louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00244439: Safety and Efficacy of a Novel Malathion Formulation in the Treatment of Head Lice
Official title: A Multi-Center Phase III Study to Evaluate MALG, a Novel Malathion 0.05%Formulation, for the Control of Head Lice in Pediatric and Adult Subjects With Pediculosis Capitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lice Infestations
Keywords: Head Lice
Pediculosis capitis
Lead sponsor: Taro Pharmaceuticals USA
Sponsor class: INDUSTRY
First posted: 2005-10-26
Enrollment: 360
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Current treatments for head lice include over-the-counter products such as permethrin and prescription products such as OVIDE (malathion 0.5%) lotion. In a previous phase II study, a novel, easy-to-use malathion 0.5% formulation was found to be a safe treatment for head lice. The current study will compare the efficacy and safety of this novel formulation of malathion with OVIDE and with an over-the-counter permethrin product.


Eligibility criteria: Inclusion Criteria:

* Confirmed active head lice infestation
* Patient, parent or guardian must be able to apply the treatment
* Entire household must be screened
* All infested persons must agree to participate

Exclusion Criteria:

* Allergy to pediculicides, hair care products or chrysanthemums
* Scalp conditions other than head lice
* Previous head lice treatment within the past 4 weeks
* Female patients who are pregnant or nursing

Primary outcomes:
measure: Cure of Head Lice
timeFrame: 4 weeks
Secondary outcomes:
measure: Safety of treatments
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Investigator Site
state: Arizona
city: Miami
country: United States
facility: Investigator Site
state: Florida
city: St. Petersburg
country: United States
facility: Investigator Site
state: Florida
city: West Palm Beach
country: United States
facility: Investigator Site
state: Florida
city: New York
country: United States
facility: Investigator Site
state: New York
city: Miamiville
country: United States
facility: Investigator Site
state: Ohio
Study officials:
References:
Clinical trial NCT04305639: The Reliability and Validity of Turkish Version of ''The Dyspnea-ALS-Scale (DALS-15)"
Official title: The Reliability and Validity of Turkish Version of ''The Dyspnea-ALS-Scale (DALS-15)"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Amyotrophic Lateral Sclerosis
Dyspnea
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
Collaborators: name: Istanbul University - Cerrahpasa
name: Istanbul University
First posted: 2020-03-12
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are diagnosed with Amyothrophic Lateral Sclerosis

Brief summary: The Dyspnea-ALS-Scale (DALS-15) is a uni-dimensional scale to measure dyspnea in patients with Amyotrophic Lateral Sclerosis. It can be easily and rapidly applied. The aim of this study is to investigate reliability and validity of Turkish version of the DALS-15.


Eligibility criteria: Inclusion Criteria:

* Age of 18 or above
* Dyspnea on exertion, dyspnea at rest, or orthopnea without evidence of pulmonary or cardiac causes of dyspnea

Exclusion Criteria:

* Severe cognitive dysfunction

Primary outcomes:
measure: The Dyspnea-ALS-Scale (DALS-15)
timeFrame: 10 minutes
Secondary outcomes:
measure: Modified Borg Scale
timeFrame: 10 minutes
measure: Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R)
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Faculty of Medicine
Study officials:
affiliation: Istanbul Medeniyet University
name: ESMA NUR KOLBAŞI, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01939639: The Influence of Oxytocin on the Processing of Social Contact
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Male Volunteers
Keywords: Oxytocin
fMRI
Lead sponsor: University Hospital, Bonn
Sponsor class: OTHER
First posted: 2013-09-11
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Social touch can convey the most potent and salient of socio-emotional signals. While the hypothalamic peptide oxytocin (OXT) has been identified as a key neurochemical mediator of grooming in some other social species, its modulatory influence on human interpersonal touch is unknown. The investigators expect that OXT augments the hedonic value of touch and that this behavioral effect is paralleled at the neural level by an increased response in brain areas mediating rewarding aspects of social touch.


Eligibility criteria: Inclusion Criteria:

Healthy male volunteers

Exclusion Criteria:

Current or past psychiatric disease Current or past physical illness Psychoactive medication Tobacco smokers

Primary outcomes:
measure: Pleasantness ratings of social touch
timeFrame: 30 minutes after the nasal spray administration
measure: Blood-oxygen-level dependent signal in response to social touch
timeFrame: 30 minutes after the nasal spray administration
Secondary outcomes:
measure: Questionnaire measurement of mood (PANAS) and anxiety (STAI).
timeFrame: 15 minutes before the nasal spray administration and (on average) 10 minutes after the fMRI experiment
Other outcomes:
measure: Saliva oxytocin concentrations
timeFrame: 15 minutes before the nasal spray administration and (on average) 10 minutes after the fMRI experiment
Locations:
city: Bonn
country: Germany
facility: Department of Psychiatry, University of Bonn
state: North Rhine-Westphalia
Study officials:
References:
Clinical trial NCT05231239: Transcranial Direct Current Stimulation to Reduce Chronic Pelvic Pain in Endometriosis
Official title: Transcranial Direct Current Stimulation to Reduce Chronic Pelvic Pain in Endometriosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Endometriosis
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2022-02-09
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In the study it will be tested whether transcranial direct current stimulation can reduce the perception of pelvic pain in patients with endometriosis.

Hypothesis: Transcranial direct current stimulation can reduce the perception of pelvic pain in patients with patients with endometriosis.


Eligibility criteria: Inclusion Criteria:

Endometriosis Chronic pain (more than 3 months) Pain (VAS \> 3/10)

Exclusion Criteria:

- Contraindication to transcranial direct current stimulation Pregnancy Sever internal or psychiatric condition

Primary outcomes:
measure: Pelvic pain via pressure pain threshold
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charite University Medicine
Study officials:
affiliation: Charite University Medicine Berlin, Germany, 12200
name: Magdalena S Prüß, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03196739: Feasibility of Virtual Reality Games Using Head-mounted Display on Patients With Brain Disorders
Official title: Feasibility of Virtual Reality Games Using Head-mounted Display on Patients With Brain Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Upper Extremity Dysfunction
Brain Diseases
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2017-06-23
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Because virtual reality can provide more enriched environment, repetitive goal-oriented tasks, and increased patients' interest and motivation, it is expected to stimulate neuroplasticity of injured brain and promote recovery in patients with brain disorders. On the other hand, immersive virtual reality using a head-mounted display has not yet been attempted in the rehabilitation of patients with brain disorders. In addition to the benefits of existing virtual reality or game rehabilitation, immersive virtual reality can further enhance brain plasticity, such as the effect of mirror therapy or action observation, through self-awareness of the body in the virtual space. The purpose of this study is to investigate the feasibility of applying the immersive virtual reality using a head-mounted display in patients with upper extremity dysfunction due to brain disorders.


Eligibility criteria: Inclusion Criteria:

* Patients with upper extremity dysfunction due to brain disorders (eg, stroke, traumatic brain injury, brain tumor, etc.)
* Patient who can move the upper limb against the gravity (MRC grade 3 or above in both shoulder and elbow flexion)
* Patient who can maintain stable sitting position
* Adults over 18 years old
* Patients who voluntarily agreed to participate in the study

Exclusion Criteria:

* A moderate-to-severe cognitive impairment score of 18 or less in Mini-Mental Status Examination (MMSE)
* Peripheral nerve injury, joint disease, other diseases of the upper extremity dysfunctions other than brain disorders
* Patients with a history of severe dizziness or epilepsy
* Patients with other medical illness that are difficult to participate in the study

Primary outcomes:
measure: Change of Action Research Arm Test
timeFrame: at study completion, an average of 1 month
Secondary outcomes:
measure: Change of Box and Block Test
timeFrame: at study completion, an average of 1 month
measure: Change of Modified Barthel Index
timeFrame: at study completion, an average of 1 month
measure: Time of participation
timeFrame: at study completion, an average of 1 month
measure: Patient's satisfaction
timeFrame: at study completion, an average of 1 month
measure: Patient's discomfort
timeFrame: at study completion, an average of 1 month
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Korea Workers' Compensation & Welfare Service Incheon Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT06656039: A Multimodal Predictive Recurrence Score for Patients With Clear Cell Renal Cell Carcinoma
Official title: Development and Validation of a Multimodal Predictive Recurrence Score for Patients With Clear Cell Renal Cell Carcinoma: a Multicenter Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Cell Carcinoma, Clear Cell
Keywords: Renal Cell Carcinoma
Multimodal
Artificial Intelligence
Prognosis
Deep Learning
Multicentre Study
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital of Anhui Medical University
name: The Fourth Affiliated Hospital of Harbin Medical University
name: Second Affiliated Hospital of Soochow University
name: Qianfoshan Hospital
name: Chang Gung Memorial Hospital
First posted: 2024-10-24
Enrollment: 1200
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: Pathologically confirmed postoperative patients with renal clear cell carcinoma of TNM stage I-III

Brief summary: The main goal of this observational study is to construct a predictive recurrence model for renal clear cell carcinoma through an artificial intelligence multimodal algorithm, which will improve the prognosis and survival time of ccRCC patients by helping clinicians to formulate individualised follow-up and to screen for appropriate adjuvant therapy candidates.


Eligibility criteria: Inclusion Criteria:

* Patients with malignant renal tumours must have postoperative pathological confirmation of renal clear cell carcinoma with pathological TNM stage Ⅰ-Ⅲ;
* Have available preoperative imaging
* Have available post-operative pathological paraffin samples or HE-stained tissue sections
* Must agree to and be able to comply with the study's visit schedule and other requirements as specified in the protocol, including follow-up visits by telephone

Exclusion Criteria:

* The patient's tumour type cannot be determined on the basis of histopathological sections
* Simultaneous combination of primary tumours at other sites;
* No regular follow-up imaging data
* Cases in which other factors led the investigator to believe that enrolment was inappropriate
* Cases that met all the inclusion criteria of the appeal and did not meet all the exclusion criteria were selected for this study

Primary outcomes:
measure: Disease free survival
timeFrame: "Baseline, immediately after the surgery", "Tumour recurrence or further follow-up", "Three months after surgery", "Six months after surgery", "Every year after surgery, at least follow-up 2years, up to 10 years"
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT02317939: Home Monitoring of Patients With Rheumatoid Arthritis - an eHealth Development Study
Official title: Home Monitoring of Patients With Rheumatoid Arthritis - an eHealth Development Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Lead sponsor: Parker Research Institute
Sponsor class: OTHER
Collaborators: name: Charles University, Czech Republic
name: Region Capital Denmark
First posted: 2014-12-17
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A two-step multi-centre study with 240 rheumatoid arthritis patients.

Detailed description: A two-step multi-centre study containing:

A test-retest study including 180 patients filling in questionnaires and performing joint assessments to assess reliability of patient generated data

AND

An agreement study focusing on questionnaires and joint assessments performed by 60 patients, a medical student, a physician and by an ultrasound-examinator assessing agreement between the four assessors

Eligibility criteria: Inclusion Criteria:

* Diagnosed with RA ≥ 12 months
* DAS28-CRP \< 5,1

Exclusion Criteria:

* Dementia or other linguistic/cognitive/physical deficiency that prevents participation
* Vision impairment that prevents the use of the devices and computer

Primary outcomes:
measure: Intrarater reliability of DAS28 done by patients
timeFrame: Baseline
Secondary outcomes:
measure: Interrater agreement of DAS28CRP
timeFrame: Baseline
measure: Intrarater reliability of joints counts performed by patients
timeFrame: Baseline
measure: Intrarater reliability of joint scores performed by patients
timeFrame: 8 weeks
measure: Inter- and intrarater realiabilty of DAS38
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Frederiksberg
country: Denmark
facility: Department of Rheumatology
state: Capital Region
Study officials:
affiliation: Parker RI
name: Hennning Bliddal, MD, DMSc
role: STUDY_DIRECTOR
affiliation: Parker RI
name: Henrik R Gudbergsen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Skougaard M, Bliddal H, Christensen R, Ellegaard K, Nielsen SM, Zavada J, Oreska S, Krogh NS, Holm CC, Hetland ML, Vencovsky J, Rogind H, Taylor PC, Gudbergsen H. Patients with Rheumatoid Arthritis Acquire Sustainable Skills for Home Monitoring: A Prospective Dual-country Cohort Study (ELECTOR Clinical Trial I). J Rheumatol. 2020 May 1;47(5):658-667. doi: 10.3899/jrheum.181362. Epub 2019 Aug 15.
Clinical trial NCT03430739: Effect of Usage Time of Helmet in Babies With Deformational Plagiocephaly
Official title: Investigating the Optimal Usage Time of Helmet in Babies With Deformational Plagiocephaly
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non Synostotic Plagiocephaly
Keywords: Deformational Plagiocephaly, Orthotics, Helmet
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2018-02-13
Enrollment: 28
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Babies using helmet due to deformational plagiocephaly.

Brief summary: Investigating the optimal usage time of helmet therapy is the aim of the study. Participants will be babies with deformational plagiocephaly. Plagiocephalometric assesments will be utilize to follow improvement of head symmetry. Scales asking sensational integration and severity of plagiocephaly will also be used. Time of daily usage will be follow with daily asking the caregivers how long the baby wear the helmet in a day. Participants will follow for three months.

Detailed description: Investigating the optimal usage time of helmet therapy is the aim of the study. Participants will be babies with deformational plagiocephaly. Plagiocephalometric assesments will be utilize to follow improvement of head symmetry. Scales asking sensational integration and severity of plagiocephaly will also be used. Time of daily usage will be follow with daily asking the caregivers how long the baby wear the helmet in a day. Participants will follow for three months. After the follow period completed, participants will be allocated two groups; avarage using 15-18 hours a day and avarage using 19-23 hours a day. Results will be compared for the two groups and correlation between the time of usage and cranial symmetry will be compare.

Eligibility criteria: Inclusion Criteria:

have deformational plagiocephaly consent from caregivers age between 1 day to 7 months

Exclusion Criteria:

have another systemic, neurologic or orthopedic problem

Primary outcomes:
measure: plagiocephaly severity scale
timeFrame: Change from Baseline in head asymmetry at 6th weeks of treatment, at the end of the treatment/12th weeks
Secondary outcomes:
measure: Hemispheric asymmetry
timeFrame: Change from Baseline in head asymmetry at 6th weeks of treatment, at the end of the treatment/12th weeks
Other outcomes:
Locations:
city: Edirne
country: Turkey
facility: Trakya University
Study officials:
References:
Clinical trial NCT06162039: Prevalence of Hemorrhagic Myocardial Infarction in the United States
Official title: Prevalence of Hemorrhagic Myocardial Infarction in the United States
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myocardial Infarction
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2023-12-08
Enrollment: 24181
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 STEMI who underwent primary coronary intervention and revascularisation

Brief summary: Registry analysis for prevalence of hemorrhagic myocardial infarction in the United States


Eligibility criteria: Inclusion Criteria:

* Acute Myocardial Infarction - STEMI Primary PCI Availability of lab parameters and/or CMR

Primary outcomes:
measure: Statewise proportion of Hemorrhagic Myocardial Infarction in the United States
timeFrame: 10 years
Secondary outcomes:
measure: Statewise proportion of Acute Heart Failure in Hemorrhagic Myocardial Infarction
timeFrame: 30 days
measure: Statewise proportion of re-hospitalization in Hemorrhagic Myocardial Infarction
timeFrame: 30 days
measure: Statewise proportion of arrhythmia in Hemorrhagic Myocardial Infarction
timeFrame: 30 days
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Krannert Cardiovascular Research Center
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: Rohan Dharmakumar, PhD
role: STUDY_DIRECTOR
affiliation: Indiana University School of Medicine
name: Keyur P Vora, MD FACC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03087539: Exploratory P2 Trial to Evaluate Efficacy and Safety of Clotinab® (Abciximab) in Acute MI Patients
Official title: Exploratory Phase II Clinical Trial to Evaluate the Efficacy and Safety of Clotinab® (Abciximab) in Acute Myocardial Infarction Patients: Multicenter, Randomized, Double Blind, Placebo-controlled and Parallel Group Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Acute Myocardial Infarction
Lead sponsor: ISU Abxis Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-03-22
Enrollment: 146
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Exploratory Phase II Clinical Trial to Evaluate the Efficacy and Safety of Clotinab® (Abciximab) in Acute Myocardial Infarction Patients: Multicenter, Randomized, Double-Blind, Placebo-controlled and Parallel Group Trial

Detailed description: This study was an exploratory phase 2 of Clinical Trial to evaluate the efficacy and safety of Clotinab® (Abciximab) in the acute myocardial infarction patients and was designed as a multicenter, randomized, double-blinded, placebo-controlled and parallel group study. The objective of this phase 2 clinical trial is to evaluate correlation between infarct size and major adverse cardiac event (MACE) of acute myocardial infarction patient, prearranged for percutaneous coronary intervention(PCI), to measure possibility to use infarct size as a primary efficacy test variable in phase 3 for final confirmation of safety and efficacy.

Also to determine exploratively an average variance estimation of infarct size between study drug and placebo to confirm safety and efficacy of study drug, compared to placebo and to use the estimation for calculating sample size for phase III clinical trial.

Eligibility criteria: Inclusion criteria

1. Patients with acute myocardial infarction having ST segment, 1 mm or above, from at least 2 consecutive segment.
2. Patients have a plan of Percutaneous Coronary Intervention (PCI)

Exclusion criteria

1. History of myocardial infarction
2. History of hypersensitivity in aspirin, heparin, or protein drugs
3. Bleeding disorders
4. Thrombocytopenia (\<100,000unit/㎕)
5. Cardiogenic shock, chronic atrial fibrillation, and cancer
6. Patients with following criteria: Implanted pacemakers, defibrillators, intracranial metallic implants, pregnant, etc
7. Had a history of surgical operation within 4 weeks
8. Participated in other clinical trials within 2 months

Primary outcomes:
measure: Correlation between the Infarct size and MACE
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University
state: Chonnam
Study officials:
affiliation: Chonnam National Univ.
name: Myungho Jeong
role: PRINCIPAL_INVESTIGATOR
References: