cyrilzakka/clinical-trials huggingface dataset:
Colchicine to Quench the Inflammatory Response After Deep Vein Thrombosis (The Conquer-DVT Pilot Trial)

Purpose of the pilot trial:

To assess the feasibility of a full-scale, double-blind, placebo-controlled, randomized trial assessing whether low-dose colchicine (0.5 mg daily) reduces the risk of post-thrombotic syndrome (PTS) in patients with proximal lower extremity deep vein thrombosis (DVT).

Eligible and consenting patients will be randomized via a central web-based randomization system (1:1 ratio) to receive one tablet of colchicine 0.5 mg or identical matching placebo daily starting within 7 days of initiation of anticoagulation for acute, symptomatic, proximal lower extremity Deep Vein Thrombosis (DVT) for a treatment course of 180 days (+/- 7 days). Study drug will start within 24 hours of randomization. The type, dose, and duration of anticoagulant therapy : unfractionated heparin, Low Molecular Weight Heparin (LMWH), fondaparinux, Direct Oral Anticoagulation (DOAC) or Vitamin K Agonist (VKA) will be left to the discretion of the treating physician or local investigator. The study drug will be continued until the end of the treatment period (180 days +/- 7 days). All patients will be observed until the end of study follow-up (365 days +/- 7 days).

Eligibility Criteria:
Inclusion Criteria:

* Consenting patients 18 years of age or older with a first, acute, symptomatic proximal (popliteal vein or more proximal) objectively confirmed DVT of the lower extremity will be eligible to participate in the study.

Exclusion Criteria:

1. History of an allergic reaction or significant sensitivity to colchicine.
2. Requirement of colchicine for other indications.
3. Active or chronic diarrhea, or documented inflammatory bowel disease (i.e., Crohn's disease or ulcerative colitis), collagenous colitis or irritable bowel syndrome or existing blood dyscrasias.
4. Known or suspected, recent (\<30 days) or active infections (acute or chronic).
5. History of cirrhosis, chronic active hepatitis, or severe liver disease.
6. Recent (\<30 days) or chronic use of systemic (oral, intravenous) immunosuppressive drugs (including but not limited to steroids, tumor necrosis factor-alpha blockers, cyclosporine).
7. Known active cancer.
8. Any of the following as measured within the past 1-3 months or at screening: alanine, or aspartate aminotransferase \>3 times the upper limit of normal, total bilirubin \>2 times the upper limit of normal and a creatinine clearance by Cockcroft-Gault formula \<30 mL/min.
9. Pregnancy, breast feeding or may be considering pregnancy during the study period or women of childbearing potential unwilling to use appropriate contraception during sex;
10. The use of medication with known drug-to-drug interactions (including but not limited to erythromycin or clarithromycin).
11. Unable or unwilling to provide consent.
Effect of Sinufoam-Dexamethasone Mixture on Post Endoscopic Sinus Surgery Outcomes

Dexamethasone added to sinufoam, which is placed in the ethmoid cavity at the completion of endoscopic sinus surgery, will improve sinonasal mucosal healing.

Sinufoam is an FDA approved mixture, which is placed in the ethmoid cavity at the completion of an endoscopic sinus surgery procedure. Sinufoam prevents scarring and promotes healing of the sinonasal mucosa. Sinufoam is commonly mixed with saline, which enables it to be liquefied and gently placed into the ethmoid cavity. Recent practice of adding Dexamethasone to the sinufoam mixture has been hypothesized to promote healing by reducing chronic inflammation associated with CRS. Using topical dexamethasone mixed into the Sinufoam solution may improve patient care by preventing the systemic effects associated with post-operative systemic steroid use.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years old
* Chronic Rhinosinusitis without nasal polyps --- defined according to the AAO guidelines
* Elective "Bilateral" sinus surgery requiring at a minimum of an Uncinectomy, Maxillary Antrostomy, and Anterior Ethmoidectomy.

Exclusion Criteria:

* Uncorrectable coagulopathy
* Emergency procedure
* Unavailable for standard post operative follow-up
* Sinonasal neoplasm resections
* Excessive intra-operative bleeding requiring nasal packing
Laparoscopic Exploration Versus Abdominal CT Scan

Evaluate the efficacy and safety of laparoscopy and it's role with blunt abdominal trauma

Evaluate the role of laparoscopy and Abdominal Ct scan in diagnosis and treatment of abdominal trauma and which is more effective and safe laparoscopy or CT

Eligibility Criteria:
Inclusion Criteria:

* stable patients with definite occurrence of intra-abdominal injury
* patients with equivocal result by clinical and radiological evaluation

Exclusion Criteria:

* patients with penetrating abdominal trauma
* stable patients not in need for any intervention for conservative management
* patients with marked haemodynamic instability
* polyt-traumatized Patients
Nasolabial Soft Tissue Esthetics and Maxillary Changes in Unilateral Cleft Lip and Palate Using PreSurgical Infant Orthopedics With Different Approaches

The nasal deformity is an abnormality in the appearance and structure of the nose in cleft patients having unilateral cleft lip and palate (UCLP). It involves the displacement of the lower lateral nasal cartilage, oblique and short columella, depressed dome, overhanging nostril apex, and deviated septum. Difficulty in breathing and smelling are the main problems of this deformity. Rhinoplasty for CLP patients is very complicated due to the complex nature of this type of deformity, especially in wide and bilateral cleft patients it is quite challenging.

The nasal deformity is an abnormality in the appearance and structure of the nose in cleft patients having unilateral cleft lip and palate (UCLP). It involves the displacement of the lower lateral nasal cartilage, oblique and short columella, depressed dome, overhanging nostril apex, and deviated septum. Difficulty in breathing and smelling are the main problems of this deformity. Rhinoplasty for CLP patients is very complicated due to the complex nature of this type of deformity, especially in wide and bilateral cleft patients it is quite challenging. The cleft width along with the nasal deformity and collapse in the nasal cartilage could affect the outcome of the surgical lip closure with the cleft width as a major factor affecting the tension produced in the closure and future collapse of the nose. There is a striking diversity in the literature regarding treatment protocols for UCLP, with no standardized management protocols . Clinical decision-making based on evidence is lacking due to the few randomized clinical trials comparing the effectiveness of different approaches. A recent systematic review conducted a comprehensive search aiming at identifying the different treatment protocols and effectiveness of using pre-surgical infant orthopedics (PSIO) and recommended the need for further well-designed and high-quality randomized clinical trials (RCTs) in this area due to the unstandardized protocols with high diversity. Various studies supported the positive effect of naso-alveolar molding (NAM) appliance therapy on nasal symmetry in UCLP treatment. The NAM therapy decreases the severity of the initial cleft deformity and repositions deformed nasal cartilage and alveolar process, which has many beneficial results in the surgery outcome. Taping has been assessed in infants with UCLP and was deemed successful as well by a few studies. To our knowledge, no RCTs are comparing the use of NAM therapy to taping with the use of nasal elevators on UCLP patients.

Eligibility Criteria:
Inclusion Criteria:

* Infants with 0 (after birth) to 1 month of age
* Non-syndromic with no other medical conditions
* Unilateral complete cleft lip and palate
* Cleft width \> 5 mm

Exclusion Criteria:

* Syndromic UCLP or bilateral cleft lip and palate
* Incomplete UCLP
* Cleft width ≤ 5 mm
The Effect of Binaural Sound on the Occurrence of Emergence Delirium in Children Undergoing Strabismus Surgery

The hypothesis of this study is that providing continuous binaural beats with a phase difference in alpha frequency during anesthesia can reduce the incidence of emergence agitation in pediatric patients. To test this hypothesis, the occurrence of emergence agitation will be compared between the group that received binaural beats and the group that did not receive binaural beats.


Eligibility Criteria:
Inclusion Criteria:

* Children under the age of 7 receiving a strabismus surgery under general anesthesia.
* American Society of Anesthesiologists Physical status classification 1-2.

Exclusion Criteria:

* Pediatric patients with hearing impairment or those who are currently using a hearing aid
* Pediatric patients with neurological disorders
* Pediatric patients with respiratory disorders
Evaluation of Home-based Sensor System to Detect Health Decompensation in Elderly Patients With History of CHF or COPD

Sensorum Health (Sensorum) is conducting a pilot study to determine if Sensorum's proprietary passive sensor network can be used to identify signals of early health decompensation in subjects prior to a hospitalization for chronic disease exacerbation or other ambulatory care sensitive conditions. Successful early detection would provide a window of opportunity to intervene outside of the acute setting in future interventional studies.


Eligibility Criteria:
Inclusion Criteria:

* Aged 65 years or older
* Able to consent
* Documented history of diagnosis of chronic obstructive pulmonary disease (COPD) and/or congestive heart failure (CHF)
* Currently admitted to JSUMC for observation or as an inpatient with any diagnosis ≥1 prior hospital utilization events with any diagnosis (inpatient admissions, facility observation stays, or ED visits) in the past 12 months

Exclusion Criteria:

* Significant cardiac valvular disease
* End-Stage Renal Disease (ESRD)
* End-Stage CHF
* End-Stage COPD
Effect of Salsalate on Bed Rest-Induced Vascular Dysfunction

Physical inactivity induces vascular dysfunction and glucose intolerance during five days of bed rest. This study will investigate the effects of salsalate on these responses. Subjects will be randomized to treatment with salsalate or placebo for four days prior to initiation of bed rest. Vascular function in the brachial artery will be determined by ultrasound prior to treatment and before and after the 5-day bed rest protocol. We hypothesize that treatment with salsalate will be associated with protection again the development of glucose intolerance and vascular dysfunction in this setting.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

* Pregnancy
* History of Coronary Artery Disease
* Diabetes Mellitus
* Hypertension
* Cigarette smoking
* History or family history of deep vein thrombosis or pulmonary embolism
* Abnormal renal function
* Liver function tests greater than two times the upper limit of normal
* Anemia
* Use of viagra or other PDE5 inhibitor
* Hypercholesterolemia
* Aspirin allergy/sensitivity
* Asthma with nasal polyps
* Peptic ulcer disease/Gastrointestinal bleeding
* Any ongoing drug treatment
Diet, Genes and Colorectal Cancer - With Focus on Toll-like Receptor Polymorphisms

The aim of this study is to investigate the interaction between diet - primary meat and fiber - and polymorphisms in Toll-like receptors in relation to risk of colorectal cancer in a Danish prospective cohort.

Meat and dietary fibers have been associated with increased and decreased risk of colorectal cancer (CRC), respectively. Toll-like receptors (TLRs) regulate intestinal immune response in a complex interplay between the mucosal epithelium and the microbiota and may therefore be important modulators of diet-induced CRC and interact with other inflammatory mediators.

The aim of the study is to investigate the association with functional TLR polymorphisms in relation to risk of CRC and their interaction with dietary factors. Additionally, interactions with previously studied polymorphisms in IL10, IL1B, PTGS2 and NFKB1 will be assessed in order to examine possible biological pathways in meat-induced CRC.

Data are retrieved from the Danish prospective "Diet, Cancer and Health" study encompassing 57,053 persons which were recruited between 1993 to 1997. Between 1994 and 31th December 2009, 1038 CRC cases has been diagnosed. A sub-cohort of 1857 persons has been randomly selected within the full cohort at time of entry into the cohort. The study design is a nested case-cohort study.

Eligibility Criteria:
Inclusion Criteria:

* Born in Denmark and had no previous cancers at study entry

Exclusion Criteria:

* Previous or present cancer(s) at study entry
Medical College Students' Responds to Menu Labeling

The purpose of this study is to evaluate whether exposure to nutrition information with or without nutrition education would influence college students' dietary choices and improved the previous photographs-based dietary assessment tools.

1. The investigators improved the previous photographs-based dietary assessment tools and utilized the improved approach to evaluate participants' calorie and nutrients intake.
2. A pre-post non-controlled study design was implemented in the medical college and was divided into three stages: just recording the dietary selection in the three meals daily, recording the dietary selection with the provision of menu labeling accompanying with or without nutrition education. The investigators adopted photographs-based dietary assessment tools and a mobile phone application 'WeChat' was utilized as the photographs and nutrition knowledge transfer platform. Two professional researchers respectively read the received photographs and calculated participants' calorie and nutrients intake.

Eligibility Criteria:
Inclusion Criteria:

* Grade 2012, 2013 undergraduate students and Grade 2013 graduate students

Exclusion Criteria:

* Participants who sent the photographs less than six times in any one of the three meals at any stage

  * Participants who did not complete their questionnaires

    * Participants who withdrew from the experiment at any stage
Continuous Glucose Monitoring Profile Description Under Alpelisib treAtment in Patients With Advanced bREast Cancer

The purpose of this study is to describe the glycemic profile of postmenopausal women treated with alpelisib plus fulvestrant using a continuous blood sugar monitoring device (FreeStyle Libre Pro) over 14 days

AAREN is a monocentric prospective study monitoring glycemic profile in patients treated with alpelisib plus fulvestrant. Patients will wear a noninvasive glucose monitoring sensor, the Freestyle Libre Pro for a 14 day period. Forty patients will be enrolled.

Eligibility Criteria:
Inclusion Criteria:

1. Women suffering breast cancer and eligible to treatment with Alpelisib
2. Age ≥18 years
3. Menopausal women (for at least 24 months)
4. Informed Consent Form signed

Exclusion Criteria:

1. Men
2. Pregnant ou child-bearing potential women
The Pharmacokinetics of Zidovudine and Oxazepam Alone and in Combination in the HIV-Infected Patient

To determine if a pharmacokinetic (blood level) interaction exists between zidovudine (AZT) and oxazepam in the HIV-infected patient. Benzodiazepines (such as oxazepam) are among the most frequently prescribed class of drugs and are commonly used therapeutically for patients with chronic disease. This study is important because of the potential for toxicity resulting from a reaction between AZT and benzodiazepines and the likelihood of frequent use of the combination of these drugs in patients with HIV infection.

Benzodiazepines (such as oxazepam) are among the most frequently prescribed class of drugs and are commonly used therapeutically for patients with chronic disease. This study is important because of the potential for toxicity resulting from a reaction between AZT and benzodiazepines and the likelihood of frequent use of the combination of these drugs in patients with HIV infection.

Patients are studied to determine oral and intravenous AZT and single oral dose oxazepam pharmacokinetics. Patients then take AZT and oxazepam together to determine if interactions between the drugs occur.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Required:

* Stable prescribed dosage of zidovudine (AZT), = or \> 500 mg/day.

Allowed:

* Prophylaxis for Pneumocystis carinii pneumonia (PCP) with aerosolized pentamidine.
* Erythropoietin.

Patients must be:

* HIV positive by ELISA and Western blot.
* Currently taking a stable prescribed dosage of 500 mg/day of zidovudine (AZT).

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

* Allergy to benzodiazepines or a previously documented intolerance to zidovudine (AZT) therapy of = or \< 600 mg/day.
* Significant underlying medical condition that could impair continuous participation in study.
* Malabsorption syndrome (3 or more loose stools a day for at least 4 weeks associated with an unintentional weight loss of at least 10 percent of body weight).

Concurrent Medication:

Excluded:

* Oral contraceptives.
* Cytotoxic chemotherapy.
* Ganciclovir.
* Flucytosine.
* Probenecid.
* Opiates.
* Valproic acid.
* Sulfa drugs.
* Sucralfate.
* Dapsone.
* Rifampin.
* Antacids within 2 hours of zidovudine (AZT) dose.
* Isoniazid.
* Ketoconazole.
* Pyrimethamine.
* Clindamycin.
* Aspirin.
* Ibuprofen.
* Investigational drugs not specifically allowed.

Patients with the following are excluded:

* Allergy to benzodiazepines or a previously documented intolerance to zidovudine (AZT) therapy of = or \< 600 mg/day.
* Significant underlying medical condition that could impair continuous participation in study.
* Unable to take oral medication reliably.

Prior Medication:

Excluded within 30 days of study entry:

* Antiretroviral agents other than zidovudine (AZT).
Kenosha County Falls Prevention Study

Intensive falls prevention programs have been shown to be effective in reducing falls; however, a number of practical programs, based in community setting have not been successful at reducing rate of falls. The purpose of this study was to test, in a randomized, controlled trial, the efficacy of this intermediate-intensity, individual, multifactorial model to reduce falls. It was hypothesized that more contacts would lead to greater adherence and efficacy in reducing falls.


Eligibility Criteria:
Inclusion Criteria:

* aged 65 and older
* a history of two falls in the previous year or one fall in the previous two years with injury or gait and balance problems
* independently living in Kenosha County

Exclusion Criteria:

* unable to give informed consent with no related caregiver in the home
* enrolled in hospice
* living in an assisted-living facility
* expecting to move away permanently from the area
Sensory-Evoked Cortical Gamma Oscillation

The purpose of the study is to investigate the efficacy of cortical gamma oscillation on visual sensory processing and cognitive function in Alzheimer's Disease (AD) patients by combining a therapeutic sensory stimulation device capable of evoking 40-Hz gamma oscillation via non-invasive visual and auditory stimulation with pre-established markers of cortical network activity, i.e., electroencephalography (EEG) and event-related potentials (ERP), to evaluate the applicability of the 40-Hz multimodel sensory stimulation as a novel therapeutic approach for treatment of AD patients.

The central hypothesis of the study is that sustained 40Hz gamma oscillatory sensory stimulation therapy will improve cognitive function in patients with AD. The further hypothesis is that the improvement in cognitive function will result from improved connectivity and cortical network function as measured by EEG and ERP.

The hypotheses will be tested by the following:

1. - Elucidate the immediate impact of gamma oscillations on sensory processing and cognitive function by assessing cognitive function and cortical network function prior to the introduction of sensory stimulation and comparing it to post-therapeutic assessments immediately following the acute administration of therapy on visual processing.
2. - Explore the short and long-term therapeutic benefits of a sub-chronic (8 weeks) treatment by assessing cognitive function and cortical network connectivity immediately after the 8 week sensory stimulation therapy. If significant changes are observed between pre-therapy and post-therapy neurophysiologic data for an individual subject, neurophysiological testing will be repeated 4 weeks following the conclusion of therapy.
3. - Investigate the correlation between neurophysiology and cognitive function by assessing cognitive function and neurophysiological measures of cortical network activity at multiple time points to determine if therapeutic changes in one domain reflect changes related to the other domain.

Eligibility Criteria:
Inclusion Criteria:

* Individuals ages 60 and older with established diagnosis of Alzheimer's Disease as defined by the current consensus criteria for AD (Albert et al, 2011, Jack et al, 2011; McKhann et al, 2011)
* Fluent and literate in English language
* Able to consent for themselves based upon the MacArthur Competence Assessment Tool for Clinical Research
* Patients with a pre-existing positive A(beta)-PET and/or CSF tau/A(beta) markers or willingness to undergo a Lumbar Puncture (LP) with these results

Exclusion Criteria:

* Not fluent and literate in English
* Severe dementia
* Other medical conditions/neurodegenerative disease that could significantly impair cognitive abilities
* Cardiac pacemakers or any other implants that may not be compatible with MRI
* Cognitively impaired to the point the patient is unable to consent for themselves
* Claustrophobic to the point that medication is required
Early Socioemotional Intervention for Children With Autism Spectrum Disorder in Hong Kong and Mainland China

This study aims to develop a culturally-sensitive parent-training intervention to enhance socioemotional functioning of young children (aged 3-6) with Autism Spectrum Disorder (ASD) in Mainland China. The investigators will conduct randomized controlled trials to evaluate the effectiveness and feasibility of this program in a pilot study and then a large-scale community-based study in Shenzhen, China, to examine the generalizability of the treatment outcomes of this intervention for Chinese children with ASD.


Eligibility Criteria:
Inclusion Criteria:

* Children aged 3-6
* Living in Shenzhen, Mainland China
* Diagnosed with ASD or suspected of having ASD
Effect of Systemic Cooling in Vasospasms

This study tests whether women with Vasospastic Syndrome (VS) react more intensive than controls with distal vasomotions and choroidal blood flow changes to internal cooling/warming and external cooling/warming.

Distal vasomotions and choroidal blood flow changes to internal cooling/warming and external cooling/warming was studied in VS and controls.Core cooling was induced by drinking of 250g ice/water mixture (4°C). Core warming was induced by drinking of 250g warm water (55°C). The study was controlled with respect to posture and room temperature.

Eligibility Criteria:
Inclusion Criteria:

* women
* luteal phase or contraceptives
* 19-35 years

Exclusion Criteria:

* somatic diseases
* psychiatric diseases
* BMI \> 25
* BMI \< 18