cyrilzakka/clinical-trials huggingface dataset:
HAIC Combined With Durvalumab and Tremelimumab and Lenvatinib in uHCC

The treatment options for unresectable HCC have rapidly developed, and immunotherapy has shown significant survival benefits in hepatocellular carcinoma. The STRIDE regimen of Single Tremelimumab (high, priming 300-mg dose) Regular Interval Durvalumab (1500 mg every 4 weeks) improved OS vs sorafenib in pts with unresectable HCC. In Asian region, HAIC is applied for HCC patients who are not suitable for surgical resection or local ablation treatment. Retrospective studies suggested a potent antitumor effect and survival benefit of HAIC plus programmed death-1 inhibitor and Lenvatinib. This phase II study was aimed to evaluate the efficacy and safety of STRIDE plus lenvatinib, given concurrently with HAIC in pts with unresectable HCC.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 \~ 70 years old (including 70 years old), male and female;
2. Patients with hepatohcellular carcinoma diagnosed clinically or confirmed by histology / cytology ;
3. Patients with unresectable or metastatic hepatocellular carcinoma;
4. No systematic treatment. Patients recieved previously systematic treatment and progressed can also be included in the group;
5. Patients who underwent hepatectomy in the past should be R0 resection, and the tumor recurrence should be more than 6 months after operation;
6. At least one assessable lesion (mRECIST criteria);
7. Expected survival time ≥ 3 months;
8. ECOG 0 \~ 1;
9. Child Pugh ≤ 7;
10. Be able to cooperate to observe adverse events;
11. Major organs are functioning normally:

    * Hemoglobin ≥ 90 g / L;
    * ANC ≥ 1.5 × 109/L；
    * Platelet count ≥ 75 × 109/L；
    * Albumin ≥ 28 g / L;
    * Total bilirubin ≤ 2 × ULN;
    * AST, ALT ≤ 5 × ULN；
    * ALP ≤ 5 × ULN；
    * Creatinine ≤ 1.5 × ULN；
    * INR or PT ≤ 1.5 × ULN； J) APTT ≤ 1.5 × ULN。

Exclusion Criteria:

1. History of symptomatic congestive heart failure, unstable angina pectoris,
2. Uncontrolled cardia arrhythmia
3. History of hepatic encephalopathy
4. Uncontrolled arterial hypertension
5. Co-infection with HBV and HDV
A Phase 1/Phase 2 Study of Polyvalent Pneumococcal Conjugate Vaccine (V116) in Adults (V116-001)

This Phase 1 and Phase 2 study will evaluate the safety, tolerability and immunogenicity of V116 when administered to adults. Phase 1 has no formal hypothesis. The primary hypotheses for Phase 2 are: V116 is noninferior to Pneumovax™23 as measured by the serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) for the common serotypes at 30 days postvaccination and that the serotype-specific OPA GMTs for the unique serotypes in V116 at 30 days postvaccination are statistically significantly greater following vaccination with V116 than those following vaccination with Pneumovax™23.


Eligibility Criteria:
Inclusion Criteria

* Phase 1:
* Male or female, from 18 years to 49 years of age inclusive
* Phase 2:
* Male or female ≥50 years of age Phase 1 and Phase 2
* Males: refrain from donating sperm, remain abstinent during study or agree to use condom
* Females: Not pregnant. If a woman of childbearing potential, agree to use contraception or remain abstinent

Exclusion Criteria

* History of invasive pneumococcal disease or known history of other culture-positive pneumococcal disease within 3 years of screening
* Known hypersensitivity to any component of the pPCV, or any diphtheria toxoid-containing vaccine
* Known or suspected impairment of immunological function including, but not limited to, a history of congenital or acquired immunodeficiency, documented human immunodeficiency virus (HIV) infection, functional or anatomic asplenia, or history of autoimmune disease
* Coagulation disorder contraindicating IM vaccination
* Recent febrile illness (defined as oral or tympanic temperature ≥100.4°F \[≥38.0°C\] or axillary or temporal temperature ≥99.4°F \[≥37.4°C\]) or received antibiotic therapy for any acute illness occurring within 72 hours of screening
* Known malignancy that is progressing or has required active treatment within 3 years.(Note: participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ \[eg, breast carcinoma, cervical cancer in situ\] that have undergone potentially curative therapy are not excluded)
* Pregnant
* Received any pneumococcal vaccine or is expected to receive any pneumococcal vaccine during the study, outside of the protocol.
* Receiving immunosuppressive therapy, including chemotherapeutic agents used to treat cancer or other conditions, and interventions associated with organ or bone marrow transplantation, or autoimmune disease
* Received a blood transfusion or blood products, including immunoglobulin, 6 months before study vaccination or is scheduled to receive a blood transfusion or blood product
Application of Radiomics in Breast Cancer

Little is known about the correlation between ultrasound characteristics (conventional, elastography and contrast enhanced ultrasound (CEUS) )and pathological prognostic factors in breast cancer. The aim of this study was to explore the correlation between ultrasound characteristics and pathological prognostic factors using radiomics.


Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of breast cancer

Exclusion Criteria:

Missing pathology Missing follow-up results Missing data
Clinical Effectiveness of Non-contact Heart Rate and Respiratory Rate Monitoring System

In this study, hospitalized neonates were taken as the focus of the study. The non-contact heart rate and respiratory rate monitoring system was used to measure heart rate, respiratory rate, sleep parameters, ECG monitor, neonatal sleep-wake scale, amplitude-integrated electroencephalography. aEEG), in order to provide a theoretical basis for standardizing the operation of medical staff and formulating sleep protection strategies in the future, so as to promote the sleep quality of hospitalized neonates and improve the prognosis of neonates.

The non-contact heart rate and respiratory rate monitoring system collected the body vibration signals of children through the heart rate and respiratory rate sensor, converted the pressure signals of vibration into electrical signals, extracted heart rate and respiratory rate, and extracted the characteristic parameters of sleep stages using heart rate and respiratory rate and body movement signals. It is characterized by no need to wear any equipment, the monitoring mattress is placed under the original baby mattress, no direct contact with the skin of the child, no comfort, and no change in the original sleep habits.

Eligibility Criteria:
Inclusion Criteria:

* Newborns admitted to our hospital for the first time, with gestational age ≥28w;
* Expected hospital stay ≥5 days.

Exclusion Criteria:

* Apgar score ≤3 at 1 or 5 min after birth;
* Severe congenital malformation; Severe hypoxic-ischemic encephalopathy, intraventricular hemorrhage of grade III and above; There were serious heart and lung diseases.
First-in-human Study of Orally Administered KT-621 in Healthy Adult Participants

This is a first-in-human study to evaluate safety, pharmacokinetics, and pharmacodynamics of single and multiple dose levels of KT-621 in healthy male and female adult participants.


Eligibility Criteria:
Inclusion Criteria:

* Participants aged 19 to 55 years (inclusive) at the time of consent, with a weight of at least 50 kg if male or 40 kg if female, and a body mass index (BMI) between 18.0 and 30.0 kg/m² (inclusive) at Screening.
* Evidence of a personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study.
* Participants must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
* Male participants (and their partners of childbearing potential) and female participants must agree to the contraception requirements as specified in the clinical protocol.
* Female participants may not be pregnant, lactating, or breast-feeding or plan to become pregnant (including ova donation) within 30 days of last study drug administration.
* Female participants must have a negative result for pregnancy test at Screening and on admission to the CRU.

Exclusion Criteria:

* Participants who have a clinically relevant history of respiratory, gastrointestinal (GI), renal, hepatic, hematological, lymphatic, endocrinological, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, ophthalmological, or connective tissue diseases or disorders.
* Participants who have a clinically relevant surgical history (eg, surgery of the GI tract that could interfere with the PK of the trial medication) Note: prior appendectomy or cholecystectomy is not exclusionary.
* Participants with a history of alcohol or substance abuse within the previous 5 years.
* Participants who have any known factor, condition, or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as drug or alcohol dependence or psychiatric disease.
* Participants who test positive for alcohol and drugs of abuse at Screening and on admission to the CRU.
* Participants who have acute GI symptoms at the time of Screening or admission to the CRU (eg, nausea, vomiting, diarrhea, heartburn).
* Participants whose results from clinical laboratory safety tests are outside the local reference range at Screening and on admission to the CRU.
* Participants who have previously received KT-621 in another cohort in this study.
* Participants who have been dosed with any investigational drug or device in a clinical study within 30 days or 5 half-lives (whichever is longer) of KT-621/placebo administration.
Brexpiprazole as Combination Therapy With Sertraline in Treatment of Adults With PTSD

This will be a 12-week, multicenter, randomized, double-blind trial evaluating the efficacy, safety, and tolerability of brexpiprazole + sertraline combination treatment in adult participants with Post-Traumatic Stress Disorder.


Eligibility Criteria:
Inclusion Criteria:

* Male and female outpatients 18 to 65 years of age, inclusive, at the time of informed consent.
* Participants who have PTSD, diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5), and confirmed by the Mini International Neuropsychiatric Interview (MINI).
* Onset of symptoms meeting the DSM-5 criteria for PTSD symptoms for a minimum of 6 months prior to screening.

Exclusion Criteria:

* The index traumatic event that led to the develop of PTSD took place \> 9 years before screening.
* The index traumatic event occurred before age 16.
* Participants who have experienced a traumatic event within 3 months of screening.
* Participants who are receiving disability payments because of PTSD or any other psychiatric disorder; unless the disability payments will not be impacted by potential improvements demonstrated in the trial.
MIcronized PROgesterone in Frozen Embryo Transfer Cycles

This randomized trial was designed as non-inferiority trial aiming to compare ongoing pregnancy rates following LPS with 600 mg/day vs 800 mg/day vaginal VMP. All patients will undergo an artificial cycle frozen embryo transfer (AC-FET) with transdermal estradiol 6mg/day Patients undergoing an artificial cycle FET will start estrogen priming with transdermal estradiol 6mg/day (Estrogel®) on cycle D1-D3. Following 10-12 days of estrogen priming, patients will be randomized to luteal phase support with a standard formulation (200mg tid, Utrogestan®) or a new formulation (400mg bid) VMP. All patients will undergo a serum P measurement on the day before embryo transfer (ET). Patients with P\<10 ng/ml will receive a supplement of oral micronized progesterone 300mg, while patients with P≥10ng/ml will maintain the previous luteal phase support (LPS) protocol


Eligibility Criteria:
Inclusion Criteria:

* Endometrial preparation with hormone replacement therapy
* Age 18-43 years following an autologous IVF cycle (with or without preimplantation genetic testing for aneuploidy)
* Age \< 50 years following an egg donation cycle
* BMI \> 18 and \< 30 kg/m2
* blastocyst embryo transfer
* Willing to participate in the study
* Able to come to the Center to comply with the procedures of the study: blood tests, appointments and drug dispensation.

Exlusion Criteria:

* • Uterine diseases (e.g. submucosal fibroids, polyps, previously diagnosed Müllerian abnormalities)
* Hydrosalpinx
* Recurrent pregnancy loss (≥ 3 previous miscarriages)
* Recurrent implantation failure (≥ 3 previously failed embryo transfers of good-quality blastocysts)
* Allergy to study medication
* Pregnancy or lactation
* Contraindication for hormonal treatment
* Personalized initiation of exogenous progesterone according to a previous endometrial receptivity assay test
* Recent history of severe disease requiring regular treatment (clinically significant concurrent medical condition that could compromise subject safety or interfere with the trial assessment).
Reducing the Abuse of Opioids in Drug Users

The consequences of prescription opioid abuse are serious and the number of deaths from unintended overdose have quadrupled over the last 15+ years. Opioid analgesics remain among the most commonly abused class of substances in the United States. Moreover, patients who take pain medications for legitimate reasons may develop an opioid use disorder (OUD), with as many as 1 in 4 patients becoming dependent on their pain medications. Because of changing access to prescription opioid analgesics due to an increasingly negative prescribing climate and changes in guidelines, patients often turn to heroin, with an estimated 1 in 15 pain patients trying heroin within 10 years. Pain is a symptom that can be severely debilitating and needs to be treated adequately to improve the quality of life. Clinicians, then, are in a proverbial "catch-22" situation whereby treating a patient's chronic pain also exposes them to medications with substantial abuse liability and overdose risk. In this proposal, a method aimed at reducing the abuse potential of prescription opioid medications, without altering their analgesic efficacy, is described.

The study team hypothesize that this can be accomplished by administering a fixed-dose-combination of an opioid with an atypical antipsychotic drug, in the same pill or capsule.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients between 21 to 65 years of age, capable of understanding and providing consent in English, and capable of complying with the outcome instruments used.
* Recreational opioid use (i.e. defined as prescription opioid use for nontherapeutic purposes on at least 10 occasions within the previous year and at least once in the 12 weeks prior to screening)
* Reported tolerated doses to opioid medications

Exclusion Criteria:

* Currently receiving pharmacotherapy for psychiatric disorder, current suicide risk, or past history of major psychiatric disorder such as bipolar disorder/psychosis
* Presence of dementia
* Current neuroleptic medication in past 30 days
* Pregnancy
* Positive drug urine test for Barbiturates, Benzodiazepines, Methadone, and Buprenorphine.
* Subjects with a prolonged QT interval greater than 430ms (i.e. QTc \>430ms)
* Subjects with a heart rate of less than 60 or greater than 100bpm will be assessed by a physician for symptomatic bradycardia/tachycardia and eligibility determined on a case-by-case basis
* Subjects with serum potassium and/or magnesium outside of normal range of our institutional laboratory within the past three months from time of screening.
* Subjects who appears intoxicated on the day of study visit by an on-site physician.
Evaluation of the Biocompatibility of Cartridge Blood Set Versus Standard Blood Line

The primary objective is to collect data to evaluate the biocompatibility of two types of blood circuit, already on the market.

Interactions between blood components (cells and proteins) and the extracorporeal circuit induce the activation of several biological systems such as platelets, complement and coagulation cascades. The coagulation system generates a key enzyme, factor IIa or thrombin, responsible for blood clotting in the dialysis circuit Because clotting in the circuit may reduce the dialysis efficiency, the anticoagulation of the extracorporeal circuit is needed .

For several years, most of the researches were mainly focused on the improvement of the biocompatibility of dialysis membranes .

The contribution of the various components of the dialysis circuit on the coagulation activation has not been clearly established.

A circuit integrating a cartridge blood set is commercialised for several years. The design of this cartridge blood set reduces the surface in contact with blood and minimizes the blood air interface which are well known sources of coagulation activation.

The aim of this study is to collect data to evaluate the biocompatibility of two types of blood circuit (cartridge blood set vs standard blood line).

Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from chronic renal failure,
* Patients treated in HD performed with or without heparin injection in the extra corporeal circuit (ECC) irrespective the type of heparin (UFH and LMWH),
* Patients treated three times a week for a minimum of three (3) months,
* Patients 18 years or older,
* Patients with a well-functioning vascular access as judged by the investigator,
* Patients with negative serologies (HIV, hepatitis),
* Patients having signed written informed consent to participate in the study.

Exclusion Criteria:

* Patients with known allergy to heparin,
* Patients with acute inflammatory event that may affect, as judged by the investigator, the results of the study or the safety of the patients,
* Active malignant disease,
* Pregnant women, nursing mothers and women planning a pregnancy during the course of the study,
* Patients under guardianship,
* Patients participating in other studies that could interfere with the objectives of this study,
* Patients treated in single needle mode,
* Patients with catheter,
* Patients receiving Anti-Vit K drug.
Study Evaluating PRA-027 Multiple Ascending Doses In Cycling And Postmenopausal Women

This is the first multiple-dose study in humans with PRA-027. This study will provide an assessment of the safety, tolerability, pharmacokinetics (how the drug is absorbed, metabolized and excreted by the body) and pharmacodynamics (a measure of whether the drug is active in the body) of PRA-027 after administration of 28 days of oral doses in women of childbearing potential (cycling) or postmenopausal women.


Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria - All Women

* Healthy, nonsmoker or smoker of fewer than 10 cigarettes (half a pack) per day and able to abstain from tobacco throughout all times when in the clinical facility.

Inclusion Criteria - Cycling Women

* Aged 18 to 45 years, must not be breastfeeding, pregnant, or have a recent (within 90 days before pretreatment period day 1) history of pregnancy, with a history of regular menstrual cycles (21 to 35 days in duration).

Inclusion Criteria - Postmenopausal Women

* Aged 35 to 65 years, menopause may be natural or due to surgery, natural amenorrhea must have begun by age of 55 years and have initiated at least 6 months before study day 1.

Exclusion Criteria:

* Women with hysterectomy or complex or simple ovarian cysts greater than 3 cm in diameter.
* History of drug abuse (within 6 months) or alcoholism (within 12 months).
* History of female infertility.
Treatment of Radiation-induced Fibrosis in the Upper Aerodigestive Tract Cancer by a Combination of Pentoxifylline-tocopherol and Hyperbaric Oxygen

The pentoxifylline used with tocopherol achieves a certain effectiveness in the treatment of the fibrosis.

Hyperbaric oxygen therapy has been recommended and used in a wide variety of medical conditions including the treatment of delayed radiation injuries (soft tissue and bony radiation necrosis). The hyperbaric oxygen therapy increases the formation of granulation tissue and produces angiogenesis maintained after use.

Patients with head and neck tumors often present superficial radiation induced fibrosis and other late complications of radiotherapy that can seriously affect their quality of life.

The pentoxifylline used with tocopherol achieves a certain effectiveness in the treatment of the fibrosis.

Hyperbaric oxygen therapy has been recommended and used in a wide variety of medical conditions including the treatment of delayed radiation injuries (soft tissue and bony radiation necrosis). The hyperbaric oxygen therapy increases the formation of granulation tissue and produces angiogenesis maintained after use.

Both treatments in combination could produce a synergistic effect because the angiogenesis induced by hyperbaric oxygen therapy allow better access to drugs to the injury. The magnetic resonance, provides data of the fibrosis and other side effects of radiotherapy.

Eligibility Criteria:
Inclusion Criteria:

1. Over 18 years and under 70 years old.
2. Patients who have received radiotherapy after being diagnosed with cancer of upper aerodigestive tract, and have skin toxicity grade II or higher.
3. Follow-up for at least a year after the radiation treatment is completed.
4. Absence of tumor at the time of recruitment.
5. Patients with the capacity to give informed consent

Exclusion Criteria:

1. Allergy or hypersensitivity to Pentoxifylline or others xanthines, or to Tocopherol (vitamin E).
2. Patients taking oral anticoagulants (acenocoumarol, warfarin).
3. Known hemorrhagic/coagulation disorder.
4. Vitamin K deficiency due to any cause.
5. Use of estrogens oral contraceptives.
6. Serious bleeding or extensive retinal hemorrhage.
7. Ischaemic heart diseases, including recent Myocardial Infarction.
8. Serious cardiac arrhythmia.
9. Severe liver disease.
10. Severe renal failure (creatinine clearance \<30 mL/min).
11. Hypotension.
12. Patients with metal objects or electronic devices such as cardiac pacemakers, artificial heart valves or cochlear implants, or any other contraindication for MRI
13. Contraindication for Hyperbaric oxygen therapy.
14. Patients with mobility problems.
15. Female patients who are pregnant or lactating
16. Any other situation or condition that, in the opinion of the investigator, may interfere with optimal participation in the study.
Study to Evaluate Safety, Tolerability, and Pharmacokinetics of UB-621 in Healthy Volunteers

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of a single subcutaneous dose of UB-621 in healthy volunteers.

This is a phase I, open-label, single dose, dose escalation study in healthy volunteers. Eligible volunteers will be sequentially enrolled into four escalating-dose cohorts at a study site. After administration of a single subcutaneous dose of UB-621, subjects will be followed for 70 or 112 days and monitored for safety, tolerability, and pharmacokinetics parameters.

Eligibility Criteria:
Inclusion Criteria:

* With age between 20 and 55 years.
* With no clinically relevant abnormalities in vital signs, and clinical laboratory tests at screening visit judged by investigator.
* Body weight: \<85 kg.
* Subject has signed the written informed consent form.

Exclusion Criteria:

* With significant active infection (acute or chronic) within 28 days prior to the screening visit.
* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic or allergic diseases, or clinical findings within 3 months prior to the screening visit.
* Positive serology for HIV antibody, HCV antibody or HBV surface antigen.
* Female subjects who are breastfeeding, pregnant, and planning to become pregnant during the study period.
* The clinical investigator considers that the subject is not in the condition to participate in this study.