louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00968500: Understanding the Psychosocial Needs of Parents Who Have Lost a Child to Cancer
Official title: Understanding the Psychosocial Needs of Parents Who Have Lost a Child to Cancer
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Parents Who Have Lost a Child to Cancer
Keywords: Grief
bereavement
questionnaires
09-107
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Dana-Farber Cancer Institute
name: Ohio State University
name: University of Memphis
name: University of Southern California
First posted: 2009-08-31
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Bereaved parents will be identified through death records kept by the Department of Pediatrics and cross-referenced with the deceased child's MSK medical record.

Brief summary: The purpose of this study is to understand the experiences and needs of parents who have lost a child to cancer. This will aid us in developing an intervention that may help parents cope with their loss.


Eligibility criteria: Inclusion Criteria:

* Loss of a child to cancer between 6 months and 6 years ago
* Loss of a child between the ages of 6 months and 25 years
* Biological or adoptive parent or stepparent
* Parent must be age 18 or over
* In the judgment of investigators/consenting professionals able to comprehend English to complete study assessments
* To be eligible for the qualitative interview, participants more score of 19 or less (\< 19)or 34 or greater (\> 34) on the PG-13 to qualify

Exclusion Criteria:

* Significant psychiatric disturbance sufficient, in the investigator's judgment, to preclude completion of the assessment measures, interview or informed consent.

Primary outcomes:
measure: Identify the unique qualitative themes related to finding meaning among parents who lost a child to cancer to inform development of a conceptually sound meaning-centered grief intervention.
timeFrame: 2 years
Secondary outcomes:
measure: Determine differences in qualitative themes of meaning in parents in the high and low Prolonged Grief Disorder subgroups to help select a target population for a meaning-centered grief intervention.
timeFrame: 2 years
measure: Explore and identify factors associated with bereaved parents' psychosocial service underutilization to guide the development of an acceptable and feasible meaning-centered grief intervention format.
timeFrame: 2 years
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: NCI Clinical Center
state: Maryland
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Christian Nelson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02832700: Casein Glycomacropeptide in Healthy Subjects
Official title: Casein Glycomacropeptide in Healthy Subjects - Anti-inflammatory and Microbiome Modulating Effects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Disease
Keywords: glycopeptides
dietary proteins
whey protein
caseinomacropeptide
antiinflammatories
human microbiome
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Arla Foods
First posted: 2016-07-14
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Casein glycomacropeptide (CGMP) has anti-inflammatory properties in experimental rodent colitis and using human in vitro inflammation models. Its use as a food ingredient has proven safe and with no influence on dietary intake. In a pilot study the investigators found, that orally administered CGMP seems to have a beneficial effect comparable to that of mesalazine in active distal ulcerative colitis.

The investigators now wish to evaluate the effects in healthy subjects by studying the anti-inflammatory and microbiome modulating properties and by assessing possible changes in gastrointestinal symptoms.


Eligibility criteria: Inclusion Criteria:

* Caucasians
* Body Mass Index 18.5-25.0

Exclusion Criteria:

* Within 3 months: Acute intestinal disease (diarrhea more than 3 days in a week or bloody stools), hospital admission or antibiotic treatment.
* Chronic inflammatory disease or intestinal disease, including Crohn's disease, ulcerative colitis, celiac disease, rheumatoid arthritis or any other autoimmune joint disease, multiple sclerosis or any intestinal surgery apart from appendectomy.
* Pregnant or nursing.
* Unable to speak and understand Danish.

Primary outcomes:
measure: Number of participants with changes in systemic inflammation markers and cellular immune response
timeFrame: 4 weeks
Secondary outcomes:
measure: Number of participants with changes in the intestinal microbiome
timeFrame: 4 weeks
measure: Number of participants with changes in gastrointestinal symptoms
timeFrame: 4 weeks
Other outcomes:
measure: Compliance
timeFrame: 4 weeks
measure: Intestinal butyrate production
timeFrame: 4 weeks
Locations:
city: Aarhus C
country: Denmark
facility: Department of medicine V (Hepatology and Gastroenterology)
Study officials:
affiliation: University of Aarhus
name: Hendrik A Vilstrup, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT04009200: The Effect of Preoperative Anxiety on Postoperative Delirium in Children
Official title: The Effect of Preoperative Anxiety on Postoperative Delirium in Children Who Will Undergo Circumcision Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preoperative Anxiety
Postoperative Delirium
Lead sponsor: Ankara Diskapi Training and Research Hospital
Sponsor class: OTHER
First posted: 2019-07-05
Enrollment: 60
Sex: MALE
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: First 60 patients coming to the operating room who met the study criteria

Brief summary: Investigation of the effect of preoperative anxiety on postoperative delirium in children who will undergo circumcision operation

Detailed description: In order to determine the effect of circumcision on preoperative anxiety and postoperative delirium, patients will be divided into two groups who will undergo circumcision surgery and who will undergo inguinal hernia surgery.

Modified Yale Preoperative Anxiety Scores (m-YPAS), Visual Analogue Scale Anxiety (VAS-anxiety) will be evaluated when patients are taken to the preoperative waiting room.

After awakening, patients will be taken to the postoperative wake-up room where Pediatric Anesthesia Recovery Delirium Scores (PAED), Recovery Agitation 5-point Scores (EA), FLACC scores will be evaluated every 5 minutes and mean arterial pressure, pulse, SPO2 values will be recorded. Duration of stay in recovery unit will be recorded

Eligibility criteria: Inclusion Criteria:

* ASA 1-2
* Elective circumcision or elective inguinal hernia

Exclusion Criteria:

* Chronic diseases
* Development disability
* Prematurity
* Neurological diseases
* Psychoactive medication use
* Hearing/ visual impairment
* History of surgery

Primary outcomes:
measure: Preoperative anxiety difference between groups
timeFrame: Before premedication, in operating room
Secondary outcomes:
measure: emergence agitation difference between groups
timeFrame: postoperative every 5 minutes during 20 minutes
measure: effect of parent's anxiety on child's anxiety
timeFrame: before premedication
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Diskapi Yildirim Beyazit Training Research Hospital
state: Altındag
Study officials:
affiliation: Diskapi Yildirim Beyazit Training Education Hospital
name: Ilkay Baran Akkuş
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06892600: Combined General and Spinal Anesthesia Compared to General Anesthesia During Laparoscopic Surgery : a Randomised Controlled Trial
Official title: Combined General and Spinal Anesthesia Compared to General Anesthesia During Laparoscopic Surgery : a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laparoscopic Abdominal Surgery
Spinal Anesthesia
General Anesthesia Using Endotracheal Intubation
Keywords: laparoscopy
combined spinal and general anesthesia
abdominal laparoscopic surgery
opioid consumption
spinal anesthesia
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2025-03-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two parallel groups - intervention and control group
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn if combining spinal and general anesthesia is better than general anesthesia alone for abdominal laparoscopic surgery in adults. The main questions it aims to answer are:

Does combining spinal and general anesthesia provide better stability compared to general anesthesia alone during abdominal laparoscopic surgery? Does combining spinal and general anesthesia lead to less opioid consumption compared to general anesthesia alone for abdominal laparoscopic surgery?

Participants will:

Be randomized and allocated to either spinal and general anesthesia (combined) group vs general anesthesia (control) group In the combined group, participants will be given a spinal anesthesia followed by general anesthesia, compared to general anesthesia alone in the control group.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiology (ASA) 1-2
* BMI ≤ 30 kg/m2
* Adults (18-64 years old) who will undergo elective abdominal laparoscopic surgery (digestive surgery, gynecologic surgery or urologic surgery)
* Willing to participate in this study

Exclusion Criteria:

* Cardiovascular disease (uncontrolled stage 2 hypertension, AV block, valvular heart disease, heart failure or arrythmia)
* Cerebrovascular disease (within \< 3 months)
* Infection at the proposed site of spinal injection
* Coagulopathy
* Elevated intracranial pressure
* Severe kidney or liver dysfunction

Drop out criteria:

* Anesthesia duration \> 6 hours
* Intraoperative emergency
* Conversion to open laparotomy
* Spinal complications (shock, anaphylaxis, seizure or high spinal)
* Failed spinal (2 attempts)

Primary outcomes:
measure: Opioid consumption
timeFrame: Throughout the surgery
measure: Post-operative pain score
timeFrame: Within 24 hours after surgery
measure: Hemodynamic stability
timeFrame: During the surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Cipto mangunkusumo general hospital
Study officials:
affiliation: Indonesia University
name: Pryambodho Pryambodho, MD, Anesthesiologist
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06334900: Retrospective Analysis of the French National Cohort of Patients With GAD Antibodies and Cerebellar Ataxia
Official title: Retrospective Analysis of the French National Cohort of Patients With GAD Antibodies and Cerebellar Ataxia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: GAD-receptor Antibodies-associated Encephalitis
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2024-03-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with cerebellar ataxia and GAD antibody

Brief summary: Glutamic acid decarboxylase (GAD) is an enzyme whose function in the body is to decarboxylate glutamate to GABA. GAD65 antibodies (GAD65Ab) have been associated with type-1 diabetes (80% of new-onset patients) and various neurological conditions, mainly stiff-person syndrome (SPS/PERM), cerebellar ataxia (CA), limbic encephalitis (LE) and temporal lobe epilepsy. These syndromes all seem to result from a reduced transmission of GABA. These neurological conditions are rare and can cause symptoms like confusion, memory loss, muscle stiffness, muscle spasms, behavioural disorders, and pharmacoresistant epilepsy. When finding high levels of GAD65-Ab in the serum, a cerebrospinal fluid (CSF) sample should be taken to look for oligoclonal IgG bands and intrathecal GAD-Ab production to prove an auto-immune cause for the various neurological symptoms.


Eligibility criteria: Inclusion Criteria:

* neurological symptoms with GAD antibody
* GAD antibody in sera and/or CSF
* patient with cerebellar ataxia

Exclusion Criteria:

* tested positive to another antibody.
* no data
* any test in paraneoplastic neurological syndrome and autoimmune encephalitis center

Primary outcomes:
measure: GAD Patient
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital Neurologique Pierre Wertheimer / Groupement Hospitalier Est
Study officials:
References:
Clinical trial NCT00360100: Zmax Pediatric Vs Adult Concentration For The Treatment Of Acute Otitis Media
Official title: A Randomized, Multicenter, Comparative Study To Assess Tolerability Of A Single Oral 60 Mg/Kg Dose Of Zmax (Pediatric Concentration) Vs. Zmax (Adult Concentration) In Pediatric Patients With Acute Otitis Media
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Otitis Media
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-08-03
Enrollment: 120
Sex: ALL
Minimum age (years): 3
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Assess tolerability of different dosing formulations (adult versus pediatric).


Eligibility criteria: Inclusion Criteria:

* Have clinical signs/symptoms of AOM in at least 1 ear

Exclusion Criteria:

* Known or suspected hypersensitivity, or intolerance to azithromycin or other macrolides or to any penicillin, beta-lactam antibiotic or beta lactamase inhibitor
* Previously diagnosed disease(s) of immune function
* Treatment with any systemic (intravenous, intramuscular, oral) antibiotic for any indication within 7 days prior to enrollment

Primary outcomes:
measure: Treatment-related vomiting on Day 1, which is based directly on the collected observed or voluntarily reported vomiting.
Secondary outcomes:
measure: Time-to-vomiting (in minutes) will be measured for all vomiting episodes that occur within the 60-minute observation period post-dosing on Day 1.
measure: Frequency of the number of days of treatment-related vomiting by treatment group for subjects in the All Treated population.
measure: Frequencies of occurrence, by day, of treatment-related vomiting.
measure: Investigator and Sponsor assessment of clinical response.
Other outcomes:
Locations:
city: Bardstown
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Springfield
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Cordoba
country: Argentina
facility: Pfizer Investigational Site
city: Santiago
country: Chile
facility: Pfizer Investigational Site
state: RM
city: Independencia
country: Chile
facility: Pfizer Investigational Site
state: Santiago
city: Providencia
country: Chile
facility: Pfizer Investigational Site
state: Santiago
city: San Jose
country: Costa Rica
facility: Pfizer Investigational Site
city: Santo Domingo
country: Dominican Republic
facility: Pfizer Investigational Site
state: DN
city: Ciudad Guatemala
country: Guatemala
facility: Pfizer Investigational Site
city: Guatemala
country: Guatemala
facility: Pfizer Investigational Site
city: Ciudad de Panama
country: Panama
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01823900: Safety and Pharmacokinetic Comparison of Co-administration and a Combination Drug of Rosuvastatin and Olmesartan in Healthy Male Volunteers
Official title: A Randomized, Open Label, Single-Dose, 2-Way Cross-over Clinical Trial to Compare the Safety and Pharmacokinetic Characteristics of Combination of Rosuvastatin and CS-866 and DWJ1276 in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Pharmacokinetics
Lead sponsor: Severance Hospital
Sponsor class: OTHER
First posted: 2013-04-04
Enrollment: 58
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study investigates safety and pharmacokinetic comparison of DWJ1276, a combination drug of Rosuvastatin and Olmesartan (test formulation), and co-administration of Rosuvastatin and Olmesartan (reference formulation) for single dose in healthy volunteers


Eligibility criteria: Inclusion Criteria:

* Healthy male volunteers between the ages of 20 and 50 and within 20% of their ideal body weight, without congenital abnormality or chronic disease

Exclusion Criteria:

* History of cardiovascular, pulmonary, renal, endogenous, gastrointestinal, hematologic, neurologic or hemorrhagic disease;
* Clinically significant findings on routine laboratory (hematology, serum chemistry and urinalysis) or ECG tests;
* Use of prescription drugs in the 14 days immediately prior to starting the study that had the potential to interact with the study medication;
* Use of any substance that could induce or inhibit drug metabolism enzymes

Primary outcomes:
measure: Profile of Pharmacokinetics
timeFrame: 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72 hours post-dose
Secondary outcomes:
measure: Profile of Pharmacokinetics
timeFrame: 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72 hours post-dose
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References:
citation: Son H, Roh H, Lee D, Chang H, Kim J, Yun C, Park K. Pharmacokinetics of rosuvastatin/olmesartan fixed-dose combination: a single-dose, randomized, open-label, 2-period crossover study in healthy Korean subjects. Clin Ther. 2013 Jul;35(7):915-22. doi: 10.1016/j.clinthera.2013.05.016. Epub 2013 Jun 27.
Clinical trial NCT00163800: Outcome Predictors in Acute Brain Injury
Official title: Outcome Predictors in Acute Brain Injury, A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Brain Injury
Keywords: Outcome predictors
Acute brain injury
Lead sponsor: Bayside Health
Sponsor class: OTHER_GOV
First posted: 2005-09-14
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: This study will attempt to evaluate clinical, laboratory and radiographic parameters together to assess heir values in outcome prediction from brain injury. Patients will be followed up for a period of 6 months, following admission to ICU, to assess outcome, using the Extended Glasgow Outcome Score (GOSE).

We hypothesise that it is possible to reliably predict outcome in brain injury from the current investigations we have at our disposal.

Detailed description: Design- A prospective clinical trial of patients admitted to intensive care with acute brain injury due to trauma.

Setting- Intensive Care Unit of the Alfred Hospital Clinical Examination- Day 4 and day 8, ICU consultant to assess prognosis and score patient.

Electrophysiology- Day 4 and day 8, SSEP and EEG. Interpretation by person blinded to the patient.

CT Brain- Day 1, day 4 and day 8. Interpretation by radiologist blinded to the patient.

Blinding- Persons blinded to the patients will make all interpretations of investigations. Mode of brain injury will be made available.

Follow up of patients- Structured interviews by telephone will be performed at 6 months post injury with the patient alone, relatives/ friend/ carer alone or patient and relatives/ friend/ carer. These will be performed in relation to the Extended Glasgow Outcome Scale (GOSE).

Statistics- The positive and negative predictive values for the tests will be determined.

Eligibility criteria: Inclusion Criteria:

* Glasgow Coma Scale \< 9 post resuscitation
* Intubated and ventilated
* Traumatic brain injury

Exclusion Criteria:

* Pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Bayside Health
name: Warwick Butt, FRACP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01300000: Effects of Early Nutrition on Growth
Official title: Effects of Early Nutrient Intake on Growth and Body Composition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant Newborn
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
Collaborators: name: Institute of Child Health
First posted: 2011-02-21
Enrollment: 649
Sex: ALL
Minimum age (years): 1
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of the study is to compare the growth of infants fed standard infant formula with infants fed a reduced calorie and protein formula.


Eligibility criteria: Inclusion Criteria:

* good health
* singleton birth with gestational age 37-42 weeks
* infant's birth weight \>or = to 2500 grams
* exclusive breastfeeding or exclusively formula feeding
* within a defined geographical boundary
* mother has no problems communicating in English

Exclusion Criteria:

* adverse maternal, fetal or infant medical history
* congenital disease or malformation affecting growth or development
* illness or social problems in mother or infant
* temporary residents

Primary outcomes:
measure: Weight gain
timeFrame: 1- 365 days
Secondary outcomes:
measure: Gastrointestinal tolerance
timeFrame: 1-365 days
measure: Infant Anthropometrics
timeFrame: 1 - 365 days; 24 months
Other outcomes:
measure: Vascular
timeFrame: at 24 months
measure: Maternal Anthropometrics
timeFrame: at 24 months
Locations:
city: London
country: United Kingdom
facility: MRC Childhood Nutrition Research Center, Institute of Child Health
Study officials:
affiliation: Abbott Nutrition
name: Barbara Marriage, PhD
role: STUDY_CHAIR
References: