cyrilzakka/clinical-trials huggingface dataset:
Light Therapy in End Stage Kidney Disease

The goal of this clinical trial is to test light therapy in patients with end stage kidney disease who are receiving hemodialysis. The main aim is to determine if light therapy decreases fatigue severity. Participants will receive light therapy using special glasses for one hour during the dialysis sessions for four weeks of treatment.

In a single site, 2-arm (Bright Light Therapy group; Dim Light Group), parallel, randomized controlled trial we will enroll 60 subjects (n=30 per group) to assess the effects of Bright Light Therapy compared to Dim Light Therapy in subjects with end stage kidney disease who are receiving hemodialysis to treat fatigue.

* To compare the effects of bright light therapy to dim light therapy on fatigue severity.
* To explore the effects of bright light therapy to dim light therapy on salivary cortisol.
* To compare the effects of bright light therapy to dim light therapy on insomnia, depression and quality of life.
* To test the effects on bright light therapy to dim light therapy on physical activity levels.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent prior to initiation of any study mandated procedure
2. Male and female participants ≥ 18 years of age
3. Diagnosis end stage kidney disease with hemodialysis 3 times/week for at least 1 month
4. Fatigue Severity Scale (FSS) \> 9 at enrollment
5. Home refrigerator for salivary cortisol storage

Exclusion Criteria

1. Eye disorders: cataracts, glaucoma, retinal disorders (e.g. macular degeneration)
2. Participants with photosensitivity (e.g. epilepsy)
3. Hospitalized or acutely ill
Investigation of New Intermittent Catheter Swelling Media in Healthy Volunteers

Investigation of novel swelling media for CE marked intermittent urinary catheters. The study was a randomized, single blinded, cross-over investigation comparing a novel swelling media with a comparator swelling media in 22 adult, healthy, male volunteers.

The CP279 study investigated a novel swelling media for male intermittent urinary catheters. The study was conducted in Denmark and was a single-site, randomized, single blinded, cross-over investigation, testing inferiority of a novel catheter swelling media against a comparator swelling media in 22 adult, healthy, male volunteers.

Each participant was randomized to one of two treatment arms, using a randomization sequence of two (i.e., with two different random options for the order in which the participants tested the two swelling media). The study thus contained two test visits, for which the 22 participants tested the two different swelling media, respectively. There was 4-14 days between the test visits and all catheterizations were performed by trained nurses. Due to a visual difference between the products, it was only possible to blind the subjects.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent given
* Minimum 18 years of age and with full legal capacity
* Male gender
* Willing to refrain from using analgesics up to 24 hours prior to catheterization visits
* Negative urine multistix analysis for erythrocytes (microscopic hematuria)
* Negative urine multistix analysis for leukocytes and nitrite, or if positive, subsequent negative for bacterial growth in urine culture

Exclusion Criteria:

* Abnormalities, diseases or surgical procedures performed in the lower urinary tract
* Symptoms of urinary tract infections (at least one of the following: frequent urination, stinging or pain at urination)
* Participating in other clinical investigations related to urinary tracts system during this investigation (inclusion to termination) or previously participation in this investigation
* Known hypersensitivity toward any of the investigational device
Feasibility of Remote Home Support Coaches (SOCIAL Study)

The goal of this this study is to develop and test the feasibility of a remotely delivered brief behavioral activation intervention to decrease the negative physical and psychological consequences of being homebound among older adults during the time of COVID.

The goal of this study is to develop and test the feasibility of a remotely delivered brief behavioral activation intervention to decrease the negative physical and psychological consequences of being homebound among older adults during the time of COVID.The intervention will focus on decreasing the impact of social isolation, inactivity and poor nutrition on old people during a time when many in-person social activities are not possible. It will be delivered through telephone and other communication tools that allow remote (i.e. not in person) communication over 10 sessions. Subjects will be a total of 60 people aged 75 years an older, who will be recruited from primary care in the Boston MA region and senior living facilities in the Baltimore MD region. Coaches will be trained using an on-line based modules developed to support this intervention. Self-report outcomes will be measured by telephone at baseline and 4-month follow-up.

Eligibility Criteria:
Inclusion Criteria:

* • Men or women who are 75 years or older

  * Must be a patient of Mass General Brigham affiliated with Primary Care Physician departments in Boston, MA OR be a resident of Brightview Senior Living and Assisted Living facilities near Baltimore, MD

Exclusion Criteria:

* • Men or women who are 74 years and younger

  * Participants who are not affiliated with Primary Care Physician departments at Mass General Brigham or a resident of an assisted living facility in Baltimore, MD
  * Unable to adequately complete the Evaluation to Provide Consent
A Study to Evaluate Pharmacokinetics of Sonazoid™ Following Intravenous Bolus Injection in Healthy Volunteers

The primary purpose of this study is to determine the Pharmacokinetics (PK) data of perfluorobutane (PFB) in blood and exhaled air following intravenous (I.V.) bolus injection of Sonazoid™ in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria: Participants may be included in the study if they meet all of the following criteria:

* Participant is between 18 and 45 years of age
* Participant is male, or a female who was either surgically sterile (has a documented bilateral oophorectomy and/or documented hysterectomy), postmenopausal (cessation of menses for more than 1 year), or non-lactating, or if of childbearing potential the results of a serum or urine human chorionic gonadotropin pregnancy test, performed on the day of Sonazoid™ administration (with the result known before IMP administration), were negative
* Participant is able and willing to comply with study procedures and provide signed and dated informed consent
* Participant has a body mass index of 19 to 26
* Participant has agreed not to smoke from 2 hours before to 5 hours after Sonazoid™ administration
* Participant has agreed to avoid strenuous physical activity from 1 week before Sonazoid™ administration until the end of the study follow-up
* Participant has no history of alcohol or substance abuse, and has agreed to no intake of alcohol or drugs for 48 hours before Sonazoid™ administration and until the end of the study follow-up
* Participant has a normal health status, as judged by medical history and physical examination at screening
* Normal 12-lead electrocardiogram (ECG) at screening. Minor abnormalities considered by the investigator to be of no clinical importance are permitted
* Normal blood and urine clinical chemistry variables at screening. Isolated or minimally out-of-range values considered by the investigator to be of no clinical importance are permitted
* No regular use of concomitant medication, except for routine use of supplemental oestrogen

Exclusion Criteria:

* Participant was previously included in this study
* Participation in another clinical trial with an unregistered medicinal product, or less than 30 days have passed since completing participation in such a trial
* Participant has a history of allergies to eggs or egg products (i.e., manifested by full body rash, respiratory difficulty, oral and laryngeal swelling, hypotension or shock)
* Donation of \>500 milliliter (mL) blood in the 12 weeks before Sonazoid™ administration
* Participant with congenital heart defects, including right-to-left, bi-directional, or transient right-to-left cardiac shunts
* Participant has positive test results for hepatitis B, hepatitis C, or human immunodeficiency virus
Bipolar Intervention Study: Cognitive Interpersonal Therapy

There is a need to develop a better understanding of the early phase of bipolar disorder, and to develop and evaluate effective psychosocial interventions that assist people in this phase. The purpose of this study is to determine whether or not it is feasible to conduct a larger study of the effectiveness of cognitive interpersonal therapy (a psychological therapy) with individuals who have experienced their first or second treated episode of mania or hypomania (symptoms common in early development of bipolar disorders).

The 'PICO' framework (Oxman, Sackett, and Guyatt, 1993; Richardson, Wilson, Nishikawa, and Hayward; 1995) was used to specify the parameters of the study aims and objectives:

1. Population: could appropriate individuals be identified and recruited to a trial of CIT for early bipolar disorder?
2. Intervention: would CIT be an acceptable intervention for individuals following a first or second treated episode of mania and or hypomania? Could we identify any modifications required to the CIT protocol used with this group?
3. Control group: could an appropriate group of participants be recruited to facilitate a comparison with the CIT intervention? Could we explicitly establish the usual care package and its local implementation?
4. Outcomes: which outcomes are appropriate for measuring relevant dimensions of a treatment effect?

Eligibility Criteria:
Inclusion Criteria:

* Eligible individuals will have experienced their first or second treated episode of mania and / or hypomania in the previous 12-months prior to study entry.

Exclusion Criteria:

* Participants will be excluded if there is a (1) diagnosis of learning disability; (2) inability to participate in psychotherapy/research due to acute medical condition or acute mania
Assessement of the Prevalence of Lysosomal Acid Lipase Deficiency in Liver Post-transplant Patients

Lysosomal Acid Lipase (LAL) deficiency is a rare, autosomal recessive storage disease linked to decrease enzymatic activity of LAL, responsible for intracellular accumulation of cholesterol esters and triglycerides.

The accumulation of lipid is in hepatocytes, Kupffer cells and macrophages leading to a fatty liver, hepatic fibrosis that can evolve up to cirrhosis.

LAL deficiency is responsible for significant morbidity and early mortality in children, adolescents and adults in connection with a multi visceral disease reaching the liver, gastrointestinal tract and the vascular endothelium. The disease is caused by homozygous or heterozygous mutations in the gene (LIPA chromosome 10q23.2-23.3) which is responsible for the synthesis of the LAL.

The disease can be diagnosed by enzymatic analysis using few drops of blood absorbed onto blotting paper.

Patients with this deficiency LAL, have no or reduced activity of this enzyme. Because of its rarity, the deficit in LAL is under diagnosed or is diagnosed in patients with liver biological disturbances and / or lipid profile disturbances, steatohepatitis-hepatitis (NASH), the steatosis (NAFLD), the cryptogenic cirrhosis or Wilson disease.

Inclusion period of 12 to 18 months (100 patients).


Eligibility Criteria:
Inclusion Criteria:

* liver post-transplant patient
* patients with cryptogenic cirrhosis, NASH

Exclusion Criteria:

* Patients without metabolic syndrome clinical, biological or radiological.
Exercise and Dry Needling Treatment Combination in Nocturnal Calf Cramps

The Investigators aim to evaluate the effectiveness of dry needling treatment in addition to stretching exercises on cramp duration, cramp intensity, cramp frequency, sleep quality, and sensitivity of myofascial trigger points in patients with nocturnal calf cramp.

Nocturnal leg cramps are sudden, involuntary, painful contractions of the lower extremity in the nighttime, most often in the calf muscles, that gradually lessens. Its etiology is not clear. It can be seen in electrolyte disturbances, drug side effects, neuromuscular diseases, diabetes mellitus, peripheral vascular pathologies. It has been mentioned in the literature that myofascial trigger points in the gastrocnemius muscle may be associated with nocturnal calf cramps. Our aim in this study is to evaluate the effectiveness of the combination of stretching exercises and dry needling therapy on cramp duration, cramp intensity, cramp frequency, sleep quality, and algometer measurement in patients with nocturnal calf cramps and whose had myofascial trigger point in the gastrocnemius muscle.

Eligibility Criteria:
Inclusion Criteria:

* Patients with only nocturnal calf cramp
* Patients with a trigger point in the unilateral gastrocnemius muscle
* Being between the ages of 18-50

Exclusion Criteria:

* Patients using diuretics or hypertension medications that may trigger cramping
* Those with a chronic disease history
* Those diagnosed with spinal stenosis
* Electrolyte disturbance in laboratory tests
Catastrophizing and Virtual Reality's Impact on Pain in Patients With Fibromyalgia

This study evaluates the potential association between Virtual Reality, pain catastrophizing thoughts and pain measures in fibromyalgia.


Eligibility Criteria:
Inclusion Criteria:

* Able to understand, read and speak Danish
* Able to independently answer a questionnaire
* Able to give informed consent

Fibromyalgia group:

* Confirmed diagnosed with fibromyalgia

Controls:

* Healthy participants

Exclusion Criteria:

Applies for both groups:

* Signs of anxiety, depression and post-traumatic stress syndrome that require treatment
* Neurologic, musculoskeletal or mental illnesses that could influence the results.
* Parallel participating in other studies, that can influence this study
* Pregnancy

Fibromyalgia group:

* Regulation in medication
* Anticonvulsivant use the last week
* Serotonin-norepinephrine reuptake Inhibitor (SNRI) the last two weeks
* Tricykliske antidepressants (TCA) the last four weeks

Controls:

* No regular use of pain medication
* No current or previous history of subacute or ongoing pain
PARAT PLUS (The Tubridge Plus For The Treatment Of Wide-Necked Intracranial Aneurysms)

A trial to evaluate the safety and efficacy of the Tubridge Plus flow-diverter stent for the treatment of intracranial wide-necked aneurysms.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-75 years old (as of the date of signing the informed consent form);
2. CTA, MRA or DSA angiography diagnosed as a large intracranial carotid artery or vertebral artery aneurysm (largest diameter of the aneurysm \>= 10mm) or medium to small aneurysms (maximum diameter \<10mm) (including saccular aneurysms and recurrent saccular aneurysms);
3. The neck of aneurysm 4mm or the body-to-neck ratio of aneurysm \< 2;
4. The diameter of the parent vessel is 2.0mm-6.5mm;
5. Subjects who are suitable for treatment with Tubridge Plus flow-diverted dense mesh stent alone or in combination with coils;
6. Subjects are willing to follow up and evaluate according to the requirements of the clinical trial protocol;
7. The subjects or their guardians can understand the purpose of the trial, participate voluntarily and sign the informed consent.

Exclusion Criteria:

1. Aneurysm related to AVM and MMD;
2. Ruptured aneurysm within 30 days;
3. Multiple aneurysms;
4. Subjects with significant stenosis (stenosis rate \>= 50%) or occlusion of parent artery
5. Recurrent aneurysms after stent or stent-assisted coil embolization;
6. Subjects with morphologies or lesions that may interfere with device use, including but not limited to: carotid artery dissection, vasculitis, Aortic dissection, restriction of vascular access (such as severe intracranial vascular tortuosity, severe intracranial vasospasm and no response to drug therapy, obstruction of device access due to other anatomical or clinical lesions);
7. Subjects who are not suitable for anesthesia or endovascular treatment, such as severe diseases of the heart, lung, liver, spleen, and kidney, brain tumors, severe active infection, disseminated intravascular coagulation, and a history of severe mental illness;
8. Subjects who underwent or plan undergo to major surgical operations (such as implantation of internal fixation devices for extremity fractures, tumor resection, major organ surgery, etc.) within 30 days before signing the informed consent form or 60 days after signing the informed consent form;
9. Modified Rankin score \>= 4 points ;
10. The life expectancy of the subjects is less than 12 months;
11. Subjects who have participated in clinical trials of other drugs or medical devices before enrollment and did not reach the end point.
12. The researchers judged that the subjects had poor compliance and could not complete the study as required;
13. Subjects with suspected history of allergy to nickel-titanium, platinum, platinum-iridium alloys and other materials;
14. Subjects who cannot receive antiplatelet aggregation or anticoagulation therapy;
15. Subjects have or may have had a serious reaction to the contrast agent and could not complete the pre-treatment medication;
16. Women who are pregnant or breastfeeding;
17. Other conditions deemed inappropriate by the investigator to participate in the study.
Effects of the Administration of Ornithine Phenylacetate in Patients With Cirrhosis and Upper Gastrointestinal Bleeding

The main objective is to evaluate the effectiveness of the experimental drug to reduce plasma ammonia concentration at a dose that is safe and well tolerated. Ammonia usually rises significantly in the hours after gastrointestinal bleeding in patients with cirrhosis of the liver. This increase in the concentration of ammonia facilitates the development of hepatic encephalopathy.

The study will be divided in two parts:

Part A: Open-label, dose-escalating, single cohort study. The goal of this phase is to confirm the tolerance and safety of the dose of OP that is being proposed for the study according to the results of phase I and phase II studies in healthy subjects and stable outpatients with cirrhosis.

Part B: Multi-center (2 University Hospitals), double-blind, randomized, parallel-group trial. Assignment of treatment will be done according to a list (one at each study site) of random numbers in blocks that will be concealed until the end of the study. The control group will be assigned to placebo on a 1:1 ratio. The placebo and treatment will be masked.


Eligibility Criteria:
Inclusion criteria

* Cirrhosis of the liver; diagnosed by clinical, laboratory or radiological findings.
* Upper gastrointestinal bleeding, as judged by clinical signs (hematemesis, melena, anemia) combined with endoscopic data.
* Bleeding that has been active within 24 hours prior to inclusion; signs of activity are defined by the presence of blood in the gastrointestinal tract and symptoms attributable to bleeding (hypotension, tachycardia, etc.).
* Age between 18 and 75 years.
* Informed consent by the patient. In case of inability to provide informed consent due to impaired mental status secondary to hepatic encephalopathy the informed consent should be provided by the next of kin and should be confirmed by the patient when he/she recovers from hepatic encephalopathy.
* Absence of exclusion criteria.

Exclusion criteria

* Terminal illness (e.g. advanced hepatocellular carcinoma).
* Need for mechanical ventilation.
* Renal impairment, defined by a creatinine \> 1.5 mg/dl or need of hemodialysis.
* Pregnant or breast-feeding. Pre-menopausal women capable of bearing children should be following a reliable method of birth control and should have a negative result in a pregnancy test prior to inclusion.
* Known or suspected hypersensitivity or allergic reaction to ornithine or phenylacetate.
* Use of medications known to interfere with the clearance of either ornithine and/or phenylacetate, such as antibiotics of the penicillin group and probenicid.
* Use of medications that may induce hyperammonemia; such as haloperidol, valproic acid, and systemic corticosteroids.
* History or known infection with human immunodeficiency virus (HIV).
* Neurological comorbidities that impair mental status and do not allow to adequately assess the presence or outcome of hepatic encephalopathy.
* The presence in the electrocardiogram of a QTcF \>500 msec
S(+)-Ibuprofen Effects on Asprin Treated Volunteers

The purpose of this clinical trial is to determine whether S(+)-ibuprofen affect the platelet inhibition under steady state acetylsalicylic acid conditions.


Eligibility Criteria:
Inclusion Criteria:

* Healthy caucasian volunteer
* Must be able to swallow tablets

Exclusion Criteria:

* Underlying diseases
* Ulcus pepticum in history
* Abuse of alcoholic beverages (40g/d)
* Hypersensitivity to investigational medicinal products
Pharmacokinetics (PK) and Safety of 2 Different Doses of Lopinavir/Ritonavir in in HIV/Tuberculosis (TB) Co-infected Patients Receiving Rifampicin Containing Anti-tuberculosis Therapy

To assess safety, efficacy and impact of Lopinavir/ritonavir 400/100mg bid or Lopinavir/ritonavir 600/150mg bid in combination with rifampicin-containing anti-TB therapy.

Fixed dose combination of d4T+3TC+NVP (GPOvir) is widely used in Thai HIV infected since June 2002. The prevalence of NNRTI resistance has increased since 2005. Tuberculosis can develop following NNRTI-based regimen failure or after introduction of a new salvage regimen with a boosted PI (immune recovery syndrome). Although, Efavirenz based HAART is preferred in TB/HIV with rifampicin containing antituberculosis. However, Efavirenz could not be used in case of NNRTI failure, intolerance or toxicity. It remains unknown how to optimally treat HIV /TB in populations in which rifampicin has to be used. Moreover, Rifabutin which is recommended when use concomitant with boosted PI4, 5, is not feasible in Thailand and other developing countries due to cost, toxicity and dosing considerations. If ritonavir-boosted LPV demonstrates suitable pharmacokinetics, and is well tolerated, this regimen might prove extremely useful and could be widely implemented. LPV/r is potent and widely available boosted PI in National Health System in Thailand. We therefore believe that there is a strong rationale and impetus for the study of LPV/r 400/100 mg bid versus LPV/r 600/150 mg bid as a boosted-PI combination that in the presence of RMP, is able to produce a satisfactory PK profile associated with adequate antiretroviral potency, tolerability and efficacy .

Eligibility Criteria:
Inclusion Criteria:

1. Confirmed HIV positive after voluntary counseling and testing
2. Aged \>18-60years of age
3. ARV naïve and NNRTI failure ( PI naive)
4. CD4+ cell count of \<350 cells/mm3 at the time of diagnosed TB
5. ALT \<5 times ULN
6. Serum creatinine \<1.4 mg/dl
7. Hemoglobin \>8 mg/L
8. TB is diagnosed and planned to receive stable doses of rifampicin-containing anti-TB therapy for at least a 2 week period after initiation of ART
9. No other active OI (CDC class C event), except oral candidiasis or disseminated MAC
10. Able to provide written informed consent

Exclusion Criteria:

1. Current use of steroid (except short course steroid for IRIS) and other immunosuppressive agents.
2. Current use of any prohibited medications related to drug pharmacokinetics.
3. Patients with current alcohol or illicit substance use that in the opinion of the site Principal Investigator would conflict with any aspect of the conduct of the trial.
4. Unlikely to be able to remain in follow-up for the protocol defined period.
5. Patients with proven or suspected acute hepatitis. Patients with chronic viral hepatitis are eligible provided ALT, AST \< 5 x ULN.
6. Karnofsky performance score \<30%