cyrilzakka/clinical-trials huggingface dataset:
Single and Multiple Dose Evaluation of QBKPN SSI In Healthy Volunteers

The purpose of this dose-escalation study is to assess the safety and pharmacodynamics of single and multiple doses of QBKPN SSI, administered subcutaneously to healthy adult volunteers


Eligibility Criteria:
Inclusion Criteria:

* Healthy, non-smoking (at least for 6 months prior to first study drug administration) males or females, 18 to 65 years of age, inclusive at the time of informed consent.
* Body mass index (BMI) that is within 18.5 - 30.0 kg/m2, inclusive.
* Healthy, according to the medical history, ECG, vital signs, laboratory results and physical examination
* Systolic blood pressure between 95-140 mmHg, inclusive, and diastolic blood pressure between 55-90 mmHg, inclusive, and heart rate between 50-100 bpm, inclusive, unless deemed otherwise by the PI/Sub-Investigator.
* QTc interval ≤ 450 milliseconds for males and females, unless deemed otherwise Not Clinically Significant by the Principal Investigator/Sub-Investigator.
* Availability to volunteer for the entire study duration and willing to adhere to all protocol requirements.
* Agree not to have a tattoo or body piercing until the end of the study.
* Agree to practice effective methods of contraception

Exclusion Criteria:

* Known history or presence of any clinically significant hepatic, renal/genitourinary, gastrointestinal, cardiovascular, cerebrovascular, pulmonary, endocrine, immunological, musculoskeletal, neurological, psychiatric, dermatological or hematological disease or condition unless determined as not clinically significant by the PI/Sub-Investigator.
* A known history or positive test result for human immunodeficiency virus (HIV), chronic Hepatitis B surface antigen, or Hepatitis C.
* A positive test result for drugs of abuse (marijuana, amphetamines, barbiturates, cocaine, opiates, phencyclidine and benzodiazepines), alcohol test and cotinine. Positive pregnancy test for female subjects.
* Known history or presence of (1) Alcohol abuse or dependence within one year prior to first study drug administration; (2) Drug abuse or dependence; (3) Known or suspected hypersensitivity to any component of the product (4) Food allergies and/or presence of any dietary restrictions; or (5) Severe allergic reactions (e.g. anaphylactic reactions, angioedema).
* Recent history (within 8 weeks prior to screening) of travel to or emigration from any country with high incidence for tuberculosis.
* A positive tuberculin skin (PPD) test result
Protein Ingestion and Resistance Exercise in Elderly

The mail goal of this randomized controlled, dietary intervention study is to investigate whether protein supplementation in combination with resistance exercise can increase muscle mass and strength in elderly. Loss of muscle mass and -strength is frequent in this group. Participants (N = 220, equal distribution between men and women) are randomized to one of three groups receiving different quantities and qualities of protein supplementation after exercise. The results of this study will be used to form recommendations regarding diet and exercise for the prevention of this frequent health problem in elderly.


Eligibility Criteria:
Inclusion Criteria:

* 65 years and older

Exclusion Criteria:

* uncontrolled coronary heart disease
* pharmacological interventions with drugs known to affect muscle mass
* major orthopedic disease
* low cognitive function.
Using Ex Vivo Tumoroids To Predict Immunotherapy Response In NSCLC

To test whether it is feasible to perform the 3D-EX functional predictive response bioassay in the context of patients with advanced/metastatic NSCLC receiving immune checkpoint inhibitors in the standard of care clinical setting.

Non-small cell lung cancer (NSCLC), which accounts for approximately 85% of all lung cancer cases, remains the leading cause of cancer death worldwide. Immunotherapy such as using immune checkpoint inhibitors (ICIs) to target the programmed death-1 and its ligand (PD-1/L1) has revolutionized our management of this deadly disease.

However, a large proportion of patients do not derive benefit due to primary, adaptive or acquired resistance. Hence, better identifying this patient population, understanding the resistance mechanism and exploring novel combinations with current SOC immunotherapy are urgently needed to continue to benefit our NSCLC patients.

The investigators hypothesize that patient-derived immune cell containing ex-vivo tumoroids could serve these purposes. In this study, the investigators plan to develop such a 3D ex-vivo system utilizing fresh biopsied tissue from NSCLC patients. The investigators plan to prospectively evaluate the value of these ex-vivo tumoroids in immunotherapy naive advanced/metastatic NSCLC patients who will be receiving anti-PD-1/L1 (with or without anti-CTLA-4) per standard-of-care.

Eligibility Criteria:
Inclusion Criteria:

* Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent
* Patients with advanced/metastatic NSCLC
* Must be immunotherapy naive
* Males and females age ≥ 18 years
* ECOG Performance Status 0 - 2
* Measurable disease by RECIST 1.1
* Must have a lesion (either primary or metastatic lesion) that can be safely biopsied to have sufficient tissue (at minimum, 3-4 cores using 20g or larger core biopsy) to generate tumoroids
* Must have at least one target lesion to evaluate treatment response
* Will be receiving anti-PD-1/L1 with or without anti-CTLA-4 per standard of care Adequate organ function defined per standard of care in this setting.
* Women of child-bearing potential and men with partners of child-bearing potential must agree to practice sexual abstinence or to use the forms of contraception as required/recommended by each immune checkpoint inhibitor used in the setting of standard of care.

Exclusion Criteria:

* Incarcerated
* Not competent to make medical decision, noncommunicative or noncompliant per investigator's judgement.
Investigation of the Effect of Proximal and Distal Adductor Canal Block in Knee Replacement Surgery

to investigate the effect of adductor canal block applied with two different approaches in the treatment of pain after TKA surgery on pain control and functional mobility.

This prospective randomized trial is randomly divided into 3 groups using the method. Total knee arthroplasty is performed by the same surgical team.

is applied. The patients were divided into proximal ACB applied, distal ACB applied and control groups.

Eligibility Criteria:
Inclusion Criteria:

* Medications for unilateral TKA surgery

  * Patients aged 18-85
  * ASA 1-3

Exclusion Criteria:

* Patients under 18 years of age and over 85 years of age
* Patients with ASA 4 and above
* Patients with cognitive impairment
* Patients with application site infection
* Patients allergic to local anesthesia
* Patients receiving anticoagulant therapy
* Patients with bleeding diathesis
* Patients with chronic opioid or substance use
* Patients with insulin-dependent diabetes mellitus
* patients with neuropathy

  * patients with hepatic or renal failure
* Patients who do not accept the procedure to be applied
Reducing Treatment Risk in Older Adults With Diabetes

This study will evaluate the impact of academic detailing (evidence-based provider education) with or without patient pre-visit preparation (elicitation of values and preferences) on safe insulin de-prescribing among older patients with type 2 diabetes at risk for hypoglycemia. The hypothesis is that patients who are well-prepared for their primary care visit will engage in more informed discussions with their providers regarding re-evaluation of current treatment regimens. In clinically appropriate cases, these more effective discussions will result in safe de-prescribing and fewer future episodes of hypoglycemia.

In this comparative effectiveness clinical trial, primary care physicians (PCPs) will receive 2 academic detailing sessions 6 months apart. Eligible patients (age 75 years or greater, type 2 diabetes, prescribed insulin or sulfonylureas \[SUs\], and last measured HbA1c \<=8%) of these PCPs will be randomized to receive either a pre-visit conversation aid/communication tool that elicits values and preferences regarding safe insulin/SU deprescribing \[Intervention\] or a general health education handout ("Embracing Life as You Age") \[Attention Control\]. Patient-reported outcomes (e.g., self-reported hypoglycemia episodes) and clinical outcomes (e.g., changes in glycemic regimen) will be compared between study arms. If successful, this study will provide evidence to support strategies for safer treatment in older adults with type 2 diabetes.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 75 years
* type 2 diabetes with last measured Hemoglobin A1c (HbA1c) ≤ 8.0%
* currently prescribed insulin and/or sulfonylureas (SUs)
* Kaiser Permanente Northern California member

Exclusion Criteria:

* Given the requirements of this funding mechanism, we will not be able to develop new patient materials in languages other than English, and patients unable to communicate in English will be excluded.
* Similarly, patients unable to provide informed consent and/or participate in informed decision making due to cognitive or communication-related deficits will be excluded.
* Excluded by their primary care provider
Remifentanil and Stress Hormones Response

Perioperative adequate analgesia reduces neuroendocrine stress response and postoperative complications. Because opioids are the most effective parenteral drugs to control pain and stress response, in this prospective randomized double-blinded controlled study we supposed that higher dose of remifentanil may reduce stress marker variations compared to lower dose in patients undergoing laparoscopic cholecystectomy.

Fifty Caucasian patients, aged 20-70 years, with American Society of Anesthesiologist physical status I-II, undergoing laparoscopic cholecystectomy were enrolled. Exclusion criteria were: patient refusal, thyroid disorders, diabetes mellitus, BMI \> 30, use of corticosteroids, benzodiazepines or antipsychotics drugs. No patient received premedication. Before entering the operating room, venous access was established (18 G in the antecubital vein) where the first blood sample (Time 0) was collected to measure adrenocorticotropic hormone (ACTH), Cortisol, Growth hormone (GH) and prolactin (PRL) levels. Then a second venous access was established (18 G on the other arm) to start a fluid infusion (normal saline to replace half of the water deficit from preoperative fasting followed by a maintenance infusion of 2 ml/kg/h). Heart Rate (HR), Non Invasive Blood Pressure (NIBP), Bispectral Index (BIS), End-tidal CO2 (EtCO2) were recorded every 5 minutes. Patients were randomly assigned to receive two different dosages of remifentanil: 0,15 mcg/kg/min (group A) and 0,30 mcg/kg/min (group B) for the induction and the maintenance of anesthesia, using a computer generated randomization table (Table I). Anesthesia was induced with propofol 2 mg/kg, cisatracurium 0,15 mg/kg and remifentanil infusion of 0,15 mcg/Kg/min (Group A) or 0,3 mcg/Kg/min (Group B) was started. Anesthesia was maintained with desflurane at a variable concentration in order to maintain the BIS between 40 and 60. The second blood sample was collected at the trocar insertion (Time 1), and the third sample one hour after the end of the surgery (Time 2). Postoperative analgesia was standardized using intravenous acetaminophen 1 g and morphine 0,1 mg/kg 30 minutes before the end of the surgery. Rescue analgesia in Recovery Room was provided by intravenous tramadol 1 mg/Kg.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologist physical status I-II
* Undergoing laparoscopic cholecystectomy

Exclusion Criteria:

* patient refusal,
* thyroid disorders,
* diabetes mellitus,
* BMI \> 30,
* use of corticosteroids, benzodiazepines or antipsychotics drugs
Autonomic Nerve Stimulation Using External Auditory Canal Electrodes

* Purpose of the study This study aimed to investigate electrocardiogram measurement and subthreshold low-level autonomic nerve stimulation using external auditory canal electrodes among healthy adult participants
* Study design Prospective, single-center, interventional, single-arm design
* Study participants A total of 12 healthy adult participants without cardiovascular diseases will be recruited.
* Study methods

  1. Participant enrollment Study participants will be recruited by advertisement posters announced at the lobby of the hospital
  2. Evaluation of electrocardiogram measurement from external auditory canal electrodes Participants are required to attach specially designed external auditory canal electrodes to their both ears to record electrocardiogram. Both electrocardiogram from the precordium and the ear would be simultaneously recorded and compared.
  3. Evaluation of low-level autonomic nerve stimulation using external auditory canal Using the electrodes described above, Arnold's nerve will be stimulated with low-level electric impulses using TENS device. During and after the stimulation, heart rate variability will be measured to investigate the impact of nerve stimulation on autonomic function modulation on the heart.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults without cardiovascular diseases
* Aged 20 years or more with Informed consent

Exclusion Criteria:

* Patients with autonomic disorder, cardiovascular drug prescriptions, cardiovascular diseases, diabetes, or with cardiac implantable electronic devices
* Patients with abnormalities at both external auditory canals and ears
Effect of the Plasma EBV DNA Change During Chemoradiotherapy in Nasopharyngeal Carcinoma

Epstein-Barr virus (EBV) has been proven to process a strong association in patient of nasopharyngeal carcinoma (NPC). Monitoring plasma EBV DNA in NPC patients can provide reliable informations in early detecting tumor recurrence or risk grouping.

EBV DNA has strongly association in NPC patient' disease status. It can provide informations of disease relapse or risks classification. In this study, we will investigate the impact of plasma EBV DNA concentration change during chemoradiotherapy on initial tumor response and long-term survival in patients with advanced nasopharyngeal carcinoma

Eligibility Criteria:
Inclusion Criteria:

1. Histological proven NPC.
2. 2010 American Joint Committee on Cancer (AJCC) stage II-IVB.
3. Age ≧ 20 years old.
4. Performance status of Eastern Cooperative Oncology Group (ECOG) ≦ 2.
5. Adequate liver, renal, and bone marrow functions 5.1 Serum total bilirubin level ≦ 2.5 mg/dl. 5.2 Serum creatinine ≦ 1.6 mg/dl or calculated creatinine clearance rate (CCr) ≧ 60 cc/min.

   5.3 White blood cell count (WBC) ≧ 3,000/micro-ml. 5.4 Platelet count ≧ 100,000/micro-ml.
6. Pre-treatment plasma EBV DNA \> 0 copies/mL
7. Signed informed consent.

Exclusion Criteria:

1. Presence of distant metastasis.
2. Previous radiotherapy or chemotherapy.
3. History of a malignancy except those treated with curative intent for skin cancer (other than melanoma), in situ cervical cancer, ductal carcinoma in situ (DCIS) of the breast.
4. Severe cardiopulmonary diseases (unstable angina and/or congestive heart failure or peripheral vascular disease requiring hospitalization within the last 12 months; chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization) or clinically significant psychiatric disorders.
5. Female patients who are pregnant or lactating.
Neonatal Cerebral Blood Flow and the Neurobehavioral and Handedness Outcomes in Term and Preterm Adolescents

The results will provide insightful information to understand the process of neural development and the predictive value of early cerebral blood flow measures on longitudinal neurodevelopment and handedness outcomes in preterm and term adolescents. The findings also contribute to the understanding of effectiveness of early intervention on long-term neurodevelopmental outcome in preterm children at adolescence.

Our study has three hypotheses as below:

1. The preterm intervention group have higher neuromotor scores, lower behavioral problem scores and higher incidence of right-handedness than the preterm control group.
2. The preterm intervention group have comparable neuromotor scores, behavioral problem scores and incidence of right-handedness than the term adolescents.
3. The neonatal cerebral blood flow velocity asymmetry measures are significantly associated with the infant, preschool, school and adolescent neurodevelopment and handedness outcomes in preterm children with very low birth weight and term children.

The term and preterm children have previously been administered Cranial Doppler Ultrasound and neurobehavioral assessment at term age, and neurodevelopmental assessment in the neonatal period, infancy, preschool and school age (Bayley Scales of Infant and Toddler Development-3rd edition, Movement Assessment Battery for Children-2nd Edition, Child Behavior Check List/4-18, Wechsler Pre-School and Primary Scales of Intelligence-Revised, and Developmental Test of Visual-Motor Integration - 6th Edition).

All families will be contacted via phone call and mail to participate in this study. Children and their parents will be examined for child neuromotor development, handedness and behavior when the children reach 12-14 years of age. All measures will be conducted at the Infant Motor Development Laboratory, School of Physical Therapy, National Taiwan University. The outcome measures in this study will consist of the growth (weight and height), neuromotor function (Movement Assessment Battery for Children-2nd Edition), handedness (Edinburgh Handedness Inventory) and behavior (child report and parent report of Child Behavior Check List for Ages 4-18 Years).

Eligibility Criteria:
Inclusion Criteria:

Joined our previous study

* preterm group: (1) birth weight \<1,500 g; (2) gestational age \<37 weeks;
* term group: (1) birth weight \>2,500 g; (2) gestation age within 38 and 42 weeks; (3) intrauterine growth status as appropriate for gestational age.

Exclusion Criteria:

* Severe neonatal diseases included major neurologic abnormalities, necrotizing enterocolitis, and severe cardiopulmonary disease and major congenital abnormality.
A Virtual Support Intervention for Postnatal Well-being

Postnatal depression (PND) and anxiety are significant public health concerns affecting a substantial proportion of new mothers worldwide. These conditions can have profound consequences for both maternal and infant well-being, including increased risk of

1. maternal morbidity
2. impaired parent-infant bonding
3. long-term developmental challenges for the child.

Despite the prevalence and impact of PND and anxiety, access to timely and effective mental health care for postpartum women remains limited, particularly in resource-constrained settings.

Limited Research: There has been a historical underinvestment in mental health research in Pakistan, especially in maternal mental health.

Cultural Stigma: Mental health issues, particularly postpartum depression, are often stigmatized, leading to underreporting.

Data Infrastructure: Robust data collection and analysis systems for mental health are still developing in Pakistan The rationale for this study is grounded in the significant public health burden imposed by postnatal depression (PND) and anxiety, coupled with the limitations of traditional care models. Despite advancements in maternal and child health, postpartum mental health remains a neglected area in many countries, including Pakistan.

Eligibility Criteria:
Inclusion Criteria:

* Pakistani female aged 18-45 years
* Recent childbirth (within 0-6 weeks)
* Access to a smartphone or computer with internet connectivity
* Able to understand and communicate in Urdu or English
* Willing to provide informed consent

Exclusion Criteria:

* Pre-existing severe mental illness (e.g., schizophrenia, bipolar disorder)
* Current substance abuse or dependence
* Limited or no access to the internet or smartphone
* Inability to understand or communicate in Urdu or English
* Pregnancy complications requiring intensive care
* Infants with severe medical conditions requiring hospitalization
Effect of Social Isolation on Physical Activity Level, and Kinesophobia in Heart Rhythm Disorders During Pandemic

The aim of our study is to examine the effect of social isolation on physical activity level, health literacy and kinesophobia in heart rhythm disorders.

To prevent the spread of COVID-19, states are imposing quarantine measures and sanctions for all citizens to stay at home as much as possible. These measures severely limit physical activity. It is known that physical activity is an important preventive approach for many preventable diseases, especially cardiovascular diseases. Restriction of physical activity, loss of usual routine, and reduced social and physical contact with others can cause feelings of distress, disappointment, and isolation.

In the latest guidelines, increasing physical activity is recommended to prevent heart rhythm disorders and contribute to the effectiveness of treatment.

The aim of our study is to examine the effect of social isolation on physical activity level, health literacy, and kinesophobia in heart rhythm disorders.

Eligibility Criteria:
Inclusion Criteria:

* Having been diagnosed with heart rhythm disorders
* Being clinically stable
* To comply with social isolation rules
* Volunteering to participate in the research

Exclusion Criteria:

* Having a cognitive problem
* Not being literate
Anterolateral Watson Jones Approach Versus Transgluteal Approach for Uncemented Hemi- Arthroplasty in Displaced Femoral Neck Fracture

Hemiarthroplasty is a well established treatment of Femoral Neck Fractures in the Elderly. During the last decade the use of Minimal Invasive Surgical( MIS) approaches have been increasing. Our hypothesis is that Patients with a Femoral Neck Fracture may benefit from a MIS approach.

The study's main objective: The purpose of the study is to test the following hypothesis. Patients 70 to 90 years with a displaced femoral neck fracture, operated with a hemiarthroplasty through an anterolateral approach, have less pain and better patient satisfaction as measured by PROMs than patients operated through the lateral approach.

The study's subsidiary objectives. We aim to shed light on the following subsidiary hypotheses.

1. A hemiarthroplasty inserted through an anterolateral approach gives less bone resorption, as measured by DEXA around the stem, than a hemiarthroplasty inserted via a direct lateral approach.
2. A hemiarthroplasty inserted through an anterolateral approach causes lesser degree of muscle damage, as measured by CK, than a direct lateral approach

Eligibility Criteria:
Inclusion Criteria: Patients 70- 85 Years of Age -

Exclusion Criteria:

Dementia, Infection Not Suitable for Hemiarthroplasty

-