cyrilzakka/clinical-trials huggingface dataset:
The Relationship Between Systemic Immune Inflammation Index and Disease Activity in Patients With Ankylosing Spondylitis

In this study, the aim was to investigate the relationship between SII and other laboratory parameters with disease activity in AS patients and to discuss its usability in the follow-up and treatment process.

This study aimed to investigate the relationship between the systemic immune inflammation index (SII), platelet-to-lymphocyte ratio (PLR), neutrophil-to-lymphocyte ratio (NLR), and disease activity and functional status in patients with ankylosing spondylitis (AS). A cross-sectional clinical study was conducted, and a total of 90 patients diagnosed with AS according to the Modified New York Criteria, aged between 18 and 65, who presented to our outpatient clinics were included in the study. Demographic data, disease duration, age at symptom onset, and laboratory parameters, including platelet, neutrophil, basophil, eosinophil, lymphocyte counts, mean platelet volume (MPV), red blood cell distribution width (RDW), C-reactive protein (CRP), and erythrocyte sedimentation rate (ESR), were recorded. NLR and PLR values were calculated. The Systemic Immune Inflammation Index (SII) was calculated by dividing the product of neutrophil and platelet counts by the lymphocyte count. We investigated all of these parameters and disease activity scores. Disease activity was assessed with the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), spinal mobility with the Bath Ankylosing Spondylitis Metrology Index (BASMI), and functional status with the Bath Ankylosing Spondylitis Functional Index (BASFI). In addition, during the routine follow-ups of patients, requested blood tests were examined, and platelet, neutrophil, basophil, eosinophil, lymphocyte counts, mean platelet volume (MPV), RDW (red blood distribution width), CRP, and ESR values will be recorded. Neutrophil-lymphocyte ratio (NLR), platelet-lymphocyte ratio (PLR), and systemic immune inflammation index (SII) were calculated

Eligibility Criteria:
Inclusion Criteria:

* Patients between the ages of 18 and 65 who have been diagnosed with Ankylosing Spondylitis according to the Modified New York Criteria, have applied to the Istanbul Physical Medicine and Rehabilitation Training and Research Hospital outpatient clinic on the specified dates, meet the exclusion criteria, and have complete blood count, CRP, and ESR values in their hospital records.

Exclusion Criteria:

* Presence of acute or chronic infection

  * Presence of autoimmune diseases other than Ankylosing Spondylitis
  * Pregnancy
  * Diabetes
  * Chronic kidney disease
  * Chronic liver disease
  * Malignancy
  * Cardiovascular disease
  * Hematological disease
Insulin Signaling in Skeletal Muscle

The insulin sensitizing effects of metformin and pioglitazone in the skeletal muscle remain unknown. Our group aims to analyze molecular changes within the skeletal muscle of pre-diabetic patients through the use of a clinical trial in humans.


Eligibility Criteria:
Inclusion Criteria:

* Pre-diabetes as defined by an oral glucose tolerance test 2-hour level between 140 and 200 mg/dL

General Inclusion Criteria:

* Able to communicate meaningfully with the investigator and legally competent to provide informed written consent.
* Female subjects must be non-lactating, have a negative pregnancy test, and be on acceptable birth control.

Exclusion Criteria:

* Oral glucose tolerance test \<140 or \>200mg/dL
* Treated with any of the following medications:

  * Systemic glucocorticoids (more than 2 weeks), antineoplastic agents, transplant medications, fibrates, anti-retroviral medications, or thiazolidinediones within 6 months prior to screening
  * Start or change of hormonal replacement therapy within 3 months prior to screening
  * Short-acting insulin (more than15 units per day) in DMT2 subjects, indicating severe insulin deficiency within 6 months prior to screening
* History or presence of any of the following conditions:

  * Clinically significant heart disease (New York Heart Classification greater than grade II; more than non-specific ST-T wave changes on the EKG)
  * Peripheral vascular disease (history of claudication)
  * Clinically significant pulmonary disease.
  * Current uncontrolled hypertension (systolic BP\>160 mmHg, diastolic BP\>100 mmHg)
  * History or presence of malignancy other than basal cell or squamous cell skin cancer
  * Autonomic neuropathy
  * Clinically significant hematologic disease
* Any of the following abnormal laboratory values:

  * Hematocrit \< 35 vol%
  * Serum creatinine \> 1.6 mg/dl
  * AST, ALT or Alkaline phosphatase \> 2.5 times the upper limit of normal
  * PT, PTT outside the normal reference range
  * TSH outside the normal reference range
  * Triglycerides \> 400 mg/dl
  * Platelet count \< 50,000
* Current or history of drug abuse or alcohol abuse
* Blood donation within 2 months prior to screening
* Engage in exercise with moderate to hard intensity for greater than 1 hour per day for 5 or more days per week.
* Diagnosed with Type 1 diabetes
Assessment of Central Sensitization, Neuropathic Pain, Sleep Quality and Daily Life Activities in Behcet's Disease

There are few studies in the literature regarding increased frequency of neuropathic pain and sleep disturbance and decreased quality of life in Behçet's disease. Frequency of central sensitization was not investigated in patients with Behçet's disease before. In this study, it is aimed to investigate the frequency of central sensitization, neuropathic pain, sleep disorder and quality of life and their relation to each other in Behcet's disease.

Central sensitization reduces the pain threshold in the pain pathways of the nervous system, causing pain sensation to be perceived with lower stimuli and often causing chronic pain. Central sensitization can be seen with many conditions such as neuropathic pain and sleep disorders, as well as with inflammatory diseases such as rheumatoid arthritis. There are few studies in the literature regarding increased frequency of neuropathic pain and sleep disturbance and decreased quality of life in Behçet's disease. Frequency of central sensitization was not investigated in patients with Behçet's disease before. In this study, it is aimed to investigate the frequency of central sensitization, neuropathic pain, sleep disorder and quality of life and their relation to each other in patients with Behcet's disease and healthy controls.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with Behcet disease according to international study group criteria
* Healthy volunteers without previously known systemic chronic disease
* Patients older than 18
* Patients younger than 75

Exclusion Criteria:

* Participants which were previously diagnosed with diabetes mellitus
* Participants which were previously diagnosed with chronic renal failure
* Pregnant women
Establishing Clinical Significance in Rotator Cuff Disease

The goal of this observational study is to learn about rotator cuff patients. The main questions it aims to answer are:

* What is the minimal clinically important difference value of the Shoulder Disability Questionnaire, the short version of the Western Ontario Rotator Cuff Index, the Shoulder Rating Questionnaire, and the University of California-Los Angeles Shoulder Scale?
* What is the substantial clinical benefit value of the Shoulder Disability Questionnaire, the short version of the Western Ontario Rotator Cuff Index, the Shoulder Rating Questionnaire, and the University of California-Los Angeles Shoulder Scale?
* What is the patient-acceptable symptomatic state value of the Shoulder Disability Questionnaire, the short version of the Western Ontario Rotator Cuff Index, the Shoulder Rating Questionnaire, and the University of California-Los Angeles Shoulder Scale?
* What is the maximal outcome improvement value of the Shoulder Disability Questionnaire, the short version of the Western Ontario Rotator Cuff Index, the Shoulder Rating Questionnaire, and the University of California-Los Angeles Shoulder Scale?
* What are the risk factors that prevent rotator cuff patients from reaching the minimal clinically important difference value?
* What are the risk factors that prevent rotator cuff patients from reaching the substantial clinical benefit value?
* What are the risk factors that prevent rotator cuff patients from reaching the patient-acceptable symptomatic state value?
* What are the risk factors that prevent rotator cuff patients from reaching the maximal outcome improvement value?


Eligibility Criteria:
Inclusion Criteria:

* to be over 18 years old
* to be a rotator cuff patient

Exclusion Criteria:

* to have another pathology in the affected shoulder area
* to have a neurological, rheumatological, or oncological disease
* to have radiculopathy
* to have had a previous fracture or operation in the affected shoulder area
* to be not cooperative enough for what will be done within the scope of the study
Accuracy of Non-Invasive Blood Pressure Measurement in Adults

The purpose of this study is to compare the accuracy of the Sotera ViSi, an investigational device, to auscultation (measurement with a cuff) in determining systolic and diastolic blood pressure (BP) in adult subjects.

This study is a single-center blinded study that will enroll approximately 150 adult subjects. Trained auscultators will perform the standard auscultation BP measurements. They will be blinded to each other's measurements and from the ViSi measurements.

The study population will be randomized into two groups based on the side of the blood pressure measurement: the left arm group (LAG) and the right arm group (RAG).

The randomization ratio of the LAG and RAG will be 1:1. There will be forced stratification in order to ensure that the study subjects meet the required arm circumference and blood pressure distributions as specified in the SP10:2008 and ISO 81060-2:2009(E) standards.

Eligibility Criteria:
Inclusion Criteria:

* Subject is greater than 12 years of age at the time of screening.
* Subject's upper arm circumference is between 20cm and 55cm.
* Subject is willing to undergo the Informed Consent process prior to enrollment in the study.
* Subject is willing and able to participate for up to 60 minutes.

Exclusion Criteria:

* Subject is participating in another clinical study that may interfere with the results of this study.
* Subject is unable to have a blood pressure measurement taken from either arm for any reason.
* Subject is evaluated by the Investigator and found to be medically unsuitable for participation in this study.
A Trial Investigating the Possible Difference in Development of Type 2 Diabetes Between Caucasian and Japanese Subjects

This trial is conducted in Europe and Japan. The aim of this clinical trial is to investigate the possible difference in the development of type 2 diabetes in a Japanese and a Caucasian population. Healthy subjects, subjects with impaired glucose tolerance, as well as subjects with type 2 diabetes will be included in the trial. The development of type 2 diabetes across the cohort will be investigated with regard to insulin sensitivity and B-cell capacity.


Eligibility Criteria:
Inclusion Criteria:

* Danish (Northern European) or Japanese (according to country allocation) background for at least 3 generations
* BMI above or equal to 18 kg/m2

Exclusion Criteria:

* Treatment of diabetes mellitus with any insulin product
* Fasting plasma/serum glucose above 12 mM
* Therapy with TZD (thiazolidinedione) drugs within the past 3 months
* Therapy with more than 2 OADs (oral anti-diabetics drugs)
Epidemiology of Pecan Nut Allergy

IgE-mediated food allergy can manifest with reactions ranging from hives to anaphylactic shock. The diagnosis is based on the confirmation of sensitization to the food allergen by skin tests (prick) and the determination of specific IgE directed against the food source and molecular allergens. The gold standard remains the oral provocation test, which is performed in a hospital environment. Once the diagnosis is made, an elimination diet is still considered as the cornerstone of treatment for most food allergies.

While some allergies, such as cow's milk or egg, tend to resolve spontaneously, others, such as allergy to pecan nuts, show a tendency to be persistent. In addition, pecan allergy is often characterized by potentially serious clinical reactions, compared to other foods, which can even be life threatening. In our clinical practice, the investigators found that patients with allergies to pecan nuts often present with severe hypersensitivity reactions when challenged orally to this food. Beyond this information, there are few studies regarding pecans. The investigators decided to retrospectively evaluate the results of oral food challenge and of the allergy work-up in our patients sensitized and allergic to pecan nuts, to better understand the current epidemiology of such food allergy.


Eligibility Criteria:
Inclusion criteria:

* Patients assessed for pecan allergy, through oral food challenge, from January 2000 to december 2021, at the University Hospital of Montpellier
* Patients with a positive skin prick test and/or positive specific IgE to pecan nut

Exclusion criteria:

* Patients not affiliated to French Social Security
* Patients not capable of understanding French
* Patients sensitized to pecan nut, who did not perform an oral food challenge to this food allergen
Efficacy of Telepsychiatry in the Treatment of Depression

Telepsychiatry is a novel means of providing expert psychiatric treatment to patients who live far from a source of care. If it can be demonstrated that treatment via telepsychiatry is as effective as in-person treatment, then many individuals with psychiatric illness will have easy access to psychiatric care, even if they live in geographically remote areas.

Background:

Telepsychiatry is a novel means of providing expert psychiatric treatment to patients who live far from a source of care. If it can be demonstrated that treatment via telepsychiatry is as effective as in-person treatment, then many individuals with psychiatric illness will have easy access to psychiatric care, even if they live in geographically remote areas.

Objectives:

The major goal of this study was to determine whether treatment of depressive disorders via telepsychiatry is as effective as in-person treatment. In addition, this study was designed to determine if depressed patients are as compliant and as satisfied with telepsychiatry as with in-person treatment. Another goal was to compare the cost and cost-effectiveness of remote treatment via telepsychiatry to in-person treatment.

Methods:

In this randomized controlled trial, veterans who presented with depression to any of three VA Maryland Health Care facilities with a SCID-IV depression diagnosis and a Hamilton Rating Scale for Depression (Ham-D) score of 16 or above were eligible for participation. Eligible veterans were randomized to either "in-person" treatment or "remote" treatment. Treatment occurred over six months and consisted of psychotropic medication and psycho-education concerning the disease, medications, and side effects. The major outcome variables included changes in Ham-D depression ratings and Beck Depression Inventory (BDI) self-reported depression ratings.

Status:

Completed.

Eligibility Criteria:
Inclusion Criteria:

Depression, Hamilton 16 or above, SCID-IV depression diagnosis

Exclusion Criteria:
Ivonescimab in Combination With Docetaxel in Advanced Non-Small Cell Lung Cancer

This is a Phase 3 Randomized, double-blind, Multicenter Study of Ivonescimab Combined with Docetaxel Versus Placebo Combined with Docetaxel in Patients with Locally advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) that has progressed on or after PD-(L)1 inhibitor-based therapy. The purpose of this study is to evaluate the efficacy and safety of ivonescimab versus placebo, combined with docetaxel in patients with advanced NSCLC.


Eligibility Criteria:
Inclusion Criteria:

* Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures).
* Age ≥ 18 years old and ≤ 75 years old at the time of randomization.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Expected life expectancy of at least 3 months.
* Histologically or cytologically confirmed diagnosis of NSCLC.
* Locally advanced or metastatic NSCLC (American Joint Committee on Cancer \[AJCC\] 8th edition).
* Previously received systemic platinum-based chemotherapy and PD-1/L1 inhibitors.
* At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
* Adequate organ function.

Exclusion Criteria:

* Histologic or cytopathologic evidence of the presence of small cell lung carcinoma.
* Other malignancies within 3 years prior to randomization.
* Known actionable genomic alterations.
* Prior administration of any immunotherapy targeting immune mechanisms other than PD-1/PD-L1 inhibitors.
* Previous treatment with docetaxel.
* History of severe bleeding tendency or coagulation dysfunction.
* Active autoimmune disease requiring systemic therapy within 2 years prior to randomization.
* History of myocarditis, cardiomyopathy, and malignant arrhythmia.
Butyrate/Hexanoate in Metabolic Health

In this study, we aim to identify a well consumable butyrate/hexanoate-enriched oil that increases circulating SCFA concentrations and improves postprandial substrate metabolism, which could be further used for a long-term study.


Eligibility Criteria:
Inclusion criteria

* Overweight/obese men (BMI ≥ 25 kg/m2 and ≤ 34.9 kg/m2);
* Aged 40 - 70 years;
* Caucasian;
* Normal blood pressure (systolic blood pressure 100-140mmHg, diastolic blood pressure 60-90 mmHg);
* Weight stable for at least 3 months (± 2 kg).

Exclusion criteria

* Type 2 diabetes mellitus (defined as fasting plasma glucose ≥ 7.1 mmol/L)
* Gastroenterological diseases or abdominal surgery (gallbladder removal and appendix removal are allowed)
* Cardiovascular diseases, cancer, liver or kidney malfunction, disease with a life expectancy shorter than 5 years;
* Lactose intolerance or other disorders that affect digestion (such as celiac disease)
* Abuse of products; alcohol and drugs, excessive nicotine use defined as \>20 cigarettes per day; and excessive alcohol use defined as (\> 15 units/week)
* Plans to lose weight or following of a hypocaloric diet in the following three months;
* Regular supplementation of pre- or probiotic products (for example Yakult, Activia), use of pre- or probiotics 3 months prior to the start of the study;
* Intensive exercise training more than three hours a week;
* Use of any medication that influences glucose or fat metabolism and inflammation (i.e. betablockers, corticosteroids, statins or NSAIDs);
* Regular use of laxation products in 3 months prior start of study or during study period;
* Use of antibiotics in the last three months (antibiotics use can alter substantially the gut microbiota composition).
* Follow a vegan diet or vegetarian diet.
Injury Incidence in Professional Soccer

The winter break within the German Professional Football Leagues will be shortened as for the season 2009/2010 from 6.5 to 3.5 weeks. That might have repercussions on injury incidence in either way, positive or negative. On the one hand, recovery time during the winter will be shorter, which might lead to an increased risk of injury. On the other hand, it will allow a better spread of games in the second round, thus reducing the amount of the so-called "English weeks", which in turn could reduce the number of injuries. This study compares injury incidence between the season 2008/2009 (long winter break) and the season 2009/2010(short winter break) via questionnaires in accordance with UEFA/FIFA injury evaluation criteria.


Eligibility Criteria:
Inclusion Criteria:

* German professional male soccer players

Exclusion Criteria:

* Loss of professional status as a soccer player
The Effect of Sensorial Biodex Balance Balance System Exercises in Diabetic Neuropathy

This study examined the effects of balance exercises performed with the Biodex Balance System (BBS) on nerve conduction, sensory symptoms, and muscle strength in patients with diabetes-related neuropathy.

We enrolled twenty-seven patients in this study. Patients in the intervention group (n=14) performed exercises using the computerized BBS. The control group (n=13) was just informed about diabetes self-management. All patients underwent pretest and posttest peripheral nerve conduction studies. Sensory examination performed by using 5.07 Semmes-Weinstein monofilaments and 128-Hz tuning fork. Muscle strength measurements obtained with manual dynamometer

Eligibility Criteria:
Inclusion Criteria:

* diabetes-related neuropathy based on laboratory tests, clinical findings, and nerve conduction study

Exclusion Criteria:

* increased risk of non-diabetes related neuropathy: history of autoimmune, cerebrovascular, or chronic infectious disease, cancer, chemotherapy and/or radiotherapy, radicular neuropathy, chronic kidney and liver failure, alcoholism or other substance abuse, and mental or physical disabilities (including blindness). We also excluded patients who didn't speak Turkish
A Prospective Trial of Behavioral Therapy for Chronic Cough

This study seeks to explore whether heart rate variability (HRV) biofeedback can be effective in the treatment of chronic cough. Chronic cough has many causes, including asthma, postnasal drip, and gastroesophageal reflux disease (GERD), each with a specific treatment. However, among a subset of cough patients, no clear cause is found despite extensive workup, and traditional treatment methods do not provide relief. Several studies revealed less common causes of chronic cough and disordered breathing such as vagal neuropathy, paradoxical vocal fold motion, and stress. Additional research identified links between the neurological networks that produce the cough reflex and those that maintain normal breathing. HRV biofeedback is a self-regulation technique that uses computer equipment to monitor heart rate and breathing, two key functions of the autonomic nervous system. By using this non-invasive behavioral technique, cough patients can regulate their breathing and autonomic function, potentially leading to improved autonomic balance and a reduction in cough symptoms.


Eligibility Criteria:
Inclusion Criteria:

* 8+ weeks of cough, Fluent English speaker, Have access to an electronic mobile device

Exclusion Criteria:

* On neuromodulator therapy, cardiac arrhythmia, dysphagia, prior HRVB or mindfulness, head and neck surgery of the oropharynx, neck or larynx, lung surgery, pulmonary pathology other than asthma, tourette syndrome, ACE inhibitor use, current or recent smoker.

Added exclusion criteria as of March 2020 - history of COVID+.