louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06138535: Evaluation of Digital Stabilizing Splint in Management of Masticatory Muscle Disorder
Official title: Evaluation of Digital Stabilizing Splint in Management of Masticatory Muscle Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Disorder
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
Collaborators: name: Al-Azhar University
First posted: 2023-11-18
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: single arm group study
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to evaluate the digital stabilizing splint in management of masticatory muscle disorder. The main question it aims to answer are:

• is the digital stabilizing splint effective in treatment of masticatory muscle disorder signs and symptoms after 3 months follow up ? Participants will be asked to ware the splint and progressively increasing the duration of splint wear, starting from 8 hours per day for 3 months .

Detailed description: The current research was conducted for evaluation of the digital stabilizing splint in the management of masticatory muscle disorder. Subjects and Methods: Eight patients over the age of 18 with masticatory muscle disorders received treatment using a stabilizing splint that was digitally created. The Each patient's response to therapy modifications was assessed and compared before and after splint insertion for each patient subjective symptoms were assessed using a patient questionnaire that was repeated before treatment (baseline), one month, and 3 months post-insertion. Moreover, The masseter and temporalis muscles' electrical activity was measured using electromyography at baseline and after three months.post-splint insertion. Clinical signs such as mouth-opening lateral movements and protrusive movements were measured before and 3 months after the splint was inserted.

Eligibility criteria: inclusion criteria

1-Anterior disc displacement without reduction or osteoarthritis cases 2-Pain and/or tenderness of masticatory muscles exclusion criteria

1. Absence of previous occlusal splint therapy.
2. Absence of apparent dental or periodontal diseases.
3. Patients having full or partial dentures that would compromise the support of an occlusal splint were excluded.
4. Patient taking analgesics, muscle relaxants, or Anti-inflammatory medications will not be included because they may affect the outcome.
5. Patients with multiple teeth loss that affects occlusal splint support were excluded.

Primary outcomes:
measure: Patient questionnaire (clinical symptoms).
timeFrame: 3 months
Secondary outcomes:
measure: Clinical sign such as mouth opening
timeFrame: 3 months
Other outcomes:
measure: Evaluation of muscle activation with surface electromyography (EMG)
timeFrame: 3 months
Locations:
city: Cairo
country: Egypt
facility: Al Azhar University
Study officials:
affiliation: Al-Azhar University
name: zahraa hassan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00168935: Malnutrition in Gastroenterology Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Malnutrition
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2005-09-15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Background: Malnutrition is frequently occurring in sick patients and is associated with a higher morbidity and mortality. Muscle dysfunction is a common finding in malnutrition which leads to a reduced functional status and quality of life.

Specific aims: The purpose of the study is to evaluate the effect of a three month nutritional intervention with oral supplements on nutritional status, muscle function and quality of life.


Eligibility criteria: Inclusion Criteria:

* Malnutrition
* Benign disease

Exclusion Criteria:

* Malignant disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charite Universitätsmedizin Berlin CCm
Study officials:
affiliation: Charite Universitätsmedizin Berlin ,Klinik für Gastroenterologie CCM
name: Matthias Pirlich, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Norman K, Pirlich M, Smoliner C, Kilbert A, Schulzke JD, Ockenga J, Lochs H, Reinhold T. Cost-effectiveness of a 3-month intervention with oral nutritional supplements in disease-related malnutrition: a randomised controlled pilot study. Eur J Clin Nutr. 2011 Jun;65(6):735-42. doi: 10.1038/ejcn.2011.31. Epub 2011 Mar 16.
Clinical trial NCT00877435: Prize Reinforcement Contingency Management for Cocaine Dependence: a 24-week Randomized Controlled Trial
Official title: Prize Reinforcement Contingency Management for Cocaine Dependence: a 24-week Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cocaine-related Disorders
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2009-04-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether prize-based contingency management (prizeCM) combined with cognitive behavioral therapy (CBT) is more effective in the treatment of of cocaine-dependent patients compared to CBT only. Patients were randomized to prizeCM + CBT (experimental group) or to CBT (control group) an treated over 24 weeks. It is the first trial of this type in Europe.


Eligibility criteria: Inclusion Criteria:

* cocaine dependence, aged 18 or older, other dependences

Exclusion Criteria:

* severe somatic, brain, or psychiatric disease, attention deficit disorders with medication methylphenidate

Primary outcomes:
measure: retention in treatment, cocaine abstinence
timeFrame: 24 weeks
Secondary outcomes:
measure: patients' satisfaction with the therapy, clinical measures
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Universitäre Psychiatrischen Kliniken
city: Geneva
country: Switzerland
facility: Fondation Phenix
Study officials:
affiliation: Psychiatric Hospital of the University of Basel
name: Sylvie A Petitjean, Dr. phil.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04833335: ASL in Brain Metastasis MRI Following Gamma Knife Treatment
Official title: ASL in Diagnostics of Tumor Progression Versus Radionecrosis in Brain Metastasis Following Gamma Knife Treatment.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Brain Metastases
Keywords: ASL
MRI
Metastasis
Gamma knife
Radionecrosis
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2021-04-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Arterial spin labeling (ASL) is a non-invasive MRI technique that could help the radiologists to distinguish brain metastasis progression versus radionecrosis following gamma-knife treatment.

The primary target of the study is to establish the diagnostic performances (specificity, sensitivity) of quantitative measures of ASL in brain metastases suspected of progression/radionecrosis after GK treatment

Detailed description: The metastasis progression versus radionecrosis following GK treatment can sometimes be difficult to distinguish. 60 patients will be included in this prospective, monocentric study. 3 MRI (baseline, 1month and 6 month follow-ups) will be performed. Two neuroradiologists will blindly analyse the MRIs comparing ASL sensibility and specificity to the standard morphological evaluation and T2 perfusion.

Eligibility criteria: Inclusion Criteria:

* Brain metastasis from histologically proven tumor
* GK treatment within 4 month prior to the inclusion
* Lesions suspected of progression/ radionecrosis :

  i.e.≥ 25% of the size progression
* Lesion size: gadolinium enhanced part of the tumour ≥1 cm

Exclusion Criteria:

* Pregnancy
* Medical history of primitive brain tumour
* MRI incompatibility/ medical history of contrast agent allergy
* Claustrophobia
* Patient unable to consent
* Epilepsia/recent stroke
* Patients participating in other studies
* Patients without health care insurance

Primary outcomes:
measure: Diagnostic performance of ASL quantitative analysis in brain metastasis following GK treatment : tumor perfusion with quantitative measurement (one value) of RCBF (relative cerebral blood flow) on the ASL sequence
timeFrame: Evolution between Baseline MRI, 1 and 6 month follow up MRI
Secondary outcomes:
measure: ASL Perfusion: Cerebral blood flow measurements
timeFrame: Baseline MRI, 1 and 6 month follow up MRI
measure: Interreader correlation
timeFrame: Baseline MRI, 1 and 6 month follow-up MRI
measure: Morphological analysis of the lesions
timeFrame: Baseline MRI, 1 and 6 month follow-up MRI
Other outcomes:
Locations:
city: Paris
country: France
facility: Service de neuroradiologie, hôpital Pitié Salpêtrière
Study officials:
References:
Clinical trial NCT00542035: A Study of ARRY-371797 in Subjects Undergoing Third Molar Extraction
Official title: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP ANALGESIC EFFICACY TRIAL OF ORAL ARRY-371797 IN SUBJECTS UNDERGOING THIRD MOLAR EXTRACTION
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dental Pain
Keywords: Analgesia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-10-10
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a Phase 2 study designed to test the ability of investigational study drug ARRY-371797 to reduce pain either perioperatively or postoperatively in a third molar extraction pain model, and to further evaluate the drug's safety. Approximately 150 subjects from the US will be enrolled in this study.


Eligibility criteria: Key Inclusion Criteria:

* Scheduled for outpatient oral surgical procedure to remove 2 ipsilateral third molars, at least 1 of which is mandibular and fully or partially impacted by bone.
* Females of childbearing potential must be willing to use an acceptable method of contraception within 14 days prior to first dose of study drug until the completion of the follow-up procedures.
* Body weight \>50 kg (110 lbs).
* Good health determined by medical history, physical examination, vital signs and clinical laboratory results of non-clinical significance.
* Additional criteria exist.

Key Exclusion Criteria:

* Positive urine drug screen.
* Use of prescription or nonprescription drugs, herbal or dietary supplements, vitamins, or grapefruit juice within 14 days prior to first dose of study drug.
* Additional criteria exist.

Primary outcomes:
measure: Assess the efficacy of the study drug dosed either perioperatively or postoperatively in terms of total pain relief (TOTPAR) and total pain intensity (visual analog scale, VAS).
timeFrame: 6 hours post dose 2
measure: Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, electrocardiograms and vital signs.
timeFrame: Duration of study
Secondary outcomes:
measure: Compare the efficacy of the study drug dosed perioperatively versus postoperatively in terms of total pain intensity (VAS).
timeFrame: Duration of study
Other outcomes:
Locations:
city: San Marcos
country: United States
facility: SCIREX Research Center
state: Texas
city: Salt Lake City
country: United States
facility: SCIREX Research Center
state: Utah
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04187235: Laparascopic Keyhole vs Sugarbaker Repair in Parastomal Hernia
Official title: Laparascopic Keyhole vs Sugarbaker Repair in Parastomal Hernia: A Long Term Case-controlled Prospective Study of Consecutive Patients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parastomal Hernia
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
First posted: 2019-12-05
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with parastomal hernia referred to Aarhus University Hospital

Brief summary: This is a non-randomised case-controlled prospective study of consecutive patients with parastomal hernia, comparing the laparoscopic Keyhole repair with the modified Sugarbaker repair.

Detailed description: Objective: To compare the laparoscopic Keyhole repair with the modified Sugarbaker repair in a nonrandomised case-controlled prospective study of consecutive patients with parastomal hernia.

Summary Background Data: Two reviews of uncontrolled studies concluded that the Sugarbaker repair is superior to the Keyhole repair. The present study challenges the claim.

Methods: In two time periods 135 patients with a parastomal hernia were repaired with the Keyhole technique (74 patients, using a two-layer mesh of polypropylene and ePTFE with a self-cut slit, 1997- 2009) or the Sugarbaker technique (61 patients, using a coated polypropylene mesh, 2009-2015). The patients in the two groups matched with regard to age, gender, ASA score, colostomy or ileostomy hernia, previous repairs, size of fascial defect and simultaneous repair of a concurrent incisional hernia. Observation time was defined as time to recurrence, stoma re-siting, mesh removal, death, or last non-event visit

Eligibility criteria: Inclusion Criteria: Patients with a diagnosis of parastomal hernia and indication for surgical treatment -

Exclusion Criteria: None

-

Primary outcomes:
measure: Recurrence
timeFrame: 3 years
Secondary outcomes:
measure: Mesh-related morbidity
timeFrame: 3 years
measure: Postoperative complications
timeFrame: 30 days after surgery
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
Study officials:
affiliation: Aarhus University Hospital
name: Paul Wara, DMSc
role: STUDY_CHAIR
References:
Clinical trial NCT01518335: Use of Platelet Rich Plasma Therapy for Acute Ankle Sprains in the Emergency Department
Official title: A Double-Blind, Randomized, Placebo Controlled Study Evaluating the Use of Platelet Rich Plasma Therapy for Acute Ankle Sprains in the Emergency Department.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sprain of Ankle
Keywords: platelet rich plasma
ankle
sprain
injection
Platelet Rich Plasma therapy
focal, invasive therapy for sprains
Lead sponsor: Albert Einstein Healthcare Network
Sponsor class: OTHER
First posted: 2012-01-26
Enrollment: 38
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 research study hopes to determine whether or not platelet rich plasma therapy improves healing time of moderate to severe ankle sprain in comparison to standard of care therapy.

Detailed description: The intention of this research project is to study a new treatment for severe ankle sprains.This new treatment is called Platelet Rich Plasma (PRP) therapy and involves injecting concentrated platelet's from a patient's own blood into the site of injury to aid healing. Platelets, aside from their clotting capabilities also serve a role in re-vascularization of tissue as well as collagen repair. PRP therapy has been used in sports medicine for treatment of chronic injuries but has yet to be proven effective in acute injury of a joint. The investigators are comparing treatment and placebo groups based on a subjective patient questionnaire and pain score administered on the day of injury and 2-3 days and 8-10 days follow up.

Eligibility criteria: Inclusion Criteria:

* severe ankle sprain
* X-ray completed

Exclusion Criteria:

* Pregnancy/breastfeeding
* Police custody
* active infection
* metastatic disease/tumors
* History of thrombocytopenia
* Allergy to ester or amine anesthetics
* On anticoagulant medication
* Peripheral vascular disease
* Known coagulopathy

Primary outcomes:
measure: Change from baseline of LEFS score, a previous validated 80-point scale used to quantify lower extremity function.
timeFrame: Day 0; Day2-3; Day 8-10; Day30
Secondary outcomes:
measure: Change in pain from baseline
timeFrame: Day 0; Day 2-3, Day 8-10, Day 30
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Einstein Healthcare Network
state: Pennsylvania
Study officials:
affiliation: Eisntein Healthcare Network
name: Adam Rowden, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01578135: French National Registry of Children Born Small for Gestational Age Treated With Somatropin
Official title: French National Longitudinal Prospective Follow-up of Children Born Small for Gestational Age and Treated With Norditropin SimpleXx (French Health Authorities Commitment)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Growth Disorder
Small for Gestational Age
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-04-16
Enrollment: 291
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Phase I: All patients born SGA treated with Norditropin® SimpleXx® (somatropin) whether they were previously treated with another growth hormone for this indication or not from the 29th of April 2005 until 29th of April 2010.

Phase II: Sub-population randomly selected (every 5th patient being included in registry in study phase I).

Brief summary: This study is conducted in Europe. The aim of the study is to describe the patient population and therapeutic practices (study phase I), assess efficacy on growth and adult height and assess tolerance of somatropin (Norditropin® SimpleXx®) (study phase II)


Eligibility criteria: Inclusion Criteria:

* Born small for gestational age

Primary outcomes:
measure: Growth in height
timeFrame: 6 months after inclusion into registry and then annually until adult height is reached
Secondary outcomes:
measure: Blood pressure: Systolic and diastolic
timeFrame: 6 months after inclusion into registry and then annually until adult height is reached
measure: Bone age
timeFrame: 6 months after inclusion into registry and then annually until adult height is reached
measure: Insulin-Like Growth Factor 1 (IGF-1)
timeFrame: 6 months after inclusion into registry and then annually until adult height is reached
Other outcomes:
Locations:
city: Paris La Défense
country: France
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT00310635: Safety, Tolerability and Immunogenicity of Meningococcal C Conjugate Vaccine to Children 32 to 40 Months of Age
Official title: A Phase IV, Multi-Center, Controlled Open-Label Study to Evaluate the Safety, Tolerability and Immunogenicity of a Commercially Available Meningococcal C Vaccine When Given as First, Third or Fourth Immunization to Children 32-40 Months of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Meningococcal Infection
Keywords: Prevention of meningococcal infection
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Novartis Vaccines
First posted: 2006-04-04
Enrollment: 241
Sex: ALL
Minimum age (years): 32
Maximum age (years): 40
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Safety, Tolerability and Immunogenicity of Meningococcal C Conjugate Vaccine to Children 32 to 40 Months of Age


Eligibility criteria: Inclusion Criteria:

* Healthy children

Exclusion Criteria:

* known hypersensitivity to any vaccine component
* significant acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the past 14 days
* ascertained or suspected disease caused by N. meningitidis
* household contact with or intimate exposure to an individual with a positive culture of N. meningitidis serogroup C within the previous 60 days

Primary outcomes:
measure: Determination of memory antibody response to Neisseria meningitidis serogroup C after 2 or 3 doses of MenC vaccine given during infancy, as measured by hBCA at day 0 and day 28.
Secondary outcomes:
measure: Determination of antibody titers in naïve control subjects.
measure: Determination of persistence of antibody response after either 2 or 3 doses of MenC vaccine given during infancy and one dose of MenPS A/C vaccine given at 12 months of age.
measure: Evaluation of the safety and tolerability of a single 0.5 mL intramuscular (IM) injection of MenC Vaccine when given to children approximately three years of age.
Other outcomes:
Locations:
city: Oppenheim,
country: Germany
facility: Mainz, Kehl, Traunreut, Mühldorf am Inn, Bad Sobernheim, Bad Kreuznach, Baldham, Speyer,
state: Kempten
Study officials:
affiliation: Novartis Vaccines & Diagnostics
name: Vaccines - Information Services
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06067035: Hepatic Small Vessel Neoplasm
Official title: Imaging of Small-vessel Liver Tumours
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hepatic Small Vessel Neoplasm
Keywords: Vascular tumors
Hepatic imaging
Neoplasm
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2023-10-04
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with small-vessel liver tumours

Brief summary: Small-vessel hepatic tumor is a new tumor entity of vascular origin, described in 2016 by Gill et al, in a series of 17 patients. This rare lesion is difficult to diagnose on imaging because it shares a common radiological semiology with several other differential diagnoses ranging from benign hepatic angioma to more aggressive lesions such as angiosarcoma.

Detailed description: The aim of our study is to enable the imaging diagnosis of a new entity: small vessel hepatic tumor in order to improve diagnostic management.

Eligibility criteria: Inclusion Criteria:

* Histological evidence of a small vessel hepatic tumor either on biopsy or surgical specimen
* Cross-sectional imaging before the biopsy or pre-operatively (CT, MRI)

Exclusion Criteria:

* Patient under guardianship or curators

Primary outcomes:
measure: Imaging findings
timeFrame: 12 months
Secondary outcomes:
measure: Pathological examination
timeFrame: 12 months
measure: Biology
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: APHP
name: MAITE LEWIN, MD, PHD
role: STUDY_DIRECTOR
References: