louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00759421: Exploratory Cognition Study of Sertindole in Patients With Schizophrenia
Official title: An Exploratory Cognition Study Conducted as an add-on to Clinical Trial 11286, to Evaluate the Neurocognitive Effects of 12 Weeks Treatment With Sertindole and Olanzapine in Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Keywords: Schizophrenia
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2008-09-25
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this exploratory study is to evaluate the effects of sertindole and olanzapine on neurocognitive functioning in patients with schizophrenia.

Detailed description: Cognitive deficits, including impairments in areas such as memory, attention, and executive function, are major determinants and predictors of long-term disability in schizophrenia. At present, available antipsychotic medications are relatively ineffective in improving cognition. However, scientific discoveries during the past decade suggest that it may be possible to develop medications that are effective in improving cognition in schizophrenia.

One of the important reasons to focus on cognitive deficits as a target for pharmacological treatment, is the association found between cognitive impairment and social dysfunction observed in patients with schizophrenia. Pervasive cognitive deficits have a limiting effect on the quality of life of patients with schizophrenia including social interaction and problem solving, community living, and employment prospects.

Eligibility criteria: Inclusion Criteria:

* Patients with schizophrenia
* Participation in 11286 study
* Capable of completing all study-related psychometric activities for the duration of the study

Primary outcomes:
measure: Global cognitive composite score
timeFrame: 12 weeks
Secondary outcomes:
measure: Cognitive performance in the following domains: 1) Working memory; 2) Attention and vigilance; 3) Verbal learning and memory; 4) Visual learning and memory; 5) Reasoning and problem solving; 6) Speed of processing
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Tapei
country: Taiwan
facility: TWN001
Study officials:
affiliation: LundbeckClinicalTrials@lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References:
Clinical trial NCT03055221: TRUST-2: Safety and Efficacy of Intravenous Remodulin® in Patients in India With Pulmonary Arterial Hypertension (PAH)
Official title: TRUST-2: An Open-label Continuation Trial of the Safety and Efficacy of Intravenous Remodulin® in Patients in India With Pulmonary Arterial Hypertension (PAH)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pulmonary Arterial Hypertension
Keywords: Remodulin
6-Minute Walk Test
Lead sponsor: United Therapeutics
Sponsor class: INDUSTRY
First posted: 2017-02-16
Enrollment: 20
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This was an open-label extension of Study RIV-PH-402, TRUST-1: Treprostinil for Untreated Symptomatic Pulmonary Arterial Hypertension (PAH) Trial. Subjects who completed Study RIV-PH-402 were eligible to enroll.


Eligibility criteria: Inclusion Criteria:

* Subjects who were enrolled in and completed Study RIV-PH-402 (TRUST-1)

Exclusion Criteria:

* Subjects who were unblinded for potential rescue therapy in Study RIV-PH-402 and were found to be allocated to the Remodulin treatment group were not eligible to participate in this study.

Primary outcomes:
measure: Effect of Long-term Remodulin Therapy on the 6-Minute Walk Distance (6MWD)
timeFrame: The 6MWD was assessed at each subject's last visit, which occurred up to approximately 9 years after first visit
measure: Effect of Long-term Remodulin Therapy on the NYHA Functional Classification
timeFrame: The NYHA functional classification was assessed at each subject's last visit, which occurred up to approximately 9 years after first visit
measure: Effect of Long-term Remodulin Therapy on Subject Safety
timeFrame: Baseline to Week 12
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04043221: Long Term Metformin in Women With Polycystic Ovary Syndrome
Official title: Effects of Long Term Treatment With Metformin on Clinical, Metabolic and Endocrine Parameters in Women With Polycystic Ovary Syndrome And Increased Metabolic Risk
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polycystic Ovary Syndrome
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2019-08-02
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Collection data from endocrine outpatient clinic for 10 years of women with PCOS phenotype A, BMI≥ 25kg/m2, all receiving monotherapy with metformin 1000 mg twice a day.

Brief summary: The investigators analyzed collection data of 10 years for the efficacy of metformin on body mass, menstrual frequencies, metabolic and hormonal outcomes in women with polycystic ovary syndrome (PCOS) and BMI ≥ 25kg/m2.

Each patient's age and height were recorded at baseline. In addition each patient weight, waist circumference, menstrual regularity, fasting glucose, glucose after 120 minute oral glucose tolerance test, luteinizing hormone, follicle stimulating hormone , free and direct testosterone, androstenedione, sex hormone binding globulin, dehydroepiandrosterone sulfate were identified at baseline and at the every follow up visit where available.


Eligibility criteria: Inclusion Criteria:

* PCOS phenotype A
* BMI≥ 25kg/m2
* metformin 1000mg twice a day for at least one year

Exclusion Criteria:

* PCOS phenotype B, C, D
* BMI \<25kg/m2
* had been treated with spironolactone or oral contraceptives alone or in combination with metformin
* had history of bariatric surgery
* became pregnant during the observation period
* had inability to tolerate metformin, leading to the cessation of drug therapy within first follow up year

Primary outcomes:
measure: body weight
timeFrame: The measurement is assessed in kilograms at the beginning and after every year of taking metformin for 10 years.
measure: menstrual frequency
timeFrame: The measurement is assessed in number of bleeds per year at the beginning and after every year of taking metformin for 10 years.
measure: free testosterone
timeFrame: The measurement is assessed in nmol/L at the beginning and after every year of taking metformin for 10 years.
measure: diabetes mellitus
timeFrame: The measurement of glucose in blood is assessed in mmol/L at the beginning and after every year of taking metformin for 10 years.
Secondary outcomes:
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: University Medical Center Ljubljana
Study officials:
References:
Clinical trial NCT03282721: Transverse Facial Cleft Repair Using Precise Location of Commissure
Official title: Transverse Facial Cleft (Macrostomia) Repair: Modification of a Traditional Technique
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Transverse Facial Cleft
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2017-09-14
Enrollment: 9
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with transverse facial cleft who hadn't receive any treatment.

Brief summary: To compare the effect of redesigned transverse facial cleft treatment and traditional transverse facial cleft treatment.

Detailed description: Nine patients with transverse facial cleft were treated with redesigned repair using precise location of commissure. The main outcome measurement included scar, symmetry of the commissure. They were graded in five scores by five resident physicians who had never seen the patients. The results were compared with healthy controls.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of transverse facial cleft disease;
* Must not received any lip surgeries before;
* Such disease can be accompanied by external ear abnormalities, hypoplastic mandible, cleft lip and palate.

Exclusion Criteria:

* Severe general diseases;
* Patients who had been treated with lip surgery;
* Patients and/or his/her family didn't want to continue the clinical trial.

Primary outcomes:
measure: Scar of the repaired commissures
timeFrame: 6 to 12 months after surgery
measure: symmetry of the commissures
timeFrame: 6 to 12 months after surgery
Secondary outcomes:
measure: scar of the repaired commissures
timeFrame: immediately after surgery
measure: symmetry of the commissures
timeFrame: immediately after surgery
measure: scar of the repaired commissures
timeFrame: 1 to 6 months after surgery
measure: symmetry of the commissures
timeFrame: 1 to 6 months after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Peking Union Medical College Hospital
name: LIAN ZHOU, D.D.S
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01692821: Effect of Systemic Hypoxia and Hyperoxia on Retinal Oxygen Saturation
Official title: Effect of Systemic Hypoxia and Hyperoxia on Retinal Oxygen Saturation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Retinal Oxygenation
Retinal Blood Flow
Keywords: retinal oxygen saturation
retinal blood flow
hyperoxia
hypoxia
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2012-09-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Adequate perfusion and oxygenation is essential for the function of the inner retina. Although it is known that oxygen tension is very well autoregulated in the retina, the physiological mechanisms behind this regulation process are not fully explored. The development of new instruments for the non-invasive measurement of oxygen tension in retinal vessels now allows for the more precise investigation of these physiological processes. The current study seeks to evaluate the retinal oxygen saturation in healthy subjects while breathing different oxygen mixtures to achieve a hypoxic and a hyperoxic state.


Eligibility criteria: Inclusion Criteria:

* Men and women aged between 18 and 35 years
* Nonsmokers
* Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
* Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant
* Normal ophthalmic findings, ametropy \< 3 Dpt.

Exclusion Criteria:

* Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study (except oral contraceptive)
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* Presence of any form of anemia
* Blood donation during the previous 3 weeks
* Pregnancy

Primary outcomes:
measure: Retinal oxygen saturation
timeFrame: On the study day - during each breathing period (6 times)
Secondary outcomes:
measure: Retinal blood flow
timeFrame: On the study day - during each breathing period (6 times)
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna, Department of Clinical Pharmacology
Study officials:
affiliation: Department of Clinical Pharmacology, Medical University of Vienna
name: Gerhard Garhöfer, Assoc. Prof. Priv.-Doz. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Palkovits S, Lasta M, Told R, Schmidl D, Boltz A, Napora KJ, Werkmeister RM, Popa-Cherecheanu A, Garhofer G, Schmetterer L. Retinal oxygen metabolism during normoxia and hyperoxia in healthy subjects. Invest Ophthalmol Vis Sci. 2014 Jul 11;55(8):4707-13. doi: 10.1167/iovs.14-14593.
Clinical trial NCT03209921: Pharmacokinetic Variability of Daptomycin During Prolonged Therapy for Bone and Joint Infections
Official title: Pharmacokinetic Variability of Daptomycin During Prolonged Therapy for Bone and Joint Infections
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bone and Joint Infection
Patient Treated by Daptomycin
Keywords: Bone and Joint Infection
Daptomycin
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-07-06
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with daptomycin for BJI in Lyon Center in 2012 and 2013

Brief summary: Daptomycin is a cyclic lipopeptide that has been proposed as an alternative therapeutic option in patients with prosthetic joint infection caused by Staphylococcus or Enterococcus species in the latest Infectious Diseases Society of America (IDSA) guidelines.

The population pharmacokinetics (PK) of daptomycin have been described in various groups of patients in previous publications. However, little information exists on the PK of daptomycin in patients with bone and joint infections (BJI). Also, previous population studies did not investigate daptomycin PK over prolonged therapy, and, to our knowledge, no study has reported the intraindividual PK variability of this drug.

The aim of this study is to describe the inter- and intraindividual PK variability of this drug.


Eligibility criteria: Inclusion Criteria:

* patients treated with daptomycin for BJI in Lyon Center in 2012 and 2013

Exclusion Criteria:

-

Primary outcomes:
measure: Typical daptomycin clearance
timeFrame: 6 months
measure: Typical daptomycin volume of distribution
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05825521: Impact of Cerebral Ventricular Dilatations and Cerebrospinal Fluid Pulsations on Periventricular White Matter in Hydrocephalic Patients
Official title: Impact of Cerebral Ventricular Dilatations and Cerebrospinal Fluid Pulsations on Periventricular White Matter in Hydrocephalic Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hydrocephalus
Cerebral Ventricle
Cerebrospinal Fluid
White Matter Fiber
Keywords: Hydrocephalus
cerebral ventricles
cerebrospinal fluid
white matter fibers
functional biomarkers
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2023-04-24
Enrollment: 80
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Hydrocephalus is characterized by excessive accumulation of cerebrospinal fluid (CSF) in the ventricles of the brain. One of the forms of hydrocephalus is called "normal pressure", although one of the main signs is precisely an alteration of the intracranial pressure (ICP), it is here called active hydrocephalus (HA). Although MRI is the reference radiological modality for the characterization of HA. The Evan's and DESH index are radiological diagnostic criteria based on the dilation and morphology of the CSF compartments. These morphological indices remain insensitive and specific. In recent years, advances in Phase Contrast (MRI-PC) and Diffusion (MRI-DTI) MRI have generated new biomarkers of brain viability. The aim of this study is to characterize by MRI the impact of hydrocephalus on brain fluids and tissues.


Eligibility criteria: Inclusion Criteria:

* For Patients with hydrocephalus:
* Age \> 55,
* Ventricular dilation: Evans Index \> 0.3;
* Patients with cognitive impairment, and gait disturbances and/or urinary incontinence or a combination of these three symptoms;
* Absence of other neurological diseases that could cause ventriculomegaly, information and non-opposition.
* For Controls:
* Age ≥ 55;
* No ventricular dilation: Evans Index \< 0.3;
* Individuals who have no neurological or psychiatric disease;
* No neurological deficit.
* No history of neurosurgery or head trauma;
* signed informed consent;
* affiliation to a social security scheme.

Exclusion Criteria:

* All patients who have a neurological disease other than active hydrocephalus will be excluded;
* Individuals unable to sign or understand consent;
* Individuals with psychiatric, neurological or medical development;
* Individuals under treatment with psychoactive drugs;
* Individuals who cannot tolerate an MRI examination;
* Any individual with implant, pacemaker, prosthesis and ferromagnetic object

Primary outcomes:
measure: Variation of MRI flow between both groups
timeFrame: 3 years
measure: Variation of MRI diffusion between both groups
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Salouël
country: France
facility: CHU Amiens
Study officials:
References:
Clinical trial NCT03583021: Sugammadex on Remifentanil Ce for Preventing Emergence Cough in Male
Official title: Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gallbladder Diseases
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2018-07-11
Enrollment: 42
Sex: MALE
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary purpose of this study is to investigate the optimal Ce of remifentanil for preventing emergence cough following extubation during general anesthesia in male patients who are reversed with sugammadex or neostigmine.

Detailed description: Remifentanil is a potent ultrashort-acting opioid, with rapid onset and offset of drug effect. It allows rapid anesthetic emergence even after a prolonged infusion, and decreases the at-risk time during extubation. In addition, cough suppression of remifentanil enables smooth extubation with reduced complications. However, the infusion of remifentanil suppresses the emergence cough effectively in clinical practice, whereas it still delays the awakening from anesthesia, resulting in prolonged emergence time. Reduced Ce of remifentanil during emergence would decrease the adverse events that are associated with remifentanil infusion.

Eligibility criteria: Inclusion Criteria:

* Laparoscopic cholecystectomy under general anesthesia

Exclusion Criteria:

* BMI \> 30 kg/m2, respiratory infection, uncontrolled hypertension

Primary outcomes:
measure: optimal Ce of remifentanil
timeFrame: from the ene of surgery until endotracheal extubation
Secondary outcomes:
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine
state: Seoul
Study officials:
affiliation: Ajou University School of Medicine
name: Ji Eun Kim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04756921: 18F-FDG Uptake Heterogeneity Predicts Pyrotinib Response
Official title: Pretreatment 18F-FDG Uptake Heterogeneity Predicts Response to Pyrotinib in Patients With Metastatic HER2-positive Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HER2-positive Breast Cancer
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2021-02-16
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with HER2 positive breast cancer with confirmed metastasis, regardless of being de novo diagnosed or progressed from a non-metastatic stage.

Brief summary: Heterogeneity of 18F-fluorodeoxyglucose (FDG) uptake is a promising marker for predicting response to treatment. This study aimed to evaluate the ability of pretreatment positron emission tomography/computed tomography (PET/CT) 18F-FDG-based heterogeneity to predict the response to pyrotinib in patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC).


Eligibility criteria: Inclusion Criteria:

* Pathologically confirmed HER2 positive breast cancer
* Treated with Pyrotinib in the metastatic settings
* Underwent whole-body FDG PET/CT within 4 weeks before the initiation of pyrotinib and capecitabine were included in this study

Exclusion Criteria:

* Incomplete medical history
* Loss of follow up

Primary outcomes:
measure: PFS
timeFrame: Through study completion, an expected average of 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
References: