cyrilzakka/clinical-trials huggingface dataset:
Feasibility and Safety of Using Nasal High Flow Oxygen Postoperatively to Reduce Respiratory Complications

The use of nasal high flow in patients undergoing oesophagectomy is a novel technique that has not been previously studied.

Nasal high flow will be delivered postoperatively to patients undergoing oesophagectomy in a tertiary cancer referral centre. This single-centre cohort study will evaluate the safety of using nasal high flow in oesophagectomy patients. Physiological parameters, adverse events and clinical outcome will be recorded in consecutive patients undergoing oesophagogastric surgery.

This study will challenge the hypothesis that the use of nasal high-flow will lower the rates of breathing complications such as pneumonia thereby reducing the demands on intensive care, shortening hospital stay and improving patient quality of life. The results will inform the design of a larger multicentre clinical trial comparing nasal high flow to conventional methods by facilitating sample size calculation.

Respiratory complications including pneumonia, pleural effusion, adult respiratory distress syndrome and pulmonary embolism will be recorded. The primary endpoint will be the rate of postoperative respiratory complications within 30 days of oesophagectomy. Technical complications related to nasal high flow administration will be recorded and reasons for discontinuing nasal high flow documented. Other outcome including mortality, hospital stay, surgical complications and respiratory complications within 90 days of surgery will be considered as secondary endpoints. These data will assess the feasibility and safety of using nasal high flow in patients undergoing oesophagectomy. The rate of respiratory complications will be determined in a cohort of consecutive surgical patients together with other measures of outcome to form the basis of a series worthy of reporting. This may help gain insight into whether using nasal high flow could benefit patients, and whether further research to compare nasal high flow to conventional respiratory support would be of value.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old
* Undergoing Ivor-Lewis (2-stage) oesophagectomy
* Successfully extubated within 4 hours after surgery

Exclusion Criteria:

* History of bullous emphysematous disease
* Lack of capacity to consent
* Significant air leak during surgery
* Incurable disease found at surgery leading to no surgical resection
* Failure of extubation and spontaneous breathing within 4 hours after surgery
Efficacy and Safety of Asenapine With Placebo and Haloperidol (41023)(P05926)(COMPLETED)

Schizophrenia is a brain disease. The primary features of schizophrenia are characterized by Positive symptoms (symptoms that should not be there, inability to think clearly, to distinguish reality from fantasy i.e., hearing voices) and Negative symptoms (a reduction or absence of normal behaviors or emotions, i.e., unable to manage emotions, make decisions and relate to others). Other symptoms include reduced ability to recall and learn new information, difficulty with problem solving, or maintaining productive employment. The symptoms of schizophrenia may be due to an imbalance in chemicals in the brain, primarily dopamine and serotonin, which enables brain cells to communicate with each other.

Asenapine is an investigational drug that may help to correct the inbalance in dopamine and serotonin. This is a 6-week trial to test the efficacy and safety of asenapine, compared with placebo, using an active comparator agent (haloperidol) in the treatment of patients with an acute exacerbation of schizophrenia. Patients who complete the 6-week trial will have the option of continuing in an additional one year extension trial.


Eligibility Criteria:
Inclusion Criteria:

* Currently suffering from an acute exacerbation of schizophrenia. Caregiver required.

Exclusion Criteria:

* Have an uncontrolled, unstable medical condition. Have any other pyschiatric disorder other than schizophrenia as a primary diagnosis.
The Effect of Simple Gymnastics Training for Parkinson's Patients in the Community

The goal of this clinical trial is to explore the impact of Simple Gymnastics Training on Limb motor function and mental health in Parkinson's Patients in the Community (≥60 year old) with swallowing disorders. It primarily aims to address two key aspects: 1) the prevalence of Parkinson's Diseases among community-dwelling elderly individuals, and 2) the effects of Simple Gymnastics Training on Limb motor function and mental health in community-dwelling Parkinson's Patients. All patients are required to undergo a continuous three-week (21 days) Simple Gymnastics Training, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 30 minutes each.

In the early stages of Parkinson's disease, many patients do not seek medical attention. The goal of this clinical trial is to explore the impact of Simple Gymnastics Training on Limb motor function and mental health in Parkinson's Patients in the Community (≥60 year old) with swallowing disorders. It primarily aims to address two key aspects: 1) the prevalence of Parkinson's Diseases among community-dwelling elderly individuals, and 2) the effects of Simple Gymnastics Training on Limb motor function and mental health in community-dwelling Parkinson's Patients. All patients are required to undergo a continuous three-week (21 days) Simple Gymnastics Training, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 30 minutes each.

Eligibility Criteria:
Inclusion Criteria:

* Age \>60 years.
* Meeting the diagnostic criteria for Parkinson's disease developed by the Neurology Branch of the Chinese Medical Association in 2006.

Exclusion Criteria:

* Complicated with cognitive impairment or consciousness dysfunction.
* Simultaneously suffering from severe liver, kidney failure, tumors, or hematological diseases.
* Complicated with severe liver and kidney failure, tumors, or hematological disorders.
Dynamic Assessment of Right Ventricular Function With Inhaled Nitric Oxide During Cardiac MRI

The purpose of the study is to measure RV ejection fraction (RVEF), pulmonary flow, and pulmonary perfusion before and after exposure to inhaled nitric oxide in patients with pulmonary arterial hypertension (PAH) who are known to be vasodilator-responsive based on invasive catheterization as well as healthy subjects. Measurements will also be made after high flow oxygen alone to test the relative vasodilatory effect of oxygen and NO. The investigators hypothesize is that inhaled nitric oxide during cardiac MRI can be used to measure dynamic changes in RV-pulmonary vascular function in patients with vasodilator-responsive PAH.


Eligibility Criteria:
Inclusion Criteria:

* Patients age 18 or older of the Vanderbilt Center for Pulmonary Vascular Disease. Vasodilator-responsive patients will be identified based on prior response to inhaled nitric oxide during invasive right heart catheterization
* Healthy subjects age 18 or older not known to have cardiopulmonary disease

Exclusion Criteria:

* Standard conventional contraindications for cardiac magnetic resonance (CMR) imaging
* Allergy or contraindication to Magnevist (gadopentetate dimeglumine) contrast
* Concurrent intravenous epoprostenol infusion in whom performance of CMR is cumbersome
* Pregnant women
A Study of Real Life Treatment for Multiple Myeloma (MM)

The main aim of this study is to learn how long it takes for people with MM to have a relapse after their first treatment. Not all participants will have a relapse during the study.

Participants will visit their clinic every 3 months and be treated according to their clinic's standard practice.

The study sponsor will not be involved in how participants are treated but will provide instructions on how the clinics will record what happens during the study.

This is a non-interventional, prospective study of participants with MM relapses. This study will assess the low detection rate of biochemical relapses which will improve routine clinical practices and management of participants with MM in real world practice.

The study will enroll approximately 350 participants. The data will be collected both prospectively and/or retrospectively at the specialized care (hematology) and will be recorded into electronic case report forms (e-CRFs) of the electronic data capture (EDC) system. All the participants will be assigned to a single observational cohort:

• Participants With MM

This multi-center study will be conducted in the Russian Federation. The overall duration of the study will be approximately 4 years. The overall time for treatment and follow-up period will be approximately 2.5 years for each participant.

Eligibility Criteria:
Inclusion Criteria:

1. With newly diagnosed multiple myeloma (NDMM) eligible and non-eligible for a high-dose therapy and autologous stem cell transplantation (HDT-ASCT) who have had a response (defined as CR, VGPR, or PR) to the ongoing SoC induction (1st line) therapy that has been started within 3 months before the inclusion.
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 at the time of inclusion.

Exclusion Criteria:

1. With NDMM eligible and non-eligible for a HDT-ASCT who have had SD or PD to the ongoing standard of care (SoC) induction (1st line) therapy that has been started within 3 months before the inclusion.
2. Current, previous (within the last year) or planned (for the next 15-20 months) participation in interventional clinical trial.
Exercise in Pediatric Autologous Stem Cell Transplant Patients

Hematopoietic stem cell transplantation is an intensive therapy used to improve survivorship and cure various oncologic diseases. However, this therapy is associated with high mortality rates and numerous negative side-effects. The recovery of the immune system is a special concern and plays a key role in the success of this treatment. In healthy populations it is known that exercise plays an important role in immune system regulation, but little is known about the role of exercise in the hematological and immunological recovery of children undergoing hematopoietic stem cell transplant. The Primary objective of this Randomized Controlled Trial is: study the effect of an exercise program on immune cell recovery in patients undergoing autologous stem cell transplantation. The Secondary objective is to determine if an exercise intervention might diminish the deterioration of quality of life, physical fitness, and the acquisition of a sedentary lifestyle.

Methods

Twenty-four participants treated for a malignancy with autologous stem cell transplant (5 to 18 years) in the Alberta Children's Hospital will be randomly assigned to an exercise or control group. The exercise group will participate in a two-phase exercise intervention (in and outpatient) from hospitalization until 10 weeks after discharge. The exercise program includes strength, flexibility and aerobic exercise. During the inpatient phase this program will be performed 5 times/week and will be supervised. The outpatient phase will combine a supervised session with two home-based exercise sessions with the use of the Wii device. The control group will follow the standard protocol without any specific exercise program. A range of outcomes, including quantitative and functional recovery of immune system, cytokine levels in serum, NK cells and their subset recovery and function, and gene expression of activating and inhibitory NK cell receptors, body composition, nutrition, quality of life, fatigue, health-related fitness assessment and physical activity levels will be examined, providing the most comprehensive assessment to date.

Discussion We expect to find an improvement in the immunological recovery, quality of life, decreased acquisition of sedentary behavior and less fitness deconditioning.


Eligibility Criteria:
Inclusion Criteria:

* autologous SCT at Alberta Children's Hospital (ACH) for malignancy
* age 5 to 18 years of age
* will be receiving myeloablative conditioning regimen
* no evidence of cardiac or pulmonary failure associated with treatment (SF≥28%, EF ≥ 50%)
* no functional nor cognitive limitation that would prohibit performance of the home-based training
* approval by treating oncologist for participants
* a parent or legal guardian must sign the consent form and
* children should express verbal assent to participate.

Exclusion Criteria:

-
A Study to Compare the Pharmacokinetics of Fimasartan/Atorvastatin Combination Tablet

A phase I, Open-label, Randomized, Single-dose, 2 x 2 Crossover Study to Compare the Pharmacokinetics of Fimasartan/Atorvastatin Combination Tablet and Coadministration of Fimasartan and Atorvastatin as Individual Tablets in Healthy Male Volunteers.


Eligibility Criteria:
Inclusion Criteria:

* a Healthy male subject, aged 19- 50 years

Exclusion Criteria:

* History of clinically significant hypersensitivity to study drug, any other drug
* Hypotension or hypertension
* Active liver disease
* History of gastrointestinal disease
* History of excessive alcohol abuse
* Participation in any other study within 3 months
The Relationship Between Umbilical Cord Coiling Index and Fetal Cardiac Functions.

The maximum efficiency of umbilical cord blood flow depends on a specific number of coils. With modern ultrasound techniques, investigators can now detect cord abnormalities even before birth. In recent years, there has been a renewed interest in the umbilical cord, and several articles have been published regarding the number of coils.In this study, the relationship between the umbilical cord coiling index and fetal cardiac functions was evaluated.


Eligibility Criteria:
Inclusion Criteria:

-Singleton uncomplicated pregnancies between 20-24 weeks seeking routine antenatal care.

Exclusion Criteria:

* Multiple pregnancy
* Preterm rupture of membranes
* Chorioamnionitis
* Placental abruption
* Severe fetal growth restriction
* Congenital anomalies of the fetus
* Preeclampsia
* Oligohydramnios
* Maternal diabetes.
Alefacept for Chronic Graft Versus Host Disease

Alefacept (AMEVIVE®) is an immunosuppressive dimeric fusion protein that consists of the extracellular CD2-binding portion of the human leukocyte function antigen-3 (LFA-3) linked to the Fcof IgG1. Alefacept is produced by recombinant DNA technology in a Chinese Hamster Ovary (CHO) mammalian cell expression system. It was shown to interfere with lymphocyte activation. Alefacept was evaluated in two randomized, double-blind, placebo-controlled studies in adults with chronic plaque psoriasis. Each course consisted of once-weekly administration for 12 weeks of placebo or alefacept. The response to alefacept was significantly better in both studies. In both studies, onset of response to alefacept treatment (defined as at least 50% reduction of baseline Psoriasis Area and Severity Index (PASI)) began 60 days after the start of therapy. With one course of therapy, the median duration of response (defined as maintenance of a 75% or greater reduction in PASI) was 3.5 months for alefacept treated patients and 1 month for placebo-treated patients. Most patients who had responded to either alefacept or placebo maintained a 50% or greater reduction in PASI through the 3-month observation period.

Graft versus host disease (GVHD) is the most ominous side effect of allogenic stem cell transplantation (SCT). It causes severe inflammatory process, which is usually located to the skin, gut and liver. Treatment of GVHD consists of various immuno-suppressive and immuno-modulating drugs, including steroids, cyclosporine, tacrolimus, methotrexate etc. These drugs unfortunately can also cause severe immunologic failure that makes the patient prone to infection and malignancy, and other medication-specific side effects. In spite of this effect on the immune system, not all of the patients achieve control of GVHD, which usually rapidly leads to death. Despite the use of innovative immunosuppressive modalities, the prognosis of steroid resistant GVHD is usually poor. In the following study we will evaluate the effect of alefacept on steroid unresponsive cGVHD.


Eligibility Criteria:
Inclusion Criteria:

* No age limit
* Resistant chronic GVHD

Exclusion Criteria:

* Not fulfilling any of the inclusion criteria
* Active life-threatening infection
* Inability to comply with study requirements.
* Known hypersensitivity to alefacept.
* Active malignant disease
Neuroimaging of Opioid Phase (OPAL)

The purpose of this study is to compare activity in the brains of female adults with chronic pain and/or opioid use, and healthy female adults that may help to develop new and targeted treatments for adults with chronic pain and alternatives to opioid therapy.

The objective of the study is to determine differences in neurophysiology and behavior during different phases of opioid use in patients. Study activities will include neuroimaging (MRI and fMRI), behavioral tasks, sensory testing, blood draws, and questionnaires. The neuroimaging data will be analyzed using specialized software; data from questionnaires, sensory testing, and behavioral task performance will be analyzed using standard statistical software. Risks and safety concerns include standard, minimal risks associated with MRI scans, sensory testing, blood draws, and confidentiality.

Eligibility Criteria:
Inclusion Criteria for Healthy Controls:

1. female and ages 18+
2. ability to read/understand English and give consent to participate
3. no current or history of chronic pain
4. not regularly taking any pain-relieving or mood-altering medications (per PI discretion)
5. absence of use of opioid medications

Inclusion Criteria for Individuals with Chronic Pain:

1. female and ages 18 +
2. ability to read/understand English and give consent to participate
3. self-reported or physician diagnosis of fibromyalgia and/or chronic pain
4. current use of opioid medication(s) for inclusion in the opioid patient group -OR- absence of use of opioid medications for inclusion in the non-opioid patient group

Exclusion Criteria (for both groups):

1. limited ability to participate fully in behavioral tasks, longitudinal follow-up
2. MRI contraindication
3. any factors that at the discretion of the investigators would adversely affect the participant or the integrity of the study
4. male
Pain Sensitivity Questionnaire Applied in Preoperative Period in Lumpectomy

Objective: The Pain Sensitivity Questionnaire (PSQ) is a clinically valuable tool that has been shown to correlate with various experimental pain sensitivity assessments in healthy individuals and patients with chronic pain. In this study, we aimed to investigate the effectiveness of the PSQ in predicting postoperative pain in patients undergoing breast-conserving surgery.

Objective: The Pain Sensitivity Questionnaire (PSQ) is a clinically valuable tool that has been shown to correlate with various experimental pain sensitivity assessments in healthy individuals and patients with chronic pain. In this study, we aimed to investigate the effectiveness of the PSQ in predicting postoperative pain in patients undergoing breast-conserving surgery.

Materials and Methods: This study included 74 patients over the age of 18 with American Society of Anesthesiologists (ASA) scores of I, II, or III, who were scheduled to undergo breast-conserving surgery. Ethical approval from the local ethics committee and written informed consent from each patient were obtained. Patient data, including age, ASA score, and comorbidities, were collected, and contact details were recorded for postoperative follow-up.

The PSQ was administered to all patients during the preoperative period to assess their pain sensitivity. Anesthesia induction and maintenance followed a standardized protocol on the day of surgery. The intraoperative analgesic consumption and the duration of the surgery were documented. Postoperative assessments were conducted 24 hours after the surgery in the general surgery ward, where analgesic use and short pain inventory scores were recorded. Patients were followed up one month postoperatively, and their pain levels were assessed using the Numeric Rating Scale (NRS).

Eligibility Criteria:
Inclusion Criteria:

Having planned BCS with general anesthesia

* Being a female patient between the ages of 18-70
* Being evaluated as American Society of Anesthesiologists (ASA) I, II, III
* Having given written consent to participate in the study

Exclusion Criteria:

Pregnancy

* Being assessed as ASA IV
* Having advanced cardiac, pulmonary and cerebrovascular disease, advanced renal failure, liver failure, history of fentanyl/remifentanyl hypersensitivity, Alzheimer's disease, mental retardation
* Being at a mental level that cannot comply with the evaluations within the scope of the study
* Not having given written consent for any reason
Study to Evaluate the Physiological Effects on the Skin of 3 Food Supplements Versus Placebo in 40-60 Years Old Female Subjects

The objective is to evaluate the effects on the skin of 3 foods supplements compared to placebo after daily intake for 3 months in female subjects presenting healthy skin.

Skin parameters measured are: the firmness of the skin and other biomechanical skin properties (elasticity, tonicity, density), cellulitis visibility, radiance complexion, skin condition (microrelief, skin barrier function and moisturizing)

Study design: Monocentric, randomized, double blind, placebo controlled, 3 groups in parallel.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Phototype II to IV (Fitzpatrick)
* Visual skin radiance score (face) ≤ 7 (0 to 9 points numeric scale)
* Tactile skin firmness score (cheek) ≤ 7 (0 to 9 points numeric scale)
* Visual cellulite score (thigh) ≥ 3 (0 to 9 points numeric scale)

Exclusion Criteria:

* Chronic pathology or systemic disorder
* Subjects presenting imperfections on the test sites
* Pregnant or who are planning to become pregnant
* Medication or condition that may interfere with tested outcomes
Clinical and Radiographic Evaluation of Zinc Oxide-Propolis Mixture Versus Modified Triple Antibiotic Paste in LSTR

The aim of this study is to evaluate and compare the clinical effectiveness of zinc oxide-propolis mixture with triple antibiotic paste in LSTR as root canal filling material in necrotic primary molars.

The promising results of propolis as a natural antibiotic in previous in- vivo studies made it interesting to combine propolis to the golden standard zinc oxide eugenol as an intracanal medication in pulp affected primary molars and use this mix as a natural substitute to the modified triple antibiotic paste (m-TAP) and therefore overcoming the antibiotic bacterial resistance, allergy and developmental anomalies that might arise in permanent successor teeth from m-TAP usage.

Eligibility Criteria:
Inclusion Criteria:

* Children:

  1. Cooperative children aged 4 -7 years old.
  2. Systemically healthy.
* Teeth:

Clinical criteria:

1. Necrotic primary mandibular second molar teeth.
2. Spontaneous pain or tenderness to percussion
3. Deep carious lesion with pulp exposure.
4. Presence of chronic apical abscess or sinus tract Tooth should be restorable. (Thakur et al., 2021)

Radiographic criteria:

1. Coronal-radiographic evidence of a deep carious lesions or lesion approximating pulp
2. Radicular discontinuity of lamina dura, furcation involvement less than or equal to half of shortest root in vertical dimension. (Thakur et al., 2021)

Exclusion Criteria:

* Children:

  1. With physical or emotional alteration.
  2. Children with systemic disease.
  3. Previous history of allergy to antibiotics used in the study.
  4. Children that will not attend follow up. • Teeth:

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  1. Non restorable carious primary molars.
  2. Grade III mobility