louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04536376: First Responder Resiliency Program During COVID-19
Official title: First Responder Resiliency Program for Health Care Professionals During a Pandemic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Resilience
Stress
Sleep
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: PNMedical
First posted: 2020-09-02
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Evaluating a wellness program developed to provide effective sustainable solutions for medical professionals providing care to COVID-19 pandemic patients.

Detailed description: Providing mindfulness training at specific time points during study participation with an emphasis on integrating physical and mental health management. The phase-based program delivers individualized, data-driven and quantifiable solutions that directly address pain points impacting healthcare professionals and organizations.

Eligibility criteria: Inclusion Criteria:

1. 18 years of age or older at the time of consent
2. Frontline healthcare professional
3. Have access to an Apple or Android device
4. Not pregnant by subject self-report at time of consent
5. Have the ability to provide informed consent
6. Have no contraindicating comorbid health condition as determined by the clinical investigators

Exclusion Criteria:

1. Currently (within the past 3 weeks) been practicing mindfulness training on a weekly/regular basis
2. Currently (within the past 3 weeks) been undergoing an additional program (e.g. CAM) to improve quality of life or sleep
3. Currently (within 3 weeks) been enrolled in another clinical or research program (e.g. CAM) which intervenes on the patients' QOL, stress or sleep
4. An unstable medical or mental health condition as determined by the physician investigator

Primary outcomes:
measure: Perceived Stress Scale
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Ivana T Croghan, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Brent Bauer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Croghan IT, Hurt RT, Fokken SC, Fischer KM, Lindeen SA, Schroeder DR, Ganesh R, Ghosh K, Bausek N, Bauer BA. Stress Resilience Program for Health Care Professionals During a Pandemic: A Pilot Program. Workplace Health Saf. 2023 Apr;71(4):173-180. doi: 10.1177/21650799221093775. Epub 2022 Jul 5.
Clinical trial NCT02886676: Effect of Arthrospira Platensis (Spirulina) as an Adjunct to Scaling and Root Planing on Salivary Antioxidant Levels in Chronic Periodontitis Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Periodontitis
Lead sponsor: Tatyasaheb Kore Dental College
Sponsor class: OTHER
First posted: 2016-09-01
Enrollment: 70
Sex: ALL
Minimum age (years): 40
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Introduction- Oxidative stress plays a causative role in pathogenesis of periodontal disease.

It has been reported that Spirulina platensis or its active ingredient C phycocyanin (CPC) exerts anti-inflammatory, anti-oxidative and inhibitory effects on prostaglandin and leukotriene biosynthesis.

Aim- To evaluate the effect of dietary spirulina as an adjunct to SRP on salivary antioxidants level in CP subjects.

Materials And Methods- The study was a randomized double-blind clinical and biochemical trial in which 70 subjects with CP in the age group of 40-55 years, reporting to Department of Periodontology, TKDC and RC, New Pargaon, were equally and randomly divided into Test Group (TG) and Control Group (CG). TG was given 2 gm Spirulina capsules daily, after meals for 1 month and CG was not given any supplementary diet. SRP was done at baseline in TG and CG. Whole saliva sample was collected. Clinical and biochemical parameters will be recorded at baseline, 1 month \& 3 months.


Eligibility criteria: Inclusion Criteria:

1. Subjects with CP (moderate and severe)as per CDC criteria 2007.
2. Patients without any known systemic diseases.

Exclusion Criteria:

1. Patients who have taken anti-inflammatory/antibiotic/antioxidant within 3 months of beginning of study.
2. Subjects who have undergone periodontal treatment within six months of inception of study.
3. Tobacco habits in any form and alcoholics.
4. Pregnant and lactating women.

Primary outcomes:
measure: Superoxide dismutase (SOD)
timeFrame: 3 month
measure: Malondialdehyde (MDA)
timeFrame: 3 month
Secondary outcomes:
measure: plaque index
timeFrame: 3 month
measure: Gingival bleeding index
timeFrame: 3 month
measure: Sulcus bleeding index (SBI)
timeFrame: 3 month
measure: Probing depth (PD)
timeFrame: 3 month
measure: Clinical Attachment Level (CAL)
timeFrame: 3 month
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06626776: The Use of Extended Platelet Rich Fibrin in Lateral Sinus Augmentation
Official title: Extended Platelet Rich Fibrin in Lateral Maxillary Sinus Lifting With Simultaneous Implant Placement.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sinus Lift Augmentation
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2024-10-04
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: thirty implants will be inserted in patients seeking implantation of their lost posterior maxillary teeth (premolar and molars) with limited bone height below the floor of the maxillary sinus, secondary to sinus pneumatization. The patients will be selected from those attending the outpatient clinic of the Oral \& Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University.

1. Clinical Evaluation

   • Implant stability
2. Radiographic Evaluation Vertical bone gain (VBG)


Eligibility criteria: Inclusion Criteria:

* Patent ostium of maxillary sinus.
* Patient with missing one or more posterior maxillary teeth.
* Residual bone height of 3-6 mm, measured from the crest of alveolar ridge to the floor of the maxillary sinus at the planned implant site.
* A ridge width at the site of implantation of \<5mm.
* Platelets of normal range.
* Good oral hygiene.
* Patients in the age frame between 20 years and 60 years old.
* No gender preface in selection of the patients.
* A minimum crown height space of 8 mm.

Exclusion Criteria:

* Active sinusitis, cyst, tumors or root tips at the planned surgical site.
* Patients with systemic diseases that contra-indicate the surgical procedure such as uncontrolled diabetes mellitus, bleeding disorders, serious osseous disorders, and mental disorders.
* Heavy smoking and alcoholism.
* Parafunctional habits such as bruxism and clenching.
* Signs of acute infection or pus discharge.
* Disturbed occlusion.

Primary outcomes:
measure: implant stability
timeFrame: 9 months
measure: Vertical bone height
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: MANSOURA University
Study officials:
References:
Clinical trial NCT00843076: Impact of Hepatitis C Virus Variability on Steatosis
Official title: Impact of the Hepatitis C Virus Variability on Liver Steatosis
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Chronic Hepatitis C
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2009-02-13
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic hepatitis C

Brief summary: Chronic infection by the hepatitis C virus (HCV) is a common cause of liver disease, which may progress to cirrhosis and eventually liver cancer. The therapeutic indication will depend mainly on the importance of liver damage (fibrosis), which can be assessed by physical techniques, blood tests and a liver biopsy. The overall objectives of the project are to understand how HCV variability may influence the severity of steatosis (accumulation of fat in the liver), studying 30 patients chronically infected with HCV (half of these patients infected by HCV genotype 3, versus the other half infected by HCV of another genotype). A small portion of the biopsy performed for the routine pathology examination will be placed in special fixation buffer for electron microscopy (EM). Counting and measuring the size of lipid droplets present in the liver by EM will be used to precisely quantify and characterize the liver steatosis. A blood sample of patients will also be collected to sequence the viral genome present in the patient and identify the amino acids involved in an increase in intracellular accumulation of lipid droplets. This work should clarify the impact of the viral variability in the severity of steatosis. Ultimately, the identification of viral sequences responsible for an increase of this phenomenon could be crucial for understanding the mechanisms involved in the steatosis.


Eligibility criteria: Inclusion Criteria:

* Patients with chronic hepatitis C, naive of an antiviral treatment or after relapse or non-response for an antiviral treatment stopped for more than 1 year
* Liver biopsy necessary for the care of the patient
* Signature of informed consent

Exclusion Criteria:

* Patients for which the liver biopsy is estimated ≤ 18 mm, so a portion of 3 mm could not be devoted for the study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Blois
country: France
facility: CH de Blois
city: Bourges
country: France
facility: CH de Bourges
city: Chateauroux
country: France
facility: CH de Châteauroux
city: Dreux
country: France
facility: CH de Dreux
city: Orleans
country: France
facility: CHR Orléans
city: Tours
country: France
facility: CHRU de Tours
Study officials:
affiliation: INSERM ERI 19
name: Philippe ROINGEARD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00628576: Evaluation of Long-Term Sequelae After Thrombophlebitis, i.e. Deep Venous Thrombosis of the Lower Extremities
Official title: Deep Venous Thrombosis. Long-Term Results After Treatment With Either Low-Molecular -Weight Heparin or Unfractionated Heparin. Examinations of the Venous System.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Deep Venous Thrombosis
Keywords: Deep Venous Thrombosis
lower extremities
Chronic Venous Insufficiency
Postthrombotic Syndrome
Heparins
Low-molecular- weight heparin
Tinzaparin
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
Collaborators: name: Aalborg University
First posted: 2008-03-05
Enrollment: 99
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 the study was to evaluate efficacy and safety of the new acute treatment of deep venous thrombosis by use of low-molecular-weight heparin compared with standard treatment using unfractionated heparin, especially concerning long-term morbidity.

Detailed description: Deep-venous thrombosis (DVT) remains a common clinical problem (annual incidence 0.10-0.16%) and long-term morbidity as chronic venous insufficience (CVI) in 10-30%.

As to recurrent DVT, initial treatment with Low-Molecular-Weight Heparin ( to-day's terminology Fractionated Heparin (FH)) and Unfractionated Heparin (UFH) has shown equal efficiency, whereas the efficacy concerning long-term morbidity has only more recently been published.

This study was initiated to compare the efficacy of UFH and FH concerning the incidence of CVI after symptomatic DVT at short-term and long-term follow-up.

Eligibility criteria: Inclusion Criteria:

* First DVT with or without known risk factors except overt cancer
* Second DVT more than two years after the first if the patient was without clinical signs of CVI.

Exclusion Criteria:

* Contraindication to anticoagulation therapy
* Candidate to thrombectomy with arterious-venous fistula or thrombolytic therapy
* Known cancer at the time of the DVT diagnosis
* Patients unable to cooperate for anticoagulation therapy or manage the tests.

Primary outcomes:
measure: Clinical evaluation of chronic venous insufficiency (CVI) - (Postthrombotic Syndrome) based on internationally accepted criteria.
timeFrame: Two years and 6 to 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Dept. of Haematology; Aalborg Hospital
state: Region Nordjylland
Study officials:
affiliation: Department of Haematology; Aalborg Hospital, 9100 Aalborg, Denmark
name: Benedicte Laursen, MD, DMSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00794976: Dexamethasone Iontophoretic Patch for the Treatment of Pain Associated With Lateral Epicondylitis
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Safety and Efficacy of a Dexamethasone Iontophoretic Transdermal Patch for the Treatment of Pain Associated With Lateral Epicondylitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lateral Epicondylitis
(Tennis Elbow)
Lead sponsor: Travanti Pharma Inc.
Sponsor class: INDUSTRY
Collaborators: name: ResearchPoint
First posted: 2008-11-21
Enrollment: 216
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 objective of this study is to determine the safety and efficacy of a dexamethasone iontophoretic transdermal patch for the treatment of pain associated with lateral epicondylitis (tennis elbow).

Detailed description: Detailed Description:

This trial is a randomized, double-blind, placebo-controlled, parallel-group trial in subjects diagnosed with lateral epicondylitis (tennis elbow). Subjects entered into the trial will be assigned to one of four treatment groups. The total duration is up to 13 days of trial participation.

Eligibility criteria: Inclusion Criteria:

* Subjects with onset of lateral epicondylitis symptoms no more than 12 weeks prior to study entry
* Female patients of childbearing potential must agree to use a medically accepted form of birth control.

Exclusion Criteria:

* Subjects with other medical conditions/injuries of the elbow that would account for pain in the area
* Subjects who would require continuation of current pain medications during treatment
* Must not have received a prior corticosteroid injection for lateral epicondylitis in the affected arm

Primary outcomes:
measure: Pain severity assessed by VAS (Visual Analog Scale)
timeFrame: baseline to completion/termination
Secondary outcomes:
measure: Safety
timeFrame: up to 13 days
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: San Diego
country: United States
state: California
city: Steamboat Springs
country: United States
state: Colorado
city: Tampa
country: United States
state: Florida
city: Oklahoma City
country: United States
state: Oklahoma
city: Columbia
country: United States
state: South Carolina
city: Dallas
country: United States
state: Texas
city: Arlington
country: United States
state: Virginia
Study officials:
affiliation: Travanti Pharma Inc.
name: Robert Arnold
role: STUDY_DIRECTOR
References:
Clinical trial NCT01117376: Methylnaltrexone vs Erythromycin for Facilitating Gastric Emptying Time in Critically Ill Patients
Official title: Methylnaltrexone vs Erythromycin for Facilitating Gastric Emptying Time in Critically Ill Patients Intolerant to Enteral Feeding
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Gastroparesis
Keywords: Gastroparesis
Erythromycin
Methylnaltrexone
ICU
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
First posted: 2010-05-05
Enrollment: 42
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: TREATMENT

Brief summary: 42 patients admitted in ICU with intolerance to enteral feeding (GRV more than 250 ml) are recruited. All patients enter a primary acetaminophen absorption test study as baseline. Serum levels of acetaminophen will be measured by florescence polarization method at 15,30,45,60,90,120,180,240,480 minutes after enteral administration of 975 mg acetaminophen. Then the patients will be randomized to methylnaltrexone or erythromycin group.Another acetaminophen absorption test with the same schedule will be done after the last dose of each drug.The area under the curve for acetaminophen blood level will be used to compare the effect of two studied drugs on gastric emptying time.


Eligibility criteria: Inclusion Criteria:

* Patients admitted in intensive care unit in a university affiliated hospital
* Receiving continuous enteral feeding through a nasogastric tube
* Gastric residual volume more than 250 ml checked by aspiration technique

Exclusion Criteria:

* Receiving the study drugs or metoclopramide within 24 hours of inclusion
* Known allergy to interventional drugs or acetaminophen
* Gastrointestinal bleeding or surgery on GI system within 24 hours of inclusion
* Crohn's disease
* GI perforation or obstruction
* Short bowel syndrome
* Liver failure or 2 of the followings:

  * Transaminase enzymes more than 3 times normal
  * Prothrombin time more than 2 times normal
  * Total bilirubin more than 3 times normal
* Patients on hemodialysis or CRRT
* Hemodynamically unstable patients including:

  * Mean arterial pressure less than 65 mmHg
  * Infusion of inotropes and vasopressors
  * Uncorrected acute blood loss; hemoglobin concentration less than 6.5 mg%.
* Documented or suspected pregnancy
* Obesity; actual body weight more than 1.5 times ideal body weight
* Myasthenia Gravis.
* Opioid drug abuse

Primary outcomes:
measure: Gastric emptying time
timeFrame: within 8 hours after drug administration
Secondary outcomes:
measure: Tolerance to enteral feeding
timeFrame: 24 hours after intervention
Other outcomes:
Locations:
city: Shiraz
country: Iran, Islamic Republic of
facility: Nemazee Hospital
state: Fars
Study officials:
References:
Clinical trial NCT02382276: A Long-term Extension Study for the Phase 3 Study of Nalmefene (339-14-001) in Patients With Alcohol Dependence
Official title: A Long-term Extension Study for the Phase 3 Study of Nalmefene (339-14-001) in Patients With Alcohol Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Alcohol Dependence
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: H. Lundbeck A/S
First posted: 2015-03-06
Enrollment: 405
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The long-term safety and efficacy of nalmefene hydrochloride at 20 mg in patients with alcohol dependence will be evaluated in a multicenter, open-label, uncontrolled trial.


Eligibility criteria: Inclusion Criteria:

* Patients who have completed Study 339-14-001
* Patients who have signed the informed consent form for Study 339-14-002

Exclusion Criteria:

* The patient has a clinically significant unstable illness (eg, complication of New York Heart Association (NYHA) class III or IV heart failure or angina pectoris, renal function disorder with estimated glomerular filtration rate (eGFR) of \< 30 mL/min/1.73 m2, hepatic failure, and neoplastic disorder)
* The patient has a clinically significant abnormal electrocardiogram (ECG) which is inappropriate for the participation in the trial in the opinion of the investigator or subinvestigator

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: 24-week treatment period
Secondary outcomes:
measure: Change in the Number of Heavy Drinking Days (HDDs) From Baseline
timeFrame: Week 24
measure: Change in Total Alcohol Consumption (TAC) From Baseline
timeFrame: Week 24
Other outcomes:
Locations:
city: Region
country: Japan
facility: Chubu
city: Region
country: Japan
facility: Hokkaido
city: Region
country: Japan
facility: Kanto
city: Region
country: Japan
facility: Kinki
city: Region
country: Japan
facility: Kyusyu
city: Region
country: Japan
facility: Tohoku
city: Region
country: Japan
facility: Tyugoku
Study officials:
affiliation: Otsuka Pharmaceutical Co., Ltd.
name: Ono Hiroaki, Mr
role: STUDY_DIRECTOR
References:
Clinical trial NCT06979076: A Phase Ib Study of the Selective PKC-β Inhibitor MS-553 in Patients With Refractory or Relapsed CLL/SLL
Official title: A Phase Ib Study of the Selective PKC-β Inhibitor MS-553 in Patients With Refractory or Relapsed Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: CLL (Chronic Lymphocytic Leukemia)
SLL (Small Lymphocytic Lymphoma)
Lead sponsor: MingSight Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2025-05-18
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Phase Ib Study of the Selective PKC-β Inhibitor MS-553 in Patients with Refractory or Relapsed Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma


Eligibility criteria: Inclusion Criteria:

1. Age 18 years or older.
2. Diagnosis of CLL or SLL:

   1. History of histologically documented CLL or SLL that meets iwCLL diagnostic criteria according to the 2018 guidelines, and
   2. Indication for treatment as defined by the 2018 iwCLL guidelines, or the need for disease reduction prior to allogeneic transplantation.-

Exclusion Criteria:

1. Current transformation of CLL/SLL non-Hodgkin lymphoma or Hodgkin lymphoma.
2. Active and uncontrolled autoimmune cytopenia(s).

Primary outcomes:
measure: The occurrence of AEs and SAEs, with abnormal laboratory tests results, abnormal physical examination findings, abnormal vital signs, and abnormal ECG readings
timeFrame: Through study completion, an average of 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: