cyrilzakka/clinical-trials huggingface dataset:
Postpartum Care Timing: A Randomized Trial

The purpose of this study is to determine if shortening the time to initial postpartum visit from six weeks to two weeks can improve clinic visit attendance and decrease usage of the emergency department.

Postpartum care is an integral component to completing the maternal peripartum experience and transitioning the patient to well-women care. The American Congress of Obstetrics and Gynecology has recently highlighted the importance of this "fourth stage" of pregnancy suggesting earlier and more comprehensive visits compared to the standard 6-week postpartum visit. Specifically they describe that "all women should ideally have contact with a maternal care provider within the first three weeks postpartum" however this is largely derived from expect opinion and retrospective data. The current rate of postpartum visit attendance is as low as 66%, especially in women with scant prenatal care. In the investigators government-funded clinic, the postpartum clinic attendance in 2017 was 69% and many of the patients have co-morbidities, notably a 25% rate of psychiatric illness. Additionally, in this population, the investigators have identified a high rate of Emergency Department (ED) usage (8.7%) within 30 days of delivery suggesting that perhaps an earlier routine visit is ideal and can prevent the use of the ED. The aim therefore is to evaluate the utility of an early postpartum visit at two weeks in addition to a standard six-week visit with a randomized control trial.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Receives antepartum, intrapartum and postpartum care at UCLA
* Speaks English or Spanish
* Provides informed consent for study participation
* Vaginal, cesarean delivery or operative vaginal delivery

Exclusion Criteria:

* Cognitive impairment, psychiatric instability, or language barriers that limit her ability to provide informed consent
* Plans to received postpartum care at other institution
Dexmedetomidine in Mechanically Ventilated Neonates With Single-Organ Respiratory Failure.

Clinical experience with dexmedetomidine in the paediatric population is limited. Critical illness can affect drug pharmacokinetics and -dynamics; the investigators cannot simply extrapolate adult data for use in children but the investigators are in need of data on pharmacokinetics and pharmacodynamics in every paediatric subpopulation.

Currently, dexmedetomidine is approved by the United States Food and Drug Administration (FDA) for short-term analgosedation (\<24h) in mechanically-ventilated critical care adult patients and sedation of non-intubated adult patients prior to and/or during surgical and other procedures. Trials are underway to investigate its pharmacokinetics, clinical efficacy and safety in long-term use. Clinical experience with dexmedetomidine in the paediatric population is limited. Moreover, during childhood many developmental changes take place with consequences on drug exposure and drug response. Finally, critical illness itself can affect drug pharmacokinetics and -dynamics. Therefore, the investigators cannot simply extrapolate adult data for use in children but the investigators are in need of data on pharmacokinetics and pharmacodynamics in every paediatric subpopulation.

Eligibility Criteria:
Inclusion Criteria:

* patient age less than 1 month (Male/Female) (step-down strategy for age)

  * first included patients (n=30): postmenstrual age \>= 34 weeks (near-term neonates)
  * following included patients (n=30) : postmenstrual age \>= 25 weeks and \< 34 weeks (preterm neonates)
* patients with single-organ respiratory failure in need for analgosedation (guidance : Comfort neo score \>14 or Numeric Rating Scale (NRS) score Pain (P)/Comfort (C)\>4)
* patients admitted to the neonatal intensive care unit
* expected to require at least 20 hours of mechanical ventilation

Exclusion Criteria:

* patients with neurologic conditions that prohibit an evaluation of adequate analgosedation
* no arterial catheter in place at inclusion
* patients who have received another investigational drug within 30 days
* patients on continuous infusion with neuromuscular blockers
* patients with a life expectancy \<72 hours
* patients with a known allergy to fentanyl
* congenital or acquired heart block (grade 3)
* sustained bradycardia
* haemodynamically unstable patients (definition : Mean Arterial Pressure (MAP) lower than : postmenstrual age (in weeks) - 5 millimeter Hg, eventually under dopamine infusion max. 16 mcg/kilogram/minute and/or dobutamine infusion maximal 16 mcg/kilogram/minute)
* patients with significant renal insufficiency (creatinine plasma level \>1.5 milligram/deciliter)
* patients with significant hepatic insufficiency (as estimated by local investigators)
* previous treatment with α2-adrenoreceptor agonist clonidine within 14 days
* absence of parental consent
Theory-based Intervention for Promoting Responsible Gambling Among College Students

The goal of this clinical trial is to learn if the RESPONSIBLEPLAY© intervention helps promote responsible gambling behaviors in University of Nevada, Las Vegas (UNLV) students aged 21 and older who have a Problem Gambling Severity Index (PGSI) score of 3 or higher. The main questions it aims to answer are:

Does the intervention reduce harmful gambling behaviors? Does the intervention increase responsible gambling practices? Researchers will compare participants receiving the RESPONSIBLEPLAY© intervention with those receiving a knowledge-based intervention to see if the RESPONSIBLEPLAY© intervention is more effective.

Participants will:

Attend three face-to-face sessions on responsible gambling over three weeks. Complete surveys before, after, and eight weeks after the intervention to track their progress.

This study investigates the efficacy of the RESPONSIBLEPLAY© intervention, designed to promote responsible gambling behaviors among college students at UNLV. College students are a vulnerable group for developing gambling-related problems, with a significantly higher prevalence of problem and pathological gambling compared to the general population. This randomized controlled trial (RCT) will compare the RESPONSIBLEPLAY© intervention, which is based on the Multi-theory Model (MTM) of health behavior change, to a traditional knowledge-based intervention.

The RESPONSIBLEPLAY© intervention addresses both the initiation and sustenance of behavior change, incorporating elements such as participatory dialogue, behavioral confidence, and changes in the social and physical environments. The intervention aims to equip participants with practical strategies to manage and limit gambling behaviors.

The study will take place over a three-week period, with face-to-face sessions designed to engage participants in discussions and self-guided activities that promote responsible gambling. Follow-up assessments will be conducted at eight weeks post-intervention to evaluate the long-term impact of the intervention. A two-factor repeated measures analysis will be used to assess changes in gambling behaviors and related psychological constructs over time.

The findings from this study may provide critical evidence to support the use of theory-based interventions to reduce gambling-related harms in a college student population, which can inform future public health strategies.

Eligibility Criteria:
Inclusion Criteria:

* Must be at least 21 years old.
* Must be a enrolled UNLV student.
* Must engage in gambling activities.
* Must have a score of 3 or higher on the Problem Gambling Severity Index (PGSI), indicating at-risk or problem gambling behavior.

Exclusion Criteria:

* Participants currently receiving treatment for gambling disorders.
* Individuals with cognitive impairments that would affect their ability to provide consent or participate in the intervention.
* Individuals who are not fluent in English (since the intervention materials and assessments will be conducted in English).
Multiple Sclerosis Produces Cardiovascular Subclinical Dysfunction

Multiple sclerosis (MS), debilitating disease involving primarily the central nervous system, may cause cardiovascular dysfunction, due to autonomous nervous system dysfunction, physical invalidity, increased oxidative stress, and systemic inflammatory status, but the detailed mechanisms are not elucidated. The investigators aimed to assess left and right ventricular (LV and RV) function, left atrial (LA) function, arterial function, and atrial-ventricular-arterial coupling in patients with MS, compared to control subjects. LV systolic and diastolic function and RV function were assessed by 2D- and 3D- echocardiography, tissue Doppler, and speckle tracking echocardiography. LA function was assessed by LA volume index and LA strain. Arterial remodeling and stiffness were assessed by intima media-thickness, pulse wave velocity, and parameters of wave intensity and endothelial function


Eligibility Criteria:
Inclusion Criteria:

1. age between 18 and 65 years;
2. patients with confirmed MS diagnosis, both newly diagnosed or already under immunomodulatory treatment;
3. informed consent signed.

Exclusion Criteria:

1. MS treated with mitoxantrone;
2. patients with known cardiovascular disease;
3. presence of other neurological conditions;
4. any renal, pulmonary, hepatic or hematological disease;
5. diabetes mellitus;
6. any degree of arterial hypertension;
7. pregnancy;
8. and difficult acoustic window
The Role of Peptide YY (PYY)in Inhibiting Food Intake.

12 obese subjects will receive peripheral administration of placebo and 4 escalating doses of PYY1-36 and another 12 obese subjects will receive peripheral administration of placebo and 4 escalating doses PYY3-36 on 5 different test days within one week. The patients will be tested in a single blinded dose escalating protocol. Measurements of appetite, ad libitum energy intake, blood pressure and blood sampling will be performed during the test day.


Eligibility Criteria:
Inclusion Criteria:

* Normal weight (BMI: 18-23 kg/m2) or 12 overweight/obese (BMI: 27-40 kg/m2)
* Body weight fluctuations \< 5 kg over the past 2 months.
* Blood pressure normal to mildly hypertensive(\<159/99 mm Hg)
* Non-elite athletes and not planning to change physical activity during the study.

Exclusion Criteria:

* Any physiological or psychological illnesses that could influence the study results.
* Regular use of medicine.
* Smoking defined as \<1 cigarette per day.
* Substance abuse or dependence.
* Blood donation within the past 3 months before entering the study.
* Drinking \>21 alcoholic units/week.
* Food allergies.
* Special diets (e.g. vegetarian) or dislikes to any of the foods served during the study.
TKI Therapy Based on Molecular Monitoring in Allogeneic-HSCT Recipients With Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia

The purpose of this study is to evaluate the efficacy of tyrosine kinase inhibitor(TKI) therapy based on molecular monitoring of BCR/ABL levels in Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL)undergoing allogeneic hematopoietic stem cell transplantation(allo-HSCT).

Philadelphia chromosome (Ph) is a reciprocal chromosomal translocation t(9;22）(q34;q11), which leads to the formation of the BCR/ABL oncogene. Ph is the most frequent cytogenetic abnormality in ALL characterized by poor outcome. With the BCR/ABL protein TKI, imatinib, in the combination chemotherapy regimes for newly diagnosed Ph+ ALL, more than 95% of patients can achieve complete remission(CR). Several studies have shown decreased relapse rates and improved disease-free survival for patients with imatinib-based treatment prior to allo-HSCT. However, the efficacy of maintenance therapy with imatinib after transplant for Ph+ ALL patients is still uncertain. In addition, acquired resistance to imatinib is frequently caused by point mutations in BCR/ABL that inactivate imatinib.

Detection of minimal residual disease (MRD) after transplant is associated with an increased risk of relapse. Reverse transcription-polymerase chain reaction (RT-PCR) is a sensitive method for detecting low-level BCR/ABL transcripts to assess MRD in Ph+ ALL. It has been corroborated by several reports that detection of MRD after SCT was predictive of imminent relapse.

In this study, we will evaluate the safety and efficacy of TKI therapy, when initiating treatment based on BCR-ABL transcript levels after allo-HSCT.

Eligibility Criteria:
Inclusion Criteria:

* A patient age of 14-65 years
* Allo-HSCT recipient with ph+ ALL
* Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.

Exclusion Criteria:

* Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
* patients with hematological relapse, extramedullary involvement of leukemia
* Patients with any conditions not suitable for the trial (investigators' decision)
A Phase III Trial of Carboplatin as Adjuvant Chemotherapy in Triple Negative Breast Cancer

This study is designed to investigate the efficacy of carboplatin, as a post-operative adjuvant chemotherapy for triple negative breast cancer patients who have pathologic residual cancer after the preoperative chemotherapy.

In Neo-adjuvant period Four cycles of 60 mg/m2 doxorubicin and 600 mg/m2 cyclophosphamide therapy at 3-week intervals followed by four cycles of 100 mg/m2 docetaxel at 3-week intervals.

In POST Neo-adjuvant period

Randomization:

At the time of post neo-adjuvant period, the patients will be assigned to each treatment group in a 1:1 ratio i.e. carboplatin AUC 6 group vs. observation group. Six cycles of carboplatin (AUC=6) on the first day of every 21 days.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of breast cancer

  1. Female patients
  2. Histologically confirmed invasive breast cancer

     1. Primary tumor greater than 2cm diameter, measured by mammography and sonography
     2. Any N
  3. ER (estrogen receptor)/ PR (progesterone receptor) / HER2 (negative/ negative/ negative)(ER \<1%, PR\<1%, IHC 0, 1+ or FISH - in case of IHC (immuno-histochemistry) 2+)
  4. No evidence of metastasis (M0)
  5. No prior hormonal, chemotherapy or radiotherapy is allowed.
  6. No breast operation other than biopsy to make diagnosis is allowed.
  7. Age: 20-years and older, not pregnant pre-, and postmenopausal women with good performance status (ECOG 0-1)
  8. Adequate hematopoietic function: Absolute granulocyte count 1500/mm3, platelet 100,000/mm3, Hemoglobin 10 g/mm3
  9. Adequate renal function: Serum creatinine 1.5 mg/dl
  10. Adequate hepatic function: total bilirubin: 1.5 mg/dl, AST(aspartate aminotransferase)/ALT (alanine transaminase): 2 times normal, Alkaline phosphatase:2 times normal
  11. Written informed consent
  12. Normal mental function to understand and sign the consent
  13. Cardiac function: normal or nonspecific EKG taken within 1 mo of enrollment.
  14. LVEF (left ventricular ejection fraction)50% by MUGA (multiple gated acquisition scan) or Echocardiogram taken within 1 mo of enrollment

Exclusion Criteria:

1. Patients who received hormonal, chemotherapy or radiotherapy for breast cancer
2. Patients who underwent surgery for breast cancer
3. Patients with a history of uncompensated congestive heart failure
4. Patients with inflammatory breast cancer (T4d)
5. Patients without primary tumor (T0)
6. Patients who have history of cancer other than in situ uterine cervix cancer or non-melanotic skin cancer
7. Known hypersensitivity to any of the study drugs
Evaluation of the Efficacy of Surfaktant in Preterm Infants by Lung Ultrasound

To compare the lung ultrasound scores after two different natural surfactant administration as a parameter reflecting lung inflation. Poractant alfa decreases lung ultrasound scores as efficient as beractant treatment

Outcomes:

Improvement of Lung usg scores after surfactanct and the difference between groups at different time points (2nd and 6hr).

Secondary outcome:

The correlation between lung usg scores and clinical scores (silverman scores), FiO2 and PCO2 levels, failure of weaning to noninvasive ventilation after surfactant Preterm infants of 32 gestational weeks and below, who admit to the NICU with signs of respiratory distress, treated with non invasive or mechanical ventilation and require surfactant treatment in 6 hours of life will be enrolled.

Eligibility Criteria:
Inclusion Criteria:

* Preterm infants of 32 gestational weeks and below, who admit to the NICU with signs of respiratory distress, treated with non invasive or mechanical ventilation and require surfactant treatment in 6 hours of life will be enrolled.

Exclusion Criteria:

* major congenital anomalies.
Alternate-Day Buprenorphine. Phase V - 6

The purpose of this study is to evaluate buprenorphine blockade challenge.


Eligibility Criteria:
Please contact site for information.
A Safety, Tolerability, and Efficacy Study of IBI314 in Patients With Mild to Moderate COVID-19

This is a Phase 1/2 study evaluating the safety, tolerability and efficacy of IBI314.

Phase 1 is a randomized, double-blind, placebo-controlled, single ascending dose study in up to 24 health volunteers. This phase of the study is designed to assess the safety, tolerability and PK of IBI314 administered as a single IV infusion. Phase 2 is a randomized, double-blind, placebo-controlled expansion study in approximately 198 mild to moderate adult patients with COVID-19. This phase of the study is designed to assess the efficacy, safety, PK and PD of IBI314.

Eligibility Criteria:
Main Inclusion Criteria:

First onset of COVID-19 symptoms \<7 days at randomization, symptoms such as fever and/or chills, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, and diarrhea.

Have a positive SARS-CoV-2 Reverse Transcription-Polymerase Chain Reaction (RT-PCR) test using an appropriate sample such as nasopharyngeal (NP), nasal, oropharyngeal, or saliva within 72 hours prior to randomization. A historical record of a positive result from a test conducted ≤72 hours prior to randomization is acceptable.

Male or female patients ≥18 years of age at the time of signing informed consent.

Agree to use an adequate method of contraception throughout the study period and for 6 months after the dose of study drug is administered.

Women of childbearing potential (WOCBP) must have a negative urinary pregnancy test at screening.

Main Exclusion Criteria:

Have oxygen saturation (SpO2) ≤93 % on room air at sea level or a ratio of arterial oxygen partial pressure (PaO2 in millimeters of mercury) to fractional inspired oxygen (FiO2) \<300, respiratory rate ≥30 per minute, heart rate ≥125 per minute.

Have evidence of multi-organ dysfunction/failure. Systolic blood pressure \<90 mmHg, diastolic blood pressure \<60 mmHg, or requiring vasopressors.

Require or anticipated impending need for endotracheal intubation, mechanical ventilation, oxygen delivered by high-flow nasal cannula noninvasive positive pressure ventilation, extracorporeal membrane oxygenation (ECMO).
Gingival Depigmentation Using Diode Laser 940nm Versus 980nm

is study aimed to evaluate the effectiveness of two diode lasers of different wave lengths 940nm and 980nm for the treatment of physiologic gingival melanin hyperpigmentation.


Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes diagnosed clinically with physiologic gingival pigmentation.
* Pigmentation extending from canine to canine in either upper or lower arch.

Exclusion Criteria:

* Smokers.
* Patients with uncontrolled metabolic disease.
* Immuno-compromised patients.
* Patients with renal disease.
* Patients having coagulation disorders.
* Pregnant and lactating women.
* Evidence about the relation of pigmentation with malignancies.
* History of previous treatment of gingival pigmentation.
Utilization of Different Virtual Reality Experiences

This trial studies differences between a mindfulness and a gaming virtual reality (VR) experience as a means for preoperative anxiety management and postoperative pain management among patients after head and neck surgery. Investigators will assess differences in anxiety scores, pain scores, physiologic measures, and subjective patient experiences.

Optimal postoperative pain control after head and neck surgery is vital for recovery, and non-pharmacologic strategies to improve pain may help reduce narcotic use. Further, preoperative anxiety is common and can impact postoperative pain, analgesic requirements, and recovery. In addition to facilitating with postoperative pain control, VR may have a role in reducing preoperative anxiety. However, it is unclear whether different VR experiences may be more beneficial for different clinical applications.

This study will evaluate if there are differences in preoperative anxiety and postoperative pain when utilizing different VR experiences. Patients undergoing head and neck surgery will be randomly allocated preoperatively to first participate in either a mindfulness or active gaming VR experience, and then postoperatively will crossover and participate in the other experience they did not utilize prior to surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing head and neck surgery
* Are able to provide informed consent

Exclusion Criteria:

* Isolation precautions
* Active eye discharge
* Active nausea or vomiting
* History of seizure, epilepsy, or hypersensitivity to flashing light
* Expected to have wounds or wound care that prevent comfortable and safe use of the VR headset
Pharmacokinetics of Antibiotics in Critically Ill Patients Receiving CVVHF

The mortality in patients with sepsis and severe acute kidney injury requiring continuous renal replacement therapy (CRRT) remains high. Antibiotic therapy is a key treatment of these patients and in recent years new antibiotics have been licensed. However, data is lacking to determine the optimal dosing regimens of these antibiotics for high (Australia and other countries) and low intensity (Japan) of CRRT.

Aim To establish the appropriate dosing regimens of newly available antibiotics during CRRT can applied globally.


Eligibility Criteria:
Inclusion Criteria:

* Adult (age ≥18 years or older)
* Sepsis (Sepsis-3 criteria)
* Acute kidney injury requiring CRRT (KDIGO criteria)
* Eligible for intensive care without restrictions or limitations

Exclusion Criteria:

* Chronic renal failure
* Obvious or suspected pregnancy
* Intracranial bleeding
Sedation MRI - Propofol Versus Propofol-Ketamin in Children

Children \< 10 years of age often need deep sedation or anaesthesia to allow elective diagnostic magnetic resonance imaging; standard routine protocols are

1. propofol induction without other sedative (Propofol much as needed) or hypnotic drugs and propofol infusion 10 mg/kg h
2. propofol induction with ketamine 1 mg /kg (little repetitive Propofol doses as needed) and propofol infusion 5 mg / kg h

both protocols are compared with regard to clinical outcome and, in cases with cerebral MRI, cerebral perfusion/blood flow.

Hypothesis:

1. reduces recovery time compared to propofol mono sedation
2. combination of ketamine-propofol increases incidence of Postoperative nausea and vomiting (PONV) compared to propofol mono sedation
3. combination of ketamine-propofol increases global cerebral blood flow and changes regional distribution of cerebral perfusion compared to propofol mono sedation


Eligibility Criteria:
Inclusion Criteria:

* MRT in deep sedation
* outpatient
* \> 3 months to \<= 10 years

Exclusion Criteria:

* tracheal intubation required
* contraindication of ketamine or propofol
* additional painful procedure requiring analgesics