cyrilzakka/clinical-trials huggingface dataset:
Comparison of Efficacy of Dexamethasone and Methylprednisolone in Moderate to Severe Covid 19 Disease

The investigator will select participants with moderate to severe covid 19 disease admitted in Fatima memorial hospital. The investigator will divide them in two groups according to convenience sampling. Group 1 will be given dexamethasone 8mg/day and group 2 will be given methylprednisolone 1mg/kg/day IV for 5 days. The investigator will compare the improvement in temperature, oxygen requirement and CRP level at day zero and day 5 in both the groups.

The investigators enrolled first 100 participants admitted in covid unit of Fatima memorial hospital who fulfilled the inclusion criteria and signed informed consent. Baseline oxygen saturation and clinical findings were noted. Chest x-ray was done on admission. Baseline labs were sent, initial level of CRP (C-reactive protein) was noted down.

Patients with oxygen saturation \< 94% on room air with normal chest x-ray and CRP between 30 - 50, were labelled as having moderate covid 19 disease. Patients with CRP\> 50 and having infiltrates on chest x-ray at the time of admission were considered having severe covid 19 disease. Intravenous methylprednisolone in a dose of 1 mg/kg/day in 2 divided doses or dexamethasone 8 mg/day IV was given to alternate patients for 5 days. After 5 days, the investigator again recorded the oxygen saturation, CRP level and repeat chest x-ray findings.

Patients were given tocilizumab and convalescent plasma as and when indicated. Oxygen was given by nasal cannula and face mask. Patient was shifted to ICU if clinical condition deteriorated and/or mechanical ventilation is needed.

The investigator noted the improvement in clinical, radiological and biochemical parameters of the patient on day 0 that is admission day and later on day 5 after giving steroids (methylprednisolone or dexamethasone) for 5 days.

Data was analyzed using SPSS version 25.0. Descriptive statistics like frequency and means were calculated. Paired sample t-test was applied for comparison of the two groups.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 to 75 years
2. Covid PCR positive
3. Patient having oxygen saturation \< 94% on room air, regardless of chest x-ray findings
4. Moderate or severe covid 19 disease according to operational definition.
5. Patients who sign informed consent.

Exclusion Criteria:

1. Severe immunosuppression like HIV( Human immunodeficiency Virus) or long term use of immunosuppressant for any other chronic illness
2. Patients who need corticosteroids for any other disease like asthma, rheumatoid arthritis.
3. Pregnant or lactating females
The Effect of BiosLife on Serum Lipids

This is a double-blind, placebo-controlled study to assess the effectiveness of BiosLife in lowering serum LDL cholesterol and raising HDL cholesterol. BiosLife is a natural supplement (mixed in water and taken twice daily) which contains guar gum and other natural soluble fibers, phytosterols, policosanol, and a proprietary chrysanthemum extract. Approximately 100 subjects with baseline LDL cholesterol of 110-190 mg/dL will be randomized in a 2:1 ratio to BiosLife or a look-alike placebo. Changes in lipids from baseline will be assessed at 6 weeks and 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* LDL-C 110 - 190 mg/dL
* For current lipid-lowering prescription therapy users, the dose of lipid-lowering medication must have been constant for 3 months with no current plan for change in dose.
* Age 18 - 85 years

Exclusion Criteria:

* Type 1 diabetes
* Severe hypertension, defined as at least 180 / 100 mmHg
* Any other health condition that may interfere with the study results, as judged by the principle investigator
* Allergy against any of the ingredients in the tested product
* Any medical condition, in which fiber consumption is contraindicated (e.g. Crohn's disease
* The use of nutritional supplements during the last two months containing one or more similar ingredients, as the tested supplement.
* History of alcohol or drug abuse, psychological or other mental issues that are likely to invalidate informed consent, or limit the ability of the patient to comply with the protocol requirements
* Participation in any other studies involving investigational or marketed product concomitantly or within one month prior to entry into the study
* Pregnant or breast feeding
* Persons who eat only 1 meal per day
Glucose Tolerance in Children With Cystic Fibrosis

The aim is to describe the association of glucose tolerance measured with three different tools (continuous glucose measurement system - CGMS, oral glucose tolerance testing - OGTT and optional intravenous glucose tolerance testing -IVGTT) with parameters out of lung function and anthropometric parameters in patients with cystic fibrosis.

Patients with cystic fibrosis (CF) with progressing disease are developing a glucose tolerance which resembles the metabolic state of a diabetic patient because of increasing impairment of endocrine pancreatic function. The prevalence of this diabetic metabolic state is increasing with age, reaching around 20% at the age of 20 years.

Over the last decade, research has already highlighted the negative influence of cystic fibrosis related diabetes (CFRD) on morbidity and mortality after the diagnosis of this condition.

As the deterioration in nutritional status and lung function can already be noticed 2-6 years before the onset of CFRD, the importance of early diagnosis in glucose abnormalities and its treatment therefore is crucial.

The currently used method to evaluate altered glucose metabolism in patients with CF is an annual oral glucose tolerance test (OGTT) with the glucose value after 120 min after oral ingestion of glucose-fluid as reference. This method may detect CFRD much later than we see deterioration of lung function and weight loss. This deterioration and the mortality in CF is related to CFRD.

An alternative diagnostic tool that has gained increasing attention and that is already routinely used in pediatric patients with diabetes mellitus type I is the continuous glucose monitoring system (CGMS) which was shown to be much more sensitive in detecting glucose abnormalities. To assess pancreatic endocrine dysfunction - the pathophysiologic cause for glucose intolerance - intravenous glucose tolerance testing (IVGTT) is the gold standard.

The investigator's aim is to describe the association of glucose tolerance measured with three different tools/assessment procedures (CGMS, OGTT and optional IVGTT) with lung function and anthropometric parameters.

Eligibility Criteria:
Inclusion Criteria:

* Patients with confirmed cystic fibrosis aged between 10-20 years, under medical treatment at the University Children's Hospital Basel UKBB and at the University Children's Hospital, Inselspital Bern

Exclusion Criteria:

* Patients being under medical treatment with systemically administered glucocorticoid drugs or intravenously administered antibiotic treatment within 6 weeks before glucose tolerance testing.
* Patients with acute pulmonary exacerbation, defined by a pediatric pneumologist
CK-0045 Proof-of-concept Study in Participants with Overweight / Obesity and Type 2 Diabetes

The goal of this clinical trial is to learn if treatment with CK-0045 improves blood sugar control after a meal in participants with type 2 diabetes mellitus (T2DM) and overweight/obesity. It also aims to learn if CK-0045 can reduce body weight in these patients.

The main question it aims to answer is:

• Does 16 weeks of treatment with CK-0045 improve blood sugar control after a meal in participants with overweight or obesity and T2DM? Researchers will compare two dose levels of CK-0045 to a placebo arm (a look-alike substance that contains no drug) to see if CK-0045 improves blood sugar control.

Participants will:

* Have CK-0045 or placebo injected subcutaneously (under the skin) once weekly over a period of 16 weeks.
* Visit the clinic 24 times and stay overnight at 2 of the visits.
* During the visits blood samples will be collected and several other assessments/examinations will be performed to learn about the effects (and potential side effects) of CK-0045.

Phase 2a, single-center, randomized, double-blind, placebo-controlled, parallel group trial with weekly SC dosing of CK-0045 (2 dose levels) or placebo over 16 weeks followed by 8 weeks of follow-up in participants with overweight / obesity and T2DM. The total duration of involvement for each participant, screening through follow-up, will be approximately 30 weeks.

Eligibility Criteria:
Key Inclusion Criteria:

* 18-74 years old male or female diagnosed with type 2 diabetes mellitus ≥ 6 months prior to screening
* Body Mass Index (BMI) between 27.0 and 40.0 kg/m\^2 at screening
* Treated with diet and exercise
* HbA1c 6.5-8.5%, both inclusive, at screening for participants taking 3 antidiabetic medications or HbA1c 6.5-9.0%, both inclusive, at screening for participants taking 2 or less antidiabetic medications at stable doses for at least 3 months prior to screening

Key Exclusion Criteria:

* Any of the following within the past 6 months prior to screening: myocardial infarction, unstable angina, coronary artery bypass graft, percutaneous coronary intervention (diagnostic angiograms are permitted), transient ischemic attack, cerebrovascular accident or decompensated congestive heart failure, or currently have New York Health Association Class III or IV heart failure or any other clinically significant history or evidence of poorly controlled cardiovascular disorder(s) as judged by the investigator.
* Have a known clinically significant gastric emptying abnormality (for example, severe diabetic gastroparesis or gastric outlet obstruction), have undergone gastric bypass (bariatric) surgery or restrictive bariatric surgery (for example, gastric banding ), and/or device-based therapy for obesity, or have had device removal within the past 6 months.
* History or signs of clinically relevant skin diseases including but not limited to: psoriasis, atopic dermatitis, eczema, etc., as judged by the investigator.
Study to Evaluate the Effect of Micardis® / MicardisPlus® on Metabolic Parameters in Patients With Essential Hypertension and Diabetes Mellitus

The primary objective is to evaluate the effect of the treatment with Micardis® or MicardisPlus® on blood pressure. Secondary objectives are the effect of Micardis® / MicardisPlus® on metabolic parameters (triglycerides, cholesterol, blood glucose and HbA1c) in patients with essential hypertension and diabetes mellitus


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Hypertension
* Diabetes mellitus

Exclusion Criteria:

* Age \< 18 years
Safety of PET MPI Using the CRCHUM N-13 Ammonia

Positron emission tomography (PET) myocardial perfusion imaging (MPI) is an examination that helps to assess the function and perfusion of the heart. Completion of this examination requires the injection of a small dose of a radiotracer (a radioactive substance).

PET MPI is a state-of-the-art non-invasive cardiac imaging tool. The main goal of the PET MPI examination is to assess if one or more of the arteries feeding blood to your heart are blocked. This examination replaces an older technology (single photon emission computed tomography, or SPECT), and allows the obtention of more accurate information, and new information that the older SPECT technology did not assess. The radiation dose received as part of the procedure is also smaller with PET versus SPECT.

One of the substances which can be used for PET MPI is called N-13 ammoniac (NH3). For this clinical study, NH3 which will be produced at the Centre de Recherche du Centre Hospitalier de l'Université de Montréal (CRCHUM), per the standards and methods prescribed by Health Canada. NH3 is not currently approved for clinical use by Health Canada. It is thus considered and experimental substance in the context of this study.

Participants will undergo PET MPI with the CRCHUM NH3. The PET MPI procedure itself is not an experimental procedure and is not part of the research protocol. Only the use of NH3 produced at the CRCHUM is experimental.

The main objective of this research study is to validate the production process and assess the safety of the NH3 produced at the CRCHUM cyclotron. Secondary objectives include the assessment of prescription practices amongst physicians who refer patients for PET MPI, and how they will change over time.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient being referred for clinically indicated positron emission tomography myocardial perfusion imaging at the Centre hospitalier de l'Université de Montréal

Exclusion Criteria:

* Pregnant women
* Claustrophobic patient unable to undergo the examination
* Breastfeeding women unwilling to temporarily stop breastfeeding
* Patient with contra-indication to: dipyridamole, aminophylline, dobutamine or exercise stress test (depending on the method of cardiovascular stress test chosen)
A Pilot Study to Evaluate the BodyLogic TM System (Mentor) in Augmentation Mammaplasty

At a national level of 15%, the reoperation rate following augmentation mammaplasty is too high. We are conducting a survey to examine the pre-operative methods by which plastic surgeons determine implant volume, size, shape and location; and to determine if the Mentor "BodyLogic"TM System can successfully improve outcomes. We will evaluate how measurements taken using "BodyLogic"TM influence choice of implant and whether there are any re-operations, particularly for size change. We hypothesize that using this system will help surgeons choose appropriate implants that will decrease the rate of reoperations, especially for size change.

We are planning to survey 10 high volume plastic surgeons that perform at least 10 breast augmentations a month and to collect data on at least 300 patients. The enrollment period will be 3 months.

As part of this study, we are having the following steps performed:

1. Complete a 'general preference questionnaire', designed to document current preoperative planning and assessment methods for breast augmentation.
2. For each study patient, a pre-operative "BodyLogic"TM worksheet will be completed. Then, using the provided Implant Selection Booklet, the actual implant will be selected. The surgeon will maintain a key of the patients, and will identify them to the investigators only by subject number, and return these forms in provided stamped, self-addressed envelopes.
3. The patient returns at 1-3 months and 8-12 months for completion of the respective "Body-Logic" post-operative worksheets for each visit and the surgeon will send us the data in the provided envelopes periodically.
4. If during the course of the data collection, the surgeon has to re-operate on any patient, he/she will fill the "re-operative form" and send it to us.
5. Finally, the surgeon will complete a post-study evaluation questionnaire to help us understand how the "BodyLogic"TM System worked for him/her and how it could be improved.

Eligibility Criteria:
Inclusion Criteria:

* Female (age \> 22 years)
* Cosmetic Breast Augmentation only
* Primary breast augmentation

Exclusion Criteria:

* Breast reconstruction
* Secondary breast augmentation
* \<22 years of age
Safety and Performance Evaluation of multiPlus Dialysate During CRRT

Assessment of the performance of multiPlus dialysate based on the serum creatinine removal 6 hours (360 min) after start of continuous veno-venous haemodialysis/ haemodiafiltration \[CVVHD(F)\].

multiPlus is a phosphate-containing dialysis solution for the use in continuous renal replacement therapy (CRRT) during acute kidney injury (AKI).


Eligibility Criteria:
Inclusion Criteria:

* Signed and dated informed consent form by investigator and by

  * a) the study patient: if patient is able to consent
  * b) the legal representative: if patient is unable to consent:
  * c) an independent consultant: in case of emergency
* if c) either legal representative or study patient, whichever can be done sooner, should be informed by the investigator as soon as possible. If the informed consent has been obtained by the legal representative (b or emergency scenario) informed consent to continue the participation in the clinical investigation shall be obtained from the subject as soon as he or she is capable of giving informed consent (According to the MDR - Article 68 - Clinical investigations in emergency situations)
* Minimum age of 18 years
* Ability to understand the nature and requirements of the study (if patient is conscious)

Study specific:

* Body weight greater than 40 kg
* Acute Kidney Injury (AKI) with clinical indication for CVVHD/CVVHDF
* Vascular access allowing blood flow of min 50mL/min
* Estimated life expectancy greater than 3 days

Exclusion Criteria:

* Any conditions which could interfere with the patient's ability to comply with the study
* In case of female patients: pregnancy (negative pregnancy test for women below 55 years) or lactation period
* Participation in an interventional clinical study during the preceding 30 days
* Previous participation in the same study
* SARS-CoV 2 positive

Study specific

* Hyperphosphataemia (\>4.5 mg/dL)
* Hypersensitivity to heparin or known history of heparin induced thrombocytopenia (HIT Type II)
* Uncontrolled bleeding and coagulation disorders
* Decision to limit therapeutic interventions
* Advanced malignancy (not including myeloma)
* Dementia (if definitely not an acute confusional state from uraemia or other acute illness)
* Advanced cirrhosis with encephalopathy in the absence of possible liver transplantation
To Evaluate the Efficacy of Z-338 in Subjects With Functional Dyspepsia

To Evaluate the efficacy of Z-338 in subjects with Functional Dyspepsia, focusing on the assessment of subjective symptoms in order to further determine the optimal dosage and efficacy parameters for PhaseIII clinical trials.


Eligibility Criteria:
Inclusion Criteria:

* Postprandial fullness, upper abdominal bloating and/or early satiety should be at least moderate for 2 days or more at the 7 days at Visit 1
* upper abdominal pain, upper abdominal discomfort, postprandial fullness, upper abdominal bloating, early satiety, nausea, vomit and belching should be at least moderate for at least 2 symptoms for 2 days or more at the 7 days at Visit 1

Exclusion Criteria:

* subjects taht heartburn should be the most bothersome symptom
* Subjects presenting with primary complaints relieved by stool movements (IBS)
* Subjects with diabetes by treatment
* Subjects taht heartburn should be more than moderate
Compliance With ERAS and Five Year Survival After Colorectal Cancer Treatment

The Enhanced Recovery after Surgery (ERAS) protocol has transformed perioperative care, representing a significant paradigm shift in managing colorectal cancer patients. While the immediate benefits of Enhanced Recovery After Surgery (ERAS) in expediting postoperative recovery are well-documented and widely acknowledged, it is essential to investigate its long-term implications, particularly its influence on survival rates. The aim of this study will be to analyse the impact of compliance with the ERAS protocol on long- term outcomes after laparoscopic colorectal resection.

The aim of this study will be to analyse the impact of compliance with the ERAS protocol on long- term outcomes after laparoscopic colorectal resection.

The study will be designed as a prospective observational study to compare the long-term effects of surgical treatment of colorectal cancer in two groups of patients: those with high compliance with the ERAS protocol (≥80%) and those with low compliance with the ERAS protocol (\&lt;80%).

The primary outcome of the study will be the 5-year survival rate. The inclusion criteria for Group 1 will involve 128 patients with ERAS compliance below 80%. Conversely, Group 2 will consist of 340 patients, all of whom achieved a compliance rate of at least 80%.

The correlation between compliance with the ERAS protocol and 5-year survival will be assessed using the Kaplan-Meier method with log-rank tests. Additionally, survival analysis will be conducted separately for groups with varying cancer stages.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing treatment for colorectal cancer

Exclusion Criteria:

* primary open or emergency surgery,
* transanal endoscopic microsurgery (TEM),
* stage IV of the disease according to the American Joint Committee on Cancer (AJCC) classification,
* multivisceral resection,
* concomitant inflammatory bowel diseases,
* intensive care unit stay immediately after surgery
* lost-to-follow-up patients.
[18F]HX4 PET/CT Imaging for Detection of Hypoxia

The aim of this study is to investigate the radiotracer \[18F\]HX4 for non-invasive detection of hypoxia in patients with head and neck, or lung cancer. Each participant will undergo a diagnostic \[18F\]HX4 PET/CT scan before beginning radiotherapy treatment. Patient follow up data will be collected from routine appointments, and analysed with the hypoxia scan results to assess whether \[18F\]HX4 PET/CT scanning can predict patient outcome from radiotherapy treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients with:

  1. biopsy proven non-small cell carcinoma of the lung \>2.5 cm in size with any T and N status but M0 who have elected to undergo radical radiotherapy or chemo-radiotherapy with curative intent or
  2. squamous cell carcinoma of the upper aerodigestive tract with a primary tumour or nodal mass \>2. 5 cm in size, with any T and N status but M0 who have elected to undergo radical radiotherapy or chemo-radiotherapy with curative intent.
* Participant must be willing and able to give informed consent for participation in the study.
* Patients must be 18 years old or above.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
* Have normal renal function, defined by creatinine clearance of \>60 mL/min.
* Able to remain still in the supine position on the scanner bed for the 40 minute duration of the examination.
* Able (in the Investigators opinion) and willing to comply with all study requirements.
* Willing to allow his or her General Practitioner and hospital consultant, if appropriate, to be notified of participation in the study

Exclusion criteria

* Patients who are scheduled for surgery prior to radiotherapy will not be included.
* Female participant who is pregnant, lactating or planning pregnancy during the course of the study.
* Chronic kidney disease stage III or worse, as defined by the NKF clinical practice guidelines (GFR \<60 mL/min per 1.73 m3 for 3 months or more).
* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of involvement in the study, or may influence the result of the study, or the participant's ability to participate in the study.
* Participants who have been involved in another research study involving an investigational product in the past 12 weeks.
* Previous surgery or radiotherapy to the upper aerodigestive tract or lung, which in the opinion of the Investigators could compromise the data.
* Previous cancer diagnosis.