Kornimate/medical-research-clean huggingface dataset:
role of frontal cortex in the pathophysiology of gilles de la tourette syndrome (gts)

Conditions: Tourette Syndrome

Summary: tourette's syndrome (ts) is a debilitating and severe syndrome whose pathophysiology remains unclear. in order to precise the cortical regions involved in the generation of tics, investigators will realize an electroencephalogram (eeg) recording in the frontal cortex of ts patients in ecological conditions (eeg-holter). activity changes will be correlated with event markers of tics and neurovegetative parameters. statistical analyses will be compared between epochs of eeg recording with tics and without tics. the aim is to define the cortical regions involved in the genesis of tics in order to consider new targets for cortical stimulation.

gilles de la tourette syndrome (gts) is a childhood-onset disorder characterized by the presence of multiple motor tics and at least one vocal tic often associated with psychiatric co-morbidity. the expression of tics range from brief, recurrent and non-rhythmic motor or vocal actions (simple tics) to complex motor or vocal sequences (complex tics). the pathophysiology of tics is not yet fully understood. recent imaging data suggest that the pattern of functional connectivity in cortico-basal ganglia networks is disrupted in gts patients and could reflect a defect in brain maturation. however, regions involved in the immediate genesis of tics remains unknown since it is difficult to capture on line the cortical changes associated with tic generation using imaging techniques due to moving artefacts. moreover, tics are much more frequent in everyday life conditions than in the artificial conditions of a laboratory. the aim is to study cortical activity changes occurring before tic occurrence by using long duration recording of encephalographic activity (eeg) in ecological conditions through holter eeg techniques (24h recordings). recordings will be performed in 15 patients with a severe form of tourette's syndromes. eeg changes will be correlated to event markers, voluntary monitored by patients or automatically recorded (accelerometers for motor tics). eeg epoch centered on tics will be compared to similar epochs without tics. the occurrence of tics will also be correlated with neurovegetative markers of emotions such as rr interval ecg variability and skin resistivity changes. the ultimate goal of this project is to define a potential therapeutic target of tics for chronic cortical stimulation.

Eligibility criteria:
inclusion criteria: * tourette's syndrome since at least 2 years * lack of psychiatric comorbidity of axis 1 (depression) * y-ysgt score \> 20 * social insurance in accordance with the french law exclusion criteria: * epilepsia * patient with an implanted medical device * severe mental or somatic disease * risk of suicide, * pregnant or breast feeding women * patient under "curatelle" or "tutelle" * patient hospitalized no social insurance
combined sertraline and ketoprofen administration in major depressive disorder

Conditions: Major Depressive Disorder

Summary: among the major depressive disorder (mdd) patients in the follow-up group, 16 were administered with 50 mg of oral sertralin once daily with placebo, whereas 28 were treated with 100 mg of ketoprofen once daily as adjuvant treatment for mdd. controls do not take any medicine.

the research is a prospective, 2-month, double-blind study of parallel groups of patients with mdd with or without ketoprofen administration in addition to sertralin. 1. patients: a total of 140 patients with mdd (78 male and 62 female; aged 18-65 years) participated in the study. two samples were obtained at the beginning and 2 months after treatment from 34 patients that were followed up for two months after treatment. the samples were collected from "the psychiatry unit" at al-hakeem general hospital in najaf governorate-iraq from november 2016 to august 2017. patient samples were also obtained from a private psychiatric clinic that was run by an assistant professor in psychiatric medicine. the patients were diagnosed by psychiatrists in accordance with a semi-structured psychiatric interview schedule for mdd diagnosis based on the 10th revision of the international statistical classification of diseases and related health problems. the full medical histories of the patients were evaluated such that any existing systemic disease that may affect the parameters to be diagnosed, particularly diabetes, liver disease, and renal disease, were excluded. patients with histories of these diseases were excluded from the study. serum c-reactive protein (crp) was negative in all of the samples (crp\<6 mg/l). this test was conducted to exclude the presence of any overt infection or inflammation that may elevate acute-phase-reactant proteins, especially crp. the protocol was approved by the irb of the university of kufa. the patients or their close first-degree relatives provided informed consent in accordance with the procedures outlined by the current irb. among the patients in the follow-up group, 16 were administered with 50 mg of oral sertralin once daily with placebo, whereas 28 were treated with 100 mg of ketoprofen once daily as adjuvant treatment for mdd. 2. controls: as part of the control group, 40 apparently healthy subjects (22 males and 18 females) were selected. their sex and age were matched with those of the patients. these subjects were apparently free from psychiatric and somatic diseases.

Eligibility criteria:
inclusion criteria: * the patients were diagnosed by psychiatrists in accordance icd10 as having major depressive disorder. * the patients had no existing systemic disease that may affect the parameters to be diagnosed. * patients with negative serum c-reactive protein (crp\<6 mg/l). exclusion criteria: * patients with any systemic disease particularly diabetes, liver disease, and renal disease * patients with positive crp * patients who taking any other drugs

Keywords: major depressive disorder sertraline ketoprofen
safety and effectiveness and effect on quality of life and work productivity of humira in patients with psoriatic arthritis in clinical routine

Conditions: Psoriatic Arthritis

Summary: safety and effectiveness, quality of life and work productivity of humira in patients with psoriatic arthritis in clinical routine.

the primary objective of the non-interventional study is to explore the therapeutic success, measured by improvements in the following target variables (with regard to the respective baseline value): * the number of missed working days * the self-assessed workability * the severity of clinical symptoms (number of tender and swollen joints, c-reactive protein and erythrocyte sedimentation rate respectively; total score disease activity score 28, psoriasis area and severity index) * the severity of functional impairment (health assessment questionnaire) * the health-related quality of life . all of the patient and disease characteristics which are documented at baseline will be evaluated for their additional impact on the target variables (therapeutic success). particularly the impact of previous biologic therapies on clinical target variables will be evaluated. the secondary objective is to document the therapeutic success by the following variables: * the number of physician visit * the number and duration of hospitalization * the number of days of impairment in non-occupational activities * pain, exhaustion/fatigue * the reduction of number and dose of concomitant medication * patient's assessment of adalimumab therapy compared to previous therapies. target parameters for safety evaluation of adalimumab are: * the evaluation of safety and tolerability by the documentation and analysis of serious adverse events (saes) and adverse events (aes) * evaluation of safety and tolerability for subgroups of patients with common frequent concomitant diseases, especially diabetes type ii, cardiovascular, liver, and renal insufficiencies, and related concomitant medications.

Eligibility criteria:
inclusion criteria: * active and progressive psoriatic arthritis in adults with insufficient response to prior basic therapy exclusion criteria: * hypersensitivity against the drug or one of the other ingredients * active tuberculosis or other severe infections (e.g. sepsis and opportunistic infections) * moderate to severe cardiac insufficiency.

Keywords: psoriatic arthritis long-term observation humira safety effectiveness quality of life work productivity
the relationship of rehabilitation therapy time to the prevention of burn scar contracture

Conditions: Burns

Summary: this project will develop a descriptive database of patient information and patient outcomes. this database will be used to determine the association of time spent in rehabilitation and patient outcomes, to relate patient acuity to burn scar contracture development and to establish minimal time requirement guidelines for various rehabilitation patient outcomes.


Eligibility criteria:
inclusion criteria: * 18 year of age or older * admission for primary diagnosis of cutaneous burn injury * anticipated length of stay equal to/greater than five days * \>2% deep partial thickness burn or hand burn (which may be less than 2% deep partial thickness burn) exclusion criteria: * non-survivable burn as determined by the attending burn surgeon * electrical burn injury

Keywords: burn rehabilitation
effects of hyperbaric oxygen therapy on surgical wound healing

Conditions: Edema; Ecchymosis

Summary: the aim of this study is to test the effect of hyperbaric oxygen therapy) hbot (100% oxygen; 2.0 ata; 90 minute total exposure) and compare against a hyperbaric sham treatment (hbst) (patient's breathing room air; 2.0 ata; 90 minute exposure) in reducing edema and ecchymosis. hbot will be applied as a single pre-operative and a single post-operative treatment for patients undergoing eyelid surgery. briefly, patients will be exposed to hbot 2-4 hours prior to undergoing surgery, 2-4 hours post-surgery and healing will be assessed at day 3, 10, 21, 30 \& 90 days after surgery. edema and ecchymosis will be assessed in a time series to determine the extent that hbot reduces these clinical signs. the primary null hypothesis to test will be that no differences in scores will exist between treatment and control at day 3, 10 \& 21 post-surgery. a secondary null hypothesis to test is the time required to change a score will be no different between the two groups. hbot=hyperbaric oxygen therapy; hbst=hyperbaric sham treatment


Eligibility criteria:
inclusion criteria: * patients that are able to undergo surgery at the allure clinic are capable of undergoing exposure to hbot, as the contraindications of hbot are similar to eyelid surgery, with few exceptions. exclusion criteria: * the investigators will exclude active smokers and those who have quit smoking in the last 12 months, those with known lung disease, seizure disorder, congestive heart failure, known active cancer, previous treatment with specific chemotherapy agents (doxorubicin, bleomycin, disulfiram, cis-platinum, mafenide acetate), those who cannot undergo pressurization/ depressurization because of eustachian-tube dysfunction and confinement anxiety.

Keywords: blepharoplasty hyperbaric oxygen ecchymosis edema wound healing
stromal vascular fraction for treatment of xerostomia

Conditions: Xerostomia Due to Radiotherapy (Disorder)

Summary: prospective, single center, double armed, randomized treatment with observation only (standard of care) control group. subjects receiving study treatment will have 6 months of study follow-up. stromal vascular fraction (svf), an adipose-derived tissue preparation, will be injected into salivary glands to determine safety and efficacy to restore saliva production in head and neck cancer patients with chronic xerostomia resulting from radiation therapy.


Eligibility criteria:
inclusion criteria: * male and female subjects are both eligible * subjects must be 21 years of age or older * history of treated head and neck cancer, no evidence of active cancer at the time of the study * original tumor not located adjacent to the parotid or sub-mandibular glands * diagnosis of radiation-induced xerostomia * study is fully explained * females of child bearing potential agree to use acceptable methods of contraception through 6 month study follow-up. * no current malignancy or history of previous malignancy within the last five years, other than the head and neck cancer, with the exception of adequately treated non-abdominal, non-melanoma cutaneous carcinoma (basal cell or squamous cell carcinoma of the skin) * willing to undergo a minor surgical procedure (small-volume liposuction, totaling approximately 60-120cc) and a single treatment of an injection of approximately 30ml of autologous stromal vascular fraction taking approximately 10 minutes * abdominal area amenable to liposuction of at least 60-120cc of adipose tissue based on investigator(s) examination * willing to be available for all baseline, treatment and follow-up examinations required by protocol * willing to forego participation in any other study throughout the duration of this study unless receiving prior approval by investigator exclusion criteria: * patients taking immunosuppressive therapy in the prior 3 months * autoimmune disorders * patients who are pregnant or currently breast-feeding children * patients participating in a study of an experimental drug or medical device within 60 days of study entry * uncontrolled hypertension * reported unstable cardiovascular disease (e.g., unstable angina, myocardial infarction within past 6 months, cardiac failure or life-threatening arrhythmia, congestive heart failure) or symptomatic postural hypotension within 6 months before screening * hemoglobin a1c \> 8% within 8 weeks prior to study treatment * current use of steroids or immunosuppressant therapies * any other condition, which, in the opinion of the investigator, would contraindicate treatment, affect compliance, interfere with study evaluations, limit study participation, or confound the interpretation of study results * history of sjogren's syndrome or related autoimmune disease. * taking medication for which xerostomia is a known major side effect
a phase ⅰb/ⅱ clinical study of shr-a1811 combined with other therapies in patients with her2 low advanced or metastatic breast cancer.

Conditions: HER2 Low Advanced or Metastatic Breast Cancer

Summary: this study aims to evaluate the safety, tolerability, pk and preliminary anti-tumour activity of shr-a1811 combined with other therapies in patients with her2 low advanced or metastatic breast cancer.


Eligibility criteria:
inclusion criteria: 1. ability to give informed consent, signed and dated irb/ec approved informed consent, willing and able to comply with treatment planning visits, tests and other procedural requirements 2. when signing the informed consent, the age is 18-75 years old (including both ends), female patients who have pathologically documented her2 low breast cancer 3. ecog performance status of 0 or 1 4. patient must have adequate tumor sample for biomarker assessment 5. at least one measurable lesion 6. adequate organ function exclusion criteria: 1. there are untreated or active central nervous system (cns) tumor metastases 2. there was a third space effusion that could not be controlled by drainage (such as a large number of ascites, pleural effusion and pericardial effusion) 3. major surgery within 4 weeks prior to enrollment 4. has multiple primary malignancies within 5 years, excluding cured basal cell carcinoma of skin, cervical carcinoma in situ, papillary thyroid carcinoma, etc 5. has current ild/pneumonitis, or where suspected ild/pneumonitis cannot be ruled out at screening 6. uncontrolled intercurrent illness 7. uncontrolled or significant cardiovascular disease 8. has known human immunodeficiency virus (hiv) infection, or active hepatitis b or c infection. 9. according to nci-ctcae v5.0 classification, those who have not recovered to grade ⅰ toxicity caused by previous anti-tumour treatment
safety and tolerability of 28 days treatment with glycopyrronium bromide (nva237) (100 or 200 µg once a day) in patients with moderate to severe chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: this study assessed the safety/tolerability of 28 days of treatment with nva237 100 µg and 200 µg once a day, compared to placebo in patients with moderate or severe chronic obstructive pulmonary disease (copd).


Eligibility criteria:
inclusion criteria: * male or female adults aged 40 years or older * patients with moderate to severe copd according to the gold guidelines (2006) * patients who have smoking history of at least 10 pack years * patients with a post-bronchodilator forced expiratory volume in one second (fev1) equal or greater than 30% of the predicted normal value and less than 80% of the predicted normal value, and post-bronchodilator fev1/fvc less than 0.7 at visit 2 * written informed consent by the patient prior to initiation of any study-related procedure exclusion criteria: * patients requiring oxygen therapy on a daily basis for chronic hypoxemia, or who have been hospitalized for an exacerbation of their airways disease in the 6 weeks prior to visit 1 or during the screening period (up to visit 3). * patients who have had a respiratory tract infection within 6 weeks prior to visit 1 or during the screening period (up to visit 3). * patients with a history of asthma indicated by (but not limited to): blood eosinophil count \> 400/mm3, onset of symptoms prior to age 40 years. * patients with a history of long qt syndrome or whose qtc measured at visit 1 is prolonged (more than 440 ms for males or more than 460 ms for females). * patients with a history of untoward reactions to sympathomimetic amines or inhaled medication or any component thereof. * patients who, in the judgment of the investigator have a clinically relevant laboratory abnormality or a clinically significant condition such as (but not limited to) unstable ischemic heart disease, left ventricular failure, long term prednisone therapy, history of myocardial infarction, arrhythmia, narrow-angle glaucoma, symptomatic prostatic hyperplasia, bladder-neck obstruction or moderate to severe renal impairment that might compromise patient safety or compliance, interfere with evaluation, or preclude completion of the study. * history of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin. other protocol-defined inclusion/exclusion criteria may apply

Keywords: copd glycopyrronium bromide antimuscarinic
comparing two forms of head immobilization for stereotactic radiotherapy

Conditions: Patients Receiving Fractionated Stereotactic Radiotherapy; for Brain Tumors

Summary: fractionated stereotactic radiotherapy (srt) requires extremely precise and reproducible immobilization of the patient's head. this randomized study compares the efficacy of two commonly used forms of immobilization used for srt.

primary objective: 1) to compare the efficacy of two commonly used, generally accepted forms of immobilization for the treatment of lesions in the head with fractionated stereotactic radiotherapy. specifically, this study will use the exactrac kilovoltage imaging system to assess positioning accuracy for these two systems. outline: two routinely used methods of immobilization, which differ in their approach to reproduce head position from day-to-day are the gill-thomas-cosman (gtc)frame and the brainlab thermoplastic mask. the gtc frame fixates on the patient upper detention and thus us in direct mechanical contact with the cranium. the brainlab mask is a two-part masking system custom-fitted to the front and back of the participant's head. after patients sign an irb-approved informed consent form, eligible participants are either randomized to either the gtc frame or the mask for their course of srt. participants are treated as per standard procedure; however, prior to each treatment, a set of digital kv images (exactrac, brainlabab, germany) is taken. these images are fused with reference digitally constructed radiographs obtained from treatment planning ct to yield lateral, longitudinal, and vertical deviations of isocenter and head rotations about respective axes. the primary endpoint of the study is to compare the two systems with respect to mean and standard deviations (sds) using the distance to isocenter measure.

Eligibility criteria:
inclusion criteria: * patients who are eligible for fractionated stereotactic radiotherapy exclusion criteria: * severe claustrophobia

Keywords: stereotactic radiotherapy
caregiver solutions for dementia patients

Conditions: Alzheimer's Disease; Dementia; Caregivers; Remote Monitoring

Summary: the goal of this clinical trial is to test a mobile application amongst caregiver's supporting patients diagnosed with alzheimer's disease and related dementias (adrd). the main question it aims to answer is: will caregivers supporting patients diagnosed with adrd utilize a mobile application to routinely report symptoms of the patients they care for?


Eligibility criteria:
inclusion criteria: * caregiver of a duke patient with alzheimer's disease or alzheimer's disease-related dementias (adrd), participating in the duke dementia family support program * the ability to speak and understand english * age \> 18 years exclusion criteria: * those unable to speak and understand english * age ≤ 18 years
effects of core stability exercises with and without treadmill training on balance in children with down syndrome

Conditions: Down Syndrome

Summary: to find the effects of core stability exercises with and without treadmill training on balance in children with down syndrome


Eligibility criteria:
inclusion criteria: * able to stand and walk independently * able to understand and follow a verbal command * cutoff score less than 6 or 7 in functional balance in indicated exclusion criteria: * patients have any neurological issue, * instability of atlantoaxial joint * vision and hearing loss * history of fall

Keywords: core stability exercises balance treadmill
peer to peer (p2p): mental health interventions with persons with substance use disorders

Conditions: Standard of Care; P2P Intervention

Summary: this study provides substance use and mental health peer support services to address behavioral health disparities in rural areas. specifically, the project aims to address persistent mental health symptoms, such as anxiety and depression, that become barriers to care for patients working towards long-term recovery from co-occurring mental health and substance use disorders. participants will be assessed and evaluated for opioid use disorder (oud), social determinants of health (sdoh), and infectious diseases by a nurse practitioner and a social worker. a certified peer support specialist (cpss) will provide additional support, connecting patients to sustainable mental health resources and implementing a modified version of the friendship bench intervention, which involves six weekly 45-minute problem-solving therapy sessions with the option to participate in six or more peer support sessions. the cpss will follow the patient for up to 12 weeks.


Eligibility criteria:
inclusion criteria: * diagnosis of oud via diagnostic statistical manual (dsm)-v text revision (tr) * receiving moud through the mobile recovery program for at least 3 months * age 18 or older * moderate to severe depression with or without co-occurring anxiety as determined by phq-9 conducted during the most recent mrp clinical visit exclusion criteria: * severe cognitive, medical, or psychiatric disability that could impair ability to perform study-related activities as determined by the mrp clinician or principal investigator. * unable to read/speak english * unable to read and comprehend the consent materials and other study materials * current suicidal ideation based on the patient health questionnaire-9