cyrilzakka/clinical-trials huggingface dataset:
Aging, Geriatric Syndromes and Clonal Hematopoiesis

In this study the investigators will incorporate a wide range of clinical variables associated with aging and cardiovascular disease to determine whether they are associated with mutation status independent of chronologic age. Clinically, aging can be operationalized using geriatric assessment, which entails a comprehensive multi-dimensional assessment of the health of an older adult, including measures of comorbidity, polypharmacy, functional status, cognition, depression, falls, social activities and social support. Given that aging is heterogeneous, geriatric assessment allows greater specificity for aging than chronological age alone.


Eligibility Criteria:
Inclusion Criteria:

* At least 50 years of age.
* Able to understand written and spoken English.
* Able to understand and willing to sign an IRB-approved written informed consent document (or that of a legally authorized representative, if applicable for the trauma cohort)

Exclusion Criteria:

* Inability or unwillingness to complete health questionnaire.
* History of a recent (\<30 days) acute viral illness.
* Current cancer diagnosis and currently receiving chemotherapy or undergoing radiation therapy. A prior history of cancer is allowed if the participant completed therapy \> 1 year prior to enrollment; participants with a prior diagnosis of cancer will be asked to sign a release of information for the research team to obtain records regarding their prior cancer treatment.
* Current use of drugs that cause DNA damage (e.g. Cytoxan, azathioprine, etc.) for the treatment of a non-malignant disease.
* Vulnerable populations (e.g. prisoners).
* Known infection with Hepatitis B or C, HTLV, or HIV.
* Additional exclusion for optional bone marrow aspirate/biopsy substudy:

  * Use of medications for anticoagulation or "blood thinning" including warfarin, low molecular weight heparins (enoxaparin, daltaparin) or direct-acting oral anticoagulants (dabigatran, rivaroxaban, apixaban, edoxaban or betrixaban)
  * allergy to lidocaine or other local anesthetics.
JAB-3068 Activity in Adult Patients With Advanced Solid Tumors

To evaluate the safety and tolerability of JAB-3068 administered in investigational regimens in adult participants with advanced solid tumors.

To assess the safety and tolerability and determine the recommended phase 2 dose (RP2D) of JAB-3068 in combination with PD1 inhibitor in patients with advanced solid tumors.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent, according to local guidelines, signed and dated by the participant prior to the performance of any study-specific procedures, sampling, or analyses.
* Participant must be ≥18 years of age at the time of signature of the informed consent form (ICF).
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.

Exclusion Criteria:

* History (≤3 years) of cancer that is histologically distinct from the cancers under study, except for cervical carcinoma in situ, superficial non-invasive bladder tumors, or curatively treated Stage I non-melanoma skin cancer
* Known serious allergy to experimental drugs
* Brain or spinal metastases, except if treated by surgery, surgery plus radiotherapy or radiotherapy alone, with no evidence of progression or hemorrhage for ≤21 days before the start of treatment with the study drugs, and has not received any systemic corticosteroids for ≥21 days before the start of treatment with the study drugs
Optimal Number of Hyperbaric Oxygen Treatments for Carbon Monoxide Poisoning

The optimal treatment strategy with hyperbaric oxygen therapy has been the subject of some debate over the past 3 decades. Initial landmark studies showed a decrease in the incidence of DNS with a single treatment and also with three treatments over the course of 24 hours. These two strategies have continued to be used widely without further evidence comparing them in a direct fashion. Retrospective publications in the years since have been largely conflicting about the benefit of additional hyperbaric treatments. The investigators would seek to randomize patients with carbon monoxide poisoning to receive with 1 or 3 treatments with hyperbaric oxygen and measure their neurologic outcomes.

HBO is a niche treatment modality, especially in Canada. There are few sites which offer this care, and as such, treatment often carries significant logistical challenges. Since 2021, the HBO unit at the Misericordia hospital has averaged 49 patients per year being treated for CO poisoning. This HBO unit provides coverage to patients within Alberta, Saskatchewan, Manitoba, Yukon, and Northwest Territories. Due to the significant barriers to treatment, including the high cost to the public system, it is important to clearly understand how to best treat these patients.

Purpose:

The aim of this study is to assess whether a single treatment session of hyperbaric oxygen is non-inferior to three treatments for patients with acute carbon monoxide poisoning.

Eligibility Criteria:
Inclusion Criteria:

* All adult (over 17 years old) patients referred to a Hyperbaric Unit for acute carbon monoxide poisoning.

Exclusion Criteria:

* Obtunded
* Mechanically ventilated
* Pregnant
* Incarcerated
* Cognitively impaired (acutely or chronically)
Performance Evaluation of Malaria Plus Rapid Diagnostic Tests (RDTs) for the Detection of Plasmodium Infections in Patients With Symptoms Suggestive of Malaria

This trial is part of a portfolio of studies designed to assess the clinical and operational performance of Abbott's NxTekTM Malaria Pf Plus and NxTekTM Malaria Pf/Pv Plus Rapid Test Devices.

A prospective cross-sectional multi-center diagnostic accuracy trial in intended-use settings of the:

1. NxTekTM Malaria Pf/Pv Plus Rapid Test Device for the qualitative detection histidine-rich protein II (HRP-II antigens) and pLDH of Plasmodium falciparum (P.f) and Plasmodium vivax (P.v) malaria in human whole blood.
2. NxTekTM Malaria Pf PlusRapid Test Device for the qualitative detection of histidine-rich protein II (HRP-II antigens) and pLDH of Plasmodium falciparum (P.f) malaria in human whole blood.

Eligibility Criteria:
Inclusion Criteria:

* Aged 5years old or older
* Presenting at the trial site with fever or a history of fever (axillary temp ≥ 37.5C) during the preceding 48hours
* Freely agreeing to participate by providing informed consent (and assent, if applicable)

Exclusion Criteria:

* Presence of symptoms and signs of severe illness and/or central nervous system infections as defined by WHO guidelines.
The Effect of Puppet Show on Pain and Fear During Subcutaneous Injection in Children With Leukemia

This study aim to evaluate the effect of puppet show applied during subcutaneous injection to children aged 3-7 years with leukemia on the level of pain and fear experienced by children due to the intervention.

Before and during subcutaneous injection administration to the children in the study group There will be a puppet show. No distraction method will be applied to the children in the control group and the clinical A subcutaneous injection will be administered in accordance with the routine. Pain and fear assessment of children in both groups will be evaluated by the clinical nurse during the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Child \<3 and \>7 years old
* Medically unstable (dehydration, septic shock, sedation)
* Children who are being treated for leukemia in the Pediatric Hematology Service will be included in the study.

Exclusion Criteria:

* Not exposed to any other interventional procedure before (same day) subcutaneous intervention
* Not expressing any pain before subcutaneous intervention
* Heart rate to be within age-appropriate limits
* Wong-Baker Pain Rating Scale score of 0 in the evaluation performed before the subcutaneous intervention (5 minutes ago)
* Having a disability that cannot perceive the attempt and communicate (down syndrome, speech disorder, visual impairment)
* The child and family do not know Turkish
A Study on the Effect of Food on the Pharmacokinetics of RO5428029 in Healthy Volunteers

This open label, two period, crossover study will evaluate the safety and the effect of food on the pharmacokinetics of RO5428029 in healthy volunteers. In a crossover design, healthy subjects will be randomized to receive a single oral dose of RO5428029 with or without food, with a washout period of at least 7 days between dosing and a follow-up of 7 to 10 days after last dose. Anticipated time on study will be up to 21 days.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers, 18 to 60 years of age inclusive
* Body mass index (BMI) between 18 and 29.9 kg/m2, inclusive, and a minimum weight of 45 kg
* Female subjects must be surgically sterile or post-menopausal
* Male subjects and their partners of child-bearing potential must use 2 methods of contraception (one of which a barrier method) for the duration of the study and for at least 70 days after the last dose

Exclusion Criteria:

* Pregnant or lactating women, and male partners of women who are pregnant or lactating
* Women with reproductive potential
* History (within 3 months of screening) of alcohol consumption exceeding 2 standard units per day on average; alcohol consumption will be prohibited at least 48 hours before screening
* Positive test for drugs of abuse
* History or symptoms of any significant disease
* Positive for HIV, hepatitis B or hepatitis C infection
* Participation in an investigational drug or device study within 3 months prior to screening
Response Inhibition Training for Children With Williams Syndrome

The investigators will conduct a pilot study investigating the effectiveness of a computerized response inhibition training program at reducing the response inhibition difficulties often seen in children with Williams syndrome ages 10-17. The investigators hypothesize that after completing the training program, children with Williams syndrome will show improvement on computerized measures of response inhibition and on parent measures of impulsivity.

Behavioral characteristics of individuals with Williams syndrome include eagerness to approach and interact with others (including strangers), repeated questions especially about upcoming events, and difficulties with attention, impulsivity, and inhibition. There is very little systematic research about the kinds of interventions that are most useful for children with Williams syndrome to support optimal psychosocial functioning, and of the effectiveness of such interventions. We will conduct a pilot study of a potential intervention to address the response inhibition difficulties associated with Williams syndrome. The investigators will examine the utility of an online, web-based computerized cognitive retraining program aimed at addressing impulsivity and inhibition difficulties in 20 children, ages 10-17, with WS. The engaging training program has shown some utility in other populations, including children with tic disorders and trichotillomania. The investigators will examine the acceptability and feasibility of the treatment approach, as well as its impact on performance on experimental measures of impulsivity and on everyday psychosocial functioning as rated by parents; this study will consist of a small-scale pilot Randomized Clinical Trial with wait list. Through this novel work, we hope to develop and tune this approach for optimal outcomes and to demonstrate the promise of this intervention to address common challenges of people with Williams syndrome in the area of inhibition.

Eligibility Criteria:
Inclusion Criteria:

* Williams syndrome (diagnosed with genetic testing)
* Ages 10-17
* First language and main language spoken in the home is English
* Possess computer in the home that has internet access, and a second electronic device with access to Skype (e.g., smartphone, ipad, additional computer, ipod touch)

Exclusion Criteria:

* First language and main language spoken in the home is NOT English (because study measures and instructions are all in English)
* No computer in the home with internet access (because the study is being conducted via the internet)
* Comorbid severe illnesses or major surgery within the past 6 months
* Four or more previous sessions of inhibition training
Ergometrine Versus Oxytocin in the Management of Atonic Post-partum Haemorrhage (PPH) in Women Delivered Vaginally

200 women with PPH will be randomly divided into 2 equal groups using computer generated random numbers. Group 1 will receive Ergometrine 400µgm (Methergin® Novartis, Switzerland) and group 2 will receive oxytocin 10 IU (Syntocinon®, Novartis, Switzerland). The investigators will not include a control group for ethical reasons.

Obstetric haemorrhage remains one of the major causes of maternal death in both developed and developing countries. Postpartum haemorrhage (PPH) is defined as a blood loss \>500 ml more of blood from the genital tract within 24 hours of the birth of a baby. PPH can be minor (500-1000 ml) or major (more than 1000 ml). The most frequent cause of PPH is uterine atony, contributing up to 80 % of the PPH cases.

Risk factors of atonic PPH include multiple pregnancy, placenta previa, previous PPH, body mass index (BMI) \>30, prolonged labour, fetal macrosomia\>4kg and primipara\> 40 years.

Oxytocin is currently the uterotonic of first choice. It has proven to decrease the incidence of PPH by 40 % and has a rapid onset of action and a good safety profile. A disadvantage of oxytocin is its short half-life of 4-10 min, regularly requiring a continuous intravenous infusion or repeated intramuscular injections. Despite decades of empirical use in clinical practice, there are no trials comparing ergometrine and oxytocin as first-line agents for the treatment (rather than prevention) of PPH.

The study will be conducted in Cairo university hospitals and BeniSuef university hospitals. All patients attending the labour ward will be invited to participate in the study, the invitation will include a clear full explanation of the study. Only patients signing informed written consents will participate in the study.

200 women with PPH will be randomly divided into 2 equal groups using computer generated random numbers. Group 1 will receive Ergometrine 400µgm (Methergin® Novartis, Switzerland) and group 2 will receive oxytocin 10 IU (Syntocinon®, Novartis, Switzerland). The investigators will not include a control group for ethical reasons.

Once atonic PPH is diagnosed, 2 14-gauge cannulas will be inserted and a crystalloid intravenous (iv) infusion will be started. The allocated drug will be diluted in 10ml saline and will be given slowly iv, the fundus will be rubbed, A Foley's catheter will be inserted and a fluid balance chart will be commenced, pulse and blood pressure will be recorded every 15 minutes, venepuncture will be done for cross matching 4 units of blood, full blood count and coagulation screen.

The uterine tone and amount of bleeding will be noted and the need for further uterotonic agents will be determined 2 minutes after giving the drug. Blood loss will be estimated through weighing the swabs and using pictorial charts. Blood haemoglobin will be assessed 24 hours after delivery.

Eligibility Criteria:
Inclusion Criteria:

* Atonic PPH

Exclusion Criteria:

* Gestational age\<37 weeks
* Hypertension, cardiac disease or preeclampsia
Early Pancreatic Stent Placement for Preventing PEP

Our aim is to compare early versus late pancreatic stent placement in preventing PEP among patients with naive papilla. The EVL trial will provide essential answers regarding the optimal timing of prophylactic pancreatic stent placement in PEP prevention.All patients with difficult biliary cannulation undergoing endoscopic retrograde cholangiopancreatography (ERCP) with pancreatic guidewire-assisted technique for biliary access will be told about the opportunity to participate in EVL research. In total, 768 patients will be randomly assigned (1:1) to two arms: (1) early pancreatic stent placement (EPSP) (a pancreatic stent will be placed immediately after endoscopic retrograde cholangiography (ERC) or endoscopic sphincterotomy (EST)) and (2) late pancreatic stent placement (LPSP) (a pancreatic stent will be placed after all completion of therapeutic biliary procedures, e.g. biliary stone removal or drainage).The primary outcome is the rate and severity of PEP. The secondary outcomes are hyperamylasemia, the rate of stenting success, and other ERCP-related adverse events (AEs).

Patients with challenging biliary access using pancreatic guidewire-assisted method will be enrolled in the study. Recruitment will take place among individuals referred to the four participating centers for therapeutic biliary procedures. After obtaining signed consent forms, participants who meet all the inclusion criteria and have no exclusion criteria will be randomly grouped (with a 1:1 ratio) into EPSP and LPSP

Eligibility Criteria:
Inclusion Criteria:

Participants who fulfill all the below criteria will be enrolled: 1. with naive papilla; 2. over 18 years; 3. undergoing ERCP with pancreatic guidewire-assisted technique for biliary access; 4. providing a signed, written informed consent.

Exclusion Criteria:

Participants who meet any of the following criteria will be excluded: 1. unreachable main papillae; 2. surgically altered gastrointestinal anatomy; 3. concurrent acute pancreatitis; 4. biliary cannulation over pancreatic duct stent after precut sphincterotomy or wire-guided method (native early attribute); 5. failed biliary cannulation; 6. severe active cardiopulmonary disease; 7. breastfeeding or pregnancy; 8. ampullary tumour.
Pain Predict Genetics

Pain is the most frequent cause of suffering and disability in society. Despite considerable involvement of genetic factors in pain sensation and sensitivity, the individual genes involved remain largely unidentified.

In this project the investigators will follow patients undergoing elective major surgery for the development of acute and chronic pain. The investigators will search for clinical as well as genetic factors that can predict the development of pain. These can serve as biomarkers to predict acute and chronic pain development and progression in individual patients and help early individual treatment adaptation.

Pain is the most frequent cause of suffering and disability in society. Chronic pain seriously impairs quality of life of millions of people worldwide. 10-50% of surgical patients report chronic pain after surgery; up to 10% report severe pain. Thus, chronic pain is a significant medical and financial burden to society.

Despite considerable involvement of genetic factors in pain sensation and sensitivity, individual genes involved remain largely unidentified. Knowledge of genetic factors, their phenotypic expression in pain processing, and their link to neuronal correlates can improve understanding of pain aetiology and processes involved in pain perception and chronification. Also, they can serve as biomarkers to predict chronic pain development and progression in patients and help early individual treatment adaptation.

In this study the investigators will establish a prospective database and biobank of patients undergoing elective major surgery. Using data from the database and biobank, the investigators will identify genetic factors contributing to development of acute and chronic pain after surgery.

Over a period of 10 years the investigators will prospectively include up to 10,000 patients visiting the hospital for elective major surgery. Data defining participants demographics, medical history and questionnaire data will be collected and stored in dedicated databases. Additional details (surgery and perioperative management, pain processing phenotypes and surgical and pain outcomes) will be stored.

Eligibility Criteria:
Inclusion Criteria:

Patients:

* Ages 18 - 80 years, consenting, planned surgery, able to understand and answer questionnaires.

Exclusion Criteria:

* Non-consent, inability to give consent, unplanned and emergency surgery.
Long Term Safety of Naldemedine

The purpose of this study is to evaluate the long-term safety of naldemedine for the treatment of constipation due to opioid therapy.


Eligibility Criteria:
Inclusion Criteria

1. Subjects aged 18 to 80 years inclusive at the time of informed consent
2. Subjects must have non-malignant chronic pain treated and must have opioid induced constipation (OIC)
3. Subjects must be treated with a stable opioid regimen at a total daily dose on average of ≥ 30 mg equivalents of oral morphine sulfate
4. Subjects may or may not be on a routine laxative regimen at the time of Screening

Exclusion Criteria

1. Evidence of significant structural abnormalities of the gastrointestinal (GI) tract
2. Evidence of active medical diseases affecting bowel transit
3. History of pelvic disorders that may be a cause of constipation
4. Surgery (except for minor procedures) within 60 days of Screening
5. History of chronic constipation prior to starting analgesic medication or any potential non-opioid cause of bowel dysfunction that may be a major contributor to the constipation (e.g. mechanical GI obstruction)
6. Subjects who have never taken laxatives for the treatment of OIC
7. Current use of any prohibited medication including opioid antagonists, partial or mixed agonists/antagonists
Active Ingredients & Efficacy of Aquatic Therapy for Autistic Children

Accidental drowning is the number one cause of death in children with autism spectrum disorders (ASD) and highlights the critical need for swim lessons and water safety training for this population. Our team has developed and tested an innovative, occupational therapy (OT) based aquatic program - AquOTic - that provides preliminary support for the use of an individualized swim skills training intervention in children with ASD. The AquOTic program uses a combination of sensory, motor learning, and behavioral approaches to improve water safety and swim skills. In this study, we will use a randomized control trial design to identify the efficacy of the AquOTic intervention to improve swim performance in children with ASD.

Once enrolled, children will be randomized to one of three groups. Group A will receive the intervention right away. Group B will use a waitlist control for 10 weeks, then will receive the intervention. Group C will be a control group, and will be offered the intervention at the end of the control period. Each group will have 12 participants.

AquOTic a group based aquatic occupational therapy intervention that uses evidence-based therapeutic teaching techniques including therapeutic relationship, grading of activities, shaping, positive reinforcement and individualized goals to direct the intervention.

We will also develop a fidelity measure to operationalize the therapeutic strategies and quantify the active ingredients of the AquOTic program. Our long-term goal is to create evidence for an OT-based swim intervention for children with ASD that has the potential to decrease the drowning risk in this population.

Eligibility Criteria:
Inclusion Criteria:

* pre-existing diagnosis of autism \& interest in learning to swim

Exclusion Criteria:

* able to float or move through the water for 5-10 feet without assistance.
* presence of compromised airway such as trachea or ventilation system
* other contraindication to submersion in water.