cyrilzakka/clinical-trials huggingface dataset:
A Pilot Study to Investigate Administration of Mannitol Via a Novel Dry Powder Inhaler Device

A novel dry powder inhaler device will be used to administer mannitol to healthy subjects and subjects with bronchiectasis in single doses higher than previously given.The main objective is to assess tolerability of these doses using the new device.


Eligibility Criteria:
Inclusion Criteria:

* healthy or bronchiectatic; 18 years and over

Exclusion Criteria:

* uncontrolled asthma, unstable
Comparison of Rocabado Approach Versus Postural Correction Exercises on Kinesiophobia and Interincisal Distance in Patients With Temporo-Mandibular Dysfunction

Temporo-mandibular dysfunction can cause pain and tenderness of jaw so posture correction exercises and Rocabado exercises will be performed targeting jaw opening and kinesiophobia.

Temporo-mandibular dysfunction refers to pain in area of Temporo-mandibular joint and masticatory muscles.Temporo-mandibular dysfunction can cause pain or tenderness of jaw and aching pain in and around the ear along with difficulty in chewing.In addition to these symptoms the Temporo-mandibular dysfunction results in impairment of mouth opening. So the posture correction exercises and Rocabado exercises will be used to treat patients which will target jaw opening and kinesiophobia.

Eligibility Criteria:
Inclusion Criteria:

* Male and female of 18 to 45 years with TMD pain for less than six months and pain rating at least moderate in severity
* Must not be receiving any treatment for TMD at the onset of the study (for example, an occlusal splint, prescription medication)
* Pain must have been of masticatory muscle origin
* Pain on jaw movement, headache and referred pain are suggestive of a muscular problems.

Exclusion Criteria:

* Patients of Systemic rheumatic disease \& Fibromyalgia
* Dental pathology
* Orofacial pain disorders
* Cervical structural pathology
* Current use of analgesics more than 3 days per week
* Current use of narcotics, hypnotic drugs, sedatives, or muscle relaxants
Pain Control in Children and Adolescent After Thoracic Surgery: The Effect of Gabapentin

The study is performed in patients aged 5-18 years after thoracic surgery. The primary aim of this trial is to determine whether the use of gabapentin as a component of multimodal analgesic regiments reduces pain scores following thoracic surgery in pediatric patients. The secondary objective of the trial are to evaluate whether the use of gabapentin reduces postoperative anxiety scores and consumption of ropivacaine with fentanyl, decreases side-effects, and improves patient satisfaction.

The subjects are randomized to the Gabapentin or Placebo group. All patients receive preoperative gabapentin (15 mg/kg, treatment) or placebo, respectively and after surgery either gabapentin (7,5 mg/kg, treatment) or placebo 2 times per day for 3 days, respectively.

Patients are subjected to the same anaesthesia protocol. Postoperative analgesia are achieved with either continuous ropivacaine 0.2%/fentanyl 5.0 μg/ml infusion through a thoracic epidural catheter (N=40; Gabapentin n=20, Placebo n=20), or intravenous infusion of morphine (N=40; Gabapentin n=20, Placebo n=20). All patients receive acetaminophen and non-steroidal anti-inflammatory drugs, and metamizol as a "rescue drug"

The intravenous infusion of morphine grup was expanded on the basis of the bioethics commission's decision KB-125/2019 (N=64; Gabapentin n=32, Placebo n=32).

Eligibility Criteria:
Inclusion Criteria:

* 5 - 18 years of age;
* surgery: lateral thoracotomy or Ravitch procedure;
* ASA 1-3;
* postoperative analgesia: thoracic epidural analgesia or intravenous infusion of morphine.

Exclusion Criteria:

* allergy or sensitivity to gabapentin;
* history of chronic pain or daily analgesic use;
* diagnosed with psychiatric disorders;
* treated oncologically;
* with impaired verbal communication;
* the lack of postoperative chest drainage.
Carmustine in Treating Patients With Recurrent Malignant Glioma

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of carmustine in treating patients who are undergoing surgery for recurrent malignant glioma.

OBJECTIVES:

* Determine the safety of polifeprosan 20 with carmustine implant (GLIADEL) in patients undergoing surgery for recurrent malignant glioma.

OUTLINE: This is a dose escalation study.

All patients undergo maximal tumor resection. At the time of surgery, groups of 6 patients receive up to 8 polifeprosan 20 wafers containing increasing doses of carmustine implanted into the resection cavity.

Patients with an intraoperative diagnosis other than glioblastoma multiforme or anaplastic astrocytoma do not receive wafer implantation, and are removed from study.

Patients are followed 3, 6, and 12 months after implantation.

PROJECTED ACCRUAL: A total of 52 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Pathologically confirmed recurrent malignant glioma for which surgery is indicated
* Unilateral, supratentorial, solitary lesion at least 1.0 cm in diameter on contrast-enhanced CT or MRI

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* Karnofsky 60-100%

Life expectancy:

* At least 8 weeks

Hematopoietic:

* WBC at least 3,500/mm\^3
* Platelet count at least 100,000/mm\^3

Hepatic:

* Bilirubin, AST, ALT, and alkaline phosphatase less than 2.5 times normal

Renal:

* Creatinine less than 1.5 times normal
* BUN less than 2.5 times normal
* Protein no greater than 3 g/dL
* No gross hematuria

Other:

* No hypersensitivity to nitrosoureas
* Not pregnant
* Fertile patients must use effective contraception
* No concurrent life threatening disease

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* No concurrent immunotherapy during first 8 weeks of study

Chemotherapy:

* At least 4 weeks since chemotherapy (6 weeks since nitrosoureas)
* No concurrent chemotherapy during first 8 weeks of study

Endocrine therapy:

* Not specified

Radiotherapy:

* Prior definitive external-beam radiotherapy (i.e., at least 5,000 cGy) required
* No concurrent radiotherapy or brachytherapy during first 4 weeks of study

Surgery:

* Prior cytoreductive surgery for supratentorial brain tumor required
* Biopsy alone not sufficient

Other:

* No concurrent investigational therapy during first 8 weeks of study
Russian National Registry of LAAO

The first Russian registry presents data from two hundred consecutive patients with nonvalvular atrial fibrillation, who undergone left atrial appendage occlusion (LAAO) using the Watchman device and the Amplatzer cardiac plug. This government-funded catheter-based LAAO program was started in September 2015 and was completed in December 2017. Data collection was finished in December 2018. Five clinics agreed to participate in the study.

Patients' baseline characteristics, procedure, and follow up data were collected according to established registry protocol. Patients were followed at 45 days, 3, 6 and 12 months after enrollment. At each follow-up visit, the data regarding clinical events and healthcare utilization was collected.


Eligibility Criteria:
Inclusion Criteria:

* age ≥18 years nonvalvular atrial fibrillation,
* CHA2DS2VASc ≥2,
* high risk of hemorrhagic events,
* non-compliance with pharmacological anticoagulant therapy

Exclusion Criteria:

* significant mitral valve disease,
* left ventricular ejection fraction \<35%,
* the tendency to systemic thrombosis,
* severe co-morbidities
Functional Outcome in Operative and Nonoperative Management in Isolated Greater Tuberosity Fracture of Humerus Bone

Constant score for functional outcome in operative and non-operative management in isolated greater tuberosity fractures of humerus bone.

Fractures of the greater tuberosity (GT) often occur with more complex proximal humerus fractures and are less frequently observed as an isolated pathology. Only 14-20% of proximal humerus fractures are isolated lesions of the GT. Up to 30% of these fractures are associated with anterior glenohumeral dislocations. According to Neer, a displacement of the fragment \>5mm and 30°, or \>3 mm of displacement in active patients involved in frequent overhead activity is believed to be an indication for operative treatment. However, indication for all other fractures had managed by nonoperative treatment is unclear. Currently, there is a lack of evidence in the literature to support either conservative or operative treatment strategies in GT humerus fractures. The fracture type and the etiology of the fracture impact the decision- making and the final outcome also remains unclear. age of more than 65 years as an important risk factor for secondary displacement in the conservative management of fractures of the greater tuberosity. Furthermore, fracture type and shoulder joint dislocations were factors associated with show increased relative risks for secondary fragment displacement.

Eligibility Criteria:
Inclusion Criteria:

* 1-history of traumatic isolated GT fracture.

Exclusion Criteria:

- 1- associated proximal humeral fracture.

2 - previous shoulder pathology.
Time-based Effects of Stretching on Hamstrings Muscle Strength

Stretching is reported to have detrimental effects on strength and thus avoided prior to strength training session. Do stretching indeed decreases muscle strength? To examine the time course (immediate, 10- and 20-min post stretching) for the effects of 2, 4, and 8 min long duration of static-stretching (SS) on isometric maximum voluntary contraction (MVC) force of hamstring muscles.

OBJECTIVE: To examine the time course (immediate, 10- and 20-min post stretching) for the effects of 2, 4, and 8 min long duration of static-stretching (SS) on isometric maximum voluntary contraction (MVC) force of hamstring muscles.

METHODS: Pretest-posttest experimental design. Total of 14 subjects with mean age 25 years participated in three experimental trials on three different days. On day-I for static-stretching for 2 minutes (SS2), day-II for 4 minutes (SS4), and day-III for 8 minutes (SS8). Testing was conducted before (pre), immediately after (post), and at 10 and 20 min post stretching. MVCF was measured using strain gauze as the main outcome measure.

Eligibility Criteria:
Inclusion Criteria:

* Subjects used to engage in 1 to 5 hours of physical activity per week. They were not doing stretching exercises regularly.

Exclusion Criteria:

* Subjects having any current injury specific to lower limb joints or current neuromuscular disease were excluded from the study.
MBT in Groups for Adolescents With BPD or Subthreshold BPD Versus TAU - the M-GAB Randomized Controlled Trial

Background: Although it is now possible to diagnose Borderline Personality Disorder (BPD) in adolescents younger than 18 years according to the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V), and studies indicates that BPD can be reliably diagnosed in adolescence, only a few evidence based treatment programmes for adolescent BPD exists. Mentalization-based treatment (MBT), including group psychotherapy, has repeatedly shown to be effective in treating adult BPD, but in the case of adolescents, only individual MBT have been tested and found to be effective.

Aims/hypotheses: We will test whether group based MBT (MBT-G), including an introductory programme for patients (MBT-I) and their parents (MBT-P) is more effective than Treatment As Usual (TAU) in treating adolescents with BPD or subthreshold BPD.

Methods/Design: 112 patients referred to child and adolescent psychiatric clinics in Region Zealand will be randomized to either MBT or TAU. Inclusion criteria: Meeting DSM-V BPD-criteria at the threshold (five criteria) or sub threshold level (4 criteria). Follow-up will be at three and 12 months.

Discussion: Early intervention is especially important in relation to personality psychopathology and has long-term benefits for patients, their families and society. In addition to being cost effective, using the group modality in the treatment of BPD may have several advantages. This is the first Randomized Controlled Trial (RCT) to test the effectiveness of MBT in groups for adolescents.


Eligibility Criteria:
Inclusion Criteria:

* Meet a minimum of 4 DSM-5 BPD criteria
* Have parent's or parent substitute's commitment and ability to participate in the MBT-Parents program.
* Score 67\< BPFS-C

Exclusion Criteria:

* Comorbid diagnosis of pervasive developmental disorder, learning disability (75 \< IQ), anorexia, current psychosis, diagnosis of schizophrenia or schizotypal personality disorder, antisocial personality disorder as well as any other axis-I or axis-II psychopathology considered to be the primary diagnosis.
* Current psychiatric inpatient treatment
* Current (past two months) substance dependence (but not substance misuse)
* Participation in concurrent psychotherapeutic treatment outside the MBT program
* Not able to speak Danish
* Lack of informed consent
The Prevelence of HBB c.93-21 G-A in β Thalassemia Patients

* To design an amplification-refractory mutation system (ARMS) for the DNA diagnosis of the IVS I-110 (G\>A) \[HBB:c.93-21G˃A\] mutation.
* To detect the prevelence of the mutation among Assiut University Hospital patients.
* Phenotype/genotype correlation of the mutation.

* The β-thalassaemias result from over 300 gene mutations (Kurtoğlu A,et al 2016)
* These mutations are regionally specific and the spectrum of mutations has been determined for most at-risk populations. The strategy for identifying β-thalassaemia mutations is usually based on knowledge of the common mutations in the ethnic group of the individual being screened (Old JM, 2007).

The β globin gene mutation \[HBB:c.93-21G˃A\] or IVS I-110 (G\>A) is the most common β globin gene mutation in the Mediterranean region (Old JM, 2007). . There is no consensus about the % of the mutation among β thalassemic patients in Egypt \[has been reported (25.8%) by El-Gawhary et al. 2007, (33.75%) by Soliman et al. 2010, (48%) by El-Shanshory et al. 2014, (22%) by Elmezayen et al. 2015 and (34%) by Elhalfawy et al. 2017\].

According to the HbVar site, it represents 33% of the β globin gene mutations in the Egyptians. 28.5% according to Henderson S ,et al 2009 .

* The mechanism of this mutation depends on formation of a new splicing site resulting in 80% abnormal spliced mRNA and 20% normal mRNA .
* The molecular characterization of the globin gene mutation is necessary for definite diagnosis, genetic counseling, and in prenatal diagnosis.
* The amplification-refractory mutation system (ARMS) is a simple method for detecting any mutation involving single base changes or small deletions.
* The DNA is analyzed after amplification by PCR for Detection of point mutation IVS I-110 (G\>A) by Using primer pairs that only amplify individual alleles.

Eligibility Criteria:
Inclusion Criteria:

* β thalassemia (suspected \& clinically diagnosed cases)

Exclusion Criteria:

* Iron deficiency anaemia, anaemia of chronic disease, types of haemolytic anaemias other than thalassemia, other types of thalassemia and Hb variants.
Comparison of the Vocal Cord Imaging Techniques After Thyroidectomy

Recurrent nerve palsy is a complication of thyroidectomy. Most surgeons want to visualize the vocal cords after tyroidectomy. The aim is to compare the direct laringoscopy, videolaringoscopy, fiberoptic laringoscopy and ultrasonography methods in terms of efficacy, duration and hemodynamic responses during the procedure.

The vocal cord will be visualised after the extubation with one of the following methods:

direct laringoscopy videolaringoscopy fiberoptic laringoscopy ultrasonography The of efficacy of the method (0= not able to visualize the vocal cords, 1= the vocal cords were visualized) duration of the procedure and hemodynamic responses (heart rate, mean arterial pressure) during the procedure will be compared between the groups.

Eligibility Criteria:
Inclusion Criteria:

* Benign or malignant thyroid pathology

Exclusion Criteria:

* anticipated difficult intubation
PRagmatic Trial Of Messaging to Providers About Treatment of Heart Failure at Inova

A randomized, single-blind intervention trial to test the comparative effectiveness of an electronic health record best practice advisory system that informs clinicians of guideline-indicated and FDA-approved heart failure medications currently not prescribed to their patients with heart failure versus usual care (no alert and how things are done currently). The purpose of the alert is to stimulate appropriate medication prescription for patients with heart failure and a reduced ejection fraction. This will be done across outpatient Inova clinics and at the five Inova hospitals.


Eligibility Criteria:
Inclusion Criteria:

* Age\>18 Years
* Seen by a Cardiologist in an Inova clinic or Inova hospital setting
* Left Ventricular Ejection Fraction ≤40%

Exclusion Criteria:

* Opted out of EHR-based research
* Hospice care
* Already receiving maximally titrated doses of each of the four classes of evidence- based HFrEF medical therapy
* Prior heart transplant
Ethical Deliberation in the Intensive Care Unit, Impact of Formalized Multidisciplinary Team Meetings, a Pilot Study

Most patients who die in the intensive care unit do so after a withholding or withdrawing of life sustaining treatments (WWLST) decision. The implementation of formalized interdisciplinary team meetings for ethical deliberation in the ICU may improve nurses participation in WWLST decisions. The investigators decided to implement such team meetings in their ICU. At this occasion, the investigators will measure job satisfaction, job related frustration and ethical decision making climate climate.

Most patients who die in the intensive care unit do so after a withholding or withdrawing of life sustaining treatments (WWLST) decision. Because those decisions are value-laden, guidelines as well as french regulations recommend that they should involve not only medical doctors but also nurses. Despite that, nurses' involvement remains incomplete. Poor collaboration between doctors and nurses on ethical decisions is associated with job dissatisfaction, burnout and desire to quit. The implementation of formalized interdisciplinary team meetings for ethical deliberation in the ICU may improve nurses participation in WWLST decisions.

For those reasons the investigators decided to implement such team meetings in their ICU. At this occasion, the investigators will measure job satisfaction, job related frustration and ethical decision making climate climate.

Eligibility Criteria:
Inclusion Criteria:

* All patients admitted in the ICU

Exclusion Criteria:

* Age below 18
An Evaluation of Internet-based Carbohydrate Counting Education for Adolescents With Type 1 Diabetes

Helping individuals with diabetes to control their blood sugars through self-management is an important goal, and counting carbohydrates (CHO) remains a key part of diabetes education and management. There is very little research examining CHO counting education with adolescents who have type 1 diabetes (T1DM). The purpose of this pilot study is to evaluate a newly developed internet-based teaching module of CHO counting for adolescents, ages 12-17 years, with T1DM and who do not regularly CHO count and require instruction. A secondary aim is to assess feasibility for a future, larger-scale clinical trail. An effective web-based CHO counting tutorial could be used to strengthen current diabetes education programs and may serve as a basis for developing other teaching modules. Advantages of web-based teaching include convenience, increased accessibility, and the ability to review and reinforce teaching concepts through repetition. It may also encourage adolescents to take the initiative for their own diabetes care, beginning with a self-directed, active learning experience.


Eligibility Criteria:
Inclusion Criteria:

* Adolescents aged 12-17 years with a diagnosis of T1DM for more than 1 year
* Followed at the SickKids Diabetes Clinic
* Have access to a computer with Internet connection
* Able to communicate in English

Exclusion Criteria:

* Patients with type 2 diabetes, medication-induced diabetes or other forms of non T1DM
* Patients with Celiac disease, due to differences in prescribed dietary regimen
* Patients who are unable to communicate in English
* No computer or internet access
* Patient with cognitive delay impeding their ability to learn CHO counting
* Patients who have attended a CHO counting class within the past 6 months
* Patients who do not eat the foods presented on the planned meal \& snack trays
A Prospective Registry of Pediatric Cellular Therapy Patients at Risk for Endothelial Dysfunction, Sinusoidal Obstruction Syndrome and/or Multi-Organ Dysfunction Syndrome (MODS).

This is a prospective international multi-center registry and biorepository trial of children and adolescents/young adults (AYA) undergoing hematopoietic cell transplantation (HCT) to assess the impact of endotheliopathies in the HCT setting as a contributor of significant morbidity and mortality.

Primary:

* To evaluate the proportion of pediatric patients undergoing hematopoietic cell transplant (HCT) who develop endotheliopathies (SOS, TMA, DAH and IPS) and/or MODS within 100 days of such therapies.
* To evaluate the proportion of pediatric patients undergoing hematopoietic cell transplant (HCT) who experience abnormal levels of circulating angiogenic, vascular permeability and inflammatory factors within 100 days post HCT-CT in the setting of endotheliopathies.

Secondary/Exploratory Objective(s):

* To determine the impact of endotheliopathies in the HCT setting on the overall survival.
* To assess the efficacy of specific prophylaxis and treatment strategies directed at endotheliopathies (SOS, TMA, DAH and IPS) post-HCT among enrolled children on overall survival.
* To assess whether exposure to immunotherapies (CAR-T, PD-1 Inhibitors, bispecific T-cell engager (BiTE) antibodies and antibody drug conjugates) prior to HCT affects post-HCT outcomes (endotheliopathies and MODS).

Eligibility Criteria:
Inclusion Criteria:

* Children, adolescents and young adults (AYA) 0-26 years of age undergoing HSCT.
* Recipients of autologous and allogeneic HSCT.
* Any preparative regimen.

Exclusion Criteria:

* Any patient who does not consent/assent to participation.
* Any patient for whom 5 mL blood sample(s) drawn at specified intervals would pose any more than minimal risk, as defined by institutional guidelines and at discretion of treating physician will be ineligible for biorepository banking.