louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04256512: Cryotherapy for the Prevention of Taxane-Induced Sensory Neuropathy of the Hands and Feet in Breast Cancer Patients
Official title: Cryotherapy to Prevent Taxane-Induced Sensory Neuropathy of the Hands and Feet
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Carcinoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This clinical trial investigates the effect and tolerability of cryotherapy and to evaluate whether they can prevent or improve taxane-induced sensory peripheral neuropathy in breast cancer patients. Cryosurgery, also known as cryoablation or cryotherapy, kills tumor cells by freezing them. Patients receiving cryotherapy during infusion of taxane therapy may have lower incidence of peripheral neuropathy, better physical function, and higher quality of life as compared to patients previously reported in literature.

Detailed description: PRIMARY OBJECTIVE:

I. To investigate the efficacy and tolerability of cryotherapy (Elasto Gel frozen mittens and foot wraps) and to evaluate whether they can prevent or ameliorate taxane-induced sensory peripheral neuropathy.

OUTLINE:

Patients wear Elasto Gel Therapy Mittens and Foot Wraps on both hands and feet 15 minutes prior to each infusion, during the entire infusion, and for 15 minutes after the completion of each infusion during their three months of treatment.

Eligibility criteria: Inclusion Criteria:

* Patients \>= 18 years of age with a diagnosis of breast cancer
* Patients receiving 12-18 weeks of chemotherapy with a taxane-based regimen (4 cycles of weekly x 3 paclitaxel or 4-6 cycles of docetaxel every 3 weeks)
* Absence of sensory peripheral neuropathy, skin or nail disorders at the start of treatment
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
* Ability to complete questionnaires by themselves or with assistance
* Ability to give signed informed consent

Exclusion Criteria:

* History of prior sensory/motor peripheral neuropathy from any cause
* History of prior Raynaud's phenomenon
* History of cryoglobulinemia
* Active peripheral vascular disease
* Cold intolerance
* Prior exposure to neurotoxic chemotherapy in the last 10 years
* Hand-foot syndrome
* Tumor metastasis in bone, soft tissue, or skin of the hands or feet
* Absence of one or more fingers or toes
* Prior exposure to taxane chemotherapy

Primary outcomes:
measure: Peripheral neuropathy (PN)
timeFrame: Up to 3 months post chemotherapy
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Pooja Advani
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00794612: Dermacyd Femina Pocket BR (Lactic Acid)- Acceptability.
Official title: Safety Dermatological Evaluation: Genital Mucous Irritation - Test in Use - Dermacyd Femina Pocket BR (Lactic Acid).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hygiene
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-11-20
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to prove the safety of the gynaecological formulation in normal conditions of use.


Eligibility criteria: Inclusion criteria:

* Integral skin test in the region;
* To use products of the same category;

Exclusion criteria:

* Lactation or gestation;
* Use of anti-inflammatory, anti-histaminic or immunosuppressant drugs;
* Cutaneous disease (local or spread) in the evaluation area;
* Pathology which may cause immunity depression, such as HIV, diabetes;
* Endocrine pathology
* Solar exposure 15 days before evaluation;
* Treatment until four months before the selection.
* Allergic or atopic history to cosmetics products

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Absence of irritation
timeFrame: From the start to the end of the study
measure: Good acceptability
timeFrame: From the start to the end of the study
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Jaderson Lima
role: STUDY_DIRECTOR
References:
Clinical trial NCT01210612: The Effect of Five-Toed Socks on Postural Control Among Active Individuals Who Have Chronic Ankle Instabilities
Official title: The Effect of Five-Toed Socks on Postural Control Among Active Individuals Who Have Chronic Ankle Instabilities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ankle Sprain
Lead sponsor: University of Toledo
Sponsor class: OTHER
First posted: 2010-09-28
Enrollment: 53
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: Lateral ankle sprain (LAS) is one of the most common injuries in sports. There is a unique style of socks that have become popular in Japan among athletes that could also improve postural control. The purpose of the study is to determine the effectiveness of five-toed socks on dynamic postural control in individuals with and without chronic ankle instability.

Detailed description: Lateral ankle sprain (LAS) is one of the most common injuries in sports. Ankle braces and orthotic insoles also have been shown to influence the neuromuscular control system by enhancing the proprioceptive and cutaneous afferent inputs to the central nerve system; thereby improving postural control. There is a unique style of socks that have become popular in Japan among athletes that could also improve postural control by enhancing cutaneous afferent inputs from the plantar surface of the foot and toes. The purpose of the study is to determine the effectiveness of five-toed socks on dynamic postural control in individuals with and without chronic ankle instability.

Eligibility criteria: Inclusion Criteria:

* member of university community
* All subjects will be physically active (at least 30 minutes of sustained exercise 3 times/week

Exclusion Criteria:

* history of: knee or hip musculoskeletal injury or surgery
* history of: fracture or dislocation of the testing ankle or leg
* neurological problems
* vestibular disorders or concussions within the last 6 months

Primary outcomes:
measure: The Primary Outcome Measurement for This Study Was to Determine Differences in Center of Pressure (COP) and Static Postural Control Patterns in Individuals With and Without CAI During the Single Limb Balance Test.
timeFrame: 3 weeks
Secondary outcomes:
measure: Reaching Distances
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Toledo
country: United States
facility: University of Toledo
state: Ohio
Study officials:
affiliation: University of Toledo
name: Phillip Gribble
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03540446: First Relief Treatment for Peripheral Neuropathy
Official title: To Prove the Effectiveness of PENS Therapy With Peripheral Neuropathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peripheral Neuropathy
Keywords: First Relief
Diebetes
Pheripheral Neuropathy
Pain Releif
Lead sponsor: DyAnsys, Inc.
Sponsor class: INDUSTRY
First posted: 2018-05-30
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: To prove the effectiveness of Percutaneous Electrical Neuro-stimulation therapy for the treatment of conditions associated with peripheral neuropathy, in a double-blind environment.


Eligibility criteria: Inclusion Criteria:

* Patients with Neuropathy pain

Exclusion Criteria:

* Patient with inbuilt pacemakers or any other devices which allows current into the body, pregnant ladies.

Primary outcomes:
measure: Reduction of Neuropathy pain
timeFrame: According to the patients condition and other factors expected to reduce pain in 4th week of the treatment
Secondary outcomes:
measure: Check for delay of Re-occurrence of pain within a short time
timeFrame: 90 Days
Other outcomes:
measure: Complete reduction of conditions associated with peripheral neuropathy
timeFrame: 7 weeks
Locations:
city: Warangal
country: India
facility: Clinic
state: Telangana
Study officials:
affiliation: Jeevak hospital
name: Dr. Gurunath, Ph.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT04397146: Palatability and Perceived Satiety of Oral Nutrition Supplements
Official title: Palatability and Satiating Effects of Oral Nutrition Supplements as Perceived by Independently Living Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sensory Evaluation
Perceived Satiety
Lead sponsor: Wageningen University and Research
Sponsor class: OTHER
Collaborators: name: Fonterra (Europe) Cooperatie U.A.
First posted: 2020-05-21
Enrollment: 104
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Each study participant evaluates 8 different ONS products on palatability and perceived satiety
Primary purpose: OTHER

Brief summary: The objective of the study is to evaluate palatability (primary objective) and perceived satiating effects (secondary objective) of two Oral Nutrition Supplements (ONS) prototypes and six commercially available ONS products. The products are matched on calorie content per portion.

The study is a single-blind intervention with a within-subjects design. In total 104 apparently healthy and independently living older adults aged 65 will be recruited to participate. Participants will visit the research facilities eight times in a period of one month. On each test-day participants will consume and evaluate a single product.


Eligibility criteria: Inclusion Criteria:

* Age 65 years or over
* Apparently healthy
* Living independently

Exclusion Criteria:

* Allergies to soy, dairy or gluten
* Following a specific diet
* BMI\>30 kg/m2
* Reduced kidney function
* Suffering from Alzheimer's disease, Dementia, Parkinson's Disease, Cancer, Kidney Disease or Diabetes
* Suffering from Dysphagia
* Already using oral nutritional supplements
* Receiving any medical treatment that is known to reduce the taste or sense of smell
* Current smokers
* Participation in another clinical trial at the same time

Primary outcomes:
measure: Liking
timeFrame: Immediately after consumption of one sip of the ONS product
measure: Liking
timeFrame: Immediately after finishing consumption of a full portion of the ONS product
Secondary outcomes:
measure: Satiety
timeFrame: Before consumption of the ONS product
measure: Satiety
timeFrame: Immediately after finishing consumption of a full portion of the ONS product
measure: Satiety
timeFrame: 1 hour after finishing consumption of a full portion of the ONS product
measure: Satiety
timeFrame: 2 hours after finishing consumption of a full portion of the ONS product
Other outcomes:
Locations:
city: Wageningen
country: Netherlands
facility: Stichting Wageningen Research
state: Gelderland
Study officials:
References:
Clinical trial NCT03147846: The Hematologic Impact of Umbilical Cord Milking Versus Deferred Cord Clamping in Premature Neonates.
Official title: The Hematologic Impact of Umbilical Cord Milking Versus Deferred Cord Clamping in Premature Neonates. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Delayed Cord Clamping
Umbilical Cord Milking
Preterm Neonates
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
Collaborators: name: Armed Forces Hospitals, Southern Region, Saudi Arabia
First posted: 2017-05-10
Enrollment: 200
Sex: ALL
Minimum age (years): 24
Maximum age (years): 35
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Comparing the beneficial effect of cord milking versus deferred cord clamping in preterm neonates. A randomized controlled trial

Detailed description: Placental transfusion either by deferred cord clamping or umbilical cord milking became standard care and recommended management especially in preterm deliveries.1 In average, about 80 ml of blood was found to be transferred to the neoborn by one minute after birth.2 This additional blood can afford extra iron and blood volume giving the benefit of less iron deficiency anemia during the first year of life, less need for blood transfusion, less need for vasopressors and less intraventricular hemorrhage (IVH) by 50%.3 Placental transfusion with different techniques proved safety with no significant risks regarding postpartum hemorrhage, polycythemia, jaundice, Apgar score or admission rates.4 Our study aims to compare delayed cord clamping with umbilical cord milking as the best way for placental transfusion for preterm neonates.

Eligibility criteria: Inclusion Criteria:

• Gestational age 24 to 34+6 weeks

Exclusion Criteria:

* Category III CTG
* Monochorionic twins
* Significant antepartum hemorrhage
* IUGR or Rh incompatibility

Primary outcomes:
measure: hematological parameters of the premature neonates
timeFrame: 12 months
Secondary outcomes:
measure: composite neonatal morbidities
timeFrame: 12 month
Other outcomes:
Locations:
city: Khamis Mushait
country: Saudi Arabia
facility: Armed Forces Hospital of Southern Region
Study officials:
affiliation: Armed forces hospitals Southern Region KSA
name: Hytham Atia, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Atia H, Badawie A, Elsaid O, Kashef M, Alhaddad N, Gomaa M. The hematological impact of umbilical cord milking versus delayed cord clamping in premature neonates: a randomized controlled trial. BMC Pregnancy Childbirth. 2022 Sep 19;22(1):714. doi: 10.1186/s12884-022-05046-7.
Clinical trial NCT01027546: Effect of Tranexamic Acid on Reducing Postoperative Blood Loss in Cervical Laminoplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Myelopathy
Keywords: perioperative blood loss, spinal surgery
Lead sponsor: Yodakubo Hospital
Sponsor class: OTHER
First posted: 2009-12-08
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose is to evaluate the efficacy of tranexamic acid in cervical laminoplasty; the surgical procedure used was identical in all cases.

Detailed description: Tranexamic acid, an inhibitor of fibrinolysis, has proven to be effective in reducing perioperative blood loss in patients undergoing total hip and knee arthroplasty. However, limited numbers of well-controlled trials in spinal surgery have been conducted due to heterogeneity in the performed surgical procedures.

Eligibility criteria: Inclusion Criteria:

* Patients who were scheduled to undergo cervical laminoplasty from C3 to C6 for cervical multilevel compressive myelopathy with a narrow spinal canal for which nonoperative therapy had failed.

Exclusion Criteria:

* Patients with chronic renal failure, cirrhosis of the liver, serious cardiac disease, allergy to TXA, a history of thromboembolic disease, and bleeding disorders, as well as those who were currently receiving antiplatelet and/or anticoagulant drugs, were excluded from this study.

Primary outcomes:
measure: perioperative blood loss
timeFrame: during and after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00010946: Acupuncture Safety/Efficacy in Knee Osteoarthritis
Official title: Acupuncture Safety/Efficacy in Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis, Knee
Keywords: acupuncture
osteoarthritis
elderly
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2001-02-05
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: The goal of this research is to determine the efficacy and safety of Traditional Chinese Acupuncture (TCA) in patients with osteoarthritis of the knee. A three arm randomized controlled trial (RCT) using sham TCA, true TCA, and an education/attention comparison group with a total sample of 525 is proposed. Primary hypothesis to be tested is that patients randomized to true TCA will have significantly more improvement in pain and function as measured by the Womac Pain \& Function Scales and patient global assessments than patients randomized to the sham acupuncture and education/attention control groups.

Secondary aims of the study are to 1) determine if improvement with TCA differs between patients below age 65 vs. those aged 65 and above, 2) to determine if improvement with TCA differs by racial/ethnic group (ie., Caucasian, Black, Hispanic), and 3) to determine if improvement with TCA differs by stage of radiographic severity of knee OA at baseline (KL grade 2, 3 or 4)


Eligibility criteria: Inclusion Criteria:

* Diagnosis of osteoarthritis of the knee (fulfilling ACR criteria) for at least 6 months duration
* At least moderate pain in the knee for most days in the last month
* Must be taking analgesic or nonsteroidal anti-inflammatory agents for control of pain
* Documented radiographic changes of osteoarthritis (Kellgren-Lawrence grade\>2) at the time of rheumatological screening
* Signed informed consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Kernan Hospital Mansion
state: Maryland
city: Catonsville
country: United States
facility: Catonsville Clinic
state: Maryland
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: University of Maryland/Complementary Medicine Program
name: Dr. Brian Berman
role: PRINCIPAL_INVESTIGATOR
References:
citation: Berman BM, Singh BB, Lao L, Langenberg P, Li H, Hadhazy V, Bareta J, Hochberg M. A randomized trial of acupuncture as an adjunctive therapy in osteoarthritis of the knee. Rheumatology (Oxford). 1999 Apr;38(4):346-54. doi: 10.1093/rheumatology/38.4.346.
citation: Berman BM, Lao L, Greene M, Anderson RW, Wong RH, Langenberg P, Hochberg MC. Efficacy of traditional Chinese acupuncture in the treatment of symptomatic knee osteoarthritis: a pilot study. Osteoarthritis Cartilage. 1995 Jun;3(2):139-42. doi: 10.1016/s1063-4584(05)80046-9. No abstract available.
Clinical trial NCT00874146: Level of HER2-neu Gene Amplification an Response to Trastuzumab
Official title: Retrospective Study of the Level of HER2-neu Gene Amplification as Predictive Factor of Response in Patients With HER2-positive Advanced Breast Cancer Treated With Trastuzumab Containing Regimens.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Advanced Breast Cancer
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2009-04-02
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with HER2-positive advanced breast cancer treated with trastuzumab-containing regimen.

Brief summary: Primary objective of the study is to evaluate the correlation between level of HER2-neu gene amplification evalued by dual-color Fluorescent in-situ hybridization (FISH) test and time to progression (TTP) in patients with HER2-positive advanced breast cancer treated with trastuzumab-containing regimens.


Eligibility criteria: Inclusion Criteria:

* HER2-positive breast cancer Trastuzumab-containing regimen delivered for advanced disease Tumor sample available at Pathology Archive

Exclusion Criteria:

* HER2-negative advanced breast cancer Pretreatment with trastuzumab

Primary outcomes:
measure: Association of tumor cytogenetic paremeters with TTP and OS.
timeFrame: one year
Secondary outcomes:
measure: Association of cytogenetic parameters evalued by FISH test and patients' characteristics.
timeFrame: one year
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Istituto Clinco Humanitas
state: Milan
Study officials:
affiliation: Istituto Clinico Humanitas
name: Armando Santoro, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02196246: Moletest Clinical Study in Scotland
Official title: A Clinical Study to Evaluate the Ability of an iPad Based Photographic Image Analysis System to Discriminate Benign Skin Lesions From Those Considered Suspect for Melanoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Melanoma
Lead sponsor: Moletest Scotland Ltd
Sponsor class: INDUSTRY
Collaborators: name: Digital Health & Care Institute
name: NHS Lanarkshire
First posted: 2014-07-22
Enrollment: 1120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients referred to the Dermatology Department, Lanarkshire Hospitals for assessment of suspicious skin lesions are eligible for inclusion

Brief summary: To evaluate an iPad based photoimage analysis system (Moletest) for improving discrimination of benign from malignant suspicious skin lesions or moles. Specifically the objective is to demonstrate that the Moletest system is able with a sufficient degree of confidence (95%) to identify lesions which are benign


Eligibility criteria: Inclusion Criteria:

All patients referred to the Dermatology Department, Lanarkshire Hospitals during a period to be defined for assessment of suspicious skin lesions (cutaneous moles) will be eligible for inclusion in the study. There are no age limits but patients under the age of 18 years will also have their inclusion subject to parental/guardian consent

Exclusion Criteria:

There is no exclsion criteria

Primary outcomes:
measure: Clinical accuracy of Moletest application, the combined measured attributes of a suspect legion compared to the outcome of a biopsy performed on the legion
timeFrame: 6 weeks turnaround for each sample
Secondary outcomes:
Other outcomes:
Locations:
city: Airdrie
country: United Kingdom
facility: NHS Lanarkshire R&D
Study officials:
affiliation: Royal College of Physicians
name: Peter Freedman
role: STUDY_DIRECTOR
References: