Kornimate/medical-research-clean huggingface dataset:
effect of emdr in the treatment of fibromyalgia

Conditions: Fibromyalgia

Summary: the goal of this randomized-controlled study is to investigate the impact of emdr therapy on fibromyalgia symptoms, depression, sleep quality, and traumatic stress in fibromyalgia patients. the main questions it aims to answer are: * does emdr become useful in relieving pain and complaints in fibromyalgia patients? * is specific emdr fibromyalgia protocol effective of fibromyalgia patients? * does emdr therapy decrease depression, sleep quality and traumatic stress symptoms of individuals with fibromyalgia?

background: in addition to pharmacological treatments, psychotherapeutic approaches are recommended for the treatment of fibromyalgia. there is a suggestion that eye movement desensitization and reprocessing (emdr) therapy may be effective. this study aims to investigate the impact of emdr therapy on fibromyalgia symptoms, depression, sleep quality, and traumatic stress in fibromyalgia patients through a randomized controlled study (rct). material and methods: the sample for this study comprises 79 individuals diagnosed with fibromyalgia. participants were randomly assigned to two groups: the 'treatment as usual' (tau) group and the tau+emdr group. prior to the study and at six different time points (before starting the study, at the end of the 5th, 10th, and 15th sessions, 1 month later, and 3 months later), participants completed assessments, including the fibromyalgia impact questionnaire (fiq), visual analog scale (vas), fibromyalgia acr 2010 diagnostic criteria (widespread pain index (wpi) and symptom severity scale (sss)), beck depression inventory (bdi), pittsburgh sleep quality index (psqi), and trauma symptom checklist-40 (tsc-40).

Eligibility criteria:
inclusion criteria: 1. diagnosis of fibromyalgia, 2. age between 18-65, 3. compliance with routine medical fibromyalgia treatment, 4. cognitive and technical competence to meet the working conditions, 5. volunteering to participate in the study. exclusion criteria: 1. receiving any psychotherapy, 2. presence of psychiatric disorders such as schizophrenia or bipolar affective disorder, c) no other physical and psychological targets apart from trauma needing to be addressed before fibromyalgia pain (e.g., suicide, domestic violence, etc.), d) presence of an organic cause that can cause pain.

Keywords: emdr rct depression pain
a study of pegasys (peginterferon alfa-2a (40kd)) in combination with copegus (ribavirin) in patients with chronic hepatitis c (chc) enrolled in a methadone maintenance treatment program.

Conditions: Hepatitis C, Chronic

Summary: this study will evaluate the safety and tolerability of pegasys plus ribavirin in previous intravenous (iv) drug users who have chc and are currently enrolled in a methadone maintenance treatment program. the anticipated time on study treatment is 1-2 years, and the target sample size is \<100 individuals.


Eligibility criteria:
inclusion criteria: * adult patients at least 18 years of age * chc infection, genotype 1, 2, or 3 * naive to treatment for chc infection * enrolled in a methadone maintenance program with documented attendance for at least 3 months * use of 2 forms of contraception during the study on both men and women exclusion criteria: * previous treatment for chc infection * co-infection with human immunodeficiency virus (hiv) * current use of iv or other illicit drugs * decompensated cirrhosis * women who are pregnant or breastfeeding
prospective study of teclistamab in the treatment of systemic al amyloidosis

Conditions: AL Amyloidosis

Summary: this study aims to evaluate the use of teclistamab in systemic al amyloidosis and answer whether teclistamab can improve the rate of complete hematological response. this is a single-arm, multi-center, prospective study. participants will receive the single drug teclistamab, which the investigator deems the best choice.

the treatment of amyloidosis should focus more on complete hematological response (chr) and organ response rate. we hypothesize that teclistamab can deeply eliminate cloned plasma cells in al patients, achieving a high proportion of complete hematological response. in clinical practice, if daratumumab, bortezomib, and venetoclax (for patients with t(11;14)）have been used, the outcome is poor. also, chr is correlated with better clinical outcomes. in clinical routine practice, we use teclistamab, a more effective treatment to eliminate clonal plasma cells. to further explore efficacy and safety, we designed this prospective study.

Eligibility criteria:
inclusion criteria: 1. diagnosis of systemic al amyloidosis; 2. patients must have received standard-of-care daratumumab, bortezomib, they do not have at least one organ response, and have not get complete hematological response; 3. life expectancy greater than 12 weeks; 4. hgb ≥70g/l; 5. blood oxygen saturation \> 90%; 6. total bilirubin (tbil) ≤3×upper limit of normal (uln); aspartate aminotransferase (ast) and alanine aminotransferase (alt) ≤3.0×uln; 7. informed consent explained to, understood by and signed by the patient. exclusion criteria: 1. fulfill with the criteria of active multiple myeloma or active lymphoplasmacytic lymphoma. 2. presence of other tumors which is/are in advanced malignant stage and has/have systemic metastasis; 3. severe or persistent infection that cannot be effectively controlled; 4. presence of severe autoimmune diseases or immunodeficiency disease; 5. patients with active hepatitis b or hepatitis c (\[hbvdna+\] or \[hcvrna+\]); 6. patients with hiv infection or syphilis infection; 7. any situations that the researchers believe will increase the risks for the subject or affect the results of the study.

Keywords: teclistamab complete hematological response
effectiveness of probiotic supplement in improving attention deficit hyperactivity disorder symptoms

Conditions: Attention Deficit Hyperactivity Disorder

Summary: to study the effects of probiotic supplement in children with attention-deficit hyperactivity disorder (adhd),40 patients will be randomly allocated to two groups of intervention and placebo. the intervention and the placebo group will be prescribed with 1 capsule of probiotics and placebo for 8 weeks, respectively. treatment efficacy will be assessed via administrating the conners's rating

both probiotics and placebo groups will receive medication with ritalin in a dose-dependent manner, starting at the onset of the study and simultaneous with probiotic supplementation. children weighed 30 kg or less receive 0.3 mg/kg of ritalin in 3 separate intervals and after four weeks the dosage will increase to 0.5mg/kg. those who weighed more than 30 kg receive 0.5 mg/kg with the same pattern that reaches the highest point of 0.7 mg/kg by week four. each dosage will be administrated trice a day with breakfast, lunch, and dinner. in the middle of the study patients who consumes less than 80% of their supplements will be omitted from the study.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of attention deficit hyperactivity disorder * having an intelligence quotient more than 85 based on wechsler test for children * willing to participate in the study exclusion criteria: * history of any other mental and psychological disorder such as depression, chronic motor tic disorder, communication disorder, learning disability * taking any stimulant, sedative, anti-anxiety and anti-psychotic medications * history of any chronic disorders, requiring long term medication (such as cancers, cirrhosis, autoimmune disorders, metabolic disorders ) or, chronic neurological disorders (such as epilepsy)

Keywords: adhd, probiotics, children
iit study on the use of medical bio glue for repairing meniscus tears

Conditions: Unilateral Meniscus Tear of the Knee Joint

Summary: to evaluate the safety and effectiveness of water triggered medical bioadhesive for meniscus tear repair


Eligibility criteria:
inclusion criteria: * 1. the patient is aged between 18 and 60 years old (including 18 and 60 years old), regardless of gender; 2. unilateral meniscus tear of the knee joint; 3. normal joint range of motion; 4. the subjects agree to participate in this trial and sign the "subject informed consent form". exclusion criteria: * 1. body mass index bmi\>32 kg/m2 (bmi=weight divided by height squared); 2. patients with abnormal lower limb force lines that require correction; 3. patients with multiple ligament injuries or complete meniscectomy; 4. individuals with a history of allergies to biological glue as the chief complaint; 5. patients with more than 2 or extensive cartilage defects in a single knee joint, and patients with bilateral knee joint cartilage defects; 6. those who have undergone open knee surgery within the past 6 months; 7. pregnant or lactating women, or those who plan to conceive during the trial period, and those whose blood hcg test results are positive before the trial; 8. patients with infectious, immune, or metabolic arthritis in the knee joint; 9. patients who participated in any other clinical trial or did not reach the trial endpoint within the first 3 months prior to enrollment; 10. other circumstances determined by the researcher to be unsuitable for inclusion in this study.

Keywords: meniscus tear
exploratory study: covid-19 and pregnancy

Conditions: Pregnant Women; Covid19

Summary: the sars-cov-2 infection may behave differently in pregnant and postpartum women in the short and long term. several risk factors or medication use can interfere on disease' evolution and vertical transmission. thus, due the current pandemic and the scarcity of scientific studies involving pregnant women with covid-19 or positive serology, combined with the need to elucidate the behavior of this viral infection in pregnant women in our population, this study aims to evaluate the clinical and laboratory evolution, transplacental passage, gestational and neonatal outcomes in pregnancies with positive sars-cov-2.


Eligibility criteria:
inclusion criteria: * pregnant women with clinical symptoms or positive serology for sars-cov-2 hospitalized or in delivery time; * asymptomatic pregnant women for sars-cov-2 during pregnancy and hospitalized for delivery at hu-usp. * pregnant women diagnosed with sars-cov-2 prior to delivery and who, after the quarantine period, followed prenatal care and delivered at the hu-usp or hcfmusp. exclusion criteria: * non-confirmation of maternal sars-cov-2 infection in pregnant women hospitalized or in delivery time. * withdrawal of pregnant woman to continue in the study.

Keywords: pregnancy sars-cov-2 vertical transmission
efficacy of the mckenzie method in patients with chronic non-specific low back pain

Conditions: Non-specific Chronic Low Back Pain

Summary: the purpose of this study is to assess the efficacy of the mckenzie method in patients with chronic non-specific low back.

one hundred and forty-eight patients will be randomly allocated to two treatment groups: mckenzie method or placebo (detuned ultrasound and short wave therapy) for 5 weeks (total of 10 sessions of 30 minutes each). the clinical outcomes will be obtained at the completion of treatment (5 weeks) and at 3, 6, and 12 months after randomization. the data will be collected by a blinded assessor. the statistical analysis will follow the intention-to-treat principles and the between-group differences will be calculated by constructing mixed linear models.

Eligibility criteria:
inclusion criteria: patients seeking care for chronic non-specific low back pain (defined as pain or discomfort between the costal margins and the inferior gluteal folds, with or without referred symptoms in the lower limbs, for at least 3 months), with a pain intensity of at least 3 points measured by a 0-10 points pain numerical rating scale, aged between 18 and 80 years and able to read in portuguese. - exclusion criteria: patients will be excluded if they have any contraindication to physical exercise or ultrasound or short wave therapy, evidence of nerve root compromise (i.e one or more of motor, reflex or sensation deficit), serious spinal pathology (such as fracture, tumor, inflammatory and infectious diseases), serious cardiovascular and metabolic diseases, previous back surgery and pregnancy. -

Keywords: low back pain mechanical low back pain low back ache low backache lower back pain lumbago
a double-blind evaluation of adverse effects of bath with wipes impregnated with 2% chlorhexidine versus placebo

Conditions: Bed Bathing

Summary: traditional bed bathing have been related to cross-infection. in order to avoid this complication, single-use products such as wipes impregnated with chlorhexidine use is increasing. nevertheless among nursery staff concern about its side effects prevents its widespread use. the investigators want to know if there are any differences between the use of 2% chlorhexidine wipes and a placebo concerning side effects.

hygiene is part of health recovery in patients, nevertheless in unconscious or sedated patients this procedure becomes a task for the nursing staff. traditional soap and water bed bath is becoming obsolete as soap could induce skin injuries due to changes in the ph of the skin and furthermore, almost every items used for this procedure could be a reservoir for pathogens, and therefore could lead to infection. nowadays single-use products are a new option for prevent cross-infections. nevertheless, traditional bed bathing is a tightly established practice among nursing staff. new evidence about side effects and comfort by wipe bed bathing is needed. chlorhexidine impregnated wipes have been used to perform the bed bathing in severe ill patients, as it can protect them from infections. the aim of this study is to determinate if bed bathing with 2% chlorhexidine impregnated wipes has a similar effect that a placebo.

Eligibility criteria:
inclusion criteria: * healthy adult volunteer exclusion criteria: * history of skin allergies or atopy, as well as reactions to soaps or chlorine compounds.

Keywords: antiseptics administration cutaneously chlorine compounds infection control anti-infecting agents, local
the lipid-rich plaque study

Conditions: Coronary Artery Disease; Atherosclerosis

Summary: the purpose of this study is to enhance medical knowledge of the causes of future coronary problems. many studies in patients who have already experienced a coronary problem point to the danger associated with plaques that are rich in cholesterol. this study determines if the near-infrared method of detection of these fatty plaques can predict future events. if dangerous plaques can be identified, there are many treatments already available that could be tested for their ability to prevent coronary events.


Eligibility criteria:
general inclusion criteria: * subjects presenting for coronary angiography in whom ivus imaging is likely to be performed for clinical purposes. * greater than 18 years of age. * clinical presenting symptoms meeting one of the three criteria below: 1. subjects presenting with an acute coronary syndrome (acs) including at least one of the following: 1. elevated cardiac biomarkers with ck-mb or troponin greater than upper limits of normal; 2. st depression or st elevation \>1mm in 2 or more contiguous leads in the absence of lvh, paced rhythm, bbb or early repolarization; 3. a stabilized patient 24 to 72 hours post stemi; 2. unstable angina pectoris; 3. stable angina pectoris and/or a positive functional study with evidence of ischemia. angiographic inclusion criteria * at least one suspected index culprit lesion requiring imaging with ivus and/or nirs for clinical indications. * at least two native epicardial coronary arteries (which may include the suspected index culprit artery) eligible for imaging with nirs-ivus. ivus/nirs imaging inclusion criterion * a minimum of a total 50 mm of coronary artery not involved in a prior or index procedure pci (including the 5mm borders on either edge of the site receiving pci) must be scanned. this 50mm total length may include contributions from the suspected index culprit arteries and from index non-culprit arteries. this total length must include contributions from two or more native imaged arteries. exclusion criteria: * unstable patients (stemi within the prior 24 hours; cardiogenic shock, hypotension needing inotropes, hypoxia needing intubation, and iabp) and patients that had a procedural complication (coronary dissection, perforation or a complication that would necessitate immediate-unplanned revascularization) during index pci procedure. * history of cabg or planned cabg within 6 months following nirs-ivus imaging. * patient has additional lesion(s) that needs a staged pci. * subject life expectancy is less than 2 years at time of index catheterization. * subject with ejection fraction (ef) \<30%. * subject pacemaker dependent/paced rhythm. * subject pregnant and lactating. * any other factor that the investigator feels would put the patient at increased risk or otherwise make the patient unsuitable for participation in the protocol * patients undergoing performance of pci in all three major vessels during the index pci.

Keywords: lipid vulnerable plaque plaque cholesterol near infrared spectroscopy nirs-ivus intravascular ultrasound angiography coronary imaging
improving antihypertensive medication adherence

Conditions: High Blood Pressure; Substance Abuse

Summary: poor adherence to antihypertensive medications is associated with morbidity, and data suggest that substance abuse may contribute to poor adherence. contingency management (cm), an intervention highly efficacious for improving outcomes of substance abusers, shows promise in improving medication adherence in a handful of small trials. cm involves providing tangible reinforcement each time the behavior (medication ingestion) is exhibited. thus far, studies evaluating cm for increasing medication adherence have utilized mems caps, but reinforcement of adherence via mems caps is done relatively infrequently and with delay, hindering its efficacy. a widely utilized technology that may be more appropriate for reinforcing medication adherence is cell phones, which can record the process of pill ingestion through video functions. as regular monitoring and feedback is important in the efficacy of cm, patients can be provided with daily messages regarding adherence and cm earnings. in this pilot study, we propose to randomize 40 hypertensive substance abusing patients with suboptimal adherence to antihypertensive medications to one of two 12-week treatment conditions: (1) usual care, or (2) usual care with cell phone monitoring and cm. in the cm condition, patients will carry a cell phone and record and send in time- and date-stamped self videos of medication ingestion. these patients will receive congratulatory messages or reminders about adherence, and they will earn vouchers each time medication ingestion occurs at the appropriate time, along with bonuses for sustained adherence. we hypothesize that the cm condition will improve self report and pill count measurements of medication adherence and that it will result in decreased blood pressure. results from this study may have widespread implications for the use of cell phones as a novel technology to improve medication adherence.


Eligibility criteria:
inclusion criteria: * age \>18 years * have been prescribed one or more antihypertensive medications * blood pressure of \>120 mmhg systolic or \>80 mmhg diastolic * substance use problem * willing to use a cell phone to record medication ingestion for three months * have a valid photo id (driver's license, passport, state id) and are willing to sign an off-campus property transfer form and return study equipment at the end of study participation exclusion criteria: * uncontrolled psychiatric disorders * significant cognitive impairment * non-english speaking
a maralixibat expanded access program for patients with cholestatic pruritus associated with alagille syndrome (algs)

Conditions: Alagille Syndrome

Summary: an open-label, single-arm, multi-centre program providing treatment access to algs patients with cholestatic pruritus in the us. access can be requested through clinigen healthcare ltd via email mirumalgs@clinigengroup.com or telephone +1-877-768-4303.

the objective of this eap is to provide access to maralixibat for eligible algs patients with cholestatic pruritus. participants will be treated with 400 µg/kg/day with safety and tolerability evaluated on an ongoing basis.

Eligibility criteria:
inclusion criteria: 1. informed consent and assent provided, as applicable, per institutional review board (irb) or ethics committee (ec) 2. clinical and/or genetic diagnosis of algs 3. male or female participants aged \>12 months and ≥5 kg with clinically significant cholestatic pruritus associated with algs 4. willingness to adhere to an acceptable method of contraception until treatment discontinuation by females of childbearing potential who are sexually active or who become sexually active during the program 5. no other therapeutic options or access to any ongoing algs clinical trials exclusion criteria: 1. diagnosis with a cholestatic liver disease other than algs 2. female who is pregnant or breastfeeding 3. clinically significant cardiovascular, hepatic, gastro-intestinal, pulmonary, neurologic, infectious or renal disease or other medical condition that, in the opinion of the physician or medical monitor, would preclude participation in the program 4. past medical history of compensated or decompensated cirrhosis 5. presence of any other disease or condition known to interfere with the absorption, distribution, metabolism, or excretion of maralixibat or its mode of action

Keywords: liver disease algs maralixibat bile duct diseases digestive system diseases biliary tract diseases cholestasis pruritis
efficacy and safety study of mp-513 in combination with thiazolidinedione in patients with type 2 diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to evaluate the efficacy and safety of mp-513 (teneligliptin) in combination with thiazolidinedione (pioglitazone) in patients with type 2 diabetes for 12 weeks administration and to evaluate the safety and efficacy of mp-513 in combination with thiazolidinedione with an extension treatment for up to 52 weeks.


Eligibility criteria:
inclusion criteria: * patients who are 20 - 75 years old * patients who are under dietary management and taking therapeutic exercise for diabetes over 12 weeks before administration of investigational drug * patients whose hba1c is between 6.5% and 10.0% * patients who took thiazolidinedione for diabetes over 16 weeks before administration of investigational drug * patients who were not administered diabetes therapeutic drugs prohibited for concomitant use within 12 weeks before administration of investigational drug. exclusion criteria: * patients with type 1 diabetes, diabetes mellitus caused by pancreas impairment, or secondary diabetes (cushing disease, acromegaly, etc) * patients who are accepting treatments of arrhythmias * patients with serious diabetic complications * patients who are the excessive alcohol addicts * patients with severe hepatic disorder or severe renal disorder. * patients who are pregnant, lactating, and probably pregnant patients, and patients who can not agree to contraception

Keywords: insulin resistance