cyrilzakka/clinical-trials huggingface dataset:
A Single Dose Study of Oral Vadadustat in Subjects With Normal and Impaired Hepatic Function

This is a Phase I open-label study to evaluate the pharmacokinetic (PK) profile of a single oral dose of vadadustat in subjects with hepatic impairment(HI) compared to healthy matched control subjects with normal hepatic function.

This is an open label, parallel-group, single dose, Phase 1 study to evaluate the PK profile, safety, and tolerability of a single oral 450 mg dose of vadadustat in subjects with hepatic impairment relative to control subjects with normal hepatic function. The study will enroll up to 24 subjects in 3 groups of 8 subjects at 2 study sites. Blood samples for vadadustat PK and its metabolites will be collected pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 18, 24, 36, 48, 60, and 72 hours post-dose.

Eligibility Criteria:
Inclusion Criteria (All groups):

* Male or female subjects between ≥18 years and ≤70 years of age
* Have a body weight ≥45 kg and body mass index (BMI) ≥18.5 kg/m2 to 40.0 kg/m2

Additional Group-Specific Inclusion Criteria:

* Group 1 (Moderate Hepatic Impairment Subjects):

  * Presence of Moderate hepatic impairment (Child-Pugh Class B)
* Group 2 (Normal Hepatic Function Subjects):

  * Normal hepatic function
* Group 3 (Mild Hepatic Impairment Subjects):

  * Presence of mild hepatic impairment ( Child-Pugh Class A)

Exclusion Criteria (all groups):

* Renal impairment ≥ Stage 3 (estimated glomerular filtration rate \[eGFR\] \<60 mL/min/1.73m2 using the Modification of Diet in Renal Disease (MDRD) study equation)
* Any history of active malignancy within 2 years prior to or during screening, except for treated basal cell carcinoma of skin, curatively resected squamous cell carcinoma of skin, or cervical carcinoma in situ; any history of tuberculosis and/or prophylaxis for tuberculosis
* Positive test for human immunodeficiency virus (HIV) antibody at Screening.
* Hepatic or other organ or cell transplant
* Subjects with alcoholic cirrhosis must be sober for a minimum of 6 months
Data Analysis and Physical Function Evaluation Index Development for Early Diagnosis and Monitoring of ICU-acquired Weakness

Data Analysis and Physical Function Evaluation Index Development for Early Diagnosis and Monitoring of ICU-acquired weakness

ICU-acquired weakness (ICU-AW) is a prevalent complication, occurring in more than 50% of ICU patients, and has severe long-term effects on patient outcomes. This condition not only prolongs the duration of hospital stay but also persists long after discharge, continuously impacting patients' health and quality of life. Therefore, monitoring, prevention, and rehabilitation of ICU-AW should not be limited to the ICU period but should continue after transfer to general wards and after discharge. This study aims to provide foundational data for developing a platform capable of continuously monitoring and delivering rehabilitation therapy for ICU-AW from ICU admission through the post-discharge period.

Recent meta-analyses have shown that providing rehabilitation for ICU patients improves physical function at discharge, reduces ICU stay by 0.8 days, and shortens total hospital stay by 1.75 days. Additionally, it increases the distance patients can walk unassisted at discharge, the number of patients capable of standing, the duration of ventilator-free days, and the percentage of patients discharged home. Understanding the recovery process of ICU-AW as a continuum from ICU to post-discharge is essential, and the necessity of continuous rehabilitation throughout this process is evident. However, the challenge lies in implementing this in real-world practice.

This study seeks to provide foundational data for developing personalized educational programs applicable to remote digital therapeutics in the future.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the ICU who are 19 years of age
* Patients who did consent of the study

Exclusion Criteria:

* Patients with a history of peripheral nerve injury
* Patients with a history of major surgery within the past 12 weeks or those expected to undergo major surgery during the trial period
* Patients with a history of central nervous system disorders (e.g., stroke, spinal cord injury)
* Patients with cognitive impairment that may interfere with the conduct of the study
* Patients with Do Not Resuscitate (DNR) orders, brain lesions, Clinical Frailty Score (CFS) exceeding 4, or those who have undergone cardiopulmonary resuscitation
* Patients confirmed to have metastatic cancer
An Observational Study of Pegasys (Peginterferon Alfa-2a) in Patients With HBeAg-Positive or HBeAg-Negative Chronic Hepatitis B

This multicenter, prospective, observational study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) in routine clinical practice in patients with HBeAg-positive or HBeAg-negative chronic hepatitis B. Eligible patients receiving treatment with Pegasys according to standard of care and the summary od product characteristics/local labelling will be followed for the duration of treatment and up to 2 years of follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* HBeAg-positive or HBeAg-negative serologically proven chronic hepatitis B with or without cirrhosis
* Elevated serum ALT \> ULN (upper limit of normal) but \</=10 x ULN according to local label

Exclusion Criteria:

* Contra-indications to Pegasys as detailed in the label
* Co-infection with hepatitis A, hepatitis B or HIV
* Concomitant therapy with telbivudine (concomitant peginterferon alfa-2a therapy is contra-indicated according to telbivudine label)
* Pregnant or breastfeeding women
Transcranial Direct Current Stimulation in Offenders

This study investigates the effect of upregulating prefrontal cortex activity on risk-taking, and antisocial and aggressive behavior in violent offenders. In the double-blind, randomized controlled trial, using a within-subject crossover design, each participant will undergo anodal transcranial direct current stimulation of the right dorsolateral prefrontal cortex and sham stimulation. After each stimulation session, neural activity and behavioral responses to tasks assessing risk-taking and aggressive behavior will be recorded. The effect of tDCS on violent offenders will also be assessed in comparison to age and gender-matched healthy controls.


Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 50 years of age
* Able to understand the nature of the study and give informed consent
* Individuals in the violent offender group must have a record of repeated violent criminal offending (at least 2 felonies).
* Individuals in the violent offender group must have been convicted solely due to crimes involving violence motivated by impulsive aggression.

Exclusion Criteria:

* Presence of any contraindications for functional magnetic resonance imaging (fMRI)
* History of significant medical illness
* History of any neurological condition
* Diagnosis of schizophrenia
* History of epilepsy
* Head injury
* Mental retardation
Safety and Performance of MICRORAPTOR™ Suture Anchors in Shoulder and Hip

This is a prospective, multi-center, PMCF study to evaluate the safety and performance of the MICRORAPTOR REGENESORB suture anchors, MICRORAPTOR Knotless REGENESORB suture anchors, and MICRORAPTOR Knotless PEEK suture anchors implanted in 300 subjects needing reattachment of soft tissue to bone.

The purpose of this trial is to assess, by product, safety and performance post-market of the Microraptor Regenesorb, Microraptor Knotless Regenesorb, and Microraptor Knotless PEEK Suture Anchors. Approximately 18 sites (approximately 3 sites for study shoulder group and 3 sites for study hip group, per product) in the United States will participate in the study. This is an open-label study with consecutive enrollment. The study will continue for 24 months from the date that the last subject received the study treatment to the date that the last subject completes the study as planned. The study duration is planned for 36 months.

Eligibility Criteria:
Inclusion Criteria:

* Subject requires reattachment of soft tissue to bone for the following indications:

  * Shoulder - Capsular stabilization for Bankart repair, Anterior shoulder instability, SLAP lesion repairs, Capsular shift or capsulolabral reconstructions, Biceps tenodesis, Rotator Cuff Repairs (knotless anchors only)
  * Hip - Acetabular labrum repair/reconstruction
* Subject has consented to participate in the study by signing the EC-approved informed consent form.
* Subject is ≥18 years of age at time of surgery.
* Willing and able to make all required study visits.
* Able to follow instructions.

Exclusion Criteria:

* Known hypersensitivity to the implant material. Where material sensitivity is suspected, appropriate tests should be made and sensitivity ruled out prior to implantation.
* Pathological conditions of bone, such as cystic changes or severe osteopenia, which would compromise secure anchor fixation.
* Pathological conditions in the soft tissues to be attached that would impair secure fixation by suture.
* Comminuted bone surface, which would compromise secure anchor fixation.
* Physical conditions which would eliminate, or tend to eliminate, adequate anchor support or retard healing.
* The presence of infection.
* Conditions which would limit the subject's ability or willingness to restrict activities or follow directions during the healing period.
* Currently using tobacco products (cigarette, smokeless tobacco, ecigarettes, vaping etc.).
* Concurrent bilateral surgery.
* Prior MICRORAPTOR REGENESORB, MICRORAPTOR Knotless REGENESORB, or MICRORAPTOR Knotless PEEK implantation.
* Participation in the treatment period of another clinical trial within thirty (30) days of Visit 1, or during the study.
* Women who are pregnant or nursing.
* History of poor compliance with medical treatment.
* Prior ipsilateral surgeries performed on the joint space.
* Subjects with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.
High-Intensity-Interval-Training in Geriatric Rehabilitation - A Feasibility Study

Study with Patients (40-60 participants) above the age of 65. There will be a comparison of regular training on ergometer (10 trainings within 2 weeks, 40 min each) to high intensity interval training on ergometer (6 trainings within 2 weeks, 25 min each). At the beginning and at the end will be a spiroergometer to measure the individual limits and vO2max, which will be compared amongst the two groups. To receive a subjective feedback, there will be a series of questionnaires at the beginning, after one week and at the end. The goal of this study is to get more information about whether a HII-Training is feasible with elderly patients and whether they can profit form it.


Eligibility Criteria:
Inclusion Criteria:

* cardiopulmonal resilient
* able to sit on a ergometer
* knowledge of German written and spoken

Exclusion Criteria:

* Severe cardiopulmonary restriction (LVEF \<30%, conduction abnormalities from AV block IIb or higher)
* Absolute cardiopulmonary contraindications (acute coronary syndrome, unstable AP -\> not capable of rehabilitation), uncompensated heart failure (dyspnea at rest, orthopnea, severe edema)
* No ischemic events (cardiac, cerebral, peripheral) within the last 3 months
* Severe pneumatological underlying disease: COPD GOLD 3 and higher or status after exacerbation within the last 2 weeks, Asthma grade 4
* Dyalisis reliant
* Severe psychiatric disorder (severe psychosis, severe depression)
* Distinct dementia
Effectiveness of Psychological Interventions in Haemophilia

The purpose of this study is to evaluate the relative effectiveness of two psychological interventions, cognitive-behavioral therapy (CBT) and hypnosis (Hyp), in preventing and managing pain, regulating emotional state and improving quality of life in Portuguese PWH.

22 (People with Haemophilia) PWH will be included in each group (Hypnosis, CBT and control-no intervention) (total=66). Sample size was calculated using G\*Power 3.1.4 and considering the following assumptions: to perform a one-way ANOVA with fixed effects, a large effect size (f =0.4), a significance level (α - type I error) of 0.05 and a statistical power (1-β - type II error) of 0.80.

The patients will be approached by clinicians of the Immunohaemotherapy Department and the psychologists for the explanation of the study, confidentiality and voluntary nature of participation. Patients who agree to participate will be asked to read and sign the Informed Consent document. Afterwards, the first assessment moment will take place in order to get a baseline assessment of each patient (T0: pre-test). Subsequently, the blind randomization to one of the 3 conditions will occur and the 4 individual intervention sessions will be scheduled, occurring in a weekly basis (90 minutes per session).

The post-test assessment (T1) takes place one week after the last intervention session (in the 5th week), and the follow-up assessments (T2, T3 and T4) will occur subsequently at 3 months, 6 months and one year post-intervention.

A physiological assessment will be performed at T1, T2 and T4. This will be performed through the collection of blood samples in order to achieve a systemic evaluation of pro-inflammatory and anti-inflammatory cytokines. A CBC (Complete Blood Count) with White Blood Count and C Reactive Protein (CRP) analysis will also be performed. Upon arrival at the Immunohaemotherapy Department (between 9:30 am and 1:30 pm), patients will undergo sample blood collection and EDTA-samples will be transported immediately to the lab.

In the lab, blood samples are centrifuged 15 minutes at 3.000 rpm, and plasma aliquoted and stored in a freezer at -80 ºC, until further analysis. Plasma levels of cytokines (IL-6, IL-1β, TNF-α, IL-10) are assayed in duplicate using ultra-sensitive multiplex human ELISA kits (Life Technologies®).

Functional Assessment of the joints will be performed through the Gilbert (based on clinical evaluation) and Pettersson Scores (based on X-ray and ultrasonography).

All study procedures will comply with the applicable ethical guidelines.

Eligibility Criteria:
Inclusion Criteria:

* Mild pr severe Haemophilia A or B
* Age of 18 or older
* Ability to write and read

Exclusion Criteria:

* Other comorbid life threatening diseases, such as cancer
* Neurological or psychiatric deficits
* Acquired Haemophilia
Role of GLP-1 in Hyperinsulinemic Hypoglycemia Post-bariatric Surgery

The purpose of this study is to evaluate the role of GLP-1 in causing extreme postprandial glucose reductions after bariatric surgery in a subset of patients who have severe symptomatic hypoglycemia.

The physiologic mechanisms mediating the glucose-lowering effect of Roux-en-Y Gastric Bypass (RYGB) or post-Vertical Sleeve Gastrectomy (VSG) are unknown. The reduction in glucose excursions prior to weight loss has lead to postulates that the incretin hormone, GLP-1, may play an important role.

The purpose of this study is to evaluate the role of GLP-1 in causing extreme postprandial glucose reductions in a subset of post-bariatric patients through the pharmacologic blockade of the GLP-1 receptor in post-RYGB or post-VSG patients with severe symptomatic hypoglycemia.

Eligibility Criteria:
Inclusion Criteria:

* Men and women ages 18-65
* BMI 25-40 with a clinical diagnosis of severe symptomatic hypoglycemia after bariatric surgery

Exclusion Criteria:

* Acute medical illness, such as acute bacterial or viral syndrome, febrile illness, acute abdominal symptoms, orthopedic injury within one week
* History of cardiac failure, renal insufficiency (estimated Crcl\<30cc/min), hepatic insufficiency, chronic obstructive pulmonary disease, anemia (Hct\<30%), or uncontrolled hypertension (SBP\>160 or DBP\>100)
* Pregnancy
* Use of medications that affect glucose metabolism
* Fasting glucose \>150 or HbA1c\>7.5 on Metformin
* Women of childbearing potential (will have a pregnancy test, in addition use of abstinence for at least one month prior to study or use two types of contraceptives, hormonal implant or Depo Provera)
* Active, uncontrolled psychiatric disease
* Participating in other studies or have received investigational medications within the past month or 5 half-lives of the drug, whichever is longer.
Chagas Disease Diagnostic - Inconclusive Serology

T. cruzi infection affects approximately five million people in Brazil. The diagnosis of the chronic phase of infection is performed by indirect serological methods which, nevertheless, leave inconclusive results. One of the direct methods used for T. cruzi identification, blood culture in LIT (liver infusion tryptose) medium, presents low sensitivity in that phase of the disease. A negative result does not eliminate the possibility of infection, but a positive test has high absolute diagnostic value, which enables the indication of antiparasitic treatment. Molecular diagnosis (PCR) in this phase is promising and can be used as a confirmatory test, particularly when individuals present inconclusive results in conventional serological tests, such as ELISA, HAI and IFI. This study aimed at improving blood culture sensitivity in LIT medium by performing PCR in individuals with positive and inconclusive serology for chagasic infection.


Eligibility Criteria:
Inclusion Criteria:

* individuals with positive or inconclusive results in conventional serological tests: ELISA, HAI and IFI for Chagas disease
Maintaining Independence and Quality of Life in Aging Adults Through Targeted Cognitive Training

Mild Cognitive Impairment, Alzheimer's Disease and Parkinson's Disease all represent a range of degenerative conditions that have cognitive impairments which all limit the ability for older individuals to self-manage care, participate in daily activities and community participation. The consequences of these progressive diseases increase the requirement for residential care, associated medical costs and may negatively impact the overall quality of life and mental health for individuals. According to the Alzheimer Society of Canada, over the next few decades, more than 1 million Canadian's will be living with decreased cognitive ability and will require an increased amount of support, whether through family or institutional sources.

Currently, there are few cognitive programs for individuals diagnosed with mild cognitive impairment or for individuals wishing to maintain their current level of cognitive ability which translates to meaningful improvements in daily living and independence, as well as generalized intelligence. To date, the Watson Centre Society for Brain Health (WCSBH) has successfully improved cognitive capacity, executive function and quality of life for over 100 individuals following a wide range of brain injury, and currently has a 77% return to work rate following completion of the full program. The program includes a combination of physical exercise, cognitive training and mindfulness meditation.

The purpose of the research study is to explore the impact of an interdisciplinary cognitive rehabilitation program has upon the cognitive functioning and quality of life for individuals who are assessed to have mild cognitive impairment (MCI). In particular, the aims of this study include: 1) To evaluate changes in cognition and quality life in older adults with MCI. 2) To explore the potential for intensive cognitive intervention in slowing cognitive degeneration in older adults with MCI.


Eligibility Criteria:
Inclusion Criteria:

* T-MoCA score between 19 - 23

Exclusion Criteria:

* Potential participants are under the age of 65 years at the time of screening
* Scoring results in a range outside of 19-23 on the MoCA
* Those who have have a diagnosed illness or diagnosed injury which is known to directly and negatively impact cognition
* Are known (legally) to be deemed incapable; unable to appreciate information that is relevant to making decisions or is unable to appreciate the reasonably foreseeable consequences of either making or not making a decision.
Adjunctive Treatment for Chronic Rhinosinusitis With Nasal Polyposis

This is a research study to find out if an off-label use of carboxymethylcellulose foam (CMC), an absorbable nasal packing, combined with triamcinolone acetonide, a steroid, is more comfortable postoperatively for participants and is as effective in decreasing scarring, swelling and crusting after surgery than an FDA approved steroid eluting implant. Anticipated sample size will be 30. Study is an intrapatient control design. Subjects will be randomly assigned to receive CMC foam with triamcinolone in one nare and the steroid-eluting implant in the other. Participants will fill out preoperative and follow-up visit surveys at 7, 14, 30 and 90 days. Subjects at each visit will also have pictures taken of the nasal cavities to be scored for later analysis. Paired t-tests will be performed for analysis.

Our primary objective is to demonstrate that triamcinolone-impregnated carboxymethylcellulose foam is noninferior to steroid-eluting implants in improving postoperative ethmoid inflammation, middle turbinate position, preventing intranasal synechiae and reducing polypoid change with objective measurement scales Our secondary objects include assessing the quality-of-life and nasal obstruction symptoms before and after functional endoscopic sinus surgery with validated SNOT-22 and NOSE questionnaires and to assess the cost-effectiveness of triamcinolone-impregnated carboxymethylcellulose foam versus steroid-eluting implant in management of CRSwNP in the early postoperative period.

The endpoints are the POSE scores, the SNOT-22 and NOSE scores at days 7, 14, 30 and 90.


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Diagnosis of nasal polyposis and desiring surgery

Exclusion Criteria:

* A known history of intolerance to corticosteroids
* An oral steroid-dependent condition
* A history of immune deficiency
* Pre-existing narrow angle glaucoma or cataracts
* Subjects that did not complete the pre-op medical regimen described below
* Pregnant and/or breastfeeding
Wearable Devices to Monitor Seizures in Autoimmune Epilepsy

The purpose of this research is to search for reproducible changes in a wide range of physical signals, including heart rate, muscle tone and activity and EEG before and at the onset of seizures in patients with epilepsy.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with or suspected of having autoimmune epilepsy.
* Normal controls - cognitively normal subjects without epilepsy

Exclusion Criteria:

• Cognitive or psychiatric condition rendering patient unable to cooperate with data collection or manage and recharge smart watch and tablet computer devices. Presence of open or healing wounds near monitoring sites (infection risk).