louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06199115: Prevention of Neuropathic Pain From Oxaliplatin by Photobiomodulation
Official title: Prevention of Neuropathic Pain From Oxaliplatin by Photobiomodulation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer of the Gastrointestinal Tract
Keywords: Photobiomodulation
Pain
oxaliplatin
peripheral neuropathy
chemotherapy
SUDOSCAN
Lead sponsor: Saint-Gregoire Private Hospital Center
Sponsor class: OTHER
First posted: 2024-01-10
Enrollment: 70
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: Peripheral neuropathy is one of the most common side effects of oxaliplatin (OXA)-based chemotherapy for patients treated for digestive cancers, disabling and dose-limiting. Several strategies have been studied for the treatment of oxaliplatin-related sensory neuropathy. Several pharmacological and non-pharmacological therapeutic strategies have been explored to relieve peripheral neuropathic pain. Non-pharmacological interventions have been shown to be potentially beneficial for patients suffering from chemotherapy-induced neurotoxicity. The objective of this prospective study is to evaluate the effectiveness of photobiomodulation on the reduction of neuropathic pain in patients who developed painful, cumulative peripheral neuropathy that appeared under the effect of the treatment.


Eligibility criteria: Inclusion Criteria:

* Recent diagnosis of digestive cancer
* 12 planned cycles of oxaliplatin
* Ability to understand and willingness to sign an informed consent form before starting any study procedures
* Patient benefiting from French health insurance

Exclusion Criteria:

* History of neuropathy before the start of the study,
* Symptomatic treatment of pain (or neuropathic pain),
* Patient with a psychotic disorder,
* Patient with diabetic neuropathy,
* Patient with metastatic cancer
* Patient with renal insufficiency,
* Adults under guardianship or curatorship,
* Vulnerable people

Primary outcomes:
measure: Neuropathic Pain Synptom Inventory : pain
timeFrame: day 30, day 60, day 90, day 120, day 150, day 180, day 270
Secondary outcomes:
measure: Health-relative quality of life of cancer patients participating to a clinical trial
timeFrame: day 0, day 60, day 120, day 180, day 270
measure: Peripheral neuropathy : SUDOSCAN evaluation
timeFrame: day 0, day 30, day 60, day 90, day 120, day 150, day 180, day 270
measure: Peripheral neuropathy : electroneuromyogram evaluation
timeFrame: day 0, day 90, day 270
measure: Evaluation of sensitive and motor symptoms
timeFrame: day 30, day 60, day 90, day 120, day 150, day 180, day 270
Other outcomes:
Locations:
city: Saint-Grégoire
country: France
facility: CHP Saint-Grégoire
Study officials:
affiliation: CHP Saint-Grégoire
name: Morgane Pihan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02929615: Study of Standard and Individualized Treatment Model for Relapse and Refractory Lymphatic System Malignant Tumors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Lymphoma
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2016-10-11
Enrollment: 50
Sex: ALL
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to research the standard and individualized treatment model for relapse and refractory lymphatic system malignant tumors.


Eligibility criteria: Inclusion Criteria:

1. Patients with relapse and refractory lymphoma and multiple myeloma.
2. At least 1 measurable lesions and its size≥15mm.
3. Patients ≤65 years，no limitations for both gender.
4. ECOG score is 0-1.
5. Life expectancy≥3 months.
6. LVEF≥ 55%; Peripheral blood: WBC ≥ 3.5×10(9)/L,neutrophil ≥1.5×10(9)/L, PLT≥75×109/L，Hb≥90g/L; Renal function: Cr≤2.0×UNL; Liver function: BIL≤2.0×UNL，ALT/AST≤2.5×UNL;
7. Written informed consent are acquired.

Exclusion Criteria:

1. Previously received stem cell transplantation.
2. Women with pregnant, lactating or not to take contraceptive measures.
3. Severe acute infection or suppurative and chronic infection that wound not healing.
4. Severe heart failure.
5. Suffering from mental disorders and poor compliance.
6. Other situations that investigators consider as contra-indication for this study.

Primary outcomes:
measure: overall response rate
timeFrame: 2 years after treatment
measure: complete response
timeFrame: 2 years after treatment
measure: progression-free survival
timeFrame: 2 years after treatment
measure: overall survival
timeFrame: 2 years after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
state: Beijing
Study officials:
References:
Clinical trial NCT04641715: OAGB-MGB Conversions for Post-operative Complications
Official title: OAGB-MGB Conversion for Failed Procedure: a Multicenter Italian Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bariatric Surgery Candidate
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2020-11-24
Enrollment: 207
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients elegible for conversion from OAGB-MGB to other bariatric procedures

Brief summary: Laparoscopic mini/one anastomosis gastric bypass (MGB/OAGB) is a relatively new bariatric procedure and is gaining ground over the surgical approach for morbid obesity as a safe and effective operation. Revision of MGB/OAGB was never studied before as multicenter data collection: we collected data from 21 italian centers who perform MGB/OAGB to evaluate patients' conditions which determinated the conversion from this procedure to another kind of bariatric technique.

Detailed description: MGB / OAGB has been shown to be an effective and safe bariatric technique. Despite that, the complications of this procedure have already been extensively described in the literature. Our goal is to collect data from 21 Italian centers that practice MGB / OAGB to evaluate the reasons and complications that led surgeons to revise this surgery with a subsequent bariatric procedure. For this reason we have analyzed the data provided by the centers on 8676 patients undergoing MGB / OAGB, focusing attention on phenomena such as GERD, anastomotic stenosis, bleeding and marginal ulcers which are the most frequent causes of re-intervention. We also evaluated the changes in BMI between the primary procedure and the revision procedure to ensure that the bariatric purpose of the surgical program was maintained.

Eligibility criteria: Inclusion Criteria:

* Patients underwent to OAGB-MGB who needed conversion to other bariatric procedure

Exclusion Criteria:

* Patients underwent to OAGB-MGB who needed conversion to other bariatric procedure in emergency within 48/72 hours after the first surgery

Primary outcomes:
measure: Reasons for Conversion from MGB/OAGB to other bariatric procedures
timeFrame: From 2006 to 2020
measure: Surgical type of conversion from MGB/OAGB
timeFrame: From 2006 to 2020
Secondary outcomes:
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Nunzio Velotti
Study officials:
affiliation: Federico II University
name: Mario Musella, Full Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00520715: Epidemiology of Fluoroquinolone Resistance in Human Commensal Flora in Patients Hospitalised in Medical Wards
Official title: Epidemiology and Risk Factors Study of the Carriage of Fluoroquinolone Resistant Bacteria in the Commensal Flora of Patients Hospitalised in Medical Wards
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colonization
Multi Drug Resistant Bacteria
Hospitalized Patients
Keywords: fluoroquinolone resistance
commensal flora
carriage
Lead sponsor: Association Pour le Recherche en Infectiologie et en Médecine Interne
Sponsor class: OTHER
Collaborators: name: Pr Bruno Fantin
First posted: 2007-08-24
Enrollment: 640
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: adults patients at hospital admission hospital stay \>24 hours informed consent required

Brief summary: Emergence of bacterial resistance to antibiotics, which is a major public health issue, appears to involve predominantly commensal flora. No data exists concerning risk factors for the carriage of fluoroquinolone resistant bacteria in the flora of hospitalised patients. We will conduct a prospective open study including all unselected patients hospitalised in medical wards of one hospital. Nasal, pharyngeal and rectal swabs will be performed upon admission as well as a review of potential risk factors, after patient's information and acceptance. Resistance testing aiming 3 pathogens (Staphylococcus, Streptococcus and E. coli) will be performed on all specimens, and a case control study will compare risk factors from the resistant and non-resistant groups, for each pathogen. A thousand patients should be included in a year's time. This work could help understand risk factors involved in the carriage of fluoroquinolone resistant pathogens, potentially responsible for invasive infections and inter-patient transmission of resistance. Limiting bacterial resistance and transmission is a goal that can be successfully undertaken only if resistance mechanisms, but also risk factors of acquiring resistant bacteria are better understood.


Eligibility criteria: Inclusion Criteria:

* all adult patients admitted to the internal medicine, oncology, cardiology and geriatric unit of Beaujon Hospital, Clichy, France.
* patient agreement

Exclusion Criteria:

* Age \< 18
* patient refusal or incapable

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Clichy
country: France
facility: Hôpital Beaujon
state: Ile de France
Study officials:
name: Victoire de Lastours, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: de Lastours V, Chau F, Tubach F, Pasquet B, Ruppe E, Fantin B. Independent behavior of commensal flora for carriage of fluoroquinolone-resistant bacteria in patients at admission. Antimicrob Agents Chemother. 2010 Dec;54(12):5193-200. doi: 10.1128/AAC.00823-10. Epub 2010 Sep 27.
Clinical trial NCT05434715: Evaluation of Minimal Invasive Thyroidectomy
Official title: Evaluation of Minimal Invasive Thyroidectomy; A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thyroid
Goiter
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2022-06-28
Enrollment: 120
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: The goals of minimally invasive approaches are better cosmetic results with small neck scar, decreasing postoperative pain, and shortening of hospital stay periods without postoperative complications.

The concept of surgical invasiveness cannot be limited to the length and site of the skin incision; it must be extended to all structures dissected during the procedure. Conventional thyroidectomy without raising subplatysmal flaps has proven to be effective in reducing postoperative pain and seroma

Detailed description: Minimal invasive flapless thyroidectomy (MIFT) is a new technique that can be used in replacement of the conventional method of thyroidectomy for the management of selected cases of benign thyroid disorders.

This work aims to evaluate the feasibility, safety, and efficacy of Minimal Invasive Flapless Thyroidectomy (MIFT) in the management of thyroid disease as regards postoperative pain, cosmesis, operative time, and other postoperative complications in comparison to Conventional thyroidectomy technique.

Eligibility criteria: Inclusion Criteria:

* The limited size of the gland: volume less than 50 mm by ultrasound assessment. No evidence of retro-sternal extension. Benign nature of the disease proved by FNAC.

Exclusion Criteria:

* the patients who have one or more of the following criteria:

  1. The size of the gland is more than 50 mm by ultrasound assessment.
  2. Patients with retro-sternal goitre.
  3. Patients with proved malignancy or suspicious for malignancy by Ultrasonography(US) or by Fine-Needle Aspiration Cytology (FNAC).
  4. Previous surgery or radiotherapy to the neck.
  5. Thyroiditis.

Primary outcomes:
measure: Degree of satisification of cosmetic appearance of the thyroidectomy scar
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kafr Ash Shaykh
country: Egypt
facility: Kafrelsheikh University
state: Kafr Al Sheikh
Study officials:
References:
Clinical trial NCT03216915: Effects of Fingolimod on Heart Rhythm and Heart Rate Variability in Patients With Multiple Sclerosis
Official title: FINGORHYMS - Effects of Fingolimod on Heart Rhythm and Heart Rate Variability in Patients With Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Sclerosis
Keywords: Heart Rhythm
Fingolimod
autonomic nervous system
Effects of Medicinal Substance
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2017-07-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with relapsing-remitting forms of multiple sclerosis who were considered eligible for fingolimod treatment on a clinical basis.

Brief summary: The current study sought to prolong the observational interval after initiating medication with fingolimod and to measure the long-term effects of fingolimod on HR and HRV as an indicator of autonomic nervous system function in patients with RR-MS.

Detailed description: Fingolimod (Gilenya®; Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA) is a novel oral disease-modifying therapy that acts as a sphingosine-1-phosphate (S1P) receptor agonist and reduces the recirculation of lymphocytes to blood and peripheral tissues, including inflammatory lesions.

A critical part of fingolimod therapy still remains in the screening and initiation phases because of the risk of cardiac events. It is well known that the first dose of fingolimod is associated with a decrease in heart rate (HR) and slowing of atrioventricular (AV) conduction. Patients were continuously observed for a minimum of 6 hours after taking fingolimod. Because resurgence of heart rate began at 6 hours, the actual recommendation for observation is only 6 hours. Data about the effect of fingolimod after this time period is lacking.

Eligibility criteria: Inclusion Criteria:

* Ability to provide written informed consent in accordance with Good Epidemiological Practice and local legislation
* Individuals over the age of 18 years
* Patients with relapsing-remitting forms of multiple sclerosis who were considered eligible for fingolimod treatment on a clinical basis.

Exclusion Criteria:

* Insufficient knowledge of the German language (not able to understand and write the German language)
* Physical or psychological incapability to take part in the study

Primary outcomes:
measure: Recurrence of AF
timeFrame: 6 months follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Medical Hospital Hamburg-Eppendorf
Study officials:
affiliation: University Medical Hospital Hamburg-Eppendorf
name: Christoph Heesen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01321515: Bioequivalency Study of Famciclovir 500 mg Tablets Under Fasted Conditions
Official title: A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Famciclovir Tablets Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Herpes
Lead sponsor: West-Ward Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2011-03-23
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study was to prove the bioequivalence of Famciclovir 500 mg Tablets under fasting conditions.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to famciclovir, penciclovir or any comparable or similar product.

Primary outcomes:
measure: bioequivalence determined by statistical comparison Cmax
timeFrame: 8 days
Secondary outcomes:
Other outcomes:
Locations:
city: Hackensack
country: United States
facility: Advanced Biomedical Research, Inc.
state: New Jersey
Study officials:
affiliation: Advanced Biomedical Research
name: Benno G Roesch, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02174315: Motivational Incentives for Alcohol Abstinence in American Indian and Native Alaskan Adults
Official title: Contingency Management Treatment of Alcohol Abuse American Indian People
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Abuse
Lead sponsor: Washington State University
Sponsor class: OTHER
First posted: 2014-06-25
Enrollment: 400
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 examines the impact of a culturally tailored version of contingency management treatment on alcohol in 400 alcohol dependent American Indians and Alaskan Natives. Participants will be recruited from addiction treatment agencies and throughout the community. Those who complete a 4 week induction period will be randomized to receive 12 weeks of contingency management or a non-contingent control condition. Individuals will then be followed for an additional 3-months to assess the long term efficacy of the treatment.


Eligibility criteria: Inclusion Criteria:

* Self reported American Indian/Alaskan Native
* Current alcohol dependence
* 5 or more standard drink on 1 or more occasions in the last 30 days
* Ability to read and speak English
* Ability to provide written informed consent

Exclusion Criteria:

* Illicit drug use greater than alcohol use in the last 90 days
* A risk of dangerous alcohol withdrawal
* Any medical or psychiatric condition, such as organic brain disorder, dementia, or psychotic disorder

Primary outcomes:
measure: Change in alcohol use as assessed by ethyl glucuronide detection in urine
timeFrame: Twice weekly for twelve weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Pullman
country: United States
facility: Contact PI
state: Washington
Study officials:
affiliation: Washington State University
name: Michael McDonell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hirchak KA, Lyons AJ, Herron JL, Kordas G, Shaw JL, Jansen K, Avey JP, McPherson SM, Donovan D, Roll J, Buchwald D, Ries R, McDonell MG; HONOR Study Team. Contingency management for alcohol use disorder reduces cannabis use among American Indian and Alaska Native adults. J Subst Abuse Treat. 2022 Jun;137:108693. doi: 10.1016/j.jsat.2021.108693. Epub 2021 Dec 11.
citation: McDonell MG, Hirchak KA, Herron J, Lyons AJ, Alcover KC, Shaw J, Kordas G, Dirks LG, Jansen K, Avey J, Lillie K, Donovan D, McPherson SM, Dillard D, Ries R, Roll J, Buchwald D; HONOR Study Team. Effect of Incentives for Alcohol Abstinence in Partnership With 3 American Indian and Alaska Native Communities: A Randomized Clinical Trial. JAMA Psychiatry. 2021 Jun 1;78(6):599-606. doi: 10.1001/jamapsychiatry.2020.4768.
Clinical trial NCT03808415: CUHK Jockey Club HOPE 4 Care Programme - Hand of Hope
Official title: Jockey Club Tech-based Stroke Rehabilitation Programme - Hand of Hope
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: The Hong Kong Jockey Club Charities Trust
First posted: 2019-01-17
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The Hong Kong Jockey Club Charities Trust has supported CUHK to launch a three-year project 'CUHK Jockey Club HOPE4Care Programme' to implement four evidence-based advanced rehabilitation technologies in 40 local elderly day care centres and rehabilitation centres, to benefit the community.

The interactive intention-driven hand training robotic system is used for neuromuscular rehabilitation of the hand and forearm. This can help stroke survivors to regain their hand functions through motor relearning.


Eligibility criteria: Inclusion Criteria:

* at least six months after the onset of a unilateral ischemic brain injury or intracerebral haemorrhage
* upper-limb motor impairments due to stroke
* metacarpophalangeal and proximal interphalangeal joints of fingers can be extended to 180 degree passively
* spasticity during extension at the finger joints is lower than 3 as measured by the Modified Ashworth Scale
* detectable voluntary EMG signals from the flexor digitorum and extensor digitorum muscles of the paretic hand
* have sufficient cognition to follow the experimental instructions

Exclusion Criteria:

* have other neurological, neuromuscular, and orthopedic diseases
* have shoulder or arm contracture/pain

Primary outcomes:
measure: Action Research Arm Test (ARAT)
timeFrame: 3-month follow-up
measure: Fugl-Meyer Assessment Upper Extremity (FMA-UE)
timeFrame: 3-month follow-up
measure: Wolf Motor Function Test (WMFT)
timeFrame: 3-month follow-up
Secondary outcomes:
measure: Modified Ashworth Scale (MAS)
timeFrame: 3-month follow-up
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Department of Biomedical Engineering, The Chinese University of Hong Kong
Study officials:
affiliation: Department of Biomedical Engineering, CUHK
name: Raymond Tong, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01372215: Multi-Compression Spot Mammography
Official title: Multi-Compression Spot Mammography
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Breast Diseases
Keywords: Breast mass
Breast lesion
Lead sponsor: State University of New York - Upstate Medical University
Sponsor class: OTHER
First posted: 2011-06-13
Enrollment: 3
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women 45 years of age and older who have a suspicious mammagraphy requiring a biopsy

Brief summary: In this study, participants, who are scheduled to have a breast biopsy, will have several extra spot mammogram images taken of the suspicious area. These images will be acquired with varying levels of compression. The images will then be analyzed to determine whether the type of lesion (malignant or benign) can be determined from the image data alone. The biopsy results will be used as a gold standard to determine the true malignancy status


Eligibility criteria: Inclusion Criteria:

* Women 45 years and older
* Women with suspicious mammography findings requiring a biopsy

Exclusion Criteria:

* Men
* Pregnant women

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Syracuse
country: United States
facility: University Health Care Center (UHCC)
state: New York
Study officials:
affiliation: State University of New York - Upstate Medical University
name: Kent Ogden, PhD
role: PRINCIPAL_INVESTIGATOR
References: