cyrilzakka/clinical-trials huggingface dataset:
Curcumin in Patients With Mild to Moderate Alzheimer's Disease

The purpose of this study is to examine the safety and tolerability of curcumin, and to determine its effect on patients with mild to moderate Alzheimer's Disease (AD).

Curcumin, a yellow substance found in the spice Turmeric, has antioxidant, non-steroidal anti-inflammatory (NSAID), and cholesterol-lowering properties, all of which make it a good candidate in the prevention and treatment of AD. The study will examine the safety and tolerability of 2 different doses of curcumin C3 complex. Blood and cerebrospinal fluid (CSF) tests will be used to examine how the curcumin is absorbed in the body, and whether it has an effect on inflammation, oxidative damage, and cholesterol levels. Participants will also be tested to determine the potential effect of curcumin on cognition, behavior, and daily function in patients with mild to moderate AD.

Participants will be randomly assigned to receive one of two doses of curcumin, or a placebo, for the initial 6 months of the trial. For the final 6 months, those receiving a placebo will be switched to one of the two doses of the drug. The 33 participants will make 7 visits to the study site over a 12-month period. These visits may include a physical and neurological examination, routine laboratory tests, lumbar puncture, and neuropsychological (mood and memory) evaluations.

Eligibility Criteria:
Inclusion Criteria:

* Male or female at least 50 years old
* Diagnosis of probable AD
* No history of significant psychiatric or non-AD neurological disease
* Proficient in English to be able to perform cognitive testing
* Caregiver available to monitor and administer medication and to accompany patient to every clinical visit
* On stable doses of cholinesterase inhibitors and memantine (Alzheimer's medications) for 3 months prior to enrollment
* On stable doses of all other allowed medications for at least one month prior to starting the study medication

Exclusion Criteria:

* Current or recent major psychiatric illness (i.e. bipolar disorder, schizophrenia)
* Significant, uncontrolled systemic illness (i.e. chronic renal failure, chronic liver disease, poorly controlled diabetes, or poorly controlled congestive heart failure)
* Recent history of gastrointestinal bleeding or ulceration
* Alcoholism or substance abuse within the past year
* Familial, autosomal dominant Alzheimer's disease due to a mutation in a known gene (Presenilin-1, Presenilin-2, or Amyloid Precursor Protein)
* NSAIDs (e.g. ibuprofen, naproxen, etc.) taken on a regular basis (more than 3 times per week)
* Aspirin at doses more than 325 mg per day
* Coumadin, heparin, other anticoagulants
* Antioxidants or other supplements including gingko biloba, coenzyme Q10, alpha-lipoic acid
* Vitamin E at doses more than 2,000 IU per day
* Vitamin C at doses more than 500 mg per day
Efficacy Of Zinc Towards The Outcome on Children With Sepsis

Sepsis is a life-threatening organ failure induced by a compromised immune response to infection. Sepsis is a leading cause of morbidity and mortality (50-60%) in children treated in inpatient and critical care units. Children suffering from immunodeficiency have a higher mortality rate. Several studies in recent years have revealed that zinc homeostasis may be a significant role in the prevention of sepsis. It was important to conduct this study to determine the efficacy of zinc in children suffering from sepsis.

This research is a randomized controlled trial with parallel study design conducted in Makassar, South of Sulawesi, Indonesia from February to May 2024. This study was conducted on children with a diagnosis of sepsis. Patients were divided into two groups, namely zinc group which received standard therapy with zinc and placebo group which received standard therapy with placebo.

The inclusion criteria were children aged 1 month to 18 years, diagnosed with sepsis, and parents/caregivers willing to participate their children in this study. Patients with diarrhea, malnutrition, Acute Kidney Injury due to kidney illness, hematological diseases, patients who have received zinc in the previous month, and patients who leave on their own request are all excluded from this study. Patients who not taking medication for up to three days in a row, either due to forgetfulness or self-determination, or due to side effects, and being unable to complete the study before the end date for various reasons, including death were declared dropouts.

Researchers will provide informed consent to parents/caregivers of children who met the research criteria. Anamnesis, general physical examination, and clinical also laboratory parameters were examined on day 0, 8, and 11 after zinc and placebo supplementation, such as; degree of consciousness, use of mechanical ventilators, P/F ratio, MAP, lactate levels, serum leukocyte and platelet counts, CRP and procalcitonin levels, lactate levels, sepsis progression, and mortality rates. The research results are recorded in a research form and the data is grouped and SPSS version 21.0 software is used for data analysis. A p value \<0.05 was considered for statistical analysis. This study was approved by the ethics and research committee of the faculty of medicine, at Hasanuddin University.

Eligibility Criteria:
Inclusion Criteria:

- Children aged 1 month to 18 years with diagnosis of sepsis

Exclusion Criteria:

* Diarrhea
* Malnutrition
* Acute Kidney Injury due to kidney illness
* Hematological diseases
* Have received zinc in the previous month
* Leave on their own request

Dropping out criteria:

* Not taking medication for up to three days in a row
* Death
Effects of Different Assisted Mechanical Ventilation in Acute Lung Injury/Acute Respiratory Distress Syndrome (ALI/ARDS) Patients: Pressure Support Ventilation (PSV), Neurally Adjusted Ventilatory Assist (NAVA) and Controlled by Patient

The investigators' aim is to study the effect of pressure support ventilation versus neurally adjusted assist (NAVA) and controlled by patient in mechanically ventilated ALI/ARDS subjects.

In this study, PSV is compared with NAVA and assisted mechanically ventilation controlled by patient through a button. Inclusion criteria are: assisted mechanically ventilated ALI/ARDS patients.

Eligibility Criteria:
Inclusion Criteria:

* ALI/ARDS patients

Exclusion Criteria:

* Haemodynamic instability
* Barotrauma
* COPD
An Extension Long-Term Study of RoActemra/Actemra (Tocilizumab) in Patients With Polyarticular Juvenile Idiopathic Arthritis Who Completed The WA19977 Study

This long-term, open-label extension study will evaluate the safety of RoActemra/Actemra (tocilizumab) in patients with polyarticular-course juvenile idiopathic arthritis who completed the WA19977 core study. Patients aged 9-18 years with at least JIA ACR30 clinical response to RoActemra/Actemra in the core study will be eligible to receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks. Anticipated time on study treatment is 104 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Patients 9 to 18 years of age who completed visit 33 (week 104) of WA19977 study with at least JIA ACR30 clinical response to RoActemra/Actemra relative to baseline in WA19977, with no AEs, SAEs or conditions that lead to unacceptable risk of continued treatment
* Females of child-bearing potential and males with female partners of child-bearing potential must agree to use effective contraception as defined by protocol

Exclusion Criteria:

* Patients with, according to investigator judgment, not satisfactory benefit from RoActemra/Actemra therapy within WA19977
* Treatment with any investigational agent since the last administration of study drug in the core study WA19977 or current participation in another clinical trial except WA19977
* Patient developed any other autoimmune rheumatic disease or overlap syndrome other than the permitted polyarticular-course JIA subsets: rheumatoid factor positive or negative JIA or extended oligoarticular JIA
* Patient is pregnant , lactating, or intending to become pregnant during the study and up to 12 weeks after the last administration of study drug
* Any significant concomitant disease or medical or surgical condition
* History of significant allergic or infusion reactions to prior biologic therapy
* Currently active primary or secondary immunodeficiency
* Current abuse of alcohol, drugs or chemical abuse
* Known and currently active acute, subacute, chronic infections or history of recurrent infection; patients suffering from ongoing active infections with Epstein Barr virus, herpes zoster or recurrent history of urinary tract infection can be included after the (acute) infection has been excluded or subsided
* Positive for latent tuberculosis (TB)
* Currently active asthma for which the patient has required the use of oral or parenteral corticosteroids for \>/= 2 weeks within 6 months prior to entering the study
* Inadequate hepatic, renal or bone marrow function
Apligraf Versus Standard Therapy in the Treatment of Diabetic Foot Ulcers

The purpose of this study is to determine the ability of Apligraf to improve the time to and incidence of complete wound closure of diabetic foot ulcers, as compared to diabetic foot ulcers treated with standard therapy.

Ulceration of the diabetic foot is a result of multiple problems including repetitive stress on a neuropathic or insensate area that is often associated with an underlying bony prominence. By healing diabetic foot ulcers quickly the risks of infection, osteomyelitis (infeciton of the bone) and limb loss can be reduced.

This study will evaluate the ability of Apligraf to heal diabetic foot ulcers that have been present for at least 2 weeks and are between 1 - 16 cm2 in area. Patients will be randomized to either (50:50 chance) treatment with Apligraf or a saline moistened dressing regimen (standard therapy). All patients will receive standard cares for the ulcers which includes debridement, orthotics and off-loading throughout the treatment period.

Eligibility Criteria:
Inclusion Criteria:

* diabetic ulcer of primarily neuropathic origin on the plantar region of the forefoot
* ulcer extending through the dermis but without sinus tract, tendon, capsule or bone exposure
* ulcer present for at least 2 weeks and measuring 1- 16 cm2
* diminished sensesation on target extremity/foot
* ulcer is not infected
* Type 1 or 2 diabetes with adequate glycemic control
* Adequate vascular supply to the target extremity

Exclusion Criteria:

* Charcot foot
* Non-neuropathic ulcers
* Skin cancer within or adjacent to the target ulcer
* Osteomyelitis or an infected ulcer
* Clinically significant medical condition that would impair wound healing
* Females who are pregnant
* Received within 4 weeks of study entry systemic corticosteriods, immunosuppresive agents, radiation therapy or chemotherapy
Observational Hemodynamic Monitoring During LVAD Implantation Among Individuals With Advanced Heart Failure

The overall objective of this pilot analysis is to characterize the hemodynamic changes that occur during implantation of a left ventricular assist device (LVAD) in patients with advanced heart failure - specifically, how right ventricular function is compromised as a result of LVAD implantation.


Eligibility Criteria:
Inclusion Criteria:

* individuals ≥ 18 years of age with severe heart failure (HF) and who have been approved by the advanced HF selection committee for LVAD implantation.

Exclusion Criteria:

* Patients with pre-existing right ventricular (RV) dysfunction/failure, defined as:

  1. Imaging evidence of moderate-severe RV dysfunction on echocardiography
  2. Hemodynamic evidence of RV dysfunction with:

     * a right-atrial pressure (RAP): pulmonary capillary wedge pressure (PCWP) ratio of ≥ 0.67 (note: this index compares pressures on the right \[RAP\] and left \[PCWP\] side of the heart;
     * an RAP/PCWP ratio ≥ 0.67 provides hemodynamic evidence of RV dysfunction.
  3. Clinical evidence of preexisting RV dysfunction, as indicated by significant (3-4+ peripheral edema) and/or elevated jugular venous pressures on clinical examination.
  4. Patients with end-stage renal disease requiring hemodialysis
  5. Patients requiring temporary hemodynamic support prior to LVAD implantation with temporary LVADs, and/or veno-arterial extracorporeal membrane oxygenators ("ECMO").
  6. Planned concurrent implantation of right ventricular assist device
Wound Closure (Allgower) Versus Secondary Open Wound Healing After Removal of the External Fixator

In this prospective randomized controlled single-center trial, based on a non-inferiority design, the outcome of the treatment of patients are analyzed, whereas in half of the cases the wounds are left open and the other ones are primary wound closed after local debridement after Fixator-Extern is removed. Although this topic embodies a daily business, there is no standard to be found in literature regarding the treatment of pin sites with closure by either primary or secondary intent.

In the orthopedic department of the Kantonsspital Lucerne (LUKS) after removal of the external fixator, the pin sites at the tibia and the back of the foot are routinely treated with primary wound closure. An international survey carried out by the LUKS shows that in comparison to our standard treatment the majority of surgeons left the pin sites open during the healing process. In order to find a standardized method to treat pin sites we conduct a randomized controlled trial, in which half of the pin site wounds are left open and the other half are treated by primary wound closure after local debridement (Treatment of the first pin-side will be randomized, then alternated treatment of the consecutive pin-sides). All patients of the study participants are treated within a fixed pre- and postoperative protocol, which includes antibiotic prophylaxis with a single shot of Cefazolin 2g intravenously 30 minutes prior to surgery. The postoperative pin care includes daily inspection of the pin sites, cleaning the secondary healing wound with Ringerfundin © and disinfection with Betadine ©. Primary wound closures are dressed with dry gaze bandage. The following out-patient treatment is provided either by a Spitex support, the family doctor or by the patient himself, depending on the patients compliance. Regular follow-up consultations at 2, 6, 12, 24 and 52 weeks after surgery ensure an adequate surveillance of the healing process, whereas the examining doctor at the second and last consultation was kept in dark what therapy was chosen for pin sites of the patient. To objectify the clinical progress the pin sites are photo documented at the consultations at week 2 and 52.

Eligibility Criteria:
Inclusion Criteria:

* Completed 18th year of age
* Supply by external fixator
* Signed informed consent for study participation

Exclusion Criteria:

* Patients with immunodeficiency (HIV / hepatitis infection, leukemia, steroid therapy, autoimmune therapy)
* Patients who can not perform a follow-up treatment for structural reasons (tourists, not home canton) or other reasons
* Lack of knowledge of German
* Lack of consent to study participation
* invalid patients
PLD-cyclophosphamide-Nab-P Continuously Combined With Dual HER2 Blockage for HER2-positive Breast Cancer

patients with HER2-positive breast cancer (cT2-3/N0-1/M0) were treated with PldCHP (pegylated liposomal doxorubicin 35mg/m2, cyclophosphamide 600mg/m2, trastuzumab 8 mg/kg loading, then 6 mg/kg, pertuzumab 840 mg loading, then 420 mg, iv, q3w) for 4 cycles followed by Nab-PHP (Nab-Paclitaxel 260mg/m2, trastuzumab 6 mg/kg, pertuzumab 420 mg, iv, q3w) for 4 cycles

Upon approval by the Medical Ethics Committee of Xijing Hospital, patients with HER2-positive breast cancer (cT2-3/N0-1/M0) receiving neoadjuvant therapy, were enrolled. The patients were treated with PldCHP (pegylated liposomal doxorubicin 35mg/m2, cyclophosphamide 600mg/m2, trastuzumab 8 mg/kg loading, then 6 mg/kg, pertuzumab 840 mg loading, then 420 mg, iv, q3w) for 4 cycles followed by Nab-PHP (Nab-Paclitaxel 260mg/m2, trastuzumab 6 mg/kg, pertuzumab 420 mg, iv, q3w) for 4 cycles, with strict monitoring of cardiotoxicity. The primary endpoint was pCR rate, and secondary endpoints were cardiac safety during neoadjuvant therapy.

Eligibility Criteria:
Inclusion Criteria:

1. HER2-positive breast cancer
2. cT2-3/N0-1/M0
3. aged18-80 years
4. receiving neoadjuvant therapy
5. ECOGPS score 0 or 1
6. Able to understand the test requirements, willing and able to comply with the test and follow-up procedures
7. Adequate organ function

Exclusion Criteria:

1. cardiac, hepatic, renal, or psychiatric disease history
2. History of other malignancy within the last 5 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
Efficacy Testing of Different Tourniquet Pressure Used for Postoperative Pain Reduction in Total Knee Arthroplasty

Tourniquet use during total knee replacement (TKR) improves visibility, significantly decreases intra-operative blood loss and reduce operative time. However, tourniquet use also has a negative effect on postoperative pain, postoperative range of motion(ROM), wound complication, deep vein thrombosis (DVT), pulmonary embolism (PE), thigh muscle strength, and functional recovery after TKR. Therefore, the investigators conducted a three-arm prospective, randomized, controlled trial study to compare the efficacy of different tourniquet pressure used between systolic blood pressure + 75 mmHg, systolic blood pressure + 100 mmHg, and systolic blood pressure + 150 mmHg.

Patients scheduled for unilateral primary TKA; 150 patients were randomly assigned to receive tourniquet pressure used of systolic blood pressure + 75 mmHg, systolic blood pressure + 100 mmHg, and systolic blood pressure + 150 mmHg.

All patients had spinal anesthesia, the same operative procedure, and postoperative pain protocol. A visual analogue scale (VAS) for pain were recorded 24, 48 hours, and 2 weeks postoperatively. Quality of bloodless visual field and calculated blood loss were evaluated perioperatively. Postoperative ROM, wound complication, deep vein thrombosis (DVT), pulmonary embolism (PE) were recorded at 2, 6, and 12 weeks. Furthermore, Knee Society Score (KSS) also recorded at 6 weeks, 3 and 6 months. The reviewers were blinded to the treatment group.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with osteoarthritis in need of a TKR

Exclusion Criteria:

* Inflammatory arthritis
* Post-traumatic arthritis
* Body mass index \> 30 Kg/m2
* A history of or current venous thromboembolic disease
* Any underlying disease of hemostasis, cirrhosis, chronic renal failure, patients on anticoagulants or strong antiplatelet drugs (e.g. warfarin, clopidogrel)
* Preoperative hemoglobin \<10 g/dL or a platelet count \< 140,000 /uL3
* Allergy to transamine
Analgesic and Respiratory Outcomes in Patients Receiving Continuous Bilateral Erector Spinae Plane Block Compared to Continuous Preperitoneal Catheter Wound Infusion After Upper Abdominal Surgery

We aim to compare the postoperative analgesic and respiratory outcomes in patients receiving continuous bupivacaine infusion via bilateral erector spinae catheters versus preperitoneal catheters in upper abdominal surgeries.


Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I-II, weighing 50-90 Kg with Body Mass Index (BMI) 18.5- 29.9 kg/m2

Exclusion Criteria:

* ASA physical status ≥III, pregnancy, body mass index \>30 kg/m2, preoperative opioid consumption, patient's refusal and contraindications of the use of spirometry or either of the truncal blocks under the study including; respiratory, cardiac, neurological, mental or coagulation disorders.
Safety and Biological Activity of InfraDure Biopump Secreting Sustained Interferon in HCV Patients

This will be a Phase I-II, open-label, single center, uncontrolled, dose-escalation study. The trial will be conducted in Israel at the Tel Aviv Sourasky Medical Center.

All subjects will receive autologous InfraDure Biopump (micro-organ of dermis processed ex vivo transduced with genetic construct containing the gene for interferon)tissue implants intended to provide sustained production and delivery of therapeutic levels of INF for up to twenty four (24) weeks following INFRADURE Biopump implantation. Follow up will continue for a total of two years post INFRADURE Biopump implantation

Medgenics Inc. and Medgenics Medical Israel Ltd. are developing INFRADURE, an autologous dermal biopump capable of sustained secretion of therapeutic INF in the body, using a small tissue explant from the patient's own skin. The INFRADURE biopump is produced from a micro-organ (MO), typically measuring 30 mm in length and 1.5-2.5 mm diameter, which is harvested directly from the patient's dermis under local anesthesia. The micro-organ can be viably maintained ex-vivo for extended periods of time under standard culture conditions. INFRADURE Biopumps, produced by ex vivo transduction of MOs with Helper Dependent Adenoviral INF vectors (HDAd-INF), express and secrete INF. INFRADURE Biopump is monitored ex vivo prior to re-implantation, to attain true INF dosing. The INFRADURE Biopump is subsequently implanted subcutaneously back to the patient in order to provide continuous delivery of a known amount of INF. Each implanted autologous INFRADURE Biopump remains localized under the skin, and is accessible, so that if necessary, it can be removed or ablated at any time. The entire process from harvest to implantation requires 10-14 days

Eligibility Criteria:
Inclusion Criteria:

* Signed patient consent form
* Genotype 3 chronic HCV with detectable HCV RNA
* No previous treatment for HCV infection
* Hepatitis B and human immunodeficiency virus negative at screening visit
* Able and willing to follow contraception requirements
* Screening laboratory values, test, and physical exam within acceptable ranges

Exclusion Criteria:

* Current enrollment in another investigational device or drug study
* Anticipated inability to complete all clinic visits and comply with study procedures
* History of, or any current medical condition, which could impact the safety of the subject during the study
* Autoimmune hepatitis, suspected hepatocellular carcinoma, decompensated liver disease, or other known liver disease other than HCV
* Alcoholism or substance abuse with \<6 documented months of sobriety
* Known allergy or sensitivity to interferons or ribavirin
* Any other condition that, in the opinion of the Investigator, would make the subject unsuitable for enrollment or could interfere with the subject participating in and completing the study