cyrilzakka/clinical-trials huggingface dataset:
Cytomegalovirus-Specific Response Measured by QuantiFeron® and Overall Immunologic Response Measured by ImmuKnow® in Lung Transplant Patients CMV-positive

The purpose of this study is to determine the sensitivity and specificity of QuantiFeron® and ImmuKnow® in combination for early detection of patients who will develop CMV infection in lung transplant patients with CMV-positive serology (R+) prior to transplant.

The secondary objectives of the study are:

* To evaluate Cytomegalovirus (CMV)-specific immune response measured by QuantiFeron®.
* To evaluate overall immune response measured by ImmuKnow®.
* To study the course of QuantiFeron® and ImmuKnow®over the follow-up period.
* To correlate levels of ImmuKnow® and QuantiFeron®.
* To evaluate the relationship between levels and doses of immunosuppressants and their relationship to degree of overall immunosuppression (ImmuKnow®).
* To evaluate the relationship between infections, immunological complications and degree of overall immunosuppression (ImmuKnow®).

Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥ 18 years.
* Men or women who have received a lung transplant.
* CMV-seropositive patients (R+).
* Patients who have been informed of the study procedures and have signed the informed consent form.
* Over 3 months posttransplant.

Exclusion Criteria:

* Patients who are not expected to be able to be followed during the first 12 months posttransplant.
* Patient participation in another clinical trial or study will not be a criterion for exclusion.
Comparison of Excision Versus Punch Incision in the Treatment of Epidermal Cysts

The purpose of this trial is to compare two standard of care treatments for removing epidermal cysts. Surgical excision removes the entire cyst but requires a larger hole in the skin. A punch incision makes a smaller hole through which the cyst can be removed. The trial's purpose is to determine if one method is better than another in terms of recurrence, infection, or other side effects.

The purpose of this trial is to compare two standard of care treatments for removing epidermal cysts. Surgical excision removes the entire cyst but requires a larger hole in the skin. A punch incision makes a smaller hole through which the cyst can be removed. The trial's purpose is to determine if one method is better than another in terms of recurrence, infection, or other side effects.

Patients with epidermal cysts will be randomized to having the cyst removed by surgical excision or by a smaller punch incision followed by removal of the cyst through the smaller hole. The skin will be stitched shut in both cases. A short survey about how the cyst affects the patient will be given before the cyst is removed. When the stitches are removed 2 weeks later, photographs will be taken and a survey regarding satisfaction with the procedure will be given. Two additional phone surveys, given at 4 and 12 months after the procedure, wil be given to ask about recurrence, satisfaction with the procedure, side effects, and how the cyst affected the patient's life. The study doctor will be blinded as to which procedure each subject underwent. Forty subjects will be recruited at the Atlanta Veteran's Administration Medical Center

Eligibility Criteria:
Inclusion Criteria:

* Adult 18 years or older
* Epidermal cyst 1-3 cm in diameter on the trunk

Exclusion Criteria:

* Infected cyst requiring systemic antibiotics
* Pregnant females
* Unable to return to clinic for suture removal
* Previous excision of target cyst
A Study of PRT-201 Administered Immediately After Radiocephalic Arteriovenous Fistula(AVF) Creation in Patients With Chronic Kidney Disease (CKD) (PATENCY-1)

This research study is designed to assess the safety and effectiveness of an experimental drug called PRT-201 in patients both receiving or expecting to receive dialysis who have chronic kidney disease and who are undergoing surgery to create a new access point to their bloodstream for hemodialysis. PRT-201 is a protein that has been shown in previous research studies to help keep vessels patent when applied to the outside surface of the blood vessels (arteries and veins) in patients who undergo surgery to create an arteriovenous fistula (AVF). The purpose of this study is to determine whether PRT-201 when applied to a limited segment of your blood vessel (about 2 inches) immediately after surgery is safe and improves the patency of your AVF.


Eligibility Criteria:
Inclusion Criteria:

1. Age of at least 18 years.
2. Life expectancy of at least 6 months.
3. Diagnosis of Chronic Kidney Disease (CKD).
4. Planned creation of a new radiocephalic arteriovenous fistula (AVF)-revision of an existing AVF is not eligible.
5. Ability to understand and comply with the requirements of the entire study and to communicate with the study team.
6. Written informed consent using a document that has been approved by the Institutional Review Board (IRB).
7. If female and of childbearing potential (premenopausal and not surgically sterile) must have a negative serum pregnancy test at the screening visit (Visit 1) and be willing to use contraception from the time of the screening visit to 2 weeks following study drug administration. Acceptable methods of birth control include abstinence, barrier methods, hormones, or intra uterine device.

Exclusion Criteria:

1. Malignancy or treatment for malignancy within the previous 12 months with the exception of the following cancers if they have been resected: localized basal cell or squamous cell skin cancer, or any cancer in situ.
2. Presence of any significant medical condition that might significantly confound the collection of safety and efficacy data in this study.
3. Previous treatment with PRT 201.
4. Treatment with any investigational drug within the previous 30 days or investigational antibody therapy within the previous 90 days prior to signing informed consent.
Gastrointestinal Transit Time in Patients With Severe Acquired Brain Injury

Empirically patients with acquired brain injury (ABI) are often constipated. This is a major clinical issue. Nevertheless, this has only been sparsely studied.

The investigators will measure gastrointestinal transit time (GITT) in 30 patients with ABI, and compare this to healthy controls. Secondly heart rate variability (HRV) is measured in these patients, and associations between HRV and GITT are investigated.


Eligibility Criteria:
Inclusion Criteria:

* ABI:
* Moderate to severe traumatic brain injury (TBI) (Glasgow Coma Scale (GCS) score 3-12 at admission)
* or Stroke
* or Anoxic brain injury
* Ability to swallow the capsules used to assess GITT
* Ability to give meaningful informed consent to participate in the study

Exclusion Criteria:

* Major abdominal disorders
* Severe acute comorbidity
* Known cancer
* Pregnancy
* Known autonomic neuropathy
* Other known neurological disorder
Comparing Two Diets in Patients Undergoing HSCT or Remission Induction Chemo for Acute Leukemia and MDS (UF-BMT-LDND-101)

This is an open-label, two-arm, phase III non-inferiority trial to evaluate the safety of a liberalized hospital diet inclusive of fresh fruits and vegetables to a neutropenic diet in patients with prolonged neutropenia. Both cohorts and diets will adhere to the hygiene and common sense advice listed in the FDA-endorsed food safety guidelines.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Undergoing treatment for hematologic malignancies or HSCT as outlined below:
* Underlying diagnosis for non-HSCT patients:
* Acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) receiving induction or reinduction chemotherapy; OR
* Acute lymphoblastic leukemia (ALL) receiving an intensive induction chemotherapy (e.g., HyperCVAD±R, CALGB9251, Larsons protocol) with an expected duration of neutropenia of ≥7 days; OR
* Allogeneic or autologous HSCT for any indication. For patients undergoing reduced intensity conditioning, only those regimens in which the expected neutropenia is ≥ 7 days are permitted and the patient must reside in the hospital
* Expected duration of neutropenia of ≥ 7 days

Exclusion Criteria:

* Use of anti infectives for treatment of active systemic infections within 7 days prior to initiation of study diet
* Untreated major infection at presentation
* Patients with uncontrolled invasive fungal infection (defined as those who have not completed at least 6 weeks of treatment; or who are symptomatic with two CT scans, at least 1 week apart showing uncontrolled disease at the time of initiation of study diet)
* Uncontrolled HIV, Hepatitis B and C infection
* Receipt of nutrition via enteral tube or total parenteral nutrition at the time of enrollment
* Patients unwilling to eat fresh fruit and/or vegetables
* Planned management of neutropenia in the outpatient setting
Efficacy and Safety of IVIG-L in ITP Patients

The efficacy and safety of a liquid intravenous immunoglobulin product, IVIG-L, in patients with ITP will be assessed and compared with data obtained from literature.

Sanquin has developed, in cooperation with the Finnish Red Cross Blood Transfusion Service (FRCBTS), a liquid intravenous immunoglobulin product, IVIG-L. The liquid formulation of intravenous immunoglobulin simplifies infusion, eliminates possible mistakes in the reconstitution with water for injection and reduces space requirements in storage.

In addition to donor selection and screening, several procedures have been included in the production process to improve viral safety.

In this clinical trial, the efficacy and safety of IVIG-L in patients with ITP will be assessed and compared with data obtained from literature. IVIG-L will also be studied in patients with hypogammaglobulinemia.The results from both studies will be used for an application for marketing authorisation of IVIG-L in Finland and the Netherlands.

Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic ITP with a platelet count of about 20x109/L and at high risk of bleeding
* Patients with chronic ITP with a platelet count of about 20x109/L, who have to undergo surgery
* A stable clinical situation (no activity of any other disease)
* Age at least 18 yrs
* The patient/legally acceptable representative has signed the consent form

Exclusion Criteria:

* The presence of another autoimmune disease related with thrombocytopenia such as systematic lupus erythematosus (SLE), rheumatoid arthritis (RA) or nephritis
* Patients with drug-induced thrombocytopenia or immunologic thrombocytopenia of infectious origin (in particular, Hepatitis, Epstein-Barr virus, Toxoplasma, HIV)
* Massive splenomegaly
* Treatment with any other investigational drug within 7 days before study entry or previous enrolment in this study
* Having an ongoing progressive terminal disease, including HIV infection
* Known with allergic reactions against human plasma, plasma products or intravenous immunoglobulin
* Presence of conditions predisposing for bleeding: anaemia (hemoglobin \< 5.5 mmol/L), renal or urogenital disease, malignant disease (with the exception of basalioma, cervix carcinoma in situ), history of intracranial or aortic aneurysm, stroke, oeso-gastro-intestinal disorders with a bleeding potential, severe hypertension (diastole \> 110 mm Hg).
* Use of corticosteroids for an acute situation within 7 days before study entry. Patients using corticosteroids prophylactically can be included
* Splenectomy in the previous two weeks
* Renal insufficiency (plasma creatinine \> 115µmol/L)
* Pregnancy or lactation
* Known with insufficiency of coronary or cerebral circulation
* IgA deficiency and anti-IgA antibodies
A Study to Examine the Effect of Daridorexant on the Way the Body Absorbs, Distributes, and Gets Rid of Midazolam and Warfarin in Healthy Male Subjects

A study to examine the effect of daridorexant on the way the body absorbs, distributes, and gets rid of midazolam and warfarin in healthy male subjects


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent in a language understandable to the subject prior to any study-mandated procedure.
* Healthy male subject aged between 18 and 45 years (inclusive) at Screening.

Exclusion Criteria:

* Known hypersensitivity to daridorexant, midazolam, warfarin, or treatments of the same class, or any of their excipients.
* Any history of hemorrhagic disease, whether or not hereditary.
* Any history of complications with bleeding after surgery or tooth extractions and/or frequent nasal, hemorrhoidal, or gingival bleeding.
* Activated partial thromboplastin time (aPTT) \> 40 sec and/or international normalized ratio (INR) \> 1.15 at Screening.
* Platelet count \< 150 or \>400 x 10\^9/L at Screening.
* Clinically relevant findings on the physical examination at Screening.
* Clinically relevant abnormalities on 12-lead ECG, measured after 5 min in the supine position at Screening.
* Clinically relevant findings in clinical laboratory tests (hematology, coagulation, clinical chemistry) at Screening.
Effect of Oral Appliance Therapy on Glucose Levels in Patients With T2DM and OSA: A Pilot Trial

This study will evaluate the impact on blood glucose of the use of an oral appliance to treat obstructive sleep apnea (OSA) in individuals with Type 2 diabetes. An oral appliance is similar to a sports mouth guard or an orthodontic retainer and is an alternative treatment to continuous positive airway pressure (CPAP) for OSA. Oral appliance therapy has not been evaluated in patients with Type 2 diabetes with respect to glycemic outcomes. This will be a 1:1 randomized controlled trial: The experimental group will receive the oral appliance and the control group will receive a sham device over the course of approximately 5 months.

OSA is quite common in individuals with T2DM, occurring in as many as 60-80% of patients. The standard treatment for OSA is with the use of a CPAP machine. The CPAP provides an air pressure to keep the airways opened during sleep so that a person with OSA can breathe normally. When used appropriately, the CPAP improves sleepiness and quality of life. However, about half of the patients who receive a CPAP prescription cannot tolerate it and thus remain untreated and are potentially at increased cardiovascular and diabetes risk. In light of this, this study aims to see if the use of an alternative treatment for OSA, oral appliance therapy, where adherence is generally superior to CPAP, will improve cardiometabolic outcomes in individuals with Type 2 diabetes. This pilot trial will primarily examine feasibility and assess recruitment rates.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of T2DM using current Canadian guidelines
* OSA with AHI \> 10 events/hour using current American Academy of Sleep Medicine (AASM) criteria for scoring respiratory events

Exclusion Criteria:

* On treatment for OSA within the past 3 months
* Professional drivers or patients with an increased risk of driving-related accidents from clinical interview or severe subjective sleepiness (Epworth sleepiness scale greater than 15)
* Sleep apnea with any of the following features: highly severe OSA (AHI\>50 and oxygen desaturation index \> 50), severe hypoxemia (SpO2\<80% for \>10% of recording time), central sleep apnea or Cheyne-Stokes respirations with a central apnea index \>10 events/hour
* Coexisting sleep disorder other than OSA
* Active cardiovascular disease, including angina, arrhythmia or congestive heart failure
* Insufficient dentition or significant periodontal disease or other contraindication for OAT as determined by dentist qualified in OSA treatment
* Active and significant psychiatric disease
* BMI\>35
* Regular use of sedatives or narcotics
A Combined Tdap Vaccine Used As A Booster Compared To Licensed Td Vaccine

This study will evaluate the safety and immune response to GlaxoSmithKline Tdap vaccine compared to licensed Td vaccine when used as a booster in healthy adolescents (10-18 years of age).

A combined Tdap (Tetanus, Diphteria, Acellular Pertussis) Vaccine Used as a Booster compared to Licensed Td (Tetanus and Diphteria) vaccine

Eligibility Criteria:
Inclusion Criteria:

* Healthy adolescents with history of completed routine vaccination against diphtheria, tetanus, and pertussis (DTP).

Exclusion Criteria:

* Use of any other investigational drug or vaccine 30 days preceding study vaccination.
* Chronic administration of immunosuppressants.
* Administration of pre-school DTP vaccine within previous 5 years.
* Administration of Td booster within previous 10 years.
Identification of Hypoxic Brain Tissues by F-MISO PET in Acute Ischemic Stroke

This study is a French multicenter prospective study including 5 stroke units with available MRI and F-MISO PET for patients with acute ischemic stroke.

Background and Purpose: 18F-Fluoromisonidazole (FMISO) PET has been used to identify hypoxic tissues in animals and stroke patients. While MRI has become the gold standard acute stroke imaging, no published study has compared FMISO PET and MRI.

The aim of this prospective study is to identify hypoxic tissues in 40 patients with acute ischemic stroke with F-MISO PET and to compare the location and the outcome of these hypoxic cells with MRI datas (weighted diffusion and FLAIR) and to clinical outcome.

40 prospective patients (aged 18 to 85 years) will be included in the first 36 hours after ischemic stroke onset.

The study period will be 2 years. Included patients will have F-MISO PET followed by brain MRI (MRI-1)(diffusion, FLAIR, perfusion, TOF) as soon as possible after stroke onset (less than 36 hours). A second brain MRI (MRI-2) will be performed on day 7.

The aim of the study is to locate hypoxic tissues and to compare with ischemic tissues defined by diffusion and FLAIR MRI sequences, with MRI evolution, and with clinical status at day 7 and day 90.

Inclusion criterias

* Patients aged 18-85 years with encephalic brain ischemic stroke,
* defined stroke onset,
* NIHSS 5 to 20,
* F-MISO Pet and MRI available \<36 hours after stroke onset,

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-85 years with encephalic brain ischemic stroke,
* defined stroke onset,
* NIHSS 5 to 20,
* F-MISO Pet and MRI available \<36 hours after stroke onset,
* Written consent signed by patient or family

Exclusion Criteria:

* contraindication to MRI
* comatous status
* 5 \< NIHSS \> 20
* non ischemic stroke
* brainstem stroke
Contezolid Acefosamil Versus Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infection

The purpose of this study is to determine whether contezolid acefosamil is as safe and effective as linezolid in the treatment of adult patients with acute bacterial skin and skin structure infections


Eligibility Criteria:
Inclusion Criteria:

* Patients with systemic signs of infection diagnosed with acute bacterial skin and skin structure infection (ABSSSI)
* Diagnosed with cellulitis/erysipelas, major cutaneous abscess, or wound infections

Exclusion Criteria:

* Uncomplicated skin infections
* Severe sepsis or septic shock
* ABSSSI solely due to Gram-negative pathogens
* Prior systemic antibiotics within 96 hours of randomization
The Effect of tDCS on Subcortical Brain Functioning

This research is being done to determine whether transcranial direct current stimulation (tDCS) can improve certain abilities related to cognition, emotion and/or physical functioning in individuals with subcortical brain damage.

While cortical brain structures are thought to be responsible for higher level cognitive functioning (i.e., perception, thoughts, language, memory, attention, and processing), subcortical brain regions (i.e., amygdala, midbrain, hippocampus, and thalamus) are generally believed to be responsible for more fundamental bases of such functions. A significant fraction of the population suffer from disabling disorders and diseases (i.e., Parkinson's disease, subcortical dementia, hypoxic brain damage) that affect subcortical areas. Despite their prevalence, very little success has been achieved in treating such impairments effectively.

This study has two main goals. One is to examine the effect of stimulation on a variety of subcortical functions (i.e., level of alertness, mood, cognition, and motor responding). A second goal is to examine the effects of varying some of the stimulus parameters of tDCS, notably the placement of the electrodes and the duration and frequency of application of current.

Adult participants with a confirmed diagnosis of subcortical brain damage, as well as healthy adults will be randomly assigned to anodal and cathodal stimulation in a counterbalanced order, and both will engage in simple behavioral tasks and/or physiological monitoring. These tasks will be specific to the deficit of interest.

Eligibility Criteria:
Inclusion Criteria:

* Fluent in the English language
* History of subcortical brain damage (patient group only)
* No known neurological or cognitive impairment (control group only)

Exclusion Criteria:

* Appreciable deficits in hearing
* Schizophrenia, bipolar disorder, or major depression (normal controls only)
* Any neurological disorder associated with cognitive impairment or neuroanatomic abnormality (normal controls only)
* Language-based learning disorder (normal controls only)
* Dementia or Mini-Mental State Exam \<24 for normal control participants
* Any implanted metal device (precludes use of tDCS)
* Any implanted cardiac pacemaker
Treatment of Functional Abdominal Distension by Non-instrumental Biofeedback

Background. Abdominal distention is produced by an abnormal somatic postural tone. The authors developed an original biofeedback technique based on electromyography-guided control of abdominothoracic muscular activity. In a randomized, placebo-controlled trial the authors demonstrated the superiority of biofeedback over placebo for the treatment of abdominal distention. However, the technique is technically complex and unpractical.

Aim. To prove the efficacy of a non-instrumental biofeedback technique for the treatment of abdominal distension.

Selection criteria. Visible abdominal distension after meal ingestion; patients are able to identify the offending meal.

Intervention. Patients will be randomized into biofeedback in placebo groups. Three sessions of either biofeedback or placebo intervention will be performed during the first 3 weeks of the intervention period.

Biofeedback: patients will be taught to control abdominal and thoracic muscular activity by providing instructions using an original video support. Patients will be instructed to perform the same exercises before and after breakfast, lunch and dinner during the 4-week intervention period.

Placebo: sham measurements of abdominal and thoracic motion will be performed, and a pill of placebo containing 0.21 g glucose will be administered; patients will be instructed to take a pill of placebo before breakfast, lunch and dinner during the 4-week intervention period.


Eligibility Criteria:
Inclusion Criteria:

* episodes of visible abdominal distension triggered by meal ingestion
* patients are able to identify the offending foodstuff

Exclusion Criteria:

* organic cause detected by clinical work-up
* constipation
* abdominal distension not confirmed by the 7-day clinical questionnaires or after the probe meal in the pre-intervention evaluation