Kornimate/medical-research-clean huggingface dataset:
a 24 hour occlusive single patch test to assess acute tolerance of pre lubricated condom on a panel of healthy adult subjects

Conditions: Healthy

Summary: this is a 24 hour patch test to determine the acute tolerance of 3 variants of condom on a panel of healthy adult subjects. the patches will be affixed to the back and remain under occlusion for 24 hours. they will then be assessed at 30 minutes and 24 hours post patch removal.

three test products (plus positive and negative control) will be applied to the back using occlusive tape and will remain on the skin for 24 hours. the patches will be removed after 24 hours and assessed as 30 minutes post patch removal and again at 24 hours post patch removal. each test site will be scored for erythema and oedema by a dermatologist. the primary endpoint for this clinical investigation is the irritation of the test products according to the cutaneous irritancy index value. the test products success criteria is to be graded as 'non-irritant' and this should be confirmed by the study dermatologist.

Eligibility criteria:
inclusion criteria: * subjects who are able to give written informed consent and from whom written informed consent has been obtained * generally healthy male or female subjects between the ages of 18 and 70 years inclusive. * subjects assessed by the dermatologist as having normal/healthy skin. * subjects with skin phototype i to iv skin. * subjects who have been exposed to natural rubber latex through condom use with no allergic reaction being raised * subjects, who are able to understand the study, co-operate with the study procedures (including no swimming during the study period) and are able to attend all study assessments. exclusion criteria: * female subjects who are pregnant, lactating or have given birth within the previous 3 months or are planning to be pregnant during the study. * female subjects of childbearing potential who, for the duration of the study, are either unwilling or unable to take adequate contraceptive precautions or are unwilling to be sexually abstinent. * subjects with previous experience of intolerance or allergic reactions to any components of the test products including latex and lubricants. * subjects with either form of diabetes. * subjects with an active skin disorder or a significant history of skin disorders (e.g. psoriasis, eczema, vitiligo, pityriasis versicolor, acne) which in the opinion of the principle investigator or dermatologist may affect the test results * subjects whose skin has been excessively exposed to the sun or to uv rays during the previous month in the opinion of the investigator. * subjects who are suffering from chronic asthma, a malfunction of the lymphatic system or an autoimmune deficiency diseases (e.g. lupus, thyroiditis). * subjects with very easily irritated/sensitive skin in the opinion of the investigator.

Keywords: safety study new product normal healthy skin.
prophylaxis of periprosthetic joint infections with calcium sulfate beads in patients with non-modifiable risk factors.

Conditions: Infection

Summary: to demonstrate the prophylactic effect of calcium sulfate beads loaded with antibiotic in patients with non-modifiable risk factors that will undergo a hip or knee joint replacement, comparing with a control group. to know the economic cost generated in antibiotic prophylaxis with calcium sulfate beads in patients undergoing hip or knee joint replacement with non-modifiable risk factors.

since joint replacement procedures have been successful in recent decades, every year the number of implanted prostheses is increasing, however, at the same time, orthopaedic surgeons also find complications inherent to this surgery, where peri-prosthetic infection results to be the most devastating. in order to find a solution to this terrible complication, prophylactic and therapeutic measures have been implemented, emerging techniques where the application of local antibiotics in the surgical site has turned out to be a promising concept. it has been shown that the non-modifiable risk factors of patients undergoing joint replacement surgery increase the risk of infection rate. therefore, the identification of risk factors, decolonization and the prophylactic administration of antibiotics allow an effective reduction of periprosthetic infection. in order to reduce and, as far as posible, avoid periprosthetic infections in participants undergo knee or hip joint replacement with non-modifiable risk factors, the prophylactic use of calcium sulphate loaded with antibiotic for local application is proposed.

Eligibility criteria:
inclusion criteria: * patients with fracture or osteoarthrosis of the hip or knee that require treatment by joint replacement. * patients who have any of the non-modifiable risk factors prior to surgery or during transoperative period. * patients entitled to the issemym (instituto de seguridad social del estado de mexico y municipios) exclusion criteria: * patients that lose their validity of institutional rights and do not follow up * patients who die during the study due to other causes not related to the orthopedic procedure. * patients who do not have any of the risk factors for periprosthetic infection * patients allergic to vancomycin or ceftriaxone.

Keywords: periprosthetic joint infection prophylaxis joint replacement calcium sulfate beads
aripiprazole augmentation of antidepressants in ptsd

Conditions: PTSD

Summary: the proposed investigation will determine the therapeutic potential of aripiprazole augmentation to a stable antidepressant regimen for reducing posttraumatic stress disorder (ptsd) symptoms, cognitive symptoms, psychotic symptoms, and depressive symptoms in veterans with ptsd.


Eligibility criteria:
inclusion criteria: * outpatient veterans with posttraumatic stress disorder (ptsd) * receiving treatment with an antidepressant at a stable dose for 4 weeks * male or female * ages 18-65 years old

Keywords: ptsd antidepressant aripiprazole oef oif
a smartphone-assisted brief behavioral intervention for pregnant women with depression

Conditions: Perinatal Depression

Summary: investigators developed motherly 1.0, a smartphone app designed to treat and promote maternal mental health. a 2-arm parallel-randomized controlled clinical trial (rct) will be conducted to test the efficacy of motherly in conjunction with brief cognitive-behavioral therapy. 70 pregnant women between 16-40 years old will be recruited. since all interventions will be conducted online, participants will be recruited from any brazilian state or municipality. participants will be randomly assigned to either receive intervention via app consisting of behavioral activation and psychoeducation to promote changes in sleep, nutrition, and physical activity habits, as well as to engage in prenatal care, breastfeeding, and social support, and to stimulate child development, in addition to brief cognitive-behavioral therapy (cbt) (n=35); or to a comparison group receiving an psychoeducational app (active control) with psychoeducational content about gestation, maternal health and mental health, and child development in addition to brief cbt (n=35). duration of treatment will be eight weeks, during which participants in both groups will be assessed at the beginning (baseline; t0), weeks 3-4 (midpoint; t1), and week 8 (endpoint; t2) in order to evaluate treatment effects. a follow-up postnatal assessment will also be conducted when the child is three months of age (t3).


Eligibility criteria:
inclusion criteria: * women aged between 16-40 years; * having a score of \>7 on the edinburgh postnatal depression scale (epds); * gestational age between 17-26 weeks; * being literate; * owning a functional smartphone with android for personal use. exclusion criteria: * pregnancies classified as being at risk, fetal malformation, or congenital disease; * visual, auditory or intellectual disabilities, or chronic diseases associated with fetal development alterations; * severe and/or chronic mental disorder (e.g., schizophrenia, bipolar disorder, etc).
the effect of s-ketamine combined with sufentanil for postoperative analgesia in patients following cesarean section

Conditions: S-ketamine; Analgesia, Patient-Controlled; Cesarean Section

Summary: this randomized controlled trial is designed to investigate the effect of low-dose of s-ketamine combined with sufentanil for postoperative patient-controlled intravenous analgesia in patients following cesarean section.


Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) physical status ii * patients aged between 20 and 40 years * 18 kg/m² ≤bmi≤30 kg/m² * singleton term pregnancy * scheduled for elective cesarean section exclusion criteria: * refused to participant in this trial * severe heart dysfunction or pulmonary insufficiency * poor blood pressure control in those with hypertension (bp \>160/100 mmhg in the ward) * previous history of intracranial hypertension or hyperthyroidism * previous history of schizophrenia, epilepsy, myasthenia gravis or delirium * allergy to drugs used in the study
first in human study to evaluate the safety and tolerability of gem103 in geographic atrophy secondary to dry age related macular degeneration

Conditions: Dry Age-related Macular Degeneration; Geographic Atrophy; Macular Degeneration; Retinal Disease; Retinal Degeneration

Summary: the study is designed to identify the maximum tolerated dose (mtd) for intravitreal (ivt) administration of gem103 in subjects with geographic atrophy (ga) secondary to dry amd. safety and tolerability of a single dose of gem103 will be assessed based on the occurrence of dose-limiting toxicities (dlts). each subject will be followed for safety, pharmacokinetic (pk), clinical, and biomarker evaluations. three escalating dose cohorts are planned.

this is a phase 1, multicenter, open-label, single-dose, dose-escalation study in subjects with ga secondary to dry amd to investigate the safety, tolerability, pharmacodynamics (pd), and immunogenicity of ivt injections of gem103 to a single eye. the study is designed to identify the mtd for ivt administration of gem103. safety and tolerability of a single dose of gem103 will be assessed based on the occurrence of dlts. three escalating dose cohorts are planned. subjects will undergo clinical and ophthalmic assessments for inclusion eligibility into the study. enrolled subjects will receive gem103 and be followed for safety, pk, clinical, and biomarker evaluations.

Eligibility criteria:
inclusion criteria: 1. at least 50 years old at the time of signed informed consent 2. able to cooperate sufficiently for adequate ophthalmic visual function testing and anatomic assessment and provide informed consent prior to initiation of any study procedure 3. best corrected visual acuity (bcva) in study eye between 5-45 letters 4. confirmed diagnosis of central ga in the study eye and eligible total ga lesion size exclusion criteria: 1. presence of the following ocular conditions - in the study eye: * exudative amd or choroidal neovascularization (cnv) * any ocular disease or condition that could impact the subject's ability to participate in the study or be a contraindication to ivt injection * any intraocular surgery (with the exception of intraocular lens replacement surgery more than 3 months prior to consent) 2. presence of any of the following ocular conditions - in either eye: * history of herpetic infection * ongoing treatment with antiangiogenic therapies in the fellow eye or completed treatment in the study eye 3. any prior or ongoing medical condition (e.g. ocular other than dry amd, systemic, psychiatric) or clinically significant screening laboratory value that may present a safety risk, interfere with study compliance, interfere with consistent study follow-up, or confound data interpretation throughout the longitudinal follow-up period 4. female subjects must not be pregnant or lactating 5. current use of medications known to be toxic to the lens, retina, or optic nerve
vytorin reexamination study (0653a-174)

Conditions: Primary Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH)

Summary: this survey is conducted for preparing application material for re-examination under the pharmaceutical affairs laws and its enforcement regulation, its aim is to reconfirm the clinical usefulness of vytorin through collecting the safety and efficacy information according to the re-examination regulation for new drugs.


Eligibility criteria:
inclusion criteria: * participants who receives vytorin in usual medical practice within local label for the first time

Keywords: atherosclerosis
optimising colorectal cancer screening participation

Conditions: Colorectal Neoplasms

Summary: the aim of this study is to demonstrate the effectiveness of three and four-staged invitation procedures compared to two-staged procedures by combining pre-notifications and reminders. the rct will be nested into the danish colorectal cancer screening programme in the central denmark region including men and women aged 50-74 years. participants will consecutively be randomized into four arms in a 1:1 ratio. intervention arm 1 will receive a pre-notification approximately ten days prior to intervention, invitation and one reminder (three-staged intervention), intervention arm 2 will receive invitation, one reminder after 45 days and a second reminder three months after invitation (three-staged invitation procedure), intervention arm 3 will receive pre-notification, invitation, reminder after 45 days and reminder after three months (four-staged invitation procedure). finally, the forth arm will be a control group receiving usual care which invitation and one reminder 45 days after invitation (two-staged invitation procedure). both pre-notifications and reminders are sent using digital mail. the main out-come will be participation within 6 months after invitation.


Eligibility criteria:
inclusion criteria: * invited for colorectal cancer screening exclusion criteria: -

Keywords: mass screening
the effect of abobotulinum toxin a on the symptoms of raynaud's phenomenon

Conditions: Raynaud Phenomenon

Summary: this study aims to investigate the effect of abobotulinum toxin a on the symptoms of raynaud's phenomenon.

this prospective double-blind randomized control trial seeks to compare a single formulation of bont, aboboutlinum toxin a (dysport), to a placebo saline group, studying the effect of bont on raynaud's symptoms among a more diverse population to provide insight into the patients most likely to benefit from bont.

Eligibility criteria:
inclusion criteria: * male or female adult between 18 and 80 years of age * must have health insurance * must have a current diagnosis of raynaud's phenomenon exclusion criteria: * allergy to abobotulinum toxin a or its components * diagnosis of myasthenia gravis * previously received abobotulinum toxin vaccine * previously undergone upper extremity vascular surgery (including surgical sympathectomy) * currently receiving aminoglycoside antibiotics * received abobotulinum toxin a treatment in either hand in the past 6 months * pregnant women * women currently breastfeeding * current tobacco smoker (use in the past 12 months) * unable to read and speak english * adults unable to consent * individuals who are not yet adults (infants, children, teenagers) * prisoners

Keywords: raynaud phenomenon abobotulinumtoxina
neurophysiology of cough reflex hypersensitivity

Conditions: Cough; Healthy Controls

Summary: central sensitisation is an increase in the excitability of nerves within the central nervous system, which can lead to heightened sensitivity to certain stimuli. this process is involved in some chronic pain conditions e.g. migraines and non-cardiac chest pain. recent work by our group suggests central sensitisation may be an important mechanism leading to chronic cough. the main questions in this study include: 1. can the investigators induce temporary central sensitisation of the cough reflex in healthy volunteers for testing of new medications? 2. can the investigators demonstrate exaggerated sensitisation in patients with chronic cough (indicating these patients are already centrally sensitised)? in animal studies, acid infusion into the gullet (oesophagus) is able to induce central sensitisation of the cough reflex. acid infusion into the oesophagus has also been shown to induce central sensitisation in human healthy volunteers, increasing the sensitivity to pain on the front of the chest but this study did not test the the cough reflex. using human participants, the investigators plan to test whether acid infusion into the oesophagus increases the sensitivity of the cough reflex in healthy volunteers and also patients complaining of chronic cough.


Eligibility criteria:
inclusion criteria: healthy volunteers inclusion: * over 18 years * measurable cough reflex sensitivity - required as is the primary end-point * no current or past history of chronic cough or chronic respiratory disease chronic cough patients inclusion: * over 18 years * chronic persistent cough (\> 8 weeks) despite investigation and/or treatment trials for cough variant asthma/post-nasal drip and gastro-oesophageal reflux * normal chest radiograph - primary respiratory cause for cough excluded * normal lung function - primary respiratory cause for cough excluded measurable cough reflex sensitivity - required as primary end-point exclusion criteria: * recent upper respiratory tract infection (\<4 weeks) - this can lead to increased sensitivity of the cough reflex which resolves as the infection settles * pregnancy/breast-feeding - unknown effects of oesophageal acid infusion * current smokers or ex-smokers with \ 20 pack years - smoking can alter the sensitivity of the cough reflex * opiate or ace inhibitor use or centrally acting medication - can alter the cough reflex sensitivity * symptomatic gastro-oesophageal reflux, post-nasal drip or asthma (chronic cough cohort may have been treated for these in the past but cough did not resolve) - these conditions are known to cause cough and alter cough reflex sensitivity * significant ongoing chronic respiratory/cardiovascular/gastro-intestinal/haematological/ neurological/psychiatric illness. we are aiming to recruit healthy volunteers and chronic cough patients who are otherwise healthy
daytime impact sleep study

Conditions: Nocturia

Summary: this trial will investigate the relationship of sleep, daytime performance and nocturia in patients treated with desmopressin or placebo. male and female patients will be administered desmopressin or placebo every day for 3 months.


Eligibility criteria:
inclusion criteria: * at least 2 night time voids per night * habitual sleep of 6-9.5 hours per night * experiencing symptoms of nocturia greater than 6 months exclusion criteria: * greater than 10 night time voids * history of sleep apnoea and plms (periodic limb movements of sleep) * other sleep disorders * signs or symptoms of: bladder outlet obstruction, severe lower urinary tract symptoms (luts), interstitial cystitis, moderate to severe overactive bladder (oab), moderate to severe as judged by the investigator stress urinary incontinence * urological malignancies * neurogenic detrusor over activity (e.g. parkinson, spinal cord damage, etc.) * central or nephrogenic diabetes insipidus * habitual or psychogenic polydipsia (fluid intake resulting in a urine production exceeding 40ml/kg/24hrs) * syndrome of inappropriate antidiuretic hormone (siadh) * cardiac failure evidence based on physical examination, cardiac medical history and electrocardiogram (ecg) output * uncontrolled hypertension * uncontrolled diabetes mellitus * hyponatraemia with sodium \<135 mmol/l * renal insufficiency * known or suspected clinically significant hepatic and/or biliary diseases
desmopressin and dexamethasone adjunctive treatment for leptospirosis

Conditions: Leptospirosis

Summary: background: pulmonary involvement in leptospirosis has been reported to be on the increase and is emerging as the main cause of death due to leptospirosis in many countries, including thailand. methods: a prospective randomized controlled trial of desmopressin or high dose dexamethasone as adjunctive therapy in patients with suspected pulmonary hemorrhage associated with leptospirosis was conducted between july 2003 and october 2006 at 5 hospitals in thailand.


Eligibility criteria:
inclusion criteria: * adult patients (\> 14 years) with suspected severe leptospirosis * patients who presented with acute fever (oral temperature more than 38.00 c for \<15 days) in the absence of an obvious focus of infection * in the opinion of the attending physician might have pulmonary hemorrhage (i.e. history of hemoptysis, and/ or bilateral nodular or air space infiltration). exclusion criteria: * pregnant or breastfeeding * those with history of bleeding disorder * those who had underlying diseases such as chronic liver disease, diabetes mellitus * those who received diuretic or glucocorticoid

Keywords: severe leptospirosis pulmonary hemorrhage
an analysis of treatment timelines for lung cancer patients across system evolutions

Conditions: Lung Cancer

Summary: this study is a single center, minimal risk, physician initiated retrospective chart review. an analysis of treatment timelines for patients diagnosed with lung cancer within the st. elizabeth system from january 2013 until study completion. the study investigator and designee(s) will review patient electronic medical records, extracting data related to the symptom presentation, diagnosis, and treatment of new diagnoses of lung cancer. collected data will focus on dates of encounters, diagnostic imaging/procedures, and treatments, with data analysis evaluating time between care encounters and potential delays in care. the data will be further stratified based on system-wide changes implemented to improve efficiency, patient outcomes, and patient experience.


Eligibility criteria:
inclusion criteria: * patient seen within the st. elizabeth system * \>=18 years of age * new diagnosis of histologically or cytologically documented primary lung cancer diagnosed january 2013 or later exclusion criteria: * patients with metastatic lung disease of other primary * other malignancies at investigator's discretion * patient received treatment at a facility outside of st. elizabeth where records are not available through epic * patient currently undergoing treatment for new diagnosis of lung cancer