cyrilzakka/clinical-trials huggingface dataset:
Allogeneic Mesenchymal Stromal Cells in Elderly Patients With Hip Fracture

Prospective, unicenter, randomized, open-label, single-dose, two-arms blinded assessor pilot study. Thirty-two (32) elderly patients with hip fracture will be randomized to one of the two treatment-arms (Xcel-MT-osteo-beta or Standard treatment) and be followed for 12 month with the primary objective of safety. Secondary objectives are efficacy through axial tomography and xRay, clinical efficacy and quality of life questionnaire.

Prospective, unicenter, randomized, open-label, single-dose, two-arms blinded assessor phase I-II pilot study.

Thirty-two (32) elderly patients (70-85 years of age) with type 31A2 y 31A3 fracture of the femur (AO/ASIF (Association for the Study of Internal Fixation) classification) admitted at the emergency room of the Hospital Clinic of Barcelona will be randomized 1:1 to one of the two treatment-arms (endomedullary nailing + XCEL-MT-OSTEO-BETA or isolated endomedullary nailing as the standard treatment). Once surgically treated, patients will be followed for 12 month with the primary objective of safety. Secondary objectives are efficacy through axial tomography and xRay, clinical efficacy and quality of life questionnaire (EUROQOL-5D).

Eligibility Criteria:
Inclusion Criteria:

1. Patient between70 and 85 years old
2. Proximal femur fracture type 31A3 31a2 classification AO/ASIF.
3. Deambulation prior to fracture.
4. Written informed consent of the patient or family members.

Exclusion Criteria:

1. Presence of implants at proximal femur level.
2. Presence of local or systemic septic process.
3. Septic arthritis.
4. Dementia of any type.
5. Hematological and biochemical analysis with significant alterations that contraindicate surgery.
6. Patients with positive serology for HIV 1 and 2, Hepatitis B, Hepatitis C and syphilis.
7. Neoplastic disease detected in the last five years or without complete remission.
8. Immunosuppressive status.
9. Patients who received corticosteroids in the 3 months prior to study initiation.
10. Simultaneous participation in another clinical trial or treatment with another investigational product within 3 months prior to inclusion in the study.
11. Other conditions or circumstances that may compromise the patient's participation in the study according to medical criteria.
12. Patient refusal to be followed by a period that may exceed the clinical trial itself.
Effects of THC and CBD on Human Episodic Memory Function

THC and CBD have distinct symptomatic and behavioral effects. In healthy individuals, THC can induce psychotic symptoms and anxiety, and can impair memory. In contrast, CBD has anxiolytic and possibly antipsychotic properties, while not impairing memory and other cognitive functions. Instead, CBD has been shown to have significant neuroprotective effects. In humans, CBD values correlated positively with gray matter concentration in bilateral hippocampus. Recent data from experimental animals and in vitro studies suggest that these distinct effects might be caused by opposing effects on brain cannabinoid receptors.

Neuroimaging studies have consistently identified brain activity recorded at prefrontal and medial temporal regions as relevant for episodic memory. Additionally, the abundance of cannabinoid receptors in the hippocampus and the parahippocampal and entorhinal cortices suggests a potential impact of CBD in memory deficits typical in healthy aging. However, the evidence relating cannabinoids to these conditions is relatively recent and has been obtained from either biochemical or pharmacological studies. It might be hypothesized that CBDs could be useful to delay or even arrest the progression of functional and structural neuronal degeneration.

The investigators will use an episodic memory paradigm to test the effects of THC, CBD and placebo on memory encoding and retention and the underlying neuronal networks on healthy male subjects.


Eligibility Criteria:
Inclusion Criteria:

* no acute or chronic disease

Exclusion Criteria:

* opioid intake
* medication or drug abuse
* kidney or liver dysfunction
* claustrophobia
* none removable metallic parts (e.g. hip replacement)
Evaluating the Effectiveness of the Acute Respiratory Infection Smart Form

To evaluate the effectiveness of the Acute Respiratory Infection Smart Form

Specific Aim 1: To design and implement an integrated documentation-based clinical decision support and physician feedback system, provided in an electronic health record (EHR), to improve the management of patients with acute medical conditions.

Hypothesis 1: A documentation-based clinical decision support tool (CDSS) "smart form" physician feedback system, can be designed and implemented to facilitate documentation and physician order-entry, provide individualized, evidence-based recommendations for the management of patients acute respiratory infections (ARIs), and are usable by primary care physicians.

Specific Aim 2: To determine the effectiveness of documentation-based CDSS and physician feedback on documentation and the clinical management of patients respiratory tract infections.

Hypothesis 2A: A documentation-based CDSS "smart form" will increase the documentation of important clinical data in patients with ARI when compared to usual practice.

Hypothesis 2B: A documentation-based CDSS "smart form" will increase adherence with guidelines for the management of patients with ARI when compared to usual practice.

Eligibility Criteria:
Inclusion Criteria:

Acute Respiratory Infection visit

Exclusion Criteria:

Any patients who are not part of a panel of a participating physician
KurCoSmart Effects on People With Type 2 DM

The investigators aim to evaluate the effect of curcumin and virgin coconut oil extract supplementation on people with type 2 DM, including blood glucose, HbA1c levels, inflammation, body weight and insulin resistance evaluation

The investigators give Kurcosmart supplementation aside from diabetes standard treatment to evaluate its benefits on people with type 2 DM, considering its effect on controlling fasting and prandial blood glucose, reducing HbA1c level, controlling inflammation degree; and repairing insulin resistance

Eligibility Criteria:
Inclusion Criteria:

* Confirmed Type 2 DM
* Signing consent form

Exclusion Criteria:

* Pregnant or breastfeeding
* Multiple organ failure
* History of hypersensitivity reaction to curcumin and virgin coconut oil
* Cancer, renal insufficiency, hematological disease, acute heart failure, chronic liver disease
Focal Pain Outcomes Using Configurations Applied for Lateral Stimulation

To evaluate programming modalities at various targets for focal foot, knee pain, and groin pain relief.


Eligibility Criteria:
Key Inclusion Criteria:

* Average unilateral foot, or knee or groin pain intensity of 6 or greater on a 0-10 numerical rating scale at Baseline Visit based on 7-day average NRS score
* Subject signed a valid, EC-approved informed consent form (ICF)
* Willing and able to comply with all protocol-required procedures and assessments/evaluations
* 18 years of age or older when written informed consent is obtained

Key Exclusion Criteria:

* Significant cognitive impairment at Screening that, in the opinion of the Investigator, would reasonably be expected to impair the study candidates to participate in the study
* Participating (or intends to participate) in another drug or device clinical trial that may influence the data that will be collected for this study
Comparison of Sublingual Misoprostol and Intravenous Oxytocin in Active Management of the Third Stage of Labor

Sublingual misoprostol is superior to oxytocin in reduction of blood loss during the third and fourth stages of labor

Sublingual misoprostol is superior to oxytocin in reduction of blood loss during the third and fourth stages of labor as The data from a pharmacokinetics study suggested that the bioavaiblitiy of misoprostol after sub-lingual administration was higher than those after oral or vaginal administration

Eligibility Criteria:
Inclusion Criteria:

* Women with aheathy singleton pregnancy in spontaneous or induced labor at term .

Exclusion Criteria:

* Hypersensitivity/Contraindication to prostaglandins Antepartum hemorrhage Multiple pregnancy Cardiac disease Malpresentation Rhesus- negative mother hypersensitive disorders Severe anaemia(hemoglobin\<7g/dl)
Experience of Mutaflor Suspension Use in Preterm Infants for Immunity Improvement

EcN has been registered as a medical drug under the brand name Mutaflor® SUSPENSION in Ukraine in 2010. Indications for its clinical use are acute diarrhea in infants and toddlers including those on tube feeding tube, diarrhea in children, prophylactics of pathological colonization in newborns including premature newborns, and improvement of immunity in newborns (mature and premature).

The aim of this trial was to observe efficacy and safety of Mutaflor® SUSPENSION use for immunity improvement in preterm newborn infants

Study design: open-labeled, controlled, parallel group, non-interventional 3-weeks-study with followed prospective observation during 1 week and 1 year follow-up period.

Patients of group I take the probiotic Mutaflor orally in the dose 1 ml once a day during first week of life and three times per week during the second and third week of life. Patients of the group II don't take specific probiotic for immunity strengthening.

Eligibility Criteria:
Inclusion Criteria:

* age 12-24 hours of life;
* 1st degree of prematurity (functionally mature infant, gestational age 35-36 weeks);
* exclusive breast feeding during study;
* both parents must sign and date an informed consent for infant's participation in the study.

Exclusion Criteria:

* perinatal asphyxia ( Apgar score less than 8);
* significant concomitant disease (congenital birth defects, perinatal encephalopathy, TORCH - infections and other infectious disease of newborn, respiratory distress syndrome ets);
* clinically significant changes in blood analyze results (if needed);
* use of other probiotics or prebiotics during the first 28 days of study participation.
Perioperative Testosterone Replacement Therapy in Sarcopenic Male Colorectal Cancer Patients

With increasing age and the additional impact from the bowel cancer and the chemotherapy and/ or radiotherapy it has been described that testosterone (a male hormone produced naturally in the body) levels are reduced. Testosterone has an impact on numerous body functions including the muscle mass and quality. Previous studies have identified that muscle mass is reduced as a result of ageing but also because of the deleterious effect of cancer and chemotherapy and/or radiotherapy. There is growing evidence from published studies that patients with better muscle mass and quality, do better after surgery. Mr Jenkins and his team are therefore looking at ways, the investigators can try and prevent or reduce this muscle loss and therefore improve patient outcomes.

The aim of this study is to assess whether using testosterone replacement therapy in the form of a topically applied gel daily for a total of 12 weeks, is feasible and acceptable by the patients who are diagnosed with colorectal cancer and are waiting to undergo surgery. The investigators will also collect information related to the testosterone replacement therapy such as questionnaires on the quality of life, fatigue and muscle mass, and blood biomarker changes in the blood.


Eligibility Criteria:
Inclusion Criteria:

* Male ≥ 45 years old
* Colorectal cancer - histology confirmed
* Identified as sarcopenic on latest computerised tomography (CT) scan prior to intervention (part of initial investigations - using Martin et al (2013) criteria - 43cm2/m2 for Body Mass Index (BMI) \<25, 53cm2/m2 for BMI\>25)
* Documented low or normal testosterone at time of recruitment (\<12 nano moles/ Litre (nmol/L)
* Eligible for operative intervention
* Capacity to consent
* Able to mobilise \& able to complete the 6 Minute Walk Test (MWT)
* Post completion of chemotherapy/ chemoradiotherapy treatment (if the patient has neoadjuvant treatment)
* Booked straight for surgery with an interim of 4-8 weeks.
* Participation in another concurrent trial/ study is accepted, following discussion between the two trial /study teams

Exclusion Criteria:

* Not sarcopenic on computerised tomography (CT)
* Not eligible for surgery
* History of Deep Vein Thrombosis (DVT)/ Pulmonary Embolism (PE)/ prostate cancer/ breast cancer
* Prostate nodule identified during digital rectal examination (DRE) or magnetic resonance imaging (MRI) pelvis
* Multiple distant metastasis which are non-operable
* Prostate specific antigen (PSA) \> 3 nanogram/ mililitre (ng/ml)
* Haematocrit (HCT) \>52%
* Severe lower urinary tract symptoms
* Class III/ IV heart failure
* Myocardial Infarct or stroke within the last 6 months
* Dementia / No capacity to consent
* Patient on medications with anti-androgen effect eg spironolactone
* Patients with untreated severe obstructive sleep apnoea
* Morbid obesity as defined by Body Mass Index (BMI) \>40
* Uncontrolled hypertension
* Patients on long term steroids during the trial period
* Patient on other anabolic agents
* Not already on treatment for primary hypogonadism
* Patients with bone metastasis
COVID-19 Tests: Nasopharyngeal Swab vs Saliva Collected With Salivette® Cortisol for Viral RNA Sampling for RT-qPCR

The main objective of the tests is to establish saliva collection with Salivette® Cortisol.


Eligibility Criteria:
Inclusion Criteria:

1. Informed consent form signed and dated before any samples have been taken.
2. Suspected or confirmed SARS-CoV-2 infection by PCR within the past five days.
3. Male and/or female patients aged 18 years and over.
French Database of Left Atrial Appendage Closure

Patients with atrial fibrillation are exposed to a high risk of thrombus in the left atrium that can induce cerebral vascular events or systemic embolisms. This justifies the prescription of anticoagulant therapies in patients with high risk of thromboembolic event. Percutaneous left atrial appendage closure is a new interventional strategy for patients with high risk of cardiovascular events and a counter-indication for long term treatment with anticoagulant agents. However, only few data are available on effectiveness and prognosis of patients treated by this new interventional strategy.

This national database record per-procedure and follow-up data of patients treated by left atrial appendage closure.

This database is strictly observational.

Percutaneous left atrial appendage closure is performed only for the purpose of patient care. No specific intervention is performed specifically for the database. Neither left atrial appendage closure procedure nor patient follow up are modified by patient inclusion in the database.


Eligibility Criteria:
Inclusion Criteria:

* Patients referred to a french interventional cardiology department for percutaneous left atrial appendage closure in routine care
* Signature of an inform consent form for inclusion of data recorded during care in the database

Exclusion Criteria:

none
Goal-directed Fluid Therapy in Elderly Patients Undergoing Lumbar Surgery

This is a randomized controlled clinical trial which investigates whether goal directed fluid therapy( GDT ) would show the evidence of benefit from GDT in terms of lactate kinetics then may reduce postoperative complications in patients undergoing spine surgery, especially in prone positions.

This is a single-center, randomized controlled clinical trial. Patients aged \> 60 undergoing lumbar decompression surgery will be randomly assigned to either a GDT ( goal directed fluid therapy) group or a control group, who received conventional anesthesiologist-directed fluid therapy. Perioperative lactic acid concentrations with 7 different time point, intraoperative fluid balance and postoperative complications from admittance to 30 days after surgery were recorded. This RCT is conducted to show the evidence of benefit from GDT in terms of lactate kinetics then may reduce postoperative complications in patients undergoing spine surgery, especially in prone positions.

Eligibility Criteria:
Inclusion Criteria:

* age \> 60 years, American Society of Anesthesiologists score II-III, and expected duration of operation \> 2 h

Exclusion Criteria:

* Patients with severe cardiac arrhythmia (which would affect the accuracy of stroke volume variation as an indicator of fluid responsiveness), vascular disease (which would prohibit radial artery cannulation), and mental disorder were excluded
Development of Novel Designed Force Plate for Measuring the Balance Ability for the Elders

To develop a force plate with a proper computing algorithm that can be used in the average household as well as within community care centers. An affordable price range will also be necessary.

Many studies using force plates to examine the elders' balance ability for fall prevention. However, few studies compare the reliability differences among age in postural sway measurements even though many studies find significantly greater postural sway in the elder population than compared to the younger cohort. Investigation of this age difference is important for choosing variables to represent their postural sway improvement in order to determine the intervention outcome.

Eligibility Criteria:
Inclusion Criteria:

* Young adults between 20 and 25 yrs
* Seniors between 67 to 75 yrs.

Exclusion Criteria:

* Lower limb neuromuscular diseases
* Musculoskeletal injuries
* Any negative response
A Phase 2 Study of Intravenous or Subcutaneous Dosing of Sotatercept (ACE-011) in Patients With End-Stage Kidney Disease on Hemodialysis

To determine the optimal route of administration, dose level, and safety of intravenous and subcutaneous dosing of sotatercept for maintaining hemoglobin levels in subjects who are on hemodialysis.


Eligibility Criteria:
Inclusion Criteria:

1. Males or females ≥ 18 years of age.
2. Subjects on at least 6 hours of hemodialysis per week, for at least 12 weeks before screening
3. Subjects must be on a stable intravenous or subcutaneous dose of Erythropoietin Stimulating Agents (excluding methoxy polyethylene glycol-epoetin beta \[Mircera\]) to maintain hemoglobin.
4. A mean predialysis hemoglobin concentration ≥ 10 g/dL (grams per deciliter) to ≤ 12 g/dL (≥ 100 g/L (grams per liter) to ≤ 120 g/L) obtained from three consecutive days.

4. A Body Mass Index value ≥ 18.5 kg/m2 (kilograms per m2) at screening. 5. Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted.

6. Able to adhere to the study visit schedule and comply with all protocol requirements.

Exclusion Criteria:

1. Non renal causes of anemia
2. Subjects on peritoneal dialysis.
3. Systemic hematological disease
4. Uncontrolled diabetes mellitus (HbA1c (hemoglobin A1c) \> 9%) at screening.
5. Uncontrolled hypertension defined as mean of home systolic blood pressure \> 160 mm Hg (millimeter of mercury) or mean of home diastolic blood pressure \> 90 mm Hg calculated once during the screening period prior to randomization
6. Subjects with heart failure
7. History of malignancy (except excised and cured non-melanoma skin cancer, or cervical carcinoma in situ that was surgically ablated more than 5 years ago).
8. Anticipated or scheduled living donor renal transplant during the course of the study.
Atazanavir and Lamivudine for Treatment Simplification

Objectives of the study:

1. To verify the safety of the study treatment, defined as the persistent control of the virus' replication at 48 weeks after the simplification to lamivudine + atazanavir with ritonavir.
2. To collect relevant information about the safety and the metabolic impact of this strategy in order to eventually design a non-inferiority randomized controlled trial for the evaluation of the safety and the efficacy of this strategy in the future.

Combined antiretroviral therapy has greatly improved the natural history of HIV infection/AIDS. Yet, it is associated with important short- and long- term side effects. In particular, nucleoside and nucleotide analogs may cause anemia, pancreatitis, mitochondrial dysfunction, lactic acidosis, lipoatrophy and reduction of renal function or of bone density.

Our study aims to verify the safety and efficacy of a simplification of a dual therapy (Lamivudine plus Atazanavir with Ritonavir), confiding on the potency and high genetic barrier of ritonavir-boosted agents.

Eligibility Criteria:
Inclusion Criteria:

* Patients treated with the same regimen including 2NRTIs + ATV/r from at least 6 months
* Aged 18 years or older
* Who gave informed consent to the participation to the study
* With at least two viral load \< 50 copies/mL in two consecutive determinations at least 3 months apart
* With CD4 cell count \> 200 cells/μL and absence of any opportunistic infection or AIDS-related disease by one year at least

Exclusion Criteria:

* Pregnancy or breast feeding, desire of pregnancy in the short term
* Previous virological failure to antiretroviral therapy and/or previous exposure to mono- or dual therapies with reverse transcriptase nucleosidic analogues
* Patients with insufficient atazanavir plasma through concentration (lower than 0.23 μg/mL at 12th hour or 0.15 μg/mL at 24th hour) at screening and/or at baseline
* Patients with grade 3 or 4 laboratory abnormalities at screening (except for glucose or lipid serum levels and direct or indirect bilirubin)
* Concomitant treatment with antacids or proton-pump blockers or any other drug with known interactions or contraindications with the study medications
Efficacy and Safety of Two Doses of Liarozole vs. Placebo for the Treatment of Lamellar Ichthyosis

Lamellar ichthyosis is a congenital disease of the skin with a generalized scaling. The primary activity of liarozole is considered to be the inhibition of the degradation of a substance called retinoic acid, which is the principal endogenous regulator of growth and differentiation of epithelial tissues in mammals. The current study intends to evaluate the efficacy and safety in patients with lamellar ichthyosis.

Lamellar ichthyosis is an autosomal recessive disorder that is apparent at birth and is present throughout life. Although the disorder is not life threatening, it is quite disfiguring and causes considerable psychological stress to affected patients. Prevalence is less than 1 case per 300,000 individuals. Treatment is mainly symptomatic i.e. emollients with or without keratolytic agents. Treatment with systemic retinoids is reserved for those patients, refractory to conventional therapy, because of the long-term adverse effects and teratogenicity of systemic retinoids.

Liarozole may provide a new concept for the treatment of this condition. Because of its mechanism of action, retinoic acid (RA) levels will only be increased in tissues that are targets for RA production.

The proposed Phase II/III study intends to evaluate the efficacy of liarozole compared with placebo, in patients with lamellar ichthyosis.

Eligibility Criteria:
Inclusion Criteria:

* Subjects of either sex aged 14 years or older.
* Clinical diagnosis of lamellar ichthyosis
* Women of childbearing potential should use appropriate contraception
* Women of childbearing potential should have a negative pregnancy test at screening visit.
* Subjects are, except for their lamellar ichthyosis, in good general health.
* Subjects and legal representative(s), if applicable, signed informed consent.

Exclusion Criteria:

* Subject is receiving topical (except emollient), UV treatment or systemic treatment for ichthyosis.
* Subject is pregnant or breast feeding.
* History or suspicion of alcohol or drug abuse.
* Significant co-existing diseases.
* Clinically significant abnormal ECG
* History of hypersensitivity to retinoids or any of the ingredients in the trial medication.
* Clinically relevant laboratory abnormalities at screening.
* Use of immune-suppressive drugs including topical or systemic corticosteroids.
* Participation in an investigational trial 30 days prior to the start of the trial.