louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04631107: AD109 Dose Finding in Mild to Moderate OSA
Official title: Phase 2 Randomized Double-Blind Placebo-Controlled 3-Period Single-Dose Crossover Study to Evaluate the Safety and Efficacy of Two Doses of AD-109 in Mild to Moderate Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obstructive Sleep Apnea
Lead sponsor: Apnimed
Sponsor class: INDUSTRY
First posted: 2020-11-17
Enrollment: 32
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a randomized, 3-period, placebo-controlled, crossover, phase 2 clinical study to examine the efficacy and safety of 2 doses of AD109 vs placebo in patients with mild obstructive sleep apnea.

Detailed description: Participants underwent initial pre-screening to determine potential study eligibility. Participants selected for further screening had either a previous history of OSA of a severity consistent with enrollment criteria or were at high risk (e.g. as assessed by STOP-Bang Questionnaire score). Only participants who met all non polysomnography (PSG) enrollment criteria at Visit 1 were eligible for a screening PSG.

Eligibility criteria: Inclusion Criteria:

* AHI between 5 and 20 events/h
* PGI-S equal to or higher than 1, or one or more of the following symptoms:

  * Snoring or nightime gasping/choking
  * Daytime sleepiness, fatigue or decreased concentration
  * Nonrefreshing sleep, sleep fragmentation (including from nocturia), or morning headache
  * Irritability, decreased mood or libido

Exclusion Criteria:

* History of narcolepsy.
* Clinically significant craniofacial malformation.
* Clinically significant cardiac disease (e.g. rhythm disturbances, coronary artery disease or heart failure or hypertension requiring more than 2 medications for control).
* CPAP should not be used for at least 2 weeks prior to the study
* History of using oral or nasal devices for the treatment of OSA may enroll as long as the devices are not used during participation in the study.

Primary outcomes:
measure: Change in Hypoxic Burden (HB) Log Transformed - Log10HB[(%*Min)/h]
timeFrame: 1 night (8 hours)
measure: Change in Hypoxic Burden (HB) Raw Values - HB[(%*Min)/h]
timeFrame: 1 night (8 hours)
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Pacific Research Network
state: California
city: Atlanta
country: United States
facility: NeuroTrial Research
state: Georgia
city: Philadelphia
country: United States
facility: Brian Abaluck, LLC
state: Pennsylvania
Study officials:
affiliation: Apnimed
name: Ron Farkas, MD
role: STUDY_DIRECTOR
References:
citation: Rosenberg R, Abaluck B, Thein S. Combination of atomoxetine with the novel antimuscarinic aroxybutynin improves mild to moderate OSA. J Clin Sleep Med. 2022 Dec 1;18(12):2837-2844. doi: 10.5664/jcsm.10250.
Clinical trial NCT05361707: Evaluating the Effects of Tasimelteon in Individuals With Autism Spectrum Disorder (ASD) and Sleep Disturbances
Official title: A Study to Evaluate the Efficacy and Safety of Tasimelteon in Treating Sleep Disturbances in Individuals With Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Autism Spectrum Disorder
Sleep Disorder
Neurological Disorder
Sleep Disturbance
Lead sponsor: Vanda Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2022-05-05
Enrollment: 100
Sex: ALL
Minimum age (years): 2
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a multicenter, open-label study to evaluate the efficacy and safety of a daily single oral dose of tasimelteon in treating sleep disturbances in pediatric and adult participants with ASD.


Eligibility criteria: Inclusion Criteria:

* Ability and acceptance to provide written informed consent of the participant or legal guardian (and assent as required).
* A confirmed clinical diagnosis of Autism Spectrum Disorder (ASD) and a recent history of sleep disturbances.
* The sleep disturbance must not be a result of another diagnosable disorder or medication.
* Male or female between 2 and 65 years of age, inclusive.
* Willing and able to comply with study requirements and restrictions.

Exclusion Criteria:

* Inability to dose daily with tasimelteon or previous intolerance to tasimelteon.
* Indication of impaired liver function.
* Evidence of increased risk of self-harm.
* Pregnant or lactating females.
* A positive test for drugs of abuse.
* Other diagnosable causes of sleep disorders or use of medications that may cause sedation or stimulation.

Primary outcomes:
measure: Change in sleep time over the treatment period, as measured by sleep diary.
timeFrame: 12 weeks
Secondary outcomes:
measure: Improvement in objective sleep-wake parameters such as severity of condition, as measured by administered questionnaires.
timeFrame: 12 weeks
measure: Improvement in objective behavioral parameters such as the participant's overall behavior, as measured by sleep diary in the Patient Global Impression of Severity Behavior Questionnaire (PGI-S Behavior).
timeFrame: 12 weeks
measure: Assessment of safety and tolerability of daily single dose of tasimelteon, as measured by spontaneous reporting of adverse events (AEs).
timeFrame: 12 weeks
Other outcomes:
Locations:
city: San Jose
country: United States
facility: Vanda Investigational Site
state: California
city: San Leandro
country: United States
facility: Vanda Investigational Site
state: California
city: Santa Monica
country: United States
facility: Vanda Investigational Site
state: California
city: Boulder
country: United States
facility: Vanda Investigational Site
state: Colorado
city: Staten Island
country: United States
facility: Vanda Investigational Site
state: New York
Study officials:
References:
Clinical trial NCT02230007: Contribution of the MEOPA in the Physiotherapy Care of Painful Articular Steepness Among Elderly
Official title: Contribution of the MEOPA in the Physiotherapy Care of Painful Articular Steepness Among Elderly
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pain Management and Care
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2014-09-03
Enrollment: 64
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The MEOPA is used to obtain an analgesia of the short-term painful acts. To the population of elderly patients, the therapeutic resources to control the passing pain require in their manipulation a certain caution and are not divested of side effects badly tolerated at this age. An alternative in the opioid presents all its interest. The MEOPA is here an alternative of choice in the care of these pains, in particular in case of pre-existent cognitive achievement, of polypathologies or of polymédication.

The gas MEOPA administered to the mask could thus be an effective additive in the physiotherapy treatment of the elderly person.

The main objective is to Assess the efficacy , in terms of recovery of the hip and knee joint articular amplitude, of 3 sessions of reeducation using MEOPA versus standard reeducation within a population of elderly patients presenting a pain during the physiotherapy treatment.


Eligibility criteria: Inclusion Criteria:

* Male or female aged 65 years old or more
* Patients having a prescription for physiotherapy
* Absence of contraindication to MEOPA
* Patients whose initial assessment show a passive articular deficit of at least a joint of hip or the knee and whose painful assessment is ≥ 5 or ≥ 2 during mobilisation on the validated scale Algoplus
* Patients whose reeducation project established by the physiotherapist
* Patients having agreed to participate in the study and having signed the consent
* Subjects affiliated to the social security system

Exclusion Criteria:

* Patient requiring a ventilation in pure oxygen
* Patient with a consciousness deterioration preventing his cooperation
* Care under MEOPA during the period of the protocol and during the month which precedes
* Increase of the dosage of morphine of less than 48 hours Patient under guardianship

Primary outcomes:
measure: % of recovery of the hip and knee joint articular amplitude
timeFrame: 5 days
Secondary outcomes:
measure: Measure of the pain
timeFrame: 5 days
measure: Patients'satisfaction
timeFrame: End of the period of care (up to 5 days)
measure: Physiotherapists'satisfaction
timeFrame: End of all the period of care (up to 5 days)
Other outcomes:
Locations:
city: Nice
country: France
facility: Pôle de Gérontologie Hôpital de Cimiez CHU de Nice
city: Nice
country: France
facility: CHU de Nice
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: Véronique Mailland, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04092907: A Study Evaluating the Efficacy and Safety on Moderate to Severe Dry Eye
Official title: A Phase 2, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Efficacy and Safety of HBM9036 Ophthalmic Solution Versus Placebo in Subjects With Moderate to Severe Dry Eye
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dry Eye
Lead sponsor: Harbour BioMed (Guangzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2019-09-17
Enrollment: 100
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: The purpose of this study is to compare the efficacy and safety of HBM9036 Ophthalmic Solution versus placebo in the treatment of dry eye

Detailed description: HBM9036 is a molecularly engineered tumor necrosis factor receptor 1 (TNFR1) fragment.

A total of 100 subjects are expected to be randomized. Subjects will be randomized 1:1 at Visit 2 to HBM9036 Ophthalmic Solution or placebo group, bilaterally BID for eight weeks. The primary efficacy endpoint is sign changes from baseline in change from pre- to post-CAE inferior corneal staining score (ICSS) of the study eye evaluated at week 8 .

Eligibility criteria: Inclusion Criteria

1. Have a history of use eye drops for dry eye symptoms within 6 months of Visit 1 or desire to use eye drops;
2. Have in the study eye a Schirmer's Test score of ≤ 10 mm and ≥ 1 mm at Visits 1 and 2;
3. Be willing and can adjust current treatment for dry eye according to the protocol, judged by the Investigator;
4. Must be willing to complete all study assessments required by the protocol.

Exclusion Criteria:

1. Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1;
2. Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months, or had femtosecond small incision lenticule extraction (SMILE) within the last 12 months, or had phacoemulsification within the last 3 months, or had dry eye or aggravation of dry eye caused by other ocular operations has not been stable;
3. Have used ophthalmic cyclosporine A, tacrolimus or Xiidra® within 60 days prior to Visit 1;

Primary outcomes:
measure: Inferior Corneal Staining (ICS) Score
timeFrame: 8 weeks
Secondary outcomes:
measure: Ocular Discomfort Score
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Qingdao
country: China
facility: Qingdao Eye Hospital
state: Shandong
Study officials:
affiliation: QINGDAO EYE HOSPITAL
name: Lixin XIE, Academician
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dong Y, Wang S, Cong L, Zhang T, Cheng J, Yang N, Qu X, Li D, Zhou X, Wang H, Lee M, Wang M, Chen S, Ousler GW, Chen X, Xie L. TNF-alpha inhibitor tanfanercept (HBM9036) improves signs and symptoms of dry eye in a phase 2 trial in the controlled adverse environment in China. Int Ophthalmol. 2022 Aug;42(8):2459-2472. doi: 10.1007/s10792-022-02245-1. Epub 2022 Feb 22.
Clinical trial NCT01754207: Evaluation of the 755nm Alexandrite Laser for the Treatment of Tattoos
Official title: Evaluation of the 755nm Alexandrite Laser for the Treatment of Tattoos
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tattoos
Lead sponsor: Cynosure, Inc.
Sponsor class: INDUSTRY
First posted: 2012-12-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to collect further data on the safety and efficacy of removing unwanted non cosmetic tattoos (including recalcitrant) using the 755nm Alexandrite laser.


Eligibility criteria: Inclusion Criteria:

1. Is a healthy male or female between 18 and 85 years old.
2. Has unwanted non-cosmetic tattoo(s) and wishes to undergo laser treatments to remove them.
3. Is willing to consent to participate in the study.
4. Is willing to comply with all requirements of the study including being photographed, following post treatment care and attending all treatment and follow up visits

Exclusion Criteria:

1. Is hypersensitive to light exposure.
2. Has active localized or systemic infection.
3. Is taking medication(s) for which sunlight is a contraindication.
4. Has a history of squamous cell carcinoma or melanoma.
5. Has a history of keloid scarring.
6. Has used oral isotretinoin (Accutane®) within 12 months of initial treatment or plans on using during the course of the study. Note: Skin must regain its normal degree of moisture prior to treatment.
7. Has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications.
8. Is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period.
9. Is allergic to lidocaine, tetracaine or Xylocaine with epinephrine.
10. Has any other reason determined by the physician to be ineligible to participate in the study.

Primary outcomes:
measure: Tattoo Clearance Using Photographic Evaluation
timeFrame: up to 3 months post last treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Chestnut Hill
country: United States
facility: Skin Care Physicians
state: Massachusetts
Study officials:
affiliation: Cynosure, Inc.
name: Patricia Krantz
role: STUDY_DIRECTOR
References:
Clinical trial NCT02857907: Anti-thymocyte Globulin-induced Immune Senescence
Official title: Anti-thymocyte Globulin-induced Immune Senescence
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Disorder Related to Renal Transplantation
Keywords: Kidney transplantation
Immunosuppressive treatment
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2016-08-05
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients awaiting kidney transplantation, followed at Besançon University Hospital and who have given their consent for the conservation of cells for a study of the immune system in kidney transplant patients.

Brief summary: The aim of the study is to investigate the impact of Anti-Thymocyte Globulin (ATG) on immune senescence. Markers of immune senescence expression is assessed in a prospective cohort of renal transplant recipients the day of transplantation and one year after renal transplantation.

Detailed description: The anti-thymocyte globulin (ATG) are used in the prevention and treatment of acute rejection in organ transplantation. They are at the origin of a brutal CD4 lymphocyte depletion followed by a gradual recovery of the lymphocyte pool. Nevertheless, CD4 lymphopenia can persist in some patients.

SIGAL study aims to characterize the immune responses of lymphopenic patients (after administration of ATG) in order to identify possible similarities with immunosenescence.The immunosenescence is a complex and profound remodeling of the immune system during life. It is mainly due to thymic involution and repeated antigenic stimulation.

Eligibility criteria: Inclusion Criteria:

* Patient able to understand the reason of the study
* Signature of informed consent
* Patient who are waiting renal transplant

Exclusion Criteria:

* Inability to understand the reasons for the study; psychiatric disorders
* Any history in the last 2 years of immunosuppressive therapy (except steroids)
* History of cancer (except skin cancer) or treated hematological malignancy

Primary outcomes:
measure: Percentage of senescent lymphocytes
timeFrame: One year after kidney transplantation
Secondary outcomes:
Other outcomes:
Locations:
city: Besancon
country: France
facility: University Hospital
Study officials:
affiliation: CHU Besançon
name: Jamal Bamoulid, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06486207: Effects of Kendall Exercise VS Gong's Mobilization on Pain, Range of Motion, Function, and Strength in Cases With UCS
Official title: Effects of Kendall Exercise VS Gong's Mobilization on Pain, Range of Motion, Function, and Strength in Cases With Upper Cross Syndrome
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Syndrome, Down
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 44
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The effectiveness of kendall exercise vs. gong's mobilization for alleviating pain with improvment in range of motion, function and strength in cases with upper cross syndrome, assessed by dividing 44 patinets in two groups as Group A (n=22) was treated with Kendall exercises and Group B (n=22) managed by Gong's mobilization. VAS, NDI, SPADI, Goniometer and Dyanometer were used for assessing primary and secondary outcomes in patients.


Eligibility criteria: Inclusion Criteria:

* Adults aged 45-65 years old
* Both genders
* Diagnosed with upper cross syndrome (UCS)
* Rounded shoulders
* Forward head posture
* Tightness in the pectoralis major and minor muscles 7. Weakness in the lower trapezius and rhomboid muscles
* Reporting neck pain, shoulder pain, or headaches

Exclusion Criteria:

* History of neck or shoulder surgery or trauma
* Presence of other musculoskeletal conditions affecting the cervical spine or shoulder girdle
* Inflammatory conditions such as rheumatoid arthritis or gout
* Neurological conditions affecting upper limb function
* Pregnancy
* Uncontrolled cardiovascular or respiratory conditions
* Contraindications to manual therapy

Primary outcomes:
measure: Visual Aanalogue scale
timeFrame: 12 Months
measure: Range of motion
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Khānewāl
country: Pakistan
facility: Civil Hospital Khaniwal
state: Punjab
Study officials:
References:
Clinical trial NCT04692207: Prostate Biopsies With Target Lesion on MRI
Official title: Prostate Biopsies With Target Lesion on MRI : When Can Non-targeted Biopsies be Dispensed With
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: Targeted prostate biopsy
Non-targeted prostate biopsy
MRI
prostate
biopsy
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2020-12-31
Enrollment: 151
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who had a prostate MRI between June 2017 and March 2020 for suspected cancer, followed by targeted and non-targeted prostate biopsies (12) at the Montpellier University Hospital

Brief summary: Our objective is to search for clinical, biological and imaging element that would better define the patient population that could benefit from targeted prostate biopsies only (from a cohort of patients who had targeted and non-targeted prostate biopsies).


Eligibility criteria: Inclusion criteria:

* Age \> or = at 18 years old
* Prostatic MRI performed at the Montpellier University Hospital
* Realization of targeted prostate biopsies (by fusion of MRI - ultrasound images) and non-targeted biopsies

Exclusion criteria:

* Pre-biopsy MRI performed outside of the Montpellier University Hospital
* MRI with artefacts
* Not performing 12 non-targeted prostate biopsies

Primary outcomes:
measure: Non-targeted biopsy not finding cancer of finding cancer of a grade lower than or egal to that found on targeted biopsies
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: University hospital
Study officials:
affiliation: University Hospital, Montpellier
name: Ingrid Millet, PUPH
role: STUDY_DIRECTOR
References:
Clinical trial NCT06683807: Postdural Puncture Headache After Spinal Anesthesia for Cesarean Section
Official title: The Effect of Glass Particle Contamination From Bupivacaine Ampules on Postdural Puncture Headache After Spinal Anesthesia for Cesarean Section: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Headache
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 55
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Post-dural puncture headache (PDPH) is a potential and debilitating complication of spinal anesthesia in pregnant patients undergoing caesarean sections (CS), with a reported incidence of 0.5%-2% .

Detailed description: Various methods for the management of PDPH are present including proper hydration, maintaining a supine posture, caffeine, paracetamol, nonsteroid anti-inflammatory drugs (NSAID), theophylline, opioids like morphine and fentanyl, with the only clearly effective treatment being the epidural blood patch.

Glass particle contamination is known to occur on opening single-dose drug ampoules. Although supporting data are lacking, intrathecal drug administration during subarachnoid blocks and chemotherapy with glass particle contamination is potentially hazardous,

Eligibility criteria: Inclusion Criteria:

* Parturient with American Society of Anesthesiologists (ASA) class I or II
* Age: 20-45 years old
* A full-term pregnant female undergoing elective cesarean section under spinal anesthesia

Exclusion Criteria:

* Contraindications to regional anesthesia (coagulopathy, infection at the needle insertion site)
* History of Migraines or persistent headache
* Known hypersensitivity to local anesthetics
* Body mass index (BMI \> 35 kg/m2)
* Hypertensive disorders of pregnancy
* Emergency cesarean section
* Cardiorespiratory, hepatic, or renal impairment
* History of a cerebrovascular accident, neurologic or psychological disorders
* Uncontrolled hypertension
* Spinal column surgery, chronic opioid consumption
* Patients with more than one single attempt and patients with blood loss over 1000 mL who will need additional fluid supplementation or blood transfusion
* Patient refusal

Primary outcomes:
measure: The incidence of post-dural puncture headache (PDPH)
timeFrame: The first 120 hours during the post-partum period.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Seham M Moeen, MD
role: PRINCIPAL_INVESTIGATOR
References: