Kornimate/medical-research-clean huggingface dataset:
sdf1 plasmid treatment for patients with peripheral artery disease

Conditions: Peripheral Arterial Disease

Summary: to investigate the efficacy of the administration of jvs-100 delivered via direct intramuscular injections on a 3 month and 6 month composite endpoint of wound progression, healing and limb loss in patients with severe peripheral arterial disease with non-healing chronic wounds who undergo an open bypass grafting or endovascular procedure for treatment of infrapopliteal disease and are dosed within 12 days and 3 months following the procedure.


Eligibility criteria:
major inclusion criteria: * age ≥18 * currently receiving standard of care wound treatment (\>2 weeks) for chronic wounds or gangrene including as indicated: debridement, pressure offloading, infection control, and/or maintenance of a moist wound environment. * diagnosis of advanced pad with tissue loss (ulceration and/or dry gangrene) on the foot of the index leg with an ulcer size of at least 0.5 cm2 and \<25 cm2. index wounds on the heel must be \<10 cm2 that cannot be probed to bone, have exposed bone or osteomyelitis. * post revascularization intervention inclusion criteria include an attempt at open bypass grafting or endovascular intervention of a popliteal/infrapopliteal lesion(s) on the same leg that has tissue loss without significant improvement in tbi post intervention. the following will be accepted as demonstrating a lack of post intervention toe brachial index (tbi) improvement: * tbi ≤ 0.51or; * toe pressure ≤50 mmhg with flat or dampened wave forms or; * skin perfusion pressure ≤40 mmhg at mid foot level or; * tcpo2 ≤40 mmhg * subjects willing to forgo treatment with hyperbaric oxygen, nerve stimulation or sympathectomy for the treatment of advanced pad from time of consent to 6 months following the initial injection of study drug major exclusion criteria: * previous major amputation of the leg to be treated or planned major amputation or transmetatarsal amputation within the first month following enrollment. * only a short segment superficial femoral artery lesion - consistent with inter-society consensus for the management of peripheral arterial disease (tasc ii) a or b category, and no infrapopliteal disease * staged or planned intervention in the index leg within 30 days after the index procedure * acute limb-threatening ischemia, trauma, known non-atherosclerotic vascular disease * non-salvageable limb defined as major tissue loss and an unsalvageable foot; * wounds that have decreased in size by \>50% between the screening visit and day 0. * if patient has active infection of the index limb that is being treated, and, in the opinion of treating physician, will not lead to an amputation within the next 3 months, the patient can be enrolled. * inability to safely perform a revascularization procedure due to uncontrolled diabetes or other medical condition. * presence of any other condition that, in the opinion of the investigator, might compromise any aspect of the trial
intramuscular hydroxyprogesterone caproate and placenta previa

Conditions: Preterm Labor

Summary: antepartum hemorrhage is defined as bleeding from or within the female genital tract, occurring from 24+0 weeks of pregnancy and till delivery of the fetus. antepartum hemorrhage occurs in 3-5% of pregnancies and is an important cause of perinatal and maternal morbidity and mortality worldwide. placenta previa is a placenta inserted wholly or in part into the lower segment of the uterus. it is classified by ultrasound to placenta previa major degree when the lower edge of the placenta lies within 2 cm from the internal cervical os and placenta previa minor degree if the lower edge of the placenta at lower uterine segment but more than 2 cm from internal os. placenta previa is responsible for 0.03% of maternal mortality and 8.1% of perinatal mortality of 8.1% in the developed world and much more in developing countries. many studies in literature proved the positive correlation between the placenta previa and preterm uterine contractility and also reported that large proportion of women who have placenta previa associated with vaginal bleeding will have subclinical uterine contractions before the onset of evident vaginal bleeding. there are many tocolytic agents may have a role in conservative management of placenta previa such as magnesium sulfate and β-sympathomimetics .progesterone is essential for continuation of pregnancy and helps in maintenance of pregnancy . delaying delivery may reduce the fetal morbidity by helping maturity of vital organs. in 2003 meis et al. in a large randomized placebo-controlled trial found a significant reduction in recurrent preterm birth before 37 weeks for women who received 17αhp-c versus a control group receiving placebo (36.3% versus 54.9%).


Eligibility criteria:
inclusion criteria: 1. estimated gestational age is ranging between 24 weeks and 26 week's gestation 2. singleton pregnancy. 3. placenta previa; either major or minor degrees. 4. placenta previa with minimal vaginal bleeding or haven't any vaginal bleeding. 5. for outpatient follow ups, women should be living in a nearby area to make follow-up and early transportation are reasonably possible. 6. accepting to participate in the study. exclusion criteria: 1. definite rupture of membranes. 2. established preterm labor. 3. severe attack of bleeding requiring an immediate intervention. 4. fetal heart rates instability or non reassuring 5. intrauterine fetal death or major fetal anomalies. 6. if associated with abruptio placentae 7. patients with known bleeding disorders or on anticoagulant therapy 8. patents with severe medical disorders as preeclamptic toxemia, diabetes mellitus, hepato-renal impediment ...etc 9. the presence of reported side effects in the mother from 17α hydroxy progesterone caproate like hypersensitivity reactions, cough, dyspnea, and diabetes.
cost-utility study of a group of compensatory cognitive remediation in schizophrenia

Conditions: Schizophrenia

Summary: significant cognitive impairment (executive functions, memory, attention) is common in schizophrenia affecting up to 80% of patients. but pharmacological treatments (typical and atypical antipsychotic) do not have impact on cognitive functioning. for over 20 years, alternative non-pharmacological therapeutics have been developed in schizophrenia. these techniques called cognitive remediation specifically target cognitive deficits. the first cognitive remediation available for patients was designed to stimulate new learning, or relearning, of cognitive tasks, and thus to improve certain deficient domains. these procedures were efficient in improving cognition as measured by neurocognitive tests but their impact on functioning and daily life was weak. in a second time, compensatory remediation has been developed. compensatory approaches seek to make improvements in the patient's functioning by avoiding areas of impairment and recruiting other intact cognitive domains or by creating a supportive external environment. in recent meta-analysis compensatory remediation has larger effect-size than classical cognitive remediation, with an impact on patients psychosocial functioning. recently, dr e. twamley (university of california) developed and tested a group-based, manualized, compensatory cognitive training intervention. compensatory cognitive training (cct) is a low-tech, brief intervention and is easily transposable in community care. our team translated this method into french. the investigators planned a cost -utility study between cct and treatment as usual in schizophrenia patients with less than 10 years of evolution.

this study will take place over 3 years with a recruitment period of 18 months. after verification of the eligibility criteria and signature of the consent, the patients will be divided into 2 groups by randomization: the intervention group and the control group. the duration of participation of the subjects will be 12 months. assessments are available in 4 steps (v1 at inclusion, v2 at 3 months, v3 at 6 months and v4 at 12 months). these visits include an assessment of the functioning of patients, symptomatology, quality of life, treatment and care received at all visits, occupational activity and cognitive assessment and social knowledge at v1 and v4.

Eligibility criteria:
inclusion criteria: * diagnostic with schizophrénie * less than 10 years of the evolution of the disease exclusion criteria: * history of severe cranial trauma and / or neurological pathology with cognitive impairment * ongoing participation in another study for treatment of negative or cognitive symptoms * ongoing participation in a study on management in psychotherapy for cognitive disorders and negative symptoms

Keywords: cognitive remediation, cost-effectiveness analysis
insulin glargine during and after the period of fasting in ramadan

Conditions: Diabetes Mellitus, Type 2

Summary: primary objectives : * to compare the number of hypoglycaemic events (severe, symptomatic, asymptomatic, nocturnal) in patients with type 2 diabetes treated with insulin glargine (lantus®) and glimepiride (amaryl®), before, during and after the period of fasting in ramadan. secondary objectives : * to assess glycaemic control before, during and after ramadan in terms of hba1c, fbg, and 8-point blood glucose profile (fbg and 8-point blood glucose profile will be collected with a blood glucose monitor through a monthly patient diary). * to assess the relationship between hypoglycaemia events during ramadan and blood glucose control prior and during ramadan. * to assess patient satisfaction * to document adverse events (all serious adverse events, non serious adverse events) throughout the study (all events will be collected through the monthly patient diary).


Eligibility criteria:
the following information on clinical trials is provided for information purposes only to allow patients and physicians to have an initial discussion about the trial. this information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional. main criteria are listed hereafter: inclusion criteria: * patients with type 2 diabetes mellitus (but without history of ketoacidosis); * bmi \> 25 and \< 40 kg/m2; * willingness to participate and to fast during ramadan; * patients should be either: * insulin naïve patients * patients already receiving insulin exclusion criteria: * pregnancy (as determined by pregnancy blood test at inclusion visit) * breast- feeding * women of childbearing potential who do not have adequate contraceptive protection * need for treatment during the study period with medications that may interfere with the study protocol * treatment with any investigational drug (only if in trial) in the last 3 months before entry into the study * history of drug or alcohol abuse * severe and unbalanced diabetic retinopathy * clinically relevant cardiovascular, gastrointestinal, hepatic, renal, neurological, endocrine, hematological or other major systemic diseases that may interfere with the study protocol or complicate the interpretation of study results * night shift workers
hepb-cpg series for healthcare workers who are hepatitis b vaccine nonresponders

Conditions: Healthcare Worker, Hepatitis B Vaccine, Nonresponder

Summary: this study is being done to determine if healthcare workers who have previously failed to respond to hepatitis b vaccine series will respond to a hepatitis b with cpg adjuvant (hepb-cpg) (heplisav-b)

study intervention each individual who has completed at least 5 doses hepb vaccine with aluminum adjuvant series but is anti-hbs negative will be contacted by ehs staff and invited to receive the hepb-cpg two dose series on a 0 and 1 month schedule. antibody to the surface antigen will be measured after the first dose during the visit for the administration of the second dose. one month after completion of the series, each immunized individual will have another anti-hbs measured. total number of subjects up to 130 individuals will be recruited and enrolled. study population healthcare workers who have received at least 5 doses of hepatitis b vaccine with aluminum adjuvant and have antihbs \< 10miu/ml.

Eligibility criteria:
inclusion criteria: * willing to provide informed consent * willing to comply with all study procedures and be available for the duration of the study * healthcare workers who have received at least 5 doses of hepatitis b vaccine with aluminum adjuvant and have antihbs \< 10miu/ml * females of childbearing potential will be asked about the possibility of pregnancy as is the standard of care for immunization services. if a female indicates that she may be pregnant, study participation will be postponed until pregnancy is completed or the female reports that she is not pregnant. exclusion criteria: * women who are pregnant or planning on becoming pregnant during the study * allergy to the vaccine or a component of the vaccine * not suitable for study participation due to other reasons, such as inability or unwillingness to comply with the study procedures, at the discretion of the investigators
correlation analysis of the effects of management pressure goals and control volume goals in patients in spinal surgery

Conditions: Hypotension,Controlled

Summary: the investigators study 160 patients undergoing spinal surgery.participants will be randomly divided into study group and control group.the study group will receive controlled hypotension by nitroglycerin and be divided into 3 groups according to ci.

this study will be done in guangzhou red cross hospital .the investigators study 160 patients aged from 45 to 70 years,weight from 48 to 68kg classified as american society of anesthesiologists (asas) physical status ⅰ-ⅱ who will be candidate for posterior decompression of vertebral canal,discectomy and internal fixation by pediclescrew(one centrum).the investigators excluded patients with cardiovascular and cerebrovascular diseases,hepatic or renal dysfunction,and patients receiving drugs that interfere with coagulation before surgery. patients randomly divided into study group(group h,n=120)and control group (group c,n=40).the study group according to ci(cardiac index) levels of intraoperative hypotension period(mean of ci at t2,t3,t4) were divided into three groups: 1st group: ci: 1.5-2.0 l /(min•m2), 2nd group: ci: 2.0-3.0 l /(min•m2), 3rd group: ci: 3.0-4.0 l /(min•m2),and which ci \ 4.0 was eliminated the experimental group, which, in control group, ci\ 4.0 was eliminated the experimental group.

Eligibility criteria:
inclusion criteria: 1. aged between 35 and 70 years 2. patients, undergoing canal decompression, intervertebral disc extraction and pedicle screw fixation (1 vertebral body) exclusion criteria: 1. history of cardiovascular function 1. congestive heart failure \[chf\] 2. coronary artery disease \[cad\] 3. cerebrovascular insuffiency) 2. poorly controlled arterial hypertension 3. pre-existing coagulation defects 4. patients taking anticoagulatory medication including aspirin 5. patients taking corticosteroid therapy

Keywords: controlled hypotension cardiac output on blood loss surgical field oxygen supply oxygen consumption
7.0t magnetic resonance imaging study of parkinson's disease

Conditions: Parkinson's Diseases; MRI

Summary: this clinical trial study is conducted to detect the imaging characteristics of the patients with parkinson's diseases (pd) by 7-tesla (7t) magnetic resonance imaging (mri).

in this study,we explored the imaging characteristics of pd. first, with the advantage of 7t, we detect the slight changes of pd with short diseases history compared with the healthy. second, we investigate the different imaging characteristics in subtypes of pd, finding the effective neuroimaging biomarkers to distinguish different subtypes of pd. finally, we take long time follow-up to evaluate the correlation between the imaging changes and clinical score alteration in pd.

Eligibility criteria:
inclusion criteria: * the patients with pd who was diagnosed by the experienced neurologist specializing in movement disorders exclusion criteria: * the patients with brain disorders such as cerebrovascular disease, brain tumors, epilepsy, other neurodegenerative disease; * psychiatric disorders with impaired cognitive function; * contraindications to mri.
effects of manual therapy in strenght, pain and functional capacity for sport related groin pain

Conditions: Osteitis Pubis; Athletic Pubalgia

Summary: athletic osteitis pubis is a pathologic entity that can cause functional impairment. scientific evidence have noticed that athletes experiment pain and a decrease on strength. moreover, this symptomathology can affect daily life and functionality. there is no scientific evidence about the influence of manual therapy (mt) as a single treatment to improve this condition. the investigators decided to conduct a randomized controlled trial to compare the effects of a mt technique with placebo technique.


Eligibility criteria:
inclusion criteria: * athletes diagnosed with osteitis pubis stage 1 with at least 3 months of evolution. * internal rotation rom limited. * positive provocation pain tests. exclusion criteria: * pain due to intraarticular hip pathology. * hip pain due to inflamatory diseases. * previous surgical interventions in hip, pelvis or lumbar spine. * mri results or provocation pain tests inconcluyent
inca - intervention and neuropsychology in cannabis abuse

Conditions: Marijuana Abuse

Summary: inca (intervention and neuropsychology of cannabis abuse) is a study combining two research goals. one is to study efficacy of a short intervention the 'problem profile intervention', which utilizes individual feedback from a 'substance problem check-up'. subjects will randomly receive the 'problem profile intervention' or the who brief intervention, a brief intervention, which has been shown to be efficacious. currently efficiency studies are under way. the who brief intervention has been translated into german by our group. in contrast to most other cannabis intervention studies the current study is focussed on cannabis abusers not so much cannabis-dependent subjects. a total of 160 subjects are to be recruited. half of them will randomly receive either the problem profile intervention or the who brief intervention (active control). a total of 25% of subjects from each group will be placed on a 3 months waiting list before receiving the intervention (inactive control). intervention outcome will be assessed three months, six month and 12 months after the intervention. we hypothesize cannabis use to be reduced by 25% by the 'problem profile intervention'. the second aim of the study is to study mechanism of substance abuse. initial results from own studies and data from other groups point to executive cognitive functions as a subtle but important factor that can be compromised in cannabis users (verdejo-garcia et al., 2004; garavan and stout, 2005). using an fmri-study, we intend to examine a subgroup of our subjects on a specific aspect of executive functioning that has recently received major interest in drug research: decision-making capability, or risk-taking behaviour, respectively (e.g. ernst and paulus, 2005).


Eligibility criteria:
inclusion criteria: * assist-score for cannabis consume ≥ 4 ≤ 26 * german mother tongue (or comparable level) exclusion criteria: * major current psychiatric disorder (e.g. psychosis) * addiction to other illegal drugs or alcohol * recent or current intravenous drug use * cns-affecting medication * current psychotherapy, other treatment for substance use disorder exclusion criteria for fmri-part: * left-handedness * medication (birth control pill, thyroid gland hormones possible) * internistic illnesses (hypertension, diabetes, diseases of lungs) * metallic implants (cardiac pacemaker, ferromagnetic object implanted through surgical intervention or accident, large-area tattoos) * history of serious trauma * claustrophobia * gestation
best surgical technique for optimal lead placement in sacral neuromodulation - a comparative cadaver study

Conditions: Faecal Incontinence

Summary: sacral neuromodulation (snm) is an established treatment option for patients with faecal incontinence. the location of the stimulating electrode is considered to be essential for treatment success. the purpose of this study was to evaluate the position of snm electrodes after using the conventional implantation technique and to compare our results with those of the preliminary study, where the standardised fluoroscopy-guided implantation technique was used. in this cadaver study, snm electrodes will be implanted bilaterally in 5 lower body specimens. after electrode placement the pelvis was dissected to describe the exact position of the snm electrodes.

sacral neuromodulation (snm) is an established treatment option for patients with faecal incontinence. the location of the stimulating electrode is considered to be essential for treatment success. the purpose of this study was to evaluate the position of snm electrodes after using the conventional implantation technique and to compare our results with those of the preliminary study, where the standardised fluoroscopy-guided implantation technique was used. however, to date no studies exist comparing different surgical techniques. the present cadaver study was designed to assess the distance between lead and sacral nerves by comparing two different surgical techniques: the new fluoroscopy guided "h" technique and the commonly conducted non radiological lead implantation using anatomical landmarks. in this cadaver study, snm electrodes will be implanted bilaterally in 5 lower body specimens.afterwards the cadaver will be dissected and the exact location to the nerve, as well as a perforation of the sacral fascia will be noted. the results will be compared to the preliminary study of mueller et al., where they used the new fluoroscopy guided "h" technique in five cadavers.

Eligibility criteria:
inclusion criteria: * cadaver study * all of these individuals had donated their bodies to medical education and research in form of an informed consent. exclusion criteria: * none