cyrilzakka/clinical-trials huggingface dataset:
Awareness, Care, and Treatment In Obesity Management of Patients With Hemophilia (ACTION) to Inform Hemophilia Obesity Patient Empowerment (HOPE)

An online web-based cross-sectional survey in which participants will complete a distinct questionnaire for patients with hemophilia and obesity (PwHO) and/or their carers/spouses/partners, or a distinct questionnaire for healthcare professionals. Each questionnaire consists of more than 100 items including pre-coded (multiple choice) closed-ended questions, yes/no questions and rating scales. It is estimated that this one-off survey will take approximately 45-60 minutes to complete.

As a cross-sectional study, there will be no treatment of patients.


Eligibility Criteria:
Inclusion Criteria:

* Meeting one of the following criteria: a) Adults (any gender) aged equal to or more than 18 years with hemophilia (any severity, with or without inhibitors) self-identified with obesity or overweight, - OR - Caregivers of children (any gender) currently aged less than18 years with hemophilia (any severity, with or without inhibitors) caregiver-identified with obesity or overweight, - OR - Spouses or partners of adults (any gender) aged equal to or more than 18 years with hemophilia (any severity, with or without inhibitors) self-identified with obesity or overweight - OR - Healthcare professional (pediatric or adult hematologist, nurse, nurse practitioner, physician assistant, physical therapist, social worker) actively working in a federally designated hemophilia-treatment center for at least 3 years and with experience managing patients with hemophilia and obesity or overweight.
* Participants must have access to the internet, either at home or at a location convenient to them
* Provision of informed consent before the start of any survey-related activities.

Exclusion Criteria:

* Inability to understand and comply with written instructions in English
* Previous completion of this study with receipt of compensation
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
Oral Aromatase Inhibitors Modify the Gut Microbiome

The purpose of this research is to study the bacteria in participants' gut before receiving a medicine called an aromatase inhibitor for breast cancer and after participants receive medicine for breast cancer.

Primary Objective: To describe the microbiome shift of gut microbiome from baseline after 4-weeks and 12-weeks of oral aromatase inhibitor treatment.

Secondary Objective

* To correlate gut microbiome populations with circulating sex hormone metabolite concentrations at baseline and 12 weeks.
* To describe the correlation of change in the microbiome populations with change in circulating sex hormone metabolite concentrations from baseline to 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Pathologic diagnosis in situ or invasive breast cancer for which initiating aromatase inhibitors therapy is recommended or initiating aromatase inhibitors for risk reduction.
* ECOG performance status 0,1, 2, 3.
* Age ≥ 18 years
* HER2+ breast cancer is allowed if patients are on a monoclonal antibody therapy for which a change is not anticipated while on study (12 weeks) and they have been on the monoclonal antibody therapy for at least 4 weeks.
* Ability to read, understand and evaluate study materials and willingness to sign a written informed consent document.

Exclusion Criteria:

* Have been on antibiotics within 4 weeks of enrollment.
* Administered chemotherapy less than 4 weeks prior to enrollment.
* Hormone replacement (defined as only estrogen and/or progesterone replacement) or anti-estrogen therapy within 4 weeks of starting aromatase inhibitors
* Use of antibody drug conjugate (HER2+ breast cancer)
* Male breast cancer
* Any serious and/or unstable pre-existing medical, psychiatric, or other existing condition that would prevent compliance with the trial or consent process
Clinical Study of KW-2246 in Patients With Cancer Pain

This study is a Phase II open-label study to investigate the recommended conversion ratio (oral morphine dose to KW-2246) when switching oral morphine or oxycodone to KW-2246 in cancer patients.

This study is a Phase II open-label study to investigate, using the continual reassessment method procedure by pain intensity and safety as indicators, the recommended conversion ratio (oral morphine dose to KW-2246) when switching oral morphine or oxycodone to KW-2246 in cancer patients who have been maintained on oral morphine or oral oxycodone for pain and to evaluate the safety and efficacy of KW-2246.

Eligibility Criteria:
Inclusion Criteria:

1. Provide written informed consent to participate in the study.
2. Be able to be hospitalized.
3. Between the ages of 20 and 80 years (inclusive) at the time of giving written informed consent.
4. Have regularly received oral morphine or oral oxycodone at an oral morphine equivalent dose of 20 to 120 mg/day for at least 2 days before study entry, AND not have required any rescue dose between regular doses.
5. Not have experienced intolerable toxicity for 2 days before study entry.
6. Have cancer that is in stable condition at study entry and expected to remain stable during the KW-2246 treatment period.
7. Have a life expectancy of at least 1 month after the start of KW-2246 administration.
8. Considered to be able to keep the patient diary.

Exclusion Criteria:

1. Serious respiratory dysfunction.
2. Asthma.
3. Serious bradyarrhythmia.
4. Serious hepatic or renal dysfunction.
5. Susceptibility to respiratory depression due to such conditions as increased intracranial pressure, head injury and brain tumor.
6. History of convulsive seizures (except a single episode of infantile febrile convulsions).
7. Current or past history of drug dependence or narcotic abuse.
8. Dry mouth that affects oral intake.
9. Use of opioid analgesics other than oral morphine or oxycodone within 7 days prior to study entry.
10. Use of narcotic antagonists within 7 days prior to study entry.
11. Interventions that may affect pain evaluation, such as surgery, radiation to the pain site (including those sites that influence pain) and nerve block, within 7 days prior to study entry or scheduled to be given during the study.
12. Patients with a history of serious adverse reactions to the combination of opioid analgesics and other drugs/substances who are currently receiving or expected to receive those drugs/substances combined to opioid analgesics.
13. History of hypersensitivity to fentanyl.
14. Pregnant or lactating women, possibly pregnant women or women who are planning to become pregnant.
15. Participation in any other clinical trial within 28 days prior to the start of KW-2246 treatment.
16. Prior exposure to KW-2246.
17. Patients whom an investigator judge unsuitable for enrollment.
Predictors of the Quality of Surgical Reduction and Long-term Outcome

Acetabulum fractures are complex, relatively rare lesions linked to a more or less good functional prognosis and therefore represent a real surgical challenge.

In the literature, it is accepted that surgical delay, among other things, negatively impacts the quality of surgical reduction. However, this reduction must be a major priority since it is one of the factors conditioning the functional result.

In our study, we wish to analyze a particular type of fracture, less studied, or with small series, that are the transverse fractures (+/- posterior wall), known for their difficulty of reduction. The reduction is even greater as the fracture line often passes through the acetabular bearing zone, compromising the functional prognosis.

The choice of surgical approach for this type of fracture is controversial. More and more, a single approach, usually posterior, without compulsory fixation of the anterior component of the transverse fracture is preferred over the traditional double approach anterior and posterior, and this in particular to reduce the morbidity of this surgery.

But this one-size-fits-all approach does not always achieve a good reduction and it is believed that the time to surgery may play a role.

If it is accepted that the surgical delay before reduction in osteosynthesis of an acetabular fracture is involved in the quality of the reduction and therefore the functional result in these patients, the question asked is whether this delay should condition the choice of a double approach, anterior and posterior, for this type of fracture (transverse +/- posterior wall).

Indeed, with increasing surgical time, the risk of scar tissue formation and early callus increases, making bone fragments less mobile, reduction more difficult and indirect reduction techniques (which are used when single approach is chosen) less efficient.

In addition, most of the studies evaluating the quality of reduction of acetabular fractures use a radiographic score, that of Matta.

However, it has been shown that the CT scan was more efficient than the x-rays in detecting a residual displacement of the fracture. Also, in this study, we want to analyze the quality of reduction thanks to the scanner, which is rarely done in the literature.

This work aims to determine the predictive factors of the quality of reduction of transverse fractures +/- posterior wall of the acetabulum, evaluated on the postoperative CT scan.


Eligibility Criteria:
Inclusion Criteria:

* Patient whose age is ≥ 18 years
* Patient with transverse fractures +/- posterior wall of the acetabulum
* Patient cared for at Paris Saint-Joseph Hospital, between 2006 and 2020
* French-speaking patient

Exclusion Criteria:

* Patient under guardianship or curatorship
* Patient under legal protection
* Patient deprived of liberty
* Patient not operated
* Patient with an undisplaced fracture
* Patient who did not have a post-operative control scan
* Patient objecting to the use of their data for this research
Efficacy and Tolerability of ABB I5 Prebiotic and ABB C22 Postbiotics for the Management of Constipation and Gastrointestinal Well-being: a Pilot Trial

In this study, we aim at assessing the benefits of dietary supplementation with ABB i5 and ABB C24, a combination of the the prebiotic ABB i5 and the postbiotic ABB C22, on the gut microbiota of people with constipation and on their gastrointestinal well-being.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who require hospitalization
* Constipation defined as the Rome IV criteria for constipation
* Patients with the ability to take the study product orally

Exclusion Criteria:

* History of allergy, idiosyncrasy, hypersensitivity or adverse reactions to the active principle or to any of the excipients.
* History or evidence of any medical conditions or medication used that, in the opinion of the principal investigator, could affect the safety of the subjects or interfere with the study evaluations
* Patients last palliative care en stage of "end of life" or "terminal"
* Amytriptilin (anti-depressive) and masalazine (anti-inflammatory) treatment
* Laxatives
* Antibiotic treatment in the previous 2 weeks
* Patients with IBS or any other gastrointestinal conditions that maybe the cause of the constipation
Ondansetron Prior Spinal Anaesthesia

Since Ondansetron is commonly used during cesarean deliveries to treat nausea and vomiting, this study will observe the correlation between ondansetron administration and effect on hemodynamics in order to confirm that the use of Ondansetron can reduce incidence of hypotension and bradycardia associated with spinal in cesarean section, and to identify the optimal timing and dose for administration.

Hypothesis:

Administration of ondansetron prior to spinal anesthesia can attenuate hypotension and bradycardia.

Aim:

Since Ondansetron is commonly used during cesarean deliveries to treat nausea and vomiting, this study will observe the correlation between ondansetron administration and effect on hemodynamics in order to confirm that the use of Ondansetron can reduce incidence of hypotension and bradycardia associated with spinal in cesarean section, and to identify the optimal timing and dose for administration.

Objectives:

* Primary outcome: incidence of hypotension after spinal anaesthesia in the patients who received Ondansetron and those who did not
* Secondary outcome : use of vasopressors , bradycardia , timing of administration of Ondansetron wether it is more or less than five minutes prior to the administration of anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant patients undergoing elective caesarean section

Exclusion Criteria:

* Preeclampsia
* Eclampsia
* Hypertension
* Diabetes
AI Activity Study in Patients With Elevated Blood Pressure

In this pilot RCT, a total of 40 adults with hypertension will be randomized to either an artificial intelligence (AI) physical activity intervention group or an active control group with a 1 to 1 ratio after completing a 2-week run-in period and 4-week training. The AI intervention group will receive an automated and personalized daily step goal intervention involving a sophisticated activity analytics algorithm using advanced statistics and machine learning, while the active control group will receive a standardized and fixed 10,000 daily steps goal. Both groups will receive an identical smartphone app (app content differs between the two groups) and ActiGraph GT9X Link to assess objectively measured physical activity (primary outcome) during the study period.


Eligibility Criteria:
Inclusion Criteria:

* age ≥18 years
* systolic blood pressure between 130 mmHg to 180 mmHg or/and diastolic blood \*pressure between 80 to 100 mmHg in a research office
* speaking and reading English
* being physically inactive at work or during leisure time and willing to be physically active
* having an iPhone 8 or newer or an Android Lollipop or newer

Exclusion Criteria:

* self-reported diagnosis of coronary heart disease, medical condition or other physical problem necessitating special attention in an exercise program (e.g., cancer, eating disorder, uncontrolled diabetes)
* current participation in a lifestyle modification program or research study
* self-report of being currently pregnant.
Impact of COVID-19 Pandemic on Hepatopancreatobiliary Surgical Services in Singapore

This paper is intended to report our observational study in evaluating the impact of the COVID-19 pandemic on Tan Tock Seng Hospital hepatopancreatobiliary unit's surgical workload from January to June across 2019 to 2022, corresponding to the pre-pandemic baseline to its peak and the gradual normalization of hospital services as Singapore entered the transition phase to COVID-19 resilience.

This paper is intended to report our observational study in evaluating the impact of the COVID-19 pandemic on Tan Tock Seng Hospital hepatopancreatobiliary unit's surgical workload from January to June across 2019 to 2022, corresponding to the pre-pandemic baseline to its peak and the gradual normalization of hospital services as Singapore entered the transition phase to COVID-19 resilience.

A comparative audit of the unit's surgical workload for the months of January-June across 2019 to 2022, which corresponded to pre-COVID-19, the height of the pandemic, and a gradual normalization of surgical services. Operations performed by the unit were collected from the surgeons' electronic case logs. These operations were sorted based on the Singapore Ministry of Health's table of surgical procedures, which assigns charge codes to different procedures. The retrospective data across the 4 years were compared and analysed.

No patient contact or identifiers were retrieved, stored or disseminated and thus exempt from ethics board review.

Eligibility Criteria:
Inclusion Criteria:

* all patients who underwent gallbladder, hernia, liver or pancreas resection surgeries during the periods of January to June of 2019/2020/2021/2022.

Exclusion Criteria:

* anyone who does not fall within the inclusion criteria
An Open-label Study of Vedolizumab (MLN0002) in Participants With Ulcerative Colitis and Crohn's Disease

The purpose of this multicenter, open-label study is to collect data on the occurrence of important clinical safety events resulting from chronic vedolizumab (MLN0002) administration.

The drug being tested in this study is called vedolizumab. Vedolizumab is being tested to treat people who have ulcerative colitis or Crohn's disease. This study will determine the safety profile of long-term vedolizumab treatment.

The study enrolled 2243 patients. Participants who received either placebo or vedolizumab 300 mg IV infusion every 4 or 8 weeks in previous vedolizumab studies received:

• Vedolizumab 300 mg

All participants received vedolizumab intravenous infusion every 4 weeks for approximately up to 510 weeks.

This multicenter trial is being conducted worldwide. The overall time to participate in this study was up to October 2017 until vedolizumab was available in the country in which the participant resided, or until participant withdrawal, whichever came first. Participants made multiple visits to the clinic up to 16 weeks after receiving their last dose of vedolizumab and were being followed up for 2-years during which a safety questionnaire was administered by telephone for follow-up assessments.

Eligibility Criteria:
Inclusion Criteria:

1. Previous treatment in Study C13004 (NCT00619489), Study C13006 (NCT00783718), Study C13007 (NCT00783692), or Study C13011 (NCT01224171) that, in the opinion of the investigator, was well tolerated OR b. Moderate to severe Crohn's disease or ulcerative colitis which has not been previously treated with vedolizumab (MLN0002)
2. May be receiving a therapeutic dose of conventional therapies for Crohn's disease or ulcerative colitis as defined by the protocol

Exclusion Criteria:

1. Development of any new, unstable, or uncontrolled disease
Hydrogen Sulfide Production by Oral Microflora

Oral malodor is a common condition. In most cases this condition results from the proteolytic activity of anaerobic oral bacteria. These bacteria produce volatile sulfide compounds which are fowl smelling and are felt during exhalation and speech. the aim of the present study is to examine a simple method of detecting these bacteria in samples taken from the oral cavity of oral malodor patients.


Eligibility Criteria:
Inclusion Criteria:

* oral malodor patients

Exclusion Criteria:

* smokers, users of antibiotic one month prior to study
Prophylactic NPWT to Reduce SSI in Colorectal Surgery

The purpose of this study is to see if the Negative Pressure Wound Therapy (NPWT) system is effective and safe for the prevention of superficial and deep incisional surgical site infections (SSI) in high risk patients within 30 days after elective colorectal surgery. It has been shown that patients with an IBD, patients undergoing a reoperation or patients with certain comorbidities are at a higher risk of developing an SSI. The NPWT device is a wound dressing with a vacuum system that can be placed over abdominal wounds. The study will include up to 400 patients at this single site, where these high risk patients will be randomized to receive either one of two arms. The first arm involves the placement of the NPWT device in the immediate postoperative period over abdominal wounds after clean/contaminated colorectal surgical procedures. The device would then be left on for 5 days. The second arm would be standard of care and would entail routine postoperative protocols. Subjects will then be seen once at a 30 day (± 7 days) follow-up visit to assess for the development of SSIs.


Eligibility Criteria:
Inclusion Criteria:

* ages 18-80
* patients who will undergo an open or laparoscopic-assisted clean/contaminated colorectal surgical procedure.
* Patients must either have an inflammatory bowel disease, undergoing reoperation within 30 days, or have two or more of the following risk factors: presence of an ostomy, type II diabetes, BMI greater than 30, immunosuppression, malnutrition, current smoker, chronic kidney disease (creatinine \> 1.2), and disseminated cancer.

Exclusion Criteria:

* patients currently enrolled in another interventional clinical trial,
* patients with a BMI less than 20, patients with a current abdominal abscess or infection (including a known urinary tract infection),
* patients allergic to or hypersensitive to silver, patients planning to undergo a second colorectal surgical procedure (e.g., colostomy or ileostomy takedown) or any other general surgery in less than 30 days of index-surgery,
* any patient in which the planned surgery would include: i) placement of a stoma in the principal incision; ii) placement of a drain into the supra-peritoneal fascia space that emerges through the principal incision; iv) placement of a drain into the intraperitoneal space that emerges through the principal incision; and v) supplementation of any of the irrigation fluid with antibiotic or antiseptic drugs,
* patients with healing disorders,
* pregnant women,
* prisoners, or
* any patient that is deemed unsuitable for the study by the Principal Investigator or the operating surgeon/Co-Investigator.
The European Bifurcation Club Randomized Trial of Stepwise Provisional Stenting Versus Drug Coated Balloon Therapy for Non-left Main True Coronary Bifurcations

Clinical outcomes are worse in patients with coronary artery bifurcation lesions, even if commonly encountered in clinical practice. The use of drug coated balloons within bifurcation lesions offers the acute advantage of a more straightforward procedure, without recrossing and deformation of a stent. Thus, the primary objective of this study is to determine if Drug Coated Balloon treatment of non-left main true coronary artery bifurcation lesions is non-inferior (similar) to a provisional strategy with Drug Eluted Stent deployment.

The EBC DCB study is an investigator-initiated, prospective, multi-centre, open-label, randomized (1:1) non-inferiority trial.

Patients with non-left main bifurcations requiring revascularisation and both the main vessel and side branch significantly diseased ( ≥2.5mm and Medina 1/1/1, 1/0/1 or 0/1/1), constitute the source population. Patients with no more than two additional coronary disease may be considered for the study, with only one bifurcation lesion included.

Patients, pre-selected by their referring physicians, will be screened for eligibility by the study team. If patients fulfill all inclusion and do not meet exclusion criteria, they will be informed about the study's purpose and course and will be asked for participation and written informed consent. 20 sites will be involved, in 7 European countries and South Korea, for a total of 750 patients. After a 2-years recruitment period, the trial will include a Follow-Up period at 6-months, 1-year, 3-years, 5-years and 8-years. The 1-year check point will constitute the primary endpoint where the Bifurcation Orientated Composite Endpoint (BOCE) will be analyzed for non-inferiority (further analysis for superiority, if non-inferiority met).

Eligibility Criteria:
Inclusion Criteria:

* True non-left main bifurcation disease with both MV and SB involvement (i.e Medina 1/1/1, 1/0/1, 0/1/1)
* Bifurcation lesion responsible for an acute or chronic coronary syndrome with at least one of the following:

  * ≥70% angiographic MV and SB diameter stenosis
  * Positive non-invasive testing for ischaemia
  * Positive coronary physiology for ischaemia
* Significant SB as described by diameter stenosis ≥50% and all of the following:

  * SB length ≥73mm
  * SB diameter ≥2.5mm
  * Absence of another SB emerging distally from the MV
  * Non-dominant circumflex artery, if SB is a diagonal branch.

Exclusion criteria

* Patients \<18 years old
* STEMI \<48 hours
* Cardiogenic shock
* Chronic total occlusion involving target bifurcation vessels
* In-stent restenosis
* Patient life expectancy \<12 months
* \>2 other coronary lesions (target or non-target) planned for treatment
* SYNTAX score \>32
* Platelet count ≤50x109/mm3
* Left ventricular ejection fraction ≤20%
* Participation in another investigational drug or device study
* Patient unable to give informed consent