cyrilzakka/clinical-trials huggingface dataset:
DDI Study of ASC41 in HV and the PK, Safety and Tolerability in Subjects With NAFLD.

The primary objective of this study is to evaluate the effect of itraconazole, a strong inhibitor)of cytochrome P4503A , and phenytoin a strong inducer of cytochrome P450 3A, CYP3A4, CYP1A2 and CYP2C19 on the pharmacokinetics of ASC41, a THR beta agonist tables in healthy subjects. The PK, Safety and Tolerability of ASC 41 in Subjects with NAFLD will also be evaluated. Approximately 24 subjects including 16 healthy volunteers (HVs) and 8 subjects with NAFLD will be enrolled. This study consists of 3 cohorts.

This multiarm study in HVs and subjects with NAFLD is designed to further characterize the PK, safety and tolerability of ASC41. Part I of the study will assess the effect of itraconazole and phenytoin on the single-dose PK of ASC41 in HVs. Part II of the study will evaluate the PK, safety and tolerability of a single dose of ASC41 in subjects with NAFLD. The pharmacokinetics of ASC41 and its metabolite ASC41-A will be assessed in both parts I and II. The secondary objective of the study is to characterize the safety and tolerability of oral ASC41 in subjects in the U.S. with NAFLD and in HVs. Approximately 24 male and female participants will be enrolled. This study consists of 3 cohorts.

Eligibility Criteria:
Key Inclusion Criteria:

* Part I Healthy subjects between 18 to 55 years of age
* Part II

  1. Subjects with NAFLD
  2. Subjects between 18 to 65 years of age

Key Exclusion criteria:

* Part I

  1. A history of thyroid disease
  2. A history of, or current liver disease, or liver injuries
  3. Platelet count \<150,000/mcL
  4. INR\> 1.2
  5. History of, or current electrocardiogram (ECG) abnormalities, arrhythmias or heart valve diseases judged to be clinically significant by the investigator
* Part II

  1. A history of thyroid disease
  2. Current or history of cirrhosis or decompensated liver disease
  3. AST or ALT \> 5X ULN
  4. DBIL \> ULN
  5. Acute or chronic liver disease other than NAFLD
  6. A history of bariatric surgery
  7. HbA1c \>9.5% at screening
  8. Testosterone or estrogen replacement therapy
  9. Inducers or inhibitors of CYP3A4, including herbal therapies such as St John's Wort (CYP3A4 Inducer)
Comparing Advanced Hemostasis and Ultrasound-Guided Puncture to Conventional Approaches in Distal Radial Access

Meta-analysis results show that distal radial access (DRA) is associated with a significant reduction in the risk of radial artery occlusion compared to conventional transradial access (TRA). This is of paramount importance in an evolving interventional context where an increasing number of radial access procedures are being performed to address a growing number of independent health conditions. DRA is also associated with a lower rate of vascular access-related adverse events, establishing it as the safest vascular access ever.

However, available data show that the success rate of DRA is lower than that of conventional TRA. Also, while the duration of hemostasis has been shown to be shorter, it has most likely not yet reached its full potential for shortening. Thus, the two extreme phases of DRA require important further evaluation.

The CompAring uLtrasound-guided Puncture and advanced HemostAsis to cOnventional approaches in distal radial access: a dual randoMizEd praGmatic triAl (ALPHA\&OMEGA) trial will address this lack of knowledge by exploring whether a significantly shorter hemostasis duration can be achieved with DRA when using hemostasis enhancement and exploring whether ultrasound-guided puncture can increase the success rate of DRA.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years.
* Patients presenting with CCS or ACS, including unstable angina or NSTEMI.
* Patients planned for coronary angiography or PCI.
* Patients able to provide written informed consent.
* Patient is willing to comply with all study protocol required evaluations.
* Palpable radial pulse both at conventional and distal puncture site.
* Reverse modified Barbeau test confirming radial artery patency in patients with a history of previous radial artery catheterization.

Exclusion Criteria:

* Acute ST-segment elevation myocardial infarction.
* Cardiogenic shock.
* Chronic hemodialysis.
* Contraindications to radial access, such as occlusive upper arm peripheral artery disease, or known anatomic variants prohibiting TRA on both sides.
* Medical conditions that may cause non-compliance with the study protocol and/or may confound the data interpretation.
* Patients unable to provide written informed consent.
Evaluation of the Safety and Efficacy of Titanium-nitric Oxide-coated Stent (Optimax®) in Patients With Lesions With a Low Risk of Restenosis (Diameter ≥ 3.0 mm and Length ≤ 20 mm)

This prospective registry is intended to evaluate the safety and efficacy of the Optimax® stent.

This prospective registry is intended to evaluate the safety and efficacy of the Optimax® stent in de novo coronary lesions with reference diameter ≥ 3.0 mm and Length ≤ 20 mm.

Eligibility Criteria:
Inclusion Criteria:

* Patients with age ≥ 18 years old.
* Patients with de novo coronary lesion treated with Optimax® stent, reference diameter = 3.0 mm and length ≤ 20 mm.
* Informed consent signed.

Exclusion Criteria:

* Refusal of the patient to participate at the study.
* Treatment of other injuries that do not meet the conditions (3x20).
Programmed Death-1(PD-1) Inhibitor Combined With Progesterone Treatment in Endometrial Cancer

We want to make a comparison of PD-1 inhibitor combined with progesterone versus progesterone alone in the treatment of early stage endometrial cancer patients who want to preserve fertility.

Approximately 63,400 new cases of endometrial cancer are diagnosed annually in China. While the initial treatment for early-stage disease is surgical staging with lymphadenectomy, it is apparently inappropriate for young patients who want to preserve fertility. Currently the standardize treatment for these patients are high-dose progesterone, which will be effective in approximately 40\~70% patients. Mirena have been used recently as a new available treatment option, however, no concrete evidence shows it is more effective than the traditional progesterone treatment.

PD-1 inhibitor has been utilized as a salvage treatment in many cancers including ovarian cancer, cervical cancer, lung cancer, gastric cancer and endometrial cancer. As endometrial cancer showed high microsatellite instability-high/deficient mismatch repair (MSI-H/dMMR) rates, it is assumed to be highly responsive to PD-1 inhibitor treatment. Published clinical trial results showed that PD-1 inhibitor treatment was effective in 6/24 late-stage endometrial cancer patients, with little or mild side effects. Here we want to investigate the efficacy of PD-1 inhibitor combined with progesterone in early stage endometrial cancer patients who want to preserve fertility.

Eligibility Criteria:
Inclusion Criteria:

1. Early endometrial cancer patients (cancer confined in the endometrium, endometrioid histology, G1-2)
2. Patients want to preserve fertility
3. Informed consent acquired
4. Age \<18, \>= 45
5. Eastern Cooperative Oncology Group (ECOG) performance status score \<=1
6. Normal blood routine test
7. Normal hepatic and renal function
8. Normal thyroid function
9. Patients willing to accept three times of hysteroscopy: before treatment, 3 months after treatment, 6 months after treatment.
10. Pregnancy test negative before treatment

Exclusion Criteria:

1. Patients are receiving immune-checkpoint inhibitor therapy
2. Patients need or request to receive other anti-cancer drug treatment such as chemotherapy
3. Patients are allergic to immune-checkpoint inhibitor agents
4. Patients have abnormal blood routine test results or impaired hepatic and renal functions
5. Patients have a history of cardiovascular disease, including severe hypertension, frequent cardiac arrhythmia, history of myocardial infarction
6. Patients have a history of hepatitis B or hepatitis C infection, with detectable virus load
7. Severe obstructive lung disease
8. Autoimmune disease
9. Need to receive daily corticosteroid or other immune-inhibitory agents
10. Active tuberculosis patients
11. Patients have a history of other malignant tumors
12. Patients with acute infectious disease
Study to Evaluate Safety and Immunogenicity of GSK Biologicals' Pandemic Influenza (H1N1) Candidate Vaccine in Children

The purpose of this study is to assess the safety and immunogenicity of two doses of the H1N1 candidate vaccine administered in children aged between 8 and 12 weeks at the time of first vaccination.


Eligibility Criteria:
Inclusion Criteria:

All subjects must satisfy ALL the following criteria at study entry:

* Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LARs) can and will comply with the requirements of the protocol
* Children, male or female, aged between 8 and 12 weeks at the time of first study vaccination.
* Written informed consent obtained from the parent(s)/LAR(s) of the subject.
* Healthy children, as established by medical history and clinical examination when entering the study.
* Parent/LAR with access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user device.
* Born after a gestation period of \>= 36 to \<= 42 weeks.

Exclusion Criteria:

The following criteria should be checked at the time of study entry. If ANY exclusion criterion applies, the subject must not be included in the study:

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period.
* Acute disease at the time of enrolment.
* Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing required).
* History of any neurological disorders or seizures.
* A family history of congenital or hereditary immunodeficiency.
* Receipt of systemic glucocorticoids within one month of study enrolment, or any other cytotoxic or immunosuppressive drug since birth.
* Administration of any vaccines within two weeks before study enrolment.
* Administration of immunoglobulins and/or any blood products since birth or planned administration during the study.
* Previous administration of any H1N1 vaccine, of any seasonal influenza vaccine.
* Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b, and/or Streptococcus pneumoniae with the exception of vaccines where the first dose can be given within the first two weeks of life according to the national recommendations.
* History of intercurrent diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b disease.
* Major congenital defects or serious chronic illness.
* Child in care.
* Any known or suspected allergy to any constituent of the influenza, DTPa-IPV/Hib and pneumococcal study vaccines; a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza, DTPa-IPV/Hib and pneumococcal vaccine.
Observation Versus Post-surgery Radiotherapy After Complete Exeresis in Soft Tissues Members Sarcoma

Soft tissue sarcomas represent less than 1% of malignant tumors in adults and sarcomas members represent 60% of them.

These rare tumors involve complex multidisciplinary care better in centers having expertise.

Loco-regional therapy strategies have evaluated over time for tumors of members leading to propose more often the combination of a large conservative tumor excision with radiotherapy. Results have been demonstrated equivalent to those of an amputation in terms of local control and survival.

The local recurrence rate for sarcomas of the members of any kind after surgery with or without radiotherapy in the literature varies from 10 to 30%.

The main objective is to achieve a low recurrence rate while maintaining the function. The question remains the possibility of an absence of irradiation in selected cases in a de-escalation therapy order.


Eligibility Criteria:
Inclusion Criteria:

* Soft tissue sarcoma members histologically confirmed
* Tumor primitive complete excision with margins greater than or equal to 10 mm in the soft tissue in all directions during the initial surgery.

A sub-centimeter margin is authorized under an anatomic barrier (fascia, fascia, inter-osseous membrane, periosteum), if surgery is R0 a margin sub-centimeter depth is allowed for superficial tumors if the underlying fascia RESECTED is not invaded.

* Primitive tumors without breaking initial tumor and without tumor residue in the systematic recovery in case of incomplete initial excision margins or doubtful
* WHO less than or equal to 2
* Age greater than or equal to 18 years
* Review extension negative (normal chest CT)
* Information and monitoring possible
* Patient affiliated to social security

Exclusion Criteria:

* Previously treated local sarcoma relapse
* Visceral or lymph node metastases
* pre-operative treatment (chemotherapy or radiotherapy)
* PNET, alveolar rhabdomyosarcoma, Darrier-Ferrand sarcoma
* excision margins of less than 10 mm in one direction or doubtful or unspecified, except under an anatomic barrier (fascia, fascia, inter-osseous membrane, periosteum), if surgery is R0 and tumors if the superficial fascia underlying RESECTED is not invaded.
* Break-tumor during the initial surgery, or residual tumor at second surgery
* Chemotherapy
* Delay between surgery R0 margins greater than or equal to 1 cm (initial surgery or recovery) and the start of radiotherapy exceeding 8 weeks
* History of radiation on the Member
* History of cancer (except carcinoma in situ of the cervix and basal cell skin cancer or in complete remission for over 5 years)
* Pregnant Women
* Patients under guardianship or curatorship
Evaluation of rSO2 Between Frontal Lesion Area and Normal Area of Brain by NIRSITX Using NIRS in Acute Ischemic Stroke Patients.

The clinical trial is for acute ischemic stroke patients measuring cerebral oxygen saturation (rSO2) values using pulse oximeter of near-infrared spectroscopy in the frontal lesion area and normal area of brain. The purpose of the clinical trial is to compare differences in cerebral oxygen saturation values, and the efficacy and safety are evaluated through additional exploratory clinical trials.


Eligibility Criteria:
Inclusion Criteria:

* Adults over age 19
* Patients diagnosed with acute ischemic stroke within 7 days of symptom onset
* Patient's condition confirmed to have an acute ischemic stroke and also brain blood vessels condition confirmed through brain imaging such as Brain CT/CTA/CT perfusion and Brain MRI/MRA
* Patients voluntarily agree to participate and scheduled to participate in this clinical trial
* Patients willing to comply with the clinical trial protocol

Exclusion Criteria:

* Patients without brain imaging result
* Patients diagnosed with jaundice (hyperbilirubinemia) with abnormal skin color - Patients who find it difficult to wear medical devices for clinical trial on their foreheads
* Patients who has skull fractures of external shape not maintained normal
* Patients who does not agree to participate in this clinical trial
* Patients who are currently participating in another clinical trial or have participated in another clinical trial within 30 days of the screening date
* Patients who is determined from investigator that participating is inappropriate because it may affect the results of the clinical trial or ethically
Femoral Cartilage Thickness in Knee Osteoarthritis

The aim of the study to investigate the relationship between femoral cartilage thickness in Ultrasonographic evaluation and inflammatory parameters, pain severity and functionality in participants with Knee Osteoarthritis

Aim: The aim of the study is to investigate the relationship between femoral cartilage thickness and inflammatory parameters, pain severity and functionality in participants with Knee Osteoarthritis.

Methods: This study is designed as a prospective, cross-sectional trial. 90 participants aged between 50-65 years with knee osteoarthritis(OA) and at least 50 participants without any symptom for knee OA are included in the study in accordance with the inclusion criteria. Participants' demographic characteristics will be evaluated, and ultrasonographic measurement will be performed for measuring femoral cartilage thickness. Visual Analog scale will be used for pain severity and Western Ontario and McMaster Universities Osteoartrit index (WOMAC) will be used for assessing functionality of the patients. Also hematologic parameters(neutrophils, leucocytes, lymphocytes, platelet, CRP, erythrocyte sedimentation rate) will be evaluated for investigating the inflammation. The relationship between femoral cartilage thickness and inflammatory parameters, pain severity and functionality in knee osteoarthritis will be analysed for both group.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed as knee osteoarthritis
* aged between 50-65 years
* volunteer to participate in the study

Exclusion Criteria:

* limitation of cooperation
* moderate to severe dementia or mental retardation, which may cause limitations in examination, testing and treatment
* refusal to participate in the study
* pprevious total knee prosthesis surgery
* secondary osteoarthritis
A Study to Investigate the Pharmacokinetics of RO7079901 and Meropenem in Participants With a Complicated Urinary Tract Infection

This is a non-randomized, open-label, one-treatment, one group study in participants with complicated urinary tract infection (cUTI) including pyelonephritis to characterize the pharmacokinetics of RO7079901 co-administered with meropenem.


Eligibility Criteria:
Inclusion Criteria:

* Requiring hospitalization for IV antibacterial therapy for the treatment of presumed/confirmed cUTI (including pyelonephritis)
* Clinical signs and/or symptoms of pyelonephritis or a cUTI
* Urine culture taken within the 48 hours (hr) period immediately preceding the first dose of study drug contains greater than (\>)1x10\^5 colony forming units (CFU) per milliliter (CFU/mL) of a gram negative organism
* Negative urine pregnancy test result confirmed by a blood test
* Agreement to remain abstinent or use a contraceptive method

Exclusion Criteria:

* Has a concomitant infection requiring antibacterial therapy, in addition to study drug
* Confirmed fungal urinary tract infection
* Moderate or severe renal impairment, or end-stage renal disease requiring renal replacement therapy or a recipient of a renal transplant
* Documented presence of immunodeficiency, or a severely immunocompromised condition or use of systemic immunosuppressant therapy
* Any rapidly progressing disease or immediately life-threatening illness, or other terminal illness or condition with high risk of mortality meaning that the participant is considered, in the opinion of the Investigator, unlikely to survive the study period
* Urinary tract surgery or clinically significant urogenital trauma in the one week immediately preceding study entry
* Urinary tract infection (UTI) symptoms potentially attributable to another process (sexually transmitted infections or prostatitis)
* Suspected or confirmed perinephric or intra renal abscess
* Complete obstruction of any portion of the urinary tract, or a permanent urinary diversion
* History of epilepsy, brain lesions or other significant neurological disorders
* Use of probenecid within the 7 days before enrollment
* Known history of clinically significant hypersensitivity or severe allergic reaction to meropenem or any other antibiotic
* Any other ongoing condition or disease, or clinically significant abnormalities in laboratory test results that the investigator considers would render the participant unsuitable for the study
* Women who are pregnant, planning to become pregnant, or lactating
* Participation in a clinical study of an investigational drug or device within one month prior to enrollment
* Prior enrollment in this study
Treating Cognitive Deficits in Traumatic Spinal Cord Injury (SCI)

The purpose of this research study is to investigate the effectiveness of a memory retraining program and a processing speed program in a spinal cord injured (SCI) population. The study is designed to research how well different types of techniques can help people with SCI improve in areas where they might have difficulties such as memory or processing speed, (time it takes to process information provided).

The objectives of the currently proposed randomized clinical trial are to (1) apply a treatment protocol for Processing Speed and Learning and memory impairments, well-validated in other neurological populations, to individuals with SCI with objectively observable deficits in these areas and document efficacy on standard neuropsychological testing; (2) assess the effectiveness of the interventions in persons with SCI utilizing global measures of everyday life; (3) evaluate the long-term benefit of treatment. Prior to enrollment in the study protocol, all potential subjects will undergo a 2-part screening: (1) an initial screening examination via telephone during which basic information will be gathered and (2) a detailed, in-person screening that will be completed on if the subject passes the initial screen. Individuals must meet full screening criteria to be eligible for participation.

Eligibility Criteria:
Inclusion Criteria:

* I am between the ages of 18 and 75 years old.
* I have a spinal cord injury with the level of injury between C1-T12.
* I am non-ambulatory (I use a wheelchair as my primary means of getting around).
* I have an AIS grade of A, B or C as determined by study staff examination.
* My injury occurred at least 1 year ago.
* My primary language is English.

Exclusion Criteria:

* I have a current illness or infection. My enrollment in this study can be delayed until my current illness or infection is successfully treated.
* I have any neurological condition other than SCI (Alzheimer's disease, dementia, stroke, multiple sclerosis, Parkinson's disease, etc.).
* I have a diagnosis of a psychiatric disorder such as post-traumatic stress disorder, schizophrenia or bipolar disorder.
* I have a history of Hypertension or Diabetes Mellitus (due to its impact on brain function).
* My vision is impaired- more than 20/60 in worst eye (with prescription eyewear).
* I have been taking steroids, benzodiazepines, or certain neuroleptics within past month, the study doctor will review my medications with me.