Kornimate/medical-research-clean huggingface dataset:
study to assess the efficacy and safety of ryanodex as adjuvant treatment in subjects with ehs

Conditions: Exertional Heat Stroke

Summary: a double-blind, parallel study of ryanodex for the adjuvant treatment of exertional heat stroke (ehs) compared to current standard of care (soc) for ehs.

following triage and primary assessment in the emergency medical facility, subjects will be randomized to 1 of 2 treatment arms, soc plus ryanodex or soc only. subjects will be dosed and followed for up to 6 hours post-randomization. current soc is limited to body cooling and supportive measures.

Eligibility criteria:
inclusion criteria: core body temperature of greater than or equal to 40.0 degrees c (104 degrees f); recent history of exertional activity; gcs score less than 13; tachycardia - exclusion criteria: clinical severe infection; hyperthermia secondary to another condition; endotracheal intubation;; sedative drugs administered prior to or at time of study entry; likelihood of head trauma within 6 months pre-study; positive pregnancy test; history of myocardial infection within 30 days; history of seizure disorder or epilepsy; concomitant or prior use of calcium channel blockers. -
bioequivalence study of aciclovir 5% cream in japanese healthy volunteers

Conditions: Herpes Labialis

Summary: this study is designed to show bioequivalence between current and new formulation of aciclovir cream 5% in keratin layer of the epidermis in japanese subjects


Eligibility criteria:
inclusion criteria: * healthy japanese adult males between 20 and 55 years of age, inclusive. healthy subjects are defined as individuals who are free from clinically significant disease as determined by their medical history, physical examination, clinical laboratory examinations, vital sign, 12-lead ecg, immunology tests and urinary drug screen test. * bodyweight \>50 kg and body mass index (bmi) between 18.5 and 28.0 at screening. * subjects must be capable of providing written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. * baseline qtc interval \<450 msec. * non-smoker or ex-smoker having ceased smoking for at least 6 months. * clinical laboratory examination (ast, alt, alp and ggt) at screening are within the normal range. * the subject is able to attend all visits and complete the study. exclusion criteria: * any clinically relevant abnormality identified on the screening physical examination, vital sign measurement, 12-lead ecg recording and/or clinical laboratory examination that is deemed by the principal investigator and/or medical monitor to make the subject ineligible for inclusion because of a safety concern. * history of regular alcohol consumption exceeding, on average, 14 drinks/week (1 drink = 5 ounces (150 ml) of wine or 350 ml of beer or 1.5 ounces (45 ml) of 80 proof distilled spirits) within 6 months of screening. * positive for urine drug at screening. * positive for syphilis, hiv antibody, hepatitis b surface antigen, hepatitis c antibody or htlv-1 antibody at screening. * donation of blood in excess of 400ml within 4 months or 200ml within 1 months prior to at screening. * history of drug abuse, or current conditions of drug abuse or alcoholism. * participation in a clinical study or post-marketing study with an investigational or a non-investigational product or device within 4 months of preceding the first application of study medication. * participation in another clinical study or post-marketing study in which the subject is or will be exposed to an investigational or a non-investigational product or device. * history of asthma, anaphylaxis or anaphylactoid reactions, severe allergic responses. * the subject has an allergy for any drug or idiosyncrasy. this excludes a pollen allergy without current symptoms. * at the part obtaining keratinized layer, having exanthem, pigment abnormality, the skin symptoms such as wounds and/or an excessive sunburn. * history of clinically significant itching, erythema and/or rash by any paster.

Keywords: aciclovir cream 5% volunteer japanese male bioequivalence
6 month follow up study on the changes of postural stability in parkinsonian patients in response to high frequency tms.

Conditions: Parkinson Disease

Summary: postural instability is one of the cardinal signs in parkinson's disease (pd). it represents one of the most disabling symptoms in the advanced stages of the disease. it is associated with frequent falls and loss of independence. the aim of the current study is to assess the long term efficacy of high frequency repetitive transcranial magnetic stimulation (rtms) on improving postural instability in pd patients.

thirty to forty pd patients will be recruited who fulfill the u.k parkinson's disease brain bank criteria for idiopathic pd. patients with mild to moderate disease severity according to uprs and modified hoehn and yahr staging, age ranged from 55-70 years, duration of illness from two to five years will be included. the patients who will match our inclusion criteria will be assigned randomly into two equal groups; control group (g1) will receive a designed physical therapy program and study group (g2) will receive 12 sessions of (5hz) rtms over the primary motor cortex in addition to the same physical therapy program as in g1. the treatment will be conducted three times per week, over four weeks. biodex balance system will be used to assess objectively balance indices (overall, anterio-posterior and medio-lateral balance index) and dynamic limit of stability (overall los score, time to complete test) pretreatment , posttreatment and one month later as a follow up.

Eligibility criteria:
inclusion criteria: * all included patients should fulfill the u.k parkinson's disease brain bank criteria for idiopathic pd. * patients with mild to moderate disease severity according to uprs and modified hoehn and yahr staging * duration of illness from two to five years were included. * all included patients should be medically and psychologically stable and of adequate cardiac function. * all included patients should haven't receive any rtms sessions before. * signed consent form should be taken from all included patients. exclusion criteria: * patients with implanted devices, serious medical illness or history of seizures were excluded. * patients with severe freezing phenomenon or severe tremors were excluded
diagnostic usefulness of interferon gamma release assay for active tuberculosis in immunocompromised patients

Conditions: Tuberculosis

Summary: for diagnosis of active tuberculosis, interferon-γ release assay based mycobacterium tuberculosis specific antigen may show higher sensitivity than tuberculin skin test in immunocompromised patients. therefore, interferon-γ release assay have a role as a rapid diagnostic adjunctive methods for active tuberculosis in immunocompromised patients.


Eligibility criteria:
inclusion criteria: * patient suspicious of active tuberculosis with immunocompromised condition * immunocompromised condition patients with 1. solid cancer with chemotherapy 2. hematologic malignancy 3. organ transplantation 4. immunosuppressant 5. esrd on renal replacement therapy 6. diabetes 7. advanced liver cirrhosis exclusion criteria: * patients with 1. less than 20 years 2. who don't agree the participation of study 3. hypersensitivity history to tuberculin 4. pregnancy

Keywords: suspicious of tuberculosis immunocompromised patients
pmcf study of ceraroot ceramic implants one-piece: 3 years follow up

Conditions: Tooth Loss; Ceramic Implant

Summary: the main objective is to evaluate the success / failure rate of ceraroot ceramic implants (one piece) during three year follow up.

traditionally the material of choice for dental implants has been titanium. the success of such material has been unquestionable for the last decades. however a number of issues arise lately regarding the biocompatibility or cytotoxicity or allergies regarding the degradation or oxidation particles within the bone or gum. esthetics has been a concern as well specially in patients with thin biotype where the metal may produce a grayish look of the mucosa. for this reason the dental community and patients have raised much interest in ceramic dental implants as a tooth colored and metal free alternative for dental implants. since 2006 ceraroot ceramic implants have been available in the market. the reason for designing this pmcf is to evaluate the long term success of ceraroot ceramic implants to achieve those objectives an observational study of patients that have received such implant is designed, using marginal bone loss as a primary response variable. it is estimated that a sample size 200 patients over the 3 year period is needed to achieve relevant data.

Eligibility criteria:
inclusion criteria: * patients that have received the studied ceramic implant after 27 august 2020. * patients of ceraroot clinic (barcelona) * age \>18 * single or multiple missing or hopeless teeth exclusion criteria: * smokers. * the patient is taking medications or having treatments which have an effect on healing in general (e.g. steroids, large doses of anti-inflammatory drugs). * untreated periodontal conditions

Keywords: zirconia implant zirconium oxide implant dental implant ceramic implant ceraroot one-piece monotype
prediction of perineal tears by striae gravidarum score

Conditions: Normal Labor

Summary: previous studies concluded that striae gravidarum assessment appears to predict the occurrence of perineal tears and recommend training the health personnel to calculate the total striae score which can help them decide if episiotomy is to be given or not. episiotomy definitely seems to be preventive for perineal tears but giving episiotomy for the same is still debatable as episiotomy in itself is associated with morbidity. the hypothesis is episiotomy done in patients with high score will definitely protects against perineal tears. so, the aim of study is to determine whether assessment of striae gravidarum score could predict occurrence of tears during labor or not, and if episiotomy will prevent perineal tears in women with high score.


Eligibility criteria:
inclusion criteria: 1. multipara 2. singleton pregnancy 3. full-term (37- 40 weeks) 4. average size fetus (2500-4000 gm) 5. cephalic-vertex presentation 6. spontaneous onset of labor 7. no scarred uterus 8. no medical diseases as hypertension 9. no obstetric complications as obstructed labor 10. women accepted to participate in the study exclusion criteria: 1. multiple pregnancy 2. women with previous cesarean sections 3. preterm labor 4. malpresentation 5. fetal macrosomia 6. medical diseases as diabetes and hypertension 7. women refuse to participate in the study
a safety and efficacy study of alg-1001 in human subjects with symptomatic focal vitreomacular adhesion

Conditions: Symptomatic Focal Vitreomacular Adhesion

Summary: evaluate the safety and efficacy of ophthalmic intravitreal injection of alg-1001 in human subjects with symptomatic focal vitreomacular adhesion


Eligibility criteria:
inclusion criteria: 1. symptomatic focal vitreomacular adhesion 2. vitreomacular traction syndrome 3. stage 1 and 2 macular holes, ≤ 350 µm 4. bcva of 20/25 early treatment diabetic retinopathy study (etdrs) or worse in the study eye 5. bcva of 20/800 etdrs or better in the fellow eye 6. male or female subjects, 18 years of age or older 7. signed informed consent exclusion criteria: 1. high myopes \> -8.0 d spherical equivalent 2. history of prior vitrectomy in the study eye 3. history of photocoagulation to the retina in the study eye 4. macular hole in the study eye \> 350 µm 5. subjects with epiretinal membranes in the study eye 6. subjects with broad vma, defined as vma of \>1500 µm 7. subjects with proliferative diabetic retinopathy (dr), neovascular age-related macular degeneration (amd), or retinal vascular occlusion in the study eye 8. subjects with aphakia in the study eye 9. subjects with uncontrolled glaucoma 10. subjects with lenticular or zonular instability 11. subjects with prior ocular surgery or intravitreal injection in the study eye within 90 days of study enrollment 12. pregnant or nursing women
telemedicine in sleep breathing disorders: a multicenter study.

Conditions: Obstructive Sleep Apnea Syndrome

Summary: in recent years medicine has been enhanced by the incorporation of technological innovations from areas as diverse as cell biology, biochemistry, genetics, biophysics and bioengineering. one of the few exceptions in this rapid process of implementing technological advances occurs in clinical medicine, where its penetration is much less effective than in other scientific and professional fields, or even in everyday life. attempts to tackle this problem have given rise to various initiatives in the us and europe, including spain. there is a surprising paucity of telemedicine systems in clinical practice, especially with respect to sleep-related breathing disorders, and most particularly obstructive sleep apnea (osa), where protocols are urgently needed to alleviate this healthcare problem represented by its under-diagnosis and comorbidity, as well as the long waiting lists for treatment. in others words, the growing awareness of sleep disorders, especially osa, has not been accompanied by strategic changes in the cost-effective diagnosis and/or treatment of these diseases. cpap therapy compliance is not always appropriate. helping patients during the first two months usually determines compliance. therefore, the development of strategies to support the patient during the first weeks is essential. however, this "collides" with reality, where it is difficult to properly care all patients because of congested sleep units. it is therefore necessary to implement new and imaginative control schemes especially at the beginning of the treatment. patients' follow-up performed by telemedicine technology is an option that aims to substitute the face-to-face visits or at least reduce them considerably. in a future context, the idea is that the professional in charge of cpap patients monitoring has on his/her agenda face-to-face visits and televisits (at distance) and information which patient will provide through online questionnaires with a certain frequency. in this sense, this project aims to analyze whether cpap treatment compliance of osa patients monitored by telemedicine techniques (website and televisits) is similar to that achieved by standard monitoring but more cost-effective. the study design is a multicenter randomized trial with parallel groups and blind final evaluation after cpap treatment following two different strategies: one through conventional monitoring in the hospital (face-to-face visiting) and another by telemedicine monitoring (non-contact visiting and website).


Eligibility criteria:
inclusion criteria: * diagnosis of osa; * 18-75 years; * cpap recommendation; * informed consent. exclusion criteria: * disabling hypersomnia; * pregnancy; * psychiatric disorders; * previous treatment with cpap; * clinical instability in the previous month; * inability to use information technologies (computers and web).
feasibility of telerehabilitation in hiv-patients

Conditions: Human Immunodeficiency Virus

Summary: the aim of this study is to assess the feasibility and the effects of a 6-week telerehabilitation on the three domains of the international classification of functioning, disability and health in hiv-infected patients under highly active antiretroviral therapy (haart). hiv-infected patients were randomized either into an endurance and resistance training exercise (erte) group or a control (con) group. telerehabilitation was realized in a public fitness center, with online guidance and weekly telephone advice, 3 times per week for 6 weeks. feasibility was determined by recruitment rate, retention rate and adverse events. secondary outcomes were impact on body composition, inflammation and coagulation (c-reactive protein, d-dimer), physical fitness and quality of life (whoqol-hiv).


Eligibility criteria:
inclusion criteria: * 18 years or older * under haart treatment * native french speaker exclusion criteria: * aids diagnosis * physical and/or psychiatric impairments that seriously impaired physical activity * pregnant * unstable (defined by any modification of health outcomes during the last 6 months).
demonstration of carbonyl stress on hair follicles

Conditions: Effluvium; Telogen

Summary: in this study, the investigator will try to highlight the presence of carbonyl compounds in the hair follicles of women with telogen effluvium (et) linked to stress of various origins (fatigue, infectious diseases, emotional stress ...).

at the cutaneous level, oxidative stress induces the formation of carbonyl compounds which, by binding to proteins, produce nonfunctional adducts inducing cutaneous aging. is this mechanism, called "carbonyl stress", also present in the scalp and can it be one of the mechanisms involved in the occurrence of reactive hair loss ? to demonstrate this, samples of hair follicles are made. the proteins are extracted from the samples and then assayed. the oxidized (carbonyl) proteins are labeled with specific fluorescent probes.

Eligibility criteria:
inclusion criteria: criteria related to the population : * women aged from 18 to 40 ans (included) * phototype i à iv included, according to fitzpatrick classification * hair length 5 cm on the sampling area (centro-parietal part) * last shampoo at least 2 days before the inclusion visit, without application of styling product, care or water between this last shampoo and the inclusion * informed consent signature criteria related to the studied condition: * et group: hair loss related to various etiologies evaluated by a questionnaire according to the investigator's opinion and positive pull test (at least 3 hair collected per lock of 50 to 60 hair) and * control group : no hair loss, evaluated by the questionnaire and negative pull test (less than 3 hair collected per lock of 50 to 60 hair) exclusion criteria: criteria related to population : * menopause * pregnancy, breastfeeding, childbirth for less than 6 months criteria related to pathology : for both groups: * alopecia causing hair loss on the upper part of the scalp * dermatological pathology or evolving cutaneous lesion in the scalp * control group only: * chronic unstabilized condition * acute evolving pathology criteria related to thetreatments : for both groups: * use for at least 1 month of minoxidil, aminexil in the 3 months before inclusion or ongoing * systemic treatment affecting hair growth * any treatment or dietary supplement for antioxidant or capillary control group only: * treatment of general thyroid disorders initiated or modified for less than 3 months prior to inclusion * treatment of anemia if started less than 3 months before inclusion * general treatment initiated or modified for less than 3 months prior to inclusion in the study
gynaecological follow-up of a subset of hpv-015 (nct00294047) study subjects

Conditions: Infections, Papillomavirus

Summary: this study is intended to provide up to a maximum of four years of annual oncogenic human papillomavirus (hpv) dna testing and cervical cytology examination for nct00294047 study subjects who displayed normal cervical cytology but tested positive for oncogenic hpv infection at their concluding nct00294047 study visit. women who were pregnant at their concluding nct00294047 study visit may also be included in this study, as no cervical sample could be collected at that visit. the objectives and outcome measures of the primary phase (nct00294047) are presented in a separate protocol posting.

cervarix or control \[al(oh)3\] has been administered in the primary study nct00294047.

Eligibility criteria:
inclusion criteria: * written informed consent obtained from the subject prior to enrolment. * subjects who the investigator believes that they can and will comply with the requirements of the protocol. * a subject previously enrolled in the study nct00294047 and who fulfils either of the following criteria: * displayed normal cervical cytology but tested positive for oncogenic hpv infection at her concluding nct00294047 study visit * was pregnant so that no cervical sample could be collected at her concluding nct00294047 study visit exclusion criteria: * a subject who at the nct00294047 concluding study visit displayed normal cervical cytology and who was negative for oncogenic hpv infection at that visit. * a subject who at the nct00294047 concluding study visit had a cervical lesion at that visit or who had a cervical lesion that required treatment at her nct00294047 exit colposcopy. * a subject for whom the cervical cytology results from the concluding nct00294047 study visit were unavailable for reasons other than pregnancy.

Keywords: hpv hpv vaccine cervical neoplasia human papillomavirus papillomavirus cervical cancer human papillomavirus (hpv) type 16/18 infections
[18]f-faza pet imaging study in patients with cancer of the head & neck, lung, renal cell, brain, lymphoma and neuroendocrine tumours

Conditions: Renal Cell Carcinoma; Neuroendocrine Tumours

Summary: positron emission tomography (pet) is a nuclear medicine procedure that uses positron emitting radiolabeled tracer molecules to visualize biological activity. the presence of hypoxia (low oxygen) is associated with poor prognosis in a variety of tumour types and treatment strategies targeting hypoxic cells have been developed. the pet tracer \[18\]f-faza can identify hypoxic areas, and changes in uptake during treatment may predict tumour response.

the proposed clinical trial will be a phase i/ii imaging, open label, single site study. in phase i, one 18f-faza pet scan will be conducted in patients with known squamous cell carcinoma of the head \& neck, sclc, nsclc, lymphoma, ggm, neuroendocrine tumours or renal cell carcinoma. in phase ii, three 18f-faza pet scans will be done on patients with the above tumours as follows: one pre-treatment, one mid course and one post-treatment.

Eligibility criteria:
inclusion criteria: * male or female greater than or equal to 16 years of age. * if female of child-bearing potential and outside of the window of 10 days since the first day of the last menstrual period, a negative pregnancy test is required. * patients with known primary or suspected metastatic squamous cell carcinoma of the head and neck, non-small cell or small cell carcinoma of the lung, lymphoma, gbm (greater than or equal to 3 glioma), neuroendocrine tumours, or renal cell carcinoma with at least one lesion \>1 cm in diameter.