Kornimate/medical-research-clean huggingface dataset:
depersonalization disorder: therapeutic effect of neuronavigated repetitive transcranial stimulation

Conditions: Depersonalization Disorder

Summary: the purpose of this study is to assess the therapeutic efficacy of transcranial magnetic stimulation in patients with depersonalization disorder.

depersonalization disorder is characterised by a profound disruption of self-awareness. depersonalization symptoms may occasionally arise (30 to 70% of the population) or may become chronic in depersonalization disorder. its prevalence is around 2.4% in the general population. this disorder is particularly resistant to pharmacological treatments. this study is a randomized, double-blind, placebo-controlled study, and the investigators are testing the therapeutic efficacy of neuronavigated repetitive transcranial magnetic stimulation (tms) of right angular gyrus in patients with depersonalization disorder.

Eligibility criteria:
inclusion criteria: patients: * outpatients aged over 18 years old * suffering from depersonalization disorder according to dsm iv-tr * patients currently on dpd medication must be at the same stable dose(s) at least 2 months and must be continued at the same dose(s) through the duration of the study. * patient provided informed written consent * patient covered by a contributory social security scheme controls: * aged over 18 years old * absence of a personal history of psychiatric disorders * provided informed written consent * covered by a contributory social security scheme exclusion criteria: * patients: * cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease. * intracranial implants (e.g. aneurysms clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed. * history of neurosurgery, * neurosurgical ventriculoperitoneal bypass valves * personal and / or family history of seizures or epilepsy * dental device * pregnant woman * claustrophobic subjects * not cooperating or agitated patients * medications that reduce the seizure threshold, such as clozapine, bupropion, methadone and / or theophylline * alcohol abuse and / or toxic substances in the last 12 months * substance dependence except tobacco controls: * cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease. * intracranial implants (e.g. aneurysms clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed. * neurosurgical ventriculoperitoneal bypass valves * claustrophobic subjects * pregnant woman * not cooperating or agitated patients * dental device

Keywords: depersonalization derealization embodiment emotional numbing transcranial magnetic stimulation angular gyrus temporo-parietal junction
cholesterol metabolism and lipid transfer in diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: the diabetic dyslipidemia is one of the most important risk factor in the development of coronary artery disease. the low density lipoprotein (ldl)-like nanoemulsions is being used to study the clearance of cholesteryl ester and free cholesterol from intravascular in patients with advanced coronary artery disease and it was shown a higher removal of free cholesterol and higher deposit in vases of this patients. the aim of this study is to analyze the plasma kinetics of both forms of cholesterol(free ad esterified) in type 2 diabetes patients without a previous history of cardiovascular disease.

hypercholesterolemia is not typical of type 2 diabetes mellitus dyslipidemia, but alterations in ldl may occur related to atherogenesis.cholesterol exist in two main forms in organism: free cholesterol and the esterified cholesterol. an artificial model to study this two forms of cholesterol is the use of ldl-like nanoemulsion doubly labeled with 14c-cholesteryl esters and 3h- cholesterol. this nanoemulsion is made without protein and when in the intravascular compartment it is able to acquires apolipoproteins from others lipoproteins, such apos a's, c's and e. this model allowed us to use the nanoemulsion particle as a probe to study the lipoproteins receptor binding and the cholesterol esterification process.

Eligibility criteria:
inclusion criteria: * without a previous cardiovascular disease * if arterial hypertension, or in use of antihypertensive drugs- it must be well controled with a systolic blood pressure level \<130mmhg and diastolic \<85mmhg. * total cholesterol \< 6 mmol/l * ldl- cholesterol \<4 mmol/l exclusion criteria: * use of drugs- statins, fibrates, glucocorticoids, thiazolidinediones * nephropathy- the presence of microalbuminuria(ratio of microalbuminuria/creatinin \>30 ug/mg) or serum creatinin above 98umol/l in woman and above 115 umol/l in man * retinopathy * neuropathy presence of chronic disease: heart failure, chronic obstructive pulmonary disease, inflammatory disease and cancer

Keywords: type 2 diabetes mellitus dyslipidemia kinetics
ultrasound in detecting taxane-induced neuropathy in patients with breast cancer

Conditions: Peripheral Neuropathy; Stage 0 Breast Cancer; Stage I Breast Cancer; Stage IA Breast Cancer; Stage IB Breast Cancer; Stage II Breast Cancer; Stage IIA Breast Cancer; Stage IIB Breast Cancer; Stage III Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer; Stage IV Breast Cancer

Summary: this pilot clinical trial studies how well ultrasound works in detecting taxane-induced neuropathy in patients with breast cancer. ultrasound may work better in diagnosing and detecting neuropathy in breast cancer patients treated with the chemotherapy drug called a taxane.

primary objectives: i. to compare tibial motor nerve ultrasound cross-sectional area (csa) between taxane-induced peripheral neuropathy (tipn) patients and historical data among healthy adults. secondary objectives: i. to compare sural sensory nerve ultrasound csa between tipn patients and historical data among healthy adults. ii. to determine if the above changes in nerve csa correlate with ncs changes in the same tipn patients. iii. to determine if the above changes in nerve csa correlate with changes on a self-reported neuropathy scale (quality of life questionnaire - chemotherapy-induced peripheral neuropathy 20 \[qlq-cipn20\]) in the same tipn patients. iv. to determine if the above changes in nerve csa correlate with intraepidermal nerve fiber (ienf) density changes on skin biopsy in the same tipn patients. tertiary objectives: i. to assess activated mast cells in skin biopsies in tipn patients in relation to severity of symptoms and above findings. ii. to assess serum inflammatory markers in tipn patients in relation to severity of symptoms and above findings. outline: patients undergo peripheral nerve ultrasound. patients also undergo skin biopsy. after completion of study, patients are followed up for 30 days.

Eligibility criteria:
inclusion criteria: * breast cancer (any stage) * previously or currently receiving taxane-based chemotherapy * clinical symptoms of peripheral neuropathy noted in medical record and suspected to be secondary to taxane-based therapy * ability and willingness to understand and sign an informed consent exclusion criteria: * self-reported or documented history of pre-existing peripheral neuropathy prior to initiation of taxane chemotherapy * unable to provide history
a phase i clinical study of qlc1101 in patients with advanced solid tumors

Conditions: Non-small Cell Lung Cancer; Colorectal Cancer; Pancreatic Cancer; Solid Tumor

Summary: qlc1101 is a selective reversible inhibitor of kras g12d, with the dosage form of capsules and administration route of oral administration. in the first-in-humans (fih) study, the sponsor will explore the safety, tolerability, pharmacokinetics (pk), and preliminary efficacy of qlc1101 in subjects with advanced solid tumors harboring a kras g12d mutation. the fih study includes dose escalation, pk expansion, and efficacy expansion.


Eligibility criteria:
inclusion criteria: 1. patients with histologically confirmed advanced (metastatic or unresectable) solid tumors harboring a kras g12d mutation. sign the icf. 2. those who fail or are unable to tolerate standard treatment, lack standard treatment, or refuse to receive standard treatment; 3. those who are able to swallow and retain oral medication and must not have any clinically significant gastrointestinal abnormality that may alter absorption; 4. subjects who have at least one measurable lesion documented by computed tomography (ct) and/or magnetic resonance imaging (mri) as confirmed by the investigator per the recist v1.1 criteria. 5. ecog ps score: 0 or 1; 6. expected survival time ≥ 3 months; 7. adequate organ function at screening: exclusion criteria: 1. previously treated with inhibitors against kras g12d mutation; 2. the period of time prior to the first dose of investigational product should be at least 28 days from previous treatment or at least 5 half-lives 3. known immediate or delayed hypersensitivity or idiosyncratic reaction to the ingredients of the preparation used in the trial; 4. presence of other active malignant tumors in addition to primary tumors; 5. presence of serious lung diseases at screening; 6. clinically significant gastrointestinal disorders or other conditions that seriously interfere with drug absorption; 7. severe hereditary or acquired hemorrhagic diathesis or coagulation disorders; 8. complicated with clinically significant cardiovascular and cerebrovascular disorders; 9. history of allogeneic hematopoietic stem cell transplantation or organ transplantation (except corneal transplantation); 10. presence of known mental disorders, epilepsy, dementia, or alcohol and drug abuse that may affect the compliance with study requirements; 11. the investigator determines that participation in the study is not in the best interest of the subject.
effect of pharmacogenomics differences in phase i and ii metabolism of tamoxifen on efficacy and toxicity

Conditions: Breast Cancer; Ductal Carcinoma in Situ

Summary: this study will be an open-label prospective observational trial designed to test associations between polymorphisms of candidate genes and tamoxifen. pre- and post-menopausal women taking tamoxifen as standard therapy or chemopreventive therapy will be included in this study.

this study will be an open-label prospective observational trial designed to test associations between polymorphisms of candidate genes (focusing initially on the ugt2b7 enzyme) and tamoxifen (tam) toxicity. pre- \& post-menopausal women (aged ≥18 years) taking tam (20 mg/day) as standard therapy or chemopreventive therapy will be included in this study. patients will be enrolled after they complete all primary surgery, radiation, and adjuvant chemotherapy. patients will be excluded if they are undergoing other adjuvant endocrine therapies. other reasons for exclusion will include patients who are pregnant or lactating, or are currently on corticosteroids, phenobarbital, or megestrol acetate. the goal will be to recruit a total of 45 eligible patients over a 1 year accrual period. the investigators expect to treat \~50 new patients per year with tam at the standard dose of 20 mg/day.

Eligibility criteria:
inclusion criteria: * patients receiving tamoxifen for adjuvant therapy of breast cancer or ductal carcinoma in situ, or as chemoprevention * age 18 years and above * may be pre- and post-menopausal * females * patients may be at any point in their hormonal treatment, but must have completed any planned surgery, radiation and chemotherapy * must use a reliable form of birth control exclusion criteria: * pregnant * breastfeeding * concurrent use of corticosteroids, megestrol, or phenobarbital * history of allergy to tamoxifen * unwilling to have a yearly gynecological exam

Keywords: breast cancer hot flashes tamoxifen
developing a resiliency intervention to support healthcare workers engaged in the provision of hiv care

Conditions: Stress; Burnout, Professional

Summary: the purpose of this study is to pilot an adapted resiliency-based mind-body intervention (the relaxation response resiliency program; the 3rp) for nurses that care for people with hiv (pwh) in the public sector in south africa (sa). in phase 1 \[nih grant number: r34mh131426; human research ethics committee (hrec) ethics reference number: 220813\], the investigators conducted focus group discussions to solicit feedback on: the role of culture and perceptions of stress; the lived experiences of stress; sources of stress (e.g. occupational, trauma related); how stress impacts job functioning (specifically patient care); current coping strategies; and the intervention modules (content, number of sessions, session duration, program length, mode of delivery (e.g., virtual, in-person, hybrid approaches, use of coaches), etc.). in this phase 2, the investigators will conduct a small proof-of-concept study (n = 8-10), followed by a randomized pilot (n = 60) of nurses that care for pwh in the public sector in south africa (sa) to test the feasibility and acceptability of the adapted intervention.

this study will pilot test an adapted version of an existing stress management and resiliency-enhancing intervention (the relaxation response resiliency program; the 3rp) for nurses that care for pwh in the public sector in sa, to test the feasibility and acceptability of all study procedures. this intervention was adapted and refined from its original format (which consisted of eight, 90-minute weekly group sessions) following focus group discussions (fgds) that explored nurses' preferences and desired modifications to the intervention (phase 1 of this study). this trial will involve a randomized pilot study (n = 60) to test the feasibility and acceptability of the adapted intervention among nurses that care for pwh in the public sector in sa. additionally, the randomized control trial (rct) will collect anonymous clinic client data on demographics, satisfaction with care, client-provider trust, and likelihood of returning to care. we will also collect clinic-level data to understand how to measure client-related outcomes and clinic metrics of hiv care engagement, such as expected patient return rates/measures of retention, percentage of patients with suppressed viral load, frequency of viral load collection, and percentage of patients initiating second line treatment to best understand how to measure these variables in a larger trial testing the efficacy of the intervention.

Eligibility criteria:
inclusion criteria: * providing at least some primary hiv care in a public sector clinic (at the level of professional nurse) for at least one year; * isizulu or english speaking; * able and willing to sign informed consent. exclusion criteria: - participation in cognitive behavioral therapy and/or a mind-body intervention in the past year.

Keywords: nurses hiv resiliency
safety and tolerability study of pci-32765 combined with fludarabine/cyclophosphamide/rituximab (fcr) and bendamustine/rituximab (br) in chronic lymphocytic leukemia (cll)

Conditions: B-cell Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma

Summary: the purpose of this study is to establish the safety of orally administered pci-32765 in combination with fludarabine/cyclophosphamide/rituximab (fcr) and bendamustine/rituximab (br) in patients with chronic lymphocytic leukemia (cll)/small lymphocytic lymphoma(sll).

this is a phase 1b, open-label, parallel-group, nonrandomized, multicenter study of pci 32765 420 mg once daily oral (po) administration in combination with 2 different chemotherapy regimens in subjects with relapsed/refractory chronic lymphocytic leukemia (cll)/small lymphocytic lymphoma (sll).

Eligibility criteria:
inclusion criteria: 1. histologically confirmed cll or sll and satisfying at least 1 of the following criteria for requiring treatment: * progressive splenomegaly and/or lymphadenopathy identified by physical examination or radiographic studies * anemia (\<11 g/dl) or thrombocytopenia (\<100,000/μl) due to bone marrow involvement * presence of unintentional weight loss \> 10% over the preceding 6 months * nci ctcae grade 2 or 3 fatigue * fevers \> 100.5° or night sweats for \> 2 weeks without evidence of infection * progressive lymphocytosis with an increase of \> 50% over a 2 month period or an anticipated doubling time of \< 6 months 2. 1 to 3 prior treatment regimens for cll/sll 3. ecog performance status of ≤ 1 4. ≥ 18 years of age 5. willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty 6. ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local subject privacy regulations) exclusion criteria: 1. any chemotherapy, therapeutic antineoplastic antibodies (not including radio- or toxin immunoconjugates), radiation therapy, or experimental antineoplastic therapy within 4 weeks of first dose of study drug 2. radio- or toxin-conjugated antibody therapy within 10 weeks of first dose of study drug 3. concomitant use of medicines known to cause qt prolongation or torsades de pointes 4. transformed lymphoma or richter's transformation any life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of pci-32765 po, or put the study outcomes at undue risk 5. any of the following laboratory abnormalities: oabsolute neutrophil count (anc) \ 2.0 x uln or creatinine clearance \< 40 ml/min

Keywords: lymphoma, b-cell leukemia, lymphoid leukemia, b-cell bruton's tyrosine kinase
a trial to evaluate the combination efficacy of artificial dermis and growth factor in chronic wounds ulcer

Conditions: Chronic Wound

Summary: double layer artificial dermis repair material has been widely used in scar plastic, burn, trauma, chronic wounds and other aspects of wound repair and reconstruction. in the course of clinical application, we found that for chronic wounds, the combination of artificial dermis and growth factor can shorten the wound healing cycle, and have a positive impact on the economy and psychology of patients. in order to verify this effect, we plan to carry out this study to evaluate whether double-layer artificial dermis repair material combined with growth factor treatment can improve wound closure rate and shorten closure cycle compared with single artificial dermis for chronic wound.


Eligibility criteria:
inclusion criteria: 1. patients diagnosed as chronic wounds ulcer; 2. the affected limb has sufficient blood perfusion. the ankle brachial index was 0.65-1.3, or the partial pressure of oxygen was more than 40 mmhg, or doppler ultrasound showed enough blood flow. 3. after debridement, the distance between the wound and the edge of other ulcers was \>2cm. 4. after debridement, the area of exposed bone or tendon was \>4cm2. 5. the wound was completely debridement without obvious necrosis, infection control or osteomyelitis control. 6. the duration of ulcer wound was at least 30 days. 7. sign the informed consent voluntarily. exclusion criteria: 1. poor control of diabetes (fasting blood glucose ≥ 8.0mmol/l, hba1c ≥ 12%); 2. the researchers think that there are factors affecting wound healing, such as the use of corticosteroids, immunosuppressants and other drugs, chemotherapy or radiotherapy within one year. 3. to receive or plan to receive drugs or treatment, the researchers believe that these drugs or treatment will interfere with or affect the speed and quality of wound healing; 4. unstable charcot's foot or charcot's joint disease with bone protrusion; 5. patients with severe lymphedema, coagulation disorders, autoimmune diseases, cardiovascular and cerebrovascular diseases, and severe hepatopulmonary and renal diseases; 6. those who have received hyperbaric oxygen treatment within 5 days before enrollment, or who have received or plan to receive growth factor, tissue-engineered skin or other skin substitutes treatment within 30 days; 7. those who have participated in or are participating in other clinical studies within 30 days before screening; 8. pregnant, or lactating women; 9. poor general condition or other conditions not suitable for the use of double-layer artificial leather repair materials; 10. be allergic to collagen or chondroitin sulfate; 11. other cases that researchers think are not suitable for the participation.
combined implementation of dural puncture epidural and programmed intermittent epidural bolus for labor analgesia

Conditions: Labor Pain; Labor Analgesia

Summary: this study intends to carry out a prospective, randomized double-blind study to evaluate the safety and efficacy of the combined implementation of dural puncture epidural (dpe) technique and programmed intermittent epidural bolus (pieb) for labor analgesia.

epidural (epl) technique is the standard technique for labor analgesia, but can be associated with slow onset and inadequate sacral spread, unilateral or patchy sensory blockade, motor impairment. the combined spinal epidural (cse) technique can provide rapid onset of analgesia, but is associated with greater side effects, including pruritus, fetal bradycardia and delayed testing of epidural catheters. dural puncture epidural (dpe) technique is a modification of cse technique. a spinal needle is introduced through the epidural needle to create a single dural puncture , after intrathecal space was identified by the free flow of cerebrospinal fluid (csf) , the needle was removed without direct medication administration into the subarachnoid space. privous studies have demonstrated that the dpe technique can improve block quality over the epl technique with fewer maternal and fetal side effects than the cse technique for parturients requesting labor analgesia. besides the neuraxial techniques, maintenance regimens is another factor that affect the analgesic effect. programmed intermittent epidural bolus (pieb) provides greater spread of local anesthetic solution within the epidural space and therefore superior quality of analgesia compared with continuous epidural infusion (cei). we designed this prospective randomized, double-blind study to evaluate the safety and efficacy of the combined implementation of dpe technique and pieb for labor analgesia.

Eligibility criteria:
inclusion criteria: 1. women requeste labor analgesia 2. asa i or ii 3. at 37-42 weeks' gestation 4. nulliparous 5. singleton pregnancy, vertex presentation 6. visual numerical rating scale (vnrs) at requesting analgesia \> 5 (nrps 0-10) 7. cervical dilatation \< 5 cm exclusion criteria: 1. patient refusal to participate in the study 2. age \ 40 years 3. body mass index(bmi)\>50 (kg/m2) 4. clinically significant diseases of pregnancy (i.e.,gestational hypertension, preeclampsia, gestational placenta previa, placental abruption diabetes) 5. contraindications to neuraxial analgesia 6. drug abuse 7. conditions associated with an increased risk of a cesarean delivery (i.e., history of uterine anomaly or surgery, morbid obesity) and known anomalies

Keywords: labor analgesia dural puncture epidural (dpe) standard epidural (epl) continuous epidural infusion (cei) programmed intermittent epidural bolus (pieb)