louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03805490: Translation, Cross Cultural Adaptation and Validation of the Italian Version of the Forgotten Joint Score in Total Knee Arthroplasty
Official title: Italian Validation of the Forgotten Joint Score(Fjs 2015)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Arthroplasty
Surveys and Questionnaires
Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sponsor class: OTHER
First posted: 2019-01-15
Enrollment: 120
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of both gender, aged between 55 and 85 years old, Italian mother-tongue with unilateral gonarthrosis who need total knee prosthesis

Brief summary: This is an observational, prospective study that has the primary goal of validating the Forgotten Joint Score (FJS)

Detailed description: This is an observational, prospective study that has the primary goal of validating the Forgotten Joint Score (FJS) as described by Behrend and Giesinger in 2012. Patients will be given two self-assessment questionnaires (WOMAC and FJS) to perform internal consistency analysis, reliability and comparability of results in a population of people undergoing total knee replacement prosthetic surgery.

Comparison of data will be done for each patient by evaluating the evolution of the postoperative period, comparing the results obtained with a well known validated score (WOMAC).

Questionnaires will be given pre-operatively, at 6 month ± 2 weeks, and 12 month ± 1 weeks after surgery.

Eligibility criteria: Inclusion Criteria:

* Males and females
* Age range between 55 and 85 years
* Italian mother-tongue
* Patients with unilateral gonarthrosis who need total knee prosthesis

Exclusion Criteria:

* Patients with orthopedic pathologies of other origin
* Patients with history of previous articular prosthetic replacement surgery on joints of the lower limb.
* Patients with history of previous major cardiovascular events
* Patients who need aids for walking
* Patients claiming that they can not submit to follow-up and therefore can not complete the study

Primary outcomes:
measure: Validating the Forgotten Joint Score.
timeFrame: 18 month
Secondary outcomes:
measure: BMI
timeFrame: 18 months
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Istituto Ortopedico Galeazzi
state: MI
Study officials:
affiliation: IRCCS Istituto Ortopedico Galeazzi
name: Valerio Pascale
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sansone V, Fennema P, Applefield RC, Marchina S, Ronco R, Pascale W, Pascale V. Translation, cross-cultural adaptation, and validation of the Italian language Forgotten Joint Score-12 (FJS-12) as an outcome measure for total knee arthroplasty in an Italian population. BMC Musculoskelet Disord. 2020 Jan 11;21(1):23. doi: 10.1186/s12891-019-2985-2.
Clinical trial NCT05500690: Understanding Effects of Folic Acid on the Methylosome and Transcriptome of Women With Spina Bifida Affected Pregnancies
Official title: Understanding Effects of Folic Acid on the Methylosome and Transcriptome of Women With Spina Bifida Affected Pregnancies
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pregnancy; Spina Bifida, Fetal
Environmental Exposure
Keywords: Spina Bifida
Folic Acid
DNA Methylation
arsenic
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Neurosciences and Hospital, Dhaka
First posted: 2022-08-15
Enrollment: 69
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Folic acid is currently considered to be the standard of care for primary and secondary prevention of spina bifida, but the mechanisms underlying folic acid's benefits are unknown. One hypothesis is that folic acid changes DNA methylation and transcription of genes important in neural tube closure.

In this study, the investigators will evaluate how DNA methylation of genes associated with neural tube closure changes after a short course of standard-of-care folic acid supplementation. In addition, the investigators will assess whether environmental arsenic exposure modifies the effects of folic acid on the methylosome.

Detailed description: The investigators will encourage women who have recently had a pregnancy affected by spina bifida to take daily folic acid supplements for three months. Folic acid supplementation is considered standard of care for primary and secondary prevention of spina bifida. The investigators will compare DNA methylation in blood and folate levels before and after folic acid use.

Eligibility criteria: Inclusion Criteria:

* Women (18+) with a prior pregnancy affected by spina bifida
* Available for required study visits

Exclusion Criteria:

* Personal history of diabetes or gestational diabetes
* Current anticonvulsant medication use
* History of pregnancy affected by identified genetic syndrome associated with neural tube defect such as Trisomy 18
* Current pregnancy
* Abnormal peripheral blood film results (suggestive of megaloblastic anemia/B12 deficiency.)

Primary outcomes:
measure: Changes in DNA Methylation patterns
timeFrame: Week 1 and Week 12
Secondary outcomes:
measure: Changes in serum folate concentration
timeFrame: Week 1 and Week 12
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: National Institute of Neurosciences and Hospital
Study officials:
affiliation: Boston Children's Hospital
name: Maitreyi Mazumdar, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: National Institute of Neurosciences and Hospital, Dhaka
name: Sudipta K Mukherjee, MBBS, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01039090: Efficacy of Continuous Apomorphine Infusion on Cognitive and Neuropsychological Functions in Parkinson's Disease
Official title: Prospective, Randomised, Comparative Study Comparing Efficacy of Continuous Apomorphine Infusion Versus Usual Dopaminergic Per os Treatment on Cognitive and Neuropsychological Functions in Parkinson's Disease: a Clinical and PET-scan Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parkinsons's Disease
Keywords: Not eligible for deep brain stimulation
Parkinsons's patients
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2009-12-24
Enrollment: 21
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: In Parkinson's disease, treatment mainly aims to improve motor functions. However, other dysfunctions are often observed in Parkinson's patients, and may have important consequences on the quality of life of patients.

Cognitive and neuropsychological troubles may be observed, as memory impairment or anxiety for example. As this kind of troubles is worrying for the patient himself (herself) and his/her family, treatment needs to take into account those troubles in addition to motor difficulties. In our centre, we have already used continuous Apomorphine infusions among Parkinson's patients and it seems to have good results. The present study aims to objectively assess the efficacy of continuous Apomorphine infusions on cognitive and neuropsychological functions in Parkinson's disease using clinical and positron emission tomography (PET)-scan measures.


Eligibility criteria: Inclusion Criteria:

* Age 18 and more
* Parkinson's disease according to UKPDSBB diagnosis criteria
* Motor difficulties in spite of dopaminergic per os treatment
* Not eligible for deep brain stimulation for one or more reasons (age\>70, axial troubles in spite of dopaminergic per os treatment, cognitive troubles and/or hallucinations)

Exclusion Criteria:

* Mattis scale \< 120
* Contraindication to Apomorphine (liver insufficiency, severe cognitive troubles, allergy, pregnancy, neuroleptic treatment)
* Contraindication to Fluoro-Deoxy-Glucose which is used in PET-Scan (allergy, kidney failure, pregnancy, breast feeding)

Primary outcomes:
measure: Neuropsychological results: Montgomery-Åsberg Depression Rating Scale (MADRS), The Lille Apathy Rating Scale (LARS), Spielberger
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rennes
country: France
facility: Rennes University Hospital
Study officials:
affiliation: Rennes University Hospital
name: Marc VERIN, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Auffret M, Le Jeune F, Maurus A, Drapier S, Houvenaghel JF, Robert GH, Sauleau P, Verin M. Apomorphine pump in advanced Parkinson's disease: Effects on motor and nonmotor symptoms with brain metabolism correlations. J Neurol Sci. 2017 Jan 15;372:279-287. doi: 10.1016/j.jns.2016.11.080. Epub 2016 Dec 2.
Clinical trial NCT00447590: Effectiveness and Safety Study of LAP-BAND Treatment for Obese Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Morbid Obesity
Lead sponsor: Apollo Endosurgery, Inc.
Sponsor class: INDUSTRY
First posted: 2007-03-15
Enrollment: 153
Sex: ALL
Minimum age (years): 14
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether the LAP-BAND system is safe and effective in morbidly obese adolescents.

Detailed description: The primary objective of this study was to evaluate the safety and effectiveness of the LAP-BAND System in a morbidly obese adolescent population, ages 14 to 17 years. The secondary objectives were to assess associated changes from baseline in obesity-related comorbidities as well as psychosocial functioning.

Eligibility criteria: Inclusion Criteria:

* Between the ages of 14 and 17 at the time of enrollment
* Have a BMI ≥ 40 kg/m2 (with or without obesity-related co-morbid conditions) or BMI ≥ 35 kg/m2 with one or more severe co-morbid conditions
* Have a history of obesity for at least 2 years and have failed more conservative weight-reduction alternatives, such as supervised diet, exercise and behavior modification programs

Exclusion Criteria:

* Family or subject history of congenital or acquired anomalies of the gastrointestinal tract
* Severe cardiopulmonary or other serious or uncontrolled organic disease
* Severe coagulopathy; hepatic insufficiency or cirrhosis
* History of bariatric, gastric, or esophageal surgery
* History of intestinal obstruction or adhesive peritonitis
* History of esophageal dysmotility disorders
* Type I diabetes

Primary outcomes:
measure: Percent of Subjects Who Attain Clinically Successful Weight Loss of ≥30% Excess Weight Loss (EWL) at 1 Year Post LAP-BAND Implantation.
timeFrame: 1 year
Secondary outcomes:
measure: Subject Excess Weight Loss Throughout the Study
timeFrame: Baseline to 5 Years
measure: Subject Percent Excess BMI Loss
timeFrame: Baseline to 5 Years
measure: Change in Subjects' Comorbid Conditions
timeFrame: Baseline to 5 Years
measure: Change in Quality of Life Using the Beck Depression Inventory II (BDI)
timeFrame: Baseline to 5 Years
measure: Change in Quality of Life Using Impact of Weight on Quality of Life (IWQOL) Kids Questionnaire
timeFrame: Baseline to 5 Years
Other outcomes:
Locations:
city: Austin
country: United States
facility: Apollo Endosurgery
state: Texas
Study officials:
affiliation: Apollo Endosurgery, Inc.
name: Apollo Endosurgery
role: STUDY_DIRECTOR
References:
Clinical trial NCT06665490: Pilot Study to Characterize the Microbiome in Cutaneous T Cell Lymphoma Skin Lesions Before and After Use of CLn® Skin Care Body Wash
Official title: Pilot Study to Characterize the Microbiome in Cutaneous T Cell Lymphoma Skin Lesions Before and After Use of CLn® Skin Care Body Wash
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cutaneous T Cell Lymphoma
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2024-10-30
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with mycosis fungoides (MF) will be enrolled at Northwestern Memorial Hospital Dermatology outpatient clinic at 676 N St. Clair Street, Suite 1600, Chicago, IL 60611.

Brief summary: In this pilot study of patients with mycosis fungoides, the most common form of CTCL, we propose to primarily evaluate the impact of daily use of the CLn Body Wash (dilute sodium hypochlorite (0.006% NaOCl)) on the microbiota of CTCL lesions. Should dilute sodium hypochlorite body wash improve the microbiome of MF, reducing the abundance of S. aureus, future, larger studies can more fully evaluate the impact on pruritus, erythema, scaling, disease evolution and its role in CTCL management.


Eligibility criteria: Inclusion Criteria:

* Adults ages 18-89 years of age with active mycosis fungoides.
* Patients with concurrent and prior malignancies are allowed as long as any concurrent malignancy does not directly involve the same skin site.

Exclusion Criteria:

* Patients currently or recently (within past 4 weeks) on topical or systemic antibiotics, pregnant persons, or persons with potential of becoming pregnant or are/will be breastfeeding
* Patients that have initiated a new skin-directed therapy over the past month.

Primary outcomes:
measure: Reduction of S. aureus skin microbiome
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Department of Dermatology
state: Illinois
Study officials:
affiliation: Northwestern University
name: Alan Zhou
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04513990: Novel Point-of-Care Diagnostic Test for SARS-CoV-2 (COVID-19)
Official title: Evaluation of a Novel Point-of-Care Diagnostic Test for SARS-CoV-2
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COVID-19 Infection
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: William Marsh Rice University
First posted: 2020-08-14
Enrollment: 257
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study investigates a new diagnostic test in detecting SARS-CoV-2, the virus that causes the disease COVID-19. This may help to improve testing for COVID-19.

Detailed description: PRIMARY OBJECTIVE:

I. To evaluate the clinical performance of a novel point-of-care diagnostic test for detecting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes the disease called coronavirus disease 19 (COVID-19).

SECONDARY OBJECTIVES:

I. To compare the clinical performance of provider-collected nasopharyngeal samples with self-collected nasal swab, cheek swab, and saliva sample using the novel SARS-CoV-2 diagnostic test.

II. To measure viral load and evaluate the role of viral load in COVID-19 severity.

OUTLINE:

Participants undergo collection of nasopharyngeal (back of the nose) samples by a medical provider and self-collection of oral, saliva, and nasal samples.

After completion of study, participants are followed up at 1 month.

Eligibility criteria: Inclusion Criteria:

* Qualifies for SARS-CoV-2 testing at MD Anderson, Lyndon B. Johnson (LBJ) hospital, or affiliated sites (may include MD Anderson and LBJ patients and employees) according to institutional criteria at time of enrollment
* Willing and able to provide informed consent
* Ability to perform protocol-required activities
* Able to speak and read English or Spanish

Exclusion Criteria:

* Patient or provider decision not to perform SARS-CoV-2 testing

Primary outcomes:
measure: Sensitivity of diagnostic test
timeFrame: Up to 1 year
measure: Specificity of diagnostic test
timeFrame: Up to 1 year
measure: Concordance of the novel point-of-care diagnostic test
timeFrame: Up to 1 year
measure: Positive predictive value (PPV) of the novel point-of-care diagnostic test
timeFrame: Up to 1 year
measure: Negative predictive value (NPV) of the novel point-of-care diagnostic test
timeFrame: Up to 1 year
Secondary outcomes:
measure: Viral load metrics
timeFrame: Up to 1 month
measure: Disease progression
timeFrame: Up to 1 month
Other outcomes:
Locations:
city: Houston
country: United States
facility: Lyndon Baines Johnson General Hospital
state: Texas
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Kathleen M Schmeler
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00082290: Massage Therapy in Treating Patients With Cancer Pain
Official title: Massage for the Treatment of Pain in Cancer: A Randomized Phase II Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain
Unspecified Adult Solid Tumor, Protocol Specific
Keywords: unspecified adult solid tumor, protocol specific
pain
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2004-05-06
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: RATIONALE: Massage therapy may help lessen pain caused by cancer.

PURPOSE: This randomized phase II trial is studying how well massage therapy works in treating patients with cancer pain.

Detailed description: OBJECTIVES:

* Determine whether the effects of massage therapy in patients with cancer pain are sufficiently promising to warrant a definitive trial.
* Determine the feasibility of a definitive trial.

OUTLINE: This is a randomized, controlled, pilot study. Patients are stratified according to in-patient status (yes vs no) and first baseline pain score ≥ 7 (yes vs no). Patients are randomized to 1 of 3 treatment arms.

* Arm I (massage therapy): Patients receive a light touch ("Reiki") massage over 45 minutes.
* Arm II (volunteer visit control): Patients receive a 45-minute visit from a trained volunteer who will be available to sit quietly or talk with the patient to discuss issues of concern, as desired by the patient. Volunteers will not touch the patient except to pat their shoulder or briefly hold their hand.
* Arm III (quiet time control): Patients receive 45 minutes of quiet time. Pain and mood are assessed at baseline, immediately after treatment, at 6 hours and 24 hours after treatment, and then daily for the next 5 days after treatment.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of cancer
* Baseline pain score ≥ 2 on a 0-10 rating scale where 0 = no pain
* Pain syndrome must be the result of cancer and/or cancer treatment

  * No postoperative or other acute procedural pain

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Concurrent pharmacologic pain therapy allowed

Primary outcomes:
measure: reduction in pain
timeFrame: 24 hours after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Barrie R. Cassileth, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01325090: Early Administration of Botox® in Neuropathic Pain Due to Thoracoscopy or Thoracotomy
Official title: Early Administration of Botulinum Toxin Type A (Botox®) in Neuropathic Pain Due to Thoracoscopy or Thoracotomy: a Randomized, Double Blind, Placebo Controlled Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Pain Due to Certain Specified Procedures
Neuropathic Pain
Keywords: neuropathic pain due to thoracotomy
Neuropathic Pain Due to Thoracoscopy
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2011-03-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Botulinum toxin type A has been reported to inhibit the release of various pain neurotransmitters (SP, CGRP, glutamate) responsible for neurogenic inflammation, a process that results from the sensitization of C-fiber nociceptors (peripheral sensitization). This action is probably responsible for the analgesic effect of botulinum toxin type A recently demonstrated in patients with neuropathic pain of peripheral origin.In those studies, patients had been suffering for years. The investigators can hypothesizes that earlier administration of Botox in the course of neuropathic pain might prevent central sensitization, that is secondary to peripheral sensitization. The investigators can hope to increase efficacy of Botulinum toxin type A injections and to prevent chronification of pain.


Eligibility criteria: Inclusion Criteria:

* daily pain, for 3 months, secondary to thoracoscopy or thoracotomy, of neuropathic origin (DN4 questionary)

Exclusion Criteria:

* contraindications for botulinum toxin

Primary outcomes:
measure: decrease in average pain intensity as measured by the Brief Pain Inventory (BPI)
timeFrame: one month
Secondary outcomes:
measure: VAS in the last 24 hours
timeFrame: 24 hours
measure: Neuropathic Pain Inventory
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Limoges
name: Danièle RANOUX, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05638490: Study on Prenatal Diagnosis and Closed-loop Management System of Congenital Talipes Equinovarus
Official title: Congenital Talipes Equinovarus Prenatal Diagnosis and Closed Loop Management System Single Center Observational Prospective Study Clinical Study Protocol
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prenatal Diagnosis and Closed-loop Management System of Congenital Talipes Equinovarus
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
First posted: 2022-12-06
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Single pregnant women with "congenital talipes equinovarus" suggested by ultrasound in our hospital; Voluntary prenatal diagnosis; Those who voluntarily participate in this subject and can comply with the requirements of doctors; Voluntary interview with interviewees:

Brief summary: The study intends to establish a closed-loop management from prenatal to postnatal through prospective cohort, and comprehensively utilize ultrasound and MRI technology to establish a prenatal diagnosis and evaluation system for congenital talipes equinovarus. On the basis of existing genetic testing, further use of whole-exome sequencing and other genomic methods to explore possible pathogenic genes and loci, and clarify the pathogenic mechanism of congenital talipes equinovarus. Therefore, congenital talipes equinovarus can improve its diagnosis and treatment capacity, reduce the disability rate related to congenital talipes equinovarus, and prevent it well.


Eligibility criteria: Inclusion Criteria:

1）Single pregnant women 2) "congenital talipes equinovarus" suggested by ultrasound

Exclusion Criteria:

Twin or multiple pregnancies

Primary outcomes:
measure: Genetic testing results of congenital talipes equinovarus
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Drum Tower hospital
state: Jiangsu
Study officials:
References: