cyrilzakka/clinical-trials huggingface dataset:
The Effects of Acupressure on Pain, Swelling and Comfort in Patients With Femoral Fracture Surgery

Pain is a subjective and unpleasant sensory and emotional experience associated with actual or potential tissue damage. Fractures result from a disruption in the continuity of bone, where bones are subjected to traction, twisting, or compression, causing damage to the surrounding muscular tissues. The treatment of displaced or complex fractures typically requires internal fixation surgery. 89% of fracture patients experience postoperative pain and swelling by the second day following open reduction and internal fixation surgery. These negative sensations can lead to increased pain, limb deformity, and neurovascular compression injuries. If postoperative pain is not adequately managed, it can affect wound healing, increase metabolism and oxygen consumption, and place additional strain on cardiopulmonary function. It is necessary to integrate alternative, non-pharmacological, non-invasive pain relief measures. Effectively and safely alleviating acute postoperative pain can enhance comfort, promote early mobilization, improve adherence to postoperative physical therapy, enhance quality of life and shorten hospital stays.


Eligibility Criteria:
Inclusion Criteria:

1. The patient was hospitalized due to injuries from an accident, diagnosed with unilateral femoral fracture and underwent open reduction internal fixation surgery, hemiarthroplasty, and total hip arthroplasty.
2. Adults aged 18 years or older.
3. Conscious and able to communicate in Mandarin or Taiwanese (Min Nan).
4. Intact and without missing lower limbs.
5. Willing to sign the informed consent form after being briefed on the study objectives and procedures.

Exclusion Criteria:

1. Diagnosis of musculoskeletal tumors.
2. History of cerebrovascular accident or peripheral vascular neuropathy.
3. Major medical conditions such as cirrhosis, renal failure, heart failure, cancer, and severe brain diseases.
4. Edema caused by nutritional deficiency or mucinous causes.
5. Pregnant or lactating women.
6. Patients using patient-controlled analgesia post-surgery.
7. Severe psychiatric disorders or perceptual disorders.
8. Platelet count less than 20 x 10\^3/uL before screening.
9. Albumin less than 3.5g/dL before screening.
10. Individuals closely related to the trial personnel, such as immediate family or dependents of the principal investigator.
Swiss 2024 Continous Fever Monitoring in Pediatric Oncology Patients

In children and adolescents undergoing chemotherapy for cancer, fever in neutropenia (FN) is the most frequent potentially lethal complication of chemotherapy for cancer. Emergency hospitalization and empirical treatment with i.v. broad-spectrum antibiotics have reduced lethality from \>50% in certain high risk situations to \<1%. Fever without neutropenia is a further complication requiring emergency evaluation and often emergency treatment.

Continuous monitoring of fever leads to earlier fever detection compared to the usual discrete fever measurements performed only for clinical reasons. Earlier detection of fever leads to earlier assessment and treatment and thus can reduce the risk of complications.

This study primarily aims to assess, in pediatric patients undergoing chemotherapy for cancer, the efficacy of automated fever alerts resulting from continuous fever monitoring (CFM) using a wearable device (WD), measured by the duration of intravenous antibiotics (i.v. AB) given for any cause.

Primary objective

The primary objective of this study is to determine if CFM fever alerts (CFM-FA) automatically sent by a WD reduce the duration of i.v. antibiotics application in children and adolescents treated with myelosuppressive chemotherapy for cancer.

Secondary objectives

Regarding safety

A. Number of fever episodes (FE) with safety relevant events (SREs)

B. Number of false alerts

C. Number of missed alarms

Regarding efficacy

D. Delay of chemotherapy application

E. Duration of antimicrobial application except i.v. antibiotics

F. Number of FEs diagnosed below or at temperature limit (TL) versus above TL

G. FEs according to chemotherapy intensity

H. WD measured core temperature at time of fever detection by ear thermometer

I. FEs reported outside TARs

J. Quality of life Questionnaire

K. Assessment of the side-effects of the WD

Tertiary objective

L. Comparison of continuously recorded core temperature of the WD with results of discrete measurements of tympanic temperature

M. Pattern search using data mining

Eligibility Criteria:
Inclusion Criteria:

* Chemotherapy treatment because of any malignancy expected to last ≥2 months at time of recruitment for myelosuppressive therapy, or at least 1 cycle of myeloablative chemotherapy followed by hematopoietic stem cell transplantation
* Age ≥1 month and \<18 years at time of recruitment
* Written informed consent from patients and/or parents

Exclusion Criteria:

* Neonates \<1 months
* Local skin disease prohibiting wearing of the WD
* Denied written informed consent from patients and/or parents
* Inclusion of vulnerable participants mandatory as vital signs and FN episodes differ significantly in children and adults
Treosulfan-TMI Conditioning and Rapamycin GvHD Prophylaxis Before Allo-HSCT

TrRaMM-TMI is a phase I trial to evaluate the feasibility and efficacy of an original sequential TMI/TrRaMM (Total Marrow Irradiation/Treosulfan-Rapamycin-Mycophenolate Mofetil) schedule in patients with hematological malignancies in advanced stage of disease undergoing an allogenic Stem Cell Transplant (SCT).

The aim is to determine the maximum tolerated dose of TMI when combined with conditioning chemotherapy to transplant according to TrRaMM schedule.


Eligibility Criteria:
Inclusion Criteria:

* Patients with haematological malignancies such as

  * any acute myeloid leukemia (AML) beyond Complete Remission (CR) 1
  * any acute lymphoblastic leukemia (ALL) beyond CR1
  * multiple myeloma (MM) at any relapse/progression, except refractory disease
  * MM with unfavourable cytogenetic profile at diagnosis
  * MM with less than a partial response (PR) after induction therapy
* Karnofsky Index ≥ 80 %
* Adequate contraception in female patients of child-bearing potential.
* Written informed consent
* Availability of one of the following:

  * A matched related or unrelated donor (MRD or MUD)

Exclusion Criteria:

* A hematopoietic cell transplantation-specific comorbidity index \> 4
* Active non-controlled infectious disease at the moment of inclusion
* Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
* Impaired liver function (Bilirubin \> 2.0 x upper normal limit; Transaminases \> 3.0 x upper normal limit)
* Impaired renal function (Creatinine-clearance \< 60 ml/min; Serum Creatinine \> 1.5 x upper normal limit).
* Pleural effusion or ascites \> 1.0 L
* Pregnancy or lactation
* Known hypersensitivity to treosulfan and/or fludarabine and/or rapamycin
* Non-co-operative behaviour or non-compliance
* Psychiatric diseases or conditions that might impair the ability to give informed consent
* Previous spinal cord radiotherapy with dose ≥ 45 Gy equivalent
Mortality in Free-fall Trauma Patients

In this study, the investigators aimed to analyze the demographic characteristics, patterns of injury, and mortality after free fall in the emergency department of the National Taiwan University Hospital, and the affiliations, Hsin-Chu branch, and Yun-lin branch.

Falls from a height are the leading cause of accidental deaths. The mechanism of free-fall injury is abrupt vertical deceleration and the severity is dependent on the height, body weight, posture and contact area...etc. Most victims presented to the emergency department with major trauma, so initial evaluation and management are crucial for survival. The knowledge of the unique pattern of injuries helps clinicians to facilitate the diagnosis.

Eligibility Criteria:
Inclusion Criteria:

patients aged more than 20 years after free falls in the emergency department of the National Taiwan University Hospital, and the affiliations, Hsin-Chu branch, and Yun-lin branch.

Exclusion Criteria:

patients aged less than 20 years after free fall in the emergency department of the National Taiwan University Hospital, and the affiliations, Hsin-Chu branch, and Yun-lin branch.
Safety and Efficacy of Repeated Administrations of NurOwn® in ALS Patients

This study will evaluate the safety and efficacy of repeated administration of NurOwn® (MSC-NTF cells) therapy, which is based on transplantation of autologous bone marrow derived mesenchymal stromal cells (MSC), which are enriched from the patient's own bone marrow, propagated ex vivo and induced to secrete Neurotrophic factors (NTFs).

The autologous NurOwn® (MSC-NTF cells) are back-transplanted into the patient intrathecally by standard lumbar puncture where neurons and glial cells are expected to take up the neurotrophic factors secreted by the transplanted cells

Neurotrophic factors (NTFs) are potent survival factors for embryonic, neonatal, and adult neurons and are considered potential therapeutic candidates for ALS. Delivery of multiple NTFs to the immediate environment of afflicted neurons in ALS patients is expected to improve their survival and thus slow down disease progression and alleviate symptoms. NTF-secreting mesenchymal stromal cells (MSC-NTF cells) are a novel cell-therapeutic approach aimed at effectively delivering NTFs directly to the site of damage in ALS patients.

Participants meeting the inclusion and exclusion criteria will be randomized and will undergo bone-marrow aspiration. MSC of the participants randomized to the treatment group will be induced into MSC-NTF cells. Participants will undergo a total of three intrathecal (IT) transplantations with NurOwn® (MSC-NTF cells) or matching placebo at three bi-monthly intervals

Eligibility Criteria:
Inclusion Criteria:

* ALS diagnosed as possible, laboratory-supported probable, probable, or definite as defined by revised El Escorial criteria.
* Having onset of ALS disease symptoms, including limb weakness within 24 months at the Screening Visit.
* ALSFRS-R ≥ 25 at the screening Visit.
* Upright slow vital capacity (SVC) measure ≥ 65% of predicted for gender, height, and age at the screening Visit.
* Rapid progressors
* Participants taking a stable dose of Riluzole are permitted in the study
* Citizen or permanent resident of the United States or Canadian citizen able to travel to a US site for all follow-up study visits

Exclusion Criteria:

* Prior stem cell therapy of any kind
* History of autoimmune or other serious disease (including malignancy and immune deficiency) that may confound study results
* Current use of immunosuppressant medication or anticoagulants (per Investigator discretion)
* Exposure to any other experimental agent or participation in an ALS clinical trial within 30 days prior to Screening Visit
* Use of RADICAVA (edaravone injection) within 30 days of screening or intent to use edaravone at any time during the course of the study including the follow up period
* Use of non-invasive ventilation (BIPAP), diaphragm pacing system or invasive ventilation (tracheostomy)
* Feeding tube
* Pregnant women or women currently breastfeeding
Study of Yoga as a Therapy for Cystic Fibrosis (CF) Patients

Cystic fibrosis (CF) is a lung disease that affects 30,000 children and adults in the US. Incorporation of regular exercise into the lives of patients with CF is of interest because it may improve lung function and quality of life. Yoga is an activity that may benefit patients with CF in many ways including strengthening muscles of breathing, improving lung function, and reducing stress which could improve quality of life and adherence to therapies. Yoga has been shown to be beneficial in patients with other lung diseases such as asthma, but has not yet been studied in CF.

The investigators hypothesize that yoga will be an activity that is safe and tolerable for CF patients 12 to 25 years of age. The primary aim is to investigate the safety and tolerability of an 8 week yoga program for patients with CF. The secondary aim is to determine the effect of yoga on many aspects of CF disease including respiratory symptoms, adherence to regular CF therapies, quality of life, lung function, exercise tolerance, and nutritional status.

The long-term goal is to use the data obtained in this study to design a future study of the efficacy of yoga in a larger population of CF patients at multiple CF centers. This research has the potential to influence the prevention and treatment of CF by providing data which could be used to help understand the most appropriate and beneficial type of physical activity for CF patients.


Eligibility Criteria:
Inclusion Criteria:

o Diagnosis of CF by: Sweat chloride ≥60meq/L on two occasions or CFTR genotype with two CF disease-causing mutations and one or more phenotypic features of CF

* Age ≥12 and ≤25 years
* FEV1 ≥40 % predicted at screening visit
* Informed consent and assent

Exclusion Criteria:

* Wheezing on auscultation of the chest at the enrollment visit
* Oxygen saturation \< 90 % at the enrollment visit
* Initiation of treatment with oral, inhaled or intravenous antibiotics for an acute respiratory infection in the 2 weeks preceding the enrollment visit
* Pregnancy
* History of lung transplant
* Practiced yoga regularly (≥1 time per week) in the month prior to enrollment
* Current enrollment in a therapeutic clinical trial
* Condition or situation which, in the opinion of the investigator, would affect the ability of the patient or family to complete study procedures
Prospective Evaluation of Programmed Ventricular Stimulation Before Pulmonary Valve Replacement in Patients With Tetralogy of Fallot

Severe pulmonary regurgitation is common in patients with Tetralogy of Fallot and results in progressive right ventricular dilatation and dysfunction. Pulmonary valve replacement is frequent in this population, and percutaneous procedures are increasing.

Ventricular arrhythmias are a frequent late complication in patients with tetralogy of Fallot. The most common critical isthmus of ventricular tachycardias is between the pulmonary valve and the ventricular septal defect patch.

While an electrophysiology study is sometimes performed in expert centers before surgical pulmonary valve replacement to guide a surgical ablation if needed, this approach is not recommended in current guidelines. An electrophysiology study should also be considered before percutaneous pulmonary valve replacement, as a part of the critical isthmus may be covered by the prosthetic pulmonary valve. Moreover, ablation after percutaneous pulmonary valve insertion exposes patients to the risks of traumatic valve or stent injury and infectious endocarditis.

At present, reliable predictors to identify high-risk patients in whom an electrophysiology study should be performed before pulmonary valve replacement are lacking.

The aim of this study is to assess prospectively the yield of systematic electrophysiology study and programmed ventricular stimulation before surgical and percutaneous pulmonary valve replacement in patients with tetralogy of Fallot.


Eligibility Criteria:
Inclusion Criteria:

* All patients with repaired tetralogy of Fallot referred for surgical or percutaneous pulmonary valve replacement

Exclusion Criteria:

* Absence of patient's consent
Efficacy of Hypnotherapy in Children With Dental Anxiety

Dental anxiety is a common problem among the children. The aim of this study is to evaluate the efficacy of hypnotherapy in children with dental anxiety. The participants will be randomized in a 1:1 ratio to hypnotherapy or control group. The outcome measures will be Modified Children Dental Anxiety Scale-faces version(MCDAS(f)) and Visual Analogue Scale(VAS).


Eligibility Criteria:
Inclusion Criteria:

* initial MCDAS(f) total score \> 19
* ICDAS II (international caries detection and assessment score)= 5 for at least one tooth

Exclusion Criteria:

* presence of dental pain complaint
* non-obtaining the informed consent form
Host RNA Expression Profiles and Protein Biomarkers in Neonatal Herpes Simplex Virus Infection

This study seeks to identify and test host RNA expression profiles in context to protein biomarkers in dried blood spot samples as novel diagnostic markers of neonatal herpes simplex virus infection and to improve the understanding of the pathogenesis of the disease.

Background:

Herpes Simplex Virus (HSV) infection in newborns is uncommon but can be devastating and is associated with significant morbidity and mortality. The diagnosis of neonatal HSV infection is challenging because maternal genital herpes often is asymptomatic and the clinical presentation in newborns can be nonspecific, especially in the early disease stages. This results in late diagnosis and potentially terrible consequences for the newborn. The reason why some newborns develop severe disease due to HSV infection is unknown. It has been suggested that immunologic differences in early infancy are the key to further advances. Host RNA expression profiling, transcriptomics, of the host response to infections has shown great potential as clinical tool for diagnostics and for unveiling molecular disease mechanisms. As previously shown, reliable host RNA expression data can be obtained from neonatal dried blood spot (DBS) samples by RNA-sequencing. Proteomic analysis has the potential to simultaneously identify hundreds of protein biomarkers and immune cell populations allowing for detailed mapping of disease immunological pathways.

Method:

A nationwide retrospective case-control study of all newborns with HSV infection in Denmark from 2010 through 2019. DBS samples will be obtained from the Danish Neonatal Screening Biobank, Statens Serum Institut. RNA sequencing and proteomic analyses will be performed at the Danish Center for Neonatal Screening, Department of Congenital Disorders, Statens Serum Institut. Cases will be randomly assigned to a "Discovery cohort" and compared to a control group of newborns matched on gestational age, sex and birthweight will be included.

Time frame:

Sample identification/recruiting: January 1st to January 31st 2022. Sample analysis (RNA sequencing and proteomic analysis): February 1st to April 30th 2022.

Perspectives:

New molecular-based diagnostic tools complementary to conventional methods may improve early diagnosis of neonatal HSV infections and lead to optimised management. In addition, understanding of the pathogenesis at a molecular level of severe disease manifestations of the disease, could form the basis for development of novel interventions for better prevention and treatment.

Eligibility Criteria:
Inclusion Criteria:

1. cases of newborns aged 0-28 days with verified HSV infection (positive HSV PCR in blood, cerebrospinal fluid and/or swab sample)
2. controls of newborns without infection matched on gestational age, sex and birthweight

Exclusion Criteria:

1. dried blood spot samples that are not allowed to be used for research
2. dried blood spots samples containing insufficient amount of blood for research
of Sodium Glucose Cotransporter-2 Inhibitors on Metabolic, Hormonal and Clinical Parameters in PCO

The aim of this study is to compare the hormonal, metabolic and clinical effects of metformin and dapagliflozin as monotherapies and the effect of both of them as a combined therapy in infertile women with PCOs.

It is a Prospective randomized controlled trial .The study will include 200 randomly selected infertile women aged between 18 and 45 years, from Gynecology and obstetrics department Beni-Suef University Hospital whom diagnosed with polycystic ovarian syndrome (PCOS), according to Rotterdam criteria (BMI≥ 24kg/m, Homeostatic model assessment of insulin resistance (HOMA-IR with cutoff ≥ 2.5 biochemical hyperandrogenism, as indicated by a free androgen index (FAI) \>4, and self-reported oligomenorrhea (cycle length \>35 days and 9 or fewer periods per year) or amenorrhoea (absence of menses for a period ≥3 months) will be included for the study.

I The study will include four groups; each group consists of 50 patients:-

* Group I (n=50) will be treated by metformin monotherapy.
* Group II (n=50) will be treated by Dapagliflozin monotherapy .
* Group III (n=50) will be treated by metformin and dapagliflozin combined therapy
* Group IV (n=50) will be a control group.

Eligibility Criteria:
Inclusion Criteria:

* Women are aged between 18 and 45 years
* no pregnancy plan within the next 6 months
* polycystic ovarian syndrome (PCOS), according to Rotterdam criteria

Exclusion Criteria:

1. congenital adrenal hyperplasia
2. poorly controlled thyroid disease
3. Taking antidiabetic drugs which can affect insulin resistance
4. chronic kidney disease and history of recurrent urinary tract infections
5. liver dysfunction (AST or ALT \> 3 times the upper limit of normal or GFR\<30 ml/min/1.73m2)
6. documented use of oral hormonal contraceptives and hormone-releasing implants
Randomized Evaluation of Radotinib Versus Imatinib in Phase III Study for Efficacy With Chinese Patients (RERISE China)

This is a Phase III, multi-center, open-label, parallel, 2-arm, randomized study to evaluate the efficacy and safety of radotinib 300 mg Bis In Die(BID) versus imatinib 400 mg Quaque Die(QD).

This study will be conducted in Chinese patients with newly diagnosed Ph+ Chronic Myelogenous Leukemia(CML)-Chronic Phase(CP) who are previously untreated for Chronic Myelogenous Leukemia(CML).

Patients randomized to the radotinib arms will receive 300 mg of radotinib BID at approximately 12-hour intervals. Patients randomized to the imatinib 400 mg arm will receive imatinib once a day throughout the study.

The primary efficacy endpoint is the rate of Major Molecular Response(MMR) at 12 months (1 month = 4 weeks = 28 days), defined as BCR ABL1/ABL% ≤ 0.1% by international scale. The Molecular Response(MR) rate will be measured every 3 months by Real-time Quantitative(RQ)-Polymerase Chain Reaction(PCR) in a central laboratory. All patients will be treated and/or followed for 12 months (48 weeks) after randomization.

Eligibility Criteria:
Inclusion Criteria:

1. China who are 18 years of age or older.
2. Eastern cooperative oncology group (ECOG) score 0, 1, or 2.
3. Patients with confirmed diagnosis of CML-CP within last 6 months.
4. Patients with cytogenetically confirmed Ph+ CML in chronic phase
5. Patients with typical BCR-ABL1 transcript type such as b2a2 and b3a2.
6. Patients with adequate organ function.
7. Women of childbearing potential should have negative serum or urine pregnancy test within 14 days before study entry.
8. Patients providing written informed consent before initiation of any study-related activities.

Exclusion Criteria:

1. Patients with Philadelphia chromosome negative but BCR-ABL1 positive CML.
2. Patients who had been treated with interferon or other targeted anti-cancer therapy which inhibits the growth of leukemic cells
3. Concurrently clinically significant primary malignancy
4. Patients who previously received radiotherapy
5. Patients with impaired cardiac function.
6. uncontrolled chronic medical condition