louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01243060: Effect of a Hypocretin/Orexin Antagonist on Neurocognitive Performance
Official title: Effect of a Hypocretin/Orexin Antagonist on Neurocognitive Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Keywords: Sleep Aid
Lead sponsor: Northern California Institute of Research and Education
Sponsor class: OTHER
Collaborators: name: U.S. Army Medical Research and Development Command
First posted: 2010-11-18
Enrollment: 203
Sex: ALL
Minimum age (years): 19
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: In recent years, there has been increased focus on cognitive side effects of sleep-inducing medications that may contribute to unusual behavior during unexpected awakenings during the night. Concerns regarding these side effects have led to a class Food and Drug Administration (FDA) warning for all sleep-inducing medications. Almorexant is an experimental sleep-inducing medication in a new class of medications that is being extensively developed by multiple pharmaceutical companies. Medications in this class block wake/arousal centers in the brain that function with proteins called hypocretins. The goal of this study is to evaluate the impact on cognitive performance of almorexant vs. zolpidem (an approved sleep aid) or placebo.

Detailed description: Up to 216 healthy volunteers will be enrolled to participate in the 10 day study. After screening procedures have been completed (at SFVAMC), Days 1 - 7 will take place in subjects' homes, where their sleep/wake activity will be monitored. Days 8 - 10 will take place at Moffitt Hospital. On Day 10, subjects will take one dose of either almorexant 100mg, almorexant 200mg, zolpidem 10mg, or placebo. Cognitive tests will be administered to subjects throughout Day 10. Subjects will return for follow-up safety labs within 5 - 12 days of dosing with study medication. Based on animal studies, it is anticipated that subjects who take almorexant will be less cognitively impaired than those who take zolpidem.

Eligibility criteria: To participate in the study, participants must:

* Be between the ages of 19 and 39
* Be in good physical health
* Be a good sleeper with consistent bedtimes and wake times
* Not have problems falling or staying asleep
* Be a non-smoker
* Meet our other study criteria

Primary outcomes:
measure: A comparison between dosing groups on performance on neurocognitive measures
timeFrame: Within a 7-hour window post dose.
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco Veterans Affairs Medical Center
state: California
Study officials:
affiliation: Northern California Institute of Research and Education
name: Thomas Neylan, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04108260: The Effectiveness of Recombinant Coagulation Factor IX With Recombinant Albumin (rIX-FP) in Severe Hemophilia B Patients
Official title: The Effectiveness of Recombinant Fusion Protein Linking Coagulation Factor IX With Recombinant Albumin (rIX-FP) in Severe Hemophilia B Patients Switching From Previous Factor IX Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hemophilia
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2019-09-30
Enrollment: 5
Sex: MALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The pivotal clinical data support prolonged dosing intervals of up to 14 days for routine prophylaxis in hemophilia B patients. The majority of adult and pediatric patients using Idelvion for routine prophylaxis had a median annualized spontaneous bleeding rate (AsBR) of 0.00. The majority (99%) of bleeding episodes were managed successfully with one or two infusions, and 94% of bleeds were controlled with only one infusion regardless of the cause or location.

The rationale for this study is to collect the effectiveness and safety data of severe hemophilia B patients treated with Idelvion following institutional standard of care. It is the aim of this study to extend the results of the clinical trial program to a broader hemophilia B population, and to compare with current alternative factor IX treatments in Taiwan.


Eligibility criteria: Inclusion Criteria:

* Male patients with age ≥ 20 years old
* Endogenous FIX activity ≤1 IU/dL,
* At least 50 exposure days (EDs) with FIX products,
* No detectable inhibitor to FIX or inhibitor history,
* Had a minimum of 2 nontrauma-induced bleeding episodes (any type or location) treated in the 6 months preceding study entry,
* The patient or patient's parents or legal authorized representative, as applicable, are capable to understand the study objectives and procedure, and sign the written consent,
* Accept that the supply of Idelvion might be stopped once the study is completed,
* Able to complete a diary during 12 months or 50 EDs, whichever comes first.

Exclusion Criteria:

* Currently participating in an interventional clinical trial,
* Known hypersensitivity to any FIX product or hamster protein,
* Known inhibitor to FIX or inhibitor history,
* With other comorbidities which are not suitable for this study, at investigator's discretion,
* Not able to compliant with the prophylactic treatment,
* Lacking previous treatment and bleeding records.

Primary outcomes:
measure: AsBR
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References:
Clinical trial NCT03402360: Virtual Reality Rehabilitation in Patients With Acquired Brain Injury
Official title: Effectiveness of Virtual Environment Rehabilitation in Patients With Acquired Brain Injury: Clinical Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acquired Brain Injury
Keywords: Virtual Reality
Rehabilitation
Acquired Brain Injury
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2018-01-18
Enrollment: 90
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: TREATMENT

Brief summary: The aim of the study is to investigate the effectiveness of motor and cognitive virtual environment rehabilitation on upper limb function in sub-acute patients after an acquired brain injury.


Eligibility criteria: Inclusion Criteria:

* Acquired Brain Injury within 1 month before the recruitment;
* Score between 0 and 3 at the Motor Arm subscore of the Italian version of the National Institutes of Health Stroke Scale (it-NIHSS);
* Score between 9 and 15 at the Glasgow Coma Scale for the traumatic brain injury Acquired Brain Injury.

Exclusion Criteria:

* Denial of informed consent;
* Visual deficits that interfere with the virtual reality rehabilitation;
* Score under 18 at the Mini Mental State Examination;
* Severe orthopedic deficit;
* Patients with pace maker;
* Patients with contraindication to undergo magnetic resonance;
* Pregnant women.

Primary outcomes:
measure: Change in Fugl-Meyer Upper Extremity (FMUE)
timeFrame: From Baseline (T0) to 3 weeks of rehabilitation (T1)
Secondary outcomes:
measure: Change in Action Research Arm Test (ARAT)
timeFrame: From Baseline (T0) to 3 weeks of rehabilitation (T1)
measure: Change in Functional Independence Measures (FIM)
timeFrame: From Baseline (T0) to 3 weeks of rehabilitation (T1)
measure: Change in Mini Mental State Examination (MMSE)
timeFrame: From Baseline (T0) to 3 weeks of rehabilitation (T1)
measure: Change in Montreal Cognitive Assessment (MoCA)
timeFrame: From Baseline (T0) to 3 weeks of rehabilitation (T1)
measure: Change in Beck Depression Inventory (BDI)
timeFrame: From Baseline (T0) to 3 weeks of rehabilitation (T1)
measure: Change in 36-Item Short Form Survey (SF-36)
timeFrame: From Baseline (T0) to 3 weeks of rehabilitation (T1)
Other outcomes:
measure: Change in Resting state functional MRI (fMRI)
timeFrame: From Baseline (T0) to 3 weeks of rehabilitation (T1)
Locations:
city: Milan
country: Italy
facility: IRCSS Ospedale San Raffaele
state: MI
Study officials:
References:
Clinical trial NCT06430060: The Clinical Investigation of Colgate Dual Zinc Toothpaste as Compared to Colgate Cavity Protection Toothpaste in Controlling Established Plaque and Gingivitis
Official title: The Clinical Investigation of Colgate Dual Zinc Toothpaste as Compared to Colgate Cavity Protection Toothpaste in Controlling Established Plaque and Gingivitis (A Threemonth Clinical Study)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Plaque, Dental
Gingivitis
Lead sponsor: Colgate Palmolive
Sponsor class: INDUSTRY
First posted: 2024-05-28
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Qualified subjects will be enrolled and randomized to either one of the two study groups described above based on their initial Plaque and Gingivitis scores. Subjects will be instructed to use the products according to the instructions provided. Subjects will return to the dental office for evaluation after three months of product use. All subjects will be followed for adverse events throughout the study.


Eligibility criteria: Inclusion Criteria:

* Subjects, ages 18-70, inclusive.
* Availability for the three-month duration of the clinical research study.
* Good general health.
* Minimum of 20 uncrowned permanent natural teeth (excluding third molars).
* Initial gingivitis index of at least 1.0 as determined by the use of the Loe and Silness Gingival Index.
* Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein Plaque Index (Turesky Modification).
* Signed Informed Consent Form

Exclusion Criteria:

* Presence of orthodontic bands.
* Presence of partial removable dentures.
* Tumor(s) of the soft or hard tissues of the oral cavity.
* Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone).
* Five or more carious lesions requiring immediate restorative treatment.
* Antibiotic use any time during the one month prior to entry into the study.
* Participation in any other clinical study or test panel within the one month prior to entry into the study.
* Dental prophylaxis during the past two weeks prior to baseline examinations.
* History of allergies to oral care/personal care consumer products or their ingredients.
* On any prescription medicines that might interfere with the study outcome.
* An existing medical condition which prohibits eating or drinking for periods up to 4 hours.
* History of alcohol or drug abuse.
* Pregnant or lactating subjects

Primary outcomes:
measure: Loe-Silness Gingival Index score
timeFrame: baseline, 2 week, 6 week, 3 month
measure: Quigley-Hein Plaque Index score
timeFrame: baseline, 2 week, 6 week, 3 month
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Dental Institute of Chengdu
state: Sichuan
Study officials:
affiliation: West China Dental Institute of Chengdu
name: Deyu Hu, DDS, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00481494: Personality Characteristics and Compliance With Antiglaucoma Medication
Official title: Personality Characteristics and Compliance With Antiglaucoma Medication
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Glaucoma
Keywords: Glaucoma
Drug compliance
Personality
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2007-06-01
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: OTHER

Brief summary: Personality traits may influence to the drug compliance in glaucoma patients.

Detailed description: In chronic diseases, especially asymptomatic at early stage, drug compliance has been reported as an important factor to control them. And personality traits are associated with the drug compliance. However, there was few study to consider this relationship. We want to find the association the personality characteristics and drug compliance in glaucoma patients.

Eligibility criteria: Inclusion Criteria:

* Chronic glaucoma
* Topical anti-glaucoma medications

Exclusion Criteria:

* Oral glaucoma medications

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University College of Medicine
Study officials:
affiliation: Department of Ophthalmology, Yonsei University College of Medicine
name: Chan Yun Kim, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT06591494: The Efficacy of Quadruple Therapy Containing Sodium Bicarbonate as the Primary Treatment for Helicobacter Pylori Infection
Official title: The Efficacy of Quadruple Therapy Containing Sodium Bicarbonate as the Primary Treatment for Helicobacter Pylori Infection
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Helicobacter Pylori Infection
Keywords: Helicobacter pylori
Sodium Bicarbonate
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 855
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn the efficacy of sodium bicarbonate-containing quadruple therapy as the primary treatment for Helicobacter pylori infection. The main questions it aims to answer are:

Can sodium bicarbonate replace bismuth or clarithromycin in the classic quadruple therapy for the primary treatment of Helicobacter pylori infection? What is the safety and cost-effectiveness of sodium bicarbonate replacing bismuth or clarithromycin in the classic quadruple therapy for the primary treatment of Helicobacter pylori infection?

Researchers will compare sodium bicarbonate replacing bismuth or clarithromycin in the classic quadruple therapy to see the efficacy of sodium bicarbonate as an alternative to bismuth or clarithromycin in the classic quadruple therapy for the primary treatment of Helicobacter pylori infection.

Participants will： Take Helicobacter pylori treatment drugs for 14 days Recheck 13C-UBT or 14C-UBT breath test 6-8 weeks after eradication treatment Incidence of adverse reactions (AEs) and patient compliance


Eligibility criteria: Inclusion Criteria:

* Aged 18-65 years, no history of eradication therapy;
* Diagnosed with Helicobacter pylori infection by one or more of the following methods: gastric mucosal histochemical staining, tissue culture, 14C-UBT, 13C-UBT and/or fecal antigen;
* Patients with warning symptoms, family history of gastric cancer or over 40 years old should undergo endoscopic examination before eradication therapy;
* Voluntarily participate in clinical trials and sign informed consent.

Exclusion Criteria:

* Use of antibiotics or bismuth within 4 weeks before enrollment, or use of acid suppressants (including H2RA, PPI or P-CAB) within 2 weeks;
* Active peptic ulcer with complications such as bleeding, perforation or obstruction;
* History of esophagectomy or gastrectomy;
* Allergy to any study drug;
* Pregnancy or lactation;
* History of alcoholism or drug abuse;
* Mental illness;
* Incapacity for civil conduct.

Primary outcomes:
measure: Helicobacter pylori eradication rate
timeFrame: 6-8 weeks after eradication treatment
Secondary outcomes:
measure: Incidence of adverse reactions (AEs)
timeFrame: One month after finishing with therapy
measure: Compliance of patients
timeFrame: One month after finishing with therapy
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03232294: Fetal Front-abdominal Wall Thickness and Perinatal Outcome
Official title: Effect of Fetal Front-abdominal Wall Thickness on Birth Weight and Perinatal Outcome at 24-26. Gestational Weeks
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fetal Macrosomia
Abdominal Wall Mass
Perinatal Problems
Keywords: fetal macrosomia
fetal abdominal wall thickness
subcutaneous adipose tissue
Lead sponsor: Kayseri Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2017-07-27
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 96 women with low risk pregnancy coming to our clinic for a routine antenatal examination in 26-28th gestational weeks were included to this study

Brief summary: Abnormal fetal development such as macrosomia can cause some complications on both fetus and mother.The measurement of fetal anterior abdominal wall thickness (FAWT) is an easy examination that it can be obtained during an examination of a pregnant woman by ultrasound. Macrosomia for fetus can lead to some morbidities. It can affect perinatal outcome and increase childbirth complications and operative birth. There are some studies scrutinizing the relationship between FAWT and diabetes in the literature. However there are few studies which scrutinize effect of FAWT on both abnormal fetal development and adverse perinatal outcomes in non-diabetic pregnancies and non high risk pregnancies. Hence the investigators wonder if FAWT can anticipate birth-weight or macrosomic infant or perinatal outcome regarding with macrosomia in the second trimester.


Eligibility criteria: Inclusion Criteria:

A total of 96 women with low risk pregnancy coming to our clinic for a routine antenatal examination in 26-28th gestational weeks were included to this study and performed 75 gr- oral glucose tolerance test (OGTT).

Exclusion Criteria:

The participants with a positive 75-g OGTT were excluded. Additionally those following criteria were accepted as the exclusion criteria of this study: hypertension, preeclampsia, diabetes, fetal distress, fetal anomaly, multiple pregnancy, preterm labor, preterm premature rupture of membrane, placenta previa, polyhydramnios and intrauterine fetal growth restriction.

Primary outcomes:
measure: The relationship between fetal abdominal wall thickness and macrosomia
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Kayseri Education and Research Hospital
name: YUSUF MADENDAG
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00898794: Effect of Bevacizumab and VEGF on Platelet Clustering in Patients Who Are Receiving Bevacizumab for Cancer
Official title: Influence of Bevacizumab and VEGF on Platelet Aggregation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Unspecified Adult Solid Tumor, Protocol Specific
Unspecified Childhood Solid Tumor, Protocol Specific
Keywords: unspecified adult solid tumor, protocol specific
unspecified childhood solid tumor, protocol specific
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2009-05-12
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about the effect of bevacizumab and VEGF on platelet clustering.

PURPOSE: This research study is looking at the effect of bevacizumab and VEGF on platelet clustering in patients with cancer who are receiving bevacizumab.

Detailed description: OBJECTIVES:

* To determine the influence of bevacizumab on platelet aggregation in patients receiving bevacizumab for cancer.
* To determine the influence of VEGF on platelet aggregation.
* To determine the influence of VEGF or bevacizumab on cyclooxygenesis.
* To determine if the sequence of medication plays a role in platelet aggregation.

OUTLINE: Blood samples are collected before and after bevacizumab infusion. Samples are analyzed for measurements of platelet aggregation, coagulation parameters, and endothelial activation (e.g., fibrin fragment F1 and 2, thrombin and antithrombin complex, soluble P-selectin, Von Willebrand factor and factor VIII, tissue factor, and endothelin 1).

Eligibility criteria: DISEASE CHARACTERISTICS:

* Receiving bevacizumab for cancer

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

Primary outcomes:
measure: Influence of bevacizumab on platelet aggregation
measure: Influence of VEGF on platelet aggregation
measure: Influence of VEGF or bevacizumab on cyclooxygenesis
measure: Correlation between medication sequence and platelet aggregation
Secondary outcomes:
Other outcomes:
Locations:
city: Chur
country: Switzerland
facility: Kantonsspital Graubuenden
Study officials:
affiliation: Kantonsspital Graubuenden
name: Roger von Moos, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00364494: Hemodilution and Outcome in Cardiac Surgery
Official title: Effect of Moderate Hemodilution During Cardiopulmonary Bypass on Postoperative Outcome Following Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Kidney Failure
Intraoperative Complications
Keywords: Hematocrit
Hemodilution
Blood Transfusion
Cardiopulmonary Bypass
Multiple Organ Failure
Surgery, Cardiac
Kidney Failure
Cardiac Surgical Procedures
Lead sponsor: Università Vita-Salute San Raffaele
Sponsor class: OTHER
First posted: 2006-08-15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: An hematocrit of 21-25% is supposed to perform the best organ protection during cardiopulmonary bypass for cardiac surgery.

The investigators want to establish the best timing for a transfusion (in patients with a predicted low hematocrit during cardiopulmonary bypass) and the efficacy of preprocedural hemodilution (in patients with a predicted high hematocrit during cardiopulmonary bypass) in patients undergoing cardiac surgery.


Eligibility criteria: Inclusion Criteria:

* Undergoing cardiac surgery

Exclusion Criteria:

* Age \< 18 years old
* Not signing written consent
* Age \< 65 years old (subgroup 1)
* Emergency, aortic stenosis, main left coronary stenosis (subgroup 2)

Primary outcomes:
measure: renal function
Secondary outcomes:
measure: other organ damage
measure: prolonged mechanical ventilation, Intensive Care Unit (ICU) and hospital stay
measure: sepsis
measure: exitus
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia
Study officials:
affiliation: Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia
name: Giovanni Landoni, MD
role: STUDY_DIRECTOR
affiliation: Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia
name: Giuseppe Crescenzi, MD
role: PRINCIPAL_INVESTIGATOR
References: