Kornimate/medical-research-clean huggingface dataset:
auto-regulated blood flow restriction in athletes with recurrent ankle sprain

Conditions: Ankle Sprain; Ankle Instability

Summary: ankle injuries, especially lateral ankle sprains, are prevalent in physically active individuals. blood flow restriction training (bfrt) has emerged as a promising method, employing partial arterial occlusion and full venous occlusion with low resistance to induce metabolic stress and achieve outcomes akin to heavy resistance training. this randomized controlled study explores the application of bfrt in addressing chronic ankle instability (cai), focusing on its efficacy in strength gains of extrinsic foot muscles, and potential benefits in functional performance.

ankle injuries, especially lateral ankle sprains, are prevalent in physically active individuals. blood flow restriction training (bfrt) has emerged as a promising method, employing partial arterial occlusion and full venous occlusion with low resistance to induce metabolic stress and achieve outcomes akin to heavy resistance training. this randomized controlled study explores the application of bfrt in addressing chronic ankle instability (cai), focusing on its efficacy in strength gains of extrinsic foot muscles, and potential benefits in functional performance. at the sharjah university medical campus, 45 athletes from shabab al ahli club, aged 18-40, participated in this randomized control study. the investigators randomly allocated the participants into three equal groups, with 15 individuals in each group. the investigators recruited the first group to an auto-regulated blood flow restriction training plus traditional treatment program (arbfrt+tt), the second group to a non-regulated blood flow restriction training plus traditional treatment program (nrbfrt+tt), and the third group to a traditional treatment program only without bfrt (tt group). the investigators assessed extrinsic foot muscle strength using an isokinetic device and functional performance using functional ankle disability index (fadi) and rate of perceived exertion scale (rpes), both pre- and post 6-week treatment.

Eligibility criteria:
inclusion criteria: * age ranges from 18 to 40 years. * no other health related conditions such as diabetes or hypertension. * unilateral or bilateral cia. * male athletes. exclusion criteria: * knee or hip injury within the last 3 months. * previous ankle surgery. * any contraindication for bfrt application such as venous insufficiency, arterial insufficiency, history of dvt. * spinal lesion affecting lower limb function. * females

Keywords: ankle instability blood flow restriction fatigability
a phase 1b study of budoprutug in systemic lupus erythematosus (sle)

Conditions: Systemic Lupus Erythematosus

Summary: the main objective is to assess the safety and tolerability of budoprutug in adults with sle. pharmacokinetics, pharmacodynamics, and preliminary clinical efficacy will also be assessed.

budoprutug is a humanized, immunoglobulin (ig) g1 monoclonal antibody that selectively binds to cd19 and is projected to deplete targeted cells through antibody-dependent cellular cytotoxicity. this phase 1b, open-label study will evaluate budoprutug administered as a single intravenous infusion in ascending dose cohorts of patients aged 18 years and above with active, seropositive sle and inadequate response to standard therapy. the study will also assess the pharmacokinetics, pharmacodynamics and early indications of efficacy of budoprutug in sle, where pharmacodynamics will be evaluated as the change in the number of b cells and immunoglobulins (antibodies) in the blood over time following a single infusion.

Eligibility criteria:
inclusion criteria: 1. aged 18 to 65 years at the time of consent. 2. diagnosis of sle according to the 2019 european league against. rheumatism and the american college of rheumatology (acr) classification criteria. 3. active, seropositive disease, with sledai 2k \>=8. 4. inadequate response to at least 2 therapeutic interventions, including at least one oral immunosuppressive or biologic standard-of care therapy. exclusion criteria: 1. active neuropsychiatric sle. 2. history of inflammatory or autoimmune diseases including, but not limited to, rheumatoid arthritis, scleroderma, myositis, vasculitis, inflammatory bowel disease, or other conditions that require immune suppressive therapy. subjects with stable concurrent sjogren's, asthma, or autoimmune thyroid disease may be considered for participation. 3. active systemic infection or history of chronic, recurrent, latent, or recent serious infections.

Keywords: lupus sle biologics open-label monoclonal anti-cd19
a study of e3810 for japanese subjects with functional dyspepsia (samurai study: suppression of acid milieu with rabeprazole improving functional dyspepsia ) (study e3810-j081-204)

Conditions: Functional Dyspepsia

Summary: the purpose of this study is to assess the efficacy and safety of rabeprazole compared to placebo in japanese subjects with functional dyspepsia.


Eligibility criteria:
inclusion criteria: -participants diagnosed as functional dyspepsia according to rome iii criteria. exclusion criteria: * participants with neuropsychiatric disorder. * participants diagnosed with irritable bowel syndrome, inflammatory bowel disease and serious constipation.

Keywords: dyspepsia rabeprazole japan
study of cemiplimab in patients with type of skin cancer stage ii to iv cutaneous squamous cell carcinoma

Conditions: Cutaneous Squamous Cell Carcinoma

Summary: the primary objective of the study is to evaluate the efficacy of neoadjuvant cemiplimab as measured by pathologic complete response (pcr) rate per independent central pathology review. the secondary objectives of the study are: * to evaluate the efficacy of neoadjuvant cemiplimab on measures of disease response, including: * major pathologic response (mpr) rate per independent central pathology review * pcr rate and mpr rate per local pathology review * orr prior to surgery, according to local assessment using recist 1.1 * to evaluate the efficacy of neoadjuvant cemiplimab on event free survival (efs), disease free survival (dfs), and overall survival (os) * to evaluate the safety profile of neoadjuvant cemiplimab * to assess change in surgical plan (ablative and reconstructive procedures) from the screening period to definitive surgery, both according to investigator review and independent surgical expert review * to assess change in post-surgical management plan (radiation, chemoradiation, or observation) from the screening period to post-surgery pathology review, both according to investigator review and independent surgical expert review


Eligibility criteria:
key inclusion criteria * stage ii to iv (m0) cscc, for which surgery would be recommended in routine clinical practice. for stage ii patients, lesion must be ≥3 cm at the longest diameter. * at least 1 lesion that is measurable by recist 1.1 * eastern cooperative oncology group (ecog) performance status of 0 or 1 * adequate organ, bone marrow function, and hepatic function as defined in the protocol key exclusion criteria * solid malignancy within 5 years of the projected enrollment date, or hematologic malignancy (including chronic lymphocytic leukemia \[cll\]) at any time * distant metastatic disease (m1), visceral and/or distant nodal * prior radiation therapy for cscc * patients with a condition requiring corticosteroid therapy (\>10 mg prednisone/day or equivalent) within 14 days of the first dose of study drug. * patients with active, known, or suspected autoimmune disease that has required systemic therapy within 5 years of the projected enrollment date. * history of interstitial lung disease (eg, idiopathic pulmonary fibrosis, organizing pneumonia) or active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management. * uncontrolled infection with human immunodeficiency virus (hiv), hepatitis b or hepatitis c virus (hbv or hcv) infection; or diagnosis of immunodeficiency * active tuberculosis note: other protocol-defined inclusion/exclusion criteria apply

Keywords: cscc stage ii stage iii stage iv cscc of head/neck cscc of extremity cscc of trunk
nourish+: nourishing our understanding of role modeling to improve support and health

Conditions: Overweight and Obesity

Summary: the purpose of this study is to evaluate the efficacy of a parent intervention (nourish+) aimed at reducing the problem of overweight and obesity in children.

pediatric overweight is a national public health concern. the percentage of overweight children in the u.s. between the ages of 5 and 11 has nearly tripled in the last 3 decades. african american children are particularly at risk. pediatric overweight is associated with numerous physical and psychological health problems. moreover, overweight children are at significant risk for obesity in adulthood. thus, a focus on pediatric overweight is an important step in the prevention of adult obesity. despite the urgent need for pediatric overweight interventions, outcomes of some of the most rigorous treatments are, at best, mixed. although research has found that including parents in interventions for pediatric overweight has positive effects on outcomes, parental involvement is usually limited. moreover, relatively few studies have included sufficient numbers of lower-ses, african american participants, a group at increased risk for pediatric overweight and associated complications. this study will evaluate the efficacy of an intensive intervention targeting ethnically diverse parents of overweight, children ages 5-11 (nourish-nourishing our understanding of role modeling to improve support and health).

Eligibility criteria:
inclusion criteria: * parents/caregivers must be at least 18 years old * parents/caregivers must have a child between the ages of 5 and 11 with a bmi \> the 85th percentile, who primarily resides in the caregiver's home * parents/caregivers need to speak english, be able to follow basic instructions, and perform simple exercises exclusion criteria: * non-ambulatory parents/caregivers * pregnant parents/caregivers * parents/caregivers who have a medical condition that might be negatively impacted by exercise * parents/caregivers who have a psychiatric diagnosis that would impair their ability to respond to assessments or participate in a group * parents whose children have a medical or developmental condition that precludes weight loss using conventional diet and exercise methods

Keywords: pediatric overweight pediatric obesity
t2* mri analysis for sarcoma

Conditions: Radiotherapy; Magnetic Resonance Imaging; Sarcoma

Summary: t2\* imaging is a method to identify labile iron pools in tumor cells. these iron pools may be linked to better treatment outcomes for specific types of therapy. this is a small pilot study to see if radiation therapy changes the amount of iron in a sarcoma tumor.


Eligibility criteria:
inclusion criteria: * pathologically confirmed sarcoma, by biopsy or excision * prescribed radiation therapy as per standard of care * treatment to begin within 5 weeks after surgery or biopsy * ecog 0, 1, or 2 * ability and willingness to provide informed consent exclusion criteria: * \< 18 years of age

Keywords: soft tissue sarcoma
observational study on obese patients during general anesthesia

Conditions: Bronchospasm; Surgery; Obesity

Summary: there is increased frequency of asthma in obese patients. this study is trying to find out if there is a difference in the presence of bronchospasm during anesthesia in obese and non obese patients.

obese patients come for surgery every day. in this specific population the frequency of asthma is high. problems from the respiratory system increase the morbidity, as they are a significant part of perioperative complications. the frequency and the severity of bronchospasm have not been studied. any data concerning the bronchospasm will lead to better perioperative management. in this study the investigators study any sign of bronchospasm during surgery in obese patients.

Eligibility criteria:
inclusion criteria: * age \> 18 and \< 78 years * bmi \< 35 exclusion criteria: * mental disorders emergency surgeries

Keywords: bronchospasm laparoscopic gastrectomy obesity
isometric contraction-based pain modulation versus eccentric strengthening in treating achilles tendinopathy

Conditions: Achilles Tendinopathy

Summary: achilles tendinopathy is a common overuse injury that leads to pain and functional limitations. traditional rehabilitation focuses on eccentric strengthening, which has been widely studied for its benefits in promoting tendon remodeling and improving strength. however, recent research suggests that isometric contractions may offer superior pain modulation effects, especially in the early stages of rehabilitation.

this study aims to compare the effectiveness of isometric contraction-based pain modulation versus eccentric strengthening in treating achilles tendinopathy. isometric exercises involve maintaining a static muscle contraction, which has been shown to reduce pain through neuromuscular mechanisms, potentially making it a valuable alternative or complement to eccentric loading.

Eligibility criteria:
inclusion criteria: * clinically diagnosed with achilles tendinopathy using mri * at least 3 months incidence period of achilles tendinopathy * must be able to attend all treatment sessions and follow-up assessments. * ability to walk independently without any assistive devices. exclusion criteria: * severely restricted rom of ankle * patients who underwent surgery for achilles tendinopathy * patients who had undergone previous surgery of lower limb extremity * those using ankle orthosis * patients with systemic diseases affecting ankle (osteoarthritis, rheumatoid arthritis, and osteoporosis) * individuals with neurological disorders affecting the lower limbs. * systemic conditions like diabetes, cardiovascular diseases.
non-operative management and early response assessment in rectal cancer

Conditions: Adenocarcinoma of the Lower Rectum

Summary: the investigators' data from a phase i study of short course radiation therapy followed by chemotherapy showed 74% complete clinical response (ccr). given the promising response rate, the investigators are evaluating short course radiation therapy (scrt) followed by chemotherapy in a multi-institution phase ii trial to validate the ccr rate of this treatment paradigm. scrt has not been prospectively evaluated in non-operative management for patients with non-metastatic rectal adenocarcinoma.


Eligibility criteria:
inclusion criteria: * diagnosis of biopsy proven stage i-iiib (ct1-3, n0-2a, m0) adenocarcinoma of the rectum; staging must also be based on multidisciplinary evaluation including mri * tumor ≤ 12 cm from anal verge as determined by mri or endoscopy * clinically detectable (mr, endoscopy, or dre) tumor present * eastern cooperative oncology group (ecog) performance status 0-2 * at least 18 years of age * adequate bone marrow function defined as: * absolute neutrophil count (anc) \> 1,500 cells/mm3 * hemoglobin\> 8 g/dl * platelets \>100,000 cells/mm3 * women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. * able to understand and willing to sign an institutional review board (irb)-approved written informed consent document. exclusion criteria * prior radiation therapy, chemotherapy or extirpative surgery for rectal cancer. * prior oxaliplatin or capecitabine use for any malignancy * no prior radiation therapy to the pelvis. * a history of other malignancy (except non-melanomatous skin cancers) with the exception of malignancies for which all treatment was completed at least 2 years before registration and the patient has no evidence of disease. * currently receiving any investigational agents. * a history of allergic reaction attributed to compounds of similar chemical or biologic composition to capecitabine, 5fu, oxaliplatin, or leucovorin. * uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia. * pregnant and/or breastfeeding. women of childbearing potential must have a negative serum pregnancy test within 14 days of study entry. * patients with hiv are eligible unless their cd4+ t-cell counts are \< 350 cells/mcl or they have a history of aids-defining opportunistic infection within the 12 months prior to registration. concurrent treatment with effective antiretroviral therapy (art) according to department of health and human services (dhhs) treatment guidelines is recommended. hiv testing for patients without a history of hiv is not a protocol requirement.
adherence to lung cancer screening by low-dose thoracic ct in haut-rhin department, france.

Conditions: High-Risk Cancer; Lung Cancer

Summary: the main objective of the study is to measure adherence to a lung cancer screening program using low-dose thoracic ct.

secondary objectives 1. to evaluate patient compliance over the entire duration of the screening program 2. to assess patient smoking cessation 3. to describe radiation doses received during ct scans 4. to identify organizational constraints for general practitioners 5. to compare stages at diagnosis before and after implementation of screening program conduct of research eligible patients will be identified by general practitioners. patients included will require a low-dose thoracic ct scan to be performed by a radiologist of their choice. smoking cessation will be systematically proposed, and will be carried out by the general practitioner or a tobaccologist. the radiation dose from thoracic ct scans should not exceed 100 mgy.cm product dose length (i.e. \< 1.5 msv). imaging reports will be forwarded to the general practitioner. if the first ct scan is negative (t0): a second scan will be scheduled 1 year later (t1). if this second scan is also negative, in the absence of lung cancer risk factors other than smoking, scans will then be performed every two years. in the presence of a risk factor for lung cancer (other than tobacco), screening will remain annual. in the event of a result classified as uncertain: a follow-up scan is scheduled at 3 months ; if the follow-up scan is negative, the next screening will be scheduled 1 year after this follow-up scan. if the screening performed 1 year later is also negative, subsequent screenings will be performed annually. in the event of a positive result: the general practitioner will refer the patient to a pneumologist of his/her choice for further examinations; data from these additional examinations will be collected. the screening protocol may evolve in line with recommendations issued by the french national authority for health (has). for participants undergoing ct scan at the imaging department of emile muller hospital in mulhouse (ghrmsa), a blood sample will be collected (optional) for subsequent biomarker assays.

Eligibility criteria:
inclusion criteria: * patients aged 50 to 74 years * smoking or having smoked (withdrawal of \<15 years): ≥15 cigarettes/day for ≥25 years or ≥10 cigarettes/day for ≥30 years * affiliated or beneficiary of a social security scheme * written informed consent exclusion criteria: * inability to walk up two flights of stairs without stopping * bmi \> 35 kg/m² * recent chest ct scan \< 1 year * personal history of lung cancer \< 5 years or under treatment * personal history of cancer being monitored by chest ct scan * contraindication to lung cancer treatment or diagnostic investigations * current or recent respiratory symptoms immediately suggestive of lung cancer * pregnant or breast-feeding woman * person under court protection, guardianship or curatorship * person deprived of liberty by judicial or administrative decision.

Keywords: screening low dose chest computed tomography lung cancer
a study evaluating 24-week and 48-week telaprevir-based regimen in treatment naïve subjects with genotype 1 chronic hepatitis c who achieve an extended rapid viral response

Conditions: Hepatitis C

Summary: this study is being conducted to learn more about the safety and effect of telaprevir in combination with peginterferon alfa-2a (peg-ifn) and ribavirin (rbv) in participants with hepatitis c who have never been treated for their hepatitis c virus (hcv). the study is designed to look at the relative benefits of 24 or 48 weeks of total treatment in people who respond quickly to a telaprevir-based treatment.


Eligibility criteria:
inclusion criteria: * has not received any previous treatment with any approved or investigational drug or drug regimen for the treatment of hepatitis c * male and female subjects, 18 to 70 years of age, inclusive * genotype 1, chronic hepatitis c with detectable hcv rna. * screening laboratory values, tests, and physical exam within acceptable ranges * able and willing to follow contraception requirements * able to read and understand, and willing to sign the informed consent form and abide by the study restrictions. exclusion criteria: * subject has any contraindications to pegasys® or copegus® therapy * evidence of hepatic decompensation in cirrhotic subjects * history of organ transplant * history of, or any current medical condition which could impact the safety of the subject in participation in the study

Keywords: genotype 1
study on the optimal combination pattern of the combined treatment of radiotherapy and immunotherapy for the abscopal effect in non-small cell lung cancer (nsclc) with multiple metastases

Conditions: NSCLC Stage IV Without EGFR/ALK Mutation

Summary: this study aims to conduct a prospective, multicenter, umbrella clinical study to compare the abscopal effects of different radiotherapy fractionation patterns combined with benmelstobart, and to explore an efficient and low-toxic treatment strategy for non-small cell lung cancer (nsclc) with multiple metastases. the main objective is to explore and compare the control rates of abscopal lesions in nsclc patients with multiple metastases when different radiotherapy fractionation patterns are combined with benmelstobart.


Eligibility criteria:
inclusion criteria: * patient must meet all of the following inclusion criteria to be enrolled in this study: 1. non-small cell lung cancer confirmed by pathological histology. 2. more than 3 metastatic lesions. 3. no brain metastases or stable lesions. 4. negative for driver genes (including egfr, alk, ros, braf, met, ret). 5. performance status (ps) score of 0-1, with an expected survival period of more than 3 months. 6. age between 18 and 75 years old. 7. assessment by pet-ct (including fdg and fmiso, not mandatory). 8. no contraindications to immunotherapy and radiotherapy. 9. signed the informed consent form. exclusion criteria: * patients with any of the following criteria are not eligible for enrollment in this study: 1. those with severe dysfunction of important vital organs (heart, liver, kidney). 2. those accompanied by other malignant tumors. 3. uncontrolled heart diseases or myocardial infarction within the past 6 months. 4. those with a history of mental illness. 5. other situations in which the researcher deems it inappropriate for the subject to participate in the study.