cyrilzakka/clinical-trials huggingface dataset:
Determination of Maternal and Neonatal Apelinemia in Obese Women During Pregnancy

Background :

Apelin and its receptor APJ have been implicated in pathologies including cardiovascular disease, diabetes and obesity. Little is known about the function of the apelinergic system during gestation.

Objective :

The main objective of this study is to compare apelinemia in fasting normal weight and obese women at the end of pregnancy, between 35 and 41 weeks of gestation (WG).

Strategy and method:

A prospective research evaluating will be conducted to compare apelinemia in fasting normal weight and obese women at the end of pregnancy, between 35 and 41 weeks of gestation (WG).

A third group will be created to check if gestational diabetes is not a confounding factor in obesity (group of obese women with gestational diabetes).

Investigators will try to see if apelinemia is correlated to lipidic and glycemic markers.

Samples will be collected in the cord blood to compare maternal and neonatal apelinemia and to see if neonatal apelinemia is correlated to the child's weight and birth size and to the weight of the placenta.

Placenta samples will be collected and RT-qPCR will be done to analyze RNA in each group.

Two days after delivery, obese and not obese women will be fasted and plasma and colostrum will be collected. Investigators will compare apelin levels in the colostrum between these 2 groups and then investigators will try to see if apelin level is correlated in the colostrum and in maternal plasma.

Background :

Apelin and its receptor APJ have been implicated in pathologies including cardiovascular disease, diabetes and obesity.

Little is known about the function of the apelinergic system during gestation.

In a previous study, investigators evaluated in mice this system at the feto-maternal interface in insulin-resistant obese female (HF) mice. Maternal apelinemia was decreased at term and fetal apelinemia was sixfold higher than maternal level. Ex-vivo, the placenta releases high amount of apelin at E12.5 and E18.5. In HF pregnant mice at term, apelinemia as well as placental apelin and APJ mRNA levels were increased whereas placental release of apelin was drastically reduced.

Eligibility Criteria:
Inclusion Criteria:

* Obese pregnant women
* Age from 18 to 42 years old
* Singleton pregnancy between 35+0 to 41+6 weeks of pregnancy

Exclusion Criteria:

* Severe heart, liver or kidney disease
* Multiple pregnancy
* Hypertension, preeclampsia, small for gestational age
* Pre-gestational diabetes
* Bariatric surgery
* Medication other than normal pregnancy supplementations
* Tabacco or drugs consummation during pregnancy
* Provided artificial feeding
* Fetal anoxia with cord pH less than 7.0
* Genetic or chromosomal mother's and / or newborn's abnormality
* Fetal malformation
* Trusteeship or tutorship
* Refusal to participate in research
* Unable to attend the entire study
Study of Samarium Sm-153 Lexidronam Combined With Docetaxel for Patients With Prostate Cancer

The purpose of this study is to investigate the safety, tolerability and anti-tumor effects of treatment with samarium Sm-153 lexidronam in combination with docetaxel in patients with castrate metastatic prostate cancer.

The principal objective of this trial is to evaluate the safety, feasibility, and anti-tumor effects of a novel bone-targeted regimen consisting of Samarium Sm-153 lexidronam combined with docetaxel and prednisone. This present study design permits evaluation of the clinical activity of combining two distinct agents that have shown benefit for the treatment of patients with advanced androgen-independent prostate cancer and bone metastases. It enables assessment of potential synergistic interactions between a cytotoxic chemotherapy agent and a bone-targeting radioisotope agent in the setting of a bone-targeted therapy.

Eligibility Criteria:
Inclusion Criteria:

* Have histological evidence of adenocarcinoma of the prostate.
* Have progressive castrate metastatic disease.
* Castrate levels of testosterone (\<50 ng/ml). Treatment to maintain castrate levels of testosterone must be continued.
* Must have evidence of at least 3 bone metastases on bone scan.
* Patients for whom initial hormone treatment (exclusive of neoadjuvant hormone therapy) was a combined androgen blockade approach, must show progression of disease following withdrawal of the anti-androgen prior to enrollment.
* Patients undergoing prior bisphosphonate treatments are eligible.
* Patients who have received one prior treatment with 153Sm lexidronam or 89Sr are eligible provided it is at least 12 weeks from treatment with 153Sm lexidronam or 24 weeks from treatment with 89Sr.
* Life expectancy of at least 12 weeks (based on co-morbidity).
* KPS\>60.
* Lab requirements:

  * White Blood Count (WBC) ≥ 3,000/mm3;
  * Absolute Neutrophil Count (ANC) ≥ 1,500/ mm3;
  * Platelet (PLT) ≥ 100,000/mm3;
  * Hemoglobin (HGB) ≥ 10 mg/dl;
  * Bilirubin ≤ 2.0 mg/dl;
  * ALT/AST≤ 3 times the upper limit of normal;
  * Serum creatinine ≤ 2.0 mg/dl.
* Patients must sign an informed consent.

Exclusion Criteria:

* Patients with small cell carcinoma.
* Patients with predominant visceral metastases (\>3 lung or liver lesions) or symptomatic lymphadenopathy (scrotal or pedal edema).
* Patients who have received more than one course of external beam radiation therapy directed at bone lesions.
* Clinically significant cardiac disease (New York Heart Association Class III/IV).
* History of other malignancies (other than non-melanoma skin cancer), unless in complete remission or off therapy for that disease for at least five years.
* Have or are participating in a research study protocol or clinical trial protocol within 30 days of the date of the baseline visit.
Respiratory and Physical Outcomes in Different Types of Office Workers

There are no studies in the literature reporting the posture, chest mobility, dyspnea, flexibility, quality of life and physical activity levels of emergency call center employees. The aims of this observational study are; 1) to evaluate posture, chest mobility, strength, dyspnea, flexibility, musculoskeletal disorders, physical activity and quality of life in emergency call center workers and office workers, 2) to reveal the relationships between these parameters of both research groups and 3) The aim is to compare these measurement parameters in emergency call center workers and office workers.

Over time, there has been an increase in the number of office workers and the use of computers. Working in a static position for long working hours and improper working postures can lead to loss of flexibility in the muscles, decrease in thoracic mobility, pain in the musculoskeletal system and deterioration of ideal posture. Emergency call center employees work long hours, in shifts that require serious attention, where stress is intense and the circadian rhythm is disrupted. There is no study in the literature that evaluates the posture, chest mobility, dyspnea, flexibility and physical activity levels of emergency call center employees. Therefore, the aim of our study is; It is a comparative evaluation of posture, chest mobility, cough strength, dyspnea flexibility, musculoskeletal disorders, physical activity level and quality of life in emergency call center operators and desk workers.

Eligibility Criteria:
Inclusion Criteria for Emergency Call Center Workers

* Being an operator at Izmir 112 Emergency Call Center
* Being 18 years or older
* Volunteering to participate in the study
* Being able to understand and answer surveys

Inclusion Criteria for Office Workers

* Being actively working at a desk
* Being 18 years or older
* Volunteering to participate in the study
* Being able to understand and answer surveys

Exclusion Criteria:

* Have any history of acute/chronic infection, physical or mental disability/disease and/or cognitive impairment that would prevent measurement.
* Being pregnant
* Being able to exercise regularly
Transauricular Vagus Nerve Stimulation in Children

The goal of this clinical trial is to learn about brain waves during transauricular vagus nerve stimulation (taVNS) in healthy children.

The main questions it aims to answer are:

* What is the safety, tolerability, and physiological response of taVNS in children?
* Does the electroencephalogram (EEG) change during taVNS?

Participants will

* undergo a brief titration session where taVNS will be titrated to below perceptual threshold
* receive one session of 30 minutes of taVNS
* undergo clinical EEG monitoring during taVNS
* Continuous cardiorespiratory monitoring via pulse oximetry and blood pressure every 5 minutes
* Answer tolerability questions before, during and after 30 minute taVNS session


Eligibility Criteria:
Inclusion Criteria:

* Admitted for clinical EEG for spell characterization at investigator's institution

Exclusion Criteria:

* known history of brain injury
* known history of bradycardia
* congenital heart disease
* pregnant
* pacemaker or wearable defibrillator
* undergoing active cancer treatment
Straberi Microneedling For Atrophic Acne

This pilot study will expand knowledge and application needling using the Straberi microneedling device for the improvement of Atrophic Acne Scarring

This pilot study will expand the knowledge and application of needling using the Straberi microneedling device and its safety and benefits for improving the appearance of atrophic acne scarring. The pilot aims to objectively measure skin quality using the Derma Scan, photographs, and provide objective data showing improvement by way of the Goodman and Barons quantitative scar scale.

Eligibility Criteria:
Inclusion Criteria:

* Derma Scan showing aging including skin texture, wrinkles, brown spots, and pores.
* Patients willing to sign informed consent.
* Patients willing to be photographed and video documented
* Patients willing to consent to 3 months of treatment

Exclusion Criteria:

* History of eczema in the treatment area; psoriasis and any other chronic skin conditions
* History of actinic (solar) keratosis in the treatment area;
* History of hemophilia
* History of diabetes
* The presence of raised moles, warts on the targeted area.
* Collagen vascular diseases or cardiac abnormalities
* Blood clotting problems
* Active bacterial or fungal infection
* Facial melanosis
* Malignant tumors
* Immunosuppression
* Use of blood thinners or prednisone
* Corticosteroids within two weeks of the procedure
* Chronic liver disease
* Porphyria or other skin diseases.
* Patient not willing to sign informed consent.
* TCA peels in the last 5 weeks
* Subject currently has moderate to severe acne on the face.
* Microneedling within the last 6 months
* Subject has an active infection.
* Subject has a history of a bleeding disorder
* Subject has a history of keloidal tendency
* Subject has received ablative or non-ablative laser treatments in the previous 6 months.
* Subject has taken Accutane within the previous 3 months.
4D Velocity Mapping of the Heart in rTOF Patients

MRI with 4D flow permits to assess the hemodynamic parameters in a parent vessel and its branches inside the same sequence.

MRI with 4D flow permits to assess the hemodynamic parameters in a parent vessel and its branches inside the same sequence. The objective of the project is to compare the regurgitant fraction in the pulmonary artery (PA) measured using 4D MR-flow and standard 2D MR-flow in repaired Tetralogy of Fallot (rTOF) patients. The consistency of the 4D flow quantization will be assessed assuming mass conservation in the pulmonary artery tree (PA flow =LeftPA flow +RightPA flow ? ).

Eligibility Criteria:
Inclusion Criteria:

* Tetralogy of Fallot patients
* referred for clinical MRI examination
* ≥ 15 years

Exclusion Criteria:

* Anyone with a classic contraindication to MRI
* Severe obesity
* Gadolinium chelate allergy
* \< 15 years
* counter-indication to MRI examination
* vulnerable person
Efficacy of the ALL YOU NEED is LOVE Healthcare Transition Syllabus Among Pre- and Posttransplant Adolescents in Cali, Colombia

Background: To achieve optimal outcomes, adolescents with chronic or end-stage kidney disease must undergo healthcare transition (HCT) preparation from a pediatric- to an adult-focused setting. The pediatric nephrology group at the Fundación Valle del Líli in Cali, Colombia, collaborated with the University of North Carolina Chapel Hill STARx Program and Hospital Infantil de México Federico Gómez to start an HCT preparation program using their tools. The objective of this study was to evaluate the efficacy of the "ALL YOU NEED IS LOVE" syllabus (Spanish version) and its effects on HCT readiness in young patients with kidney failure, including renal transplants.

Methods: A pre-test/post-test quasi-experimental study was conducted without control group in 11- to 21-year-old consecutive patients with kidney failure followed at the Fundación Valle de Lili. Using the TRxANSITION Index, HCT readiness skills were measured before and after implementing the "ALL YOU NEED IS LOVE" syllabus, an educational curriculum delivered in three monthly 2-hour sessions. Analysis was performed using linear mixed models in R Studio software to evaluate intervention effects while accounting for participant characteristics.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 11 to 21 years along with their primary caregivers
* Either renal transplant recipients or in a renal transplant protocol
* Under follow-up by the Nephrology Service at Fundación Valle del Lili.

Exclusion Criteria:

* Patients were excluded if they did not sign the informed consent and/or assent to participate in the study.
* If they lost their care agreement with Fundación Valle del Lili due to administrative reasons related to their health insurance provider
VR in Diabetic Polyneuropathy

This study is an experimental single centre study investigating the effect of VR on overall sleep quality and number of awakenings in patients with diabetic polyneuropathy.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 70 years old
* Able to speak Dutch/French
* Continuing usual care regarding medication use 3 weeks prior and during study participation
* Diagnosis of DPN for 6 months or longer, confirmed on EMG

Exclusion Criteria:

* History of seizures/epilepsia
* Susceptibility to motion sickness or cyber-sickness, susceptibility to claustrophobia
* shift workers
Hepatitis B Virus Infection After Liver Transplantation in Children

China is a highly prevalent area of hepatitis B virus（HBV） infection, with at least 75 million hepatitis B virus carriers, and 80% of primary hepatocellular carcinoma (HCC) is associated with chronic hepatitis B virus infection. Liver transplantation is currently the preferred method for end-stage liver disease such as biliary atresia and cirrhosis in children. In recent years, children's liver transplantation has developed rapidly and the number of developments has increased significantly. If there is chronic hepatitis B virus infection in the donor liver, it may cause HBV transmission, or the patient may have a low-load occult hepatitis B virus infection, and after immunosuppressive treatment, it may lead to hepatitis B virus infection after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients with end-stage liver disease who require liver transplantation

Exclusion Criteria:

* Children without liver transplantation refer to children;
* Children who are unwilling to participate;
Placing Trust in Endoscopic Ultrasonography: Impact on Planning Conformal Radiotherapy of Cancer of the Esophagus and Rectum

The purpose of this study is to estimate the rate of patients in whom a significant change in the area to be irradiated will be observed between the assessment before and after laying the evaluation of Trustees.

The centering of radiotherapy is done with the pre-radiation scanner for tracking the implementation of target skin markers. On this scanner, it is often difficult for the radiation therapist to pinpoint the target volume. To improve the definition of the target volume, image fusion techniques with other imaging tests were developed.

To improve the pre-radiotherapy identification, setting up markers echo-endoscopy has been described without major complications. The impact on targeting radiotherapy was mainly described for the prostate.

The marking of digestive tumors was described by the establishment of Trustees, radiopaque markers in the lymph nodes, esophagus, stomach, pancreas, and bile ducts.

Eligibility Criteria:
Inclusion Criteria:

* Male or female over the age of 18
* Rectal cancer diagnosis or esophagus
* Radiotherapy indication
* Signed consent to participate
* Patient affiliated to a social security system or benefiting from such a system

Exclusion Criteria:

* Pregnant women, of child-bearing potential, or lactating women
* Patient deprived of liberty or under supervision of a guardian
* Impossibility to undergo medical examinations of the study for geographical, social or psychological reasons
* Contra-indication for procedure study (infeasible EUS)
* Contra-indication for general anesthesia
* Patient (e) with disorders of hemostasis
* Patient (e) with portal hypertension
Prevention of Leg Cramps Using Compression Stockings or Magnesium Supplements in the Age Group of 50 to 84

Leg cramps are painful sensations of tightening in the muscles of the legs, that are often associated with secondary insomnia. They are common especially at an older age. There is no evidence that any method of prevention of nocturnal leg cramps would be both safe and effective. There are no previous trials concerning cramp prevention by using compression stockings. The objective of this study is to assess in a prospective randomised controlled trial whether leg cramps can be prevented by daily use of knee-length compression stockings or magnesium supplements.

Leg cramps are painful sensations of tightening in the muscles of the legs that commonly appear during the night and are often associated with secondary insomnia. They are common especially in older age. There is no evidence that any method of prevention of nocturnal leg cramps is both safe and effective. There are no previous trials concerning cramp prevention by using compression stockings. The objective of this study is to assess in a prospective randomised controlled trial whether leg cramps can be prevented by the daily use of knee-length compression stockings or magnesium supplements.

Methods The study will be set in Finland, and 50-84-year-old volunteers will be recruited through Google Ads, the Finnish Health Library and Finnish primary health care centres. The participants must have a minimum of two episodes of leg cramps per week for the past four weeks to be included in the study. The participants (n = 225) will be allocated to three equal groups: the compression stocking arm, the magnesium supplement arm and the placebo arm. The participants will go through four weeks of follow-up without intervention, and then another four weeks of follow-up with the assigned intervention. The material for the study will be collected through electronic questionnaires.

Discussion This protocol describes a study that compares compression stockings, magnesium supplements and placebo for the prevention of leg cramps. The results of this study can significantly improve knowledge on the methods of preventing leg cramps.

Eligibility Criteria:
Inclusion Criteria:

* Minimum of two leg cramps per week in the past four weeks.
* Age from 50 to 84 years.

Exclusion Criteria:

* Peripheral artery disease (confirmed or suspected).
* Peripheral artery bypass surgery.
* Grave peripheral neuropathy or any sensory disorder.
* Allergy to the material of the compression stockings.
* Grave renal failure (GFR under 30 ml/min).
* The use of a magnesium carbonate product (e.g. Rennie® or Berocca®).
* Cardiac failure with pulmonary oedema or massive lower limb swelling.
* Lower limb soft tissue problems, including skin transplant, thinned skin, varicose ulcer, necrosis and any infection.
* Lower limb deformity or atypical shape or size that could prevent the usage of compression stockings.
* Continuous usage of compression stockings for any other reason than leg cramps.
Effectiveness of Lumbar Facet Joint Nerve Blocks

1. To demonstrate whether:

   i. Facet joint nerve blocks have therapeutic value beyond the duration of local anesthetic effect.

   ii. Adjuvant medications (Sarapin and Depo-steroids) provide additional relief of lumbar facet joint pain when used with facet joint nerve blocks.
2. To demonstrate whether or not there are clinically significant improvements in function of patients who receive lumbar facet joint nerve block with or without Sarapin and Depo-steroids (Group II) compared to patients randomized to Group I who receive only local anesthetic blocks.
3. To determine the adverse event profile in both groups.

Primary Outcome Measure(s) To demonstrate a clinically significant difference between the patients treated with adjuvants and those patients randomized to Group I in the pain status, physical, and psychological status and pain at 3, 6, 12, 18and 24 months post treatment.

Eligibility Criteria:
Inclusion Criteria:

* Positive for facet joint pain with comparative local anesthetic blocks

Candidates are over 18 years of age

Subjects with a history of chronic, function limiting low back pain of at least six months in duration Subjects who are able to give voluntary, written informed consent to participate in this investigation Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the center for all the required post-operative follow-ups The subject has not had recent surgical procedures within the last three months.

Exclusion Criteria:

* Negative or false-positive response to controlled comparative local anesthetic blocks

Narcotic use of greater than Hydrocodone 100 mg/day, Methadone 80 mg or Morphine 100 mg, or dose equivalent

Uncontrolled major Depression or uncontrolled psychiatric disorders

Uncontrolled or acute medical illnesses including coagulopathy, renal insufficiency, chronic liver dysfunction, progressive neurological deficit, urinary sphincter dysfunction, infection, increased intercranial pressure, pseudotumor cerebri, intercranial tumors, unstable angina, and severe chronic obstructive pulmonary disease.

Chronic severe conditions that could interfere with the interpretations of the outcome assessments for pain and bodily function

Women who are pregnant or lactating

Subjects who have participated in a clinical study with an investigational product within 30 days of enrollment

Patients with multiple complaints involving concomitant hip osteoarthritis, will not be amenable to study due to the overlap of pain complaints.

Inability to achieve appropriate positioning and inability to understand informed consent and protocol History of adverse reaction to local anesthetic or anti-inflammatory drugs