cyrilzakka/clinical-trials huggingface dataset:
Correlation Between Clinical Measurement Scales for Gross Motor Function

Evaluating and applying an early and consistent rehabilitation approach to children with neurological impairments requires a multidisciplinary approach that involves different specialists, including pediatricians, pediatric neurologists, professional therapists, and pediatric physical therapists. Evaluation is essential to validate the judgment, monitor the source, and evaluate the mechanical function and related difficulties.


Eligibility Criteria:
Inclusion Criteria:

* children with spastic CP with the capability to keep a standing position alone for at minimum five seconds, and the grade of hypertonicity in the lower extremity varied from grade 1 to grade 2 on the Modified Ashworth Scale with the capability to collaborate and follow directives

Exclusion Criteria:

* Children were excluded If they had a serious neurological condition (epilepsy), orthopedic complications, leg surgery, botulinum toxin treatment in the lower extremity in the last 6 months before the study and suffered from advanced intellectual disability.
Cabenuva Injection Tracking in CHORUS

This is a cluster randomized trial in which clinics will be randomized to the intervention or the control arm. The purpose of this study is to assess if receiving alerts can help providers manage the scheduling of monthly cabotegravir + rilpivirine long-acting injections for the treatment of HIV.

A novel long-acting HIV antiretroviral therapy has recently been approved by the FDA: cabotegravir and rilpivirine delivered through intramuscular injection. These injections should be administered monthly, on the same day of the month as the initiation injections, up to 7 days before or after the date of the scheduled monthly injection visit.

This is a cluster randomized trial in which clinics will be randomized to the intervention or the control arm. Providers in the intervention group will receive alerts to remind them when patients are due for their injections, or if they missed their treatment window. Providers in the control group will not receive alerts and will manage injections as per their clinic's standard process. Surveys will be administered to understand the utility of the alerts for the management of these injections.

Eligibility Criteria:
Inclusion Criteria (patients):

* As per label, routine clinical care

Inclusion Criteria (clinics):

* AIDS Healthcare Foundation (AHF) Clinic
* HIV primary care clinic
* Minimum of 100 people living with HIV in care with a viral load \<50 copies/mL at the time of randomization (satellites will be included in the count of their parent clinic).
How Participants Behave and Respond on Their Own After Completing a 2-year Intervention of Calorie Restriction

The purpose of this study is to gain knowledge about how participants behave and respond on their own after completing a 2-year intervention of calorie restriction.

You will not be assigned to any particular group during the Follow-Up Study. In the Follow-Up study there is no diet intervention. You will not be asked to follow a calorie-restricted diet or any other diet.

Month 3 and Month 6 (Outpatient Visits)following procedures performed:

* Blood pressure, heart rate, temperature, Weight \& Waist Measurement
* Medication and medical history
* Blood draw (approximately ½ cup)
* DEXA and QuickScan
* Psychological assessment questionnaires reviewed for completeness
* Body Acceptability Morph Test (BAM)
* Review of 7-day food diary

Month 12 and Month 24 (Outpatient Visits) procedures performed:

* Collection of 4 urine samples
* Dosing with doubly labeled water (DLW)
* DEXA and QuickScan
* Eat breakfast and lunch
* Receive 7-day food diary
* Psychological assessment questionnaires
* Body Acceptability Morph Test (BAM)

Fourteen days after Month 12 and Month 24 (Overnight Inpatient Visits) following procedures performed:

* Collection of 2 urine samples
* Blood pressure, heart rate, temperature, Weight \& Waist Measurement
* Blood draw (approximately ½ cup)
* Medication and medical history
* Review of 7-day food diary
* Metabolic Chamber
* Resting Metabolic Rate (RMR)

Eligibility Criteria:
Inclusion Criteria:

* You may qualify to participate in this study only if you completed the CALERIE II study at Pennington Biomedical Research Center.

Exclusion Criteria:

* If you were not a participant in CALERIE II at Pennington Biomedical Research Center, you are ineligible.
Irreversible Electroporation(IRE) For Unresectable Laryngeal Neoplasms

The purpose of this study is to evaluate the safety and efficacy of irreversible electroporation (IRE) for unresectable Laryngeal Neoplasms.

By enrolling patients with unresectable Laryngeal Neoplasms adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of percutaneous IRE for unresectable Laryngeal Neoplasms.

Eligibility Criteria:
Inclusion Criteria:

* Laryngeal Neoplasms diagnosed by positive biopsy or non-invasive criteria,
* Not suitable for surgical resection,
* Eastern Cooperative Oncology Group (ECOG) score of 0-1,
* A prothrombin time ratio \> 50%,
* Platelet count \> 80x10\^9/L,
* Ability of patient to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post NanoKnife procedure,
* Able to comprehend and willing to sign the written informed consent form (ICF),
* Have a life expectancy of at least 3 months.

Exclusion Criteria:

* Cardiac insufficiency, ongoing coronary artery disease or arrhythmia,
* Any active implanted device (eg Pacemaker),
* Women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception,
* Have received treatment with an investigational agent/ procedure within 30 days prior to treatment with the NanoKnife™ LEDC System,
* Are in the opinion of the Investigator unable to comply with the visit schedule and protocol evaluations.
The Use of Dendritic Cell/Tumor Hybridomas as a Novel Tumor Vaccine in Patients With Advance Melanoma

This study aims to determine if the vacccine can be used safely in patients with advanced melanoma (cancer of the pigment cells) and whether the cells in this vaccine are capabale of producing immune responses against your own cancer.

To assess the toxicity associated with vaccination of melanoma patients with dendritic cell (DC)/tumor fusions. To determine if cellular and humoral immunity can be induced by serial vaccination with DC/tumor fusions cells. To determine if vaccination DC/tumor fusions results in a tumor response.

Eligibility Criteria:
Inclusion Criteria:

* patients with confirmed diagnoses of disseminated melanoma, with measurable and clearly progressive metastatic involevment
* Patients must be at least 18 years old
* Patients must have ECOG performance status 0-1 with greater than 9 week life expectancy
* Those patients with the following accessible tumor will be eligible: soft tissue, bone marrow or visceral lesions; Skin or superficial soft tissue, or lymph nodes amenable to resection under local anesthesia; Patients who require surgical procedures that are not considered significantly invasive but may require general anesthesia, such as thorascopic biopsy, laparascopic biopsy or mediastinal node biopsy may potentially be eligible; Malignant ascites or pleural effusion; Patients requiring major surgical intervention will be considered ineligible. Patients scheduled to undergo tumor resection for independent diagnostic or therapeutic indications may have tumor collected for the purposes of this study.
* Labs: WBC \>_ 2.0 x 10x3/uL, Bilirubin \<_2.0 mg/dL, Creatine \<_ 2.0mg/dL
* Women of childbearing age must have a negative pregnancy test and adequate contraception method(s) must be documented
* All patients must be informed of the investigational nature of this study and must give written informed consent in accordance with institutional and federal guidelines

Exclusion Criteria:

* Patients must not have received other immunotherapy treatment in the past four weeks prior to study entry
* Patients must not have received chemotherapy for three weeks prior to the first vaccination
* Patients must be without evidence of active CNS disease
* Patients must not have clinically significant autoimmune disease
* Patients must be HIV negative
* Patients must not have serious intercurrent illness such as infection requiring IV antibiotics, or significant cardiac disease characterized by significant arrhythmia, ischemic coronary disease or congestive heart failure
* Patients requiring corticosteroids for either melanoma related or co-morbid illness
A Phase II, Repeat Single Oral Dose Study of IPED2015 in Healthy Male Subjects With Erectile Dysfunction

This is a Phase II, randomised, double-blind, parallel-group, placebo-controlled study to investigate the effects of repeat single oral doses of IPED2015 in otherwise healthy male subjects with ED.

Up to 120 subjects are planned to be enrolled into 3 groups. Group 1 is planned to consist of 60 subjects, Group 2 is planned to consist of 36 subjects and Group 3 is planned to consist of 24 subjects. Groups 1, 2 and 3 will be conducted in parallel. Each subject will be dosed on four occasions. There will be three study treatments of dose 1 of IPED2015, dose 2 of IPED2015 or matched placebo. In each group, subjects will be randomised evenly to each of the three study treatments and will receive the same treatment on each visit.

The primary objective of this study is to investigate the effects of repeat single oral doses of IPED2015 on male subjects with erectile dysfunction (ED) on ability to develop and maintain an erection.

Eligibility Criteria:
Inclusion Criteria:

Otherwise healthy male subjects with ED as determined from an IIEF-5 score of \<16, with a body mass index of 18 to 35 kg/m2 (inclusive), of any ethnic origin.

Subject must have had at least one intent to have sexual intercourse during the last 3 months prior to Screening.

Exclusion Criteria:

Any significant CNS, cardiac, pulmonary, metabolic, renal, hepatic (including Gilbert's syndrome), gastrointestinal (GI) or psychiatric conditions, or history of fainting or syncope or such condition that, in the opinion of the Investigator, may place the subject at an unacceptable risk as a participant in the study, may interfere with the interpretation of safety or tolerability data obtained in this study, or may interfere with the absorption, distribution, metabolism or excretion of drugs, or with the completion of treatment according to this Protocol.

Clinically significant history of abnormal physical or mental health interfering with the study as determined by medical history and physical examinations obtained during Screening or Day -7 as judged by the Investigator (including \[but not limited to\], neurological, psychiatric, endocrine, cardiovascular, respiratory, GI, hepatic, or renal disorder).

Clinically significant abnormal laboratory results (including hepatic and renal panels, complete blood count, chemistry panel and urinalysis), 12-lead ECG and vital signs, or physical findings at Screening. In case of uncertain or questionable results, tests performed during the Screening visit may be repeated to confirm eligibility or judged to be clinically irrelevant for otherwise healthy subjects with ED.
Breathing Interventions for Relaxation: Dosing Through Extended Exhale

Breathing exercises are categorized as a mind-body practice. One in ten adults in the U.S. use breathing exercises for health purposes. The aim of this project is to examine if different slow breathing has different physiological and psychological effects.

Breathing exercises are categorized as a mind-body practice. One in ten adults in the U.S. use breathing exercises for health purposes. Slow breathing exercises are commonly used for stress reduction. Higher stress is associated with higher cardiovascular risk. Effective and standardized breathing interventions for stress reduction have not been developed or well-studied. For centuries, mind-body practitioners have proposed that, in addition to breathing slowly, extending the length of exhale relative to inhale increases the dose of relaxation. Few studies have tested this belief. The aim of this proposal is to examine if slow breathing while extending the exhale time relative to the inhale time increases physiological and psychological relaxation. The slow breathing exercises to be studied are based on breathing techniques from yoga. This is a12-week study among healthy adults randomized to daily slow breathing exercises of: (1) exhale greater than inhale versus (2) exhale equal to inhale in length. The first aim of the studies will be to compare 12 weeks of slow breathing with exhale greater than inhale on physiological stress as measured through autonomic tone. The second aim will be to compare changes in psychological stress as measured through validated stress and anxiety questionnaires. The final and third aim will be to measure the correlation between changes in physiological and psychological stress. This project will test if specific breathing techniques produce measurable and meaningful differences in stress in both healthy and disease populations. Because stress reduction is considered the major mechanism of mind-body practices, these studies will advance the field of mind-body science.

Eligibility Criteria:
Inclusion Criteria:

* Age 30 to 60 years
* English speaking

Exclusion Criteria:

* Hypertension
* Heart disease: history of coronary artery disease, myocardial infarction, significant valvular disease, or congestive heart failure
* Diabetes
* Renal disease
* Anxiety disorder
* Depression
* Other psychiatric conditions including schizophrenia or bipolar disorder
* Attention-deficit-disorder or Attention-deficit-hyperactivity disorder
* Musculoskeletal condition limiting capacity to perform simple movements such as chronic lower back pain or neck pain
* Pulmonary disorder (asthma, chronic obstructive lung disease, obstructive sleep apnea)
* Smoker
* Currently taking blood pressure medications, oral diabetic medication or insulin
* Current participation in a mind-body practice/program
* Current cancer other than non- melanoma skin cancer
* Regular swimmer
* Plays wind or brass musical instruments

After two weeks during screening period unable to:

* Breathe 8 or less a minute
* Breathe 3 or less breaths a minute
* Practiced less than 3 times a week
Evaluate Safety/Tolerability in Portuguese Participants With RRMS Transitioning From Current Therapy

The primary objective of the study is to evaluate safety and tolerability as defined by the frequency of the adverse events (AEs) of flu-like symptoms (FLS) \[chills, pyrexia, myalgia, and asthenia\], injection site reactions (ISRs), and injection site reaction pain (ISR-P), over 24 weeks of treatment (the active comparator period) with PLEGRIDY 125 microgram (μg) subcutaneous (SC) every 2 weeks versus current SC IFN-β therapy in participants with Relapsing Remitting Multiple Sclerosis (RRMS).


Eligibility Criteria:
Key Inclusion Criteria:

* A confirmed diagnosis of RRMS, as defined by McDonald criteria (2017).
* An EDSS score between 0 and 5.0.
* All female participants of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 3 months after their last dose of study treatment.
* On continual treatment for ≥6 months with a single current SC IFN-β therapy, including IFN-β-1b 0.25 mg SC every other day or IFN-β-1a 22 μg or 44 μg SC 3 times weekly

Key Exclusion Criteria:

* Known history of human immunodeficiency virus.
* Known history of or positive test result for antibodies to hepatitis C, or current hepatitis B infection (defined as positive for hepatitis B surface antigen \[HBsAg\] and/or positive for hepatitis B core antibody \[HBcAb\]) at Screening. Participants with immunity to hepatitis B from either active vaccination (defined as negative HBsAg, positive hepatitis B surface antibody \[HBsAb\], and negative HBcAb) or from previous natural infection (defined as negative HBsAg, positive HBsAb immunoglobulin G, and positive HBcAb) are eligible to participate in the study (definitions are based on the Centers for Disease Control and Prevention's interpretation of the hepatitis B serology panel \[CDC 2007\]).
* An MS relapse that has occurred within the 50 days prior to randomization and/or lack of stabilization from a previous relapse prior to randomization (Day 1).
* Any previous treatment with PLEGRIDY.

NOTE: Other protocol defined Inclusion/Exclusion may apply
Effects of TRF on Obese Patients With CKD Stage 3-4

Obesity is associated with glomerular hyperfiltration leading to renal impairment and is a risk factor for the progression of kidney disease.Weight loss can reduce proteinuria and improve eGFR.Intermittent fasting is safe and effective, and in addition to improving body shape and weight in obese patients, it can also improve glucolipid metabolism, reduce proteinuria, improve kidney function and delay the progression of kidney disease.

KDOQI clinical practice guideline for nutrition in chronic kidney disease (CKD) uses a low-protein diet to reduce renal impairment and delay progression. The current research hotspot is dietary intervention. Time-restricted feeding was used to intervene in the progression of CKD. It restrict the time of eating but not the eaten calories, which have a higher compliance and safety. Studies have shown that intermittent fasting in obese patients with CKD is not only reduce body weight, but also improves glycolipid metabolism, reduces proteinuria and delays the progression of kidney disease. Intermittent fasting is currently a scientific research hotspot, and there are few international studies on the implementation of intermittent fasting to delay the deterioration of renal function in obese CKD patients, and lack of data on Chinese patients, which has great research potential. Based on the above background, this study was conducted as an pilot clinical trial to explore the effects of intermittent fasting on obese patients with CKD and to observe its effectiveness, safety and compliance.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years
* CKD stage 3-4 and not on dialysis (eGFR: 15-59ml/min/1.73m2)
* BMI ≥ 25 kg/m2
* Good reading and comprehension skills, simple smartphone operation and no communication difficulties
* Signed informed consent

Exclusion Criteria:

* Pregnant and breastfeeding
* End-stage diseases
* Acute and active diseases such as gastrointestinal bleeding or acute infections, serious decompensation with diseases such as cirrhosis decompensation stage, malignant tumor, serious heart and lung diseases, severe primary diseases of hematopoietic system, severe hypertension (systolic blood pressure ≥200mmHg, diastolic blood pressure ≥120mmHg) and difficult to control blood pressure, within 3 months after major surgery, such as open surgery
* Mental patients
* Using medium-high doses of hormones and immunosuppressants
* Participating in other researchers
* Taking other dietary therapies, undergoing weight loss treatment
* Vegetarian
* Type 1 diabetes and type 2 diabetes using insulin
Evaluation of the Benefits of a Prehabilitation Program : Pilot Study

The process of enhancing functional capacity of the individual in anticipation of an upcoming stressor has been termed "prehabilitation". In the present pilot trial, the impact of a multimodal prehabilitation intervention composed of exercise, nutritional supplement and psychological well-being begun in the preoperative period will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years old
* Affiliated with a social security system
* Having indicated their non-opposition
* Must undergo a surgical intervention within a period of at least one month after the completion of the initial inclusion assessment and / or chemotherapy and / or radiotherapy

Non-inclusion criteria:

* Refusal of participation
* Pregnant or breastfeeding woman
* Inability to walk or initial physical assessment
* Patient under guardianship or curatorship
* Inability to complete questionnaires

Exclusion criteria:

* Cognitive disorders detected by the geriatric consultation
* Lost
* Death before surgery or chemotherapy or radiotherapy
* Shortened preoperative preparation time (\<18 days)
A Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous (SC) Administered Alirocumab in Healthy Chinese Subjects

Primary Objective:

To assess the safety and tolerability of ascending single SC doses of alirocumab in Chinese healthy subjects.

Secondary Objectives:

* To assess the pharmacokinetic profile of a single SC dose of alirocumab.
* To assess the pharmacodynamic effect of a single SC dose of alirocumab on low-density lipoprotein cholesterol (LDL-C) and other lipid parameters.
* To assess the immunogenicity of a single SC dose of alirocumab.

Ascending dose design includes 3 dose levels. Tolerance data up to at least 14 days post dosing from at least 6 subjects of the previous cohort will be reviewed before proceeding with a next dose. Total duration of the study per subject is approximately 15 weeks (including screening period).

Eligibility Criteria:
Inclusion criteria:

* Healthy male or female subjects.
* Aged 18 to 45 years old.
* Low-density lipoprotein cholesterol \>100 mg/dL (2.59 mmol/L).

Exclusion criteria:

* Subjects with any history or presence of clinically relevant illness.
* Serum triglycerides \>200 mg/dL (2.26 mmol/L) measured after at least 10 hour fasting.
* Use of a medication or nutraceutical in order to alter serum lipids within 4 weeks prior to screening, including but not limited to statins, ezetimibe, fibrates, niacin, or bile acid resins. Use of probucol within 8 weeks prior to screening.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Eicosanoids in Human Heart Failure

Our translational project aims to evaluate the role of eicosanoids in human HF.

Heart failure (HF) is the leading cause of cardiovascular hospitalizations, and with its increasing prevalence, the healthcare systems face a heart failure pandemic. Translational research findings improve our knowledge of pathophysiology and uncover therapeutic targets in HF. Natriuretic peptides represent such examples as routinely used in diagnostics and therapeutics (neprilysin inhibitor). Despite modern pharmacotherapy, including angiotensin receptor-neprilysin inhibitor (ARNI) and sodium-glucose cotransporter-2 inhibitors (SGLT2i), the prognosis of patients, especially with advanced heart failure, remains poor. Furthermore, most medication is limited in the late stages of HF due to their hypotensive effects.

Basic research has been focused on the eicosanoids - metabolites of cytochrome P-450 (CYP)-dependent epoxygenase pathway of arachidonic acid (AA), especially epoxyeicosatrienoic acids (EETs). In the preclinical studies, it was shown that EETs importantly contribute to the regulation of cardiovascular and renal function and exert organ-protective actions. It was also proposed that intrarenal EETs operate as an endogenous compensatory system opposing increased renin-angiotensin system (RAS) activity. EETs are rapidly transformed by soluble epoxide hydrolase (sEH) to biologically inactive dihydroxyeicosatrienoic acids (DHETs). The role of eicosanoids in human HF, however, remains unclear.

Our translational project (Eicosanoids in Human Heart Failure) aims to evaluate the role of eicosanoids in human HF.

Eligibility Criteria:
Inclusion Criteria:

* Heart failure

Exclusion Criteria:

* None