cyrilzakka/clinical-trials huggingface dataset:
An Investigation of the Absorption and Pharmacokinetics of Multiple Doses of Three Controlled Release Pregabalin Tablets as Compared to Multiple Doses of the Immediate Release Pregabalin Capsule

The purpose of this study is to 1) evaluate the extent of absorption of multiple doses of three pregabalin controlled release tablets as compared to multiple doses of the pregabalin immediate release capsule, 2) evaluate the pharmacokinetics of multiple doses of three pregabalin controlled release tablets as compared to multiple doses of pregabalin immediate release capsule and 3) evaluate the safety and tolerability of multiple doses of three pregabalin controlled release tablets as compared to multiple doses of the pregabalin immediate release capsule.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or females
* Between the ages of 18 and 55 years, inclusive
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2

Exclusion Criteria:

* Illicit drug use
* Pregnant or nursing females
* Females of childbearing potential who are unwilling or unable to use an acceptable method of contraception
Lyric4 Outcomes Evaluation

The goal of this clinical investigation is to obtain feedback on Lyric4 device updates within a cohort of experienced adult Lyric hearing instrument users. The main question it aims to answer is:

• Do device updates cause a change in Lyric patient experience?

Participants will be asked to complete questionnaires about their past experience with Lyric, as well as their experience with Lyric during the study period. They will also be asked to undergo aided audiometric testing with Lyric devices.


Eligibility Criteria:
Inclusion Criteria:

* Experience with Lyric hearing instruments
* Willingness to travel to the study site and complete study procedures
* Adults, age 18 or older
* Fluency with English (written/spoken)

Exclusion Criteria:

* No Lyric hearing instrument experience
* Ear health issues preventing Lyric fitting or requiring medical clearance prior to fitting
* Difficulty reading when corrected for vision loss
MPFL vs Campbell in Recurrent Patella Dislocation

This study will compare anatomic Medial Patellofemoral Reconstruction from Hamstring graft with non anatomic reconstruction according to Campbell. The purpose of this study is to evaluate which type of treatment recurrent patella dislocation provides to better clinical, radiological and laboratory outcomes.

Recurrent patella dislocation require surgery treatment. It provides to less cartilage degeneration and slow down knee osteoarthritis. Medial retinacular complex is injured in first time patella dislocation and its reconstruction is necessary. In literature there can be found many surgical reconstruction technics: anatomical or non anatomical (functional). But there is lack of evidence which technic provides to better outcomes - reduce the possibility to patella dislocation and progression of osteoarthritis in patellofemoral joint. Nowadays the choice of performed surgery depends on surgeons personal assessment.

Eligibility Criteria:
Inclusion Criteria:

* Recurrent patella dislocation
* No patellofemoral joint dysplasia or Dysplasia A/B according to Dejour (non operating)
* Acceptable is to perform concomitant medialization Tibial Tubercle Osteotomy

Exclusion Criteria:

* no informed consent to participate in the study
* age under 18 years or above 65
* multiligament injury or single plane knee instability
* another musculoskeletal disorders in lower limb
* lower limb deformity requiring axis correction: valgus
* femoral anteversion (CT measurements)
* joints inflammatory diseases
* concomitant patellectomy or trochleoplasty
* ASA score \> II
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181 in Healthy Subjects and Subjects With Mild to Moderate Ulcerative Colitis

To assess the safety and tolerability of single subcutaneous (SC) and intravenous (IV) doses of AMG 181 in healthy subjects and of a single SC dose in subjects with mild to moderate ulcerative colitis (UC)


Eligibility Criteria:
Inclusion Criteria: Healthy Volunteers

* Healthy male or female subjects of non-reproductive potential between 18 to 45 year-of -age
* Body Mass Index (BMI) between 18 and 34 kg/m2
* Normal physical and neurological examination, clinical laboratory values and ECG
* Additional inclusion criteria apply

Inclusion Criteria: Subjects with Mild to Moderate Ulcerative Colitis

* Male or female subjects between 18 to 55 year-of -age
* Body Mass Index (BMI) between 18 and 34 kg/m2
* Diagnosis of Ulcerative Colitis for at least 2 months
* Active, mild to moderate disease as defined by an Ulcerative Colitis Disease Activity Index (UCDAI, aka Mayo score) score of 4 to 9 (inclusive), with a minimum sigmoidoscopy score of 1
* Additional inclusion criteria apply

Exclusion criteria: Healthy Volunteers

* History or evidence of a clinically significant disorder (including psychiatric), condition or disease that would pose a risk to subject safety or interfere with the study evaluations, procedures or completion
* History of malignancy of any type, other than in situ cervical cancer or surgically excised non-melanomatous skin cancers within the past 5 years
* Recent or on-going infection(s)
* Underlying condition(s) that predisposes the subject to infections
* Additional exclusion criteria apply

Exclusion criteria: Subjects with Mild to Moderate Ulcerative Colitis

* Disease limited to the rectum, i.e. within 20 cm of the anal verge
* Any prior gastrointestinal surgery
* Evidence of severe disease (as evidenced by an Hb concentration \<11g/dL; toxic megacolon, or an UCDAI score≥10)
* Immunosuppressive therapy with either azathioprine, methotrexate, or mercaptopurine, within the past 3 months
* Prior exposure to a biologic agent or cyclosporine A
* Use of antibiotics within the past 2 weeks of screening and during screening period
* Use of topical (e.g. suppository or enema) mesalamine or steroids within two weeks prior to day 1
* Additional exclusion criteria apply
Long Term Extension Study in Patients With Primary Hyperoxaluria

The proposed study is designed to provide patients previously enrolled in Phase 1 and 2 studies of DCR-PHXC and their siblings (\<18 years old) long-term access to DCR-PHXC, and to evaluate the long-term safety and efficacy of DCR-PHXC in patients with PH.


Eligibility Criteria:
Key Inclusion Criteria:

•Participant successfully completed a Dicerna Pharmaceuticals, Inc. study of DCR PHXC.

OR Participant is the sibling of a participant who successfully completed a Dicerna Pharmaceuticals, Inc. study of DCR PHXC. Siblings must be younger than 18 years of age and must have genetically confirmed PH.

* For participants rolling over from a multidose study of DCR-PHXC, enrollment should occur within a window of 25 to 75 days from the last dose of study intervention.
* Estimated GFR at screening ≥ 30 mL/min normalized to 1.73 m2 body surface area (BSA), calculated using Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) formula in participants aged ≥ 18 years, or the multivariate equation by Schwartz in participants aged 12 months to 17 years. In Japan, the cystatin C-based Uemura formula will be used for participants aged 12 months to \<2 years, the creatinine-based Uemura formula by will be used for participants aged 2 to 17 years, and the equation by Matsuo will be used in participants aged ≥ 18 years.

Key Exclusion Criteria:

* Renal or hepatic transplantation (prior or planned within the study period)
* Plasma oxalate \> 30 µmol/L
* Currently on dialysis
* Documented evidence of clinical manifestations of systemic oxalosis
VIO Imaging for Skin Tissue Assessment (VISTA)

To demonstrate the safety and effectiveness of the VIO device in obtaining in vivo images that show tissue features including epidermis, dermis, collagen, blood vessels, and/or pigment.

To demonstrate that the tissue features identified on the images obtained with the VIO device align with the corresponding pathology images procured from the skin biopsy.

To evaluate the ability of blinded readers to correctly identify tissue features on images obtained with the VIO device.


Eligibility Criteria:
Inclusion Criteria:

1. The subject is between 18 and 99 years of age.
2. The subject or Legally Authorized Representative (LAR) is able and willing to provide written informed consent.
3. The subject is planning to undergo a routine skin biopsy.
4. The subject is willing and able to remain still for periods of up to 3 minutes to allow for image capture.
5. The subject or LAR has sufficient mental capacity to understand the informed consent form (ICF) and comply with the protocol requirements.

Exclusion Criteria:

1. The subject has a general health condition or systemic disease that in the opinion of the physician, precludes them from trial participation.
2. The subject has a known allergy or increased skin sensitivity to silicone, adhesives, or glycerin.
3. The subject's lesion targeted for biopsy:

   1. Is located on the palms of the hands, soles of the feet, fingernails, or toenails.
   2. Has dense hair that will not be removed prior to the skin biopsy.
   3. Has clinically significant abraded or ulcerated skin with or without discharge.
   4. Is associated with a wound or skin condition that in the opinion of the physician precludes them from participation
   5. Is located in mucosal tissue (i.e., oral, nasal, etc.).
   6. Is on tattooed skin.
   7. Is on a skin formation too tortuous for the investigational device to access (e.g., skin tags.)
   8. Is located in the periorbital region or directly on the eyelid.

      -
Effects of Carvedilol on Cardiotoxicity in Cancer Patients Submitted to Anthracycline Therapy

Neoplasia is the main cause of general death in the Brazilian population. In 2016, they were responsible for approximately 211,343 (16%) deaths, followed by cardiovascular diseases (12.6%). Despite the high mortality rate of neoplasia, oncological treatment have advanced substantially in recent decades improving the prognosis of patients. However, growing evidence suggest that some oncological agents may induce significant toxicity that may play a major role in the quality of life, morbidity and mortality. The cardiovascular system is often negatively affected with cancer therapy, predisposing several patients to stop appropriate treatments or to have cardiovascular events related to the cardiotoxicity. The most typical manifestation of cardiotoxicity and related consequences (heart failure) are related to the use of anthracyclines. Anthracyclines are part of the chemotherapy regimen for solid tumors and hematological neoplasms in children and adults, and are associated with an increase in life expectancy. Carvedilol is an α and β-blocker that also has antioxidant properties. Preliminary studies have shown that carvedilol and its metabolites prevent lipid peroxidation, inhibit the formation and inactivate free radicals, in addition to preventing the depletion of endogenous antioxidants, such as vitamin E. These effects would potentially prevent anthracycline injury but definitive evidence is still needed. This is a multi-center, double-blind, randomized, placebo-controlled study that aims to establish the efficacy of carvedilol for the primary prevention of left ventricular systolic dysfunction in cancer patients obtained with anthracycline chemotherapy, in different schedules and doses.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age at the time of screening
* Cancer patients that will receive chemotherapy with anthracyclines.

Exclusion Criteria:

* Inability to adequate asses left ventricular function
* Previous symptoms (dyspnea on exertion, orthopnea, paroxysmal nocturnal dyspnea, and pulmonary and systemic congestion) suggestive of or a previous diagnosis of heart failure.
* Previous history of any cardiomyopathy (eg.: valve disease, Chagas' disease, infiltrative cardiomyopathy)
* LVEF \< 50%
* Previous history of myocardial revascularization
* Permanent tachyarrhythmia (flutter, atrial fibrillation, atrial tachycardia)
* Congenital heart disease with left ventricular function impared
* Contra-indication to the use of beta-blockers.
* Pregnant or Breast-feeding females or women of childbearing age who intend to became pregnant.
* On kidney replacement therapy
* ECOG \>= 4 or Karnofsky \<=30
* Advanced hepatic failure (C score Child-Pugh and MELD \> 15);
* Previous use of anthracycline
* Have any serious concomitant systemic disease, condition, or disorder that, in the opinion of the investigator, should preclude participation in this study
* Are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
Common Safety Follow-up Trial of Tecemotide (L-BLP25)

This is an open-label, common follow-up trial. Subjects who were enrolled in a Merck KGaA, EMD Serono or Merck Serono Japan sponsored trial with tecemotide (L-BLP25) were enrolled in this follow-up trial to continue their maintenance treatment with tecemotide (L-BLP25). Subjects were transferred once the feeder trial (EMR 63325-005 \[NCT00157209\], EMR 63325-006 \[NCT00157196\] and EMR 63325-008 \[NCT01094548\]) objectives were met. Subjects who received tecemotide (L-BLP25) in a feeder trial continued tecemotide (L-BLP25) treatment in this follow-up trial and have safety assessments performed as well as were observed for progressive disease (PD) and survival in 6- month intervals. Subjects who had not received tecemotide (L-BLP25) in feeder trials, or discontinued treatment were only observed for PD and survival in 6-month intervals and were not provided treatment with tecemotide (L-BLP25).


Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent.
* Registration and treatment in a clinical trial with tecemotide (L-BLP25) under sponsorship of Merck KGaA/EMD Serono/Merck Serono Japan (feeder trial). \[Note, subjects who have been allocated to treatments not containing tecemotide (L BLP25) in the feeder trial are eligible for this trial and will be followed-up for progressive disease (PD) (if applicable) and survival.\]
* End of Treatment procedures have been performed in the feeder trial.
* Other protocol defined inclusion criteria could apply

Exclusion Criteria

* Pregnancy and lactation period; women of childbearing potential, unless using effective contraception as determined by the Investigator. Subjects whom the Investigator considers may be at risk of pregnancy will have a pregnancy test performed per institutional standard
* Known hypersensitivity to any of the trial treatment ingredients (if applicable)
* Legal incapacity or limited legal capacity
* Any other reason that, in the opinion of the Investigator, precludes the subject from participating in the trial
* Other protocol defined exclusion criteria could apply
Investigating Neural Processing of Social Stimuli

The primary goal of the present study is to test whether neural activity in brain regions associated with processing threat and social stimuli may underlie paranoid thinking.

Paranoia is a prominent symptom of psychosis that occurs in several other diagnoses, as well as the general population, and that is associated with significant distress and impairment. Previous research suggests that increased baseline activity of the amygdala and related neural circuits may serve as a mechanism for paranoid ideation. This exploratory study will use a paranoia induction procedure in healthy individuals who vary in pre-existing levels of paranoid ideation to test whether increases in self-reported paranoia are accompanied by increases in resting cerebral blood flow (CBF), decreased stimulus-driven neural activity in social processing networks, and increased behavioral perceptions of untrustworthiness.

Participants will be randomly assigned to participate in a paranoia induction procedure or a control condition and will then complete neuroimaging and behavioral assessments.

Eligibility Criteria:
Inclusion Criteria:

* between the ages of 18 and 55

Exclusion Criteria:

* current psychiatric diagnosis
* current use of psychotropic medications
* history of head trauma with loss of consciousness for more than 15 minutes
* presence of neurological or neurodegenerative disorder
* sensory impairments that preclude assessment
* presence of intellectual disability
* contraindications for MRI (e.g., metallic implants or pregnancy)
Keppra for Cervical Dystonia

The purpose of this study is to evaluate if there is an improved response in CD symptoms when Keppra is used as adjunctive therapy to Botox.

Up to 40 patients with cervical dystonia and receiving intermittent Botox injections will be enrolled in the study. Patients will be evaluated at baseline 12-16 weeks following their prior set of Botox injections. Patients will be evaluated using the TWSTRS Cervical Dystonia Scale. Any oral medications for the treatment of cervical dystonia will be stable for at least four weeks and will continue unchanged throughout the study. Following Baseline evaluation, subjects will undergo their standard set of Botox injections. This will consist of the same dose and approximate placement as their prior set of injections. Subjects will then be randomized to LEV or placebo. They will begin oral study medication beginning with an LEV dose of 250 mg each evening or placebo. There will be flexible dose titration increasing by 250 mg per week for 12 weeks to a maximum of 3000 mg divided BID. The subjects will be on a stable dose of medication for weeks 12 to 16 (or to week 20 in subjects with sufficient improvement that they do not require Botox injections). Subjects will be evaluated at weeks 4,8,12, 16, 20 and 24. The primary efficacy outcome measure will be the difference in change in TWSTRS score from baseline to week 16. Patients may undergo Botox injections prior to the week 16 visit if it is medically necessary or if the subject indicates that they are experiencing intolerable discomfort. In these cases, final evaluation will be performed prior to Botox injection and their scores will be carried forward to endpoint. Those subjects who have sufficient improvement such that they don't require Botox injections at or by week 16 will be monitored on study medication for an additional four weeks. Following Botox injection or 20 weeks, subjects will undergo a two-week off titration of study medication. Secondary outcome measures will include difference in change in TWSTRS score from baseline to weeks 4, 8, 12, 16, 20 and 24 in patient-reported pain scale, Clinical Global Impression scale, Clinical Patient Improvement scale, patient reported disability scale, and length of time between injections. Adverse events will be recorded and described. Serious Adverse events will be reported to the FDA in writing within 15 calendar days of knowledge of the event with a copy sent to UCB and the USF Internal Review Board.

A comparison across groups of the number of subjects who require injections prior to week 16 will be undertaken. In addition, a comparison across groups of the number of subjects not requiring injections at week 16 will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Patients will have received their last Botox injections 12-16 weeks ago
* Any oral medications for cervical dystonia will be stable for 4 weeks and will continue throughout the study

Exclusion Criteria:

* Less than 21 years old
* Received Botox more than 16 weeks ago
* Not on a stable dose of oral medications for cervical dystonia
BD-Covered Stent for Benign Esophageal Strictures: a Safety and Feasibility Study

A non-randomized prospective clinical, pilot study in a single centre assessing the safety and feasibility of the esophageal biodegradable covered stent for refractory benign esophageal strictures with or without fistulae

A non-randomized prospective clinical, pilot study in a single centre assessing the safety and feasibility of the esophageal biodegradable covered stent for refractory benign esophageal strictures with or without fistulae. The follow-up will be 6 months form implantation. After 3 months a control endoscopy will take place to evaluate stent and degradation process.

Eligibility Criteria:
Inclusion Criteria:

* Subjects of both genders
* Age ≥ 18 years
* Appropriate cultural level and understanding of the study
* Willingness to participate voluntarily in the study and give written informed consent
* Refractory benign esophageal stricture with or without fistulae, i.e. the patient has to pass a minimum of 2 and a maximum of 10 failed esophageal dilations to the minimal diameter of 15-mm, using a pneumatic balloon dilator or Savary bougie, not complicated by or malignancy.
* Ability to undergo periodic endoscopic follow-up.

Exclusion Criteria:

* Pregnancy or breastfeeding
* Simultaneous participation in another clinical study
* Life expectancy of less than 12 months
* Malignant esophageal stricture
* Stenosis after laryngectomy, or if the distance between the upper edge of the stent is less than 2 cm from the upper esophageal sphincter
* Undergone an esophageal stent implantation before.
Long-term Effects of COVID-19: a Comparative Cohort Study

This study is a longitudinal cohort study which investigates the effect of COVID-19 in ambulatory care. This study aims to assess the effect of COVID-19 beyond the acute phase, i.e. on long-term symptoms, respiratory and cardiovascular health, use of health services, and quality of life.

This study is a longitudinal cohort study comparing two cohorts. One cohort tested positive for SARS-CoV-2 and the other tested negative for SARS-CoV-2 matched by the timing of testing in the past 6 months. Participants will be observed for two years after their test for COVID-19 with online surveys at different time intervals and face-to-face follow-up visits.

Eligibility Criteria:
Inclusion Criteria:

Participants eligible for inclusion in this study for the exposed cohort with a diagnosis of COVID-19 in the last 6 months must meet all of the following criteria:

1. Aged 18 years or older;
2. Positive result on a rapid Ag test or PCR for SARS-CoV-2 for Covid-19 compatible symptoms a maximum of 6 months before inclusion;
3. Patient is community-dwelling;
4. Participant or their proxy is willing and able to give informed consent for participation in this study;
5. Participant is willing to comply with all study procedures.

Participants are sampled in the same practices as the exposed cohort and are eligible for inclusion in this study for the non-exposed without a diagnosis of COVID-19 in the last 6 months when they meet all of the following criteria:

1. Aged 18 years or older;
2. Tested because of suggestive symptoms with a rapid Ag test or PCR for SARS-CoV-2 at the same time (+/- 1 month) as the exposed cohort, of which the result was negative
3. Patient is community-dwelling;
4. Participant or their proxy is willing and able to give informed consent for participation in this study;
5. Participant is willing to comply with all study procedures.

Exclusion Criteria:

Participants eligible for the cohort with COVID-19 in the last 6 months must not meet any of the following criteria:

1. Patients in palliative care;
2. Patients for whom there is already someone from the same household participating;
3. Judgement of the recruiting clinician deems participant ineligible.

Participants eligible for the cohort without COVID-19 must not meet any of the following criteria:

1. A positive test for a SARS-CoV-2 infection in the last 2 years;
2. Patients in palliative care;
3. Patients for whom there is already someone from the same household participating;
4. Judgement of the recruiting clinician deems participant ineligible.

Prior vaccination against Covid-19 is not an exclusion criterion.