Kornimate/medical-research-clean huggingface dataset:
the effect of cryotherapy in pain control, function and quality of life in individuals with knee osteoarthritis

Conditions: Osteoarthritis, Knee

Summary: the purpose of this study is to verify the effect of cryotherapy in pain control, function and quality of life in individuals with knee osteoarthritis.

the purpose of this study is to verify the effect of cryotherapy in pain control, function and quality of life in individuals with knee osteoarthritis. this is a randomized controlled clinical trial, double-blinded. will participate in the study 60 patients with knee osteoarthritis, diagnosed with clinical and radiographic criteria of the american college of rheumatology, of both sexes, aged between 40 and 75 years. the total number of subjects will be divided randomly into two groups of 30 subjects each. during four consecutive days, for a period of 20 min, each group will receive one type of intervention around the knee with osteoarthritis: the cryotherapy group will receive an application of ice bags with compression and the placebo group will receive an application of sand bags with compression, the weight and volume of the sand bags will be similar to that used in cryotherapy. every individual will have the following variables evaluated one day pre- and one day post-intervention: pressure pain threshold (algometry), pain index (vas), physical function questionnaires (womac, koos) and physical activity (ipaq). two physical function tests will also be carried out: the 30s sitting and standing chair and the timed up and go (tug). thermographic images will also be obtained for further temperature analysis of the knee with osteoarthritis. moreover, after a period of 3 months, participants will perform a follow-up in which will be measured the vas, womac and koos questionnaires. also, some yes/no questions about the continued use of the therapy will be asked,

Eligibility criteria:
inclusion criteria: * diagnosed with knee osteoarthritis based on clinical and radiographic criteria of american college of rheumatology * osteoarthritis signals in at least one of the compartments of the knee joint (tibiofemoral and / or the patellofemoral joint) * do not perform regular physical activity - less than three times a week regularly * grade 2 or 3 according to the criteria of kellgren \& lawrence knee osteoarthritis radiographic examination scale. * minimum score of 4 cm in visual analogue scale (total 10 cm) * body mass index less or equal to 45 kg/cm2 exclusion criteria: * physical therapy within 3 months prior to the research project * corticosteroid injection in the knee (in the previous 6 months) * medical condition (cardiorespiratory, neurological and / or musculoskeletal) * previous ankle, knee or hip surgery

Keywords: osteoarthritis, knee cryotherapy thermotherapy hypothermia knee physiotherapy
an efficacy and safety study of ha44 gel administered topically for the treatment of head lice infestation

Conditions: Pediculosis

Summary: phase 2 study to assess the safety and effectiveness of a product to treat children and adults with head lice


Eligibility criteria:
inclusion criteria: * 2 years of age or older * body weight of at least 33 pounds * has an active head lice infestation at day 0. an active infection is defined as at least 3 live lice for the index subject and at least 1 live louse for the other household members * belong to a household of no more than 6 members, except where additional household members are \< 2 years of age * belong to a household with an eligible index subject between 2 and 12 years of age with active lice infestation * female subjects must be: * of non-childbearing potential (no history of menstrual periods, post-hysterectomy, or, post-menopausal for at least 2 years) or, * if of childbearing potential, must have a negative urine pregnancy test prior to treatment and agree to use a highly effective method of contraception from day 0 through the day 14 visit. exclusion criteria: * had treatment for head lice within 14 days prior to day 0 * has a household member(s) who is infested with lice but is not willing or not eligible for enrollment * has a condition or illness that, in the opinion of the investigator, may interfere with the study results * has an electrocardiographic abnormality, renal disease or impaired renal function, dermatological disease on the face, scalp, ears or neck, or active ophthalmological disease, moderate or severe scleral injection with conjunctival erythema or purulent discharge or allergic or perennial rhinitis requiring chronic treatment * has been using hormonal contraception for less than 3 months or is pregnant or lactating * has received systemic corticosteroids within 7 days prior to day 0 or planned while on study * receiving systemic or topical medication, which in the opinion of the investigator, may interfere with the study results * has received an investigational agent within 30 days prior to day 0
efficacy and safety of periogen in the treatment of periodontal bone defect

Conditions: Intrabony Periodontal Defect

Summary: periogen, containing rhpdgf and -beta-tcp, promotes gingival healing and corrects periodontal defects. this study will test the safety and efficacy of periogen in the treatment of periodontal disease

sixty eligible patients with periodontal defect will randomly receive either beta-tcp implantation (control group) or periogen implantation, containing beta-tcp and rhpdgf (drug group). the specified primary and secondary end points related to efficacy and safety will be assessed during 6 months study period.

Eligibility criteria:
inclusion criteria: 1. probing depth ≥7 mm at baseline 2. presence of ≥4 mm vertical bone defect with at least 1 bony wall after surgical debridement. 3. adequate keratinized tissue to permit complete tissue coverage of defect. 4. radiographic base of defect ≥3 mm coronal to the apex of the tooth. exclusion criteria: 1. failure to maintain adequate oral hygiene (plaque index\>2) 2. pregnant and lactating women 3. history of oral cancer or hiv 4. periodontal surgery on treatment-targeted tooth within the last year. 5. tooth mobility greater than grade ii. 6. study tooth exhibiting a class iii furacation defect 7. localized aggressive periodontitis 8. radiographic signs of untreated acute infection at the surgical site 9. recent history of smoking more than 20 cigarettes/day 10. known allergy to e.coli-derived products 11. using an investigational therapy within the past 30 days.

Keywords: rhpdgf, periodontal disease
a study of the effect of a nurse navigator program on high risk patients

Conditions: Patient Readmission; Arthroplasty, Replacement, Knee; Arthroplasty, Replacement, Hip; Heart Failure; Pulmonary Disease, Chronic Obstructive; Renal Insufficiency; Body Mass Index; Alcoholism

Summary: the purpose of this study is to examine if educational intervention in high risk patients can lead to decreased hospital readmissions when compared to patients who are not in the intervention program. additionally, to determine patient satisfaction with the educational program.


Eligibility criteria:
inclusion criteria: - require total or partial hip or knee replacement and have one or more of the following diagnosis: heart failure (hf); chronic obstructive pulmonary disease (copd); dialysis; alcohol abuse; low bmi. exclusion criteria: - decrease cognitive capacity to consent to the study.
the role of prophylactic central compartment neck dissection in the management of 2 to 4 cm papillary thyroid carcinoma

Conditions: Papillary Thyroid Carcinoma; Central Compartment Neck Dissction; Thyroidectomy

Summary: this randomized prospective study aims to evaluate the advantages and disadvantages (both oncologic and surgical) of prophylactic central compartment neck dissection for clinically node-negative 2-4 cm papillary thyroid carcinoma patients who have been treated either with total thyroidectomy alone or with total thyroidectomy + prophylactic central compartment neck dissection .


Eligibility criteria:
inclusion criteria: 1. ptc documented by fine needle aspiration cytology (fnac) (tir 4 or tir 5 according to the italian consensus for the classification and reporting of thyroid cytology \[15\]); 2. no pre-operative evidence of lymph node metastases (cn0) at palpation and neck ultrasound (us); 3. no clinical evidence of distant metastasis at diagnosis; 4. age ≥ 18 years. exclusion criteria: 1. histotypes other than ptc; 2. evidence of lymph node metastases during surgery even if not previously diagnosed; 3. presence of distant metastasis.

Keywords: papillary thyroid carcinoma prophylactic central compartment neck dissection thyroidectomy surgical complications outcomes
pet-mri in diagnosing patients with cancer, cardiac diseases, or neurologic diseases

Conditions: Cardiac Disease; Dementia; Inflammatory Disease; Fever of Unknown Origin; Vasculitis; Osteomyelitis; FDG Avid Cancers

Summary: this randomized pilot clinical trial studies how well positron emission tomography (pet)-magnetic resonance imaging (mri) works compared to standard-of-care pet-computed tomography (ct) in diagnosing patients with cancer, cardiac diseases, or neurologic diseases. pet-mri combines two imaging methods that can be used to evaluate disease. pet-mri is similar to standard-of-care pet-ct, but exposes the patient to less radiation. it is not yet known whether pet-mri produces better image quality than pet-ct in diagnosing patients with cancer, cardiac disease, or neurologic disease.

primary objectives: i. to assess and optimize image quality of pet and mri focusing on technical artifacts and their correction. ii. to assess the accuracy of pet quantification based on mr attenuation correction (mrac) derived from various mri sequences and reconstruction algorithms including the effect of routinely used gadolinium-based contrast agents on mrac. iii. to determine the clinical and diagnostic accuracy of pet-mri in comparison to standard-of-care diagnostic imaging. iv. to assess the efficacy and workflow in combining pet and mri in one single examination as compared to separate imaging studies. v. to assess the potential for radiation dose reduction if pet-ct is substituted by pet-mri, thus avoiding the radiation exposure from the ct-component.

Eligibility criteria:
inclusion criteria: * clinically indicated pet/pet-ct (with or without clinically indicated diagnostic mri) * presenting with one of the four conditions specified below * fludeoxyglucose f 18 (fdg) avid cancers * cardiac disease (cardiac viability assessment) * neurologic disorders (dementia) * inflammatory disease (for example fever of unknown origin, vasculitis, osteomyelitis) exclusion criteria: * pregnancy and lactation * contraindications to undergo mri * cardiac pacemaker and metal devices (as specified in a separate mri informed consent) * claustrophobia or inability to tolerate mri examination (lay still for approximately 1 hour and hold breath intermittently) * previously known allergies against mri contrast agents (exclusion criterion only for contrast enhanced mri) * renal insufficiency: glomerular filtration rate (gfr) \< 40ml/min/1.73m\^2 and following european society of urogenital radiology (esur) guidelines (exclusion criterion only for contrast enhanced mri) * individuals who are not willing or capable of giving informed consent or assent (with legal guardian consent)
a trial to evaluate the characteristics of patients treated for advanced renal cell carcinoma with nexavar ®

Conditions: Carcinoma, Renal Cell; Carcinoma, Renal Cell (Advanced)

Summary: evaluation of the efficacy and safety of nexavar ® in advanced renal cell carcinoma (rcc) and calculation of related medical costs.


Eligibility criteria:
inclusion criteria: * patients with diagnosis of advanced rcc and decision taken by the investigator to prescribe nexavar®. the patients should have sufficient knowledge of french or dutch to be able to participate in the study exclusion criteria: * exclusion criteria must be read in conjunction with the belgian product information

Keywords: advanced renal cell carcinoma ( rcc)
hypotension prediction 2 study in cardiac surgery and postoperative icu admission

Conditions: Intraoperative Hypotension; Postoperative Hypotension; Hypotension

Summary: this trial registration serves as an amendment incorporating the ipd sharing statement. this study already has a trial registration (2021 april 30) in the netherlands trial registry (reference number nl9449, https://trialsearch.who.int/). however, the ntr register is subject to a merger with another dutch register. this means that existing registrations are still visible, but can no longer be adjusted. study summary: hypotension in the operating room (or) and during post-operative icu admission is common in surgical patients and even more prevalent in cardiac surgery patients. it is associated with adverse outcomes and while these events are preventable, current management is predominantly reactive. edwards lifesciences (irvine, ca) has developed the hypotension prediction index (hpi), an early warning system that predicts an hypotensive event, defined as map below 65 mmhg, with high accuracy minutes before it occurs. at the time of writing the protocol this model has not been tested in a clinical trial in cardiac surgery patients or icu admitted patients. the aim of the hype-2 trial is to assess whether the hpi-algorithm can reduce the time-weighted average (twa) of intra- and postoperative hypotension in elective on-pump coronary artery bypass graft (cabg) surgery patients.

population studied: all adult patients undergoing elective on-pump cabg surgery or cabg with additional single heart valve surgery (e.g. valve repair or replacement), requiring a radial arterial line and an intended target map of 65 mmhg or above during both surgery (excluding cardiopulmonary bypass pump time (cbp)) and during mechanically ventilated phase of duration of icu admission.

Eligibility criteria:
inclusion criteria: * aged 18 years or older at inclusion * planned for elective on-pump cabg surgery or cabg with additional single heart valve surgery (e.g. valve repair or replacement) * planned to receive standard monitoring for cardiac surgery * target map of 65 mmhg or above during surgery * target map of 65 mmhg or above during the mechanically ventilated phase of icu admission exclusion criteria: * known cardiac shunts (significant) * severe cardiac arrhythmias (including but not limited to persistent atrial fibrillation prior to surgery) * expected to receive an hemodynamic assist device (e.g. intra-aortic balloon pump) during surgery * dialysis dependent kidney failure prior to surgery * planned to receive perioperative goal directed therapy (pgdt) other than standard intraoperative care * previous cardiac surgery in medical history

Keywords: intensive care unit cardiac surgery coronary artery bypass grafting
secukinumab open label roll-over extension protocol

Conditions: Autoimmunity, Inflammation

Summary: the purpose of this study is to assess long term safety in participants who have completed a novartis trial with secukinumab, have been judged by the investigator to benefit from continued treatment with secukinumab, and are unable to obtain the marketed secukinumab formulation.


Eligibility criteria:
inclusion criteria: 1. signed informed consent must be obtained for adult participants before any assessment is performed. written informed assent and parental permission (age as per local law) must be obtained for pediatric participants before any assessment is performed. if participants reach age of consent (age as per local law) during the study, they will need to also sign the corresponding study informed consent(s). 2. ability to communicate effectively with the investigator, to understand and willing to comply with the requirements of the study. 3. participant has completed treatment per protocol in a novartis study of secukinumab (unless otherwise specified in a parent study protocol). participants, who derive benefit from the treatment with secukinumab but have not completed the treatment in certain parent studies, due to parent study termination by novartis, may be eligible if the termination was due to reasons other than safety or lack of efficacy (technical / administrative reasons). 4. participant is deriving benefit from secukinumab, investigator believes he/she would continue to derive benefit from secukinumab and the benefit outweighs the risk, based on the investigator's judgement. 5. participant is unable to obtain access to the marketed secukinumab formulation per local prescription and/or reimbursement guidelines. exclusion criteria: 1. participant has prematurely discontinued study treatment in the parent protocol. 2. women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using methods of contraception during the entire study or longer if required by locally approved prescribing information (e.g., in european union (eu) 20 weeks).

Keywords: secukinumab, post trial access
impact of oct on outcomes in ami

Conditions: Acute Myocardial Infarction

Summary: this protocol describes a retrospective, single-center study intended to test the impact of optical coherence tomography(oct) on long term clincical outcomes in patients with acute myocardial infarction(ami). all the patients will be followed by intracoronary oct at medium follow-up of 3 years.


Eligibility criteria:
inclusion criteria: * age≥18 years old * patients undergo cardiac catheterization and percutaneous coronary intervention(pci) for ami(stemi or nstemi) st-segment elevation myocardial infarction was defined according to the universal definition of myocardial infarction, symptoms onset≤ 24h.nstemi was defined as elevated troponin levels and the absence of st elevation at the time of diagnosis, pci was performed within 24hours after symtoms onset. * sufficient quality of the oct recording allowing for corelab analysis. exclusion criteria: * ostial of left main disease * cardiogenic shock or severe hemodynamic instability * severe renal insufficiency (creatinine clearance ≤30 ml/min) * bacteraemia or septicaemia * severe coagulation disorders * patients with life expectancy less than 1 year * patients who refuse to sign the informed consent form

Keywords: tomography, optical coherence stemi nstemi major adverse cardiovascular event
effect of low level laser therapy on pain induced by placement of orthodontic separators in pediatric patients

Conditions: Levels of Pain

Summary: the primary goal of the study is to determine if there is a difference in pain levels following the use of low level laser therapy versus placebo and control after placement of elastomeric orthodontic separators in pediatric patients. to test this, the investigators will assess the patient's pain levels immediately following separator placement and 24 hours post-operatively but having patients rate their pain on a 10 cm visual analog scale (vas). patients will be randomly assigned to one of three groups: treatment, placebo, and control. the aim of this study is to establish whether or not low level laser therapy can be used to reduce pain in pediatric patients following separator placement.


Eligibility criteria:
inclusion criteria: * absence of acute or chronic dental disease and periodontal disease * free from severe systemic disease * no fixed orthodontic appliances currently placed * no ankylosis or tooth implants within dentition * no analgesic drug consumption for 48 hours preceding the study and during the study, a minimum age of 6 years exclusion criteria: * presence of a diastema where the separator would be placed * conditions that could alter nociception, such as current or previous use of anti-inflammatory and analgesic drugs, antidepressants, anticonvulsants, and oral contraceptives * any medical conditions or medications that may contraindicate use of certain light/laser sources such as low level laser therapy (lllt)
study of the role of oncostatin m in head and neck squamous cell carcinoma

Conditions: Head and Neck Cancer; Cytokine

Summary: the romcor study will be interested in the impact and the role of oncostatin m (osm), a cytokine belonging to il-6 superfamily, in the physiopathology of head and neck squamous cell carcinoma. the study team will study the impact of the presence of osm and its main receptor osm-r2 on several survival outcomes (overall survival, progression free survival) by multiple technics such as immunohistochemistry, transcriptomic in situ assays and spatial transcriptomic. furthermore, the study team will try to show a link between serum level of several cytokines and in situ tumoral osm.


Eligibility criteria:
inclusion criteria: * over 18 years of age; * with suspected squamous cell carcinoma of the oral cavity, oropharynx or pharyngolarynx (any stage); * with healthy, untreated contralateral mucosa and no contraindications to biopsy; * with no history of any type of cancer; * with a who performance status index of 0 to 2 inclusive ; * able to receive treatment according to current european society of medical oncology guidelines ; * without guardianship, curatorship or subordination; * benefiting from a social security scheme or benefiting from one through a third party; * have given informed consent to participate in the study. exclusion criteria: * previously pre-treated in the ear, nose, throat sphere by radiotherapy or having already received anti-cancer chemotherapy; * on long-term immunosuppressive therapy, defined as taking an immunosuppresseur, identified as such in the atc classification, for 7 days, cortico-therapy \> 7.5mg/day for more than 3 months, treatment or history of anti-cd20 treatment within the year, or regular plasmatic exchange or gamma globulin infusion; * benefiting from enhanced protection, i.e. minors, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social establishment, adults under legal protection; * pregnant or breast-feeding women of childbearing age (menopause must be documented and more than 2 years old) who refuse or do not have an effective method of contraception (hormonal/mechanical: oral, injectable, transcutaneous, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total oophorectomy) for the duration of the study. * final diagnosis of non-squamous cell carcinoma
comparison of the difficulty on insertion of iud devices between nulliparous and multiparous women

Conditions: Complication of Device Insertion

Summary: in this study the investigators compare the difficulty at insertion of iud between nulliparous and parous women. the investigators compare the pain reported by the patient to the difficulty reported by the professional that performed the insertion. the investigators hypothesis is that there is no difference between nulliparous and multiparous patients.

in our study we compare the difficulty at insertion of iud between nulliparous and parous women with an without cesarean section. we compare the pain reported by the patient to the difficulty reported by the professional that performed the insertion. we also compare the pain the patient refers on the day of insertion and the pain the patient refers to remember a month after insertion. our hypothesis is that there is no difference between nulliparous and multiparous patients.

Eligibility criteria:
inclusion criteria: * healthy women exclusion criteria: * pregnancy * use of pain medication previous to the insertion * prior use of iuds

Keywords: iud device insertion nulliparous multiparous pain