louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00212719: Controlled Study of ONO-5920 in Patients With Involutional Osteoporosis in Japan
Official title: Controlled Study of ONO-5920 in Patients With Involutional Osteoporosis in Japan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Involutional Osteoporosis
Keywords: ONO-5920, osteoporosis, bisphosphonate
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 250
Sex: FEMALE
Minimum age (years): 45
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 evaluate the efficacy and safety of ONO-5920 in patients with involutional osteoporosis.


Eligibility criteria: Inclusion Criteria:

1. A diagnosis in accordance with Criteria for the Diagnosis of Primary Osteoporosis.
2. Other inclusion criteria as specified in the study protocol.

Exclusion Criteria:

1. Patients having secondary osteoporosis or another condition that presents low bone mass.
2. Patients having findings that affect measurement of lumbar spinal bone mineral density by DXA
3. Patients that have been administered bisphosphonate derivatives.
4. Other exclusion criteria as specified in the study protocol.

Primary outcomes:
measure: Mean bone mineral density of the lumbar spine (L2-4 BMD)
Secondary outcomes:
measure: Bone mineral density at femur, fragility fractures, biochemical markers of bone turnover, lower back pain
Other outcomes:
Locations:
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Project Leader, ' Development Planning
role: STUDY_DIRECTOR
References:
citation: Hagino H, Nishizawa Y, Sone T, Morii H, Taketani Y, Nakamura T, Itabashi A, Mizunuma H, Ohashi Y, Shiraki M, Minamide T, Matsumoto T. A double-blinded head-to-head trial of minodronate and alendronate in women with postmenopausal osteoporosis. Bone. 2009 Jun;44(6):1078-84. doi: 10.1016/j.bone.2009.02.016. Epub 2009 Mar 2.
Clinical trial NCT00665119: Effects of Remifentanil on Respiratory Function in Mechanically Ventilated Patients
Official title: Effects of Remifentanil on Breathing Pattern, Respiratory Effort and Gas Exchange in Mechanically Ventilated Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Respiratory Insufficiency
Respiration, Artificial
Conscious Sedation
Keywords: Respiratory Insufficiency
Respiration, Artificial
Remifentanil
Respiratory Mechanics
Work of Breathing
Lead sponsor: Fondazione Poliambulanza Istituto Ospedaliero
Sponsor class: OTHER
First posted: 2008-04-23
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Sedation is widely used in mechanically ventilated patients. Propofol, benzodiazepines and opioids are the most used drugs. The study hypothesis is that sedation with remifentanil (an opioid drug) could improved respiratory pattern and effort in mechanically ventilated patients with rapid shallow breathing or high respiratory rate.


Eligibility criteria: Inclusion Criteria:

* pressure support ventilation or CPAP
* respiratory rate \> 35.min-1
* respiratory rate/tidal volume \> 105

Exclusion Criteria:

* vasoactive agents (dopamine lower than 5 mcg.kg-1.min-1 is not considered as vasoactive agent)
* body temperature \> 38 °C
* Glasgow Coma Scale \< 9
* FIO2 \> 0.6
* PEEP \> 10 cmH2O
* pH \< 7.30

Primary outcomes:
measure: respiratory rate/tidal volume
timeFrame: before and after remifentanil infusion; before and after placebo infusion.
measure: pressure-time product
timeFrame: before and after remifentanil infusion; before and after placebo infusion.
Secondary outcomes:
measure: double product of respiratory system
timeFrame: before and after remifentanil infusion; before and after placebo infusion.
measure: dynamic intrinsic PEEP
timeFrame: before and after remifentanil infusion; before and after placebo infusion.
measure: adverse events
timeFrame: during all the study period
measure: arterial pH
timeFrame: before and after remifentanil infusion; before and after placebo infusion.
measure: level of sedation (RASS)
timeFrame: before and after remifentanil infusion; before and after placebo infusion.
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: Intensive Care Unit, Fondazione Poliambulanza Istituto Ospedaliero
Study officials:
affiliation: Fondazione Poliambulanza Istituto Ospedaliero
name: Giuseppe Natalini, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Natalini G, Di Maio A, Rosano A, Ferretti P, Bertelli M, Bernardini A. Remifentanil improves breathing pattern and reduces inspiratory workload in tachypneic patients. Respir Care. 2011 Jun;56(6):827-33. doi: 10.4187/respcare.01014. Epub 2011 Feb 11.
Clinical trial NCT06919419: HOTSPOT Study: Implement and Evaluate the PrEP Implementation Strategy
Official title: The HOTSPOT Study Hybrid Implementation-effectiveness Study to Optimize HIV Testing and Prep in a Southern Jail
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: PrEP
HIV
Incarceration
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2025-04-09
Enrollment: 3600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults incarcerated at the Dallas County Jail

Brief summary: The goal of this study is to measure the implementation and effectiveness of a multicomponent strategy for PrEP for people who are incarcerated at the Dallas County Jail. Specifically, based on a patients risk score on an electronic medical record HIV prediction model, referrals from providers and/or patient self-referrals, a PrEP patient navigator will meet with individuals at the jail to discuss HIV risk, offer HIV/STI testing if not yet completed and offer education around PrEP with referrals to community-based PrEP providers.

Detailed description: The objective of Aim 3 is to deploy the multicomponent strategy that was refined in Aim 2 and evaluate its impact on PrEP implementation and related clinical outcomes using iterative quantitative and qualitative assessments. The investigators' approach will be to utilize the EPIS framework (Exploration, Preparation, Implementation, Sustainment) across the jail-to-community continuum. The investigators will use mixed-methods to evaluate implementation process measures and an interrupted time series design to measure clinical outcomes for PrEP evaluations and linkage, as well as HIV/STI testing and diagnoses. The investigators' expected outcome is to define a feasible, acceptable and effective PrEP implementation strategy for jails.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Incarcerated in Dallas County Jail

Exclusion Criteria:

* Severe medical or psychiatric disability making participation unsafe
* Unable to provide consent
* Not remaining in the local area after release from custody

Primary outcomes:
measure: Linkage to PrEP care
timeFrame: Within 90 days of release from jail
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Dallas County Jail
state: Texas
Study officials:
affiliation: University of Texas Southwestern Medical Center
name: Ank Nijhawan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beth Israel Deaconess Medical Center
name: Douglas Krakower, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01595919: A Comparison of Beverages Consumed Within a Meal to Satiation on Meal-time Food Intake and Post-meal Appetite and Glycemic Response in Healthy Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Hyperglycemia
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2012-05-10
Enrollment: 26
Sex: ALL
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The objective of the current study is to determine the effects of an ad libitum intake of 1% milk, fruit juice, regular cola, diet cola and water, as part of a pizza meal, on meal food intake, appetite and postprandial blood glucose in healthy men and women. We hypothesize that 1% milk will reduce food intake and result in better post-meal glycemic response compared to the other beverages.


Eligibility criteria: Inclusion Criteria:

* healthy men and women
* age 20-30 years
* BMI between 20-24.9 kg/m\^2

Exclusion Criteria:

* breakfast skippers
* diabetes or any metabolic diseases
* lactose intolerance or allergies to milk
* taking medications

Primary outcomes:
measure: Food Intake
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University of Toronto, Department of Nutritional Sciences
state: Ontario
Study officials:
References:
citation: El Khoury D, Panahi S, Luhovyy BL, Douglas Goff H, Harvey Anderson G. Interaction of mealtime ad libitum beverage and food intake with meal advancement in healthy young men and women. Physiol Behav. 2015 May 1;143:39-44. doi: 10.1016/j.physbeh.2015.02.023. Epub 2015 Feb 18.
Clinical trial NCT00783419: Rate of Pelvic Inflammatory Disease at St. Michael's Hospital
Official title: Rate of Pelvic Inflammatory Disease and Tubo-ovarian Abscess at SMH
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Inflammatory Disease
Keywords: tubo-ovarian abscess, pelvic-inflammatory disease
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2008-10-31
Enrollment: 55
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with pelvic-inflammatory disease or tubo-ovarian abscess

Brief summary: A retrospective review of women who came through the ER at SMH with a pelvic inflammatory disease (PID) or tubo-ovarian abscess (TOA) between 1995-2005. They were looking at people with this diagnosis to determine how they were treated, whether as inpatient or outpatient and whether they were treated with drugs and how were these given and also did they develop an abscess.


Eligibility criteria: Inclusion Criteria:

* women admitted to Emergency with pelvic-inflammatory disease or tubo-ovarian abscess from the year range: 1995-2000

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
affiliation: Unity Health Toronto
name: Mark Yudin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02619019: Effect of Spinal Dexamethasone During Transuretheral Prostatectomy
Official title: Intrathecal Dexamethasone in Patients Undergoing Transuretheral Prostatectomy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postspinal Shivering
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2015-12-02
Enrollment: 90
Sex: MALE
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Dexamethasone, a high-potency, long-acting glucocorticoid, when added to bupivacaine, it extended the duration of analgesia. We aim to study the effectiveness of spinal dexamethasone in Transuretheral prostatectomy.

Detailed description: Spinal anesthesia for endoscopic urology surgery like transurethral resection of the prostate is a well-established technique. Opioids are extensively used as an adjunct to local anesthetics in neuraxial blockade to enhance the duration of postoperative analgesia. However, worrisome adverse effects like pruritus, urinary retention, postoperative vomiting and respiratory depression limit its use. The aim of this study was to investigate the effectiveness of Intrathecal dexamethasone as adjunct to local anesthetics.

Eligibility criteria: Inclusion Criteria:

* Age: 50-75 yr ASA class I,II, and III undergoing Transuretheral prostatectomy under spinal anesthesia

Exclusion Criteria:

* Contraindications to spinal anesthesia, Allergy to the study medication, Thyroid disease, Parkinson's disease Patients receiving vasodilators or medications likely to alter thermoregulation.

Primary outcomes:
measure: Shivering
timeFrame: 150 min after spinal anesthesia
Secondary outcomes:
measure: Mean arterial blood pressure
timeFrame: 150 min after spinal anesthesia
measure: Heart rate
timeFrame: 150 min after spinal anesthesia
measure: Core temperature
timeFrame: 150 min after spinal anesthesia
Other outcomes:
Locations:
city: Asyut
country: Egypt
facility: Seham Mohamed Moeen Ibrahim
Study officials:
affiliation: Assiut Univerisity
name: Seham M Moeen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06201819: Liraglutide Effectiveness in Preoperative Weight-loss for Bariatric-metabolic Surgery
Official title: Liraglutide Effectiveness in Preoperative Weight-loss for Patients With Severe Obesity Undergoing Bariatric-metabolic Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Weight Loss
Bariatric Surgery Candidate
Obesity, Morbid
Keywords: Preoperative weight loss
Lead sponsor: Unidad de Cirugia Bariatrica Hospital Civil Dr. Juan I. Menchaca
Sponsor class: OTHER
First posted: 2024-01-11
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: quasi-experimental prospective before-and-after study.
Primary purpose: TREATMENT

Brief summary: Severe obesity is associated with considerable reduction of wellbeing and life expectancy. People living with severe obesity tend to die 8 to 10 years earlier. Preoperative management of patients living with severe obesity can be challenging and proper weight-loss may help obtain better outcomes and less morbidity. The effectiveness of GLP-1 analogue Liraglutide in preoperative weight-loss was evaluated in the study.

Detailed description: Objective:

Determine liraglutide effectiveness for preoperative weight-loss in patients with severe obesity undergoing bariatric-metabolic surgery.

Methods:

It is a single center, quasi-experimental prospective before-and-after study. All patients were assigned the same pharmacological treatment with liraglutide, initiating dosing with 0.6 mg per day escalating 0.6 mg every week up to 3.0 mg. The treatment dose was delivered once daily via subcutaneous injection for 3 months (12 weeks). Weight-loss and percentage weight-loss was evaluated monthly using bioelectric impedance (BIA) final result at week 12.

Eligibility criteria: Inclusion Criteria:

* Patients with BMI greater than 48 kg/m2 in pre-surgical protocol for bariatric surgery of the Bariatric and Metabolic Surgery Unit of the Civil Hospital of Guadalajara "Dr. Juan I. Menchaca

Exclusion Criteria:

* Patients under 18 years of age or over 65 years of age.

  * Pregnant patients.
  * Patients who do not agree to give their consent and take part in the study.
  * Patients with allergy to liraglutide, multiple endocrine neoplasia type 2 and medullary thyroid cancer, gallstones.

Removal:

* Patients who decide to abandon the study.
* Patients who do not follow the instructions or do not adhere to the treatment.

Primary outcomes:
measure: Preoperative weight changes
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Departamento de Cirugia Bariatrica y Metabolica del Hsopital Civil Dr. Juan I. Menchaca
state: Jalisco
Study officials:
References:
Clinical trial NCT07020819: An Open Label Clinical Study to Evaluate Tanruprubart (Also Commonly Known as ANX005) in Participants With Guillain-Barré Syndrome (FORWARD Study)
Official title: An Open-Label Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Efficacy, and Safety of a Single Dose of Tanruprubart (Also Commonly Known as ANX005) in Participants With Guillain-Barré Syndrome (GBS) (FORWARD Study)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Guillain-Barre Syndrome
Keywords: Guillain-Barre Syndrome
GBS
ANX005
Tanruprubart
FORWARD study
Lead sponsor: Annexon, Inc.
Sponsor class: INDUSTRY
First posted: 2025-06-13
Enrollment: 30
Sex: ALL
Minimum age (years): 12
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this open label study is to measure pharmacokinetics, pharmacodynamics, early efficacy, and safety of tanruprubart in adult and pediatric participants, in the United States, Canada, and Europe.


Eligibility criteria: Key Inclusion Criteria:

* Diagnosis of GBS according to the National Institute of Neurological Disorders and Stroke Diagnostic Criteria for GBS.
* Onset of GBS-related weakness ≤10 days before start of infusion on Day 1
* GBS-disability score (DS) score of 3, 4, or 5 at screening and before start of infusion on Day 1.

Key Exclusion Criteria:

* Previous or intended treatment with either plasma exchange or IV immunoglobulin for GBS.
* Diagnosis of a variant of GBS, including Miller Fisher syndrome, Bickerstaff's encephalitis, and overlap syndromes.

Other protocol-defined criteria may apply.

Primary outcomes:
measure: Area Under the Tanruprubart Serum Concentration-time Curve to the Last Sample (AUC0-t)
timeFrame: Up to Day 15
measure: Observed Time to Maximum Observed Serum Concentration (Cmax) (Tmax) of Tanruprubart
timeFrame: Up to Day 15
Secondary outcomes:
measure: Change From Baseline in Free Component of Complement Complex (C1q) Protein Concentration in Serum
timeFrame: Baseline up to Day 15
measure: Change from Baseline in Medical Research Council (MRC) Sumscore at Week 1
timeFrame: Baseline, Week 1
Other outcomes:
Locations:
Study officials:
affiliation: Annexon, Inc.
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT05948319: the Fetal Epicardial Thickness in Obese Pregnant Women (EFT)
Official title: The Effect of Myocardial Performance Index and Fetal Epicardial Thickness on Perinatal Outcomes in Obese Pregnant Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fetus Fetus
Pregnancy Complications
Keywords: obesity,
fetal epicardial thickness
myocardial performance index
perinatal outcome
Lead sponsor: Necmettin Erbakan University
Sponsor class: OTHER
First posted: 2023-07-17
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: case control
Primary purpose: SCREENING

Brief summary: the effects of fetal EFT on fetal cardiac function and fetal and maternal outcomes were investigated in obese pregnant women compared with normal-weight pregnant women.

Detailed description: All pregnant women underwent a comprehensive fetal anomaly screening. One obstetrician (S.D.) assessed all of the measurements. Every measurement was performed using a convex 2-5 MHz Voluson E8 probe (GE Healthcare, Milwaukee, WI). Fetal biometry, UA, MCA Doppler, cerebroplacental ratio (CPR), modified MPI (mod-MPI), and EFT were assessed in accordance with the International Society of Ultrasound in Obstetrics and Gynecology (ISUOG) guidelines

Eligibility criteria: Inclusion Criteria:

* Obese pregnant women
* normal-weight pregnant women
* 24-40 gestational week

Exclusion Criteria:

Twin pregnancies, structural and chromosomal abnormalities, fetal rhesus isoimmunization, fetal growth restriction, cases with infections detected by maternal serological tests, pregestational or gestational diabetes (All patients underwent a 75-gram glucose load test at 24 weeks to rule out diabetes), preeclampsia, premature rupture of membranes were excluded from the study -

Primary outcomes:
measure: birth weight (gram)
timeFrame: birth 1 week
measure: stillbirth rate (%)
timeFrame: birth 1 week
measure: NICU admission
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Necmettin Erbakan University
Study officials:
affiliation: NECMETTİN ERBAKAN UNIVERCITY
name: şükran DR doğru, md
role: STUDY_DIRECTOR
affiliation: NECMETTİN ERBAKAN UNIVERCITY
name: fatih dr akkuş, md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01750619: Clinical Outcomes of the Endoscopic Resection of Premalignant and Malignant Gastrointestinal Lesions
Official title: Clinical Outcomes of the Endoscopic Resection of Premalignant and Malignant Gastrointestinal Lesions
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gastrointestinal Neoplasms
Benign Neoplasm of Intestinal Tract
Lead sponsor: California Pacific Medical Center Research Institute
Sponsor class: OTHER
First posted: 2012-12-17
Enrollment: 4000
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: Patients referred to Interventional Endoscopy Services at CPMC for treatment of GI tract tumors.

Brief summary: To evaluate clinical outcome for patients receiving treatment of suspected premalignant and malignant gastrointestinal lesions at Interventional Endoscopy Services. The primary outcome is curative endoscopic resection. Secondary outcomes include resection technique utilized, rates of en bloc resection and adverse event rates, including infection, bleeding, perforation and death, and one-year survival rates.


Eligibility criteria: Inclusion Criteria:

* Patients age \>18 years that have been referred for endoscopic treatment of GI lesions.

Exclusion Criteria:

* Patients for whom endoscopic treatment was not performed.

Primary outcomes:
measure: Technical success.
timeFrame: 1 day to 3 months
Secondary outcomes:
measure: Short term recurrence rate
timeFrame: Less than 1 year
measure: Long term recurrence rate
timeFrame: Greater than 1 year
measure: Adverse event rate
timeFrame: up to 1 month post procedure.
measure: Endoscopic en bloc resection rate
timeFrame: Immediate
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Interventional Endoscopy Services
state: California
Study officials:
affiliation: California Pacific Medical Center
name: Kenneth F Binmoeller, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Binmoeller KF, Hamerski CM, Shah JN, Bhat YM, Kane SD. Underwater EMR of adenomas of the appendiceal orifice (with video). Gastrointest Endosc. 2016 Mar;83(3):638-42. doi: 10.1016/j.gie.2015.08.079. Epub 2015 Sep 14.
citation: Binmoeller KF, Hamerski CM, Shah JN, Bhat YM, Kane SD, Garcia-Kennedy R. Attempted underwater en bloc resection for large (2-4 cm) colorectal laterally spreading tumors (with video). Gastrointest Endosc. 2015 Mar;81(3):713-8. doi: 10.1016/j.gie.2014.10.044.