louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00648323: Evaluation Of The Efficacy And Safety Of The Doxasozin Gastrointestinal Therapeutic System (GITS) In Patients With Prostate Enlargement
Official title: A Prospective, Open-Labeled Trial of the Safety and Efficacy of Doxazosin GITS in Patients With Benign Prostate Hyperplasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Prostate
Keywords: Benign Prostate Hyperplasia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-04-01
Enrollment: 80
Sex: MALE
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objectives were to determine the efficacy and safety of the GITS formulation of Doxazosin in Taiwanese patients with prostate enlargement.


Eligibility criteria: Inclusion Criteria:

* Taiwanese male subjects between 50 and 80 years of age who had: a primary diagnosis of BPH, defined as having an enlarged prostate (confirmed by digital rectal examination \[DRE\] and/or B-mode ultrasound); an IPSS score of ≥12; and a Qmax in the range of 5 to 15 mL/sec in a total voided volume of ≥150 mL, were eligible for the study.

Exclusion criteria include but not limited to:

* Previous prostate surgery, presence of a prostate stent or microwave thermotherapy and/or balloon dilatation within the previous 6 months
* Concomitant therapy or previous therapy within 14 days with agents known to affect bladder or urethral function.

Primary outcomes:
measure: Change in the maximum urinary flow rate (Qmax) from baseline
timeFrame: 8 weeks
measure: Change in the International Prostate Symptom Score (IPSS) total score from baseline
timeFrame: 8 weeks
Secondary outcomes:
measure: Change in the International Prostate Symptom Score (IPSS) total score from baseline
timeFrame: 4 weeks
measure: Change in the maximum urinary flow rate (Qmax) from baseline
timeFrame: 4 weeks
measure: Change in the quality of life (QoL) assessment index score from baseline
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Pfizer Investigational Site
city: Taichung
country: Taiwan
facility: Pfizer Investigational Site
city: Taipei
country: Taiwan
facility: Pfizer Investigational Site
city: Taoyuan
country: Taiwan
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT05074823: Comparing Three Different Doses of Intrathecal Ketamine
Official title: Analgesic Effects of Three Different Doses of Intrathecal Ketamine as an Adjuvant to Intrathecal Bupivacaine in Patients Undergoing Knee Arthroscopy. A Randomized Prospective Double-blinded Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ketamine Causing Adverse Effects in Therapeutic Use
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-10-12
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to compare the postoperative analgesic effect of three different doses of intrathecal ketamine as an adjuvant to bupivacaine in patients undergoing knee arthroscopy.

Detailed description: A meta-analysis of adult human randomized controlled studies that compared single dose perioperative intrathecal ketamine plus intrathecal bupivacaine to bupivacaine alone in spinal anesthesia suggests that there is a benefit to using intrathecal ketamine as an adjunct to bupivacaine in multimodal analgesia. However, there are still knowledge and experience gaps regarding neuraxial ketamine dosing in this regard.

Aim of the study:

The aim of this study is to compare the postoperative analgesic effect of three different doses of intrathecal ketamine as an adjuvant to bupivacaine in patients undergoing knee arthroscopy.

Eligibility criteria: Inclusion Criteria:

* Age: 18-70 years.
* BMI: 20-30 kg.m2
* Sex: both males and females.
* ASA physical status: I-III.
* Operation: knee arthroscopy.

Exclusion Criteria:

* Patient's refusal to participate in the study.
* Aged less than 18 years,
* known allergy to L.A.,
* Coagulopathy or thrombocytopenia,
* height less than 150 cm, morbidly obese infection at the site of injection.
* Chronic pain syndromes,
* pregnant woman
* Patients on regular use of analgesic or who received analgesic 24 h before surgery.

Primary outcomes:
measure: Time to first analgesic request
timeFrame: First 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University hospital
Study officials:
References:
Clinical trial NCT06784323: Tailored Anti-Inflammatory (A-I) Diet for Hispanics With Ulcerative Colitis (UC)
Official title: A Culturally Tailored Anti-inflammatory Diet for Hispanic Patients With Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ulcerative Colitis
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2025-01-20
Enrollment: 122
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to test the effect of an anti-inflammatory diet that incorporates native foods of the Hispanics/Latino (H/L) diet on disease remission in H/L patients with Ulcerative Colitis (UC) and to identify biomarkers of response to dietary therapy.


Eligibility criteria: Inclusion Criteria:

* Documented diagnosis with ulcerative colitis from medical records.
* Self-Identify as Hispanic /Latino
* Ages 16-75
* SCCAI between 3-9 (no greater than 12 bowel movements a day)
* Fecal calprotectin \> 150mg/dl.
* On stable medications for their disease for the past 3 months
* Likeability of Latin foods (starchy vegetables, rice, tropical fruits, plantains)
* No recent Inflammatory Bowel Disease (IBD) related hospitalization in the last month.

Exclusion Criteria:

* Diagnosis of Crohn's Disease (CD).
* Prior ileoanal anastomosis (J-pouch) or diversion
* No recent hospitalizations on the last 4 weeks
* No Clostridium difficile or enteric infections on the last 4 weeks
* No use of probiotics on the last 4 weeks
* Patients following the specific carbohydrate diet or mediterranean diet or anti-inflammatory diet
* No active cancer or conditions limiting their ability to follow a diet (heart failure, end stage renal disease)
* Pregnancy, breastfeeding or planning to become pregnant during study period
* Use of Total Parenteral Nutrition at the time of screening and during the study period
* Other significant or life-threatening co-morbidities
* The need for antibiotic use during the study period
* Adults unable to consent
* Ages less than 16 and \> 75 years old
* Prisoners

Primary outcomes:
measure: Clinical remission after diet intervention measured by simple clinical colitis activity index (SCCAI)
timeFrame: Up to 8 weeks
measure: Fecal calprotectin
timeFrame: Up to 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Health System
state: Florida
Study officials:
affiliation: University of Miami Health System
name: Oriana Damas, MD, MSCTI
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00398723: Narrowband UVB Treatment in Patients With Vitiligo
Official title: Effects of Narrowband UVB Phototherapy on Melanocyte Proliferation in Patients With Vitiligo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitiligo
Keywords: Narrowband UBV Phototherapy
Skin biopsies
Lead sponsor: Rockefeller University
Sponsor class: OTHER
First posted: 2006-11-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study offers narrowband UVB light therapy to patients who have 5% of their body involved with vitiligo.

The hypothesis is that Narrowband UVB promotes melanocyte proliferation in vitiligo lesions.

Detailed description: All patients will receive phototherapy, with narrowband UVB, three times a week for six months, or a total of 78 treatments. 6mm punch skin biopsies (2) will be done prior to starting therapy, once during treatment (2) and at the completion of the study (2). Clinical assessments and photography will be done parallel to the skin biopsies. Results (clinically and histologically) will be analyzed.

Eligibility criteria: Inclusion Criteria:

* Age 18 years of age or greater
* Vitiligo with extensive skin involvement (\>5% body surface affected).

Exclusion Criteria:

* No treatment with topical steroids, calcineurin inhibitors or vitamin D analogs for at least 4 weeks prior to entering the study.
* No treatment with systemic therapies, including methotrexate, etretinate, PUVA, or cyclosporine 4 weeks prior to entering the study.

Primary outcomes:
measure: Number of melanocytes per unit length of skin surface
timeFrame: pre-treatment, early repigmentation, 75% repigmentation of total body
Secondary outcomes:
measure: Clinical improvement
timeFrame: first visit and last visit
Other outcomes:
Locations:
city: New York
country: United States
facility: Rockefeller University Hospital
state: New York
Study officials:
affiliation: Rockefeller University
name: James Krueger, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03824223: 'Fitness To Fly' Tests In Children With Type II Respiratory Failure
Official title: 'Fitness To Fly' Testing In Children With Neuromuscular Weakness Or Central Hypoventilation: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuromuscular Diseases
Central Hypoventilation
Lead sponsor: Great Ormond Street Hospital for Children NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University College, London
First posted: 2019-01-31
Enrollment: 20
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants randomised to uniform balanced crossover (new/old or old/new hypoxic challenge test components).
Primary purpose: OTHER

Brief summary: The conventional hypoxic challenge test might not predict 'fitness-to-fly' equally well in all patients. Patients at risk of hypercapnia with supplemental oxygen are not well studied. Th investigators will study children who have either neuromuscular weakness or central hypoventilation and who require nocturnal or intermittent daytime ventilator support.

The study also aims to assess feasibility of a randomised controlled trial (RCT) comparing the standard hypoxic standard test to a modified test designed to better suit children with type two respiratory failure.

Detailed description: This study will assess feasibility of pulse oximetry (SpO2), end tidal carbon dioxide (ETCO2) and transcutaneous carbon dioxide partial pressure (TcCO2) measurement during a modified Hypoxic challenge test (HCT) in 12 children with neuromuscular weakness and 12 with central hypoventilation.

Eligibility criteria: Inclusion Criteria:

* ≤18 years
* Neuromuscular weakness or central hypoventilation
* Established nocturnal or intermittent daytime ventilatory support

Exclusion Criteria:

* Unable to sit in the plethysmograph
* Cardiac anomaly with right-to-left shunt

Primary outcomes:
measure: proof of concept outcome 1
timeFrame: during hypoxic challenge test
measure: proof of concept outcome 2
timeFrame: during hypoxic challenge test
Secondary outcomes:
measure: Feasibility outcome 1: recruitment rate
timeFrame: one year
measure: Feasibility outcome 2: protocol completion rate
timeFrame: one year
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Great Ormond Street Hospital for Children NHS Foundation Trust
Study officials:
affiliation: Great Ormond Street Hospital for Children NHS Foundation Trust
name: Katharine C Pike, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05035823: COMMAND Early Feasibility Study: Implantable BCI to Control a Digital Device for People With Paralysis
Official title: Motor NeuroProsthesis to Restore Motor Control for the COMMAND of Digital Devices: An Early Feasibility Study (EFS) of Safety in Subjects With Severe Quadriparesis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Neurologic Disorder
Paralysis
Paralysis; Stroke
Amyotrophic Lateral Sclerosis
Muscular Dystrophies
Spinal Cord Injuries
Stroke, Lacunar
Stroke Brainstem
Cervical Spinal Cord Injury
Spinal Muscular Atrophy
Tetraplegic; Paralysis
Quadriplegia/Tetraplegia
Lead sponsor: Synchron, Inc.
Sponsor class: INDUSTRY
First posted: 2021-09-05
Enrollment: 6
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The Synchron motor neuroprosthesis (MNP) is intended to be used in subjects with severe motor impairment, unresponsive to medical or rehabilitative therapy and a persistent functioning motor cortex. The purpose of this research is to evaluate safety and feasibility.

The MNP is a type of implantable brain computer interface which bypasses dysfunctional motor neurons. The device is designed to restore the transmission of neural signal from the cerebral cortex utilized for neuromuscular control of digital devices, resulting in a successful execution of non-mechanical digital commands.


Eligibility criteria: Inclusion Criteria:

1. Severe quadriparesis
2. Able to give consent
3. Appropriate candidate for neurointerventional procedure
4. Able and willing to access all clinical testing and not impeded by geographical location
5. Proficient in English
6. Have a study partner

Exclusion Criteria:

1. Active condition resulting in immunosuppression
2. Unsuitable for general anesthesia
3. Anaphylactic allergy to contrast media
4. Allergy to nickel
5. History of pulmonary embolism
6. History of recent deep vein thrombosis
7. Psychiatric or psychological disorder
8. No study partner or caregiver
9. Unable to provide evidence of COVID vaccination

Primary outcomes:
measure: Treatment-Related Serious Adverse Events
timeFrame: 12 months post implant
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: University at Buffalo Neurosurgery (UBNS)
state: New York
city: New York
country: United States
facility: Mount Sinai Health System
state: New York
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
References:
Clinical trial NCT02571023: Multicenter Clinical Study on Diagnosis and Treatment of Skull Base Trauma
Official title: Multicenter Clinical Study on Diagnosis and Treatment of Skull Base Trauma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Skull Injury Trauma
Keywords: Skull Base Trauma
microscope surgery
neuroendoscope surgery
Lead sponsor: Shanghai Changzheng Hospital
Sponsor class: OTHER
First posted: 2015-10-08
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All the patients with skull base trauma in inpatient ward.

Brief summary: The purposes of this study are as follows:

1. to collect the largest epidemiological data of skull base trauma and analyze the related influence factors of mortality and morbidity.
2. to establish a set of standard classification methods of skull base trauma and to establish a standard rating scale for each type of trauma.
3. to select optimized conservative and surgical treatments of skull base trauma and to compare the therapeutic effect between microscope surgery and neuroendoscopic surgery.
4. to clear the epidemiological characteristics of the skull base trauma combined with paroxysmal sympathetic hyperactivity.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Skull Base Trauma

Exclusion Criteria:

* N/A

Primary outcomes:
measure: mortality
timeFrame: 1 year
measure: disability rate
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Neurosurgery, Shanghai Changzheng Hospital
state: Shanghai
Study officials:
affiliation: Department of Neurosurgery, Shanghai Changzheng Hospital
name: Lijun Hou, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01224223: Myeloid Suppressors in Inflammation
Official title: Myeloid Suppressors in Inflammation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: asthma
Lead sponsor: University of South Florida
Sponsor class: OTHER
First posted: 2010-10-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Ages eligible for study: 18 to 60 years Genders eligible for study: male and female Signed and dated written informed consent is obtained prior to study blood draw.

Subjects being actively treated for chronic moderate to severe asthma based on National Heart Lung and Blood Institute guidelines (figure 1). Subjects must carry the diagnosis of asthma (made by a physician) for a minimum of six months.

Subjects within the first seven days of an acute asthma exacerbation, as determined by the referring physician.Able to give informed consent.

Brief summary: Myeloid-derived suppressor cells (MDSC) have been studied for their ability to suppress T cell responses in vivo and in vitro. As a result, MDSC can regulate cellular responses to chronic inflammatory conditions such as cancer, leading to the induction of tolerance and, ultimately, tumor escape from immune surveillance.


Eligibility criteria: Inclusion

1. Ages eligible for study: 18 to 60 years
2. Genders eligible for study: male and female
3. Signed and dated written informed consent is obtained prior to study blood draw.
4. Subjects being actively treated for chronic moderate to severe asthma based on National Heart Lung and Blood Institute guidelines (figure 1). Subjects must carry the diagnosis of asthma (made by a physician) for a minimum of six months.
5. Subjects within the first seven days of an acute asthma exacerbation, as determined by the referring physician.
6. Able to give informed consent.

Exclusion Criteria:

1. Use of systemic corticosteroids within the previous two weeks.
2. Pregnant and/or lactating females.
3. Current tobacco use.
4. Severe psychiatric illness.
5. Current illicit substance abuse or dependence and/or abuse of alcohol.
6. Current use of anti-microbial medications.
7. Primary or secondary immunodeficiency.
8. Any clinically significant uncontrolled medical condition that would put the patient's safety at risk.

Primary outcomes:
measure: To identify and characterize specific cell types (human dendritic cells, myeloid-derived suppressor cells and T lymphocytes) that are present in acute and chronic asthma.
timeFrame: one year from start of study
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: USF Asthma, Allergy and Immunology CRU
state: Florida
Study officials:
affiliation: USF Asthma, Allergy and Immunology CRU
name: Richard Lockey, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04118023: 7T MRI to Evaluate Cartilage Defects in the Knee
Official title: Improving Non-Invasive Diagnosis and Grading of Cartilage Defects in the Knee - Accuracy of Ultra High Field 7-Tesla MRI as Compared With Arthroscopy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cartilage Injury
Knee Injuries
Arthropathy of Knee
Cartilage Damage
Knee Pain Swelling
Keywords: 7T Magnetic Resonance Imaging
Clinical
Cartilaginous Lesion
Lead sponsor: The Methodist Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Siemens Medical Solutions
First posted: 2019-10-07
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of a single surgeon in an outpatient clinic.

Brief summary: The investigators propose to prospectively evaluate the accuracy of a novel 7-Tesla (7T) knee MRI protocol for the detection and grading of cartilage lesions in the knee, which is a significant limitation of current MRI techniques.

Detailed description: The investigators hypothesize that 7T MRI will be \~ 80% sensitive for detection of cartilaginous lesions. This will be tested in a prospective multi-reader study of 100 patients who are scheduled to have knee arthroscopy. Patients will have two MRIs of the knee: one standard of care and one experimental 7T MRI. Subjects will visit at one time point prior to scheduled knee arthroscopy, for a session time of \~1-2 hours for a single 7T MRI scan.

Eligibility criteria: Inclusion Criteria:

* Confirmed Knee Symptomatology
* Scheduled Arthroscopic Treatment of Knee
* Adult (equal or greater than 18 years of age)

Exclusion Criteria:

* Active infections
* Less than 18 years of age
* Pregnant

Primary outcomes:
measure: Modified Whole-Organ Magnetic Resonance Imaging Score (WORMS)
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
Study officials:
affiliation: The Methodist Hospital Research Institute
name: Susan Miller, MD, MPH
role: STUDY_CHAIR
References:
Clinical trial NCT02898623: Serological Test for the Diagnosis of TB
Official title: Performances of Immunoassays Based on the Detection of Antibodies Directed Against Mycobacterium Tuberculosis Antigen for the Diagnosis of Active Tuberculosis in Adults
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Active Tuberculosis
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2016-09-13
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with active tuberculosis

Brief summary: TB remains a health problem in France with about 5,000 new cases per year. Development of new screening tests is a priority for TB. The main objective of the study is to evaluate performances of innovative blood tests to identify active tuberculosis in adults patients living in low-prevalence country. Adult patients with possible TB from will be tested for the presence of antibodies directed against M. tuberculosis selected antigens. Positive and negative predictive values will be established based on TB culture results.


Eligibility criteria: Inclusion Criteria:

* Signs of possible Tuberculosis (TB); testing for TB in routine practice (microbiology)

Exclusion Criteria:

* Immunosuppression

Primary outcomes:
measure: Positive and negative predictive values for the diagnosis of active TB
timeFrame: 48 months
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: University Hospital Montpellier Department of microbiology
Study officials:
affiliation: University Hospital, Montpellier
name: Edouard Tuaillon, MD; PhD
role: PRINCIPAL_INVESTIGATOR
References: