cyrilzakka/clinical-trials huggingface dataset:
Neuropsychological Impact of Hospitalization on Intubated, Ventilated and Sedated ICU Patients

This is a prospective, single-center, pilot, cohort study. The first phase of this study is observational and the usual care of patients is maintained during the ICU stay, except for an interview with a psychologist preceding patient discharge. A phone interview at 2 months and a visit with a psychologist at four months after ICU discharge are specific to the study.

The main objective of this study is to make a first estimate of the percentage of patients (CI = +- 10%) with cognitive impairment at four months after ICU discharge. The presence / absence of cognitive impairment will be determined by the D2 test.

The secondary objectives of this study are:

A. To study the potential links between cognitive impairment and quality of life 4 months after discharge from the Intensive Care Unit.

B. To study the associations between variables measured during hospitalization. Is there "clustering" among certain symptoms during hospitalization?

C. To study the associations between variables measured at two and four months after ICU discharge. Is there clustering among these symptoms?

D. To study potential risk factors for cognitive problems at 4 months after ICU discharge.

E. If objective C determines the presence of clusters, is the presence / absence of these clusters related to the variables (or clusters of variables) measured during hospitalization?

F. To study potential risk factors for poor quality of life at 4 months:

Eligibility Criteria:
Inclusion Criteria:

* The patient (or his/her "trusted person") must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient is available for a telephone interview at 2 months after ICU discharge, and for a follow-up visit at 4 months after ICU discharge
* Patient admitted to the ICU and intubated and ventilated for at least 48 hours

Exclusion Criteria:

* The patient is currently participating in or has participated in another study (within the past 3 months) that might influence the results of the current study
* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* The patient is pregnant, parturient, or breastfeeding
* The patient has a contra-indication for a treatment used in this study
* Patient admitted to intensive care with sedation started for more than 24 hours
* Patient with neurological or psychiatric (cognitive) disorders
* Patient admitted for cardiac arrest
* Patient admitted for stroke
* Patient admitted for cervical trauma \> C6
* Patient presenting with tracheotomy accompanied by long-term mechanical ventilation
* Moribund patient or with little hope of survival beyond 48 hours
* Patients for whom a limitation or termination of care is considered
* McCabe Score = 0
* Knauss Scale = C or D
Health Facility Networking for Maternal Health

This study will introduce a multi-faceted intervention package which will be implemented in the newly developed network of St. Paul's Hospital Millennium Medical College (St. Paul) and the surrounding seven satellite health centers. The goal is to assess if this group of interventions improve the skills and confidence of providers to handle obstetric emergencies, if they streamline the referral process and if they result in improved maternal/newborn health outcomes.


Eligibility Criteria:
Inclusion Criteria:

Sample population for each data collection instrument:

Baseline/Endline:

Key Informant Interviews:

* St. Paul hospital: Maternal Child Health (MCH) Head, Midwife/nurse from Labor and Delivery (L\&D), Midwife/nurse from Emergency
* Health Centers: Medical Director, Head of MCH (midwife) Midwife from L\&D, Referral focal person

Health Facility Assessment:

- Manager/most senior health worker asked (one from each facility)

Provider Survey:

- All providers in the MCH at both the hospital and health center level

Chart review:

- All deliveries in all centers will be screened during the intervention phase. Data on every birth will be collected from the log books of each facility. The data collector will then find the medical record of that patient to assess the Standard of Care (SOC) during Ante-natal care (ANC)- if available from the chart, L\&D and screen for an obstetric complication. If there was a complication, the near miss data will be collected.

Telephone registration log book:

- all phone calls between HC and Hospital

Facility Checklists:

- Forms completed by Supportive Supervision Teams at quarterly visits

Standardized BEmONC training evaluation

- Will be given to every provider undergoing the training, as part of the training curriculum.

Monthly mentoring evaluations - for the six months post-training mentorship, for all providers who have undergone BEmONC training.

Supportive Supervision Gap Identification Checklists

- Collected quarterly from each of the 9 facilities
A Sleep-Oriented Intervention for Suicidal Behaviors

An open-label trial to investigate the use of a behavioral insomnia treatment for suicidal ideation.


Eligibility Criteria:
* Age 18 or older
* Clinically significant sleep disturbances
* Diagnosis of depression
Study to Assess the Safety and Tolerability of AZD1152 in Combination With Low Dose Cytosine Arabinoside (LDAC)

A study to assess the safety and tolerability of AZD1152 in combination with low dose cytosine arabinoside (LDAC) in patients with acute myeloid leukaemia (AML). The first three patients to complete a 28 day cycle in the cohort, before the second three patients start treatment.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed patient.
* Provision of written informed consent.
* De Novo (primary) or Secondary AML.
* Not eligible for intensive induction chemotherapy because of medical, social or psychological reasons.

Exclusion Criteria:

* Patients with AML of FAB M3 classification Acute Promyelocytic Leukaemia (APL).
* Patients with blast crisis of chronic myeloid leukaemia.
* Persistent, chronic, clinically significant toxicities from any prior anti- cancer therapy greater than CTCAE Grade 1 (except alopecia).
Low Level Laser Therapy in the Treatment of Temporomandibular Joint Disorders (TMJDs) Related Pain

The Low Level Laser Therapy (LLLT) has been recently introduced with success in the management of the pain associated to this condition. This double blind placebo controlled clinical trial analyzes a new home LLLT protocol to verify whether it was possible to avoid to the repeated presence at dental chair required by traditional LLLT protocols.

90 patients with pain deriving from mono- or bi-lateral TMJDs were enrolled in the study. Randomly subdivided in 3 groups. The Study Group (SG n=30) receive a LLLT by the B-cure Dental Pro 808nm diode low level laser (Biocare Enterprise Ltd, Good Energies, Haifa, IL). The therapeutic protocol previews 2 applications a day for 7 consecutive days performed at 5 Joules/min, 250 milliWatts and 15 KiloHertz for 8', (40 Joules total each) in contact mode over the painful area.

The first application is performed at the Department of Oral Sciences of Sapienza University of Rome, by a laser expert blinded examiner and serves as instruction. The remnants applications must be performed at home by the patients themselves.

The Placebo Group (PG n=30) follows the same protocol by a sham device, seemingly identical to the effective ones, including the pointer light, but devoid of the main diode source.

The Drug Control Group (DG n=30) follows the conventional drug treatment for TMJDs related pain, 2 non-consecutive cycles of 5 days of nimesulide (100mg a day), interspersed with one 5 days cycle of cyclobenzaprine hydrochloride (10 mg a day) Two pain evaluation are registered, before and after treatment.

Eligibility Criteria:
Inclusion Criteria:

* TMJD diagnosed clinically and by CT and MRI; presence of pain in the TMJ area or radiating to the face, jaw, or neck; reduced mouth opening or jaw locks, painful clicking, popping or grating when opening or closing mouth, occlusal alterations

Exclusion Criteria:

* Muscle tenderness; NSAIDs assumption within 3 weeks before the treatment; pregnancy; neurocognitive diseases; autoimmune diseases; connective diseases
Allied Cleft & Craniofacial Quality-Improvement and Research Network (ACCQUIREnet)

The Allied Cleft \& Craniofacial Quality-Improvement and Research Network (ACCQUIREnet) is a group of multidisciplinary cleft teams that have implemented a system for prospective collection of outcomes data, based on the ICHOM Standard Set for the Comprehensive Appraisal of Cleft Care, CLEFT-Q, and other outcomes instruments. Participating cleft teams may analyze clinical and psychosocial outcomes related to care of the child with cleft lip and/or palate (CL/P), compare its performance with those of other cleft centers, and identify opportunities for quality improvement.

The purpose of this project is to implement a system of prospective, standardized data collection for all patients with cleft lip and/or palate (CL/P) treated by the cleft and craniofacial centers that participate in ACCQUIREnet.

Adoption of this prospective data-collection system has two principal goals:

1. To enable on-demand and scheduled review of cleft-care-related safety and outcomes data and team performance for the purpose of internal audits and continuous quality improvement; and
2. To permit participation in multi-site, collaborative quality-improvement projects and/or research networks that require usage of these standardized data-collection methods. (These collaborations are described in corresponding IRB protocols and data-transfer agreements. Patient privacy and confidentiality is protected at all times.)

All patients with CL/P treated at cleft and craniofacial centers participating in ACCQUIREnet will be invited to participate in this project. Duke University serves as the coordinating center and statistical support center for the study. Data are maintained in a local, secured database.

The IRB protocol details methods of quality assurance, data monitoring, and auditing. Data dictionaries employed in ACCQUIREnet include the CleftCap REDCap project template, CleftKit Common Data Model (an extension of the PCORnet Common Data Model), the ICHOM Standard Set for the Comprehensive Appraisal of Cleft Care, and the CLEFT-Q patient-reported outcome manual, maintained by the International Consortium for Health Outcomes Measurement (ichom.org) and McMaster University, respectively.

Eligibility Criteria:
Inclusion Criteria:

* Typical orofacial clefts, of which subtypes are:
* Unilateral or bilateral cleft lip
* Unilateral or bilateral cleft lip and alveolus
* Unilateral or bilateral cleft lip and alveolus and palate
* Unilateral or bilateral cleft lip and palate
* Overt cleft palate
* Occult cleft palate

Exclusion Criteria:

* Atypical (Tessier) facial clefts
Human Immune Globulin in Treating Patients With Primary Amyloidosis That is Causing Heart Dysfunction

RATIONALE: Antibodies, such as human immune globulin, can block the growth of abnormal cells in different ways. Some block the ability of abnormal cells to grow and spread. Others find abnormal cells and help kill them or carry cell-killing substances to them. Giving human immune globulin may be effective in treating patients with primary amyloidosis that is causing heart dysfunction.

PURPOSE: This phase I/II trial is studying the side effects and best dose of human immune globulin and to see how well it works in treating patients with primary amyloidosis that is causing heart dysfunction.

OBJECTIVES:

* Establish the maximum tolerated dose of human immune globulin intravenous (IGIV) given weekly for the first 3 months and then bi-weekly for 9 additional months in patients with cardiac-associated primary light chain-associated (AL) amyloidosis.
* Determine the safety, pharmokinetics, and therapeutic efficacy as evidenced by titers of serum fibril-reactive immunoglobulin G (IgG) antibodies pre- and post-IGIV infusions.
* Demonstrate stable or improved organ function.

OUTLINE: Patients receive human immune globulin IV (IGIV) once weekly for 3 months and then once biweekly for 9 months, for a total of 12 months in the absence of disease progression or unacceptable toxicity.

Patients undergo blood sample collection to measure serum anti-fibril antibody titers pre- and post- IGIV infusion for assessing safety and response to treatment.

Eligibility Criteria:
Inclusion criteria:

* Confirmed diagnosis of cardiac-associated primary (AL) amyloidosis based on accepted clinical and laboratory criteria
* Patients must have heart involvement as evidenced by elevated serum brain natriuretic peptide (BNP), troponin levels, and/or 2D echocardiography evidence of a thickened intraventricular septum (IVS).
* Life expectancy \> 3 months
* Prior or concurrent chemotherapy or other drug-based anti-AL regimes allowed

Exclusion criteria:

* Non-AL amyloidosis
* New York Heart Association (NYH) class IV heart disease
* Significant comorbidity (e.g., uncontrolled infection, diabetes, or other serious illnesses)
Reflectometric Measurement of Retinal Oxygen Saturation in Patients With Chronic Obstructive Pulmonary Disease (COPD) Grade IV and Healthy Subjects

An adequate oxygenation and retinal perfusion is essential for the function of the inner retina. There is a wide range of autoregulation mechanisms to ensure a sufficient ocular blood and oxygen supply during changes in systemic blood pressure or intraocular pressure (IOP). Nonetheless, various retinopathies such as diabetic retinopathy, which is the leading cause of blindness in people aged 20-65 in the western world, are highly associated with hypoxia (Pemp and Schmetterer 2008). Hence, measurements of oxygen levels in retinal vessels are needed to further our understanding of these ischemic diseases. It is a well known fact and a commonly employed method to measure oxygen saturation of blood through light transmission (Kramer 1934). However, this approach is not feasible in the human eye. Therefore, reflection must be used, meaning the amount of incident light must be estimated based on the amount of light reflected (for a review see Harris 2003). This is a difficult task and investigators in this field have encountered several problems, including optical complexities, nonlinear sensors and eye movement (Beach et al 1999; Delori 1988). Nonetheless considerable progress has been made over the past decades and the development of an reliable oximeter reported (Hardarson et al 2006).

In the present study this technique will be applied in healthy subjects as well as in patients with COPD during room-air conditions. The procedure takes approximately 15 minutes in each subject and will be performed in only one eye.


Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria for healthy subjects:

* Men and women aged between 18 and 99 years
* Tiffeneau Index \> 70 %
* Body mass index between 15th and 85th percentile
* Normal ophthalmic findings, ametropia \< 3 Dpt.

Inclusion criteria for COPD patients:

* Men and women aged between 18 and 99 years
* COPD grade IV, oxygen dependent and with a forced expiratory volume in 1 second (FEV1) \< 30 %
* Body mass index between 15th and 85th percentile
* Normal ophthalmic findings, ametropia \< 3 Dpt.

Exclusion Criteria:

Healthy subjects:

* Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
* Treatment in the previous 3 weeks with any drug except oral contraceptives
* Symptoms of a clinically relevant illness in the 3 weeks before the study day
* Blood donation during the previous 3 weeks

COPD patients:

* Abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
* Health status which does interfere with study procedure or their safety
* Blood donation during the previous 3 weeks
* Symptoms of a clinically relevant illness other than COPD or COPD related in the 3 weeks before the study day
Pre-meal Protein Drink Improve Glycemic Regulation

The purpose of this study is to investigate if a pre-meal drink containing proteins can positively influence glycaemic control in patients with type 2 diabetes mellitus. Comparison with a placebo is included.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed type 2 diabetes mellitus according to WHO criteria (1999)
* age between 30-80 years
* non well controlled diabetes with HbA1c-levels above 62 mmol/mol

Exclusion Criteria:

* pregnant or risk of becoming pregnant
* severe disease
* psychological disease, dementia or mental disability that makes it impossible to retrieve informed consent of participation
* liver disease
* kidney malfunction (GFR \<60 or aspartate transaminase (ASAT)/alanine transaminase (ALT) two times higher than the normal interval
Study To Evaluate Beta Cell Function and Glycemic Outcome by Intensive Insulin Therapy

This randomized controlled prospective study aims to evaluate the efficacy of intensive insulin therapy for long term glycemic control and improvement or preservation of beta cell function in newly diagnosed type 2 diabetes patients.

Type 2 diabetes is associated with beta cell dysfunction and insulin action at diagnosis of diabetes. Although the relative importance of these two alterations is controversial, growing evidence is swinging to the concept that there is no hyperglycemia without β-cell dysfunction. Also there is agreement that deterioration of glucose tolerance over time is associated with a progressive decrease of beta cell function.

Beside the role of genetic factor, the continuous decline in β-cell function is affected by glucotoxicity generated by hyperglycemia and lipotoxicity due to high fatty acid. A vicious cycle of hyperglycemia per se further impairs and may destroy β-cell. Recently, many reports have shown that early intensive glycemic control plays a role in the prevention of progressive ß-cell function and worsening of diabetes.

Some studies have shown that early intensive insulin therapy(IIT) to achieve near normoglycemia in new onset type 2 diabetes gives short term and long term improvement in glycemic control after discontinuation of insulin. It is suggested that long term glycemic control is associated with improvement of β-cell function.

In the unpublished previous pilot study, the investigators found that early intensive insulin therapy using multiple daily injection (MDI) or daily twice injection in newly diagnosed type 2 diabetes can significantly improve the beta cell function and facilitate further long term glycemic control. To establish the effectiveness of intensive insulin therapy for long term glycemic control and improvement of β-cell function, the investigators will perform a randomized controlled prospective study in newly diagnosed type 2 diabetes in Korea.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed drug naïve type 2 diabetic patient with typical diabetic symptom (polydipsia, polyuria, unexplained weight loss) within recent 1 year
* Initial HbA1c : 8.0 % ≤ HbA1c \< 12.0%

Exclusion Criteria:

* Known contraindication to insulin glargine, insulin glulisine, metformin, glimepiride
* Patients with proliferative diabetic retinopathy
* Severe liver disease or AST, ALT ≥ 2.5 x ULN
* History of lactic acidosis
* Unstable or severe angina
* Congestive heart failure
* Chronic disease treated with continuous corticosteroid therapy
* Diagnosis of cancer
* Positive urine pregnancy test or plan to become pregnant during the clinical trial
Evaluation and Comparison of Systemic Exposure to Ibuprofen After Single Oromucosal Versus Oral Administrations

The purpose of this study is to evaluate the systemic exposure to ibuprofen after single oromucosal administration of the test product V0498 and single oral administration of a reference product.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subject aged 18 to 45 years (inclusive),
* 18.5 \< or = Body Mass Index \< or = 30 kg/m²,
* Non-smoker for at least 6 months
* Subject agreed to be registered in the Belgium national register "VIP Check International" for this study participation .

Exclusion Criteria:

* Positive serology for Hepatitis B Virus antigens, Hepatitis C Virus or Human Immunodeficiency Virus 1 or 2 antibodies,
* Organic disorder likely to modify absorption, distribution or elimination of the medication,
* History of sensitivity to ibuprofen or other NonSteroidal Anti-Inflammatory Drugs (NSAIDs) or to any of the excipients
* Subject who has donated blood within the past 3 months,
* Subject who has forfeited his freedom by administrative or legal award, or who is under guardianship or who has been admitted in a sanitary or social institution,
* Participation in another clinical trial in the previous month or subject still within the exclusion period of a previous clinical trial or is participating in another clinical trial,
Acral Cutaneous Thrombotic Vasculopathy and Covid-19 Infection

Spectrum of skin lesions may arise during Covid-19 virus infection. It includes non-specific urticaria, aphtoids lesions, but also acrosyndromes, in particular suggestive of chilblains. Pathological findings showed thrombocytic lymphocytic vasculitis. Chilblains are sometimes associated with Raynaud's phenomenon or acrocyanosis. Dermatological features may present pathophysiological similarities with the inflammatory and respiratory vascular disturbances, which makes all the gravity of this disease, or even with other organs. Indeed, genetic conditions such as familial lupus chilblains, linked to a mutation of TREX1 gene, and SAVI (Sting associated vasculopathy with onset on infancy) have similar clinical presentations. In particular, SAVI associates both acral skin and lung damage, and auto-antibodies. They have recently been identified as type I interferonopathies. Hallmark is interferon signature, i.e. hyperexpression of type I interferon in the blood.

The investigators hypothesize Covid-19 may lead to similar skin involvement as in type I interferonopathies. The interferon pathway is involved in anti-viral defense. Covid-19 could cause excessive activation of this pathway. In addition, hyperactivation of the type I interferon pathway leads to modulation of the adaptive immune response. Production of autoantibodies, in particular antiphospholipid antibodies, have thrombogenic properties. Searching for acquired hemostasis disorders and high level of interferon secondary Covid-19 virus infection, could explain this new and misunderstood skin disorder. Then, targeted therapies, both treating and preventing, could be considered.


Eligibility Criteria:
Inclusion criteria:

* Chilblains or vascular abnormalities (Raynaud's phenomenon, purpura, livedo, necrosis, acrocyanosis) of the acral skin (hands, feet, nose, ears) developping during or after a proved or suspected Covid-19 infection.

Exclusion criteria:

* None