louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00397826: Evaluation of the Effects of Simvastatin 40mg
Official title: Evaluation of the Effects of Simvastatin 40 Mg on Lipid Profiles and Specified Circulatory Parameters in Normotensive Hypercholesterolemia Patients(MK-0733-265)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypercholesterolemia
Lead sponsor: Cardinal Tien Hospital
Sponsor class: OTHER
First posted: 2006-11-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To collect lipid-lowering response data with the use of simvastatin 40 mg tablet in patients with hypercholesterolemia.

Detailed description: This is an open-label, prospective study to investigate lipid-lowering efficacy and sympathetic response of normotensive hypercholesterolemia patients after receiving simvastatin 40 mg once daily for 3 months.

The total duration of the study will be approximately 13 weeks, comprising of a 1-week (or 4 weeks?) screening period and a 12-week active treatment period. 20 hypercholesterolemia patients with normal blood pressure will be enrolled into treatment group.

Eligibility criteria: Inclusion Criteria:

* Male or female patient, \>18 years of age
* Patients with hypercholesterolemia who meet the following lipid criteria:

  1. primary cholesterolemia: total cholesterol\>=240 mg/dl or ldl-c \>= 160 mg/dl
  2. secondary cholesterolemia (patients with cad, dm): ldl-c\>=130 mg/dl
* The patient is willing to follow an NCEP therapeutic lifestyle changes (tlc) or similar cholesterol-lowering diet throughout the duration of the study

Exclusion Criteria:

* Congestive heart failure (NYHA class III or IV), uncontrolled cardiac arrhythmia, unstable angina
* Hypertension (based on the atp 3 guidelines)
* Taking potent lipid-lowering agents
* Unstable diabetes (hba1c \>9%) or newly diagnosed (within 3 months), or a change in anti-diabetes medications within 3 months of screening

Primary outcomes:
measure: Total cholesterol, ldl-c, hdl-c, and triglycerides
timeFrame: after 12 weeks treatment
Secondary outcomes:
measure: Pulse wave velocity
timeFrame: after 12 weeks
measure: Baroreflex sensitivity
timeFrame: after 12 weeks treatment
measure: Serum nitrite, nitrate and urine c-gmp levels after 12 weeks treatment
timeFrame: after 12 weeks treatment
Other outcomes:
Locations:
Study officials:
affiliation: Cardinal Tiem Hospital
name: Dong Feng Yeih, MD,Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00065026: Increasing Physical Activity Levels in Low-Income Women
Official title: Environmental Approaches to Reducing Obesity: Increasing Physical Activity Levels in Low-Income Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
First posted: 2003-07-18
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Primary purpose: PREVENTION

Brief summary: Regular physical activity is important for good health. Women, particularly women with low incomes, have many personal barriers to regular physical activity. The purpose of this study is to reduce environmental barriers to physical activity for women in two specific low-income neighborhoods (in Louisville, KY) by providing opportunities for safe physical activity and addressing barriers such as lack of child care. Two groups of women will have pretest information (cholesterol, blood sugar, blood pressure, percent body fat, height, weight, waist and hip measurements) collected and the same information 6 months later at post-test. One group will have access to multiple physical activity opportunities in their neighborhood and at the neighborhood community center. An advanced registered nurse practitioner will facilitate the activity opportunities. The groups will be compared on their pretest and post-test information to see if the group with the physical activity opportunities has increased physical activity as measured by pedometer and self-report questionnaire, and to see if there are changes in the measures tested at pre and post (measures that may be improved by regular physical activity).


Eligibility criteria: live in one of two specific low-income neighborhoods in Louisville, KY

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
Study officials:
References:
Clinical trial NCT05543226: The Effect of PHGG-rich Enteral Nutrition to on the Infection in Liver Transplant Recipients: A Prospective, Double-blind, Randomized Controlled Study
Official title: The Effect of PHGG-rich Enteral Nutrition to on the Infection in Liver Transplant Recipients: A Prospective, Double-blind, Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Infections
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2022-09-16
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To known the effect of PHGG-rich enteral nutrition to on the infection in liver transplant recipients


Eligibility criteria: Inclusion Criteria:

1. liver transplant recipients
2. age from 18 to 80 years old
3. APACHE II score \>12
4. There is an indication for enteral nutrition and it is expected to require oral or tube feeding for more than 7 days
5. there is no intra-abdominal infection or bloodstream infection

Exclusion Criteria:

1. Severe cardiac, kidney and lung dysfunction
2. bowel obstruction, intestinal perforation, intestinal leakage before operation
3. Roux and Y anastomosis during liver transplant

Primary outcomes:
measure: Incidence of infections after liver transplantation
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00669526: Clinical and Cost Effectiveness of Brief Cognitive-Behavioral Therapy (CBT) for Pediatric Internalizing Disorders
Official title: Clinical and Cost Effectiveness of Brief CBT for Pediatric Internalizing Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Depression
Anxiety
Keywords: anxiety
depression
Major Depressive Disorder
child
adolescent
CBT
Cognitive-Behavioral Therapy
primary care
Lead sponsor: Robert Wood Johnson Foundation
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: William T. Grant Foundation
First posted: 2008-04-30
Enrollment: 60
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This project assesses the clinical and cost effectiveness of brief cognitive-behavioral therapy (CBT) for depressed (ages 11-17) and anxious (ages 8-17) youths seen for services in pediatric primary care. This study is designed to compare the impact of brief CBT delivered on-site in pediatric primary care to referral to specialty mental health care (SMHC), as well as obtain an estimate of the total costs of the CBT protocols for depression and anxiety and the cost-effectiveness of the protocols compared to referral to and utilization of SMHC services.


Eligibility criteria: Inclusion Criteria for depression:

* Ages 11 to 17 years
* Meet diagnostic criteria for Major Depression, Dysthymia, or Minor Depression
* Live with a legal guardian

Inclusion Criteria for anxiety:

* Ages 7 to 17 years
* Meet full or probable (missing one, non-core symptom) diagnostic criteria for Separation Anxiety Disorder, Generalized Anxiety Disorder, Social Phobia, or Specific Phobia
* Live with a legal guardian

Exclusion Criteria:

* Require treatment other than brief CBT (namely, youths with bipolar disorder, psychosis, active suicidal ideation with plan, post-traumatic stress disorder, substance dependence, or mental retardation
* Experience of recent physical or sexual maltreatment
* Serious or unstable physical illness
* Current participation in an alternate, active intervention for the target condition of interest

Primary outcomes:
measure: Clinician Global Impressions - Improvement (CGI-I)
timeFrame: weeks 12 and 24
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: SDSU/UCSD Joint Doctoral Program in Clinical Psychology
name: V. Robin Weersing, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Weersing, V. R., Gonzalez, A., Campo, J. V., & Lucas, A. N. Brief Behavioral Therapy for Pediatric Anxiety and Depression: Piloting an Integrated Treatment Approach. Cognitive and Behavioral Practice (in press), 2008.
Clinical trial NCT02897726: A Study to Evaluate the Safety and Pharmacokinetics of NVP-1402
Official title: A Clinical Trial to Evaluate the Pharmacokinetics and Safety of NVP-1402 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: NVP Healthcare
Sponsor class: INDUSTRY
First posted: 2016-09-13
Enrollment: 38
Sex: MALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SCREENING

Brief summary: The purpose of this study is to evaluate and compare the safety and pharmacokinetics of NVP-1402 and NVP-1402R in healthy male subjects.

Detailed description: This study is designed as randomized, open-label, active-controlled and crossover assignment for evaluate and compare the safety and pharmacokinetics of NVP-1402 and NVP-1402R in healthy male subjects. The safety assessed through adverse events up to 17 days after administration. Additional variables (ECGs, laboratory test, vital signs, so on) will also be recorded and assessed.

Eligibility criteria: Inclusion Criteria:

* Healthy males
* No history of clinically significant medical disorder
* Capable of consent to participate in the study

Exclusion Criteria:

* History of hypersensitive reactions to study drug or other related drugs
* Any significant abnormality found during screening
* Any significant medical history
* History of alcohol abuse, smoking continuously
* History of drug abuse
* Clinically significant surgery within 4 weeks prior to administration of the study drug
* Participation in another clinical trial within 3 months prior to administration of the study drug

Primary outcomes:
measure: Pharmacokinetics of plasma: Cmax
timeFrame: up to 24 hours after administration
measure: Pharmacokinetics of plasma: AUClast
timeFrame: up to 24 hours after administration
Secondary outcomes:
measure: Pharmacokinetics of plasma: AUCinf
timeFrame: up to 24 hours after administration
measure: Pharmacokinetics of plasma: Tmax
timeFrame: up to 24 hours after administration
measure: Pharmacokinetics of plasma: t1/2
timeFrame: up to 24 hours after administration
Other outcomes:
Locations:
city: Suwon-si
country: Korea, Republic of
facility: Navipharm
state: Gyeonggi-do
Study officials:
affiliation: Kyungpook National University Hospital
name: Young-Ran Yoon, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01173926: Comparison of the Effect of NN5401 With the Effect of NN1250 and Insulin Aspart in Subjects With Type 1 Diabetes
Official title: A Trial Comparing the Pharmacokinetic and Pharmacodynamic Properties Between NN5401 and NN1250 and Between NN5401 and Insulin Aspart in Subjects With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 1
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2010-08-02
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this trial is to compare the blood glucose-lowering effect of NN5401 (insulin degludec/insulin aspart, IDegAsp) with NN1250 (insulin degludec, IDeg) and insulin aspart (IAsp) in subjects with type 1 diabetes mellitus.


Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months.
* Body mass index 18.0-28.0 kg/m\^2 (both inclusive)

Exclusion Criteria:

* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
* Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day).
* Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period

Primary outcomes:
measure: Area under the glucose infusion rate curve
timeFrame: From 0 to 6 hours after single-dose (only for IDeg and IDegAsp)
measure: Area under the glucose infusion rate curve
timeFrame: From 6 to 24 hours after single-dose (only for IDegAsp and IAsp)
Secondary outcomes:
measure: Area under the serum insulin degludec concentration-time curve
timeFrame: From 0 to 120 hours after single-dose (only for IDeg and IDegAsp)
measure: Area under the serum insulin aspart concentration-time curve
timeFrame: From 0 to 12 hours after single-dose (only for IDegAsp and IAsp)
Other outcomes:
Locations:
city: Neuss
country: Germany
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT03714126: Remote Speech Analysis in HF Patients Undergoing Haemodialysis
Official title: A Non-Intervantional Study to Create a Patient Recordings and Clinical Database Using the Cordio System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Lead sponsor: Cordio Medical
Sponsor class: INDUSTRY
First posted: 2018-10-22
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acute and Chronic Congestive Heart Failure patients, undergoing hemodialysis in order to balance their volume overload.

Brief summary: This is an observational, non-interventional, prospective, single-arm, open study for database establishment for R\&D purposes. The study will be conducted in 1 site in Israel with up to fifty (50) patients. Patients under hemodialysis supervision will be enrolled in the clinical trial. Clinical information for the study will be collected at the hospital and at home. The patient will conduct recordings at home every day.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing hemodialysis every 5-10 days in order to balance their volume overload.
* Class C Heart Failure patient with reduced EF CHF (EF\<40%) and NYHA 2-3.
* Patients with dyspnea clinically related to pulmonary congestion
* Patient with more than 3 months HF disease duration.
* The patient is willing to participate as evidenced by signing the written informed consent.
* Male or non-pregnant female patient

Exclusion Criteria:

* Subject who, in the Investigator's opinion, unable to comply with the daily use of the App due to mental disorders (e.g., depression, dementia).
* Patient who has had a major cardiovascular event (e.g., myocardial infraction, stroke) within 3 months prior to screening visit.
* Patients likely to undergo heart transplantation/ LVAD within 6 months of Screening Visit or baseline functional capacity of NYHA 4.
* Patients with evidence of active Infection.
* Patient with severe alcohol or drug use.
* Psychological instability, inappropriate attitude or motivation.
* Patient with life threatening debilitating disease other than cardiac.
* Subject currently enrolled in another investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints.

Primary outcomes:
measure: Number of CHF patients with and without acute lung accumulation. in R&D Database
timeFrame: throughout study, upto 60 days per patient
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
Study officials:
affiliation: Hadassah Ein Kerem
name: Ittamar Gork, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03906357: Expanded Access of Pemigatinib to Treat a Single Patient With Metastatic Pancreatic Cancer
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
Collaborators: name: H. Lee Moffitt Cancer Center and Research Institute
First posted: 2019-04-08
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: Expanded access of Pemigatinib to treat a single patient with metastatic pancreatic cancer.


Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Dae Won Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01370057: The Use of Thoraco-lumbo-sacral Orthoses (TLSOs) in the Treatment of Adolescent Idiopathic Scoliosis (AIS)
Official title: The Use of TLSOs in the Treatment of Adolescent Idiopathic Scoliosis: A Prospective, Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Scoliosis
Keywords: Adolescent Idiopathic Scoliosis
Scoliosis
AIS
Brace
TLSO
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2011-06-09
Enrollment: 2
Sex: ALL
Minimum age (years): 10
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the risk of curve progression in Adolescent Idiopathic Scoliosis for subjects treated with bracing as compared to those without bracing.


Eligibility criteria: Inclusion Criteria:

* Confirmed Diagnosis of AIS
* Age ≥10, ≤15 years old
* Risser 0, 1 or 2
* Primary Cobb angle between 20 and 40 degrees (inclusive)
* Apex (of at least one of the primary curves) caudal to T7
* Pre-menarchal OR post-menarchal by ≤1 year
* Physical and mental ability to adhere to bracing protocol

Exclusion Criteria:

* Diagnosis of other musculoskeletal or developmental illnesses possibly responsible for the curvature
* A history of previous surgical or orthotic treatment
* Inability to read and understand Chinese

Primary outcomes:
measure: Curve progression
timeFrame: Till cessation of growth or progression of curve severity to 50 degrees or more, patient will be followed once every 6 months, an average follow up of 3 years is expected
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Prince of Wales Hospital
Study officials:
References:
Clinical trial NCT06692257: Orofacial Functions in Individuals With and Without Molar Incisor Hypomineralization
Official title: Orofacial Functions With Emphasis on Breathing and Chewing Patterns in Individuals With and Without Molar Incisor Hypomineralization: Observational Study Protocol
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Molar Hypomineralization, Incisor
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2024-11-18
Enrollment: 56
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The study will be conducted with children 6 to 12 years of age enrolled at the pediatric dentistry clinic of Nove de Julho University. The participants will be assessed in a single session during a visit to the clinic. All assessments will be performed by the same researcher.

Brief summary: Molar incisor hypomineralization (MIH) is a qualitative developmental defect of the enamel with a complex, multifactorial nature and a significant genetic component that predominantly affects the permanent first molars and, occasionally, the permanent incisors. Individuals with MIH have a compromised stomatognathic system manifested by muscle hyperactivity under postural and dynamic conditions. However, there is a gap in knowledge on the specific functional abnormalities that these individuals experience. Early identification and intervention, with a focus on the prevention of orofacial dysfunctions and deviations in facial growth and development, are aspects of the utmost importance. Therefore, the aim of the proposed study is to perform a comparative analysis of orofacial functions with an emphasis on breathing and chewing patterns in individuals with and without MIH. Methods and Analysis: Assessments will be performed using the Nordic Orofacial Test - Screening (NOT-S). Descriptive statistics will be performed and comparisons will be made using the chi-square test, adopting a 5% significance level.


Eligibility criteria: Inclusion Criteria:

* Children 6 to 12 years of age with a complete mixed dentition with all first molars present and in occlusion;
* Having all first molars erupted, without caries or previous treatment;
* Inclusion criteria for the MIH group: at least one permanent molar with indices compatible with MIH (code 2, 21, 22 and 3 - Ghanim criteria).

Exclusion Criteria:

* Children with amelogenesis and dentinogenesis imperfecta;
* Children undergoing orthodontic treatment;
* Children with a genetic syndrome;
* Children with the premature loss of deciduous teeth;
* Children with acute respiratory problems;
* Children in treatment.

Primary outcomes:
measure: Assessment of orofacial function (NOT-S) - (score from 0 to 12)
timeFrame: Baseline
Secondary outcomes:
measure: Assessment of hypersensitivity in teeth with MIH: Visual analog scale (VAS)
timeFrame: Baseline
measure: Schiff cold air sensitivity scale (SCASS)
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
References: