cyrilzakka/clinical-trials huggingface dataset:
Exercise as an Adjunct Therapy to Reduce Blood Pressure in Chronic Kidney Disease

The general objective of the study is to investigate the effect of regular aerobic exercise on resting and 24-hr blood pressure levels in men and women with stage 3-4 kidney disease and hypertension.


Eligibility Criteria:
Inclusion Criteria:

* • Non-diabetic and \>18 years of age

  * Diagnosed kidney disease with associated hypertension:
  * Non-nephrotic range proteinuria at diagnosis
  * No active glomerular disease or concomitant systemic inflammatory disease (e.g. lupus)
  * Systolic blood pressure \>130 and/or diastolic blood pressure \>80 mm Hg (on medication)
  * An estimated glomerular filtration rate of between 60 ml/min and 15 ml/min.
  * Individuals must be able to provide informed consent
  * Perform walking exercise training on a treadmill
  * Be able to participate in a 12-week supervised exercise program.

Exclusion Criteria:

* Currently participating in a formal exercise program
* Diabetes, active glomerular disease, or systemic inflammatory disease
* Requiring dialysis
* Have an Hematocrit \<27%
* Uncontrolled hypertension (\>200/110mmHg)
* Peripheral vascular disease.
* An inability to understand English or give consent. Other exclusion criteria are: any contraindications to exercise testing or training as indicated by the American College of Sports Medicine guidelines such as: Unstable coronary heart disease and symptomatic heart failure, exercise capacity limited by health problems such as angina, severe arthritis, or extreme dyspnea on exertion, progressive neuromuscular disease, pulmonary disease, or having undergone a coronary revascularization within the past 6 months prior to enrollment.
A Study of LY3484356 in Healthy Female Participants

The main purpose of this study is to evaluate the amount of LY3484356 that is found in the blood stream and how long the body takes to get rid of it when given with and without food. Participants are healthy females of non-childbearing potential. The study will also evaluate the tolerability and safety of LY3484356 by collecting the information about any side effects that may occur. The participant's involvement with the study will last approximately 27 days, not including screening.


Eligibility Criteria:
Inclusion Criteria:

* Participants who are overtly healthy as determined by medical assessment
* Body mass index (BMI) within the range 18.0 to 35.0 kilograms per meter squared (kg/m²)
* Female participants of non childbearing potential. This includes females who are not pregnant, non-lactating and either: Infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy or bilateral salpingectomy, bilateral tubal ligation, or bilateral tubal occlusion), or alternate medical cause/congenital anomaly (for example, Müllerian agenesis) or postmenopausal

Exclusion Criteria:

* Have a history or presence of cardiovascular (eg, symptomatic bradycardia with resting heart rate of \<60 beats per minute), respiratory, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
* Show evidence of hepatitis B, evidence of hepatitis C and/or have evidence of human immunodeficiency virus (HIV) infection
* Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, within 30 days prior to dosing
* Use or intend to use medications that inhibit or induce CYP3A4 within 14 days prior to dosing until completion of the follow-up visit
* Smoke more than 10 cigarettes or use the equivalent tobacco, smoking-cessation products, nicotine-containing products, or e cigarettes (nicotine and non nicotine) per day
Safety/Efficacy of Bromfenac Ophthalmic Solution for Ocular Inflammation and Pain Associated With Cataract Surgery

The primary objective of this study is to investigate the efficacy and safety of bromfenac ophthalmic solution for treatment of ocular inflammation and pain in subjects who undergo cataract extraction and intraocular lens implantation.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled for unilateral cataract surgery with no other ophthalmic surgical procedures planned during cataract surgery
* Agree to return for all required visits
* Agree to avoid disallowed medications

Exclusion Criteria:

* Known hypersensitivity to bromfenac and salicylates
Comparison of Biodegradable & Metal Plates for Fixing Ankle Fracture

A randomised, prospective clinical investigation to compare post-operative fracture healing and complication rate after the fixation of ankle fractures using the Inion OTPS FreedomPlateTM Biodegradable Fixation System versus conventional stainless steel metal screws and plates.

The objectives of the investigation are

* to compare post-operative fracture healing (union rates, time-to-union), and the complication rates (hardware failure, infection) between the two Plating Systems (biodegradable INION OTPS FreedomPlateTM vs. Stainless Steel 3.5 Reconstruction or DCP plate, or 1/3 Semitubular plates) at the clinical setting of Ankle fractures
* to study the safety of the clinical application of the biodegradable plating system of Inion OTPS FreedomPlateTM at the acute Ankle fracture setting.


Eligibility Criteria:
Inclusion Criteria:

1. Patient is willing and able to understand, sign and date the study-specific, Institutional Review Board/Ethics Committee approved patient informed consent and applicable privacy regulations.
2. Patient must require surgical treatment of a ankle fracture, with a distal fibular (i.e., lateral malleolus) fracture (isolated, closed, unilateral, non-comminuted) including either instable/dislocated Weber class B or any Weber class C fracture that cannot be anatomically reconstructed accurately without open procedure, or bimalleolar fracture with lateral malleolus fracture (as described above) and medial malleolus fracture (closed, unilateral, non-comminuted), or trimalleolar fracture with lateral and medial malleolus fractures as described above and posterior malleolus fracture with less than ¼ of the articular surface fractured
3. Fresh/acute fractures (seen within seventy-two hours of the injury)
4. Aged between 18 to 60 years
5. Skeletally mature
6. Willingness to accept randomisation either to the test or control group
7. Willingness and ability to comply with all investigation procedures pre- and post-operation.

Exclusion Criteria:

1. Contraindications of operative internal plate fixations
2. Contraindications for the Inion OTPS FreedomPlateTM Biodegradable Fixation System:

   * active or potential infection
   * patient's conditions, including limited blood supply, insufficient quantity or quality of bone, and where patient cooperation cannot be guaranteed (e.g., alcoholism, drug abuse)
   * high-load bearing applications
3. Multiple trauma, head injury, bilateral lower extremity fractures, upper extremity fractures
4. Any concomitant painful or disabling disease of the lower limb that would interfere with evaluation of the affected ankle
5. Previous ankle fracture
6. Patients who most likely will not learn to walk with crutches (e.g., due to being severely overweight)
7. Bone malignancy
8. Osteomyelitis
A Research Study to Look at Long-term Treatment With a Medicine Called NNC6019-0001 for People Who Have Heart Failure Due to Transthyretin Amyloidosis

This study will test a medicine, NNC6019-0001, for people who have a heart disease due to TTR amyloidosis. It will look at how safe this medicine is in the long term and if it can reduce symptoms of a heart disease due to TTR amyloidosis, such as heart failure. It is an extension to a study called "A research study to look at how a new medicine called NNC6019-0001 works and how safe it is for people who have a heart disease due to TTR amyloidosis". Only participants who have completed that study will be invited for this new study. Participants will get NNC6019-0001, regardless of whether they got placebo or NNC6019-0001 in the first study. The study will last for up to 157 weeks (36 months/3 years).


Eligibility Criteria:
Inclusion Criteria:

* Completed study intervention in NN6019-4940 and attended the last study visit (week 64; visit 16), and no later than 12 weeks after visit 16.
* Expected to be on stable doses of cardiovascular medical therapy 6 weeks prior to the enrolment visit.

Exclusion Criteria:

* A prior solid organ transplant.
* Presence or history of malignant neoplasm (other than basal or squamous cell skin cancer, in-situ carcinomas of the cervix, or in-situ/high grade prostatic intraepithelial neoplasia (PIN) or low-grade prostate cancer) within 5 years before screening.
* Current treatment with calcium channel blockers with conduction system effects (e.g., verapamil, diltiazem). The use of dihydropyridine calcium channel blockers is allowed. The use of digoxin will only be allowed if required for management of atrial fibrillation with rapid ventricular response.
* Body weight greater than (\>) 120 kilograms (kg) (264.6 pounds \[lb\]) at screening.
Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Exploratory Efficacy of Nimacimab in Patients With Diabetic Gastroparesis

This is a single blind phase 2a study to evaluate the safety, tolerability, pharmacokinetics, and exploratory efficacy of nimacimab in patients with diabetic gastroparesis.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with type 1 or type 2 diabetes
* Diagnosed with diabetic gastroparesis, defined by:

  1. 3 month past or current history of symptoms of gastroparesis (e.g. nausea, vomiting, bloating, abdominal pain, or feeling full earlier than normal after eating)
  2. Screening or historical scintigraphy (3 years prior to screening) with \> 20% of solid contents retained at 4 hours.
* BMI \>= 20.0 and \< = 50.0 kg/m2

Exclusion Criteria:

* Participants on prokinetic therapy should have these medications withdrawn at least 7 days prior to any study scintigraphy exam and at least 7 days prior to the first dose through Day 15 of treatment.
* Participants with any active prokinetic device are excluded, unless device is turned off for at least 7 days prior to any study scintigraphy exam and at least 7 days prior to the first dose through Day 15 of treatment.
* Participants who are currently participating in or have participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.
* Participants with uncontrolled diabetes. Participants with controlled diabetes are allowed (insulin is allowed). HbA1c\>9.9% at screening are excluded.
Getting To Implementation: Improving Cancer Screening for Veterans

Gastrointestinal cancers such as colon cancer and liver cancer cause many deaths in the US. Testing could catch these cancers early, helping people live longer. The goal of this study is to compare two different ways of getting more people tested for these cancers: 1) by directly reaching out to the people who need testing or 2) by helping providers fix issues that hold up testing.

The main question it aims to answer is: how should healthcare systems go about choosing one or the other?

Researchers will look at cancer testing rates over time at sites that are trying these different approaches. They will also survey and interview participants from these sites.

Researchers will conduct two hybrid type 3, cluster-randomized trials to compare the effectiveness of Patient Navigation (PN) and Implementation Facilitation (IF) on hepatocellular cancer (HCC) and colorectal cancer (CRC) screening completion. Trials will enroll 24 sites for the HCC arm and 32 sites for the CRC arm, passively enrolling and cluster-randomizing Veterans by their site of primary care. Multi-level implementation determinants (i.e., barriers and facilitators), preconditions, and moderators will also be evaluated pre- and post-intervention, using Consolidated Framework for Implementation Research (CFIR)-mapped surveys and interviews of Veteran participants and provider participants. Comparing findings in the two trials will allow researchers to understand how the barriers and strategies operate differently for a one-time screening in a relatively healthy population (CRC) vs. repeated screening in a more medically complex population (HCC).

Eligibility Criteria:
Inclusion Criteria:

1. Veterans:

   * ≥18 years of age
   * Enrolled in Veterans Health Administration (VA)
   * Have ≥1 VA encounter in the prior 18 months
   * Hepatocellular cancer (HCC) screening subgroup: Diagnosis of cirrhosis in electronic medical record
   * Colorectal cancer (CRC) screening subgroup: ≥45 years of age, positive fecal immunochemical test (FIT) (or other screening stool test) in the last 18 months
2. Providers:

   * Healthcare provider or related staff at participating VA site or engaged in CRC or HCC screening pathways in an included VA site (e.g., scheduling)
   * ≥18 years of age

Exclusion Criteria:

1. Veterans:

   * \<18 years of age
   * Not enrolled in VA
   * No VA encounters in the prior 18 months
   * Limited life expectancy (\< 6 months), defined as having a code for hospice
2. Providers:

   * Members of the study team will not participate, even if their sites are recruited
Intervention to Promote Survivor Resilience and Adjustment: Efficacy and Sustainability

The aims of this traumatic brain injury (TBI) study are:

1. to evaluate the short and long-term efficacy of two structured outpatient intervention programs, Resilience and Adjustment Intervention (RAI) vs. RAI with follow up booster sessions (RAI+) on resilience
2. to evaluate the short and long-term impact of intervention on emotional well-being and postinjury adjustment with the RAI vs. the RAI+
3. to evaluate the short and long-term impact of the RAI and the RAI+ on abilities including problem solving, communication, and stress management
4. to determine if demographic, lifestyle, injury, or treatment response information can predict maintenance of gains

Participants will be assigned to either of two treatment groups: (1) Resilience and Adjustment Intervention (RAI), or (2) RAI+. After randomization, a second appointment will be scheduled. All participants will begin the 7-session treatment during their second appointment. The intervention consists of seven 60-minute sessions scheduled over seven weeks (see attached RAI Implementation Manual). The intervention will be implemented by experienced, licensed therapists (Ph.D. level Interventionists). Participants will be randomly assigned to one of the therapists.

The RAI and RAI+ groups will both complete the post-treatment measures immediately after the seventh treatment session and then 3, 4, and 9 months later. Data collection at 3, 4, and 9 months post-treatment will be completed via phone.

Furthermore, the RAI+ group will complete 3 booster sessions, spaced approximately 7-10 days apart, beginning 3 months after completion of the seventh treatment session (booster sessions will occur between the 3 and 4 month data collection described above).

Data will be analyzed to identify any therapist effects, as well as treatment effects. For the RAI and RAI+ groups, demographic, injury severity, and history information will be collected at intake using standard procedures and protocols. All participants will complete the 4 outcome measures (Connor-Davidson Resilience Scale, CD-RISC; Mayo Portland Adaptability Inventory-4, MPAI-4; 13 Item Stress Test; and Brief Symptom Inventory-18, BSI-18) at 5 time points (intake, post-treatment, and 3, 4 and 9 month follow-up).

Eligibility Criteria:
Inclusion Criteria:

* Mild, moderate, or severe TBI defined as: damage to brain tissue caused by an external mechanical force as evidenced by loss of consciousness due to brain trauma, post-traumatic amnesia (PTA), skull fracture, or objective neurological findings that can be reasonably attributed to TBI on physical examination or mental status examination.
* At least 3 months post-TBI.

Exclusion Criteria:

* Active substance abusers (e.g., intoxicated at arrival to intake).
* Individuals at imminent risk of psychiatric hospitalization, or in imminent danger of hurting themselves or others, as judged by the investigators, will be excluded from the study.
Standard Cut Rate 27-Gauge System Versus Ultrahigh-Speed 27-Gauge System in Macular Surgery

The purpose of this study is to compare the efficiency and safety of ultrahigh-speed cut rate 27-gauge system (27+®GA HYPERVIT® Vitrectomy Probe (Alcon Laboratories, Fort Worth, TX, USA)) and standard cut rate 27-gauge vitrectomy system (27+®GA Advanced ULTRAVIT® Vitrectomy Probe (Alcon Laboratories, Fort Worth, TX, USA)).

During the last few decades, there have been dramatic changes in vitreoretinal surgery field with improvements in the performance of surgical retina equipment. As the innovation trend has been moving toward the smaller instrument calibers, the 27-gauge vitrectomy system has been developed. However, the vitrectomy system with the smaller calibers have limitations such as reduced instrument rigidity, limited availability of instrumentation, and decreased flow rate. To overcome these limitations, active developments have been ongoing to increase vitreous cutting speed, enlargement of the cutting port size, and enlargement of inner shaft to enable higher flow rates. Especially, the ultrahigh-speed cutter with improved cutting speed has the advantage of enabling safer vitrectomy because the faster cutting speed reduces retinal movement and minimizes the risk of iatrogenic retinal breaks. However, ultrahigh-speed cutting has a limitation in that it can reduce the flow rate through the vitreous cutter as it affects the duty cycle (percentage of time the cutter port is open relative to the complete cutting cycle). Therefore, the duty cycle of ultrahigh-speed cutter has also been improved so as not to delay the time for vitrectomy.

The investigators would like to evaluate the efficiency and safety of vitrectomy using a recently released ultra high-speed cut rate 27-gauge system (27+®GA HYPERVIT® Vitrectomy Probe (Alcon Laboratories, Fort Worth, TX, USA)) and a standard cut rate 27-gauge system (27+®GA Advanced ULTRAVIT® Vitrectomy Probe (Alcon Laboratories, Fort Worth, TX, USA)) by comparing the duration of vitrectomy and the rate of complications.

Eligibility Criteria:
Inclusion Criteria:

* All consecutive eyes requiring macular surgery (i.e. epiretinal membrane, vitreomacular traction etc.) that underwent 27-gauge vitrectomy at Seoul National University Bundang Hospital (SNUBH) from September 2022 to August 2023. Patients will be randomized to receive 27-gauge vitrectomy with 20,000 cpm probes (20K group) or 27-gauge vitrectomy with 10,000 cpm probes (standard group).

Exclusion Criteria:

1. Previously vitrectomized eye
2. Trauma cases
3. Proliferative diabetic retinopathy with fibrovascular membranes
4. Retinal detachment with proliferative vitreoretinopathy
5. Macular hole
6. Endophthalmitis
7. Inability to consent for procedure
A Randomised Control Trial of Integrative Cognitive Behavioural Therapy for Alopecia

This Randomised Control Trial (RCT) aims to test a novel Alopecia-tailored, protocolled, integrative individual psychological intervention offered to patients with enduring Alopecia. The pilot study aims to assess the impact of the intervention on 8 patients, by assessing changes in their psychological and physical symptoms (stress, anxiety, depression, quality of life, scalp hair, and other bio-markers) compared to 7 patients in the wait-list control group.

Alopecia is a stress-related auto-immune skin condition that results in hair-loss on the scalp and around the body. This pilot RCT aims to test a newly developed Alopecia-specific, psychological intervention with 8 patients diagnosed with enduring Alopecia. The intervention is an Integrative Cognitive Behavioural Therapy, implemented through a protocolled programme entailing 12 weeks of hourly individual sessions. The trial will be delivered at The Dermatology Department at the Royal Free Hospital in Hampstead, London. The pilot study aims to evaluate the impact of the intervention on patients' psychological and physical symptoms (stress, anxiety, depression, quality of life, scalp hair, and other bio-markers) compared to the wait-list control group.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Alopecia received by medical profession over 1 year prior to beginning trial
* Fluent in Written and Verbal English

Exclusion Criteria:

* Another more dominant skin condition
* Another more dominant severe and enduring mental illness
* Women who are pregnant
* Learning difficulties, brain injuries or dementia
* Drug and alcohol dependency
* Received therapy in the last year
Evaluation of Lung T1-MRI in Pediatric Cystic Fibrosis Patients

In this observational study, the investigators evaluate the sensitivity of T1-MRI to identify lung perfusion changes in pediatric patients with CF (age = 6-11) before and after initiating FDA-approved Trikafta therapy. The investigators compare these Lung T1 MRI assessments (% Normal lung perfusion) to currently best-available assessments of lung function in CF patients (i.e., MBW (LCI( and Spirometry (FEV1 % Predicted).

This is a prospective study with 3 study visits to evaluate the utility of Magnetic Resonance Imaging (MRI) and clinical lung function assessments to detect changes in Cystic Fibrosis (CF) patients before and after administration of the FDA-approved Trikafta therapy. The 3 study visits include:

Visit 1: Before starting Trikafta Visit 2: 3 months from start of Trikafta Visit 3: 6 months from start of Trikafta

Along with the clinical assessments (MBW and Spirometry), all participants will undergo an MRI scan of the lungs to generate quantitative lung T1 maps. The investigators will compare the lung T1 MRI (% Normal Lung Perfusion) to Multiple Breath Washout (LCI) and spirometry (FEV1 % Predicted) as methods to assess lung changes with administration of Trikafta. The investigators will obtain additional clinical assessments from participant's medical records.

This is a multi-site study involving 3 sites.

Eligibility Criteria:
Inclusion Criteria:

• Male or female individuals with a diagnosis of cystic fibrosis and have at least one copy of the F508del mutation.

Exclusion Criteria:

* Subject who cannot hold their breath for up to 15 seconds.
* Subjects who are pregnant.
* Subjects with MRI contraindication (e.g., heart pacemaker, heart defibrillator, metal in within the body.