louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03593265: MUNIX Variability in Healthy Subjects
Official title: Calculation of Normal MUNIX Variation in an Healthy Population
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2018-07-20
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Motor unit number index (MUNIX) is an electrophysiological technique that estimates the number of motor units in a muscle. This data can be changed by natural evolution or by treatment in peripheral neuropathy. Alfortunately, normal value for MUNIX variation does not exist. Thus, it is difficult to assume improvement or worsening of the MUNIX for an individual subject.

Our objective is to calculate normal variation of MUNIX in 4 muscles : tibialis anterior, abductor digiti mini, abductor pollicis brevis et deltoideus. Measurement will be performed at inclusion and 3 monthes later in 100 healthy subjects. This trial will be prospective in several French centres sepecialized in neuromuscular evaluation

Detailed description: Motor unit number index (MUNIX) is an electrophysiological technique that estimates the number of motor units in a muscle. This data can be changed by natural evolution or by treatment in peripheral neuropathy. Alfortunately, normal value for MUNIX variation does not exist. Thus, it is difficult to assume improvement or worsening of the MUNIX for an individual subject.

Our objective is to calculate normal variation of MUNIX in 4 muscles: tibialis anterior, abductor digiti mini, abductor pollicis brevis et deltoideus. Measurement will be performed at inclusion and 3 monthes later in 100 healthy subjects. This trial will be prospective in several French centres sepecialized in neuromuscular evaluation

Eligibility criteria: Inclusion Criteria:

* Healthy subjects without neuromuscular disoreders or others diseases which can interfer with MUNIX measurement
* More than 18 years old

Exclusion Criteria:

* Less than 18 years old
* Diseases which can interfer with MUNIX measurement

Primary outcomes:
measure: MUNIX
timeFrame: 3 months
Secondary outcomes:
measure: MUSIX
timeFrame: 3 months
measure: CMAP amplitudes
timeFrame: 3 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Des Hopitaux de Marseille
state: Paca
Study officials:
affiliation: APHM
name: EMILIE GARRIDO PRADALIE
role: STUDY_DIRECTOR
References:
Clinical trial NCT05188365: Acupuncture Efficacy on Lipids in Tinnitus Patients With Obesity
Official title: Acupuncture Efficacy on Lipids in Tinnitus Patients With Obesity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tinnitus, Subjective
Obesity
Lipids
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-01-12
Enrollment: 60
Sex: ALL
Minimum age (years): 35
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: nowadays, published literature affirms strong relation between tinnitus, obesity, and high lipids of blood.

Detailed description: For 8 weeks, our study will search effect of acupuncture on tinnitus (chronic subjective type), lipids and weight reduction in obese persons.

Eligibility criteria: Inclusion Criteria:

* obese patients
* tinnitus complaints (chronic subjective form)

Exclusion Criteria:

* diabetics
* cardiovascular and neurogenic manifestations

Primary outcomes:
measure: tinnitus handicap inventory
timeFrame: It will be measured after eight weeks of acupuncture
Secondary outcomes:
measure: cholesterol
timeFrame: It will be measured after eight weeks of acupuncture
measure: triglycerides
timeFrame: It will be measured after eight weeks of acupuncture
measure: high density lipoprotein
timeFrame: It will be measured after eight weeks of acupuncture
measure: low density lipoproetin
timeFrame: It will be measured after eight weeks of acupuncture
measure: body mass index
timeFrame: It will be measured after eight weeks of acupuncture
measure: waist circumference
timeFrame: It will be measured after eight weeks of acupuncture
measure: visual analogue scale
timeFrame: It will be measured after eight weeks of acupuncture
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo Unoversity
Study officials:
affiliation: Cairo University
name: Ali Ismail, lecturer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01326065: Implementation of Laparoscopy-assisted Surgery for Colon Cancer
Official title: Implementation of Laparoscopy-assisted Surgery for Colon Cancer. A Prospective Population-based Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Colon Cancer
Lead sponsor: Helse Stavanger HF
Sponsor class: OTHER_GOV
First posted: 2011-03-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients submitted for curative resection of colon cancer to the Dept. of Surgery, Stavanger University Hospital. Catchment area of the hospital consists of a population of 300.000 inhabitants, with Stavanger UH as the only institution with surgical service

Brief summary: The purpose of this study is to study the implementation of laparoscopy-assisted surgery for cure of colon cancer in daily surgical practice.

Detailed description: Prospective observational study of laparoscopy-assisted surgery for resectable colon cancer with regard to short term and long term outcomes

Eligibility criteria: Inclusion Criteria:

* Age \>17 years
* diagnosis of colon cancer either endoscopically, radiologically or histologically proven
* No evidence of disseminated disease on CT scan
* T1-3 according to preoperative CT scan
* written informed consent to participate

Exclusion Criteria:

* preoperative diagnosis of locally advanced tumor (T4)
* suspicion of pathological lymph nodes outside anticipated resection area
* contraindications against laparoscopic surgery, e.g. known bowel adhesions, anesthesiological concerns
* lack of informed consent

Primary outcomes:
measure: Long term outcome
timeFrame: 5 years
Secondary outcomes:
measure: Complications related to the surgical procedure
timeFrame: 30 days
measure: Quality of life
timeFrame: 1 year
measure: Quality of the surgical specimen
timeFrame: 14 days
Other outcomes:
Locations:
city: Stavanger
country: Norway
facility: Stavanger University Hospital
Study officials:
affiliation: Helse Stavanger HF
name: Hartwig Kørner, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Helse Stavanger HF
name: Jens Christian Knapp, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03653065: Assiut University Children Hospital Egypt
Official title: Assiut University Children Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mechanical Ventilation Outcomes
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-08-31
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: CASE_CROSSOVER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Data will be extracted from the files of the patients

Brief summary: Frequency and outcomes of mechanical ventilation In intensive care unit at Assiut university children hospital.

Detailed description: Data will be extracted from the files of the patients which will include the following:

History Examination Investigations Cause of mechanical ventilation (status epilepticus,respiratory failure and other) First attempt success rate

Eligibility criteria: Inclusion Criteria:

* Patients who are mechanically ventilated
* age:One month to 18 years.
* sex:both male and female
* duration:for one year
* type of the study:retrospective
* site :intensive care unit at Assiut university children hospital

Exclusion Criteria:

* patients who are intubated outside Assiut university children hospital.

Primary outcomes:
measure: Frequency of endotracheal intubation
timeFrame: one year
measure: First attempt success rate
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Nora
Study officials:
References:
Clinical trial NCT01729065: A Study to Assess the Efficacy of Early Physical Therapy Intervention Following a Modified Unilateral Neck Dissection for Treatment of Head and Neck Cancer
Official title: A Randomized Study to Assess the Efficacy of Early Physical Therapy Intervention on Upper Quarter Strength and Mobility, and Reported Upper Extremity Disability and Quality of Life Measures Following a Modified Unilateral Neck Dissection for Treatment of Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Weakness Following Neck Dissection Surgery
Keywords: Spinal Accessory Nerve Palsy, Cranial Nerve XI, shoulder weakness, neck stiffness, head and neck cancer, neck dissection
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2012-11-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will determine whether patients who receive regular physical therapy immediately following a modified neck dissection surgery will report decreased shoulder disability, decreased pain, improved or maintained shoulder range of motion and strength, and improved quality of life than those who receive only home instruction.


Eligibility criteria: Inclusion Criteria:

* Adults age 18-85, able to give informed consent
* Subject has provided written informed consent
* Received Modified Unilateral Neck Dissection with sparing of the SAN
* Not currently using transcutaneous electrical nerve stimulation (TENS) as a pain relieving modality
* Not currently receiving acupuncture as a pain relieving modality
* Able to participate with treatment group protocol including physical therapy appointment every other week

Exclusion Criteria:

* History of prior shoulder injury or surgery including rotator cuff repair or total shoulder arthroplasty.
* History of CVA with hemi paresis
* Bilateral neck dissection
* Known severed SAN

Primary outcomes:
measure: Disability of the Arm Shoulder and Hand
timeFrame: 12, 24, 36 weeks
Secondary outcomes:
measure: SF-36
timeFrame: 12, 24, 36 weeks
Other outcomes:
measure: Visual Analog Scale
timeFrame: 12, 24, 36 weeks
measure: Strength, range of motion of the neck and shoulder
timeFrame: 12, 24, 36 weeks
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Melissa M Eden, PT, DPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03935074: Superselective Intra-arterial Chemotherapy Treatment for Retinoblastoma- 5 Year Results From Turkey
Official title: Superselective Intra-arterial Chemotherapy Treatment for Retinoblastoma- 5 Year Results From Turkey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Retinoblastoma
Keywords: enucleation
globe salvage
superselective intra-arterial chemotherapy
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2019-05-02
Enrollment: 30
Sex: ALL
Minimum age (years): 5
Maximum age (years): 7
Standard ages: CHILD
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with retinoblastoma and who received superselective intra-arterial chemotherapy as a first line treatment or as a salvage treatment after systemic chemotherapy

Brief summary: Retrospective review of 5-year long term outcomes of superselective intra-arterial chemotherapy treatment in retinoblastoma in a single institute.

The treatment outcomes, globe salvage rates and complications of superselective intra-arterial chemotherapy both for treating naive patients (primary treatment group) and for patients who received systemic chemotherapy previously (secondary treatment group) were evaluated.


Eligibility criteria: Inclusion Criteria:

* patients diagnosed with unilateral/bilateral retinoblastoma

Exclusion Criteria:

* patients with trilateral retinoblastoma
* extraoculer involvement
* patients with blood dyscrasias, bleeding and clotting disorders

Primary outcomes:
measure: globe salvage
timeFrame: 2-5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpasa School of Medicine Ophthalmology Department
Study officials:
References:
citation: Saglam M, Sarici A, Anagnostakou V, Yildiz B, Kocer N, Islak C, Kizilkilic O. An alternative technique of the superselective catheterization of the ophthalmic artery for intra-arterial chemotherapy of the retinoblastoma: retrograde approach through the posterior communicating artery to the ophthalmic artery. Neuroradiology. 2014 Sep;56(9):751-4. doi: 10.1007/s00234-014-1388-1. Epub 2014 Jun 10.
Clinical trial NCT01523574: Vitamin E for Oxaliplatin-induced Peripheral Neuropathy Prophylaxis
Official title: Randomized, Placebo Controlled Study of Vitamin E for Oxaliplatin-induced Neuropathy Prophylaxis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Peripheral Neuropathy
Keywords: oxaliplatin
vitamin e
neuropathy
peripheral
prophylaxis
Lead sponsor: Faculdade de Medicina do ABC
Sponsor class: OTHER
First posted: 2012-02-01
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Introduction: Oxaliplatin (Ox) is a frequently used platinum-based medication that is a part of many chemotherapy regimens for the treatment of several gastrointestinal malignancies. One of the most important limitations to its use is the induction of both acute and chronic peripheral neuropathy (PN). Previous studies have shown that vitamin E can reduce the incidence of cisplatin-induced PN by 50%. In this study, the investigators aimed to determine if vitamin E could also prevent Ox-induced acute PN

Detailed description: This was a prospective, phase II, randomized pilot study. Patients were randomized 5 days before the start of Ox to receive either vitamin E at 400 mg daily or placebo, until after the end of the Ox-based chemotherapy regimen. The investigators evaluated PN intensity using the CTCAE version 3 and specific Ox PN gradation scales. The investigators included patients with colorectal and gastric cancers scheduled to receive Ox-based chemotherapy. Both groups received calcium and magnesium supplements before and after oxaliplatin infusions.

Eligibility criteria: Inclusion Criteria:

* ECOG Performance status 0 or 1
* Older than 18 years
* New diagnose with colorectal or gastric cancer
* Scheduled to receive oxaliplatin-based regimens

Exclusion Criteria:

* Excluded patients with a previous history of PN or with symptomatic PN at entry into the study
* Excluded patients who received other chemotherapy regimens (except isolated 5-fluorouracil)
* Patients currently receiving gabapentin, carbamazepine, amitriptyline, amifostine or multivitamins

Primary outcomes:
measure: Incidence and grade of Peripheral neuropathy by common terminology criteria for adverse events v 3.0(CTCAE)and specific Ox PN gradation scales.
timeFrame: Within the first 45 days (plus or minus 7 days) of treatment ( 3 x oxaliplatin infusions)
Secondary outcomes:
Other outcomes:
Locations:
city: Santo Andre
country: Brazil
facility: Faculdade de Medicina do ABC
state: Sao Paulo
city: Santo André
country: Brazil
facility: Faculdade de Medicina do ABC
state: São Paulo
Study officials:
affiliation: Faculdade de Medicina do ABC
name: Auro del Giglio, phD
role: STUDY_DIRECTOR
References:
citation: Afonseca SO, Cruz FM, Cubero Dde I, Lera AT, Schindler F, Okawara M, Souza LF, Rodrigues NP, Giglio Ad. Vitamin E for prevention of oxaliplatin-induced peripheral neuropathy: a pilot randomized clinical trial. Sao Paulo Med J. 2013;131(1):35-8. doi: 10.1590/s1516-31802013000100006.
Clinical trial NCT02371174: Post-Marketing Surveillance Study of Eribulin on the Status and Factors for the Development of Peripheral Neuropathy in Japan.
Official title: An Observational Post-Marketing Surveillance Study on the Status and Factors for the Development of Peripheral Neuropathy in Patients With HER2-Negative Inoperable or Recurrent Breast Cancer in Japan.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
HER2-negative Breast Cancer
Keywords: HER2-Negative Inoperable or Recurrent Breast Cancer
Japan
Eribulin Mesylate
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2015-02-25
Enrollment: 651
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HER2-negative subjects who are treated with HALAVEN for the first time.

Brief summary: The primary objective of the study is to clarify factors affecting the incidence of peripheral neuropathy in patients treated with HALAVEN. A total of 590 patients will be enrolled in this study with 295 patients in the treatment group of primary or secondary chemotherapy and 295 patients in the treatment group of tertiary or later chemotherapy.


Eligibility criteria: Inclusion criteria:

Patients with HER2-negative inoperable or recurrent breast cancer.

Exclusion criteria:

Patients with high-grade bone marrow depression (absolute neutrophil count less than 1,000 /mm\^3, absolute platelet count less than 75,000 /mm\^3).

Patients with a history of hypersensitivity to the ingredients of HALAVEN. Women who are pregnant or may be pregnant. Patients with a history of use of HALAVEN.

Primary outcomes:
measure: Number of participants with adverse events and serious adverse events
timeFrame: Baseline and up to 2 years after the initial dose of HALAVEN
measure: Number of participants with peripheral neuropathy
timeFrame: Baseline, and every two months after the initial dose of HALAVEN up to 2 years
measure: Number of participants with adverse drug reactions
timeFrame: Baseline and up to 2 years after the initial dose of HALAVEN
measure: Time to onset of peripheral neuropathy
timeFrame: Baseline and up to 2 years after the initial dose of HALAVEN
measure: Time to resolution of peripheral neuropathy
timeFrame: Baseline and up to 2 years after the initial dose of HALAVEN
Secondary outcomes:
measure: Overall survival
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Osaka
country: Japan
city: Tokyo
country: Japan
Study officials:
References:
Clinical trial NCT00002374: A Study of Saquinavir Soft Gelatin Capsules Combined With Other Anti-HIV Drugs in HIV-1 Infected Patients
Official title: A Phase IIIB Open-Label Trial Replacing Saquinavir HGC (Ro 31-8959) With Saquinavir SGC (Ro 31-8959) in Combination With Other Antiretroviral Drugs in Patients With HIV-1 Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Keywords: HIV-1
Drug Therapy, Combination
Acquired Immunodeficiency Syndrome
HIV Protease Inhibitors
RNA, Viral
Saquinavir
Anti-HIV Agents
Viral Load
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 120
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To examine the efficacy of saquinavir SGC (soft gel capsules) in combination with other antiretrovirals in HIV-1 infected patients currently treated with saquinavir HGC (hard gel capsules) measured by the absolute change in plasma HIV-1 RNA during the 24 weeks of study treatment.

Detailed description: Eligible patients will be stratified by HIV-1 RNA level into 2 populations: 1) \>= 5,000-30,000 HIV-1 RNA, 2) \> 30,000 HIV-1 RNA. All patients will be randomized to 1 of 3 treatment arms: Arm A - Saquinavir soft gel capsules (SQV SGC) + 2 new nucleoside analogs (reverse transcriptase inhibitors \[RTIs\]), Arm B - SQV SGC + nelfinavir + stavudine (d4T) or a new RTI, or Arm C - SQV SGC + ritonavir + d4T or a new RTI. All patients will undergo plasma HIV-1 RNA determinations, CD4 lymphocyte counts, hematology and chemistry blood work at baseline, weeks 4, 8, 12, 16 and 24.

Eligibility criteria: Inclusion Criteria

Patients must have:

* Documented HIV infection.
* CD4 \> 100 cells/mm3.
* Saquinavir HGC-experienced patients (\>= 3 months cumulative therapy).

Required:

\>= 3 months cumulative saquinavir HGC therapy.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Pacific Oaks Med Ctr
state: California
city: Los Angeles
country: United States
facility: Tower Infectious Diseases / Med Associates Inc
state: California
city: Coral Gables
country: United States
facility: Community Research Initiative of South Florida
state: Florida
city: Tampa
country: United States
facility: Ctr for Quality Care
state: Florida
city: Brookline
country: United States
facility: Community Research Initiative of New England
state: Massachusetts
city: New York
country: United States
facility: AIDS Ctr
state: New York
city: Pittsburgh
country: United States
facility: Anderson Clinical Research / Inc
state: Pennsylvania
Study officials:
References:
citation: Cadman J. Roche brings new formulation of saquinavir to FDA. Food and Drug Administration. GMHC Treat Issues. 1997 Apr-May;11(4/5):8.
Clinical trial NCT00841074: Chlorhexidine & Pneumonia in Nursing Home Residents
Official title: Effect of Topical Oral Chlorhexidine in Reducing Pneumonia in Nursing Home Residents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pneumonia
Respiratory Infection
Keywords: Pneumonia
Elderly
Chlorhexidine
Respiratory pathogens
Lead sponsor: University of Louisville
Sponsor class: OTHER
Collaborators: name: National Institute of Dental and Craniofacial Research (NIDCR)
First posted: 2009-02-11
Enrollment: 75
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is determine if topical oral application of a chlorhexidine antimicrobial spray will significantly reduce pneumonia and respiratory infections, and improve oral health compared to a placebo solution in nursing home residents.


Eligibility criteria: Inclusion Criteria:

1. Participants must be at least 65 years old.
2. Be dependent in 2 or more Activities of Daily Living as noted on the nursing home resident's Minimum Data Set - One must be ADL J- Personal Hygiene.
3. Have natural teeth and/or wear complete or partial dentures.
4. Expected to be a resident in a nursing home for two years.

Exclusion Criteria:

1. Existing pneumonia.
2. History of chlorhexidine reaction or allergy and/or multiple medication or substance allergies.
3. Receiving chlorhexidine oral application at enrollment as prescribed by physician or dentist.

Primary outcomes:
measure: Pneumonia
timeFrame: 12 months
Secondary outcomes:
measure: Respiratory pathogens
timeFrame: 12 months
measure: Plaque and Gingival Indices
timeFrame: 12 months
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Catherine J Binkley, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References: