cyrilzakka/clinical-trials huggingface dataset:
Smart Wearable Insights to Prevent Exacerbations and Recurrence - Rehabilitation Study: SWIPER-REHAB

Aims of the study:

* To measure the rate of completion of a digital cardiac rehabilitation programme at Imperial College Healthcare NHS Trust (ICHNT)
* To measure the health economic impact of a digital cardiac rehabilitation programme at ICHNT

Any adult patient eligible for ICHNT cardiac rehabilitation (CR) programmes is eligible to participate. Participants will receive a commercially available smart watch and be asked to wear the device as much as possible. In addition, they will be asked to download a smartphone application called 'Imperial Healthy Hearts', which displays movement and information on heart rate, breathing and oxygen levels to both the participant and the research team (digital data). The Healthy Hearts app also allows the direct care team to provide educational materials to patients as part of their routine care.

The clinical content and structure of the CR programme is determined by the clinical CR team, and does not deviate from established local and national standards and practices.

Researchers will capture physiological data such as heart rate, respiratory rate, blood pressure (where available) and oxygen saturation (where available) via the Healthy Hearts platform. Researchers will also capture clinical information from the electronic health record, and will compare CR programme uptake and completion rates with historical data and national targets.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or above
* Able to give informed consent
* Eligible for Cardiac Rehabilitation programme

Exclusion Criteria:

* Any wrist wound, skin pathology or other feature that would prohibit the wearing of a smartwatch
* Any visual impairment preventing the use of the Fitbit or smartphone application.
Project U Connect - Optimizing Brief Alcohol Intervention for Underage Drinkers in the ER

The Emergency Department (ED) setting is a unique point of access for reaching underage drinkers (age 14-20). With the aid of computer technology, this study will screen underage drinkers in the ED and fully test promising ED-based brief intervention and 3-month follow-up brief treatment approaches for alcohol misuse. Developing methods to efficiently and effectively optimize these approaches has powerful public health implications for improving outcomes for underage drinkers.

The proposed study will use computerized screening using touchscreen computer tablets with audio (\~5,700 patients) and will test a developmentally appropriate, tailored intervention. Specifically, 900 patients aged 14-20 in the ED who screen positive for problematic alcohol use in the past 3 months will be randomized to the combinations of three ED-based conditions: 1) computer brief intervention-CBI; 2) therapist/intervener delivered brief intervention-IBI; or 3) enhanced usual care-EUC. All participants will be randomized to one of two follow-up conditions: 1) adapted motivational enhancement therapy-AMET; or 2) enhanced usual care-EUC that will take place 3 months post-ED. All participants will receive written information regarding community resources; individuals who meet alcohol use disorder criteria will additionally receive substance use treatment referrals.

Recognizing that brief interventions are important, but not necessarily sufficient, for change in all adolescents and young adults who misuse alcohol, the primary specific aims of the proposed study will determine the independent effectiveness of immediate "on-the-spot" ED-based brief intervention conditions, 3-month follow-up brief treatment conditions, and combinations of conditions, for decreasing alcohol use and improving health-related outcomes (including injury, mental health, and other risk behaviors) at 6- and 12-months follow-up.

Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria for screening:

* (1) Patients age 14-20 years presenting to the UMMC ED for medical care
* (2) ability to provide informed consent.
* Additional inclusion criteria for intervention based on "alcohol misuse": Participants screening positive on the AUDIT for problematic alcohol use in the past 3 months will be eligible for the randomized control trial.

Exclusion Criteria:

* (1) patients who do not understand English
* (2) patients deemed unable to provide informed consent (e.g., mental incompetence, prisoners);
* (3) adolescents ages 14-17 presenting without a parent/guardian; and
* (4) patients treated in the ED for suicide attempts or sexual assault.
Direct-acting Antivirals and Hepatocellular Carcinoma Recurrence

Background and Aims: Arrival of direct-acting antiviral (DAA) agents against hepatitis C virus (HCV) with high-sustained virological response (SVR) rates and very few side effects has drastically changed the management of HCV infection. The impact of DAA exposure on hepatocellular carcinoma (HCC) recurrence after a first remission in patients with advanced fibrosis remains to be clarified.

Methods: 68 consecutive HCV patients with a first HCC diagnosis and under remission, subsequently treated or not with a DAA combination, were included. Clinical, biological, and virological data were collected at first HCC diagnosis, at remission and during the surveillance period.


Eligibility Criteria:
Inclusion Criteria:

* first HCC diagnosed by invasive or non-invasive criteria following the American Association for the Study of Liver Diseases (AASLD) guidelines during the study time horizon
* complete remission after hepatocellular carcinoma treatment defined by the European Association for the Study of the Liver (EASL) criteria as absence of residual tumor/complete necrosis at imaging one month after the end of hepatocellular carcinoma treatment

Exclusion Criteria:

* prior history of hepatocellular carcinoma before January 2009
* liver transplantation before hepatocellular carcinoma diagnosis
* presence of "non-characterized nodules" after hepatocellular carcinoma treatment at imaging
* history of direct-acting antivirals treatment before the first hepatocellular carcinoma diagnosis
* hepatic decompensation
* human immunodeficiency virus (HIV) coinfection.
Magnetic Resonance Imaging Using Innovative Pulse Sequences

The purpose of the study is to collect in vivo human image data to demonstrate neurological magnetic resonance imaging (MRI) of subjects using short pulse sequences.

This is a single-site; open-label, prospective research Study involving human subjects. There will be no comparative efficacy or safety analysis and therefore no randomization

Eligibility Criteria:
Inclusion Criteria:

* Subject must be at least 18 years of age
* Subject must be willing and able to undergo verbal and written informed consent
* Subject must have a clinical indication for a head MRI with and without Gadolinium-based contrast agent administration

Exclusion Criteria:

* Subjects who have any of the conditions below at the time of the enrollment or scan session are excluded from this study. Further, should it be determined by study staff that an enrolled subject meets any of the conditions below during the course of the study, the subject will be removed from the study.

  * Any contraindication to an MRI scan per the policy of Spectrum Health
  * Any contraindication to administration of an MRI contrast agent per the policy of Spectrum Health
  * Off-label utilization of contrast agents administered for the subject's clinical exam
Recurrent GBM With Maximal Neurosurgical Removal and Treatment With IORT

The purpose of this study is to assess the safety and efficacy of the Xoft Axxent eBx System when used for single-fraction IORT for recurrent Glioblastoma. IORT using the Xoft Axxent eBx System is no worse than (non-inferior) GliaSite radiation therapy when used as stand-alone radiation treatment immediately following maximal safe neurosurgical resection in patients with recurrent glioblastoma multiforme (GBM).

Device Description: The Xoft Axxent Electronic Brachytherapy System is a device that delivers radiation at a high dose rate. It is designed for use with Axxent applicators to treat lesions, tumors, and conditions in or on the body where radiation is indicated. The Axxent System and Applicators are FDA cleared under 510(k)s K050843, K072683, K090914 and K122951.

The purpose of this trial is to assess the overall survival of patients treated with the Xoft Axxent eBx System for single-fraction IORT following maximal neurosurgical resection of recurrent glioblastoma. A historical comparison will be made for surgical excision and GliaSite radiation therapy (Chan 2005), which resulted in a median OS of 9.1 months.

Radiation is delivered to the target tissue (adjacent to the resection margins). It avoids treatment delays and eliminates weeks of post-surgical radiation therapy during which residual cancer cells might proliferate.

Eligibility Criteria:
Inclusion Criteria:

1. Potentially-resectable, histologically proven recurrent GBM
2. Subject must be ≥ 18 years of age
3. Subject must have a Karnofsky Performance Score ≥ 70%
4. Subject must have had a T1 weighted 3D MRI with Gadolinium enhancement within fourteen (14) days prior to surgery
5. Women of child-bearing potential must have a negative pregnancy test within one week of IORT treatment
6. Subjects of child-bearing potential must agree to use adequate contraceptive precautions and not to breastfeed (if applicable)

Exclusion Criteria:

1. More than three relapses
2. Subject has multi-centric disease
3. Subject has tumors in or near (less than 10mm from tumor margin) critical brain structures, that would exclude sufficient dose delivery to the tumor: such as:

   1. Optic Chiasm
   2. Optic Nerve
4. Women who are pregnant or nursing. Women with child-bearing potential or sexually active men that are not willing/able to use medically acceptable forms of contraception
5. Subject has contraindications for MRI with or without gadolinium injections
6. Subject has contraindications for anesthesia or surgery
7. Subject is on another therapeutic clinical trial concurrently
8. Subject had previous radiation for GBM less than 3 month earlier
9. Prior history of standard dose of Central Nervous System (CNS) of more than 60 Gy

Intra-Operative Exclusion Criteria

1. Frozen section does not show any sign of malignant tissue
2. Dose at any organ at risk will exceed 10 Gy including:

   1. Chiasm
   2. Optic Nerve
Korean Medicine Patient Registry of Postoperative Therapy for Musculoskeletal Disorders (KPOP-MD): A Study Protocol

To create an infrastructure that allows for the conduct of prospective, controlled studies comparing the effectiveness of diagnostic and treatment strategies for patients with musculoskeletal disorders after musculoskeletal operations


Eligibility Criteria:
Inclusion Criteria:

* aged 19 and over
* Those who have undergone musculoskeletal related surgery (corresponding to the disease classification code M00-99, S00-99) within 3 years
* voluntary applicant who has no problem with communicate with study associates or a mild cognitive impairment patient who scored higher than 23 points in Korean version of the montreal rating questionnaire with voluntary participation

Exclusion Criteria:

* Participants in other clinical trials
* Those who are unlikely to be adhered to the schedule of clinical studies
* Those who are expected to have difficulty understanding and responding to research questionnaires such as illiteracy, mental and physical weakness
Saw Palmetto: Symptom Management for Men During Radiation Therapy

The aim of this study is to test whether Saw Palmetto, is useful in preventing or reducing the side effects for men undergoing radiation therapy for prostate cancer. Urinary symptoms will be recorded each week, as well as assessment of quality of life through: 1) Physical Well-Being 2) Social/Family Well-being 3) Emotional Well-Being, and 4) Functional Well-Being.

Lower urinary tract symptoms (LUTS) affect from 75-80% of men undergoing radiation therapy (RT) for prostate cancer. The purpose of this study was to determine the feasibility, safety and efficacy of inexpensive, non-toxic herbal supplement, Saw Palmetto (SP), in treating these distressing symptoms.

The study consisted of two phases: Dose Finding phase (DFP), and Exploratory Randomized Controlled Trail (RCT) phase. In the 12 week DFP, participants were given one of three doses (SP 320 mg, SP 640mg, and SP 960 mg) using the Time-to-Event Continual Reassessment Method to determine the maximum therapeutic dose (MTD). Once the MTD was determined the RCT phase was begun, participants were allocated to receive either the predetermined MTD (960 mg) in the DFP or a placebo to obtain preliminary evidence of efficacy of SP on LUTS.

Safety data consisted of the Common Terminology for Adverse Events criteria for nausea, gastritis, and anorexia. Efficacy of the MTD was evaluated by weekly symptom data and voiding diary. A pill diary was used to ensure the intervention fidelity.

Eligibility Criteria:
Inclusion Criteria:

* Age 21 years or older
* Adenocarcinoma of the prostate
* Serum Prostate Specific Antigent (PSA) ≤ 40ng/ml
* Combined Gleason Score ≤ 8
* Karnofsky level of performance of \> 70%
* Consented to undergo definitive Radiation Therapy

Exclusion Criteria:

* Stage T4 or M1
* Patient using own supply of Saw Palmetto or any other supplement containing the following herbs: Pygeum (African Plum), Urtica Dioica (Stinging nettle), Cucurbita peponis (pumpkin seed), PC-SPES (combination of 8 herbs), Beta-sitsterol (plant sterols) or Cernilton (rye grass pollen).
* Prior pelvic radiation therapy
* Abnormality in liver and kidney function as evidenced by greater than twice the normal values of Blood Urea Nitrogen (BUN), serum creatine, serum transaminases, and alkaline phosphatase.
* Uncontrolled hypertension despite use of antihypertensive medication
* Presence of major psychiatric or medical illness (e.g., major cardiovascular events within the previous 12 months)
Study to Compare Sevelamer Carbonate Powder to Sevelamer Hydrochloride Tablets in Patients With CKD on Hemodialysis

Approximately 207 patients with chronic kidney disease (CKD) on hemodialysis will be entered into this study at approximately 26 centers in the United States. This study aims to evaluate the safety and efficacy of sevelamer carbonate powder dosed once-a-day (QD) with the largest meal compared to sevelamer hydrochloride tablets dosed three-times-per-day (TID) with meals. The total length of participation is approximately 24 weeks.


Eligibility Criteria:
Inclusion Criteria:

* On three times per week hemodialysis for three months or longer
* Currently on a phosphate binder(s)
* Considered compliant with phosphate binders and hemodialysis therapy
* Willing to avoid any intentional changes in diet such as fasting or dieting
* Have the following documented local laboratory measurements:a.Two most recent consecutive serum phosphorus measurements that are ≥ 3.0 and ≤ 6.5 (6.5) mg/dL within 60 days of screening; b.A most recent intact parathyroid hormone (iPTH) measurement ≤ 800 pg/mL within 90 days of screening
* Have the following central laboratory measurements: a.A serum phosphorus measurement \> 5.5 mg/dL at randomization (Week 0);b.A serum iPTH measurement ≤ 800 pg/mL at screening
* Have not participated in any other investigational drug studies within 30 days prior to enrollment
* Level of understanding and willingness to cooperate with all visits and procedures as described by the study personnel
* Willing and able to take sevelamer alone as a phosphate binder for the duration of the study
* Willing and able to maintain screening doses of lipid medication for the duration of the study, except for safety reasons
* Willing and able to avoid antacids and phosphate binders containing aluminum, magnesium, calcium or lanthanum for the duration of the study unless prescribed as an evening calcium supplement
* If female and of childbearing potential (pre-menopausal and not surgically sterile), willing to use an effective contraceptive method throughout the study, which includes barrier methods, hormones, or intrauterine devices (IUDs)
* Life expectancy of 12 months or greater
* Willing and able to provide informed consent

Exclusion Criteria:

* Active bowel obstruction, dysphagia, swallowing disorder, or severe gastrointestinal (GI) motility disorders
* Active ethanol or drug abuse, excluding tobacco use
* In the opinion of the Investigator, subject has poorly controlled diabetes mellitus, poorly controlled hypertension, active vasculitis, HIV infection, or any clinically significant unstable medical condition
* Use of anti-arrhythmic or anti-seizure medications for the use of arrhythmia or seizure disorders
* Known hypersensitivity to sevelamer or any constituents of the study drug
* Pregnant or breast-feeding
* Evidence of active malignancy except for basal cell carcinoma of the skin
* Unable to comply with the requirements of the study
* Any other condition which, in the opinion of the Investigator, will prohibit the subject's inclusion in the study
Comparison Between OSS and 2L PEG/Asc for Bowel Preparation of Elderly People

For evaluation of the usefulness of oral sulfate solution (OSS) for bowel preparation of elderly people, investigators compare the efficacy, tolerability and safety between OSS and 2L polyethylene glycol (PEG) with ascorbic acid (Asc).

This study is a multicenter, prospective, randomized parallel arm, investigator initiated trial.

The aim of study is to compare oral sulfate solution (OSS) with 2L polyethylene glycol (PEG) with ascorbic acid (Asc) for bowel preparation in elderly people.

99 participants will be enrolled in each group (198 in total). The primary outcome is the efficacy of bowel preparation. Secondary outcomes are tolerability, satisfaction, and safety.

Eligibility Criteria:
Inclusion Criteria:

* Colonoscopy examinee aged 65-80
* Examinee agree with informed consent

Exclusion Criteria:

* Cognitive disorder, mental retardation
* Bowel obstruction
* Severe constipation (\<3 bowel movements per week with or without regular or intermittent laxatives)
* History of bowel surgery
* Liver cirrhosis or ascites
* Heart failure, cardiac disease (ischemic heart disease or coronary artery disease within the last 6 months)
* Inflammatory bowel disease
* Pregnancy, lactating woman
* Renal impairment or history of impaired renal function
* History of hypersensitivity reaction to bowel preparation
Study of a Bone Assessment Technique, Bone Mineral Analyser, Concerning the Prediction of Improvement in Bone Status After an Infusion of Zoledronic Acid in Osteoporotic Women

* Collection of epidemiological data
* Biological assessment as part of routine care.
* Measurement of the Hurst coefficient at D0
* Measurement of bone density and TBS on D0
* Zoledronic acid infusion the month following inclusion
* phone call at 1 month (observance of zoledronic acid)
* Measurement of bone density, calculation of the Hurst coefficient at M12


Eligibility Criteria:
Inclusion Criteria:

* Women \< 85 years old
* Postmenopausal women (amenorrhea for more than 12 months), a confirmation diagnosis should be obtained (amenorrhea for at least 12 months before the inclusion visit).
* Post-menopausal osteoporosis with one or more severe fractures (upper end of the humerus, femur, or tibia; 3 adjacent ribs; lower end of the femur; thoracic or lumbar spine; pelvis), or T score \<-3 which justifies setting up a bisphosphonate treatment
* Affiliated to social security

Exclusion Criteria:

* Contraindication to zoledronic acid (allergy to the product, creatinine clearance \<35 ml / min, hypocalcemia, open and unhealed lesions of the soft tissues of the mouth)
* Hormone replacement therapy taken in the last 12 months
* Osteoprotective treatment (bisphosphonates, teriparatide, raloxifene, strontium ralenate or denosumab) taken in the last 12 months
* Secondary osteoporosis: hyperthyroidism, hyperparathyroidism, long-term corticosteroid therapy, hypercorticism, hypogonadism, treatment with anti aromatases / LHRH analogues, neoplastic pathology (solid or hemopathy)
* History of bilateral wrist or femur fracture
* Person deprived of liberty by an administrative or judicial decision or person placed under the protection of justice / guardianship or curatorship
* Patient participating in another trial / having participated in another trial within 6 months
Bioactive Restorative Material in Non-Carious Cervical Lesions

Evaluating the clinical performance of a bioactive restorative materiel (Cention N) placed in non-carious cervical lesions (NCCLs) with no preparation and 1-step adhesive system or, with preparing a gingival retentive groove and no adhesive system.

Cention N is a relatively new restorative material that is known to be the first commercially available bioactive resin composite. The manufacturing company recommends using Cention N with 1-step adhesive system in non-retentive cavities, or with no adhesive system in retentive cavity preparations.

This study was designed to evaluate the clinical performance of this material in non-carious cervical lesions by comparing it to RM-GIC (Fuji II LC).

Information about oral and tooth brushing habits along with detailed information about the characteristics of each NCCL, gingival status, and preoperative sensitivity will be collected for each patient.

Eligibility Criteria:
Inclusion Criteria:

* Good general health
* with at least 20 teeth under occlusion
* Should have three or more NCCLs which share the characteristics of being deeper than 1 mm, and involve both the enamel and dentin of vital teeth without mobility

Exclusion Criteria:

* Poor oral hygiene
* Severe periodontitis
* Severe bruxism habits
* Xerostomia