louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03749408: Effect of Addition of Mannitol to Bupivacaine on IANB Success and Post-endodontic Pain
Official title: Effect of Addition of 0.5 Mol/L Mannitol to 0.5% Bupivacaine on IANB Success and Post-endodontic Pain in Mandibular Molars With Irreversible Pulpitis: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Irreversible Pulpitis
Keywords: inferior alveolar nerve block
long-acting local anesthesia
bupivacaine
mannitol
symptomatic irreversible pulpitits
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-11-21
Enrollment: 60
Sex: ALL
Minimum age (years): 17
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Inferior alveolar nerve block using either 0.5% bupivacaine alone or in addittion to mannitol in patients with irreversible pulpitis in mandibular molars.

Detailed description: Patients with irreversible pulpitis in mandibular molars will be selected according to the eligibility criteria and patients are then randomized to either using 0.5% bupivacaine alone or in addition to mannitol. Anesthetic success and postoperative pain will then be assessed.

Eligibility criteria: Inclusion Criteria:

1. Adult patients; age between 17-35 years old.
2. Males or Females.
3. Medically-free patients
4. Patients suffering from symptomatic irreversible pulpitis without apical periodontitis in mandibular molar teeth.
5. Positive patients' acceptance for participation in the study.

Exclusion Criteria:

* Patients who had any analgesic during proceeding 12 hours before the treatment.
* Teeth with necrotic, infected pulp, swelling or symptomatic apical periodontitis (apical abscess).
* Pregnant females.
* Patients with history of significant medical conditions (contraindication of mannitol use).
* Addiction
* Psycological disturbance.

Primary outcomes:
measure: Postoperative pain intensity ranging from 0-10 where 0 means no pain, 10 the worst pain
timeFrame: 6 hours
measure: Postoperative pain intensity ranging from 0-10 where 0 means no pain, 10 the worst pain
timeFrame: 12 hours
measure: Postoperative pain intensity ranging from 0-10 where 0 means no pain, 10 the worst pain
timeFrame: 24 hours
measure: Postoperative pain intensity ranging from 0-10 where 0 means no pain, 10 the worst pain
timeFrame: 48 hours
measure: Postoperative pain intensity ranging from 0-10 where 0 means no pain, 10 the worst pain
timeFrame: 72 hours
Secondary outcomes:
measure: Anesthetic success
timeFrame: 1 hour
measure: lip numbness duration
timeFrame: 24 hours
measure: Medication intake
timeFrame: 72 hours
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00691808: Study of LX6171 in Elderly Volunteers With Age Associated Memory Impairment
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Determine Safety and Tolerability of LX6171 Oral Suspension Dosed for 28 Days in Subjects Exhibiting Age Associated Memory Impairment (AAMI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Age-Related Memory Disorders
Lead sponsor: Lexicon Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-06-05
Enrollment: 103
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine the safety, tolerability, and effectiveness of 2 dose levels of LX6171 given over 28 days in patients with Age Associated Memory Impairment (AAMI).


Eligibility criteria: Inclusion Criteria:

* Males and females aged 60-80 years old.
* Complaints of memory loss in everyday life
* Non-smokers or very light smokers (no more than 10 cigarettes/day)
* Negative urine screen for drugs of abuse
* Ability to provide written informed consent

Exclusion Criteria:

* History or evidence of any disease, disorder or injury that could cause cognitive deterioration.
* Need for medications other than hormone replacement therapy, daily vitamins, or over-the-counter pain killers
* Clinically significant abnormality on electrocardiogram
* History of alcoholism or drug dependence
* Use of dietary supplements containing Huperzine A, gingko biloba, phosphatidylserine, or Docosahexaenoic acid (DHA)

Primary outcomes:
measure: Number of Participants Who Were Exposed to LX6171
timeFrame: ≥28 days
measure: Number of Participants Who Were Exposed to LX6171
timeFrame: 25 to 27 days
measure: Number of Participants Who Were Exposed to LX6171
timeFrame: 14 to18 days
measure: Number of Subjects Reporting at Least One Adverse Event (AE)
timeFrame: 28 days
measure: Number of Subjects Reporting Adverse Events Leading to Withdrawal
timeFrame: 28 days
measure: Treatment Compliance
timeFrame: End of study
Secondary outcomes:
measure: Plasma Concentration
timeFrame: Day 28
measure: Change From Baseline (Day -1) in 15-Words Test: Acquisition Score at Day 28
timeFrame: Day 28
measure: Change From Baseline in 15-Word Test: Short-Term Delayed Recall Score at Day 28
timeFrame: Day 28
measure: Change From Baseline in Memory Assessment Clinics Self-Rating Scale Total Score at Day 28
timeFrame: Day 28
measure: Change From Baseline in Pittsburgh Sleep Quality Index at Day 28
timeFrame: Day 28
measure: Change From Baseline in Epworth Sleepiness Scale at Day 28
timeFrame: Day 28
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: Kendle Netherlands
city: Zuidlaren
country: Netherlands
facility: Pharmaceutical Research Associates Group BV
Study officials:
affiliation: Lexicon Pharmaceuticals, Inc.
name: Philip M. Brown, M.D., J.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT06071208: Prevent Diabetic Kidney Disease Among Egyptians
Official title: The National Plan To Prevent Diabetic Kidney Disease Among Egyptians: A Prospective Multicenter Randomized Controlled Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Diabetes Mellitus Without Complication
Lead sponsor: Fayoum University
Sponsor class: OTHER
Collaborators: name: Cairo University
name: NewGiza University
First posted: 2023-10-06
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: diabetics aged 18 years and above,male or females will be subjected to assessment of kidney functions at the beginning of the study and at the end to assess possibility of protective effect of SGLT-2,assessmentof other diabetic complications will be done also. Prediabetics will subjected to same assessment also

Brief summary: Study of the possibility to prevent the development of Diabetic kidney disease in type 2 diabetic patients

Detailed description: Study of the possible role of the SGLT2 inhibitors to prevent the development of frank type2 DM among prediabetic candidates.

Study of the possible role of the SGLT2 inhibitors to prevent the development of diabetic complications, namely diabetic kidney disease, diabetic retinopathy and neuropathy.

Eligibility criteria: Inclusion Criteria:

* diabetics,prediabetics

Exclusion Criteria:

-

Primary outcomes:
measure: prevention of diabetic complications
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Usama Sharaf El Din, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04209608: Observational Study on Respiratory Impact of High-frequency Jet Ventilation (JVHF) in Interventional Radiology (RI)
Official title: Observational Study on Respiratory Impact of High-frequency Jet Ventilation (JVHF) in Interventional Radiology (RI)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia Complication
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2019-12-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will be offered to patients benefiting from thermoablation of abdominal tumors under JVHF. Recruitment will take place during the pre-anesthetic consultation.

Brief summary: Jet ventilation is used in interventional radiology to reduce respiratory movement and facilitate tumor destruction. The purpose of this study is to describe the respiratory impact of this technique

Detailed description: Use imaging and respiratory data to describe the impact of JVHF during tumor thermoablation procedures

Eligibility criteria: Inclusion Criteria:

* Major patient
* Patient benefiting from an abdominal tumor thermoablation procedures
* Patient who gave consent
* Patient with a social protection scheme

Exclusion Criteria:

* Pulmonary thermoablation procedures
* Thermoablation of abdominal tumors required a transpleural passage
* Patient under guardianship or curatorship
* Patient not understanding French

Primary outcomes:
measure: evaluate the respiratory impact after the use of JVHF after thermoablation of a solid abdominal tumour.
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Describe the number of ventilatory disorders
timeFrame: through study completion, an average of 1 year
measure: Describe the incidence of hypoxemia during JVHF
timeFrame: through study completion, an average of 1 year
measure: Describe the incidence of hypercapnia at the time of a JVHF
timeFrame: through study completion, an average of 1 year
measure: Describe the incidence of barotraumatic pulmonary lesions at the time of a JVHF
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
Study officials:
References:
Clinical trial NCT04506008: Hypofractionated Radiotherapy Followed by Surgical Resection in the Treatment of Soft Tissue Sarcomas
Official title: Prospective Observational Trial of Two Neoadjuvant Hypofractionated Radiotherapy Regimens Followed by Surgical Resection in the Treatment of Soft Tissue Sarcomas
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Soft Tissue Sarcomas
Keywords: Hypofractionated Radiotherapy
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
First posted: 2020-08-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The trial will use neoadjuvant hypofractionated radiotherapy followed by surgical resection in the treatment for soft tissue sarcoma. It will allow patients to be treated over a shorter course (5 or 15 days of radiation) compared to the traditional 5 week regimen. It is proposed that this will be possible without increasing the risk of wound complication or local recurrence compared with a traditional 5 week course of pre-operative radiation.

Detailed description: Study Objectives:

Primary:

* To investigate the efficacy of neoadjuvant hypo-fractionated radiotherapy (HRT) followed by surgical resection in the treatment of soft tissue sarcoma (STS) as measured by local control
* Examine the side effect profile using Radiation Therapy Oncology Group (RTOG) and Common Terminology Criteria for Adverse Events (CTCAE) acute and late side effects criteria and major and minor post-operative complication rates.

OUTLINE: Patients are assigned to 1 of 2 groups by the radiation oncologist.

GROUP I (ULTRA-HYPOFRACTIONATION \[UH\]): Patients undergo HRT daily for a total of 5 fractions followed by surgery.

GROUP II (MODERATE HYPOFRACTIONATION \[MH\]): Patients undergo HRT daily for a total of 15 fractions followed by surgery.

After completion of study treatment, patients are followed up within 3 months, then every 3-6 months for a minimum of 2 years.

Eligibility criteria: Inclusion Criteria:

* Histologic diagnosis of a soft tissue sarcoma of extremity, pelvis, chest wall or trunk/abdominal wall (non-retroperitoneal location)
* ECOG performance status 0-2
* Patient must be deemed able to comply with radiation treatment and surgery

Exclusion Criteria:

* History of prior radiation to the same area to be irradiated
* Pregnancy
* Active collagen vascular disease or patients genetically predisposed to increased radiation related side effects

Primary outcomes:
measure: Local control rate
timeFrame: Approximately 2 years
Secondary outcomes:
measure: Complication rate
timeFrame: Approximately 2 years
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
Study officials:
affiliation: Vanderbilt Medical Center
name: Eric Shinohara, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06944808: Impact of Blood Flow Restriction and Electrical Stimulation on Postoperative Muscle Atrophy and Pain After Total Knee Arthroplasty
Official title: Impact of Blood Flow Restriction and Electrical Stimulation on Postoperative Muscle Atrophy and Pain After Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis Knees
Lead sponsor: University Hospital, Bonn
Sponsor class: OTHER
First posted: 2025-04-25
Enrollment: 20
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 investigate the impact of Blood Flow Restriction Training and Electrostimulation Training on postoperative muscle atrophy and pain after elective total knee arthroplasty.

Detailed description: The present study invesigate the impact of passive blood flow restriction training and/or electrical stimulation training on postoperative muscle atrophy and pain after elective total knee arthroplasty.

Eligibility criteria: Inclusion Criteria:

* Indication for elective total knee arthroplasty
* Understanding of the study and ability for informed consent

Exclusion Criteria:

* Open wounds of the lower extremities
* Stents or bypasses on the location of pressure application
* Sickle Cell Anemia

Primary outcomes:
measure: Postoperative Pain
timeFrame: Pre- to 6 week Post-OP
measure: Muscle Mass
timeFrame: Pre- to 6 week Post-OP
Secondary outcomes:
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: University Hospital Bonn
state: NRW
Study officials:
References:
Clinical trial NCT01306708: Amitriptyline Regarding Nimesulide in Acute Idiopathic Adhesive Capsulitis
Official title: Comparative Study Between Amitriptyline Regarding Nimesulide Associated to Nervous Blockade in the Acute Treatment of Idiopathic Adhesive Capsulitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Adhesive Capsulitis
Keywords: Adhesive Capsulitis
Shoulder
SPADI
Lead sponsor: Universidade do Sul de Santa Catarina
Sponsor class: OTHER_GOV
First posted: 2011-03-02
Enrollment: 34
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 adhesive capsulitis is a disease of the shoulder characterized by pain and limitation of movement amplitude. It is defined as for etiology, having discordant theories that related it to an inflammatory condition or to an algoneurodystrophy process. There is not yet a consensus about the best option of treatment. The non-steroidal anti-inflammatories have analgesic and anti-inflammatory activity, where the mechanism of action is the inhibition of prostaglandin synthesis. The antidepressants have been increasingly used in the control of chronic pain and the major action mechanism to have the analgesic effect seems to be based on inhibition of neurotransmitters reuptake noradrenaline and/or serotonin) in nerve cell endings. Literature studies associate the practice of the nerve suprascapular blockade with anaesthetics to good results of clinical improvement of the pain, however, so far, no clinical studies comparing the efficacy of the non-steroidal antiinflammatories or tricyclic antidepressants to nervous blockage were registered in the acute treatment of adhesive capsulitis.


Eligibility criteria: Inclusion Criteria:

* Patients with clinical diagnostic of adhesive capsulitis, phase II, presenting shoulder pain,
* Limitation of anterior elevation for up to 130 degrees,
* Intact rotator cuff to magnetic resonance,
* Minimum loss of 50% of external rotation when compared to the contralateral side.
* Patients' acceptance of take part in the study after signing the FCCT.

Exclusion Criteria:

* Incapacity to fill the evaluation instrument;
* Contraindication to the use of local anaesthetics, non-steroidal anti-inflammatories or tricyclic antidepressants.
* Pregnancy and breastfeeding.
* Not follow the orientations during treatment on the weeks included in the study, such as, using other anaesthetics or procedures for the relief of pain in this period.
* Lesion of the rotator cuff, infection and others arthropathies.
* Inability to fill a protocol.
* Previous surgery on the shoulder.

Primary outcomes:
measure: Pain and disability of the shoulder
timeFrame: Days 0 and 14 after treatment begining
Secondary outcomes:
Other outcomes:
Locations:
city: Tubarão
country: Brazil
facility: Universidade do Sul de Santa Catarina
state: Santa Catarina
Study officials:
affiliation: Universidade do Sul de Santa Catarina
name: Anna P Piovezan, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01072708: Determination of the Predictive Factors in the Reversibility or the Aggravation in the Disorders of the Glucose Metabolism in Cystic Fibrosis Patients
Official title: Determination of the Predictive Factors in the Reversibility or the Aggravation in the Disorders of the Glucose Metabolism in Cystic Fibrosis Patients (Study DIAMUCO)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes in Cystic Fibrosis Patients
Keywords: Cystic fibrosis -diabetes - glucose tolerance - reversibility - oral glucose tolerance test - predictive factors
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2010-02-22
Enrollment: 230
Sex: ALL
Minimum age (years): 10
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: For some years, the investigators observe an increase of the arisen of diabetes in cystic fibrosis patients However, this diabetes may be reversible. The investigators speak about " Cystic fibrosis related diabetes.". The objective of this project, is to know better what facilitates the appearance and the reversibility of the diabetes, such as the genetic mutations, the respiratory state and the lung infections. Theses knowledges should allow to adapt the screening of diabetes, and its treatment, for the patients affected by cystic fibrosis.


Eligibility criteria: Inclusion Criteria:

* Cystic fibrosis patients with at least one visit in Cystic fibrosis Center in Rhône-Alpes (France) during the second half-year 2008
* Patients with disorders or not of the glucose metabolism
* Patient with pancreatic insufficiency

Exclusion Criteria:

* Patient with hypoglycemia treatment : insulin or oral antidiabetic
* Patient with an age \< 10 years
* Patient with lung transplant

Primary outcomes:
measure: Describe the natural history of the glucose tolerance in cystic fibrosis patients and to identify the predictive factors of the reversibility or the aggravation in the disorders of the glucidic metabolism.
timeFrame: 3 years
Secondary outcomes:
measure: Estimate prevalence of the various stages of disorders of the glucose metabolism : glucose intolerance and diabetes
timeFrame: 3 years
measure: Estimate the probability of arisen the complications associated to the disorders of the glucidic metabolism : - deterioration of the respiratory function, - lung exacerbations - alteration of the nutritional state
timeFrame: 3 years
Other outcomes:
Locations:
city: Pierre Bénite
country: France
facility: Service de Médecine Interne - Centre Hospitalier Lyon Sud
Study officials:
References:
citation: Reynaud Q, Rabilloud M, Roche S, Poupon-Bourdy S, Iwaz J, Nove-Josserand R, Blond E, Laville M, Llerena C, Quetant S, Reix P, Touzet S, Durieu I. Glucose trajectories in cystic fibrosis and their association with pulmonary function. J Cyst Fibros. 2018 May;17(3):400-406. doi: 10.1016/j.jcf.2017.09.010. Epub 2017 Oct 14.
Clinical trial NCT04429308: PDT vs Peels for Treatment of Actinic Keratoses
Official title: PDT Versus the Combination of Jessner's Solution and 35% TCA for Treatment of Actinic Keratoses on Upper Extremities: A Randomized Controlled Split-arm Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Actinic Keratoses
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2020-06-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to to compare photodynamic therapy (PDT) versus the combination of Jessner's solution and 35% trichloroacetic acid (TCA) chemical peels for the treatment of actinic keratoses on upper extremities.

This is a randomized clinical trial. Approximately 60 participants with actinic keratoses on both upper arms will be randomized to have one arm receive photodynamic therapy, while the contralateral arm receives Jessner's solution followed immediately by 35% TCA. AKs will be counted before treatment and 2-8 weeks after treatment. This study is a pilot study designed to determine the feasibility of this procedure.

Subjects currently living in the Chicago metropolitan area and meet inclusion/exclusion criteria will be considered for enrollment.


Eligibility criteria: Inclusion Criteria:

1. \>18 years of age
2. Interested in receiving treatment for actinic keratoses on the bilateral upper arms
3. In good general health as assessed by the investigator
4. Participants must have the ability to understand and the willingness to sign a written informed consent prior to registration on study

Exclusion Criteria:

1. Patient pregnant or nursing
2. Patient with extensive concurrent skin conditions (such as eczema, psoriasis, etc) on upper extremities that would interfere with treatment as determined by the treating physician
3. Subject unwilling to sign an IRB approved consent form
4. Participants who are unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function are not eligible

Primary outcomes:
measure: Percentage of total AKs cleared
timeFrame: 2-8 weeks after treatments
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Department of Dermatology
state: Illinois
Study officials:
affiliation: Northwestern University
name: Murad Alam, MD
role: PRINCIPAL_INVESTIGATOR
References: