cyrilzakka/clinical-trials huggingface dataset:
Pharmacokinetics and Pharmacodynamics of Levobupivacaine During Continuous Caudal Epidural Analgesia in Newborns

The goal of this clinical trial is to learn about the pharmacokinetics of levobupivacaine in newborns during the continus caudal epidural analgesia. This type of analgesia is used for severly ill newborns. There is a need to lower the opioid doses for this population who is undergoing the surgery due to the life threading indication. In some cases it is considered to use the epidural analgesia for the sake of the patient.

The main question is:

Is the commonly used dosing of 0,25% levobupivacaine in dose 0,2-0,3mg/kg/h the ideal dosing for these patients?

Is this type of dosing of epidural analgesia safe and effective for newborns?


Eligibility Criteria:
Inclusion Criteria:

* Obtained informed consent of parent(s)/legal representative(s)
* Age younger than 45thweek of PMA
* Age older than 25thweek of PMA
* body weight (BW) more than 500g
* Previous or planned operation with great demand on POPM
* Other diseases demanding great POPM (even without any need of surgery)
* Vital functions of the patient will be stable and there will be no suspicion, that patient current condition might be worsen by insertion of c-CELA (every patient will be discussed with attending physician )

Exclusion Criteria:

* Decline of informed consent by parent(s) legal representative
* Age older than 45thweek of PMA
* Age younger than 25th week of PMA
* body weight (BW) lower than 500g
* Congenital malformation of caudal part of spine ( spina bifida occulta , meningocele, meningomyelocele)
* Disease or congenital malformation significantly restricting liver functions (Elevation of liver enzymes more than twice above the physiological range of the corresponding PMA)
* Disease or congenital malformation significantly restricting kidney functions (Elevation of urea and creatinine enzymes more than twice above the physiological range of the corresponding PMA)
* Clinical condition, which doesn't long-term POPM
* Meningism
* Patients with proven withdrawal syndrome caused by opiate administration
* High risk of bleeding during insertion (coagulopathy) or known administrated anticoagulants which might be still active in the time of insertion of c-CELA
* Substantial anemia (under 90g/l), which could lead to blood transfusion due to blood drawing
* frequent blood tests associated with the treatment of the patient(with blood samples necessary for the purposes of the study together), which would exceed maximum
* any hemodynamically unstable condition (for example septic shock)
Department of Defense PTSD Adaptive Platform Trial - Intervention A - Fluoxetine

This is a Phase 2 randomized, double-blinded, placebo-controlled study that will evaluate multiple potential pharmacotherapeutic interventions for PTSD utilizing an adaptive platform trial design.

Intervention A - Fluoxetine will assess the safety and efficacy of fluoxetine in participants with PTSD.

Please see NCT05422612 for information on the S-21-02 Master Protocol.

The general structure of this Adaptive Platform Trial (APT) consists of a 30-day Screening Period, a 12-week Platform Treatment Period, and a 4-week Safety Follow-up. The S-21-02 Platform Trial will evaluate the safety and efficacy of multiple investigational products for the treatment of PTSD (see NCT05422612 for Master Protocol information). Participants are randomized among the multiple cohorts in the study and the resulting randomization enables sharing/pooling of control subjects, where all interventions may be compared to a common control (placebo). This record only includes information relevant to the fluoxetine cohort.

Once a participant meets all eligibility criteria for the Master Protocol, eligibility for each currently enrolling intervention cohort is assessed. Eligible participants will be randomized with equal probability into a cohort. Participants randomized to the fluoxetine cohort are then randomly assigned to receive either fluoxetine or placebo (in a ratio of 5:3; intervention:placebo), for the duration of the 12-week treatment period.

Parties interested in having their intervention considered for testing within the M-PACT should complete a request for information form using this webpage https://citeline.qualtrics.com/jfe/form/SV_8eTQKw6TNug4z42..

Eligibility Criteria:
Inclusion Criteria:

No additional inclusion criteria beyond the inclusion criteria specified in the Master Protocol (NCT05422612).

Exclusion Criteria:

The following exclusion criteria are in addition to the exclusion criteria specified in the Master Protocol (NCT05422612).

1. Recent history of treatment for PTSD with fluoxetine at doses of 20 mg daily, for at least 4 weeks. A remote history of treatment with fluoxetine for non-PTSD symptoms will be discussed on a case-by-case basis with the contract research organization (CRO) Medical Monitor.
Nasal Versus Buccal Oxygen Administration for Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration

The purpose of this study is to compare to nasal and buccal oxygen administration in patients undergoing Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration .

Anesthesia for Endobronchial Ultrasound (EBUS) may be range from routine bronchoscopy sedation to general anesthesia. During sedation to EBUS increased duration of anesthesia and sedative dosing put patients at increased risk for hypoxic events. To avoid this, oxygen supplementation is mandatory. There are different techniques for oxygen supplementation during the procedure. At this study we will compare to nasal and buccal oxygen supplementations during EBUS.

Eligibility Criteria:
Inclusion Criteria:

* patients ≥18 years of age
* body mass index (BMI) between 20 and 30
* American Society of Anesthesiologists physical status I-III

Exclusion Criteria:

* congestive heart failure
* ischemic heart disease
* increased intracranial pressure
* known allergy or contraindication to study drugs (propofol, fentanyl, or midazolam)
* an anatomical feature precluding adequate positioning of the buccal device.
Testing Two Different Intensities of an Intervention to Enhance REsilience and to Reduce SupportIve Care Needs in Cancer Patients

The aim of this phase II study is to test by feasibility and efficacy of two interprofessional supportive care interventions with different intensities to facilitate resilience in patients and thereby to reduce their unmet supportive care needs.

Intervention A (tested in arm A) includes screening of resilience and supportive care needs as well as direct feed-back of the screening results on a monitoring sheet to nurses and oncologists in charge of the patient. Nurses and oncologists follow three training sessions to be trained in a) resilience facilitation, b) interventions to adress supportive care needs, c) use of the monitoring sheet.

Intervention B (tested in arm B) includes same intervention as arm A supplemented by 5 structured nurse led consultations, two face to face (F2F), three by phone (PC) provided by clinical nurse specialists and based on a consultation manual.

Eligibility Criteria:
Inclusion Criteria:

* age 18 years and older
* attending the clinic for the first chemotherapy administration
* newly diagnosed (between 4-15 weeks after diagnosis) with a new carcinoma / lymphoma
* sufficiently literate in French or German to complete questionnaires.

Exclusion Criteria:

* recurrent disease
* being treated in in-patient or palliative care units
* diagnosed with all other cancers
* in need of complex chemotherapy
* being judged by the oncologist as not being emotionally or physically capable to participate in the trial will be excluded.
A Trial of Norethisterone Acetate and Expectant Management in Treatment of Simple Ovarian Cysts

To compare the effectiveness of (norethisterone acetate) in the treatment of spontaneously occurring simple ovarian cyst detected by ultrasonography compared with expectant management.

An ovarian cyst is a sac filled with liquid or semiliquid material that arises in an ovary. The number of diagnoses of ovarian cysts has increased with the widespread implementation of regular physical examinations and ultrasonographic technology.

The discovery of an ovarian cyst causes considerable anxiety in women who fears of malignancy, but the majority of ovarian cysts are benign.

These cysts can develop in females at any stage of life, from the neonatal period to postmenopause. Most ovarian cysts, occur during adolescence, which are hormonally active periods of development.

Most are functional in nature and some times resolve without treatment. However, ovarian cysts can herald an underlying malignant process or, possibly, distract the clinician from a more dangerous condition, such as ectopic pregnancy, ovarian torsion, or appendicitis.

When ovarian cysts are large, persistent, painful, or have concerning radiographic or exam findings, surgery may be required, sometimes resulting in removal of the ovary. If a cyst does not resolve after several menstrual cycles, it is unlikely to be a functional cyst, and further workup is indicated.

Early epidemiological studies reported an inverse relationship between use of oral contraceptives (OCs) and surgically confirmed functional cysts . Many previous studies have indicated that the use of Oral Contraceptive pills (OC) is associated with a lower risk of occurrence of functional ovarian cysts. few studies have considered the treatment effect of OC on functional ovarian cysts. In current clinical practice, gynecologists treat functional ovarian cysts with either OC or expectant management alone. Several randomized controlled trials have shown no significant difference in the resolution of functional ovarian cysts treated with OC over expectant management alone Functional ovarian cyst can occur due to estrogen hyperstimulaton and some theories conceoted that progesterone treatment can suppress this cyst .

Eligibility Criteria:
Inclusion Criteria:

1. women at age 24-49 years old
2. women with simple cyst.( with none of the following: solid parts, papillary formations, peritoneal masses, intraabdominal lymph node enlargement or ascites ) .(13)
3. from 5 to10cm in diameter.
4. functioning cyst.( defined as largest dimension between 2-8 cm in diameter, unilateral, uniloculated, thin-walled, anechogenic and has distal acoustic enhancement )

Exclusion Criteria:

1. premenarche
2. postmenopause
3. current user of Norethisterone acetate.
4. those having contraindication from Norethisterone use.
5. gynecologic malignancy
Simvastatin (Zocor) Therapy in Sickle Cell Disease

Recent clinical and experimental data indicate that statins have effects beyond cholesterol lowering that may be beneficial in sickle cell disease by protecting the vascular endothelium. Statins have been shown to attenuate endothelial dysfunction through their anti-inflammatory, anti-oxidant and anti-thrombotic properties. This phase I/II dose-escalating trial is designed to assess the safety and potential clinical efficacy of oral simvastatin (Zocor)in adolescents and adults with sickle cell disease (SCD).

Although statins have been used extensively for their cholesterol-lowering effects, recent clinical and experimental data indicate that statins regulate yet other processes, many of which play a major role in sickle cell disease (SCD). Independent of their cholesterol-lowering effects, statins have been shown to prevent damage to blood vessels in several ways, through upregulation of endothelial nitric oxide (NO)and decreased inflammation. Numerous studies documenting the protective effects of statins, together with data showing the therapeutic role of NO in SCD, provide the basis for investigating the potential clinical benefit of simvastatin in SCD.

Data supporting the safety and tolerability of simvastatin in patients with SCD are now needed. For this phase I/II dose-escalation study of oral simvastatin in SCD, we propose the following specific aims:

1. To obtain preliminary efficacy data on the effects of oral simvastatin on plasma biomarkers of endothelial injury in patients with SCD, and
2. To assess the safety and tolerability of oral simvastatin in patients with SCD.

Eligibility Criteria:
Inclusion Criteria:

* Established diagnosis of sickle cell disease (HbSS, SC or Sβ-thalassemia)
* Age greater than or equal to thirteen years
* Weight greater than or equal to 35 kg

Exclusion Criteria:

* Renal dysfunction (Serum Creatinine \> 1.5 UNL)
* Hepatic dysfunction (ALT \> 2X UNL)
* Pretreatment total cholesterol \< 100 mg/dL or triglycerides \< 30 mg/dL
* Pretreatment baseline creatine kinase \>1X UNL (215 U/L)
* Pregnancy/lactation
* RBC transfusion in the last 30 days
* Vaso-Occlusive Event needing hospitalization in the past 30 days
* Treatment with any statin drugs within the past 30 days
* Treatment with drugs having known metabolic interactions with statin drugs (e.g. cytochrome P450 3A4 metabolism), including ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, azithromycin, niacin (nicotinic acid), digoxin, coumadin, sildenafil or amiodarone within the past 30 days
* Treatment (past or present) with amiodarone
* Musculoskeletal disorder associated with an elevated creatine kinase level
* Past or present history of substance abuse (alcohol, cocaine, amphetamines, heroin, PCP)
* Allergy to statins
Spanish BMT4me Usability & Acceptability

The objective of this project is to trans-create, conduct user testing of a previously developed and piloted mHealth app, and user acceptability with parents of children in the acute phase post-allogeneic hematopoietic stem cell transplant (HSCT). Nationwide Children's Hospital (NCH) will be the primary data collection site and Columbia University Irving Medical Center will be a secondary site.


Eligibility Criteria:
Inclusion Criteria:

Eligible caregivers must have children who:

1. Are 0-17 years old
2. Underwent HCT
3. Are planned for discharge prior to day 100 post-transplant

Primary caregivers must:

1. Be Spanish speaking
2. Be ≥18 years old
3. Have a smartphone (iOS or Android) capable of downloading apps

Exclusion Criteria:

(a) Children or caregivers with pre-existing neurodevelopmental disorder/disability or a pervasive developmental disorder will be excluded from this study.
Effect of Cerebral Oxygen Saturation Intervention

Postoperative delirium (POD) is a common complication after cardiac surgery,and the pathogenesis is considered imbalance of cerebral oxygen. It may induce the POD incidence by monitering and intervening the low cerebral oxygen desaturation(SCO2) in cardiac surgery .Near infrared spectroscopy (NIRS) will be used for monitering the cerebral oxygen levels.140 case will be included and divided in to trial and control group. The primary outcome is POD In 72 hours after the surgery , which is assessed according to delirium scale .

Postoperative delirium (POD) is a common complication after cardiac surgery. Imbalance of cerebral oxygen supply and demand is one of the pathogenesis of postoperative delirium. The perioperative cerebral oxygen levels and postoperative delirium highly correlated, while as a high incidence of cerebral oxygen desaturation(SCO2) in cardiac surgery, especially in extracorporeal circulation. Near infrared spectroscopy (NIRS) can monitor the SCO2 continuously, noninvasively, simultaneously on bilateral cerebral hemisphere, and monitoring will not restricted by extracorporeal circulation.Using NIRS to moniter and intervene thecerebral oxygen levels in extracorporeal circulation of heart surgery patients ,thereby reducing the incidence of postoperative delirium. This hypothesis has a very important clinical value.

This study intends to include 140 patients, who requires extracorporeal circulation cardiac surgical treatment. All cases will be divided into trial group and control group preoperative follow-up.Two groups of patients in surgery will be both performed the investigator's existing standerd monitoring and surgery process.

The trial group cases will be given NIRS monitoring in the whole surgical procedure. And once the SCO2 value below ideal levels (80% of the basic level or 50% of the absolute value), the intervention process will be started immediately to correct the low cerebral oxygen status, by adjusting the position of extracorporeal circulation arteriovenous catheter, stabilizing the mean arterial pressure, increasing oxygen supply and , adjusting the pump speed, etc. The control group cases will be only placed the probe of NIRS moniter.

In 72 hours after the surgery , all patients will be assessed POD by cardiac surgery intensivecare unit(CICU) physicians according to delirium scale .

This project intends to research monitoring brain oxygen supply and intervention can reduce the incidence of postoperative delirium.

Eligibility Criteria:
Inclusion Criteria:

1. Participate and sign the informed consent voluntary;
2. Over 18 years of age;
3. Who recieve the heart surgery under extracorporeal circulation;
4. Able to communicate and abey the experimental requirements well .

Exclusion Criteria:

1. Refused to sign a consent form;
2. Less than 18 years of age;
3. With history of nervous, mental, and cerebrovascular disease;
4. With history of alcohol or apsychiatric drug addiction;
5. Can't cooperate the evaluation: dementia, dysaudia, visually impaired , etc;
6. Critically diseases: severe liver and kidney dysfunction, cardiac shock or IABP placement status.
Task-Oriented Occupational Therapy Approach in Chronic Stroke: Performance, Balance, Quality of Life

Chronic stroke is a neurological disorder that leads to long-term disability and functional impairments in motor, sensory, cognitive, and speech functions, persisting beyond six months after the stroke incident. The purpose of this study was to investigate the effects of task- oriented occupational therapy intervention on occupational performance, occupational balance, and quality of life in individuals with chronic stroke. The study included 30 individuals with chronic stroke aged between 18 and 65, who were divided into two groups:

the task-oriented occupational therapy intervention group (TOOT) (n=15) and the control group (n=15). The participants in the TOOT group received task-oriented occupational therapy intervention in 30-minute sessions, five days a week, for four weeks, while the control group received routine upper-extremity-based occupational therapy intervention in a hospital setting.


Eligibility Criteria:
Inclusion Criteria:

* aged 18-65 years old,
* completed the acute phase of stroke
* experienced ischemic and/or hemorrhagic stroke
* had \<=21 scores of Montreal Cognitive Assessment (MoCA)
* had \<= 15 scores of the Rivermead Motor Assessment (RMA)
* had a motor stage of the hand and upper extremity motor stage level 3 or higher of the Brunnstrom Stages of Motor Recovery
* had scoring 2 or lower on the Modified Ashworth Scale for muscle tone around the shoulder, elbow, and wrist were included into the study.

Exclusion Criteria:

* Had an orthopedic problem affecting the upper extremity
* had undergone surgery in the past 6 months
* had a diagnosis related to a psychotic disorder.
Effectiveness of TheraNeem Lip Therapy for Herpes Simplex Labialis

This study intends to test the efficacy of the TheraNeem Lip Therapy balm for Herpes Simplex. The study will include a total of 5 people.

Qualified candidates will be officially enrolled into the study within 24 hours of their subsequent outbreak of Herpes Simplex Labialis. They will be given all of the Neem Therapy products to use, and photographs and questionnaires will be taken to assess their progress.

Eligibility Criteria:
Inclusion Criteria:

1. Participant has signs and symptoms of HSV-1 infection of less than 24 hours duration to the Southern California University of Health Sciences investigators
2. Participants ages 18-70 years
3. Confirmation of oral-circumoral herpes lesion will be made by a clinician in the presence of oral-circumoral lesion assumed to be HSV-1 for purposes of study
4. Subjects expressed willingness to comply with protocol
5. Subject will be willing to have the presenting lesion photographed twice
6. Subject sign a written informed consent, HIPPA disclosure, Experimental bill of rights

Exclusion Criteria:

1. History of past or present immunosuppressive condition, or currently taking immunosuppressive medication
2. History of adverse effects or allergies to any Neem based product or containing any of the other ingredients TheraNeem Lip Therapy: Organic Coconut Oil, Organic Beeswax, Organic Jojoba Oil, Shea Butter, Sesame Oil, Organic Neem Oil, , Essential Oil of Peppermint, Vitamin E (Tocopherol)
3. Signs of disseminated HSV illness
4. History of use of oral or topical antiviral agents within 10 days of screening and/or at start of study visit
5. Pregnancy or lactation
6. Psychiatric disorder
7. Inability to understand or follow the instructions
Study to Assess the Effect of Co-Administration of AZD9833 on the Pharmacokinetics of Midazolam, of Omeprazole, of Celecoxib and of Dabigatran Etexilate in Healthy Postmenopausal Female Volunteers

This study will be a fixed sequence drug-drug interaction study in healthy postmenopausal females, conducted at multiple study sites

Participants will be randomized to one of 3 treatment arms on Day 1 prior to Investigational Medicinal Product (IMP) administration:

* Arm A: single oral doses of midazolam and omeprazole administered together + repeated doses of AZD9833 .
* Arm B: single oral doses of dabigatran etexilate + single oral dose of AZD9833 .
* Arm C: single oral doses of celecoxib + repeated oral doses of AZD9833.

Each participant will be involved in the study for up to 7 to 8 weeks

Eligibility Criteria:
Inclusion Criteria:

* Healthy postmenopausal female participants aged 50 to 70 years with suitable veins for cannulation or repeated venipuncture.
* Participants must be postmenopausal by fulfilling the following criterion:
* Have a Body mass index (BMI) between 19 and 35 kg/m\^2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive as measured at screening.
* Must agree to not use warfarin or phenytoin (and other coumarin-derived vitamin K antagonist anticoagulants) during study, and for 2 weeks after last administration of IMP.

Exclusion Criteria:

* History of any clinically significant disease or disorder as described by the Investigator.
* History or presence of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
* Use of systemic estrogen-containing hormone replacement therapy within 6 months prior to first dose in the study.
* Have taken any proton pump inhibitors (omeprazole, lansoprazole, esomeprazole, pantoprazole, etc.) within 14 days of beginning study treatment (ie, first administration of omeprazole in Arm A.
* Have taken any drug with enzyme-inducing properties such as St John's Wort within 3 weeks of screening.
* Presence of any contraindication to the probe substrates omeprazole, midazolam, dabigatran or celecoxib per the United States Package Insert.
* Any of the following signs or confirmation of COVID-19 infection:
* Subject has a positive RT-PCR test for SARS-CoV-2 prior to randomization.
* Clinical signs and symptoms consistent with COVID-19 (eg, fever, dry cough, dyspnea, sore throat, fatigue) or confirmed infection by appropriate laboratory test within the last 4 weeks prior to screening or at randomization.
* Subject has been previously hospitalized with COVID-19 infection within the last 12 months.