cyrilzakka/clinical-trials huggingface dataset:
LATAM LOWERS LDL-C

This is an open label, patient-level 1:1 randomized clinical trial in a multi-country study aiming to evaluate the real-world impact of inclisiran + Usual Care (UC) vs UC alone on LDL-C lowering, patient-reported outcomes, and healthcare resource utilization in an in-hospital population of patients, admitted during the acute setting, stabilized and before discharge, following an acute cardiovascular event.

The primary objective is to evaluate the impact of inclisiran plus usual care on LDL-C lowering versus usual care after acute MI, confirmed ischemic stroke, or urgent coronary revascularization.

The secondary objective is to compare the LDL-C reduction of both arms in target population.

Study completion for an individual participant is defined as when the participant finishes the last visit (day 330) and any assessments associated with that visit.

Eligibility Criteria:
Inclusion Criteria:

* Admitted for MI (Type 1 NSTEMI or STEMI), urgent (i.e., non-elective) coronary revascularization (PCI or CABG) or confirmed ischemic stroke.
* Stable patient: Patient will be considered stable if they did not suffer cardiac arrest at presentation or if in the last 24 hours before randomization:

  * Was not in cardiogenic shock.
  * Did not required invasive hemodynamic, inotropic or vasopressor support.
* Participants are required to be eligible for receiving inclisiran in accordance to approved local label.

  * Of note, patients who are initiated on statin therapy during the same hospitalization will not be excluded, as we expect a proportion of patients at baseline to not yet be on statin therapy in this real-world study. This will enhance the generalizability and pragmatic aspects of the study. However, because initiation of statin therapy at or near the time of enrollment could impact the primary outcome (if there is imbalance between the arms, or if there is differential stopping of statin therapy between the arms), we will stratify randomization by this factor and will pre-specify analyses in those who have vs. have not been initiated on statin therapy during the same hospitalization.

Exclusion Criteria:

* Currently on PCSK9i therapy (within last 3 months)
* Current participation in another clinical study with another study drug
* Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver at the Baseline Visit
* Pregnant or nursing (lactating) women
* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception
Gluteus Medius Dry Needling and Ankle Instability

Randomized clinical trial in individuals with chronic ankle instability. Main outcomes were as follows: pain intensity, pressure pain threshold, lower limb balance and range of motion. The sample will be divided in two groups: 1) dry needling at the gluteus medius trigger point (intervention). 2) dry needling 1,5 cm from the gluteus medius trigger point (control).

Inclusion criteria will be: individuals with chronic ankle instability, 20 to 50 years old. Exclusion criteria: any lower limb disease, fractures, infections, pregnancy, received any treatment in the previous 3 months.

Initially, the base measurements were as follows: paint intensity, pressure pain threshold at the gluteus medius trigger point, ankle range of motion and balance of the lower limb.

Once baseline measurements will be taken, the same evaluations will be performed at 4 weeks from the start.

Eligibility Criteria:
Inclusion Criteria:

* individuals with chronic ankle instability, 20 to 50 years old.

Exclusion Criteria:

* any lower limb disease, fractures, infections, pregnancy, received any treatment in the previous 3 months.
A Multicenter Observational Study to Evaluate the Effectiveness of Patisiran in Patients With Polyneuropathy of ATTRv Amyloidosis With a V122I or T60A Mutation

To evaluate the effectiveness of patisiran in patients with ATTRv amyloidosis with polyneuropathy who have a V122I or T60A mutation.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with ATTRv amyloidosis with polyneuropathy, with a documented V122I or T60A mutation
* PND score of I-IIIB at baseline.
* Exposure to commercial patisiran in one of the 3 cohorts:

  * Prospective Cohort: Naive to patisiran treatment at the time of enrollment with intention to initiate treatment with patisiran.
  * Mixed cohort: Currently on commercial patisiran therapy for less than 12 months at study enrollment.
  * Retrospective cohort: Exposed to commercial patisiran treatment for at least 12 months prior to study enrollment, regardless of current treatment status at enrollment.

Exclusion Criteria:

* New York Heart Association (NYHA) heart failure classification ≥3
* Karnofsky Performance Status (KPS) \<60%
* Unstable congestive heart failure (CHF)
* Known primary amyloidosis (AL) or leptomeningeal amyloidosis
* Prior major organ transplant
* Previously received patisiran
* Previous treatment with a TTR silencing therapy
Incentivized Smoking Cessation for Diabetics

This pilot study aims to test the feasibility of providing incentives to patients with T2D contingent on remote biochemical verification using a smartphone carbon monoxide (CO) monitor. The investigators will use an ecological momentary assessment (EMA) smartphone application and CO sensor to monitor urges to smoke, stressors, smoking behaviors, and to validate continuous abstinence throughout the intervention. Two different contingency management structures will be explored to investigate the length of time incentives need to be offered.

Individuals with type 2 diabetes (T2D) are at an increased risk of many cancers, though the causal link is not well understood. Continuing to smoke after a T2D diagnosis is also associated with accelerated progression of microvascular and macrovascular complications and an increased risk of death. Smoking cessation is recommended as a standard treatment for diabetes. However, both patients and providers are faced with other challenging lifestyle changes and disease management processes, which lead to greater difficulty in quitting.

Contingency management, or a method of providing financial incentives contingent upon positive behaviors, has shown promise for improving adherence to medication among diabetics and for improving smoking cessation in other populations. This approach could offer an innovative and scalable means of increasing abstinence in this group, ultimately reducing their risk of cancer. This is a multicenter pilot randomized controlled trial that will recruit participants in Oklahoma and in Strathclyde, Scotland.

This pilot study aims to test the feasibility of providing incentives to patients with T2D contingent on remote biochemical verification using a smartphone carbon monoxide (CO) monitor. The investigators will use an ecological momentary assessment (EMA) smartphone application and CO sensor to monitor urges to smoke, stressors, smoking behaviors, and to validate continuous abstinence throughout the intervention. Two different contingency management structures will be explored to investigate the length of time incentives need to be offered. Qualitative semi-structured interviews will be used to explore the patient and provider acceptability of an incentive-based cessation program, any unintended consequences and possible differences between UK and US health settings.

The results of this research will inform the feasibility of carrying out a randomized controlled trial of this intervention. The ultimate aim is to develop an effective intervention that could be scaled to the T2D population at large, which reduces cancer risk and improves disease outcomes among a high-risk group.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 to 75
* Type 2 diabetes diagnosis greater than 1 year prior to enrollment
* Currently smoking at least 5 cigarettes per day
* Self-reported quit attempt in past 12 months

Exclusion Criteria:

* Unwilling to make a quit attempt
* Unable to use smartphone iCO monitor following training session
The Effect of Perineural Dextrose Injection in Patients With Ulnar Neuropathy at the Elbow

Ulnar neuropathy at the elbow (UNE) is the second most common neuropathy and occurs after recurrent or elongated elbow flexion. Diagnosis of UNE depends on clinical symptoms, physical examination, and electrophysiological findings. Imaging methods such as ultrasonography (USG) and magnetic resonance imaging show cross-sectional area and echogenicity of ulnar nerve and give information about to surrounding structures around the ulnar nerve. In mild and moderate cases, conservative treatments are administered up to 6 months, who do not benefit from conservative treatment are referred to surgery. There are not many options for conservative treatment. Activity modification, nerve gliding exercises and night splints are conservative treatment methods. Steroid injection is no longer recommended. Perineural dextrose injection is applied in tendinopathies and entrapment neuropathies (especially carpal tunnel syndrome). In the literature, there is no study showing effect of perineural dextrose injection in patients with UNE. The investigators design a randomized, double-blind, controlled trail to evaluate the effect after ultrasound-guided perineural injection with 5% dextrose in patients with UNE.

After obtaining written informed consent, patients of clinically diagnosed with UNE were randomized into intervention and control group. Participants in intervention group received one-session ultrasound-guided perineural injection with 5% dextrose and control group received one-session ultrasound-guided perineural injection with normal saline. No additional treatment after injection through the study period. The primary outcome is visual analog scale (VAS) and secondary outcomes include Quick-DASH (Disabilities of Arm, Shoulder and Hand), cross-sectional area (CSA) of the ulnar nerve, motor nerve conduction velocity and distal latency of the ulnar nerve. The evaluation was performed pretreatment as well as on the 2nd week, 1st and 3rd month after the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18-65 year-old.
* Neuropathic pain on the ulnar nerve distribution area for at least 1 months
* Diagnosis was confirmed using an electrophysiological studies and ultrasonography

Exclusion Criteria:

* History of trauma to the upper extremity
* Central or peripheral neurologic disease
* Electromyography (EMG)-proven carpal tunnel syndrome, radiculopathy or any other neuropathy
* Pregnancy or any systemic disease that might cause swelling on nerves (e.g., diabetes -mellitus, renal failure, and thyroid disease)
* USG-detected bifid or trifid median nerve, persistent median artery, or space-occupying lesions
A Open-Label Drug-Drug Interaction Study of Telotristat Etiprate and Midazolam in Healthy Subjects

This study is designed to evaluate the effects of telotristat ethyl on the pharmacokinetics of midazolam in healthy male and female subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult males and females ≥18 to ≤55 years of age at Screening.
* Body mass index ≥18.0 to ≤2.0 kg/m\^2
* Acceptable vital signs at Screening: Systolic blood pressure = 90-140 mm Hg, Diastolic blood pressure = 50-90 mm Hg, Heart rate = 40-100 beats per minute
* Willingness to adhere to the restrictions outlines in the protocol
* Able to comprehend and sign the informed consent form.

Exclusion Criteria:

* Presence of any clinically significant physical, laboratory, or ECG finding that may interfere with the study in the opinion of the Investigator
* Use of any medications, herbal tea, energy drink, herbal products, or supplements
* Receipt of any investigational agent or study drug within 30 days or 5 half-lives of study start
* Receipt of any protein- or antibody-based therapeutic agent within 3 months of study start
* Prior exposure to telotristat etiprate
* Use of tobacco, smoking cessation products, or nicotine products within 3 months of study start
* History of major surgery within 6 months of study start
* History of acute narrow angle glaucoma
* History of renal disease, or significantly abnormal glomerular filtration rate (\<90 mL/min as calculated using the Cockcroft-Gault equation) at Screening
* History of hepatic disease, or significantly abnormal liver function tests
* History of any clinically significant psychiatric, renal, hepatic, pancreatic, cardiovascular, neurological, endocrinologic, hematological, or GI abnormality
* History of any active infection within 14 days prior to first dosing
* History of alcohol or substance abuse within 2 years prior to Screening
* Positive hepatitis panel (including hepatitis B surface antigen and hepatitis C virus antibody) or positive human immunodeficiency virus antibody screens
* Concurrent conditions that could interfere with safety and/or tolerability measurements
* Donation or loss of \>500 mL of blood or blood product within 3 months
* Women who are breastfeeding or are planning to become pregnant during the study
* Positive serum pregnancy test (females only)
* Positive urine screen for selected drugs of abuse and cotinine
* Consumption of alcohol within 48 hours prior to study start
* Consumption of caffeine- and/or xanthine-containing products
* Consumption of grapefruit, Seville oranges, and grapefruit- or Seville orange-containing products within 72 hours prior to study start
* Unable or unwilling to communicate or cooperate with the Investigator for any reason
* Use of any drugs or substances that are known to be substrates, inducers, or inhibitors of CYP3A4 within 30 days prior to the first dose
Effective Analgesia During Routine Immunizations

The purpose of this study is to observe and measure the analgesic effectiveness of the 5 S's (swaddling, side/stomach position, shushing, swinging, and sucking) alone and combined with sucrose, during routine immunizations at 2 and 4 month well child visits.

Study Procedure

Infants meeting inclusion criteria were identified daily by reviewing the list of patients scheduled for a 2 or 4 month well child visit at the outpatient site. The parent or legal guardian was approached prior to vaccination by the research assistant for participation in the study. If the parent/guardian accepted to participate in the vaccine study, the consenting process was performed and patients were brought to a designated examination room. Infants of parents or guardians who consented were randomly assigned to one of four study groups using pre-sealed cards. Ten cards were assigned to each group for a total of 40 cards, which were recycled with each group of 40 infants enrolled into the study. The four groups of the study included:

1. 2 ml of water 2 minutes prior to immunization and comfort by parent or guardian after Immunization (Control Group)
2. 2 ml of 24% oral sucrose 2 minutes prior to immunization and comfort by parent or guardian after immunization (Sucrose Group)
3. 2 ml of water 2 minutes prior to immunization and physical intervention using the 5 S's by researcher after immunization (Physical Group)
4. 2 ml of 24% oral sucrose 2 minutes prior to immunization and physical intervention using the 5 S's by researcher after immunization (Physical and Sucrose Group)

Eligibility Criteria:
Inclusion Criteria:

* infants with a gestational age between 32-42 weeks at delivery and post-natal age of less than 20 weeks old

Exclusion Criteria:

* acetaminophen or ibuprofen administration within 4 hours prior to immunization, current neurological disorder, known genetic anomaly, moderate to severe illness with or without fever at the time of vaccination, anaphylactic reaction to previous dose of vaccine, or if infant was previously enrolled in the study at 2 months.
Plerixafor for Stem Cell Mobilization in Normal Donors

The goal of this clinical research study is to learn if treating stem cell donors with filgrastim (G-CSF) and plerixafor (Mozobil®) can cause them to produce a higher number of blood stem cells than filgrastim by itself. Researchers also want to learn if giving both of these drugs helps donors produce enough stem cells so that only 1 apheresis procedure needs to be performed.

Researchers will study if using both drugs lowers the risk of the stem cell transplant recipients developing severe forms graft-versus-host disease (GVHD). GVHD is a condition in which transplanted tissue (such as blood stem cells) attacks the tissue of the recipient's body.

The safety and effectiveness of this drug combination will also be studied.

Filgrastim and plerixafor are both designed to help move or "mobilize" the stem cells from the bone marrow to the blood.

Stem Cell Transplant:

You will receive blood stem cells from a donor on this study. You will sign a separate informed consent for the transplant procedure.

Follow-Up Visits:

About 1, 3, and 6 months after the transplant, an extra sample of bone marrow (about 2 teaspoons) will be collected at the same time as the standard of care bone marrow aspiration/biopsy procedures. This bone marrow sample will be tested to find out how well the donated stem cells have been accepted by your body. However, you will not have a separate bone marrow aspiration/biopsy only to collect bone marrow for this testing.

When you return to the clinic at 6, 9, and 12 months for routine transplant follow-up visits, the study staff will try to get information on your health status from the clinic notes in your medical record. If this is not possible, you may receive a phone call from the study staff to check your health status. These calls will last about 10 minutes.

Length of Treatment:

You will be on study for about 1 year after the transplant (including follow-up contact by phone, if needed).

You may be taken off study early if you are not able to follow study directions or if you decide to leave the study.

This is an investigational study. Filgrastim is FDA approved for use in stem cell collection. Plerixafor is FDA approved for use in patients with multiple myeloma and non-Hodgkin's lymphoma.

Up to 30 donor and recipient pairs will take part in this study. All will be enrolled at MD Anderson.

Eligibility Criteria:
Inclusion Criteria:

1. Donor eligibility: Age \>/= 10 years.
2. Donor eligibility: Related donors who met standard eligibility criteria and are willing to participate in this study.
3. Donor eligibility: Able to provide informed consent.
4. Recipient Eligibility: Patients who are scheduled to undergo an allogeneic related transplant and whose donors consented to participate in this study.
5. Recipient Eligibility: Able to provide informed consent.

Exclusion Criteria:

1) Donors who are on anti-coagulation or anti-platelet agents are not eligible.
SNAP Fruit and Vegetable Incentive Program Digital Promotions for Farmers' Markets

The purpose of this study is to assess the impact of digital promotions of a Supplemental Nutrition Assistance Program (SNAP) fruit and vegetable incentive program on SNAP participant patronage and sales at farmers' markets. The study will analyze SNAP transactions from zip codes that receive digital promotions compared to zip codes that receive no additional promotions.

Supplemental Nutrition Assistance Program (SNAP) financial incentives for fruits and vegetables (FV) increase FV purchases and consumption with long-term implications for nutrition-related chronic disease. However, many SNAP participants are not aware of these programs, leaving them underutilized. The investigators aim to assess if digital promotions of SNAP incentive programs increase SNAP patronage and sales at farmers' markets. Eligible farmers' markets in the New England Nutrition Incentives Collaborative (NENIC) will receive digital promotions for their SNAP fruit and vegetable incentive programs on the Fresh EBT app and Facebook, randomly assigned to nearby eligible zip codes. Eligible zip codes will be randomized to receive the intervention (digital promotion) or serve as a comparison (no additional promotion) with ads running for 13 weeks (Summer 2020 market season).

Eligibility Criteria:
Inclusion Criteria:

* Farmers' markets in the New England Nutrition Incentives Collaborative (NENIC) are eligible to participate if they were data compliant in Summer 2019 (\>90% SNAP transactions reported with zip codes) and have 2 or more nearby, target zip codes.
* Zip codes are eligible if their zip code tabulation area (ZCTA) centroid is within a 7-mile (urban county) or 16-mile (rural county) travel distance of eligible NENIC farmers' market and the zip code has at least 25 active users on the Fresh EBT app

Exclusion Criteria:

* Zip code is not in Connecticut, Maine, New Hampshire, Rhode Island, or Vermont
Neuromodulation in Professional Dancers

Tendinopathy of the flexor hallucis longus (FHL), colloquially referred to as "dancer's tendinitis," is a common condition in dancers and attributed to high demand on this muscle in positions of extreme ankle plantarflexion and metatarsophalangeal (MTP) flexion and extension. Tradicional conservative treatment includes rest from pain-inducing activities including pointe work and jumping, physical therapy a focusing on movilization of the joints of the first ray and subtalar joint, and antiinflamatory medications. Unfortunately, dancer frecuently do not follow recommendations to rest due to the competitive nature of the field. Those who do not respond to conservative treatment undergo more serious interventions including steroid injections or surgery, each with additional risks and recovery time. To develop experimental protocols aimed at prevention and nonsurgical interventions are needed. Therefore, the aim of this study was To investigate the effects of one shot of low-frequency percutaneous electrical nerve stimulation (PENS) vs. one shot of transcutaneous electrical nerve stimulation (TENS) in performance of the Flexor Hallucis Longus muscle in young dancers.


Eligibility Criteria:
Inclusion Criteria:

* Female dancers
* Training at least twenty-five hours per week
* Pointe training at least five hours per week.

Exclusion Criteria:

* They had sustained an injury to their stance limb in the past year preventing dancing for at least 1 day
* Personal Psychological Apprehension Scale (PPAS) score \>37.5
* Commonly accepted contraindications to invasive phsyiotherapist technique
* Any contraindications to needling per se.
* Commonly accepted contraindications to electrotherapy
* Epilepsy.