cyrilzakka/clinical-trials huggingface dataset:
Integrated Client Care Project Trial: Wound Care Evaluation

This study will use a randomized control trial design to compare wound care clients who receive "integrated care" versus "usual care" in Community Care Access Centres (CCAC) in Ontario. Data will be collected by existing administrative databases and linked by the Institute for Clinical Evaluative Sciences (ICES). The researchers will analyze these databases and report findings.

The researchers are interested in finding out whether the intervention ("integrated care") helps to improve patient outcomes. A randomized control trial of wound care clients in Ontario CCACs will show the effects of the intervention (integrated care) versus "usual care" clients. The researchers will also examine the financial system costs associated with providing "integrated care" to clients versus "usual care".

The researchers expect to answer the research question of whether there is difference in patient outcomes between "integrated care" versus "usual care clients." The researchers also would like to formulate a response for whether there will be financial system cost difference between "integrated care" and "usual care" clients.

The goal of this evaluation is to help decision-makers in the Ministry of Health and Long Term Care (MOHLTC), in the Community Care Access Centres (CCACs) and among provider organizations to improve the quality of care and patient outcomes for wound care clients, by evaluating innovations in the delivery of care.

Eligibility Criteria:
Inclusion Criteria:

* receives wound care from Community Care Access Centre provider
* adults over age 18 in Ontario

Exclusion Criteria:

* patients who do not receive wound care from Ontario Community Care Access Centres
First In Human Study on Synthetic Surfactant CHF 5633 in Respiratory Distress Syndrome

The aim of this study is to investigate the safety and tolerability of intratracheal administration of two different single doses of CHF 5633 in preterm neonates with RDS in terms of adverse events, adverse drug reactions, hematology and biochemistry values, the incidence of major neonatal morbidities including bronchopulmonary dysplasia (BPD) and mortality.

The study will be a multicentre, open-label, single escalating dose, per-cohort design.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent obtained by parents/legal representative (according to local regulation) prior to any study-related procedures
* Inborn and outborn, preterm neonates of either sex with a gestational age of 27 weeks up to 33 weeks+6
* Clinical and radiological findings typical of RDS
* Age on admission to the study \< 24 hours from birth
* Requirement of endotracheal intubation for surfactant administration
* Fraction of inspired oxygen (FiO2) \> 0.35 to maintain SpO2 between 90-95 %
* Documentation of normal cranial ultrasound scan

Exclusion Criteria:

* Use of surfactant prior to study entry and need for intratracheal administration of any other treatment (e.g. nitric oxide)
* Known genetic or chromosomal disorders, major congenital anomalies (cardiac malformations, myelomeningocele etc)
* Maternal drug abuse (heroin, methadone, methamphetamine, or cocaine) or significant alcohol consumption during pregnancy
* Clinical chorioamnionitis (Appendix III)
* Strong suspicion of congenital pneumonia/infection, sepsis
* Evidence of severe birth asphyxia or a 5 minutes Apgar score less / equal 3
* Presence of air leaks prior to study entry
* Neonatal seizures prior to study entry
* Mothers with prolonged rupture of the membranes (\> 3 weeks duration)
* Any condition that, in the opinion of the Investigator, would place the neonate at undue risk
* Participation in another clinical trial of any placebo, drug or biological substance conducted under the provisions of a protocol
Influence of Pantoprazole on the Pharmacokinetics of Fradafiban After Multiple Oral Doses of Lefradafiban in Healthy Subjects

Study to assess the absorption of 20 mg Lefradafiban in two formulations, each under physiological conditions and with 40 mg Pantoprazole


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects as determined by results of screening
* Signed written informed consent in accordance with good clinical practice (GCP) and local legislation
* Age ≥ 18 and ≤ 60 years, planned stratification: age \< 40 years (4 subjects) and ≥ 40 years (8 subjects)
* Broca ≥ - 20 % and ≤ + 20 %

Exclusion Criteria:

* Use of any drugs which might influence the results of the trial within 10 days prior to administration or during the trial
* Intake of drugs with a long half-life (\> 24 hours) within 1 month prior to administration
* Participation in another trial with an investigational drug within 2 months prior to administration or during the trial
* Drug abuse
* Alcohol abuse (\> 60 g/day)
* Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days
* Excessive physical activities within 5 days prior to administration or during the trial
* Blood donation within 1 month prior to administration or during the trial
* History or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, hormonal disorders
* Chronic or relevant acute infections
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
* History of

  * Allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
  * Any bleeding disorder including prolonged or habitual bleeding
  * Other hematologic disease
  * Cerebral bleeding (e.g. after a car accident)
* Recent surgical procedures
* Thrombocytes \< 150000/µ
* Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
* Any laboratory value outside the clinically accepted reference range
* Other disease or abnormality of clinical relevance
The Effects of L-Tyrosine on 24 Hour Blood Pressure and Heart Rate in Parkinson's Disease

The investigators are observing the effects 2,000 mg of L-tyrosine will have on 24 hour blood pressure fluctuations in individuals with Parkinson's disease.

We will be monitoring 24 hour ambulatory BP and HR in subjects with PD on 3 separate visits. The first visit will be without an intervention to establish a baseline of 24 hour BP fluctuations. One week later the subject will be given either L-tyrosine (2,000 mg) with B6 (10 mg) or a sugar pill. We will monitor 24 hour BP and HR after supplementation. One week later the subject will repeat the same procedures with either supplement or placebo.

This is a total of 3 visits with 24 hour ambulatory BP and HR monitoring.

Eligibility Criteria:
Inclusion Criteria:

1. All subjects must have a diagnosis of PD by a licensed neurologist according to the UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria (UKPDBB).(Goetz, 2010) The UKPDBB is a 3 step diagnostic tool which defines inclusion and exclusion criteria for diagnosing PD
2. between 35 and 79 years of age
3. mentally able to participate in the study

Exclusion Criteria:

1. Pregnancy
2. any person who is currently taking amino acid supplements.
3. Any history of myocardial infarction, stent, or CABG
4. Phenylketonurics
5. Untreated hypertension
A Single Center, Prospective, Case Series of the Treatment of Pressure Ulcers and Decubitus Ulcers.

The purpose of this study is to investigate the efficacy and safety of dehydrated amnion/chorion membrane (dHACM) in the treatment of patients with stage II or III pressure ulcer and decubitus ulcers


Eligibility Criteria:
Inclusion Criteria:

1. Index ulcer characteristics:

   1. Index ulcer area after debridement is ≥ 2 cm² and ≤ 25 cm² at the randomization visit
   2. Ulcer must be Stage II or III as determined by the National Pressure Ulcer Advisory Panel (NPUAP) pressure ulcer staging system
2. Subject criteria must include:

   1. Age 18 or older
   2. The subject or their legally authorized representative provides consent and is willing and able to participate in all procedures and follow-up evaluations necessary to complete the study

Exclusion Criteria:

1. Index ulcer characteristics that will make subject ineligible for enrollment:

   1. Stage I or IV ulcers as determined by NPUAP pressure ulcer staging system
   2. Signs and symptoms of local infection
   3. Previous surgical procedure performed at site
   4. Known or suspected local skin malignancy at index ulcer site
   5. Prior radiation therapy treatment at the index ulcer site
2. Subject criteria that will make subject ineligible for enrollment:

   1. Presence of other diseases which, in the Opinion of the Investigator, may result in allograft failure or has experienced graft failure in the past (examples include: immune system disorders including Systemic Lupus Erythematosus (SLE), Fibromyalgia, Acquired Immunodeficiency Syndrome (AIDS) or HIV)
   2. Currently taking medications which in the opinion of the investigator may affect graft incorporation
   3. Allergy or known sensitivity to Aminoglycosides such as gentamicin sulfate and/or streptomycin sulfate
   4. Any condition(s) that in the opinion of the investigator may seriously compromises the subject's ability to participate in this study. Examples include: known history of poor adherence with medical treatment, current drug or alcohol abuse or a medical/psychiatric condition
   5. Pregnancy at enrollment or within last 6 months, women who are breastfeeding, or women of childbearing potential who are planning to become pregnant during the time of the study OR are unwilling/unable to use acceptable methods of contraception (birth control pills, barriers, or abstinence)
   6. Subjects currently enrolled in this study (i.e. concurrent enrollment in the study is prohibited)
   7. Subject has used any investigational drug(s) or therapeutic device(s) within 30 days preceding screening.
   8. Any pathology that would limit the blood supply and compromise healing
   9. Subject is a prisoner
The Comparison of Remimazolam With Propofol in Core Body Temperature

1. Core body temperature is normally tightly regulated to within a few tenths of a degree. The major thermoregulatory defences in humans are sweating, arteriovenous shunt vasoconstriction, and shivering.
2. Inadvertent hypothermia often complicates prolonged surgery. In patients becoming sufficiently hypothermic, reemergence of thermoregulatory vasoconstriction usually prevents further core hypothermia.
3. The extent to which anesthetics reduce the vasoconstriction threshold depends on the type of drug and its concentration.

1. When propofol induces anesthesia, blood pressure decreases due to vasodilation, which is due to direct action on vascular smooth muscle and vasodilation due to blockage of the sympathetic nervous system. This results in a redistribution of body temperature, resulting in hypothermia.
2. The effects of remimazolam on the central nervous system, respiratory and cardiovascular system have been studied. Remimazolam, a new type of benzodiazepine drug acts on the GABA-A receptor and has the advantages of rapid induction, rapid recovery, stable hemodynamics, and mild respiratory inhibition. At present, there is little literature on its practice in intraoperative thermoregulation under general anesthesia.
3. Investigators hypothesized that the type of anesthetic agents might affect thermoregulatory mechanisms such as the redistribution of body heat, cutaneous heat loss or inhibition of thermoregulatory vasoconstriction. Therefore, Investigators investigated to compare remimazolam with propofol in core body temperature, vasoconstriction threshold and times to onset of vasoconstriction(min)in patients given laparoscopic assisted vaginal hysterectormy.

Eligibility Criteria:
Inclusion Criteria:

1. ASA physical classification I-III,
2. Patients who undergoing Robotic-assisted or laparoscopic (LRP) radical prostatectomy.

Exclusion Criteria:

1. Patients who have Medications or any implanted device that could affect cardiovascular function
2. Patients who have a history with heat imbalance, thyroid diseases, dystautonomia, Raynaud's syndrome, uncontrolled diabetes mellitus, or hypertension.
Home Treatment for Acute Psychiatric Care

This study aims to evaluate whether psychiatric home treatment is an effective and efficient alternative to acute inpatient care in mental hospitals. A one-year prevalence cohort of psychiatric patients in need of hospitalization are randomly assigned to either treatment at inpatient wards (treatment as usual) or a new care model with the additional option of treating patients at their homes by mobile care teams. The primary focus is on checking whether optional home treatment leads to a reduction of inpatient days during a two-year follow-up period. In addition, the two service models will be compared regarding treatment cost and outcomes as well as satisfaction of patients and their relatives with psychiatric care.

Furthermore, a sub-cohort of randomly chosen patients from the prevalence-cohort will be examined by a highly trained clinical assessor to test and verify the diagnoses and the clinical ratings made by the staff members of the mental hospital under routine everyday conditions.

This study aims to evaluate whether psychiatric home treatment is an effective and efficient alternative to acute inpatient care in mental hospitals. A one-year prevalence cohort of psychiatric patients in need of hospitalization are randomly assigned to either treatment at inpatient wards (treatment as usual) or a new care model with the additional option of treating patients at their homes by mobile care teams. The primary focus is on checking whether optional home treatment for crisis intervention leads to a reduction of inpatient days during a two-year follow-up period. In addition, the two service models will be compared regarding treatment cost and outcomes as well as satisfaction of patients and their relatives with psychiatric care.

Furthermore, a sub-cohort of randomly chosen patients from the prevalence-cohort will be examined by a highly trained clinical assessor to test and verify the diagnoses (SCID-I and SCID-II) and the clinical ratings (HoNOS) made by the staff members of the mental hospital under routine everyday conditions.

Eligibility Criteria:
Inclusion Criteria:

* Need for acute psychiatric inpatient care
* Residence in the canton of Aargau
* Living within 30 minutes (by car) from the headquarters of the home treatment team
* Health insurance with tarifsuisse

Exclusion Criteria:

* Insufficient proficiency in German
* Main diagnosis F0 or F1 (ICD-10)
* Patients of the forencic departement
* Patients of the child and adolescent department
Cancer Communication Within Hispanic Social Networks

This trial examines cancer communication within Hispanic social networks. Hispanics have the lowest colorectal cancer screening rate of any major ethnic group and health interventions are crucially needed among Hispanics. Patient decision aids are health communication interventions designed to provide patients with targeted health information and have shown to improve colorectal cancer screening rates among Hispanics. The goal of this study is to investigate, in a sample of Hispanics, how a colorectal cancer decision aid aimed at increasing individuals' colorectal cancer screening behavior has effects on their alters' intention to get screened for colorectal cancer.

OUTLINE:

Participants view an educational video on cancer and cancer screening options over 12 minutes. Participants also complete a phone survey over 10-15 minutes before attending the video session and 2 months after the video session.

Eligibility Criteria:
Inclusion Criteria:

* Self-identify as "Hispanic" or "Latino"
* Have no family history of CRC
* Have no personal history of pre-cancerous (adenomatous) colonic polyps
* Have not had either an annual fecal occult blood test (FOBT) within the past year or colonoscopy within the last 10 years (defined as up-to-date with CRC screening by current United States \[U.S.\] Preventive Services Task Force recommendations)
* Have at least two family members, friends, or co-workers who are ages 50-75
* Alters will be eligible if they are ages 50-75
Bladder Distension for Pain Relief in Nullliparous Patients Undergoing Diagnostic Office Hysteroscopy

This study is conducted to assess whether the passive uterine straightening of the uterus by means of bladder filling is associated with less pain experienced by nulliparous women during office hysteroscopy.

A randomized controlled study revealed that bladder filling before office hysteroscopy was associated with less pain experienced by parous women . On the other hand, a randomized study revealed that misoprostol was more effective than bladder filling in minimizing the pain experienced by postmenopausal women during office hysteroscopy. Till now , no studies were conducted to detect the effect of bladder filling on the pain experienced by nulliparous women during office hysteroscopy.

Eligibility Criteria:
Inclusion Criteria:

* Nulliparity

Exclusion Criteria:

* Parous patients
* Cervical pathology
* Previous cervical surgery
* Severe vaginal bleeding.
Effect of Pectin in Chronic Kidney Disease Patients ( Stage 3 and 4 )

Effect of pectin in chronic kidney disease patients

Chronic kidney disease (CKD) is a serious global health problem leading to serious comorbidities, end-stage renal disease (ESRD), and death

From 1990 to 2016, the prevalence of CKD increased by 90% worldwide, which is closely tied to the increase in at-risk populations with diabetes mellitus (DM), hypertension (HTN), and prediabetes . It is estimated to be around 9.1 to 13.4%. This means there are about 700 million to over 800 million cases of CKD worldwide.

In 2017, CKD resulted in 1.2 million deaths and was the 12th leading cause of death worldwide . And in the same year, the estimated prevalence of CKD in Egypt was 7.1 million individuals, which means 106 patients/1000 population .

Pectin, a class of heteropolysaccharides based on polygalacturonic acid, is a safe and non-toxic natural food additive recommended by the Joint FAO/WHO Committee on Food Additives with no daily additive limit . Pectin is mainly obtained from apple pomace, citrus peels and sugar beets, ancurrently, commercial pectin contains ≥65% Gal-A (galacturonic acid).

Among the patients who tried to take the pectin, unexpectedly was found that the pectin had a significant effect on the rapid reduction of blood creatinine concentration in patients with chronic kidney disease. So, the authors followed up the physical examination indeces of chronic kidney disease patients who took the Pectin .

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of CKD patients (stage 3 and 4)
2. age between 18 and 60 years
3. Must be able to swallow tablets

Exclusion Criteria:

1- End stage renal disease ( stage 5 ) 2 - Patients with renal transplantation 3- pregnancy 4- Presence of malignancy
Corneal Endothelium Delivery Instrument

The purpose of this study is to determine whether the surgical outcomes in patients undergoing Descemet's Stripping Endothelial Keratoplasty (DSEK) are improved with the use of an insertion device over the traditional forceps insertion method.

Laboratory studies and clinical functionality tests have shown that the study device safely forms the tissue without creasing or folding. It allows the allograft tissue to safely pass into the anterior chamber without compression, crushing, or squeezing the endothelial cells.

The device provides continuous irrigation into the eye to prevent collapse of the anterior chamber during insertion. Our study will focus on the safety and efficacy of the novel instrument over the current method of insertion (forceps).

FDA has classified the device as Class I, Reserved.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Fuchs endothelial dystrophy or bullous keratopathy determined to need a corneal transplant for visual restoration.
Prospective Evaluation of an RDT to Screen for Gambiense HAT and Diagnose P. Falciparum Malaria

A prototype rapid diagnostic test (RDT) to simultaneously screen for gambiense human African trypanosomiasis (HAT) and diagnose P. falciparum malaria (the "HAT/malaria combo") has recently been developed. The performance of this prototype has been evaluated in a retrospective study that showed that its diagnostic performance for HAT and malaria was equivalent to the performance of the SD BIOLINE HAT 2.0 and the SD BIOLINE Malaria Ag P.f tests, respectively.

The purpose of this study is to prospectively evaluate the performance of the test in settings where P. falciparum malaria is endemic, and which are either endemic or non-endemic for HAT. This will enable the assessment of the suitability of the HAT/malaria combo RDT as a diagnostic test for malaria, and a screening test for HAT in pre-elimination and post-elimination contexts, respectively.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 6 years
* Provision of signed informed consent. For children (under the age of 18) provision of signed informed consent by a parent or legal guardian and an age appropriate assent.

Exclusion Criteria:

* Severe anaemia preventing collection of a sample of venous blood
* Severe medical condition preventing informed consent and trial participation (e.g. coma, cognitive impairment, etc.)
* For HAT true negatives only: history of previous HAT infection