cyrilzakka/clinical-trials huggingface dataset:
Repeated Dose IV Baclofen Safety/Bioequivalence Study

The purpose of this study is to identify a suitable dosing regimen of IV baclofen to serve as a temporary substitute for an oral regimen.

Baclofen intravenous solution 2 mg/mL will be manufactured and provided by Allaysis, LLC. Prism Clinical Research will purchase oral baclofen tablets (10 mg) from a commercial supplier. Subject will start baclofen at a 5 mg oral dose every 8 hours. Oral baclofen will be increased incrementally and self-administered over 13 days to a maximum dose of 20 mg every 8 hours. Subjects will be crossed over to 16 mg intravenous baclofen infused over 120 (n=6) or 150 (n=6) minutes every 8 hours for 11 doses. Subjects will be changed back to oral baclofen at a 15 mg dose self-administered every 8 hours and tapered off of baclofen over 15 days. Following the completion of this group of 12 subjects, the remaining 30 subjects will receive IV baclofen at the infusion duration that best meets the criteria for bioequivalence.

Eligibility Criteria:
Inclusion Criteria:

* Males and females between the ages of 18-45. An attempt will be made to recruit an equal number of men and women into each dosing group; however a ratio of 2:4 in the initial run-in phase and 12:18, with either women or men in the majority is acceptable.
* Subjects are capable of giving informed consent.
* Females capable of bearing children should practice at least one or more of the following methods of contraception for at least one month prior to the and during the study: hormonal, intrauterine device (IUD), or barrier method in combination with a spermicide. Female subjects who are postmenopausal (no menses for greater than one year) or surgically incapable of bearing children may participate.
* Subject should be medication free, other than hormonal birth control, for 48 hours before through 24 hours after completion of study drug administration. If the need for medication is identified during this time period, it will be discussed with and approved by the PI.

Exclusion Criteria:

* Women who are pregnant.
* Women who are breastfeeding.
* Subject has a history of intolerance to IV administration of medication.
* Subject has a known hypersensitivity to baclofen.
* Subject has a significant history of cardiac, neurologic, psychiatric, oncologic, endocrine, metabolic, renal or hepatic disease
* Subject has taken or used any investigational drug or device in the 30 days prior to screening.
* Subject has taken either prescribed or over the counter medication, other than hormonal birth control within 48 hours prior to baclofen administration, unless approved by the Principal Investigator.
* Subject reveals clinically significant abnormalities on screening laboratory tests.
* Subject is a non-English speaker, such that ability to ascertain neurological status would require an interpreter.
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of APL180

The design of this study will enable an extensive evaluation of safety, tolerability, and PK-PD relationship following 4 weeks of dosing in patients with Coronary heart Disease


Eligibility Criteria:
Inclusion Criteria:

* Male and female CHD or CHD equivalent patients
* Body mass index (BMI) must be within the range of 20 to 35 kg/m2,
* Patient must have been on a stable statin therapy for \>8 weeks prior to first dose except for the statin intolerant patients.

Exclusion criteria:

* Pregnancy
* Significant illness within two weeks prior to dosing.
* Triglycerides ≥ 500 mg/dl (5.65 mmol/l)
* Uncontrolled hypertension
* Any condition that in the opinion of the investigator or the Novartis medical monitor would jeopardize the evaluation of efficacy or safety.
* Presence of NYHA Class III or IV chronic heart failure
* MI or angioplasty (including stenting), acute coronary syndrome (ACS), unstable angina or arterial embolic disease within 6 months prior to do Other protocol-defined inclusion/exclusion criteria may apply
The Effect of Melatonin on Gene Expression and Activity of the Sirt1 and Its Target Genes Catalase and MnSOD in Multiple Sclerosis Patients and Healthy Subjects

The purpose of this study is to investigate the gene expression and activity of SIRT1, and forkhead box O3 pathway by means of investigating target genes MnSOD and catalase in multiple sclerosis and healthy subjects. Also, we investigate the effect of melatonin on interaction between SIRT1 activity and target genes MnSOD and catalase in multiple sclerosis and healthy subject .Additionally, we evaluate effect the probable effect of melatonin treatment on gene expression and activity of above-mentioned genes in peripheral blood mononuclear cells of healthy subjects-treated with H2O2.


Eligibility Criteria:
Inclusion Criteria:

patients with relapsing-remitting multiple sclerosis. The diagnosis of MS was based on the McDonald criteria . All patients were newly diagnosed cases with an Expanded Disability Status Scale (EDSS) score ≤ 6 and had never received immunomodulatory and immunosuppressive drugs.

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Exclusion Criteria:

* The exclusion criteria were as follows: 1) treated with antioxidant supplements, anti-inflammatory drugs, and vitamins in the previous 6 months; 2) had a history of acute or chronic infection, malignancy, diabetes (type I and II), and any clinically significant systemic disease; 3) was currently pregnant or lactating; 4) was currently smoking; 5) used contraceptive medication during the previous 6 months.
Effectiveness of a Developmental Reciprocity Treatment Program in Autism

This is a research study examining the effectiveness of a Developmental Reciprocity Treatment Program (DRT-P) in treating social deficits in children with Autism Spectrum Disorders (ASD). Developmental Reciprocity Treatment is an early intervention that applies developmentally-informed teaching methods in naturalistic settings in order to target social and communication deficits.

Researchers have begun to develop strategies to investigate the effectiveness of combining a parent training program teaching parents how to implement DRP with in-home, therapist-implemented treatment. To determine the effectiveness of the DRT-P, it will be compared to a delayed treatment group (DTG) by conducting a randomized controlled 24-week trial. This research will allow us to help in the development of therapeutic approaches that can meet the increasing service demands for families. We hope that investigating interventions that aim to improve core deficits will aid in providing better care for children with autism.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Autism Spectrum Disorder based on Autism Diagnostic Interview Revised (ADI-R), Autism Diagnostic Observation Schedule (ADOS-2), DSM-5, and expert clinical opinion;
* Males and females in good medical health between 2.0 and 5 years 11 months;
* Ability to participate in the testing procedures to the extent that valid standard scores can be obtained;
* Stable treatment (e.g., applied behavior analysis), speech therapy, psychotropic medication(s) or biomedical intervention(s) for at least 1 month prior to baseline measurements with no anticipated changes during study participation;
* Availability of at least one English-speaking parent who can consistently participate in parent training and research measures;
* Clinical Global Impression(CGI) Severity Social Interaction and Communication Integrated Subscale ≥4;
* Meet the cutoff for Autism on the ADOS-2.

Exclusion Criteria:

* Current or lifetime diagnosis of severe psychiatric disorder (e.g., bipolar disorder, etc.);
* A well-established genetic syndrome, such as Fragile X;
* Presence of active medical problem (e.g., unstable seizure disorder or heart disease);
* Child's primary language other than English;
* Previous adequate trial or training of a developmentally based intervention;
* Participants living more than 45 miles from Stanford University;
* Children with more than 20 hours of in-home ABA;
* At least one room of the house must be available to be dedicated to treatment during session times;
* There must be no serious health and safety risks present in the home environment;
* The research team has the right to refuse to perform sessions in-home even if the criteria above are met.
Persona MC vs Attune Total Knee Replacement Study

This study aims to compare clinical and functional outcomes of a cohort of patients that have undergone a medial congruent TKR to a similar cohort of patients that have undergone a conventional TKR and a cohort of control participants. Our null hypothesis is that there will be no difference in the functional outcome (as assessed by gait analysis) between Attune and Persona MC TKR.

This cross sectional, post-operative comparator gait study aims to compare the functional and patient reported outcomes of patients that have undergone a MC TKR to an age, gender, BMI, pre-operative diagnosis with satisfactory clinical outcome at one year (OKS \> 34) matched cohort of patients undergone a modern generation TKR which utilises a gradually reducing radius of curvature on the femoral component with conventional polyethylene (Attune) to a TKR with gradually reducing radius of curvature on the femoral component but a medial congruent (MC) TKR design (Persona).

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 years and above\*
2. Have undergone primary total knee replacement for either:

   1. Osteoarthritis
   2. avascular necrosis of the femur or tibia
3. Report an Oxford Knee Score greater than 34, obtained from usual clinical practice. OKS above 34 represents (range 0-48, high representing good outcome) a good outcome post-surgery.
4. Independent of study participation, patients received either commercially available Zimmer Biomet Persona MC bearing or DePuy Synthes Attune knee implants implanted in accordance with product labelling
5. 1-5 years post TKR surgery
6. An adequate understanding of written and verbal information in English in order to provide informed consent and answer the study questionnaires\* \* Control participants will meet same inclusion criteria except no primary TKR and OKS will not be required

Exclusion Criteria:

1. History of infection in the replaced joint and/or other local/systemic infection that may affect the prosthetic joint
2. Skeletal immaturity
3. Neuropathic arthropathy
4. Osteoporosis/any loss of musculature or neuromuscular disease that compromises the affected limb
5. Severe instability secondary to the absence of collateral ligament integrity
6. Pregnancy - routine clinical practice ensures that all female patients are asked whether they are pregnant and can safely receive x-rays or surgery as per standard consent forms
7. Patient is a member of a protected population (e.g., prisoner, mentally incompetent, etc.)
8. Patient has previously received partial or total knee arthroplasty for the ipsilateral knee
9. Patients who are unable to give voluntary informed consent.
10. Patients who are unable to walk unaided (post-surgery).
11. BMI \> 40

    \*\* Control participants will meet the same exclusion criteria as TKR patients
12. Patients who suffer with cognitive impairment such as Parkinson's or Alzheimer's disease resulting in impaired mental capacity.
13. Patients who are unable to walk unaided.
14. Patients who suffer from dizzy spells or fainting episodes.
The Effect of Head Position on the Intubating Condition Using Fiberoptic Bronchoscopy

For better view of fiberoptic intubation, the posture of neck is compared between neck flexion and extension.


Eligibility Criteria:
Inclusion Criteria:

* ASA class 1 or 2
* scheduled for general anesthesia with endotracheal intubation
* decided to join this clinical study voluntarily

Exclusion Criteria:

* history of difficult intubation
* anticipated the difficult intubation: Total airway score \> 6, upper lip bite test grade III, with cervical spine disease, history of head or neck surgery
* risk of aspiration
Emergency Medical Services (EMS) Telehealth to Speed STEMI Reperfusion

The aim of this study is to evaluate the impact of a Telehealth program on the time from First Medical Contact (FMC) to Reperfusion in STEMI (ST-elevation myocardial infarction) patients, by supporting local paramedics in their care delivery.

STEMI (ST-elevation myocardial infarction) is the most severe type of heart attack and carries a 30-day mortality of nearly 8%. Reperfusion therapy is the mainstay of treatment for STEMI, either by percutaneous coronary intervention (PCI) or fibrinolytics. Delays in reperfusion are associated with negative health outcomes. Specifically, each 30-minute delay in reperfusion corresponds to a 7.5% decrease in 1-year survival. The current body of literature clearly shows that rural EMS agencies often have longer transport times, which makes the 90-minute first medical contact (FMC) to PCI time goal difficult to achieve. Approximately 16% of Americans live more than an hour from a PCI-capable facility, reinforcing the need for timely therapies in rural prehospital settings to decrease heart muscle damage (disability) and mortality. An analysis of a large national EMS database, which showed that FMC to PCI times were longer for patients treated by rural EMS agencies even after these times were adjusted for distance to destination hospital.8In addition, preliminary data for Cherokee Tribal EMS, serving the Eastern Band of Cherokee Indians on the Qualla Boundary and its surrounding communities, show that none of their patients who called 9-1-1 for a STEMI received reperfusion within the AHA time goal. The American College of Cardiology and AHA support prehospital fibrinolytics when timely PCI cannot be performed. STEMI telehealth programs have yet to be implemented and tested in the United States.

Eligibility Criteria:
Inclusion Criteria:

* All patients calling 9-1-1 in Wilkes County with possible STEMI as determined by the on scene paramedics will be included in the data.

Exclusion Criteria:

* As this is a Quality Surveillance study, subjects will not be excluded.
Study Comparing Two Stop Smoking Intervention Efficacies

The proposed study will compare the efficacy of two psychological stop smoking interventions.

The proposed study comprises a randomised controlled trial (n = 620) which will compare the efficacy of two psychological stop smoking interventions. Specifically, Allen Carr's Easyway smoking cessation programme comprising one 5/6 hour group session (plus one or two 3 hour booster sessions over the following 3 months for those who require them) and a 1-1 counselling service available via the NHS (comprising one 30 minute session and four weekly follow ups of 10-15 minutes) will be compared. The efficacy of both treatments will be followed up at 4, 12 and 26 weeks after treatment. The evaluation will be compliant with the Russell 6 Standard (which requires, amongst other things, a double blind, randomised design, chemical verification of quit outcomes, and the inclusion of all participants who received treatment in the final analysis). The findings will add to the evidence base around the use of the Allen Carr method, in particular by testing it in non-commercial settings.

Eligibility Criteria:
Inclusion Criteria:

Current smoker Aged over 18 Prepared to be assigned randomly to one of two treatment conditions (NHS standard provision or Allen Carr's Easyway) Intend to quit smoking cigarettes.

Exclusion Criteria:

Individuals who would prefer an NHS provided treatment Currently in another RCT or similar research project Have a mental health condition Are pregnant Have a respiratory disease (such as chronic obstructive pulmonary disease or emphysema).

Unable to reach the treatment locations (London South Bank Universities Southwark Campus or SW20) .
Transcranial Direct Current Stimulation as Home Treatment in Depression

In this one-armed study the feasibility and effectiveness of a home treatment with transcranial direct currect stimulation in depression will be investigated.

In this one-armed study at least 10 patients with depression will be included who will get treatment with transcranial direct currect stimulation at home. One visit in the hospital before and one visit after the treatment are necessary. The correct application of the device by the patients will be ensured by video counseling and monitoring. Treatment will last six weeks with 2 mA applied every working day for 20min with prefrontal montage.

Aim of the study is the evaluation of the feasibility of this home treatment (usability of the device, compliance of patients, usability of the video contacts), the effectiveness (clinical ratings) and the tolerability of this treatment.

Eligibility Criteria:
Inclusion Criteria:

* depressive episode according to ICD-10
* moderate depression according to clinical impression or Hamilton depression rating scale
* gender: all sexes
* age: 18-70 years
* stable medication if possible
* no or stable treatment of depression
* residence in Germany and mother language German
* written informed consent

Exclusion Criteria:

* contraindications for transcranial direct current stimulation
* neurological conditions
* participiation in another study
* pregnancy and lactation period
A Study of LY3866288 in Healthy Participants

The purpose of this study is to evaluate how well LY3866288 is tolerated and what side effects may occur in healthy participants. The study drug will be administered orally. Blood tests will be performed to check how much LY3866288 gets into the bloodstream and how long it takes the body to eliminate it.

The study will last up to approximately 9 weeks including screening.


Eligibility Criteria:
Inclusion Criteria:

* Females must be of nonchildbearing potential or of childbearing potential and agree to use contraception
* Males must either be infertile via bilateral orchiectomy or vasectomized at least 90 days prior to screening with proper documentation
* Body mass index (BMI) between 18.5 and 32.0 kilogram per square meter (kg/m²)
* In good general health, determined by no clinically significant findings from medical history, physical examination, 12 lead electrocardiogram (ECGs), vital signs measurements, or clinical laboratory evaluations at screening and/or check-in as assessed by the investigator (or designee)

Exclusion Criteria:

* Females only: Are lactating or pregnant
* Any history or presence of disease(s), deemed clinically significant:

  * Dermatological disease
  * Liver disease
  * Metabolic disease, including congenital nonhemolytic hyperbilirubinemia (e.g., Gilbert syndrome)
  * Gastrointestinal disease, including peptic ulcer disease, active malabsorption syndrome or other condition likely to affect gastrointestinal absorption of the study drug, or gastric reduction surgery. Note: participants with a history of appendectomy and/or inguinal hernia repairs will be acceptable
  * Biliary disease, including cholecystectomy
  * Cancer within the past 5 years (except localized basal cell, squamous, or in situ cancer of the skin)
  * History or current evidence of ophthalmic disorder, such as central serous retinopathy or retinal vein occlusion, active wet age-related macular degeneration, diabetic retinopathy with macular edema, uncontrolled glaucoma, corneal pathology such as keratitis, keratoconjunctivitis, keratopathy, corneal abrasion, inflammation or ulceration
  * Clinically significant, active cardiovascular disease or history of myocardial infarction within 6 months prior to first dose, or 12-lead ECG abnormalities that are clinically significant at screening
* History of alcohol and/or drug abuse within 2 years prior to screening
* Have been on a diet incompatible with the on-study diet, in the opinion of the investigator (or designee), and as confirmed by the sponsor, within the 30 days prior to Day 1 and throughout
* Use of tobacco, smoking cessation products, products containing nicotine, or e-cigarettes (nicotine and non-nicotine) within 90 days prior to screening and throughout
Evaluation of Marketing Interventions in Colombia

The proposed project seeks to implement a cluster-randomized controlled trial (RCT) to measure the impact of increasing women´s incomes and providing gender equality trainings on women´s empowerment and risk of intimate partner violence (IPV) in Colombia. This project will be the first in Latin America to evaluate rigorously the impact of a marketing intervention, alone and combined with IPV prevention training. The knowledge generated from this evaluation has the potential to identify the most effective solutions to empower women, as well as to drive transformative change in current approaches to reduce IPV and promote gender equality in highly vulnerable populations in Colombia, and worldwide.

The proposed project seeks to implement a cluster-randomized controlled trial (RCT) to measure the impact of increasing women´s incomes and providing gender equality trainings on women´s empowerment and risk of intimate partner violence (IPV) in Colombia. This project will be the first in Latin America to evaluate rigorously the impact of a marketing intervention, alone and combined with IPV prevention training. The knowledge generated from this evaluation has the potential to identify the most effective solutions to empower women, as well as to drive transformative change in current approaches to reduce IPV and promote gender equality in highly vulnerable populations in Colombia, and worldwide.

The goal of the project is to estimate the impact of generating livelihood opportunities and providing gender-based violence (GBV) training to reduce IPV among women in Colombia. This will generate much needed evidence on the most effective approach to empower women smallholder farmers and reduce their exposure to IPV. Investigators will conduct a cluster randomized controlled trial targeting approximately 100 smallholder farmers' associations and approximately 2700 women. Results will inform and strengthen future programming of humanitarian assistance and can be replicated in humanitarian interventions in other parts of the world.

The experimental operational research will compare two programmatic modalities and their impact on women's risk of exposure to IPV, against a comparison group where no intervention takes place. The modalities will include: (1) providing a stable income for women, and (2) providing a stable income and IPV trainings to women. The evaluation will take place in five departments: Cauca, Valle de Cauca, Meta, Caquetá, and Nariño.

Eligibility Criteria:
Inclusion Criteria:

* Women currently married or living together with a man as if married
* Males or females who are active within the farmer's association are eligible to participate

Exclusion Criteria:

* Women who have a husband/partner who is living elsewhere permanently