Kornimate/medical-research-clean huggingface dataset:
piloting a patient-reported outcome measure for opioid use disorder recovery in a clinical setting

Conditions: Substance Use Disorders; Opioid Use Disorder

Summary: performance measure can improve quality of care at the patient, provider, and systems level of care, and patient-reported outcome measures bring a needed patient-centered focus. recovery has been difficult to measure for people with substance use disorders, and is more challenging in the context of opioid use disorders (oud) and treatment medications. this study will examine a recovery patient-reported outcome measure to determine if patients and clinicians find it useful and acceptable in the clinical context, and if it leads to improved outcomes.

the pilot clinical trial will test the newly developed recovery patient-reported outcome measure ("recovery prom") and approach with patients and clinicians in an office-based opioid medication treatment program (known as office-based opioid treatment (obot), medication-assisted treatment (mat) or medications for oud (moud)), in the specific context of buprenorphine treatment. aims this is a pilot study to assess the feasibility of implementing the recovery prom into the workflow of a clinical setting, assess its initial effectiveness, and evaluate its value to patients and clinicians. the aims are as follows: 1. work with a clinical partner to assess and refine the draft recovery prom, and examine feasibility and implementation (e.g., workflow, data transfer issues) related to its use in a clinical setting. 2. determine initial effectiveness of the recovery prom for improving patient outcomes (self-efficacy, health-related quality of life, patient-provider relationship, social determinants of health, substance use) and facilitating self-directed care and patient-centered shared decision-making. 3. evaluate and update (if needed) the recovery prom in terms of recovery while on oud medication treatment, patient characteristics, and clinical workflow. hypotheses although this pilot study is primarily for information gathering, and ultimately refinement of the recovery prom and approach, the study has two broad hypotheses. h1. patients and clinicians will find the recovery prom to be a useful tool for patient recovery. h2. patient self-efficacy, shared decision-making, patient-provider relationship, and health-related quality of life will improve and substance use will decrease with the use of the recovery prom.

Eligibility criteria:
inclusion criteria: patients: * taking buprenorphine for oud treatment, in current episode of care at clinical partner site, for at least 6 weeks but less than 3 years. * able and willing to provide informed consent. * able to read english, to provide informed consent and complete study instruments. * able to use a smart phone to complete study instruments \[phones with data plan will be provided for those without\]. exclusion criteria: • patients who do not meet inclusion criteria.

Keywords: patient reported outcome measure recovery measure development
effect of different ventilation modes on pocd in elderly patients with abdominal wall hernia

Conditions: Postoperative Cognitive Impairment; Optic Nerve Sheath Edema

Summary: the purpose of this clinical trial is to understand the effect of different ventilation patterns during surgery on postoperative cognitive impairment in elderly patients with abdominal wall hernias. it will also explore how to reduce the incidence of postoperative cognitive impairment. the main questions it aims to answer are: * does the mode of ventilation affect the incidence of postoperative cognitive impairment in elderly patients? * does optic nerve sheath edema affect the incidence of postoperative cognitive impairment in elderly patients? researchers will monitor patients with different ventilation patterns intraoperatively and investigate postoperatively to see if the ventilation pattern affects postoperative cognitive impairment. participants will: * randomly assigned to groups with different ventilation patterns * record various values during surgery by the researchers * presence of cognitive impairment assessed by cognitive scales after surgery


Eligibility criteria:
inclusion criteria: * age: 65-90 years * patients with abdominal wall hernias * american society of anesthesiologists general status (asa-ps) classes ii and iii. exclusion criteria: * emergency (rather than elective) surgery or other types of surgery required * more than one surgery required during hospitalization * preoperative demonstrated inability to communicate (due to coma, severe dementia, parkinson's disease, severe hearing or visual impairment, or speech impairment).

Keywords: ventilation patterns elderly patients abdominal wall hernia postoperative cognitive impairment
prospective physician-initiated observational study of the contact detection system (cds) in patients undergoing radiofrequency ablation using the niobe™ remote magnetic navigation system

Conditions: Atrial Fibrillation; Catheter Ablation

Summary: this observational study evaluates peri-procedural results of the niobe™ remote magnetic navigation (rmn) es system using the contact detection system (cds) in patients undergoing standard of care radiofrequency ablation of cardiac arrhythmias. the objective of this observational study is to confirm system performance of the cds and that it does not alter pacing, electrocardiograms, or mapping during rf ablation procedures.


Eligibility criteria:
inclusion criteria: * patients with a clinical indication for rf ablation of cardiac arrhythmias with the niobe remote magnetic navigation system * patients referred to one of the participating ablation centers * written informed consent exclusion criteria: * presence of a atrial thrombus or left atrial appendage (laa) thrombus seen on (contrast) echocardiography or mri * contra-indication for general anesthesia * age below 18 years

Keywords: atrial fibrillation atrial arrhythmia arrhythmias, cardiac cardiac diseases electrophysiologic techniques, cardiac electrophysiology remote magnetic navigation contact detection system
trial and follow-up of the efficacy of two-stage integrated treatment for chinese schizophrenia inpatients

Conditions: Schizophrenia

Summary: regular psychosocial intervention combined with antipsychotic drugs, compared with usual medication alone treatments, can reduce psychiatric symptoms and improve quality of life in patients with schizophrenia. however, it's expensive, time-consuming, and sometimes inconvenient for patients and their family members in developing areas where the number of well-trained therapist remains limited in local psychiatric settings. the investigators aimed to establish an efficient model of integrated treatment (it) for patients with schizophrenia. the procedure contains two stages: a centralized treatment during hospitalization and the following consolidation treatments with long intervals.


Eligibility criteria:
inclusion criteria: * diagnosed with the structured clinical interview for dsm-iv (scid-dsm-iv) (first et al., 1996), were recruited from inpatient psychiatric ward. patients with diagnoses of schizoaffective or other psychotic disorders were not included. * additional inclusion criteria for participants were aged between 18 and 50 years with education of more than 9 years, and * panss (positive and negative syndrome scale) total scores of more than 60. exclusion criteria: * diagnosed with a serious and unstable medical condition including abuse and/or dependence of alcohol and/or drugs; * pregnant or breastfeeding; * under a treatment of clozapine with a dose of more than 200 mg/day, * had a treatment of the electroconvulsive therapy (ect) or modified electroconvulsive therapy within 6 months(mect) within the past six months.
long-term extension study of intepirdine (rvt-101) in subjects with dementia with lewy bodies: headway-dlb extension

Conditions: Dementia With Lewy Bodies

Summary: this 6-month extension study will provide further information regarding the long-term safety and tolerability of intepirdine (rvt-101) in subjects with dementia with lewy bodies (dlb) who have participated in the double-blind, placebo-controlled, lead-in study rvt-101-2001.

this 6-month, double-blind,extension study will provide further information regarding the long-term safety and tolerability of intepirdine (rvt-101) in subjects with dlb who have participated in the double-blind, placebo-controlled, lead-in study rvt-101-2001. the study duration for subjects in study centers in the usa will be 12 months. subjects who were randomized to the rvt-101 35-mg and rvt-101 70-mg treatment groups in lead-in study rvt-101-2001 will remain in the same treatment groups for this study; subjects who were randomized to the placebo treatment group in the lead-in study will be assigned to the rvt-101 70-mg treatment group in this study. various background therapies, including acetylcholinesterase inhibitors and memantine, will be allowed.

Eligibility criteria:
inclusion criteria: * participated in the lead-in study rvt-101-2001. exclusion criteria: * any clinically relevant concomitant disease, which, in the opinion of the investigator, makes the subject unsuitable for inclusion in the study.

Keywords: dementia with lewy bodies dementia rvt-101 intepirdine lewy bodies
hansenula-derived pegylated interferon in treatment of patients with chronic hepatitis c

Conditions: Chronic Hepatitis C

Summary: it is a multi-center study of the efficacy of a new pegylated hansenula-derived recombinant interferon α 2a (reiferon retard® 160 µg once weekly in combination with ribavirin in treatment of egyptian patients with chronic hepatitis c for 48 weeks. hepatitis c virus (hcv) viral load will be assessed during therapy at weeks 12, 24 and end of treatment, as well as 24 weeks after therapy is completed.

multicenter , phase iv, open labeled, non-randomized trial to assess the efficacy of hansenula-derived recombinant pegylated interferon α 2a (reiferon retard® in treatment of naïve chronic hepatitis c virus egyptian patients. each participant will be subject to thorough history taking, complete clinical examination, biochemical laboratory and hematological tests, u/s imaging as well as histologic assessment of liver disease stage and severity to ensure his/her eligibility to be enrolled in the study according to predetermined inclusion and exclusion criteria . eligible subjects will be treated with reiferon retard® 160 µg once weekly by subcutaneous injection for 48 weeks treatment plus weight-based ribavirin orally (1200 mg/kg daily for those \> 75 kg or 1000mg/kg daily for those ≤ 75 kg in divided doses). hcv rna will be assessed at week 12 of initiation of therapy to identify early virologic response (evr), at week 24 to identify breakthrough viremia, at week 48 to identify end of treatment response (etr), and at week 72 to identify sustained virologic response (svr). all subjects will be followed up during the study as described in the table below (section 4 study design).

Eligibility criteria:
inclusion criteria: 1. age \> 18 and \< 60. 2. bmi ≤ 30 3. liver biopsy showing chronic hepatitis with significant fibrosis (f2 and f3 using metavir scoring system) regardless of aminotransferase elevations. 4. f1 stage (by metavir scoring system) with elevated aminotransferases. 5. compensated liver disease; serum bilirubin \< 1.5 mg/dl, inr no more than 1.5, serum albumin ≥ 3.5 g/dl, platelet count ≥ 1000 cmm, and no evidence of hepatic decompensation (hepatic encephalopathy or ascites). 6. acceptable hematological and biochemical indices (hemoglobin ≥ 11g/dl; total leukocytic count ≥ 3000/cmm, absolute neutrophil count ≥ 1500/cmm and serum creatinine \< 1.97 mg/dl. 7. willing to be treated and to adhere to treatment requirements. exclusion criteria: 1. major uncontrolled depressive illness. 2. solid organ transplantation. 3. autoimmune conditions, known to be exacerbated by peginterferon and ribavirin. 4. untreated thyroid disease. 5. pregnant or unwilling to comply with adequate contraception. 6. severe concurrent medical disease, such as severe hypertension, heart failure, significant coronary artery disease, poorly controlled diabetes (hba1c \> 8.5 %), and chronic obstructive pulmonary disease. 7. known hypersensitivity to drugs used to treat hcv.

Keywords: chronic hepatitis c egyptian patients pegylated interferon ribavirin reiferon retard
laser-mediated photodynamic therapy of acne vulgaris and rosacea

Conditions: Acne Vulgaris and Rosacea

Summary: to evaluate efficacy and adverse effect from long-pulsed dye laser versus long-pulsed dye laser-mediated photodynamic therapy for acne vulgaris and rosacea.


Eligibility criteria:
inclusion criteria: * inflammatory acne and rosacea * skin types i-iv exclusion criteria: * patients younger than 18 years * skin types v and vi * topical and systemic conventional acne treatments
the effect of dose titration and dose tapering on the tolerability of dvs sr in women with vasomotor symptoms

Conditions: Vasomotor Symptoms

Summary: desvenlafaxine succinate (dvs sr) is a serotonin and norepinephrine reuptake inhibitor (snri). it is a nonhormonal option for the treatment of vasomotor symptoms (vms) associated with menopause. nausea is the most common adverse event that is observed in clinical studies and is the main reason for discontinuation during the first week of therapy. other adverse events (headache, nausea, and dizziness) associated with dvs sr have been noted to occur when subjects abruptly discontinue the medication. the purpose of this study is to evaluate several titration and tapering regimens of dvs sr to ensure a better tolerability profile at the start and completion of treatment. in addition, this study will provide a long posttreatment follow-up to assess any symptoms after treatment is discontinued.


Eligibility criteria:
inclusion criteria: * generally healthy, postmenopausal woman who seeks treatment for hot flushes. * meets 1 of the following: at least 12 months of spontaneous amenorrhea; at least 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone (fsh) levels \> 40 miu/ml; at least 6 weeks postsurgical bilateral oophorectomy (with or without hysterectomy). hysterectomized without bilateral oophorectomy and with serum fsh levels \>40 miu/ml. exclusion criteria: * history of a seizure disorder other than a single childhood febrile seizure. * history or presence of clinically important hepatic or renal disease or other medical disease. * presence or recent history of major depressive disorder, bipolar disorder, psychotic disorder, or generalized anxiety disorder requiring therapy.
biomarker changes and anxiolytic effects-phase 2

Conditions: Pharmacokinetics

Summary: this study will examine the utility of plasma and urinary based biomarkers for the anxiolytic properties of kava. the investigators will conduct a one week, double blind, randomized placebo controlled trial of kava, dosed at three 75 mg capsules per day, vs placebo, in adults with generalized anxiety disorder.

this study will examine the utility of plasma and urinary based biomarkers for the anxiolytic properties of kava, a natural dietary supplement. the investigators will conduct a one week, double blind, randomized placebo controlled trial of kava, dosed at three 75 mg capsules per day, vs placebo, in adults with generalized anxiety disorder. clinical measures of anxiety, blood, and urine will be obtained. biomarkers of interest include prkaca, cortisol, urinary tce, and na5ht. participants will be assessed pre- and post-treatment. the participants will also be followed for 12 weeks after the end of treatment to identify any potential rare adverse events, particularly liver toxicity, that appear in a delayed fashion.

Eligibility criteria:
inclusion criteria: * adults ages 18-50 who meet diagnostic statistical manual (dsm)-5 criteria for gad as the primary psychiatric diagnosis * no more than one failed therapeutic trial of an fda approved medication for the treatment of gad * score of\>14 on the hamilton anxiety rating scale at both screening and baseline * at least a 4 (moderate) on the clinical global impressions severity scale at both screening and baseline * females of potential childbearing status must use adequate contraceptive precautions. exclusion criteria: * unwilling/unable/unsafe to stop psychotropic medications (if on any) for the duration of the study * inability to refrain from acetaminophen, alcohol or other potentially hepatotoxic substances * history of liver disease or current liver disease or clinically significant elevation in serum liver chemistries * unstable medical or neurological condition * positive urine drug screen for substances of abuse * active substance abuse/dependence * lifetime history of a psychotic disorder, bipolar disorder, ptsd or obsessive compulsive disorder * any significant risk for self-harm or suicidality as determined by the principal investigator or suicide attempt within the last 6 months * psychotherapy newly instituted during the 6 weeks leading up to enrollment in the study. subjects established in psychotherapy without change during the course of the study may participate * montgomery-asberg depression rating scale (madrs) \> 17 (moderate or severe depressive symptoms)

Keywords: kava dietary supplement anxiety generalized anxiety disorder (gad)
proton therapy for lymph nodes in breast cancer

Conditions: Breast Cancer

Summary: the purpose of this study is to determine if proton radiation therapy will reduce the amount of heart that is exposed to radiation, thereby decreasing the frequency and/or severity of any cardiac side effects.


Eligibility criteria:
inclusion criteria: * pathologically confirmed invasive adenocarcinoma of the breast stage i-iii (tx, t0-4, n0-3) with medially located tumor and/or axillary node invasion. * patients must have undergone either mastectomy or breast conservation surgery. * patients are required to have axillary staging which can include sentinel node biopsy alone if sentinel node is negative. * patient must require peripheral lymph node radiation per physician discretion. exclusion criteria: * evidence of distant metastasis (m1). * prior radiotherapy to the area of interest. * prior history of cardiovascular disease per physician discretion. * prior or concurrent cancer other than non-melanomatous skin cancer unless disease free for at least 5 years. * collagen vascular disease, specifically dermatomyositis with a cpk level above normal or with an active skin rash, systemic lupus erythematosis or scleroderma.

Keywords: proton radiation breast cancer
rotator cuff tears treated with long head of the biceps reinforcement

Conditions: Rotator Cuff Injuries; Biceps Tendon Reattachment

Summary: the increase of the population life expectancy and the active lifestyle adopted in recent years have contributed to the higher incidence of rotator cuff injuries. for large (\>3 cm) and extensive (\>5 cm) injuries of the rotator cuff, even after complete or partial repair, the chances of failure reach 94%. an alternative in rotator cuff injuries is the use of the long head of the biceps (lhb) as an autologous graft to increase the healing rate and the final outcomes. the primary objective is to compare the functional results, according to the ases score, between patients who use or not the long head biceps brace for complete repairs of large and extensive rotator cuff tears. the secondary objectives are to compare the groups according to structural results by mri and functional results by the ucla score.

a prospective randomized study will be carried out in a 1:1 ratio between groups. patients with large and extensive rotator cuff injuries will be selected at the shoulder and elbow clinic of pedro ernesto university hospital (hupe-uerj), during outpatient care. patients with an intact long head of the biceps will be randomized into two groups, according to the use or not of the tendon: complete repair with lhb tendon reinforcement and complete repair without reinforcement. all patients will be operated by the same surgeon. all selected patients will be explained what the research is about by a research assistant not involved in the treatment and will be offered the option to participate or not. the "american shoulder and elbow surgeons standardized shoulder assessment form" (ases) scale will be adopted as the primary outcome. the "modified university of california at los angeles shoulder rating scale" (ucla) and the assessment of tendon healing with magnetic resonance imaging at 6 months after surgery, using the classification of sugaya et al. will be secondary outcomes.

Eligibility criteria:
inclusion criteria: * long head tendon of biceps intact; * large or extensive posterosuperior rotator cuff injuries according to the classification of deorio and cofield;20 * fatty degeneration of the ≦2 supraspinatus muscle according to the classification of goutallier.21 exclusion criteria: * active or previous infection in the affected shoulder; * patients unable to understand preoperative questionnaires; * patient who does not undergo at least 1 postoperative evaluation. * injury where complete repair of the rotator cuff is not possible; * rupture of the lhb tendon diagnosed intraoperatively.

Keywords: rotator cuff tendon transfer biceps reinforcement biceps autograft
long covid (individuals with ongoing covid-19 symptoms) ongoing effects

Conditions: COVID-19 Infection

Summary: persistent covid-19 symptoms, known as long covid, can impact healthcare provision. this study aimed to assess how symptoms persisting six months after covid-19 affect quality of life and functional capacity.


Eligibility criteria:
inclusion criteria: * the study included individuals who had covid-19 disease at least 6-18 months ago, who agreed to participate, and who were diagnosed with covid-19 by a health institu-tion during the disease period. exclusion criteria: * individuals who were not between the ages of 18-65, who had cognitive and commu-nicative impairments, and who had orthopedic and neurological limitations that would prevent them from performing physical activity were excluded from the study.

Keywords: long covid quality of life covid-19
protective antibody level after covid-19 vaccination among patients under hemodialysis

Conditions: Covid19; Vaccine Reaction; Hemolysis; End-stage Renal Disease

Summary: the aim of the study is to evaluate the level of neutralizing antibody against sars-cov-2 after covid-19 vaccination in patients under hemodialysis. to this end, the level of neutralizing antibody of patients under hemodialysis is compared to that of healthy population.


Eligibility criteria:
inclusion criteria: * the person who is vaccinated with chadox1 (covid-19 vaccine) * the person who agrees with the protocol of the study exclusion criteria: * age \< 18 years * pregnants * experience of covid-19 infection