cyrilzakka/clinical-trials huggingface dataset:
Activity for Diabetic Polyneuropathy

The proposed study will randomize participants with diabetic peripheral neuropathy into two groups. One group of participants will receive standard-of-care counseling while the other group will undergo supervised exercise and counseling to increase physical activity.

Type 2 diabetes (T2D) affects over 8% of Americans, and half will develop peripheral neuropathy, a progressive injury to the very longest nerves of the body. Our previous research has found that neuropathy can be detected early in its course and followed by examining nerves that reach to the skin using a small punch biopsy. These cutaneous nerves can be injured by high blood glucose, obesity and high triglycerides, but have the potential to regrow in response to treatments that improve these metabolic conditions. The proposed study will randomize participants with mild to moderate diabetic peripheral neuropathy to receive either generic annual counseling or an integrated program of moderate supervised exercise and actigraphy based anti sedentariness counseling.

Eligibility Criteria:
Inclusion Criteria:

1. T2D defined by ADA criteria.
2. Peripheral neuropathy based on the Toronto Diabetic Neuropathy Expert Group consensus criteria for "Confirmed diabetic sensorimotor peripheral neuropathy".
3. Moderate DPN severity with a UENS of 2-18.
4. Age between 30 and 75.
5. Under the care of an identified Primary Care Physician (PCP).

Exclusion Criteria:

1. Any alternative cause for peripheral neuropathy. The following tests must have been found normal within the last 12 months or will be performed pre-randomization: vitamin B12, serum protein electrophoresis and immunofixation. ANA and TSH may be obtained if clinically indicated and not available from clinical records.
2. Family history of a non-diabetic neuropathy in a first-degree relative.
3. Severe or longstanding neuropathy: UENS \> 18 or history of foot ulceration or amputation.
4. Participants taking Coumadin or oral factor X or thrombin inhibitor therapy will be considered on an individual basis by the site investigator.
5. Severe edema, dermatologic or lower extremity condition that would increase risk of skin biopsy.
6. A serious medical condition that might shorten life span or prevent exercise.
7. Subjects with obesity or hypertension considered in a dangerous range (BMI\> 45, systolic BP \>170, or diastolic BP \>110) and those who fail a medically supervised graded maximal stress test will be excluded from the study for safety reasons.
8. An inability to understand or cooperate with the procedures of the study
9. Females who are pregnant at screening or actively plan to become pregnant during the study period, because of the marked changes in metabolism anticipated during pregnancy.
10. If ,in the investigators assessment, that participation in the study would be limited by a person's weight, size, or other physical condition.
A Study in Healthy Volunteers to Compare the Pharmacokinetics of Sotorasib Administered as 1 or 2 Tablets

The primary objective of the study is to compare the pharmacokinetics (PK) of sotorasib administered orally as 1 tablet under fasted conditions to sotorasib administered orally as 2 tablets under fasted conditions.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male participants or female participants, between 18 and 60 years of age (inclusive), at the time of Screening.
* Body mass index, between 18 and 30 kg/m\^2 (inclusive), at the time of Screening.
* Females of nonchildbearing potential.

Exclusion Criteria:

* Inability to swallow oral medication or history of malabsorption syndrome.
* History of hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee) and in consultation with the Sponsor.
* Poor peripheral venous access.
* History or evidence, at Screening or Check in, of clinically significant disorder, condition, or disease, including history of myolysis, not otherwise excluded that, in the opinion of the Investigator (or designee), would pose a risk to participants safety or interfere with the study evaluation, procedures, or completion.
Opioid-Free Anesthesia in Modified Radical Mastectomy

The aim of this study is to evaluate the efficacy of opioid-free general anesthesia for breast surgeries in female patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients underwenting modified radical mastectomy
* Undergoing general anesthesia

Exclusion Criteria:

* Patients were excluded if they had Alzheimer's Disease, mental retardation, failure of locoregional anesthesia, contraindication for locoregional anesthesia.
Defining the Role of Endothelial Function Assessment Using EndoPAT in Cardiovascular Risk Screening : Comparison to Traditional Risk Assessment Tools and CIMT Testing

Our study aims to evaluate endothelial function using the non-invasive EndoPAT device, and compare this assessment to traditional cardiovascular risk calculation tools and carotid intima media thickness measurements. We look to determine whether the discovery of endothelial dysfunction provides incremental risk stratification over traditional and CIMT methods of cardiovascular risk assessment.

Atherosclerosis is a disease affecting the function of arteries, and is one of the underlying causes of stroke, heart attack and other cardiovascular diseases. These diseases are some of the highest causes of morbidity and mortality in North America. As an inflammatory disease that involves the endothelium of blood vessels, atherosclerosis causes arteries to stiffen and become blocked with plaques. This leads to decreased function of these arteries, which at first is asymptomatic, but at later stages can block blood supply to the heart or brain.

The Endo-PAT 2000 is a device designed to measure endothelial function using finger probes placed onto the finger tip of a patient. It is made to detect the presence of peripheral endothelial dysfunction, which develops under the same mechanisms as coronary disease. Risk factors for heart disease are well recognized, and include gender, race, weight, smoking status, and the presence of hypertension, diabetes, and elevated cholesterol. While these factors are monitored in the clinical setting, the actual damage to vascular endothelium has previously been difficult to quantify. The EndoPAT system offers a novel method of assessing endothelial function as an aggregate outcome of all of these risk factors.

Eligibility Criteria:
Inclusion Criteria:

* All patients 18 years of age and older are eligible

Exclusion Criteria:

* None except age \< 18 years
Obesity, Lifestyle and Work Intervention

The main aim of this study was to examine whether introducing a work intervention into a traditional lifestyle rehabilitation program for persons with BMI above 30, would affect the participants' ability to work and their lifestyle change. The investigators wanted to find out how the participants experienced their health, workability and work capacity, quality of life, diet and self-efficacy before and during the intervention

The background for this study was insights about obesity and sick leave. Obesity is related to lower labor force participation, increased sickness absence and reduced productivity. A Danish study from 2006 reported a yearly 1, 8 million extra days of work absence and close to 1.100 cases of disability pension related to obesity. A 2016-report from OECD show that persons with obesity between the ages 50-59 have three times as much work absence as those who do not struggle with obesity. This indicates that persons with obesity are a group where the need for work rehabilitation is important. Despite this connection, work focus has not been a part of lifestyle interventions for persons with morbid obesity until the last two years.

By introducing a work intervention into a traditional lifestyle rehabilitation program for persons with BMI over 30, the investigators wanted to examine whether this would affect the participants' ability to work and their lifestyle change. The study was designed as a randomized controlled study with an exploring prospective design. The intervention lasted 12 months and each patient had three visits (baseline, 6 and 12 months) at Muritunet, each lasting 4-2-2 weeks. The participants were randomized into two intervention, one with work intervention and one without.

Data material gathered at each stay consisting of self-reported forms, test, journal and individual interviews. These were all collected at baseline, and at six and twelve months.

Eligibility Criteria:
Inclusion Criteria:

* Participants with a Body Mass Index (BMI) \> 30 with or without comorbidity

Exclusion Criteria:

* People without a capacity to consent.
* People with severe alcohol and/or drug abuse.
* People with a major mental illness.
* Being pregnant.
* People with a health condition that contraindicates physical activity.
* People with or plan to apply for disability benefits.
* People with permanently adapted work.
Pulmonary Rehabilitation in Post-Acute Period of COVID-19 Infection

The aim of this study is to investigate the efficacy of pulmonary rehabilitation(PR) applied in the isolation processes of post-acute patients with mild and moderate symptoms who had positive COVID-19 test on dyspnea,muscle pain,chest expansion,lower limb muscle strength and dynamic balance,fatigue,anxiety and depression.

This study was conducted with 270 patients who were the COVID-19 test was positive and isolated in their homes during post-acute periods.While one of the groups (n=135) was asked to remain isolated at home by providing patient education,a PR program was applied for 4 weeks in addition to the patients in the other group(n=135).PR consists of patient education, breathing, in-house mobilization and range of motion exercises.As the evaluation parameters,pre-treatment and post-treatment dyspnea levels with Borg scale,muscle pain with visual analog scale(VAS),functional capacities with sit-up test,chest expansions with tape measure,respiratory frequency,fatigue level with fatigue severity scale,and emotional status with hospital anxiety and depression(HAD) scale were evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 28-45, positive COVID-19 test, being in the post-acute period, having symptoms of mild-moderate severity, respiratory rate ≤40 breaths / min, patients who can make video speech

Exclusion Criteria:

* Severe symptom involvement, fever more than 38 degrees, obese patients, patients with multiple comorbidities, patients with one or more organ failure, oxygen saturation in the blood ≤95%, a resting blood pressure of \<90/60 mmHg or\> 140 / 90 mmHg patients
Clinical Trial of Metal-Reinforced Teeth Designed for Endoscopic Clips

Postoperative gastrointestinal complications following ESD, EMR, and EFTR procedures, such as gastrointestinal bleeding, diverticula, fistulas, perforations, and stent fixation, can be effectively treated through gradual endoscopic procedures. The technical limitations of traditional endoscopic hemoclips restrict their application. Although endoscopic suturing techniques are emerging, most are still in the exploratory phase. Therefore, the investigators have developed metal-reinforced teeth for hemoclips. This initial clinical study aims to validate the safety, feasibility, and effectiveness of reinforced teeth in clinical applications. The investigators also aim to explore the uses and limitations of this technology. The primary outcomes are the technical success rate and the clinical success rate.

With the advancement of endoscopic technology, gastrointestinal defects following endoscopic submucosal dissection (ESD), mucosal resection (EMR), and full-thickness resection (EFTR), as well as complications such as gastrointestinal bleeding, diverticula, fistulas, perforations, and even fixation of esophageal stents, can gradually be treated through endoscopic procedures. This approach avoids surgical incisions and reduces patient recovery time. Traditional endoscopic hemoclips have limited application due to constraints such as arm extension distance, size of the clip's front teeth, and closing force. Therefore, the investigators have developed metal-reinforced teeth for hemoclips. This initial clinical study aims to validate the safety, feasibility, and effectiveness of reinforced teeth in clinical applications. The investigators also aim to explore the uses and limitations of this technology. The primary outcome measures include technical success rate and clinical success rate. Additionally, the investigators closely monitor procedure time, the number of clip uses during the procedure, and postoperative adverse events during follow-ups.

Eligibility Criteria:
Inclusion Criteria:

* 1. Gastrointestinal lesions that require clips include non-variceal upper gastrointestinal bleeding, post-endoscopic submucosal dissection (ESD) lesions in the gastrointestinal tract, fistulas, diverticula, perforations, and anchoring of self-expanding metal stents.
* 2. Expected survival greater than 30 days;
* 3. Written informed consent.

Exclusion Criteria:

* 1. Patients with diffuse gastrointestinal lesions, such as Crohn's disease and ulcerative colitis;
* 2. Patients who clearly require surgical intervention;
* 3. Serious cardio-pulmonary, hepatic or renal disease;
* 4. Intolerance to endoscopy;
* 5. Pregnant or lactating women.
Acetaminophen for the Reduction of Oxidative Injury in Severe Sepsis

Cell-free hemoglobin can be measured in the plasma of patients with sickle cell anemia, hemodialysis, after red blood cell transfusion, and in patients with sepsis. Cell-free hemoglobin in these patient population has been associated with poor outcomes, including an association with an increased risk of death. Acetaminophen may have a protective effect in these patient populations by inhibiting hemoprotein-mediated lipid peroxidation. The purpose of the present trial is to study the effect of acetaminophen on lipid peroxidation in adults with severe sepsis and detectable cell-free hemoglobin.

The primary hypothesis is that systemic markers of oxidative stress and lipid peroxidation, as measured by F2-isoprostanes, will be significantly lower in patients with severe sepsis and detectable cell-free hemoglobin who receive acetaminophen compared to placebo. The secondary hypothesis is that patients with severe sepsis and detectable cell-free hemoglobin treated with acetaminophen will have better clinical outcomes, including decreased incidence of acute kidney injury and lower rates of hospital mortality, compared to those who receive placebo.


Eligibility Criteria:
Inclusion Criteria:

* Males and Female \>=18 years old
* Admitted to an Intensive Care Unit
* Severe Sepsis
* Detectable plasma cell-free hemoglobin

Exclusion Criteria:

* patients who received acetaminophen in the past 48 hours prior to enrollment
* intolerance or allergy to acetaminophen
* measured AST/ALT \>400 U/L in the 24 hours prior to enrollment
* chronic liver disease defined by a Child-Pugh score \>4
* cannot swallow or have no enteral feeding access
* patients with no detectable cell-free hemoglobin
* patients transitioned to palliative care
* pregnant patients or women of childbearing potential without a documented pregnancy test
Outpatient Parenteral Antibiotic Therapy in the Metropolitan Area of Cologne

Many infectious diseases require a therapy that is administered intravenously due to a lack of oral treatments. Affected patients often have to stay weeks or even months in hospital just for receiving their therapy although they do not feel severely unwell.

Outpatient parenteral antibiotic therapy (OPAT) allows these patients under certain requirements to get discharged from hospital and apply the antibiotic treatment on their own. For these patients quality of life improves by feeling more comfortable at home and being able to participate in everyday life or even go back to work. For the hospitals a reduced inpatient health care means a clear reduction of costs.

The benefits of OPAT are obvious, shown by several studies, and in many countries e.g. the USA OPAT is a very well established way of treatment. In Germany however OPAT is used very infrequently and not in a standardized manner. This is probably due to inadequate knowledge of this form of treatment and deficits in the outpatient care structure, as OPAT is not reflected in the remuneration system of the German health care system despite internationally proven benefits.

The aim of this study is to identify and analyze possible obstacles to the implementation of OPAT into the standard patient care in Germany regarding financial, structural and medical limitations. Therefore the investigators intend to treat 120 patients in the metropolitan area of Cologne with OPAT and observe effectiveness, safety, logistics and acceptance to this kind of therapy.

If successful, the project should help to identify the potential of OPAT for Germany. If positive effects and feasibility can be demonstrated in the Cologne metropolitan region, OPAT could become an important therapy option with many advantages for certain patients.


Eligibility Criteria:
Inclusion Criteria:

* patients who get OPAT

Exclusion Criteria:

* patients who don't get OPAT or are not capable to give their informed consent
Study to Evaluate Safety & Efficacy of FLX-787-ODT to Treat Fasciculations in Tongue and Appendicular Muscle in Adult Subjects With ALS

The FLX-787-107 study will determine how well FLX-787-ODT works to reduce fasciculations in patients with Amyotrophic Lateral Sclerosis (ALS). The study will measure how often fasciculations occur, if tongue and muscle strength, speech, and swallowing are affected, and monitor any side effects that might develop while taking the investigational product. Participants will be assessed before and after taking a single dose of FLX-787-ODT. Approximately 15 people will take part in this study at one center in the United States. Participants will be in the study for a single clinic visit and receive a telephone call 7 days later to monitor for side effects.


Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of ALS diagnosis of less than 5 years.
* Greater than 6 fasciculations per minute noted at least in the tongue by clinical, ultrasound, or EMG evaluation.
* Normal oral cavity exam at screening.

Exclusion Criteria:

* Presence of clinically significant or unstable condition that would result in an increased risk of study participation or difficulty in interpretation of the study results.
* Tremor or other movement disorder that would interfere with recording.
* Presence of major gastrointestinal disorders, such as inflammatory bowel disease, diverticulitis, active peptic ulcer disease, or significant gastroesophageal reflux disease (i.e., not well-controlled on antacids or proton pump inhibitors), or oral or esophageal lesions/ulcers.
* Presence of laryngospasm or significant swallowing problems.
* Inability to tolerate a spicy sensation in the mouth or stomach.
* Actively using illicit drugs or history of chronic substance abuse within the past year prior to screening, including abuse of alcohol.
* Participated in a clinical study (except natural history studies without administration of an investigational product) within 30 days prior to screening.
* Pregnant, breastfeeding, or planning to become pregnant.
* Blood pressure of ≥160 mmHg systolic and/or ≥100 mmHg diastolic.
* Clinically significant abnormalities in laboratory findings (including screening complete electrolyte panel, complete blood count, liver function tests).
Synbiotics Cohort Study

Observational study exploring the clinical outcomes of infants with cow's milk allergy who are prescribed a hypoallergenic formula containing synbiotics.

A range of clinical outcomes will be collected from the medical records and in-person assessment of 60 fully or partially formula fed infants (aged \<13 months) who are prescribed a hypoallergenic formula containing synbiotics as part of usual clinical practice for the dietary management of cow's milk allergy

Eligibility Criteria:
Inclusion Criteria:

* Aged \<13 months
* Confirmed or suspected CMA- based on healthcare professional (HCP) judgement
* At baseline, parent(s) must already be exclusively or partially formula feeding their child (with a hypoallergenic or non-hypoallergenic formula) or have already made the decision to start exclusively or partially formula feeding
* Recently prescribed a hypoallergenic formula containing synbiotics

Exclusion Criteria:

* Exclusively breastfed infants
* Primary lactose intolerance
* Enterally fed infants
* Premature infants (born \<37 weeks) with a corrected age of less than 1 month
* Infants with contraindications to the use of hyopallergenic formula containing synbiotics
* Major hepatic or renal dysfunction
* Investigator concern around the ability of family to comply with protocol and requirements of study
Paricipant Preferences in the Treatment of Inflammatory Bowel Disease (IBD) in Europe

The purpose of this survey is to describe Crohn's disease (CD) participants' as well as ulcerative colitis (UC) participants' preferences towards the attributes of treatment with advanced therapies for IBD, including safety and efficacy profiles, frequency and route of administration (RoA) in a real-world setting.

This is a descriptive, observational, cross-sectional survey of participants with IBD. The survey will look into the preferences of participants towards the attributes of treatment with advanced therapies for IBD based on DCE (experimentally designed survey), including safety and efficacy profiles, frequency and RoA in a real-world setting, in European participants living with CD or UC.

The survey will involve data collection in a real-world setting via an online self-reported questionnaire hosted on the Carenity platform, an international participant community.

The survey will enroll approximately 600 participants. Participants will be enrolled in two observational cohorts:

* CD Participants
* UC Participants

This multi-center trial will be conducted in France, the United Kingdom, Italy, Spain, Belgium, Switzerland, the Netherlands.

Eligibility Criteria:
Inclusion Criteria:

1. Self-reported suffering from CD or UC.

Exclusion Criteria:

1. Have never been ever treated with prescription medications for CD or UC.

* Should be included in the study only once.
* Data collected from participants who subsequently withdraw their consent will not be included in or will be deleted from the database.
Involvement of Plasmatic Factors in the Peripheral Muscle Dysfunction of COPD Patients - In Vitro Study

Chronic Obstructive Pulmonary Patients is a defined by persistent airflow limitation that is usually progressive and associated with an enhanced chronic inflammatory response in the airways and the lung to noxious particles or gases. It is associated with an atrophy of the skeletal muscle that impairs the patient's prognosis. The biological mechanisms of this muscle atrophy have not been elucidated, and the "spill-over theory" has recently emerged. Indeed, in COPD patients, the pulmonary inflammation is associated with a systemic low-grade inflammation, and the increased pro-inflamatory molelcules in the blood - which constitute the cellular micro-environement of the muscle fibre - could activate the mechanisms of the cell atrophy.


Eligibility Criteria:
Inclusion Criteria:

35 to 85 years old

* COPD patients: association of symtoms (breathlessness, cough, sputum) and chronic exposure to inhalated risk factors (like tobacco smoke) and a FEV1/VC ratio \<70% assessed by a spirometry
* Healthy subjects: A sedentariness assessed by a Voorrips score \<9.4 and/or a report of \<150 min/week of moderate-to-vigorous physical activity

Exclusion Criteria:

* A recent COPD exacerbation (\< 4weeks)
* The decompensation of a comorbidity
* An antioxidant supplementation or medication
* A long-term systemic corticosteroid medication