cyrilzakka/clinical-trials huggingface dataset:
Effect of a Medical Food Supplement in Hospitalized Patients Recovering From Surgery

The objective of this study is to evaluate the effect of nutritional supplementation on the nutritional and clinical course of patients admitted to the hospital for hip fracture surgery.


Eligibility Criteria:
Inclusion Criteria:

* Subject is \> 45 years of age.
* Subject is a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum prior to screening visit.
* Subject plans to undergo hip fracture surgery.
* Subject has anticipated length of hospital stay of at least 4 weeks. Subject is able to consume foods and beverages orally.
* Subject has admission total protein ≤ 70 g/L.
* Subject has screening serum albumin ≤ 38 g/L.

Exclusion Criteria:

* Subject is known to be allergic or intolerant to any ingredient found in the study product.
* Subject has pre-planned surgery other than hip fracture surgery during the study period.
* Subject has alcohol or substance abuse, severe dementia, brain metastases, eating disorders or any psychological condition that may interfere with dietary intake, severe nausea, vomiting, diarrhea, active gastritis, gastrointestinal bleeding or other gastrointestinal disturbances.
* Subject has active malignancy
* Subject has chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
* Subject has diagnosis of IDDM.
* Subject has uncontrolled NIDDM determined by HbA1c \> 8%.
Cytogenetic Analysis of Bone Marrow Specimen Prior to High Dose Chemotherapy and Autologous Stem Cell Transplantation in Patients With Non-Hodgkin's Lymphoma or Hodgkin's Disease

Cytogenetic Analysis of Bone Marrow Specimen Prior to High Dose Chemotherapy and Autologous Stem Cell Transplantation in Patients with Non-Hodgkin's Lymphoma or Hodgkin's Disease


Eligibility Criteria:
Inclusion Criteria:

* Patients with Non-Hodgkin's Lymphoma or Hodgkin's Disease
Effectiveness of an HIV-adapted IMCI Training and Supervision Programme for Community Health Workers

This is a cluster randomized controlled trial (C-RCT) to evaluate the effectiveness of a Community-Integrated Management of Childhood Illness (C-IMCI) training for community caregivers (CCGs), adapted to include HIV-related interventions, on the delivery of maternal, newborn and child health interventions within households in rural communities in Ugu District, KwaZulu-Natal (KZN) Province, South Africa. The intervention includes two components: (1) a 2-week HIV/C-IMCI training for CCGs and their associated facilitators and supervisors, and (2) continuous support and supervision following the continuous quality improvement (CQI) framework, a low-technology approach to management and supervision of health programs. The primary objectives of the proposed evaluation are to measure the effect of the intervention on key outcomes, including early uptake of antenatal care, facility based delivery, postnatal visits, coverage of exclusive breastfeeding, and uptake of HIV PCR testing in infants at 6 weeks. We will also examine the effects of the intervention on immunization uptake up to 12 months and knowledge and practices of CCGs and mothers pertaining to maternal, newborn and child health.


Eligibility Criteria:
Inclusion Criteria:

Community caregivers

* CCGs who work in Ugu District
* age 18 years or older
* with grade 9 education or greater

Mothers

* Mothers age 18 years and older who delivered a live-born infant within the prior 12 months
* Reside in households served by participating CCGs.

Exclusion Criteria:

* None
Clinical Assessment Method in Patients Using Non-invasive Ventilation

This is an observational study of recording the respiratory parameters of patients when receiving non-invasive ventilation and analyze the relationship between those parameters and clinical outcomes.

Non-invasive positive pressure ventilation (NPPV) is undoubtedly one of the most important advances in mechanical ventilation technology in the past 30 years. Currently, NPPV has become an essential respiratory support technology in hospitals, and it is used in different fields, including respiratory and critical care, emergency care, anesthesia, and rehabilitation. Applications of NPPV are also gradually expanding from intensive care units (ICUs) and respiratory wards to use in other medical departments and at home.

This is an observational study of recording the respiratory parameters of patients when receiving non-invasive ventilation and analyze the relationship between those parameters and clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-80, males and females
2. Patients with hypercapnic respiratory failure
3. Willing to participate in the study.
4. Being able to provide informed consent.

Exclusion Criteria:

1. Subjects with severe heart failure, severe arrhythmias, unstable angina, and malignant comorbidities.
2. Subjects with significantly impaired cognitive function and are unable to fulfill the study requirement (unable to provide informed consent)
3. Subjects who participated in another trial within 30 days prior to the planned start of the study
Thoracic Fluid Content and Acute Lung Injury

To study the association of the thoracic fluid content and acute lung injury during liver transplantation.

Acute lung injury is not uncommon after liver transplantation. A new monitor non-invasive cardiac output monitor (NICOM) is designed to measure thoracic fluid content. The investigators attempt to use the parameter thoracic fluid content to investigate its relationship with acute lung injury in liver transplant recipients.

Eligibility Criteria:
Inclusion Criteria:

* end stage liver disease scheduled for liver transplantation in National Taiwna University Hospital.

Exclusion Criteria:

* allergic reaction
* history of aortic regurgitation
* pre-existing pulmonary disease
Structured Data Collection of Patients Undergoing Liver Transplantation and Evaluated for Bone Mineral Metabolism

Observational cohort study offered consecutively to every liver transplant patient who arrives for the first endocrinology visit or returns for follow-up visit for bone metabolism assessment.

The retrospective and prospective single-center observational cohort study will be offered consecutively to every liver transplant patient who arrives for the first endocrinology visit or returns for follow-up visit for bone metabolism assessment at UO Endocrinology of Policlinico S. Orsola-Malpighi.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Patients undergoing liver transplantation for any cause.
* Performance of bone densitometry
* Performance of examinations pertaining to mineral metabolism
* Obtaining informed consent

Exclusion Criteria:

* none
Wearable Devices to Promote Physical Activity

This study evaluates the effect of a new wearable device, that measures physical activity level based on heart rates, on relevant health outcomes including cardiorespiratory fitness. Half of participants will be instructed in using the Mio Slice wristband, while the other half will be requested to follow today's recommendations for physical activity.

Two critical challenges precluding the full potential of physical activity in preventive healthcare are: 1) The majority of people are not sufficiently active, and 2) there is a lack of large, long-term intervention studies documenting the effect of personalized activity and improved health in the population. Using HUNT data an algorithm called Personal Activity Intelligence (PAI) has been developed. PAI was integrated in a smartphone application and user friendly wristband (Mio Slice), that measures heart rate continuously and estimates an individual threshold for total physical activity (defined as 100 weekly PAI) that is associated with reduced risk of cardiovascular disease and mortality. The primary aim of the study is to reveal whether using the wristband will increase cardiorespiratory fitness, determined by maximal oxygen uptake, after 4 months among low-fit participants. The secondary aims includes the effect on reversing cardiovascular risk factors, cardiac structure and function, adherence to physical activity and identification of barriers after 16 weeks and 1 year.

Eligibility Criteria:
Inclusion Criteria:

* Participated in HUNT 3 and HUNT 4 Fitness Study
* VO2peak in HUNT4 in the lowest sex- and age-specific tertile.

Exclusion Criteria:

* Illness or disabilities that preclude completion of the study or make exercise contraindicated
* uncontrolled hypertension, arrhythmias or angina
* heart failure
* primary pulmonary hypertension
* diagnosed dementia
* chronic communicable infectious diseases
* participation in conflicting interventions
Nutrition in Pregnancy, Birth Weight, and Childhood Asthma

To evaluate the role of maternal diet and birth weight in the etiology of childhood asthma and other allergic disorders.

BACKGROUND:

Asthma is one of the most common chronic diseases diagnosed among children in the developed world, and its prevalence in western industrialized countries is increasing at an alarming rate. Little information is currently available regarding the role of maternal diet during pregnancy and birth weight in the risk of childhood asthma.

DESIGN NARRATIVE:

This longitudinal prospective study takes advantage of the resources provided by Project Viva, an ongoing prospective cohort study of pregnant women and their infant offspring among members of Harvard Pilgrim Health Care, a large managed care organization in New England. Data already available from Project Viva include detailed dietary data on mother and infant, along with data on anthropometric, social, environmental, demographic, economic, psychological, and lifestyle variables. The study will follow the Project Viva cohort until ages 3 to 4 years.

Eligibility Criteria:
No eligibility criteria
"ORBIT" Versus "HAS-BLED" Scores in Predicting Major Bleeding in Patients With Atrial Fibrillation Receiving Oral Anticoagulants.

Atrial fibrillation (AF) is type of arrhythmia characterized by an irregular and often rapid heartbeats, it has strong associations with other cardiovascular diseases, such as heart failure, coronary artery disease (CAD), valvular heart disease, diabetes mellitus, thyrotoxicosis and hypertension.

Atrial fibrillation is the most frequent cardiac arrhythmia. It has been estimated that 6-12 million people worldwide will suffer this condition in the US by 2050 and 17.9 million people in Europe by 2060. Atrial fibrillation is a major risk factor for ischemic stroke and provokes important economic burden along with significant morbidity and mortality .

(AF) is arrhythmia with the potential to cause thromboembolism. Studies suggest that AF increases the risk of stroke five-folds. Stroke prevention is central to the management of patients with atrial fibrillation (AF), and effective stroke prevention requires oral anticoagulation (OAC). Either a vitamin K antagonist (VKA; e.g. warfarin) or a non-VKA oral anticoagulant (NOAC) .

It's essential reach the balance between prevention of thromboembolic as well as bleeding events during the anticoagulant use.


Eligibility Criteria:
Inclusion Criteria:

* All patients with atrial fibrillation :

  1. Aged 18 years old or older .
  2. Underwent cardiac valve replacement
  3. Who have valvular heart disease receiving anticoagulants .
  4. Who have non valvular AF in whom CHA2DS 2VASc score 2 or more.
  5. Receiving either vitamin K antagonist e.g warfarin or NOAC .

Exclusion Criteria:

1. Patients age less than 18 years old
2. Patients receiving anticoagulants without atrial fibrillations
3. Pregnant patients with AF
4. Patients with AF on Non oral anticoagulants
Pharmacokinetic Evaluation of Intranasal Nalmefene

This study is to determine the pharmacokinetics (how the body absorbs, breaks down and eliminates drug from your body) of nalmefene when given intranasally (IN;into the nose) compared to a dose of nalmefene when given intramuscularly (IM; into the muscle); to compare the blood levels of nalmefene when given IN to nalmefene when given IM; and to evaluate the safety and tolerability of nalmefene IN.

Open-label, randomized, 2-period, 2-treatment, 2-sequence, crossover study in 68 healthy volunteers. Subjects will be assigned to each of the 2 possible sequences. Each subject will receive 2 treatments during the 2 dosing periods: Intranasal (IN) dose of 3 mg nalmefene hydrochloride and intramuscular (IM) dose of 1.0 mg nalmefene, with a 4 day washout period between doses. Screening can occur up to 28 days before baseline admission, subjects will then stay in the inpatient facility for 7 days to complete the treatment phase of the study and will be discharged following completion of the discharge procedures at the end of the last period. Subjects will be called 3 to 5 days after discharge to inquire concerning Adverse Events (AEs) and concomitant medications since discharge.

Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18 to 55 years inclusive
* BMI ranging from 18 to 30 kg/m2, inclusive
* Adequate venous access
* Subjects must be non-smokers

Exclusion Criteria:

* History of clinically significant disease
* Significant trauma injury, major surgery, open biopsy within 30 days prior to screening
* Following an abnormal diet 4 weeks prior to screening
* Use of over the counter medications, dietary supplements, herbal products, vitamins or opioid analgesics 14 days before intervention
* Use of enzyme altering drugs 30 days before intervention
* Use of nasal products 28 days before intervention and throughout the study
* Previous or current opioid, alcohol, or other drug dependence
* Donated or received blood 30 days before intervention
* Women who are pregnant or breastfeeding at screening
* Women of childbearing potential unless surgically sterile or use effective contraception
* Current or recent upper respiratory tract infection
* Allergic to nalmefene
Comparison of the Classic Face Mask Versus NuMask for Preoxygenation

Currently used face mask has certain disadvantages; such as, not providing a complete seal in certain patients, causing hand fatigue after holding the mask in place for more than a few minutes, causing claustrophobia in an occasional patient, the need to hold the mask from head of the bed, and possible worsening of the trauma in patients with facial injuries, and the need to use different size masks in different patients. The NuMask overcomes all of these disadvantages and does benefit the patients.

The administration of oxygen before anesthetic induction and tracheal intubation (preoxygenation) is a well-recognized technique designed to increase oxygen reserves and thereby delay the onset of arterial oxygen desaturation during apnea. It is particularly important if manual ventilation is not desirable prior to intubation (eg: rapid sequence induction) or if difficulty with ventilation or intubation is anticipated or in patients with oxygen transport limitations. Because the "cannot ventilate/cannot intubate" situation is an unpredictable event, theoretically all patients should be maximally preoxygenated.

Fraction of inspired oxygen (FIO2) is one of the factors in achieving maximal preoxygenation. A common reason for the failure to achieve an FIO2 close to 1.0 is a leak under the face mask. Several factors may contribute to the leak. These are edentulous patients, patients with sunken cheeks, bearded patients, the presence of nasogastric tubes, wrong size face masks, improper use of head straps, and patients with large heads and faces where even the large size mask may not fit properly.

Recently a new intraoral mask "NuMask" has become available for anesthetic induction. It is placed under the lips and outside the gums of the patient mouth (similar to snorkel mouth piece), thus providing a good seal in almost any patient. In addition to providing a good seal, the NuMask has other advantages over the standard face mask. It has very small dead space (18 cc : 110 cc), provides comfortable grip, ventilation can be provided from any position and causes less facial trauma.

The efficacy of preoxygenation using the NuMask will be compared to the classic face mask in approximately 30 healthy and consenting adult volunteers. All of the volunteers will be randomly assigned into one of 2 groups. All volunteers will be tested for three (3) periods of 5 minute intervals. Inspired oxygen (FIO2), end-tidal oxygen (ETO2), end-tidal carbon dioxide (ETCO2) and respiratory rate (RR) will be tested. Analysis of the data may reveal whether the NuMask is equal, superior, or inferior to the classic face mask in achieving maximal preoxygenation.

Although the NuMask has been tested and used in various scenarios of airway management, its efficacy in achieving maximal preoxygenation has not been studied

Eligibility Criteria:
Inclusion Criteria:

* volunteers

Exclusion Criteria:

* under 18
Budesonide Multimatrix(MMX) Versus Prednisolone in Management of Mild to Moderate Ulcerative Colitis

My study aims to directly compare the efficacy and safety of Budesonide MMX versus Prednisolone in the management of mild to moderate cases of ulcerative colitis.

It is a randomized clinical trial where patients with mild to moderate ulcerative colitis who failed to respond to conventional therapy with mesalazine will randomly be divided into two groups one of them will be given prednisone and the other will be given budesonide MMX.

The efficacy of Budesonide MMX and Prednisolone will be measured by the rate of clinical, laboratory, endoscopic, and histological improvement 8 weeks after randomization. Clinical assessment (the rate of bowel movements and rectal bleeding) and laboratory investigations ( complete blood count \[CBC\], C reactive protein\[CRP\], and fecal calprotectin) will be done after 4 and 8 weeks from treatment initiation. Endoscopic and histological assessments will be done at week 8.

Eligibility Criteria:
Inclusion Criteria:

* This study will include patients with confirmed mild to moderate ulcerative colitis according to the Mayo score activity index with ages ranging between 18-60 years old.

Exclusion Criteria:

* Patients \< 18 years old.

  * Pregnant females.
  * Patients with proven infection with any enteric pathogens (e.g., Shigella species, Clostridium species, Salmonella species, ova, parasites, Clostridium difficile toxins A or B, or HIV infection).
  * Patients who received oral or rectal steroids in the last 4 weeks, immunosuppressive agents in the last 8 weeks, or anti-tumor necrosis factor agents in the last 3 months.
  * Patients with severe colitis (Mayo score \>11); Patients with evidence or history of toxic megacolon.
  * Severe anemia (hemoglobin \<10.5 g/dl), leucopenia, or granulocytopenia.
  * Patients using any cytochrome P450 inducers or inhibitors (e.g., ketoconazole, phenytoin) or antibiotics.
  * Patients with renal disease/insufficiency.
  * Patients with type I diabetes.
  * Patients with glaucoma.
  * Patients with malignancies.
  * Patients with decompensated liver cirrhosis (Child-Pugh score B and C).
  * Patients with COVID 19 infection.
Initiation of Airway Code: the Role of the Airway Team in Unexpected Difficult Airways

The aim of our study is to observationally examine our unexpected difficult airway incidence and intervention times. In addition, it is aimed to discuss the clinical effect of a team specialized in airway intervention intervening in cases by call on the success of airway intervention. In this discussion, it is aimed to use the opinion-opposition method.

Initiation of Airway Code: The Role of the Airway Team in Unexpected Difficult Airways

The incidence of difficult airway is approximately 1 in 1000 cases and poses a significant perioperative risk to patients. Various classifications, guidelines, and approaches have been developed to identify patients with difficult airways. However, even the most well-known classifications are not 100% successful in predicting difficult airways. Consequently, some unexpected difficult airway cases are encountered, and their management continues to be a subject of new research in the literature.

In situations involving difficult airways, having the same team respond to every case may pose a potential obstacle to the distribution of experience and responsibilities among other clinical staff. However, it is undeniable that experienced anesthetists are more successful in airway management, and the importance of airway-related training cannot be overstated. Similar to the code blue protocol used during cardiac arrests, the intervention of a trained external team in crisis situations, utilizing familiar equipment and applying data from previous cases for quality improvement, can provide significant benefits in airway management akin to those seen in cardiac arrests. This approach could also potentially enhance patient safety in internal medicine and surgical wards, as well as in certain intensive care units, where familiarity with airway management is limited.

This study aims to discuss the positive and negative impacts of the airway teams intervention in unexpected difficult airway situations within the operating room, using a pro-con debate method.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who will be operated under general anesthesia at Kocaeli City Hospital or who require perioperative endotracheal intubation will be included in our study.
2. Operations performed within the study time period will be taken
3. Patients whose anesthesiologists call for help for difficult airway will be included in the study.
4. Patients between the ages of 18-65 will be included in the study.

Exclusion Criteria:

- 1. Expected difficult airway patients (mallampati 3-4) and other patients with high difficult airway scores will not be included in the study.

2. Patients with difficult airway conditions but who will be awakened by giving up endotracheal intubation will not be included in the study.
A Controlled Study to Evaluate the Efficacy of Allogeneic MesenCure for the Treatment of Patients With ARDS

The efficacy of the allogeneic cell-therapy product MesenCure in addition to standard of care will be evaluated in comparison to placebo control in 300 moderate to severe Covid patients


Eligibility Criteria:
Inclusion Criteria:

1. Patients are able and agree to sign informed consent form before any study-specific procedure.
2. Males or females, age range 18-80.
3. Documented ARDS
4. RA-O2 Saturation of ≤93% and/or Evidence of COVID19-related pulmonary infiltrates on chest X-ray/thoracic tomography
5. Stable hemodynamic condition (blood pressure of systolic \<180mm Hg and diastolic \<110mm Hg)

Exclusion Criteria:

General:

1. Pregnant or breast-feeding females.
2. History of drug abuse.
3. Heavy smokers (above 2 packages a day).
4. Subjects incapable of giving consent.

Background medical conditions:

1. Known history of any significant medical disorder, which in the investigator's judgment contraindicates the subject's participation.
2. History of advanced congestive heart failure or active acute myocardial infarction (AMI), renal failure (estimated GFR of \<30 ml/min/1.73 m2 at screening), or hepatic disease (hepatic insufficiency classified as Child-Pugh B or C).
3. Known autoimmune diseases.
4. Received any investigational drug within 30 days prior to screening day (Visit 1) (Remdesivir is not considered investigational, and is not an exclusion criteria).
5. Immunocompromised condition from any reason, at screening.
6. Abnormal clinically significant laboratory test findings, as per the investigator's judgment.
7. Poorly controlled diabetic subjects (HbA1c \> 9%).
8. Known active lung malignancy.

Concomitant treatment:

1. Currently treated with Immunosuppressive agents other than corticosteroids used for treating COVID19.
2. Treatment for cancer (i.e. chemotherapy or radiotherapy treatment) within the last 12 months.

Hypersensitivity:

1. Known history of hypersensitivity to Dextran-40.
2. Known history of hypersensitivity to Human Serum Albumin.