cyrilzakka/clinical-trials huggingface dataset:
A Dose Finding and Safety Study of Oral LEQ506 in Patients With Advanced Solid Tumors

This first-in-human dose-escalation study is to characterize the safety, tolerability, pharmacokinetics and pharmacodynamics of LEQ506 given orally on a daily dosing schedule in patients with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of advanced solid tumor, recurrent or refractory medulloblastoma or locally advanced or metastatic basal cell carcinoma)
* Protocol defined laboratory parameters
* Performance status ≤ 2
* Patients must have fully recovered from the prior effects of major surgery and from any acute toxicities of prior chemotherapy/radiotherapy

Exclusion Criteria:

* History of central nervous system tumors of symptomatic brain metastases (excludes medulloblastoma patients)
* Impairment of gastrointestinal function or unresolved nausea, vomiting or diarrhea
* Impairment of cardiac function or significant cardiac disease
* Pregnant or lactating women
* Other protocol-defined inclusion/exclusion criteria may apply
Intrauterine Saline Washing for Detection Endometrial Disease in Patients With Abnormal Uterine Bleeding

Investigator will examined the diagnostic effect of the endometrial washing by saline. Because this technique more less painful and easier compared to endometrial curettage. Participants will separate into two groups. In study groups before endometrial curettage 5 cc saline infused to the endometrial cavity then aspirate and put into thin prep to examined. After this procedure routine endometrial curettage will be done. In control group only endometrial curettage will be done. Pathologic results of thin prep and curettage will compared.


Eligibility Criteria:
Inclusion Criteria:

* Abnormal uterine bleeding

Exclusion Criteria:

* Involuntary, under 35 years old,
Transcutaneous Electrical Nerve Stimulation for Pain Relief During the Active Phase of Labor

The objective of this research is to evaluate the effectiveness of Transcutaneous Electrical Nerve Stimulation (TENS) for pain relief in the early active phase of labor. The research will be of type randomized controlled trial, consisting of low-risk nulliparous pregnant women admitted to the Reference Center for Women's Health in Ribeirão Preto. Mothers will be divided into two groups (the use of lumbosacral TENS) and control (routine maternity) and will be evaluated before and after therapy, which corresponds to 30 minutes between 4-5 cm of cervical dilation. The evaluation will be performed by numerical category scale, location and Pain Diagram McGll Pain Questionnaire (short form). After the delivery will be a questionnaire of customer satisfaction.

Pain in the work appears as a subjective experience of interaction, involving a wide individual influences physiological, psychosocial and environmental factors, representing a major clinical signs of this phase. Despite presenting an important biological function, is now well established the need for their relief, since its persistence is associated with detrimental effects for both mother and fetus. Among non-pharmacological resources available, the investigators highlight the massage therapy that has shown positive effects in relieving pain and promote comfort of the mother. The objective of this research is to evaluate the efficacy of Transcutaneous Electrical Nerve Stimulation (TENS) for pain relief in the early active phase of labor. The research will be of type randomized controlled trial, consisting of low-risk nulliparous pregnant women admitted to the Reference Center for Women's Health in Ribeirão Preto. Mothers will be divided into two groups (lumbosacral massage) and control (routine maternity) and will be evaluated before and after therapy, which corresponds to 30 minutes between 4-5 cm of cervical dilation. The evaluation will be performed by numerical category scale, location and Pain Diagram McGll Pain Questionnaire (short form). After the delivery will be a questionnaire of customer satisfaction. After collecting the data, the groups are statistically analyzed using the linear regression model with mixed effects (fixed and random), taking into account a value of p \<0.05 for statistical significance of 5%.

Eligibility Criteria:
Inclusion Criteria:

* primigravida
* literate
* A single fetus in vertex position
* Low-risk Pregnancy
* From 37 weeks of gestation
* Cervical dilatation between 4 and 5 cm with uterine dynamics normal for this stage
* Labor in early spontaneous
* No use of medications during the study period
* Absence of cognitive or psychiatric problems
* Intact membranes
* No risk factors associated
* Who wish to participate and signed the informed consent

Exclusion Criteria:

* TENS procedure intolerance
* Use of any medication or procedure that promotes pain relief
* Use of pacemaker
HUmira in Psoriatic Arthritis

Psoriatic arthritis (PsA) is an inflammatory arthritis associated with psoriasis, which has a estimated prevalence of 0.3 - 1 %. The clinical course varies, but PsA is often a progressive, erosive arthritis causing severe disability and increased mortality.

The biologic treatment infliximab and etanercept have recently been introduced for treatment of PsA and psoriasis, and current data indicate a higher efficacy than with previously available therapies. No clinical trials on adalimumab in PsA are yet published (2005), but preliminary data are encouraging. The improved treatment options have increased the need for sensitive methods for diagnosis, monitoring and prognostication of PsA, so that the efficient therapies can be initiated at the optimal time point and monitored optimally. Ultrasonography (US) and magnetic resonance imaging (MRI) and a number of biomarkers are promising, but not yet sufficiently studied, methods for this.

The hypothesis is that adalimumab will be an effective treatment option for PsA. Novel imaging- and biomarkers can provide additional information, compared to clinical measures and radiography, concerning activity, destructive progression and prediction of therapeutic response in PsA patients receiving adalimumab. The perspective is a potential improvement in diagnosis, monitoring and prognostication of patients with PsA.


Eligibility Criteria:
Inclusion Criteria:

Subject Population: patients with active PsA, fulfilling the following major criteria:

1. Diagnosis of PsA according to Moll and Wright criteria (Moll and Wright,
2. Clinical active disease, defined as \>2 (of 76) swollen joints and \> 2 (of 78) tender joints
3. Involvement of the hands (Clinical swelling of 1 or more finger joint and/or 1 or more 1 sausage finger)
4. Clinical indication for anti-TNF alpha therapy, according to treating physician
5. Among other issues: Age \>18 years; adequate birth control; no contraindications for anti-TNF alpha-therapy, no previous anti-TNF alpha-therapy, no other significant dermatological disorders than psoriasis.
Shorten the Time Required to Correct the Arrival of Complete Oral Feeding in Premature Infants

Non-nutritive sucking combined with a step-by-step oral feeding regimen shortens the total oral feeding cycle in premature infants

In order to improve the feeding of premature infants \<32 weeks of gestation, a complete oral feeding intervention program is provided for premature infants, which combined the evaluation of oral feeding readiness, the evaluation of oral feeding performance, non-nutritional sucking intervention and progressive feeding program. Premature infants will be assessed 12 times a day before feedings using the Feeding Preparation Scale.

Assess the premature infants by using the Feeding Preparation Scale. If the premature infant does not meet the oral feeding standard, let the premature infant use the non-nutritive sucking for 3 minutes before the nasal feeding; if the premature infant meets the oral feeding standard, use the non-nutritive sucking for 3 minutes, and refer to the feeding schedule for the premature infant. The whole intervention stops until the premature infant achieves the full oral feeding. Length of time required for complete oral feeding of premature infants is compared between the intervention group and the control group to evaluate the effect of the complete oral feeding intervention program on improving the feeding of premature infants \<32 weeks of gestation.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age \<32w;
* Admit within 72 hours of birth;
* The guardian signs the informed consent;
* OI (oxygenation index \>300)

Exclusion Criteria:

* Newborns with severe congenital malformations or various chromosomal diseases, genetic metabolic diseases, severe neurological diseases;
* Newborns who die during the study;
* Newborns who drop out of the study;
* Newborns who have NEC during hospitalization
Surgery for Mesothelioma After Radiation Therapy "SMART" for Resectable Malignant Pleural Mesothelioma

The purpose of this study is to determine whether radiation therapy decreases tumor size and tumor spread. The investigators will consent subjects that have been diagnosed with mesothelioma and will undergo radiation therapy followed by surgical resection as their standard of care. The investigators will collect data from past and future medical records as well as data regarding their health status for their lifetime by reviewing life status, treatment status and CT scans.


Eligibility Criteria:
Inclusion Criteria:

* Subject provides informed consent
* Subject is \>18 years of age
* Subject is deemed competent for making medical decisions
* Subject is scheduled to undergo radiation followed by extrapleural pneumonectomy.
* Subject is a surgical candidate
* A negative pregnancy test is required in women of child-bearing potential, as standard of care.

Exclusion Criteria:

* Subject is \<18 years old.
Inhaled Hypertonic Saline for Bronchiolitis

Study Design: This randomized, double blind, controlled, multi-centre study will occur in the Emergency Department, hospital-based Urgent Care Centre or paediatric outpatient clinics (collectively "ED") of 3 General Hospitals in Ontario and 1 in British Columbia.

Children under age 2 years presenting for unscheduled care to the ED with a diagnosis of moderately severe bronchiolitis (as defined by inclusion/exclusion criteria below) will be approached for entry into the study. Recruitment will only occur when Research Assistants are on duty, is projected to include regular working hours Monday-Friday as a minimum and will continue until the calculated sample size has been obtained (anticipated 12 months). Initial routine assessment by the ED staff will identify potential subjects and Research Assistants will be notified to apply the inclusion/exclusion criteria and obtain informed consent if appropriate. Recruited subjects will be randomized to receive treatment in a double blind fashion with inhalation of nebulized study solution containing either 7% hypertonic saline (HS, study group) or 0.9% saline (NS, control group). Each dose of study solution will also contain a standard dose of bronchodilator (salbutamol, 0.15 mg/kg; 0.03 ml/kg of 0.5% salbutamol nebulizer solution) added by the ED staff. Each participant will remain on the same allocation throughout the protocol and receive 3 consecutive 4ml doses of the assigned study solution with salbutamol over a 1-hour period.

Eligibility Criteria:
Inclusion Criteria:

1. Age under 2 years
2. History of viral upper respiratory infection within previous 7 days
3. Wheezing or crackles detected on chest auscultation
4. Respiratory Distress Assessment Instrument (RDAI) score of 4 or greater or oxygen saturation (SaO2) of 94% or less in room air.

Exclusion Criteria:

History of immunodeficiency, chronic cardiopulmonary disease (other than past history of wheezing), Down syndrome, gestational age under 34 weeks.

Severe illness at presentation as defined by any of the following Respiratory rate greater than 80/min SaO2 less than 88% in room air Need for assisted ventilation Use of nebulized HS within previous 12 hours Previous enrollment in this study.
Improving Defibrillation Pad Position

Manufacturer's diagrams showing defibrillation pad positioning (as used on public access defibrillators) are anatomically incorrect and are likely to lead to poor position of defibrillation pads, with reduced defibrillation efficacy.

We will ask untrained members of the public to observe the diagrams and place pads as indicated on the diagram. We will asses the accuracy of pad placement and repeat the study using an anatomically correct diagram to see if we can improve the accuracy of pad placement.

As above

Eligibility Criteria:
Inclusion Criteria:

- 16 yrs age and willing to participate.

Exclusion Criteria:

* Previous BLS training
* Previous AED training
* Clinical staff (doctor, nurse, HCA, paramedic etc)
Engaging Men in Weight Loss With a Game-based mHealth and Neurotraining Program

Men in the United States have an exceptionally high prevalence of overweight and obesity, i.e., 71.3%, and 42% of men are currently attempting weight loss. However, men are dramatically underrepresented in weight loss programs. Attempts to modestly adapt standard weight loss programs have seen only minimal success. Mobile applications (mHealth apps) have attractive features, but have low male enrollment and poor efficacy as conventionally delivered. A gamified mHealth program offers the possibility of engaging men and enhancing efficacy given that (1) video gaming is highly appealing to men; (2) gamification features (e.g., digital rewards for attaining "streaks" and milestones, competition) are known enhance enjoyment and motivation and facilitate desired behaviors; and (3) "neurotraining" video games featuring repetitive action mechanics, adaptive difficulty, and feedback can train inhibitory control, a basic brain capacity to inhibit intrinsically-generated approach responses that is strongly linked to body mass and the consumption of high-calorie foods. This project evaluates long-term engagement and outcomes of a professionally-designed, game-based weight loss program. As such, 228 overweight men will be randomized to: (1) a 12-month mHealth weight loss program that includes digital self-monitoring, simplified and self-selected dietary targets, physical activity and a control (sham) non-game neurotraining, or (2) a fully-gamified version of this same program, comprised of a behavior change program featuring team-based competition, digital reinforcers for attainment of streaks and milestones, and an integrated neurotraining video game. Aims include evaluating the efficacy of the gamified program in terms of weight loss, diet and physical activity at 12 months, as well as evaluating hypothesized mediators (inhibitory control and engagement), (enjoyment and compliance) and moderators (baseline frequency of video game play and implicit preferences for Inhibitory Control Training-targeted foods).


Eligibility Criteria:
Inclusion criteria:

* Individuals must be of overweight or obese BMI (25-50 kg/m)
* Individuals must be adults (aged 18-65)
* Able to engage in physical activity (defined as walking two city blocks without stopping)
* Individuals must also provide consent for the research team to contact their personal physician, if necessary, to provide clearance for the prescribed level of physical activity (i.e., walking) or to consult about rapid weight loss
* Have moderate-to-high implicit preference for high-calorie foods
* Satisfactory completion of all enrollment procedures\]

Exclusion criteria:

* Medical condition (e.g., cancer, type I diabetes, renal failure), heavy alcohol use, or psychiatric condition (e.g., active substance abuse, eating disorder) that may pose a risk to the participant during intervention or cause a change in weight
* Recently began or changed the dosage of medication that can cause significant change in weight
* History of bariatric surgery
* Weight loss of ≥ 5% in the previous 3 months
Effectiveness of Dual Light Electric Toothbrush vs. Manual Toothbrush in Orthodontic Patients Undergoing Oral Surgery

The study is a randomized clinical trial to compare the effectiveness of a dual light ultrasonic toothbrush on periodontal health in orthodontic patients undergoing surgery.

Patients with cleft lip and palate undergo bone graft and orthognathic surgery. The study will compare the periodontal outcomes in patients who use these toothbrushes during the post-surgical period.

Pilot Study, Randomized Control Clinical Trial, study groups 1) Craniofacial and/or unilateral and bilateral cleft palate patients undergoing orthognathic surgery . 2) Craniofacial and/or unilateral and bilateral cleft palate patients undergoing bone-graft surgery 3) Craniofacial and/or unilateral and bilateral cleft palate patients with no pending surgery. Three Investigational device include Dual Light Therapy Sonic Toothbrush (BristlTM Toothbrush), Sonic Toothbrush(BRistlTM) and manual toothbrush to target disease gingivitis in 189 patients. Categorical variables scored from Plaque Index and Gingival Index will be analyzed using Fisher exact test and McNemar test. Parametric methods will be used to analyze data from Bleeding on Probing and Periodontal Probing Depth. To determine differences between groups and within each test at all time points, Student t-test will be used.

Eligibility Criteria:
Inclusion Criteria:

* Patient of record of the Craniofacial and Special Care Orthodontic Clinic at Children's Hospital Los Angeles
* Between the ages of 6 and 20 years
* Physical status of ASA I or II
* Diagnosis of craniofacial and/or isolated, complete or incomplete, bilateral or unilateral cleft lip and palate

Exclusion Criteria:

* physical inability to brush teeth
* cognitive inability to comprehend and follow directions.
Effect of Orange Juice and Healthy Diet on Cardiometabolic Risk Factors of Individuals With Metabolic Syndrome

This study aimed to verify if combination of a healthy diet and orange juice consumption can minimize cardiometabolic risk factors for Metabolic Syndrome (MetS)

The clinical study was parallel, controlled, and randomized with metabolic syndrome subjects (ATPIII, AHA / NHLA) aimed at the consumption of an energy-balanced balanced diet for 12 weeks and divided into two groups: Control (n = 38): dietary guidance only; and Orange Juice (n = 38): diet guidance associated with 500 mL / day of 100% whole orange juice. The recruitment process began in June 2016, the intervention was carried out from September 2016 to December 2016, and the data analysis started in January 2016. The sample number took into account variances on LDL-C, with a type I error α = 0.05 and a type II error β = 0.2 (80% power). The minimum sample size should have 32 individuals per group (n = 64). Considering an approximately 15% dropout rate, the final sample size of study was constituted by 38 individuals per group. Primary and secondary endpoints were the reduction of LDL-C and modification of the levels of cardiometabolic risk factors, inflammatory and hemodynamics parameters, respectively. Kolmogorov Smirnov and Levene test assessed normality and homogeneity of data, respectively. T-test was conducted to identify possible differences between OJ and control groups at baseline. A linear mixed-effects model was apply to determine the time effect within and between groups (Sidak post hoc) and P significance was set up ≤ 0.05. The assessment of body composition, metabolic biomarkers and food intake were analyzed over a 12-week intervention.

Eligibility Criteria:
Inclusion Criteria:

* Three or more of the risk factors of MS: (1) waist circumference man ≥ 102 cm and woman ≥ 88 cm; (2) triglycerides ≥ 150 mg / dL; (3) HDL-C man ≤ 40 mg / dL and woman ≤ 50 mg / dL; (4) blood pressure ≥ 130 / ≥ 85 mm Hg and (5) fasting glucose ≥ 100 mg / dL (common diabetes, high blood pressure);
* 25 ≥ BMI ≤ 39.9 kg / m - overweight to grade II obesity;
* Like to consume orange juice;

Exclusion Criteria:

* Pregnant / nursing;
* Use of vitamins or vitamin-food supplements in the last three months;
* Individuals with diseases that require specific diet recommendations such as diabetes mellitus with insulin therapy and carbohydrate counts, cancer, chronic liver and kidney disease.
Red Cell Distribution Width,,NT-proBNP and cTnT in Acute Myocardial Infraction Patient

the study is to investigate the relationship of several parameters of complete blood count (CBC) including RDW with N-terminal pro-B-type natriuretic peptide (NT-proBNP) and cardiac troponin T (cTnT) in a cohort of acute myocardial infarction (AMI) patients.

Patients and methods:

* Type of study: Observational prospective study
* Place of study: Sohag cardiology and gastroenterology center, department of cardiology and cardiac care unit.
* Ethical considerations: This research will be revised by the Scientific Ethical Committee of Sohag University Hospital. Consents will be taken from all patients.
* Study Methods:

  * A prospective study on 30 patients diagnosed as acute myocardial infarction on which measurement of CBC, serum NT-proBNP, and cTnT levels will be performed at the time of admission and by the time of discharge.
  * All patients included in the study will be subjected to:

    1. Full history:

       1. Personal history: e.g. age, sex and smoking.
       2. Family history of cardiac diseases
       3. Medical history of: Hypertension, Ischemic heart disease, prior coronary artery bypass grafting, Prior Percutaneous coronary intervention, Prior Stroke, Prior Atrial fibrillation, therapeutic history
    2. Detailed clinical examination
    3. Electrocardiogram
    4. Laboratory investigation:

       1. Routine investigation in the form of CBC including RDW
       2. Specific investigation which include NT-proBNP and cTnT

Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed as acute myocardial infarction and admitted to department of cardiology and cardiac care unit at Sohag cardiology and gastroenterology center according to inclusion and exclution criteria

Exclusion Criteria:

Patient with:

* Decompensated heart failure
* Pulmonary hypertention
* Acute pulmonary embolism
* Septic shock