cyrilzakka/clinical-trials huggingface dataset:
Prevalence of Temporomandibular Joint Disorders Among Egyptian University Postgraduate Students

The study will take place in Egypt. Postgraduate students from different faculties of the Egyptian Universities will participate. The study will begin in Decemberr 2020.

Matching criteria and allocation ratio The planned study a single arm cross sectional study, in which the prevalence of students of TMD will be reported. The association between TMD and other variables will be also studied. Gender, Age, Psychological stress, non-nutritional oral habits as nail biting, lip biting, object biting and grinding of teeth (bruxism \& clenching), Para-functional habits, such as intensive gum chewing, leaning of the chin on the hand and mouth breathing , previous dental treatment and previous jaw trauma will be all studied.

Data sources and management Data sources, the answered questionnaires and subsequent spread sheets will only be shared by the team members.

ddressing potential sources of bias Selection bias: Sampling will be convenient sampling, Questionnaires will be handed to the students, otherwise an email will be sent to all the students through their university email addresses if COVID-19 situation prevails.

Statistical methods Statistical methods

All confounders, effect modifiers and exposures will be controlled for by crude and adjusted regression analyses, where the primary analysis will be the adjusted one. Failure to do so as a result of violating principles of a regression model will call for a subgroup analysis, where a student t test will be used for the comparison between the subgroups.

It is also planned to study the interactions between the variables via ANOVA test if the data show normal distribution.

Participants with missing data will be excluded.

- Cross-sectional study-Since the planned sampling method is cluster sampling, where the design effect factor becomes greater than 1.

Sensitivity of the results to adjusted and crude analysis will be done.

Eligibility Criteria:
Inclusion Criteria:

1. Postgraduate students in Egyptian universities
2. Age ranges from 18-45 years
3. Males and females

Exclusion Criteria:

-
Multicenter Study to Describe the Performance of the AOS-C2001-B Device in Patients With Colostomy

The study evaluates the efficacy of a new 2-piece appliance in patients with colostomy.


Eligibility Criteria:
Inclusion Criteria:

* Patient is at least 18 years old
* Patient having a colostomy with a diameter less than 30 mm for users of Ø 55 mm pouches or having a colostomy with a diameter less than 40 mm for users of Ø 65 mm pouches
* Patient having a colostomy for at least 1 month
* Patient using a flat ostomy appliance
* Patient having a stoma protusion smaller than or equal to 1.5 cm
* Patient capable to apply and remove the appliance himself or with the help of a caregiver (except health care professional)
* Patient having a mental capacity to participate to the study (i.e. to understand the study and to answer to the questions)
* Patient agreeing to test the new appliance during the evaluation phase (14±3 days)
* Patient covered by social security

Exclusion Criteria:

* Patient experiencing repeated leakages with the usual pouching system
* Patient currently suffering from peristomal skin complications (bleeding or red and broken skin at the time of inclusion)
* Patient receiving or having received, within the last month, chemotherapy, radiotherapy or corticotherapy
* Patient already participating in another clinical study or who have previously participated in this investigation
* Pregnant or breast-feeding woman
Oral Versus Intravenous Rehydration for Prevention of Dehydration in Premature Babies, During the First Days of Life.

This prospective randomised study comparing administration of a hypo-osmolar oral hydration solution with the classical hydration via IV (intravenous) infusion in premature infants of more than 32 weeks GA (gestational age) aims to determine whether administration of a hypo-osmolar oral hydration solution is as efficient as intravenous infusion.

In order to prevent dehydration of the premature infant during the first days of life, enteral nutrition with milk must be complemented by an additional fluid supply, commonly administered intravenously. We propose to perform a prospective randomised multi-centric study comparing administration of a hypo-osmolar oral hydration solution with the classical hydration via IV (intravenous) infusion in premature infants of more than 30 weeks GA (gestational age).

We define success as a weight loss inferior to 15 % of birth weight and a weight at day 15 superior to birth weight. Failure was defined hence as a weight loss superior to 15% of birth weight or a weight at day 15 inferior to birth weight or a severe complication or death. Major violations of the protocol in the study group will be counted as failures. The other objectives were to determine whether oral hydration demonstrates practical advantages: less complications in initial management, more comfort for the baby and less technical challenges for the nurses/doctors in charge. Furthermore to evaluate the clinical tolerance of oral hydration from a nutritional point of view and to examine it's effects on intestinal function (defecation, gastric residues), signs of intestinal inflammation and GI flora.

Eligibility Criteria:
Inclusion Criteria:

* Premature babies between 32 to 34 + 6 weeks of gestation, with a birth weight greater than 1700g and less than 2200g under exclusion of SGA (small for gestational age) babies with a BW \< 10th percentile.
* Infants must be included within the first 12 to 24 hours of life
* Good tolerance to nasogastric milk feeding
* Necessity of additional fluid supply
* Any suspicion of gastro intestinal or metabolic disease
* Maximal humidity in incubator
* Parental consent form

Exclusion Criteria:

* suspicion of gastro-intestinal disease,
* severe digestive risks, and metabolic diseases in the family history,
* metabolic or hydro-electrolyte disorders
* other severe diseases
Intrathecal Tetanus Immunoglobulin to Treat Tetanus

To establish whether the addition of intrathecal tetanus antitoxin reduces the need for mechanical ventilation in patients with tetanus

The investigators will conduct a randomised partially-blinded controlled 2x2 factorial trial. First, adults admitted to the Intensive Care Unit at the Hospital for Tropical Diseases Ho Chi Minh City will be randomized to receive either human (3000 IU) or equine (21,000 units) intramuscular antitoxin. Second, participants will be randomized to receive either standard treatment with intramuscular antitoxin alone or with the addition of 500 IU intrathecal human antitoxin. Patients with prior antitoxin treatment and those with contra-indications to lumbar puncture or antitoxin treatment will be excluded.

All patients will receive other standard tetanus treatment as deemed necessary by the attending physicians. Spasms will be treated with benzodiazepines as first-line therapy. Patients with spasms not controlled with benzodiazepines will receive tracheostomy, paralysis, magnesium sulphate and mechanical ventilation. Heart rate, BP, temperature and daily drug use will be recorded throughout the ICU stay. Patients will be followed following discharge from hospital until 240 days for disability/ death.

Eligibility Criteria:
Inclusion Criteria:

* All adult patients (≥16 years old) with a clinical diagnosis of generalized tetanus admitted to the intensive care unit (ICU) at the Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam

Exclusion Criteria:

* Prior administration of antitoxin during this episode
* Contra-indication to use of human or equine antitoxin
* Contra-indication to lumbar puncture
* Already receiving mechanical ventilation or expected to require this before intrathecal injection can be given
* Pregnancy
* Informed consent not obtained
To Explore the Optimal Dose of Alfentanil for Skull Pin Fixation in Intracranial Surgery

Forty patients were enrolled, and all patients used total intravenous anesthesia (alfentanil-propofol based TIVA) as anesthesia induction and maintenance. According to our experience, patients who underwent intracranial surgery for skull pin fixation used alfentanil 100 ng/ml, while the hemodynamics is relatively stable. Therefore, when this plan is implemented, the patient needs to be under the same depth of anesthesia (monitored by EEG, maintaining a value of 40-60), first start with alfentanil 100 ng/ml, and use the up and down method as adjust 25 ng/ml of concentration of alfentanil each time. An SPI higher than 80 and hyperdynamics (the increased HR and MBP up 20% of baseline or HR\>100bpm and ABP\>180/100mmHg) indicates insufficient analgesia, therefore increase it by 25 ng/ml at the next patient; an SPI lower than 80 and stable hemodynamics (the changes of HR and MBP within 20% of baseline or HR\<50bpm and ABP\<90/50mmHg) indicates that analgesia is acceptable, and the next patient will decrease it by 25 ng/ml during skull pin fixation. If the analgesia is inadequate, increase alfentanil concentration will be prescribed. On the other hand, if analgesia is adequate, however hyperdynamics was noted, beta blocker or calcium channel blocker will be prescribed. If hypotension (ABP\<90/50 mmHg) or bradycardia (HR\<50 bpm) occur, we first stop alfentanil infusion and treated with ephedrine or atropine, respectively.

Data collection: HR, MBP, SPI, BIS, systolic pressure variation (SPV), pulse pressure variation (PPV) , concentrations of propofol and alfentanil before 2 mins, during, 5, and 15 mins of skull pin fixation were recorded and analyzed.


Eligibility Criteria:
Inclusion Criteria:

* Must be at least 18 years old and less than 80 years old
* With anesthesia risk grade below grade three (including grade three) (ASA I\~III)
* Patients who are expected to undergo intracranial surgery for skull pin fixation

Exclusion Criteria:

* Those with anesthesia risk classification ASA class IV or higher
* Those who are allergic to alfentanil or propofol drugs
* Emergency patients
The Fibrin Pad CV Phase III Study

The objective of this study is to evaluate the safety and effectiveness of the EVARREST™ Fibrin Sealant Patch as an adjunct to hemostasis during cardiovascular surgery.


Eligibility Criteria:
Inclusion Criteria:

* Subjects ≥18 years of age, requiring an elective or urgent, open aortic surgical procedure utilizing cardiopulmonary bypass. Subjects in Japan between ≥18 and \<20 years of age will require consent by the subject's legal representative
* Subjects must be willing to participate in the study and provide written informed consent.
* Presence of an appropriate Target Bleeding Site (TBS) along the anastomotic suture line, involving a synthetic aortic graft, as identified intra-operatively by the investigator;

Exclusion Criteria:

* Subjects with known intolerance to blood products or to one of the components of the study product or unwilling to receive blood products;
* Exposure to another investigational drug or device in a clinical trial within 30 days prior to surgery or anticipated in the 60 day follow up period after surgery.
* Female subjects who are pregnant or nursing.
* TBS is from a large defects in visible arteries or veins where the injured vascular wall requires repair and maintenance of vessel patency or where there would be persistent exposure of EVARREST™ Fibrin Sealant Patch to blood flow and/or pressure during absorption of the product;
* TBS with major arterial bleeding requiring suture or mechanical ligation;
* TBS involves an expanded polytetrafluoroethylene (ePTFE) graft
* TBS within an actively infected field;
* Bleeding site is in, around, or in proximity to foramina in bone, or areas of bony confine;
* Subjects with any intra-operative findings identified by the investigator that may preclude conduct of the study procedure;
Real World Data Analysis of PARP Inhibitors Use in Patients With Ovarian Cancer

Real-world clinical outcomes and toxicity data will be evaluated in patients with advanced high grade ovarian cancer who will receive PARP inhibitors.

A prospective-retrospective analysis of patients with histologically confirmed high grade ovarian cancer who will receive or received olaparib or niraparib will be conducted at any line of treatment.

Eligibility Criteria:
Inclusion Criteria:

- women \>18 years old with advanced high grade ovarian cancer

Exclusion Criteria:

-
Effects of Oral Levosimendan on Ambulatory Electrocardiographic Variables

The primary objective is to explore the safety of low doses of oral levosimendan in patients with recent history of an ischaemic cerebrovascular event (stroke or TIA). The main focus will be on the evaluation of proarrhythmic potential of the different dose regimens.

This is a prospective, multicentre, phase II, randomized, double-blind, placebo-controlled 2-arm parallel group study with 5 escalating dose-levels of oral levosimendan, each given for 13-18 days. The study population will be randomly allocated either to the levosimendan group or to the placebo group. The double-blind phase with either placebo or levosimendan is preceded by a 13-day long single-blind treatment with placebo (placebo run-in). The study consists of 9 visits (screening visit, 7 visits during the treatment period and an end-of-study visit). Each subject will be on study treatment (including placebo run-in) for 78-108 days and the duration of the study for each subject, including the screening and the end of study visit, is approximately 17 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients 50 to 80 years of age with ischaemic stroke or TIA within 1 to 9 months before the screening visit.

Exclusion Criteria:

* Stroke or TIA due to cardiac embolism, vasculitis or arterial dissection
* Severe hemiparesis or dysphasia, haemodynamically significant uncorrected valve disease or hypertrophic cardiomyopathy or restrictive cardiomyopathy, any acute coronary event or angioplasty or any other major surgery within 1 month, any major surgery during the planned study period
* History of life-threatening ventricular arrhythmia within 3 months.
* History of Torsades de Pointes (TdP) or family history of long QT-syndrome
* Heart rate (HR) \< 50 or \> 100 bpm.
* Systolic blood pressure (SBP) \< 100 mmHg or \> 180 mmHg, or diastolic blood pressure (DBP) \> 100 mmHg.
* Ventricular tachycardia.
* Episode of atrial fibrillation or atrial flutter lasting \> 60 seconds.
* Second or third degree atrioventricular (AV) block.
* Potassium (K) \< 3.7 mmol/l or \> 5.5 mmol/l.
* Creatinine \> 170 µmol/l or on dialysis.
* Blood haemoglobin \<10 g/dl; clinically significant hepatic impairment.
Influence of Preload Dependence on the Effect of Phenylephrine on Cardiac Output

The perioperative hemodynamic management aims to ensure organ perfusion pressure and an oxygen arterial transport adapted to oxygen consumption. Phenylephrine is the α-adrenergic agonist widely used during anesthesia for arterial pressure control.

Several questions on phenylephrine global and regional hemodynamics effects remain unresolved.

The investigators assume that Phenylephrine may decrease cardiac output by increasing the afterload, while most likely could also make an increase or a stability of cardiac output by action on the venous return. The investigators propose an observational study assessing the influence of preload dependence, defined by the values of pulse pressure variation, on the effect of phenylephrine on cardiac output, measured beat by beat by esophageal Doppler.

The aim of the investigators work is to improve the understanding of phenylephrine action, a daily use therapeutic action, to improve the patients care.


Eligibility Criteria:
Inclusion Criteria:

* Hypotension (SBP \<90 mm Hg and / or MAP \<60 mm Hg)
* Injection of a bolus of phenylephrine at the discretion of the anesthesiologist physician in charge of the patient.

Exclusion Criteria:

* Minor or major patient under guardianship
* Esophageal Diseases
* supra ventricular rhythm trouble
* Severe valvular
* Shunt intracardiac
* Vt \<7ml/kg theoretical weight
* heart rate / respiratory rate \<3.6
* Clinical hypepression of intra-abdominal
* Compliance \<30 mL/cmH2O
* pulmonary hypertension, Right ventricular failure
* Spontaneous Ventilation
* Thorax open
* VG severe dysfunction (LVEF \<40%)
* Prior Injection of ephedrine prior
Right Ventricular Contractile Reserve in HF

Right ventricle dysfunction and pulmonary hypertension are related to a worse prognosis in patients with heart failure with reduced left ventricular ejection fraction (HFrEF) or with normal left ventricular ejection fraction (HFpEF).

There is preliminary evidence however, that the responses of the right ventricle and of the pulmonary hemodynamics to stress tests (especially physical stress) may allow to prognostically stratify these patients, as these responses may bring out latent right ventricle dysfunction or a normal contractile reserve in patients with dysfunction at rest.

In view of the different pathophysiological mechanisms of the left ventricular dysfunction in HFpEF and in HFrEF, also the response and the adaptation of the righty ventricle to stress tests may be different in these two groups of patients.

In this preliminary two groups of 20 patients with HFpEF and HFrEF will be subjected to to simple stress tests: passive leg raising and inotropic stimulus with dobutamine.

This study intends to analyze, through colorDoppler echocardiography, the behaviour of the right ventricle and the pulmonary circulation during passive leg raining and infusion of dobutamine, in a cohort of patients with HFrEF or HFpEF.

The analysis will be focused on the relation between echocardiographic parameters, especially those concerning right ventricular function and pulmonary hemodynamics, thereby comparing the responses observed in HFrEF vs HFpEF.

Furthermore, correlations between the above-mentioned echocardiographic parameters and parameters of daily clinical practice will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* heart failure with reduced (EF ≤40%) or preserved (EF \> 50%) ejection fraction
* echocardiographic acoustic window adequate for evaluation of outcome parameters
* presence of tricuspid insufficiency which allows assessment of pulmonary artery systolic pressure

Exclusion Criteria:

* recent myocardial infraction (\<3 months) or unstable angina
* moderate o severe aortic or mitralic valve disease
* inadequate acoustic window
* significant anemia (hemoglobin \<10 g/dl)
* recent heart surgery (\< 3 months).
L-carnitine in Modulating Pain and Inflammation in Rheumatoid Arthritis

This study aims at evaluating the possible efficacy and safety of L-carnitine in rheumatoid arthritis via targeting Jak/STAT pathway and TGF-β1


Eligibility Criteria:
Inclusion Criteria:

* Patients with active rheumatoid arthritis (not in remission) according to American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) 2010 criteria (9) i.e., 28 joints disease activity score (DAS-28) \>2.6.
* Patients receive the conventional DMARDs
* Both sexes.
* Age range between 18 and 70 years old.

Exclusion Criteria:

* Patients with heart disease (congestive heart failure, arrhythmia, hypertension, ischemic heart diseases), diabetes, active infection, other illness except rheumatoid arthritis.
* Patients with renal and hepatic dysfunction.
* Patients receiving biological DMARDs.
* Patients receiving oral prednisolone greater than 15 mg/day.
* Patients with hypersensitivity to study medications.
* Patients using antioxidants.
* Pregnant and lactating females.
Addressing Hypertension Care in Africa

A pilot cluster randomized control trial to test the feasibility of a multilevel, nurse-led, mobile health enhanced intervention in patients with uncontrolled hypertension in Ghana

This is a two-arm pilot cluster randomized controlled trial (RCT) involving 240 participants with uncontrolled hypertension (HTN) with the healthcare setting as the unit of randomization and patients as the unit of analysis. Each of the four healthcare settings will be recruited and randomly assigned to the multilevel intervention or control group. A statistician will generate the randomization using a computer-generated random sequence program with an allocation ratio of 1:1 and a block size of 6 (to assure equal numbers in each arm). After having met study criteria for enrollment, 60 eligible patients for each setting will be assigned to either control or intervention arm according to the patients' healthcare setting's intervention assignment by the study coordinator. A cluster RCT has been chosen to avoid potential treatment contamination in which physicians within healthcare settings might unintentionally provide patients with different degrees of attention or blending of treatment protocols. The intervention will be administered for six months following which it will be withdrawn, and patients will be followed for six more months to assess outcomes.

The investigators will use quota sampling to over sample socioeconomically deprived persons to ensure that socioeconomically deprived persons comprise 50% of the sample. Poverty will be defined by (1) Household income, based on Ghana minimum monthly wage of 210 Ghana cedis (equivalent of $55). After screening eligible participants, the investigators will assign four clusters of 60 patients to the intervention or control arms. The investigators will require 30 patients in each cluster to be male and 30 to be female since in the investigators' previous work, men have been underrepresented potentially due to gender-differences in healthcare seeking behaviors. Men have also had inferior treatment and control rates in previous studies.

Eligibility Criteria:
Inclusion Criteria:

* Patients will be included if they are 18-70 years old;
* Male or female
* Uncontrolled hypertension (SBP ≥140 mm Hg) based upon last outpatient encounter within the previous three months
* Patients with previous strokes, coronary artery disease, up to stage three kidney disease and diabetes mellitus meeting BP cut-off criteria will be eligible for enrollment.

Exclusion Criteria:

* Patients will be excluded if they fail to meet any of the above inclusion criteria
* Severe cognitive impairment/dementia (Modified Mini-Mental State Examination (MMSE) score ≤24)
* Severe global disability (modified Rankin Scale (mRS) score ≥3)
* Not able to independently follow blood pressure measurement protocol or use of Smartphone for study protocol or without a care-giver to assist with BP monitoring at home
* Patients with estimated glomerular filtration rate (eGFR) \<30ml/min
PRICE Survey Of Extubation Following Infratentorial Craniotomy

The PRICE study primarily aims to identify predictors of early extubation following elective infratentorial craniotomy in adults. It also aims to (i) measure the rate of early extubation in different clinical settings; and (ii) study how the decision to extubate early is made and communicated in clinical practice. The first phase of the study (PRICE1) is a brief online survey addressed to physicians in charge of neurosurgical patients (neuroanesthesiologists, neurosurgeons, neurocritical care specialists) in multiple countries.


Eligibility Criteria:
Inclusion Criteria:

* Physician actively involved in delivering care to neurosurgical patients
* Physician formerly involved in delivering care to neurosurgical patients

Exclusion Criteria:

* Has already completed the survey