louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03097068: Analysis of Cytokines in Response to Treatment of Diabetic Macular Edema With 0.3mg Lucentis
Official title: Analysis of Cytokines in Response to Treatment of Diabetic Macular Edema With 0.3mg Lucentis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetic Macular Edema
Lead sponsor: Vitreo-Retinal Associates, Michigan
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
name: Michigan State University
First posted: 2017-03-31
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The protocol will measure a number of cytokines in addition to vascular endothelial growth factor in response to 0.3mg Lucentis.

Detailed description: Lucentis injections are the current standard of care for diabetic macular edema. The only deviation from the standard of care in the current protocol is an aqueous tap before the first Lucentis injection and the fourth Lucentis injection for diabetic macular edema.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of diabetes mellitus
* Best corrected visual acuity 20/32 - 20/320
* Diabetic macular edema involving the center of the macula
* Optical coherence tomography central subfield thickness of at least 250 microns

Exclusion Criteria:

* History of anti-vascular endothelial growth factor treatment in the past 12 months
* Any diabetic macular edema treatment in the past 4 months
* Heart attack, stroke, transient ischemic attack or acute congestive heart failure within 4 months

Primary outcomes:
measure: Vascular Endothelial Growth Factor Levels
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Grand Rapids
country: United States
facility: Vitreo-Retinal Associates
state: Michigan
Study officials:
References:
Clinical trial NCT04425746: Afamelanotide as Adjunctive Therapy in Patients Undergoing Photodynamic Therapy (PDT) Utilising Porfimer Sodium
Official title: A Phase II, Multicentre, Double-blind, Placebo Controlled, Pilot Study to Evaluate the Safety and Efficacy of CUV1647 (Afamelanotide) as Adjunctive Therapy in Patients Undergoing Photodynamic Therapy (PDT) Utilising Porfimer Sodium
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Patients Undergoing Photodynamic Therapy Using Porfimer Sodium
Lead sponsor: Clinuvel Pharmaceuticals Limited
Sponsor class: INDUSTRY
First posted: 2020-06-11
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to evaluate the safety and efficacy of afamelanotide (previously developed as CUV1647) as adjunctive therapy in patients undergoing photodynamic therapy using porfimer sodium.


Eligibility criteria: Inclusion Criteria:

* Male or female Caucasian subjects undergoing photodynamic therapy with porfimer sodium;
* Aged greater than 18 years;
* Written informed consent prior to the performance of any study-specific procedure.

Exclusion Criteria:

* Known allergy or hypersensitivity to afamelanotide or the polymer contained in the implant;
* Non-Caucasian patients;
* Personal history of melanoma or dysplastic nevus syndrome;
* Current Bowen's disease, basal cell carcinoma, squamous cell carcinoma, or other malignant or premalignant skin lesions;
* Female who is pregnant (confirmed by positive serum β-HCG pregnancy test prior to baseline) or lactating;
* Females of child-bearing potential (pre-menopausal, not surgically sterile) not using adequate contraceptive measures (i.e. oral contraceptives, diaphragm plus spermicide, intrauterine device);
* Participation in a simultaneous clinical trial for another investigational agent or within 30 days prior to the screening visit;
* Patients unable to give informed consent;
* Patient needs for concomitant medication with potential photosensitizing effects e.g. antibiotics like tetracyclines.

Primary outcomes:
measure: The First Day on Which Patients Are Free From Symptoms of Phototoxicity Following Phototesting
timeFrame: From Day 04 to Day 90
Secondary outcomes:
measure: Change in Quality of Life
timeFrame: From Day 0 to Day 20, Day 60 and Day 90
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06757946: Effect of Mulligan Medial/Lateral Glide w/wo Compression/Decompression Technique on Pain ROM and Function KO
Official title: Effect of Mulligan Medial/Lateral Glide With and Without Compression/ Decompression Technique on Pain, Range of Motion and Function on Patients With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2025-01-03
Enrollment: 54
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The Effect of Mulligan Medial/Lateral Glide Techniques with and without Compression-Decompression on Pain, Range of Motion and Function in Patients with Knee Osteoarthritis. This study aims to investigate these effects to develop more effective, non-invasive treatment protocols for improving pain, range of motion and overall function in knee OA

Detailed description: patients, for the better understanding of response by both treatments (i.e Mulligan medial/lateral glide with and without compression/decompression technique). Patient which meet inclusion criteria, gave their consent.

Eligibility criteria: Inclusion Criteria

* Unilateral Knee OA, Males and females between 30 and 60 years of age,
* Patients with restricted ROM,
* Patients are having more than grade III strength of knee muscles,
* l Willingness to take part in the intervention and evaluations

Exclusion Criteria:

* Patients having unstable knee joint after Total Knee Arthroplasty or medical conditions affecting rehabilitation,
* l Joint infection of hip and knee,
* l Soft tissue injuries around knee joints,
* including tendinitis and bursitis,
* l Any fracture including patellar fracture, femur or tibia

Primary outcomes:
measure: Pain Rating Scale (NPRS)
timeFrame: 12 Months
measure: Western Ontario and McMaster Osteoarthritis Index (WOMAC)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Services Hospital, Shadman 1
state: Punjab
Study officials:
References:
Clinical trial NCT03862846: A Study of the Safety of REN001 in Patients With Primary Mitochondrial Myopathy
Official title: An Open-label Study to Evaluate the Safety and Tolerability of 12 Weeks Treatment With Oral REN001 in Patients With Primary Mitochondrial Myopathy (PMM), With an Optional Extension of Treatment
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Primary Mitochondrial Myopathy
Lead sponsor: OnKure, Inc.
Sponsor class: INDUSTRY
First posted: 2019-03-05
Enrollment: 23
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
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 assess REN001 safety in subjects with primary mitochondrial myopathy


Eligibility criteria: Inclusion Criteria:

* Subjects must give written, signed and dated informed consent
* Confirmed diagnosis of PMM according to the 2016 Rome Consensus recommendations
* Confirmed mitochondrial mutation with evidence of myopathy
* Able to remain on stable medication throughout the study

Exclusion Criteria:

* Documented evidence of ongoing rhabdomyolysis
* Subjects with motor abnormalities other than related to mitochondrial disease
* Treatment with an investigational drug within 3 months prior to Day 1
* Hospitalised within 3 months prior to screening for any major medical condition
* Pregnant or nursing females

Primary outcomes:
measure: Adverse Events
timeFrame: Comparing Baseline to Week 12
Secondary outcomes:
measure: Adverse Events
timeFrame: Continous to Week 48
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Institute of Neurology, University College London
city: Newcastle Upon Tyne
country: United Kingdom
facility: Wellcome Centre for Mitochondrial Research
Study officials:
affiliation: Wellcome Centre for Mitochondrial Research
name: Grainne Gorman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00537446: Effect of Noninvasive Ventilation on Lung Function in Amyotrophic Lateral Sclerosis
Official title: Effect of Noninvasive Positive Pressure Ventilation on Pulmonary Function Testing in Amyotrophic Lateral Sclerosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Amyotrophic Lateral Sclerosis
Motor Neuron Disease
Keywords: noninvasive ventilation
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2007-10-01
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: Amyotrophic Lateral Sclerosis (ALS), or "Lou Gehrig's Disease", is a fatal disorder that causes progressive degeneration and weakening of the muscles of breathing, leading to breathing insufficiency and eventually breathing failure. This breathing insufficiency is commonly treated with a breathing assistance device, known as noninvasive positive pressure ventilation (NIPPV). While generally well tolerated and accepted, it is not clear whether or to what extent NIPPV in fact helps breathing function: some data suggest that NIPPV preserves breathing function over time, whereas other data suggest that it actually causes breathing function to decline more quickly. No studies have shown what the acute effect of NIPPV is on breathing muscle function in ALS patients.

This study will test the hypothesis that the acute use of NIPPV, at pressure levels that are in common clinical use, will cause measurable changes in tests of breathing function, compared to baseline and to lower levels of NIPPV. We expect that the results of this study will help to clarify whether and to what extent NIPPV assists respiratory muscle function in patients with ALS.


Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of amyotrophic lateral sclerosis
* clinical indication to start noninvasive ventilation (forced vital capacity \< 50% predicted or signs/symptoms of respiratory insufficiency)
* age 18 to 80 years old

Exclusion Criteria:

* prior institution of NIPPV
* inability to safely use NIPPV
* indications for tracheostomy assisted ventilation because of inability to clear secretions from the airway
* inability or unwillingness to perform pulmonary function testing
* presence of advanced dementia.

Primary outcomes:
measure: Difference in Pulmonary Function and Respiratory Muscle Pressure Testing
timeFrame: 5 hours
measure: Difference in Gas Exchange
timeFrame: 5 hours
measure: Difference in Subjective Dyspnea Between Baseline and the Two Different Ventilator Modes
timeFrame: 5 hours
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Eleanor and Lou Gehrig ALS/MDA Center at Columbia University
state: New York
Study officials:
affiliation: Columbia University
name: Robert C Basner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00095446: NovoLog Observation Trial in Subjects With Type 1 and Type 2 Diabetes
Official title: An Open-Label, Multi Center, Clinical Trial: External Continuous Subcutaneous Infusion of Insulin Using Insulin Aspart (NovoLog®) in Subjects With Type 1 and Insulin Requiring Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Keywords: Diabetes Mellitus
Diabetes
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2004-11-05
Enrollment: 513
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This trial is conducted in the United States of America (USA). The aim of this trial is to assess control of blood sugar, safety, and patient acceptance of insulin aspart compared to insulin lispro, both in insulin pumps, in standard clinical practice.


Eligibility criteria: Inclusion Criteria:

* People with Type I or Type II Diabetes
* 18 Years or Older.

Primary outcomes:
measure: Treatment satisfaction with insulin pump therapy
Secondary outcomes:
measure: body weight
measure: Insulin dose
measure: Overall glycemic control
measure: number and types of infusion sets used.
measure: infusion set in-use times
Other outcomes:
Locations:
city: Princeton
country: United States
facility: Novo Nordisk Investigational Site
state: New Jersey
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR,1452)
role: STUDY_DIRECTOR
References:
citation: Wittlin SD, Marcus AO, Weng CS, Howard CP, Schorr AB; CONTROL Study Group. Evaluation of treatment satisfaction associated with the use of insulin aspart in continuous subcutaneous insulin infusion. Diabetes Technol Ther. 2008 Feb;10(1):1-10. doi: 10.1089/dia.2007.0234.
Clinical trial NCT06160869: Effect of Acceptance and Commitment Therapy on Psychotic Severity
Official title: Efficacy of Acceptance and Commitment Therapy on Psychotic Severity Among Inpatients With Primary Psychosis: A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Psychosis
Emotion Regulation
Recovery
Keywords: Psychosis
Emotional regulation
Recovery
Lead sponsor: Port Said University
Sponsor class: OTHER
First posted: 2023-12-07
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Current study is an open label, two-arm, parallel, randomized controlled trial, evaluating the efficiency of Acceptance and Commitment Therapy (ACT) added to treatment as usual (TAU) as opposed to treatment as usual (TAU) alone on patients with schizophrenia. The study adheres to the rules for writing Clinical Trials: "The Consolidated Standards of Reporting Trials" (CONSORT) statement
Primary purpose: SUPPORTIVE_CARE

Brief summary: Our study aims to assess the efficacy of Acceptance and Commitment Therapy on psychotic severity among Inpatients with primary psychosis: A Randomized Controlled Trial.

Detailed description: Current study was an open label, two-arm, parallel, randomized controlled trial, evaluating the efficiency of Acceptance and Commitment Therapy (ACT) added to treatment as usual (TAU) as opposed to treatment as usual (TAU) alone on patients with schizophrenia. The study adheres to the rules for writing Clinical Trials: "The Consolidated Standards of Reporting Trials" (CONSORT) statement

Eligibility criteria: Inclusion criteria Participants' criteria of inclusion involved those patients who were

1. Current psychiatric hospitalization;
2. DSM-5 diagnosis of a primary psychotic disorder; (schizophrenia, schizoaffective disorder, delusional disorder, schizophreniform disorder, brief psychotic disorder, and unspeciﬁed psychotic disorder, this diagnosis was confirmed by a psychiatrist
3. 18 years or older;
4. ability to talk, read and write in Arabic; and
5. willingness to participate in the study that was scheduled for seven weeks.

Exclusion criteria Patients were excluded if they

1. had a comorbid learning disability or organic brain disorder;
2. psychosis related to a general medical condition or substance-induced psychotic disorder;
3. were considered mentally unstable; or
4. unfit to participate in the study by their therapist, and/or had newly had (been receiving) psycho-education or somewhat designed psychosocial intervention.

Primary outcomes:
measure: Positive and Negative Syndrome Scale (PANSS)
timeFrame: 7 weeks
Secondary outcomes:
measure: Difficulties in Emotion Regulation Scale
timeFrame: 7 weeks
measure: Recovery Assessment Scale
timeFrame: 7 weeks
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University
state: Dakahlia
Study officials:
affiliation: Mansoura University
name: Mohamed Zoromba, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01670669: Prucalopride in Paediatric Subjects, With Functional Faecal Retention
Official title: An Open-label Follow-up Study of 0.01 mg/kg/Day to 0.03 mg/kg/Day Prucalopride (R108512) Oral Solution in Paediatric Subjects, Aged >= 4 to <= 12 Years With Functional Faecal Retention (FFR), Who Participated in the PRU-USA-12.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Constipation
Lead sponsor: Movetis
Sponsor class: INDUSTRY
First posted: 2012-08-22
Enrollment: 37
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is characterize the efficacy, safety, tolerability, and steady-state plasma levels after once-daily oral dosing of prucalopride (R108512) as a solution, 0.01 mg/kg to 0.03 mg/kg, given to paediatric subjects with functional faecal retention (FFR) for 8 weeks.

Hypothesis:

Pharmacokinetic profile of prucalopride in paediatric subjects is expected to resemble the adult pharmacokinetic profile. Safety and tolerability profile are expected to resemble the adult profile.

Detailed description: This is a multicentre, open-label trial in which paediatric subjects (ages 4 to 12 years) with FFR were administered prucalopride in oral solution once daily for 8 weeks. Subjects who entered this extension trial had completed PRU-USA-12, a single-dose pharmacokinetic trial, usually within the previous week.

Evaluations for efficacy, safety and tolerability were performed, and plasma samples for analysis of prucalopride levels were obtained at 2, 4, 6 and 8 weeks.

The initial dosage of prucalopride oral solution was 0.02 mg/kg/day. Dependent on the subject's response, the parent could adjust the dosage within a range of 0.01 mg/kg/day to 0.03 mg/kg/day.

Eligibility criteria: Inclusion Criteria:

* Subject completed the PRU-USA-12 pharmacokinetic trial
* Subject bowels had been "cleaned-out" (ie, any faecal impactions removed)
* Written informed consent, signed by the subject's legal guardian and by the investigator
* Subject assent documented in the form of a note-to-file in the subject's source documentation

Exclusion Criteria:

• No exclusion criteria

Primary outcomes:
measure: Adverse events
measure: Efficacy
Secondary outcomes:
measure: Secondary efficacy variables: steady-state plasma levels after once-daily oral dosing of prucalopride (R108512) as a solution, 0.01 mg/kg to 0.03 mg/kg, given to paediatric subjects with functional faecal retention (FFR) for 8 weeks.
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Massachusetts General Hospital for Children, Boston, Massachusetts, USA
name: Harald Winter, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Winter HS, Di Lorenzo C, Benninga MA, Gilger MA, Kearns GL, Hyman PE, Vandeplassche L, Ausma J, Hoppenbrouwers M. Oral prucalopride in children with functional constipation. J Pediatr Gastroenterol Nutr. 2013 Aug;57(2):197-203. doi: 10.1097/MPG.0b013e318292f9ea.
Clinical trial NCT03831269: Pityriasis Lichenoides Chronica, Role of Streptococcal Infection and Azithromycin
Official title: Role of Streptococcal Infection in the Etiopathogenesis of Pityriasis Lichenoides Chronica and the Therapeutic Efficacy of Azithromycin; a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pityriasis Lichenoides
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-02-05
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Primary outcome:

The primary outcome at end of study (EOS) is to compare the therapeutic efficacy of Azithromycin in the treatment of pityriasis lichenoides chronica (PLC) with that of a well-documented line of therapy namely narrow band ultra violet B (nbUVB).

Secondary outcomes:

1. To identify the possibility of streptococcal throat infection as a possible underlying etiology in PLC.


Eligibility criteria: Inclusion Criteria:

1. Patients with classic papular eruption of PLC (scaly erythematous papules with mica-like scales) with diagnosis documented histopathologically with or without associated hypopigmented lesions
2. Age: \> 6 years
3. Both sexes.

Exclusion Criteria:

1. Patients presenting with only hypopigmented macules whom their skin biopsy revealed PLC.
2. Patients with hypopigmented lesions that reveal mycosis fungoides pathologically.
3. Patients with PLC associated with classic MF.
4. Patients with known absolute contraindications to NB-UVB.
5. Patients with impaired liver and/or kidney functions.
6. Patients with history of any heart disease.
7. Patients with known hypersensitivity to Azithromycin

   -

Primary outcomes:
measure: Efficacy of Azithromycin in treating pityriasis lichenoides chronica
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Alainy Faculty of Medicine Cairo University
Study officials:
References:
citation: Elbendary A, Youssef R, Abdel-Halim MRE, Abdel Halim D, El Sharkawy DA, Alfishawy M, Gad MA, Gad A, Elmasry MF. Role of streptococcal infection in the etiopathogenesis of pityriasis lichenoides chronica and the therapeutic efficacy of azithromycin: a randomized controlled trial. Arch Dermatol Res. 2023 Apr;315(3):521-530. doi: 10.1007/s00403-022-02398-0. Epub 2022 Sep 21.
Clinical trial NCT00413569: The Effect of Intubation Method on Outcome of Cervical Spine Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Pain
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2006-12-19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: DEFINED_POPULATION
Time perspective: RETROSPECTIVE

Brief summary: The specific aim of this study is to demonstrate that inserting a breathing tube using a standard laryngoscope with the patient fully anesthetized is a safe and effective means of securing the airway in a patient with cervical spine disk herniation or stenosis. The two groups compared are composed of those who are intubated with direct laryngoscopy and those who are intubated with a fiberoptic scope.


Eligibility criteria: Inclusion Criteria:

* Over 18 years of age for cervical disk herniation or cervical spine surgery by either Drs Snow or Lavyne from 1998-2006.

Exclusion Criteria:

* Unstable (broken) cervical spine

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Weill Medical College of Cornell University
name: Scott D Solomon, MD
role: PRINCIPAL_INVESTIGATOR
References: