Kornimate/medical-research-clean huggingface dataset:
cell therapy for chronic traumatic cervical incomplete spinal cord injury

Conditions: Spinal Cord Injury Cervical

Summary: this is a double-blind, randomized, placebo-controlled, multicenter clinical trial in which 18 patients affected with chronic traumatic incomplete cervical spinal cord injury will be randomized to either the active treatment (2 doses of intrathecal wj-msc 3 months apart) or to placebo (2 intrathecal infusions, 3 months apart). thereafter, patients will be followed-up for 12 months for safety and efficacy assessment.

double-blind, randomized, placebo-controlled, multicenter clinical trial that will include 18 patients affected with chronic traumatic incomplete cervical spinal cord injury who will be randomized 1:1, stratified by center, to one of the 2 treatment arms of the study: wj-msc / wj-msc (at a dose of 1e6 ± 30% live cells / kg of weight) or placebo / placebo. medication will be administered intrathecally at day 1 and at 3 months. the main objective of the trial is to assess safety at a 12-month follow-up. secondary objectives include the evaluation of efficacy through clinical response, electrophysiological changes, questionnaires of functionality and quality of life, as well as the presence of anti-hla antibodies and donor cellularity in the cerebrospinal fluid.

Eligibility criteria:
inclusion criteria: 1. single spinal cord injury lesion caused by trauma 2. affected cord segments between c1 and t1, confirmed by magnetic resonance 3. incomplete lesion (asia b, c or d) 4. chronic disease state (between 1 and 5 years after the injury) 5. patients from 18 to 70 years of age, both sexes 6. life expectancy \> 2 years 7. residence near the center during study participation and confidence that the patient will attend the follow-up visits 8. given informed consent in writing 9. patient is able to understand the study and its procedures exclusion criteria: 1. mechanic ventilation 2. penetrating trauma affecting the spinal cord 3. pregnant woman or without proper anticonceptive measures according to the investigator, or breath feeding 4. planned spinal surgery within subsequent 12 month after entering the trial 5. neurodegenerative diseases 6. significant abnormal laboratory tests that contraindicates patient's participation in the study 7. neoplasia within the previous 5 years, or without complete remission 8. patient with communication difficulties 9. simultaneous participation in another clinical trial or treated with an investigational medicinal product the previous 30 days, that could interfere in the results of the study 10. previous treatment with and advanced therapy medicinal product (cell therapy) 11. contraindication for lumbar punction 12. contraindication or inability to follow a rehabilitation program 13. other pathologic conditions or circumstances that difficult participation in the study according to medical criteria 14. the patient does not accept to be followed-up for a period that could exceed the clinical trial length

Keywords: spinal cord injury mesenchymal stromal cells wharton jelly cell therapy
vitamin d supplementation and immunity/physical performance

Conditions: Vitamin D Status

Summary: the purpose of this study is to examine the effect of vitamin d supplementation on vitamin d status, immunity and physical performance.

vitamin d plays a key role in bone mineralisation and has been linked to immune defence maintenance and muscle function. vitamin d is primarily obtained from endogenous synthesis in response to skin sunlight exposure and follows a seasonal pattern; whereby, vitamin d levels peak at the end of the summer and fall to a trough during winter. if winter vitamin d levels can be increased to match those found in summer using supplementation, it is proposed sufficient vitamin d levels will improve physical performance and reduce susceptibility to illness in military recruits.

Eligibility criteria:
inclusion criteria: * passed medical assessment by medical doctor exclusion criteria: * medically deferred by medical doctor * regular sun bed use * holiday in a hot sunny climate in \<3 months * regular vitamin d supplementation

Keywords: vitamin d deficiency simulated sunlight radiation oral vitamin d3
national tunisian registry of hypertension

Conditions: Hypertension

Summary: the tunisian society of cardiology and cardiovascular surgery (stcccv) proposes to coordinate a national, observational, cross-sectional and multicenter survey carried out during one month. the main objective of the survey is to describe the blood pressure and cardiovascular risk profile of the hypertensive patient in tunisia. this survey will allow us to have a generalized and updated view of the tunisian hypertensive patient in order to optimize treatment and to know the degree of adherence of practitioners to international recommendations in the care of the hypertension in tunisia.


Eligibility criteria:
inclusion criteria: age ≥ 18 years informed consent, read and signed exclusion criteria: consent not obtained

Keywords: nature-htn
proof-of-concept study of a single application of an investigational otic suspension in treatment of acute otitis media with tympanostomy tubes

Conditions: Acute Otitis Media

Summary: the purpose of this study is to evaluate a single application of al-60371/al-817 otic suspension relative to ototopical ciprodex for sustained clinical cure, microbiological success, and time to cessation of otorrhea.

the results at the time of the interim analysis met the futility criteria and the study was subsequently stopped.

Eligibility criteria:
inclusion criteria: * parent or guardian: read and sign the informed consent. when required by the institutional review board, child must agree to sign an approved assent form; * presence of otorrhea (visible by parent or guardian) of 21 days or less in duration; * presence of patent tympanostomy tubes; * refrain from water immersion of the ears following surgery without the use of adequate ear protection during swimming, bathing, showering and other water-related activities; * parent or guardian: agree to comply with the requirements of the study, administer the study medication as directed, complete required study visits, and comply with the protocol; * other protocol-defined inclusion criteria may apply. exclusion criteria: * not otorrhea-free for at least seven days following tympanostomy tube surgery; * menarcheal females; * previous otologic surgery, except tympanic membrane, within one year of study entry; * history of/or current acute or chronic non-tube otorrhea (through existing perforation of the eardrum); * current acute otitis externa, malignant otitis externa, or other conditions which could interfere with evaluation of the study drug; * diabetic (controlled or uncontrolled); * use of prohibited medications; * other protocol-defined exclusion criteria may apply.

Keywords: aomt tympanostomy tubes otorrhea anti-infective
exercise enhancement after radiotherapy for bone metastases

Conditions: Bone Metastases

Summary: the purpose of this study is to evaluate the safety, feasibility, and acceptability of a structured, supervised exercise program combined with standard palliative radiotherapy for patients with painful non-spine bone metastases (nsbm).

this study investigates the potential benefits of exercise therapy for patients with bone metastases, a common and often painful complication of cancer. the study aims to determine whether a structured exercise program, in combination with standard of care cancer treatment, can improve physical function, quality of life, and overall well-being for patients undergoing palliative radiotherapy. participants will complete a 8-week supervised exercise program that is tailored to their individual needs and abilities. the exercises, guided by certified professionals, will focus on improving strength, flexibility, and mobility. participants will also receive educational sessions covering various aspects of self-management and coping strategies. the study monitor the safety and feasibility of the exercise program, as well as its impact on pain levels, functional abilities, and quality of life. follow-up assessments will occur at 1, 3, and 6 months post-intervention to track progress and gather valuable insights into the potential benefits of exercise therapy for individuals with bone metastases. by exploring the role of exercise in cancer care, this study seeks to empower patients with new tools to manage their symptoms, enhance their well-being, and improve their overall quality of life throughout their cancer journey.

Eligibility criteria:
inclusion criteria: * age 18 or older. * kps ≥70 * histologically confirmed cancer and radiologically documented nsbm metastases. spine metastases are allowed if they do not meet the exclusion criteria below. * at least one painful nsbm treated with palliative radiotherapy. * independent with ambulation and transfers. ambulatory aids are permitted. * life expectancy of at least 6 months exclusion criteria: * any untreated metastatic disease that may preclude safely performing physical exercise including: * history of leptomeningeal disease * active (untreated/progressive) malignant spinal cord or cauda equina compression * bilsky 2 or 3 * neurological compromise secondary to cns involvement * symptomatic brain metastases prohibiting exercise due to neurological compromise * high risk of instability of any boney lesion(s) that may require orthopedic intervention * sins score \> 7 * mirels score \> 6
botox® treatment for adults with a wide lower face due to masseter muscle prominence

Conditions: Masseter Muscle Prominence

Summary: this study is designed to evaluate the safety and effectiveness of administering botox for the treatment of masseter muscle prominence (mmp) in adults.


Eligibility criteria:
inclusion criteria: inclusion criteria: * masseter prominence at the day 1 visit * bmi ≤ 30 kg/m2 using the calculation: bmi = weight (kg)/\[height (m)\]2 * a female participant must be willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up periods exclusion criteria: * any medical condition that may put the participant at increased medical risk with exposure to botox, including diagnosed myasthenia gravis, eaton-lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function * an anticipated need for surgery or overnight hospitalization during the study * an anticipated need for treatment with botulinum toxin of any serotype for any indication during the study (other than study intervention) * history of dental or surgical procedure for lower facial shaping or masseter muscle reduction * prior mid-facial and/or lower facial treatment with nonpermanent soft tissue fillers, synthetic implantations, autologous fat transplantation, fat-reducing injectables, and/or skin-tightening laser treatments within 6 months prior to day 1 * prior exposure to botulinum toxin of any serotype to the masseter muscle or lower face at any time, or to any other part of the body within the 6 months prior to day 1 * history of temporomandibular joint disorder (tmjd) * masseter prominence due to other etiologies (eg, parotid gland infection, parotiditis, malignancy) * known allergy or sensitivity to any of the components of the study treatments or any materials used in the study procedures * history of alcohol or drug abuse within 12 months of day 1
combination chemotherapy in treating patients with stage iii or stage iv pancreatic cancer that cannot be removed by surgery

Conditions: Pancreatic Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. combining more than one drug may kill more tumor cells. purpose: phase ii trial to study the effectiveness of combination chemotherapy in treating adult patients who have stage iii or stage iv pancreatic cancer that cannot be removed by surgery.

objectives: i. determine the overall survival in patients with unresectable stage iii or iv pancreatic adenocarcinoma treated with gemcitabine, cisplatin, and fluorouracil. ii. determine the resectability rate with curative intent in patients with unresectable stage iii pancreatic adenocarcinoma treated with this regimen. iii. assess the tolerability and toxicity of this treatment regimen in this patient population. iv. evaluate this regimen in terms of response rate, response duration, and overall time to disease progression in these patients. v. evaluate the quality of life in these patients. outline: patients receive gemcitabine iv over 30 minutes on days 1, 8, and 15, followed by cisplatin iv over 30 minutes on days 1 and 15. patients receive fluorouracil as a continuous infusion on days 1-15. courses repeat every 28 days. quality of life is assessed every 28 days. projected accrual: a total of 30 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: histologically or cytologically confirmed pancreatic adenocarcinoma unresectable locally advanced (stage iii) or metastatic (stage iv) gallbladder or biliary tract cancer allowed no endocrine tumors or lymphoma of the pancreas no cns metastases patient characteristics: age: adult performance status: swog 0-2 life expectancy: at least 12 weeks hematopoietic: absolute neutrophil count greater than 1,500/mm3 platelet count greater than 100,000/mm3 hepatic: bilirubin no greater than 2.0 mg/dl ast no greater than 3.0 times upper limit of normal renal: creatinine no greater than 1.5 mg/dl other: no active infection no other serious systemic disorders no other active malignancies within the past year except curatively treated basal cell skin cancer or carcinoma in situ of the cervix must have central venous access device (i.e., infusaport or pasport) not pregnant or nursing fertile patients must use effective contraception prior concurrent therapy: biologic therapy: not specified chemotherapy: no prior chemotherapy for locally advanced or metastatic disease at least 6 months since prior adjuvant chemotherapy no prior gemcitabine endocrine therapy: not specified radiotherapy: not specified surgery: see disease characteristics

Keywords: stage iii pancreatic cancer recurrent pancreatic cancer stage iv pancreatic cancer
treatment of patients with stage iii non-small cell lung cancer in russia"

Conditions: Stage III Non-small Cell Lung Cancer

Summary: in connection with the transition to the 8th version of the classification of lung cancer according to the tnm system, there are currently no precise epidemiological data on stage iii nsclc, clinical characteristics of patients in this group, approaches to therapy and treatment results in the russian federation. the published statistics only provide information on the overall incidence of stage iii lung, trachea and bronchial cancer, which is about 40%. this observational study will make it possible to characterize the russian population of stage iii non-small cell lung cancer patients, approaches to choosing a treatment option for stage iii nsclc and the outcomes of this treatment in real clinical practice.


Eligibility criteria:
inclusion criteria: - stage iii non-small cell lung cancer exclusion criteria: - the rest of the disease stage

Keywords: non-small cell lung cancer
electroacupuncture versus fast-track perioperative program for laparoscopic colorectal surgery

Conditions: Postoperative Ileus

Summary: background: our previous study demonstrated that electroacupuncture at zusanli, sanyinjiao, hegu, and zhigou reduces the duration of postoperative ileus and hospital stay after laparoscopic colorectal surgery within a traditional perioperative care setting. recent evidence also suggested that a 'fast-track' perioperative program may help accelerate recovery after colorectal surgery. as electroacupuncture is simpler to implement and less labor intensive, it may be the preferred adjunct therapy if it is proven to be noninferior to fast-track program in reducing the duration of postoperative ileus and hospital stay after laparoscopic colorectal surgery. objectives: to compare the efficacy of electroacupuncture and fast-track program in reducing the duration of postoperative ileus and hospital stay after laparoscopic colorectal surgery. design: prospective, randomized, noninferiority trial. subjects: one hundred sixty-four consecutive patients undergoing elective laparoscopic resection of colonic and upper rectal cancer will be recruited. interventions: patients will be randomly allocated to receive either: (a) electroacupuncture with traditional perioperative care; or (b) fast-track program without acupuncture. outcome measures: primary outcome: time to defecation. secondary outcomes: duration of hospital stay, time of first passing flatus, time to resume diet, pain scores, analgesic requirement, morbidity, and medical costs. conclusions: this study will determine if electroacupuncture is noninferior to fast-track program in reducing the duration of postoperative ileus and hospital stay after laparoscopic colorectal surgery. electroacupuncture may be the preferred perioperative adjunct therapy to laparoscopic colorectal surgery because it is simpler to implement and less labor intensive than fast-track program.


Eligibility criteria:
inclusion criteria: * consecutive patients undergoing elective laparoscopic resection of colonic and upper rectal cancer * age of patients between 18 and 80 years * patients with american society of anesthesiologists (asa) grading i-ii * patients with no severe physical disability * patients who require no assistance with the activities of daily living * informed consent available exclusion criteria: * patients undergoing laparoscopic low anterior resection with total mesorectal excision, abdominoperineal resection, or total/proctocolectomy * patients with planned stoma creation * patients undergoing emergency surgery * patients with evidence of peritoneal carcinomatosis * patients with previous history of midline laparotomy * patients who are expected to receive epidural opioids for postoperative pain management * patients with cardiac pacemaker * patients who are allergic to the acupuncture needles

Keywords: electroacupuncture fast track program postoperative ileus laparoscopic surgery colorectal surgery randomized controlled trial hospital stay
family welfare pilot intervention study

Conditions: Obesity

Summary: the purpose of this study was to test internet and mobile-based applications to support motivating lifestyle counseling to promote healthy eating habits of the mothers and their spouses expecting first child. the feasibility of the intervention will be evaluated in the pilot.

lifestyle habits during pregnancy have long-term effects of baby's as well as mother's health. pregnancy period is a favorable time for lifestyle changes, as the parents usually have motivation and assets to change lifestyle. maternity welfare clinic is the place to promote healthy lifestyles because most finnish families expecting child visit there at regular intervals.

Eligibility criteria:
inclusion criteria: * all families expecting their child at their standard 8-10 pregnancy weeks welfare clinic visit exclusion criteria: * parents are under 18-year-old * parents do not speak finnish * parents do not have internet access
axitinib therapy management study

Conditions: Renal Cell Carcinoma

Summary: the objectives of the study is to describe axitinib therapy management through use of the data to be generated by concertai

not mandatory

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of arcc (stage iii, stage iv (m0) or stage iv (m1)) at any point * age 18 years or older at the time of arcc diagnosis * received a qualifying io-containing combination (nivolumab and ipilimumab, axitinib and pembrolizumab, or axitinib and avelumab) in the first regimen after arcc diagnosis or axitinib monotherapy in any line exclusion criteria: * none
investigation of standard excision surgical margins using two photon fluorescence microscopy

Conditions: Basal Cell Carcinoma

Summary: the goal of this clinical trial is to compare the use of two photon fluorescence microscopy for detecting residual basal cell carcinoma during standard local excision.

this study is an study of skin cancer that will evaluate the feasibility of two photon fluorescence microscopy (tpfm) to evaluate surgical margins followed by standard of care permanent sections for final margin confirmation. to protect patients, following tpfm imaging, patients will receive standard of care evaluation on permanent sections, thus all patients will receive standard of care confirmation following experimental imaging. individual excisions from consenting patients will be selected, fluorescently labeled and the distance to inked margins measured with tpfm. following imaging, specimens will be submitted for paraffin processing as per normal procedure and the resulting slides scanned. the distance to the inked margin will be measured on the permanent sections and compared to tpfm to determine accuracy.

Eligibility criteria:
inclusion criteria: * undergoing treatment for basal cell carcinoma without mohs surgery at the performance site * able to read and understand consent form exclusion criteria: * none
the effect of growth hormone releasing hormone on cognitive function in individuals with mild cognitive impairment

Conditions: Mild Cognitive Impairment

Summary: this study is examining the effects of growth hormone releasing hormone (ghrh) on mild cognitive impairment (mci). ghrh will be given at a dose of 1mg/day for 10 weeks to subjects with mci as well as healthy controls.

subjects with mci as well as healthy controls will be given ghrh at a dose of 1mg/day for 10 weeks. this study is designed to investigate the effects of ghrh on the following things: 1) cognitive function as measured by our neuropsychologist with a series of short tests; 2) brain activity as measured by fmri 3) lean and fat mass of your body as measured by dexa; 4) physical function as measured by a walking test.

Eligibility criteria:
inclusion criteria: * age ≥ 55 to ≤ 85 years * ability to sign consent form (score ≥ on the mini mental state examination, mmse) * mci group: mmse scores of 23 - 26 * normal control group: mmse scores of 27 - 30 exclusion criteria: * diabetes * a neurologic condition other than mci which might cause cognitive impairment * baseline serum igf-1 concentration greater than the midrange for healthy young adults (300ng/ml) * presence of a pacemaker or metal implant * heart failure * edema * active malignancy * carpal tunnel syndrome * disruption of the hypothalamic pituitary axis such that the pituitary is expected to be insensitive to growth hormone secretagogues such as ghrh * known allergy to tesamorelin or mannitol * pregnancy * significant heart, liver, kidney, blood or respiratory disease * active cancer * recent (within 6 months) treatment with anabolic steroids, ghrh or corticosteroids * alcohol or drug abuse * mmse \< 23 * less than 12 years of education * significant findings on screening tests, including but not limited to, blood counts, blood biochemistries, urinalysis, drug screening, hiv test, hepatitis panel, electrocardiogram * other medical conditions deemed exclusionary by the study investigators