Kornimate/medical-research-clean huggingface dataset:
tumor bed hypofractionated imrt after surgery for patients with single,large brain metastases from solid tumor

Conditions: Brain Metastases

Summary: investigators designed a study of a multimodality approach: surgery followed by hypofractionated intensity modulated radiation therapy (imrt) using vmat approach for patients with single, large brain metastases from solid primary tumor

investigators designed a study to recruit patients with single, large brain metastases from solid primary tumor for a multimodality approach: surgery followed by hypofractionated intensity modulated radiation therapy (imrt) using vmat approach. the potential advantage of this treatment is to improve local control and to reduce toxicity compared with wbrt or srs after surgical resection.

Eligibility criteria:
inclusion criteria: * age \> 18 years * karnosky performance status (kps) ≥70 * all solid tumor (esclusion sclc and germinal tumors) * controlled primary tumor * controlled other metastatic site * single metastatic lesion at diagnosis * lesions ≥ 2.1 cm in maximum diameter (4 cm3), \< 3 cm conditioning mass effect or neurological deficits or massive aedema, unknown primary tumor * estimated survival ≥ 3 months. * written informed consent exclusion criteria: * prior wbrt * kps ≤ 70 * other primary cancer * pregnant women
serial changes in micturition symptoms, urine flow and bladder voiding efficiency following transobturator tape surgery

Conditions: Stress Urinary Incontinence

Summary: the aim of this study was to identify the serial changes in lower urinary tract symptoms (luts), urine flow and bladder voiding efficiency after transobturator tape (tot) surgery for treatment of female stress urinary incontinence.


Eligibility criteria:
inclusion criteria: * women who underwent transobturator tape surgery for treatment of female stress urinary incontinence exclusion criteria: * any urinary tract infection * pregnancy * bladder malignancy * postoperative follow-up of less than 12 months
feasibility trial of the early psychological support for the critically ill

Conditions: PICS

Summary: this is a pilot study designed to test feasibility of a psychotherapeutic intervention for the critically ill patients in intensive care units. intervention is named early psychological support for the critically ill (epsci)


Eligibility criteria:
critically ill adults admitted to the medical intensive care unit (icu) and expected to stay \>48 hours inclusion criteria: -mechanically ventilated patients receiving vasopressors exclusion criteria: * history of dementia * mental retardation * suicide attempt * psychotic disorders such as schizophrenia * patients on comfort care non-english speaking.
effects of sarah protocol in women with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the aim of this randomized controlled trial is to analyze the effect of the sarah protocol, which is a set of exercises with components of muscle strengthening, range of motion gain and home exercises, combined with an educational intervention, on hand function in women with rheumatoid arthritis (ra).

the volunteers will be randomized between groups: control group (n=30), which will receive usual guidelines and the sarah group (n=30), which will perform the sarah protocol exercises (brazilian portuguese version) along with the usual guidelines. to participate in the research, patients must be diagnosed with ra using disease-modifying antirheumatic medication for at least 3 months, and age equal to or older to 18 years. participants with incomplete elementary school and score \<24 on the mini-mental state examination questionnaire (mmse) will be excluded from the study. the participants will be evaluated before and after the intervention regarding the variables: hand function (michigan hand outcomes questionnaire), pain (brief pain inventory), handgrip strength (jamar® manual dynamometer), quality of life (euro quality of life instrument-5d), functional capacity (health assessment questionnaire), ra disease activity (das28). the sarah group will receive an exercise book containing 7 mobility exercises and 4 strength exercises that are performed using elastic materials that provide progressive degrees of resistance to movement. patients will be guided in person by a trained professional, so that they are carried out without their presence, in the home environment, daily and monitored at periodically scheduled meetings. a total of 4 face-to-face meetings will be held during the 3-month follow-up. the sarah group and the control group will receive information related to joint protection, use of splints, assistive devices and other general advice, as needed, will receive some booklets to reinforce the guidelines. the program will last 12 weeks, with 4 face-to-face meetings lasting 40 minutes and monitored in periodically scheduled meetings.

Eligibility criteria:
inclusion criteria: * patients must be diagnosed with ra * using disease-modifying antirheumatic medication for at least 3 months * over 18 years old exclusion criteria: * incomplete elementary school and score \<24 on the mini-mental state examination questionnaire (mmse) * diagnosis of another associated autoimmune disease * having undergone previous surgical procedures on the hands * having suffered a fracture in the joints of the upper limbs in the last six months * being a patient on the waiting list for orthopedic surgery of the upper limb * being pregnant.

Keywords: exercise hand physical therapy
sword health patient registry

Conditions: Musculoskeletal Diseases

Summary: the purpose of this study is to create a research repository, comprised of data collected in the course of physical rehabilitation programs for musculoskeletal disorders (msds) using the medical device sword phoenix®. this will allow the company to ascertain the acceptance, engagement and effectiveness of programs using this asynchronous tele-rehabilitation platform in the treatment of multiple msds.

the data that will be collected in the scope of this registry includes: 1. data that is sourced from the subject, which will be collected by the physical therapist managing that subject; 2. data that is generated by the physical therapist through interaction with the web-based portal (i.e. session composition in terms of exercises, sets, repetitions, usage or not of external resistance) 3. data that is generated by the subject through interaction with the app (i.e. pain and fatigue levels, satisfaction) 4. data that is generated automatically by the medical device (i.e. range of motion, compliance) collection and objective analysis of the collected data will allow: 1. assess the adoption, engagement and feasibility of digital care programs for musculoskeletal conditions and musculoskeletal health 2. assess the results of digital care programs and compare the costs with the benefits obtained; 3. correlate the results with patient's demographic and clinical profiles; 4. examine the impact of mental health and the behavioral modification components of sword health interventions on disease markers, comorbidities, and productivity; 5. increase the knowledge on several musculoskeletal conditions, namely how they progress and respond to digital care programs; 6. develop new or improved tools to assist clinicians in the management of these conditions and in helping people achieve better musculoskeletal health clinical outcomes the primary outcome will be the evolution of patient's clinical condition along the rehabilitation program, objectively estimated through the monitoring data collected using sword phoenix®, as part of patients' supervision routine. depending on the condition, primary and secondary outcome measures vary. in any case, this registry will include a complete characterisation of the clinical condition, as well as the periodic assessment of: a) joints' range of motion (collect by the medical device); b) performance indicators (through condition-specific tests); c) patient-reported outcomes (obtained using internationally validated pathology-specific questionnaires); d) pain and fatigue levels (reported by patients by the end of each therapeutic exercise session); e) compliance; f) patient satisfaction

Eligibility criteria:
inclusion criteria: * over 18 years old; * initiating a rehabilitation program using the medical device sword phoenix®; * able to understand study procedures and willing to provide informed consent. exclusion criteria: * none
a study to evaluate safety of exposure to wegovy during pregnancy

Conditions: Pregnancy; Obesity; Overweight

Summary: this is an observational, prospective wegovy (semaglutide 2.4 milligram \[mg\]) pregnancy registry study. the aim of this study is to compare the maternal, foetal, and infant outcomes of pregnant women who are exposed to wegovy during pregnancy for the treatment of obesity or overweight with at least one weight-related comorbid condition with outcomes in an internal comparison cohort of pregnant women with obesity or overweight with at least one weight related comorbid condition at conception and who are not exposed to wegovy or other glucagon-like peptide-1 receptor agonists (glp-1 ras) during pregnancy. infant outcomes will be assessed throughout the infant's first year of life, with active data collection by the registry occurring at 4 and 12 months after delivery.


Eligibility criteria:
inclusion criteria: * signed consent obtained before any study-related activities * female 15-50 years of age at the time of signing consent * currently or recently pregnant * resident of country included in the study * authorisation for her hcp(s) to provide data to the registry * exposed to wegovy cohort: exposure to at least one dose of wegovy at any time during pregnancy for the treatment of obesity or overweight with at least one weight-related comorbid condition. * unexposed to wegovy cohort: have obesity or overweight with at least one weight related comorbid condition at conception exclusion criteria: * mental incapacity, unwillingness, or language barriers precluding adequate understanding or cooperation * unexposed to wegovy cohort: exposure to wegovy or other glp-1 ra at any time during pregnancy
safety of org 34517 900 mg in patients who received org 34517 in a previous trial (study 28133/p05842)

Conditions: Depressive Disorders; Psychotic Disorders; Depression

Summary: patients who participated in the previous trial 28130, who were eligible, were entered into this trial. patients who were randomized to placebo in the previous trial 28130 continued on placebo while patients who were randomized to org 34517 (sch 900636), regardless of dose, were titrated to 900 mg org 34517. patients in this trial took their study medication for 2 weeks in order to study the safety and tolerability of org 34517.


Eligibility criteria:
inclusion criteria: * have attended screening, baseline, visit day 15, day 29 and day 43 of previous trial 28130; * have a cgi of severity score of 3 or greater at day 43 of previous trial 28130 and at day 1 of current trial 28133, or a lower score when the investigator is of the opinion that further resolution of symptoms is warranted; * be on a stable dose of 'usual treatment', which must consist of an antidepressant, an antipsychotic, a mood stabilizer or any combination of these 3 drug classes. exclusion criteria: * had experienced any of the following significant safety outcomes in previous trial 28130: * severe breakthrough bleeding; * diagnosis of prostatitis; * abnormal level of testosterone at day 15 of previous trial 28130; * any adverse event deemed relevant for exclusion in trial 28133 by the investigator. * had an abnormal psa test at day -7 of previous trial 28133 * were at significant risk of committing suicide, as indicated by a score greater than 9 on the revised isst at day -7 or day 1; * were currently treated with carbamazepine or valproate, midazolam, or clozapine; * had been treated with electroconvulsive therapy (ect) in the current episode; * were currently treated with more than one antidepressant, antipsychotic, or mood stabilizer; * had 'usual treatment' started or discontinued in the 2 weeks before day 1; * had a 'usual treatment' dose change within one week prior to day 1; * had any clinically unstable or uncontrollable renal, hepatic, respiratory, hematological, cardiovascular or cerebrovascular disease that would put the patient at risk of safety or bias assessment of efficacy; * had known hypersensitivity reactions to glucocorticoid antagonists; * had any clinically significant abnormal laboratory data (e.g. aspartate amino transferase (asat) and/or alanine amino transferase (alat) values \> 2x normal range upper limit) or ecg results, or a clinically significant abnormal outcome at the physical examination at day -7; * had a confirmed positive result on the drug screening test for any illicit drug, except cannabis, at day -7; * had any untreated or uncompensated clinically significant endocrine disorder; * were using hormone replacement therapy at day -7; * required concomitant treatment with corticosteroids (topical use was allowed); * women of childbearing potential without adequate contraception * women with a positive pregnancy test at day -7 or 1, or are breast feeding mothers.
a prospective, single-arm study to evaluate the efficacy and safety of zoladex 3.6mg combined with cef chemotherapy as neo-adjuvant therapy in hormone responsive, premenopausal, operable breast cancer

Conditions: Breast Cancer

Summary: it has been found that many breast cancers are hormone dependent and that hormonal therapy by estrogen suppression such as ovarian ablation, tamoxifen and aromatase inhibitor has proven beneficial in both adjuvant and neoadjuvant settings. zoladex, a kind of luitinizing hormone releasing hormone analogue, can offer efficient estrogen suppression as well. it can induce reversible amenorrhea and the clinical effect is similar to ovarian ablation. some studies have demonstrated the efficacy of zoladex in treating pre and perimenopausal hormone dependent breast cancer in both adjuvant and metastatic settings. few data is available on zoladex in neoadjuvant treatment for breast cancer in our departments, neoadjuvant cef regimen is of general practice, and a preliminary study is designed to investigate whether adding zoladex into neoadjuvant cef could further improve results in hormone responsive breast cancer.

it has been found that many breast cancers are hormone dependent and that hormonal therapy by estrogen suppression such as ovarian ablation, tamoxifen and aromatase inhibitor has proven beneficial in both adjuvant and neoadjuvant settings. zoladex, a kind of luitinizing hormone releasing hormone analogue, can offer efficient estrogen suppression as well. it can induce reversible amenorrhea and the clinical effect is similar to ovarian ablation. some studies have demonstrated the efficacy of zoladex in treating pre and perimenopausal hormone dependent breast cancer in both adjuvant and metastatic settings. few data is available on zoladex in neoadjuvant treatment for breast cancer in our departments, neoadjuvant cef regimen is of general practice, and a preliminary study is designed to investigate whether adding zoladex into neoadjuvant cef could further improve results in hormone responsive breast cancer.

Eligibility criteria:
inclusion criteria: 1. provision of informed consent 2. pathological confirmation of breast cancer 3. tumor stage(tnm):t2-4bn0-3m0 4. er(+) and/or pr(+). 5. premenopausal woman. 6. age≥40 years 7. measurable disease as per recist criteria 8. karnofsky≥70 9. labratory criteria: * plt≥100\*109/l * wbc≥4000/mm3 * hgb≥10g/dl * alt and ast\<2\*uln exclusion criteria: 1. presence of metastatic disease. 2. inflammatory breast cancer. 3. bilateral breast cancer. 4. previous chemotherapy or hormonal therapyfor current breast neoplasm. 5. other malignant tumor (concurrent or previous). 6. pregnant woman. 7. hypersensitive to any drug in cef regimen or any ingredient of zoladex. 8. any severe systemic disease contraindicating chemotherapy.

Keywords: to observe the biological changes under concurrent zoladex and cef as neoadjuvant regimen with respect to the er,pr,cerbb-2 status before and after therapy
subcutaneous ketamine for postoperative pain relief in rwanda

Conditions: Post Operative Pain; Pain

Summary: a randomized double blind control trial to investigate the safety and efficacy of subcutaneous ketamine for control of post operative pain in low resource settings.

a randomized double blind control trial. all patients undergoing upper abdominal, thoracic, gynecologic or orthopaedic surgeries at the centre hospitalier universitaire de kigali, kigali, rwanda will be invited to participate. enrolled patients will receive subcutaneous ketamine (or placebo) administered immediately after surgery, the evening after surgery, and every 12 hours thereafter for a total of 5 injections at a dose of 1mg/kg. the primary outcome will be a reduction in mean pain scores using parametric statistical analysis to discriminate significance. pain will be measured using an 11-point numerical rating scale. secondary outcomes will be the presence of significant side effects. this trial is a partnership between the university of saskatchewan and the national university of rwanda with ethics approval from each institutions ethics board.

Eligibility criteria:
inclusion criteria: - all patients undergoing upper abdominal, thoracic, gynecologic or orthopaedic surgeries during a one month period with expected post operative hospital admission exclusion criteria: * allergy to ketamine * history of narcotic abuse or dependence * those patients for which decreased cognitive function is a barrier to accurate data collection
randomized trial of glutathione with anti-pd-1 and chemotherapy in advanced nsclc

Conditions: Non-Small Cell Lung Cancer; Chemotherapy; PD1 Antibody; Glutathione

Summary: chemotherapeutic agents exert significant immunomodulatory effects by influencing tumor-infiltrating immune cells. however, the sequence and combination of chemotherapy regimens differentially modulate immune cell dynamics, ultimately impacting treatment efficacy and patient survival. glutathione, a critical bioactive molecule, demonstrates broad potential in tumor immunotherapy. through mechanisms such as scavenging free radicals, modulating immune cell proliferation and differentiation, and regulating cytokine expression, glutathione achieves precise modulation of immune responses to enhance immune system functionality. to investigate whether glutathione can enhance the clinical efficacy of current chemo-immunotherapy regimens in non-small cell lung cancer (nsclc), investigators conducted this clinical study.


Eligibility criteria:
inclusion criteria: 1. histologically or cytologically confirmed diagnosis of lung squamous cell carcinoma or adenocarcinoma. 2. documented disease progression following first-line chemotherapy or chemo-immunotherapy. 3. age ≥18 years at the time of enrollment. exclusion criteria: 1. patients with small cell lung cancer or other histological subtypes of lung cancer. 2. patients lost to follow-up, who discontinued treatment, or died within one year of diagnosis. 3. pregnant or lactating women
a study to test efficacy and safety of rozanolixizumab in adult patients with generalized myasthenia gravis

Conditions: Generalized Myasthenia Gravis

Summary: the purpose of the mycaringstudy is to demonstrate the clinical efficacy and to assess safety and tolerability of rozanolixizumab in patients with generalized myasthenia gravis (mg).


Eligibility criteria:
inclusion criteria: * study participant must be ≥18 years of age, at the time of signing the informed consent * study participant has documented diagnosis of generalized myasthenia gravis (gmg) at visit 1, based on study participant's history and supported by previous evaluations * study participant has a confirmed positive record of autoantibodies against acetylcholine receptor (achr) or muscle-specific kinase (musk) at screening (visit 1).the presence of autoantibodies may be confirmed with repeat testing at visit 1 * study participant has myasthenia gravis foundation of america (mgfa) class ii to iva at visit 1 * study participant with a myasthenia gravis-activities of daily living (mg-adl) score of at least 3 (with ≥3 points from non-ocular symptom) and a quantitative myasthenia gravis (qmg) score of at least 11 at visit 1 and at baseline (visit 2) * study participant is considered for additional treatment such as intravenous immunoglobulin g (ivig) or plasma exchange (pex) by the investigator exclusion criteria: * study participant has a known history of hyperprolinemia * study participant has a clinically relevant active infection (eg, sepsis, pneumonia, or abscess) in the opinion of the investigator, or had a serious infection (resulting in hospitalization or requiring parenteral antibiotic treatment) within 6 weeks prior to the first dose of investigational medicinal product (imp) * study participant with a known tuberculosis (tb) infection, at high risk of acquiring tb infection, or latent tuberculosis infection (ltbi), or current/history of nontuberculous mycobacterial infection (ntmbi) will be excluded * study participant has experienced hypersensitivity reaction after exposure to other anti-neonatal fc receptor (fcrn) drugs * study participant with severe (defined as grade 3 on the myasthenia gravis-activities of daily living (mg-adl) scale) weakness affecting oropharyngeal or respiratory muscles, or who has myasthenic crisis or impending crisis at visit 1 or visit 2 * study participant has a history of a solid organ transplant or hematopoietic stem cell/marrow transplant

Keywords: ucb7665 generalized myasthenia gravis rozanolixizumab gmg
the healthy weight for life program

Conditions: Overweight; Obesity; Compliance Behavior

Summary: this study is a randomized controlled pilot of a work site weight control intervention. the purpose of the pilot is to obtain preliminary data for future nih submissions. four work sites were identified through a multistage recruiting process. work sites were randomized to either the intervention group, which will receive the intervention immediately following randomization or the control group which will receive a shortened intervention over a 1-month period, 6 months after the active intervention sites have completed their program. the intervention will consist of a variety of activities conducted over a 6 month period, that are overseen by a work site-tufts oversight group, including the following optional elements: for overweight and obese individuals, regular support groups for weight loss and prevention of weight regain. for all work site employees irrespective of weight, handouts and posted informational resources on healthy eating, monthly lunchtime seminars, and food sampling to facilitate healthy eating patterns for prevention of weight gain. basic online assessments on health and nutrition will be carried out at baseline (week 0) and 24 weeks in all work site employees willing to provide information. more detailed online and in-person assessments will be performed throughout the 24-week study period in the weight loss support group participants (intervention sites) and individuals intending to enroll in the support group (control sites).


Eligibility criteria:
inclusion criteria: * willing to sign a consent form. * bmi during screening ≥25 kg/m2 (eligibility for weight loss support group) * participants must not have had any surgical procedures influencing weight regulation to include, but not limited to, gastric bypass, other bariatric surgeries, resection of small or large intestine leading to malabsorption, gastric resection for ulcers or cancer, and esophageal resection * intention to follow recommended program and complete outcome assessments and requested self-monitoring. * obtain a physician's clearance form

Keywords: worksite group weight loss behavioral components