cyrilzakka/clinical-trials huggingface dataset:
JSP191 (briquilimab) in Subjects with LR-MDS

A Phase 1 study in subjects with LR-MDS to assess the safety and tolerability of JSP191 as a second-line therapy.

An open-label, single-arm, dose-escalation study designed to determine the potential safety, efficacy, maximum tolerated dose (MTD) or optimal biologic dose (OBD), and recommended phase 2 dose (RP2D) of JSP191 (briquilimab) monotherapy for LR-MDS subjects with documented cytopenia (red blood cell-transfusion dependent, thrombocytopenia, and/or neutropenia).

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* MDS with IPSS-R very low, low, or intermediate risk features
* Symptomatic cytopenias
* Women of childbearing potential (WOCBP) must agree to use an oral or implanted contraceptive, a double-barrier method of birth control, or an intrauterine device upon enrollment and through 3 months after receiving the last dose of JSP191
* Women not of childbearing potential must be post-menopausal (no menstrual period for a minimum of 12 months) or surgically sterilized and have a negative serum pregnancy test upon study entry
* Male subjects must be surgically sterile or willing to use contraception upon enrollment and through 3 months after receiving the last dose of JSP191
* Must be willing and able to provide informed consent

Exclusion Criteria:

* Anemia secondary to iron deficiency, vitamin B12 deficiency, or folate deficiency
* Prior allogeneic or autologous stem cell transplant
* Known history of human immunodeficiency virus (HIV) (no laboratory testing is required), or active infection with hepatitis B or hepatitis C
* Pregnant women or women who are nursing and do not wish to discontinue breastfeeding
* Any other medical condition that, in the opinion of the Investigator, could pose a significant safety risk to the subject or jeopardize the integrity of the study
* Subjects who, in the opinion of the Investigator, may not be able to comply with the requirements of the study
Topical Tofacitinib for the Treatment of Alopecia Areata and Its Variants

The purpose of the study is to investigate the use of topical tofacitinib to promote hair regrowth in patients with alopecia areata, alopecia totalis, and alopecia universalis.

This will be an open label clinical trial. We plan to treat 10 adults with AA (with at least 2 patches of alopecia involving the scalp), AT or AU with tofacitinib ointment for a maximum of 6 months. During treatment, patients will be evaluated every 4 weeks and effectiveness of the medication will be measured by changes in hair growth. Laboratory evaluation will be performed before and during treatment in order to monitor for adverse effects of the medication.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of AA with at least 2 patches of alopecia involving the scalp, AT or AU
* Stable hair loss present for 6 months or longer
* No treatment for alopecia areata in the past 1 month
* No evidence of spontaneous hair regrowth

Exclusion Criteria:

* Patients have received treatment known to affect alopecia areata within 1 month of enrolling in the study
* Patients whose current episode of AT or AU is more than 5 years
* Patients with a history of malignancy (except history of successfully treated basal cell or squamous cell carcinoma of the skin)
* Patients known to be HIV or hepatitis B or C positive
* Patients with positive tuberculin skin test or positive QuantiFERON® TB test
* Patients with leukopenia or anemia
* Patients with renal or hepatic impairment
* Patients taking immunosuppressive medications, including but not limited to prednisone, methotrexate, mycophenolate mofetil, azathioprine, tacrolimus, cyclosporine, or TNF-α inhibitors
* Women who are pregnant or nursing
Magnesium Sulphate in Oblique Subcostal TAP Block

The aim of this study is to evaluate the effect of adding different doses of MgSO4 to bupivacaine via OSCTAB block on postoperative pain control for 24 hours in patients scheduled for LC.

Laparoscopic cholecystectomy (LC) is a gold standard for management of gallbladder stones. Early and easily recovery, less operative morbidities, less postoperative pain, improved cosmetics, less hospitalization days and decreased cost are the superiorities of laparoscopic cholecystectomies over open surgical procedures.

Postoperative pain is the major obstacle for early postoperative ambulation and prolongs the hospital stay. Moreover, it has been hypothesized that intense acute pain after LC may predict development of chronic pain (e.g., post laparoscopic cholecystectomy syndrome). So, aggressive perioperative pain prevention is mandatory.

This pain is routinely managed using opiates, which has several side effects. Transversus abdominis plane (TAP) block is a regional anesthetic technique that has gradually become an alternative for postoperative pain control during laparoscopic abdominal surgeries. It involves the infusion of local anesthetic into the fascial plane of the abdominal wall. Oblique subcostal transversus abdominis plane (OSCTAP) block is an US-guided regional anesthesia technique that anesthetizes the nerves of the lower and upper anterior abdominal wall, specifically from T6 to L1.

Rafi et al and McDonnell et al were the first to describe (OSCTAP) block. They described an anatomical landmark technique and provided evidence of blockade to the mid/lower thoracic and upper lumbar spinal nerves as they travelled in the fascial plane between the transversus abdominis (TA) and internal oblique (IO) muscles.

Evidence supporting the presence of (NMDA) receptors in skin and muscles have led to the use of (MgSO4) which is NMDA antagonist via different routes.

Eligibility Criteria:
Inclusion Criteria:

* • Patients programmed for elective LC.

  * American society of anesthesiologists (ASA) physical state I or II.
  * Age over 18 years and less than 60 years old.
  * Patients of both sex are included in the study.

Exclusion Criteria:

* • Patient refusal.

  * Known hypersensitivity to the study drugs.
  * Body Mass Index \> 40 kg/m2.
  * Inability to accurately describe postoperative pain to investigators.
  * Opioid tolerance or dependence.
  * Preexisting history of chronic pain.
  * History of renal, liver, cardiac, neuropsychiatric disorder problems.
  * Bleeding or coagulation abnormality.
Study on the Pharmacokinetics (PK) of DFN-15 vs Comparator and Food-effect on DFN-15 PK in Healthy Adult Subjects

An Open-Label, Three-Way Randomized, Single Dose Crossover Study Comparing Bioavailability of DFN-15 under fasting conditions versus Comparator under fed conditions and to determine food-effect of DFN-15 in Healthy Adult Subjects


Eligibility Criteria:
Inclusion Criteria:

* Healthy, adult, male or female 19-55 years of age, inclusive, at screening.
* Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs, as deemed by the PI or designee.
* Females of childbearing potential: must either be sexually inactive (abstinent) for 30 days prior to the first dose and throughout the study or be using birth control method; Female subjects of non-childbearing potential and must have undergone sterilization procedures or be postmenopausal for at least 1 year prior
* Male subject must agree to use contraception or abstain during the study until 90 days beyond the last dose of study drug.
* Understands the study procedures in the informed consent form (ICF), and willing and able to comply with the protocol.

Exclusion Criteria:

* History or presence of hypersensitivity or idiosyncratic reaction to celecoxib, sulfonamides, aspirin or other NSAIDs or related compounds
* History or presence of clinically significant medical or psychiatric condition or disease
* History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study
* liver enzyme tests greater than the upper limit of normal at screening
* Estimated creatinine clearance \<90 mL/minute at screening
* History or presence of alcoholism
* History or presence of bilateral pedal edema or generalized edema or fluid retention
* Female subjects who are pregnant or lactating or actively trying to conceive
* Positive urine drug or alcohol results at screening or check-in
* Positive cotinine at screening
* Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV)
* Seated blood pressure is less than 90/60 mmHg or greater than 140/90 mmHg at screening
* Seated heart rate is lower than 45 bpm or higher than 100 bpm at screening
* Has been on a diet incompatible with the on-study diet
* Unable to refrain from or anticipates the use of prohibited medications
* Donation of blood or significant blood loss within 56 days prior to the first dose of study drug; plasma donation within 7 days prior to the first dose of study drug
* Participation in another clinical trial within 28 days prior to the first dose of study drug
Conditioning Regimens for Patients With Severe Aplastic Anemia Transplanted With Marrow From an Unrelated Donor

A single arm dose optimization study in which all patients are given a fixed dose of Cytoxan (4 x 50 mg/kg) plus ATG (3 x 30 mg/kg) and the TBI dose starting at 3 x 200 cGy is escalated or de-escalated dependent upon engraftment and toxicity.


Eligibility Criteria:
Inclusion Criteria:

* Life-threatening marrow failure of nonmalignant etiology;
* failure to respond to the best available immunosuppressive treatment;
* lack of a HLA-identical family member

Exclusion Criteria:

* Severe disease other than aplastic anemia that would severly limit the probability of survival during the graft procedure;
* HIV seropositive patients;
* clonal abnormalities or myelodysplastic syndrome;
Prevalence and Factors Associated With Sleep Disorders in Inflammatory Bowel Disease

Inflammatory bowel diseases (IBD) including Crohn's disease (CD) and ulcerative colitis (UC), are an inflammatory disease that can affect the entire digestive tract from the mouth to the anus for CD and the entire colon and rectum for UC. They mainly affect adolescents and young adults. These pathologies evolve in relapses interspersed with phases of remission. Sometimes associated with extraintestinal manifestations (joint, dermatological, ophthalmological or biliary systems), chronic inflammation of the digestive tract and the resulting symptoms (abdominal pain, diarrhea, rectal syndrome, etc.) lead to a significant alteration in the quality of life of patients in all spheres of activity (professional, sexual, social).

Sleep is a basic neurophysiological state, the normal total duration of which in humans is between six and ten hours per day. It is an essential element of the circadian rhythm in humans, influencing certain cellular functions and in particular the synthesis of cytokines and pro-inflammatory molecules. Sleep disturbances and disruption of the circadian rhythm lead to metabolic and immunological dysfunctions, which may be involved in chronic inflammatory conditions through changes in the immune response.

In the field of IBD, many studies suggest poor sleep quality in patients with IBD. While there seems to be a link between sleep disorders and impaired quality of life with a socio-professional impact in these patients, the links between IBD activity, its treatment and sleep disorders are poorly studied, with discordant results in previous studies.

In order to enrich our knowledge on this topic, the investigators wish to study the prevalence and risk factors associated with sleep disorders in IBD patients in order to improve patients' quality of life


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with Crohn's disease (CD) or ulcerative colitis (UC) presenting for consultation or hospitalization in Gastroenterology unit

Exclusion Criteria:

* Patients with an identified sleep pathology
Field Paramedic Application of Sepsis Triage

Given the implementation of the Hamilton Early Warning Score (HEWS) and the use of capnography by paramedics, this study will involve a large multi-site retrospective evaluation (before vs after implementation) of the HEWS score and comparison of the HEWS to systemic inflammatory response syndrome (SIRS), quick Sepsis Related Organ failure Assessment (qSOFA) and Modified Early Warning Score (MEWS) when applied retrospectively for the identification of sepsis in the prehospital setting.

1. To determine the accuracy of the HEWS score, compared to qSOFA, and SIRS for early sepsis recognition when used in the prehospital setting by paramedics for the identification of patients with sepsis or suspected sepsis.
2. To evaluate the addition of ETCO2 values to predict mortality in patients who screen positive for sepsis.
3. To identify the before and after healthcare outcomes of a prehospital sepsis alert program.

Eligibility Criteria:
Inclusion Criteria:

Any patient to which paramedics apply the Hamilton Early Warning Score or patients who arrive to the Emergency Department (ED) by ambulance without a pre-alert and meet the definition of sepsis in the ED will also be included, and patient is ≥ 18 years

Exclusion Criteria:

Patient is an inter-facility transfer, or patients with absent vital signs are absent, or death before blood can be drawn in the Emergency Department, or the patient fits the criteria for another prehospital alert (ST-elevation myocardial infarction, cerebrovascular vascular accident, or trauma)
Continuous Versus Interval Walking Training in Patients With COPD - a Pilot Study

This study will investigate the effects of interval walking training versus continuous walking training in patients with chronic obstructive pulmonary disease. Patients will be recruited during a 3-week inpatient pulmonary rehabilitation program and will be randomized to one of the two intervention groups. All walking training sessions will be performed on the same treadmill. Walking intensity in the continuous walking group will be 60 percent of the average speed of the 6-minute walking test. Patients in the interval training group will perform high intensity intervals at 120% of the 6-minute walking test speed for 60 seconds alternating with 60 seconds of rest. The total exercise duration will be progressively increased from 10 to 32 minutes.


Eligibility Criteria:
Inclusion Criteria:

* COPD stage III or IV according to the Global Initiative for chronic obstructive lung disease \[GOLD\]
* stationary patient in the Schön Klinik Berchtesgadener Land

Exclusion Criteria:

* acute, severe exacerbation of COPD
* failure to comply with study process
A Drug Interaction Study of Albiglutide and Digoxin

This Phase I, open-label, sequential, single-center study evaluates the pharmacokinetics of digoxin when coadministered with albiglutide in healthy adult subjects.

This Phase I, open-label, sequential, single-center study evaluates the pharmacokinetics of digoxin when coadministered with albiglutide in healthy adult subjects. Subjects will receive a single dose of digoxin on Day 1 followed by 5 weekly subcutaneously injected doses of albiglutide and a second single dose of digoxin on Day 38. To determine the plasma pharmacokinetic parameters of digoxin after drug administration alone and after multiple doses of albiglutide, blood samples will be collected after each dose of digoxin.

Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers
* female subjects must be of nonchildbearing potential
* no clinically significant diseases or clinically significant abnormal laboratory values
* body mass index (BMI) is \>/=18 kg and ≤30 kg/m2
* a nonsmoker

Exclusion Criteria:

* positive test results for hepatitis B, hepatitis C or human immunodeficiency virus
* female subject is pregnant or breast-feeding
* history of any anaphylactic reaction to any drug
* history of significant cardiovascular or pulmonary dysfunction
* current or chronic history of liver disease
* history of alcohol or substance abuse
* history of thyroid disease or dysfunction
* history of gastrointestinal surgery or disease
* history of pancreatitis
* history of cholecystitis or other gallbladder disease
* previously received any GLP-1 mimetic compound (e.g., exenatide)
Effects of Structured Skills Training Group in Treatment of ADHD in Adults

This study aims to examine if structured skills training group therapy for ADHD in adults has beneficial effects superior to 'treatment as usual' including medication in a controlled outpatient setting on clinically relevant outcomes including symptoms, functioning and quality of life measures.

The trial is designed as a multicenter randomized controlled, parallel group study. Patients are randomized into 1 of 2 treatment arms with 14-week duration: one arm with initial intervention by structured skills training groups by weekly sessions or one with control condition (treatment as usual). Then after 15 weeks patients in the control condition arm are switched to the active intervention by 14 weeks of structured group therapy. All patients are assessed for defined outcomes after six months.

Background: The focus in recent years on evidence for non-pharmacological treatment in adults with ADHD raises the question of potential effects of structured group therapy. Structured skills training groups have shown beneficial effects in some studies in an outpatient psychiatric context by reduction in ADHD symptoms in individuals who remained stable regarding medication status.

Aims: The main objective for the trial is to investigate the potential effects of structured skills training groups in a clinically relevant but still controlled setting on broader outcomes including both symptomatic, functional and health related quality of life measures.

Methods/Design: The trial is designed as a multicenter randomized controlled parallel group design. At each outpatient site the enrolled patients are randomized into two groups for either Group 1 (G1) with start of weekly treatment in active structured skills training group lasting for 14 weeks or allocated to Group 2 (G2) with treatment as usual/clinical management and with 15 weeks delayed start of their group treatment for comparison wth patients in the other arm. Those patients in the control condition arm receiving treatment as usual or clinical management of individual patients (G2), are thereafter switched to active structured skills training group therapy.All patients are followed up after six months with assessments of primary and secondary outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ADHD according to the Diagnostic and Statistical Manual of Mental Disorders, 4th. Edition (DSM-IV) persisting in adulthood

Exclusion Criteria:

* Any psychotic disorder
* Recently suicidal behaviour
* Substance or alcohol abuse or dependence within three months prior to screening for inclusion
* Pervasive developmental disorder
* Intellectual disability
* Seizures or any neurological diseases causing mental handicap
TRanscriptomic Analysis of Circulating Endothelial Cells During Sepsis - TRACES Study

Vascular dysfunction is an important mechanism involved in organ failure, in the setting of sepsis condition, with different types of circulating endothelial cells.Transcriptom analysis via RNAseq in different types of circulating endothelial cells, comapring critically ill patients with or without sepsis will allow determining differential gene expression for signal pathways in endothelial alteration and restoration associated with sepsis.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 85 years
* Admission in intensive care with or without sepsis
* Health insurance as per the national insurance system
* Informed and unopposed patient for participation (or referend closed one)

Exclusion Criteria:

* Patient under legal protection
* Patient under national medical help system
* Pregnancy
Study of Intravenous GMI-1070 in Adults With Sickle Cell Disease

This Phase 1/Phase 2 study will evaluate GMI-1070, a pan-selectin inhibitor, in adults with stable sickle cell disease. The study will assess safety, pharmacokinetics, and microvascular effects of intravenous GMI-1070 in the outpatient setting.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 45 years
* Established diagnosis of SCD-SS or SCD-SB0-thal
* At medical baseline, with no evidence of worsening of disease over the last 3 months
* Available and agree to return for follow-up visits for the full duration of the study
* Able to cooperate with study procedures
* Documented and observed written informed consent

Exclusion Criteria:

* Vaso-occlusive crisis
* Recent major surgery, hospitalization, infection, significant bleeding, cerebrovascular accident or seizure, or transfusion
* Currently receiving, or has received within the previous 4 weeks, any other investigational agent
* Pregnant or lactating female; or female of childbearing age unable or unwilling to comply with birth control or abstinence during the course of the study
Effectiveness of the Mediterranean Diet on Weight Loss After Endoscopic Bariatric Treatmen

All participants were weighed every week for 24 weeks, wearing light clothes to the nearest 0.1 kg, using a body composition analyzer. Height was determined during the first clinic evaluation using a fixed wall stadiometer to the nearest 0.1 cm, in standing position.

Intervention: Participants followed a liquid diet plan during the first week after the endoscopic bariatric procedure (Bioenterics Intragastric Balloon - BIB - or Primary Obesity Surgery Endoluminal - POSE -). Subsequently, subjects were randomly assigned either a Mediterranean-style or a protein diet plan. Energy intake was calculated according to the Spanish Consensus on Bariatric Endoscopy.

The hypothesis of this project is to analyze whether the Mediterranean-style diet is more effective compared with the open protein diet plans in weight loss and weight relapse in subjects with obesity who underwent endoscopic bariatric therapies.


Eligibility Criteria:
Inclusion Criteria:

* no previous gastric intervention
* no hiatus hernias
* not being pregnant or in breastfeeding
* not having cardiac problems, and having regular values in coagulation and blood count,
* having a positive psychological evaluation.

Exclusion Criteria:

* lack of compliance with the dietary treatment
* adverse effects of the surgery
* refuse to complete the treatment
* lack of adherence