Kornimate/medical-research-clean huggingface dataset:
high tibial osteotomy (hto) with or without arthroscopy of the knee joint

Conditions: Medial Compartment Osteoarthritis of the Knee

Summary: participants will be randomized to undergo a high tibial osteotomy (hto) with or without a knee scope. patients will be tested in the gait lab, will fill out quality-of-life questionnaires, and have a clinical evaluation done preoperative and at each follow-up visit.


Eligibility criteria:
inclusion criteria: * all patients booked for an hto due to oa * grades ii to iv severity of oa by radiographic evaluation (kellgren \& lawrence grade) * oa of the knee primarily involving the medial compartment exclusion criteria: * imaging evidence of significant knee joint pathology that would change the decision to do an hto * an arthroscopy of the knee within 2 years of planned surgery * active joint or systemic infection, * major medical illness that would preclude undergoing surgery, * patients who are unwilling or unable to be assessed according to study protocol for two years following surgery * major psychiatric illness, developmental handicap or inability to read and understand the english language

Keywords: hto arthroscopy quality-of-life gait analysis
pranayama for posttraumatic stress disorder

Conditions: Post Traumatic Stress Disorder

Summary: this study aims to investigate the effect of pranayama (yoga-breathing techniques) on post-traumatic symptom severity in patients with post-traumatic stress disorder undergoing standard, out-patient, trauma-focused psychotherapy. therefore, short pranayama sessions of 5-10 minutes will be provided to the patients directly at the begin of each of psychotherapy unit, while the control group will receive standard, trauma-focused psychotherapy alone.


Eligibility criteria:
inclusion criteria: * diagnosed ptsd according to icd-10 f43.1 * pcl-5 score of at least 33 points * undergoing outpatient standard trauma-focused psychotherapy (cognitive behavioral therapy, psychodynamic psychotherapy, or systemic psychotherapy) exclusion criteria: * pre-existing mental or somatic conditions that are unlikely to result in correct or safe performance of pranayama: 1. substance dependence current use (icd-10 f10.x, f11.x). 2. dementia (icd-10 f00-f03) 3. somatoform disorder (icd f45.x) of moderate or severe degree according to dsm-5 300.82: ≥ 2 reactions (cognitive, emotional, or behavioral) to somatic symptoms (≥ 2 criterion-b) 4. severe cardiovascular disease: presence of cardiac or vascular implants or grafts, e.g., pacemaker (icd-10 z95.x), condition after organ or tissue transplantation (icd-10 z94.x) 5. acute adverse events occurring during pranayama at baseline (including neck pain, subjective sensation of pressure in the lungs, anxiety / panic) * cancer diagnosis in the past 5 years (icd-10 c00-c97, d37-48) * pregnancy / breastfeeding * regular pranayama practice in the last 12 months

Keywords: posttraumatic stress disorder pranayama yoga complimentary therapies somatic symptom disorder ssd ptsd safety effectiveness randomized controlled trail
safety and modulation of adaptive immunity by iscador® qu viscum album extract in patients with advanced, recurrent or metastatic cancers treated with immune checkpoint inhibitors

Conditions: Advanced Solid Tumor

Summary: the main objective of this study is to test if adding the mistletoe extract iscador® qu to regular cancer treatment with immune checkpoint inhibitors affects: * the immune system's ability to fight cancer * safety of the treatment * how well the treatment performs against cancer * how the patient feels during treatment researchers will compare patients treated with immune checkpoint inhibitors plus iscador® qu with patients treated with imune checkpoint inhibitors only.

the impact of mistletoe preparations - that are claimed to have immunostimulatory properties - on cancer treatment with immune checkpoint inhibitors remains unclear. to address this knowledge gap, the current study aims to investigate the modulation of adaptive immunity through the combination of iscador (a specific mistletoe preparation) and immune checkpoint inhibitors. additionally, researchers will evaluate the safety profile of this combination therapy in patients with locally advanced non-operable or metastatic cancers except for skin cancers. by examining the modulation of adaptive immunity and safety of this treatment approach, researchers aim to provide valuable insights for clinicians and patients in the context of advanced cancer care.

Eligibility criteria:
inclusion criteria: * locally advanced non-operable or metastatic solid tumor, except for skin cancer * eligible for routine (standard) treatment with immune checkpoint inhibitor (+/- chemo/targeted therapy) as per the discretion of the local investigator * subjects must be eligible for treatment with mistletoe preparations (controlled brain metastases, prednisolone equivalent below 10mg, no known hypersensitivity) * ecog (eastern cooperative oncology group) performance status score of 0-2 * males and females at least 18 years of age; no subjects under tutelage * no previous mistletoe treatment exclusion criteria: * contraindications to iscador® qu or immune checkpoint inhibitors, e.g. hypersensitivity, active autoimmune disorder * patients with skin cancer * participation in another study with investigational drug within 30 days prior to enrolment (participation in observational studies or diagnostic studies without a particular drug intervention are allowed) * enrolment of the investigator, his/her family members, employees and other dependent

Keywords: mistletoe extract
automated lamellar keratectomy in symptomatic patients with bullous keratopathy

Conditions: Corneal Disease

Summary: to relieve pain in patients with symptomatic bullous keratopathy (bk) until keratoplasty and in patients without visual prediction. the automated lamellar keratectomy represents a alternative in treatment of pain in symptomatic patients with bk.

only patients with bk symptomatic (with pain) were submitted to automated lamellar keratectomy (alk). complete ophthalmological examination including ucva,bsva, biomicroscopy, tonometry, esthesiometry, ubm pachymetry, impression cytology and pain questionnaire were performed in preoperative, postoperative of one, seven, 30, 90, 180 days and one year.

Eligibility criteria:
inclusion criteria: * patient with bullous keratopathy symptomatic (with pain) exclusion criteria: * herpetic endotelial disorders

Keywords: cataract extraction surgery corneal disease
games to overcome late life depression

Conditions: Major Depressive Disorder

Summary: this is a pilot study divided into two phases. in phase 1 (completed) participants will be randomized to receive 8 weeks of problem solving therapy (pst) alone or 8 weeks of a cognitive training game called, evolution (evo) plus clinical management. in phase 2 (now recruiting), participants will be randomized to evo, pst, and a different cognitive training program called words. words is similar to evo in that it is an adaptive training program and includes case management. in both studies participants will be assessed for clinical and functional magnetic resonance imaging (fmri) outcomes at baseline, 4 weeks and 8 weeks.

evo is a computer game that targets parts of the brain (i.e. the cognitive control network) that we think may be associated with depressive symptoms. this study is exploratory and will inform future hypotheses the research team will test in subsequent research.

Eligibility criteria:
inclusion criteria: 1. between 60-80 years of age 2. meets criteria for major depressive disorder 3. hamilton depression rating scale (hdrs) of 20 or greater 4. mini mental state exam score of 24 or greater 5. can speak and read english 6. able to physically participate in the research protocol (e.g.: is not suffering from a terminal or highly disabling illness) 7. can participate in mri scans 8. able to provide written informed consent exclusion criteria: 1. history of psychosis, mania, or currently using or abusing illicit drugs or alcohol 2. diagnosis of dementia 3. taking cognitive enhancers 4. change in or newly began taking psychiatric medication within the last 6 months 5. pacemaker 6. metal in the body that cannot be removed 7. color blind 8. movement disorder that prevents participation -

Keywords: depression; mood; cognitive training
postoperative rehabilitation after cardiac surgery in patients at risk of respiratory complications. effects of a continuous bi-laterosternal infusion of ropivacaine through multihole catheters

Conditions: Scheduled Cardiac Surgery; Sternotomy; Elderly Patients; Obesity; Chronic Bronchitis

Summary: postoperative pain after cardiac surgery is a risk factor for postoperative complications. in cardiac surgery, pain is more intense during the first 48 hours and disturbs the patient's capacity of coughing, deep breathing, and early mobilisation. it may be responsible for respiratory complications such as bronchial or pulmonary infection, and may also delay the patient's rehabilitation and therefore prolong the duration of in-hospital stay. a previous pilot study performed in our department showed a sensible improvement of analgesia at movement and of rehabilitation with a continuous bilaterosternal infusion of local anaesthesia \[eljezi et al.. reg anesth pain med 2012; 37:166\]. such strategy shall be tested in a subpopulation of patients at risk for respiratory complication.

prospective, controlled, randomised, parallel, single-centre, single-blinded trial, comparing to a control (conventional care with no locoregional anaesthesia) an infusion of ropivacaine through two multihole catheters placed lateral to the sternum. in both groups, postoperative analgesia will be achieved by paracetamol plus titrated then self-administered intravenous morphine.

Eligibility criteria:
inclusion criteria: * scheduled cardiac surgery (aortic or mitral valve replacement, or coronary bypass surgery) with sternotomy. * patients will be at risk of noncardiac postoperative complications, i.e. age over 75, bmi over 30, pulmonary disease, or active smoking habit exclusion criteria: * surgery in emergency * thoracotomy * cardiac graft * redo * aortic dissection * age over 85 * pregnancy * patient's refusal * minor or adult under legal protection * psychiatric ongoing disease * addiction to opiates * ongoing opiate treatment * inability to use a pca device * respiratory insufficiency (vital capacity or maximal expired volume per sec. \ 50 mmhg) * cardiac failure or ef \< 40% or intra-aortic balloon use * pulmonary hypertension over 50 mmhg * severe renal insufficiency * history of allergy or intolerance to: morphine, acetaminophen, ropivacaine.

Keywords: sternotomy anesthesia post-operative pain
evolution of symptoms after anterior sacrospinofixation by autologous tissues

Conditions: Pelvic Organ Prolapse

Summary: prolapse is a pathology that can cause pelvic, urinary or sexual functional disorders and impaired quality of life. although the use of vaginal mesh is a commonly practiced technique to correct prolapse, in recent years health officials have pointed to the lack of adequate safety and tolerability assessments of these implants. currently, surgeons are therefore moving towards techniques without implants. the standard vaginal technique for the treatment of uterine prolapse is sacrospinofixation according to richter. this technique can be performed without an implant, using autologous tissue. functional discomfort of patients is the main problem linked to the presence of prolapse. however, no study has yet evaluated the feelings of patients following the use of this sacrospinofixation technique by autologous tissues by vaginal route, which led us to set up this study. the hypothesis is that the technique of anterior sacrospinofixation by autologous tissues improves the symptoms experienced by patients with an mid-level and / or anterior genital prolapse.


Eligibility criteria:
inclusion criteria: * women over 18 * middle and / or anterior genital prolapse (hysterocele and / or cystocele) requiring surgical correction of stage ≥ ii in the pop-q classification * patients wanting an intervention because of the discomfort caused by the prolapse * intervention planned by anterior sacrospinofixation by autologous tissues * person having expressed his non-opposition exclusion criteria: * prolapse of stage \< ii in the pop-q classification, or prolapse without functional impairment * disorders involving an unacceptable risk of postoperative complications sought after questioning of the patient (blood coagulation disorders, immune system disorders, progressive diseases, etc.) * reduced mobility of the lower limbs (not allowing positioning for surgery) * pregnancy or any pregnancy plan for the duration of the study * active or latent infection * inability to understand the information given * person deprived of liberty, under guardianship.

Keywords: middle anterior prolapse ≥ ii (pop-q classification) anterior prolapse ≥ ii (pop-q classification)
a study of edp-514 in patients with chronic hepatitis b virus infection who are not currently on treatment

Conditions: Chronic HBV Infection

Summary: this is a randomized, double-blind, placebo-controlled study in viremic chronic hepatitis b subjects, assessing the safety, tolerability, pharmacokinetics and antiviral activity of 28 days treatment with edp-514.

the study assesses multiple ascending doses of edp-514 compared to placebo for 28 days in viremic chronic chb-infected subjects not currently on treatment. each cohort will enroll a total of 8 subjects who will be randomized to receive edp-514 or placebo.

Eligibility criteria:
inclusion criteria: * an informed consent document signed and dated by the subject. * healthy male and female subjects of any ethnic origin between the ages of 18 and 70 years, inclusive * hbv dna levels: * for subjects who are hbeag positive at screening, a screening hbv dna level in serum/plasma that is ≥20,000 iu/ml, or * for subjects who are hbeag negative at screening, a screening hbv dna level in serum/plasma that is ≥2,000 iu/ml, and * for all subjects, no hbv dna serum/plasma test values \<1,000 iu/ml over the previous 12 months (using an approved test) * chb subjects must not have been on prescribed anti-hbv treatment for at least 12 months prior to screening exclusion criteria: * a documented prior diagnosis of cirrhosis * pregnant or nursing females * coinfection with human immunodeficiency virus (hiv), hcv, hdv, hav, or hev * chronic liver disease of a non-hbv etiology; coexisting liver or biliary diseases

Keywords: multiple ascending dose hepatitis b virus hbv
comparison of radical prostatectomy performed by robot-assisted laparoscopy or conventional laparoscopy or by laparotomy

Conditions: Prostate Cancer

Summary: minimally invasive surgery has developed widely since the 1980s and has revolutionized the practices of surgeons. in urology, the development of laparoscopy and then robot-assisted surgery has considerably improved the management of pathologies. in france, as in all the countries concerned, the spread of robotic surgery has taken place without prior studies validating this new technology, nor organizational rules in terms of quality and access to care. the report of the haute autorité de santé dated november 2016 underlines the weakness of the methodological quality of studies and meta-analyzes evaluating robot-assisted total prostatectomy compared to other surgical techniques by laparotomy or conventional laparoscopy. it therefore appears important to evaluate in a large study the interest of this technique in order to help the authorities to decide on the real benefit of this technology and to provide reliable answers to the patients.

minimally invasive surgery has developed widely since the 1980s and has revolutionized the practices of surgeons. in urology, the development of laparoscopy and then robot-assisted surgery has considerably improved the management of pathologies. in france, as in all the countries concerned, the spread of robotic surgery has taken place without prior studies validating this new technology, nor organizational rules in terms of quality and access to care. the report of the haute autorité de santé dated november 2016 underlines the weakness of the methodological quality of studies and meta-analyzes evaluating robot-assisted total prostatectomy compared to other surgical techniques by laparotomy or conventional laparoscopy. it therefore appears important to evaluate in a large study the interest of this technique in order to help the authorities to decide on the real benefit of this technology and to provide reliable answers to the patients.

Eligibility criteria:
inclusion criteria: * patient hospitalized for a planned radical prostatectomy exclusion criteria: * consent refusal from the patient * patients protected by law (art.l 1121-5, 1121-6, 1121-8 du code de la santé publique) * absence of a french health care insurance coverage

Keywords: robot-assisted laparoscopy laparotomy conventional laparoscopy prostatectomy
molecular characterisation of appendiceal cancer

Conditions: Appendiceal Cancer

Summary: patients ≥ 18 years old who have been diagnosed with appendiceal cancer with peritoneal metastases, have had cytoreductive surgery, have availability of archival tumour tissue and have consented to our institutional biobank program or have a waiver of consent for deceased patients who have not had the opportunity to provide biobank consent (requested at the time of ethics review). descriptive analysis of the proportion of genetic mutations identified in appendiceal cancers. this is given by the percentage of pathogenic mutations in the peritoneal metastasis compared to the primary tumour.

appendiceal cancer is a rare and understudied cancer that frequently leads to metastatic disease with production of copious gelatinous collections in the abdomen, causing severe illness and poor survival. the only definitive treatment available is a complex and aggressive surgical procedure involving removal of organs and the internal lining of the abdomen. there is an urgent need to define clinical predictors of survival, the role of chemotherapy and to develop new treatments. the genetics of appendiceal cancer has been reported in small cohorts of patients but there has been limited research on how mutations affect treatments or survival. there is no information on how and why primary appendiceal cancers often spread just to the lining of the abdomen. understanding how genetic mutations evolve in the tumours are important for working out treatments to prevent the spread of cancer. current high throughput laboratory techniques for analysing the genetic makeup of appendiceal cancer has the power to identify mutation patterns than might predict for treatments and survival outcomes. this study proposes completing tumour genetic studies on archived cancer tissue removed routinely from patients who previously have had surgery for their appendiceal tumour. the results of genetic tests can then be compared to clinical characteristics of the patients such as survival time and treatments received. genes in primary appendix tumours can be compared to those in tumours that have spread into the lining of the abdomen to describe what changes if any occur during the spreading process. this study will help make progress towards better and personalised treatment options, identifying predictors of treatment success and long-term survival. improved treatments and better selection of patients may ultimately improve quality of life and help patients live longer.

Eligibility criteria:
inclusion criteria: participants are eligible to be included in the study only if all of the following criteria apply: 1. patients ≥ 18 years old who have been diagnosed with appendiceal cancer with peritoneal metastases, 2. have had cytoreductive surgery 3. have availability of archival tumour tissue exclusion criteria: * none
recommendations for monitoring clinical experience following implantation of the acrysof® toric

Conditions: Cataract

Summary: to allow surgeons to obtain clinical experience on the postoperative uncorrected and best distance corrected visual acuities (ucva and bdcva) and corneal and refractive cylinder of the acrysof toric iol.


Eligibility criteria:
inclusion criteria: * 40-80 years old; of any race and gender; diagnosed with bilateral cataracts; require cataract extraction followed by implantation of a posterior chamber iol; patients have between 0.75 -2.5 d of astigmatism preoperatively as measured by k readings. exclusion criteria: * females of child bearing potential;irregular corneal astigmatism;keratopathy/keratectasia; cornea inflammation or edema;previous corneal reshaping,dystrophy or transplant;amblyopia;glaucoma;rpe/macular changes;diabetic retinopathy.

Keywords: visual acuity, corneal and refractive cylinder following implantation of the acrysof® toric
a phase 2 study of abbv-3067 alone and in combination with abbv-2222

Conditions: Cystic Fibrosis

Summary: this study will evaluate the safety, tolerability, and efficacy of abbv-3067 given alone and in combination with various doses of abbv-2222 in adults with cystic fibrosis who are homozygous for the f508del mutation.


Eligibility criteria:
inclusion criteria: * confirmed clinical diagnosis of cystic fibrosis (cf) who are homozygous for the f508del cf transmembrane conductance regulator (cftr) mutation * stable pulmonary status * lung function \>= 40 and \<= 90% of predicted normal for age, gender and height at screening exclusion criteria: * history of solid organ or hematopoietic transplant * cirrhosis with portal hypertension * use of cftr modulator therapy within 60 days prior to screening

Keywords: cystic fibrosis abbv-3067 abbv-2222, f508del mutation
clinical efficacy of 10% arginine bicarbonate prophylaxis paste

Conditions: Hypersensitivity

Summary: the objective of this study is to evaluate the clinical efficacy of a prophylaxis paste containing 10% arginine bicarbonate on dentinal hypersensitivity reduction when applied as a pre-procedure to a professional dental cleaning.


Eligibility criteria:
inclusion criteria: * male and female subjects, ages 18-70, inclusive. * availability for the three (3) week duration of the study. * two (2) sensitive teeth, which must be anterior to the molars, and demonstrate cervical erosion/abrasion or gingival recession. * qualifying response to tactile stimuli (yeaple probe) as defined by a score between 10-50gms. of force. * qualifying response to the air blast stimuli as defined by a score of 2 or 3 on the schiff cold air sensitivity scale. * subjects need to satisfy the qualifying response to stimuli for both the parameters assessed (tactile or air) on two teeth to be entered into the study. * good general health with no known allergies to products being tested. * use of a non-desensitizing dentifrice for three months prior to entry into the study. * signed informed consent form. exclusion criteria: * gross oral pathology, chronic disease, or history of allergy to test products. * advanced periodontal disease or treatment for periodontal disease (including surgery) within the past twelve months. * scheduled dental prophylaxis within three weeks prior to the baseline hypersensitivity examination. * sensitive teeth with mobility greater than one. * teeth with extensive/defective restorations (including prosthetic crowns), suspected pulpitis, caries, cracked enamel, or used as abutments for removable partial dentures. * subjects that began to take anticonvulsants, antihistamines, antidepressants, sedatives, tranquilizers, anti-inflammatory drugs, or daily analgesics within one month prior to the start of the study or who have to start taking these during the course of the study. * participation in a desensitizing dentifrice study or regular use of a desensitizing dentifrice within the past three months. * current participation in any other clinical study. * pregnant or lactating subjects. * allergies to oral care products, personal care consumer products, or their ingredients. * medical condition which prohibits not eating/drinking for 4 hours.