cyrilzakka/clinical-trials huggingface dataset:
Active Lifestyle Intervention in Anorexia Nervosa: a Comprehensive Study

The goal of this study is to perform a comprehensive analysis of varied health markers and analyze the impact of lifestyle interventions on the prognosis of anorexia nervosa (AN) patients. In addition, this study aims to determine if biomarker analysis can be used as clinical outcomes for disease prognosis long-term and support individualized treatment strategies in female patients with AN during the post-hospitalization phase.

The main questions it aims to answer are:

* What are the miRs and microbiota profiles associated with AN, and how are they linked to other clinical markers?
* How does a lifestyle intervention (exercise with nutritional support) affect biomarkers and clinical markers during the first three months after hospitalization?
* What are the dynamics and associations of biomarkers, including gut microbiota, and how do they relate to critical events during the six months after hospitalization?
* What is the perceived effect of participating in a healthy lifestyle program for patients, families, and professionals involved in the care of these patients?

Participants will:

* Undergo analysis of biomarkers and gut microbiota associated with AN.
* Participate in a lifestyle intervention program involving exercise during the first three months post-hospitalization.
* Provide samples for biomarker and gut microbiota mapping over a six-month period.
* Share feedback on their perceived experience in the lifestyle program through interviews or surveys.

Researchers will compare biomarker and gut microbiota and the effects of the intervention to determine if a lifestyle exercise intervention can lead to better outcomes, and analyze its potential to individualized care strategies.


Eligibility Criteria:
Inclusion Criteria:

A) Patients:

* Patients with a diagnosis of AN (any subtype)
* BMI \>14kg/m2
* Under treatment at the Regional Eating Disorders Unit at the Area IV and V of the Principality of Asturias
* After acute treatment (total or partial hospitalization or other acute treatment regime following the recommendation of the medical team)

B) Healthy Controls:

- Meet the physical activity recommendations of the World Health Organization for the age group and sex.

Exclusion Criteria:

A) Patients:

* Contraindications to perform the evaluations proposed in this project
* Unmanaged dysfunctional or compulsive exercise
* Other criteria that, in the opinion of the medical team, prioritize the patient's health (i.e., psychological instability, substance abuse) .

B) Healthy Controls:

* Suffer from metabolic, pulmonary or cardiovascular disease
* Suffer from serious organic disease
* Taking prescribed medications while participating in the project
* Have contraindications to perform the proposed assessments or intervention.
Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of BIIB033 in Healthy Japanese Participants

The primary objective of this study is to assess the safety and tolerability of a single dose and multiple doses of BIIB033 administered to healthy adult Japanese participants. The secondary objectives of this study are to evaluate the pharmacokinetics (PK) profile of BIIB033 administered as single and multiple doses in healthy adult Japanese participants and to assess the single-dose and multiple-dose immunogenicity of BIIB033.


Eligibility Criteria:
Key Inclusion Criteria:

* Japanese subjects must have been born in Japan, and their biological parents and grandparents must all have been of Japanese origin.
* Subjects who have lived out of Japan for more than 5 years must not have significantly modified their diets since leaving Japan.
* Must be a nonsmoker or light smoker (\<10 cigarettes per day) and be willing to abstain from using tobacco and tobacco-containing products during the Inpatient Period and for at least 48 hours prior to Day -1, Day 14 (for Cohort 3), and all outpatient visits.
* Must have a body mass index of 18 to 32 kg/m2, inclusive.

Key Exclusion Criteria:

* History of any clinically significant cardiac, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major disease, as determined by the Investigator.
* Serious infection (e.g., pneumonia, septicemia) as determined by the Investigator within the 3 months prior to Day -1.
* Fever or bacterial or viral infection (including upper respiratory tract infection) within 2 weeks prior to Day -1.
* History of severe allergic or anaphylactic reactions.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Biomarker Signature and Musculoskeletal Ultrasound Profile in Rheumatoid Arthritis Patients

The purpose of this study is to determine the kinetics of change in quantitative measures of joint inflammation by state of the art power Doppler vascular imaging and to identify biomarkers in biological samples (synovial biopsies, DNA, RNA, PBMC, serum, plasma, urine and stool samples) from parallel cohorts of RA patients undergoing different treatments. This will be achieved implementing MSUS assessments, standard laboratories techniques (such as ELISAs, gene profiling, transcriptome analysis etc.) and the novel CyTOF™ technology.


Eligibility Criteria:
Inclusion Criteria:

* Written confirmed diagnosis of Rheumatoid Arthritis as per ACR/EULAR 2010 criteria.
* If patient is on oral corticosteroids, dose must be stable for 6 weeks prior to baseline visit.
* Willingness and ability to comply with all the study procedures.

Exclusion Criteria:

* Any systemic inflammation conditions (other than RA), connective tissue disease or chronic pain disorders that may interfere with the interpretation of the outcome data. Examples include psoriatic arthritis, reactive arthritis, gout, systemic lupus erythematosus (SLE), polymyalgia rheumatic and/or temporal arteritis, Lyme's disease, fibromyalgia and chronic fatigue syndromes.
* Major surgery planned within 8 weeks prior to screening or planned surgery throughout the study period.
* Treatment with any investigational agent ≤ 4 weeks prior to baseline (or 5 ≤ half-lives of the investigational drug, whichever is the longer).
* Intramuscular/intra-articular glucocorticoids for 6 weeks prior to baseline visit.
* Active infection.
* Septic arthritis within a native joint within the last 12 months.
* Sepsis of a prosthetic joint within 12 months or indefinitely if the joint remains in situ.
* Known HIV or hepatitis B/C infection.
* Latent TB infection unless they have completed adequate antibiotic prophylaxis.
* Malignancy (other than basal cell carcinoma) within the last 10 years.
* New York Heart Association (NYHA) grade 3 or 4 congestive cardiac failure.
* Demyelinating disease.
* Presence of a transplanted organ (with the exception of a corneal transplant \> 3 months prior to screening).
* Known recent substance abuse (drug or alcohol).
Field Test of Motivity.Net Software for Data Collection During Behavioral Interventions

This is a study funded by a Phase II SBIR to build and test the feasibility of a new software prototype for delivering evidence-based behavioral therapy treatment for autism. The software, called Motivity.net, will be used by behavioral therapy provider groups across the country to manage the intensive data collection and analysis workflow associated with Applied Behavioral Analysis (ABA) and related therapies, which are becoming standard-of-care treatment for children with autism.

This is a study funded by a Phase II SBIR to build and test the feasibility of a new software prototype for delivering evidence-based behavioral therapy treatment for autism. The software, called Motivity.net, will be used by behavioral therapy provider groups across the country to manage the intensive data collection and analysis workflow associated with Applied Behavioral Analysis (ABA) and related therapies, which are becoming standard-of-care treatment for children with autism. Experiad will conduct an 8-week within-subject pilot study of 6 BCBAs, 12 BTs and 12 children to answer product research questions about Motivity's ability to perform its intended functions, measuring the degree to which it allows interventionists to encode their models, achieve more efficient program management, improve communication, and increase responsiveness to a child's progress. Experiad will also use descriptive statistics to provide preliminary insight into the potential impact of the system on a child's performance in their ABA therapy.

Eligibility Criteria:
Inclusion Criteria:

* Child receiving applied behavior analysis at participating institution to treat autism disorder

Exclusion Criteria:

* None
Optimizing Treatment Effects on OSA-related Clinical and Patient-centered Outcomes Among Blacks

The study is to maximize efficacy of message delivery to achieve desired Obstructive sleep apnea (OSA) adherence goal. Newly diagnosed black patients (n=390, all genders) from participating sleep clinics will be randomly exposed to either the individually tailored or standard OSA messages. Investigators will look at an effective and scalable intervention to improve OSA-related outcomes: a) clinical CVD and brain health measures and b) patient-centered outcomes. Patient-centered and adherence data will be captured via REDCap, enabling real-time application of data-driven decision rules while implementing the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Self-reported race/ethnicity as African American, African, Caribbean or black
* Accessible by phone
* No plans to move away within the year
* OSA diagnosis, consent, including permission to release medical data
* Physician-diagnosed medical conditions.

Exclusion Criteria:

* Progressive illnesses in which disability or death is expected within 1 year
* Impaired cognitive/ functional ability precluding participation
* Intention to move within the same year of enrollment
* Family member currently enrolled
Effect of SMS Use on Postoperative Respiratory and Cough Exercise Compliance

Aim: This randomized controlled trial study aimed to evaluate the effect of SMS use on compliance with postoperative breathing and coughing exercises and patient satisfaction in patients undergoing pulmonary lobectomy for lung cancer surgery.

Material and methods: In the study, 62 patients who underwent lobectomy in a university hospital's thoracic surgery clinic between 01.02.2022 and 03.04.2023. The intervention group was chosen to be the group that received SMS messages.

Background: Patients undergoing lung resection should be encouraged to cough, take deep breaths for pulmonary rehabilitation within the scope of enhanced recovery after surgery protocols. The success of protocols is related to patient compliance. SMS-based interventions increase compliance with medications and protocols in surgical patients and reduce hospital readmission rates, while improving patients' clinical participation and satisfaction.

Aim: This randomized controlled trial study aimed to evaluate the effect of SMS use on compliance with postoperative breathing and coughing exercises and patient satisfaction in patients undergoing pulmonary lobectomy for lung cancer surgery.

Material and methods: In the study, 62 patients who underwent lobectomy in a university hospital's thoracic surgery clinic between 01.02.2022 and 03.04.2023. The intervention group was chosen to be the group that received SMS messages.

"The Information Form", "Postoperative exercise follow-up chart", "Postoperative patient evaluation form" and "Patient satisfaction form were used in data collection. Independent sample t-test, Pearson chi- square and Mann Whitney U test were conducted for statistical analyses.

Eligibility Criteria:
Inclusion Criteria:

* undergoing elective pulmonary lobectomy,
* having preoperative normal lung capacity (pulmonary function test result FEV1/FVC \>70%),
* being compatible with the use of triflow, undergoing pulmonary lobectomy for the first time,
* volunteering to participate in the study,
* having mental competence,
* not having Turkish communication problems,
* having a personal mobile phone and accepting to send SMS,
* being an adult (≥18)

Exclusion Criteria:

* If any SMSs are not received during the study period, the patient will be excluded from the study.
Impact of the Use of Ketamine in Laparoscopic Surgery.

In order to improve the postoperative period (namely pain control), several drugs can be used. For instance, ketamine is a general anesthetic that holds strong analgesic properties, yet also owns undesirable effects, in which hallucination phenomena is one the most common indicator. However, slight information is available about the real implication in the quality of the recovery on the use of ketamine for postoperative pain treatment. The quality of the recovery includes several health conditions, such as pain, physical comfort, physical independence, psychological support and emotional state. In recent years, investigations in this field has been attracted the attention by the health professionals, since is an indicator of the quality of post-operative care. To evaluate these parameters, questionnaires have been developed, in which the Portuguese version of Quality of Recovery 15 (QoR-15) is include. This questionnaire evaluates five psychometric dimensions. Therefore, the present study has the main goal, the evaluation of the effect of using ketamine in laparoscopic surgery and the quality of the recovery using the QoR-15 questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* Patients between 18 and 65 years age, with an American Society of Anesthesiology physical status I, II or III.
* Laparoscopic surgery (sleeve gastrectomy, salpingectomy, or cholecystectomy)

Exclusion Criteria:

* patient refusal, the incapacity of providing informed consent, drug abusers (current or past history) or alcohol abuse, medication with benzodiazepines, inability to give informed consent, pregnant, emergency surgery, psychiatric pathology, existence of surgical complications in the recovery and admission to a level II or III unit ( for any reason).
Intensity-Modulated Radiation Therapy in Treating Patients With Stage I, Stage II, Stage III, or Stage IV Prostate Cancer

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Using scintigraphy to plan specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.

PURPOSE: This phase I/II trial is studying the side effects and best way to give intensity-modulated radiation therapy and to see how well it works in treating patients with stage I, stage II, stage III, or stage IV prostate cancer.

OBJECTIVES:

* To assess the feasibility of radioimmunoguided intensity-modulated radiotherapy (IMRT) for stage I-IV prostate cancer.
* To determine the toxicity and tolerance of this regimen in these patients.
* To determine the tumor response based on physical examination and serial measurements of the serum prostate-specific antigen (PSA) levels in these patients.
* To determine the outcome of patients treated on this study with radioimmunoguided IMRT compared to 2 control groups of patients treated at Mayo Scottsdale Clinic (MSC).

OUTLINE: Patients undergo radioimmunoguided intensity-modulated radiotherapy once daily, 5 days a week for 8½ weeks. Beginning the last week of radiotherapy, some patients receive leuprolide acetate intramuscularly every 3-4 months or goserelin subcutaneously every 3 months for 6 months, 12 months, or until disease progression.

After completion of study treatment, patients are followed every 3-4 months for 1 year, every 6 months for 4 years and annually thereafter

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Pathologically confirmed prostate cancer

  * Stage I-IV disease (T1-4, N0-1, M0)
* No evidence of distant metastases (M0) on physical examination or bone scan

PATIENT CHARACTERISTICS:

* ECOG performance status 0-2
* Hemoglobin ≥ 10.0 g/dL
* WBC ≥ 3,000/mcL
* Platelet count ≥ 90,000/mm
* AST \< 2 times the upper limit of normal
* No allergy to leuprolide acetate or goserelin

PRIOR CONCURRENT THERAPY:

* Not specified
Measurement of Retinal Venous Pressure in Chronic Low-oxygen Environment

The hypothesis is that the pressure in the retinal veins increases from chronic lack of oxygen and leads to decreased blood flow. On the basis of high altitude mountaineering this hypothesis should be verified. At the same time the adaptation capacity of the blood circulation should be analyzed, and a relationship to mountain sickness should be found.

Conduct a field study to describe and quantify the retinal venous pressure (RVP) in healthy volunteers under conditions of controlled chronically reduced ambient pressure and oxygen partial pressure in the mountains. Obtaining indications regarding the adaptation of the retinal vascular system behavior to controlled, long-term hypoxic changes. Comparisons with blood pressure, pulse, oxygen saturation level and the appearance of symptoms of acute mountain sickness are made in order to obtain a better understanding of the development of high altitude illness.

Eligibility Criteria:
Inclusion Criteria:

* healthy

Exclusion Criteria:

* eye diseases
* systemic diseases
* term medication (except contraceptives)
* pregnancy
* allergies to the ingredients Alcain, Tropicamide and Phenylephrine
Effect of Posterior Corneal Toricity on Refractive Outcome of Pseudophakia

This study is to evaluate the necessity of considering posterior corneal toricity on refractive outcome of patients with cataracts and corneal astigmatism after implantation of intraocular lenses.

This is determined by comparing total corneal and refractive astigmatism,and by comparing the expected refractive result with actual refractive astigmatism postoperatively,using total corneal and anterior corneal astigmatism to calculate respectively.


Eligibility Criteria:
Inclusion Criteria:

* cataract candidates
* preoperative corneal regular astigmatism \>0.75D
* Willing and able to complete all required postoperative visits
* Able to comprehend and sign a statement of informed consent

Exclusion Criteria:

* significant intraocular lenses tilt or decentration
* corneal scarring
* Irregular corneal astigmatism
* other ocular diseases
* surgical complication
Cerebral Vascular Reserve in Small Vessel Disease and Alzheimers Disease

Alzheimers disease and cerebral small vessel disease have a considerably overlap in patients and have common risk factors. The diseases are difficult to separate in individual patients and we hypothesize that a reduced cerebral vascular reserve may be a measurement of small vessel disease independent of Alzheimers disease.

Patients with presumed Alzheimers disease (n=20), cerebral small vessel disease (n=20) and healthy age-matched subjects (n=15) are examined with quantitative \[15O\]H2O positron emission tomography (PET) for measurements of brain perfusion before and after diamox infusion that dilates cerebral vessels. Additional \[15O\]H2O PET scans of the heart allows for a non-invasive input function so the cerebral vascular reserve can be measured quantitatively.

Alzheimers disease and cerebral small vessel disease are increasingly common in the elderly population and constitute around 90% of new dementia cases in Denmark. The diseases have a considerably overlap in patients and have common risk factors. The cause of dementia can be difficult to separate in individual patients but a reduced cerebral vascular reserve may be a measurement of small vessel disease independent of Alzheimers disease. We hypothesized that patient with small vessel disease have reduced increase in brain perfusion after medical brain vessel dilatation. While Alzheimer patients may have reduced perfusion in rest but normal increase after medical brain vessel dilatation as compared to healthy subjects.

Patients with presumed Alzheimers disease (n=20), cerebral small vessel disease (n=20) and healthy age-matched subjects (n=15) are examined with quantitative \[15O\]H2O PET for measurements of brain perfusion before and after diamox infusion that dilates cerebral vessels. Additional \[15O\]H2O PET scans of the heart allows for a non-invasive input function so the cerebral vascular reserve can be measured quantitatively.

Eligibility Criteria:
Inclusion Criteria:

* presumed Alzheimer's Disease (group 1)
* diagnosed with small vessel disease of the brain by MRI and presumed cognitive dysfunction (group 2)

Exclusion Criteria:

* major claustrophobia
* major psychiatric diseases
* other major somatic diseases
* allergy to diamox
Comparing the Clinical Outcomes of DermACELL® With Integra® Bilayer Wound Matrix

Both DermACELL® and Integra® Bilayer Wound Matrix are indicated for deep soft tissue coverage and serve as a biological matrix for cellular migration. The current thinking about the utility of these products is to apply over the wound surface and wait until the graft is well vascularized (granular bed/neodermis). At that point a split thickness skin graft can be applied over this area to cover and heal the wound. This study will determine whether human allograft or xenograft will create a durable neodermis that is more supportive of accepting of a split thickness skin graft. Patients who do not receive Split thickness skin grafts will be assigned to the second cohort for observation of healing rates.

This is a prospective, randomized, single site, clinical research trial comparing the clinical outcomes of DermACELL® compared with Integra® Bilayer Wound Matrix in dermal regeneration. A total of 100 subjects will be randomized into either the DermACELL® (n=50) or Integra® Bilayer Wound Matrix (n=50) treatment group. An interim analysis will be performed when both groups have enrolled 25 subjects. Subjects will receive either DermACELL® or Integra® Bilayer Wound Matrix in the operating room for coverage of deep soft tissue defects in the lower extremity. Subjects will then be followed in the outpatient clinic. Once the neodermis has been sufficiently generated, a split thickness skin graft (autograft or allograft) will be applied in the operating room. The split thickness skin graft application site will be then followed to observe viability.

Eligibility Criteria:
Inclusion Criteria:

1. male or female 18-90
2. who have a complex soft tissue defect that extends below subcutaneous tissue (exposed fascia, ligament, tendon, muscle, or bone)
3. wounds that are either acute or chronic (nonhealing wounds greater than 4 weeks but not greater than 2 years in duration)
4. wounds not amendable to primary closure as deemed by the surgeon
5. wounds that have been deemed by the surgeon that any residual infection has been or is being treated upon entry into the clinical trial
6. requiring operative application of a dermoconductive agent
7. extremity wounds have adequate perfusion determined by: palpable pedal pulses, dopplerable pulses, ankle brachial index of \>0.7, or transcutaneous oximetry of \>0.5
8. renally stable (i.e. CR\<3.0, BUN\>9.0, eGFR \>60)
9. is able to comply to clinical trial requirements

Exclusion Criteria:

1. with a contraindication for the application of a xenograft or allograft
2. untreated infection of soft tissue or bone
3. untreated autoimmune connective tissue disorders
4. body mass index of ≥ 50
5. undergoing chemotherapy/radiation therapy
6. malignancy
7. active liver disease (e.g. hepatitis A-G),
8. previous wound care therapy that included any bioengineered alternative tissue or STSG 30 days prior to enrollment
9. pregnancy
10. enrolled in any other interventional clinical research trial
11. unable or unwilling to comply with study requirements