cyrilzakka/clinical-trials huggingface dataset:
Immediate Effect of Cervical and Sacroiliac Manipulation on the Autonomic Nervous System and Balance

The aim of this study is to investigate the immediate effects of high-velocity low-amplitude (HVLA) chiropractic manipulation on the autonomic nervous system and baropodometric parameters. The effects of different manipulation techniques on pedobarographic analysis and the autonomic nervous system were examined.

Ninety-six individuals who met the inclusion criteria participated in the study. The participants were divided into three groups: the sacroiliac joint manipulation group (n=32), the cervical manipulation group (n=32), and the control group (n=30). No treatment was administered to the control group, while sacroiliac joint manipulation and cervical manipulation were applied to the sacroiliac joint manipulation group and the cervical manipulation group, respectively. Autonomic nervous system activity was assessed using the Polar H-10 device, pedobarographic analysis was performed using the METISENS pedobarographic evaluation device, and blood pressure and pulse were measured manually from the left arm using a sphygmomanometer. A 30-minute waiting period was used during the evaluation of the control group. A significance level of p\<0.05 was considered

Eligibility Criteria:
Inclusion Criteria:

* Willingness to participate voluntarily.
* Signed informed consent form.
* Age between 18 and 35 years.
* No contraindications for chiropractic practices.

Exclusion Criteria:

* History of orthopedic disabilities related to the lower extremity.
* Ankylosing spondylitis, rheumatoid arthritis.
* History of foot sprain/strain within the past six months.
* Presence of pathologies in the lumbar and sacroiliac regions (herniated discs, spondylosis, spondylolisthesis).
* History of cardiovascular and respiratory diseases.
* Psychiatric disorders such as psychosis and depression.
* Radicular root compressions causing progressive neurological deficits.
* Bleeding/coagulation disorders and receiving anticoagulant treatment.
* Acute fractures and orthopedic trauma.
* Spinal cord tumors and meningeal tumors.
* Intraosseous infections and acute inflammation, such as osteomyelitis.
* Cauda equina syndrome.
* Intracanicular hematomas.
* Spinal cord hematomas in the spine.
* Basilar invagination of the upper cervical region.
* Aneurysmal bone cysts, osteoid osteomas, osteolastomas, giant cell bone tumors.
* Post-surgical fixation prostheses.
* Neoplastic diseases in muscles or other tissues.
* Lhermitte's sign.
* Syringomyelia.
* Vertebral dislocations or hypermobile joints.
* Advanced osteoporosis.
* Vertebrobasilar insufficiency.

Criteria for Withdrawal from the Study:

* Pregnancy or suspicion of pregnancy.
* The volunteer's desire to discontinue participation in the study.
Nutritional Status and Barriers to Dietary Intake in Head and Neck Cancer Patients

The investigators hope to learn more about how side-effects of RT or RTchemo affect food intake and nutrition status.

Head and neck cancer patients often have difficulty meeting their nutritional needs while undergoing radiation therapy (RT) and/or chemotherapy (RTchemo). Tumor locations and side effects of RT or RTchemo, including dry mouth, mouth sores, difficulty chewing and swallowing, changes in taste and smell, and loss of appetite, lead to poor food intake and weight loss. The investigators hope to learn more about how side-effects of RT or RTchemo affect food intake and nutrition status.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Diagnosed with head and neck cancer including the lip, oral cavity, salivary glands, paranasal sinuses, oropharynx, nasopharynx, hypopharynx, larynx, and thyroid
* All histological types of cancer
* All tumour stages according to American Joint Committee for Cancer (AJCC) Staging
* All forms of RT including standard or investigational and/or concurrent standard or investigational chemotherapy for head and neck cancers
* Alert and mentally competent
* English speaking

Exclusion Criteria:

* Unwilling to participate
The Complement Lectin Pathway After Cardiac Arrest

This study includes comatose survivors of out-of-hospital cardiac arrest treated with 24 hours or 48 hours of targeted temperature management.

The overall aim is to evaluate the importance of plasma complement protein concentrations in patients resuscitated after out-of-hospital cardiac arrest and treated with 24 hours or 48 hours of targeted temperature management.

The specific aim is to evaluate:

* the concentration of plasma lectin pathway proteins the first, second and third day after cardiac arrest
* the relation between concentration of plasma lectin pathway proteins and mortality
* if prolonged targeted temperature management influences the concentration of plasma lectin pathway proteins

This study is a sub-study to the trial entitled: "Time-differentiated targeted temperature management (TTH48) (ClinicalTrials.gov Identifier: NCT01689077)"

The following Complement Lectin Pathway proteins will be measured: Mannan-Binding-Lectin, M-ficolin, H-ficolin, CL-L1, MASP-1, MASP-2, MASP-3, MAp19 and MAp44.


Eligibility Criteria:
Inclusion Criteria:

* Out-of-Hospital Cardiac Arrest of presumed cardiac cause
* Return of spontaneous circulation (ROSC)
* Glasgow Coma Score \< 8
* Age \> 18 years and \< 80 years

Exclusion Criteria:

* \> 60 minutes from the circulatory collapse to ROSC
* Time interval \> 4 hours from cardiac arrest to initiation of targeted temperature management
* Terminal illness
* Coagulation disorder
* Unwitnessed asystolia
* Cerebral performance category 3-4 before the cardiac arrest
* Severe persistent cardiogenic shock
* Pregnancy
* Persistent cardiogenic shock (systolic bloodpressure \< 80 despite inotropic treatment)
* New apoplexy or cerebral hemorrhage
* Lack of consent from the relatives
* Lack of consent from the general practitioner
* Lack of consent from the patient
Evaluating the Use of the Qidni/D Hemodialysis System by Subjects With End-Stage Renal Disease

The main goal of this clinical study is to evaluate the safety of the Qidni/D Hemodialysis System in patients with end-stage renal disease. The main question it aims to answer is:

Is the Qidni/D safe for performing hemodialysis?

Participants will be subjected to one treatment of hemodialysis for up to 4 hours with the use of the Qidni/D.


Eligibility Criteria:
Inclusion Criteria:

* Subject has provided informed consent.
* Subject is at least 18 years and less than 75 years of age.
* Subject has end-stage renal disease adequately treated by maintenance dialysis and has been deemed stable for at least three months by his/her treating nephrologist.
* Subject has a well-functioning and stable vascular access that allows a blood flow of at least 300 ml/min for conventional treatment or 200-250 mL/min for nocturnal hemodialysis treatment.
* Subject understands the nature of the procedures and the requirements of the study protocol.
* Subject is willing and able to comply with the protocol requirements and return to the treatment center for all required treatments and clinical evaluations.
* Subject has no childbearing potential or the Subject affirms they are not pregnant. Subject affirms using contraception measures to prevent potential pregnancies during the study period.

Exclusion Criteria:

* Subject is unable to read English.
* Subject has dementia or lacks capacity for self-care.
* Life expectancy less than 12 months from first study procedure.
* Subject unable to understand or cooperate with the hemodialysis nurse and dialysis care team.
* Subject has a documented history of non-adherence to dialysis therapy that would prevent successful completion of the study.
* Subject has had a recent major cardiovascular adverse event within the last 3 months.
* Subject has a persistent pre-dialysis sitting systolic blood pressure less than 100 mmHg despite medical therapy.
* Subject has ongoing, symptomatic intra-dialytic hypotension requiring medical intervention.
* Subject has an active infection requiring antibiotics within the last 7 days.
* Subject with fluid overload due to intractable ascites secondary to liver cirrhosis.
* Subject is seroreactive for Hepatitis B Surface Antigen.
* Subject has a history of adverse reactions to dialyzer membrane material.
* Subject is participating in another investigative drug or device clinical study related to dialysis which conflicts with the execution of this study.
* Subject is scheduled to receive an organ transplant during the course of the study: paired exchange or living donor.
* Subject has a life-threatening malignancy actively receiving treatment that would prevent successful completion of the study protocol.
* Any other documented condition that the Investigator feels would prevent the Subject from successful inclusion in the study.
* Subject has an active viral infection (eg. COVID-19).
* Subject is on peritoneal dialysis.
Breast Cancers: Risk Factors Among Mexican Women in Mexico, Mexican-American and African-American Women in the U.S.

The goal of this epidemiologic research study is to find out if various risk factors and certain markers (substances that help identify the presence of cancer) that help predict increased occurrence and prognosis (outcome of disease) of breast cancer differ among Mexican, Mexican-American, and African-American women.

An epidemiologic study looks at the patterns, causes, and control of disease in groups of people. Researchers want to see if various risk factors (such as decreased and delayed fertility, obesity, and a sedentary \[low physical activity\] lifestyle) and certain markers that cause breast cancer are different in women in the above groups.

If you have breast cancer and you agree to take part in this study, you will be interviewed by a trained interviewer with a questionnaire at a time convenient for you, either during your visit to MD Anderson or The Rose, or by phone. You will be asked questions about your personal demographics (such as your age and race), environmental exposures, medical history, family history of cancer, and other day-to-day lifestyle factors. It should take about 30-40 minutes to complete the interview. Clinical data about your breast cancer treatment will also be collected from your medical records.

You will also have a one-time blood draw (about 3 tablespoons). If blood cannot be drawn or not enough blood can be drawn, you will have a saliva sample taken where you will be required to spit into a container. If you have already donated blood or a saliva sample in the Mexican-American Cohort Study, a portion of that sample may be used instead of having to collect a new sample. Your blood or saliva sample will be used to look at your DNA (genetic material of cells). The study pathologist will look at possible prognostic markers (substances that predict outcome of disease) from tissue obtained from your surgery.

Neither you nor your regular doctor will receive reports of this research study. The results of this research study will not be placed in your health records. All of your information obtained in this study will be kept confidential either in a password-protected computer or in a locked file cabinet in a secure location.

Your participation will be over in this study when all the data has been collected and analyzed.

This is an investigational study. Up to 1,825 women will take part in this multicenter study. Up to 1125 will be enrolled at MD Anderson.

Eligibility Criteria:
Inclusion Criteria:

1. All women of Mexican and African descent ages 18 years or older.
2. Diagnosis of invasive breast cancer (histologically confirmed invasive adenocarcinoma, including ductal, lobular, medullary, tubular and mucinous cellular patterns) within the past 24 months.
3. Willing to complete a questionnaire.
4. Consent to tissue acquisition (remaining after surgery or preoperative core needle biopsy).

Exclusion Criteria:

1. Male gender
2. Inadequate tissue obtained for the four main clinical markers (ER, PR, Her-2/neu and Ki67).
Fed Study of Olmesartan Medoxomil Tablets 40 mg and Benicar® Tablets 40 mg

The objective of this study was to investigate the bioequivalence of Mylan's olmesartan medoxomil 40 mg tablets to Sankyo's Benicar® 40 mg tablets following a single, oral 40 mg (1 x 40 mg) dose administered under fed conditions.


Eligibility Criteria:
Inclusion Criteria:

* healthy, adult subjects, 18 years and older
* able to swallow medication

Exclusion Criteria:

* institutionalized subjects
* history of any significant disease
* use of any prescription or OTC medications within 14 days of start of study
* received any investigational products within 30 days prior to start of study
Survey on NIV Settings in the Intensive Care Unit for Acute Exacerbation of COPD

Introduction Chronic obstructive pulmonary disease (COPD) is a common condition and the fourth leading cause of death worldwide. With the rise of non-invasive ventilation (NIV), mortality among patients admitted for acute hypercapnic respiratory failure has decreased, though to a lesser extent than reported in the studies that validated this technique. We hypothesize that inappropriate initial ventilatory parameter settings for NIV could be associated with increased morbidity and mortality in this context.

Objective The primary objective of this study is to assess the initial NIV settings used in intensive care units (ICUs) and respiratory intensive care or medical intensive care units (MICUs) in this patient population. A secondary objective is to evaluate whether specific ventilatory settings are associated with mortality or the need for invasive mechanical ventilation (IMV).

Methods This is a prospective multicenter observational study aiming to include 976 patients. NIV settings will be recorded at initiation, after the first recommended arterial blood gas (ABG) evaluation (between 1.5 and 2 hours of ventilation), and at 24 and 48 hours. Patient characteristics, including medical history, clinical and biological parameters at admission, will be collected. Vital status and the need for IMV will be recorded at ICU discharge and on day 28 (D28).


Eligibility Criteria:
Inclusion Criteria:

* Adult COPD Patient
* Known or suspected COPD diagnosis as assessed by the attending physicians
* Admitted to a medical intensive care unit (MICU), respiratory intensive care unit, or MICU
* Hypercapnic respiratory distress
* NIV indication determined by the physician
* Covered by social security

Exclusion Criteria:

* Pregnant or breastfeeding women
* Other obstructive diseases (asthma, bronchiectasis, cystic fibrosis, bronchiolitis, pulmonary fibrosis, restrictive thoracic syndrome) Central hypoventilation (Ondine's syndrome, iatrogenic), neurological (neuromuscular disease), osteoarticular (kyphoscoliosis), or ENT-related causes
* Immediate need for intubation
* Acute pulmonary edema
* Contraindications to NIV (untreated pneumothorax, shock, cardiac arrest, uncontrolled vomiting, upper gastrointestinal bleeding, cervicofacial trauma, coma except when related to hypercapnia)
* Patients under legal guardianship
* Incarcerated individuals
Interventional Study of Active Weight Management in Patients With Type 2 Diabetes and Obesity in Routine Clinical Practice During 12 Months.

This study was aimed to achieve of long-term weight loss in T2DM patients by use of comprehensive lifestyle changes program, providing patients with structured diet, exercise plan, group behavioral support and group education. Additionally the study was designed to establish reduction of the body weight leads to the improvement of glycemic and lipid metabolism, and also reducing blood pressure level. The study was also directed to show that lifestyle changes program in T2DM patients can lead to decreasing of hospitalization rate and healthcare consumption. In order to demonstrate a change from standard of care, data were to be collected from a parallel cohort from the same centers.

Patients of active group were assigned to receive activities of the program for life style changes. Patients in control group were managed in frames of routine clinical practice. No any investigational drug therapy was used.

Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent. Written informed consent must be obtained before any assessment is performed.

  •≥ 18 years
* Type 2 diabetes
* The Body Mass Index is from 28 to 40 kg/m\^2

Exclusion Criteria:

* Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation.
* Type 1 diabetes
* Proliferative retinopathy
* Renal impairment: serum creatinine \>1.5 mg/dL, creatinine clearance \< 40 ml/min and/or proteinuria
* The lack of ability to perform the physical exercises due to the orthopedic or cardiovascular disorders
* Chronic alcoholism, acute alcoholic intoxication
Influence of Bariatric Surgery on Serum Levels of 26RFa

The 26RFa was recently discovered in the hypothalamus. In rodents it seems to be related to glucose metabolism and obesity. However, no data exists in obese patients or in patients with diabetes. Thus, the investigators planned to dose 26RFa level in obese patients before and after a sleeve gastrectomy in order to study the effect of a weight loss on its levels. The investigators will also dose 26RFa concentrations in obese patients with type 2 diabetes and in healthy volunteers with normal weight. Comparison of these different groups will permit us to better understand the 26RFa involvement in glucose concentration regulation and in obesity.

The 26RFa is an orexigenic neuropeptide of the Rfamides family, localized in two hypothalamic nuclei. Its increase induced obesity and it is elevated in obese rodents. In addition, in human, it is elevated in anorexic patients. However, no data exists in obese patients or in patients with diabetes. Thus, the investigators planned to measure 26RFa level in obese patients before and after a sleeve gastrectomy in order to study the effect of a weight loss on its levels. The investigators will also dose 26RFa concentrations in obese patients with type 2 diabetes and in healthy volunteers with normal weight. Comparison of these different groups will permit us to better understand the 26RFa involvement in glucose concentration regulation and in obesity.

The investigators will also measure other hormones known to have a major role in glucose metabolism and obesity (ie. insulin, adiponectin).

A meal test will be given to the volunteers in order to study the kinetics' of these molecules during and after food intake.

Eligibility Criteria:
1. Patients :

   1. Inclusion Criteria:

      * Obese patients (with or without type 2 diabetes) with a planned sleeve gastrectomy
   2. Exclusion Criteria:

      * HbA1c \>11 %.
2. Healthy volunteers :

   1. Inclusion Criteria:

      * 20 ≤ BMI ≤ 25 kg/m²,
      * with no treatment that may influence the glycemic control,
      * normal electrocardiogram,
      * no disturbance of the following blood tests: CBC, serum electrolytes, glucose,
      * negative serology of HIV, hepatitis B and C,
      * does not participate at another clinical trial in the last 3 months
   2. Exclusion Criteria:

      * severe medical or surgical history, particularly endocrine or cardiac,
      * oedema syndrome,
      * hypertension.
The Absorption and Metabolism of Seaweed Polyphenols in Humans

Brown seaweeds are a rich source of phlorotannins, a characteristic class of polyphenols which are unique to seaweeds of this type and can comprise 5 to 15 % of the dried weight. Unlike other classes of polyphenols, there is a lack of knowledge regarding phlorotannins and their bioavailability and bioactivity. The purpose of this study is to investigate the absorption and metabolism of seaweed polyphenols in humans. As part of an EC project (SWAFAX), an acute clinical intervention will be conducted to investigate the metabolism/ bioavailability of brown seaweed phlorotannins. Urine and plasma samples from 24 healthy volunteers that consumed a seaweed capsule containing polyphenols will be collected before and after the intervention. Data emanating from this project will provide strong scientific evidence for bioavailability and health promoting activity of a seaweed polyphenol extract in human volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Good general health
* Body Mass Index of 18-30 Kg/m2

Exclusion Criteria:

* Inability to swallow capsules
* Smoking
* Alcohol intake of \>21 units/wk
* Blood pressure \> 150/90 mmHg
* Any dietary restrictions or weight reducing diet
* Vegetarian
* Heamoglobin levels\< 125 g/l for male, \< 110 g/l for female,
* Gamma GT levels \> 80 IU/l
* Cholesterol levels \> 6.5 mmol/l
* Myocardial infarction or stroke in the previous 12 months
* Gastrointestinal disease or chronic gastrointestinal disorders
* Reproductive disorder
* Blood-clotting disorder
* Metabolic disorders
* Lipid-modifying medication
* Blood clotting mdication
* Antibiotic medication in previous 3 months before study
* Lactation
* Pregnancy
* Females of childbearing potential and not using effective contraceptive precautions
Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of SHR3824 in Type 2 Diabetes Mellitus Patients

The purpose of this study is to evaluate the pharmacodynamics (PD), pharmacokinetics (PK), safety and tolerability following single and multiple oral doses of 5mg to 20 mg SHR3824 in Type 2 diabetes mellitus patients.


Eligibility Criteria:
Inclusion Criteria:

* BMI:20-35kg/m2;
* Medically stable based on physical examination, medical history, laboratory results, vital sign measurements, and 12-lead electrocardiogram (ECG) at screening;
* On a stable regimen of antihyperglycemic therapy for at least 8 weeks prior to screening and had fasting plasma glucose (FPG) concentration lower than 13.9 mmol/L at baseline;
* Stable antihyperglycemic regimens could include a single oral agent (eg, metformin, a sulfonylurea, a thiazolidinediones ketone, a benzoic acid derivatives, a dipeptidyl peptidase-4 inhibitor, or an α-glucosidase inhibitor) with glycated hemoglobin (HbA1c) between 7.0% and 10.0%.

Exclusion Criteria:

* History of clinically significant diabetic complications, type 1 diabetes mellitus, or repeated severe hypoglycemic episodes.
* Pregnancy or breastfeeding;
* Significant acute or chronic medical illness, including renal impairment, or recent surgery;
* Donation of blood or plasma within the 4 weeks prior to the start of the study;
Modification of the Human Colon and Oral Microbiome by Allogenic HSCT

Allogenic HSCT brings significant changes in biodiversity and composition of the gut microbiome through antibiotic usage, the mucosal damage due to the chemo- and radiotherapy toxicity; compromised oral nutritional intake and graft-versus-host disease with gut damage as the complication. Aim of the study is to investigate the composition of the microbiota in both recipient and nursing relative donor, reveal changes in biodiversity after HSCT via 3-time points V3V4 16S rRNA and NGS sequencing of the colon and oral swabs, 3-indoxyl-sulfate measurement in the urine.


Eligibility Criteria:
Inclusion Criteria:

* indications to alloHSCT
* nursing healthy donors 3-55 y.o.

Exclusion Criteria:

* unable to give samples for the test
* graft rejection
* previous HSCT