cyrilzakka/clinical-trials huggingface dataset:
Diazoxide Choline in Hypertriglyceridemia

Hypertriglyceridemia affects 30% of the population in the US. Very high level of triglycerides is a known risk factor for pancreatitis. In addition, studies have shown that hypertriglyceridemia is an independent risk factor for cardiovascular disease.

Diazoxide is a KATP channel opener. It has been approved by the FDA as an oral suspension for the treatment of hyperinsulinemic hypoglycemic conditions and as an IV solution for malignant hypertension. Preclinical and clinical studies suggest that diazoxide can be a potential therapeutic agent for hypertriglyceridemia.

Diazoxide choline is a novel, highly crystalline proprietary salt of diazoxide, which has been formulated as a controlled-release tablet suitable for once per day dosing. This current study is designed to assess the effect of diazoxide choline on triglycerides in subjects with baseline hypertriglyceridemia. In addition, the effects on other lipid parameters, glucose and insulin, body weight as well as the safety and tolerability of diazoxide choline will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* triglycerides ≥ 250 mg/dL and \< 600 mg/dL
* BMI between 18.5 and 45
* Signed informed consent form

Exclusion Criteria:

* Fasting glucose ≥ 126 mg/dL
* Glycosylated hemoglobin (HbA1c) \> 6.5%
* LDL cholesterol \> 190 mg/dL
* Known history of type I and II DM
* Known history of type I and III hyperlipidemia
* Weight change \> 3 kg between screening and baseline visits
* Pregnancy or intention to become pregnant
* Presence of significant underlying conditions that may interfere with the assessments of the study drug
Treatment of High Blood Pressure Using Olmesartan With Hydrochlorothiazide Compared to an ACE Inhibitor With a Calcium Channel Blocker

A comparison of 2 different combinations of high blood pressure medications to treat hypertension


Eligibility Criteria:
Inclusion Criteria:

* Greater than 18 years of age
* Patients with high blood pressure

Exclusion Criteria:

* Hypertensive encephalopathy, stroke or transient ischemic attack within the past 6 months
* History of myocardial infarction, percutaneous transluminal coronary revascularization, coronary artery bypass graft, and/or unstable angina pectoris within the past 6 months
* Type 1 diabetes mellitus
Effect of Segmental Muscle Vibration on Upper Extremity Functional Ability Post Stroke

Background and objective: Upper extremity functional impairments are common consequences post stroke. The aim of this study was to investigate the influence of Segmental muscle vibration (SMV) application along with supervised physical therapy (SPT) on improving activities of daily living (ADL) and motor recovery on the hemiparetic upper extremity in patients with stroke.

Methods: A sample of 37 patients post stroke (29 males) was randomly assigned to either supervised physical therapy (SPT) control group (n=18) or supervised physical therapy and segmental muscle vibration (SPT-SMV) experimental group (n=19). All patients received 3 sessions per week of SPT for 8 weeks. The SPT-SMV experimental group received SMV at the end of each SPT session. Outcome measures used were Barthel Index (BI), Modified Ashworth Scale (MAS), Manual Muscle Testing (MMT), and goniometry for Range of Motion (ROM) assessment.


Eligibility Criteria:
Inclusion Criteria:

* confirmed diagnosis of stroke

Exclusion Criteria:

* if they had any serious orthopedic injury/disease, cardiopulmonary problems or suffered from a neurological disease (other than stroke).
Effects of Humidity (During CPAP Treatment) on Mucociliary Clearance in Patients With Obstructive Sleep Apnea

That the level of humidification delivered to patients during CPAP treatment will alter the subjects mucociliary clearance rate and related mucus properties.


Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe obstructive sleep apnea - Apnea Hypopnea Index (AHI) \> 15
* 75% of events during the diagnostic study must be obstructive

Exclusion Criteria:

* Currently using CPAP treatment OR have used it in the past 4 weeks
* Intolerance of CPAP and/or CPAP mask in the past or during the titration night
* Mouth breather (unable to breath through mouth for the study period)
* \< 18years old
* Nasal CPAP intolerance determined in the PSG-CPAP titration study
* Serious nasal issues
* Acute upper airway disease
* Smoker
* COPD
* Congestive heart failure
* Neuromuscular disease
* Stroke
Employment-based Reinforcement to Motivate Drug Abstinence in the Treatment of Drug Addiction. - 2

The purpose of this study is to determine whether long-term exposure to the Therapeutic Workplace intervention could sustain drug abstinence over an extended period of time in heroin- and cocaine-dependent, unemployed, treatment-resistant young mothers.

The current study is a continuation of the research into the development and evaluation of a novel treatment designed to address the chronic, persistent nature of drug addiction. This treatment, called the Therapeutic Workplace, integrates abstinence reinforcement contingencies of proven efficacy into a model supported work program. Participants were paid to work or to train in the Therapeutic Workplace but had to provide drug-free urine samples to gain daily access. Forty participants were randomly assigned to a Therapeutic Workplace or usual care control group. Therapeutic Workplace participants could work for about 5 years. This study reports the effects of the intervention over a follow-up period of 8 years after treatment initiation.

Eligibility Criteria:
Inclusion Criteria:

* When originally enrolled in the study, participants were at least 18 years old, unemployed, and methadone maintenance patients of the Center for Addiction and Pregnancy (CAP) who continued to use opiates or cocaine during CAP treatment.

Exclusion Criteria:

* Participants were excluded if they were at risk for suicide at the time of intake or if they had serious psychiatric illness (e.g., schizophrenia).
Health Economic Assessment of Lower Extremity Diabetic (HEALED) Ulcers With PriMatrix

The objective of this study is to compare the effectiveness of PriMatrix Moist Wound Therapy (MWT) with Standard of Care MWT for the treatment of chronic diabetic foot ulcers in subjects with diabetes mellitus and without significantly compromised arterial circulation.

This study will be a multi-center, prospective, randomized single-blinded study evaluating the efficacy of PriMatrix MWT versus Standard of Care MWT in achieving complete wound closure of chronic diabetic foot ulcers by 12 weeks (84 days). To measure wound recidivism and changes in functional quality of life, each subject will complete the Cardiff Wound Impact Schedule and the SF-36v2™ at three time points during the study i) at initial screening, ii) at completion of treatment phase, and iii)at 24 weeks (post-randomization). Additionally, the data obtained from the SF-36v2™ will be used in an economic evaluation of the treatment arms.

Eligibility Criteria:
Inclusion Criteria:

* Type I or Type II diabetes
* A diabetic foot ulcer located on the foot or ankle at least one square centimeter

Exclusion Criteria:

* Suspected or confirmed signs/symptoms of wound infection
* Hypersensitivity to bovine collagen
Success Rate of Immediately Loaded Implants With Platform Switched Design Placed in Anterior Part of Mandible and Restored With Fixed Prostheses

Change in crestal bone level implants at 5% significance level.


Eligibility Criteria:
Inclusion Criteria:

* age 18 to 80
* male or female (female non-pregnant)
* sufficient oral hygiene
* no inflammation/disorder in the area of implant site
* edentulous mandible and sufficient prosthetic and conservative
* sufficient width and height of bone to place implants with diameters of 4.8mm and length of 11 mm
* provide written informed consent

Exclusion Criteria:

* demonstrate a need for pre-surgical bone or soft tissue augmentation in planned implant areas
* exhibit angulation requirements of restoration exceeding 15 degrees
* systemic metabolic disorder that would compromise post-operative tissue regeneration or osseointegration
* taking medication that would compromise post-operative healing and/or osseointegration
* bone disorders such as osteoporosis, hyperparathyroidism, Paget's disease, diabetes mellitus
* oncology treatment
* oral infection
* acute gingivitis and/or periodontitis
* local bone defects in the area of planned implantation
* disorders of oral mucosa (e.g., leukoplakia, oral lichen, pemphigoid lesions)
* received investigational drug within 30 days
* history of illicit drugs or alcohol abuse
* history of addiction to medication
* allergic to dental materials
* nicotine abuse (\> 20 cigarettes/day)
* pregnant or nursing
* clinical significant or unstable medical or physiological conditions that would compromise participation in study
* unable or unwilling to return for follow-up visits for a period of 24 months
EMOTION & COGNITION in MYOCLONUS DYSTONIA (AGENT10-ECODYST)

Background:

Myoclonus dystonia (DYT-SGCE) is characterized by myoclonus and dystonia. Such condition is associated with a high prevalence of psychiatric symptoms which are part of the phenotype. The mechanisms underlying these non-motor symptoms are still poorly understood.

Objective:

To investigate the neural correlates of cognition and emotion in DYT-SGCE.

Design:

Participants will have 1 - 2 visits at the clinical center. The total participation time is less than 24 hours.

Participants will have a medical interview and a neurological exam. They may give a urine sample before MRI.

Participants will have a short neuropsychologic and psychiatric interviews. Participants will have MRI scans. They will do small tasks or be asked to imagine things during the scanning.

Eligibility:

DYT-SGCE patients and healthy volunteers (HV) between 15 and 60 years old.

Eligibility Criteria:
Inclusion Criteria:

For all participants:

* Age between 15-60 years
* Able to give informed consent.

For patients:

* An established diagnostic of DYT-SGCE
* No change in medication (related to DYT-SGCE) for a month

For controls:

* No neurological symptoms
* No medication except oral contraception

Exclusion Criteria:

* No deprivation of liberty
* Inability to give a consent
* Established cognitive alteration
* Contraindication to MRI (per MRI safety checklist)
* Severe chronic psychiatric illness
Psychomotor Therapy Effects in Adaptive Behavior and Motor Proficiency in Intellectual Disability

People with intellectual and developmental disabilities (IDD) usually present limitations at adaptive behavior and motor skills, which lead to limitations/barriers in the daily independent functioning of this population. The main goal of this research is to analyze the efficacy of a Psychomotor Intervention Program on adults with and without IDD, through an assessment of their progress both in adaptive behavior competences and motor proficiency skills.

This study sample comprised 15 participants divided by three groups of 5 individuals each: one group with IDD (with different ethiology), another one with Down Syndrome and the third with typical development. Ages range from 22 to 31 years-old (Average=26,5; St. Deviation=3,76), 6 were females and 9 males. All adults with IDD were all institutionalized at an Occupation Activities Centre of an institution and adults without ID were selected by convenience, with ages comprised within the selected range. All groups were compared through both evaluation instruments: the Portuguese version of Adaptive Behavior Scale (PABS) and Bruininks-Oseretsky Motor Proficiency Test (BOT-2). Both tests were applied according to original protocols. Ethics requisites were fulfilled. After the initial assessment, a Psychomotor Intervention Program was designed specifically for participants with IDD. This program integrated individual and group sessions during 3 months, and the main goals of the program were related to motor coordination (balance, manual dexterity and coordination, global and fine praxis), economic and professional activities, academic and verbal skills.

Eligibility Criteria:
Inclusion Criteria:

* ages above 18 years
* diagnosis of intellectual disability
* institution in Castelo Branco

Exclusion Criteria:

* other co-morbilities associated
* not institutionalised
AI-aided Optical Coherence Tomography for the Detection of Basal Cell Carcinoma

Basal cell carcinoma (BCC) is the most common form of cancer among the Caucasian population. A BCC diagnosis is commonly establish by means of an invasive punch biopsy (golden standard). Optical coherence tomography (OCT) is a safe non-invasive diagnostic modality which may replace biopsy if an OCT assessor is able to establish a high confidence BCC diagnosis. Hence, for clinical implementation of OCT, diagnostic certainty should be as high as possible. Artificial intelligence in the form of a clinical decision support system (CDSS) may improve the diagnostic certainty of newly trained OCT assessors by highlighting suspicious areas on OCT scans and by providing diagnostic suggestions (classification). This study will evaluate the effect of a CDSS on the diagnostic certainty and accuracy of OCT assessors.

In this diagnostic case control design, OCT assessors will retrospectively evaluate OCT scans of equivocal BCC lesions twice (once with, and once without the help of the CDSS). A total of 124 scans (62 BCC/62 non-BCC) will be included in the study. Cases will be shuffled to prevent recall bias. AI-aided OCT scans and unaided OCT scans will be presented in alternating order. The assessors will express their certainty level on a 5-point confidence scale. The diagnostic certainty and diagnostic accuracy of OCT assessment with CDSS and without CDSS will be compared.

Research questions:

1. Does AI-aided OCT assessment result in an increase in high-confidence diagnoses compared to unaided OCT assessment?
2. Does AI-aided OCT assessment result in a significant increase in sensitivity for BCC detection without compromising specificity compared to unaided OCT assessment?
3. Does AI-aided OCT assessment result in more accurate BCC subtyping compared to unaided OCT assessment (explorative)

Eligibility Criteria:
Inclusion Criteria:

* Patients (18+ years)
* Patient underwent OCT scan and punch biopsy for an equivocal BCC lesion

Exclusion Criteria:

- Patient unable to sign informed consent
Noninvasive High Frequency Oscillatory Ventilation as a Post-extubation Respiratory Support in Neonates

A randomized controlled trial comparing Noninvasive high frequency oscillatory ventilation (NHFOV) and Noninvasive positive pressure ventilation (NIPPV) as post-extubation respiratory support in preterm neonates with respiratory distress syndrome(RDS)

The use of noninvasive respiratory support (NRS) has increased in recent decades in Neonatal Intensive Care Unit (NICU) as a means to reduce ventilator-induced lung injury. Various modes of NRS are available and in common use. However despite extensive research, the optimal modality of noninvasive modes remain unknown.

Noninvasive high-frequency oscillatory ventilation (NHFOV) is a relatively new mode. It consists of the application of a continuous distending positive pressure with superimposed oscillations. It is a method of augmenting Continuous positive airway pressure (CPAP) support potentially combining the advantages of both high-frequency oscillatory ventilation and CPAP.

The new NHFOV technique offers improved carbon dioxide (CO2) removal and increased functional residual capacity. The superimposed oscillations of NHFOV are thought to help avoid gas trapping and upregulate mean airway pressure.

This technique is also characterized by lower tidal volume resulting in fewer barotraumas /volutraumas and not needing synchronization. NHFOV was considered a strengthened version of CPAP.

The hypothesis is that NHFOV might be superior to NIPPV as a post-extubation respiratory support strategy to avoid reintubation and subsequent complications and/or sequelae in preterm infants.

Eligibility Criteria:
Inclusion Criteria:

1. Preterm neonates with gestational age ≤ 35 weeks.
2. Neonates that were on invasive mechanical ventilation for at least 48 hours eligible for extubation

Exclusion Criteria:

1. Patients with major upper or lower airway anomalies.
2. Patients with significant congenital anomalies including cardiac, abdominal or respiratory.
Perioperative Chemotherapy With Bevacizumab for Colorectal Carcinomatosis

The Bev-IP trial is designed to assess the feasibility and efficacy of a combined treatment consisting of perioperative combination chemotherapy with the vascular endothelial growth factor A inhibitor bevacizumab and cytoreductive surgery with intraperitoneal oxaliplatin.


Eligibility Criteria:
Inclusion Criteria:

* biopsy proven adenocarcinoma of the colon or rectum and synchronous or metachronous peritoneal carcinomatosis.
* absence of systemic disease, with the exception of small, superficial liver metastases, requiring only minor surgery.
* resectable disease at staging, during laparoscopic evaluation and during exploration for cytoreductive surgery and intraperitoneal chemotherapy.
* complete macroscopic cytoreduction at the time of surgery (CC-0/1)
* good general health status (Karnofsky index \> 70%)
* expected life expectancy more than 6 months
* no other malignancy than disease under study
* serum creatinine \< 1.5 mg/dl or a calculated GFR ≥ 60 mL/min/1.73 m
* serum total bilirubin \< 1.5 mg/dl
* platelet count \> 100,000/ml
* hemoglobin \> 9g/dl
* neutrophil granulocytes \> 1,500/ml
* International Normalized Ration (INR) 2 or \< 2
* Absence of alcohol and/or drug abuse
* No inclusion in other clinical trials interfering with the study protocol
* No concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not indicated in the study protocol
* Absence of heart failure (NYHA 2 or \> 2) or significant coronary artery disease
* No pregnancy or breast feeding
* Adequate contraception in fertile patients

Exclusion Criteria:

* No written informed consent
* tumour in the presence of obstruction
* evidence of extra-abdominal disease or extensive liver metastasis
* peritoneal cancer index \> 25
* active bacterial, viral or fungal infection
* active gastro-duodenal ulcer
* parenchymal liver disease (any stage cirrhosis)
* uncontrolled diabetes mellitus
* severe obstructive or restrictive respiratory insufficiency
* psychiatric pathology capable of affecting comprehension and judgment faculty
* Known allergy to oxaliplatin
REVAXIS® Versus DT Polio® as a Second Booster in 6 Year-old Children

Primary objective:

To demonstrate the non inferiority between REVAXIS® and DT Polio® when given as a second booster to healthy 6 year-old children .

Secondary objectives:

* Additional immunogenicity assessments.
* To describe the safety profile of a single dose of REVAXIS® or DT-Polio®


Eligibility Criteria:
Inclusion Criteria:

1. Healthy child without chronic severe disease of either gender,
2. 6 year-old child on vaccination day,
3. Child previously vaccinated with three doses of a diphtheria, tetanus and poliomyelitis containing vaccine given alone or in combination within the first 6 months of life and a booster dose of a diphtheria, tetanus and poliomyelitis containing vaccine given alone or in combination at 16 - 18 months of life (±2 months),
4. Consent form signed by both parents, or by the legal representative, properly informed about the study.

Exclusion Criteria:

1. Child who had received less or more than 4 doses of a diphtheria, tetanus and/or poliomyelitis containing vaccine,
2. Previous clinical or bacteriological diagnosis of diphtheria, tetanus or poliomyelitis,
3. Child who had received any vaccine in the previous 30 days or with a vaccination scheduled during the course of the study,
4. Child who present with immune impairment or humoral/cellular deficiency, neoplastic disease or depressed immunity,
5. Child who had received within the previous 150 days or who will receive during the course of the study, any immunoglobulins or blood derived products,
6. Child with true hypersensitivity to at least one of the components of a study vaccine or to streptomycin, neomycin or polymixin B,
7. Known personal history of encephalopathy, seizure disorder or progressive, evolving or unstable neurological condition,
8. Child who had presented severe hypersensitivity following an earlier immunization against diphtheria and/or tetanus,
9. Known history of thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection,
10. Acute severe febrile illness and/or oral temperature ≥37.5°C at the time of vaccination
Myo-inositol Versus D-chiro-inositol in the Treatment of Polycystic Ovary Syndrome and Insulin Resistance: Evaluation of Clinical, Metabolic, Endocrine and Ultrasound Parameters

Insulin resistance has important implications in the pathogenesis of the polycystic ovary syndrome (PCOS) and insulin-sensitizing drugs are considered a useful therapeutic approach.

Reduction of insulin levels with administration of insulin sensitizing agents has been found to be beneficial in lowering both hyperinsulinemia, hyperandrogenemia, and restoring ovulation. Metformin alone or in combination with oral contraceptives (OCs) has been widely used in the long term treatment of women with PCOS in whom it modifies the ovarian morphology, improves intraovarian androgen levels, and enhances systemic and local insulin resistance. Despite to these beneficial effects, several side effects have been reported due to the long term administration of this drug.

In the recent years, inositol has found more and more space in the reproductive clinical practice. Indeed, inositol have been classified as "insulin sensitizing agent" and it is mainly used as a chronic treatment for PCOS. Inositol exists in 9 different isomers and in particular several studies on Myo-inositol and D-chiro-inositol were reported.

In this study myo-inositol versus D-chiro-inositol treatments were compared to placebo in women with PCOS and with or without insulin resistance.


Eligibility Criteria:
Inclusion Criteria:

* Women fulfilled two out of three diagnostic criteria for PCOS

Exclusion Criteria:

* Women with pre-existing secondary endocrine disorders
* Women with personal history of hypertension, diabetes mellitus or cardiovascular disorders
* Women who received treatment with other drugs for the previous 6 months before entering the study.