or infectious disease * dermopathy * pregnancy * alcohol or drug use * previous use of epidural analgesia * systemic opioid use * severe heart disease * fever for more than one sessions * allergy to the oil which will be used and its derivatives * thrombi or varicose veins * psychiatric disease
effect of hydroxyurea as treatment for primary desmoid tumors

Conditions: Desmoid Tumors; Fibromatosis

Summary: the purpose of this study is to examine the response rate of desmoid tumors to hydroxyurea. the investigators hypothesize that hydroxyurea will be a safe, non-toxic alternative to aggressive surgery or chemotherapy for this difficult to treat tumor.

the treatment of desmoid tumors is complicated by benign histology and potentially aggressive and recurrent behavior. invasive or intensive treatments with surgery or radiation therapy can lead to good tumor control, but at the expense of significant side effects along with a high risk of local recurrence after surgical excision. low dose regimens of standard chemotherapy drugs have been favored as a conservative first-line treatment; however, refractory and recurrent tumors are not uncommon. the purpose of this study is to investigate the efficacy and safety of using hydroxyurea, an anti-neoplastic agent with relatively few side-effects, as a novel treatment for primary, unresectable desmoid tumors, desmoid tumors that have had an incomplete primary resection, or desmoid tumors that have recurred after other therapy. patients presenting to our oncology center with a new diagnosis of desmoid tumor, or a recurrent desmoid tumor, will be eligible for this study. after informed consent, physical examination, and baseline imaging studies (ct/mri), patients will receive oral hydroxyurea at a starting dose of 20 mg/kg daily. laboratory tests will be performed at set intervals to maintain the appropriate dose and monitor for cytopenias. clinical evaluations, physical examinations, and/or imaging studies will be conducted every three months to assess for changes in tumor size. patients will remain on hydroxyurea as long as there is a response or stability in tumor size and associated toxicities are manageable. data will be collected regarding the response to the drug, the duration of the response, and the occurrence of adverse events. the goal of the analysis will be to determine the efficacy of hydroxyurea as a treatment modality for desmoid tumors.

Eligibility criteria:
inclusion criteria: * patients \</= 21 years of age will be eligible * histologically-confirmed diagnosis of desmoid tumor * measurable disease * stable hematologic, renal and hepatic parameters * negative pregnancy test for women of childbearing potential exclusion criteria: * presence of a second neoplastic process * pregnant or breastfeeding women, fetuses, and prisoners will not be included in this study * patients receiving additional treatment for tumor other than pain control * patients having taken an investigational drug within the past 30 days
effect of pyridostigmine (mestinon) on muscle strength in myasthenia gravis

Conditions: Myasthenia Gravis

Summary: a randomized, placebo-controlled, double-blinded cross-over study evaluating and quantifying the effect of pyridostigmine on muscle strength and symptoms in myasthenia gravis (mg)

the study aims to evaluate and quantify the effect of pyridostigmine on symptoms and muscle strength in newly-diagnosed patients and patients on stable medication. pyridostigmine treatment is initiated in the vast majority of mg patients. no studies have quantified the effect in a randomized trial, and no studies have examined the potential difference in effect in newly diagnosed patients as compared to patients on stable, antimyasthenic medications. the study will investigate the effect in two groups 1. newly diagnosed, treatment-naive patients. 2. mg patients on stable antimyasthenic medication.

Eligibility criteria:
inclusion criteria: * mg verified by a) anti-body, or b) single-fiber emg and/or decrement on eng. exclusion criteria: * anti-musk * known cardio-pulmonary disease * known neuropathy * known myopathy * known malignant disease * pregnancy or breastfeeding * mechanic ileus, urinary tract obstruction, peritonitis de-novo mg eligibility criteria * mg diagnosis \< 2 months, no prior antimyasthenic medications chronic mg eligibility criteria * mg diagnosis \> 1 year, and stable pyridostigmine dosis
near infrared fluorescence using indocyanine green and magnetic resonance lymphography of lymphatic transport

Conditions: Rheumatoid Arthritis

Summary: lymphatic transport will be examined using near infrared indocyanine green fluorescence imaging (nir-icg) and magnetic resonance lymphography (mrl) of the upper extremities. the purpose of the study is to establish if nir-icg is a valid clinical outcome for quantifying lymphatic vessel drainage.

lymphedema from various etiologies (i.e. infection, cancer, surgery, and rheumatoid arthritis) remains a major health concern. efforts to develop effective treatments for this condition have been limited by the absence of quantitative outcome measures for lymphatic function. published articles have supported the fact that human lymphatic contractions can be readily visualized after intradermal administration of micrograms of indocyanine green using laser-induced fluorescence. we recently demonstrated the feasibility of nir imaging to quantify lymphatic drainage in the hands, wrists and forearms of healthy volunteers following intradermal web space icg injection into the hand . to establish this emerging technology as a valid clinical outcome measure, however, we must address two major questions that confound interpretation of the imaging results: 1) are the icg filled vessels lymphatic vessels and/or small veins?; and 2) does nir-icg imaging following web space injection fully capture lymphatic flow from the metacarpophalangeal (mcp) joints that are most commonly involved in ra? to answer these questions, healthy patients will be recruited to have intradermal and intra-articular injections of icg and gadolinium followed by an imaging sessions (nir or magnetic resonance imaging) to measure lymphatic contraction rates and flow.

Eligibility criteria:
inclusion criteria: * ability to provide written informed consent. * subjects must be 18 years old or older. exclusion criteria: * active systemic disorders or inflammatory conditions (i.e., chronic infections with hepatitis b, hepatitis c or hiv) that would confound the study results. * known sensitivity to iodine because of residual iodide in indocyanine green * known sensitivity to gadolinium * any history of kidney disease * pregnant women should not participate; pregnancy tests will not be performed.

Keywords: healthy volunteers lymphatic transport imaging indocyanine green gadolinium icg gad nir-icg rhuematoid arthritis nir
acute and chronic effects of saxagliptin

Conditions: Impaired Glucose Tolerance

Summary: glucose acces study will explore the acute and long term (12-week treatment) effects of saxagliptin in patients with impaired glucose tolerance during fasting and after a standardised breakfast. the investigations will be performed on: * glycemic parameters * on cardiovascular parameters

the aim of this pilot study is to compare in patients with impaired glucose tolerance the effects of saxagliptin versus placebo: (i) on glucose metabolism (ii) on vago-sympathetic activity, arterial stiffness and endothelial function. a total of 36 patients will be recruited in the department of endocrinology-diabetology-nutrition of jean verdier hospital, ap-hp, bondy, france. the measurements will be performed in the morning 1) at the time of randomisation (acute acces study) and 2) 11-14 weeks after the beginning of saxagliptin or placebo (chronic acces study). we will evaluate at fasting and each hour after a standardized breakfast: (i) biological and metabolic parameters. furthermore, an oral glucose tolerance test will be performed at the end of the study. (ii) by non-invasive devices arterial stiffness (sphygmocor®), endothelial function (endopat 2000® ), cutaneous microcirculation (laser doppler perimed ®.pf 5010) and cardiac autonomic function(task force monitor®).

Eligibility criteria:
inclusion criteria: * social security affiliation * persons without tutorship that can freely agree to participate to the study * age between 18 to 70 years * impaired glucose tolerance diagnosed during the previous month. exclusion criteria: * pregnancy * breast feeding * diabetes * no contraception * body mass index \> 45 kg/m² * arterial blood pressure \> 160/110 mmhg * creatinine clearance \< 60 ml/min * severe hepatocellular insufficiency * chronic respiratory disease * anaemia (hemoglobin \< 10 g/dl) * peripheral arterial occlusive disease * heart failure * cardiac arrhythmia

Keywords: impaired glucose tolerance saxagliptin cardiovascular risk integrators vago-sympathetic activity arterial stiffness endothelial function