cyrilzakka/clinical-trials huggingface dataset:
Effect of Itraconazole on the Pharmacokinetics of BIIB074

The primary objective of the study is to assess the effect of cytochrome P450 (CYP) 3A4 inhibition on the pharmacokinetics (PK) of BIIB074. The secondary objectives of this study are to assess the safety and tolerability of BIIB074 when co-administered with a strong CYP3A4 inhibitor and to assess the effect of CYP3A4 inhibition on the PK of 3 metabolites of BIIB074 (CNV3000497 \[M13\], CNV2283325 \[M14\], and CNV2288584 \[M16\]).


Eligibility Criteria:
Key Inclusion Criteria:

* Body mass index of 18 to 29 kg/m2, inclusive, with body weight ≥50 kg for males and ≥45 kg for females.
* Male or postmenopausal or surgically sterile females.
* Must be in good health as determined by the Investigator (or designee), based on medical history and screening evaluations.

Key Exclusion Criteria:

* Females of childbearing potential.
* Other unspecified reasons that, in the opinion of the Investigator or Sponsor, make the subject unsuitable for enrollment.

NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
Use of Botulinum Toxin A in Direct Eyebrow Lift Scar

Prospective, controlled and randomized study in which participants indicated for surgery to direct eyebrow lift will be randomized into two groups. In addition to surgery, the patients will be treated with botulinum toxin in one eyebrow and saline (placebo) in the other site. The patients participate as treatment and placebo at the same time. Assessments will be carried out through non-invasive exams.

A component of eyebrow ptosis, part of the natural aging process, with or without asymmetries, is found in the majority of patients who seek the blepharoplasty procedure.

There are several procedures to address this condition, but none of them is undoubtedly superior to the others. The direct eyebrow lift technique is known for providing good eyebrow suspension, predictable results and relatively low complexity surgery, which can be performed with local anesthesia.

However, the biggest concern for surgeons and patients is the final appearance of the scar, which will be in a visible area of the face. Botulinum toxin A has been used in recent studies precisely to improve the appearance of scars. Previous studies mainly evaluated traumatic lacerations and post-tumor excision reconstructions, obtaining positive results, with an improvement in the appearance of the wounds in patients who used the medication. It is a safe drug, used for several years for other purposes and without serious adverse effects according to these studies.

The objective of this study is to compare the use of botulinum toxin A versus 0.9% saline solution in the healing of direct eyebrow lift surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age with indication for direct eyebrow lift surgery.

Exclusion Criteria:

* Vulnerable groups: children, pregnant women and immunosuppressed patients
* Allergy to botulinum toxin A
* Patients under 18 years old
* Women who are breastfeeding
* Patients with muscular/neuromuscular diseases such as myasthenia gravis and amyotrophic lateral sclerosis
* Patients who underwent botulinum toxin A injection in the last 6 months prior to surgery
* Patients with a history of radiotherapy, chemotherapy or hematological disorders
* Refusal to participate in the study
What Concept of Manual Therapy is More Effective?

The aim of the study will be to find out which manual therapy approach is most effective for the improvement of symptoms (sensory, cognitive, emotional and social) in people with Fibromyalgia.

A randomized clinical trial will be conducted in 52 patients with Fibromyalgia who will undergo a myofascial treatment approach or a passive mobilization treatment approach. Data will be collected on the improvement of symptom severity, quality of life, self-efficacy, kinesiophobia, catastrophizing, central sensitization, anxiety, depression, and sleep. After the treatments, follow-ups will be made, and the results are expected to be disseminated to the scientific community during and after the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* Less than 62 years old
* Medical Diagnosis of Fibromyalgia
* The individuals included in the study had a minimum one-year history of symptoms
* To confirm the medical diagnosis of fibromyalgia, the physical therapists and study investigators used the 2010 American College of Rheumatology (ACR) diagnostic criteria. -Since 2 of the measurement variables used in the study (WPI and SS-Score) match the protocol when determining these criteria, this procedure was facilitated.

The diagnostic criteria establish the diagnosis of fibromyalgia when12 : IDG/WPI ≥ 7 and SS ≥ 5 or IDG/WPI 4-6 and SS ≥ 9.

Exclusion Criteria:

* Intolerance to touch
* A change of medication in the last 2-3 months
* Agree not to change their medication during the study

Exclusion Criteria:

-
Evaluation of Safety of Acellular Dermal Matrix(ADM) in Breast Reconstruction

The goal of this observational study is to evaluate the safety of Acellular Dermal Matrix(ADM) processed by CO2 supercritical fluid technology against other acellular dermal matrix products from different companies that have been washed with detergents in patients undergoing breast reconstruction surgery with implants due to the breast cancer.

Outline:

The total number of study subjects is 120, with 60 people recruited prospectively into the test group and 60 people retrospectively into the control group.

The test group will receive SC Derm Recon(ADM processed by CO2 supercritical fluid technology) during the implant-based breast reconstruction surgery.

The control group will be retrospectively and consecutively selected from medical records of patients who underwent implant breast reconstruction using ADM from other companies between March 1, 2021, and March 31, 2024.

After surgery, patients will be followed up at 2 weeks, 4 weeks, and 12 weeks.

Primary Objectives

I. To assess whether the test group with applying the ADM processed by the supercritical fluid technology will have less short-term major complications than the control group with the ADM processed by detergents.

Eligibility Criteria:
Inclusion Criteria:

1. Prospective subjects (Test group) 1) Adult women aged 19 to 79 years. 2) Patients who received SC DERM® Recon, an acellular dermal matrix product, during breast reconstruction surgery with implants following a mastectomy due to breast cancer. 3) Individuals who have voluntarily provided written informed consent after receiving an explanation of the study's purpose and methods, are willing to comply with the study protocol, and are willing to visit the hospital for the evaluation of observational parameters.
2. Retrospective Medical Record Collection 1) Patients who received an acellular dermal matrix product during breast reconstruction surgery with implants following a mastectomy due to breast cancer at Seoul National University Hospital between March 1, 2021, and March 31, 2024.

Exclusion Criteria:

1. Prospective subjects (Test group) 1) Individuals deemed inappropriate for study participation by the principal investigator or other investigator's judgement. (e.g., those unable to undergo the required tests for this study).
2. Retrospective Medical Record Collection 1) Patients who received an acellular dermal matrix product but have no recorded follow-up visits after application.
Effect of Dexmedetomidine on Bispectral Index and Propofol Requirements During Different Menstrual Cycle

The study was done to evaluate the effects of the follicular and luteal phases of the menstrual cycle on sedation level at loss of consciousness and bispectral index reach to 50 during propofol anesthesia, in patients with and without preoperative intravenous dexmedetomidine .


Eligibility Criteria:
Inclusion Criteria:

* a regular menstrual cycle
* elective gynecologic surgery

Exclusion Criteria:

* pregnancy
* breastfeeding
* obesity
* known hypersensitivity to drugs used in the study protocol;
* use of psychotropic drugs and steroids within 72 hours before the surgery
* central nervous system injury
* renal impairment
* alcoholism and opioid addiction.
External DCR Versus Canalicular SI With MMC in NLDO

While external DCR is the gold standard procedure for primary NLDO as well as complicated cases, SI with MMC could achieve comparable success rates in primary acquired NLDO, hence should be considered as an alternative as a safe and minimally invasive procedure.

Purpose: To compare external dacryocystorhinostomy versus canalicular silicone intubation with the use of Mitomycin C (MMC) in primary acquired nasolacrimal duct obstruction (NLDO).

Methods: the study was carried out at the department of Ophthalmology, Menoufia university Hospital, Egypt, between June 2012 to July 2014. Fifty-six patients who were diagnosed with primary acquired NLDO. Patients were randomly allocated into two groups: thirty cases underwent external DCR and twenty-six cases underwent silicone intubation with MMC.

Eligibility Criteria:
Inclusion Criteria:

* primary acquired NLDO

Exclusion Criteria:

* All other secondary causes of NLDO
Peptide Vaccination in Treating Patients With Esophageal Cancer (STF-II)

The purpose of this study is to evaluate overall survival and immunological monitoring for peptide vaccination therapy using novel cancer testis antigens (STF-II) for locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma

The phase II multicenter trial of vaccination study using peptides derived from URLC10, CDCA1, and KOC1 for locally advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) who had failed for the standard therapy are performed to evaluate the survival benefit of the cancer vaccination.

Eligibility Criteria:
Inclusion Criteria:

DISEASE CHARACTERISTICS

1. Locally advanced, recurrent or metastatic esophageal squamous cell carcinoma who had failed for the standard therapy

PATIENTS CHARACTERISTICS

1. ECOG performance status 0-2
2. Age≧20 years, 80≦years
3. WBC≥ 2,000/mm³ Platelet count ≥ 75,000/mm³ Total bilirubin ≤ 2.0 x the institutional normal upper limits AST, ALT, ALP ≤ 2.5 x the institutional normal upper limits Creatinine ≤ 1.5 x the institutional normal upper limits
4. No therapy 4 weeks prior to the initiation of the trial
5. Able and willing to give valid written informed consent -

Exclusion Criteria:

1. Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception)
2. Breastfeeding
3. Serious bleeding disorder
4. Serious infections requiring antibiotics
5. Concomitant treatment with steroids or immunosuppressing agent
6. Decision of unsuitableness by principal investigator or physician-in-charge -
Hemodynamic Optimization During Single Kidney Transplantation With MostcareUP

There are currently no clear recommendations on hemodynamic targets during kidney transplantation and most anesthesiologists rely on empiric or obsolete parameters such as CVP.

The aim of this study is to investigate hemodynamic management of these patients applying a new generation of advanced monitoring systems such as MOSTCAREUP which can potentially provide a clear overview of the circulatory status beat by beat and to adjust fluid therapy in every single patient or clinical condition.

Renal transplantation is actually considered the optimal elective treatment for end stage kidney disease.

Successful renal transplantation involves the optimization of several parameters. Previous studies have suggested that perioperative hemodynamic factors influence immediate and long-term graft survival.

Perioperative hemodynamic management of this kind of surgery is nowadays focused on optimization of fluid therapy concerning both the donor and the graft and their interaction. Postoperative graft function is not exclusively determined by donor and graft characteristics. Several studies over the last 30 years indeed demonstrated that hemodynamic status of the recipient during kidney transplant surgery relates to graft function and proper management of balancing fluid plays a critical role through maintaining optimal blood volume and so assure an adequate supply of oxygen to the tissues.

Aggressive expansion of the intravascular volume during transplantation surgery has been recommended by most previous studies supporting the so called "liberal" approach to fluid management suggesting that a massive intravascular volume expansion was necessary improve renal blood flow and minimize hypoperfusion caused tissue damages. Nowadays it is clear that adequate early graft function requires perfusion of the transplanted kidney, which may be enhanced by expansion of the intravascular volume in the recipient. However, some studies have reported that aggressive intraoperative volume expansion is not always warranted in kidney transplantation and can expose patients with preexistent cardiac disease or poor myocardial function to the risk of fluid overload, acute respiratory failure, and prolonged ventilation. Moreover fluid overload has been demonstrated to be harmful even for graft perfusion, microcirculation and tissue oxygen delivery.

There are currently no clear recommendations on hemodynamic targets during kidney transplantation and most anesthesiologists rely on empiric or obsolete parameters such as CVP.

The aim of this study is to investigate hemodynamic management of these patients applying a new generation of advanced monitoring systems such as MOSTCAREUP which can potentially provide a clear overview of the circulatory status beat by beat and to adjust fluid therapy in every single patient or clinical condition.

Eligibility Criteria:
Inclusion Criteria:

Written informed consent Renal transplantation candidate

Exclusion Criteria:

Double kidney transplantation Living donor kidney transplantation Hystory of heart failure
A Study of Itraconazole in the Prevention of Histoplasmosis, a Fungal Infection, in HIV-Infected Patients

To assess the safety and efficacy of itraconazole versus placebo for prevention of histoplasmosis in HIV-infected patients with CD4 counts \< 150 cells/mm3 who reside where histoplasmosis is endemic. To assess the safety and efficacy of itraconazole for preventing other debilitating fungal infections, such as cryptococcosis, aspergillosis, recalcitrant oropharyngeal or vaginal candidiasis, and recurrent esophageal candidiasis.


Eligibility Criteria:
Inclusion Criteria

Patients must have:

* HIV infection.
* Residence in an area endemic for H. capsulatum.
* Absolute CD4 count \< 150 cells/mm3.
* No current or past active histoplasmosis.
* No other active fungal infection.
* Life expectancy of at least 1 year.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Life-threatening infection or malignancy other than cutaneous Kaposi's sarcoma.
* Inability to take oral medication.

Concurrent Medication:

Excluded:

* Systemically-active antifungals.
* Investigational drugs (expanded access drugs are acceptable).
* Rifampin.
* Rifabutin.
* Terfenadine.
* Astemizole.
* Phenobarbital.
* Phenytoin.
* Carbamazepine.
* H2 blockers.
* Omeprazole.
* Continual antacids.

Patients with the following prior conditions are excluded:

History of intolerance to imidazole or azole compounds.

Prior Medication:

Excluded within 1 month prior to study entry:

* Investigational drugs (expanded access drugs are acceptable).

Excluded within 15 days prior to study entry:

* Rifampin.
* Rifabutin.
* Terfenadine.
* Astemizole.
* Phenobarbital.
* Phenytoin.
* Carbamazepine.
The Investigation of Thoracic Spinal Curvature and Mobility in Subjects With and Without Neck Pain: Cut-off Points

The purpose of this study is to investigate the sagittal thoracic spinal curvature and mobility in subjects with and without chronic neck pain, cut-off points and pain relationship


Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 18 and 65 years with persistent neck pain for more than 3 months
* The inclusion criteria for the control group included acceptance to participate in the study, no previous neck pain (lifetime-to-date), no spinal surgery or deformity, and no radiological abnormalities detected

Exclusion Criteria:

* Prior history of injury or surgery relating to spine, spinal deformity, neurological symptoms or signs, radiological abnormalities indicating cervical radiculopathy or myelopathy, prior history of other spinal disorder such as low back pain, active intervention in the last 3 months including drug therapy or physiotherapy, malignancy, systemic pathology including any rheumatologic disease and osteoporosis
Measuring the Concurrent Validity of the Upper Limb Use Ratio With Accelerometers in an Ecological Situation After Stroke.

The purpose of this stufy is to measure the concurrent validity of the upper limb use ratio with accelerometers in an ecological situation after stroke.

The first visit will be used to present the study and potential risks to patients, obtain their consent and collect clinical data. A second visit is planned for the patients who meet the eligibility requirements, to carry out activities in ecological situation.

Eligibility Criteria:
Inclusion Criteria:

* Subject with hemiparesis following stroke
* Subject participating in ecological activities during occupational therapy sessions
* Adult subject aged 18 or over
* Subject informed of study participation and not objecting to participation

Exclusion Criteria:

* Other neurological or musculoskeletal disorders limiting use of upper limbs
* Pregnant or breast-feeding woman,
* Failure to obtain consent,
* Non-affiliation with a social security scheme,
* Persons under court protection,
* Person protected by law (under guardianship or curatorship)
* Participant in another research project with an exclusion period still ongoing.
Safety and Effect of Low-Energy Extracorporeal Shockwave Therapy (ESWT) on the Renal Allograft in Transplant Recipients.

The aim is to investigate the safety and potential effect of Low-energy Shockwave Therapy (ESWT) on the transplanted kidney. The treatment consist of ESWT two times a week for three weeks, six treatments in total.

The hypothesis is that ESWT with improve the renal function, by reducing proteinuria (in a 24-hour urine collection test) and improving renal clearance of 51Cr-EDTA.

The safety of ESWT on the renal allograft will be assessed during and after treatments.


Eligibility Criteria:
Inclusion Criteria:

* Minimum 1 year ago since last kidney transplant
* P-Creatinin under 300, in the last 3 blood-samples
* U-Albumine/creatinine ratio over 100, in the last 3 urine-samples

Exclusion Criteria:

* Not Danish speaking.
* Obstructive uropathy
* Suspected autoimmune disease in the kidney graft
* Symptomatic urinal tract infection (UTI)
* Severe psychiatric disorder
* Pregnant or planning on becoming pregnant
Family Based Interpersonal Psychotherapy (FB-IPT) for Depressed Preadolescents

The investigators proposed a preliminary randomized control trial of Family Based Interpersonal Psychotherapy (FB-IPT), a family-based adaptation of Interpersonal Psychotherapy for Depressed Adolescents (IPT-A; Mufson et al., 2000). Forty-five preadolescent children (ages 8-12) diagnosed with a depressive disorder will be randomized to receive a 14-week course of FB-IPT or Client Centered Therapy (CCT), a supportive nondirective psychotherapy that closely approximates treatment at usual in community mental health clinics. In addition to assessing the feasibility and acceptability of randomization and each of the treatment conditions, this project will evaluate the effects of FB-IPT and CCT across multiple domains, including symptomatology and psychosocial functioning. Preadolescents will be assessed prior to treatment, during treatment (Weeks 3, 7, 11), one week post-treatment, and at 3 and 6 months post-treatment to compare changes in depressive symptoms, global, social, and family functioning. Data on psychosocial risk factors associated with onset and recurrence of preadolescent depression will be collected prior to treatment and at specified intervals post-treatment in order to conduct exploratory analyses on correlates of positive and negative treatment outcomes for Family Based IPT. This data will be used to generate future hypotheses about potential mediators and moderators that will be incorporated into an R01 application for an efficacy study of Family Based IPT.


Eligibility Criteria:
Inclusion Criteria:

* current depressive disorder
* one parent must be willing to participate in treatment

Exclusion Criteria:

* bipolar disorder
* PTSD
* recent abuse
* developmental delay
* autism spectrum disorder
Preoperative Prevalence of Ulnar Neuropathy and Changes in Ulnar Nerve Latency During Surgery

This study is to investigate the incidence of undiagnosed ulnar neuropathy in patients undergoing surgery. The investigators hope to determine if patients with ulnar neuropathy have changes in nerve conduction latency during surgery.

After obtaining an informed consent, the participating subjects will be asked a few questions relating to ulnar nerve dysfunction. Following this the investigators will do a focused physical exam looking for decrement of sensation in the distribution of the ulnar nerve and muscle strength of the hand muscles supplied by the ulnar nerve. After this the subjects will undergo an EMG exam to measure the conduction velocity of the ulnar nerve. Basically the nerve will be stimulated with a small current and the resultant muscle activity of the hand muscle will be picked up using an EKG like patch applied to the skin over the hand. If a subject is diagnosed to have ulnar neuropathy preoperatively the investigators would study the EMG based nerve conduction during surgery at 30-60 minute intervals for the duration of surgery. For purposes of comparison the investigators would measure the ulnar nerve conduction during surgery in age and sex matched controls.

Eligibility Criteria:
Inclusion Criteria:

* 50 yrs of age or older
* Scheduled to undergo a surgical procedure at UTMC with an anticipated length of 2hours or greater

Exclusion Criteria:

* Less than 50yrs
* Not scheduled for a surgical procedure at UTMC or scheduled for a surgical procedure with an anticipated length of less than 2hours
Airway Management and Vascular Access Simulation

This project involves a pre- and post- airway management and vascular access simulation survey. The purpose of the study is to assess the perceived effectiveness of the simulation course on the performance of medical students enrolling in the Anesthesiology rotation during their third and fourth year of medical education.


Eligibility Criteria:
Inclusion Criteria:

* medical student enrolled in the Department of Anesthesiology rotation

Exclusion Criteria:

* anyone not enrolled in the rotation