cyrilzakka/clinical-trials huggingface dataset:
VentaProst Versus Conventionally-Administered Aerosolized Epoprostenol in Patients Undergoing Cardiac Surgery With CPB

The purpose of the Phase 2a study is to: 1) demonstrate that the estimated VentaProst dose is safe and equivalent in effect to a dose administered via epoprostenol aerosolization by the current off-label-use practice; and 2) demonstrate that an optimum effect can be rapidly obtained with VentaProst titration.

Part I:

This part of the study is designed to demonstrate the dose equivalence between off-label aerosolized epoprostenol and VentaProst using a patient's hemodynamic parameters.

Part II:

This part of the study is designed to establish a dose response relationship of VentaProst to hemodynamic effect by dose escalation in patients who have had cardiac surgery with CPB.

Eligibility Criteria:
Inclusion Criteria:

1. Women and Men 18 to 75 years of age
2. Provide written informed consent
3. Willing and able to comply with all aspects of the protocol
4. For patients in Part I:

   1. Undergo cardiac surgery on CPB
   2. Clinically require treatment with and receive aerosolized epoprostenol
   3. Demonstrate a clinically meaningful hemodynamic response to aerosolized epoprostenol
5. For patients in Part II:

   1. Undergo cardiac surgery with CPB
   2. Have perioperative pulmonary hypertension
   3. Clinically require treatment with inhaled epoprostenol

Exclusion Criteria:

1. Current smoker (i.e., within the last 30 days)
2. Emergency operative status
3. Upper and/or lower respiratory tract infection within four weeks of screening
4. Contraindication to transesophageal echocardiogram (TEE) including esophageal disease or unstable cervical spine
5. Renal or severe hepatic impairment
6. Thromboembolic disease treated with anticoagulant therapy
7. Bleeding disorders
8. Significant restrictive or obstructive lung disease
9. History of concurrent malignancy or recurrence of malignancy within two years prior to Screening
10. History of a diagnosis of drug or alcohol dependency or abuse within approximately the last three years
11. Recent history of stroke or transient ischemic attack
12. Significantly abnormal laboratory tests at Screening
13. Pregnant or breastfeeding
14. Treatment with an investigational drug, biologic, or device within 30 days
15. Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the Investigator or Sponsor, would make the patient inappropriate for entry into this trial
16. Any condition where aerosolized epoprostenol is contraindicated
17. Known allergy or sensitivity to epoprostenol, any of its ingredients, or the diluent
An Ascending Dose Study of PIT565 in Participants With Systemic Lupus Erythematosus (SLE).

The purpose of the study is to determine the safety, tolerability, and pharmacokinetics of PIT565 in participants with SLE

This is an open-label, ascending dose, uncontrolled study in participants with SLE systemic lupus erythematosus (SLE). PIT565 will be administered subcutaneously (s.c.) following premedication.

Up to 8 cohorts are planned. Every cohort will have 3 sentinel participants and, depending on safety as well as observed biological activity, may have up to 3 additional optional participants (up to 6 participants per cohort). The decision to escalate the dose from one cohort to the next will be based both on safety and PD data. After the identification of a dose level that has been declared safe and has induced predefined B cell depletion in 100% of the participants (candidate dose level), the cohort from this candidate dose level can optionally be enriched with 6 additional participants (up to a total of 12 participants).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of SLE according to the 2019 ACR/EULAR criteria
* Documentation of SLE autoantibodies
* Active SLE disease, as demonstrated by a SLEDAI-2K ≥ 4 at screening
* Failure to respond to standard-of-care medicines for the treatment of SLE as detailed in the protocol
* Immunization against pneumococcus, influenza, and COVID-19

Exclusion Criteria:

* Severe SLE-related organ damage dysfunction or life-threatening disease at screening.
* Any acute, severe lupus-related flare during screening that needs immediate treatment such as acute CNS lupus (e.g., psychosis, epilepsy) or catastrophic antiphospholipid syndrome.
* Presence of severe lupus kidney disease as defined by worsening proteinuria or estimated glomerular filtration rate (eGFR) which in the opinion of the Investigator requires immune-suppressive induction or maintenance treatment at screening.
* History or current diagnosis of ECG or cardiac abnormalities indicating a significant risk of safety for participants.
* Use of prohibited medication defined in the protocol.
* Clinically significant active, opportunistic, chronic or recurrent infection (including, HIV, HBV, HCV) confirmed one month prior to or during screening.
* Serious medical illness likely to interfere with participation in this clinical study.
* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant from menarche until becoming post-menopausal, unless they are using highly effective methods of contraception

Other protocol defined inclusion/exclusion criteria may apply.
Neurodynamic Intervention in Fibromyalgia

Fibromyalgia is a chronic illness characterised by persistent,widespread muscle pain with generalised hyperalgesia and allodynia. It can be accompanied by other concomitant symptoms like fatigue, sleep disturbances, musculoskeletal disorders, distress and psychological disorders. This condition is very prevalent. It has been reported to be about 2-5% of the general global population.

Fibromyalgia have been reported to have neurodynamic disorders. The purpose of this prospective study was to examine the combined effects of soft tissue mobilization and nerve slider neurodynamic technique on pain and pressure sensitivity in women with fibromyalgia.

Fibromyalgia affects women nine times more than men.The pathophysiology of fibromyalgia is being studied nowadays in order to understand the mechanisms implicated in it.

The treatment propose in this study is a neurodynamic intervention. Neurodynamics is the term used to describe the integration of the morphology, biomechanics and physiology of the nervous system.

Eligibility Criteria:
Inclusion Criteria:

* Women diagnosed with Fibromyalgia attending to the Fibromyalgia Association of Granada.
* Women who can complete the assessment battery of tests at the beginning and at the end of the study
* Female sex.

Exclusion Criteria:

* Male sex.
* Auditive and visual disturbances.
* Cognitive problems.
* Psychiatric pathology.
* Traumatic pathology of the hand.
Comparative Evaluation of Pulpal Anaesthetic Efficacy of Different Anaesthetic Solutions for Inferior Alveolar Nerve Block in Patients With Symptomatic Irreversible Pulpitis

Pulpal and periapical inflammation and infection can cause tissue pH in the affected region to be lowered which results in less penetration of anesthetic solution in the nerve membrane and hence delays the onset of anesthesia. So, the purpose of this study was to compare the pulpal anesthetic efficacy of lidocaine, articaine, mepivacaine for inferior alveolar nerve block (IANB) in patients with irreversible pulpitis (IP). One hundred and twenty adult patients with IP concerning mandibular molars randomly received IANB with either of the three solutions: 2% lidocaine with epinephrine; 4% articaine with epinephrine; 3% plain mepivacaine. Pain during the endodontic treatment was assessed using a visual analog scale (Heft-Parker VAS). Endodontic treatment was initiated. Success was defined as no or mild pain (pain score≤54mm on Hp VAS) during access preparation and root canal instrumentation. The anesthetic success rates were analyzed with the chi-square test.


Eligibility Criteria:
Inclusion Criteria:

* active pain in a mandibular molar
* prolonged response to cold testing with an ice stick and an electric pulp tester
* absence of any periapical radiolucency on radiographs, except for a widened periodontal ligament
* vital coronal pulp on access opening and ability to understand the use of pain scales

Exclusion Criteria:

* known allergy, sensitivity, or contraindications to any opioid or nonopioid analgesic including aspirin or NSAIDs
* history of active peptic ulcer within the preceding 12 months
* history of bleeding problems or anticoagulant use within the last month
* patients who were pregnant or breast-feeding
* a history of known or suspected drug abuse
* patients who had taken NSAIDs within 12 h before administration of the study drugs
Validity and Reliability of Modified Box and Block Test and Targeted Box and Block Test in Patients With Stroke

The aim of our study is investigated validity and reliabilty of Modified Box and Block Test and Targeted Box and Block Test in patients with stroke.

Fifty patients with stroke will included in the study. Box and Block Test, Modified Box and Block Test, Targeted Box and Block Test, 9 Hole Peg Test, Fugl-Meyer Assessment of the upper extremity will used to assess upper extremity. To evaluate validity between Modified and Targeted Box and Block Tests and Box and Block Test, 9 Hole Peg Test, Fugl-Meyer Assessment will used to correlation analysis tests. The investigator will evaluate after one week to test-retest reliability to patients. Other pyhsiotherapist will evaluate to patients inter-rater reliability.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with stroke and in the chronic phase (having been diagnosed with stroke at least 6 months ago),
* Over 18 years old,
* Mini Mental Test score ≥ 24 points,
* Able to grasp and release a 2.5 cm cube on both upper extremities,
* Brunnstrom Upper Extremity Staging ≥ 3
* Modified Ashworth Scale ≤ 2,
* Able to sit independently in a chair for 2 minutes

Exclusion Criteria:

* Having a neurological disease other than stroke
* Have had surgery in the last 6 months
* Severely affected upper extremity
* Uncooperative with physiotherapist
* Patients with neglect, aphasia and hemianopsia
MRI in High-Grade Glioma Patients Undergoing Chemoradiation

The purpose of this research study is to see if investigators can predict how brain functioning changes after radiation treatment based on PET scans and blood tests. Most participants experience at least mild decreases in their memory or attention after radiation therapy. Investigators hope that PET scans, lumbar puncture, and blood tests might help investigators predict who might have larger changes in their brain function after radiation.

Primary Objective: To determine the feasibility of interim PET-MRI in high-grade glioma patients undergoing chemoradiation by quantifying the proportion of high-grade glioma patients who are alive at 4 months post-radiation treatment and who have completed two PET scans and abbreviated cognitive testing pre-radiation treatment and at 4 months post radiation treatment.

Secondary Objectives

* To determine by machine learning if early changes on FDG-PET correlate with cognitive decline after radiation treatment. Cognitive impairment will be defined as a 1 standard deviation decline on any test.
* To determine if baseline serum or cerebrospinal fluid markers or the change from baseline to 1-month are associated with patients with cognitive decline at 4-months after radiation treatment (defined as a 1 standard deviation decline on any test) compared to those without decline.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed diagnosis of high grade glioma (grade III or IV) or WHO grade II glioma, IDH wildtype (molecular glioblastoma multiforme \[GBM\]).
* ≥18 years of age.
* ECOG performance status of 0 to 3
* Anticipated to receive 6 weeks of chemoradiation

Exclusion Criteria:

* Does not speak or read English
* Unable to participate in cognitive testing due to aphasia or other severe cognitive impairment as determined by the PI, or Dr. Cummings or her designee.
* Unable to give informed consent
* Past medical history of any kind of dementia or diagnosed with mild cognitive impairment prior to diagnosis with their brain tumor
* Unable to safely fast for 8 hours prior to bloodwork or 6 hours prior to PET scan
* Currently taking cognition-enhancing medications including:

  * Donepezil
  * Memantine
  * Armodafinil
  * Methylphenidate
* Pregnant or nursing mothers.
* Patients taking blood thinners will be excluded from the optional Lumbar Puncture only, they are eligible for participation in the main study-provided they meet inclusion/exclusion criteria
A Study of the Effect on Oro-dental Complications of Intensity Modulated Radiotherapy (IMRT) Versus Conventional Radiotherapy in Patients With Cancer of the Head or Neck

Study to investigate the effect of two types of radiotherapy on saliva: IMRT versus conventional radiotherapy.

In each group, one part will receive normal dental preventive treatment. The other part will use products for treatment of dry mouth (Biotene gamma).

Both anorganic and organic components of the saliva will be studied at different time points, combined with bacterial swabs.


Eligibility Criteria:
Inclusion Criteria:

* \> 18 years old
* Cancer of head or neck

Exclusion Criteria:

-
Platelet Reactivity After CABG

Patients who have a heart attack are regularly treated with either clopidogrel or ticagrelor. In a large clinical trial, treatment with ticagrelor before coronary bypass surgery (CABG) was associated with a lower risk of death than treatment with clopidogrel. The reason for this difference cannot be explained on the basis of the study. One possible explanation is that the reversible binding of ticagrelor is advantageous because when new platelets are released, they are inhibited by the drug. Because clopidogrel binds irreversibly it cannot redistribute. The investigators will recruit patients who are scheduled for surgery after an acute coronary syndrome who have been treated with either ticagrelor or clopidogrel. After the patient provides informed consent, the investigators will review their medical record,record information and on the day after surgery the investigators will take one sample of blood. That blood will be analyzed for evidence of platelet activation (platelet microparticles, and platelet-leukocyte aggregates), the reactivity of young platelets, and the concentration of inflammatory cytokines. The investigators hypothesize that the evidence of platelet activation (platelet microparticles and platelet-leukocyte aggregates) and the reactivity of young platelets will be less in patients who have been treated previously with ticagrelor.


Eligibility Criteria:
Inclusion Criteria:

* Acute coronary syndrome, CABG, within 48 hours of last dose of clopidogrel or ticagrelor, treatment with aspirin

Exclusion Criteria:

* Treatment with an antiplatelet agent other than aspirin, clopidogrel, or ticagrelor, Acute or chronic hematologic disorder including a preoperative Hgb less than 10 g/dl or platelet count less than 100,000/mm3, Moderate or severe renal insufficiency (glomerular filtration rate less than 60 ml/min), Active infection, Active malignancy, Unable/unwilling to provide informed consent
Bioavailability Study of SPARC001(Study 1) in Healthy Adult Volunteers

The objective of the study is to determine the relative bioavailability, safety and tolerability of SPARC001 and Reference001 in healthy, adult, male and female subjects


Eligibility Criteria:
Inclusion Criteria:

1. Adult, male and female volunteers, 18 to 55 years of age, inclusive, at first Check-In Visit;
2. Body mass index (BMI) ≥18 to ≤30 kg/m2 and total body weight \>50 kg (110 lbs) at Screening
3. All female subjects must have a negative serum pregnancy test at Screening and at each Check-in Visit
4. Medically healthy on the basis of medical history

Exclusion Criteria:

1. Females who are pregnant, lactating, or likely to become pregnant during the study
2. Life-time history and/or recent evidence of alcohol or drug/substance abuse disorder
3. Subjects with history or presence of significant cardiovascular, pulmonary, hepatic, gallbladder or biliary tract, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychiatric disease, or active sexually transmitted disease
4. Subjects determined by the investigator to have any medical condition that could jeopardize their health or prejudice the results
Iron Supplementation in Inflammatory Bowel Disease (IBD) Patients With Chronic Fatigue

A phase 2, randomized, placebo controlled trial evaluating the effects of n intravenous iron supplementation on chronic fatigue in IBD patients with controlled disease.

The study will evaluate a 6 months therapy with intravenous ferric carboxymaltose.

Patients will undergo a 2-5 days screening period and then will be treated every 4 weeks with iron supplementation/placebo.

At every visit, hematology and blood iron levels will be evaluated. Treatment will be temporarily stopped in case of either Hemoglobin levels above 16 g/dl or ferritin above 800 ng/ml (level decreased to 500 ng/ml in case of Transferrin-Iron Saturation Percentage above 50%).

Study team will be composed of blinded and unblinded personnel and dedicated infusion devices will be used to ensure the double blinding.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Ulcerative Colitis or Crohn's Disease established at least 6 months prior to Day 1 by endoscopy and/or imaging
* At least 6 months of clinical remission (Harvey Bradshaw Index ≤5; Mayo clinical score ≤ 2)
* Therapy with mesalamine, immunosuppressors or anti-tumor necrosis factor alpha (TNFα) at stable doses for at least 3 months prior enrollment; steroids are not permitted from 6 months prior baseline
* Chronic fatigue symptoms (MFI-20\>13)
* Iron deficiency: ferritin \< 100 microg/l or \< 300 microg/l in case of Transferrin-Iron Saturation Percentage (TSAT) \<20%
* Women of childbearing potential must have a negative serum pregnancy test before enrollment.
* Able and willing to provide written informed consent

Exclusion Criteria:

* Known hypersensibility to active principle or excipients
* Pregnant or lactating women
* Clinically active IBD (Harvey Bradshaw Index \>6; Mayo clinical score \>3 or C-Reactive Protein \>2.5 mg/L
* Renal failure (eGFR\<60)
* History of adrenal insufficiency
* History of autoimmune diseases
* History of malignancies
* Depression
* Any current or recent signs or symptoms of viral infectious diseases
* Recent psycho-traumatic events
* Hemoglobin levels \< 12.5 g/dl (men) or \<11.5 g/dL (women)
Lactoserum (Dermacyd Femina®) and Prevention of Recurrence of Bacterial Vaginosis

The purpose of this study is to demonstrate if the use of Dermacyd can avoid the recurrence of bacterial vaginosis after three months of the standard treatment.


Eligibility Criteria:
Inclusion Criteria:

* Women in reproductive age
* Confirmed cure of bacterial vaginosis after treatment with oral metronidazole.
* Vaginal bacterioscopic examination negative for candida and trichomonas.

Exclusion Criteria:

* Pregnant or breastfeeding women
* Allergy to dermacyd

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
A Pharmacokinetic/Pharmacodynamic Inhaler Comparison Study in Healthy Volunteers

A 2-group healthy volunteer study to compare a breath actuated inhaler (BAI) and a pressurised metered dose inhaler (pMDI) with and without spacer.

Group 1 will assess pharmacokinetics, Group 2 will assess pharmacodynamics. PK interim analysis to determine requirement for PK extension.

Group 1 (PK) blood sampling and safety assessments up to 36 hours post-dose for 3 study periods. Results from PK stage will determine if Group 2 (PD) is required. Group 2 (PD) will assess LABA only effects (as confirmed in interim analysis).

Group 2 (PD) to include 2 overnight stays for 5 study periods. Volunteers will receive a single dose of study medication, with discharge on Day 2.

Study treatments are fluticasone/formoterol BAI, fluticasone/formoterol pMDI with/without spacer, formoterol alone without spacer, and low dose fluticasone/formoterol without spacer.

Volunteers will undergo blood sampling, and safety assessments up to the morning of discharge. An inspiratory flow recorder (IPR) will be used for training and to monitor inspiratory flow rate, inhaled volume and inhalation technique.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects aged 18 years or over.
* Healthy and free of significant abnormal findings as determined by medical history, physical examination, vital signs, laboratory tests and ECG.
* Normal lung function (FEV1 \>90% of predicted normal value).
* Demonstrate satisfactory technique in the use of the study drug devices.
* No use of steroid medication (systemic or topical) within 8 weeks prior to study screening.

Exclusion Criteria:

* Subjects who use any asthma medication or are knowingly regularly exposed to asthma medication.
* Any history of drug or alcohol abuse.
* Any history of conditions that might interfere with drug absorption, distribution, metabolism or excretion.
* History of asthma, COPD, or other bronchial or lung diseases.
* User of steroid medication (systemic or topical) within 8 weeks prior to study screening.