Kornimate/medical-research-clean huggingface dataset:
evolution of the state of health of patients undergoing surgery for osteoarticular surgery

Conditions: Osteoarthritis

Summary: osteoarticular surgery is frequently associated with the occurrence of moderate to severe postoperative pain. this pain can persist and become chronic post-surgical pain that is often debilitating. the transition between early postoperative pain and chronic pain is poorly understood, which complicates treatment.


Eligibility criteria:
inclusion criteria: * patient aged ≥18 years * underwent osteoarticular surgery between 01/01/2019 and 31/12/2022. * having been followed up with the administration of at least 1 qor-15f questionnaire postoperatively * subject who has not expressed his opposition to the reuse of his data for scientific research purposes. exclusion criteria: - subject who expressed their opposition to participating in the study has

Keywords: osteoarthritis chronic pain osteoarticular surgery
vestipitant 28-day tolerance study

Conditions: Sleep Disorders

Summary: this study is a 28-day polysomnographic and subjective assessment of oral vestipitant 15mg/day for treatment of primary insomnia in adults outpatients.


Eligibility criteria:
inclusion criteria: * male and female aged 18-64 years inclusively with diagnosis of primary insomnia according to diagnostic and statistical manual of mental disorders -text revision (dsm-iv-tr) criteria 307.42 * psg variables collected during 2consecutive psg screening nights falling as follows: tst between 240-420 mins inclusive (both nights) - lps (latency to persistent sleep): mean not less than 20mins, each night not less than 15 mins - waso (wake after sleep onset): mean not less than 60mins, each night not less than 45mins * women: non child bearing potential or if child bearing potential agree on contraceptive methods listed in protocol exclusion criteria: * clinically significant psychiatric and neurological disorders (sleep disorders other than primary insomnia, history of alcohol orother substance abuse or dependnce); * nightshift or rotating shift-work; * lifestyle habits in agreement with protocol requirement: caffeine - alcohol intake and smoke * healthy according to gsk criteria - laboratory and ecg limits set in the protocol

Keywords: polysomnography (psg) adults primary insomnia
prognostic role of inhibitor of apoptosis protein overexpression on recurrence rate in cervical cancer

Conditions: Cancer of Cervix; Apoptosis

Summary: overexpression of inhibitors of apoptosis proteins (iaps) in patients treated for locally advanced cervical cancer with exclusive radio-chemotherapy may have a prognostic role on the local recurrence rate at 24 months.

cervical cancer remains one of the most common cancers in women in terms of both incidence and mortality. human papilloma virus carriage is a necessary condition for the development of these cancers but is not the only factor responsible for malignant transformation. numerous molecular alterations come into play in the development of these tumours, involving the activation of oncogenes or the inactivation of tumour suppressor genes. treatment of locally-advanced cancer is based on radiotherapy or a combination of radiotherapy and chemotherapy. responses to anti-neoplastic treatments remain very heterogeneous from one woman to another. predicting the response to these treatments would make it possible to envisage early therapeutic alternatives for patients identified as not very sensitive to standard treatments. iaps (inhibitors of apoptosis proteins), which include xiap, ciap1 and ciap2, are proteins involved in many cancers and capable of downregulating tumour cell apoptosis. it seems justified to investigate the role of these iaps in resisting apoptosis-inducing anti-neoplastic treatments such as chemotherapy or radiotherapy. the aim of our study is to assess the prognostic role of overexpression of iaps in locally advanced cervical cancer treated exclusively with radio-chemotherapy. this research seems all the more important as iap-inhibiting molecules are currently being studied in other types of cancer (ear, nose and throat cancers) and appear to have a very encouraging radiosensitising effect. the hypothesis is that overexpression of iaps in patients treated for locally advanced cervical cancer with exclusive radio-chemotherapy has a prognostic role on the local recurrence rate at 24 months.

Eligibility criteria:
inclusion criteria: * patients treated with the exclusive radio-chemotherapy combination for locally advanced cervical carcinoma (stage ib-ivb according to figo classification). * patients aged ≥ 18 years. * patients with a minimum of 2 years post-treatment follow-up. * patients for whom the initial biopsy specimen (before treatment) is available. * patients who have not indicated that they do not wish to participate in the study. * patients affiliated to or benefiting from a health insurance scheme. exclusion criteria: * patients under court protection, guardianship or curatorship.

Keywords: apoptosis inhibiting proteins cervical cancer apoptosis
study of red bull™ sugar-free drink for reduction of fatigue in prostate cancer patients receiving lhrh agonist therapy

Conditions: Fatigue

Summary: the purpose of this research study is to find out if red bull™ sugar-free drink can reduce fatigue in prostate cancer patients receiving lhrh agonist therapy.


Eligibility criteria:
inclusion criteria: * histologically confirmed prostate cancer * currently receiving lhrh-agonist therapy for greater than 6 months * measurable fatigue, defined as a score of ≥ 2 on the bruera global fatigue severity scale * able to swallow red bull™ sugar-free drink * life expectancy of at least 1 year * able to read and write in english * willing to limit consumption of alcohol to one drink per day exclusion criteria: * current malignancy or received treatment for a previous malignancy within the last 3 years other than prostate cancer (exceptions are superficial bladder cancer or non-melanoma skin cancer) * myocardial infarction within past 6 months * any unstable serious co-existing medical condition(s) including but not limited to unstable or poorly controlled coronary artery disease, chronic atrial fibrillation, uncontrolled hypertension, uncontrolled diabetes, severe bleeding diseases or immune disorders * evidence of drug or alcohol abuse * known hypersensitivity to caffeine * known history of liver and kidney insufficiencies * known contraindications to red bull™ use
first-in-human study of cls003 icvt in subjects with cutaneous warts

Conditions: Cutaneous Warts

Summary: this phase i/iia study has an open-label, first-in-human (fih), single center design to assess the safety, pharmacokinetics (pk) and pharmacodynamics (pd) of multiple doses of topically applied cls003 in healthy subjects with cutaneous warts.


Eligibility criteria:
inclusion criteria: * healthy subjects (male, non-pregnant female), 18 to 65 years of age, inclusive. * body mass index (bmi) between 18 and 30kg/m2, inclusive * fitzpatrick skin type i-ii-iii-iv * at least 4 cutaneous warts on the hands, separated by at least 1cm of skin exclusion criteria: * for women, a positive pregnancy test and/or nursing at screening * a positive test for drugs of abuse at screening * history of alcohol or illicit drug abuse * positive test results for hepatitis b, hepatitis c or hiv * have used salicylic acid or any other over-the-counter- wart-removing product in the treatment area within 30 days prior to enrollment * have received cryotherapy in the treatment area within 60 days prior to enrollment * have required systemic intake of immunosuppressive or immunomodulatory medication (including oral or parenteral corticosteroids) with 30 days prior to enrollment or during the course of the study.

Keywords: safety pharmacokinetics (pk) pharmacodynamics (pd) cls003
pharmacokinetic study of fluconazole in premature infants

Conditions: Very Low Birth Weight Infant

Summary: the purpose of this study is to investigate the pharmacokinetics of fluconazole which is used as prophylaxis of invasive fungal infection in premature infants.


Eligibility criteria:
inclusion criteria: * very low birth weight infant (birth weight \< 1,500 g) who were admitted to the nicu before day 3 of life * informed consent from the parents exclusion criteria: * major congenital anomaly * expired within 72 hours of life * liver failure (ast or alt levels with three times the upper limit of the range of normal values or higher) * proven congenital or intrauterine fungal infection

Keywords: fluconazole
absorption and systematic pharmacokinetics of idp-121 lotion in subjects with acne vulgaris

Conditions: Acne

Summary: open-label study designed to assess the safety and plasma pk of tretinoin and relevant metabolites after topical dermal application of idp-121 lotion.

open-label study designed to assess the safety and plasma pk of tretinoin and relevant metabolites after topical dermal application of idp-121 lotion in subjects with moderate to severe acne vulgaris under maximal use conditions.

Eligibility criteria:
key inclusion criteria: * male or female, between the ages of 9 and \<17 years (16 years 11 months inclusive). * written and oral informed consent must be obtained. subjects less than age of consent must sign an assent for the study and a parent or legal guardian must sign the informed consent. * subject must have a score of 3 (moderate) to 4 (severe) on the evaluator's global severity assessment at the screening and baseline visit in the facial area. * subjects with facial acne inflammatory lesions count no less than 20 but no more than 40. * subjects with facial acne non-inflammatory lesions count no less than 20 but no more than 100. key exclusion criteria: * use of investigational drug or device within 30 days of enrollment or participation in research study or concurrent study with this study. * any dermatological conditions on the face that could interfere with clinical evaluations acne conglobate, acne fulminans, secondary acne, perioral dermatitis, clinical significant rosacea, gram negative folliculitis. * any underlying disease(s) or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive. * subjects with facial beard or mustache that could interfere with any study assessments.
long term follow up to determine the effects of collagenase santyl ointment on scar formation

Conditions: Follow up to Acute Wound Scar Study

Summary: the present study will evaluate the long term effects on scar formation for dermatome-induced skin wounds treated with collagenase santyl® ointment or vehicle (white petrolatum ointment) alone. the previous study, 017-101-09-001, utilized a small, experimental, cutaneous wound to evaluate both time to complete wound closure and quality of the resulting scar when collagenase santyl® ointment was used to treat the wound.


Eligibility criteria:
inclusion criteria: * subjects will be considered qualified for enrollment if they participated in the collagenase santyl® ointment study 017 101-09-001 and provide written informed consent. * the informed consent document must be read, signed, and dated by the suubject before conducting any study procedures or exams. in addition, the informed consent document must be signed and dated by the individual who consents the subject. a photocopy of the signed informed consent document must be provided to the subject and the original signed document placed in the subject's chart. * subject participated in the 017-101-09-001 study and received at least one application of a test article, whether collagenase santyl® ointment or white petrolatum. exclusion criteria: * n/a

Keywords: collagen, collagenase, scar
arimoclomol in sporadic inclusion body myositis

Conditions: Inclusion Body Myositis

Summary: inclusion body myositis (ibm) is the most common progressive and debilitating muscle disease beginning in persons over 50 years of age. this study will assess the safety and tolerability of arimoclomol in ibm as compared to placebo over 4 months of treatment.

ibm is a chronic disorder in which muscles become inflamed (swollen) and cause muscle weakening. the cause is unknown. there is new evidence to suggest that the pathology in ibm results from cellular changes induced by a variety of stressful events and diseases. in response to these stressful events the body's normal response is to increase the levels of heat shock proteins (hsp) to help counteract and stop these cellular changes. in people with ibm this increase does not appear sufficient enough to reverse these toxic cellular changes. arimoclomol causes the body to make more of this hsp protein. by increasing hsp levels in ibm patients we hope to reverse the toxic cellular changes that might be responsible for the pathology of ibm.

Eligibility criteria:
inclusion criteria: * meet the diagnostic criteria for definite or probable ibm (griggs 1995) * muscle function adequate for quantitative muscle testing * age \> 50 years * women must be postmenopausal or status post hysterectomy * for any patient currently taking medication for ibm, they must remain on current dosage for the extent of the study and last dosage change must be \> 30 days previous to enrollment exclusion criteria: * presence of any one of the following medical conditions: diabetes mellitus or patients taking anti-diabetic medications, chronic infection, chronic renal insufficiency, cancer other than skin cancer less than 5 years previously, multiple sclerosis or prior episode or central nervous system demyelination, or other chronic serious medical illnesses * presence of any of the following on routine blood screening: wbc \ 30 mg%, creatine \> 1.5 mg%, symptomatic liver disease with serum albumin \ upper range of control values * women who are pregnant or lactating * history of non-compliance with other therapies * coexistence of other neuromuscular disease * drug or alcohol abuse within the last 3 months * inability to give informed consent * known bleeding disorder * use of potentially renal toxic drugs * prior difficulties with local anesthetic

Keywords: myositis ibm inclusion body myositis
a study to evaluate flexible dose of paliperidone extended release (er) and clinical response in participants with schizophrenia

Conditions: Schizophrenia

Summary: the purpose of this study is to evaluate the effectiveness of paliperidone er for the treatment of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) participants.

this is a multi-center (when more than one hospital or medical school team work on a medical research study), open-label (all people know the identity of the intervention), prospective (study following participants forward in time), non-comparative study. the total study duration will be 12 weeks for each participant and will include following visits: screening, week 2, 4, 8, and 12 (end of treatment or early withdrawal). the effectiveness of paliperidone er will be evaluated at week 12 by the proportion of responders who are evaluated as "very much improved" or "much improved" on the clinical global impression improvement (cgi-i) scale. participants' safety will also be monitored throughout the study.

Eligibility criteria:
inclusion criteria: * participants who are diagnosed with schizophrenia (according to diagnostic and statistical manual of mental disorders \[edition 4\] criteria) * participants with clinical global impression-severity (cgi-s) score greater than or equal to 4 points (moderately ill) at screening * childbearing potential women who consented to the consistent use of the acceptable contraception (oral contraceptive, contraceptive injection, intrauterine device, double barrier method and contraceptive patch) * participants who are capable of and willing to fill out the questionnaire for themselves * participants who are compliant with self-medication or can receive consistent help or support exclusion criteria: * participants with the past history of neuroleptic malignant syndrome (high fever, rigid muscles, shaking, confusion, sweating more than usual, increased heart rate or blood pressure, or muscle pain or weakness) * participants with allergy or hypersensitivity to risperidone or paliperidone * participants who have taken clozapine, or have been exposed to the study drug within one month before screening * participants who have been treated with the long acting antipsychotic injection within 28 days * participants with significant risk including suicide or aggressive behavior

Keywords: schizophrenia paliperidone extended release (er)
comparison of diode laser-assisted vestibuloplasty and conventional vestibuloplasty

Conditions: Wound Heal; Vestibular Abnormality; Low-level Light Therapy; Surgical Wound

Summary: randomized controlled parallel designed clinical study aimed to compare vestibule depth gain and dimensional changes of wound area in individuals who underwent vestibule deepening surgery using diode laser and conventional technique

52 systemically healthy patients aged between 18 and 53 years (10 males and 42 females) with inadequate vestibular depth and insufficient attached gingiva in the anterior mandible were included in this randomized examiner- and patient-blinded, parallel design study. following nonsurgical periodontal treatment, patients were divided into 4 groups as follows: a) diode laser (l); b) diode laser+low level laser therapy (lllt); c) conventional surgery and conventional surgery+lllt, and vestibule deepening was applied to all subjects either with scalpel or laser assisted. scalpel surgery was performed as clark's vestibuloplasty. a local anesthetic was administered bilaterally to the mental area. then, a horizontal incision was prepared at the mucogingival junction with a scalpel blade 15c. all the muscle fibers over the periosteum were resected carefully. following, the mucosal flap was sutured to the depth of the vestibule sulcus with 4-0 polypropylene suture material, once every 4 mm, from a total of 5 regions. laser assisted vestibuloplasty was performed using diode laser. local anesthesia was achieved in the same manner as the control group (scalpel surgery). laser irradiation was performed in continuous wave mode, using a 980 nm diode laser with a power of 1.5w, 600 μm optical fiber. after adequate local anesthesia, ablation was started from the mucogingival junction and performed with horizontal movements parallel to the bone. the muscle attachments were slowly released until the deepest point of the wound site was 5 mm. the mucosal flap was not stabilized with sutures and periodontal dressing was not used to cover the wound area.

Eligibility criteria:
inclusion criteria: * patients were\> 18 years old and of both genders, * patients presenting inadequate vestibular depth and insufficient attached gingiva on incisors in the mandibular anterior region * full mouth plaque index (pi) and gingival index (gi) scores \< 1 * the patients had to be systemically healthy and nonsmokers exclusion criteria: * patients who had miller class ii and more advanced gingival recession in the region of the lower anterior incisors and interproximal attachment loss * patients who were taking medications that would interfere with the wound-healing process, pregnant or lactating women, * patients who had previously undergone periodontal surgery in the study area, who had orthodontic therapy and using fixed/removable dentures involving lower anterior teeth were excluded from the study.
the effectiveness of vitamin c in postoperative pain management of single-level posterior lumbar interbody fusion (plif)

Conditions: Fusion of Spine (Disease)

Summary: postoperative pain management remains a major challenge for surgeons. despite huge technological advances in pain management, many researchers have documented that unrelieved pain remains common after surgeries, which is estimated that up to 75% of patients do not achieve adequate pain relief postoperatively. the major goal in the management of postoperative pain is to minimize the dose of medications to lessen the side effects while still providing adequate analgesia, because side effects of commonly used pain medications are known to be the reasons that could lead to inadequate postoperative pain treatment. this goal is best accomplished with multimodal analgesia. one agent that can exert antinociceptive and pain reducing effects is vitamin c. vitamin c (ascorbic acid) is water-soluble, found throughout the body and is especially highly concentrated in the brain, which has antioxidant and neuroprotective properties. moreover, it has been proven that the plasma vitamin c concentration decreases after surgery and the requirement for vitamin c increases in surgical patients, possibly due to greater demand caused by increased oxidative stress. regarding the effect of vitamin c on acute pain, a result from a recent study with the aim to evaluate the potential role of vitamin c in reducing acute pain after laparoscopic cholecystectomy showed that supplementation with oral vitamin c significantly decreased morphine consumption after surgery. although vitamin c has potential for relieving postoperative pain, there has not been studied regarding the effectiveness of vitamin c for spine surgery, to date. this trial aimed to evaluate the effectiveness of vitamin c for surgery of lumbar spine.


Eligibility criteria:
inclusion criteria: * patients with a lumbar herniated intervertebral disc, lumbar spondylotic radiculopathy and/or myelopathy, which were diagnosed using lumbar spine radiographs and magnetic resonance images (mri) that corresponded to clinical manifestations and physical examinations * patients who underwent one-level plif * patients who volunteered for this study with written consent * patient who were followed-up for one year or more exclusion criteria: * fractures, infection, or tumors in the lumbar spine * patients with hemorrhagic disorders such as hemophilia and thrombocythemia * patient with a follow-up period of less than one year * patients who are not suitable for this study judged by the principal investigator

Keywords: vitamin c effectiveness pain management posterior lumbar interbody fusion
organizational infrastructure pediatric plan in bronchiolitis epidemics

Conditions: Bronchiolitis

Summary: acute bronchiolitis is a frequent respiratory viral infection of infants, responsible for 460,000 new cases per year in france. over the years, the number of hospitalizations during the epidemic season appears to be increasing. bronchiolitis epidemics lead to recurrent hospital disruption. the current trend towards a reduction of hospital beds is exacerbating the pressure on bronchiolitis epidemics on healthcare systems. in this context, the pediatric departments of montpellier university hospital, france, designed in 2014 a common organizational infrastructure pediatric plan (oipp) to to adapt to these multiple constraints while respecting the quality of care. this plan includes a referral flowchart for hospitalized children, an increase in medical and paramedical staff and a restructuring of the pediatric units, with a specific stratification into 4 levels of care. the study aims to assess the impact of our oipp on the overall length of stay for children hospitalized for bronchiolitis. the investigator also intend to measure the impact of the oipp on the length of stay within each unit, the number of transfers from one unit to the other and the number of readmissions within 30 days after hospital discharge. the cost of the implementation of the oipp in the structure will be analyzed.

the investigator compared data between two periods of time, e.g. the two consecutive years before the beginning of the oipp (winters 2012-2013 and 2013-2014) and two first years after the beginning of the oipp (winters 2015-2016 and 2016-2017).

Eligibility criteria:
inclusion criteria: * age \< 2 years * hospitalization for bronchiolitis exclusion criteria: * none

Keywords: bronchiolitis health care organizational change children epidemic cost