Kornimate/medical-research-clean huggingface dataset:
evaluation of safety, tolerability, pharmacokinetics and pharmacodynamics of ta-8995 after multiple doses in healthy subjects

Conditions: Dyslipidemia

Summary: the purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of ta-8995 after multiple doses in healthy adult male subjects


Eligibility criteria:
inclusion criteria: * free from any clinically significant illness or disease as determined by their medical history, physical examination, laboratory and other tests and as judged by the investigator. * between 18 - 55 years old. * male of caucasian ethnic origin. * body mass index (bmi) in the range of 19 - 33 kg/m² and had a minimum weight of 50 kg. subjects with a bmi in the range 30.0 - 33.0 kg/m² had to have a waist measurement of ≤ 91 cm. exclusion criteria: * high density lipoprotein (hdl)-c level of greater or equal to 2.59 mmol/l (≥ 100 mg/dl) at screening. * abnormal electrocardiogram (ecg) at screening or day -1 including a qtc ≥ 430 ms (the qtc-interval was calculated automatically according to bazett's formula. in the case of results of ≥ 430 ms, qtc was additionally calculated manually using fridericia's formula which was used as an exclusion criterion). * family history of long qt syndrome, hypokalaemia or torsades de pointes * impaired endocrine, thyroid, hepatic, respiratory or renal function, diabetes mellitus, coronary heart disease or history of any psychotic illness * presence or history of gastro-intestinal, hepatic or renal disease or any other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs

Keywords: mt-8995 dyslipidemia cholesteryl ester transfer proteins
efficacy of a brief lifestyle intervention in type 2 diabetes, compared with a longer group educational program

Conditions: Diabetes Mellitus, Type 2

Summary: the study will compare two different programs for lifestyle intervention in type 2 diabetes: 1. a brief group program, with three weekly sessions 2. a longer group program, with six weekly sessions, which has been routinely used for the management of type 2 diabetic patients in this hospital for several years. the aim is that of demonstrating the non-inferiority of the new brief, and more sustainable, program, in comparison with the more traditional approach.


Eligibility criteria:
inclusion criteria: * type 2 diabetes * hba1c between 48 and 75 mmol/mol exclusion criteria: * axis i mental disorders * heart failure (nyha class iii or iv) * foot ulcers or lower limb amputations
epidemiology of injuries during crossfit practice

Conditions: Sport Injury

Summary: this study aims to precisely describe epidemiology of injuries than occur during practice of crossfit. each participant will complete questionnaires in order to identify injuries. the first questionnaire will be completed at the moment of the inclusion and the second questionnaire will be completed if participant has injuries every 3 months until month 12.


Eligibility criteria:
inclusion criteria: * person affiliated to a crossfit structure at reunion island at the beginning of the study * personne who agrees to participate in the study exclusion criteria: * person under tutorship or curatorship, * person whose the initial questionnaire initial is complete, * person who can neither read nor write french. * person planning to leave reunion island within 12 months after enrolment in the study
natural soybean-derived femarelle ®for patients with non alcoholic fatty liver disease

Conditions: Nash

Summary: this is a single -arm, open-label, before-and after exploratory trial of 90 days of femarelle ® to improve nafld and the metabolic syndrome. ingestion of femarelle will improve non alcoholic steatohepatitis and the metabolic syndrome in patients suffering from these conditions. subjects will receive treatment with femarele 530 mg (1 capsule twice a day) for 90 days and will then be monitored off study treatment for an additional 4 weeks.


Eligibility criteria:
inclusion criteria: 1. biopsy proven nash 2. if suffering from diabetes may be treated by up to 2 oral medications, with stable doses for 2 months. 3. if participating in sexual activity that could lead to pregnancy, the study volunteer must agree that two reliable methods of contraception will be used simultaneously while receiving the protocol-specified medication and for 1 month after stopping the medication. note: hormonal-based methods alone are not sufficient. at least two of the following methods must be used appropriately unless documentation of menopause, sterilization, or azoospermia is present: * condoms (male or female) with or without a spermicidal agent. - condoms are recommended because their appropriate use is the only contraception method effective for preventing hiv transmission * diaphragm or cervical cap with spermicide * iud * hormonal-based contraception study subjects who are not of reproductive potential (girls who have not reached menarche or women who have been post-menopausal for at least 24 consecutive months or have undergone hysterectomy and/or bilateral oophorectomy are eligible without requiring the use of contraceptives. written or oral documentation communicated by clinician or clinician's staff is required by one of the following: * physician report/letter * operative report or other source documentation in the patient record (a laboratory report of azoospermia is required to document successful vasectomy) * discharge summary * laboratory report of azoospermia * fsh measurement elevated into the menopausal range as established by the reporting laboratory. 4. ability and willingness of subject or legal guardian/representative to provide informed consent. exclusion criteria: 1. pregnancy or breast-feeding 2. continuous use of the following medications for more than 3 days within 30 days of study entry: * immunosuppressives * immune modulators * systemic glucocorticoids * anti-neoplastic agents 3. active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements. 4. serious illness requiring systemic treatment and/or hospitalization within 30 days prior to entry. 5. surgery within the previous 3 months. 6. any serious infectious, cardiac, pulmonary, or kidney disease 7. hypersensitivity to femarelle ® 8. malignancy of the uterus or breast 9. past thromboembolic event
effect of repetitive transcranial direct current stimulation (tdcs) on chronic pelvic pain

Conditions: Chronic Pelvic Pain; Interstitial Cystitis; Post Traumatic Stress Disorder; Fibromyalgia; Irritable Bowel Syndrome

Summary: we will rigorously test whether modulation of the motor cortex by transcranial direct current stimulation (tdcs) is an effective treatment for patients with chronic pelvic pain through the following specific aims: a) the primary aim of this study is to determine whether transcranial direct current stimulation applied to the motor cortex in patients with chronic pelvic pain induces a significant decrease in the pain or symptoms as compared with sham tdcs. we will also measure changes in the clinical symptom scores of multiple pelvic organs, drug intake (narcotic), anxiety, depression, traumatic stress, as well as overall improvement in the quality of life to assess the effects of this treatment. b) determine the duration of the clinical effects of tdcs. we will therefore compare the amelioration of pain and related symptoms between active and sham tdcs for one year following treatment. c) determine whether tdcs changes the threshold for pain detection as compared with sham tdcs. patients with chronic pelvic pain have a lower threshold for pain as compared to healthy subjects and we hypothesized that this threshold will increase after stimulation with tdcs. d) finally, we will examine whether 5 days of tdcs treatment is safe for use in chronic pelvic pain patients. safety will be assessed through neuropsychological tests and adverse event reporting.


Eligibility criteria:
inclusion criteria: * subjects must be females between 18 and 55 years of age. * subjects must have a current vas for pelvic pain of 5 or more. exclusion criteria: * known pelvic malignancy. * patients with major depression with suicidal risk as clinically defined. * patients with other known, uncontrolled neuropsychiatric disorders. * abnormal neurological examination other than as signs of the condition studied in the present protocol. * contraindication to tdcs: * a history of unmanaged substance abuse or dependence within the last 6 months. * a history of previous treatment with tdcs.

Keywords: vulvodynia painful bladder syndrome myofascial pain syndrome pelvic floor tension myalgia
iv methadone vs exparel erector spinae plane blockade in pediatric subjects undergoing idiopathic scoliosis correction

Conditions: Adolescent Idiopathic Scoliosis; Juvenile Idiopathic Scoliosis

Summary: the goal of this pilot study is to assess the feasibility of conducting a randomized controlled trial at a single institution comparing erector spinae plane blockade (espb) with liposomal bupivacaine (lb, exparel) to intravenous (iv) methadone for managing pain in pediatric subjects undergoing adolescent and juvenile idiopathic scoliosis correction. specifically, the goal is to enroll 15 subjects in each group and to complete data collection for all subjects. if this pilot study is successful, we plan to then design a larger scale study powered to compare specific outcomes between the two groups.

enrolled subjects will be randomized to one of two groups: one group will receive intra-operative iv methadone as the primary means of controlling post-operative pain while the other group will instead receive intra-operative erector spinae plane blocks (espb) with liposomal bupivacaine (lb, exparel) and bupivacaine hydrochloride as the primary means of controlling postoperative pain. all other aspects of peri-operative management will be standardized. subjects and the post-operative care team will be blinded to which intervention was performed in order to reduce bias. upon discharge, subjects will receive a wearable activity monitor and a daily journal in order to record post-discharge data. subjects will receive weekly phone calls for data collection and then will have a final in-person clinic visit, at which point participation in the study will conclude.

Eligibility criteria:
inclusion criteria: * subjects whose parent(s) or guardian(s) has/have signed and dated the informed consent form (icf) for the subject to participate in the study * patients with a diagnosis of juvenile idiopathic scoliosis (jis) or adolescent idiopathic scoliosis (ais) who will have posterior spinal fusion surgery * male or female patients 11 to less than 18 years of age on the day of surgery. * american society of anesthesiologists (asa) class 1-2. * able to adhere to the study visit schedule and complete all study assessments. exclusion criteria: * body mass index ≥35 at the time of screening * contraindication to regional anesthesia (e.g., abnormal coagulation, infection at site) * current opioid use at the time of screening * current diagnosis of chronic pain * allergy, hypersensitivity, intolerance, or contraindication to any of the study medications * administration of liposomal bupivacaine (lb, exparel) * subject/parent/guardian primary language other than english or spanish * inability of patient to verbally express symptoms such as pain and side effects (as in moderate to severe developmental delay) * a prolonged qtc on preoperative ekg (qtc longer than 450 milliseconds) * history of torsades de pointes * renal or hepatic impairment * diagnosed active seizure disorder * any other condition that causes patient to be ineligible for surgery, i.e. pregnancy.

Keywords: scoliosis methadone exparel regional anesthesia erector spinae plane block pediatric
persons with obesity (pwo) exploratory research

Conditions: Obesity

Summary: the purpose of this study is to understand the personal flow along the weight loss management journey. a range of variables will be addressed in a survey to explore the weight loss journey, barriers and management. topics include weight loss strategies and challenges, hcp involvement, and perceptions towards weight loss medications. potential participants will be recruited using various online panels. study participants will be recruited to participate in 2 types of qualitative research. phase i: online bulletin boards (obb) phase ii: virtual focus groups (real-time)


Eligibility criteria:
inclusion criteria: 1. informed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol). 2. male or female, age above or equal to 18 years at the time of signing informed consent. 3. current body mass index (bmi) of 25 or greater 4. not currently pregnant 5. does not participate in intense fitness or body building program 6. weight loss not through illness or injury 7. at least somewhat concerned about current weight 8. if no plans for weight loss in the next six months, has made at least 1 weight loss effort in last 5 years 9. struggling with weight for at least 3 years exclusion criteria: 1. previous participation in this study. participation is defined as having given informed consent in this study 2. mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation 3. does not meet inclusion criteria.
recovery learning for adolescents after traumatic experiences

Conditions: Posttraumatic Stress Disorder

Summary: most children who have been removed from their family home and placed under the care of a local authority have been exposed to many frightening experiences, including witnessing violence, not being fed or cared for, or being abused. these experiences can lead to significant emotional difficulties. one such difficulty is posttraumatic stress disorder (ptsd), which can involve symptoms like having constant "flashbacks" of scary experiences, and a constant feeling of being in danger. this can have a big effect on children's lives. yet, it is still not clear how to help young people in care who are experiencing high ptsd symptoms. one idea the researchers have is to use a group-based online programme which has successfully helped other young people who have been exposed to different kinds of stressful experiences (for example, war). to test whether this programme could help children in care too, the researchers first need to see whether social workers have the time to check in with a child about ptsd symptoms; whether young people and their carers are willing to be involved in a research project which will test out the treatment programme; and whether mental health workers might face any problems when delivering the programme. this project aims to answer these questions. the researchers will train social workers to complete an 8-question interview with 10-17 year olds in care, which will measure symptoms of ptsd. if the young person is experiencing high symptoms, they will be invited to take part in a research project. if they would like to join the project, children will be randomly selected to take part in the online group programme, or be given care-as-usual. the group programme involves the young person taking part in five weekly meetings held online, where they will learn skills to reduce their distress, and be supported to work through their difficult memories. their carers will also take part in two online meetings which will teach them how to support their young person.


Eligibility criteria:
inclusion criteria: * experiencing elevated ptss (using a standard cut-off score of =/\> 17 on the 8-item child revised impact of events scale; cries-8). * living in any care residence (with the exception of those living with a biological parent). * access to appropriate technology to engage in the online sessions and can do so in a quiet and private space. exclusion criteria: * a diagnosis of psychosis. * current and active serious suicidal ideations. * a moderate to severe learning disability. * currently receiving direct therapeutic mental health support.

Keywords: post traumatic stress disorder ptsd trauma foster care rct group
project accept: engaging newly diagnosed hiv+ youth in care

Conditions: HIV Positive Youth That Are Newly Engaged in Care

Summary: the proposed study is a two-group randomized repeated measures design that will examine the efficacy of project accept (adolescents coping, connecting, empowering and protecting together) to improve engagement in care among youth newly diagnosed with hiv at five amtu sites across the united states. youth will be randomized into one of two study arms; project accept, the intervention, or health, the health education attention-controlled comparison condition. both arms consist of two individual sessions followed by six group sessions and a final individual session which is expected to take approximately nine weeks after which youth will have four follow-up visits at the following time points: * post intervention (immediately after the last session); * 3 months post the last session; * 6 months post the last session; and * 12 months post the last session. the trial will be repeated in up to three waves.


Eligibility criteria:
inclusion criteria: * hiv-infected and aware of his/her status as documented by medical record review or verbal verification by provider (i.e., medical or mental health care provider, case manager, social worker, etc.); * received hiv diagnosis within the past 12 months (+ 3 months) at the time of consent/assent as documented by medical record review or verbal verification with referring professional (i.e., medical or mental health care provider, case manager, social worker, etc.); * between the ages of 16-24 (inclusive) at the time of informed consent/assent; * receives services at one of the selected amtus or one of their community partners; * willing to participate in both the individual and group sessions; * ability to speak and understand spoken english; * able to understand and willing to provide signed informed consent/assent in english or spanish; and * willingness to provide signed informed consent or assent with parental/legal guardian permission as applicable. exclusion criteria: * participated in a previous wave, if enrolling into wave 2 or 3; * intoxicated or under the influence of alcohol or other substances at the time of consent/assent; * visibly distraught and/or visibly emotionally unstable (i.e., exhibiting suicidal, homicidal, or violent behavior) in the opinion of the site personnel would interfere with the ability to give true informed consent; and * any concurrent participation in other behavioral studies. permission from the protocol team may be provided for uncertain cases.
effects of osteopathic management on disability and quality of life after lumbar arthrodesis

Conditions: Chirurgical Intervention

Summary: the aim of our study is to assess the effect of a combined physiotherapy and osteopathy treatment versus a placebo on the management of disability and quality of life after lumbar arthrodesis. this study will provide a better assessment of the use of osteopathy as a non pharmacological approach to post-operative management. for this purpose, we will analyze the effects of these two approaches, targeted and non-targeted osteopathy (to vs. nto), on patients' disability and quality of life after surgery.


Eligibility criteria:
inclusion criteria: * having experienced a lumbar arthrodesis (of one to three levels) four weeks before inclusion * being under a stable pharmacological treatment over the last month * who are suffering from postoperative mechanical pain (vas ≥ 4) exclusion criteria: * neuropathic pain according to a dn4 score greater than or equal to 4/10, * are suffering from fibromyalgia, * algodystrophy, * other somatic or neuropsychiatric diseases (other than depression and anxiety), * have received osteopathic treatment over the last three month prior to inclusion, * are included in another interventional research protocol during the study period
mobile app for mood in pregnancy (ginger io)

Conditions: Mood Disorders; Depression

Summary: the mobile mood tracking app study is a small randomized trial of acceptability and usability of a mobile phone mood tracking application (mobile app) among women with depressed mood in pregnancy. the study will be assessing the perceived value and usability of this tool in pregnancy over eight weeks to test whether women using this app are more likely to receive assessments and treatments of depressed mood than women not using it.


Eligibility criteria:
inclusion criteria: * positive screening for elevated depression symptomatology (phq-9 score must be greater than or equal to 5.) exclusion criteria: * women with pregnancies of less than 33 weeks gestation.
correlating noninvasive cardiovascular measures to left ventricular end diastolic pressure in heart failure

Conditions: Heart Failure

Summary: hf001 is a prospective observational study utilizing non-invasive medical devices that may be able to discriminate changes in heart failure while acutely decompensated patients undergo routine interventional therapies in a hospital setting. subjects will be monitored using cvinsight™ \[cvi\] via a finger and/or forehead sensor, while performing an isometric handgrip stress test (ihgst). changes in the cvi signal will be analyzed and correlated to standard assessments of heart failure including pulmonary artery catheter (pac) pressures, blood pressure (bp), patient symptoms, and physical exam findings. the results of this study will be used to develop a powered study to determine if a new configuration of non-invasive monitoring devices can be used to monitor heart failure status more sensitively than current non-invasive techniques.


Eligibility criteria:
inclusion criteria: * adult patients ≥ 18 years old * signs and symptoms of congestive heart failure including two of the following: * peripheral edema (e.g. abdominal distension, hepatomegaly, lower extremity edema) in the setting of elevated jugular venous pressure as assessed by the clinical examination, or by right heart catheterization. * pulmonary edema or pleural effusion as seen on chest x-ray * elevated n-terminal pro-brain natriuretic peptide (nt-pro bnp) 2x the upper limit of normal. * willing and able to comply with the study protocol * willing and able to give valid informed consent exclusion criteria: * pregnant patients * presence of left ventricular assist device (lvad) or heart transplant * complex congenital heart disorder or prosthetic valve on right side * known mitral stenosis * unstable medical condition or impairment other than condition associated with hf * unstable hypertension * too unstable in the judgment of the investigator to be included in the study * active lung infection or acute pulmonary decompensation * elevated white blood cell count and signs of infection are evident * does not have the cognitive ability to understand and sign the informed consent * does not have the cognitive capacity to perform handgrip test * is not able to perform a handgrip stress test * is not able to wear any of the devices * patient's life expectancy is less than 3 months