cyrilzakka/clinical-trials huggingface dataset:
The Effect of Intradialytic Parenteral Nutrition on Nutritional Status and Quality of Life in Hemodialysis Patients

Protein-energy wasting (PEW), a hypercatabolic state characterized by loss of muscle mass and fuel reserves, is highly prevalent in hemodialysis patients. Nutritional status and body composition are closely linked to morbidity, mortality and quality of life. Lean tissue mass (LTM) appears to be the best read-out for the association between nutritional status and outcomes. Intradialytic parenteral nutrition (IDPN) is occasionally used with the aim to reduce loss of LTM, but its efficacy has not been established. The goal of this study is to study the effect of IDPN on changes in LTM in hemodialysis patients.


Eligibility Criteria:
Inclusion Criteria:

* Undergoing chronic hemodialysis

Exclusion Criteria:

* Life expectancy \< 6 months
* Planned kidney transplant within 4 months
* Severe overhydration leading to respiratory insufficiency
* Parenteral nutrition within four weeks prior to screening
* Severe hepatic insufficiency
* Pregnancy
* Unipolar pacemaker with a very low sensitivity threshold
* Active treatment for infection
* Acute myocardial infarction
* Circulatory shock
* Hypersensitivity for any Olimel N12 ingredient or excipient
The Effect of Wavelet Index in Monitoring the Sedation Depth of Remimazolam Besylate

To explore the sedative effect of remimazolam in patients undergoing spinal anesthesia without pain stimulation. Both the Modified Observer's Assessment of Alertness/Sedation (MOAA/S) and the Wavelet index (WLi) were used to monitor the depth of anesthesia of remimazolam, and exploring the correlation and consistency between MOAA/S score and WLi value at the same time.

Patients undergoing spinal anesthesia were received remimazolam besylate for sedation continuously. Both the Modified Observer's Assessment of Alertness/Sedation (MOAA/S) and the Wavelet index (WLi) were used to monitor the depth of anesthesia of remimazolam, and exploring the correlation and consistency between MOAA/S score and WLi value at the same time.

Eligibility Criteria:
Inclusion Criteria:

* ASA was classified as I-III
* The operation time was less than 120 minutes
* Informed consent is signed by all study participants
* Elective lower extremity surgery under spinal anesthesia was performed

Exclusion Criteria:

* Pregnant or lactating women
* Patients with Difficult Airways
* History of severe neurological and muscular diseases and mental retardation
* Patients with severe respiratory and circulatory diseases, including acute heart failure. Unstable angina pectoris. Resting ECG heart rate \<50 beats/min. QTc: ≥470ms in men and ≥480ms in women. Third degree atrioventricular block. Severe arrhythmia. Moderate to severe heart valve disease. Chronic obstructive pulmonary disease. A history of severe asthma.
* Abnormal liver and kidney function: ALT and/or AST exceeding 2.5 times the upper limit of the medical reference range
* Take diazole drugs and/or opioids in one month or nearly three months
* Patients who were allergic to or contraindicated to benzodiazepines, opioids, propofol, flumazenil, naloxone, etc
* Patients who could not monitor the depth of anesthesia for various reasons
Bilateral Brain Stimulation in Trauma Therapy

Comparatively studied the effects of Eye Movement Desensitization and Reprocessing (EMDR) bilateral brain stimulation in trauma therapy.

A randomized, parallel, before-after, blind study was performed.

Comparatively studied the effects of Eye Movement Desensitization and Reprocessing (EMDR) bilateral brain stimulation in trauma therapy.

A randomized, parallel, before-after, blind study was performed. Thirty nine subjects were randomly distributed to two groups: one session of EMDR psychotherapy standard and other with EMDR standard protocol without its typical brain bilateral stimulation. The results of the Beck scales for anxiety, depression and hopelessness and the impact of events test were compared between groups.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria for the study were to be a university student, over 18 years old, to have a complaint associated to a traumatic life event and to have accepted to participate of the study.

Exclusion Criteria:

* Exclusion criteria were the existence of untreated psychiatric disorders and the hypothesis of worsening of the subject's status as the number of sessions in this study was restricted to once.
Oligoantigenic Diet and Core Symptomatology of Children With Attention-Deficit /Hyperactivity Disorder (ADHD).

Fifty patients who diagnosed as ADHD syndrome according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM 5) Criteria aged from 6 to 16 years old will be assigned randomly into 2 arms: arm 1: the patients will follow food regimen that cover recommended daily allowance (RDA) for macronutrients and micronutrients suitable for their ages without any food restriction, arm 2: the patients will follow food regimen that cover (RDA) for macronutrients and micronutrients suitable for their ages based on Oligoantigenic diet (OAD). Psychiatric assessment will be done before intervention and after 3 months of intervention.


Eligibility Criteria:
Inclusion Criteria:

* Children fulfilled DSM (5) Criteria for ADHD syndrome aged from 6 to 16 years old on stable pharmacotherapy 8 weeks prior to enrollment with intention to maintain ongoing therapies constant throughout the trial.

Exclusion Criteria:

* Presence of other medical conditions as chronic medical illness or other neuropsychiatric disorders
* Intelligence quotient (IQ) of patients less than 80%.
IVROP ReadyforLIFE Program Evaluation

The purpose of the Imperial Valley Regional Occupational Program (IVROP) ReadyforLIFE program evaluation is to determine whether primary (i.e., behaviors) and secondary (i.e., attitudes) outcomes improve for youth participants after completing the ReadyforLIFE program. Understanding the ways in which the IVROP ReadyforLIFE program supports healthy partner relationships and economic stability is important for those providing services to at-risk youth populations.

After being informed about the study and giving consent, participants will enroll in a program that collects data at enrollment, at the end of the program, and 12 months following program enrollment. The length of the program ranges from four weeks up to one year, depending on the setting and the number of optional workshops students opt to receive. Research questions in this study are framed by a descriptive evaluation design to assess whether outcomes improve for at-risk youth who participate in the IVROP ReadyforLIFE program. Primary and secondary outcomes are assessed before and one year after participants complete core curricula - Relationships Smart Plus, Mind Matters, and Money Habitudes (pre to follow-up). Primary outcome measures will indicate whether behavior improved for healthy partner relationships and financial stability. Secondary outcome measures will indicate whether improvements were made in the attitudes and expectations that facilitate and reflect behavior for healthy partner relationships and financial stability.

Eligibility Criteria:
Inclusion Criteria:

* At-risk youth (foster/justice involved, immigrant household, undocumented, LGBTQ)
* High school age
* Residing in the Imperial Valley, CA

Exclusion Criteria:

* Individuals who are 18 and above and out of high school
* Individuals who reside outside of Imperial Valley, CA
Incision and Drainage Versus Needle Aspiration in Soft Tissue Abscesses

The incidence of skin and soft tissue infections has increased dramatically over the last decade, in part due to increased prevalence of community-acquired methicillin-resistant Staphylococcus aureus (CA-MRSA). Incision and drainage (I\&D) is considered the primary intervention, however some clinicians prefer ultrasound guided needle aspiration (US Asp). The investigators performed a randomized trial comparing US Asp to I\&D for uncomplicated skin and soft tissue abscesses, with a subgroup analysis of patients with CA-MRSA.


Eligibility Criteria:
Inclusion Criteria:

* presenting to emergency department with skin abscess
* abscess required surgical drainage
* healthy appearing

Exclusion Criteria:

* pregnant
* unable to give consent
* abscess located in oral cavity
* abscess located on genitalia
* abscess located intra-gluteal at coccyx
"Effectiveness of School-based Substance Abuse Prevention Programme Among Adolescents .

The objectives of the study is to

1. "to explore the perception of teachers, parents \& students in the prevention of substance abuse among adolescents".
2. "to develop and determine the effectiveness of a School-based substance abuse Prevention Programme (SSPP) on awareness, attitude, peer pressure, and life skills towards prevention of substance abuse".

In this study, SSPP refers to a Bilingual Multicomponent Training Programme which includes psychoeducation and video-assisted teaching to enhance awareness of substance abuse, role-play to develop a positive attitude towards prevention of substance abuse, Case based scenario to increase resistance to peer pressure and storytelling and demonstration to increase life skills towards prevention of substance abuse among adolescents of selected schools of Pokhara, Nepal.

DETAILED METHODOLOGY

Phase I:

* Research Design: Qualitative
* Research Setting: Selected public schools of Pokhara, Nepal
* Population: Teachers, Parents, and Students of Pokhara, Nepal
* Samples: Selected Teachers, Parents \& students
* Sample Size: 38 (The sample will be collected till data Saturation)
* Data collection Technique: Focus group discussion
* Data collection Tool: Focus group lead questions
* Data Analysis: Thematic analysis (Atlas.ti) Phase II Research design: Cluster Randomized Trial Randomization method: Cluster Randomization Research Setting: Selected public schools of Pokhara, Nepal Population: Adolescent students of Pokhara, Nepal Sample: Selected Adolescents, who are in the age group 13-15 years old and studying in 8th \& 9th grades Variables
* Independent variables: School-based Substance abuse Prevention Programme (SSPP)
* Dependent variables: awareness, attitudes, peer pressure, and life skills related to prevention of substance abuse.
* Demographic variables: age in years, gender, religion, education/grade, family type, residence, number of siblings, education of parents, occupation of parents, sources of information, history of substance abuse in the family.

Sample size: 210

The expected outcomes of the study is to enhance awareness towards prevention of substance abuse,develop a positive attitude towards the prevention of substance abuse,develop drug refusal skills among adolescents,improve life skills and helps in th reduction of drug abuse behaviour adolescents

Eligibility Criteria:
Inclusion Criteria:

* Adolescents of 13-15 years age group.
* Those who are studying in selected public Schools of Pokhara, Nepal.

Exclusion Criteria:

* o Adolescents who are not willing to provide informed consent (assent) and parental consent.

  * Adolescents who do not belong to Nepal.
  * Adolescents who are absent during data collection
Virtual Bronchoscopy (VB) vs. Endobronchial Ultrasound (EBUS) Guided Mediastinal Sampling

The study has been designed to evaluate the clinical application of the new virtual bronchoscopy (VB) -based system for transbronchial sampling of the mediastinal masses or enlarged lymph nodes. The software uses data from thorax CT scan and enables airway segmentation and reconstruction simultaneously with predefined mediastinal targets. The most suitable sites for transbronchial needle aspiration are displayed on the internal surface of the airways showed in VB mode.

The diagnostic yield of the new system-assisted TBNA will be compared to the reference method (EBUS-TBNA). The study group includes patients with mediastinal mass or lymph node enlargement in whom diagnostic bronchoscopy and TBNA can be applied as diagnostic methods. Both, virtual bronchoscopy guided transbronchial needle aspiration (VB-TBNA) and EBUS-TBNA of the mediastinal targets are performed during the same diagnostic bronchoscopy. Cytologic material from VB-TBNA and EBUS-TBNA is evaluated by two independent pathologists blinded to the method used to obtain the sample. Diagnostic yield and adequacy of aspirates obtained with the two methods will be assessed and compared.


Eligibility Criteria:
Inclusion Criteria:

* provided informed consent
* mediastinal mass or lymph node enlargement that requires bronchoscopy and transbronchial sampling
* quality of the CT scan which allows bronchial tree and mediastinal target segmentation and reconstruction

Exclusion Criteria:

* Age below 18 years
* known contraindications for bronchoscopy and/or mediastinal sampling, e.g. coagulation disorders
Ketogenic Diet Survey in Patients With McArdle Disease (GSDV)

The purpose of this survey is to report experiences with variants of a ketogenic diet in a group of individuals diagnosed with McArdle disease (glycogen storage disease type V). Further more the survey will report on physical activity, fatigue, sleep and quality of life in this cohort.

Currently, there is no satisfactory treatment for McArdle disease. The limitation in people with McArdle disease is due to a limited availability of energy in the muscle due to affected carbohydrate metabolism. A key element in improving muscle function is therefore to introduce alternative energy sources. Ketone bodies are a well-known source of energy for both brain and muscle. Ketone bodies are produced during fasting or when following a ketogenic diet. A ketogenic diet is a diet high in fat and low in carbohydrates. The classic ketogenic diet contains up to 90% fat, but there are several alternative diets with less fat, including a modified ketogenic diet, Atkins diet, LCHF (low carb high fat), OMAD (one meal a day) and more. This survey will collect information on all variations. The rationale for a ketogenic diet for persons with McArdle disease makes good sense in theory, as the diet would contribute with a new source of energy (ketone bodies) independent of the affected carbohydrate breakdown. However, evidence is sparse on whether the diet actually works. The primary purpose of this survey is to report experiences with variants of the ketogenic diet in a group of individuals diagnosed with McArdle disease. Secondarily this survey will collect information on physical activity, fatigue, sleep and quality of life in this cohort

Eligibility Criteria:
Inclusion Criteria:

* Verified GSDV diagnosis

Exclusion Criteria:

* Age under 18 years
Healing Abutment Materials on Matrix Metalloproteinase-8 Level in Peri-implant Crevicular Fluid

Numerous materials are nowadays used in the fabrication of healing abutments to be used for dental implants. soft tissue response to different healing abutment materials is still to be unraveled. the Aim of this study is to compare the soft tissue response to titanium stock healing abutments to customized composite healing abutments through assessing the level of matrix metalloproteinase-8 in the peri-implant crevicular fluid


Eligibility Criteria:
Inclusion Criteria:

* Patients with no systemic and/or oral health disease
* absence of any lesions in the oral cavity
* wide band of keratinized tissue more than 1mm at implant site

Exclusion Criteria:

* smoking more than 20 cigarettes per day
* localized radiation therapy of the oral cavity,
* antitumor chemotherapy, liver diseases, blood diseases, kidney diseases, immunosuppressed patients, patients taking corticosteroids, pregnancy, inflammatory and autoimmune diseases of the oral cavity
Tissue Distribution of F18-FDG Labelled Autologous Bone Marrow Derived Stem Cells in Patients With Type 2 DM

Investigators purpose is to track stem cells in vivo in the type 2 diabetes mellitus patients after the same have been labelled with positron emission tomography tracer F18-FDG; as it is assumed that the therapeutic outcome will profoundly depend on the delivery of these cells to pancreas. Biodistribution and quantification studies will be done at 30 minutes and 90 minutes of stem cell infusion.

Autologous bone marrow derived stem cells have a promising potential in regenerative medicine. In particular the past decade has garnered a great interest in cellular therapy for treating Type2 diabetes mellitus. The pertinent questions in regenerative medicine today are to know about the homing, survival, differentiation and functionality of the cells and based on these to find out the adequate administration methods and choose the optimal dose and cell types. Various modalities have been used in the preclinical and clinical trials. These include MRI,optical imaging in the form of bioluminescence and fluorescence, quantum dots, SPECT and PET/CT imaging. However the methods which are suitable for stem cell tracking in small animals are not easily translated for human trials. In humans PET/CT imaging with its reasonable resolution and unique ability to combine anatomical and functional imaging is considered to be the best bet yet. Hence we intend to label the autologous bone marrow derived stem cells with PET tracer F18-FDG and carry out biodistribution studies, our ultimate aim being to study how in vivo distribution of the cells affect therapeutic efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Patients with T2DM between 30 and 70 years of age.
* Failure to triple OHA and on stable doses of insulin for at least 3 months.
* On vildagliptin, pioglitazone and metformin for at least 3 months along with Insulin to maintain euglycemia.
* HbA1c of 6.5-7.5%
* Insulin requirement ≥0.4 IU/kg/d.
* Glutamic acid decarboxylase (GAD 65) antibody negative status.

Exclusion Criteria:

* Patients with T1DM or secondary diabetes.
* Patients with serum creatinine \> 1.5 mg/dl.
* Abnormal liver function tests (defined as value of transaminases \> 3 times the upper value of normal or serum bilirubin higher than normal for the reference value for the laboratory).
* History of pancreatitis
* Seropositivity for HIV, HBsAg and HCV.
* History of myocardial infarction or unstable angina in the previous 3 months.
* History of malignancy
* Patients with active infections.
* Female patients who are pregnant or lactating
Adenomyosis Patients With Infertility and Immunological Factors

Infertile patients with adenomyosis who met the inclusion and exclusion criteria, after signing the informed consent form, the researchers recorded the clinical information of the patients and initiated the in vitro fertilization-embryo transfer (IVF-ET) procedure. Peripheral blood was collected on the day of embryo transfer. And if the pregnancy test was positive at 14 days after embryo transfer, peripheral blood was collected at 21 days after the transfer and every 2 weeks thereafter until 12 weeks of gestation. By analyzing the changes of immune cells and molecules in the peripheral blood of the patients, role of immune factors in infertility combined with adenomyosis was further explored.

Adenomyosis is a common gynecological disease in women of reproductive age which is characterized by endometrial glands and stroma in the normal myometrium, accompanied by hypertrophy of the surrounding myometrial smooth muscle cells.The results of several studies showed that clinical pregnancy rate and live birth rate of in vitro fertilization-embryo transfer decreased in infertile patients with adenomyosis. This study intends to explore the immune-related mechanisms in infertile patients with uterine adenomyosis, with a view to finding effective clinical intervention targets for adenomyosis associated infertility, and providing new clues for the prevention and treatment of adenomyosis associated infertility. Peripheral blood was collected on the day of embryo transfer. And if the pregnancy test was positive at 14 days after embryo transfer, peripheral blood was collected at 21 days after the transfer and every 2 weeks thereafter until 12 weeks of gestation. The basic characteristics of the participants, such as age, body mass index, infertility type, infertility duration, gravida, parity times, basal follicle-stimulating hormone (FSH), anti-Müllerian hormone, uterine volume before IVF cycle, controlled ovulation hyperstimulation (COH) protocol, endometrial thickness, number of embryos transferred, transferred embryo type (cleavage embryo/blastocyst) were evaluated. Pregnancy outcomes of all patients were followed up. By analyzing the changes of immune cells and molecules in the peripheral blood of the patients, role of immune factors in infertility combined with adenomyosis was further explored.

Eligibility Criteria:
Inclusion Criteria:

* Patients were diagnosed as adenomyosis by transvaginal ultrasound scans (The criteria for sonographic diagnosis of adenomyosis are with 2 or more of the following: heterogeneous myometrial texture with the presence of globular asymmetric uterus, thickening of the anterior and posterior myometrial wall, irregular cystic areas within the myometrium);
* 18≤ age ≤ 40 years old at first outpatient visit in our Reproductive Center;
* with regular menstrual cycle.

Exclusion Criteria:

* Patients with intrauterine adhesion, uterine malformation, submucosal leiomyoma, or ≥ 5.0 cm in diameter leiomyoma;
* hydrosalpinx and systemic diseases;
* patients with other endocrine severe diseases, immune diseases, tumors and abnormal chromosomes in either partner.
Reverse Trendelenburg Positioning and Its Effect on Outcomes: a Retrospective Study of Consecutive Patients

The purpose of this study is to investigate whether intraoperative reverse Trendelenburg positioning decreases postoperative hypoxemia and perioperative pulmonary aspiration rates.

Intraoperative pulmonary aspiration can cause death and lead to morbidity. In addition, reliable estimates of aspiration rates are uncertain. In part, this ambiguity relates to the lack of prospective data. Relevant studies are retrospective chart reviews or results from voluntary reporting databases. Furthermore, aspiration diagnosis can be imprecise. The finding is certain when there is aspiration of bile or particulate matter from the tracheobronchial tree or there is endoscopic visualization. However, the diagnosis is presumptive when there is intraoperative or postoperative development of a new chest x-ray infiltrate and attendant tachypnea, hypoxia, wheezing, or changes in ventilator airway pressures.

Most patients undergoing general endotracheal anesthesia are in the supine or horizontal position. However, evidence from the literature demonstrates that the supine position in mechanically ventilated patients is a risk for aspiration and ventilator associated pneumonia (VAP). During intensive care unit (ICU) mechanical ventilation, the Institute for Healthcare Improvement recommends elevating the head of the bed to prevent pulmonary aspiration and VAP. Other investigations have shown a profound relationship between horizontal positioning and intra-operative aspiration. There is substantial operating room, ICU, and animal investigative evidence that aspiration occurs despite the presence of a cuffed endotracheal tube. Likewise, previous work by this group showed a 30% perioperative hypoxemia rate, which was significantly associated with horizontal positioning. The post-operative length of hospital stay was 2 days longer with hypoxemia, compared to no hypoxemia (p \<0.0001) and this represented a total of 300 additional days for the 2 months of the study.

The purpose of this retrospective study is to repeat the investigation after adopting a recent policy change of 10-degree Reverse Trendelenburg position as the routine for surgical patients, unless deemed inappropriate by either the anesthesiology or operating room nursing staff.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing endotracheal intubation and general anesthesia
* Age ≥18 years
* Glasgow Coma Scale score ≥13 (prior to tracheal intubation)
* American Society of Anesthesiologists classification I-IV
* Pre-operative pulmonary stability

Exclusion Criteria:

* Tracheal intubation prior to emergency department arrival
* Cardiac and thoracic surgical patients