Kornimate/medical-research-clean huggingface dataset:
guanfacine for the treatment of post traumatic stress disorder (ptsd)

Conditions: Post-Traumatic Stress Disorder

Summary: this is a double-blind, placebo-controlled, randomized study lasting 8 weeks. purpose of the study is two-fold: first, to use a pharmacological agent to treat symptoms of ptsd, and second, to explore neurobiological mechanisms of action of guanfacine.

subject population is comprised of 100 persons with ptsd. 50 patients will receive guanfacine and 50 patients will receive a placebo. guanfacine is prescribed at 1 mg/day and may be increased to 2 mg/day. samples of plasma mhpg will be collected weekly. clinical ratings of ptsd anxiety and depression, as well as vital signs, will be assessed weekly. repeated measures analysis of variance will assess significance of main effect of drug, time, and drug by time.

Eligibility criteria:
* males and females, age 18-65 * diagnosis of ptsd from combat or civilian trauma * no major medical problems such as diabetes, cardiovascular disease * taking no psychiatric medication, or taking only one ssri antidepressant

Keywords: ptsd
cancer therapy-related cardiac dysfunction occuring in children treated by anticancer drugs for malignancies

Conditions: Malignancies; Cardiovascular Diseases; Children, Only

Summary: little is known about cancer therapy-related cardiac dysfunction occuring in children treated by anticancer drugs for malignancies. here the investigators use vigibase (http://www.vigiaccess.org/), the world health organization (who) database of individual safety case reports, to identify and describe cases of cancer therapy-related cardiac dysfunction associated with anticancer drugs.


Eligibility criteria:
inclusion criteria: * cases reported in the world health organization (who) database of individual safety case reports (vigibase) * related to children * and reported, or not, cancer therapy-related cardiac dysfunction exclusion criteria: * cases reported in the world health organization (who) database of individual safety case reports (vigibase) related to adult patients
an open-label, non-randomized, parallel group study in subjects with mild and moderate hepatic insufficiency and healthy volunteers

Conditions: Hepatic Impairment

Summary: multi-center, non-randomized, open-label, single-dose, parallel group study to determine the effect of impaired hepatic function on the pk of deferiprone and its 3-o-glucuronide metabolite following a single oral dose of 33mg/kg ferriprox®.

post-marketing study to evaluate the effect of impaired hepatic function on the pharmacokinetics (pk) of deferiprone and its 3-o-glucuronide metabolite and on the safety of ferriprox® in subjects with mild and moderate hepatic impairment as compared to healthy volunteers.

Eligibility criteria:
main inclusion criteria: all subjects: 1. adult males or females, 18 - 75 years of age (inclusive); 2. body weight ≥ 50 kg; 3. body mass index (bmi) between 19 and 32 kg/me2 (inclusive); 4. absolute neutrophil count (anc) of \>1.5x10e9/l ; healthy volunteers: 1. medically healthy with clinically insignificant screening results (e.g., laboratory profiles, medical history, vital signs, physical examination); 2. matched to hepatically impaired subjects in the study by age (+/- 10 years), sex and weight (+/- 15% bmi). hepatically impaired subjects: 1. considered clinically stable in the opinion of the investigator; 2. subjects with different degrees of impaired hepatic function as assessed by a child-pugh classification score: mild (class a: 5-6 points) and moderate (class b: 7-9 points) impaired hepatic function. main exclusion criteria: 1. for subjects with hepatic impairment, fluctuating or rapidly deteriorating hepatic function as indicated by clinical and/or laboratory signs of hepatic impairment (e.g. advanced ascites, infection of ascites, fever, or active gastrointestinal bleeding). 2. evidence of liver impairment in healthy volunteers: hepatitis b and c; or aspartate aminotransferase (ast), alanine aminotransferase (alt), bilirubin, clotting factors, serum protein that is considered clinically significant by the investigator; 3. history or presence of significant clinically unstable respiratory, cardiovascular, pulmonary, hepatic (except for subjects assigned to one of the hepatically impaired groups), renal, hematologic, gastrointestinal, endocrine (except for subjects with hepatic impairment with clinically stable and treated diabetes, hypertension and thyroid disorders), immunologic, dermatologic, neurologic, or psychiatric disease; 4. disorders or surgery of the gastrointestinal tract which may interfere with drug absorption or may otherwise influence the pk of the investigational medicinal product (e.g. resections of the small or large intestine, febrile conditions, chronic diarrhea, chronic vomiting, clinically unstable endocrine disease, severe infections, acute inflammations, etc.); 5. received a pharmacological agent in another clinical trial within 28 days prior to the first dose of the study;

Keywords: hepatic impairment liver impairment liver disease ferriprox® li dfp deferiprone
structured treatment interruptions in chronic hiv infection

Conditions: HIV Infection

Summary: in the last years structured treatment interruptions (sti) have been proposed to reduce haart-related toxicity and to increase patients' compliance. iss part is a randomized comparison of repeated stis versus continuous haart in chronically hiv-infected subjects with persistent suppression of viral replication. the two arms of the study will be compared in terms of immunological response (proportion of patients with cd4\>500/mmc) at 2 years.

patients are randomized in a 1 to 1 ratio to continue their current antiretroviral regimen (arm a) or to undergo structured treatment interruptions (sti) (arm b) according to the following scheme: stis of 1, 1, 2, 2 and 3 months each followed by a 3-month therapy period. during stis, therapy is resumed in the presence of an hiv-rna rebound \> 50,000 copies/ml or of a cd4+ t cell decline \> 25% of the baseline count (\> 35% for patients with cd4+ \> 500/mm3 at randomization). after the first cycle, subsequent stis are performed only if an hiv-rna level \< 400 copies/ml is reached after 2 months of therapy resumption. at the time of treatment interruptions patients in arm b who are on treatment with non-nucleoside reverse transcriptase inhibitors suspend these drugs first and continue the treatment with the other drugs of the combination for 3 days if nevirapine-treated and for 6 days in case of previous efavirenz-based regimen. patients are seen at the clinical site every three months for arm a and monthly for arm b. on these occasions, blood samples are obtained for biochemical and viro-immunological assessments. the toxicity grading scale of the aids clinical trial group (actg) is used for the reporting of clinical and laboratory adverse events. in arm b, plasma genotype is obtained in samples taken after 15 or 30 days of drug suspension. patients will discontinue the study in case of : early therapy resumption for 2 consecutive times (only arm b patients); acute retroviral syndrome (only for arm b patients); aids-defining event; severe adverse event; pregnancy; non-compliance; patient' s request; physician's decision.

Eligibility criteria:
inclusion criteria: * first-line antiretroviral therapy (3 or 4 drugs) for 6 to 18 months (one previous therapy change for toxicity or non-compliance is allowed) * hiv-rna level below 400 copies/ml for at least 6 months; * cd4+ count \> 350 /mm3; * pre-haart cd4+ \> 100/mm3 * no previous aids diagnosis. exclusion criteria: * previous antiretroviral therapy with 1 or 2 drugs (except arv prophylaxis in pregnancy) * pregnancy or breastfeeding * previous diagnosis of aids * grade 3 or 4 adverse event in the 15 days before enrolment * neoplasia * previous therapy with il-2, interferon (in the last 2 years) or experimental therapies

Keywords: hiv chronic infection clinical trial structured treatment interruption
live your life without diabetes

Conditions: Pre Diabetes

Summary: aim: to examine the effect of a brief theory-based health promotion intervention delivered in the community on health behaviour and diabetes-related risk factors among danish adults at high risk of diabetes. methods: a randomised trial was conducted among 127 individuals aged 28 to 70 with fasting plasma glucose: 6.1-6.9 mmol/l and/or hba1c : 6.0-\<6.5% (42- \< 48 mmol/mol) recruited from general practice in holstebro, denmark. participants were randomised to a control group or to receive the intervention delivered over four 2 h group sessions during five weeks, and two further sessions after one and six months. questionnaire data and clinical measures were collected at baseline, three months and one year after intervention.


Eligibility criteria:
inclusion criteria: * resident in the municipality of holstebro * aged \<70 years * a measurement of fasting plasma glucose: 6.1-6.9 mmol/l (the thresholds for impaired fasting glucose according to clinical guidelines) and/or hba1c : 6.0-\<6.5% (42- \<48 mmol/mol) within the previous six months. exclusion criteria: * none
evaluating high flow humidification therapy in patients with cystic fibrosis

Conditions: Cystic Fibrosis

Summary: this study is a single center, randomized pilot study to evaluate the clinical effectiveness of nasal high flow 20lpm humidification therapy in subjects with cystic fibrosis.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of cf * hospital admission for acute pulmonary exacerbation of cf (using fuchs criteria 4/10) * 10 years of age and older * subject is able to comply with the procedures scheduled in the protocol * signed informed consent form exclusion criteria: * receipt of any aerosolized experimental or investigational drugs within 1 month of enrollment * subject had ear, nose, and throat (ent) surgery, nasal bleeding, or nasal polyps within 6 months prior to study * subject is unlikely to comply with the procedures scheduled in the protocol * inability to give informed consent * subject requires supplemental oxygen * history of obstructive sleep apnea * history of pressure headaches requiring therapy within one month of enrollment * any other medical or psychological condition in which the study doctor(s) believe(s) would inhibit the individual from being an appropriate study subject.

Keywords: cystic fibrosis, high flow 20 liters per minute (lpm) humidification therapy
a clinical study of ono-1110 in patients with hunner type interstitial cystitis

Conditions: Hunner Type Interstitial Cystitis

Summary: to evaluate the efficacy and safety of ono-1110 in patients with hunner type interstitial cystitis


Eligibility criteria:
inclusion criteria: * japanese (both sexes) * age (at the time of informed consent): 18 years and older * outpatient * patients who are considered capable of understanding the study procedures and completing the pain diary, bladder diary, and questionnaires appropriately by the investigator (sub-investigator） * patients given a diagnosis of hic by cystoscopy * patients with chronic pelvic pain involving the bladder and lower urinary tract symptoms such as increased micturition and pollakiuria exclusion criteria: * patients with a history and presence of chemical cystitis * patients with a history of bladder augmentation or radical cystectomy * patients with pain other than hic that may affect assessments in this study * patients with a past history of or concurrent neurologic diseases that may affect assessments in this study * patients receiving medications for psychiatric disease

Keywords: ono-1110 ono-1110-06 hunner type interstitial cystitis
better understand motor deficits associated with autism spectrum disorders: development of an assessment protocol

Conditions: Autism Spectrum Disorder

Summary: this research is a case-control study aiming to characterize motor peculiarities (objective quantitative and qualitative measures) and its psycho-physiological correlates of children with asd.

the main objective is to measure jointly and in an automated and standardized manner the performance and motor patterns within the framework of tasks measuring the performance and patterns of general motor skills (postures, walking, coordination overall), fine motor skills (graphics, pointing task) and oculomotricity (visual orientation and control). the secondary objective is to investigate the relationships between motor difficulties and cognitive and social disorders found in children with asd. * compare the motor performance data in the 3 major motor domains with each other (overall, fine and oculomotor); * evaluate intergroup differences based on clinical characteristics (ados-2, adi-r, cars 2 scores), age, iq, socio-communication profile score (srs-2) and presence comorbidities (tadh, tdc).

Eligibility criteria:
inclusion criteria : all participants : * be between 6 and 11 years old * mastery of the french language * be affiliated with a social security scheme or benefit from affiliation by a third person * both parents (or the holder of legal authority) have read, understood and signed the study consent * be affiliated with social security participants with asd should also verify the following inclusion criteria: * being diagnosed with asd (dsm-v) exclusion criteria : all participants : * refusal to participate in the research on the part of the participant and / or holders of parental authority. * be a person benefiting from enhanced protection, namely : persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social establishment. * have uncorrected visual or hearing problems * to have concomitant psychotropic drug treatments not stabilized, initiated in the last 2 months: antipsychotics, mood stabilizers, anti-epileptics, psychostimulants, antidepressants. * have a motor handicap of the upper or lower limbs, fitted or not. * have diagnosed neurological or psychiatric disorders, present a general or metabolic pathology having a known impact on the child's motor skills (eg: epilepsy, tics and gilles de la tourette syndrome, intellectual deficiency, neuromuscular syndrome, metabolic neurological syndrome , neoplasms) * suspicion of low intellectual efficiency if at least one of the two subtests (similarities or matrices) of wisc v (retrieved from the medical file if the tsa participant) presents a result (standard score) strictly lower than 7. participants without asd : * participant with adhd (attention deficit disorder with or without hyperactivity) or cdd (developmental coordination disorder)

Keywords: autisme spectrum disorders motricity cognitive disorders behaviour motor skill differences
chemotherapy-induced peripheral neuropathy-essential oil intervention

Conditions: Breast Cancer; Peripheral Neuropathies

Summary: this study will evaluate an oil blend with active ingredients for the reduction in chemotherapy-induced peripheral neuropathy in people with breast cancer. half of the participants will receive the oil blend with active ingredients and the other half will receive a placebo (an oil blend with no active ingredients). one-fourth of the people will also take pictures of their life with chemotherapy-induced peripheral neuropathy.

chemotherapy-induced peripheral neuropathy (cipn) is a painful, debilitating consequence of cancer treatment and is considered the most adverse of non-hematologic events. current pharmacological approaches to reduce cipn symptoms can be ineffective and cause adverse effects. constituents of this oil blend moderate pain signal transmission through non-competing inhibition of 5-ht, ache, and substance p, along with antagonism of trpa1 and trpv1. this study will test the hypothesis that an oil blend reduces cipn symptoms and improves quality-of-life (qol) in breast cancer patients. the human response to illness model is used to underpin a convergent-nested-parallel mixed-methods design with intervention.

Eligibility criteria:
inclusion criteria: * diagnosis of breast cancer * chronic cipn symptoms in one or both lower extremities * three months or greater since last chemotherapy treatment * mean sf-mpq-2 score of greater than or equal to three * a prognosis of greater than six months exclusion criteria: * non-english-speaking * blindness * pregnancy * breastfeeding * allergy to eoi or peru balsam (cross-allergen) * illegal substance usage * history of severe skin reactions * non-intact skin on lower extremities * history of lower extremity trauma or amputation * current use of aromatherapy/essential oils * asthma or reactive airway disease triggered by constituents of eoi * history of mental illness or chronic depression * the following co-morbidities: g6pd deficiency, inherited peripheral neuropathy, active herpes varicella-zoster, herpes simplex virus, alcoholic neuropathy, repetitive stress or entrapment neuropathy, peripheral vascular disease, and multifocal mononeuropathy.

Keywords: breast cancer cipn pain qol essential oils
stress and insomnia

Conditions: Insomnia; Stress

Summary: insomnia is characterized by rumination and worry over stressful events affecting nighttime sleep. emotional reactions while stressful events are ongoing have not often been investigated in insomnia. in the current study stress reactions will be measured during a real-life simulation experiment with stressful events and investigate not only how previous sleep patterns affect emotional reactivity to the event but also how the emotional events affect sleep patterns the following night. thirty-six female subjects (age 25-45 years) without sleep complaints (n=18) or with insomnia (n=18) will enroll in a interventional study measuring the reaction to and effects of either neutral or stressful events during driving. through questionaires and intake polysomnography, clinical levels of depression and anxiety will be excluded as well as sleep medication use and alternative sleep disorders than insomnia. stress levels will be measured through skin conductance and heart rate variability during events and through nighttime polysomnography (psg). effects on sleep architecture and arousal levels will be measured through nighttime psg. investigators hypothesize that subjects with insomnia, compared to subjects without sleep complaints, show stronger emotional reactions to stressful events and stronger effects of stress on sleep quality the following night. results will facilitate a model for emotional reactivity in chronic sleep disruption which may aid to prevent short term sleep disruption converting into chronic insomnia and aid in developing customized insomnia treatment.


Eligibility criteria:
inclusion criteria: * insomnia group: patients with insomnia (dsm-v criteria): sleep complaints, of more than 3 nights a week, more than 3 months, affected daytime functioning * control group: no self-reported sleep problems * 20-50 years old * female * having given written informed consent to participate in the research project * driving license exclusion criteria: * night and shift-workers, * psychiatric disorder: clinical mood disorder, anxiety disorder, psychosis, bipolar disorder, * for insomnia group: all sleep disorders other than persistent insomnia, * for control group: all sleep disorders * progressive neurological diseases that include restless legs syndrome, * cardiovascular disease other than treated hypertension, * unstable respiratory or endocrinological diseases, * reporting symptoms of menopause and/or taking hormone replacement therapy for menopause symptoms, * drug addiction, alcohol addiction during the previous 6 months (smoking is allowed), * having undertaken trans-meridian travel (± 3h) in the previous 1 month, * pregnant or lactating women. * chronic pain. * having simulator-sickness during the first practice session * hypnotic and psychotropic medication taking or stopped less than 5 half-life periods of molecules before screening v0. * a change in skin conductance of less than 0.05 microsiemens after an auditory stimulus. * left-handedness * patient participating to any other interventional study

Keywords: insomnia stress real-life stressful events
topical tranexamic acid use on granulating wounds following mohs micrographic surgery

Conditions: Postoperative Wound Haemorrhage

Summary: bleeding after mohs micrographic surgery for skin cancer is a low risk complication that can occur. this study aims to determine the effect of a drug, often used to reduce bleeding, called tranexamic acid when applied topically to the skin wound after surgery.

to perform a prospective randomized controlled trial to determine the hemostatic effect of txa soaked gauze (intervention) versus normal saline soaked gauze (control) when applied to granulating defects in the setting of mohs micrographic surgery. patients meeting inclusion criteria will be randomized into two arms once enrolled in the study on the day of their mohs micrographic surgery (mms). one arm will serve as the control group and will receive normal saline soaked telfa pads to the wound bed upon completion of mms. a second arm will receive txa 25mg/ml at a volume of 1ml/cm2 soaked telfa pads to wound bed upon completion of mms. in both arms, the telfa pads will have a standard pressure dressing placed overtop.

Eligibility criteria:
inclusion criteria: * all adult (18 years or older) patients presenting for mohs micrographic surgery (mms) for the treatment of melanoma or nonmelanoma skin cancer (nmsc) with a wound that will be healing by granulation exclusion criteria: * patients must not be pregnant or breastfeeding. * patients must not have a known allergic reaction or sensitivity to txa * patient must not have an international normalized ratio (inr) out of therapeutic range if on warfarin.

Keywords: tranexamic acid hemostasis hemorrhagic complication bleeding complication mohs micrographic surgery granulating wound granulating defect