cyrilzakka/clinical-trials huggingface dataset:
Decreasing the Invasiveness of Ultrasound Guided Caudal Block: A Comparison Between 22-gauge and 27-guage Needles

Ultrasound (US) has facilitated the use of caudal block in children and visualization of the needle during insertion. This prospective clinical trial study compares between two different sizes of the used needles, in terms of success rate, number of punctures, detection of the US signs (visualization of the needle, dural displacement, turbulence, and distention), and complications in pediatrics aging between 6-36 months requiring elective lower abdominal and perineal surgeries.

Ultrasound (US) has facilitated the use of caudal block in children, allowing an initial assessment of the anatomy of the sacrum, including the relationship of the sacral hiatus to the dural sac ending. Real-time US allows visualization of the needle during insertion to reach the dural sac, and to see the turbulence and distention of the layers during injection of the local anesthetic drug.

This prospective clinical trial study compares between two different sizes of the used needles, in terms of success rate, number of punctures, detection of the US signs (visualization of the needle, dural displacement, turbulence, and distention), and complications in pediatrics aging between 6-36 months requiring elective lower abdominal and perineal surgeries.

Eligibility Criteria:
Inclusion Criteria:

* Age between 6 months and 36 months
* Undergoing elective lower abdominal or perineal surgeries

Exclusion Criteria:

* Refusal of the legal guardian of the patient.
* Patients aging less than 6 months, or older than 36 months.
* Emergency surgeries.
* Coagulopathy.
* infection at the site of procedure.
* Uncorrected hypovolemia.
* Increased intracranial pressure.
* Congenital anomalies at the site of procedure.
A Study to Assess the Effects of 2 Different Prothrombin Complex Concentrates on the Pharmacodynamics of Rivaroxaban in Healthy Adult Volunteers

The purpose of this study is to assess the use of 2 different Prothrombin Complex Concentrates (PCCs) on their ability to reverse (normalize) the pharmacodynamic effects of rivaroxaban in healthy adult volunteers.

This is a single-center, open-label (volunteers and staff will know the identity of all treatments), randomized (volunteers assigned to treatment by chance) study in healthy adult volunteers to assess the effects of 2 different Prothrombin Complex Concentrates (PCCs) (drugs that act to control bleeding) on the pharmacodynamics (ie, the study of the biochemical and physiological effects of a drug on the body) of rivaroxaban (a drug that acts to prevent the formation of blood clots). Eligible volunteers will receive treatment with rivaroxaban administered orally (by mouth) on Days 1-4. On Day 5, rivaroxaban will be administered orally before the randomized intravenous (IV) (into the vein) administration of 1 of 3 treatments: Profilnine SD (a 3-factor PCC), Beriplex P/N (a 4-factor PCC), or saline. Blood samples will be collected from healthy volunteers during the study to assess the activity of rivaroxaban. Safety will be monitored throughout the study. The total length of participation in the study for each volunteer will be approximately 28 days (includes a 21-day Screening Period and a 7-day Treatment Period).

Eligibility Criteria:
Inclusion Criteria:

* Have coagulation test results of PT, INR and aPTT that are within normal limits
* Have a Body Mass Index (BMI; weight \[kg\]/height2 \[m\]2) between 18 and 30 kg/m2 (inclusive), and body weight between 50 and 100 kg
* Have blood pressure (after the volunteer is supine \[lying down with the face up\] for 5 minutes) between 90 and 140 mmHg systolic, inclusive, and between 50 and 90 mmHg diastolic
* Non-smoker

Exclusion Criteria:

* History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic (blood) disease, thrombosis, coagulation (blood clotting) disorders, lipid abnormalities, significant pulmonary (lung) disease, diabetes mellitus, renal (kidney) or hepatic (liver) insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the volunteer or that could interfere with the interpretation of the study results
* History of serious bleeding in the past, including gastrointestinal bleeding requiring hospitalization, intracranial (in the brain) bleeding of any type, or uncontrollable postoperative bleeding
* History of intracranial tumor or aneurysm or known abdominal aneurysm
* Known allergy to the study drug or any of the excipients of the formulation
* Known allergy to heparin or history of heparin-induced thrombocytopenia
Telehealth to Reduce Suicidality and Improve HIV Care Engagement in Tanzania

The overall objectives of the proposed research are to develop a brief telehealth counseling intervention to provide support for people living with HIV and experiencing suicidal ideation, and to support HIV care engagement. The investigators hypothesize that a brief telehealth counseling intervention will be safe (participants in the clinical trial will not have increased risk of suicidal behavior), acceptable (high patient retention and satisfaction, high fidelity), and will demonstrate preliminary efficacy (reduced suicidal ideation, improved care engagement, improved mental well-being).

The objective of the proposed research is to assess the feasibility and acceptability of a 3-session, nurse-delivered telehealth intervention to reduce suicidality and improve HIV care engagement among adults living with HIV in the Kilimanjaro Region of Tanzania. Suicide is a leading cause of death among people living with HIV (PLWH) worldwide and mental health disorders are key contributors to poor HIV care engagement, lower quality of life, higher transmission risk, and increased mortality among PLWH. Conversely, connecting PLWH with targeted mental health support improves these critical health outcomes. Telehealth counseling represents a cost-effective, innovative approach to mental health treatment in low-resource settings such as Tanzania, with the potential to expediently extend services. The proposed study will include Aim 1: Identifying the desired characteristics of a telehealth intervention for suicidality and HIV care engagement in the Tanzanian clinical context, Aim 2: Refining intervention content with support from a local study advisory board in Tanzania, and Aim 3: Testing the telehealth model in a pilot randomized control trial. Given emerging evidence for telehealth approaches to improve access to treatment and reduce health disparities, the intervention has great potential to support NIMH strategic objectives to address mental health comorbidities and strengthen the HIV care continuum.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Attending HIV care at study clinic
* Screen positive for suicidal ideation
* Able to understand Kiswahili or English
* Medically stable
* Capable of providing informed consent to participate

Exclusion Criteria:

* Under 18 years old
* Unable to understand Kiswahili or English
* Experiencing medical or psychiatric symptoms requiring immediate treatment
* Incapable of providing informed consent to participate
Escitalopram Plus PS128 vs. Escitalopram

The purpose of this study is to compare the efficacy and safety of escitalopram plus PS128 to escitalopram in the acute treatment of patients with major depressive disorder.

In this 6-week, double-blind, fixed-dose study, patients with major depressive disorder are randomly assigned to escitalopram (10 mg daily) plus PS128 (a psychobiotic) (300 mg two times daily, equivalent to 3 ×1010 CFU two times daily) or escitalopram (10 mg daily) groups. The rating scales and instrument, including Clinical Global Impression-Severity, 17-item Hamilton Rating Scale for Depression, Hamilton Anxiety Rating Scale, Global Assessment of Functioning, Heart Rate Variability, Depression and Somatic Symptoms Scale, Work and Social Adjustment Scale, Short form 36 and Pittsburgh Sleep Quality Index, are used to measure treatment outcomes at weeks 0, 1, 2, 3, 4, 5, and 6. UKU Side Effect Rating Scale and Gastrointestinal Symptom Rating Scale-Irritable Bowel Syndrome are used to measure side effects. Generalized estimating equations model will be used to analyze the differences between two groups with respect to efficacy and safety measures on time after adjusting for baseline severity, sex, age and age at onset of illness.

Eligibility Criteria:
Inclusion Criteria:

* Major depressive disorder
* CGI \>=4
* the score of the 17-item Hamilton Rating Scale for Depression (HAMD-17) was 18 or higher.
* washout of antipsychotics at least 3 days
* written informed consents
* Not taking fluoxetine at least one month before admission.

Exclusion Criteria:

* History of schizophrenia, schizoaffective disorder or organic mental disorders.
* comorbid with substance abuse/dependence in the past 6 months.
* with psychotic features
* treatment-resistant depression or receiving electroconvulsive therapy.
* History of serious adverse events to escitalopram
* female subjects with pregnancy or lactation.
* severe physical illness
* receiving antibiotics treatment in the past two weeks.
* taking products with probiotics.
Substudy of Protocol NCT03843957 - Effect of mPATH on Screening for Depression, Fall Risk, and Safety

This is a sub-study for data analysis of data collected as part of the larger randomized controlled trial "Effectiveness and Implementation of mPATH-CRC" (NCT03843957) to determine if self-administered screening with an iPad increases the detection of patients with depression, falls, and intimate partner violence.

As part of the parent study (NCT0343957), investigators developed an iPad program called mPATH that patients use at their primary care clinician's office to encourage colorectal cancer screening. To encourage practices to use mPATH with every patient, the investigators included in the program the health system's required screening items for depression, fall risk, and intimate partner violence, thereby offloading this routine task from clinical staff. It is possible that mPATH will increase detection of depression, fall risk, and intimate partner violence because: 1) mPATH systematically asks these screening items of all patients, and 2) patients may feel more comfortable answering these items on an iPad survey than during an in-person interview.

To determine the effect of mPATH on the performance of this screening, investigators will examine a limited use dataset comparing the 2 months before a clinic started using mPATH to the 2 months after the clinic began using mPATH. Because clinics may need some time to fully adopt mPATH, investigators will exclude the first two weeks following the launch of mPATH.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Completed a provider visit at the study clinic during the 60 days prior to the clinic launching the mPATH program (the "pre" time period), or completed a provider visit at the study clinic during days 14 - 73 after the launch of mPATH (the "post" time period)
* Have a preferred language of English or Spanish

Exclusion Criteria:

• Requiring a language interpreter for a language other than Spanish
Pilot Study of 18F-FLT PET

Fractionated radiotherapy induces an observable change in the proliferative activity as assessed by pre-treatment and early-treatment 18F-FLT PET imaging. This study is designed to investigate 18F-FLT as a PET imaging agent for predicting treatment effectiveness in several tumors and will serve as a pilot study to a planned PO1 submission


Eligibility Criteria:
Inclusion Criteria:

* Able to tolerate a PET/CT scan
* Age of 18 or older
* signed informed consent
* being considered for radiotherapy for treatment of CNS mets, Head and neck cancer, lung cancer, prostate cancer or esophageal cancer

Exclusion Criteria:

* Prior XRT to site being studied
* severe claustrophobia or inability to tolerate PET/CT
* unable to provide written consent
* pregnant or breastfeeding women
Can Virtual Reality Technology Improve the Patient Experience in Oocyte Retrieval?

A non-pharmacological, non-blinded, randomized cohort study that will investigate the effect of Virtual Reality technology on the patient experience during oocyte retrieval.

The primary objective of the trial is to investigate the impact of Virtual Reality technology on the patient experience


Eligibility Criteria:
Inclusion Criteria:

* Women undergoing oocyte retrieval
* Understanding and speaking Danish

Exclusion Criteria:

* Previous participation in the trial
* Acupuncture as pain relief during oocyte retrieval
Study of the Effect of Rifampicin on the Pharmacokinetics (PK) of Multiple Doses of Cediranib in Patients With Solid Tumours

Phase I, open study to assess the effect of rifampicin, a marketed drug, on how the body handles the experimental drug cediranib in patients with advanced cancer.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Prostate cancer), which is refractory to standard therapies or for which no standard therapy exists.
* Estimated life expectancy of at least 8 weeks
* WHO performance status (PS) 0-2.

Exclusion Criteria:

* Unstable brain/meningeal metastases
* Biochemistry/haematology results outside of required ranges
* History of significant GI impairment
* Inadequate bone marrow reserve
Dual-process Mechanisms of Action for sipIT Intervention Effects in Patients With Urolithiasis

The purpose of this study is to clarify the fundamental processes underlying behavior change, maintenance, and adherence during and after a 3-month fluid intake intervention period.

The study is a six-month ecological momentary assessment study of patients using the mini-sipIT intervention for 3 months, with weekly assessments of motivation and life events or stressors that disrupt routines during the 3-month intervention period, and monthly assessments of motivation and life events or stressors that disrupt routines in the three months following the end of intervention (months 4-6). The mini-sipIT intervention includes automated and manual tracking of fluid intake and lapse-contingent reminders to drink.

Eligibility Criteria:
Inclusion Criteria:

* Previous diagnosis of symptomatic kidney stone in the past 5 years,
* Age 18 or older,
* Own an iOS or Android smart phone,
* Proficient in English,
* Capable of providing informed consent,
* Willing to use the water bottle and companion app \& receive text message reminders for 3 months,
* Live in continental US.

Exclusion Criteria:

* Pregnant or planning to become pregnant during the next 6 months,
* Concurrently participating in other study involving fluid intake or diet,
* Plan to have surgery in the next 6 months,
* Co-morbidities that preclude high fluid intake (congestive heart failure, end-stage renal disease, chronic hyponatremia), or
* Active medical treatments that would impair protocol compliance.
Anti-Obesity Effect of Pediococcus Pentosaceus LP28

This study is designed to evaluate efficacy of Pediococcus pentosaceus LP28 in reducing body fat and body weight in subjects with BMI 25-30 kg/m2.


Eligibility Criteria:
Inclusion Criteria:

* BMI 25-30 kg/m2

Exclusion Criteria:

* Taking medicines or functional food that may affect body weight or body fat
* Pregnant or nursing a child
* Participation in any clinical trial within 90 days of the commencement of the trial
* Renal or hepatic dysfunction
* Heart disease
Fetal Vascular Hemodynamic Changes in Iron Deficiency Anemia

Iron deficiency anemia is a worldwide medical disorder. So far, it is the most common medical complication in pregnancy specially in developing countries. It is the cause of many adverse effects on mother and fetus and contributes significantly to high maternal mortality. Maternal iron deficiency anemia is frequently associated with premature delivery, low birth weight babies


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women with gestational age 28-32 weeks
* singleton pregnancy
* iron deficiency anemia.

Exclusion Criteria:

* Multiple pregnancy
* antepartum hemorrhage
* major congenital fetal anomalies
* any other type of anemia other than iron deficiency anemia
* any acute or chronic maternal disease other than iron deficiency anemia.
Information About a Doctor or a Possibility of Choosing Doctor's Gender and Attendance to Screening Colonoscopy

The purpose of the study is to investigate whether the information about a doctor or possibility to choose doctor's gender included in invitation letter is associated with attendance rate to screening colonoscopy.

Study is performed as a part of NordICC (Clinical trials NCT 00883792) trial, which is intended to investigate the effect of screening colonoscopy on colorectal cancer incidence and mortality. NordICC trial is a multicenter, randomized study conducted in Norway, Sweden, Netherlands and Poland.

This study is designed to assess two factors potentially influencing patients attendance. These two factors are: identification of particular doctor performing examination and the possibility of choosing doctor's gender.

Eligibility Criteria:
Inclusion Criteria:

* Individuals 55-64 years of age randomized to the screening arm of the NordICC trial in Poland

Exclusion Criteria:

* previous open colorectal surgery
* need for long term attention and nursing services (somatic or psychosocial reasons, mental retardation)
* ongoing cytotoxic treatment or radiotherapy for malignant disease
* severe chronic cardiac or pulmonary disease (NYHA III and IV)
* lifelong anticoagulant treatment
* coronary or cerebrovascular incident requiring hospitalization during the last three months
* residence abroad
* return of unopened letter of invitation and/or reminder, or message of death of the subject (not updated in Population Registry)
* failure to provide written informed consent
* screening colonoscopy within 10 years
Robotic Versus Laparoscopic Liver Resection for Hepatocellular Carcinoma

The objective of the study is to investigate the long-term outcomes of minimally invasive liver surgery (robotic vs laparoscopic) for hepatocellular carcinoma patients of stage BCLC 0-A. Data from two tertiary centers for liver surgery will be retrospectively reviewed. Patients will be divided in two cohorts (robot; laparoscopy). The primary endpoint will be recurrence-free and overall survival; secondary endpoints were incidence, pattern, and treatment of recurrences.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing robotic and laparoscopic resections
* Histology-confirmed HCC of stage BCLC 0-A
* Preserved liver function (Child score A-B)
* Patients \>18 years old

Exclusion Criteria:

* Hand-assisted procedures
* Non-elective surgery
* Intraoperative switch to locoregional therapies (like radiofrequency or microwave ablation)
* Non-histologically confirmed HCC
* Mixed hepato-cholangiocarcinoma.
Impact of Smoking and Nicotine on the Risk of Being Infected With COVID-19

Several studies have shown that smokers have a higher risk of developing a severe form of COVID-19 once a person has been infected. This is explained by the damage caused by smoking at the bronchopulmonary level and an overexpression of some coronavirus receptors at the pulmonary level when exposed to tobacco. In contrast, recent data indicate that smokers are proportionally less infected with the COVID-19 virus since all available cohort data from around the world show a very low rate of smokers among COVID-19 infected subjects. The mechanisms at the origin of this protective effect are not known. All of these data lead us to question the real role of nicotine in the protective effect of tobacco observed in the general population against infection by the COVID-19 virus.

The objectives are :

* To show that subjects taking nicotine substitutes as part of a smoking cessation program are less infected with COVID-19 than non-smokers.
* To show that active smokers are less infected with COVID-19 than non-smokers.
* To compare the percentage of positive serological tests in subjects taking nicotine substitutes to the percentage of positive serological tests in active smokers.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old
* Subject who will require a serological test for COVID-19 virus as part of standard of care.
* Group 1: Active smoker since October 2019
* Group 2: Smoker undergoing smoking cessation and taking nicotine substitutes on a regular basis since October 2019
* Group 3: Non-smoker

Exclusion Criteria:

* Inpatient subject
* Subjects with a chronic serious pathology modifying the risk of exposure to COVID-19
InterStim® Amplitude Study

This feasibility study will explore the effects of three different InterStim amplitude settings on overactive bladder symptoms (OAB).

This is a prospective, randomized, multicenter, single-blinded study to explore the efficacy and quality of life (QoL) of 3 different amplitude settings.

Eligibility Criteria:
Inclusion Criteria:

1. Primary diagnosis of urinary urge incontinence (UUI) as demonstrated on a 3-day baseline voiding diary demonstrating at least 3 UUI episodes
2. Female subjects 18 years of age or older
3. Candidate for InterStim Lead Placement
4. Willing and able to accurately complete voiding diaries, questionnaires, attend visits, and comply with the study protocol (which includes maintenance of InterStim II programming settings over the course of the study)
5. Willing and able to provide signed and dated informed consent
6. Willing to maintain current regimen (dosage and frequency) of any overactive bladder (OAB) medication

Exclusion Criteria:

1. Have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury
2. History of diabetes unless the diabetes is well-controlled through diet and/or medications
3. Symptomatic urinary tract infection (UTI)
4. Have primary stress incontinence or mixed incontinence where the stress component overrides the urge component
5. Treatment of urinary symptoms with botulinum toxin in the past 9 months or any plan to have botulinum toxin treatment during the study
6. Implanted with a neurostimulator, pacemaker, or defibrillator
7. Have knowledge of planned MRIs, diathermy, microwave exposure, high output ultrasonic exposure, or radio frequency (RF) energy exposure not included within the scanning conditions provided with the MRI Guidelines for InterStim Therapy
8. Women who are pregnant or planning to become pregnant
9. Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements.
10. Currently enrolled or planning to enroll in a potentially confounding clinical study during the course of the study (co-enrollment in concurrent studies is only allowed when documented pre-approval is obtained from the Medtronic study manager (or designee).