louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00738192: Comparison of Analgesic Efficacy of Fentanyl, Sufentanil and Butorphanol After Remifentanil Anesthesia
Official title: Comparison of Analgesic Efficacy of Fentanyl, Sufentanil and Butorphanol After Remifentanil Anesthesia in Gynecological Laparoscopic Surgeries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Keywords: Postoperative analgesia
Opioids
Laparoscopic surgery
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2008-08-20
Enrollment: 150
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Fast awakening from anesthesia is one of the major characteristics of remifentanil-associated anesthetic induction and maintenance, whereas corresponding pain during awakening influences patient's rehabilitation strongly. In addition, such early postoperative pain results in significant stress responses, which displays as further release of stress hormones such as cortisol and β-endorphin as well. How to prevent such acute pain resulting from remifentanil's fast metabolism endows clinical significance. This study is designed to compare the analgesic efficacy of fentanyl, sufentanil and butorphanol delivered after gynecological laparoscopic surgeries that underwent remifentanil induction and maintenance, and investigate corresponding influence on the levels of blood cortisol and β-endorphin.


Eligibility criteria: Inclusion Criteria:

1. ASA physical status I-II
2. Chinese
3. 19-45yr
4. Selective laparoscopic surgeries

Exclusion Criteria:

1. Allergy to opioids, a history of the use of centrally-acting drugs of any sort, chronic pain and psychiatric diseases records
2. Participants younger than 18 years, older than 45 years or pregnancy was eliminated
3. Due to the significant changes in vital signs might affect cognition of pain and that of sensation, over 20% variation of these records from the baselines or below 92% of SpO2 under 20-40% nasal tube oxygen at any time should be excluded from the study
4. Those who were not willing to or could not finish the whole study at any time

Primary outcomes:
measure: VAS ratings of pain
timeFrame: 0 min after awake from anesthesia; 5,10,15,20 and 30min after awake from anesthesia
Secondary outcomes:
measure: Hemodynamics of patients
timeFrame: 30min before operation; every 10min during operation; 5,10,15,20,30 and 60min after operation
measure: Sedative ratings with VAS system
timeFrame: 0,5,10,15,25,45 and 60min after awake from anesthesia
measure: Overall VAS satisfaction ratings
timeFrame: 1 h after operation
measure: Blood cortisol and β-endorphin levels
timeFrame: 0, 10min before the end of surgeries, 10min, 1h and 6h after operation
measure: Side effects
timeFrame: 1 h after operation
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Maternal and Child Health Care Hospital
state: Jiangsu
Study officials:
affiliation: Nanjing Medical University
name: XiaoFeng Shen, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01438892: Impact Of RA Therapy Compliance On Patient-Reported Outcomes
Official title: Impact Of RA Therapy Compliance On Patient-Reported Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Keywords: rheumatoid arthritis
therapy compliance
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-09-22
Enrollment: 396
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with modertate to severe Rheumatoid Arthritis

Brief summary: Several observational studies have evaluated the comparative treatment costs associated with each agent, particularly those within the anti-TNF class, but few have evaluated the impact of therapy compliance, persistence, treatment patterns on patient reported outcomes, healthcare utilization and costs, using a provider database. This study is designed to fill in this information gap.

Detailed description: Cohort observational

Eligibility criteria: Inclusion Criteria:

* Adults with moderate to severe RA who are currently using a DMARD

Exclusion Criteria:

* Psoriatic Arthritis (PsA), Psoriasis (PsO), SSystemic Lupus Erythematosus (SLE), Non-Disease modifying anti-rheumatic disease (non-DMARD) use

Primary outcomes:
measure: HAQ
timeFrame: 12 months
measure: 36-Item Short-Form Health Survey (SF-36)
timeFrame: 12 months
Secondary outcomes:
measure: Compliance
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00224692: Analgesic Effect in Children of Low-Dose Ketamine for Mucositis Treated by Patient-Controlled Analgesia With Morphine
Official title: MK III Trial: Analgesic Effect in Children of Low-Dose Ketamine for Mucositis Treated by Patient-Controlled Analgesia With Morphine
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Cancer
Mucositis
Keywords: Mucositis
Pain
Morphine
Ketamine
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2005-09-23
Enrollment: 50
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hypothesis : Low dose ketamine has an analgesic effect in children with mucositis treated by patient-controlled analgesia with morphine

Detailed description: Double blind versus placebo multicenter Phase III trial of kétamine in children with chemotherapy induced-mucositis treated by patient-controlled analgesia with morphine

Eligibility criteria: Inclusion Criteria:

* Painful mucositis
* Child from 5 to 18 years.
* Presenting mucitis induced by chemotherapy or a conditioning of graft hematopoïetic.
* A pain not controlled by systematic paracetamol (10mg/kg/4h) or a the propacetamol (20mg/kg/4h).
* Not presenting a neurological or psychological difficulty at the use of the PCA or a EVA.
* First morphine amount going back to less 48h, and lass administration dating of more than 4h at the time of the beginning of the perfusion of Ketamine/placebo (EVA \> 30 after stop morphine).
* Assent signed by the parents and each time possible by the child.

Exclusion Criteria:

* The child was already included in the study.
* The age of psychomotor development is lower than 5 years
* Presence of a depression or a major depressive episode according to definition DSM IV.
* Hepatic or renal anomaly major (rank 3 or 4 of the scale of toxicity NCI CTC v2.0)
* Bilirubin\>3N
* Gamma WP\>3N
* SGOT or SGPT \>5N
* Creatinin\>3N

Primary outcomes:
measure: Pain score
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Robert Debré Service Pédiatrie-Hémato-immunologie
state: Ile de France
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Evelyne JACQZ-AIGRAIN, Pr,MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00465192: Efficacy and Safety of 17-Beta Estradiol in Treatment of Atrophic Vaginitis
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study Comparing the Efficacy and Safety of 17-Beta Estradiol 10 Micrograms and 25 Micrograms (Vagifem) Doses in Treatment of Estrogen Deficiency-Derived Atrophic Vaginitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Menopause
Postmenopausal Vaginal Atrophy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2007-04-24
Enrollment: 230
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial was conducted in the United States of America (USA). This trial aimed for a comparison between the effect of two different doses of estradiol on parameters related to efficacy and safety.


Eligibility criteria: Inclusion Criteria:

* Generally healthy
* Postmenopausal
* Hysterectomized or non-hysterectomized
* Moderate or severe vaginal dryness and soreness

Exclusion Criteria:

* Known, suspected, or past history of breast cancer
* Known, suspected, or past history of hormone-dependent tumor
* Genital bleeding of unknown etiology
* Acute thrombophlebitis or thromboembolic disorders or a past history of these conditions, associated with previous estrogen use
* Vaginal infection
* Use of exogenous corticosteroids or sex hormones within 8 weeks of starting active treatment in study
* Use of vaginal, oral or vulvar homeopathic preparations within seven days of starting active treatment in study
* History of treatment with diethylstilbestrol

Primary outcomes:
measure: Relief of vaginal symptoms
timeFrame: following 12 weeks of treatment.
Secondary outcomes:
measure: Adverse events
measure: Hematology and chemisty tests, and endometrial biopsy
measure: Vaginal and urethral cytology, and grading of vaginal health
Other outcomes:
Locations:
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Bachmann G, Lobo RA, Gut R, Nachtigall L, Notelovitz M. Efficacy of low-dose estradiol vaginal tablets in the treatment of atrophic vaginitis: a randomized controlled trial. Obstet Gynecol. 2008 Jan;111(1):67-76. doi: 10.1097/01.AOG.0000296714.12226.0f.
Clinical trial NCT03136692: Analysis of De-identified Data From Commercially-available App Lose It!
Official title: Analysis of De-identified Data From Commercially-available App Lose It!
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Overweight and Obesity
Keywords: app
weight loss
diet
behavior
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: FitNow Inc
First posted: 2017-05-02
Enrollment: 7007
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: New app users located in the U.S. and Canada, between 18 and 80 years of age, that are overweight (25 \< BMI \< 30) or obese (BMI \> 30), who actively used the app each month from January to May of 2016, defined as users who logged food at least 8 times during the first or second half of each month (January, February, March, April and May).

Brief summary: The study team analyzed de-identified user data provided by the commercial app Lose It!, an entity of FitNow, Inc.

Detailed description: The study team analyzed de-identified user data collected by Lose It! for the purposes of investigating behavioral aspects of weight loss and maintenance, including engagement with the platform; user-reported data on diet, exercise, and other behaviors; data generated by Lose It! describing macronutrient or total calorie intake; periodicity of weight-related actions; user-reported demographic information; and any data from linked applications within Lose It!. All data was anonymized and exchanged as limited data sets.

Eligibility criteria: Inclusion Criteria:

- New app users located in the U.S. and Canada, between 18 and 80 years of age, that are overweight (25 \< BMI \< 30) or obese (BMI \> 30), who actively used the app each month from January to May of 2016, defined as users who logged food at least 8 times during the first or second half of each month (January, February, March, April and May).

Exclusion Criteria:

-

Primary outcomes:
measure: Percent body weight lost
timeFrame: five months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Lawrence Cheskin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hill C, Weir BW, Fuentes LW, Garcia-Alvarez A, Anouti DP, Cheskin LJ. Relationship Between Weekly Patterns of Caloric Intake and Reported Weight Loss Outcomes: Retrospective Cohort Study. JMIR Mhealth Uhealth. 2018 Apr 16;6(4):e83. doi: 10.2196/mhealth.8320.
Clinical trial NCT00859092: Promotion of Thickened Feeds to Manage Newborns With Feeding Difficulties
Official title: Promotion of Thickened Feeds to Manage Newborns With Feeding Difficulties
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Swallowing Dysfunction
Lead sponsor: Eastern Virginia Medical School
Sponsor class: OTHER
First posted: 2009-03-10
Enrollment: 15
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Swallowing dysfunction and delay of oral feeding skills in premature infants significantly delay discharge from the hospital. Thickening oral formula or breast milk feeds with commercial thickeners and rice cereal has been used in some nurseries with the goal of promoting development of adequate feeding skills. The objective of this pilot study is to examine the effect of thickened feeds on premature infants with oral feeding difficulties due to dysfunction secondary to immature swallowing.

Hypotheses:

* Thickened feeds will lead to a reduction in symptoms secondary to immature swallowing in 32-40 weeks gestational age infants when compared to non-thickened feeds
* Thickened feeds will promote transition to hospital discharge.


Eligibility criteria: Inclusion Criteria:

1. apneas and bradycardias with oral feedings
2. oxygen desaturations with oral feedings
3. excessive coughing or gagging with oral feedings

Exclusion Criteria:

1. less than 32 weeks adjusted gestational age
2. greater than 40 weeks adjusted gestational age

Primary outcomes:
measure: Elimination of symptoms associated with immature swallowing
timeFrame: 2 days
Secondary outcomes:
measure: Promotes transition to discharge from hospital
timeFrame: one week
Other outcomes:
Locations:
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
Study officials:
affiliation: Children's Hospital of The King's Daughters
name: David Oelberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02679092: Mifepristone Versus Osmotic Dilators in Conjunction With Misoprostol for Cervical Preparation Prior to D&E at 14-19 Weeks
Official title: Mifepristone Versus Osmotic Dilators in Conjunction With Misoprostol for Cervical Preparation Prior to D&E at 14-19 Weeks
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Legally Induced Abortion Without Mention of Complication
Keywords: Induced Abortion
Mifepristone
Dilation and Evacuation
Cervical Preparation
Osmotic Dilators
Misoprostol
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2016-02-10
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Dilation and evacuation (D\&E) is a common surgical procedure in the U.S. Adequate pre-operative preparation of the uterine cervix is an important part of preventing complications of the procedure. Traditionally, the uterine cervix is prepared for the procedure using water-attracting dilators, which are placed via a speculum exam and cause discomfort for many women. The objective of this study is to investigate the comparative effectiveness of mifepristone (an oral tablet) versus dilators for cervical preparation for D\&E.


Eligibility criteria: Inclusion Criteria:

* \>18 Years Old
* Viable, Singleton pregnancy
* Voluntarily seeking abortion between 14-19 weeks gestation
* Able to give informed consent and comply with study protocol
* Fluent in English or Spanish

Exclusion Criteria:

* Allergy to study drugs

Primary outcomes:
measure: Procedure Time
timeFrame: Intraoperative
Secondary outcomes:
measure: Cervical Dilation
timeFrame: Baseline
measure: Total Procedure Time
timeFrame: Measured at clinic visit and on OR day, over 2 day period
measure: Difficulty of Procedure, as reported by clinician
timeFrame: Measured within 5 minutes after procedure
measure: Complications/Adverse Events
timeFrame: Intraoperatively
measure: Pain Perceived by Patient
timeFrame: Intraoperatively "Measured during dilator placement"
measure: Overall Patient Experience
timeFrame: Measured post-operatively (30 minutes prior to discharge)
Other outcomes:
Locations:
city: San Jose
country: United States
facility: Planned Parenthood Mar Monte
state: California
Study officials:
affiliation: Stanford University
name: Principal Investigator
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03134989: Cochlear Response Telemetry and Hearing Preservation
Official title: Association Between Intra-Operative Cochlear Response Telemetry and Hearing Preservation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Conditions: Hearing Impairment, Sensorineural
Keywords: cochlear implantation, electrocochleography
Lead sponsor: Cochlear
Sponsor class: INDUSTRY
First posted: 2017-05-01
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The main purpose of this study is to monitor the response from the cochlea as the electrode is inserted during the operation to receive a cochlear implant. The Cochlear Response Telemetry tool aims to measure the response from the cells within the cochlea and may be useful in the future to help to improve the surgical technique and potentially help surgeons better preserve any natural hearing that is available. The measurements are obtained using the cochlear implant and sound processor while a sound is presented to the ear through an earphone (like an earplug) placed into the ear canal.


Eligibility criteria: Inclusion Criteria:

* Candidate for cochlear implantation (with CI522, CI532, CI622, CI632 or Hybrid-L24 (US only) according to local indications
* 18 years of age or older at the time of enrolment
* Pre-operative audiometric threshold in the implanted ear at 500 Hz of better than or equal to 80 dB HL
* Willingness to participate in and to comply with all requirements of the protocol

Exclusion Criteria:

* Prior cochlear implantation in the ear to be implanted
* Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array
* Abnormal cochlear/nerve anatomy on pre-operative CT or MRI imaging (excluding a mild Mondini malformation or Large Vestibular Aqueduct Syndrome)
* Deafness due to lesions of the acoustic nerve or central auditory pathway
* Diagnosis of auditory neuropathy
* Active middle-ear infection
* Additional handicaps that would prevent participation in evaluations
* Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedure and investigational device

Primary outcomes:
measure: Change in Low-frequency Hearing Thresholds Assessed Audiometrically Pre- and Post-operatively.
timeFrame: Baseline measurement (pre-operatively) compared to 4 to 6 weeks post-surgery
Secondary outcomes:
measure: Change in Low-frequency Hearing Thresholds Assessed Audiometrically Pre- and Post-operatively.
timeFrame: Baseline (pre-operative) compared to 3 months post cochlear implant activation
measure: Correlation of Preoperative High-frequency Hearing Thresholds and Cochlear Microphonic Response (Number of Electrodes Inserted When CM Detected).
timeFrame: Intraoperative
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
Study officials:
References:
Clinical trial NCT02884089: A Study of the Effect of Abemaciclib on Metformin and Iohexol in Healthy Participants
Official title: Effect of Abemaciclib on Metformin Pharmacokinetics and Iohexol Clearance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2016-08-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study will look at how a single dose of abemaciclib will impact the body's ability to get rid of two other drugs, metformin and iohexol. In addition, this study will evaluate the effect of a single dose of abemaciclib on kidney function by measuring blood and urine markers. Side effects will also be documented.

Each participant will complete four study periods. During each study period, participants will stay in the clinical research unit for nine days and eight nights.

The study will last approximately 10 weeks, not including screening. Screening is required within 28 days prior to the start of the study.

This study is for research purposes only and is not intended to treat any medical condition.


Eligibility criteria: Inclusion Criteria:

* Healthy surgically sterile or postmenopausal females and sterile males
* Have a body mass index (BMI) between 18 and 32 kilograms per meter squared (kg/m²), inclusive at screening

Exclusion Criteria:

* Have known allergies to abemaciclib, metformin, iodine, iohexol, related compounds, or any components of the formulation
* Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
* Show evidence and/or positive antibodies of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C

Primary outcomes:
measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Metformin
timeFrame: Pre dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36 hours (h) post dose
measure: Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Metformin
timeFrame: Pre dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36 hours (h) post dose
measure: Pharmacokinetics (PK): Renal Clearance (CLr) of Metformin
timeFrame: Pre dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36 hours (h) post dose
Secondary outcomes:
measure: Pharmacokinetics (PK): Renal Clearance (CLr) of Iohexol
timeFrame: Pre infusion, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6 hours post infusion
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Dallas Clinical Research Unit
state: Texas
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: