Kornimate/medical-research-clean huggingface dataset:
phase iia proof of concept study of m5717-pyronaridine in adults and adolescents with acute uncomplicated plasmodium falciparum malaria (capture 1)

Conditions: Acute Malaria

Summary: the purpose of this study is to evaluate the safety, efficacy, and pharmacokinetic of the combination m5717 plus pyronaridine in participants with acute uncomplicated plasmodium falciparum malaria. pyramax (artesunate/pyronaridine) will act as an internal control providing reference safety data and a benchmark for the efficacy evaluation.


Eligibility criteria:
inclusion criteria: * participants with microscopic confirmation of acute uncomplicated plasmodium falciparum using giemsa-stained thick and thin film * p. falciparum parasitemia of 1,000 to 50,000 asexual parasites/microliter of blood in part a and p. falciparum parasitemia of \>1,000 to \<= 150,000 asexual parasites/microliter of blood in part b * axillary temperature \>= 37.5 degree celsius or tympanic temperature \>= 38.0 degree celsius (use as per coronavirus disease 2019 (covid-19) protocols at the site \[only at screening\]), or history of fever during the previous 24 hours (at least documented verbally) * the investigator confirms that each participant agrees to use appropriate contraception and barriers, if applicable * capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (icf) and this protocol * other protocol defined inclusion criteria could apply exclusion criteria: * mixed plasmodium infections as per thin film microscopy results * signs and symptoms of severe malaria according to world health organisation (who) 2021 criteria (who 2021) * known liver abnormalities, liver cirrhosis (compensated or decompensated), known active or history of hepatitis b or c (testing not required), underlying hepatic injury or known severe liver disease, known gallbladder or bile duct disease, acute or chronic pancreatitis, or severe malnutrition * known history or evidence of clinically significant disorders such as, cardiovascular, respiratory (including active tuberculosis), hepatic, renal, gastrointestinal, immunological \[including known human immunodeficiency virus-acquired immunodeficiency syndrome (hiv-aids)\], neurological (including auditory), endocrine, infectious, malignancy, psychiatric, history of convulsions, or other abnormality (including head trauma) * previous treatment with pyronaridine as part of a combination therapy during the last 3 months * prior antimalarial therapy or antibiotics with antimalarial activity within a minimum of their 5 plasma half-lives (or within 4 weeks of screening if half-life is unknown) * participants taking medications prohibited by the protocol * other protocol defined exclusion criteria could apply

Keywords: m5717 plasmodium mutants acute malaria pyronaridine plasmodium falciparum polymerase chain reaction adequate clinical and parasitological response plasmodium eukaryotic translation elongation factor 2
the potential role of testosterone on target organ damage in postmenopausal hypertensive women

Conditions: Hypertension

Summary: the incidence of cvd-related deaths is generally higher in women than men. postmenopausal changes in estrogen/androgen ratio that induce a relative androgen excess have been proposed as important factors in the higher prevalence of hypertension. therefore, the investigators hypothesize that testosterone has potential role between hypertension and target organ damage in postmenopausal hypertensive women. and the objective is to evaluate the effects of testosterone between hypertension and target organ damage in postmenopausal hypertensive women.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of hypertension * women are all postmenopausal * men are matched with women. exclusion criteria: * secondary hypertension * coronary disease * heart failure * arterial fibrillation * previous myocardial infarction * previous stroke * malignant disease * kidney failure * liver failure * neoplastic disease * severe neurological diseases * severe metabolic or organic decompensation * refuse to sign the informed consent form

Keywords: hypertension female
whole-body diffusion mri for staging, response prediction and detecting tumor recurrence in patients with ovarian cancer

Conditions: Ovarian Carcinoma

Summary: the aim of this study is to assess whole body diffusion weighted imaging (wb-dwi) as a non-invasive method for * accurate staging of patient suspected having ovarian cancer * early treatment assessment * detecting tumor recurrence

1. staging --- (pet-)ct is used nowadays to provide imaging information about the disease burden of ovarian cancer patients and a diagnostic staging laparoscopy under general anesthesia is often necessary to allow correct and accurate staging. the applicant propose an "all-in-one" imaging modality providing high quality thoracic-abdominal images without using ionizing radiation and/or radioactive material. this allows accurate assessment of operability in a minimally invasive manner. 2. early treatment assessment --- although response to the first administration of chemotherapy is quite reasonable, most patients show tumor recurrence and achieve increasingly poorer response rates to second- or third-line regimes. therefore it is of major concern that a individualized prediction of chemosensitivity can be performed avoiding unnecessary toxicity from inefficient chemotherapeutic agents. a promising perspective is that the predictive data to be generated might prove to be sufficiently powerful to predict chemosensitivity early in the course of the treatment, facilitating a timely change of treatment in nonresponders. this could avoid unnecessary toxicity for patients, improving quality of life and moreover implicate considerable savings for the healthcare sector. 3. identifying tumor recurrence --- identifying tumor recurrence at an early stage could translate into reduction of unnecessary biopsies, cost savings and reduced morbidity associated with the biopsy procedure. but the most important issue is that early diagnosis can be life saving with respect to tumor recurrence.

Eligibility criteria:
inclusion criteria: * staging: patients with suspected ovarian carcinoma * early treatment assessment: patients with figo stage iiic or iv ovarian carcinoma who will undergo neoadjuvant chemotherapy * identifying tumor recurrence: patients with a medical history of ovarian carcinoma with suspicion of recurrent ovarian cancer after a disease-free-interval of at least 6 months exclusion criteria: * patients with known contra-indications for mri (cardiac pacemakers, cochlear implants, claustrophobic patients)will be excluded from this study. * patients with contra-indications to gadolinium-based contrast agents (including patients with a known restricted renal function; gfr \< 30 ml/min)and/or buscopan

Keywords: ovarian carcinoma staging early treatment follow-up identifying tumor recurrence whole body diffusion-weighted mri
pvp iodine effect on post debridement bacteraemia

Conditions: Bacteraemia Post Debridement

Summary: the study investigates the effect of supra- and subgingival rinsing of 10% pvp prior to ultrasonic debridement in patients with periodontitis (as compared to rinsing with water) in terms of post treatment bacteraemia. study design: randomized split-mouth (cross-over) study on 20 generally healthy subjects.

process: test treatment: * 1 min mouthwash with 10% pvp-iodine * 1 min subgingival rinsing with 10% pvp-iodine * 1 min ultrasonic debridement with 10% pvp-iodine as cooling liquid * blood sampling from the v.mediana cupidi control: * 1 min mouthwash with water * 1 min subgingival rinsing with water * 1 min ultrasonic debridement with water as cooling liquid * blood sampling from the v.mediana cupidi lysis, culturing and analysis of bacteria in the samples

Eligibility criteria:
inclusion criteria: * generally healthy, adult (≥ 18 years) patients with at least two periodontal pockets of ≥ 5 mm exclusion criteria: * pregnancy * lactation * allergy on pvp-iodine * anticoagulation (exception 100mg/d acetylsalicylic acid) * high risc for endocarditis * therapeutical radiation * participation in other clinical studies * cognitive impairment (patient unable to understand aim and conduction of the study

Keywords: bacteria bacteremia pvp-iodine periodontitis
development and validation of a prognostic score for early death in head injury patients.

Conditions: Traumatic Brain Injury

Summary: traumatic brain injury (tbi) is a serious condition with high morbidity and mortality. the glasgow score alone, assessed at the initial phase, is not enough to determine the prognosis. the aim of this study is to define and to evaluate a prognostic score for early death based on clinical and ct-scan findings in an observational retrospective derivation cohort of patients hospitalized for traumatic brain injury. this cohort will allow us to carry out a uni- and then multi-variate analysis so as to create a prognostic score for early death. we will subsequently test this score in a prospective validation cohort.


Eligibility criteria:
inclusion criteria: traumatic brain injury (pmsi code (programme médicalisation des systèmes d'information) s 06.70 and s 06.71) age\>14 years surviving more than 6h after the trauma hospitalized in the traumatic brain injury intensive care unit and managed in accordance with international guidelines who underwent a cerebral ct-scan exclusion criteria: ongoing treatment with anticoagulants or antiplatelets pregnant women persons without national health insurance cover children less than 15 years old under guardianship.
study of metabolic connectivity in drug-resistant temporal epilepsy

Conditions: Epilepsy

Summary: 18f-fluoro-deoxy-glucose (18f-fdg) positron emission tomography (pet) has a high sensitivity for temporal lobe epilepsy (tle), the most common form of focal epilepsy, with a detection range of 86-90% . therefore, 18f-fdg pet is a useful tool to identify the epileptogenic zone (etz) in the inter-ictal phase of drug-resistant temporal epilepsy during pre-surgical evaluation . based on stereotactic electroencephalography (seeg) findings, a correspondence between electrical data and metabolic changes on pet was found at the group level by identifying four different patterns of tle . as expected, hypometabolism was not limited to the ez defined by seeg, but underlay broader epileptic networks . because of the different electroclinical presentations of tle, 18f-fdg pet appears to be a very useful tool in these temporal epilepsies. indeed, it has been recently demonstrated that a gradient of pet hypometabolism from the uninvolved area to the spreading area, then to the epileptogenic area and to the lesion area is observed with consequently a good performance of 18f-fdg pet in defining the ez . therefore, it is interesting to study pet metabolism as a network and not as a combination of regional metabolic measures in epilepsy.


Eligibility criteria:
inclusion criteria: * patients with drug-resistant temporal epilepsy with an accurate diagnosis on seeg * patients with epilepsy who have had a pet/ct scan with 18f-fdg as part of a pre-operative assessment * person having received complete information on the organization of the research and not having objected to the use of these data; * patients affiliated to a social security system exclusion criteria: * person who has not received full information on the organization of the research and who has opposed the use of this data * a person of full age who is the subject of a legal protection measure (guardianship, curatorship, safeguard of justice). * a person of full age who is unable to give consent and who is not subject to a legal protection measure
personally-tailored opioid-overdose and medication for opioid use disorder (moud) education (tome) for pregnant and postpartum persons in moud

Conditions: Opioid Use Disorder; Pregnancy Related; Substance Use; Drug Abuse; Drug Abuse in Pregnancy; Drug Addiction

Summary: the primary objective of this study is to evaluate the ability of tome to increase medication for opioid use disorder (moud) and opioid-overdose knowledge in pregnant and postpartum persons.

this is an intent-to-treat, two-arm, open-label, randomized controlled trial. eligible participants will be randomized in a 1:1 ratio to tome or control, balancing on site. participants will receive the assigned intervention following randomization and will complete a three week follow-up assessment.

Eligibility criteria:
inclusion criteria: potential participants must be: 1. 18 years of age or older; 2. pregnant or be within 12 months postpartum; 3. enrolled in moud (either buprenorphine or methadone) at the study site or affiliated clinic where enrollment can be confirmed; 4. able to understand the study, and having understood, provide written informed consent in english exclusion criteria: potential participants must not: 1. have suicidal or homicidal ideation requiring immediate attention.

Keywords: ctn-0150 clinical trials network
validation of kelim as a predictive/prognostic factor for maintenance treatment with iparp in first-line ovarian cancer

Conditions: Ovarian Cancer

Summary: this study aims to understand whether it is possible to predict the effectiveness of maintenance treatment with parp inhibitors following first-line chemotherapy in ovarian cancer, and thus better target the patients who benefit from this treatment


Eligibility criteria:
inclusion criteria: patients randomised in the paola-1 study - exclusion criteria:opposition to the use of your data for research purposes. -

Keywords: parp inhibitor kelim maintenance treatment
exploratory clinical study of mt-2301

Conditions: Haemophilus Influenza Type b

Summary: the purpose of this study is to evaluate efficacy and safety of mt-2301 when co-administered with dpt-ipv using acthib® as a control in healthy infants.


Eligibility criteria:
inclusion criteria: * healthy infants aged ≥2 and \<7 months at the first vaccination of the study drug * written informed consent is obtained from a legal guardian (parent) exclusion criteria: * with obvious pyrexia (axillary temperature of 37.5ºc or higher) at vaccination of the study drug * with known serious acute disease * with known underlying disease such as cardiovascular disease, renal disease, hepatic disease, blood dyscrasia, and respiratory disease * with past diagnosis of immunodeficiency or currently under immunosuppressive treatment * history of anaphylaxis due to food or pharmaceuticals * with experience of hib infection, diphtheria, pertussis, tetanus, and acute poliomyelitis * with experience of hib vaccination, or administration of vaccine including either diphtheria, pertussis, tetanus, or polio as a constituent * history of convulsions * administered a live vaccine within 27 days before the first vaccination of the study drug, or inactivated vaccine or toxoid within 6 days before vaccination * administered transfusion, immunosuppressant (excluding drugs for external use), or immunoglobulin formulation * administered corticosteroid 2 mg/kg per day or more as prednisolone (excluding drugs for external use) continuously for more than 1 week * participated in other studies within 12 weeks before obtaining consent

Keywords: haemophilus influenza type b hib
transcutaneous auricular vagus nerve stimulation in dry eye disease with meibomian gland dysfunction

Conditions: Dry Eye

Summary: objective: to evaluate the effect of transcutaneous auricular vagus nerve stimulation (tavns) for the patients with dry eye disease with meibomian gland dysfunction. methods: we enrolled 270 patients at beijing tongren hospital. all treatments were self-administered by the patients at home after training at the hospital. patients completed questionnaires at baseline, 1 month, 3 months, and 6 months. osdi score, tbut, opas, npsi-eye, and schirmer i expressibility and secretion score to evaluate the therapeutic effects. a difference of p \< 0.05 was considered statistically significant.


Eligibility criteria:
inclusion criteria: 1. age \>=18 and age \<=65. 2. clinical diagnosis of dry eye disease with meibomian gland dysfunction. exclusion criteria: 1. history of depression, tumors, thyroid disease, diabetes, cardiac diseases. 2. history of otorhinolaryngology surgery. 3. pregnant or lactating women.

Keywords: dry eye,
brain derived neurotrophic factor serum levels evolution during the six months after alcohol withdrawal

Conditions: Alcohol Dependence

Summary: alcohol dependence is accompanied by several neurological mechanisms involving neuronal plasticity and neoneurogenesis, requiring brain derived neurotrophic factor (bdnf) synthesis. the investigators found that serum bdnf levels in alcohol-dependent subjects increased to a greater extent in subjects who had remained abstinent at 6 months after withdrawal than in subjects who had relapse. to verify if the bdnf serum levels variation is linked to the way that abstinence is installed, wthe investigators will measure bdnf serum levels in alcohol dependent subjects at the moment of withdrawal, and 14, 28 days, and 2, 4, and 6 months after to establish its evolution in relation to alcohol consumption, and other clinical characteristics : depression intensity, anxiety, alcohol craving, biological markers of alcohol consumption or toxicity. monitoring serum bdnf concentrations in link with other clinical data could help to characterize alcohol dependence profiles in clinical practice, help predict relapses, and assist in adjusting care to prevent difficulties in alcohol withdrawal.

a total of 205 patients will be recruited at their hospitalization time for alcohol withdrawal during a 18 months period. the follow-up at 14, 28 days, 2, 4, 6 months after alcohol withdrawal will assess their bdnf serum levels, the levels of carbohydrate deficient transferrin (cdt), gamma glutamyl transferase (ggt), urinary ethylglucuronide (etg), and the scores to the beck depression inventory (bdi), the montgomery asberg depression scale (madrs), the hamilton'anxiety scale (ham-a), the obsessive compulsive drinking scale (ocds).

Eligibility criteria:
inclusion criteria: * diagnosis of alcohol dependence according to the dsm-iv-tr * request for withdrawal exclusion criteria: * age \< 18 years * psychiatric co-morbidity in an evoluting stage and predominant on the addiction trouble * characterized (diagnosed) neurological co-morbidity * severe somatic pathology and / or with fatal predicted outcome in the year (cancer...) * inability to answer the questionnaires * pregnancy * neuroleptic or antidepressant treatment established for less than 3 months * anti-retroviral treatment * absence of consent, judiciary protection, hospitalization under constraint, - absence of health insurance. * residence at more than 80 km from the study center * participation to an other biomedical study during the 6 months of the study

Keywords: bdnf withdrawal alcohol psychiatry
postoperative painful chronicization after knee replacement surgery : exploratory study of bdnf's kinetics

Conditions: Total Knee Arthroplasty; Chronic Postoperative Pain

Summary: chronic pain is an extremely disabling disease. it is a major public health problem due to the lack of effective therapy. chronic postoperative pain (cpop) is defined by a painful symptomatology in the operated area unrelated to previous pain, present for more than 3 months, and without any link to surgical complication. the prevalence of chronicization of postoperative pain is 30% after total knee arthroplasty. identification of clinical, biological and psychological profiles are crucial to prevent cpop. a biologic factor, brain derived neurotrophic factor (bdnf) produced by a variety of cells is a key regulator of neuroplasticity. bdnf is increasingly studied in the mechanisms of cerebral sensitization and pain chronicization. the role of bdnf in pain of patients remains to be explored in a prospective study. the aim of this observational study is to compare the kinetics of bdnf after total knee arthroplasty in patients with and without cpop. patients will be included in the study at the preanesthetic consultation. serum bdnf levels will be measured preoperatively, 48h postoperatively, 3 and 6 months after surgery.


Eligibility criteria:
inclusion criteria: * social security affiliation * adult patients * signed informed consent * score asa (american society of anesthesiology) 1-3 * total knee arthroplasty exclusion criteria: * patient unable to exercise consent * pregnant women * vulnerable people * patients not included in the postoperative rehabilitation program * patients unable to complete the pain assessment questionnaires * chronic pain patients (other than knee arthrosis) * neuropathic pain patients (beforehand) * inflammatory diseases, progressive cancer, sepsis, immunosuppression known

Keywords: chronic postoperative pain brain derived neurotrophic factor
stabilometry after pressure release of the flexor digitorum brevis muscle versus a non-emission laser.

Conditions: Balance; Manual Therapy; Foot; Myofascial Pain Syndrome; Myofascial Trigger Point

Summary: in this study we will test the effects of pressure release on the flexor digitorum brevis muscle on stabilometric variables that support static equilibrium.

in this study we will test the effects of pressure release on the flexor digitorum brevis muscle on the stabilometric variables that support static balance. to test the effects on balance.

Eligibility criteria:
inclusion criteria: * healthy individuals * must have latent trigger point in flexor brevis digitorum muscles with no other pathologies. exclusion criteria: * previous lower extremities surgery. * history of lower extremities injury with residual symptoms (pain, "giving-away" sensations) within the last year. * leg-length discrepancy more than 1 cm * balance deficits (determined by oral questionnaire regarding falls)

Keywords: balance myofascial trigger point foot
reliability and reproducibility of the eye check tonometer

Conditions: Glaucoma; Glaucoma, Suspect

Summary: to investigate whether the new applanation tonometer (eyecheck monitor) can provide intraocular pressure (iop) measurements comparable to those of traditional tonometers such as the goldmann applanation tonometer and the tonopen.


Eligibility criteria:
inclusion criteria: * age of 18 years or older, * any glaucoma patient or glaucoma suspect patient * presents for an appointment wearing their own soft contact lens. exclusion criteria: * arthritis affecting the upper extremity in the patient or caregiver * patient unwilling or assessed to be unable to comply with the study protocol * any corneal abnormalities such as opacities, scars, fuchs dystrophy, map dot fingerprint dystrophy, history of recurrent corneal abrasion, corneal surgery such as lasik, prk, dsaek, transplant or implant * history of any ongoing ocular symptoms such as eye pain or redness or discharge * history of recent ocular surgery (done in the past 3 months) * history of a any filtering or tube surgery for glaucoma (to reduce risk of infection associated complications) * recent eye infection (within the past 3 months) * history of diabetes for \> 5 years duration * monocular patient * best corrected visual acuity\< 20/70 * head or hand tremors