cyrilzakka/clinical-trials huggingface dataset:
Characterization of the Adherence Threshold for HIV Suppression of a Kaletra-based Regimen

The hypothesis of this study is that the level of adherence necessary to achieve HIV virologic suppression with a ritonavir boosted protease inhibitor regimen (i.e. lopinavir/ritonavir) is less than the 95% rate observed in the published literature with unboosted regimens.

The existing dogma is that patients receiving highly active antiretroviral therapy (HAART) to treat their HIV infection must take at least 95% of prescribed doses in order to maintain full suppression of viral replication. This belief is largely based on a single study that was performed between 1997 and 1999 (Ann Int Med 2000;133:21-30). The vast majority of patients in this study were receiving regimens based on either indinavir, nelfinavir, ritonavir, or saquinavir. All of these agents have relatively short half-lives, and therefore must be taken on time two or three times per day. Newer medications such as lopinavir/ritonavir (Kaletra) feature much more favorable pharmacokinetic profiles. On the basis of improved pharmacokinetics, there is reason to believe that regimens built around such agents may be more forgiving of missed medication doses.

This study aims to enroll 90 patients from the MMC I.D. Clinic who are either receiving or are about to receive Kaletra. Patients who agree to participate will be furnished with a MEMS cap, a bottle cap that electronically records each time that the bottle is opened and stores the data for computer download, and will undergo electronic monitoring of their Kaletra adherence for a period of siz months. Adherence data will not be reviewed during the study, but at study end (and at interim time points), the investigators will analyze the MEMS cap data from patients who have completed the study in order to determine the threshold value of adherence necessary to achieve satisfactory rates (i.e. 70-80%) of complete virologic suppression.

An additional aim of the study is to collect specimens from patients receiving Kaletra based regimens who experience virologic failure and to archive them for possible studies of genotypic and phenotypic resistance in the future.

Eligibility Criteria:
Inclusion Criteria:

* HIV infection
* Receiving twice daily Kaletra at an FDA approved dosage
* Age\>18 years
* CD4 and viral load available within seven day of enrollment
* Patient willingness to accept MEMS cap monitoring
* HIV genotype within 60 days of enrollment for patients with viral load\>1000
* Patient willingness to grant informed consent and complete five study visits

Exclusion Criteria:

* Provider or patient deem it unlikely that Kaletra therapy will continue for the ensuing 24 weeks
* Prescription of any medication that is contraindicated for Kaletra recipients
The Daytime Circadian Rhythm in Exhaled Volatile Organic Compounds in People Living Without and Diabetes

Exhaled volatile organic compounds will be measured during daytime with the goal to identifying circadian variability. The study incudes three subgroups: people without diabetes, people with type 1 diabetes, and people with type 2 diabetes. A total of 60 people will be recruited for the study.


Eligibility Criteria:
Inclusion criteria

Subgroup 1:

* Age 18 or older
* HbA1c below 6.5%
* Written informed consent

Subgroup 2:

* Age 18 or older
* T1D (Type 1 diabetes) with MDI (multiple daily injection) or CSII (Continuous subcutaneous insulin infusion therapy) therapy \>1 year
* Written informed consent

Subgroup 3

* Age 18 or older
* T2D (Type 2 diabetes) with oral antidiabetic medication or insulin therapy
* Written informed consent

Exclusion criteria

* Pregnancy or breastfeeding
* Smoking (last cigarette less than 6 months ago)
* Any chronical lung and intestinal disease diagnosis (such as intestinal bowel disease (IBD); asthma; COPD (chronic obstructive pulmonary disease); lung cancer, ...)
* Coeliac disease
* Lactose and fructose intolerance
* Any acute disease diagnosis (such as viral or bacterial infection)
* Drinking habit of more than four units of alcohol per day
* Current inhaled medicines treatments
* Antibiotic treatment in the previous 4 months
Respiratory and Hemodynamic Targets During General Anesthesia

This trial is an investigator-initiated, multicenter, randomized, factorial, single-blind trial of multiple hemodynamic and respiratory targets during general anesthesia. These targets include blood pressure, positive end expiratory pressure, tidal volume, and fraction of inspired oxygen. Patients will be randomized to different targets using a factorial design, i.e., each patient is simultaneously randomized to four interventions. There will be five enrolling sites in the Central Denmark Region. 480 high-risk patients will be enrolled.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* American Society of Anesthesiologists (ASA) classification 3 to 5
* Planned endotracheal intubation with positive pressure ventilation
* Expected operating time ≥ 90 minutes
* Certain types of surgery

Exclusion Criteria:

* Inability to obtain consent (e.g., patient is unconscious, hyperacute surgery)
* Known or suspected pregnancy
* Out-patient/same-day surgery
* Intubated prior to surgery
* Clinical judgement by the anesthesiologist that any of the interventions could be potentially harmful to the patient
Effect of Intrathoracic Pressure Regulation on Decreased Cerebral Perfusion

The purpose of the study is to evaluate the physiological response to application of the Intrathoracic Pressure Regulator (ITPR) in patients with compromised cerebral circulation. The study will evaluate the physiological response to intrathoracic pressure regulation (IPR) therapy in hemodynamically stable patients with compromised cerebral circulation who are on ventilatory support.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age
* intubated and mechanically ventilated on a volume controlled mode
* head injury or other intracranial pathology and compromised cerebral perfusion
* arterial line in place or alternative with continuous pressure monitoring
* SpO2 ≥90%
* mean arterial pressure \>55
* admission to ICU or about to undergo neurosurgery with planned placement of an invasive intracranial pressure monitor
* inclusion presents no significant delays to planned emergent neurosurgery
* prior written informed consent

Exclusion Criteria:

* cardiac or pulmonary injury
* confirmed pneumothorax or hemothorax
* serious neck injury resulting in neck swelling with jugular venous compression
* evidence of ongoing uncontrolled bleeding
* respiratory disease such as COPD, interstitial lung disease, or other parenchymal or pulmonary vascular disease
* marked hypertension at time of device use defined as systolic blood pressure \>180 mmHg
* congestive heart failure
* women with positive serum or urine pregnancy test or breast feeding
Development and Testing of a Mobile App to Scale Delivery of Cognitive-behavioral Therapy for Avoidant/Restrictive Food Intake Disorder

Avoidant/restrictive food intake disorder (ARFID) is a serious and impairing eating disorder - occurring in up to 4% of adults - for which most individuals do not have access to treatment. The proposed study aims to develop and test a mobile app to scale delivery of cognitive-behavioral therapy for ARFID. Knowledge gained will contribute to the development of a clinically accessible, scalable, inexpensive treatment for ARFID, a highly impairing disorder for which there are significant barriers to care access.


Eligibility Criteria:
Inclusion Criteria:

1. Current avoidant/restrictive food intake disorder based on DSM-5 criteria
2. Must not have completed face-to-face CBT-AR at the Eating Disorders Clinical and Research Program at Massachusetts General Hospital
3. Ability to speak, write, and understand English
4. Residence in the United States
5. Access to an internet-connected smartphone device

Exclusion Criteria:

1. Underweight status (i.e., BMI \< 18.5 kg/m2)
2. Complete lack of oral intake or dependence on supplemental feeding
3. Feeding or eating disorder other than ARFID
4. Any comorbid clinically significant disorder that would require attention beyond the study treatment

6. Medical instability requiring inpatient care according to the American Psychiatric Association 2023 treatment guidelines for eating disorders 7. Medical history of intellectual disability 8. Illiteracy
Colorectal Cancer Screening in Average-risk Population: Immunochemical Fecal Occult Blood Testing Versus Colonoscopy

Aims:

1. To compare the efficacy of biennial immunochemical fecal occult blood test (iFOBT) versus colonoscopy every 10 years for the reduction of colorectal cancer-related mortality at 10 years in average-risk population.
2. To determine the compliance and complications associated with both strategies.

Methods: Multicenter, randomized, controlled study in 8 Spanish regions (Aragón, Canarias, Catalunya, Euskadi, Galicia, Madrid, Murcia and Valencia).

Study groups:

* Group I: iFOBT (OC Sensor®) in one stool sample, followed by colonoscopy when a positive result.
* Group II: colonoscopy.

Sample-size calculation: 27,749 subjects in each study group (total: 55,498).


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 50-69 years

Exclusion Criteria:

* Personal history of colorectal cancer, colorectal adenoma, colorectal polyposis, or inflammatory bowel disease
* Family history of colorectal polyposis, Lynch syndrome or familial colorectal cancer (2 or more first-degree relatives diagnosed with colorectal cancer or one first-degree relative diagnosed with colorectal cancer before the age of 60)
* Severe comorbidity
* Previous total colectomy
* Not signed informed consent to participate
Intense Pulsed Light in Meibomian Gland Dysfunction

Meibomian gland dysfunction (MGD) is a major cause of dry eye disease (DED). Up to 86% of patients suffering from DED also show signs of MGD. Traditional treatment of MGD is based on eye lid hygiene and massage in combination with intensive usage of lubricants.

Recently, a novel technology the intense pulsed light (IPL) therapy was introduced, which shows promising results in patients with meibomian gland dysfunction. Originating from field of dermatology, subjecting improvement of dry eye symptoms was recognized after the treatment of facial rosacea using IPL. Different hypotheses exist how IPL treatment might improve the situation in the dry eye patient. Warming of the eyelid, due to the light application and reduction of bacterial load are two possible mode of actions. Further, the used wavelengths in IPL may be modified that the light is only absorbed by oxygenated haemoglobin, which lead to an obliteration of telangiectasia and reduced inflammation on the lid margin. This principal is applied in the treatment of facial rosacea.

Aim of this study is to investigate the effect of IPL therapy in patients with MGD on dry eye parameters as well as subjective complaints.


Eligibility Criteria:
Inclusion Criteria:

* Age older than 18 years
* Presence of meibomian gland dysfunction at any stage
* Presence of meibomian glands on each lower eyelid's Meibography

Exclusion Criteria:

* Fitzpatrick Skin Type VI
* Usage of eye drops other than lubricants (e.g. antibiotics, steroids, cyclosporin-A)
* Usage of systemic antibiotic therapy
* Any pathology of the ocular surface except dry eye disease (e.g. corneal scarring, cornea ectasia)
* Ocular surgery within prior 3 months
* Ocular injury within prior 3 months
* Ocular herpes of eye or eyelid within prior 3 months
* Active ocular infection
* Active ocular inflammation or history of chronic, recurrent ocular inflammation within prior 3 months
* Eyelid abnormalities that affect lid function
* Ocular surface abnormality that may compromise corneal integrity
* Pregnancy
Safety, Tolerability and Pharmacokinetics of Danoprevir/r in Healthy Volunteers China

The purpose of this study is to evaluate the Pharmacokinetics of Danoprevir in single dose (100mg QD on day 1, day 4 and day 14) and Ritonavir-boosted Danoprevir (100mg QD on day 4 and day 14) in single and multiple doses (100mg BID on day 5 -day 13) in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide written informed consent
* Healthy men or women based on history, physical examination, laboratory examination and ECG.
* Negative serum or urine pregnancy test result (sensitivity of 25 mIU or better) for women with childbearing potential within the 24-hour period before the first dose of study drugs
* Female patients with childbearing potential (menopause within 1 year) must agree to use two reliable forms of effective non-hormonal contraception (i.e., condoms, cervical barriers, intrauterine device, spermicides, or sponge), at least 1 of which must be a physical barrier method, during treatment and for at least 6 months following the last dose of ribavirin
* All male patients with female partners of childbearing potential must use two reliable forms of effective contraception (combined) during treatment and for 6 months following the last dose of ribavirin
* Others as specified in the detailed protocol

Exclusion Criteria:

* Have medical history, or has disease, such as cardiovascular system, respiratory system, endocrine and metabolic system, urinary system, digestive system, blood system, nerve system disease or psychiatric disease and acute or chronic infectious diseases and malignant tumors.
* Has a history of drug or food allergy.
* Positive hepatitis A antibody，positive hepatitis B surface antigen， positive hepatitis C antibody，syphilis antibody or HIV antibody at screening.
* Had gastrointestinal surgery, vagotomy, intestinal resection or any possible interference with gastrointestinal peristalsis, pH or absorbed by surgery.
* Pregnant, lactating or menstrual period and unwilling to reliable contraception period women of childbearing age.
* Female partners have fertility and reliable contraceptive measures of men.
Clinical Pathways for the Management of Acute Coronary Syndromes - Phase 3,CPACS-3

The burden of chronic, non-communicable disease, of which cardiovascular disease comprises a significant component, has increased rapidly and substantially in China over recent years. Over the coming decades China is predicted to experience a 69% increase in acute coronary disease(ACS), amounting to nearly 8 million additional events. A recent randomized trial of more than 15,000 patients with acute coronary syndromes, the second phase of Clinical Pathway for acute coronary syndromes in China (CPACS-2) study, showed that a quality improvement initiative could improve aspects of hospital care, including the proportion of patients discharged on appropriate medication. The study also identified a number of barriers to improved care including out of pocket costs and administration systems. However, the study was not able to determine the impact on clinical outcomes or the cost-effectiveness of the intervention. The aim of the third phase of the Clinical Pathway for acute coronary syndromes in China (CPACS-3) study is to determine whether a complex intervention comprising a clinical pathway for ACS management in combination with a number of physician and patient-oriented education tools can improve the quality of care and health outcomes among ACS patient admitted to resource-limited (provincial) hospitals. The effectiveness of the intervention will be evaluated using a cluster randomized trial (stepped wedge design) of ACS patients admitted to 104 hospitals in China. The study will incorporate two additional components (1) a qualitative substudy to identify the barriers and enablers to improved care and (2) a study comparing the cost-effectiveness of the intervention compared to usual care, from the perspective of the health care provider. The study will be conducted in conjunction with the Chinese Ministry of Health and the Chinese Society of Cardiology. The findings from CPACS3 will be able to inform health policy-makers about the extent to which quality improvement initiatives can reduce the risk of death and disability among the millions of ACS patients admitted to hospitals in China each year.


Eligibility Criteria:
Inclusion Criteria:

* admitted to participating hospitals
* diagnosed as Acute Coronary Syndromes(ACS) at the time of death or discharge
* aged 18 years or older

Exclusion Criteria:

* death happened within 10 mins after arriving hospital
* ACS happened during hospitalization due to other health problem
* patients already registered in the database
Serum Level of Bioactive Mediators and Urinary Biopyrins in Psoriasis

1. Assess the level of lipid mediators in patients with psoriasis
2. Assess the urinary level of biopyrins as New marker of oxidative stress in patients with psoriasis
3. Correlate the serum level of bioactive lipid mediators and urinary level of biopyrins with Psoriasis Area and Severity Index

Psoriasis is acommon immune mediated inflammatory skin disorder of complex pathomechanisms which is generically conditioned and influenced by environmental factors

Eligibility Criteria:
Inclusion Criteria:

* age from12 to 80 and both sex

Exclusion Criteria:

* patients with other dermatological disorders
Procellera® Compared to Standard of Care Treatment in Mitigating Biofilm Formation in Acute Trauma and Burn Wounds

The objective of the study is to evaluate Procellera® , a novel FDA approved antimicrobial wound dressing in a prospective, randomized, controlled clinical study. The hypothesis is that when the dressing is moistened, the low electric field created by moisture-activated elemental silver and zinc electro-couple will prevent formation of biofilm in wounds or to disrupt existing biofilm.

The healing of traumatic wounds, to include burns, can be compromised by the presence of infection so efforts are made to prevent or diagnose infection early in order to mitigate the negative impact on healing. Electric stimulation has previously been shown to have both bacteriostatic and bactericidal effects in wounds. Until now, administering low intensity electric field/micro-current as a therapy to mitigate biofilm infection and to improve wound healing was not feasible. In this study the investigators will use Procellera® , a FDA approved fabric based wireless electroceutical dressing (WED) consisting of a silver-zinc electro-couple for the prevention of wound biofilm formation. The dressing generates a low electric field (\~1V) upon activation by a moist environment, which mitigates biofilm formation and promotes wound healing. The objectives of the study are to evaluate the efficacy of a wireless electroceutical dressing to prevent the formation or disrupting existing biofilms. The investigators will conduct a prospective, randomized controlled clinical trial using the Procellera® dressing compared to the standard of care. Treatment sites will be randomized to either receiving Procellera® or the standard of care treatment. Objective measurements and assessments will be completed during subject follow-up visits for up to one month post treatment. This includes biopsies to calculate bacterial load by assessing colony forming unit (CFU) count and bacterial film visualization using scanning electron microscopy, histology, clinical assessment of infection, Transepidermal Water Loss (TEWL) and wound photography.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years of age
* Willing and able to provide informed consent
* Participant has acute partial-thickness or full-thickness wounds caused by trauma or partial-thickness burns that are ≥ 300 cm2 in size in one contiguous area or two separate wound sites ≥ 150 cm2 each

Exclusion Criteria:

* Pregnancy
* Prisoner
* Active malignancy or immunosuppressive therapy
* Current systemic steroid use
* Known allergy or sensitivity to silver or zinc
* Participant's proposed study wound site has any of the following conditions:
* Location is on the hands, face or feet
* Full-thickness burn wounds
* Exposure of visceral organs
* Exposure of hardware or prosthetic exposure
Minimally Invasive Mitral Valve Replacement Versus Conventional Approach: Comparison of Early Postoperative Outcomes.

The term minimally invasive mitral valve surgery has been reported (MIMVS) by American Heart Association and referred to a collection of new techniques. All of these new techniques aiming to reduce surgical trauma by minimizing surgical incision, modified perfusion methods and use of new instruments . The right anterior mini-thoracotomy is the most common approach, next to it the lower mini-sternotomy approach, then the parasternal incision or the left posterior thoracotomy approach .

Technically MIMVS is more complex, requires a special learning curve and associated with higher Incidence of neurological events, aortic dissection, groin complications and infection despite all these benefits . MIVS also has controversies among cardiac surgeons, because it makes the exposure worse and requires a more complex surgery, which may lead to a less satisfying effect


Eligibility Criteria:
Inclusion Criteria:

* Patients with isolated rheumatic mitral valve disease in need for mitral valve replacement.

Exclusion Criteria:

* Redo mitral valve replacement.
* Emergency mitral valve replacement (non-rheumatic cases).
* Patients who have combined other valve diseases e.g. (severe Aortic Regurgitation).
* Patients need Tricuspid valve repair or replacement.
* Severely calcified mitral valve disease (mitral annular calcification).