cyrilzakka/clinical-trials huggingface dataset:
Effect of Sleep Extension on Ceramides in People with Overweight and Obesity

The overall goal is to determine how a sleep extension intervention (increasing time in bed) in individuals who maintain less than 6.5 hours sleep per night affects their plasma ceramides and insulin sensitivity. Participants will undergo a randomized controlled trial, with sleep extension (intervention) and healthy lifestyle (control) groups. The sleep extension is designed to increase participant's time in bed by 2 hours per night. Alternatively, the control group will receive basic health information (e.g., physical activity, goal setting, and nutrition when eating out).

A randomized controlled trial with real-world sleep extension in adults with overweight and obesity who habitually obtain short sleep duration will be conducted. Group allocation will be 1:1 and research staff and participants will be blinded until the conclusion of the baseline segment. The sleep extension group will receive counseling and instruction to increase nightly time in bed by 2 hours per night. Participants randomized to control will maintain their habitual sleep habits in their home environment. The intervention segment will last 8 weeks regardless of group assignment. Both groups will have equal contact time with the study team.

Prior to enrollment participants will complete a clinical overnight sleep disorders screening. Baseline consists of an \~1-week ambulatory real-world monitoring segment. Following baseline, participants will be randomized 1:1 to either the sleep extension or control group for 8 weeks at home (intervention segment). Throughout the study, sleep duration will be monitored using an actiwatch wrist-device and a daily electronic sleep log. Following the baseline and intervention segments participants will complete rigorous overnight laboratory visits to assess plasma ceramides (targeted metabolomics assay) and insulin sensitivity (hyperinsulinemic-euglycemic clamp).

Eligibility Criteria:
Inclusion Criteria:

1. Age: 18-45 years old; equal numbers of men and women
2. Body mass index (BMI): 27.5-34.9 kg/m2
3. Sleep Habits: habitual self-reported average total sleep time (TST) \<6.5 hours per night for prior 6 months

Exclusion Criteria:

1. Clinically diagnosed sleep disorder or major psychiatric illness
2. Evidence of significant organ dysfunction or disease (e.g., heart disease, kidney disease)
3. Clinically diagnosed diabetes or fasting plasma glucose ≥126 mg/dL or HbA1c ≥6.5%
4. Use of prescription drugs or substances known to influence sleep or glucose metabolism, or anticoagulant medications.
5. Cancer that has been in remission less than 5 years
6. Pregnant/nursing, experiencing menopause or post-menopausal
7. Shift-work: current or history of within last year
8. Weight change: \>10% of body weight over prior six months
9. Current enrollment in weight loss or physical activity program like the Diabetes Prevention Program
10. Currently smoking
11. Alcohol intake\>14 drinks per week or \>3 drinks per day
A Single Intravitreal Injection of rAAV2-ND4 for the Treatment of Leber's Hereditary Optic Neuropathy

This study is meant to evaluate the safety and efficacy of rAAV2-ND4 treatment for Leber hereditary optic neuropathy with the G11778A mutation in mitochondrial DNA.

Leber's Optic Hereditary Neuropathy (LHON) is a maternally inherited ocular disorder primarily associated with mutations in mitochondrial DNA. The disease is a common cause of blindness in both eyes of affected teenagers and young adults. There is currently no approved effective treatment for LHON.

In 2011, the first LHON gene therapy investigator-initiated study was conducted (registered in December 2010 with ClinicalTrials.gov Identifier NCT01267422) to explore the safety and efficacy of gene therapy for LHON. The gene therapy was a recombinant adeno-associated virus serotype 2 containing human mitochondrial ND4 (MT-ND4) gene (rAAV2-ND4). By 36 months of follow-up, six out of nine patients who received the rAAV2-ND4 intravitreal injection experienced clinically significant vision improvement and no adverse events were observed.

This is an open-label, single-arm, multi-center study to further evaluate the safety and efficacy of rAAV-ND4 in the treatment of LHON patients with G11778A mutation. All patients will be treated with a single intravitreal injection rAAV-ND4, with dose 1 × 10\^10 vg/0.05 mL in one of the eyes.

Eligibility Criteria:
Inclusion Criteria:

1. Patients carry the mitochondrial point mutation at 11778, which is consistent with the diagnostic criteria for LHON.
2. No apparent eye sight improvement in LHON patients or any other treatment within the past year.
3. Eyesight of both eyes is below 0.3.
4. Patients signed written informed consent.
5. Patients are between the ages of 10 and 65 years old and able to tolerate the gene therapy procedure which includes local anesthesia.
6. Patients are willing to follow the doctor's instructions and to consult the doctor at prescribed times.
7. Patient's physical examination results are all normal, including liver function, kidney function, routine blood test, routine urine test, complete immunological test, and humoral immune response.

Exclusion Criteria:

1. Patients who are wearing a cardiac pacemaker, suffering from severe heart, lung or kidney function failure, various hemorrhagic diseases, acute infectious diseases, high fever, or convalescing after heart surgery or who are pregnant are excluded.
2. Patients who are participating in other clinical studies are excluded.
3. Patients who suffer from a diagnosed mental problem are excluded.
4. Patients who suffer from chronic diseases such as diabetes and hypertension are excluded.
5. Patients who show abnormal test results such as positive AAV2 humoral immune response (positive means that the AAV2 neutralizing antibody assay of patient was significant different when comparing free serum with 1:20 serum concentrations) and abnormal human T lymphocyte subsets CD3+, CD3+/CD4+ and CD3+/CD8+ prior to gene therapy surgery are excluded.
Effects of Chronobiology-guided Lifestyle Interventions on Insomnia Severity, Cognitive Performance, and Sleepiness

Poor sleep is closely related to circadian misalignment; shift workers often experience shift work disorder characterized by excessive sleepiness and recurrent shift work schedules-associated insomnia. This study aims to examine the effects of a program of chronobiology-guided lifestyle interventions (CGLI) on insomnia severity, cognitive performance (psychomotor vigilance and processing speed), and sleepiness in female nurses undertaking rotating-shift work.

This study will use a parallel-group, randomized, assessor-blind, wait-list controlled design to determine the effects of a program of multimodal lifestyle interventions based on chronobiology, consisting of timed bright light exposure, meal timing manipulations, and sleep hygiene education on insomnia severity, cognitive performance (psychomotor vigilance and processing speed), and sleepiness in female nurses undertaking rotating-shift work.

Eligibility Criteria:
Inclusion Criteria:

1. Females aged 20 to 60 who work full time as a nurse and work a 3-shift rotation, including day shifts, evening shifts, and night shifts in the most recent 6 months.
2. Participants must complain of insomnia symptoms and/or sleepiness in relation to shift work schedule for at least 3 months.
3. Participants must have10 workdays (evening or night shift) within a 14-day period during the study period.

Exclusion Criteria:

1. Active physical diseases.
2. Moderate to severe psychopathology.
3. Medications or treatments that may affect sleep.
4. Pregnant or breastfeeding.
5. Participants must be free of ophthalmic pathology, eye surgery, and diseases affecting the retina or taking photosensitizing drugs.
6. Participants who have been diagnosed with sleep-disordered breathing will be excluded. Sleep-disordered breathing such as obstructive sleep apnea (OSA) will be screened using the snoring, tiredness, observed apnea, high BP, BMI, age, neck circumference, and male gender (STOP-BANG) questionnaire.
Lowering InterLeukin-1 Receptor Antagonist Concentrations After TB Treatment Onset

Despite marked improvements in the diagnosis of tuberculosis there are difficulties in diagnosing and monitoring treatment outcome among TB patients. The use of immunological biomarkers alone or in combination with other clinical parameters could predict early the response to TB treatment. The aim of this study is to demonstrate that the IL-1 receptor antagonist (IL-1Ra) concentrations significantly decrease within two weeks following TB treatment initiation in adults with active documented TB.

The HIV/AIDS epidemic and Tuberculosis (TB) remain important challenges for global public health and are strongly linked. Despite marked improvements in the diagnosis of tuberculosis, there are difficulties in diagnosing and monitoring treatment outcome among TB patients. The use of immunological biomarkers alone or in combination with other clinical parameters could better predict the response to TB treatment. The aim of this study is to demonstrate that the IL-1 receptor antagonist (IL-1Ra) concentrations significantly decrease within two weeks following TB treatment initiation in adults with active documented TB. This is a proof-of-concept study, among 100 patients (50 HIV positive and 50 HIV negative) with documented active TB, in Cambodge and Côte d'Ivoire. Patients recruited for this study will receive the standard TB treatment per their respective national treatment guidelines. Plasma samples will be collected at baseline (initiation of TB treatment), weeks 1, 2, 4 and 8 to measure IL-1Ra, sCD163 and IP-10.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Evidence of TB, with: positive Xpert MTB/RIF
* For HIV infected patients:

  * ART-naïve
  * Regardless of CD4 cell counts
* Written informed consent
* Willingness to be followed up in the study clinics for 6 months after inclusion

Exclusion Criteria:

* Mycobacterium tuberculosis strain resistant to rifampin with Xpert MTB/RIF
* Ongoing TB treatment
* Overt evidence of other ongoing opportunistic infections
* Pregnant or breastfeeding women
* Karnofsky score ≤ 30
* Person unable to understand the study
* Person currently participating in clinical trial
* Females on oestroprogestative and progestative hormonal contraception
Extension of Phase 3 Gene Therapy for Painful Diabetic Neuropathy

The purpose of this study is to explore the overall safety profile and durability of efficacy of Engensis (VM202) in painful diabetic peripheral neuropathy.

All subjects still in follow-up for the VMDN-003 study or who have completed the Day 270 visit within the prior 90 days will be approached to enroll in the long-term safety extension study.

In the phase III VMDN-003 study, subjects received 2 treatments of either Engensis (VM202) or placebo administered as intramuscular injections into bilateral calves on Days 0 and 14, and Days 90 and 104. Primary efficacy was evaluated 90 days following the first injection. The growth potential for Hepatocyte Growth Factor make long-term follow-up important both for safety and efficacy: in order for Engensis to be a candidate for chronic treatment of Painful Diabetic Peripheral Neuropathy, it must be demonstrated not to induce unexpected adverse events with repeated dosing; and the potential for reversal or stabilization of diabetic neuropathy using only one or two treatments of Engensis may make it especially attractive compared to current treatments which must be taken daily for the duration of the disease. A safety extension to the VMDN-003 study is therefore warranted.

Eligibility Criteria:
Inclusion Criteria:

1. Were randomized and dosed in the VMDN-003 study
2. Received all intramuscular injections of study drug on Days 0, 14, 90, and 104 in the VMDN-003 study
3. Were in follow-up for the VMDN-003 study or had completed Day 270 within the last 90 days prior to signing consent

Exclusion Criteria:

1. Were using an investigational drug or treatment
2. Were unable or unwilling to give informed consent
TMS-induced Plasticity Improving Cognitive Control in OCD

Repetitive transcranial magnetic stimulation (rTMS) has been shown in several previous clinical trials to be an effective treatment for obsessive-compulsive disorder (OCD). However, the neural working mechanisms of rTMS in OCD are unknown, and the optimal stimulation sites have not yet been established. Our study aims to compare the clinical and neurobiological effects of three different rTMS stimulation protocols in OCD patients. 8 weeks of rTMS therapy will be delivered in combination with cognitive behavioural therapy. Multimodal neuroimaging will be carried out before and after treatment in order to demonstrate the neurobiological effects of the therapy.


Eligibility Criteria:
Inclusion Criteria:

OCD patients:

* Age between 18 and 65
* Primary DSM-5 diagnosis of OCD
* Moderate to severe OCD symptoms (expressed as a minimum score of 16 on the Yale - Brown Obsessive Compulsive Scale (YBOCS)
* Unmedicated or stable dose of medication for at least 12 weeks prior to randomisation - with no plans to change dose during the study period
* At least 1 previous attempt at cognitive behavioural therapy (CBT) in lifetime
* At least 1 previous attempt with serotonergic medication or strong preference for non-pharmacological treatment
* Capacity to provide informed consent

Healthy controls (baseline measurements only):

* Age between 18 and 65
* Capacity to provide informed consent

Exclusion Criteria:

OCD patients:

* MRI exclusion criteria (metal in body, pregnancy)
* TMS exclusion criteria (metal in body, history of epilepsy)
* Schizophrenia, bipolar disorder, active suicidal ideation, use of antipsychotics within last 12 weeks
* previous experience with rTMS as treatment

Healthy controls:

* Current Diagnostic and Statistical Manual (DSM)-5 diagnosis
* Personal history of DSM-5 diagnosis
* use of psychotropic medications within last 12 months
* 1st degree family member with OCD
* MRI exclusion criteria (as above)
* TMS exclusion criteria (as above)
Fungal Infection in Patients in Intensive Care Units

Predictors of fungal infection in non-neutropenic patients in intensive care units and the aim of the study is To evaluate the frequency of fungal infection in non-neutropenic patients in Intensive Care Units.

To evaluate the risk factors of fungal infection in these patients.

The incidence of candidemia in the overall population ranges from 1.7 to 10 episodes per 100,000 inhabitants and Candida is one of the ten leading causes of bloodstream infections in developed countries. An estimated 33-55% of all episodes of candidemia occur in intensive care units (ICU) and are associated with mortality rates ranging from 5% to 71%. Candida fungemia may have an endogenous or an exogenous origin, and in recent years a growing proportion of episodes of candidemia have been caused by Candida species other than albicans. The most important independent conditions predisposing to candidemia in ICU patients include prior abdominal surgery, intravascular catheters, acute renal failure, parenteral nutrition, broad-spectrum antibiotics, a prolonged ICU stay, the use of corticosteroids and mucosal colonization with Candida. In recent years, several studies have shown that ICU patients with mucosal Candida colonization, particularly if multifocal, are at a higher risk for invasive candidiasis, and that colonization selects a population amenable to antifungal prophylaxis or empirical therapy. Candidemia in ICUs is associated with a con- siderable increase in hospital costs and length of hospital stay.

Invasive fungal infection (IFI) is a grave infection associated with serious effects in patients with chronic diseases including liver cirrhosis. The diagnosis of IFI re- quires histopathological evidence of tissue invasion, or isolation in blood cultures, or isolation from a normally sterile body fluid or site, with samples collected intra-op- eratively or by percutaneous needle aspiration. Awareness of IFI has been increased in clinical practice with the increased survival of patients in immunocompromised states. Such infections are associated with a high morbidity and significant mortality, requiring early diagnosis and appropriate treatment, but also optimal prophylaxis in patients at high risk.

Globally, several studies had assessed fungal infections in non-neutropenic patients, however, to our knowledge, searching for fungal infections in these patients are un- derestimated in our locality.

Eligibility Criteria:
Inclusion Criteria:

* Adult Patients with liver cirrhosis that will be clinically suspected to have in- fection.

Exclusion Criteria:

* Age \< 18 years
Interest of Nitazoxanide Treatment of Enterocytozoon Bieneusi Intestinal Microsporidiosis

Microsporidia are pathogenic fungi mainly responsible for profuse watery diarrhea, requiring management in immunocompromised patients. The main immunocompromised population affected by these infections consists of solid organ transplant recipients (SOT), mainly kidney (\~70% of cases in immunocompromised patients). In this population, the infection is severe, and becomes chronic in the absence of appropriate care, the species Enterocytozoon bieneusi being found in more than 95% of these cases. Reducing immunosuppression (adjustment of immunosuppressive therapy) can sometimes be enough to eliminate the pathogen. However, in some cases, specific treatment is necessary. The only molecule whose efficacy has been proven to date to treat infections caused by E. bieneusi is fumagillin (FLISINT®), however its production has been stopped for almost 2 years. Due to the therapeutic impasse, the use of nitazoxanide (ALINIA®) to treat E. bieneusi microsporidiosis is becoming common, despite the lack of proof of its efficacy. It seems important and urgent to evaluate the relevance of the use of nitazoxanide, particularly in SOT, for the treatment of intestinal microsporidiosis due to E. bieneusi.


Eligibility Criteria:
Inclusion Criteria:

* With a diagnosis of intestinal infection caused by E. bieneusi between 01/01/2018 and 03/31/2022
* having received treatment with nitazoxanide ("NITAZO" group), or fumagillin ("FUMA" group), or albendazole ("ABZ") or having received no specific treatment but having benefited from an adjustment of the doses of immunosuppressants ("IS" group)

Exclusion Criteria:

* With a diagnosis of extraintestinal infection
* With a diagnosis of infection by a species other than E. bieneusi
Safety and Pharmacokinetic Study of a Recombinant Coagulation Factor IX Albumin Fusion Protein in Subjects With Hemophilia B

The primary objective of the study is to assess the safety of IV administration of rIX-FP. Safety will be evaluated by adverse events and laboratory changes over time. The secondary objective of the study is to evaluate the pharmacokinetics parameters, following a single intravenous dose of rIX-FP.

This study is comprised of both a rIX-FP dose-escalation safety segment (25, 50 and 75 IU/kg of rIX-FP), and PK evaluation of rIX-FP after a single dose of 50 IU/kg, as well as PK evaluation after a single dose of 50 IU/kg of the previously given Factor IX (FIX) product (recombinant FIX \[rFIX\] or plasma derived FIX \[pdFIX\]) which is used as the reference product.

Eligibility Criteria:
Inclusion Criteria:

* Male, 12 - 65 years, with body weight ≥ 30 kg and ≤ 120 kg
* Documented severe Hemophilia B (FIX activity of ≤ 2%) or tested by the central laboratory at screening
* Subjects who have received FIX products for \> 150 exposure days (EDs) (estimated)
* No confirmed prior history of FIX inhibitor (history of positive FIX inhibitor defined as two consecutive positive tests - a confirmatory test on a second, separately drawn sample shortly after the previous positive test) and confirmed no detectable FIX inhibitors (negative FIX inhibitor defined as \< 0.6 Bethesda Units \[BU\] by the central laboratory at screening
* Subjects can be treated on-demand or under prophylactic therapy
* Signed Informed Consent/Assent

Exclusion Criteria:

* Known hypersensitivity (allergic reaction or anaphylaxis) to any FIX product or hamster protein
* Any known congenital or acquired coagulation disorder other than congenital FIX deficiency
* Platelet count \< 100,000/µL
* Immunocompromised (CD4 count \< 200/mm3), (HIV positive subjects may participate in the study and protease inhibitors and antiviral therapy are permitted, at the discretion of the Investigator)
* Currently receiving IV immunomodulating agents such as immunoglobulin or chronic systemic corticosteroid treatment
* Serum aspartate aminotransferase (AST) or serum alanine aminotransferase (ALT) concentration \> 5 times (x) the upper limit of normal (ULN)
* Serum creatinine \> 2 x ULN
* Evidence of thrombosis, including deep vein thrombosis, stroke, pulmonary embolism, myocardial infarction and arterial embolus within 3 months prior to enrollment
* Use of an Investigational Medicinal Product (IMP) within 30 days prior to the first rIX-FP administration
* Experienced life-threatening bleeding episode or had major surgery or an orthopedic surgical procedure during the 3 months prior to study entry
* Subject currently on a dose and/or regimen of FIX that would preclude participation in the study due to possible increased risk of bleeding because of the requirement to withhold treatment during the PK sampling period
* Suspected inability (e.g., language problem or mental condition) or unwillingness to comply with study procedures or history of noncompliance
A Randomized Trial of Rosuvastatin in Elective Angioplasty to Prevent Contrast-induced Nephropathy (CLEAR-CIN).

The investigators analyzed the HMG-CoA reductase inhibitor, rosuvastatin, for the prevention of contrast-medium-induced nephropathy in patients undergoing primary angioplasty.

Patients with stable coronary artery disease already taking chronic statin undergoing elective angioplasty are at risk for contrast-medium-induced nephropathy because there are specified risk factors as age more than 75 years, chronic renal insufficiency, diabetes, use of contrast and the lack of effective prophylaxis.

Eligibility Criteria:
Inclusion Criteria:

* chronic statin use
* positive stress test findings (electrocardiography, nuclear imaging, or stress echocardiography
* elective angioplasty.

Exclusion Criteria:

* non-statin therapy
* any presentation of ACS within 24 hours before the time of randomization
* current use of potent CYP3A4 inhibitors, including azole antifungals, protease inhibitors, macrolide antibiotics, and cyclosporine
* renal replacement therapy, a history of kidney transplant, pregnant and with renal failure (serum creatinine \> 3.0 mg/dl).
Safety and Efficacy of Long-term Daily Use of Mirapex®-LA Tablets in Patients With Parkinson's Disease

Post-marketing surveillance (PMS) to investigate the safety and efficacy of long-term daily use of Mirapex®-LA Tablets in patients with Parkinson's disease.


Eligibility Criteria:
Inclusion criteria:

- Patients with Parkinson's disease who have never been treated with Mirapex LA Tablets before enrolment will be included.

Exclusion criteria:

- None