Kornimate/medical-research-clean huggingface dataset:
transcutaneous electrical nerve stimulation for labor pain control

Conditions: Labor Pain

Summary: transcutaneous electrical nerve stimulation (tens) is a non-invasive electro-physical modality used for several pain conditions including labor pain control. despite several years of research, there is still no agreement within the literature regarding the selection of tens parameters. it is aimed to investigate two types of tens frequencies (tens1 alternating between 4 to 100 hz and tens2 alternating between 80 to 100 hz) compared to sham-tens.

midwives and the study investigator will ask parturients, who are admitted to the labor ward at region hospital herning satisfying the inclusion and exclusion criteria, whether they are interested in attending the experimental session. the study will be conducted as soon as the subject is admitted at the labor ward. the study will only be conducted during early and active labor and not during the birth of the baby. the subject in this study includes the package of a parturient and her neonate (after birth) as we also obtain data about the neonate. hereby, two consent forms will be obtained. as this study is a non-invasive study, it is decided to have at least the consent of one parent. the investigator will fill out a questionnaire about the parturient in cooperation with the subject and midwife, including screening questions related to inclusion and exclusion criteria before the experimental session starts. the study will last approximately one hour and will be conducted during laboring circumstances. kt (kenoja thuvarakan) will carry out the experiment, and she will be present in the delivery room during the whole session. the study includes several outcomes, including subjective and semi-objective pain measures. the primary outcome is vas (0-10 cm scale), while secondary outcomes include ppt and satisfaction questionnaire (only at the end of the study). the subjects will be asked before, and immediately after the experimental exposure about the four outcomes (vas and ppt). the subjects will be exposed to one of the two combinations of tens stimulation (low and high alternating frequency), which will be compared to sham-tens.

Eligibility criteria:
inclusion criteria: * singleton pregnancy * between ages 18-39 years * vertex presentation * speak, read and understand danish * at term (37-42 weeks gestation age) exclusion criteria: * high-risk pregnancies (including risk factors: eclampsia, pre-eclampsia, diabetes, gestational diabetes, hypertension, and hypotension, intrauterine growth restriction, polyhydramnios, and oligohydramnios). * pre-gestational body mass index above 40 kg/m2 * use of fetal-scalp electrode during the experiment * use of pacemakers and other electronic implants * severe arrhythmia * present musculoskeletal/neurological illnesses * chronic pain within last 6 months * present medicated mental disorders * dermatological disorders * use of other long-acting pain relief * use of tens 48 hours before the trial * drug addiction defines as the use of cannabis, opioids, or other drugs. * smokers * lack of ability to cooperate

Keywords: tens labor pain childbirth rct pilot study
comparative effects of cervicothoracic junction mobilization and thoracic manipulation in subachromial impinegment syndrome

Conditions: Subacromial Impingement Syndrome

Summary: the aim of this study is to investigate the comparative effects of high velocity low amplitude thrust manipulation of upper thoracic spine and spinal mobilization with arm movement on the subjects with the subacromial impingement syndrome.

subacromial impingement is the condition, in which the tissue underlying subacromial spaces are compressed between the head of the humerus and the acromion, is one ofthe main diagnoses of shoulder pain. subjects frequently experience pain when engaging in anyoverhead activity.in general, medical practice, pain in the glenohumeral region is commonmusculoskeletal problem has almost 48% prevalence. cervicothoracic junction refers to atherapeutic technique or manual therapy approaches that focuses on improving mobility andfunction in this area where the cervical neck and upper back spine meet. upper thoracic manipulation refers to a manual technique used to address dysfunctions or restrictions in the upper portion of the thoracic vertebral region, which is the area of the thoracic vertebrae located between the cervical and mid back regions.previously, studies were conducted individually to determine effectiveness of upper thoracic mobilization and cervico-thoracic mobilization with arm movement for treatment of subacromial bursitis. however, fewer studies were previously conducted to compare the effects of both treatment methods (mobilization and manipulation). this study specifically focuses on the comparative effects of upper thoracic and cervico-thoracic mobilization.

Eligibility criteria:
inclusion criteria: * age ranging from 18-40 * both males and females * positive hawkins and neer's impingement test positive * the subjects primarily report unilateral shoulder pain. exclusion criteria: * patients with diagnosed case of co morbidities such as malignancies, ra, or fracture, that causes bilateral shoulder discomfort. * diagnosed case of cervical radiculopathy, glenohumeral osteoarthritis, and adhesive capsulitis

Keywords: shoulder pain neck pain upper thoracic mobilization cervicothoracic mobilization subacromial impigement syndrome
a long-term safety study of tirzepatide (ly3298176) in participants with type 2 diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to determine the long-term safety of the study drug tirzepatide in combination with oral antihyperglycemic medications in participants with type 2 diabetes.


Eligibility criteria:
inclusion criteria: participant must: * have been diagnosed with type 2 diabetes mellitus based on the world health organization classification before the screening visit. * have hba1c ≥7.0% to \<11.0%, as determined by the central laboratory at screening. * have been taking sulfonylureas, biguanides, thiazolidinedione, alpha-glucosidase inhibitor, glinides, or sodium-glucose cotransporter type 2 inhibitor monotherapy for at least 3 months before screening and have been on the following dose for at least 8 weeks before screening. * have body mass index (bmi) of ≥23 kilograms per meter squared at screening. * be of stable weight (±5%) during 3 months preceding screening; and agree to not initiate an intensive diet and/or exercise program during the study with the intent of reducing body weight other than the lifestyle and dietary measures for diabetes treatment. exclusion criteria: participant must not: * have type 1 diabetes mellitus. * have had chronic or acute pancreatitis any time prior to study entry. * have proliferative diabetic retinopathy or diabetic maculopathy or nonproliferative diabetic retinopathy requiring immediate or urgent treatment. * have disorders associated with slowed emptying of the stomach, or have had any stomach surgeries for the purpose of weight loss. * have acute or chronic hepatitis, signs and symptoms of any other liver disease, or blood alanine transaminase (alt) enzyme level \>3.0 times the upper limit of normal (uln) for the reference range, as determined by the central laboratory. participants with nonalcoholic fatty liver disease (nafld) are eligible for participation in this trial only if there alt level is ≤3.0 the uln for the reference range. * have had a heart attack, stroke, or hospitalization for congestive heart failure in the past 2 months. * have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2. * have been taking weight loss drugs, including over-the-counter medications during the last 3 months.
long term results of the canadian breast imrt study

Conditions: Breast Cancer

Summary: women diagnosed with an early stage cancer of the breast usually have the cancer removed by lumpectomy and then have radiation treatments to the entire breast. in 2008 the investigators published the result of a multicentre study showing that breast intensity modulated radiation therapy (imrt) significantly reduces the occurrence of radiation burns. in this study the investigators will recall all patients at 8 years to assess if this technique also reduces permanent side effects including pain and cosmesis.

in 2008 our group published the results of a multicentre, randomized, double-blinded study comparing standard radiotherapy to breast imrt. the study showed a significant reduction moist desquamation using breast imrt from 47.8% to 31.2% (p=0.002). there are two other phase iii trials showing improvement of long term cosmetic outcomes. yet the use of breast imrt remains not widely accepted. this trial aims at evaluating long term tolerance of breast imrt compared to standard radiotherapy. the investigators hypothesize that breast imrt reduces the occurence of chronic breast pain (primary objective), improves cosmesis, reduces the occurence of delayed and permanent radiation induced skin side effects (telangiectasia, dryness, induration, edema, discolorations), improves quality of life. the investigators also hypothesize that there will not be differences in the local control rate or survival.

Eligibility criteria:
inclusion criteria: * patients treated in the canadian phase 3 randomised controlled trial breast imrt trial exclusion criteria: * patients declining participating to this study * patients unable to travel to the study site * patients deceased

Keywords: breast cancer radiotherapy imrt
rapid and accurate detection of major mycobacterium species in pulmonary infection based on genseizer platform

Conditions: Mycobacterium Pulmonary Infection

Summary: comparison of rapid detection methods of mycobacterial pathogens, genseizer v.s. pcr reverse hybridization.

the investigators developed a new platform called genseizer, which combines bioinformatics analysis of a large dataset with multiplex pcr-based targeted gene sequencing, to identify eleven major mycobacterium species implicated in human disease. simultaneous detection of certain antibiotic resistance genotypes, i.e., erm(41) and rrl in m. abscessus, is also feasible. this platform detected both reference strains and clinical isolates with a high degree of specificity and sensitivity. in this study, the investigators plan to verify the detection efficiency of genseizer in clinical samples (sputum, alveolar lavage fluid) and compare it with existing methods on the market (pcr reverse hybridization) and gold standard method (target sequencing after incubation)

Eligibility criteria:
inclusion criteria: * suspected cases of mycobacterial lung infection exclusion criteria: * no sputum * refused or unable to tolerate bronchoscopy
evm16 injection as a single and combination with tislelizumab in solid tumors

Conditions: Advanced or Recurrent Solid Tumors

Summary: the goal of this clinical trial is to learn the side effects, safety and effect of a tumor vaccine (evm16) alone or in combined with an anti-pd-1 antibody (tislelizumab) . this clinical trial will include solid tumor patients who failed standard treatment. the main questions to answer are: safety of evm16. suitable dose of evm16. effects of evm16 combined with tislelizumab.


Eligibility criteria:
key inclusion criteria: * recurrent or metastatic solid tumors that have been histologically or cytologically pathologically confirmed and are not amenable to radical treatment with surgery or local therapy. * patients with advanced or recurrent solid tumors who have failed prior standard therapy. * expected survival period \>6 weeks at the time of informed consent. * adequate organ function * eastern cooperative oncology group (ecog) physical status score 0 to 1. * is willing to provide archival or fresh tumor tissue samples for evm16 production. * has adequate treatment washout period prior to first study dose. * has at least one measurable lesion as assessed by the investigator according to recist version 1.1 criteria before enrollment. key exclusion criteria: * primary central nervous system (cns) malignancies that are symptomatic, untreated, or in need of curative treatment, or subjects with cns metastases. * uncontrolled co-morbidities. * cerebrovascular event (stroke, transient ischemic attack, etc.) within 4 months prior to the signing of inform consent form. * in screening period male qtcf interval \>450 ms; female qtcf interval \>470 ms (calculated by the fridericia formula). * left ventricular ejection fraction (lvef) \< 50% during the screening period. * diagnosis of immunodeficiency, or history or syndrome of active as well as former autoimmune disease with risk of relapse, or a disease requiring systemic steroid hormone or immunosuppressive drug therapy. * subjects with a history of positive human immunodeficiency virus (hiv) test or acquired immunodeficiency syndrome (aids). * co-infection hbv and hcv. * presence of any active infection requiring systemic therapy. * patients who are still on any other investigational medications treatment at the time of screening. * previous treatment with cell therapy, tumor vaccines, cytokines, or growth factors for cancer control. * patients with prior intolerance to tislelizumab resulting in permanent termination of tislelizumab. * history or presence of significant lung disease.

Keywords: solid tumor tumor vaccine immune checkpoint inhibitor
asd-specific induced pluripotent stem cells for disease modeling

Conditions: Autism Spectrum Disorder

Summary: specific aims: 1. to generate induced-pluripotent stem cells (ipscs) from peripheral blood mononuclear cells (pbmcs) isolated from whole blood of asd probands and healthy controls. 2. to derive neural progenitor cells (npcs) and neurons from ipscs of asd probands and healthy controls and compare differences between patients and healthy controls to investigate the cellular phenotype of asd and uncover the pathophysiology of the disease.

autism spectrum disorders (asds) is a common, lifelong impairing childhood-onset neurodevelopmental disorder with clinical and genetic heterogeneity. the etiology of asd is complicated and remains largely unknown. evidences indicate the high heritability (54-77%) in asd, and researchers also found copy number variations (cnvs) play an important role in the etiology of asd. however, due to the ethical issue, researchers haven't had an appropriate platform to investigate the copy number change effect to date. in the following study, researchers are going to derive asd-specific induced pluripotent stem cells and neurons for disease modeling. 10 asd patients and 10 healthy controls will be included in the present study and ipscs and neurons will be generated from their pbmcs. electrophysiological recording and analysis of neuronal morphology will be conducted to reveal the cellular phenotype of asd after comparing differences between patients and healthy controls. the study will provide a platform to reveal the etiology of genetic basis and molecular mechanism of asd. the cellular phenotype of asd will be revealed by comparing differences between patients and healthy controls. the findings from this work are expected to contribute to the basic and clinical research on asd.

Eligibility criteria:
inclusion criteria: * asd group: subjects who met the diagnostic criteria of either autistic disorder or asperger's disorder defined by the dsm-iv criteria. exclusion criteria: * td group: subjects with any current or lifetime dsm-iv psychiatric disorders.
efficacy and safety of al-001 ophthalmic injection in subjects with wamd

Conditions: Wet Age-related Macular Degeneration (wAMD)

Summary: this phase ii study is designed to evaluate the efficacy and safety of al-001 ophthalmic injection in patients with wet age-related macular degeneration. eligible patients, who meet the inclusion/exclusion criteria and have shown an anatomic response to an anti-vegf (vascular endothelial growth factor) injection, will be randomized in cohorts 1 and 2 to receive al-001 administered via suprachoroidal space injection, cohort 3 to receive aflibercept.


Eligibility criteria:
inclusion criteria: 1. age≥ 50 and ≤ 85. 2. the study eye was diagnosed with subfoveal active choroidal neovascularization (cnv) lesions secondary to wamd. 3. the study eye has response to anti-vegf injections. 4. the subject or their legal representative agrees to participate in this study and signs a written icf. exclusion criteria: 1. non-wamd induced cnv or macular edema in the study eye. 2. non-wamd induced eye conditions that may affect central vision or medical history that may seriously affect central vision in the study eye. 3. uncontrolled glaucoma in the study eye. 4. history of vitreoretinal surgery, antiglaucoma trabeculectomy, or other anti-glaucoma filtering surgery in the study eye. 5. refractive interstitial opacity that significantly affects visual function assessment or fundus examination in the study eye. 6. ametropia (high myopia or high hyperopia) \> 8.0d in the study eye, or significant posterior scleral staphyloma in the study eye. 7. malignant tumor in any eye, including but not limited to eye lymphoma or choroidal melanoma. 8. none of intraocular inflammation in the study eye. 9. other conditions that may affect compliance or may not be suitable to participate in this trial in the opinion of investigator.
study of sacituzumab govitecan-hziy versus treatment of physician's choice in participants with hr+/her2- metastatic breast cancer

Conditions: Metastatic Breast Cancer

Summary: the primary objective of this study is to assess and compare the efficacy and safety of sacituzumab govitecan-hzi versus treatment of physician's choice (tpc) in participants with hormonal receptor-positive (hr+) human epidermal growth factor receptor 2 (her2-) negative metastatic breast cancer (mbc).


Eligibility criteria:
key inclusion criteria: * documented evidence of hormone receptor-positive human epidermal growth factor receptor 2 negative (her2-negative) (hormonal receptor-positive (hr+)/her2-) metastatic breast cancer (mbc) confirmed. * refractory to or relapsed after at least 2, and no more than 4, prior systemic chemotherapy regimens for metastatic disease: * at least 1 taxane in any setting. * at least 1 prior anticancer hormonal treatment in any setting. * at least 1 cyclin-dependent kinase inhibitor 4/6 in any setting. * eligible for one of the chemotherapy options listed in the tpc arm. * documented disease progression after the most recent therapy. * adequate bone marrow function (hemoglobin ≥ 9 g/dl, absolute neutrophil count (anc) ≥ 1,500 per mm\^3, platelets ≥ 100,000 per mm\^3). * adequate renal function: calculated creatinine clearance ≥ 30 ml/minute according to the cockcroft and gault formula . * adequate liver function (bilirubin ≤ 1.5 institutional upper limit of normal (iuln), or ≤ 3 iuln for individuals with documented gilbert's syndrome, aspartate aminotransferase (ast) and alanine aminotransferase (alt) ≤ 2.5 x iuln (in the case of liver metastases ≤ 5.0 x iuln)). * females must not be lactating or pregnant at screening or baseline (as documented by a negative beta human chorionic gonadotropin (ß-hcg)). key exclusion criteria: * previous treatment with topoisomerase 1 inhibitors as a free form or as other formulations. * history of significant cardiovascular disease or clinically significant electrocardiogram (ecg) abnormality. * active serious infection requiring antibiotics. * any medical or other condition which, in the opinion of the investigator, causes the individual to be medically unfit to receive sacituzumab govitecan or unsuitable for any reason. * locally advanced mbc (stage iiic) in individuals who are candidates for curative intent therapy at the time of study enrollment. note: other protocol defined inclusion/exclusion criteria may apply.
sicilian administrative data base study in acute coronary syndrome patients

Conditions: Acute Coronary Syndrome; Acute Myocardial Infarction

Summary: thi is an observational, non interventional, cohort analysis by using administrative databases (drugs treatment, laboratory and diagnostic tests, specialist visits and hospitalizations) of sicilia region to evaluate treatment patterns of patients after acute coronary syndrome (acs) event.

health-db acs

Eligibility criteria:
inclusion criteria: * subjects discharged alive from hospitalization for acs exclusion criteria: * all patients that don't have a continuative presence as beneficiaries of the region between january 1st, 2007 and december 31st 2011 will be excluded from analysis.

Keywords: acs ami
study to evaluate jcxh-211 as monotherapy in patients with malignant solid tumors

Conditions: Cutaneous Tumor; Malignant Solid Tumor

Summary: : a phase 1 open-label study to evaluate the safety, tolerability and efficacy of jcxh-211 intratumoral injection in patients with malignant solid tumors

the main purpose of this study is to find out how safe and tolerable the study drug, jcxh-211, is and also how well it works in people with malignant solid tumors. the study drug jcxh-211, is an immunotherapy drug. this means that it aims to work by boosting immune system's response to tumors, to help fight against the growth of the cancer cells. the study has 2 main phases: phase 1a and phase 1b. phase 1a has 2 stages, skin/subcutaneous lesions stage, deep (visceral) lesions stage. phase 1b will not start until all the data collected in phase 1a has been completed and reviewed to check that it is safe and well tolerated.

Eligibility criteria:
inclusion criteria: * male or female patients 18-75 * patients with malignant solid tumors that have been diagnosed by pathology and/or cytology * patients who have progressed on or who cannot tolerate available therapies or for whom curative therapy does not exist * patients with at least one non-injected measurable tumor lesion per recist v1.1 * patients with lesions suitable for intratumoral injection (the lesion length is at least 10mm and not exceeding 80mm) * patients enrolled in the skin/subcutaneous lesions and deep （visceral） lesions stages of phase ia must agree to provide pre- and post-treatment tumor biopsy tissues * patients must have adequate organ and marrow functions * patients with treated brain metastases are eligible if meeting protocol's requirement * patients must be ≥ 4 weeks beyond treatment with any chemotherapy (6 weeks for nitrosoureas or mitomycin c), hormonal, biological, targeted agents, other investigational therapy or radiotherapy exclusion criteria: * patients who have received prior il-12 either alone or as part of a treatment regimen * patients who have received prior therapy with an immuno-oncology agent and were discontinued from that treatment due to a grade 3 or higher immune-related adverse event (irae) * patients requiring therapeutic doses of anticoagulation * patients with tumors that impinge on major airways, blood vessels, or nerve bundles * patients with a history of autoimmune disease that has the possibility of recurrence or active autoimmune disease that requires immunosuppressive medications * patients who had a major surgical procedure within 4 weeks prior to the first dose of study treatment * current or prior use of immunosuppressive medication within 2 weeks prior to the first dose of study treatment * patient with history of solid organ or allogenic bone marrow transplantation

Keywords: tumor intratumoral injection