cyrilzakka/clinical-trials huggingface dataset:
Experimental Study of Mobile Base Station Related Radio-Frequency Electromagnetic Radiation

The purpose of this study, is to investigate if low intensity electromagnetic radiation, can influence the cognitive performances and well being of healthy adolescents and adults. Furthermore, the purpose is to provide any special information about the subjects which can cause the possible reactions. Finally, the investigation will try to clarify if there is anything specific in the radiation signal that causes the effect

EMF-exposure has been related to reported symptoms of sleep-disorders, headaches, nervousness, fatigue, and concentration difficulties. This study intends to focus on these symptoms related to the UMTS control signal.

The purpose of this study is to investigate the possible annoyance from very low intensity electromagnetic radiation, as it exists from modern antenna masts supporting mobile communication. Also we try to get a better understanding of the specific parts of the signal leading to symptoms. This investigation tries to clarify the risk for both adults and adolescents, other susceptibility factors, and whether the radiation changes cognitive functions. The above mentioned complaints have been related to psychological distress and somatization, and EMF-related complaints have been reported more by individuals with higher somatization tendency. In the present study, we therefore propose to control for symptoms of somatization and personality traits thought to influence perception and reporting of symptoms.

In this study a signal level of 1 volt/meter (2.6 mW/m2) will be used. This level should correspond to the level, experienced by the general public living rather near a base station antenna. The antenna arrangement will produce an approximation to a plane wave, so that the intensity is constant (within 2 dB) over the volume occupied by the subjects. The subjects are required to sit close to a computer screen and keyboard, which will modify the distribution slightly. The climatic chamber used for the study is modified with absorbing lining to dampen reflections from the walls. The chamber is also modified to make it a screened room to prevent external RF fields, and to some extent low frequency fields, to enter the chamber. Except for cables to the keyboard and screen there will be no other electromagnetic radiators in the chamber. The four different exposure types used, are Sham exposure (no radiation from the antennas), a UMTS signal (typical base station signal, 2140 MHz), a CW (continuous wave) of 2140 MHz. and a Wideband W-CDMA signal, f=2140 MHz, modulated with a random data sequence at a chip rate of 3.8 MHz, corresponding to a pure UMTS modulation signal, without the control signals.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Subjects
* Age 15-16 or 25-40 years

Exclusion Criteria:

* Pregnant
* Subjects with current or previous cardiovascular disease
* Subjects with current or previous fractured scull
* Subjects with chronic lung disease
* Subjects with diseases, which could involve a risk for the subject or possibly influence the outcome measurements
Effect of the Administration of L-Carnitine on Body Weight in Women in Crossfit Training

The L-carnitine has demonstrated effects in the treatment of obesity mainly promoting the fat degradation during exercise.

A randomized, double-blind, placebo-controlled clinical trial will be carry out in 24 woman with body mass index ≥ 25 to 29.9 kg/m2. The patients will receive 1.5 g of L-Carnitine deluded in 250 ml of water or placebo before crossfit training, 5 times a week for 8 weeks. Before and after intervention the investigators evaluate: The body composition (body fat, lean body mass), arm muscle circumference, waist circumference, body weight and body mass index.

Eligibility Criteria:
Inclusion Criteria:

* Volunteers who practice crossfit regularly (who have 3 months prior to the beginning of the study practicing crossfit).
* Volunteers with a body mass index equal to or greater than 25 Kg/m2.
* Volunteers who do not have allergies to L-Carnitine or any of its components.
* Informed consent signed
* Women with a recommendation of nutrition two weeks prior to the start of the study.
* Body weight stable the last 3 months.

Exclusion Criteria:

* Volunteers with pathologies such as diabetes, hypertension, metabolic syndrome and allergies.
* Women with confirmed or suspected pregnancy.
* Women under lactation and/or puerperium.
* Hypersensibilility to L-Carnitine or Sucralose.
* Kown of renal, hepatic or thyroid deseased.
* Current or previous treatment diet (3 months before inclusion to the study).
* Current pharmacological treatment for loose body weight or 3 months before inclusion to the study.
Intervening in Diabetes With Healthy Eating, Activity, and Linkages To Healthcare - The I-D-HEALTH Study

The purpose of this study is to compare ways of giving advice and providing support to improve diet and physical activity in adult primary care patients with elevated body mass index and dysglycemia.

This is a randomized comparative effectiveness trial to evaluate the health and economic effects of a community-based intensive lifestyle intervention for adult primary care patients with elevated body mass index and dysglycemia (either type 2 diabetes or pre-diabetes). The study will use qualitative and quantitative methods to assess reach, effectiveness, costs, adoption, implementation, and maintenance of a clinical-community partnership to offer intensive lifestyle intervention resources to eligible adult primary care patients.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older, AND
2. Body-mass index of ≥ 24 kg/m2, AND
3. Documented Dysglycemia: Either by verification of laboratory test (Fasting Plasma Glucose 100-125 mg/dl OR 2-hour Post-challenge Plasma Glucose 140-199 mg/dl OR A1c 5.7%-10.9%) OR confirmation of Type 2 diabetes mellitus by self-report with verification

Exclusion Criteria (any of the following):

Diseases/Conditions that could limit lifespan and/or increase risk with a lifestyle intervention:

1. Significant cardiovascular disease:

   * Uncontrolled hypertension: systolic blood pressure \>180 mmHg or diastolic blood pressure \>105 mmHg
   * A1c \> 10.9%
   * Heart attack, stroke, or transient ischemic attack (TIA) in the past 6 months
   * Chest pain, dizziness, or fainting with physical exertion
2. Lung disease:

   * Chronic obstructive airways disease or asthma requiring home oxygen
3. Pregnancy
4. Any other known condition that could limit ability to become physically active or limit life span to \<5 years

Exclusions related to metabolism:

1. Use of medications known to produce hyperglycemia
2. Known disease leading to abnormal glucose metabolism, other than diabetes mellitus, including Cushing's syndrome; acromegaly; pheochromocytoma; chronic pancreatitis

Exclusion for conditions or behaviors likely to affect the conduct of the study:

1. Unable or unwilling to provide informed consent
2. Unable to communicate with the pertinent research study staff
3. Unable to read written English or Spanish
Ethnicity and Analgesic Practice in a Pediatric Emergency Department

Early and appropriate pain management in the emergency department (ED) is an important aspect of child care. Studies in the adult population revealed that ethnicity might be associated with disparities in analgesia and opioid treatment in ED patients suffering from limb fractures. The investigators aim to explore if ethnicity has an influence on analgesic practice in the pediatric ED. The objective of this study is to determine whether minority population Arab children with orthopedic injuries are less likely than Jewish children to receive oxycodone for limb fracture.

Early and appropriate pain management in the emergency department (ED) is an important aspect of child care. Studies in the adult population revealed that ethnicity might be associated with disparities in analgesia and opioid treatment in ED patients suffering from limb fractures. The investigators aim to explore if ethnicity has an influence on analgesic practice in the pediatric ED. The objective of this study is to determine whether minority population Arab children with orthopedic injuries are less likely than Jewish children to receive oxycodone for limb fracture .

Eligibility Criteria:
Inclusion Criteria:

-Any patient with a limb fracture

Exclusion Criteria:

* Multi trauma patients
* Patients with unidentified ethnicity
Adjuvant Nonavalent HPV Vaccination in Women Treated for Vulvar HSIL

Problem description:

Yearly, approximately 45000 women develop vulvar cancer worldwide. It is estimated that about 30% of all vulvar carcinomas are HPV related. As with other HPV related (pre)malignancies, the incidence has been rising over the past 20 years. The peak incidence of premalignant lesions of the vulva, also called Vulvar High Grade Squamous Intraepithelial Lesion (vHSIL), lies between 35 and 40 years of age. Multiple treatments are available, including surgery, laser vaporization, and topical imiquimod, with comparable success rate. Despite treatment, at least 30% of women will develop a recurrence within 2 years, with a much higher lifetime risk of recurrence. This results in multiple treatments with sometimes disfiguring effects and associated negative psychosocial and psychosexual impact. Woman with vulvar HSIL have a lifelong increased risk of vulvar cancer, and approximately 10% of women with (treated) vulvar HSIL will develop vulvar cancer within 10 years of first diagnosis. The risk of malignancy is significantly higher in women with recurrent disease, compared to women without recurrence.

Solution / research direction, To date, a successful strategy for reduction of recurrences of HSIL has not been established. The available positive evidence on the use of concurrent HPV vaccination in the treatment of vulvar HSIL is rising, yet insufficient to guide clinical practice. There is limited data that prophylactic HPV vaccination after treatment of vulvar HSIL reduces the chance of recurrence, therefore leading to a reduction in repeated (surgical) interventions. There are no randomised controlled studies supporting this data.

Aim The aim of current project is to determine the effectiveness of nonavalent HPV vaccination versus placebo in preventing recurrence in women treated for vulvar HSIL.

Plan of investigation This is a randomised, double blinded, placebo controlled trial in women treated for vulvar HSIL. Adult female patients, diagnosed with vulvar HSIL planned for treatment and no prior HPV vaccination will be included. Randomisation will be in a 1:1 ratio to additional nonavalent HPV vaccination versus additional placebo vaccination.

Expected outcome. Based on previous non-randomised studies, a significant reduction in recurrences, improvement of quality of life and a reduction of economic burden of the disease is expected.


Eligibility Criteria:
Inclusion criteria

* Women 18 years or older
* Vulvar High-grade Squamous Intraepithelial Lesion (vHSIL), histologically proven
* Planned for treatment (surgical, laser or imiquimod) for vHSIL

Exclusion criteria

* Prior HPV vaccination
* (Micro-) invasive carcinoma or history of HPV related genital carcinoma (cervix, anal, vulva)
* Pregnancy
* Women allergic to vaccine components
* HIV infection
* Immune compromised patients (currently on immunosuppressive medication
Effect of Prilocaine vs Bupivacaine on Hemodynamics in Spinal Anesthesia for Geriatric Patients

Data comparing prilocaine vs bupivacaine in equipotent doses in the elderly are lacking; therefore, the study will compare the effect of prilocaine vs bupivacaine on hemodynamics in spinal anesthesia for geriatric patients undergoing endoscopic urological surgeries


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 65 years old and above.
* Both genders.
* Patients scheduled to undergo endoscopic urological surgeries.
* ASA I and II class.

Exclusion Criteria:

* Patient refusal.
* Known local anesthetic (LA) allergy.
* Bleeding disorders.
* Skin lesions or infections at site of needle insertion.
* Hypertensive patients.
* Patients candidate for transurethral resection of the prostate
* ASA III and VI class
a Trial of Using SMS Reminder Among Diabetic Retinopathy Patients in Rural China

The purpose of this study is to use a randomized controlled design to determine the impact of a SMS messaging intervention on the following outcomes among persons diagnosed with diabetic retinopathy in rural China.

SMS message reminder is a system which can sent re-visit information to remind the patient about the revisit time and address. The investigators can use the SMS system to find out if it is a useful to reduce the not-attended rate of the revisit appointment among the rural diabetic retinopathy patients.

Eligibility Criteria:
Inclusion Criteria:

- all the diabetes patients who would like to join our study in 5 CREST cooperated rural hospitals.

Exclusion Criteria:

1. Both the patient and his/her caretakers don't have cellphone,or the one who has cellphone but don't know how to use the SMS function.
2. The first re-visit appointment time is outside our study period.
Observational Study of Lyzme5 Impact on Cholesterol and Body Weight in Man

This observational placebo-controlled pilot study is intended to document whether or not Lyzme5, an over-the-counter (OTC) proprietary nutritional supplement product can positively impact, (a) weight and, (b) cholesterol levels in man.

Lyzme5 is a nutritional supplement, according to the Dietary Supplement Health and Education Act (DSHEA) of 1994. It is composed of B Vitamins along with a non-essential amino acid. The individual components of this supplement are individually Generally Recognized as Safe (have GRAS status). The manufacturer's objective was to create a nutritional supplement that would have the potential to positively impact body weight, and possibly one or more lipid value (i.e., total cholesterol, LDL, triglycerides)as well, in overweight individuals who may also have minimally elevated cholesterol levels.

This observational clinical study will seek to recruit 100 volunteers in order to observe whether or not the weight-loss potential of Lyzme5, previously observed earlier in three volunteers, can be duplicated within a larger group.

The second objective is to establish whether or not Lyzme5 can positively impact cholesterol levels in man.

Eligibility Criteria:
Inclusion Criteria:

* At least 21 years of age or older;
* Able to read, understanding, and signing a consent form;
* Not pregnant or breast feeding (female only);
* Have normal bio-markers for liver and kidney function (determined by blood test);
* Being at least 15 lbs over your ideal weight as defined by the Body Mass Index \[BMI\] chart;
* Have a total cholesterol level of or in excess of 200 mg/dl (determined by blood test);
* Not using any illegal substances, including marijuana (medicinal or otherwise);
* Not using any "recreational drugs"
* Weighing less than 300 lbs

Exclusion Criteria:

* Under 21 years of age;
* Mentally impaired;
* Pregnant or breast feeding;
* A diabetic;
* Having digestion problems;
* Problems with kidneys, heart, or liver;
* Having, or have had cancer;
* Taking a prescription;
* Weight of 300 lbs or over;
* Total cholesterol under 200 mg/dl;
* Using "recreational" drugs.
Vascularised Sentinel Skin Flaps to Detect Rejection in Pancreas Transplantation

This pilot study aims to validate the use of vascularised donor-derived sentinel skin flaps for diagnosing rejection in pancreas transplantation. The aim of the study is to investigate the use of sentinel skin flaps in clinical practice and assess whether rejection occurs concordantly or discordantly between the skin flap and the transplanted abdominal organs. If successful, sentinel skin may allow improved immune surveillance and thereby facilitate earlier treatment of rejection with subsequent improvements in allograft survival and patient morbidity.


Eligibility Criteria:
Inclusion Criteria:

* Recipient of a pancreas transplant (SPK or PTA)
* Participant is willing and able to give informed consent for participation in the study
* Male or Female, aged 18 years or above

Exclusion Criteria:

* Patient does not have a patent ulna artery in either forearm
* Recipient of an enterically drained PTA
* Patient has received any investigational medical drug within 30 days of transplantation
* Patient is not willing to return to Oxford for all clinical follow-up for 12 months
* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the trial, or the participant's ability to participate in the study.
Effect of NF-кB Dependent Proinflammation on Osteogenic Differentiation of the Mesenchymal Stem Cells in Type 2 Diabetes

This study determines whether NF-кB dependent proinflammatory state found in type 2 diabetes yield to a higher RAGE activation in the mesenchymal stem cell, as well as the effects of the proinflammation on osteoblast differentiation impairment and cellular apoptosis in type 2 diabetic patients. This study will compare non-diabetic control subjects and type 2 diabetic patients with metformin monotherapy failure in the aspect of 1) serum markers for NF-кB dependent proinflammatory state and its intracellular signals, 2) osteogenic differentiation and apoptosis of the mesenchymal stem cells, and 3) serum AGE, RAGE and cellular RAGE activation.

This study aims to explore whether proinflammation in type 2 diabetes is an mechanism underlined higher RAGE activation and osteoblast differentiation defect demonstrated in the MSC of type 2 diabetes, as well as the effects of the proinflammation on cellular differentiation and apoptosis of the MSC. Type 2 diabetes was known to be in proinflammatory state due to NF-кB-dependent cytokine secretion (for example, TNF-α, IL1 and IL6), which in turn contribute to NF-кB upregulation. Because RAGE expression is partly regulated by NF-кB signal, the NF-кB upregulation in proinflammatory state observed in type 2 diabetes may entail RAGE overactivation in this population. Therefore, the proinflammatory state and its correlation to cellular NF-кB-dependent RAGE activation is noteworthy to be determined in the MSC of type 2 diabetes. Furthermore, the effect of proinflammation on differentiation potential and apoptosis of the MSC in type 2 diabetes remains to be elucidated.

Eligibility Criteria:
Inclusion Criteria:

* Patients with type 2 diabetes who has HbA1c higher than 6.5% with metformin monotherapy and age-matched non-diabetes control subjects who signed consent form to be in the study.

Exclusion Criteria:

* Patients who use thiazolidinedione, steroid, immunosuppressive medications, antiresorptive agents or anabolic therapy for osteoporosis.
* Patients with elevated serum creatinine higher than 1.4 in female and 1.5 in male.
* Patients with metastases cancer or hematologic malignancy.
Prehabilitation in Elective Colorectal Resection: A Pilot Study (Prehab)

This is a pilot study designed to evaluate a programme of rehabilitation for patients undergoing elective colorectal resection surgery.

Operations on the colon and rectum are major abdominal operations and many individuals can become severely deconditioned or weakened afterwards. For some individuals this can even mean that they can no longer completely return to their usual way of life following one of these major operations. As part of this study the investigators are attempting to identify ways to maximize patients' recovery and to maximize their overall quality of life following these major operations. It is possible that preconditioning may make a difference to patient's overall quality of life, decreased or need for hospital length of stay and decreased postoperative medical complications occasionally seen during these operations, in essence provide an overall enhancement to their surgical recovery. Physiatrists are physicians who are medical experts in maximizing a patient's overall ability to function well and live independently. Investigators are proposing patient participation in an initial pilot study in order to test the question as to whether or not participation with a physiatrist and any interventions recommended by said physician would help improve a patient's postoperative recovery.

Eligibility Criteria:
Inclusion Criteria:

* adult patient
* scheduled to undergo a colorectal resection as part of treatment for colorectal cancer.
* English speaking or have available a family member or substitute decision maker who can accompany you to all of your study visits.

Exclusion Criteria:

* geographic inaccessibility
* unwilling to provide consent
Weighted Blanket to Treat Anxiety Related to Trying New Foods the Pediatric Population

This small experimental pilot study addresses the knowledge gap related to the use of weighted blankets for children with anxiety related to food and eating.

The purpose of the study is to research if weighted blankets might help children with anxiety related to food tolerate new foods better. The parent will be asked to complete a 10-question questionnaire and make a list of the foods the child eats on three occasions (before the study begins, after a control period and after the child uses the weighted blanket). The child will be asked to use a weighted blanket for 5 to 15 minutes prior to at least 3 meals a week for one month, and the child will be asked to complete a 20-question questionnaire taking about 5-12 minutes to complete asking about how they feel on days that they use the weighted blanket and one time a week during the month that they don't use the weighted blanket. The parent will be asked to report any new foods the child tries on the days that they do use the weighted blanket. The parent will be asked to keep the weighted blanket and supervise all use of the weighted blanket for safety. This study will take approximately 2 months total.

Eligibility Criteria:
Inclusion Criteria:

1. Subject and guardian has provided informed consent in a manner approved by the IRB and is willing and able to comply with the trial procedures.
2. Subject has identified feeding challenges
3. Subject has anxiety related to food as reported by caregiver
4. Subject is between the ages of 8-12
5. Subject has good reading abilities
6. Subject weighs 30 pounds or more

Exclusion Criteria:

1. Any medical condition that, in the opinion of the investigator, would place the subject at increased risk for participation due to the inability to remove the blanket safely. Examples of diagnoses that would exclude a participant include spinal cord injury, cerebral palsy, and muscular dystrophy.
2. Concurrent participation on another research study
3. Participants outside of the ages 8-12
4. Participants refuse to use the weighted blanket
5. If the use of a weighted blanket is contraindicated for any reason
6. Participants lacking the reading ability to complete a questionnaire
7. Participants who weigh under 30 pounds per parent report and cannot use a commercially available weighted blanket as the minimum weight of a weighted blanket is 3 pounds will be excluded but this exclusion is unlikely due to the inclusion age range