louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06350435: Effects of Prefabricated Foot Orthoses With and Without Metatarsal Pads on Central Metatarsalgia
Official title: Effects of Prefabricated Foot Orthoses With and Without Metatarsal Pads in People With Central Metatarsalgia: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metatarsalgia
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Pamela Youde Nethersole Eastern Hospital
First posted: 2024-04-05
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Compare the effects of prefabricated foot orthoses with and without metatarsal pads on pain intensity in the 2nd to 4th metatarsophalangeal joints, foot and ankle functional abilities as well as the occurrence of plantar callosities among patients with central metatarsalgia.

Detailed description: Metatarsalgia is a common condition that affecting about 10% of the general population. Central metatarsalgia involves pathology of the 2nd to 4th metatarsal and their respective metatarsophalangeal joints. This randomized control trial is designed to compare the effects of prefabricated foot orthoses with and without metatarsal pads on pain intensity, foot and ankle functional abilities as well as the occurrence of plantar callosities.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years;
* Complain of foot pain on the 2nd to 4th MTPJs during walking in shoes, rating the pain intensity as ≥ 50mm on the Visual Analogue Scale (VAS);
* Able to be ambulant

Exclusion Criteria:

* Peripheral vascular disease (PVD)
* Neurological dysfunctions or neuromuscular disorders
* Active infection, i.e., cellulitis, osteomyelitis, shingles
* Cognitive impairment
* History of lower limb surgery and currently undergoing rehabilitation
* Active ulceration on foot and ankle
* Current utilization of prescribed insoles

Primary outcomes:
measure: Pain intensity at the 2nd to 4th metatarsophalangeal joints during walking in shoes on Visual Analogue Scale
timeFrame: Baseline, a follow-up at 4-8 weeks from baseline
Secondary outcomes:
measure: Foot and Ankle Outcome Score (FAOS)
timeFrame: Baseline, a follow-up at 4-8 weeks from baseline
measure: Size of callosities and corns on the plantar area of the 2nd to 4th metatarsophalangeal joints
timeFrame: Baseline, a follow-up at 4-8 weeks from baseline
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Pamela Youde Nethersole Eastern Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: Fung Ting Chan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00315835: Safety of the Buprenorphine Transdermal Delivery System in Subjects With Mod-to-Sev Pain Following Orthopedic Surgery.
Official title: A Single Dose, Randomized, Double-Blind, Parallel Group Study of the Safety and Pharmacokinetics of Buprenorphine TDS (12.5, 25, 50 Mcg/Hour) Vs. Placebo in Patients With Moderate to Severe Pain Following Orthopedic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postoperative Pain
Keywords: postoperative pain
opioid
transdermal
Lead sponsor: Purdue Pharma LP
Sponsor class: INDUSTRY
First posted: 2006-04-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to assess the safety of the buprenorphine transdermal system (5, 10, and 20 mg) in comparison to placebo transdermal system in subjects with moderate to severe pain after orthopedic surgery. The double-blind treatment intervention duration is 72 hours during which time supplemental analgesic medication (intravenous morphine PCA) will be provided to all subjects in addition to study drug.

Detailed description: Buprenorphine is a synthetic opioid analgesic with over twenty-five years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain. Transdermal systems may offer advantages over currently indicated oral products including ease and convenience of use, improved compliance, possible reduction in patient care, and prolonged and consistent delivery of drug.

Eligibility criteria: Inclusion Criteria:

* underwent any major orthopedic surgical procedure requiring general anesthesia, and were expected to be hospitalized \>/=4 days postoperatively.
* in moderate or greater pain post-recovery from anesthesia and were expected to be in, or greater than, moderate pain, without analgesics, for \>/=4 days post-surgery.

Exclusion Criteria:

* receiving chronic opioid therapy preoperatively for \>1 month that was at a total daily dose of \>/= 60 mg of oral morphine equivalents.
* have significant concurrent pulmonary conditions.

Other protocol-specific exclusion/inclusion criteria may apply.

Primary outcomes:
measure: clinical laboratory tests
measure: vital signs
measure: physical examinations
measure: electrocardiograms
measure: elicited opioid side effects
measure: pulmonary function tests (O2 saturation, peak flow, forced expiratory volume, forced vital capacity, respiratory rate, and respiratory depression/hypoxia)
measure: adverse events
measure: application site skin observations
measure: plasma concentrations of buprenorphine at hours 0, 2, 4, 6, 12, 24, 30, 36, 48, 54, 60, 72, 78, or at early termination
Secondary outcomes:
measure: pain intensity
measure: acceptability of therapy
measure: quality of sleep
measure: rescue dose usage
Other outcomes:
Locations:
city: Plantation
country: United States
facility: Park Place Therapeutic Center
state: Florida
Study officials:
References:
Clinical trial NCT05103735: Propofol-remifentanyl Versus Dexmedetomidine in Awake Craniotomy: Impact on Electroclinical Seizure Activity
Official title: Propofol-remifentanil Versus Dexmedetomidine in Awake Craniotomy: an Intraoperative Neurophysiological Evaluation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Craniotomy
Seizures
Dexmedetomidine
Propofol
Remifentanil
Cerebral Tumor
Neurophysiology
Lead sponsor: Azienda Sanitaria-Universitaria Integrata di Udine
Sponsor class: OTHER
First posted: 2021-11-02
Enrollment: 170
Sex: ALL
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: ALL PATIENTS UNDERGOING AWAKE CRANIOTOMY FOR TUMOR RESECTION SURGERY

Brief summary: Awake craniotomy require a cooperative patient during resection neurosurgery phase. Anesthesiologist should guarantee analgesia, sedation, nausea and vomiting prevention, while maintaining normal vital parameters.

Neurosurgeon could be help by Intraoperative electrocorticography to maximise lesion resection and avoiding neurologic sequelae. Propofol and remifentanyl have been largely used. Dexmedetomidine represents an alternative. However little is known about the role of dexmedetomidine on Intraoperative electrocorticography.


Eligibility criteria: Inclusion Criteria:

* PATIENTS UNDERGOING AWAKE CRANIOTOMY FOR TUMOR RESECTION (EXCLUDED E.G. SURGERY OF EPILEPSIA)
* INTRAOPERATIVE MONITORING (IOM) WITH ELECTROCORTICOGRAPHY
* AWAKE-AWAKE-AWAKE TECHNIQUE

Exclusion Criteria:

* AGE \<18 YEARS OLD
* NON AWAKE-AWAKE-AWAKE TECHNIQUE
* ABSENCE OF IOM

Primary outcomes:
measure: SEIZURE ACTIVITY
timeFrame: DURING TUMOR RESECTION PHASE OF THE AWAKE CRANIOTOMY
Secondary outcomes:
Other outcomes:
Locations:
city: Udine
country: Italy
facility: Cristian Deana
Study officials:
References:
citation: Deana C, Pez S, Ius T, Furlan D, Nilo A, Isola M, De Martino M, Mauro S, Verriello L, Lettieri C, Tomasino B, Valente M, Skrap M, Vetrugno L, Pauletto G. Effect of Dexmedetomidine versus Propofol on Intraoperative Seizure Onset During Awake Craniotomy: A Retrospective Study. World Neurosurg. 2023 Apr;172:e428-e437. doi: 10.1016/j.wneu.2023.01.046. Epub 2023 Jan 20.
Clinical trial NCT01679535: A Nutrition/Hygiene Education Program for the Prevention of Child Malnutrition in Rural Kenya
Official title: A Nutrition/Hygiene Education Program for the Prevention of Child Malnutrition in Rural Kenya
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Child Nutrition Disorders
Keywords: Infant nutrition disorder
Child nutrition disorders
Malnutrition
Protein-energy malnutrition
Lead sponsor: University of New Mexico
Sponsor class: OTHER
Collaborators: name: University of Nairobi
First posted: 2012-09-06
Enrollment: 246
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study will determine if an education program about hygiene and child feeding practices, taught by local village community health workers, will improve child growth and decrease the prevalence of childhood malnutrition in a rural region of Kenya.


Eligibility criteria: Inclusion Criteria:

* Child of a mother living in the catchment area of the study who delivered during the enrollment period

Primary outcomes:
measure: malnutrition prevalence
timeFrame: Measured when children are 24 months of age
Secondary outcomes:
measure: Child growth
timeFrame: Measured when children are 24 months of age
Other outcomes:
measure: Prevalence of diarrhea
timeFrame: Prevalence assessed when children reach 24 months of age
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
Study officials:
affiliation: University of New Mexico
name: Angelo J Tomedi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Black RE, Allen LH, Bhutta ZA, Caulfield LE, de Onis M, Ezzati M, Mathers C, Rivera J; Maternal and Child Undernutrition Study Group. Maternal and child undernutrition: global and regional exposures and health consequences. Lancet. 2008 Jan 19;371(9608):243-60. doi: 10.1016/S0140-6736(07)61690-0. No abstract available.
citation: Bhutta ZA, Ahmed T, Black RE, Cousens S, Dewey K, Giugliani E, Haider BA, Kirkwood B, Morris SS, Sachdev HP, Shekar M; Maternal and Child Undernutrition Study Group. What works? Interventions for maternal and child undernutrition and survival. Lancet. 2008 Feb 2;371(9610):417-40. doi: 10.1016/S0140-6736(07)61693-6.
citation: Dewey KG, Adu-Afarwuah S. Systematic review of the efficacy and effectiveness of complementary feeding interventions in developing countries. Matern Child Nutr. 2008 Apr;4 Suppl 1(Suppl 1):24-85. doi: 10.1111/j.1740-8709.2007.00124.x.
Clinical trial NCT02147535: Impact of CES1 Genotype on Metabolism of Methylphenidate
Official title: Impact of CES1 Genotype on Metabolism of Methylphenidate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Carboxylesterase 1 (CES1) Genotype
CES1 Activity
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: The Ministry of Science, Technology and Innovation, Denmark
name: Mental Health Centre Sct. Hans (Denmark)
name: University of Copenhagen
name: The Leiden Academic Center for Drug Research (LACDR)
name: Duke University
First posted: 2014-05-26
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine whether differences in the gene coding for the liver enzyme carboxylesterase 1 (CES1) means differences in the metabolism of methylphenidate, a CES1 dependent drug.


Eligibility criteria: Inclusion Criteria:

* \> 18 years old
* Caucasian

Exclusion Criteria:

* Chronic disease (except hay fever and eczema)
* Pregnancy
* Smoking
* High level of alcohol consumption (\> 21 units per week for men and 14 for women)
* Known allergy towards methylphenidate
* Permanent use of medication (contraception ok)

Primary outcomes:
measure: Plasma concentration of methylphenidate and ritalinic acid
timeFrame: Predose and 3 hours post-dose
Secondary outcomes:
measure: Metabolomic Profile
timeFrame: Predose/pre-meal, predose/post-meal and 3 hours post-dose
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Clinical Pharmacology, Bispebjerg University Hospital
Study officials:
affiliation: Department of Clinical Pharmacology, Bispebjerg University Hospital
name: Claus Stage, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01289535: Immune Response Analysis to Influenza Vaccine in Elderly Aged Over 65 Years
Official title: Immune Response Analysis to Influenza Vaccine in Elderly Aged Over 65 Years
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Immune Response
Keywords: Influenza vaccine
immune response
elderly
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2011-02-03
Enrollment: 750
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study is the first step in a clinical research program that aims to study the immune response to influenza vaccine in the elderly and then to propose a new method of administering the vaccine.

Influenza can cause severe complications in patients at risk (elderly and subjects vulnerable because of a chronic underlying disease). Over 90% of deaths related to influenza occur in people aged over 65 years.

Vaccination is the most effective way to prevent infection. The World Health Organization recommends annual immunization for people at risk, including all persons aged over 65 years, to reduce the risk of morbidity and mortality related to influenza.

However, the immune response to influenza vaccine appears to be lower in elderly than in young people.


Eligibility criteria: Inclusion Criteria:

* Subject aged 65 years or over
* Influenza vaccination without adjuvant, within 3 weeks and 3 months before inclusion visit
* Legal capacity to consent
* Subject had given written consent before his participation

Exclusion Criteria:

* Adjuvanted influenza vaccine (e.g: Fluad, Gripguard)
* Live vaccines within 3 weeks before and after influenza vaccination
* Inactivated vaccines within 2 weeks before and after influenza vaccination
* Chronic disease non-stabilized under treatment
* Severe malnutrition in the opinion of the investigator
* Congenital immunodeficiency
* Chemotherapy or radiotherapy over the last 6 months
* Immunosuppressive therapy or corticosteroid (daily dose of prednisone or equivalent \>/= 20 mg/d over 14 days) from 1 month before vaccination until the study visit
* Participation in another clinical study that could interfere with the present study

Primary outcomes:
measure: antibody rates after influenza vaccination
timeFrame: up to 3 months after vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Unité de Recherche Clinique en Immunologie Lyon Sud (URCI-LS) et Service d'Immunologie clinique et allergologie
Study officials:
References:
Clinical trial NCT03504735: Caduet and TLC Intervention in Metabolic Syndrome
Official title: Effect of Caduet and TLC Intervention on Metabolic Parameters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Metabolic Syndrome
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
Collaborators: name: Pfizer
name: University of Texas Southwestern Medical Center
First posted: 2018-04-20
Enrollment: 53
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the effectiveness of Caduet in addition to therapeutic life-style change (TLC) intervention in resolving metabolic syndrome fifty three individuals were randomized to TLC intervention study with or without Caduet therapy for 12 months. The participants underwent monthly visits with investigators to obtain vital signs, and to undergo TLC counseling. Metabolic parameters were measured before and after intervention.

Detailed description: Single center, investigator driven, double blinded, randomized with Caduet 5/10mg vs placebo. The participants visited with investigators on a monthly bases to evaluate the BP, weight, and obtain the waist measurements, and counseling. OGTT was performed at the beginning and the end of the study. Lipid and glucose parameters were measured 5 times in duration of the study period.

Exercise physiologists and dietitians completed the baseline evaluations and provided recommendations throughout the study period in person, via phone or e-mail: per subject preference. VO2 max was measured at the beginning and end of the study. Pedometers dispensed to encourage physical activity.

Eligibility criteria: Inclusion Criteria:

* BP ≥130/85
* Metabolic syndrome per NCEP-ATP III revised (3/5 criteria)
* Men and women age 40-65

Exclusion Criteria:

* Inability to sign a consent form.
* Unwillingness to complete the protocol for the duration of 15 months
* Unwillingness of primary care physician to participate in the program
* Patients already on hypercholesterolemia agent
* Fasting plasma glucose above 126 mg/dL or current treatment for diabetes.
* If the physician believes the patient should be started on antihypertensive regimen.
* Creatinine clearance \<50ml/min.
* Therapy with anticoagulants
* Pregnant/lactating women (pre-menopausal women should be on birth control pill)
* AST/ALT \> x3 upper limit of normal
* Evidence of cholelithiasis
* Use of oral anticoagulants
* Cancer
* Recent cardiovascular event (\<6months)
* Substance abuse
* Since there is no translator, non-English speaking subjects will not be enrolled in the study.

Primary outcomes:
measure: Resolution or improvement of metabolic syndrome.
timeFrame: 12 months
Secondary outcomes:
measure: Weight loss
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Texas
name: Nicola Abate, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01008735: Gonadal Toxicity in Women With Hodgkin Lymphoma
Official title: Observational Retrospective Study to Evaluate the Incidence of the Gonadal Toxicity in Women of Reproductive Age With Hodgkin Lymphoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hodgkin Lymphoma
Lead sponsor: Gruppo Italiano Studio Linfomi
Sponsor class: OTHER
First posted: 2009-11-06
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female patients with Hodgkin lymphoma diagnosed until 2007 in Italy will be considered eligible for this study. Cases will be identified from the archives of GISL.

Brief summary: The Gruppo Italiano Studio Linfomi has been collecting data on patients with Hodgkin Lymphoma (HL) since 1988. This archive represents a homogeneous series of consecutive patients with HL. The very long follow up and the availability of clinical and treatment data make it feasible to perform a study on the gonadal toxicity related to treatment for HL.


Eligibility criteria: Inclusion Criteria:

* Female patients in complete remission after chemotherapy for Hodgkin lymphoma
* Age ≥ 18 e \< 40 years
* Previous regular menstrual cycle
* No previous or concomitant gynecological diseases affecting reproducing function
* No other chemo-radiotherapy for other neoplasm
* Written informed consent

Exclusion Criteria:

* none

Primary outcomes:
measure: incidence of gonadal toxicity in terms of irreversible amenorrhea and infertility, in women of reproductive age with Hodgkin lymphoma treated with chemotherapy.
timeFrame: from end of treatment until date of last contact/visit
Secondary outcomes:
measure: role of a prophylactic treatment with oral contraceptives and GnRH analogs in preventing gonadal damage
timeFrame: from end of treatment until date of last contact/visit
Other outcomes:
Locations:
city: Modena
country: Italy
facility: Gruppo Italiano Studio Linfomi
Study officials:
affiliation: GISL
name: Francesco Angrilli, MD
role: STUDY_CHAIR
affiliation: GISL
name: Simona Falorio, MD
role: STUDY_CHAIR
affiliation: GISL
name: Massimo Federico, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03667235: 10 Versus 20 Minutes Treatment of Human Pericardium With Glutaraldehyde in OZAKI Procedure
Official title: 10 Versus 20 Minutes Treatment of Human Pericardium With Glutaraldehyde in OZAKI Procedure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Valve Surgery
Keywords: OZAKI technique
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2018-09-12
Enrollment: 6
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients undergoing aortic valve surgery with OZAKI technique at Universitätsspital Basel/ Switzerland

Brief summary: To compare mechanic and thermic stability of pericardium fixated either with 0.6% glutaraldehyde for 10 minutes or with 0.6% glutaraldehyde for 20 minutes

Detailed description: Autologous pericardium for aortic valve reconstruction is treated with 0.6% glutaraldehyde for 10 minutes to improve stability (OKAZI technique).

This study investigates whether treatment with 0.6% glutaraldehyde for 20 minutes improves mechanic and thermic stability of autologous pericardial tissue. Autologous pericardium remaining after aortic valve reconstruction surgery is used.

To investigate 10 versus 20 minutes treatment of removed original aortic valve tissue with glutaraldehyde as a reference.

Eligibility criteria: Inclusion Criteria:

* patients undergoing aortic valve surgery with sufficient leftover tissues from the OZAKI procedure (excess of pericardium and calcified aortic valve leaflets)

Exclusion Criteria:

* denial of consent
* insufficient leftover tissues from the OZAKI procedure
* patients after thoracic radiation or surgery

Primary outcomes:
measure: mechanic stability tests to investigate uniaxial and cyclical tensile properties
timeFrame: 4 days after surgery
measure: thermic stability by using constant force at linearly increasing temperature
timeFrame: 4 days after surgery
Secondary outcomes:
measure: histologic analysis of collagen fiber organization and quantification
timeFrame: 4 days after surgery
measure: Pronase testing to analyse enzymatic degradation
timeFrame: 4 days after surgery
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Herzchirurgie University Hospital Basel
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Oliver Reuthebuch, PD Dr. med
role: PRINCIPAL_INVESTIGATOR
References: