Kornimate/medical-research-clean huggingface dataset:
combination of an investigational cannabinoid and methadone for hiv-associated neuropathy

Conditions: HIV-associated Neuropathy; Polyneuropathy

Summary: the purpose of this study is to evaluate the effectiveness of methadone alone and in combination with sab378 for the treatment of painful hiv-associated neuropathy.

distal sensory polyneuropathy is the most common neurological complication of hiv disease and its treatment. to date no standard effective therapy has been identified. in this study, scientists will evaluate the effectiveness of treating hiv-associated neuropathy with methadone alone and in combination with a novel cannabinoid sab378. a cannabinoid is a molecule found only in the cannabis plant. cannabis and some cannabinoids are effective analgesics or pain relievers. the rationale for combination therapy is twofold: (1) medications with unique mechanisms of action may affect different aspects of neuropathic pain and (2) combination therapy may act synergistically-meaning the combined effect may be greater than the effect of each drug alone. approximately 84 participants will be enrolled in this double-blind, placebo-controlled, crossover study. participants will be randomly assigned to three treatment groups-those receiving methadone and sab378 placebo (an inactive substance), those receiving methadone and active sab378, or those receiving methadone placebo and sab378 placebo. all participants will be exposed to each of the 3 treatment groups during the study. this trial is part of the neurologic aids research consortium, an effective collaborative clinical study group dedicated to the study of hiv-associated neurological disease.

Eligibility criteria:
inclusion criteria: * hiv-1 infection * hiv-associated neuropathy diagnosed by a neurologist * presence of at least a moderate pain score on the basis of completion of a baseline pain diary * stable antiretroviral regimen for at least 8 weeks prior to study entry. * hemoglobin ≥ 8.0 g/dl for males and ≥ 7.5 g/dl for females exclusion criteria: * active aids-defining opportunistic infection within 45 days prior to study entry * renal insufficiency * chronic liver disease * b12 deficiency * family history of hereditary neuropathy * discontinuation of dideoxynucleoside nrti within 16 weeks prior to entry * on neuroregenerative therapy * treatment with neurotoxic drugs within 120 days prior to entry * respiratory compromise * hypotension * active substance abuse or dependence * history of alcohol-related complications within 6 months prior to screening * women of childbearing potential

Keywords: hiv-associated neuropathy hiv aids cannabinoid cannabis methadone distal sensory polyneuropathy polyneuropathy
a pilot study on repetitive transcranial magnetic stimulation (rtms) treatment of bipolar depression

Conditions: Mood Disorder; Bipolar Disorder; Major Depression; Depression

Summary: this is a pilot project to study if repetitive transcranial magnetic stimulation (rtms) will benefit patients with bipolar depression safely. based on published studies, this study hypothesizes that rtms on the left dorsal prefrontal lobe will improve symptoms in some patients who have failed at least two medications.

candidate with bipolar depression will be screened after signing informed consent. those who meet the selection criteria will be treated with daily rtms for 3 weeks and be followed-up at 2 weeks. participants will keep their ongoing medication unless a medication significantly increases the possibility of seizure. they must be on the same dose of antidepressant medication for least 4 weeks without improvement of symptoms before being recruited into the study. mood and other observed mental status will be measured by standard psychological scales.

Eligibility criteria:
inclusion criteria: * bipolar i or ii patients, currently in a depression episode * patient must have failed at least 2 medication * score of 21-item hamilton rating scale for depression (ham-d) exclusion criteria: * rapid cycling bipolar or mixed episode of mood disorder by definition of current dsm criteria * substantial risk of suicide during the screening period that requires inpatient care * presence of psychosis * dual diagnosis of other primary, currently clinically significant severe mental disorders * history of other significant neurological diseases, such as seizure disorder, stroke, brain tumors, abnormalities in the blood vessels in brain, dementia, parkinson's disease, huntington's chorea or multiple sclerosis * history of any medical event that may increase the risk of having seizure, such as head trauma with unconsciousness for more than 5 minutes or a family history of seizure * significant medical complications that may deteriorate during the trial or have increased likelihood of danger consequences * patients who are pregnant or intend to become pregnant during the study period * any metallic prosthesis in head, neck or upper body (including cardiac pace maker) that cannot be safely removed during treatment * current vagus nerve stimulation (vns) treatment or electroconvulsive therapy (ect) treatment, or with history of failed ect treatment * patient's motor threshold for tms cannot be detected * significant side effects which are intolerable during the screening or any later stage of the trial * started psychotherapy within the previous 8 weeks or foreseeable psychotherapy will be started or changed in 6 weeks

Keywords: bipolar depression tms repetitive transcranial magnetic stimulation treatment efficacy safety
quality of life in lymphoma patients one year post-chemotherapy

Conditions: Lymphoma

Summary: malignant lymphomas are considered as among the most chemo-sensitive cancers. ml are cured in more than 85% of patient, the majority with complete response. after this active phase of treatment, patients are in "after cancer period". toulouse university hospital developed since 2006 the ambulatory medical assistance for after cancer program on lymphoma patient. ambulatory medical assistance for after cancer is very efficient for detecting physical and psychological complications which impact quality of life. the investigators identified 22% of lymphoma patients who had a reduced quality of life one year after the end of chemotherapy. the present study aims to investigate the evolution of observed complications and identify cancer care pathway which decrease the quality of life reduction risk in patients one year after lymphoma chemotherapy.

quality of life, as well anxiety, depression, social isolation, fear of cancer recurrence, post traumatic stress, will be measured in lymphoma patients, after a first line chemotherapy. care cancer pathway will be also evaluated. self-administered questionnaires will be performed on website (www.hospitalidee.fr) after inclusion and 12 months after.

Eligibility criteria:
inclusion criteria: * patients being in complete response after a first therapy for lymphoma * malignant lymphoma (hodgkin or non-hodgkin) treated by anthracyclines with a minimum of 6 cycles, followed or not by autologous hematopoietic stem cell transplantation * patients informed of the study and not opposed to the research exclusion criteria: * patients under legal guardian . * patients unavailable to formulate non-opposition to the study

Keywords: lymphoma quality of life cancer care pathway post-chemotherapy
the effect of telenursing interventions in empowering patients with copd

Conditions: Copd; Empowerment; Empowerment, Patient; Self Efficacy

Summary: the aim of this study is to evaluate the effect of telenursing interventions based on the empowerment model in empowering patients with copd.

patient empowerment is gaining importance and popularity day by day as it can be sustained through telehealth applications. the importance of using communication technologies in providing health care services has become more evident during the covid-19 pandemic. when integrated into healthcare, technology-centric services provide continuous and easily accessible health data for patients and help facilitate self-monitoring. with tele-nursing, copd patients can be strengthened in health literacy by teaching them how to access accurate and reliable resources. through tele-nursing, online support groups and forums can be created among copd patients so that patients can share their experiences with each other. in this way, social support is provided to patients who have to remain in social isolation due to their illness.

Eligibility criteria:
inclusion criteria: * having a confirmed copd diagnosis for at least one year * being literate, * having the cognitive and mental competence to answer questions, * being able to use a mobile phone, * disease symptoms are at a level that does not interfere with communication, * being in copd stage 2 and stage 3 according to the global initiative for chronic obstructive lung disease (gold: global initiative for chronic obstructive lung disease) criteria (30% ≤ fev1 \<80% (of expected)), exclusion criteria: * the disease is in the acute exacerbation period, * dyspnea is at a level that prevents cooperation, * having sensory loss regarding vision, hearing and speech, * refusal to sign informed consent forms * it is the refusal of the research to complete the data collection tools.

Keywords: telenursing empowerment pulmonary disease, chronic obstructive
cerebrospinal fluid cytology-guided intrathecal chemo-holiday therapy for egfr-positive nsclc leptomeningeal metastases

Conditions: Leptomeningeal Metastases

Summary: with the rapid development of targeted drugs, the treatment of patients with leptomeningeal metastasis has become a very difficult problem in clinical work. high-dose targeted drugs and intrathecal chemotherapy are important treatment methods for meningeal metastasis. however, it is vital to note that safety is also of concern in previous studies of intrathecal chemotherapy. in this study, we aim to evaluate the safety and effectiveness of patient using chemo-holiday therapy based on the cerebrospinal fluid cytology, combined with double-dose egfr-targeted drug in patients with leptomeningeal metastases from egfr-positive nsclc.

this is a single arm phase ii clinical trial. the objective of the study is patients with leptomeningeal metastases from non-small cell lung cancer after egfr tkis treatment. the pemetrexed is administrated by intrathecal injection with a dose of 50mg, once per week for 4 weeks, followed by every four weeks thereafter. the cerebrospinal fluid(csf) samples are collected every 4 weeks and the cytology examination will be performed. if csf cytology was negative, csf cytology was tested again 1 week later. two negative tests were considered as negative csf cytology. if the cytology of cerebrospinal fluid was negative after 4 consecutive intrathecal injections, the intrathecal injection should be stopped. if positive, continue to give a intrathecal injection every 4 weeks until csf cytology is negative. if csf cytological positivity or worsening of neurological symptoms occurs again during discontinuation, or if new symptoms appear, the intrathecal injection should be resumed every 4 weeks. in the meantime, double dose of vometinib (160mg) is given.

Eligibility criteria:
inclusion criteria: 1. male or female aged between 18 and 75 years. 2. histologically or cytologically confirmed diagnosis of nsclc with egfr mutations. 3. cytologically confirmed diagnosis of leptomeningeal metastasis. 4. normal organ function. 5. no history of severe nervous system disease. 6. no severe dyscrasia. exclusion criteria: 1. any evidence of nervous system failure, including severe encephalopathy, grade 3 or 4 leukoencephalopathy on imaging, and glasgow coma score less than 11. 2. any evidence of extensive and lethal progressive systemic diseases without effective treatment. 3. patients with poor compliance or other reasons that were unsuitable for this study

Keywords: leptomeningeal metastases egfr pemetrexed intrathecal injection vometinib
evaluation of the expression and functions of the kir3dl2 receptor and the anti-inflammatory activity of iph4102 in blood samples

Conditions: Axial Spondyloarthritis (axSpA); Ankylosing Spondylitis (AS)

Summary: the main objectives are 1. to study the pathophysiological role of kir3dl2 in axspa and its relationship with th17 immunity in hla-b27 + and hla-b27- patients and 2. to assess the effect on the pro-inflammatory immune response of a cytotoxic monoclonal antibody iph4102 (anti-kir3dl2) in these patients. the study will be carried out on blood samples from 24 patients with axspa, 12 hla-b27 + and 12 hla-b27-, without any drug injection nor direct therapeutic benefit for the participating patients and 12 healthy controls.


Eligibility criteria:
inclusion criteria: * informed consent of the patient signed before any procedure planned to the protocol * spa axial according to the criteria of the asas (international assessment of spondyloarthritis society) * known status hla b27 * disease activates with a score of basdai = 4/10. the basdai (bath ankylosing spondylitis disease activity score) is a composite indication(index), validated, used in the therapeutic essays and in current practice for the evaluation of the activity of the spa. * naive patients of thorough treatment * patients of 18 and more years old exclusion criteria: * minors * pregnant or breast-feeding women * adults under guardianship * people staying in a sanitary or social establishment * people in emergency situation * not profitable people of a national insurance scheme * private persons of freedom * treatment by corticoids during the last 30 days before the inclusion * treatment by anti-tnf or quite different biomedicine * treatment by sulfasalazine * reached concomitant by another active chronic inflammatory disease * infection chronicles by vhb, vhc or hiv * patients included in another study of clinical trial
changes in quality of life following surgical treatment of benign non-toxic goiter

Conditions: Goiter

Summary: the aim is to investigate the influence of surgical treatment on benign non-toxic goiter on the disease specific quality of life evaluated 6 months after thyroid surgery. all investigations follow already scheduled treatments.


Eligibility criteria:
inclusion criteria: * patients undergoing hemi- or total thyroidectomy for benign non-toxic goiter with pressure symptoms * the patients must be able to understand, read and write danish exclusion criteria: * previous surgery to the neck * diabetes or any neuromuscular disorders * present or previous head and neck malignancy, including malignancy found in the surgical thyroid specimen or suspicion hereof

Keywords: goiter thyroid disease struma
the co-op @ heartworks

Conditions: Congenital Heart Disease

Summary: this protocol is a research study involving human subjects diagnosed with congenital heart defects/disease (chd). the co-op @ heartworks is a cooperative between the research platform at heartworks and members of the chd community. individuals choosing to participate will be referred to as 'members' of the co-op. this study aims to create a database of members medical journey data to inform future clinical innovation and design of clinical trials which address the needs of the members. the knowledge generated from this study will help advance the care of chd patients through the deliberate action of the co-op @ heartworks members. unlike a traditional disease registry, the members of the co-op @ heartworks will actively inform and contribute to the future studies affecting their health.


Eligibility criteria:
inclusion criteria: * adult with a congenital heart defects/disease * caregiver of a minor with a congenital heart defect/disease * authorized family member of a now deceased person with congenital heart defect/disease exclusion criteria: - not having a congenital heart defect/disease

Keywords: hlhs congenital heart defect chd hypoplastic left heart syndrome
a phase i study of mk-2206 in combination with standard chemotherapy in participants with locally advanced or metastatic solid tumors (mk-2206-003)

Conditions: Locally Advanced, Metastatic Solid Tumors

Summary: the purpose of this study is to compare the safety and tolerability of several dose levels of mk-2206 in combination with chemotherapy and targeted therapy agents in participants with locally advanced or metastatic solid tumors. the primary hypotheses are that administration of mk-2206 in combination with either carboplatin + paclitaxel, docetaxel, or erlotinib in participants with locally advanced or metastatic solid tumors will have acceptable tolerability, a dose limiting toxicity (dlt) rate of ≤30%, plasma exposure and pharmacodynamics that exceed target thresholds, and allow for definition of a maximum tolerated dose (mtd) in each of the 3 combinations.


Eligibility criteria:
inclusion criteria : * participants must have locally advanced or metastatic solid tumors. * participant is male or female greater than or equal to 18 years of age. * participant must have a performance status less than or equal to 1 on the eastern cooperative oncology group (ecog) performance scale * female participants of childbearing potential has a negative serum or urine pregnancy test within 72 hours prior to receiving the first dose of study medication. * participants in the mk-2206 + carboplatin/paclitaxel and mk-2206 + docetaxel treatment arms will be limited to no more than 3 prior cytotoxic therapies for metastatic or recurrent diseases. * participant is able to swallow capsules and has no surgical or anatomical condition that will prevent the participant from swallowing. exclusion criteria: * participant has had chemotherapy, radiotherapy or biological therapy within 4 weeks. * participants must be least 4 weeks post-surgery and do not expect major surgery in the study duration. * participant is currently participating or has participated in a study with an investigational compound or device within 30 days. * participant has known active central nervous system (cns) metastases and/or carcinomatous meningitis. * participant with a primary central nervous system tumor. * participant has known hypersensitivity to the components of study drug. * participant has a history or current evidence of heart disease. * participant has evidence of clinically significant bradycardia (slow heart rate). * participant has uncontrolled high blood pressure. * participant at significant risk for hypokalemia (low potassium levels). * participant is a known diabetic * participant has known psychiatric or substance abuse disorders. * participant is a user of illicit drugs. * participant is pregnant or breastfeeding. * participant is human immunodeficiency virus (hiv) positive. * participant has known history of hepatitis b or c or active hepatitis a. * participant has symptomatic ascites or pleural effusion. * participant is receiving treatment with oral corticosteroids. * participant is using a potent cytochrome p(450) 3a4 (cyp3a4) inhibitor or inducer.

Keywords: tumors, cancer
special drug use investigation for lamictal bipolar

Conditions: Bipolar Disorder

Summary: this post-marketing surveillance study is designed to collect and assess information on safety and effectiveness of lamotrigine tablets in patients with bipolar disorder in routine clinical practice. ("lamictal" is a trademark of the glaxosmithkline group of companies.)


Eligibility criteria:
inclusion criteria: * patients with bipolar disorder * patients treated with lamotrigine tablets for the first time exclusion criteria: * not applicable
an observational study of pegasys (peginterferon alfa-2a) in patients with hbeag-positive or hbeag-negative chronic hepatitis b

Conditions: Hepatitis B, Chronic

Summary: this multicenter, prospective, observational study will evaluate the efficacy and safety of pegasys (peginterferon alfa-2a) in routine clinical practice in patients with hbeag-positive or hbeag-negative chronic hepatitis b. eligible patients receiving treatment with pegasys according to standard of care and the summary od product characteristics/local labelling will be followed for the duration of treatment and up to 2 years of follow-up.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 18 years of age * hbeag-positive or hbeag-negative serologically proven chronic hepatitis b with or without cirrhosis * elevated serum alt \> uln (upper limit of normal) but \</=10 x uln according to local label exclusion criteria: * contra-indications to pegasys as detailed in the label * co-infection with hepatitis a, hepatitis b or hiv * concomitant therapy with telbivudine (concomitant peginterferon alfa-2a therapy is contra-indicated according to telbivudine label) * pregnant or breastfeeding women
combined use of potassium nitrate gel and diode laser for dentin hypersensitivity

Conditions: Dentin Hypersensitivity

Summary: the aim of this clinical trial is to evaluate the efficacy of the combined use of a diode laser and a potassium nitrate-based desensitizing gel in reducing dentin hypersensitivity in adult patients. patients who meet the eligibility criteria and for whom informed consent has been obtained will be enrolled and assessed at five timepoints. at baseline (t0), all patients will undergo a professional dental cleaning, collection of medical and dental history, a full periodontal and dental charting, and completion of the dentine hypersensitivity experience questionnaire (dheq) to assess the impact of hypersensitivity on quality of life. sensitivity will be measured using the schiff air index and the visual analog scale (vas) in response to air stimulation. at t1, patients will receive the assigned treatment based on randomization. in the test group, the hypersensitive teeth will be treated with topical application of a potassium nitrate gel (emoform actisens, 5%) followed by irradiation with a 980 nm diode laser (1.5 w/cm² for 1 minute without contact, then 1 minute with contact and sweeping motion). in the control group, the same potassium nitrate gel will be applied, but the laser will remain inactive (sham laser). immediately after treatment, the schiff air index and vas will be reassessed. follow-up evaluations will be conducted at t2 (1 month after treatment), t3 (3 months), and t4 (6 months). at each follow-up visit, sensitivity will again be measured using the schiff and vas indices. at the final follow-up (t4), the dheq questionnaire will be administered a second time to assess changes in the patients' perceived impact of dentin hypersensitivity on daily life. patients are randomized into two groups: test group: potassium nitrate gel plus active diode laser (980 nm); control group: potassium nitrate gel plus sham diode laser (inactive). the study aims to determine whether the addition of diode laser irradiation enhances the desensitizing effect of the potassium nitrate gel in both the short and long term (from t1 to t4), as measured by changes in schiff air index, vas scores, and dheq results.


Eligibility criteria:
inclusion criteria: * patients with good oral hygiene * presence of at least one tooth affected by dentin hypersensitivity * signed informed consent exclusion criteria: * use of analgesic medication * ongoing orthodontic treatment * non-vital (endodontically treated) teeth * teeth with restorative materials on the surface * pregnant or breastfeeding women

Keywords: dentin hypersensitivity potassium nitrate diode laser dental pain desensitizing treatment visual analog scale schiff air index laser therapy tooth sensitivity noninvasive dentistry