louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00160420: A Long-Term Study to Evaluate the Safety of Asoprisnil in the Treatment of Women With Endometriosis From Study M01-398
Official title: A Phase 2, 12-Month, Open Label Extension Study to Evaluate the Safety of J867(5 mg QD) in Subjects With Endometriosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Endometriosis
Keywords: Pelvic pain
Dysmenorrhea
Dyspareunia
Infertility
asoprisnil
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 73
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to determine the long-term safety of asoprisnil 5 mg for 12 months in women with endometriosis from study M01-398.

Detailed description: Endometriosis, the presence of endometrial tissue outside the uterus, is a progressive, estrogen-dependent disease that occurs in menstruating women of reproductive age. Although all major endometriosis therapies are effective for the treatment of pain, no single treatment is superior to others in terms of efficacy. The major drawbacks of the current medical therapies are severe side effects such as hot flushes and osteoporosis. The objective of this study is to determine the long-term safety of asoprisnil 5 mg daily for 12 months in women with endometriosis, after an initial 12 weeks in study M01-398. The safety will be based on assessments of the endometrium, lipid profiles, adverse events, and changes from baseline laboratory values and vital signs.

Eligibility criteria: Inclusion Criteria:

* Completed 3 months of dosing and Month 3 procedures in study M01-398
* Otherwise in good health
* Month 3 (M01-398) ultrasound reveals no significant gynecologic disorder

Exclusion Criteria:

* Any abnormal lab or procedure result the study-doctor considers important
* Anticipated need for excluded hormonal therapy or unapproved narcotics

Primary outcomes:
measure: Change from baseline in pelvic pain and dysmenorrhea assessed by visual analog scale.
timeFrame: Months 1,3,6,9,12 and final visit
measure: Change from baseline in pelvic pain, dysmenorrhea, dyspareunia, pelvic tenderness and induration assessed by modified Biberoglu and Behrman grading scale.
timeFrame: Months 3,6,9,12 and final visit
Secondary outcomes:
measure: Percentage of subjects with amenorrhea.
timeFrame: Throught treatment period.
Other outcomes:
Locations:
Study officials:
affiliation: Abbott
name: Medical Director
role: STUDY_CHAIR
References:
Clinical trial NCT05769920: Dose Escalation TTHX1114 Ophthalmic Solution
Official title: A Phase 1 Dose-Escalation Study Evaluating the Safety, Tolerability, and Pharmacokinetics of TTHX1114(NM141) Ophthalmic Solution In Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Corneal Epithelial Degeneration
Lead sponsor: Trefoil Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2023-03-15
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: Dose escalation 3+3 design with accelerated titration 4 dose levels

Detailed description: This is a 28-day open-label dose-escalation study. TTHX1114(NM141) Ophthalmic Solution: 1 drop (gtt) to the Study Eye (SE) twice daily for a total of 7 days. Four planed dose levels, accelerated titration DL1 and DL2, standard 3+3 design.

Eligibility criteria: Inclusion Criteria:

* Female or male, 18 to 65 years of age, Female subjects of child-bearing potential must be non-pregnant
* Able to provide voluntary written informed consent
* Normal ocular function (BCVA 20/20) and anatomy
* Available for and agree to all study procedures including inpatient monitoring, follow-up visits, sample collection, study treatment administration
* Body mass index 18.5 to 35 kg/m\^2
* Demonstrated ability to self-administer eye drops

Exclusion Criteria:

* Clinically significant co-morbid ocular conditions
* Co-morbid medical conditions requiring treatment
* Active ocular infection within the 2 weeks prior to Day 1
* Active non-ocular infection requiring antibiotics within the 2 weeks prior to Day 1
* Use of systemic or dermatological cytotoxic chemotherapy within the 1 month prior to Day 1
* Planned contact lens use during the study period
* Use of any investigational product within the 1 month prior to Day 1
* Corticosteroid use in the 1 month prior to Day 1
* Major surgery within the 3 months prior to Day 1
* History of dependence on alcohol or drugs of abuse
* History of intolerance, hypersensitivity, or significant allergy to any drug compound, food, or other substance
* Any other reason (e.g., serious systemic disease or uncontrolled medical condition) that, in the opinion of the Investigator could increase the subject's risk, interfere with the interpretation of the study results, or affect the subject's ability to provide informed consent or comply with the study

Primary outcomes:
measure: Dose Limiting Toxicity
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Cypress
country: United States
facility: Trefoil Clinical Site #132
state: California
Study officials:
affiliation: Trefoil Therapeutics.com
name: Thomas Tremblay
role: STUDY_DIRECTOR
References:
Clinical trial NCT01382420: Long-term Beneficial Metabolic Effects of Adrenalectomy in Subclinical Cushing's Syndrome of Adrenal Incidentaloma
Official title: Long-term Effects of Adrenalectomy on Metabolic Syndrome, Glucose Metabolism, Lipid Metabolism, and Bone Metabolism in Subclinical Cushing's Syndrome of Adrenal Incidentaloma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cushing Syndrome
Keywords: subclinical cushing syndrome
hypercortisolism
adrenal incidentaloma
adrenalectomy
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Asan Medical Center
name: Severance Hospital
name: Konkuk University Medical Center
First posted: 2011-06-27
Enrollment: 234
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective:

To determine the metabolic effects of the adrenalectomy in subclinical Cushing's syndrome of adrenal incidentaloma.

Methods:

234 subclinical cushing syndrome and adrenal incidentaloma will be randomly assigned into two groups(e.g adrenalectomy group and conservative treatment group).


Eligibility criteria: Inclusion Criteria:

* patients with both unilateral adrenal incidentaloma and hypercortisolism
* definition of hypercortisolism

  * overnight dexamethasone suppression test, serum cortisol\>1.8ug/dL
  * 24hr urine cortisol \> upper reference limit

Exclusion Criteria:

* patients who took medication influencing cortisol secretion
* patients with definite clinical feature of cushing syndrome

  * moon face
  * abdominal striae
  * skin or proximal muscle atrophy
* metabolic syndrome, hyperthyroidism, hyperparathyroidism, chronic renal failure, rheumatic disease, hematologic disease
* patients who took following medication

  * insulin
  * oral hypoglycemic agent
  * thyroid hormone
  * anti-hyperlipidemic drug
  * sex hormone
* patients who taking steroid hormone or who took steroid hormone more than 2 weeks within 1 year
* psychiatric disease

Primary outcomes:
measure: Change of lipid profile between two groups
timeFrame: 4 Year
Secondary outcomes:
measure: Incidence of obesity between two groups
timeFrame: 4Year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Jae Hyeon Kim
role: STUDY_DIRECTOR
affiliation: M.D, Ph.D
name: Jung-Min Koh
role: STUDY_CHAIR
affiliation: M.D, Ph.D.
name: Kee-Ho Song
role: PRINCIPAL_INVESTIGATOR
affiliation: M.D, Ph.D.
name: Yumie Rhee
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05256420: Effect of Kinesiotape on Postural Control in Non-operated Anterior Cruciate Ligament Subjects
Official title: Effect of Kinesiotape on Postural Control in Subjects With Non-operated Anterior Cruciate Ligament (ACL) Injuries: a Randomized, Double-blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Injuries
Cruciate Ligament Rupture
Anterior Cruciate Ligament Injuries
Motor Control
Balance
Lead sponsor: Universidad Rey Juan Carlos
Sponsor class: OTHER
First posted: 2022-02-25
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Anterior cruciate ligament (ACL) injuries are the most common traumatic knee ligament injuries. This lesion has a devastating influence on patients' activity levels and quality of life. ACL injuries are most frequent between the ages of 15 and 45 years. Individuals who choose conservative treatment must undergo physical therapy to strengthen muscles around the knee, notably the quadriceps femoris and hamstring muscles. It had been described that in absence of surgical treatment, the knee remains unstable and vulnerable to injury having a much poorer prognosis. This study aims to analyze the effectiveness of neuromuscular taping (kinesiotape) compared to placebo in patients with non-operated anterior cruciate ligament rupture.


Eligibility criteria: Inclusion Criteria:

* Patients of both sexes, diagnosed with ACL rupture (clinical and imaging) between 18 and 60 years old and not yet operated.
* Rupture isolated or combined with meniscopathy including bucket-handle.
* Partial or complete ACL rupture.

Exclusion Criteria:

* Cognitive impairment that prevents understanding of simple commands.
* Unhealed wounds in the knee complex.
* Severe skin diseases and alterations.
* Previous history of allergy to any type of bandage.
* Neurological disease with impaired balance.
* Manifest deformity of the musculoskeletal system

Primary outcomes:
measure: Motor Control Test (MCT)
timeFrame: 10 minutes
measure: Unilateral Stance (US).
timeFrame: 10 minutes
measure: Star Excursión Balance Test (SEBT).
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Alcorcón
country: Spain
facility: Universidad Rey Juan Carlos
state: Madrid
Study officials:
References:
Clinical trial NCT06821620: Interaction of MTNR1B Genotype and Type of Breakfast (Protein-enriched v Carbohydrate-rich) on Postprandial Glucose Response.
Official title: Interaction of MTNR1B Genotype and Type of Breakfast (Protein-enriched v Carbohydrate-rich) on Postprandial Glucose Response.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glucose Metabolism Disorders
Lead sponsor: St. Mary's University, Twickenham
Sponsor class: OTHER
First posted: 2025-02-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The risk version of the MTNR1B gene (which codes for a melatonin receptor) has been associated with type II diabetes (T2D) and associated physiological markers. People with the risk version of the gene have reduced secretion of insulin when melatonin levels are high (between evening and morning) and impaired glucose tolerance when they eat late. Previous research suggests eating a protein enriched breakfast can improve glucose response. Therefore, the present study will investigate if the version of the MTNR1B gene that people have is associated with their glucose response after breakfast. Also, whether a protein enriched breakfast improves glucose response in participants with the risk version of the gene. Measures of glucose response collected over the two-week duration of the study will be compared between groups with the different versions of the gene. These findings can be used to provide personalised nutrition advice which may reduce the risk of T2D.


Eligibility criteria: Inclusion Criteria:

* aged 18-48 years\*, not diabetic, not sleep disorder, not relevant medication (weight loss, sleeping, melatonin), not restricted diet, not allergic to oats, milk, wheat, barley or soya, not implanted medical device, such as pacemakers.

Exclusion Criteria:

* aged \< 18 or \> 48 years, diabetic, sleep disorder, eating disorder, taking relevant medication (weight loss, sleeping, melatonin), following a restricted diet, implanted medical device, such as pacemakers.

Primary outcomes:
measure: Glucose response
timeFrame: 120 minutes
Secondary outcomes:
measure: CGM metrics - mean glucose
timeFrame: 14 days
measure: CGM metrics - Time in range
timeFrame: 14 days
measure: CGM metrics - glycaemic variability
timeFrame: 14 days
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St Mary's University
Study officials:
References:
Clinical trial NCT02539420: A Prospective Trial of BiPAP Administration vs. Non-positive Pressure Therapy for Pediatric Status Asthmaticus
Official title: A Prospective, Randomized Trial of Early Versus Delayed BiPAP Administration or Non-positive Pressure Therapy in the Management of Pediatric Status Asthmaticus
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Status Asthmaticus
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: Feinstein Institute for Medical Research
First posted: 2015-09-03
Enrollment: 0
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Though BiPAP is an increasingly common tool used by pediatric critical care physicians and there is promising data suggesting a role for BiPAP in the management of status asthmaticus, more information is needed to more definitively clarify the extent of its benefit, as well as when during an asthma exacerbation and in whom it is the most beneficial. In this study, which is among the first randomized studies of BiPAP use for status asthmaticus in the pediatric population, the investigators hope to better elucidate these issues to help guide clinicians' future management decisions.


Eligibility criteria: Inclusion Criteria:

* Primary diagnosis of asthma exacerbation
* Admitted to Cohen Children's Medical Center (CCMC) PICU
* CCMC respiratory severity score of 6 or higher at the time of enrollment
* Prior history of asthma or reactive airway disease

Exclusion Criteria:

* No prior history of asthma or reactive airway disease
* Facial or airway anomalies precluding BiPAP mask use
* Tracheostomy
* Lack of airway protective reflexes
* Neurologic or musculoskeletal abnormalities affecting respiration
* Underlying cardiovascular problems that may be negatively affected by positive pressure ventilation
* Intracranial problems (such as in the setting of head injury) that may be negatively affected by positive pressure ventilation
* Respiratory compromise for which emergent endotracheal intubation or non-invasive positive pressure ventilation is warranted as determined by the on-service attending physician

Primary outcomes:
measure: Clinical Asthma Scores
timeFrame: 3 hours after enrollment
Secondary outcomes:
measure: Dyspnea Scores
timeFrame: 0 hours, 3 hours, 6 hours, 9 hours, 12 hours, 24 hours, and 36 hours after enrollment
measure: BiPAP Tolerance
timeFrame: Hospitalization
measure: Length of stay in intensive care unit (ICU)
timeFrame: ICU stay -- Expected to be approximately 3 days on average
measure: Length of stay in hospital
timeFrame: Hospital length of stay -- Expected to be approximately 5 days on average
measure: Side effects or adverse events
timeFrame: Hospitalization
measure: Clinical Asthma Scores
timeFrame: 0 hours, 6 hours, 9 hours, 12 hours, 24 hours, and 36 hours after enrollment
Other outcomes:
Locations:
Study officials:
affiliation: Cohen Children's Medical Center
name: Sandeep Gangadharan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00563420: Early Lung Cancer Detection in Patients With Sputum Cytology and Autofluorescence Bronchoscopy in People at High Risk of Lung Cancer
Official title: Early Lung Cancer Detection in Patients With Sputum Cytology and Autofluorescence Bronchoscopy in People at High Risk of Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Neoplasms
Keywords: Lung cancer
Lead sponsor: Hospital Authority, Hong Kong
Sponsor class: OTHER_GOV
First posted: 2007-11-26
Enrollment: 400
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Primary purpose: DIAGNOSTIC

Brief summary: Lung cancer is the commonest malignant disease with a 5-year survival of 14%. In Hong Kong, it accounts for about 30% of all cancer death. The poor prognosis of lung cancer is due largely to the late clinical presentation of the disease. In order to improve the prognosis of lung cancer, an obvious approach is to develop sensitive methods for detecting lung cancer at much earlier stages when treatment is more likely to be curative.

However, the best way for identifying early lung cancer is still need to be determined. We hypothesis that by examining specimens that contain shed bronchial epithelial cells i.e. sputum, lung cancer can be sampled in its earliest possible phase. And by using autofluorescence bronchoscopy, a system specifically designed to detect early lung cancer/pre-invasive lesions, to identify the source of abnormal cells, we may able to detect eraly lung cancer and followed by curative treatment to improve the prognosis of this disease.


Eligibility criteria: Inclusion Criteria:

* Current or ex-smokers who have smoked at least 20-pack-years (e.g. 1 pack per day for 20 years or more)
* Informed consent

Exclusion Criteria:

* Known malignant disease
* Unstable major medical disease
* Bleeding disorder
* Unwilling to have a bronchoscopy
* Women currently pregnant or nursing
* Known reaction to xylocaine, a local anaesthesia agent used for bronchoscopy

Primary outcomes:
measure: Number of early stage lung cancer/precancerous lesion detected
timeFrame: Two years
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Queen Mary Hospital
Study officials:
affiliation: Department of Medicine, Queen Mary Hospital/ The University of Hong Kong
name: Bing Lam, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03293420: Retrospective Analysis of a Population of Patients With With Severe Traumatic Head Injury and Woken Early
Official title: Retrospective Analysis of a Population of Patients With With Severe Traumatic Head Injury and Woken Early
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Traumatic Head Injury
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2017-09-26
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with traumatic head injury

Brief summary: Observational retrospective study that included all patients meeting the inclusion criteria from 1st January 2014 to 31st December 2015.

The objective of the study is to describe and compare two populations of patients with severe traumatic head injury arriving under sedation in the Department in whom the sedation was not continued.


Eligibility criteria: Inclusion Criteria:

- Patients with traumatic head injuring arriving in the Neurosurgery and Traumatologic Intensive Care Unit under sedation

Exclusion Criteria:

* Brain death within the 48h following admission,
* Stroke leading to the traumatic head injury,
* Death within the 24h following admission,
* Patients not under sedation on admission to the unit,
* Non-sedated patients transferred directly to the operating theatre
* Traumatic brain injury in patients presenting chronic sub-dural haematoma,
* Continued sedation (\> 15h) in the ICU.

Primary outcomes:
measure: Motor score
timeFrame: At baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon Bourgogne
Study officials:
References:
Clinical trial NCT02292420: The Normal Reference Values of Pulse Oximetry Plethymographic Waveform Parameters
Official title: The Normal Reference Values of Pulse Oximetry Plethymographic Waveform Parameters
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulse Oximetry Plethymographic Waveform
Area Under Curve
Amplitude
Keywords: pulse oximetry plethymographic waveform
area under curve
amplitude
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2014-11-17
Enrollment: 1019
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: community sample

Brief summary: The purpose of this study is to determine the normal reference values of pulse oximetry plethymographic waveform parameters in Chinese population.


Eligibility criteria: Inclusion Criteria:

Healty adults; Comply with ethical requirements and signed informed consent.

Exclusion Criteria:

Leuconychia; Stained fingernails; Diseases that have an impact on the blood flow of the peripheral tissue (such as Raynaud's phenomenon, vasculitis and so on); Any conditions the study physicians believe not suitable for inclusion.

Primary outcomes:
measure: parameters of pulse oximetry plethymographic waveform
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Xuezhong Yu, MD
role: STUDY_DIRECTOR
References: