louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00349427: A Study Of Rosiglitazone Plus Insulin To Treat Type 2 Diabetes Mellitus Patients
Official title: A Randomized, Double-Blind, Placebo-Control, Clinical Evaluation of Insulin Plus Rosiglitazone Compared to Insulin Plus Placebo for 24 Weeks in Subjects With Type 2 Diabetes Mellitus Who Are Inadequately Controlled On Insulin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Diabetes Mellitus, Type 2
Keywords: Insulin
BRL49653 /rosiglitazone
Type 2 Diabetes Mellitus
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-07-07
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to demonstrate that addition of rosiglitazone (4mg) to insulin in Type 2 diabetes mellitus subjects who have not achieved glycemic goals on insulin injections alone is efficacious in terms of improving glycemic control.


Eligibility criteria: Inclusion:

* Patients with type 2 Diabetes mellitus on a minimum dose of 30 units/day insulin monotherapy continuously for at least 8 weeks
* If Patients are taking another oral antidiabetic agent may stop their oral agent and adjust their insulin dose properly over 8 weeks prior to screening if they are asked by doctor who considers him/her suitable for study in all other respects, and the HbA1c level\>7.5%.

Exclusion:

* Fasting plasma glucose \>13 mmol/L at screening
* Ongoing edema or history of peripheral edema requiring pharmacological treatment within 12 months
* Drug abuse
* Women pregnant or lactating
* Use any rosiglitazone like drug in 3 months
* Use more than one oral antidiabetic agent in 2 months
* Uncontrolled hypertension
* Chronic heart failure
* Anemia

Primary outcomes:
measure: glycemic control at treatment 24-week measured by HbA1c (Glycosylated hemoglobin)
timeFrame: 24 weeks
Secondary outcomes:
measure: glycemic control at treatment 24-week measured by fasting plasma glucose and daily insulin dose, proportion of subjects who reduce total daily insulin dose after treatment of 8, 16, and 24 weeks
timeFrame: 8, 16, and 24 weeks
Other outcomes:
Locations:
city: Nanjing
country: China
facility: GSK Investigational Site
state: Jiangsu
city: Xian
country: China
facility: GSK Investigational Site
state: Shanxi
city: Beijing
country: China
facility: GSK Investigational Site
city: Beijing
country: China
facility: GSK Investigational Site
city: Beijing
country: China
facility: GSK Investigational Site
city: Beijing
country: China
facility: GSK Investigational Site
city: Shanghai
country: China
facility: GSK Investigational Site
city: Shanghai
country: China
facility: GSK Investigational Site
city: Shanghai
country: China
facility: GSK Investigational Site
city: Tianjin
country: China
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT05750927: Aortic Stenosis With COmplex PCI (ASCOP) Features Retrospective Registry on Contemporary Management and Outcomes
Official title: Aortic Stenosis With COmplex PCI (ASCOP) Features Retrospective Registry on Contemporary Management and Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Valve Stenosis
Transcatheter Aortic Valve Replacement
Angioplasty, Balloon, Coronary
Coronary Artery Disease
Lead sponsor: Niguarda Hospital
Sponsor class: OTHER
First posted: 2023-03-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Severe, symptomatic aortic stenosis with an indication to TAVI 2. Concomitant, stable CAD with an indication to complex PCI, as anticipated by angiography, defined as follows (one or more features)

Brief summary: To describe the prevalence and clinical features of patients with severe aortic stenosis undergoing TAVI and concomitant clinically indicated, complex and/or high-risk PCI

Detailed description: The aims of this study are:

* to describe the prevalence and clinical features of patients with severe aortic stenosis undergoing TAVI and concomitant clinically indicated, complex and/or high-risk PCI
* to depict the different possible strategies that are currently employed in this context and to retrospectively analyze outcomes
* to investigate predictors of better outcomes

Eligibility criteria: 1. Severe, symptomatic aortic stenosis with an indication to TAVI
2. Concomitant, stable CAD with an indication to complex PCI, as anticipated by angiography, defined as follows (one or more features)

   1. Left-main (LM) CAD or proximal left anterior descending (LAD) / left circumflex (LCx) lesions requiring LM-PCI
   2. Three-vessel disease
   3. Last remaining vessel
   4. Bifurcation PCI (proximal bifurcation)
   5. Severely calcified lesions requiring calcium plaque modification (rotational/orbital atherectomy, intravascular lithotripsy, scoring or cutting balloon)
   6. Lesion length \> 30 mm
   7. Severely depressed Left ventricular function requiring mechanical circulatory support (intra-aortic balloon pump - IABP, Impella, Extracorporeal Membrane Oxygenation - ECMO

Primary outcomes:
measure: POCE
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: ASST GOM Niguarda
Study officials:
References:
Clinical trial NCT04998227: Latent TGF-β-binding Proteins Affect the Fibrotic Process in Renal Impairment and Cardiac Dysfunction
Official title: Latent TGF-β-binding Proteins Affect the Fibrotic Process in Renal Impairment and Cardiac Dysfunction
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Coronary Syndrome
Acute Coronary Syndrome With Renal Dysfunction
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2021-08-10
Enrollment: 300
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects between 20-80 yrs, with acute coronary syndrome in NTUH.

Brief summary: The project is planed to explore the impact of LTBP4 and other matrix protein and potentially related biomarkers on renal outcomes, cardiac outcomes and all-cause mortality in patients with suspected acute coronary syndrome (ACS).

Detailed description: The investigators will collect the blood samples from patients with suspect ACS. LTBP4 will be the first matrix protein that are going to understand. Upon hospital arrival, blood samples around 8 ml will be collected and the 2nd collection will be two weeks to one month after the event. The third collection will be one year later. In the between, if any ACS event develop, blood samples will be collected as protocols.

Eligibility criteria: Inclusion Criteria:

- acute coronary syndrome patients

Exclusion Criteria:

- cardiogenic shock, pregnancy, end-stage renal disease

Primary outcomes:
measure: Change of renal functions
timeFrame: One month, Six month and one year
measure: All cause mortality
timeFrame: 3 years
measure: Incidence of hospitalization
timeFrame: 3 years
measure: Incidence of required myocardial revascularization
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References:
Clinical trial NCT05072327: Mohs Surgery Combind With Cryotherapy for Eyelid Malignant Tumors.
Official title: Mohs Surgery Combind With Cryotherapy for Eyelid Malignant Tumors: a Prospective Randomized Controlled Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Eyelid Tumor
Keywords: Eyelid Tumor
Basal Cell Carcinoma
Squamous Cell Carcinoma
Sebaceous Carcinoma
Mohs surgery
cryotherapy
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2021-10-08
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aim to investigate whether the prognosis of eyelid malignant tumor is better treated with Mohs surgery combind with cryotherapy than Mohs surgery only.

Detailed description: This study is a randomized perspective study. American Joint Committee on Cancer was applied to define the cancer stage of patients recruited. Patients with Tis to T3cN0M0 will be randomized to receive Mohs surgery or Mohs suregery conbind cryotherapy. Patients will be followed for 3 years.

Eligibility criteria: Inclusion Criteria:

* Ability to provide written informed consent and comply with study assessments for the full duration of this study.
* Definite pathology signs of eyelid basal cell carcinoma, squamous cell carcinoma and sebacous carcinoma, Stage Tis to T3CN0M0 based on American Joint Committee on Cancer.
* Pathological examination showed the primary tumor was compeletely resected

Exclusion Criteria:

* Any previous treatment in the study eye
* Tumor complicated with infection
* Any other tumors of the paticipants
* Intolerate of surgery or anesthesia

Primary outcomes:
measure: recurrence rate of tumor
timeFrame: three years
measure: progression rate of tumor
timeFrame: three years
Secondary outcomes:
measure: all cause mortailty
timeFrame: three years
measure: side effects of Mohs surgery and cryotherapy in the treatment of eyelid malignant tumor
timeFrame: three years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Huasheng Yang, Doctor
role: STUDY_CHAIR
References:
Clinical trial NCT00184327: Changes Following Inpatient Child-oriented Family Treatment
Official title: Change Across Intensive Inpatient Family Treatment in Child and Adolescent Psychiatry. A Multi-site Study of Parents and Children in Inpatient Family Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psychiatric Disorders
Keywords: Severe and longstanding psychiatric symptoms in children
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Haukeland University Hospital
name: St. Olavs Hospital
name: Helse Nord-Trøndelag HF
name: Namsos Hospital
First posted: 2005-09-16
Enrollment: 150
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Family offered inpatient family treatment in child and adolescent psychiatry

Brief summary: Children receiving IFT (intensive family therapy) were assessed for symptom profile and global functioning before admission, 3 months after discharge and 1 year after discharge. Children were assessed by parents, children, their teachers and themselves. Parents were assessed by themselves at the same points in time through psychological self-report questionnaires.

The study is intended to explore covariates to change in children as well as in parents during (pre-treatment) the treatment and follow-up periods.

Detailed description: IFT is an intensive combinatory family treatment which is child-oriented, and traditionally used in an inpatient family treatment unit in child and adolescent psychiatry.

Measures include ones on bonding (PBI), personality traits (NEO-PI), anxiety and depressive symptoms (HADS), attributional tendencies (PAT) and social desirable responding (BIDR). A subgroup was also assessed before a waiting period (pre-treatment).

Eligibility criteria: Inclusion Criteria:

* Family offered inpatient family treatment in child and adolescent psychiatry.

Exclusion criteria

* inpatient treatment terminated prematurely

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital, Helse Bergen
city: Levanger
country: Norway
facility: Levanger Hospital
city: Namsos
country: Norway
facility: Namsos Hospital
city: Trondheim
country: Norway
facility: Norwegian University of Science and Technology (NTNU), Faculty of Medicine, Dept. of Neuroscience, Center for Child and Adolescent Mental Health
city: Trondheim
country: Norway
facility: St.Olav Hospital
Study officials:
affiliation: Norwegian University of Science and Technology (NTNU), Faculty of Medicine, Dept. of Neuroscience, Center for Child and Adolescent Mental Health
name: Tormod Rimehaug, Asst. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rimehaug T, Berg-Nielsen TS, Wallander J. Change in self-reported emotional distress and parenting among parents referred to inpatient child psychiatric family treatment. Nord J Psychiatry. 2012 Sep;66(4):260-7. doi: 10.3109/08039488.2011.630752. Epub 2011 Nov 16.
Clinical trial NCT06053827: Natural Frozen Embryo Transfer (FET) vs Substituted Frozen Embryo Transfer (FET)
Official title: Embryo Transfer in Natural vs Substituted Cycle and the Scheduling Pattern of IVF
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Fertility Disorders
Lead sponsor: Clinique Ovo
Sponsor class: INDUSTRY
First posted: 2023-09-26
Enrollment: 500
Sex: FEMALE
Maximum age (years): 40
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Data spreadsheet from Jan 2022 to March 2023 of patients undergoing natural or substituted frozen embryo transfer

Brief summary: In frozen embryo transfer substituted cycles, patients are treated with progesterone and estrogen in an attempt to mimic the natural cycle and a transfer is planned whenever the endometrium is ready. In contrast, in frozen embryo transfer natural cycle patients are not taking any hormones, only triggered with hCG (human chorionic gonadotropin) when a dominant follicle is ready or they wait for the disappearance of the dominant follicle to plan the transfer date. Some doctors and centres shift towards using the substituted protocol in an attempt to make scheduling easier with less frequent ultrasounds.

This study will aim to compare clinical and biochemical pregnancy rates in patients who underwent frozen embryo transfers in natural cycles vs substituted cycles at the centre.


Eligibility criteria: Inclusion Criteria:

* Age \< 40 years old
* Women having undergone either a frozen embryo transfer in natural cycle or substituted cycle
* IVF and FET cycles done at Clinique OVO

Exclusion Criteria:

* egg or embryo recipient
* History of recurrent miscarriages, defined as ≥ 3 consecutive losses
* Patients that needed Viagra, Plasma-Rich Platelet (PRP) or other modalities to improve their endometrial thickness
* Uterine abnormalities
* Abnormal hormonal profiles
* FET Stimulated cycles
* History of recurrent implantation failure defined as failed ≥ 2 euploid embryos transfer or ≥ 3 blastocysts

Primary outcomes:
measure: Evaluate the clinical pregnancy rate of embryo transfer in natural vs substituted cycles
timeFrame: 6 to 8 weeks after Frozen Embryo Transfer
Secondary outcomes:
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Clinique Ovo
state: Quebec
Study officials:
affiliation: clinique ovo R&D department
name: Camille Sylvestre, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02864927: Postmarketing Surveillance Study for Use of Menactra® in the Republic of Korea
Official title: Postmarketing Surveillance Study for Use of Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®) in the Republic of Korea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Meningitis
Meningococcal Meningitis
Meningococcal Infections
Keywords: Meningitis
Meningococcal Meningitis
Meningococcal Infections
Menactra®
Meningococcal Vaccine
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2016-08-12
Enrollment: 1311
Sex: ALL
Minimum age (years): 9
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to perform the re-examination of Menactra® administered in the routine clinical settings in accordance with the Ministry of Food and Drug Safety regulation.

Primary objective:

* To describe the safety profile after 1 dose of Menactra® administered from 9 months to 55 years of age under standard health care practice.

Detailed description: Subjects aged 9 months through 55 years and who are given study vaccine during routine health-care visits will be enrolled in the study.

They will be followed-up for up to Day 42 following vaccination.

No study vaccine will be supplied or administered as part of this study, subjects will be monitored following routine vaccine administration in clinical settings.

Eligibility criteria: Inclusion Criteria:

* Informed consent form signed by the subject (for subjects from 19 to 55 years of age) or the parent(s) or other legal representative (for subjects from 9 months to 18 years of age)
* Receipt of one dose of Menactra® (on the day of inclusion) according to approved local product insert paper .

Exclusion Criteria:

* Participation at the time of study enrollment (or in the 4 weeks preceding the study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or a medical procedure
* Subjects who already participated in this study.

Primary outcomes:
measure: Number of Participants Reporting Solicited Injection-Site Reactions and Systemic Reactions Following Vaccination with Menactra®
timeFrame: Day 0 up to Day 30 post-vaccination
measure: Number of Participants Reporting Unsolicited Adverse Events Following Vaccination with Menactra®
timeFrame: Day 0 up to Day 30 post-vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
Study officials:
affiliation: Sanofi Pasteur, a Sanofi Company
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: Kim HS, Engel S, Neveu D, Thollot Y, Oster P, Yang K. Post-Marketing Surveillance Observational Study of Quadrivalent Meningococcal Diphtheria Toxoid Conjugate Vaccine (MenACWY-DT, MCV4/Menactra(R)) in the Republic of Korea, 2014-2019. Infect Dis Ther. 2021 Mar;10(1):399-409. doi: 10.1007/s40121-020-00393-4. Epub 2021 Jan 13.
Clinical trial NCT00699127: Organizing the Information Given to Parents of NICU Infants in Order to Reduce Their Anxiety
Official title: Dose Organizing the Information Given to Parents of NICU Infants Reduce Their Anxiety?
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Anxiety
Keywords: anxiety
parents
NICU
prematurity
Anxiety of parents to NICU infants
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2008-06-17
Enrollment: 0
Sex: ALL
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Being a parent to a premature infant in NICU is an anxious state. Parents ask a lot of questions, and look for information all the time. Organizing the information given to parents could reduce their anxiety. The parents will be divided into two groups: one group will get organized information, by a lecture at the first week of their infant's life, and the other group will not. Of course, questions will be answered all the time. The parents will answer a questionnaire on the first week of the infant's life, and on the last week, just before releasing the infant home.

Detailed description: Being a parent to a premature infant in NICU is an anxious state. Parents ask a lot of questions, and look for information all the time. Organizing the information given to parents could reduce their anxiety. The parents will be divided into two groups: one group will get organized information, by a lecture at the first week of their infant's life, and the other group will not. Of course, questions will be answered all the time. The parents will answer a questionnaire on the first week of the infant's life, and on the last week, just before releasing the infant home.

Eligibility criteria: Inclusion Criteria:

* Parents to premature infants, after releasing the mother

Exclusion Criteria:

* Term infants
* Hospitalized mother

Primary outcomes:
measure: Difference between questionnaires at the first week and the last week to hospitalization.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe medical center
Study officials:
affiliation: Hillel Yaffe medical center, Hadera, Israel
name: Erez Nadir, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03732027: Anterior Abdominal Blocks for Postoperative Pain Control in Obese Patients
Official title: Anterior Abdominal Blocks for Postoperative Pain Control in Obese Patients Undergoing Major Gynecological Surgery: Surgical Transversus Abdominis Plane Block Versus Surgical Rectus Sheath Block
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2018-11-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare between two surgical techniques for anterior abdominal wall blocks in obese patients Undergoing Major Gynecological Surgery: Surgical Transversus Abdominis Plane \[TAP\] block versus Rectus Sheath block as regards the efficacy and adverse effects


Eligibility criteria: Inclusion Criteria:

* female patients
* undergoing major gynecological surgery with supraumbilical midline incision the first time
* Body mass index (BMI) more than 40.

Exclusion Criteria:

* patient refusal to participate in the study,
* reoperation,
* addiction
* alcohol abuse
* hypersensitivity or allergy to the study drugs

Primary outcomes:
measure: Total dose of morphine consumption
timeFrame: First 24 hours postoperatively
Secondary outcomes:
measure: Numerical rate scale
timeFrame: First 24 hours postoperatively
measure: Postoperative respiratory functions
timeFrame: First 24 hours postoperatively
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University hospitals
Study officials:
affiliation: Faculty of Medicine,Ain Shams University
name: Marwa AK Elbeialy, MD
role: PRINCIPAL_INVESTIGATOR
References: