Kornimate/medical-research-clean huggingface dataset:
es-hifu, prospective data collection of patients treated with partial gland hifu ablation for prostate cancer

Conditions: Prostate Cancer

Summary: the objective of this study is to evaluate the clinical effectiveness and safety of treatment of prostate cancer in patients who have received a focal hifu treatment using the focal one medical device.


Eligibility criteria:
inclusion criteria: * patient eligible for hifu treatment for prostate cancer, excluding whole gland treatment. * patient newly diagnosed with localized prostate cancer confirmed with an image guided biopsy (mri and/or micro-ultrasounds). * gleason ≤ 4+3. * patient scheduled for hifu treatment as determined by the physician. * patient with healthcare coverage. spanish-speaking patients with the ability to provide informed written consent exclusion criteria: * patient with bilateral prostate cancer requiring whole gland treatment. * patients clinically detected metastasis. * patient with an extension of cancer or seminal vesicle invasion. * patient with contraindications for hifu treatment: please refer to the complete focal one user manual.
observation of the clinical efficacy of two surgical procedures for varus knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: the purpose of this study is to conduct a prospective randomized controlled trial to compare the effects between two surgical procedures in the treatment of varus knee osteoarthritis.the hypothesis was that there would be no difference in mechanical axis correction between two surgical procedures.

this was a single-center, prospective, double-blinded, randomized controlled trial, comparing two surgical procedures in the treatment of varus knee osteoarthritis. participants were recruited from september 2019 to september 2021. before initiating the trial, an investigator who was not involved in the study generated a computer-generated randomization list (block length 10, ratio 1:1). allocation concealment was achieved by using opaque, sealed, sequentially numbered envelopes containing details of group assignment. assignment occurred after baseline information was recorded. whereas participants and surgeons were aware of the group assignments, the outcome assessors and data analysts were remained blinded during the study period. operations were performed by the same team of sports medicine surgeons under general anesthesia.for the open wedge high tibial osteotomy group, those who were randomly assigned to the owhto group, owhto surgical procedure will be performed. for the closing wedge high tibial osteotomy group, hose who were randomly assigned to the cwhto group, cwhto surgical procedure will be performed. the sample size calculation was based on data from previous studies. accepting an α risk of 0.05 and a β risk of 0.2 in a bilateral contrast, the minimum sample size required for each group was 35. to compensate for an estimated 15% loss to follow up, at least 82 patients would be included.

Eligibility criteria:
inclusion criteria: the eligibility criteria for hto were spontaneous osteonecrosis of the knee of the medial femoral condyle, medial compartment oa, ahlbäck grades 1 or 2, femorotibial angle (fta) of ≤185, flexion contracture of ≤15° , lack of damage to the anterior cruciate ligament (acl) and posterior cruciate ligament, and no age restrictions . exclusion criteria: congenital deformity of knee joint, severe rheumatoid arthritis, charkoff's joint, injury of knee joint (injury of medial and lateral collateral ligament, patella fracture, etc.) or surgical history (meniscectomy, femoral or tibial fracture after surgery), large number of free bodies or soft tissue flexion contracture in the joint \>10º, and range of motion of knee joint \<100º.

Keywords: knee osteoarthritis high tibial osteotomy medial collateral ligament fracture healing
testing the gravitostat in humans: the impact of a weighted vest in patients post bariatric surgery on fat-free mass retention and weight loss

Conditions: Obesity

Summary: the mechanisms regulating fat mass homeostasis are incompletely understood although recent animal and human trials would suggest that there is a leptin independent regulatory pathway which may play a role in weight control and maintenance. although evidence would suggest that external loading in patients with obesity may promote body weight loss, this has not been explored in patients following bariatric surgery. the aim of this study is to investigate the mechanisms regulating weight loss and the potential role of the 'gravitostat' in fat free mass retention in patients following bariatric surgery.

the aim of the study is to investigate the mechanisms that regulate weight loss, particularly following bariatric surgery. previous animal studies have suggested that there is an underlying regulatory process controlled by 'the gravitostat' which is an evolutionary adaptation responsible for weight control and maintenance. studies exploring this concept in rodent models have suggested that artificially increasing the animal's weight with the implantation of weighted capsules results in greater weight loss in mice with obesity but does not affect those of normal weight. we will use weighted vests in patients following surgery to replicate this increased mechanical loading to determine whether a similar process occurs in humans. this will improve our understanding of the underlying processes regulating weight in patients with obesity and following bariatric surgery.

Eligibility criteria:
inclusion criteria: * undergoing bariatric surgery- roux en y gastric bypass or sleeve gastrectomy * age 18-60 * bmi \>30kg/m2 * reporting regular physical exercise (\>3 days/week) * willingness to comply with the study protocol exclusion criteria: * sedentary lifestyle * chronic pain that is constant and impairs the quality of life such as severe back, hip or knee pain * reduced mobility requiring the use of a mobility aid * undergoing revisional surgery * concerns from the investigator that the participant will be unable to fully comply with the study protocol

Keywords: bariatric surgery obesity weight loss maintenance
atopic dermatitis biomarker identification trial in omalizumab usage

Conditions: Atopic Dermatitis; Atopic Eczema

Summary: this study aims at evaluating the therapeutic potential of omalizumab in atopic dermatitis, and to work out biomarkers predictive of treatment response.


Eligibility criteria:
inclusion criteria: * age ≥ 18-70 years of age, body weight ≥ 20 kg and ≤ 150 kg * dermatological diagnosis of ad, scorad \>=20 * a positive rast (≥cap1) result for at least one aeroallergen specific ige and total ige \>=100ku/l at screening (or within the previous 12 months) * eligible to receive systemic therapy for ad in accordance to local guidelines * signed informed consent from patient exclusion criteria: * evidence of skin disease other than ad (e.g. psoriasis) at the inclusion time * treatment with systemic ad medications or any investigational drug within a 30-day washout period * concomitant treatment with substances interfering with the immune system * permanent severe diseases, especially those affecting the immune system, except asthma * pregnancy or breast feeding * history of food or drug related severe anaphylactoid or anaphylactic reaction(s) * history or presence of epilepsy, significant neurological disorders, cerebrovascular attacks or ischemia * history or presence of myocardial infarction or cardiac arrhythmia which requires drug therapy * elevated serum ige levels for reasons other than allergy and/or urticaria (e.g.: parasite infections, hyperimmunoglobulin e syndrome, wiskott - aldrich syndrome or clinical allergic bronchopulmonary aspergillosis) * evidence of severe renal dysfunction or significant hepatic disease * evidence for active infection that in the opinion of the investigator would compromise the patient's ability to tolerate therapy * history of malignancy of any organ system, treated or untreated, whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin * clinically significant laboratory abnormalities (not associated with ad) at visit 1 * known hypersensitivity to any ingredients, including excipients (sucrose, histidine, polysorbate 20) of the study medication or drugs related to omalizumab (e.g.: monoclonal antibodies, polyclonal gammaglobulin) * patients who are considered potentially unreliable or where it is envisaged the patient may not consistently attend scheduled study visits * patients with serious psychiatric and/or psychological disturbances * patients with a history of drug or alcohol abuse * patients who are unable to complete a patient diary or complete questionnaires on paper * patients with any other condition or prior/current treatment, which in the opinion of the investigator renders the patient ineligible for the study schedule

Keywords: atopic dermatitis (atopic eczema)
measuring and improving coproduction using cooperate

Conditions: Cystic Fibrosis; Chronic Disease

Summary: the purpose of this study is to identify new methods of measuring and improving collaborative goal setting between patients and clinicians in adult cystic fibrosis care.

this study has 3 specific aims: aim 1 will assess the construct validity of the cooperate measure in the before phase of a before-and-after study in adult cystic fibrosis care settings. the cooperate measure is a generic, patient-reported experience measure of collaborative goal setting that was recently developed in consultation with patients and other key stakeholders. aim 2 will assess the impact of the cooperate prompt intervention on collaborative goal setting and other outcomes in a before-and-after study in adult cystic fibrosis care settings. the cooperate prompt intervention is a set of questions delivered to patients immediately before the clinical encounter that elicit their concerns and goals. aim 3 will evaluate the feasibility and acceptability of implementing the cooperate prompt and measure in routine adult cystic fibrosis care.

Eligibility criteria:
inclusion criteria: 1. have a diagnosis of cystic fibrosis 2. are 18 years of age or older 3. can read and write in english 4. are attending a participating site for a routine cystic fibrosis care visit 5. have already consented to participate in the cystic fibrosis foundation patient registry 6. allow study researchers to access their cystic fibrosis foundation patient registry information and link it to their study data 7. have not previously participated in the study exclusion criteria: 1. do not have a diagnosis of cystic fibrosis 2. are less than 18 years of age 3. cannot read and write in english 4. are not attending a participating site for a routine cystic fibrosis care visit 5. have not already consented to participate in the cystic fibrosis foundation patient registry 6. do not allow study researchers to access their cystic fibrosis foundation patient registry information and link it to their study data 7. have previously participated in the study
cortical enhancement of posture, movement planning, and execution of upright reaching following stroke

Conditions: Stroke; Upper Extremity Paresis

Summary: stroke is the leading cause of disability and diminished quality of living that frequently includes impairments of postural control and upper extremity (ue) function. the interaction of posture and ue coupling in terms of movement planning, initiation, and execution is not well understood. startreact responses triggered by a loud acoustic stimulus (las) during the planning and preparation of goal intended actions has been used to probe the state of brainstem neuronal excitability related to posture and movement sequencing. the purpose of this study is to examine posture and goal-directed movement planning and execution using startreact responses and to evaluate posture and ue movement sequence during reaching while standing in individuals with chronic hemiparesis and healthy controls. secondly, the investigators will determine the modulatory role of the cortical premotor areas (pmas) in startreact responses in healthy controls and in persons with stroke by using transcranial direct current stimulation (tdcs) to up- or down-regulate pmas excitability.


Eligibility criteria:
inclusion criteria for stroke: * unilateral cortical or white matter subcortical stroke * age 40 yrs and older * ≥ 6 months post ischemic stroke or ≥ 12 months post hemorrhagic stroke * residual arm hemiparesis as indicated by fugl-meyer upper extremity score between 20-65 * having the ability to perform reaching movements with the paretic arm in standing without an assistive device. exclusion criteria for stroke: * stroke involving bilateral hemisphere, brainstem or cerebellum * any medical condition precluding participation in testing * other health conditions affecting balance and upper extremity movement function beyond the effects of stroke. inclusion criteria for healthy controls: * age-matched to the stroke subjects * without a history of stroke or any known neurological conditions * having the cognitive ability to follow two-step commands and give informed consent exclusion criteria for healthy controls: * any medical condition precluding participation in testing * other health conditions affecting balance and upper extremity movement function beyond the effects of stroke. participants were also excluded if they did not meet the tms safety criterion including having implantable medical devices, history of seizures, taking medications to reduce anxiety, sedatives, and seizure, and pregnancy.

Keywords: startreact response transcranial direct current stimulation postural control
study of skin and muscle parameters using a skin sensor

Conditions: Skin Wounds

Summary: the aim of this study is to assess the role of skin sensors in obtaining reliable and accurate serial measurements of skin parameters in the context of cutaneous skin wound healing.


Eligibility criteria:
inclusion criteria: * males and females age 18 and over * recent (post-operative day 0-90) skin surgery of the trunk,extremities, head or neck for minor skin problems resulting in sutured wounds or open granulating wounds. * otherwise good general health as assessed by the investigator * the subject has the willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator. exclusion criteria: * under 18 years of age * pregnancy or lactation * subjects who are unable to understand the protocol or to give informed consent
comparing soybean oil-based (intralipid) with an olive oil-based (clinoleic) lipid emulsion on healthy volunteers

Conditions: Diseases, Metabolic; Insulin Sensitivity

Summary: many patients in the hospital who are malnourished or not eating received intravenous feeding or total parenteral nutrition (tpn). despite improving nutrition, tpn may increase the risk of infections and hospital complications. we do not know why tpn increases hospital complications, but it may be caused by the high sugar or fat content in tpn solutions. the investigators believe that the high sugar and high fat content can limit the ability to fight infections and produce stiffness of blood vessels. this study will compare the effect of high sugar, high fat content or both on blood sugars, blood vessel function, on blood vessel function. the investigators will also compare the effect of different fats (olive oil and soybean) in the tpn solution on the risk of infection and blood vessel function on a total of 12 healthy subjects.


Eligibility criteria:
inclusion criteria: * healthy males or females, bmi 25 - 35 kg/m2, between the ages of 18 and 65 years exclusion criteria: * the patient is pregnant or breast feeding * subjects have or with history of diabetes, hypertension, fasting triglyceride levels \> 250 mg/dl, liver disease (alt 2.5x \> upper limit of normal), serum creatinine ≥1.5 mg/dl * smokers or ex-smoker \< 3 months of cessation, drug or alcohol abuse * mental condition rendering the subject unable to understand the scope and possible consequences of the study.

Keywords: intravenous feeding lipid emulsions, intravenous
rotator interval and intra-articular corticosteroid injection for frozen shoulder

Conditions: Adhesive Capsulitis

Summary: the purpose of this study is to compare ultrasound guided capsular corticosteroid injection into the rotator interval/anterior capsule and the gh joint with ultrasound guided corticosteroid injection into the gh joint only. both methods will be compared with placebo injections. primary outcome measure: pain reduction at week 6 secondary outcome measures: improvement of function (spadi, life quality, rom). 0-hypothesis: no difference between the methods. the investigators want to find out if the clinical effect of the combined capsular and intra-articular injections are better than placebo and better that intra-articular injections

3 groups, 50 patients in each, follow-up visits after 3, 6, 12 and 26 weeks.

Eligibility criteria:
inclusion criteria: * pain and stiffness in one shoulder 1 - 6 months * restriction of passive rom; \>= 30 degrees in two or more planes compared to other shoulder exclusion criteria: * systemic inflammatory disease * corticosteroid treatment last 3 months * poorly controlled diabetes mellitus * pregnancy * contraindications/allergy to corticosteroids and/or lidocaine * severe infections * osteoarthritis of the shoulder * fractures of the shoulder * rotator cuff pathology causing pain or disability * fibromyalgia * not able to understand norwegian

Keywords: adhesive capsulitis corticosteroids injection pain
evaluation of full-field coherence tomography for ex vivo staging and assessment of superficial esophageal squamous carcinoma: a pilot study

Conditions: Esophagus Cancer

Summary: new tools are needed to 1) diagnose and 2) stage early esophageal squamous cell carcinoma (scc) in order to improve outcomes of this frequent and lethal cancer. optical coherence tomography (oct) is an optical technique, which can image human tissue ex vivo and in vivo with a resolution around 30µm and with a depth of 1mm. full-field optical coherence tomography (ffoct) is a new modality, which allows to image an ex vivo specimen with a cellular resolution and to perform 3d reconstruction. this device has never been tested on esophageal specimens. therefore, the aim of this non-interventional research is 1) to determine ffoct diagnostic criteria for scc and 2) to figure if ffoct allows the staging of the depth of invasion in scc. to achieve these goals, we will image ex vivo 10 specimens of endoscopic resection of scc (endoscopic mucosal resection (emr) and submucosal dissection (esd)) using an ffoct device and we will compare the results with histological analysis of these specimens.

general study methodology the study presents the following characteristics: * observational * non interventional imaging study * single-centre * not controlled * prospective tests and analysis crf * filled by the investigator * data from the medical file of the patient imaging * as standard of care * before endoscopic resection the lesion will be characterized and pictures will be made using white light endoscopy, magnification techniques and electronic chromoendoscopy * immediately after endoscopic resection, the specimen will be prepared, oriented and scanned using the ffoct device (ce marking) * imaging movies will be then reviewed by trained readers and compared to movies of healthy patients, findings will be described * imaging movies will be compared to pathology slides pathology * after scanning the specimen will be sent to pathology for analysis * the pathology slides will be scanned to be kept in the study record together with their interpretation study schedule * total length of study: 24 months * methodology and regulatory: 6 months * recruitment period: 1 year * recruitment among the patients scheduled for the endoscopic procedure in the operative room * one single visit = inclusion the day of the procedure * no follow-up required * analyses: 3 months * paper writing: 3 months

Eligibility criteria:
inclusion criteria: * age of 18 years and more * confirmed diagnosis of scc based on previous biopsy * indication for endoscopic resection * patient who has read the information notice and confirmed its willing to participate exclusion criteria: * pregnancy * any contraindication for endoscopic treatment

Keywords: superficial esophageal cancer squamous cell cancer mini invasive imaging pre therapeutic assessment optical coherence tomography
enthesitis in patients with knee osteoarthritis

Conditions: Osteoarthritis

Summary: the current study was conducted to estimate the prevalence of knee cap enthesitis in patients with knee osteoarthritis and its relation to knee function.

the current study will based on a cross sectional hospital-based survey, conducted among patients with knee osteoarthritis , knee will assessed for the following items in both sides while patient lying supine with the knee flexed 40 degrees: 1. superior pole of the patella - quadriceps tendon enthesis: ● quadriceps tendon thickness \>6.1 mm ● suprapatellar bursitis ● superior pole of patella erosion ● superior pole of patella enthesophyte. 2. inferior pole of the patella - proximal patellar ligament enthesis: ● patellar ligament thickness \>4 mm ● inferior pole of patella erosion ● inferior pole of patella enthesophyte. 3. tibial tuberosity - distal patellar ligament enthesis ● patellar ligament thickness \>4 mm ● infrapatellar bursitis ● tibial tuberosity erosion ● tibial tuberosity enthesophyte. knee functional status was assessed using knee injury and osteoarthritis outcome score (koos) scale for pain, other symptoms, activities of daily living (adl), sport and recreation function (sport/rec) and knee-related quality of life (qol). low knee function was considered if the patient had score 50 or more in any koos scale parameter.

Eligibility criteria:
inclusion criteria: * primary knee oa diagnosed according to: american college of rheumatology radiologic criteria for knee osteoarthritis. * kellegren - lawrance scale grade ii. * on regular treatment by analgesics, or nsaids either topical or systemic. exclusion criteria: * recent knee trauma or intra-articular procedures. * previous knee surgery. * inflammatory joint diseases, as rheumatoid arthritis, crystal arthritis, and spondyloarthropathy * chronic systemic diseases that could affect patient functional ability; e.g renal, liver, cardiac impairment, or neurological disorder.

Keywords: enthesitis osteoarthritis ultrasound
cushing's syndrome before and after treatment (correct)

Conditions: Cushing Syndrome

Summary: the purpose of this study is to prospectively study patients with cushing's syndrome before and after treatment, with a special emphasis on physical function, quality of life, and circadian rhythms. the hypotheses are: * cushing's syndrome negatively impacts health-related quality of life (hrqol) and physical functioning * cushing's syndrome is associated with altered circadian rhythms at the whole body level and in peripheral target tissues. * these complications partially reverse following disease control.


Eligibility criteria:
inclusion criteria: * new (≤ 2 months) diagnosis of cushing's syndrome (cs) of endogenous etiology: * acth-dependent cs * acth-independent cs * age \>18 years * written informed consent exclusion criteria: * active cancer * iatrogenic or malignant cause of cs such as adrenocortical carcinoma * chronic heart failure (new york heart association class iv) * chronic kidney disease chronic kidney disease stage ≥3 (egfr \>30 ml/min) * liver disease in the form of cirrhosis * deemed unable to complete the study safely by investigator

Keywords: circadian rhythm quality of life