cyrilzakka/clinical-trials huggingface dataset:
Effects of Lumbar PENS and Exercise in Older Adults With Chronic Low Back Pain

The purpose of this study is to determine whether a form of electrical acupuncture, called percutaneous electrical nerve stimulation (PENS), can reduce pain and disability in older adults with chronic low back pain (LBP). This study will also determine the effects of general conditioning and aerobic exercise (GCAE) on chronic LBP.

Each year, a significant number of elderly individuals experience at least one episode of LBP. When LBP becomes chronic, it can lead to functional and emotional impairment, increased health care utilization, and decreased quality of life. Standard treatment for LBP typically consists of non-opioid analgesics and physical therapy; however, analgesic-associated morbidity in older adults often limits their utility. This study will determine the efficacy of PENS treatment, a neuroanatomically guided form of electroacupuncture, and exercise in reducing pain in older adults with chronic LBP.

Participants will be randomly assigned to one of four treatment groups: PENS alone, PENS placebo, PENS plus GCAE, or PENS placebo plus GCAE. The treatments will be given twice weekly for 6 weeks. Pain intensity, physical function, health care utilization, and psychosocial function will be assessed with self-report and performance-based measures. These assessments will be conducted at study start, immediately after the last treatment session, and 6 months after study completion.

Eligibility Criteria:
Inclusion Criteria:

* Low back pain for at least 3 months
* Able to walk without an assistive device (e.g., cane or walker)

Exclusion Criteria:

* Serious underlying illness causing back pain
* Nerve root compression
* History of back surgery
* Has pacemaker
* Current use of blood thinners
* Major psychiatric disorder
* Chest pains or heart problems that interfere with daily activity
* Fibromyalgia
Clinical Study on the Treatment of Postpartum Anemia With Compound E Jiao Jiang(cEJJ）

The goal of this clinical trial\] is to compare the effect of compound E Jiao Jiang(cEJJ）combined with iron decoction on postpartum anemia.The main questions it aims to answer are:

To evaluate the effectiveness of compound E Jiao Jiang(cEJJ） in the treatment of postpartum anemia.

To evaluate the safety of compound E Jiao Jiang(cEJJ） in the treatment of postpartum anemia.

To explore the effect of compound ejiao decoction on improving anxiety, depression, sleep and fatigue in postpartum anemia patients.

Participants will be randomly assigned (like flipping a coin) to either the trial group or the control group (with a 50% chance of being assigned to either group), where the trial group will receive the compound E Jiao Jiang(cEJJ） + ferrous succinate tablet, and the control group will receive the compound E Jiao Jiang(cEJJ）placebo + ferrous succinate tablet. The compound E Jiao Jiang(cEJJ）placebo is the same/similar to the compound E Jiao Jiang(cEJJ） in terms of appearance, smell and taste, but has no therapeutic effect.And participants need to return to the research center on time for relevant examinations according to the protocol requirements.


Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with mild or moderate anemia (70g/L≤Hb \< 110g/L) within 1 week postpartum and suitable for oral drug therapy;
2. Age 18-45 years old (including 18 and 45);
3. Those who do not use other iron agents and Chinese medicine/Chinese medicine preparations that have the effect of invigorating qi and nourishing blood during the study;
4. Sign the subject's informed consent voluntarily.

Exclusion Criteria:

1. Postpartum hemorrhage and blood transfusion treatment;
2. Those who received intramuscular/intravenous iron therapy or transfused blood products/human blood albumin and other plasma volume dilators within 3 months prior to screening;
3. Patients who have taken blood tonics within 1 week before screening, including other iron preparations and Chinese medicine or Chinese medicine preparations;
4. People with previous blood diseases such as sickle cell anemia, thalassemia, aplastic anemia, megaloblastic anemia;
5. Severe preeclampsia during pregnancy;
6. Abortion occurs in this pregnancy;
7. Patients with a serious digestive disease, cardiovascular disease, immune system disease, or serious mental disorder that the investigator believes may adversely affect the safety of the subject and/or the effectiveness of the investigational drug;
8. Severe hepatic and renal insufficiency (ALT \>2×ULN, aspartate aminotransferase (AST)\>2×ULN, Urea (Urea)/ urea nitrogen (BUN)\>2×ULN, creatinine (Cr)\>1×ULN);
9. People with a history of alcoholism, drug abuse, or drug abuse;
10. Allergic to the experimental drug or known ingredient;
11. Participants who had participated in other clinical trials within 3 months before screening;
12. Those who, according to the judgment of the investigator, consider it inappropriate to participate in this clinical trial.
Methionine and PBR28-PET (Peripheral Benzodiazepine Receptors) in Brain Metastases Following Radiosurgery

The goal of this protocol is to evaluate the potential of PET imaging of amino acid transport and microglial activation to improve the differentiation of tumor recurrence and radiation necrosis in patients with brain metastases after treatment with stereotactic radiosurgery (SRS) who have re-growing lesions. These state-of-the-art imaging tools will be used in combination with standard magnetic resonance imaging (MRI), MR spectroscopy (MRS) and FDG-PET (fluorodeoxyglucose).

The investigators hypothesize that by using two different PET tracers, one sensitive to tumor metabolic activity, and one sensitive to inflammatory processes, investigators can separately identify metabolically active tumor from radiation necrosis related inflammation. This can be accomplished with quantitative assessments of tracer uptake using kinetic modeling techniques, as well as by high-resolution imaging to assess the distribution of tracer uptake in the tumor region. All participants in the study will have the receive the same diagnostic tests.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years with brain metastases from melanoma or non-small cell lung cancer
* Patients must have had SRS and regrowth in at least one lesion \> 0.5 cm in greatest dimension and fall into one of two categories: a) patient is deemed clinically appropriate for surgical intervention (biopsy or craniotomy) OR b) patient is asymptomatic and has a life expectancy of \> 6 months so that serial follow-up imaging is appropriate
* Willingness to participate in imaging studies
* Able to give informed consent

Exclusion Criteria:

* Subjects with history of prior radiation exposure for research purposes within the past year, such that participation in this study would place them over the FDA limits for annual radiation exposure. This guideline is an effective dose of 5 rem received per year.
* Subjects who are pregnant or currently breastfeeding
* Women of child-bearing age who are sexually active, unless they agree to two forms of contraception, and have a negative urine pregnancy test at screening and on the days of the PET imaging
* Patients unable to undergo MRI with gadolinium-based contrast for standard clinical reasons which include:
* Cardiac pacemaker, aneurysm clip, cochlear implants, Intra Uterine Device (IUD), shrapnel, neurostimulators, defibrillator, artificial heart valve, or history of metal fragments in eyes.
* Pregnancy
* Body size too large for closed MRI
* Known hepatic fibrosis.
* Claustrophobia
* Contraindication to MR contrast agents: eGFR (epidermal growth factor receptor) \< 30 by the Cockcroft- Gault formula if \> 60 years old or with chronic renal disease
* Anaphylactic allergy to gadolinium
Influence of Severe Heart Failure to Function and Molecular Biological Parameters of Catabolism in the Human Diaphragm and Peripheral Skeletal Muscle

Project aim is to quantify the influence of a severe therapy-refractory heart failure caused by ischemic or dilative myocardiopathy on the function of the diaphragm, its molecular biological parameters and on the M. vastus lateralis. The control group consists of patients with coronary artery disease (CAD) and normal left ventricular ejection fraction indicated for coronary artery bypass graft surgery (CABG) Differences in the geneses of heart failure (ischemic vs. dilative cardiomyopathy) will be evaluated during analysis. The ubiquitin-proteasome signaling pathway is considered as a central issue for the mechanism of the analyses muscle catabolism.


Eligibility Criteria:
Inclusion Criteria:

inclusion criteria Group A:

* age 40 - 70 years
* Restricted left ventricular pump function left ventricular ejection fraction (LVEF) \> 35% on the basis of ischemic cardiomyopathy (ICM) and restricted resting cardiac output (CI\> 2.4 L / min / m²)
* or restricted maximal oxygen uptake (VO2max\> 17 ml / min / m²)
* Duration of heart failure\> 1 year
* Maximum of individual heart failure therapy
* Heart team decision to LVAD Implantation

inclusion criteria Group B:

* age 40 - 70 years
* Restricted left ventricular pump function (LVEF) \> 35% on the basis of dilatative cardiomyopathy (DCM) and restricted resting cardiac output (CI\> 2.4 L / min / m²)
* or restricted maximal oxygen uptake (VO2max\> 17 ml / min / m²)
* Duration of heart failure\> 1 year
* Maximum of individual heart failure therapy
* Heart team decision to LVAD Implantation

inclusion criteria Group C:

* age 40 - 70 years
* coronary heart disease with indication for elective, coronary artery bypass surgery
* normal left ventricle (LV) pumping function LVEF\> 50%
* stable clinical situation (no cardiac decompensation within the last 6 months)

Exclusion Criteria:

* Mechanical ventilation within the last 3 months
* Forced Expiratory Pressure (FEV1) \<70% of the norm and / or therapy with α antagonists, β-mimetics or inhaled corticosteroids for the treatment of a lung disease
* Pulmonary fibrosis
* elevated diaphragm in the ultrasound or X-ray diagnosis or known paresis of the phrenic nerve
* chronic kidney disease (CKD) stage 4 and 5, i.e. glomerular filtration rate (GFR) \<30ml / min / 1.73m and / or dialysis
* Acute renal failure
* Treatment with immunosuppressive agents
* Hepatic insufficiency Child-Pugh B and C
* Higher grade ventricular arrhythmias (Lown IV b)
* Acute myocardial infarction (less than three months)
* Decompensated Vitium cordis
* Age \<40 years and\> 70 years
* Pregnancy
Metabolic, Endocrine and Appetite-related Responses in Healthy, Adolescent Males After Acute and Daily Milk Consumption

Comprising two experiments, the investigators assessed the metabolic, endocrine and appetite-related responses to acute (1-d, part 1) and daily mid-morning milk consumption (28-d, part 2) in adolescent males (15-18 y).

The aims of the present study were twofold. Firstly, this study sought to examine the acute (1-d) effects of mid-morning milk consumption on subsequent metabolic, endocrine and appetite-related responses relative to an isoenergetic and isovolumetric serving of fruit-juice (part 1). Considering the putative mechanisms of milk consumption on appetite, feeding behavior and metabolism no studies are available that have explored the impact of daily milk or dairy food consumption on the above mentioned constructs in children and adolescents. This study therefore also aimed to compare the effect of daily (28-d) mid-morning milk or fruit-juice consumption on the above mentioned constructs (part 2).

Eleven adolescents participated in part 1 of this study and completed two trials (milk or fruit-juice mid-morning snack) in a randomized crossover design. For part 2, a parallel design with two intervention groups was employed. Participants were randomly allocated to groups, and received either a milk (n = 10) or an isocaloric and isovolumetric fruit-juice (n = 9) mid-morning snack for 28-d. On laboratory visits (for both part 1 and 2) participants remained at rest for 180 min. During this time, circulating concentrations of GLP-17-36, glucagon, insulin, leptin and blood glucose were determined. Measures of energy expenditure, substrate metabolism and subjective appetite were also collected. At 180 min, a homogenous ad libitum pasta meal was provided. For the remainder of the study day, subsequent energy intake was recorded utilizing a combined weighed self-reported food record and 24-h dietary recall technique.

Eligibility Criteria:
Inclusion Criteria:

1. Male
2. Non diabetic
3. 15-18 yrs

Exclusion Criteria:

1. Are outside of the stipulated age range (15-18 years old)
2. A diabetic
3. Hold an aversion/dislike to milk, milk based products and the test meals provided.
4. Are known to be lactose intolerant
5. Currently taking any form of medication known to affect taste, smell and appetite
6. Female
Comparison of Spontaneous Ventilation Time in Air Without Desaturation After Positive Pressure Extubation Versus Aspiration Extubation When Awakening From General Anesthesia

The primary objective is to show that positive pressure extubation improves oxygenation immediately after extubation compared to extubation via "aspiration" by evaluating and comparing the onset time of desaturation during spontaneous ventilation during awakening following general anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient is available for 1 hour of follow up
* ASA 1 to 3
* The patient is schedules for orthopedic surgery (limbs) with general anesthesia

Exclusion Criteria:

* The patient is participating in another study
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* The patient is pregnant
* The patient is breastfeeding
* Chronic respiratory insufficiency
* Cardiopathy
* Obstructive sleep apnea
* Two or more predictive criteria for difficult mask ventilation (age \> 55 years, toothless, beard, snorer, BMI \> 26)
* No predictive criteria for difficult intubation (SPIDS \<= 10)
Adaptive Servo-ventilation Monitoring Study

Sleep disordered breathing is very common in patients with chronic heart failure with reported prevalence rates of 50-75%. Adaptive Servo-Ventilation (ASV) can be used to treat sleep apnea in these patients. This is an observational study to document changes in respiratory parameters in HF patients using ASV for a period of 12 months.


Eligibility Criteria:
Inclusion Criteria:

More than 18 years old Chronic heart failure (at least 12 weeks since diagnosis) according to the currently applicable guidelines NYHA Class III or IV at the time of inclusion with at least one hospitalization for heart failure in the last 12 months Moderate to severe sleep apnea (AHI ≥ 15/hour). Already using or willing to use ASV-therapy and able to tolerate the mask treatment

Exclusion Criteria:

Planned or scheduled heart valve interventions and/or CABG Untreated or therapy refractory Restless Leg Syndrome Patients for whom the use of positive airway pressure therapy may be contra-indicated because of symptomatic hypotension or significant intravascular volume depletion or pneumothorax or pneumomediastinum Pregnancy
Evaluation of the Accuracy of the POGO Score

A classification method describing the larynx appearance during laryngoscopy accepted by all anesthetists has not been defined yet. In one study, it was shown that anesthetists mis classed the glottis image by 50%. The most commonly used classification method is the Cormack Lehane (CL) classification. This classification classifies the larynx appearance during direct laryngoscopy form 1 to 4. The modified CL classification is criticized as it does not predict difficult intubation and especially grade 2 is operator dependent and partial view is not well defined. The numerical expression of the percentage of the glottic aperture (POGO = percentile of glottic opening) is another score. In this score, A POGO score of 100% accounts for full visualization of the larynx starting from anterior commissure to the posterior cartilage, while 0% indicated a complete absence of glottic opening.

The use of a standard and effective classification method will facilitate and accelerate communication between anesthetists in difficult life-threatening situations such as difficult airway / difficult intubation / difficult ventilation and contribute to patient safety. The use of common terminology can also facilitate the evaluation of the performance of intubation tools.

The aim of this study was to evaluate the accuracy and intra and inter rater reliability of the POGO score.

Anesthesiologist will be asked to score still images of laryngeal views, which will be obtained from patients requiring intubation for general anesthesia, after obtaining written informed consent.

The images of the larynx will be captured first with the Macintosh blade and thereafter with the D blade. A group of independent anesthesiologist will score these images with the Cormack Lehane and POGO scores. The set of images will be prepared from patients with both difficult and normal airway anatomy. Some images in the series will be repeated to assess intra rater variability.

The anesthesiologist will be asked to rate 20 images both with the CL and POGO scores.

The experience of the raters in airway management, their experience with videolaryngoscopy and scoring systems used currently when documenting videolaryngoscopy and demographic data will be also obtained.

The POGO scores of the participants and investigators will be compared.

The outcome of interest is the correct POGO score rate of the participants.

Eligibility Criteria:
Inclusion Criteria:

* Patients receiving general anesthesia

Exclusion Criteria:

* Emergency surgery
DC Vaccine Combined With CIK Cells in Patients With Renal Cell Carcinoma

The aim of this Phase I/II study is to evaluate the safety and efficacy of dendritic cells (DC) vaccine combined with cytokine-induced killer (CIK) cells in patients with renal cell carcinoma. Experimental recombinant adenovirus-transfected DC, which engineered to express MUC1 and Survivin are used for DC-based immunotherapy. Based on the results of our previously performed preclinical study with DC vaccine combined with CIK cells, the investigators plan to perform the clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years at time of consent
* Histopathologically confirmed diagnosis of renal cell carcinoma
* Received standardized treatment of renal cell carcinoma
* Interval between the last standardized treatment and DC/CIK treatment ≥ 4weeks
* KPS (Karnofsky performance scale) \>60
* Patient's written informed consent
* Predicted survival \>3 months
* No severe viral or bacterial infections

Exclusion Criteria:

* Receiving chemotherapy, radiotherapy or other therapy
* Patients with other malignancies and infectious diseases
* Pregnant and breast-feeding patient
* Currently participating in another clinical trial
* Unfit for participating in this clinical trial in investigators' opinions
Surgical Resection Outcomes in Patients With Brain Metastasis

While many studies have investigated the prognostic factors for patients undergoing surgical resection for primary brain tumors, decision-making for patients with brain metastasis (BM) is more complex because of their higher burden of comorbidities compared to those with primary brain tumors. In addition, although various prognostic indicators have been identified to predict prognosis in several types of cancer, such as the neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), prognostic nutritional index (PNI), and systemic immune-inflammation index (SII), limited studies have yet determined which group of patients would yield beater survival outcome after surgical resection for BM. This study aimed to investigate the impact of patient and perioperative characteristics and prognostic indicators on survival outcome of patients undergoing surgical resection of BM.


Eligibility Criteria:
Inclusion Criteria:

1. patients with Clinical diagnosis of brain metastasis
2. patients who underwent craniotomy surgery for brain metastasis

Exclusion Criteria:

1. patients with insufficient data for associated factors
2. patients who underwent stereotactic biopsy for brain metastasis
3. patients who did not undergo craniotomy surgery for brain metastasis
Pregnancy Complications - A Probiotic Interventional Study

Investigators hypothesize that

a) probiotics decrease the overall inflammatory state in the pregnant woman, especially in women with high risk pregnancies.

The main of the Project is to determine if dietary supplementation intake of probiotics are associated with a decreased inflammatory response in pregnant women, especially those with a history of previous preterm birth or preeclampsia, in a randomized clinical trial. Investigators also want to further investigate the relationship between intake of probiotics and the degree of inflammation in different compartments during pregnancy to see how the probiotic components affect the inflammatory state in the women.

Eligibility Criteria:
Inclusion Criteria:

* Maternal age \> or = 18 y
* Singleton pregnancy
* Nulli or multiparous without maternal intercurrent diseases or pregnant women with a history of spontaneous preterm delivery or pregnant women with a history of preeclampsia.

Exclusion Criteria

* Multiple pregnancy
* Gestational age \> 17+6 weeks at first visit
* Chronic intermittent diseases (e.g. diabetes mellitus, systemic lupus erythematosus, rheumatoid arthritis, Chron disease, ulcerative colitis)
* Uterus malformations
* Immunomodulatory medication
* Hormonal treatment (e.g. crinone, progesterone)
* Subject disagrees to stop intake of other products containing probiotics during study time.
* Subject is unable to provide written informed consent