louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01377155: A Comparison of Two Initial Dosing Formulas
Official title: A Comparison of Two Initial Dosing Formulas for Basal Insulin in Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: basal insulin
hypoglycemia
diabetes mellitus type two
Lead sponsor: Diabetes Care Center
Sponsor class: INDUSTRY
First posted: 2011-06-21
Enrollment: 20
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 study will evaluate two methods of starting basal insulin to see which method may achieve a faster-to-goal titration.

Detailed description: The current recommended starting dose of basal insulin in type 2 diabetes is either a fixed dose, e.g. 10 U, or a weight-based formulas, 0.1-0.2 U/kg. The estimate of eventual titration dose to attempt to reach a fasting glucose goal is 0.49 U/kg. Those many weeks of dosage upward titration are required. The investigators propose to compare the current recommended weight based, 0.1 U/kg to a correction factor derived formula. Starting with an insulin tolerance test estimation of basal dose, one would arrive at the eventual titrated basal insulin dose in significantly less days than starting at a starting dose estimate of 0.1 U/kg. Further, there would be no significant increase in overall reported hypoglycemia.

Eligibility criteria: Inclusion Criteria:

1. Type 2 diabetes
2. Age 18 years and above
3. Concurrently on ± sulfonylureas ± thiazolidinedione ± DDP IV inhibitors ± metformin ± glinides
4. A1c ≥ 7.0% but ≤ 10%
5. Capable of self monitoring glucose ≥4/day
6. Previously compliant with clinical recommendations
7. Fasting blood glucose ≥ 150 mg/dl
8. BMI ≤ 45 kg/m2

Exclusion Criteria:

1. Urinary ketosis
2. Currently or expected alteration in insulin sensitivity such as major surgery, infection, renal failure (creatinine \>1.5 mg/dl), glucocorticoid treatment, recent (within 2 weeks) serious hypoglycaemic episode (requires assistant of another)
3. Currently participating in another clinical trial
4. Known or suspected allergy to insulin determir
5. Using insulin
6. Pregnancy or nursing or the intention of becoming pregnant or not using adequate
7. Significant liver or heart failure.

Primary outcomes:
measure: Days to reach the titration target
timeFrame: 12 weeks
Secondary outcomes:
measure: The frequency of reported and documented (<70 mg/dl) hypoglycemic events per 24 hour period
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Salinas
country: United States
facility: Diabetes Care Center
state: California
Study officials:
affiliation: Diabetes Care Center
name: Allen B King, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05784155: To Evaluate the PK, PD, Safety and Drug Tolerance of JW0302 in Healthy Volunteers
Official title: A Randomized, Open-label, Multiple-dose, Crossover Phase I Clinical Trial to Compare the Safety, Pharmacokinetics and Pharmacodynamics After Oral Administration of JW0302 to C2206 in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: JW Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2023-03-24
Enrollment: 44
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: A randomized, open, single-dose, 2x2 crossover-design clinical trial
Primary purpose: OTHER

Brief summary: 1. To evaluate the pharmacokinetic and pharmacodynamics characteristics after administration of Reference Drug or Test Drug in healthy volunteers under fasting conditions
2. To evaluate the safety and drug tolerance after administration of Reference Drug or Test Drug in healthy volunteers under fasting conditions


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

* Subjects does not meet the Inclusion Criteria

Primary outcomes:
measure: AUCτ, SS(Area under the plasma drug concentration-time curve within a dosing interval at steady state)
timeFrame: up to 24 hours
measure: Percent decrease from baseline in integrated gastric acidity for 24-hour interval after 7th dose
timeFrame: Baseline versus Multiple dose during 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Clinical Trial Center, Seoul National University Hospital
Study officials:
affiliation: Clinical Trial Center, Seoul National University Hospital
name: SeungHwan Lee, PI
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06168955: Study of N-homocysteinylation of Key Proteins in Alzheimer's Disease (HO-MA)
Official title: Study of N-homocysteinylation of Key Proteins in Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Alzheimer Disease
Keywords: Alzheimer Disease
Genetic
N-homocysteinylation
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2023-12-13
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

Brief summary: Alzheimer's disease (AD) is the leading cause of dementia in France. It is a multifactorial pathology, combining genetic and environmental risk factors. Homocysteine, a sulfur-containing amino acid belonging to the methionine-monocarbon cycle, has frequently been found at high levels in neurodegenerative diseases, and in AD in particular. It has been shown on human brain sections that the interaction of homocysteine with tau and MAP1, two key AD proteins, was significantly higher in AD patients than in controls, and corresponded to an N-homocysteinylation type interaction.

This is a prospective study, the main objective of which is to compare MAP1 N-homocysteinylation levels in fibroblasts from individuals with AD versus disease-free cell lines.


Eligibility criteria: Inclusion Criteria:

* age \> 18 years
* Age of onset of AD \< 75 years
* Person with AD with positive CSF biomarkers
* Person who has previously benefited from an analysis of AD genetic characteristics (APP, PSEN1, PSEN2, TREM2, ABCA7, SORL1 genes and ApoE status) and an analysis of monocarbon metabolism genes in the case of biochemical abnormalities by clinical exome, targeted panel or complete exome, and for whom the data set is already available.

Exclusion Criteria:

* Pregnant, parturient or breast-feeding women
* Minor (not emancipated)
* Person of legal age (subject to a legal protection measure)
* Adult unable to give consent

Primary outcomes:
measure: MAP1 homocysteinylation level
timeFrame: Baseline
Secondary outcomes:
measure: Homocysteinylation level of tau protein
timeFrame: baseline
Other outcomes:
Locations:
city: Nancy
country: France
facility: Centre Hospitalier Régional Universitaire de Nancy
Study officials:
affiliation: Central Hospital Nancy
name: Mathilde Renaud
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03559855: Evaluation of High School-based Relationship Education
Official title: Evaluation of High School-based Relationship Education: Center for Relationship Education
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Responsible Sex
Lead sponsor: University of Denver
Sponsor class: OTHER
First posted: 2018-06-18
Enrollment: 1135
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is a randomized controlled trial testing the effectiveness of a program provided in Colorado high schools by the Center for Relationship Education based in Denver, Colorado. 14 schools are randomly assigned to either provide the Real Essentials curriculum as part of health or similar classes or teach these classes as usual. The study design includes surveys administered pre-program, post-program and at 6-month and 12-month follow ups. Primary study outcomes are increased knowledge of healthy relationships and reduced risky sexual behavior.


Eligibility criteria: Inclusion Criteria:

* Must be enrolled in designated classes at 14 participating high schools schools in Colorado

Exclusion Criteria:

-

Primary outcomes:
measure: Healthy Relationship Knowledge and Skills
timeFrame: Change from pre-program through 1 year
measure: Risky Sexual Behavior
timeFrame: Change from pre-program through 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: University of Denver
state: Colorado
Study officials:
References:
Clinical trial NCT03897855: Memory Inhibition and Delayed Onset Post-traumatic Stress Disorder in Older Subjects
Official title: Memory Inhibition and Delayed Onset Post-traumatic Stress Disorder in Older Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-Traumatic Stress Disorder in Old Age
Lead sponsor: Centre Hospitalier de Niort
Sponsor class: OTHER
First posted: 2019-04-01
Enrollment: 20
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: In the elderly, we can see a post-traumatic syndrome associated with an event that occurred before old age that had not previously manifested or not fully manifested.

This little-known pathology and notable psychiatric co-morbidities (depression, anxiety) can take in elderly subjects different masks that interfere with diagnosis and treatment.

The data in the literature suggest that this Post-Traumatic Stress Disorder with Delayed Expression (TSPT-R) may be related to a deficiency of the executive functions of inhibition, and more particularly a deficit of mental memory inhibition and therefore the removal of unwanted memories.


Eligibility criteria: Inclusion Criteria:

-

Regarding the constitution of the group patient (TSPT-R):

* Subjects 65 years of age or older
* Clinical diagnosis of delayed-onset PTSD according to DSM-5 criteria after 65 years
* The traumatic event must have taken place at the latest before 65 years
* Affiliated person or beneficiary of a social security scheme.
* Written consent before any examination required by research)

Regarding the constitution of the control group:

* Subjects 65 years of age or older
* No diagnosis of PTSD (delayed or not) or history of PTSD (delayed or not)
* Affiliated person or beneficiary of a social security scheme.
* Written consent before any examination required by the research).

Exclusion Criteria:

* For both groups:
* Acute or chronic cognitive impairment known
* GRECO MMSE pathological score less than or equal to the pathological threshold weighted according to level of education and age, namely:

  * 22 if no diploma
  * 23 if certificate of study
  * 25 if patent
  * 26 if bin or more
  * Remove one point at each threshold if age\> 80 years
* Sensory or motor disorder preventing the passing of different tests
* Psychotic disorder
* Mood disorder in decompensation (for depression, HAD-D score equal to or greater than 11)
* Disorder of the use of a moderate or severe substance (except tobacco).
* Patients under guardianship or curatorship.

Primary outcomes:
measure: Inhibition score measured by the Think / No-Think Test
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Niort
country: France
facility: Centre Hospitalier de Niort
Study officials:
affiliation: Centre Hospitalier de Niort
name: Dominique LEGER, Doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02605655: Clinical Trial of Chinese Formula AMP-1915 on Metabolic Syndrome
Official title: Phase 0 Clinical Trial of Chinese Formula AMP-1915 on Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Metabolic Syndrome X
Keywords: obesity
hyperlipidemia
hyperglycemia
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2015-11-16
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
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 determine whether the Chinese formula AMP-1915 has effect on Metabolic Syndrome (MS) in MS patients. Half of patients received AMP-1915, while the other half received placebo.

Detailed description: In China, the herbal formulas have been used in the treatment of diabetes for centuries. Huangqisan, investigators named it AMP-1915, is one of traditional Chinese herbal formula used to relieve diabetes which was recorded in Shengji Zonglu (General Medical Collection of Royal Benevolence) published in 1117 A.D. AMP-1915 consists of three herbs: Radix Astragali (roots of Astragalus membranaceus (Fisch.) Bge. var. mongholicus (Bge.) Hsiao, A), Mori Cortex radices (root barks of Morus alba L., M) and Puerariae Lobatae Radix (roots of Pueraria lobata (Willd.) Ohwi., P). Recent studies have shown that these three herbs and their constituents have therapeutic effects on the metabolic disorders.

This randomized, double-blind, placebo-controlled trial was conducted in a community hospital of Shanghai, China. 60 adult participants were metabolic disorder patients according with at least two impaired metabolic profiles (obesity, hyperglycemia, hyperlipidemia or others). During 3-month treatment, participants were randomly divided in to two groups assigned to take AMP-1915 or placebo. AMP-1915 or placebo was mixed into instant noodles as daily meals with same color, shape, size and packaging. BMI, fasting blood glucose (FBG), triglyceride (TG), total cholesterol (TCH), high-density lipoprotein cholesterol (HDL-c), low-density lipoprotein cholesterol (LDL-c), insulin, HbA1c were measured before and after treatment.

Eligibility criteria: Inclusion Criteria:

* Overweight (BMI \>= 20) or
* Hyperglycemia (FBG\>=6.7 mmol/l) or
* Hyperlipidemia (TG \>=1.7 mmol/l or TCH\>=5.72 mmol/l or HDL-c \<=1.00 mmol/l or LDL-c\>=3.12 mmol/l)

Exclusion Criteria:

-

Primary outcomes:
measure: Fasting blood glucose (FBG)
timeFrame: Change from baseline FBG at 3 months
Secondary outcomes:
measure: Plasma lipid levels
timeFrame: Change from baseline lipid levels at 3 months
measure: Plasma Insulin concentration
timeFrame: Change from baseline insulin concentration at 3 months
measure: Body weight
timeFrame: Change from baseline body weight at 3 months
measure: Plasma HbA1c
timeFrame: Change from baseline Plasma HbA1c at 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Shanghai University of TCM
name: Guang Ji, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00932555: EffeKt Taiwan- Efficacy and Safety of Long-term Treatment With KOGENATE® FS in Taiwan
Official title: EffeKt Taiwan- Efficacy and Safety of Long-term Treatment With KOGENATE® FS in Taiwan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemophilia A
Keywords: Octocog alfa
Hemophilia A
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-07-03
Enrollment: 82
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of patients with a diagnosis of hemophilia A. Physicians should consult the full prescribing information for KOGENATE® FS before enrolling patients and familiarize themselves with the safety information in the product package label.

Brief summary: The aim of this international prospective post-marketing surveillance study is to obtain data on treatment procedures, long-term safety and efficacy and patient acceptance of KOGENATE Bayer/FS in treatment of patients with haemophilia A under daily-life treatment conditions.


Eligibility criteria: Inclusion Criteria:

* Patients with diagnosis of hemophilia A, independent of age, treated with KOGENATE FS as their only source of FVIII, decision taken by the investigator to administer KOGENATE FS. For pretreated patients with more than 100 exposure days an inhibitor assessment within three months prior to enrollment should be available; for pretreated patients with less than 100 exposure days an inhibitor assessment at baseline should be available.

Primary outcomes:
measure: Efficacy and Safety of Kogenate FS
timeFrame: After 12 months and after 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Many Locations
country: Taiwan
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00714155: Outcomes and Patient Satisfaction After Colpocleisis for Pelvic Organ Prolapse
Official title: Outcomes and Patient Satisfaction After Colpocleisis for Pelvic Organ Prolapse
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Organ Prolapse
Keywords: Colpocleisis
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2008-07-14
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Urogynecology clinic

Brief summary: The purpose of this study is to evaluate the long-term success rate of the colpocleisis procedure and its effect on quality of life in women who have this surgery. We want to see if women who have this surgery have problems with recurrent pelvic organ prolapse, urinary incontinence, or bowel problems after the surgery. We also want to see how the surgery affects women's sexuality.


Eligibility criteria: Inclusion Criteria:

* women who underwent either total colpectomy with colpocleisis or partial colpectomy with LeFort-type colpocleisis performed by the Urogynecology service between 1/2000 and 12/2007 at Strong Memorial Hospital

Exclusion Criteria:

* women who are not undergone colpocleisis or colpectomy

Primary outcomes:
measure: Questionnaires
timeFrame: Post-operative
Secondary outcomes:
measure: Physical Examination
timeFrame: Post-operative
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: Erin E. Duecy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02084355: Study of Opioid Rotation Versus Opioid Escalation in Patients With Moderate to Severe Cancer Pain
Official title: Efficacy and Safety of Opioid Rotation Compared With Opioid Dose Escalation in Patients With Moderate to Severe Cancer Pain - Open Label, Randomized, Prospective Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Cancer
Pain
Keywords: Significant cancer pain
at least numeric rating scale 4
Lead sponsor: Gyeongsang National University Hospital
Sponsor class: OTHER
First posted: 2014-03-12
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Although opioid rotation is well known treatment modality in reducing pain and opioid-induced neurotoxicity, it is not established whether opioid rotation is more appropriate or opioid escalation is more effective in controlling significant pain in cancer patients under opioid medication.

- The purpose of this study is to determine effective therapy out of opioid rotation and opioid dose escalation in patients with moderate to severe cancer pain who have been already treated with strong opioid.


Eligibility criteria: Inclusion Criteria:

* age \> 18 years
* patients who are being treated with one of strong opioids including oral oxycodone, oral hydromorphone, or fentanyl patch with range from 60 mg to 200 mg of oral morphine equivalent daily dose (MEDD)
* moderate to severe cancer pain (numeric rating scale more than 3) at screening
* patients without uncontrolled adverse effects associated with currently applied opioid

Exclusion Criteria:

* previous opioid rotation
* unable to take oral medication
* life expectancy less than a month
* newly started chemotherapy and/or radiotherapy within past 2 weeks of screening
* serum aspartate aminotransferase, alanine aminotransferase, or alkaline phosphatase \> 2.5 times of upper normal limit
* serum total bilirubin or creatinine \> 1.5 times of upper normal limit

Primary outcomes:
measure: The rate of successful pain control defined as a 30% or 2-point reduction in the numeric rating scale
timeFrame: Eighteen months
Secondary outcomes:
Other outcomes:
Locations:
city: Jinju
country: Korea, Republic of
facility: Gyeongsang National University Hospital
state: Gyeongsangnam-do
Study officials:
References:
Clinical trial NCT04703855: Hong Kong and Taiwan HM3 PMS
Official title: Post Market Surveillance of the HeartMate 3 Left Ventricular Assist System in Hong Kong and Taiwan
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Advanced Heart Failure
Keywords: HeartMate 3
Left ventricular assist device
ABT-CIP-10382
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2021-01-11
Enrollment: 3
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: Hong Kong and Taiwan HM3 PMS is a prospective, single arm, post market surveillance is designed to evaluate clinical and functional outcomes with the HM3 LVAS as a treatment for advanced heart failure. The PMS will enroll approximately 30 patients, that meet the HM3 commercially approved labelling indications, from approximately 4 sites in Hong Kong and Taiwan. PMS participants will be followed until the 24 months follow-up visit or until they experience an outcome, whichever comes first.


Eligibility criteria: Inclusion Criteria:

- All patients at the participating sites that are determined to meet the HM3 commercially approved labelling indication and have a planned HM3 implant are eligible to participate in this PMS. Assessment for eligibility criteria is based on medical records of the site and interview with a candidate patient.

Exclusion Criteria: None

Primary outcomes:
measure: Primary Efficacy Endpoint: Number of Participants With Overall Survival to Transplant, Myocardial Recovery or on Device Support Free of Debilitating Stroke (Modified Rankin Score >3) or Reoperation for Pump Replacement
timeFrame: Up to 6 months follow-up
measure: Primary Safety Endpoint: Number of Cumulative Occurrence of Adverse Events
timeFrame: Up to 6 months follow-up
Secondary outcomes:
measure: Mean Change in Six-minute Walk Test From Baseline
timeFrame: Baseline and 1 Month post-implant
measure: Change Proportion of New York Heart Association (NYHA) Functional Status From Baseline
timeFrame: Baseline and 1 Month post-implant
measure: Mean Change in EQ-5D-5L VAS Quality of Life (QoL) From Baseline
timeFrame: Baseline and 1 Month
measure: Frequency of Rehospitalization and Reoperation
timeFrame: Up to 6 months follow-up
measure: Number of Participants With Device Malfunctions
timeFrame: Up to 6 months follow-up
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: University of Hong Kong
state: Pokfulam
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei City
country: Taiwan
facility: Tri-Service General Hospital
Study officials:
affiliation: Abbott Medical Devices
name: Carlo Gazzola, B. Sc.
role: STUDY_DIRECTOR
References: