louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00541697: Eze/Simva Switch Study in Diabetics (0653A-807)
Official title: A Double-Blind, Multicenter Study to Assess the LDL-C Lowering of Combination Tablets Ezetimibe/Simvastatin (10mg/20mg) and Ezetimibe/Simvastatin (10mg/40mg) Compared to Atorvastatin 20mg in Patients With Type II Diabetes.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2007-10-10
Enrollment: 648
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: A study to assess the effectiveness and tolerability of MK0653A and MK0653A versus Atorvastatin in lowering LDL-C levels.


Eligibility criteria: Inclusion Criteria:

* Currently being treated with Atorvastatin 10 mg for at least 6 weeks
* Have Type 2 Diabetes
* Weight must be stable for more than 6 weeks before entering the study

Exclusion Criteria:

* Consume more than 14 alcoholic drinks per week.
* Pregnant or lactating
* Have taken another investigation drug within 3 months of starting this study
* History of congestive heart failure, heart attack, coronary artery bypass surgery
* Uncontrolled high blood pressure
* HIV positive
* History of cancer in the last 5 years

Primary outcomes:
measure: Determine the additional LDL-C lowering achieved by switching to MK0653A as compared to Atorvastatin after 6 weeks of treatment
timeFrame: 6 Weeks
Secondary outcomes:
measure: Determine the effect of MK0653A versus Atorvastatin on total cholesterol after 6 weeks of treatment
timeFrame: 6 Weeks
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Constance C, Westphal S, Chung N, Lund M, McCrary Sisk C, Johnson-Levonas AO, Massaad R, Allen C. Efficacy of ezetimibe/simvastatin 10/20 and 10/40 mg compared with atorvastatin 20 mg in patients with type 2 diabetes mellitus. Diabetes Obes Metab. 2007 Jul;9(4):575-84. doi: 10.1111/j.1463-1326.2007.00725.x. Epub 2007 Apr 19.
Clinical trial NCT00949897: Comparison Study of Biofoam Porous Metal Versus Allograft to Treat Adult Acquired Flatfoot
Official title: A Randomized, Prospective, Controlled Trial for Lateral Column Lengthening in Adult Acquired Flatfoot Using Biofoam Porous Metal Compared With Allograft
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Adult Acquired Flatfoot
Keywords: Adult Acquired Flatfoot
Biofoam Porous Metal Implant
Allograft Bone Wedge
Lead sponsor: OrthoCarolina Research Institute, Inc.
Sponsor class: OTHER
Collaborators: name: Stryker Trauma and Extremities
First posted: 2009-07-31
Enrollment: 0
Sex: ALL
Minimum age (years): 25
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 is to compare the clinical and radiographic outcomes of a randomized, consecutive series of adult patients, with an acquired flatfoot, treated with a lateral column lengthening using an allograft bone wedge versus a titanium porous metal implant (Biofoam, Wright Medical).

Null hypothesis: At six months postoperatively, there is no difference in the degree of correction as measured by the talonavicular coverage angle between patients randomized to allograft and Biofoam.

Alternative hypothesis: At six months postoperatively, the degree of correction as measured by the talonavicular coverage angle will be less in patients randomized to allograft than the degree of correction in patients randomized to Biofoam.


Eligibility criteria: Inclusion Criteria:

* Ages 25-75
* Unresponsive to conservative treatment
* Patient with acquired flatfoot deformity, who is a candidate for lateral column lengthening (Stage IIB) = (greater than \> 40% uncoverage of talar head by navicular on standing AP radiograph)

Exclusion Criteria:

* Less than 25 years of age and greater than 75 years
* Pre-existing infection
* Peripheral neuropathy
* Charcot arthropathy
* Peripheral vascular disease
* Rhematoid Arthritis (RA) or inflammatory arthropathy
* Metal allergy or sensitivity to metal

Primary outcomes:
measure: The degree of correction as measured by talonavicular coverage angle, which is used to quantify the degree of deformity. Degree of correction is defined as the difference between the preoperative and postoperative talonavicular coverage angle.
timeFrame: 2 weeks, 6 weeks, 12 weeks, and 6 months
Secondary outcomes:
measure: American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Score
timeFrame: 2 weeks, 6 weeks, 3 months, and 6 months
measure: Foot Function Index (FFI) Score
timeFrame: 2 weeks, 6 weeks, 3 months, and 6 months
measure: Pain Visual Analog Scale (VAS)
timeFrame: 2 weeks, 6 weeks, 3 months, and 6 months
measure: Implant failure
timeFrame: 2 weeks, 6 weeks, 3 months, and 6 months
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: OrthoCarolina, P.A.
state: North Carolina
Study officials:
affiliation: OrthoCarolina, P.A.
name: Robert B Anderson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06122597: A Clinical Trial to Evaluate the Efficacy of ConcenTrace to Buffer pH Levels Within the Body.
Official title: A Clinical Trial to Evaluate the Efficacy of ConcenTrace to Buffer pH Levels Within the Body.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: pH
Lead sponsor: Trace Minerals
Sponsor class: INDUSTRY
Collaborators: name: Citruslabs
First posted: 2023-11-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This virtual single-arm trial will last 12 weeks. Participants will take the drops daily and complete questionnaires at Baseline, Week 4, Week 8, and Week 12.

Urine pH measurements will be taken at Baseline, Week 4, Week 8, and Week 12 using pH test strips.


Eligibility criteria: Inclusion Criteria:

* Male or female. Aged 18+. Generally healthy - don't live with any uncontrolled disease. Willing to maintain their standard dietary pattern, activity level, and body weight for the duration of the study.

Exclusion Criteria:

* Anyone with a pre-existing chronic condition that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders.

Anyone with known severe allergic reactions. Women who are pregnant, breastfeeding, or attempting to become pregnant. Anyone unwilling to follow the study protocol.

Primary outcomes:
measure: Changes in urine pH levels. [Timeframe: Baseline to Week 12]
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in score on the Metabolic Screening Questionnaire.
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Citruslabs
state: California
Study officials:
References:
Clinical trial NCT01434797: Value of PET/CT Imaging in the Diagnosis of Permanent Central Venous Catheters Infection
Official title: Prospective Study on the Usefulness and Diagnostic Value of F-18-FDG PET/CT in the Diagnosis of Permanent Central Venous Catheters Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infection
Keywords: Infection
Permanent central venous catheter
Device Related
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
First posted: 2011-09-15
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with pathology requiring permanent central venous catheter will be selected mainly from nephrology and oncology departments . They might also be selected from other deparments.

Brief summary: The study hypothesis is that F-18-FDG PET/CT and microcalorimetry might have a diagnostic value in the detection of permanent central venous catheters (PCVC) infection when conventional means of PCVC infection detection are non-conclusive.

Detailed description: Permanent central venous catheters are frequently infected and therefore need surgical removal. When a clear diagnostic for infection cannot be defined, catheter removal might be at risk for the patient, for the therapeutic follow-up and in terms of costs. PET/CT and microcalorimetry might help giving conclusive diagnostic of catheter infection.

Eligibility criteria: Inclusion Criteria:

* patients with confirmed catheter infection requiring surgical removal
* patients with probable catheter infection requiring surgical removal
* patients with planned removal of uninfected catheter
* ≥18years old

Exclusion Criteria:

* extreme claustrophobia
* pregnancy and breastfeeding
* severe septicemia

Primary outcomes:
measure: Diagnostic value (sensitivity and sensibility, positive/negative predictive value) of F-18-FDG PET/CT imaging in the detection of CVCP infection
timeFrame: 6 months
Secondary outcomes:
measure: Diagnostic value (sensitivity and sensibility, positive/negative predictive value) of microcalorimetry in the detection of CVCP infection
timeFrame: 6 months
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois, Nuclear Medicine
state: Vaud
Study officials:
affiliation: Centre Hospitalier Universitaire Vaudois and University of Lausanne
name: John O Prior, PhD MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06701097: Emotion Regulation Training, Nursing Student, and Alexithymia
Official title: The Effect of Emotion Regulation Training on the Levels of Alexithymia in Nursing College Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alexithymia
Emotion Regulation
Keywords: Alexithymia
Nursing
Emotion regulation
Student
Lead sponsor: Ankara Medipol University
Sponsor class: OTHER
First posted: 2024-11-22
Enrollment: 74
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study aimed to investigate the effects of emotional regulation training, which is a prepared based on the cognitive behavioral approach, on alexithymia in nursing students.

Detailed description: This study aimed to reduce alexithymia levels in nursing students with emotion regulation training based on a cognitive behavioral approach. The study was conducted with 74 nursing students, 37 in the intervention group and 37 in the control group, studying at a foundation university in the 2023-2024 academic year. The study data were collected using the data collection form and the Toronto Alexithymia Scale-20 (TAS-20). Data collection tools were applied three times as pre-post and follow-up tests. Male and female students who met the inclusion criteria of the study were determined by using the pre-test of the population. For the sample group to represent the population, students with high levels of alexithymia were identified by stratification by determining the class and gender ratios. Then, students were assigned to intervention and control groups by randomization. The 7-session training program prepared for the students in the intervention group was applied. No intervention was made to the control group during the implementation. After the training sessions were completed, post-test data were collected. Follow-up measurements were made three months later.

Eligibility criteria: Inclusion Criteria:

* To be a student of the nursing department
* Agree to participate in the study

Exclusion Criteria:

* Having received psychological support within the last 10 years
* Having a psychiatric disorder
* Not being a citizen of the Republic of Turkey

Primary outcomes:
measure: Toronto Alexithymia-20 Scale
timeFrame: - Before training. -immediately after the training is over. -Three months after training.
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Medipol University
Study officials:
References:
Clinical trial NCT02564497: A Study to Compare the Pharmacokinetics of Belatacept Using Active Pharmaceutical Ingredient Manufactured by Process E Relative to Process C
Official title: A Randomized, Open-label, Parallel-group, Single-dose, Biocomparability Study of the Pharmacokinetics of Belatacept Drug Products Using Active Pharmaceutical Ingredient Manufactured by Process E Relative to Active Pharmaceutical Ingredient Manufactured by Process C in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Renal Transplantation
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2015-09-30
Enrollment: 491
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of the study is to compare the Pharmacokinetics (PK) of Process E belatacept relative to Process C belatacept in Healthy subjects


Eligibility criteria: Inclusion Criteria:

1. Signed Informed Consent
2. Target population: Healthy males and females.
3. Males and females, ages 18 to 55 years, inclusive.
4. Women of child bearing potential (WOCBP) with negative serum or urine pregnancy test
5. Women must not be breastfeeding
6. Men and WOCBP must agree to follow instructions for contraception

Exclusion Criteria:

1. History of TB, malignancy, any other chronic or acute infecton or disease.
2. History of acute or chronic medical illness
3. Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population.
4. History of allergy to belatacept or related compounds -

Primary outcomes:
measure: Area Under the Serum Concentration-time Curve From Time Zero Extrapolated to Infinite Time (INF) of Belatacept.
timeFrame: Day 1 to Day 71
measure: Maximum Observed Serum Concentration (Cmax) of Belatacept
timeFrame: Day 1 to Day 71
Secondary outcomes:
measure: Time of Maximum Observed Serum Concentration (Tmax)
timeFrame: Day 1 to Day 71
measure: Area Under the Serum Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUC 0-T)
timeFrame: Day 1 to Day 71
measure: Total Body Clearance (CLT)
timeFrame: Day 1 to Day 71
measure: Volume of Distribution at Steady State (Vss)
timeFrame: Day 1 to Day 71
measure: Half Life (T-HALF)
timeFrame: Day 1 to Day 71
Other outcomes:
Locations:
city: Austin
country: United States
facility: PPD Development
state: Texas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT03761797: A Long-term Study on the Side Effects of TRADIANCE in Japanese Patients With Type 2 Diabetes
Official title: Post Marketing Surveillance in Japan on Long Term Drug Use of TRADIANCE® Combination Tablets AP and BP in Patients With Type 2 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2018-12-03
Enrollment: 1164
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with type 2 Diabetes Mellitus

Brief summary: Study objectives is to investigate the safety of long-term daily use of TRADIANCE® Combination Tablets AP and BP in Japanese patients with Type 2 Diabetes mellitus (T2DM) used in routine care.


Eligibility criteria: Inclusion Criteria:

* Japanese patients with Type 2 Diabetes mellitus (T2DM) who are prescribed with TRADIANCE® Combination Tablets AP or BP
* Patients who have never been treated with TRADIANCE® Combination Tablets AP or BP before enrolment

Exclusion Criteria:

None

Primary outcomes:
measure: Number of Participants With Adverse Drug Reactions (ADRs)
timeFrame: From first dose of study medication until last dose + 7 days, up to 102.1 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Nippon Boehringer Ingelheim Co., Ltd
Study officials:
affiliation: zzCDMJP_PV_PMS@boehringer-ingelheim.com
name: Rie Ikeda, 81364172200
role: STUDY_CHAIR
References:
citation: Inagaki N, Nishimoto T, Nishiya Y, Nitta D. Safety and effectiveness of empagliflozin and linagliptin fixed-dose combination therapy in Japanese patients with type 2 diabetes: final results of a one-year post-marketing surveillance study. Expert Opin Drug Saf. 2023 Feb;22(2):153-163. doi: 10.1080/14740338.2022.2107200. Epub 2022 Aug 16.
Clinical trial NCT00288197: A Study To Assess The Efficacy And Safety Of Voriconazole In Chinese Patients With Serious Deep Tissue Fungal Infections
Official title: An Open, Prospective, Uncontrolled, Multi-Center Study To Evaluate The Efficacy And Safety Of Voriconazole In Chinese Subjects With Proven Or Probable Serious Invasive Fungal Infections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Invasive Fungal Infections
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-02-07
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and safety of voriconazole in Chinese patients with proven or probable deep tissue fungal infections.


Eligibility criteria: Inclusion Criteria:

* Subjects with proven or probable invasive fungal infections including subjects who have failed to respond to, or have an intolerance to other approved antifungal treatments and with approval for salvage treatment by Principal Investigator and Pfizer.

Exclusion Criteria:

* Subjects who are showing continuing improvement with other antifungal agents, including amphotericin B, itraconazole, nystatin, fluconazole, flucytosine and miconazole.
* Subjects with an invasive fungal infection caused by a fungus (such as Mucor) that is not in the antifungal spectrum of voriconazole.

Primary outcomes:
measure: Percent of subjects with a Global Efficacy assessment of either "cured" or "improved" by Week 6 visit.
Secondary outcomes:
measure: Safety assessment during the study period (Adverse events observed between start of treatment and follow-up visit).
measure: Percent of subjects with a Global Efficacy assessment of either "cured" or "improved" at the time when IV administration is completed
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Pfizer Investigational Site
state: Guangdong
city: Wuhan
country: China
facility: Pfizer Investigational Site
state: Hubei
city: Wuhan
country: China
facility: Pfizer Investigational Site
state: Hubei
city: Beijing
country: China
facility: Pfizer Investigational Site
city: Beijing
country: China
facility: Pfizer Investigational Site
city: Hangzhou
country: China
facility: Pfizer Investigational Site
city: Shanghai
country: China
facility: Pfizer Investigational Site
city: Shanghai
country: China
facility: Pfizer Investigational Site
city: Tianjin
country: China
facility: Pfizer Investigational Site
city: Tianjin
country: China
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01326897: Healthy Homes/Healthy Families
Official title: Healthy Homes/Healthy Families
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Diseases
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
name: Cancer Coalition of South Georgia
First posted: 2011-03-31
Enrollment: 510
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to learn how to make homes more supportive of healthy eating and physical activity. As part of the study, participants will be randomly assigned to one of two groups. One group will receive materials with information on healthy eating and physical activity. The materials will be mailed 3 times over a 5 month period. The other group will work with a coach to make their homes more supportive of healthy eating and physical activity. Working with a coach involves 3 home visits and 4 coaching telephone calls over a 5 month period. This group will also receive materials by mail 4 different times. All participants will be asked to complete 7 telephone interviews over a 1 year period. Participants will also be asked to wear an accelerometer, a small portable device that tracks movement from physical activity, for 7 days at 2 different points in the study.


Eligibility criteria: Inclusion Criteria:

* Female
* 35-65 years old
* BMI greater than or equal to 25
* Speak English
* Must live with at least one other person
* Live within 30 miles of 1 of 9 clinics referring patients in the study
* Must have no contraindications for physical activity
* Must have no contraindications for participating in a medically unsupervised study

Exclusion Criteria:

* 1 person per household

Primary outcomes:
measure: Diet & Physical Activity
timeFrame: Baseline, 6 months, and 12 months
Secondary outcomes:
measure: Weight
timeFrame: Baseline, 6 months, and 12 months
measure: Changes in the home physical and social environment
timeFrame: Baseline, 6 months, and 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Emory University, Rollins School of Public Health
name: Michelle C Kegler, DrPH, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University, Rollins School of Public Health
name: Julie Gazmararian, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kegler MC, Haardorfer R, Alcantara IC, Gazmararian JA, Veluswamy JK, Hodge TL, Addison AR, Hotz JA. Impact of Improving Home Environments on Energy Intake and Physical Activity: A Randomized Controlled Trial. Am J Public Health. 2016 Jan;106(1):143-52. doi: 10.2105/AJPH.2015.302942.
citation: Haardorfer R, Alcantara IC, Patil D, Hotz J, Kegler MC. Physical activity profiles of overweight and obese women in rural Georgia. JAMA Intern Med. 2014 Jan;174(1):148-9. doi: 10.1001/jamainternmed.2013.11571. No abstract available.