cyrilzakka/clinical-trials huggingface dataset:
Safety and Tolerability of IPH4502 in Patients With Advanced Solid Tumors

This is a first-in-human, open-label, multicenter, Phase 1 study to evaluate the safety, tolerability and preliminary efficacy of IPH4502 and to determine the recommended Phase 2 dose (RP2D) in advanced solid tumors that are known to express Nectin-4

This is a first-in-human, open-label, multicenter, single-arm Phase 1 study, with a part 1 dose escalation guided by a Bayesian optimal interval design with backfilling (BOIN-BF), followed by a part 2 dose optimization in up to 2 selected indications. This study is to measure the safety, tolerability, pharmacokinetics, and preliminary efficacy of escalating doses of IPH4502 in patients with advanced solid tumors that are known to express Nectin-4.

Eligibility Criteria:
Main Inclusion Criteria:

* Histologically confirmed, unresectable, locally advanced or metastatic solid tumors that are known to express Nectin-4
* Prior systemic treatment for locally advanced or metastatic disease, yet no therapy with demonstrated clinical benefit for the tumor type is available.
* Measurable disease according to RECIST 1.1.
* Archival tumor tissue obtained within 4 months of screening and since the last anticancer therapy prior to the study or agree to undergo a tumor biopsy at baseline.
* Adequate organ function and hematological function.

Main Exclusion Criteria:

* Known or suspected brain metastases.
* Participants with an active infection, Any other infection requiring systemic treatment or latent infection.
* Participants with clinically significant comorbidity(s).
* History of treatment for, or suspicion or confirmed interstitial lung disease (ILD) at baseline.
* Condition being treated with systemic corticosteroids or immunosuppressive therapy during IPH4502 treatment.
* Thromboembolic event requiring anticoagulation therapy ≤14 days prior to the first dose of IPH4502.
* Clinically significant cardiovascular disease and/or cardiac repolarization abnormality.
* Participants with symptomatic heart failure, Acute coronary syndromes
* Participant is receiving or has received anticancer therapy prior to enrolment that may have impact on the assessment of IPH4502.
* Major surgery ≤28 days and minor surgery ≤7 days prior to first dose of IPH4502 or 6 months for coronary artery bypass surgery.
* Concomitant medications or vaccines : Live-attenuated vaccines ≤ 6 weeks prior to first dose of IPH4502; systemic corticosteroids or other immunosuppressive agents within 14 days prior to the first dose of IPH4502; systemic use of moderate or strong CYP 3A4 inhibitors; systemic use of moderate or strong CYP 3A4 inducers.
Confirmatory Study of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)

This study was designed to provide pivotal confirmation of efficacy and safety data for 2 doses of indacaterol (150 and 300 µg once daily \[od\]) in patients with moderate to severe chronic obstructive pulmonary disease (COPD). Data from this study will be used for the registration of indacaterol in Japan.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of moderate-to-severe chronic obstructive pulmonary disease (COPD), as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines and:

  1. Smoking history of at least 20 pack-years.
  2. Post-bronchodilator forced expiratory volume in 1 second (FEV1) \< 80% and ≥ 30% of the predicted normal value.
  3. Post-bronchodilator FEV1/FVC (forced vital capacity) \< 70%.

Exclusion Criteria:

* Patients who have been hospitalized for a COPD exacerbation in the 6 weeks prior to screening or during the 14 day run-in period prior to randomization.
* Patients requiring long-term oxygen therapy (\> 15 hours a day) for chronic hypoxemia.
* Patients who have had a respiratory tract infection within 6 weeks prior to screening.
* Patients with concomitant pulmonary disease.
* Patients with a history of asthma.
* Patients with diabetes Type I or uncontrolled diabetes Type II.
* Any patient with lung cancer or a history of lung cancer.
* Any patient with active cancer or a history of cancer with less than 5 years disease-free survival time.
* Patients with a history of long QT syndrome or whose QTc interval (Bazett's) measured at screening or randomization is prolonged.
* Patients who have been vaccinated with live attenuated vaccines within 30 days prior to screening or during the run-in period.
* Patients unable to successfully use a dry powder inhaler device or perform spirometry measurements.

Other protocol-defined inclusion/exclusion criteria applied to the study.
Evaluation of Post-operative Biochemical Recurrence in Patients Submitted to Radical Prostatectomy Under General Opioid-free Anesthesia Compared to Conventional General Anesthesia

The use of opioids facilitates angiogenesis and has a proven action in the immune system, mainly in the reduction of natural killer cell activity, favoring the migration of neoplastic cells and inhibiting humoral and cellular immunity. These factors may contribute to recurrence and tumor metastasis.

Therefore, could opioid-free anesthesia help reduce tumor recurrence? This is a prospective randomized controlled clinical trial in which patients undergoing radical prostatectomy will be evaluated by conventional means, which have moderate and high D'Amico criteria for tumor recurrence.

In the operating room, patients will be monitored, receive peripheral venoclysis and then randomized into two groups: in group I, the anesthetic induction will be done with pre oxygenation with 100% O2, propofol, cisatracurium, lidocaine and fentanyl; In group II the induction will be done with the same doses of propofol, cisatracurium, lidocaine and placebo.

In both groups maintenance of general anesthesia will be with propofol 1% target infusion controlled with model of Marsh target-controlled infusion plasma between 2.0 and 3.0 mcg / ml, ketamine, lidocaine and dexmedetomidine.

Both groups will receive blockade of the transverse plane of the ultrasound guided ultrasound, group I with placebo (saline 0.9% 20 ml on each side) and group II with ropivacaine 0.375% 20 ml on each side. And the postoperative analgesia will be based on anti-inflammatory and opioid analgesics (pca of morphine) according to the analgesic pain scale of the patients.

In the postoperative period, patients will be followed up for 2 years with serial doses of prostate specific antigen (PSA) to diagnose tumor recurrence (2 PSA measures\> 0.2 ng / ml) and will be evaluated in relation to analgesia, need for analgesia of Rescue with morphine, satisfaction with the anesthetic technique, adverse effects (nausea and vomiting).

The primary objective is to evaluate tumor biochemical recurrence after radical prostatectomy in patients undergoing opioid anesthesia compared to patients anesthetized without opioids. The secondary objectives are to evaluate the quality of analgesia with the two techniques, patient satisfaction with perioperative period, quality of anesthetic recovery and adverse effects (nausea and vomiting, pruritus and drowsiness).

Thus, to answer the hypothesis raised, 146 patients will be needed (73 in each group).


Eligibility Criteria:
Inclusion Criteria:

* Prostate Cancer;
* Intermediate to high risk of recurrence by D'Amico criteria (Gleason scale \> or = 7; PSA \> or = 10)

Exclusion Criteria:

* Patient refuse;
* atrioventricular blockade;
* Coagulopathy;
* Other procedure at same time.
A Study of SRP-9005 in Limb Girdle Muscular Dystrophy Type 2C/R5 Pediatric and Adult Participants

This is a study of a single systemic dose of SRP-9005 in pediatric and adult participants with limb girdle muscular dystrophy type 2C/R5 (LGMD2C/R5). It is comprised of 2 parts (Part A, Part B) that will assess safety and efficacy.


Eligibility Criteria:
Key Inclusion Criteria:

* Ambulatory, defined as able to walk without assistive aid, 10MWR \<30 seconds, and NSAD total score ≥20
* Non-ambulatory, defined as 10MWR ≥30 seconds or unable to perform, and PUL 2.0 entry scale score ≥3
* Possess 1 homozygous or 2 heterozygous pathogenic and/or likely pathogenic gamma-SG deoxyribonucleic acid (DNA) gene mutations as documented prior to pre-Infusion screening. Results to be confirmed by sponsor at a CLIA/CAP/ISO15189 certified laboratory prior to dosing.
* Have AAVrh74 antibody titers \<1:400 (that is, not elevated) as determined by an enzyme-linked immunoassay

Key Exclusion Criteria:

* Has a symptomatic infection (for example, upper respiratory tract infection, pneumonia, pyelonephritis, meningitis) within 4 weeks before study treatment infusion
* Part A: Has left ventricular ejection fraction (LVEF) \<50% on the screening echocardiogram (ECHO) (without use of cardiac medication) or clinical signs and/or symptoms of cardiomyopathy or any history of cardiac disease
* Part B: Has LVEF \<40% on the screening ECHO or clinical signs and/or symptoms of cardiomyopathy
* Has FVC \<40% of predicted value at screening and/or requirement for nocturnal ventilation
* Serological evidence of current, chronic, or active human immunodeficiency virus infection, or hepatitis B or C infection or active viral or bacterial infection based on clinical observations
* Any prior treatment with gene therapy, cell-based therapy (for example, stem cell transplantation), clustered regularly interspaced short palindromic repeats/CRISPR-associated protein 9 (CRISPR/Cas9), or any other form of gene editing
* Treatment with human growth factor within 3 months of Day 1
* Treatment with any investigational medication within 6 months of the screening visit
* Is unable to undergo or tolerate a cardiac MRI procedure for any reason

Note: Other inclusion/exclusion criteria may apply.
Study of Molecular and Genetic Abnormalities in Patients With Myeloid Neoplasms

The objective of this study is to describe the prevalence and prognostic impact of the most common genetic abnormalities in patients with Myeloid Neoplasms, including Acute Myeloid Leukemia (AML), Myeloproliferative Neoplasms (MPN), Myelodysplastic Syndromes (MDS) and Myeloproliferative/Myelodysplastic Neoplasms. Patients will have samples of blood and/or bone marrow collected and sent to Hospital Israelita Albert Einstein for analysis and storage.

Patients with a diagnosis of Acute Myeloid Leukemia will be treated according to an uniform protocol.


Eligibility Criteria:
Acute Myeloid Leukemia-Intensive Chemotherapy

Inclusion Criteria:

* Diagnosis of AML according to WHO criteria
* Age greater than 18 years
* Performance status (ECOG) between 0-2
* Adequate liver and kidney function
* Signed Informed Consent form
* No prior therapy for AML, except use of hydroxyurea for control of elevated white blood cell counts
* Adequate contraception for fertile men and women
* Eligible for intensive chemotherapy (as judged by the treating physician)

Exclusion Criteria:

* Acute myeloid leukemia with retinoic acid receptor alpha (RARA) translocations (APL, acute promyelocytic leukemia)
* Pregnant women
* HIV-positivity
* New York Heart Association class III and IV congestive heart failure
* Patient refuses to use adequate contraception
* History of hypersensibility to any of the used chemotherapy drugs
* Patient refuses to sign informed consent form

Acute Myeloid Leukemia-Non-Intensive Chemotherapy

Inclusion Criteria:

* Diagnosis of AML according to WHO criteria
* Age greater than 18 years
* Signed Informed Consent form
* No prior therapy for AML, except use of hydroxyurea for control of elevated white blood cell counts
* Adequate contraception for fertile men and women
* Non-eligible for intensive chemotherapy (as judged by the treating physician)

Exclusion Criteria:

* Acute myeloid leukemia with RARA translocations (APL, acute promyelocytic leukemia)
* Pregnant women
* HIV-positivity
* Patient refuses to use adequate contraception
* History of hypersensibility to any of the used chemotherapy drugs
* Patient refuses to sign informed consent form

Chronic Myeloid Disorders:

Inclusion Criteria:

* Diagnosis of Myeloproliferative Neoplasm or Myelodysplastic Syndrome or Myeloproliferative/Myelodysplastic Neoplasm according to WHO criteria
* Age greater than 18 years
* Signed Informed Consent form

Exclusion Criteria:

* Patient refuses to sign informed consent form
Performance of REMS Bone Densitometry in a British Population

Radiofrequency echographic multispectrometry (REMS) is a recently developed technology that uses ultrasound to assess bone density and bone quality. It was launched in 2018 since when OsteoscanUK Ltd has offered a clinical bone health service using a REMS scanner. REMS is an alternative to x-ray based dual energy x-ray absorptiometry (DEXA) scans which are considered the "Gold Standard" for clinical densitometry. REMS is unique in offering not only bone density but also bone quality assessments in real time for both the spine and hip.

All patients who undergo REMS scans through the OsteoscanUK bone health service, are provided with a comprehensive consent form at least two weeks ahead of the scan and are required to complete the form before the scan is performed. The process allows consent for use of their anonymized data for research purposes and is consistent with the General Data Protection Regulations in the United Kingdom (UK) and Europe.

Once a REMS scan has been completed, data is extracted from the report and is entered into an Microsoft Excel spreadsheet. Data collected includes: age, age at menopause if female, current Fracture Risk Assessment (FRAX) score, body mass index, bone mineral density results for the hip and spine, fragility scores for the hip and spine and any history of a fragility fracture.

The spreadsheet is securely stored on a password protected server and the data controller is the only person with access. Associate researchers will be provided with data from exports of parts of the spreadsheet to allow them to carry out statistical analyses. All such data will be managed on secure computers controlled by OsteoscanUK.

Results of the data analysis will be collected, analysed and presented as a series of papers to be published in peer review journals. At the time of submission of such papers, the anonymized data set would be made available to the journal editors and reviewers as required for the purposes of publishing.

Eligibility Criteria:
Inclusion Criteria:

* All women over the age of 20 years presenting for a REMS scan

Exclusion Criteria:

* Lack of consent for the procedure and for the anonymised data to be stored and used for research; Previous bilateral total hip replacements; un controlled spasticity following a neurological injury of development of a neurodegenerative condition
Study on Post-Acute COVID-19 Syndrome in Improvement of COVID-19 Rehabilitated Patients by Respiratory Training

Since the emergence of Corona Virus Disease 2019(COVID-19), it has spread rapidly around the world, And it has had a profound impact on the lives and health of people around the world, most of the COVID-19 positive patients are 3-4 weeks after the onset of infection patients can turn negative and recover, however, increasing observational data suggest that these patients long-term or recurring symptoms such as: fatigue, palpitations, cognitive impairment, dyspnea, anxiety, chest tightness and Pain, etc., symptoms may last at least two months or even longer (for example, up to 12 months), the patient's quality of life and The ability to work and social activities also decline accordingly. Therefore, in addition to the acute symptoms after infection, patients also face the same. The challenge of long-term health sequelae associated with COVID-19.

Relevant studies have shown that breathing training can improve the exercise capacity, lung function, and respiratory rate of patients who have recovered from COVID-19. Difficult and other aspects are safe and effective. However, because COVID-19 is an emerging disease, the clinical research literature so far has limited Clinical data are still insufficient, and the effect of respiratory training on the breathing and physical function of COVID-19 patients has not been determined, and most of the patients are not living in the hospital. How to carry out simple and effective breathing training to reduce the long-term impact of COVID-19 on patients is worthy of continuous discussion. This study will assist COVID-19 patients to perform respiratory training with incentive spirometer intervention, and collect patients before and after the intervention Oxygen requirements, blood draw values and Post-COVID-19 Functional Status scale(PCFS scale) and other data to explore and evaluate the effect of interventional breathing training on the improvement of symptoms of new coronary pneumonia, as a reference for future clinical treatment and improvement of symptoms of COVID-19.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who have recovered from COVID-19

Exclusion Criteria:

1. Have suffered from within one year. Those who have recovered from COVID-19 must present proof of diagnosis, such as a medical certificate or screening results, etc., and ICD10 when seeking medical treatment The diagnostic codes are: U07.1 Confirmed COVID-19 virus infection, U09.0 Severe specific infectious pneumonia (COVID-19), unspecified.
2. adult, aged 20-90
3. conscious mind and behavior normal mental state examination (Mini-Mental State Examination, MMSE) score \> 21 points.
4. Those who can communicate in verbal or non-verbal ways and understand Chinese and Taiwanese.
5. are willing to participate in the research and agree to accept random machine dispatcher
Volume Controlled Ventilation vs Autoflow-volume Controlled Ventilation

Volume controlled ventilation(VCV) is a most common used ventilation mode during general anesthesia. But VCV can cause high airway peak pressure when patient under steep Trendelenberg position with pneumoperitoneum. Autoflow-VCV can reduce airway peak pressure and improve dynamic compliance. We will compare parameters(arterial blood gas analysis, airway compliance, etc) when each group applied VCV and autoflow-VCV during RALP.

Robot assisted laparoscopic radical prostatectomy(RALP) has been used to treatment of prostate cancer since 2001. RALP offers some advantage such as reduced blood loss, sparing nerves, less postoperative pain. However, RALP require steep Trendelenberg position with pneumoperitoneum. It can cause increased airway peak pressure and unwanted hemodynamic effect under conventional volume controlled ventilation(VCV). Autoflow-VCV use decelerating flow, can reduce airway peak pressure and improve dynamic compliance.

We will compare parameters(arterial blood gas analysis, airway compliance, etc) when each group applied VCV and autoflow-VCV during RALP.

Eligibility Criteria:
Inclusion Criteria:

* Adult (age 19-65)
* American Society of Anesthesiology Classification I-III

Exclusion Criteria:

* cardiovascular disease, cerebrovascular disease, pulmonary disease
* over BMI 30
A Study on the Tolerability and Early Efficacy of hLF1-11 in Patients With Proven Candidaemia

This is a phase-I, double-blind, randomized study with hLF1-11 to study the tolerability and early efficacy of hLF1-11 compared to standard fluconazole therapy in hospitalized patients with invasive Candida infection.

RATIONALE FOR THE STUDY

Choice of Drug

Fluconazole is considered "standard care" for the treatment of Candida infections, including candidaemia in hospitalized patients.

Preclinical data has demonstrated that hLF1-11 possesses potent antimycotic effects against Candida sp and, importantly, to be synergistic with fluconazole, whereby Candida strains that are fluconazole-resistant become sensitive through the addition of hLF1-11

Choice of Patient Population

Based on preclinical data hLF1-11 has been shown to possess potent effects on Candida albicans models in vitro and in vivo. Furthermore, candidaemia (bloodstream Candida infection) is one of the most likely settings to elicit a therapeutic response since the product is presented as an intravenous formulation

As previously mentioned, fluconazole and hLF1-11 exhibit a synergistic effect in preclinical studies, whereby the effect of fluconazole is enhanced by the addition of hLF1-11.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent must be obtained before admission in the study.
* Patients in whom Candida species have been confirmed by 2 consecutive blood cultures within 12 hours.
* Patients who have not received systemic administration of antifungal agents or who have started such administration within 48 hours prior to entry.
* Patients who have hepatic and renal parameters within 2X ULN (upper level of normality) at screening.

Exclusion Criteria:

* Patients with a history of hypersensitivity to fluconazole or hLF1-11.
* Patients who have been treated with fluconazole for at least 1 week within the previous 4 weeks.
* Patients with a history of fluconazole-resistant Candida species within 12 weeks.
* Neutropenic patients with neutrophil count below 0.5x10\^9/L.
* Patients who are treated with terfenadine, triazolam, cisapride, and ergotamine, which are contraindicated for concomitant use with fluconazole.
* Patients known to have AIDS or who are HIV-positive.
* Females who have a positive pregnancy test at baseline or are capable of child-bearing i.e. without appropriate contraception (chemical or mechanical).
* Patients with suspected candida osteomyelitis, endocarditis, or meningitis.
* Patients who have received an investigational drug within three months prior to the study.
* Patients with a concomitant medical condition, in whom, in the opinion of the Investigator, participation may create an unacceptable risk for the patient.
* Patients considered inappropriate by the PI for enrollment in the study, for any reason.
Expanded Access to SUVN-G3031 (Samelisant) for the Treatment of Subjects With Narcolepsy

The study is planned to provide expanded access treatment to subjects with narcolepsy who have completed the 2-week treatment phase and follow-up in study CTP2S13031H3 (NCT04072380), and in instances when the investigator as well as the subject believe that the benefits outweigh the risks to continue the treatment with SUVN-G3031.

The qualified subjects will be given 2mg of SUVN-G3031 expanded access treatment for 30 days. At the end of 30 days if the subject wishes to continue the treatment, he/she will be provided with adequate investigational drug for next 30 days. This cycle will be repeated up to a maximum of 2 times (total duration of expanded access treatment up to 90 days).

Eligibility Criteria:
Inclusion Criteria:

1. Subjects who have completed the 2-week treatment phase and follow-up period of study CTP2S13031H3 (NCT04072380) as planned and wish to continue unblinded treatment with SUVN-G3031 (2 mg, qd).
2. Subject must sign the ICF to participate in the study.
3. The investigator after review of relevant information and in consultation with the subject believes that continued treatment following study CTP2S13031H3 could be beneficial to the subject.

Exclusion Criteria:

1. Any clinically relevant concomitant disease or AEs/SAEs during the Phase 2 study (CTP2S13031H3), which in the opinion of the investigator, makes the subject unsuitable for inclusion in the protocol.
2. Has participated or is participating in any other clinical (investigational) study after completion of CTP2S13031H3 protocol (NCT04072380).