Kornimate/medical-research-clean huggingface dataset:
immunogenicity and safety study of 15-valent pneumococcal conjugate vaccine in 2-month-old and 3-month-old healthy volunteers

Conditions: Pneumonia, Pneumococcal

Summary: the purpose of this study is to evaluate immunogenicity and safety of 15-valent pneumococcal conjugate vaccine in healthy volunteers aged 2 and 3 months.


Eligibility criteria:
inclusion criteria: * aged above 2 months (minimum to 6 weeks), term (37-42 weeks gestation) and birth weight ≥2.5 kg. * the guardian understands the vaccination and research procedures, volunteers to participate in the research and sign the informed consent. * the guardian can follow the clinical research program, will be able to follow up until 3 years after booster immunization and have the ability to use thermometers, scale and fill in diary and contact cards as required. * there was no history of other live vaccines in the past 14 days and no history of other inactivated vaccines in the seventh day. * subaxillary body temperature \<=37.0 c. * determine health based on medical history, physical examination, and researcher's judgment. exclusion criteria: * have been vaccinated a listed or experimental pneumococcal vaccine. * history of invasive diseases caused by streptococcus pneumoniae confirmed by bacterial culture in the past. * in the past, there was any history of vaccination or serious allergy to drugs. in the past, fever of over 39.5 c related to vaccination occurred in biological products for vaccination and prophylaxis. * history of convulsion, epilepsy, encephalopathy and psychiatry or family history. * had abnormal labor (dystocia, device midwifery), history of asphyxia rescue and nerve organ damage. * history of pathological jaundice confirmed by diagnosis. * a history of thrombocytopenia or other coagulation disorders with definite diagnosis. * human serum gamma globulin injection after birth. * there are known or suspected immunological abnormalities, including immunosuppressive therapy (radiotherapy, chemotherapy, corticosteroids, antimetabolites, cytotoxic drugs), hiv infection, etc. * congenital malformations, severe malnutrition, developmental disorders, genetic defects (e.g. broad bean disease). * severe chronic disease, infectious disease, active infection, liver disease, kidney disease, cardiovascular disease, malignant tumor. * severe asthma. * systemic rash, dermatophytes, skin pus or blister. * participation in other drug clinical trials. * anything that the researcher considers likely to affect the evaluation of the study.
two-day bed rest, insulin sensitivity and muscle protein synthesis

Conditions: Healthy

Summary: the impact of two days bed rest versus two days of habitual activity on insulin sensitivity and cumulative muscle protein synthesis will be investigated in healthy young males

to study the mechanisms underlying inactivity-induced muscle atrophy, the impact of two days bed rest versus two days of habitual activity on insulin sensitivity and cumulative muscle protein synthesis will be investigated in healthy young males

Eligibility criteria:
inclusion criteria: * male * aged 18-40 exclusion criteria: * smoker * any diagnosed metabolic impairment (e.g. type 1 or 2 diabetes) * any diagnosed cardiovascular disease (e.g. deep vein thrombosis or hypertension) * chronic use of any prescribed or over the counter pharmaceuticals (that may modulate muscle protein metabolism). * a personal or family history of thrombosis, epilepsy, seizures or schizophrenia. * any known disorders in muscle metabolism * regular use of nutritional supplements (i.e. ingestion more than twice per week during the last month) * metallic implants (including heart pacemaker, cochlear implants, medication pumps, surgical clips, plates or screws). * allergy to lidocaine * recent (within the last 6 months) or current musculoskeletal injury (e.g. leg fracture)
phase ll study of hec585 in patients with ipf

Conditions: Idiopathic Pulmonary Fibrosis

Summary: a phase ll study to evaluate the efficacy and safety of various doses of hec585 tablets in patients with idiopathic pulmonary fibrosis


Eligibility criteria:
inclusion criteria: * volunteer to participate in this clinical study and sign the icf before the study begins; * aged 40-80 (including 40 and 80) ; * female or male subjects with child-bearing potential who agree and promise to take effective contraceptive measures; * diagnosed with ipf according to the official ats/ers/jrs/alat clinical practice guideline for ipf diagnosis (2018); * fev1/fvc ≥ 0.7; * fvc ≥ 45% predicted; * dlco corrected for haemoglobin (hb) ≥ 30% predicted of normal; * in the opinion of the investigator, subjects are willing and able to comply with the protocol requirements and attend the visit. exclusion criteria: * in the opinion of the investigator, subjects underwent significant deterioration in ipf within one month before randomization; * interstitial lung disease caused by other known causes; * any bacterial, viral, parasitic or fungal infection that needs to be treated at screening; * expected to receive lung transplantation during the study; * expected survival is less than 6 months; * history of tumors within 5 years before screening (except for localized cancers such as basal cell carcinoma); * moderate to severe hepatic insufficiency (child-pugh grade b or c, see appendix 4); * history of unstable or worsening heart disease within 6 months before screening; * cannot perform 6mwt or pft; * allergic to any component of hec585 tablets or pirfenidone tablets; * participated in other clinical study and received the last dose within 3 months before screening; * pregnant or breastfeeding; * history of smoking within 3 months before screening or are unwilling to quit smoking during the study; * subjects often drink alcohol within 6 months before the screening (drink more than 21 units of alcohol a week), or refuse to reduce alcohol intake during the study; * history of drug abuse within 6 months before the screening; * family or personal history of qt prolongation syndrome; * any condition that, in the opinion of the investigator, would compromise the safety or compliance of the subject, or prevent the subject from completing the study. * tbil \> 1.5 × uln or ast or alt \> 2 × uln; * clcr \< 50 ml/min; * human immunodeficiency virus (hiv) antibody is positive; * uncontrolled hepatitis b virus infection or hepatitis c virus infection; * qtcf \> 480 ms. * subjects have received any of the following treatments within 28 days before randomization: 1. any cytotoxic drug or immunosuppressant 2. therapeutic drugs for ipf, including but not limited to pirfenidone, nintedanib, prednisone at \> 15 mg/d or other glucocorticoids of the equivalent dose, n-acetylcysteine at \> 600 mg/d. 3. moderate and strong inhibitor or strong inducer of cyp1a2. 4. strong inducers or strong cyp3a4 inhibitors.
photobiomodulation and platelets rich in growth factors (prgfs)-assisted flap surgery in treating stage iii periodontal defects

Conditions: Periodontal Diseases

Summary: stage 3 periodontitis is a condition marked by swift and severe destruction of periodontal tissues. to effectively regenerate osseous defects resulting from periodontal disease, it is crucial to leverage the intrinsic regenerative potential of the periodontium via meticulously formulated therapeutic strategies

the main treatment methods of periodontal diseases involve scaling and root planning (srp), and periodontal surgery. periodontopathogens, can penetrate deep by crossing the epithelial barrier which may be difficult to be remove by nonsurgical periodontal therapy (nspt) alone. a multitude of grafted and non-grafted approaches have been used in the management of intra-bony defects. however, they do not provide predictable periodontal regeneration. a systematic review on the use of platelet-rich fibrin (prf) for managing periodontal defects highlights its promising potential in periodontal regeneration. it forms a fibrin matrix that promotes angiogenesis and enhances healing at defected sites. the review emphasizes prf's ability to sustain the release of growth factors, which are crucial for osteoblastic proliferation, migration, and adherence. this makes prf an effective scaffold for cellular elements, facilitating periodontal tissue regeneration. laser photobiomodulation (pbm) has emerged as a promising adjunctive treatment as it stimulates cellular processes, enhancing the natural regenerative capabilities of periodontal tissues. recent studies have demonstrated that pbm, particularly with diode, significantly improves clinical outcomes when combined with conventional periodontal treatments. it promotes osteoblastic proliferation, migration, and adherence, thereby facilitating bone regeneration and reducing periodontal pocket depth. additionally, pbm enhances angiogenesis and modulates the release of growth factors, creating an optimal healing environment.

Eligibility criteria:
inclusion criteria: * patients with ppd =5 mm and clinical attachment loss of ≥3 mm; * presence of 2 walled or 3 walled infra-bony defects posterior segments; * evidence of ≥3 mm of intra-bony defect depth evaluated by the visualization of peri-apical radiographs. exclusion criteria: * patients requiring antibiotic prophylaxis before the periodontal examination; * patients diagnosed with malocclusion at the site of the defect; * patients with systemic disease and/or on drugs that contraindicate periodontal surgery; * patients with a history of smoking and pan chewing; * sites with advanced class ii \& iii furcation involvement.

Keywords: photobiomodulation laser therapy prf stage iii periodontal diseases
gemcitabine or gemcitabine plus docetaxel after cisplatin, etoposide and radiation in non small cell lung cancer (nsclc)

Conditions: Non-small Cell Lung Cancer

Summary: to assess the 2 year survival of patients with stage iii unresectable non-small cell lung cancer receiving consolidation gemcitabine or gemcitabine plus docetaxel following concurrent chemotherapy and radiation.


Eligibility criteria:
inclusion criteria: * histologic or cytologic proof of single primary non-small cell lung cancer * no prior chemotherapy or radiation therapy * no prior malignancy exclusion criteria: * pregnancy or breastfeeding * serious concomitant systemic disorder * unintentional weight loss greater than 10%
pulmonary vein isolation using stereotactic radiotherapy system for the treatment of refractory atrial fibrillation

Conditions: Atrial Fibrillation

Summary: the study aims to investigate the short-term (3 months) and intermediate-term (12 months) safety and preliminary efficacy of stereotactic radiotherapy for pulmonary vein isolation to treat refractory atrial fibrillation.

this is a single center, single arm, prospective and phase 1 clinical trial. patients with refractory atrial fibrillation (af) will receive single fraction stereotactic radiotherapy for pulmonary vein isolation. to minimize the potential risks associated with this innovative technique, the study has been designed in a stepwise dose escalation fashion under carefully observation by the investigators. the dose escalation is guided by 3+3 algorithm to ensure more patients will be spared dose limiting toxicities and more patients will be entered on the dose level than will be chosen as optimal dose of maximal effects. low dosing levels with established safety profile will first be applied before administering higher dosing levels based on preclinical studies. safety is the primary endpoint of the study. safety will be assessed by incidence and evaluation of any serious adverse evens using ctcae v5.0 criteria associated with the procedure through 90 days (short-term) and 12 months (intermediate term). efficacy will be evaluated by assessing atrial fibrillation recurrence (for paroxysmal af) or af burden (for persistent af) after 90 days of blank period until 12 months post-treatment.

Eligibility criteria:
inclusion criteria: paroxysmal or persistent atrial fibrillation. age 55-89 symptomatic, refractory to at least 3 antiarrhythmic drugs failure from the previous catheter ablation of atrial fibrillation, or contraindicate /unwilling to undergo catheter ablation. anticoagulation for at least 3 months if cha2ds2-vasc 2 or more. exclusion criteria: with concomitant atrial flutter, wpw syndrome or supraventricular tachycardia. with sustained ventricular tachycardia. with sick sinus syndrome or atrioventricular block fulfilling the indication of permanent pacemaker implantation. stroke or myocardial infarction within 8 weeks. uncontrolled heart failure or unstable angina pectoris. severe structral heart diseases. severe pulmonary hypertension. uncontrolled hypertension. severe respiratory disease. esophageal ulcer. intracardiac thrombus by tee. pregnancy or have a preganancy plan. others.
optimal ecmo flow in the critical phase of cardiogenic shock to optimize peripheral organ perfusion and myocardial stress

Conditions: Cardiogenic Shock

Summary: veno-arterial ecmo (va ecmo) is considered the ultimate lifesaving technique in refractory cardiogenic shock (cs). however, va ecmo is associated with potentially serious adverse effects and complications. many authors have demonstrated that va ecmo increases left ventricular (lv) afterload, leading to increased lv stress, left ventricular end-diastolic pressure (lvedp), and left atrial pressure (lap). this pressure increase frequently results in pulmonary oedema and higher myocardial oxygen consumption. these complications are critical to patient survival and myocardial recovery and can lead to prolonged hospital stays and increased healthcare costs. in the absence of clinical studies and strong recommendations, the optimized management of va ecmo in clinical practice involves finding an ecmo flow that balances adequate organ perfusion with preserved ventricular ejection, while minimizing lv stress. since the optimal flow changes with myocardial recovery, ramp tests are regularly performed to adjust ecmo flow. to date, the optimized management of va ecmo has been guided empirically. the aim of this study is to describe the consequences of variations in va ecmo flow during the critical phase of cardiogenic shock on peripheral organ perfusion and lv stress. by analyzing the relationships between va ecmo flow rate, peripheral perfusion, and myocardial stress, investigators aim to optimize flow settings-particularly by minimizing the potential complications of va ecmo. during the daily ramp tests, investigators plan to collect hemodynamic data (cardiac output, svo₂, pulse pressure, etco₂, vasopressor and inotrope dosing), echocardiographic measurements, and organ perfusion indicators (nirss, co₂ gap, respiratory quotient, lactate levels). data will be collected on day 1 (ecmo initiation), day 2 (24 hours after ecmo initiation), and day 3 (48 hours after ecmo initiation).


Eligibility criteria:
inclusion criteria: * cardiogenic shock * treated with va ecmo for less than 48hours exclusion criteria: * ecmo initiated for refractory cardiac arrest * cardiac arres prior to the cardiogenic shock with low-flow \> 30 min * noradrenaline dose \> 1μg/kg/min, vasopressin dose \> 2iu/h, dobutamine dose \> 15μg/kg/min, adrenaline dose \> 1μg/kg/min, or unstabilized vasopressors or inotropes * post-cardiotomy cardiogenic shock * septic shock * left ventricular unloading by impella (cp/5) or atrioseptostomy * atrial septal defect * ventricular septal defect * pregnant or breast-feeding women * patients protected by law (under guardianship or curatorship), * patient participating in another research study with an exclusion period still in progress * opposition to participation after having been informed * patient not affiliated to any health care system * patient unable to express non-opposition without available trusted person

Keywords: ecmo optimal flow cardiogenic shock echocardiography organ perfusion myocardial recovery human adult left ventricular overload
taliderm dressing for venous ulcers

Conditions: Venous Stasis Ulcers; Venous Insufficiency

Summary: the study will test a new wound healing dressing called taliderm® on leg ulcers caused by chronic venous insufficiency (cvi). some people with cvi have poor vein circulation that causes ulcers to develop on the lower legs. this new dressing is hoped to help the ulcers heal more quickly. the study hypothesis is to determine whether the talidermr wound dressing, a poly-n-acetyl glucosamine (pglcnac) derived membrane material expedites wound healing in humans with venous stasis ulcers.


Eligibility criteria:
inclusion criteria: * adults ≥45 years of age * diagnosis venous partial thickness ulcer diagnosed within the past * 4 weeks without recent enzymatic, autolytic or chemical treatment * viable and clean wound bed with granulation tissue and ≥ 90% free of necrotic debris * wound measures between 5 and 20 cm2 * extends through epidermis and into the dermis exclusion criteria: * full thickness ulcers extending beyond the dermis * current wound, skin, or systemic infection * wound bed ≤90% free of necrotic debris * recent treatment with enzymatic, autolytic or chemical agents * history or collagen vascular disease, severe arterial disease, organ transplant, charcot, sickle cell * insufficient blood supply to ulcer (ankle-brachial index \ 1.3) * history of radiation therapy to the site * cellulitis/osteomyelitis/avascular ulcer bed * currently receiving hemodialysis * pregnancy * currently receiving treatment with another investigational drug or device or within the past 30 days * unable to comply with the study protocol
tavns or tms or both for depression

Conditions: Depression

Summary: the purpose of the research is to test out a combined treatment for depression where the investigators stimulate a nerve in the ear while at the same time stimulate the brain with magnets. these treatments are called transcutaneous (through the skin) auricular (ear) vagus nerve stimulation (tavns) and transcranial (through the skull) magnetic stimulation (tms). for participants who already have a cervical vns device, the investigators will not change their treatment and will use this in place of the tavns. the investigators think this combined method might treat depressive symptoms better than either alone. this study is in person at the institute of psychiatry in downtown charleston on the musc campus. first, participants will have a screening session and then will have 6 treatment days total where participants will receive either vns treatment alone, tms treatment alone, or both at the same time. the treatment that participants start with will be randomized, and they will have 2 treatment days of each combination.


Eligibility criteria:
inclusion criteria: * 18-75 years old * undergoing cervical vns or have tried and failed two antidepressant medications in the current episode * able to provide informed consent * english speaking and can read and write * 17-item hamilton depression rating scale (ham-d) score ≥20 * not responding to talking therapy. exclusion criteria: * preexisting neurological disorders, or dementia * history of major head trauma * life expectancy \<1 year * any type of cognitive impairment that would require approval/signature of a legal guardian/representative for participation * a score of \>2 on question 3 of the hamilton depression rating pertaining to suicidality * current active suicidal intent or plan, prior attempt within the last 6 months, or who in the judgment of the investigator would be at elevated risk for suicide will be excluded * patients who are pregnant will also be excluded. we will require a pregnancy test for individuals of child-bearing potential.
restore@home: feasibility study of a 12-week multidisciplinary telehealth rehabilitation programme for survivors of upper gastrointestinal (ugi) cancer

Conditions: Oesophageal Cancer; Gastric Cancer

Summary: feasibility study of a 12-week multidisciplinary telehealth rehabilitation programme for survivors of upper gastrointestinal (ugi) cancer

a single arm feasibility study will be conducted to examine the feasibility of delivering the 12-week restore programme (aerobic and resistance physiotherapy led-exercise, 1:1 dietary counselling and group education sessions) via telehealth to a cohort of upper gastrointestinal cancer survivors.

Eligibility criteria:
inclusion criteria: * be ≥ three months post oesophagectomy, total gastrectomy * ± neo-adjuvant/adjuvant chemo/chemoradiotherapy with curative intent * adjuvant therapy must be completed * access to home broadband exclusion criteria: * ongoing serious post-operative morbidity * evidence of active or recurrent disease. in addition those with any serious co-morbidity that would impact on exercise participation will be excluded including those with; * uncontrolled hypertension (resting systolic blood pressure \>180mmhg and/or diastolic \>100mmhg) * recent serious cardiovascular events (within 12 months) including, but not limited to cerebrovascular accident, and myocardial infarction * unstable cardiac, renal, lung, liver or other severe chronic disease * uncontrolled atrial fibrillation * left ventricular function \<50%.
contingency management for attendance - 2

Conditions: Substance Abuse

Summary: the purpose of this study is to evaluate the effectiveness of a low-cost contingency management procedure as compared to standard treatment. using a cross-over design, cm is implemented at different community-based clinics and compared with non-cm in the same facilities. research staff collects information regarding patients' demographic characteristics, attendance, and outcomes at the clinics. during phase a (non-cm), standard clinical practice is in place. during phase b (cm), all patients have the chance to win prizes by coming to treatment. each participating clinic is randomly assigned to receive either the a or b phase first; each phase is in effect for 16 weeks.


Eligibility criteria:
subjects will be patients in treatment at one of the participating clinics during the study period. there are no other inclusion or exclusion criteria because we wish to make enrollment open to increase generalizability.

Keywords: contingency management substance abuse treatment