cyrilzakka/clinical-trials huggingface dataset:
A Study of Lasmiditan on the Heart in Healthy Participants

The purpose of this study was to determine how two doses of lasmiditan affected the heart in healthy participants. The study also evaluated how much lasmiditan got into the blood stream and how long it took the body to get rid of it. Information about side effects was collected. The study lasted a maximum of 46 days for each participant, not including screening.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index within 18.5 and 29.9 kilograms per meter squared (kg/m²)
* In good physical and mental health as determined by the following:

  * Complete medical history
  * Complete physical examination
  * Vital signs including blood pressure (supine and standing), heart rate (supine and standing), respiratory rate, and temperature
  * Standard 12-lead ECG (triplicate ECG), followed by a 24-hour Holter ECG for arrhythmia monitoring
  * Clinical laboratory tests

Exclusion Criteria:

* Any of the following cardiac abnormalities on safety screening ECG:

  * QTcF interval \>430 milliseconds (ms) for males, \>450 ms for females
  * Unusual T wave morphology or flattened low voltage T waves
  * PR interval \>240 ms or \<110 ms
  * Second-degree or third-degree atrioventricular block
  * ECG evidence of complete left or right bundle branch block
  * Intraventricular conduction delay or QRS duration \>110 ms
  * Supine resting heart rate \<45 beats per minute (bpm) or \>90 bpm
  * Pathological Q-waves
  * Evidence of ventricular pre-excitation
* Participants with a history of syncope, cardiac arrest, cardiac arrhythmia or torsade de pointes, or structural heart disease
* Participants with a family history of Long QT syndrome
* History of allergic hypersensitivity to lasmiditan or any component of the formulations
* History or current evidence of abuse of any drug substance, licit or illicit, including alcohol; a positive urine screen for drugs of abuse
* Participants with a history of postural hypotension or fainting
* Participant is not able to understand and comply with study requirements, instructions and study restrictions
Post-reimbursement Study to Follow Spinal Neurostimulator Devices for Pain Therapy (French SCS Registry)

Observational study to evaluate the long term efficacy of Spinal Cord Stimulation (SCS) over 2 years following SCS implant.

This study is requested by French Health Authorities for reimbursement renewal, to maintain reimbursement for SCS in approved indication in France.


Eligibility Criteria:
Inclusion Criteria:

* Patient indicated for Spinal Cord Stimulation (pain therapy)
* Patient implanted for less than 3 months or hospitalized for the implant of a Medtronic neurostimulator including:
* primary implant with Spinal Cord Stimulation indication and positive test of stimulation or
* device replacement of a Medtronic neurostimulator used for Pain Therapy
* Evaluation of usual pain in the back, upper and lower limbs using a visual analogic scale must be available for the 3 days preceding implant.
* Treatments must also be available
* Patient read and signed the data release form

Exclusion Criteria:

* Patient declined participation
* Patient is not available for follow up
* Stimulation of other body part than spinal
Leg Exercise During ECMO

Patients undergoing extracorporeal membrane oxygenation (ECMO) are at high risk for deconditioning and functional decline. The primary aim of this study is to assess the functional impact of leg exercise during the pre-ambulation phase in patients undergoing ECMO.

The investigators are conducting this study to explore the impact of closed-chain leg exercise in individuals undergoing ECMO.

Aim 1: To determine if closed-chain leg exercise decreases the time to initial ambulation. The investgators hypothesize that adding leg exercise will decrease time to ambulation.

Aim 2: To determine the impact of closed chain leg exercise on functional ability. The investigators hypothesize that adding leg exercise will improve functional outcomes when added to an existing early mobilization program.

Aim 3: To determine the effect of closed chain leg exercise on hospital outcomes. The investigators hypothesize that hospital related outcomes will improve when leg exercise is added to an existing early mobilization program.

Eligibility Criteria:
Inclusion Criteria:

* Patients with refractory respiratory failure undergoing ECMO at the University of Minnesota Medical Center, Fairview.
* Able to follow 3 out of 3 one-step commands via protocol.
* Active Inpatient Physical Therapy Referral.
* ECMO delivery is veno-venous with internal jugular catheter.

Exclusion Criteria:

* Femoral catheter of any kind present
* Veno-arterial ECMO set-up
* Sedation such that self-consent is not attainable
* Medical instability, as determined by primary critical care physician
Treating Adolescents With CBT and OBH

The purpose of this study is to examine various behavioral, social, and emotional changes that result from engaging in an OBH and CBT treatment program designed for adolescents.

After being informed about the study and potential risks, all study participants, including minors and parent/guardians, giving written informed consent will complete a screening survey. The screening survey will support research staff in determining whether participants meet the inclusionary and exclusionary data, including meeting scores on the Youth Outcome Questionnaire and the Revised Children's Anxiety and Depression Scale. If participants are eligible based on preliminary criteria, they undergo a screening interview. If participants are eligible following the screening interview and complete a second informed consent, minors and parents/guardians, they will be randomized in a partially-blind, parallel-group study conducted in the United States (7 Outdoor Behavioral Healthcare programs and up to 42 CBT-licensed therapists).

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 13 and 17 years of age
* 5th grade reading level
* For minors, informed assent
* Parental informed consent and adult consent to participate in the study
* Current diagnosis of Depression and/or Anxiety per parent report, parental interview, and score of 65 on the RCADS. Youth with comorbid diagnoses of these listed diagnoses are eligible
* Current secondary diagnosis of Substance Use Disorder (optional)
* Score greater than a 47 on the YoQ-2.0
* Willingness to participate in all aspects of the treatment programs
* Has the ability to carry a pack that is 1⁄4 their body weight

Exclusion Criteria:

* Primary Diagnosis of Substance Use Disorder
* Antisocial Personality
* Level 2 or higher Autism Spectrum
* Schizophrenia
* Actively suicidal
* Eating disorders
* BMI greater than 34
* Diabetic
* Physical ailments or disabilities limiting person from hiking, camping, backpacking
* Specific medications including Anxiolytics/Benzodiazepines, Opiates, or multiple Antipsychotics and Mood Stabilizers
* Youth who have a positive pregnancy test
* Participation in another treatment or intervention study within one year of beginning the study
* Individuals currently suffering from detoxification as a result of drug use in the last five days. If drug use occurs during this time period, the participant must wait until they have achieved five days of substance free behavior. This is done to prevent contraindications of treatment (e.g., interaction between drugs and the environment)
* Currently practicing violent behaviors to self or others within the past year per Parent Report
* Currently experiencing hallucinations (hearing voices or seeing things that are not there)
The Probiotic Study: Using Bacteria to Calm Your Mind

The investigators seek to conduct the first open-label trial of probiotics in young children to reduce their anxiety and abdominal pain. Likewise, the investigators aim to assess the feasibility and efficacy of this treatment and to elucidate the enteric microbiota in the middle-lower GI tract. Self-report measures and a laboratory task will be collected from children, ages 9-13 years of age, and self-report measures from their primary caregivers prior to and following a 30-day probiotic administration. Children who score above cutoff in anxiety and/or abdominal pain meet the inclusion criteria for this study. Because of limited sample size and the iterative nature of intervention development, criteria for success at the pilot phase are based primarily on clinical rather than statistical criteria. The study personnel will do their best to keep and ensure the privacy and confidentiality of our participants; however, some of the risks of this study may include psychological discomfort, legal risks, and loss of confidentially.


Eligibility Criteria:
Inclusion Criteria:

Participants need to meet the criteria for functional abdominal pain as specified by the Rome III:

Scenario #1 Criteria for inclusion

1. In the last 2 months, how often did the child have pain or an uncomfortable feeling in the upper abdomen above the belly button? If ≥ 8 (or if the combination of #1 and #2 is ≥8)
2. In the last 2 months, how often did the child have pain or an uncomfortable feeling in the upper abdomen below the belly button? If ≥ 8 (or if the combination of #1 and #2 is ≥8)

Scenario #2 Criteria for inclusion 3. In the last 2 months, when the child hurt or felt uncomfortable above (below) the belly button, how often did your child miss school or stop activities? If #1 and #2 is ≥ 2 (or if the combination of #1 and #2 is ≥2) and #3 is ≥ 25% of the time.

They also have to be at or above cutoff (i.e. TS\>= 55) for Beck Youth Inventory (BYI) which can be determined by finding the corresponding raw score, gender, and age on Appendix A in the BYI manual.

Exclusion Criteria:

1. Participants with immune disorders will be automatically excluded from this study.
Natural History Study in Patients With LGMDR5/2c

Prospective, longitudinal, interventional, multicenter natural history study to better understand the LGMDR5/2c disease physiopathology. The duration of participation for each patient will be up to 24 months.

Study duration Duration from First visit of first patient (FPFV) to Last visit of last patient (LPLV) : 3 years. Each patient will have a visit every 6 months over 2 years (5 visits in total).

Study primary objective is to characterize the disease course in gamma-sarcoglycanopathy (LGMDr5/2c) patients using standardized and disease appropriate evaluations.

Secondary objectives are to identify clinical, imaging and/or laboratory parameters that are indicators of the disease course in LGMD2c and to identify the best outcome measure for further therapeutics approaches

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients 6 to less than 35 years of age
* Ambulant patients should be less than 12 years of age and able to walk/run 10 meters (item 29 of NSAD) in less than 15 sec
* Confirmed diagnosis of LGMDR5 (genotyping)
* FVC \> 40%

Exclusion Criteria:

* Subjects with co-morbidity which may interfere with LGMDR5 natural evolution and/or evaluation of outcome measures
* Need of non-invasive ventilation \> 16h per 24h or any invasive ventilation
* Left ventricular ejection fraction (LVEF) \< 30% or prior heart failure decompensation requiring hospitalization
* Past participation in a gene therapy or cell therapy trial
Telehealth-Enabled Versus In-Person Parent-Mediated Behavioral Treatment for Challenging Behaviors in Children With ASD

The purpose of the research is to determine whether parent-mediated behavior therapy for challenging behavior commonly displayed by children with autism spectrum disorder (ASD) can be as effective when delivered via telehealth as when delivered in-person.


Eligibility Criteria:
Inclusion criteria:

1. Child is aged 2 years 0 months to 7 years 11 months inclusive
2. Child has a documented diagnosis of ASD
3. Child exhibits at least one form of daily or hourly self-injurious behavior and/or aggressive behavior on the Behavior Problems Inventory - Short Form (BPI-S)71,72
4. Family lives in one of the following counties in New Mexico and Texas: Bernalillo, Santa Fe, Valencia, Sandoval, Torrance, Socorro, Cibola, Los Alamos, El Paso, Hudspeth, Otero, McKinley, San Miguel, Eddy, Chaves, or Dona Ana.
5. Caregiver is comfortable speaking and reading in English
6. The child's caregiver is at least 21 years old
7. The same caregiver is consistently available for one hour per week for a 12-week period in their home with their child between 9am and 7pm Monday through Friday to take part in the research
8. Caregiver is willing to adhere to the study intervention regimen and be willing to have a clinician come into their home for 1 hour per week for 12 weeks
9. Family lives in an area with consistent cell phone coverage

Exclusion criteria:

1. Caregiver is currently receiving ABA services or direct parent coaching to manage their child's challenging behaviors
2. Child engages in behavior that may inflict moderate to severe damage on the individual or on other people (e.g. biting through the skin, eye gouging, fracturing bones, significant damage to property) with minor or major medical intervention required.
3. Child has a sensory or physical impairment that precludes participation (e.g., epilepsy, vision or hearing impairment) or has a diagnosis of another genetic condition (e.g., fragile X syndrome)
4. Activity restrictions that limit caregiver's ability to respond to their child's challenging behaviors
5. Child has an underlying medical condition that is better treated with medical intervention
6. Child only exhibits pica at a daily or hourly frequency on the BPI-S
7. The caregiver has another child already participating in the study
Protecting Health Care Workers During the COVID-19 Outbreak

Preparing to deal with Covid-19 outbreak in Rajasthan, India, health care workers were given Ayurvedic Kadha (combination of ayurvedic herbal extracts) starting from the end of February 2020. Then, majority of these health care workers were put on front line managing screening, monitoring, quarantine and treating Covid 19 patients. This real-life study aimed to determine the experience of health care workers who had Ayurveda kadha before starting as front-line workers.


Eligibility Criteria:
Inclusion Criteria:

* Health care workers posted in Covid-19 duties at front line
* Health workers who had Ayurveda herbs combination over for at least 10-days

Exclusion Criteria:

* No willing to consent
* inability to participate
A Clinical Trial Comparing Efficacy and Safety of Exubera® and Humalog®

To compare efficacy and safety of Exubera® vs Humalog in patients with type 1 diabetes mellitus

Pfizer announced in October 2007 that it would stop marketing Exubera®. At that time recruitment for study, A2171035 was placed on hold. Nektar, the company from which Pfizer licensed Exubera®, announced on April 9, 2008 that it had stopped its search for a new marketing partner. Accordingly, there will be no commercial availability of Exubera®. As a result, study A2171035 was terminated on May 12, 2008. Neither safety nor efficacy reasons were the cause of the study termination.

Eligibility Criteria:
Inclusion Criteria:

* Diabetes mellitus Type 1

Exclusion Criteria:

* Severe Asthma, severe Chronic Obstructive Pulmonary Disease (COPD)
* Smoking
Optimization of Patients Long-term Management After the Coronavirus Infection COVID-19

200 participants should be included in the study. There will be three groups: 100 participants with a severe course of the disease 3 months ago, 50 asymptomatic carriers of coronavirus infection 3 months ago and 50 people who were in close contact with patients with confirmed coronavirus infection 3 months ago, but not sick and without antibodies to SARS-CoV-2.

The study consists of two visits. At the first visit, after signing the consent to participate in the study, a screening examination will be performed to assess the criteria for inclusion and exclusion in the study.

At the second visit, patients who meet the inclusion criteria and do not have exclusion criteria will undergo clinical and instrumental examination, and biological samples will be collected for laboratory testing.

The aim of the study is to determine the most significant clinical and laboratory markers of the severity of the outcomes in the period of convalescence of the new coronavirus infection COVID-19. Clinical and laboratory indicators, the number and severity of signs of postcovid syndrome as well as pathological changes in lung tissue according to CT data in the group with covid pneumonia and indicators of immune status, hemostasis, endothelial dysfunction, inflammation, metabolism will be assessed.


Eligibility Criteria:
Inclusion Criteria:

For all groups:

* Informed consent signed by the patient.
* Men and women aged 18 and over.

Group COVID-19 (asymptomatic):

* Confirmed diagnosis of COVID-19 (positive SARS-CoV-2 RNA PCR test or history of IgM and / or IgG antibodies to SARS-CoV-2)
* Absence of any clinical symptoms associated with coronavirus infection.

Group Healthy:

* Contact with patients with symptomatic new coronavirus infection COVID-19 in the absence of personal protective equipment for at least 3 days.
* Absence of any clinical symptoms associated with coronavirus infection

Group COVID symptomatic:

* Confirmed diagnosis of previous COVID-19 (positive SARS-CoV-2 RNA PCR test or presence of IgM antibodies to SARS-CoV-2) in history.
* A severe course of COVID-19, characterized by one or more of the following symptoms:

  * Respiratory rate ≥ 30 in 1 min
  * Blood oxygen saturation (SpO2) ≤ 93%
  * The ratio of the partial tension of oxygen in arterial blood to the fraction of oxygen during inspiration (PaO2 / FiO2) \<300
  * Lung tissue lesion\> 50% and / or according to computed tomography CT-2 and higher
  * Septic shock / sepsis
  * Development of multiple organ failure
  * Cytokine storm

Exclusion Criteria:

* Pregnancy
* Covid-19 vaccination
* Any serious medical illness before coronavirus infection, as well as a permanent form of atrial fibrillation
* Regular intake of anti-inflammatory, antibacterial, cytostatic and immunosuppressive drugs
* Refusal to participate in the study
Diagnostic Study to Predict the Risk of Developing Metastatic Cancer in Patients With Stage I or Stage II Melanoma

RATIONALE: Diagnostic procedures that analyze surgically-removed tumor tissue and lymph node samples may help doctors identify patients with melanoma who are at risk for developing metastatic cancer.

PURPOSE: This clinical trial is studying tumor tissue and lymph node samples to see how well they work in predicting the development of metastatic cancer in patients with stage I or stage II melanoma.

OBJECTIVES:

* Correlate degree of melastatin gene expression with risk of developing local regional metastases in patients with primary stage I or II melanoma.
* Correlate melastatin expression prospectively with event-free survival of these patients.

OUTLINE: This is a multicenter study.

Melastatin mRNA expression is determined by in situ hybridization using tissue from primary tumor and lymph nodes. Tissue is also examined by immunohistochemical staining using antibodies to S-100 and MART-1. Patients do not receive the results of these tests nor do the results influence individual therapy.

Patients are followed every 4 months for 3.5 years.

PROJECTED ACCRUAL: A total of 300 patients will be accrued for this study within 3.5 years.

Eligibility Criteria:
1. Histologically documented primary AJCC stage I or II melanoma. Evidence of ulceration, vertical growth phase, regression, lymphocytic infiltration, vascular invasion, microscopic satellitosis, and mitotic rate shall be noted.
2. Patients planning to undergo a sentinel lymph node biopsy, or an elective lymph node dissection of an anatomic draining region from the index primary melanoma.
3. ≥18 years of age
4. Patients must be registered prior to planned surgery. The surgery must be performed within 45 days following registration.
5. No concurrent active malignancy other than carcinoma in situ of the cervix and basal cell carcinoma of the skin, or history of any other primary malignancy including previously primary melanoma.
6. Tissue blocks: one of primary tumor tissue taken from region of greatest Breslow thickness. Note: If blocks cannot be sent due to institutional policy, slides may be substituted for the locks per the protocol.
Assess the Utility of a Speech-based Machine Learning Algorithm to Predict Treatment Response to Psychiatric Interventions

This is a research study looking at whether the way people speak can help predict how well they'll respond to certain mental health treatments.

The Main Goal:

The researchers want to see if computer analysis of a person's speech patterns can predict whether they'll respond well to two specific treatments: TMS (Transcranial Magnetic Stimulation) and Spravato (a nasal spray medication). They're focusing on people with depression, bipolar disorder, OCD, anxiety, and PTSD.

How It Works:

200 people with these conditions will participate in the study.Participants will record themselves speaking for about 12 minutes, responding to six different prompts.They'll do these recordings before treatment starts, daily during treatment, right after treatment ends, and again four weeks later. Doctors will track how well people are doing using various questionnaires and rating scales The researchers will look for connections between speech patterns and treatment success. The study will last 12 months.

What Makes Someone a "Treatment Success":

The study considers treatment successful if a person's symptoms improve significantly (specifically, a 2-point or greater reduction on a clinical rating scale (called Clinical Global Impression) and stays improved during the follow-up period (4-weeks).

Why This Matters:

If successful, this research could lead to a simple, non-invasive way to help doctors predict which treatments might work best for different patients. This could help people get the most effective treatment more quickly and help healthcare providers use their resources more efficiently.

Safety Consideration The researchers will also check whether doing the speech assessments causes any distress to participants, making sure the evaluation process itself is safe and comfortable.


Eligibility Criteria:
Inclusion Criteria:

1. Outpatient status
2. Men and women aged 18-68 years
3. Capable and willing to provide informed consent
4. Able to adhere to the treatment schedule
5. Stable on medication for at least 2 months with no anticipated changes during the study period
6. Diagnosis of MDD, PTSD, or BD
7. Eligible for and scheduled to receive TMS or Spravato (esketamine) treatment to alleviate symptoms of MDD, PTSD, GAD, OCD or BD
8. Fluent in English
9. Access to a stable internet connection and an electronic device with a microphone for voice recording

Exclusion Criteria:

1. Use of any investigational drug within four weeks of the baseline visit
2. If participating in psychotherapy, the patient must have been in stable treatment for at least three months before study entry, with no anticipated changes in the frequency of therapeutic sessions or therapeutic focus during the TMS or Spravato treatment.
3. Intoxication during speech assessments
4. Cognitive impairment that would interfere with study participation or data quality
5. Lack of fluency in English