cyrilzakka/clinical-trials huggingface dataset:
Reduction of Perineal Pain After Vaginal Birth With Black Tea: Pilot Randomized Study

Perineal trauma is common during vaginal birth. The discomfort this causes can interfere with a woman's recovery and early motherhood.Mothers are offered a standard treatment after childbirth, water soaked frozen peri pads (ice packs), to alleviate the discomfort. However, a Cochrane review questions the efficacy of ice packs treatment. An alternative treatment that may be more comfortable and effective for women is warm water soaked black tea bags. Medicinal use of black tea bags has been based on their astringent (shrinking or constricting) properties and have been used for various medical applications.

The investigators will conduct a pilot randomized controlled trial (RCT) of 40 pregnant mothers randomized to either intervention group (tea bags; n=20) or control group (ice packs; n=20). The goal of this pilot is to test the feasibility of a larger RCT by assessing recruitment, testing the protocol, and evaluating a proposed primary outcome objective of analgesic use during hospitalization as an indicator of pain. The investigators expect this pilot study to demonstrate feasibility for a large scale RCT to formally evaluate the efficacy of black tea bags to reduce perineal pain in this patient population.


Eligibility Criteria:
Inclusion Criteria:

* Primiparous women (delivering their first baby) over the age of 19 who have delivered vaginally at Abbotsford Regional Hospital and Cancer Centre

Exclusion Criteria:

* multiparity (women who have delivered vaginally more than once), VBAC (Vaginal Birth after Cesarean Section), active sexually transmitted infection lesions, vulvar varicosities, third and forth degree perineal tear, hematoma, retained placenta/products, substance abuse, and other medical conditions requiring frequent analgesia
Thoracic Lymphatic Pump Technique Exercises Chronic Mechanical Low Back Pain

The purpose of the study is to compare between the combined effect of thoracic lymphatic pump technique with exercises and exercises alone on pain intensity using Visual Analogue Scale (VAS), lumbar spine mobility using Modified-Modified Schober test (MMST) and functional disability level using Oswestary Disability Index (ODI) on patients with CMLBP.

Study design: This study will be randomizaed controlled trail.1. Participants:forty-two patients with chronic mechanical low back pain. age:20-45. Th sample size population: was calculated using the G\*power program 3.1.9 (G power program version 3.1, Heinrich-Heine-University, Düsseldorf, Germany) for one tailed test. Sample size calculation based on F tests (ANOVA: Special effects and interactions), Type I error (a) = 0.05, power (1-ß error probability) = 0.80, Pillai V = 0.3300000 and effect size f (V) = 0.8 with 2 independent groups comparison for 3 major variable outcomes. The appropriate minimum sample size for this study was 42 patients (21 patients in each group). Procedure:First, the purpose of the study will be explained to the patients and the procedures are fully explained. Then, patients will be asked to participate in the study. If they accepted, an informed consent form will be signed and randomly assigned in one of two groups (by closed envelope method). All subjects will be evaluated for their pain intensity,lumbar spine mobility and functional disability level. All patients will be tested before and after the treatment program (12 treatment sessions, 3 sessions per week for 4 weeks). Each patient will receive exercises (stretching and strengthening exercises) for the control group (A), the stretching exercises include (Hamstring stretching- Lower back stretching) and the strengthening exercises- include (Abdominal curl up- Supine bridging-Trunk extension). For the experimental group (B), they will receive exercises (stretching and strengthening exercises) then the thoracic lymphatic pump technique.

Eligibility Criteria:
Inclusion Criteria:

* Patients (both genders) with a chief complain of Chronic mechanical low back pain without leg pain (Al Sulaimy et al., 2018).
* Age of the patient 20- 45 years old (Al Sulaimy et al., 2018).
* Pain more than three months

Exclusion Criteria:

* Patient with Spondylolysis (Steele et al., 2016).
* Patient with tumor, infection (Ulger et al., 2017).
* Patient with cauda equina syndrome who need urgent surgery (Ulger et al., 2017).
* Patients with previous lumber surgery (Amundsen et al., 2018).
* Patient with Deep venous thrombosis (DVT) (Alves et al., 2020).
* Patient with Congestive heart failure (Alves et al., 2020).
* Patient with Renal failure (Forner-Cordero et al., 2021).
* Patient with uncontrolled hypertension (Forner-Cordero et al., 2021).
Youth Participatory Action Research to Prevent Community Violence Among Black Youth

This behavioral intervention study aims to evaluate the effectiveness of Youth Empowered Advocating for Health (YEAH) on youth prosocial behavior and aggressive behavior and assess racial identity and future orientation as mediators of prevention effects.

Structural determinants of violence such as residential segregation, concentrated poverty, and limited access to education and employment, disproportionately affect Black youth. This group subsequently faces the highest rates of violence exposure and related injuries, with homicide being a leading cause of death. In addition, the consequences of violence exposure include academic decline, psychological issues, and chronic health conditions.

It is important to address the long-lasting effects of structural violence among Black youth including emotional distress and eroding family and community ties. Current violence prevention methods often overlook the impact of structural violence.

The proposed solution is a Youth Participatory Action Research (YPAR) intervention, called Youth Empowered Advocating for Health (YEAH), which aims to empower Black youth and improve their outcomes. The YEAH program, developed over ten years in partnership with youth, focuses on empowering youth to explore topics of concern in their community and generate solutions. This study will evaluate YEAH's effectiveness in reducing community violence in Metro Atlanta, emphasizing community healing and empowerment as well as narrative change as vital strategies for prevention.

Eligibility Criteria:
Inclusion Criteria:

* Identify their race or ethnicity as Black or African American
* Speak English
* Able to understand the project and give full consent to participate if eligible
* Have a parent or guardian provide consent for them to participate
* Member of Boys and Girls Clubs or other Youth Serving Organization (YEAH immediate intervention and delayed intervention groups)

Exclusion Criteria:

* Non-English speakers
Investigation of a Novel Turbine-driven Ventilator for Use in Cardiopulmonary Resuscitation

The objective of this study is to determine whether healthcare professionals trained in CPR can deliver more effective ventilations during CPR using the Handivent, a novel turbine-driven ventilator as compared to bag-valve-mask ventilations, using a manikin model. The investigators believe the Handivent will deliver a more accurate respiratory rate and tidal volume, with lower intrathoracic pressure during CPR.

Previous studies have shown that increased respiratory rate during CPR inversely correlates with blood pressure. Higher respiratory rates increase intrathoracic pressure, which in turn decreases venous return to the heart.

In one previous study, the authors looked at 3 groups of 7 pigs, ventilated at 12 (100% O2), 30 (100%), and 30 (5% CO2, 95% 02) breaths per minute during cardiac arrest, and showed increased mortality with increasing respiratory rate. Survival rates were 6/7, 1/7, and 1/7 respectively. The results of this study led to changing the CPR guidelines in 2005 to include fewer ventilations.

The authors also observed 13 cases of CPR in the field and noted EMS personnel delivered breaths at an average of 32 bpm.

In 2012, a similar study to the current study under proposal compared a pressure-limited, pneumatically driven ventilator to bag-valve-mask in simulated CPR, using medical student volunteers. That study did not show a significant difference in tidal volumes; however, they did not record respiratory rates or mean intrathoracic pressures. Furthermore, that ventilator was pneumatically -driven and pressure limited, whereas the ventilator we propose to study is turbine-driven and can be volume/time triggered.

Eligibility Criteria:
Inclusion Criteria:

* ACLS- certified healthcare professional

Exclusion Criteria:

* none
Clinical Performance of XPEO-E Liner in SERF Dual-mobility Cups

XPEO-E liner is CE marked under MDD 93/42/CEE by equivalency with CI E liner. No pertaining data on XPEO-E liner is yet available. However, clinical evaluation concludes on a reaching of performance and safety and compliance with essential requirements. This study intends to collect data on XPEO-E in order to allow a transit to MDR 2017/745 (EU).

XPEO-E liner is intended to be used with NOVAE cups and SERF femoral heads and Stems. XPEO-E liner will be used according to their CE marking. These devices are intended for hip replacements with the aim of improving quality of life and reducing pain by replacing a damaged joint.

The follow-up visits are established according to the current practice. Additional procedure will only consist on questionnaires that will be filled by the patient and/or the surgeons.


Eligibility Criteria:
Inclusion Criteria:

* Male or female adults.
* Patient that needs to be implanted with a SERF total hip prosthesis.
* Patient responding to IFU requirement.
* Patient affiliated to French social security.
* Patient who has provided a dated and signed informed consent form.

Exclusion Criteria:

* Patient protected by a French legal measure (under legal protection, guardianship or curatorship).
* Patient unable of expressing consent, according to the investigator.
* Patient deprived of liberty or hospitalized against his consent.
* Pregnant or breastfeeding patient.
* Patient presenting a contraindication to the implantation of medical devices according to the instructions for use.
* Patient with a contraindication to radiographic follow-up.
* Patient not being, a priori, capable of respecting the schedule of follow-up visits, according to the investigator.
* Patient unable to complete a self-questionnaire, according to the investigator.
A Study Investigating Properties of the Transversus Abdominis Plane Block

In this study we investigate the following properties of the transversus abdominis plane block in healthy volunteers:

1. Cutaneous analgesic distribution
2. Muscular affection
3. Reproducibility


Eligibility Criteria:
Inclusion Criteria:

* Capable
* American society of anesthesiologists classification 1 or 2
* Written informed consent

Exclusion Criteria:

* Age below 18 years
* American society of anesthesiologists classification above 2
* Body weight below 50 kg
* Body mass index \> 35 kg/m2
* Previous abdominal surgery
* Acute or chronic pain
* Use of pain medication less than 24 h prior to study start
* Allergy to local anesthetics
* Pregnancy
* Breastfeeding
Hemodynamic Effects of Terlipressin and High Dose Octreotide

The purpose of the study is to find patients's response to terlipressin and octreotide during hepatic venous pressure gradient measurement by observing portal and systemic hemodynamics.

Esophageal variceal bleeding is one of the main causes of death in cirrhosis patients. Prevention of bleeding events, including primary and secondary prophylaxis, is very important for reducing the mortality of variceal bleeding. Terlipressin and octreotide can effectively control bleeding with few side effects, which has been recommended by Baveno V in treatment of acute variceal bleeding. Terlipressin and high dose octreotide will be administered to the patients with cirrhosis related esophageal varices when they undergo hepatic venous pressure gradient measurement. Changes from portal and systemic hemodynamics will be observed to evaluate the safety and effects of terlipressin and high dose octreotide as well as to determine wether patients respond to them. The results can be served as clinical evidence for preventing re-bleeding through long-acting terlipressin and octreotide in the future.

Eligibility Criteria:
Inclusion Criteria:

* Gastric and Esophageal Varices have been confirmed through endoscopy
* Liver Biopsy, CT or MRI indicates cirrhosis
* Patients who experienced variceal bleeding

Exclusion Criteria:

* The patients who are beyond the range from 18 to 80 years old
* The patients with unstable vital signs
* The patients with spontaneous peritonitis or other severe infections
* The patients with hepatorenal syndrome or renal inadequacy
* The patients with uncontrolled hepatic encephalopathy
* Pregnant and lactating women
* The patients who had contraindications for terlipressin or octreotide
* The patients who refuse to take part in this study
Rescue Quadratus Lumborum Blocks for Post-cesarean Pain

The purpose of this study is to assess whether quadratus lumborum (QL) block performed 1 day after cesarean delivery will provide supplemental post-cesarean analgesia and reduce opioid requirements.


Eligibility Criteria:
Inclusion Criteria:

* elective or non-elective cesarean delivery on prior day
* pain scores \>5/10

Exclusion Criteria:

* BMI \>40
* obstructive sleep apnea
* drug abuse
* chronic pain
* chronic opioid use
* abdominal surgeries other than cesarean delivery
* contraindications to neuraxial or regional anesthesia
* received general anesthesia or did not receive neuraxial morphine for cesarean delivery
Imaging Based Dosimetry for Individualized Internal Emitter Therapy

The goal of this study is to develop imaging based methods to accurately determine the energy absorbed (absorbed dose) by tumor tissue and bone marrow after radioimmunotherapy with I-131 tositumomab . The administration of the radioactive, iodine-131 labeled, monoclonal antibody I-131 tositumomab, (also known as Bexxar) is part of the patient's clinical treatment protocol. For the absorbed dose measurement, investigators at the University of Michigan are evaluating a new Nuclear Medicine SPECT/CT imaging system . This new camera combines a CT imaging system in addition to a Nuclear Medicine SPECT scanner. CT scans allow the doctors to see a high quality picture of your internal organs. The Nuclear Medicine SPECT scanner allows the doctors to see the uptake of the radioactive I-131 including the tumor sites. The improved imaging using the SPECT/CT enables more accurate calculation of the energy absorbed by tumor tissue and bone marrow. Using the results from these calculations and clinical follow up data, the researchers will investigate the relationship between the absorbed dose to the tumor and the patient's tumor response as well as the relationship between the absorbed dose to the bone marrow and the bone marrow toxicity. These relationships can potentially be used in the future by doctors to help determine how much radioactive I-131 to administer to each patient to get optimal results.


Eligibility Criteria:
Inclusion Criteria:

* • Clinically stable patients undergoing I-131 Tositumomab (Bexxar) for treatment of Non-Hodgkin Lymphomas

Exclusion Criteria:

* • Clinical instability

  * Patients who are unable to lie flat on the imaging systems long enough to permit imaging protocols to be performed
  * Refusal to provide informed consent
  * Patients who are pregnant
The Effect of Restrictive Fluid and Vasopressin During Surgery of Burn Patients

This is a randomized double-blinded study to investigate in which the groups are designated as the control group and the restrictive group to further evaluate significant differences in intraoperative blood loos during burn surgery.

This is a randomized double-blinded study to investigate the effect of fluid restriction and vasopressin on blood loss during surgery of the burn patients. The groups are designated as the control group and the restrictive group to further evaluate significant differences in intraoperative blood loss during the surgery.

Eligibility Criteria:
Inclusion criteria:

* age ≥ 18 years old
* burn patients undergoing surgery (TBSA \> 20%)

Exclusion criteria:

* age \< 18 years old
* history of renal disorder
* history of cardiac disorder
Diurnal Variation of Exogenous Peptides (GH Puls/Jurgita I)

This is an exploratory trial with four cross-over arms measuring the pharmacokinetic and pharmacodynamic profiles of growth hormone using two different modes of growth hormone administration (subcutaneous infusion into the abdomen or subcutaneous bolus injection in the thigh) in 8 adult male or female patients with growth hormone deficiency during interval exercise or in supine rest. The order of dosing regimen within the groups and between the groups will be randomised. All patients will go through four different treatment sessions:A/B Single subcutaneous bolus injection, supine rest without/with interval exercise, sessions C/D: Continuous subcutaneous infusion, supine rest without/with interval exercise. Hypotheses: 1) There is day-to-day variation of exogenous growth hormone, 2)Concentration of growth hormone decreases due to exercise compared to supine rest, 3)There is a circadian variation in pharmacokinetics of exogenous growth hormone infused subcutaneously

The subjects will attend a screening visit and four treatment sessions. The dosing visits will comprise either 2-day hospital stay for the bolus injection group or 3 day hospital stay for the infusion group.

Eligibility Criteria:
Inclusion Criteria:

* AGHD male or female subjects
* Stable GH replacement therapy for at least 3 months
* Body Mass Index 18,5 to 35.0 kg/m2
* Achieved final height
* Age ≥ 18 years

Exclusion Criteria:

* Known or suspected allergy to trial product or components of the trial product
* Subjects with active malignancy
* Severe cardiac insufficiency classified according to NYHA III-IV
* Unstable angina pectoris, acute myocardial infarction within the last 12 months
* Severe, uncontrolled hypertension: sitting blood pressure \> 180/110 mmHg
* HbA1C \> 7,5 %
* Impaired kidney function: plasma creatinine ≥ 150 umol/l according to the hospital lab.
* Impaired liver function: liver parameters exceed 2 times or more the upper normal limit, according to the hospital lab.
* Patients on insulin treatment
* Stable pituitary replacement therapy for less than 3 months
* Participation in any other clinical trial involving any investigational products within the last three months prior to this trial
* Any diseases judged by the investigator that could affect the trial
* Women of fertile age, who are pregnant, planning to become pregnant or breast-feeding. Women of fertile age, who are not currently using adequate contraception methods such as: contraceptive pills, IUD or who had not undergone hysterectomy or sterilization
The Treatment of Hepatocirrhosis and Portal Hypertension

This study compare the efficiency of partial splenic embolization +endoscopical therapy with endoscopical therapy alone in gastroesophageal variceal haemorrhage accompanied with splenomegaly or hypersplenism of hepatocirrhosis and portal hypertension treatment.

Endoscopic therapy is the mature treatment of gastroesophageal variceal haemorrhage and PSE is an effective method for treatment of the hypersplenism and portal hypertension. Existing researches show that endoscopic therapy + PSE is more effective than endoscopic therapy alone in prevention of esophageal varices bleeding recurrence in the patients with liver cirrhosis. However, there is few articles which proved long-term effectiveness of endoscopic therapy + PSE, it needs further research on this issue. This study compares the efficiency of partial splenic embolization +endoscopic therapy with endoscopic therapy alone in the treatment of gastroesophageal variceal haemorrhage accompanied with splenomegaly or hypersplenism in the patients with hepatocirrhosis and portal hypertension.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 18 and 75 years
* Patients who had recovered from an episode of VH or patients who had survived from acute VH and there was no bleeding for consecutive 5 days
* Patients with a diagnosis of liver cirrhosis and portal hypertension on clinical examination, laboratory test, and imaging or histological examination
* Patients with hypersplenism and thrombocytopenia (platelets \< 100,000/µL).

Exclusion criteria :

* Previous therapy (splenectomy, PSE, EVL, tissue adhesive injection, or usage of (NSBB) to prevent rebleeding
* Bleeding from isolated gastric or ectopic varices
* Hepatocellular carcinoma or other malignant tumors
* Contraindications for the use of NSBBs, hepatic failure, and Child-Pugh class C with large amount ascites, or grade 3-5 hepatic encephalopathy, or prothrombin activity ≤ 40%
* Hepatic failure
* Contraindications for PSE
* Pregnancy and lactation
* Inability to sign the informed consent.
Study to Assess Feasibility and Safety of Iron Repletion With Feraheme in Iron Deficient Patients With Durable Ventricular Assist Device Support

Ferumoxytol injection (Feraheme®) is a parenteral form of iron supplementation that is FDA-approved for treatment of iron deficiency anemia. Ferumoxytol injection achieves iron repletion in fewer doses (2) when compared with other available injectable iron formulations (5-6) available at NYU Langone Health, and thus may be useful to reduce travel burden and expedite full iron repletion in patients with iron deficiency. Iron-deficiency anemia is common in patients after placement of a ventricular assist device (VAD) for treatment of end-stage heart disease. This is a pilot study to test the feasibility of iron repletion with ferumoxytol injection in 20 eligible subjects with laboratory evidence of iron deficiency after placement of a VAD.


Eligibility Criteria:
Inclusion Criteria:

* Status post placement of durable ventricular assist device with stable clinical status for \>30days
* Hemoglobin \>6 g/dL AND \<13 g/dL (men) or \<12 g/dL (women) within last 90 days
* Serum ferritin \<100 ng/mL OR Serum ferritin 100-299 ng/mL with transferrin saturation \<20% within last 90 days
* Able and willing to provide written informed consent

Exclusion Criteria:

* Known hypersensitivity to Ferumoxytol injection or other intravenous iron preparation
* History of anaphylaxis
* Treatment with erythropoiesis stimulating agent or intravenous iron in last 3 months
* Renal failure on hemodialysis
* Respiratory failure on mechanical ventilation
* Disabling Stroke
* Ventricular assist device thrombosis
* Evidence of active gastrointestinal bleeding or other active blood loss
* Hospitalization \<30 days
* Pregnant or breastfeeding women