cyrilzakka/clinical-trials huggingface dataset:
A Study to Assess Safety of Cedirogant and How Cedirogant Moves Through the Body in Adult Participants With Mild, Moderate and Severe Hepatic Impairment

The objective of this study is to evaluate the pharmacokinetics and safety of cedirogant following oral administration of multiple doses in adult participants with hepatic impairment and normal hepatic function.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) is ≥ 18.0 to \< 40 kg/m2
* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile (except liver function tests for subjects with hepatic impairment), and 12-lead ECG

Exclusion Criteria:

* Clinically relevant abnormal medical history, abnormal findings on physical examination, vital signs, ECG, or laboratory tests (except liver function tests for subjects with hepatic impairment) at screening that is assessed as likely to interfere with the objectives of the trial or the safety of the subject.
* History or evidence of active TB or latent TB infection
* Evidence of dysplasia or history of malignancy (including lymphoma and leukemia) other than successfully treated non-metastatic cutaneous squamous cell, basal cell carcinoma or localized carcinoma in situ of cervix
Three miRNA Signatures in Glioma: From Molecular Mechanisms to Potential Clinical Application

Individual overexpression of the three miRNAs negatively affects cell viability and proliferation mainly in grade III IDH-wild type cells, while in higher grade cells, the effect is more pronounced when the entire signature is overexpressed, individual and combined overexpression of the signature members is able to determine a significant reduction in both migration and invasion. Therefore, ectopic expression of the miRNAs identified by us has a negative impact on cell viability, proliferation and apoptosis, but above all on migration and invasion.

Decipher the impact and functional role of the signature formed by miR-1-3p, miR-26a-1-3p and miR-487b-3p on glioma biology. The functional role of the miRNAs of the signature will be assessed with gain/loss of function strategies, using primary glioma cells derived from patients with native IDH-wild type or mutated status. To set up the system we will start the study using glioma cell lines derived from patients already well characterized from a molecular and immunohistochemical point of view following the criteria reported by the new update of the 2016 WHO classification of tumors of the central nervous system. Furthermore, the involvement of the signature in the response to treatment will be evaluated. Despite the application of the most recent treatment protocols, the prognosis of patients with glioma remains unfavorable especially for patients with grade 4 glioma IDH-wild type in which resistance to radiotherapy and temozolamide contributes significantly to the negative outcome. Since it has been reported that some miRNAs can promote chemosensitization on a wide variety of tumors, including gliomas, the involvement of the miRNA signature in the response to treatment of these tumors will be studied. Cellular sensitivity to radiotherapy and temozolamide will be evaluated by dose-response curves in cell lines and primary cells derived from both IDH-wild type and IDH-mutated patients.

Eligibility Criteria:
Inclusion Criteria:

* histological diagnosis of glioma;
* no concomitant primary tumor;
* no metastatic disease;
* availability of surgical material/tissue;
* written informed consent.

Exclusion Criteria:

* histological diagnosis of non-glial tumor;
* patients with concomitant other solid tumors;
* metastatic disease;
* no surgical material/tissue available;
* HIV seropositivity.
A Phase 1 Study Of Talazoparib, PARP Inhibitor, In Japanese Patients With Advanced Solid Tumors

This is a Phase 1 study which consists of 2 parts; Dose Escalation part and Expansion part.

The dose escalation part is open-label, and evaluates safety, preliminary efficacy and PK of single-agent talazoparib in sequential cohorts of adult patients with advanced solid tumors who are resistant to standard therapy or for whom no standard therapy is available.

In the dose escalation part, up to 18 (minimum 3) patients are expected to be enrolled depending on the observed DLTs.

The expansion part is designed to assess the efficacy, safety and PK of single-agent talazoparib at RP2D determined in the dose escalation part in adult patients with locally advanced or metastatic breast cancer who have deleterious or suspected deleterious germline BRCA1 or BRCA2 mutations.

In the expansion part, a minimum of 17 patients will be enrolled evaluable for the primary endpoint.


Eligibility Criteria:
\[Dose Escalation Part\]

Inclusion Criteria:

* Histological or cytological diagnosis of locally advanced or metastatic solid tumor that is resistant to standard therapy or for which no standard therapy is available.
* ECOG Performance Status 0 or 1.
* Adequate Bone Marrow, Renal and Liver Function.

Exclusion Criteria:

* Patients with known symptomatic brain metastases requiring steroids.
* Current use of a strong P-gp inhibitor, strong P-gp inducer, or strong inhibitor of BCRP within 1 week or 5 half lives which ever is longer prior to the first dose of study treatment.
* Fertile male patients and female patients of childbearing potential who are unwilling or unable to use 2 highly effective methods of contraception.

\[Dose Expansion Part\]

Inclusion Criteria:

* Histologically or cytologically confirmed carcinoma of the breast.
* Locally advanced breast cancer that is not amenable to curative radiation or surgery and/or metastatic disease.
* Documentation of a deleterious, suspected deleterious, or pathogenic germline BRCA1 or BRCA2 mutation by Myriad Genetics' BRACAnalysis CDx test.
* No more than 3 prior chemotherapy-inclusive regimens for locally advanced or metastatic disease.
* Have measurable lesion by the RECIST v.1.1.
* ECOG Performance Status 0-2.
* Adequate Bone Marrow, Renal and Liver Function.

Exclusion Criteria:

* First-line locally advanced or metastatic breast cancer with no prior neoadjuvant and adjuvant chemotherapy.
* Prior treatment with a PARP inhibitor.
* Objective disease progression while receiving platinum chemotherapy administered for locally advanced or metastatic disease.
* HER2 positive breast cancer.
* Active inflammatory breast cancer.
* Central nervous system (CNS) metastases.
* Current or anticipated use within 7 days prior to the first dose of study treatment, or anticipated use during the study of strong P-gp inhibitors.
* Fertile male patients and female patients of childbearing potential who are unwilling or unable to use 2 highly effective methods of contraception.
Use of Diagnostic Dye to Identify Areas of Leakeage,in the Retina, Prior to Receiving Focal Laser Treatment

The use of Indocyanine green diagnostic dye will identify areas of vascular leakage which will provide more effective laser treatment by targeting these specific areas.

The Early Treatment of Diabetic Retinopathy Study showed that early treatment of Clinically Significant Macular Edema (CSME) with focal and grid laser preserved vision in diabetic patients. Indocyanine Green angiography, which was not available at the time of the Early Treatment Diabetic Retinopathy Study (ETDRS), is now standard-of-care for diagnostic evaluation of the choroidal circulation and is routinely done in combination with Fluorescein angiography for a more complete visualization of retinal pathology. Simultaneous examination of both retinal and choroidal circulation allows for identification of microaneurysms that are hyperfluorescent both on Fluorescein angiography and Indocyanine green angiography. Such microaneurysms are sites of increased vascular leakage and represent a means for providing more effective laser treatment by targeting these areas directly with focal laser.

Eligibility Criteria:
Inclusion Criteria:

* Meets criteria for Clinically Significant Macular Edema
* Microaneurysms hyperfluorescent

Exclusion Criteria:

* Increase intraocular pressure
* Intraocular inflammation
* Retinal detachment
Persistence and Long-Term Protection of Vi Antibodies Induced by Vi-DT Conjugate Vaccines in Indonesian

Vi-DT Typhoid vaccine is a novel vaccine. This study will be done to know the long-term protection and persistent antibody by measured the antibody titer after 2,3,4 and 5 years after immunization.

This study will be done to know the long-term protection and persistent antibody, by measured the antibody titer after 2,3,4 and 5 years after immunization.

Eligibility Criteria:
Inclusion Criteria:

* Healthy.
* Subject who completed the phase II Vi-DT study (Typhoid 0218)
* Subjects/Parents have been informed properly regarding the study and signed the informed consent form.
* Subject/parents/legal guardians will commit to comply with the instructions of the investigator and the schedule of the trial.

Exclusion Criteria:

* Subject concomitantly enrolled or scheduled to be enrolled in another trial.
* Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature ≥ 37.5oC).
* Known history of allergy to any component of the vaccines.
* History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.
* Any abnormality or chronic disease which according to the investigator might be compromised by the vaccination and/or interfere with the assessment of the trial objectives.
Epidemiology of Hepatitis B, C and Delta in Reunion Island

Viral hepatitis B, C and Δ represent a global public health problem for which France was very early mobilized. Despite this, in its foreword, the Dhumeaux report on "Management of people infected with hepatitis B or hepatitis C viruses" identifies a residual area of weakness in this care that is the incomplete regional epidemiological data in the Overseas Territories. The specific ethno-socio-cultural characteristics of these territories make it difficult to transpose data from the mainland France. This study aims at improving our knowledge on the characteristics of patients with hepatitis B, C and Δ in Reunion Island, their follow-up, their evolution and complications.


Eligibility Criteria:
Inclusion Criteria:

Major patient

* with confirmed HBsAg and / or anti HCV positive Ab
* residing in Reunion Island
* followed in one of the participating centers

Exclusion Criteria:

• Patient carrying isolated anti HBc antibodies
Ev-AIFIB Preliminary Evaluation of the AIFib Software

To evaluate the intraoperative effectiveness of the AIFIB software in real time in the detection of atrial fibrillation drivers during an ablation procedure.


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years of age or older
* Etiology in the following list:
* Atrial fibrillation for which a conventional anatomical approach alone (pulmonary vein isolation) is not performed: persistent AF, long standing persistent AF paroxysmal AF (redo), paroxysmal AF
* Atrial tachycardia de novo or secondary to AF ablation.

Exclusion Criteria:

* Contraindication to AF ablation
* Major bleeding disorder
The Effect of Emotional Freedom Techniques on Pelvic Pain

Pelvic pain caused by endometriosis is a common symptom and reduces women's quality of life.

EFT is a method that can be preferred in pelvic pain due to its ease of use and low cost.

Raising women's awareness for EFT

Pelvic pain caused by endometriosis is a common symptom and reduces women's quality of life. EFT has become widely used in medical and psychological treatment settings in recent years.It is also used as a self-help technique by millions of people every year.EFT is a method that can be preferred in pelvic pain due to its ease of use and low cost.

Eligibility Criteria:
Inclusion Criteria:

1. Being diagnosed with endometriosis
2. Experiencing pelvic pain
3. Being between the ages of 18-49
4. Those whose symptom complaints are 5 or above on the visual analogue scale

Exclusion Criteria:

1. Patients with known systemic diseases (e.g. hypertension, diabetes, coronary, kidney and liver diseases);
2. Patients with known malignancy;
3. Women in menopause;
4. Having any obstacle to communication
Comparing Effect of Opioid-sparing Versus Conventional Anesthesia on Quality of Recovery After Emergency Laparotomy

Aim of the Work The investigators aim to compare lidocaine-based anesthesia versus conventional anesthesia in the presence of multimodal analgesia protocol in terms of early quality of recovery and analgesic efficacy.

Objectives To compare quality of recovery using the Quality of recovery-15 (QoR-15) score between lidocaine-based anesthesia in relation to conventional anesthesia in patients undergoing emergency laparotomy.

Hypothesis the investigators hypothesize that lidocaine-based regimen would be effective in reducing opioid use and provide superior quality of recovery compared to conventional opioid-routine anesthesia in emergency laparotomy.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (18-65 years)
* ASA I-III undergoing emergency laparotomy with midline incision.

Exclusion Criteria:

* Severe cardiac morbidities (impaired contractility with ejection fraction \< 45%, heart block, arrhythmias, tight valvular lesions) and patients on beta-blockers
* Patients on vasopressor infusion, patients with high shock index (heart rate / systolic blood pressure \>1)
* Body mass index \<18 or \> 35 Kg/m2,

  * Pregnant or lactating women,
Dynasplint Therapy for Trismus in Head and Neck Cancer

The purpose of this study is to compare the use of the Dynasplint Trismus System to routine trismus treatment in improving the ability of opening the mouth in a randomized trial. This study will also determine what effects, good and/or bad, this procedure has on the participant. Participants will be randomly assigned to the Dynasplint Trismus System or to routine treatment with tongue depressors.

This trial is a single-institution, randomized study to evaluate the effectiveness of the Dynasplint Trismus System (DTS) for patients with trismus. Improvement of mouth opening and quality of life of participants using DTS will be compared to improvement of mouth opening and quality of life of participants using standard therapy. Standard therapy will be the use of tongue depressors. Crossover from standard therapy to DTS will be implemented if at three months there is no improvement in mouth opening when using tongue depressors.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with \<= 30mm mouth opening who have undergone treatment for head and neck cancer. (If the patient is edentulous then mouth opening must be \<= 40mm.)
2. Patients who are receiving or have completed treatment for head and neck cancer (surgery, radiation, chemotherapy alone or in any combination).
3. Patients must be completely recovered from any radiation induced oral mucositis.
4. Age =\>19 years.
5. Patients must sign informed consent.

Exclusion Criteria:

1. Severe periodontal or gum disease that has caused teeth to be loose.
2. Any systemic disease that causes blistering of the oral mucosa.
3. Any condition that renders the patient unable to understand the informed consent.
4. Participants who are not able to comply with protocol activities.
The Effect of Frequent Self Measurements of Blood Pressure on the Control of Hypertension

Despite knowledge regarding the importance of controlling patients' blood pressure (BP) only 30% of treated patients achieve BP goals. Our objective was to determine the effect of frequent self measurements of BP in the patients' natural environment as a mean to improve BP control. Our hypothesis was that frequent measurements of BP will reduce mean BP levels.


Eligibility Criteria:
Inclusion Criteria:

* Signing an informed consent form
* Having a diagnosis of hypertension for more than one year according to patients'records.
* receiving at least one medication for hypertension
* A reasonable understanding of Hebrew
* An ambulatory state enabling regular visits to a primary physician in the community and self-measurement of hypertension using the electronic device

Exclusion Criteria:

* Lack of willingness to participate in the study.Known arrhythmia
* Malignant disease
* Poor understanding of Hebrew
Presence and Comparison of Sarcopenia in Early Rheumatoid Arthritis and Rheumatoid Arthritis

introduction: In this study, the presence of sarcopenia in cases with early rheumatoid arthritis and established rheumatoid arthritis will be compared.

Materials and Method: According to the power analysis, 24 patients with early rheumatoid arthritis and 24 patients with established rheumatoid arthritis who meet the 2010 American College of Rheumatology (ACR) / European Alliance of Associations for Rheumatology (EULAR) rheumatoid arthritis (RA) classification criteria will be included in the study.

According to the power analysis, 24 patients with early rheumatoid arthritis and 24 patients with established rheumatoid arthritis who met the 2010 ACR / EULAR RA classification criteria will be included in the study. The presence of sarcopenia will be evaluated according to the European Working Group on Sarcopenia in Older People (EWGSOP-2) criteria by performing hand grip strength, muscle mass measurement with Bioelectrical Impedance Analysis (BIA), and 4-meter general walking speed tests. Demographic data of the patients and anti-nuclear antibody (ANA), rheumatoid factor (RF) and anti-cyclic citrullinated peptide (anti-CCP) levels, Simplified Disease Activity Index (SDAI), Clinical Disease Activity Index (CDAI), Disease Activity Score ( DAS)28, functional status (health assessment questionnaire (HAQ)), quality of life (RA quality of life scale (RAQoL)), anxiety and depression (hospital anxiety and depression scale (HADS)) results will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria for the early RA group:

* To be diagnosed with RA according to the 2010 ACR (American Society for the Study of Rheumatism) / EULAR (European Association for the Study of Rheumatism) RA classification criteria
* Being 18 years or older
* Being followed up with a diagnosis of RA for less than 1 year (early RA)

Inclusion criteria for the RA group:

* To be diagnosed with RA according to the 2010 ACR (American Society for the Study of Rheumatism) / EULAR (European Association for the Study of Rheumatism) RA classification criteria
* Being 18 years or older

Exclusion Criteria:

* Presence of other rheumatic disease
* Presence of malnutrition
* Recent surgical history,
* Stroke history,
* Pregnancy,
* Presence of prosthesis or metal implant,
* Presence of a pacemaker,
* Patients over 140 kg
Acupuncture Treatment for Vertebral Compression Fracture

Patients with vertebral compression fractures (VCF) may experience pain, limitation of daily activities, and various complications (e.g., insomnia, constipation, urinary infection, depression, diminished quality of life).

Objective:

This study aims to evaluate the effectiveness, safety and feasibility of acupuncture treatments to achieve pain relief and functional recovery in patients with VCF.

Patients who have subacute or chronic vertebral compression fracture in one or more thoracic/lumbar vertebral body are eligible. Patients who have willingness to participate and provide written informed consents will be treated to the Pusan National University Korean Medicine Hospital with once to three times per weak for six weeks approximately. (total 12-18 sessions)

Eligibility Criteria:
Inclusion Criteria:

* Is at least 19 years of age
* Radiographic confirmation of one more subacute or chronic stable vertebral compression fractures (x-ray, computerized tomography, or magnetic resonance imaging)
* Patient-reported pain intensity equal or greater than 4 points on 0 to 10 VAS scale at baseline
* Willingness to participate in the study and provide written informed consent
* Is able to give written consent independently or with a supporter's help

Exclusion Criteria:

* Pathological fracture (malignancy, myeloma, metabolic disease, etc.)
* Spine malformation
* Pregnancy, infection, impaired cognitive function
* Hypersensitive reaction to acupuncture treatment
* Need for surgical treatment

  1. Neurologic deficit: spinal cord injury, cauda equina syndrome
  2. Unstable fracture: three-column collapse, burst fracture, posterior ligament rupture, distraction fracture
  3. Scoliotic angle ≥ 12°
Effects of the Face Mask on Physical Fitness in Children

The aim of this multicenter randomized crossover design study is to evaluate a sample of 500 boys and girls from public and private schools in the Principality of Asturias, aged between 6 and 12 years, with the objective of determining the level of physical condition, as well as to evaluate the effect of the use of FFP2/N95 face masks during the execution of the ALPHA Fitness battery, and the emotional effects caused by the use of these masks. This is a sample obtained by accessibility, in which the sampling will be stratified by age and academic year.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 6 and 12 years old.
2. Be able to perform all the tests and procedures that comprise the study.
3. Have signed informed parental consent.

Exclusion Criteria:

1. To take drugs that can affect the measurements
2. Contraindications or pathologies associated with exercise
PEP005 Gel - Evaluation of Local Tolerability After Exposure to Ingenol Mebutate Gel Followed by Hand Washing in Healthy Subjects

The purpose of this phase 1 trial is to investigate the local tolerability on the finger following exposure to PEP005 Gel 0.015% or 0.05% and hand washing once daily, for 2 or 3 consecutive days.


Eligibility Criteria:
Inclusion Criteria:

* Must be male or female and at least 18 years of age
* Female patients must be of: non-childbearing potential or if of childbearing potential then have a negative serum and urine pregnancy test and using effective contraception
* Ability to provide informed consent

Exclusion Criteria:

* Have received treatment with immunomodulators, or interferon/interferon inducers or systematic medications that suppress the immune system in the last 4 weeks
* Exposed to prescribed systemic (take as tablet, injection etc) or topical (gel, cream, lotion) medication within the last 7 days
* Have any signs of skin irritation or damaged skin at or around the dominant index finger
* Have worked in an occupation with a high risk of being in contact with irritative material (eg. chemicals, painting) on their hands, especially fingers
* Those who are currently participating in any other clinical trial
* Those known or suspected of not being able to comply with the requirements of the protocol
* Females who are pregnant or are breastfeeding