cyrilzakka/clinical-trials huggingface dataset:
Type 1 Diabetes Virtual Self-management Education and Support

OVERVIEW: People living with type 1 diabetes (T1D) are expected to fit self-management and regular clinical consultations into busy lives. T1D self-management programs that offer frequent contact with care teams are most effective in helping patients achieve optimal glycemic control. However, this is difficult to deliver in the context of current T1D care which involves time-consuming in-person visits during working hours. The proposed study will test a virtual health care intervention to deliver "high frequency, low touch" care aimed at improving metabolic control, while reducing the burden on individuals and their healthcare teams.

STUDY DESIGN: A pragmatic multicenter, open-label, randomized trial to evaluate the short-term effectiveness of a multifaceted virtual health care intervention in improving glycemic control in individuals with T1D. Planned recruitment is 580 participants from 10 specialized T1D centres in Ontario.

INTERVENTION: Our intervention will include 1) frequent, brief virtual visits between patients with T1D and certified diabetes educators (conducted in real time using a secure telemedicine video interface accessible from any PC, tablet or smart phone) combined with automatic appointment reminders, and 2) a centralized web-based platform to provide educational classes, tools, and resources for diabetes self-management. Virtual visits will be an adjunct to routine in-clinic visits for blood pressure monitoring, foot checks, and surveillance for other complications of diabetes. This approach aims to enable patients to receive more education and support than is feasible in traditional health care models, and in a way that is more seamless (i.e. results in fewer disruptions to their daily life) and tailored to their individual needs based on their stage in life.


Eligibility Criteria:
Inclusion Criteria:

1. Outpatients ≥18 years of age
2. Physician diagnosis of type 1 diabetes
3. Currently on an insulin pump or using multiple daily insulin injections.
4. HbA1c ≥ 7.5% on most recent laboratory report, within the last 4 months
5. Has access to a mobile device or computer/tablet with a video camera
6. Seen for at least one visit in the previous 6 months by participating certified diabetes educator at the selected diabetes clinic OR If a transitioning patient: Currently enrolled in a diabetes program below AND had at least one visit or touch-point prior in the previous 6 months by participating certified diabetes educator at on of our participating diabetes clinics
7. OHIP coverage
8. Currently using an active email address or be willing to obtain an email address
9. Has consistent and reliable access to internet
10. Willing and able to comply with scheduled in-person and virtual visits for 6 month intervention period

Exclusion Criteria:

1. Diagnosed with non-Type 1 diabetes
2. Unable to use a computer/tablet or mobile phone
3. Pregnant
4. On dialysis
5. Unable to fluently speak or read English (self-reported)
Pharmacogenetic Testing in Children With Persistent Gastroesophageal Reflux Disease

This study will use a 22 gene pharmacogenomics panel on 30 children with persistent Gastroesophageal Reflux Disease (GERD) who have not responded to therapy.

This study will assess the clinical utility of pharmacogenomics testing in the clinical management of children with refractory GERD, despite adequate therapy and the role of pharmacogenomics in selecting the right acid suppressive therapy based on each patient's symptoms and pharmacogenomics results.

Eligibility Criteria:
Inclusion Criteria:

* persistent gastrointestinal symptoms (GI) suggestive of gastro esophageal reflux disease (GERD) despite adequate therapy
* persistent evidence of abnormal reflux indices' and acid exposure on esophageal multichannel pH impedance study despite adequate therapy
* persistent endoscopic evidence of reflux esophageal disease despite adequate therapy

Exclusion Criteria:

* children with eosinophilic esophagitis diagnosis
* children with any esophageal surgical intervention like fundoplication, tracheoespahgeal fistula repair or esophageal atresia repair
* children with other diseases that can affect the esophagus, like Crohn's disease or food protein-induced enterocolitis syndrome (F-PIES)
* Children who do not have research authorization in their chart
Development and Validation of a Sputum Biomarker mRNA Panel for the Diagnostic Work-up of Asthma 3

The main objectives of the study are:

1. To unravel the importance of molecular phenotyping in predicting the response to classical anti-asthma treatment (leukotriene antagonists)

The investigators have developed a non-invasive technique based on mRNA analysis of induced sputum that enables us to study airway inflammation in detail. This technique forms the basis for our current project based on the following hypotheses:

1. Different molecular asthma phenotypes exist: a Th2 phenotype and a non Th2 phenotype as reported by Woodruff and colleagues (Woodruff PG et al). Sputum mRNA cytokine levels can be used to diagnose Th2 asthma and discriminate this from non-Th2 asthma.
2. Based on our previous research and preliminary data that non-Th2 asthma can be further divided in Th17 asthma and Th1+Th2 asthma; besides these, a fourth group without Th2, Th17 or Th1 characteristics also exist.
3. These subgroups have different responses to anti-leukotrienes.


Eligibility Criteria:
Inclusion Criteria:

* uncontrolled persistent asthmatics on daily inhaled corticosteroids (GINA)

Exclusion Criteria:

* viral/fungal/bacterial infection +fever (\<1 month)
* asthma exacerbation (\<3 months)
* other respiratory disease (CF, ciliary dyskinesia,bronchiectasis)
* cardiac patients using beta-blockers
Triceps Taping on Elbow Flexion Tightness in Extended Erb's Palsy

To determine the role of using Kinesiology tape on the prevention of elbow flexion tightness in infants with extended Erb's palsy.

PURPOSE:

To determine the role of using Kinesiology tape on the prevention of elbow flexion tightness in infants with extended Erb's palsy.

BACKGROUND:

BACKGROUND Neglecting or even delay in Brachial plexus birth palsy management, may result in substantial and chronic impairment. Physiotherapy, microsurgical nerve reconstruction, secondary joint corrections, and muscle transpositions are employed to help the child maximize function in the affected upper extremity. Kinesiology taping can have an effect on muscle performance and support joint by improving proprioception, normalizing muscle tone, correct the inappropriate positions and stimulate skin receptors. The possible effect of kinesiotaping on muscle strength has been investigated by numerous researchers that have theorized that kinesiotaping facilitates an immediate increase in muscle strength by generating a concentric pull on the fascia.

HYPOTHESES:

There will be no role of Kinesiology tape on the prevention of elbow flexion tightness in infants with extended Erb's palsy.

RESEARCH QUESTION:

Is there a role of using Kinesiology tape in preventing elbow flexion tightness in infants with extended Erb's palsy?

Eligibility Criteria:
Inclusion Criteria:

* 3-6 months of age
* had unilateral extended BPBP involving cervical 5, 6, and 7 roots lesion
* based on an EMG referral by a physiatrist
* had positive grasp reflex on both sides
* had asymmetrical Moro reflex on the affected side.

Exclusion Criteria:

- surgical interferences arm fracture or dislocations hypersensitivity to latex and adhesive tapes
Combination Antimalarials in Uncomplicated Malaria

The purpose of this study is to study the efficacy of sulfadoxine-pyrimethamine on its own and compare this with efficacy of a new combination antimalarial therapy, either sulphadoxine-pyrimethamine plus artesunate or artemether-lumefantrine.

The resistance of Plasmodium falciparum to anti-malarial drugs is a serious impediment to the control of malaria. In the South East African Combination Anti-malarial Therapy (SEACAT) evaluation, there will be a comprehensive evaluation of phased introduction of combination anti-malarials (CAT) in Mozambique, Swaziland and South Africa. In order to facilitate formulation of an effective regional drug policy and provide a database for decision-making on the implementation of combination therapy, it is essential that the in vivo response to CAT in all three countries be investigated. An SP therapeutic efficacy study will be conducted according to this modified World Health Organization (WHO) protocol to guide the selection of CAT. After CAT is introduced an in vivo CAT efficacy study will then be conducted to evaluate the efficacy of artesunate plus SP (or artemether-lumefantrine in KwaZulu Natal and Limpopo). In areas of low intensity malaria transmission the CAT in vivo study results will be compared across sites and with those found at baseline with monotherapy, for each site.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, older than 12 months.
* Weight \> 10 kg.
* Diagnoses of uncomplicated acute P. falciparum malaria parasitaemia of up to 250 000 asexual parasite/mcl blood with axillary temperature of greater than and equal to 37.5 or history of fever
* Documented informed consent
* Lives close enough to the health centre for reliable follow up

Exclusion Criteria:

* Has received anti-malarial treatment in the past 7 days.
* Severely ill (based on WHO Criteria for severe malaria ) or if patient is considered, in the opinion of the investigator or designee, to have moderately severe malaria (e.g. prostrate, repeated vomiting, dehydrated).
* Has received cotrimoxazole or chloramphenicol in the past 7 days.
* History of Glucose-6-phosphate dehydrogenase (G6PD) deficiency (not a contra-indication for artemether-lumefantrine).
* Is pregnant or breastfeeding.
* Has a history of allergy to any of the study drugs (including other sulphonamides e.g. cotrimoxazole, other artemisinin derivatives e.g. artemether-lumefantrine).
SCOPE CLI (Shifting Care and Outcomes for Patients With Endangered Limbs - Critical Limb Ischemia)

Given the importance of understanding CLI patients' outcomes and existing gaps in knowledge, there is a pressing need to collect observational data on treatment patterns, adherence to performance measures, and outcomes that are relevant to patients and clinicians. To address this need, the current study will pilot test the research infrastructure and data elements needed to build a larger, national study collecting of the CLI population. It will also provide much-needed preliminary information to identify areas of action that can be targeted in quality improvement programs for this population. Most importantly, it will provide data on health status outcomes in patients with CLI, as a function of individual patient characteristics (demographics, socio-economic and clinical background) and the treatments that patients have undergone. The PORTRAIT-CLI study will also be well equipped to identify potential disparities in the provision of care and patients' outcomes as a function of patient's characteristics.


Eligibility Criteria:
Inclusion Criteria:

All race/ethnicity categories, English or Spanish speaking, men and women

* Age ≥18 years
* Patients presenting with Rutherford Classification 4 (ischemic rest pain), or Rutherford Classification 5 (minor tissue loss: non-healing ulcer, focal gangrene with diffuse pedal ischemia), or Rutherford Classification 6 (major tissue loss: extending above transmetatarsal level, functional foot no longer salvageable) at specialty clinics will prospectively be screened, regardless of whether the patient undergoes endovascular, bypass, amputation, and/or medical therapy.
* Diagnosis is supported by any of the following hemodynamic parameters (assessed pre- procedurally): Ankle pressure lower than 70 mmHg; Toe pressure lower than 50 mmHg or evidence of ischemia by transcutaneous oxygen measurement (tcpO2) \<40 or a skin perfusion pressure (SPP) \<40 or angiographic evidence of significant vascular disease

Exclusion Criteria:

* No other prior surgical or vascular interventions within 2 weeks before and/or planned 30 days after the enrollment
* Acute limb ischemia
* Unable to provide written informed consent
* Currently a prisoner
Observational Study of Muscle Invasive Urothelial Carcinoma Participants Treated With Adjuvant Nivolumab in France

This study will estimate the real-world effectiveness of adjuvant nivolumab therapy in adult participants with muscle invasive urothelial carcinoma (MIUC) in France.


Eligibility Criteria:
Inclusion Criteria:

* Participants with pathological evidence of muscle invasive urothelial carcinoma (originating in bladder, ureter, or renal pelvis) at high risk of recurrence after radical resection with programmed death-ligand 1 (PD-L1) tumour cell expression ≥ 1%:

  * Who received neoadjuvant chemotherapy OR
  * Who did not receive neoadjuvant chemotherapy and who are not eligible or refusing adjuvant cisplatin chemotherapy
* At least 18 years of age at the time of treatment decision
* Decision to treat with adjuvant nivolumab therapy has already been taken
* Participants who provide oral informed consent to participate in the study (or who express non-opposition to data collection during their lifetime for deceased patients enrolled retrospectively)

Exclusion Criteria:

* Participants with a current primary diagnosis of a cancer other than muscle invasive urothelial carcinoma within the past 5 years, ie, a cancer other than urothelial carcinoma that requires systemic or other treatment or has not been treated curatively (as per discretion of the investigator)
* Participants currently enrolled in an interventional clinical trial for their urothelial carcinoma. Patients who have completed their participation in an interventional trial or who are not receiving study drug anymore and who are only followed-up for overall survival (OS) can be enrolled. Patients enrolled in a clinical trial not evaluating an investigational drug can be enrolled (e.g. trial investigating novel imaging modalities).
* Pregnant women
* Participants under guardianship
A Study to Determine Frequency of DNA-repair Defects in Men With Metastatic Prostate Cancer

The purpose of this study is to evaluate the prevalence of 4 or more DNA-repair gene defects in a population of men with metastatic Prostate Cancer (PC) and to use the reported DNA-repair gene defects to assess biomarker eligibility for niraparib interventional studies.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of metastatic (Stage IV) prostate cancer (PC), confirmed by either biopsy of a metastatic tumor site or history of localized disease supported by metastatic disease on imaging studies (that is \[i.e.\], clearly noted in hospital/clinical records)
* Signed Informed consent form (ICF)
* No condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (for example \[e.g.\], compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
* Willing to provide a saliva, blood, and/or archival tumor tissue sample for genomic analysis
* No prior poly (adenosine diphosphate \[ADP\]-ribose) polymerase inhibitor (PARPi) for the treatment of prostate cancer
* No prior DNA-repair gene defect test results from a Janssen sponsored interventional trial
Glossopharyngeal Nerve Block on Post Tonsillectomy Pain Among Egyptian Children

Tonsillectomy is one of most common performed surgical procedure in children . tonsillectomy or adenotonsillectomy have high incidence of Post operative pain , it is very important and significant problem because it can lead to decrease oral intake and dehydration

Tonsillectomy is one of the most common performed surgical procedure in children. Tonsillectomy or adenotonsillectomy have high incidence of Post operative pain incidence . There is still debate about the optimal analgesia for this common procedure , different methods have been described including intraoperative anesthetic pain regimens , adjustment of surgical technique , intraoperative local anesthetic injection and use of pharmacotherapy post operative .

The main goal of the preventive analgesia is the pain releif with minimum side effect . The objective of this study is to investigate and compare the effect of Glossopharyngeal nerve block for relief of pain on children following adenotonsillectomy .

This is prospective , double blinded , randomized study

Eligibility Criteria:
Inclusion Criteria:

* average weight is 10_50 kg
* patient is generally stable
* indication of tonsillectomy is recurrent tonsillitis
* Ability to self report pain

Exclusion Criteria:

* Hypersensitivity to bupivacaine
* Obstructive sleep apnea syndrome
* Pulmonary or cardic diseases
Citalopram vs Clomipramine vs Placebo in Recurrent Depression

citalopram and clomipramine are better than placebo in preventing new episodes of depression in patients with recurrent depression


Eligibility Criteria:
Inclusion Criteria:

* Patients with recurrent depression
* Sustained response achieved (3 consecutive monthly ratings at the HDS below 13)after a treatment requiring index episode

Exclusion Criteria:

* Contraindications to study medications
* Pregnancy
* Substance abuse
A Safety and Efficacy Study of NS2 in Patients With Anterior Uveitis

This is a randomized, multi-center, investigator masked, comparator controlled study. The purpose of this study is to determine the efficacy and safety of NS2 in patients with non-infectious acute anterior uveitis. Subjects will be randomized 1:1:1 to receive multiple doses of NS2 0.5%, NS2 0.5% and Pred Forte® 1%, or Pred Forte® 1%.

Free aldehydes are thought to be related to inflammatory diseases such as uveitis. NS2, a small molecule aldehyde trap, may decrease inflammation by lowering aldehyde levels.


Eligibility Criteria:
Inclusion Criteria:

* Non-infectious anterior uveitis
* Grade 1 - Grade 3 anterior chamber cell count
* Subjects must have Intraocular pressure \<25 mmHg at baseline and may only administer a maximum of 1 topical medication to control Intraocular pressure in the study eye.
* Visual acuity ≥ 20/200 in the study eye

Exclusion Criteria:

* Severe/serious ocular pathology
* Active intermediate or posterior uveitis.
* Previous anterior uveitis episode in the study eye within 4 weeks of Visit 1
* Oral corticosteroids within 14 days of Visit 1
* Intravitreal or sub-Tenon corticosteroid treatment in the study eye within the past 6 months.
Effect of Protein and Prebiotic Fiber Intake on Adiposity in Overweight and Obese Adults

The metabolic syndrome is rising worldwide as a consequence of the continued obesity epidemic. The current obesogenic environment makes the regulation of energy intake difficult and impedes the maintenance of weight loss. Dietary patterns and/or ingredients that curb hunger and reduce energy intake are critically needed. We hypothesize that inclusion of protein and prebiotic fiber in the diet will reduce adiposity in overweight and obesity adults.

The main objective of our study is to assess the effects of protein and prebiotic fiber intake on changes in adiposity in an overweight and obese adult population.

Primary objective - To determine the effect of 12 week protein (10 g/day) or prebiotic fiber (16 g/day) intake on changes in body composition, chiefly body fat.

Secondary objective - To measure changes in appetite following 12 weeks of protein (10 g/day) or prebiotic fiber (16 g/day) intake.

Other outcomes includes changes in quality of life ratings and gut microbiota.

Eligibility Criteria:
Inclusion Criteria:

* Males and females
* Age 18 - 70 years
* BMI 25 - 38 kg/m-2
* Stable body weight for at least 3 months prior to the study

Exclusion Criteria:

* Type 1 diabetes
* Clinically significant cardiovascular, liver or pancreas disease
* Major gastrointestinal surgeries
* Pregnant or lactating
* Concomitant use of any weight loss medication, diet or exercise regime
* Antibiotic use in the preceding 3 months to enrollment
* Weight loss \> 3 kg within preceding 3 months to enrollment
* Use of bulk laxatives, fiber supplements or probiotic/prebiotic supplements
Communicating Risk Information for Obesity

This study will examine the impact of providing genetic risk information for obesity on people's attitudes and beliefs about obesity, health behaviors and weight outcomes. Specifically, this study will examine the feasibility of using genetic information to motivate efforts to reduce obesity among individuals recruited to the Coriell Personalized Medicine Collaborative (CPMC), see below for description of CPMC.

The investigators will conduct a randomized controlled feasibility trial to examine the short-term impact of personalized risk feedback for obesity. This study is uniquely situated to provide important data on how individuals interpret various sources of risk information and how they arrive at an overall perception of risk for a condition. Taken altogether, study findings will be used to serve as an overall model for future intervention efforts to effectively communicate obesity risk information with the goal of improving weight management and overall population health.

CPMC-The CPMC is an ongoing evidence-based longitudinal research study designed to determine the utility of using personal genome information in health management and clinical decision-making. They collect saliva samples, perform genetic analysis and provide genetic risk feedback for several disease conditions including coronary artery disease and type 2 diabetes. The present study will build upon the existing genetic testing and web feedback infrastructure at Coriell to conduct behavioral science research to address critical public health questions.

Eligibility Criteria:
Inclusion Criteria:

Must be age 18 or older, active enrollees in the CPMC trial, and able to read and write in English.

Exclusion Criteria:

Individuals that do not meet the inclusion criteria.
Immediate Implant Placement With Sticky Tooth Versus Autogenous Tooth Graft In Cases With Labial Plate Dehiscence

Evaluation of Soft and Hard Tissue Changes After Immediate Implant Placement With Sticky Tooth Versus Autogenous Tooth Graft for management of Cases With Labial Plate Dehiscence

In patients with labial plate dehiscence in the esthetic zone, there is no difference between the use of tooth-derived granules in combination with platelet-rich fibrin ("sticky tooth") and autogenous tooth graft in conjunction with immediate implant placement in enhancing the amount of bone labial to the implant

Eligibility Criteria:
Inclusion Criteria:

* Non-restorable teeth in the esthetic zone with a defect of labial bone.

  * Teeth with no acute inflammation.
  * Patients are free from any systemic condition that may affect the healing.
  * Availability of bone apical and palatal to the socket to provide primary stability
  * Good oral health.
  * Willingness to sign the informed consent form.

Exclusion Criteria:

* Heavy smoker (\> 10 cigarettes/day)
* Pregnant females
* Contraindication for Implant surgery.
* Patients with poor oral hygiene.
* Acute inflammation in the site of implantation and adjacent tissue.
* A history of radiotherapy in the head or neck region.
* Patients with systemic diseases like uncontrolled diabetes mellitus, coagulation disorders, alcohol or drug abuse not suitable for implantation