cyrilzakka/clinical-trials huggingface dataset:
A Study to Investigate the Pharmacokinetics of Baxdrostat When Given Alone and in Combination With Itraconazole in Healthy Participants

The main purpose of this study is to assess the effect of itraconazole on the pharmacokinetic (PK) of baxdrostat.

This study will be an open-label, 3-period fixed sequence study conducted at a single Clinical Unit.

The study will comprise of:

* A Screening Period of maximum 28 days
* Period 1: Period 1 will start from Day -1 to Day 6 (followed by pharmacokinetic (PK) sampling of baxdrostat). Baxdrostat administration on Day 1 to Day 6
* Period 2: Period 2 will start from Day 6 (after the last PK sample in period 1) to Day 8. Itraconazole administration on Days 6 to 8 (twice a day \[BID\] on Day 6 and once daily \[QD\] on Days 7 and 8)
* Period 3: Period 3 will start from Day 9 to Day 17. Baxdrostat administration on Day 9 and itraconazole administration on Days 9 to 16 QD
* A Final Follow-up Visit at 7 to 14 days after the last baxdrostat PK sample in Period 3

All participants will receive 2 single doses of baxdrostat and 12 doses of itraconazole, under fed conditions.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female participants of non-childbearing potential aged 18 to 55 years with suitable veins for cannulation or repeated venipuncture.
* All female participants must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit (Study Day -1).
* Have a body mass index between 18 and 32 kilograms per meter square (kg/m2) inclusive and weigh greater than or equal to (\>=) 50 kilograms (kg) and less than or equal to \<=) 120 kg.

Exclusion Criteria:

* History of any clinically important disease or disorder which, in the opinion of the principal investigator (PI), may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.
* History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
* History of drug-related hepatic toxicity.
* Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of study intervention.
* History of any treatment with QT prolongation drugs.
* History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, as judged by the PI or history of hypersensitivity to drugs with a similar chemical structure or class to baxdrostat or itraconazole.
* Participants who have previously received baxdrostat.
Geniculate Nerve Block Versus Adductor Canal Block for ACL Reconstruction Surgery

Anterior cruciate ligament repair (ACL) surgery presents moderate to severe pain during the inmediate postoperative period and the first days after surgery. In addition, due to the interest of surgeons and patients for early reinstatement, the use of blockages that decrease the strength of the quadriceps is avoided. Therefore, in recent years, the adductor canal block (ACB) has been used for postoperative analgesia with variable results.

Genicular nerve block (GNB) has been used for pain management in patients with knee osteoarthritis and recently in knee arthroplasty surgery with results similar to the local anesthetic infiltration techniques by the surgeon (LIA). Considering their good results in these patients in addition to being a 100% sensitive block without risk of motor involvement.

The investigators proposed this experimental study to evaluate tha analgesic efficacy of the genicular nerve block (GNB) compared with the adductor canal block (ACB) for the Anterior cruciate ligament (ACL) repair surgery.

Participants scheduled to undergo anterior cruciate ligament reconstruction under general anaesthesia will be allocated to two groups: Adductor canal block or Genicular nerve block- The adductor canal block will be performed by the anaesthesiologist under ultrasound guidance prior the surgery, after inducction , using 20 mLs Ropivacaine 0.2%. The genicular nerve block will be performed by the anaesthesiologist under ultrasound guidance prior the surgery, after inducction , using 20 mLs Ropivacaine 0.2% in total.

Postoperative analgesia will include analgesia (Dexketoprofen 75 mg during first 24 hours), acetomiophen 1 gr every 8 hours and tramadol for rescue pain.

Eligibility Criteria:
Inclusion Criteria:

* Patients from 18 to 50 years old scheduled to undergo anterior cruciate ligament reconstruction

Exclusion Criteria:

* peripheral neuropathy
* pre-existing femoral neuropathy
* diabetes mellitus
* alcoholism
* drug addiction
* cancer with chemotherapy
* chronic pain state
* Negative of the patient to participate in the study.
Efficacy Study of Nivolumab Compared to Docetaxel in Subjects Previously Treated With Advanced or Metastatic Non Small Cell Lung Cancer

The purpose of this study is to determine whether Nivolumab improves life expectancy compared to Docetaxel in Subjects with Advanced or Metastatic Non-small Cell Lung Cancer who have failed prior platinum-based doublet chemotherapy.


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Disease progression experienced during or after one prior platinum containing doublet chemotherapy
* Stage IIIb/IV or recurrent disease
* Male and Female ≥ 18 years of age
* Measurable disease per RECIST 1.1
* Performance Status ≤ 1

Exclusion Criteria:

* History of Carcinomatous meningitis
* Active Central nervous system (CNS) metastases
* History of auto immune diseases
* Prior treatment with Docetaxel
* Prior treatment with ipilimumab or any drug targeting T-Cell costimulation or checkpoint pathways
Light Treatment Effectiveness (LITE) Study

To compare the effectiveness, safety (tolerability), and duration of treatment response at 12 weeks of home versus office-based narrowband ultraviolet B phototherapy for the treatment of psoriasis

The primary objective of this study is to compare the effectiveness, safety (tolerability), and duration of treatment response at 12 weeks of home versus office-based narrowband ultraviolet B phototherapy for the treatment of psoriasis. Physician Global Assessment (PGA) and Dermatology Life Quality Index (DLQI) will be used to assess effectiveness, safety (tolerability), and duration of treatment response. This is a three year pragmatic, randomized, active comparator effectiveness study.

Eligibility Criteria:
Inclusion Criteria:

1. Willing and able to provide informed consent (age 18+) or parental permission and assent (ages 12-17)
2. Age 12 or older
3. Plaque or guttate psoriasis predominantly located on trunk and/or extremities, with a physician global assessment average of \>1.0, and considered a candidate for phototherapy
4. Patient is deemed willing and able to comply with either in-office or in-home phototherapy:

   1. In office: Able to travel about 3 times per week for 12 weeks from home, work and/or school during business hours of local site
   2. In home: Has space to accommodate home phototherapy unit and patient (or if 12-17, parent), willing and able to follow home phototherapy instructions
5. New or established patient in the practice

Exclusion Criteria:

1. Patients who are judged unable or unwilling to comply with either in office or in home phototherapy due to time, work, school, or other financial constraints
2. Patients judged unable to follow home phototherapy protocol due to failure to demonstrate understanding of the following:

   1. How to operate the phototherapy device
   2. How to follow the dosing protocol
   3. Requirement to wear protective eyewear and genital protection equipment
3. Patients with known history of lack of efficacy to phototherapy or treated with phototherapy 14 days prior to baseline visit
4. Psoriasis predominantly located on scalp, body folds, genitals, palms and/or soles or with a physician global assessment average of ≤ 1.0
5. Patients deemed unsafe to be treated with phototherapy:

   1. History of photosensitivity or autoimmune disease such as lupus or dermatomyositis which can be aggravated by ultraviolet radiation
   2. History of arsenic intake
   3. Unable to tolerate standing for required duration of treatment due to age or physical function
   4. History of melanoma or multiple non-melanoma skin cancers that in the opinion of the principal investigator contraindicates treatment with phototherapy
6. Clinical site deems the participant is ineligible for reason other than eligibility or screening criteria.
Roll-over Study to Collect and Assess Long-term Safety of Everolimus in Patients With TSC and Refractory Seizures Who Have Completed the EXIST-3 Study [CRAD001M2304] and Who Are Benefitting From Continued Treatment

The purpose of this study is to evaluate the long-term safety in patients with TSC and refractory seizures who are currently receiving everolimus treatment in the Novartis-sponsored EXIST-3 study and who are determined to be benefiting from continued treatment as judged by the investigator at the completion of EXIST-3

This is a multi-center, open label study to evaluate the long term safety of everolimus in patients with TSC and refractory seizures currently being treated in the Novartis-sponsored study EXIST-3 study and are judged by their parent study investigator as benefiting from the current study treatment. The study is expected to remain open for approximately 10 years (or until 31-Dec-2022 in the UK) from First Patient First Visit (FPFV).

Patients will continue to be treated in this study until they are no longer benefiting from their everolimus treatment as judged by the Investigator or until one of the protocol defined discontinuation criteria is met or everolimus becomes commercially available according to local regulations.

Eligibility Criteria:
Key Inclusion Criteria:

* Patient is currently enrolled in the Novartis-sponsored EXIST-3 study, receiving everolimus, and has fulfilled all its requirements
* Patient is currently benefiting from treatment with everolimus, as determined by the Investigator.
* Patient has demonstrated compliance, as assessed by the Investigator,with the parent study protocol requirements.
* Patient is willing and able to comply with scheduled visits and treatment plans.
* Written informed consent/adolescent assent obtained prior to enrolling into the roll-over study.

Key Exclusion Criteria:

* Patient has been permanently discontinued from everolimus study treatment in EXIST-3 study
* Everolimus is approved for patients with TSC and refractory seizures and is reimbursed in the local country.
* Patients who are receiving everolimus in combination with unapproved or experimental treatments for seizure control Anti-epileptic drug (AEDs) are allowed for the purpose of seizure control.
Efficacy and Safety of Oral UT-15C Tablets to Treat Pulmonary Arterial Hypertension

This study is an international, multi-center, randomized, double-blind, placebo-controlled study in subjects with PAH who are currently receiving approved therapy for their PAH (i.e., endothelin receptor antagonist and/or phosphodiesterase-5 inhibitor). Study visits will occur at 4 week intervals for 16 weeks with the key measure of efficacy being the 6-minute walk test. Study procedures include routine blood tests, medical history, physical exams, disease evaluation, and exercise tests.

Patients who complete all assessments for 16-weeks will also be eligible to enter an open-label, extension phase study (FREEDOM - EXT).


Eligibility Criteria:
Inclusion Criteria:

* A subject is eligible for inclusion in this study if all of the following criteria apply:
* Between 18 and 75 years of age, inclusive.
* Body weight at least 40 kg (approximately 90 lbs.)
* PAH that is either idiopathic/heritable; associated with appetite suppressant or toxin use; associated with collagen vascular disease; associated with repaired congenital shunts; associated with HIV.
* Currently receiving an approved endothelin receptor antagonist and/or an approved phosphodiesterase-5 inhibitor for at least 90 days and on a stable dose for at least the last 30 days.
* Baseline six-minute walk distance (6MWD) between 150-425 meters
* Previous testing (e.g., right heart catheterization, echocardiography) consistent with the diagnosis of PAH.
* Reliable and cooperative with protocol requirements.
Intervention of HIV, Drug Use and the Criminal Justice System in Malaysia

The purpose of this study is to evaluate the relative impact a medical drug (methadone) or behavioral counseling program (Holistic Health Recovery Program) or both (methadone and Holistic Health Recovery Program) has on reducing HIV-related risk behaviors and illicit drug use among opioid-dependent, HIV-infected individuals in prison when given 90 to 180 days prior to leaving prison.


Eligibility Criteria:
Inclusion Criteria:

* HIV-infected
* Clinical Diagnosis of Opioid Dependence
* Fluent in Bahasa Malaysia or English
* Within 90 to 180 days of release from prison
* Planning to live in Klang Valley region after release from prison
* Able to provide informed consent

Exclusion Criteria:

* Pregnancy or planning to become pregnant (female only)
The Comparison Between HepaSphere Drug-eluting Bead Transarterial Chemoembolization Combined With Hepatic Arterial Infusion Chemotherapy in Advanced Hepatocellular Carcinoma

Transarterial chemoembolization (TACE) is widely applied and shows good efficacy in advanced hepatocellular carcinoma (HCC). Recently, hepatic arterial infusion chemotherapy (HAIC) has also gained popularity in the treatment of HCC. Several studies have described the comparison between HAIC and TACE or TACE combined with HAIC. However, the evaluation between TACE plus HAIC and HAIC is rarely reported. Here, we will evaluate the performance of HepaSphere DEB-TACE combined with HAIC (HEPA-HAIC) comparing to HAIC in patients with advanced HCC

This is a double-arm, retrospective, observational study. The patients diagnosed as advanced HCC and treated with HepaSphere plus HAIC or single HAIC in the interventional therapy department of Peking University Cancer Hospital \& Institute from May 2018 to May 2022. These patients are grouped into two cohorts. One is HEPA-HAIC group, the other is HAIC group. To access the effect of HepaSphere plus HAIC and single HAIC on the treatment of advanced HCC, the treatment efficacy and safety will be analyzed between these two cohorts. To avoid the selection bias, Propensity score matching (PSM) will be also conducted. The primary endpoints are progression-free survival (PFS) and overall survival (OS); the secondary endpoint includes objective response rate (ORR), disease control rate (DCR) and safety

Eligibility Criteria:
Inclusion Criteria:

* Age: ≥18 years old
* Gender: no limitation
* Diagnosed as primary hepatocellular carcinoma histologically or clinically
* Imaging data within 31 days at enrollment and at least one measurable lesion (according to mRECIST criteria) is available
* Patients only received treatment with HepaSphere combined with hepatocellular arterial infusion chemotherapy (HAIC) or HAIC alone during the observation period
* Child-Pugh: A-B
* ECOG: 0-2.

Exclusion Criteria:

* Other cancer diseases are co-existed
* Drug-eluting beads from other manufacturers were used during DEB-TACE
* DEB-TACE combined with HAIC or HAIC alone was used as postoperative adjuvant therapy
* Pre- or post-surgery relevant examination results were unavailable
* Imaging information for effectiveness evaluation was unavailable
* Follow-up failure due to patient information errors, loss, refusal, etc
Sleep and Nocturnal Melatonin in Adults With Attention Deficit Hyperactivity Disorder (ADHD)

This study will investigate the effects of methylphenidate on sleep in adults with Attention Deficit/ Hyperactivity Disorder (ADHD) using polysomnographic parameters.

Previous studies in children with Attention Deficit/ Hyperactivity Disorder (ADHD) have described the effect of stimulants on sleep patterns. However the data on adults with ADHD is sparse.

The aim of this study is to investigate the effects of methylphenidate on sleep in adults with ADHD using polysomnographic parameters.

Eligibility Criteria:
Inclusion Criteria:

* ADHD according to DSM-IV Criteria
* Positive ASRS questionnaire

Exclusion Criteria:

* Brain damage
* Brain encephalopathy
* Borderline IQ
* Affective disorder
Observational Study of THC Concentrations in Acute Cannabinoid Intoxication

This observational study is being conducted to determine plasma concentrations of tetrahydrocannabinol (THC) and its metabolites, 11-OH-THC and THC-COOH, in plasma of subjects who visit the emergency department due to acute cannabinoid intoxication.

This is a multi-center, prospective, cross-sectional observational study to determine the concentrations of tetrahydrocannabinol (THC) and its metabolites (and/or other cannabinoids) in the plasma of subjects admitted to emergency departments with acute cannabinoid intoxication The study will explore the relationships between these concentrations and parameters such as demographics, symptom severity, time to symptom resolution, and clinical outcomes.

Samples will be collected as part of standard clinical procedure without requiring study participants to spend additional time in the hospital.

Eligibility Criteria:
Inclusion Criteria:

1. Subject visits emergency department for acute cannabinoid intoxication as evidenced by the following criteria:

   1. Recent cannabis use within the last 12 hours
   2. Clinically significant physiological abnormalities associated with cannabis use or problematic behavioral or psychological changes (e.g., altered perception, impaired motor coordination, euphoria, anxiety, a sensation of slowed time, impaired judgment, social withdrawal) that developed during, or shortly after, cannabis use
2. Subject (and/or parent/LAR when required) has the ability to communicate with comprehension with the study personnel at the time of consent/assent and the gathering of data other than plasma samples.
3. Subject (and/or parent/LAR when required) is willing and able to provide informed consent/assent.

Exclusion criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:

1. Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.
2. Individuals under the age of 18 who do not have a parent or legal representative present during the time at the ED.
3. Patients presenting with signs or symptoms attributable to another medical condition or better explained by another mental disorder.
4. Patient presenting with cannabis hyperemesis syndrome (CHS) or cannabis withdrawal syndrome (CWS)
5. Patients who are brought in by law enforcement, i.e., cannabis intoxication associated with a vehicle accident (driving under the influence).
Effect of Cervicothoracic Mobilization on Upper Crossed Syndrome

PURPOSE: To investigate the effect of cervicothoracic mobilization on Craniovertebral angle (CVA), sagittal shoulder angle (SSA), kyphotic angle and pain intensity level in upper crossed syndrome.

Upper crossed syndrome and its associated neck pain is considered to be the fourth most frequent cause of disability with an annual 30% increase in the rate of prevalence. According to the report on Global burden of diseases (GBD) 2010, neck pain is ranked 21st in terms overall burden of diseases. Musculoskeletal pain in the neck and upper limbs is common; population studies suggest that 6-48% of adults have pain in one of these areas .

Recently, joint mobilization has proven to be effective, and it is now frequently used in clinics .Cervical mobilization combined with thoracic mobilization is recommended as a clinical intervention for neck pain patients with forward head posture ( FHP) rather than cervical mobilization alone. This study has two groups; one will receive cervicothoracic Mobilization + conventional treatment and the second will receive conventional treatment for eight weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 20-50 years .
2. Participants will included if their CVA less than 48° ( SSA less than 52°) , as above these values are considered normal and thoracic kyphosis (with flexicurve angle more than 45 degrees) .
3. Subjects who have weakness in deep neck flexors, serratus anterior, middle and lower trapezius and rhomboid muscles and tightness in upper trapezius, levator scapulae, scalene, posterior neck and suboccipital muscles, pectoralis major and minor and sternocleidomastoid muscles.
4. Subject complaining of this symptom for more than 3mothes.
5. Marking pain intensity score visual analog scale (VAS) ≥3 in neck and shoulder

Exclusion Criteria:

1. History of surgery or joint diseases of the spine or shoulder.
2. Osteoporosis, or fracture ,cervical instability or any sign those with other contraindications against joint mobilization.
3. Individuals with any cervical condition e.g. radiculopathy, cervical rib, whiplash injury and individuals with any neurological/ condition .
4. History of congenital spinal deformity (congenital scoliosis) .
5. Any malignancy related to soft tissue and joints .
6. Subjects taking analgesics and/or muscle relaxants.
7. pregnancy.
8. Being in weight out of the normal range (18 ≥ BMI ≥ 25).
9. Cognitive impairment and inability to understand the scale.
Cohort Prospective Study of Children With Head and Neck Cystic Malformation Who Are Treated With Intracystic OK432

Cohort study evaluate the efficacy treatment with OK-432 in cystic malformation of the head and neck region.

The malformations are macrocystic and the preevaluation will include CT/MRI, US and blood tests.

The injection will be in the OR under US guided, maximal dose will be 0.2mg. The follow-up will be of short term - till 30 days post injection and long term - follow-up wil be till 2 years.

A cohort study, before the injection all the patients in the study will go through:

1. CT/MRI
2. US to estimate the cyst size
3. CBC, PT, PTT, INR, ASLO
4. ECG If the patient is qualified to the study the parent will sign on the inform consent, than the child will be photographed AP and lateral.

The injection will be held in the OR under US guidance with 18q20 gauge needle, first all the cyst contents will be sucked than the OK432 will be injected in.

After the injection the child will stay for one night if it was general anesthesia and 4 hours in the case of local anesthesia.

Short term follow - 3-5 days with the phone, up: till 30 days from the injection with US, stills photo.

Long term follow-up: 6 months, 1 year, 2 years

Eligibility Criteria:
Inclusion Criteria:

* LYMPHATIC MALFORMATION MACROCYSTIC OR MIXED WITH MORE THEN 50% MACROCYSTIC.
* ONLY IN THE HEAD AND NECK AREA
* TIME FROM OPERATION AT LEAST 6 MONTHS

Exclusion Criteria:

* penicillin allergy
* pregnancy
* familial history of RF
* Post streptococcal glomerulonephritis
* Background illness-heart, kidney, lungs
* fever \> 38.5c in the op day
* URT Infection
* Family history of PANDAS