Kornimate/medical-research-clean huggingface dataset:
pre-approval access with amivantamab (jnj-61186372) in participants with metastatic non-small cell lung cancer

Conditions: Metastatic Non-Small Cell Lung Cancer

Summary: the purpose of this expanded access program (eap) is to provide amivantamab for the treatment of participants with metastatic non-small cell lung cancer who have epidermal growth factor receptor exon 20 insertion mutations, and whose disease has progressed during or after current standard of care platinum-based chemotherapy. this intermediate eap may be considered for individuals with serious/life-threatening diseases or conditions, where there are no alternative treatments or where individuals have progressed following standard of care.


Eligibility criteria:
inclusion criteria: * has histologically or cytologically confirmed unresectable or metastatic non-small cell lung (nsclc) cancer with an epidermal growth factor receptor (egfr) exon 20 insertion (exon20ins), not amenable to curative therapy * has completed prior treatment with platinum-based chemotherapy. in the case of platinum ineligible participants, the participant may qualify if previously treated with an alternative treatment (example, an investigational or approved egfr exon 20 targeted tyrosine kinase inhibitor \[tki\], or see guidelines such as those from national comprehensive cancer network \[nccn\] or european society for medical oncology \[esmo\] for alternative non-platinum-based treatments) * life expectancy is projected to be greater than or equal to (\>=) 3 months with adequate hepatic, renal, pulmonary and cardiac function (physician assessed) exclusion criteria: * has medical history of interstitial lung disease (ild), including drug-induced ild or radiation pneumonitis requiring treatment with prolonged steroids or other immune suppressive agents within the last 3 months * has leptomeningeal disease that is active or symptomatic * symptomatic, unstable or untreated brain metastases (need to be resolved prior to participating in the program) * known allergies, hypersensitivity, or intolerance to amivantamab or its excipients or to other monoclonal antibodies * is pregnant or breastfeeding
intracervical lidocaine versus intramuscular diclofenac for pain relief in hsg in a tertiary hospital in kano

Conditions: Female Infertility of Tubal Origin

Summary: this study compares the effect of intracervical block with 1% lidocaine and intramuscular diclofenac 75mg in decreasing pain perception during hysterosalpingography. half of participants will receive intracervical block with 1% lidocaine, while the other half will receive intramuscular diclofenac 75mg.

hysterosalpingography (hsg) is a radiographic test to evaluate the contour of the uterine cavity and patency of the fallopian tubes after injection of a radio-opaque dye through the cervix. it is typically performed in the evaluation of infertility or to diagnose uterine anomalies. it is the most common method of tubal evaluation in the developing countries because it is cheap, readily available and requires less expertise. unfortunately, hsg can cause discomfort or pain for the patient during or after the procedure, and this evokes anxiety and fear for many patients. up to 72 % of women complain of significant discomfort with this test. lidocaine is a local anaesthetic which exerts its effect by altering neuronal depolarization by blocking the sodium channels in the cell membrane, thereby preventing transmission of the sensation of pain to the higher neurons. lidocaine is commonly used for infiltration and for peripheral nerve blocks if an intermediate duration is required. diclofenac is a non-steroidal anti inflammatory drug that reduce nociception which is related to inflammation and inflammatory mediators whether from trauma

Eligibility criteria:
inclusion criteria: * all women with infertility who will be undergoing a hysterosalpingography, and must have given consent will be recruited into the study exclusion criteria: * history of any allergies to local anaesthetics, radio-opaque dye, or anti-inflammatory medications * all patients with active pelvic inflammatory diseases * all patients with chronic pelvic pain * patients with history of cervical surgery * other indications for hysterosalpingography like ashermans syndrome, congenital uterine anomalies

Keywords: hysterosalpingography pain relief infertility intracervical block diclofenac
treatment of atrophic nonunion fractures by autologous mesenchymal stem cell percutaneous grafting

Conditions: Nonunion Fracture

Summary: bone fractures heal most of the time particularly well and without complications. the solidification takes rarely more than two to three months. the wound healing depends greatly on a good blood supply and needs several steps. these processes culminate in a new mass of heterogeneous tissue which is known as the fracture callus. unfortunately, 2%-5% bone fractures cannot achieve a proper solidification and between the ununited fragments a scar tissue appears. this incorrect healing induces pain and even infections. when this situation persists more than 6 months, it is referred to as nonunion fracture, which will require some form of intervention to stimulate the natural healing process of the body. first of all, good surgical techniques with stable immobilization should be applied and local infection should be excluded. then stimulation of the callus is required. cell therapy with bone marrow cells has emerged as a promising new approach for bone regeneration. animal studies as well as preliminary human studies have shown that mesenchymal stem cells, a particular kind of stem cells isolated from the bone marrow, could induce callus formation when injected in the nonunion site of a broken bone. in this study the investigators aim at determining whether mesenchymal stem cells (msc) isolated from the patient's bone marrow and injected in the nonunion site could be a safe and effective treatment for nonunion fractures. patients will be randomized in two groups; one injected with mesenchymal stem cell and the other injected with placebo. the investigators seek also to know how long it takes to develop the callus formation and whether there is a partial or a complete callus formation.


Eligibility criteria:
inclusion criteria: * male or female; female patients must use a reliable contraception method * age ≥ 18 years * fracture having no radiological callus after 6 months and absence of any hypertrophic bone reaction. * no sepsis * good skin covering * be able and willing to participate in the study * written informed consent exclusion criteria: * evidence of malignancy (except non-melanoma skin cancer) in the past five years * pregnancy or breastfeeding * patient positive by serology or pcr for hiv, hepatitis b or c infection * insufficient reduction of the fracture with displaced fragments * evidence of local sepsis by clinical signs, biological parameters (crp) and/or positive isotopic scan using indium-labelled leucocytes

Keywords: bone nonunion fracture atrophic nonunion fracture callus mesenchymal stem cells cell therapy autologous indium pet-scan
a study to evaluate the efficacy and safety of hlx15-iv versus darzalex® in combination with lenalidomide-dexamethasone (rd) in transplant-ineligible patients with newly diagnosed multiple myeloma

Conditions: Newly Diagnosed Multiple Myeloma

Summary: this is a randomized, double-blind, parallel-controlled, multicenter, phase iii study to compare the efficacy and safety of hlx15-iv in combination with rd (hlx15-iv-rd) versus darzalex® in combination with rd (d-rd) in patients with ndmm who are ineligible for autologous stem cell transplantation (asct).


Eligibility criteria:
inclusion criteria: 1. capable to understand and sign the icf. 2. patients aged ≥ 18 years . 3. patient must have documented multiple myeloma (mm) satisfying the international myeloma working group (imwg) diagnostic criteria for mm. 4. newly diagnosed, untreated and not considered candidate for autologous stem cell transplantation (asct). 5. patient must have an ecog performance status score of 0. 6. patient must have pretreatment clinical laboratory values. 7. contraceptive use by men or women should be consistent with local regulations. 8. a wocbp must have a negative serum pregnancy test at screening within 72 hours prior to randomization. exclusion criteria: 1. patient has a diagnosis of primary amyloidosis, monoclonal gammopathy of undetermined significance (mgus), smoldering multiple myeloma (smm), waldenström's disease, or other conditions in which igm m-protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions. 2. patient has plasma cell leukemia or poems syndrome . 3. patient has prior or current systemic therapy or asct for mm before randomization. 4. patient has peripheral neuropathy or neuropathic pain grade 2 or higher. 5. patient has a history of malignancy (other than mm) within 3 years before randomization . 6. patient has clinical signs of meningeal involvement of mm. 7. patient has known copd, persistent asthma, or a history of asthma within the last 2 years. 8. patient is known to be seropositive for history of human immunodeficiency virus (hiv) or known to have treponema pallidum antibodies (anti-tp). 9. patient is known to have active hepatitis b or c. 10. patient has any concurrent medical or psychiatric condition or disease that is likely to interfere with the study procedures or results. 11. patient has clinically significant cardiac disease. 12. patient has known allergies, hypersensitivity, or intolerance to treatment drugs. 13. patient has history of drug abuse or substance abuse. 14. patient is a woman who is pregnant, or breast-feeding, or planning to become pregnant or donate eggs (ova, oocytes). 15. patient had radiation therapy within 14 days of randomization. 16. patient had plasmapheresis within 28 days of randomization. 17. patient had major surgery within 28 days before randomization. 18. patient in clinical trials of any other drug or device within 3 months before randomization. 19. patient has any condition could prevent, limit, or confound the protocol-specified assessments.
acute effects of a non excitatory cardial stimulation

Conditions: CCM Implantation

Summary: electric stimulation by cardial contractility modulation (ccm)to improve contractility and physical capacity


Eligibility criteria:
inclusion criteria: * planned ccm implantation * systolic left ventricular dysfunction despite of adequate therapy of heart failure (nyha ii, iii, iv) * implanted pacemaker, defibrillator or pacemaker during cs intubation * written informed consent * open entryways exclusion criteria: * anemia hemoglobin (hb)\<8 mg/dl * lying coronary sinus (cs) tube or cs being not able to intubate * chronic atrial fibrillation or flutter * mechanic tricuspid valve prothesis * no access via subclavian vein * patients with vvi pacemaker being stimulated 110% * idiopathic hypertrophic cardiomyopathy, restrictive constrictive cardiomyopathy or heart failure because of known inflammatory or infiltrative illnesses or constrictive illness * acute myocardial ischemia presented by angina pectoris or ecg changes under load * patients being hospitalized because of heart failure during the last month and have to be treated with intravenous diuretics or inotropic substances * acute coronary syndrome should not be implanted for at least 3 month * patients with mechanic aortic or tricuspid valve * patients after heart transplantation * patients with clinical significant ectopy, defined by \> 8.900 pvcs during 24 hours at beginning holter monitoring * patients after hypertensive crisis * patients with acute renal failure * ejection fraction (ef) \> 35 * patients after left ventricular pacemaker electrode * pregnant or breast feeding women * patients with heart failure after sepsis
evaluating the impact of various dietary nitrate supplements on oral health

Conditions: Oral Health; Dietary Nitrate

Summary: this study aims to investigate the effects of different dietary nitrate supplements, versus placebo, on microbiological and immunological markers associated with oral health in people aged 18-65 years. the main research questions are: * how do different dietary nitrate supplements (beetroot crystals vs. beetroot juice) affect oral health markers, including salivary ph and oral microbiome composition? * what is the acceptability and ease of integrating one of dietary nitrate supplements, made from beetroot but processed as freeze dried crystals or juice, into the daily diet? to answer these questions, the study will compare results from three groups of participants, who will be randomly assigned to one of the following study arms: group 1: the control group will consume a placebo beetroot supplement completely free of nitrate in juice form. group 2: the beetroot juice group will consume a beetroot supplement standardised to contain \~ 400 mg of nitrate in juice form. group 3: the beetroot crystals group will consume a beetroot supplement standardised to contain \~400 mg of nitrate in freeze dried crystal form. the study will follow a randomised, single-blind, placebo-controlled, parallel design, and the intervention will last for four weeks. data will be collected by providing pre- and post-intervention saliva samples tongue swabs, and various questionnaires will be completed at baseline and at the end of the study. in addition, at the end of the second week of the intervention period, participants will be asked to collect a saliva sample over three consecutive days at home.


Eligibility criteria:
inclusion criteria: * healthy volunteers * aged 18 - 65 years. exclusion criteria: * aged less than 18 or more than 65 years old. * current smoking * alcohol consumption of greater than14 units per week. * diagnosis of a chronic disease (e.g., cardiovascular disease, diabetes, cancer, or gastrointestinal disorders), including oral diseases. * use of antibiotics within the past three months or medications/nutritional supplements that may affect the oral cavity (e.g., prebiotics, probiotics, or hormone replacement therapy). * regular use of antibacterial mouthwash or xylitol-containing products (e.g., gum or toothpaste) or the use of proton pump inhibitors. * presence of braces/invisalign or dentures. * known allergy to any food, including beets * adherence to dietary restrictions (e.g., weight loss diet) * eating disorders that may limit participation in the study. * currently pregnant, breastfeeding or trying to become pregnant. * participation in other studies.

Keywords: dietary nitrate oral health salivary acidity oral microbiome
nasopharynx microbiota component and in vitro cytokines production in coronavirus disease (covid-19)

Conditions: Covid19

Summary: the investigators will study nasopharunx microbiota composition, rna sequences and in vitro cytokines production by peripheral blood cells of covid-19 patients (both mild-moderate and severe cases) (comparing with convalescent patients and healthy controls).

the investigators will compare study parameters (basal) between mild-moderate and severe covid-19 patients and with other study groups (i.e. convalescent and healthy controls). nasopharunx microbiota dysbiosis, in vitro cytokines production profile, and peripheral blood flocytometric results of the four study groups will be compared. in vitro cytokines production will be studied and compared in nill (no antigens) and mitojen (cocktail of antigens) pre-prepared test tubes.

Eligibility criteria:
inclusion criteria: * ability to give a written consent exclusion criteria: * in ability to give a written consent * using of medications that affect the results of study parameters * presence of malignancy or tuberculosis
ascending-dose study to evaluate the safety, tolerability, pharmacokinetics of dc371739 single-dose treatment in healthy subjects

Conditions: Hyperlipidemia

Summary: this study is to evaluate the safety, tolerability, pharmacokinetics of dc371739 after a single-dose oral administration in healthy chinese subjects, and to explore the maximum tolerated dose, also the pharmacokinetics of urine and feces.

this is a randomized, double-blind , placebo-controlled, single-dose study in 43 male healthy subjects assigned to one of the six dose groups (30mg、50mg、100mg、 200mg、400mg and 600mg). 30mg dose group is the pilot group with 3 subjects. each of the other dose groups will include 8 subjects (7 for dc371739 and 1 for placebo). subjects will be admitted for treatment on day -1 and receive a single dose of study drug or placebo on day 1. subjects from different dose groups were enrolled in turn, the next dose group was conducted on the premise that the d6 safety evaluation was completed after the administration of the previous dose group with the result was tolerance. blood samples will be collected for each group after administration for pharmacokinetic data analysis. urine and feces were collected in three dose groups of 100 mg, 200 mg and 400 mg respectively to explore the pharmacokinetic characteristics of urine and feces.

Eligibility criteria:
inclusion criteria: 1. aged 18-40 years, inclusive, male; 2. weight≥50kg; body mass index of 19 to 26 kg/m2, inclusive; 3. based on the medical history, physical examination, clinical laboratory examination, 12-lead ecg and vital signs results, subjects with no evidence of active or chronic diseases, or clinically significant abnormalities; exclusion criteria: 1. subjects with a history of allergy to study drug ingredients or similar drug, with a history of allergic disease or allergic constitution 2. presence of symptoms or related history of any major disease, including but not limited to heart, liver, kidney diseases or other acute and chronic digestive tract diseases, respiratory diseases, bone and joint diseases, as well as blood, endocrine, nerve, mental and other systemic disease, or any other diseases or physiological conditions that could interfere with the results; 3. any surgical condition or condition that may significantly affect the metabolism and excretion of drug absorption and distribution, or that may pose a hazard to the subjects participating in the study; any surgical condition or condition that may significantly affect the absorption, distribution, metabolism, and excretion of the study drug, or any surgical condition or condition that may harm to the subjects participating in the study; 4. subjects who donated blood or lost 400 ml of blood within 3 months prior to screening; the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Keywords: hyperlipidemia
a clinical study to determine the safety and effectiveness of dentinal hypersensitivity treatment with two different toothbrushes

Conditions: Dentin Sensitivity

Summary: this study will determine the effects toothbrush type (power or manual) has on the safety and effectiveness of professional dentinal hypersensitivity treatment with a marketed oxalate-containing solution.


Eligibility criteria:
inclusion criteria: * be at least 18 years of age; * provide written informed consent prior to participation and be given a signed copy of the informed consent form; * complete a photography consent agreement pertaining to the collection and use of non-identifying intraoral photographs; * be in good general health as determined by the investigator/designee; and * have at least one tooth with a schiff sensitivity score of at least 1 in response to the cool air challenge. exclusion criteria: * self-reported pregnancy or nursing; * severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession; * active treatment of periodontitis; * any diseases or conditions that might interfere with the safe completion of the study; or * an inability to undergo any study procedures.

Keywords: sensitivity
effects of om-174 in adult patients with solid tumors

Conditions: Solid Tumors

Summary: methods patients received om-174 twice weekly for a total of 5, 10 or 15 injections of either 600, 800 or 1000 µg/m². pharmacokinetic analysis and cytokine dosages were performed. natural killer cells activity and toll-like receptors 4 polymorphism analysis were also performed.


Eligibility criteria:
inclusion criteria: * patient with a histologically proven solid tumor, refractory to conventional treatment or for which no such treatment existed. * at least one month since the last chemotherapy * life expectancy above 3 months * written informed consent * age above 18 exclusion criteria: * patient's refusal * infection * brain metastasis * autoimmune disease * regular use of steroids * patient included in another protocol * chemotherapy or radiotherapy less than 6 weeks ago * immunotherapy less than 8 weeks ago
safety of a single, intravitreal injection of human retinal progenitor cells (jcell) in retinitis pigmentosa

Conditions: Retinitis Pigmentosa (RP)

Summary: this study evaluates the safety and potential activity of a single dose of live human retinal progenitor cells (jcell) administered to adults with retinitis pigmentosa. four different dose levels of cells will be assessed in each of two groups of patients.

the primary purpose of this study is to test the safety and tolerability of the administration of a single dose of jcell to adults with retinitis pigmentosa. the goal of jcell therapy is to preserve vision by intervening in the disease at a time when host photoreceptors can be protected and potentially reactivated. human allogeneic retinal progenitor cells will be injected into adults with advanced rp to see if the procedure is safe, if the cells survive, and whether they have any impact on the visual status of the patients.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of rp confirmed by electroretinogram (erg) and willing to consent to mutation typing, if not already done * best corrected visual acuity (bcva) 20/63 or worse and no worse than hand motions (hm) * adequate organ function and negative infectious disease screen * female of childbearing potential must have negative pregnancy test and be willing to use medically accepted methods of contraception throughout the study exclusion criteria: * eye disease other than rp that impairs visual function * pseudo-rp, cancer-associated retinopathies * history of malignancy or other end-stage organ disease, or any chronic disease requiring continuous treatment with system steroids, anticoagulants or immunosuppressive agents * known allergy to penicillin or streptomycin
a phase 2 trial of aln-app in patients with cerebral amyloid angiopathy

Conditions: Cerebral Amyloid Angiopathy

Summary: the purpose of the study is to evaluate the effect of aln-app on measures of caa disease progression and to characterize the safety, tolerability, and pharmacodynamics (pd) of aln-app in adult patients with sporadic caa (scaa) and dutch-type caa (d-caa). the study will be conducted over 2 periods: a 24-month double-blind treatment period and an optional 18-month open-label extension (ole) period. the estimated duration of study participation, inclusive of screening, treatment, and additional safety follow-up, is up to 50 months.


Eligibility criteria:
inclusion criteria (sporadic caa patients): * is 50 years or older * has probable caa per the boston criteria version 2.0 inclusion criteria (dutch-type caa patients): * is 30 years or older * has known e693q amyloid precursor protein (app) gene mutation for dutch-type caa exclusion criteria: * moderate or severe stage alzheimer's disease (ad) or significant cognitive impairment (ci) * has a history of previous clinical intracerebral hemorrhage (ich) with onset less than 90 days prior to anticipated randomization in the study * has alanine aminotransferase (alt) or aspartate aminotransferase (ast) \>3×upper limit of normal (uln) at screening * has estimated glomerular filtration rate (egfr) \<30 ml/min/1.73m\^2 at screening * has recently received an investigational agent * has had treatment with amyloid-targeting antibody note: other protocol defined inclusion / exclusion criteria apply

Keywords: caa