Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of peripheral, cobalt-chromium sirolimus eluting stent (pers) versus cobalt-chromium stent (neptune c)

Conditions: Peripheral Arterial Disease

Summary: the aim of this study is to assess the safety and efficacy of pad treatment by revascularization with new cobalt-chromium sirolimus stent implantation, which is expandable on balloon pers (cocr ses) compared to cobalt-chromium balloon-expandable (neptun c) stent (cocr bms) in patients with symptomatic iliac arteries disease requiring revascularization.


Eligibility criteria:
inclusion criteria: 1. de novo lesion or restenosis without previously implanted stent, in a common or external iliac artery with a reference diameter of 5 to 12 mm, length up to 10 cm and stenosis ≥ 50% and ≤ 99% (in quantitative assessment by peripheral angiography), which may be treated with one stent or total occlusion of vessels up to 50 mm long. 2. ability to cross the lesion with guidewire (assessed during diagnostic angiography). 3. abi ankle-brachial index \<0.9. 4. signs of lower limb ischemia based on the rutherford scale in the range from 2 to 4. 5. age ≥ 18 years. 6. patient signed informed consent form. exclusion criteria: 1. life expectancy less than two years. 2. chronic kidney disease in stage iii-v. 3. lesion in the previously implanted by-pass. 4. target lesion is a chronic total occlusion of significant length, not eligible for percutaneous revascularization. 5. acute lower limb ischemia. 6. stenosis (\> 50%) or occlusion proximally to the lesion being treated. 7. angiographically confirmed thrombus in the lesion to be treated. 8. treatment requires an atherectomy to deliver stent to treated lesion. 9. known allergy or hypersensitivity to clopidogrel. 10. hemorrhagic stroke in the last three months. 11. contraindications for acetylsalicylic acid (hypersensitivity, hemorrhagic diathesis). 12. pregnancy or women of childbearing potential not using effective contraception. 13. active inflammation at the planned access site.
hypnosis in treating hot flashes in breast cancer survivors

Conditions: Breast Cancer; Cancer Survivor; Hot Flashes

Summary: rationale: hypnosis may be effective in decreasing hot flashes in breast cancer survivors. purpose: this randomized clinical trial is studying how well hypnosis works in treating hot flashes in breast cancer survivors.

objectives: * determine the efficacy of hypnosis in controlling hot flashes in women who are breast cancer survivors. * determine the extent to which hypnotizability is related to the success of the hypnotherapy intervention. outline: this is a randomized, controlled study. patients are stratified according to age, gender, race, and educational background. all patients complete a hot flash daily diary to record frequency and severity of hot flashes for 1 week. patients are then randomized to 1 of 2 treatment arms. * arm i (hypnotherapy): patients undergo hypnotherapy once a week for 5 weeks. patients complete the hot flash-related daily interference scale, the hospital depression and anxiety sub-scale, the ces depression scale, and the mos-sleep and sexual function scales in week 5 after the last hypnotherapy intervention. patients also complete another hot flash daily diary for 1 week in week 6 and are administered the stanford hypnotic clinical scale in week 7. * arm ii (control): patients receive no contact for 4 weeks. patients complete the questionnaires as in arm i in week 5. patients also complete another hot flash daily diary for 1 week in week 6 and are administered the stanford hypnotic clinical scale in week 7. projected accrual: a total of 60 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * history of primary breast cancer * no evidence of detectable disease * at least 14 hot flashes per week for ≥ 1 month by self-reporting * hormone receptor status not specified patient characteristics: * female * life expectancy \> 6 months * menopausal status not specified * outpatient status * no medical or psychiatric condition that would preclude study participation prior concurrent therapy: * concurrent antihormonal agents for breast cancer (e.g., tamoxifen or raloxifene) allowed provided the patient has been on them for ≥ 1 month * no other concurrent hormonal therapy * no other putative therapies for hot flashes ≥ 1 month prior to study entry * concurrent vitamin e allowed * no other concurrent treatment for hot flashes * no concurrent cytotoxic chemotherapy * not concurrently using hypnosis for any reason

Keywords: cancer survivor stage ia breast cancer stage ib breast cancer stage ii breast cancer stage iiia breast cancer stage iiib breast cancer stage iiic breast cancer stage iv breast cancer breast cancer in situ inflammatory breast cancer hot flashes
treatment of panic disorder via internet with a wireless temperature biofeedback ring

Conditions: Panic Disorder

Summary: from the scarce literature it showed that computer/internet-aided cognitive behavior therapy (cbt) was superior to waitlist and placebo assignment across outcome measures, and the effects of computer/internet-aided cbt were equal to therapist-delivered treatment across anxiety disorders. the aim of this study is to evidence the effectiveness of internet-based relaxation with biofeedback treatment for panic disorder.

all participants had access to a computer with an internet connection and received the treatment via internet.

Eligibility criteria:
inclusion criteria: 1. the participant must fulfill dsm-iv criteria for panic disorder. 2. the participant must be between 20 and 60 years of age. 3. the participant must have the panic disorder severity scale(pdss) score ≧8. 4. if the participant is taking prescribed drugs for panic disorder, a) the dosage have to be constant for 6 weeks before starting treatment, and b) the participant have to agree to keep the dosage constant for 2 months after starting treatment. 5. if the participant was already in therapy, the contact must have lasted at least 3 months and not be based on cognitive behavior therapy. 6. all participants have access to a computer with an internet connection. exclusion criteria: 1. the participant suffers from any other psychiatric disorder in immediate need of treatment. 2. the participant fulfills dsm-iv criteria for major depression. 3. the participant has epilepsy, kidney problems, strokes, organic brain syndrome, emphysema, heart disorders, or chronic hypertension. 4. the participant has alcoholism or substance dependence.

Keywords: panic disorder cognitive behavior therapy internet
pudendal assessment in erectile dysfunction

Conditions: Erectile Dysfunction

Summary: the study will address the role of internal pudendal artery disease in erectile dysfunction (ed), and whether it might eventually be amenable to intervention with stenting. there is currently a small trial investigating the potential benefit of stenting for erectile dysfunction, but the relationship between pelvic arterial stenoses and erectile dysfunction is not yet proven. the investigators intend to perform angiography on patients both with and without erectile dysfunction, to see whether internal pudendal artery disease is more common in the population with erectile dysfunction. in addition to angiography, stenoses will be examined using fractional flow reserve. the degree of internal pudendal artery disease will then be correlated with the degree of erectile dysfunction using a validated questionnaire, the international index of erectile function (iief). patients will then complete iief questionnaires for 5 years to assess the relationship between internal pudendal artery disease and progression of erectile dysfunction.


Eligibility criteria:
inclusion criteria: * as above, men with one risk factor for ed such as age\>55, diabetes, hyperlipidemia, smoking, hypertension, coronary disease or peripheral arterial disease exclusion criteria: * patients with ed from a non-arterial cause, including hormonal, neurological, or trauma-related (as determined by past medical history routinely performed prior to catheterization) * patients requiring urgent catheterization (e.g. acute coronary syndrome or cardiogenic shock) * patients with a creatinine \>1.5 mg/dl and those deemed at increased renal risk (such as from receiving \>200 ml of dye during the primary procedure, post renal transplant or single kidney), as the additional contrast dye required for angiography would pose an undue risk of progressive kidney disease * patients with other illnesses that reduce their life expectancy to less than one year
endurance training in young persons with cerebral palsy; evaluation of training method and effect

Conditions: Cerebral Palsy

Summary: the hypotheses of the study are that children / youth with cp will by possibly use of technical aids be able to perform high intensity endurance training by walking / running on a treadmill, and that this training will improve their health by increased aerobic capacity and quality of life.


Eligibility criteria:
inclusion criteria: * person with cp, gmfcs-level i-iv, age 10-17 years * living in mid-norway * wants to increase his / her level of physical activity exclusion criteria: * completes less than 75% of the total number of training sessions * not able to complete the testing and training procedures due to sickness, injury or other physical and psychological conditions
efficacy, safety, and tolerability study of oral full-spectrum microbiotatm (cp101) in subjects with recurrent c. diff

Conditions: Clostridium Difficile Infection Recurrence

Summary: subjects with recurrent c. difficile infection will receive an oral dose of cp101 capsules one time in treatment group i or matching placebo one time in treatment group ii. the purpose of this study is to demonstrate the safety and effectiveness of cp101 to prevent recurrence of c. difficile. subjects with confirmed c. difficile recurrence within 8 weeks after administration of study drug (cp101 or placebo) may be eligible to enroll in the open-label extension study (cp101-cdi-e02) and will receive cp101.

this is a multicenter, double-blind, parallel-arm, placebo-controlled, phase 2 study of the efficacy, safety, and tolerability of oral full-spectrum microbiotatm (cp101) in subjects with recurrence of clostridium difficile infection (cdi).

Eligibility criteria:
inclusion criteria: * ability to provide written informed consent * men or women 18 years of age or older * current diagnosis of a recurrence of non-severe, non-complicated cdi * subject has a clinical response to standard-of-care cdi antibiotics for the most recent cdi episode exclusion criteria: * pregnant, breast-feeding, or considering becoming pregnant during the study * prior history, evidence, or diagnosis of inflammatory bowel disease (e.g., crohn's disease and ulcerative colitis) * any prior diagnosis of diarrhea-predominant irritable bowel syndrome * systemic chemotherapy or radiation for the treatment of cancer during the 60 days prior to consent or planned during the 8 weeks following randomization * prior fecal transplant for any condition, regardless of route of administration in the last year or plans to undergo during the study * major intra-abdominal surgery within the past 60 days prior to screening * history of total colectomy/ileostomy or bariatric surgery * admitted to, or expected to be admitted to an intensive care unit for any medical reason. note: residents of long term care facilities are eligible study entry * planned hospitalization or invasive surgery during the study * severe acute illness unrelated to cdi

Keywords: clostridium difficile infection cp101 crestovo fmt cdi c. difficile c. diff recurrent clostridium difficile infection recurrent c. diff recurrent cdi finch fecal transplant fecal microbiota transplant rcdi finch therapeutics
maternal mental health access - mama

Conditions: Postpartum Depression; Perinatal Depression

Summary: this hybrid effectiveness-implementation project will allow the team to evaluate and refine implementation in preparation for future multisite trials to ultimately move the evidence-based intervention (ebi) to scale among diverse populations. the plan is to enroll 120 at-risk pregnant and postpartum women from rural, urban, and latino populations. using a randomized preference design to also evaluate patient and sociocultural factors in participation and symptom trajectory. using the implementation research logic model, the team will evaluate the implementation feasibility and acceptability of a remote-access and on-demand mbct pd prevention intervention that is integrated within maternal clinical care settings using an existing patient portal. successful achievement of the study aims will result in a refined implementation protocol for future studies that are sufficiently powered to evaluate the effectiveness of an integrated digital mental health technology and to estimate the cost/benefit ratio

this type1 hybrid effectiveness-implementation project is conducted within healthcare settings and underserved populations (rural, urban, and latino) and for individuals who are at risk for perinatal depression (pd), which allows the team to refine the approach in preparation for a future effectiveness trial for the prevention of pd in diverse communities using accessible digital mental health technology (patient education portal, fb discussion boards, synchronous videoconference support sessions). the plan is to adopt a randomized preference trial design to assess the impact of patient preference and sociocultural factors (including race, ethnicity, and geographic residence) on engagement and preliminary results. this information is crucial for a subsequent trial and for ultimately taking the intervention to scale. the study design using the irlm reflects scientific rigor that can be reproduced by other investigators. the implemented strategies specifically developed to optimize implementation success, and to measure the implementation outcomes of these strategies and include valuable input from key informants, stakeholders, and the community advisory board at regular intervals throughout the project time period.

Eligibility criteria:
inclusion criteria: * 18+ years of age, who at the time of screening * have a viable pregnancy or are postpartum (up to 1 year) * identified as at-risk for pd (any one of the following: * epds score equal to or greater than 9 or less than 21 * history of depression/anxiety * 2 or more significant life events) * english- or spanish-speaking * currently attending a uhealth clinic or rural public health partner clinic. exclusion criteria: * have a substance use disorder * current diagnosis of serious mental illness, such as psychosis, schizophrenia, bipolar disorder, severe depression (including epds \> 20) * severe anxiety, suicidality, or currently taking any medications for a mental health condition.
hiatal hernia repair by tension-free mesh closure or simple suturing

Conditions: Hiatal Hernia

Summary: one-hundred and fifty-nine patients undergoing nissen fundoplication for symptomatic gastro-oesophageal reflux disease (gord), who had a concomitant hiatal hernia of \> 2 cm axial length, were randomized to closure of the diaphragmatic hiatus with either crural sutures alone or tension-free closure with a non-absorbable mesh. primary outcome variable was the incidence of radiologically verified recurrent hiatal hernia. secondary outcomes were per-and postoperative complications and courses, symptomatic recurrence rate, use of ppi, postoperative oesophageal acid exposure and quality of life.

the basic principles behind successful surgical repair of the anatomy and function of the gastro-oesophageal junction (goj) in gastro-oesophageal reflux disease (gord) is not only to encircle the distal oesophagus and goj by the fundic wrap but also to complete a transhiatal reduction of a concomitant hiatal hernia (type i, hh), aiming for a 2 - 3 cm intra-abdominal length of the of oesophagus and to transact a tension-free hiatal closure. the physiological and morphological characteristics of the diaphragmatic hiatus, however, carry a challenge for the selection of the ideal technique for surgical repair. the diaphragmatic hiatus consists of a three-dimensional structure in constant motion, which creates a border between the counteracting pressures prevailing in the abdominal and chest cavities, respectively. following hernia reduction, the structural quality of the diaphragmatic pillars is usually weak, offering poor support for the subsequent closure with risk for high recurrence rates. these and other considerations have encouraged the exploration of mesh reinforcement to enhance the durability of the hiatal closure.

Eligibility criteria:
inclusion criteria: * patients scheduled for elective laparoscopic total fundoplication * symptomatic gastro oesophageal reflux disease (gord) and hh of \> 2 cm in axial length * total esophageal acid exposure for more than 4 % of monitored time exclusion criteria: * if insufficient capacity prevailed to understand the study protocol, * if the patient had undergone previous major upper gastrointestinal surgery (except for gord or hh) * asa classification of \>2 .
does cardiac rehabilitation reduce the risk of recurrence of atrial fibrillation following the first catheter ablation?

Conditions: Atrial Fibrillation

Summary: many risk factors contribute to the onset of atrial fibrillation. this study is specifically concerned with the effect of addressing these risk factors by cardiac rehabilitation on the risk of recurrence of atrial fibrillation following catheter ablation. a non-randomized, retrospective study was performed on patients treated with a catheter ablation for atrial fibrillation. the intervention group consisted of patients who chose to participate in the cardiac rehabilitation program. the control group only received standard care. the primary objective was to examine whether cardiac rehabilitation following the first ablation for atrial fibrillation resulted in a reduction of the time to or the risk of recurrence of atrial fibrillation or the need for a second ablation within 1 year after the first ablation. a kaplan-meier analysis was used to examine the primary objective. the secondary objectives of this study were to examine whether cardiac rehabilitation following the first ablation for atrial fibrillation had an effect on the evolution of the patients' bmi (a mann-whitney u test), the number of recurrences of atrial fibrillation (a poisson regression) and the proportion of patients who need to continue treatment with antiarrhythmics 3 months following the first ablation (a chi-square test).

the intervention group follows a 3 months rehab program consisting of training, education, coaching and medical follow-up. the control group are patients that chose not to follow this program. this is a retrospective non randomized trial

Eligibility criteria:
inclusion criteria: * an ablation for af (atrial fibrillation) exclusion criteria: * a complicated ablation * a prosthetic heart valve * a severe valvulopathy, * hyperthyroidism at the time of the ablation, * pregnancy and breastfeeding, * intensive sport (more than 1 hour a day), * a myocardial infarction or a thromboembolic event within 3 months after the ablation, * a pacemaker * end-stage renal disease.
comparison of spencer technique and isotonic exercise in patients with adhesive capsulitis

Conditions: Adhesive Capsulitis, Shoulder

Summary: this study examines the efficacy of two forms of therapy for adhesive capsulitis, a condition characterized by stiffness, pain, and limited mobility in the shoulder joint. it is also commonly known as "frozen shoulder".

patients between the ages of 30 and 55 were randomly assigned to one of two groups for the trial held at the saleem free hospital okara and dar-ul-shifa hospital. group 2 engaged in isotonic exercises that emphasized concentric and eccentric motions of forward flexion and extension, whereas group 1 was given the spencer approach, which involved seven different movements. a goniometer and the numeric pain rating scale were used to measure the range of motion and pain. spss 20 was used to analyze the data and assess how well the treatments worked. the findings provided light on how well manual therapy and exercise compare in terms of reducing pain and increasing shoulder movement in people with adhesive capsulitis.

Eligibility criteria:
inclusion criteria * both genders aged 30-55 years * unilateral adhesive capsulitis * pain lasting for more than one month * capsular pattern of motion restriction * diabetic patients were included. exclusion criteria * participants with rotator cuff tear * rheumatoid and gouty arthritis * tumors of the shoulder region * peripheral nerve injuries * shoulder girdle fracture and dislocation * history of shoulder surgery were excluded.
all-inside single-bundle for anterior cruciate ligament reconstruction with full thickness of the peroneus longus tendon compared to the six-strand-hamstring autograft (acl)

Conditions: Anterior Cruciate Ligament Injuries

Summary: anterior cruciate ligament reconstruction is the current gold standard for restoring knee stability. hamstring tendon (ht) autograft is the most popular graft choice for acl reconstruction worldwide. other autografts include bone-patellar tendon-bone and quadriceps tendon, yet no globally accepted gold standard of graft choice exists for use in acl reconstruction. the peroneus longus tendon (plt) has been reported as an autograft choice for ligament reconstruction\[2\], but there is little information regarding the clinical outcomes using the peroneus longus tendon (ahplt) compared with hamstring tendon autograft. therefore, we are interested in investigating whether the clinical outcomes of the plt autograft were equivalent to the six-strand- hamstring tendon autograft.

prospective randomized clinical study to compare the results of all-inside anatomical acl reconstruction using the ahplt and using six-strand- tendon autograft. randomization will be done with inclusion criteria of primary acl rupture in adult patients and exclusion criteria of serious osteoarthritis, revision cases, and multiple ligament injuries. preoperatively, physical examinations including the anterior drawer test and the pivot shift test were performed to judge the stability of the knee joint. all of the patients will be evaluated with an international knee documentation committee (ikdc) 2000 subjective score, a visual analogue scale (vas), and an american orthopedic foot and ankle score (aofas).a knee joint arthrometers was also used with knee flexion of 30° at 134 n. all of the tests will be performed three times by another experienced orthopedic surgeon who is not involved in the surgery, and the mean of the three measurements will be taken as the final value.

Eligibility criteria:
inclusion criteria: * primary acl rupture in adult patients exclusion criteria: * serious osteoarthritis * revision cases * multiple ligament injuries * ankle injuries

Keywords: anterior cruciate ligament peroneus longus tendon hamstring tendons donor site