Kornimate/medical-research-clean huggingface dataset:
bms-247550 in treating patients with stage iv melanoma

Conditions: Recurrent Melanoma; Stage IV Melanoma

Summary: phase ii trial to study the effectiveness of bms-247550 in treating patients who have stage iv melanoma. drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die

objectives: i. determine the efficacy of bms-247550 in patients with stage iv melanoma. ii. determine the toxicity of this drug in these patients. outline: this is a multicenter study. patients are stratified according to the number of prior chemotherapy regimens (0 vs 1-2, including dacarbazine or temozolomide). patients receive bms-247550 iv over 1 hour on days 1, 8, and 15. courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed stage iv melanoma * at least 1 measurable lesion * greater than 20 mm by conventional techniques * greater than 10 mm by spiral ct scan * known brain metastases allowed if all of the following criteria are met: * radiologically stable for at least 6 weeks after completion of whole brain radiotherapy * stable at time of study * no mass effect present radiologically * no concurrent steroids to control symptoms of brain metastases * performance status - ecog 0-2 * performance status - karnofsky 60-100% * at least 3 months * absolute neutrophil count at least 1,500/mm\^3 * platelet count at least 100,000/mm\^3 * bilirubin normal * ast/alt no greater than 2.5 times upper limit of normal (uln) * creatinine no greater than 1.5 times uln * no symptomatic congestive heart failure * no unstable angina pectoris * no cardiac arrhythmia * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no prior severe allergic reactions (grade iii or iv or grade ii not responsive to steroids) to taxanes or medications containing cremophor el * no pre-existing grade 2 or greater peripheral neuropathy * no hiv-positive patients receiving combination antiretroviral therapy * no other concurrent uncontrolled illness * no ongoing or active infection * no psychiatric illness that would preclude study * prior vaccine therapy allowed * prior immunotherapy (e.g., interleukin-2 or interferon) allowed * stratum i: * no prior chemotherapy * stratum ii: * no more than 2 prior chemotherapy regimens (must have included dacarbazine or temozolomide) * see disease characteristics * see disease characteristics * prior limb-perfusion therapy allowed (stratum ii) * no other concurrent investigational or commercial agents or therapies intended to treat malignancy * no concurrent hypericum perforatum
comparative study of gender identity disorder versus control

Conditions: Gender Dysphoria, Adult

Summary: gender dysphoria is manifested by an internal tension between biological sex and gender, that is, by a non-congruence, in the subjects who suffer from it, between their sex of birth and their social gender identity.

gender dysphoria is manifested by an internal tension between biological sex and gender, that is, by a non-congruence, in the subjects who suffer from it, between their sex of birth and their social gender identity. gender dysphoria is accompanied by the often overwhelming need for a hormonal or even hormone-surgical transition. gender dysphoria is very often characterized by fluctuating mood sadness, irritability, obsessionality. an improvement in the quality of life after medical treatment (hormone therapy) and gender reassignment surgery has been described in the literature. morphological similarities have been found between the brains of women and the brains of so-called transgender women, as well as between the brains of transgender men and men. these morphological data are only very fragmentary and have not been supported by neuro-functional data. self-awareness, which refers to the awareness that an individual has of his body, his image and his own identity, is partly underpinned, at the brain level, by the activation of the default mode network (dmn) at rest, in non-pathological conditions. the conflict between the internal perception of the own body and its objective representation could result in a change in brain connectivity within the dmn, due in particular to changes in the activation of the temporo parietal junction.

Eligibility criteria:
inclusion criteria: * patients with gender dysphoria * without psychotropic * without hormono-therapy * without sexual surgery assignation exclusion criteria: * any depression * any addiction
the ontario multi-regional hospital covid-19 registry (coreg)- recovery trajectory sub-study

Conditions: COVID-19 Pneumonia; Sars-CoV-2 Infection

Summary: radiological and lung function recovery following covid-19 infection.

the investigators propose to conduct pulmonary ldct imaging and physiological lung function assessments, and combine this with detailed multi-regional hospitalization clinical data collection on covid-19 cases (coreg registry); to inform long-term pulmonary and extra-pulmonary consequences and the recovery trajectory following covid-19 infection.

Eligibility criteria:
inclusion criteria: * patients discharged from hospital post covid-19 infection who have radiographic and clinical evidence of covid-19 pneumonia during hospitalization. * patients with evidence of unresolved radiographic changes or persistent hypoxemia. exclusion criteria: * failure to comply with study procedures.
safety, tolerability, pharmacokinetics and pharmacodynamics of pf-06649751 in parkinson's disease

Conditions: Parkinson's Disease

Summary: this study will be an open label, dose escalation study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of repeated daily quaque die (qd) doses given over 21 days (day 3 to day 23) to sequential cohorts of subjects with parkinson's disease. each cohort will have 2 study periods. for each cohort, subjects will enter period 1 and if they meet criteria, approximately 12 subjects will be enrolled into period 2 and dosed with pf 06649751. based on results observed in a previous study, cohorts 1 and 2 will not be conducted. cohorts 3 - 6 will test doses uptitrated to 5 mg, 15 mg and 25 mg qd. doses may be modified based on emerging safety, tolerability and pk data, but the maximum daily dose that will be given in any cohort will have pk predictions at steady state that are anticipated to be below toxicokinetic limits. an option for down titration to the previous dose level is available should the investigator consider that an ae is intolerable. following down titration, a single up titration to the next dose level may be attempted if the subject remains symptom free for at least 48 hrs. safety, tolerability and pk data of cohort 3 will be reviewed prior to initiating the dosing in cohorts 4 and 5. available safety, tolerability and pk data up to day 24 of at least 5 subjects from cohorts 4 will be reviewed prior to initiating the dosing in cohort 6.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of idiopathic parkinson's disease with at least 2 out of 3 cardinal characteristics (tremor, rigidity, bradykinesia) * mini-mental state examination (mmse) ≥ 25 * hoehn \& yahr stage i-iii inclusive * documented history of end of l-dopa wearing off * cohort 5 only: history of dyskinesia following l-dopa dosing and score of at least 2 on part iv, item 4.2 (functional impact of dyskinesia) of the mds-updrs exclusion criteria: * atypical/secondary parkinsonism * history of surgical intervention for parkinson's disease * dementia/cognitive impairment that can interfere with study assessments
safety and targeting of anti-hk2 antibody in mcrpc

Conditions: Castration-Resistant Prostatic Cancer; Metastatic Disease

Summary: this is an imaging trial, to develop h11b6 as a therapeutic radiopharmaceutical for men with mcrpc. this imaging study will be conducted to confirm the safety and estimate the mass amount of antibody h11b6, and confirm in vivo tumor targeting of the antibody, using indium-111 (111in) radiolabeled h11b6 in subjects with advanced prostate cancer. this study will also provide the dosimetric information crucial for phase 1 therapy.

it is the intent to develop h11b6 as a therapeutic radiopharmaceutical for men with mcrpc. this phase 0 study will be conducted to confirm the safety, estimate the mass amount, and confirm in vivo tumor targeting of the antibody. this study will use indium-111 (111in) radiolabeled h11b6 in subjects with mcrpc to image known sites of disease and identify a favorable mass amount of antibody for satisfactory tumor targeting with minimal/no accumulation off-target. in cohort 1, in-111 labeled h11b6 will remain fixed at 2 mg, and additional h11b6 will be added in 2 sub-cohorts (8 mg and 18 mg respectively); up to 6 patients may be entered into a sub-cohort. additional patients (up to 6) will be studied once the most favorable mass and imaging time point have been established, to establish targeting of antibody to known disease. this study will provide the dosimetric information crucial for phase 1 therapy.

Eligibility criteria:
inclusion criteria: * subjects with mcrpc will be eligible if they meet the following criteria: * eastern cooperative oncology group (ecog) ≤ 1 * histologically or cytologically confirmed adenocarcinoma of the prostate * castrate levels of testosterone (\<50 ng/dl \[1.74 nmol/l\]) * metastatic disease documented by imaging * documented progressive mcrpc with androgen involvement as defined by - prostate cancer working group 3 * acceptable laboratory parameters * at least 28 days since administration of any therapeutic radioactive isotope * able to tolerate the conditions required to perform imaging studies (e.g., lying flat for at least 1 hour). exclusion criteria: * known hypersensitivity to proteins, or other allergic diathesis that, in the opinion of the investigator, makes an immune response to humanized antibody likely * radiotherapy or immunotherapy within 30 days, or single fraction of palliative radiotherapy within 14 days of administration of study agent * any condition that, in the opinion of the investigator, would impair the subject's ability to comply with study procedures and required study visits * active, symptomatic, or untreated brain metastases.

Keywords: radiolabeled antibody imaging
effectiveness of covid-19 vaccine for prevention of covid-19 in the dominican republic

Conditions: COVID-19

Summary: this study is a multisite ,grouped test-negative case-control , phase ⅳ clinical trial of an inactivated sars-cov-2 vaccine (coronavac) manufactured by sinovac research and development co., ltd.the purpose of this study is to estimate the protective effectiveness of complete vaccination (measured ≥14 days after the second dose) of coronavac against symptomatic sars-cov-2 infections ,covid-19 hospitalizations and severe cases.

this study is a multisite,grouped test-negative case-control , phase ⅳ clinical trial in population aged 18 years and older. the experimental vaccine will be manufactured by sinovac research and development co.,ltd.the study is planned to be carried out in ten (10) selected hospitals and their catchment communities in five provinces of the dominican republic (dr): national district, la altagracia, puerto plata, santiago, and santo domingo from july 1, 2021 to april 30, 2022 . a total of 1400 subjects will be enrolled with 700 estimated clinic cases who are diagnosed as sars-cov-2 infection by real-time polymerase chain reaction (rt-pcr); and 700 estimated clinic controls who have a negative rt-pcr test.and subjects will receive two doses of vaccine for primary immunization .

Eligibility criteria:
inclusion criteria: * aged ≥18 years; * permanent residents of study provinces; * able and willing to provide informed consent to participate in the study; * able and willing to provide nasopharyngeal swab and venous blood sample; * able and willing to complete a questionnaire survey for collecting information on histories of covid-19 vaccination and disease; * considered as suspected cases of sars-cov-2 infections by the physicians in the study clinics according to dr national protocol. exclusion criteria: -
a clinical study investigating the comparability of somatrogon in two different drug product presentations

Conditions: Healthy Male Volunteers

Summary: this is a phase 1, single-center, open-label randomized, 2×2 crossover (ref test \| test ref) study with a washout of two weeks to establish bioequivalence between single dose of somatrogon in a pen to somatrogon in vial administered sc in healthy male volunteers.

the subjects will undergo a screening period (day -28 to -1), and when eligible for study participation will be randomized to receive one sc injection of one of two somatrogon drug product presentations on day 0, either the pen or vial presentation. a series of blood draws and study procedures will be carried out over the course of the next 10 days to evaluate the subjects. following a two week washout period, the subjects will be brought back to the clinic to receive the other somatrogon drug product presentation, and once again followed for the next 14 days to study completion.

Eligibility criteria:
inclusion criteria: * healthy male volunteers aged 18-55 (inclusive) years * body mass index (bmi) 19 to 32 kg/m2 (inclusive) and weighing at least 55 kg * non-smoking (by declaration) for a period of at least six months prior to screening visit exclusion criteria: -
effect of andiroba on control of post-whitening tooth sensitivity

Conditions: Tooth Bleaching; Pain; Dentin Desensitizing Agents

Summary: this randomized clinical trial will evaluate the effect of an experimental gel containing andiroba oil (carapa guianensis) in reducing postoperative tooth sensitivity caused by bleaching with 35% hydrogen peroxide. volunteers in this study will be randomized into 3 different groups - pg (placebo gel), kf2g (potassium nitrate gel) and ag (andiroba gel). groups kf2g and ag will receive treatment with potassium nitrate desensitizing gel and the experimental andiroba gel, respectively. this will be applied to the buccal surfaces of the central incisors, lateral incisors, canines and upper and lower premolars, with a rubber cup in an active manner, for 10 minutes. group gp will receive the application of a placebo gel (without active ingredient), under the same conditions described for the other groups. subsequently, all groups will undergo in-office bleaching treatment with 35% hydrogen peroxide. post-bleaching sensitivity will be collected using a form consisting of the visual analogue scale (vas). color measurement will be performed with a spectrophotometer at two times: baseline (t0) and one week after the 3rd bleaching session (t1).

all groups will undergo in-office whitening treatment, carried out in 3 sessions with a 7-day interval, according to the steps described below: prophylaxis; application of gingival barrier; application of desensitizing agent or placebo, according to the established groups; handling of the whitening material following the manufacturer's instructions: application of whiteness hp 35% whitening gel for 15 minutes each, totaling 45 minutes; final removal of the whitening gel and gingival barrier, followed by rinsing with water. the application of the desensitizing agent or its placebo will follow this sequence: relative isolation with cotton rolls; active application of the product on the buccal surfaces of all teeth using a rubber cup for 10 minutes; rinsing with water.

Eligibility criteria:
inclusion criteria: * good oral hygiene * absence of active caries lesions * never having undergone previous whitening therapy * not present dental hypersensitivity * don\&#39;t be a smoker * not be pregnant * present at least 28 teeth in the oral cavity. exclusion criteria: * volunteers who were under orthodontic treatment, * presence of periodontal disease * dental cracks or fractures * restorations and prostheses on anterior teeth * extensive molar restorations * gastroesophageal disorders * severe internal dental darkening * presence of dentinal exposure in anterior and / or posterior teeth.
care4today v2.0 application for improving adherence to hiv medications

Conditions: HIV; AIDS

Summary: although poor antiretroviral (art) adherence in hiv does not mean a complete lack of therapeutic results, the benefit of art increases as adherence improves. consequences of suboptimal art adherence are viral rebound, development of drug-resistant hiv strains, and more rapid progression to aids. moreover, hiv-infected persons tend to have numerous co-occurring conditions and therefore take many medications making adherence to multiple drug regimens more difficult. a mobile application capable of improving medication adherence among hiv-infected persons would be highly useful. the investigators propose an intervention study designed to address these potential mechanisms of nonadherence by utilizing the care4today v2.0 smartphone application (app). the current study is a small pilot randomized controlled trial (rct) comparing the smart phone application titled "care4today v2.0" versus standard of care to improve medication adherence to art over a 4-week period with 60 hiv-infected participants. the pilot rct consists of 60 hiv-infected persons who are at risk for art medication nonadherence. using random assignment, 30 hiv-infected participants will be assigned to medication adherence improvement via "care4today" app as compared to 30 hiv-infected participants assigned standard of care. the investigators will assess the effectiveness and acceptability of the app in improving objectively measured art adherence (i.e., via medication event monitoring system caps) over a 4-week period via a pilot rct with 30 hiv-infected persons assigned to the care4today intervention and 30 hiv-infected persons assigned to standard of care.


Eligibility criteria:
inclusion criteria: * ability to provide informed consent * 18 years or older at the time of enrollment * hiv-infected * taking at least one medication to treat hiv illness * indication of medication nonadherence, or having a condition (e.g., active substance use, depression) that puts the individual at risk for medication non adherence * willingness to use electronic monitoring caps to track art medication * willingness to respond to application alert messages exclusion criteria: * axis i psychiatric diagnosis of psychotic disorder or mood disorder with psychotic features * presence of a neurological condition (beyond hiv infection) known to impact cognitive functioning (e.g., huntington's disease, stroke) * unwillingness or inability to use electronic medication monitoring technology * unwillingness or inability to use daily alert messages

Keywords: interventions technology adherence arv
transverse myelitis related to sars-cov-2 vaccines

Conditions: Vaccine Adverse Reaction

Summary: few patients receiving sars-cov-2 vaccines may experience rare but serious adverse events such as transverse myelitis (tm). today, data about tm are scarce. the objective was to investigate reports of tm adverse events related to sars-cov-2 vaccines labelled by fda and ema, including chadox1ncov-19 (oxford-astrazeneca), bnt162b2 (pfizer/biontech), mrna-1273 (moderna) and ad26.cov2.s (janssen/johnson \& johnson) and using the world health organization's (who) pharmacovigilance database: vigibase.

here, investigators use the world health organization's (who) database of individual safety case reports, to identify cases of tm related to sars-cov-2 vaccines.

Eligibility criteria:
inclusion criteria: - case reported in the world health organization (who) database (vigibase) of individual safety case reports at the time of the extraction, exclusion criteria: * chronology not compatible between the sars-cov-2 vaccine adminisration and onset of tm. * vaccines non-labelled by fda/ema (data cutoff december 10, 2021)
tissue-engineered skin graft repair of autologous scar dermal scaffolds

Conditions: Scar

Summary: hypertrophic scar is an inevitable outcome of wound repair. it affects the appearance and some scar contracture often leads to joint dysfunction.patients have low quality of life, long treatment cycle, heavy social burden and high medical costs.skin grafting is currently the gold standard for scar repair.however, there are often insufficient skin sources, easy to scar recurrence, lack of skin accessory organs.the application of composite skin graft can reduce the recurrence rate of scar healing and relieve the deficiency of skin source.however, its survival rate is not high, and acellular allogeneic dermal scaffolds are expensive, heavy medical burden.therefore, how to effectively repair the wound surface after surgical excision of scar is the main problem to be solved urgently. dermal loss is the main cause of unsatisfactory scar repair and recurrence.the previous clinical study of the research group found that the application of autologous epidermal basal cells and autologous skin graft obtained in real time during the operation could effectively improve the survival rate of skin graft in the treatment of wound surface (brit j surg, 2015).furthermore, it is suggested that the application of autologous scar dermal scaffolds can achieve the control of skin damage in the skin harvesting area and the orthotopic transplantation of autologous scar tissue dermal scaffolds, which can effectively reduce the economic burden of patients.therefore, the researchers wondered whether the construction of tissue-engineered skin orthotopic transplantation with autologous epidermal basal cells and autologous scar dermal scaffold combined with autologous scar dermal scaffolds to repair the wound after scar resection could improve the survival rate of skin graft and reduce scar recurrence.to this end, we plan to carry out multi-center, prospective, randomized, controlled clinical trials, aiming at proposing more effective surgical treatment guidelines for the repair of hypertrophic scar, improving the survival rate of composite skin graft, and solving the current clinical problems of hypertrophic scar repair.


Eligibility criteria:
inclusion criteria: the patient is diagnosed as hypertrophic scar and needs surgical repair; the scar size was 10cm2 to 200cm2, and the site was not limited; patients with stable vital signs and tolerable operation indicated by routine examination; patients in good mental state, can follow the doctor's advice, regular return; those whom the researchers considered unsuitable for inclusion; patients have participated in this study at any time in the past; those whom the researchers considered unsuitable for inclusion; patients have participated in this study at any time in the past. exclusion criteria: those who did not meet the inclusion criteria were found after the selected subjects; the follow-up time after inclusion was less than 2 times, and the objective efficacy could not be evaluated (but the adverse reactions could be evaluated); subjects who violate protocol requirements.