louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02512510: Efficacy Study of Nebulized TD-4208 for Chronic Obstructive Pulmonary Disease (COPD)
Official title: A Phase 3, 12-week, Randomized, Double-blind Placebo-controlled Parallel Group Study of Nebulized TD-4208 in Subjects With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Chronic Obstructive Pulmonary Disease, COPD
Lead sponsor: Viatris Inc.
Sponsor class: INDUSTRY
Collaborators: name: Theravance Biopharma
First posted: 2015-07-31
Enrollment: 611
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to measure the effectiveness and safety of TD 4208, an investigational drug being developed to treat people with moderate to very severe COPD, compared to placebo, a treatment without activity.


Eligibility criteria: Inclusion Criteria:

* Subject is a male or female subject 40 years of age or older

Exclusion Criteria:

* Females who are pregnant, lactating, breast-feeding or planning to become pregnant during the study

Primary outcomes:
measure: Change From Baseline in Trough FEV1 on Day 85
timeFrame: Baseline and Day 85
Secondary outcomes:
measure: Summary of Trough FEV1 Overall Treatment Effect From Day 15 to Day 85
timeFrame: Days 15 to 85
measure: Summary of Change From Baseline to Peak FEV1 After First Dose
timeFrame: 0-2 hours after First Dose Day 1
measure: Summary of Rescue Medication Use: Puffs Per Day
timeFrame: 1-3 Months
measure: St. George's Respiratory Questionnaire (SGRQ) Proportion of Responders on Day 85
timeFrame: Day 85
measure: Percentage of Albuterol Rescue-free 24-hour Periods
timeFrame: 1-3 Months
Other outcomes:
Locations:
city: Easley
country: United States
facility: Palmetto Medical Research Associates L.L.C.
state: South Carolina
Study officials:
affiliation: Theravance Biopharma
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Lo A, Borin MT, Bourdet DL. Population Pharmacokinetics of Revefenacin in Patients with Chronic Obstructive Pulmonary Disease. Clin Pharmacokinet. 2021 Mar;60(3):391-401. doi: 10.1007/s40262-020-00938-3.
citation: Donohue JF, Kerwin E, Barnes CN, Moran EJ, Haumann B, Crater GD. Efficacy of revefenacin, a long-acting muscarinic antagonist for nebulized therapy, in patients with markers of more severe COPD: a post hoc subgroup analysis. BMC Pulm Med. 2020 May 11;20(1):134. doi: 10.1186/s12890-020-1156-4.
Clinical trial NCT01317810: A Study Measuring and Tracking Changes in Overactive Bladder (OAB) Medication
Official title: A Phase 4, Observational, Non-interventional Study Measuring and Tracking Changes in Overactive Bladder Medication and/or Overactive Bladder Medication Dose in Subjects With Overactive Bladder
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Overactive Bladder (OAB)
Keywords: Overactive Bladder (OAB)
Observational
Registry
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2011-03-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with overactive bladder (OAB)

Brief summary: The purpose of this study is to track changes in overactive bladder (OAB) medical regimen and/or OAB medication dosage requirements.

Detailed description: Subjects will complete a study specific survey questionnaire at Screening and the Month 1 through Month 6 visits. Subjects will be followed for 6 months.

Eligibility criteria: Inclusion Criteria:

* Subject has overactive bladder as determined by their prescribing physician
* Subject is currently receiving pharmacotherapy for overactive bladder
* Subject is willing to comply with required protocol/study requirements

Exclusion Criteria:

* Subject has a history of a clinically significant illness or medical condition prior to screening that would preclude participation in the study
* Male subjects with Lower Urinary Tract Symptoms (LUTS) or Bladder Outlet Obstruction (BOO)

Primary outcomes:
measure: Change in overactive bladder (OAB) medication/ treatment regimen
timeFrame: 6 months
measure: Reason for change in OAB medication/treatment regimen
timeFrame: 6 months
Secondary outcomes:
measure: Persistence of use of any OAB medication as reported by the Physician
timeFrame: 6 months
measure: Change in OAB medication including discontinuation of OAB medication as reported by the Physician
timeFrame: 6 months
measure: Subject reported efficacy
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Astellas Pharma Global Development, Inc.
name: Use Central Contact
role: STUDY_DIRECTOR
References:
Clinical trial NCT05055310: The Mechanism of MicroRNAs Network in Alzheimer's Disease
Official title: Shanghai Mental Health Center
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer Disease
Keywords: MicroRNAs
Alzheimer's Disease
Validation
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2021-09-24
Enrollment: 1000
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: age between 60 to 90 years old.

Brief summary: MicroRNAs network, such as MicRNA107 et al, regulate the pathology of Alzheimer's disease and the clinical validation in diagnosis AD.


Eligibility criteria: Inclusion Criteria:

* NIA-AA MCI due to AD clinical criteria for MCI due to AD
* NIA-AA AD clinical criteria for AD

Exclusion Criteria:

* Other type of dementia

Primary outcomes:
measure: MicRNAs diagnosis validation for aMCI
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Psychogeriatrics，Shanghai Mental Health Center
state: Shanghai
Study officials:
References:
Clinical trial NCT02179710: Cystic Fibrosis Treatment Adherence Cayston Proof-of-Concept Pilot Study
Official title: Cystic Fibrosis Treatment Adherence Cayston Proof-of-Concept Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystic Fibrosis
Keywords: adherence
cystic fibrosis
adolescents
adults
Lead sponsor: Landon Pediatric Foundation
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
First posted: 2014-07-02
Enrollment: 18
Sex: ALL
Minimum age (years): 8
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with cystic fibrosis over age 8 with difficulties with adherence to aerosolized Caysotn

Brief summary: Real-world adherence to inhaled and oral therapies for cystic fibrosis (CF) patients remains discouragingly low, ranging between 31-53% for inhaled antibiotics and 41-72% for hypertonic saline. Programs to enhance adherence, including comprehensive behavioral interventions with adolescents, have met with mixed success. Advances in therapy, treatment delivery systems, and data capture technology offer the potential for enhancing adherence by providing immediate and more frequent feedback to the patient regarding his or her fidelity to the prescribed treatment regimen. We propose to conduct a proof-of-concept study to evaluate a systematic approach to linking treatment and feedback components to enhance adherence.

Detailed description: Study Design: This will be a single group intervention involving a 28-day baseline (Phase 1), a 28-day treatment period with enhanced adherence feedback. Subjects will be treated with Cayston via a blue tooth enabled nebulizer.

Eligibility criteria: Inclusion Criteria:

* Subjects will be 18 non-adherent CF patients
* Stratified by age as adult supervised (8-12) adolescents (12-18) and young adults (19-30) and gender
* Balanced for ethnicity and disease severity -Non-adherence status will be determined at screening based on an MAQ score \< 6. -

Exclusion Criteria:

* Inability to give informed consent or assent

Primary outcomes:
measure: Remotely Observed Therapy
timeFrame: 140 days
Secondary outcomes:
measure: Morisky Adherence Questionnaire
timeFrame: 140 days
Other outcomes:
Locations:
city: Ventura
country: United States
facility: Pediatric Diagnostic Center
state: California
Study officials:
affiliation: Landon Pediatric Foundation
name: Chris Landon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00457210: The Influence of Radiotherapy on Cognitive Function
Official title: The Influence of the Radiotherapy or Stereotactic Radiosurgery on the Cognitive Function of the Patients With the Neurotrax Assessment System and a Cognitive Questionnaire.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Radiotherapy
Brain Neoplasms
Quality of Life
Keywords: Psychology
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Mindstreams
First posted: 2007-04-06
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: The cognitive function of 150 patients that undergone any Radiotherapy treatment to the brain will be assessed at 3 time points before and after the treatment.

Detailed description: The basic cognitive function and QOL of 150 oncologic patients that undergone Radiotherapy or Radiosurgery treatment to the brain due to primary tumor, metastases or increased risk of brain metastases, will be assessed at 3 time points: before the treatment, immediately after the treatment, and on the next follow up visit. The assessment tools that will be used are Neurotrax standard cognitive computerized tests and 2 short questionnaires.Patients that will receive a one-day treatment will be tested on 2 time points only- before the treatment and on FU.The research will reveal the positive and the negative influences of the Radiotherapy, along with the assessment of norms for the cognitive function and quality of life of oncologic patients being treated by RT.Eligibility criteria:oncologic patients of both genders, with primary brain tumors, metastases or with increased risk of brain metastases, that are referred to conformal/palliative or preventive Radiotherapy treatment or to Stereotactic Radiosurgery, who are able to follow instructions in Hebrew.The participants will be 20-80 years old.Main comparisons will be performed between the cognitive tests results on 3 time points mentioned. The study will continue until the needed number of participants will be achieved.

Eligibility criteria: Inclusion Criteria:

* 20-80 years old oncologic patients, of both genders, that are referred to Brain Radiotherapy or Stereotactic Radiosurgery due to primary brain tumor/ brain metastases or increased risk for brain metastases.
* Are able to follow instructions in Hebrew.

Exclusion Criteria:

* Non-Hebrew speakers can not participate.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv sourasky Medical Center
Study officials:
affiliation: Tel-Aviv Sourasky Medical Center
name: Ben Corn, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03161210: Evaluation of Pain Regression in Patients With Myofascial Facial Pain Using Dextrose, Local Anaesthesia and Saline.
Official title: Evaluation of Pain Regression in Patients With Myofascial Facial Pain Treated by Dextrose Prolotherapy Versus Local Anesthetic Injections: A Prospective Double-blind Randomized Placebo-controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Myofascial Pain Syndrome
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-05-19
Enrollment: 80
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 aim of this study is to compare the treatment effects of dextrose prolotherapy, saline, and mepivacaine for deactivating myofascial trigger points within the jaw muscles.


Eligibility criteria: Inclusion Criteria:

- 1. Presence of active myofacial pains in jaw muscles, previously identified by manual palpation.

2. Age ≥ 18 years. 3. Willingness to follow instructions

Exclusion Criteria:

* 1. Therapeutic intervention for myofascial pain within the past month before the study, such as using of medications for pain control or wearing of occlusal splint.

  2. Clinical conditions such as pregnancy. 3. Medical problems that may interfere with the procedures such as bleeding disorders, trigeminal neuralgia.

  4. Recent facial or neck trauma; medication or adjunctive treatment (eg, physiotherapy) that could not be stopped during the study; or allergy to local anesthetic solutions.

  5. Cognitive impairment or exhibited inadequate cooperation.

Primary outcomes:
measure: Patients' subjective pain experience
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00756210: Lifestyle and Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: University College of Antwerp
Sponsor class: OTHER
First posted: 2008-09-22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes

Brief summary: The objective of this trial is to determine the effect of different lifestyle interventions such as aerobic exercise and alternative resistance training methods, combined with a hypocaloric diet, on weight, body composition and metabolic risk factors in overweight and obese adults.


Eligibility criteria: Inclusion Criteria:

* Body mass index \> 24.9 kg/m²
* age \> 18 y
* pre-menopauzal

Exclusion Criteria:

* Body mass index \> 40 kg/m²
* Pregnancy
* Diabetes
* Joint replacement surgery

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Antwerp University Hospital
state: Antwerp
Study officials:
References:
Clinical trial NCT03273010: The Use of Cyanoacrylate on Palatal Wound
Official title: The Efficacy of Cyanoacrylate on Palatal Wound Healing and Postoperative Complaints
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Recession
Lead sponsor: T.C. ORDU ÜNİVERSİTESİ
Sponsor class: OTHER
First posted: 2017-09-06
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The palatal donor site of autogenous free gingival grafts significantly influences the patient's morbidity. The purpose of this study was to evaluate the efficacy of cyanoacrylate on palatal wound healing and postoperative complaints.

Detailed description: A total of 35 patients were included in the study. In the test group (19 patient), cyanoacrylate was placed over the palatal wounds; conversely, the 16 control group patients were allowed to heal in a conventional way without cyanoacrylate.

Primary bleeding time, presence of secondary bleeding, postoperative pain and completion of epithelization were assessed following free gingival graft operation. As a result, compared to the control group it was determined that the cyanoacrylate tissue adhesive could reduce the postoperative morbidity and improve the wound healing.

Eligibility criteria: Inclusion Criteria:

* no systemic diseases
* no coagulation disorders
* no drug intake in the previous 6 months that might effect the periodontal health status
* no pregnancy or lactation
* no smoking habit
* \<1 mm attached gingiva width on one or two lower anterior teeth
* Miller Class I- II- III (Miller 1985) with deep gingival recession (˃ 3mm)

Exclusion Criteria:

* Hematologic disorders
* No cooperation

Primary outcomes:
measure: Primary bleeding time
timeFrame: baseline
Secondary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: 1-7 days after operation
measure: Analgesic consumption
timeFrame: 1-7 days after operation
measure: Completion of epithelization
timeFrame: Once a week for a month after the operation
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06529510: REThinkWELL- the Use of Therapeutic Game to Reduce Mental Health Symptoms in Children and Adolescents
Official title: REThinkWELL- the Use of Therapeutic Game to Reduce Mental Health Symptoms in Children and Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emotional Problem
Mental Health Issue
Keywords: online therapeutic game
game-based CBT
emotional problems
mental health
children and adolescents
Lead sponsor: Babes-Bolyai University
Sponsor class: OTHER
Collaborators: name: The Executive Agency for Higher Education, Research, Development and Innovation Funding
First posted: 2024-07-31
Enrollment: 279
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To test the effect of a game-based intervention in reducing clinical and subclinical symptoms of children and adolescents.

Detailed description: The general objective of the study is to test the REThink therapeutic game for improvements in clinical and subclinical mental health symptoms in children and adolescents aged 8-16 years old from multiple schools and counties. The game will be used by children and adolescents from the experimental group for a period of four weeks. Pre-test and post-test measurements will be taken.

Eligibility criteria: Inclusion Criteria:

* children and adolescents aged 8 to 16 years
* subclinical level on the SDQ measure, total score, or emotional symptoms
* parental consent provided

Exclusion Criteria:

* intellectual disability or physical limitations precluding the use of the online game
* does not have parental informed consent

Primary outcomes:
measure: Mental health
timeFrame: baseline assessment, one week prior to the intervention
measure: Changes in mental health
timeFrame: post-test assessment, one week after the intervention
measure: Irrationality
timeFrame: baseline assessment, one week prior to the intervention
measure: Changes in irrationality
timeFrame: post-test assessment, one week after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Cluj-Napoca
country: Romania
facility: Babes-Bolyai University
Study officials:
References:
Clinical trial NCT05359510: The Use of Different Types of Mesh for Prevention of Incisional Hernia Versus Primary Abdominal Suturing
Official title: The Use of Different Types of Mesh at Different Sites in the Prevention of Incisional Hernia After Various Abdominal Incision Versus Primary Abdominal Suturing.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Incisional Hernia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-05-04
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The use of different types of mesh at different sites in prevention of incisional hernia after various abdominal incision versus primary abdominal suturing.

Detailed description: The burden of incisional hernia after abdominal exploration has raised the question if a prophylactic mesh placement during abdominal wall closure is of benefit.

The reported rate of incisional hernia after abdominal incisions varies from 4.2% up to a calculated risk of 73%. The impact on quality of life and annual health care costs has motivated various groups to research ways to decrease the rate of incisional hernia by optimizing the technique of abdominal wall closure.

One of the crucial risk factors of the genesis of incisional hernias is the malfunction of collagen synthesis. Other main risk factors are found to be obesity, steroid therapy, malnutrition, nicotine abuse, and other connective tissue diseases.

Since German physician Theodor Billroth's first suggested use of prosthetic material to close the hernia defect in 1890, continued interest lead to the development of a variety of surgical meshes and techniques for suture and mesh reinforcement to prevent incisional hernia . Overtime, RCTs have demonstrated the effectiveness of the use of prophylactic mesh in the prevention of incisional hernia. While surgeons world over use different techniques of positioning mesh in the prophylactic mesh repair (PMR) such as the Onlay, Sublay and Intraperitoneal positions, which can be associated with a high incidence of complications such as the postoperative seroma.

Eligibility criteria: Inclusion Criteria:

* informed consent
* patient age: ≥ 18 years
* patients undergoing elective or urgent open abdominal surgical procedure regardless of benign or malignant disease

Exclusion Criteria:

* age \<18 years
* navel site infection
* pregnancy
* expected survival \<12 month
* previous intra abdominal mesh placement

Primary outcomes:
measure: early wound complications
timeFrame: 1 month
measure: late wound complications
timeFrame: 1 month
Secondary outcomes:
measure: complication rate
timeFrame: intraoperative complications will be recorded immediately after finishing the operation
measure: incidence of incisional hernia
timeFrame: 12 month
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
affiliation: general surgery Assiut universitiy
name: Mostafa Abdel Aziz
role: STUDY_CHAIR
References:
Clinical trial NCT03137810: Placental Cord Drainage Versus no Placental Drainage in the Management of Third Stage of Labour
Official title: Placental Cord Drainage Versus no Placental Drainage in the Management of Third Stage of Labour: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obstetric Delivery
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2017-05-03
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this work is to compare the effectiveness of placental cord drainage with no drainage in reducing the duration and blood loss in 3rd stage of labour.


Eligibility criteria: Inclusion Criteria:

* Full term Uncomplicated singleton pregnancy Pregnancy with vertex presentation Patients expected to have spontaneous vaginal delivery

Exclusion Criteria:

* Over distended uterus(hydramnios.large fetus) Previous history of postpartum haemorrhage Known coagulation disorder Haemoglobin less than 8 g/dl Ante partum haemorrhage Multiple pregnancies Instrumental delivery

Primary outcomes:
measure: Duration of the third stage of labour
timeFrame: within 15 min of delivery of baby
Secondary outcomes:
measure: Amount of blood loss
timeFrame: FIRST 24 HOURS
measure: retained placenta
timeFrame: 1ST HOUR OF DELIVERY
measure: Manual removal of placenta
timeFrame: 1HOUR OF DELIVERY
measure: Changes in maternal haematocrit (Hct) after birth
timeFrame: 1ST 24 HOURS
measure: blood transfusion
timeFrame: 1ST 24 HOURS
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain shams university maternity hospital
Study officials:
affiliation: Ain Shams University
name: Hassan A Bayoumy, MD
role: STUDY_CHAIR
affiliation: Ain Shams University
name: Amgad E Abou-Gamrah, MD
role: STUDY_DIRECTOR
References: