louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01451671: Development of a Prenatal Test for Fetal Aneuploidy Detection
Official title: Prenatal Test for Fetal Aneuploidy Detection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fetal Complications
Keywords: fetal
aneuploidy
non-invasive
prenatal
cell free DNA
Lead sponsor: Roche Sequencing Solutions
Sponsor class: INDUSTRY
First posted: 2011-10-14
Enrollment: 1500
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women carrying a fetus with an abnormal chromosomal condition that has been confirmed by invasive testing.

Brief summary: This is an observational study to develop and evaluate a blood based prenatal blood test. Pregnant women confirmed to be carrying a fetus with a chromosomal abnormality will be eligible. Subjects will be asked to provide a blood sample and a limited amount of clinical data that will be recorded on a case report form. All samples and clinical data will be stripped of subject identifiers prior to submission to Ariosa.


Eligibility criteria: Inclusion Criteria:

* Subject has singleton pregnancy
* Subject is confirmed via invasive testing to be carrying a fetus with a chromosomal abnormality
* Subject is able to provide informed consent
* Subject is ≥ 18 years of age

Exclusion Criteria:

* Subject is pregnant with more than one fetus
* Subject (mother) has a known aneuploidy

Primary outcomes:
measure: Identification of aneuploidy
timeFrame: At enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California San Diego
state: California
city: Louisville
country: United States
facility: Norton Healthcare
state: Kentucky
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Ariosa Diagnostics
name: Tracy Roberts
role: STUDY_DIRECTOR
References:
Clinical trial NCT02283671: Treatment of Multiple Sclerosis and Neuromyelitis Optica With Regulatory Dendritic Cell: Clinical Trial Phase 1 B
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Multiple Sclerosis
Neuromyelitis Optica
Lead sponsor: Fundacion Clinic per a la Recerca Biomédica
Sponsor class: OTHER
First posted: 2014-11-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: First in human study to assess the tolerability and safety profile of treatment with dendritic cell in patients with multiple sclerosis or neuromyelitis optica.


Eligibility criteria: Inclusion Criteria:

* patients with Multiple sclerosis or neuromyelitis optica
* diagnosed more than a year before inclusion
* Expanded Disability Status Scale between 3.0 and 8.5
* all subtypes of multiple sclerosis or Neuromyelitis optica
* Multiple Sclerosis patients who have previously been offered therapeutic alternatives available in indications and either decline or that after receiving treatment for at least 6 months have had an outbreak or an increase of at least 1 point on the Expanded Disability Status Scale (EDSS) (non-responders) or who have not tolerated treatment
* Patients with Neuromyelitis optica (NMO) in stable immunomodulatory treatment in the past 6 months or without treatment because they are not candidates to receive it

Exclusion Criteria:

* Corticosteroid treatment in the last 30 days
* Presence of an outbreak in the last month
* Inability to perform brain Magnetic resonance imaging (with paramagnetic contrast)
* Serious systemic diseases, including Hepatitis B virus, Hepatitis C Virus, and Human Immunodeficiency Virus. Uncontrolled hypertension, insulin-dependent diabetes mellitus, heart disease or kidney failure or severe respiratory
* Personal history of cancer or family history of known hereditary cancer
* patient participating in other experimental study in the last 3 months
* women childbearing-aged that do not use effective contraceptive methods
* pregnant or breastfeeding women

Primary outcomes:
measure: number of patients with adverse events
timeFrame: after 12 weeks of follow up
Secondary outcomes:
measure: Multiple Sclerosis Functional Composite scale
timeFrame: after 12 weeks of follow up
measure: Multiple Sclerosis Spasticity Scale
timeFrame: after 12 weeks of follow up
measure: Expanded Disability Status Scale
timeFrame: after 12 weeks of follow up
measure: SF36 Health Status questionnaire
timeFrame: after 12 weeks of follow up
measure: EuroQol5D
timeFrame: after 12 weeks of follow up
measure: Changes in immunological profile
timeFrame: after 12 weeks of follow up
measure: number of disease outbreaks
timeFrame: after 12 weeks of follow up
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic of Barcelona
Study officials:
affiliation: Institut d'Investigacions Biomèdiques August Pi i Sunyer
name: Pablo Villoslada, MD PhD
role: STUDY_CHAIR
References:
Clinical trial NCT04184271: Pharmacokinetics of Advantage Arrest
Official title: Pharmacokinetics of Advantage Arrest
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dental Caries
Keywords: adult
fluoride
silver
silver diamine fluoride
pharmacokinetics
Lead sponsor: Advantage Silver Dental Arrest, LLC
Sponsor class: INDUSTRY
Collaborators: name: University of Washington
First posted: 2019-12-03
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open label exposure--response study
Primary purpose: TREATMENT

Brief summary: The study aim is to characterize the kinetics of silver and fluoride after topical application of silver diamine fluoride.

Detailed description: The purpose of this study is to characterize basic PK parameters (Cmax, t1/2, AUC, and total urinary recovery) to contribute to evidence for the safety of Advantage Arrest, consistent with Guidance for Industry--Exposure--Response Relationships (April 2003).

Eligibility criteria: Inclusion Criteria:

* 18 years or older, minimum 20 teeth, healthy, not taking prescription or OTC medications

Exclusion Criteria:

* pregnant, weighed less than 50 kg, had oral mucositis or ulcerative lesions, known sensitivity to silver or fluoride

Primary outcomes:
measure: Observed Fluoride Urinary Recovery
timeFrame: baseline to 24 hours
measure: Observed Silver Tmax
timeFrame: baseline, 30 minutes, and 1, 2, 3, 4, 6, 8, 12, and 24 hours
measure: Observed Silver Cmax
timeFrame: baseline, 30 minutes, and 1, 2, 3, 4, 6, 8, 12, and 24 hours
measure: Observed Silver Baseline-Corrected Cmax
timeFrame: baseline, 30 minutes, and 1, 2, 3, 4, 6, 8, 12, and 24 hours
measure: Observed Silver t1/2
timeFrame: baseline, 30 minutes, and 1, 2, 3, 4, 6, 8, 12, and 24 hours
measure: Observed Silver 24 Hour Urinary Concentration
timeFrame: baseline to 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington Institute of Translational Health Sciences
state: Washington
Study officials:
affiliation: University of Washington
name: Peter Milgrom, DDS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lin YS, Rothen ML, Milgrom P. Pharmacokinetics of 38% topical silver diamine fluoride in healthy adult volunteers. J Am Dent Assoc. 2019 Mar;150(3):186-192. doi: 10.1016/j.adaj.2018.10.018.
Clinical trial NCT04868071: Effects of Low-Speed and High-Speed Resistance Training Programs on Frailty Status
Official title: Effects of Low-Speed and High-Speed Resistance Training Programs on Frailty Status, Physical Performance, Cognitive Function, and Blood Pressure in Prefrail and Frail Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frailty
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
First posted: 2021-04-30
Enrollment: 122
Sex: ALL
Minimum age (years): 60
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present study refers to a three-arm randomized controlled trial that investigated the effects of two types of RT on frailty status, physical performance, cognitive function, and blood pressure of prefrail and frail older adults.


Eligibility criteria: Inclusion Criteria:

* a) aged 60 years or over; b) were prefrail or frail according to Fried's criteria; c) performed the sit-to-stand test alone, with a mobility aid, or researcher's help; d) possessed sufficient physical and cognitive abilities to perform exercise sessions; and e) had a physician authorization to participate.

Exclusion Criteria:

* Exclusion criteria included having participated in a structured physical exercise training program in the past six months, prescription of hormone replacement therapy and/or psychotropic drugs, and any unstable cardiovascular event (e.g., myocardial infarction) or complication in the past 6 months.

Primary outcomes:
measure: Frailty Status
timeFrame: 16 weeks
measure: Physical Performance
timeFrame: 16 weeks
measure: Cognitive Function
timeFrame: 16 weeks
measure: Blood Pressure
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Poá
country: Brazil
facility: Cantinho do Idoso Senior Center
state: SP
city: Poá
country: Brazil
facility: Mãe Maria Nursing Home
state: SP
Study officials:
References:
citation: Coelho-Junior HJ, Uchida MC. Effects of Low-Speed and High-Speed Resistance Training Programs on Frailty Status, Physical Performance, Cognitive Function, and Blood Pressure in Prefrail and Frail Older Adults. Front Med (Lausanne). 2021 Jul 26;8:702436. doi: 10.3389/fmed.2021.702436. eCollection 2021.
Clinical trial NCT06740071: The Application of Somatosensory Interactive Pelvic Floor Muscle Training for Stress Urinary Incontinence in Men Underwent Radical Prostatectomy
Official title: The Application of Somatosensory Interactive Pelvic Floor Muscle Training for Stress Urinary Incontinence in Men Underwent Radical Prostatectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer (Post Prostatectomy)
Keywords: pelvic floor muscle training
post operative urinary incontinence
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Ruijin Hospital
First posted: 2024-12-18
Enrollment: 100
Sex: MALE
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: The study aims to compare the efficacy of different pelvic floor muscle training (PFMT) modes on improving urinary incontinence (UI) recovery in prostate cancer (PCa) patients after radical prostatectomy (RP). The methods being compared include standard PFMT (S-PFMT) , a somatosensory interactive PFMT (SI-PFMT, an enhanced PFMT) , and a standard PFMT combined with pelvic floor muscle magnetic stimulation (S-PFMT+MS). Eligible participants are randomized into either of the groups to receive different modalities of post-operative PFMT.

Subjects in the S-PFMT group received traditional verbal instructions and paper-based educational materials. For the SI-PFMT group, an interactive experiential education model was adopted. First, an educational video introduced the importance and basic information of postoperative PFMT. Then, synchronized PFMT guidance through a combination of audio and video would be used. Subjects assigned to the S-PFMT+MS group, on the basis of traditional verbal and paper-based education, pelvic floor magnetic stimulation therapy was applied using a pelvic floor magnetic stimulator, operated by the same experienced rehabilitation physician.

Self administered questionnaires and 1-hour pad test would be used to assess the treatment outcomes at 1, 3, and 6 months postoperatively.


Eligibility criteria: Inclusion Criteria:

* PCa patients aged 18 to 85 years who had undergone laparoscopic radical prostatectomy (RP)

Exclusion Criteria:

* patients currently participating in other clinical trials and those unable to cooperate with study interventions and follow-up procedures due to specific factors

Primary outcomes:
measure: International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)
timeFrame: 1, 3, and 6 months postoperatively.
Secondary outcomes:
measure: urine leakage volume from the 1-hour pad test
timeFrame: 1, 3, and 6 months postoperatively
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital
state: Shanghai
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
Study officials:
References:
Clinical trial NCT06933771: Children's Blood Draws: Lavender Study
Official title: The Effectiveness of Lavender Essence in Reducing Pain and Fear in Children During Blood Draws; A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nursing Caries
Pain Management
Keywords: PAİN
FEAR
Lead sponsor: Corlu State Hospital
Sponsor class: OTHER_GOV
First posted: 2025-04-18
Enrollment: 102
Sex: ALL
Minimum age (years): 7
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: LAVENDER ESSENCE GROUP - CONTROL GROUP
Primary purpose: PREVENTION

Brief summary: The aim of this study is to show the effect of lavender scent used to reduce pain and fear during blood collection in children aged 7-14.

Detailed description: The children in the experimental group were given lavender scent before the blood collection procedure. No additional intervention was made to the children in the control group. The pain and fear scores of both groups were evaluated.

Eligibility criteria: Inclusion Criteria:

children between the ages of 7-14 who applied to the blood collection unit, who had no mental neurological, hearing, speech, vison disorders

Exclusion Criteria:

who were not allergic to lavender essence, who were not diagnosed with asthma, allergies, epilepsy, dermatitis who had not taken analgesics in the last 6 hours were included in the study

Primary outcomes:
measure: Child Medical Fear Scale (CMFS)
timeFrame: 9 MONTHS
measure: Wong-Baker FACES Pain Rating Scale (WBFPRS)
timeFrame: 9 MONTHS
Secondary outcomes:
Other outcomes:
Locations:
city: Merkez
country: Turkey
facility: Çorlu State Hospital
state: Tekirdağ
Study officials:
References:
Clinical trial NCT01759693: Platelet Activation in Chronic Inflammatory Skin Diseases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Urticaria
Atopic Dermatitis
Keywords: Platelet activation
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2013-01-03
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospital clinic

Brief summary: Platelets are blood cells that are important in coagulation of the blood. These cells have recently been shown to play a role in a number of other biologic processes, for example inflammation. In this study the investigators will determine the extent of platelet activation in people suffering from common chronic skin inflammation-urticaria and allergic dermatitis.


Eligibility criteria: Inclusion Criteria: Urticaria or atopic dermatitis -

Exclusion Criteria:Lack of informed consent

-

Primary outcomes:
measure: Platelet activation
timeFrame: 6 months
Secondary outcomes:
measure: Mean platelet volume
timeFrame: 6 months
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medical Center
Study officials:
References:
Clinical trial NCT04883593: A Study Comparing the Efficacy of TA103 and the Placebo Control in the Treatment of Interdigital Tinea Pedis.
Official title: A Multi-center, Double-blind, Randomized, Placebo Controlled, Parallel-Group Study, Comparing TA103 and Placebo Control in the Treatment of Tinea Pedis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Tinea Pedis
Lead sponsor: Taro Pharmaceuticals USA
Sponsor class: INDUSTRY
First posted: 2021-05-12
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate and compare the safety and efficacy of TA103 in the treatment of tinea pedis.

Detailed description: A multi-center, double-blind, randomized, placebo controlled, parallel-group study, comparing TA103 and the placebo control in the treatment of tinea pedis.

Eligibility criteria: Inclusion Criteria:

* Healthy male or non pregnant female aged ≥ 18 years
* Subjects must have provided IRB approved written informed consent
* Subjects must have clinical diagnosis of interdigital tinea pedis with lesions localized to the interdigital spaces or predominantly interdigital, but may extend to other areas of the foot (the non-interdigital lesions should not be hyperkeratotic, i.e., characteristic of tinea pedis moccasin).

Exclusion Criteria:

* Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.
* Subjects with a history of hypersensitivity or allergy to any of the study medication ingredients and its excipients.
* Confluent, diffuse moccasin-type tinea pedis of the entire plantar surface.

Primary outcomes:
measure: The proportion of subjects with complete cure at Week 6 (+/- 4 days) following treatment (study day 38-46)
timeFrame: Baseline to Week 6 Visit
Secondary outcomes:
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Catawba Research, LLC
state: North Carolina
Study officials:
affiliation: Catawba Research
name: Zaidoon A. Al-Zubaidy
role: STUDY_DIRECTOR
References:
Clinical trial NCT01987193: Feasibility Study of Tumor Blood Flow Measurement by Detection of Positron Activation Post Proton Therapy (DS01)
Official title: Feasibility Study of Tumor Blood Flow Measurement by Detection of Positron Activation Post Proton Therapy
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Brain Cancer
Prostate Cancer
Lung Cancer
Keywords: Proton radiation
tumor blood flow
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2013-11-19
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients treated at radiation oncology clinic

Brief summary: The purpose of this study is the development of noninvasive (having no direct contact) detector and electronic system that will directly measure tumor blood flow rate.


Eligibility criteria: Inclusion Criteria:

Solid tumors in the intracranial, thoracic, or pelvic regions.

Exclusion Criteria: N/A

-

Primary outcomes:
measure: Patients with hypoxic tumor identified by tumor blood flow measurement.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: University of Florida Proton Therapy Institute
state: Florida
Study officials:
affiliation: University of Florida Proton Therapy Institute
name: Zhong Su, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04137393: The Effect of Brushing With Salvadorapersica (Miswak) Sticks on Salivary Streptococcus Mutants and Plaque Level in Children: A Clinical Trial
Official title: The Effect of Brushing With Salvadorapersica (Miswak) Sticks on Salivary Streptococcus Mutants and Plaque Level in Children: A Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Plaque, Dental
Lead sponsor: King Abdulaziz University
Sponsor class: OTHER
First posted: 2019-10-24
Enrollment: 70
Sex: MALE
Minimum age (years): 8
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Objectives:

to evaluate the effect of brushing with Salvadora persica (Miswak) on streptococcus mutants compared to brushing with fluoridated tooth paste (FTP) in children.

Methods:

A total of 94 healthy children (8 years old) from an elementary governmental school in Jeddah, Saudi Arabia were grouped to Miswak and FTP groups. They were assessed for their salivary level of mutans streptococci species, and lactobacillus at the baseline and three weeks after brushing. Caries level using DMFT/dmft, and plaque amount using Greene Vermillion simplified oral hygiene index were recorded.


Eligibility criteria: Inclusion Criteria:

* Healthy children
* age from 8 to 9
* parents signed the consent form they attended morning session for brushing

Exclusion Criteria:

* medical compromised children
* parents did not sign the consent form Did not attend morning session

Primary outcomes:
measure: green and vermillion
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Sabbagh HJ, AlGhamdi KS, Mujalled HT, Bagher SM. The effect of brushing with Salvadora persica (miswak) sticks on salivary Streptococcus mutans and plaque levels in children: a clinical trial. BMC Complement Med Ther. 2020 Feb 13;20(1):53. doi: 10.1186/s12906-020-2847-3.