cyrilzakka/clinical-trials huggingface dataset:
An Extension to Study AZA PH GL 2003 CL 001 Allowing for Continuation of Azacitidine Treatment in Patients With Myelodysplastic Syndromes (MDS)

At the conclusion of study AZA PH GL 2003 CL 001 (NCT00071799), eligible participants could be enrolled in an optional extension phase in order to continue treatment with azacitidine until it became commercially available; the continued treatment was for ethical and safety reasons only and not to provide additional efficacy data.

At the conclusion of study AZA PH GL 2003 CL 001 (NCT00071799), eligible participants could be enrolled in an optional extension phase in order to continue treatment with azacitidine until it became commercially available; the continued treatment was for ethical and safety reasons only and not to provide additional efficacy data.

During the extension phase, participants were treated based on 28-day cycles and monitored for hematologic, nonhematologic, and renal toxicities. Recommended monitoring procedures included complete blood count with differential and platelets at least once each cycle prior to dosing and as needed, bone marrow biopsy and aspirate as clinically indicated, and additional tests or more frequent monitoring at the investigator's discretion based on the patient's clinical status. The azacitidine dose could be modified for toxicities. Laboratory data were not collected during the extension phase.

Eligibility Criteria:
Inclusion Criteria:

* Participants were considered eligible if they had been randomized to azacitidine treatment in the primary study and were receiving azacitidine at the time of study closure, had completed 12 months of treatment and observation in the primary study, and had signed the informed consent document for the extension phase of the study.
* See study: AZA PH GL 2003 CL 001 for a list of inclusion criteria for the primary study.

Exclusion Criteria:

* None specific to the extension phase of the study
* See study: AZA PH GL 2003 CL 001 for a list of exclusion criteria for the primary study.
Concurrent Training and Nutritional Management in Cancer

A case control study with before-after design. A concurrent training and a nutritional management intervention was offered by a patient with head and neck cancer, in order to compare outcomes related to strength and endurance performance and to body composition

Cancer causes important public health problems around the world and it is one of the most frequent cause of death overall. Among non-pharmacological treatment, physical exercise has shown improvements in different types of cancer and patients, but it is important to define the optimal dose. Our aim is to determine the effects of a concurrent training program and a nutritional management developed during radiotherapy treatment on physical performance and body composition. A patient with an oral cavity cancer will develop three sessions per week of concurrent training: resistance training included 9 standard exercises involving major muscle groups (4x8-12 RM), and cardiovascular training included a High-Intensity Interval Training (HIIT). Nutritional management will include a diet controlling macronutrients (\~4g/kg/day for carbohidrates, \~2g/kg/day for proteins, and \~1g/kg/day for fats), along with some nutritional supplements such as beta-hydroxybeta-methylbutyrate (HMB), arginine, glutamine, omega-3 fish oil concentrate, and BCAA's during training sessions. Intervention took place during radiotherapy period (7 weeks). We expect that body composition will remain invariable, and 1RM will increased. VO2max is expected to be almost the same, but intensity tolerated at maximum VO2max could be higher. If our results confirm that, we could conclude that a combination between resistance exercise and HIIT along with a nutritional management developed during radiotherapy could be effective to prevent muscle mass loss and muscle function decrease in a young patient with oral cavity cancer.

Eligibility Criteria:
This is a case control study
Health Related Quality of Life in Functional Dyspepsia

Previous studies reported health related quality of life impairment in functional dyspepsia patients. Anxiety, depression, disease severity, age, and employment status associated with HRQOL in functional dyspepsia patients. However, data about HRQOL in Asian population was limited.This study aimed to evaluate factors associated with health related quality of life in patients with functional dyspepsia.

126 functional dyspepsia patients will answer SF-36 HRQOL questionnaire, Hospital Anxiety, and Depression Scale, and Short Form Nepean Dyspepsia Index. Functional dyspepsia and Irritable Bowel Syndrome Rome III diagnostic questionnaire and GERD-Q questionnaire will be used to determine FD type and IBS or GERD overlap.

Eligibility Criteria:
Inclusion Criteria:

* Dyspepsia patients
* Normal or non ulcer esophagogastroduodenescopy finding

Exclusion Criteria:

* History of GI bleeding
* History of GI malignancies
* Hepatobiliary tract disease
* Diabetes mellitus
* Chronic kidney disease
The Antipyretic Efficacy of Oral and Intravenous Paracetamol and Intramuscular Diclofenac in Patients Presenting With Fever.

A randomized clinical trial to check the antipyretic efficacy of oral and intravenous paracetamol and intramuscular diclofenac sodium in patients presenting with fever to emergency department.


Eligibility Criteria:
Inclusion Criteria:

* Adults between the age of 14-75 years with an oral temperature of more than 38.5 C

Exclusion Criteria:

* History of allergy to any of the drugs in the study
* Had taken antipyretics within 8 hours
* Renal, hepatic or haematological disorders
* bronchial asthma, peptic ulcer disease, vomiting
* Pregnant or lactating women
Increasing Uptake of Colorectal Cancer Screening in Ontario

The investigators hope to determine whether the addition of an FOBT kit and educational materials to a second mailed invitation compared to a second mailed invitation alone increases use of appropriate screening tests (FOBT for average risk or colonoscopy if increased risk) by eligible persons within 6 months of the second mailing in: (1)Non-responders to an initial mailed CRC screening invitation from their family physician and, (2)Those who responded to the initial mailed CRC screening invitation and are due for repeat screening (i.e., "recall" patients). In addition, the investigators will also explore the impact of the investigators intervention in likely under-screened groups such as those living in more remote areas of the province and those with low socio-economic status as well as assessing the cost-effectiveness of this strategy.


Eligibility Criteria:
Inclusion Criteria:

* Recipients of a mailed CRC screening invitation through the CCO Invitation Pilot project
* No OHIP record of completion of FOBT since initial mailing (Non-responders arm only)
* No OHIP of 'CRC Cancer Screening Exclusion' tracking code since initial mailing (Non-responders arm only)
* An OHIP record of completion of FOBT 6 months since initial mailing (Recall arm only)
* Negative result according to LRT or if not in LRT, no record of interval colonoscopy in CIRT or OHIP (Recall arm only)

Exclusion Criteria:

* Age greater than 74 years at time of mailing
* Interval diagnosis of colorectal cancer
* Interval colonoscopy or flexible sigmoidoscopy
* Interval departure from Pilot physician's practice
* Death
* Presently institutionalized
* Physician has declined participation in the study
* Interval record of repeat FOBT (Recall arm only)
Night Balance for Positional Obstructive Sleep Apnea Syndrome (POSAS)

POSAS can be treated with CPAP however there is now evidence from a few studies that Night Balance is effective in POSAS. Night Balance seems to be better accepted than CPAP so we would like to examine if we could find similar results in routine clinical work and especially we would like to confirm the subjective effects with objective measures i.e. a reduction in AHI in the supine position during sleep.

Primary aim: Efficacy and adherence of Night Balance in POSAS versus no therapy after 2 months (Sleep supine).

Secondary aim: Efficacy and adherence of Night Balance in POSAS after a 6 months period (Sleep supine and compliance and AHI).

Nigh Balance is a vibrator and a belt that vibrate when laying supine so that after a few days you will not sleep supine.

Eligibility Criteria:
Inclusion Criteria:

* AHI supine ≥ AHI non-supine x 2,
* AHI supine ≥ 10
* AHI non-supine \<10
* 10 -90 % sleep time in supine position
* Daytime tiredness and/or disturbed sleep and/or snoring

Exclusion Criteria:

* Not able or willing to cooperate
* Age \<18 years
* Central Sleep Apnea
* Night or shifting work
* Severe chronic heart failure or severe COPD
* A medical history of known causes of tiredness by day or severe sleep disruption (insomnia, PLMS, Narcolepsy)
* Seizure disorder
* A known medical history of mental retardation, memory disorders or psychiatric disorders
* The inability to provide informed consent
* Pacemaker
* Pain in joints or shoulder
* Other reasons unable to sleep in lateral positions.
* Pregnant females or females that plan pregnancy in study period (problems sleeping supine)
* Breastfeeding females in study period (other reasons for disturbed sleep)
* Plan weight reduction in study period
* Plan to quit smoking in study period
Impact of Chronic Rhinosinusitis on the Index of Ciliary Beat Efficiency Using Fluorescent Nanosticks: (R-IMPAC)

Impact of chronic rhinosinusitis on the index of ciliary beat efficiency using fluorescent nanosticks

To date, the assessment of ciliary beat is only possible ex vivo on epithelial cells obtained from upper airway brushing. A previous prospective study (I-IsBac) showed a change in ciliary beat (in terms of coordination and frequency) in bacterial rhinosinusitis. The study of ex-vivo ciliary movement appears to be an interesting tool to understand the pathophysiology of CSRs and to guide and evaluate treatment.

A new tool to evaluate the effectiveness of the ex-vivo lash beat has been developed. This tool measures shear stress by tracking balls along the ciliary margin.

This measurement of ex-vivo shear stress by bead tracking is a validated technique. However, microbead tracking is limited by its low spatial and temporal resolution, long measurement time and heavy post-processing of acquisition data, making this method difficult to use in clinical routine. Monitoring ex-vivo fluorescent nano-batons could represent a simpler alternative for the clinician. This measurement is now made possible by Phosphate Lanthanum Lanthanum Nano-batons (LaPO4) whose luminescence is directly proportional to the shear.

The objective of this research project is to validate this new tool in patients with CSR by comparing it to a group of control subjects free of nasal inflammation.

Eligibility Criteria:
Inclusion Criteria:

1. Patient ≥ 18 years old

   * Having chronic rhinosinusitis (RCS) requiring surgical treatment. Or
   * With an indication for endonasal surgery for nasal obstruction (turbinoplasty and septoplasty) or for an endonasal surgical approach
2. Acceptance to participate in the protocol with signed informed consent
3. Affiliated or beneficiary of a social security scheme

Exclusion Criteria:

1. Refusal to participate in the study
2. No one who does not speak or understand French
3. Pregnant or breastfeeding woman
4. Persons who are incapable of reaching the age of majority, under guardianship, guardianship or protection of justice.
5. Simulated participation in another intervention research
The Important Project of Obese Pregnant Women

Obesity is a globally growing public health problem. In 1993, about 25% of women in Sweden were overweight (BMI over 25) or obese (BMI over 30) on the first visit to maternal health care. Twenty years later, in 2013, the corresponding proportion was 38%. Being fat increases the risk of several severe complications during pregnancy and childbirth, such as miscarriage, premature birth, congenital disabilities, intrauterine fetal death, thromboembolism, gestational diabetes, pregnancy-induced hypertension.

Purpose of the project: To assess whether the introduction of new guidelines for overweight pregnant women (BMI\>35) affects the outcome of pregnancy and childbirth, such as the frequency of cesarean sections or labor inductions.

A prospective cohort study involving all women with a BMI \>35 who give birth at the women's clinic, Soder Hospital, Stockholm, between 2019-2023. New guidelines for this group are being developed using NICEguidelines (UK) as a model and will be tested in clinical practice.

Information from births will be collected from medical files. The information will be handled on a group basis.

Internationally, there are guidelines for how pregnancy should be handled when a woman has a high BMI. This is currently lacking in Swedish maternity care. These international guidelines have now been translated and adapted to Swedish conditions and will be tested for a 2 year period at the women's clinic.

Eligibility Criteria:
Inclusion Criteria:

* : Pregnancy where the woman has a BMI\>=35 when enrolling to prenatale care

Exclusion Criteria:

* Pregnant women with BMI\<35
Comparison of the Effects of Weight Changes on Serum Adipokines in Patients Diagnosed With Anorexia Nervosa and Morbid Obesity

In this study, when patients diagnosed with AN started treatment and their weight increased by 10%; On the other hand, it was aimed to compare the changes in serum adipokine levels observed in morbidly obese patients before bariatric surgery and when they lost 10% of their post-op weight with both anthropometric measurements, biochemical parameters, and values of healthy volunteers.

The most characteristic feature of obesity is the increase in adipose tissue. On the contrary, in anorexia nervosa, there is a decrease in adipose tissue enough to impair neuroendocrine functions. Adipose tissue is formed by loosely binding lipid-filled cells called adipocytes and is now considered an important part of energy metabolism. Adipokines it secretes play a role in many physiological processes of the body such as nutrition, appetite, energy balance, insulin, and glucose metabolism, lipid metabolism, regulation of blood pressure, vascular remodeling, coagulation, and inflammation.

Therefore, changes in the amount of body fat in these two patient groups, which are at the two ends of the spectrum, affect both the biochemical parameters and physiological functions of the patients in different ways. It is expected that both adipokine levels and biochemical parameters will approach the values of healthy subjects with a decrease in adipose tissue of clinically morbidly obese patients and an increase in adipose tissue of patients with AN. However, in some studies comparing the parameters of patients with constitutionally weak patients and patients with AN, results contrary to expectations were obtained. In this study, we compared the extent to which weight changes changed adipokines and correlated with biochemical parameters based on healthy and normal-weight volunteers.

Eligibility Criteria:
Inclusion Criteria:

* for Anorexia Nervosa group:

  * Have been diagnosed with anorexia nervosa
  * BMI \<18 kg/m2
  * Good general health
  * Volunteering to participate in the study
* for Morbidly Obese group:

  * Who was diagnosed with morbid obesity and planned to undergo RYGB operation
  * BMI\> 40 kg/m2
  * Volunteering to participate in the study
* for Healthy Volunteers:

  * Good general health
  * BMI \>20 and \<30 kg/m2
  * Volunteering to participate in the study

Exclusion Criteria:

* \<13 and\> 60 years old
* to had type 2 diabetes, hypertension, liver and kidney failure, cancer, or a chronic disease
Dasatinib for Patients Achieving Complete Molecular Response for Cure D-NewS Trial

The purpose of this study is to assess whether dasatinib can be discontinued without occurrence of molecular relapse in patients with chronic myeloid leukemia in chronic phase in complete molecular remission(CMR) while on dasatinib.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed Chronic Myeloid Leukemia in the Chronic Phase
* 15 years old over.
* ECOG performance status (PS) score 0-2.
* Adequate organ function (hepatic, renal and lung).
* Signed written informed consent.

Exclusion Criteria:

* A case with the double cancer of the activity.
* Women who are pregnant or breastfeeding.
* female patient who there is not intention with an appropriate sterilization, or cannot use it during a study entry period
* Patients with complications or a history of severe or uncontrolled cardiovascular failure following have a Myocardial infarction within 6 months have an Angina within 3 months have a Congestive heart failure within 3 months have a QTc interval of more than 450msec at baseline
* A serious uncontrolled medical disorder that would impair the ability of the subjects to receive protocol therapy
Sonazoid Enhanced Liver Cancer Trial for Early Detection

The aim of this study is to prove usefulness of contrast-enhanced ultrasound (CE-US) using Sonazoid (TM) in the early detection of HCC as compared with conventional B-mode ultrasound (B-mode US) for hepatitis virus related cirrhosis, who are defined as super high-risk patients for hepatocarcinogenesis,Furthermore, to analyze whether early detection of HCC by CE-US has a survival benefit than that by B-mode US.


Eligibility Criteria:
Inclusion Criteria:

1. Age over 20
2. HBV or HCV related liver cirrhosis
3. No history of HCC
4. Diagnosed as liver cirrhosis histologically or clinically Histologically confirmed by liver biopsy Confirmed by formula of diagnosing cirrhosis Radiological finding Finding of portal hypertension Platelet\<130,000
5. Inpatient or outpatient
6. Patients who signed a written informed consent form

Exclusion Criteria:

1. History of hypersensitivity to egg yolk
2. Pregnant or lactating women and women who may be pregnant
3. Severe liver dysfunction(AST, ALT,or BIL level \>10ULN
4. Associated with HCC
5. Patients receiving interferon
6. Age under 20
7. Judged by investigator not to be appropriate for inclusion in this study
Managed Problem Solving for ART Adherence and HIV Care Retention Delivered by Community Health Workers

The Managed Problem Solving (MAPS) behavioral intervention is an EBP for behavior change in people living with HIV (PLWH). The investigators propose that MAPS can be delivered by trained Community Health Workers (CHWs). The use of CHWs to deliver MAPS is justified by their ability to develop trusting relationships with their clients and the need for task shifting in busy clinics. In order to also address retention in care, the investigators will adapt MAPS to also focus on problem solving activities tailored toward retention in care (now termed MAPS+). CHWs will be located in clinics to implement MAPS+ to improve viral suppression and care retention in PLWH. Data-to-care allows for identification of people who are lost to care and link these patients back to care. Currently, medication adherence and retention in HIV care are not targeted in data-to-care so the investigators will build on this approach to facilitate the identification of PLWH who are out of care and not virally suppressed to offer them MAPS+. The set of implementation strategies include task-shifting the delivery of MAPS+ to CHWs, providing the CHWs training and ongoing support, and increasing communication between the CHWs and medical care team via standardized protocols. The investigators will conduct a hybrid type II effectiveness-implementation trial with a stepped-wedge cluster randomized design in 12 clinics to test MAPS+ compared to usual care using a set of implementation strategies that will best support implementation. Each clinic will be randomized to one of three implementation start times. Baseline (usual care) data will be collected from each clinic for 6 months, followed by MAPS+ and the package of implementation strategies for 12 months, in three cohorts of 4 clinics each. Aim 1 will test the effectiveness of MAPS+ on clinical effectiveness outcomes, including viral suppression (primary) and retention (secondary). Aim 2 will examine the effect of the package of implementation strategies on reach. Implementation cost will also be measured. Aim 3 will apply a qualitative approach to understand processes, mechanisms, and sustainment of the implementation approach. The results will guide future efforts to implement behavioral EBPs across the HIV care continuum, consistent with the "treat" pillar of EHE, and move the science of implementation services, consistent with NIH strategic priorities.


Eligibility Criteria:
Inclusion Criteria:

* age 18 or older
* a man or woman living with HIV
* not retained in care and/or virally suppressed in year prior to trial initiation

Exclusion Criteria:

- incarcerated during the duration of the trial
Evaluation of 3D Translabial Ultrasound Imaging for Pessary Size Estimation

Symptoms of female pelvic floor dysfunction, such as incontinence and pelvic organ prolapse, can be alleviated by using pessaries, which are passive medical devices that are inserted in the vagina to support the pelvic organs. Currently, pessaries are fit through trial and error after manual examination, the accuracy of which depends on the physician's expertise level.

The objective of this study is to evaluate the feasibility of using 3D translabial ultrasound imaging of the vagina at various distension volumes to predict the pessary size for successful fit. Ultrasound images will be obtained using commercially available 3D ultrasound probes (Philips, Netherlands), as well as a commercially available 2D ultrasound probe (Philips, Netherlands), which is linearly scanned to capture a 3D volume. The linear scanning will be performed by attaching the 2D probe to a motorized hand-held scanner, which is used to tilt and move the probe to acquire images. Please note that the hand-held scanner does not come in contact with the patient. To distend the vagina, a sterile bag is inserted in the vagina and gradually filled with water using a commercially available urodynamic system (Laborie, Canada) until the vaginal capacity is reached, without causing any discomfort to the patient. This image acquisition technique, previously reported in the literature, is referred to as 3D ultrasound vaginal manometry in this study.

To achieve the objective of this project, 35 pelvic organ prolapse patients, who (i) are current pessary users, (ii) can perform self-care of the pessary, and (iii) can provide informed consent, will be invited to participate in the study. Patients will be asked to remove their pessary prior to ultrasound imaging. Then, 3D ultrasound vaginal manometry will be performed, using the technique described above. Ultrasound images will be analyzed once data acquisition is completed. The size of the pessary estimated from ultrasound images will be compared with the actual pessary size used by the patient.


Eligibility Criteria:
Inclusion Criteria:

* Current pessary users (\> 6 months) who have no pessary related complication, including discomfort, repeated vaginal bleeding, and pessary extrusion
* Are able to provide informed consent
* Can perform self-care, i.e. removing and inserting the pessary themselves
* Are willing to remove their pessary 2 days before the ultrasound examination date.

Exclusion Criteria:

* Inability to give informed consent
* Inability to communicate with the person performing the consent and the sonographer performing ultrasound scanning
* History of pelvic radiation or surgery, (including hysterectomy)
* Using pessaries other than ring, incontinence dish, donut, Shaatz, Marland, or Gellhorn.
* Inability to perform the Valsalva maneuver or pelvic floor contraction
* Restricted mobility that prevents them from ambulating to assess the comfort level of the pessary during the initial pessary fitting visit.
* Lack of sensation at the pelvic floor.
* Being pregnant at the time of the examination.