louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01194804: E07-001: Safety and Efficacy Extension Study of Eculizumab in Paroxysmal Nocturnal Hemoglobinuria Patients
Official title: Phase II Clinical Study of Eculizumab (h5G1.1-mAb) in Hemolytic Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients: Extension Study to C07-001 Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Paroxysmal Nocturnal Hemoglobinuria
Keywords: Hemolytic Paroxysmal Nocturnal Hemoglobinuria
Eculizumab
PNH
Lead sponsor: Alexion Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: CMIC Co, Ltd. Japan
First posted: 2010-09-03
Enrollment: 27
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study was to assess the long-term safety and efficacy of eculizumab in hemolytic PNH patients who completed the 4-week screening and 12-week treatment period of the C07-001 study. In addition, pharmacokinetic and pharmacodynamic assessments of eculizumab were conducted.


Eligibility criteria: Inclusion Criteria:

* Patients must have fully completed C07-001 study 12-week treatment period

Exclusion Criteria:

* Patients who terminated early from the C07-001 study

Primary outcomes:
measure: Change From Baseline in Lactate Dehydrogenase
timeFrame: 52 weeks (includes 12 weeks of eculizumab treatment in the parent study and 40 weeks in the extension study)
Secondary outcomes:
measure: Change From Baseline in FACIT-Fatigue Scale Total Score
timeFrame: 52 weeks (includes 12 weeks of eculizumab treatment in the parent study and 40 weeks in the extension study)
measure: Change From Baseline in PNH Red Blood Cell (RBC) Count
timeFrame: 52 weeks (includes 12 weeks of eculizumab treatment in the parent study and 40 weeks in the extension study)
measure: Change From Baseline in Number of Units of Packed RBCs Transfused
timeFrame: 52 weeks (includes 12 weeks of eculizumab treatment in the parent study and 40 weeks in the extension study)
measure: Change From Baseline in Plasma Free Hemoglobin
timeFrame: 52 weeks (includes 12 weeks of eculizumab treatment in the parent study and 40 weeks in the extension study)
Other outcomes:
Locations:
Study officials:
References:
citation: Kanakura Y, Ohyashiki K, Shichishima T, Okamoto S, Ando K, Ninomiya H, Kawaguchi T, Nakao S, Nakakuma H, Nishimura J, Kinoshita T, Bedrosian CL, Ozawa K, Omine M. Long-term efficacy and safety of eculizumab in Japanese patients with PNH: AEGIS trial. Int J Hematol. 2013 Oct;98(4):406-16. doi: 10.1007/s12185-013-1404-y. Epub 2013 Aug 11.
Clinical trial NCT03862404: Intrapleural Bupivacaine for Ipsilateral Shoulder Pain After Thoracotomy
Official title: Double-blind Comparison of Intrapleural Bupivacaine and Saline for Ipsilateral Shoulder Pain After Thoracotomy in Patients Receiving Thoracic Epidural Analgesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Post Thoracic Surgery
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2019-03-05
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: RCT with one active group and a control (placebo) group
Primary purpose: TREATMENT

Brief summary: While thoracic epidural could control incisional pain after thoracotomy, an excruciating ipsilateral shoulder pain happens post thoracotomy and could affect up to 85% of thoracotomy patients. It is often difficult to manage and relatively resistant to opioids. The investigators postulate that in the presence of a functioning thoracic epidural, intrapleural bupivacaine administered through the chest tube could be effective in reducing post thoracotomy ipsilateral shoulder pain.


Eligibility criteria: Inclusion Criteria:

* Male and Female, between 18 and 80 years, ASA 1-3, Scheduled for open thoracotomy

Exclusion Criteria:

* ASA \>3, morbid obesity BMI\>40, Previous cardiac or ipsilateral thoracic surgery, Renal or hepatic failure, anemia, allergy to local anesthetics, contraindications to receive regional anesthesia, patient refusal, reiteration due to complication

Primary outcomes:
measure: Change in VAS scores
timeFrame: from 0 hour to 24 hour
Secondary outcomes:
measure: Forced Vital Capacity
timeFrame: from 0 hour to 48 hour
measure: Total epidural infusion
timeFrame: from 0 hour to 48 hour
measure: Co-analgesia consumption
timeFrame: from 0 hour to 48 hour
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Montreal General Hospital
state: Quebec
Study officials:
References:
Clinical trial NCT05246904: Validating a Self-fitting Hearing Aid
Official title: Validating a Self-fitting Hearing Aid
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing and Vision Loss
Keywords: hearing aids, self-fitting
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2022-02-18
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will be randomly assigned to arm 1 (audiologist fit) or arm 2 (self fit) first. After 2-3 weeks they will be tested and then assigned to the opposite arm.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Eargo, Inc. has developed a hearing aid that contains self-fitting gain software that allows adults with mild-to-moderate hearing loss to test their hearing sensitivity and program hearing aids to match their measured hearing loss. Traditionally, hearing aids are custom programmed by a hearing health professional based on a professional hearing test. This technology has the potential to improve affordability and accessibility of hearing aids for adults with mild-to-moderate hearing loss. We propose to validate Eargo's self-fitting software in a clinical trial comparing self-fitting hearing aid outcomes to the same hearing aid fit by a professional following usual clinical best practice for fitting hearing aids.

Detailed description: The study will recruit 30-50 adults age 18 and over with mild-to-moderate hearing loss in both ears. We will aim to recruit a sample with roughly equal number of males and females and new and experienced hearing aid users (defined by any hearing aid use within the previous 6 months). Hearing loss will be measured using the results of a standard clinical hearing test.

We will use a within-subject, crossover design in which all participants will complete both field trial hearing aid conditions (self-fit and clinically fit hearing aids). The order of the field trials will be randomized across participants to account for any potential order effects. After each field trial, participants will visit the lab to complete study outcome measures, including hearing aid benefit, subjective sound quality, and speech in noise intelligibility testing.

Eligibility criteria: Inclusion Criteria:

* mild to moderate hearing loss ability to follow written directions,

Exclusion Criteria:

* inability to use software during first visit

Primary outcomes:
measure: Abbreviated profile of hearing aid benefit
timeFrame: 2-3 weeks
measure: Speech in noise test, AZ Bio sentences
timeFrame: Immediately after fitting
Secondary outcomes:
measure: Subjective sound quality rating
timeFrame: 2-3 weeks
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
References:
Clinical trial NCT00071604: Medication Adherence in Older People With Psychosis
Official title: Medication Adherence in Older Psychotic People
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Psychotic Disorders
Schizophrenia
Lead sponsor: Veterans Medical Research Foundation
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2003-10-30
Enrollment: 240
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This study will determine whether Medication Adherence Therapy (MAT) can improve medication adherence and lower the risk of rehospitalization in older patients with psychosis.

Detailed description: Psychoses are among the most common and serious psychiatric disorders. Currently, the most effective treatment for psychoses involves the use of antipsychotic or neuroleptic medications. Unfortunately, pharmacologic regimens often do not achieve their goals because of poor medication adherence. Nonadherence to antipsychotic treatment is a considerable public health problem that leads to myriad clinical and economic burdens, including psychotic relapse, increased clinic and emergency room visits, and rehospitalization.

Participants in this study are randomly assigned to receive either MAT or supportive treatment for 12 weeks. MAT is given in 15 sessions and consists of motivational interviewing, education, and social skills and behavior modification. Individual MAT sessions are held in Weeks 1 and 12; small group sessions take place in Weeks 2 through 11. Three monthly booster group sessions begin in Week 16. Participants are assessed at baseline and at 3, 6, and 12 months. Medication adherence, psychopathology, quality of life, medication side effects, health beliefs, and functioning are assessed.

Eligibility criteria: Inclusion Criteria:

* DSM-IV criteria for schizophrenia or schizoaffective disorder
* Outpatient status at the time of enrollment
* Currently prescribed maintenance treatment with antipsychotic medication (typical or atypical, oral or depot)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Division of Geriatric Psychiatry Center (University of California, San Diego)
state: California
Study officials:
affiliation: VA San Diego Healthcare System & University of California, San Diego
name: Jonathan Lacro, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01274104: A Pilot Study on the Effect of Vitamin D Treatment in Patients With Statin-Associated Myalgia
Official title: A Pilot Study on the Effect of Vitamin D Treatment in Patients With Statin-Associated Myalgia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Hyperlipidemia
Keywords: statin-related myalgia
high cholesterol
Lead sponsor: Avera McKennan Hospital & University Health Center
Sponsor class: OTHER
First posted: 2011-01-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to measure the effect vitamin D has in alleviating muscle pain or aches that may be caused by taking certain medications for treating high cholesterol.

Detailed description: Participation in this study will consist of at least two study visits, expected to occur over a period of up to four weeks. Study-related medication will be provided at no cost to participants. Participants will receive either Vitamin D or placebo (sugar pill).

Eligibility criteria: Inclusion Criteria:

* Men and women who are between the ages of 18 and 88 years old
* A muscle symptom defined as any of the following: Myalgia (muscle aches with normal CK); Myopathy (muscle aches with increased CK up to 5 times above the upper limit of normal); or Myopathy for the purpose of further evaluation (muscle aches with increased CK up to 5 times the upper limit of normal)

Exclusion Criteria:

* Women who are pregnant, breastfeeding or planning to become pregnant
* Morbidly obese with a BMI \>40 kg/m2
* Travel to southern states, areas near the Equator, etc., or use of artificial tanning beds, such that study participants have increased sunlight/UV rays exposure in the past 30 days or at any point during the trial
* Currently (within the last 2 weeks) using any of the following supplements: Vitamin D-3 (Cholecalciferol) of more than 400 IU orally daily, which would not exclude typical multi-vitamin use; Vitamin D-2 (Ergocalciferol); Calcitriol; or Coenzyme Q10
* Documented to be hyperglycemic or laboratory results show hyperglycemia prior to randomization
* Renal dysfunction defined as glomerular filtration rate less than 60 mL/min.
* Documented to have parathyroid abnormalities or parathyroid hormone laboratory results show the study participant is outside of the normal limits

Primary outcomes:
measure: Brief Pain Inventory value
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Sioux Falls
country: United States
facility: Avera Research Institute
state: South Dakota
Study officials:
affiliation: Avera McKennan Hospital & University Health Center
name: Wael Eid, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00908804: Open Versus Laparoscopic Appendectomy
Official title: Open Versus Laparoscopic Appendectomy in Suspected Acute Appendicitis - a Prospective Randomised Clinical Trial With With 10-Year Follow-up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Appendicitis
Keywords: acute appendicitis
Lead sponsor: North Karelia Central Hospital
Sponsor class: OTHER
First posted: 2009-05-27
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The aim of this prospective randomized trial is to compare the feasibility of open with laparoscopic appendectomy in suspected acute appendicitis. The investigators especially focused on the postoperative recovery and long-term complications.


Eligibility criteria: Inclusion Criteria:

* age over 15 years
* suspected acute appendicitis
* suitability for laparoscopy

Exclusion Criteria:

* patients refusal to participate
* lack of a laparoscopic surgeon

Primary outcomes:
measure: Complication; wound problem or other primary complication
Secondary outcomes:
Other outcomes:
Locations:
city: Joensuu
country: Finland
facility: North Karelia Central Hospital, Clinic of Surgery
Study officials:
References:
citation: Kouhia ST, Heiskanen JT, Huttunen R, Ahtola HI, Kiviniemi VV, Hakala T. Long-term follow-up of a randomized clinical trial of open versus laparoscopic appendicectomy. Br J Surg. 2010 Sep;97(9):1395-400. doi: 10.1002/bjs.7114.
Clinical trial NCT03660904: A Comparison Between Home-made Vitrification & Thawing Media and a Commercially Available Brand on Blastocyst
Official title: A Comparison Between Home-made Vitrification & Thawing Media and a Commercially Available Brand on Blastocyst Survival, Expansion and Implantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Blastocyst Disintegration
Keywords: vitrification
blastocysts
home-made media
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2018-09-07
Enrollment: 74
Sex: FEMALE
Minimum age (years): 22
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group 1 blastocysts were vitrified with the Vit (home made) HM according to shady grove protocol using open system on cryotop vit. device and thawed with gradual thawing technique using HM thawing media according to Kuwayama protocol.

Group 2 blastocysts were cryopreserved with the Global Fast Freeze Kit using open system on cryotop vit. device and thawed using Global fast thaw kit. Blastocysts were assessed immediately for survival, subsequently cultured for 6-8 h, assessed for survival and expansion, then transferred and the percentages of Positive hCG, clinical pregnancy, implantation, multiple pregnancy and abortion were recorded.
Primary purpose: BASIC_SCIENCE

Brief summary: This study was conducted to evaluate and compare cryo-survival, re-expansion, and implantation rates of Day 5/6 human blastocysts that were vitrified with home-made media (HM) according to (Shady grove protocol) and warmed with gradual Thawing HM according to (Kuwayama protocol)with Global Fast Freeze/Thaw Kits (LifeGlobal, Canada).

Detailed description: Group 1 blastocysts were vitrified with the Vit HM according to shady grove protocol using open system on cryotopvit. device and thawed with gradual thawing technique using HM according to Kuwayama protocol. Group 2 blastocysts were cryopreserved with the Global Fast Freeze Kitusing open system on cryotopvit. device and thawed using Gobal fast thaw kit. Blastocysts were subsequently cultured for 6-8 h, assessed for survival and expansion, then transferred and the percentages of Positive hCG, clinical pregnancy, implantation, multiple pregnancy and abortion were recorded.

Eligibility criteria: Inclusion Criteria:

* age of the patients 22-37
* All vitrified \& thawed blastocyst.
* unexplained cases or ovarian factors for infertility.

Exclusion Criteria:

* extremes of age
* cases of uterine factor
* endometriosis

Primary outcomes:
measure: blastocyst immediate survival
timeFrame: 0 hour at time of thawing
Secondary outcomes:
measure: pregnancy rate
timeFrame: 2 weeks after transfer
measure: live birth rate
timeFrame: 9 months
measure: Blastocyst survival at 6 hours
timeFrame: 6 hours after thawing
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06869304: The Effect of Steep Trendelenburg Position on Neurocognitive Functions in Robotic Radical Prostatectomy Cases
Official title: Examining the Effect of Steep Trendelenburg Position on Neurocognitive Functions With MoCA Test in Robotic-assisted Radical Prostatectomy Surgeries.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Neurocognitive Disorder
Robotic Assisted Laparoscopic Radical Prostatectomy
Near Infrared Spectroscopy
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2025-03-11
Enrollment: 56
Sex: MALE
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients aged 65 years and older with ASA II-III risk scores, undergoing robotic radical prostatectomy

Brief summary: The aim of this study is to evaluate the effects of the steep Trendelenburg position in robotic prostatectomy cases, where anesthesia depth is monitored using BIS and cerebral perfusion is tracked with NIRS, and to determine the incidence of neurocognitive dysfunction using the MoCA test in the postoperative period.

Steep Trendelenburg position and CO₂ pneumoperitoneum during robotic radical prostatectomy lead to significant changes in intracranial pressure and cerebral oxygenation, which may contribute to postoperative neurocognitive dysfunction (POCD). Monitoring anesthesia depth with Bispectral Index (BIS) and cerebral perfusion with Near-Infrared Spectroscopy (NIRS) may help detect early neurocognitive changes, and MoCA test assessments will reveal a measurable decline in cognitive function postoperatively.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 65 years
* ASA II-III risk score
* Patients scheduled for robotic radical prostatectomy
* Patients who voluntarily agree to participate

Exclusion Criteria:

* Age \< 65 years
* History of neurological or psychiatric disorders
* Inability to undergo robotic surgery
* Conversion to open prostatectomy during surgery
* Patients who do not consent to participate

Primary outcomes:
measure: MoCA
timeFrame: preoperatively
measure: MoCA
timeFrame: day 1
Secondary outcomes:
measure: NIRS
timeFrame: intraoperatively
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara City Hospital Bilkent
Study officials:
References:
Clinical trial NCT00817804: Cross-over Comparison of the V60 System to Other Bi-Level Noninvasive Ventilators
Official title: Cross-over Comparison of the V60 System to Other Bi-Level Noninvasive Ventilators for Pediatric Patients With Respiratory Failure or Respiratory Insufficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Insufficiency
Respiratory Failure
Keywords: noninvasive ventilation
Lead sponsor: Respironics, California, Inc.
Sponsor class: INDUSTRY
First posted: 2009-01-06
Enrollment: 3
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare a new noninvasive ventilator to existing ventilators already used for patient care.

Detailed description: This study compares the Respironics California V60 Mask ventilator to conventional noninvasive ventilators in a cross-over study with the patient as his/her own control.

Eligibility criteria: Inclusion Criteria:

* Age \> 7 years and \< 18 years
* Weight \> 20 kg (44 lbs)
* Respiratory failure or respiratory insufficiency
* Ability to cooperate with the investigators
* Designated adult able to provide Informed Consent

Exclusion Criteria:

* An endotracheal tube or tracheostomy in place
* Hemodynamically instability
* Prolonged apnea
* Inability to maintain the airway
* A recent history of cardiac and or respiratory arrest
* Acute hemorrhage
* Multiple organ system failure
* Undrained pneumothorax
* High risk for aspiration
* Metastatic or terminal cancer
* Do-not-resuscitate orders
* Inability to clear respiratory secretions
* Inability to fit a mask
* Facial surgery, trauma, or deformity
* Upper gastrointestinal or airway surgery
* Pregnancy
* Refractory delirium
* PaO2 \< 50 mmHg on present settings
* Designee unable or unwilling to provide Informed Consent

Primary outcomes:
measure: Breathing Comfort
timeFrame: 30 minutes
Secondary outcomes:
measure: Saturation of Arterial Oxygen
timeFrame: 30 minutes
measure: Respiratory Rate
timeFrame: 30 minutes
measure: Minute Ventilation
timeFrame: 30 minutes
measure: Heart Rate
timeFrame: 30 minutes
measure: Blood Pressure
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: GF-221 Health Sciences Centre
state: Manitoba
Study officials:
affiliation: University of Manitoba, Winnipeg, Manitoba, Canada
name: Steven Mink, MD
role: PRINCIPAL_INVESTIGATOR
References: