Kornimate/medical-research-clean huggingface dataset:
cognitive behavioural group therapy for perinatal anxiety

Conditions: Perinatal Anxiety

Summary: this study evaluated the effectiveness of a 6-week, group-based, cognitive behavioural therapy (cgbt) program for women with anxiety disorders (with or without comorbid depressive symptoms) during pregnancy or early postpartum. the cbgt program was evaluated compared to a 6-week waitlist condition.

anxiety disorders affect up to 15% of women in the perinatal period (i.e., pregnancy, postpartum) and are a serious mental health concern. anxiety disorders often coexist with depression and result in high distress and an impaired ability for new mothers to take care of themselves and their babies. in spite of the high prevalence of anxiety disorders during pregnancy and postpartum, research and clinical attention in this area is lacking and no empirically supported psychological treatments exist. further, since many pregnant or postpartum women are unable or choose not to take medication for their mental health symptoms, establishing an effective non-pharmacological alternative is imperative. cognitive-behavioural therapy is a well established psychological treatment for anxiety and mood disorders, with moderate to large effect sizes (cohen's d = 0.5-1.3). the investigators developed a novel group-based cognitive-behavioural treatment program (cbgt) for perinatal women with anxiety disorders. in an initial, single-sample pilot study (green et al., 2015), a significant reduction in symptoms of anxiety and depression was found from pre to post-treatment, along with reported high levels of treatment satisfaction. the purpose of the current study is to evaluate the effectiveness of this treatment using a larger sample and a randomized controlled trial (rct).

Eligibility criteria:
eligibility criteria: 1. 18-45 years of age 2. pregnant or within the first six months postpartum 3. principal diagnosis of an anxiety disorder with or without comorbid depression 4. not taking psychoactive medication or, if taking these medications, no change in dose and type ≥ 6 weeks prior to the baseline assessment 5. no changes in psychoactive medication during the 6-week cbt treatment or 6-week waitlist 6. fluent in english exclusion criteria: 1. severe depression or active suicidal ideation 2. current psychosis or substance use disorder

Keywords: cognitive-behavioural therapy (cbt)
atrial fibrillation with sinus node dysfunction: intensive device follow-up

Conditions: Sinus Node Dysfunction; Atrial Fibrillation

Summary: the study will try to access the efficacy of atrial pacing, medication and radiofrequency ablation in treating patients with paroxysmal atrial fibrillation and sinus node dysfunction; to identify the response to these treatments in patients with "functional" and organic sinus node dysfunction respectively; to explore the necessity of pacemaker implantation in patients with "functional" sinus node dysfunction. patients who meet the inclusion criteria will receive pacemaker implantation followed by trial pacing, medication and radiofrequency ablation of af. device data will be analyzed to answer the question. and after follow-up of 1 year, lower rate of pacemaker will be set as 40 bpm for patients without af. the proportion of pacing and patients' tolerance will be analyzed.


Eligibility criteria:
inclusion criteria: * age from 18 - 80 years * longest rr interval ≥ 3 seconds in sinus rhythm or when atrial arrhythmia (atrial fibrillation/atrial arrhythmia/atrial flutter) is converted to sinus rhythm (documented by either holter monitor or electrogram). * meet the indications of permanent pacemaker implantation in patients with snd according to the 2012 accf/aha/hrs guidelines for device-based therapy of cardiac rhythm abnormalities. * evidence of paroxysmal atrial fibrillation ( two or more symptomatic episodes within 6 months) * willing to sigh informed consent exclusion criteria: * type ii second-degree or three-degree atrioventricular block (in sinus rhythm) * intrinsic pr interval ≥ 300 ms in sinus rhythm * persistent af（including long-standing persistent af） * severe structural heart disease(e.g. ischemic heart disease that requires revascularization, rheumatic heart disease that requires valve replacement, cardiomyopathy except hypertensive myocardial hypertrophy) * work high above the ground or heavy physical labour * malignant ventricular arrhythmias * new york heart association (nyha) class iii or iv * af secondary to electrolyte imbalance, thyroid dysfunction, vasovagal reaction or other reversible or non-cardiac causes * previous procedures dealing with af (including radiofrequency ablation and surgical operation) * cardiac implantable electronic device implantation history * severe hepatic and renal dysfunction(serum creatinine above the upper normal limit of the center, or chronic renal dysfunction ; alt or ast more than 2 times the upper normal limit of the center, or bilirubin more than 2 times the upper normal limit of the center, or hepatic cirrhosis) * contraindication to propafenone/amiodarone/dronedarone(except bradycardia) * contraindication to oral anticoagulants * women who are pregnant * presence of malignant tumor * severe coagulation disorder (without any anticoagulation treatment) * the investigators do not think the patient is eligible for this study * patient is unwilling to cooperate with the study procedures
effect of standardized lacrimal sac massage compared with probing for congenital lacrimal duct obstruction

Conditions: Nasolacrimal Duct Obstruction

Summary: congenital nasolacrimal duct obstruction (cnldo) is a common ophthalmic condition in children, presenting with tearing and pus overflow, with a prevalence of 5%-20% within 1 year of age. although most cases resolve spontaneously within 1 year of age, some children require treatment. lacrimal sac massage is a non-invasive, easy and cost-effective conservative treatment that helps to unblock the obstruction by increasing the pressure in the tear duct. studies have shown that massage has a 93% cure rate in children under 8 months of age. in contrast, tear duct probing is effective but invasive and risky. in recent years, with the development of minimally invasive techniques, lacrimal sac massage has received renewed attention, and studies have shown its efficacy to be comparable to probing. however, there are problems of non-standardized massage timing and techniques in clinical practice, which affects the therapeutic efficacy. this study aims to assess whether the efficacy of standardized dacryocystic massage is not inferior to that of dacryocystorhinostomy through a randomized controlled trial, providing a reference for the treatment of cnldo.


Eligibility criteria:
inclusion criteria: 1. age from 3 months to 1 year; 2. presence of at least one symptom of cnldo (tear spillage, mucous discharge) in one or both eyes; 3. no surgical treatment for nld (probing, balloon dilation, tube placement, dcr, etc.); 4. can cooperate with the examination and subsequent follow-up; 5. guardians agreed to be enrolled in the study and signed an informed consent form. exclusion criteria: 1. combination of presenting infections of the conjunctiva and cornea; 2. combination of other serious ocular surface and intraocular disorders that may affect the therapeutic effect; 3. congenital malformation syndromes, developmental delays, facial anomalies, facial deformities; history of surgery or injury to the lacrimal duct, history of punctal occlusion, history of lacrimal fistula, history of congenital bulging of the lacrimal sac, history of acute dacryocystitis, history of severe blepharitis, and perinatal abnormalities such as preterm labor, low birth weight, and so on;
acupuncture for chemotherapy-induced peripheral neuropathy

Conditions: Chemotherapy Induced Peripheral Neuropathy

Summary: in this study, a 24-week, single blinded, randomized controlled clinical trial will be conducted to examine the efficacy and safety of acupuncture for chemotherapy induced peripheral neuropathy (cipn) in colorectal cancer patients in hong kong.

this is a pilot single-blind, randomized, sham-controlled trial. 84 colorectal cancer patients will be randomly assigned to acupuncture group or control group. the duration of the treatment will be 12 weeks with 1 session per week and the follow-up period will be 12 weeks.

Eligibility criteria:
inclusion criteria: * aged ≥18 years old * newly diagnosed with stage ⅱto ⅲcolorectal cancer * who plan to receive 8 cycles of adjuvant oxaliplatin-based chemotherapy * who have not received any acupuncture * life expectancy of ≥ six months. exclusion criteria: * uncooperative subjects * not be able to comprehend and communicate * non-chinese reading people * having peripheral neuropathy caused by other diseases, for example, diabetes, stroke * heart disease, for example, arrhythmia, heart failure, myocardial infarction or patients with pacemakers * having a bleeding tendency * be pregnant or lactating women * having impaired hepatic or renal function * using any pharmaceutical agents (for example, gabapentin, pregabalin), nutraceutical agents (for example, vitamin b6, vitamin e) and herbal medication for cipn treatment.
pyruvate kinase (pk) deficiency global longitudinal registry: patient-reported outcomes (pro)

Conditions: Pyruvate Kinase Deficiency; Pyruvate Kinase Deficiency Anemia; Anemia; Anemia, Hemolytic

Summary: the primary objective of this study is to understand and characterize the health-related quality of life (hrqol) and disease burden of adult participants with pk deficiency receiving routine clinical care. this study is an observational (i.e., noninterventional), longitudinal, multicenter, global registry for participants with pk deficiency, a rare nonspherocytic hemolytic anemia. this study will be open for enrollment for 2 years and all enrolled participants will be followed prospectively for up to 96 weeks. data will be collected from participants who have provided informed consent and authorization pursuant to applicable laws and regulations.

participants aged ≥18 years and previously enrolled in study ag348-c-008 (nct03481738) will be eligible to participate in this study. data will be submitted via electronic patient-reported outcomes (epro) application. all data collection efforts will abide by this protocol and be prospectively disclosed in the study informed consent. this study, with the appropriate participant (and or parent/guardian) consent/assent, may incorporate retrospective data from other properly consented studies done for the purpose of examining the longitudinal natural history of pk deficiency.

Eligibility criteria:
inclusion criteria: * participant must be greater than or equal to (≥)18 years of age; * participant must be enrolled in study ag348-c-008. exclusion criteria: - participant is enrolled in an agios-sponsored clinical study involving treatment with a pyruvate kinase activator.

Keywords: glycolytic enzymopathy congenital nonspherocytic hemolytic anemia pkd cnsha
long term safety of gw685698x via nasal biopsy

Conditions: Rhinitis, Allergic, Perennial

Summary: long term safety (52 weeks) of gw685698x on the nasal mucosa via nasal biopsy with an active control group (nasonex®) and a healthy volunteers control group in subjects 18 years old with perennial allergic rhinitis . allergic rhinitis is an inflammatory disorder of the upper airway that occurs following allergen exposure. perennial allergic rhinitis is triggered by house dust mites, animal dander, etc., possibly causing symptoms year-round including nasal congestion, rhinorrhea and/or nasal itching.

a randomized, open label, active controlled (mometasone furoate aqueous nasal spray \[nasonex®\] 200mcg qd), parallel group, multi-center, 52-week study to assess the long term safety of gw685698x aqueous nasal spray 100mcg qd via nasal biopsy in subjects \>18 years of age with perennial allergic rhinitis (par)

Eligibility criteria:
inclusion criteria: * history of perennial allergic rhinitis of 2 years, with a documented positive allergen test to an appropriate allergen. * female patients of child-bearing potential must be willing to consistently and correctly use an acceptable method of birth control. exclusion criteria: * patients who require certain medications for their allergy. * patients with serious medical problems.

Keywords: perennial allergic rhinitis nasal biopsy gw685698x
neuronavigated repetitive transcranial magnetic stimulation (nrtms) of the dorsolateral prefrontal and primary motor cortex for the treatment of chronic pain

Conditions: Chronic Pain

Summary: this study investigated the effects of navigated repetitive transcranial magnetic stimulation on nociception and quality of life in patients suffering from chronic pain conditions. two cortical targets (dorsolateral prefrontal cortex/dlpfc and m1 area) were stimulated and compared to sham stimulation.

from 34 patients, 24 completed the study. the m1-area was stimulated with 10 hz rtms while the dlpfc received a 5hz stimulation. in total, 13 session were administered over a period of 36 weeks with most frequent stimulation in the first 4 weeks of the trial. results were compared to sham-tms over the m1 area at the same schedule than the actual therapy. outcome parameters included the german pain questionnaire (gpq), the depression, anxiety and stress scale" (dass) and quality of life (qol) with the sf-12 questionnaire.

Eligibility criteria:
inclusion criteria: * age between 18 and 80 years * clinical diagnosis of chronic lbp (low back pain) and or neck pain * average resting pain-level \> than 3 in the numeric rating scale (0-10) * no changes in pain medication 4 weeks at baseline * no surgical procedures in the last 2 years exclusion criteria: * metallic and electronic implants in the head, neck and chest * medication e.g. tetracyclic antidepressants, antiviral, antipsychotic, opioid doses \> 100mg orally/d * history of frequent headache or tinnitus * alcohol or drug abuse * pregnant patients * breastfeeding patients
stroke self-management delivered by rehabilitation assistants within an early supported discharge service

Conditions: Stroke

Summary: this feasibility study evaluates whether it is possible to run a larger scale study to investigate the use of a self-management programme with adults who have recently had a stroke. half of the participants will receive support with self-management from stroke therapists, while the other half will receive it from rehabilitation assistants.

supporting self-management post-stroke is a key priority in healthcare policy, but not yet embedded into the provision of stroke rehabilitation. barriers to implementation include time and resource. the feasibility of using the bridges stroke self-management programme within an early supported discharge service and delivery by rehabilitation assistants is unknown. the aim of this study was to evaluate key trial parameters to inform the protocol of a future definitive trial into the effectiveness of bridges delivered by rehabilitation assistants within an early supported discharge service.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of new stroke * being referred to the esd service * medically stable * able to give informed consent * can follow a two-stage command exclusion criteria: * being discharged to a care home

Keywords: self-management rehabilitation
microbiota in dietary approach to obesity

Conditions: Obesity

Summary: main aim: study the anthropometric, metabolic, cardiovascular and neurocognitive and gut microbiota changes of different approaches for the weight reduction that increase the ketone bodies in a different proportion in relation to the classic hypocaloric diet. objective 1: study the effect of hypocaloric diets that increase the ketone bodies on gut microbiota and its relationship with anthropometric changes and of the brown adipose tissue, objective 2: with the metabolic and inflammatory changes, objective 3: on the cardiovascular system, objective 4: on the neurocognition, objective 5: if they are associated to epigenetic changes that may explain the changes found in the other objectives. objective 6: determine the safety of the diets that increase the ketone bodies compared to the classic hypocaloric diet, objective 7: if the effects of the different dietary approaches are maintained during the medium time, and objective 8: verify in experimental models (microbiota transplants from humans with different diets to germ-free mice, ketosis dietary models, and ketone bodies administration) the causality of the gut microbiota of these findings. methodology: model 1: dietary intervention in humans with 4 types of diet with a different increase of the ketone bodies: classic hypocaloric diet (dh); diet with 8h of feeding and 16h of starving in periods of 24h (d16); diet with intermittent caloric restriction (da); and normal in protein and low in carbohydrates hypocaloric ketogenic diet (dc).


Eligibility criteria:
inclusion criteria: * obesity (bmi≥30-45 kg/m2) exclusion criteria: * type 2 diabetes mellitus * patients with major cardiovascular events in the 6 months prior to the study beginning. * previous or current history of inflammatory disease. * active infectious disease. * the refusal of the patient to participate in the study * consumption of probiotics or prebiotics * antibiotic therapy in the 3 months prior to the study

Keywords: ketosis microbiota
senior elastic band (seb) on institutional elders

Conditions: Institutional Older Adults

Summary: the goals of this research project are: 1) to develop and evaluate the safety and feasibility of the senior elastic band (seb) exercise program for elderly residents in long term care facilities, 2) to evaluate the long-term effects of the seb on physical functional fitness and sleep quality of elderly residents in long term care facilities, and 3) to investigate the compliance of elderly residents with long-term seb exercises.

a three-year, longitudinal, triangulation research method will be used. the study purpose of the first year is to develop a safe and appropriate seb program for the elderly residents in long term care facilities using delphi survey with a panel of 12 experts and pilot-testing on a group of 15-20 elderly residents in long term care facilities. in the second year of the study, a quasi-experimental, non-equivalent control group design will be used to evaluate the effects of the seb exercise program on the physical functional fitness (cardiovascular-respiratory function, body flexibility, muscle power/muscle endurance, and balance) and sleep quality of elderly residents in long term care facilities. through the convenience sampling strategy, a total of four long term care facilities with approximately 120 elders in kaohsiung will be recruited and randomly assigned based on the resided facilities to a seb experimental group or a waiting-list control group. the subjects in the experimental group will receive the seb interventions lead by the certified instructors, three times per week, 40 minutes per practice for six months; the subjects in the waiting-list control group will remain regular daily activities in the facilities. all subjects will receive one pre-test and two post-tests three months apart during the study. in the third year, the elderly participants will continue practicing the seb guided by a vcd for another nine months, and the compliance of the participants toward regular seb exercise and its long-term effects on the physical functional fitness and sleep quality outcomes will be tested with additional three post-tests, three months apart.

Eligibility criteria:
inclusion criteria: * elderly residents aged 65 and over * mandarin or taiwanese speakers * have been living in the facility for at least 3 months * able to stand alone without assistive devices * cognitively alert and able to verbally state their name, address, and answer questions. exclusion criteria: * participants with severe and acute cardiovascular, musculoskeletal, or pulmonary illnesses

Keywords: elastic band institutional elders functional fitness sleep quality depression
energy transfer therapy in treatment of medial gastrocnemius

Conditions: Strain of Gastrocnemius Muscle (Diagnosis); Diathermy Plate Burn; Thermography; Sports Physical Therapy

Summary: this study develops the effects of capacitive and resistive energy transfer therapy (tecar) on medial gastrocnemius using thermographic cameras, algometry and lunge tests, in a pre-post study with basketball players using a control group to which placebo is applied. (simulated technique) and an intervention group to which the technique is performed. the main objective of the study is to establish whether the tecar produces physiological and mechanical changes in the subjects that improve muscle recovery.


Eligibility criteria:
inclusion criteria: * male players * semi-professional players who are currently active * not have suffered a lower limb injury in the last 6 months before the study * not having suffered a rupture of the triceps surae * contain a latent trigger point in the medial gastrocnemius exclusion criteria: * players suffering from any disease that could alter the study or be contradictory
clinical trial of pioglitazone for prevention of cardiac allograft vasculopathy after heart transplantation

Conditions: Cardiac Allograft Vasculopathy

Summary: the purpose of this study is to determine the benefit of using the fda-approved insulin-sensitizing agent, pioglitazone, on human heart transplant recipients. the objectives of this project are to (1) determine if pioglitazone effectively treats insulin resistance in heart transplant recipients, and (2) to determine whether pioglitazone therapy after heart transplantation impacts the development or progression of cardiac allograft vasculopathy (cav), a form of chronic rejection after heart transplantation.

cav, a rapidly progressive obliterative disease involving the graft coronary arteries, is the leading cause of morbidity and mortality beyond the first year after heart transplantation. this common complication occurs in almost half of recipients within 3 years after heart transplantation, and is associated with high rates of graft failure and mortality. clinical care of heart transplant recipients in the current era is greatly limited by the lack of effective treatment options to prevent or retard the progression of cav. cav appears to be strongly associated with the state of insulin resistance, which is present in over half of heart transplant recipients and is characterized by metabolic abnormalities including glucose intolerance, dyslipidemia, endothelial dysfunction, and high levels of circulating inflammatory markers. insulin resistance can be effectively treated with pioglitazone, a tzd compound which directly affects tissue insulin sensitivity. in this study, we will enroll 32 insulin-resistant heart transplant recipients and will randomize them to pioglitazone or placebo for a one-year period. we will determine the efficacy of pioglitazone for the treatment of insulin resistance and prevention of the development and progression of cav after heart transplantation. the data generated from this study will provide important preliminary data for future, larger-scale clinical investigations.

Eligibility criteria:
inclusion criteria: 1. heart transplant recipients, years 1-4 post-transplant 2. age \>= 18 years 3. fasting tg/hdl ratio\>=3.0 or fasting tg\>=150 mg/dl exclusion criteria: 1. diabetes mellitus 2. severe liver dysfunction (alt\>=2.5 x upper limit of normal) 3. severe renal dysfunction (gfr\<30 or stage iv ckd) 4. moderate-severe fluid retention 5. clinical or echocardiographic signs of left ventricular dysfunction 6. contraindication to coronary angiography and/or ivus

Keywords: cardiac allograft vasculopathy pioglitazone insulin resistance heart transplant