cyrilzakka/clinical-trials huggingface dataset:
DigiVis: Self-testing Vision App for Telephone Consultations

This trial aims to assess the accuracy and test-retest variability of a new digital app which enables community visual acuity testing without requirement of an trained examiner.

Eye problems like macular degeneration and amblyopia (lazy eye) require regular monitoring to prevent permanent visual impairment. Over 2000 patients a month are seen in Cambridge University Hospitals National Health Service Trust (CUH) eye clinics; concern about Covid-19 infection has led to over 80% of consultations being conducted by telephone with few clinical clues to inform decision making. Patients will face long delays even when routine clinics restart: there is no doubt that some will suffer preventable visual loss.

DigiVis is a web-based vision testing app enabling self-testing of vision at home. Early testing and patient feedback is positive: 80% of children prefer DigiVis to regular testing. The investigators wish to test how accurately the app works for home use, by asking older children and adults to self-test their vision prior to their planned face to face clinic appointment. Once tested, DigiVis will be available free of charge to patients, not only during the Covid-19 crisis, but also to support telephonic consultations in the future.

Visual acuity (VA) is a fundamental measure of vision required for all ophthalmic assessments. It is measured by health professionals using vision charts. DigiVis is a new app which enables self-testing of VA using two wirelessly connected digital devices. By matching letters on a handheld device to those displayed on the second device a distance away, threshold VA can be measured using a staircase algorithm. The distance and scaling of the test is vital to its accuracy and a concept (patent filed by Cambridge Enterprise) in DigiVis enables this without the need for manual distance measurement or an observer.

Early validation using two tablet computers in 150 clinic patients has given positive results, both in testing accuracy and patient feedback. With the current Covid-19 crisis limiting face to face appointments, there is an urgent need for accurate home VA assessment. The DigiVis app has been re-coded for free website delivery for this purpose.

The investigators wish to formally validate DigiVis home testing following Conformitè Europëenne (CE class I) marking so that it can be recommended for clinical use. 250 patients will be invited to self-test their VA twice using DigiVis prior to a planned face to face clinic appointment. The test-retest variability and comparison of DigiVis VA to chart based assessment will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Age between 5 and 85 years
* Previous recorded visual acuity of at least +0.8 logMAR in or both eyes

Exclusion Criteria:

* Individuals with poor conversant English
* Individuals with cognitive impairment
* Subjects unable to access the internet on two digital devices
Efficacy of Sr-89 for Differentiated Thyroid Cancer With Bone Metastases

Using sensitive markers (such as thyroglobulin, etc) to evaluate the efficacy of strontium-89 chloride (Sr-89) in differentiated thyroid cancer with bone metastases with an aim to breaking out of its palliation effect for bone pain.

Using biochemical markers (such as thyroglobulin), functional markers (such as change of tumor-background ratio on bone scan), etc to evaluate the efficacy of strontium-89 chloride (Sr-89) in differentiated thyroid cancer with bone metastases with an aim to breaking out of its palliation effect for bone pain.

Eligibility Criteria:
Inclusion Criteria:

* Patients of differentiated thyroid cancer
* Positive uptake by bone metastases on bone scan
* Planing to have Sr-89 treatment

Exclusion Criteria:

* Having received treatment for bone metastases within one month of the study (such as radiotherapy, surgery, targeted therapy, chemotherapy, etc., among which denosumab and bisphosphate were allowed as basic treatment)
* Having received radioactive iodine therapy within half a year before the study
* There are bone related events, such as fracture, spinal cord compression, etc.
Feasibility of a Behavioral Activation Trial

The goal of this project is to train community mental health therapists in behavioral activation (BA) treatment for major depressive disorder and then to conduct a study examining the feasibility of evaluating the effectiveness of BA in this setting.

After finalizing a 9-session BA treatment model for major depressive disorder in the Community Mental Health Center (CMHC) setting, the final treatment manual will be used to train clinicians in BA at the CMHC through workshops and training cases.

Upon completion of training and certification of adequate implementation of BA, a total of 80 patients with MDD will be randomly assigned in a 3:1 ratio to 9 sessions of BA or treatment-as-usual (TAU) at the CMHC. Feasibility will be assessed in terms of (1) percent of eligible patients who refuse randomization, (2) percent of patients who complete 9 sessions of BA treatment, (3) percent of BA homework assignments that are completed, (4) percent of monthly assessments obtained, and (5) patient ratings of credibility and alliance in BA treatment. The ability of CMHC therapists to adequately implement BA will be assessed by rating taped sessions on BA adherence and competence scales. In addition to feasibility/acceptability of BA and TAU, this study is designed to test whether theoretically important targets of BA change over the course of BA treatment, and whether such changes are associated with changes in depressive symptoms. The target measures will be assessed at baseline, month 1, month 2, and month 3. To support the potential role of these targets as the mechanisms of change in BA, change in the target variables will be examined in relation to change in depression symptoms. The investigators will also pilot a potential moderator of treatment effects (trait reward processing, as measured at baseline using the Effort-Expenditure for Rewards Task) to include this potential moderator in a subsequent fully-powered study with the long-term goal of identifying the types of patients most responsive to BA.

Eligibility Criteria:
Inclusion Criteria:

1. confirmed diagnosis of MDD based on the SCID for DSM-IV (or DSM-V, if available),
2. ability to read at least at the 4th grade level,
3. willingness to participate in research,
4. willingness to be audio recorded (for both therapists and patient- participants)

Exclusion Criteria:

1. current or past psychotic disorder, seizure disorder, or clinically significant organic pathology
2. acute medical problem requiring immediate inpatient treatment,
3. current substance abuse or dependence requiring primary referral to substance abuse program,
4. significant suicidal risk/ideation requiring immediate referral or suicidal gesture within the last 3 months
Continuous Monitoring of Patients With Chronic Obstructive Pulmonary Disease

An open, single group, single center Study to confirm CTC-Actiwise™ as a means to record and monitor the progression of a patient's COPD.

Chronic Obstructive Pulmonary Disease (COPD) affects growing patient groups. Current knowledge about the disease limits the investigators ability to cure or interfere with the progression of the disease. COPD is often characterized by exacerbating infections requiring emergency care.

The project aims to examine whether disease progression of COPD can be better controlled by continuously monitoring the patient's physical activity, along with the assessment of pulmonary symptoms and lung function. A key question is: can investigators find indicators that provides support for early intervention before severe symptoms arise.

The patient carries a smartphone that records physical activity real-time, daily lung function measures, lung disease related symptoms, and use of medication.

The experimental phase, the first part of the project, covers 25 COPD patients followed up to 12 weeks where the primary objective is to examine and verify both new investigational methodology and technology.


Eligibility Criteria:
Inclusion Criteria:

* Female or male 40 years of age and above
* Ability to use a smartphone and Bluetooth spirometer
* Subjects having COPD
* Ongoing treatment for a recent and not completely recovered COPD exacerbation

Exclusion Criteria:

* Dominating physical disability for other reasons or not related to COPD
Progesterone Effect on Individuals Diagnoses With AD and PTSD.

This is a randomized control trial with an anticipated 36 participants diagnosed with post-traumatic stress disorder (PTSD) and comorbid alcohol dependence. Participants will be randomized to receive either progesterone (200 mg. bid) or placebo in identical looking capsules for three days.

One goal of this research study is to test if progesterone is more effective than placebo in reducing craving after exposure to trauma cues and alcohol cues in a laboratory paradigm among men and women with AD and PTSD. We hypothesize that progesterone in comparison to placebo will significantly reduce craving for alcohol in response to trauma cues alone and in combination with alcohol cues in individuals with AD and PTSD.

A second goal is to examine if there are gender differences in progesterone effects on stress and alcohol cue-induced craving. We hypothesize that the effects of progesterone on stress and craving will be stronger in women than in men. Participants will be recruited primarily through advertisement, but also through the clinical facilities at the VA and from other collaborators.


Eligibility Criteria:
Inclusion Criteria:

1. Men and women ages 21 to 60;
2. Current diagnosis of AD and PTSD;
3. Drink regularly are not in an active phase of alcohol withdrawal;
4. Not at risk for suicide;
5. Not taking regularly psychoactive drugs including anxiolytics and antidepressants;
6. For women, have regular menses every 25-35 days.

Exclusion Criteria:

1. Current SCID diagnosis of any psychotic disorder;
2. Substance dependence (other than alcohol and nicotine) in the past 30 days;
3. Current unstable medical condition;
4. Positive test results at more than one baseline appointment on urine drug screens conducted for opiates, cocaine, marijuana, benzodiazepines, and barbiturates; for women, amenorrhea, use of oral contraceptives;
5. Known allergy to progesterone or peanuts (vehicle for micronized progesterone);
6. History of thrombophlebitis, deep vein thrombosis, pulmonary embolus, clotting or Bleeding disorders, heart disease, diabetes or history of stroke.
A Study of JNJ-77242113 in Adolescent and Adult Participants With Moderate to Severe Plaque Psoriasis

The purpose of this study is see how effective is JNJ-77242113 in participants with moderate to severe plaque psoriasis.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of plaque psoriasis, with or without psoriatic arthritis, for at least 26 weeks prior to the first administration of study intervention
* Total body surface area (BSA) greater than or equal to (\>=)10 percent (%) at screening and baseline
* Total psoriasis area and severity index (PASI) \>=12 at screening and baseline
* Total investigator global assessment (IGA) \>=3 at screening and baseline
* Candidate for phototherapy or systemic treatment for plaque psoriasis
* A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test beta-human chorionic gonadotropin (beta-hCG) at screening and a negative urine pregnancy test at Week 0 prior to administration of study intervention

Exclusion Criteria:

* Nonplaque form of psoriasis (for example, erythrodermic, guttate, or pustular)
* Current drug-induced psoriasis (for example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
* A current diagnosis or signs or symptoms of severe, progressive, or uncontrolled renal, liver, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
* Known allergies, hypersensitivity, or intolerance to JNJ-77242113 or its excipients
* Major surgical procedures, (for example, requiring general anesthesia) within 8 weeks before screening, or will not have fully recovered from a surgical procedure or has a surgical procedure planned during the time the participant is expected to participate in the study
Comparison Between Bioactive Silica Graft Plus Platelet Rich Fibrin and Only Platelet Rich Fibrin Graft in Intrabony Defects With Diabetes

Various regenerative procedures used for the treatment of intabony defects.The Aim of this study is to compare the treatment outcome of bioactive silica graft with platelet rich fibrin Vs bioactive silica graft in the treatment of intrabony defects in patients with diabetes mellitus.

Platelet rich fibrin has emerged as one of the promising regenerative material.It is a second generation platelet concentrate and is defined as an autologous leucocyte-and platelet-rich fibrin biomaterial.Platelet-rich fibrin membrane consists of a fibrin 3-D polymerized matrix in a specific structure ,with the incorporation of almost all the platelets and more than half of leucocytes along with growth factors.It enhance the stabilization and revascularization of the flaps and grafts.

Bioactive silica graft (Novabone dental putty )is being used for regenerative procedures is a premixed composite of bioactive calcium -phospho-silicate particulate which is composed solely of elements that exist naturally in normal bone (ca,p,na,si,o) and an absorbable binder which is a combination of polyethylene glycol and glycerine.Treatment of intrabony defects with bioactive silica graft has led to clinically and statistically significant probing depth reduction ,relative attachment level gain and radiographic osseous defect fill.

Eligibility Criteria:
Inclusion Criteria:

* Two or three walled defects With relative clinical attachment loss ≥3mm Probing depth≥5mm Patients with known diabetes(Type 2 hbA1c 6 to 7.4)

Exclusion Criteria:

* One wall defects Other systemically compromised patients Non- compliant patients Individuals allergic to medication Pregnant or lactating mothers Smokers
Evaluation of the Phased Radio Frequency Ablation System

VICTORY AF is an IDE, prospective global, multi-center, single arm, controlled, unblinded, investigational clinical study. The purpose of this clinical study is to evaluate the risk of procedure and/or device related strokes in subjects with persistent or long-standing persistent atrial fibrillation (AF) undergoing ablation with the Phased RF System.


Eligibility Criteria:
Inclusion Criteria:

* History of symptomatic persistent or long-standing persistent atrial fibrillation
* Failure of at least one anti-arrhythmic drug

Exclusion Criteria:

* Structural heart disease
* Prior ablation in left atrium for AF
* Known sensitivities (or allergy) to heparin, warfarin, contrast media
* Contraindicated for MRI
* Invasive cardiovascular procedure performed or planned within 3 month period of ablation procedure
Multiple Arterial Phase Computed Tomography Examination to Improve Detection of Tumors in the Liver and Pancreas

To examine inter-subject variations of optimal late arterial phase contrast-enhancement defined as the greatest difference in contrast attenuation of hepatocellular carcinoma (HCC) compared to background liver parenchyma resp. pancreatic lesions compared to pancreatic parenchyma. To evaluate which time-points best depict an optimal late arterial phase.

Background: Many previous studies have analyzed and proposed different strategies to achieve optimal contrast timing and enhancement in the late arterial phase to best depict arterialized lesions in the liver and hypoattenuating tumors in the pancreas(1-12). But even with the use of state-of-the-art protocols, inter-subject variations of optimal contrast enhancement in liver lesions and pancreas parenchyma are still very common. The aim of this study is to first analyze these alterations and to, secondly, use the newly gained knowledge to design a dose-neutral multiple arterial phase protocol. An optimized arterial phase protocol might improve the detection of hepatocellular carcinoma (HCC) and/or pancreatic adenocarcinoma.

Purpose: To measure when the greatest difference in attenuation occurs in HCC compared to background liver parenchyma resp. in pancreatic lesions vs. pancreatic parenchyma. To describe the inter-subject variation of these enhancement times and to evaluate at which time-points an optimal late arterial phase can be achieved. The investigators will use the perfusion scanning technique, bolus-tracking and high body-weight-adjusted volumes of contrast media (CM).

Anticipated results: The aim is to find the best time points for optimal CM-enhancement in HCC lesions and pancreas parenchyma. The results will show the extent of the inter-subject temporal enhancement differences and will be used to design an optimized late arterial phase protocol for clinical practice and future studies.

Eligibility Criteria:
Inclusion Criteria:

* patients, who are scheduled for a multiphasic liver or pancreas CT because of known or suspected malignancy in the liver or pancreas.

Exclusion Criteria:

* below 50 years of age, contrast media allergy or decreased kidney function
Time to Protein Target Using a High Whey Protein Enteral Nutrition in Critically Ill Patients

This study evaluates the feasibility of a high whey-protein enteral nutrition formula in 20 ventilated ICU patients. The primary endpoint of study is the feasibility to attain the individualized protein target (≥1.2 g/kg ideal body weight/day) 96-hours after ICU admission. Secondary endpoints include tolerance and efficacy in terms of the amino acid response in blood.

In the present pilot study, the investigators will use a high whey-protein nutrition formula during the first four days of ICU admission. The reason for using a high protein nutrition is that the investigators previously found that an early high protein intake in non-septic non-overfed patients was associated with lower hospital mortality (Weijs PJM et. al., Critical Care 2014,18). Furthermore, during the first days of critical illness tolerance to full enteral nutrition is often diminished. The use of a high protein nutrition will facilitate an early high protein intake.

The whey protein is hydrolysed. Hydrolyzation of protein prevents coagulation and subsequent solidification in the digestive tract and therefore promotes efficient absorption of the protein. Of all nutrition proteins, whey protein has the largest leucin content. Leucin is crucial for muscle protein synthesis. (Meyer RF, et.al.: BMC Gastroenterol 2015, 15), (Marik PE: Ann Intensive Care 2015,5:51)

Our previous observational data also showed that early overfeeding was associated with higher mortality, while an intake of 80-100% of measured energy expenditure at day 4 of ICU admission was associated with lower mortality. (Weijs PJM et. al., Critical Care 2014, 18)

Therefore, the energy target during the first four days will be 90% of the measured Energy Expenditure (EE). To optimize energy intake, the investigators will measure EE by metabolic monitoring (Deltatrac®, Datex, Helsinki, Finland), If metabolic monitoring is not available, the investigators will assess EE from the ventilator derived VCO2 (8.19\*VCO2). (Stapel S, et.al., Critical Care 2015,19:370)

Eligibility Criteria:
Inclusion Criteria:

* Admission to the intensive care unit
* Age \>18 years
* Mechanical ventilation
* Expected intensive care stay of four days or longer

Exclusion Criteria:

* Contraindication for enteral nutrition (gut ischemia, obstruction or perforation)
* Expected intolerance for enteral nutrition (paralytic ileus)
* Inability to start enteral nutrition within 24-hours due to logistic reasons (i.e. surgery or other interventions)
* Short bowel syndrome
* Child C liver cirrhosis or acute liver failure
* Dialysis dependency
* Requiring other specific enteral nutrition for medical reason
* Extensive treatment limitations
* Written deferred patient or proxy consent is not obtained
* Participation in another intervention study
* Inability to measure energy expenditure (pulmonary air leakage)
Fascia Release Techniques Applied to Plantar Flexor Muscles and Acute Efficacy of Kinesio Taping

The aim of this study; The aim of this study is to examine the effects of kinesio taping technique and percussive massage technique applied to plantar flexor muscles on proprioception, balance and flexibility in healthy individuals.

The sample of the study will consist of healthy individuals who have not had any discomfort or surgical operation related to the lower extremity in the last 6 months. The demographic information of the individuals who agreed to participate in the study will be recorded and their written consent will be obtained. Participants will be divided into 2 groups as kinesio taping and Percussive Massage groups by randomization method. The dominant lower extremities of both groups will be applied. The Percussive Massage group will be applied to the posterior part of the sural fascia for 5 minutes, 3 times a week, including the plantar flexor muscles. In the kinesio taping group, taping will be done in accordance with the fascia correction technique, including the plantar flexor muscles, and it will be requested to stay for 3 days. Both groups will be evaluated before and after the application. Joint position sense test will be used to evaluate proprioception. In the evaluation of balance, the one-leg standing test will be considered. In the evaluation of flexibility; The flexibility of the hamstring, gastrocnemius, and plantar fascia will be examined. The Straight Leg Lift Test will be performed to look at the flexibility of the hamstring muscle. Pre- and post-intervention data were statistically analyzed and compared.

Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in the study
* Being between the ages of 18 and 60

Exclusion Criteria:

* Injury or surgery involving the lower extremity in the last 6 months
* having had an operation
* Malignancy, aneurysm, fever, infection, fracture, osteoporosis, rheumatoid arthritis, diabetes,
* coagulation disorder etc. myofascial release techniques are contraindicated
* have ailments
* Having any disorder that will affect balance
Efficacy and Safety of the Alena App as a Treatment for Social Anxiety Disorder

The present study is a randomised controlled trial that seeks to investigate the efficacy and safety of the Alena app as a treatment for social anxiety disorder.

This will be a 10-week web-based parallel-group unblinded randomised controlled trial with an 8-week intervention period and a 2-week follow-up post-intervention. Participants will be randomly allocated to receive access to the Alena app or to a wait list control group, in a 1:1 ratio. The Alena app primarily comprises CBT-based therapy for social anxiety based on the Clark and Wells model, as well as cognitive assessments, calming exercises and a community forum.

Eligibility Criteria:
Inclusion criteria:

* Scored over 30 on the SPIN (indicating at least moderate social anxiety)
* Aged 18 or over
* Fluent in English
* Has access to a smartphone (iOS or Android) and the internet
* UK resident

Exclusion criteria:

* Currently receiving therapy for their mental health
* Mental health medication has changed (dosage or presence) in the last 8 weeks
* Scores over 7 on the AUDIT-C and/or yes on either drug dependence question taken from the DUDIT (indicating drug or alcohol abuse)
* Previous experience with the Alena app through prior studies or user testing