louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01231698: Heart Rate Control With Esmolol in Septic Shock
Official title: Strict Heart Rate Control With Esmolol in Septic Shock: a Randomized, Controlled, Clinical Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Septic Shock
Keywords: septic shock
esmolol
tachycardia
betablockers
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2010-11-01
Enrollment: 154
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: The purpose of this study is investigate the effects on systemic hemodynamics and organ function of esmolol when used to maintain heart rate below a predefined threshold in patients with septic shock.

Detailed description: 154 septic shock patients with heart rate \> of 95 bpm and requiring vasopressor support to maintain mean arterial pressure between 65 and 75 mmHg despite adequate volume resuscitation, will be enrolled in the study. Patients will be randomly allocated to be treated with either a) a continuous esmolol infusion at any doses to maintain heart rate between 95 and 80 bpm b)to a standard treatment without heart rate control(control; each n = 77). In both groups, norepinephrine will be titrated to achieve a mean arterial pressure (MAP) between 65 and 75 mmHg. Data from right heart catheterization,data from organ function as well as norepinephrine requirements will be obtained at baseline and after 24, 48, 72, and 96 hours. The protocol will require that esmolol be infused continuously at any doses to maintain the predefined heart rate threshold until one the following events occur: the patient die, a serious adverse effect attributed to the study drug infusion, or the patient has been discharged from ICU.

Eligibility criteria: Inclusion Criteria:

* septic shock criteria
* presence of heart rate \> 95 bpm.

Exclusion Criteria:

* Pregnancy
* age \< 18

Primary outcomes:
measure: heart rate
timeFrame: over a period of 96 hrs
Secondary outcomes:
measure: systemic hemodynamics
timeFrame: over a period of 96 hours
Other outcomes:
measure: ICU Mortality
timeFrame: 28 days
Locations:
city: Rome
country: Italy
facility: Department of Anesthesiology and Intensive care of the University of Rome La Sapienza
Study officials:
affiliation: University of Roma La Sapienza
name: Andrea Morelli, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Morelli A, Ertmer C, Westphal M, Rehberg S, Kampmeier T, Ligges S, Orecchioni A, D'Egidio A, D'Ippoliti F, Raffone C, Venditti M, Guarracino F, Girardis M, Tritapepe L, Pietropaoli P, Mebazaa A, Singer M. Effect of heart rate control with esmolol on hemodynamic and clinical outcomes in patients with septic shock: a randomized clinical trial. JAMA. 2013 Oct 23;310(16):1683-91. doi: 10.1001/jama.2013.278477.
Clinical trial NCT03253198: Prospective RCT Comparing Perioperative Pain
Official title: Preoperative Interscalene Nerve Block Plus Postoperative Local Intra-operative Analgesic Injection vs Preoperative Interscalene Nerve Block Plus Postoperative Saline Injection in Patients Undergoing Shoulder Arthroplasty: a Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthroplasty Shoulder
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
First posted: 2017-08-17
Enrollment: 156
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: This study is a non-blinded randomized controlled trial comparing the use of a preoperative "mini" block plus postoperative local infiltration of Exparel (liposomal form of bupivacaine) versus a partial single shot nerve block in subjects undergoing primary reverse or total shoulder arthroplasty to see which is more effective in controlling surgery related pain. To do so, we will utilize the Visual Analog Scale (VAS) to measure pain intensity. Opioid consumption will be recorded on a Pain Monitoring Sheet.


Eligibility criteria: Inclusion Criteria:

* All individuals undergoing primary reverse and total shoulder arthroplasty by the shoulder service at Thomas Jefferson University Hospital, Methodist Hospital or Rothman Specialty Hospital.

Exclusion Criteria:

* Psychiatric illness as defined by co-morbid diagnosis of bipolar disorder or schizophrenia
* Revision arthroplasty or arthroplasty for fracture
* Unable/unwilling to consent for enrollment
* Unable to complete postoperative pain survey
* Known adverse drug reaction or allergy to the medications used
* Chronic pain syndromes (including reflex sympathetic dystrophy, fibromyalgia, chronic diffuse musculoskeletal pain)
* Patients taking long acting opioid pain medications (including extended release opioid pain medications and methadone)
* Patients under the age of 18 years
* Patients with history of hepatic disease
* Pregnant or breastfeeding women.

Primary outcomes:
measure: morphine and morphine equivalent consumption
timeFrame: 24 hours post surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Rothman Institute
state: Pennsylvania
Study officials:
affiliation: Rothman Institute
name: Surena Namdari, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06838598: Structural and Microbiological Characterization of Arterial Catheter Biofilm in ICU's Patients Using Optical Coherence Tomography
Official title: Structural and Microbiological Characterization of Arterial Catheter Biofilm in ICU's Patients Using Optical Coherence Tomography
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Biofilms
Arterial Catheterization, Peripheral
Bacteremia
Tomography, Optical Coherence
Lead sponsor: Centre Hospitalier William Morey - Chalon sur Saône
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Universitaire Dijon
name: Centre Hospitalier Macon
First posted: 2025-02-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient over 18 years of age with artherial catheter more than 2 calendar days

Brief summary: 29.3% of bacteremias in intensive care units (ICU) are linked to vascular devices, including 7.7% to arterial catheters, with an influence on both morbility and mortality.

It is now accepted that biofilm as a role on bacterial development on inner surface of vascular devices but there is yet a lack of clinical relevant data documenting a causal relation between biofilm formation and bacteremias.

The investigators assume that a better structural and microbiological characterization of arterial catheter biofilm in ICU patients could help preventing bacteremias or have a more specific treatment when it appears.


Eligibility criteria: Inclusion Criteria:

* Patient or relative informed of the study and having declared their non-objection
* Patient over 18 years old
* Patient hospitalized in ICU with an arterial catheter

Exclusion Criteria:

* Patient unable to express consent
* Patient whose collection of the arterial catheter is impossible or for whom storage at 4°C is impossible
* Patient with arterial catheter removed outside the usual procedure of the ICU
* Patient admitted in ICU with an arterial catheter already in place

Primary outcomes:
measure: Biofilm structure type (ribbon-shaped or mushroom-shaped), measured with D-FF-OCT
timeFrame: Outcome measure is assessed 2 days following catheter removal
Secondary outcomes:
measure: Bacterial or fungal indentification
timeFrame: Outcome measure is assessed 2 days following catheter removal
measure: Biofilm thickness, measured with D-FF-OCT
timeFrame: Outcome measure is assessed 2 days following catheter removal
measure: Biofilm dynamic signal distribution, measured with D-FF-OCT
timeFrame: Outcome measure is assessed 2 days following catheter removal
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon Bourgogne
state: Bourgogne
city: Mâcon
country: France
facility: CH Macon
state: Bourgogne
Study officials:
References:
Clinical trial NCT05753098: Effect of Sildenafil Citrate Compared to Estrogen as Adjuvant Therapy for Unexplained Infertility
Official title: Effect of Sildenafil Citrate Compared to Estrogen as Adjuvant Therapy on Improvement of Endometrial Thickness and Treatment of Unexplained Infertility
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Subfertility, Female
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2023-03-03
Enrollment: 148
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: . This study aimed to determine and compare the effect of vaginal sildenafil citrate and estradiol valerate on endometrial thickness, blood flow and pregnancy rates in infertile women.

Detailed description: The study is a randomized controlled trial that was carried on 148 infertile women with unexplained infertility. Patients were divided into 3 groups. Group 1 included 48 patients who received oral estradiol valerate (Cyclo-Progynova 2mg, from day 8th till triggering of ovulation), another 50 patients in group 2 received oral Sildenafil (Respatio 20mg/12hr film coated tablets for 5 days starting from last day of menstruation till ovulation), while group 3 was the control one who included 50 patients were given ovulation induction with CC 50mg/12hr from 2nd to 7th day of cycle. Every patient underwent a transvaginal ultrasound to determine ovulation, number of follicles, and pregnancy rates. Miscarriage, ectopic pregnancy, and multiple pregnancies were tracked for 3 months, as were any adverse consequences.

Eligibility criteria: Inclusion Criteria:

* aged between 18 to 40 years
* unexplained infertility (primary or secondary)
* had a regular menstrual cycle;
* patent tubes;
* husbands with normal semen parameters.

Exclusion Criteria:

* hypotension;
* cardiovascular, hepatic, and renal diseases;
* uncontrolled diabetes mellitus;
* anovulatory infertility;
* ovarian cysts;
* pelvic adhesions;
* hyperprolactinemia;
* abnormal thyroid functions;
* multiple uterine fibroids;
* patients on nitrates;
* suspicion of endometriosis and adenomyosis,
* subjects have known to receive any treatment for fertility in the last six months

Primary outcomes:
measure: pregnancy rates
timeFrame: at the end of each of 3 cycles (28 days)
Secondary outcomes:
measure: ovulation
timeFrame: 3 months
Other outcomes:
Locations:
city: Banī Suwayf
country: Egypt
facility: Beni-suef university
Study officials:
affiliation: Clinical Pharmacy Faculty of Pharmacy Beni-Suef University
name: Beni-Suef University
role: STUDY_DIRECTOR
References:
Clinical trial NCT02792998: A Trial of IW-1701, A Stimulator of Soluble Guanylate Cyclase (sGC), in Healthy Subjects
Official title: A 2-Stage Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IW-1701 Tablets in Healthy Subjects in a Double-blind, Placebo-controlled, Multiple-ascending-dose Stage and an Open-label, Single-dose, Crossover Food-effect Stage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Cyclerion Therapeutics
Sponsor class: INDUSTRY
First posted: 2016-06-08
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objectives of this study are:

Stage 1: To assess the safety, tolerability, pharmacokinetic (PK) profile and pharmacodynamic (PD) effects of a range of doses of IW-1701 tablets administered orally to healthy subjects over 7 days of repeated dosing

Stage 2: To assess the safety, tolerability, PK profile and PD effects of IW-1701 tablets administered orally to healthy subjects, in fed and fasted states, in an open-label, single-dose, 2-period, 2-sequence crossover study.


Eligibility criteria: Inclusion Criteria:

* Subject is an ambulatory male or female between 18 and 55 years old at the screening visit
* Subject's body mass index score is \> 18.5 and \< 30.0 kg/m2 at the screening visit
* Women of childbearing potential must have a negative pregnancy test at the time of check-in and must agree to use double-barrier contraception throughout the duration of the study
* Subject is in good health and has no clinically significant findings on a physical examination
* Other inclusion criteria per protocol

Exclusion Criteria:

* History of any clinically significant medical conditions
* Other exclusion criteria per protocol

Primary outcomes:
measure: Treatment Emergent Adverse Event
timeFrame: 47 Days
measure: Maximum observed plasma concentration [Cmax]
timeFrame: 47 Days
measure: Area under the plasma concentration time curve during a dosing interval [AUC]
timeFrame: 47 Days
measure: Time of maximum observed plasma concentration [Tmax]
timeFrame: 47 Days
measure: Blood Pressure
timeFrame: 47 Days
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: ICON Early Phase Unit
state: Texas
Study officials:
References:
Clinical trial NCT06661798: Evaluation of the Mental Foramen After Surgery Via Ultrasonography
Official title: Evaluation of Changes in Mental Foramen Blood Flow After Orthognathic Surgery Using Ultrasound
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthognathic Surgery
Keywords: Mental foramen
orthognathic surgery
blood flow
ultrasonography
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2024-10-28
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Objective: This study aims to detect changes in blood flow in the mental foramen after surgery compared to before orthognathic surgery.

Materials and Methods: This study will include a total of 16 patients, aged between 18-60, who were planned for orthognathic surgery due to malocclusion complaints. Patients will be evaluated clinically and radiologically before surgery, 1 week, 1 month, and 3 months after the surgery. Panoramic radiographs will be taken before surgery and 3 months after surgery, and a fractal analysis of the ROI area determined distal to the mental foramen will be performed. Pain will be scored from 1 to 5 using the Pinprick test before surgery, 1 week, 1 month, and 3 months after surgery, while pressure and neurosensitivity will be scored using VAS. Neurosensory evaluation will be performed using two-point discrimination (dividing the area between the lower lip and chin into 9 regions), and left-right discrimination will be checked using the brush test. Blood flow in the mental foramen will be evaluated using ultrasonography.


Eligibility criteria: Inclusion Criteria:

1. Patients over 18 years old,
2. Patients who have reached skeletal maturity,
3. Patients under 60 years old,
4. Patients with skeletal Class II malocclusion indicated for orthognathic surgery,
5. Patients with skeletal Class III malocclusion indicated for orthognathic surgery,
6. Those who are willing to participate in the study

Exclusion Criteria:

1. Patients with cleft lip and palate,
2. Patients with craniofacial anomalies,
3. Patients with a systemic disease,
4. Patients under 18 years old,
5. Patients who have not completed their growth and development,
6. Patients over 59 years old,
7. Patients using neurological and psychiatric medications,
8. Patients who have previously undergone surgery or experienced trauma in the mandibular region,
9. Patients with neurosensory dysfunction in the inferior alveolar nerve before surgery,
10. Pregnant individuals or those suspected of being pregnant,
11. Any local or systemic condition that may contraindicate general anesthesia

Primary outcomes:
measure: Changes in blood flow in the mental foramen after orthognathic surgery
timeFrame: From enrollment to 3 months after the end of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakif University
state: Fatih
Study officials:
References:
Clinical trial NCT00160498: Testing the Efficacy of Different Dosages of Lercanidipine to Reduce Hypertensive Blood Pressure in Normal Weight and Obese Patients
Official title: A Double-Blind, Randomized, Multicenter, Placebo-Controlled, Parallel, Dose-Titration Study to Assess the Efficacy of Lercanidipine 10 mg and 20 mg Once Daily p. o. in Hypertensive Subjects (I or II WHO) With Elevated Body Weight.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Lercanidipine, calcium antagonist, hypertension, obesity
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: A double blind study to examine the safety and efficacy of different dosages of lercanidipine in normal weight and obese patients with hypertension


Eligibility criteria: Inclusion Criteria:

* Body Mass Index (BMI): 18.0 - 24.9 or 30.0 - 39.9 kg/m2 (extremes included);
* Essential hypertension I or II WHO:
* 140 mmHg ≤ BPs ≤ 179 mmHg and BPd ≤ 109 mmHg at the end of the placebo run-in phase;

Exclusion Criteria:

* Secondary hypertension;
* Diabetes mellitus type 1, insulin dependent diabetes mellitus type 2, fasting blood glucose ≥ 160 mg/dl;
* Subjects keeping to a hypocaloric diet (except special diet for diabetics) to reduce body weight;
* History or presence of angioneurotic oedema;
* Subjects developing a hypertensive crisis during wash-out or placebo run-in period;

Primary outcomes:
measure: change from baseline of systolic blood pressure (BPs) after 4 weeks of treatment
Secondary outcomes:
measure: Blood pressure, response rate, normalization rate, pulse rate, lipid profile, safety and tolerability. Measures after 4, 8, 12 weeks.
Other outcomes:
Locations:
Study officials:
affiliation: UCB Pharma
name: Jürgen Scholze, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05494398: Targeting the Neurobiology of RRB in Autism Using N-acetylcysteine: Open Label
Official title: Targeting the Neurobiology of Restricted and Repetitive Behaviors in Children With Autism Using N-acetylcysteine: an Open Label Extension
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE2
PHASE3
Conditions: Autism Spectrum Disorder
Keywords: Magnetic Resonance Imaging
N-acetylcysteine
Restricted and Repetitive Behaviors
Electroencephalography
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2022-08-10
Enrollment: 48
Sex: ALL
Minimum age (years): 3
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this study is to target the neurobiology of restricted and repetitive behaviors in children with autism spectrum disorder using N-acetylcysteine (NAC), a well-tolerated nutritional supplement that has shown promise for reducing symptom severity in recent small-scale trials. The findings from this research will shed light on the mechanisms of action underlying the clinical benefits of NAC and the effects of NAC on altering restricted and repetitive behavior symptom severity in children with autism spectrum disorder.


Eligibility criteria: Inclusion Criteria:

* participation in an associated single-dose (IRB-54931, NCT04278898) or randomized, controlled trial of NAC (IRB-63262, NCT05664789).
* stable medication regimens (≥ 30 days) with no anticipated changes during the trial.

Exclusion criteria:

• the presence of significant medical problems that reduce medical stability.

Primary outcomes:
measure: Change in glutamatergic neurometabolites (Glx) measured by proton spectroscopy Magnetic Resonance Imaging (MRI)
timeFrame: Baseline and Week 12 of treatment
measure: Change in restricted and repetitive behaviors as measured by Children's Yale Brown Obsessive Compulsive Scale - Autism Spectrum Disorder (CYBOCS-ASD)
timeFrame: Screening, Week 8, week 12
Secondary outcomes:
measure: Change in Gamma band amplitude and synchronization measured by electroencephalography (EEG)
timeFrame: Baseline, Week 12
measure: Change in restricted repetitive behavior subtypes as measured by the Restricted Behavior Scale - Revised (RBS-R)
timeFrame: Baseline, week 8, week 12
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: John Hegarty, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01773798: A Trial Investigating the Pharmacodynamic and Pharmacokinetic Properties of Insulin Degludec/Insulin Aspart 15 in Subjects With Type 1 Diabetes
Official title: A Trial Investigating the Pharmacodynamic and Pharmacokinetic Properties of Insulin Degludec/Insulin Aspart 15 in Subjects With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 1
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2013-01-23
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of the trial is to investigate the pharmacodynamic (the effect of the investigated drug on the body) and the pharmacokinetic (exposure of the trial drug in the body) properties of insulin degludec/insulin aspart 15 in subjects with type 1 diabetes.


Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
* Body mass index 18.0-28.0 kg/m\^2 (both inclusive)

Exclusion Criteria:

* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
* Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
* Not able or willing to refrain from smoking, use of nicotine substitute products or transdermal nicotine patches during the inpatient period
* Female of childbearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods (adequate contraceptive measures include sterilisation, hormonal intrauterine devices, oral contraceptives, condom with spermizide, sexual abstinence or vasectomised partner)

Primary outcomes:
measure: Area under the glucose infusion rate curve
timeFrame: From 0 to 6 hours after single dose (IDegAsp 15, IDeg and IDegAsp)
Secondary outcomes:
measure: Area under the serum IDeg concentration-time curve
timeFrame: From 0 to 120 hours after single dose
measure: Area under the serum IAsp concentration-time curve
timeFrame: From 0 to 12 hours after single dose
Other outcomes:
Locations:
city: Graz
country: Austria
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: