cyrilzakka/clinical-trials huggingface dataset:
ProAlgaZyme Novel Algae Infusion: Applications in Metabolic Syndrome

The purpose of this study is to compare the effects of supplementation with ProAlgaZyme (a novel fermentation product of a freshwater algae ecosystem) vs. placebo on Metabolic Syndrome and indicators of cardiovascular health including: body weight and fat, blood lipids, inflammatory markers such as hsCRP, blood pressure and fasting blood glucose.

Metabolic syndrome, a set of symptoms strongly associated with increased risk for both cardiovascular disease and diabetes, is generally linked to obesity and has become a serious problem in many industrialized countries. Agents that aid in weight loss or help to normalize blood lipids or inflammation may reduce the risk of metabolic syndrome and therefore, reduce the risk of cardiovascular disease and diabetes. This study is a single-center, double-blind, placebo-controlled, parallel design, to evaluate the effects of ProAlgaZyme (4 fl. oz. daily) on metabolic syndrome and markers of cardiovascular health including blood lipids, inflammatory markers and anthropometric measurements.

Comparisons: ProAlgaZyme vs. placebo \[Time frame: 10 weeks\]

Eligibility Criteria:
Inclusion Criteria:

* Participants must meet 3 of the following criteria:

  * BMI ≥30 kg/m2
  * HDL Cholesterol of \<40
  * Triglycerides \>150 mg/dl
  * Fasting blood glucose \>100 mg/dl
  * Blood pressure \>130/85 mm Hg
  * Total Cholesterol of \>200 mg/dl
  * LDL Cholesterol of \>160 mg/dl
  * Interleukin 6 (IL-6) \>5pg/mL

Exclusion Criteria:

* Morbidly obese: BMI \>40 kg/m2
* Taking any cholesterol-lowering medications 30 days prior to the start of enrollment and during the course of the study.
* Enrolled in another clinical study in the past 6 months.
* Pregnant, actively infected, on medication that interfered with healing (for example, steroids), were inflicted with systemic disease such as AIDS, HIV, active hepatitis or active malignancy (clinical signs within the past 5 years), or suffered from diabetes mellitus requiring daily insulin management.
The Effect of Bone Mineral Density in Patients With Adult Cystic Fibrosis

The study was conducted in the age range of 18-45 December, who were diagnosed with Cystic fibrosis.

60 voluntary patients who have signed the consent form will be included. Within the scope of the research the demographic information of the individuals will be recorded. Functional capacities of individuals With the Shuttle Walking Test at Increasing Speed, respiratory functions respiratory function test, with measurements of respiratory November muscle strength and endurance, the level of dyspnea was Modified Medical Peripheral November muscle strength hand dynamometers with Research Council (mMRC) Dyspnea Scale posture assessment with the Corbin Posture Analysis Scale, trunk mobility with the Trunk Pelvis-Hip Angle Test, core stabilization with Sahrmann's Core Stability Test, individuals' perception of cosmetic deformity Walter Reed visual assessment questionnaires

Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 18-45 who were diagnosed with Cystic Fibrosis

Exclusion Criteria:

In the last year, patients;

* who had a fracture in any part of the patient's body
* who had undergone spine surgery
* who had an orthopedic, neurological or metastatic history in addition to Cystic Fibrosis
A New Prognostic Score Model for Pancreatic Ductal Adenocarcinoma

The AJCC TNM staging system is the prevailing method in prognostic evaluation of pancreatic ductal adenocarcinoma (PDAC) at present , but it did not include factors such as the tumor immune microenvironment that are known to exert a profound impact on patients'clinical outcome. This study was aimed to develop a comprehensive and effective prognostic score model to predict prognosis and guide clinical management for postoperative PDAC patients.


Eligibility Criteria:
Inclusion Criteria:

1. Pathologically confirmed PDAC
2. Achievement of surgical resection (including radical or palliative surgery)

Exclusion Criteria:

1. Lost to follow-up
2. Simultaneous presence of other tumors
3. Died in three months after surgery
Maxillary Patient Specific Implants in Bimaxillary Orthognathic Surgery

Orthognathic surgery is a type of jaw surgery where a surgeon cuts the bones of the upper and lower jaw and places them better. There are two ways they can put the bones in the correct place and keep them in place after the surgery. One way, called the "conventional method", is to use a 3D-printed guide called a splint to set the bones in the right place and then screw the bones together using metal plates that the surgeon bends into shape to fit during the surgery. Another way is to use a patient-specific implants (PSI) that has been 3D-printed in titanium beforehand that because of its unique shape both places and keeps all the bones in the correct place after they are screwed in. Both ways of doing it are golden standards, meaning they are already approved.

Measuring the accuracy of the surgery is done by comparing the positions of the bones after the surgery with the intended positions of those bones, according to the surgical plan. The closer the achieved position of each bone is to the intended position, the more accurate the result.

Measuring the stability of the surgery is done by comparing the positions of the bones after the surgery with the positions of the bones two years later. The less the position is changed, the more stable the result.

The goal of this clinical trial is to see how accurate and stable PSIs are in orthognathic surgery when the maxilla is split in 3 pieces, and to compare them with the conventional method in patients with overjet or overbite. The main questions it aims to answer are:

* Does using PSIs provide accurate movements of the maxilla pieces?
* Does using PSIs provide more accurate movements of the maxilla pieces than the conventional method?
* Does using PSIs provide stable movements of the maxilla pieces after 2 years?
* Does using PSIs provide more stable movements of the maxilla pieces than the conventional method?

Participants will get orthognathic surgery as part of their normal orthodontic treatment.

Investigators will compare the PSI and conventional groups to see if the PSIs are more accurate than the conventional method.


Eligibility Criteria:
Inclusion Criteria:

* Mandibular retrognathia
* Occlusion class II
* Three-piece Le Fort I osteotomy, as part of bimaxillary orthognathic surgery with or without genioplasty

Exclusion Criteria:

* Cleft lip
* Craniofacial syndromes
* Former trauma
* Obstructive sleep apnea
Determining the Clinical Relevance of the Interaction Between Enzalutamide and the Opioid Morphine and the DOAC Edoxaban

Enzalutamide is one of the oncolytic drugs that showed efficacy and safety in most of the features of prostate cancer. Approximately 17% of the patients treated with enzalutamide need pain control. Nearly all opioids are metabolized through one of the CYP enzymes induced by enzalutamide, making optimal pain management difficult. For pain control, while using enzalutamide, morphine is being advised since morphine is mainly glucuronidated by UGT2B7 and to a lesser extent UGT1A1. Enzalutamide is in vitro an inducer of UGT1A1 and may inhibit UGT2B7 which could alter morphine concentrations, though the clinical relevance of this interaction is unknown.

In patients with cancer, Direct Oral Anticoagulants (DOACs) are frequently used since vitamin-K antagonists were reported less effective than DOACs in preventing thromboembolic events. However, DOACs are all metabolized through CYP3A4 or P-gp. Due to interaction potential with DOACs, patients treated with enzalutamide are switched to Low Molecular Weight Heparin (LMWHs) administered subcutaneously which is considered safe but less patient friendly. For patients comfort DOACs are preferred over the use of LMWHs. Since rivaroxaban and apixaban are both major substrates for CYP3A4, combination with enzalutamide is prohibited. Dabigatran is a DOAC which is only metabolized by P-gp and edoxaban is a minor substrate for CYP3A4. Therefore, both might be safe to combine with enzalutamide. However, in patients with an active malignancy edoxaban is preferred according to national guidelines. Still, it is unknown if enzalutamide has a significant effect on the edoxaban exposure.

The purpose of this study is to evaluate the effect of enzalutamide on morphine and edoxaban pharmacokinetics.


Eligibility Criteria:
Inclusion Criteria:

* Patients with prostate cancer who will start treatment with enzalutamide within label
* Patients who are on treatment with opioids and/or therapeutic anticoagulation, that are treated with or willing and able to switch to morphine (2 dd extended release equivalent dose) and/or edoxaban (30mg or 60mg OD, according to the label)
* Age at least 18 years
* Patients who are able and willing to give written informed consent prior to screening
* Patients from whom it is possible to collect blood samples
* Life expectancy of \> 3 months
* Stable renal function and renal clearance \> 50ml/min

Exclusion Criteria:

* Patients who are co-treated with drugs that could interfere with the metabolism of enzalutamide, edoxaban and/or morphine
Monitoring of the Cerebral Tissue Oxygenation and Perfusion in the Adapting Climber During Sleep in High Altitude

One of the major challenges in adapting to high altitudes is that with increasing altitude sleeping quality declines rapidly. Thus, the night sleep can only provide limited to none regeneration. It usually takes a prolonged stay at a constant altitude to adapt sufficiently to the altitude and to have a refreshing night sleep. 1975 Reit et. al showed in their EEG-recordings that the sleep architecture (the regular succession of the particular sleep phases) is disturbed by repeating arousals which occur due to an irregularity in the breathing rhythm.

The purpose of this study is to create a better understanding of the underlying mechanisms that lead to failed acclimatization and AMS, due to sleep disturbance.

Under sea level conditions humans breath between 10 and 12 times per minute. The breathing cycle in high altitude is accelerated. If the conscious breathing control vanishes during sleep a periodic breathing with alternating episodes of hyperventilation and apnea is the result. This circumstance causes repetitive arousals that do not allow a normal sleep pattern. The associated adverse effects are fatigue, slow or failed acclimatization, weakening of the immune system, lack of motivation and the disability to make rational decisions.

Sleep deprivation is a common reason for the abortion of a trip, accidents and severe forms of Acute Mountain Sickness (AMS).

Eligibility Criteria:
Inclusion Criteria:

* Age: 18 - 80 years
* voluntary participation in an expedition to Mount Kilimanjaro

Exclusion Criteria:

* obstructive or restrictive respiratory disorder
* hemodynamic relevant cardiac defect
* sleep disorder
Physical Exercise and Telephone Follow-up Mediated by Telerehabilitation

Cardiovascular diseases are the leading cause of death and disability globally, accounting for approximately 31% (17.9 million) of all deaths each year. The COVID-19 pandemic has led to the total suspension of most cardiac rehabilitation programs at the highest peaks of the spread, forcing people not to leave home, enhancing metabolic conditions and generating further complications due to sedentary lifestyle. Physical exercise is an essential component in the rehabilitation of patients with heart failure disease, evidencing improvements in quality of life, functional capacity, in addition to reducing the mortality rate, number of rehospitalizations, and levels of depression. It is necessary to carry out interventions adapted to the needs of patients who have difficulties traveling to health centers, however, some authors report that remotely oriented exercise could present results similar to those of traditional rehabilitation in a center or Therefore, promoting a cardiac telerehabilitation program together with telephone educational follow-up could cause greater improvements compared to other cardiac rehabilitation and telerehabilitation programs.

Objective: To determine the effects of a physical exercise program and telephone educational follow-up mediated by cardiac telerehabilitation in patients with heart failure on functional capacity, depression, and health-related quality of life.

A randomized controlled clinical trial type study will be carried out, in a period of 6 months between the year 2022, in patients with a diagnosis of heart failure who enter a cardiac rehabilitation program in the city of Santiago de Cali, Colombia, linking to the research after the consultation with cardiology in three groups: physical exercise program and conventional educational component with telephone follow-up (Intervention), physical exercise program and conventional educational component mediated by cardiac telerehabilitation, to which measurements of sociodemographic variables and clinical before-after measurements (physiological, paraclinical, anthropometric) functional capacity, quality of life and state of depression.

Eligibility Criteria:
Inclusion Criteria:

* patients previously diagnosed by a Cardiology Specialist with heart failure.
* Patients who present an indication to exercise.
* Patients who have digital equipment such as a computer, tablet or cell phone with access to virtual platforms to carry out exercise sessions mediated by technology.
* Participants who accept and sign the informed consent.

Exclusion Criteria:

* Patients with respiratory comorbidity or who present some limitation to perform active and resisted movements (recent fractures, recent hemodynamic alterations, coronary disease event after the diagnosis of cardiovascular disease, infectious diseases and neuromuscular limitation).
A Study of JNJ-67484703 in Participants With Active Rheumatoid Arthritis

The purpose of this study is to evaluate safety and tolerability of JNJ-67484703 administrations in participants with active rheumatoid arthritis (RA).

JNJ-67484703 is a humanized immunoglobulin G1 kappa (huIgG1κ) antibody that is being developed as a treatment for systemic autoimmune disorders. The primary hypothesis of this study is that treatment with JNJ-67484703 as compared to placebo will result in a similar tolerability and safety profile, as a measure of participants with abnormalities in vital signs, physical examinations, and laboratory safety tests. This study will be conducted in 3 phases: screening phase (up to 6 weeks), treatment phase (up to 10 weeks), and follow-up phase (up to 14 weeks). The duration of study participation will be approximately 30 weeks. Safety assessment like electrocardiogram (ECG), adverse events will be performed during the study. Efficacy assessment like joint assessments, pain assessments, RA joint pain severity assessment, patient's and physician's global assessment of disease activity, health assessment questionnaires, duration of morning stiffness, functional assessment of chronic illness therapy-fatigue will be performed during the study.

Eligibility Criteria:
Inclusion Criteria:

* Demonstrated an inadequate response to, or loss of response or intolerance to: at least 1 conventional synthetic disease-modifying antirheumatic drug (csDMARD) and/or up to 2 biologic DMARD (bDMARD)/targeted synthetic DMARD (tsDMARD)
* Have C-reactive protein (CRP) greater than or equal to (\>=) 0.3 milligrams per deciliter (mg/dL) at screening
* Medically stable on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening
* Have a diagnosis of rheumatoid arthritis (RA) (American College of Rheumatology \[ACR\]/ European League Against Rheumatism \[EULAR\] criteria 2010)
* Body weight within the range of 50.0 kilograms (kg) to 120.0 kg, inclusive, and have a body mass index (BMI) of 19.0 kilograms per meter square (kg/m\^2) to 32.0 kg/m\^2, inclusive
* All women must have a negative highly sensitive serum (beta-human chorionic gonadotropin \[beta-hCG\]) at screening

Exclusion Criteria:

* Known allergies, hypersensitivity, or intolerance to any biologic medication or excipients of JNJ-67484703
* Has a diagnosed or reported history or current signs or symptoms indicating severe, progressive, or uncontrolled hepatic, renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
* Have other known inflammatory diseases that might confound the evaluations of benefit from JNJ-67484703 therapy
* Have a history of any clinically significant adverse reaction to murine or chimeric proteins, including, but not limited to, allergic reactions
* Have a history of or currently have felty's syndrome
Hormonal Predictors of Oncologic Surgery

An observational trial to determine whether preoperative hormonal status predicts outcomes of oncologic surgery.


Eligibility Criteria:
Inclusion Criteria:

* Undergoing above surgery for cancer

Exclusion Criteria:

* Started hormonal replacement in past two months
Statins for Prevention of Contrast Induced Nephropathy

In this randomized study the investigators wish to explore the role of pre-procedural statin therapy for the prevention of contrast induced nephropathy in patients with moderate-to-severe renal dysfunction, submitted to elective coronary or angioplasty.


Eligibility Criteria:
Inclusion Criteria:

* patients with pre-angiographic estimated creatinine clearance \< 60 ml/min

Exclusion Criteria:

* contrast medium administration within the previous 10 days
* end-stage renal failure requiring dialysis
* refusal to give informed consent
* previous therapy with statin
Effect of Intravitreal Bevacizumab on Focal Edema With Hard Exudates Secondary to Diabetic Retinopathy

Purpose: To evaluate the efficacy of intravitreal bevacizumab (IVB) on focal edema with hard exudates secondary to diabetic retinopathy.

Design: Prospective interventional case series. Participants: Ten eyes of 10 consecutive patients showing focal edema with hard exudates secondary to diabetic retinopathy which are not eligible for focal laser photocoagulation due to central location (\< 500 µm from fovea).


Eligibility Criteria:
Inclusion Criteria:

1. patients of either gender aged \> 18 years
2. patients with type 2 diabetes
3. central macular thickness \> 300 µm on OCT
4. eyes not eligible for focal laser photocoagulation due to the central location of hard exudates (\< 500 µm)
5. an area of retinal thickening less than 2 disc areas in diameter
6. 67% or more of leakage associated with microaneurysms

Exclusion Criteria:

1. eyes with history of laser photocoagulation or pharmacological intervention for DME on study eye
2. eyes with any pharmacologic intervention on fellow eye within 6 months
3. history of ocular diseases other than diabetic retinopathy
4. surgical history other than cataract extraction with intraocular lens implantation
5. panretinal photocoagulation within 3 months of enrollment
6. media opacity
7. any thromboembolic event within 6 months, or evidence of active cardiac ischemia on electrocardiogram (ECG) at time of screening.
Breast Study to Learn More About the Application of Optical Transillumination Measurements to Assess Breast Cancer Risk and to Potentially Detect the Presence of Breast Cancer.

This study aims to evaluate if a light based technique, called Transillumination Breast Spectroscopy (TIBS), can be used to construct a non-invasive breast cancer risk predictor which provides a better odds ratio than mammographic parenchymal density.

In a previous cross sectional study in a group of women without breast cancer and with varying degrees of parenchymal density patterns, a strong association was demonstrated between Transillumination Breast Spectroscopy (TIBS) and x-ray derived mammographic density. From this, we expect that TIBS should also provide a comparable odds ratio (4-6) as mammographic density for breast cancer risk shown in other independent epidemiological studies. It is possible that TIBS may provide complementary information and a higher odds ratio if compared to the incidence of breast cancer. In contrast to mammography derived parenchymal density pattern, no historical TIBS data is available for a retrospective analysis and hence a cross sectional study within a group of screened women is proposed. We hypothesize that TIBS provides physical information about the breast tissue which can be used to construct a breast cancer risk predictor with an odd ratio \> 6.

Eligibility Criteria:
Inclusion Criteria:

* Are in good health and capable of providing consent
* Are willing to come in to the Princess Margaret Hospital for a single visit to meet with a female research assistant

Exclusion Criteria:

* Have had breast augmentation or reduction
* Have a personal history of breast cancer
* Have had a previous bilateral fine needle aspiration or core biopsy
* Have a breast tattoo
Clinical and Endoscopic Pattern in Children Presented With Upper and Lower Gastrointestinal Bleeding Insohag University Hospital

Gastrointestinal bleeding (GIB) is one of the most common conditions in the emergency department. Upper GIB is a major problem that has been decreasing over the past 20 years but still has high mortality rate. GIB usually manifests as hematemesis (vomiting of blood or coffee-ground-like material), melena (black or tarry stools), and hematochezia. UGIB appears as hematemesis in 40%-50%, and as melena or hematochezia in 90%-98%,However, patients with LGIB typically present with hematochezia, but right-sided colonic bleeding or small bowel bleeding may show as melena.

Endoscopy is the standard of care in the diagnosis and treatment of UGIB. It helps to identify the source of bleeding, establish the underlying etiology ,achieve hemostasis and provide prognostic information to predict the risk of rebleeding causes of UGIB are broadly divided into variceal and nonvariceal (peptic ulcer disease, reflux esophagitis, gastroduodenal erosions, tumors, vascular ectasia, etc. EGD is the diagnostic modality of choice for UGIB with more sophisticated investigations such as computed tomographic angiography and capsule endoscopy being rarely indicated where endoscopy is inconclusive .The primary diagnostic test for upper GI bleed workup is endoscopy. Sensitivity of 92 % - 98 % and specificity of 30 % - 100 % is present for endoscopy for the diagnosis of upper GI bleed. Severity scoring system like Rockall's score, helps to identify the patients who are at higher risk for rebleed and mortality.

Lower gastrointestinal ( GI ) haemorrhage is defined as bleeding distal to the ligament of Treitz. Most of the pathological lesions and haemorrhage in the lower GI tract are usually located in the rectum , sigmoid and left sided colon.It is usually suspected when patients complain of haematochezia (passage of frank bright red blood) or bloody diarrhea.Most of the bleeding from the lower GI tract stops spontaneously and patients usually have favorable outcomes compared to upper GI haemorrhage. However, morbidity and mortality tend to increase in older patients and with other pre existing co morbidities.


Eligibility Criteria:
Inclusion Criteria:

* children under 18years old who present with upper and lower gastrointestinal bleeding

Exclusion Criteria:

* bleeding due to systemic causes