cyrilzakka/clinical-trials huggingface dataset:
Discharge Education of Integrated Traditional and Western Medicine Reduces Re-hospitalization in Patients With Chronic Heart Failure

Although interventions combining patient education and postdischarge management have demonstrated benefits in patients with chronic heart failure, the benefit attributable to patient education alone is not known. The investigators hypothesized that a patient discharge education program would improve clinical outcomes in patients with chronic heart failure.

Although interventions combining patient education and postdischarge management have demonstrated benefits in patients with chronic heart failure, the benefit attributable to patient education of Integrated Traditional and Western Medicine is not known. The investigators hypothesized that a patient discharge education of Integrated Traditional and Western Medicine program would improve clinical outcomes in patients with chronic heart failure.

Eligibility Criteria:
Inclusion Criteria:

* Candidates for this study were admitted to the hospital with a diagnosis of heart failure and documented left ventricular systolic dysfunction (ejection fraction\<0.40).

Exclusion Criteria:

* CKD4 and CKD5
Burst Spinal Cord Stimulation (Burst-SCS) Study

Recently a new form of spinal cord stimulation therapy called burst spinal cord stimulation (Burst-SCS) is available to treat chronic pain. The goal of this study is to learn more about how Burst-SCS works to reduce chronic pain. The study will examine chronic pain patients who have been deemed candidates for Burst-SCS therapy, and who have already been selected to receive a temporary externalized trial of Burst-SCS from their own doctors as part of their standard clinical care for chronic pain management. During the study, participants will be asked to complete a variety of evaluations at certain time points. In addition, there will be a randomized, double blind, crossover phase, where the particular effects of Burst-SCS and sham SCS will be evaluated. The device used to deliver Burst-SCS and sham SCS is the St. Jude Medical Invisible Trial System.


Eligibility Criteria:
Inclusion Criteria:

* Men or women with chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with any of the following: failed back surgery syndrome and intractable low back and leg pain, and for whom Burst-SCS has been recommended as a treatment option
* Candidates who can speak, read, and understand English

Exclusion Criteria:

* Subjects who are pregnant- as determined by verbal report or chart review
* Subjects with current, habitual, or previous use within the last 12 months of artificial nails, nail enhancements, or nail extensions that cover any portion of either thumbnail. Exceptions, including brief and/or occasional use, may be permissible at the discretion of the principal investigator
* Subjects who are unable or unwilling to cooperate with clinical testing
* Subjects having any impairment, activity or situation that, in the judgement of the study coordinator or PI, would prevent satisfactory completion of the study protocol
Polyurethane Foam-Pink Pad (RCT) Use in OR

King Abdullah medical city has a cardiac center, and a lot of open-heart surgeries are performed there, and both polyurethane foam (pink Pad) and Mepilex dressing are applied to those patients. Therefore, the present study was designed to compare the effects of polyurethane foam (pink Pad) versus Mepilex dressing for prevention of pressure ulcer in operating room.

There are two types of intervention available in King Abdullah medical city for operating room pressure ulcer prevention. Polyurethane foams (Pink Pad) are a single use system for use in surgical procedures. The system consists of a proprietary formulation for the pink foam pad, non-woven lift sheet, body straps, head rests, and boot liners. It aids hospital facilities in providing a safe and effective method of management of the patient for pressure ulcers and non-movement for patients in the Trendelenburg position.

Mepilex Border Sacrum dressings are self-adherent, multilayer foam dressings designed for use on sacrum aiming to prevent pressure ulcers. The dressings are used in addition to standard care protocols for pressure ulcer prevention.

All included patients received standard PU prevention according to hospital protocols, based on contextualization and adaptation of International guidelines ( European Pressure Ulcer Advisory Panel, 2021 ), which involved: assessment of PU risk through the Braden Scale at hospital admission,

Eligibility Criteria:
Inclusion Criteria:

* Subjects ≥ 18.
* Willing to participate.
* Patients undergoing cardiac surgery.
* Patient who is at risk for PU development as measured with Braden scale.
* Patient who has skin intact and having a life expectancy greater than 72 hours as per clinical judgement.

Exclusion Criteria:

* Subjects under 17
* Not consenting to participate
* Patients with suspected hypersensitivity reactions to any of the dressing formulation's ingredients.
* Patients who are unable to continue the study because of death or change in the care setting.
Use of Letrozole for Ectopic Pregnancy

A randomized clinical trial using oral letrozole 10mg/day for 7 days, for treating early cases of ectopic pregnancy, compared to intramuscular methotrexate

This is a multicenter randomized clinical trial on the use of letrozole in the medical treatment of tubal ectopic pregnancy. Tubal ectopic pregnancy is an abnormal pregnancy in the fallopian tube. They occurred in about 8% of all pregnancies presenting to the emergency department. Methotrexate (MTX), administered systemically (intramuscularly), is a widely used medication for the treatment of unruptured tubal ectopic pregnancies and has been recommended as first-line treatment for early cases of ectopic pregnancy.

Letrozole is an aromatase inhibitor and can suppress estradiol levels. Some recent studies have shown that its use can be applied in cases of ectopic pregnancy.

The aim of this non-inferiority clinical trial is to verify that letrozole treatment is non-inferior to methotrexate treatment in women with early ectopic pregnancy who are hemodynamically stable.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Diagnosis of ectopic pregnancy
* Desire for reproduction
* Ease of return
* Undetermined pregnancy location with abnormal hCG growth
* Presence of a heterogeneous adnexal mass on pelvic ultrasound suggestive of a tubal ectopic pregnancy with an hCG level ≤ 3000 mIU/ml
* Absence of fetal cardiac activity
* Average diameter of the adnexal mass ≤ 3.5 cm
* Hemodynamically stable
* No significant abdominal pain (i.e, \< 6 on a visual analog scale)

Exclusion Criteria:

* Presence of a significant amount of free fluid in the pelvis (as assessed by the ultrasound technician)
* Allergy to methotrexate or letrozole
* A reduction in β-hCG ≥ 50% in 2 measurements with 48 hours between them or

  ≥ 85% in 4 days, or ≥ 95% in 7 days before randomization
* Abnormal liver function test (Alanine transaminase (ALT) ≥ 2 times the upper limit of normal)
* Abnormal renal function test (glomerular filtration rate ≤ 45 ml/min)
* Hemoglobin \<10 g/dl
* Platelets \<120.000/ml
* Presence of heterotopic pregnancy
* Do not wish to participate in the study.
Functional Residual Capacity (FRC) Guided Alveolar Recruitment Strategy

In ventilated patients open endotracheal suctioning may lead to alveolar derecruitment, which can be monitored by means of functional residual capacity (FRC) measurements. The investigators hypothesized that a recruitment strategy based on FRC measurements would improve oxygenation and regional ventilation after an open endotracheal suctioning manoeuvre.

In mechanically ventilated patients the functional residual capacity will be measured before (baseline) and after an open endotracheal suctioning manoeuvre. Based on these changes patients will be divided into two groups: Group A with more than 94% of baseline FRC, and Group B with less than 94% of baseline FRC. Both groups will be randomized to receive an alveolar recruitment manoeuvre or no alveolar recruitment manoeuvre, leading to four groups. Oxygenation and regional ventilation with electrical impedance tomography will be studied.

Eligibility Criteria:
Inclusion Criteria:

* ventilated after elective cardiac surgery

Exclusion Criteria:

* hemodynamic instability (eg. intraaortic balloon pump)
* acute lung injury, i.e. PEEP \> 10cmH20 or FiO2 \> 0.4
Can Pregabalin Reduce the Frequency and Severity of Dry Eye Symptoms After Laser-assisted in Situ Keratomileusis?

Can Lyrica (Pregabalin) help prevent severe Dry Eye post LASIK surgery?

Dry eye symptoms can occur after LASIK surgery. They generally get better with time but in some patients, they can persist. The investigators believe that in some individuals, dry eye symptoms after LASIK persist because the nerves in the cornea become hypersensitive. The investigators wish to study if a medication, called pregabalin, can protect corneal nerves at the time of LASIK surgery and decrease the frequency and severity of dry eye symptoms 6 months after surgery. This medication has been used in a similar way to reduce the frequency of uncomfortable sensations after other surgeries (knee, abdomen) but has never been studied in LASIK surgery.

Eligibility Criteria:
Inclusion Criteria:

* 18 and 65 years of age
* undergoing LASIK (unilateral or bilateral procedure).
* Females of child-bearing age will need a negative urine or serum pregnancy test at the screening visit.
* ocular and systemic medication regimen has been stable for 3 months

Exclusion Criteria:

* Pregnant or lactating, participating in another study with an investigational drug within one month prior to screening
* Using gabapentin, pregabalin, anti-convulsants, duloxetine, venlafaxine (SNRI), or tri-cyclic antidepressants
* have a history of allergic, anaphylactic reaction, or severe systemic response to pregabalin or gabapentin
* use corticosteroids chronically or during the month prior to surgery, or have a history of corneal disease (HSV or varicella zoster keratitis, prior corneal incisions (cataract surgery, radial keratotomy, LASIK), prior corneal ulcer).
* patients with systemic co-morbidities that may confound DE such as HIV, sarcoidosis, graft-versus host disease or a collagen vascular disease.
* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Prisoners
Treatment of Intimate Partner Violence and Substance Abuse in a Forensic Setting

Intimate partner violence is a significant societal problem. However, treatment of IPV perpetrators is far from effective, which may be partly due to the fact that the role of substance abuse is not taken into account. There is considerable evidence that a strong relationship between the use of alcohol and other drugs and intimate partner violence exists. Besides, a few studies indicate that reducing substance use may have a positive impact on IPV. Therefore, in this study, perpetrators of intimate partner violence with substance use disorders enrolled in domestic violence treatment will be randomly assigned to either standard treatment for offenders of domestic violence or a combination of the latter treatment with cognitive-behavioral therapy addressing substance abuse (combined treatment).


Eligibility Criteria:
Inclusion Criteria:

* A history of perpetration of intimate partner violence
* Current alcohol, cannabis and/or cocaine abuse or dependence
* Still in an intimate relationship with the victim

Exclusion Criteria:

* Not sufficient fluency in Dutch to complete treatment and measures
* (ab)use of crack cocaine and/or heroin
* In need of clinical detoxification
* Severe mental disorders, such as psychosis
* Severe cognitive disorders, such as Korsakoff's syndrome
* In treatment for other mental health problems
* Abuse of children
Effects of Caffeine on Cerebral Blood Flow

The goal of this clinical trial is to evaluate in clinically healthy young people if:

* after caffeine ingestion, there are variations in blood velocity of the middle cerebral arteries (VMCA),
* this variation is dependent on the administered dose.

Transcranial Doppler ultrasonography was used to record blood VMCA in three groups of 15 clinically healthy young adults each - no caffeine, low caffeine (45 mg) and high caffeine group (120 mg). Transcranial Doppler ultrasonography provided simultaneous bilateral VMCA measurements while subjects performed functional tests (hyperventilation and hypoventilation orders) and three cognitive activities (Test 1, short-term remembering, Test 2, solving a vocabulary problem, and Test 3, solving a math problem) each in 31-second tests with 1-minute rest between them. Participants were assessed before and 30 minutes after caffeine ingestion.

Were used in the study, Capsules dosed with 45mg and 120 mg of anhydrous caffeine and flour capsules as a placebo. In the preparation of the capsules, a semi-automatic capsulator No. 0 (Capsunorm® by Tecnyfarma®) were used, colorless hard gelatin capsules No. 0 by Acopharma® and anhydrous caffeine (Biochem®, C.A.S. 58-08-2).

Viasys Sonara transcranial Doppler unit and a 2 MHz probe were used to sample the middle cerebral artery at depths of 60 millimeters, using emission doppler pulsed performing spectral analysis in real time. Two probes (bilaterally) of 2MHz were placed at a depth between 55 and 60 mm, thus making it possible to analyse both middle cerebral arteries simultaneously.

Each participant was asked not to ingest caffeine and exercise vigorously for at least 12 hours before the assessment. In the case of smokers, they were also asked not to smoke for at least 2 hours before the evaluation. The laboratory had medium luminosity, silent and controlled temperature (23º/24ºC). To avoid inter-observer errors, all examinations were performed by the same investigator who was not aware of what dose was/had been administered to the participant.

Subjects were tested while seated in a reclining chair located in a dimly lit, sound-attenuated room and performed the activities with their eyes closed.

Eligibility Criteria:
Inclusion Criteria:

* clinically healthy young people

Exclusion Criteria:

* Individuals with hypertension, high cholesterol, diabetes, arrhythmias, carotid sinus syndrome, severe carotid stenosis and who were in an unstable clinical situation.
Efficacy of Bone-marrow-derived and Placenta-derived Multipotent Mesenchymal Stem / Stromal Cells for Osteoarthritis

To define the clinical effects of intra-articular transplantation of bone-marrow-derived (BM-MMSCs) and placenta-derived multipotent mesenchymal stem / stromal cells (P-MMSCs) for knee osteoarthritis.

Multipotent mesenchymal stem / stromal cells (MMSCs) of different origin are the novel therapeutic agents that can slow down cartilage degeneration, improve reparation and ultimately prevent joint prosthetics. MSCs are capable to direct differentiation into chondrocytes, produce cytokines and growth factors with immunomodulatory and anti-inflammatory effects, stimulate angiogenesis, as well as induce chemotaxis of endogenous progenitors. Bone marrow-derived and placenta-derived MMSCs can be considered the most promising source for cell therapy of joints disorders according to availability, safety and expected therapeutic efficacy.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of knee osteoarthritis.
2. Age: 18 to 75 years old.
3. Kellgren-Lawrence Grade 2 or 3 according to X-ray imaging.
4. Knee pain.
5. Written informed consent

Exclusion Criteria:

1. Age \<18 or \>75 years of age by time of infusion.
2. Participation in an on-going investigational therapeutic or device trial 30 days of consent.
3. Rheumatoid arthritis.
4. Psoriatic arthritis.
5. Juvenile idiopathic arthritis.
6. Gout.
7. Infectious arthritis.
8. Osteomyelitis.
9. Osteonecrosis.
10. Inflammatory arthritis.
11. Chondropathy.
12. Joint contracture.
13. Arthroplasty.
14. Arthroscopy within 6 months prior to study entry.
15. Intra-articular injection within 3 months prior to study entry.
16. Hormone intake.
17. Antiaggregants and anticoagulants intake.
18. Immunosuppressants intake.
19. Allergy to hyaluronic acid.
20. History of organ or cell transplantation.
21. Hematologic abnormality evidenced by hematocrit \< 25%, white blood cell \< 2,500/ul or platelet count \< 100,000/ul.
22. Active infection.
23. Positive for HIV antigen.
24. History of hepatitis B, hepatitis C.
25. History of malignancy in the last 5 years prior to study entry.
26. Active tumors.
27. History of myocardial infarction.
28. History of stroke.
29. Renal failure with chronic hemodialysis.
30. Liver Cirrhosis (ICGR 15 \>30%).
31. Chromosomal abnormality.
32. Peripheral nervous system disorders.
33. Cognitive or language barriers that prohibit obtaining informed consent or any study elements.
34. History of drug abuse or alcohol abuse, or documented medical, occupational, or legal problems arising from the use of alcohol or drugs within the past 24 months.
35. Pregnant/nursing women or women of child-bearing potential.
36. Other condition that limits lifespan to \< 1 year.
A Study of KW-3357 in Congenital Antithrombin Deficiency

The aim of this study is to determine the pharmacokinetics, safety and tolerability of KW-3357 in asymptomatic subjects with congenital antithrombin deficiency.

Patients with Congenital Antithrombin Deficiency are at increased risk of venous thrombosis and pulmonary embolism especially when undergoing certain high risk procedures. Antithrombin replacement therapy is often administered during these periods, with or without low molecular weight heparin. Prior to assessing the efficacy of KW-3357, a new recombinant human antithrombin, the present study will determine it's pharmacokinetics, safety and tolerability in subjects who have Congenital Antithrombin Deficiency but who are currently asymptomatic and not undergoing a high-risk procedure. Up to 16 evaluable subjects will be enrolled at multiple investigational sites over a period of approximately 7 months.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects at least 18 years of age with congenital Antithrombin deficiency (AT activity ≤60% of normal) in a stable condition without evidence of acute thromboembolic events
* Signed IEC-approved Informed Consent Form
* Subjects must not have received an infusion of Antithrombin for at least 14 days before Screening
* Patients of reproductive potential must agree to follow accepted birth control methods during the study

Exclusion Criteria:

* Subjects who are classified as morbidly obese (defined by the presence of a body mass index \>40 kg/m2)
* Subjects who have participated in a study with an investigational drug within 30 days of Screening or within 5.5 times the elimination half-life of the investigational drug before Screening, whichever period is greater
* Subjects with any clinically relevant medical history or current condition or physical findings, ECG, or laboratory values which could interfere with the objectives of the study or the safety of the subject
* Subjects using non-steroidal anti-inflammatories, fondaparinux sodium, dabigatran or rivaroxaban or who are expected to be treated with these drugs during the study
* Subjects who have concomitant nephrotic syndrome
* Female subjects who are pregnant or lactating
* Subjects who are taking heparin, low molecular weight heparin and/or oral anticoagulants, with the exception of vitamin K antagonists (eg, warfarin)
Dose Escalation Study of IL-7 and Bi-therapy in HCV Patients Resistant After 12 Weeks of Bi-therapy (ECLIPSE 1)

This study will evaluate the safety of a new experimental drug, IL-7, in people with HCV infection resistant after 12 weeks of bi-therapy.

This is a Phase I inter-patient dose-escalation study assessing weekly doses of Interleukin-7 (CYT107) in adult patients infected by Genotype 1 Virus of Hepatitis C and resistant to standard treatment with Peg-Interferon and Ribavirin (biotherapy)after 12 weeks of this standard bi-therapy.

The dose escalation is aimed at establishing the safety of a biologically active doses of CYT107 added to the combination therapy of pegylated interferon-alpha and ribavirin. At each dose level, study patients will receive a subcutaneous administration of CYT107 per week for a total of 4 administrations.

Groups of 3 to 6 patients will be entered at each dose level of CYT107. Four dose levels are planned.

Eligible patients will a cycle of four weekly injections at a defined dose level in addition to the bi-therapy. Standard bi-therapy will continue 4 weeks after CYT107 treatment discontinuation. The duration of study is approximately 11 weeks including screening period.

Participants have 1 hospitalization overnight and 8 clinic visits. The four administrations are sub-cutaneous and are given as a shot under the skin in the arm or abdomen or leg.

During the study visits the following may be done:

* Medical history, physical examination, blood tests every visit.
* Electrocardiogram (EKG)
* Chest x-ray study
* Liver/spleen imaging
* Blood sample collections at frequent intervals
* Urine tests several times during the study.

Eligibility Criteria:
Main Inclusion Criteria:

* Genotype I infected patients
* Age \> 18 years
* Absence of early viral response to a first treatment with PEG-interferon-alpha plus ribavirin given for at least 12 weeks. Absence of early viral response (EVR) will be defined as detectable HCV with a decrease HCV RNA load \< 2 logs, measured by a quantitative PCR tests, as compared to baseline levels measured by a similar technique
* Ongoing treatment by PEG-interferon-alpha plus ribavirin at study entry

Main Exclusion Criteria:

* Infection by HBV
* Infection by HIV-1 and /or HIV-2
* Apart from HCV infection, presence of active infection requiring a specific treatment or a hospitalization
* Cirrhosis (Metavir F4) assessed by biopsy or FibroScan® or by liver biopsy within the last 6 months prior CYT107 treatment initiation. If assessed by Fibroscan® patients with a result \> 10 KPa will be excluded
* Other liver disease (notably from alcoholic, metabolic or immunological origin)
* Body mass index (BMI) \> 30kg/m2
* Inability to give informed consent
* Administration of growth factors (G-CSF, EPO) within the 12 weeks of the combination therapy
Skin Sparing Mastectomy and Immediate Breast Reconstruction With Latissimus Dorsi Flap After Neoadjuvant Chemotherapy and Radiotherapy (M-RIC)

The aim of the study is to evaluate the feasibility and morbidity of skin sparing mastectomy and immediate breast reconstruction with latissimus dorsi flap after neoadjuvant chemotherapy and radiotherapy in invasive breast carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Women \< 75 year old
* Invasive breast carcinoma, indication for mastectomy
* Women Health Organization (WHO) score of 0 and 1, primary chemotherapy, external radiotherapy performed less than 8 week earlier...

Exclusion Criteria:

* Women older than 75
* Metastatic breast carcinoma
* Antecedents of previously treated homolateral breast carcinoma
* Documented cancer progression
* Smoker at the moment of the indication surgery
* Known diabetes, neoadjuvant hormonal treatment...