Kornimate/medical-research-clean huggingface dataset:
ibeat wristwatch validation study

Conditions: Arrythmia, Cardiac

Summary: the ibeat study is a single-center, prospective, unblinded validation of the photoplethysmography (ppg) and tissue oximetry (to) signal waveforms recorded from a wrist-based sensor devices.

the goal of the proposed research is to validate ppg and to signal waveforms recorded from a wist-based sensor device, which is worn on one or both arms, during catheter ablation, device interrogation, and defibrillation threshold testing (dft). it is a non-invasive procedure that will include placing a wrist-based sensor on subjects who consent participate. data collected from routine clinical care devices used during these procedures (catheter ablations, device interrogations, and dfts) will confirm data collected from the ibeat wristwatch.

Eligibility criteria:
inclusion criteria: 1. age ≥ 21 years and ≤ 85 years 2. able to understand and give informed consent. 3. subject is presenting for the following planned procedures: 3.1 group a (25 subjects): subjects presenting for catheter ablation for cardiac arrhythmias (e.g. atrial fibrillation, supraventricular tachycardia, or ventricular tachycardia) 3.2 group b (25 subjects): subjects judged based on the clinical evaluation of high, greater than 75%, atrial pacing or ventricular pacing burden or known pacing dependence with planned device interrogation for: 1) pacemaker (single or dual chamber), 2) implantable cardioverter-defibrillator (single or dual chamber), or 3) cardiac resynchronization therapy with or without defibrillator (single or dual chamber plus left ventricular pacing). 3.3 group c (5 subjects): subjects for clinically indicated defibrillation threshold testing (dft) (with a transvenous or subcutaneous icd lead system) exclusion criteria: 1. age \ 85 years 2. unable to or refuse to give written informed consent 3. unwilling or unable to wear the smartwatch device on at least one wrist 4. uncorrected severe aortic stenosis or subaortic stenosis (including hypertrophic cardiomyopathy) with outflow tract obstruction \> 50 mm 5. new york heart association class iv heart failure

Keywords: ibeat wrist watch digital health arrythmia
chart review of the efficacy of the genesisplus 1064 nm nd:yag laser in the treatment of onychomycosis

Conditions: Onychomycosis

Summary: the purpose of this study is to determine if toenail onychomycosis can be reduced by means of exposure to laser energy from the cutera® genesisplus 1064 nd:yag laser system.

this is a retrospective, open-label, single-centre study for the collection of clinical data on the efficacy and safety of the cutera® genesisplus 1064 nm nd:yag laser for the treatment of nail fungus (onychomycosis). safety and efficacy of treatment with the genesisplus laser will be evaluated by (1) assessment of subject's great toenail photographs at baseline and after two treatments with genesisplus laser utilizing planimetry measurement of infected vs. clear nail area in target toenail photographs, (2) by clinical and subjective review of acute and follow up adverse events that may have resulted from laser treatment of the target toenails.

Eligibility criteria:
inclusion criteria: 1. male or female subjects, age 18 to 80 years (inclusive). 2. subject with a clinical diagnosis of onychomycosis of one or both great toenails at baseline. 3. subject with a positive potassium hydroxide (koh) stain and/or fungal culture. 4. subject has baseline and post treatment digital photographs of target great toenails. 5. subjects provided informed consent for treatment of nails with the cutera genesisplus laser system. exclusion criteria: 1. subjects have received laser treatment of the infected great toenail(s) with a non-cutera® laser system within twelve (12) months prior to cutera® genesisplus laser treatment. 2. subjects have had a history or clinical diagnosis of moccasin type tinea pedis, lichen planus, psoriasis or bacterial nail infection. 3. subjects had a history or clinical diagnosis of coexisting disorders that may potentially demonstrate nail manifestations. 4. systemic antifungal medication within six (6) months prior to or following cutera® genesisplus laser treatment. 5. subjects who have had a history or clinical diagnosis of repetitive nail trauma prior to treatment. 6. subjects who have participated in any clinical research study within thirty (30) days prior to or within 210 days following final cutera® genesisplus laser treatment. 7. subjects who were pregnant or breastfeeding.
surgery for gastrointestinal metastases of malignant melanoma - a single center retrospective cohort study

Conditions: Melanoma Stage Iv; Melanoma Metastatic; Abdominal Tumor

Summary: the aim is to conduct a single centre retrospective study of all patients with stage iv melanoma that underwent surgery for metastases at sahlgrenska university hospital between 2010-01-01 and 2018-12-31. pre- and postoperative data will be collected from digital medical records, the swedish cancer registry, the swedish cause of death register as well as from the national swedish cancer patient database (inca). if needed, patient records will be collected from other hospitals. results will be presented in written format as a summary and analysis of the characteristics of the cases operated on during the inclusion period. the aim is to identify predictive and prognostic factors for outcome and complications in the surgical treatment of stage iv metastatic melanoma.


Eligibility criteria:
inclusion criteria: * biopsy verified stage iv malignant melanoma, stage m1c. * having undergone surgery with metastasectomy of melanoma tumors. exclusion criteria: * retroperitoneal tumors

Keywords: melanoma abdominal metastasis metastasectomy tumor resection m1c
study of amg 330 in combination with pembrolizumab in adult with relapsed or refractory acute myeloid leukemia

Conditions: Relapsed or Refractory Acute Myeloid Leukemia

Summary: the primary objective of this study is to evaluate the safety and tolerability of amg 330, administered in combination with pembrolizumab, in participants with relapsed or refractory acute myeloid leukemia (r/r aml).

this study will assess the safety and tolerability of amg 330 in combination with pembrolizumab and whether pembrolizumab will enhance the anti-aml activity of amg 330. both cohort 1 and 2 will include amg 330 and pembrolizumab with the difference being the initiation date for pembrolizumab treatment.

Eligibility criteria:
key inclusion criteria * aml as defined by the who classification persisting or recurring following one or more treatment courses. except apl * eastern cooperative oncology group (ecog) ≤1 key exclusion criteria * active extramedullary aml in the central nervous system. * known hypersensitivity to immunoglobulins. * non-manageable graft versus host disease.
a lot-to-lot consistency study to evaluate safety, tolerability, and immunogenicity of inactivated varicella zoster virus (vzv) vaccine in healthy adults (v212-014)

Conditions: Herpes Zoster

Summary: the study will evaluate the consistency of 3 lots of inactivated vzv vaccine for safety, tolerability, and immunogenicity in healthy adults. the primary hypothesis of the study is that the 3 lots of inactivated vaccine will demonstrate similar immunogenicity at 28 days after the fourth dose.


Eligibility criteria:
inclusion criteria: * afebrile (\<=100.4 °f \[\<=38.0 °c\]) oral or equivalent on day 1 before the first vaccination * any underlying chronic illness that is not in stable condition * history of varicella, antibodies to vzv, or residence (for \>=30 years) in a country with endemic vzv infection * female participants of childbearing potential must have a negative pregnancy test. a female not of reproductive potential has reached natural menopause, or is 6-weeks postsurgical bilateral oophorectomy and/or hysterectomy or bilateral tubal ligation * male, or female of childbearing potential who agrees to remain abstinent or use 2 acceptable methods of birth control from 2 weeks before enrollment to 6 months after the last study vaccination exclusion criteria: * history of allergic reaction to any vaccine component, or an anaphylactic/anaphylactoid reaction to neomycin (not including contact dermatitis to neomycin) * prior history of herpes zoster * history of receipt or expects to receive any varicella or zoster vaccine during the study period * is pregnant or breastfeeding, or expects to conceive from 2 weeks before enrollment to 6 months after the last study vaccination * has received a live virus vaccine or is scheduled to receive any live virus vaccine from 4 weeks before the first dose of study vaccination and throughout the study * has received any inactivated vaccine or is scheduled to receive any inactivated vaccine from 7 days before to 7 days after any study vaccination * received immunoglobulin or any blood products or is scheduled to receive them from 5 months before the first dose of study vaccination and throughout the study * has participated in an investigational drug or vaccine study within 30 days before enrollment * has any acute illness or significant underlying illness that may interfere with interpretation of the study * receiving immunosuppressive therapy (including systemic corticosteroid doses exceeding physiological replacement doses within 14 days prior to the first vaccination), except topical, ophthalmic, or inhaled corticosteroids or intra-articular or soft-tissue injections of steroids * has known or suspected immune dysfunction
confocal endomicroscopy for barrett's esophagus

Conditions: Barrett's Esophagus; Esophageal Adenocarcinoma

Summary: the purpose of this study is to determine if confocal laser endomicroscopy (cle) can improve detection of barrett's esophagus, dysplasia, and early esophageal cancer.

barrett's esophagus is a leading cause of esophageal adenocarcinoma. detection of dysplasia and early cancers in barrett's esophagus can be challenging, time-consuming and expensive. small lesions may be difficult to detect with standard endoscopy protocols. confocal laser endomicroscopy (cle) is a new type of endoscopy where a small confocal microscope is built into the tip of a standard endoscope. for this study, we are comparing confocal laser endomicroscopy (cle) with targeted biopsies with standard endoscopy (egd)and biopsy for barrett's esophagus to determine if cle is more effective for detecting dysplasia and cancer. participants with barrett's esophagus in this study undergo 1) cle with targeted mucosal biopsies (biopsy only taken if cle shows abnormal tissue) and 2) standard egd with biopsies. the order of procedures is randomized (some patients have cle first while others have standard egd first).

Eligibility criteria:
inclusion criteria: * barrett's esophagus or suspected barrett's-associated neoplasia * age \> 18 * able to give informed consent exclusion criteria: * known advanced malignant disease * allergy to the fluorescent contrast agent fluorescein sodium * coagulopathy or bleeding disorder

Keywords: barrett's esophagus esophageal adenocarcinoma endoscopy confocal laser endomicroscopy
artificial intelligence in colonic polyp detection

Conditions: Polyp of Colon; Adenoma Colon; Gastrointestinal Neoplasms

Summary: a randomized, controlled study investigating the potential benefits of artificial intelligence (ai) in the detection of colonic polyps during outpatient colonoscopy. randomization between the use of ai and no ai is performed before the study procedure.


Eligibility criteria:
inclusion criteria: * all patients without ibd referred for colonoscopy exclusion criteria: * age \< 40 years * not willing to participate

Keywords: colonoscopy artificial intelligence
mhealth to increase measles immunization - a randomized controlled trial in guinea-bissau

Conditions: Measles

Summary: the question that this project seeks to answer, is whether mobile phones can be used to increase the measles vaccination coverage and timeliness in guinea-bissau. the intervention will be evaluated in terms of direct health outcomes and cost/benefit analysis, generating evidence that could help policy makers making informed decisions about implementing mhealth interventions at a national level. the intervention takes the form of a randomized controlled trial in which text messages (sms) as well as voice calls are scheduled and delivered to mo thers to remind and encourage them to have their children timely vaccinated against measles. in addition, the messages will include relevant information about opening hours and availability of the measles vaccine at the mothers' local health facilities thus improving coordination. the trial will include three different randomization groups with approx. 350 participants in each group. the first group will receive sms messages, the second group will receive a voice call in addition to the sms messages, and the third group is a control group that does not receive any intervention. study participants will be enrolled following birth at one of three health centers in different rural regions of guinea-bissau. before the measles vaccine is scheduled to be given, at 9 months of age, mothers will receive the intervention message depending on their assigned randomization group. when the measles vaccine is administered, the child will be registered as having received the measles vaccination. a follow-up phone interview will be conducted at 12 months of age for all children participating regardless of randomization group and whether or not they received the measles vaccine. all participating children, who at that time still have not received the measles vaccine, will be offered the vaccine at the expense of the project.


Eligibility criteria:
inclusion criteria: * the mother has access to a cell phone (either her own phone or the phone of a household member) * the mother lives in the uptake area of the health center. exclusion criteria: * the mother does not have access to a mobile phone.

Keywords: mhealth mobile phones measles vaccination
self-propelled percutaneous endoscopic gastrojejunostomy (peg-j)

Conditions: GERD

Summary: this research is being done to study the safety of an investigational percutaneous endoscopic gastrojejunostomy (pegj) tube and whether the addition of a balloon on the end of the j tube prevents it from slipping back into the stomach.

the word "investigational" means the pegj feeding tube used in this study is not approved by the u. s. food and drug administration (fda) and is still being tested in research studies. currently commercially available pegj tubes are long tubes which are placed into the part of the small intestine that connects to the stomach (duodenum) under endoscopic guidance. the tip of these pegj tubes usually have some built-in extra weight (several grams), which theoretically should prevent slippage of the tube back into the stomach. however, these tubes usually cannot be placed very far into the duodenum and the build-in weight is usually not sufficient to keep the tube in place. the tip of the currently commercially available pegj tubes often (usually within 1-2 weeks) migrates back into the stomach and at that point the tube needs to be replaced. the investigational pegj feeding tube used in this study is self-propelled and has a balloon on its tip. the tip of this tube is directed endoscopically through the part of the stomach that connects to the duodenum (pylorus), then the balloon is filled with 5 cc of water and the endoscope is removed. the water filled balloon then is carried by the movement of the intestinal muscles through the duodenum into the middle section of the small intestine (jejunum). it is hoped that such a deep position of the tip of the self-propelled pegj tube and presence of the water-filled balloon on its tip will prevent migration of the tube back into the stomach and therefore eliminates the need for tube replacement. the only difference between the currently approved pegj feeding tube and the investigational one being used in this study is the addition of the balloon to the tip of the j port. people who come to johns hopkins hospital for pegj placement as part of standard clinical care and who are not pregnant may join the study.

Eligibility criteria:
inclusion criteria: * age 18-90 years * need for post-pyloric feeding (patients unable to eat due to stroke, intubated patients with respiratory failure, patients with acute pancreatitis, etc) * ability to give informed consent for the study exclusion criteria: * patients with uncorrectable bleeding disorders (inr more than 1.5, platelet count less than 50,000) * inability to get informed consent for the study from patients or their families * pregnancy (all women of child-bearing age will undergo urine pregnancy testing)

Keywords: pegj peg-j percutaneous endoscopic gastrostomy feeding tube gastroparesis acute pancreatitis stroke respiratory failure gerd balloon self-propelled
probiotic implementation as help in solving vaginal infections

Conditions: Vaginal Infection; ASC-US

Summary: over recent years, a growing interest has developed in microbiota and in the concept of maintaining a special balance between lactobacillus and other bacteria species in order to promote women's well-being. the aim of the study was to confirm that vaginal lactobacilli long-lasting implementation in women with hpvinfections and concomitant bacterial vaginosis or vaginitis might be able to help in solving the viral infection, by re-establishing the original eubiosis.

a total of 117 women affected by bacterial vaginosis or vaginitis with concomitant hpv infections were enrolled at department of gynecological obstetrics and urological sciences, la sapienza university, rome, italy between february 2015 and march 2016. women were randomized in two groups, standard treatment (metronidazole 500 mg twice a day for 7 days or fluconazole 150 mg orally once a day for 2 consecutive days) plus short-term (3 months) vaginal lactobacillus implementation (group 1, short probiotics treatment protocol group, n=60) versus the same standard treatment plus long-lasting (6 months) vaginal lactobacillus rhamnosus bmx 54 administration (group 2, treatment group, n=57).

Eligibility criteria:
inclusion criteria: * age\>18 years * documented bv or yeast vaginitis associated with hpv-infection documented as pap-smear abnormalities (ascus, l-sil or h-sil histologically demonstrated as cin1) and/or positive for hpv-dna exclusion criteria: * pregnancy or breastfeeding * previous abnormal pap-smear * cin2-3 * concomitant malignancies * immunological diseases * severe comorbidities * prolonged corticosteroid treatment.

Keywords: probiotics implementation hpv infection vaginosis yeast vaginitis
mechanisms of resistance to psma radioligand therapy

Conditions: Prostate Cancer

Summary: this is a multicenter, correlative study to existing lutetium based prostate-specific membrane antigen (psma)-targeted radioligand therapy (rlt) trials and uses.

primary objectives: i. to determine the relationship between whole body tumor absorbed dose and response lutetium based prostate-specific membrane antigen-targeted radioligand therapy (177lu-psma-rlt). ii. to determine the relationship between post-operative radiation therapy outcomes score (portos) score and response to 177lu-psma-rlt. iii. to determine the relative importance of radiation dose (whole body tumor absorbed dose) and radiation sensitivity (portos score) as a marker of response to 177lu-psma-rlt. exploratory objectives: i. to develop novel signature of radiation sensitivity. ii. to evaluate tumor biopsies to understand mechanisms of resistance. iii. to understand utility of post-cycle 4 single-photon emission computed tomography (spect/ct) to evaluate treatment response. study participants will undergo a biopsy and blood draw prior to the initiation of planned therapy, as well as spect/ct imaging performed after the first and fourth treatments. one spect/ct scan will be performed 24 (+/- 6) after the first treatment, and after the fourth treatment, a 24 +/- 6-hour post-treatment spect/ct will be performed. additionally, study participants may choose to undergo optional biopsy and blood draw at time of progression.

Eligibility criteria:
inclusion criteria: 1. initiating treatment with lutetium based psma-targeted rlt. 2. participants must have a psma-avid lesion that is accessible to biopsy. biopsy of newly emerging radiographic metastases is desired and preferable to the biopsy of previously existing lesions whenever possible. newly emerging lesions are defined as those that are absent on a previous scan, or those demonstrating unequivocal progression since initiation of the last treatment. biopsies will be performed according to local institutional standards. 3. patients on warfarin, aspirin, or other anti-coagulants are eligible provided they are deemed able to tolerate discontinuation of anti-coagulation for at least five days prior to the biopsy. conversion to low molecular weight heparin prior to biopsy is permitted per local standard operating procedures, provided there is approval by the interventional radiologist or the pi. 4. age \>=18 years. 5. ability to understand and the willingness to sign a written informed consent document. exclusion criteria: 1. patients with significant congenital or acquired bleeding disorders (eg von wildebrand's disease, acquired bleeding factor inhibitors). 2. patients who are not able to undergo additional study related imaging procedures.

Keywords: radioligand therapy
predictive value of myelodysplastic syndrome stem cells determined by multiparameter flow cytometry

Conditions: Myelodysplastic Syndromes

Summary: presently, multiparameter flow cytometry (mfc) and polymerase chain reaction (pcr) have been used for disease load, including measurable residual disease (mrd), monitoring in patients with myelodysplastic syndrome (mds). mfc is the most commonly method for disease load evaluation. in patients with acute myeloid leukemia, leukemia stem cells (lscs) determined using mfc for leukemia load and mrd detection is superior to traditional mfc method. in the investigators previous single center study, the investigators demonstrated that detection of disease load, including mrd, by mfc in patients with mds-eb is superior to predict outcomes after allogeneic stem cell transplantation. here, the investigators will perform a multi-center, prospective clinical trial to investigate the predictive values of mds-sc in patients with mds-eb who received allografting.


Eligibility criteria:
inclusion criteria: * patients with myelodysplastic syndromes; * between 15 and 70 years old; * subjects are able to provide written informed consent. exclusion criteria: * subjects who cannot comply with the study; * patient has severe cardiac (ejection fraction \ 34μmol/l, alt, ast \>2x upper limit of normal) or renal (blood creatinine \>130μmol/l) disease； * uncontrolled serious infection; * other conditions that do not tolerate transplantation or other therapies.