louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01943968: Lysyl Oxidase, Semaphorin 7a and Semaphorin 3a in Patients With Systemic Sclerosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Systemic Sclerosis
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2013-09-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of our study is to find a biomarker for fibrosis or vasculopathy in systemic sclerosis. We will evaluate a possible correlation between semaphorin 7a, semaphorin 3a and lysyl oxidase and fibrosis (lung and skin) or vasculopathy in patients with systemic sclerosis. The results obtained may help us diagnose these complications of systemic sclerosis and hopefully even monitor patient treatment.


Eligibility criteria: Inclusion Criteria:

* Systemic Sclerosis Patients
* Written consent to participation in study

Exclusion Criteria:

* Serious active medical condition
* Other autoimmune rheumatic disease
* Current or past allergic/inflammatory reaction
* Liver disease
* Pregnant or breastfeeding
* Illegal drug or alcohol abuse

Primary outcomes:
measure: Fibrin Enzyme Levels in Blood
timeFrame: Six months
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Bnai Zion Medical Center
Study officials:
affiliation: Bnai Zion Medical Center
name: Doron River, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00832468: The Complementary Effect of Ear Acupressure on Older Patients With Chronic Insomnia
Official title: The Complementary Effect of Ear Acupressure on Older Patients With Chronic Insomnia and Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Insomnia
Keywords: insomnia
ear acupressure
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
First posted: 2009-01-30
Enrollment: 72
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Ear acupressure is commonly applied to treat insomnia in Oriental clinical practice but lacking the evidence of the randomized controlled trial (RCT)of ear acupressure on insomnia. In this study, a RCT is conducted to investigate the complementary effect of ear acupressure on chronic insomnia in old adults.

Detailed description: Even though there have been many advances in the pharmacological treatment of insomnia, many patients with insomnia visit complementary and alternative medicine (CAM) specialists for help due to fear of the side effects of long-term treatment with hypnotics. Acupuncture is commonly used to treat insomnia in the field of CAM. Among the different methods of acupuncture, it has been noted that ear acupressure (placing magnetic pellets on the auricular points), which has the advantage of being non-invasive and easily carried out, shows possible effects whereby there is improvement in the sleep quality of old adults. However, it is lacking of the evidence of the randomized controlled trial (RCT) of ear acupressure on insomnia.

Insomnia is related to homeostatic dysregulation of autonomic nervous system (ANS). Ear acupuncture and its related techniques are believed to act through the reticular formation and the ANS may thus result in an amelioration of illness.

In this study, a RCT is conducted to investigate the complementary effect of ear acupressure on chronic insomnia in old adults.Besides, the changes of ANS function (measured by heart rate variability) are recorded to evaluate the role of ANS in the treatment of insomnia.

Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of primary insomnia

Exclusion Criteria:

* diabetic neuropathy
* cardiac arrythmia
* liver disease (ALT\> 120 U/L)
* renal disease (Cr\> 2 mg/dl)
* severe depression

Primary outcomes:
measure: polysomnography
timeFrame: 4 weeks
Secondary outcomes:
measure: Pittsburgh sleep quality index, Heart rate variability, SF-36
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: Institute of Traditional Medicine, National Yang-Ming University and Taipei Veterans General Hospital, Taiwan
name: Yen-ying Kung, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01703468: Crossover Bioequivalence Study of Oxcarbazepine 600 mg Suspension Under Fed Conditions
Official title: A Single Dose, Two-Period, Two-Treatment, Two-Sequence Crossover Bioequivalence Study of Oxcarbazepine 600 mg Suspension Under Fed Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Seizures
Lead sponsor: West-Ward Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2012-10-10
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study was to prove the bioequivalence of Roxane Laboratories' Oxcarbazepine Suspension 600 mg under fed conditions


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to oxcarbazepine or any comparable or similar product.

Primary outcomes:
measure: bioequivalence determined by statistical comparison Cmax
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Worldwide Clinical Trials Drug Development Solutions (formerly CEDRA Clinical Research)
state: Texas
Study officials:
affiliation: Worldwide Clinical Trials Drug Development Solutions (formerly CEDRA Clinical Research)
name: Cynthia Zamora, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03195868: Photobiomodulation Therapy and Nerve Density for Patients With Diabetic or Chemotherapy-associated Neuropathy
Official title: A Comparative Analysis of Changes in Peripheral Nerve Density and Structure Following Photobiomodulation Therapy Using the REALief Therapy System for Patients With Diabetic or Chemotherapy-associated Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuropathy
Neuropathy, Diabetic
Neuropathy Toxic
Keywords: chemotherapy
chemo-induced
CIPN
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2017-06-22
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group, prospective cohort
Primary purpose: TREATMENT

Brief summary: This study seeks to determine if photobiomodulation (PBM, or low level laser light) affects the growth and distribution of nerves int he skin. Our previous study demonstrated that the treatment we use here was effective at reducing the symptoms of neuropathy (as measured by the modified total neuropathy score) in patients who had been treated with chemotherapy. The current effort is designed to repeat this confirm this observation using a more extensive battery of survey as well as to begin to elucidate the mechanism through which photobiomodulaiton produces the effect. WE will also be attempting to determine if diabetic patients differ in terms of response from chemotherapy patients

Detailed description: Consenting patients with self-reported neuropathy following either diabetes or administration of chemotherapy, will undergo sensory testing and skin biopsies of the the foot and leg prior to initiating treatment. They will undergo PBM 3 times weekly for 6 weeks with with a follow-up biopsy performed at the conclusion of therapy and sensory testing throughout. Patients will have one remote evaluation at 26 weeks to determine whether the effect, if any extinguishes.

Eligibility criteria: Inclusion Criteria: self reported neuropathy following exposure to diabetes or chemotherapy

* willingness to undergo biopsies and 6 weeks of therapy

Exclusion Criteria:

* pregnancy
* active cancer treatment

Primary outcomes:
measure: change in epidermal nerve density and/or distribution
timeFrame: Change at Baseline 6 weeks, 26 weeks
measure: total nerve fiber density,
timeFrame: Change at Baseline 6 weeks, 26 weeks
Secondary outcomes:
measure: Brief Pain index
timeFrame: Change at Baseline 6 weeks, 26 weeks
measure: NTSS- Nueropathy Total Symptom Score
timeFrame: Change at Baseline 6 weeks, 26 weeks
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
References:
citation: Argenta PA, Ballman KV, Geller MA, Carson LF, Ghebre R, Mullany SA, Teoh DG, Winterhoff BJ, Rivard CL, Erickson BK. The effect of photobiomodulation on chemotherapy-induced peripheral neuropathy: A randomized, sham-controlled clinical trial. Gynecol Oncol. 2017 Jan;144(1):159-166. doi: 10.1016/j.ygyno.2016.11.013. Epub 2016 Nov 22.
Clinical trial NCT05335746: Ocular Changes in Vitiligo Patients on Therapy
Official title: Chorioretinal Changes in Vitiligo Patients on Therapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Vitiligo
Chorioretinopathy
Chorioretinitis
Keywords: Vitiligo
Chorioretinitis
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2022-04-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Dermatology and ophthalmology clinics at banha university.

Brief summary: Vitiligo patients on systemic and local therapy may have some ocular adverse effects associated with the disease and its therapy.

Detailed description: Chorioretinal changes associated with vitiligo therapy could address patients visual acuity and life style. Early detection of these changes can help these patients to evade such adverse effects.

Eligibility criteria: Inclusion Criteria:

* vitiligo patients on systemic and local therapy that regularly visit dermatology clinic at banha university.
* normal subjects seeking regular ophthalmic examination at ophthalmology clinic at banha university.

Exclusion Criteria:

* patients with known chronic retinal diseases that may alter OCT-A parameters as age related macular degeneration and diabetic retinopathies.
* patients that refuse to participate in this study.

Primary outcomes:
measure: Percentage of vessel density (VD) in superficial and deep retinal layer.
timeFrame: Immediately after OCT-A for each eye and at one month of follow-up.
Secondary outcomes:
measure: Foveal avascular zone (FAZ) in millimeter (mm).
timeFrame: Immediately after OCT-A for each eye and at one month of follow-up.
Other outcomes:
measure: Changes in visual acuity
timeFrame: Immediately after OCT-A for each eye and at one month of follow-up.
measure: Changes in choroidal thickness
timeFrame: Immediately after OCT-A for each eye and at one month of follow-up.
Locations:
city: Banhā
country: Egypt
facility: Benha University
state: QA
Study officials:
affiliation: Benha University
name: Amal A Yousif, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06868446: Feasibility of a Digital Therapeutic for Adults with Posttraumatic Stress Disorder (PTSD)
Official title: Dosage, Feasibility, Acceptability and Usability of OTX-601
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: PTSD
Post Traumatic Stress Disorder
Keywords: PTSD
Lead sponsor: Oui Therapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Mental Health (NIMH)
name: Florida State University
First posted: 2025-03-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DEVICE_FEASIBILITY

Brief summary: This study is exploring the efficacy of a digital therapeutic app in reducing symptoms of posttraumatic stress disorder (PTSD) in adults.

Detailed description: The purpose of this study is to conduct a randomized controlled trial to evaluate the usability and feasibility as well as the safety and effectiveness of OTX-601 (version 1) + TAU compared to OTX-601 (version 2) + TAU in reducing PTSD symptoms from baseline to 7 weeks.

Eligibility criteria: Inclusion Criteria:

The primary inclusion criteria for this study will be a PTSD diagnosis, ASI-3 scores above 24, PCL scores above 30, and understanding and speaking English. The only software/hardware requirements are that participants have access to a smartphone that is connected to the internet.

Exclusion Criteria:

1) Score of 24 or lower on the ASI-3, 2) score of 30 and below on the PCL-5, 3) no PTSD diagnosis, 4) active psychosis, 5) Acutely intoxication during study baseline, 6) enrolled in another treatment research study, 8) If applicable, medical illness that would prevent the completion of interoceptive exposure exercises.

Primary outcomes:
measure: PTSD Checklist for DSM-V (PCL-5)
timeFrame: Baseline, week 1, week 2, week 3, and week 7
measure: System Usability Scale (SUS)
timeFrame: week 1, week 2, and week 3
Secondary outcomes:
measure: Anxiety Sensitivity Index 3 (ASI-3)
timeFrame: Baseline, week 1, week 2, week 3 and week 7
Other outcomes:
Locations:
Study officials:
affiliation: Oui Therapeutics, Inc.
name: Patricia Simon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04056546: Interest of Rapid Typing in Adenovirus Infections.
Official title: Interest of Rapid Typing in Adenovirus Infections: Sensitivity and Specificity, Study of the Association Clinical Characteristics and Viral Type.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adenovirus
Adenovirus Disease
Genotyping
Keywords: Real-time Polymerase-Chain Reaction
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2019-08-14
Enrollment: 296
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Therefore inclusion in this study of any patient having at least a viral load greater than or equal to 10 \^ 4 copies / mL (blood and body fluids) or copies / gram of stool or copies / μg of DNA (biopsies) for the duration study.

Brief summary: Proposal of a "rapid typing" technique by a new real-time PCR method, simpler, faster and cheaper than nucleotide sequencing (reference method) for rapid typing in Adenovirus infections.

Detailed description: Adenoviruses cause many infections, mainly respiratory and gastroenteric, in pediatrics.

They also behave as opportunistic agents in 10% of hematopoietic stem cell recipients. In these immunocompromised persons, these infections are all the more frequent as the graft is of placental origin and the recipient a child (20%). They are then willingly disseminated and potentially deadly; their treatment is based on cidofovir, a viral agent that is very sensitive to handling.

Adenoviruses, which have a high genetic diversity, are classified into 7 types. According to some observations, still limited, some types of Adenovirus would show a higher pathogenicity (types C and A). Thus, viral typing may be prognostic for immunocompromised patients, justifying the initiation of an earlier specific treatment when identifying certain more pathogenic viral types, in addition to measuring the viral load, already performed by quantitative PCR.

For this purpose, this study proposes a "fast typing" technique by new real-time PCR method, simpler, faster and cheaper than nucleotide sequencing, reference method.

Eligibility criteria: Inclusion criteria:

- viral load greater than or equal to 10 \^ 4 copies / mL (blood and body fluids) or copies / gram of stool or copies / μg of DNA (biopsies).

Exclusion Criteria:

* Samples identified as positive in Adenovirus, not re-analyzable (insufficient sample quantity, alteration during thawing).

Primary outcomes:
measure: Type viral characterization (scale A to G)
timeFrame: At the screening
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Bordeaux
name: Marie-Edith LAFON, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00736346: Treatment of Panic Disorder Among Individuals Consulting Emergency Departments for Non Cardiac Chest Pain
Official title: Efficacy of Three Treatment Modalities for Panic Disorder Among Individuals Consulting Emergency Departments for Non Cardiac Chest Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Panic Disorder
Anxiety Disorder
Mental Disorder
Keywords: Panic Disorder
anxiety
chest pain
emergency department
cognitive-behavioral treatment
Lead sponsor: Université du Québec a Montréal
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2008-08-15
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the impact of three different treatment modalities on panic symptoms, quality of life and use of health services among individuals consulting an emergency department for non cardiac chest pain and having Panic Disorder.


Eligibility criteria: Inclusion Criteria:

* Aged 18 and over
* Mastered oral and written French
* Consulted an emergency department for chest pain with very low risk of coronary disease (normal ECG and blood tests)
* Met criteria for Panic Disorder

Exclusion Criteria:

* Chest pain with an obvious medical origin (obvious trauma or abnormal pulmonary x-rays)
* Had received cognitive-behavior therapy for Panic Disorder in the last six months
* Cognitive impairment preventing the completion of psychological assessment
* Past or present psychotic episode, Bipolar Disorder, or organic mental disorder
* Current Abuse or Dependence Disorder
* If another Mental Disorder is present, its severity was equal or inferior to the severity of Panic Disorder
* Current medical condition preventing the participant from receiving pharmacological of cognitive-behavior treatment

Primary outcomes:
measure: Panic Disorder diagnosis
timeFrame: Pre and posttreatment, and 3, 6 and 12 months after treament
Secondary outcomes:
measure: Panic symptomatology, psychological distress, quality of life, and use of health services
timeFrame: Pre and posttreatment, and 3, 6 and 12 months after treatment
Other outcomes:
Locations:
city: Lévis
country: Canada
facility: Hôtel-Dieu de Lévis
state: Quebec
city: Montréal
country: Canada
facility: Institut de Cardiologie de Montréal (Montreal Heart Institute)
state: Quebec
city: Montréal
country: Canada
facility: Hôpital du Sacré-Coeur de Montréal
state: Quebec
Study officials:
affiliation: Université du Québec a Montréal
name: André Marchand, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Foldes-Busque G, Hamel S, Belleville G, Fleet R, Poitras J, Chauny JM, Vadeboncoeur A, Lavoie KL, Marchand A. Factors associated with pain level in non-cardiac chest pain patients with comorbid panic disorder. Biopsychosoc Med. 2016 Oct 18;10:30. doi: 10.1186/s13030-016-0081-5. eCollection 2016.
Clinical trial NCT01063946: A Study to Investigate the Disposition of Radio-labeled AVE8062 Compound Administered as a 30-minute IV Infusion to Patients With Advanced Solid Tumor
Official title: A Phase I, Open Label Study Investigating the Disposition of 25 mg/m² [14C]-AVE8062 (1.85 MBq, 50 µCi) Administered at Cycle 1 as a 30-minute Intravenous Infusion to Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasms, Malignant
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2010-02-05
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Primary Objectives:

* To determine the excretion balance and systemic exposure of radioactivity after intravenous infusion of \[14C\]-AVE8062 to humans
* To determine the pharmacokinetics of AVE8062 and RPR258063 and their contribution to overall exposure
* To collect samples to determine the metabolic pathways of AVE8062 and identify the chemical structures of the main metabolites

Secondary Objective:

* To assess the safety profile of the drug

Detailed description: The duration of the study for each patient will include approximately 4 weeks of a screening phase prior to first infusion of study drug, 21-day study treatment cycles and end of treatment visit. The patient can continue treatment until disease progression, unacceptable toxicity, or the patient's refusal of further treatment.

Eligibility criteria: Inclusion criteria:

* Patients with advanced neoplastic disease that has become refractory to conventional treatment or for which no standard therapy exists.
* Age = or \> 18 years
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
* Adequate hematological, hepatic and renal functions

Exclusion criteria:

* Poor metabolizers for CYP2C19, CYP2C9, CYP2D6 and polymorphic UGTs will be excluded from the study

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Percentage of radioactive dose excreted in urine, feces and expired air
timeFrame: 3 weeks (end of cycle 1) or 30 days after the first dose
measure: Concentration-time profiles and pharmacokinetic (PK) parameters of total radioactivity in whole blood and plasma; blood over plasma concentration ratios; Concentration-time profile and PK parameters of AVE8062 and RPR258063 in plasma
timeFrame: 3 weeks (end of cycle 1) or 30 days after the first dose
Secondary outcomes:
measure: Safety assessment based on Adverse events reporting, laboratory tests according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTC) v3.0 grade scaling
timeFrame: 3 weeks (end of cycle 1) or 30 days after the first dose
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: