cyrilzakka/clinical-trials huggingface dataset:
Analgesic Efficacy of Rhomboid Intercostal Nerve Block for Minimal Invasive Heart Surgery

The goal of this clinical trial is to test the analgesic efficacy of rhomboid intercostal nerve block (RINB) in patients undergoing minimal invasive heart surgery (MIHS). The main questions it aims to answer are:

* How will the total perioperative opioid consumption of the patients receiving RINB change?
* How will RINB effect the patients' numeric rating scores for pain in the postoperative 24-hour period?
* How will RINB effect the postoperative extubation times?
* How will RINB effect the length of intensive care unit (ICU) stays on the postoperative period?
* How will RINB effect the incidence of opioid related side effects?

Participants will be divided in two groups:

* Block group will receive a RINB before the surgery.
* Control group will not receive any nerve block. Researchers will compare the results between the groups to see the postoperative effects concerning opioid consumption as well as the pain scores, respiratory parameters and ICU length of stay of the patients receiving RINB for minimal invasive heart surgery.

The hypothesis of this study is that participants receiving RINB for MIHS will have a less total opioid consumption 24 hours postoperatively.

Rhomboid intercostal nerve block (RINB) was first defined by Elsharkawy et al in 2016 proposing to provide analgesia for both the anterior and posterior hemithorax. Minimal invasive heart surgeries require a surgical incision of the lateral thoracic wall. In order to ease the postoperative pain of patients undergoing MIHS, some regional anaesthesia techniques have been tried but there is no consensus on the best method. This study aims to assess the analgesic efficacy of RINB for MIHS. The hypothesis is that participants receiving RINB for MIHS will have a less total opioid consumption 24 hours postoperatively. Also, the postoperative pain scores, respiratory parameters and ICU length of stay of the participants will be recorded. Participants will be divided in two groups. The block-group will receive a RINB preoperatively in the operating room. The control-group will not receive any nerve block. The participants will be followed 24 hours postoperatively and their total opioid consumption, numeric rating scores for pain, postoperative extubation times, length of ICU stays, incidence of opioid related side effects will be recorded. Also the participants and the surgical teams perioperative pain related satisfaction will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Patients between the age of 18-80 undergoing minimal invasive heart surgery

Exclusion Criteria:

* Allergy to local anaesthetics
* Chronic opioid use history
* Patients with psychiatric disorders
* Patients who are not open to communication
* Patients with chronic organ failure
* Patients that do not give consent
* Patients that need emergency surgery within the first 24 hours of the initial surgery
Split Dose Golytely With Amitiza Pretreatment Versus Split Dose Golytely Plus Placebo in Outpatient Colonoscopy

The primary outcomes of this procedure will be: 1. The cleanliness of the prep as measured by the Ottawa Scale (attachment a). Secondary outcomes will be: 1. Patient satisfaction with the prep measured by 5 point Likert scale (attachment b); 2. Procedure time; 3. The number and size of polyps detected on examination.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients referred to our clinic for Average or Increased Risk screening for Colorectal Cancer
* Ages will be from 18 years of age and older

Exclusion Criteria:

* Chronic kidney disease
* Previous diagnosis of congestive heart failure
* History of bowel obstruction
* History of solid organ transplant
* Pregnancy
The Link Between Mental Imagery and the Reduction of Fear in Imaginal Extinction

Imaginal exposure is a widely used psychological treatment technique. Imaginal extinction is an experimental analogue of imaginal exposure, that allows the study of this treatment technique under controlled circumstances (Agren, Björkstrand, \& Fredrikson, 2017). During imaginal extinction, experimentally induced fear is diminished through repeated exposure to mental imagery of the feared (conditioned) stimulus. However, it is not known to what extent fear reduction depends on the mental imagery produced during this procedure. A better understanding of the mechanisms driving the effects of imaginal exposure and the factors moderating fear reduction could have significant clinical utility, by suggesting mechanistically informed ways to improve this treatment.

The study takes part over three consecutive days, with fear conditioning to visual stimuli on day 1, imaginal extinction on day 2, and a fear reinstatement procedure, again to visual stimuli, on day 3. Skin conductance is used to measure fear responses.

Participants' are randomized to receive conditioning, extinction and reinstatement with either complex or simple stimuli. During imaginal extinction, imagery of each experimental stimulus is prompted through different verbal instructions.

Eligibility Criteria:
Inclusion Criteria:

Age 18 or over

Fluent in Swedish

Willing and able to provide informed consent and complete study procedures

Exclusion Criteria:

Current psychiatric disorder

Use of psychotropic medication within 6 months prior to study start

Receiving psychological treatment within 6 months prior to study start

Current neurological condition
Bone Health in Patients With Atopic Dermatitis

This study examines the bone health in children with atopic dermatitis

The goal of this study is to objectively evaluate bone health and contributing factors in children with AD. This will be compared with existing normative data. Such an objective prospective study, directly looking at bone health in children has not yet been done. This will be done using bone densitometry (DXA) and high-resolution peripheral quantitative computed tomography (HR-pQCT) for the accurate and precise measurement of bone health status. HR-pQCT is a cutting-edge technology available at only at a few academic centers in the United States that is used to measure bone strength with minimal doses of radiation. In addition, blood and urine metabolic parameters related to bone health will be analyzed, and data will be correlated with eczema severity. The results from this study will allow us to design large-scale, multi-institutional studies on bone health in this population and ultimately to guide decision making in children who may be at risk specifically regarding treatment recommendations and supportive care.

The specific aims of this project are:

1. To determine bone mineral density (BMD) and cortical and trabecular bone strength in children with atopic dermatitis, using DXA and to compare this with normative data.
2. HR-pQCT data will be compared with current known data from other diseases
3. To correlate bone mineral density with eczema severity using Eczema area and severity index (EASI) and Scoring atopic dermatitis (SCORAD) scores.
4. To determine if bone mineral density in children with atopic dermatitis correlates with bone age and bone-health specific serum markers.

Eligibility Criteria:
Inclusion Criteria:

* Children 5 to 17 years of age with a diagnosis of moderate to severe atopic dermatitis as made by a dermatologist
* Duration of atopic dermatitis symptoms for a minimum of 6 months
* Ability to cooperate with DXA and HR-pQCT procedure

Exclusion Criteria:

* Those without a confirmed diagnosis of moderate to severe atopic dermatitis
* Presence of concurrent disease that may also affect bone health, including rickets or other vitamin D deficiency, thyroid disease, renal disease, Paget's disease, osteogenesis imperfecta, inflammatory bowel disease, and other chronic inflammatory diseases
* Current use of medications that may affect bone health, including bisphosphonate, Forteo, Tymlos, denosumab, thiazide, heparin, medroxyprogesterone acetate, cyclosporine, and oral tacrolimus. However, medications that are used for atopic dermatitis treatment are allowed
* Pregnant or breast feeding females
* Inability to cooperate with the blood draw
Can Cesarean Scar Defects be Prevented?

In this study, uterotomy after cesarean section was performed using 3 different suture techniques and aimed to demonstrate the potential of the baseball suture technique to prevent the isthmusel complication known as cesarean scar defect.

An isthmocoele or cesarean scar defect is a pit-like defect in the myometrium at the isthmic level, thought to be the result of inadequate healing of the uterine incision after cesarean section. It is important not to underestimate isthmocele and to take preventive measures as it can lead to serious gynecologic and obstetric complications. However, which suturing technique is best in preventing isthmocele formation has not yet been established. The aim of this study was to compare the effects of 3 different uterine closure techniques on isthmocele formation during cesarean section.

In this study, a total of 120 term (\>37 weeks) pregnant women with no previous cesarean section and scheduled for primary cesarean section will be randomized preoperatively to 3 different uterotomy closure techniques (baseball, single-lock and non-single-lock groups).

Eligibility Criteria:
Inclusion criteria:

* Pregnant women undergoing C/S for the first time
* 37 weeks \< gestation (term pregnancies)

Exclusion Criteria:

* Presence of regular contractions in the uterus
* Cervical dilatation of more than 4 cm, indicating the onset of the active phase of labour
* Placental abnormalities
* Previous uterine surgery
* Multiple pregnancy
* Premature rupture of membranes
* Chorioamnionitis
* Preoperative haemoglobin level below 10g/dl
* Body mass index (BMI) above 35kg/m2
* Any comorbidity (e.g. diabetes, hypertension, pre-eclampsia, eclampsia)
* Smoking and/or alcohol use
* The need for a blood transfusion.
Early In-bed Cycling in Critically Ill Children

To evaluate the feasibility of conducting a randomized controlled trial (RCT) evaluating the efficacy of early in-bed cycling in addition to usual care physiotherapy, compared to usual care physiotherapy, on functional recovery in critically ill children.

This is a single centre, Pilot RCT that will evaluate in-bed cycling in addition to usual care physiotherapy, compared to usual care physiotherapy, on functional recovery in critically ill children. We will conduct a qualitative substudy to evaluate caregiver impressions of the intervention, and to understand barriers and facilitators to implementing early mobilization in critically ill children.

Eligibility Criteria:
Inclusion Criteria:

1. age ≥ 3 years to \< 18 years;
2. Limited to bed-rest or bed mobility at time of screening
3. expected PICU stay for an additional 48 hours minimum, at time of screening
4. informed consent and or assent where appropriate;
5. agreement of the most responsible PICU physician.

Exclusion Criteria:

1. Contraindications: e.g. Hemodynamic instability, unstable or uncontrolled arrhythmia, ICP, unstable airway, unstable fractures/spine
2. Contraindication to mobilizing upper/lower limbs, e.g. femoral sheath
3. Cycle ergometer does not fit body dimensions
4. Already mobilizing well/expected to mobilize out of bed within 24h
5. not expected to survive current admission - i.e. predicted hospital mortality of \> 90%;
Breath Analysis Based Disease Biomarkers

The purpose of the study is to develop a clinical test based on breath analysis that can be used for disease diagnosis or prognosis.

The study will seek to collect and analyze breath samples from a broad range of patients to develop reference ranges and to refine the testing methods. Protocols for breath sample collection and algorithms for analysis will be developed. Samples will be collected from normal volunteers, persons with documented liver disease, organ transplant or with known COVID-19 test results.

Eligibility Criteria:
Inclusion Criteria:

* Able to provide informed consent

Exclusion Criteria:

* None
A Study to Evaluate the Efficacy of the Nasal Antiseptic, PrevinC, When Administered for the RiskReduction of Rhinitis in Subjects Who Work for Child Day Care Centers

The hypothesis was to establish whether the use of PrevinC administered nasally 2-3 times a day will prevent upper respiratory infections in otherwise healthy adults working in child day care centers.


Eligibility Criteria:
Inclusion Criteria:

* Subject must provide written informed consent prior to the conduct of any study
* Male or female
* 18-65 years of age
* Inclusive
* Employed by one of seven selected Day Care Centers

Exclusion Criteria:

* Recent symptoms of upper respiratory infection, respiratory disease
* Received medication for colds or allergies within 3 weeks of enrolling
* Had nasal surgery within 2 months of enrolling
* Had a pierced nose or wore nose jewelry
Circulating Tumor DNA Exposure in Peripheral Blood

This is a prospective, multi-center, blinded feasibility study. The objective of this study is to test the feasibility of the detection of tumor DNA of a variety of tumors in peripheral blood using a novel process for the detection of circulating tumor DNA (ctDNA).

This prospective, multi-center, feasibility study represents a feasibility study to determine the potential of circulating tumor DNA exposure in peripheral blood using a novel process in a sample of patients with different types of malignant organ tumors and a control cohort without malignant disease. The study applies a new process to detect ctDNA and other molecular markers in peripheral blood using: a collection of de-identified blood specimen and clinical data from up to 10,000 participants from clinical sites across the United States and Europe. Data collected will include the following: Demographics, Tumor Characteristics, Information about Treatment, Specimen Assessment, Postoperative Assessment Clinical information, and Follow-up at intermittent future time points, for up to 15 years. The study test(s) to be used in this protocol is a multiplexed primer and probe design developed, that allows detecting a wider set of mutations at a higher sensitivity then conventional sequencing-based method. This novel process is currently being investigated at Quantgene Inc.

Eligibility Criteria:
Inclusion Criteria:

* This study will include subjects that are diagnosed with a malignancy (cohort

  1) and a negative cohort with subjects that have not been diagnosed with a malignancy (cohort 2).
* Subjects of both cohorts must:

  * Be of age ≥ 18
  * Provide written consent for study participation
* Subject of cohort 1 must:

  * Have a diagnosis of a malignancy in clinical stage 0 to IV including but not limited to: colon or rectal cancer, pancreatic and gastric cancer, hepatocellular carcinoma, non-small cell lung cancer, bladder cancer, melanoma

Subjects of cohort 2 must:

• Meet the listed matching criteria

Exclusion Criteria:

* Subjects of cohort 1 must not: Have been treated for above diagnosed malignancy
* Subjects of cohort 2 must not:

  * Have been diagnosed/treated for a malignancy previously
Dazucorilant in Patients With Amyotrophic Lateral Sclerosis

The purpose of this study is to assess the safety and efficacy of CORT113176 (dazucorilant) in patients with Amyotrophic Lateral Sclerosis (ALS).

Eligible ALS patients will be randomized to one of three treatment arms (1:1:1) across North America and Europe for a 24-week double-blind treatment period.

Patients who complete participation (i.e., completed all visits) in the double-blind treatment period will be eligible for participation in a 132-week open-label extension (OLE) study. A daily dose of 300 mg dazucorilant will be used in the 132-week OLE period.

Patients that complete the double-blind treatment period and who do not enter the OLE will enter the 132-week follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients ≥18 years of age with Sporadic or familial ALS
* If taking riluzole, edaravone, and/or sodium phenylbutyrate and taurursodiol, must be on a stable dose prior to Screening.

Exclusion Criteria:

* History of a clinically significant non-ALS neurologic disorder
* Inability to swallow capsules.
* Human immunodeficiency virus (HIV) or current chronic/active infection with hepatitis C virus or hepatitis B virus
* Women who are pregnant, planning to become pregnant, or are breastfeeding.
* Use of non-invasive ventilation (NIV) or mechanical ventilation via tracheostomy, or on any form of oxygen supplementation.
* Current or anticipated need of a diaphragm pacing system (DPS).
* Currently using glucocorticoids or have a history of regular systemic glucocorticoid use within the last 12 months.
* Previous exposure or treatment with glucocorticoid receptor modulators or antagonists.
Ceftaroline China Pharmacokinetics Study

The purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of ceftaroline in Chinese healthy subjects following single and multiple intravenous doses.

A Phase I, Single Center and Open Label Study to Assess the Safety and Pharmacokinetics of Ceftaroline in Healthy Chinese Volunteers Following Single and Multiple Administration of 600 mg Ceftaroline Fosamil as 60-minute Intravenous Infusion Every 12 hours and as 120-minute Intravenous Infusion Every 8 hours.

Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent prior to any study specific procedures.
* Are healthy male or female Chinese volunteers aged between 18 and 45 inclusive.
* Have a Body Mass Index (BMI) between (and including) 19 and 24 kg/m2 and weigh at least 50 kg.
* Be willing to communicate with the investigator and comply with all study procedures.

Exclusion Criteria:

* Creatine clearance \<80 mL/min as calculated by the Cockcroft Gault equation
* History of any hypersensitivity or allergic reaction to any β-lactam antimicrobial.
* Symptoms of any clinically significant illness within 2 weeks of screening.
* Use of any other investigational compound or participation in another clinical trial within 2 months prior to Visit 2.
* Blood donation with 3 months of screening.
A Study to Asses Wellness Using a Brain Sensing Device on Physicians

A study to asses the feasibility of physicians using a wearable brain sensing wellness device during a time of increased work load, patient volume and stressors to assess the association between duration of active state and calm state as measured by the wearable brain sensing wellness device, and quality of life (QOL), subjective stress, sleep and resilience.

Participants will be instructed on how to use a brain sensing device and corresponding digital application to engage in structured digital mindfulness practices daily for 3 months. Subjects will be requested to use the device and practice daily, but the amount of time and frequency daily will be to their choosing. Subjects will also complete questionnaires and cognitive based testing throughout participation.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older at time of consent
* Practicing Physicians at Mayo Clinic
* Not pregnant by subject self-report at time of consent
* Have the ability to provide informed consent
* Have the ability to complete all aspects of this trial
* Have access to a smart phone or tablet device
* Have no contraindicating comorbid health condition which would interfere with the proper use of the Muse-S™ system, as determined by the clinical investigators

Exclusion Criteria:

* Used an investigational drug within the past 30 days
* Currently (within the past 3 weeks) been practicing mindfulness training on a weekly/regular basis
* Currently (within 3 weeks) been enrolled in another clinical or research program (e.g. CAM) which intervenes on the patients' QOL, or stress
* An unstable medical or mental health condition as determined by the physician investigator
Telephone Call From Acute Care Physicians to Long Term Care Physicians: Impact on Transitional Care of Elderly Patients

A telephone call from a physician taking care of a patient in the hospital to a physician in the long term care setting at the time of discharge can improve transitional care for elderly patients. We believe direct communication between physicians can reduce re-hospitalizations, medication errors, morbidity and mortality. No studies have been done that involve physician-to-physician sign-outs after hospital discharge to the nursing home. In our study, we would like to address the breakdown in the transfer of information to the nursing home setting.


Eligibility Criteria:
Inclusion Criteria:

* patients transitioning from the Acute Care for The Elderly (ACE) Unit patients at Maimonides Medical Center to Metropolitan Jewish Geriatric Center (MJGC).

Exclusion Criteria:

* AGE BELOW 65
Biotin Deficiency and Restless Legs Syndrome

Restless Leg Syndrome (RLS) is a common neuropathic disorder in patients with end stage renal disease (ESRD). Study Design: Because micronutrient depletion has been associated with RLS in ESRD and because the vitamin biotin is dialyzable, the investigators examined the relationship between biotin status and RLS in ESRD. Objectives: To assess the prevalence of biotin deficiency in those with and without RLS (Study 1) and to determine the effect of biotin supplementation on RLS symptoms (Study 2) in patients receiving chronic dialysis due to ESRD.

Setting and Participants: ESRD patients receiving chronic dialysis as outpatients at Saint Patrick Hospital in Missoula, Montana.

Eligibility Criteria:
Inclusion Criteria:

* ESRD requiring hemodialysis or peritoneal dialysis therapy for a duration of at least 3 months.

Exclusion Criteria:

* History of consumption of more than 300 micrograms daily of biotin
* Oral contraceptive therapy containing high amounts of estrogen because studies in rats provide evidence that high doses of steroid hormones reduce biotin status {Wang, 1997 #1634}
* Women of childbearing age because of concern that biotin deficiency may be teratogenic {Mock, 2009 #2568}.
Prasterone (DHEA) for the Treatment of Hypoactive Sexual Desire Disorder (HSDD) - Second Study

The primary objective is to confirm the efficacy of intravaginal prasterone (DHEA) on Hypoactive Sexual Desire Disorder (HSDD) in postmenopausal women.


Eligibility Criteria:
Inclusion Criteria (main criteria):

* Postmenopausal women (hysterectomized or not).
* Women between 40 and 80 years of age.
* Being in a stable relationship with the opportunity for sexual activity or masturbation at least once a month during the last 6 months or longer (before screening visit) and during the following 8 months.
* Diagnosis of HSDD confirmed by a qualified clinician.
* Willing to participate in the study and sign an informed consent.

Exclusion Criteria (main criteria):

* Chronic or acute life stress or major life change that could have interfered and continues to interfere significantly with sexual activity.
* Taking drugs which could be responsible for HSDD.
* Severe medical condition which can explain the loss of sexual desire.
* The administration of any investigational drug within 30 days of screening visit.
* Clinically significant abnormal serum biochemistry, urinalysis or hematology.
Time Course of Endometrium's Gene Expression Profiles Using Endometrial Tissue and Blood Samples

This study aims to investigate whether the expression levels of microRNA (miRNA) in endometrial tissue and blood samples at various time points after ovulation can serve as biomarkers for assessing endometrial receptivity.


Eligibility Criteria:
Inclusion Criteria:

* Regular menstrual cycle of 28-32 days.
* Between 25-38 years old.
* BMI between 18 to 30.
* Endogenous progesterone (P4) level of \< 1 ng/mL prior to exogenous progesterone administration

Exclusion Criteria:

* Suspected intrauterine abnormality.
* Women who are breastfeeding
* Have a history of pelvic inflammatory disease, reproductive tract-related diseases, sexually transmitted diseases, systemic diseases or endocrine diseases.
* History of major illness.
* Use of hormonal contraceptives or intrauterine devices in the past 3 months.