cyrilzakka/clinical-trials huggingface dataset:
SUCTIONING AT BIRTH WITH BULB SYRINGE OR SUCTION CATHETER: A RANDOMIZED CONTROLLED TRIAL

This study is designed to compare two different methods of oropharyngeal suctioning (with bulb syringe or suction catheter) in newborn infants at birth.

Objective of the study: This trial aims to compare two different methods of oropharyngeal suctioning (with bulb syringe or suction catheter) in newborn infants needing suctioning at birth.

Primary outcome measure: Oxygen saturation during the first 10 minutes of life.

Study design: This is a single center, prospective, randomized clinical trial comparing two different methods of oropharyngeal suctioning (with bulb syringe or suction catheter) in newborn infants needing suctioning at birth.

Setting: The study is conducted at the St. Luke Catholic Hospital in Wolisso (Ethiopia), which is a level III hospital with around 3,600 deliveries per year.

Immediately after birth, all infants needing suctioning are randomized to receive suctioning with bulb syringe or suction catheter. All resuscitative procedures are performed following the Helping Babies Breathe algorithm. An external observer, not involved in the care of the newborn, is responsible of the positioning the probe of the pulse oximeter and the collection of the data.

We aim to enroll 60 neonates.

Eligibility Criteria:
Inclusion Criteria:

* inborn infants (and)
* need for suctioning at birth (and)
* parental consent

Exclusion Criteria:

* Major congenital malformations
* Parental refusal to participate in the study
Comparison of Two Modes of Respiratory Physiotherapy in Cardio-thoracic Surgical Patients

Two forms of pre and postoperative physiotherapy are compared in three cohorts of patients undergoing cardio-thoracic surgery: Minor thoracic surgery (biopsy), major thoracic surgery (lobectomy etc, open or VATS) and cardiac surgery

Inspiratory force calibrated training is applied in a controlled randomized trial

Eligibility Criteria:
Inclusion Criteria:

* cardiothoracic operation,
* informed consent

Exclusion Criteria:

* reduced co-operation (such as psychiatric diagnosis),
* severe neurologic disease affecting respiratory function,
* alcohol or drug abuse at hospital entry,
* tuberculosis or other contagious lung infection,
* severe respiratory insufficiency SpO2 \< 90 or blood pO2 \<8 or rep.rate \> 25/min at rest or supplementary oxygen required at home,
* cardiac pacemaker.
High-Dose Chemotherapy and Radiation Therapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Acute Leukemia in Remission

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of high-dose radiation therapy and etoposide followed by peripheral stem cell transplantation in treating patients with acute leukemia.

OBJECTIVES: I. Evaluate the efficacy of myeloablative total-body irradiation and etoposide followed by autologous peripheral blood stem cell (PBSC) transplantation in prolonging the disease-free survival of patients with acute leukemia. II. Investigate the ability of growth factor-primed PBSC to provide hematopoietic reconstitution following myeloablative therapy.

OUTLINE: Patients are treated on Regimen A, then Regimen B. Regimen A: Stem Cell Mobilization. Granulocyte Colony Stimulating Factor (Amgen), G-CSF, NSC-614629. Regimen B: Radiotherapy and Myeloablative Chemotherapy with Hematopoietic Rescue. Total-Body Irradiation, TBI (high-energy electrons used for lung boost); and Etoposide, VP-16, NSC-141540; with Peripheral Blood Stem Cells, PBSC; G-CSF.

PROJECTED ACCRUAL: Up to 45 patients will be studied over approximately 3 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Previously diagnosed acute leukemia in one of the following categories: Acute myelogenous leukemia (any subtype) in first or subsequent remission Ph+ acute lymphoblastic leukemia (ALL) in first or greater remission Ph- ALL in second or subsequent remission Cellular marrow with no morphologic evidence of residual leukemia within approximately 2 weeks of cryopreservation Negative CSF cytology required of ALL patients Allogeneic marrow transplant considered for patients under age 55 with a healthy HLA-identical family member available

PATIENT CHARACTERISTICS: Age: Over 16 to 65 Performance status: Not specified Hematopoietic: WBC greater than 3,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 2.0 mg/dl Renal: Creatinine no greater than 1.5 mg/dl OR Creatinine clearance at least 60 ml/min Cardiovascular: LVEF at least 50% by MUGA or normal on echocardiogram Pulmonary: DLCO at least 50% of predicted Other: HIV seronegative No uncontrolled infection Negative pregnancy test required of fertile women

PRIOR CONCURRENT THERAPY: See Disease Characteristics
Study of Protective Effects of Paricalcitol on Inner Layer of Vessels and Its Protective Effect on Inflammation

The study is about possible protective effects of paricalcitol (Zemplar) upon inflammation, blood pressure and kidney function. Kidney Inflammation occurs when white blood cells become abnormally stimulated and accumulate in the kidney and cause damage to the kidney. The purpose of this study is to determine if paricalcitol helps improve kidney injury, blood pressure control and kidney function in patients with chronic kidney disease. The study will last about 7 weeks and involves about 8 visits to the medical center.

We hypothesize that use of paricalcitol in patients with chronic kidney disease will lead to improvement in oxidative stress, inflammation, endothelial function and subsequently ambulatory blood pressures and glomerular filtration rate. We will pursue our hypothesis by the three specific aims:

Aim 1: To compare oxidative stress markers in patients treated with paricalcitol before and after the study. Aim 2: To measure endothelial function by flow mediated dilation in patients with chronic kidney disease before and after paricalcitol. Aim 3: To measure actigraphy guided ambulatory blood pressure and GFR in the absence of changes in anti-hypertensive medications in patients with chronic kidney disease.

The study will be double blind randomized pilot trial in 24 patients with chronic kidney disease with 1:1:1 allocation to paricalcitol 1 microgram: paricalcitol 2 microgram: Placebo.

Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic kidney disease with estimated GFR of 30 mL/minute or more.
* Patients receiving stable dose of ACE inhibitor or Angiotensin receptor blockers for at least one month.
* Patients not currently hypertensive more than 180/110 mmHg by clinic blood pressure.
* Hemoglobulin A1C\< 11%

Exclusion Criteria:

* Patients taking vitamin D analogs
* Calcium\> 10 mg/dL
* Phosphorus\>6 mg/dL
* Patients with anticipated need of dialysis in the next 6 weeks
* Patients unstable in the opinion of the investigator
* Patients who have emergent need for starting IV iron
* Patients who will be started on statins within the next 6 weeks
* Patients currently taking PDE5 inhibitors
* Patients allergic to radiocontrast, Zemplar or who can not take nitroglycerin
* Patients known to be HIV positive
* Patients who can not give informed consent
Translational Neuroscience Optimization of GlyT1 Inhibitor

This is a Phase II, randomized, double-blind, placebo-controlled, cross-over POC study of stable patients with Schizophrenia or Schizoaffective disorder. The primary objective of this study is to test the efficacy of treatment with one of two does of a glycine transporter inhibitor (GlyT1I) combined with cognitive remediation to enhavce cognitive function. Subjects will be randomized to one of two doses of the glycine transporter inhibitor (GlyT1I) and placebo twice daily in addition to their antipsychotic medication for 2 treatment periods, each lasting a minimum of 5 weeks. Treatment periods will be separated by a washout period lasting approximately 3 weeks.


Eligibility Criteria:
Inclusion Criteria:

* 1) Males or females 21 to 65 years of age (inclusive).
* 2) Diagnosis of Schizophrenia or Schizoaffective Disorder
* 3) Able to provide written informed consent.
* 4) Only CYP2D6 extensive metabolizers.

Exclusion Criteria:

* 1) No ongoing acute medical issues
* 2) Clinically significant ECG abnormality
* 3) Blood donation within eight weeks of the start of the study
* 4) Current treatment with Clozapine
Using Radiation-free Ultrasound for Screening Scoliosis Among Female School Children in Hong Kong to Reduce Unnecessary X-ray Exposure

In the scoliosis screening program of the Student Health Service (SHS), Department of Health (DH), in Hong Kong, more than 50% of screened school children prescribed with x-ray examination basing on the screening protocol did not have Cobb angle greater than the referral threshold of 20°; ie they did not need specialist referral and thus were subjected to unnecessary x-ray exposure. Our primary objective is to determine whether a new radiation-free ultrasound system could identify subjects with Cobb angle greater than the referral threshold of 20° thus avoiding unnecessary x-rays in the referral workflow. The secondary objective is to evaluate if Angle of Trunk Rotation (ATR) can further increase the accuracy of ultrasound assessment.

This study is an extension of the registered project entitled "Using Radiation-free Ultrasound for Screening Scoliosis Among School Children in Hong Kong to Reduce Unnecessary X-ray Exposure", (ClinicalTrials.gov Identifier: NCT03135665), however focusing on validity of ultrasound measurement for immature female subjects aged around ten with year since menarche equal to or less than 9 months, who are prone to curve progression, and thus are among the most critical group in clinical management of scoliosis for regular monitoring, treatment decision, and brace indication.


Eligibility Criteria:
Inclusion Criteria:

i. School children in Hong Kong attending School Screening Program provided by Student Health Service ii. Recommended for radiographic assessment in the scoliosis screening program iii. Female with year since menarche of equal to or less than 9 months

Exclusion Criteria:

i. Patients with standing height \<1 m, or \>2 m ii. Patients with body mass index (BMI) ≥25 kg/m2 iii. Subjects with skin diseases iv. Subjects with fracture or wound that affect ultrasound scanning v. Subjects with ferromagnetic implants vi. Subjects with surgery done for the spine vii. Subjects with winged scapula or other irregularity of back contour that affect ultrasound scanning viii. Subjects who cannot stand steadily during scanning ix. Subjects with allergy to ultrasound gel
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Subcutaneous Injections of HRS9531 in Patients With Type 2 Diabetes Mellitus

The main purpose of this study is to assess the safety and tolerability of multiple subcutaneous injections of HRS9531 in patients with type 2 diabetes mellitus who have suboptimal glycaemic control after conventional lifestyle or metformin intervention.


Eligibility Criteria:
Inclusion Criteria:

1. Males and infertility females, 18-65 years of age, inclusive, on the date of signing informed consent.
2. Diagnosed with type 2 diabetes mellitus (T2DM) for at least 6 months.
3. Treated with conventional lifestyle intervention alone or stable treatment with metformin (≥1000 mg/day) at least 8 weeks prior to screening.
4. 7.0% ≤ HbA1c ≤10.5% at screening.

Exclusion Criteria:

1. History or presence of vital organ primary diseases, including but not limited to neuropsychiatric, cardiovascular, digestive, respiratory, urinary, endocrine, blood, immune and other diseases, judged by researchers to be unsuitable for this study.
2. Diagnosed or suspected with type 1 diabetes mellitus, special types of diabetes or secondary diabetes.
3. Have a history of acute complications of diabetes (diabetic ketoacidosis, lactic acidosis, hyperglycaemic hyperosmolar state, etc.) or episode of severe hypoglycaemic events within 12 months prior to screening.
4. Have a presence of proliferative diabetic retinopathy, diabetic macular edema, or nonproliferative diabetic retinopathy requiring treatment during the trial;
5. Participants in clinical trials of any drug or medical device in the 3 months prior to screening.
6. Breast-feeding women.
7. The investigator considers that the subject has any other factors that would make it inappropriate to participate in this study.
Diet and the Aging Brain

We investigate whether a change in diet could provide positive effects on general brain functions in healthy elderly people.

The age-related degradation of cognitive functions even to the point of neurodegenerative disorders such as alzheimer's disease are a growing public-health concern with potentially devastating effects.

Refering to animal data and empirical studies, a healthy diet rich in unsaturated fatty acids and low in calories should improve cognitive functions such as learning and memory. To test this hypothesis, we study general brain functions in healthy elderly subjects (50-80 years old) during a short term diet.

Eligibility Criteria:
Inclusion Criteria:

* healthy subjects
* 50-80 years old
* moderate to heavy weight
* must be able to change diet at home

Exclusion Criteria:

* diabetes
* younger than 50 years
* BMI \< 23
* already participating in other studys
* MMSE \> 26
* eating disorders
The Effects of High-intensity Interval Training on Mental Health and Inflammation

The present study investigated the effects of high-intensity interval exercise training and placebo-exercise on mental health and inflammation using a randomized control trial. The study also examined how anxiety symptoms prior to high-intensity interval training may influence improvements in fitness. Inactive young adults underwent nine weeks of either high-intensity interval training or their regular routine. Questionnaires, a blood draw and a maximal exercise test were conducted the week before and week after the intervention. It was hypothesized those who underwent high-intensity interval training would experience greater reductions in their depression, anxiety, and inflammation than those who were in the placebo control group. It was also hypothesized those who had high anxiety symptoms at the start of high-intensity interval training would experience smaller improvements in fitness than those who had low anxiety symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Full-time student at McMaster University
* Speak, read and understand English

Exclusion Criteria:

* Exercising for more than 150 minutes of moderate-to-vigorous physical activity per week
Predicting Osteoarthritis Risk Following Knee Injury.

This observational study seeks to identify and validate novel soluble biomarkers (within blood, synovial fluid, urine) which contribute to the prognostic assessment of an individual with an acute knee injury, a group of individuals in which \~50% will progress to symptomatic radiographic knee osteoarthritis (OA).

150 individuals will be followed over 5 years with clinical assessment including validated questionnaires, biological sampling and radiological imaging (X ray, magnetic resonance imaging (MRI)).


Eligibility Criteria:
Inclusion Criteria:

* Clinically significant acute knee injury within 8 weeks of recruitment
* Aged 16-50
* Knee effusion, evident clinically or by MRI
* Evidence on MRI of structural injury (from list of relevant injuries)
* Informed written consent

Exclusion Criteria:

* Knee injured more than 8 weeks prior to recruitment
* Pre-existing advanced radiographic OA (Kellgren Lawrence (KL) grade 3-4) of same side knee at baseline
* Known history of inflammatory/septic arthritis of same side knee
* Knee replacement - previous or planned within 2 years of study start
* Active other (treated) inflammatory disease or infection
* Positive pregnancy test
* Not consenting, or contraindication to provide blood samples:

  * Bilateral mastectomy
  * Bilateral fistulae for renal dialysis
* Unable to give informed written consent in English
Peripheral Reading

The purpose of this study is to evaluate reading performance in the visual periphery by simulating central vision loss using a computer-controlled gaze-contingent display with an eye tracker. Participants will read a page of text at a comfortable rate. Several manipulations hypothesized to improve reading will be tested, such as an inverted-text "spotlight" of a single word that follows the participant's gaze.

Participants will view paragraphs of multiple sentences of text with their central vision blocked computationally with a "simulated scotoma." Participants will be free to move their eyes around the page of text at a comfortable rate. The three outcomes described elsewhere will be evaluated.

In different blocks, text will contain one or more of several dynamic assistive manipulations that are hypothesized to enhance reading: 1) inverting the text at a given position, with instructions for the participant to attend to that location, which simulates a "surrogate fovea" of a patient with central vision loss. 2) horizontally expanding text to alleviate within-word crowding. 3) highlighting the next word with a visible indicator to encourage proper eye movements.

Eligibility Criteria:
Inclusion Criteria:

* Normal vision
* English language

Exclusion Criteria:

* Less than 20/20 vision in either eye
* Abnormalities which affect vision (amblyopia, keratoconus, etc.)
* Ortho-K lenses
Moray Micro Forceps and Pancreatic Cyst

The prevalence of pancreatic cysts in the general population is high close to 1%. The diagnosis is most of the time fortuitous thanks to the improvement of the imaging resources available. These lesions include a large number of entities, some of with malignant potential. Mucinous lesions present a high risk of tumor transformation, justifying surgery, which is sometimes heavy. It appears essential to select the best patients to benefit from this type of treatment. For this purpose, the accuracy of the diagnostic means must be optimal. The Fine Needle Aspiration under Endoscopic ultrasound, validated in this context, have a low complication rate. It allows a cytological evaluation and analysis of tumor markers measurements in cystic fluid. However, cytopathological evaluation is only contributing in 1/3 to half of cases. The assays of markers (including the main one ACE) have high specificities but high insufficient sensitivities (less than 50%). Molecular techniques (K-RAS mutation in particular), of variable availability, allow to increase the sensitivity in association with the other diagnostic parameters. But the rate of false negatives remains above 20% to date. A diagnostic means to obtain a histology of the cyst wall would reduce considerably the risk of error.

The Moray™ micro forceps is forceps that aims to provide a tissue sample of the wall of the pancreatic cyst. It is inserted into a commonly used 19 Gauge needle during the puncture of the cyst under endoscopic ultrasound. It could increase the accuracy diagnosis of the procedure. These forceps has recently become available to the practitioner and has obtained the CE marking.

To date, no quality multi-center prospective evaluation has determined the capacity of to obtain a histology of the pancreatic cystic walls by this technique. Its safety must be also be accurately assessed.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years old
* FNA of the cystic fluid indicated during an endoscopic ultrasound examination
* Abdominal CT and pancreatic MRI less than 3 months old, available
* Pancreatic cyst unilocular or with a macrolocule in case of multilocular cyst, of size ≥ to 20 mm of major axis with a clean wall.

Exclusion Criteria:

* Contraindication to performing an upper endoscopic ultrasound
* Patient with known chronic calcifying pancreatitis, or suspected on the iconography available during the screening visit
* Patient taking an antiplatelet, or anticoagulant therapy including anti-vitamin K, direct oral anticoagulant, or heparin.
* Hemorrhagic disease, hemostasis and coagulation disorder (TP \< 60%, TCA \> 40 sec. and platelets \< 60000/mm3), malignant hematopathy, chronic cirrhotic liver disease with Child Pugh B or C, acute or severe chronic renal failure (creatinine clearance \< to 30 ml/min)
* Mental disability of the subject making participation in the trial impossible
* Patient not affiliated to a social security system
* Inability to understand or sign informed consent
* Serious adverse events
* Early termination of participation, withdrawal of voluntary informed consent of the patient
* Violation of protocol
Fenofibrate in Combination with Ursodeoxycholic Acid in Primary Biliary Cholangitis

The main objectives of the study were to assess the effects of fenofibrate on serum alkaline phosphatase, as a composite endpoint and on safety in participants with primary biliary cholangitis (PBC)


Eligibility Criteria:
Inclusion Criteria:

* Must have provided written informed consent
* Age 18-75 years;
* BMI 17-28 kg/m2
* Male or female with a diagnosis of PBC, by at least two of the following criteria:

  1. History of alkaline phosphatase（ALP） above upper limit of normal（ULN） for at least six months;
  2. Positive Anti-mitochondrial antibody (AMA) titers (\>1/40 on immunofluorescence or M2 positive by enzyme linked immunosorbent assay (ELISA) or positive PBC-specific antinuclear antibodies;
  3. Documented liver biopsy result consistent with PBC.
* Incomplete response to UDCA defined by 1 x ULN\< ALP \<= 1.67 x ULN
* Taking UDCA for at least 6 months (stable dose for ≥ 3 months) prior to Day 0

Exclusion Criteria:

* History or presence of other concomitant liver diseases.
* ALT or AST \> 5×ULN, total bilirubin（TBIL） \> 3×ULN.
* If female: known pregnancy, or has a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating.
* Allergic to fenofibrate or ursodeoxycholic acid.
* Taking hepatotoxic drugs (e.g., dapsone, erythromycin, fluconazole, ketoconazole, rifampicin) for more than 2 weeks within 6 months, and long-term hormonal users.

Recurrent variceal bleeding, poorly controlled hepatic encephalopathy or refractory ascites.

* Patients with a history of severe cardiac, cerebrovascular, renal, respiratory disease or functional failure, and psychiatric disorders (including those due to alcohol and drug abuse).
* Creatinine \>1.5×ULN and creatinine clearance \<60 ml/min.
* Currently using statins (such as pravastatin, fluvastatin, and simvastatin), other fibrates (such as gemfibrozil and bezafibrate), and drugs structurally similar to fenofibrate (like ketoprofen).
* Planned to receive an organ transplant or an organ transplant recipient.
* Needing Liver transplantation within 1 year according to the Mayo Rick score.
* Any other condition(s) that would compromise the safety of the subject or compromise