louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03184363: Efficacy and Safety of DWP450 for Treating Crows Feet Lines(CFL) in Combination With Glabellar Lines(Extension Study)
Official title: Efficacy and Safety of DWP450 for Treating Crows Feet Lines(CFL) in Combination With Glabellar Lines: Multi-center, Single Arm, Open, Extension Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Crow's Feet Lines
Glabellar Lines
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2017-06-12
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to explore the Efficacy and Safety of DWP450 for treating Crows Feet Lines(CFL) in combination with glabellar line(GL) as extension study of phase 3 study for CFL.


Eligibility criteria: Inclusion Criteria:

* Male or female of at least 18 to 75 years old
* moderate-to-severe CFL at maximum smile on the FWS as rated by the investigator
* moderate-to-severe GL at maximum frawn on the FWS as rated by the investigator
* Subject who has completed phase 3 study for CFL.

Primary outcomes:
measure: Subject Assessment of Satisfaction of Appearance
timeFrame: At 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03722563: Total Laparoscopic Hysterectomy With Sacrocolpopexy Versus Total Laparoscopic Hysterectomy With Lateral Suspension in Patients With Pelvic Organ Prolapse
Official title: Comparison of Total Laparoscopic Hysterectomy With Sacrocolpopexy Versus Total Laparoscopic Hysterectomy With Lateral Suspension in Patients With Pelvic Organ Prolapse: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Organ Prolapse
Keywords: lateral suspension
laparoscopic hysterectomy
pelvic organ prolapse
sacrocolpopexy
Lead sponsor: Antalya Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2018-10-29
Enrollment: 80
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This prospective randomized surgical trial is designed to compare objective and subjective outcomes of total laparoscopic hysterectomy with sacrocolpopexy versus total laparoscopic hysterectomy with lateral suspension for the treatment of pelvic organ prolapse


Eligibility criteria: Inclusion Criteria:

* Women with symptomatic pelvic organ prolapse stage II or higher (according to the International Continence Society Pelvic Organ Prolapse quantification system - POPQ) in anterior and/or apical (central) compartment that require surgical management

Exclusion Criteria:

* Patients that are not candidates for general anesthesia or laparoscopy
* Inability to consent
* history of hysterectomy
* history of anterior or apical pelvic organ prolapse surgery
* history of urinary incontinence surgery
* pregnancy or breast-feeding during the study period
* suspicious adnexal masses or other factors that may indicate pelvic malignancy

Primary outcomes:
measure: Rate of objective cure
timeFrame: 12 months
Secondary outcomes:
measure: Patient Global Impression of Improvement (PGI-I)
timeFrame: 12 months
measure: International Consultation of Incontinence Questionnaire - Short Form (ICIQ-SF)
timeFrame: 12 months
measure: International Consultation on Incontinence Questionnaire on Vaginal Symptoms (ICIQ-VS)
timeFrame: 12 months
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Antalya Training and Research Hospital
state: Muratpaşa
Study officials:
affiliation: Antalya Training and Research Hospital
name: Bekir Sıtkı İsenlik, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01792063: Two Different Preparations of Sevoflurane in Induction
Official title: A Randomized Clinical Trial on the Efficiency, Hemodynamic Effects and Patient Comfort of Two Different Preparations of Sevoflurane After Vital Capacity Rapid Inhalation Induction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coughing on Induction
Vapors; Inhalation
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2013-02-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: In our study we aim to study the effects of two preparations of Sevoflurane in vital capacity rapid inhalation induction.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing abdominal surgery

Exclusion Criteria:

* Patients with any cardiovascular or respiratory disease, usage of any kind of sedative drug, expected airway difficulty and obese patients (BMI\>35) will be excluded from the study

Primary outcomes:
measure: effect of different preparations of sevoflurane on Induction on hypnosis time
timeFrame: 1 hour
Secondary outcomes:
measure: effect of different sevoflurane preparations on hemodynamics
timeFrame: 1 hour
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Cerrahpasa Medical Faculty Anesthesiology and Reanimation Department
state: Fatih
Study officials:
References:
citation: Baker MT. Sevoflurane: are there differences in products? Anesth Analg. 2007 Jun;104(6):1447-51, table of contents. doi: 10.1213/01.ane.0000263031.96011.36.
Clinical trial NCT05021263: Does IV Magnesium Improve Quality of Recovery With ERAS Protocols in Laparoscopic Colorectal Surgery?
Official title: Does IV Magnesium Improve Quality of Recovery With ERAS Protocols in Laparoscopic Colorectal Surgery?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colo-rectal Cancer
Anesthesia
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2021-08-25
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is a randomized, double blind controlled trial examining the impact of incorporating a single intraoperative intravenous magnesium bolus and infusion into a preexisting Enhanced Recovery After Surgery (ERAS) protocol for colorectal surgery in place of preoperative oral pregabalin. These protocols are pathways designed with the goal of achieving early surgical recovery by utilizing a constellation of perioperative care techniques that include the use of opioid-sparing pain medications, minimally invasive approaches, and prevention of post-operative nausea and vomiting, among others. Intravenous magnesium has shown to be an effective non-opioid analgesic in abdominal surgeries that decreases total opioid consumption, pain, and improves recovery. The purpose of this study is to evaluate whether or not the addition of intravenous magnesium to our institutional ERAS protocol will improve specific outcome measures, and provide additional benefits when compared to oral preoperative pregabalin. The primary outcome is the patient's quality of recovery based on the "Quality of Recovery - 40 Questionnaire" (QOR 40), and secondary outcomes will be opioid consumption, pain, shivering, sedation scores, acute kidney injury, gastrointestinal function, respiratory function, and hospital length of stay.


Eligibility criteria: Inclusion Criteria:

* Elective Laparoscopic Colorectal Surgery
* Age 18-75
* ASA (American Society of Anesthesiologists) Physical Status Classification 1-3

Exclusion Criteria:

* Current use of Buprenorphine/Suboxone or Methadone maintenance treatment
* Known history of substance abuse
* Use of intra- and/or postoperative Ketamine or Lidocaine infusion
* Pre- or postoperative placement of Epidural catheter
* Inability to speak English or communicate verbally
* Chronic Kidney Disease (CKD) Stage 3
* Hepatic Cirrhosis
* Neuromuscular disease
* Heart block on EKG
* Uncontrolled diabetes with Hba1c \> 8%
* Known allergies to study drugs

Primary outcomes:
measure: Quality of Recovery 40 Questionnaire
timeFrame: Postoperative Day 0-2
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson
state: Pennsylvania
Study officials:
References:
Clinical trial NCT02379663: Prophylaxis of Deep Vein Thrombosis Following Total Hip Arthroplasty
Official title: Efficacy and Safety for Prophylaxis of Deep Vein Thrombosis Following Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis, Hip
Femur Head Necrosis
Femoral Neck Fractures
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2015-03-05
Enrollment: 639
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This prospective study compares an oral direct factor Xa inhibitor with LMWH for thromboprophylaxis in the patients undergoing THA.


Eligibility criteria: Inclusion Criteria:

* Male or female without childbearing potential aged ≥20 years who were scheduled for elective primary THA

Exclusion Criteria:

* recent history of active bleeding or VTE
* known genetic disorder associated with bleeding tendency or any condition related with an increased risk of bleeding
* persistent blood pressure of ≥160mmHg systolic and/or ≥100 mmHg diastolic at baseline
* myocardial infarction or cerebrovascular accident within three months of the scheduled surgery
* major surgery in the prior three months
* renal insufficiency with a creatinine clearance \<60mL/min , hepatic failure combined with coagulopathy, or thrombocytopenia (platelets \< 100,000/mm³), or planned indwelling epidural catheter for \> 6 hours after the end of surgery

Primary outcomes:
measure: Major wound complication
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02652663: Liver MRI for Colorectal Cancer Liver Metastasis: Comparative Effectiveness Research for the Choice of Contrast Agents
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Cancer
Keywords: colorectal cancer
liver
MRI
contrast
gadoxetic acid
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2016-01-12
Enrollment: 500
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with newly diagnosed colorectal cancer between January 2005 and December 2010

Brief summary: Magnetic resonance imaging (MRI) has been widely used for problem-solving tool in the evaluation of hepatic lesions, and it has been shown to have better sensitivity than CT for detection of colorectal liver metastases, especially for lesions which are smaller than 1 cm. After introduction of a liver-specific hepatobiliary MR contrast agent, gadoxetic acid, gadoxetic acid-enhanced MRI (Gd-EOB-MRI) has been increasingly used for evaluation of liver lesion including CRLM. However, compared to conventional MRI with extracellular contrast agent (ECA-MRI), Gd-EOB-MRI has different pharmacodynamic characteristics, and is more expensive due to higher cost of gadoxetic acid and needs longer scan time to obtain hepatobiliary phase which is generally acquired 15 to 20 minutes after contrast injection. The purpose of this study was to compare the clinical outcome and diagnostic performance of Gd-EOB-MRI and ECA-MRI for evaluation of focal hepatic lesion in newly diagnosed colorectal cancer.


Eligibility criteria: Inclusion Criteria:

1. patients with surgically proven colorectal adenocarcinoma
2. patients who underwent abdominopelvic CT and liver MRI for initial staging before any treatment
3. no past or concurrent malignancy other than colorectal adenocarcinoma.

Exclusion Criteria:

1. precontrast abdominopelvic CT
2. precontrast liver MRI
3. liver MRI using contrast other than extracellular agent or gadoxetic acid
4. the interval between CT and liver MRI was longer than 4 weeks
5. patients who had suspected multiple hepatic metastases (\> 10) on CT
6. distant metastasis other than liver and
7. unavailable reference standard of their hepatic lesions with no pathologic confirmation or follow up imaging.

Primary outcomes:
measure: Disease free survival
timeFrame: up to 120 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03220763: Eating Away from Home and Risk of All-cause Mortality
Official title: Eating Away from Home and Subsequent Risk of All-cause Mortality in the US Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mortality
Lead sponsor: Queens College, The City University of New York
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2017-07-18
Enrollment: 9107
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population are the original respondents of the National Health and Nutrition Examination Surveys conducted in 1999-2004. The surveys include a nationally representative sample of the US, non-institutionalized population.

Brief summary: The proposed study will test the hypothesis that frequency of eating away from home meals is independently related to the prospective risk of mortality in the US population. The study will use public-domain mortality linked data from US national Surveys to address this question.

Detailed description: This study uses public domain data collected in the National Health and Nutrition Examination Surveys (NHANES) conducted in 1999-2000, 2001-2002, and 2003-2004 by the National Center for Health Statistics. Data on frequency of eating restaurant meals were collected at that time. The surveys have been linked to the National Death Index and mortality status information is available in public-release files. The investigators aim to examine if exposure to restaurant meals at baseline is prospectively linked to the risk of mortality. All data are anonymized and available in the public domain.

Eligibility criteria: Inclusion Criteria:

* National Health and Nutrition Examination Surveys, 1999-2004, respondent
* Aged 40 or older at baseline

Exclusion Criteria:

* Pregnant or lactating
* No mobile examination center exam
* No exposure information
* No National Death Index linkage
* No followup time

Primary outcomes:
measure: All-cause mortality
timeFrame: Through end date of National Death Index followup, 12/31/2011
Secondary outcomes:
measure: Cause-specific mortality
timeFrame: Through end date of National Death Index followup, 12/31/2011
Other outcomes:
Locations:
Study officials:
affiliation: Faculty at Queens College of CUNY
name: Ashima Kant, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03830463: Study to Assess the Safety and Pharmacokinetic (PK) of CTP-692 in Healthy Volunteers
Official title: A Placebo-Controlled, Double-Blind, Single Ascending Dose Study to Evaluate the Safety and Pharmacokinetic Profile of CTP-692 in Fed and Fasted Conditions in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Concert Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2019-02-05
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This study will assess the safety and pharmacokinetic (PK) profile of single ascending doses of CTP-692 in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy adult males and females between 18 and 55 years of age, inclusive
* Body weight ≥ 55 kg and BMI within the range of 18 to 32 kg/m2, inclusive

Exclusion Criteria:

* Screening laboratory measurements outside the normal range associated with potential risk for the treatment under investigation at screening and/or prior to the first dose of study drug
* Positive blood screen for human immunodeficiency virus (HIV antibody), hepatitis B virus surface antigen or hepatitis C virus antibody
* History of clinically significant central nervous system (e.g., seizures), cardiac, pulmonary, metabolic, renal, hepatic or gastrointestinal (GI) conditions
* Positive drug or alcohol test at screening or prior to the first dose of study drug

Primary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety
timeFrame: 48 hours
measure: Measurement of CTP-692 exposure in plasma under fasted conditions
timeFrame: 48 hours
measure: Measurement of CTP-692 exposure in plasma under fed conditions
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Collaborative Neuroscience Network, LLC
state: California
Study officials:
affiliation: Concert Pharmaceuticals, Inc.
name: Emily McIntyre
role: STUDY_DIRECTOR
References:
Clinical trial NCT00983463: Abundance and Distribution of Lipids and Proteins in Nonalcoholic Fatty Liver Disease (NAFLD)
Official title: Relative Abundance and Spatial Distribution of Lipids and Proteins in Nonalcoholic Fatty Liver Disease (NAFLD)
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Nonalcoholic Fatty Liver Disease
Keywords: Nonalcoholic fatty liver disease (NAFLD)
Nonalcoholic steatohepatitis (NASH)
Obesity
Lipidomics
Proteomics
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2009-09-24
Enrollment: 45
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects having bariatric surgery or elective abdominal surgery at Vanderbilt University Medical Center

Brief summary: Nonalcoholic fatty liver disease (NAFLD) is the most common type of liver disease in the United States. The incidence of NAFLD is very similar to that of obesity, type 2 diabetes, and the metabolic syndrome. The investigators hypothesize that there may be a relationship between over-nutrition, decreased physical activity and the development of fatty liver. The purpose of this study is to identify the types of fats and proteins, and the quantity of each, that are associated with increased severity of NAFLD.


Eligibility criteria: Inclusion Criteria:

* 18-65 year of age
* Undergoing elective abdominal or bariatric surgery
* May have normal or elevated ALT/AST levels

Exclusion Criteria:

* Presence of viral hepatitis
* Significant alcohol use
* Intercurrent infections
* Use of any thiazolidinediones

Primary outcomes:
measure: To identify and relatively quantify, using high performance liquid chromatography electrospray ionization mass spectrometry, select lipids and proteins present in human liver biopsies.
timeFrame: 2 years
measure: To spatially profile, using matrix assisted laser desorption ionization time of flight mass spectrometry, select lipids and proteins present in human liver biopsies.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Charles R Flynn, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilt University Medical Center
name: Najji Abumrad, MD
role: STUDY_CHAIR
References:
citation: Garcia AE, Kasim N, Tamboli RA, Gonzalez RS, Antoun J, Eckert EA, Marks-Shulman PA, Dunn J, Wattacheril J, Wallen T, Abumrad NN, Flynn CR. Lipoprotein Profiles in Class III Obese Caucasian and African American Women with Nonalcoholic Fatty Liver Disease. PLoS One. 2015 Nov 23;10(11):e0142676. doi: 10.1371/journal.pone.0142676. eCollection 2015.
Clinical trial NCT05075863: Efficacy of Letrozole Versus Clomiphene Citrate on Ovulation Induction in Patients With Polycystic Ovarian Syndrome
Official title: Efficacy of Letrozole Versus Clomiphene Citrate on Ovulation Induction in Patients With Polycystic Ovarian Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovary Syndrome
Lead sponsor: Nishtar Medical University
Sponsor class: OTHER
First posted: 2021-10-13
Enrollment: 78
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

Brief summary: We aimed this study to determine and compare frequency of induction of ovulation in women with polycystic ovarian syndrome treated with Letrozole versus clomiphene citrate as published literature shows variations.

Detailed description: Discrepancy between ovulation induction rate and pregnancy rate is related to anti-estrogenic effects on cervical mucus and endometrium and long acting gonadotrophins are more effective than clomiphene citrate. This study was aimed at comparing frequency of induction of ovulation in women with polycystic ovarian syndrome treated with Letrozole versus clomiphene citrate.

Eligibility criteria: Inclusion Criteria:

* Diagnosed cases of polycystic ovarian syndrome.

Exclusion Criteria:

* All women having endocrine disorders like thyroid disorders.
* Women having hyperprolactinemia.

Primary outcomes:
measure: Induction of ovulation was assessed by Transvaginal scan (TVS)
timeFrame: 12 to 16 days.
Secondary outcomes:
Other outcomes:
Locations:
city: Multan
country: Pakistan
facility: Nishtar Medical University Hospital
state: Punjab
Study officials:
affiliation: Nishtar Medical University
name: Rashida Parveen, FCPS
role: PRINCIPAL_INVESTIGATOR
References: