louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02496247: Canned Herring for Prevention of Childhood Malnutrition During the Early Rainy Season in Rural Guinea-Bissau
Official title: Effectiveness of Canned Herring for Prevention of Childhood Malnutrition During the Early Rainy Season in Rural Guinea-Bissau
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Undernutrition
Keywords: malnutrition
undernutrition
Z-score
Guinea-Bissau
food aid
Lead sponsor: Global Food & Nutrition Inc.
Sponsor class: OTHER
Collaborators: name: Alaska Seafood Marketing Institute
name: International Partnership for Human Development
First posted: 2015-07-14
Enrollment: 1200
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will test the effectiveness of a weekly village distribution of canned herring for prevention of malnutrition in children aged 2-5 years old during a food-insecure time of the year in rural villages in Guinea-Bissau. The study will use community health workers to conduct the herring distribution, making this a test that will provide valuable information on what could become a practical food aid supplementation practice. The primary study hypothesis is that distribution of canned herring as a weekly food supplement to families with young children at the beginning of the rainy season will prevent a seasonal decrease in weight-for-age Z-score (primary variable) of children with mild to moderate malnutrition at baseline.


Eligibility criteria: Inclusion Criteria:

* Village leaders willing to allow the study to take place in their village
* Village must have community health workers who are willing to do the weekly distribution of herring to enrolled families and are able to keep the necessary records documenting the distribution.
* Children age 2-5 currently living in a selected village
* Parents willing to participate in the study

Exclusion Criteria:

* There are no eligibility exclusions for this study.
* If a child is identified with severe malnutrition at the baseline measurement, the family will be advised to take the child for treatment rather than participate in the study.

Primary outcomes:
measure: Change from Baseline in weight-for-age Z-score
timeFrame: baseline, 8-10 weeks
Secondary outcomes:
measure: height-for-age Z-score
timeFrame: baseline, 8-10 weeks
measure: mid upper arm circumference (MUAC) measurement
timeFrame: baseline, 8-10 weeks
measure: weight
timeFrame: baseline, 8-10 weeks
measure: height
timeFrame: baseline, 8-10 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Global Food & Nutrition Inc.
name: Nina Schlossman
role: PRINCIPAL_INVESTIGATOR
affiliation: International Partnership for Human Development
name: Adrian Balan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06788847: Evaluating Ultrasound-Guided Needle Knife for Dupuytren's Contracture
Official title: Advancing Dupuytren's Contracture Treatment: a Clinical Prospective Study on Ultrasound-Guided Needle Knife Dissection
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dupuytren Contracture
Keywords: Ultrasound-Guided Procedure
Dupuytrene's Contracture
Tubiana Grade
Fibrotic Cords Acupotomy
Functional Hand Recovery
Palmar Fascia Fibrosis
Lead sponsor: Mansoura University Hospital
Sponsor class: OTHER
First posted: 2025-01-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants will undergo ultrasound-guided needle knife dissection for Dupuytren's Contracture treatment.
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the efficacy and safety of ultrasound-guided needle knife dissection in treating Dupuytren's contracture. The procedure is designed to improve hund function and minimize complications associated with the conventional surgical methods.

Detailed description: Dupuytren's contracture is a disease mainly characterized by the progressive fibrosis of the palmar fascia with subsequent hand deformity and dysfunction. The current study seeks to explore, through this minimally invasive technique, ultrasound-guided needle knife dissection regarding ROM and patient satisfaction. The procedure will be carried out under ultrasound guidance to ensure safety and completeness with the accuracy of precise dissection. Primary outcome measures will concern hand mobility, and secondary measures will evaluate patient self-reported satisfaction and any complications for the 6-month follow-up period.

Eligibility criteria: Inclusion Criteria:

* Participants diagnosed with Dupuytren's Contracture.
* Willing to undergo ultrasound-guided needle knife dissection

Exclusion Criteria:

* Patients who have undergone previous surgery or needle apponeurotomy for Dupuytren's Contracture on the same hand.
* Active hand infections, open wounds, or dermatological conditions in the treatment area.
* Coagulopathy or use of anticoagulant that cannot be safely paused
* Neuromuscular disorders affecting hand function
* Pregnancy or breastfeeding
* Uncontrolled systemic illnesses, such as poorly managed diabetes or cardiovascular disease.
* Known hypersensitivity to local anesthetics.

Primary outcomes:
measure: Improvement in hand Function
timeFrame: 6 months
measure: Improvement in hand mobility
timeFrame: 6 months
Secondary outcomes:
measure: Patient Satisfaction
timeFrame: 6 months
measure: Rate of procedure-related complications
timeFrame: 6 months
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University Hospital
state: Dakahlia
Study officials:
References:
Clinical trial NCT04312347: Tamoxifen Dose Adjustment on Indonesian Female ER+ Breast Cancer Patients Based on CYP2D6 Genotype and Endoxifen Levels
Official title: Tamoxifen Dose Adjustment on ER+ Breast Cancer Patients Based on Genomic and Metabolite Concentrations Analysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ER+ Breast Cancer
Keywords: breast cancer
tamoxifen
CYP2D6
endoxifen
Lead sponsor: Nalagenetics Pte Ltd
Sponsor class: INDUSTRY
First posted: 2020-03-18
Enrollment: 151
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objectives of this study is to perform CYP2D6 genotyping and metabolite concentrations analysis on ER+ breast cancer patients who are taking tamoxifen and give dose recommendations based on the CYP2D6 genotypes and endoxifen levels.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with ER+ breast cancer
* Have taken tamoxifen daily for at least 2 months

Exclusion Criteria:

* Have not taken tamoxifen daily for at least 2 months

Primary outcomes:
measure: Effects of genotype and phenotype of CYP2D6 on plasma and serum concentration of tamoxifen and its metabolites
timeFrame: 8 weeks after initial tamoxifen intake
measure: Effects of dose recommendation of tamoxifen based on CYP2D6 genotyping results on endoxifen levels
timeFrame: 8 weeks after dose recommendation
measure: Frequencies of CYP2D6 alleles in female Indonesian population
timeFrame: Baseline, pre-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: MRCCC Siloam Hospital Semanggi
state: DKI Jakarta
Study officials:
affiliation: Department of Pharmacy, University of Indonesia
name: Baitha P. Maggadani
role: PRINCIPAL_INVESTIGATOR
References:
citation: Madlensky L, Natarajan L, Tchu S, Pu M, Mortimer J, Flatt SW, Nikoloff DM, Hillman G, Fontecha MR, Lawrence HJ, Parker BA, Wu AH, Pierce JP. Tamoxifen metabolite concentrations, CYP2D6 genotype, and breast cancer outcomes. Clin Pharmacol Ther. 2011 May;89(5):718-25. doi: 10.1038/clpt.2011.32. Epub 2011 Mar 23.
citation: Fox P, Balleine RL, Lee C, Gao B, Balakrishnar B, Menzies AM, Yeap SH, Ali SS, Gebski V, Provan P, Coulter S, Liddle C, Hui R, Kefford R, Lynch J, Wong M, Wilcken N, Gurney H. Dose Escalation of Tamoxifen in Patients with Low Endoxifen Level: Evidence for Therapeutic Drug Monitoring-The TADE Study. Clin Cancer Res. 2016 Jul 1;22(13):3164-71. doi: 10.1158/1078-0432.CCR-15-1470. Epub 2016 Feb 4.
Clinical trial NCT00743847: A 6-Week Multicenter Trial Of Varenicline Tartrate For Cognitive Impairment In Subjects With Schizophrenia
Official title: A Phase 2 6-Week, Double-Blind, Placebo-Controlled, Multicenter Trial Of Varenicline Tartrate (CP-526,555) For Cognitive Impairment In Subjects With Schizophrenia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Schizophrenia
Keywords: schizophrenia, treatment, cognition
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-08-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this protocol is to assess the efficacy of two dose strengths of varenicline (0.5 mg BID and 1mg BID) as adjunctive treatment for cognitive impairment in symptomatically stable outpatient schizophrenic subjects who are receiving treatment with atypical antipsychotic medications.

A secondary objective is to evaluate the safety and tolerability of two doses of varenicline in symptomatically stable schizophrenic subjects who are receiving treatment with atypical antipsychotic medications.


Eligibility criteria: Inclusion Criteria:

* Have a current diagnosis of schizophrenia
* Subjects must be on ongoing maintenance antipsychotic monotherapy or combination therapy with risperidone, olanzapine, quetiapine, ziprasidone, aripiprazole, or paliperidone.
* Evidence of stable symptomatology ≥3 months (eg, no hospitalizations for schizophrenia, no increase in level of psychiatric care due to worsening of symptoms of schizophrenia).

Exclusion Criteria:

* Subjects with a current DSM-IV axis I diagnosis other than schizophrenia.
* Current treatment with conventional antipsychotics (e.g. fluphenazine, haloperidol) or clozapine, or the use of adjunctive anticholinergic treatment.

Primary outcomes:
measure: CNS Vital Signs Cognition Battery (CNS-VS-M) normed composite score
timeFrame: screening, wk -1, baseline, wk 1,3,6
Secondary outcomes:
measure: CNS-VS-M un-normed composite score
timeFrame: screening, wk-1,baseline,wk1,3,6
measure: CNS-VS-M un-normed and normed domain scores
timeFrame: screening, wk-1,baseline, wk1,3,6
measure: University of California San Diego Performance Skills Assessment Brief (UPSA-B) total score
timeFrame: baseline, wk 1,3,6
measure: Severity Item for Cognitive Impairment-Clinician and Patient Versions (SICI-CV; SICI-PV)
timeFrame: baseline, wk6
measure: Global Improvement in Cognition Clinician and Patient Versions (GIC-CV;GIC-PV)
timeFrame: wk 1,3,6
measure: Safety assessments, including adverse events, electrocardiographic assessments, neuropsychiatric assessments (performed weekly), physical exam, and laboratory measures
timeFrame: weekly
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00182247: D-Dimer and IPG for Recurrent Thrombosis (DIRECT)
Official title: D-Dimer and IPG for Recurrent Thrombosis (DIRECT) Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Deep Vein Thrombosis
Pulmonary Embolism
Keywords: deep vein thrombosis
DVT
pulmonary embolism
PE
venous thromboembolism
VTE
d-dimer
IPG
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Heart and Stroke Foundation of Canada
First posted: 2005-09-16
Enrollment: 600
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: To simplify and improve the diagnostic approach to patients with clinically suspected recurrent DVT by determining whether the results of the combination of IPG and d-dimer testing, using a whole blood agglutination assay, can be used in the management of such patients.


Eligibility criteria: Inclusion Criteria:

* suspected deep vein thrombosis
* history of previous DVT or PE

Exclusion Criteria:

* comorbid condition limiting survival to less than 6 months
* contraindication to contrast medium (allergy, renal dysfunction, creatinine \> 150mcmol/L)
* receiving long-term warfarin or heparin therapy
* received full-dose heparin therapy for more than 48 hours
* pregnancy
* symptomatic for pulmonary embolism
* absence of symptoms within 5 days of presentation
* geographic inaccessibility which precludes follow-up

Primary outcomes:
measure: symptomatic DVT and PE in follow-up
Secondary outcomes:
measure: death
measure: deep vein thrombosis diagnosed by venography in those
measure: randomized to that intervention
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
city: Hamilton
country: Canada
facility: McMaster University Medical Centre
state: Ontario
city: Hamilton
country: Canada
facility: St. Joseph' Hospital
state: Ontario
city: Hamilton
country: Canada
facility: Henderson General Hospital
state: Ontario
city: Hamilton
country: Canada
facility: Chedoke Hospital
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Quebec
country: Canada
facility: CHA - Pavillon Saint-Sacrement
city: Pavia
country: Italy
facility: IRCCS Policlinico S. Matteo
Study officials:
affiliation: Hamilton Health Sciences Corporation
name: Shannon Bates, M.D.
role: STUDY_CHAIR
affiliation: Hamilton Health Sciences Corporation
name: Jeffrey Ginsberg, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04367077: MultiStem Administration for COVID-19 Induced ARDS (MACoVIA)
Official title: A Phase 2/3 Study to Assess the Safety and Efficacy of MultiStem® Therapy in Subjects With Acute Respiratory Distress Syndrome (ARDS) Due to Coronavirus Disease (COVID-19)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: ARDS
Keywords: COVID19
respiratory distress
adult stem cells
Lead sponsor: Healios K.K.
Sponsor class: INDUSTRY
First posted: 2020-04-29
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: Multicenter investigation featuring an open-label lead-in followed by a double blinded, randomized, placebo-controlled Phase 2/3 part to evaluate the safety and efficacy of MultiStem therapy in subjects with moderate to severe Acute Respiratory Distress Syndrome (ARDS) due to pathogens including COVID-19.


Eligibility criteria: Inclusion Criteria:

Diagnosis of new acute-onset moderate to severe ARDS, as defined by the Berlin criteria, requiring an endotracheal or tracheal tube, Evidence of pneumonia or severe localized or systemic infection

Exclusion Criteria:

Moribund subject who, in the opinion of the Investigator, is not expected to survive at least 48 hours and End-stage severe chronic lung disease

Primary outcomes:
measure: Ventilator-Free Days
timeFrame: Day 0 through Day 28.
measure: Safety and Tolerability as measured by the incidence of treatment-emergent adverse events as assessed by CTCAE v5.0.
timeFrame: Day 28
Secondary outcomes:
measure: All-cause mortality
timeFrame: Day 60
measure: Ranked hierarchical composite outcome of alive and ventilator-free
timeFrame: Day 28
measure: Ventilator-free days
timeFrame: Day 0 through Day 60
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Athersys Investigational Site 107
state: Illinois
city: Akron
country: United States
facility: Athersys Investigational Site 103
state: Ohio
city: Cleveland
country: United States
facility: Athersys Investigational Site 101
state: Ohio
city: Cleveland
country: United States
facility: Athersys Investigational Site 102
state: Ohio
Study officials:
affiliation: Healios K.K.
name: Eric Jenkins, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04469777: Subcutaneous Injection of Erythropoietin on Visual Functions in Patients With Late Onset Optic Neuropathy
Official title: Evaluation of the Effect of Subcutaneous Injection of Erythropoietin on Visual Functions in Patients With Late Onset Optic Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Optic Neuropathy
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2020-07-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study included 20 patients diagnosed as late onset optic neuropathy that are attending Alexandria main university hospital.

All patients underwent initially assessment of visual acuity, color vision, pupil reaction ,funduscopy and electrophysiological tests ( pattern visual evoked potential and pattern electroretinogram in both eyes to use data of the normal fellow eye as patients' internal control). Systemic erythropoietin injections (eprax 10000 IU subcutaneous twice daily for three days). Follow up after one month and three months by recording visual acuity and electro physiological studies.
Primary purpose: TREATMENT

Brief summary: This study aimed to investigate the therapeutic effect of subcutaneous erythropoietin in the management of late stage optic neuropathy.

Detailed description: Injury of the optic nerve or optic neuropathy is one of the most common causes of vision loss. This study aimed to investigate the therapeutic effect of subcutaneous erythropoietin in the management of late stage optic neuropathy.

Eligibility criteria: Inclusion Criteria:

* Patients with late stage optic neuropathy (1 month to 12 months after onset of optic neuropathy due to late referral of the cases)

Exclusion Criteria:

* Patients with perforating ocular injuries were excluded.

Primary outcomes:
measure: Assessment of visual acuity
timeFrame: 3 months
measure: Flash visual-evoked potentials
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria Faculty of Medicine
Study officials:
affiliation: Alexandria Faculty of Medicine
name: Mai ElBahwash, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02206477: DMSO for Prevention of Capsular Contraction in Alloplastic Breast Reconstruction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Breast Capsular Contracture
Dimethyl Sulfoxide
Keywords: breast capsular contructure
dimethyl sulfoxide
radiotherapy
breast reconstruction
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2014-08-01
Enrollment: 110
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Capsular contraction is the one of the most common complications of both esthetic and reconstructive breast surgery, with high incidence after radiotherapy. The mechanism of the contraction is unclear, but is believed to be similar to the formation of hypertrophic scarring.

Dimethyl sulfoxide (DMSO) has demonstrated its use as an anti-inflammatory, anti-proliferative, and antibacterial agent.

The aim of this study is to test the effect of DMSO on the incidence and severity if capsular contracture after breast alloplastic reconstruction in irradiated patients.

We conduct a prospective randomized-control single-surgeon study in the tertiary academic Rabin Medical Center.

110 female candidates for mastectomy, radiotherapy and immediate two-stage reconstruction will be included. They will be divided into two groups: the DMSO treatment group, which will be treated according to our protocol, and the control group, that will be treated with the same protocol but with 0.9% saline instead.

Several measures will be taken, including: capsular contracture grading by two plastic surgeons, a VAS-score of breast pain, maximal capsular thickness (MCT) in sonography evaluation, and pathology examination of the capsule (biopsy will be taken during the second stage operation).

Rates and grades of capsular contracture evident clinically, radiologically and pathologically, will be evaluated and compared.


Eligibility criteria: Inclusion Criteria:

* female candidates for mastectomy, radiotherapy and immediate two-stage reconstruction

Exclusion Criteria:

* autologous reconstruction
* single-stage alloplastic reconstruction
* intake of steroids, anti-inflammatory, anti-coagulate or immunomodulatory medications on a regular basis
* low compliance to home treatment or follow-ups.

Primary outcomes:
measure: reduction of 50% or more in capsular contructure incidence
timeFrame: 3.5 years
Secondary outcomes:
measure: reduction in maximal capsular thickness (MCT) in sonography evaluation
timeFrame: 3.5 years
measure: evidence of less inflamation and fibrosis in pathology examination of the capsule
timeFrame: 3.5 years
measure: reduction in VAS pain score in treatment group
timeFrame: 3.5 years
Other outcomes:
Locations:
city: Petach Tikva
country: Israel
facility: Rabin Medical Center
Study officials:
affiliation: Rabin Medical Center
name: Sagit Meshulam Derazon, MD
role: PRINCIPAL_INVESTIGATOR
References: