cyrilzakka/clinical-trials huggingface dataset:
The Correlation Between Hair Cortisol Level of Acute Stroke or Its Long Term Disability.

In patients admitted to hospital with acute cerebrovascular stroke, we want to study the relationship between hair cortisol levels and biomarkers of inflammation and the clinical and radiological severity of the stroke and the degree of neurological disability being tested in three months and one year after.

The study will include patients hospitalized due to an acute cerebrovascular stroke. A number of 30 patients aged 40-70 will be included. Within 48 hours of the event, blood inflammatory biomarkers, and scalp hair sample for cortisol will be taken. All recruited patients will undergo full neurological examination and the severity of the stroke will be rated using NIHSS (National Institutes of Health Stroke Scale). 3 months and one year later neurological examination and rating of neurological disability will be determined using Rankin Scale.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 40-80.
2. Acute cerebrovascular stroke (symptoms that began no more than 72 hours before)
3. Rankin 0-1 before the event

Exclusion criteria:

1. Suspicion or known Cushing's syndrome
2. Known adrenal failure
3. Chronic inflammatory disease
4. Active malignancy
5. Acute infectious disease within 4 months before enrollment
Prophylaxis With Single Versus Five Dose of Antibiotic Therapy as Treatment of Patients With Gangrenous Acute Appendicitis

A prospective, randomized controlled clinical trial was conducted at the Hospital Universitario de Santander to test the effectiveness of providing a single 1-dose therapy of antibiotic prophylaxis versus a 5-day antibiotic therapy in patients with acute gangrenous appendicitis.

Introduction: For patients with acute gangrenous appendicitis, it is common to provide antibiotics during 5-7 days in order to reduce the incidence of infection of the surgical wound; however the benefit of such treatment has not been tested. A prospective, randomized controlled clinical trial was conducted at the Hospital Universitario de Santander to test the effectiveness of providing a single 1-dose therapy of antibiotic prophylaxis versus a 5-day antibiotic therapy in patients with acute gangrenous appendicitis.

Materials and Methods: From December 2007 to November 2009, 799 patients went through surgery after being diagnosed with acute appendicitis. Out of this set, 150 patients diagnosed with acute gangrenous appendicitis, were randomly assigned to one of two groups: control group (group A: 72 patients received a 5-day antibiotic therapy), and treatment group (group B: 78 patients received a single 1-dose of antibiotic prophylaxis). The experimental outcomes included: the incidence of infection of the surgical wound, the length of the hospital stay, and the adverse effects derived from a prolonged use of antibiotics.

Eligibility Criteria:
Inclusion Criteria:

* patients with diagnosis of acute appendicitis with intraoperative finding of a gangrenous appendix who accepted to enter the study

Exclusion Criteria:

* patients under 12 or older 65 years old
* Patients with possible immunosuppression such as diabetes, cancer, kidney failure, liver failure
* Pregnancy
* Patients who have received antibiotic treatment within seven days before surgery
* Patients difficult to monitor or follow up
Exercise Adherence in Home-based Cardiac Rehabilitation

The study will investigate the influencing factors of exercise adherence of home-based cardiac rehabilitation in patients with coronary artery disease.

The study will conduct a quantitative questionnaire survey. Patients with coronary artery disease in home-based cardiac rehabilitation will receive investigation of the influencing factors of exercise adherence.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of coronary artery disease;
* Age ≤75 years old;
* Participated in home-based cardiac rehabilitation ≥12 weeks;
* Volunteer to participate in this study.

Exclusion Criteria:

* Have other serious acute or chronic diseases;
* Have severe audio-visual or speech impairments that may affect understanding and answering questions.
Efficacy and Safety Study of Dietary Supplements in Chronic Smokers Having Mild to Moderate Hyperlipidemia

The purpose of this study is to investigate the efficacy and safety of dietary supplements (BioTurmin, BioTurmin-WD and MaQxan) on cotinine level and oxidative stress marker in chronic smokers having mild to moderate hyperlipidemia after 30 days of intervention.

In a randomized, double-blind, placebo control trial, the efficacy and safety of dietary supplements (BioTurmin, BioTurmin-WD and MaQxan) will be investigated in chronic smokers having mild to moderate hyperlipidemia. Sixty subjects will be randomly assigned to receive the dietary supplements and placebo for 30 days. The efficacy of the supplements will be measured by estimating cotinine and malondialdehyde level.

Eligibility Criteria:
Inclusion Criteria:

Men \> 20 years

Chronic cigarette/ beedi smoker (2-3 packets/day since last 3 years or more) with mild to moderate hyperlipidemia (LDL ranging 160-189 mg/dL, TC \>200 mg/dL and/or HDL-C \<40 mg/dL)

Being mentally competent and able to understand all study requirements and sign the informed consent form.

Exclusion Criteria:

Patients with Chronic obstructive pulmonary disease (COPD)

Women

Patients with severe liver, renal, cardiac or brain diseases.

Unable to complete follow up.

Subjects on any medication like diuretics.

Allergic to any medication.

With a history of alcohol and/or drug abuse.
One Way to Diagnose Hepatic Insufficiency the First Postoperative Day After Resection: Prospective Cohort Study

Introduction: Hepatic insufficiency is a complication that puts the life of the patient undergoing resective surgery at risk. Thus, the diagnosis should be made early. The current gold standard allows its diagnosis on the fifth postoperative day.

Indocyanine green is a water soluble dye. When administered intravenously, it binds to plasma proteins and it is removed unchanged by bile, without experiencing enterohepatic recirculation, which allows estimating the function of hepatocytes and the function of hepato-splacnic flow. There is a measurement system named "Non-invasive liver function monitor" (LiMON®, PULSION Medical Systems, Munich, Germany), which allows the measurement of indocyanine green clearance at the patient's bedside.

Justification: The use of indocyanine green plasma disappearance during the perioperative period tries to know the exact value of the hepatic function in the most real conditions, when the excision has been performed, thus giving the investigators the actual value of the unresected liver. This allows te investigators to estimate the risk of hepatic insufficiency development that can lead to hepatic failure. Due to the characteristics of the test, it could get reliable results earlier than the current "gold standard " (50:50 Criteria on the 5th postoperative day).

Hypotheses and Objectives: The investigators hypothesized that the determination of the hepatic reserve by identifying the indocyanine plasma clearance in real time after hepatic parenchymal resection could lead to a more accurate and earlier statement of the hepatic reserve than current tests.

The aim of the study is to determine the usefulness of indocyanine green in the perioperative period to early diagnosis of hepatic failure.

Materials and Methods: A prospective observational post-authorization study (EPA-SP) is performed to study de usefulness of indocyanine green. The study was approved by the Ethics and Clinical Research Committee of the University General Hospital of Ciudad Real. Surgical patients scheduled for liver surgery, who agreed to be included in the study and signed an informed consent, were included in the study over a two-year period, after having understood the study objectives and its possible complications.

Measurements were performed with the LiMON® monitor prior to liver resection and on the first postoperative day to patients undergoing liver resection surgery and compared with gold standard.


Eligibility Criteria:
Inclusion Criteria:

* Patients susceptible of receiving Surgical treatment
* Liver Disease with Surgical Indication
* Adulthood
* Accept Inclusion

Exclusion Criteria:

* History of Hypersensitivity to Indocyanine Green or Iodine
* Thyroid Pathology
* Underage Status
* Pregnant
* Irresectable Tumors
NGS for Non-unions

The purpose of this study is to investigate the role of genetic testing to look for possible infection as a cause for failure of non-healing fractures. The study aims to compare the results of genetic testing known as NGS to standardized clinical laboratory tests for diagnosing infections to see if NGS may be a better diagnostic tool.


Eligibility Criteria:
Investigational group:

Inclusion:

1. Patients undergoing open biopsy / surgical intervention for nonunion following a traumatic (open or closed) long bone fracture (femur shaft, tibia, humerus) which was initially treated operatively.Inclusion Criteria:
2. Nonunions will be defined as a failure to progress towards expected union within an anticipated timeframe, and this judgment will be made by the attending caring for each patient. No specific timeframe or arbitrary cut points will be defined to allow for the considerable variation in fracture healing and different anatomical sites.
3. Presumed Septic and Aseptic nonunions
4. \>18 years old and able to provide informed consent

Exclusion Criteria:

Exclusion:

1. Pathological fractures at index injury
2. Patients on antibiotic therapy \<2 weeks prior to surgery

INCLUSION/ EXCLUSION CRITERIA FOR CONTROL GROUP:

Inclusion:

1. Patients undergoing surgical intervention for nonunion following a traumatic closed long bone fractures (femur shaft, tibia, humerus)
2. \>18 years old and able to provide informed consent

Exclusion:

1. Pathological fractures at index injury
2. Patients on antibiotic therapy \<2 weeks prior to surgery
Conservative Treatment of Early Adhesive Capsulitis

A prospective, multicentre, randomized controlled study comparing the efficacy of conservative treatment for early adhesive capsulitis

This clinical trial evaluated the most common protocols for the treatment of adhesive capsulitis in secondary hospitals. To compare the efficacy of manipulation under anesthesia and supervised home conservative treatment of early adhesive capsulitis.

Eligibility Criteria:
Inclusion Criteria:

* Patients in our hospital who need manual release of periarthritis of shoulder or home rehabilitation treatment;
* Unilateral and primary periarthritis of shoulder
* Age ≥40 years old and ≤80 years old, regardless of gender.
* Forward flexion movement is more than 50% limited compared with the contralateral.
* Duration of disease ≤3 months

Exclusion Criteria:

* Patients with a previous history of shoulder joint surgery
* Patients who did not complete the follow-up within the specified time
* Patients with other shoulder diseases.
* Patient with systemic immune disease.
* Patients who have participated in clinical trials or are conducting other clinical trials within 3 months before screening
* Patients with serious primary cardiovascular diseases, lung diseases, endocrine and metabolic diseases, or serious diseases affecting their survival, such as tumor or AIDS, are considered not suitable for admission.
* Patients with serious liver diseases, kidney diseases, hematological diseases, such as kidney function (BUN, Cr) more than the upper limit of normal, liver function (ALT, AST, TBIL) more than 2 times the upper limit of normal.
* Patients with viral hepatitis, infectious diseases, abnormal blood coagulation mechanism and other diseases that researchers consider inappropriate for surgery.
* Pregnant or lactating women, or those planning to get pregnant during the test, with positive urine HCG test results before the test; Menstruating women should wait until their period is over before undergoing surgery.
* Patients with severe neurological and mental diseases.
* Suspected or true history of alcohol and drug abuse.
Tailoring Upper Limb Exercise Advice for People With Parkinson Disease

The investigators will explore the impact of hand cycling, on hand function in people with Parkinson's Disease (PD). The study will compare the effects of two different hand cycling approaches-steady-state and interval efforts-on improving hand dexterity in people with PD. Conducted as a clinical trial, it aims to understand if a single session of hand cycling can temporarily enhance hand function and if the nature of the exercise influences the benefit.

The purpose of this study is to examine the effects of hand cycling, an upper limb aerobic exercise, on hand function in individuals with Parkinson's Disease (PD).

Parkinson's Disease affects motor skills, including hand dexterity, which can impede daily activities. While aerobic exercise is known to have benefits for people with PD, the specific impact of upper limb exercises like hand cycling on hand function is less studied. Previous research suggests aerobic exercises can improve symptoms and motor function in PD. This study aims to fill the gap in understanding how hand cycling affects hand dexterity in PD. There is no placebo involved in this study as it compares two active intervention types: steady-state and high-intensity interval hand cycling.

This is a block randomized parallel group clinical trial involving a single session of exercise intervention. Participants will be randomly assigned to one of two groups: steady-state or high-intensity interval hand cycling. The study includes baseline assessments, the exercise intervention, and post-intervention assessments to evaluate changes in hand function.

The primary endpoint is the time to complete the 9-hole pegboard test with the clinically more affected hand. Secondary endpoints include changes in motor examination scores, finger tapping speed, and subjective measures of exercise perception. Analysis of covariance will be used to compare the primary outcome between groups, accounting for baseline performance and clinical characteristics. The planned sample size is 20 people with PD, aiming to capture varied clinical expressions of the disease.

Eligibility Criteria:
Inclusion Criteria:

* Adults over 19 with a clinical diagnosis of PD.

Exclusion Criteria:

* Medical contraindication to aerobic exercise, such as unstable cardiovascular disease, or physical disability that precludes arm exercise.
* Individuals will be excluded if, upon screening with the Canadian Society for Exercise Physiology (CSEP) Get Active Questionnaire and International Physical Activity Questionnaire Short Form (IPAQ-SF) a need for further evaluation before exercise is identified
A Clinical Trial for the Treatment of Depression With Repetitive Transcranial Magnetic Stimulation (rTMS)

The purpose of this study is to determine whether the Cervel Neurotech rTMS device is safe and effective in the treatment of depression in people who do not get better with antidepressant medications or cannot take antidepressant medications.


Eligibility Criteria:
Inclusion Criteria:

* Current major depressive disorder (MDD)
* Resistance or intolerance to antidepressant medication in the current depressive episode, or intolerance to antidepressant medication in a past depressive episode
* On a stable psychotropic regimen prior to screening and be willing to maintain the current regimen and dosing for the duration of the study
* Weight less than 350 pounds

Exclusion Criteria:

* Current major depressive disorder episode of more than three years
* Seizure disorder
* History of brain injury, stroke or active central nervous system disease
* Cardiac pacemaker, implanted device (deep brain stimulation) or metal in the brain, cervical spinal cord, or upper thoracic spinal cord unless deemed MRI-safe
* Active suicidal intent or plan
* Other significant psychiatric disorder
* Alcohol or substance dependence or abuse
* Prior treatment with transcranial magnetic stimulation
* Have failed to clinically remit to an adequate trial of electroconvulsive therapy or vagus nerve stimulation
* If female, pregnant or lactating or planning to become pregnant within the next three months
Iron Administration Via Colonic TET Combined With WMT for ID

The colon can absorb iron.We propose an integrated approach utilizing colonic transendoscopic enteral tubing to deliver iron in different valence states, coupled with washed microbiota transplantation . This clinical trial aims to assess the feasibility, safety, and efficacy of this approach for the treatment of iron deficiency.

At least 60 subjects who meet all the inclusion criteria but do not meet any exclusion criteria will be enrolled in this study. Data of demographic characteristics, reticulocyte hemoglobin, ferritin and clinical outcomes will be collected. After treatment, they will enter the follow-up period for safety and efficacy evaluation.

Eligibility Criteria:
Inclusion Criteria:

1. ferritin ≤30 μg/L;
2. feasible colonic TET placement (cephalic end in the ileocecal region);
3. completion of 3 WMT sessions.

Exclusion Criteria:

1. The patient has other co-morbidities that can lead to iron deficiency, such as acute gastrointestinal haemorrhage and menorrhagia.etc.
2. People who are allergic to iron or taking oral medications that interfere with iron absorption.
3. Patients with heart, brain, lung, liver, kidney and other serious diseases;
4. Patients do not cooperate to complete the clinical trial process;
Modeling Mood Course to Detect Markers for Effective Adaptive Interventions- Aim 3

This study is a 6-week micro-randomized trial investigating the feasibility of a mobile health platform. Its long-term objective is to develop a mobile health platform for the translation of a psychosocial intervention for bipolar disorder (BP) into an effective and evidence-based adaptive intervention. In this aim of the study, investigators will evaluate how individuals with BP respond to a microintervention based in acceptance and commitment therapy (ACT) that is delivered with a mobile app.

Bipolar (BP) disorder is a chronic illness of profound shifts in mood ranging from mania to depression. BP is successfully treated by combining medication with psychosocial therapy, but care can prove inadequate in practice. With gaps in coverage and medication, along with imprecise guidelines on when, where, and how to intervene, promising psychosocial therapies require adaptive strategies to better address the specific needs of individuals in a timely manner. However, To accomplish this, evidence based practices are needed. This project aims to address this knowledge gap by establishing a mobile health platform for translating a psychosocial therapy in BP into an effective adaptive intervention.

The research to be conducted under this protocol falls under the general heading of a micro-randomized trial. It investigates feasibility of a study on how to tailor an intervention based on acceptance and commitment therapy (ACT) when delivered via a smartphone app. Long-term objective of this study is to develop a mobile health platform for the translation of a psychosocial intervention for bipolar disorder (BP) into an effective adaptive intervention. In this particular part of the study, the investigator will assess the feasibility of a mobile health and wearable device platform for the translation of a BP psychosocial therapy into an evidenced-based adaptive intervention. To answer this question, investigator will study how individuals with BP respond to a microintervention delivered via a mobile app. Primary outcome of this study is to evaluate the feasibility of a micro-randomized trial in ACT in terms of completion of assessments (interview and self-report), wearing of Fitbit, and completion of microintervention questions. Secondary outcome of the study is to detect a linear effect in time of the microintervention on symptom levels of mania and depression in individuals with bipolar disorder. The estimated linear effect would be used to power a larger study.Enrollment is by invitation only; participants in the study will be recruited from the Prechter Longitudinal Study of Bipolar Disorder (HUM606).

Eligibility Criteria:
Inclusion Criteria:

* Individuals diagnosed with Bipolar Disorder
* have agreed to be contacted for future research
* have a smart-phone
* have a diagnosis of bipolar disorder.

Exclusion Criteria:

-
Effects of Basic Body Awareness Therapy on Pain, Sleep, Disability and Quality of Life in Chronic Low Back Pain

Chronic low back pain is a common problem worldwide. In treatment, conservative methods usually are used. Basic Body Awareness Therapy is related to mindfulness-based therapies and meditation techniques. It is a method that has been used and found effective in some diseases affecting the musculoskeletal system. Therefore, in this study, body awareness was applied in addition to conventional treatment in patients with chronic low back pain.

Throughout a lifetime, chronic low back pain is a common problem that affects approximately 80% of people. Among musculoskeletal system problems, it is one of the most commonly observed issues. There are various treatment methods available. The absence of evidence-based treatment guidelines negatively affects the choice of treatment to be applied. There are medical and conservative treatment options. These methods include acupuncture, transcutaneous electrical nerve stimulation, injection therapy, non-steroidal anti-inflammatory drugs, and lumbar supports. Basic Body Awareness Therapy is a physiotherapy treatment method that has been developed in the Scandinavian countries over the course of the last two decades. This innovative approach focuses on enhancing body awareness and has gained recognition as an effective therapeutic technique in the field of physiotherapy. Basic Body Awareness Therapy has been applied as a secondary treatment method in various conditions such as fibromyalgia, neck pain, and ankylosing spondylitis, and has been found to be effective. It has yielded positive results when used in addition to conventional treatments for musculoskeletal problems, as demonstrated in the literature. This study aims to apply Basic Body Awareness Therapy to individuals with chronic low back pain, based on its effectiveness in musculoskeletal issues, and create a new treatment combination. Twenty-eight patients were included in the study, and in addition to the standard treatment protocol, Basic Body Awareness Therapy exercises were administered.

Eligibility Criteria:
Inclusion Criteria:

* Having low back pain for 3 months or more
* Being between the ages of 18-65
* Not having received any back-related treatment before
* Volunteer to participate in the study

Exclusion Criteria:

* Pregnancy
* History of tumor / metastatic disease
* History of spinal trauma, spinal cord injury
* History of infection
* Presence of congenital deformity in the spine
* History of previous spinal surgery
* Having a neurological disease (Alzheimer's, Amyotrophic Lateral Sclerosis, Multiple Sclerosis, Parkinson's, Stroke)
* Having musculoskeletal problems other than low back pain (rheumatoid arthritis, pathological fractures, avascular necrosis or osteonecrosis, severe osteoarthritis, spondylo-arthropathy)
* Patients who received a physiotherapy rehabilitation program in the last 6 months