cyrilzakka/clinical-trials huggingface dataset:
The Mixed Phenotype of Asthma and COPD: the Overlap Syndrome

RATIONALE:

In asthmatic subjects, smoking can lead to several changes in disease characterictics. in smokers of more than 20 pack-years, chronic obstructive pulmonary disease (COPD) can be associated with asthma, also called asthma-COPD overlap syndrome (ACOS). Increasing data support the concept that ACOS is a clinical entity. However, this should be further studied in order to better target therapy.

AIM:

The objective of this study is to evaluate the comparative features of ACOS

METHODS:

This will be a descriptive study comparing the features of the ACOS with the features of asthmatic subjects with an incomplete reversibility of airway obstruction (IRAO).The study will be done over 1 or 2 visits (within a week interval), according to subjects' availability. The visit will include completion of different questionnaires (asthma control asthma quality of life, medical history, exacerbations, etc.), a thoracic examination, allergy skin-prick tests, spirometry and bronchodilator response, lung volumes and compliance measurements, exhaled nitric oxide measurement, blood sampling and a sputum induction.


Eligibility Criteria:
Inclusion Criteria:

ALL SUBJECTS

1. Subjects aged 45 years and older.
2. Free of any other respiratory condition, except for asthma and/or COPD, which may interfere with the tests.
3. Asthma that requires a baseline treatment with inhaled corticosteroids and/or additional asthma medication.
4. Free of respiratory infection in the 4 weeks preceding the study.
5. No changes in the asthma and COPD-related medications in the 4 weeks preceding the study.
6. If female, not pregnant (or lactating).
7. Able to adhere to study procedures.
8. Able and willing to provide written informed consent to participate in the study, in accordance with international conference on harmonization (ICH) good clinical practice (GCP) requirements.

ACOS SUBJECTS

1. Smokers or ex-smokers of at least 20 pack-years. 2. With an IRAO (see definitions section). IRAO SUBJECTS

1. Long-life non-smokers or ex-smokers defined as someone who smoked less than 5 pack-years and who completely stopped smoking for at least 12 months before inclusion in the study.
2. With an IRAO.

Exclusion Criteria:

* ALL SUBJECTS

  1. With COPD without a past diagnosis of asthma.
  2. Unstable respiratory or non-respiratory condition.
  3. Any active chronic inflammatory disease.
  4. Any evidence of malignancy (active and/or treated) within the previous 5 years.
  5. Any significant concomitant illness or injury that would interfere with the subject's participation in the study.
  6. Any history of bronchial thermoplasty. IRAO SUBJECTS

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  1. Use of any nicotine containing product within 1 year prior to study entry or a smoking history of \> 5 pack-years.
Tranexamic Acid in Reducing Blood Loss in Patients With Pelvic Tumors Undergoing Hemipelvectomy Surgery

This early phase I trial studies how well tranexamic acid works in reducing the loss of blood in patients with pelvic tumors undergoing hemipelvectomy surgery. Tranexamic acid decreases blood loss by stabilizing clots and preventing clot lysis in patients undergoing surgery.

PRIMARY OBJECTIVES:

I. To determine if the use of tranexamic acid results in a significant reduction in intraoperative and perioperative blood loss.

SECONDARY OBJECTIVES:

I. To determine if use of tranexamic acid lowers the amount of blood products transfused in hemipelvectomy surgeries and during first postoperative week.

II. To determine if the use of tranexamic acid has an effect on laboratory (lab) measurements preoperatively through postoperative day 7.

III. To determine if use of tranexamic acid has an effect on complication, length of intensive care unit (ICU), and hospital stays.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I (TRANEXAMIC ACID): Patients receive tranexamic acid intravenously (IV) over 15 minutes 30 minutes prior to surgery and continuously during hemipelvectomy procedure in the absence of disease progression or unacceptable toxicity.

ARM II (NO TRANEXAMIC ACID): Patients undergo standard of care hemipelvectomy in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 7 days.

Eligibility Criteria:
Inclusion Criteria:

* Both pediatric and adult patients can be eligible to participate
* Cognitively impaired and non-English speakers can be eligible to participate.
* Both male and female patients must have a pelvic tumor and are scheduled to have surgery at University of Texas (UT) Monroe Dunaway (MD) Anderson Cancer center that require hemipelvectomy, resulting in pelvic ring disruption

Exclusion Criteria:

* Patient with a history of genetic prothrombotic state
* Patient with a history of thromboembolic disease to include pulmonary embolus or other extremity deep venous thrombosis
* Patients with thrombosis of the planned site of resection will not be excluded if the thrombus is caused directly by tumor burden or outflow obstruction
* Female patients will not be eligible for this study if she is either pregnant or nursing at the time of enrollment
* Patients will not be eligible if they have a history of color vision defects
* Patients will not be eligible if they have a history of retinal vein or artery occlusion
* Patients will not be eligible if they have a history of intracranial hemorrhage in past 6 months
* Patients will not be eligible if they have a history of hypersensitivity to tranexamic acid
* Patients will not be eligible if they present with moderate to severe decrease in creatinine clearance (estimated glomerular filtration rate \[eGFR\] \< 45 mL/min/1.73m2)
* Patients will not be eligible if they present or have a history of seizure disorder
Turkish Version of The Diabetes Quality of Life Brief Clinical Inventory Validity and Reliability

This study aims to develop Turkish version of the Diabetes Quality of Life Brief Clinical Inventory (DQL-BCI) and to perform validity and reliability evaluations.

The study will be carried out in two phases: DQL-BCI will be translated into Turkish and adapted to the cultural context, and the reliability and validity of the Turkish version of DQL-BCI will be investigated. The translation process will be performed in accordance with generally accepted international principles of translation and cultural adaptation of measurement tools. At least 150 subjects with type 2 diabetes will complete the Turkish version of DQL-BCI, the EQ-5D-3L questionnaire and the SF-12 quality of life questionnaire. The examination will provide information about the reliability and the construct validity of the studied tool.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18-65 years old
* Diagnosed with diabetes for one year or more (Type 1 or Type 2)
* Literacy
* Being on at least one anti-diabetes medication

Exclusion Criteria:

* Not willing to participate in the study
The Effect of Emotional Freedom Techniques (EFT) in Smokers Failing a Smoking Cessation Program

The National Health Service (NHS) stop smoking service at the Central Lancashire NHS Trust serves a diverse population of smokers, with a very good quit rate and high standards. However, clinical experience predicts that some clients are unlikely to succeed through the NHS smoking cessation program. This special population has difficulty quitting for a variety of reasons. Some relapse over the course of the following two years and return repeatedly to the service. Others, for instance those with health problems, may be highly motivated to quit, but unable to resist their cravings. The purpose of this study is to determine if EFT makes a difference in quit rates with the most challenging population of clients.


Eligibility Criteria:
Inclusion Criteria:

* High anxiety related to the quit attempt
* Cravings which sabotage the quit attempt
* Low confidence at their ability to quit and remain quit

Exclusion Criteria:

* None, all NHS clients are eligible
The Association Between IL17, Acute Respiratory Distress Syndrome and Acute Respiratory Failure

This study will look at a protein called Interleukin (IL)-17A and how it relates to health markers in patients with a serious lung condition known as Acute Respiratory Distress Syndrome (ARDS). IL-17A is part of the immune system and helps the body fight infections, but too much of it can lead to inflammation, which can be harmful.

The researchers want to find out if the levels of IL-17A in the blood are connected to important health outcomes for patients, such as whether they survive in the Intensive Care Unit (ICU), after 30 days, and after 60 days. They will also check how long patients can stay off a ventilator and how many days they need to use a mechanical ventilator. A ventilator is a machine that helps people breathe when their lungs are not working well.

In addition to the main goal, the researchers will study how IL-17A relates to a severe form of ARDS called the hyperinflammatory sub-phenotype. They will also look at how IL-17A connects with other health markers, including IL-6, soluble tumor necrosis factor receptor (sTNFR), IL8, Tumor Necrosis Factor (TNF)a, IL1beta, and IL23. These markers can give information about inflammation and how the body is responding to illness.

To compare results, the researchers will include a control group of patients who had Acute Respiratory Failure (ARF) but did not have ARDS. This control group will help them understand the differences between the two conditions.

This research will use data from the FROG-ICU Registry, which gathers information on patients in intensive care units across Europe. The registry tracks patients' health after they leave the ICU, focusing on the risk factors for death in the year following their discharge. The data comes from 28 different ICUs in 19 hospitals.

The researchers will create two groups of patients based on their diagnoses: one group with ARDS and another with ARF. By studying these groups, they hope to learn more about the role of IL-17A in ARDS and its potential impact on patient outcomes.


Eligibility Criteria:
Inclusion Criteria:

* invasive mechanical ventilation support for at least 24 h and/or treatment with a positive inotropic agent (except dopamine) for more than 24 h
* ARDS patients:

  o Diagnosis of ARDS at the time of study inclusion and within 24-48 hours of bio sample collection
* ARF patients o Diagnosis of Acute respiratory Failure (ARF) who do not have sepsis at the time of study inclusion and within 24-48 hours of bio sample collection

Exclusion Criteria:

o Patients with ARF who later develop ARDS after the 24-48 hour bio sample draw time period will be excluded as they will not have had baseline bio samples drawn in relation to onset of ARDS.

* Patients less than 18 years old
* severe head injury (initial Glasgow Coma Scale \< 8) or brain death or a persistent vegetative state
* pregnancy or breastfeeding
* transplantation in the past 12 months; not expected to survive or to leave the hospital
* no social security coverage
Variability in Adrenergic Response

The goal of this project is to determine the genetic factors contributing to interindividual differences in response to physiological and pharmacological vasoconstrictors and vasodilators.

The dorsal hand vein model is a relatively non-invasive and robust experimental model to examine the local in vivo effect of vasoactive drugs without elucidating systemic counterregulatory reflexes. Infusion of incremental low doses of phenylephrine into a dorsal hand vein results in increasing local venoconstriction, without systemic effects. Similarly, infusion of incremental low doses of nitroglycerin into a preconstricted dorsal hand vein results in increasing local venodilation, without systemic effects. Systemic vascular responses can be measured by the cold pressor test (CPT),that leads to increase in blood pressure and heart rate , or mental stress that is also known to stimulate cardiovascular responses. Individuals vary in their local and systemic vascular responses but the genetic determinants of these are not clear.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 40 years, inclusive.
* Subject must be willing to give written informed consent and be able to adhere to diet and study schedules.
* Subjects must be free of any clinically significant disease that requires a physician's care and/or would interfere with the study evaluations.
* Subjects must have a normal or clinically acceptable physical examination and ECG.
* Clinical laboratory tests (CBC, blood chemistries, and urinalysis) must be within normal limits or clinically acceptable to the investigator.

Exclusion Criteria:

* Any subject who has taken any prescription or over-the-counter drugs, other than oral contraception if female, within two weeks prior to study drug administration.
* Subjects who are presently, or were formerly, narcotic addicts or alcoholics.
* Subjects who have a clinically significant allergy/intolerance to phenylephrine.
* Females with a positive serum/urine pregnancy test at screening.
* Females who are nursing.
* Subject using sildenafil or other phosphodiesterase inhibitors.
A Bidirectional Study in Exploring the Dynamic Changes of Plasma and Urine Metabolites of Head and Neck Cancer

Dynamic changes in the internal environment of the body are important clues for early detection, diagnosis and even cure of head and neck tumors. This project uses the combination of proteomics technology and liquid biopsy to provide more primary prevention strategies for early intervention, secondary prevention strategies for early detection and treatment, and clues for the study of the mechanism of dynamic evolution of head and neck tumors.

Head and neck cancer is the seventh most common malignant tumor in the world, and China is a country with a high incidence of head and neck cancer. Dynamic changes in the internal environment of the body are important clues for early detection, diagnosis and even cure of head and neck tumors. The occurrence and development of head and neck cancer is complex, so it is particularly important to explore the changes of internal environment in its clinical pathway. Therefore, we conducted this study to investigate the changes of plasma and urine metabolites during the development of head and neck cancer.

(1) Retrospective cohort: 250 patients were recruited, including 125 patients with Head and neck cancer and 125 healthy people.,(2) Prospective cohort: 250 patients were recruited, including 125 head and neck cancer patients and 125 healthy people. During the course of the study, the subjects will not be given or provided with any randomized or any treatment driven by the study protocol. If it is clinically applicable, the treatment physician shall make the treatment decision and choose the treatment plan at his discretion.

Eligibility Criteria:
Inclusion Criteria:

1. Head and neck cancer patients

   * Age 18-75 years old;
   * Male or non-pregnant female;
   * Patients who were normatively diagnosed as head and neck tumors according to the WHO standards of 2017;
   * The general situation is good: KPS score ≥70;
   * No other malignant tumors.
2. Healthy people

   * Age 18-75 years old;
   * Male or non-pregnant female;
   * No history of head and neck related diseases or other diseases known to affect blood lipid/protein metabolism.

Exclusion Criteria:

* Previous history of non-research related head and neck conditions or other known effects on blood metabolism (except for controlled type 2 diabetes);
* With a history of other malignancies (except cell carcinoma and cervical carcinoma in situ);
* Diseases that require long-term use of immunosuppressive drugs (including steroids), including but not limited to congenital or acquired immunodeficiency disorders or active central nervous system rotations, metastatic cancer, active infection, or uncontrolled heart disease;
* Concurrent with other uncontrolled serious medical conditions, such as unstable heart disease that requires treatment Disease, poorly controlled diabetes (fasting blood glucose \> 1.5× the upper limit of normal), mental illness and a history of severe allergies.
* BMI less than 18 or greater than 25.
Transverse B-Lynch in Management of Placenta Accreta

Placenta accreta is considered a severe pregnancy complication that may be associated with massive and potentially life-threatening intrapartum and postpartum hemorrhage. Life-threatening bleeding is the most common complication to be associated with this condition; the average blood loss at time of delivery is reported to be 3000-5500 mL, which leads to significant postoperative morbidity and death.


Eligibility Criteria:
Inclusion Criteria:

1. All pregnant women with placenta previa as diagnosed by ultrasound with suspicion of abnormal placentation by Doppler us, confirmed intraoperatively undergoing either emergent or elective cesarean

Exclusion Criteria:

1. Patients who will be managed by hysterectomy
2. Patients who will be managed by conservative leaving the placenta in-situ
Multidisciplinary Diagnosis and Treatment of Polycystic Ovary Syndrome

The investigators collected clinical data and serum samples of patients with polycystic ovary syndrome (PCOS) in this study, used statistical software such as SPSS for date analysis, and used experimental techniques such as ELISA and flow cytometry to detect serum samples, aiming to explore the relationship between the body anthropometry, skin conditions, psychosomatic status, diet, sleep, exercise, glucose and lipid metabolism, gonadal hormones, and body fat distribution in patients with polycystic ovary syndrome, and to discovery new biomarkers. Multidisciplinary exploration of the mechanisms of disease occurrence and development, the establishment of a PCOS multicenter, multidisciplinary and multidimensional clinical research database, combined with the established statistical analysis strategy for big data and analysis, to promote the realization of more accurate personalized medicine.


Eligibility Criteria:
Inclusion Criteria:

* Female aged 18- 45;

Exclusion Criteria:

* Female patients younger than 18 years old or older than 45 years old;
* Ovulatory disorders caused by premature ovarian failure, pituitary amenorrhea, hypothalamic amenorrhea, and thyroid dysfunction;
* Congenital adrenal hyperplasia, reservoir Hin syndrome, hyperprolactinemia, adrenal tumors and other diseases that cause hyperandrogenism;
* Abnormal liver or renal function((≥ 3 times of the upper limit of normal range)
* Type 1 diabetes, single gene mutation diabetes, or pancreatic damage Diabetes or other secondary diabetes caused by diabetes;
* History of malignant tumors;
* Severe infection, severe anemia, neutropenia and other systemic chronic diseases;
* Undergo total hysterectomy or ovarian adnexectomy;
* Mental illness, dementia or other cognitive behavioral problems;
* Use hypoglycemic drugs that may affect insulin resistance and androgen levels in the last 3 months, including thiazolidinediones, metformin, SGLT-2, and acarbose and GLP-1RA and other drugs;
* Use letrozole, clomiphene, oral contraceptives, glucocorticoids, gonadotropins, gonadotropin-releasing hormone agonists, anti-androgens (spironolactone, Cyproterone acetate, flutamide, etc.) and other drugs for the treatment of PCOS.
Interaction Study of Clopidogrel 600/150 mg Given Alone or Concomitantly With Omeprazole 80 mg in Healthy Subjects

Primary objective:

* Assess the effects of clopidogrel (600 mg loading dose followed by 4 days 150 mg/day) on Adenosine diphosphate (ADP)-induced platelet aggregation when given concomitantly with omeprazole 80 mg/day compared to given alone in healthy male and female subjects

Secondary Objective:

* Compare the pharmacokinetic profiles of clopidogrel and its active metabolite when clopidogrel is given either alone or concomitantly with omeprazole

The total study duration per subjects is 8 - 9 weeks broken down as follows:

* Screening: 2 to 21 days before the first dosing (clopidogrel or omeprazole)
* Period clopidogrel/placebo: 7 days including 5 days treatment
* Period clopidogrel/placebo + omeprazole: 12 days including 10 days treatment
* Washout between periods: at least 14 days after last dosing with respect to clopidogrel treatment
* End of study: 7 to 10 days after the last dosing

Eligibility Criteria:
Inclusion Criteria:

Healthy subject:

* as determined by medical history, physical examination including vital signs and clinical laboratory tests:
* with a body weight between 50 kg and 95 kg if male, between 40 kg and 85 kg if female, and with a Body Mass Index (BMI) between 18 and 30 kg/m²

Exclusion Criteria:

* Evidence of inherited disorder of coagulation/hemostasis functions
* Smoking more than 5 cigarettes or equivalent per day
* Abnormal hemostasis screen
* Unability to abstain from intake of any drug affecting hemostasis throughout the whole study duration \>Any contraindication to clopidogrel and/or omeprazole

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Dry Needling Versus Conventional Physical Therapy in Patients With Knee Osteoarthritis

The purpose of this research is to compare the effectiveness of conventional physical therapy (manual physical therapy, exercise, range of motion, and stretching) versus conventional physical therapy combined with dry needling in patients with knee osteoarthritis (OA). Physical therapists commonly use conventional physical therapy techniques and dry needling to treat knee OA, and this study is attempting to find out if the addition of dry needling to conventional physical therapy has an equal, greater, or lesser effect than conventional physical therapy alone.

Patients with knee OA will be randomized to receive 1-2 treatments per week for 6 weeks (up to 10 sessions total) of either: (1) Dry Needling and conventional physical therapy or the (2) Conventional physical therapy (manual physical therapy, exercise, range of motion and stretching)

Eligibility Criteria:
Inclusion Criteria:

1. Report of knee pain of at least 2/10 per NPRS (0---10 scale) for \>3 months
2. Report of at least 3 of the following per Altman et al. (1986)

   * Over 50 Years of age
   * Less than 30 minutes of morning stiffness
   * Crepitus on active motion
   * Bony tenderness
   * Bony enlargement
   * No palpable warmth of synovium

Exclusion Criteria:

1. Report of red flags to manual physical therapy to include: hypertension, infection, diabetes, peripheral neuropathy, heart disease, stroke, chronic ischemia, edema, severe varicosities, tumor, metabolic disease, prolonged steroid use, fracture, RA, osteoporosis, severe vascular disease, malignancy, etc.
2. History of previous surgery to the knee
3. History of physical therapy, massage therapy, chiropractic treatment, or injections for knee pain in the last 4 weeks
4. History of a surgical procedure on either lower extremity in last 6 months
5. Two or more positive neurologic signs consistent with nerve root compression, including any two of the following:

   * Weakness involving a major muscle group of the lower extremity.
   * Diminished patella or achilles tendon reflex
   * Diminished or absent sensation to pinprick in lower extremity dermatome
6. Involvement in litigation or worker's compensation regarding knee pain.
7. Any condition that might contraindicate the use of electro-needling
8. The patient is pregnant.