cyrilzakka/clinical-trials huggingface dataset:
WeArable TeChnology DaTa DriVen DigitAl HealTh COachINg (ACTIVATION)- a Mixed-methods Study

Public health priorities have shifted towards disease prevention, emphasising health promotion and lifestyle interventions to reduce disease burden. Despite global efforts, the prevalence of chronic diseases remains high, with lifestyle factors such as alcohol consumption, diet, smoking, obesity, and sedentary behaviour playing significant roles. In Singapore, suboptimal lifestyle behaviours are common, contributing to a high incidence of chronic conditions. Metabolic syndrome (MetS), linked to obesity, poses a growing societal burden due to its association with cardiovascular risks. Disparities exist in the delivery of lifestyle interventions among healthcare providers (HCPs), with many patients receiving inadequate guidance. Digital health coaching, incorporating wearable technology, offers promising solutions to bridge these gaps, providing personalised, real-time support and feedback to improve lifestyle behaviours and prevent disease progression. Challenges such as time constraints, lack of feedback, and limited support can be addressed through remote monitoring and tailored interventions, making scalable population-level interventions feasible.


Eligibility Criteria:
Inclusion Criteria:

* 21-75 years old
* Patients who are at risk of any of the following:

  1. Elevated blood pressure
  2. Overweight (BMI\>=23kg/m2)
  3. Pre-diabetes, OR
* Patients who have one or more of the following (HOLD) conditions:

  1. Hypertension
  2. Obesity (BMI\>=27.5kg/m2)
  3. HyperLipidemia
  4. Type 2 Diabetes Mellitus
* Patients who own a smartphone
* Patients who are willing to wear a smartwatch during the intervention period.

Exclusion Criteria:

* Patients who have a medical condition that prevented participation in physical activity
* Patients who have current diagnosis or history of eating disorder, depression
* Patients who are currently pregnant or planning to become pregnant in the next 6 months
* Patients who are currently participating in a weight loss programme (commercial, medically supervised, or research study)
* Patients who are on weight loss medications (over-the-counter or prescription)
* Patients who are not mentally-, physically- or technologically-capable
* Patients who is unable to provide informed consent.
Prospective, Multi-center, Single-arm Study to Assess the Safety of Retrieval of the Recovery G2 Filter.

This study was designed to assess the safety of retrieval of the Bard Recovery® G2® Filter System. The G2 filter is an FDA-cleared device for inferior vena caval interruption in patients with pulmonary thromboembolism.


Eligibility Criteria:
Inclusion Criteria:

* The patient is at temporary , increased risk of pulmonary embolism requiring caval interruption

Exclusion Criteria:

* The patient has implanted filter in the IVC or superior vena cava (SVC)
* The patient has a duplicated or left-sided IVC
* The patient has a known untreatable or uncontrollable malignancy
* The patient has severe spinal deformity
* The patient has a creatinine \> 2.0 mg/dl
* The patient has a life expectancy of \< 6 months
Temozolomide Versus Dacarbazine in Stage IV Metastatic Melanoma (Study P03267)

The purpose of this study is to ascertain if the extended schedule of Temozolomide, which allows increased doses and potential depletion of the enzyme underlaying resistance, is a more effective treatment of metastatic melanoma than single agent dacarbazine.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed, stage IV, surgically incurable melanoma
* Age 18 years or older
* World Health Organization (WHO) Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Meets protocol requirements for specified laboratory values
* Must be able to take oral medication
* Must be disease free from cancer for period of 5 years (except for surgically cured carcinoma in-situ of the cervix and basal or squamous cell carcinoma of the skin).
* Women of childbearing potential and men must be practicing a medically approved contraception.
* Must provide written informed-consent to participate in the study.
* Must have full recovery from major surgery or adjuvant treatment
* No clinically uncontrolled infectious disease including HIV or AIDS-related illness

Exclusion Criteria:

* Ocular melanomas
* Brain Metastases
* Prior cytokine or chemotherapy for stage IV disease
* Pregnant or nursing women
Efficacy of a Home-Use Photobiomodulation Device for the Treatment of Patients With Knee Osteoarthritis

Osteoarthritis is a degenerative disease affecting joint cartilage and its surrounding tissue. It is the leading cause of disability in the elderly. Photobiomodulation (PBM), has been used widely for alleviation of pain, reduction of inflammation, and acceleration of wound healing, and particularly to treat knee osteoarthritis (KOA). The purpose of the current study is to determine if B-Cure laser treatments, applied at home, by the patient or personal caregiver in a real-life situation, can reduce pain and improve functionality in patients with KOA.

Eligible patients with knee osteoarthritis will receive a B-Cure laser device for self-application at home in addition to standard care. Patients will be invited to the clinic for 3 visits: baseline, 1, and 2 months. Evaluations at the visits will include physical examination, knee range of motion, time up\&go test, and patient reported outcomes including subjective pain level by visual analogue scale (VAS), functional and quality of life questionnaires.

The study hypothesis is that B-Cure laser treatments, applied, at home, by the patient, can ameliorate KOA related inflammation thereby reducing pain and improving functionality in these patients.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnoses of knee osteoarthritis by American College of Rheumatology (ACR)
2. Kellgren \& Lawrence classification 2-3
3. Knee pain on movement 40 to 90 mm Visual Analog Scale
4. Knee pain and related functional reduction for the last ≥ 3 months
5. Agrees not to use NSAIDs throughout the experiment

Exclusion Criteria:

1. Pregnant or nursing, or with the ability to become pregnant and not using an accepted form of birth control
2. Other causes of knee-related pain (e.g. hip OA, arterial insufficiency, radiculopathy etc) have been ruled out by physical examinations.
3. Knee surgery for KOA
4. Intra-articular steroid injection and/or oral steroid treatment within the last six months
5. Rheumatoid arthritis
6. Active malignancy
7. Uncontrolled diabetes mellitus
8. Neurological conditions: sciatica, neuropathy, multiple sclerosis
9. Other chronic pain conditions that may affect results: Fibromyalgia, back pain, hip pain
10. Has any photobiomodulation (low level laser) device at home or has previously used photobiomodulation for knee pain
11. Has known dermatological sensitivity to light
12. Enrolled in any other clinical trial within the last 6 weeks or enrollment in another clinical trial during participation in this trial.

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Treatment of Peri-implant Mucositis by Means of Implant Decontamination and Modification of the Implant Supported-prosthesis

To test the modification of the implant prosthesis, in order to facilitate access to biofilm control, in combination with decontamination of the implant surface by means of an ultrasonic device with a plastic tip and plastic curettes, in comparison with the decontamination of the implant surface by means of an ultrasonic device with a plastic tip and plastic curettes, and no modification of the implant prosthesis.


Eligibility Criteria:
Inclusion Criteria:

* (1) Presence of, at least, one titanium implant exhibiting peri-implant mucositis, defined as bleeding on gentle probing (0.15 N) in at least one peri-implant site.

  (2) No signs of loss of supporting bone after initial bone remodelling. In cases where baseline radiograph is available, it will be used for comparison, otherwise a maximum of 2 mm of crestal bone loss will be accepted (5).

  (3) Single tooth and bridgework restoration with an inappropriate prosthesis design or contour which difficult oral hygiene access (overcontoured prosthesis, prostheses presenting closed embrasures, an abrupt emergence profile or excessive buccal flanges).

  (4) Presence of \>1 mm of keratinized peri-implant mucosa.

  (5) A good level of oral hygiene, defined as an O'Leary et al. plaque index \<25% (16).

  (6) Absence of systemic diseases that could influence the outcome of the therapy (i.e. controlled diabetes, with HbA1c\<7, patients will be included).

  (7) Non-smoker or light smoking status in smokers (\<10 cigarettes/day).

Exclusion Criteria:

* (1) Untreated periodontal conditions.

  (2) Pregnant or lactating women.

  (3) Patients who received systemic antibiotics in the last 3 months.

  (4) Patients who received treatment of PM in the past 3 months.

  (5) Patients receiving corticoids or medications known to have effect on gingival growth i.e. calcium channel antagonists, immunosuppressants or antiepileptic drugs.

In those cases diagnosed with peri-implantitis, individualized treatment will be provided, apart from the present study.
Prevention of Transmission of Sexually Transmitted Diseases in the Youth Through Effective Intervention,

The data of Taiwan CDC showed the total HIV victims amounted up to 22,020 from 1984 to 2011. Under risk factor analysis, it indicated the increasing victims among MSM (men having sex with men, including homosexuals \& bisexuals) cohorts, from 64% of them in 2009 to 72% in 2011. For age stratification of patients, the youth (from 15 to 24 years old) comprised of 18.5% (4078). Among them, 40% are students. MSM are still the main population (over 80%) from 2009 to 2011. Therefore it is crucial to target the young MSM.

Purpose: Under the hospital based, and in conjuction with the community, we try to target the young HIV MSM victims and develop the partnership networking to seek for the potential high risk couples to enroll into our intervention.

Materials \& Methods: At hospital, though HIV clinic has case manager, however the limitation of space and privacy, we just focus on the HIV patient itself and have limited time to educate patients' sex partners. Therefore, we aimed at enrolling more of the intimate partners thru young HIV MSM victims thru hospital base. We will provide the saliva OraQuick rapid test service to the partners, thus set up the relationship with the study subjects, and then communicate with them and educate them with knowledge of sexual transmitted diseases and sex health. We plan to enroll 200 study subjects till the end of this year. Our co-PI, Prof. Y.M. Chen will also perform HIV gene clustering analysis thru high throughput ultra-deep pyrosequencing among young MSM HIV victims. The other co-PI Prof. P.I. Chou will train the research assistant adopting MSM HIV victim partner follow-up model to approach the study subjects with structured questionnaires. Prof. Chou also collected the study subjects in the northern Taiwan with her own project, thus we can compare and analyze the difference from the locality (North area v.s. South area).

Anticipated work: We aim at enrolling 300 young HIV MSM partners to this OraQuick rapid test, setting up the follow-up model and providing the intervention education of safe sex thru individual case management, group meeting, leader-finding plan and interactive MSM web networking to achieve the preventione of sexual disease transmission in the youth.

Eligibility Criteria:
Inclusion Criteria:

1. Homosexual or bisexual and MSM who have sex.
2. Age over 15 years old to 30 years old.

Exclusion Criteria:

1. Women and heterosexual.
2. AIDS was received within three months of screening those.
The Effectiveness of Dual Therapy (Lopinavir/Ritonavir + LamivudinE) in Treatment-Experienced HIV Infected Patients in the Russian Federation

This study seeks to assess the virologic effectiveness of dual therapy (lopinavir/ ritonavir (LPV/r) + lamivudine (3TC)) in treatment-experienced human immunodeficiency virus 1 (HIV-1) infected participants with an undetectable plasma HIV-1 (ribonucleic acid) RNA level (for at least 6 months) at the 48 week time point of treatment in the routine clinical settings of the Russian Federation.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years and older (male and female).
2. HIV-1 infected patients on any triple HAART with plasma HIV-1 RNA level \<50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r + 3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected patients who were switched on the dual therapy (LPV/r + 3TC) no more than 60 days ago.
3. Cumulative HAART experience at least 6 months.
4. Authorization (Consent) for Use/Disclosure of Data signed by the patient.

Exclusion Criteria:

1. Contraindications to lopinavir/ritonavir and lamivudine
2. Previous participation in this program
Evaluating the Safety and Effectiveness of Liraglutide in Subjects With Type 2 Diabetes

This trial is conducted in Asia. The aim of the trial is to assess the incidence rate and type of SADRs (serious adverse drug reactions).


Eligibility Criteria:
Inclusion Criteria:

* Subjects with type 2 diabetes mellitus, including newly-diagnosed subjects, who require treatment with liraglutide

Exclusion Criteria:

* Subjects who are or have previously been on liraglutide
* Subjects who have previously been enrolled in the study
* Subjects with a hypersensitivity to liraglutide or to any of the excipients
* Subjects who are pregnant, breast feeding or have the intention of becoming pregnant within the study periods
* Subjects with cancer (except basal cell skin cancer or squamous cell skin cancer) or any clinically significant disorder, except for conditions associated with type 2 diabetes mellitus history which in the physicians' opinion could interfere with the results of the trial
* Known or suspected abuse of alcohol or narcotics
Comparison of QoR-15 in Laparoscopic Cholecystectomy: Sugammadex vs. Neostigmine

The quality of recovery in patients who were reversed neuromuscular blockade by using Sumamadex and Neostigmine in laparoscopic cholecystectomy was compared through the QoR(Quality of Recovery)-15 questionnaire.

Quality of Recovery questionnaire includes five details (Emotional status, Physical comfort, Physiological support, Physical independece, Pain), and is a proven method of reliability, consistency and validity for evaluating recovery from surgery and anesthesia.

After laparoscopic cholecystectomy, patients experience various discomforts such as pain, nausea, vomiting, and placebo due to general anesthesia.

Neostigmine has side effects such as crampy abdominal pain, nausea and vomiting. In addition, residual neuromuscular blockade was higher in neostigmine compared with sugammadex.

Although sugammadex expected to improve patient's recovery, it is still controversial that sugammadex contributes to clinically meaningfull difference compared with neostigmine.

Therefore, the aim of our study is comparison of quality of recovery through QoR-15 questionnaire in patients who were reversed neuromuscular blockade by using sugammadex and neostigmine in laparoscopic cholecystectomy.

Eligibility Criteria:
Inclusion Criteria:

* patients who underwent laparoscopic cholecystectomy aged 20-70

Exclusion Criteria:

* neuromuscular disease
* allergy to rocuronium, sugammadex, neostigmine
* cognitive impairment ( disable to answer the questionnaire )
* refuse to participate
Translational Study for BRAFV600 Serum and Plasma Determination in Patients With BRAFV600 Metastatic Melanoma

This is a multi-centric translational study with biological samples collection. The aim of this study is to validate a method to detect BRAFV600 in blood samples.

Samples: Blood from patients with BRAFV600 metastatic melanoma collected following standard medical practice.

The treatment is not the aim of the study. Patients can be treated either with specific or no-specific drug.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of melanoma and BRAFV600
* Signed Informed Consent Form
* Unresectable phase III or phase IV melanoma
* The patients should be starting a treatment for melanoma (either first line or subsequent lines)
Develop and Implement Asthma Controlling Strategies (2)

To develop and implement asthma controlling strategies for inner city and high risk populations.

BACKGROUND:

Asthma is a serious chronic disease affecting about 12 million Americans; about 3 million are children. The study was part of an initiative, "Developing and Implementing at the State and Local Level Educational Strategies and Interventions for Controlling Asthma in Inner City and High Risk Populations", released in February 1993 by the National Asthma Education Program of the Office of Prevention, Education and Control.

Eligibility Criteria:
No eligibility criteria
The Role of the Gut Microbiota in the Systemic Immune Response During Human Endotoxemia

The purpose of this study is to determine whether treatment with antibiotics, which harm the gut flora, causes the immune system to be less effective.

Rationale: Sepsis ranks among the top ten leading causes of death worldwide. Most nonsurvivors die in a state of immunosuppression. The gut microbiota exerts numerous beneficial functions in the host response against infections. Gut flora components express microorganism-associated molecular patterns (MAMPs) such as lipopolysaccharide (LPS), which are recognized by pattern recognition receptors (PRRs) expressed by neutrophils and macrophages. MAMPs from the intestinal microbiota constitutively translocate to the circulation and prime bone marrow derived neutrophils via PRRs. Antibiotic treatment, which is standard of care for all patients with sepsis, depletes the gut microbiota and leads to a diminished release of MAMPs and other bacteria derived products. This causes diminished priming of systemic immunity, which may attribute to sepsis associated immunosuppression and an increased susceptibility to invading bacteria.

Objective: To investigate the role of the gut microbiota in the systemic priming of immune effector cells during human endotoxemia

Study design: Randomized, between- and within-subject-controlled intervention study in human volunteers

Intervention: All subjects will receive lipopolysaccharide (endotoxin; 2 ng/kg bodyweight) intravenously to induce experimental endotoxemia. Eight subjects will be pretreated with broad spectrum antibiotics (ciprofloxacin, vancomycin, metronidazole) for seven days (washout period of 36 hours before endotoxemia), in order to deplete the gut microbiota. Blood and faeces will be sampled before, during and after endotoxemia.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Male between 18 and 35 years of age
* Capable of giving written informed consent
* Chemistry panel without any clinically relevant abnormality
* Normal defecation pattern

Exclusion Criteria:

* Major illness in the past 3 months or any chronic medical illness
* History of any type of malignancy
* Past or current gastrointestinal disease
* Known positive test for hepatitis C antibody, hepatitis B surface antigen or HIV antibody 1 or 2
* Current or chronic history of liver disease
* Subject uses tobacco products
* History, within 3 years, of drug abuse
* History of alcoholism
* Any clinically relevant abnormality on the 12-lead ECG
* The subject has received an investigational product within three months
* Use of prescription or non-prescription drugs
* Use of antibiotics within 12 months
* Known allergy to antibiotics
* Subject has difficultly in donating blood or accessibility of a vein in left or right arm.
* Subject has donated more than 350 mL of blood in last 3 months
* Difficulty swallowing pills
* Body mass index more than 28
Investigation on the Surgical Treatment Effect of Periprosthetic Femur Fracture After Hip Arthroplasty

To Investigate the Surgical Treatment effect of Periprosthetic Femur Fracture After Hip Arthroplasty

In the study，155 patients from multiple center with periprosthetic femur fracture after hip arthroplasty are planned to be recruited. All the patients are treated surgically according to Vancouver classification，and their fracture union，pain in fracture site and lower extremity length are evaluated at 6 months and 1 year postoperatively．Also Harris scores are used to assess hip function at the 2 time points.

Eligibility Criteria:
Inclusion Criteria:

patients with periprosthetic femur fracture after hip arthroplasty

Exclusion Criteria:

Severe complications after surgery
A Multi-Center Study on the Use of Rho-Kinase Inhibitor to Reduce or Prevent PVR in RRD Eyes at High Risk for PVR

The purpose of this study is to determine if a drug called netarsudil is safe and able to prevent the development of scar tissue after retinal detachment repair. Patients eligible for this study are those diagnosed with a rhegmatogenous retinal detachment deemed at high risk for scar tissue formation (a process called 'proliferative vitreoretinopathy').


Eligibility Criteria:
Inclusion Criteria:

A patient must meet the following criteria to be eligible for inclusion in the study:

1. Diagnosed with primary RRD at high risk for PVR development. Specifically, the enrolled eye must include at least 1 but no more than 3 high risk features, which are designated as follows: multiple retinal breaks (3 or more); detachments involving two or more quadrants of the retina; duration of detachment \> 3 weeks; vitreous hemorrhage; and choroidal detachment.
2. Consents to surgical repair with pars plana vitrectomy with or without scleral buckling
3. Willing and able to comply with clinic visits and study-related procedures
4. Able to provide a signed informed consent

Exclusion Criteria:

A patient who meets any of the following criteria will be excluded from the study:

1. Age \< 18 years
2. Presence of PVR grade B or worse (as defined by the revised Retina Society PVR classification system) at time of surgical repair
3. Primary RRD repair is primary laser demarcation, primary cryotherapy, pneumatic retinopexy, or scleral buckling procedure alone.
4. Primary use of silicone oil or retinectomy during surgical repair
5. Prior incisional ocular surgery other than cataract extraction
6. History of or concurrent ruptured globe, intraocular foreign body, diabetic retinopathy, retinal vein occlusion, exudative age-related macular degeneration, macular hole, epiretinal membrane, sickle cell disease, uveitis or intraocular infectious disease
7. Not willing or unable to comply with clinic visits and study-related procedures
8. Unable to provide a signed informed consent