cyrilzakka/clinical-trials huggingface dataset:
Compassionate Use of Opaganib in Patients With Coronavirus Disease 2019 (COVID-19)

Shaare-Zedek Medical Center is a tertiary academic hospital in Jerusalem, Israel. On March 2020, a dramatic increase in the number of COVID-19 cases were diagnosed in Jerusalem. RedHill Biopharma, Ltd. offered opaganib under compassionate use for the treatment of COVID-19 patients. Eligible patients were those hospitalized with COVID-19 confirmed by a reverse-transcriptase-polymerase-chain-reaction assay. Patients received opaganib and Standard of Care. For the purpose of this study, the opaganib and Standard of Care patient group was compared to a group of patients that received only Standard of Care. Opaganib is an investigational drug under development and not approved for commercial distribution.

In this observational study, the two cohorts were assigned retrospectively. Patients either received opaganib and Standard of Care (SOC) or SOC only. All patients were defined by the treating physicians at baseline as severe COVID-19. For the control cohort, IRB approval was granted to collect de-identified data. Both cohorts had similar median age and similar rates of diabetes, hypertension and obesity.

The two treatment groups, opaganib and SOC vs. SOC were then analyzed for their clinical outcomes including baseline characteristics.

Eligibility Criteria:
Inclusion Criteria:

* hospitalized patients with COVID-19 confirmed by a reverse-transcriptase-polymerase-chain-reaction assay
* patients with severe disease requiring oxygen support via high-flow nasal cannula
* signed informed consent
* acceptable liver and renal function tests
* acceptable hematologic status

Exclusion Criteria:

* pregnant or nursing women
* patients on warfarin, apixaban, argatroban or rivaroxaban
* patients with New York Heart Association Class III or IV cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, or evidence of ischemia on ECG
Neuromuscular Blockade for Post-Cardiac Arrest Care

The main purpose of this study is to evaluate if neuromuscular blockade improves lactate clearance (and preliminary secondary clinical outcome measures) as compared to usual care in post-cardiac arrest patients undergoing targeted temperature management.

Out-of-hospital cardiac arrest (OHCA) occurs in more than 300,000 patients in the United States each year with an estimated mortality of greater than 90%. Unfortunately, we currently have little to offer in terms of treatment other than supportive care for the post-cardiac arrest patient. Neuromuscular blockade (NMB) is sometimes utilized in post-arrest patients particularly for the prevention of shivering. However, usage of NMB remains controversial and current American Heart Association (AHA) recommendations are to minimize utilization. Recent prospective randomized trials in patients with acute respiratory distress syndrome suggest a mortality benefit from NMB and an excellent safety profile. Furthermore, observational trials in both sepsis and post-cardiac arrest show that the use of NMB is associated with improved survival. Given this, we hypothesize that continuous NMB will be beneficial in post-arrest patients. In order to test this hypothesis, we propose a multi-center, randomized, open-label, phase II trial in post-CA patients comparing sustained NMB administration for 24 hours to standard of care after return of spontaenous circulation (ROSC). We will enroll adult, comatose OHCA patients with ROSC and will utilize an already existing clinical trials network for the completion of the study. Patients will be randomized to receive either rocuronium for 24 hours or to receive placebo with usual care. Previous data from our group has suggested that lactate levels in the post-arrest patient are a good surrogate marker for mortality. We have therefore chosen to utilize lactate levels at 24 hours as the primary endpoint for the current trial. Secondarily we will evaluate clinical endpoints including length of stay (LOS), in-hospital mortality, and good neurological outcome. We will perform a sub-study of inflammatory markers and oxygen consumption.

Eligibility Criteria:
Inclusion Criteria:

* Adult (≥ 18 years)
* Cardiac arrest with sustained return of spontaneous circulation (ROSC)
* Comatose (i.e., not following commands) following ROSC
* Undergoing targeted temperature management (TTM)
* Time of enrollment ≤ 6 hours from initiation of targeted temperature management
* Serum Lactate ≥2

Exclusion Criteria:

* Pre-existing dementia, severe brain injury, or dependence on others for activities of daily living (i.e. a modified Rankin scale (mRS) score of 4 or higher)
* Traumatic etiology of the cardiac arrest
* Protected population (pregnant, prisoner)
Study of Factors of Genetic Susceptibility Associated to Severe Caries Phenotype

Alteration of the post- eruptive enamel microstructure due to a mutation of a gene coding for a matrix protein could increase the susceptibility of the enamel to caries after tooth eruption. To identify in young patients with severe caries incidence, the occurrence of mutations in several candidate genes which result in an alteration of the enamel microstructure that could explain the high caries susceptibility of the patient.

Although its prevalence has decreased dramatically in European countries, dental caries remains a burden for the society and especially for certain groups of the population. For example, 80% of the carious lesions are diagnosed in about 20% of the children. For years, the aetiology of this disease has been mainly related to environmental factors but recent data support the possibility of a human genetic contribution. Alteration of the post- eruptive enamel microstructure due to a mutation of a gene coding for a matrix protein could increase the susceptibility of the enamel to caries after tooth eruption. The main objective of this study will be to identify in young patients with severe caries incidence, the occurrence of mutations in several candidate genes which result in an alteration of the enamel microstructure that could explain the high caries susceptibility of the patient. With this aim, we will carry out a case- control multicentre European study on 250 young patients presenting several carious lesions and 160 young adults totally caries free. Patients with systemic or enamel pathologies such as amelogenesis imperfecta will not be included in the study. The study will consist of 2 visits, 1: inclusion and genetic test based on a salivary sample and 2: after 6 months, communication of the genetic test result to the patient and his parents. The main evaluation criteria will be the finding of a mutation on the candidates genes not resulting in an amelogenesis imperfecta phenotype but associated to a severe caries phenotype. If a direct relation between a mutation and a severe caries phenotype was shown, all the classical approaches, prevention protocols and treatments of caries would need to be reconsidered.

Eligibility Criteria:
Inclusion Criteria:

* Patients : presenting at least 3 active carious lesions aged 2 to 16 years old, written informed consent
* Volunteers : young adults 18 to 30 years old totally caries free

Exclusion Criteria:

* patients with systemic or enamel pathologies such as amelogenesis imperfecta
* osteogenesis imperfecta
* hypophosphatemia
* hypodermal dysplasia
* syndrome of Prader Willi
* Fluoroses
* toxic enamel dysplasia
* pregnancy or breast-feeding
* HYPOSIALORRHEA
* immunodepression status
* chronicle diseases
* anorexia or bulimia
Analgesic Effect of Subcostal TAP Block

The purpose of this study was to compare the analgesic efficacy of the ultrasound guided bilateral subcostal tap block with ultrasound guided bilateral posterior tap block for postoperative analgesia after laparoscopic cholecystectomy

After approval from Ethics Review Committee, patients were enrolled according to the inclusion and exclusion criteria. Informed written consent for inclusion in the study was taken and during the process,patients were explained about the NRS and other secondary objectives.

Blocks were performed under ultrasound guidance immediately after induction of anesthesia.For postoperative analgesia,patients were randomly allocated in two groups using draw/ballot method assigning patients to either of the S-TAP block group or P-TAP-block group. The patients and the staff providing postoperative care and the doctor assessing the pain after surgery were blinded to group assignment. Patients in both groups received standard of care analgesia during the post-operative period i.e., I/V Ketorolac 30mg every 8 hourly, I/V Tramadol 50mg every 8hourly and as per need basis, and I/V Paracetamol 1000mg every 6 hourly Subsequent surgical procedure was performed routinely. After completion of the surgery and emergence from anesthesia, patients were shifted to the Post Anaesthesia Care Unit, and time of arrival in recovery room was taken as 0-hour and noted. Assessment for outcome measures started in recovery room, and continued till 24 hours of the surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients age 18 to 60 years,American society of Anaesthesiology(ASA) class I and II, admitted electively for laparoscopic cholecystectomy

Exclusion Criteria:

* Patients with known allergies to local anesthetics, who were morbidly obese because of difficulty of ultrasound guided approaches for block or having hepato-splenomegaly or any known liver disease, and those whose laparoscopic procedure is converted to open cholecystectomy for any reason
Dental Pain Study of Analgesics in Patients Undergoing Molar Removal

* Accessing the efficacy and safety of pregabalin when used alone and in combo with acetaminophen in a dental pain model.
* To test whether pre-operative dose of pregabalin increases the time to significant post-operative pain (NRS ≥ 5), and hence time to first analgesia consumed post-operatively.

This is a 5 arm randomized, double-blind, parallel group, single-center, placebo-controlled study to evaluate the efficacy and safety of pregabalin-acetaminophen combination in the prevention and treatment of post-surgical dental pain in healthy patients.

Subjects in every treatment arm will receive a dose 60 min prior to surgery. It is not required to receive a post-operative dose if patient does not feel pain at a scale of NRS≥ 5. Dose 2 will be given post-surgically when patients report at least moderate pain on the categorical scale and a score of ≥5 on 0-10 PI-NRS. Subsequent to dose 2, patients can request rescue analgesic at any time.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are scheduled to undergo the surgical removal of up to 4 third molars of which at least 2 have to be mandibular molars with a difficulty rating of 4 or 5.
* Patient must have a negative urine drug screen for drugs of abuse (including tobacco) at screening and at the day of surgery.
* No alcohol for a minimum of 1 day prior to the surgery.

Exclusion Criteria:

* Patients should not be experiencing oral infections or symptoms of concomitant illness at the time of a scheduled surgery.
* Patients with a history of any type of malignancy within the past 5 years other than minor skin related cancers.
* Patients who currently have or have had a history of uncontrolled hypertension.
* Patients with a known allergy or hypersensitivity to any local anesthetic drug, NSAIDs, gabapentin or pregabalin;.
* Patients with conditions that affect the absorption, metabolism, or passage of drugs out of the body (e.g., sprue, celiac disease, crohn's disease, etc.)
Psychosocial Predictors of Poor Outcomes After a Knee Arthroplasty

The purpose of this study is to explore the association between the psychosocial variables: pain catastrophizing, fear of movement, coping skills, pain attitudes, anxiety and depression with postoperative outcomes (pain, health functioning, physical performance, and quality of life) after a knee arthroplasty (KA). The prevalence of KA has increased dramatically during the last two decades, its popularity can be attributed to its evident success regarding pain improvement, deformity correction and disability reduction in knee osteoarthritis subjects. However, only a third of the patients report no functional problems after surgery, the 20% of them are unsatisfied with its functional skills and around a 20% are experiencing pain, high disability degrees and a significant quality of life reduction. This results cannot be fully explained by mechanical processes, surgical procedures or surgery variations, but seems to be related to other psychological aspects. Chronic pain subjects often develop maladaptive thoughts and behaviours (i.e. pain catastrophism, kinesiophobia, activity avoidance) which contribute to make the subject suffer physically as well as emotionally, and affect on the intensity and persistency of pain.

This study is a single centre, prospective observational study of subjects undergoing primary KA. The study is designed and aimed to examine the relationship between postoperative psychosocial factors and the development of post-operative persistent pain and disability.


Eligibility Criteria:
Inclusion criteria:

1. To have sufficient Spanish or Catalan reading, writing and speaking skills to comprehend all explanations and to complete the assessment tools.
2. Be able to provide the informed consent.
3. Be scheduled to undergo in a total or unicompartimental knee arthroplasty.
4. Knee osteoarthritis diagnosis.
5. Patients 18 years old or more.

Exclusion criteria:

1. Patients scheduled to undergo in a total knee arthroplasty because of prostheses replacement, tumor, infection or fracture.
2. Patients scheduled to undergo in a bilateral total knee arthroplasty.
3. Patients that will need another total knee or hip replacement surgery in less than a year regarding the current intervention.
4. Patients with other pathologies with characteristic features of a central sensitization. (i.e. Fibromyalgia)
5. Co-existing other inflammatory or rheumatic conditions (i.e. rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus or ankylosing spondylitis)
6. Co-existing other mental condition and/or major depression.
Correlation Analysis of POD and pNCD in Elderly Patients With Gastrointestinal Neoplasms

This is a prospective cohort study to explore the differences of serum indicators between elderly gastrointestinal neoplasms patients with postoperative delirium (POD) who either develop or do not develop long-term postoperative neurocognitive disorders (pNCD).

The purpose of this study is to explore the differences of serum indicators between elderly gastrointestinal neoplasms patients with postoperative delirium (POD) who either develop or do not develop long-term postoperative neurocognitive disorders (pNCD).

Elderly gastrointestinal neoplasms patients aged 65 and above, undergoing surgical operations at Xuanwu Hospital, Capital Medical University, were selected. The serum indicators of all patients were measured before surgery, and neurocognitive function of all patients was assessed using the Montreal Cognitive Assessment (MoCA) within 1 week before surgery. General patient data such as sex, age, comorbidities, BMI, ASA classification, and MoCA scores were collected. Under routine anesthetic management of the Department of Anesthesiology and Surgical Operations at Xuanwu Hospital, endotracheal intubation general anesthesia was performed. Intraoperative monitoring included heart rate, blood pressure, pulse oximetry, and body temperature, with surgery and anesthesia times, and fluid balance recorded. The serum indicators of all patients were measured after surgery. Within 7 days post-surgery, delirium assessment was conducted using the Confusion Assessment Method (CAM), classifying patients into POD and non-POD groups. For the patients in the POD group, neurocognitive function was assessed at a period of time after surgery to determine the presence of pNCD, further dividing the POD group into pNCD and non-pNCD subgroups. The correlation between POD and pNCD was explored by comparing the changes of serum indicators before and after surgery in the pNCD and non-pNCD subgroups.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥65 years of age who have undergone surgical anesthesia of gastrointestinal neoplasms; Sign informed consent.

Exclusion Criteria:

* Inability to complete cognitive function assessment; Illiteracy, hearing impairment or visual impairment; He has a history of epilepsy, depression, schizophrenia, Alzheimer's disease and other psychiatric and neurological diseases.
A Study to Evaluate the Safety and Effectiveness of WF10 Given to Patients With Late-Stage HIV Disease

The purpose of this study is to see if it is safe and effective to give WF10 to adults with late-stage HIV disease. WF10 is suspected to help the immune system fight infection and slow HIV disease progression.

Patients are randomized to 1 of 2 treatment groups to receive 4 IV treatment cycles of either WF10 or control (physiological saline solution). Patients are monitored throughout the study for: a) clinical progression; b) number, duration, and cause of hospitalizations; c) quality of life; and d) density of CD38 antigen on CD8+ T cells. Patients receive treatment for 11 weeks but will continue to be followed for a maximum of 96 weeks. During the follow-up period, patients are evaluated initially at Week 18, then at Weeks 24, 36, and 48. If the study is continued beyond Week 48, follow-up visits are conducted at Weeks 72 and 96.

Eligibility Criteria:
Inclusion Criteria

Patients may be eligible for this study if they:

* Are HIV-positive.
* Have a CD4 cell count of less than 50 cells/mm3 within 14 days prior to study entry.
* Are at least 18 years old.
* Have received anti-HIV drugs at some time in the past.
* Agree to practice abstinence or use effective methods of birth control, including the pill, during the study.

Exclusion Criteria

Patients will not be eligible for this study if they:

* Are being treated for any form of cancer within 30 days of study entry.
* Have ever received an HIV vaccine.
* Have received steroids within 30 days prior to study entry. (Note: Testosterone is allowed.)
* Have received certain medications, including anti-HIV treatments that are not approved by the FDA.
* Have participated in another WF10 study.
* Have an illness or any condition that might exclude them from this study.
* Are pregnant or breast-feeding.
* Abuse drugs or medications.
* Received a blood transfusion within 45 days prior to study entry.
A Study to Evaluate the Effect of Danoprevir/Ritonavir on the Pharmacokinetics of Escitalopram and S-Demethylcitalopram in Healthy Volunteers

This single-arm, open-label, non-randomized study will evaluate the effect of danoprevir/ritonavir on the pharmacokinetics of escitalopram and S-demethylcitalopram in healthy volunteers. Healthy volunteers will receive oral doses of danoprevir/ritonavir and escitalopram. The anticipated time of the study is 6 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Adult healthy volunteers, aged 18 to 55 years, inclusive
* Body mass index (BMI) 18.0 to 32.0 kg, inclusive
* Absence of evidence of any active or chronic disease
* Non-smokers

Exclusion Criteria:

* Presence of any active or chronic disease
* Abnormal blood pressure
* Abnormal resting heart rate
* Abnormal ECG values
* History of any clinically significant cardiovascular or cerebrovascular disease
Cognitive Behavioral Therapy for Complicated Grief

The purpose of this study is to determine whether cognitive behavioral therapy (CG-CBT) for complicated grief is superior to wait list condition in patients with comorbid complicated grief. To evaluate the effect pre-post changes for patients in the CG-CBT-group will be compared to changes in the wait list group.


Eligibility Criteria:
Inclusion Criteria:

* age complicated grief diagnosis

Exclusion Criteria:

* acute suicidality
Whole Body Magnetic Resonance Imaging With Diffusion Weighted Imaging : Potential Role in Neurofibromatosis

Whole body MRI will be performed in patients with neurofibromatosis Type 1

PURPOSE 1:

To determine the total tumor load (neurofibroma) and to diagnose plexiform neurofibromas or malignant peripheral nerve sheath tumors. All patients will be scanned two years after the baseline whole body MRI to investigate to investigate the changes of total tumor load.

PURPOSE 2: added value of diffusion weighted imaging in diagnosis of high-risk neurofibromas

PURPOSE 3 : to determine the apparent diffusion coefficient of the malignant nerve sheath tumors and neurofibroma.

PURPOSE 4 : correlation between histopathology of the surgically resected neurofibroma/malignant nerve sheath tumors and MRI findings


Eligibility Criteria:
Inclusion Criteria:

* Patients with neurofibromatosis type 1, between 6 and 50 years old

Exclusion Criteria:

* Patients who are not allowed to be scanned on MRI (contra-indications: pacemaker ed.)
A Study of ELI-002 in Subjects With KRAS Mutated Pancreatic Ductal Adenocarcinoma (PDAC) and Other Solid Tumors

This is a Phase 1 study to assess the safety and efficacy of ELI-002 immunotherapy (a lipid-conjugated immune-stimulatory oligonucleotide \[Amph-CpG-7909\] plus a mixture of lipid-conjugated peptide-based antigens \[Amph-Peptides\]) as adjuvant treatment of minimal residual disease (MRD) in subjects with KRAS/neuroblastoma ras viral oncogene homolog (NRAS) mutated PDAC or other solid tumors.

This is a Phase 1 dose escalation study in which ELI-002 2P (Amph modified KRAS peptides, Amph-G12D and Amph-G12R admixed with admixed Amph-CpG-7909) will be evaluated, with plans to transition to the ELI-002 7P drug product containing all 7 Amph-Peptides (G12D, G12R, G12V, G12A, G12C, G12S, G13D) in future clinical trials.

The study is an open-label, dose-escalation, 3+3 design in which approximately 18 subjects will be treated in 3 planned dose level cohorts. Increasing doses of Amph-CpG-7909 will be evaluated sequentially. Additional cohorts may be added to explore intermediate or higher dose levels based on cumulative safety review and preliminary review of pharmacodynamic responses. Safety and pharmacodynamic data will be evaluated and a recommended Phase 2 dose (RP2D) will be determined in consideration of a maximum tolerated dose (MTD) if observed.

Eligibility Criteria:
Inclusion Criteria:

* KRAS/NRAS mutated (G12D or G12R) solid tumor
* Positive for circulating tumor DNA (ctDNA) and/or elevated serum tumor biomarker despite prior standard therapy including surgery and chemotherapy/radiation therapy where applicable
* Screening CT is negative for recurrent disease
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

* Presence of tumor mutations where specific therapy is approved, and the patient is able to receive the approved therapy
* Known brain metastases
* Use of immunosuppressive drugs
Diaphragmatic Echography After Thoracic Surgery

The investigator evaluated diaphragmatic function in patients undergoing thoracic surgery. Diaphragmatic displacement was evaluated before surgery, 2 and 24 hours after surgery. Also, preoperative spirometry and postoperative spirometry were collected (24 hours after surgery).


Eligibility Criteria:
Inclusion Criteria:

* Elective surgery for lung cancer
* Age \> 18
* ASA 2-3

Exclusion Criteria:

* BMI \> 35
* Contraindications for epidural catheter positioning
* History of neurodegenerative pathology
* Previous thoracic surgery
* Need for mechanical ventilation after surgery