cyrilzakka/clinical-trials huggingface dataset:
The Comparison of a Technology-Based System and an In-Person Behavioral Weight Loss Intervention

The primary aim of this study is to compare the changes in body weight between a technology-based system, an in-person behavioral weight loss intervention, and a combination of both during a 12 month behavioral weight loss intervention in adults. Sedentary, healthy overweight and obese adults will be recruited to participate. Assessments will be conducted at 0, 6, and 12 months. This is a randomized trial in which participants will be randomized to one of three groups: standard behavioral weight loss (SBWL), standard behavioral weight loss plus technology (SBWL+TECH), and technology alone alone (TECH).


Eligibility Criteria:
Inclusion Criteria:

* ages of 21-55 years
* Body mass index (BMI) between 25-39.9 kg/m2

Exclusion Criteria:

* Currently pregnant, pregnant in the last 6 months, or plan on becoming pregnant in the next 6 months.
* Currently participating in regular exercise for over 60 minutes/week.
* Taking any medications that affect body weight or metabolism (e.g. synthroid).
* Have any physical limitations that would prevent exercise.
* Currently being treated for coronary heart disease, diabetes mellitus, hypertension, or cancer.
* Have a history of myocardial infarction or other heart-related surgeries.
* Have a resting systolic blood pressure \> 150 mmHg or diastolic blood pressure of \> 100 mmHg or currently taking any medications that affect blood pressure or heart rate (e.g. beta blockers).
* Currently enrolled in a commercial weight loss program, participating in another weight loss study, or in a weight loss study in the last 12 months.
* Have lost \> 5% of current body weight in the past 6 months.
* Currently being treated for any psychological problems or taking any psychotropic medication.
* Currently do not have access to a computer and the Internet that can be used for this study. This requires a PC computer, the ability to load software for the technology system, an existing internet connection provided by the participant, and a dedicated USB port to allow the armband from the technology system to be connected to the computer for the download of information.
Randomized and Controlled Clinical Trial to Evaluate Bacterial Adhesion on Multi-Im® Transepithelial Components

This study evaluates the efficacy of Mutli-Im® transepithelial components in the inhibition of bacterial adhesion.

The control group will be the Multi-Im® transepithelial component with the conventional surface (Multi-IM® Machined) and the experimental group will be the Multi-Im transepithelial components with the Ti-Golden® surface (Multi-Im Golden) or with the nanogolden surface (Multi-Im® nanogolden). Periodontal indices and biofilformation will be assessed during 2 months after implant loading. Metagenomic analysis and PCR technique will be implemented to assess the biofilm formation.


Eligibility Criteria:
Inclusion Criteria:

* Indication of having to place at least three dental implants.
* Plate index ≤ 20% and absence of evidence of active periodontal disease.
* Bleeding index of adjacent teeth ≤ 30%.
* Probing depth in adjacent teeth \<4 mm.
* Not having used systemic antibiotics during the last 6 months.
* Non smoker.
* Possibility for observation during the treatment period.
* Having signed the informed consent.

Exclusion Criteria:

* Suffering any alteration or serious hematologic disease.
* Being undergoing or having received in the 30 days prior to inclusion:

radiotherapy, chemotherapy or immunosuppressive treatments, systemic corticosteroids and/or anticoagulants.

* Presence of malignant tumors, hemangiomas or angiomas in the area of implant placement.
* Patients undergoing treatment with bisphosphonate drugs, both orally and intravenously.
* Metabolic bone disease.
* Diseases that affect the oral mucosa.
* Diabetic patients.
* Severe parafunctional habits and/or temporomandibular joint disorders.
* Pregnant or lactating women.
* Physical or mental inability to maintain a good oral hygiene.
* Being participating in another study.
* In general, any inability to participate in the study.
RandOmized Study Exploring the Combination of radioTherapy With Two Types of Acupuncture Treatment: The ROSETTA Trial

The ROSETTA-trial will evaluate the effect of acupuncture as a complementary treatment parallel to radiation therapy in oncological patients. The trial is designed as a two-armed trial. Depending on the treatment study arm either verum- or Sham sham-acupuncture will be applied. Acupuncture is applied treatment bi-weekly during the first week of radiotherapy, thereafter weekly until the end of radiotherapy; the follow-up visits include clinical workup as well as questionnaires.

Adverse effects such as fatigue, pain, skin problems , nausea and vomiting are commonly known in patients undergoing irradiation alone or in combination with chemotherapy (RCHT). Patients suffering from these symptoms are constricted severely in their daily life and their quality of life (QOL) is often reduced. As examined several times, acupuncture can cause an amelioration of these specific disorders. Especially for pain symptoms several groups have shown efficacy of acupuncture. To what extent a difference between traditional acupuncture (verum-acupuncture) and false acupuncture (sham-acupuncture) can cause reduction of side effects and improvement of QOL is not clarified. Therefore, the ROSETTA trial is a randomized trial with two treatment arms.

The verum-group receives "real acupuncture" , while the Sham-group is treated with sham- acupuncture points. These points are "nonsense" needlepoints, which do not have any correlate in TCM.

Patients are going to get standardized questionnaires (EORTC QOL C-30) before their first, after their fourth and after their last acupuncture treatment. Patients will be questioned about their condition by the investigator. The answers will be documented according to the standardized scoring system CTCAE (Common Toxicity Criteria for Adverse Events).

Group A: Verum Acupuncture Needlepoints Bilateral PC 6, S 36, L 8, L 9 Unilateral R4, R 6

Group B: Sham Acupuncture Needlepoints 8 needles in the medioaxillary line below the 6th rib, bilateral 2 needles unilateral

Eligibility Criteria:
Inclusion Criteria

Patients meeting all of the following criteria will be considered for admission to the trial:

* treatment with radiotherapy
* age ≥ 18 years of age
* Ability ability of subject to understand character and individual consequences of the clinical trial
* written informed consent (must be available before enrolment in the trial)

Exclusion Criteria

Patients presenting with any of the following criteria will not be included in the trial:

* any contraindication to acupuncture
* known coagulopathy or anticoagulation therapy with bleeding time \> 4 minutes, thrombocyte count \< 50 000/μl
* missing compliance
* skin disease in the region of the acupuncture points
* refusal of the patients to take part in the study
* participation in another clinical study or observation period of competing trials,
GeneMatch: A Program of the Alzheimer's Prevention Registry to Match Individuals to Studies Based on Apolipoprotein E (APOE) Genotype

The purpose of the Alzheimer's Prevention Registry GeneMatch program is to identify a large group of people interested in participating in research studies or clinical trials based in part on their genetic background. This genetic information will be used to match interested individuals to studies, providing a recruitment resource to the Alzheimer's scientific community. Interested individuals should visit www.endALZnow.org/GeneMatch to join the GeneMatch program.

The primary objectives of the Alzheimer's Prevention Registry GeneMatch program are to (1) identify and characterize a large cohort of people who are interested in, and may be eligible to participate in, current and future preclinical Alzheimer's disease research studies and clinical trials based on their genetic background, and (2) provide information to these individuals about research studies for which they may be eligible, based in part on their genetic background. Cognitively unimpaired individuals age 50 to 90, inclusive, are eligible to enroll in GeneMatch. GeneMatch will provide participants with a genetic sample kit (a cheek swab) to test for a specific gene called apolipoproteins E (APOE). GeneMatch does not disclose the results of the APOE test to participants. GeneMatch may use the APOE test results to match participants to research studies. Participants are under no obligation to pursue these study opportunities.

Eligibility Criteria:
Inclusion Criteria:

* Age 50-90, inclusive
* Provide basic demographic, medical history, and contact information
* Consent to APOE genotyping without receiving results
* Live in the United States

Exclusion Criteria:

* Unable to comply with this project's protocol requirements
* Self-reported diagnosis of dementia or any other objective cognitive impairment syndrome
Long-term Mortality After Intensive Care Considering Comorbidity and Admission Diagnoses

This is a register-based study

The aim of this study is to investigate how common comorbidity is in different age groups and which comorbidity that has the greatest impact on mortality considering different admission diagnosis and after the acute phase compared to the general population. Also, how different degrees of comorbidity affect mortality, adjusted for other comorbidities and SAPS 3?

The study population included all patients \> 16 years old admitted to an ICU during the years 2006 to 2012 and registered in the Swedish Intensive Care Registry (SIR).

Hospital discharge diagnoses from in-patient care five years preceding the index time for the ICU admission were extracted from the National Patient Register (NPR) and linked to ICU admissions using unique person identity numbers. Follow-up for all-cause mortality were extracted from the cause of death register at NPR.

Eligibility Criteria:
Inclusion Criteria:

The study population included all patients \> 16 years old admitted to an ICU during the years 2006 to 2012 and registered in the Swedish Intensive Care Registry (SIR)

Exclusion Criteria:

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On-pump Beating Coronary Artery Bypass Grafting by Ventricular Assist

The investigators designed the randomized prospective study to evaluate the differences of inflammatory response and clinical outcome after on-pump beating coronary artery bypass grafting undergoing left ventricular assist versus biventricular assist in patients with severe left ventricle dysfunction.

Off-pump coronary artery bypass grafting (CABG) tends to have a lower incidence of postoperative complications and remarkable advantages in terms of hospital stay. However, some drawbacks include higher rates of incomplete revascularization and the hemodynamic deterioration during manipulation of the heart, more occurring in the cases of posterolateral anatomical constraints and cardiac dysfunction. It leads to urgent conversion to extracorporeal circulation (ECC) and increases the mortality. Although conventional ECC with cardioplegia arrest provides bloodless immovable field, intense systemic inflammatory response may contribute to hemodynamic unstability especially in patients already with severe cardiac dysfunction.

On-pump beating CABG, as a more comprehensive approach, not only facilitates stable hemodynamics and complete revascularization, but also supports myocardial lymphatic flow balance and decreases interstitial myocardial edema in the beating state. Especially in the high-risk patients,some findings suggested that off-pump CABG should be converted to on-pump beating CABG without hesitation, avoiding hemodynamic collapse and even catastrophic outcomes. Some investigators intentionally planned on-pump beating CABG aiming to some patients with severe left ventricle dysfunction. Furthermore, on-pump beating CABG with ECC assistance in a high-risk subgroup is also an acceptable trade-off between conventional cardioplegia and off-pump operations.

The above-mentioned ECC results about on-pump, beating-heart CABG pay much attention to the biventricular assist (BiVA). Nonetheless, much evidence also reveals that BiVA triggers an intense inflammatory response due to extracorporeal membrane lung and circuit line. Comparatively speaking, single left ventricular assist (LVA), with shorter circuit line, less priming volume and free of extracorporeal membrane lung, theoretically should reduce the inflammatory response and relative complications. As a result, aiming to the high-risk patients with severe left ventricle dysfunction, who need ECC assistance (BiVA or LVA), the investigators designed the randomized prospective study to evaluate: 1) the differences in myocardial injury as expressed by cardiac Troponin I(cTnI) and in inflammatory response by C-reactive protein (CRP), 2) the differences in the early postoperative outcomes including graft number, incidence of atrial fibrillation, in-hospital mortality and ICU stay.

Eligibility Criteria:
Inclusion Criteria:

* patients with severe left ventricle dysfunction with an ejection fraction (EF)≤40%, being scheduled for revascularization.

Exclusion Criteria:

* myocardial infarction within the preceding 4 weeks
* severe valve disease requiring valve replacement
* cardiac reoperations
Inflammation and Protein Restriction

There is strong scientific data that supports that short-term protein restrictive diets reduce surgical stress responses. The investigators are hoping to use the information collected from the blood serum and muscle tissue of healthy subjects to help understand the baseline and early changes in muscle energetic and cell-mediated inflammation. The study team hopes to use the data collected in this pilot study to compare with patients undergoing open abdominal aortic aneurysm (AAA) repair in a future study

Modulation of a patient's diet, specifically via short-term dietary protein restriction, can impact changes in cell energetics and dampen the normal subclinical inflammatory state. These changes can provide benchmarks for future research focused on using nutritional interventions aimed at improving the probability of a successful outcome following open aortic aneurysm surgery. The investigators will conduct a short term dietary restriction protocol to characterize these changes in a normal control cohort to be compared to patients which undergo surgery, to identify the optimal time points for sampling in the surgical population. These changes will be characterized by looking at inflammatory cells in the blood, proteins excreted in the urine, changes in microbiome signature identified by stool sample and oral swab, as well as changes in muscle energetics in small muscle biopsies.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers between 18 and 70 years of age

Exclusion Criteria:

* Age less than 18 years.
* The presence of any significant medical condition that might significantly confound the collection of biological data in the study including cancer, diabetes, inflammatory bowel disease (IBD), Advanced Renal Disease, Nut Allergy
* Unwilling to follow protocol
* Participation in another interventional clinical trial.
* Prisoners, pregnancy, or direct employees of the investigative team
Effect of Pulmonary Recruitment Maneuver (PRM) on Pain and Nausea After Laparoscopic Cholecystectomy

This prospective, blinded, randomized clinical trial investigates the effect on postoperative pain and nausea, when performing a ventilator-piloted PRM at the end of a laparoscopic cholecystectomy.


Eligibility Criteria:
Inclusion Criteria:

* elective laparoscopic cholecystectomy
* American Society of Anesthesiologists (ASA) physical status classification I-II (with the exception of body mass index over 35 kg/m2)
* written consent

Exclusion Criteria:

* conversion to open surgery
* Clavien-Dindo grade ≥ II
The Conus Brugada Syndrome Study

An observational, analytical, cross sectional study investigating the effects of Conus branch and Right Ventricular (RV) Branch occlusion on surface ECG and intra-cardiac electrograms in patients undergoing percutaneous coronary intervention (PCI).


Eligibility Criteria:
Inclusion Criteria:

* Aged 18-85
* Patients able and willing to give their written informed consent.
* Planned PCI of a CTO of a right coronary artery
* Planned use of an anchor balloon in the Conus branch or RV branch

Exclusion Criteria:

* Patients considered unsuitable to participate by the research team (e.g., due to medical reasons, laboratory abnormalities, or subject's unwillingness to comply with all study related procedures).
* Patients with a pre-existing, confirmed or possible diagnosis of Brugada Syndrome
* Marked ST elevation or J point elevation on baseline (prior to procedure) ECG in the precordial leads (V1-V3)
* Pregnancy. This will be tested by urine HcG measurement
Exploring Patient Treatment Preferences for Chronic Pelvic Pain: A Mixed Methods Study

This research is studying what things change the way people think about treatment for chronic pelvic pain (CPP). The study team is also interested in whether a web-based educational and self-management program for chronic pelvic pain changes how people think about chronic pelvic pain treatments. The program contains several different self-guided modules that include cognitive and behavioral structuring, self-administration of acupressure, engaging in physical activity, and a brief introduction to pelvic floor physical therapy techniques.

The study hypothesis is that patients with CPP will report that prior treatment experiences and most trusted source of medical information will be associated with baseline perceptions of various CPP treatment modalities.


Eligibility Criteria:
Inclusion Criteria:

* Have chronic pelvic pain, defined as moderate to severe pelvic pain (based on protocol) for greater or equal to(≥) 6-month duration, and is non-cyclic, occurring for at least 14 days of each month.
* Must be scheduled for a new patient visit with the Chronic Pelvic Pain and Endometriosis Referral Clinic within the Department of Obstetrics and Gynecology at the University of Michigan for treatment of chronic pelvic pain.
* Access to internet via computer or smartphone
* English-language proficiency (current version of the website is in English)
* The study team will attempt to recruit a diverse group of patients, with attention to diversity in race, ethnicity, education level, rural vs urban locality, sexual orientation, and gender identification.

Exclusion Criteria:

* Severe physical impairment precluding participating in internet-based program (for example, complete blindness or deafness)
* Prior care within the Chronic Pelvic Pain and Endometriosis Referral Clinic within the Department of Obstetrics and Gynecology at the University of Michigan for treatment of chronic pelvic pain (seen previously but meets criteria for new patient visit because \> 3 year interval since last clinic visit).
Insomnia Behavioral Intervention Study

This randomized pilot study (n=20) explores the effects of a behavioral intervention, that includes sleep hygiene improvements, in long-term users of sleeping pills, aiming to alleviate or stabilize symptoms of insomnia, monitor and decrease sleeping pill usage. Adherence will be monitored by an optional smartphone application.

This randomized pilot study has a goal of enrolling 20 study participants. The investigators will examine the effects of a behavioral intervention, that includes sleep hygiene improvements such as regular sleep schedules, with assisted coaching support from the research team. Study participants are long-term users of sleeping pills. The goal is to improve or stabilizie insomnia symptoms and decrease sleeping pill usage. Study participant adherence will be monitored by an optional smartphone application.

Eligibility Criteria:
Inclusion Criteria:

* Age of 55-85
* Use of sleeping pill medication for sleep at least 3 nights a week
* Diagnosed with Chronic Insomnia by a physician
* Speaks English above a 6th-grade level
* Has access to a smartphone and/or smart tablet and can use it
* Has regular access to internet

Exclusion Criteria:

* Presence of major depression or other severe psychopathology (e.g., bipolar disorder, psychosis, alcohol/substance abuse, etc.)
* Presence of an acute or severe medical condition which, in the opinion of the research team, would interfere with the study participant's ability to participate in the research study, such as an acute heart attack, recent severe trauma, etc.
Tele-physiotherapy on Post-stroke Hemiplegia Patients

The present preliminary randomized trial will be performed to compare the effectiveness of telephyisiotherapy plus physical exercises versus other conventional techniques (electromyographic biofeedback or conventional physiotherapy).

Participants will be chosen from Hospital Sagrado Corazón de Málaga, after the approval of the centre. One hundred and twenty patients with hemiplegia as a consequence of an ischaemic stroke will take part in the study. Selection criteria included to be older than 65 years, with two months of evolution after the stroke and with the left paretic side. In addition, they had to have a positive diagnosis of COVID-19. Positive cases will be confirmed by PCR. Due to the local sanitary regulations, all patients may require home confinement during 1 month without possibility to continue their rehabilitation program.

Physiological interventions started 20 days after the first negative PCR test.

Participants will be randomize in three different intervention groups, conventional therapy (n=40), carried out in the Hospital, biofeedback therapy (n=40), also conducted in the Hospital, and Telephyisiotherapy (TP) plus physical activity (n=40). The intervention period will last for three months, and participants will be re-evaluated 30 days later to confirm treatment effectiveness.

Measurements

Electromyographic activity and hand strength The mean electromyographic (EMG) activity will be determined with the Neurotrans Myoplus 2 Pro System (Verity Medical Ltd, UK), the same instrument used to carry out the intervention. The isometric strength (Nw) of the hand will be assessed with a hand-held digital dynamometer (Smedley digital hand dynamometer, RMS Ltd., UK).

Functional tests In the present work, the Fugl-Meyer will be used to determine the functional status of patients with stroke. The patients with better functionality had superior scores. In addition, the ability of the patients to perform basic daily living activities was determined through the Barthel index. Considering the advanced age of the participants, three extra-scales will be determined: the FRAIL scale, the short physical performance battery (SPPB) and the Strength, assistance in walking, rise from a chair, climb stairs and falls (SARC-F) scale will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Patients with hemiplegia as a consequence of an ischaemic stroke
* To be older than 65 years
* Voluntarily participate in the study

Exclusion Criteria:

* To suffer from dementia or severe cognitive decline
* To have any specific contraindication for sport practice (as suffering from joint pain, etc.)
* Those with any diagnosis of severe pathology (cancer, cardiovascular event, etc.) during the study period.