cyrilzakka/clinical-trials huggingface dataset:
Cardiovascular and Metabolic Responses to a Mixed Meal

The purpose is to determine whether regular endurance exercise and/or body weight influence the way our nervous and vascular systems respond during the metabolism of meals.

To begin to examine this question we recruited healthy endurance-trained (high fit, HF) and normally active (average fit, AF) subjects. It is well characterized that chronic endurance training results in enhanced peripheral insulin sensitivity. Therefore, our rationale was that inclusion of two healthy subject groups, with distinct differences in insulin sensitivity, would allow us to investigate how enhanced insulin sensitivity influences insulin-mediated changes in central sympathetic outflow. Direct measurements of central sympathetic outflow to skeletal muscle (i.e., MSNA) were recorded, and a mixed meal was used as a physiological method to evoke robust and sustained increases in MSNA, which have been primarily attributed to insulin. We hypothesized that HF subjects would have a greater MSNA response, for a given plasma insulin concentration, following consumption of a mixed meal (i.e., greater central insulin sensitivity).

Eligibility Criteria:
Inclusion Criteria:

* healthy, not currently taking any medications

Exclusion Criteria:

* unhealthy, taking medications
A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-40411813 in Male and Female Elderly Patients

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (what the body does to the study medication) and pharmacodynamics (the study of the action or effects the study medication has on the body) of single- and multiple, escalating oral doses of JNJ-40411813.

This is a double-blind (neither physician nor participants knows the treatment that the participant receives), randomized (study medication is assigned by chance), placebo-controlled (an inactive substance is compared with a medication to test whether the medication has a real effect in a clinical study), single- and multiple ascending dose study. This study consists of 3 phases: screening phase, treatment phase, and follow-up phase. This study will be conducted in 2 cohorts (groups) (Cohort 1: JNJ-40411813 50 mg and Cohort 2: JNJ-40411813 100 mg) and each cohort consists of 2 periods (Period 1: single dose and Period 2: multiple doses). Approximately 36 participants will be enrolled in this study (18 participants will be enrolled in each cohort) to receive JNJ-40411813 or placebo in 2:1 ratio. If safety/tolerability and pharmacokinetic results profile is favorable for single dose of JNJ-40411813, multiple dose administration will follow. Safety will be evaluated by the assessment of adverse events, vital signs, schellong test (a test for circulatory function), 12-lead electrocardiogram, physical examination, neurological examination (to measure mental status, motor examination, reflexes, sensory, gait and cranial nerves), vertigo (giddiness) symptom, and clinical laboratory tests which will be monitored throughout the study. The total duration of study participation for a participant will be 9 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Female participants must be postmenopausal for at least 12 months
* Body mass index (BMI) between 18 and 33 kg/m2 (BMI is calculated as weight \[kilogram\] divided by square of height \[meter\])

Exclusion Criteria:

* Clinically significant abnormal values for laboratory tests and abnormal physical examination
* Significant history of or current significant unstable medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematological disease, bronchospastic respiratory disease, dyspnea (difficulty in breathing), diabetes mellitus, thyroid disease, infection
* Significant history of or current psychiatric or neurological illness
* Serology positive for hepatitis B surface antigen, hepatitis C antibodies or HIV antibodies at screening
* Positive urine screen for drugs of abuse and positive alcohol breath test at screening or administration of the study medication
* Only the use of any prescription medication that is known to be potent CYP3A4 inhibitors or inducers within 2 weeks of start of study medication
A Feasibility Study of Internet Delivered Prolonged Exposure

The primary objective with this study is to investigate the feasibility and acceptability of ten weeks of internet delivered prolonged exposure delivered through a digital platform with therapist support. The secondary objective is to investigate preliminary effects of internet delivered prolonged exposure in terms of reducing symptoms of post-traumatic stress, depression and increase quality of life.

The investigators will investigate internet delivered prolonged exposure delivered as a ten-week treatment comprising of six modules (psychoeducation/rational, in vivo exposure, imaginal exposure, common problems during exposure, hot spots and relapse prevention). The feasibility and acceptability and preliminary effects of treatment- and assessment procedures will be evaluated using a within-group design with repeated measurements and qualitative interviews. Recruitment is designed to be broadly inclusive with minimal exclusion criteria. Patients will be recruited from a psychiatric clinic specialized in PTSD in Stockholm, Sweden and by advertisements in newspapers and social media.

Eligibility Criteria:
Inclusion Criteria:

* Currently primary diagnosis PTSD according to DSM-5 diagnostic criteria for PTSD
* ≥ 18 years
* Fluent in Swedish
* Signed informed consent

Exclusion Criteria:

* PTSD is not the primary concern
* Initiation or adjustment of any psychotropic medication within the last 4 weeks prior to commencement of treatment
* Ongoing substance dependence
* Current suicide risk meriting crisis intervention
* Psychotic disorder
* Ongoing trauma-focused psychological treatment
* Ongoing trauma-related threat (e.g. living with a violent spouse)
Evaluation of Cross-linked Collagen Membrane With and Without Silk Fibroin Around Immediate Dental Implants

Comparative evaluation of cross-linked collagen membrane with and without silk fibroin around Immediate Dental Implants -Randomized controlled trial.

Periodontal disease is an inflammatory and infectious disease affecting the tooth supporting structures leading to tooth loss when left untreated.The detrimental effect of periodontitis results in soft tissue and hard tissue loss. Bone defects has often resulted from tumor resection, congenital malformation, trauma, fractures, surgery, periodontitis or around implants in dentistry, as well as from diseases, such as osteoporosis or arthritis.These deficiencies have been overcome through various treatment modalities.It is a well-established fact that the cells from the periodontal ligament have the potential for regeneration of the tooth attachment apparatus. In addition, bone grafts and membranes have been used to regenerate the lost bone.

Among the membranes, autogenous connective tissue graft remains as gold standard. Collagen is biocompatible natural polymer that has a good function to promote new tissue formation. In the proposed study, immediate implants with compromised bone support, cross-linked bovine collagen membrane will be used. It is a naturally occurring protein, having excellent biocompatibility, and hemostatic and chemotactic characteristics for gingival fibroblasts and periodontal ligaments. Further, it is resistant to tension, controllable biodegradability, is non cytotoxic, low antigenicity, and excellent anti-inflammatory characteristics. It is naturally reabsorbed by microorganisms, easy to manipulate and has a molecular structure with little variance concerning the animal from which the collagen is extracted, leading to improved immunogenicity.

Bovine collagen is selected to enhance the biological function of silk fibroin, as composite membrane for enhancement of gingival thickness. Thus, considering all these characteristics, silk fibroin is incorporated into collagen membrane for evaluation .As there is no literature assessing this composite membrane, the aim of this study Compare evaluation of Cross-linked collagen membrane with and without Silk fibroin around Immediate Dental Implants Randomized controlled trial will be undertaken.

Eligibility Criteria:
Inclusion Criteria

* Systemically healthy patients in the age group of 18 to 55years.
* Patients undergoing immediate implant placement with gingival thickness ≤ 1mm
* Stage II /Stage III and Grade B Periodontitis patients.
* Radiographic assessment using Radiovisiography (RVG) with grid.

Exclusion Criteria:

* Patients having allergies with collagen and silk products.
* Medical conditions contraindicating surgical interventions.
* Known smokers and alcoholic.
* Acute infections at the site of extraction. Ex Abscess.
* Patients who have undergone radiotherapy or chemotherapy.
Solar Powered Oxygen Delivery

Globally, approximately 2.1 million children die of pneumonia each year. Most deaths occur in resource-poor settings in Africa and Asia. Oxygen (O2) therapy is essential to support life in these patients. Large gaps remain in the case management of children presenting to African hospitals with respiratory distress, including essential supportive therapies such as supplemental oxygen. We hypothesize that a novel strategy for oxygen delivery, solar-powered oxygen, can be implemented in remote locations and will be non-inferior to standard oxygen delivery by compressed gas cylinders.

Arterial hypoxemia in pneumonia results from several mechanisms: pulmonary arterial blood flow to consolidated lung resulting in an intrapulmonary shunt, intrapulmonary oxygen consumption, and ventilation-perfusion mismatch. Hypoxemia is a risk factor for mortality in pediatric pneumonia, and was associated with a 5-fold increased risk of death in studies from Kenya and Gambia.

In one report from Nepal, the prevalence of hypoxemia (SpO2 \< 90%) in 150 children with pneumonia was 39% overall, with increasing rates of hypoxemia across strata of pneumonia severity (100% of very severe, 80% of severe and 17% of pneumonia patients). General features of respiratory distress were associated with hypoxemia in this study, including chest indrawing, lethargy, grunting, nasal flaring, cyanosis, inability to breastfeed or drink.

Few studies have reported on the use of solar powered oxygen (SPO2) delivery. One online report describes the use of a battery-powered oxygenator in the Gambia that could be adapted to use solar power (http://www.dulas.org.uk). Otherwise, our intervention is to our knowledge the first example of SPO2 delivery.

New ways to deliver oxygen for children with pneumonia in Africa could improve outcomes and save numerous lives. If this study documents the non-inferiority of SPO2 relative to standard oxygen delivery, this novel method of providing life-saving oxygen could be rolled out across centres in sub-Saharan Africa where oxygen cylinders are not widely available and electrical power is not reliable. The potential energy efficiency, low cost and ease of use make solar power an attractive avenue of investigation for use in resource-constrained settings. Proof-of-concept that the sun can be used to drive oxygen delivery could stimulate commercial interest in this technology. The SPO2 system could thus achieve rapid penetration into the most remote or rural settings in sub-Saharan Africa.

Eligibility Criteria:
Inclusion Criteria:

* Age \<13 years
* IMCI defined pneumonia, severe pneumonia or very severe disease
* Hypoxemia (SpO2\<90%) based on non-invasive pulse oximetry
* Hospital admission warranted based on clinician judgment
* Consent to blood sampling and data collection

Exclusion Criteria:

* SpO2 ≥90%
* Suspected pulmonary tuberculosis
* Outpatient management
* Denial of consent to participate in study
Cranberry Juice and Cardiovascular Disease

Previous studies have shown that consumption of a low calorie cranberry beverage imparts a favorable impact on HDL cholesterol, LDL oxidation, and cell adhesion molecules in men. However, these studies were not well controlled. Thus, it is important to confirm these effects in a blinded, placebo-controlled feeding study. The investigators goal is to verify the cardioprotective effects of cranberries by conducting a dietary intervention trial with healthy subjects in a controlled environment.


Eligibility Criteria:
Inclusion Criteria:

* 25 to 65 years of age
* BMI 20 to 38 kg/m2

Exclusion Criteria:

* history of bariatric or certain other surgeries related to weight control
* kidney disease, liver disease, certain cancers, gout, hyperthyroidism, untreated or unstable hypothyroidism, gastrointestinal disease, pancreatic disease, other metabolic diseases, or malabsorption syndromes
* Type 2 diabetes or use of glucose-lowering medication
* Have a fasting blood sugar greater than 126 mg/dL
* LDL-cholesterol less than 130 mg/dL
* fasting triglycerides greater than 300 mg/dL
* use of cholesterol-lowering medication or supplements
* use of blood pressure-lowering medication
* smoking or use of other tobacco products (within 6 months prior to the start of the study)
* unwillingness to abstain from vitamin, mineral, and herbal supplements for 2 weeks prior to the study and during the study
* use antibiotics during the study,or for 3 weeks prior to starting the study.
* history of eating disorders or other dietary patterns which are not consistent with the dietary intervention (e.g., vegetarians, very low fat diets, high protein diets)
* weight loss of \>/= 10% of your body weight within the last 12 months or plan to initiate a weight loss program during the next 10 months
* inability to eat cranberries
* inability or unwillingness to give informed consent or communicate with study staff
* self-reported history of alcohol or substance abuse within the past 12 months and/or are currently in treatment or rehabilitation program for these problems (long-term participation in Alcoholics Anonymous is not an exclusion)
* other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol
Paramedian Spinal Anaesthesia : Comparison Between Land-mark Guided Technique and Real-time Ultrasound Guided Technique.

To identify the value of using the ultrasound in applying a commonly used regional anaesthetic procedure (spinal anaesthesia) when compared with the conventional landmark guided approach, regarding the efficiency of the anaesthetic technique, incidence of associated common complications and patient's satisfaction.


Eligibility Criteria:
Inclusion Criteria:

1. ASA physical status I-II patients
2. Patient's consented approval
3. Males or Females
4. Aged 18-60 years old
5. Body mass index less than 30
6. Scheduled for orthopaedic knee surgeries

Exclusion Criteria:

1. Age less than 18, and more than 60 years
2. Body mass index more than 30
3. Patient refusal or failure to obtain consent
4. Patient in whom spinal anaesthesia is contraindicated (infection at the site of needle insertion, coagulopathy reflected by values of INR≥ 1.2 or platelets count≤ 75.000, or receiving oral anticoagulants)
5. Known sensitivity to local anaesthetics
6. Pre-existing neurological disorder or neuromuscular disease
7. Clinically obvious or known spinal deformity or previous spinal surgery
Virtual Reality at End-of-life

The purpose of this research is to determine the effect that repeated, personalized virtual reality experiences have on symptom severity, comparing self-reported symptom severity both pre and post each session, and overtime across sessions. Researchers will also determine if this intervention results in a high rating of presence in VR, and if presence is related to the magnitude of the change in symptoms.

The purpose of this research is to determine the effect that repeated, personalized virtual reality experiences have on symptom severity, comparing self-reported symptom severity both pre and post each session, and overtime across sessions. The researchers will also determine if this intervention results in a high rating of presence in VR, and if presence is related to the magnitude of the change in symptoms.

H1: Symptom severity will decrease from pre-intervention to post-intervention. H2: The change in symptom severity will be greater in session two than it was in session one.

H3: Presence score will be higher in session two than session one. To recruit 30-40 participants, the researchers will have the clinical team working to help the research team identify eligible participants from existing caseloads. Researchers will include all hospice eligible patients, this includes people who are enrolled in hospice care but also a subset of those who are enrolled in palliative care who qualify for hospice but have refused to or haven't yet transitioned to hospice care. The site serves about 670 (as of May 2023) patients a month. Therefore, it is the researcher's intent to recruit about 3 patents per month, or a total of 30-40 patients (about 5% of the monthly population) over the course of one year.

The intervention that participants will be experiencing is personalized virtual reality experiences. The content of this experience will be determined at the initial visit during which the participant will complete a preference questionnaire which identifies the location they want to "go" to. These experiences will be filmed on the insta360 One R camera by the research coordinator. Each experience will be approximately 20 minutes. To view the videos participants will wear the Oculus Quest 2 virtual reality headset.

Eligibility Criteria:
Healthy volunteers are not applicable to this study as they study focuses on pain and symptom management at end-of-life through the virtual reality experience.

Inclusion Criteria:

* Patients who are hospice care eligible as defined by the Medicare Hospice benefit and receive hospice or palliative care from Hospice and Palliative Care Buffalo.

Exclusion Criteria:

* Their Palliative Performance Score (PPS) is below 30.
* They are not cognitively intact (display symptoms of delirium or senility, or have a cognitive diagnosis such as Alzheimer's or Dementia) as measured by the Confusion Assessment Method (CAM) (Inouye et al., 1990)
* They have hearing, vision, or speech impairments that are uncorrected.
* They have current symptoms of or a history of dizziness, nausea, headaches, migraines, seizures, or motion sickness.
* They do not speak English.
* They are not 18 years old.
The Effect of Loading Dose of Magnesium Sulfate on Uterine, Umbilical, and Fetal Middle Cerebral Arteries Doppler, Biophysical Profile, CTG, Maternal Vital Signs in Women With Severe Preeclampsia

100 women with severe preeclanpsia received Magnesium sulfate 6 grams intravenous over 20 minutes as a loading dose. Resistance index \[RI\], pulsatility index \[PI\] and systolic/diastolic \[S/D\] ratio of the umbilical artery, uterine aryery and fetal middle cerebral artery before and repeated 20 minutes after intravenous administration of 6 grams of magnesium sulphate (loading dose) over 20 minutes . fetal breathing movements and fetal gross movements are counted within 20 minutes, before and after intravenous administration of 6 grams of magnesium sulphate (loading dose) over 20 minutes

100 women with severe preeclanpsia received Magnesium sulfate 6 grams intravenous over 20 minutes as a loading dose. Resistance index \[RI\], pulsatility index \[PI\] and systolic/diastolic \[S/D\] ratio of the umbilical artery, uterine aryery and fetal middle cerebral artery before and repeated 20 minutes after intravenous administration of 6 grams of magnesium sulphate (loading dose) over 20 minutes . fetal breathing movements and fetal gross movements are counted within 20 minutes, before and after intravenous administration of 6 grams of magnesium sulphate (loading dose) over 20 minutes

Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy.
* Primigravida or Multigravida.
* Pregnant females ≥ 37 weeks of gestation.
* Diagnosed as severe preeclampsia by the following criteria:

  * Sustained systolic blood pressure of ≥160 mmHg or a sustained diastolic blood pressure of ≥ 110 mmHg.
  * Proteinuria measured as +1 or more by dipstick or 24 hours urine collection with proteinuria ≥ 0.3 grams.
  * Oliguria or creatinine \> 1.1 mg%.
  * Laboratory findings characteristic of HELLP syndrome.
  * Symptoms suggestive of severe preeclampsia ; severe headache, blurring of vision, epigastric pain.

Exclusion Criteria:

* Multifetal pregnancy.
* History of epilepsy.
* Patients with diabetes.
* Patients with renal disease.
* Fetuses with congenital anomalies.
* Patients receiving anticoagulants e.g. heparin (unfractionated or low molecular weight).
* Patients with severe IUGR.
* Patients with accidental hemorrhage.
A Biomarker Study in Patients Getting Regorafenib for Metastatic Colorectal Cancer

This is an exploratory biomarker study. Patients with metastatic colorectal cancer will receive regorafenib, which is FDA approved in this setting, on day 1-21 of every consecutive 28 day cycle. Patients will be asked to undergo tumor biopsy at baseline and 2 weeks after starting regorafenib. Peripheral blood samples will be collected at baseline 2 weeks after starting regorafenib, after initiation of cycle 3, and every 4 weeks thereafter.

Tumor tissue collected at baseline and 2 weeks after starting regorafenib will be analyzed for phosphoproteins and RNA. Peripheral blood samples will be collected and banked for protein, miRNA, and mutated DNA analysis.

Eligibility Criteria:
Inclusion Criteria:

* Metastatic colorectal cancer suitable for regorafenib treatment
* Life expectancy of at least 12 weeks
* Able to understand and willing to sign written informed consent form
* Adequate bone marrow, liver, and renal function
* Glomerular filtration rate \>/= 60 according to the Modified Diet in Renal Disease abbreviated formula
* Women of childbearing potential must have a negative serum pregnancy test
* Subject able to swallow and retain oral medication

Exclusion Criteria:

* Previous assignment to treatment in this study
* Uncontrolled hypertension
* Active or clinically significant cardiac disease
* Evidence or history of Bleeding diathesis or coagulopathy
* Any hemorrhage or bleeding even Grade 3 or higher within 4 weeks prior to start of study medication
* Subjects with thrombotic, embolic, venous or arterial events
* Subjects with any previously untreated or concurrent cancer
* Pheochromocytoma
* Known history of human immunodeficiency virus infection or current chronic or active hepatitis B or C infection requiring treatment with antiviral therapy
* Ongoing infection Grade 2 or higher
* Symptomatic metastatic brain or meningeal tumors
* Presence of a non-healing wound, non-healing ulcer, or bone fracture
* Renal failure requiring dialysis
* Dehydration Grade 1 or higher
* Seizure disorder requiring medication
* Persistent proteinuria Grade 3 or higher
* Interstitial lung disease with ongoing signs and symptoms at the time of informed consent
* Pleural effusion or ascites that causes respiratory compromise
* History of organ allograft including corneal transplant
* Known or suspected allergy or hypersensitivity to the study drug
* Any malabsorption condition
* Women who are pregnancy or breast-feeding
* Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study results
* Concurrent anticancer therapy
* Concurrent use of another investigational drug or device therapy during or within 4 weeks of trial entry
* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of study medication
* Therapeutic anticoagulation with Vitamin-K antagonists or with heparins and heparinoids
* Use of any herbal remedy