Kornimate/medical-research-clean huggingface dataset:
mental health telemetry for self-management in major depression

Conditions: Major Depressive Disorder

Summary: mood journaling is a cornerstone of self-management in major depressive disorder (mdd). research over the last decade has shown that electronic mood journals are superior to paper ones. one potential advantage of mental health telemetry (mht), which use cell phones to collect mood journal data, is that electronic journal data can easily be converted into graphical records, allowing people living with mdd to readily spot trends, correlations, or patterns in ways that would be quite challenging using paper diaries. this information should make it easier to recognize and evaluate changes in mental health status -- the first two steps in the process of self-management. the investigators will develop and deploy a visualization module for patients with which to explore their own mht data sets on the same cell phones which they record their journals, and test the investigators hypotheses that their enhanced mht system will (i) improve patients' ability to self-manage mdd and (ii) enhance their quality-of-life. the study is a non-randomized, un-blinded, a-b-a' (modified single-subject withdrawal design, with user choice of treatment or withdrawal in the a' stage) study, to explore the utility of mht as a tool for enhancing self-management and qol for persons living with mdd. the aims of this study are to explore the impact of mht on subjects' self-management and qol, and to gauge participants' perceptions of mht's utility.


Eligibility criteria:
we will recruit (n=113) patients with a diagnostic and statistical manual, 4th ed. (dsm-iv) diagnosis of mdd, confirmed using the mdd section of the m.i.n.i. international neuropsychiatric interview (mini) version 5.0. all recruits will own or use a web-enabled cell phone. exclusion criteria: * self-disclosed illiteracy; * blindness; * inability to be successfully trained in the use of mht

Keywords: psychiatry mental health major depressive disorder self-management data visualization mood diaries electronic diaries cell phones software mental health telemetry ecological momentary assessment
network of linoleic acid supplementation in cystic fibrosis

Conditions: Cystic Fibrosis

Summary: undernutrition is a common problem in patients with cystic fibrosis (cf) despite international consensus that the patients shall be given 120-200% of energy recommendations. studies imply that one problem might be that the patients are not compensated for the essential fatty acid deficiency (linoleic acid, la), which is well known in these patients. this deficiency is shown not to be due to fat malabsorption, but related to an increased turnover of arachidonic acid, a transformation product of la. this abnormality is related to mutations associated with a more severe clinical phenotype. the most common and typical symptom of la deficiency is poor growth. studies in animals have further indicated that many of the symptoms in cf are related to the deficiency. a series of recent prospective studies from wisconsin corroborate the importance of la for growth. in sweden la has been supplemented to most patients since the late 70´, and the condition of patients have been among the leading in the world regarding growth, pulmonary function and survival. short-term studies have shown better effect of la supplementation compared to similar supply of energy without including extra la. there are few long-term studies, performed before the gene was identified, giving very heterogeneous patient groups in regard to genotype, but with some positive results on growth and physiology. it´s of interest that modern personalized extremely expensive therapy with correctors and potentiators for cystic fibrosis transmembrane conductance regulator may influence lipid metabolism. la might thus tentatively be a cheap adjuvant to this modern therapy, but this has to be specially studied. the aim of the study is to find if there are differences in clinical and metabolic outcome between two groups, blindly given similar amount of extra calories, in one group consisting of linoleic acid.the benefit for the patients would be great if the expected positive effect can be proved in the planned study. the treatment will be cheap and without adverse effects. from socioeconomic point of view is would be a great advantage.

two group of matched children with cf were randomized to two type of oils given 20 g oil and 600 mg dha daily for one year and anthropometry, pulmonary function, biochemistry, resting energy expenditure, lipid mediators, inflammatory and intestinal markers were studied at start and at 6 months and 1 year. dietary intake was controlled and life quality recording at start and end of study.

Eligibility criteria:
inclusion criteria: * two mutations related to severe clinical status such as df508, or other stop mutations or class ii mutations. severe status includes pancreatic insufficiency exclusion criteria: * liver cirrhosis and/or portal hypertension, transplantation or on transplantation list, intake of lipid supplements the latest 2 months

Keywords: arachidonic acid, lipid mediators cytokines growth pulmonary function igf-1 resting energy expenditure docosahexaenoic acid
two different regimens of nolvadex in preventing gynecomastia induced by casodex 150 mg in patients with prostate cancer

Conditions: Prostate Cancer

Summary: the aim of the study is to investigate the efficacy of different dosing and scheduling of nolvadex in preventing gynecomastia/mastalgia induced by casodex 150 mg monotherapy in patients with prostate cancer.


Eligibility criteria:
inclusion criteria: * histologically confirmed prostate cancer * locally advanced prostate cancer patients suitable for casodex 150 mg monotherapy exclusion criteria: * age \> 75 yrs * no metastatic disease (m1). * no presence of gynaecomastia and/or mastalgia at screening * no therapy with medications able to provoke gynaecomastia and/or mastalgia within 6 months of trial entry.

Keywords: casodex monotherapy
safety study of cts21166 to treat alzheimer disease

Conditions: Alzheimer's Disease

Summary: this study is the first human exposure for the drug candidate cts21166 in healthy male volunteers


Eligibility criteria:
inclusion criteria: * healthy adult male \> age 21; * non-smoker (minimum 6 months); exclusion criteria: * history or evidence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic,neurologic, psychiatric, oncologic, or allergic (including anaphylactic drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease * history or evidence of intravenous illicit drug use, human immunodeficiency virus (hiv), hepatitis b, or hepatitis c; * participation in another clinical trial within 30 days prior to dosing
dietary treatment study of fat synthesis and risk of cardiovascular disease

Conditions: Overweight and Obesity

Summary: the purpose of this study is to find out how the amount of fat or sugar in a person's diet, or the number of meals eaten each day, affect the amount of fat that people's bodies make, the types of fats in the bloodstream, and how much fat is stored in the liver. the study is funded by the national institutes of health.

the study consists of two 10-day feeding periods that are separated by approximately two weeks. during each feeding period all food and beverages to be consumed will be provided by the study. in study 1, participants will be randomly assigned to receive one of two diets. both diets are designed to maintain weight at a constant level. the diets are balanced nutritionally and have the same amount of protein. one diet has higher amounts of sugar, while the other has higher amounts of fat. for one 10-day period, the diet will be fed as two large meals ('meal-feeding'). for the other 10-day period, the identical diet will be fed as 8 small meals ('nibbling'). half of the participants will meal-feed first, while the other half will 'nibble' first. the order of nibbling or meal feeding will be determined randomly. in study 2, the number of meals eaten per day will remain fixed at three (no nibbling or meal feeding). participants will receive both the diet higher in sugar and the diet higher in fat. however, they will be randomly assigned to start one followed by the other for each 10-day feeding period. at the end of each 10-day feeding period, participants will spend two nights in a research ward (clinical research center) to undergo testing.

Eligibility criteria:
inclusion criteria: * overweight or obese men and women * ages 20-65 years exclusion criteria: * pregnancy or lactation within the past six months * type 1 or 2 diabetes mellitus\] * ast and alt above upper limit of normal (uln) * fasting triglyceride or total cholesterol levels \>uln * hgb below the lower of limit of normal * positive hiv antibody test or hepatitis serologies * use of any antidiabetic medications or lipid-lowering drugs * history of surgery for obesity * change in body weight \>5% within preceding 6 months (self report) * claustrophobia, presence of metal implants * weight over 350 lbs

Keywords: diet sugar cardiovascular lipid
an investigational study of cyclosporine on experimental medication bms-986165 in healthy male participants

Conditions: Psoriasis

Summary: this is an investigational study of cyclosporine on the experimental medication bms-986165 in healthy male participants.


Eligibility criteria:
for more information regarding bristol-myers squibb clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * healthy participant, as determined by no clinically significant deviation from normal in medical history, physical examination, ecgs, and clinical laboratory determinations * body mass index 18.0 to 32.0 kg/m2 * weight ≥ 50 kg exclusion criteria: * any medical condition that presents a potential risk to the subject and/or may compromise the objectives of the study, including a history of or active liver disease * history or presence of acute or chronic bacterial, fungal, or viral infection (eg, pneumonia, septicemia) within the 3 months prior to screening * known or suspected autoimmune disorder, or any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status * history of administration of live vaccines within 60 days before screening * any history or risk for tuberculosis (tb) other protocol defined inclusion/exclusion criteria could apply
study of excretion balance and pharmacokinetics of [14c]-sar442168 in healthy male subjects

Conditions: Multiple Sclerosis

Summary: primary objective: to determine the excretion balance and systemic exposure of radioactivity after oral administration of \[14c\]-sar442168. to determine the pharmacokinetics of sar442168 and its contribution to the overall exposure of radioactivity. to collect samples in order to determine the metabolic pathways of sar442168 and identify the chemical structures and main excretion route of the main metabolites (samples will be analyzed according to metabolic analysis plan and results will be documented in a separate report). secondary objective: to assess the clinical and biological tolerability of an oral solution of sar442168.

total study duration is 3 to 10 weeks, including a screening period of 27 days, treatment period of up to 15 days and a follow-up and end of study of up to 4 weeks.

Eligibility criteria:
inclusion criteria : healthy male subjects 30 to 65 years of age. body mass index 18 up to 32 kg/m2, inclusive. signed informed consent. subjects must agree to the use of an adequate method of contraception for up to 3 months after discharge from the clinical unit exclusion criteria: radiation exposure exceeding 5 millisievert (msv) in the last 12 months or 10 msv in the last five years (including diagnostic x-rays and other medical exposures). occupationally exposure to radiation (as defined in the ionizing radiations regulations 2017). irregular bowel habits (more than 3 bowel movements/day or less than 1 every 2 days) . social habits: smoking, alcohol abuse, drug abuse etc. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
occipital nerve stimulation in trigeminal autonomic cephalgias

Conditions: Trigeminal Autonomic Cephalgia

Summary: the objective of this study is to determine the efficacy of occipital nerve stimulation (ons) in the treatment of chronic trigeminal autonomic cephalalgias (tacs).

several open studies and case series have shown improvement in pain scores using ons specifically for cluster headache, which is the most common of the tacs. however, neuromodulation in the treatment of pain disorders is subject to strong placebo effect and bias, and the lack of controlled studies in this population makes its true efficacy unknown. therefore, we plan to study ons in a population of patients with chronic tacs using a double-blind, randomized, controlled, cross-over study. using sub-threshold stimulation parameters, meaning patients will not know when therapeutic stimulation is active, subjects will rate their pain and quality of life during both therapeutic and sham stimulation periods. following the cross-over period, all subjects will undergo therapeutic stimulation for 1-year in order to gauge long-term effects.

Eligibility criteria:
inclusion criteria: * meets ichd-3 diagnostic criteria for the chronic form of one of the trigeminal autonomic cephalgias (outlined below), as determined by the treating neurologist. * failed standard medical management, meaning at least 3 conventional preventative therapies. exclusion criteria: * presence of uncontrolled or untreated psychiatric disease * presence of medical contraindications to surgery * patient does not consent to surgery * non-english speaking

Keywords: occipital nerve stimulation
neurocognitive communicator: safety study

Conditions: Motor Neuron Disease, Amyotrophic Lateral Sclerosis; Tetraplegia

Summary: individuals suffering from tetraplegia as a result of cervical spinal cord injury, brainstem stroke, or amyotrophic lateral sclerosis (als) cannot independently perform tasks of daily living. in many cases, these conditions do not have effective therapies and the only intervention is the provision of assistive devices to increase independence and quality of life. however, currently available devices suffer from usability issues and are limiting for both the patient and caregiver. one of the most progressive alternative strategies for assistive devices is the use of brain-computer interface (bci) technology to translate intention signals directly from sensors in the brain into computer or device action. preclinical primate research and recent human clinical pilot studies have demonstrated success in restoring function to disabled individuals using sensors implanted directly in motor regions of the brain. other preclinical primate research has demonstrated effective intention translation from sensors implemented in cognitive regions of the brain and that this information complements information from the motor regions. the current proposal seeks to build on these studies and to test the safety aspects related to implanting two sensors, each a microelectrode array, into both the motor and cognitive regions of the brain in motor impaired humans. secondary objectives include feasibility evaluation of the complementary sensors in their ability to support effective assistive communication.


Eligibility criteria:
inclusion criteria: * documented diagnosis of a complete or incomplete cervical spinal cord injury, with stable neurological deficits greater than 1 year, or als with equivalent degree of deficit. * maintain some level of communication, enough to independently provide informed consent for the study. * deemed healthy for surgery. * good psychological and social stability. * prospective participants with als must already have an advanced directive with regard to ventilation. * live within a one-hour travel duration of the site. exclusion criteria: * presence of previous certain implanted devices. * in the opinion of the investigator, the presence of other serious disease or disorder that could affect ability to participate in this study. * ongoing participation in another clinical trial. * individuals who are immunosuppressed or who have conditions that typically result in immunocompromise (eg. chronic corticosteroid use, immunomodulators, chemotherapy). * presence of clinical depression that is not medically optimized, as screened by a neuropsychologist on our team. * presence of cognitive deficits, as assessed by a neuropsychologist on our team, that would preclude completion of some cognitively challenging tasks. * the participant has plans to move outside the study radius within the study period.

Keywords: brain-computer interface brain-machine interface prefrontal cortex
pegylated interferon alone or in combination with ezetimibe for patients with chronic hepatitis d

Conditions: Hepatitis D, Chronic

Summary: ezetimibe possesses pharmacophore features to inhibit ntcp, the receptor required for hbv and hdv hepatocyte entry, that include two hydrophobes and one hydrogen bond acceptor. the aim of the study io evaluate the utility of ezetimibe in combination with pegylated interferon in patients with chronic hdv infection.


Eligibility criteria:
inclusion criteria: * presence of anti-hdv in serum * presence of quantifiable hdv rna in serum * elevated alt \> uln exclusion criteria: * decompensated liver disease * patients with alt levels greater than 10 times uln (400 u/l) * pregnancy or inability to practice adequate contraception. * significant systemic or major illnesses other than liver disease, including, but not limited to, congestive heart failure, renal failure (egfr \<50 ml/min), organ transplantation, serious psychiatric disease or depression and active coronary artery disease. * systemic immunosuppressive therapy * evidence of another form of liver disease in addition to viral hepatitis * active substance abuse, such as alcohol or injection drugs * hepatocellular carcinoma * concurrent hepatitis c infection or hiv coinfection * diagnosis of malignancy in the five years * concurrent usage of statins * concurrent use of any other drug known to inhibit ntcp * inability to understand or sign informed consent

Keywords: hepatitis d ezetimibe pegylated interferon
transmyocardial laser revascularization and cardiovascular magnetic resonance imaging

Conditions: Angina; Chest Pain

Summary: the primary goal of this study is to better understand how transmyocardial laser revascularization (tmr) affects the functioning of the heart and, in turn, relieves angina in individuals with coronary heart disease using magnetic resonance (mr) images and computed tomography (ct) images in some patients.


Eligibility criteria:
inclusion criteria: * male or female 18 years of age or over * patients with medically refractory, severe, class iii or iv angina based on the canadian cardiovascular society angina scale as determined by a physician * ejection fraction 25% or greater * patients with significant ischemia in the myocardium and who are not candidates for treatment by direct coronary revascularization methods (i.e., cabg or pci) * ability and willingness to consent and authorization for use of phi exclusion criteria: * patient cannot undergo a surgical procedure or general anesthesia * patient not eligible for cmr study * severe unstable angina * q-wave mi within 3 weeks prior to tmr * nqwmi within 2 weeks prior to tmr * decompensated heart failure (class iii/iv) at the time of procedure * known increased bleeding risk * implanted pacemaker or defibrillator * clinically unstable arrhythmia * not able or willing to adhere to the study tests and procedures * inability or unwillingness to consent and authorization for use of phi

Keywords: cardiac angina chest pain
aminosalicylic acid withdrawal study in long standing inactive ulcerative colitis

Conditions: Colitis, Ulcerative; Aminosalicylic Acid

Summary: the purpose of this study is to determine whether aminosalicylic acid (asa) can be safely withdrawn in patients with long-standing clinical inactive uc.

this is a randomized, double-blind, controlled trial in which patients with long-standing clinically inactive uc receiving asa for maintenance of remission will be randomized to either continue 5-asa or to receive an equivalent placebo for 12 months. the primary endpoint is clinical relapse at 12 months.

Eligibility criteria:
inclusion criteria: * have a confirmed diagnosis of uc according to established clinical, endoscopic and histologic criteria * in long-standing clinical remission * written informed consent exclusion criteria: * allergic to mesalazine * prior bowel surgery except appendectomy * hepatic or renal dysfunction * malignant disease within 5 years * pregnancy or breast feeding or women of child-bearing age without regular use of contraception * on anti-tumor necrosis factor therapy * terminal illness
electromagnetic stimulation of the phrenic nerve of intubated patients

Conditions: General Anaesthesia; Muscle Weakness

Summary: ventilator-induced diaphragmatic dysfunction is a common issue in critically ill patients. muscle stimulation has shown to have beneficial effects in muscle groups on the extremities. a non-invasive way to stimulate the diaphragm would be the electromagnetic stimulation but it is currently unclear if that is feasible. in this proof-of-concept trial the primary aim is to show that it is possible to induce a diaphragmatic contraction leading to an inspiration with a sufficient tidal volume via an external electromagnetic stimulation of the phrenic nerve.

during the time of first spontaneous breathing trial 60% of mechanically ventilated patients present with diaphragmatic weakness or also know as ventilator-induced diaphragmatic dysfunction (vidd). the damage to the diaphragm in terms of muscle atrophy has been shown as early as 12 hours after initiation of mechanical ventilation. recently, a correlation between diaphragmatic atrophy and mortality could be established. induction of diaphragmatic contractions via stimulation of the phrenic nerve would be a possible method to prevent or treat vidd. a possible modality would be the non-invasive electromagnetic stimulation but feasibility has not been established. in this proof-of-concept trial the primary aim is to show that it is possible to induce a diaphragmatic contraction leading to an inspiration with a sufficient tidal volume via an external electromagnetic stimulation of the phrenic nerve.

Eligibility criteria:
inclusion criteria: * ≥ 18 years of age * american society of anaesthesiologists classification i or ii exclusion criteria: * chronic lung disease * preexisting diaphragmatic weakness * neurologic disease with known motor weakness * paralysis of the phrenic nerve * contraindication for any movement in the cervical vertebrae * conditions that limit the movement of the diaphragm e.g. ascites, increased intraabdominal pressure, adipositas. * inability to communicate in the official language * infections, lesions or stricture in the neck area * implanted cardiac devices e.g. pace maker, defibrillator, event recorder * implanted medical pumps e.g. left ventricular assist device * metal implants in the upper body * preganancy

Keywords: vidd icuaw muscle weakness