cyrilzakka/clinical-trials huggingface dataset:
Buccal Misoprostol During Cesarean Section for Preventing Postpartum Hemorrhage

Objective: to demonstrate that buccal misoprostol administration during cesarean delivery in women with risk factors for uterine atony decreases the need for additional uterotonic medications, uterine atony and postpartum hemorrhage.

Design: randomized, double-blinded, placebo-controlled trial.

Patients and methods: 120 pregnant women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to either 400 mcg misoprostol (n=60) or placebo (n=60) placed in buccal space after umbilical cord clamping. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.

Eligibility Criteria:
Inclusion Criteria:

* Women who underwent delivery either by elective or emergent cesarean section at 24 week gestation or later with preoperative levels of hemoglobin and hematocrit determined up to 72 hours prior to delivery. The patients must have at least one of the risk factors for uterine atony listed below:

  1. Fetal macrosomia (estimated fetal weight ≥ 4 Kilos) diagnosed by clinical measurement (Johnson´s technique) or ultrasound measurement (Hadlock´s formula).
  2. Polyhydramnios (defined as Phelan´s amniotic fluid index \> 24 cm)
  3. Twin or Multiple pregnancy.
  4. Prolonged labour (prolonged active phase \> 12 hours) or precipitate labour(cervical dilatation ≥ 10 cm/hour).
  5. Magnesium sulphate or any other tocolytic agent therapy for ≥ 8 hours before cesarean section.
  6. Intravenous oxytocin therapy for at least 4 hours before cesarean section.
  7. Multiparous women (≥ 3 prior abdominal or vaginal deliveries )
  8. Clinical chorioamnionitis was defined as maternal temperature of ≥ 38°C in addition to more than one of the following criteria: fetal tachycardia (\> 160 beats per minute), maternal tachycardia (\>100 beats per minute, maternal leukocytosis (15,000 cells/mm3), uterine tenderness or foul smelling amniotic fluid.
  9. Known myomatosis, uterine Müllerian malformations or those diagnosed by ultrasound.

Exclusion Criteria:

1. Misoprostol incorrect administration
2. Severe allergic, bleeding disorders (e.g., haemophilia); severe asthma or any other absolute contraindication to misoprostol use.
3. Any bleeding occurred before delivery (abruptio placentae, placenta praevia) or bleeding due to other causes different than uterine atony.
Effect of Advanced Care at Home vs. Traditional Brick-and-Mortar Hospital Care in Acutely Ill Adults: A Randomized Clinical Trial

The purpose of this study is to compare two care delivery models that are currently being implemented in routine practice settings. The findings from this study will inform future clinical decision making, such as which patients might be more suited for which care delivery model.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, 18 years of age and older.
* Present to one of the participating hospitals.
* Have a chief complaint of one of the target diagnoses.
* Are within a certain geographical area (based on zip codes).
* Have a health insurance plan that covers ACH services.
* Have the capacity to consent or could assent with the consent of a health care proxy who is physically present.

Exclusion Criteria:

* The patient is not suitable for ACH or inpatient hospital care based on:

  * being a nursing home patient;
  * on or requiring dialysis;
  * positive for COVID-19;
  * having discharge order;
  * requiring intensive care unit (ICU) level of care;
  * history of drug abuse.
* Patients will also need to meet the clinical stability criteria.
* Do not have the capacity to consent or assent with the assistance of a health care proxy.
An Observational Study to Evaluate Effectiveness and Safety of Amosartan Plus Tablet

This study was to evaluate the therapeutic effect and safety of Amosartan Plus tablet administration in uncontrolled essential hypertension patients.

During the routine medical visit, Amosartan Plus tablets were administered to patients in need of blood pressure control according to the investigator's judgment.

In this study, effectiveness and safety information of treatment of Amosartan Plus tablets was followed for 6 months (up to 12 months), and observation of the target patients was terminated after collecting relevant data.

As this study was a non-interventional observational study, all patients received prescriptions according to the routine treatment procedure, and there were no visits or procedures required according to the observational study protocol.

This study was a multi-center, prospective, non-interventional, observational study of factors affecting blood pressure after treatment with Amosartan Plus tablet in uncontrolled essential hypertension patients.

Data was collected from patients receiving routine treatment at hospitals in South Korea. Each patient visited the institution according to the protocol that designed the follow-up visits for six months to examine the effectiveness and safety of Amosartan Plus tablet.

This study approved by the institutions' IRBs and was conducted in compliance with clinical research ethics regulations.

Eligibility Criteria:
Inclusion Criteria:

* Uncontrolled essential hypertension patients
* Those who have already decided to administer Amosartan Plus tablet under the medical judgment of the researcher
* Those who voluntarily decided to participate in this study and consented in writing to the consent form

Exclusion Criteria:

* Patients for whom use of Amosartan Plus tablet is prohibited
Arterial Catheter to Monitor Glycemia

The technique of blood samples extraction from the radial artery through an arterial catheter with a 3-way stopcock and automated washing with valve of fast flow is better than the one carried out through a fixed reusable arterial blood sample syringe and its manual washing because it shows a minor incidence of the complications originated from technical manipulation as infection, pseudo-aneurysm, ischemia or thrombosis of radial artery or obstruction of the catheter.

The purpose of this study is to evaluate the efficacy, in terms of adverse effects, of blood samples obtention using an arterial catheter with needless connector closed system or an arterial catheter with an arterial blood sample syringe.

Also a second purpose is to compare once a day (at the same time) the values of glycose blood levels between bedside glucometer determination of arterial catheter extraction and capillar puncture, and lab determination of glycose from venous puncture, in order to determinate fluctuation in glycose levels due to peripherical hypoperfusion or to vasoactive drugs received by these in-intensive care unit patients.


Eligibility Criteria:
Inclusion Criteria:

* Admission in intensive care unit
* Insertion of a radial artery catheter for the invasive monitoring of haemodynamic pressure for a maximum of 5 days
* Need of insulin therapy by an intravenous continuous perfusion

Exclusion Criteria:

* Patients who do not accept to participate (or their relatives do not accept)
* Patients with a medical limitation of effort therapy
* Patients with FloTrac sensor from Edwards Lifesciences which does not allow to add a supplementary 3-way stopcock
Effects of Healing Touch on Patients Undergoing Hematopoietic Stem Cell Transplant

This randomized pilot clinical trial studies healing touch or usual care in improving quality of life in patients undergoing stem cell transplant. Healing touch may improve the quality of life of patients undergoing stem cell transplant.

Primary Objectives:

I. To estimate the effects of healing touch (HT) vs usual care in the following clinical outcomes of stem cell transplant (SCT) patients; length of hospital stay, days to engraftment, and number of hospital readmissions during 100 days post-transplant.

II. To estimate changes in quality of life (QoL) which occur during hospitalization of SCT patients who receive HT vs. usual care.

III. To examine differences in effects of HT vs. usual care (UC) in patients receiving related allogeneic (Allo) transplant compared to those receiving autologous (Auto) transplant.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive daily HT sessions comprising pain drain, chakra connection, magnetic clearing, and mind clearing over 30 minutes from day 1 until 2 days before discharge from the hospital.

ARM II: Patients receive routine nursing care from doctors and nurses from day 1 until 2 days before discharge from the hospital.

After completion of study treatment, patients are followed up for 100 days.

Eligibility Criteria:
Inclusion Criteria:

* Currently undergoing autologous (auto) or related allogeneic (related allo) stem cell transplantation
* Admitted to the University (U) Adult Blood and Bone Marrow Transplant Unit (UIBMTU) of the University of Iowa Hospitals and Clinic
* Ability to provide written informed consent obtained prior to participation in the study and able to complete questionnaires
* Pregnant woman who are eligible for stem cell transplant are included in this study

Exclusion Criteria:

* Patients with any significant history of non-compliance to medical regimens, with inability to grant a reliable informed consent or unable to complete questionnaires
* Patients with evidence of a significant psychiatric disorder by history that would prevent completion of the study will not be allowed to participate, i.e., schizophrenia, anxiety disorder, major depressive disorder and bipolar disorder
* Diagnosis of dementia or other disease affecting cognitive function
* Nursing women are excluded
Efficacy, Safety and Adherence of Patients Infected With Hepatitis C Virus in Retreat With INFERGEN (Interferon Alfacon1)

This is a Phase 4, descriptive, observational, open, prospective study of patients who their doctor prescribes INFERGEN for clinical practice. No medication was provided by the sponsor. The planned observation time is 48 weeks and 24 weeks of follow-up.

Each investigator participating in this registry will employ his or her discretion and standard clinical practice to determine when to see the patient in the clinic, how to manage the patient's drug regimen, and how best to monitor the patient's response and tolerance to therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Willing to consent to data being collected
2. Considered by the investigator as an appropriate patient for treatment with INFERGEN in retreatment.
Clinical and Histological Assessment of Free Gingival Graft or Collagen Matrix for Socket Sealing After Bone Grafting

The goal of this study was to compare, clinical and histologically, the use of the suine collagen matrix (Mucograft Seal \[MS\], Geisthlich®) and the free gingival graft (FGG) for the alveolar sealing after inserted bone graft biomaterial. It was included 18 patients with tooth referred to extraction (maxilar incisives, canines, or pre-molars) which were randomly divided in 2 groups, according to the material for alveolus sealing: control (FGG) and test (MS). After the minimally traumatic extraction, all the alveoli were filled with bovine mineral matrix (Bio-Oss®), and the material for alveolar sealing were positioned and stabilized with sutures. The follow-up (clinical and photographic) happened on the immediate post-operatory period, and with 3, 7, 15, 30, 60, 90, and 120 days. After 120 days, before implant placement, tissues samples were obtained with a 3.5mm punch scalpel for histological analysis. Qualitative information related to the patient's perception considering the treatment were collected.


Eligibility Criteria:
Inclusion criteria

* patients ASA I
* patients requiring single tooth extraction in the site between #4 to #13
* patients without enough bone volume for immediate implant placement.

Exclusion criteria

* patients with general contraindications for implant surgery
* pregnant or lactating women
* patients with untreated periodontitis
* bruxism or severe clenching
* immunosuppressed
* patients with a previous history of irradiation of the head and neck area
* uncontrolled diabetes
* heavy smoker (\>10 cigarettes/day)
* poor oral hygiene and low motivation
* use of bisphosphonates
* substance abuse such as alcohol or drugs and psychiatric disorders.
The Risk of Uncomplicated Peptic Ulcer in a Cohort of Secondary Prevention Aspirin Users

This study is conducted in a cohort of low dose aspirin (ASA) users previously ascertained. The aims of the post hoc analyses are:

To estimate the incidence of uncomplicated peptic ulcer (UPU) in a cohort of low-dose ASA for secondary prevention of vascular disease and the relative risk of UPU associated with use and discontinuation of use of low dose ASA.

To estimate the effect of proton pump inhibitors (PPI) on the occurrence of UPU among users of low-dose ASA for secondary prevention of vascular disease To evaluate the effect of other risk factors on the occurrence of UPU among users of low-dose ASA for secondary prevention of vascular disease.

The risk of uncomplicated peptic ulcer in a cohort of secondary prevention aspirin users

Eligibility Criteria:
Inclusion Criteria:

- Patients aged 50-84 years in 2000-2007 with a first prescription of low dose ASA ( see study population description)

Exclusion Criteria:

- Patients aged below age 50 and 85 years and above ( see study population description)
A Trial Comparing Ferumoxytol With Placebo for the Treatment of Iron Deficiency Anemia

To evaluate the efficacy and safety of intravenous (IV) ferumoxytol compared with placebo for the treatment of iron deficiency anemia (IDA).

This Phase III, randomized, double-blind, placebo-controlled, multicenter clinical study evaluated the safety and efficacy of ferumoxytol compared with placebo for the treatment of IDA, specifically in adult patients with IDA who have a history of unsatisfactory oral iron therapy or in whom oral iron could not be used. The effect of ferumoxytol on hemoglobin, iron parameters and patient reported outcomes (PROs) compared with placebo was evaluated. Investigators were blinded to key laboratory parameters that could potentially unblind the treatment arms of the study, eg, hemoglobin \[Hgb\], hematocrit \[Hct\], iron, ferritin, total iron binding capacity \[TIBC\], and transferrin saturation \[TSAT\], and neither the Investigators nor the subjects were aware of their treatment assignment, hemoglobin or other laboratory values.

Eligibility Criteria:
Key Inclusion Criteria include:

1. Males and females ≥18 years of age
2. Participants with IDA defined as having:

   1. Hemoglobin \<10.0 g/deciliter (dL)
   2. Transferrin saturation \<20%
3. Participants who have a history of unsatisfactory oral iron therapy or in whom oral iron cannot be used
4. Female participants of childbearing potential who are sexually active must be on an effective method of birth control for at least 1 month prior to screening and agree to remain on birth control until completion of participation in the study

Key Exclusion Criteria include:

1. History of allergy to IV iron
2. Allergy to two or more classes of drugs
3. Participants on dialysis or with an estimated glomerular filtration rate \<30 mL/minute/1.73 m\^2
4. Female participants who are pregnant, intend to become pregnant, are breastfeeding, within 2 weeks postpartum, or have a positive serum/urine pregnancy test
5. Hemoglobin ≤7.0 g/dL
6. Serum ferritin \>600 nanograms/mL
The Need for Supplemental Blocks in Infraclavicular Brachial Plexus Blocks

Theoretically, all surgeries below mid-humerus can be done under infraclavicular (IC) blocks. Following the introduction of ultrasonography (USG) to clinical anesthesia, plexus, and nerve blocks under the guidance of USG have gained wide acceptance for the high rates of block success and low risk of complications (1). In this study, the main aim is to evaluate the single injection and triple injection techniques in IC blocks with a USG-guided medial approach in terms of block success and the need for supplementary blocks. The secondary goals are to compare the complication rates and sensory block durations and to discuss the possible reasons for the failure of the blocks.

Theoretically all surgeries below mid-humerus can be done under infraclavicular (IC) blocks. Following the introduction of ultrasonography (USG) to the clinical anesthesia, plexus and nerve blocks under the guidance of USG have gained wide acceptance for the high rates of block success, and low risk of complications. At the same time, it was also shown that USG-guided IC blocks can shorten procedural times and accelerate the onset of the blocks.

Several methods for IC blocks have been described. Based on the anatomical knowledge, we hypothesized that in medial approaches the need for supplementary blocks would be low with single injections as well as triple injections. In this study, the main aim is to evaluate the single injection and triple injection techniques in IC blocks with a USG-guided medial approach in terms of block success and the need for supplementary blocks. The secondary goals are to compare the complication rates and sensory block durations and to discuss the possible reasons for the failure of the blocks.

Medical records of 139 patients scheduled for elective or emergent hand, wrist, forearm, elbow, and distal arm surgery were analyzed. Patients older than 14 years with ASA physical status I-III who underwent surgery between October 2017 and March 2019 were retrospectively evaluated. Exclusion criteria included non-cooperative patients, refusal of the regional anesthesia, known neuropathy that could prevent the evaluation of the efficacy of the block, different techniques used for infraclavicular brachial plexus blocks (lateral sagittal, coracoid, ...etc.), and known allergy to local anesthetic drugs.

Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I-III
* upper extremity surgery
* blocks were performed by the same anesthesiologist

Exclusion Criteria:

* non-cooperative patients
* refusal of the regional anesthesia
* known neuropathy
* different technique used for infraclavicular brachial plexus blocks (lateral sagittal, coracoid, ...etc.)
* known allergy to local anesthetic drugs.
Chronicling the COPD Patient Journey and Change in COPD Symptoms, Quality of Life and Exacerbations Following Initiation of Budenoside/Glycopyrronium/Formoterol [BGF]

The CHRONICLES study will investigate the change in clinical and patient reported outcomes after six-months of treatment with Budenoside/Glycopyrronium/Formoterol \[BGF\] in a real-world setting.

This is a prospective, open label, non-interventional, single network of clinical practice centers study that will be conducted in routine clinical care in the pulmonary/ primary care practitioner (PCP) care setting in Ontario, Canada. Eligible patients will be enrolled into the study only following the treating physician's decision and patient agreement to initiate treatment with BGF. Patients will be observed for up to 6 months post-treatment initiation with BGF.

Eligibility Criteria:
Inclusion Criteria:

* Physician diagnosis of COPD
* COPD patients in the Best Care Network who have a CAT score \>=10
* Age \>=35 at time of enrolment
* Minimum 12-month recorded prior medical history for patients
* Physician decision and patient agreement to initiate treatment with Breztri based on routine care (and in accordance with label and reimbursement criteria)
* Ability to read English and to provide consent to inclusion in the study

Exclusion Criteria:

* Diagnosis of asthma
* Dementia or other health issues related to memory
* Inability to use inhalers
* COPD due to documented α-1 antitrypsin deficiency
* Previous treatment with triple fixed-dose combination therapy in 12 months prior to screening visit
* Hospitalisation due to COPD exacerbation within the last 30 days prior to enrolment
* Pregnancy or lactation period
* Participation in an ongoing clinical interventional or observational trial for another COPD medication (or completed another trial within last 30 days of initiating BGF)
* Patient self-reporting or a physician record with an active COVID-19 infection at time of enrolment or hospitalized due to COVID-19 infection in the last 60 days
* Previous enrolment in this study
Radiation-free Bone Imaging UTE MRI in Healthy and Diseased Patients

In summary, the investigators want to investigate whether UTE sequences are capable to replace imaging techniques involving ionizing radiation for bone imaging in the future. This would improve patient care greatly and might reduce medical imaging associated cancer risk drastically from an epidemiological standpoint. This field of research can be considered cutting-edge. The investigators determine this study promising to provide substantial generalizable knowledge and hope that this study results will improve patient care worldwide considerably.

To date, definite depiction of anatomy or pathologies of bony structures requires ionizing radiation by using radiographs or computed tomography (CT) since conventional magnetic resonance imaging (MRI) that does not require ionizing radiation cannot depict bony structures well. Modern MR techniques, collectively referred to as ultrashort time to echo (UTE) sequences, have overcome this issue by acquiring the signal data much faster and therefore are able to acquire sufficient MR signal from bony structures. The investigators want to investigate if UTE sequences are capable to depict bony anatomy and pathology similar to imaging examination techniques involving ionizing radiation. Healthy adult and minor participants, as well as adult and minor participants, referred for a clinically indicated MRI involving the skeletal system will be included.

Eligibility Criteria:
Inclusion criteria:

* adults and minors (all ages) capable of giving informed consent or have a legal representative capable of giving consent on the participant's behalf. Informed Consent as documented by signature (Appendix Informed Consent Form)
* for participants referred for a clinical indicated MRI (primary objective) inclusion criterion is the presence of radiographs or a CT scan of the part of the skeletal system that is under investigation within the clinical indicated MRI
* for healthy volunteers (secondary objective) any volunteer that is not referred for a clinical indicated MRI scan

Exclusion criteria:

* women who are pregnant
* general known contraindications for MRI (e.g., non-MR compatible pacemaker)
* homeless persons, or persons with active drug/alcohol dependence or abuse history
The Physiological Effect of RCexp on Ventilation/Perfusion Distribution

With the exception of setting the positive end-expiratory pressure (PEEP), the expiratory phase is commonly overlooked during MV. The expiratory time constant (RCexp) plays an important role in understanding the mechanical properties of the respiratory system in patients receiving mechanical ventilation. However, it is unclear that the effect of expiratory time constant on the ventilation and perfusion distribution.

With the exception of setting the positive end-expiratory pressure (PEEP), the expiratory phase is commonly overlooked during MV. The expiratory time constant (RCexp) plays an important role in understanding the mechanical properties of the respiratory system in patients receiving mechanical ventilation. However, it is unclear that the effect of expiratory time constant on the ventilation and perfusion distribution.

Eligibility Criteria:
Inclusion Criteria:

adult patients with ARDS receiving mechanical ventilation no more than 72 hours

Exclusion Criteria:

1. age \<18 years old
2. patient undergoing legal protection
3. contra-indications to EIT (e. g. severe chest trauma or wounds)
4. pneumothorax
5. patient undergoing ECMO
6. pregnancy