Kornimate/medical-research-clean huggingface dataset:
subretinal lucentis for hemorrhagic age-related macular degeneration (amd)

Conditions: Retinal Hemorrhage; Macular Degeneration

Summary: visual outcomes of the eye with large subretinal hemorrhages (bleeding under the retina) due to age-related macular degeneration (amd) are poor. the submacular surgery trial (sst) showed that no statistically significant improvement in vision resulted from surgical removal of the layer of abnormal blood vessels causing the bleeding. however, placement of a gas bubble into the gel of the eye along with removal of the blood has shown some success. however, this does not treat the underlying condition of the amd. intravitreal injections (into the gel of the eye) of a drug called lucentis has been shown to be highly effective in the treatment of amd, yet its penetration through areas of thick blood caused by subretinal hemorrhage is not known. this study is proposing to treat the amd causing the subretinal hemorrhage with a vitrectomy (surgery involving removing the gel inside the eye, and membrane layers of the eye) followed by lucentis placed between the layers of the retina and then with or without a gas bubble. in order to determine if the the subretinal lucentis alone is beneficial, 5 of the 10 patients enrolled will get a gas bubble and the other 5 will not.

subjects will be followed for a period of 12 months. based on photographs and other testing procedures, if it is deemed in the subject's best interest, the subject may receive monthly injections of lucentis to help treat the amd.

Eligibility criteria:
inclusion criteria: * age over 50 years * vision 20/200 or worse * amd with submacular hemorrhage * hemorrhage more than 25% of the lesion * fibrosis or scar not more than 25% of the entire lesion * hemorrhage less than 3 months old * vision loss occuring within 3 months exclusion criteria: * pregnancy * participating in any other clinical trial * prior treatment for amd * other medical conditions causing compromised vision * intraocular eye surgery within the previous 12 months * inability to obtain necessary eye photographs * systemic use of anti-vegf agents * allergy to fluorescein dye * unable to complete all study visits * glaucoma filtering surgery * use of 2 or more treatments for glaucoma * lack of lens in the eye or absence of a posterior capsule

Keywords: macular degeneration amd hemorrhage wet amd
safety, tolerability and effects of mannitol in parkinson's disease

Conditions: Parkinson Disease

Summary: parkinson's disease is a progressive neurodegenerative disease that causes disabling motor and cognitive impairments. currently, no disease-modifying therapy exists for this disease. mannitol, a naturally-occurring substance, which is commonly used as sweetener, was offered as such agent. in this phase ii, safety, tolerability-based dose finding, and efficacy study, mannitol or placebo (dextrose) in escalating doses will be given to patients with parkinson's disease for 36 weeks.


Eligibility criteria:
inclusion criteria: 1. ability to understand and signing of informed consent form. 2. age 40-75 years at the day of visit 1. 3. diagnosis of parkinson's disease that is based on the united kingdom brain bank criteria diagnosed after the age of 40. 4. stable regime of anti-parkinsonian medication for at least 4 weeks at the day of visit 1. exclusion criteria: 1. patients with motor deficits that require administration of symptomatic therapy more than 4 times per day at the day of visit 1. 2. patients on advanced therapy for parkinson's disease (sub-cutaneous apomorphine, deep brain stimulation or intra-jejunal levodopa infusion). 3. patients with dementia reflected by a mini-mental state examination (moca) ≥ 24. 4. patient with legal guardian. 5. history of psychosis or use of dopamine receptor blocking agent on the year proceeding at the visit 1. quetiapine at dose lower or equal 50 mg per day prescribed for indication other than psychosis is allowed. 6. suspected parkinsonian syndrome other than parkinson's disease. 7. use of medical marihuana on the month proceeding visit 1. 8. pregnant or lactating women, or fertile woman who does not use contraceptive. woman of child-bearing potential must have a negative urine human chorionic gonadotropin (hcg) and will be monitored by repeated urine tests. 9. patient with significantly impaired renal functions (urea or creatinine values 20% above the upper norm limit). 10. diabetes mellitus. 11. clinical evidence for congestive heart failure. 12. patient with symptomatic orthostatic hypotension. 13. based on investigator's opinion, any medical condition that may progress due to consumption of oral mannitol or glucose.
evaluate the effect of saxagliptin on gut microbiota in patients with newly diagnosed type 2 diabetes

Conditions: Type 2 Diabetes; Obesity

Summary: the intestinal microflora imbalance has been associated with obesity and type 2 diabetes. the researchers' study aimed to investigate the effect of saxagliptin on gut microbiota in patients with newly diagnosed type 2 diabetes.


Eligibility criteria:
inclusion criteria: * females or males, and aged 20 to 65 years. * newly diagnosed type 2 diabetes * hba1c ≥7% and hba1c \<9% exclusion criteria: * hepatic insufficiency (alt or ast\> 1.5\*uln) * renal insufficiency \[creatinine clearance rate (ccr)\]\<60ml/min estimated from mdrd equation) * coronary artery disease * thyroid disease * infectious disease * systemic inflammatory disease * cancer * subjects who were taking agents known to influence gut microbiota * pregnant or lactating woman * other conditions at investigator's discretion

Keywords: gut microbiota inflammatory marker glucose and lipid metabolism
brachial plexus nerve block versus haematoma block for closed reduction of distal radius fracture in adults - the block trial. a multicentre randomised controlled trial.

Conditions: Distal Radius Fractures; Fracture Dislocation; Fracture Dislocation of Upper Limb Joint; Colles' Fracture; Closed Reduction of Fracture and Application of Plaster Cast

Summary: the aim of the project is to evaluate the beneficial and harmful effects of an ultrasound-guided brachial plexus nerve block for patients with a distal radius (wrist) fracture in the need of realignment of fractured bone endings without cutting the skin (closed reduction), in comparison to a haematoma block, which is standard care in denmark. every participant will receive one of the following types of anaesthesia for the realignment of the wrist fracture: 1. a nerve block of the arm (plexus brachialis block) 2. a haematoma block, which is the current standard anaesthesia in the emergency departments.


Eligibility criteria:
inclusion criteria: * adults (age ≥ 18 years) with a distal radius fracture in need of closed reduction exclusion criteria: * patients who would never qualify for surgery according to local guidelines * lack of informed consent * no danish central person register (cpr) number * allergies to the trial medication * distal radius fracture initially deemed to require surgery regardless of the outcome of the closed reduction * open fractures (fracture-related wound requiring sutures) * other fractures on the same extremity ((not including distal ulna fracture(s)) * bilateral distal radius fractures both requiring closed reduction * concomitant medical or surgical condition taking priority over the closed reduction of the distal radius fracture.

Keywords: lidocaine local anaesthesia regional anaesthesia peripheral nerve block brachial plexus block lateral infraclavicular block axillary plexus block distal radius fracture colles' fracture wrist fracture
proximal interphalangeal joint arthroplasty using a graft from the capitate

Conditions: Recurrent Dislocation of Hand

Summary: the capitate had a widened distal base. the distal articulation can be used for proximal interphalangeal (pip) articula reconstruction.

previous anatomical studies have shown that the capitate had a widened distal base. the distal articulation was mainly with the base of the third metacarpal and partially with the base of the second metacarpal. the articulation was slightly flattened with a convex and concave dorsal articular surface. the contour stimulates our imagination and creativity to use a portion of the articular surface for pip arthroplasty.

Eligibility criteria:
inclusion criteria: 1. an articular defect at the proximal aspect of the pip joint; 2. the defect larger than 5 mm × 5 mm in size based on intraoperative findings. exclusion criteria: 1. large defects involved double joint surfaces; 2. the size of the defect less than 5 mm × 5 mm; 3. mult-digital articular defects that all required osteoarticular grafting; 4. associate with infection or other diseases that restrict to use the technique.

Keywords: arthroplasty graft capitate artery
nordic cystectomy study ii - albumin

Conditions: Bladder Cancer; Invasive Bladder Cancer

Summary: around 7200 cases of muscle invasive bladder cancer are diagnosed annually in the nordic countries combined. muscle invasive bladder cancer is an aggressive disease and it is linked with high mortality rates. the golden standard of treatment is radical cystectomy (rc) (the surgical removal of the bladder) and radical removal of lymph nodes in the pelvis. in addition to surgical treatment, and especially in cases where the tumour invades tissues surrounding the bladder or lymph nodes, chemotherapy is recommended. chemotherapy can be administered before or after surgery, in a neoadjuvant (nac) or adjuvant setting (ac). although most patients recover well from surgery, there are significant risks regarding radical cystectomy. the greatest challenges in planning the treatment are making individual risk assessments and prognosis for the treated patients. neoadjuvant chemotherapy is also insufficiently used and it is hard to predict how the tumour responds to chemotherapy. the purpose of this study is to collect prospective clinical data on radical cystectomy -patients in co-operation with other nordic countries: sweden, denmark, iceland and norway. the collected data is used to validate existing prediction tools and discover novel tools for prediction of morbidity related to rc and prediction of oncological outcome after rc. the study is divided into three sub-studies. the first sub-study is to validate low albumin levels as a predictor of complications after rc . the cut-off for low albumin has been \<3,5 mg/l across the studies. this could be a very cost-effective biomarker but currently its relevance is limited by lack of proper prospective validation studies. the primary end-point in the albumin sub-study is the 90-day major (clavien dindo 3-5) complication rate. the secondary end-points include total 90-day complication (clavien 1-5) and 90-mortality rate (clavien 5) for all patients and complication rate during nac for patients receiving chemotherapy.


Eligibility criteria:
inclusion criteria: 1. histologically confirmed urinary bc planned to be treated with rc with or without neoadjuvant chemotherapy. 2. histologically confirmed urinary bc planned to be treated with palliative cystectomy 2) signed informed consent 3) patient age \>18 years exclusion criteria: 1. rc for other reasons than bc 2. other forms of surgical treatment of bc than rc (e.g. bladder resection). 3. patient unwillingness to participate in the study for any reason (i.e. lack of signed consent).
effect of low-level laser therapy versus shock wave therapy on pain and function in patients with chronic non-specific low back pain

Conditions: Low Back Pain

Summary: a significant global source of disability is low back pain. maladaptive variations in the level of activity in the lumbar musculature are one thing that could possibly contribute to persistent pain.


Eligibility criteria:
inclusion criteria: 1. all patients will suffer from mechanical low back pain 2. age will range from 20 to 40 years 3. all patients will have bmi range from 20-24 exclusion criteria: 1. history of radicular pain 2. lumbar disc prolapse. 3. visual problems 4. history of previous lumbar surgery 5. bmi more than 24

Keywords: low-level laser therapy shock wave therapy pain function chronic non-specific low back pain
prostate-specific membrane antigen (psma) pet scans in people prostate cancer

Conditions: Prostate Cancer; Prostate Neoplasm; Prostate Adenocarcinoma; Prostate Cancer Metastatic; Metastatic Prostate Cancer

Summary: the purpose of this study is to determine if prostate-specific membrane antigen (psma) positron emission tomography (pet) scans used in this study accurate and better at imaging participants' prostate cancer than the usual methods.


Eligibility criteria:
inclusion criteria: * patients with histologically confirmed prostate cancer, that is either: newly diagnosed or progressive as defined by standard pcwg3 criteria. note that metastatic disease is defined by either bone scintigraphy or by ct or mri, or a combination of these tests, but not exclusively by molecular imaging criteria. patients with newly diagnosed localized or metastatic prostate cancer are eligible, provided standard imaging (either bone scintigraphy, ct or mri) demonstrates evidence of radiographic disease patient with progressive disease that is non-metastatic are eligible by biochemical progression: a minimum of three rising psa values from a baseline that are obtained 1 week or more apart, or 2 measurements 2 or more weeks apart patients with progressive disease that is metastatic are eligible either by biochemical progression or radiographic progression or both patients are permitted to have had up to 2 months of prior hormonal therapy before entering this trial (and many therapeutic trials) and therefore, their progression criteria would apply to their pre-treatment imaging and psa parameters note: this criterion pertains to patients with newly diagnosed, untreated disease. this criterion does not apply to those who were already on therapy for metastatic crpc. * karnofsky performance status of \>/= 50 (or ecog/who equivalent) * male (or transgender female) \> 18 years of age * patient must be able to understand and willing to sign a written informed consent document * patient is anticipating starting a therapeutic strategy following imaging exclusion criteria: * patient undergoing active treatment for non-prostate malignancy, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and non-invasive bladder cancer * unable to lie flat, still or tolerate a pet scan

Keywords: prostate cancer metastatic prostate cancer pcwg3 18 f-dcfpyl 68 ga-psma 19-170 memorial sloan kettering cancer center
a phase 3 study of spl7013 gel (vivagel) for the treatment of bacterial vaginosis

Conditions: Bacterial Vaginosis

Summary: the primary objective of the study is to assess the efficacy of 1% spl7013 gel compared to placebo gel for the treatment of bacterial vaginosis (bv). after screening eligible participants will be randomized to receive either 1% spl7013 gel or hydroxyethyl cellulose (hec) placebo gel at a dose of 5g administered vaginally at bedtime for 7 consecutive days. participants will be assessed for bv (both by amsel criteria and nugent score) at screening/baseline, after last application (end of treatment, eot, day 9-12) and at the final study visit approximately 2-3 weeks after last dose (test of cure, toc, day 21-30).


Eligibility criteria:
key eligibility criteria: * post-menarchal females, aged 12 years or more * diagnosis of bv by amsel criteria (ie all four of the following signs/symptoms: presence of white to grey homogeneous discharge; positive whiff test indicating an amine (fishy) odor with addition of potassium hydroxide; vaginal ph greater than 4.5; and presence at least 20% clue cells of total epithelial cells * nugent score of at least 4 * otherwise healthy, as determined by medical history, physical examination * normal pap smear at or documented within 24 months of screening

Keywords: spl7013 vivagel bacterial vaginosis bv
visual recognition of allergens by allergic patients and/or their parents

Conditions: Nut Allergy; Peanut Allergy

Summary: food allergies are constantly increasing. peanut and nut allergies are a major cause of allergic reactions. diagnosed patients are also at risk, because 27% of the patients that had an allergic reaction have another one in the following year with the same food, despite a real improvement in industrial products labeling. the investigators have observed in the allergy unit that patients (and/or their family) following an elimination diet, sometimes since several years, use very strict elimination strategies. those strategies sometimes lead to incapacities to recognize the allergens. yet, a good identification of the allergen is the key to a successful elimination and the non-identification a known risk factor. ferdman shown in 2006 that 27% of the patients didn't recognize the allergen there were allergic to. however, this is a us study, and geographical specificities have an impact on food consumption and culture. food allergology needs to take those two elements into account. for example, in france, a single food can have two names. it is the case of peanut, which can be called "arachide", or more frequently "cacahuète". the goal of the study is to observe patient aptitudes to recognize peanut (and the association between the two names) and other nuts available in france and define by the european law, using a plate with various food samples in seed or in shell. thus, patients in care at the allergy unit of saint vincent hospital of lille (france) and their families were surveyed with a standardized procedure at the beginning of their therapeutic education and their capacity to recognize various nuts, to identify peanut ("cacahuète" or "arachide") and to associate the two words "cacahuète" and "arachide" was assessed. it is a standard procedure in therapeutic education, and the responses have been systematically entered in the medical record. the main objective of this study is to describe peanut or nut allergic patient capacity (adult, children and/or the family) to visually identify the foods there are allergic to. the secondary objective of this study is to describe the capacity of patient that describe themselves as allergic to "arachide" to associate this word to the word "cacahuète".


Eligibility criteria:
inclusion criteria: * peanut or nut allergy * following an elimination diet since at least 3 months * results obtained at the beginning of a therapeutic education started from 2013 to 2015 exclusion criteria: * patients opposed to enter the study
fixed combination of dipirone and codeine compared to the isolated use of dipyrone and codeine in controlling pain after pelvic-abdominal surgery.

Conditions: Pain, Postoperative

Summary: phase iii clinical trial, multicentre of superiority, randomized, open, parallel groups, with active control and use of postoperative oral medication (multiple doses of medication).

the main objective is to evaluate the effectiveness and safety of the association in relation to the isolated use of medicines.

Eligibility criteria:
inclusion criteria: * ≥ 18 years; * patients in the 1st postoperative period of open abdominal or pelvic surgery (last 24 hours) and receiving short duration analgesics or opioids in any route of administration on the previous day, being able to receive oral medication and scheduled home discharge in hours or days, with pain moderate to intense intensity (defined as vas pain ≥ 4); * have signed the informed consent form. exclusion criteria: * surgical complications to the inclusion of the participant in the research; * other serious comorbidities at the discretion of the investigators (such as a history of renal, hepatic, cardiac or other peptic ulcer); * history of chronic and current use of opioids or other analgesics; * users of alcohol or illicit drugs; * use of drugs with the potential to interact with study drugs; * allergy, hypersensitivity or known contraindication to the use of components of the study drug; * psychiatric or social disorders that prevent adequate follow-up to the protocol; * show inability to understand and perform current pain assessments in the study; * women of childbearing potential, defined as all physiologically capable women of childbearing, unless they are using effective contraceptive methods while administering study medication; * any clinical condition that the investigator considers to generate risk to the patient or interfere with the conduct of the study; * participation in another clinical study in less than a year (unless participation by the principal investigator is justified).

Keywords: dipirone codeine pain
clear synergy neutrophil substudy

Conditions: Neutrophils.Hypersegmented &#X7C; Bld-Ser-Plas; STEMI - ST Elevation Myocardial Infarction

Summary: clear synergy is an international multi center 2x2 randomized placebo controlled trial of colchicine and spironolactone in patients with stemi. subjects enrolled in the main clear synergy trial will be asked to participate in this sub study (n=670) to undergo: 1. evaluation of markers of neutrophil activity at randomization (baseline) and 3 months follow-up in the colchicine versus placebo groups, and; 2. examination of clinical and genetic factors that determine heterogeneity of treatment response and distinguish colchicine responders from non- responders. participants undergo a blood draw at baseline and 3 months follow-up as part of the main trial, and participants who also participate in this sub study will have an additional 2 tablespoons of blood drawn. the sub study objectives are to: 1. assess the effect of colchicine on neutrophil activation in response to stemi. 2. examine clinical and genetic factors that determine heterogeneity of treatment response anddistinguish colchicine responders from non- responders. 3. explore the derivation of a risk score that includes markers of neutrophil activity and is associated with adjudicated mace over 3 years after stemi, and assess the impact of colchicine on the relation between this risk score and mace.


Eligibility criteria:
inclusion criteria: * patients who are randomized to the drug rct portion of the clear synergy (oasis 9) trial will be eligible for participation in this neutrophil biomarker substudy. exclusion criteria: * use of anti-inflammatory agents (except aspirin) * active infection
cardiac autonomic reactivity and behavioral response to pain in full-term neonates

Conditions: Pain

Summary: background: heel lancing is a routine procedure for the diagnosis of phenylketonuria in infants. despite the short- and long-term adverse effects of pain, there are no guidelines for the reduction of such pain. previous studies evaluated different treatment modalities; however, in most of them, pain response was assessed by subjective measures. aims of study: 1. to characterize the pain response of infants by using a computerized analysis of the ecg. 2. to compare six different methods of pain reduction during heel lancing in newborns. methods: the time, geometric and frequency domains of the infants' ecg will be computed during heel lancing. 150 healthy full-term infants will be evaluated in six treatment groups: breastfeeding, bottle feeding, skin-to-skin contact, lying on a table without anything, lying with a pacifier and lying while getting a glucose solution. the differences in pain response to these six treatment modalities will be assessed and compared to the infants' length of cry, and scoring of the infants' behavioral response.


Eligibility criteria:
inclusion criteria: * normal full-term newborns (\>38 weeks) * apgar score \>=8 at five minutes after delivery. exclusion criteria: * congenital anomalies * medical complications * need for oxygen administration