louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05367336: Platelet Reactivity With Fentanyl, Morphine, or no Narcotic
Official title: A Comparison of PLAtelet Response to Aspirin Between Emergency Department Patients With Chest Pain Receiving Fentanyl or Morphine (PLAAFM)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Fentanyl
Platelet Reactivity
Lead sponsor: Spectrum Health - Lakeland
Sponsor class: OTHER
First posted: 2022-05-10
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal is to determine whether fentanyl and morphine have similar effects in reducing aspirin's effect upon platelets in emergency department patients with chest discomfort. Morphine has been shown to worsen outcomes in heart attack patients due to reduction of oral anti-platelet agent effectiveness and so many providers have switches to using fentanyl. However, it is largely unknown whether fentanyl has similar effects.

Detailed description: Patients presenting to the emergency department with chest discomfort who are being administered aspirin will be offered enrollment in this study. At the time of their zero and two hour troponin we will also draw platelet aggregration studies to determine the effects of aspirin upon platelets. Narcotic medicines slow the absorption of aspirin. Morphine has therefore been shown to decrease the effectiveness of aspirin. Many providers therefore use fentanyl instead, however little is known about the effects of fentanyl upon aspirin. We will therefore compare the platelet reactivity of patients receiving morphine, fentanyl, or no narcotics

Eligibility criteria: Inclusion Criteria:

* Adult Emergency Department patients undergoing 0 and 2 hour troponin testing
* administered aspirin within 30 minutes of the initial blood draw.
* patient presented via private vehicle
* provide informed consent
* over the age of 18

Exclusion Criteria:

* Patients not expected to get a 2 hour troponin;
* patients already on aspirin, clopidogrel, or stronger anti-coagulants;
* patients who arrived via EMS (Emergency Medical Services) given it can be difficult to find the run reports to determine whether patient received fentanyl in the pre-hospital period;
* pregnant patients;
* patients on chronic narcotics;
* patients already once enrolled in this study,
* inability to provide consent in English

Primary outcomes:
measure: Baseline Arachidonic Acid Maximum Aggregation (%) Result
timeFrame: Baseline
measure: 2 Hour Arachidonic Acid Maximum Aggregation (%) Result
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Joseph
country: United States
facility: Spectrum Health Lakeland
state: Michigan
Study officials:
References:
Clinical trial NCT06482736: Effect Of Extracorporeal Shockwave Therapy on Tension-Type Headache in Adolescent Females
Official title: Effect Of Extracorporeal Shockwave Therapy on Tension-Type Headache in Adolescent Females
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tension-Type Headache
Lead sponsor: October 6 University
Sponsor class: OTHER
First posted: 2024-07-01
Enrollment: 40
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chronic headaches in adolescents can have consequences such as absence from school, inability to maintain social activities, and additional disorders such as anxiety, depression, problems sleeping, and reduced quality of life to investigates the efficacy shock wave diathermy on tension headaches in adolescent females

Detailed description: The prevalence of headaches increases with age, with a prevalence of 82% during adolescence. Extracorporeal Shockwave Therapy could reduce the pain of myofascial pain syndrome by pain signal alteration, promoting angiogenesis and increasing perfusion in ischemic tissues induced by sensitization of nociceptors and muscle ischemia

Eligibility criteria: Inclusion Criteria:

* Suffering from chronic tension headache (headaches occur 15 or more days a month for at least three months).
* Their age will range from 15 to 18 years.
* Having a sedentary lifestyle (A weekly physical activity of \< 600 MET-minutes/ week in the international physical activity questionnaire)
* Having regular menstruation (28 to 34 days).

Exclusion Criteria:

* Using oral contraceptives or
* any hormonal treatment in the previous six months.

Primary outcomes:
measure: digital algometer
timeFrame: The evaluation took place before and after 8 treatment visits using the positional inhibition technique. The treatment was carried out for 4 weeks, 2x a week, lasting 45 to 60 minutes each session.
measure: Electromyography (EMG) for neck muscles
timeFrame: The evaluation took place before and after 8 treatment visits using the positional inhibition technique. The treatment was carried out for 4 weeks, 2x a week, lasting 45 to 60 minutes each session.
measure: Headache impact test questionnaire
timeFrame: The treatment was carried out for 4 weeks, 2x a week, lasting 45 to 60 minutes each session.
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kerolous Ishak Shehata Kelini
Study officials:
affiliation: Cairo University
name: Kerolous IS kelini
role: STUDY_DIRECTOR
References:
Clinical trial NCT01529736: Randomized Study of Integration Success of Osseotite Dental Implants Placed Using Different Insertion Procedures
Official title: Prospective Randomized-controlled Study of the Integration Success of Osseotite Implants Placed With Different Insertion Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Partial Edentulism
Tooth Disease
Keywords: edentulism
dental implants
early loading
crestal bone level
high torque insertion
low torque insertion
randomized
Osseotite
clinical study
Lead sponsor: ZimVie
Sponsor class: INDUSTRY
First posted: 2012-02-09
Enrollment: 60
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: Osseotite implants placed with higher insertion torque (TEST procedure) will have higher initial stability and integration success than those placed with lower insertion torque forces.

Detailed description: Osseotite implants will be placed using the standard lower insertion torque forces and compared to implants placed using higher insertion torque forces.

Eligibility criteria: Inclusion Criteria:

* patients of either sex and older than 18 years of age
* patients needing a minimum of 3 implants to treat partial edentulism
* patients physically able to tolerate surgical and restorative dental procedures
* patients agreeing to all protocol visits

Exclusion Criteria:

* patients with infection or severe inflammation at the intended treatment sites
* patients smoking greater than 10 cigarettes per day
* patients with uncontrolled diabetes mellitus
* patients with uncontrolled metabolic diseases
* patients who received radiation treatment to the head in the past 12 months
* patients needing bone grafting at the intended treatment sites
* patients known to be pregnant at screening visit
* patients with para-functional habits like bruxing and clenching

Primary outcomes:
measure: primary stability countertorque measures
timeFrame: 4 months
Secondary outcomes:
measure: cumulative success rate
timeFrame: 1 year
Other outcomes:
Locations:
city: Bogota
country: Colombia
facility: Universidad Javeriana
Study officials:
affiliation: Universidad Javeriana
name: Armando Estefan, DMD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01609036: An Observational Study of MabThera/Rituxan (Rituximab) in Patients With Follicular Lymphoma
Official title: An Observational Phase IV Non Interventional Study in Patients With Advanced Follicular Lymphoma (III-IV) Evaluating the Safety of Maintenance Therapy With Rituximab After 8 Cycles of Rituximab in Combination With Chemotherapy as Induction Therapy in Previously Untreated Patients in Greece.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Lymphoma, Follicular
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-05-31
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with stage III-IV follicular lymphoma

Brief summary: This observational study will evaluate the safety and efficacy of MabThera/Rituxan (rituximab) in previously untreated patients with follicular lymphoma. Data will be collected for 3 years


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/=18 years
* Patients with previously untreated follicular lymphoma (stage III-IV) according to the approved summary of product characteristics (SPC)

Exclusion Criteria:

* Contraindications to MabThera/Rituxan therapy according to the approved SPC

Primary outcomes:
measure: Safety: Incidence of adverse events
timeFrame: 3 years
Secondary outcomes:
measure: Progression-free survival
timeFrame: 3 years
measure: Event-free survival
timeFrame: 3 years
measure: Overall survival
timeFrame: 3 years
Other outcomes:
Locations:
city: Athens
country: Greece
city: Athens
country: Greece
city: Patras
country: Greece
city: Thessaloniki
country: Greece
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02781636: Protect Chronic Tibial Nerve Stimulator (CTNS) System
Official title: A European Trial to Assess the Efficacy of an Implantable Wireless Neuromodulation Device at the Tibial Nerve to Treat Urinary Urgency Incontinence
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Urge Incontinence
Keywords: Efficacy
Implantable
Wireless
Neuromodulation
Device
Tibial
Lead sponsor: Uro Medical Corporation
Sponsor class: INDUSTRY
First posted: 2016-05-24
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 30 patient Study. All patients implanted with StimGuard Protect System. Patient followed out to 90 days.

Detailed description: The proposed therapy is called chronic tibial nerve stimulation (CTNS), which is a low-risk, minimally invasive chronic implant for the treatment of urgency urinary incontinence. CTNS works by the same mechanism as percutaneous tibial nerve stimulation (PTNS), but is provided for chronic use with an implantable device. CTNS treatment involves the placement of a minimally invasive stimulator with an embedded receiver at the tibial nerve. The Protect CTNS System has an external transmitter that activates the implanted stimulator and sends mild electrical pulses to the tibial nerve. These impulses travel to the sacral nerve plexus, the group of nerves at the base of the spine responsible for bladder function. Since stimulation with the Protect CTNS System is chronic it is expected that bladder activity can be changed more quickly and without the frequency of treatments related to PTNS.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of overactive bladder with urgency urinary incontinence

Exclusion Criteria:

* Primary complaint of stress urinary incontinence

Primary outcomes:
measure: Reduction in Urge Incontinence Episodes
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: UZA
Study officials:
References:
Clinical trial NCT01081236: Intestinal Barrier Function and Liver Cirrhosis
Official title: The Role of the Intestinal Barrier Function in Liver Cirrhosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Cirrhosis
Keywords: liver cirrhosis
intestinal permeability
microbiota
complications
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2010-03-05
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be selected from a hospital providing both secondary and tertiary care

Brief summary: Patients with liver cirrhosis have an increased risk to develop life-threatening complications such as spontaneous bacterial peritonitis (SBP). Impairment in the intestinal barrier, changes in numbers and composition of the intestinal microbiota and alterations in immune defenses have been suggested to be involved in liver cirrhosis and its complications. Dysfunction in the intestinal barrier for example results in the ongoing passage of toxic substances from the gastrointestinal tract that may damage the liver, leading to oxidative stress, inflammation and eventually liver cirrhosis. In addition, bacterial translocation is considered a key step in the development of spontaneous infections, mainly SBP, in patients with liver cirrhosis.

The investigators hypothesize that patients with decompensated liver cirrhosis have a more impaired intestinal epithelial barrier and altered intestinal microbiota than patients with compensated liver cirrhosis.


Eligibility criteria: Inclusion Criteria:

* Liver cirrhosis of any cause
* A score of greater-than or equal to 5 assessed according to the Child-Pugh classification
* Age between 18 and 65 years

Exclusion Criteria:

* Known gastrointestinal diseases (such as inflammatory bowel disease and celiac disease), chronic renal disease (i.e. a glomerular filtration rate of less-than or equal to 60 ml/min per 173 m2 estimated from the Modification of Diet in Renal Disease (MDRD) equation) or Diabetes Mellitus
* Major abdominal surgery interfering with gastrointestinal function (except for uncomplicated appendectomy, cholecystectomy and hysterectomy, other surgery upon judgement of the principle investigator)

Primary outcomes:
measure: The primary aim is to study differences in small and large intestinal permeability between patients with compensated and decompensated cirrhosis by means of a sugar permeability test
timeFrame: 2 years
Secondary outcomes:
measure: To assess tight junction structure and proteins in biopsy specimens of small and large intestine
timeFrame: 2 years
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: Limburg
Study officials:
affiliation: Maastricht University Medical Center
name: A Masclee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01449136: Use of Antibacterial Cement in Infected Dentin
Official title: Phase 1 Study of Clinical and Radiographic Success of Antibacterial Cement in Infected Dentin of Deciduous Teeth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Keywords: Antibacterial agents
Deciduous Teeth
Clinical Trial
Lead sponsor: University of Pernambuco
Sponsor class: OTHER
First posted: 2011-10-10
Enrollment: 45
Sex: ALL
Minimum age (years): 5
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Dental materials with antibacterial properties can prevent the harmful effects caused by oral cariogenic bacteria. This double-blind controlled clinical trial evaluated the performance of antibacterial cement for sealing infected dentin in atraumatic restorations of primary molars.

Detailed description: The study enrolled 45 children (45 teeth) between 5 and 8 years of age, of both genders, divided into two groups. In group A (GA; n=22), the cavities were lined with conventional glass ionomer cement (Vidrion F®) and in group B (GB; n=23), with antibacterial cement (Vidrion F® containing 1% each of metronidazole, ciprofloxacin, and cefaclor). Both groups were restored with Ketac Molar Easymix®. Molars with carious lesions on the inner half of dentin without clinical or radiographic pulp damage were selected. Patients were evaluated clinically (for pain, fistulas, or mobility) and radiographically (area of caries, periapical region, and furcation of teeth) after 1, 3, 6, and 12 months.

Eligibility criteria: Inclusion Criteria:

* signed consent from a parent or guardian;
* primary molars with carious lesions on the inner half of dentin;
* access of caries lesions to dentin spoons.

Exclusion Criteria:

* damaged pulp determined clinically (for pain, fistulas, tooth mobility);
* damaged pulp determined radiography (bone or dental pathology);
* children taking antibiotics;
* children who refused the treatment;
* children had systemic disease.

Primary outcomes:
measure: number of successful restorations with a dental liner with antibiotics
timeFrame: differences of overall success between baseline and the evaluations performed at 1, 3, 6, and 12 months.
Secondary outcomes:
Other outcomes:
Locations:
city: João Pessoa
country: Brazil
facility: UFPB
state: PB
Study officials:
References:
citation: Ferreira JM, Pinheiro SL, Sampaio FC, Menezes VA. Use of glass ionomer cement containing antibiotics to seal off infected dentin: a randomized clinical trial. Braz Dent J. 2013;24(1):68-73. doi: 10.1590/0103-6440201301925.
Clinical trial NCT04690036: PD-1 Antibody for Reactive EBV After BMT
Official title: Reactivation of EBV for Patients With CAEBV and EBV Associated HLH After Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: PD-1
EBV Infection
Transplant
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2020-12-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: PD-1 antibody for reactivation of EBV after transplantation in patients with CAEBV/EBV-HLH

Detailed description: Transplantaion is recongnized as a cure for CAEBV and EBV associated HLH，however, many patients undergo the reactivation of EBV after transpaltion, patiens may at high risk for recurrence of the disease. PD-1 is a promising therapy to solve this problem.

The present study was a one-arm clinical study, the main subject is to evaluate the effect of PD-1 antibody on the clearance of EBV

Eligibility criteria: Inclusion Criteria:

1. Meet hemophagocytic lymphohistiocytosis (HLH)-04 diagnostic criteria; EBV-DNA in peripheral blood or EBER in tissue were positive, patients were diagnosed with EBV associated HLH (EBV-HLH). Chronic active EBV infection (CAEBV) was diagnosed by WHO criteria.
2. Undergo allo-HCT, have achieved full chimerism
3. Age \>18 years old, gender is not limited.
4. After transplantation, EBV was reactivated and EBV-DNA was positive in blood
5. No secondary graft failure. (After grafted, ANC \<0.5\*10\^9/l,PLT \<10\*10\^9/l)
6. No uncontrollable infection
7. Withdraw immunosuppressor, no graft-versus-host disease was observed.
8. Before the start of the study, aminopherase (ALT/AST) and total bilirubin were normal. Serum creatinine ≤ 1.5 times the upper limit of Normal (ULN); No thyroid dysfunction. The left ventricular ejection fraction (LVEF) was normal.
9. Informed consent.

Exclusion Criteria:

1. Allergic to toripalimab
2. Serious immunoreaction: myocardial damage, hepatitis, pneumonia
3. Central nervous system symptoms
4. Serious mental illness;
5. Active bleeding of the internal organs
6. Pancreatitis history. Patients unable to comply during the trial and/or follow-up phase;
7. Participate in other clinical research at the same time.

Primary outcomes:
measure: EBV-DNA turn negative
timeFrame: 4 weeks after PD-1 antibody was used
Secondary outcomes:
measure: treatment-related adverse events as assessed by CTCAE v5.0
timeFrame: 4 weeks after PD-1 antibody was used
Other outcomes:
measure: Survival
timeFrame: 1 year
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Friendship Hospital
name: Zhao Wang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04160936: The Efficacy of Peritubal Analgesic Infiltration in Postoperative Pain Following Percutaneous Nephrolithotomy
Official title: The Effect of Peritubal Infiltration With Bupivacaine Around Nephrostomy Tract on Postoperative Pain Control After Percutaneous Nephrolithotomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Stone
Lead sponsor: University of Jordan
Sponsor class: OTHER
First posted: 2019-11-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The investigators aim to investigate the effect of peritubal local anesthetic infiltration on pain scores and analgesic consumption in patients who underwent percutaneous nephrolithotomy.

Detailed description: The investigators aim to investigate the effect of peritubal local anesthetic on pain scores and analgesic consumption in patients who underwent percutaneous nephrolithotomy. Patients aged between 18 and 65 years with renal stone \>2 cm will be included in this study .The patients will be divided into two groups. In Group A , the drug will be infiltrated to the renal capsule, perinephric fat, muscles, subcutaneous tissue, and skin under fluoroscopy with 0.25 percent bupivacaine. This is a widely-used procedure by surgeons in the world. In Group B, no anesthetic will be infiltrated after the end of the procedure.

Eligibility criteria: Inclusion Criteria:

* 18-70 years of age
* body mass index \<35,
* renal stone size \>2.0 cm.

Exclusion Criteria:

* patients having supra-costal puncture.
* excessive intraoperative bleeding.
* renal stones requiring more than a single puncture.
* surgical procedure extending more than 3 hours.
* urinary tract infection.
* severe cardiopulmonary disease.
* abnormal renal function tests.
* allergy to local anesthetics.

Primary outcomes:
measure: visual analogue scale (VAS )
timeFrame: 1, 4, 8, 12, 24, and 48 hours
measure: Dynamic Visual Analogue Scale (DVAS)
timeFrame: 1 hour, 4 hours, 8 hours, 12 hours, 24 hours, and 48 hours
Secondary outcomes:
measure: The time for the first opioid demand
timeFrame: 48 hours
measure: the number of opioid demands
timeFrame: 48 hours
measure: total opioid consumption
timeFrame: 48 hours
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: Saddam Al Demour
Study officials:
affiliation: The University of Jordan
name: Saddam AlDemour, professor
role: PRINCIPAL_INVESTIGATOR
References: