rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Study of CM313 in Healthy Subjects
Status: Not yet recruiting

This study is a single center, randomized, open/double-blind, placebo-controlled, single dose, dose escalation Phase I clinical study aimed at evaluating the safety, tolerability, pharmacokinetics, pharmacokinetic characteristics, and immunogenicity of CM313 administered subcutaneously or intravenously at different doses in healthy male subjects.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Subjects age ≥ 18 years & ≤50 years. Subjects voluntarily signed the Informed Consent Form and were able to comply with the provisions of this protocol.  Exclusion Criteria:  With history of malignant tumors; Plan to undergo major surgery during the research period Known to be allergic to monoclonal antibody drugs or other related drugs, food, or CM313 excipients; With any voluntary blood donation or any other form of blood loss exceeding 400 mL; The average daily smoking volume within the first three months of screening is greater than 5 cigarettes; Positive results in baseline alcohol breath test or urine drug abuse screening. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Male - MinimumAge: 18 Years - MaximumAge: 50 Years - StdAgeList: Adult
Study of V117957 in Interstitial Cystitis/Bladder Pain Syndrome
Status: Recruiting

The purpose of this study is to evaluate the safety, tolerability and efficacy of V117957 in subjects with interstitial cystitis/bladder pain syndrome, compared to placebo.

Eligibility:
- EligibilityCriteria: Key Inclusion Criteria include:  Female, age ≥18 years and capable of voiding independently. Able to comply with acceptable methods of contraception. Diagnosis of IC/BPS or meets criteria for IC/BPS as defined by the American Urology Association as "an unpleasant sensation (pain, pressure, discomfort) perceived to be related to the urinary bladder, associated with lower urinary tract symptoms for more than six weeks duration, in the absence of infection or other identifiable causes". Subject has Bladder Pain/Interstitial Cystitis Symptom Scale (BPIC-SS) total score of ≥19 and worst bladder pain/discomfort sub-score of ≥4 to ≤9. Has undergone evaluation to rule out other conditions that cause bladder pain/discomfort. Any microscopic or gross hematuria that has not been evaluated in the past 12 months will require appropriate clinical evaluation to determine study eligibility.  Key Exclusion Criteria include:  Pelvic floor tenderness in the absence of bladder tenderness on physical examination by primary investigator. Urinary tract infection (UTI) within the past 30 days, or history of recurrent UTI. Hematuria determined to be associated with bladder malignancy or other significant pathology. Had surgical procedure at any time that affected bladder function. Received intravesical therapy or had bladder hydrodistension, fulguration, botulinum toxin, or triamcinolone bladder injection, percutaneous nerve stimulation. A subject receiving such treatment(s) prior to screening is eligible if in the opinion of the investigator the procedure/ treatment resulted in no notable or enduring effect and subject continues to exhibit stable symptomology. Has current or history of clinically significant kidney disease or abnormal kidney function, or nephrolithiasis.  Other protocol-specific inclusion and exclusion criteria may apply. - HealthyVolunteers: No - Gender: Female - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Immunomonitoring of Mold Invasive Infections
Status: Not yet recruiting

Mold invasive infections are associated with an important mortality despite optimization of the antifungal treatment. In a few case reports, immune checkpoints inhibitors, initially developed for neoplastic diseases, have shown a potential beneficial effect in such devastating infections by restoring an efficient immune response. The investigators propose a longitudinal monitoring of the adaptative immune response, notably immune checkpoint expression on T cells, during mold invasive infections to help identify the patients who could benefit from the adjunction of immunotherapy and the optimal timing of such strategy.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age > 18 years Mold invasive fungal infection: Aspergillus, Mucorales, Fusarium, Scedosporium Proven or probable according to 2019 EORTC/MGS criteria modified by the adjunction of diabetes mellitus in the host criteria and Mucorales PCR in the microbiological criteria Within 14 days of IFD diagnosis or at a refractory state defined by the 2009 MGS/EORT failure criteria (clinical, radiological, or microbiological failure) of a first-line antifungal treatment leading to a change of therapy by the attending physician of the patient  Exclusion Criteria:  Lymphocyte count < 0.5 G/L Bacterial infection in the last 14 days Previous treatment with anti-PD1 antibodies - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Tertiary care centers - SamplingMethod: Non-Probability Sample
Analgesia Nociception Index to Explore Autonomic Nervous System in Patients With Continuous Renal Replacement Therapy
Status: Not yet recruiting

The Analgesia Nociception Index (ANI) reflects the balance between sympathetic and parasympathetic tone. It is based on a specific interpretation of the R-R interval variation. During fluid removal by net ultrafiltration in patients with fluid overload and continuous renal replacement therapy, some data suggest that haemodynamic variation could be induced by the autonomic nervous system. The study aims to investigate ANI variations in this context and their association with the haemodynamic variations observed.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Continuous renal replacement therapy in intensive care unit  Initiation of net ultrafiltration according to the protocol of the department or to EARLYDRY study (NCT 05817539) (3 criteria required):  Fluid overload > 5% or peripheral oedema Noradrenaline equivalent <0.5μg/kg/min No peripheral hypoperfusion Invasive blood pressure monitoring Central venous line in superior vena cava territory Regular sinus rhythm Patient awake or Richmond Agitation and Sedation Scale > -3  Exclusion Criteria:  Ongoing administration of inotropes Ongoing administration of beta blockers Current administration of alpha-2 agonists History of dysautonomia Pregnant or breast-feeding woman Mechanical circulatory assistance Opposition to participate Adults under legal protection Persons deprived of their liberty by judicial or administrative decision - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Critically ill patients with continuous renal replacement therapy, fluid overload and haemodynamically stable. - SamplingMethod: Non-Probability Sample
Tace With Icaritin in First-line Treatment of Middle and Advanced HCC in Child Grade B Patients
Status: Not yet recruiting

Icaritin is a drug that has been approved by the National Medical Products Administration (NMPA) based on a multicenter, randomized, double-blind, parallel-controlled Phase III clinical trial - SNG1705 ICR-1. It is used for patients with unresectable hepatocellular carcinoma who are not suitable for or refuse standard treatment and have not previously received systemic therapy. According to numerous studies, in tumor cells, Icaritin can downregulate the expression of TNF-α, IL-6, PD-L1 and exert anti-tumor effects. At the same time, it regulates the tumor immune microenvironment by reducing the secretion of TNFa and IL-6 as well as inhibiting PD-L1 expression through decreasing MDSC cell proportion. Importantly, Icaritin has excellent safety profile and greatly ensure patients' quality of life clinically. Rare grade 3-4 TRAEs were observed in clinical trials which is uncommon among existing standard drugs. Good safety is a prerequisite for combination therapy; therefore, further exploration of optimal drug combinations is worth considering. Thus, TACE+Icaritin may potentially optimize treatment strategies for patients with poor liver function reserve.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  HCC was confirmed by histopathology or clinical diagnosis; No previous systematic therapy; Age 18-75 years old; CNLC: Ⅱb-Ⅲa stage; Child-Pugh grade B; ECOG PS score :0-1; No major vessel invasion or distant metastasis; Suitable for interventional treatment; Measurable disease according to mRECIST; Willing to sign informed consent; Willing and able to follow study protocols and visit plans.  Exclusion Criteria:  Patients who refuse or are not suitable for interventional treatment; Fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma and other components previously confirmed by histology/cytology; Prior systematic therapy for HCC, including chemotherapy agents, sorafenib, Renvastinib, regorafenib and other targeted agents or immunomodulators such as anti-PD-1, anti-PD-L1, anti-CTLA-4, other than antiviral therapy for patients receiving any other investigational drug; Contraindications for interventional therapy, such as severe cirrhosis, more than moderate ascites, and Child C liver function; 5, diagnosed as hepatic encephalopathy, sclerosing cholangitis, Gilbert disease;  6. A history of gastrointestinal bleeding or a definite tendency to gastrointestinal bleeding within the previous 6 months; 7. Serious dysfunction of vital organs such as heart, brain and lungs; 8.uncontrolled high blood pressure, gastrointestinal bleeding or coagulation dysfunction, etc.; 9. Pregnant or nursing patients; 10. Allergic to drugs or excipients used in the study; 11. Other conditions deemed inappropriate for participation in the study by the investigator. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult
HIV-1 Subtype-specific Drug Resistance in Patients Failing Dolutegravir (DTG) Based Regimen
Status: Recruiting

This is a prospective observational study enrolling People Living with HIV (PLHIV) who are on a Dolutegravir-based AntiRetroviral Treatment (ART) regimen and experiencing virologic failure. Virologic failure is defined as two consecutive viral load measurements of >1000 copies/mL of blood. The main aim of the study is to identify the drug-resistance mutations in the viral genome that are associated with this failure.

To achieve this goal, patients fulfilling the eligibility criteria will be invited for a single study visit for the collection of blood. The extracted HIV virus will be sequenced through whole genome sequencing methods to identify the drug-resistance mutations. The study is conducted in 15-20 countries within six regions of the IeDEA cohort (International epidemiology Databases to Evaluate AIDS).

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Adults aged 18 years or older and adolescents (10-17 years) On any DTG-based ART regimen Who develop virologic failure (VF) defined as a VL >1000 copies/mL (single or confirmed measurement), and have signed the informed consent.  Exclusion Criteria:  No Informed Consent - HealthyVolunteers: No - Gender: All - MinimumAge: 10 Years - StdAgeList: Child, Adult, Older Adult - StudyPopulation: Patients routinely treated at the local HIV care clinics. - SamplingMethod: Probability Sample
A Study of PF-07820435 as a Single Agent and in Combination in Participants With Advanced Solid Tumors
Status: Recruiting

This study aims to evaluate the safety, and early signals of anti-tumor activity of PF-07820435 when administered alone (Part 1A) or in combination with sasanlimab (Part 1B; Part 2) in patients with selected advanced or metastatic solid tumors. Part 1 will be dose-finding and Part 2 of the study will further evaluate PF-07820435 at the recommended dose for combination expansion in patients with selected advanced solid tumors.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Histological or cytological diagnosis of advanced, unresectable, and/or metastatic or relapsed/refractory solid tumor Part 1A: Participants with solid tumors where anti-PD-(L)1 is an established treatment. Participants must have progressed on or following prior anti-PD-(L)1 therapy if approved, available, tolerable, and eligible Part 1B: Participants either meeting Part 1A criterion, or participants with "cold" solid tumors where anti-PD-(L)1 therapy is not an established treatment Part 2: Participants with NSCLC (Arm A) must have received platinum-based chemotherapy and anti-PD-(L)1 or have intolerability to or refusal of standard therapies. NSCLC participants with known activating mutation(s) must also have received prior approved and available targeted therapy(ies) for the associated mutation(s) or have intolerability or documented refusal of these therapies. Participants with UC (Arm B) must have received prior platinum-based chemotherapy, anti-PD-(L)1 therapy, or enfortumab vedotin, or have documented intolerability or refusal of the standard therapy(ies). Additional cohort indication(s) or dose regimens may be added and defined based on emerging data At least 1 measurable lesion based on RECIST 1.1 that has not been previously irradiated (Part 1 exceptions permitted after review and approval) Able to provide pre-treatment (and optional on-treatment) tumor tissue  Exclusion Criteria:  Active or history of clinically significant gastrointestinal disease and other conditions that are unresolved or pose a risk to study treatment or procedures Active or history of pneumonitis/interstitial lung disease, pulmonary fibrosis requiring treatment with systemic steroid therapy Active or history of clinically significant autoimmune disease or other medical condition that required chronic systemic immunosuppressive therapy within recent 2 years History of severe immune-mediated adverse event or cytokine release syndrome that was considered related to prior immune modulatory therapy that required immunosuppressive therapy - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Deep Learning ECG Evaluation and Clinical Assessment for Competitive Sport Eligibility
Status: Recruiting

The goal of this observationl study is to evaluate the possibility of building a Deep Learning (DL) model capable of analyzing electrocardiographic traces of athletes and providing information in the form of a probability stratification of cardiovascular disease.

Researchers will enroll a training cohort of 455 participants, evaluated following standard clinical practice for eligibility in competitive sports. The response of the clinical evaluation and ECG traces will be recorded to build a DL model.

Researchers will subsequently enroll a validation cohort of 76 participants. ECG traces will be analyzed to evaluate the accuracy of the model to discriminate participants cleared for sports eligibility versus participants who need further medical tests

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Athletes in need of cardiac or sports medical evaluation for the issuance of competitive eligibility. Enlisted athletes involved in sports like soccer or those with mixed or aerobic cardiovascular demands according to the COCIS 2017 classification. Aged 18 years or older but not exceeding 60 years. No history of cardiovascular disease. Signed Informed Consent.  Exclusion Criteria:  Athletes engaging in skill-based sports as per the COCIS 2017 classification. High clinical probability of cardiovascular disease, such as typical angina or heart failure. Pregnancy and/or breastfeeding (confirmed through self-declaration). - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 60 Years - StdAgeList: Adult - StudyPopulation: Adults requiring medical evaluation for competitive sports eligibility - SamplingMethod: Non-Probability Sample
Post-Marketing Surveillance (All Case Surveillance) on Treatment With Alhemo® in Patients With Haemophilia A or Haemophilia B With Inhibitors
Status: Not yet recruiting

The purpose of the study is to investigate the safety and effectiveness of Alhemo® in all participants under real-world clinical practice in Japan. Participants will get Alhemo® as prescribed by the study doctor. The study will last for about 2 years.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol) The decision to initiate treatment with commercially available Alhemo® has been made by the patient/LAR and the treating physician before and independently from the decision to include the patient in this study Male or female patients, regardless of age Diagnosis with HAwI/HBwI  Exclusion Criteria:  - Previous participation in this study. Participation is defined as having given informed consent in this study - HealthyVolunteers: No - Gender: All - StdAgeList: Child, Adult, Older Adult - StudyPopulation: Participants with haemophilia A or haemophilia B with inhibitors will be treated with commercially available concizumab according to routine clinical practice at the discretion of the treating physician. - SamplingMethod: Non-Probability Sample
Deep Learning Model Predicts Pathological Complete Response of Lung Cancer Following Neoadjuvant Immunochemotherapy
Status: Not yet recruiting

This study presents the development and validation of an artificial intelligence (AI) prediction system that utilizes pre-neoadjuvant immunotherapy plain scans and enhanced multimodal CT scans to extract deep learning features. The aim is to predict the occurrence of pathological complete response in non-small cell lung cancer patients undergoing neoadjuvant immunochemotherapyy.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients' with non-small cell lung cancer, diagnosed through biopsy pathology and clinically classified as stage IB to III; Patients who receive at least two cycles of neoadjuvant immunotherapy combined with chemotherapy induction therapy; According to the IASLC guidelines, postoperative pathological evaluation was performed on the treatment response of the tumor primary lesion and lymph nodes.  Exclusion Criteria:  Missing or inadequate quality of CT; Time interval between CT and start of treatment is greater than 1 month; Incomplete clinicopathologic data. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult - StudyPopulation: patients who were diagnosed with non-small cell carcinoma and undergo surgery after neoadjuvant chemoimmunotherapy treatment - SamplingMethod: Non-Probability Sample
Decreasing Loneliness to Optimize Pain Care
Status: Not yet recruiting

Loneliness, which is the perceived feeling of insufficient personal relationships, is related to higher risk for inappropriate opioid use and opioid use disorders in patients who are taking opioids long-term. The study seeks to pilot test the evidence-based loneliness interventions of psychological therapy and social navigation in patients on chronic opioids treated in primary care practices to determine if reducing loneliness can lower opioid misuse.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  18 years or older English-speaking On chronic opioids (defined as defined as 3 or more months receiving prescribed opioids [functional definition is 3 or more opioid prescriptions each less than 21 days apart as per our prior studies]) With a score greater or equal to 6 on the UCLA Loneliness 3-item Scale Have a chronic pain diagnosis  Exclusion Criteria:  Have cancer-related pain Are on palliative care or live in a controlled setting (i.e., assisted living, nursing home or inpatient treatment facility) Have an upcoming scheduled surgery Severe cognitive impairment or active psychosis - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Modified TOMOX-HAIC in Combination With Sintilimab and Bevacizumab Biosimilar for First-line Treatment of Advanced Hepatocellular Carcinoma
Status: Recruiting

This is a single-center, single-arm, phase II clinical study, to explore the efficacy and safety of modified TOMOX-HAIC combined with sintilimab and bevacizumab biosimilar as first line treatment in patients with advanced hepatocellular carcinoma.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Be willing and able to provide written informed consent/assent for the trial. Males or unpregnant females who age ≥ 18 years, ≤75 years. The investigator believes the patient is capable of complying with the study protocol. Histologically, cytologically or clinically confirmed advanced hepatocellular carcinoma. is not a candidate for radical surgery not received previous systemic treatment patients must have at least one measurable lesion (RECIST 1.1) ECOG PS：0-1, 14 days before enrollment Child-Pugh A or Child-Pugh B ≤ 7, 14 days before enrollment  Exclusion Criteria:  Prior history of other malignant tumors Current or prior immunodeficiency disorders or autoimmune diseases Subjects have untreated or incompletely treated esophageal and/or gastric varices with bleeding or high risk of bleeding Subjects who are not available for follow-up or are participating in other clinical trials that have the potential to interfere with this study Conditions considered unsuitable for inclusion by researchers - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult
Desmopressin Monotherapy for Monosymptomatic Nocturnal Enuresis
Status: Not yet recruiting

Nocturnal Enuresis (NE) is defined as the involuntary passage of urine during sleep past the age of usual control, which is considered a developmental age of 5 to 7 years.

NE is a common problem that causes distress to both children and their families. It has an adverse impact on behavior and social life, affects self-esteem, and can result in poor emotional well-being. In Egypt, the prevalence of NE in primary school children is about 15.4%. The family history was seen to have had a markedly significant impact on the occurrence of NE in the studied children. The mainstay of treatment is urotherapy with information and psychoeducation about normal lower urinary tract function, the underlying cause of MNE, disturbed bladder dysfunction in the child with NMNE, and instructions about therapeutic strategies. Alarm therapy and desmopressin are effective in randomized trials. Children with NMNE first need treatment of the underlying daytime functional bladder problem before treatment of nocturnal enuresis.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  School age group (from 7 to 14 years) Primary monosymptomatic nocturnal enuresis  Exclusion Criteria:  Patients with one or more of the following will be excluded from the study.  Diurnal enuresis Urinary tract infection within the preceding 3 months Diabetes mellitus History of renal disease, hypertension or genitourinary abnormality, neurological disease, or psychological disease. Post-micturition residual urine >1/3 expected bladder capacity. Each patient will be subjected to the following. - HealthyVolunteers: No - Gender: All - MinimumAge: 7 Years - MaximumAge: 14 Years - StdAgeList: Child