cyrilzakka/clinical-trials huggingface dataset:
Defining Strategies for Improving Endothelial and Fibrinolytic Dysfunction in Obesity

The combination of high blood pressure and having central obesity is an increasing important factor for heart disease in men and women. It can also lead to the early development of hardening of the arteries and increased risk of a stroke. This study will analyze patients' genetic make up to identify who may be at greater risk for heart disease and strokes in relationship to high blood pressure and central obesity.

Obesity is an increasingly important risk factor for cardiovascular disease in men and women and is associated with the premature development of atherosclerosis, and increased risk of stroke. A classical perspective of cardiovascular risk does not adequately explain all of the cardiovascular events associated with obesity. Elevated plasma levels of plasminogen activator inhibitor type I (PAI-1) are one of the biochemical hallmarks for obesity and likely contribute the increased risk of atherothrombotic events in patients with obesity. The central hypothesis of this proposal is that the increased risk of atherothrombotic events in patients with obesity. The central hypothesis of this proposal is that vascular PAI-1 excess promotes the development of intravascular thrombosis. We will test the hypothesis that secreted factors from adipocytes have autocrine, paracrine and endocrine effects that have a deleterious effect on the fibrinolytic system, either by enhancing PAI-1 production or impairing endothelial t-PA release. From a public health perspective, there is no greater threat to America's cardiovascular health than the epidemic of obesity. It is anticipated that this study will provide new insights nto the molecular mechanisms that contribute to the development of fibrinolytic dysfunction and cardiovascular disease in obesity.

Eligibility Criteria:
Inclusion Criteria:

* Male or females between the ages of 18 to 65 years of age.
* Documented diagnosis for the metabolic syndrome:
* Subjects with hypertension (SP\>130mmHg)
* Subjects with central obesity (females waist \>35"; males waist \>40")
* Subjects with dyslipidemia (HDL \<40mg/dl, triglycerides \> 150 mg/dl)
* Subjects who are insulin resistance (fasting glucose \>100mg/dl)

Exclusion Criteria:

* Subjects who smoke
* Women who are pregnant (confirmed by urine beta-HCG).
* Women who are breast feeding
* Subjects with documentation of the following health risk:

  * Subjects with serum creatinine \>2.0 mg/dl (males), \>1.8 mg/dl (females)
  * Subjects whose creatinine clearance \< 50 mls/min
  * Subjects with serum potassium \>5.5mEql
  * Subjects with Type 2 diabetes with microalbuminuria (spot urine protein/creatinine ration \>0.2)
* Subjects who are currently taking the following medications:
* Warfarin
To Exam the Efficacy of Oral Health and Mediterranean Diet Interventions in Preventing Cognitive Decline Among Older Adults With Mild Cognitive Impairment

At present, many literatures have confirmed that the Mediterranean diet has the effect of delaying cognitive degeneration in patients with mild cognitive impairment, and can also slow down the speed of brain atrophy. In addition to the highly respected Mediterranean diet every year, several years of foreign research have found The maintenance of oral hygiene also has a significant relationship with the decline of cognitive function. The intervention of "oral hygiene" is a new intervention method that has started in recent years. Oral health will affect the overall health status, physical function, diet and nutritional status of the elderly. In particular, older adults with poor oral health are more likely to suffer from mild cognitive impairment. The relationship between oral health and nutrition and overall health is inseparable. If the concept of healthy eating (Mediterranean diet) recognized by the public is used and oral health education is involved at the same time. To allow patients with mild cognitive impairment to maintain oral health care in daily life, and to increase the knowledge of the Mediterranean diet and try to follow the rules of the Mediterranean diet, whether there is a more significant impact on these patients.

This trial is expected to enroll 120 subjects, which will be accepted by the relevant researchers who carry out this study. In the pre-test part, all subjects will receive the Montreal Intelligence Test (MoCA) and Mini Intelligence Examination (MMSE) and collect MEDAS-14 Item, Oral Health Assessment Tool, OHAT and evaluation data of Taiwan Frailty Criteria of Taiwan. After completing the 12-week oral health and Mediterranean diet education intervention, all subjects will undergo post-test follow-up evaluation (MoCA, MMSE, MEDAS-14 item, OHAT and Frailty Criteria), and all subjects will be assessed 12 weeks after the intervention The subjects were followed up with follow-up cognitive function tracking (MoCA, MMSE, MEDAS-14 item, OHAT and Frailty Criteria). Finally, all the data were statistically analyzed to study which of the individual measures and the combined measures had a more significant cognitive effect on MCI patients.

Eligibility Criteria:
Inclusion Criteria:

1. Over or equal to 50 years old
2. CDR score is less than or equal to 0.5 or MMSE score is 24-30 (including 24 and 30)
3. Conscious/complaint of cognitive decline

Exclusion Criteria:

1. Dementia
2. Acute and significant mental illness in the past three months
3. Acute serious medical and surgical diseases in the past three months
4. Symptoms of delusions, hallucinations or delirium in the past three months
5. Severe visual and hearing impairment in the past three months
6. Other conditions that make the patient unable to cooperate: such as not being suitable after screening, not signing the subject's consent form.
The Arthroscopic Labral Excision or Repair Trial (ALERT)

This study compares two established surgical treatments for acetabular labral tears. Patients will be prospectively recruited and randomised to either labral repair or debridement. All patients will be followed for 2 years after intervention with a primary outcome assessment at 6 months.

STUDY DESIGN

Study design This will be a two-arm randomised controlled parallel group superiority study and will take place in a hospital setting. Stratification will be performed for sex and age by means of a minimisation technique during randomisation for each subject entering the trial.

Study population:

Adults between 18 and 75 years of age diagnosed with symptomatic acetabular labral tears demonstrated on MRI arthrogram but without radiographic evidence of OA ie: Kellgren \& Lawrence grade less than 2 randomly selected from the Nuffield Orthopaedic Centre outpatient clinics.

Arm 1 Arthroscopic acetabular labral repair.

Arm 2 Arthroscopic acetabular labral resection

48 patients per arm (total 96 patients) will be selected from outpatient clinics and the operative waiting list (pre-operative assessment clinics) at the Nuffield Orthopaedic Centre, Oxford. The surgeries will be conducted using routine instrumentation in use at the centre.

STUDY PROCEDURES

Recruitment

All patients will undergo surgery in accordance with established practice regardless of their treatment allocation. Arthroscopy will be performed using standard anterior and lateral portals for insertion of instruments. All patients will undergo arthroscopic evaluation of the entire joint. Subsequent procedures will vary according to treatment allocation:

* Arm 1 - Labral Repair - acetabular labral tear will be identified and reattached using suture anchors until a stable repair is achieved. If evidence of FAI is present ie: a cam or pincer lesion is identified then this will be treated with osteochondroplasty (cam) or acetabular rim recession (pincer).
* Arm 2 - Labral Resection - the acetabular labral tear will be identified and its' limits defined. The torn portion of labrum will be resected to a stable edge. As with arm 1 there will be treatment of FAI if identified.

Eligibility Criteria:
Inclusion Criteria:

* Willing and able to give informed consent for participation in the study.
* Male or Female, aged between 18 and 75 years.
* Symptomatic labral tear with evidence of labral tear on MRI.
* No radiographic evidence of OA (Kellgren-Lawrence Grade \< 2)

Exclusion Criteria:

* Previous ipsilateral hip surgery
* Irreparable labral tear
* Previous fracture of femoral neck or acetabulum
* Female patient who is pregnant
* Established osteoarthritis (Kellgren-Lawrence ≥ 2)
* Hip dysplasia
The Safety and Efficacy Test of Immuncell-LC to Treat Refractory Metastatic Colorectal Cancer

This study aims to evaluate the safety and efficacy of Immuncell-LC, the adoptive immuntherapeutic agent composed of a CIK cell agent, to treat patients with metastatic colorectal cancer, which are refractory to the 3rd-line chemotherapeutic agents.

All enrolled patients received the 12 times of Immuncell-LC therapy: 8 times in every 1 week and 4 times in every 2 weeks.

Stage IV colorectal cancer(CRC) has poor survival rate in spite of the development of chemotherapeutic agents. It is regarded as a standard palliative chemotherapy using with both targeted agents and cytototic chemotherpeutic agents. However, it is still demanding to treat stage IV CRC patients, who are refractory responses in these chemotherapeutics. In addition, patients were suffered from the various adverse events by the repetive cytotoxic chemotherapies.

Eligibility Criteria:
Inclusion Criteria:

* At least 19 years old
* Clinical diagnosis of metastatic colon cancer or rectal cancer
* ECOG ≥ 2
* ASA ≤ 3
* Patients should meet below conditions by serologic test, kidney and liver function test: Re-evaluation is permitted during screening.

  * Absolute neutrophil count (ANC) ≥ 1500/μL
  * Hemoglobin level ≥ 9.0 g/dL
  * Platelet count \>75,000/μL
  * BUN and serum Creatinine are less than or equal to 1.5 multiply normal upper-limit
  * AST and ALT are less than 2.5 multiply normal upper-limit (If a patients has liver metastases, AST and ALT are less than 5 times of normal upper-limits.)

Exclusion Criteria:

* Patient who has disease history of immune deficiency or auto-immune disease (ex. Multiple sclerosis, arthritis rheumatism, Buerger's disease, and adolescent-occurred insulin dependent diabetes)
* Pateint who diagnosed immune-deficiency diseases
* Diagnosis of malignant tumor within 5 years before this clinical trial. (except for skin cancer, local prostate canter or carcinoma in situ of the cervix
* Patient who needs interventional therapy due to intestinal obstruction of obstructive jaundice
* Diagnosed status of infection or sepsis
* Uncontrolled hypertension or heart-failure
* Severe allergic history, which is diagnosed by sub-investigators
* Serious psychologic disease, which is diagnosed by sub-investigators
* Pregnant women, nursing mother or people who has intention of being preganant during the clinical test
* Patient who participated in other clinical trials within last 4 weeks before this trial
A Two-Arm Study Comparing the Analgesic Efficacy and Safety of Acetaminophen and Tramadol Combination BID Versus Placebo for the Treatment of Acute Low Back Pain

A multi-center placebo controlled, double-blind, trial comparing the analgesic efficacy and safety of Acetram Contramid® BID versus placebo for the treatment of acute low back pain in patients between 18 and 80 yrs of age.


Eligibility Criteria:
Inclusion Criteria:

* Males or females in generally good health aged 18-80 years with moderate to severe acute low back pain.
* Current acute low back pain episode within 48h prior to study entry.
* Pain must be moderate to severe following incident

Exclusion Criteria:

* Chronic low back pain
* Ongoing or history of alcohol or drug abuse
* Body Mass Index greater 39
* Treatment within the last 3 weeks with monoamine oxidase inhibitors; tricyclic antidepressants and other tricyclic compounds; neuroleptics; selective serotonin reuptake inhibitors
* Known history or symptoms suspicious for cancer
* Significant renal or liver disease
* Spinal surgery within 1 year of study entry.
* Subjects who are pregnant or lactating.
* Subjects with unstable medical disease.
* Subjects who have received treatment with an investigational product/device with 30 days prior to study entry.
Longitudinal Analysis of the Vaginal Microbiome

This is a longitudinal, observational study with the goal of understanding vaginal microbiome changes both within a single day and across a menstrual cycle. The study will be composed of at least 10 women that have regular menstrual cycles and are 18 years of age or older. This study is direct to participant and will NOT utilize clinical sites.

Eligible women will be recruited into the study. They will be consented and asked to complete a health questionnaire. On six separate days during two menstrual cycles, they will be asked to collect vaginal swab samples (total of 12). For each sample collection, they will answer the sample collection questionnaire. Samples will be returned to Viome labs for analysis.

Eligibility Criteria:
Inclusion Criteria:

* Biological sex is female
* Willing to collect own vaginal samples
* Willing to answer health questions
* Experience menstrual cycles regularly (a monthly cycle)

Exclusion Criteria:

* Pregnant
* Antibiotic use in the past 3 months
Effect of Nephrostomy on Relative Function of Obstructed Kidney

Urinary tract obstruction is a serious health problem due to kidney damage. Relative renal function has an important role in the treatment of obstructed kidneys. Nephrectomy can be recommended when the relative renal function is 10% or less in radionuclide examinations. Recently, however, nephron sparing approaches have come to the fore. This indicated the need to evaluate the possibility of recovering the function of the kidney before nephrectomy. The aim of this study is to compare relative functions of obstructed kidneys in technetium 99m dimercaptosuccinic acid scintigraphy (DMSA) before and 2 weeks after nephrostomy tube.

Obstructive uropathy is one of the most important causes of acute renal injury and end-stage renal failure. obstruction of urine flow increases the intratubular pressure. This pressure increase causes decrease in renal blood flow and starts the inflammatory process. In the first few hours after total ureter obstruction, due to the increase in intratubular pressure glomerular filtration ceases and tubular transport is markedly decreased. Long lasting obstruction results in renal fibrosis and end stage renal damage. Basically obstructive uropathy leading to irreversible renal damage and loss of renal function is the main indication for simple nephrectomy. Serious renal parenchymal damage is defined as non-functioning kidney having relative renal function (RRF) 10% or less in the literature. But recently in some studies it was suggested that by applying the nephrostomy catheter, ability of kidney to regain function can be evaluated before nephrectomy. So, possibility of gaining function should be kept in mind. In this study effect of percutaneous nephrostomy tube on serum creatinine, blood urea nitrogen (BUN) and RRF in obstructed kidney with RRF 10% or less. Before and 2 weeks after percutaneous nephrostomy, serum creatinine, ure and RRF in DMSA was recorded and compared.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral obstructed kidney with RRF 10% or less
* Unilateral obstructed kidney with grade 2 or more hydroureteronephrosis
* Defined etiology for unilateral obstructed kidney
* estimated glomerular filtration rate (GFR) ≥ 30ml/min
* Approving the nephrostomy procedure

Exclusion Criteria:

* Unilateral obstructed kidney with RRF above 10%
* Estimated GFR \<30 ml/min
* diagnosis of bilateral obstructed kidneys
* not approving nephrostomy
Predictive Model to Calculate the Risk of RBC Transfusion in Elective Brain Tumours Resections (TScoreBTR)

To validate a predictive model for the risk of receiving RBCs in this population. This model uses four preoperative values (haemoglobin levels, tumour volume, previous craniotomy in the same spot, and number of craniotomies foreseen). The investigators would like to create an online data collection tool and calculator.

Observational study collecting data from different institutions and teams groups in Spain. The investigators aim at validating one model (published in Journal of Neurosurgical Anesthesiology) in different settings and populations to see if it can be accurately used to provide an opportunity to optimize both the patient and the surgical plan as well as to guide perioperative crossmatch and RBC orders.

Inclusion criteria - Brain tumour (primary or metastatic) patients undergoing craniotomy for resection.

Exclusion criteria Patients younger than 18 years old. Urgent/emergent surgery. Brain tumours not requiring full craniotomy. Patients with blood conditions causing coagulation abnormalities. Systemic disease associated with significant abnormalities in coagulation times (prothrombin time \<60% or activated thromboplastin time \> 50 sg).

Outcome The investigators aim at developing objective and simple criteria about the probability of requirements RBCs during a brain tumour resection surgery. This way we could create a simple tool that would help to optimize both the patient and the surgical plan as well as to guide perioperative crossmatch and RBCs orders.

Statistical Analysis

Transfusion requirement predictive probability will be calculated as follows:

〖1/(1+e〗\^(-(5.7606 + \[-0.7037\*(PH in g/dL)+ 0.0103\*(BTLTV in mm3)+ 1.0558\*(NC)+ 0.6232\*(PC)\]))) PH: Preoperative haemoglobin; BTLTV: brain tumour lesions total volume; NC: craniotomies number; PC: previous craniotomy. NT=1 if NT\>1, or 0; PC=1 if PC at the same site for resection (not only biopsy), or 0. Model discrimination and calibration will be assessed with area under ROC curve, and Hosmer-Lemeshow test with calibration plot, respectively. P\<0.05 will indicate statistical significance.

Eligibility Criteria:
Inclusion Criteria:

- Brain tumour (primary or metastatic) patients undergoing craniotomy for resection.

Exclusion Criteria:

* Patients younger than 18 years old.
* Urgent/emergent surgery.
* Brain tumours not requiring full craniotomy.
* Patients with blood conditions causing coagulation abnormalities.
* Systemic disease associated with significant abnormalities in coagulation times (prothrombin time \<60% or activated thromboplastin time \> 50 sg).
Automated Arthritis Detection Using Artificial Intelligence on Smartphone Photographs

The investigators are testing the ability of convolutional neural networks (CNNs), that is artificial intelligence, on smartphone photographs in detecting inflammatory arthritis. This promises to be an efficient, accurate, and non-invasive diagnostic tool that will significantly improve early detection and management of inflammatory arthritis.

Over the past 4 years the investigators have aimed to help the early detection of arthritis leveraging artificial intelligence. This project aims to detect arthritis based on smart phone photographs of joint areas that make it scalable and available in the community. This group first developed a compelling proof-of-concept pipeline and models using 100 patients. (published in Frontiers in Medicine, Nov 2023, wherein they demonstrated that this technology works with reasonable accuracy in the lab, viz Technology Readiness Level currently stands at 3-4). They followed with a newer paper (submitted for publication, available on preprint server MedRxiv) that trained two different CNNs, a screening CNN on uncropped hands that distinguishes patients from controls followed by joint specific detections.

The system involves supporting infrastructure that will enable efficient detection of arthritis. This includes

1. Collection of photos in a standardized manner using custom designed boxes
2. Using and testing a browser pipeline
3. The CNN models will be trained on the dataset of photographs taken in this and results will be deployed to doctors in the community. This ensures a doctor in the loop that can later take action on the results for further confirmatory tests or management.
4. Understanding knowledge, attitude of patients and doctors towards AI in clinical decision making algorithms

This is a Prospective, non-interventional study and this project only involves an investigator taking a smartphone photograph of some joint areas kept in standardized positions. This involves no risk to the patient.

Eligibility Criteria:
Inclusion Criteria:

* Inflammatory arthritis of any etiology

Exclusion Criteria:

* Severe deformity that hampers standardization of photographs
An Adaptive Randomized Controlled Trial

This is a prospective, adaptive, randomized controlled trial comparing the effectiveness of 4 intervention arms on a combined endpoint in adults with confirmed MDR-TB HIV initiating Bedaquiline-containing MDR-TB treatment regimens and on ART (integrase strand transfer inhibitor (INSTI)-based fixed dose combination therapy) in KwaZulu-Natal, South Africa. Interventions arms include: enhanced standard of care; psychosocial support; mHealth using cellular-enabled electronic dose monitoring; combined mHealth psychosocial support. Level of support will be adjusted using a differentiated service delivery (DSD)- informed assessment of treatment support needs.

This study will follow a 4-arm Bayesian, adaptive trial design. As patients are enrolled, they will be randomized into one of the four arms.

The study will be carried out within a common structure to allow for efficient enrollment and analysis. The overall structure is a 4-arm adaptive platform of mHealth and psychosocial adherence support interventions informed by a differentiated service delivery (DSD) approach.

Aim 1 is an adaptive study of mHealth and psychosocial adherence support interventions using a Bayesian adaptive design to allow comparison of elements of the intervention separately and in combination. Aim 1 participants will be randomized into one of 4 arms and followed monthly through the 6 months of intervention, then through the end of treatment telephonically, with an additional in-person visit to establish the primary outcome. Primary outcome is a combined clinical/biological outcome at 12 months described below. Hypothesis 1a utilizes all participants while 1b utilizes only those in the mHealth intervention arms (3+4) since granular EDM-measured adherence is required.

Eligibility Criteria:
Inclusion Criteria:

1. Culture or molecular test positive for MTB
2. Molecular test positive for HIV or a documented HIV positive history
3. Drug-susceptibility testing by molecular (i.e. GeneXpert MTB/RIF) or conventional testing consistent with at least rifampicin-resistant TB,
4. Initiating treatment with a Bedaquiline -containing TB regimen within 4 weeks of enrollment and first-time being treated with BDQ
5. On treatment with Antiretroviral Therapy (ART) regimen, including dolutegravir-containing combination Antiretroviral Therapy regimen (i.e. Tenofovir-Lamivudine-Dolutergravir), or starting within 4 weeks of enrollment,
6. Capacity for informed consent in either isiZulu or English

Exclusion Criteria:

1. Pregnancy
2. Prisoners
3. Discretion of IOR or clinician