cyrilzakka/clinical-trials huggingface dataset:
Prediction of Future Risk in Patients With Controlled Asthma

The optimal score to predict unfavourable outcome in well-controlled asthma patients who are undergoing a step-wise down-titration of their medication is still lacking. Thus, a study is warranted to prospectively develop a prognostic system -easy to perform (suitable for use in the clinical rather the research setting)- for asthmatic patients in this clinical setting.

HYPOTHESIS: A simple score system can accurately predict clinical deterioration of asthma in well-controlled patients who are undergoing a step-wise down-titration of their medication according to international guidelines.

METHODS The investigators designed a prospective, multicenter, observational study at five centers in cities across Spain.

The patients group (N = 225) will be evaluated to produce a clinical prediction rule for loss of control. The investigators will consider the following variables in the risk factor analysis: documented history of previous bronchial obstruction (FEV1/FVC \< 70%), coefficient of variation (CV) of morning peak expiratory flow (PEF), history of exacerbations, fraction of exhaled nitric oxide (FENO), Asthma control test (ACT), ACT item 3 and adherence.

The score model will be prospectively validated in an independent set of 113 patients.


Eligibility Criteria:
Inclusion Criteria:

* Adults (age between 18 and 80.
* Asthma under control during the last 3 months.
* Treated with a combination of ICS and long-acting beta-agonist (LABA.
* Classified as "moderate asthma" by their attending physician.

Exclusion Criteria:

* Active smoking.
* Pregnancy.
* Treatment with oral corticosteroids, omalizumab or immunotherapy.
Chronic Pain After CS in Egypt

This retrospective study will include Women who will attending to Azhar assuit, Sohag and South valley universities hospitals for any reason in the duration from 1 May to 31 October 2021, and who underwent elective CD under spinal anesthesia with horizontal lower abdominal surgical incision within last two years.

Exclusion criteria will be refusal to participate, age less than 18 years, recent CD (within 3 months), if the infant had died, and history of chronic pain medications or psychiatric disorder.

Data collection

Participants will be contacted personally by one of study authors. Data collected are consisted of:

* Participants' characteristics as Age, parity and ways of delivery, weight, height, residency, husband smoking status, work, previous abdominal surgery, history of diabetes mellitus and hypertension.
* Last CD related data which include presence of multiple pregnancies, if CD was in private/public facility, presence surgical wound infection.
* Pain experienced will be assessed by questionnaire described by Nikolajsen et al, 2004


Eligibility Criteria:
Inclusion Criteria:

* Women attending to Azhar assuit, Sohag and South valley universities hospitals for any reason in the duration from 1 May to 31 October 2021, and who underwent elective ceserean section under spinal anesthesia with horizontal lower abdominal surgical incision within last two years

Exclusion Criteria:

* refusal to participate, age less than 18 years, recent ceserean section (within 3 months), if the infant had died, and history of chronic pain medications or psychiatric disorder
Rainbow R2-25 vs. R1-25 SpHb Sub-Range Performance Equivalence

In this study, the concentration of hemoglobin was measured using noninvasive pulse oximeter sensors and compared against the hemoglobin measurement from the subject's blood sample under controlled conditions. Data collected in the study was in the sub-range of 12-17 g/dL in the device's 8-17 g/dL specification range.

The purpose of the study was to evaluate a change in the sensor component and to assess performance equivalence in the sub-range. The performance of non-invasive hemoglobin is not uniform across the accuracy range.


Eligibility Criteria:
Inclusion Criteria:

* Greater than 18 years old
* Healthy

Exclusion criteria:

* Do not understand the study and the risks involved
* Deemed ineligible by study test personnel
Bioavailability Investigations of Thyronajod Mite Tablets of Dosage Strengths 50 μg Levothyrox-ine/75 μg Iodine, and 100 μg Levothyroxine/75 μg Iodine vs. a Levothyroxine Drinking-Solution: A Randomised Cross Over Study in Healthy Male Individuals. Currently: 100 μg/ 75 μg Tablets

The purpose of this study is to measure the area under the curve (AUC0-48h; extent of systemic availability) and the maxi-mum concentrations (Cmax) of total serum levothyroxine (TT4, bound and free fraction) after a single pharmacological dose of 600 μg administered as tablets also containing iodine supple-ments vs. the same dose of levothyroxine administered as a reference solution without iodine.


Eligibility Criteria:
Inclusion Criteria:

* Euthyroid men
* Age: 18 - 50
* Normal values for fT4 und TSH
* Good state of health

Exclusion Criteria:

* Thyroid function disorders in terms of subclinical or overt hyper- or hypothyroidism
* History of thyroid function disorders
* Focal or diffuse autonomies of the thyroid gland
* Thyroid nodules \>1 ml according to sonographic examination
* Any acute or chronic illness
* Dermatitis herpetiformis
Comprehensive Data Collection and Follow-Up for Patients With Thyroid, Parathyroid and Adrenal Disease

The goal of this data review study is to collect data to learn more about thyroid, parathyroid, and adrenal disease.

If participant or participant's child agrees to take part in this study, information from the medical record will be recorded and entered into a research database at MD Anderson. Researchers will use this data to learn more about participant's or participant's child's current or suspected illness, surgery, and/or recovery as well as participant's or participant's child's medical history.

Length of Study Participant's or participant's child's active participation on this study will be over after 15 years.

Follow-Up Phone Calls Starting about 2-3 years after participant's or participant's child's testing and/or diagnosis and/or treatment and continuing for up to 15 years after participant's surgery, a member of the research team will contact participant by phone to follow up and see how participant or participant's child are doing. The first time participant receives a phone call or are asked in the clinic, participant will be asked for participant's verbal consent for participant or, if this is for participant's child, on behalf of participant's child, to speak to the member of the research team before participant or participant's child are asked any questions. After participant agrees, participant or participant's child will be asked a series of questions related to participant's or participant's child's disease (takes about 20-30 minutes) that ask about participant's or participant's child's current medical status and medical history. Each phone call should take 20-30 minutes to complete.

If participant or participant's child are scheduled for a routine clinic visit around the time of participant's or participant's child's next follow-up phone call, the research team member may talk to participant or participant's child in person at that time, or a questionnaire can be mailed to participant or participant's child if needed.

This is an investigational study.

Up to 15,000 patients will be enrolled in this study. All will be enrolled at MD Anderson.

Eligibility Criteria:
Inclusion Criteria:

1. All patients that are being seen at MD Anderson with diagnosed or suspected endocrine disease. Patients will be selected from patients undergoing evaluation and/or treatment in the Endocrine Center, either by selection from a participating Endocrine physician or by screening from study personnel for patients scheduled to be seen in the Endocrine Clinic.
2. In addition, we intend to contact family members of patients who are enrolled on the study, and found to be deceased at follow-up, to request permission to obtain cause of death, to determine whether cause of death may be related to endocrine disease.

Exclusion Criteria:

N/A
Fish Collagen Peptide Food Supplement on Weight and Body Composition

Fish collagen hydrolysates or peptides orally administered have been investigated in recent clinical trials in human health. These peptides have been evaluated in various biological and medical fields including skin aging, osteoarticular apparatus, muscle and more recently in energy metabolism in both animals and humans.

However, very few studies investigated the effect of fish collagen peptides on weight, body composition or glycemic response. Recently, it has been shown that the consumption of fish collagen peptides (Naticol®) limits weight gain and increase in fat mass in a mouse model made obese by a hyperlipidic diet. Since these results have never been observed in humans, this pilot study proposes to answer this question.


Eligibility Criteria:
Inclusion Criteria:

* Men in overweight (BMI between 25kg/m² and 30kg/m²)
* Aged from 18 and 60 years
* Having signed the informed consent form;
* Susceptible to follow the constraints generated by the study;

Exclusion Criteria:

* Subject treated for type 1 or 2 diabetes, or for any other metabolic disorder (severe dyslipidemia: TG\> 3 g / L and total cholesterol\> 2.5 g / L);
* Subject with untreated and uncorrected high blood pressure;
* Subject with untreated or uncorrected dysthyroidism by drug therapy;
* Subject with a serious general illness that may prevent his or her ability to complete the trial or that could bias the results of the study;
* Subject consuming antibiotic treatment in the month prior to inclusion;
* Subject treated with steroidal anti-inflammatory drugs, anabolic steroids, anticoagulants or corticosteroids;
* Subject knowing allergy to fish or fish collagen;
* Subject taking any dietary supplement or drug that may interact with the results of the study or that could alter the bioavailability of the product under study;
* Subject following or having followed a low-calorie diet (energy intake \<1500 kcal / day) in the 3 months preceding inclusion and / or likely to undertake this diet during the test;
* Subject having lost more than 5% of his initial weight during the last 3 months;
* Subject following a special diet: eg. vegetarian, macrobiotic diet, high protein diet;
* Subject with diagnosed eating disorders (anorexia, bulimia);
* Subject with gastrointestinal malabsorption such as celiac disease, Crohn's disease or lactose intolerance;
* Subject having undergone bariatric surgery;
* Subject with excessive alcohol consumption at more than 3 drinks a day ;
* Subject planning to modify his tobacco consumption (eg weaning) or his level of physical activity (significant increase) before the end of the intervention period;
* Subject having an aversion to the grapefruit aroma;
* Subject unable to understand or adhere to the protocol;
* Subject participating in another clinical study or exclusion period from another study;
The Development of a Patient Reported Outcomes Measure Committed to the Watch-and-wait Program for Rectal Cancer

The purpose of this study to develop an international tool that can be used to assess burden of disease in patients enrolled in the W\&W program for rectal cancer

The watch-and-wait (W\&W) strategy in rectal cancer is a organ-sparing treatment option, where patients with a clinical complete response (cCR) after neoadjuvant chemo(radio)therapy, do not undergo surgery but instead follow a strict follow-up scheme. The goal of the W\&W strategy is to preserve the rectum and thereby retain functional outcomes (FO) (e.g. gastro-intestinal, urinary, sexual) and improve quality of life (QoL).

Patient Reported Outcome Measures (PROMs) reflect the patients' evaluation of their symptoms, FO and QoL. In the W\&W program various PROMs (e.g. EORTC-CR29/C30, LARS, SF-36) are used to assess the these different outcomes. However, most of the PROMs used are developed and validated in a surgical patient group. So the relevance and usefulness of these PROMs may be limited in W\&W patients.

For use in clinical practice, a short PROM would support follow-up care as it provides a clear overview of the problems W\&W patients experience.

This paper describes the protocol for the development of an international tool that can be used to assess burden of disease in patients enrolled in the W\&W program for rectal cancer. We will use the Delphi methodology to reach consensus about items that should be included in the novel tool. The aim of this tool is to improve direct patient care during the entire Watch-and-Wait program.

Eligibility Criteria:
Inclusion Criteria:

* Patients have to be treated with neoadjuvant (chemo)radiotherapy
* Patients are included into the Watch-and-Wait program
* Experts involved in the treatment of rectal cancer
* Experts involved in the Watch-and-Wait program

Exclusion Criteria:

* Regrowth of disease
Reducing Errors In The Neonatal Intensive Care Unit

This is a monocentric prospective pre and post-intervention study, aiming at analyzing the efficacy of the Computerized Provider Order Entry (CPOE) plus Bar Code Medication Administration (BCMA) as compared to paper order entry in reducing medication erros (MEs) in the Neonatal Intensive Care Unit (NICU)

Medication errors are a burden to the health care system. The neonatal population, in particular the infants admitted to the NICU, are at higher risk of MEs as compared to the adult and pediatric population. Moreover adverse events (ADEs) occur more frequently and may be particularly severe in neonates.

Several strategies have been tried in order to decrease the incidence of MEs in the NICU. Among these, some studies investigated the effectiveness of CPOE in reducing MEs in hospitalised patients. However, results have been inconsistent. So far, no study investigated the association of CPOE + BCMA in neonates.

The investigators designed a monocentric prospective pre and post-intervention observational study to investigate the efficacy of the CPOE plus BCMA as compared to paper order entry in reducing MEs in the NICU population.

Eligibility Criteria:
Inclusion criteria:

* Admission to the NICU
* Need of pharmacological intervention
* Informed parental consent

Exclusion criteria:

* Lack of parental consent
Timing of Antihypertensive Medications on Key Outcomes in Hemodialysis

For patients with kidney failure requiring hemodialysis treatment, sometimes the blood pressure will drop too low during dialysis. In an effort to prevent that from occurring, patients are frequently told to skip doses of their blood pressure medications. However, whether this actually prevents blood pressure drops during dialysis, and whether it may cause more uncontrolled high blood pressure is unknown. TAKE-HOLD will study the effect of taking or holding blood pressure medication on blood pressure for patients on hemodialysis.

High blood pressure (BP) is a major modifiable risk factor for cardiovascular disease, and upwards of 90% of patients with end- stage renal disease (ESRD) have high BP. Appropriate BP management, therefore, is a fundamental part of patient care in ESRD, yet the question of when best to take antihypertensive medications relative to the hemodialysis treatment session remains unanswered. Many patients on hemodialysis suffer from an abrupt fall in BP during the dialysis session (i.e., intradialytic hypotension \[IDH\]), a phenomenon that is associated with numerous adverse outcomes. In an attempt to minimize IDH, patients are often told to withhold antihypertensive medications prior to hemodialysis, and current guidelines suggest taking antihypertensive medications at night to minimize IDH. However, there are no data regarding the safety of these antihypertensive medication timing strategies, or whether these strategies are effective in reducing IDH.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. On in-center thrice weekly hemodialysis
3. Dialysis start time in the morning
4. Taking at least one antihypertensive medication

Exclusion Criteria:

1. Initiation of hemodialysis within previous 90 days
2. Inability to provide informed consent
3. Currently participating in another clinical trial (intervention study)
4. \>2 unexcused missed dialysis sessions in the previous 30 days
5. Documented heart failure with reduced ejection fraction (left ventricular ejection fraction \< 40%)
6. Cardiovascular event (e.g. myocardial infarction, stroke, heart failure) or procedure (e.g., coronary artery bypass, peripheral arterial bypass grafting, carotid artery procedures, aortic procedures) or hospitalization for unstable angina within the previous 90 days
7. End-stage liver disease
8. Planned kidney transplant within the next 90 days
9. Planned dialysis modality switch (to home hemodialysis, peritoneal dialysis, nocturnal hemodialysis) within the next 90 days
10. Pregnancy, currently trying to become pregnant
11. Active infection requiring antibiotic, antifungal or antiviral therapies
12. Any factors judged by the treatment team to be likely to limit adherence to the interventions

    1. Active alcohol or substance abuse within the last 12 months
    2. Plans to move outside of the treatment area within in the next 90 days
    3. Other medical, psychiatric, or behavioral factors that in the judgement of the study team may interfere with study participation or the ability to follow the intervention protocol
MediBeat - HeartBeat Observation Trial

The goal of the study was to compare the current gold standard blood pressure instrument (a mercury-filled sphygmomanometer with cuff and stethoscope) with the new experimental algorithm developed by HeartBeat Technologies Ltd. To that end, participants were recruited from Markham, Ontario and participated in a series of alternating blood pressure measurements over a period of 45 minutes. Comparisons were made between manual measurements and device measurements to determine the quality of the device readings. Measurements were taken by trained nurses and staff were consistent across the study duration.

The gold standard instrument for blood pressure measurement is a mercury-filled sphygmomanometer with cuff and stethoscope (Canadian Agency for Drugs and Technologies in Health; Canadian Electronic Library, 2012). However, such a device is not the most convenient for client self-monitoring or virtual (remote) care. Thus, there is a desire for an accurate, reliable alternative for the traditional mercury-containing sphygmomanometer.

HeartBeat Technologies Ltd. ("Heartbeat") has developed a novel approach to measuring blood pressure after an initial blood pressure reading using the conventional measurement method, supplemented by specific characteristics of a person (age, gender, height, weight, and heart rate), has established a "baseline measurement" for the person. The "novel approach" uses a finger pulse oximeter, the Contec CMS50EW device (Figure 1) (manufactured by Contec Medical Systems Co., Ltd., Shanghai, People's Republic of China). The finger pulse oximeter detects the changes in blood volume directly below the person's skin and indirectly measures oxygen saturation in the blood. The measurement is in the form of a photoplethysmogram (PPG) which is captured by the Contec oximeter and then, by Bluetooth technology, transmitted to a smartphone or tablet. A HeartBeat application, called MediBeat, on the smartphone or tablet then transmits the PPG to a server where a proprietary algorithm analyzes the baseline measurement for the person and the PPG to calculate the person's current blood pressure.

Heartbeat's intent is that the current blood pressure reading would then be made available to both the client and the health provider through separate web-based interfaces. Providers would be able to log onto the HeartBeat web-based application from anywhere to review and monitor the blood pressure of multiple clients, while clients can log onto the application to track their own measurements.

Eligibility Criteria:
Inclusion Criteria:

* adult over 25 years of age

Exclusion Criteria:

* those who have heart arrhythmias,
* atrial fibrillations or atrial flutters,
* an inaudible Korotkoff sound,
* wounds of the upper arms/wrists, missing fingers, and/or
* an arm circumference of more than 55 cm will be excluded
Safety, Pharmacokinetics, and Preliminary Efficacy of BYON4413 in Acute Myeloid Leukemia and Myelodysplastic Neoplasms.

This is the first-in-human trial with BYON4413 to evaluate safety, PK, immunogenicity, and anti-leukemia activity of BYON4413 in patients with AML or MDS.

This trial includes two parts. Part 1 is a dose escalation study in which the maximum tolerated dose and recommended dose for expansion of BYON4413 will be determined. Part 2 is an expansion study to evaluate the anti-leukemia activity and safety of BYON4413.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have progressed on standard therapy or have no established alternative treatment, with a diagnosis of:

  * R/R AML (WHO 2022) OR
  * MDS (WHO 2022) with ≥10% blasts in BM and have received ≥3 cycles of HMA
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2;
* Adequate baseline organ function.

Exclusion Criteria:

* Having been treated with any CD123-targeting therapies;
* Having received allogeneic hematopoietic stem cell transplantation within 100 days prior to start Cycle 1 Day 1;
* Having treatment-related toxicities from prior anti-leukemia therapies that have not resolved to CTCAE Grade ≤ 1;
* Having active central nervous system AML or AML of the APL/M3 subtype;
* History of keratitis;
* History of specified lung or renal disease;
* Having clinically significant cardiovascular disease;
* Known infection of Hepatitis B, C or E.

Key inclusion and exclusion criteria details are listed here, additional requirements may apply.
Long-Term Innohep® Treatment Versus a Vitamin K Antagonist (Warfarin) for the Treatment of Venous Thromboembolism (VTE) in Cancer

The purpose of this study is to assess the efficacy and safety of Innohep® in preventing the recurrence of VTE in patients with active cancer who have had an acute VTE episode.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of active cancer.
* Symptomatic and objectively confirmed VTE.
* ≥ 18 years of age or above the legal age of consent as per country specific regulations.
* Patients with Eastern Co-operative Oncology Group (ECOG) performance status of 0, 1 or 2.
* Signed informed consent.

Exclusion Criteria:

* Life expectancy \< 6 months.
* Patients with basal cell carcinoma or non-melanoma skin cancer.
* Creatinine clearance ≤ 20 ml/min.
* Contra-indications to anticoagulation.
* Known hypersensitivity to the investigational product (Innohep®) or the reference product (warfarin).
* History of heparin-induced thrombocytopenia (HIT).
* Pre-randomisation therapeutic anticoagulant treatment for acute VTE administered for more than 72 hours prior to randomisation.
* Patients unlikely to comply with the protocol.
* Participation in another interventional study.
* Pregnant or breast-feeding women.
* Women of childbearing potential.