cyrilzakka/clinical-trials huggingface dataset:
Changing School Start Times: Impact on Student, Family, Teacher, and Community Health

Sleep is not an optional luxury, but a fundamental biological need, essential for health and well-being. Insufficient sleep is a significant public health issue, with 69% of adolescents in America obtaining less than the minimum requirement of 8 hours of sleep per night. Early school start times has been identified as the most significant and modifiable factor that restricts sleep duration in adolescents. The American Academy of Pediatrics recommended in 2014 that all middle and high schools start no earlier than 8:30 a.m., yet few school districts have implemented this change. In fall 2017, the Cherry Creek School District, a diverse district of almost 55,000 students outside Denver, changed school start times. Although previous studies have shown increased sleep duration, decreased daytime sleepiness, and improved academics following start time changes for secondary students, there remains an urgent need to understand how this policy impacts health and well-being for all students, including youth in elementary school. Recognizing that students are part of a complex system that includes parents, school staff, and the community, this observational study will be a multi-year, broad-based evaluation that includes key stakeholders, multiple sources of quantitative data (i.e., surveys, academic records, district nursing electronic health records), contextual qualitative data (i.e., open-ended surveys and focus groups), and community-based outcomes (i.e., data on vehicle crashes and juvenile crimes). The primary hypothesis is that later school start times will have a positive impact on middle and high school students sleep and health outcomes, while earlier school start times will have a neutral impact on elementary school students sleep and health outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Students in grades 3-12 enrolled in the school district
* Parents of students in grades K-12 enrolled in the school district
* School-based teachers and staff in grades K-12 in the school district

Exclusion Criteria:

* None
Cholesterol Effects of Kori-tofu Proteins

The study is a randomized, cross-over, double-blind, controlled trial in which participants with mildly elevated levels of cholesterol will receive two 4-week interventions (e.g. kori-tofu or control), with a wash-out period of 4 weeks in between. During the intervention periods, subjects will eat 3 slices of bread per day, representing a Kori-tofu dose of 34.5 grams or a matched reference. Fasting total and LDL cholesterol will be determined at the start and end of each of the two intervention periods.

There are several types of tofu, an example of a specific type of tofu is called Kori-tofu. Kori-tofu literally means frozen tofu. The production process of Kori-tofu leads to the formation of a higher high molecular weight fraction (HMF) content of the soy proteins. Several studies describe the effects of Kofi-tofu on health. In this study the aim is to investigate the effect of repetitive consumption of Kori-tofu on blood cholesterol levels and other lipid metabolism related measures, in research subjects with mildly elevated levels of cholesterol.

The primary objective is to assess the effect of repetitive consumption of Kori-tofu on blood total and LDL cholesterol levels. The secondary objective is to assess the effect of repetitive consumption of Kori-tofu on other markers of lipid metabolism, glucose metabolism and blood pressure.

The study is a randomized, cross-over, double-blind, controlled trial in which participants will receive two 4-week interventions (e.g. kori-tofu or control), with a wash-out period of 4 weeks in between. During the intervention periods, subjects will eat 3 slices of bread per day, representing a Kori-tofu dose of 34.5 grams or a matched reference (whey protein, soy oil and maltodextrin/cellulose). Research subjects will visit our research unit before and after each intervention period for a test day. During these test days fasting blood samples will be collected and blood pressure measurements will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Age between 40-70 years;
* BMI between 18.5-35 kg/m2;
* Total cholesterol levels \>5 mmol/L or LDL \>3 mmol/L

Exclusion Criteria:

* Use of medication/supplements/food items that may influence the study results, such as cholesterol lowering medication, Becel ProActiv (judged by our research physician);
* Total cholesterol levels \>7 mmol/L;
* LDL cholesterol levels \>5 mmol/L;
* Reported slimming, medically prescribed or other extreme diets;
* Reported weight loss or weight gain of \>5 kg in the month prior to pre-study screening;
* Not willing to give up blood donation during the study;
* Current smokers;
* Alcohol intake ≥4 glasses of alcoholic beverages per day;
* Pregnant, lactating or wishing to become pregnant in the period of the study (self-reported);
* Abuse of soft and/or hard drugs;
* Food allergies or intolerances for products that we use in the study;
* Participation in another clinical trial at the same time; NL75320.081.20 CHOKO Version number: 4, April 2021 15 of 34
* Being an employee of the Food, Health \& Consumer Research group of Wageningen Food \& Biobased Research.
Fluoroscopic &Ultrasonographic Guidance of Superior Hypogastric Plexus Neurolysis in Intractable Pelvic Pain

fluoroscopic group \& includes 30 patients where SHPB will be done Fluoroscopic-guided (the posterior oblique trajectory technique.the double modality group \& includes 30 patients where SHPB will be done using our described new technique of performing the modified Mishra technique by injecting 3-5 ml of contrast media (lohexol=omnipaque) after getting the target position.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years.
* Intractable pelvic cancer pain (VAS \> 40 mm)
* Pain is refractory to pharmacotherapy (both opioids and adjuvant therapy) or opioids' side effects are not tolerated.

Exclusion criteria

* Local or systemic sepsis.
* Uncorrectable coagulopathy.
* Neuropsychiatric illness.
* History of drug abuse.
* Pregnant or lactating patients.
* Distorted local anatomy.
* Patients who are known to be allergic to the used medications.
* Cardiovascular or respiratory instability.
Success Rate of the Miniscrews in the Mandibular Buccal Shelf

Stability of the orthodontic miniscrews placed in the mandible is still considered to bare higher risk of failure compared to other intraoral locations. The aim of our study was to determine the influence of the miniscrew size on their long-term stability, occurrence of oral mucosa inflammation and pain lasting over 48 hours after implantation.


Eligibility Criteria:
Inclusion Criteria:

* generally healthy Caucasians
* mild Class III maloclussion that required an absolute anchorage for en-masse distalization in the mandible
* hypodivergent or normal angle between the maxillary and mandibular planes
* excellent oral hygiene

Exclusion Criteria:

* Hyperdivergent angle between the maxillary and mandibular planes
* unfavorable anatomical conditions - e.g. presence of a strong frenulum potentially irritating the miniscrew head during chewing and/or facial movement
The Effect of Acupressure in Hemodialysis Patients

This randomized controlled study evaluates the effect of acupressure application on fatigue, quality of life and comfort in hemodialysis patients. In our research, it is aimed to reduce fatigue, increase the quality of life and comfort level in hemodialysis patients with acupressure applied.

In the study, 60 hemodialysis patients were randomly assigned to the study and control groups. The study group (n=30) Acupressure is formulated according to the standards of the World Health Organization and in a certain order to the points of Stomach 36 (St 36), Gall Bladder 34 point (GB 34), Spleen 6 point (SP 6) and Kidney 1 point (K 1) will be applied. Consideration will be given to the appropriate pressure intensity and duration. Since the reactions of individuals will be different from each other, the stiffness and pressure will be adjusted according to the sensitivity of the individual in order not to cause tissue damage. Pressures will be applied manually by a single practitioner. Considering the anatomical area where the point is located, the most suitable thumb, index and/or middle finger will be used for application to the relevant point. Successive compressions will be applied at a frequency that does not disturb the patient, does not cause pain, and has a calming effect. Considering the studies done, a person will be given acupressure three times a week for four weeks. No intervention will be made to the control group (n=30). In order to avoid ethical problems both groups will be given an informative training on acupressure and fatigue, increase the quality of life and comfort level in hemodialysis patients at the end of the study. The primary outcome of the study is the effect of acupuncture on fatigue in hemodialysis patients. The secondary result of the study is the effect of acupuncture on quality of life and comfort level in hemodialysis patients.

The results will be collected before the acupressure and in the 4th week of the last intervention.

Eligibility Criteria:
Inclusion Criteria:

* Written and verbal consent was obtained to participate in the study,
* Can read, write, speak and understand Turkish,
* Are older than 18 years,
* Have received HD treatment for at least 6 months,
* Receiving HD treatment 3 times a week,
* Fatigue severity ≥4, using a single-item fatigue index ranging from 0 to 10 points,
* Absence of lower extremity wounds
* Any complementary therapy
* Conscious, fully oriented and cooperative and open to communication,
* No visual, hearing and perception problems,
* Any psychiatric patient

Exclusion Criteria:

* Wound or amputation of lower extremities, rheumatoid arthritis or limb fracture
* Any psychiatric disease,
* Patients with hepatitis B and hepatitis C,
* Using any of the complementary and integrated methods
* Those who receive HD treatment twice a week
Effect of Dexamethasone Combined With Ondansetron on Postoperative Nausea and Vomiting in Patients With Patient-controlled Analgesia After Video-assisted Thoracoscopic Surgery

The purpose of this study is to study the effect of dexamethasone combined with ondansetron on postoperative nausea and vomiting in patients with patient-controlled analgesia after video-assisted thoracoscopic surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing video-assisted thoracoscopic surgery
* Age 20-75
* American Society of Anesthesiologists physical status classification I or II

Exclusion Criteria:

* Antiemetic within 24 hrs
* Taking Steroids, Opioids within 1 week
* Active drug or alcohol abuse
* GI motility disorder, severe renal/ hepatic disease.
Polymorphisms in the Human Matrix Metalloproteinase Genes MMP1, MMP3, and MMP9: Genetic Risk Factors of Primary Open Angle Glaucoma?

Matrix metalloproteinases (MMPs) fulfill diverse important molecular functions and play pivotal roles in development, tissue morphogenesis, repair, aging, and inflammatory processes. MMPs are also important disease modulating factors, such as cancer, cardiovascular disease, rheumatoid arthritis or macular degeneration. Functional genetic variants have been described to fine-tune MMP activities at the gene transcriptional level and have been associated with increased genetic risk of e.g. arteriosclerosis or cancer. MMPs are also assumed to play a major role in the remodeling of the extracellular matrix (ECM) in the optic nerve head during glaucomatous optic neuropathy. MMP-1, MMP-3 and MMP-9 have been shown to be up-regulated in a variety of animal models of glaucoma. Here, we study three promoter SNPs within the genes encoding three members of the MMP family. By assessing the prevalence of genetic variants associated with either increased/decreased enzyme activity, we will (i) estimate their contribution to the genetic risk of developing primary open angle glaucoma (POAG) and (ii) investigate the potential role of MMPs in the functional pathology of POAG.


Eligibility Criteria:
Inclusion Criteria:

* Men and women older than 39 years
* Primary open angle glaucoma as evidenced from characteristic visual field loss and optic disc cupping (POAG group)
* Healthy subjects matched by age, sex and ethnicity to the POAG patients group (control group)

Exclusion Criteria:

* Exfoliation glaucoma, pigmentary glaucoma
* History of acute angle closure
Use of Platelet-Rich Plasma (PRP) and Platelet-Poor Plasma (PPP) to Prevent Infection and Delayed Wound Healing

The purpose of this study is to see if applying PRP and PPP to surgical sites and the closing incision helps prevent infection and slow wound healing.

This will be a prospective, randomized study with patients blinded to either receiving platelet-rich plasma (PRP) and platelet-poor plasma (PPP) treatment or no treatment. We hypothesize that the antimicrobial properties of PRP and barrier properties of PPP (acting like a tissue sealant) will serve to inhibit deep incisional surgical site infection and help prevent delayed wound healing within 60 days of surgery. Thus, the incidence of infection and delayed wound healing will be lower in patients receiving PRP and PPP compared to patients who do not receive PRP and PPP. However, due to clinical equipoise, we do not know for certain that PRP and PPP is truly effective. The cost of preparing PRP and PPP is substantial, and involves a blood draw that would not otherwise be done. Thus, it is important to know if this treatment is effective or not.

Eligibility Criteria:
Inclusion Criteria:

* Elective foot and ankle surgery.

Exclusion Criteria:

* Younger than 18 years, older than 80 years of age.
Effect of Mirror Therapy and Task Oriented Training for Persons With Paretic Upper Extremity

The purpose of the study is to determine the effect of a combined mirror therapy and task oriented/repetitive task training on upper extremity function of persons with hemiplegia due to cerebrovascular accident or stroke.

This case series was designed to to determine the effect of a mirror therapy and repetitive task training program on the weak arm and hand functioning due to the consequences of stroke. Mirror therapy is a type of therapy mirror reflection of the stronger arm and hand helps to promote reorganization of neurons. Studies have shown that mirror therapy is an effective adjunct to regular exercise and task-oriented therapy.

To qualify for this study, participants must meet the following criteria: 1) age 21 years or more; 2) first-time stroke with onset of at least 3 months; 3) slight movement of the weaker arm or /and hand; 3) stable physical and mental health; and 4) mentally capable and competent to make health care-related decisions and carry out a home program.

Participants were required to come to Quinnipiac University - North Haven campus to undergo mirror therapy training, in 45-60 minute sessions, twice a week for one month. They were also required to complete pre-testing before and post-testing after the mirror therapy program. In addition, they were required to carry-out a home program that includes the use of a mirror box and self-selected tasks. The home program required them to exercise and practice the use of their more affected arm and hand for at least 1-2 hours a day.

Participation was strictly voluntary. Participants were informed of the minimal risks involved as well as their options to continue or withdraw from the study upon initial consent. The study did not yield physical or mental harm to the participants.

Eligibility Criteria:
Inclusion Criteria:

* able to give consent, complete home program
* minimal arm and hand use with the paretic limb
* onset of stroke of at least 3 months

Exclusion Criteria:

* \>1 stroke episode
* significant cognitive and visual perceptual deficit
* lack of social support
The Role of Oxytocin in the Second Stage of Labor

This is a randomized controlled trial investigating the utility of oxytocin administration in the second stage of labor.

Oxytocin is widely used on Labor and Delivery units throughout the world.Laboring patients are most likely to initiate oxytocin in the first stage of labor. Among those who receive oxytocin, first stage initiation is far more common than second stage initiation. The goal of first stage administration is to increase uterine contractility and cause cervical dilation, particularly in patients who have epidural analgesia. Once complete cervical dilation has been achieved, most providers choose to continue oxytocin in the second stage of labor for the theoretic benefit of increased expulsion "power" while pushing. This practice is currently not evidence-based as the limited data thus far suggests no difference in operative deliveries with the use of oxytocin augmentation in general. The benefits and risk of oxytocin continuation in the second stage of labor is unknown. Oxytocin administration is associated with the risk of uterine tachysystole, postpartum hemorrhage,and maternal hyponatremia. These risks call for a closer look at prolonged oxytocin use past the first stage of labor. This is a randomized controlled trial investigating the utility of oxytocin administration in the second stage of labor.

Eligibility Criteria:
Inclusion Criteria:

* Nulliparous pregnant women \>/= 37 weeks gestation
* Singleton pregnancies
* Admission for induction of labor or spontaneous labor

Exclusion Criteria:

* Multiple gestations
* Multiparous patients
* Patients with major fetal anomalies
* Not on oxytocin at the time of complete cervical dilation
* Patients with fetal head visible at the perineum on diagnosis of complete cervical dilation
* Maternal medical condition that prohibits prolonged second stage
Identification of Biomarkers for Prediction of Response or Resistance Against Target Therapy in Gastric Cancer

The aim of this study is to identify biomarkers predicting response or resistance factors of a targeted therapy with trastuzumab in advanced gastric cancer.


Eligibility Criteria:
Inclusion Criteria:

* histologically proven adenocarcinoma of the stomach or gastroesophageal junction

  * stage IV
  * patient receives chemotherapy
  * signed informed consent
  * Age \> 18 years

Exclusion Criteria:

* Patient can not understand meaning and purpose of the study
* patient already received a chemotherapy treatment for advanced disease.
A Study to Assess the Absorption, Metabolism and Excretion of [14C]-ANG-3777

The purpose of this study is to assess the mass balance recovery and metabolic profiling and identification of 14C-ANG-3777 administered as a single IV dose.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy males
2. Aged 30 to 65 years inclusive at the time of signing informed consent
3. Body mass index (BMI) of 18.0 to 32.0 kg/m2 and weighing 50 to 120 kg as measured at screening
4. Must be willing and able to communicate and participate in the whole study
5. Must have regular bowel movements (ie average stool production of ≥1 and ≤3 stools per day)
6. Must provide written informed consent
7. Must agree to adhere to the contraception requirements

Exclusion Criteria:

1. Subjects who have received any IMP in a clinical research study within the 90 days prior to Day 1
2. Subjects who are, or are immediate family members of, a study site or sponsor employee
3. Evidence of current SARS-CoV-2 infection.
4. History of any drug or alcohol abuse in the past 2 years
5. Regular alcohol consumption \>21 units per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 units = 125 mL glass of wine, depending on type)
6. A confirmed positive alcohol breath test at screening or admission
7. Current smokers and those who have smoked within the last 12 months. A confirmed breath carbon monoxide reading of greater than 10 ppm at screening or admission
8. Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
Effect of ASEA on Energy Expenditure and Fat Oxidation in Humans

To test the effect of ASEA consumption on 24-hour resting energy expenditure. Hypothesis: consumption of 8-oz of ASEA water (4-oz before breakfast and 4-oz before bedtime) will significantly elevate 24-h resting energy expenditure as compared to consumption of a placebo control (salt water, same dietary intake).

The ASEA beverage is a special oral formulation produced from a pure saline solution containing 123 mg sodium and 129 mg chloride per 4 oz. serving. A proprietary electrolytic and catalytic process rearranges the salt water solution to mimic the redox signaling molecular composition of the native salt-water compounds found in and around human cells. Data obtained thus far, suggests the possibility that consumption of the ASEA beverage may increase energy expenditure and thus be beneficial for the treatment of obesity, however, this has not been assessed in human clinical studies. To this end, we will measure the effects of ASEA consumption on energy expenditure by indirect calorimetry using the indirect room calorimeter at the University of North Carolina (UNC) Nutrition Research Institute.

The primary outcome measures will be the change in 24-h energy expenditure and respiratory quotient in response to ASEA consumption. The secondary outcome variables will include changes in relevant peptide hormones, and norepinephrine/epinephrine and their relationship to changes in energy expenditure in response to consumption of ASEA.

Eligibility Criteria:
Inclusion Criteria:

* woman
* postmenopausal
* healthy
* age 50-65
* BMI 25-35 kg/m²
* exercise less than 150 minutes per week
* weight neutral for past 6 months

Exclusion Criteria:

* smoker
* exercises more than 150 minutes per week
* abuses drugs or alcohol
* vegetarian
* taking herbal supplements, attention deficit hyperactivity disorder (ADHD) medication or thyroid medication
* taking beta-blockers, steroidal anti-inflammatory medication
* taking pseudoephedrine