Kornimate/medical-research-clean huggingface dataset:
frontosubthalamic networks in parkinson's disease.

Conditions: Parkinson Disease; Impulse Control Disorder

Summary: the goal of this experimental study with is to understand the underlying mechanisms behind the increase in impulsivity seen in some patients that undergo deep brain stimulation of the subthalamic nucleus for parkinson's disease. the main questions it aims to answer are: what are the distributed network effects of deep brain stimulation to the subthalamic nucleus? how does this correlate with increased impulsivity? can alternative stimulation settings be used to minimize these? participants will complete decision-making tasks whilst their deep brain stimulation devices are turned on and off with simultaneous magnetoencephalography recordings (a type of non-invasive brain scan that measures brain activity in real-time)


Eligibility criteria:
inclusion criteria: * participant is willing and able to give informed consent for participation in the study. * male or female, aged 18 years or above. * diagnosed with parkinson's disease who have required implanted stn electrodes for dbs in addition to their dopamine replacement therapy. * diagnosed with or without (control group) impulse control disorders since the diagnosis of parkinson's disease. * participant willing and able to sit in the meg scanner and follow instructions. * participant willing and able to delay their morning dose of dopamine replacement therapy for up to four hours (180 minutes experimental time + journey time). exclusion criteria: * patients with extreme language barrier that cannot understand the purpose or instructions of the study despite the use of an interpreter. * other implanted medical devices that may cause artefacts during meg recordings. * participants with a history of co-morbid neurological disorders. * participant enrolled onto another clinical trial related to a neurological disorder (including parkinson's disease) that may interfere with the results of this study. * participants who are unable to sit still in a meg scanner for the duration of this experiment e.g. patients with chronic pain or osteoarthritis. this will be assessed with their primary clinician

Keywords: deep brain stimulation
low energy diet and familial partial lipodystrophy

Conditions: Lipodystrophy; Diabetes; Diet Modification

Summary: to evaluate the therapeutic efficacy and metabolic impact of a low energy diet (led) in people with familial partial lipodystrophy and diabetes. participants will be provided with a led (total diet replacement) for 12 weeks, before the introduction of a stepped food transition. metabolic effects will continue to be assessed for 1 year. in order to better understand why this intervention changes insulin sensitivity, we will also collect adipose and muscle tissue samples at baseline and 12 weeks into the intervention in participants willing to have these procedures performed. these samples will be used for histological, metabolite, gene expression and protein expression analyses.


Eligibility criteria:
inclusion criteria: * familial partial lipodystrophy * age \>= 18 yrs * t2dm * willingness to check daily blood sugars * hba1c between 53mmol(7%)- 108 mmol(12%) * weight stable for 3 months * capacity to consent exclusion criteria: * pregnancy * untreated thyroid dysfunction (patients who have been euthyroid on medication for at least 3 months can be included) * use of medication adversely that affects diabetes control (e.g. steroids/ immunosuppressants/ certain antipsychotics) * incapacity to give informed consent * history of an eating disorder/ purging behaviour * previous gastric bypass/ banding * use of leptin therapy * untreated retinopathy

Keywords: familial partial lipodystrophy fpld diet total diet replacement diabetes
a long-term study of npc-12g gel in neurofibromatosis type i

Conditions: Neurofibromatosis

Summary: the purpose of this tria is to evaluate the safety and efficacy of long-term treatment with npc-12g gel to patients with neurofibromatosis type i.

a phase 3, open-label, uncontrolled, multicenter study to evaluate the safety and efficacy of long-term treatment with npc-12g gel for patients with neurofibromatosis type i. patients who meet all entry criteria for this trial apply npc-12g gel twice a day for 52 weeks or more. approximately 100 eligible patients will be enrolled.

Eligibility criteria:
inclusion criteria: 1. patients diagnosed as neurofibromatosis type 1 based on the clinical diagnostic criteria in guideline of japanese dermatological association 2. patients participated in a phase ii/iii investigator-initiated clinical trial for neurofibromatosis type i (osd-001-004) who wish to continue treatment of the investigational drug 3. at the time of enrollment, patients who are able to choose ten evaluable target lesions for efficacy (at least 5).. 4. patients who have evaluable skin neurofibromas at baseline. 5. males and females who are 3 years old or elder at the time of informed consent. 6. patients who (or whose guardian) give a written informed consent in understanding and willingness after having received enough explanation regarding the study participation. 7. patients whose use or continued use of the investigational drug is judged to be reasonable by the principal investigator or sub-investigator. exclusion criteria: 1. patients who occurred serious adverse effects, who discontinued the sudy due to adverse effects, or who discontinued the trial due to withdrew of their consent in the phase ii/iii investigator-initiated study of neurofibromatosis type i (osd-001-004) 2. patients with abnormal findings (e.g., pneumonia) in the results of chest x-ray at the time of screening 3. patients with creatinine clearance of less than 50 ml/min 4. patients with poorly controlled dyslipidemia (serum triglycerides \>500 mg/dl or ldl cholesterol \>190 mg/dl even with treatment) 5. patients who have complications such as infection, cardiac, hepatic, pulmonary, renal, or hematological diseases and malignant tumors that are considered unsuitable for participation in this trial. 6. patients with alcohol sensitivity or allergy to an ingredient of the study drug (sirolimus) 7. female patients who are pregnant, may be pregnant, or are lactating 8. patients (including male patients with a fertile partner) who cannot consent to use adequate contraception from the date of consent to 12 weeks after the end of treatment 9. patients who participated in any other clinical trial or clinical study, other than the osd-001-004 study, and have taken an investigational or investigational drug within 6 months prior to the date of the consent 10. patients who are participating in an observational study during this trial 11. patients who are considered by the investigator as unsuitable for participation in this trial
scandinavian miller collar study

Conditions: Critical Limb Ischemia

Summary: randomized study to evaluate the effect of adding a vein collar at the distal anastomosis to ptfe-grafts used for bypass to below knee arteries in patients with critical limb ischemia with respect to primary patency, secondary patency, and limb salvage


Eligibility criteria:
inclusion criteria: * critical limb ischemia * need for bypass surgery exclusion criteria: * can not participate in follow-up * has suitable saphenous vein

Keywords: graft patency limb salvage
homeopathic treatment of chronic pelvic pain in women with endometriosis

Conditions: Endometriosis; Pelvic Pain

Summary: endometriosis is a chronic inflammatory disease that causes pelvic pain difficult to treat. in view of this, many patients seek assistance in complementary and alternative medicine, including homeopathic treatment. the absence of evidence in the literature raises controversy about the effectiveness of homeopathic treatment in endometriosis. the aim of this randomized trial is to evaluate the effectiveness of dynamized estrogen compared to placebo in the treatment of chronic pelvic pain of endometriosis.

this is a randomized, double-blind and placebo controlled trial using individualised homeopathic medicine (dynamized estrogen) to treat chronic pelvic pain of endometriosis. patients with endometriosis, chronic pelvic pain and a set of signs and symptoms similar to those of the estrogen adverse events will be recruited in the sector of endometriosis of the clinical division of gynaecological of the hospital das clínicas of the faculty of medicine of the university of sao paulo. the selection process was carried out through the analysis of medical charts and self-completing of structured questionnaires. satisfied the inclusion criteria, fifty patients were randomly and distributed to receive dynamized estrogen or placebo. the primary clinical outcome is the severity of the chronic pelvic pain. statistical analysis will be by intention-to-treat and per protocol comparing homeopathic drug with placebo after 24 weeks of intervention.

Eligibility criteria:
inclusion criteria: primary inclusion criteria: * aged between 18 and 45; * diagnosis of endometriosis (endometrial ectopia) confirmed by imaging test (mri or tvus) or laparoscopy (biopsy); * chronic pelvic pain refractory to conventional hormone treatments and with intensity ≥ 5 on the visual analog pain scale (vas-pain: 0-10 points); secondary inclusion criteria: * symptomatic individualization of patients according to adverse events of estrogen (minimum syndrome of maximum value). exclusion criteria: * absence of clinical and laboratory diagnosis of menopause or * premature ovarian failure

Keywords: endometriosis pelvic pain homeopathy rct
echocardiography examination of the cardiac effects of different regional anesthesia methods

Conditions: Femur Fracture; Spinal Anesthesia; Lumbar Plexus Block

Summary: nerve blocks applied with neuraxial anesthesia and ultrasonography are used for many operations today. neuraxial blocks cause varying degrees of decrease in the blood pressure level of the patients. peripheral blocks may be preferred to avoid the cardiac effects of the neuraxial anesthesia method.

the hypothesis of this study was that spinal anesthesia applied in intertrochanteric femoral fracture operations caused hypotension by lowering the cardiac ejection fraction. in our study, the investigators aimed to find out the effect of different regional anesthesia methods on the cardiac function of the patients by echocardiography.

Eligibility criteria:
inclusion criteria: * 60-100 years old * american society of anesthesiologist score i-iv exclusion criteria: * local anesthetic allergy * bleeding disorder * mental disorder * allergy to drugs used * body mass index above 30
a global registry on second generation and long-acting integrase inhibitor failures

Conditions: HIV; Therapy Failure

Summary: integrase strand transfer inhibitors (insti) inhibit hiv replication by preventing the integration of viral hiv dna into the host's genome. instis are used as part of combination antiretroviral therapy (cart) regimens for both treatment-naive and treatment experienced patients. in clinical practice, virological failure to second generation instis is rare and often without selection of known resistance mutations. considering the use of instis in first line regimens in high income countries and the increasing roll-out in lower and middle income countries, a better understanding of relevant resistance development and clinical failure is urgently needed. the rosetta registry aims at systematically collecting otherwise scattered information on individual cases failing second generation integrase inhibitors, with the goal to inform policy and future use of instis in the treatment of people living with hiv. attending physicians of individuals who are experiencing virological failure on a second generation integrase inhibitor-containing regimen are invited to contribute data to the registry.

the rosetta study collects clinical data and hiv sequences from individuals experiencing failure of art containing second generation instis from americas, africa and europe. if resistance testing is not available, the rosetta team can perform genotypic resistance testing of rt, protease, integrase and 3'-ppt. research objectives: to set up a database with data of individuals who have experienced virological failure on a regimen containing a second generation insti to determine the prevalence of resistance mutations in integrase and 3'-ppt in the dataset to identify possible new resistance mutations outside integrase and 3'-ppt. providing additional funding is retrieved. the study design will be a multicenter observational cohort study. patients will be included from hiv care centers in europe, america and africa, if they fullfill the inclusion criteria.

Eligibility criteria:
inclusion criteria: * confirmed hiv-1 infection * using cart (any regimen) for at least the last 6 months * experiencing virological failure\* on a second generation insti-containing regimen (including monotherapy and dual-therapy regimens) * data on current regimen and previous insti exposure available (start/stop dates and dosing mandatory) * integrase genotypic data available (performed locally) or a plasma/dbs (or csf if available) sample(s) drawn at time of failure available to perform genotypic testing centrally \* virological failure is defined as at least 2 consecutive viral loads (vl) above 50 copies/ml in plasma or 1 vl above 200 copies/ml in plasma. we will also include patients who have a vl of \>50 copies/ml in csf, independent of the vl in plasma. exclusion criteria: * submitted fasta file not passing quality control and unavailability of a stored sample to repeat sequence analysis * missing mandatory data * documented treatment interruption for at least 2 weeks prior to viral load testing.

Keywords: integrase inhibitors hiv drug resistance subtype
dual tasking and upper extremity disability in adolescent idiopathic scoliosis

Conditions: Scoliosis Idiopathic

Summary: the goal of this observational study is to evaluate the dual task and upper extremity disability in individuals with adolescent idiopathic scoliosis compared to healthy controls and to examine their relationship with clinical and radiological parameters in adolescent idiopathic scoliosis (ais). the main questions it aims to answer are: 1. to compare dual task and upper extremity disability in individuals with ais and healthy sex and age-matched healthy controls. 2. to analyze the relationship of dual-task and upper extremity disability in individuals with ais with clinical and radiological parameters all participants' dual-task performance will be evaluated and they will answer the upper extremity disability survey. besides, the study groups will be examined thoroughly and radiological parameters will be calculated to identify the clinical and radiological parameters that affect dual-task performance and upper extremity disability.

adolescent idiopathic scoliosis (ais) is a three-dimensional deformity and sagittal plane changes are accompanied by coronal plane changes. as a result of spinal deformity, morphological changes occur in the trunk and rib cage, and the relationships between body parts are affected. considering the anatomical proximity between the scapula and the rib cage, alteration of the shoulder and upper extremity functions as a consequence of the change in proximal orientation is expected. on the other hand, maintaining postural control depends on the dynamic relationship between sensory information and motor output. dual tasking is an experience-based neurophysiological process that requires a person to perform two tasks simultaneously. when a person has problems with the neurophysiological process, the performance of one or both functions is negatively affected. this observational study aims to evaluate the dual task and upper extremity disability in individuals with adolescent idiopathic scoliosis compared to healthy controls and to examine their relationship with clinical and radiological parameters in ais. all participants' dual-task performance will be evaluated and they will answer the upper extremity disability survey. besides, the study groups will be examined thoroughly and radiological parameters will be calculated to identify the clinical and radiological parameters that affect dual-task performance and upper extremity disability.

Eligibility criteria:
inclusion criteria: * patients diagnosed with adolescent idiopathic scoliosis exclusion criteria: * patients with complaints of neck, back, and shoulder pain * having a known neurological or systemic disease * having cognitive dysfunction that cannot cooperate with evaluations * having undergone musculoskeletal surgery or injury * extremity length difference of more than 1 cm * regular repetitive overhead shoulder movements related to professional or sports activities * bmi \>30 kg/m2
first-in-human positron emission tomography study using the 18f-αvβ6-binding-peptide

Conditions: Breast Carcinoma; Colorectal Carcinoma; Lung Carcinoma; Metastatic Malignant Neoplasm in the Breast; Metastatic Malignant Neoplasm in the Colon; Metastatic Malignant Neoplasm in the Lung; Metastatic Malignant Neoplasm in the Rectum; Pancreatic Carcinoma

Summary: this clinical trial studies the side effects of 18f-alphavbeta6-binding-peptide and how well it works in imaging patients with primary or cancer that has spread to the breast, colorectal, lung, or pancreatic. radiotracers, such as 18f-alphavbeta6-binding-peptide, may improve the ability to locate cancer in the body.

primary objectives: i. to determine the safety, biodistribution and dosimetric properties of 18f-alphavbeta6-binding peptide (bp) in normal tissues and malignancies in cancer patients and correlate concordance with alphavbeta6 expression. outline: patients receive 18f-alphavbeta6-bp intravenously (iv) and then undergo positron emission tomography (pet) scans over 30 minutes each at 30, 60, 120, and 180 minutes post-injection. after completion of study, patients are followed up for up to 6 months.

Eligibility criteria:
inclusion criteria: * diagnosed with primary or metastatic cancer in one or more of the following locations: breast, colorectal, lung, pancreas * eastern cooperative oncology group (ecog) performance score of 0-1 * will sign the institutional review board (irb)-approved consent form * able to remain motionless for up to 30-60 minutes per scan exclusion criteria: * creatinine \> 2 x upper limit of normal * aspartate aminotransferase (ast)/alanine aminotransferase (alt) \> 2 x upper limit of normal * life expectancy \< 3 months (mo) * women who are pregnant or breast-feeding * patients who cannot undergo pet/compute tomography (ct) scanning * lack of availability for follow-up assessments * participation in another clinical trial involving an investigational agent within 4 weeks of enrollment
spinal cord injury model systems (scims) - education module

Conditions: Spinal Cord Injuries; Obesity; Cardiometabolic Syndrome

Summary: the purpose of this study is to find out if receiving education regarding increased risks of cardiometabolic disease helps subjects understand these risks and how these risks participants' health.


Eligibility criteria:
inclusion criteria: 1. men and women with sci/d aged 18-70 years. 2. neurologically complete and incomplete american spinal injury association (asia) impairment scale (ais) a-d spinal cord levels c5 and below. 3. enrolled no later than 4 months following discharge from initial rehabilitation from sci. exclusion criteria: 1. pregnancy determined by urine testing in sexually active females. 2. cognitive impairment that compromises the legitimacy of consent. 3. grade 3-4 pressure injury at the time of study entry. 4. prisoners
comparative study of 5 days of m02-472 clarithromycin extended-release tablets to 7 days of clarithromycin immediate-release tablets for the treatment of exacerbation of chronic bronchitis

Conditions: Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB).

Summary: to compare the efficacy of a 5-day course of clarithromycin extended-release tablets (2 x 500 mg qd) with that of a 7-day course of clarithromycin immediate-release tablets (1 x 500 mg bid) in the treatment of acute bacterial exacerbation of chronic bronchitis.


Eligibility criteria:
inclusion criteria: * ambulatory subject who does not require intravenous antibiotic therapy. * subject who has a medical history of chronic bronchitis. * a history of regular medication use (\>=3 consecutive months within the past 2 years) to treat pulmonary disease. * subject must have evidence of pulmonary function test abnormalities. * the onset of signs and symptoms of the current exacerbation must occur within 14 days before evaluation 1. exclusion criteria: * medical history of hypersensitivity, allergic or adverse reactions to clarithromycin, erythromycin, or any of the macrolide antibiotics. * a female who is pregnant or is lactating. * subject who has suspected or known (positive chest radiograph) pneumonia. * subject who has evidence of significant bronchiectasis (by ct) or atelectasis, active tuberculosis or other mycobacterial infection, bullous emphysema, pulmonary embolism, lung abscess, tumor (primary or metastatic) involving the lung, pleural effusion, or cystic fibrosis that could confound the assessment of signs and symptoms of abecb. * subject who requires parenteral antibiotic therapy. * subject who requires hospitalization for treatment of current episode of abecb. * subject who has any other infection or condition, which necessitates use of a concomitant systemic antibiotic. * subject who has any underlying condition/disease, which would be likely to interfere with the completion of the course or absorption of study drug therapy or follow-up. * subject who has a severe or complicated lower respiratory tract infection or a severely compromised respiratory status (i.e., oxygen dependent, requiring hospitalization). * known significant renal or hepatic impairment.
treatment of postmastectomy pain syndrome with fat grafting

Conditions: Post-Mastectomy Chronic Pain Syndrome (Disorder)

Summary: this study evaluates the possible beneficial effect of fat grafting for post mastectomy pain syndrome. half of patients will receive fat grafting and the other half of patients will receive sham.

several studies have suggested that fat grafting can alleviate pain in post mastectomy pain syndrome. these studies however have either been in the form of case series or unblinded studies with great risk of bias. it is believed that fat grafting with its content of adipose-derived stem cells can modulate the scar tissue upon grafting and hereby decrease pain. in this study patients will be randomized to either fat grafting or a sham procedure where they undergo the same liposuction but no fat grafting, only injection of saline instead of fat.

Eligibility criteria:
inclusion criteria: * treated for breast cancer * pain in the breast cancer treated area on the breast or axilla. * pain present at least 4 days a week with an intensity above 3 on vas. * duration longer than 3 months * recurrence free for minimum 6 months * understand the nature of the study and can give informed consent exclusion criteria: * psychiatric condition that can affect participation. * recurrence of breast cancer at any time. * other indication for fat grafting other than pain treatment. * breast reconstruction with flap