cyrilzakka/clinical-trials huggingface dataset:
Arginine Treatment of Acute Chest Syndrome (Pneumonia) in Sickle Cell Disease Patients

This is a study to determine if oral arginine will increase nitric oxide in sickle cell disease (SCD) patients with acute chest syndrome (ACS). It will also assess the effects of arginine in the body and how the body uses nitric oxide in ACS.

Pneumonia in patients with SCD can be particularly severe and has come to be called acute chest syndrome. ACS is a common cause of morbidity in SCD patients and is the most common cause of death in SCD. Multiple factors are involved in the severity of acute pulmonary injury in SCD. Nitric oxide has a multitude of related functions, many of which could impact favorably on ACS in SCD. Nitric oxide is an important inflammatory mediator which is produced by the conversion of L-arginine to citrulline by nitric oxide synthase. Nitric oxide and its precursor, arginine, are known to be low in SCD patients with ACS, suggesting that therapies, such as arginine, aimed at increasing nitric oxide production will improve the clinical course of ACS. Patients will receive 1 of 3 doses of arginine hydrochloride orally 3 times a day for 3 days while hospitalized. The efficacy of arginine will be measured by the increase in nitric oxide production and the physiological effects will be assessed.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility Criteria:
Inclusion criteria:

* Diagnosis of sickle cell disease (Hb SS, SC, or Sbeta thalassemia)

Acute chest syndrome with the following:

* New pulmonary infiltrate on chest radiography involving a full segment of the lung and 1 of the following:
* Fever
* Cough, tachypnea, retractions, rales, or wheezing
* Chest pain

Exclusion criteria:

* Inability to take or tolerate oral medications
* Hepatic dysfunction (SGPT greater than 2 times normal)
* Renal dysfunction (creatinine greater than 2 times normal)
* Mental status or neurological changes
* Allergy to arginine
* History of priapism
* Pregnancy
Autologous Mesenchymal Stromal Cells and Islet Co-transplantation in TP-IAT

This is a clinical trial for chronic pancreatitis (CP) patients undergoing total pancreatectomy with islet autotransplantation (TP-IAT). Participants will be randomized to either bone marrow-derived mesenchymal stem cells (MSCs) or control with the standard of care. Participants will be followed for one-year post-transplant.

This will be a randomized, controlled clinical trial for CP patients scheduled to undergo a TP-IAT surgery. Those who are consented will be randomized into one of three groups. One group will receive islet transplantation alone, a placebo. The other two groups will receive islets plus autologous bone marrow-MSCs at two different doses (20x10\^6/patient, or 50x10\^6/patient). The TP-IAT procedure will remain as routinely performed. Patients will be followed for12 months post-transplantation, having 3 follow-up visits scheduled on days 90, 180, and 365 after the transplant. The primary endpoint will be a change in islet function from baseline to 12 months post-transplantation as measured by the C-peptide area under the curve following a mixed meal tolerance test. Potential effects of MSCs on glycemic control, pain relief, quality of life, and adverse events will be evaluated at each follow-up visit.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of CP and scheduled for TP-IAT;
* ≥18 years old;
* Diabetes with HbA1c \<12%.

Exclusion Criteria:

* Patients who are under immunosuppression;
* Pregnant and breastfeeding women.
* Patients who have liver damage based on ALT, AST, and total bilirubin levels (\>3 times normal levels);
A Study Using Imaging Technology to Measure Changes in Bone Structure After Treatment With Teriparatide

The purpose of this study is to use imaging technologies to demonstrate the effects of teriparatide on bone structure following 18 to 24 months of therapy in postmenopausal women with osteoporosis.

As teriparatide is approved for up to 24 months of treatment in the US, patients will be given the option to continue in a 6-month extension phase upon completion of 18 months of teriparatide treatment. This extension will allow for collection of additional bone quality data. In Canada, the use of teriparatide is currently approved for 18 months. Patients in Canada may be given the opportunity to participate in the 6-month extension phase, contingent upon Health Canada approval of the use of teriparatide treatment for 24 months.

Eligibility Criteria:
Inclusion Criteria:

* postmenopausal (after the "change of life") women with osteoporosis
* between the ages of 45-85
* have low bone mass as determined by a bone density test
* have at least one prior atraumatic vertebral or nonvertebral fracture(with a T-score of -2.0 or lower at the lumbar spine, total hip, or femoral neck) or, no prior fracture (with a T-score of -3.0 or lower at these same sites)
* could have taken up to 5 years total of certain oral osteoporosis medications such as alendronate, risedronate, or ibandronate

Exclusion Criteria:

* have conditions that would affect the bone in the region of the wrist or have had a previous fracture of either wrist which might affect results of study
* have a metal implant or have had a hip replacement in either hip which might affect results of study
* have an increased risk of osteosarcoma; includes Paget's disease of bone, a previous bone tumor, or x-ray treatment to the skeleton
* currently have active or suspected diseases that affect the bone, other than osteoporosis
* have abnormal levels of calcium, parathyroid hormone in blood, or other laboratory values
Hyperglycemia in Renal Transplantation

Based on multiple prior studies, kidney transplant recipients with diabetes are at higher risk for poor initial graft function after transplant. Our study is designed to determine if tight blood sugar control around the time of kidney transplant will improve short term graft function.

Population- Our study population will include all adult diabetic patients undergoing deceased donor renal transplantation or living donor transplantation in which a swap requires transportation and resulting cold storage time. This will ensure a reasonable incidence of our primary outcome (poor short term graft function) and eliminate the potential risk of treating non-diabetic patients with insulin infusions. Patients already enrolled in a drug trial designed to study the impact of the drug on graft function will be excluded.

Study Design- This will be a randomized control trial. Recipients will be randomized to either tight peri-operative glucose control or standard management.

Methods

Randomization Protocol- In order to ensure that patients are equally distributed between groups, we will use block randomization. Blocks of 4 patients will be created with the total number of experimental versus control assignments being equal across blocks. Patients will then be randomly assigned to a block.

Interventions- The study group will be treated with an insulin infusion to achieve tight glycemic control (100-140mg/dL). Each study patient will be started on an insulin infusion prior to their operation. This infusion will continue throughout the operation and for 24 hours after completion of the transplant. Glucose control will then be left to the discretion of the primary team.

The control group will be treated with bolus insulin based on a standard insulin sliding scale.

Outcomes

Aim 1-

Primary endpoint- Our primary endpoint will be poor initial graft function defined by the occurrence of DGF (defined by a decrease in serum creatinine of \<10%/day for 3 consecutive days after transplant) or slow graft function (serum creatinine \>3 mg/dL 5 days after transplant without dialysis)

Secondary endpoint- Secondary endpoints will include wound infection, length of hospital stay, 30 day mortality, hypoglycemic episodes(glucose \<70 mg/dL) and stroke.

Aim 2-

Primary endpoint- Our primary endpoints will be acute rejection at 90 days and graft survival/renal function at 3months, 6months and then yearly.

Statistical Analysis- Data will be described as means with standard deviations or percentages with ranges based on whether the data represent continuous or categorical variables. The t-test and chi-squared test will be used to test hypotheses.

Eligibility Criteria:
Inclusion Criteria:

* adult patients
* diabetic
* end stage renal disease undergoing cadaveric renal transplant

Exclusion Criteria:

* enrolled in concurrent study to test impact of a drug on graft function after transplant
SAY San Diego Dad Corps FIRE Program Evaluation

The purpose of the SAY San Diego Dad Corps FIRE program evaluation is to determine whether primary (i.e., behaviors) and secondary (i.e., attitudes) outcomes around parenting, co-parenting, employment, job readiness, and financial stability improve for participants after completing the SAY SDDC FIRE program.

After being informed about the study and giving consent, participants will enroll in an eight-week program that collects data at enrollment, at the end of the program, and 12 months following the program. Research questions in this study are framed by a descriptive evaluation design to assess whether outcomes improve for low-income fathers who participate in the SAY SDDC FIRE program. Primary and secondary outcomes are assessed before and after participants complete core curricula - 24/7 Dads, Healthy Relationships, and Economic Stability workshops (pre to post). Primary outcome measures will indicate whether behaviors improved for healthy family relationships (parent, co-parent, and partner) and economic stability (financial, employment). Secondary outcome measures will indicate whether improvements were made in the attitudes and expectations that facilitate and reflect behavior for healthy partner relationships and financial stability.

Eligibility Criteria:
Inclusion Criteria:

* Adult (age 18 and older)
* Father/father figure
* Has a child under the age of 24
* Reside in the San Diego, CA area

Exclusion Criteria:

* Minor (under the age of 18)
* Not a father/father figure
* Fathers with children over the age of 24
* Reside outside of San Diego, CA area
Effectiveness of Anti-Inflammatory Drugs for Preventing Pain Versus Treating Pain During Medical Abortion From 13 to 22 Weeks at Hung Vuong Hospital

The goal of this clinical trial is to assess the effectiveness of non-steroidal anti-inflammatory drugs (NSAIDs) for prophylactic pain relief compared to on-demand pain relief during medical abortion for pregnancies between 13 and 22 weeks at Hung Vuong Hospital in Ho Chi Minh City. The main questions it aims to answer are:

1. Does prophylactic use of NSAIDs reduce pain compared to on-demand use during medical abortion?
2. What are the potential adverse effects of NSAIDs in this context?

Researchers will compare a group receiving prophylactic NSAIDs to a control group receiving on-demand pain relief to determine if the prophylactic approach leads to improved pain management outcomes.

Participants will:

* Be given NSAIDs either as a preventative measure or upon the onset of pain.
* Be monitored for pain levels using validated pain scales, any side effects, and outcomes of the abortion procedure.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women aged 18 years or older.
* No mental illness.
* Gestational age between 13 and 22 weeks (based on the last menstrual period with a regular menstrual cycle and accurate recall of the last menstrual period, or based on a first-trimester ultrasound) with an indication of stillbirth, fetal malformation requiring termination, or voluntary abortion with counseling and understanding of the abortion procedure.
* Willing to participate in the study.
* Capable of reading and signing the informed consent form.
* Able to provide personal information independently.

Exclusion Criteria:

* Medical conditions contraindicating medical abortion: bleeding disorders, anticoagulant use, moderate to severe anemia.
* Cardiovascular conditions: heart failure, mitral valve stenosis, embolism, uncontrolled hypertension.
* Other medical conditions: renal failure, adrenal gland disorders, severe asthma, liver and biliary diseases, glaucoma.
* Active pelvic inflammatory disease or acute genital infections.
* Previous uterine surgery.
* Placenta previa or central placenta previa.
* Uterine malformations.
* History of allergy to NSAIDs, Mifepristone, or Misoprostol.
* Unwillingness to participate in the study.
ANASA (Patients' Satisfaction With Pulmonary Diseases' Treatment)

The aim of the study is to compare patients' satisfaction from the use of three different inhalation devices by using the FSI-10 questionnaire

Patients are requested to reply to FSI-10 questionnaire regarding their satisfaction from inhalation devices. Patients are on 3 different asthma inhalation devices with combination treatment (Turbuhaler, Diskus, Elpenhaler)

Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 years old, both genders who are on their inhalation treatment at least two months before study enrollment,
* Who are able to be compliant to study procedures

Exclusion Criteria:

* Patients \< 18 years old,
* Patients who are on their inhalation treatment less than two months before study enrollment
* Patients who are not able to be compliant to study procedures
Effects of Blueberry on Gut Microbiota and Metabolic Syndrome

There is growing evidence that nutritional intervention with dietary polyphenols can positively modulate the gut microbiota to improve cardiometabolic health. Whether the beneficial effects of blueberries on obesity and the metabolic syndrome can be linked to their potential impact on the gut microbiota and intestinal integrity remains speculative at this time. Moreover, the mechanisms of action underlying health benefits associated to blueberry consumption are still unknown. The investigators are thus proposing to combine the study of metagenomics, transcriptomics and metabolomics to test whether a prebiotic activity of highbush blueberries can play a role in the prevention of obesity-linked metabolic syndrome in a clinical setting.


Eligibility Criteria:
Inclusion Criteria:

* Men and premenopause women in good health
* Caucasians
* At least one of the following : BMI between 25 and 40 kg/m2 or Waist circumference ≥ 80 cm for women and ≥ 94 cm for men
* At least one of the following : TG ≥ 1.35 mmol/L or fasting insulinemia ≥ 42 pmol/L

Exclusion Criteria:

* Metabolic disorders (hypertension, diabetes, hypercholesterolemia)
* Regular use of medication affecting study parameters
* Use of natural health product in the last 3 months
* Use of antibiotics in the last 3 months
* Nicotine users
* Allergy or intolerance for blueberries
* Blueberry taste aversion
* More than 2 alcohol drinks par day
* Particular dietary habits (vegetarism, gluten-free diet, cetogenic diet...)
* Weight change of more than 5% in the last 3 months
* Surgery in the last 3 months or planed during the study
Light and Exercise in Night-shift Workers

EuRhythDia is a multicenter, controlled and randomized study. The aim of the study is to investigate the effects of 12 weeks of randomized timed light therapy or timed physical exercise as a chronotherapeutic lifestyle intervention on markers of central and peripheral circadian rhythms and cardiometabolic function in healthy night shift workers.

Lifestyle interventions have been recognized as important means to prevent and treat cardiometabolic disease. However, compliance of the European population to general recommendations of exercise and weight loss is unsatisfactory. There have been no studies that have attempted to convert the exciting new experimental data on the circadian clock, lifestyle, and cardiometabolic risk into diagnostic tools or novel therapeutic approaches via structured multidisciplinary efforts. One of the aims of the EuRhytDia study is to study novel applications of established lifestyle interventions by co-ordinating the timing of interventions with circadian rhythmicity.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects above the age of 18
* Night shift workers on regular night shifts with at least 3 nights in a row per month during the study period
* Subjects must have been on night shifts for at least 4 weeks before inclusion into the study
* Signed written informed consent

Exclusion Criteria:

* Regular use of drugs (prescription or non-prescription, exception: contraceptives) or dietary supplements within 4 weeks before inclusion of the study
* Pregnancy or breast feeding
* Any severe somatic or psychic disease (malignant or non-malignant
* Any known ophthalmological condition that prevents the exposure to bright light (e.g. cataract, glaucoma, retinopathy, macular degeneration, acute eye infections, lesions of the cornea)
* Any skin condition or use of drugs associated with increased photosensitivity;
* Any kind of disability that would prevent the subjects from participation in exercise training sessions
Comparative Study on Surgical Approaches for Elderly Femoral Neck Fractures

A prospective controlled study was conducted to include patients who received hip replacement surgery for femoral neck fractures at the National Regional Trauma Center in Fujian Province from February 2023 to August 2024. Patients were randomly divided into the DAA group and the PLA group based on different surgical methods for a 3-month follow-up to compare the outcomes of the two groups. The main observation results include Harris hip joint function score (preoperative, postoperative 1 week, 1 month, 3 months), VAS pain score (preoperative, postoperative 1 week, 1 month, 3 months), and secondary observation results include surgical time, intraoperative blood loss, blood transfusion rate, difference in HB before and after surgery, difference in CK before and after surgery, perioperative complications, difference in length of both lower limbs after surgery, postoperative drainage volume, postoperative ICU occupancy rate, ICU length of stay, and total length of stay.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 80 years old;
2. Diagnosed with unilateral femoral neck fracture through imaging examination;
3. Patients who can tolerate surgery and agree to undergo surgery;
4. Undergoing hemiarthroplasty (HA) for the first time;
5. Able to walk independently and have intact cognitive function before the injury.

Exclusion Criteria:

1. Bilateral femoral neck fractures;
2. Patients with pathological fractures;
3. Hip dysplasia, rheumatoid osteoarthritis, or other hip disorders;
4. Patients with systemic or localized infections or inflammatory reactions at the surgical site;
5. Patients with other lower limb fractures or severe injuries to other parts of the body; Patients with a history of previous hip surgery.
The Analgesic Effect of Pericapsular Nerve Group Block With Lateral Femoral Cutaneous Nerve Block and Pericapsular Nerve Group Block With Supra-inguinal Fascia Iliaca Block in Hip Hemiarthroplasty

The aim of this study is to investigate the efficiency of preoperative and post-operative analgesia by pericapsular nerve group block (PENG) block with supra-inguinal fascia iliaca block (SIFIC) block compared with PENG block with lateral femoral cutaneous nerve block (LFCN) block in ease of giving a sitting position for spinal anesthesia and reducing narcotic consumption during the first 24 hour post-operatively and functional recovary by using the Visual analogue scale (VAS) of pain.

The established practice to decrease pain using opioids in hip fracture surgery may result in compromised outcomes in the frail and elderly population with nausea-vomiting, constipation, delirium and respiratory depression. This popularized the regional analgesic techniques in the surgical treatment of hip fractures. Femoral nerve (FN) and supra-inguinal fascia iliaca block (SIFIC) block are documented to provide good peri-operative analgesia with reduced need for opioids.

The latest pericapsular nerve group block (PENG) block, is an interfacial plane block targeting the articular branches of the femoral, obturator (ON) and accessory obturator nerves (AON) at the hip.

An ability to perform in supine positioning, which is especially important in patients with acute hip fractures or chronic pain is an indigenous advantage of PENG block. Due to the blockade of only sensory articular branches, substantial motor weakness is unexpected. But exclusive use of PENG block for analgesia in hip fracture patients is not sufficient as it doesn't involve the cutaneous pain-generating area supplied by the lateral femoral cutaneous nerve block (LFCN).

Eligibility Criteria:
Inclusion Criteria:

* Age 40-80 years.
* Sex: Both sexes.
* American Society of Anaesthesiologists (ASA) Physical Status Class I, II, and III.
* Scheduled for hip hemiarthroplasty under general anesthesia.

Exclusion Criteria:

* Declining to give a written informed consent.
* History of allergy to the medications used in the study.
* Contraindications to regional anesthesia (including patient refusal, coagulopathy and local infection).
* Psychiatric disorders or narcotic abusers.
* Significant cognitive dysfunction.
* American Society of Anesthesiologists (ASA) Physical Status Class IV.
* Renal insufficiency (to avoid local anesthetic or nalbuphine metabolites adverse effect)
* Opioid abuser patients
* Pregnancy.
Anidulafungin PK in Infants and Toddlers

This is a prospective, open-label, single center, pharmacokinetic study of anidulafungin in infants and toddlers less than 24 months of age with suspected serious infection. There will be up to 24 subjects enrolled; each will receive anidulafungin. Patients will receive anidulafungin 3 mg/kg loading dose on day 1 of study and will receive 1.5 mg/kg every 24 hours on study days 2-5.Plasma pharmacokinetics will be evaluated using a limited sampling scheme. We hypothesize that the PK parameters of anidulafungin will not differ from those observed in older children and adults.


Eligibility Criteria:
Inclusion Criteria:

* Age \< 24 months at the time of enrollment
* Patient must have sufficient venous access to permit administration of study medication
* Infant or toddler suspected to have a serious infection and from whom a blood culture has been obtained with 48 hours of study entry
* Availability and willingness of the parent/legally authorized representative to provide written informed consent.

Exclusion Criteria:

* Patients with a history of anaphylaxis attributed to an echinocandin
* Any other concomitant condition, which in the opinion of the investigator would preclude a patient's participation in the study
* Previous participation in this study
* Previous exposure to an echinocandin in the month prior to study.