cyrilzakka/clinical-trials huggingface dataset:
The Effectiveness of 3DVR Horticultural Therapy on Older Adults

This study intends to develop a 3DVR-based horticultural therapy intervention to explore the health effectiveness among older adults

Background: Institutionalized older adults have limited ability to engage in horticultural activities that can promote their physical and mental health.

Objective: This study explored the effects of a combination of three-dimensional (3D) virtual reality (VR) and horticultural therapy (HT) on institutionalized older adults' physical and mental health.

Methods: The study applied a quasi-experimental design. A total of 106 older adults from two long-term care facilities were recruited and assigned to the experimental (n = 59) or control (n = 47) group. The experimental participants received a nine-week intervention. Both groups completed three assessments: at baseline, after the intervention, and two months later. The outcome variables included health status, meaning in life, perceived mattering, loneliness, and depression.

Eligibility Criteria:
Inclusion Criteria:

* over 65 years old.
* being a long-term resident of the selected LTCF
* possessing the ability to understand verbal meanings
* being able to freely operate a joystick.

Exclusion Criteria:

* a history of severe psychiatric conditions, dementia, significant visual or hearing impairment, and/or current severe illnesses such as stroke or Parkinson's disease.
Amount of Lactose Causing Symptoms in Lactose Intolerant People

The hypothesis underlying this study is that failure to recognise the role of lactose intolerance among patients has led to inappropriate dietary advice and treatment with drugs that contain lactose as a filler. These failures exacerbate symptoms and lead to the unnecessary use of immune suppressant drugs.

This study will identify the threshold at which symptoms of lactose intolerance develop, to provide appropriate advice and treatment in the management of patients.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed lactose intolerance demonstrated with a lactose intolerance test.
* Adherence to a lactose free diet for at least four days before the start of the study.

Exclusion Criteria:

* Failure to adhere to a lactose free diet.
* People who are on lactose containing medications.
* Pregnancy.
* Unwillingness to comply with study outline.
Effects of Immune Checkpoint Inhibitors on Coronary Microvasculature

This is an observational study that includes patients with breast cancer or non-small cell lung cancer who will be treated with immune checkpoint inhibitor (ICI) therapy. The investigators will use echocardiograms, blood draws, and PET stress tests to understand how ICI therapy affects the heart and circulatory system.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age
* Either diagnosis of breast cancer with plan for treatment according to the Keynote 522 regimen or non-small-cell lung cancer planned for neoadjuvant treatment that includes pembrolizumab
* Able to provide written informed consent

Exclusion Criteria:

* Pregnant or breast-feeding:
* Prior treatment with ICI therapy.
* Vulnerable patients, including pregnant women and prisoners
* Absolute Contraindication to rest/vasodilator stress PET/CT
Evaluation of a Daily Brief Exercise Intervention on Resident Physician Personal Resiliency and Burnout

This study seeks to evaluate the prevalence and characterize predictors of physician burnout in the anesthesia residency at Vanderbilt University Medical Center. The study also seeks to evaluate the effect of an exercise intervention on burnout and personal resiliency (i.e., less individual stress given the same workload).

A cross-sectional evaluation of burnout, perceived stress, average sleep propensity, and social support and coping mechanisms will be assessed from four years of Vanderbilt University Medical Center (VUMC) Anesthesia residents. Burnout will be assessed using the Maslach Burnout Inventory (MBI-HSS).

Participating interns, Anesthesia Residency Class 1 (CA-1), and Anesthesia Residency Class 2 (CA-2) classes will be randomized to 8 weeks of an exercise intervention (15 min of activity at 70% of max heart rate or higher, 5 days a week) to meet the activity recommendations of the Office of Disease Prevention and Health Promotion or 8 weeks of continuing their baseline activity level prior to the study.

Eligibility Criteria:
Inclusion Criteria:

* Vanderbilt University Medical Center Anesthesiology residents (Class 1(CA-1), Class 2 (CA-2)

Exclusion Criteria:

* Failure to sign informed consent
* Will not be in town and available for the full duration of the study (e.g., 2 or more weeks of vacation or absence)
* Physical inability to perform the exercise intervention (including health indications)
The C-MIC-II Follow-Up Study

The C-MIC System is a medical device used to treat heart failure per the intended purpose which is to treat heart failure by applying an electrical micro-current to the heart.

Target patients for this study are patients who have received the device in a prior study.

The C-MIC System is a medical device used to treat heart failure per the intended purpose which is to treat heart failure by applying an electrical micro-current to the heart. The therapy with the C-MIC System is intended to take 6 months.

The C-MIC System consists of four parts, of which three are implanted: a transvenous and an epicardial lead and a power source to which the leads are connected. Both leads have the function to transmit micro-current to the heart. A Portable User Terminal (PUT) is needed for programming and readout of the data recorded by the Implantable Microcurrent Device (IMD).

Target patients of the C-MIC System at the time of implantation and inclusion in the C-MICII Study were patients with idiopathic dilative cardiomyopathy (NYHA class III - NYHA class who have systolic left ventricular dysfunction despite adequate therapy of heart failure.

Target patients for this study are patients who have received the device in a prior study.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have received a C-MIC System during the C-MIC-II Study.
* Informed consent in writing from the patient.

Exclusion Criteria:

* Patients who are unwilling or unable to participate in the study visits.
* Vulnerable Patients.
Efficacy and Safety of AIN457 (Secukinumab) in Patients With Relapsing Multiple Sclerosis

To evaluate the efficacy and safety of AIN457 versus placebo in patients with relapsing multiple sclerosis.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Multiple Sclerosis according to 2010 revised McDonald criteria
* Disease duration of 10 years or less
* At least one relapse in the last year
* EDSS score 0 to 5.0 at entry

Exclusion Criteria:

* Active chronic disease of the immune system other than multiple sclerosis
* History of malignancy within the past 5 years
* Active systemic bacterial, viral or fungal infections
* Previous treatment with more than one class of multiple sclerosis therapies except for previous treatment with glatiramer acetate and interferon-beta(s)
* Any medically unstable condition
* Unable to undergo MRI scans or repeated blood tests
* Pregnant or nursing females
* Women of child-bearing potential must use reliable forms of contraception
* Other protocol-defined inclusion/exclusion criteria may apply.
Predictors of Chronic Non-specific Low Back Pain

Chronic non-specific low back pain (CNSLBP) has been defined as a persistent pain in the lower back for at least three months with no known causes. The CNSLBP prevalence is estimated of 90% among all types of the LBP. The LBP imposes high direct and indirect costs on the patients and the society. Whereas a specific pathology has not been identified for CNSLBP, mechanical factors (e.g. changes in muscle length, strength, or endurance) may contribute to the pain and disability.


Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic non-specific LBP,
* LBP duration ≥ 6 months.

Exclusion Criteria:

* spinal osteoarthritis,
* spondylolisthesis,
* history of vertebral fractures.
Comparison of the Increment of Neuromuscular Parameters in Vegetarians and Non-vegetarians

A strength training session promotes increased muscle sensitivity to protein synthesis, which lasts for 24 hours after its closure. Recent studies have shown that the subsequent intake to the training session of approximately 20g or 0.24g / kg of high-quality protein in the same meal induces a plateau in this synthesis. Thus, this study aims to compare the muscular strength between vegetarian and omnivorous athletes with adequate protein intake to reach this plateau. It will recruit 64 university sportsmen who have maintained vegetarian or omnivorous diet for at least 6 months, totalizing 32 individuals per group. After signing the Term of Consent, participants will be submitted to anthropometric and body composition assessment (via DEXA), neuromuscular tests \[(ie, muscle strength - 1RM, peak torque of knee extensors (JE), muscle thickness of JE and cohort analysis (ANCOVA) will be used in order to compare the results of the study, and to compare the results of the covariance analysis (ANCOVA). the levels of the neuromuscular parameters between the groups, considering the initial values of the force and the initial muscular thickness as covariables, the other parameters will be presented in the form of mean and standard deviation or median, the differences will be considered significant for values of p \<0, 05. Expected to find no differences in strength and muscle thickness between vegetarians and omnivores after adequate protein intake.


Eligibility Criteria:
Inclusion Criteria:

* Be over the age of 19 and under 60;
* Have BMI \<30 kg / m²;
* Be vegetarian or omnivorous for at least 6 months;
* Have not exercised regularly for at least 6 months.
* Be available to practice bodybuilding at School of Physical Education, Physiotherapy and Dance, 2x / week, for 3 months, free (times to combine).

Exclusion Criteria

* Be vegan, vegetarian lacto or vegetarian egg
* Be a carrier of chronic diseases;
* Present physical limitations or musculoskeletal problems, which contraindicate the performance of strength exercises;
* Failure to adhere to the proposed dietary modifications, relating to the adequacy of the portion of protein per meal, due to financial unfeasibility (low income condition);
* Use of protein or amino acid, caffeine or other thermogenic food supplements.
Retrospective Evaluation of Clinical and Radiographic Outcomes Following Total Talus Replacement

This study is a retrospective analysis of patients who underwent surgery using a total talus replacement (TTR) implant with or without concurrent total ankle replacement and/or subtalar fusion. This study seeks to analyze the clinical and radiographic outcomes of TTR implant recipients and generate additional data on the safety and benefit of the TTR implant.


Eligibility Criteria:
Inclusion Criteria:

* \>18 Years of Age
* Patient underwent surgery involving a total talus replacement implant between 1/1/2019 and 01/28/2022.

Exclusion Criteria:

* No available postoperative data
Eating Disorders Genetics Initiative 2

The overarching intention of the Eating Disorder Genetics Initiative 2 (EDGI2) is to increase sample size, diversity, and eating disorder phenotypes. The investigators are enrolling 20,000 new participants with anorexia nervosa (AN), bulimia nervosa (BN), binge-eating disorder (BED), avoidant/restrictive food intake disorder (ARFID), and controls in the US, Mexico, Australia, New Zealand, Sweden, and Denmark. A primary study goal is to enroll at least 30% of participants from underrepresented groups. Participants are asked to complete a series of questionnaires and submit a saliva sample for genotyping. The goal is to better understand eating disorders and how they relate to each other so that better treatments can be developed.


Eligibility Criteria:
Inclusion Criteria:

* A lifetime history of anorexia nervosa, bulimia nervosa, binge-eating disorder, avoidant restrictive food intake disorders or no history of any disordered eating behavior, based on DSM-5 criteria algorithms
* Age 12-99 years, depending on country. (US enrollment age is 18-99)

Exclusion Criteria:

* History of subthreshold disordered eating behaviors.
The Effect of Tai Chi in Treating Fibromyalgia

To evaluate the effect of Tai chi on Fibromyalgia


Eligibility Criteria:
Inclusion Criteria:

* 40 years of age or older
* meeting the classification of FM per the 1990 ACR criteria
* approval by a healthcare provider for participation

Exclusion Criteria:

* had practiced Tai chi within the past 6 months
* had exercised \>30 min three times weekly for past 3 months
* could not independently ambulate without assistive devices
* had BPI pain severity or interference scores less than 5
* had planned elective surgery during study period
* were actively involved in health-related litigation
* were unwilling to keep all treatments/medications steady throughout the study period
Left Atrial Ablation With Permanent Pacemaker or ImplanTable Loop Recorder Follow-UP

The purpose of this study is 3 fold:-

1. To compare the efficacy and complication rates of 2 widely used methods, conventional irrigation tip ablation catheter (LASSO) and Ablation Frontiers ablation technology, of AF ablation for PAF.
2. To evaluate the Reveal XT ILR as a long term accurate AF monitoring device as compared to the 'gold standard' DDD pacemaker Holter.
3. To accurately evaluate, by continuous rhythm monitoring for 1 year, the efficacy of AF ablation therapy for PAF.


Eligibility Criteria:
Inclusion Criteria:

* Patient aged 16-80 years old.
* Symptomatic PAF with AF episodes self terminating after at least 30 seconds but not longer than 24 hours. Preference is given to patients with AF episodes lasting no longer than 4 hours.
* PAF should have failed at least one drug therapy medical therapy.
* Patients must give written informed consent form prior to participating in this study.

Exclusion Criteria:

* Patient is suffering with unstable angina in last 1 week.
* Patient has had a myocardial infarction within last 2 months.
* Patient is expecting or has had major cardiac surgery within last 2 months.
* Patient is participating in a conflicting study.
* Patient is mentally incapacitated and cannot consent or comply with follow-up.
* Patient has NYHA class III/ IV heart failure.
* Patients with severe valvular or ventricular dysfunction.
* Pregnancy.
* Patient suffers with other cardiac rhythm disorders.
* Recent coronary artery intervention or other factors suggesting clinical instability (ECG, clinical or laboratory findings)
A National Screening Program for Islet Autoantibodies Among First-degree Relatives of T1D Patients

A national Screening program for the presence of Islet Autoantibodies (IA) in relatives of people with type 1 diabetes (PWT1D) aiming at identifying people with pre-clinical (stage 1 \& 2) T1D and DKA prevention on the clinical presentation of T1D. All participants will be screened at study entry for the presence of 4 islet autoantibodies: glutamic acid decarboxylase antibody (GADA), insulinoma-associated-2 antibody (IA-2A), insulin antibodies (IAA) and Zinc transporter-8 antibodies (ZnT8A). The ADAP assay will be used to detect IA.

A confirmation blood sample for positive participants with two or more IA will be taken. The confirmation analysis will be done by the ADAP assay, conventional ELISA, and RIA.

Participants identified as part of the study with pre-symptomatic type 1 diabetes (T1D) (stages 1 and 2) will be referred to complete an educational program emphasizing DKA prevention as part of routine medical care .During the study, cases of stage 2 and stage 3 diabetes and DKA events in participants who are positive for IA will be documented.


Eligibility Criteria:
Inclusion Criteria:

* Age 2-45 years
* First-degree relatives of Type 1 Diabetes probands
* Signing an informed consent

Exclusion Criteria:

* Known diabetes of any kind (type 1, type 2, MODY)
* Have a previous history of being treated with insulin or oral diabetes medications.
* Currently, using systemic immunosuppressive agents (topical and inhaled agents are acceptable)
2-D and 3-D Laparoscopic Hysterectomy

Background:

No randomised trials have been conducted, and only a single retrospective study exists comparing 3D and 2D laparoscopic hysterectomy. In that study, operative time for hysterectomy was significantly lower for 3D compared to 2D conventional laparoscopy. Complication rates were similar for the two groups. Thus, although one out of nine women is hysterectomized and although laparoscopy is one of the recommended routes of surgery, evidence whether to choose 2D laparoscopy, 3D laparoscopy is sparse.

Objective:

To compare pain and recurrence to usual activity level. Secondary to compare complications during the operation, postoperative complications, time to return to work, length of hospital stay and operative time.

Design:

Investigator-initiated, blinded, randomised controlled trial.

Intervention description:

Operative procedures follow the same principles and the same standard whether the surgeon's vision is 2D or 3D.

Trial size Roskilde/Herlev Hospital, Denmark:

200 patients in each arm of the study.


Eligibility Criteria:
Inclusion Criteria:

* All patients referred for laparoscopic hysterectomy with or without bilateral salpingectomy or bilateral salpingooophorectomy for benign indications.

Exclusion Criteria:

* Women not suitable for laparoscopic hysterectomy including:

  * Ultrasound appraisal of uterus weight \> 1000 gram
  * Need for prolapse surgery and therefore indication for vaginal hysterectomy.
* Inability to give informed consent
MSC Administration for the Management of Type 1 Diabetic Patients

The purpose of this study is to evaluate whether the administration of multipotent stromal cell also referred as to mesenchymal stem cells (MSCs), modified Type 1 Diabetes progression.

Aim: to evaluate whether a single intravenous administration of allogeneic bone marrow-derived multipotent stromal cell also referred as to mesenchymal stem cells (MSCs), modified endogenous insulin secretion capacity and exogenous insulin requirement in patients with Type 1 Diabetes Mellitus.

Participants: 10, females or males, 18 years or older, diagnosed with Type 1 Diabetes Mellitus at most 1 year before enrollment, under exogenous insulin treatment, with pancreatic reserve of insulin.

Intervention: intravenous administration of a single dose (2-3 millions/Kg) of allogeneic MSCs.

Follow up: before and 1, 6, 24 months after MSC administration.

Eligibility Criteria:
Inclusion Criteria:

* differential diagnosis of Type 1 Diabetes
* diagnosed performed at most 1 year before enrollment
* pancreatic reserve of insulin higher than 0.8 nmol/L/h
* good general health status
* informed consent of patient
* consent of treating physician
* proved psychiatric competence to be enrolled in a clinical study

Exclusion Criteria:

* pregnancy
* significant comorbidities
* HIV, HBV, HCV, HTLV-1, HLTV-2 or VDRL positive
Pancreatic Insufficiency Secondary to Tobacco Exposure

Pancreatic insufficiency is a condition in which there is a decrease in the production and release of enzymes made in the pancreas, which causes nutrient malabsorption. There are many chronic diseases that can lead to pancreatic insufficiency. In the early stages of this disease, a patient may not experience any symptoms, and the prevalence of pancreatic insufficiency may be underestimated. Smoking has long been recognized as a cause of disease in many organs in the body. Cigarette smoke causes inflammation and damages tissue, including the pancreas. Studies have shown that smoking is an independent risk factor for pancreatic cancer and chronic pancreatitis. It has also been shown that the more a person smokes, the worse his disease will be. Additionally, there are studies that show that smokers have nutritional deficiencies. There are observational and retrospective studies that suggest that pancreatic insufficiency may also be caused by smoking. However, this has not been established, and the relationship has not been examined in a controlled manner. This study examines the relationship between smoking and pancreatic insufficiency in patients who do not have other pancreatic diseases.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female at least 30 years of age
2. Able to read, understand, and sign informed consent
3. Patients with a negligible smoking history (defined as no smoking for the past 7 years, and a total smoking history ≤ 5 pack-years) OR patients with AT LEAST a 20 pack-year smoking history

Exclusion Criteria:

1. Patients with a prior diagnosis of pancreatic insufficiency
2. Patients who have a current or remote history of acute or chronic pancreatitis or any other primary pancreatic disease or malignancy
3. Patients who have had pancreatic surgery
4. Patients with a diagnosis of small bowel malabsorption or Celiac disease
5. Patients with any other significant systemic disease that is deemed by the investigator as possibly interfering with the conduct or interpretation of the study
Treatment for Acute Postoperative Voiding Dysfunction

If patients are unable to have their foley catheter removed because their bladder is not emptying well, they may be eligible for study participation. This study is designed to evaluate whether Posterior Tibial Nerve Stimulation is effective in improving bladdder function after surgery. Study participation is limited to one day.

If patients fail a voiding trial (the test done to see if a foley catheter is ready to be removed after surgery), they may be offered participation in this trial. Patients are randomized to receive active treatment or a sham treatment. A small, accupuncture-type needle is inserted through the skin just above the ankle. A small, battery-powered generator will be attached to the needle. The generator will give a low-voltabe stimulation which is adjusted for comfort level and applied for 30 minutes. After treatemnt, the voiding trial will be repeated.

Eligibility Criteria:
Inclusion Criteria:

* First voiding trial after Urogynecological surgery shows that bladder is not emptying well.

Exclusion Criteria:

* Patient declines participation.
Population Health Management for KPNC Members With Newly Diagnosed Diabetes: A Randomized Trial of a Proactive and Augmented Initial Care Strategy

This study is a 2-arm randomized trial of Augmented Initial Type 2 Diabetes (T2D) Care vs. Usual Initial T2D Care among adults (18-74 years) with newly diagnosed T2D who have risk factors (defined by age and diagnosis HbA1c value) for suboptimal early glycemic control. Augmented Initial T2D Care comprises the elements of usual care augmented by more proactive and intensive outreach from the diabetes care team. The study team will use electronic health record (EHR) data to assess between-arm differences in diabetes-related outcomes at 6- and 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-74 years
* Newly diagnosed with type 2 diabetes
* Kaiser Permanente Northern California member receiving care in a participating service area
* If age ≤45 years, then HbA1c\>8%
* If age\<45 years, then HbA1c\>10%

Exclusion Criteria:

* Individuals who are pregnant
* Individuals with likely type 1 diabetes (T1D)