Kornimate/medical-research-clean huggingface dataset:
exploratory study of ifx-1 in patients with pyoderma gangrenosum

Conditions: Pyoderma Gangrenosum

Summary: the purpose of this study is to determine whether vilobelimab (development name: ifx-1) is safe and effective in the treatment of pyoderma gangrenosum.

neutrophilic dermatoses are a spectrum of inflammatory disorders characterized by skin lesions resulting from a neutrophil-rich inflammatory infiltrate in the absence of infection. pyoderma gangrenosum is associated with a neutrophilic leukocytosis, which is likely to be triggered by c5a. this study is set up based on the hypothesis that vilobelimab might be able to block c5a induced pro-inflammatory effects such as neutrophil activation and cytokine generation, potentially contributing to the local skin inflammation and tissue damage.

Eligibility criteria:
inclusion criteria: * diagnosis of an ulcerative form of pyoderma gangrenosum confirmed by the investigator in addition, the subject must fulfill at least 3 of the following 6 criteria at screening: history of * pathergy (ulcer occurring at the sites of trauma) * personal history of inflammatory bowel disease or inflammatory arthritis * history of papule, pustule or vesicle that rapidly ulcerated clinical examination (or photographic evidence) of * peripheral erythema, undermining border, and tenderness at site of ulceration * multiple ulcerations (at least 1 occurring on the lower leg) * cribriform or "wrinkled paper" scar(s) at sites of healed ulcers subject has a minimum of 1 evaluable ulcer (≥2 cm2) on the lower extremity at screening exclusion criteria: * pyoderma gangrenosum target ulcer for more than 3 years before screening * surgical wound debridement within the previous 2 weeks before screening * use of intravenous antibacterials, antivirals, anti-fungals, or anti-parasitic agents within 30 days before screening * any drug treatment for pyoderma gangrenosum including corticosteroids (\>10 mg), intralesional steroids, cyclosporine a, biologicals and immunosuppressives (with the exception of antibiotics for wound superinfection) used within a time of 5 half-lives of the drug before screening
predictive score of pneumothorax secondary to ct-guided transthoracic lung biopsy made from a large retrospective cohort and validated on a prospective cohort

Conditions: Pneumothorax

Summary: transthoracic lung biopsy (tlb) provides a histological diagnosis of nodule or lung mass. pneumothorax is the main complication of tlb with an average of 20%. many risk factors, whether clinical, computed tomography or related to tlb, are described in the literature. the british thoracic society recommends monitoring for 2 hours after the procedure with a possible discharge if the chest x-ray is normal. there is no french or european recommendation for monitoring the occurrence of pneumothorax after tlb. in the university center of besançon, france, a minimum supervision of 4 hours is recommended and approximately one in two patients is hospitalized until the following day to reach this minimum time of 4 hours. the objective of the spot study is to perform a predictive score of pneumothorax from a retrospective cohort of patients for whom a transthoracic lung biopsy was performed and to validate this score on a prospective cohort. the expected goal is to select patients who can benefit from outpatient care by shortening the post-procedure surveillance period and to monitor more long-term only high-risk patients.


Eligibility criteria:
inclusion criteria: * patients having needle lung biopsy ct-guided for diagnostic purposes. exclusion criteria: * nodule or mass in contact with the pleura for which the aerated pulmonary parenchyma is not crossed by the puncture needle. * several pulmonary sites biopsied. * existence of a pneumothorax before procedure * per-procedural appearance of alveolar or interstitial pneumonitis at the level of the biopsy area. * cavitary aspect of nodule or mass * absence of chest x-ray control * poorness quality of chest x-ray control

Keywords: lung lesions pneumothorax ct-guided transthoracic biopsy risk score
preservation of swallowing in respected oral cavity squamous cell carcinoma: examining radiation volume effects (preserve): a randomized trial

Conditions: Head and Neck Cancer

Summary: the goal of this randomized treatment study is to formally compare quality of life in patients with at least one pn0 hemi-neck after resection of a squamous cell carcinoma of the oral cavity treated with a primary radiation therapy versus a secondary targeted radiation therapy approach, to provide a high level of evidence to guide the selection of treatment options.

the goal of this randomized treatment study is to formally compare quality of life in patients with at least one pn0 hemi-neck after resection of a squamous cell carcinoma of the oral cavity treated with a primary radiation therapy versus a secondary targeted radiation therapy approach, to provide a high level of evidence to guide the selection of treatment options. the study will require a sample size of 90 patients randomized in a 2:3 between the two arms. arm 1 (standard radiation therapy to tumor location and surrounding area) and arm 2 (targeted radiation therapy to tumor location). patients will be followed for a total of 5 years.

Eligibility criteria:
inclusion criteria: * willing to provide informed consent * ecog performance status 0-2 * histologically confirmed, resected oral cavity squamous cell carcinoma with at least ipsilateral selective neck disection * patient has pathological features that are indications for port: positive or close (≤ 3 mm) margin, presence of lvi or pnu, pt3 or pt4 disease, positive lymph nodes, and port is recommended by treating physician * pathologically lympth node negative in at least one dissected hemi-neck with at least 10 nodes recovered in each pn0 hemi-neck exclusion criteria: * serious medical comorbidities or other contraindications to radiotherapy * prior history of head and neck cancer within 5 years * any other active invasive malignancy, except non-melanotic skin cancers * prior head and neck radiation at any time * prior oncologic head and neck surgery in the oral cavity or neck * metastatic disease * locoregional disease recurrence identified following surgical resection but prior to the start of radiotherapy * inability to attend full course of radio therapy or follow-up visits * unable or unwilling to complete qol questionnaires * pregnant or lactating women

Keywords: radiation therapy oral cavity squamous cell carcinoma randomized trial
video game exercise effectiveness of a domiciliary pulmonary rehabilitation program in cystic fibrosis patients

Conditions: Cystic Fibrosis

Summary: the aim of this study is to evaluate the efficacy of a long-term domiciliary exercise program using the wii video game platform as a training modality in cystic fibrosis (cf) patients. investigators hypothesize that an exercise program performed by active videogames (avg) will produce an improvement in exercise tolerance and muscular strength to be maintained over time in young cf patients.

this is a randomized and longitudinal trial. participants will be randomize in 2 groups: control group (cg) and experimental group (eg), by the ©grapfpad software, inc. the cg will carry out their routine patient management, and the eg will perform also a domiciliary pulmonary rehabilitation program of 30-60 min exercise, 5 days/week during 6 weeks using a nintendo wiitm platform with the game ea sports active 2. before and after we will measure: 1. exercise tolerance using the six minutes walk test (6mwt) and the modified shuttle walk test (mswt); 2. muscular strength using horizontal jump test (hjt), medicine ball throw (mbt) and handgrip strength (right hand (hgr); left hand (hgl)); and 3. hrqol using the 3 versions of the cystic fibrosis questionnaire-revised (cfq-r 6-11, cfq-r 14+, cfq-r parents).

Eligibility criteria:
inclusion criteria: * patients with diagnosis of cf, clinically stable without exacerbations of the disease in the previous 6 weeks to the inclusion date. exclusion criteria: * to present clinical evidence of cardiovascular, neuromuscular or osteo-articular comorbidities that limit the participation in exercise programs. * lung transplant candidates and those patients that followed any kind of rehabilitation program 12 months before the study.

Keywords: cystic fibrosis exercise capacity interactive gaming console pulmonary rehabilitation
ameliorative potential of relaxing back massage on puerperial women's hormones and infant weight

Conditions: Does Postpartum Massage Affect Leptin, Prolactin and Growth Hormone

Summary: effect of massage on hormone levels in puerperal women

postpartum back massage can effectively increase prolactin, growth hormone levels, which in turn can make the baby's growth more healthy and decrease leptin levels, which can protect the child from future obesity and so, clinicians should advise postpartum women to have massage after delivery.

Eligibility criteria:
inclusion criteria: * puerperal women within 4 hours of normal delivery and they are primiparous exclusion criteria: * nulliparous more than 30 years or less than 25 years chronic diseases caesarean delivery
tolerance & responsiveness improvement for metformin (trim)

Conditions: Type2 Diabetes Mellitus

Summary: the overall goal is to explore the hypothesis that prebiotic fiber psyllium will ameliorate diarrhea in african american men (aam) with type2 diabetes mellitus (t2d).


Eligibility criteria:
inclusion criteria 1. male (m) 2. african american (aa) race 3. age 20-70 years 4. bmi 28-59 kg/m2 5. t2d 6. a1c 6.5 - 8.9% 7. egfr =/\> 30 8. drug-naïve or use glipizide or newly started on metformin (within 2 weeks). exclusion criteria 1. chronic kidney disease stage 3b, 4 and 5 (egfr \< 30) 2. insulin use 3. oral steroids use (inhalers and creams are allowed) 4. antibiotic use within the last month 5. artificial heart valves 6. hospitalization for chronic condition within 6 months prior to the study 7. history, manifestations or medications of significant metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, urological, neurological, psychiatric/ psychological disorders, or social circumstances which in the opinion of the investigator would be expected to interfere with the study or increase risk to the subject. 8. use of other antidiabetic drugs (except glipizide and metformin). 9. acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. additional exclusion criteria for subjects who previously used metformin: 1. previous severe allergic reaction to metformin hydrochloride, such as angioedema. 2. previous metformin intolerance causing significant diarrhea or gi-upset. would not exclude participants who had history of mild diarrhea with metformin use. 3. previous side effects that the subject feels were related to metformin and the subject is not interested to re-try metformin.
effectiveness of alcohol swabs for preventing infections during vaccination

Conditions: Skin Infection

Summary: alcohol is used to disinfect the skin prior to injections in order to prevent infections caused by bacteria on the skin being injected within tissue. at present, however, clinical trials do not demonstrate a clinical impact of using or not using alcohol swabs on infections and infection symptoms calling into question the practice of using it prior to all injections. these studies are methodologically flawed, and do not specifically examine vaccine injections. the present study is being undertaken to provide some preliminary data for the risk of infection and infection symptoms when alcohol swabs are not used to perform vaccine injections.

alcohol is used to disinfect the skin prior to injections in order to prevent infections caused by bacteria on the skin being injected within tissue. alcohol has been shown to be a good disinfectant, reducing the number of bacteria on skin by 47-91%. however, in previous clinical trials, there has been no clinical impact of using or not using alcohol swabs on infections and infection symptoms calling into question the practice of using it prior to all injections. these studies, however, are generally of low scientific rigor (e.g., not randomized, not blinded, did not use standard case definitions of the adverse reactions being measured). moreover, it is important to note that none of them specifically evaluated vaccine injections, the most common type of injection worldwide. at present, based on the available evidence base, the world health organization (who) and the centre for disease control (cdc) do not recommend the use of alcohol swabs before vaccine injections. as a result, immunizers in many countries around the world currently do not cleanse the skin with alcohol prior to vaccination. despite these recommendations, clinicians in our community and across canada commonly use alcohol swabs prior to all vaccine injections. in this application, investigators will undertake a pilot randomized study to evaluate the incidence of infection symptoms and infections in children undergoing vaccination with and without skin cleansing with alcohol swabs.

Eligibility criteria:
inclusion criteria: * healthy pediatric patients undergoing routine vaccinations exclusion criteria: * no contra-indications to vaccination or alcohol swab, * ability to understand english and consent to the study

Keywords: skin infection vaccination children alcohol swab skin preparation
a study to investigate the immunogenicity, reactogenicity, and safety of mrna-1083 (influenza and covid-19) vaccine in adults ≥18 to <65 years of age

Conditions: Influenza; SARS-CoV-2

Summary: the purpose of this study is to evaluate the immunogenicity, reactogenicity, and safety, of mrna-1083 multicomponent influenza and covid-19 vaccine in adults ≥18 to \<65 years of age.


Eligibility criteria:
inclusion criteria: * medically stable. * participants who could become pregnant: negative pregnancy test and contraception for at least 28 days prior to day 1 and for at least 90 days after the study intervention administration. * have received ≥2 coronavirus disease 2019 (covid-19) vaccines, with the last covid-19 vaccine administered \>150 days prior to day 1. exclusion criteria: * history of a diagnosis or condition that is clinically unstable or may affect participant safety, assessment of study endpoints, assessment of immune response, or adherence to study procedures. * tested positive for influenza by local health authority-approved testing methods within 150 days prior to day 1. * history of severe acute respiratory syndrome coronavirus 2 (sars-cov-2) infection within 150 days prior to day 1. * received systemic immunosuppressive treatment, including long-acting biological therapies that affect immune responses (eg, infliximab), within 180 days prior to day 1 or plans to do so during the study. * received or plans to receive any vaccine authorized or approved by a local health agency within 28 days prior to day 1 or plans to do so within 28 days post study injection. * received a licensed seasonal influenza vaccine within 150 days prior to day 1. * received a licensed/authorized covid-19 vaccine within 150 days prior to day 1. * received any investigational influenza vaccine, investigational covid-19 vaccine, or investigational combination vaccine for influenza and covid-19 within 12 months prior to day 1. * participated in a clinical study with investigational treatment within 90 days prior to day 1 (baseline). other protocol-defined inclusion/exclusion criteria may apply.

Keywords: influenza sars-cov-2 mrna-1083 covid-19 messenger rna moderna
the effect of trazodone on the severity of obstructive sleep apnea in insomnic stroke patients with depression

Conditions: Sleep Apnea Syndromes; Cerebral Infarction

Summary: the investigators hypothesize that trazodone does not worse nocturnal oxygen saturation in insomnic ischemic stroke patients with obstructive sleep apnea (osa) and depression and has beneficial effect in selected stroke patients with low arousal threshold phenotype osa.


Eligibility criteria:
inclusion criteria: * insomnic ischemic stroke patients with osa and depression. exclusion criteria: * unclear consciousness, unstable vital sign or neurologic sign, unstable medical conditions such as delirium, active infection, evidence of overt congestive cardiac failure, liver dysfunction with ascites, thyroid disease, end-stage-renal-disease receiving dialysis. * overnight mean oxygen saturation (sao2) nadir is ≤ 70% at baseline * take monoamine oxidase inhibitors (maoi), any medication that may affect breathing, sleep, or muscle activity * any known allergy to trazodone * sleep disorder other than osa (e.g., periodic leg movement syndrome, restless legs syndrome, central sleep apnea/cheyne-stokes respiration).
study to evaluate the effect of kb001-a on time-to-need for antibiotic treatment

Conditions: Cystic Fibrosis

Summary: the purpose of this study is to confirm and extend the phase 1-2 kb001 findings of an airway anti-inflammatory effect in cf individuals with chronic pseudomonas aeruginosa (pa) airway infection. it is hypothesized that steady-state levels of kb001-a in cf subjects with airway pa infection will be safe and well-tolerated, and will increase the time-to-need for antibiotic treatment (iv, inhaled, or oral) for worsening of respiratory tract signs and symptoms compared with placebo.


Eligibility criteria:
inclusion criteria: * individuals with cf who are older than 50 years of age may participate if treated with 2 or more courses of antibiotics (iv and/or oral) for respiratory sign and symptoms (cf exacerbation) in the 12 months before the screening visit * confirmed diagnosis of cf * at least 2 respiratory tract cultures in the previous 12 months, with pa present. the most recent positive pa culture must be within 12 weeks before the screening visit (or obtain a positive culture at screening) * fev1 % levels within acceptable ranges (per the study protocol) * received inhaled abx for equivalent of 8 weeks or greater in the 26 weeks before the day 0 visit exclusion criteria: * treatment with antibiotics for acute illness within the 4 weeks before the day 0 visit * use of systemic corticosteroids within the 4 weeks before the day 0 visit * any change in regimen of cf maintenance therapies within the 4 weeks before the day 0 visit * history of sputum cultures positive for b. cepacia complex in the 2 years before the screening visit * history of organ transplantation * current smoker (tobacco, marijuana, or any other material). use of smokeless inhalers/vaporizers for these materials is also prohibited * history of drug addiction or alcohol abuse in the 12 months before the screening visit * history of hepatic disease (clinical cirrhosis or portal hypertension), renal dysfunction * breast-feeding or pregnancy as evidenced by a positive blood pregnancy test * receiving any investigational drug in the 16 weeks (or 5 half lives) before the day 0 visit, whichever is longer

Keywords: cystic fibrosis pseudomonas aeruginosa (pa) cf
prospective patient reported outcomes (pro) registry in patients with advanced renal cell carcinoma

Conditions: Renal Cell Carcinoma

Summary: evaluation of patient reported outcomes ( pro) regarding typical ailments in the real life renal cell carcinoma population

the pro kidney project will recruit a representative cohort of patients with advanced renal cell carcinoma (rcc) treated with systemic antiproliferative therapies such as tkis, mtor inhibitors, cytokines, antivegf or immune therapy. the aim of this study is to collect data on the effectiveness and patients´quality of life on preference in the real life setting. patient reported outcomes ( pro) are assessed by a questionnaire consisting functional assessment of cancer therapy ( fact) kidney syndrome index 19 (fksi 19) completed by four questions assessing ailments about changes in skin of hands/feet, taste, color of hair and mouth scores. 13 questions about fatigue assessed with the functional assessment of chronic iilness disease.

Eligibility criteria:
inclusion criteria: * histologically confirmed renal cell carcinoma * start of the first line systemic treatment * ability to read and understand german * written informed consent exclusion criteria: * none

Keywords: patient reported outcomes
opsumit users registry

Conditions: Pulmonary Arterial Hypertension

Summary: prospective observational drug registry developed to characterize the safety profile (including primarily potential serious hepatic risks) and to describe clinical characteristics and outcomes of patients newly treated with opsumit in the post-marketing setting.


Eligibility criteria:
inclusion criteria: patients newly treated with opsumit defined as a new user of therapy, initiated ≤ 30 days prior to enrollment visit. signed icf exclusion criteria: previous user of opsumit defined as patient who initiated therapy \>30 days prior to enrollment. patients enrolled in any ongoing clinical trials

Keywords: pah pulmonary arterial hypertension
the study of internet-delivered, transdiagnostic treatments for anxiety and depression

Conditions: Anxiety Disorders; Depression

Summary: anxiety and depression are common psychiatric disorders, resulting in suffering and impaired functioning for the individual. today, most psychological treatments are disorder specific, even tough comorbidity between depression and anxiety and different anxiety disorders is rule rather than exception. transdiagnostic treatments target the common features between depression and anxiety disorders and has shown to be as effective as disorder specific treatments in reducing symptoms of the disorders. unified protocol and affect phobia treatment are two types of transdiagnostic treatments that, to our knowledge, never been compared in research before. internet-administered treatment presents a promising way to increase availability of psychotherapeutic interventions such as transdiagnostic treatments. however, questions regarding the optimal treatment length and level of support remain unanswered. the aim of this study is to examine two internet-administered transdiagnostic treatments and their effect on anxiety and depression, and to investigate the impact of treatment length and access to a moderated forum. the study will investigate three factors: type of transdiagnostic treatment, length of treatment and whether patients have access to a moderated forum or not. 2400 participants with anxiety and/or depression will be randomly assigned to one of 12 subgroups and subsequently offered treatment based on differing combinations of the previously mentioned factors (200 participants/arm). the treatment conditions are internet-administered cognitive, behavioral treatment (cbt) unified protocol and the psychodynamic affect phobia treatment as well as a waitlist control group. participants will also be randomized to either 8 or 16 weeks of treatment and access to a moderated forum or not. primary outcome measures will be the patient health questionnaire, the generalized anxiety disorder 7-item scale and the brief quality of life scale. negative effects of treatment will also be assessed. in addition to pre- and post-treatment measurements, the study includes one mid-treatment and three follow-up assessments (6, 12 and 24 months).


Eligibility criteria:
inclusion criteria: * be able to read and write swedish, * access to a mobile phone/computer, * 18 years or older, * gad-7 ≥ 5 and/or * phq-9 ≥ 10. exclusion criteria: * partaking in other psychological treatment, * has started or adjusted treatment with psychopharmacological drugs for anxiety, worry or depression within the nearest month, * severe depression (phq-9 ≥ 20) or suicidal (phq-9, item 9\>2).