louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01942421: Ocular Surface Reconstruction With Cultivated Autologus Mucosal Epithelial Transplantation
Official title: Ocular Surface Reconstruction With Cultivated Autologus Mucosal Epithelial Transplantation.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Ocular Surface Disease
Keywords: Limbal deficiency
Cultivated limbal transplantation
Ex vivo limbal transplantation
Cultivated autologous mucosal epithelial transplantation
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2013-09-16
Enrollment: 20
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: The purpose of this study is to elucidate the appropriate condition of developing cultivated autologous oral mucosal epithelial graft and evaluate the surgical outcome of transplantation of the cultivated cells in the patients.

Detailed description: Ocular surface damage caused by severe ocular surface diseases. Corneal limbal stem cell transplantation has been demonstrated to improve the outcome of ocular surface reconstruction. However, the conventional management of allograft limbal transplantation generally has unsatisfactory outcome because of high risk of rejection and requires long-life immunosuppressive medications. Ocular surface reconstruction with cultivated autologous mucosal epithelial transplantation is served to improve the surgical results of ocular surface reconstruction and decrease the use of immunosuppressive medications

Eligibility criteria: Inclusion Criteria:

* Bilateral limbal stem cell deficiency proved by specific clinical features and impression cytology

Exclusion Criteria:

* Age under 18
* Active ocular infection, Severe dry eye, Uncontrolled glaucoma
* Immunocompromised host
* Pregnancy

Primary outcomes:
measure: Ocular surface clinical and pathological status(signs of limbal deficiency and immunopathological markers)after the surgery
timeFrame: Three years
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Pinnita Prabhasawat, MD
Study officials:
affiliation: Mahidol University
name: Pinnita Prabhasawat, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03251521: Pain During Injection With Botulinum Toxin in Post-stroke Spasticity Treatment
Official title: Evaluation of Pain Intensity in Different Steps of Injection With Botulinum Toxin in the Treatment of Spasticity in Post-stroke Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post-stroke Spasticity
Keywords: pain
spasticity
stroke
injection
botulinum toxin A
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2017-08-16
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients were assessed during routine botulinum toxin injection in the day clinic of our department

Brief summary: The aim of the study was to analyze which step of the procedure of toxin botulinum injection is the most painful between skin break-in, electric stimulation, injection and needle withdrawal.

Detailed description: Post-stroke spasticity management by botulinum toxin injections may be limited by pain or discomfort at the injection side.

Particularly tracking by electrostimulation, but also skin puncture, toxin injection or needle withdrawal may be painful.

The objective of this study is to define an individual injection strategy in order to limit pain.

Eligibility criteria: Inclusion Criteria:

* stroke
* severe upper or lower limb spasticity (Ashworth score ≥ 2 for at least one muscle)
* patients requiring a treatment by botulinum toxin
* patients refusing analgesia for injections.

Exclusion Criteria:

* severe aphasia (severity subscore of the BDAE \<3)
* cognitive impairment or psychiatric disease altering the reliability of pain evaluation
* patient medically unstable.

Primary outcomes:
measure: Evolution of pain intensity during injection with botulinum toxin
timeFrame: 30 min
Secondary outcomes:
measure: Hypoesthesia
timeFrame: 30 min
measure: Neuropathic pain
timeFrame: 30 min
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Grenoble
name: Dominic PERENNOU, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04452721: Prognosis Factors for the Treatment of Pectus Carinatum With a Dynamic Compression System
Official title: Prognosis Factors for the Treatment of Pectus Carinatum With a Dynamic Compression System
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pectus Carinatum
Keywords: Pectus Carinatum
Dynamic compression system
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2020-06-30
Enrollment: 520
Sex: ALL
Minimum age (years): 6
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Refusal to participate to this treatment

Brief summary: Pectus carinatum is a deformation of the thoracic wall causing an aesthetic prejudice. Since 2011, our team uses a dynamic compression system to treat this deformation. It is a harness that the patient wears all day long for an average duration of 1 year, and that remodels the chest by exerting a moderate pressure on it. The local cohort is one of the largest in the world. The few previous publications have shown the validity of this method, but the prognosis factors for success of this innovative treatment are not yet identified.

Detailed description: The principal insvestigator hypothesizes that the success or failure of the treatment depends on several parameters assessable before treatment, such as the patient's age, gender, initial correction pressure, symmetry or not of the deformation.

Eligibility criteria: Inclusion Criteria:

* Patient who received proper information about the study.
* Patient with clinically diagnosed pectus carinatum.
* Treated at Saint-Etienne University Hospital using a dynamic compression system.
* Between October 2011 and January 2020 for the retrospective part, then between January 2020 and January 2022 for the validation cohort.
* With more than 6 months of follow-up since the beginning of the treatment.

Exclusion Criteria:

-

Primary outcomes:
measure: Decrease of the deformation of more than 50% (measured in mm) after 6 months of treatment
timeFrame: After 6 months of treatment
Secondary outcomes:
measure: Failure of treatment assessed by the patient, ie if the patients considers the treatment to have failed, if he choose to underwent surgery afterwards, or if he considered the pectus carinatum to have relapsed
timeFrame: After the end of treatment (6 months to 2 years)
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: CHU de Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Aurélien SCALABRE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01191021: Monitoring Exhaled Propofol to Individualize General Anesthesia
Official title: Pilot Study to Estimate Central Propofol Effect by Measuring Exhaled Propofol Concentrations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: General Anesthesia
Keywords: breath
propofol
general anesthesia
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2010-08-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: This trial investigates the relationship between concentrations of the anesthetic drug propofol in exhaled breath, blood and drug effect in volunteers undergoing general anesthesia. The main goal of this study is to develop a pharmacokinetic - and dynamic model for propofol in exhaled breath.


Eligibility criteria: Inclusion Criteria:

* 18 years of age

  * Written informed consent
  * Ability and willingness to give written informed consent
  * American Society of Anesthesiologists (ASA) risk score I

Exclusion Criteria:

* Volunteers ASA physical status II - III
* Pregnancy
* Volunteers with history of neurological disease or stroke
* Volunteers with a history of recreational drug abuse
* Volunteers with a history of alcohol abuse
* Smokers
* Anesthesia within 6 months
* Known drug allergies
* History of adverse events during general anesthesia

Primary outcomes:
measure: Exhaled propofol (parts per billion)
timeFrame: Continuous measurement over 90 min
measure: Processed electroencephalography (Bispectral Index (0-100)): Change from baseline during anesthesia
timeFrame: continuous over 90 min
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Department of Anesthesia and Perioperative Care, UCSF
state: California
Study officials:
affiliation: Perioperative Clinical Research Core, Department of Anesthesia, University of California San Francisco
name: Christian C Apfel, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Perioperative Clinical Research Core, Department of Anesthesia, University of California San Francisco
name: Cyrill Hornuss, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hornuss C, Praun S, Villinger J, Dornauer A, Moehnle P, Dolch M, Weninger E, Chouker A, Feil C, Briegel J, Thiel M, Schelling G. Real-time monitoring of propofol in expired air in humans undergoing total intravenous anesthesia. Anesthesiology. 2007 Apr;106(4):665-74. doi: 10.1097/01.anes.0000264746.01393.e0.
Clinical trial NCT06548321: Benefits of Extracorporeal Shockwave Therapy to Reduce Spasticity in Stroke/CP
Official title: Benefits of Extracorporeal Shockwave Therapy to Reduce Spasticity in Stroke/CP
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Stroke, Cerebral
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2024-08-12
Enrollment: 28
Sex: ALL
Minimum age (years): 10
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This Study will help to explain us that ExtracorporealShockwave therapy can reduce spasticity in Stroke Patient,help them to restore their abilities and ROM.Therapy reduces dependency rate of patient.Also seen this therapy shows reduction in spasticity of CP child population.Improving the motor recovery.

Detailed description: ESWT therapy increses molecular and immunological reactions,increase blood microcirculation and neurovascularization.It enhancing the neural proliferation of neural stem cell(NSC),which shows repair in brain function in CNS diseases.Extracorporeal shockwave can produce Nitric oxide in enzymatic and non enzymatic way which help, to reduce muscle spasm.Extracorporeal Shockwave reduce the exitibilty of motor neuron by vibratory stimulation of tendon and reduces tension.After 2 weeks ESWT muscle tension reduces increases range of motion reduces the pain.shock wave therapy appears to be effective in reducing spasticity levels irrespective of the age of the participants, the type of injury, and the tool used to measure the effect.ESWT change in motor neuron exitibilty \& also associated with the spastic muscle.

Eligibility criteria: Inclusion Criteria:

* 3rd stage of Stroke

Exclusion Criteria:

* Non spastic CP,1st stage of Stroke,Spasticity caused by injury,Newborn

Primary outcomes:
measure: Modified Ashworth Scale MAS
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Clinical setups Sargodha,Lahore,BWN
Study officials:
References:
Clinical trial NCT00409721: The Effect of Memantine on Functional Outcomes and Motor Neuron Degeneration in Amyotrophic Lateral Sclerosis (ALS)
Official title: A Randomized, Double-blind, Dose Ranging Study to Determine the Effect of Memantine on Functional Outcomes and Motor Neuron Degeneration in Patients With ALS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Amyotrophic Lateral Sclerosis
Keywords: Amyotrophic Lateral Sclerosis
ALS
Motor Neuron Disease
MND
Memantine
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: ALS Association
First posted: 2006-12-11
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to investigate the effects of memantine in ALS patients using functional outcome measures.


Eligibility criteria: Inclusion Criteria:

* El Escorial Classification of laboratory supported probable, probable,or definite ALS
* Age 18 - 80 years,
* ALS symptoms for no more than 3 years,
* FVC greater than or equal to 60% predicted,
* Riluzole naïve or have been on a stable dose of Riluzole for at least 2 months,
* Patients must have the ability to attend monthly study visits in Edmonton or Calgary, Alberta

Exclusion Criteria:

* Presence of significant sensory abnormalities, dementia, other neurologic diseases, uncompensated medical illness and psychiatric illness
* Female patients who are breastfeeding
* Use of concurrent investigational drugs,
* Patient unlikely to comply with study requirements
* Poor adherence to study protocol during run-in phase

Primary outcomes:
measure: ALS Functional Rating Scale-Revised (ALSFRS-R)
measure: Forced vital capacity (FVC)
measure: Manual Muscle Testing (MMT)
measure: Addenbrooke Cognitive Examination (ACE)
Secondary outcomes:
measure: Motor unit number estimates of hand and foot muscles
measure: N-acetylaspartate in the motor cortex
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Calgary ALS Neuromuscular Clinic
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta ALS Clinic
state: Alberta
Study officials:
affiliation: University of Alberta
name: Ming Chan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alberta
name: Sanjay Kalra, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06370221: The Effect of Psoriatic Arthritis on Female Sexual Dysfunction
Official title: The Effect of Psoriatic Arthritis on Female Sexual Dysfunction and Their Relation to Sex Hormones
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Psoriatic Arthritis
Lead sponsor: Egymedicalpedia
Sponsor class: INDUSTRY
First posted: 2024-04-17
Enrollment: 180
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The female sexual function index (FSFI) is a self-reported questionnaire that has been validated in Arabic, and is used to measure a woman's sexual function over the course of the past four weeks.

A reliable and accurate way to assess female sexual function is the FSFI. The six domains of sexual function-desire, arousal, lubrication, orgasm, satisfaction, and pain-are assessed by the 19 questions in this questionnaire. The response is scored between 0 and 5 on a 5-point Likert scale.

Disease Activity in Psoriatic Arthritis (DAPSA) Helps measure disease activity in psoriatic arthritis based on joint symptoms, CRP and pain evaluation

Brief summary: Psoriasis is one of the most common immunemediated chronic inflammatory skin disorders.

Detailed description: Psoriasis is one of the most common immunemediated chronic inflammatory skin disorders.

Beside genetic factors, several environmental factors such as injuries, infections, stress, drugs, and immune defect take part in autoimmune pathogenesis of the disease. In addition, it has been reported that some hormones may also have a role in the pathogenesis of psoriasis, due to their effects on keratinocytes proliferation.

Studies revealed that sex hormones manifest a variety of biological and immunological effects in the skin which modulate the natural course of psoriasis.

Approximately 20-30% of patients with psoriasis may also have psoriatic arthritis, which often causes significant musculoskeletal pain that significantly impairs quality of life (QoL).

Although sexual dysfunction is a common complaint, affecting 30 to 70% of psoriasis patients, few studies have analyzed the impact of psoriasis and psoriatic arthritis on quality of sexual life.

Eligibility criteria: Inclusion Criteria:

* The study will focuses on the relationship between the FSD and PsA;
* The healthy controls will derive from a population within the same geographic area and ethnic background as PsA;
* Used the same questionnaires/instruments of FSFI to diagnose FSD

Exclusion Criteria:

* pregnancy,
* breastfeeding
* being sexually inactive
* having a partner with sexual dysfunction,
* refusing to participate, or
* being unable to read
* Females with any sexual transmitted disease

Primary outcomes:
measure: Evaluation of female sexual function
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Qinā
country: Egypt
facility: Qena Hospital
Study officials:
References:
Clinical trial NCT03287921: Diagnostic and Therapeutic Approaches to Hyperinflation and Small Airway Disease in COPD
Official title: Diagnostic and Therapeutic Approaches to Hyperinflation and Small Airway Disease in COPD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
Keywords: pulmonary care
COPD
small airway disease
hyperinflation
Lead sponsor: Universitätsmedizin Mannheim
Sponsor class: OTHER
First posted: 2017-09-19
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: hospitalized patients and out-patients with known or firstly diagnosed COPD

Brief summary: Current guideline-based criteria defining COPD do not meet the challenges set by the complex pathophysiology of the disease. Hyperinflation and affection of the small airways are two components that are not represented in current diagnostic concepts and may relate to early stages of the disease. Moreover, optimal therapeutic interventions in patients with these distinct features remain unclear. The investigators therefore aimed to evaluate novel or not widely used diagnostic approaches for the detection and initiating therapeutic strategies in early stage COPD within the GOLD recommendations.


Eligibility criteria: Inclusion Criteria:

* known or first diagnosis of COPD
* lung function testing consistent with hyperinflation or peripheral obstruction
* emphysema in imaging
* symptoms (dyspnea, cough, sputum) and risk factors (\>= 10 pack years)
* indication for bronchodilator therapy

Exclusion Criteria:

* GOLD stages 3 and 4 (spirometric)
* indication for dual bronchodilator therapy, triple therapy or inhaled steroid
* contraindication for cardiopulmonary exercise testing
* unwilling to participate

Primary outcomes:
measure: residual volume
timeFrame: 8 weeks
measure: D5-20
timeFrame: 8 weeks
measure: LCI
timeFrame: 8 weeks
Secondary outcomes:
measure: tpeak
timeFrame: 8 weeks
measure: IC
timeFrame: 8 weeks
measure: SGRQ
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: University Medical Center Mannheim
Study officials:
affiliation: University Medical Center Mannheim
name: Frederik Trinkmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00946621: To Demonstrate the Relative Bioavailability Study of Ramipril 10 mg Capsules Under Non-Fasting Conditions
Official title: A Relative Bioavailability Study of Ramipril 10 mg Capsules Under Non-Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypertension
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2009-07-27
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To demonstrate the relative bioavailability study of Ramipril 10 mg capsules under non-fasting conditions.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.

Primary outcomes:
measure: Bioequivalence based on AUC and Cmax
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Cetero Research, San Antonio
name: Steven Herrmann, M.D., PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03352921: Efficacy Of Clinical Pilates Exercises İn Desk-Based Workers With Sagital Cervical Disorientation
Official title: Efficacy Of Clinical Pilates Exercises İn Desk-Based Workers With Sagital Cervical Disorientation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sagital Cervical Disorientation
Keywords: clinical pilates
exercise
Sagital Cervical Disorientation
Disorientation
Forward Head Posture
Lead sponsor: Eastern Mediterranean University
Sponsor class: OTHER
First posted: 2017-11-24
Enrollment: 46
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the effects of clinical pilates exercises and home exercise program on postural disorders, pain intensity, normal range of motion, muscle strength, endurance, muscle shortness, joint position sense and functional status in desk workers with sagittal cervical disorientation.


Eligibility criteria: Inclusion Criteria:

* Neck pain at least for three months,
* Anterior head translation of sagittal segmental alignment disorders,
* Craniovertebral angle as \<50 degree,
* Desk-work minimum for 3 years,
* Working with the computer daily at least for 5 hours,
* Less severe physical activity level according to the International Physical Activity Questionnaire.

Exclusion Criteria:

* Taken any physiotherapy program for the last 6 months due to neck or back pain complain,
* Pain severe 3 cm or less according to the Visual Analog Scale (VAS),
* Structural scoliosis,
* Broken neck history
* Rheumatic disorder that affects the neck,
* Acute torticollis,
* Vertebral column surgical history,
* Spinal cord compression due to tumor or other reasons,
* Neurological deficit,
* Temporomandibular joint problem,
* Taking any kind of pain killers except for basic analgesics.

Primary outcomes:
measure: Postural Disorders
timeFrame: eigth weeks
Secondary outcomes:
measure: Cervical Joint Position Sense
timeFrame: 8 weeks
measure: Normal Motion of Cervical Joint
timeFrame: 8 weeks
measure: Muscle Strength
timeFrame: 8 weeks
measure: muscle endurance
timeFrame: 8 weeks
measure: Neck pain
timeFrame: 8 weeks
measure: disability scale
timeFrame: 8 weeks
measure: muscle shortness
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Famagusta
country: Cyprus
facility: Eastern Mediterranean University
Study officials:
References:
citation: Hurer C, Angin E, Tuzun EH. Effectiveness of clinical Pilates and home exercises in sagittal cervical disorientation: randomized controlled study. J Comp Eff Res. 2021 Apr;10(5):365-380. doi: 10.2217/cer-2020-0186. Epub 2021 Mar 12.