cyrilzakka/clinical-trials huggingface dataset:
Safety and Tolerability, Pharmacokinetic and Pharmacodynamic Study With IZD334

This is a first in human (FIH), single-centre, double -blind, randomised, cross-over, SAD followed by a MAD study of IZD334 conducted in healthy adult participants as well as an open-label cohort in adult patients with CAPS. The study is designed to evaluate the safety, tolerability, PK, PD, and food effect of IZD334 in healthy adult participants, and to evaluate the safety, tolerability, PK, PD, and preliminary clinical efficacy of IZD334 in adult patients with CAPS.


Eligibility Criteria:
Inclusion Criteria: (Healthy Volunteers)

* Healthy male or female volunteers, aged 18 to 65 years (inclusive at the time of informed consent)
* Participants must be in good general health, with no significant medical history, have no clinically significant abnormalities on physical examination at Screening and/or before administration of the initial dose of study drug
* Participants must have a Body Mass Index (BMI) between ≥18.0 and ≤32.0 kg/m2 at Screening
* Participants must have clinical laboratory values within normal range as specified by the testing laboratory, unless deemed not clinically significant by the Investigator or delegate

Inclusion Criteria: (CAPS Patients)

\*Patients with a confirmed diagnosis of CAPS (FCAS or MWS) aged 18 to 65 years (inclusive at the time of informed consent)

Exclusion Criteria: (Healthy volunteer)

* Pregnant or lactating at Screening or planning to become pregnant (self or partner) at any time during the study, including the follow-up period
* Prior or ongoing medical conditions, medical history, physical findings, or laboratory abnormality that, in the Investigator's (or delegate's) opinion, could adversely affect the safety of the participant
* Presence of any underlying physical or psychological medical condition that, in the opinion of the Investigator, would make it unlikely that the participant will comply with the protocol or complete the study per protocol
* Blood donation or significant blood loss within 60 days prior to the first study drug administration

Exclusion Criteria: (CAPS Patients)

* Live vaccinations within 3 months prior to Screening, for the duration of the study and for up to 3 months following the last dose of study drug;
* Positive QuantiFERON test at the Screening visit or within 2 months prior to Screening.
Intracranial Atherosclerosis and Depression After Coronary Artery Bypass Graft

The purpose of the study is to examine if blood flow in the brain before coronary artery bypass graft surgery has an effect on depression after surgery.

The main hypothesis of the study states that pre-surgical blood flow in the brain will be an independent risk factor for depression after surgery after adjusting for other risk factors such as gender, pre-CABG depression, social support, medical comorbidity burden, socioeconomic status, and neuroticism.


Eligibility Criteria:
Inclusion Criteria:

* Age: 40 years or older
* Will be having CABG surgery at the Yale New Haven Hospital
* Be able to provide informed consent
* Have a household telephone
* A fluent English speaker, and possessing no communication barrier
* Be able to come to the study site or to have the study team come to his/her home.
* Has a family member or partner/ friend who could provide collateral information

Exclusion Criteria:

* Has had previous CABG surgery
* History of dementia diagnosis or cognitive impairment (CDR \>/= 1)
* Auditory or visual impairment that would interfere with study procedures
* Active alcohol or substance abuse problem based CAGE-AID (endorsing two or more items)
* History of Bipolar Disorder, Schizophrenia, Schizoaffective Disorder, or any Psychotic Disorder by medical history or self-report.
* Presence of non-cardiovascular conditions likely to be fatal within 1 year
A Study to Determine the Bioequivalence of SCH 900068 Compared to Marketed Products (Protocol No. P07551)

The intent of this study is to demonstrate that single doses of the Final Market Image (FMI) ezetimibe/atorvastatin 10mg/10mg and 10mg/80mg fixed dose combination (FDC) tablets are bioequivalent to the same doses of ezetimibe (ZETIA®) and atorvastatin (LIPITOR®) that are coadministered as individual tablets in healthy adults.


Eligibility Criteria:
Inclusion Criteria

* Healthy adult males and females age 18-55 years
* Body mass index (BMI) between 18-35 kg/m\^2
* Clinical laboratory tests (complete blood count, blood chemistry, and urinalysis), electrocardiogram, and vital signs must be within normal limits
* Must agree to refrain from consumption of red wine, grapefruit, and grapefruit-containing products, orange and apple juices, and orange- and apple-containing products from beginning approximately 2 weeks prior to administration of the initial dose of study drug, throughout the study (including the washout interval between treatment periods), and until the poststudy visit

Exclusion Criteria

* Female subjects who are pregnant, intend to become pregnant (within 3 months of ending the study), or are nursing/breastfeeding.
* Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug
* History of any infectious disease within 4 weeks prior to drug administration
* Have demonstrated allergic reactions or hypersensitivities or intolerance to atorvastatin or other 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors, ezetimibe, or any component/excipient of the study drug or other food, drug, atopic reactions or asthmatic episodes which, in the opinion of the investigator and sponsor, interfere with their ability to participate in the trial.
* Have a history of prior myopathy or abnormality in liver function studies with statin therapy.
* Are positive for hepatitis B surface antigen, hepatitis C antibodies, or HIV.
* Have donated blood in the past 60 days
* Consume excessive amounts, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, or other caffeinated beverages per day.
Medication Treatment for Opioid Use Disorder in Expectant Mothers: Infant Neurodevelopmental Outcomes Sub-study

This is a sub-study of NIDA CTN Protocol 0080: Medication Treatment for Opioid Use Disorder in Expectant Mothers (MOMs; Unique protocol ID: 2019-0429-1). Caretakers of the infants delivered by MOMs participants will be offered the opportunity to enroll in this sub-study, which is designed to evaluate the impact of extended-release buprenorphine (BUP-XR), relative to sublingual buprenorphine (BUP-SL), on infant neurodevelopment. The additional data collected in this sub-study will be combined with data from the main MOMs trial.


Eligibility Criteria:
Inclusion Criteria:

* The participant must be the caretaker of an infant that was delivered as part of the MOMs trial (Unique protocol ID: 2019-0429-1).

Exclusion Criteria:

-
Efficacy of Stellate Ganglion Block in Children With Autistic Disorder

The goal of this clinical trial is to explore efficacy of stellate ganglion block Children with Autistic Disorder. The main question it aims to answer is:

Can stellate ganglion block improve the Autistic Disorder in children? Children with Autistic Disorder will be divided into the control group and experimental group evenly. All the patients were provided with routine therapy, while the patients in the experimental group were given stellate ganglion block. The Childhood Autism Rating Scale of the two groups of patients before and after treatment are evaluated.

Autistic Disorder in children is becoming increasingly more. The goal of this clinical trial is to explore efficacy of stellate ganglion block Children with Autistic Disorder. The main question it aims to answer is:

Can stellate ganglion block improve the Autistic Disorder in children? Children with Autistic Disorder will be divided into the control group and experimental group evenly. All the patients were provided with routine therapy, while the patients in the experimental group were given stellate ganglion block. The Childhood Autism Rating Scale of the two groups of patients before and after treatment are evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as Autistic Disorder.
* Aged between 6 years old and 12 years old.
* No contraindications to stellate ganglion block.

Exclusion Criteria:

* Other significant physical or neurodevelopmental disorders.
* Other significant medical conditions
Study of Maternal Hydration on the Increase of Amniotic Fluid Index

The purpose of this study is to determine the effect of maternal hydration with oral isotonic solution and water on amniotic fluid (AF) index in women with normohydramnios.

Objective: To determine the effect of maternal hydration with oral isotonic solution and water on amniotic fluid (AF) index in women with normohydramnios.

Subjects and Methods: Women with normal AF index and gestational age between the 33 and 36 weeks without maternal complications were randomized into three groups (isotonic solution, water, control). The isotonic solution and water groups were instructed to drink 1.5L of respective solution; the control group was instructed to drink 200mL of water. AF index was measured before and after hydration. The investigator performing the AF index was blinded to the subject's group.

Results: Ninety-nine women completed the study without any maternal adverse effects. The mean increase in amniotic fluid index after hydration was significantly greater in the isotonic solution and water groups (12.1mm, p=0.02; 13.1mm, p=0.05; respectively) than the control group (1.4mm, p=0.74). There was no significant difference between the isotonic solution and water groups. Hydration with isotonic solution and water improved the chance of 20% of increase of amniotic fluid index in 10.2 (95% CI 1.9-98.9) and 6.0 (95% CI 1.0-45.5) times respectively.

Conclusion: Maternal hydration with isotonic solution or water increased AF index in women with normohydramnios.

Eligibility Criteria:
Inclusion Criteria:

* gestational age between 33 and 36 weeks
* singleton pregnancy
* intact membranes
* initial AF index between 5 and 95 per cent

Exclusion Criteria:

* no maternal complications
* no fetal structural malformation
* no evidence of fetal distress on nonstress test
Adenotonsillectomy and Obstructive Sleep Apnea Study

Adenotonsillectomies are one of the most common childhood surgeries and are first-line treatment to correct childhood obstructive sleep apnea syndrome (OSAS). This is a study comparing patients with and without OSA looking at the length of stay following adenotonsillectomy and the factors affecting length of stay.


Eligibility Criteria:
Inclusion Criteria:

1. history of snoring/gasping/ or pause in breathing reported by caregivers.
2. age 3-6 years old
3. undergoing adenotonsillectomy only no concurrent surgery
4. scheduled as outpatient and plan for discharge home

Exclusion Criteria:

1. Preoperatively requiring additional respiratory support
2. scheduled for concurrent surgery that could increase total general anesthetic time
3. recurrent adenotonsillitis as sole indication for surgery
Enhancing Walking in People With Incomplete Spinal Cord Injury: a Pilot Study

The research proposed here will determine the effect of a novel treadmill gait training strategy using a robotic gait trainer (the Lokomat) on functional ambulation in people with SCI. The effect of the new therapy will be evaluated by analyzing changes in functional ambulation and gait patterns during walking.

Community-dwelling individuals with motor-incomplete spinal cord injury will be recruited. In total, 20 participants will be recruited and randomly assigned to one of 2 types of body-weight supported treadmill training (BWSTT) with the Lokomat, which differ only in the level of assistance that the Lokomat provides to the leg movements while walking. Therapy for both groups will take place 3 times/week for 12 weeks. During each session, participants will first complete a 10-minute warm-up period followed by 45 minutes of the assigned therapy. Rest breaks will be provided as needed, but participants should complete 45 minutes of walking per session.

Eligibility Criteria:
Inclusion Criteria:

1. motor-incomplete SCI due to non-progressive lesion (e.g. trauma, ischemia) at least 12 months ago
2. 19 to 65 years of age
3. use of standing or walking as part of typical activities of daily living
4. controlled spasticity (stable administration of anti-spasticity medication) for the duration of the study

Exclusion Criteria:

1. lesion below 11th thoracic level (lower motoneuron injury)
2. weight greater than 300 lbs or height greater than 6'1"
3. femur length \<35 cm or \>47 cm and body weight \>150 kg
4. cardiac, musculoskeletal, or other uncontrolled health condition (e.g. orthostatic hypotension, osteoporosis) for which exercise or treadmill activity is contra-indicated
5. existing skin irritation or open wounds/sores in lower extremity areas in contact with the leg cuffs of the Lokomat or body weight support harness
6. existing cognitive impairment (as indicated by a Cognitive Capacity Screening Examination (CCSE) score of less than 24 out of 30)
7. participation in rehabilitation therapy or other research study with exercise or mobility outcomes
Do we Intubate Faster With the Videolaryngoscope?

The Aim of the study was to determine the impact of the videolaryngoscpe on the time needed to intubate.

This was a Prospective, randomized, simple blinded study. The participants intubated patients for surgery under general anesthesia either with direct laryngoscpy or with videolaryngoscopy.

Intubation on full stomach is at high risk of pulmonary suction. It must be quick, as this risk increases with the time needed to intubate. Videolaryngoscope (VL) is recommended in case of difficult airway. Yet, its interest in full stomach remains unclear, as the time needed to intubate with a VL is variable in literature. The Aim of the study was to determine the impact of the videolaryngoscpe on the time needed to intubate.

This was a Prospective, randomized, simple blinded study. The participants intubated patients for surgery under general anesthesia either with direct laryngoscpy or with videolaryngoscopy.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years-old;
* ASA status 1 to 3;
* General anesthesia and intubation.

Exclusion Criteria:

* Difficult intubations criteria.
Effects of Open and Laparoscopic Gastrointestinal Surgery on Gastrointestinal Function

A prospective study to compare the postoperative ileus in open and laparoscopic gastrointestinal surgery through the determination of the time the patient takes to pass flatus, pass stool, bowel movement, oral intake, the time of hospital stay and total hospital costs. Postoperative ileus (POI) is one of the major focus of concern for surgeons, hospital executives, quality assurance directors as well as patients because of its role in causing patient distress, discomfort, and morbidity, leading to an increase in the duration of hospital stay and cost of care.

All patients aged ≥18 years scheduled to undergo gastric and colorectal cancer resection surgery at the Department of Gastrointestinal Surgery, West China Hospital between 2019 to 2020 will be screened for eligibility. The inclusion criteria for the study will be the patient undergoing elective gastric cancer surgery, have the American Society of Anesthesiologist (ASA) grade ≤ III, alert consciousness, and BMI, and accurate preoperative diagnosis of gastric adenocarcinoma on the basis of computed tomography CT scan report, Gastroscopy and Histopathological reports. Exclusion criteria will be those who cannot participate in study assessments owing to the language barrier, dementia or postoperative delirium; previously received palliative surgery, develops early postoperative bowel obstruction, Anastomotic leakage or Gastroparesis, those requiring reoperation for any other indication before the commencement of formal assessment for PPOI. Those requiring more than 30 minutes of adhesiolysis. Each patient will be approached during preoperative counseling on an individual basis by one of the authors (YZ)

Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥18 years scheduled to undergo elective abdominal surgery
* American Society of Anesthesiologist (ASA) grade ≤ III
* Alert consciousness
* Any BMI
* Accurate preoperative diagnosis on the basis of necessary reports

Exclusion Criteria:

* Cannot participate in study assessments owing to the language barrier, dementia or postoperative delirium
* Previously received palliative surgery
* Develops early postoperative bowel obstruction, Anastomotic leakage or Gastroparesis
* Those requiring reoperation for any other indication before the commencement of formal assessment for POI
* Those requiring more than 30 minutes of adhesiolysis
* Emergency cases
* American Society Anesthesia (ASA) class IV or V patients, pregnancy, patient with abdominal carcinomatosis or radiation enteritis, inoperable cases due to metastasis, patients simultaneously enrolled in any other competing for clinical study and violation of study protocol by the patient or patient care team
A Prospective, Multi-Center, Single-Arm Study of the Veriset™ Hemostatic Patch in Controlling Bleeding in Soft Tissue

The objective of this study is to determine the safety of Veriset™ Hemostatic Patch when used during non-emergent, open, soft tissue surgery where a topical hemostatic agent would be used.


Eligibility Criteria:
Inclusion Criteria:

* Subject or authorized representative has provided informed consent.
* Subject is ≥ 18 years old.
* Subject is scheduled for nonemergent surgery where a topical hemostatic agent would be used to control bleeding emanating from a tissue bed following organ dissection or removal or a bleeding tumor tissue bed following resection or dissection, via an open approach.
* Subject is willing and able to comply with all aspects of the treatment and evaluation schedule.
* Subject has an appropriate Target Bleeding Site (TBS) during the surgical procedure.
* TBS bleeding assessment is Type 2 or 3 (refer to table in protocol).

Exclusion Criteria:

* Subject is pregnant (documented by a positive pregnancy test) or is actively breast-feeding.
* Subject has an estimated life expectancy of less than 6 months.
* Subject is scheduled for another planned surgery and the subsequent surgery would jeopardize the previous application of study treatment.
* Subject is undergoing emergency surgery, i.e. lifesaving procedures performed where patient is in imminent danger of death.
* Subject has participated in an investigational drug or device research study within 30 days of enrollment that would interfere with the study.
* Subject has an active local infection at the TBS.
* The investigator determines that participation in the study may jeopardize teh safety or welfare of the subject.
Photobiomodulation for Cancer-Related Cognitive Impairment

This is a single site, pilot randomized, double blinded control trial designed to assess changes in cognitive symptoms in cancer survivors with cancer-related cognitive impairment. Patients will be randomized into one of two Arms: Intervention or Control.

* Arm A: Intervention Group: Use of the THOR LED Photobiomodulation helmet 3x per week for 6 weeks. Helmet will be in 'therapeutic setting', 35mW/cm2 = 42J/cm2
* Arm B: Control Group: Use of the THOR LED Photobiomodulation helmet 3x per week for 6 weeks. Helmet will be in 'placebo setting', 0mW/cm2 = 0J/cm2

This study has been designed to assess the hypothesis that Photobiomodulation can have a positive impact on cognitive symptoms in cancer survivors with cancer-related cognitive impairment.

30 participants will be recruited for this study, 15 per group. Self-report questionnaires assessing cognitive concerns, cognitive abilities, quality of life, depression, and anxiety will be administered at three timepoints through the study Baseline, End of Study Visit and 1 Month Follow Up


Eligibility Criteria:
Inclusion Criteria:

* Adults ≥ 18 years
* Previous diagnosis of stage I-III non-central nervous system solid tumor malignancy, Hodgkin, or Non-Hodgkin lymphoma
* Completed cancer treatment (chemotherapy and/or radiation) more than 6 months ago but less than 5 years ago (Current concurrent endocrine therapy, anti-HER-2 therapy allowed, or other stable maintenance therapies (such as rituximab) will be allowed.
* Self-reported cognitive complaints (score ≤ 54 on the Functional Assessment of Cancer Therapy-Cognition, Version 3, Perceived Cognitive Impairment subscale)
* Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
* Ability to read, write and understand either English OR Spanish.

Exclusion Criteria:

* Current pregnancy or nursing status
* Current use of Photobiomodulation (PBM) (for any reason)
* A lifetime history of any brain tumor or central nervous system metastasis
* Previous use of intrathecal chemotherapy, chimeric antigen receptor treatment (CAR-T), or stem cell/marrow transplant
* Known history of other neurological conditions involving impaired cognitive function (such as Alzheimer's Disease and related dementias, Parkinson's Disease, or Multiple Sclerosis).
Comparing Several Strategies to Manage Moderate Acute Malnutrition Among Children From 6 to 24 Months Old

The aim of this open-label randomized controlled trial conducted in four African countries (Madagascar, Niger, Central African Republic and Senegal) is to compare three strategies of renutrition for moderate acute malnutrition (MAM) in children based on modulation of the gut microbiota with enriched flours alone, enriched flours with prebiotics or enriched flours coupled with antibiotic treatment. Cognitive development of children (Senegal) will also be studied and compared.

The main objective of this study is to improve the nutrition strategy used to take in charge moderate acute malnutrition (MAM) which is the major milestone before severe malnutrition. This will be based on the modulation of the gut microbiota with adjunct product added to standard nutrition flours.

The purpose of the MALINEA study is to compare three management strategies for Moderate Acute Malnutrition (MAM) in children aged between 6 months and 2 years old on recovery defined by a weight/size gain at 3 months.

The 3 groups will be compared on several anthropometric measurements \[Weight, length, Mid Upper Arm Circumference (MUAC)\], clinical characteristics, adherence and tolerance to interventions between before and after a 3 months intervention Cognitive development of children (Senegal) will also be studied and compared, at inclusion, 3 months and 6 months after inclusion.

The investigators will also investigate the microbiomes of malnourished children at inclusion and at 3 and 6 months after inclusion to compare it to the ones of normonourished children.

Eligibility Criteria:
Inclusion Criteria:

* Children aged from 6 to 24 months olds.
* Moderate acute malnutrition defined by a -3 ≤ Weight/Height z-score \< -2 SD.
* Written informed consent of parents or legal guardian.
* Child able to be brought back to the centre on the two following days of inclusion.
* Child able to be followed up during at least three months.

Exclusion Criteria:

* Severe malnutrition defined by a mid upper arm circumference \< 115 mm OR Weight/Height z-score \< -3 SD OR presence of nutritional oedema.
* Clinical complications or according to the physician any clinical sign requiring care outside of the recruitment centre (referral to specialised centre or hospitalisation)
* Diarrhea with mucus and bloody stools.
* Current incompatible treatment : Antacids, Cetirizine, Digoxin, Ergotamine, Azidothymidine.
* Known hypersensitivity to macrolides or albendazole (or one of its components)
* Known allergy to enriched flours or prebiotics used in the study, or one of its components.