Kornimate/medical-research-clean huggingface dataset:
fs120 phase 1/1b study in patients with advanced malignancies

Conditions: Advanced Cancer; Metastatic Cancer

Summary: this is a phase 1/1b, multicenter, open label study to evaluate the safety and antitumor activity of fs120, an ox40/cd137 bispecific antibody, alone and in combination with pembrolizumab, in subjects with advanced malignancies


Eligibility criteria:
inclusion criteria: * measurable disease * eastern cooperative oncology group performance status 0-1. * highly effective contraception if risk of conception exists * a female subject is eligible if not pregnant, not breastfeeding, not a woman of childbearing potential (wocbp) or is a wocbp that uses highly effective contraception * subjects with hiv who are healthy and how a low risk of acquired immunodeficiency syndrome related outcomes * for combination part: subjects must have histologically confirmed locally advanced, unresectable or metastatic solid tumours where there is regulatory approval for use of pembrolizumab as a monotherapy agent exclusion criteria: * prior systemic anticancer therapy within 28 days or 5- half-lives, whichever is shorter, before the first dose of study drug. * prior therapy with any ox40 agonist, cd137 (4-1bb) agonist, cd40 agonist, gitr, or cd27 targeting therapy (single agent or combination). * prior radiotherapy within 2 weeks of start of study treatment. * hiv infected participants with a history of kaposi sarcoma and/or multicentric castleman disease. * uncontrolled central nervous system (cns) metastases and/or carcinomatous meningitis, primary cns tumours, or solid tumours with cns metastases as the only measurable disease. * prior history of any grade ≥3 immune-related ae (irae) that has not improved to grade ≤1; any grade ≥3 irae that resulted in discontinuation of treatment, significant (grade ≥3 nci ctcae version 5.0) treatment-related cytokine release syndrome. * use of immunosuppressive agents, hypersensitivity or intolerance to monoclonal antibodies or their excipients, persistent grade ≥1 nci ctcae version 5 toxicity related to prior therapy or any condition that would significantly impair and/or prohibit the participant's participation in the study, as per the investigator's judgement. * vaccination with a live vaccine within 30 days before first dose of study drug. * participants with a known additional malignancy that is progressing or has required active treatment in the past 3 years. * participants with severe hypersensitivity (≥grade 3) to pembrolizumab and/or any of its excipients.

Keywords: immuno-oncology bispecific antibody dose escalation cohort expansion ox40 cd137 (4-1bb) invox pembrolizumab pd-1
are paraspinous intramuscular injections of botulinum toxin a (bont-a) efficient in the treatment of chronic low-back pain (lbp)?

Conditions: Chronic Low-back Pain

Summary: studying the therapeutic effect of paravertebral injections of bont-a (botulinum toxin a) requires further studies to confirm the reported short-term therapeutic effect and to determine potential predictive factors of efficacy.

this study was a randomized, double-blinded, placebo-controlled phase 3 trial comparing bont-a type a injections to a placebo in patients with chronic low-back pain (lbp). this superiority trial obtained support from the french hospital clinical research project (phrc) and the approval of a french ethics committee (2003/02) ("comité sud-ouest et outre-mer iii", consent obtained in february 2003). the number of participants included in the study was chosen to be similar as those included in previous studies, that showed a strong positive effect of bont-a injections on lbp. furthermore, the design of our study (i.e. a crossover) increased the power of the statistical analysis. a scientific committee has been solicited at this step, after including 19 patients, to assess the results.

Eligibility criteria:
inclusion criteria: * lbp defined as a pain located between the thoracic lumbar hinge and the gluteal sulcus, where pain had evolved over a period of 6 months despite well conducted medical treatment, self-assessed lumbar pain intensity over 50 millimeters long on a visual analogue scale of 100 millimeters (0=no pain; 100=maximal pain), * having been on sick leave for 60 or more days in the year preceding the inclusion (in order to include patients with high consequences of chronic low-back pain on their work), * same long-term chronic pain treatment for at least 6 weeks exclusion criteria: * age under 18 or over 55 years (to avoid secondary causes of low back pain, like spinal tumor), * ongoing pregnancy or breast-feeding, * a neuromuscular pathology (myasthenia gravis, amyotrophic lateral sclerosis, myopathy, polymyositis), aminoglycoside treatment at the time of inclusion, * skin infection at injection points, * diabetes and alcoholism (in order to avoid other etiologies of chronic pain), * a history of injecting bont-a a, * anticoagulation treatment, sciatica, * suspected spinal inflammatory disorder (spondylitis, inflammatory rheumatism, tumoral pathology), * a failed back surgery syndrome (when surgery failed to relieve low-back pain), - incapacity to stand, cardiorespiratory deficiency which does not allow the isokinetic exploration of the spinal muscles, * cognitive disorders limiting patient participation, * conflicts of interest owing to existing pain (unconsolidated work accident, ongoing damage compensation). * spine infection, tumour or trauma had been specifically excluded by an mri done by all patients before the inclusion in the present study. * no patient was allowed to take opiates during the time of the study, * facet joint injections were also not permitted during the study period.
core stabilization for the treatment of anterior knee pain

Conditions: Patellofemoral Pain Syndrome

Summary: the investigators hypothesize that the use of trunk (core) stabilization exercises early in treatment combined with lower extremity exercises will enhance the outcome over lower extremity exercises alone in the treatment of young athletes with anterior knee pain.


Eligibility criteria:
inclusion criteria: * subjects between 13-20 years of age clinically diagnosed with anterior knee pain. * pain should be peripatellar and should include at least 3 of the following: 1. experienced during or after activity 2. prolonged sitting 3. with stair climbing or descending 4. squatting 5. kneeling. * the subject should be active for at least 30 minutes per day. exclusion criteria: * previous knee surgery * signs and symptoms of a specific structural diagnosis not consistent with akp such as meniscal, acl, pcl, or collateral ligament tears, pain referral from hip or lumbar spine (determined during examination), traumatic patellar dislocation, an inability to adequately understand or communicate in english.

Keywords: patellofemoral pain syndrome abdominal muscles
adipose-derived stromal cells (asc's) for pressure ulcers

Conditions: Pressure Ulcer

Summary: this pilot study of 12 patients will test the safety and efficacy of applying autologous, adipose-derived stromal cells (ascs), uncultured, on a stage iii or iv pressure ulcer or diabetic foot ulcers. patients will undergo a minimal risk liposuction procedure to withdraw 50-100 cc of adipose tissue. the tissue would be processed to extract the stromal layer of cells that contain stem cells. the ascs would be injected into a fibrin sealant to be applied to the wound. patients would be followed for 6 weeks to assess wound healing and tolerance of the treatment.

wound healing for stage iii and iv pressure ulcers or diabetic foot ulcers can take four to six weeks or longer and cost upwards of $40,000 to treat. past studies have shown that adipose tissue contains progenitor cells or regenerative cells that can release multiple angiogenic growth factors and cytokines including vascular endothelial growth factor (vegf), hepatocyte growth factor (hgf) and chemokine stromal cell-derived factor-1 (sdf-1). a current literature review revealed that there is research related to use of stem cells to enhance wound healing, in particular with ischemic or radiation-induced ulcers. however, there is limited research completed on use of stem cells or ascs with pressure ulcers. the goal is to heal pressure ulcers faster and prevent further complications using the patient's own natural ascs.

Eligibility criteria:
inclusion criteria * males and females * stage iii pressure ulcers measuring 5 cc - 36 cc in volume (as measured by filling the wound with normal saline). * inpatient or outpatient treatment of pressure ulcers * diabetic foot ulcer stage 1 or 2 of any size * co-morbidities may include: * peripheral vascular disease (pvd) * coronary artery disease (cad) * chronic renal disease (crd) * chronic liver disease (cld) * hypertension (htn) * diabetes * the ability of subjects to give appropriate consent or have an appropriate representative available to do so * the ability of subjects to return for weekly wound assessments exclusion criteria * patients with allergies to tisseel, tegaderm, or silicon * diabetics with poor glucose metabolic control (hba1c \> 9) * target wounds that are in close proximity to potential cancerous lesions * patients who require negative pressure wound therapy (npwt), limb amputation, or surgical intervention at the target wound at the time of screening * wounds located on the face * patients with stage 5 or 6 peripheral vascular disease (specifically, wounds that are caused by peripheral vascular disease such as leg ulcers) * wounds caused by diabetes mellitus (diabetic foot ulcers). * bmi of \<16 clinical signs of critical colonization or local infection * prolonged (\> 6 months) use of steroids * patients on active regimen of chemotherapy * patients receiving radiation in proximity of wound * decompensated chronic liver disease

Keywords: stem cells
quality of life in african-american or caucasian female breast cancer survivors

Conditions: Breast Cancer; Cancer Survivor; Depression; Fatigue; Sexual Dysfunction; Sleep Disorders; Spiritual Concerns

Summary: rationale: studying quality of life in cancer survivors may help determine the long-term effects of breast cancer and may help improve the quality of life for future cancer survivors. purpose: this clinical trial is studying the quality of life in african-american or caucasian female breast cancer survivors.

objectives: * compare disease-specific, generic, and global quality of life measures in african-american survivors of breast cancer with caucasian survivors of breast cancer. * compare these quality of life measures in african-american survivors of breast cancer with control group of african-american women with no history of breast cancer. outline: patients and healthy participants complete a battery of quality of life (qol) questionnaires over approximately 65 minutes by mail or over the phone, including the sexual function index, functional assessment of cancer therapy - fatigue, concerns about recurrence scale, and other measures of symptoms/side effects (including sleep problems), the rand physical functioning -10 scale, center for epidemiologic studies - depression scale, assessment of family function/social support, enrich marital satisfaction scale, reed spiritual perspective scale, assessments of coping and body image, post-traumatic growth inventory, and the index of well-being. demographic, disease, treatment, and comorbidity information, as well as menstrual and gynecological history, work status and insurance history, and a measure of health care provider communication is collected using questionnaires and medical chart review. projected accrual: a total of 195 patients and healthy participants will be accrued for this study.

Eligibility criteria:
disease characteristics: * meets 1 of the following criteria: * african-american or caucasian breast cancer survivor * diagnosed with stage i-iii breast cancer between the years of 1995-2003 * receiving follow up care at the indiana university cancer center (iucc), the iucc northside clinic, spring mill clinic, or wishard memorial hospital * healthy african-american * acquaintance of an african-american breast cancer survivor * not known to have breast cancer patient characteristics: * female prior concurrent therapy: * see disease characteristics

Keywords: fatigue depression spiritual concerns sexual dysfunction sleep disorders cancer survivor stage ia breast cancer stage ib breast cancer stage ii breast cancer stage iiia breast cancer stage iiib breast cancer stage iiic breast cancer
active surveillance on papillary thyroid microcarcinoma

Conditions: Thyroid Cancer; Papillary Thyroid Microcarcinoma

Summary: the study is a multi-center prospective cohort study of active surveillance in papillary thyroid cancer with low risk. the purpose of the study is to observe natural course of low risk papillary thyroid cancer in korean population, and comparison of prognosis between active surveillance group and conventional surgery group. patient will be well informed about their choice of active surveillance or surgery.


Eligibility criteria:
inclusion criteria: * who agreed to the agreement form * who is older than 18 years old * who was diagnosed by fine needle aspiration or needle biopsy of bethesda category v or vi * whose thyroid cancer is smaller than 1 cm length exclusion criteria: * who cannot routinely follow-up according to the study schedule * who was diagnosed by fine needle aspiration or needle biopsy of bethesda category i, ii, iii, or iv. * who have hyperthyroidism which needs treatment

Keywords: active surveillance
effects of the combination of rrt with tdcs on dyslexic adults

Conditions: Developmental Dyslexia

Summary: the purpose of the study is to evaluate the effectiveness of the combination of rhythmic reading training (rrt), a computer-assisted intervention method that combines sublexical reading exercises with rhythm processing, and transcranial direct current stimulation (tdcs) on reading abilities of a group of italian undergraduate students with dyslexia. two experimental conditions (active vs. sham) will be compared. finally, the effects of the intervention on other cognitive functions involved in the process of reading (i.e., rapid automatized naming, verbal working memory, rhythm perception abilities) will be measured.


Eligibility criteria:
inclusion criteria: * having been diagnosed with dd (icd-10 code: f81.0) on the basis of standard inclusion and exclusion criteria (icd-10: world health organization, 1992) and of the diagnosis procedure followed in the italian practice exclusion criteria: * presence of comorbidity with other neuropsychiatric or psychopathological conditions (whereas comorbidity with other learning disabilities were allowed) * exclusion criteria for the use of tdcs (e.g. epilepsy, pregnancy).

Keywords: reading developmental dyslexia music rhythm transcranial electrical stimulation transcranial direct current stimulation
effects of a home-based exercise intervention in subjects with long covid

Conditions: Long COVID-19; Post-COVID-19 Syndrome

Summary: the current coronavirus disease 2019 (covid-19) pandemic is the most severe health crisis of the 21st century. this is not only due to the deaths caused by the disease. people that were affected by covid-19 and supposedly recovered may suffer from long lasting sequelae. the presence of symptoms longer than 3 months after the infection with the severe acute respiratory syndrome coronavirus 2 (sars-cov-2) is referred to as post-covid-19 syndrome or long covid-19. it is estimated that 10-20 percent of all infected people are affected. the most common symptoms include persistent fatigue, reduced physical capacity, dyspnoea, ageusia, anosmia, musculoskeletal pain and neuropsychological complaints such as depression, anxiety, insomnia and a loss of concentration. considering the novelty of the pathology, evidence on the successful treatment of post-covid/long-covid is scarce. physical activity has been established as a treatment option for chronic diseases that have similar symptomatic manifestations to those of post-covid/long-covid. for example, exercise therapy has shown positive effects on the health status of patients with lung disease, depression, anxiety, insomnia and cognitive impairment. however, there has been controversy whether so-called graded exercise therapy (get) is a safe treatment strategy for patients with chronic fatigue syndrome (cfs). this population may experience post exertional malaise (pem), a worsening of symptoms after physical, cognitive or emotional exertion. since covid-19 might be an infectious trigger for cfs, particular caution has to be taken when recruiting participants and when screening them for adverse events and worsening of symptoms during an exercise intervention. it can be hypothesized that patients suffering from post-covid/long-covid can benefit from exercise in various ways, guaranteed that there is sufficient screening for pem before and during the intervention and training volume and intensity are increased slowly and progressively. the current study investigates the effects of a home-based concurrent training program on various parameters in people affected by long covid.


Eligibility criteria:
inclusion criteria: * laboratory-confirmed infection with sars-cov-2 via pcr a minimum of 12 weeks ago * presence of at least one or more of persistent symptoms that can be attributed to long-covid exclusion criteria: * previous or current hospitalization due to the covid-19 disease * regular engagement in endurance or strength training (more than once per week) in the six months prior to enrollment * contraindications for physical endurance and resistance exercise according to the guidelines of the american college of sports medicine (acsm) * a grade of 3 or higher on the post-covid-19 functional status scale (pcfs) * presence of post exertional malaise (pem)

Keywords: exercise exercise therapy concurrent training exercise rehabilitation long covid-19 post-covid-19 syndrome home-based training
nutritional prevention pilot trial for type 1 diabetes

Conditions: Type 1 Diabetes Mellitus

Summary: the overall objective of the study is to assess whether complete avoidance of cow's milk (cm) proteins, for at least the first 6 months of life, prevents type 1 diabetes (insulin-dependent diabetes mellitus, iddm) in genetically susceptible children who have a mother, biological father or sibling affected by type 1 diabetes.

among the environmental factors leading to type 1 diabetes in childhood, the most important are certain viral infections and possibly some dietary factors. among the latter cow's milk proteins are of special interest. they have been shown to be involved in the pancreatic beta-cell lesion in animal experiments. in humans there are some indications of a role of early exposure to cow's milk proteins as a risk factor for later type 1 diabetes. the hypothesis has not been confirmed, but a randomized, controlled double-blinded intervention trial should provide a definite answer. this study aims at assessing whether one can decrease the future incidence of beta-cell autoimmunity and/or type 1 diabetes in children who have an increased genetic risk for the disease, by administering in infancy after breast feeding until the age of 6-8 months such a formula, in which the cow's milk proteins have been hydrolyzed to smaller peptides. the children in the control group, carrying a similar increased genetic risk, will receive a conventional cow's milk based formula . this project is a pilot multicenter trial comprising 15 hospitals in finland.

Eligibility criteria:
inclusion criteria: * the participant must have a mother, biological father or sibling with type 1 diabetes * the participant must carry a susceptible hla genotype(hla-dqb1\*02 and/or dqb1\*0302 without protective alleles (dqb1\*0301, \*0602 and \*0603) exclusion criteria: * no telephone * no accessibility to any of the research centers * inability of parents to understand the study and instructions * unwillingness/inability to feed the infant cm-containing food for any reason (e.g. religious, cultural reasons) * gestational age less than 36 weeks * any severe illness such as chromosomal abnormalities, congenital malformations, respiratory failure, enzyme deficiencies of the newborn. * the newborn infant has received any cow's milk-based product prior to randomization

Keywords: dietary manipulation infants feasibility type 1 diabetes mellitus, beta-cell autoimmunity
is the use of blood platelets effective in the treatment of difficult fistulas related to the anal sphincter?

Conditions: Rectal Fistula

Summary: rationale: closure of the internal opening is the most accepted standard procedure in the treatment of peri-anal fistulas. the mucosal advancement flap is considered as golden standard. in one out of the three patients mucosal flap repair fails. possible causal factors are incomplete clearance of pus and debris, incomplete closure of the internal opening, inappropriate host response in patients with risk factors like smoking or diabetes. platelet derived growth factors may facilitate closure of the internal opening, especially in patients with impaired wound healing. objective: the use of autologous platelet rich plasma (prp) as an adjunct to the staged mucosal advancement flap to achieve a better closure rate of complex peri-anal fistula's. study design: randomized, multicenter trial. study population: patients with complex cryptoglandular peri-anal fistula's. intervention: injection of prp in the curretted fistula track under the mucosal flap. main study parameters/endpoints: * recurrence rate * post-operative pain * continence * quality of life. nature and extent of the burden and risks associated with participation, group relatedness: because autologous blood is used, no extra risk are expected.


Eligibility criteria:
inclusion criteria: * complex peri-anal fistula. * able to understand informed consent. exclusion criteria: * pregnancy * local malignancy * crohn's disease or ulcerative colitis * traumatic or iatrogenic lesion * thrombocytopenia * splenomegaly * bleeding disorders * hematologic malignancies

Keywords: rectal fistula peri-anal fistula platelet-rich plasma mucosa advancement flap
investigation of the effect of foam roller and kinesiotape application on performance parameters, pain and fatigue with football players

Conditions: Performance; Pain; Fatigue

Summary: the aim of our study is to compare the effects of foam roller plus dynamic stretching and kinesiotape plus dynamic stretching on performance parameters,pain and fatigue in football players. the results of our study will show the effects of the best choice between applications and help to reduce waste of time.

the aim of our study is to compare the effects of foam roller plus dynamic stretching and kinesiotape plus dynamic stretching on performance parameters,pain and fatigue in football players. the results of our study will show the effects of the best choice between applications and help to reduce waste of time. performance parameters include; flexibility, dynamic reaction time, sprint and agility. the hypotheses the investigators will test for this purpose; h1: foam roller application is more effective on performance parameters than kinesiotape application. h2: foam roller application is more effective on pain than kinesiotape application. h3: foam roller application is more effective on fatigue than kinesiotape application.

Eligibility criteria:
inclusion criteria: * playing in aydın adnan menderes university football team and volunteering. exclusion criteria: * individuals with medical conditions that may affect their ability to complete the work, such as recurrent muscle, bone, tendon, and ligament injuries, or a history of prior lower extremity surgery.

Keywords: foam roller kinesiotaping dynamic warm up performance