cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Effect of Pirtobrutinib (LOXO-305) on QTc Interval in Healthy Participants

The main purpose of this study is to assess the effect of Pirtobrutinib (LOXO-305) on the heart rate-corrected QT (QTc) interval and to conduct blood tests to measure how much pirtobrutinib (LOXO-305) is in the bloodstream and how the body handles and eliminates pirtobrutinib. The study will also evaluate the safety and tolerability of pirtobrutinib. The study will last up to 71 days, including screening.


Eligibility Criteria:
Inclusion Criteria:

* Must have Body mass index (BMI) within the range of 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive at Screening
* Male and female participants in good health, determined by no clinically significant findings from medical history, 12-lead Electrocardiogram (ECG), vital sign measurements, or clinical laboratory evaluations as assessed by the investigator
* Female participants of non-childbearing potential and male participants who follow standard contraceptive methods
* Must have comply with all study procedures, including the 15-night stay at the Clinical Research Unit (CRU) and follow-up phone call

Exclusion Criteria:

* History or presence of any diseases or conditions of clinical significance by the Investigator (or designee) and/or Sponsor
* Positive serologic test for hepatitis B surface antigen (HBsAg), hepatitis B virus immunoglobulin M (HBV IgM) core antibody, hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antibody at Screening.
* Positive polymerase chain reaction (PCR) test for COVID-19 at Screening
* Known ongoing alcohol and/or drug abuse within 2 years prior to Screening
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee)
* Have previously received pirtobrutinib (LOXO-305) in any other study investigating pirtobrutinib (LOXO-305), within 30 days prior to Day 1
The Safety and Effectiveness of 524W91

To assess the safety and pharmacokinetics of single oral doses of 524W91 administered in HIV-infected patients. To determine the effects of food on bioavailability of 524W91.

Patients are randomized to receive six single escalating doses of 524W91 or placebo, with each dose separated by at least a 6-day washout interval. In the time between 2 of the doses, the effect of food on pharmacokinetics will be investigated, with one dose administered in conjunction with a high-fat meal and one dose administered in a fasted state.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* Documented HIV infection.
* CD4 count \>= 200 cells/mm3.
* No active opportunistic infection.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Malignancy or other condition that would confound study assessment or interfere with ability to complete the study.
* Malabsorption syndrome or other gastrointestinal dysfunction that might interfere with gastrointestinal absorption.

Concurrent Medication:

Excluded on the day of each dose:

* Antiretrovirals.
* Any prescription or over-the-counter medication.
* Alcoholic beverages.
* Coffee, tea, and other xanthine-containing beverages and foods.

Patients with the following prior conditions are excluded:

History of hepatitis, pancreatitis, or cardiomyopathy within the past 5 years.

Prior Medication:

Excluded:

* Antiretrovirals within 24 hours prior to each dose.
* Any prescription or over-the-counter medications within 48 hours prior to each dose.
* Alcoholic beverages within 48 hours prior to each dose. Current alcohol or illicit drug use that may affect patient compliance.
Blood Donation and Subjective Well-being

Studies have suggested a positive relationship between prosociality and well-being. attempt to analyze the relationship between blood donation and subjective well-being, and try to figure out the moderators and mediators. Also, the investigators would like to compare difference of subjective well-being between donors who are explicitly presented with information that the participants' blood has saved patient's life and those who are not.


Eligibility Criteria:
Inclusion Criteria:

* Whole blood donors with negative serological results.

Exclusion Criteria:

* Whole blood donors with positive or suspicious serological results.
Feasibility of the Camp Power Up Program on Children's Body Weight and Quality of Life

This study will evaluate the effects of a one week weight management summer camp on children's weight, quality of life, mood and feelings, self-esteem, weight management efficacy, enjoyment of physical activity, and body image.

Obesity affects 17% of children and adolescents in the U.S. Children are entrenched in an obesogenic environment, often with little support in the home, school, or medical environment to make healthy choices. Obesity is increasingly common in underserved communities that lack access and resources for physical activity and healthy eating. Louisiana is a prime example of the need for effective obesity treatment, ranking 1st nationally for adult obesity and 4th for adolescent obesity with the highest obesity prevalence among African American adolescents. We urgently need evidence-based programs to help children and families change lifestyle behaviors, achieve clinically significant weight loss, and thereby reduce the prevalence of pediatric obesity.

The U.S. Preventive Services Task Force identifies behavioral treatment including dietary, physical activity, and behavioral counseling components as a viable option for pediatric obesity treatment, yet a key challenge is how to implement these programs to maximize access and participation. Summer (between school years) represents an opportunity for intensive intervention to change health behaviors and help children to lose weight. During the summer months, children gain weight at a more rapid pace and spend more time engaged in sedentary behavior compared to the school year.

The American Diabetes Association launched Camp Power Up as a summer week-long day camp for youth who are obese and/or at high risk for developing type 2 diabetes. The camp will focus on wellness education, nutrition, physical activity, and obesity prevention. The purpose of the proposed study is to examine effects of Camp Power Up on children's weight status and their psycho-social health.

Eligibility Criteria:
Inclusion Criteria:

* Aged 6 to 14 years
* Enrolled in the American Diabetes Association (ADA) Camp Power Up

Exclusion Criteria:

-
A Study to Evaluate Efficacy, Safety, and Tolerability of Darigabat in Participants With Panic Disorder

The purpose of this trial is to measure the efficacy, safety, and tolerability of darigabat (25 milligrams \[mg\] twice daily \[BID\]) compared with placebo in participants with panic disorder.


Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis of panic disorder based on Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR), as confirmed by the Standard Mini International Neuropsychiatric Interview (MINI)
* Participant has had a minimum of 8 panic attacks, with no week free of panic attacks, in the month prior to the Screening Visit. In the 2 weeks prior to the Baseline Visit, the participant must have had at least 4 panic attacks and no week free of panic attacks
* Participants with a PDSS total score ≥12 at the Screening and Baseline Visits
* Body mass index of 17.5 to 40.0 kilograms per meter square (kg/m2) and a total body weight \>48 kg at Screening

Exclusion Criteria:

* Participants who have a current significant psychiatric comorbidity
* Any newly initiated evidence-based psychotherapy, including cognitive behavioral therapy (CBT)
* Any exposure-based therapy is prohibited throughout the duration of the trial
* Participants with a current history of significant cardiovascular, pulmonary, gastrointestinal, renal, hepatic, metabolic, hematological, immunological, or neurological disease
* Participants who answer "Yes" on the following C-SSRS Suicidal Ideation Items (within the last 6 months)

  * Suicidal Ideation Item 4 (Active Suicidal Ideation with Some Intent to Act, Without Specific Plan) OR
  * Suicidal Ideation Item 5 (Active Suicidal Ideation with Specific Plan and Intent) OR Participants who answer "Yes" on any of the 5 C-SSRS Suicidal Behavior Items (within the last 2 years)
  * Any of the Suicidal Behavior items (actual attempt, interrupted attempt, aborted attempt, preparatory acts, or behavior) OR
  * Participants who, in the opinion of the investigator, present a serious risk of suicide

NOTE: Other protocol-defined inclusion/exclusion criteria may apply
A Study to Assess Safety of ImbruvicaTM in Indian Participants With Chronic Lymphocytic Leukemia or Mantle Cell Lymphoma Who Have Received at Least One Prior Therapy or Chronic Lymphocytic Leukemia With 17p Deletion

The primary purpose of this study is to evaluate the post-marketing safety of ImbruvicaTM (ibrutinib capsule 140 milligram \[mg\]) under actual conditions of use, and to understand the incidence of adverse events (AEs) (serious and non-serious AEs).


Eligibility Criteria:
Inclusion Criteria:

* Chronic lymphocytic leukemia (CLL) or mantle cell lymphoma (MCL) participants being newly initiated on Imbruvica treatment (ibrutinib capsule 140 milligram \[mg\]) based on independent clinical judgment of treating physicians as per locally approved prescribing information
* Must give a written informed consent indicating that they understand the purpose and are willing to participate in the study and allowing data collection and source data verification in accordance with regulatory requirements

Exclusion Criteria:

* Participants who are not eligible to receive Imbruvica as per the locally approved prescribing information
* Participants participating or planning to participate in any interventional drug trial during the course of this study
Analgesic Effect of Intra-articular Dexamethasone and Dexamethasone Added to Bupivacaine in Interscalene Brachial Plexus

the aim of this study was to investigate the analgesic efficacy of intra articular dexamethasone administration for arthroscopic shoulder surgery.

shoulder surgery can be very painful and interscalene brachial plexus block is the gold standard in the management of acute pain after shoulder surgery. various local anaesthetic mixtures can be used to prolong local anaesthesia duration and epinephrine , opioids and dexamethasone are frequently used for this purpose. dexamethasone has also been found the prolong the duration of lidocaine axillary blocks and intravenous regional anaesthesia. intraarticular administration of medicines can be used for management of joint pain and opioids , local anaesthetics and dexamethasone are used for this purpose.In addition, there are no studies available to compare the different treatment methods used in clinical practice directly.

Eligibility Criteria:
Inclusion Criteria:

* between 18-65 years
* arthroscopic shoulder surgery
* no known allergies to drugs
* ASA 1-2 patients

Exclusion Criteria:

* history of diabetes
* history of chronic pain treatment
* pregnancy
* severe bronchopulmonary disease
* systemic glucocorticoid use
Korean Post Marketing Surveillance for ELREXFIO (Elranatamab).

This study is to assess the safety and effectiveness of Elranatamab in the real-world clinical settings for the treatment of patients with multiple myeloma in Korea.

This study is an open-label, multi-center, non-comparative, observational study to assess safety and effectiveness of Elranatamab in the real-world clinical setting in patients with multiple myeloma in Korea.

During the study period within 2 years from the launch date, a whole case enrollment should be conduct according to the protocol.

The objectives of this study are to determine safety and effectiveness with Elranatamab under conditions of general clinical practice, in compliance with the regulation of the MFDS. Therefore, this study was designed according to the PMS guidelines of the MFDS.

The study population is patients who are eligible for "Indications" specified in the approved label.

All assessments described in this protocol are performed as part of normal clinical practice or standard practice guidelines for the patient population and healthcare provider specialty in the countries where this Non-interventional study (NIS) is being conducted.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have been prescribed ELREXFIO (Elranatamab) by their physician as monotherapy for the treatment of adult patients with relapsed or refractory multiple myeloma, who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.
* Patients with evidence of a personally signed and dated informed consent/assent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Exclusion Criteria:

* Patients with contraindication according to locally approved label of ELREXFIO (Elranatamab)
* Any patients (or a legally acceptable representative) who does not agree that Pfizer and companies working with Pfizer use his/her information
Newborn Phosphocalcic Metabolism After Intravenous Iron Administration During Pregnancy

Iron deficiency anemia (IDA) is a very common health problem during pregnancy and intravenous (IV) iron substitution has become part of routine management. Recent studies have raised concerns about association of IV iron infusion and development of secondary transitory hypophosphatemia (HP) in adults including pregnant women. The study aimed to evaluate the impact of IV iron administration during pregnancy on newborn's phosphatemia.

The investigators conducted a prospective, single-center, observational study in the Geneva University Hospitals (HUG), from September 2022 to March 2023. Pregnant women treated either with IV iron or with oral iron during pregnancy were included. At delivery, a maternal blood sample to assess hemoglobin, hematocrit, ferritin, phosphate and calcium and an umbilical cord blood sample to assess levels of phosphate and calcium were collected. Difference in demographics and clinical characteristics between the two groups were explored using univariate analyses. Multivariate analyses were performed to test the contribution of IV iron substitution on cord blood phosphatemia and calcemia, considering potential confounding factors. Neonatal HP was defined as a phosphate level lower than 1.3 mmol/L.


Eligibility Criteria:
Inclusion Criteria:

* Single pregnancy
* Term (\>37SA) pregnancy
* Oral or IV iron substitution from second trimester

Exclusion Criteria:

* Multiple pregnancy
* Fetal anomalies
* Preterm birth
Neurodevelopmental Outcomes and Fluconazole Prophylaxis

The purpose of this study is to compare the neurodevelopmental outcome and quality of life between the fluconazole-treated and the placebo-treated patients that were enrolled in a fluconazole prophylaxis study that occurred in the investigators' neonatal intensive care unit (NICU) between 1998-2000.

Invasive fungal infections in preterm infants is associated with significant morbidity and mortality. Mortality in infected infants \< 1000 grams is between 26-66% and neurodevelopmental impairment occurs in 57%.1-13 Between 1998-2000 we conducted a randomized placebo controlled trial of fluconazole prophylaxis in 100 infants \<1000 grams at birth(IRB-HSR #9389). Invasive fungal infections occurred in none of the fluconazole-treated patients compared to 20% of the placebo group. Following this study the efficacy has been confirmed in a multicenter randomized controlled trial and 7 retrospective studies. One major issue that has remained is whether the fluconazole-treated infants have better neurodevelopmental outcomes as well as if it is safe without an increase in neurodevelopmental impairment.

Neurodevelopmental outcomes can be assessed by testing and examinations or by parental and child questionnaires. In addition, quality of life is an important context of outcomes. Recent conceptualizations of quality of life recognize the multidimensional nature of quality of life, including psychological and social functioning, consistent with the World Health Organization's definition of health as "not only the absence of disease and infirmity, but the presence of physical, mental, and social well-being." The World Health Organization subsequently emphasized the growing consensus that quality of life is a subjective experience, defined as "individuals' perceptions of their position in life in the context of the culture and value systems in which they live, and in relation to their goals, expectations, standards, and concerns."

To address these issues, we aim to study and compare the neurodevelopmental outcome and quality of life between our fluconazole-treated and placebo-treated patients in our initial study

Eligibility Criteria:
Inclusion Criteria:

* Parents or guardians and their infants who survived and were enrolled in our initial study of fluconazole prophylaxis for prevention of fungal colonization and infection in preterm infants \< 1000 grams

Exclusion Criteria:

* Persons not meeting the inclusion criteria
Dexmedetomidine and Dexamethasone as an Adjuvant to Ropivacaine in Thoracic Surgery

The aim of the study is to investigate the effect of preoperative epidural dexmedetomidine compared to dexamethasone on postoperative pain control, analgesic consumption and oxydative stress response in patients undergoing thoracic surgery

The aim of the study is to investigate the effect of preoperative epidural dexmedetomidine compared to dexamethasone on postoperative pain control, analgesic consumption and oxydative stress response in patients undergoing thoracic surgery.

Investigation will include patients between 30-70 years undergoing thoracic surgery due to malignant process of lung or oesophagus.

Patients are divided in two groups: epidural administration of 0.375% ropivacaine with 1 mcg/kg dexmedetomidine (group 1) and epidural administration of 0.375% ropivacaine with 8 mg dexamethasone.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing thoracic surgery due to malignant process of lung or oesophagus ASA (American Society of Anesthesiologists) status I-III

Exclusion Criteria:

* neurological or psychiatric disease
* corticosteroid therapy
* anamnesis of myocardial infarct within last 6 months
* severe aortic stenosis
* kidney insufficiency
* liver insufficiency
* allergy
* coagulation disorders
Epidemiology Study on Neonatal Seizure

A Multicentre, observational and cohort study to get the incidence of new-onset or newly-diagnosed seizure in neonatal population. EEG will used to record the change of brain electric activity and diagnose. Other data also will be collected since first seizure until confirmed diagnosis.

This study is designed to describe the incidence of newborn with uncontrolled seizures. Seizures can be associated with any high-risk factors during perinatal stage and diagnosed by abnormal electrical activity in the brain.

In this study researchers will use electroencephalography (EEG) to determine and monitor newborn with uncontrolled or suspected seizures. EEG works by measuring electrical activity in different areas of the brain. The EEG allows researchers to examine changes in the EEG along with the clinical features of seizures as they occur.

In addition to monitoring electrical activity of the brain, researchers will collect demographic, medical history, family, perinatal stage, birth, growth, feeding condition by medical records and questionnaire. These information will allow researchers to learn more about what high-risk factors influence the incidence of neonatal seizure in China.

Eligibility Criteria:
Inclusion Criteria:

* Age from 0\~28 days;
* Clinical diagnosed with seizure;
* EEG diagnosed with seizure;
* Parents who consent to their participation in the study;

Exclusion Criteria:

* Parents who will not comply to the needs and the design process.
Manual Therapy and Exercise in Low Back Pain

Non-specific low back pain is one of the main causes of disability for health care worldwide. The effectiveness of therapeutic exercise, of kinesio tape and of manual therapy in the treatment of low back pain is evaluated, but not a comparison of these techniques. Moreover, can these techniques be combined?

Non-specific low back pain is one of the main causes of disability for health care worldwide. Nowadays, the mostly used technique to research low back muscular activity is electromyography.

Among the published studies, the effectiveness of therapeutic exercise, of kinesio tape and of manual therapy in the treatment of low back pain is evaluated, but not a comparison of these techniques.

The main objective that is aimed by this thesis, is the evaluation of muscular activation in the reduction of non-specific low back pain through a 12 weeks procedure programme, which includes therapeutic exercise combined with other treatment techniques, and assessing the psycho-social characteristics of pain.

This study's population will be composed by at least 16 individuals per group, both male and female, with ages among 20 and 80.

Participants will be randomly and blindly divided in three groups of intervention. The three groups will be: the experimental group or EXP Group (all participants subject to therapeutic exercise), the experimental group, which will also be subject to manual therapy (MT Group) and finally, the experimental group, which will also be subject to kinesio tape work (KT Group).

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with low back pain.
* Patients who are in Stage 1 of the Oswestry scale.
* Not receiving pharmacological treatment such as anti-inflammatories or corticosteroids
* Be able to understand the exercises and spanish language.

Exclusion Criteria:

* Having any back surgery.
* Be taking any medication at the time of the study.
* Have a pathology in which exercise is contraindicated (spondylolisthesis, spondylolysis, spondyloarthrosis).
* Be in a state of gestation or if there is the possibility of being.
* Present or have presented some oncological process.