cyrilzakka/clinical-trials huggingface dataset:
Probiotics and GBS Colonization in Pregnancy

Multicentric, randomized, placebo-controlled, double-blind, parallel group study aimed at evaluating the feasibility and effect of the use of probiotic starting from the 30th week, on vaginal / rectal colonization of GBS in women at low obstetric risk.

Multicenter, randomized, placebo-controlled, double-blind, parallel group study aimed at evaluating the feasibility and effect of the use of probiotic starting from the 30th week, on vaginal / rectal colonization of GBS in women at low obstetric risk.

The study includes low obstetric risk pregnant women within the 33rd week of gestation, with vaginal delivery expected. It excludes women who during pregnancy had a positive urine culture for GBS, women with a previous newborn suffering from early sepsis, use of antibiotics in the month prior to enrollment, women unable to understand the study and sign informed consent.

Intervention Daily oral administration of two capsules of the Giellepi Spa class IIa medical device "Respecta" or placebo, to be taken with a glass of water preferably between meals, starting from the 30th week of pregnancy until the 37th week after having vagino-rectal swab screening performed.

Eligibility Criteria:
Inclusion Criteria:

* low obstetric risk pregnant women by the 33rd week of gestation,
* vaginal delivery expected.

Exclusion Criteria:

* positive urine culture for GBS,
* previous newborn suffering from early sepsis,
* use of antibiotics in the month prior to enrollment,
* women unable to understand the study and sign informed consent.
SENSING-AI in Patients with Long COVID (SENSING-AI)

The retrospective study will be used to develop an artificial intelligence model of risk stratification of physiological and psychological complications arising from the information available in the electronic medical record and first consultation report to support patients and healthcare professionals in better managing the healthcare process for patients diagnosed with long COVID.

The stratification of the risk of complications related to persistent COVID both physiological and psychological in a personalized way would optimize the cost-effectiveness model for the management of these patients. Similarly, the early detection of complications associated with persistent COVID in patients belonging to vulnerable groups would improve care times and, therefore, the patient's prognosis.

The primary objective for this study is to gather anonymized retrospective data of patients suffering from long COVID in order to contribute to the generation of the SENSING-AI cohort.

Eligibility Criteria:
Inclusion Criteria:

* Legal adult
* Diagnosed of long COVID-19 in the last year
* With the presence of any of these symptoms:
* Asthenia (Tiredness)
* Dyspnea
* Shortness of breath
* Anxiety
* Stress
* Depression
* Sleep disorder

Exclusion Criteria:

* Attended to specialized care consultation
* Was admitted in hospital in the last year due to a problem not related to the COVID complications
Intraoperative Simultaneous Pressure Guided Revascularization Study

This study aims to determine whether intraoperative physiologic measurements of blood flow to the leg during endovascular treatment of Peripheral Arterial Disease (PAD) can predict future clinical outcomes.

Lower extremity peripheral arterial disease (PAD) caused by atherosclerosis can cause cause leg pain, gangrene, and limb loss. PAD is a result of poor blood flow to the extremity, and the emerging most common initial method of interventional treatment is endovascular therapy, for example angioplasty or stenting. The poor blood flow to the extremity can be inferred by the hemodynamic pressure of blood in the leg. These toe or ankle pressure measurements are typically performed before surgery to diagnose PAD, and after surgery as surveillance.

However, endovascular treatment has a high failure rate often exceeding 20% within a year. There is evidence that physiologic measurements prior to treatment and after treatment are closely related to clinical outcomes. This study introduces these physiologic measurements to the operating room, to determine if physiologic improvement can be detected instantaneously during endovascular revascularization. Patients will be followed for a year following surgery to detect hemodynamic and clinical outcomes. The rationale of these intraoperative measurements would be to potentially guide future surgery, by providing real-time hemodynamic feedback to the operator.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective or semi-urgent endovascular procedures on lesions of the aorta, iliac, femoral, popliteal, or tibial arteries
* Symptomatic, atherosclerotic Peripheral Vascular Disease. These symptoms include any Rutherford's classification.

Exclusion Criteria:

* Concurrent hybrid open procedure during endovascular revascularization requiring vascular clamping for any period of time, such as endarterectomy
* Prior open vascular surgery performed on the affected leg
* Emergent intervention for Acute Limb Ischemia, defined as symptoms lasting less than 14 days
* Non-femoral vascular access
A Dietary Supplement for Mood Symptoms in Early Postpartum: A Double Blind Randomized Placebo Controlled Trial

The purpose of this study is to determine whether a dietary supplement (DS) is effective in protecting against sad mood in postpartum as compared to placebo.

This double blind placebo controlled randomized trial will evaluate the effect of administration of a dietary supplement (DS) on the intensity of postpartum blues. It is expected that the administration will result in less sadness in day-5 postpartum women after negative mood induction in those receiving the dietary supplement compared to placebo.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 45
* BMI 19 to 40 (kg/m2)
* Resting pulse between 45 and 100 bpm
* Systolic blood pressure between 91 and 139 mmHg (inclusive)
* Diastolic blood pressure between 51 and 90 mmHg (inclusive)
* Orthostatic blood pressure change \<20 mmHg (based on the difference between supine and standing (1 minute) systolic blood pressure)

Exclusion Criteria:

* The subject has been diagnosed with any axis 1 and 2 disorders based on Structured Clinical Interview (SCID) for the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5) interview within the past 10 years.
* Subjects who have been smoking cigarettes in the past 5 years (to reduce variability in mood attributable to cigarette withdrawal and monoamine oxidase A (MAO-A)).
* Intolerance to any of the components of the intervention.
* If in the principal investigator's judgement the obstetric or neonatal complications were so severe that would cause change in the results of the study, such as infant death, the subject will be excluded.
Examining the Experiences of Brain Injury Patients in Medical Trials

Historically, participation in clinical trials has been skewed towards certain groups. However, research on the factors that influence participation, both positive and negative, is limited.

Brain injury clinical trial patients help us identify these factors by sharing trial experiences during the course of the interventional medical study.

This study will include a diverse group of participants to gather a wide range of information on clinical trial experiences. The collected data will then be used to benefit future brain injury patients who are considering participating in a medical study.


Eligibility Criteria:
Inclusion Criteria:

* Patient has been diagnosed with brain injury
* Patient is 18 years old
* Patient has self-identified as planning to enroll in an interventional clinical trial

Exclusion Criteria:

* Patient does not understand, sign, and return consent form
* Patient is pregnant
* Inability to perform regular electronic reporting
Macular Involvement in Diabetic Retinopathy Evaluated With Swept-Source OCT

This study evaluates micro-vascular changes in patients with diabetes. Results of diseased retinas will be compared to healthy controls.

The prevalence of diabetes mellitus (DM) is increasing worldwide. Diabetic retinopathy is the most prevalent complication of DM and a leading cause of visual impairment due to closure of capillaries. High-resolution imaging techniques of the retina and its supplying vascular networks can allow novel insight to subtle changes that cannot be appreciated in standard fundus examination. In this study capillary changes of patients with different severity levels of diabetic retinopathy will be investigated with non-invasive imaging technology to better understand the process of disease progression.

Imaging will be done with Optical Coherence tomography (OCT) angiography as well as spectral domain OCT and ultra wide-field imaging.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 Participants can have 1 or 2 study eyes

Patient Group:

* Diabetes mellitus type 1 or 2
* Study eye with any DR severity level: no DR, mild NPDR, mod NPDR, sev NPDR, PDR

Exclusion Criteria:

* Substantial media opacities that would preclude successful imaging

  * Active intraocular inflammation (grade trace or above) in either eye like infectious conjunctivitis, keratitis, scleritis, endophthalmitis as well as idiopathic or autoimmune-associated uveitis in either eye
  * Structural damage to the center of macula in the study eye
  * History of prior panretinal photocoagulation
  * History of treatment with intravitreal agents over the prior 6 months
  * Macular edema involving the central subfield
  * Prior history of vitrectomy
  * Atrophy of retinal pigment epithelium, subretinal fibrosis, laser scar within foveal avascular zone (FAZ) or organized hard exudate plaques
  * Substantial non-diabetic intraocular pathology in the study eye including retinal vascular occlusion, retinal detachment, macular hole, choroidal neovascularization, macula dystrophies
  * Intraocular surgery (including cataract surgery, YAG laser capsulotomy) in the study eye within 3 months preceding Day 0, or history of corneal transplantation in the study eye
  * Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 25 mmHg despite treatment with anti-glaucoma medication)or history of glaucoma filtration surgery
  * Inability to obtain fundus images of sufficient quality to be analyzed and graded
The Influence of an Orthopaedic Manual Physical Therapy and Sensory Training on Somatoperception in Patients with Chronic Low Back Pain

Individuals with chronic low back pain and other chronic pain conditions have been shown to have altered somatosensory, the ability to sense input to the tissue, which is processed in the primary somatosensory cortex or S1. Two-point discrimination is currently the best clinical tool utilized to assess an individual's ability to sense touch. This study will assess TPD changes after a course of standard physical therapy care with the addition of sensory training.


Eligibility Criteria:
Inclusion Criteria:

* DEERS eligible
* 18 to 64 years old
* Low back pain \&gt; 3 months
* Numeric Pain Rating Scale minimal pain rating of 3/10 in the last seven days
* Must be able to commit to 6-10 treatment sessions over a period of at least 6-we

Exclusion Criteria:

* History of spinal surgery
* History of spinal injections or nerve ablations in the past year
* History of traumatic brain injury (TBI)
* History of cerebral vascular accident (CVA)
* Currently pregnant
* Active cancer
* Symptoms below the knee
* Non-MSK condition contributing to low back pain
* Chronic Pain Conditions to include Chronic Regional Pain Syndrome and Fibromyalgia
* Autoimmune Diseases (to include Ankylosing Spondylitis, Lupus, Rheumatoid Arthritis)
* Currently under litigation related to low back pain
* Currently going through Medical Evaluation Board (MEB)
* Retiring or separating from the military within a year
* Currently receiving physical therapy for low back pain
AMG 827 in Subjects With Psoriatic Arthritis

The study will examine the safety and effectiveness of AMG 827 for the treatment of psoriatic arthritis

The study will examine the safety and effectiveness of AMG 827 for the treatment of psoriatic arthritis. Patients will randomly receive either AMG 827 or placebo (a look-a-like liquid that does not have any drug in it) and neither the doctor nor the patient will know what treatment is being given.

Eligibility Criteria:
Inclusion Criteria:

* Subject has had a diagnosis of psoriatic arthritis (by the Classification of Psoriatic Arthritis (CASPAR) criteria) for at least 6 months
* Subject has ≥ 3 tender and ≥ 3 swollen joints

Exclusion Criteria:

* Subject has an active infection or history of infections (systemic anti-infectives were used within 28 days; requiring hospitalization or intravenous anti-infectives within 8 weeks; recurrent or chronic)
* Significant concurrent medical conditions
* Pregnant or breast feeding
* Significant Laboratory abnormalities
* Use of sulfasalazine, hydroxychloroquine, systemically administered calcineurin inhibitors, azathioprine, parenteral corticosteroids including intramuscular or intraarticular administration, or live vaccines within 28 days
* Use of anti-TNF therapy within 2 months
* Use of an anti-interleukin (IL)12/IL-23 drug or other experimental or commercially available biologic therapies for psoriasis and/or psoriatic arthritis within 3 months
* Prior use of rituximab
* Prior use of anti-IL-17 biologic therapy, including AMG 827
The Association Between Delivered Oxygen and Cerebral Impact During the Use of Cardiopulmonary Bypass.

Investigating the connection between delivered oxygen index and cerebral impact with COx (cerebral oximetry index) och cerebral injury markers during the routine use of cardiopulmonary bypass.

The research subjects are to be treated with CPB with according to local standards (perfusion index 2.4 x body surface area). While measuring impact on cerebral autoregulation with the aid of Near InfraRed Spectroscopy (NIRS) and brain injury markers in blood, research subjects depending on initial hemoglobin value, will divide into two subgroups: one with DO2I of \>280 ml/min/m2, and one with DO2I of \<280 ml/min/m2.

DO2I will during CPB be calculated using the patient data monitoring system Metavision.

With a correlation analysis between NIRS and MAP (mean arterial pressure) a COx (Cerebral Oxymetry Index) r-value can indicate impact on cerebral autoregulation with values \>0.3 - 0.5 during use of CPB 4.

Brain injury markers (Tau, Glial Fibrillary Acidic Protein (GFAP), Neurospecific Enolase (NSE)) are collected during 5 occasions during the first 24 hours and then once per day for 4 days, as well as markers for AKI (S-Creatinine) in some extent.

Registrations during the intensive care regarding delirium, stroke or other neurological impact will also be included in the study.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for CABG and/or AVR

Exclusion Criteria:

* Former diagnosed neurological insults, carotid stenosis
A Phase IIa Study to Assess the Tolerability, Safety, and Efficacy of AZD4017 for Raised Intra-ocular Pressure

The purpose of this study is to evaluate the efficacy of systemically administered AZD4017, compared with placebo, over a 28-day period in patients with raised intra-ocular pressure (IOP).


Eligibility Criteria:
Inclusion Criteria:

* Must have a diagnosis of intra-ocular hypertension (raised IOP), or primary open-angle glaucoma (POAG), with IOP \>20 mmHg and ≤36 mmHg in the study eye, and is currently prescribed a stable dose of a single anti-glaucoma medication that began at least 30 days prior to the screening visit; OR
* Must have a diagnosis of intra-ocular hypertension (raised IOP), defined as an IOP ≥22 mmHg and ≤36 mmHg in the study eye while not on anti-glaucoma medication
* Male patients must be willing to use barrier contraception with spermicide, ie, condoms, from the day of first dosing until 3 months after dosing with IP
* Placebo treatment for duration of the study must not be considered detrimental to the patient

Exclusion Criteria:

* Have uncontrolled intra-ocular hypertension (\>36 mmHg)
* Have experienced a significant visual field loss or showed evidence of progressive visual field loss within the last year (as defined by \>1 dB/yr average loss or vision threatening new defect)
* Have had severe eye trauma at any time
A Comparison of Manual Physical Therapy and Corticosteroid Injections for Knee Osteoarthritis

The purpose of this study is to compare an orthopaedic manual physical therapy (OMPT) approach to a corticosteroid injection approach for the management of knee osteoarthritis.

The purpose of this study is to compare a commonly offered clinical approach of a series of intra-articular steroid injections to an orthopaedic manual physical therapy (OMPT) approach consisting of manually applied passive movement and reinforcing exercise for the treatment of osteoarthritis of the knee (knee OA). A second purpose is to validate a clinical prediction rule (CPR) for patients unlikely to respond to the orthopaedic manual physical therapy approach in a pre-planned secondary analysis of data from the randomized clinical trial.

Aim 1: To see if there is a significant difference in pain and function lasting out to 1 year for patients that receive a clinical approach consisting of a series of intra-articular steroid injections compared to those that receive a clinical approach consisting of orthopaedic manual physical therapy.

Aim 2: To validate a clinical prediction rule of characteristics identified in a previous preliminary study that predicted which patients with knee OA would be unlikely to respond to OMPT.

Eligibility Criteria:
Inclusion Criteria:

* All subjects must be eligible for care in the military health system
* Meet Altman's clinical criteria for knee OA
* Have English language skills sufficient to complete the WOMAC and GROC outcome instruments
* Be 38 years of age or older

Exclusion Criteria:

* Steroid injections or physical therapy treatment for their knee in the past 12 months
* Current or past history of rheumatoid arthritis or similar rheumatic condition
* Current or past history of gout or pseudogout of the knee
* Active infection in the knee within the past 12 months
* Other physical ailment or condition that is typically more limiting or painful than their knee OA during activities such as sitting, standing, walking, or stair climbing
* History of allergy or adverse effect to corticosteroids
* Cannot speak/read English adequately to understand and provide consent to participate in the study
* Pregnant or intending to become pregnant
* Military service members pending a medical evaluation board, physical evaluation board, equivalent discharge process, or on medical hold to determine long-term disposition. For non-military personnel, anyone that is pending or undergoing any litigation for this condition.
* Contraindication to receiving a corticosteroid injection (history of allergic or adverse reaction to steroid injection, history of multiple corticosteroid injections in that area even if not within last year, etc)
* Unable to give informed consent to participate in the study.
Nutraceutical Support of Fatigue Reduction, Improved Physical, Mental & Cognitive Function and Mitochondrial Function

The purpose for this protocol is to perform an open-label human clinical pilot study on the effects of consumption of two nutraceutical blends in subjects with long-term unexplained fatigue interfering with daily living.

This is an open-label human clinical study to evaluate the effects of consumption of the nutraceutical product ATP-Fuel, compared to the nutraceutical product ATP-II. The study participants will be randomized to one of three groups: consuming ATP-Fuel (5 capsules, twice daily); consuming ATP-II (3 capsules, once daily); or consuming ATP-II (3 capsules, twice daily). The study is of 8 weeks' duration, with evaluation at baseline, 1, 4, and 8 weeks of product consumption.

At each visit the following measurements and procedures are performed: Blood pressure, questionnaires pertaining to fatigue, pain and wellness, and a blood draw. The blood is used for testing of lipid peroxidation and mitochondrial volume and metabolic activity.

Eligibility Criteria:
Inclusion Criteria:

* Adult people of either gender;
* Age 18-75 years (inclusive);
* BMI between 18.0 and 34.9 (inclusive);
* Experiencing fatigue, at a level that moderately to severely interferes with daily activities, for the past 6 months.

Exclusion Criteria:

* Cancer during past 12 months;
* Chemotherapy during past 12 months;
* Currently taking blood thinning medication (81mg aspirin allowed);
* Getting regular joint injections (such as cortisone shots);
* Have received a cortisone shot within past 12 weeks;
* Major surgery within the past 3 months;
* Major trauma within the past 3 months;
* Any other significant disease or disorder that the investigator judges may put the subject at risk because of participation in the study, or may influence the result of the study;
* Known food allergies or sensitivities related to the test products;
* Participation in another research study involving an investigational product in the past month;
* Planned surgery within 2 weeks of completing the study;
* Previous major surgery to stomach or intestines \[(absorption of test product may be altered) minor surgery is not a problem, including appendix and gallbladder removal\];
* Unwilling to maintain a constant intake of supplements over the duration of the study;
* Women who are pregnant, nursing, or trying to become pregnant.