Kornimate/medical-research-clean huggingface dataset:
a transdiagnostic internet intervention for parents of children with anxiety and depressive symptoms

Conditions: Emotional Problem; Anxiety; Depression; Psychological Distress

Summary: the purpose of this study is to evaluate the efficacy of a transdiagnostic, parent-led, internet-delivered intervention in reducing child and adolescent internalizing problems.

anxiety and depressive symptoms are common in children and adolescents. there is substantial research indicating that transdiagnostic internet interventions are effective for adults and children with anxiety and depressive disorders; however, there is limited research on the efficacy of such programs aimed at parents of children and adolescents with anxiety and depressive symptoms. this study aims to investigate the efficacy of a transdiagnostic internet intervention for parents of children with elevated anxiety and depressive symptoms.

Eligibility criteria:
inclusion criteria: * parent of a child/ adolescent aged 6 to 14 years * elevated internalizing problems * have internet access exclusion criteria: * undergoing psychotherapy/ pharmacological treatment

Keywords: internet intervention transdiagnostic parent-led intervention internalizing problems children rational emotive and behavioral therapy
online mbsr program for cancer survivors with chronic neuropathic pain

Conditions: Cancer; Painful Neuropathy; Chronic Pain; Worries; Pain or Disability

Summary: this randomized controlled trial will evaluate the effectiveness of an interdisciplinary treatment approach combining medical management with an online mindfulness-based stress reduction (mbsr) program in reducing disability and improving quality of life among cancer survivors living with moderate to severe chronic neuropathic pain.

chronic neuropathic pain (cnp) affects close to 50% of cancer survivors. even with the best medical treatment, some survivors continue to experience disabling pain. in our recent survey with cancer survivors, we found that the capacity to be aware of different aspects of one's day-to-day experiences, without judgment or reactivity (i.e., being mindful) predicted decreased pain intensity, pain related disability, and increased health-related quality of life among cancer survivors with cnp. building on these findings, the present randomized controlled trial will evaluate the effectiveness of an online mindfulness-based stress reduction (mbsr) program for cancer survivors with moderate to severe cnp. the program will benefit patients in rural and remote regions and patients with mobility issues. we will recruit 100 cancer survivors. all will have their medical treatment optimized by a pain specialist. additionally, they will complete an 8-week online mbsr program. we hypothesize that the online mbsr program will result in less pain perception, better function and increased health-related quality of life. we will also examine the effects of the mbsr training on biomarkers of stress and immune function.

Eligibility criteria:
inclusion criteria: * cancer survivors * experiencing cancer-related neuropathic pain symptoms for at least 3 months * pain severity ≥4/10 (moderate to severe) * ability to attend 7 out of 9 mbsr sessions * ability to complete questionnaires and attend sessions conducted in english or french * access to the internet and use of an electronic device capable of joining a video conference (i.e., computer or mobile device with a camera and microphone) exclusion criteria: * expected survival of less than 12 months * cognitive impairment * severe psychiatric disorder impacting ability to participate (e.g., schizophrenia, severe depression) * prior experience with mbsr

Keywords: mindfulness chronic pain quality of life immune function cancer survivors disability
antiepileptic drugs in elderly patients

Conditions: Seizure, Epileptic

Summary: the purpose is to study the population pharmacokinetics, effectiveness and safety of antiepileptic drug (phenytoin, carbamazepine, lamotrigine, levetiracetam, parempanel, etc) in elderly patients and recommend optimized dosage regimens.


Eligibility criteria:
inclusion criteria: 1. age ≥65 years old; 2. diagnosed with epilepsy; 3. using antiepileptic drugs for treatment; exclusion criteria: 1. patients who are expected to die within 48 hours; 2. patients with allergy to antiepileptic drugs; 3. patients receiving other investigational drugs; 4. other factors that the researcher considers unsuitable for inclusion.
the effect of ketone ester supplementation and ketogenic diet on brain plasticity in overweight/obese adults

Conditions: Overweight and Obesity; Cognitive Change; Psychophysiologic Reaction

Summary: this project comprises an initial crossover placebo-controlled neurophysiological study to ascertain the effect of acute ketone ester ingestion on motor cortex plasticity, followed by a second 2-week intervention study aimed to compare the effect of a ketogenic diet versus ketone ester supplementation on motor cortex plasticity, resting brain function and structure, and metabolic and neuroendocrine responses.

the study initially makes a bold attempt to explore whether the ketone supplementation would induce improvements in the overweight/ obese population's brain health via altering motor cortex plasticity, brain function and structure, and metabolic and neuroendocrine pathways. the study's aims include: * assessing changes in brain plasticity associated with excessive body weight and/or obesity. * evaluating the potential of ketone monoester supplementation in enhancing brain plasticity. * evaluating the potential of ketone monoester supplementation in correcting impaired brain plasticity due to excessive body weight. * evaluating the impact of short-term ketogenic dieting and ketone monoester supplementation on brain plasticity. * investigating structural and functional brain adaptations to short-term ketogenic dieting and ketone supplementation. * assessing the relationship between changes in brain plasticity and the brain's structural and functional adaptations and changes in circulating levels of brain-derived neurotrophic factors and key central acting hormones (i.e., insulin and leptin) due to ketogenic dieting and ketone monoester supplementation.

Eligibility criteria:
inclusion criteria: * body mass index (bmi) \> 25 and \ 18.5 and \< 25 kg/m2 (healthy weight group); * right-handed. exclusion criteria: * presenting any established counter indication for transcranial magnetic stimulation; * currently taking any medication affecting the central or the peripheral nervous system; * suffering from any psychiatric, neurologic, cardiovascular, or metabolic disease, including type 1 and type 2 diabetes mellitus; * undertaking surgery in the past six months; * engaged in resistance training. * pregnancy; * breastfeeding; * being amenorrhea.

Keywords: overweight obesity ketone neurocognition
low fat diet to prevent disease progression in patients with skin cancer

Conditions: Non-Melanomatous Skin Cancer

Summary: rationale: a low-fat, balanced diet may prevent disease progression in patients with nonmelanomatous skin cancer. purpose: randomized phase ii trial to study the effectiveness of a low-fat, balanced diet to prevent disease progression in patients with nonmelanomatous skin cancer.

objectives: i. determine whether intervention with a low-fat balanced diet will prolong the disease-free survival time in patients presenting with nonmelanomatous skin cancer and having a history of not more than two previous skin cancers. ii. assess the effect of this intervention on numbers of tumors during the two year follow-up period. iii. determine the incidence of new skin cancer in the control, nonintervention population. outline: this is a randomized study. patients are randomized into the dietary intervention or nonintervention groups. the control group has initial and follow up assessment of eating habits. the dietary intervention group also has initial and follow up assessment of eating habits that have been changed to reduce fat intake to one-half of the amount in the average american diet with a subsequent increase of carbohydrates to compensate for total caloric intake. both groups have assessment of clinical status of skin cancer at 4 month intervals for 24 months. patients are followed for two years. projected accrual: approximately 175 patients will be accrued in the first 3 years of this study.

Eligibility criteria:
disease characteristics: histologically confirmed basal cell carcinoma or squamous cell carcinoma of the skin no more than two prior skin carcinomas must not have genetic predisposition to skin cancer (i.e., xeroderma pigmentosum, basal cell nevous syndrome) patient characteristics: age: 15 and over race: caucasian performance status: not specified life expectancy: not specified hematopoietic: not specified hepatic: not specified renal: not specified other: no therapeutic diet that requires fat intake greater than 20% of total calories no untreated systemic malignancy no history of arsenic ingestion not diabetic prior concurrent therapy: biologic therapy: not specified chemotherapy: not specified endocrine therapy: no concurrent systemic steroids radiotherapy: no prior x-ray therapy for acne no prior/concurrent ultraviolet light (puva or uvb) therapy for psoriasis surgery: not specified other: no concurrent megavitamin or mineral supplementation at least 5 years since treatment with antimetabolites, folic acid inhibitors, alkalating agents, etc.

Keywords: basal cell carcinoma of the skin squamous cell carcinoma of the skin
audition after a lesion and in migraine. (auditionpostlesion)

Conditions: Migraine Disorders, Brain

Summary: the project studies auditory processing after brain damage (in temporal and/or frontal areas) and in migraine. the auditory processes investigated are attention, short-term memory, sound-induced emotions. to characterize auditory deficits after brain damage or in migraine, neuropsychological assessments are combined with neurophysiological markers (electro-encephalography: eeg, magneto-encephalography: meg, magnetic resonance imaging: mri).


Eligibility criteria:
inclusion criteria: * age from 18 to 80 * meg/mri compatibility * motivation to participate efficiently in the study * no severe hearing loss * informed consent to participate in the study * affiliation to social security * for brain-damaged patients : no need for medical assistance; focal temporal and/or frontal lesion; no major cognitive impairment; ability to understand and apply the instructions for neuropsychological testing; testing at least one-month after the event resulting in brain damage; absence of neurological and psychiatric disorders besides the lesion * for migraine patients: no need for medical assistance; migraine diagnosis; no major cognitive impairment; ability to understand and apply the instructions for neuropsychological testing; absence of neurological and psychiatric disorders besides the migraine * healthy participants: absence of neurological and psychiatric disorders exclusion criteria: * age below 18 or above 80 * mri scanning not possible: artificial cardiac pacemaker, insulin pump, metallic prosthesis, intra-cerebral clip, claustrophobia * meg acquisition not possible: large heads, neurostimulator, metal in the head or the body. * pregnant or breast-feeding women

Keywords: audition stroke migraine attention short-term memory, emotions eeg meg
melatonin's effects on treatment of diabetes mellitus

Conditions: Diabetes Mellitus

Summary: the aim of this study is to assess the efficacy and safety of melatonin in control of blood sugar in patients with type 2 diabetes mellitus (dm).

diabetes mellitus (dm) is a major public health problem with increasing worldwide incidence. the main causes for increase in incidence of dm are inactivity, obesity and changes of dietary habits. investigators think that the changes in the awake-sleep cycle may also contribute to higher incidence of dm in recent years. melatonin is an important component of the circadian system. numerous experimental studies have demonstrated that melatonin has many beneficial actions.melatonin is a potent antioxidant, reduces inflammatory process, lowers blood pressure, improve lipid profiles. collectively, these data suggest that melatonin may be useful in control of blood sugar in patients with dm. the aim of this study is to assess the efficacy of melatonin in control of blood sugar in patients with type 2 dm.

Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus diagnosed by an endocrinologist for more than six months * fbs=120-160mg/dl * hba1c\<8% exclusion criteria: * melatonin sensitivity * impaired fasting glucose (ifg) * impaired glucose tolerance (igt) * under insulin therapy * pregnancy * lactation * diabetic autonomic neuropathy and orthostatic hypotension * renal failure (creatinin\>1.5mg/dl) * diabetic retinopathy * diabetic nephropathy * malignancy * alcohol use * liver disease

Keywords: diabetes mellitus melatonin blood glucose therapeutics pineal gland
repetitive transcranial magnetic stimulation in irritable bowel syndrome

Conditions: Irritable Bowel Syndrome

Summary: the purpose of this study is to evaluate the efficacy of repetitive transcranial magnetic stimulation (rtms) on rectal hypersensitivity in patients with irritable bowel syndrome (ibs) in a prospective, randomized, double-blind study.

ibs patients frequently demonstrate a rectal hypersensitivity which could participate to the abdominal pain. rtms is an effective treatment of neurogenic chronic pain. the aim of the study is to evaluate the efficacy of rtms on rectal hypersensitivity in patients with ibs in a prospective, randomized, double-blind study. patients and method: 20 patients with rectal hypersensitivity secondary to ibs will have one active session of rtms located on the cortical area of the abdominal muscles during 5 consecutive days and one session of simulated rtms during 5 over consecutive days corresponding to the placebo session. the order of the two session will be randomized. the efficacy of rtms will be assessed by a rectal barostat to determine the pain or discomfort threshold and by a riii reflex. the barostat and riii reflex will be performed at the beginning and at the end of each session. the investigators hope to demonstrate an improvement of the rectal hypersensitivity during the active stimulations compared to the placebo one.

Eligibility criteria:
inclusion criteria: * more than 18 years old * ibs defined by rome iii criteria * rectal hypersensitivity evaluated by barotat with a pain or inconfort volume less than 28 mmhg * ibs for more than 3 months * with an organic exploration for less than 6 months * without any knowledge concerning the rtms exclusion criteria: * pregnant women or women without any contraception * patients with pace-maker or other metallic implant * patients complaining of epilepsia or with past of epilepsia * patients with psychiatric disorders * patients treated by any drugs which could interfere with rtms * patients having participate to another protocol within the month preceeding the inclusion * patients who could not stop the antalgic drugs within the week preceeding the onset of the study * patients with a significant lesion on rmi.

Keywords: ibs - rectal hypersensitivity - rectal barostat - rtms.
a study of bpi-452080 in subjects with solid tumors

Conditions: Solid Tumor; Renal Cell Carcinoma; Von Hippel-Lindau Disease

Summary: this open-label phase 1 study will evaluate the efficacy and safety of bpi-452080 in patients with solid tumors


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed locally advanced or metastatic solid tumor patients, who had disease progression after standard therapy, intolerable to standard therapy, refuse to standard therapy or for whom no standard therapy exists * dose expansion phase: arm1：has locally advanced or metastatic ccrcc and has progressed during treatment with at least one prior therapeutic regimen arm2：von hippel-lindau disease-associated clear cell renal cell carcinoma arm3：other solid tumors * adequate organ function * evaluable lesion required for dose escalation phase and at least 1 measurable lesion required for dose expansion phase exclusion criteria: * has received prior treatment with another hif-2α inhibitor * inadequate wash-out of prior therapies described per protocol, which may include anti-tumor therapies, tumor adjuvant drugs, organ or stem cell transplantation, moderate or strong cyp3a inhibitor or inducer, etc * patients with major surgery within 4 weeks, severe or unstable systemic disease, unstable/symptomatic cns metastasis, other malignant tumors, ild, clinical significant cardiac disease, bleeding or embolic disease, active infectious disease, or other medical or psychiatric condition that might interfere with participation in the trial or interfere with the interpretation of trial results, in the opinion of the investigator or medical monitor * pregnancy or lactation
gastric electrical stimulation (ges) for the treatment of obesity

Conditions: Obesity

Summary: the purpose of this feasibility study is to provide safety data on the implantable exilis gastric electrical stimulation (ges) system, to individually adjust stimulation parameters to levels that are comfortable for implanted subjects during chronic daily treatment, and to collect data on acute gastrointestinal function and food intake responses to ges during in-clinic testing.


Eligibility criteria:
inclusion criteria: * adults ages 21-64 with bmi of 40-45 kg/m\^2 or bmi 35-39.9 kg/m\^2 with at least one obesity-related comorbidity, who have failed prior non-surgical weight loss attempts, and have been within 5% of their current weight for at least one year. * if diabetic, subject has non-insulin-dependent type 2 diabetes mellitus diagnosed within the last 7 years, and has an hba1c level less than 8%. * if female and of child-bearing age, subject is not pregnant or lactating and is willing to use effective contraception for the duration of the study. * subject is willing and able to complete scheduled study visits, complete on-line lifestyle educational modules, and complete required procedures. exclusion criteria: * subject has a history of medical, surgical, or psychiatric conditions that, in the opinion of the investigators, would limit study participation or contraindicate implantation of the exilis ges system. examples includes cardiac abnormalities contraindicating surgical anesthesia, prior gastrointestinal surgery, gastrointestinal motility disorders, inflammatory bowel disease, a history of eating disorders, anticipated future need for magnetic resonance imaging, or allergies to food ingredients in study test meals.
efficacy of pentoxifylline and rifaximin combination in pentoxifylline refractory clinical and subclinical hepatopulmonary syndrome

Conditions: Hepatopulmonary Syndrome

Summary: * the study will be a prospective open labelled double blinded randomized controlled study. * the study will be conducted on patients admitted to department of hepatology from 2012 to 2014 at institute of liver and biliary sciences, new delhi * patients diagnosed as having clinical or subclinical hepatopulmonary syndrome will be started on oral pentoxifylline therapy 400 mg thrice daily for 12 weeks. * patients not responding to this therapy will be given divided into 2 arms with one arm receiving additional tab rifaximin 400 mg thrice daily or placebo for 12 weeks.


Eligibility criteria:
inclusion criteria: 1. evidence of portal hypertension (esophagogastric varices or portal hypertensive gastropathy identified on esophagogastroduodenoscopy, and/or varices seen on computerized tomography scan or ultrasound, and/or splenomegaly with no other explanation, and/or ascites with no other explanation) 2. intrapulmonary vascular dilatations (ipvds) diagnosed on contrast echocardiogram (ce) 3. aado2 \> 15 mm hg on standing room air arterial blood gas (abg) 4. ability and willingness to give informed consent exclusion criteria: * age \ 64 * intrinsic significant cardiopulmonary disease * inability to perform pulmonary function tests * moderate to severe pulmonary hypertension * advanced hepatic encephalopathy * inadequate echocardiographic window to allow for accurate transthoracic contrast echocardiography * antibiotic use within the last one month * listed for liver transplant in next 4 weeks * current use of exogenous nitrates * active bacterial infections * known malignancy * known intolerance to pentoxifylline or rifaximin
exploratory study on global reflexology in sickle cell disease

Conditions: Sickle Cell Disease (SCD)

Summary: sickle cell disease (or sickle cell anemia) is the most common genetic disease in france with 586 children screened in 2019. this chronic disease is characterized by the presence of abnormal hemoglobin (hb) s and a deformation of the red blood cells which take the elongated shape of a sickle and become more rigid and more fragile. sickle cell disease manifests itself among other things by very painful vaso-occlusive crises (voc) and for some chronic pain. their management is an emergency and often requires hospitalization. despite analgesic treatment, some patients have persistent pain. in 2013, a childcare assistant trained in canadian global reflexology emc offered reflexology sessions to 12 sickle cell patients. she observed a relief in all patients with a decrease in the pain score in 8 of them. these sessions seem to show us a double interest: the reduction of the child\&#39;s pain and the emergence of a technique that can be used by paramedics in the context of their own role. the investgators hypothesize that global reflexology is an effective and acceptable complementary technique for pain management in addition to the usual analgesic management in sickle cell children under 18 years of age in cvo. in order to verify our hypothesis, the investigators propose to explore the practice of canadian global reflexology as an innovative therapeutic option complementary to drug treatments in the hospital management of sickle cell children.


Eligibility criteria:
inclusion criteria: * patient under 18 years of age * patient suffering from sickle cell disease * patient hospitalized in the uhcd or usc unit of the women\&#39;s mother and child hospital of the hospices civils de lyon for the management of a cvo * informed consent signed by at least one holder of parental authority * collection of the patient\&#39;s assent as soon as his age allows it. exclusion criteria: * patient with pca (patient controlled analgesia) * patient with nca (nurse controlled analgesia) * patient not affiliated to a social security scheme or beneficiaries of a similar scheme.

Keywords: reflexology pain sickle cell disease
double blind controlled trial of an extensively hydrolyzed formula with a probiotic vs. an extensively hydrolyzed formula without a probiotic

Conditions: Allergy

Summary: the purpose of this study is to confirm the hypoallergenicity of an extensively hydrolyzed formula with an added probiotic in children with documented milk allergy.


Eligibility criteria:
inclusion criteria: * ≤14 years of age * essentially asymptomatic for a minimum of 7 days pre-challenge. * successful previous consumption of extensively hydrolyzed formula within 1 week of study enrollment * medically documented allergy to cow's milk exclusion criteria: * presence of underlying systemic disease or other illness * used beta-blockers within 12-24 hours of challenges * use of short-acting antihistamines within 3 days * use of medium-acting antihistamines within 7 days * use of long-acting antihistamines within 6 weeks * use of oral steroid medication within 3 weeks

Keywords: confirmed milk allergy