cyrilzakka/clinical-trials huggingface dataset:
Differences in Nutrient Use During Exercise Between Children of Varying Body Mass Indices and Fitness Levels

Children who have previously participated in the study "MI Energy" will be invited to participate in "SUPER kids". Investigators want to better understand differences in nutrient use (e.g., fatty acid and carbohydrate) during rest and exercise in children of varying body types and activity levels.

We will examine fatty acid oxidation (FAO) and carbohydrate (CHO) oxidation at rest and during exercise in children of all body types and activity levels.

Children 8-11 years old who have done the "MI Energy" study will participate. Up to 80 children will be recruited to participate in this study at Arkansas Children's Nutrition Center (ACNC).

They will be asked to attend three study visits (baseline, and two exercise visits). For the exercise visits, they will follow a diet plan and be encouraged to avoid certain foods and activities.

Children will do two testing days with the following measures:

* Urine (pee) will be collected
* Body weight and height
* Exercise test on the bike - children will ride a stationary bike at a set intensity and at an intensity relative to their previous bike test during the study "MI Energy". The order in which they bike will be random. Before and during biking, children will wear a mask that will measure the gases in their breath and a monitor that will measure heart rate.

Eligibility Criteria:
Inclusion Criteria:

* Boys or girls
* Ages 8-11 years
* All races
* All ethnicities
* All BMIs
* Children who completed a dual-energy x-ray absorptiometry (DXA) scan during "MI Energy" (IRB Protocol: 260376)
* Children who completed a fitness test during "MI Energy" (IRB Protocol: 260376) and achieved peak oxygen uptake (VO2 peak)
* All fitness levels \[VO2 peak already determined under "MI Energy" (IRB Protocol: 260376)\]
* Children whose parents consented to the following in the "MI Energy" (IRB Protocol: 260376) study:

A) be contacted about future follow-up studies to "MI Energy", and having the data that is collected about their child in "MI Energy" being used also in these follow-up studies; and B) information collected in the "MI Energy" study may be used in future research related to bioenergetics (for example, blood cell mitochondria function), nutrition, obesity, cardiovascular health, or development; and C) any biological samples collected in the "MI Energy" study may be used in future research related to bioenergetics (for example, blood cell mitochondria function), nutrition, obesity, cardiovascular health, or development.

Exclusion Criteria:

* Participants who have been excluded from participation in the study "MI Energy" (IRB Protocol: 260376).
* Participants whose parents report any change in medical history that may potentially affect participation and/or study outcomes as determined by PI.
* Participants whose parents report food allergies or intolerances to nuts, wheat, dairy, or eggs.
* Participants whose parents report unwillingness to follow dietary standardization.
Corifollitropin Alfa Versus Daily rFSH in the Controlled Ovarian Stimulation of Poor Responders

A randomised, crossover, multicentre, national, clinical trial comparing the efficacy of corifollitropin alfa versus daily recombinant FSH and HMG in the controlled ovarian stimulation of women with a poor ovarian response undergoing IVF treatments. The main objective of this study is comparing the number of oocytes obtained after the follicle puncture when using each of these two stimulation protocols. Only poor responders according to the Bologna criteria will be recruited for this trial. All participants will undergo two stimulation cycles to obtain and accumulate oocytes by vitrification. One of the cycles will be done with the corifollitropin alfa protocol and the other with daily rFSH and HMG, the order of application of these protocols will be randomised (crossover clinical trial) in each patient.


Eligibility Criteria:
Inclusion Criteria:

* Advanced maternal age (≥40 years)
* A previous poor ovarian response (≤3 oocytes with a conventional stimulation protocol)
* An abnormal ovarian reserve test (i.e. antral follicle count \<5-7 follicles or anti-mullerian hormone level \<0.5-1.1 ng/ml)
An Efficacy and Safety Study With Licroca Depot, a Controlled Release Product, Injected Into the Prostate

The primary objective was to evaluate efficacy of a single dose of Liproca Depot in patients with localized prostate cancer. Primary efficacy variable was the proportion of patients showing PSA nadir. 24 Caucasian men, with a mean age at inclusion of 68.4 years, with localized prostate cancer were injected once with a ready made paste including 600 mg 2-hydroxyflutamide (Liproca Depot) into the site of the prostate where the tumour was localized. The patient was monitored for prostate-specific antigen (PSA) for maximum 6 months or to progression within this time period. The primary endpoint showed interesting results with high success rate (83%), i.e. proportion of patients (Responders) that reached plasma PSA nadir.

Patients with localized prostate cancer were followed to progression or maximum 24 weeks after a single injection in one lobe of 2-8 mL ready-made paste (corresponding to 400-1600 mg 2-Hydroxyflutamid). Progression was defined as an increase in PSA by \> 25% over baseline or on-treatment nadir.Among the 24 patients the primary endpoint, plasma PSA nadir, was reached by 20 patients (Responders). Efficacy was measured primarily as PSA nadir, and secondly as time to PSA nadir and prostate volume change. Safety was monitored throughout the whole study period.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 45years
2. Histologically confirmed localized prostate cancer (T1-T2), predominantly in one side of the peripheral zone, verified by biopsy.
3. PSA value \< 20 ng/ml within 6 weeks before enrolment.
4. Gleason score ≤ 3+4 at diagnostic biopsy
5. Adequate renal function: Creatinine \< 1.5 times upper limit of normal.
6. Adequate hepatic function: ASAT, ALAT and ALP \< 1.5 times upper limit of normal.
7. Negative dipstick for bacturia.
8. Patient must have ability to cope with the study procedures and to return to scheduled visits including follow up visit.

Exclusion Criteria:

1. Previous or ongoing hormone therapy for prostate cancer.
2. Ongoing or previous therapy (within3 month) of finasteride or dutasteride.
3. Ongoing or previous invasive therapy for benign prostate hyperplasia (TURP, TUMT).
4. Symptoms or signs of acute prostatitis.
5. Symptoms or signs of ulceric proctitis
6. Severe micturation symptoms (I-PSS \>17)
7. Concomitant systemic treatment with corticosteroids, or immunomodulating agents.
8. Known immunosuppressive disease (e.g. HIV, insulin dependent diabetes).
9. Simultaneous participation in any other study involving not market authorized drugs or having participated in a study within the last 12 months prior to start of study treatment.
Experiential Avoidance in Combat Veterans With and Without Posttraumatic Stress Disorder

This study plans to examine if symptoms of PTSD affect how Veterans who have served in combat think and react to certain information, and whether or not this has an influence on suicidal thoughts.


Eligibility Criteria:
Inclusion Criteria:

1. History of combat service
2. Diagnosis of PTSD confirmed by the CAPS or
3. No current diagnosis of PTSD
4. Age 18-65

Exclusion Criteria:

1. Inability to adequately respond to questions regarding the informed consent procedure.
2. History of significant neurological disease
3. Diagnosis of Schizophrenia or other Psychosis
4. Alcohol abuse/dependence or illicit drug use in the two weeks prior to testing
5. No history of combat service
Metabolic Effects of Very Low Carbohydrate Ketogenic Diet in Subjects With Severe Obesity

The very low carbohydrates diet (VLCKD) induces liver steatosis amelioration. Lysosomal acid lipase (LAL) deficiency plays a role in fats accumulation in liver. To date, no studies have assessed LAL activity in morbid obesity. The aim of our study is to evaluate VLCKD impact on metabolic/vascular parameters and LAL activity in obese patients.

A VLCKD is administered for 25 days to 52 morbid obese patients (BMI 44.7±8.3 kg/m², age 49±12.5 years); at baseline and after diet we evaluated: BMI, glyco-lipidic pattern, abdominal ultrasonography (liver steatosis and visceral fat area) and flow-mediated dilation (FMD). In a subgroup of 20 patients we also tested lysosomal acid lipase (LAL)-activity. A group of healthy normal weight subjects (age 43±13, BMI 22.8±2.6 kg/m²) was also included in the study.


Eligibility Criteria:
Inclusion Criteria:

* BMI \> 40 Kg/m2 or \> 35 kg/m2 with comorbidities

Exclusion Criteria:

* Type-2 diabetes
* Kidney, heart or liver failure
Multi-model Image of Immunosuppressive Agents in TAO

This study aims to evaluate the efficacy of immunosuppressive agents treating Thyroid Associated Ophthalmopathy by multi-model image.

Thyroid Associated Ophthalmopathy is one of autoimmune orbital diseases characterized by enlargement of the extraocular muscles and increase in fatty or/and orbit connective tissue volume affecting the appearance and visual function of the eyes. TAO can be classified into active phase and inactive phase according to the activity score and wait-and-see or surgery are widely chosen for patients in inactive phase. A great number of patients in inactive phase becoming refractory and reoccurring.

Until now, the improvement of TAO is still be measured subjectively with low reliability and less accuracy. Multi-modal image is a new method to assess both the appearance and visual function of TAO and some of the indexes can be regarded as more apparent and stable in assessing the efficacy and prognosis of TAO.

This perspective cohort study aims to evaluate the efficacy of immunosuppressive agents in TAO by multi-model image and function assessments.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Age 18-70 years old
* Diagnosed with TAO.

Exclusion Criteria:

* Contraindications to immunosuppressive agents.
* Patients with HIV, Hepatitis B or C, Tuberculosis or other active significant infection.
* Patients with severe chronic diseases in heart, lung, kidney and liver, which make it not tolerant to immunosuppressive agents.
* Patients have contraindications of MRI(metal pacemaker, fake teeth, foreign body and other materials which will disturb the examination).
Laryngeal Mask Airway (LMA) for Surfactant Administration in Neonates

The primary objective of this research is to compare the need for intubation and mechanical ventilation in the first seven days of life for infants with respiratory distress syndrome (RDS) on nasal continuous positive airway pressure (nCPAP) who receive surfactant via a Laryngeal Mask Airway (LMA) with those who are maintained on nCPAP and do not receive surfactant.

Secondary outcomes were total number of hours on mechanical ventilation, CPAP and supplemental oxygen during the first 7 days of life and for the entire hospitalization. Other secondary outcomes were number of surfactant doses, incidence of pulmonary air leak, survival until discharge, chronic lung disease (defined as need for oxygen at 36 weeks PMA), oxygen requirement at discharge, severe intraventricular hemorrhage (Grade 3/4), and periventricular leukomalacia.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age at time of enrollment 28 0/7 to 35 6/7 weeks postmenstrual age
* Age less than or equal to 36 hours old
* On nCPAP 6 with supplemental oxygen requirement (Fi02 greater than or equal to 30%) for greater than or equal to 30 minutes (to maintain Sa02 between 88-92%)
* Chest radiograph and clinical presentation consistent with respiratory distress syndrome (tachypnea, retractions, nasal flaring, and/or grunting

Exclusion Criteria:

* Prior mechanical ventilation or surfactant administration
* Major congenital anomaly
* Abnormality of the airway
* Respiratory distress secondary to an etiology other than respiratory distress syndrome (pneumothorax, meconium aspiration syndrome, pneumonia, hypoxic-ischemic encephalopathy)
* Apgar score \< 5 at 5 minutes of age
Effect of Effect of a Medicated Topical Therapy , Petrolatum, and No Treatment on Nocturnal Cough

This study seeks to subjectively evaluate whether a single application of Vicks® VapoRub® (VVR) ointment or a control ointment (petrolatum) will be superior to no treatment for control of nocturnal cough and congestion due to upper respiratory tract infection (URI) as rated by both parents and children.


Eligibility Criteria:
Inclusion Criteria:

* Cough and congestion attributed to upper respiratory tract infection

Exclusion Criteria:

* Children with signs or symptoms of more serious or treatable disease
* Presence of itchy, watery eyes or frequent sneezing
* Tachypnea (respiratory rate \>95%ile) or labored breathing
* Symptoms for 8 or more days
* History of asthma in the past 2 years, chronic lung disease, or seizure disorder
* History of an allergic reaction to camphor, menthol, eucalyptus, petrolatum, cedarleaf oil, nutmeg oil, thymol, turpentine oil, Over-the-counter medication containing VVR components
Bispectral Index, Suppression Rate and Emergence Agitation in Spine Surgeries

Emergence agitation; generally refers to a situation that may occur after a surgical intervention or anesthesia. This situation describes the irritability and agitation of the patient during the recovery process and the period of recovery from anesthesia. Recovery agitation may occur when the patient begins to recover and is usually a short-term condition. It resolves spontaneously. However, in some cases, this agitation may be more pronounced and disturbing. This may affect the patient\&amp;#39;s condition and relaxation. Rapid recovery from anesthesia in the clinic is also a risk factor for agitation.

When the literature is examined, there are not enough studies on Bis suppression ratio and its relationship with recovery agitation is not yet known enough. For this purpose, our study aimed to question this relationship.

There are not enough studies on BIS suppression ratio, and its relationship with recovery agitation is not yet well known. For this purpose, our study aimed to question this relationship.

For this purpose, patients\&amp;#39; post-anesthesia recovery scores and perioperative BIS and BIS suppression rates will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Patients with ASA score 1,2,3
* Patients to be extubated in the postoperative operating room
* Patients without known vascular diseases will be included.

Exclusion Criteria:

* Intraoperative surgery or aesthesia complication developments
* Those who need postoperative intensive care
* Patients who are not planned to be extubated in the operating room
Effectiveness of Music Therapy on Blood Pressure and Anxiety Among Patients Undergoing Haemodialysis

Effectiveness of music therapy on blood pressure and anxiety among patients undergoing haemodialysis

Abstract Introduction:- dialysis is one of the technological innovation in medicine in which patients are being reported to face psychosocial and physiological problems such as anxiety, stress and hypertension etc. To relieve these problems, music therapy has been widely used as a non-pharmacological intervention with the aim to assess the effectiveness of music therapy on blood pressure and anxiety among haemodialysis patients.

Methods:- current study using true experimental pre-test post-test design was conducted among 60 haemodialysis patients which were randomly allocated to experimental (30) and control (30) group using simple random sampling. The data was collected through sample characteristics performa, blood pressure monitoring data sheet and beck anxiety inventory. Patients in experimental group were provided with 30 minutes of music therapy using slow and calm relaxing instrumental piano music whereas in control group only usual care was given.

Eligibility Criteria:
Inclusion Criteria:

* willing to participate in study
* alert, oriented and able to comprehend, speak and listen Hindi or English language.

Exclusion Criteria:

* altered sensorium
* hypotension
* unresponsiveness
* hearing disabilities
Comparison of Transfers of Thawed Blastocysts Versus Blastocysts Derived From Thawed Bipronuclear Oocytes

The purpose of this study is to determine if cryopreservation at the blastocyst stage followed by embryo thaw and transfer is as effective as cryopreservation of bipronuclear oocytes followed by post-thaw extended culture (PTEC), and blastocyst transfer. Effectiveness will be measured by the rate of ongoing pregnancy at 10 weeks gestation.

Subjects will be randomized to one of two study groups during their cycles of in vitro fertilization (IVF). In one group, the subjects will have all of their embryos cryopreserved at the blastocyst stage, followed by thaw and transfer in a subsequent cycle. In the other group, subjects will have all of their embryos cryopreserved at the bipronuclear oocyte stage, followed by thaw, extended culture, and transfer in a subsequent cycle.

Eligibility Criteria:
Inclusion Criteria:

1. Female patient seeking autologous in vitro fertilization (IVF) treatment.
2. Cycle day 3 serum concentration of follicle stimulating hormone (FSH) less than 10.0 IU/l.
3. Baseline total antral follicle count observed on ultrasound with at least eight antral follicles.
4. 18 to 40 years of age.
5. Ability to read and understand English.

Exclusion Criteria:

1. Embryo biopsy (a.k.a. pre-implantation genetic diagnosis (PGD)).
2. Any condition that, in the opinion of the physician or principal investigator, would place the patient at undue risk under this protocol or would otherwise make the protocol inappropriate for that subject.
3. No minors will be enrolled in this study.
Anxiety on the First Day of Chemotherapy

investigating chemotherapy anxieties

Breast cancer is the most common type of cancer in women in the world, and it is the first in cancer-related deaths in women all over the world. In the treatment of breast cancer, in addition to surgery, patients with advanced stage or high risk of recurrence receive neoadjuvant and adjuvant chemotherapy treatments. This period starts with 3 months and extends according to the treatment protocols it will receive.

Since the first diagnosis of breast cancer, it has psychological effects such as intense stress, decrease in quality of life and anxiety as well as physical effects on patients. The time spent in the "waiting room" while patients are examined and receiving treatment before chemotherapy inevitably has an effect on their anxiety.

In this study; It was aimed to investigate the effects of environmental factors in waiting rooms on patients' anxiety.

Eligibility Criteria:
Inclusion Criteria:

* to receive chemotherapy for breast cancer for the first time
* give consent for the study

Exclusion Criteria:

* not approving to participate in the study
Clinical Parameters Predicting Unsatisfactory Cervicovaginal Cytology in Conventional Smears

According the terminology of Bethesda 2001, the unsatisfactory cervical cytology can be categorized into specimen rejected, or specimen processed and examined, but unsatisfactory for evaluation of epithelial abnormality. Most of the unsatisfactory cervical cytology was due to scanty epithelial cells, which was defined by less than an estimated 8,000 to 12,000 well-visualized squamous cells for conventional smears. Follow-up of unsatisfactory smear found an increased rate of cervical preinvasive and invasive lesions. Thus, an unsatisfactory smear deserves careful follow-up and studies. Although the Bethesda system allows criteria modification in cases of hysterectomy, pelvic irradiation therapy, or chemotherapy, no studies investigated the clinical factors related to the incidence of unsatisfactory smear. Thus, the investigators designed this trial to study the clinical factors relating to unsatisfactory cervicovaginal smear.The list of patients who received Papanicolaou smear between March 2006 and August 2006 in our hospital will be obtained from the Pathological Department first. Then the investigators will review the medical records from HIS system and pathologic files of these patients. On estimation, 7,437 cases will be enrolled for analysis. Clinical parameters for analysis include: age, gravidity, parity, abortion, menopause, location of Pap smear, history of pelvic malignancy, pelvic irradiation, cervical conization, hysterectomy; at pregnancy; three months postpartum; vaginal bleeding, vaginal abnormal discharge, intrauterine device, and cervical polyp found during pelvic examinations. Patients who missed any of above data will be excluded for analysis. The investigators will use univariate and multivariate analysis for data processing and statistic analysis to find out the relationship between clinical parameters and unsatisfactory cervicovaginal Pap smears.


Eligibility Criteria:
Inclusion Criteria:

* A cohort of consecutive patients who received conventional Pap smear between March 2006 and August 2006 in Taichung Veterans General Hospital

Exclusion Criteria:

* nil
Genetic and Epidemiologic Studies of Premature Coronary Artery Disease - SCOR in Arteriosclerosis

To identify genetic mechanisms controlling apolipoprotein levels and other 'non-traditional' risk factors in families ascertained through probands with premature coronary artery disease (CAD).

BACKGROUND:

Preliminary work for this project was carried out as part of the Johns Hopkins Coronary Artery Disease study (R01-HL-34791) which provided extensive data on families ascertained through equal numbers of white male and female probands undergoing elective angiography.

DESIGN NARRATIVE:

The study, a subproject within an Arteriosclerosis SCOR, had three components. In Component 1, the group of 203 probands under study R01HL34791 was expanded with an additional 50 black patients undergoing angiography, meeting identical criteria. In Component 2, segregation analysis was carried out on lipoproteins, apolipoproteins, and selected non-traditional risk factors on families of all probands and the etiologic heterogeneity among different groups of families was tested. In Component 3, linkage was tested between putative Mendelian loci defined in Component 2 and markers in and around candidate loci involved in lipid metabolism. Preliminary results provided evidence of Mendelian control for apolipoprotein A1 and B, and the candidate loci examined included apo B, lipoprotein lipase, and the A1-CIII-A4 gene cluster. The major hypothesis was that these apolipoprotein levels and other non-traditional risk factors might be under genetic control. Genetic analysis of these risk factors was used to direct molecular studies to identify specific mutations.

The study completion date listed in this record was obtained from the "Completed Date" entered in the Query View Report System (QVR).

Eligibility Criteria:
No eligibility criteria
Chilipad for Sleep and Symptoms of PTSD

The purpose of this study is to obtain pilot data in preparation for future research designed to formally evaluate the effectiveness of the Chilipad for patients with PTSD

This is a prospective cohort, before-after trial. 20 subjects with PTSD or PTSD symptoms (per patient report) will use the Chilipad nightly for 5 weeks after completing a short battery of PROMIS questionnaires. During the 5-week study intervention, subjects will also wear an OURA ring on a finger. The OURA week measures sleep duration and quality. 5 weeks after study enrollment, patients will repeat the battery or PROMIS questionnaires and will return the Chilipad and OURA rings, both of which will be provided free of charge by the Chilipad and OURA manufacturers

Eligibility Criteria:
Inclusion Criteria:

* Patients who have seen the study PI (Remy Coeytaux, MD, PhD) for an integrative medicine consultation between September 1, 2018 and April 30, 2019 and who report having been diagnoses with PTSD or who believe they may have PTSD or PTSD-related symptoms are eligible to participate.

Exclusion Criteria:

* No exclusion criteria