Kornimate/medical-research-clean huggingface dataset:
simplified cognitive behavioral therapy for generalized anxiety disorder and depression

Conditions: Generalized Anxiety Disorder; Major Depressive Disorder

Summary: this trial attempts to evaluate the treatment efficacy of simplified cognitive behavioral therapy (scbt) and its safety among schizophrenia patients. half of participants will be randomized to accept scbt.

the investigators have developed a simplified but standardized set of cognitive behavioral treatment (including the therapist's manual and patient self-help manual) for the patients of generalized anxiety disorder and depression, known as simplified cognitive behavioral therapy (scbt). scbt is the main psychological intervention of this study. the aim of this study is to verify its efficacy and applicability using a multi-center, randomized, placebo controlled and single-blind design, and to optimize the treatment program. the investigators hypothesize that scbt is effective in patients with depression or anxiety, and the manual is easily-operated for the therapists.

Eligibility criteria:
inclusion criteria: * 1. adults aged 18-60 years old, male and female; 2. with primary school or above education levels; 3. without vision, hearing or communication difficulties; 4. dsm-v diagnosis of generalized anxiety disorder and/or major depressive disorder; 5. hama-14 score greater than or equal to 14 points, less than 29 pionts; hamd-17 score greater than or equal to 7 points, less than 24 points; 6. gad-7 score greater than or equal to 5 points; phq-9 score greater than or equal to 5 points; 7. in the last 2 months, did not accept other forms of psychological treatment, or treatment is ineffective; 8. voluntarily participate in and sign informed consent. exclusion criteria: 1. suffering from serious physical illness; 2. having self-injurious behavior, suicidal tendencies; 3. having bipolar disorder; 4. having psychotic symptoms; 5. having obsessive-compulsive disorder, post-traumatic stress disorder; 6. pregnant women or lactating women.

Keywords: simplified cognitive behavioral therapy (scbt) generalized anxiety disorder depression operating manual efficacy
expanded access to ang1005 for individual patients

Conditions: Anaplastic Astrocytoma; Anaplastic Oligodendroglioma; Breast Cancer With Recurrent Brain Metastases; Leptomeningeal Carcinomatosis

Summary: this is an expanded access study with ang1005 treatment for two individual patients from protocol ang1005-cln-03 with who grade iii anaplastic astrocytoma and who grade iii anaplastic oligodendroglioma and one individual patient from protocol ang1005-cln-04 with recurrent brain metastases and leptomeningeal carcinomatosis.


Eligibility criteria:
inclusion criteria: 1. neurologically stable 2. karnofsky performance status (kps) ≥ 80 3. adequate laboratory results exclusion criteria: 1. radiotherapy within 3 months. 2. evidence of significant intracranial hemorrhage 3. nci common toxicity criteria for adverse effects (ctcae) v4.0 grade ≥ 2 neuropathy 4. inadequate bone marrow reserve 5. any evidence of severe or uncontrolled disease
aerobic training in patients with congenital myopathies

Conditions: Congenital Myopathy

Summary: congenital myopathies are clinical and genetic heterogeneous disorders characterized by skeletal muscle weakness. most patients experience muscle weakness and fatigue throughout their life. however, progression of symptoms is rare. there are no specific treatments for congenital myopathies. training has been shown to benefit several other muscle diseases with weakness, but the defect in congenital myopathies involves contractile proteins of the sarcomere, why the effect of training is uncertain in these conditions. the investigators will therefore investigate the effect cycle-ergometer training for 30 minutes, three times weakly, for ten weeks in 15 patients with congenital myopathy. another 5-10 congenital myopathy patients, who do not train, will serve as controls for the trained patients. the study starts and ends with a test day, where efficacy based on vo2max, performance in functional tests and a questionnaire will be assessed.

10 weeks of cycle-ergometer training at home. intensity at 70% of maximal vo2,max.

Eligibility criteria:
inclusion criteria: * danish patients with gene verified congenital myopathy exclusion criteria: * patients who are to week to train at a cycle-ergometer for 10 weeks * patients who have other health issues, which can disturb the interpretation of the efficacy

Keywords: congenital myopathy exercise
evaluation of two new medical instruments dedicated to the sentinel lymph node technique in case of breast cancer

Conditions: Breast Cancer

Summary: this project consists on the realization followed by the clinical validation of two medical instruments dedicated to the precise sentinel lymph nodes identification and localization in the case of breast cancer: an intra operative probe and an operative mini gamma camera. the sentinel lymph node technique, based on the propagation of cancer cells in the lymphatic system, allows a better evaluation of tumor staging, prognosis and therapeutic strategy determination. the goal of these instruments designed by physicians and physicists is to significantly improve the detection efficiency of the technique in order to reduce the false negative rate and then the recurrence risk, as well as the operative morbidity.clinical oncologist surgeons and fundamental physics applied to medical imaging researchers are involved in this project. the clinical validation of the medical instruments will be organized in the gynaecologic and obstetric department of the hospices civils de strasbourg with a series of 25 patients in the framework of a regular french protocol of clinical research.


Eligibility criteria:
inclusion criteria: * infiltrative breast cancer * no suspect axillary lymph node * no previous radiotherapy * no previous chemotherapy * no previous breast surgery

Keywords: sentinel lymph node breast cancer lymphoscintigraphy probe operative gamma camera breast cancer and sentinel lymph node biopsy use of lymphoscintigraphy use of intraoperative gamma camera use of intraoperative probe
pk/pd and clinial outcomes of beta-lactams in icu patients

Conditions: Critical Illness; Bacterial Infections

Summary: meropenem and imipenem are broad-spectrum carbapenem antibiotic and are frequently prescribed in critically ill patients with severe infections. these patients show several pathophysiological changes that may alter the carbapenem pharmacokinetic (pk) normally found in other populations. although the pk of carbapenems has been widely studied, most studies have been conducted on small populations, and clinical outcome data are sparse. therefore, the aims of this study are (i) describe the population pharmacokinetic parameters of meropenem and imipenem in critically ill subject (ii) evaluate the pharmacodynamic of meropenem and imipenem as a predictor of clinical treatment outcome.


Eligibility criteria:
inclusion criteria: * age \>18 years * severely ill patient who admitted to medical or surgical intensive care unit who require a treatment with meropenem or imipenem antibiotic exclusion criteria: * severe renal impairment and require renal replacement therapy * apache ii score \>30 * history of hypersensitivity to carbapenems * pregnancy or breast-feeding female

Keywords: pharmacokinetics pharmacodynamics meropenem imipenem
the significance of vitamin d storage in adipose tissue

Conditions: Obesity

Summary: the study will examine the role of adipose tissue in vitamin d physiology, particularly its role as a depot. the study is randomized double blind and placebo controlled.

vitamin d versus placebo will be given for 12 months. biopsies will be taken at baseline and every 6 month for 2 years. blood samples will be collected every 6th month. the study will thus give information on storage during vitamin d supplementation as well as use of vitamin d fat stores after stopping vitamin d supplementation

Eligibility criteria:
inclusion criteria: * healthy subjects exclusion criteria: * hypercalcemia * pregnancy * women without safe contraception
effect of ghrelin on sympathetic nervous system

Conditions: Healthy; Obesity

Summary: ghrelin is a newly discovered peptide that is secreted by the stomach. its main role is to stimulate food intake but recent studies indicate that it also acts on the cardiovascular system to confer beneficial effects. the mechanism of action is unclear but experimental studies suggest that ghrelin decreases the sympathetic nervous system. beside there is new evidence in animal models that ghrelin may also be involved in stress reaction as ghrelin injection seems to protect against symptoms of stress. given that circulating levels of ghrelin are reduced in obesity, this suggests that the effect of ghrelin may differ between lean and obese subjects. ghrelin could represent an attractive therapeutic strategy for the treatment of cardiovascular diseases. the aim of the study if to gain more knowledge of the effect of ghrelin on the sympathetic nervous system and stress reactivity in both lean and obese subjects.

this study will investigate the effect of intravenous administration of ghrelin on blood pressure, heart rate, muscle sympathetic nervous activity and baroreflex control in lean and obese individuals and will investigate whether ghrelin administration can influence the response to stress. both lean and obese individuals will be recruited and will receive an intravenous administration of ghrelin at increasing doses for 1 hour. their blood pressure, heart rate and sympathetic activity (small recording electrode in the peroneal nerve) will be recorded and subjects will be submitted to a mental arithmetic stress towards the end of the infusion. blood samples will be taken at regular intervals for various metabolic tests. these responses will be compared to those when submitted to saline infusion.

Eligibility criteria:
inclusion criteria: * healthy lean subjects with a bmi \< 25 kg/m2 and subjects with central obesity (according to idf definition) exclusion criteria: * any current medication * a history of diabetes * hypertension * cardiovascular, cerebrovascular, liver, thyroid disease * mental illness
phase ii double blind controlled trial of nigral grafting in patients with parkinson's disease

Conditions: Parkinson Disease

Summary: objectives: i. determine the effectiveness of fetal nigral transplantation in patients with parkinson's disease.

protocol outline: this is a placebo controlled, randomized, double blind study. patients are randomly assigned to 1 of 3 treatment groups. all patients receive 2 separate operations in which the substantia nigra from either 4 fetuses (group a) or 1 fetus (group c) is implanted into the striatum of each side. group b patients receive 2 separate placebo operations without fetal transplantation. the second surgical procedure begins approximately 1 week after the first operation. after 2 years, treatments are compared. if transplant is shown to benefit parkinson's disease, then patients who received placebo operation will be offered transplant surgery in the final year of the study.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- advanced parkinson's disease hoehn-yahr stage iv or worse during "off" periods hoehn-yahr stage iii or better during "on" periods predictable motor fluctuations with at least 20% of waking day in the "off" stage no atypical parkinsonism or secondary parkinsonism --prior/concurrent therapy-- biologic therapy: not specified chemotherapy: stable doses of levodopa/carbidopa or any other antiparkinson therapy for 2 months prior to study surgery: no previous intracranial/neurosurgical procedures --patient characteristics-- renal: creatinine clearance at least 70 ml/min or creatinine no greater than 1.8 mg/dl protein no greater than 300 mg/dl other: not pregnant or nursing adequate contraception required of fertile patients prior history of good response to levodopa no sensitivity to cyclosporine not hiv positive (e.g., hiv i or ii) no human t-cell leukemia/lymphoma virus (htlv-1) no tremors interfering with stereotactic surgery no clinically significant medical, neoplastic or infectious disease no clinically significant laboratory abnormality no dementia that precludes signing informed consent or score of less than 24 on mini-mental status examination

Keywords: parkinson disease neurologic and psychiatric disorders rare disease
evaluation of novel diagnostic tests for covid-19

Conditions: Acute Disease; Coronavirus; Respiratory Viral Infection

Summary: covid-19 (also known as coronavirus) originated in the wuhan china and has since spread to at least 159 countries around the world. it was declared a pandemic by the world health organisation on the 11th of march 2020. the cases in the united kingdom continue to increase exponentially with up to 5 683 people diagnosed as on the 22nd of march 2020. it is estimated that 1 in 5 people diagnosed will require hospital admission and 1 in 20 intensive care treatment. by developing and improving diagnostic testing, we can accurately diagnose infected cases to triage appropriate treatments, identify individuals for quarantine in order to prevent transmission and obtain information regarding patient's immune systems. at present, the diagnostic test is a highly specific method of genetic amplification called 'reverse transcription - polymerase chain reaction' or rt-pcr, which allows detection of very small amounts of genetic mutations caused by the covid-19 virus. however, this method must be completed in highly specialised facilities, which are few and far between, increasing time to diagnosis (currently 48-72 hours), increasing exposure to non-infected individuals, and overburdening the analysing facilities. the ideal solution is a point of care (poc) test that can give results immediately. this study aims to harness the point of care technology of the samba ii device (diagnostics for the real world ltd.), which is a ce-marked device that has been used with success in the identification of human immunodeficiency virus (hiv), by amplifying genetic material without the need to increase and decrease temperatures during the amplification process. in the covidx study, 200 patients meeting the public health england's (phe) inpatient definition of having suspected covid-19 will be approached, consented and a sample from throat and nasal swab (combined) or tracheal fluid taken and tested using the samba ii method. a combination of the standard phe rt-pcr and an additional validated laboratory pcr technique will be used as a control in line with standard clinical practice. patients will undergo an additional serum tests on existing samples as made available after routine clinical assessments to monitor antibody response. patients will be followed for clinical outcomes at 28 days post-admission.


Eligibility criteria:
inclusion criteria: * 16 years or above * patient requiring hospital admission and at least one of * clinical or radiological evidence of pneumonia * acute respiratory distress syndrome * influenza like illness (defined as fever \>37.8oc and at least one of the following respiratory symptoms, which much be of acute onset: persistent cough (with or without sputum), hoarseness, nasal discharge or congestion, shortness of breath, sore throat, wheezing, sneezing) exclusion criteria: * patients who have not had the standard phe covid-19 test applied * unwilling or unable to comply with research swab of nose \& throat or tracheal fluid

Keywords: coronavirus covid-19 ncov-2019
assessment of the effects of silk pillowcases on acne prone skin

Conditions: Acne Vulgaris

Summary: the purpose of this study is to determine the effects of using silk pillowcases in mild to moderate non-cystic acne prone skin in comparison to cotton pillowcases.

the investigators will evaluate acne severity/ lesion count, trans-epidermal water loss, and sebum production in participants. there is an equal chance of being assigned a 100% silk pillowcase or 100% cotton pillowcase.

Eligibility criteria:
inclusion criteria: * males and females between the ages of 15-45 years of age * the presence of mild to moderate acne vulgaris based on investigator global assessment * presence of at least 5 inflammatory lesions and at least 5 non-inflammatory lesions exclusion criteria: * the presence of severe acne as noted by investigator global assessment. * those who are unwilling to discontinue systemic antibiotics and benzoyl peroxide for 4 weeks meet the washout criteria prior to enrolling. * those who are unwilling to keep their facial regimen consistent throughout the study, and for 1 month prior to enrolling. * individuals who are unwilling to wash pillowcase every week using provided detergent. * use of isotretinoin within the three months prior to enrolment * individuals who primarily sleep on their back * current tobacco smoker or a tobacco smoking history of greater than 10 pack year * individuals on oral contraceptive pills or progesterone or estrogen containing therapies. * individuals who have changed any of their hormonal based contraception within 3 months prior to joining the study * individuals with known allergy or sensitivity to mulberry silk or cotton fibers in fabric

Keywords: acne non-cystic acne mild to moderate acne
a study to evaluate the add-on efficacy and safety of opicapone 50 mg or an extra dose of l-dopa 100 mg for the treatment of wearing-off in patients with pd

Conditions: Parkinson Disease

Summary: a study to evaluate the add-on efficacy and safety of opicapone 50 mg or an extra dose of l-dopa 100 mg for the treatment of wearing-off in patients with pd.


Eligibility criteria:
inclusion criteria: 1. diagnosed with idiopathic pd according to the uk parkinson's disease society brain bank clinical diagnostic criteria (2006) or according to the movement disorder society (mds) clinical diagnostic criteria (2015). 2. disease severity stage iii (h\&y staging) at on. 3. treated on a stable regimen for at least four weeks before screening with immediate-release l-dopa/ddci, three to four intakes per day, and up to maximum daily dose of 600mg l-dopa. 4. signs of wearing-off phenomenon with average total daily off-time while awake of at least 1 hour, including the early morning pre-first dose off (i.e. the time between wake-up and response to the first l-dopa/ddci dosage), despite optimal anti-pd therapy (based on investigator's assessment). exclusion criteria: 1. non-idiopathic pd (atypical parkinsonism, secondary \[acquired or symptomatic\] parkinsonism, parkinson-plus syndrome. 2. severe and/or unpredictable off periods, according to investigator judgment. 3. average total daily off-time while awake of \>5 hours, including the early morning pre-first dose off, despite optimal anti-pd therapy (based on investigator's assessment). 4. treatment with prohibited medication: entacapone, tolcapone, monoamine oxidase (mao) inhibitors (except selegiline up to 10 mg/day in oral formulation or 1.25 mg/day in buccal absorption formulation, rasagiline up to 1 mg/day or safinamide up to 100 mg/day), apomorphine or antiemetics with antidopaminergic action (except domperidone) within the last four weeks before screening. 5. previous or planned (during the entire study duration) deep brain stimulation or stereotactic surgery (e.g. pallidotomy, thalamotomy).

Keywords: comt inhibitor
evaluating for type-2 diabetes in the very early postpartum period

Conditions: Diabetes, Gestational; Prediabetic State; Glucose Metabolism Disorders; Diabetes Mellitus

Summary: pregnancy-associated diabetes, known as gestational diabetes mellitus (gdm), is associated with an increased lifetime risk of developing diabetes mellitus (dm) or pre-diabetes. up to 30% of women with gdm will continue have abnormal blood glucose tests 6 or more weeks after delivery. early diagnosis and treatment of continued impaired glucose metabolism or dm is essential because serious health problems can result. current guidelines recommend a 75-gram, 2-hour glucose tolerance test (gtt) 6 or more weeks after delivery for women diagnosed with gdm in order to identify those with continued dm or impaired glucose metabolism. however, approximately half of these women do not get glucose testing after delivery. the ability to test women while they are still hospitalized after having a baby could greatly increase diagnosis, care and treatment of women with abnormal glucose metabolism. our objective is to determine if a 75-gram, 2-hour gtt administered to women with gdm two to four days after delivery can identify those who will have an abnormal gtt at 6-12 weeks after delivery.

this will be a prospective cohort study conducted at winthrop-university hospital. women 18 years old or older who delivered a child or fetus within the previous 4 days at either hospital who also were diagnosed with gdm during the pregnancy will be eligible for participation. women will be excluded if they have issues that would interfere with administration of a gtt, are unable /unwilling to provide informed consent, or cannot follow up. anticipated enrollment will be 250 women at each study site. while still hospitalized two to four days postpartum, subjects will undergo a 75-gram, 2-hour gtt and have blood tested for hemoglobin a1c and glucose levels. they will be reminded to do the recommended gtt 6-12 weeks after delivery. maternal, neonatal, and obstetric characteristics will be collected, including the any gtt results. the results of the in-hospital gtt will be compared to the result of the gtt taken 6-12 weeks postpartum and tested for correlation.

Eligibility criteria:
inclusion criteria: * women 18 years old or older * delivered a child or fetus within the previous 4 days * diagnosed with gestational diabetes during the pregnancy exclusion criteria: * unable or unwilling to provide informed consent for the study * unable to undergo or complete a 2-hour oral glucose tolerance test 2-4 days postpartum * unable or unwilling to have study follow up.

Keywords: gestational diabetes postpartum glucose testing impaired glucose metabolism diabetes mellitus
phase iii extension study of efficacy and safety of ianalumab with or without study treatment withdrawal in participants with lupus nephritis (sirius-ln extension)

Conditions: Lupus Nephritis

Summary: the purpose of this 2-year extension study is the evaluation of the efficacy and safety 1. after study treatment withdrawal in patients with lupus nephritis (ln) who achieved response (complete renal response \[crr\] or partial renal response \[prr\]) on double-blind treatment at the end of the sirius-ln core study, and 2. of open-label ianalumab 300 mg treatment in patients who, at the end of the sirius-ln core study, were either already receiving ianalumab open-label treatment or did not meet crr/prr criteria on double-blind treatment at the end of the sirius-ln core study.

the sirius-ln extension study is a 2-year open-label extension study for participants who have completed the treatment periods (blinded treatment period-1 and blinded treatment period-2) of the sirius-ln core study on double-blind or open-label study treatment. investigators will use their clinical judgment to decide if it is beneficial for participants to continue with the extension study. in this extension study participants who achieve crr or prr status at week 140 will be withdrawn from study treatment and will maintain the soc medication as required. these 2 additional years in the extension study will allow to measure sustained remission, flares and safety off-study treatment. however, in the event of renal flares during the extension study, these participants who withdraw study treatment will have the option to receive open-label ianalumab.

Eligibility criteria:
inclusion criteria: 1. signed informed consent prior to participation in the extension study. 2. participants must have participated in the sirius-ln core study and must have completed the entire treatment up to week 144 on double-blind or open label study treatment. exclusion criteria: 1. use of prohibited therapies 2. pregnant or nursing (lactating) women.

Keywords: lupus nephritis (ln) b cell depletion ianalumab vay736