louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06500429: A Study to Evaluate the Safety and Efficacy of NG101 in Adult Participants Receiving a GLP-1 Agonist
Official title: A Proof-of-Concept, Randomized, Double-blind, Placebo-controlled Study to Investigate the Safety and Efficacy of Oral NG101 in the Treatment of Side Effects in Healthy Adult Participants Administered a Single Subcutaneous Dose of a Glucagon-Like Peptide 1 Agonist
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Overweight and Obesity
Healthy
Lead sponsor: Neurogastrx, Inc.
Sponsor class: INDUSTRY
First posted: 2024-07-15
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Adult participants with BMI between 22 - 35 kg/m2 will be enrolled and randomized to receive either NG101 (20 mg BID) or placebo for 5 days beginning on Day 1. On Day 2, all participants will receive a single subcutaneous injection of a GLP-1 agonist (semaglutide). Participants will remain at the clinical research unit for the duration of the treatment period.

The goal of this clinical trial is to evaluate the safety and efficacy of NG101 compared to placebo, when also administered along with a GLP-1 agonist, in the management of gastrointestinal side effects commonly associated with GLP-1 agonists for overweight or obesity. Adverse event information will be collected. GI-specific questionnaires will be used to capture additional details if GI-related adverse events are reported.


Eligibility criteria: Inclusion Criteria:

* Healthy adult
* Male or female
* BMI between 22 - 35 kg/m2 at screening

Exclusion Criteria:

* Presence or history of illness that might confound the results of the study or pose an -
* History of presence of gastroparesis, gallbladder disease, acute or chronic pancreatitis, or surgery of the abdomen
* History or presence of Type 1 or Type 2 diabetes

Primary outcomes:
measure: Duration of GI-related adverse events
timeFrame: 96 hours following GLP-1 agonist injection
measure: Severity of GI-related adverse events
timeFrame: 96 hours following GLP-1 agonist injection
Secondary outcomes:
measure: Number of TEAEs of GI-related adverse events
timeFrame: 96 hours following GLP-1 agonist injection
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Celerion
state: Arizona
Study officials:
References:
Clinical trial NCT00385229: Post Term Pregnancy - Induction of Labor or Monitoring of Pregnancy
Official title: Post Term Pregnancy - Induction of Labor or Monitoring of Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perinatal Morbidity
Keywords: Asphyxia neonatorum
Birth Injury
Meconium Aspiration Syndrome
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian University of Science and Technology
First posted: 2006-10-09
Enrollment: 508
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Post term pregnancy is a risk pregnancy. Aim of the study was to investigate whether induction of labor at gestational age 289(41 weeks+2 days) reduces neonatal morbidity compared to expectant management. Secondary aims was to assess the effect on mode of delivery and maternal complications, as well as assess women's views and experiences.

Our 0-hypothesis was that induction of labor at gestational age 41+2 did not result in better outcome of pregnancy, measured as perinatal morbidity.

Following inclusion, women were randomly allocated to induction of labor or to monitoring of pregnancy every third day until delivery


Eligibility criteria: Inclusion criteria:

* Routine ultrasound scan and delivery at St.Olav's Hospital
* Ability to speak Norwegian
* Singleton pregnancy
* Gestational age 289 +/- 2 days
* Cephalic presentation

Exclusion criteria:

- prelabor rupture of membranes

Primary outcomes:
measure: Neonatal morbidity
timeFrame: peri- en postnatal
Secondary outcomes:
measure: Maternal complications
timeFrame: peri- and postnatal
measure: Mode of delivery
timeFrame: at birth
measure: women's view
timeFrame: postpartum
measure: Women's experiences
timeFrame: perinatal
measure: Hormone levels
timeFrame: perinatal
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Department of Obstetrics, St.Olavs Hospital, Trondheim University Hospital
Study officials:
affiliation: Department of Obstetrics, St.Olavs Hospital, Trondheim University Hospital
name: Runa Heimstad, MD
role: STUDY_DIRECTOR
References:
citation: Heimstad R, Skogvoll E, Mattsson LA, Johansen OJ, Eik-Nes SH, Salvesen KA. Induction of labor or serial antenatal fetal monitoring in postterm pregnancy: a randomized controlled trial. Obstet Gynecol. 2007 Mar;109(3):609-17. doi: 10.1097/01.AOG.0000255665.77009.94.
citation: Middleton P, Shepherd E, Morris J, Crowther CA, Gomersall JC. Induction of labour at or beyond 37 weeks' gestation. Cochrane Database Syst Rev. 2020 Jul 15;7(7):CD004945. doi: 10.1002/14651858.CD004945.pub5.
Clinical trial NCT02553629: Effect of Deep Neuromuscular Block on Surgical Conditions in Morbidly Obese Patients
Official title: Effect of Depth of Neuromuscular Block on Intraoperative Surgical Conditions as Determined by the Leiden Surgical Rating Scale in Morbidly Obese Patients Undergoing Laparoscopic Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Surgical Conditions
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
name: Medical Center Haaglanden
First posted: 2015-09-17
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized control trial (RCT) that studies the surgical conditions during moderate and deep neuromuscular blockade in 100 morbidly obese patients receiving elective laparoscopic surgery for bariatric surgery.


Eligibility criteria: Inclusion Criteria:

* ASA I-III
* BMI \> 34 kg/m2
* Elective bariatric surgery.

Exclusion Criteria:

* Known or suspected neuromuscular disorders impairing neuromuscular function
* Allergies to muscle relaxants, anesthetics or narcotics
* A(family) history of malignant hyperthermia
* Women who are or may be pregnant or are currently breast feeding
* Renal insufficiency, as defined by serum creatinine x 2 of normal, or urine output \< 0.5 ml/kg/h for at least 6 h.

Primary outcomes:
measure: Surgical Rating
timeFrame: intraoperative
Secondary outcomes:
measure: Extubation
timeFrame: intraoperative
measure: Pain
timeFrame: postoperative, for up to 2 hours
measure: Respiration
timeFrame: 2 hours postoperative
measure: Mean Arterial Blood Pressure
timeFrame: 2 hours postoperative
Other outcomes:
Locations:
city: The Hague
country: Netherlands
facility: Medisch Centrum Haaglanden / Nederlandse Obesitas Kliniek
state: Zuid Holland
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
state: Zuid-Holland
Study officials:
affiliation: LUMC
name: Albert Dahan, MD, PhD, professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02206529: Enhancing Family Based Treatment of Childhood Obesity Through Social Networks
Official title: Enhancing Family Based Treatment of Childhood Obesity Through Social Networks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Obesity
Keywords: obesity
child
weight management
behavioral
social networks
social support
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2014-08-01
Enrollment: 25
Sex: ALL
Minimum age (years): 7
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to develop a Social Network Engagement (SNE) Intervention that will be integrated into a standard treatment program for childhood overweight. The investigators will conduct a pilot trial of SNE to assess feasibility and to estimate its effectiveness compared with historical controls who received standard treatment. The historical controls will be participants in the FOCUS trial (Family Overweight: Comparing Use of Strategies; NCT00746629).


Eligibility criteria: Inclusion Criteria Children

* Age 7-13 years
* At or above the 85th percentile for age- and gender-specific BMI

Parents

• At least one overweight parent (BMI\>25.0)

Parents and children

* English-speaking and at least at a second-grade reading level
* Live \<50 miles from the treatment site.

Exclusion Children

* Conditions known to promote obesity (e.g., Prader-Willi),
* Participation in another weight control program
* Recently started taking weight-affecting medications (e.g., stimulants).

Parents and children

* Disability or illness that would preclude them from engaging in at least moderate-intensity physical activity,
* Current or prior diagnosed eating disturbance
* Thought disorder, suicidality, or substance abuse disorder

Primary outcomes:
measure: Child BMI Z-score
timeFrame: 20 weeks after baseline
measure: Child BMI Z-score
timeFrame: One year post-treatment
Secondary outcomes:
measure: Peds QL (child self-report and parent report)
timeFrame: 20 weeks after baseline
measure: Parent BMI
timeFrame: 20 weeks after baseline
measure: Peds QL (child self-report and parent report)
timeFrame: One year post-treatment
measure: Parent BMI
timeFrame: One year post-treatment
Other outcomes:
measure: SSQ (Social Support Questionnaire-Short Form)
timeFrame: 20 weeks after baseline
measure: QRI (Quality of the Relationship Index)
timeFrame: 20 weeks after baseline
measure: SPSI-R (Social Problem-Solving Index-for Research)
timeFrame: 20 weeks after baseline
measure: Behavioral Skill Assessment
timeFrame: 20 weeks after baseline
measure: WMSI (Weight Management Support Index)
timeFrame: 20 weeks after baseline
Locations:
Study officials:
affiliation: Group Health Research Institute
name: Paula Lozano, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06230692: Diaphragm Structure and Function in Children
Official title: Understanding the Influence of Diaphragm Structure and Function on the Control of Breathing During Exercise in Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Respiratory Muscle Training
Keywords: Diaphragm
Control of Breathing
Exercise
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2024-01-30
Enrollment: 13
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this research is to study the feasibility of a specific training program for the breathing muscles (inspiratory muscle training) and the effects on how breathing is regulated during exercise in typically developing children.

Detailed description: During the first study visit, participants will undergo a series of pulmonary function and muscle performance tests followed by treadmill walking trials at different speeds with concurrent expired gas analysis via a face mask. The participants will then perform a training program for the breathing muscles at home for 6 weeks. The research team will follow up each week via telehealth visits to support training. After the 6-week training program, participants will return in-person for a follow-up visit and will undergo the same series of assessments as the first visit.

Eligibility criteria: Inclusion Criteria:

* Age range 6-12 years of age

Exclusion Criteria:

* History of neuromuscular, cardiac, or pulmonary disease
* Known intellectual or developmental problems that would preclude the ability to assent
* Ruptured eardrum
* Recent injury or condition (less than 6 months ago) that precludes strength testing or walking
* Recent (less than 2 weeks ago) or current respiratory or other type of illness

Primary outcomes:
measure: Percent completion
timeFrame: 6 weeks
measure: Adherence to treatment protocol
timeFrame: 6 weeks
Secondary outcomes:
measure: Maximal inspiratory pressure (measured in cm H2O)
timeFrame: 6 weeks
measure: Diaphragm thickness (measured in mm)
timeFrame: 6 weeks
measure: Exercise ventilation
timeFrame: 6 weeks
Other outcomes:
measure: 6-minute walk test distance (measured in m)
timeFrame: 6 weeks
Locations:
city: Baltimore
country: United States
facility: University of Maryland, Baltimore
state: Maryland
Study officials:
affiliation: University of Maryland, Baltimore
name: Simon Ho
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02975492: Assessing the Impact of a Mode of Vitamin D Supplementation (Sequential Dose vs Daily Dose) on the Incidence of Hypercalciuria in Subjets Aged From 2 to 18 Years
Official title: Evaluation de l'Impact d'un Mode de supplémentation en Vitamine D (Dose séquentielle vs Dose Quotidienne) Sur l'Incidence de l'Hypercalciurie Chez Des Sujets Des départements du Gard et de l'Hérault agés de 2 à 18 Ans. Etude contrôlée randomisée en 2 Groupes parallèles
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Transient Hypercalciuria
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2016-11-29
Enrollment: 280
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Recommendations for vitamin D supplementation for subjets between 2 and 18 years offer strong sequential doses of vitamin D: 2 times 100 000 units in spaced winter period of 3 months. Data from the literature show a further increase in the incidence of oxalo-calcium stones in children and adolescents associated with hypercalciuria with training Randall plates, essential step lithogenesis calcium oxalate. Knowing the links between vitamin D and urinary calcium excretion, these data lead to the question of increased sensitivity in some children with vitamin D, sensitivity could explain these situations with hypercalciuria increase the gallstone risk. This increased sensitivity to vitamin D may unmask particularly if inputs of high doses of vitamin responsible then a transient hypercalciuria with development of microcrystals.


Eligibility criteria: Inclusion Criteria:

* Children aged 2 to 17 years included
* Obtaining informed consent of the parents signed
* Participants aged 18 years included

Primary outcomes:
measure: Changes from calcium level in urines at day 7, day 14 and day 28
timeFrame: day 7, day 14 and day 28
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Pediatric department
city: Nîmes
country: France
facility: Pediatric department
Study officials:
References:
Clinical trial NCT02584192: Efficacy of Early Home-based Cardiac Rehabilitation Program for Patients After Acute Myocardial Infarction
Official title: Efficacy of Early Home-based Cardiac Rehabilitation Program for Patients After Acute Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Myocardial Infarction
Lead sponsor: Guangzhou General Hospital of Guangzhou Military Command
Sponsor class: OTHER
First posted: 2015-10-22
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to evaluate the effect of this CR program on the improvement of myocardial function using the three-dimensional speckle tracking echocardiography (3D-STE) in AMI patients.

Detailed description: The effect of early short-term home-based cardiac rehabilitation (CR) program on left ventricular function in acute myocardial infarction (AMI) patients is not clear yet.

Eligibility criteria: Inclusion Criteria:

* Being aged 18-65 years with a confirmed AMI diagnosis
* Being suitable for the CR program
* Undergoing PCI at the entry

Exclusion Criteria:

* Known ischemic heart disease, heart valvular lesions, intra-ventricular conduction disturbances, malignant arrhythmia, cardiac shock, and poor echocardiographic conditions to take STE examination

Primary outcomes:
measure: myocardial function using the three-dimensional speckle tracking echocardiography (3D-STE)
timeFrame: Change from baseline strain parameters at four-week follow-up
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Dibben G, Faulkner J, Oldridge N, Rees K, Thompson DR, Zwisler AD, Taylor RS. Exercise-based cardiac rehabilitation for coronary heart disease. Cochrane Database Syst Rev. 2021 Nov 6;11(11):CD001800. doi: 10.1002/14651858.CD001800.pub4.
Clinical trial NCT04756492: Prognostic Factors for Treatment Responses in Patients With Active Lupus Nephritis at Sohag University Hospital
Official title: Prognostic Factors for Treatment Responses in Patients With Active Lupus Nephritis at Sohag University Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: We Aim to Examine the Predictors of Sustained Complete Renal Remission in Patients With Lupus Nephritis at Sohag University Hospital
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-02-16
Enrollment: 100
Sex: ALL
Minimum age (years): 14
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: o Patients diagnosed with LN at Sohag University Hospital

Brief summary: Systemic lupus erythematosus (SLE) is an autoimmune disease which may give rise to multiple organ involvement because of immune complex deposits. Lupus nephritis (LN) is one of the severe manifestations of systemic lupus erythematous (SLE) and a common cause for end-stage renal disease, significantly affecting the survival of SLE patients Immunosuppressive treatment is the major therapy for active LN. Generally, at least six months are needed to assess treatment responses Failure to respond to immunosuppressive therapy can lead to a worsening of renal function

Detailed description: This study will be prospectively analyzing the clinical data of LN patients who received standard immunosuppressive therapy and were regularly followed up at our center for more than six months. These patients will not change treatment regimen during the six months.

As remission is an independent predictor of good long term prognosis in lupus nephritis. We aim to examine the predictors of sustained complete renal remission in patients with lupus nephritis at Sohag University Hospital and to analyze data of lupus nephritis patients to find parameters that can predict remission and improve outcome of our cases

Eligibility criteria: Inclusion Criteria:

* o Patients diagnosed with LN at Sohag University Hospital

  * Patients in regular follow-up for more than six months after immunosuppressive therapy
  * Baseline urinary protein/creatinine ratio (UPCR) more than 1 g/g
  * Baseline C3 less than 55 mg/ dl
  * No change in immunosuppressive therapy within six months

Exclusion Criteria:

* o Patients with incomplete pathological data and the number of glomeruli being \<10 per biopsy specimen

  * Age \<14 years old End-stage renal disease (ESRD) status on admission (sustained estimated glomerular filtration rate (eGFR) \<15 ml/min per 1.73m2)
  * Patients with advanced comorbid conditions like advanced liver cirrhosis or heart failure or malignancy

Primary outcomes:
measure: complete renal response
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University
Study officials:
References:
Clinical trial NCT05360992: Pulmonary Embolism: Mechanism and Therapeutic Innovation
Official title: Pulmonary Embolism: Mechanism and Therapeutic Innovation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Embolism
Keywords: pulmonary embolism
chronic thromboembolic pulmonary hypertension
mechanism
therapy
outcome
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2022-05-04
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The consecutive hospitalized patients or outpatients diagnosed with PE or CTEPH.

Brief summary: To explore the pathogenesis, therapy and outcome of pulmonary embolism (PE) and chronic thromboembolic pulmonary hypertension (CTEPH).

Detailed description: The study recruited consecutive outpatients or hospitalized patients diagnosed with pulmonary embolism (PE cohort) and chronic thromboembolic pulmonary hypertension (CTEPH cohort). The follow-up of all patients was performed annually by phone or outpatient visit. The main outcomes were bleeding, recurrent events, and survival. The objective of the study was to explore the pathogenesis, therapy and outcome of PE and CTEPH.

Eligibility criteria: Inclusion Criteria:

* All hospitalized patients or outpatients diagnosed with PE or CTEPH;
* Age ≥18.

Exclusion Criteria:

* Refused informed consents.

Primary outcomes:
measure: Recurrent Incidence of Patients
timeFrame: through study completion, an average of 1 year.
measure: Bleeding Rate of Patients
timeFrame: through study completion, an average of 1 year.
measure: Survival Rate of Patients
timeFrame: through study completion, an average of 1 year.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Lu Hua, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wu Y, Hu S, Yan XX, Peng FH, Tan JS, Guo TT, Gao X, Hua L. Chronic Thromboembolic Pulmonary Hypertension in Females: Clinical Features and Survival. J Cardiovasc Dev Dis. 2022 Sep 16;9(9):308. doi: 10.3390/jcdd9090308.
Clinical trial NCT03685292: Behavioral Studies and Practices
Official title: "Fraud Case Study" - The Tone At The Top and What Constitutes Criminal Behavior.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Behavioral
Lead sponsor: Foundation of iAesthetics and Neurobiology
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2018-09-26
Enrollment: 37
Sex: ALL
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: African-American Cased-Based

Brief summary: The focus of this study is to evaluate whether a new fraud material will be suitable for a technological device and or software. \*\*\*For consultation purposes only.\*\*\*


Eligibility criteria: Inclusion Criteria:

* College Student

Exclusion Criteria:

* Age Over 40

Primary outcomes:
measure: Questionnaire/Screening
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: The Southern University
state: Louisiana
Study officials:
References: