Kornimate/medical-research-clean huggingface dataset:
anterior cruciate ligament reconstruction using single bundle and double bundle techniques

Conditions: Anterior Cruciate Ligament Injury

Summary: anterior cruciate ligament (acl) reconstruction surgery has greatly advanced over the last 20 years. however, data in the literature reveal that approximately 15-25% of patients undergoing surgery still do not present optimal outcomes, which suggests that there is room for improvement of the procedure. a possible explanation for this fact is that most acl reconstructions consider only one of the functional bundles of the ligament. our hypothesis is that the acl reconstruction with the double-bundle technique will be effective in reducing the patients' rotation of the knee joint for high-demanding tasks compared to the patients who had acl reconstruction with the single-bundle technique.

the aim of this study is to compare the acl reconstruction with only one bundle (one tunnel in the tibia and femur) with the procedure to reconstruct the the acl with two bundles with 2 tunnels in the tibia and 2 in the femur (considered closest to the normal anatomy of of the acl), both in terms of objective and subjective results.

Eligibility criteria:
inclusion criteria: 1. male or female. 2. body mass index (bmi), which corresponds to the ratio between weight in kilograms (pounds) and height in m2 (square meters) between 18.5 and 24.99. 3. anterior instability alone or associated with chondral lesions of up to 1cm or associated with meniscal injuries that do not alter the postoperative rehabilitation. 4. magnetic resonance imaging (mri) confirming the acl injury. 5. aged between 20 and 45 years. 6. not having asymmetric varus alignment, greater than or equal to 5 degrees (to eliminate cases with indication for osteotomy of the tibia), using panoramic radiographic comparison of the lower limbs in standing position. 7. absence of associated ligament instabilities (medial, lateral or posterior). 8. no previous surgery on the affected knee. exclusion criteria: 1. new post-surgical trauma after 12 months. 2. interruption of treatment / follow-up. 3. postoperative infection.
safety and efficacy of proellex in pre-menopausal anemic women with symptomatic uterine fibroids

Conditions: Uterine Fibroids; Anemia

Summary: subjects will be randomly assigned to one of 3 treatment groups and receive 325 mg (65 mg elemental iron) iron supplements twice daily.

eligible female subjects will be randomly assigned to one of the three treatment groups. subjects will receive 325 mg (65 mg elemental iron) iron supplements to be taken twice daily during study drug treatment. the study duration is approximately six months, which is comprised of a 4 - 6 week screening period, a three-month drug treatment period, and a one-month follow-up period.

Eligibility criteria:
inclusion criteria: * female, between the ages of 18 and 48 years with body mass index (bmi) between 18 and 39, inclusive; * anemic, defined as hemoglobin levels less than or equal to 10.5 g/dl and uterine fibroid-associated symptoms indicated by a history of excessive menstrual bleeding; * surgical interventions for uterine fibroids (e.g. hysterectomy or myomectomy) planned or anticipated after the study; * willing to comply with all study procedures, including the endometrial biopsies and blood draws for all visits, including follow-up visits exclusion criteria: * post-menopausal women or women likely to become post-menopausal during the study, defined as one or more of the following: * six months or more (immediately prior to screening visit) without a menstrual period, or * prior hysterectomy, or * prior bilateral oophorectomy (unilateral oophorectomy is not exclusionary if regular menstruation is occurring); * females who have undergone a uterine arterial embolization, or endometrial ablation therapy (previous myomectomy is acceptable) for any cause; * documented endometriosis or active pelvic inflammatory disease (pid); * having a diagnosis, or suspected diagnosis, of carcinoma of the breast or reproductive organs; * known active infection with hiv, hepatitis a, b or c, gonorrhea, or chlamydia; * use of prohibited concomitant medications: 1. depo-provera use must cease ten months prior to first dose of study drug, or 2. gnrh agonists use (e.g. lupron depot) must cease six months prior to first dose of study drug, or 3. oral contraceptive or other hormonal treatments use must cease for 30 days prior to the start of the study

Keywords: uterine fibroids anemia
national survey on hypertension in general practitioner (gp) consultation

Conditions: Hypertension

Summary: to evaluate (with sufficient accuracy) the profile(demographic and clinical characteristics, health care management) of hypertensive patients seen in general practitioner consultation.


Eligibility criteria:
inclusion criteria: * male or female \> or = 18 years old * known hypertension * agree to take part in this study exclusion criteria: * none

Keywords: hypertension general practitioner consultation patients with hypertension
efficacy and safety of ledipasvir/sofosbuvir fixed-dose combination for 12 weeks in subjects with chronic genotype 1 or 4 hcv and hiv-1 co-infection

Conditions: Hepatitis C Virus; HIV

Summary: this study will evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (ldv/sof) fixed-dose combination (fdc) administered for 12 weeks in hepatitis c virus (hcv) treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic genotype 1 or 4 hcv infection who are co-infected with hiv-1. participants who experience confirmed post-treatment virologic failure (relapse) at or before posttreatment week 24 may be eligible to be enrolled in the retreatment substudy to receive ldv/sof plus ribavirin (rbv) for 24 weeks.


Eligibility criteria:
inclusion criteria: * hcv rna ≥ 10,000 iu/ml at screening * hcv genotype 1 or 4 * hiv-1 infection * cirrhosis determination, a fibroscan or liver biopsy may be required * screening laboratory values within defined thresholds * use of protocol specified method(s) of contraception if female of childbearing potential or sexually active male exclusion criteria: * clinically-significant illness (other than hcv or hiv) or any other major medical disorder that may interfere with subject treatment, assessment, or compliance with the protocol * current or prior history of clinical hepatic decompensation, hepatocellular carcinoma (hcc), or other malignancy (with the exception of certain resolved skin cancers) * hepatitis b virus (hbv) infection * pregnant or nursing female * chronic use of systemically administered immunosuppressive agents

Keywords: genotype 1 genotype 4 hiv
malnutrition in chronic pancreatitis, trans-sectoral study

Conditions: Chronic Pancreatitis; Malnutrition; Sarcopenia

Summary: malnutrition and loss of muscle mass are common in patients with chronic pancreatitis. however, there is only limited data on nutritional treatment. in this study, malnourished patients with chronic pancreatitis will receive an intensified nutritional therapy to improve nutritional status. the aim of the study is that malnutrition in patients with chronic pancreatitis can be successfully treated.

malnutrition and sarcopenia are common complications in chronic pancreatitis leading to increased morbidity and mortality. therefore nutritional therapy can be considered imperative. however, there is limited evidence on the treatment of malnutrition in patients with chronic pancreatitis. this study aims to investigate the effect of an intensified nutritional therapy on nutritional status in malnourished patients with chronic pancreatitis. by testing feasibility of this intensified therapy valuable recommendations for future treatment of malnutrition in patients with chronic pancreatitis can be derived.

Eligibility criteria:
inclusion criteria: * chronic pancreatitis verified by histology or imaging modality (endoscopic ultrasound, computed tomography, magnetic resonance imaging, magnetic resonance cholangiopancreatography) * diagnosis of malnutrition exclusion criteria: * pregnant or breast feeding * implanted defibrillator or pacemaker * history of pancreatic cancer * any other malignant tumor disease within the last 3 years * concomitant liver cirrhosis
prescription pattern of adjuvant drugs and vitamins in patients undergoing long-term home nutritional support for intestinal insufficiency

Conditions: Intestinal Insufficiency; Short Bowel Syndrome

Summary: intestinal insufficiency due to short bowel syndrome is a chronic, disabling condition with significant morbidity and mortality.standard care includes home parenteral/enteral nutrition as well as intestinal transplantation, however multiple drugs, vitamins, antibiotics and symptom-relieving agents may be required. prescriptional pattern of these drugs will be analyzed in a clinical cohort.

intestinal insufficiency due to short bowel syndrome is a chronic, disabling condition with significant morbidity and mortality.standard care includes home parenteral/enteral nutrition as well as intestinal transplantation, however multiple drugs, vitamins, antibiotics and symptom-relieving agents may be required. little attention has been given to the indications and dosage schedules of such drugs, many of which are employed as off-label prescriptions because of lack of official guidelines. prescriptional patterns of these drugs will be analyzed in a clinical cohort of home parenteral/enteral nutrition patients, registered at the outpatient service of hospital das clinicas, sao paulo, brazil.

Eligibility criteria:
inclusion criteria: home nutritional support longer than 12 months,full records and return visits available at the hospital system. - exclusion criteria: critical illness, death, discontinuation of nutritional therapy, registered for intestinal transplantation, additional gastrointestinal operations for short bowel syndrome (valves, lengthening) or for other conditions (gallbladder disease, intestinal obstruction, necrosis, infection). -

Keywords: gastrointestinal drugs antibiotics vitamins minerals intestinal insufficiency short bowel syndrome adjuvant therapy antacids gastrointestinal motility modifiers micronutrients
aesthetic performance of "profhilo®" injective intradermal treatment for the neck

Conditions: Skin Manifestations

Summary: the objective of this study is to investigate the aesthetic performance of the hyaluronic acid (ha)-based dermal filler profhilo® injected by a novel bio aesthetic point technique ("bap" techinique ) in woman aged 40-65 years with skin flaccidity and roughness of the neck.


Eligibility criteria:
inclusion criteria: * female sex, * 40-65 years, * 3-4 neck roughness/laxity grade according to a clinical reference scale; * asking for neck laxity and roughness restoration; * available and able to return to the study site for the post-procedural follow-up examinations; * accepting to not change their habits regarding food, physical activity, cosmetic and cleansing products for the neck; * accepting to not expose their neck to strong uv irradiation (uv session, or sun bathes) during the entire duration of the study, without appropriate sun protection; * accepting to sign the informed consent form. exclusion criteria: * pregnancy; * lactation; * smokers; * alcohol abuse and/or drug use; * subjects not in menopause who do not use adequate contraceptive precautions in order to avoid pregnancies during the study; * subjects not in menopause who do not accept to perform the pregnancy test at t0 (before the 1st aesthetic procedure) and at t1 (1 month after the 1st injection treatment execution, before the 2nd aesthetic procedure); * body mass index (bmi) variation (± 1) during the study period; * performing skin treatments for neck aesthetic correction (biomaterials implants, neck lifting, botox injections, laser, chemical peeling) in the 6 months prior to the study start; * performing permanent filler in the past; * change in the normal habits regarding food, physical activity, neck cosmetic and cleansing use during the month preceding the test; * sensitivity to the test product or its ingredients (to be assessed by the investigator during the baseline visit); * subjects whose insufficient adhesion to the study protocol is foreseeable; * participation in a similar study currently or during the previous 9 months; * dermatitis; * presence of cutaneous disease on the tested area, as lesions, scars, malformations; * recurrent facial/labial herpes; * clinical and significant skin condition on the test area (e.g. active eczema, psoriasis, severe rosacea, scleroderma, local infections and severe acne); * diabetes; * endocrine disease; * hepatic disorder; * renal disorder; * cardiac disorder; * pulmonary disease; * cancer; * neurological or psychological disease; * inflammatory/immunosuppressive disease; * drug allergy; * anticoagulants and antiplatelet drugs, anti-histaminic, topic and systemic corticosteroids, narcotic, antidepressant, immunosuppressive drugs (with the except of contraceptive or hormonal treatment starting more than 1 year ago); * using of drugs able to influence the test results in the investigator opinion.
photobiomodulation therapy in the prevention and management of radiotherapy-induced vaginal toxicity

Conditions: Radiotherapy Side Effect; Vaginal Abnormality

Summary: this study aims to investigate the effectiveness of photobiomodulation therapy (pbmt) in the prevention and management of radiotherapy-induced vaginal toxicity (rivt). therefore, we hypothesize that pbmt can reduce the severity of rivt in gynecological cancer patients, increasing the patient's qol and sexual functioning.

the global cancer burden keeps rising, and the accompanied side effects remain a significant concern. this project focuses on one of such complications: radiotherapy-induced vaginal toxicity (rivt). the use of external and internal radiotherapy in gynecological cancers can severely impact the patient's vaginal function. this influences the patient's quality of life (qol), as it significantly limits sexual intercourse and further physical examination. management of rivt urgently requires a comprehensive approach. photobiomodulation therapy (pbmt) is a non-invasive form of phototherapy that utilizes visible and/or near-infrared light to trigger a cascade of intracellular reactions. pbmt can be used to improve wound healing, and to reduce pain, inflammation, and edema. literature shows that pbmt can be used for treating the genitourinary syndrome of menopause as it stimulates the synthesis of collagen and elastin and promotes vasodilation in the vaginal submucosa. to date, no clinical trials have investigated the positive effects of pbmt on rivt.

Eligibility criteria:
inclusion criteria: * diagnosed with endometrial cancer * scheduled for external beam radiotherapy (ebrt), intracavitary brachytherapy (bt), or a combination * age ≥ 18 years * able to comply to the study protocol * able to sign written informed consent exclusion criteria: * metastatic disease * pregnancy * diagnosis of vaginal stenosis before radiotherapy (rt) * previous pelvic tumor or pelvic rt * interruption of rt for more than five sessions * severe psychological disorder or dementia. * inability to speak and understand dutch * substance abuse patients or patients with medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results as judged by the investigator * any condition that is unstable or could affect the safety of the patient and their compliance in the study as judged by the investigator

Keywords: photobiomodulation therapy
eccentric cycling exercise during pulmonary rehabilitation pulmonary vascular disease

Conditions: Eccentric Cycling Exercise

Summary: eccentric cycling allows high intensities with low metabolic costs. therefore the aim of this project is to investigate whether ecc improves exercise capacity and possibly hemodynamics during prolonged rehabilitation programs in patients with pvd

eccentric cycling exercise (ecc) allows training at low metabolic costs and may therefore be valuable for patients with pulmonary vascular disease (pvd). for these patients, regular exercise training has an evidence level 1a recommendation in the current guidelines. exercise training during longer and regular periods provides chronic adaptation, for which ecc was recently found to have a greater effectiveness than con by increasing muscle strength, hypertrophy, six-minute walking distance and furthermore, by increasing maximum oxygen uptake (v'o2max) especially in patients with chronic obstructive pulmonary disease (copd), chronic left heart failure or coronary heart disease. furthermore, the investigators conducted an rct in which the investigators exposed patients with pvd to ecc and concluded that ecc is a feasible and well-tolerated exercise modality for pvd patients with severely lower o2 demand and load to the right ventricle. therefore the aim of this project is to investigate whether ecc improves exercise capacity and possibly hemodynamics during prolonged rehabilitation programs in patients with pvd.

Eligibility criteria:
inclusion criteria: * diagnosed with pvd, either pah or cteph according to recent guidelines * stable medication for at least 1 month * age 18 to 85 years * no resting hypoxemia (pao2 \>7.3kpa) exclusion criteria: * any co-morbidity that limits the patient to participate the full rehabilitation * enrollments in other trials with active treatments
mindful moms randomized control trial

Conditions: Depression

Summary: the purpose of this study is to test whether a program called "mindful moms" can be helpful for specific measures of mood and health in pregnant women with depressive symptoms, compared to group-based education workshops.

the mindful moms study is a randomized controlled trial, in which participants will be randomly assigned (like the flip of a coin) to either the "mindful moms" group (12 weeks of group-based prenatal yoga) or the "prenatal education circle" group (12 weeks of group-based prenatal education). 200 pregnant women will participate over the course of the study.

Eligibility criteria:
inclusion criteria: 1. pregnant woman at 12-26 weeks gestation at baseline visit; 2. defined as minority (e.g., black/ african american, hispanic/ latino, native american, etc) and/or annual household income at qualification level for women, infants, \& children \[wic\] benefits in virginia and/or educational attainment ≤high school education; 3. ≥age 18; 4. current depressive symptoms, as defined by a score ≥7 on the edinburgh postnatal depression scale (epds); 5. able to read, write, and understand english; 6. has not been told by a healthcare provider to avoid physical activity; 7. has not engaged in a consistent (once/week or more) yoga-based practice during the current pregnancy. exclusion criteria: does not meet the inclusion criteria above.

Keywords: pregnancy
a rct for y-knot all-suture anchor in ankle ligaments injury repair

Conditions: Ligament Injury

Summary: purpose of this study is to evaluate the effectiveness and safety of y-knot all-suture anchor by comparing patients' clinical outcome after ankle ligaments repair surgery.


Eligibility criteria:
inclusion criteria: * male or female, no less than 18 years old; * patient was diagnosed as collateral ligament injury or achilles tendon injury based on mri or x-ray who need to conduct foot\&ankle repair surgery by investigator; * patient willing to sign a written consent form participating in this study； * subject is able to understand study, willing to comply the study procedures, and willing to return to hospital for follow-up up to 6 months postoperative； * life expectancy is more than 2 years post-operationally; exclusion criteria: * conducted surgery at index ankle and possibly influence the outcome evaluation; * bilateral ankle surgery; * suffering concurrent ankle disease that may leads to a surgery during the study phase; * known or suspected allergies to implant and/or instrument materials; * pathological conditions of bone which would adversely affect the anchor fixation; with concurrent severe injury at index leg that may influence the outcome evaluation; severe obesity; * with concurrent disease that may influence the index ankle function; * patients with active sepsis or infection; * with concurrent disease that may influence the stability of device and rehabilitation; * immune suppression, impairment of immune function, or autoimmune disease; * pregnant or lactating women; * known noncompliance or lost follow-up risk; * participated other drug, biologic, or device clinical trial 12 months before enrollment; * alcohol or drug abuser; * other inappropriate condition based on investigator determination;
improving antibiotic prescribing for urinary tract infections in frail elderly

Conditions: Urinary Tract Infections

Summary: the purpose of this study is to determine whether a tailored multifaceted antibiotic stewardship intervention reduces antibiotic use for urinary tract infections in residential care homes and nursing homes attended by general practitioners. this will be evaluated in a pragmatic cluster randomised controlled trial using a modified community-based participatory action research approach.

rationale: almost 60% of antibiotics in frail elderly is prescribed for alleged uti. about half of the antibiotics for uti in this population are prescribed for non-specific signs and symptoms; a substantial part of these prescriptions might not be necessary. research question: does a tailored multifaceted antibiotic stewardship intervention reduce antibiotic use for uti in residential care homes and nursing homes attended by general practitioners (gps)? study design, setting and population: a pragmatic cluster randomised controlled trial using a modified community-based participatory action research approach. in the intervention group the latest uti guidelines (which are standard care) are actively implemented at the level of the gp/caregivers. residents ≥ 70 year with adl dependency from 34 care homes + attending gp practices will participate in norway, sweden, poland and the netherlands. methods: the study has two measurement periods; a baseline period (5 months) and a follow-up period (7 months). in between the antibiotic stewardship intervention will be tailored and implemented in intervention practices. gps will prospectively register suspected utis on standardized registration forms and (study) nurses/assistants will follow-up patients at day 7 and day 21 for each uti. patients will be enrolled prior to the start of the study. * june-august 2019: patient are recruited, informed consent is obtained, baseline characteristics of patients are recorded * sept 2019: study starts (from this moment onwards, the outcomes are being assessed). data analysis: the primary analysis will be to assess the number of prescriptions of antibiotics for suspected uti in the follow-up period, correcting for the baseline period and controlled for pre-specified confounders, using a generalized linear mixed model for poisson distributions.

Eligibility criteria:
inclusion criteria: * physical and/or mental disabilities and adl dependency requiring residential care or nursing home care * attended by general practitioners * not on continuous prophylactic antibiotic use exclusion criteria: * in hospice-care * very limited life expectancy (≤1 month) * no longer wish to participate * start continuous antibiotic (prophylaxis) * die or move away from the residential care home / nursing home if patients are excluded within 2 months after inclusion, they will be taken out of the study. in other words: patients need to be included for at least 2 months to contribute data to the study.

Keywords: cluster randomized trial antibiotic stewardship frail elderly