cyrilzakka/clinical-trials huggingface dataset:
Study Determining the Frequency of Duchenne Muscular Dystrophy and Late-onset Pompe Disease

This is a multicenter prospective non-drug screening study. The working period is 12 months. There is no research product to be followed or used in the study.

Demographic data, medical and family histories of the patients included in the study will be collected at the first admission. The following laboratory values of the patients will be collected:

* Alanine Transaminase (ALT)
* Aspartate Transaminase (AST)
* Gamma Glutamyl Transferase (GGT)
* Creatine Phosphokinase (CPK)
* In addition, physical examination information and Abdominal USG and Liver Biopsy Results, if any, will be collected. Following the above scans, enzyme analysis for late-onset Pompe disease in boys and girls and adolescents with high CPK levels and molecular genetic tests for Duchenne muscular dystrophy in boys and adolescents with high CPK levels will be performed.


Eligibility Criteria:
Inclusion Criteria:

* 3 months -18 years old boys and girls
* Serum transaminase levels (serum ALT and / or AST levels\> 1.52 upper limit of normal (ULN)) for at least 3 months
* The willingness of the patient and / or legal representative to sign the written consent form

Exclusion Criteria:

* Patients less than 3 months
* Patients with a known history of liver disease
* Patients with a known history of muscle disease
* Patients with a known history of rheumatologic disease
* Patients with clinical history or physical examination findings that support the possibility of liver disease (Jaundice, variceal bleeding, hepatomegaly, splenomegaly, ascites)
* ICU patients
* Patients with known congenital anomalies
* Patients with organ failure
* Patients with elevated serum GGT, Total Bliribun or Direct Bilirubin levels
Exoskeleton Impact on the Quality of Life on Patients With Spinal Muscular Atrophy

The purpose of this study is to evaluate the impact of the use of a pediatric exoskeleton on the quality of life of children, specifically in the psychological and care dimensions. Other objectives are to evaluate changes at the physical and functional level.


Eligibility Criteria:
Inclusion Criteria:

* Patients between 4 and 9 years old
* Patients with a confirmed diagnostic of Spinal Muscular Atrophy Type II

Exclusion Criteria:

* Weight over 40 Kg
* Hip-knee distance less than 22 cm or greater than 38cm
* Knee-ankle distance less than 21 cm or greater than 37cm
* Distance between trochanters less than 24 cm or greater than 40cm
* Joint range limit greater than 20º
Novel Tracer Methods to Evaluate Muscle Protein Metabolism in Cirrhosis

To determine the rate and mechanisms of skeletal muscle protein synthesis and breakdown in cirrhotic patients by using multiple tracers and single muscle biopsies.

The goal of this study is to identify the molecular regulatory mechanisms that result in loss of skeletal muscle in cirrhotic patients. Current strategies involve prolonged tracer infusion and multiple muscle biopsies. We will use an innovative approach to determine the rates of skeletal muscle protein synthesis and breakdown using multiple tracers administered at short intervals followed by a single muscle biopsy. These studies are likely to provide a conceptual advance in determining the cellular and molecular responses of the skeletal muscle in cirrhosis.

Eligibility Criteria:
Inclusion Criteria:

* The diagnosis of cirrhosis based on liver biopsy and/or clinical, biochemical, and imaging criteria.
* Patients with Child Pugh score from A5- to B7
* Control group: Subject in control group should have serum ALT and AST within normal range.

Exclusion Criteria for both groups (cirrhotic and control) are:

* diabetes
* cancer
* kidney failure
* pregnancy
* recent surgery (bowel resection or Gastric bypass operation)
* Advanced cardiac or pulmonary disease
* patient with thyroid disease \& Coagulopathy ( INR \>1.4 and platelet count \<80,000/ml)
Recovering From COVID-19

Following the success of pilot data trialling a virtual community-based remote monitoring model, using Bluetooth enabled pulse oximeters, which demonstrated a saving of 300 bed spaces over a three week period,9 a nationwide expansion is set to be implemented through NHS Digital. Participants who were on the virtual wards approximately 12 weeks after their admission and those referred to long-COVID outpatient clinics will be approached.

There is a particular lack of understanding as to whether post-COVID syndrome constitutes a singular disease process. It has been suggested that the post-COVID syndrome may be characterised into either an acute or chronic subtype, depending on whether symptoms extend beyond 12 weeks following initial diagnosis.7,10 However, it is not currently understood as to whether chronic post-COVID is either an extension of acute post-COVID or is a separate disease subtype that carries a distinct risk profile.

However, there remains a paucity in the literature depicting the recovery experience, risk factors for the development of post-COVID syndrome, management strategies, and qualitative experiences. This study aims to address these gaps


Eligibility Criteria:
INCLUSION CRITERIA

* Aged 18 years or over.
* Able to provide written consent.

EXCLUSION CRITERIA

* Any participants that withdraw their consent.
* Any form of psychiatric disorder or a condition that, in the opinion of the investigator, may hinder communication with the research team.
* Inability to cooperate or communicate with the research team.
The Setting and Effect Evaluation of QT in NICU

In order to create a better environment for growth and development for very low birth weight infants(VLBWIs), investigators introduce quiet time, which is an intervention method that reduces environmental noise in the ward and centralizes medical and nursing operations. By analyzing the weight gain of VLBWIs in the intervention group and the control group during hospitalization, the effect of setting a quiet time in the NICU on improving the growth and development of VLBWIs is evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Birth weight \<1500g;
* Admit within 24 hours of birth;
* The guardian signs the informed consent.

Exclusion Criteria:

* Newborn with severe congenital malformations or various chromosomal diseases, genetic metabolic diseases, severe neurological diseases;
* Newborn who do not achieve discharge or death at the end of the study period.
Web-based Delivery of Effective Treatment for Growth in Cystic Fibrosis

This study will demonstrate feasibility and collect pilot data via a pilot randomized trial of 20 participants on the effectiveness of a web-based delivery system of behavioral plus nutrition intervention for parents of children with Cystic Fibrosis (CF) ages 4 to 9 years of age that has been found to be efficacious in face to face delivery.

Optimizing nutritional status and growth improves health outcomes and survival in children with cystic fibrosis (CF). Better pulmonary function, as measured by forced expiratory rate in 1 second (FEV1), is associated with body mass index (BMI) above the 50th percentile for age and gender for children with CF1. Evidence based practice guidelines recommend that nutritional treatment for children with CF ages 2 to 20 years should aim to achieve and maintain a BMI \> 50th percentile, however across 117 CF centers in the United States 57% of girls and 56% of boys failed to meet this recommendation1. The investigators have developed a highly effective behavioral plus nutrition intervention (BE IN CHARGE) and demonstrated its efficacy when delivered face-to-face to produce weight gain and its superiority over nutrition education alone. Although endorsed by the CF Foundation as an evidence-based treatment, it is not available to most CF Centers or families due to lack of trained personnel, cost, and distance issues. With funding from the CF Foundation the investigators developed a web-based delivery system of their efficacious behavioral plus nutrition intervention for parents of children with CF ages 4 to 9 years of age. Using a Place Outcomes Award the investigators have conducted beta testing of the web-intervention and made appropriate modifications. The current study represents the next steps in refining and testing our web-based intervention. This study will demonstrate feasibility and collect pilot data on the effectiveness of the intervention in a pilot randomized trial of 20 treatment naïve participants.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Cystic Fibrosis
* Ages 4 to 9 year
* below the 50th percentile for body mass index for age and gender
* and their parents

Exclusion Criteria:

* medical condition that would affect diet or growth (e.g., type 1 diabetes mellitus)
* significant developmental delays
* a sputum culture positive for Burkholderia cepacia
* a forced expiratory volume in the first second of expiration (FEV1) of less than 40%
* receiving enteral or parenteral nutrition.
Study to Compare hFSH-HP (Fostipur) and hMG-HP(Meriofert) in Patients With Polycystic Ovary Under a IVF/ICSI Cycle.

Polycystic ovary occurs in 15-20% of the population will be submitted to TRA. Whether it is associated with other signs or symptoms (polycystic ovarian syndrome) as if presented in isolation, its therapeutic management has special connotations sometimes favoring the low response although the standard is the tendency to hyperresponsiveness.

Although there are studies comparing the combination of FSH and LH and FSH in controlled hyperstimulation of these patients, there are no previous prospective randomized studies comparing administration of urinary FSH (hFSH-HP) with a combination of FSH and HCG (HMG HP).

Therefore the aim of this study is to prove that both drugs are comparable in the treatment of these patients. The test substances are marketed in Spain (Fostipur and Meriofert, respectively) with an indication for use in these patients. In this study both medicines will be administered in a randomized way under the usual conditions in which it is used in routine clinical practice to compare the quantity of mature oocytes respect to the total oocytes obtained, as a primary outcome measure.


Eligibility Criteria:
Inclusion Criteria:

* Female age between 18 and 38 years (inclusive)
* Women with a BMI under 30 kg / m2
* Diagnosis of polycystic ovary syndrome (according to criteria of Rotterdam)
* Women who want pregnancy
* Basal basal FSH levels under or equal 10 IU / l
* Infertility justify treatment with in vitro fertilization / intracytoplasmic sperm injection
* To be included in a protocol with GnRH antagonist
* Presence of both ovaries and uterus able to support embryo implantation and pregnancy
* Absence of pregnancy before starting ovarian stimulation
* Written consent

Exclusion Criteria:

* Severe male factor not allowing an in vitro fertilization / intracytoplasmic sperm injection with ejaculated sample
* Patients with low ovarian reserve
* Important endocrine-metabolic systemic diseases affecting pituitary, thyroid, adrenals, pancreas, liver or kidney
* HIV seropositivity
* To have frozen embryos from previous cycles of assisted reproduction
* Undiagnosed vaginal haemorrhage
* Poor response in previous cycles of in vitro fertilization with standard stimulation protocols
* Pregnancy, lactation or contraindication to get pregnant
* Malformations of the sexual organs incompatible with pregnancy
* History of allergy to gonadotrophin preparations or its excipients
* Alcohol, drugs or psychotropic addiction
* Concurrent participation in another study
* Previous history of severe hyperstimulation syndrome
* Concomitant medication that may interfere with the study medication: different hormonal treatments used in the study, other thyroid hormones, antipsychotics, anxiolytics, hypnotics, sedatives, chronic treatment with inhibitors of prostaglandin
Intra-cesarean Post Placental Introducer Withdrawal IUD Insertion Technique

This is a prospective randomized controlled study that was conducted to compare between the conventional (manual) technique of post placental IUD insertion and a new technique (intra-cesarean post placental introducer withdrawal IUD insertion technique) for IUD insertion during cesarean section regarding side effects and complications.

Complete history taking and clinical examination were obtained from all cases. Lower segment cesarean section though Pfannenstiel incision was performed. Copper T380 IUDs were inserted to all participants during cesarean section after delivery of the placenta using the following techniques:

Group A (control group): (n = 420) First, the investigators Performed time out and verify that there were no contraindications to IUD placement:, Second, after package opening the investigators Removed the IUD from the introducer and trimmed IUD threads to 12 cm, Third, the investigators Grasped the IUD firmly along the stem of the device, Fourth the investigators Stabilized the uterus using the non-dominant hand or with the aid of an assistant and advanced the IUD through the hysterotomy to the fundus, Fifth, the investigators Removed hand and directed the IUD threads into the cervix and finally the investigators Closed the uterine incision, took care not to incorporate the IUD strings.

Group B (study group): (n = 420) First the investigators Performed time out and verified that there were no contraindications to IUD placement, Second, after package opening the investigators Removed IUD from the introducer and trimmed the IUD threads to 12 cm and also trimmed the introducer to 12 cm, Third, the investigators Loaded the IUD again inside the introducer (through the trimmed end) and kept the arms of the IUD unfolded, Forth, the investigators removed the shoulders of the introducer, Fifth, the investigators held the uterus and stabilized it by the non-dominant hand and guided the introducer containing the IUD strings first through the cervix then the investigators advanced the introducer with the IUD arms unfolded to the fundus and kept the IUD their by pressing on the fundus, then the investigators pushed the introducer gently through the cervix to the vagina, Finally, the investigators Closed the uterine incision, took care not to incorporate the introducer or the threads and then the investigators removed the introducer gently manually from the vagina after closure of the skin and ceiling of the wound.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women attending for elective or emergency cesarean section

Exclusion Criteria:

* upper segment cesarean scar
* cesarean for placenta previa or placenta accrete
* evident infections
* uterine anomalies
* uterine myomas
* bleeding tendency.
Physiological Effects of 38°C vs. 22°C Fluid Therapy in Critically Ill Patients

A randomized controlled clinical trial. 24 adult ICU patients will be recruited upon decision to administer fluid bolus of 500ml of crystalloid. The fluid will then be randomized to be infused at controlled room temperature or warmed to body temperature. Hemodynamic measurements will be made for 2 hours following the bolus, and laboratory values will be noted. The hypothesis is that part of the hemodynamic response will differed in response to cooling, and be larger in the cold group.

A randomized controlled clinical trial of the influence of fluid temperature on hemodynamic effects of fluids. 24 adult ICU patients meeting objective criteria of circulatory impairment (hypotension, tachycardia, lactatemia etc) will be recruited upon decision to administer fluid bolus of 500ml of crystalloid. The fluid will then be randomized to be infused at controlled room temperature of 22 degrees or warmed to body temperature at 38 degrees. All patients will be monitored with either calibrated or uncalibrated pulse contour analysis. Hemodynamic measurements (Heart rate (HR), Systolic blood pressure (SBP), Diastolic blood pressure (DBP), Mean arterial pressure (MAP), Cardiac output (CO), Cardiac index (CI), Stroke volume (SV), Stroke volume variation (SVV), Extravascular lung water (EVLW) etc) will be registered for 2 hours following the bolus, and laboratory values such as lactate, creatinine will be noted, as well as fluid balances. Confounders such as levels of vasopressors, sedation, switches in positioning och or ventilation will be registered. The hypothesis is that part of the hemodynamic response will differed in response to cooling, and be larger in the cold group.

Eligibility Criteria:
Inclusion Criteria:

* Admission to the ICU
* Age 18 years or older
* Clinical decision to administer a fluid bolus of at least 500 ml of crystalloid over 15 minutes.
* Monitoring with either an arterial line in an extremity that can be used for pulse contour analysis (Vigileo, FloTrac or equivalent system) or a central venous catheter and a femoral arterial line that can be used for pulse contour analysis calibrated by thermodilution (EV1000, PiCCO or equivalent system)
* At least one of the following criteria for fluid administration must be met:
* MAP \< 65 mmHg
* HR \>100
* Urine output \< 0,5ml/kg/h
* Lactate levels of \> 3 mmol/l
* CI \< 2.5L/min/m2
* SVV or PPV \> 12% if mechanically ventilated with tidal volumes \> 7 ml/kg
* ScvO2 or SvO2 \< 65%

Exclusion Criteria:

* Active bleeding requiring transfusion
* Haemoglobin level \<70 g/L
* Arrhythmia disturbing monitoring of cardiac output
* Patients in whom death is considered imminent (within 24 hours)
* CRRT
* Known pregnancy
* Active temperature control, either active warming or cooling
* Medical issue of pathological thermoregulation, such as malignant hyperthermia, thyroid storm, NMDA overdose, serotonin syndrome, malignant neuroleptic syndrome, or delirium.
* Planned exit from the ICU during the 2-hour monitoring period (planned surgical procedure, radiology, change of department etc.)
Examination of Nurses' Use of Broselow Tape in Non-resuscitation Pediatric Emergency Department Practices

The patient's body weight is often taken as a basis when calculating drug doses and determining equipment sizes for pediatric patients presenting to the emergency department.

The methods used to determine body weight are the family's estimated weight, formulas for estimating weight according to age, or the Broselow band used to estimate weight according to height.

Weight estimates that are incomplete compared to the child's actual body weight lead to medication errors, wrong material selection and prolongation of the procedure, resulting in increased mortality and morbidity.

This study will be carried out to create an evidence-based practice in the selection of catheters to be used during peripheral intravenous catheter insertion, urinary catheter insertion, nasogastric/orogastric catheter insertion and aspiration in children using the Broselow band in non-resuscitation applications coming to the Pediatric Emergency Department.

By using the Boselow band in non-resuscitation pediatric emergency department applications, reducing the number of attempts and errors by ensuring the correct equipment selection in the procedures applied to patients, and increasing the success of the procedure; This will be done to ensure that the decisions taken by nurses using their experience and previous knowledge are more systematic.

Eligibility Criteria:
Inclusion Criteria:

* Children weighing 3 to 36 kg and 47 to 143 cm tall
* Children aged 0-18
* Patients coming to the emergency department for non-resuscitation procedures
* Patients and their families who volunteer to participate in the research
* Patients who will have a peripheral intravenous catheter inserted
* Patients who will have a urinary catheter inserted
* Patients who will have a nasogastric/orogastric catheter inserted
* Patients who will undergo aspiration procedure

Exclusion Criteria:

* Children weighing less than 3 kg and taller than 143 cm
* Children with anomaly contractures that may prevent measurement during measurement with the Broselow tape
* Patients with central venous catheter
* Patients with peripheral intravenous catheters outside the pediatric emergency department
* Patients who have a urinary catheter inserted outside the pediatric emergency department
* Patients who have a nasogastric/orogastric catheter inserted outside the pediatric emergency department
Perfexion Registration Using CBCT

Measuring precision radiation delivery through cone-beam computed tomography (CBCT) and intra-fraction motion management (IFMM) incorporated on a GammaKnife unit via the Leksell Coordinate Frame (LCF) and relocatable mask system (RMS) immobilization devices.

: Brain metastases are reported to occur in 20% to 40% of all patients with cancer. Treatment options for brain metastases include surgical resection, particularly in lesions causing significant mass effect, whole brain radiation (WBRT) and radiosurgery (SRS). Due to concerns of neurocognitive toxicity following WBRT, there is growing use of SRS, particularly in patients with limited brain metastases and controlled extracranial disease.

Radiosurgery delivers a high dose of radiation to a defined intracranial target through precise targeting with a sharp dose fall off at the target boundaries and minimal damage to surrounding tissue. To date, precision radiation delivery has been facilitated through the Leksell Coordinate Frame (LCF), fixated to the patient's skull through 4 pins. A relocatable mask system (RMS), consisting of a patient specific head rest and mask was developed to enable minimally-invasive fractioned radiosurgery.

A cone-beam computed tomography (CBCT) image guidance and intra-fraction motion management (IFMM) system was previously developed in-house in order to measure and address setup uncertainties on Gamma Knife. The in-house prototype has been integrated into a commercially available GammaKnife device with CBCT guidance. The installation of this device will enable volumetric guidance for all patients treated in either a single or multiple session on GammaKnife Perfexion.

This study is designed to have 2 arms, A and B. Both Arm A (using the Leksell Coordinate Frame) and Arm B (using the relocatable mask) are undergoing standard of care treatment on GammaKnife Perfexion for SRS. CBCT is part of standard of care for Arm B. However, CBCT imaging is considered as part of study treatment for Arm A. Pre and post treatment images will be acquired of the patient treated on Perfexion Gamma Knife using the Leksell Coordinate Frame in order to aid in analyzing the imaging metrics of the Image Guided Perfexion unit.

Eligibility Criteria:
Inclusion Criteria:

1. At least 18 years old
2. Ability to provide informed consent
3. Any patient receiving single or multi-fraction stereotactic radiosurgery on the Perfexion Gamma Knife with image-guidance

Exclusion Criteria:

1. Age \< 18 years old.