Kornimate/medical-research-clean huggingface dataset:
salvage mr-guided high-dose-rate brachytherapy for prostate bed recurrence after radiotherapy in the psma pet scan era

Conditions: Prostate Cancer Recurrent; Prostate Cancer

Summary: this is an interventional, single-centre, single-arm, non-randomized, prospective, feasibility trial investigating salvage mr-guided high-dose-rate brachytherapy for prostate bed recurrence after postoperative radiotherapy.

patients who received previous adjuvant or salvage radiotherapy to the prostate bed \> isolated prostate bed recurrence based on psma pet, biopsy-proven, and mr visible \> baseline: qols questionnaires, psa, pelvic magnetic resonance imaging (mri) scan for rt planning \> two fractions of 13 gy each delivered over 7-21 days. gtv(hdr) delineation (based on mri-guided and psma pet, biopsy data as applicable) \> follow-up after treatment 60 months: psa, ctcae v5.0, mri pelvis +/- psma-pet scan (optional at 24 months)

Eligibility criteria:
inclusion criteria: 1. patients who received previous rt to the prostate bed +/- pelvic nodal regions 2. prostate-bed recurrence identified by biopsy and/or mri and/or psma-pet scan 3. at least two continuous psa elevations post rt and psa above 0.2 ng/dl 4. with or without adt psa doubling time from nadir greater than 6 months 5. ecog 0-2 6. age greater than 18 years exclusion criteria: 1. radiological (e.g. psma pet, ct, mri or bone scan) evidence of or distant metastases 2. history of ≥g3 gastrointestinal (gi) and genitourinary (gu) toxicities following rt 3. any contraindications to mr and/or brachytherapy
study of a respiratory syncytial virus/human metapneumovirus/parainfluenza virus type 3 vaccine candidate in adults aged 60 years and older

Conditions: Respiratory Syncytial Virus Infection; Metapneumovirus Infection; Parainfluenzae Virus Infection

Summary: the purpose of this phase 1 study is to evaluate whether the vaccine is safe and can help the body to develop germ fighting agents called "antibodies" (immunogenicity) against the respiratory syncytial virus (rsv), human metapneumovirus (hmpv), and parainfluenza virus type 3 (piv3). the study will use different doses of piv3 only and different combinations of rsv/hmpv/piv3 or rsv/hmpv or only rsv vaccine in adults aged 60 years and older.

the study duration will be up to approximately 12 months minus the screening period.

Eligibility criteria:
inclusion criteria: * aged 60 years or older on the day of inclusion (means from the means from the day of the 60th birthday). * informed consent form (icf) has been signed and dated * a female participant is eligible to participate if she is of non-childbearing potential. to be considered of non-childbearing potential, a female must be postmenopausal for at least 1 year, or surgically sterile. exclusion criteria: participants are excluded from the study if any of the following criteria apply: -any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives. note: the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
mitochondrial dna in fresh versus frozen embryo culture media of pcos women undergoing in vitro fertilization

Conditions: Polycystic Ovary Syndrome; Assisted Reproduction

Summary: ninety women with pcos candidate for icsi were randomized to 2 groups:group a: fresh samples of pcos patients undergoing ivf (no= 45) and group b: frozen samples of pcos patients undergoing ivf (no= 45). morphologically good embryos will be cultured in a culture dish and the supernatants will be collected freshly from culture system at day 3 and stored at -20 ̊ c until being tested. morphologically good embryos scheduled for freezing will be cryopreserved for less than one year and thawed, the supernatant will be collected and stored at -20 ̊ c until being tested. quantification of mtdna in fresh and frozen culture media using qpcr technique.the template dna prepared and the dilution standards prepared will be used for qpcr to determine the amount of mtdna and nuclear dna in the sample using quantitect sybr green pcr kit

ninety women with pcos candidate for icsi were randomized to 2 groups:group a: fresh samples of pcos patients undergoing ivf (no= 45) and group b: frozen samples of pcos patients undergoing ivf (no= 45). morphologically good embryos will be cultured in a culture dish and the supernatants will be collected freshly from culture system at day 3 and stored at -20 ̊ c until being tested. morphologically good embryos scheduled for freezing will be cryopreserved for less than one year and thawed, the supernatant will be collected and stored at -20 ̊ c until being tested. quantification of mtdna in fresh and frozen culture media using qpcr technique.the template dna prepared and the dilution standards prepared will be used for qpcr to determine the amount of mtdna and nuclear dna in the sample using quantitect sybr green pcr kit (qiagen)

Eligibility criteria:
inclusion criteria: 1. age: 20-35 yrs. 2. bmi: ≤25. 3. pco: diagnosed by rotterdam criteria (at least two of the following): 1. polycystic ovary morphology with one ovary being sufficient for diagnosis. 2. hyperandrogenism: clinically or biochemically. 3. anovulation or oligo-ovulation. 4. gravidity and parity: nulligravida. 5. compliance: primary infertility exclusion criteria: * known medical problems as diabetes mellitus, hypertension, cardiac, hepatic or renal problem. * special habits of medical importance as smoking. * other endocrinopathies
study to evaluate efficacy and safety of wound dressing solution containing egf in patients with peptic ulcers bleeding

Conditions: Peptic Ulcer Bleeding

Summary: this is a prospective, single-blinded, randomized study to evaluate the efficacy and safety of cegp003 in patients with acute peptic ulcers bleeding, compared to endoscopic epinephrine injection therapy.

cegp003 is wound dressing solution containing hydroxyethyl-cellulose and egf. epidermal growth factor (egf) stimulates cell growth and differentiation by binding to its receptor, which can enhance wound healing and regeneration of new tissue, finally may provide a new option in treating a peptic ulcers bleeding.

Eligibility criteria:
inclusion criteria: * peptic ulcer with high-risk stigmata of recent hemorrhage (forrest class ia, ib, iia and iib) exclusion criteria: * subjects who have a history of malignant tumor in upper gastro-intestinal site * subjects with platelet and coagulation dysfunction (plt \ 2) * subjects that have taken anticoagulant drugs or non-steroidal anti-inflammatory drugs within 72 hours after the treatment * subjects with one or more bleeding sources * subjects who are pregnant or breast-feeding * subject who are allergic or have a hypersensitive reaction to hydroxyethyl-cellulose or egf * subjects who have undergone endoscopically therapies within the last 7 days * subjects who are considered not suitable for the study by significant disease * subjects who are not able to comply with the study requirements * subjects who are currently enrolled in another clinical study which can impact the study within 30 days of screening * subjects who are considered not suitable for the study by the investigator

Keywords: bleeding
acute coronary syndrome cardioflux tm study (accmed)

Conditions: Acute Myocardial Injuries

Summary: approximately 16.5 million people suffer from coronary artery disease (cad) and about 10 million present each year to emergency departments with symptoms like chest pain and shortness of breath, commonly suggestive of acute coronary syndrome (acs). to clinically assess acs risk in these patients, there are typically 2-6 hours of emergency room evaluation, followed by 6-42 hours of an observation period prior to discharge. the clinical pathway includes: 1) 1-3 ecg's; 2) serial troponins (1 and 3 hours vs 1 and 6 hours); and 3) other pertinent diagnostic information, including but not limited to echocardiography, stress testing and/or ct angiography. patients who are evaluated, have presented with a low risk for acs, and maintain negative diagnostic results can potentially be discharged within 6 hours. however, 20%-40% of patients who fall into indeterminate diagnostic categories will require longer observation periods or admission of 12-48 hours which result in the use of expensive imaging and provocative testing, such as stress testing. the purpose of accmed is to measure the efficacy of magnetocardiography (mcg) as a diagnostic tool to rule-in/rule-out myocardial ischemia in patients with suspicion of an acute coronary syndrome who have a heart score \> 2 and to allow safe and timely disposition of the patient to an appropriate level of care.


Eligibility criteria:
inclusion criteria: 1. ≥ 18 years of age at the time of enrollment. 2. patient presenting acutely with signs and symptoms suggestive of acs. 3. informed consent form signed by subject or lar. 4. heart score of \>2. 5. patient consented within 4 hours of the beginning of the clinical assessment (exclusive of any screening examination) for suspected acs by an appropriately credentialed clinician. exclusion criteria: 1. \< 18 years of age. 2. stemi. 3. unable to fit into device. 4. non-ambulatory patients. 5. positive response on mcg metal checklist. 6. deemed hemodynamically unstable by treating physician, regardless of cause. 7. unable to lie supine for up to 5 minutes. 8. poor candidate for follow-up (e.g., no access to phone). 9. prisoners. 10. repeat participants.

Keywords: ischemia cardiovascular disease mcg cardioflux
a double-blind, placebo-controlled trial of donepezil adjunctive treatment for cognitive impairment in schizophrenia

Conditions: Impaired Cognition; Schizophrenia

Summary: the objective of the study was to study the effects of donepezil on cognition in patients with schizophrenia. the investigators conducted a 12-week, double-blind, placebo-controlled trial of donepezil as adjunctive treatment to antipsychotic drugs on patients with schizophrenia.

the investigators conducted a 12-week, double-blind, placebo-controlled trial of donepezil as adjunctive treatment to antipsychotic drugs on patients with schizophrenia.the trial will be complete in 2012.

Eligibility criteria:
inclusion criteria: * dsm-iv diagnosis of schizophrenia as determined by the structured clinical interview for dsm-iv axis i disorders-clinician version; * between 18 and 40 years of age; * duration of the illness must be longer than 2 year; * patient's current antipsychotic medication regimen must be stable; * must be in a stable living arrangement; exclusion criteria: * patient has mental retardation or severe organic brain syndromes; * treatment with electroconvulsive therapy (ect) within 6 months prior to screening; * has suicidal attempts or ideation or violent behavior within the last 12 months; * patient has a history of alcohol/drug dependence;

Keywords: impaired cognition schizophrenia
pimavanserin for sleep in parkinson disease

Conditions: Parkinson Disease

Summary: this pilot, self-control study is for patients with parkinson's disease (pd) psychosis (e.g., visual hallucinations, delusions) and sleep problems.

this is a feasibility study to determine whether pimavanserin improves sleep quality in patients with pd and visual hallucinations/delusions. patients will complete a screening visit to assess eligibility to participate in the study. for more information, please contact sofya glazman, a study coordinator, at sofya.glazman@downstate.edu

Eligibility criteria:
inclusion criteria: 1. has a diagnosis of idiopathic pd according to uk (united kingdom) pd society brain bank diagnostic criteria 2. has a history of hallucinations or delusions associated with pd 3. has a history of sleep disturbance 4. is between the ages of 40 and 85 5. has been on a stable dose of all pd medications for at least 30 days prior to enrolment exclusion criteria 1. has evidence of an atypical or secondary parkinsonian disorder 2. has a contraindication to taking pimavanserin 3. has contraindication to psg 4. there has been a change to patient's neuropsychiatric medications including dopaminergic medications (sinemet, dopamine agonists, mao(monoamine oxidaze)-b inhibitors), ssris (selective serotonin reuptake inhibitors), snris (serotonin and norepinephrine reuptake inhibitors), dopamine-blocking agents, anti-epileptics, anticholinergics, or benzodiazepines for at least 30 days prior to enrollment 5. has traveled through 3 or more time zones within 60 days prior to study screening 6. patient is a night-shift worker

Keywords: sleep visual hallucinations delusions
vitamin d supplementation in ckd - vascular function, structure and immune regulation

Conditions: Atherosclerosis; Chronic Kidney Disease

Summary: a pilot study to assess feasibility of methods of an observer-blinded randomised controlled trial of the effect of vitamin d supplementation in chronic kidney disease and low vitamin d levels on markers of vascular function (flow mediated dilatation of brachial artery), vascular structure (carotid intima media thickness) and immune regulation (frequencies of cd4+cd28null t lymphocytes ad regulatory t lymphocytes).

the study is a single (observer) blinded feasibility pilot randomised study. study subjects will be recruited from clinics run by st george's hospital renal department and randomised to treatment arm or no treatment arm. in treatment arm, six doses of vitamin d tablets (cholecalciferol 100,000 iu, five capsules total) will be administered on weeks 0, 4, 8, 12, 16 and 20. in the no-treatment arm the participants receive no cholecalciferol. participants will have serum calcium levels measured at week 12. all participants will undergo estimation of endothelial function, carotid intima-media thickness, cd4+cd28null and regulatory t cell frequency in week 0 and week 26. the observer will be blinded to whether the patient is in the treatment or no-treatment arm whilst the following tests are performed: 1. measurement of brachial artery flow mediated dilatation 2. measurement of carotid intima media thickness 3. quantification of cd4+cd28null and regulatory t cell frequency the pilot study will assess feasibility of the study methods.

Eligibility criteria:
inclusion criteria: 1. age 18-80 years 2. calcium \< 2.58mmol/l 3. on an ace inhibitor/arb 4. vitamin d \<75nmol/l 5. egfr 15- 60ml/min/1.73m2 and stable 6. informed consent to participate exclusion criteria: 1. patients already on vitamin d or calcium supplementation 2. patients with known malignancies 3. patients with autoimmune conditions 4. patients with heart failure (ejection fraction \ 500pg/ml) 5. patients with active infection 6. rapidly deteriorating renal function 7. recent acute coronary syndrome or cerebro-vascular event (within the last 6 months) 8. uncontrolled hypertension (bp\>160 systolic)

Keywords: vitamin d cholecalciferol chronic kidney disease cardiovascular disease atherosclerosis flow mediated dilatation carotid intima media thickness cd4+cd28null t lymphocyte regulatory t lymphocyte
comparation between two surgical techniques with acellular dermal matrix in treatment of gingival recessions

Conditions: Gingival Recession; Gingival Diseases; Mouth Diseases; Periodontal Atrophy; Periodontal Diseases; Stomatognathic Diseases

Summary: the gold standard for the treatment of gingival recession, is the coronal repositioning of the flap associated with the subepithelial connective tissue graft. the acellular dermal matrix (adm) has been used as a substitute a subepithelial connective tissue graft in periodontal plastic surgery and mucogengivais, and has achieved similar results. the use of adm has the advantage of avoiding possible pre and postoperative complications, as well as overcome the limitations presented by autograft. the different surgical techniques used for root coverage seek predictability and success. for this, besides the type of incision placements flap and graft are of utmost importance because the healing benefit and outcome. the aim of this study is to compare two surgical techniques for root coverage and evaluate which one provides better cosmetic results and less morbidity . 20 adults , nonsmoking patients , showing multiple bilateral gingival recessions , class i or ii miller located in canine, first and second premolars are selected. both techniques use the adm as a graft. however , in one quadrant partial flap will be held together with relaxing incisions through an incision intrasucular , adm will be positioned 1 mm apical to the cementoenamel junction (cej) and the flap will be positioned 1 mm coronal cej. in the opposite quadrant a minimally invasive technique periosteal envelope above does not use relaxing incisions , preserves the buds will be held , as well as avoiding any scars, the graft will be used to adm. the clinical parameters (probing depth, clinical attachment level, bleeding on probing index, height and width of the gingival retraction and height and thickness of keratinized gingiva) will be evaluated 2 weeks after the basic periodontal therapy and after 6 and 12 months to surgical procedures. in addition, measurements of photographic gingival recession with the aid of software will be performed.


Eligibility criteria:
inclusion criteria: ages 18 to 50 years old bilateral multiple gingival recession type miller class i or ii with at least one tooth with 3 mm in height and less than 3mm of keratinized tissue in canine and pre-molar teeth exclusion criteria: diabetics pregnant women chronic use of medication periodontitis smokings

Keywords: root coverage gingival recession periodontal surgery
efficacy and safety of a food supplement with standardized menthol, limonene, and gingerol content in patients with irritable bowel syndrome

Conditions: Irritable Bowel Syndrome; Irritable Bowel Syndrome With Diarrhea; Irritable Bowel Syndrome With Constipation; Irritable Bowel Syndrome Mixed

Summary: the purpose of this study is to assess the efficacy and safety of a food supplement with standardized menthol, limonene, and gingerol content in patients with irritable bowel syndrome (ibs) or ibs/functional dyspepsia (fd).

using a random number generator, 56 patients meeting inclusion criteria with ibs or ibs/fd were randomly assigned to either the intervention group (28 individuals) or the control group (28 individuals) (table 2). non-functional causes for the symptoms were excluded by a detailed evaluation of the medical history, physical examination, extensive panel of blood tests, stool analysis, and colonoscopy with biopsies. diarrhoea-predominant ibs patients (ibs-d) and mixed bowel habits ibs patients (ibs-m) were treated with smooth muscle antispasmodics. the constipation-predominant ibs patients (ibs-c) were treated with smooth muscle antispasmodics and laxatives. ibs/fd patients were treated with smooth muscle antispasmodics and proton pump inhibitors. at visit 1, all patients were randomly assigned into two groups. in the intervention group (group 1), the supplement "standart zdorovya gastro" (1 capsule, 730 mg, once a day) was added to the standard treatment regimen for 30 days. in the control group (group 2), placebo (1 capsule, 730 mg, once a day) was added to the standard treatment regimen for 30 days (table 1). researchers and patients were not informed who received a supplement or placebo. during the 30 days of the study, three outpatient visits were conducted (visit 1 - day 1, visit 2 - day 15 + 2 days, and visit 3 - day 30 + 2 days). symptom severity was assessed on each visit using "7x7" questionnaire \[ivashkin, v., sheptulin, a., shifrin, o., poluektova, e., pavlov, c., ivashkin, k., drozdova, a., lyashenko, o., korolev, a., 2019. clinical validation of the "7 × 7" questionnaire for patients with functional gastrointestinal disorders. j. gastroenterol. hepatol. 34, 1042-1048. https://doi.org/10.1111/jgh.14546\], on 1 and 3 visits stool samples were collected for the qualitative and quantitative composition of the intestinal microbiota based on 16s rrna gene sequencing. the study protocol was approved by the ethics committee of the mental health research center, moscow, russian federation (no. 418 dated 01/31/2018) and written informed consent was obtained from all participants.

Eligibility criteria:
inclusion criteria: * irritable bowel syndrome (ibs) * diarrhea-predominant ibs * constipation-predominant ibs * mixed-type ibs * ibs/functional dyspepsia symptoms * must be able to swallow tablets exclusion criteria: * organic bowel disease * renal disease * hepatic insufficiency, * schizophrenia * bipolar disorder * epilepsy

Keywords: functional dyspepsia
the effect of reiki in patients with type-ii diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: aim: to evaluate the effects of reiki on subjective well-being, happiness, and some metabolic variables in patients with type-ii diabetes.

this study, designed as a randomized controlled trial with a pretest-posttest design, was conducted between september 2022 and august 2023 at the internal medicine clinic of kanuni sultan süleyman training and research hospital, istanbul provincial health directorate. the participants were voluntary individuals who had been diagnosed with type-ii diabetes mellitus at least 6 months prior, had a bmi ≥ 25kg/m² (overweight or obese), hba1c ≥ 6.5%, were following a diabetes-specific diet or using oral antidiabetics, and were neither reiki practitioners nor instructors. randomization was used to assign participants to either the reiki group or the control group. during the pretest, participants were asked to complete the personal information form, the subjective well-being scale (sws), and the oxford happiness scale (ohs). pre-intervention fasting and postprandial blood glucose levels, hba1c percentage, body mass index, ldl-hdl/total cholesterol, triglyceride levels, and blood pressure measurements were obtained from the patients' records and documented.the reiki group received 20 minutes of remote reiki once a day for 4 consecutive days, while no intervention was applied to the control group. the subjective well-being scale and oxford happiness scale were reapplied to both groups at the first and second months following the intervention, and the metabolic values, along with these scales, were measured again in the third month.

Eligibility criteria:
inclusion criteria: * diagnosed with type-ii diabetes mellitus at least 6 months prior * had a bmi ≥ 25kg/m² (overweight or obese) * hba1c ≥ 6.5% exclusion criteria: * being diagnosed with another disease and needing treatment during the data collection process * being a reiki practitioner or instructor * using insulin for treatment

Keywords: diabetes mellitus reiki well-being happiness metabolic control