cyrilzakka/clinical-trials huggingface dataset:
Ampholipad Real-World Data in Taiwan

A retrospective, post-marketing, multi-center chart review study includes patients who had been prescribed Ampholipad.

A retrospective, post-marketing, multi-center chart review study includes patients who had been prescribed Ampholipad in selected sentinel hospitals in Taiwan. Medical charts of approximately 100 treated patients will be reviewed by the investigators to collect the pre-specified data, including indication, underlying cancer type (only for cancer patients), demographics, and concomitant medications as well as all the laboratory examination data regarding renal function from 1 month prior to first dose of Ampholipad up to 1 week after the last dose of the initial treatment course.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female ≥ 2 years of age
2. Patients who had received at least one dose of Ampholipad treatment, with available baseline serum creatinine (SCr) data within 1 month prior to first Ampholipad use and at least one post baseline SCr data during treatment period

Exclusion Criteria:

1. Patients whose medical chart cannot provide both the start and stop dates of Ampholipad for a course of treatment (first course only)
2. Patients who had documented HIV infection diagnosis
3. Patients with potential end-stage renal disease (ESRD) receiving regular dialysis within 1 month prior to first Ampholipad use
Safety of Mesh Used Repairs in Emergency Abdominal Wall Hernias. Prospective Randomized Multicenter Trial

Repairing of emergency (strangulated) abdominal wall hernias with mesh may cause infective complications.

Repairing of emergency (strangulated) abdominal wall hernias with mesh is controversary. Strangulated abdominal hernias are not clean surgical wounds so applying prostetic materials such as meshes are problematic. Using of prostetic materials in un-clean wounds (clean contaminated, contaminated and dirty) is not proposed. But in surgical practice meshed surgical repair techniques are using largeley. In this multicenter study we try to find the answer for emergency hernia repairs meshed or not.

Eligibility Criteria:
Inclusion Criteria:

1. Older than 16 years old,
2. Strangulated abdominal wall hernia
3. No any contrindications to operation

Exclusion Criteria:

1. Younger than 16 years old,
2. Non-strangulated abdominal wall hernis
3. Any causes of contrindications to operation
Novel Medical Device for Pharmacological Therapy

Background: Different co-creation methods were used to design and prototype a new fixative device for multiple intravenous therapies with the ability to control and identify the pharmacological therapy administered to a patient. Objectives: To validate a newly created device for the reduction of complications related to the use of intravenous therapy Methods: A multidisciplinary team composed of eight professionals specializing in the field of critical care and an engineering professional in industrial design was responsible for collecting, evaluating, and materializing the ideas and needs arising from clinical practice in a device that met the standards of the same.


Eligibility Criteria:
Inclusion Criteria:

* patients admitted to the intensive care unit
* patients with authorization to take part in the study

Exclusion Criteria:

* Patients with pre-existing medical conditions: Patients with diseases affecting coagulation, such as hemophilia or thrombocytopathies, could be excluded.
* Active infection patients: Any patient with vascular access site infections or systemic infections may be excluded to avoid complications.
* Inability to give informed consent: Patients who are unable to understand or consent to participate in the study.
Post-market Observation of a Wireless Vital Sign Monitor for Hospitalized Newborns in Kenya

The goal of this study is to measure the clinical impact and cost-effectiveness of a wireless vital signs monitor, neoGuard, for hospitalized newborns at a tertiary healthcare facility in Kenya. The main questions it aims to answer are:

1. Does the neoGuard vital signs monitor detect meaningful vital sign changes in hospitalized newborns?
2. Does the neoGuard vital signs monitor generate valid signals to trigger a timely response from nurses?
3. Is the neoGuard vital signs monitor associated with improved patient outcomes and lower mortality?
4. What is the cost-effectiveness of the neoGuard vital signs monitor in comparison to the standard-of-care monitoring system? Participants will be enrolled within the first 24 hours of admission and monitored for a period of 7 consecutive days or until they are discharged (whichever comes sooner).

The study will consist of an intervention group and a comparison group. Researchers will compare nurses' response time to patients in distress, newborn complication rates and treatment outcomes between the two groups.

This is an interrupted time series study conducted at the Moi Teaching and Referral Hospital (MTRH) neonatal ward between April 2022 and June 2023. Our study participants comprise of newborn patients admitted at MTRH during that period. The MTRH neonatal ward is arranged in 8 sub-units which comprise our comparison sub-groups. Newborns admitted from April-November 2022 comprise the pre-intervention arm and are not exposed to neoGuard, but receive existing standard-of-care vital sign monitoring.

In December 2022, neoGuard was installed in 4 sub-units (intervention group), while the remaining 4 sub-units (comparison group) continued to use standard-of-care monitoring.

The measurement of effectiveness will be performed at three levels: (1) device's ability to detect abnormal physiological signals and provide alerts/alarms that notify the nurses to check on a patient's status and; (2) alarms/alerts from level one that resulted in a necessary intervention being administered to the patient (valid alarms), versus all the alarms/alerts that did not necessitate an intervention (invalid alarms); (3) the month-to-month difference in newborn complication rates and treatment outcomes between the intervention group and comparison group.

Medical staff who interact with neoGuard will participate in user surveys at the end of the intervention period to capture user experience and perceptions on feasibility and sustainability.

Eligibility Criteria:
Inclusion Criteria:

* Must be admitted to one of the subunits assigned to receive the intervention (i.e., APU category A or B, the HDU-1 or HDU-2)
* The newborn's parent/guardian must provide informed consent to use the neoGuard system on their newborn.

Exclusion Criteria:

* Assessed to have congenital anomalies that are incompatible with life
* Receiving palliative care
* Patients undergoing phototherapy
* Those with open head injuries/lacerations
* Those receiving treatment that might interfere with application of the neoGuard device
Comparing Immune Responses to Topical Imiquimod

The study is a basic science research study that is designed to characterize and compare the immune response in individuals who are designated as ABO blood group secretors, meaning they have a functional copy of the FUT2 gene versus those patients who are designated ABO non-secretors after application of topical imiquimod to these patients.


Eligibility Criteria:
Inclusion Criteria:

* Individuals between 18 to 85 years of age
* Patients with a diagnosis that will result in treatment with imiquimod as standard of care, specifically actinic keratosis

Exclusion Criteria:

* Younger than 18 years or older than 85 years.
* History of hypersensitivity/ allergic reaction or adverse reaction to imiquimod
* Individuals with a diagnostic biopsy and supportive histology of a cutaneous immune-mediated disease (e.g. psoriasis and mycosis fungoides, etc.) or diseases of the hematopoietic system, liver and the gastrointestinal tract (e.g. aplastic anemia, Crohn's disease, Ulcerative Colitis, Primary Sclerosing Cholangitis (PSC), Primary Biliary Cirrhosis, acute and chronic graft versus host disease (GVHD)).
* Individuals with autoantibodies plus objective evidence of end organ damage related to a cutaneous immune-mediated disease (e.g. psoriasis and mycosis fungoides, etc.) or diseases of the hematopoietic system, liver and the gastrointestinal tract (e.g. aplastic anemia, Crohn's disease, Ulcerative Colitis, Primary Sclerosing Cholangitis (PSC), Primary Biliary Cirrhosis, acute and chronic graft versus host disease (GVHD)).
* Individuals with a history of serious infection within the last 6 months.
* Individuals with tuberculosis, HIV, or hepatitis B, or C.
* Patients unable to provide consent
* Incarcerated individuals
Cytokines Supplementation to Culture Media and ICSI Outcome

A randomized clinical trial to evaluate the effect of cytokine supplementation in embryo culture medium with various protein concentrations aiming to evaluate the effects of cytokines (CYK) integration into the human in vitro culture medium with high and low human serum albumin (HSA) concentrations on live birth rates after intracytoplasmic sperm injection (ICSI).

Oocytes were injected, and embryos cultured and transferred in three supplemented culture media.

A- A single step culture medium (SSCM; Global, Life Global)+5mg/ml (10% Vol/Vol), life global protein, without supplementation of CYK (control n=200), B- A single step culture medium (SSCM; Global, Life Global)+5mg/ml (10% Vol/Vol), life global protein, with 2ng/mL GM-CSF (granulocyte macrophage colony stimulating factor) (G5035 Sigma), 5ng/mL HB-EGF (Heparine Binding Epidermal Growth Factor )(E4643 Sigma),and 5ng/mL LIF (Lukemia Inhbitory Factor) (SRP9001 Sigma)(n=200).

C- A single step culture medium (SSCM; Global, Life Global) +2mg/ml (5% Vol/Vol) life global protein, with 2ng/mL GM-CSF (G5035 Sigma), 5ng/mL HB-EGF (E4643 Sigma), and 5ng/mL LIF (SRP9001 Sigma).(n=200) Setting :- - Mansoura Integrated Fertility

Eligibility Criteria:
Inclusion Criteria:

* Patients who fitted the medical definition of infertility "One year of unprotected intercourse but not pregnant".

Exclusion Criteria:

* History of ovarian or adnexal surgery.
* Suspicious findings of ovarian malignancy.
* Presence of endocrine disorders such as diabetes mellitus, hyper-prolactinemia, thyroid dysfunction, congenital adrenal hyperplasia, Cushing's syndrome, and adrenal insufficiency.
* Presence of Globozoospermia (100% round-headed spermatozoa)
Effects of Long Term Calorie Restriction on Sphingomyelin and Amino Acids

The effect of weight loss with long-term low calorie diet (LCD) on plasma metabolites is unknown. The aim was to examine whether a LCD-induced weight reduction results in changes in the extended plasma metabolites.

Overweight/obese subjects (25≤ BMI \<33 kg/m2) aged 40 to 59 years consumed a LCD (an approximate 100 kcal/day calorie deficit) or a weight-maintenance diet (control) in a randomized, controlled design with 3-year intervention period.

Eligibility Criteria:
Inclusion Criteria:

* 25 \<= BMI \< 33 kg/m2

Exclusion Criteria:

* type 2 diabetes
* cardiovascular disease
* psychiatric problems
* any medication use
Multifactorial Falls Prevention Program - Brazil

This study is a clinical trial designed to evaluate the effectiveness of a multifactorial falls prevention program in reducing the rate of falls.

A multifactorial falls prevention program consisting of an individualized medical management of the modifiable risk factors, a progressive on-site body balance exercise plus a home-based exercise program, an educational/behavioral intervention and a fall prevention booklet will reduce the number of falls and fall rates when compared with usual care.

This study is a multicenter parallel-group randomized trial among community-dwelling men and women aged 60 years and over, who have fallen at least once in the previous year. Participants will be recruited in multiple settings in Sao Paulo - Brazil and will be randomly allocated to a control group or an intervention group.

Eligibility Criteria:
Inclusion Criteria:

* Community-dwelling older adults, men and women aged 60 and over who have fallen at least once in the last 12 months

Exclusion Criteria:

* A previous diagnosis of dementia or a cognitive decline;
* A previous stroke with a severe neurological impairment;
* A progressive neurological disease;
* A severe visual deficiency;
* Any acute illness that the physician considers as an exercise contra-indication;
* An acute vertigo or dizziness less than 3 months duration;
* Inability to keep on standing, even with the use of a walking aid or other device;
* Unable to communicate;
* Those who are engaged in a regular exercise program, including physical therapy, with a frequency of equal to or more than twice a week such as: muscle strengthening, balance or gait exercise, Tai Chi and Yoga
G-IVF and Sperm Parameters

The aim of this study is to investigate if adding a fixed volume of a physiological solution to a freshly produced sperm sample will affect sperm characteristics.


Eligibility Criteria:
Inclusion Criteria:

* Patients producing a pre-clinical semen sample at the clinic

Exclusion Criteria:

* Patients with known azoospermia
* Patients who have had a vasectomy
The Patient Enablement Instrument for Back Pain Turkish Version, Validity and Reliability Study

Most people experience low back pain at some point in their lives, and most low back pain is classified as nonspecific because the factor causing the pain cannot be identified. Current guidelines recommend self-management interventions for the management of nonspecific low back pain. The most commonly used assessment measures measure pain, disability, and quality of life. However, it is important to evaluate patients' ability to manage their nonspecific LBP-specific disease.

In 1997, Howie and colleagues introduced the concept of enablement, which represents patients' enablement, understanding of, and ability to cope with their health and illness. They developed the "The Patient Enablement Instrument" to measure patient competence based on the theory that if patients' competence increases, other important outcomes will improve. The Patient Enablement Instrument has since been translated into many languages and has generally demonstrated moderate to good validity and reliability. However, there are limitations to using the Patient Enablement Instrument as an outcome measure.

Inspired by the Patient Enablement Instrument, researchers from Denmark and Sweden developed the Patient Enablement Instrument for Back Pain , which could potentially be used as an outcome measure for interventions aimed at improving self-management in people seeking treatment for low back pain. In 2021, Nielsen et al. The validity and reliability of the scale was determined by and its use was recommended in the population experiencing low back pain. The aim of our study is to culturally adapt the Patient Enablement Instrument for Back Pain into Turkish and to examine its validity and reliability.


Eligibility Criteria:
Inclusion Criteria:

* Having low back pain for at least 3 months

Exclusion Criteria:

* Having acute pain
A Study of Monthly Subcutaneous or Intravenous Mircera in Dialysis Patients With Chronic Renal Anaemia

This open label, single arm study will assess the efficacy for long-term maintenance of haemoglobin levels and the safety and tolerability of methoxy polyethylene glycol-epoetin beta \[Mircera\] in dialysis patients with chronic renal anaemia. Patients on regular long-term haemodialysis or peritoneal dialysis will receive monthly subcutaneous or intravenous Mircera for 6 months. Target sample size is \<200 patients.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>/=18 years of age
* chronic renal anaemia
* haemoglobin 10.0-12.0g/dl at screening
* adequate iron status
* continuous stable ESA (erythropoietic stimulating agent) therapy for \>/= 2 months
* regular haemodialysis or regular peritoneal dialysis for \>/= 3 months

Exclusion Criteria:

* uncontrolled hypertension
* haemoglobinopathy
* anaemia due to haemolysis
* pure red cell aplasia (PRCA)
Comparison of Intubation With Nerve Block and With Sedation in Awake Patients

The purpose of this study is to compare intubation with nerve block with intubation with sedation in awake patients in terms of efficacy, ease, and the rate of complications and physician satisfaction


Eligibility Criteria:
Inclusion Criteria:

* Candidate for intubation with methods other than RSI
* Age\>= 18 years
* Patient or patient's guardian's consent

Exclusion Criteria:

* Need for RSI or crash intubation
* Allergy to Lidocain in block group
* Allergy to opioid drugs in sedation group
* Allergy to midazolam in either group
Ablation vs Amiodarone for Treatment of AFib in Patients With CHF and an ICD

1. To determine if catheter-based atrial fibrillation (AF) ablation is superior to Amiodarone treatment for symptomatic persistent/permanent AF in ICD/CRTD patients with an impaired left ventricular function.
2. Hypothesis: AF ablation is better than Amiodarone for subjects with symptomatic persistent or permanent AF and impaired LV function in terms of recurrence of AF, quality of life, 6-minute walk distance, EF and total number of hospitalizations.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with an dual chamber ICD or CRTD (with an existing functional atrial lead) with remote monitoring capabilities and EF \<= 40% within the last 3 months by echocardiogram, nuclear imaging, MRI or cardiac catheterization,
2. Persistent or chronic symptomatic AF resistant to anti-arrhythmic medication other than Amiodarone. Resistant defined as recurrent AF of greater than 5 minutes duration at least once per month.
3. Therapeutic anticoagulation for at least three weeks prior to initiation of therapy
4. Ability to complete 6 minute walk test.
5. Age \>= 18 years old. (Females must be either post-menopausal \>12 months, practicing a protocol-acceptable method of birth control \[defined as injectable or implantable hormonal contraceptives, oral contraceptives, intrauterine device, diaphragm plus spermicide\], or have had a hysterectomy, bilateral oophorectomy, or tubal ligation performed at least 6 months prior to enrollment).
6. All patients optimized on CHF medications including beta-blocker and ace-inhibitor or angiotensin-receptor blocker.
7. patients receiving low dose amiodarone- \<200 mg for 2 or less months

Exclusion Criteria:

The exclusion criteria are:

1. Reversible causes of AF such as pericarditis, hyperthyroidism,
2. Presently with Valvular Heart disease requiring surgical intervention
3. Presently with coronary artery disease requiring surgical intervention
4. Early Post-operative AF (within three months of surgery)
5. Previous MAZE or left atrial instrumentation
6. Prolonged QT interval
7. Hypothyroidism
8. Liver Failure
9. Life expectancy \<= 2 years
10. Social factors that would preclude follow up or make compliance difficult.
11. Contraindication to the use of anti-arrhythmic medications and/or coumadin and heparin
12. Enrollment in another investigational drug or device study.
13. Patients with severe pulmonary disease i.e. COPD or asthma
14. Documented intra-atrial thrombus, tumor, or another abnormality which precludes catheter introduction
15. Any ophthalmologic disorders (other than requiring glasses for vision correction)
Expect Respect Middle School Randomized Trial

This cluster-randomized school-based study will examine the effectiveness of a teen dating violence (TDV) and sexual violence (SV) prevention program called Expect Respect for preventing serious violence perpetration among middle school students.

This cluster-randomized controlled school-based study will examine the effectiveness of a support group-based teen dating violence (TDV) and sexual violence (SV) prevention program on the primary prevention of serious (and potentially lethal) violence perpetration among middle school students (both male and female-identified) who have prior exposure to trauma and violence. Expect Respect gender-specific support groups are for youth with prior history of exposure to violence including witnessing domestic violence, loss of loved one to homicide, TDV, and SV.

Expect Respect is a theory and research-informed program intended to alter norms condoning violence and rigid gender expectations that foster violence perpetration, promote bystander intervention, and reduce TDV/SV perpetration. Implemented by trained facilitators, the 24-session curriculum focuses on gender equity and respect, recognizing abuse and impact on self and others, regulating emotions, skills for healthy relationships, and becoming active proponents of safe and healthy relationships.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be in grades 7-8
* Participants must be referred by school personnel
* Participants must speak English

Exclusion Criteria:

* Not in 7th- 8th grade
* Not referred to the group by school personnel
* Does not speak English
The Diastolic Pressure Gradient for Patients With Acute Coronary Syndrome: Evaluation of Non Culprit Lesions

The assessment of non-culprit stenoses is an important issue in ACS. Adenosine administration is currently required for functional evaluation of stenosis severity using the fractional flow reserve (FFR). An alternative adenosine-independent index of coronary stenosis, the instantaneous wave-free ratio (iFR), was recently introduced.

Aim of the present study will be to evaluate the trans-stenotic instantaneous wave-free pressure gradient (iFG), the instantaneous wave-free ratio (iFR) and the fractional flow reserve (FFR) in ACS patients.


Eligibility Criteria:
Inclusion Criteria:

* age 40 to 80 years
* recent Acute Coronary Syndrome
* indication for coronary angiography
* presence of at least one non-culprit lesion requiring functional evaluation with fractional flow reserve (FFR):

Exclusion Criteria:

* Haemodynamically significant valvular disease
* controindication for Adenosin administration
* previous CABG on the index vessel