cyrilzakka/clinical-trials huggingface dataset:
The Effect of Exercise on Gut Microbiota in Type 2 Diabetic Patients

To investigate whether targeted lifestyle intervention (exercise), induces a change in intestinal fecal microbiota related to improved glycemic control and systemic inflammation in patients with DM type 2.

Diet and exercise are the most beneficial lifestyle interventions in patients with diabetes mellitus (DM) type 2, causing an increase in glucose tolerance.

One of the mechanisms through which these treatment modalities work might be explained through changes in the gut microbiota. Recent studies show that the chronic inflammatory status causing insulin resistance in DM type 2, is triggered by an increase in circulating bacterial lipopolysaccharide (LPS). Strict lifestyle intervention, such as exercise, so called Diabetes Bootcamp (DB), may manipulate the gut microbiota, reducing circulating LPS, causing an improvement of the insulin-mediated

Eligibility Criteria:
Inclusion Criteria:

* Subjects must meet the criteria for diabetes type 2 (a random blood sugar of \> 11.1 mmol/L and/or a fasting blood sugar lever of \>7.0 mmol/L and/or a blood sugar of \>11.1 mmol/L two hours after an oral glucose tolerance test and/or an HbA1c level of \>47 mmol/mol).
* Male or female (post-menopausal)
* Age above 45 years and below 70 years
* BMI \>30 kg/m2
* HbA1c \< 80 mmol/mol or \< 8,6% Subjects must use metformin
* Stable medication use
* Stable tension regulation (with or without medication)
* Subjects should be able to give informed consent

Exclusion Criteria:

* A history of cardiovascular event (Cerebrovascular event, myocardial infarction or pacemaker implantation)
* Severe-very severe lung emphysema (GOLD stage III-IV)
* Use of any antibiotics or proton pump inhibitor (PPI) in the past three months
* Use of any other antidiabetic medication besides metformin (e.g. SU-derivates, insulin)
* Use of a platelet inhibitor or cumarin derivate during
* Subjects participated in a lifestyle programme in the past 6 months (diet or exercise)
Observational Study of Misuse of High Dose Buprenorphine (Subutex® or Generic) in Opiate-Addicted Patients in France (Study P05186AM1)(COMPLETED)

The purpose of this study is to assess the risks of abuse, misuse and adverse events related to high dose buprenorphine. Approximately 1250 patients taking Subutex (Schering-Plough) or its Buprenorphine High Dose (BHD) generic (Arrow Laboratories) will participate in this study. Data will be collected using physician questionnaires and self evaluation patient questionnaires at the first visit and visits at 6 and 12 months.

Approximately 380 physicians will participate in this study. Patients will be enrolled in chronological order of consultations.

Eligibility Criteria:
Inclusion Criteria:

* Eligible patients will be those already having a prescription for Subutex or its BHD generic, or being proposed a prescription for Subutex or its BHD generic for the first time when consulting the participating physician.
* The patient must have been informed orally and in writing via the information notice and have signed it.

Exclusion Criteria:

* Criteria of non-eligibility will be related to the contraindications in the Marketing Authorization (MA) of Subutex or its BHD generic
ALT-801 in Healthy Overweight and Obese Volunteers to Study Safety and Tolerability

The purpose of the study is to assess the safety and tolerability in healthy overweight and obese volunteers administered single or multiple repeated doses of ALT-801.

This study has 2 parts. Part 1 involves a single dose of ALT-801 taken as a subcutaneous (SC) injection and will be approximately 36 days in duration. Part 2 involves 12 doses of ALT-801, once a week for 12 weeks, as a SC injection and will be approximately 116 days in duration. Each participant will enroll in only one part.


Eligibility Criteria:
Inclusion Criteria:

* Male or female healthy volunteers, age 18 to 60 years, inclusive
* Overweight to obese (BMI 25.0 - 40.0 kg/m2)
* MRI-PDFF≥ 10% (Part 2 only)
* Subjects must otherwise be in good general health, with no significant medical history, have no clinically significant abnormalities on physical examination at screening, and/or before administration of the initial dose of study medication
* Ability and willingness to attend the necessary visits to the study center
* Written informed consent signed prior to entry into the study

Exclusion Criteria:

* Women who are pregnant or breastfeeding
* History of diabetes or use of medications for the treatment of diabetes, or hyperglycemia or HbA1c ≥ 6.5%
* History of neoplastic disease, or personal or family history of multiple endocrine neoplasia or medullary cancer of the thyroid, with the following exceptions:

  1. Adequately treated non-melanomatous skin carcinoma
  2. Female with a history of benign cervical neoplasia if the subject has been compliant with surveillance and treatment as recommended by her physician
* Mentally or legally incapacitated, has significant emotional problems at the time of screening or expected during the conduct of the study
* Clinically significant laboratory abnormalities including:

  a. Impaired renal function
* Unlikely to comply with the study protocol or, in the opinion of the Investigator, would not be a suitable candidate for participation in the study
Social Support Counseling Intervention for Kidney Transplant Candidates

Virtual Coaching for Potential Kidney Transplant Patients

Individuals who are eligible for kidney transplant will be recruited by phone or email and randomized into two groups, control and interventional counseling. The control group will be given a simple survey to fill and return while the interventional counseling will go through a group education and counseling session along with members of their social support networks. The interventional counseling will then complete a pre and post survey (same as control group). Survey answers will be recorded within REDCAP.

Eligibility Criteria:
Inclusion

* Determined by transplant center to be suitable for continuation in evaluation for listing (or a member of that person's social support network)
* 18 Years of age or older
* English-speaking
* Willingness to participate with at least 2 social network members in the session and have calculator results shown to social network members (if a patient)
* Able to provide informed consent

Exclusion

* Prisoners
* Individuals with impaired ability to consent
* Pregnant females.
* Patients who choose to opt out of research.
* Non-English speaking
The Effect of the Stress Ball Used During Spinal Anesthesia on Pain and Anxiety

The aim is to determine the impact of the stress ball used during spinal anesthesia on pain and anxiety levels

Our planned study, which is intended to be conducted as a prospective randomized controlled trial, will include patients aged 18 and above who fall into category 3 and 4 according to the classification used in the study by Lucas et al., and who are undergoing cesarean section.Patient data including age, weight, height, body mass index (BMI), ASA (American Society of Anesthesiologists) score, gravidity, parity, history of abortion, gestational age, medical history, and surgical history will be recorded.The anxiety status of patients will be recorded using the State Anxiety Inventory (STAI-I) score both before and after the procedure.Patients will be divided into two groups using a randomization method. One group will be provided with a stress ball to squeeze during the administration of spinal anesthesia, while the second group will undergo spinal anesthesia without receiving a stress ball.All patients will receive intrathecal injection of 0.05% bupivacaine using a 25-gauge spinal needle. The Visual Analog Scale (VAS) will be assessed and recorded during the procedure to evaluate the patients' pain status.Additionally, the patient's blood pressure, pulse, and saturation levels will be recorded before starting the procedure and 2 minutes after the procedure initiation. Patient satisfaction will be evaluated after the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 and above.
* Patients with cesarean category 3 and 4.

Exclusion Criteria:

* Patients under the age of 18
* Patients undergoing emergency cesarean section
* Patients with bleeding disorders
* Individuals with psychological disorders
Soluble CD23 Expression in Asthma Patients Treated With OMA

This study involves a FDA approved drug, Omalizumab, used in the treatment of moderate to severe allergic asthma that cannot be controlled by standard treatment. It works on IgE to control the allergic reaction. We are looking at the effects on non-allergic asthma. We hope to prove that Omalizumab will have the same effect on non-allergic asthmatics as it does allergic asthmatics.

This is a 1 year placebo controlled study looking at moderate to severe asthmatics (allergic or non-allergic) who are controlled by medication.

Skin testing will be done to determine the allergic status, as well as a base line IgE done. The Omalizumab is administered by injection based on weight and IgE level, (once or twice a month).

At several times during the year pulmonary function test will be done, as well blood drawn for immunological assays (CD23 and FcER1 expression, TH1/TH2 cytokines, CD23 production). A battery of questionnaires will also determine quality of life(with asthma), psychological stress measures and parameters of clinical response.

Eligibility Criteria:
Inclusion Criteria:

Moderate to severe asthmatic (based on 1997 NHLBI guidelines), controlled by medication for at least 6 months, initial IgE level between 30 and 700 IU, weigh between 30 an 150 kg, otherwise healthy.

Exclusion Criteria:

Smoker, uncontrolled asthma, immunotherapy in past six weeks, other diseases
Acquiring Convalescent Specimens for COVID-19 Antibodies

Blood samples from participants who have recovered from COVID-19 infection will be obtained and studied. The goal of the research is to identify antibodies that have been generated by the patient to fight the COVID-19 infection. By identifying the most effective antibodies, scientists can make specific antibodies to use to prevent future coronavirus outbreaks or to treat patients with severe disease.

Coronavirus disease (COVID-19), an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has caused over 1,273,712 infections and over 69,458 deaths worldwide. Columbia University Irving Medical Center/NewYork-Presbyterian (CUIMC/NYP) has assembled a team of committed virologists, molecular biologists, chemists, and technologists to address this emerging threat. Monoclonal antibodies have become great additions to our therapeutic arsenal, primarily in treating cancer or autoimmune diseases. Recently, the use of monoclonal antibodies in combating infections such as respiratory syncytial virus and HIV have also become clear. In recent years, advanced cell sorting and sequencing technologies have been utilized to identify neutralizing antibodies from human B cells. This protocol will outline our approach to obtaining blood specimens from participants who are recovering from COVID-19 infection. Potential participants will be referred by health care providers from within the CUIMC/NYP system and from outside institutions. If the potential participant agrees to be contacted, study staff will call them to review the informed consent, eligibility criteria and study procedures, and set up a study visit for blood draw. Monoclonal antibodies that could potently neutralize 2019 novel coronavirus (2019-nCoV) and related coronaviruses will be isolated from these specimens. Candidate monoclonal antibodies will then be optimized and evaluated for therapeutic potential. The ultimate goal would be able to produce a monoclonal antibody that could confer protection during an outbreak or be utilized to treat patients with severe COVID disease.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 65 (inclusive)
* Confirmed COVID-19 infection by a FDA-approved molecular based assay (including those under emergency use authorization) of respiratory or blood specimens;
* If symptomatic with COVID-19, must have evidence of improvement of symptoms and a duration of at least 4 weeks from the onset of symptoms to day of enrollment;
* If asymptomatic, must have a duration of at least 4 weeks from first positive molecular based COVID-19 assay to day of enrollment

Exclusion Criteria:

* \<18 years or \>65 years old
* No confirmed diagnosis of COVID-19
Chronic Alcohol, Stress Inflammatory Response and Relapse Risk

The purpose of this study is to examine potential stress and immune systems adaptations underlying craving and relapse vulnerability in alcohol dependent (AD) individuals and social drinkers (SDs) with and without high levels of depressive symptomatology (+dep / - dep). Using the investigators experimentally validated guided imagery procedure, the investigators propose to examine the response of brain stress and immune systems to personalized guided stressful imagery using subjective, physiological and neurobiological assessments in 60 healthy controls and 60 alcoholic dependent individuals with and without depressive symptomatology.


Eligibility Criteria:
Inclusion Criteria:

* ADs: Male and females, aged 18-50 years, meeting current DSM-IV criteria for alcohol dependence consuming more than 25 drinks / week.
* SDs: Male and females, aged 18-50 years. Must not meet either current or lifetime DSM-IV criteria for alcohol/drug abuse. They must have demonstrated weekly alcohol use over the past year but no more than 25 drinks / month with no occasion of binge drinking (5 or more drinks-men; 4 or more -women).
* ADs and SDs must self-report depression ratings at levels to match one of the two following groups: a) a score of 20 or above in the Center for Epidemiologic Studies - Depression Scale (CES-D), or b) a score between 3 -20 on the CES-D
* Weekly alcohol use as documented by positive urine toxicology screens (AD only).
* Good health as verified by screening examinations and medical and screening
* Able to read English and complete study evaluations.
* All participants must voluntarily provide informed consent and sign the informed consent document.

Exclusion Criteria:

* Meeting current criteria for dependence on another psychoactive substance, excluding nicotine.
* Having any current Axis I psychiatric disorders and requiring treatment/medication for these conditions.
* Having significant underlying medical conditions requiring medication.
* Women who are pregnant or nursing.
Comparison of Rocuronium Induced Neuromuscular Blockade in Late Second Trimester Pregnant and Non-pregnant Women

The present study is to compare the onset and duration of rocuronium in late second trimester women and non-pregnant women undergoing general anesthesia.

Pregnancy induces physiological changes. Plasma volume, cardiac output, hepatic blood flow and protein binding are changed from the first trimester of pregnancy. These physiological changes give effect to the onset and duration of neuromuscular blocking drugs.

Rocuronium is a commonly used neuromuscular blocking drug categorized as FDA category B. Rocuronium is widely used for pregnant women. Previous studies have evaluated the onset and duration of rocuronium in postpartum women. Lately, the investigators have evaluated the onset and duration of rocuronium in early second trimester pregnant women and the duration was significantly longer in early second trimester women compared to non-pregnant women.

Since there is little research on the onset and duration of rocuronium in the late second trimester pregnant women, the investigators planned the present research.

Eligibility Criteria:
Inclusion Criteria:

* women undergoing general anesthesia

Exclusion Criteria:

* liver disease
* renal disease
* diabetes mellitus
* asthma
* allergic to specific drugs
* BMI\>30 or \<18
Obesity Awareness, Physical Activity Level and Sedentary Behavior in Obese Women

It is known that the incidence of obesity, which is a global health problem, is higher in women. The aim of this study is to examine the relationship of obesity awareness with physical activity level and sedentary behavior in obese women.

Obese people are at risk for medical conditions that can lead to greater morbidity and mortality. It is known that the incidence of obesity, which is a global health problem, is higher in women. Lack of physical activity and sedentary behavior are well-known risk factors for obesity and the relationship between them has been supported by many studies. As a matter of fact, some studies have reported that public health programs should focus on increasing individuals' physical activity levels as well as reducing sitting time. While examining the sedentary behavior and physical activity levels of obese women, evaluating their obesity awareness status, can facilitate increasing their awareness of the disease, initiating and complying with treatment. The aim of this study is to examine the relationship of obesity awareness with physical activity level and sedentary behavior in obese women.

Eligibility Criteria:
Inclusion Criteria:

* The women who are ages between 18-65 years,
* BMI ≥ 30.0 kg/m2 according to WHO classification.

Exclusion Criteria:

* BMI \< 30.0 kg/m2 according to WHO classification,
* Male participants,
* Inability to cooperate with assessments,
* Those who have had severe trauma or surgery that limit physical activities in the last 6 months,
* Those who have orthopedic, neurological, cardiovascular problems that limit / prevent ambulation,
* Pregnancy or suspected pregnancy,
* Individuals are included in a rehabilitation program.
Computerized Lung Sound Analysis

This clinical trial is conducted within the research project 'Computerized Lung Sound Analysis'. The research goal is the development of a system enabling the automatic classification of lung sounds, which will result in a decision support system for physicians.

The objective of this trial is to create a small lung sound corpus, enabling the development of a prototype of the described system. Therefore, investigators record lung sounds with several lung sound transducers distributed on the posterior chest of human test subjects.

In this clinical trial investigators record lung sounds over the posterior chest of human test subjects. The subjects are either lung-healthy (control group) or subjects with pneumothorax condition or pulmonary fibrosis. The lung sounds are recorded in supine position on an examination table. A foam pad with several lung sound transducers is placed under the back of the subjects. During the recording the subjects wear a nose clip and hold a pneumotachograph with both hands. The subjects are instructed to breath at a certain airflow rate during inspiration, with natural breathing during expiration. For each subject investigators simultaneously record 30 seconds of the airflow signal and the lung sounds from 16 lung sound transducers.

Eligibility Criteria:
Inclusion Criteria:

General:

* Smoker and non-smoker
* 'Lung-healthy' subjects (control group), subjects with pneumothorax or subjects with pulmonary fibrosis

Additional for 'lung-healthy' subjects:

* COPD \< 3 (GOLD Criteria)

Exclusion Criteria:

General:

* Body Mass Index \> 30
* Preceding thoracic surgery
* Non-cooperation of the subject
* Intubated or tracheostomized subjects

Additional for 'lung-healthy' subjects:

* Disease of the respiratory system
* Taking medication influencing the respiration
A Research Study Looking at How Semaglutide Works in People With Type 2 Diabetes in Spain, as Part of Local Clinical Practice

The purpose of the study is to collect information on how semaglutide works in real world patients. Participants will get semaglutide prescribed to them by their doctor. The study will last for about 6 to 8 months. Participants will be asked to complete some questionnaires about their health and diabetes treatment. Participants will complete these during their normally scheduled visits with their doctor.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent obtained before any study-related activities (study-related activities are any procedures related to recording of data according to protocol)
* The decision to initiate treatment with commercially available semaglutide has been made by the patient/Legally Acceptable Representative and the treating physician before and independently from the decision to include the patient in this study
* Male or female, age 18 years or older at the time of signing informed consent
* Diagnosed with type 2 diabetes at least 12 weeks prior to inclusion
* Available and documented haemoglobin A1c (HbA1c) value equal to or less than 12 weeks prior to initiation of semaglutide treatment

Exclusion Criteria:

* Previous participation in this study. Participation is defined as having given informed consent in this study
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
* Treatment with any investigational drug within 90 days prior to enrolment into the study
* Hypersensitivity to semaglutide or to any of the excipients
Optimization of Nutritional State on the Outcome of Patients with Acute Exacerbation of Bronchiectasis

Bronchiectasis is a chronic respiratory condition characterized by the abnormal and permanent dilation of the bronchi, leading to recurrent respiratory infections, chronic cough, and significant morbidity. The disease has gained increasing recognition due to its rising prevalence and the substantial burden it places on healthcare systems .

Recent studies have highlighted the importance of nutritional status in managing chronic respiratory diseases, including bronchiectasis. Malnutrition is prevalent among patients with bronchiectasis, particularly those experiencing frequent exacerbations. It has been shown that underweight patients have lower lung function and may face worse clinical outcomes compared to those with normal weight . Specifically, a study found that underweight individuals had a significantly lower forced expiratory volume in one second (FEV1) compared to their normal-weight counterparts, indicating a direct correlation between nutritional status and respiratory function .

To evaluate the effects of nutritional optimization on clinical outcomes in patients experiencing an acute exacerbation of bronchiectasis. Specifically, the study seeks to:

* Assess the Relationship Between Nutritional Status and Clinical Outcomes\*: To investigate how improvements in nutritional status, measured through dietary intake, body weight, and biochemical markers, correlate with clinical outcomes such as length of hospital stay, frequency of exacerbations, and overall recovery.

  * \*Evaluate the Effectiveness of Nutritional Interventions\*: To determine the impact of specific nutritional interventions (e.g., high-protein diets, caloric supplementation, and micronutrient support) on the health status and recovery of patients during acute exacerbations.

Eligibility Criteria:
Inclusion Criteria:

* \*Age\*: Adults aged 18 years and older.

  * Diagnosis\*: Confirmed diagnosis of bronchiectasis, as established by clinical evaluation and imaging studies (e.g., chest CT scan).
  * Acute Exacerbation\*: Patients presenting with acute exacerbation symptoms, such as increased sputum production, worsening dyspnea, or chest pain.
  * Nutritional Assessment\*: Patients identified as malnourished or at risk of malnutrition based on the Subjective Global Assessment (SGA) or similar nutritional screening tools.

Exclusion Criteria:

* \*Cognitive Impairment\*: Patients with cognitive impairments that affect their ability to participate in the study or adhere to nutritional recommendations.

  * Current Enteral Feeding\*: Patients receiving enteral nutrition or those with a feeding tube.

Recent Nutritional Interventions\*: Patients who have recently undergone significant nutritional interventions (e.g., dietary changes, supplementation) within the past three months prior to enrollment.

\*Pregnancy or Lactation\*: Pregnant or lactating women, due to the need for specific nutritional considerations.