cyrilzakka/clinical-trials huggingface dataset:
Efficacy, Tolerability, and Safety of DFN-15

Efficacy, Tolerability, and Safety of DFN-15 in episodic migraine with or without aura, being conducted at multiple centers in the United States


Eligibility Criteria:
Inclusion Criteria:

1. A history of episodic migraine, who experience 2 to 8 migraine attacks per month for at least the past 12 months, with no more than 14 headache days per month, and with 48 hours of headache-free time between migraine attacks.
2. Patients who have migraine with or without aura with onset before age 50 years
3. Report usual migraine pain of 2 (moderate) or 3 (severe) on headache pain severity scale without treatment.
4. Subjects who are willing and able to:

   1. Evaluate and record pain, migraine symptoms, and study drug effectiveness information in real-time using a subject eDiary for the duration of the study;
   2. Record each instance of the use of study drug and rescue medication in real-time using a subject eDiary for the duration of the study;
   3. Comply with all other study procedures and scheduling requirements.

Exclusion Criteria:

1. Minors, even if they are in the specified study age range
2. Medication overuse:

   1. Opioids greater than or equal to 10 days during the 90 days prior to screening
   2. Combination medications (e.g., Fiorinal®) greater than or equal to 10 days during the 90 days prior to screening (applies only if includes opioid and/or barbiturate)
   3. Nonsteroidal Anti-inflammatory Drugs or other simple medications greater than 14 days a month during the 90 days prior to screening
   4. Triptans or ergots greater than or equal to 10 days a month during the 90 days prior to screening
3. Treated with onabotulinumtoxin A (Botox®) for migraine within 4 months prior to screening. (If treated for cosmetic reasons, subjects may be included).
4. Current treatment with antipsychotics or use of antipsychotics within 30 days prior to randomization.
5. Patients who have received treatment with an investigational drug or device within 30 days of randomization, or participated in a central nervous system clinical trial within 2 months prior to randomization
6. Patients with positive screening test for human immunodeficiency virus \[HIV\], positive hepatitis B surface antigen (HBsAg), or positive hepatitis C virus \[HCV\] antibody
7. Subjects who are employees or immediate relatives of the employees of the Sponsor, any of its affiliates or partners, or of the clinical research study site.
Decreasing the Stigma of Mental Illness Among Health Science Students Through a Mentoring Program

Stigma towards people with mental health problems is a serious public health problem that limits access to treatment and social participation, in addition to being considered the main barrier to inclusion and quality of health care. This stigma also affects students and health professionals, impacting the quality of care and help seeking in mental health. In this context, it is necessary to develop innovative and effective interventions among university students to reduce this stigma and promote an inclusive and recovery-based approach.

The aim of the present research project is to analyze the effect of a mentoring program on levels of stigma and mental health help-seeking intention in psychology and nursing students. This three-session mentoring program is based on experiential learning and has been validated and adapted to our country. The mentors, professionals with lived experience in mental health, will provide knowledge and experiences to the students through direct contact sessions in the classroom, focusing especially on the processes of recovery and self-determination.

Research question: What is the effect of a mentoring program on levels of stigma and mental health help-seeking intention in health care students?

Within the dependent variables of the study are the measurement of levels of stigma and mental health help-seeking intention in students. The independent variables will be the type of group (experimental and control), age, gender and career.

Methodology: Quantitative study, including the participation of health students in the experimental and control groups. The sample size was determined using the G\*Power software. After approval by the institutional ethics committee and signature of the informed consent of the participants, the mentoring program will be implemented in the classroom. For this purpose, the levels of stigma and intention to seek mental health help in both groups will be measured using nationally and internationally validated instruments, before, after and at 4 weeks. Data analysis will be performed using a mixed ANOVA model to compare pre- and post-intervention outcomes between the two groups.

The present study will provide valuable evidence on the effectiveness of mentoring-based interventions in reducing stigma in health care students, a key group in the future provision of care for people with mental health problems. The results will also lay the groundwork for larger-scale studies to assess the impact of the intervention in other groups and settings, with the potential to significantly improve the quality of care and well-being of patients and their families.


Eligibility Criteria:
Inclusion Criteria:

* University students from health careers
* Sign the informed consent form.

Exclusion Criteria:

* Be under 18 years of age.
Postoperative Pain Alleviation in Open Heart Surgery

Effective pain relief after cardiac surgery has assumed importance with the introduction of fast track discharge protocols that requires early weaning from mechanical ventilation. Inadequate pain control reduces the capacity to cough, mobility, increases the frequency of atelectasis, and prolongs recovery. Infiltration of local anesthetics near the surgical wound has shown to improve early postoperative pain in various surgical procedures.

Magnesium is the fourth most plentiful cation in our body. It has antinociceptive effects in animal and human models of pain.

Effective pain relief after cardiac surgery has assumed importance with the introduction of fast track discharge protocols that requires early weaning from mechanical ventilation. Inadequate pain control reduces the capacity to cough, mobility, increases the frequency of atelectasis, and prolongs recovery.

A major cause of pain after cardiac surgery is the median sternotomy particularly on the first two postoperative days.

The most often used analgesics in these patients are parenteral opioids which can lead to undesirable side-effects as sedation, respiratory depression, nausea, and vomiting.

Infiltration of local anesthetics near the surgical wound has shown to improve early postoperative pain in various surgical procedures.

Magnesium is the fourth most plentiful cation in our body. It has antinociceptive effects in animal and human models of pain.

It has been mentioned in a systematic review that it may be worthwhile to further study the role of supplemental magnesium in providing perioperative analgesia, because this is a relatively harmless molecule, is not expensive and also because the biological basis for its potential antinociceptive effect is promising.

These effects are primarily based on physiological calcium antagonism, that is voltage-dependent regulation of calcium influx into the cell, and noncompetitive antagonism of N-methyl-D-aspartate (NMDA) receptors.

there is a need to evaluate and compare local magnesium with bupivacaine , in comparison to bupivacain ,and other conventional intarvenous analgesics

Eligibility Criteria:
Criteria:

Inclusion Criteria:

* 18-60 years old
* American Society of Anesthesiologists physical status II and III
* Patients scheduled for open heart valve replacement surgery with sternotomy

Exclusion Criteria:

* Emergency surgery
* Clinically significant kidney or liver disease
* Patients allergic to local anesthetic
* Patients with prolonged CPB time (\>120 min)
* Patients required intra-aortic balloon pump
Serplulimab Combined with Chemotherapy for Early-stage HR+/HER2- Breast Cancer

The neoadjuvant treatment options commonly used for HR+/HER2- breast cancer are mainly anthracycline sequential or combined with paclitaxel chemotherapy regimens. Several clinical studies have confirmed that albumin paclitaxel is more effective than solvent-based paclitaxel, and therefore, albumin paclitaxel in combination with epirubicin has also become a commonly used chemotherapy regimen in clinical practice.

The aim of this study was to explore the efficacy and safety of the Serplulimab combined with nab-paclitaxel and epirubicin in the neoadjuvant treatment of HR+/HER2- breast cancer


Eligibility Criteria:
Inclusion Criteria:

1. Age\>=18 years old
2. cT2 - cT4d, or cT1c with axillary lymph node metastasis confirmed clinically and pathologically；
3. Pathologically proven HR+/HER2- breast cancer:

   defined as:
   * positive for ER or PR (IHC nuclear staining \>1%)
   * Her-2 negative (IHC 0, 1+ without FISH, or IHC 2+ with no amplification by FISH)；
4. Has clinically measurable lesions:Measurable lesions on ultrasound, mammography, or MR (optional) within 1 month before randomization；
5. Organ and bone marrow function tests within 1 month before chemotherapy suggest no contraindications to chemotherapy；
6. Cardiac ultrasound EF value ≧55%；
7. Females of childbearing age, with a negative serum pregnancy test 14 days before randomization;
8. ECOG score≤1 point;
9. Sign informed consent；

Exclusion Criteria:

1. The patient has evidence of metastatic breast cancer；
2. For this disease, chemotherapy, endocrine therapy, targeted therapy, radiation therapy, etc. have been received;
3. The patient has a second primary malignancy other than adequately treated skin cancer;
4. The patient has been treated with anti-programmed cell death protein 1 (anti-PD-1), anti-programmed death ligand 1 (anti-PD-L1) or anti-PD-L2 drugs, or other immunotherapy；
5. The patient has been diagnosed with immunodeficiency disease or autoimmune disease;
6. The patient has severe lung or heart disease;
7. The patient has active hepatitis B and C;
8. The patient has a history of organ transplantation or bone marrow transplantation;
9. pregnant or breastfeeding women;
10. The investigators considered chemotherapy contraindicated due to serious, uncontrolled other medical conditions.
Pilates and PNF Methods Induces Similar Strength Gains

To compare the influence of a training program with Pilates and PNF methods to elderly women on the strength gains and motor control during voluntary contractions

Sixty healthy elderly women were randomly divided into 3 groups: Pilates group (PG), PNF group (PNFG) and Control group (CG). Pilates and PNF groups underwent one-month (three times per week) training program with Pilates and PNF methods, respectively. CG received no intervention along the one month. The maximal isometric force from knee extension and flexion, as well as the EMG signal from quadriceps and biceps femoris were recorded before and after the one-month intervention period. A two-way analysis of variance (3 groups x 2 measures) was used to compare the results from EMG signal, isometric force and force variability and force spectrum. A one-month training program with Pilates and PNF methods induces similar strength gains from knee flexors and extensors, without differences between methods, but PG exhibited greater low gamma drive (i.e., 30-60 Hz band) after the training period. Both Pilates and PNF methods were efficient to improve the muscle strength, but with different neuromuscular adaptations in elderly women. These results give support to the recommendation these methods to older age groups, since the increment of lower limb muscle strength is important for gait, postural stability and performance of daily life activities of this population.

Eligibility Criteria:
Inclusion Criteria:

* All the subjects were between 60 an 80 years old, sedentary and healthy

Exclusion Criteria:

* Subjects were excluded from the study if they presented any orthopedic, neurological, cardiac, vestibular, visual, or psychiatric impairment which would not allow them to perform all the tasks in the study
UNIPDES- An Internet-Based Transdiagnostic Intervention for College Students' Psychological Symptoms

This study is a randomised clinical trial. This study evaluates the effect of an internet-based intervention developed based on a transdiagnostic cognitive behavioural approach on psychological symptoms of university students. There are internet-based guided intervention, internet-based unguided intervention and control group in the study.

Experimental group participants (guided and unguided) will use the UNIPDES programme developed within the scope of the project. Participants in the guided internet-based experimental group will additionally receive weekly feedback from the guide .

This study is a randomised clinical trial. This study evaluates the effect of an internet-based intervention developed based on a transdiagnostic cognitive behavioural approach on psychological symptoms of university students. There are internet-based guided intervention, internet-based unguided intervention and control group in the study.

Experimental group participants (guided and unguided) will use the UNIPDES programme developed within the scope of the project. Participants in the guided internet-based experimental group will additionally receive weekly feedback from the guide .

There is a six-week intervention protocol within the programme. This intervention programme includes structured, emotional, cognitive and behavioural interventions independent of the diagnosis.

Users will complete each module in 30-40 minutes. The programme is structured in a hierarchical order. Each session is a preliminary to the session that follows it.

The data will be compared with suitable statistical techniques.

Eligibility Criteria:
Inclusion Criteria:

* volunteering to participate in the study;
* having a valid e-mail address;
* having internet access (computer or mobile device);
* being over the age of 18;

Exclusion Criteria

* ongoing psychological support/psychotherapy during the research period;
* scoring more than 15 on the Patient Health Questionnaire 9 (PHQ 9) and more than 14 on the Generalized Anxiety Disorder-7 (GAD-7) scales
A Study to Assess the Safety and Preliminary Efficacy of PT-523 in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

This phase I/II, multi-centered, non-randomized trial is designed to determine a safe dose of PT-523 for subjects, and to make preliminary evaluations on the activity of PT-523 as therapy in subjects with NSCLC.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Histologically or cytologically confirmed NSCLC which is stage III or stage IV, or recurrent disease, and failed therapy with a standard first line (Phase I/II) as well as second line chemotherapy regimen (Phase I), or be intolerant of standard chemotherapy. Receipt of one additional prior chemotherapy regimen for neoadjuvant, adjuvant, or neoadjuvant plus adjuvant is allowable. A prior epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TK) antagonist is allowable (Phase II).
* Asymptomatic or treated brain metastases (including steroids) if last therapy was received \> 4 weeks from study entry and is deemed by the investigator to have a low likelihood of rapid deterioration.
* ECOG performance status 0 - 2.
* Adequate organ function and bone marrow reserve.
* Use of appropriate contraceptive method.
* Signed patient informed consent.

Exclusion Criteria:

* Investigational agents within 30 days prior to Day 1 of study.
* Known symptomatic or uncontrolled brain metastases.
* Uncontrolled intercurrent illness.
* Known human immunodeficiency virus (HIV), hepatitis A, B, C, D and E.
* Patient has uncontrolled pleural effusions.
* Patient has received nitrosoureas or mitomycin-C within 6 weeks or other chemotherapy or radiation therapy within 3 weeks before study entry.
Prevention of Phantom Limb and Stump Pain Using Ambulatory Continuous Peripheral Nerve Blocks: A Pilot Study

The purpose of this research study is to determine if putting local anesthetic through one or two percutaneous catheters placed next to the nerves that go to an amputated limb will decrease long-term pain in the amputated limb.

Specific Aim 1: To determine if, compared with current and customary analgesia, the addition of multiple-day ambulatory continuous peripheral nerve blocks decrease the incidence and severity of post-amputation phantom limb and stump pain.

Hypothesis 1: Following upper or lower extremity amputation, the incidence of phantom limb and/or stump pain will be significantly decreased four weeks following multiple-day ambulatory continuous peripheral nerve blocks as compared with patients receiving standard-of-care treatment.

Hypothesis 2: Following upper or lower extremity amputation, the severity of phantom limb and/or stump pain will be significantly decreased four weeks following multiple-day ambulatory continuous peripheral nerve blocks as compared with patients receiving standard-of-care treatment (as measured on the 11-point numeric rating scale).

Eligibility Criteria:
Inclusion Criteria:

* undergoing unilateral surgical amputation of the upper or lower extremity including at least one metacarpal or metatarsal bone, respectively
* currently without phantom limb and/or stump pain in a previously-amputated limb
* ages 18 years or older
* desiring perineural infusion for up to 6 days
* willing to have an ambulatory infusion following hospital discharge

Exclusion Criteria:

* hepatic or renal failure
* allergy to the study medications
* pregnancy
* incarceration
* possessing a contraindication to perineural catheter placement or perineural local anesthetic infusion
Improving Access to Chiropractic Care in Community Health Centers

The goal of this study is to evaluate the feasibility of new implementation strategies designed to increase the number of Primary Care Providers (PCPs) referrals to chiropractic care for lower back pain (LBP) in underserved populations. The investigators plan to pilot the strategies in three qualified community health centers (CHCs) and compare the number of LBP patients who receive referrals before and after implementation. The implementation strategies involve PCP, patient, and organizational interventions.

Patients presenting with LBP will be provided educational materials that focus on the safety and effectiveness of chiropractic care as an evidence-based treatment for LBP. Materials will be available in CHC common areas and may be sent to patients by their PCP via patient portal.

PCPs will participate in interactive lunch seminars to allow for inter-professional learning for PCPs. They will also participate in a survey regarding their attitudes and beliefs relating to chiropractic care. Currently, many PCPs cannot make chiropractic care referrals in the electronic health record (EHR). The investigators plan to add this option, or make it easier if the referral is already available.

This multi-level, multi-component approach will last two months, and will be rolled out sequentially in three clinics using a stepped-wedge design. The ordering of clinics will be random.

The primary outcome is the proportion of patients with LBP who received a referral to chiropractic care before and after the intervention. Secondary outcomes include referral to any non-pharmacologic treatment, use of imaging, and prescribed medications.


Eligibility Criteria:
Inclusion criteria for CHCs:

* Be a CHC in the Boston area with primary care
* Agree to participate in study

Inclusion criteria for PCPs:

* Work at a participating CHC
* Be an MD, doctor of osteopathy (DO), nurse practitioner (NP), or physician assistant (PA)

Inclusion criteria for patients with LBP:

* Has PCP at participating CHC
* Has LBP diagnosis
* Is 18 years of age or older

Exclusion criteria for CHCs:

* There are no exclusion criteria

Exclusion criteria for PCPs:

* There are no exclusion criteria

Exclusion criteria for patients with LBP:

* There are no exclusion criteria for adult patients with LBP
Aerobic Exercise for Remyelination in Multiple Sclerosis

This is a clinical trial to determine the feasibility of a stationary aerobic cycling intervention and explore if aerobic exercise independently promotes remyelination in people with multiple sclerosis (MS).

Multiple sclerosis (MS) is the most common non-traumatic disabling neurologic condition of young adulthood, affecting more than 2.5 million people worldwide. Permanent disability in MS is caused by recurrent demyelination due to episodic inflammation, followed by neuronal damage, axonal degeneration, and progressive failure of remyelination. There is an urgent need to restore activity and participation in people with MS (pwMS), and remyelination is the most promising therapeutic strategy to accomplish this goal.

Remyelination in pwMS will likely require integration of pharmacologic and rehabilitative approaches to ensure effective remyelination of appropriate neural pathways. Aerobic exercise is an ideal complement to remyelinating medications because aerobic exercise 1) improves walking function in pwMS, and 2) promotes remyelination in animal models both independently and synergistically with medications. However, there are many unknowns that need to be addressed before aerobic exercise can be explored in multimodal clinical trials for remyelination. First, it is imperative to understand how myelination impacts disability in MS, as many other factors could contribute to reduced activity and participation. Additionally, as remyelination occurs over 12 to 24 weeks, it is imperative to establish the feasibility of similar duration of aerobic exercise interventions, and explore if exercise independently influences established remyelination outcomes before integration into multimodal strategies.

This is a randomized, single-blind, parallel clinical trial of a 24-week aerobic stationary cycling intervention to determine feasibility and explore if aerobic exercise independently promotes remyelination in pwMS.

Eligibility Criteria:
Inclusion Criteria:

* Physician-confirmed diagnosis of MS based on the 2017 McDonald criteria
* 18-64 years old
* Have access to the internet and a device that can access virtual visits
* (Inclusion criteria to advance to clinical trial) Somatosensory evoked potential (SSEP) latency z-score ≥2 for P40 or inter-side difference in z-score ≥2 for P40

Exclusion Criteria:

* Medical or biophysical conditions that prohibit the use of a cycle ergometer or treadmill (medical readiness to be assessed by the Activity Readiness Questionnaire (PAR-Q)) or achievement of target heart rate.
* Engages in \>30 minutes/week of aerobic activity regularly.
* Clinically confirmed MS relapse in the last 3 months.
* Changes in disease modifying therapy (DMT) for MS in the last 6 months.
* Pregnant women.
* Treatment with steroids for MS in the last 30 days.
* Concurrent use of 4-aminopyridine or dalfampridine (medications which can alter SSEP) and unwilling to discontinue it for 2 days prior to SSEP testing.
* Have a known history of severe spinal canal stenosis