cyrilzakka/clinical-trials huggingface dataset:
Chrononutrition and Adolescent Weight Control

Comprehensive lifestyle interventions are recommended for the treatment of adolescent obesity; however, evidence suggests that they are not as effective in teens as they are in children and adults. Recent evidence supports that shifting the timing of energy intake earlier in the day has led to improved weight loss outcomes among adults with overweight and obesity. Given that adolescents traditionally consume the majority of their daily energy intake late in the day (past 5PM), this approach may improve the effectiveness of traditional behavioral weight control interventions in teens. Therefore, the primary aim of the proposed research is to pilot a novel adaptation of an evidence-based adolescent weight control intervention in which adolescents will be randomized to consume the majority of their daily energy needs earlier versus later in the day. More specifically, 40 adolescents, ages 13-17, with obesity (BMI\>95% for age and sex) will be randomized to a 16-week evidence-based weight control intervention that has the participant consume \>50 percent of their total energy intake before 3PM (i.e. at breakfast / lunch; BFL) or after 3PM (i.e. dinner; DIN). Assessments will take place at baseline and 16 weeks (post-treatment). The proposed study will test 1) the adherence and feasibility of the BFL vs. DIN interventions as measured by the average number of days on which daily energy was consumed in accordance with the prescribed eating plan and, secondarily, mean session attendance, 2) if the BFL group will have significantly greater reductions in BMI post-treatment as compared to the DIN group, 3) if there are differences in sleep duration and quality between groups, and finally, as an exploratory aim, whether there are differences in dietary quality between groups. The proposed research is significant, as it addresses obesity in teens. It is innovative as the timing of meals and snacks have not been manipulated in adolescents in the context of behavioral weight control. Moreover, the study will shed light on whether doing so improves sleep and could help to untangle how sleep and weight gain relate in adolescents.


Eligibility Criteria:
Inclusion Criteria:

* Age 13- 17 years
* BMI \> 85th percentile for age and sex
* Ability to speak, read and write English due to the group format of the intervention
* A caregiver who is willing to participate in four separate parent groups with a facilitator
* Agreement to study participation and random assignment.

Exclusion Criteria:

* Current involvement in another weight loss program or has lost 10 pounds in the six months prior to enrollment
* Medical condition that interferes with the prescribed dietary plan or participation in physical activity (e.g. cardiovascular disease, type 1 or 2 diabetes mellitus, or pregnancy)
* In treatment for or are diagnosed with a major psychiatric disorder, including an eating disorder, at the time of screening
* Taking medications that promote weight gain.
Central Blood Pressure Over 24 Hours (ABPM) and Left Ventricular Mass

The investigators aim to investigate whether central systolic blood pressure, as measured during regular 24 hour ambulatory blood pressure monitoring (ABPM), is a better predictor of left ventricular mass than peripheral systolic blood pressure during ABPM.

It seems obvious that central blood pressures are pathophysiologically more relevant than peripheral blood pressures for the pathogenesis of cardiovascular disease: it is central systolic pressure (cSBP) against the heart ejects (afterload), and it is central pulse pressure (cPP) that distends the large elastic arteries. Indeed, cSBP and cPP have been associated more closely with left ventricular hypertrophy and carotid atherosclerosis as markers of hypertensive end-organ damage than brachial pressures in various populations. However, in these studies office blood pressure measurements have been used. As ABPM measurements per se show a closer association with hypertensive end-organ damage than office measurements, and as the investigators have recently developed and validated a novel algorithm (ARCSolver) to calculate central blood pressures from peripheral waveforms, the investigators speculate that cSBP measured during ABPM may be the best predictor of left ventricular mass.

Eligibility Criteria:
Inclusion Criteria:

\> 18 years of age,

* no intake of antihypertensive medications
* should have an indication for ABPM (suspected arterial hypertension)

Exclusion Criteria:

* no written informed consent
* left ventricular hypertrophy due to other reasons than hypertension (hypertrophic cardiomyopathy, infiltrative cardiomyopathy, valvular heart disease, congenital heart disease)
* inability to provide adequate echocardiographic readings
* segmental contraction abnormalities of the left ventricle
* contraindications for ABPM (lymphedema both arms)
* other rhythm than stable sinus rhythm
* unstable clinical condition, including recent severe infections
A Clinical Trial to Evaluate the Efficacy of the Morley Medical Sepsis (MMS) Software Device in Predicting Sepsis in Adult Patients Using Artificial Intelligence (AI) Machine Learning Algorithms

This is a pivotal medical device clinical trial evaluating the clinical outcomes in hospitalized patients monitored with the Morley Medical Sepsis Software Device. The device uses unique AI machine learning algorithms to analyze patient data in real time and generate clinical decision support sepsis risk predictions for clinicians.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patient 18 years of age or older
* Patient is admitted or had been admitted to a participating healthcare facility

Exclusion Criteria:

* Sepsis diagnosis present on admission
* Involvement in a clinical trial of another investigational product with similar purpose
A Study of RDEA806 in Hyperuricemic Subjects With Symptomatic Gout

The purpose of this study is to determine whether RDEA806 is effective in the treatment of hyperuricemia in gout patients.


Eligibility Criteria:
Inclusion Criteria:

* Patient is hyperuricemic: screening serum uric acid ≥8 mg/dL.
* Patient meets one or more of the 1977 ARA criteria for the diagnosis of gout.
* Patient is willing and able to give informed consent and adhere to visit/protocol schedules
* All female subjects of child-bearing potential must agree to use a barrier method of birth control (e.g. condom, diaphragm or cap).

Exclusion Criteria:

* Consumes more than 14 drinks of alcohol per week.
* History or suspicion of drug abuse.
* History of kidney stones, rheumatoid arthritis or other autoimmune disease, significant cardiac dysfunction.
* Diabetes Mellitus requiring treatment
* Confirmed or suspected HIV-1 infection.
* Malignancy, except treated non-melanomatous skin cancer and cervical dysplasia.
* Uncontrolled hypertension.
* Inadequate renal function.
* Hemoglobin \< 8 g/dL (males) or \< 7 g/dL (females).
* ALT, AST , or GGT 2 x ULN
* Active peptic ulcer disease.
* Requires long-term use of salicylates; thiazide diuretics; losartan; azathioprine; mercaptopurine; theophylline; IV colchicine; cyclosporine; cyclophosphamide; pyrazinamide; sulfamethoxazole; trimethoprim.
* Pregnant or breast feeding.
* Use of an investigational drug within 4 weeks prior to study drug administration.
* Known hypersensitivity or allergy to RDEA806 or colchicine or any components in their formulations.
* Any other medical or psychological condition which, in the opinion of the investigator, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements, or to complete the study.
* History of cardiac abnormalities including abnormal and clinically relevant ECG changes.
* Conditions predisposing to QT prolongation.
* Any use of concomitant medications that prolong the QT/QTc interval within 14 days prior to Day 1.
* Subjects with a QTcF interval \>450 milliseconds at screening or on Day -1 or at pre-dose (Hour 0) on Day 1.
Efficacy & Safety of TD-1473 in Ulcerative Colitis

A Phase 2b/3 set of studies to evaluate the efficacy and safety of induction and maintenance therapy with TD-1473 in subjects with moderately-to-severely active ulcerative colitis with up to 60 weeks of treatment.

This protocol consists of 3 separate studies: an 8-week Phase 2b dose-finding induction study, an 8-week dose-confirming Phase 3 induction study, and a 44-week Phase 3 maintenance study. Subjects who respond to induction will enter the maintenance study; those who do not will receive TD-1473 during extended induction. The safety and efficacy data of the Phase 2b study will be analyzed to select the induction and maintenance dose regimens for the confirmatory Phase 3 studies. Participants who have disease relapse or complete the maintenance study may be eligible to enter a separate long-term safety study. Efficacy, pharmacokinetic, biomarkers, and safety will be evaluated in all 3 studies.

240 subjects are planned for the Phase 2b and the planned Primary Completion Date for this portion of the study is JULY 2021. 640 subjects are planned for the Phase 3 portion of the study.

Eligibility Criteria:
Inclusion Criteria:

* Is at least 18 years of age at screening
* Has a history of UC for at least 3 months prior to screening
* Has moderately-to-severely active UC, as defined by a Mayo endoscopic subscore of ≥2 points and an adapted Mayo score between 4 - 9 points inclusive
* Is corticosteroid-dependent or has demonstrated inadequate response, or intolerance to conventional therapy (aminosalicylates, corticosteroids, immunomodulators) or biologics
* Willing to use highly-effective methods of contraception during the study and for 7 days after the last dose
* Additional inclusion criteria apply

Exclusion Criteria:

* Has symptoms suggestive of fulminant colitis, megacolon or intestinal perforation
* Likely to require surgery for UC or other major surgeries
* Has previously received / is currently receiving prohibited medications within specified timeframe
* Is refractory to 3 biologics with ≥2 mechanisms of action
* Has a current bacterial, parasitic, fungal, or viral infection
* Has clinically significant abnormalities in laboratory evaluations
* Has had any prior exposure to an approved Janus kinase (JAK) inhibitor or potential exposure to an investigational JAK inhibitor that was stopped due to intolerance or lack of efficacy
* Additional exclusion criteria apply
Early Infant Diagnosis Point of Care Pilot

In Mozambique, early infant HIV diagnosis (EID, i.e. HIV screening of infants under 18 months of age) is conducted using molecular diagnostics at central laboratories in Maputo, Nampula, Beira and Quelimane. However, test volumes are growing and many parts of the country do not have close access to laboratories. Test samples are transported over large distances and this can introduce testing delays, especially for patients in rural and remote areas of the country. There are now new POC EID technologies becoming available that will enable diagnosis of HIV in infants within minutes or a couple of hours on site in the clinic, operated by non technical staff and without laboratory infrastructure. This protocol describes a plan to conduct an evaluation of a Point-Of-Care (POC) Early Infant Diagnosis (EID) testing technologies that are being considered for use in Mozambique, and to pilot those technologies in order to provide more effective diagnostics and clinical care to patients. During this implementation pilot, sites are randomized to use either conventional or POC EID testing only before the inclusion of the patients in the study. No consent will be asked to the parents or guardians. A written permission will be asked to the Direção Provincial de Saúde of both provinces to implement the POC device as routine in those intervention sites. All the information that will be analyzed will be collected from the routine care and it will be analyzed as a group.


Eligibility Criteria:
Inclusion Criteria:

* Born to HIV positive mother
* From 4 weeks to 18 months of age
* Came to CCR consultation for Early Infant Diagnosis

Exclusion Criteria:

* With a valid positive test by other center
Evaluation of a Novel Endoscopic Treatment for Achalasia

This study is to evaluate outcomes of a less invasive surgical procedure for the treatment of achalasia.

This study will assess the feasibility and efficacy of a novel endoscopic procedure, Per-oral Endoscopic Esophagomyotomy (POEM)in treating patients with achalasia.

Eligibility Criteria:
Inclusion Criteria:

* o Subjects with a manometric/radiologic diagnosis of primary achalasia; EGD shows no neoplasm

  * Ability to undergo general anesthesia
  * The subject is \> 18 yrs.of age
  * Ability to give informed consent

Exclusion Criteria:

* o Sigmoid achalasia

  * Contraindicated for EGD
  * Pregnancy
Progressive Esophageal Dilation for Benign Strictures: a Randomized Controlled Trial

A randomized controlled prospective clinical trial assessing the efficacy and safety of progressive esophageal dilation compared to conservative esophageal dilation in patients with severe benign esophageal strictures.

A randomized controlled prospective clinical trial assessing the efficacy and safety of progressive esophageal dilation (up to 6mm) compared to esophageal dilation according to the rule-of-3 in patients with severe benign esophageal strictures. Patients will be followed up for 6 months. When recurrent dysphagia occurs within 6 months the patients will be dilated according to the previously allocated strategy.

Eligibility Criteria:
Inclusion Criteria:

* Dysphagia due to benign esophageal stricture (e.g. surgery, radiation therapy, caustic ingestion, peptic injury, photodynamic therapy) requiring esophageal dilation
* Requiring first esophageal dilation for dysphagia due to a severe benign esophageal stricture with no patency for standard upper endoscope (9-10mm diameter)
* No history of esophageal endoscopic dilations for benign strictures the past 6 months
* Dysphagia for solid, semisolid or liquid food (dysphagia score ≥ 2 \[Ogilvie\]16, and dysphagia score ≤ 21 \[Dakkak and Bennett\]19, see appendix)
* Written informed consent

Exclusion Criteria:

* Patient \< 18 years old
* Patient is unwilling or unable to sign and date the informed consent
* Patient is unwilling or unable to comply with the follow-up schedule
* Patient is unable to understand informed consent and fill in the questionnaires due to a language barrier
* Patient is pregnant, breast-feeding, or planning to become pregnant in the next 12 month
* Patient is simultaneously participating in another drug or device study or the patient has completed the follow-up phase for the primary objective of any previous study less than 30 days prior to enrollment in this study
* Previous esophageal dilation for benign stricture within the past 6 months
* Patient with a life expectancy \< 12 months
* Patient with a known eosinophilic esophagitis or motility disorder (such as achalasia)
* Patients with a known malignant esophageal stricture
* Patients with a benign stricture due to a previous performed laryngectomy

Endoscopic exclusion criteria:

* Benign strictures in the upper part of the esophagus too close to the cricopharyngeal muscle (for the purpose of this protocol, within 1½ cm of the upper esophageal sphincter)
* Patients with stricture ≥ 10 cm in length
* Patients with an active esophageal perforation, leak, fistula, or varices
* Stricture within necrotic chronically bleeding tumors
* Highly suspected esophageal malignancy
* Stricture within polypoid lesions
* Known or strongly suspected dysmotility esophageal disorder
* Patient with high suspicion for an esophageal web, Schatzki ring, eosinophilic esophagitis, or motility disorder (such as achalasia)
Expanded Access Program (EAP) STIMULAN VG

Individual (single) patient expanded access may be considered.

Patients facing serious or life-threatening illnesses who have exhausted currently available treatment options and are ineligible or unable to participate in a clinical trial may decide to explore therapeutic use of investigational drugs with their healthcare providers.

Under these circumstances, single-patient access can be requested from a licensed treating physician on behalf of the patient.

Please contact expandedaccess@biocomposites.com for more information.

Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

-
Rapid Orocecal Transit Time and Fermentation in IBS.

Orocecal transit time is studied in individuals with irritable bowel syndrome (IBS) of both the constipation-dominant, diarrhea-dominant, and mixed form using the lactulose hydrogen breath test for orocecal transit time through the gut. Data are compared to those of healthy volunteers. The peak value of fermentation as read by hydrogen levels is captured after passage of the orocecal segment in the colon. Comparison are made between IBS patients and healthy subjects as regards orocecal transit time and peak fermentation in the cecum.

Patients with IBS of various kind (constipation-dominant, diarrhea-dominant, and mixed form) in large numbers are studied as regards orocecal transit time and compared to healthy controls.

Inclusion criteria: IBS patients 18-80 years old, diagnosis of IBS; exclusion: Severe cardiac, pulmonary, liver or kidney disease, bloody stool After fasting for 12 hours, all subjects ingest 10 grams of lactulose. Hydrogen production, measured as hydrogen concentration in breath, is estimated at 10-minute intervals for a period of 240 minutes. The orocecal transit transit time is measured from ingestion of the lactulose solution until hydrogen peaks to 10 and 20 ppm when passing the ileocecal valve, being fermented by the cecal microflora. Data are compared to those of healthy volunteers.

The peak value of fermentation as read by hydrogen levels (ppm) captured after passage of the ilecocecal valve orocecal valve signifies the gas production of the micro13flora. Comparison are made between IBS patients and healthy subjects as regards orocecal transit time and peak fermentation in the cecum.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects, or IBS patients or either kind (IBS-C, IBS-D, IBS-M), no concomitant medication.

Exclusion Criteria:

* Chronic disease, such cardiac, pulmonary, liver, kidney, endocrinological rheumatological, neurological or psychiatric disease plus, in addition, chronic medication.
LESCOD: "Lewy Body Screening in Cognitive Disorders"

Dementia with Lewy body (DLB) is the second most common neurodegenerative dementia in autopsy series. However, DLB represents a small proportion of the clinical diagnoses in epidemiology registries. Indeed Alzheimer disease (AD) and DLB are often concomitant, they share many symptoms and only a small weight is given to non-motor symptoms in DLB diagnosis. DLB is at the end of a pathological spectrum overlapping with AD, explaining the poor diagnostic value of both diagnostic criteria. To date there is still a need for a tool able to discriminate patients with pure DLB from those expressing common signs with both AD and DLB and those with pure AD. The purpose of this study is to validate a semi quantitative scale designed to reflect the Lewy Bodies burden in patients with mild to moderate cognitive decline. The investigators hypothesized that the score obtained may differentiate between AD, DLB and patients fulfilling clinical criteria for both DLB an AD. This score could also be correlated with dopaminergic depletion assessed with \[18F\]fluorodopa PET/computed tomography and/or with potential biomarkers of ADD measured in cerebrospinal fluid. This clinical validation is a preliminary work preceding further studies correlating the LeSCoD score with functional imaging features, prognosis and therapeutic response. Thus, the expected outcomes involve an improvement in demented patients' care, as well as a better patient selection for further therapeutic studies


Eligibility Criteria:
Inclusion Criteria:

* Be a woman or a male \>60 to \< 90 years
* Have sufficient visual and auditory acuity
* Be able to speak, read, hear and understand french language
* Be covered by health care insurance
* Have a reliable help/partner/informant/caregiver
* Have a mild to severe cognitive decline based on MMSE (Mini-Mental State Examination) score ( From 18 to 26)
* Give oral agreement to the assessment of the LEsCoD scale during routine consultation
* Have performed neuropsychology tests and MRI respectively within 6 and 12 months

Exclusion Criteria:

* Has evidence of neurological or psychiatric disorder other than AD or DLB explaining cognitive decline
* Has received previously or currently neuroleptic treatment
* Has no reliable help/caregiver the day of the visit
* Refuses to give his/her oral agreement to the assessment of the LeSCoD scale
* Has presence on MRI of radiologic evidence of cerebrovascular disease (score Fazekas 2)
Esophageal Calibration During Laparoscopic Fundoplication Reduces Dysphagia

Gastro esophageal reflux is the most common benign disease of the esophagus and Laparoscopic Nissen fundoplication became the standard surgical treatment of this disease. Although being almost transient postoperative dysphagia is still a common complaint following this procedure. The aim of this study is to investigate the effect of inserting a soft structured and blunt mounted 39 F orogastric tube to postoperative dysphagia.


Eligibility Criteria:
Inclusion Criteria:

* Grade 3 or more esophagitis
* Hiatal hernia larger than 3 centimeters
* Acide suppression therapy history longer than 2 years

Exclusion Criteria:

* Story of endoscopic mucosal resection for Barret's mucosa
DAPROCA Pelvic Lymph Node Irradiation to Prostate for High Risk Prostate Cancer: Phase I/II Study

This is a prospective, open label 1 arm study, multicentre, Phase I/II clinical safety study. The trial is designed to gain initial safety and efficacy data on pelvic lymph node radiation with simultaneous integrated boost to prostate in high risk prostate cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* adenocarcinoma
* T3 tumor and either Gleason 8-10 and PSA ≤ 70,or PSA ≥ 30 and PSA ≤ 70, or T1-T3 and PSA ≤ 70 and N1
* no distant metastases

Exclusion Criteria:

* pelvic co-morbidity such as Crohns disease or ulcerative colitis
* uncontrolled heart or lung morbidity
* prior radiation treatment of pelvic region
* age \> 75 years