louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02638311: 99th Percentile Upper Reference Limit (URL) for the Meritas Troponin I Test
Official title: Using Normal Volunteer Whole Blood or Plasma Samples to Establish the 99th Percentile Upper Reference Limit (URL) for the Meritas Troponin I Test
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome
Lead sponsor: Trinity Biotech
Sponsor class: INDUSTRY
First posted: 2015-12-23
Enrollment: 769
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Males and females \>21 years of age from diverse geographical locations and ethnicity-dispersed populations with an equal gender distribution

Brief summary: Prospective multicenter sample collection and testing study.

Detailed description: Prospective multicenter sample collection and testing study. Approximately 750 apparently healthy subjects, including healthy subjects with stable co-morbidities, age, gender and ethnicity dispersed will be eligible for enrollment

Eligibility criteria: Inclusion Criteria:

1. Male or female at least 21 years of age at the time of enrollment in the study.
2. Subjects with no medications or no changes in their medications in the last 3 months.
3. Subjects with and without chronic stable morbidities (i.e., renal insufficiency, hypertension, diabetes, hypercholesterolemia, pulmonary disorders, coronary disease, musculoskeletal disorders, etc.).
4. Subjects able to understand and sign the informed consent and the patient questionnaire.

Exclusion Criteria:

1. Subjects with a history of heart failure and/or, having received treatment for heart failure.
2. Subject with renal failure.
3. Subjects with a history of unstable heart disease or angina complaints.
4. Subjects with any change in their medication in the last 3 months (diabetics may have small variations in glucose medications but may not have unstable disease, or have suffered a diabetic crisis in the last 6 months).
5. Any known acute infection in the last 30 days.
6. Marathon runners or extreme athletes.
7. Pregnant (self-reported).

Primary outcomes:
measure: 99th percentile for Troponin results determined from whole blood and plasma in apparetly healthy volunteer population
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Charleston
country: United States
facility: Medical Research South
state: South Carolina
city: Layton
country: United States
facility: Tanner Clinic
state: Utah
Study officials:
affiliation: Trinity Biotech
name: Jim Rock
role: STUDY_DIRECTOR
References:
Clinical trial NCT05234411: Ketonemia Through Menstrual Cycle
Official title: Ketonemia Through Menstrual Cycle
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Epilepsy
Drug Resistant Epilepsy
GLUT1DS1
Ketogenic Dieting
Menstrual Epilepsy
Keywords: ketogenic diet
ketonemia
menstrual cycle
Lead sponsor: University of Pavia
Sponsor class: OTHER
Collaborators: name: IRCCS ISTITUTO NEUROLOGICO CASIMIRO MONDINO
First posted: 2022-02-10
Enrollment: 15
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible participants will be female patients aged 13 years or older, with regular menstrual cycle, who have been undergoing a KDT for at least 3 months and thus previously diagnosed with Drug resistant epilepsy or GLUT1DS.

Brief summary: Ketogenic dietary therapies (KDTs) are well-established, safe, non-pharmacologic treatments used for children and adults with drug-resistant epilepsy and other neurological disorders. Ketone bodies levels undergo a significant inter-individual and intra-individual variability and can be affected by several factors. This evidence suggests the need for personalized monitoring for diet optimization, especially at the beginning of the treatment but during whole follow-up. Possible variations in glycemia and ketone bodies' blood level according to different phases of menstrual cycle have not been systematically assessed yet, but this time window deserves special attention because of hormonal and metabolic related changes. We present the methodological protocol for a longitudinal, multicentric study aimed at searching for subtle changes in ketone bodies blood level during menstrual cycle in epileptic female patients undergoing a stable ketogenic diet. The study will be divided into two phases. The first one will be purely observational, aiming at the assessment of ketonemia during menstrual cycle. Whether this finding will be confirmed, a second phase of ketogenic diet therapy adjustment will be scheduled.


Eligibility criteria: Inclusion Criteria:

* Patients with drug resistant epilepsy or GLUT1DS undergoing KD from at least 3 months before inclusion to the study
* Patients who had menarche at least 3 months before inclusion to the study
* Absence of recognized endocrinologic problems/ disease

Exclusion Criteria:

* Patients who experienced secondary amenorrhea
* Patients who have irregular menstrual cycle
* Pregnant patients

Primary outcomes:
measure: To measure serum ketone bodies level through different phases of menstrual cycle
timeFrame: 3 months
Secondary outcomes:
measure: Evaluation of the efficacy of an individualized intermittent adjustment of the dietary regimen
timeFrame: 3 months
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: University of Pavia
Study officials:
References:
Clinical trial NCT06945211: Task Oriented Mirror Therapy for Upper Limb Motor Function in Stroke Patient
Official title: Task Oriented Mirror Therapy for Upper Limb Motor Function in Stroke Patient
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke Patients
Keywords: Mirror Therapy
Stroke
Neurorehabilitation
Lead sponsor: Foundation University Islamabad
Sponsor class: OTHER
First posted: 2025-04-25
Enrollment: 36
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Stroke remains a major public health disease worldwide ,it usually associating with damage to the motor function and other functional disabilities. Persistent upper extremity dysfunction affects many post strokepatients and is strongly associated with decreased activities of daily living . Mirror therapy one of the rehabilitation that is beneficial for neuroplasticity .This therapy is used to improve motor function after stroke .

Detailed description: OBJECTIVES:

The objectives of this study are :

1. To imorove upper limb motor function and
2. To improve activities of daily lving .
3. To enhance motor skills.

HYPOTHESIS:

Alternate Hypothesis:

There will be statisticallly significant difference in high intensity task oriented mirror therapy and low intensity task oriented mirror therapy on upper limb motor function ,activities of daily living and enhancing motor skills in stroke patients (p\<0.05)

Null Hypothesis:

There will be no statisticallly significant difference in high intensity task oriented mirror therapy and low intensity task oriented mirror therapy on upper limb motor function

,activities of daily living and enhancing motor skills in stroke patients (p\>0.05)

RESEARCH DESIGN : Experimental study .Randomized control trail.

Eligibility criteria: Inclusion Criteria:

* Both genders.
* Age of patient 45 years and above
* Both ischemic and hemorrhagic stroke ( subacute and chronic stroke). Cognitive function relatively intact score \> 24 MoCA
* The patient can sit with / without support for more than 30 min

Exclusion Criteria:

* Subjects with visual impairments or unilateral neglect.
* having global aphasia.
* unstable medical conditions or comorbidities.
* score 3 and above on modified ashworth scale.
* patient with orthopedic condition or any fractures.

Primary outcomes:
measure: UPPER LIMB MOTOR FUNCTION
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Foundation University College of Physical Thrapy
Study officials:
References:
Clinical trial NCT02679911: Treatment of Onychomycosis With Loceryl (Amorolfine) Nail Lacquer 5% Versus Ciclopirox Nail Lacquer
Official title: Subject Adherence and Satisfaction for Treatment of Onychomycosis With Loceryl Nail Lacquer 5% Versus Ciclopirox Nail Lacquer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Foot Dermatoses
Keywords: Onychomycosis
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2016-02-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intra-individual study
Primary purpose: TREATMENT

Brief summary: The main objective of this study is to compare subject's compliance and satisfaction for two modes of treatment of toenails infection (Onychomycosis) with Loceryl Nail Lacquer (Loceryl NL) and Ciclopirox Nail Lacquer (Ciclopirox NL).

Detailed description: A total of 20 subjects are to be included in 1 site in Germany.

Methodology:

Subjects will receive the following treatments on the right or left toenails:

* Loceryl Nail Lacquer to be applied once weekly for 12 weeks on all affected toenails of one foot.
* Ciclopirox Nail Lacquer to be applied once daily for 12 weeks on all affected toenails of the opposite foot.

Eligibility criteria: Inclusion Criteria:

* Subject with clinically Distal and Lateral Subungual Onychomycosis (DLSO) due to dermatophytes and/or yeast (including Candida) on at least one toenail of each foot at screening visit,
* Subject with less than 80% of the nail surface area with disease involvement and without matrix involvement, no dermatophytoma, streaks (spikes) or subungual hyperkeratosis \> 2mm,
* Subjects with positive mycological results (direct microscopy and culture) for dermatophytes and/or yeasts (including Candida) at baseline,
* Subjects with same number of affected toenails on both feet or no more than one additional affected toenail on one of the feet,

Exclusion Criteria:

* Subject with a surgical, medical condition or clinically important abnormal physical findings, which, in the judgement of the investigator, might interfere with interpretation of the objectives of the study (i.e. lack of autonomy),
* Subjects with post-traumatic nail, lichen planus, eczema, psoriasis, or other abnormalities of the nail unit, which could affect/influence the subject's compliance of the investigational products, or mask the effects of treatment (cure),
* Subjects with known immunodeficiency, radiation therapy, immune suppressive drugs.

Primary outcomes:
measure: Percent of "in Label" Adherent Subjects
timeFrame: Week 12
Secondary outcomes:
measure: Percent of Subjects Satisfied to Very Satisfied With Each Study Treatment at Week 12
timeFrame: Week 12
Other outcomes:
Locations:
city: Tübingen
country: Germany
Study officials:
affiliation: Universitäts-Hautklinik
name: Prof. Schaller
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01481311: Detection of Patients With Abnormal Water Distribution Based on Bioelectrical Impedance Analysis (BIA)
Official title: Detection of Patients With Abnormal Water Distribution Based on Bioelectrical Impedance Analysis (BIA)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Diseases
Lead sponsor: Seca GmbH & Co. Kg.
Sponsor class: INDUSTRY
First posted: 2011-11-29
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Data of 50 patients suffering from kidney disease are planned to be collected.

Brief summary: The aim of this clinical investigation is to prove that the seca mbca detects dialysis patients with abnormal water distribution correctly. Abnormal high water distribution is defined as more than 2 liters of Total Body Water (TBW) above a normal value range. TBW and Extra Cellular Water (ECW) are calculated with prediction equations for healthy subjects generated in BCA-01. The results are compared with TBW and ECW ascertained by dilution methods as standard reference methods. The Bioelectrical Impedance Analysis (BIA) method should be evaluated to the accuracy of the absolute measurement of the volume state of dialysis patients (euvolaemic and hypervolaemic) based on a single measurement.


Eligibility criteria: Inclusion Criteria:

The study will cover 50 adults. Men and women in an age range of 18 to 65 years and a Body Mass Index (BMI) range of 18.5 to 35 kg/m2 should be equally distributed. Subjects have to be patients with chronic kidney failure taking dialysis treatment. 25 patients are taken before and another 25 patients after this treatment. Patients that are taken before dialysis treatment should have been dialysed two and not three days before.

Exclusion Criteria:

* amputation of limbs
* gastrointestinal tract illnesses that influence the absorption of substances that are needed for dialysis
* bed-ridden patients patients with clinical relevant hypervolaemia or hypovolaemia
* electrical implant as cardiac pacemaker
* insulin pumps
* pregnancy or breastfeeding period
* subjects who cannot provide an Informed Consent Form (ICF) by themselves
* subjects who might be dependent from the sponsor or the investigation site

Primary outcomes:
measure: Bioelectrical impedance (Resistance and Reactance) of 5 and 50 kHz for the right body side
timeFrame: about 2 minutes
Secondary outcomes:
measure: Bioelectrical impedance (Resistance and Reactance) of 1, 1.5, 2, 3, 7.5, 10, 15, 20, 30, 75, 100, 150, 200, 300, 500, 750 and 1,000 kHz
timeFrame: about 2 minutes
measure: TBW
timeFrame: within 4 hours
measure: ECW
timeFrame: within 4 hours
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité University Medicine Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Torsten Slowinski, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04769011: Motor Impairments in Children With Autism Spectrum Disorder: a Multimodal Approach
Official title: Motor Impairments in Children With Autism Spectrum Disorder: a Multimodal Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Attention Deficit Hyperactivity Disorder
Intellectual Disability
Lead sponsor: IRCCS Eugenio Medea
Sponsor class: OTHER
First posted: 2021-02-24
Enrollment: 106
Sex: ALL
Minimum age (years): 1
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The general goal of the present proposal, Progetto MOSAICO, is the identification of a multimodal panel of neuropsychological, kinematic, neurophysiological, and genetic markers associated with motor abnormalities present in ASD.


Eligibility criteria: Inclusion Criteria:

* having a clinical diagnosis of neurodevelopmental disorders (either ASD, ADHD, or intellectual disability) according to DSM-5 criteria;
* children with typical development are also recruited from the general population by local pediatricians or from kindergartens/schools sited near our institute

Exclusion Criteria:

* using any stimulant or non-stimulant medication affecting the central nervous system
* having an identified genetic disorder
* having vision or hearing problems
* suffering from chronic or acute medical illness.

Primary outcomes:
measure: Movement Assessment Battery for Children 2 (MABC2)
timeFrame: immediately after the intervention
measure: Developmental Coordination Disorder Questionnaire (DCDQ)
timeFrame: immediately after the intervention
measure: kinematic analysis of a reach-to-drop task
timeFrame: immediately after the intervention
measure: Magnetic Resonance (MRI)
timeFrame: immediately after the intervention
measure: Diffusion Tensor Imaging (DTI)
timeFrame: immediately after the intervention
measure: Exome sequencing
timeFrame: immediately after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Bosisio Parini
country: Italy
facility: IRCCS E. Medea
state: Lecco
Study officials:
References:
Clinical trial NCT01066611: Study to Investigate Effects of CAL-263 in Subjects With Allergic Rhinitis Exposed to Allergen in an Environmental Chamber
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Two-Period Crossover Study to Investigate the Safety of CAL-263 in Allergic Rhinitis Subjects and Effects on the Response to Environmental Chamber Allergen Challenge
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Allergic Rhinitis
Keywords: Allergic Rhinitis
Allergy
Phosphatidylinositol 3-kinase
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2010-02-10
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety and effect of CAL-263 in subjects with allergic rhinitis.

Detailed description: A Phase I, randomized, double-blind crossover study of CAL-263, an oral inhibitor of PI3K delta, in patients with allergic rhinitis.

Eligibility criteria: Inclusion Criteria:

1. Age \>18 and \<55 years
2. Has a history of seasonal allergic rhinitis for at least 2 years
3. Has sensitivity to grass pollen demonstrated by a positive response to skin prick testing
4. Has a positive Radio Allergen Sorbent Test (class 2 or greater) for grass pollen during the previous 12 months or at screening
5. Is otherwise healthy
6. Is able to provide written informed consent

Exclusion Criteria:

1. Is a female of childbearing
2. History of chronic nasal or upper respiratory tract symptoms or disorders other than allergic rhinitis
3. History of nonallergic rhinitis, chronic sinusitis or severe asthma
4. Has a nasal condition likely to affect the outcome of the study
5. Is currently taking regular medication, whether prescribed or not, including corticosteroids, vitamins, macrolides, anti-fungal agents and herbal remedies
6. Has taken a prohibited medication within the specified interval prior to Visit 1

Primary outcomes:
measure: Evaluate the safety of CAL-263 in allergic rhinitis subjects
timeFrame: 46 days
Secondary outcomes:
measure: Determine the efficacy of CAL-263 on total nasal symptom scores following an allergen challenge in allergic rhinitis subjects
timeFrame: 7 days
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Vienna Challenge Chamber
Study officials:
affiliation: Vienna Challenge Chamber
name: Friedrich Horak, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06616311: Efficacy of Radiofrequency Micro Needling for the Treatment of Melasma in Skin of Color.
Official title: A Prospective Study of the Efficacy of Radiofrequency Micro Needling for the Treatment of Melasma in Skin of Color.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Melasma
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: Benev Company, Inc.
First posted: 2024-09-27
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Radiofrequency microneedling (RFMN) as a treatment for melasma
Primary purpose: TREATMENT

Brief summary: The objective of this study is to test the effectiveness of radiofrequency microneedling (RFMN) as a treatment for melasma. The Investigator hypothesize that RFMN will be an effective treatment for melasma in skin of color patients.

Detailed description: The target population is skin of color patients with melasma. Patients will receive 3 consecutive RFMN treatments over a period of three months. Baseline melasma severity will be measured by the modified Melasma Area and Severity Index (mMASI) score. Endpoints will be mMASI scores at 1 and 3 months post-procedure. Patient reported outcomes will be measured using the melasma quality of life (MelasQOL) validated patient questionnaire at screening and at both follow up visits. The long-term goal of future studies would be to provide melasma patients, particularly those with skin of color, with improved therapeutic options for the treatment of their melasma, as compared to current treatment options.

Eligibility criteria: Inclusion Criteria:

* Males or females, at least 18 years of age
* Fitzpatrick skin types IV-VI
* Clinically diagnosed melasma
* No topicals (retinol, vitamin C serum, etc) for 6 weeks before Visit 1 (with exception of sunscreen)

Exclusion Criteria:

* is currently pregnant or planning to conceive during the study period
* is using topical or oral therapy or other treatment for melasma

Primary outcomes:
measure: Treatment efficacy as determined by change in mMASI scoring of melasma severity post-treatment.
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
References:
Clinical trial NCT03578211: Impact of Decision Aids on Bariatric Surgery Choice
Official title: Impact of Decision Aids on Bariatric Surgery Choice: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Morbid
Lead sponsor: Taipei Medical University Shuang Ho Hospital
Sponsor class: OTHER
First posted: 2018-07-06
Enrollment: 140
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Sleeve gastrectomy, Roux-en-Y gastric bypass, laparoscopic gastric banding, and bioenteric intragastric balloon insertion are common types of bariatric surgeries. These treatment strategies have diverted outcomes in body weight loss, metabolic diseases control, surgical complications, and life quality improvement. Thus, shared decision making (SDM) is necessary to aid patients to choose an appropriate treatment that suits thier needs. Investigators have developed a decision aids (DAs) and plan to conduct a randomized controlled trial (RCT) to evaluate its impact on obese patients. The measurements include a battery of interview-based questionnaires and evaluations of decision regret and knowledge improvement. Investigators expect the DAs would benefit the intervention group in the aspects of knowledge, communication and anxiety status during and after their treatment sessions.


Eligibility criteria: Inclusion Criteria:

1. Body mass index (BMI) ≧ 32 kg / m2 with obesity-related comorbidity
2. Body mass index (BMI) ≧ 37 kg / m2

Exclusion Criteria:

1. Endocrine system abnormalities in patients
2. Drug abuse or mental illness
3. Major organ dysfunction and can accept surgery
4. Patients cannot understand Chinese
5. Age less than 20 years old or more than 70 years old

Primary outcomes:
measure: Decisional conflict
timeFrame: One week after intervention
Secondary outcomes:
measure: Decision regret
timeFrame: 3 month after bariatric surgery
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Taipei Medical University-Shuang Ho Hospital
state: Zhonghe District
Study officials:
affiliation: Metabolic and Weight Management Center, Shuang-Ho Hospital
name: Yen-Hao Su, MD
role: PRINCIPAL_INVESTIGATOR
References: