cyrilzakka/clinical-trials huggingface dataset:
Using Peers to Promote Exercise in Older Adults

A randomized controlled trial to evaluate the effects of a 12-month telephone-supervised, home-based physical activity intervention, delivered via health educators versus supervised, trained peers, on physical activity patterns. Inactive men and women ages 50 years and older will be randomly assigned to one of these two programs or to an attention-control arm.

BACKGROUND:

Despite the recognized benefits of regular physical activity, older adults remain among the most inactive segments of the U.S. population. A number of studies have demonstrated the health impact and resultant reduction in chronic disease risk achieved by improving physical activity patterns. Effective telephone-based counseling approaches for promoting and sustaining regular physical activity among older adults have been developed and validated. Such mediated interventions provide a level of individual tailoring and ongoing support to long-term adherence, while allowing for ongoing program delivery that is more flexible, convenient, and potentially lower-cost than face-to face program delivery formats. Telephone-based delivery format also allows for potentially greater reach into segments of the older population that may find it difficult or unappealing to come to community settings on a regular basis.

DESIGN NARRATIVE:

A 12-month randomized trial in which women and men ages 50 years and above living in the San Francisco Bay area who meet medical and physical activity criteria, following a baseline evaluation, be randomized to one of three study arms: telephone-supervised, home-based physical activity instruction via a trained health educator; telephone-supervised, home-based physical activity instruction via a supervised peer facilitator; or an attention-control arm consisting of health educator-based telephone delivery of non-physical activity oriented health information and support. All subjects will have a follow-up evaluation at 6 and 12 months.

Eligibility Criteria:
Women and men ages 50 years and above of the San Francisco Bay area who are free of any medical condition or disorder that would limit participation in moderate intensity exercise, not hypertensive, stable on all medications, possess English-speaking and reading skills, and are available and able to participate in the evaluations and intervention.
Electro-acupuncture to Treat Disorder of Consciousness

With the rapid development of life support technology, more and more people can survive severe brain injury. Some survivors regain consciousness after a period of coma, however, many patients develop prolonged disorders of consciousness (DOC), which poses a therapeutic challenge for clinicians and a heavy burden for their families. The investigators design an Electro-acupuncture to treat disorder of consciousness (AcuDoc) trial with the aim of validating the clinical effect of electroacupuncture in treating DOC and exploring its therapeutic mechanisms by integrating EEG, neuroimaging, evoked potential tests, and behavioral assessments.

The AcuDoc trial is a single-center, prospective, triple masking, randomized, sham electroacupuncture-controlled study. A total of 50 adult patients with DOC and 25 healthy subjects will be enrolled in the study . Patients will be randomized into electroacupuncture (EA) group or sham EA group (1:1). All patients will receive EA or sham-EA treatment in the supine position at 9 am for 30 minutes once a day for consecutive 14 days and healthy subjects will receive no treatments. The primary objective is to determine the therapeutic benefit of electroacupuncture on the recovery of consciousness in patients with DOC after a 2-week intervention. Key secondary objective is to investigate the effect of electroacupuncture on the circuitry of consciousness using a multimodal approach integrating EEG, neuroimaging (rs-fMRI, amide proton transfer imaging, intravoxel incoherent motion imaging, neurite orientation dispersion and density imaging), and evoked potentials (SEP, BAEP). Other secondary outcomes include the effect of EA on the assessment of brain-computer interface after a 2-week intervention and on the Glasgow Outcome Scale-Extended score at 30 days and 90 days .

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years;
2. With cerebral damage due to TBI；
3. Diagnosed with UWS or MCS based on at least two CRS-R assessments;
4. From 4 to 16 weeks from the onset of brain injury;
5. Informed consent obtained.

Exclusion Criteria:

1. With a history of neurological or psychiatric disorder prior to the brain injury;
2. With uncontrolled seizures or status epilepticus;
3. Unstable vital signs and requiring the use of vasoactive agents;
4. With the use of general anesthetics or central acting sedative;
5. Without intact skin at acupoints or sham points;
6. Concomitant medical illness that would interfere with the outcome assessments and/or follow-up
7. Pregnant patients;
8. Currently participating in other investigational trials;
9. High likelihood of not adhering to the study treatment or the follow-up regimen
Effects of Plyometric Exercises on Static and Dynamic Balance of Children With Down,s Syndrome.

Down syndrome is a condition in which a person has an extra chromosome. Typically, a baby is born with 46 chromosomes. Down syndrome is a genetic condition that causes mild to serious physical and developmental problems. Symptoms associated with the syndrome include mental retardation, distinctive facial characteristics, and increased risk for heart defects and digestive problems, which can range from mild to severe.. Early treatment programs can help improve skills. They may include speech, physical, occupational, and/or educational therapy. The aim of the the current study is to determine the effects of plyometric exercise on static and dynamic balance in children with Down syndrome

This will be a randomized controlled trail. After approval from ethical committee, data will be collected from rising sun institute of special education, Lahore. Total sample size will be 20 and there will be two groups. Group A will be given with Standard Physical therapy treatment twice a week for 8 weeks. While group B will be given with plyometric exercises along with standard physical therapy treatment twice a week for 8 weeks. Patients will be evaluated before and after the intervention on Pediatric balance scale, time up and go test, five times sit to stand. Data will be analyzed on SPSS 26.0 and necessary analysis will be done after checking the normality of data.

Eligibility Criteria:
Inclusion Criteria:

* 6 to 12 years of age both genders will be included.
* Children with medical diagnosis of DS.
* Able to follow the command

Exclusion Criteria:

* Recent injury to lower extremities.
* Children with cerebral palsy and other neuromuscular disease will be excluded.
RPSA as a Potential Prognostic Biomarker of Pancreatic Cancer

PDAC (Pancreatic ductal adenocarcinoma) represents 90% of pancreatic tumors. The prognosis of PDAC remains poor at this time. Its management is based on surgery for early stages, associated with neoadjuvant and adjuvant chemotherapy. However, around 80% of patients will relapse after surgery. There is a lack of efficient biological biomarkers of PDAC, especially for prognosis. To date, CA19-9 is commonly used despite its lack of sensitivity and specificity.

Ribosomal protein SA (RPSA) is a transmembrane receptor localized at the cell surface but also in the cytosolic and nuclear regions. RPSA interacts with many proteins in the extracellular matrix (ECM), including laminin-1 and elastin. RPSA in involved in different cellular functions such as cell adhesion, migration, proliferation and differentiation. The expression of RPSA is increased in many cancers including breast, lung, prostate, pancreatic, etc. It could represent a molecular biomarker of tumor invasion and metastatic abilities. Moreover, the concentration of RPSA could be measured in the serum of patients with PDAC. Recent data suggest that a modification of the RPSA concentration could be a prognostic biomarker of PDAC.

The aim of this study is to explore the potential implication of RPSA as prognostic biomarker of PDAC.

Eligibility Criteria:
inclusion criteria :

* Patients treated at the Reims University Hospital for a resectable or potentially resectable pancreatic tumor, with or without neoadjuvant chemotherapy
* Adults (aged more than 18 years old)
* Patients who have signed the informed consent form

exclusion criteria :

* Patients with a prior history of cancer (excluding basal cell carcinoma or in situ cervical cancer that received conventional cancer treatment).
* Minors
* Patients for whom PDAC is not the retained diagnosis
Profiling of Circulating Immune Cells to Uncover Response Signatures to Anti-PD1 Immunotherapy in Melanoma Patients

Despite being standard of care, there are still many medical requirements related to immune checkpoint blocker based therapies such as identify patients susceptible to respond with the less adverse events, evaluate the clinical benefit of adjuvant treatment /risk of relapse and design new strategies for non-responder patients.

Thus, this project aims at understanding the impact of anti-PD1 on the immune system through investigation of the phenotypic, functional, metabolic and transcriptomic profiles of circulating DC subsets and effectors in response to anti-PD1 therapy in melanoma patients.

The primary objective of the study is to identify the biomarkers of response to anti-PD1 according to the type of patient before the start of the treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patient with histologically confirmed melanoma (stage I, II, III or IV based on AJCC classification)
* Able to sign the informed collection consent for the retrospective part or to express their non-opposition to the research for the prospective part of the study

Exclusion Criteria:

* Subject under guardianship or subject deprived of freedom
* Persons benefiting from special protection (as defined in Articles L1121-5 and L1121-8 of the Public Health Code): minors, pregnant or breastfeeding women, adults protected by law (under guardianship, curatorship or deprived of liberty) and persons hospitalized without their consent (as defined in Articles L3212-1 and L3212-3 of the Public Health Code).
* ocular melanoma
Immediate Versus Delayed Treatment of Odontogenic Infections

The objective of this study is to compare the physiologic resolution of dental infections between immediate tooth extraction (control group) and administration of systemic antibiotics and delayed extraction (study groups 1 and 2). A secondary objective is two compare two different antibiotic regimens in the delayed extraction groups (study group 1 and 2).

This is a prospective partially randomized clinical trial. Patients 2-11 years old who have a vestibular swelling associated with an odontogenic infection are being studied. Subjects will self-select into the control or study group. All subjects will be offered to have the tooth extracted on the day of diagnosis, and if this treatment is chosen they will join the control group (group 1). Subjects who defer treatment will be placed on amoxicillin and will be placed into the study group. The study group will be randomized into two parallel study groups that either have average dose antibiotics for 10 days (group 2), or maximum dose antibiotics for 5 days (group 3).

Eligibility Criteria:
Inclusion Criteria:

* Patients who present to the dental clinic or Boston Children's Hospital emergency room
* Odontogenic origin associated with a primary tooth and limited to the buccal vestibule only
* Ages of 2-11 years old
* Primary Caregiver present
* English speaking
* American Society of Anesthesiologists (ASA) classification of I
* None or current systemic antibiotic therapy regimen \< 24 hours
* Able to take medication orally
* Those patients who choose to participate in the study

Exclusion Criteria:

* Infection that has spread beyond the buccal vestibule, or not detectable
* Infection is associated with a permanent adult tooth
* Ages of \<2 years old or \>11 years old
* American Society of Anesthesiologists classification of II or greater or poor general health.
* Renal impairment
* Immunosuppressive disease
* Recent antibiotic therapy in the last 1 to 30 days
* Allergy to penicillin
* Unable to take oral medications
* Decline participation
Acute Effects of Different Macronutrient Compositions and Meal Distributions of the Food

About thirty participants, of varying degrees of obesity or being non-obese, without serious concomitant diseases consume either a high- or a low- carbohydrate beverage. The beverage is also consumed either as one single drink or as 5 small portions in the morning and are tested for effects on major cardiovascular risk markers and on metabolic rate for three hours on each occasion.

Thirty participants come to the metabolic ward at about 8 o´clock in the fasting state and stay until lunch on four occasions each. The participants are randomized to the order of the test meals. The meals have a total caloric content of 750 kcal and have either 50% of energy from carbohydrates (low fat) or 20% of energy from carbohydrates (low carb.). The meals are consumed on one occasion in the morning or divided in 5 portions (150 kcal each) for every 30 minutes, i.e. total combinations of meal composition and of meal distribution is 4. Effects of the food on p-glucose, s-insulin, blood-lipids, hormones and on metabolic rate is measured by blood tests or by indirect calorimetry (for metabolic rate). Sense of satiety is measured by visual analogue scales.

Eligibility Criteria:
Inclusion Criteria:

* Healthy participants \> 18 years with or without obesity

Exclusion Criteria:

* Major illnesses,
* thyroid diseases,
* need to take prednisolone,
* psychiatric disease,
* inability to understand Swedish
Study Comparing Tigecycline and Imipenem/Cilastatin in Chinese Subjects With Complicated Intra-Abdominal Infections

The primary objective of this study is to compare the safety and efficacy of an experimental antibiotic to a marketed antibiotic in the treatment of Chinese subjects with complicated intra-abdominal infections. \<br /\>


Eligibility Criteria:
Inclusion Criteria:

· Hospitalized male or female subjects over 18 years of age

Exclusion Criteria:

· Subjects with any concomitant condition that, in the opinion of the investigator, would preclude an evaluation of a response or make it unlikely that the contemplated course of therapy or follow-up visits could be completed.
LAMS Choledochoduodenostomies: With or Without Coaxial Plastic Stent

The aim of the study is to evaluate technical, clinical and safety outcomes of lumen-apposing metal stent (LAMS) with and without a coaxial double-pigtail plastic stent (DPS) in EUS-guided choledochoduodenostomies (CDS) for the management of biliary obstruction.

The introduction of specific biliary lumen-apposing metal stents (LAMS) represented a great technical improvement in EUS-guided transmural Biliary drainage (BD) of distal malignant biliary obstruction Data is still limited, but recent studies and reviews have been reported with acceptable technical and clinical success. However, some concerns exist regarding its safety, as secondary adverse events

There are doubts concerning the possible benefits derived from the insertion of double-pigtail plastic stents (DPS) within the lumen-apposing metal stents (LAMS) in the EUS-guided choledochoduodenostomy (CDS). Our hypothesis is that adding a coaxial plastic stent may offer benefits in terms of safety in CDS.

Eligibility Criteria:
Inclusion Criteria:

* Distal biliary strictures,
* A prior failed attempt at biliary drainage
* informed consent provided by the patient.

Patient exclusion criteria were as follows:

* younger than age 18 years,
* coagulopathy (international normalized ratio \>1.5, marked thrombocytopenia with a platelet count \<50,000/mL, or patient on anticoagulation therapy),
* critical illness.
DxH520 Pediatric Reference Interval Verification

Results from this study will be used to verify that the published pediatric reference intervals are met on the DxH 520 Hematology Analyzer for the pediatric age ranges.

Pediatric specimens from each age range will be tested from apparently healthy children. Ten male and Ten female are required for each age range. The values will be assessed against published reference ranges to verify that the values obtained fall within the expected reference interval for the age ranges listed below:

1. Neonate: 0 to 30 days
2. Infant: \> 30 days to 2 years
3. Child: 3 years to 12 years
4. Adolescent: 13 years to 21 years

Eligibility Criteria:
Inclusion Criteria:

* All subject genders, race and ethnicity will be included in the study. Pediatric samples will be targeted for this study within the specified age ranges.
* Specimens should be from apparently healthy individuals.
* Samples from inpatient and ED visits maybe included if they are confirmed to be the final CBC before discharge and the patient had a non-hematological diagnosis

Exclusion Criteria:

* Samples originating from a hematology/oncology clinic (both inpatient and outpatient)
* Samples originating from a patient with a hematological disorder or diagnosis
* Samples from the Neonatal Intensive Care Unit that are not the last specimens collected prior to discharge
Pre-Surgery Positron Emission Mammography in Patients With Newly Diagnosed Breast Cancer

The purpose of the study is to determine the optimal, lowest dose of radioactive tracer required for Positron Emission Mammography (PEM), and the accuracy and reliability of PEM in pre-surgical evaluations for patients with newly diagnosed breast cancer anticipating breast-conserving surgery but identified to have a second unsuspected breast cancer by MRI.

The purpose of this research in Phase 1 is to determine the lowest dose of radionuclide 18F-FDG that can be used in the Diagnostic use of Positron Emission Mammography for the diagnosis of multifocal breast cancer in patients wishing to have Breast Conservation Surgery for newly diagnosed breast cancer. Low dose injections (radioactive counts) of 18F-FDG will be compared to the equivalent radioactive counts for the standard higher dose 10 millicuries used in standard PEM studies in current clinical practice. Images will be post processed by computer aided software and will be placed in two categories: Low dose group, and higher dose group. Images will be randomly blinded to readers to assess the ability to see positive lesions that warrant further biopsy or to include in current surgical planning prior to breast conservation surgery or mastectomy. Images will be assessed for ability to see the PEM positive lesions on the lower dose images and this will be compared to the ability to see the PEM positive lesions on the standard higher dose images. Each of three breast cancer categories will be assessed Infiltrating Ductal Carcinoma, Lobular infiltrating Carcinoma, and Ductal Carcinoma Insitu. Phase 1 will have 30 patients.

The purpose of the research in Phase 2 is to use the lowest dose identified in Phase 1 for imaging primary breast cancer patients who have been identified by breast MRI to have an unsuspected second lesion of the breast not expected from Mammography or Ultrasound that requires biopsy for diagnosis prior to the biopsy to compare the reliability of PEM and MRI for identifying breast cancer at the 2nd site. Parameters assessed will include standard statistical analysis for sensitivity, specificity, positive predictive value and negative predictive value for MRI and PEM imaging with the new lower radionuclide dose selected by Phase 1. Phase 2 will have 100 patients.

Eligibility Criteria:
Inclusion Criteria:

* Must be 18 years of age or older
* Newly diagnosed primary breast cancer
* Must have a breast or breast/chest MRI ordered as part of standard of care
* Must meet one or more of the following in Part 1:

  * T1 carcinoma of the breast appropriate for breast conserving surgery diagnosis established by core biopsy
  * Tis (ductal carcinoma in situ) carcinoma \> 2 cm diameter
  * Invasive lobular carcinoma of the breast
* Must meet the following in Part 2:

  * Known invasive or in situ primary breast cancer identified on pre-surgical breast MRI to have an unsuspected 2nd lesion recommended for biopsy and biopsy has not yet been performed

Exclusion Criteria:

* Known diabetes mellitus
Subcutaneous Daptomycin in Healthy Volunteers (DAPTOSC)

Background:

Multidrug-resistant bacteria are a major public health problem worldwide, notably due to excess mortality and an increase in the length of hospital stay. Antibiotics that can be used to treat these infections are limited. Daptomycin is one of the most widely used antibiotics for the treatment of infections with gram-positive bacteria, such as methicillin-resistant Staphylococcus aureus (MRSA). However, it is only administered intravenously (IV). It is therefore interesting to find new routes of administration in order to widen the possibilities of using daptomycin, especially in people who have difficulties with the venous approach.

Methods/design:

In a randomized, single blinded, crossover, noninferiority study in the CHU of Caen, the investigators aim to demonstrate the pharmacokinetic bioequivalence between the subcutaneous and the intravenous route of daptomycin in healthy volunteers. They will conclude the bioequivalence if the confidence interval of the area under the curve obtained is entirely within the interval \[80% - 125%\].

Discussion:

This clinical trial could, if bioequivalence is demonstrated, lead to the completion of a clinical trial in infected patients in order to assess the efficacy and safety of daptomycin by the subcutaneous route.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteer from 18 to 65 years old
* Subject determined in good health by a doctor
* Signature of free and informed consent
* Affiliated to the French healthcare insurance
* Fluent in French

Exclusion Criteria:

* Active bacterial or viral infection
* Immunocompromised
* Body mass index \<20 or\> 30 kg / m2
* Kidney failure with glomerular filtration rate \<90ml / min / m2 calculated according to the CKD-EPI method
* Known or suspected liver disease
* Pregnant or lactating woman
* Guardianship or curators
* Any situation that could interfere with the self / hetero assessment of pain (dementia, psychiatric disorders, for example)
* Concomitant intake of myotoxic drugs (statins, fibrates, ciclosporin, for example)
* Allergy or known side effects to daptomycin
* Dermatological pathologies which may interfere with the subcutaneous injection (eczema, psoriasis, etc.)
* Localized tattoo or piercing on the abdomen which may interfere with the subcutaneous injection or the evaluation of possible local effects of the injection
* Parenteral exposure to daptomycin in the previous 30 days
* The inclusion of the subject in another interventional research protocol (during the present study and in the 3 months before inclusion).