louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00302770: Efficacy of Quetiapine in Generalised Social Anxiety Disorder
Official title: Efficacy of Quetiapine in Generalised Social Anxiety Disorder, a Double-blind, Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Social Anxiety Disorder
Keywords: Patients with SAD
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-03-15
Enrollment: 50
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: This trial will explore the efficacy of quetiapine in Social Anxiety Disorder, generalized type. The following elements of response will be tested: number of responders to treatment, time to response, effect size as measured with the LSAS


Eligibility criteria: Inclusion Criteria:

* Written Confirmed Consent,
* All patients meet the DSM IV criteria for generalized social anxiety disorder,
* A score ≥ 60 on the LSAS,
* male and female aged between 18 and 65 years

Exclusion Criteria:

* Presence of any primary axis I diagnosis other than social anxiety disorder according to DSM-IV,
* alcohol and/or substance abuse according to DSM-IV criteria within the last 12 months,
* any personality disorder as the primary diagnosis, with the exception of avoidant personality disorder,
* patients at risk of suicide

Primary outcomes:
measure: Change on Lebowitz Social Anxiety Scale (LSAS) from baseline to endpoint
Secondary outcomes:
measure: Number of responders, time to onset of response of sustained response to treatment
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Netherlands Medical Director, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05613270: Characterizing Breast Cancer With 18F-FES PET/CT
Official title: A Prospective Pilot Study to Explore Performance and Efficacy of 18F-FES PET/CT in ER-positive Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2022-11-14
Enrollment: 50
Sex: FEMALE
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: DIAGNOSTIC

Brief summary: 18F-fluoroestradiol (FES) is radioactive labeled estradiol, developed for in vivo visualization of estrogen receptor (ER) using positron emission tomography (PET). In this prospective study, 18F-FES PET/CT will be used to evaluate ER activity of metastatic disease and their potential sensitivity to endocrine therapy in ER-positive breast cancer.


Eligibility criteria: Inclusion Criteria:

* suspected or confirmed metastatic ER-positive breast cancer;
* 18F-FDG PET/CT within two weeks;
* signed written consent.

Exclusion Criteria:

* pregnancy;
* breastfeeding;
* any medical condition that in the opinion of the investigator may significantly interfere with study compliance.

Primary outcomes:
measure: Standardized uptake value of 18F-FES in BC
timeFrame: through study completion, an average of 1 year
measure: Lesions detected by 18F-FES PET/CT
timeFrame: through study completion, an average of 1 year
measure: Compared with 18F-FDG PET/CT
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Overall survival
timeFrame: 3 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Li Huo, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06702670: Anticholinergics for Cervical Edema in Labor
Official title: Anticholinergics for Cervical Edema in Labor (ACCEL)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Labor Dystocia
Keywords: dilation
labor
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2024-11-25
Enrollment: 200
Sex: FEMALE
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 is to is to determine the clinical effectiveness of a single dose of intravenous (IV) medication for the prevention of labor arrest and cesarean delivery in primiparous women undergoing trial of labor.


Eligibility criteria: Inclusion Criteria:

* Primiparous
* Viable single intrauterine pregnancy

  -≥ 34 weeks of gestation
* Ruptured membranes
* Category I tracing at time of inclusion
* Active phase of labor (\>=6 cm of cervix dilation)

Exclusion Criteria:

* Category II or III tracing
* Allergy to the study medication (IV Diphenhydramine)

Primary outcomes:
measure: Number of participants that achieve complete dilation of cervix (10cm)
timeFrame: from start of treatment upto 4 hours
measure: Number of participants that achieve complete dilation of cervix (10cm)
timeFrame: from start of treatment upto 6 hours
Secondary outcomes:
measure: Number of participants who have vaginal delivery after protracted labor
timeFrame: End of delivery (an average of upto 6 hours after start of treatment)
measure: Number of participants who have Postpartum complications captured as composite maternal morbidity
timeFrame: from hospitalization up to 6 weeks postpartum
measure: Number of neonates that had adverse events
timeFrame: from birth up to 6 weeks post-delivery
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Samantha Antonioli, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03498170: The Effect of Itraconazole on BCT197 Exposure in Healthy Male Participants
Official title: An Open-label, 2-period, Single-sequence, Crossover Study to Evaluate the Effect of Multiple Oral Dosing of Itraconazole on BCT197 Systemic Exposure in Healthy Male Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Interaction
Keywords: Healthy Male Volunteers
Lead sponsor: Mereo BioPharma
Sponsor class: INDUSTRY
First posted: 2018-04-13
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An Open-label, 2-period, Single-sequence, Crossover Study to Evaluate the Effect of Multiple Oral Dosing of Itraconazole on BCT197 Systemic Exposure in Healthy Male Participants.

Detailed description: This will be an open label study conducted in healthy male participants at a single centre. Each participant will participate in a screening visit and 2 study periods. At the first study period, all participants will receive a single dose of BCT197 and at study period 2, all participants will receive 14 daily doses of itraconazole and a single dose of BCT197.

Eligibility criteria: Inclusion Criteria:

* Healthy male participants.
* Non-smokers (including e-cigarettes).
* Body mass index (BMI) ≥ 18 and ≤ 30 kg/m2.
* Willing to use highly effective barrier contraception methods.
* Male participants must not donate sperm during the study.

Exclusion Criteria:

* Any participants with pre-existing active skin disease.
* Laboratory values at screening which are deemed to be clinically significant.
* Participants with abnormal liver function tests.
* 12 Lead ECG with QTcF \>450 msec.
* Allergy to any of BCT197 excipients.
* Known hypersensitivity or intolerance to itraconazole.
* Taking medications known to cause QTc prolongation.
* Positive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C.
* Any clinically significant illness within 30 days prior to study drug administration.
* Participants who, in the opinion of the Investigator, are unsuitable for participation in the study.

Primary outcomes:
measure: Maximum Measurable Plasma Concentration (Cmax) BCT197 in the presence and absence of itraconazole.
timeFrame: Pre-dose to Day 15
measure: Area under the plasma concentration-time curve (AUC) BCT197 in the presence and absence of itraconazole.
timeFrame: Pre-dose to Day 15
Secondary outcomes:
measure: The number of adverse events during administration of BCT197 alone and in the presence of itraconazole.
timeFrame: Day 1 to Day 21
Other outcomes:
measure: Corrected QT interval of the electrocardiogram (QTc).
timeFrame: Pre-dose to Day 15
Locations:
city: Miami
country: United States
facility: inVentiv Health Clinical Research Services LLC
state: Florida
Study officials:
affiliation: Mereo BioPharma
name: Jacqueline Parkin, PhD FRCP
role: STUDY_DIRECTOR
References:
Clinical trial NCT04327570: In-depth Immunological Investigation of COVID-19.
Official title: In-depth Characterisation of the Dynamic Host Immune Response to Coronavirus SARS-CoV-2
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronavirus Infections
Keywords: COVID-19
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2020-03-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients (\>18 years old) that are admitted to UZ Leuven from March 2020 until September 2026 with PCR-confirmed and/or CT-confirmed SARS-CoV-2 disease are eligible for inclusion.

Brief summary: The COntAGIouS trial (COvid-19 Advanced Genetic and Immunologic Sampling; an in-depth characterization of the dynamic host immune response to coronavirus SARS-CoV-2) proposes a transdisciplinary approach to identify host factors resulting in hyper-susceptibility to SARS-CoV-2 infection, which is urgently needed for directed medical interventions.

Detailed description: The overall aim of this prospective study is to provide an in-depth characterization of clinical and immunological features of patients hospitalized in UZ Leuven because of SARS-CoV-2 infection. For this purpose, clinical data and blood, nasopharyngeal/rectal swab, and if safe, bronchoalveolar lavage (BAL) fluid and lung tissue samples will be collected from PCR- or CT-confirmed COVID-19 patients, with varying degrees of disease severity. Assessed characteristics will be compared between severe and non-severe COVID-19 patients, and between COVID-19 positive and negative ('control') patients.

Eligibility criteria: Inclusion Criteria:

* Patients \>/= 18 years old AND
* Hospitalised with PCR-confirmed and/or CT-confirmed SARS-CoV-2 disease

Exclusion Criteria:

* Age \< 18 years old
* No informed consent

Primary outcomes:
measure: Clinical Features
timeFrame: 6 months
measure: Immune host response at systemic level
timeFrame: 6 months
measure: Immune host response at local level
timeFrame: 6 months
measure: Host genetic variation
timeFrame: 6 months
Secondary outcomes:
measure: Comparison severe and non-severe COVID-19 hospitalised patients
timeFrame: 6 months
measure: Comparison severe and non-severe COVID-19 hospitalised patients
timeFrame: 6 months
measure: Correlation of findings with outcome
timeFrame: 6 months
measure: Correlation of immune profiling - microbiome
timeFrame: 6 months
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
affiliation: UZ Leuven
name: Joost Wauters, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00288470: A Double-blinded Evaluation of Safety and Efficacy of Hylaform and Hylaform Plus Compared to Zyplast.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Facial Wrinkles
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-02-08
Sex: ALL
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Primary purpose: TREATMENT

Brief summary: A clinical study to investigate the safety and efficacy of Hylaform and Hylaform Plus for correction of facial wrinkles.


Eligibility criteria: Inclusion Criteria:

* bilateral nasolabial folds with severity score 3 or 4 on the 6-point grading scale

Exclusion Criteria:

* pregnant/lactating women
* patients who previously received permanent facial implants or using ovet-the-counter products

Primary outcomes:
measure: Non-inferiority as compared to standard of care as assigned by blinded reviewer.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Genzyme, a Sanofi Company
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT06594770: Time of Treatment in HALL Technique Vs ART
Official title: Time of Treatment of Hall Technique Versus Atraumatic Restorative Technique in the Management of Carious Primary Molars: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Healthy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 34
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to assess the time of treatment of Hall Technique versus Atraumatic Restorative Technique in the management of carious primary molars. The main questions it aims to answer are:

* Does the Hall Technique provide a faster and pain-free treatment compared to ART?
* How do the outcomes of both techniques impact children's acceptance and behavior? Researchers will compare the Hall Technique, which uses preformed metal crowns without caries removal, to Atraumatic Restorative Treatment, which uses hand instruments to selectively remove carious tissue.

Participants will:

* Receive treatment using either the Hall Technique or ART in a single session.
* Attend follow-up visits to monitor the effectiveness and acceptance of the treatment.
* Complete assessments on their experience and comfort during and after the procedure.


Eligibility criteria: Inclusion Criteria:

* Age: From 4 to 6 years.
* Caries in primary molars within enamel/dentin with vital pulp.
* Healthy children.
* Cooperative children

Exclusion Criteria:

* Presence of signs and symptoms of necrosis.
* Root caries.
* History of spontaneous pain.

Primary outcomes:
measure: time of treatment
timeFrame: during the procedure
Secondary outcomes:
measure: Postoperative Pain and discomfort
timeFrame: immediately after the procedure , 3month ,6 month and 12 month
measure: Child behavior
timeFrame: during the procedure
measure: Canine overbite: HT
timeFrame: preoperatively , immediately after the procedure , 3 month , 6 month, 12 month
measure: Child anxiety
timeFrame: during the procedure
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00006270: Study of the Approximate Entropy of Adrenocorticotropic Hormone and Cortisol Secretion in Patients With Head Injury
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Brain Injury
Craniocerebral Trauma
Keywords: brain injury
neurologic and psychiatric disorders
rare disease
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
Collaborators: name: University of Texas
First posted: 2000-09-12
Enrollment: 32
Sex: ALL
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no

Brief summary: OBJECTIVES: I. Determine the randomness of adrenocorticotropic hormone (ACTH) and cortisol secretion using approximate entropy in patients who have sustained a head injury.

II. Determine the correlation between randomness of ACTH and cortisol secretion and stages of sleep in these patients.

Detailed description: PROTOCOL OUTLINE: Patients are stratified according to type of injury (closed head injury due to trauma vs vascular accidents). Patients are admitted two times for overnight assessment.

Admission 1: Patients receive cosyntropin IV. Blood is drawn at 30 and 60 minutes after IV infusion. Patients receive oral metyrapone before sleep. A sham sleep study is conducted through the night and patients' blood is drawn in the morning.

Admission 2: At least 2 weeks after admission 1, patients return for an overnight admission. Starting in the evening, blood is drawn every 15 minutes for 12 hours. A sleep study is conducted through the night.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Patients who have sustained head injury

Closed head injury from trauma OR

Vascular accidents like strokes and hemorrhages

--Prior/Concurrent Therapy--

Endocrine therapy: No concurrent cortisol replacement

Other: No blood donation during and for 1 month after study

--Patient Characteristics--

Hematopoietic: Hemoglobin normal

Other:

* No hypopituitarism
* No body mass index of 28 or greater
* Not pregnant or nursing
* Must have normal menstrual cycles
* No severe mental impairment
* Must not require legal guardian

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Galveston
country: United States
facility: Transitional Learning Community
state: Texas
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
Study officials:
affiliation: University of Texas
name: Randall Urban
role: STUDY_CHAIR
References:
Clinical trial NCT00005370: Longitudinal Study of Cortisol and Pulmonary Function
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Diseases, Obstructive
Chronic Obstructive Pulmonary Disease
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-05-26
Sex: ALL
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To conduct a longitudinal study of the relationship between the rate of decline of pulmonary function and measurements of cortisol concentration and excretion in a sample of middle-aged and older men and their wives. The study tested the hypothesis that persons whose plasma cortisol concentrations were relatively low, albeit within the normal range, were predisposed to excessively rapid deterioration of pulmonary function during aging.

Detailed description: BACKGROUND:

It was hoped that the study would provide important insights into the pathogenesis of chronic obstructive pulmonary disease with potential implications for prevention and early therapeutic intervention.

DESIGN NARRATIVE:

All subjects participating in the Normative Aging Study were recruited for the study at the time of their next scheduled examination. Twenty-four hour urinary excretion of free cortisol, morning serum cortisol concentration, and pre- and post-bronchodilator spirometric indices were measured. For the 700 subjects who were recruited during years one and two of the study, these measurements were repeated when subjects returned for their next triennial examination in years four and five of the study. Respiratory illness and smoking questionnaire data, total and differential leukocyte counts, and methacholine inhalation challenge test data were also available at both time points. The specific aims of the study were to examine: (1) the cross-sectional relationship between level of pulmonary function and both morning serum cortisol concentration and 24-hour urinary free cortisol excretion; (2) the relationship between the rate of decline of pulmonary function during the follow-up interval and these measurements of cortisol concentration and excretion; (3) whether these relationships were modified by smoking history, blood total leukocyte count, methacholine airway responsiveness, or other characteristics; and (4) the stability over time of serum cortisol concentration and urinary cortisol excretion in this aging population.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06385470: Treatment of Cantonese Speakers With Childhood Apraxia of Speech
Official title: Treatment of Cantonese Speakers With Childhood Apraxia of Speech
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Childhood Apraxia of Speech
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: University of Vermont
name: The University of Hong Kong
First posted: 2024-04-26
Enrollment: 4
Sex: ALL
Minimum age (years): 3
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The proposed study aims to investigate the efficacy of the Dynamic Temporal and Tactile Cueing treatment in Cantonese-English bilingual speakers with childhood apraxia of speech.

Detailed description: Four CE children with CAS will be recruited and receive two versions of the DTTC treatment (i.e., DTTC in English \[DTTC-E\] and DTTC in Cantonese \[DTTC-C\]). After the initial assessment and baseline probe sessions, all the participants will be randomly assigned to receive either DTTC-E or DTTC-C in the first 6-week treatment phase. Then, the between-treatment probe sessions will be conducted during a 2-week washout period. This will be followed by the second 6-week treatment phase, which will be the other version of DTTC. Post-treatment probe sessions will be conducted one week and one month after completion of the second treatment.

Participants' speech productions will be transcribed and evaluated based on their accuracy in phonemes, stress, and tone. Growth curve analysis (Mirman, 2014) will be conducted to examine the group differences in the outcome measures across the treatment sessions.

Eligibility criteria: Inclusion Criteria:

* (1) 3;0 - 11;11 (years;months) years of age at treatment commencement;
* (2) speak both Cantonese and English: One caregiver one language for at least one year; speaking different languages at home versus school; and/or speak different languages at different times of day;
* (3) no concomitant developmental disorders including autism spectrum disorder;
* (4) no structural abnormalities that affect speech, such as cleft lip and/or palate;
* (5) no uncorrected vision impairment; and
* (6) no hearing loss;
* (7) CAS diagnosis confirmed by the research team based on the available diagnostic criteria in Cantonese speakers, which will be described in the next section

Exclusion Criteria:

-

Primary outcomes:
measure: Phonemes accuracy
timeFrame: Change Before, Between, 1-week and 5-week post DTTC treatment
measure: Stress accuracy
timeFrame: Change Before, Between, 1-week and 5-week post DTTC treatment
measure: Tone accuracy
timeFrame: Change Before, Between, 1-week and 5-week post DTTC treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Kowloon
country: Hong Kong
facility: The Hong Kong Polytechnic University
Study officials:
affiliation: Study Principal Investigator
name: Min Ney Wong, PhD
role: PRINCIPAL_INVESTIGATOR
References: