cyrilzakka/clinical-trials huggingface dataset:
The Effect of a Mediterranean Diet Intervention on Cancer-related Fatigue and Mitochondrial Function During Chemotherapy

This study will assess the feasibility of delivering an 8-week Mediterranean Diet intervention as well as the intervention's preliminary efficacy on cancer-related fatigue among patients undergoing chemotherapy, compared to usual care. In the first 4 weeks of the intervention, we will provide the participants with food and educate them on the principles and components of the Mediterranean Diet, while in the second 4 weeks participants will prepare their own food. In addition, we will evaluate changes in metabolism and mitochondrial function during 4 weeks of chemotherapy and determine how adherence to a Mediterranean diet modulates these changes during these 4 weeks.

The hypothesis is that the intervention will promote adherence to the Mediterranean Diet. The second hypothesis is that adherence will be associated with alleviation of fatigue and improvements in metabolic and mitochondrial function.


Eligibility Criteria:
Inclusion Criteria (Participants must...):

* Have a diagnosis of cancer,
* Be scheduled to receive chemotherapy and have at least 6 weeks remaining,
* Be able to speak English,
* Be willing to adhere to study procedures, and
* Be able to provide written informed consent.

Exclusion Criteria (Participants must not...):

* Be on enteral or parenteral nutrition,
* Be pregnant,
* Have distant metastases,
* Have a brain tumor,
* Have any plan to get radiation to the head,
* Have specific dietary needs that a Mediterranean diet cannot meet (e.g., allergies to nuts, gluten intolerance), or already be following the Mediterranean diet (i.e., have a score ≥10 on a modified 14-item Mediterranean Diet questionnaire).
Brain Development in Young Children Following Mild Traumatic Brain Injury - Pilot Study

Concussions (also known as mild traumatic brain injury) are common in young children. In some children, they can lead to short- and long-term difficulties. However, our knowledge of the exact consequences of injuries on young children's brains and behavior is limited. These consequences may be different in children under 6, as their brains are fragile and undergoing significant developmental changes.

The aim of this study is to determine the extent to which a concussion sustained before the age of 6 years is associated with changes in young children's brain structure, function and behaviours, using a brain imaging.

In this study, the results of a group of 30 children with a concussion will be compared to those of 30 children of the same age with an orthopaedic injury to the upper or lower limbs.


Eligibility Criteria:
Inclusion Criteria:

* Patient group with mild traumatic brain injury (mTBI) :

  1. Children aged between 36 months (3 years) and 71 months and 31 days (5 years; before their 6th birthday)
  2. Presentation to the emergency department within 48 hours post-injury
  3. Documented, unintentional traumatic event (e.g. blow, fall, etc.) resulting in non-penetrating head injury
  4. Diagnosis of mTBI (World Health Organization (WHO) paediatric diagnostic criteria)
* Control group with orthopaedic injury:

  1. Children aged between 36 months (3 years) and 71 months and 31 days (5 years; before their 6th birthday)
  2. Presentation to the emergency department within 48 hours post-injury
  3. Documented, unintentional traumatic event (e.g. blow, fall, etc.) resulting in trauma to an upper or lower limb
  4. Diagnosis of simple fracture, sprain, contusion or unspecified trauma to a limb (mild).

Exclusion Criteria:

* Diagnosis of previous TBI (any severity, any age)
* Intentional injury,
* Administration of sedative drugs that can alter brain function
* Complications following injury
* MRI contraindication,
* Parent non-fluent in French,
* Prematurity,
* Diagnosis of a severe neurological, developmental, or psychiatric disorder
* Children in foster care at the time of recruitment
Adjunctive Mild Hypothermia Therapy to Primary Percutaneous Coronary Intervention in Patients With Acute Myocardial Infarction Complicated With Shock: A Feasibility Study

The purpose of this study is evaluate the safety and feasibility of mild therapeutic hypothermia (TH) during and 12 hours after primary percutaneous coronary intervention for acute myocardial infarction complicated with shock


Eligibility Criteria:
Inclusion Criteria:

* Recent myocardial infarction: 24 hours of start pain
* Pump failure cardiogenic shock (defined as persistent hypotension, systolic BP \< 90 mmHg, despite fluids and catecholamines infusion, with tissue hypoperfusion signs
* Candidate for immediate percutaneous reperfusion
* Maximal care support: mechanical ventilation, intraaortic balloon contrapulsation

Exclusion Criteria:

* Cardiogenic shock related to mechanical complication: free wall rupture, acute mitral regurgitation, acute VSD, tamponade
* Pregnant women
* Absence of maximal support care
Effects of Intranasal Administration of Oxytocin in Adults With Prader-Willi Syndrome

The investigator thinks that the oxytocin (OT) can improve durably and significantly the behavior disorders and thus the socialization but also the satisfaction and could thus be an interesting therapeutic alternative for the patients presenting a Prader-Willi Syndrome (SPW). Although today several studies demonstrated the effects of the OT in various domains of the behavior, the investigator do not know either its specificity of action about the cerebral level, or its duration of action, or the optimal modalities of administration and in particular at patients SPW.


Eligibility Criteria:
Inclusion Criteria:

* Prader-Willi syndrome genetically confirmed
* Absence of extension of the QT interval in the electrocardiogram
* Absence of hypokalemia

Exclusion Criteria:

* Psychiatric troubles
* Anomalies of the heart rhythm in significant ECG
* Hepatic insufficiency
* Renal insufficiency
* Patients presenting a pregnancy or breast-feeding
* High sensibility to OT
* High sensibility to the excipients of the product
* Patients having family history of genetic pathology causing an extension of the interval QT
* Patients having risk factors of advanced twist
Alliance for Family Integrated Care Implementation in Neonatal Intensive Care Units

International, multi-centre, pluri-cultural, stepped wedge cluster controlled trial, to demonstrate superiority of site tailored 'Family integrated care model'(FICare), that promotes the active participation of the parents as primary caregivers of their infants in neonatal intensive care units (NICU), versus standard NICU care delivery with regards to short-term health outcomes in high-risk newborns with prolonged hospital stay.


Eligibility Criteria:
Inclusion Criteria For infants :

1. Birth weight at or below 1500 g or gestational age at or below 34 weeks.
2. Any other peri-neonatal condition anticipating NICU specialised care.
3. Admission for at least 7 days
4. Decision to provide full life support.

Inclusion Criteria For Adults

1. Willingness to spend at least 6h per day at NICU OR commitment to attend educational sessions
2. Active involvement in care for their infant at least a 7 day-period
3. No intellectual or language barriers\[A\] to understanding
4. At least one primary caregivers involved in training \[B\]
5. Signed informed consent

Exclusion Criteria For Children:

1. Decision not to provide full life support
2. Critical illness unlikely to survive
3. Scheduled for early transfer to another non-FICare hospital (expected hospital stay \<7days)

Exclusion Criteria for Parents:

1. Intellectual handicaps that makes difficult learning-understanding
2. Communication cannot be established even with translator
3. Mental, psychiatric problems or under legal supervision
4. Newborn under guardianship of social services
5. Lack of parental signed informed consent
Study Evaluating Temsirolimus in Advanced Stage Squamous Cell Carcinoma of the Head & Neck

This is an open-label, exploratory, biomarker study of intravenous temsirolimus given once weekly for 3 weeks to newly diagnosed, advanced stage head and neck cancer subjects prior to beginning their standard therapy for their specific disease. The primary objective of this study is to identify biomarkers of temsirolimus activity.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with newly diagnosed, advanced stage, head and neck squamous cell carcinoma of the oral cavity, oral pharynx, hypopharynx or larynx.
* Subjects willing to undergo tumor biopsies.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
* Age \>/= 18 years.

Exclusion Criteria:

* Subjects receiving anticoagulation therapy.
* Presence of unstable angina, recent myocardial infarction (within the previous 6 months), or use of ongoing maintenance therapy for life-threatening ventricular arrhythmia.
* Prior cancer therapy (chemotherapy, hormonal therapy, radiotherapy, immunotherapy) or investigational agent for their head and neck cancer.
Increasing Linkage to Family Planning Care for Individuals With Substance Use Disorder

This study will utilize mixed methods to develop and assess the feasibility and acceptability of a health educator intervention designed to connect patients in recovery from substance use disorder to reproductive health education and services.

Developing effective reproductive health interventions for individuals in treatment for substance use disorder is an important public health priority. In the US nearly half (45%) of all pregnancies are unplanned and studies have consistently found this rate to be much higher among individuals in substance treatment, almost 90%. There is a paucity of research on interventions to support the family planning care of this population. The primary goal of this project is to identify an innovative delivery model to address the family planning needs of individuals of reproductive age in treatment for substance use disorder at an urban integrated safety-net health system. Through the use of mixed methods this study will address the following objectives: 1) To describe the family planning experiences and needs of individuals in treatment for substance use disorders (SUD) in a representative sample of patients and 2) To assess the feasibility and acceptability of the intervention among study participants. If found to be acceptable, efficacy should be assessed in a randomized controlled trial. A navigator model such as this is generalizable and could be easily integrated into a variety of settings.

Eligibility Criteria:
Inclusion Criteria:

* In treatment for substance use disorder at one of the participating clinics; 18-44 years of age; English-speaking; not currently pregnant; able to become pregnant (e.g., no history of hysterectomy, tubal ligation, hysterectomy, menopause); not planning to leave the Denver area in the next 3 months.

Exclusion Criteria:

* currently pregnant; intoxicated or mentally impaired to the point that one is unable to voluntarily consent to participate and/or respond to the surveys.
Recruitment-to-inflation Ratio to Set Positive End-expiratory Pressure for Laparoscopic/Robotic Surgery: a Multicenter Study

The present investigation is focused to assess the effects of positive end-expiratory pressure (PEEP) on respiratory system compliance in obese patients invasive mechanical ventilation for laparoscopic or robotic surgery with pneumoperitoneum

Adult obese (body mass index ≥ 30 kg/m2) patients undergoing invasive mechanical ventilation for laparoscopic or robotic surgery with pneumoperitoneum will be enrolled, upon the acquisition of informed consent.

Will be excluded all the patients with the following conditions: American society of anesthesiologists (ASA) score ≥ 4; severe cardiopathy, intracranial hypertension, tracheostomy, previous cardio-thoracic surgery, pulmonary hypertension, broncho-pleural fistula, pulmonary emphysema, pneumothorax, chronic respiratory failure, chronic obstructive pulmonary disease, pregnancy.

Thereafter, general anesthesia will be induced, according to current clinical practice and mechanical ventilation will be commenced according to current recommendations.

Following the application of definitive pneumoeritoneum and body position, the recruitment/inflation procedure will be carried out to identify PEEP. PEEP-induced recruitment will be computed with high PEEP set at 15 cmh2o (or higher) and low PEEP set at 5 cmh2o. In case of an airway opening pressure \> 5 cmh2o, the airway opening pressure (AOP) will be set as low PEEP and the high PEEP will be set at the value corresponding to AOP+ 10 cmh20. During the procedure, tidal volume will be maintained between 6-8 ml/kg of predicted body weight. On the basis of the recruitment-to-inflation ratio (R/I), PEEP will be set as follows: low PEEP, in presence of R/I \< 0,5; high PEEP with R/I ≥ 1.5; PEEP set within low and high PEEP range on clinical decision, if R/I ≥ 0.5 and \<1.5.

After 20 min from the onset of mechanical ventilation and 1 hour from PEEP application following pneumoperitoneum and definitive body position, mechanics of the respiratory system for compliance and driving pressure will be assessed.

As an optional evaluation, a lung ultrasound examination will be performed before general anesthesia induction and 1 hour after extubation, before discharging the patient from recovery room.

During anesthesia vital signs will be continuously monitored. On the clinically judgement, arterial blood gases will be carried out across the study stages.

Eligibility Criteria:
Inclusion Criteria:

* Adult obese (body mass index ≥ 30 kg/m2) patients undergoing invasive mechanical ventilation for laparoscopic or robotic surgery with pneumoperitoneum will be enrolled, upon the acquisition of informed consent.

Exclusion Criteria:

* Will be excluded all the patients with the following conditions: american society of anesthesiologists (ASA) score ≥ 4; severe cardiopathy, intracranial hypertension, tracheosthomy, previous cardio-thoracic surgery, pulmonary hypertrension, broncho-pleural fistula, pulmonary emphysema, pnumothorax, chronic respiratory failure, chronic obstructive pulmonary disease, pregnancy.
Implementation of Physical Exercise at the Workplace (IRMA10) - Occupational Load

Static postures, repetitive work tasks, and work stress increase the risk for musculoskeletal disorders and sickness absence. Objective measurements of occupational loadings - EMG for muscular activity, EEG for cognitive activity, ECG for cardiovascular activity and heart rate variability, actigraphy for bodily movements - may provide useful early indicators of muscular, cognitive and cardiovascular overload.

The aim of this study is to investigate the effect of an individually tailored bio-psycho-social intervention strategy versus "usual care" ergonomics and standard physical exercises (reference group) on these risk factors in lab technicians with a history of work-related musculoskeletal pain.


Eligibility Criteria:
Inclusion Criteria:

* Laboratory technician
* Pain intensity \>= 3 (scale of 0-10)
* Pain duration \>= 3 months
* Pain frequency \>= 3 days per week

Exclusion Criteria:

* life threatening disease
* pregnancy
AMPLATZER Duct Occluder II Clinical Study

The objective of this study is to investigate the safety and effectiveness of the ADO II in patients with a PDA.


Eligibility Criteria:
Inclusion Criteria:

* Subject must have diagnosis of a PDA
* Subject must have a PDA \< 5.5mm in diameter by angiography
* Subject must have a PDA \< 12mm in length by angiography
* Subject must have a PDA \> 3mm in length by angiography
* Subject/legally authorized representative must give consent to participate in the clinical study
* Subject/legally authorized representative must consent to follow-up for the duration of the clinical study

Exclusion Criteria:

* Subject must not be \< 6 kilograms for the procedure
* Subject must not be \< 6 months of age
* Subject must not be ≥ 18 years of age
* Subject must not have a descending aorta \< 10mm in diameter
* Subject must not have a right to left shunt through the patent ductus arteriosus
* Subject must not have PVR above 8 Woods units or a Rp/Rs \>0.4
* Subject must not have intracardiac thrombus
* Subject must not have additional cardiac anomalies requiring surgical or interventional correction
* Subject must not have history of more than two lower respiratory infections within the last year (i.e., pneumonia)
* Subject must not have active infection requiring treatment at the time of implant
* Subject must not have contraindication to anticoagulation treatment
* Female subjects of child bearing age must not be pregnant or desire to become pregnant within six months post implant\*
* Subject must not be participating in another study for an investigational drug and/or device that may clinically interfere with this study's endpoints

  * If the subject desires to become pregnant after six months post-implant, further restriction is at the discretion of their physician.
A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Diroximel Fumarate (DRF) in Chinese and Caucasian Adult Healthy Participants

The primary objective is to evaluate the primary pharmacokinetic (PK) parameters of DRF active metabolite monomethyl fumarate (MMF) following multiple doses of DRF in Chinese and Caucasian adult healthy participants. The secondary objectives are to evaluate the secondary PK parameters of DRF active metabolite MMF following multiple doses of DRF in Chinese and Caucasian adult healthy participants, to evaluate the PK of DRF inactive major metabolite 2-hydroxyethyl succinimide (HES) following multiple doses of DRF in Chinese and Caucasian adult healthy participants and to evaluate the safety and tolerability of multiple oral doses of DRF in Chinese and Caucasian adult healthy participants.


Eligibility Criteria:
Key Inclusion Criteria:

* Have a body mass index (BMI) between 18 and 30 kilograms per meter square (kg/m\^2), inclusive.
* Negative polymerase chain reaction (PCR) test result for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at screening and Day -1.
* For Chinese participants: was born in China, and biological parents and grandparents were of Chinese origin. If living outside China for more than 5 years, must not have had a significantly modified diet since leaving China.

Key Exclusion Criteria:

* History of severe allergic or anaphylactic reactions or of any allergic reactions that, in the opinion of the investigator, are likely to be exacerbated by any component of the study treatment; or systemic hypersensitivity reactions to DRF, dimethyl fumarate (DMF), MMF, other fumaric esters, excipients in the formulation, or diagnostic agents to be administered during the study.
* Confirmed demonstration of corrected QT interval, using Fridericia's correction method, of \>450 milliseconds (ms) for males and \>460 ms for females.
* Has a history of gastrointestinal (GI) surgery (except appendectomy or cholecystectomy that occurred more than 6 months prior to screening), irritable bowel syndrome, inflammatory bowel disease (Crohn's disease, ulcerative colitis), or other clinically significant and active GI condition, per the investigator's discretion.
* Has experienced clinically significant acute GI symptoms in the judgment of the investigator within 30 days prior to admission.
* History or positive test result at screening for human immunodeficiency virus (HIV).
* Chronic, recurrent, or serious infection, as determined by the investigator, within 90 days prior to screening and between screening and Day -1.
* Current enrollment in any other drug, biological, device, or clinical study or treatment with an investigational drug or approved therapy for investigational use within 30 days prior to Day -1, or 5 half-lives, whichever is longer.
* Previous participation in this study or previous studies with DRF or DMF.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
12-Week, Double-Blind, Placebo-Controlled, Randomized Study of the Efficacy of 40 mg/Day KW-6002 in Parkinson's Disease Patients on Levodopa/Carbidopa

12-week, double-blind, placebo-controlled, multicenter, randomized study designed to evaluate the safety and efficacy of 40 mg/day istradefylline compared with placebo in subjects with OFF phenomena advanced PD who were treated with levodopa/carbidopa.

A 12-week, double-blind, placebo-controlled, multicenter, randomized study designed to evaluate the safety and efficacy of 40 mg/day istradefylline compared with placebo in subjects with OFF phenomena advanced PD who were treated with levodopa/carbidopa.

Eligibility Criteria:
Inclusion Criteria:

1. United Kingdom Parkinson's Disease Society brain bank diagnostic criteria (step 1 and 2).
2. Modified Hoehn and Yahr Scale II-IV in the OFF state.
3. Treated with levodopa/carbidopa for 1 year with a stable regimen for 4 weeks prior to randomization.
4. Taking at least 4 doses of levodopa (3 doses if at least 2 doses containing slow release formulation) per day with predictable end of dose wearing off.
5. Successfully completed Parkinson's disease patient diary training with at least 120 minutes of OFF time per day.
6. Stable regimen of other antiparkinson's disease medications for at least 4 weeks prior to randomization.
7. At least 30 years of age and able to give written informed consent.

Exclusion Criteria:

1. Treatment with liquid levodopa/carbodopa within 4 weeks of randomization.
2. Treatment with MAO inhibitors except selegiline.
3. Treatment with centrally acting dopamine antagonists within 3 months (6 months for depot preparations), e.g., antipsychotic neuroleptics, metoclopramide, buspirone, amoxapine.
4. Neurosurgical surgery for Parkinson's disease.
5. Atypical parkinsonism or secondary parkinsonism variants.
6. Diagnosis of cancer or evidence of continued cancer within 5 years of enrollment or clinically significant illness of any organ system (e.g., ALT or AST \> 1.5 times the upper limit of normal).
7. Mini-Mental Status Examination score of 25 or less.
8. History of drug or alcohol abuse or dependence within 2 years.
9. History of psychotic illness or seizures.
10. Current clinically relevant depression disorder.
11. History of neuroleptic malignant syndrome.
12. Pregnant or lactating females. Women of child-bearing potential must use reliable method of contraception.