louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00386763: Efficacy and Safety of the Pediatric Formulation of Artemether- Lumefantrine in Children With Uncomplicated P. Falciparum Malaria.
Official title: A Randomized, Investigator-Blinded, Multicenter, Parallel-Group Study to Compare Efficacy, Safety and Tolerability of Arthemeter/ Lumefantrine Dispersible Tablet Formulation vs. Artemether/ Lumefantrine 6-Dose Crushed Tablet in the Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria in Infants and Children.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Malaria
Falciparum
Keywords: Marsh fever
Plasmodium infections
Remittent fever
Paludism
Artemether
Artemisinins
Malaria
Benflumetol
Lumefantrine
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-10-12
Enrollment: 890
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and efficacy of artemether-lumefantrine against uncomplicated malaria caused P. falciparum in children of 5-35 kg bodyweight.


Eligibility criteria: Inclusion Criteria:

* male or female infants and children ≤12 years of age
* body weight of ≥5 kg and \<35 kg,
* with a confirmed diagnosis of uncomplicated malaria caused by the P. falciparum parasite

Exclusion Criteria:

* complicated malaria
* persistent vomiting
* malaria due to parasites other than P. falciparum
* antimalarial treatment received in the past 2 weeks
* known chronic disease e.g. positive HIV status, severe cardiac, renal, or hepatic disease

Primary outcomes:
measure: Proportion of patients free of parasites at day 28.
Secondary outcomes:
measure: Proportion of patients free of parasites at 7 days and at 14 days
measure: Time to clearance from parasites
measure: Time to clearance of fever
measure: Hematology and biochemistry parameters
measure: Electrocardiogram
Other outcomes:
Locations:
city: Benin
country: Benin
facility: Novartis
city: Kenya
country: Kenya
facility: Novartis
city: Mali
country: Mali
facility: Novartis
city: Mozambique
country: Mozambique
facility: Novartis
city: Tanzania
country: Tanzania
facility: Novartis
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_CHAIR
References:
citation: Belard S, Ramharter M, Kurth F. Paediatric formulations of artemisinin-based combination therapies for treating uncomplicated malaria in children. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD009568. doi: 10.1002/14651858.CD009568.pub2.
citation: Abdulla S, Sagara I, Borrmann S, D'Alessandro U, Gonzalez R, Hamel M, Ogutu B, Martensson A, Lyimo J, Maiga H, Sasi P, Nahum A, Bassat Q, Juma E, Otieno L, Bjorkman A, Beck HP, Andriano K, Cousin M, Lefevre G, Ubben D, Premji Z. Efficacy and safety of artemether-lumefantrine dispersible tablets compared with crushed commercial tablets in African infants and children with uncomplicated malaria: a randomised, single-blind, multicentre trial. Lancet. 2008 Nov 22;372(9652):1819-27. doi: 10.1016/S0140-6736(08)61492-0. Epub 2008 Oct 14.
Clinical trial NCT02956863: The Effect of Osteopathic Treatment in Pain and Functionality Individuals With Chronic Neck Pain
Official title: The Effect of Osteopathic Manipulative Treatment in Pain and Functionality Individuals With Nonspecific Chronic Neck Pain: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Lead sponsor: Instituto Brasileiro de Osteopatia
Sponsor class: OTHER
First posted: 2016-11-06
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether manipulative osteopathic treatment associated exercises improves pain and function in individuals with chronic non-specific neck pain

Detailed description: The purpose of this study is to determine whether manipulative osteopathic treatment associated exercises improves pain and function in individuals with chronic non-specific neck pain Design: a randomized single blind placebo controlled trial will be conducted trial. Patients (n=40) with non-specific neck pain will be randomized to receive 1) osteopathic manipulative treatment and exercise (n=20) or 2) exercise alone (n=20). Participants will receive 8 treatments during 4 weeks.

Clinical outcomes will be obtained at 1 week, four weeks and 24 weeks after end of treatment.

Methods:

The primary outcome will be pain measured by 11-point numerical pain rating scale.

The secondary outcome will be disability measured by the Neck Disability Index, range of motion measured by Cervical Range of Motion device, Pressure pain threshold measured by electronic algometer.

Eligibility criteria: Inclusion Criteria:

Symptoms of chronic neck pain does not specify that persists for more than 3 months

Exclusion Criteria:

individuals who report inflammatory previous surgery, spondylolisthesis, spinal stenosis, herniated disc, radiculopathy, fracture and musculoskeletal degenerative diseases. , Cancer, neurological diseases, pregnancy. They will be excluded participants who received some form of manipulative treatment in the last three months.

Primary outcomes:
measure: Pain intensity
timeFrame: 30 days after end treatment
Secondary outcomes:
measure: range of motion
timeFrame: 30 days after end treatment
measure: Pressure pain threshold
timeFrame: 30 days after end treatment
measure: functionality and disability
timeFrame: 30 days after end treatment
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Sandro Groisman
state: RS
Study officials:
affiliation: IBO Brazilian Osteopathic Institute
name: Sandro Groisman, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02253563: Resistance Versus Balance Training in Parkinson's Disease
Official title: Resistance Training Versus Balance Training to Improve Postural Control in Patients With Parkinson's Disease - a Randomized Controlled Rater Blinded Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Lead sponsor: University of Kiel
Sponsor class: OTHER
First posted: 2014-10-01
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison of resistance training versus balance training to improve postural control in patients with Parkinson's Disease


Eligibility criteria: Inclusion Criteria:

* idiopathic Parkinson's Disease, postural instable

Exclusion Criteria:

* cardiopulmonary/metabolic diseases that could interfere with the safe conduct of the study protocol, unstable medication, severe cognitive impairments that do not allow the patients to follow exercise instructions, participation in a resistance or balance training program (beside usual physical therapy), Deep Brain Stimulation.

Primary outcomes:
measure: Fullerton Advanced Balance scale
timeFrame: up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Schlenstedt C, Paschen S, Kruse A, Raethjen J, Weisser B, Deuschl G. Resistance versus Balance Training to Improve Postural Control in Parkinson's Disease: A Randomized Rater Blinded Controlled Study. PLoS One. 2015 Oct 26;10(10):e0140584. doi: 10.1371/journal.pone.0140584. eCollection 2015.
Clinical trial NCT02547363: Efficacy and Safety of LEO 43204 in Field Treatment of Actinic Keratosis on Balding Scalp Including 12-month Follow-up
Official title: Efficacy and Safety of LEO 43204 in Field Treatment of Actinic Keratosis on Balding Scalp Including 12-month Follow-up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Actinic Keratosis
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2015-09-11
Enrollment: 373
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 the trial is to compare the short term efficacy of LEO 43204 gel with vehicle gel in AK on the balding scalp when applied topically once daily for 3 consecutive days as field treatment.


Eligibility criteria: Inclusion Criteria:

* Subjects with 5 to 20 clinically typical, visible and discrete AKs within a treatment area of sun-damaged skin on the full balding scalp (the balding part of the scalp should be greater than 25 cm2 (4 in2) and up to approximately 250 cm2 (40 In2)
* Subjects with minimum 3 clinically typical, visible and discrete AKs within a tracking area of 50 cm2 (8 In2). The tracking area must be within the treatment area

Exclusion Criteria:

* Location of the treatment area (full balding scalp) within 5 cm of an incompletely healed wound or within 5 cm of a suspected BCC or SCC
* Treatment with ingenol mebutate gel in the treatment area within the last 12 months
* Lesions in the treatment area that have: atypical clinical appearance (e.g. hyperthrophic, hyperkeratotic or cutaneous horns) and /or, recalcitrant disease (e.g. did not respond to cryotherapy on two previous occasions)
* History or evidence of skin conditions other than the trial indication that would interfere with the evaluation of the trial medication (e.g. eczema, unstable psoriasis, xeroderma pigmentosum)

Primary outcomes:
measure: Percentage of Participants With Complete Clearance of Actinic Keratosis (AK)
timeFrame: At Week 8
Secondary outcomes:
measure: Percentage of Participants With Partial Clearance of AKs
timeFrame: At Week 8
measure: Percentage of Participants With Partial Clearance of AKs
timeFrame: At Week 4
measure: Percent Reduction in AK Count in the Treatment Area Compared to Baseline
timeFrame: At Week 8
Other outcomes:
Locations:
city: Smithtown
country: United States
facility: Long Island Skin Cancer & Dermatologic Surgery
state: New York
Study officials:
affiliation: Long Island Skin Center
name: Daniel M Siegel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06043063: Local Anesthesia Before Bulkamid Injection
Official title: Post-procedural Pain Associated With Periurethral Block at Time of Bulkamid Injection for SUI: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stress Urinary Incontinence
Intrinsic Sphincter Deficiency
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 23
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: While recommended pre-anesthesia for polyacylamide hydrogel (PAHG, Bulkamid) injections for stress urinary incontinence and intrinsic sphincter deficiency can include intraurethral anesthetic gel with or without periurethral block, there is no existing literature to guide choice of anesthesia. This is a single-blinded randomized control trial to evaluate post-procedure pain with choice of anesthesia before PAHG injection.


Eligibility criteria: Inclusion Criteria:

* Women ≥ 18 years old with stress urinary incontinence, intrinsic sphincter deficiency, or stress-predominant mixed urinary incontinence desiring PAHG
* English-speaking
* Scheduled in outpatient clinic or OR without sedation, general, or neuraxial anesthesia

Exclusion Criteria:

* Pregnancy
* Neurogenic bladder
* Pre-existing need for intermittent catheterization or indwelling catheter
* Bladder or urothelial malignancy
* Prior radiation to pelvic floor
* Known allergy/sensitivity to PAHG

Primary outcomes:
measure: Visual analog scale (VAS) for pain
timeFrame: Ascertained at end of procedure (withdrawal of cystoscope)
Secondary outcomes:
measure: Duration of procedure
timeFrame: Ascertained at end of procedure (within 5 minutes of withdrawal of cystoscope)
measure: Incomplete bladder emptying
timeFrame: Ascertained on day-of-procedure (within 1 hour of withdrawal of cystoscope)
measure: Need for re-injection of PAHG
timeFrame: Assessed at follow-up 2 weeks post-procedure
measure: International Consultation on Incontinence Questionnaire for Urinary Incontinence (ICIQ-UI)
timeFrame: Assessed at baseline and at two-week and twelve-week follow-up visit
measure: Patient Global Impression of Improvement scale (PGI-I)
timeFrame: Assessed at two-week and twelve-week follow-up visit
Other outcomes:
Locations:
city: Washington
country: United States
facility: MedStar Georgetown University Hospital
state: District of Columbia
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Washington
country: United States
facility: MedStar Lafayette Medical Centre
state: District of Columbia
Study officials:
References:
Clinical trial NCT01082263: Midazolam Drug-Drug Interaction Study With Lurasidone HCl
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Schizophrenia Patients
Keywords: DDI study between Midazolam and Lurasidone HCl
Male and Female
Lead sponsor: Sumitomo Pharma America, Inc.
Sponsor class: INDUSTRY
First posted: 2010-03-08
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: A Phase I, Drug-Drug Interaction Study between Midazolam and Lurasidone HCl.

Detailed description: lurasidone 120 mg, midazolam 5 mg

To compare the single-dose pharmacokinetic profile of midazolam 5 mg when administered alone vs. when administered with a single-dose of lurasidone 120 mg.

To compare the single dose pharmacokinetic profile of midazolam 5 mg when administered alone vs. when administered after steady state dosing with lurasidone 120 mg.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorders
2. Females who participate in this study:

   are unable to have children -OR- are willing to remain abstinent from Day -5 to 90 days after discharge; -OR- are willing to use an effective method of double-barrier birth control from Day -5 to 90 days after discharge.
3. Males must be willing to remain sexually abstinent or use an effective method of birth control from Day -5 to 90 days after discharge.
4. Able and agree to remain off of prior antipsychotic medication for the duration of the study.

Exclusion Criteria:

1. Known presence or history of renal or hepatic insufficiency.
2. A history or presence of abnormal electrocardiogram (ECG5. Known history or presence of clinically significant intolerance to antipsychotic medications.
3. Significant orthostatic hypotension (i.e. a drop in systolic blood pressure of 30 mmHg or more and/or drop in diastolic blood pressure of 20 mmHg or more on standing).
4. Presence or history (within the last year) of a medical or surgical condition (e.g. gastrointestinal disease) that might interfere with the absorption, metabolism, or excretion of orally administered lurasidone.
5. Participated in another clinical trial or receiving an investigational product within 30 days prior to drug administration.
6. Use of concomitant medications that prolong the QT/QTc interval within 14 days prior to Day -5 to follow-up including but not limited to those listed in Appendix 19.5.
7. Received depot neuroleptics unless the last injection was at least 1 treatment cycle before Day -5.
8. Difficulty fasting or consuming the FDA high fat meals.
9. At risk with midazolam dosing with respiratory disease or impaired gag reflex, in the opinion of the investigator.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Culver City
country: United States
facility: CCT/Parexel
state: California
Study officials:
affiliation: CCT/Parexel
name: Marina Bussel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04824963: Analysis of Related Factors Affecting the Secondary Implantation of Intraocular Lens in Congenital Cataract
Official title: Analysis of Related Factors Affecting the Secondary Implantation of IOLs in Congenital Cataract
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Congenital Cataract
Keywords: secondary implantation
ciliary sulcus
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Congenital cataract patient accepted secondary IOLs implantation at Eye hospital of Wenzhou Medical University.

Brief summary: The ocular biometric parameters of the children with congenital cataract including preoperative pupil diameter, corneal diameter, axial length, anterior and posterior capsule size, iris adhesion. And then analysis whether the preoperative parameters were correlated with the implantation site of secondary implantation.


Eligibility criteria: Inclusion Criteria:

* Patients were diagnosed as congenital cataract without lens after surgery
* Secondare IOLs implantation surgery was performed in Eye hospital of Wenzhou Medical University

Exclusion Criteria:

* Suffers from uveitis, glaucoma and other ocular diseases

Primary outcomes:
measure: pupil diameter
timeFrame: Before lens implantation
measure: posterior capsule diameter
timeFrame: Before lens implantation
Secondary outcomes:
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: Eye Hospital of Wenzhou Medical College
state: Zhejiang
Study officials:
affiliation: Ophthalmology and Optometry Hospital
name: Yune Zhao
role: STUDY_DIRECTOR
References:
Clinical trial NCT03639363: 4% Chlorhexidine Gluconate Daily Bathing for Prevention of Hospital-acquired Infections in Intensive Care Settings
Official title: Study on the Effect of the Universal Decontamination With Daily Bathing With 4% Chlorhexidine Gluconate on the Incidence of Hospital Acquired Infections in Intensive Care Units
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hospital Infection
Keywords: 4% chlorhexidine gluconate
infection control
Lead sponsor: University Of Perugia
Sponsor class: OTHER
Collaborators: name: Fondazione Toscana Gabriele Monasterio
First posted: 2018-08-21
Enrollment: 449
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study will assess the utility of 4% chlorhexidine gluconate (CHG) daily bathing to reduce hospital acquired infections in patients admitted to intensive care units. One group will be daily bathed with 4% CHG and the other group with standard soap.


Eligibility criteria: Inclusion Criteria:

* admission to the intensive care unit (ICU) or to the post-operative cardiosurgical ICU (PC-ICU)
* ICU/PC-ICU stay for at least 1 night

Exclusion Criteria:

* known allergy to chlorhexidine
* burns, toxic epidermal necrolysis or Stevens-Johnson syndrome as admission diagnosis
* pregnancy

Primary outcomes:
measure: hospital acquired infections incidence
timeFrame: infections occured 48 hours after admission to ICU/PC-ICU
Secondary outcomes:
measure: Ventilator-associated pnemonias (VAP) incidence
timeFrame: infections occured 48 hours after admission to ICU/PC-ICU
measure: Bloodstream infections (BSI) incidence
timeFrame: infections occured 48 hours after admission to ICU/PC-ICU
measure: central-line associated BSI (CLABSI) incidence
timeFrame: infections occured 48 hours after admission to ICU/PC-ICU
measure: urinary tract infections (UTI) incidence
timeFrame: infections occured 48 hours after admission to ICU/PC-ICU
measure: catheter associated UTI (CAUTI) incidence
timeFrame: infections occured 48 hours after admission to ICU/PC-ICU
measure: 4% CHG daily bathing safety
timeFrame: at discharge, approximately up to 10 days
measure: 4% CHG daily bathing-related adverse events
timeFrame: at discharge, approximately up to 10 days
measure: time till infection
timeFrame: at discharge, approximately up to 10 days
Other outcomes:
Locations:
Study officials:
affiliation: Infectious Diseases Clinical, University Hospital of Perugia, Perugia, Italy
name: franco baldelli, Professor
role: STUDY_CHAIR
References:
citation: Pallotto C, Fiorio M, De Angelis V, Ripoli A, Franciosini E, Quondam Girolamo L, Volpi F, Iorio P, Francisci D, Tascini C, Baldelli F. Daily bathing with 4% chlorhexidine gluconate in intensive care settings: a randomized controlled trial. Clin Microbiol Infect. 2019 Jun;25(6):705-710. doi: 10.1016/j.cmi.2018.09.012. Epub 2018 Sep 26.
Clinical trial NCT06505863: Quality of Life After Transanal Total Mesorectal Excision Compared to Traditional Total Mesorectal Excision
Official title: Does Transanal Total Mesorectal Excision (taTME) Result in Better Quality of Life and Functional Outcomes Than Traditional Total Mesorectal Excision? a Retrospective Propensity Score-adjusted Cohort Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Rectal Cancer
Quality of Life
Functional Outcome
Surgery
Keywords: Transanal total mesorectal excision
Laparoscopic total mesorectal excision
Lead sponsor: Cantonal Hospital of St. Gallen
Sponsor class: OTHER
First posted: 2024-07-17
Enrollment: 250
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: Patients receiving elective total mesorectal excision followed by reconstruction with anastomosis for primary rectal cancer at the Cantonal hospital of St.Gallen, Switzerland.

Brief summary: The improvement in prognosis of rectal cancer through modern therapy modalities rises questions regarding quality of life (QoL) and functional outcomes. Evidence for long-term QoL and functional outcomes of transanal total mesorectal excision (taTME) is not provided in current literature. This study will compare short-term and long-term QoL and functional outcomes after taTME compared to traditional abdominal TME (laparoscopic, robotic, and open approach)

Detailed description: Quality of life and functional outcomes of patients undergoing taTME or abTME for stage I-III rectal cancer will be analysed. A retrospective propensity score-adjusted analysis of prospectively conducted data will be performed. The primary endpoint QoL will be assessed by the European Organization for Research and Treatment of Cancer core questionnaire (EORTC QLQ-C30). Secondary endpoints are the functional outcomes according to the EORTC QLQ-C30 questionnaire.

Eligibility criteria: Inclusion Criteria:

* elective total mesorectal excision followed by reconstruction with anastomosis for primary rectal cancer

Exclusion Criteria:

* diagnoses other than rectal cancer
* recurrent rectal cancer
* partial mesorectal excision
* discontinuity resection (no anastomosis)
* incomplete TNM staging information
* metastatic cancer
* 30-day mortality
* lack of quality of life data
* patient decline
* age under 18 years

Primary outcomes:
measure: Quality of life (QoL)
timeFrame: 5 years after initial operation
Secondary outcomes:
measure: Functional outcomes
timeFrame: 5 years after initial operation
Other outcomes:
Locations:
city: Saint-Gall
country: Switzerland
facility: Cantonal Hospital of St.Gallen
Study officials:
affiliation: Cantonal Hospital of St. Gallen
name: Walter Brunner, PD Dr. med.
role: STUDY_DIRECTOR
References:
citation: Heald RJ. The 'Holy Plane' of rectal surgery. J R Soc Med. 1988 Sep;81(9):503-8. doi: 10.1177/014107688808100904. No abstract available.