cyrilzakka/clinical-trials huggingface dataset:
Fish Oils and Soybean Lecithin Supplementation Modulate Immune Function in Runners

The purpose of this study was evaluate the comparative effects of FO rich in EPA (FO-EPA) and FO rich in DHA (FO-DHA) on inflammation and neutrophil properties after a prolonged and strenuous exercise. The effect of soybean lecithin on the same parameters and conditions also was evaluated.

The volunteers were not taking any medication during the study. All individuals signed an informed consent form to the study protocol. Both experimental procedure and informed consent form of this study were in accordance with Guide for the Care and Use of Humans.

All volunteers performed two half-marathons. In the first half-marathon, all participants were not supplemented. Dietary supplementation was initiated immediately after the first race. The volunteers were randomly separated into 3 groups: Soybean lecithin group; Fish oil-DHA group and Fish oil-EPA group. The volunteers ingested 3 g daily of SL or FO-DHA containing 1.5 g DHA and 0.3 g EPA or FO-EPA containing 1.6 g EPA and 0.3 g DHA (EPA:DHA = 5.4:1) during 60 days.

Experimental design:

First race - not supplemented, blood samples were collected before (Phase I) and immediately after race (Phase II).

Second race - dietary supplemented, blood samples were collected before (Phase III) and immediately after the race (Phase IV).

Results were analyzed by two-way analysis of variance (two-way ANOVA) and Tukey post-hoc test. The statistical analysis of the half-marathon effect was performed using nonparametric t tests. Results were considered statistically significant for P\<0.05.

Eligibility Criteria:
Inclusion Criteria:

Healthy recreational half-marathon runners.

Exclusion Criteria:

Auto-immune disease Inflammatory disease Cardiorespiratory disease
Dose-escalation Study of a Contrast Agent for Delineation of Urological Anatomy in Minimally Invasive Surgery

The purpose of this clinical trial is to study the safety and efficacy of an investigational imaging agent for delineation/visualization of urologic anatomy in the setting of minimally invasive surgery.


Eligibility Criteria:
Inclusion Criteria:

* Provide written informed consent prior to the initiation of study procedures
* Are \> 18 years of age
* Women consented to undergo standard of care minimally invasive pelvic surgery (traditional laparoscopy and robotic surgery)
* Women who are expected to be admitted to the hospital following surgery for at least 24 hours

Exclusion Criteria:

* Are unwilling or unable to provide informed consent.
* Are unwilling or unable to comply with the requirements of the protocol.
* History of prior urologic surgery.
* History of prior pelvic surgery.
* History of known retroperitoneal fibrosis.
* Have any of the following screening laboratory values:

  * Hemoglobin ≤ 8.0 g/dL;
  * Absolute neutrophil count (ANC) ≤ 1500/μL;
  * Platelet count ≤ 100,000/μL;
  * Serum creatinine ≥ 1.5 x the institutional upper limit of normal (IULN) creatinine;
  * Serum bilirubin ≥ 1.5 x IULN;
  * Aspartate transaminase (AST or serum glutamic oxaloacetic transaminase, SGOT) ≥ 2x IULN;• Alanine transaminase (ALT or serum glutamate pyruvate transaminase, SGPT) ≥ 2 x IULN.
* Females who are pregnant, lactating, or breastfeeding;
* Any other condition that, in the Investigator's judgment, would potentially compromise the study compliance or the ability to evaluate safety or efficacy.
Translation and Validation of a Disease-specific Questionnaire for Hirschsprung's Disease in Danish Patients

The Hirschsprung and anorectal malformation quality of life (HAQL) questionnaire is a disease-specific quality of life questionnaire with 5 different elements (3 questionnaires for patients (categories: age 8-11, 12-16, and \>17 years) and two questionnaires for parents of patients (categories: patients aged 8-11 and 12-16 years).

In the first part of this study, the questionnaires will be translated via forward-backward-translation, culturally adapted and evaluated for content validity.

In the second part of the study, the questionnaires will be validated in a cohort of all eligible Hirschsprung patients from Odense University Hospital from 1985-2014.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Hirschsprung's Disease between the years 1985-2014
* Age \> 7 years
* Good Danish comprehension
* Signed informed consent

Exclusion Criteria:

* Inability to follow the procedures of the study, e.g. due to language problems, severe psychological disorders, dementia, etc.
Obesity Guidelines for Outpatient Surgery

The investigators are concerned about anesthetizing obese children in outpatient locations in case they need prolonged stay, increased respiratory interventions, or need for post-operative narcotics. The investigators will be using a screening guideline to help us determine the higher risk child based on BMI and co-morbid conditions. The investigators will also be doing a retrospective chart review of 300 patients with BMI 95% and looking at various factors during the operative and post-operative period.


Eligibility Criteria:
Inclusion Criteria:

* Patients 95% or over BMI having outpatient surgery.
Lung Screening Study

RATIONALE: New imaging procedures such as spiral CT may improve the ability to detect lung cancer in patients who are at high risk for the disease.

PURPOSE: Randomized clinical trial to compare the effectiveness of a spiral CT scan with that of a chest x-ray in detecting lung cancer in patients who are at high risk for the disease.

OBJECTIVES: I. Compare the efficacy of screening spiral CT scan and screening chest x-ray in detecting lung cancer in current or former smokers at high risk for lung cancer.

OUTLINE: This is a randomized, multicenter study of lung cancer screening. Patients are randomized to one of two screening arms. Arm I: Patients undergo one spiral CT scan. Arm II: Patients undergo one chest x-ray. Patients and their primary care physicians are notified of test results within 3 weeks of the exam.

PROJECTED ACCRUAL: A total of 3,000 participants (1,500 per screening arm) will be accrued for this study at six screening centers (500 per center) by October 31, 2000.

Eligibility Criteria:
DISEASE CHARACTERISTICS: See General Eligibility Criteria

PATIENT CHARACTERISTICS: Age: 55 to 74 Patients with a cigarette smoking history of at least 30 pack-years Current smoker OR Smoker who has quit smoking within the past 10 years No known prior history of lung cancer

PRIOR CONCURRENT THERAPY: No concurrent therapy for any cancer except nonmelanomatous skin cancer No prior removal of any portion of the lungs No concurrent participation in other cancer screening trial, including PLCO No concurrent participation in a primary cancer prevention trial other than a smoking cessation trial
Therapeutic Plasma Exchange in the Treatment of Sepsis Associated Multi-Organ Failure [SAMOF-TPE]

The investigators prospective, randomized adult clinical trial investigates the therapeutic efficacy of early therapeutic plasma exchange as adjunct treatment to standard therapy in patients with refractory septic shock and multiple organ failure.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients are eligible for inclusion if they have sepsis with refractory shock and evidence of organ failure.

Exclusion Criteria:

* Persons who are pregnant
* Persons who are incarcerated
* Acute surgical catastrophe without potential for intervention or source control
* Cardiac arrest with unknown neurologic status, including patients being treated with therapeutic hypothermia
* Presence of severe acute brain injury or severe dementia
* Cardiogenic, neurogenic, obstructive, or post-cardiotomy shock
* Acute pancreatitis with no established source of infection
* Diabetic ketoacidosis as primary pathology

  * Note: Septic patients who develop DKA are eligible for inclusion. However, patients in whom organ dysfunction and hemodynamic instability are due primarily to volume depletion and acidosis from DKA should not be included.
* Need for mechanical circulatory support
* Prolonged acute illness with \> 24 hours of pressor needs at enrollment and/or end organ damage with further care deemed to be "futile."

  * NOTE: The time resets if a new inciting event leads to SAMOF.
  * For example, if a patient has sepsis stabilized but requires operative intervention for source control within the initial 24 hours of admission and returns to the ICU with SAMOF, the patient is again eligible for randomization for the next 24 hours.
* Bedbound state or poor baseline functional status with ECOG performance status score ≥ 3
* Underlying terminal illness/malignancy with \< 6 months life expectancy
* Advanced chronic liver disease/cirrhosis with evidence of portal hypertension
* Asplenia
* HIV with HARRT non-compliance
Can Kangarooing Small Babies on the Back of a Mother Keep Them Warm and Stable

The purpose of this study was to assess the effectiveness of Kangarooing small babies on the back of a mother

After the study was explained (risks and benefits) and written informed consent was received from participants, an individually controlled randomized crossover clinical trial was conducted to examine the effectiveness of Chest-to-Back (CB) skin-to-skin contact (SSC) compared with the standard. The trial was done in accordance with the protocol, good clinical practice, and the national regulatory and ethics guideline of Ethiopia (which is in line with the Helsinki declaration).

Eligibility Criteria:
Inclusion Criteria:

* Neonates with LBW (\<2500 grams)
* Born prematurely (\< 37 complete weeks of gestation)

Exclusion Criteria:

* less than 35 weeks of gestation on the day of enrollment to trial
* Malformations or birth disabilities
* Dependent on oxygen or IV fluid
* Any disorder that was deemed necessary for exclusion by the investigator.
Efficacy of Herbal Galactogogues in Breastfeeding Mothers

Herbal teas with galactogoge effects have been used extensively in recent years in order to increase the amount of breast milk in lactating mothers. We also investigated whether a sleep-induced herbal tea (Still-Tee; Mamsel®) was effective in regulating the sleep of these mothers. Plain water was used as placebo.

Herbal teas with galactogoge effects have been used extensively in recent years in order to increase the amount of breast milk in lactating mothers. Mothers of premature babies often have problems in breastfeeding and this study was designed to investigate if such herbal teas has any effect on the increasing of breast milk in mothers of premature babies. We also investigated whether a sleep-induced herbal tea (Still-Tee; Mamsel®) was effective in regulating the sleep of these mothers. Plain water was used as placebo.

Eligibility Criteria:
Inclusion Criteria:

* Babies with gestational age of 35-42 weeks
* Breasfed babies
* Lactating mothers
* Babies admitted to outpatient clinics of neonatology within the the first week of life

Exclusion Criteria:

* Babies with gestational age of \<35 weeks
* Not breast feeding mothers
* Babies admitted to outpatient clinics of neonatology within the the first week of life
Effect of Minocycline on Pain Caused by Nerve Damage

The purpose of this study is to determine if minocycline is effective in the treatment of neuropathic pain. The effect of minocycline will be compared to the effect of placebo and amitriptyline.

Neuropathic pain is pain caused by damage to the central or peripheral nervous system. To date, therapy consists of tricyclic antidepressants (such as amitriptyline) or anticonvulsants. However, results are disappointing. Minocycline, a FDA-approved second generation tetracycline, was efficacious in various animal models of neuropathic pain. We want to study the effect of minocycline in neuropathic pain in humans. The type of neuropathic pain we want to investigate is lumbar radicular pain since this is the most prevalent condition associated with neuropathic pain in humans.

This placebo-controlled randomized double blind trial consists of 3 arms:

1. Placebo, once daily by mouth during 14 days.
2. Amitriptyline 25mg, once daily by mouth during 14 days.
3. Minocycline 100mg, once daily by mouth during 14 days.

Patients can take rescue medication if necessary: tramadol 50mg by mouths up to 3-times daily.

Brain-derived neurotrophic factor is implicated in the generation and maintenance of neuropathic pain in different animal models of neuropathic pain. To study the role of brain-derived neurotrophic factor in neuropathic pain in humans, we will determine its concentration in serum and plasma before and after 14 days medication intake.

Eligibility Criteria:
Inclusion Criteria:

Lumbar radicular pain due to disc herniation, failed back surgery syndrome or spinal canal stenosis causing neuropathic pain

Exclusion Criteria:

1. Diabetic, alcoholic or drug induced polyneuropathies
2. Depression or psychiatric comorbidity affecting pain sensation.
3. Use of antidepressants
4. Fibromyalgia and Chronic Fatigue Syndrome
5. Pregnancy.
6. Previous spinal cord damage
7. Malignancies
8. Allergy to minocycline or amitriptyline
Comparative Study Between HOMA1-IR and HOMA2-IR in Prediction of Ovulation Outcome in Women With PCOS

122 women diagnosed with PCOS seeking fertility in the fertility clinic at kasr Alainy hospital will be subjected to Homeostatic model assessment for insulin resistance 1 was calculated for all participants through the equation \[glucose (mmol/L) × insulin (µU/L)\]/22.5 while homeostatic model assessment for insulin resistance 2 was calculated by the HOMA2 calculator. All women will be subjected to induction of ovulation using the Aromatase inhibitor Letrozole 2.5 mg tab twice daily from the 3rd day of the cycle for 5 days . Ultrasound follow up of follicular growth will be performed till dominant follicular size reaches 18-22 mm. FSH preparations will be introduced as needed.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-35 years
* duration of infertility 1-4 years
* PCOS

Exclusion Criteria:

women with other causes of infertility (tubal factor assessed by laparoscopy or hysterosalpingogram, uterine cavity abnormality assessed by ultrasound or hysteroscopy or male factor assessed by seme analysis),

* endometriosis,
* ovarian cysts,
* endocrinological abnormalities (Diabetes mellitus, hypothalamic, pituitary or thyroid disorders, or hyperprolactinemia),
* women with history of poor ovarian response or ovarian hyperstimulation
* women with chronic diseases, chromosomal, autoimmune or coagulation defects, abnormal leucocytic count or other inflammatory markers
* Women with contraindications to pregnancy.
Sun Protection Factor Assay (319/2016)

To evaluate the Sun Protection Factor efficacy on human skin.


Eligibility Criteria:
Inclusion Criteria:

* Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
* Male and female.
* Aged between 18-70 years old.
* Good health as determined from the HRL SHF (Subject History Form).
* Signed and dated Informed Consent Form.
* Signed and dated HIPAA (Health Insurance Portability and Accountability Act) form.
* An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose).

Exclusion Criteria:

* Subjects on test at any other research laboratory or clinic.
* Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
* Pre-existing dermatologic conditions which have been diagnosed by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study.
* Pre-existing other medical conditions (e.g. adult asthma, diabetes).
* Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
* Treatment with antibiotics within two weeks prior to initiation of the test.
* Chronic medication which could affect the results of the study.
* Known pregnant or nursing women.
Helicobacter Pylori 23S rRNA/gyrA Gene Mutation Detection Kit (Fluorescence PCR Fusion Curve Method)

The purpose of this study was to evaluate the detection ability of Helicobacter pylori 23S rRNA/gyrA gene mutation detection kit (fluorescent PCR fusion curve method) for Helicobacter pylori gene mutation.

After being informed about the study and potential risks, all patients giving written informed consent will undergo a 1-week screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requriment will be included in this simultaneous blind test.

Eligibility Criteria:
Inclusion Criteria:

* 1. patients with Helicobacter pylori infection who need gastroscopy; 2. patients with positive Helicobacter pylori culture in gastric mucosa 3. Helicobacter pylori negative patients

Exclusion Criteria:

* 1.Patients with insufficient fecal samples collected 2.Patients with contraindication of gastroscopic biopsy
Phaco Versus Small Incision Cataract Surgery (SICS) Health Economic Study

To compare the health economic parameter and clinical outcome of Phacoemulsification with small incision cataract surgery (SICS)


Eligibility Criteria:
Inclusion Criteria:

* Patient has senile cataract and require unilateral cataract extraction followed by implantation of an AcrySof or PMMA (polymethylmethacrylate) posterior chamber intraocular lens (IOL);
* Pupil dilation ≧7 mm after mydrisis;
* Patient undergoing cataract surgery for the first eye;
* VA prognosis ≧6/12

Exclusion Criteria:

* Patients with history of ocular pathology or diabetic retinopathy;
* Patients with traumatic, subluxated and posterior polar cataract;
* Patients had ocular surgery in the past 6 months;
* Patients with significant intra-operative complications
Moderate Alcohol Intake Among Patients With Type 2 Diabetes

Our specific aim is to explore the effect of moderate alcohol intake on parameters of glycemic index and lipid profile among patients with type 2 diabetes.

Successful long-term control of hyperglycemia decreases the risk for diabetic complications . Although a family history of diabetes is an established risk factor for type 2 diabetes, lifestyle factors also play an important role in its cause . However, physicians are poorly informed about how their patients' alcohol use affects risk for or management of diabetes. Moderate alcohol consumption has been associated with lower risk of both cardiovascular disease and type 2 diabetes, and is also linked to lower cardiovascular risk among type 2 diabetics. Potential mechanisms have focused primarily on lipid metabolism, coagulation, fibrinolysis, and insulin sensitivity. A recent systematic review of the literature to assess the effect of alcohol consumption on risk for and management and complications of diabetes mellitus suggests that moderate alcohol consumption is associated with a decreased risk for diabetes, whereas heavy alcohol consumption may be associated with an increased risk. Our aim is to assess the effect of moderate alcohol intake on glycemic control and cardiovascular disease mediators among patients with type 2 diabetes.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 40-75 yrs.
2. Alcohol abstainers (less than or equal to 1 drink/week)
3. Established diagnosis of type 2 diabetes.
4. Clinically stable, with no stroke or MI within the last 3 months and no major surgery within the last 3 months.

Exclusion Criteria:

1. Taking Insulin \>2 injections /day, or with insulin pump.
2. TGs\>500 mg/dL.
3. HbA1c \>10%
4. Serum creatinine \> 2 mg/dl
5. Liver dysfunction (above 2 fold level of ALT and/or AST enzymes)

5. Evidence of severe diabetes complications (such as proliferative retinopathy or renal disease).

6. Patients with autonomic neuropathy manifested as postural hypertension and/or hypoglycemia unawareness. 7. Using drugs that might significantly interact with moderate alcohol. List of drugs will be obtained from pharmacology expert. 8. Presence of active cancer, receiving or had received chemotherapy in last 3 years.

9. Suffering a major illness that might probably require hospitalization (upon physician's evaluation).

10. Clinically assessed as having high potential of addictive behavior as judged by a validated clinical assessment and/or personal or family history of addiction, alcoholism or alcohol abuse.

11. Severe symptoms during run-in as assessed by the physician. 12. Pregnant or lactating women. 13. Participation in another trial in which active intervention is being received.

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The Effectiveness of Foley Airway Stylet Tool on Proseal LMA Insertion

Due to its soft cuff easily folded to impede ProSeal LMA insertion, many tools are developed. The aim of the study is to investigate the efficiency of ProSeal LMA insertion guided by a soft, direct optical Foley airway stylet tool (FAST) and compared with the standard introducer-tool (I-Tool).


Eligibility Criteria:
Inclusion Criteria:

1. patients with American Society of Anesthesiologists physical status I-II
2. aged 20-65 years
3. requiring LMA Intubation under general anesthesia
4. unlimited mouth open
5. unlimited neck motion

Exclusion Criteria:

1. mouth open \< 3 cm
2. limited neck motion
3. BMI≧35 kg/m2
Benson Relaxation Technique and Stress in Pregnancy

The aim of this study is to determine the effect of the Benson Relaxation Technique applied to pregnant women on their fear of birth, anxiety and stress levels.

The aim of this study is to determine the effect of the Benson Relaxation Technique applied to pregnant women on their fear of birth, anxiety and stress levels.

Hypotheses ; H0-1: Benson relaxation technique applied to pregnant women has an effect on childbirth.

H1-1: Benson relaxation technique applied to pregnant women has no effect on childbirth.

H0-2: Benson relaxation technique applied to pregnant women has no effect on anxiety.

H1-2: Benson relaxation technique applied to pregnant women has an effect on anxiety.

H0-3: Benson relaxation technique applied to pregnant women and their partners has no effect on stress.

H1-3: Benson relaxation technique applied to pregnant women and their partners has an effect on stress The study will be conducted on two different groups. The application will be a 1-hour Benson relaxation technique applied to pregnant women in the third trimester every week for 4 weeks. Participants will be asked to do relaxation exercises twice a day, morning and evening, for 10 to 15 minutes for 1 month. A phone number that patients can call with questions will also be provided. In addition, the researcher will call the women in the intervention group every week to follow up on the relaxation process and answer questions.

After the women are evaluated in terms of eligibility criteria for the study, information about the study will be provided to the women who are eligible and written informed consent will be obtained from the women who accept. The random distribution of the women to the study groups will be carried out using the Block Randomization method. The following applications will be applied to the groups.

The researcher will contact the experimental group by phone. The application will end after 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Those who are in their 28th-38th weeks of pregnancy,
* People with mental illness,
* People who have Anxiety disorder,
* People with hearing loss;
* People who have no experience of using relaxation methods in the past,
* People who have not used herbal or medical sedatives

Exclusion Criteria:

* Those who do not want to participate in the intervention,
* Those who have a termination of pregnancy during the intervention,
* Those who have a risky pregnancy