cyrilzakka/clinical-trials huggingface dataset:
Families on Track: A Digital Health Behavioral Intervention for Parents Seeking Treatment for Their Child With Obesity

Current models of outpatient childhood obesity treatment focus on the child's health habits, with limited efficacy. In part, this may be because childhood obesity is highly sensitive to parental lifestyle habits, who are often not a direct target of child obesity interventions. This study aims to target weight loss among overweight parents of 2-16 year old children with obesity enrolled in the Duke Healthy Lifestyles Program (HL) in order to augment child body mass index reduction. The intervention, " Families on Track" is a digital health intervention platform using the Interactive Obesity Treatment Approach (iOTA).

Parents in the program will receive the family-based treatment protocol provided by the Healthy Lifestyles clinic. First, families attend a half-day session at the clinic where child anthropometrics and labs are obtained, and nutrition and physical activity group counseling is provided. Height and weight of the primary adult caregiver are measured and BMI is calculated. Second, families return 2 weeks later to meet individually with a pediatric obesity medical provider and a registered dietitian. Thereafter, frequency of visits is determined based on the families needs with a final visit 1 year after starting treatment. The ideal is to have visits with the HL staff at intervals of 4-6 weeks for 5 more visits to complete the primary phase of the program over 6 months.

Parents enrolled in the study will also receive the Track intervention. The investigators will use a modified version of the Track intervention, which utilized the Interactive Obesity Treatment Approach (iOTA). iOTA uses a computer algorithm to assign 3-4 personalized behavioral goals known to create an energy deficit to produce weight loss (e.g., sugary drinks, fast food consumption walk 10,000 steps/day, etc). The team at Duke Digital Health has shown that iOTA can be successfully delivered to adults on multiple modalities -- web, text messaging and interactive voice response phone calls. Each week, participants will receive a prompt from the Track intervention system in order to self-monitoring these behaviors goals. These prompts will be delivered either via interactive voice response or text message. Intervention participants will also receive an analog bathroom scale and a pedometer to self-monitor daily weights and steps.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18-60 years
* BMI: 25-50 kg/m2
* English speaking
* Mobile phone ownership
* Willingness to send and receive multiple text messages/day
* living in the same household as a Healthy Lifestyles patient ages 2-16

Exclusion Criteria:

* Current pregnancy or lactation
* Prior or planned bariatric surgery Both child and parent participation in other obesity trials - including the evaluation of the Bull City Fit Program at the Healthy Lifestyles program
* History of heart attack, stroke, bipolar disorder schizophrenia or recent cancer diagnosis
* Plans to relocate within 1 year
Does Hemodialysis Affect Upper Extremity Functional Capacity, Physical Activity and Physical Function of Patients?

This study was planned to determine the effects of upper extremity functional capacity, physical activity level and physical functions of patients receiving hemodialysis treatment.

Upper extremity functional capacity, physical activity level and physical functions were evaluated in healthy subjects and hemodialysis patients.

Eligibility Criteria:
Inclusion criteria:

In study group,

* with cooperation
* hemodialysis treatment for at least 3 months
* with single-sided fistula

In the control group,

* healthy volunteers with no history of trauma or surgery in the upper extremity,
* with cooperating

Exclusion Criteria:

* Individuals with orthopedic problems associated with chronic renal failure,
* Upper limb functions affected
Portal Vein Pulsatility Flow in Pregnancy

This study is to investigate if portal vein pulsatility fraction can be measured in pregnancy and if it increases during the course of pregnancy as would be expected by the physiologic increase in blood volume that happens during pregnancy. Portal vein pulsatility fraction is measured in non-pregnant controls and in women in the 1st, 2nd and 3rd trimester of pregnancy.


Eligibility Criteria:
Inclusion Criteria:

* Ability to give informed consent
* American Society of Anesthesiologists (ASA) Class I and II
* Singleton pregnancy during 1st, 2nd or 3rd trimester or healthy non-pregnant females of childbearing age as controls

Exclusion Criteria:

* Inability to give informed consent
* Multiple gestation
* Significant co-morbidities (e.g. cardiac abnormalities, cardiac dysfunction, arrhythmias, severe asthma, renal insufficiency)
* High risk pregnancies (e.g. pre-eclampsia, gestational hypertension, HELLP, gestational diabetes)
* Body-Mass-Index (BMI) \< 18kg/m2 or \>40kg/m2
The Role of Small Intestinal Endocrine Cells in Type 2 Diabetic Hyperglucagonemia

The purpose of this study is to determine whether excessive secretion of glucagon in type 2 diabetes originates from the pancreatic alpha-cells or endocrine cells in the mucosa of the small intestinal.

Hyperglucagonemia contributes significantly to the hyperglycemia characterizing patients with Type 2 diabetes. Fasting hyperglucagonemia induces hepatic glucose release resulting in elevated fasting levels of plasma glucose. Furthermore, lack of postprandial suppression of glucagon secretion - exchanged for a paradoxical postprandial hypersecretion of glucagon - results in increased levels of postprandial plasma glucose. Additionally, type 2 diabetes is characterized by decreased postprandial responses of the insulinotropic (and glucagonostatic) peptide hormone glucagon-like peptide-1 (GLP-1). Recent studies from our group suggest that the intestines are involved in the diminshed suppression of glucagon following ingestion of nutrients. Thus, suppression of glucagon during oral glucose ingestion diminishes and reverses to stimulation while suppression during intravenous administered glucose sustains along with development of glucose intolerance. In the small intestines mucosal endocrine L-cells secrete GLP-1, which is processed from its precursor, proglucagon, by prohormone convertase 1 (PC1). In the pancreatic alpha-cells proglucagon is processed to glucagon via prohormone convertase 2 (PC2). We plan to examine biopsies from the mucosa of the small intestines from patients with type 2 diabetes and from healthy subjects for glucagon production. Furthermore, the volunteers will be subjected to a standard meal test in order to correlate the gene expression studies with the level of postprandial hyperglucagonemia of the subjects.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with type 2 diabetes for at least 3 months
* Normal hemoglobin
* Informed consent

Exclusion Criteria:

* Liver disease (ALAT/ASAT \> 2 x normal range)
* Diabetic nephropathy (se-creatinin \> 130 µM and/or albuminuriu)
* Treatment with medication that can not be stopped for12 hours
Buccal Cancer Resection Ultrasound Guided

The aim of this research is to decrease the number of inadequate tumor-free margins, probably resulting in less adjuvant therapy, less local recurrences and better quality of life.

Buccal mucosa cancer is a rare disease. In the Netherlands, approximately 100 patients are treated for this disease each year. To obtain good local control, it is important that the histological distance from the tumor to the resection plane is 5 mm or more (tumor-free margin). If the tumor-free margin is smaller, such as close (1-5 mm) or involved (\<1 mm) margins, there is usually an indication for adjuvant therapy. Now, the tumor-free margins in buccal mucosa cancer are often insufficient, so that a significant proportion of patients require adjuvant treatment (re-resection or radiotherapy). Postoperative radiotherapy can greatly reduce the quality of life due to the development of, for example, osteoradionecrosis, mucositis and fibrosis. During a re-resection it is often difficult to find the location of the insufficient margin. Ultrasound-guided resection can be used to visualize the tumor during surgery, in order to improve the tumor-free margins. Currently, the tumor-free margin is only estimated palpably and frozen sections are sometimes used in case of doubt.

The aim of this research is to decrease the number of involved margins, probably resulting in less adjuvant therapy, less local recurrences, and better quality of life.

In this trial, 50 patients with a squamous cell carcinoma of the buccal mucosa will be included for treatment with ultrasound-guided resection.

50 patients with a squamous cell carcinoma of the buccal mucosa, who will be treated with surgery under general anesthesia, will be included in this study. The tumor has to be visible as an hypo-echogenic region on the ultrasound.

Eligibility Criteria:
Inclusion Criteria:

* buccal mucosal squamous cell carcinoma
* surgical removal under general anesthesia

Exclusion Criteria:

* tumor is not visible on ultrasound as echolucent region
Reliability and Validity of the Turkish Version of the GCPS 2.0.(Graded Chronic Pain Scale 2.0)

This study was designed to conduct Turkish adaptation, cross-cultural adaptation, validity, and reliability study of Graded Chronic Pain Scale 2.0 in order to use it for Turkish people with Chronic Pain.

The GCPS 2.0 is an eight-item scale that evaluates the severity of chronic pain, the presence of persistent pain due to pain days, and the degree of disability due to pain. It is easy, simple, useful and multidimensional. 80 volunteer participants who had chronic low back pain were studied.The data collection tools used in this study were; Clinic and Demographic Evaluation Form, Oswestry Low Back Pain Disability Index, Patterns of Activity Measure Pain, Roland-Morris Disability Questionnaire, Hospital Anxiety, and Depression Scale, and Graded Chronic Pain Scale 2.0. In this study, the forms were sent by e-mail. The Snowball sampling method was used in the data collection process.The stages of the Beaton Protocol were followed in the translation of the scale. Validity was evaluated with the Face, Content, and Construct validity analyses. Exploratory and confirmatory factor analyses were applied to determine the construct validity of the Turkish version of the scale. Reliability was evaluated with the test-retest method, the parallel forms method, and the internal consistency. Ten days after completing the scale, 30 participants filled out the scale again for the Test-retest method. One of the scales we used for the parallel forms method was RMDQ and the other was ODI.

Eligibility Criteria:
Inclusion Criteria:

Participants were Turkish speakers and volunteer participants aged 18 years and over and under 70 years of age who had recurrent or persistent chronic LBP for 6 months or more.The following participants with CLBP diagnosed by a physician were included in the study. These;

* Disc herniations
* Mechanical back pain
* Lumbar strain
* Spondylolisthesis
* Degenerative disc disease
* Muscle imbalance
* Lumbago
* A trigger point in the back muscles

Exclusion Criteria:

* Having a history of illness such as Psychiatric disorder, Cognitive impairment, Dementia, or Alzheimer's
* Low back pain that needs immediate treatment (neoplasm, cauda equina syndrome, infection, fracture)
* Inflammatory low back pain
* Low back pain due to a vascular cause
Evaluation of Omeprazole Effect on Glaucoma

Omeprazole is a safe drug listed in OTC drug due to its safety. It acts by irreversible inhibition of K/H ATP ase pump and also Na/K ATP ase, Na/H ATP ase.Considering these actions the effect of omeprazole on decreasing intra ocular pressure is an issue of debate.In this Randomized Clinical Trial conducted in labafinejad hospital, patients with glaucoma who need to take omeprazole due to GI problem are evaluated in two groups including placebo and drug users. The effect will be finally assessed.

Omeprazole is a safe drug listed in OTC drug due to its safety. It acts by irreversible inhibition of K/H ATP ase pump and also Na/K ATP ase, Na/H ATP ase.Considering these actions the effect of omeprazole on decreasing intra ocular pressure is an issue of debate.In this Randomized Clinical Trial conducted in labafinejad hospital, patients with glaucoma who need to take omeprazole due to GI problem are evaluated in two groups including placebo and drug users. The effect will be finally assessed.

Eligibility Criteria:
Inclusion Criteria:

* patients with glaucoma
* 18 to 70 years
* POAG patients, Pseudoexfoliation
* no history of other systemic disease
* no history of intraocular intervention
* no history of H2 blocker or PPI consumption during the past month consuming 2 or less topical anti-glaucoma medication
* no present immune deficiency
* no addiction habit

Exclusion Criteria:
A Study to Learn How Safe and Tolerable Odronextamab and Cemiplimab Are in Adult Patients With B-cell Malignancies

This study is researching a combination of 2 experimental drugs, referred to as "study drugs", called odronextamab (also known as REGN1979) and cemiplimab (also known as REGN2810). The study is focused on patients who have relapse/refractory aggressive B-cell lymphoma. The aim of the study is to see how safe and tolerable the study drugs are, and to define the recommended dose regimen for the combination with odronextamab.

This study is also looking at several other research questions, including:

* What side effects may happen from taking the study drugs
* How effective the study drugs are against the disease
* How much study drug is in the blood at different times
* Whether the body makes substances or protein called antibodies against the study drugs (that could make the drugs less effective or could lead to side effects)


Eligibility Criteria:
Key Inclusion Criteria:

1. Have documented CD20+ aggressive B-cell NHL that is either not responsive to or relapsed after at least 2 prior lines of systemic therapy, for whom treatment with an anti-CD20 antibody may be appropriate. In addition, prior treatments should at least contain an anti-CD20 antibody and an alkylating agent.
2. Must have at least 1 nodal lesion (≥1.5 cm), or at least one extranodal lesion with longest transverse diameter (LDi) greater than 1.0 cm, documented by diagnostic imaging (computed tomography \[CT\] or magnetic resonance imaging \[MRI\]).
3. Eastern Cooperative Oncology Group (ECOG) performance status ≤1
4. Adequate bone marrow and hepatic function, as defined in the protocol
5. Willing and able to comply with clinic visits and study-related procedures
6. Provide signed informed consent

Key Exclusion Criteria:

1. Primary central nervous system (CNS) lymphoma, or known or suspected CNS involvement by non-primary CNS NHL
2. History of or current relevant CNS pathology, as described in the protocol
3. Ongoing or recent (within 2 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-mediated adverse events (iAEs)
4. Prior therapies, as described in the protocol
5. Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection or other uncontrolled infection
6. Cytomegalovirus infection as noted by detectable levels on peripheral blood polymerase chain reaction (PCR) assay until the infection is well controlled.
7. Known hypersensitivity to both allopurinol and rasburicase
8. Pregnant or breastfeeding women
9. Women of childbearing potential, or men who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 6 months after the last dose, as defined in the protocol
10. Patients prior diagnosis of hemophagocytic lymphohistiocytosis (HLH) or macrophage activation syndrome (MAS)

Note: Other protocol-defined Inclusion/Exclusion criteria apply
A Comparison of Changes in Bone Density With the Same Bone-health Plan, But With Different Bone-health Supplements

A comparison of changes in bone density following the same bone-health plan, but with a different bone-health supplement.

The US Surgeon General's Report on Bone Health suggests America's bone-health is in jeopardy and issued a "call to action" to develop bone-health plans that:

1. improve nutrition,
2. increase health literacy and,
3. increase physical activity.

The purpose of this study was to use a comparative effective research model to compare 6-month changes in bone mineral density (BMD)in two study groups. Both followed the same bone health plan that contained the three components listed above with the same plant-source calcium supplement, but enhanced with different levels of calcium, vitamin D3, vitamin K and magnesium.

Eligibility Criteria:
Inclusion Criteria:

* All subjects were required to contact the physicians to ensure they had no medical issues that would preclude their participation.

Exclusion Criteria:

* Younger the 18 years of age, and
* Recommendations not to participate from their physicians.
Effect of High Intensity Interval Training in Patients With Multiple Sclerosis

In this study, we are aiming to systematically review the literature on the effect of HIIT on MS patients as improving physical performance, cognitive function, aerobic fitness and muscle strength. This could help guide the development of standardized clinical guidelines and direct clinical decision making by the physical therapists whether to implement this type of exercises or not.

Multiple sclerosis patients have considerably negative effects on the community and the national and international economy. Chronic symptoms of MS such as fatigue, cognitive impairments, emotional burden and diminished physical functioning considerably affect the daily lives of people with MS and may interfere with social and quality of life factors as friendships, family relationships and occupational status. HIIT has induced significant improvements in physiological conditioning in healthy and clinical populations, and might be appropriate for persons with MS. Recently, several RCTs have been published evaluating the effect of HIIT on MS patients. Consequently, this study will systematically review all these recent literature to direct the physiotherapists whether to implement this type of exercises or not.

Eligibility Criteria:
Inclusion Criteria:

* Studies: English full texts of RCTs only, Participants: multiple sclerosis patients with age from (20-50) years old irrespectively of sex, subtype of MS, race, diagnostic criteria, community or onset of the disease, Intervention: HIIT, any comparator.

Exclusion Criteria:

* Studies other than English full text RCTs, non adults younger than 20 years and older than 50 years, populations other than multiple sclerosis.
Pulmonary Vein Ablation of Atrial Fibrillation Using Magnetic Navigation: Single Ring Versus Circumferential Techniques

The single-ring ablation method aims for isolation of the posterior LA wall including the pulmonary veins. If avoiding ablation on the posterior LA wall esophageal injury is unlikely.

Aim of this prospective study was to evaluate the safety and efficacy of an RMN-guided single-ring ablation method as compared to standard RMN-guided circumferential PVA.


Eligibility Criteria:
Inclusion Criteria:

* drug refractory AF patients undergoing PVA

Exclusion Criteria:

* drug refractory AF patients undergoing repeat PVA
Soft and Hard Tissue Changes After Immediate Single-tooth Replacement

A recent systematic review (Lee et al, 2016) reported that placement of a soft tissue graft concurrent with immediate implantation may contribute to the stability of gingival level and the augmentation of soft tissue contour. However, most included studies did not have a control group to directly demonstrate the benefit of an immediate implant combined with soft tissue graft (IMITG) compared to immediate implant alone.The objective of this randomized controlled clinical trial with a parallel design is to evaluate the influence of the connective tissue graft on the buccal bone alterations after tooth extraction and immediate implant placement by means of cone beam computer tomography (CBCT).

All participants will be selected on a consecutive basis, among individuals, above the age of 18 years, referred to Dental Clinic of the San Raffaele University, with a single failing tooth in the upper and lower jaw from second premolar to second premolar, candidates for a single implant restoration. After local anesthesia, a split-full-split thickness envelope flap, as described for the treatment of multiple gingival recessions by Zucchelli and de Sanctis (2000), will be elevated and the tooth will be extracted a-traumatically. The immediate implantation procedure will be carried out according to the manufacture protocol and 1mm of the transmucosal portion of the implant will be positioned under the buccal bone crest. In the group "Implant+CTG" a connective tissue graft (CTG), resulting from the extraoral de-epithelialization with the knife blade of a free gingival graft harvested from the palate, will be anchored at the anatomic papillae with 2 horizontal mattress sutures and positioned 1 mm coronal to the buccal bone crest and in the apical direction 2 mm above the buccal crest. Patients will be followed for 6 months after implant placement and 6 months after loading.

Eligibility Criteria:
Inclusion Criteria:

* a single tooth to be extracted for endodontic failure, fractures, root caries or resorption in the maxillary and mandibular area from second premolar to second premolar
* patient in good systemic health, with no contraindication for oral surgical interventions

Exclusion Criteria:

* patients with impaired systemic diseases that will interfere with surgical interventions (autoimmune diseases, uncontrolled diabetes)
* assumption of bisphosphonate
* smoking more than 10 cigarettes a day
Cefepime/AAI101 Phase 2 Study in Hospitalized Adults With cUTI

Phase 2, randomised, double-blind, 2-cohort study in hospitalised adults with complicated urinary tract infection (cUTI), including acute pyelonephritis. All study cohorts were randomised in a 2:1 ratio. Treatment duration for each cohort was 7 to 10 days. Patients were not permitted to switch to oral therapy.

Cohort 1: 15 patients treated with cefepime 1 g/AAI101 500 mg intravenous (i.v.) infusion over 2 hours once every 8 hours (q8h), and 7 patients treated with cefepime 1 g i.v. infusion over 2 hours q8h.

Cohort 2: 15 patients treated with cefepime 2 g/AAI101 750 mg i.v. infusion over 2 hours q8h, and 8 patients treated with cefepime 2 g i.v. infusion over 2 hours q8h.


Eligibility Criteria:
Inclusion criteria:

• Male or female patients with clinical signs and/or symptoms of cUTI or acute pyelonephritis that were expected to require hospitalization and initial treatment with at least 7 days of i.v.

antibiotics.

Exclusion criteria:

* Patients with concurrent infection that would interfere with evaluation of response to the study antibiotics;
* Patients needing concomitant systemic antimicrobial agents in addition to those designated in the various study treatment groups;
* Patients receiving effective antibacterial drug therapy for any indication for a continuous duration of \>24 hours during the previous 72 hours before the study-qualifying baseline urine was obtained or receiving any amount of potentially therapeutic antibacterial therapy after collection of the pre-treatment baseline urine culture and before administration of the first dose of study drug;
* Patients likely to require the use of an antibiotic for cUTI or acute pyelonephritis prophylaxis during participation in the study;
* Patients with confirmed fungal urinary tract infection at the screening visit (with ≥103 fungal colony forming units \[CFU\]/mL); or
* Patients with intractable urinary infection at baseline that the Investigator anticipated would require \>10 days of study drug therapy were excluded from participation