cyrilzakka/clinical-trials huggingface dataset:
CDC-ATN Linkage Evaluation

The goal of ATN 093 is to determine program-level factors associated with the effectiveness of SMILE in Caring for Youth Linkage-to-Care (LTC) program network at the 15 Adolescent Medicine Trial Units (AMTU). This will be accomplished by evaluating and categorizing the various LTC programs at the AMTUs and then examining the association between the LTC program characteristics (providers, practices, and systems) and the proportion of Human Immunodeficiency Virus (HIV)-infected youth, ages 12-24 years old, inclusive, linked to care and maintained in care. As such, this study focuses on LTC programs at the AMTUs as the unit of analysis and not the youth themselves.


Eligibility Criteria:
Inclusion Criteria:

* Each enrolling site must have the capability to input field data that can be used to evaluate the effectiveness of the Strategic Multisite Initiative for the Identification, Linkage, and Engagement in Care of Youth with Undiagnosed HIV Infection (SMILE in CARING for YOUTH) Project
Efficacy and Safety of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis

The two objectives of this study were to evaluate long-term efficacy and safety of adalimumab treatment in participants who had moderate to severe chronic plaque psoriasis and to evaluate the effectiveness of adalimumab retreatment in participants who had therapeutic response to adalimumab and were then withdrawn from adalimumab treatment.

Study M03-658 was a continuation study for participants with moderate to severe psoriasis who had participated in a prior psoriasis adalimumab study. Study M03-658 consisted of three sequential treatment periods. The first period was Period O, in which participants received open-label treatment with adalimumab (40 mg every other week or 40 mg every week) for a minimum of 104 weeks and a maximum of 252 weeks. Period O was the only period of the study until May 2008, when the subsequent periods were added via amendment to the protocol. At that time, participants who had achieved satisfactory therapeutic response (a Physician's Global Assessment \[PGA\] of 0, 1, or 2 \[clear, minimal, or mild\]) were given the opportunity to discontinue from the study or to continue and participate in the subsequent two periods. The second period was Period W, a maximum of 52 weeks, in which participants with a PGA of 2 (mild) or less were withdrawn from adalimumab treatment (i.e., participants received no treatment) until relapse of their psoriasis occurred (defined as a PGA of 3 \[moderate\] or worse). The third period was Period R, a 16-week period in which participants were retreated with open-label adalimumab (80 mg initial dose followed by 40 mg every other week). Period O was designed to evaluate the first objective regarding long-term efficacy and safety of adalimumab treatment, and Period R was designed to evaluate the effectiveness of adalimumab retreatment following relapse. Specific subsets of the study population that were identified as the populations of interest were the modified intent-to-treat populations for Period W and Period R, and these are described further in the outcome measures.

Eligibility Criteria:
Inclusion Criteria:

* Subject was age 18 or older and in good health (Investigator discretion) with a recent stable medical history.
* Subjects who met the requirements from previous adalimumab psoriasis study participation.

Exclusion Criteria:

* Subject considered by the Investigator, for any reason, to be an unsuitable candidate for the study.
* Female subject who was pregnant or breast-feeding or considering becoming pregnant.
Magnetic Resonance Imaging Study of Geriatric Depression

The purpose of this study was to use Magnetic Resonance Images to further our understanding of predictors and markers of treatment response and non-response in geriatric depression. We hypothesized that concentrations of high energy metabolites would be lower in depressed elderly compared to non-depressed.


Eligibility Criteria:
Inclusion Criteria:

* DSM- IV (Diagnostic and Statistical Manual of Mental Disorders, 4th Edition) diagnostic criteria for major depressive disorder
* Hamilton Depression Scale- 17 item version score of 18 or higher
* Must speak English
* Women must be post-menopausal

Exclusion Criteria:

* A current or pervious psychiatric disorder other than MDD
* A current unstable medical condition
* A pacemaker or metal implant
* History of alcohol or drug dependence or abuse within the past year
* Current prescription of excluded medications
* Use of a drug within the last 30 days that was not approved for use by governmental authorities.
* If you or a family member works at McLean Hospital
Electrophysiological Findings in Fibromyalgia Patients

Fibromyalgia Syndrome (FMS); It is a chronic condition characterized by widespread body pain, sleep disturbance, fatigue, impaired cognitive functions, and anxiety (1). FMS; chronic fatigue syndrome, interstitial cystitis, irritable bowel syndrome, temperomandibular joint dysfunction, myofascial pain, functional dyspepsia, restless leg syndrome and posttraumatic stress disorder are among central sensitization syndromes (2,3).

Etiology and pathogenesis in fibromyalgia have not been fully elucidated. Many mechanisms contribute to the formation of FMS. Many evidence has been found for dysfunction of the central and autonomic nervous system, immune system, cytokines, neurotransmitters and hormones, which are thought to play a role in the disease.

Since increasing systemic inflammation is thought to have a role in the etiopathogenesis of FMS, there are increasing numbers of studies focusing on this aspect of fibromyalgia.

Neutrophil / lymphocyte ratio (NLR) and platelet / lymphocyte ratio (PLR) in peripheral blood are simple markers of systemic inflammatory response.

Another factor thought to have a role in etiopathogenesis is autonomic nervous system dysfunction. It has been found that there is autonomic dysfunction in the sympathetic nervous system in patients with FMS. Sympathetic skin response measurements are frequently used electrophysiological methods to evaluate the functionality of the sympathetic nervous system, which is a component of the autonomic nervous system.

In addition, vitamin D deficiency is common in FMS patients. In a study, inadequate vitamin D levels were found in 45% of fibromyalgia patients.

When a literature review is performed, it is seen that electrophysiological studies are performed to evaluate autonomic dysfunction in patients with fibromyalgia. No studies were found showing the relationship between vitamin D levels and inflammatory parameters in patients with fibromyalgia and electrophysiological findings. In our study, it was aimed to compare the autonomic dysfunction of fibromyalgia patients with healthy volunteers by electrophysiological evaluation and to investigate the relationship between vitamin D levels and inflammatory parameters in fibromyalgia patients and the data obtained from electrophysiological studies. In this way, we aimed to contribute to a better understanding of the physiopathology of fibromyalgia patients with autonomic dysfunction.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old To be diagnosed with FMS according to the criteria of American College of Rheumatology (ACR) 2010 Confirmed diagnosis of FMS according to American College of Rheumatology (ACR) 2016 criteria

Exclusion Criteria:

* Presence of acute infection Diabetes Mellitus B12 deficiency Hypothyroidism Inflammatory-rheumatological disease presence A history of malignancy Major psychiatric disorder Dementia, etc. diseases that may cause loss of cognitive functions
Recovery of Bladder and Sexual Function After Spinal Cord Injury

Bladder and sexual dysfunction consistently ranks as one of the top disorders affecting quality of life after spinal cord injury. The insights of how activity-based training affects bladder function may prove to be useful to other patient populations with bladder and sexual dysfunction such as multiple sclerosis, Parkinson's, and stroke, as well as stimulate investigations of training's effects within other systems such as bowel dysfunction. Locomotor training could help promote functional recovery and any insights gained from these studies will enhance further investigation of the effect of bladder functioning after spinal cord injury. In addition, as suggested by a study of one of our initial participants, a reduction in the use and/or dosage of medication to enhance sexual function is a possible outcome, medications which carry risks and side effects.

Objectives: To determine the effects of weight-bearing task-specific training for locomotion (stepping on a treadmill) after traumatic incomplete and complete spinal cord injury in humans on a) urodynamic parameters and b) sexual function outcomes. Weight-bearing (stand-only) and non-weight-bearing exercise (i.e. arm crank) will serve as controls.

Eligibility Criteria:
Criteria: Inclusion Criteria:

* stable medical condition without cardiopulmonary disease or dysautonomia that would contraindicate locomotor training, stand, or non-weight bearing training
* no painful musculoskeletal dysfunction,
* unhealed fracture, contracture, pressure sore or urinary tract infection that might interfere with training
* no clinically significant depression or ongoing drug abuse;
* clear indications that the period of spinal shock is concluded determined by presence of muscle tone, deep tendon reflexes or muscle spasms and discharged from standard inpatient rehabilitation
* non- progressive suprasacral spinal cord injury
* bladder and sexual dysfunction as a result of spinal cord injury

Exclusion criteria:

* unstable medical condition with cardiopulmonary disease or dysautonomia that would contraindicate locomotor training, stand, or non-weight bearing training;
* painful musculoskeletal dysfunction, unhealed fractures, contractures, pressure sores or urinary tract infections that might interfere with training
* clinically significant depression or ongoing drug abuse;
* clear indications that the period of spinal shock has not concluded and not discharged from standard inpatient rehabilitation
* progressive spinal cord injury
* no bladder and sexual dysfunction as a result of spinal cord injury
Evaluation of the Performance of the CleanC System-Israel

The Motus GI Colon Cleansing device is intended to facilitate intra-procedural cleaning of a poorly prepared colon by irrigating the colon and evacuating the irrigation fluid and feces.

The study aim to evaluate the post Procedure Cleansing Level as Measured by the Boston Bowel Preparation Scale (BBPS).

Each subject was required to follow a bowel preparation regimen including split dose of 2 tablets of 5mg Bysacodyle followed by a colonoscopy procedure with the tested device.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects in the age range of 18-75 years
2. Subjects with BMI within the range of 18.5-35
3. Subject is willing to sign informed consent form

Exclusion Criteria:

1. Active or severe inflammatory bowel disease (IBD)
2. Subjects with severe diverticulitis \\ diverticular disease (known or detected)
3. Known or detected colonic stenosis
4. Known or detected bowel obstruction
5. History of prior colon surgery
6. ASA≥IV (sever systemic disease)
7. Sever Renal insufficiency (Creatinine≥1.5mg%)
8. Sever Liver insufficiency (ALT/AST≥2UNL)
9. Contraindication for "colonoscopy" anesthesia \\ sedation \\ prep agent
10. pregnancy
11. Subjects with altered mental status/inability to provide informed consent
12. Subject has a condition or is in a situation which in the investigators opinion may put the subject at significant risk, may confound the study results, or may interfere significantly
Endoscopic Treatment for Local Residual Neoplasia

Endoscopic mucosal resection (EMR) is considered to be a gold standard of therapy of colorectal lateral spreading tumors (LST) without significant risk for lymphatic spread. According to the investigators previous study, local residual neoplasia (LRN) after conventional endoscopic mucosal resection (EMR)occurs in up to 21% of cases. Endoscopic therapy of LRN was not sufficient in 53 % and has not been standardized yet.


Eligibility Criteria:
Inclusion Criteria:

* patients older than 18 years
* patients with local residual neoplasia in scar in three months after endoscopic mucosal resection for laterally spreading tumor (0-IIa \> 10 mm)
* signed informed consent

Exclusion Criteria:

* incomplete endoscopic mucosal resection
* previous therapy for local residual neoplasia
* difficult or impossible localization of post-EMR scar
Serum Endocan Levels and Gestational Diabetes

In diabetic patients, serum endocan level has been significantly increased in patients and the levels on the long-term complications are correlated. Based on the Iinformation obtained from these studies, it can be said that there is a strong association between diabetes and serum endocan levels.

It has been shown that endocan level of plasental tissue in gestational diabtes patients is significantly increased when looking at the same week compared with plasenta tissue samples of helathy pregnancy. From the information obtained from these studies, it can be said that there is a strong association between diabetes mellitus and serum endocan levels. investigators aimed to determine the relationship between serum endocan levels and gestational diabetes in the study.

Eligibility Criteria:
Inclusion Criteria:

* being pregnant at 24-26 weeks of gestation
* having oral glucose toleranse screening test
* age between 18-45 years

Exclusion Criteria:

* having in utero mort fetus
* having a previous diagnosis of diabetes
* having a multiple pregnancy
* having a coronary artery disease
* having preeclampcia
* having a pregnancy obtained by assisted reproductive technology
* using cigarette
* using alcohol
Mangrove-sword Bean-food Bar on the Weight and Weight for Age Z Score of Under-five Children

The goal of this clinical trial is to assess the effect of the food bar made from api-api mangrove (Avicennia marina) and sword bean (Canavalia ensiformis) blends on the weight and Weight-for-Age Z score affected by a landslide disaster.

The main questions aimed to answer are:

* Food bar supplementation can effect the weight and WAZ score of under-five children affected by landslides disaster?
* Balanced nutrition education can increase the mothers' knowledge on the balanced nutrition of under-five children?

Participants divided in to two group i.e.:

* Treatment/intervention group consumed 50 g mangrove sword bean food bar each day during 15 days.
* Control group consumed 50 g sword bean food bar each day during 15 days.
* Each group received balanced nutrition for mothers once at the first week of study.

Eligibility Criteria for Under-five children:

* Aged between 12 and 59 months
* Male and female
* Living in Cihanjuang Village of Sumedang District which affected by the landslide disaster
* Had malnutrition, normal, or over-nutrition status, and not suffering from infectious diseases.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 12 and 59 months
* Male and female living in Cihanjuang Village of Sumedang District who affected by the landslide disaster
* Had malnutrition, normal, or over-nutrition status
* Not suffering from infectious diseases
* Willing to avoid consumption of any snacks other than the food bars and plain water

Exclusion Criteria:

* Suffered from infectious or chronical diseases
Combined Transcatheter Aortic Valve Implantation and Percutaneous Closure of the Left Atrial Appendage

Atrial fibrillation (AF) is a common comorbidity of patients candidates to transcatheter aortic valve implantation (TAVI). The management of chronic oral anticoagulation (OAC) for the prevention of ischemic stroke is very challenging in this population of complex and frail subjects. Since the percutaneous left atrial appendage (LAA) closure with the WATCHMAN device proved promising safety and efficacy results in randomized comparisons with OAC (current standard of care), the aim of the current study is to assess the feasibility and the early safety of performing TAVI with the Lotus System and percutaneous LAA closure with the WATCHMAN device at the same session.


Eligibility Criteria:
Inclusion Criteria:

* TAVI candidates
* Elderly patients with symptomatic, severe, calcific, native aortic valve stenosis, assessed by echocardiography AVA up to 1.0 cm2 or AVAi up to 0.6 cm2m2 and mean pressure gradient 40 mmHg or jet velocity 4 ms
* Inoperable or at increased surgical risk (according to multidisciplinary heart team decision)
* Non-valvular AF (paroxysmal, persistent or permanent)
* CHA2DS2-VASc ≥ score
* HAS-BLED score ≥ 2
* Written informed consent
* Aortic annulus size ≥ 20 mm and ≤ 27 mm
* Adequate LAA ostium diameter (17 31mm)

Exclusion Criteria:

* Previous TAVI
* Previous LAA closure (surgical or percutaneous)
* Previous RF ablation of AF
* Need for long-term OAC (history of pulmonary embolism, mechanical heart valve)
* Contraindication to aspirin
* Relevant CAD requiring revascularization
* Infective endocarditis
* LV ejection fraction \< 20 percent
* Cardiogenic shock or hemodynamic instability
* Symptomatic carotid disease
* Life expectancy \< 1 year
* Severe renal failure (dialysis or serum creatinine level \> 3.0 mg/dl or 265 μmol/L)
* CVE within the past 3 months
* Acute complications occurring during TAVI procedure
* Congenital unicuspid aortic valve
* Femoral artery lumen diameter \<6.0 mm or \<6.5 mm (for the 23-mm valve or the 25-mm and 27-mm valves, respectively)
* Documented LAA and/or LV thrombi
* Severe MR
* Atrial septal defect
Neuroprotective Effect of Autologous Cord Blood Combined With Therapeutic Hypothermia Following Neonatal Encephalopathy

This study examines the effect of cord blood in the treatment of newborn infants with neonatal encephalopathy in combination with hypothermia, which is the standard treatment for this condition. The hypothesis is that the cord blood + hypothermia combination will produce better neuroprotection than the standard treatment of hypothermia alone.

The primary aim of this study is to determine the neuroprotective effect of intravenous administration of autologous cord blood in neonates with severe encephalopathy (hypoxic ischemic encephalopathy or cerebral infarction). It is hypothesized that the administration of autologous cord blood will be safe and well tolerated in neonates with severe encephalopathy. If a neonate is born with signs of moderate to severe encephalopathy and cooled for the encephalopathy, the neonate will receive their own cord blood. The cord blood cells are divided into 3 doses and infused at 24, 48, and 72 hours after the birth. Infants will be randomised to treatment with autologous cord blood and hypothermia or hypothermia only and followed for safety and neurodevelopmental outcome up to 18 months. All infants in both groups will be treated with hypothermia for 72 hours started within 6 hours of delivery and infants who allocated to hypothermia and xenon will also receive autologous cord blood in 24 hours from birth through a purpose designed delivery system. Additionally, postnatal neuro-developmental outcomes in neonates with encephalopathy after autologous cord blood therapy will be measured; HIE injury to the neonate/infant brain post autologous cord blood therapy by imaging will be characterized; MRI's will be obtained per clinical routine; serum levels of selected cytokine and neurotrophic factors in neonates with HIE before and after autologous cord blood therapy will be compared and immune cell phenotype and function in neonates with HIE before and after autologous cord blood therapy will be compared.

Eligibility Criteria:
Inclusion Criteria:

1. Gestational age ≥ 34 weeks
2. Birth weight ≥ 1800 grams
3. 10-minute Apgar score ≤5 or continued need for ventilation or severe acidosis, defined as pH \<7.0
4. Moderate to severe encephalopathy (Sarnat II to III)
5. A moderately or severely abnormal background aEEG voltage, or seizures identified by aEEG, if monitored
6. Up to 24 hours of age
7. Autologous umbilical cord blood available to infuse 3 doses within 72 hours after birth
8. Parental informed consent

Exclusion Criteria:

1. Known major congenital anomalies, such as chromosomal anomalies, heart diseases
2. Major intracranial hemorrhage identified by brain ultrasonography or computed tomography
3. Severe intrauterine growth restriction (weight \<1800g)
4. Severe infectious disease, such as sepsis
5. Inability to enroll by 24 hours of age
6. Volume of collected cord blood \<40 ml
7. Infants in extremis for whom no additional intensive therapy will be offered by attending neonatologist
8. Parents refuse consent
Efficacy and Safety of Nitazoxanide for Post Exposure Prophylaxis of COVID-19 in Household Contacts

The primary objective of this study is to evaluate the efficacy of the drug nitazoxanide 500 mg, administered three times a day, in relation to placebo in preventing the development of COVID-19 in household contacts of patients diagnosed with the disease.

Eligible participants (cohabitants of a recently confirmed COVID19 case) residing in Buenos Aires City will be identified by the Ministry of Health and contacted with the investigators, who will visit them at home and offer to participate. For consenting individuals, a rapid serological test and a nasopharyngeal PCR sample for SARS-CoV-2 will be performed and participants will be then randomized to NTZ or placebo to be taken during 7 days.

SARS-CoV-2 PCR will be repeated on day 14th and the serologic rapid test repeated on day 28th.

Clinical status of participants will be assessed daily by phone. Individuals meeting case definition will be evaluated at home and a PCR will be performed. Those with confirmed COVID19 case will discontinue study medication and followed until symptoms resolution.

Eligibility Criteria:
Inclusion Criteria:

* Men and women over 18 and under 65.
* Household contact with a confirmed case of COVID-19 by PCR for Sars-CoV-2.
* Initiate study medication within 4 days from the last close contact with the index case.
* The patient must not present symptoms suggestive of Covid19 (cough, dyspnea, fever\> 37.5 C, fatigue, sore throat, myalgia, diarrhoea) at the time of admission to the study and from previous 14 days.
* Informed consent from the patient or legal representative.

Exclusion Criteria:

* History of infection confirmed by SARS-CoV-2.
* Positive IgG antibodies test for SARS-CoV-2 at the time of admission.
* Have received any dose of nitazoxanide within 7 days prior to screening.
* Known hypersensitivity to any of the study medication components.
* Use of any investigational or unregistered drug or vaccine within 30 days prior to screening, or use planned during the study period.
* Inability to comply with study procedures.
* Current breastfeeding.
* Pregnancy.
* Intolerance or inability to take oral medication.
* History of severe liver disease (Child-Pugh B or C) and/or chronic kidney disease.