louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03222908: Perioperative Smoking Cessation Interventions
Official title: Evaluation of Surgical Outcomes in Patients Undergoing Pre-commitment and Social Contracting for Smoking Cessation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Smoking Cessation
Perioperative/Postoperative Complications
Keywords: Behavior
Perioperative/Postoperative Complications
contract agreement
implementation intentions
precommitment
smoking cessation
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2017-07-19
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized control
Primary purpose: TREATMENT

Brief summary: To assess impact of behavioral economic principles of precommitment, implementation intentions, and social contracting on smoking cessation for patients undergoing surgery.

Detailed description: Purpose \& Objective: Behavioral interventions in surgical patients are an opportunity to improve outcomes through decreased complications, with measurable economic impact. Smoking cessation is one of the most desirable long-term health behaviors for adults with potential substantial impact on postoperative complications

Study Activity \& Population Group: The investigators propose a precommitment contractual agreement implementing behavioral economic principles at the preoperative appointment for active tobacco users undergoing an operation and assessing for ability to quit smoking with testing on the day of surgery, and the durability of cessation over the postoperative course as measured with urine nicotine testing at follow up appointments. The population of interest is adults who currently smoke tobacco or vaporized nicotine who are scheduled to undergo a major operation. The control group is standard of care; prescriptive advice to quit smoking. The intervention is contract agreement for preoperative cessation.

Data Analysis \& Risk Issues: Following informed consent patients will be randomized to control or intervention groups, baseline urine nicotine tests will be performed in clinic. Urine nicotine testing will be performed on the day of enrollment, the day of their operation, and at their one-month follow up appointments. Thirty-day outcomes will be evaluated by retrospective chart review.

Eligibility criteria: Inclusion Criteria:

* active tobacco use
* preoperative appointment for an operation within 6 weeks

Exclusion Criteria:

* active enrollment in tobacco cessation program

Primary outcomes:
measure: Smoking Cessation
timeFrame: day of surgery
measure: Smoking Cessation
timeFrame: day of first postoperative appointment
Secondary outcomes:
measure: Postoperative Complications
timeFrame: 30 days postoperatively
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: DUKE DEPARTMENT OF SURGERY
name: Christopher R Mantyh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00633308: Phosphorus and Calcium Removal During Long Hemodialysis Treatment Sessions
Official title: Phosphorus and Calcium Removal During Long Hemodialysis Treatment Sessions
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Kidney Failure
Keywords: hemodialysis
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2008-03-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this sudy is to determined the effect of dialysate volume and treatment time on phosphate and calcium removal in stage V chronickidney disease patients treated by hemodialysis using the System One (NxStage Medical, Lawrence, MA)

Detailed description: Ten patients will be recruited from those routinely treated in-center or at home using the Systerm One at the clinical centers. Each patient will be studiesd on 4 separate occastions. Treatments under the following conditions will each be performed on each study patient, at least one week apart:

1. Treatment for 8 hrs uding 40L of dialysate
2. Treatment for 8 hrs using 60L of dialysate
3. Treatment for 5 hrs using 40L of dialysate
4. Treatment for 5 hrs using 60L of dialysate

Blood samples will be collected and assayed for the concentrations of urea, phosphate, calcium, bicarbonate, beta-2-microglobulin and albumin using standard assays.

Eligibility criteria: Inclusion Criteria:

* Stage V chronic kidney patients with minimal or no residual renal functin

Exclusion Criteria:

* Medically unstable
* Hematocrit less than 28%
* Hepatitis B positive, hepatitis C positive or HIV positive
* Pregnant women
* Minors below 18 years of age
* Active psychiatric disease

Primary outcomes:
measure: the effect of dialysate volume and treatment time on phosphage and calcium removal
timeFrame: 4 treatments
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Indiana University
name: Michael Kraus, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02350608: Pulse Waveform and ECG Analysis in Postoperative Cardiac Surgical Patients
Official title: Pulse Waveform and ECG Analysis in Postoperative Cardiac Surgical Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Pressure
Arrhythmias, Cardiac
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
First posted: 2015-01-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Postoperative cardiac surgery patients

Brief summary: Observational study of 20 postoperative cardiac surgery patients. On admission to the ICU the patients will receive a noninvasive monitor recording arterial pulse waveform and ECG. The monitoring will continue to the ward for two days. The data will be compared with the routine monitoring methods.

Detailed description: Observational study of 20 adult postoperative cardiac surgery patients. The observation will last from 0 to 2. postoperative day. On admission to the ICU the patients will receive a noninvasive monitor recording arterial pulse waveform and ECG. The monitoring will continue to the ward for two days. The data will be compared with the routine monitoring methods in the ICU and the ward.

Eligibility criteria: Inclusion Criteria:

* Adult cardiac surgery patients, informed consent

Exclusion Criteria:

* Poor co-operation, age less than 18 years

Primary outcomes:
measure: Detection of arrythmia
timeFrame: 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital Heart Center
Study officials:
affiliation: Tampere UH
name: Jari Laurikka, Prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT01267708: Platelet Function in Patients Undergoing PCI
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: All PCI Patients
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2010-12-28
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: To examine PLT function in all patients undergoing PCI to our center

Brief summary: The purpose of this study is to examine PLT function in PCI patients.


Eligibility criteria: Inclusion Criteria:

* All consented patients undergoing PCI

Exclusion Criteria:

* Unable to consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Medical Center
Study officials:
References:
Clinical trial NCT05681208: Microbiota Awareness and Nutrition Education Given to Mothers With Motivational Interview
Official title: The Effect of Motivational Interview, Prepared According to the Health Behavior Interaction Model, on Microbiota Awareness and Attitudes on Infant Nutrition in Primiparous Mothers Who Start Complementary Nutrition: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Microbiota
Keywords: microbiota
motivational interview
health behavior interaction model
Lead sponsor: Afyonkarahisar Health Sciences University
Sponsor class: OTHER
First posted: 2023-01-12
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Complementary nutrition is considered a critical step not only for changes in nutritional requirements but also for the formation of life-long taste preferences, nutrition and eating habits that may affect health in the long run. While the microbiota is developing, in the early stages of life, the wrong food choice negatively affects the microbiota development and causes malnutrition. In this study, the effect of motivational interviews prepared according to the Health Behavior Interaction Model on microbiota awareness and infant feeding attitude will be investigated in primiparous mothers who will start complementary feeding.


Eligibility criteria: Inclusion Criteria:

* Mothers over the age of 18,
* Ability to read and write Turkish,
* Absence of any disease in the mother and child,
* The mother's willingness to participate in the research,
* Having a healthy, vaginal and mature delivery,
* Being a primiparous mother
* Feeding only with breast milk,

Exclusion Criteria:

Mothers not participating in at least one training,

* Mothers not participating in the motivational interview,
* Desire to leave the research
* Absence of ambivalent feelings
* Inability to create a food consumption frequency scheme

Primary outcomes:
measure: Microbiota awareness scale
timeFrame: before the 1st interview
measure: Microbiota awareness scale
timeFrame: Last follow-up after 5th interview (1 month after first meeting)
measure: Microbiota awareness scale
timeFrame: Last follow-up after 9th interview(1 month after the second interview)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00894608: Letrozole Combined With Gonadotropins (Gn) for Ovarian Stimulation Undergoing in Vitro Fertilization/Intracytoplasmic Sperm Injection (IVF/ICSI) in Patients With Polycystic Ovary Syndrome (PCOS)
Official title: Letrozole Combined With Gn for Ovarian Hyperstimulation Undergoing IVF/ICSI in Patients With PCOS
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Polycystic Ovarian Syndrome
Keywords: letrozole
ovarian stimulation
PCOS
IVF-ET
Lead sponsor: Yunyang Medical College
Sponsor class: OTHER
First posted: 2009-05-07
Enrollment: 90
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether letrozole combined with gonadotropins are effective in the ovarian hyperstimulating for IVF/ICSI in patients with PCOS.

Detailed description: Polycystic ovarian syndrome (PCOS) occurs in 4% to 7% of all women of reproductive age and 20% of women presenting with anovulatory infertility. A significant proportion of these women will ultimately need assisted reproductive techniques. Various protocols of ovarian stimulation such as step up protocol, coasting, GnRH antagonists et al have been proposed for optimizing IVF results in patients with PCOS. The results of these studies have shown it not to be satisfied. The preliminary studies have proven that Letrozole, a potent and highly specific nonsteroidal aromatase inhibitor, could successfully induce ovulation in women with polycystic ovary syndrome. In spite of only a little study research of letrozole in IVF/ICSI cycle, for poor ovarian responders, addition of letrozole improved ovarian response to FSH and reduced gonadotrophin dose required for COH without having a negative impact on pregnancy rates. These reports prompted us to hypothesize that adjunctive use of letrozole in COH protocol for patients with PCOS would minimize the gonadotrophin dose, and consequently the cost, and lower the risk of OHSS in a IVF/ICSI treatment cycle.

Eligibility criteria: Inclusion Criteria:

* patients with PCOS

Primary outcomes:
measure: Cycle cancellation rate, number of oocytes retrieved, fertilization rate, embryo quality, clinical pregnancy, implantation rates and OHSS rate
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Shiyan
country: China
facility: Reproductive Medcine Research Center
state: Hubei
Study officials:
affiliation: renmin hospital,yunyang medical college
name: zhang changjun, doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05809908: Tricaprilin Phase 3 ALTER-AD (Alternative-Alzheimer Disease) Study
Official title: A Phase III, 26-Week, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Investigate the Efficacy and Safety of Daily Administration of Tricaprilin in Subjects with Mild to Moderately Severe Probable Alzheimer Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Alzheimer Disease
Lead sponsor: Cerecin
Sponsor class: INDUSTRY
First posted: 2023-04-12
Enrollment: 535
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effects of tricaprilin (20 g twice a day) on cognition, activities of daily living, resource utilisation, safety and tolerability, in subjects with mild to moderately severe probable AD.

This is a randomised, double-blind, placebo-controlled, parallel-group, multi-centre design in up to 535 participants.


Eligibility criteria: Key Inclusion Criteria:

* Mini Mental State Exam (MMSE) score between 14 to 24
* Meets diagnostic clinical criteria of probable Alzheimer's dementia according to the NIA-AA criteria
* Magnetic resonance imaging (MRI) compatible with a diagnosis of probable AD according to central MRI reader.
* Participants taking the following cholinesterase inhibitors: donepezil, galantamine, or rivastigmine; and/or memantine

Key Exclusion Criteria:

* Current use or use within 3 months of Visit 3 (Baseline), of medium chain triglyceride -containing products.
* Completed less than 6 years of formal education.
* Has any medical or neurological condition, other than AD, that could explain the subject's dementia (e.g., structural abnormality, traumatic brain injury, stroke, epilepsy, Parkinson's disease, alcohol-related dementia)
* Has a modified Hachinski Ischaemia score \> 4

Primary outcomes:
measure: Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) total score
timeFrame: 26 weeks
measure: Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC)
timeFrame: 26 weeks
Secondary outcomes:
measure: Number of Subjects with Treatment Related Adverse Events
timeFrame: 26 weeks
measure: Change From Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) score
timeFrame: 26 weeks
Other outcomes:
measure: Exploratory Biomarker Analysis
timeFrame: 26 weeks
measure: Exploratory Metabolomic Analysis
timeFrame: 26 weeks
Locations:
Study officials:
References:
Clinical trial NCT04048408: Comparison of Respiratory Muscle, Pain, Functional Performance and Cognitive Status in Obstructive Lung Diseases
Official title: Assessment of Cognitive Status, Pain, Functional Status, Postural Awareness, Respiratory Muscle Strength and Endurance in Obstructive Pulmonary Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain, Chronic
Obstructive Pulmonary Disease
Cognitive Impairment
Functional Disturbance
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2019-08-07
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Obstructive lung diseases in 18-65 years old

Brief summary: In the literature, there are a limited number of studies evaluating postural awareness, cognitive status, respiratory muscle strength and endurance, functional capacity, and pain in people with obstructive pulmonary disease, and comparing these parameters with each other and with healthy subjects, and most of the studies are on chronic obstructive pulmonary disease patients. There we will evaluate these parameters in different obstructive lung diseases and compare the findings of healthy individuals.


Eligibility criteria: Inclusion Criteria for obstructive lung diseases

1. To be diagnosed with obstructive pulmonary disease,
2. Have not experienced acute exacerbation in the last 3 months,
3. Being between the ages of 18-65,
4. Not having chronic pain problems,
5. Volunteer for research,
6. To be able to walk and cooperate.

Exclusion criteria for obstructive lung diseases

1. To be able to diagnose neurological disorder,
2. To have an advanced orthopedic disease that may affect functional capacity measurement.

Criteria for Non-Inclusion for healthy group

1. To have any cardiopulmonary disease,
2. To have an advanced orthopedic disease that may affect functional capacity measurement.

Primary outcomes:
measure: Pain Perception
timeFrame: 01.01.2019-31.08.2019
Secondary outcomes:
measure: Cognitive Function Assessment
timeFrame: 01.01.2019-31.08.2019
measure: Functional capacity assesment
timeFrame: 01.01.2019-31.08.2019
measure: Postural awareness assesment
timeFrame: 01.01.2019-31.08.2019
measure: Respiratory muscle strength and endurance measurement
timeFrame: 01.01.2019-31.08.2019
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation
state: Please Choose A State
Study officials:
affiliation: Hacettepe University
name: Ebru Calik Kutukcu, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Melda Saglam, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Deniz Inal Ince, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Hulya Arikan, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Naciye Vardar Yagli, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04174508: Non-insulino-dependant Diabetes in Infants and Teenagers
Official title: Evaluation of the Incidence of Diabetes Revealed at Pediatric Age in Reunion
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetes
Pediatric Disorder
Lead sponsor: Centre Hospitalier Universitaire de la Réunion
Sponsor class: OTHER
First posted: 2019-11-22
Enrollment: 150
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: child or adolescent with diabetes

Brief summary: The incidence of diabetes in children, which is constantly increasing worldwide is estimated in mainland France at about 15/100 000 per year with a wide disparity between countries and a north gradient South.

In Reunion island, about 30 children a year seem to reveal diabetes before the age of 18 years but no precise data has ever been published on this subject.

Indeed, while type 1 diabetes (insulin-dependent autoimmune) represents historically the majority of cases of diabetes revealed at pediatric age (about 90%), since a little more than 10 years other types of diabetes seem emerge at pediatric age. This is particularly the case of type 2 diabetes in connection with the global epidemic of obesity.

The purpose of the investigator's study is the exhaustive prospective collection of all cases of diabetes revealed before the age of 18 in the Reunion region over a period of 5 years.


Eligibility criteria: Inclusion Criteria:

* child or adolescent residing in the territory of the reunion island
* with a diagnosis that revealed diabetes according to criteria defined by WHO (World Health Organization) before 18 years of age
* Parents who signed the participation consent

Exclusion Criteria:

* Patient not residing in the usual way in Reunion island

Primary outcomes:
measure: Average annual number of new cases of diabetes according to World Health Organization (WHO) criteria
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-Benoît
country: France
facility: Groupe Hospitalier Est Réunion
city: Saint-Denis
country: France
facility: Centre Hospitalier Universitaire Réunion
city: Saint-Paul
country: France
facility: Centre Hospitalier Ouest Réunion
city: Saint-Pierre
country: France
facility: Centre Hospitalier Universitaire Réunion
Study officials:
affiliation: Centre Hospitalier Universitaire de La REUNION
name: Laure HOUDON, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04941508: Mother's Recorded Voice Versus Dexmedetomidine on Postoperative Agitation
Official title: Mother's Recorded Voice: a Neglected Therapeutic Stance for Pediatric Postoperative Agitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Agitation, Emergence
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-06-28
Enrollment: 90
Sex: ALL
Minimum age (years): 4
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the efficacy of mother's recorded voice versus dexmedetomidine injection on postoperative agitation in children undergoing elective surgery.

Detailed description: A written informed consent will be taken from the patients' legal guardians.Patients will be assigned randomly to three groups (30 subjects each) to be anesthetized and either randomly assigned to listen to the mother's recorded voice at 2 times (in the holding area 3 minutes before induction of anesthesia till induction of anesthesia is ended) and (during emergence from anesthesia till complete recovery) (Group M) or will be given a single bolus of dexmedetomidine 0.2 µ/kg IV at 2 times (in the holding area 3 minutes before induction of anesthesia) and (at the end of surgery) (Group D) or given the same volume of saline IV at 2 times (in the holding area 3 minutes before induction of anesthesia) and (at the end of surgery) (Group C).To keep blinding, group M will be injected IV with the same volume of saline at the same 2 times as in groups D \& C while in groups D \& C, headphones will be putted as in group M at the same 2 times with no recorded voice.

Eligibility criteria: Inclusion Criteria:

* Children (age 4-9 years)
* American Society of Anesthesiologists physical status (ASA) I-II who will be listed for outpatient elective surgery under general anesthesia.

Exclusion Criteria:

* Developmental delays
* Neurological diseases
* Deafness
* Hearing impairment
* Maternal mutism
* Absence of the mother

Primary outcomes:
measure: Pediatric anesthesia of emergence delirium (PAED) score
timeFrame: 2 hours Postoperative
Secondary outcomes:
measure: Face, Legs, Activity, Cry, and Consolability (FLACC) score
timeFrame: 24 hours Postoperative
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university hospital
city: Assuit
country: Egypt
facility: Omar Soliman
Study officials:
affiliation: Assiut University
name: Omar Soliman, MD
role: STUDY_DIRECTOR
References:
citation: Manyande A, Cyna AM, Yip P, Chooi C, Middleton P. Non-pharmacological interventions for assisting the induction of anaesthesia in children. Cochrane Database Syst Rev. 2015 Jul 14;2015(7):CD006447. doi: 10.1002/14651858.CD006447.pub3.