louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05875350: Intraligamental Local Anesthesia Versus Infiltration Technique for Extraction of Grade II Mobility Maxillary Molars
Official title: Efficacy of Low Dose Intraligamental Local Anesthesia as an Alternative for Infiltration Technique for Extraction of Grade II Mobility Maxillary Molars: Double Blind Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia, Local
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2023-05-25
Enrollment: 60
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: The study aims to assess the use of intraligamental local anesthetic injection compared to buccal infiltration for extraction of maxillary molars suffering grade II mobility in terms of pain control and extraction duration.


Eligibility criteria: Inclusion Criteria:

* healthy patients (class I category according to American society of anesthesiologists )
* Age range: 20 - 60 years of age,
* Either genders who are seeking dental extraction of maxillary molar teeth diagnosed with grade II mobility.

Exclusion Criteria:

* Patients with tooth that require trans osseous extraction
* Badly broken down coronal structure of the tooth to be extracted
* Patients with significant medical conditions
* Alcoh intake
* Patients on drugs that affect the central nervous systems
* Patients who reported the use of drugs that might interfere with pain sensitivity
* Pregnant or lactating women
* Patients who suffer from hypersensitivity to local anesthetics or non-steroidal anti-inflammatory drugs (NSAIDs).

Primary outcomes:
measure: Pain using visual analogue scale
timeFrame: immediately after injection
Secondary outcomes:
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Faculty of Dentistry, Minia University
Study officials:
References:
Clinical trial NCT06049550: The Influence of the Thickening of Bowman's Capsule on the Clinical Prognosis of Patients With Diabetic Kidney Disease
Official title: The Influence of the Thickening of Bowman's Capsule on the Clinical Prognosis of Patients With Diabetic Kidney Disease
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Diabetic Kidney Disease
Extracellular Matrix Alteration
Keywords: Diabetic Kidney Disease
extracellular matrix
parietal epithelial cells
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2023-09-22
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosised as diabetic kidney disease by renal biopsy from January 1, 2017 to December 31, 2021 in Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine, the First Affiliated Hospital of China Medical University, Shanghai Sixth People's Hospital and Shanghai General Hospital.

Brief summary: Diabetic kidney disease (DKD) is the leading cause for renal replacement therapy in developed country. DKD is also the primary cause of ESKD among middle-aged and elderly people in China. Renal pathological markers have been proved to have clinical and prognostic value in both non diabetic and diabetic kidney diseases. To discriminate lesions by various degrees of severity, the Working Group of the Renal Pathology Society (RPS) developed a pathologic classification for DKD in 2010. The classification is based on glomerular lesions, with a separate evaluation for interstitial and vascular lesions. In a decade, there were several new characteristics common to DKD, such as the presence of mesangiolysis, glomerular hyalinosis, segmental sclerosis and extracapillary hypercellularity, which have been noted in patients with diabetes and may have prognostic importance. But it is still unclear whether thickening of Bowman's capsule predicts the progression of DKD.


Eligibility criteria: Inclusion Criteria:

* 1) Age ≥ 18 years old, male or female 2) Patients diagnosed as diabetes kidney disease by renal biopsy

Exclusion Criteria:

* 1) Patients combined with non diabetes kidney disease; 2) Patients with kidney transplant failure; 3) Patients undergoing zero point puncture for kidney transplantation; 4) less than 5 glomeruli in the renal puncture sample.

Primary outcomes:
measure: renal failure
timeFrame: From the diagnosis of diabetes kidney disease by renal biopsy to December 31, 2022
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00948350: Anesthesia for Awake Fiberoptic Intubation
Official title: Anesthesia for Awake Fiberoptic Intubation in Patients With Cervical Instability - Comparison of Translaryngeal Injection and "Spray as You go"-Technique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation
Keywords: cervical instability
awake intubation
laryngeal anesthesia
Lead sponsor: Klinikum St. Georg gGmbH
Sponsor class: OTHER
First posted: 2009-07-29
Enrollment: 120
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 prospective, comparative, randomized, monocentric, clinical open study, to compare two anesthesia techniques (translaryngeal injection vs. spray as you go) in patients with cervical instability with regard to technical modalities and quality of fiberoptic awake intubation.

Detailed description: In patients with cervical instability anesthesia induction and conventional intubation are associated with the risk of neurological harm. Therefore the method of choice for anesthesia induction is the fiberoptic awake intubation. This method allows to place the ventilation tube without movement of the cervical spinal cord. This procedure is very uncomfortable for the patient and needs the application of topic and/or systemic anesthetics.

With this clinical study we will compare two established techniques for local laryngeal anesthesia with regard to the quality of technical modalities and postoperative outcome.

Eligibility criteria: Inclusion Criteria:

* patients with cervical instability undergoing elective decompression of cervical spine

Exclusion Criteria:

* patient refused participation
* contraindications for awake intubation techniques (e.g. nasal bleeding, anatomical disorders)
* patient under alcohol or drugs
* emergency surgery

Primary outcomes:
measure: patients satisfaction with anesthesia
timeFrame: up to two weeks after hospital admission
Secondary outcomes:
measure: pain after anesthesia
timeFrame: Change from Baseline in pain after anesthesia at end of hospital stay
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: Klinikum St. Georg gGmbH
state: Sachsen
Study officials:
affiliation: Clinics of Anesthesiology, Critical care and Pain Therapy
name: Armin R Sablotzki, MD
role: STUDY_CHAIR
affiliation: Clinic of Anesthesiology, Dept. Neuroanesthesia and Neuromonitoring
name: Michael Malcharek, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Malcharek MJ, Bartz M, Rogos B, Gunther L, Sablotzki A, Gille J, Schneider G. Comparison of Enk Fibreoptic Atomizer with translaryngeal injection for topical anaesthesia for awake fibreoptic intubation in patients at risk of secondary cervical injury: A randomised controlled trial. Eur J Anaesthesiol. 2015 Sep;32(9):615-23. doi: 10.1097/EJA.0000000000000285.
Clinical trial NCT02487550: DC Vaccine Therapy Combined With Cytokine-Induced Killer Cell in Treating
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Renal Neoplasma
Keywords: Renal neoplasma
CIK cells
Lead sponsor: The First People's Hospital of Changzhou
Sponsor class: OTHER
First posted: 2015-07-01
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
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 this study is to show if vaccination with autologous dendritic cells pulsed with tumor lysate in combination with Cytokine-Induced Killer Cell (CIK) can induce a measurable immune response in patients with renal cell carcinoma, and to evaluate the clinical effect of the regimen.

Detailed description: The purpose of this study is to show if vaccination with autologous dendritic cells pulsed with tumor lysate in combination with Cytokine-Induced Killer Cell (CIK) can induce a measurable immune response in patients with renal cell carcinoma, and to evaluate the clinical effect of the regime.

Primary

1. Determine the clinical responses(objective response, progression-free survival, and overall survival) in patients with renal cell carcinoma treated with autologous dendritic cells (DC) loaded with autologous tumor lysate (DC vaccine) in combination with Cytokine-Induced Killer Cell (CIK).

Secondary

1. Determine cellular immune response response in terms of immuknow assay, and correlate immune response with objective clinical response in patients treated with this regimen.
2. Determine safety of multiple administrations of this regimens in these patients.

Eligibility criteria: Inclusion Criteria:

* Histologically proven renal cell carcinoma
* Age: \> 18
* WHO- ECOG Performance Status 0-1
* At least one measurable tumor lesions according to the RECIST criteria.
* Life expectancy more than 3 months
* Written informed consent

Exclusion Criteria:

* Patients with a history of any other neoplastic disease less than 5 years ago (excepting treated carcinomas in situ of the cervix and basal/squamous cell carcinomas of the skin).
* Patients with metastatic disease in the central nervous system (CNS).
* Patients with other significant illness including severe allergy, asthma, angina pectoris or congestive heart failure.
* Patients with acute or chronic infection including HIV.
* Patients who are pregnant or nursing.
* Patients who have received antineoplastic therapy including chemotherapy or immunotherapy less than 4 weeks before beginning the trial.
* Patients who receive corticosteroids or other immunosuppressive agents.
* Patients with active autoimmune diseases such as lupus erythematosus, rheumatoid arthritis or thyroiditis.

Primary outcomes:
measure: Progression-free time
timeFrame: 3 months
measure: Overall-survival time
timeFrame: 3 months
Secondary outcomes:
measure: Objective tumor response
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01446250: Alisporivir (Deb025) and Boceprevir Triple Therapies in African American Participants Not Previously Treated for Chronic Hepatitis C Genotype 1
Official title: A Randomized, Open Label Trial of the Safety and Efficacy of DEB025/Alisporivir in Combination With Pegylated Interferon-α2a and Ribavirin (Peg-INFα2a/RBV) and Boceprevir in Combination With Peg-INFα2a/RBV in African American Treatment-naïve Patients With Chronic Hepatitis C Genotype 1
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Hepatitis C
Keywords: Chronic hepatitis C
Cyclophilin inhibitor
Lead sponsor: Debiopharm International SA
Sponsor class: INDUSTRY
First posted: 2011-10-05
Enrollment: 8
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: This study will assess the safety and efficacy of alisporivir (ALV) and boceprevir (BOC), each in combination with Peginterferon alfa-2a (PEG) and Ribavirin (RBV), in African American participants who have never received treatment for their chronic hepatitis C (HCV) genotype 1 infection.


Eligibility criteria: Inclusion criteria:

* Chronic HCV genotype 1 infection
* No previous treatment for HCV infection
* African American ethnicity
* Serum HCV RNA ≥ 1000 IU/ml, assessed by quantitative polymerase chain reaction or equivalent at screening visit, no upper limit
* A liver biopsy within 3 years prior to baseline

Exclusion criteria:

* HCV genotype different from genotype 1 or co-infection with other HCV genotype
* Co-infection with Hepatitis B or HIV
* Any other cause of relevant liver disease other than HCV
* Presence or history of hepatic decompensation
* Alanine aminotransferase (ALT) ≥ 10 times ULN, more than 1 episode of elevated bilirubin (\> ULN) in past 6 months

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Percentage of Participants That Discontinued Study Drug or Required Dose Reduction or Dose Interruption Due to Treatment-emergent Adverse Events
timeFrame: within 48 weeks
Secondary outcomes:
measure: Percentage of Participants With Emergence of Resistant Mutations
timeFrame: within 48 weeks
measure: Percentage of Participants Who Achieved Sustained Virologic Response (SVR) 24 Weeks After the End of Treatment (SVR24)
timeFrame: 24 weeks post-treatment
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Novartis Investigational Site
state: California
city: Baltimore
country: United States
facility: Novartis Investigational Site
state: Maryland
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT04836650: Effect of Postural Insoles on Stability and Leg Muscular Activity
Official title: Effect of Postural Metatarsal Bar Orthotic Element on Stability and Leg Muscular Activity. A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postural Stability
Muscular Activity
Keywords: Metatarsal Bar
Insoles
Postural stability
Electromyograph Activity
Lead sponsor: Universidad de Extremadura
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Posturology allows to treat postural problems by using postural insoles, which will have an effect at the neurophysiological level. Pieces of 1 to 3 millimeters are inserted to stimulate specific receptors located on the sole of the foot, which will affect the muscular proprioception and modify the activation of the ascending muscle chains.

The hypothesis of this work is based on the fact that the use of postural insoles with a 2 millimeters metatarsal bar will influence the displacement of the center of pressure and the muscle activity of the leg when compared with a placebo insoles.

Participants will be healthy subjects and will be divided into two groups, control and experimental. Subjects in the control group will be given a pair of flat insoles (placebo insoles) with 1.2 millimeters polyester resin. Those of the experimental group will be made the same insoles but they will include by thermal fusion a metatarsal bar of 2 millimeters polyester resin in the metatarsal zone corresponding to the 1st, 2nd, 3rd and 4th metatarsal head.

Postural stability analysis will be performed with the force platform of the Biomechanics Institute of Valencia (IBV-Spain) and at the same time an electromyographic analysis in the dominant leg with a surface electromyograph system. Subjects will be assessed with their eyes open and closed under two situations, with footwear and with footwear and insoles.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects with no discomfort in gait
* Subjects with not muscle and skeletal diseases

Exclusion Criteria:

* Subjects with balance disorders, pain at legs
* Subjects with loss of balance

Primary outcomes:
measure: Change of postural balance
timeFrame: From baseline to 10 minutes
measure: Change of muscular activity
timeFrame: From baseline to 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Plasencia
country: Spain
facility: Alfonso Martínez Nova
state: Cáceres
Study officials:
References:
Clinical trial NCT04376450: Nonincised Papillae in the Treatment of Intrabony Defects.
Official title: A Comparative Evaluation of Nonincised Papillae and Entire Papilla Preservation Surgical Approach in the Treatment of Intrabony Defects - a Clinical and Radiographic Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Reconstructive Surgical Procedure
Keywords: Periodontitis; reconstructive surgical procedure;
guided tissue regeneration;
surgical flaps;treatment outcome
Lead sponsor: SVS Institute of Dental Sciences
Sponsor class: OTHER
First posted: 2020-05-06
Enrollment: 34
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: GROUP A: NONINCISED PAPILLAE SURGICAL APPROACH (NIPSA) GROUP B: ENTIRE PAPILLA PRESERVATION TECHNIQUE (EPP)
Primary purpose: TREATMENT

Brief summary: The primary objective of the present study is to clinically and radiographically evaluate nonincised papillae surgical approach and entire papilla preservation approach for the treatment of intrabony defects with GTR membrane and hydroxyapatite graft.

Detailed description: Various procedures to treat intrabony defects by preserving the interdental papilla include conventional, simplified, and modified papilla preservation techniques. The drawback of these techniques is the post-surgical gingival recession.

In order to overcome this drawback, the "entire papilla preservation" technique has been proposed, by preserving the whole integrity of the defect associated papilla providing a tunnel-like undermining incision. Recently a novel surgical procedure, termed nonincised papillae surgical approach (NIPSA), was designed to maintain the integrity of the interdental soft tissues covering intrabony defects. This would prevent biomaterial exposure associated with loss of papillary height, increase the amount of space for hard and soft tissue regeneration, and minimize gingival recession.

Eligibility criteria: Inclusion Criteria:

1. Systemically healthy individuals within an age group 30-60yrs with chronic periodontal disease.
2. Presence of two or more intrabony defects with probing pocket depth ≥5mm, CAL≥5mm, and radiographic depth ≥4mm.
3. Adequate attached gingiva of 3mm and vestibular depth of 8mm. -

Exclusion Criteria:

1. Uncontrolled systemic disease.
2. Pregnancy and lactation.
3. Defects involving lingual sites.
4. Presence of restoration in the experimental teeth.
5. Smokers -

Primary outcomes:
measure: CLINICAL ATTACHMENT LEVEL (CAL)
timeFrame: Baseline to 6 months
measure: POCKET PROBING DEPTH (PPD)
timeFrame: Baseline to 6 months
measure: Intrabony component (INTRA) of the defect
timeFrame: Baseline to 6 months
Secondary outcomes:
measure: Papilla loss (PL)
timeFrame: Baseline to 6 months
measure: Local bleeding score
timeFrame: Baseline to 6 months
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: R V Chandra
state: Telangana
Study officials:
References:
Clinical trial NCT03157050: Intravenous Iron May Increase Depression Among Hemodialysis Patients
Official title: Intravenous Iron May Increase Depression Among Hemodialysis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression
Hemodialysis Complication
Iron Deficiency Anemia
Lead sponsor: Benha University
Sponsor class: OTHER
Collaborators: name: New Jeddah Clinic Hospital
First posted: 2017-05-17
Enrollment: 112
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hemodialysis patients with iron deficiency anemia.

Brief summary: the aim of this study is to assess whether increased ferritin after intravenous iron therapy will lead to increased prevalence of major depression among treated patients.


Eligibility criteria: Inclusion Criteria:

1. age was above 19 years,
2. patient on maintenance hemodialysis,
3. patient had iron deficiency anemia (ferritin \> 100 ng/ml)

Exclusion Criteria:

1. patient has history of depression or already using antidepressant medication,
2. Lack of ferritin level increase ≥ 50% from baseline level before IV iron administration,
3. patient already on oral or intravenous iron supplement

Primary outcomes:
measure: Change in patient health questionnaire-9 score
timeFrame: on day 0 of start of intravenous iron and 1 week after completion of intravenous iron
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Benha University
name: Mahmoud Hamada, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02816450: Water Intervention for Thinking in Kids (WITiKids ) Study
Official title: The Effects of Hydration on Brain, Cognition, Memory & Achievement in Childhood
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Fluid Intake, Chronic
Keywords: Water
Children
Cognition
Hydration
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
Collaborators: name: Danone Global Research & Innovation Center
First posted: 2016-06-28
Enrollment: 30
Sex: ALL
Minimum age (years): 9
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The aim of this study is to determine the influence of changes in water intake on changes in cognitive function among preadolescent children. Further, the proposed work will determine the relationship between urinary markers of hydration process and cognitive function. We hypothesize that an increase in water intake will result in greater cognitive performance. In addition, improvements in hydration demonstrated by lower urine concentration will be correlated with greater cognitive performance.


Eligibility criteria: Inclusion Criteria:

1. Parental/guardian consent
2. Normal or corrected-to-normal vision based on the minimal 20/20 standard in order to complete the cognitive task (below 20/20 vision).

Exclusion Criteria:

1. Participants younger than 9 years and older than 10 years at the time of testing age.
2. Prior diagnosis of cognitive or physical disability, including ADHD (severe asthma, epilepsy, chronic kidney disease, and dependence upon a wheelchair/walking aid).
3. Use of anti-psychotic, anti-depressant, anti-anxiety medication, as well as those medications used for ADD/ADHD (use of any anti-psychotic, anti-depressant, anti-anxiety, and ADD/ADHD medications).
4. Participants must have not yet reached, or be in the earliest stages, of puberty, as measured by a modified test of the Tanner Staging System
5. IQ below 85
6. Use of medications that alter urinary excretion and water metabolism
7. Use of internal electronic device, such as a pacemaker

Primary outcomes:
measure: Flanker Task Accuracy
timeFrame: 2 Hours on the morning of Day 5
Secondary outcomes:
measure: Urine Osmolality
timeFrame: 24 hours during final day of fluid intake modulation (Day 4)
Other outcomes:
Locations:
city: Urbana
country: United States
facility: Department of Kinesiology and Community Health
state: Illinois
Study officials:
References:
citation: Khan NA, Westfall DR, Jones AR, Sinn MA, Bottin JH, Perrier ET, Hillman CH. A 4-d Water Intake Intervention Increases Hydration and Cognitive Flexibility among Preadolescent Children. J Nutr. 2019 Dec 1;149(12):2255-2264. doi: 10.1093/jn/nxz206.