cyrilzakka/clinical-trials huggingface dataset:
AeroEclipse II Agreement

Traditional, continuous-mode nebulizers such as the English-Wright nebulizer are designed to operate continuously with tidal breathing. As inhalation accounts for only about one-third of the respiratory cycle, two-thirds of the continuously produced aerosol is lost to the environment possibly posing a hazard any fellow-patients, family members, or health-care workers in the vicinity. The English-Wright has been the only American Thoracic Society (ATS)recommended device available on the market. Recently Roxon Medi-Tech has announced the discontinuation of the English-Wright nebulizer. For these reasons it is necessary to review the use of other nebulizers such as the AeroEclipse II breath-actuated nebulizer and further validate their performance.

The investigators expect to show equivalence between the AeroEclipse II and the English-Wright nebulizers.

This study would like to determine if the use of the Aeroeclipse II breath actuated nebulizer for the delivery of methacholine chloride bronchoprovocation agent to the lungs results in the same Provocation Concentration PC20 (provocation concentration, or dose that causes a 20% decrease in Forced Expiratory Volume in 1 sec or FEV1) as using the English-Wright nebulizer for the delivery of methacholine chloride bronchoprovocation agent to the lungs.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 10 to 65 years at time of recruitment into this study,
2. Diagnosis of current asthma by a health care professional,
3. Tidal breathing Provocation Concentration ≤ 16 mg/mL,
4. Forced Expiratory Volume 1\> 65% of predicted,
5. No respiratory tract infection or allergen exposure ≥ 4 weeks,
6. Able to complete 2 methacholine inhalation challenges on 2 separate days at the same time of day, at least 24-h apart, and within a 2-week period,
7. Inhaled salbutamol withheld for ≥8 hours prior to testing,
8. Inhaled corticosteroid maintained at same dose throughout study,
9. inhaled formoterol and salmeterol withheld for ≥36 hours prior to testing.

Exclusion Criteria:

1. Those born prematurely (more than 4 weeks early of the calculated date),
2. Those with chronic health conditions like diabetes or cystic fibrosis,
3. Smokers.
PF-06804103 Dose Escalation in HER2 Positive and Negative (Negative Only in Part 2) Solid Tumors

The study will evaluate the safety, pharmacokinetics and pharmacodynamics of increasing doses of PF-06804103 in patients with HER2 positive and negative breast and gastric cancer (HER2 positive only and gastric were studied in Part 1A only). The study will expand to look at selected doses in patients with HER2 positive and negative breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* HER2 positive breast cancer or gastric cancer that is resistant to standard therapy or for which no standard therapy is available (Part 1A only)
* HER2 positive and negative breast cancer (Part 2A)
* HER2 negative breast cancer (Part 1B \& Part 2B)
* Performance status of 0 or 1
* Adequate bone marrow, kidney and liver function

Exclusion Criteria:

* Known CNS disease including, but not limited to, metastases
* History of exposure to certain cumulative doses of anthracyclines
* Grade 3 or higher hypersensitivity reaction to prior receipt of any antibody therapy
* Active and clinically significant bacterial, fungal, or viral infection
* Abnormal cardiac function defined by a LVEF \<50% by ECHO or MUGA
* Patients with previous history or active interstitial lung disease or pulmonary fibrosis, or a history of other clinically significant lung diseases
Correct Gastric Tube Placement in Very Low Birth Weight Neonates

Gastric tube (GT) placement is a recurrent procedure in VLBW infants due to feeding impairment correlated with low birth weight.

Correct GT depth is mandatory to ensure an appropriate and safe enteral feeding: X-ray is the gold standard in order to check GT position, but this cannot be routinely performed due to x-ray exposure risk. Feeding a neonate through a misplaced GT is potentially harmful and may increase morbidity, mortality and hospitalization length.

Nurses estimate GT depth through external measurements. This study aims to identify the most appropriate insertion length predictor for orogastric tube placement in VLBW infants by comparing two different methods.

Several methods have been suggested to estimate orogastric tube insertion length, but none of them has been validated in VLBW infants. The most commonly used methods are NEX (Nose-Ear-Xyphoid) and NEMU (Nose-Ear-Mid-Umbilicus) as predictors of nasogastric tube insertion. For the purpose of the present study NEX and NEMU methods were adjusted for orogastric tube placement.

Hence, primary aim of this study is:

To identify the most appropriate insertion length predictor for orogastric tube placement in VLBW infants by comparing NEX and NEMU methods.

Secondary aim is:

- To develop a new mathematical formula, based on the neonate's weight or length, to predict the insertion length of orogastric tube in VLBW infants

Eligibility Criteria:
Inclusion Criteria:

* Birth Weight ≤1500 grams (Very Low Birth Weight Infants)
* Need for both umbilical catheter and gastric tube positioning at birth

Exclusion Criteria:

* Birth Weight \>1500 grams
* Congenital respiratory or gastrointestinal tract malformations (from oral cavity to stomach included)
* Critically unstable preterm infants will be excluded according to nurse or physician evaluation
Investigating The Experiences of Patients In Immunotherapy Clinical Trials

It has been observed before that participation in medical trials has been in favor of specific demographic groups. But research pointing out which trial attributes impact participation positively or negatively is sparse.

This study invites various participants to collect more data on their immunotherapy clinical experiences. The goal is to know which factors always limit how patients participate or complete the medical study they are first interested in.

The data obtained in the trial will be assessed through a variety of demographic lenses to discover patterns that might improve the experience of immunotherapy patients in the future.


Eligibility Criteria:
Inclusion Criteria:

* Patient has self-identified as planning to participate in an interventional clinical trial using immunotherapy
* Patient has been diagnosed with a type of cancer
* Patient is a minimum of 18 years or older

Exclusion Criteria:

* Patient has an ECOG score of 4 or higher
* Patient is not able to provide consistent digital reporting as per study requirements
* Patient does not complete Informed Consent Form
The Relation Between Thyroid , Parathyroid Hormones and eGFR in CKD Patients in Assiut

To evaluate the relation between thyroid, parathyroid hormones and estimated glomerular filtration rate in chronic kidney disease .

CKD is defined as abnormalities of kidney structure or function, present for \>3 months, with implications for health. CKD is classified based on Cause, GFR category (G1-G5), and Albuminuria category (A1-A3) .

The global prevalence of CKD is 13.4%, with 10.6% being stages 3-5 ,Over the past 10 years, the death rate due to CKD has increased by 31.7% .

CKD patients remain sometimes asymptomatic, presenting the complications typical of renal dysfunction only in more advanced stages. Its treatment can be conservative usually in patients with glomerular filtration rate above 15 ml/minute without indications of dialysis or replacement therapy .

In CKD patients the changes of endocrine system levels may arise from several causes as the kidney is the site of degradation \& synthesis of many different hormones .

So thyroid and parathyroid hormones dysfunction has been recognized as common co-morbidity that is often diagnosed with CKD .

Thyroid hormone is one of the most important hormones in the human body as it regulates majority of the body's physiological actions .

Parathyroid hormone (PTH) is one of the most important hormones required for the maintenance of calcium and phosphate homeostasis .

Chronic kidney disease metabolic bone disorder (CKD-MBD) among patients with end stage renal disease ranges from 33% to 67%, and its severity tends to increase with the progression of the kidney damage \& high mortality rates .

CKD-MBD causes bone abnormalities that affect turnover, volume, mineralization, vascular, linear growth, and density, and soft tissue calcification .

Eligibility Criteria:
Inclusion Criteria:

* 1. CKD patients 2. Age (18-80 years) 3. Diabetic nephropathy 4. Hypertensive nephropathy 5. Chronic pyelonephritis 6. Obstructive nephropathy 7. Polycystic kidney 8. Gout nephropathy 9. Nephrosclerosis

Exclusion Criteria:

* 1. Patients underage of 18 and above 80 2. Patients with history of thyroidectomy and parathyroidectomy 3. Patients with history of thyroid and parathyroid disease before diagnosis of CKD 4. Malignancy
Walnuts and Glucose Variability

Persons with type 2 diabetes mellitus (T2DM) have swings in their blood sugar levels that may lead to a higher risk of developing heart disease. An important part of diabetes management involves eating a diet to prevent large swings in blood sugar levels. Walnuts contain fat, protein and fiber that may reduce the swings in blood sugar. The purpose of this study is to compare the effects of a walnut-free American Diabetes Association (ADA) diet versus 2 levels of walnut-enriched ADA diets on blood sugar swings. Eighteen male and female adults with T2DM will participate in the study. Subjects will be randomized to consume an ADA diet with or without walnuts for 3 consecutive days every other week. Subjects must test their blood sugar twice daily and wear a continuous glucose monitor during the three 72-hour study periods. Subjects will be between 40 and 70 years of age and will be recruited from the surrounding community using flyers and public service announcements. Consent will take place in the Department of Nutrition at Loma Linda University by the study investigators. In total, subject participation will last 5 weeks and all meals will be provided during the 3 study periods.


Eligibility Criteria:
Inclusion Criteria:

* adults between age 40 and 70 years with type 2 diabetes
* duration of type 2 diabetes more than 6 months but less than 10 years
* HbA1c 6.0-8.0%
* BMI 25-40 kg/m2
* diet controlled or stable dose of metformin for at least 3 months
* willing to test blood glucose with personal meter twice a day during study test days

Exclusion Criteria:

* using oral hypoglycemic agents or insulin
* history of ischemic heart disease or congestive heart failure
* history of severe diabetic complication (neuropathy, renal failure, stroke)
* taking medication affecting glucose levels (i.e. corticosteroids)
* active infectious disease
* active malignancy
* pregnant or breast feeding woman
* smoker
* history of daily caffeine or alcohol intake
* known allergy to nuts
* lactose or gluten intolerance
Influence of Binge Drinking on Glucose Metabolism in Patients With Type 1 Diabetes - A Pilot Study

Although there is no evidence that individuals with type 1 diabetes have a different approach to alcohol compared to the background population, nevertheless, its use does have implications for patients mainly because of the risk of hypoglycaemia unawareness. However, binge drinking has been implicated as a factor in the development of ketoacidosis and is probably under-recognised. The aim of this study is to examine the effect of binge drinking on glucose, insulin, counter-regulatory hormones and other metabolites in patients with type 1 diabetes. It is hoped that data from this project will be used to develop a larger study comparing different treatment regimens for patients using alcohol to reduce the risks of hyperglycaemia as well as hypoglycaemia.

This is a randomised trial involving Type I diabetics who have had Type I diabetes \>5 years. They will be using multiple daily injections of a basal insulin and a rapid acting component.Apart from insulin and oral contraceptive, none will be on regular medication. All will be regular consumers of modest amount of alcohol (Female - less than or equal to 14 units, males - less than or equal to 21 units). Each will participate in 2 studies. Subjects will be randomised either to white wine or an equivalent volume of alcohol-free wine.Outcome measures are the results of the effect of acute ingestion of alcohol on glucose levels and intermediate metabolites in subjects with Type I diabetes.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes for \> 5 years
* Use of multiple daily injections of a basal insulin and a rapid acting component
* Regular consumption of modest amounts of alcohol

Exclusion Criteria:

* Type 2 diabetes
* Type I diabetes \< 5 years
* Excessive alcohol consumption
* Unstable diabetes
Pharmacokinetics of IV Formulation

Open label evaluation of a single intravenous dose of F901318 to healthy male and female subjects with pharmacokinetic and safety and tolerability evaluation.

Open label single intravenous dose, single group study. Eight subjects (ideally 4 male and 4 female, minimum of two females) will be studied. The drug product will be a F901318 solution for infusion (6mg/mL). The dose will be 4 mg/kg delivered in the fasted state (8 hours minimum) by intravenous infusion over 2 hours. Each subject will be on study for approximately 6 weeks. Each subject will reside at the Clinical Research Unit (CRU) from Day -1 (the day before dosing) to Day 4 (72 hours post-dose). Blood samples for pharmacokinetic evaluation will be obtained up to and including 120 hours post dose. Safety and tolerability will also be assessed.

Subjects will return to the clinical unit at 96 and 120 hours for pharmacokinetic blood sampling.

All subjects will return for a post-study visit 8 to 10 days after the dose of study medication.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects will be males or females of any ethnic origin between 18 and 55 years or age and weighing between 50 and 100kg.
2. Females of child bearing potential must be established on a reliable form of contraception and have a negative pregnancy test at screening and Day -1
3. Subjects must be in good health, as determined by a medical history, physical examination, 12-lead electrocardiogram (ECG) and clinical laboratory evaluations (hepatic transaminases must be within normal limits, congenital non haemolytic hyperbilirubinaemia is acceptable)
4. Subjects will have given their written informed consent to participate in the study and to abide by the study restrictions

Exclusion Criteria:

1. Female and male subjects who are not, or whose partners are not willing to use appropriate contraception with two reliable forms of contraception or who are not otherwise unable to conceive children (hysterectomy, oophorectomy, tubal ligation or post menopausal).
2. Subjects who have received any prescribed systemic or topical medication within 14 days of the dose administration unless in the opinion of the Investigator and the Medical Monitor the medication will not interfere with the study procedures or compromise safety
3. Subjects who have used any non-prescribed systemic or topical medication (including herbal remedies) within 7 days of the dose administration (with the exception of vitamin/mineral supplements and paracetamol) unless in the opinion of the Investigator and the Medical Monitor the medication will not interfere with the study procedures or compromise safety
Passive Stretching in Peripheral Arterial Disease Patients

Peripheral artery disease (PAD) leads to higher mortality rates and strains healthcare systems due to increased costs. It causes leg pain during walking due to reduced blood flow. Nitric oxide (NO) deficiency contributes to vascular issues in PAD, with few effective treatments available. Passive calf muscle stretching boosts NO levels, vascular health, and walking ability in PAD patients. However, the inflammatory processes underlying these improvements are unclear. This study aims to track inflammatory markers and cardiovascular changes during 12 weeks of passive stretching. Additionally, combining stretching with dietary nitrate could further enhance walking capacity by reducing reactive oxygen species. The study will monitor inflammation, vascular function, and oxidative capacity to understand the effects on functional ability in PAD patients. This research is crucial for improving physical function and addressing exercise intolerance in PAD.


Eligibility Criteria:
Inclusion Criteria:

Ankle-brachial index of 0.90 or less Stable condition for at least 3 months

Exclusion Criteria:

Habitual exercise or cardiovascular rehabilitation program during the past 3 months Critical limb ischemia, amputation, or leg pain at rest Major surgery or lower extremity revascularization in the last 3 months Heart Failure Kidney disease Beet allergy Crohn's Current smoker
Efficacy of Inhaling Bronchodilator Medications in Chronic Obstructive Pulmonary Disease

Some patients with Chronic Obstructive Pulmonary Disease (COPD) report that they are uncertain whether they achieve clinical benefit using a dry-powder inhaler (DPI). One possible explanation is that the patient is unable to inhale the dry powder bronchodilator medication into the lower respiratory tract due to a low peak inspiratory flow rate (PIFR). A PIFR \< 60 l/min is considered to be suboptimal flow for a DPI, including the Diskus device. The hypothesis of the study is that the forced expiratory volume in 1 second (FEV1) measured at two hours after inhalation of the study medication will be higher with arformoterol solution (15 mcg) from a nebulizer compared with salmeterol dry powder (50 mcg) inhaled from the Diskus.


Eligibility Criteria:
Inclusion Criteria:

* male or female patient 60 years of age or older; diagnosis of COPD; current or former smoker; previous or current use of Diskus device; PIFR \< 60 l/min using the In-check DIAL against the resistance of the Diskus device; clinically stable.

Exclusion Criteria:

* any patient who has a concomitant disease that might interfere with study procedures or evaluation; inability to withhold short-acting and long-acting bronchodilators on the days of testing
Triamcinolone Paste to Reduce the Incidence of Postoperative Sore Throat

The purpose of this study is to determine whether triamcinolone paste applied over tracheal tube is effective to reduce the incidence of postoperative sore throat after tracheal intubation.

Sore throat is a common postoperative complaint after tracheal intubation. When the surgical pain is well controlled, sore throat is often the predominant complaint, therefore it is important to prevent sore throat.

Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I-II, aged between 20 and 70 years
* scheduled for elective laparoscopic cholecystectomy under general anesthesia with endotracheal intubation

Exclusion Criteria:

* recent respiratory tract infection or sore throat
* who were using analgesics or steroid preoperatively
* who have risk factors for oral cavity infection
* the surgical duration \< 60 minutes or \> 300 minutes
Evaluating Heat Transfer With the Esophageal Cooling Device

An esophageal heat exchange tube will be inserted in anesthetized surgical patients. Each patient will have 30 minutes of cooling (circulating fluid at 7 degrees C) and 30 minutes of warming (42 degrees C) with 15-minute recovery break in between. The primary outcome will be heat transfer, determined from inflow and outflow temperatures and fluid flow rate for cooling and warming modes.

The ECD is made with medical-grade silicone and has 3 ports; 2 coolant ports and a central port. The coolant ports of the ECD are connected to external heat exchanger while a third, central lumen simultaneously allows gastric decompression and drainage. The ECD can be inserted like a standard gastric tube.

The aim of this prospective, interventional study is to quantify heat transfer during warming and cooling using the Esophageal Cooling Device in anesthetized patients having non-cardiac surgery.

An esophageal heat exchange tube will be inserted in anesthetized surgical patients. Each will have 30 minutes of cooling (circulating fluid at 7 degrees C) and 30 minutes of warming (42 degrees C) with 15 -minute break in between; the order of the cooling and warming will be randomized. The primary outcome will be heat transfer, determined from inflow and outflow fluid temperatures and fluid flow rate assessed for both cooling and warming modes.

Eligibility Criteria:
Inclusion Criteria:

* Elective non-cardiac surgery;
* Age 18-80 years;
* Surgery expected to last \>2 hours;
* General anesthesia with endotracheal Intubation;
* Volatile anesthesia;
* BMI \< 38 kg/m2;
* ASA physical status 1-3.

Exclusion Criteria:

* Weight \< 45 kg;
* Unstable blood pressure;
* Known esophageal deformity or evidence of esophageal trauma or esophageal disease that in the opinion of the attending anesthesiologist precludes safe use of ECD.
Clinical Evaluation of RTX Locator Attachments for Implant-supported Mandibular Complete Overdenture

This study was conducted to clinically and radiographically evaluate locator RTx attachments for two implant-supported mandibular overdenture using two loading protocols

Thirty edentulous patients received two implants in the interformaninal region in the canine area . According to the loading protocol used for attaching mandibular overdenture, patients were randomly assigned into two equal groups. Group I (control): patients who would be delivered mandibular implant overdenture retained by two RTx locator attachments using conventional loading protocol. Group II (study): patients who would be delivered mandibular overdenture retained by two RTx locator attachments using early loading protocol. Peri-implant tissue health \[Plaque (PL) and (GI) gingival scores, pocket depth (PD), and crestal bone loss (CBL)\] were evaluated immediately after denture insertion (T0), 6 (T6), and 12 (T12) months after insertion.

Eligibility Criteria:
Inclusion Criteria:

* adequate bone quantity \[class III -V according to Cawood and Howell in the interforaminal area of the mandible to receive 2 implants (4×13 mm)
* adequate restorative space \[12-15 mm from the mucosa of the mandibular ridge to the occlusal plane, Class I according to Ahuja and Cagna for RTX supported implant overdenture.

Exclusion Criteria:

* systemic diseases that contraindicate implant placement
* bone metabolic diseases as diabetes mellitus
* irradiation of the head and neck region
* chemotherapy within the past 3 years
* smoking habits.
Double-layer Versus Purse Uterine Closure Techniques : Impact on Residual Myometrial Thickness After Cesarean

There are different surgical techniques of uterine closure during cesarean. Currently data suggest that the double layer unlocked closure technique is associated with better uterine scar healing, and this technique is considered the gold standard.

This study compares two techniques of uterine closure on myometrium thickness:

1. Double layer unlocked suture;
2. Purse suture of the uterus with a first continuous purse suture of the deep portion of the myometrium and a second unlocked continuous suture including the remaining part of the myometrium.

The primary outcome is the mean residual myometrium thickness at the site of the uterine scar evaluated by transvaginal ultrasound at six months after cesarean.


Eligibility Criteria:
Inclusion Criteria:

* Planned cesarean
* Primary cesarean
* ≥ 38 gestational weeks

Exclusion Criteria:

* Previous cesarean
* Women \< 18 years old
* Multiple gestation
* Mullerian anomalies
* Active labor
* Diabetes
* BMI \>35 kg/m2
* Placenta praevia
* Chronic systemic disease
* Covid-19 infection