louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01057030: Multiple Dose Japanese Bridging Study
Official title: Randomized, Double-Blinded, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-708163 125 mg in Healthy Japanese and Non-Japanese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer Disease
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2010-01-27
Enrollment: 22
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to assess the safety and tolerability of multiple oral daily doses of BMS-708163 in healthy young male subjects


Eligibility criteria: Inclusion Criteria:

* Healthy Japanese and non-Japanese subjects
* Japanese subjects must be first generation Japanese and must demonstrate both maternal and paternal Japanese ancestry
* Non-Japanese subjects must not be of Japanese or Asian descent, ie, neither parent nor grandparent was born in Japan or in any Asian country
* BMI of 19 to 25 kg/m², for Japanese and non-Japanese subjects
* Men ages 20 to 45 years

Exclusion Criteria:

* Serum creatinine values above the normal range
* Urine protein or blood levels above the normal range
* Liver function tests above the normal range
* TSH, free T3, or free T4 outside the normal range
* Amylase or lipase levels above the normal range
* Positive Fecal Immunochemical Test (FIT™)

Primary outcomes:
measure: BMS-708163 or placebo in Japanese and non-Japanese: Safety and tolerability (AE's, ECG, vital signs, safety labs)
timeFrame: Every day for 28 days
Secondary outcomes:
measure: BMS-708163 pharmacokinetic parameters (Cmax, Cmin, Ctrough, Tmax, AUC(TAU), AI, and CLT/F and T-HALF (only following Day 14 dose))
timeFrame: Days 1, 7, and 14
Other outcomes:
Locations:
city: Glendale
country: United States
facility: California Clinical Trials Medical Group
state: California
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT04687930: Genicular Nerve Block in Juvenile Idiopathic Arthritis
Official title: Genicular Nerve Block in Juvenile Idiopathic Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Juvenile Idiopathic Arthritis
Persistent Knee Arthritis
no Intra-articular Injection in the Last 3 Months
no Other Cause for Chronic Kneearthritis
Keywords: Juvenile rheumatoid arthritis
knee joint
Nerve block
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2020-12-29
Enrollment: 104
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: N=104 juvenile idiopathic arthritis patients diagnosed after ILAR criteria with unilateral persistent knee arthritis. They will be randomly assigned into two groups; group 1 will receive genicular nerve block, group 2 intra-articular triamcinolone. Both groups will be examined by SOLAR ultrasound scoring system, Visual analogue scale and Lysholm score at 0, 2 and 12 weeks. A semi-quantitative score will be used to assess tenderness and swelling at the same intervals.


Eligibility criteria: Inclusion Criteria:

* juvenile idiopathic arthritis with persistent knee arthritis
* age below 16

Exclusion Criteria:

* severe knee osteoarthritis
* peripheral neuropathy,
* psoriatic arthritis,
* those under anticoagulant therapy, skin infection,
* prior knee injection in the last 3 months3
* those who have an allergy to Bupivacaine

Primary outcomes:
measure: Change in SOLAR score over time
timeFrame: Baseline, 2 weeks and 12 weeks
measure: Change in visual analogue scale over time
timeFrame: Baseline, 2 weeks and 12 weeks
measure: Change in Lysholm score over time
timeFrame: Baseline, 2 weeks and 12 weeks
measure: Change in semiquantitative score for swelling and tenderness over time
timeFrame: Baseline, 2 weeks and 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag university
Study officials:
References:
citation: Radwan A, Ohrndorf S, Aly H, Hamed M, Khalifa A, Elsaman AM. Genicular nerve block in juvenile idiopathic arthritis: a randomized clinical trial. Clin Rheumatol. 2023 Mar;42(3):879-888. doi: 10.1007/s10067-022-06389-4. Epub 2022 Oct 5.
Clinical trial NCT02884830: Nocturnal Continuous Positive Airway Pressure in Chronic Obstructive Pulmonary Disease Patients
Official title: Does Nocturnal Continuous Positive Airway Pressure Use Improves Sleep Quality in Chronic Obstructive Pulmonary Disease Patients?
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Centre Hospitalier Universitaire Saint Pierre
Sponsor class: OTHER
First posted: 2016-08-31
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Static hyperinflation is frequent in Chronic obstructive pulmonary disease (COPD) , resulting in increased end expiratory lung volume and positive end expiratory pressure (PEEPi) at the end of a normal expiration.

Static hyperinflation worsens the work of breathing is increases patient's dyspnea.

The application of a continuous positive airway pressure (CPAP) has been shown to improve static hyperinflation and to decrease the work of breathing.

Sleep is deteriorated in COPD patients, and causal factors includes static hyperinflation. The purpose of our study is to assess the effect of nocturnal CPAP on sleep quality and functional respiratory parameters.

Detailed description: Chronic obstructive pulmonary disease (COPD) is characterized by an airflow obstruction, inducing a flow limitation. As a consequence, we observe in these patients an increased end expiratory lung volume and a positive end expiratory pressure (PEEPi) at the end of a normal expiration.

Patients are breathing at higher pulmonary volumes: this is the concept of static hyperinflation.

This worsens the breathing pattern because in this situation, the work of breathing is increased such that dyspnea increases.

The application of a continuous positive airway pressure (CPAP) has been shown to improve static hyperinflation and to decrease the work of breathing.

Sleep is deteriorated in COPD patients, and causal factors includes static hyperinflation, cough, depression. Moreover, normal physiological changes occuring during sleep in COPD patients are leading to deterioration of gaseous exchanges. The purpose of our study is to assess the effect of nocturnal CPAP on sleep quality and functional respiratory parameters.

Eligibility criteria: Inclusion Criteria:

* stable chronic obstructive pulmonary disease patients exhibiting a FEV1\<80 %,

Exclusion Criteria:

* Known sleep apnea syndrome or other sleep disease interfering with sleep quality
* Body mass index \> 30 kg/m2
* heart failure
* hypnotics intake

Primary outcomes:
measure: sleep quality
timeFrame: day 1
Secondary outcomes:
measure: static hyperinflation
timeFrame: day 1
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00500630: Objective Evaluation of Shoulder Pathology and Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glenohumeral Osteoarthritis
Rotator Cuff Disease
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
First posted: 2007-07-13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: The goal of this study was to clinically validate a new device for the objective outcome evaluation of adult patients undergoing shoulder surgery for glenohumeral osteoarthritis and rotator cuff disease, using the activities of daily living described in the Simple Shoulder Test (SST) as a reference.

The study was set up as a clinical trial including patients over an observation period of one year and a control group of subjects. Clinical evaluations will be made at baseline, 3 months, 6 months and 1 year after surgery by two independent observers. Miniature sensors each containing three 3D gyroscopes and three 3D accelerometers will allow computing new kinematic scores. They will be compared to the regular SST, DASH, ASES and Constant scores.


Eligibility criteria: Inclusion Criteria:

* at least 18 years old
* patients with a unilateral rotator cuff disease implying a transfixiant supraspinatus rupture of at least 1 cm2, as determined by Magnetic Resonance Imaging (MRI), or a unilateral glenohumeral osteoarthritis stage II or III according the radiologic criteria published by Koss
* informed and signed consent

Exclusion Criteria:

* Patients who had a previous shoulder surgery (open or arthroscopic)
* Patients who had a contralateral shoulder pathology

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Hopital Orthopédique de la Suiss Romande
state: CH
Study officials:
affiliation: Centre Hospitalier Universitaire Vaudois - University of Lausanne
name: Brigitte M Jolles, MD, MSc
role: STUDY_DIRECTOR
References:
Clinical trial NCT02367430: Critical Time Intervention for Individuals With Hoarding Disorder
Official title: Critical Time Intervention for Individuals With Hoarding Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hoarding Disorder
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
First posted: 2015-02-20
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate whether a well-established case management model called Critical Time Intervention (CTI) can help individuals with hoarding disorder who are concerned about the risk of eviction. Each individual with hoarding disorder will be assigned to work with a CTI Specialist for 9 months, who will provide referrals for mental health treatment, legal consultations, and registration for entitlements. All participants will be offered a facilitated group intervention called the Buried in Treasures Workshop. The CTI Specialist will also facilitate reconnecting the individual with supportive family/friends and will monitor and support the de-cluttering of the patient's home.


Eligibility criteria: Inclusion Criteria:

* primary Hoarding Disorder
* age 18 or over
* Individuals concerned with the threat of eviction due to clutter
* Patient must be physically healthy
* Willing and able to understand and complete consent procedure
* English speaking

Exclusion Criteria:

* Not primary Hoarding Disorder
* Severly depressed patients; Hamilton depression rating scale greater than 30 or judged clinically to be at risk of suicide with Columbia Suicide Severity Rating Scale

Primary outcomes:
measure: Savings Inventory-Revised
timeFrame: Baseline, 3 months, 6 months and 9 months
measure: Clutter Image Rating Scale
timeFrame: Baseline, 3 months, 6 months and 9 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Columbia-NYSPI-RFMH
name: H Blair Simpson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Carolyn I Rodriguez, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Millen AM, Levinson A, Linkovski O, Shuer L, Thaler T, Nick GA, Johns GK, Vargas SM, Rottier KA, Joyner E, Girson RB, Zwerling J, Sonnenfeld D, Shapiro AM, Tannen A, Conover S, Essock S, Herman D, Simpson HB, Rodriguez CI. Pilot Study Evaluating Critical Time Intervention for Individuals With Hoarding Disorder at Risk for Eviction. Psychiatr Serv. 2020 Apr 1;71(4):405-408. doi: 10.1176/appi.ps.201900447. Epub 2020 Jan 8.
Clinical trial NCT04245930: Bovine Pericardial Patch and TiLOOP® Bra Mesh in Immediate Implant Breast Reconstruction.
Official title: A Randomized and Controlled Study of Efficacy and Safety of Bovine Pericardial Patch and TiLOOP® Bra Mesh in Patients With Immediate Implant Breast Reconstruction.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Implant Breast Reconstruction
TiLOOP® Bra Mesh
Bovine Pericardial Patch
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
First posted: 2020-01-29
Enrollment: 176
Sex: FEMALE
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 study is the first randomized and controlled study assessing the efficacy and safety of bovine pericardial patch and TiLOOP® bra mesh in patients with immediate implant breast reconstruction


Eligibility criteria: Inclusion Criteria:

1. Patients diagnosed with I\~II stage breast cancer and Intent to receive NSM or SSM and implant based breast reconstruction
2. Do not smoking in the last 4 weeks or more
3. Mental health patients
4. Signed consent to participate

Exclusion Criteria:

1. Locally advanced stage patients or patients with distal metastasis
2. Patients received thoracic wall radiotherapy or will receive radiotherapy
3. Smoking in the last 4 weeks
4. Anticipated implant volume more than 600cc
5. Patients of pregnancy or lactation
6. Patients received neoadjuvant therapy

Primary outcomes:
measure: Complication Rates
timeFrame: up to 12 months after surgery
Secondary outcomes:
measure: Patient satisfaction-Breast-Q questionnaire
timeFrame: up to 12 months after surgery
measure: Cosmetic outcome of reconstructed breast
timeFrame: Immediately, up to 3 months, 6 months and 12 months after surgery
measure: The rate of surgical revision of reconstructed breasts
timeFrame: up to 12 months after surgery
measure: Health economics-inpatient cost
timeFrame: up to 12 months after surgery, including the cost of surgical revision
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
Study officials:
affiliation: Tianjin Medical University Cancer Institute and Hospital
name: Jian Yin, MD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01720030: Levosimendan in Acute Kidney Injury Study
Official title: Prospective, Randomized, Monocenter, Double Blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Levosimendan in Intensive Care Patients With Acute Kidney Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Acute Kidney Injury
Keywords: Renal
Acute Kidney Injury
AKI
Levosimendan
Simdax
Renal perfusion
Mortality
Renal flow
Lead sponsor: VieCuri Medical Centre
Sponsor class: OTHER
Collaborators: name: Orion Corporation, Orion Pharma
First posted: 2012-11-01
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We hypothesise that levosimendan will have a positive influence on renal function during acute kidney injury in adult intensive care patients.

Detailed description: The purpose of this trial is to evaluate whether the use of levosimendan is able to improve renal function.

Eligibility criteria: Inclusion Criteria:

* Clinically diagnosed adult patients with AKI

Exclusion Criteria:

* Failure to obtain written consent to participate from patient or legal representative (by deferred consent)
* Patients entering the ICU for post-operative observation with an estimated length of stay less than 24 hrs.
* Moribund patients
* Patients under the age of 18
* Pregnancy
* Patients suffering from pre-existing renal failure (elevated NGAL values without apparent rise in creatinine values)
* Renal replacement therapy initiated before admission due to Chronic Kidney Disease
* Hypersensitivity to levosimendan experienced by previous treatments
* Severe hypotension and tachycardia
* Significant mechanical obstruction affecting ventricular filling or outflow or both.
* Severe hepatic impairment (ALAT/ASAT\>400U/L)
* Patients will be excluded if the treating physician judges that study participation is undesirable for medical, medical-ethical or other reasons
* Known history of Torsades de Pointes

Primary outcomes:
measure: Change in renal function
timeFrame: Baseline and every 24 hours until end ICU stay
Secondary outcomes:
Other outcomes:
Locations:
city: Venlo
country: Netherlands
facility: VieCuri Medical Center
state: Limburg
Study officials:
affiliation: VieCuri Medical Centre
name: Jos Le Noble, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04951830: Clinical and MRI Finding of The Temporomandibular Joint Stuck Disk
Official title: Clinical and MRI Finding of The Temporomandibular Joint Stuck Disk
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: TMJ Disc Disorder
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2021-07-07
Enrollment: 900
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The retrospective study included patients seeking treatment for TMD at Al-Azhar University Hospital and the outpatient clinic at the Faculty of Dental Medicine of Al-Azahr University. The sample originally included patients who provided consent to participate in this study and who ultimately underwent treatment for TMJD between 2008 and 2019.

Brief summary: the study aimed to evaluate the clinical and MRI finding of TMJ with stuck disk with predication of the risk factors

Detailed description: the study aimed to evaluate the clinical and MRI finding of TMJ with stuck disk with predication of the risk factors. Study design: this retrospective study included patients diagnosed as TMJ internal derangement and all the patients examined by MRI from 2008 to 2019. Cases with loss of continuity of articular disk or the posterior attachment of the disk were considered as positive cases.

Eligibility criteria: Inclusion Criteria:

* patients seeking treatment for TMD at Al-Azhar University Hospital and the outpatient clinic at the Faculty of Dental Medicine of Al-Azahr University.

Exclusion Criteria:

* Exclusion Inclusion criteria: Patients were included if they were older than 18 years and diagnosed with TMJD. criteria for this study included systemic diseases (the presence of polyarthritis or other rheumatic diseases), contraindications for MRI (e.g., implanted metal or medical devices, claustrophobia), the presence of neurologic disorders, head and neck cancer, oral submucous ﬁbrosis, a history of TMJ surgery, a history of previous nonsurgical treatment such as occlusal splints, and a history of joint injection with HA/PRP. Trauma patients with subcondylar fracture and patients with congenital and developmental disorders of the TMJ were also excluded from the study.

Primary outcomes:
measure: VAS
timeFrame: baseline (pre treatment)
measure: MOUTH OPENING
timeFrame: baseline (pre treatment)
Secondary outcomes:
measure: JOINT SOUND
timeFrame: baseline (pre treatment)
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dental Medicine Alazhar University
state: Nasr City
Study officials:
References:
Clinical trial NCT02253030: OCT Angiography in Wet AMD
Official title: Optical Coherence Tomography Angiography in Neovascular Age-related Macular Degeneration
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neovascular (Wet) Age-related Macular Degeneration (AMD)
Keywords: AMD
OCT
Angiography
Macular degeneration
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2014-10-01
Enrollment: 160
Sex: ALL
Minimum age (years): 50
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Both female and male participants over the age of 50 are being studied.

Brief summary: The primary goals of this study are to use optical coherence tomography (OCT) angiography (blood vessel mapping) to:

1. diagnose the presence of new blood vessels in wet age-related macular degeneration (AMD)
2. evaluate patients undergoing treatment for wet AMD
3. determine if reduced flow to the choroid is a risk factor for developing wet AMD.


Eligibility criteria: Inclusion Criteria (Groups with wet AMD):

* Adults aged 50 and older with clinical findings of treatment-naïve (never treated) neovascular AMD with active new blood vessel growth confirmed by clinical testing will be considered

Inclusion Criteria (Group with healthy eyes)

* No evidence of retinal disease
* Refractive error greater than +3.00 diopters or -7.00 diopters (glasses Rx)
* No recent eye surgery in the last 4 months
* No significant cataract to interfere with the quality of the imaging

Exclusion Criteria (All Groups):

* Inability to give informed consent
* Significant kidney disease
* Blood pressure greater than 180/110
* Previous macular laser treatment
* Inability to maintain stable fixation during OCT imaging
* Visual acuity worse than 20/200

Primary outcomes:
measure: Measure of choroidal neovascular (CNV) vessel area in mm2
timeFrame: 1 year
measure: Measure of CNV membrane area in mm2
timeFrame: 1 year
measure: Measure of CNV length density in mm
timeFrame: 1 year
measure: Measure of retinal fluid volume in mm3
timeFrame: 1 year
measure: Measure of drusen area in mm2
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Casey Eye Institute, Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Steven Bailey, MD
role: PRINCIPAL_INVESTIGATOR
References: