cyrilzakka/clinical-trials huggingface dataset:
Frequency of Vertebrospinal Anomalies in Patients Presenting With Anorectal Malformations

To determine the frequency of different vertebrospinal anomalies in patients with ARM

106 pediatric patients presenting in Department of Neonatal and Paediatric Surgery, The Children Hospital, PIMS from date of approval up to 6 months with diagnosis of anorectal malforatioms will be enrolled in the study using non-probability convenience sampling technique. In this way, 106 patients will be included in the study. Patient selection will be made in the light of aforementioned exclusion and inclusion criteria of the study. Guardians of all patients will be explained about the study and informed consent will be obtained from them. Baseline data of enrolled patients will be recorded in the clinical questionnaire after careful history and examination. All patients born in our setup go through initial Xray of Lumbar spine and sacrum and ultrasound of spine which will be observed. Findings in the imaging will be noted in the clinical performa. It will be ensured that data is collected after approval of the synopsis and patient's confidentiality would not be breeched. Patients would have the autonomy to withdraw from study whenever they want.

Eligibility Criteria:
Inclusion Criteria:

* I.Neonates and Paediatric patients from age 1 day to 12 years II.Presenting in Department of Paediatric Surgery with Anorectal Malformation III.Both Pre and Post Op

Exclusion Criteria:

* Patients who have not consented for further investigations
A Prospective Patient Reported Outcomes and Wearables Study in Myeloproliferative Neoplasms

The investigators will assess the use of a smart phone app to monitor patient reported outcomes and record biometric data in patients with myeloproliferative neoplasms.

To determine whether the development of a dedicated myeloproliferative neoplasm (MPN) smartphone application is of benefit to MPN patients and shows utility for medical professionals to explore efficient disease management through retrieval of 'real-world' patient data.

1. To Track Symptoms and Provide Easy Access to Information: The core focus of the project is to enhance the quality of life for people with MPNs. The app will serve as a comprehensive toolkit to help people with MPNs proactively monitor and track their symptoms, leading to improved self-care. The App will also provide direct access to reliable, up-to-date information about MPNs, empowering users to better understand their condition and make well-informed decisions regarding their health.
2. To Contribute to Research: The app will actively contribute to MPN research by generating valuable patient-generated real-world data to inform clinical trials, treatment development, and disease understanding. Currently, most of the clinical information and data in this patient population comes from clinical trials and major academic centres. As such, there is a significant gap in recording practice and outcomes in other areas, which likely makes up a large proportion of the total patient population. The app would provide a means of monitoring patient experience, comorbidities, treatments, and outcomes, as well as highlighting unmet needs in this under-represented patient group.

A 5-year sub-study using wearables is also planned to explore symptom management and collect biometric data to assess how this correlates with symptom burden, disease specific outcomes, treatment response and quality of life. The app's data collection capabilities have the potential to revolutionize the research landscape for MPNs. By collecting large volume data from this patient group, researchers will be able to assess trends in treatment response, biomarker identification and allow optimisation of therapeutic pathways and improve design of clinical trials. This could lead to the development of new treatments being made more widely available to patients and potentially improve the lives of this patient population.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of MPN.
2. Resident in the UK
3. Aged 18 years and over.
4. Able to confidently converse in English language.
5. Access to smartphone/ mobile phone.
6. Capable of providing informed consent.
7. Physically able to stand and ambulate independently (for substudy).

Exclusion Criteria:

* Patients with a known allergic reaction to any materials in the wearable device (substudy).
* Patients who for any reason are not able to have a wearable (substudy). For example Withings ScanWatch should not be be used if the patient has an implantable electronic device such as a pacemaker or implantable cardioverter-defibrillator
Evaluation of the Clinical Performance of the Quantra System With the QStat Cartridge

This pilot study will evaluate the performance of the Quantra System comprised of the Quantra Hemostasis Analyzer with the QStat Cartridge in trauma patients or patients with OB hemorrhage.

The Quantra System is a fully integrated and automated in vitro diagnostic device which uses SEER Sonorheometry, an ultrasound-based technology, to characterize the viscoelastic properties of a whole blood sample during coagulation. The QStat Cartridge was developed to monitor hemostasis in patients that may experience a range of coagulopathies of various etiologies including fibrinolytic defects. These patients include the trauma and obstetric hemorrhage populations. The cartridge consists of four independent channels each containing different sets of reagents, which provide four measurements performed in parallel yielding five parameters that depict the functional status of a patient's coagulation system.

This single-center, prospective, observational pilot study will evaluate the performance of the Quantra System with the QStat Cartridge as compared to standard coagulation tests and comparable measures using conventional viscoelastic testing methods.

Eligibility Criteria:
Inclusion Criteria:

* Subject is ≥ 18 years of age
* Subject has one of the following conditions and is a candidate for a ROTEM test to be performed to access coagulopathy: trauma patient; patient with OB hemorrhage.

  * For trauma patients; subject must be experiencing major trauma (preferably requiring the highest level of team activation) with active bleeding or deemed at high risk of significant bleeding according to mechanism of injury.
  * For subjects experiencing OB hemorrhage, one of the following conditions must be met (to be confirmed):

    * Estimated blood loss during vaginal delivery is greater than 1000 mL
    * Estimated blood loss during cesarean delivery is greater than 1500 mL
    * Placental abruption with hemorrhage of any quantity blood loss
    * Clinically suspected disseminated intravascular coagulation (DIC)
    * Is under consideration for administration of tranexamic acid (TXA) for treatment of hemorrhage.
* Subject is willing to participate, and is willing to consent (either prospectively or by deferred consent)

Exclusion Criteria:

* Subject is younger than 18 years of age
* Subject is known to have received antifibrinolytic therapy immediately prior to presentation to trauma unit or during labor just prior to OB hemorrhage.
* Subject is unable to provide written informed consent (either prior to performing any study related procedures or by deferred consent)
* Subject is currently enrolled in a distinct study that might confound the results of the proposed study
* Subject is affected by a condition that, in the opinion of the clinical team, may pose additional risks.
Systemic Sclerosis and Jak Inhibitors : Emphasis on Macrophages

The Sclero-JAK project aims to assess the impact of a JAK1/2 inhibitor (ruxolitinib) on activation states of monocytes-derived macrophages (MDM) from systemic sclerosis (SSc) patients

Systemic sclerosis is a fibrotic and inflammatory chronic autoimmune disorder with no disease modifiying drug available to date. JAK inhibitors may represent a relevant therapeutic candidate for this disease;

The primary objective of this study is to characterize the impact of Ruxolitinib (a JAK ½ inhibitor) on the prof-fibrotic properties of MDM from SSc patients in vitro.

The primary outcome will be the concentration of CCL18 evaluate by ELISA in the condition media of MDM from SSc patients pre treated or not in vitro by ruxolitinib.

The secondary objectives :

1. To characterize the impact of ruxolitinib on other pro-inflammatory or pro-fibrotic cytokines
2. To characterize the impact of ruxolitinib on membrane expression of macrophagic polarization markers of MDM from SSc patients
3. To evaluate the impact of ruxolitinib on the phenotype of MDM from healthy donors exposed in vitro to the serum of SSc patients.
4. To determine the variability of the effects of ruxolitinib on MDM of SSc patients depending on key clinical characteristics (diffuse versus limited SSc, patients with or without Interstitial Lung disease ILD)

The secondary outcomes :

1. ELISA of the following cytokine evaluated in the condition media of SSc MDM pre-treated or not with ruxolitinib : PDGFbb, IL-6, CXCL10, CXCL4
2. Membrane expression (flow cytometry) of the following markers expressed by SSc MDM pre-treated or not with ruxoltinib : CD204, CD206, CD163, CD86, CMHII, TLR4.
3. Evaluation of the same cytokines and membrane markers in MDM from HD exposed to serum media of SSc patients.
4. Variation of the effect of ruxolitinib on the primary outcome (CCL18 secreted in the condition media of MDM from SSc patients) in sub groups depending on the following characteristics :

   * Auto antibodies (anticentromere, antitopoisomerase, anti RNA polymerase III or none)
   * modified Rodnan skin score
   * Digital ulcers (current or past)
   * Pulmonary involvement (Interstitial Lung disease on CT scan)
   * Heart involvement (Pulmonary arterial hypertension on echocardiography)

Eligibility Criteria:
Inclusion Criteria:

* patients with systemic sclerosis according to the ACR/EULAR 2013 classification criteria for systemic sclerosis or Patients with systemic lupus according to the ACR2019 classification criteria for systemic lupus
* with informed consent for participation to the study

Exclusion Criteria:

* patients unable to consent
* patients with anemia inferior to 7g/dL
Telephone Support Program for Lung Cancer Patients and Their Family Caregivers

The goal of this project is to examine the physical and psychological health benefits of a novel, telephone-delivered symptom management intervention for advanced lung cancer patients and their family caregivers.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of lung cancer
* Must be able to speak and read English

Exclusion Criteria:

* No working phone service
* Does not have a family caregiver
Sequence Towards Remission in Depression

In this study the investigators use clinical, biological and imaging markers to develop predictive markers for remission from depression. The investigators compare individuals who have received placebo to individuals who have received 10 mg of escitalopram for one week. In this double-blind, randomized study the investigators a) compare the groups to observe the short-term effects of escitalopram and b) study the predictive value of these observations with respect to remission. Measures include, but are not restricted to, limbic emotional reactivity as assessed by fMRI, emotional processing, emotional memory, autobiographical memory.


Eligibility Criteria:
Inclusion Criteria:

* Major depressive disorder with current major depressive episode according to a SCID-I/P interview
* Montgomery-Åsberg depression rating score 15-30
* Age 18-60

Exclusion Criteria:

* Borderline, schizoid or schizotypal personality, bipolar or any psychotic disorder
* Primary diagnosis is anxiety disorder: 300.00, .01, .02, .21, .22, .29, .23, .3, 309.81, 308.3, 293.89
* Significant current suicidal ideation, or history of a suicide attempt
* Lifetime substance dependence; Last-year substance abuse; Last month over 24/16 standard doses of alcohol/week; Lifetime use of illicit substances \> x5; Any illicit substance use in last month
* Depressive disorder due to medical condition or chemical substance
* Antidepressant medication use in last 4 months
* Severe, unstable somatic illness
* Use of antipsychotics, mood stabilizers, systemic corticosteroids, β-blockers or daytime benzodiazepines (a small dose of ≤10mg zolpidem once daily is permissible)
Neurofeedback for Internet Gaming Addiction

The primary aim of this study is to evaluate the therapeutic potential of real-time functional magnetic resonance imaging (MRI) neurofeedback in alleviating internet gaming disorder (IGD) symptoms by training individuals with such symptoms to down-regulate the activity in their reward-processing-related midbrain regions.


Eligibility Criteria:
Inclusion Criteria:

* Meet at least five of the Diagnostic and Statistical Manual of Mental Disorders fifth edition (DSM-5) criteria for IGD and score 38 or above on the Internet Addiction Test (IAT)
* First language is Chinese (Mandarin)
* Right-handed
* Have played the mobile game "King of Glory" for more than 3 years
* Ability to give informed consent
* Normal or corrected-to-normal vision

Exclusion Criteria:

* Any primary diagnosis of a current psychological or neurological disorder
* Any history of psychological or neurological disorder
* Any MRI contraindication
* Currently on a psychotropic medication
* Any history of substance dependence
* Any history of brain injury or surgery
Efficacy, Safety of T2769 in Dry Eye Disease

Efficacy of T2769 in Dry Eye Desease

Multicenter and open study

Eligibility Criteria:
Inclusion Criteria:

* Signed and dated informed consent
* Male or female aged from ≥ 18 years old
* Known Dry Eye Syndrome requiring artificial tears within the last 3 months prior to study screening

Exclusion Criteria:

* Best far corrected visual acuity ≤ 2/10
* Severe blepharitis Severe dry eye
Post-authorisation Safety Study (PASS) of Influenza Vaccine in United Kingdom (UK)

The purpose of this study is to conduct a pilot study to explore the potential use of routinely collected data in General Practitioner (GP) practices to conduct enhanced safety surveillance of seasonal influenza vaccines in the UK, as recommended in the EMA interim guidance on enhanced safety surveillance for seasonal influenza vaccines in the EU.

Data routinely collected as part of clinical consultations in primary care will be extracted from nine General Practitioner (GP) practices in order to estimate medically attended Adverse Events of Interest (AEIs), for people who have received an influenza vaccine. This study will also actively follow patients who were exposed to seasonal influenza vaccination for 7 days in three of the nine GP practices using a customised card-based adverse drug reaction reporting system, in order to determine whether a more active approach to surveillance can capture higher rates of AEIs.

Eligibility Criteria:
Inclusion Criteria:

* All individuals (aged 6 months and above) who will receive seasonal influenza vaccination in the 9 GP practices between 1 September 2015 and 30 November 2015.
* Pregnant women are also included in this study.

Exclusion Criteria:

• Only registered patients who have explicitly opted out of data sharing will be excluded from the analysis.
Postprandial Hemodynamics

To study the postprandial alterations in hemodynamics and blood pressure in relation to gastric emptying rate, postprandial blood glucose, plasma concentrations of insulin, satiety in healthy subjects.

Ingestion of a meal increase blood flow to the gastrointestinal organs and affects the heart rate, blood pressure, and cardiac output. It is not known through wich mechanisms the heart function changes affects after a meal.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects

Exclusion Criteria:

* history of gastrointestinal disease, abdominal surgery or diabetes mellitus
Pethidine Versus Nitrous Oxide for Pain Relief During Labor

Systematic opioids and inhaled nitrous oxide (N2O ) are common methods for pain relief during labor. The aim of the current study is to evaluate the efficacy of systemic pethidine compared to N2O given for pain relieve in term, multiparous women in labor.

Pain relief during labor and delivery is an essential part of good obstetrical care. Labor pain and its relief have implications on the course of labor, maternal and fetal outcomes and the satisfaction with childbirth overall. Many women would like to have a choice in pain relief during labor but also would like to avoid invasive methods of pain management in labor (as epidural). Both, inhaled analgesia and parenteral opioids are common pharmacological interventions aim to relieve the pain of labor.Nitrous oxide in a 50/50 mix with oxygen is the most common concentration used for labor pain management. It is self-administered via facemask, intermittently, and has rapid onset and offset effect. Main side effects, including nausea, vomiting, dizziness and drowsiness. Pethidine is one of the most frequently used opiate agonists. It can be given intravenous or intramuscularly. Its analgesic effect starts within 10-20 minutes and lasts 2-4 hours. Reported maternal side effects include nausea, vomiting and dysphoria. Pethidine may lead to changes in fetal heart rate tracing during labor, respiratory depression, impaired sucking reflex and restlessness.

Given the fact that these two routine interventions are given in different ways and have different side effects profile, the investigators aim in this randomized controlled trial to compare the analgesic effect of these two methods and their maternal and perinatal secondary effects in multiparous laboring women.

Eligibility Criteria:
Inclusion Criteria:

1. Multiparity (para 2 or more).
2. Term pregnancy: 37-42 weeks of gestation.
3. Singleton pregnancy.
4. Vertex presentation.
5. In labor: at least 2 contraction in ten minutes and cervical dilatation of 2 centimeters or more.

Exclusion Criteria:

1. Women who desire epidural as a first line analgesia during labor.
2. Women receiving pethidine during the last 24 hours (prior to entering labor room).
3. Contra-indication for vaginal delivery.
4. Contra-indication or allergic reaction to either pethidine or nitrous oxide.
5. History of drug abuse.
6. Previous cesarean delivery.
Comparison of Weight Management Programs Delivered in Large Versus Small Groups

The purpose of this study is to compare the 6- and 12-month weight changes associated with lifestyle interventions delivered in a large group or small groups of participants. It is hypothesized that participants receiving treatment in a small group will have greater weight loss than those assigned to a larger group.


Eligibility Criteria:
Inclusion Criteria:

* at least 21 years-old
* body mass index (BMI) between 30-45

Exclusion Criteria:

* have lost \>4.5 kg in past six months
* have medical condition(s) likely to affect ability to participate in physical activity
* planning to relocate from the area in next 12 months
* unable or unwilling to attend weekly group sessions
* unwilling to accept random assignment
Characterization of the Patient Population With Galactosialidosis

The late infantile form of galactosialidosis is potentially amenable to treatment by gene transfer with an adeno-associated viral vector encoding Protective Protein Cathepsin A (PPCA) or by infusion of purified protein. The published literature contains limited descriptions of the disease nor is it known how many patients with the disorder are potentially available for protocol enrollment. This preliminary study is designed to define the demographics and clinical characteristics of the patient population with galactosialidosis. Individuals for whom DNA diagnosis has been performed at St. Jude Children's Research Hospital (SJCRH) will be contacted telephonically to learn their current status. In addition, a letter requesting information regarding patients with galactosialidosis will be sent to all pediatric geneticists throughout the United States. Selected physicians with expertise in lysosomal storage diseases throughout the world will also be contacted. Foundations and Associations for the lysosomal storage disorders will also be contacted in an effort to identify additional potential patients with galactosialidosis. The information to be collected in this preliminary study will facilitate development of specific eligibility criteria for future therapeutic studies.

Individual patient/families will be interviewed by telephone to learn basic demographic information and disease status. Medical records will be requested from primary care providers to provide further information regarding their disorder. Individual patients identified through our survey of pediatric geneticists or via the disease foundations or associations will be sent a letter describing our purpose and which includes a consent form for a subsequent telephonic interview. Their medical records will also be requested.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with suspected or confirmed molecular diagnosis of galactosialidosis who are ≥ 6 months of age.

Exclusion Criteria:

* Individuals with a lysosomal storage disorder who have been shown to have a mutation in a gene other than that encoding PPCA.
Effect of Dry Cupping and Ischemic Compression on the Trigger Point on the Upper Trapezius Muscle

Ischemic compression is considered the fastest and most common method for providing relief in trigger point therapy, whereas cupping therapy is not a method often used for this purpose. The muscle that has a great impact on tension-type headaches and neck pain is the trapezius, whose upper fibres are where the most common trigger point in the back is located.

The aim of this study was to evaluate and compare the effectiveness of single ischemic compression and single dry cupping therapy on the most common trigger point, on the descending part of the trapezius muscle.


Eligibility Criteria:
Inclusion Criteria:

* age 18-30
* student of The Józef Piłsudski University of Physical Education in Warsaw
* written consent to participate in the study

Exclusion Criteria:

* past or current injury to the trapezius.
* past or current injury of the cervical spine limiting mobility of this segment.
* broken skin at the examination site.
* cardiological disease and use of blood pressure medication, histamine medication and analgesics
* elevated body temperature, illness symptoms and a period of convalescence.
* a missed anti-Covid procedure before each examination.
* inability to find trigger points.
Anti-Snoring Appliances and Airway Manipulation in Patients Undergoing Anesthetic Sedation

Would patients using an anti-snoring appliance intraoperatively require less airway manipulation, interventions, and rescue maneuvers during anesthetic sedation cases compared to those who do not? The investigators will use anti-snoring appliance devices (specifically the FDA approved Zyppah) to attempt to relieve tissue obstructions that cause snoring during sleep. The application of the devices to the body is less invasive than other common intraoperative rescue airway devices (e.g. nasal trumpets and oral airways) which are not designed to be patient specific.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (age 18-89 years old)
* Undergoing procedures below the umbilicus requiring anesthetic sedation without an invasive airway
* a STOP-BANG (survey) score of 2 or greater.

Exclusion Criteria:

* Patients who are unable to consent
* Non-English speaking
* Those requiring general anesthesia.
Evaluation of CG-100 Intraluminal Bypass Device

Evaluation of CG-100 Intraluminal Bypass device


Eligibility Criteria:
Inclusion Criteria (pre-operative):

1. Willing to comply with protocol-specified follow-up evaluations
2. 22-75 (inclusive) years of age at screening
3. Diagnosed with colorectal cancer
4. Has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent