cyrilzakka/clinical-trials huggingface dataset:
A Study Evaluating the Immunogenicity of Different Clinical Trial Materials of Ad26.RSV.preF- Based Vaccine in Adults Aged 60 - 75 Years Old

The purpose of this study is to demonstrate non-inferiority in terms of humoral immune responses induced by vaccination with one dose of the Phase 3 clinical trial material (CTM) compared with one dose of the Phase 2b CTM.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to adhere to the prohibitions and restrictions specified in the protocol
* Before randomization, a participant must be postmenopausal (postmenopausal state is defined as no menses for 12 months without an alternative medical cause); and not intending to conceive by any methods
* In the investigator's clinical judgment, participant must be in stable health at the time of vaccination. Participants may have underlying illnesses such as hypertension, congestive heart failure, chronic obstructive pulmonary disease, type 2 diabetes, hyperlipoproteinemia, or hypothyroidism, as long as their symptoms and signs are stable at the time of vaccination, and these conditions receive routine follow-up by the participant's healthcare provider. Participants will be included on the basis of medical history, and vital signs performed between informed consent form (ICF) signature and vaccination
* Must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study
* From the time of vaccination through 3 months after vaccination, agrees not to donate blood

Exclusion Criteria:

* Known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients (including specifically the excipients of the study vaccine)
* Abnormal function of the immune system resulting from clinical condition or medication
* History of acute polyneuropathy (example, Guillain-Barré syndrome) or chronic idiopathic demyelinating polyneuropathy
* History of thrombosis with thrombocytopenia syndrome (TTS) or heparin-induced thrombocytopenia and thrombosis (HITT)
* Has had major surgery (per the investigator's judgment) within 4 weeks before administration of the study vaccine or will not have recovered from surgery per the investigator's judgment at time of vaccination
A Study to Evaluate the Efficacy and Safety of QLF31907 Combination Therapy in Patients With Advanced Malignant Tumors

This study is designed to evaluate the safety and efficacy of QLF31907 combination therapy in advanced malignant tumors.


Eligibility Criteria:
Inclusion Criteria:

1. subjects voluntarily participated and signed a written informed consent form;
2. age ≥18 years, male or female;
3. ECOG PS 0-1;
4. histopathologically diagnosed advanced malignant tumors;
5. at least 1 measurable lesion according to RECIST v1.1 criteria or Lugano (2014) criteria;
6. adequate organ function;

Exclusion Criteria:

1. previous treatment with 4-1BB agonist or 4-1BB recombinant fusion protein;
2. received anti-tumor therapy within 4 weeks prior to the first study treatment;
3. history of autoimmune disease;
4. history of other active malignancies within 3 years prior to the first treatment;
5. history of serous cardiovascular events;
Study of Danicopan as Add-on Treatment to Ravulizumab or Eculizumab in Pediatric Participants With PNH Who Have Clinically Significant Extravascular Hemolysis

The primary objective of this study is to evaluate efficacy of danicopan as add-on treatment to ravulizumab or eculizumab as assessed by hemoglobin (Hgb) change from Baseline at Week 12 in pediatric participants with paroxysmal nocturnal hemoglobinuria (PNH) and clinically significant extravascular hemolysis (CS-EVH).


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of PNH.
* CS-EVH defined by: Anemia: Hgb ≤ 10.5 g/dL, and absolute reticulocyte count ≥ 100 × 109/L
* Treated with ravulizumab or eculizumab for at least 12 weeks immediately preceding Day 1, the dose received should be stable during this period, and there should be no anticipated changes in dosage or interval during the first 12 weeks of this study.
* all participants must be vaccinated against meningococcal infection from serogroups A, C, W, and Y and serogroup B within 3 years prior to, or at least 14 days prior to Day 1
* vaccinated against Haemophilus influenzae type b (Hib) and Streptococcus pneumoniae

Exclusion Criteria:

* Platelet count \< 30000/μL or there is a need for platelet transfusions.
* ANC \< 500/μL.
* Clinically significant laboratory abnormalities related to liver function, including:

  * ALT \> 2 × ULN or ALT \> 3 × ULN for participants with documented liver iron overload defined by serum ferritin values ≥ 500 ng/mL.
  * Direct bilirubin \> 2 × ULN, unless, in the Investigator's opinion, is due to hemolysis or Gilbert's syndrome based on medical history.
* Current evidence of biliary cholestasis.
* Known aplastic anemia or other bone marrow failure that requires HSCT or other therapies, including anti-thymocyte globulin and immunosuppressants unless the dosage of immunosuppressant has been stable for at least 12 weeks before Day 1 and is expected to remain stable through Week 12.
* History of a major organ transplant (eg, heart, lung, kidney, liver) or HSCT.
* Known or suspected complement deficiency.
* Active bacterial or viral infection, a body temperature \> 38°C on 2 consecutive daily measures, evidence of other infection, or history of any febrile illness within 14 days prior to first study intervention administration.
DeNovo NT Ankle LDC Study

The purpose of this post-market clinical study is to collect long-term outcomes for DeNovo NT Graft treatment of articular cartilage lesions in the ankle in a standard clinical setting. Outcomes to be assessed include pain, function, activity levels and healthcare resource use.

Articular cartilage lesions in the ankle can cause significant pain and loss of function for young to middle age adults. There are several treatment options for symptomatic articular cartilage injuries depending on a patient's age, symptoms and duration of complaints in addition to the size and condition of the lesion. DeNovo NT Natural Tissue Graft is comprised of fresh particulated juvenile cartilage pieces that are secured inside articular cartilage lesions using fibrin adhesive. DeNovo NT Graft was developed due to the current need for expanded treatment options for the treatment of cartilage lesions, especially large lesions.

This post-market, multicenter, longitudinal data collection study was established to collect clinical outcomes of subjects implanted with DeNovo NT Graft. Data may be obtained either retrospectively or prospectively from patients implanted or to be implanted with DeNovo NT Graft for the treatment of lesion in the ankle. Data to be collected include details of the operative procedure as well as subject pain, function, activity levels, and healthcare resource use through a five year post-operative follow-up period.

Eligibility Criteria:
Potential subjects are screened for study entry based on a preliminary review of the inclusion and exclusion criteria as it applies to their pre-operative status (unless otherwise noted).

Inclusion Criteria:

* Has an articular cartilage lesion(s) in the ankle for which arthroscopic or surgical intervention with DeNovo NT Graft is warranted or has had prior treatment with DeNovo NT Graft for an articular cartilage lesion(s) in the ankle
* Has voluntarily signed the IRB approved informed consent
* Is of stable health and is able to undergo surgery
* Is male or female over the age of 18 at the time of consent
* Is physically and mentally willing and able to comply with post-operative rehabilitation and routinely scheduled clinical visits.

Exclusion Criteria:

* Displays a high surgical risk as determined by the investigative surgeon
* Is pregnant or breast-feeding
* Has a clinically diagnosed autoimmune disease
* Has an active joint infection or history of chronic joint infection at the surgical site
* Has medical history that would likely make the subject unreliable for the study, or any combination of variables in the investigator's judgment that should exclude a potential subject
Comparison of the Effect of Supine and Prone Position on the Ultrasonographic Airway Measurements

The aim of this study is to compare the preoperative and postoperative ultrasonographic measurements of patients undergoing in the prone position and the change in upper airway edema.

The secondary aim of the study is to investigate the relationship between OSAS risk levels determined by the STOP-BANG score in the preoperative period of the patients participating in the study, and airway ultrasound measurements and postoperative critical respiratory events in the preoperative and postoperative period.


Eligibility Criteria:
Inclusion Criteria:1-American Society of Anesthesiologists Physical Status Classification (ASA) I-II-III-IV risk group who will undergo Percutaneous Nephrolithotomy surgery

Exclusion Criteria:

1. prone position contraindications
2. history of maxillofacial deformity, tumor or trauma,
3. difficult airway history
4. decompensated cardiac, respiratory, hepatic, renal diseases
5. cervical spine fracture
6. Patients refusal -
Study of Low-Dose Cytarabine and Etoposide With or Without All-Trans Retinoic Acid in Older Patients Not Eligible for Intensive Chemotherapy With Acute Myeloid Leukemia and NPM1 Mutation

This is a randomized, Phase-III, two-arm, open-label, multi-center study in adult patients with AML and NPM1 mutation ineligible for intensive chemotherapy.

Sample size: 144 patients

Investigator's sites: 50-55 sites in Germany and Austria (2-10 patients per trial site are expected to be included into the trial)

Estimated treatment duration of an individual patient: 8 months (Follow-Up period per patient will last additional 2 years)


Eligibility Criteria:
Inclusion Criteria:

* Patients with confirmed diagnosis of acute myeloid leukemia according to the World Health Organization (WHO) classification (including de novo AML, t-AML and s-AML)
* Presence of NPM1 mutation as assessed in one of the central AMLSG reference laboratories.
* Age \> 60 years. There is no upper age limit.
* No prior chemotherapy for leukemia except hydroxyurea to control hyperleukocytosis if needed for up to 10 days during the diagnostic screening phase.
* Signed written informed consent
* Men must give their informed consent that they do not father a baby and must use a latex condom during any sexual contact with women of childbearing potential, even if they have undergone a successful vasectomy. (while on therapy and for 3 month after the last dose of chemotherapy)
* WHO performance status ≤ 3
* Patients not eligible for intensive chemotherapy according to at least one of the following criteria

  * HCT-CI Score \>2
  * Patient's decision
  * age ≥ 75 years

Exclusion Criteria:

The presence of any of the following will exclude a patient from study enrollment:

* All other AML subtypes, in particular those AML with other recurrent genetic changes (according to WHO 2008):

  * AML with t(8;21)(q22;q22); RUNX1-RUNX1T1
  * AML with inv(16)(p13.1q22) or t(16;16)(p13.1;q22); CBFB-MYH11
  * AML with t(15;17)(q22;q12); PML-RARA (or other translocations involving RARA)
  * AML with t(9;11)(p22;q23); MLLT3-MLL (or other translocations involving MLL)
  * AML with t(6;9)(p23;q34); DEK-NUP214
  * AML with inv(3)(q21q26.2) or t(3;3)(q21;q26.2); RPN1-EVI1
* No consent for registration, storage and processing of the individual disease-characteristics and course as well as information of the family physician and all other treating physicians about study participation
* Bleeding disorder independent of leukemia
* Uncontrolled infection
* Known positive for HIV, HBV or HCV
* Organ insufficiency (creatinine \>1.5x upper normal serum level; bilirubin, AST or ALP \>2.5x upper normal serum level, not attributable to AML; heart failure NYHA III/IV; severe obstructive or restrictive ventilation disorder)
* Severe neurological or psychiatric disorder interfering with ability of giving an informed consent
* Patients with a "currently active" second malignancy other than non-melanoma skin cancers. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse within one year.
Efficacy and Safety of Early TIPS (Transjugular Intrahepatic Portosystemic Shunts) in the Management of Cirrhosis With Recurrent Ascites.

All consecutive patients with cirrhosis of liver who satisfy the criteria will be included and will be evaluated clinically along with all routine investigations and standard medical therapy will be continued among these patients. The patients between 18-60 yrs of age (cirrhosis diagnosed on the basis of clinical, biochemical, fibroscan \& imaging.) , with ascites and HVPG (Hepatic Venous Pressure Gradient) \>12, with 2 or more large volume paracentesis in last 3 month . CTP ≥ 7-13 will be considered for the study.

At baseline, a complete history of the cause of cirrhosis of liver with clinical and physical examination, a record of demographic profile, standard of care biochemical investigations would be done.

In this study patients who satisfy the inclusion and exclusion criteria as mentioned below will be enrolled to receive either standard medical therapy with Large volume paracentesis and albumin infusion or to be randomised to receive TIPS (Transjugular Intrahepatic Portosystemic Shunt).

The patients in group A will be given standard medical therapy only included as per requirement nutritional therapy (high calorie intake- 2400 Kcal/ day) as and when required Large Volume Paracentesis (LVP) and albumin infusion and diuretics.


Eligibility Criteria:
Inclusion Criteria:

1. Liver Cirrhotics between 18-60 yrs of age (cirrhosis diagnosed on the basis of clinical, biochemical, fibroscan \& imaging)
2. Recurrent ascites (2 or more large volume paracentesis in last 3 month) on maximal tolerated diuretic dose.
3. Diuretic intractable ascites ( developing AKI/ hyponatremia (Na-\<130 , hypo/ hyperkalemia (\<3.5 , \>5.5), who will respond to withdrawal of diuretics
4. HVPG \>12 mm Hg
5. CTP ≥ 7-12
6. Patient is willing and able to comply with all study protocol requirements, including specified follow-up and testing.

Exclusion Criteria:

1. Hepatic or extra hepatic Malignancy-HCC, PVT
2. MELD (Model for End Stage Liver Disease) \> 18
3. Post TIPS (Transjugular Intrahepatic Portosystemic Shunt), Shunt surgery
4. LVP (Large Volume Paracentesis) \>3/month
5. Acute kidney injury (Sr.Cr\>2mg/dl)

5) CKD (Chronic Kidney Injury) 6) Previous hepatic encephalopathy 7) Acute on chronic liver failure 8) Active infection 9) Active alcohol intake 10) Left Ventricular systolic dysfunction/ overt CCM 11) PPH (Portopulmonary Hypertension) 12) Pt on mechanical ventilation 13) Patient in ICU/ any acute illness 14) Pregnant lady 15) SBP (Spontaneous bacterial Peritonitis)
CTC Pancreatic Adenocarcinoma

Proportion of circulating tumor cells (CTC) in the postoperative phase after curative tumor removal of pancreatic cancer will be determined and correlated to the accordance of anesthesia (desflurane versus propofol)

This prospective, randomized study will be conducted over a 36-month period to investigate whether commonly used anesthetics (volatile versus intravenous) have an effect on the changes or occurrence of CTC in patients suffering from primary pancreatic cancer undergoing curative surgery. The specific research question is if there are changes of the CTC count in the postoperative phase in the desflurane group (intervention) compared to the propofol one (control). A secondary question is if these changes can be correlated to tumor outcome.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 85
* ASA I-III ( American Society of Anesthesiologists)
* Resectable pancreatic adenocarcinoma
* Primary surgery
* No neoadjuvant therapy
* Written informed consent

Exclusion Criteria:

* Metastatic disease
* Other than primary surgery (recurrence, reconstruction)
* Pre-operative chemotherapy
* Chronic opioid use
* Known hypersensitivity or suspected allergy to propofol, soya or egg proteins
* Known hypersensitivity to volatile anaesthetics (malignant hyperthermia)
* Pregnancy
* Breast feeding
* Enrolment in any other clinical trial during the course of this trial, 30 days prior to its beginning or 30 days after its completion
Tolerability and Pharmacokinetics of Iloperidone in Adolescent Patients

Tolerability, undertstanding of the action of the drug in the body, and understanding the effect of the drug in adolescent patients needing treatment with an antipsychotic medication


Eligibility Criteria:
Inclusion Criteria:

* males or females 12-17 years of age.
* in a stable housing situation with a guardian/parent who can encourage compliance with the study protocol.
* with diagnosis of disorder requiring treatment with an antipsychotic agent.
* having a Children's Global Assessment of Severity Scale (CGAS) of 41 or greater.
* Heart rate \</=100 beats per minute and \>/= 50 beats per minute.

Exclusion Criteria:

* Patients with mild, moderate or severe mental retardation (i.e., documented IQ \<70), do not have the capacity to assent, cannot understand the informed consent, or participate fully in the assessments.
* Hospitalized due to suicidal ideation or suicidal behavior, history of suicidal ideation within 6 months prior to screening, history of suicidal behavior within 2 years prior to screening.
* Pregnant, females who can become pregnant and lactating females.
* Known hypersensitivity to iloperidone and to related drugs.
* Clinical conditions (Neurological, metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal or urological), which may pose significant risk to patients or impair reliable study participation.
* Clinically unstable cardiac disease, structural cardiac abnormalities, congential long QT syndrome, clinically significant ECG abnormalities at screening (PR interval \>240 ms, QTcF \>450 ms, QRS duration \>/= 100 ms) or arrhythmias.
* Syncope, near syncope, or palpitations. Other protocol-defined inclusion/exclusion criteria may apply.
Different Doses of vPDT in the Treatment of cCSC

This is a prospective, randomized and controlled clinical trial of photodynamic therapy (PDT) for chronic central serous chorioretinopathy (CSC). The patients who met the inclusion criteria were randomly divided into 50% dose PDT treatment group and 70% dose PDT treatment group. The primary treatment success rate and adverse event rate of the two groups were compared by optical coherence tomography (OCT), and then the best PDT treatment scheme for chronic CSC was summarized.


Eligibility Criteria:
Inclusion Criteria:

* 18-75 years old, regardless of gender;
* Meet the diagnostic criteria of central serous chorioretinopathy;
* The course of CSC (subject to the symptoms of this disease) is more than 3 months;
* Patients with simultaneous diseases of both eyes were included in those with more subretinal fluid.

Exclusion Criteria:

* macular neuroretinal detachment caused by rhegmatogenous retinal detachment, uveitis, age-related macular degeneration, polypoid choroidal angiopathy and other fundus diseases;
* a previous history of PDT treatment;
* systemic hormone or local hormone nasal spray is being used, or hormone is stopped for less than 3 months.
Improving Women's and Children's Health Via Biobanking and Electronic Registry

Pregnancy related diseases and exposures in pregnancy are known risk factors for future disease. For example, women with a history of preeclampsia (a hypertensive disorder in pregnancy) and children born to these women are at increased risk of cardiovascular disease later in life. Yet, the mechanisms by which these long term health risks occur are unknown. Clearly, this presents a significant public health hazard as preventative and therapeutic interventions to block these pregnancy related diseases are limited. Current barriers to studying these long-term mechanisms in existing cohorts include 1) lack of paired long-term mother-child data, 2) lack of uniformly collected biosamples and 3) challenges in integrating data from multiple sources and institutions. In particular, data and biosample collection from rural and minority populations present significant challenges. The objective of the iELEVATE proposal is to expand and diversify a current biobank to accelerate long-term translational mechanistic and outcomes research in the vulnerable pregnancy population. We will accomplish this by establishing a widely available biorepository that will collect a first trimester blood and urine sample from pregnant women with a clinical data warehouse and e-registry to support long-term prospective cohort studies.


Eligibility Criteria:
Inclusion Criteria:

Pregnant women in their first trimester (less than 14 weeks) and have the capacity to provide informed consent are eligible to participate

Exclusion Criteria:

Under 18 years old, known non-viable pregnancy at time of consent,inability to provide informed consent and diagnosis of a known infectious disease.
Mepivacaine vs. Bupivacaine Spinal Anesthetic in Total Knee Arthroplasty

The purpose of this study is to determine if a shorter-acting spinal anesthetic called mepivacaine has advantages over a longer-acting medication called bupivacaine.

Different medications last for different amounts of time and can be changed depending on the length of the procedure. A short acting spinal is generally used for procedures lasting less than 90 minutes. A longer acting medication would be any that lasts longer than 90 minutes. These medications not only block the signals that travel along the pain nerves, they also prevent the signals that tell the patients muscles to move. This means that after a total knee replacement a patient may delayed in their ability to get up and start walking early after surgery. Walking early in the recovery has been shown to decrease the rate of pulmonary embolism and death. Ambulating early is also important to prevent loss of strength, constipation, pneumonia and urinary retention.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients undergoing primary total knee arthroplasty

Exclusion Criteria:

* Chronic opioid users
* Unable to give informed consent
* Forego the use of a foley catheter
* Those with hypersensitively to amide local anesthetics or opioids
* Those with contraindications to spinal anesthesia
* Conversion to general anesthesia will be excluded.