louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04362384: Topical Vitamin E Ovules for the Treatment of Hemorrhoids
Official title: Topical Endorectal Vietamin E Ovules for the Treatment of Grade 2 and 3 Hemorrhoids
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Bleeding Anal
Pain
Stings
Lead sponsor: Hospital General Universitario Elche
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 120
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: Patients with hemorrohoids grade II and III were included. Patients were randomized into 2 groups:

* Experimental group: Patients will receive a treatment with vitamin E ovules, which must be placed inside the annus
* Control group: Patients will receive a treatment with corticoid ointment, with endoanal application

Bleeding, pain and stinging will be evaluated 14 days after beginning the treatment.

Detailed description: Patients with hemorrohoids grade II and III were included.

Patients were randomized into 2 groups:

* Experimental group: Patients will receive a treatment with vitamin E ovules, which must be placed inside the annus. 1 ovule must be inserted daily during 14 days.
* Control group: Patients will receive a treatment with prednisolone ointment, with endoanal application 3 times per day during 14 days.

Bleeding, pain and stinging will be evaluated 14 days after beginning the treatment. Quantification of pain will be performed following a visual analogic scale ranging from 0 (absence of symptoms) to 100 (unbearable symptoms).

Eligibility criteria: Inclusion Criteria:

* Grade II and III hemorrhoids

Exclusion Criteria:

* Grade I or IV hemorrhoids
* Patients with previous anal surgeries
* Patients having received previous pharmacological treatments for hemorrhoids

Primary outcomes:
measure: % of patients with Bleeding
timeFrame: 14 days after beginning the treatment
Secondary outcomes:
measure: Anal pain assessed by Visual Analogic Scale
timeFrame: 14 days after beginning the treatment
measure: % of patients with Stinging
timeFrame: 14 days after beginning the treatment
Other outcomes:
Locations:
Study officials:
affiliation: Garcilaso Clinic
name: Jaime Ruiz Tovar Polo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05882084: Oral Supplementation of Astaxanthin on Skin Photoaging, Hydration and Elasticity
Official title: Double Blind Placebo Controlled Oral Supplementation of Astaxanthin on Skin Photoaging, Hydration and Elasticity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Photoaging
Keywords: Carotenoid
Astaxanthin
Skin
Hydration
Elasticity
Lead sponsor: Integrative Skin Science and Research
Sponsor class: INDUSTRY
Collaborators: name: AstaReal
First posted: 2023-05-31
Enrollment: 24
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Astaxanthin vs Placebo
Primary purpose: TREATMENT

Brief summary: This study is a double-blind placebo controlled study to assess whether oral astaxanthin can improve skin hydration, skin elasticity, improve skin pigmentation, and reduce facial redness.


Eligibility criteria: Inclusion criteria:

* Females who are 30 to 55 years of age
* Half of the women will have Fitzpatrick skin type 1-3 and the other half of the women will have Fitzpatrick skin type 4-6

Exclusion criteria:

* Individuals with a known allergy to astaxanthin or other carotenoids (such as zeaxanthin, lutein, lycopene).
* Individuals who are unwilling to discontinue carotenoid supplementation for at least 1 month prior to enrollment
* Individuals unwilling to restrict intake of foods like shrimp, salmon, mangos, carrots, and tomatoes during the study.
* New supplementation within 4 weeks with tocopherol
* Individuals who are unwilling to stay consistent with a facial cleansing regimen.
* Those who are unwilling to discontinue topical hydroquinone, retinoid or benzoyl peroxide for 2 weeks prior to enrollment
* Individuals who are pregnant or breastfeeding.
* Individuals who have changed any of their hormonal based contraception within 3 months prior to joining the study.
* Current tobacco smoker or a tobacco smoking history of greater than 10 pack-years

Primary outcomes:
measure: Skin Hydration
timeFrame: 8 weeks
measure: Skin elasticity
timeFrame: 8 weeks
Secondary outcomes:
measure: Facial pigmentation
timeFrame: 8 weeks
measure: Facial redness
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Integrative Skin Science and Research
state: California
Study officials:
affiliation: Integrative Skin Science and Research
name: Raja Sivamani, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00909584: Study of Ezatiostat (Telintra Tablets) for Treatment of Severe Chronic Neutropenia
Official title: Phase 2 Randomized Study of Ezatiostat Hydrochloride (Telintra™, TLK199 Tablets) for Treatment of Severe Chronic Neutropenia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Severe Chronic Neutropenia
Keywords: Hematology
Neutropenia
SCN
Severe Chronic Neutropenia
Idiopathic
Telintra
ezatiostat hydrochloride
ezatiostat
TLK199
Glutathione
Glutathione analog
Glutathione Transferase
Glutathione Transferase inhibitor
Glutathione Transferase P1-1 inhibitor
GSTp1-1 inhibitor
Apoptosis
Differentiation
Enzyme inhibitor
Lead sponsor: Telik
Sponsor class: INDUSTRY
First posted: 2009-05-28
Enrollment: 9
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: This is a multicenter Phase 2 randomized parallel-group study to determine the effect of Telintra treatment on severe chronic neutropenia. Patients will be randomized to Telintra or enter an observation period with an option to crossover to Telintra treatment in a 1:1 allocation.


Eligibility criteria: Inclusion Criteria:

* Confirmed Idiopathic Severe Chronic Neutropenia
* ECOG performance status of 0-2
* Adequate liver and renal function
* Adequate Red Blood Cell and Platelet counts

Exclusion Criteria:

* Prior treatment of SCN
* Non-Idiopathic types of SCN, ie. cyclic, congenital
* History of chromosomal abnormalities, myelodysplasia, hematologic malignancy, aplastic anemia, systemic lupus erythematosus, rheumatoid arthritis (Felty's syndrome), or other collagen diseases, and drug-induced neutropenia, autoimmune neutropenia
* Use of granulocyte colony stimulating factors (G-CSF), glucocorticoids, gamma globulin, lithium or investigational drug(s) within one month of enrollment
* History of bone marrow transplantation or stem cell support

Primary outcomes:
measure: Objective absolute neutrophil count (ANC) response rate
timeFrame: 18 Months
Secondary outcomes:
measure: Incidence of infections, oropharyngeal ulcers and antibiotic use
timeFrame: 18 Months
measure: Incidence and duration of hospitalizations
timeFrame: 18 Months
measure: FACT-N quality of life assessment
timeFrame: 18 Months
measure: Safety assessments
timeFrame: 18 Months
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Center for Cancer and Blood Disorders
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan Hospital
state: Michigan
city: San Antonio
country: United States
facility: Cancer Care Centers of South Texas
state: Texas
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
Study officials:
affiliation: Telik
name: Gail Brown, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01346384: Time - Related Cuff Pressure and Volume of the Laryngeal Tube With the Use of Nitrous Oxide
Official title: Time - Related Cuff Pressure and Volume of the Laryngeal Tube With the Use of Nitrous Oxide
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adult Disease
Keywords: intracuff pressure
laryngeal tube
nitrous oxide
Lead sponsor: Prince of Songkla University
Sponsor class: OTHER
First posted: 2011-05-03
Enrollment: 75
Sex: ALL
Minimum age (years): 15
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with general anesthesia

Brief summary: The purpose of this study is to investigate the time-related intracuff pressure and volume change (which reflects the pharyngeal pressure) of the LT during anesthesia with N2O.

Detailed description: Background : The laryngeal tube airway (LT) is an extraglottic airway device with a proximal and distal conical cuff designed to secure a patient's airway during either spontaneous breathing or controlled ventilation. Application of this device with the use of N2O may be related to the ischemic change of the oropharyngeal mucosa. The objective of this study was to investigate the time-related intracuff pressure and volume change (which reflects the pharyngeal pressure) of the LT during anesthesia with N2O.

Methods : Seventy-five patients were studied with the use of LT size 4. N2O (66%) and isoflurane were used to maintain anesthesia. Initial intracuff pressure and volume were recorded for airway sealing during ventilation. Time-course changes of the intracuff pressure followed by recording every 10 min. If the intracuff pressure reached 100 cmH2O, the cuff was deflated to the initial intracuff pressure and the volume of deflated air and postoperative airway complications were recorded.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologist physical status I or II
* Undergoing elective orthopedic surgery and surgery of breast under general anesthesia with an expected duration of 60 min or more

Exclusion Criteria:

* Height was \< 155 or \>180 cm (for the use of laryngeal tube size 4)
* Body mass index ≥35 kg/m2
* Preexisting laryngotracheal disease
* Risk of pulmonary aspiration of gastric contents.

Primary outcomes:
measure: intracuff pressure
timeFrame: 1-4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Hatyai
country: Thailand
facility: Songklanagarind Hospital
state: Songkhla
Study officials:
References:
Clinical trial NCT04955184: Comparing Cardiac Output Measurements Using a Wearable, Wireless, Non-invasive PPG-Based Device to a Swan Ganz Catheter
Official title: Comparing Cardiac Output Measurements Using a Wearable, Wireless, Non-invasive PPG-Based Device to a Swan Ganz Catheter During Ambulatory Assessment of CHF Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Output, Low
Cardiac Output, High
Congestive Heart Failure
Keywords: Non-Invasive Monitoring
Cardiac Output
Lead sponsor: Biobeat Technologies Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Hadassah Medical Organization
First posted: 2021-07-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients from both sexes with CHF arriving for an ambulatory assessment using a Swan-Ganz catheter in the Medical Center's Cath-lab.

Brief summary: Invasive pulmonary capillary wedge pressure measurements using a Swan-Ganz catheter (SGC) is considered the gold standard for cardiac output (CO) monitoring. In this prospective study, we will compare CO measurements between a PPG-based wearable monitor and a SGC in ambulatory CHF patients.


Eligibility criteria: Inclusion Criteria:

* Patients with CHF

Exclusion Criteria:

* Pregnant women
* Pediatric patients
* Inability to sign an informed consent form

Primary outcomes:
measure: Comparison of cardiac output obtained by a non-unvasive device to the invasive method
timeFrame: 2-4 hours per patient
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: The Hadassah Ein Kerem Medical Center
Study officials:
affiliation: The Institute for Research in Military Medicine
name: Dean Nachman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02297984: Serum Neuroglobin and HIF-1α in Acute Ischemic Stroke
Official title: Changes of Serum Neuroglobin and HIF-1α Concentrations in Early-phase of Acute Ischemic Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Ischemic Stroke
Keywords: Neuroglobin
HIF-α
Acute ischemic stroke
Prognosis
Lead sponsor: Shanghai 6th People's Hospital
Sponsor class: OTHER
First posted: 2014-11-21
Enrollment: 40
Sex: ALL
Minimum age (years): 42
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patient group comprised 24 male and 16 female. Their age ranged from 42 to 76 years. Locations of infarct, as evidenced by radiologic and neurologic symptoms or signs, included the territories of the middle cerebral artery (13 cases), the posterior cerebral artery (9 cases) the anterior cerebral artery (8 cases), vertebrobasilar area (7 cases), and watershed area (3 cases with cortical and subcortical low densities crossing typical vascular territories).

Brief summary: Neuroglobin has shown rich neuroprotective effects against cerebral ischemia and hypoxia, and therefore has the potential to impact outcomes after acute ischemic stroke. Hypoxia inducible factor (HIF)-1α is neuroprotective in several models of experimental brain injury and is increased in brain after acute cerebral infarction in humans and experimental animals.The investigators sought to examine the changes in serum neuroglobin and HIF-1α concentrations in patients with acute ischemic stroke during the initial 96-h period after stroke and assessed the relation between them and the relation of them to prognosis of such patients with acute ischemic stroke.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of acute ischemic stroke
* Admission within 12 hours

Exclusion Criteria:

* Lacunar infarction
* Cerebral hemorrhagic infarction
* Epilepsy or epileptic persons
* History of neurological diseases, myocardial infarction, renal and hepatic abnormalities and metabolic diseases
* Contraindications to antiplatelet treatments
* Serial blood samples could not be obtained

Primary outcomes:
measure: Modified Rankin Scale scores
timeFrame: 3 months
Secondary outcomes:
measure: Glasgow Outcome Scale scores
timeFrame: 3 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Sixth People's Hospital
Study officials:
affiliation: Shanghai 6th People's Hospital
name: Lixia Xue, M.D., Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05642884: Prehabilitation Feasibility Among Older Adults Undergoing Transplantation
Official title: Feasibility of a Prehabilitation Intervention Among Older Adults With Myeloma Receiving Autologous Stem Cell Transplant
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Myeloma
Keywords: Autologous Stem Cell Transplant
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2022-12-08
Enrollment: 30
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We plan to enroll a total of 30 patients, randomized 1:1 using permuted block algorithm stratified by sex and age (e.g. 60-70, \>70y), into intervention arm (home based prehabilitation) vs an attention control (dietary counseling) group.
Primary purpose: PREVENTION

Brief summary: This is a pilot feasibility trial among older adults (≥60y) scheduled to undergo Autologous Stem Cell transplantation at UAB. Participants will be randomized into either a prehabilitation program or an attention control group before their transplant. The primary outcomes will be feasibility and secondary outcomes include changes in physical function at the time of transplant and at 12 weeks follow up.

Detailed description: This is a pilot randomized trial of older adults 60y and above planned to undergo Autologous Stem Cell Transplant for Multiple Myeloma. Eligible participants will be randomized (like flipping a coin) to one of two study conditions: 1) an 8 week long home-based prehabilitation exercise program delivered using a telehealth format or 2) an 8-week long nutrition counseling (attention control group). Assessments will occur at baseline, post-intervention (during transplant) and at 12-weeks post-transplant. Investigators will assess the feasibility and acceptability of our program as well as preliminary impact of the program on physical functioning during these time-periods.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Multiple Myeloma
* Scheduled for ASCT at UAB within 10 weeks of study enrollment
* age at ASCT ≥60y

Exclusion Criteria:

* at high risk for impending pathologic fracture using Mirels score

Primary outcomes:
measure: Participation rate
timeFrame: 1 year
measure: Completion rate
timeFrame: 1 year
measure: Adherence rate
timeFrame: 1 year
measure: Acceptability
timeFrame: 1 year
Secondary outcomes:
measure: Change in Lower Extremity Physical Function
timeFrame: 1 year
measure: Change in Functional Exercise Capacity
timeFrame: 1 year
measure: Change in mobility
timeFrame: 1 year
measure: Change in functional status
timeFrame: 1 year
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Kirklin Clinic of UAB Hospital
state: Alabama
Study officials:
References:
Clinical trial NCT01585584: Triple-Therapy in Patients With HCV Genotype 3 Who Previously Failed Treatment
Official title: Triple-Therapy With PegInterferon α-2b + Ribavirin + Boceprevir in Patients With HCV Genotype 3 Who Previously Failed Treatment With PegInterferon α + Ribavirin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis C
Keywords: Boceprevir
Hepatitis C Genotype 3
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2012-04-26
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
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 test the potential antiviral efficacy of triple-combination therapy with Peginterferon α-2b + ribavirin + boceprevir (PRB) in patients with HCV genotype 3 who previously failed Peginterferon α + ribavirin (non-responders or relapsers).

Detailed description: i) Obtain preliminary information on the association between important baseline and on-treatment factors and SVR in this patient population. Variables to be examined may include gender, age, advanced fibrosis or cirrhosis (F3 or F4 estimated by Fibroscan), baseline viral load, RVR, wk 8 viral load, end-of-treatment viral response.

ii) Evaluate adverse events. iii) Evaluate viral resistance.

Eligibility criteria: Inclusion Criteria:

* Subjects will be eligible for the study if they meet the following inclusion criteria:

  1. 18 years of age or older
  2. Infected with HCV genotype 3 (mixed genotypes are NOT permitted)
  3. Have received at least 12 weeks of previous treatment with peginterferon-α + ribavirin
  4. Detectable serum HCV-RNA
  5. No significant co-morbid conditions
  6. Liver biopsy is not necessary
  7. Cirrhotic patients will be eligible to participate if Child-Pugh class A (maximum 15% of subjects)

Exclusion Criteria:

* Subjects will be excluded from participation in this study if the following conditions are present:

  1. Significant comorbidities: uncontrolled psychiatric conditions including severe depression, cardiovascular, respiratory, renal or metabolic conditions, active carcinoma.
  2. Active substance abuse within the past 12 months
  3. Co-infection with hepatitis B or HIV
  4. Decompensated cirrhosis (Child-Pugh class B or C)
  5. Significant cytopenia - any of the following: platelets \<80 x 109/L, neutropenia \<1.2 x 103/L, Hb \<120 g/l for men or 110 g/l for women
  6. Lack of informed consent
  7. Previous null-responders (\<2 log10 decrease at week 12 with previous PR therapy)

Primary outcomes:
measure: Sustained Virologic Response (SVR) at 24 Weeks Post Treatment
timeFrame: 24 weeks after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary Liver Unit
state: Alberta
Study officials:
affiliation: University of Calgary
name: Samuel Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00229502: Cognitive Effects of Immunomodulatory Drugs in MS
Official title: Comparison of the Cognitive Effects of Three Immunomodulatory Drugs in Relapsing-Remitting Multiple Sclerosis: A Longitudinal Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: EMD Serono
First posted: 2005-09-29
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Multiple sclerosis clinic

Brief summary: The purpose of this study is to examine and compare changes in the specific thinking skills of patients with RRMS who are receiving treatment with one of three immunomodulatory medications (Avonex, Copaxone, or Rebif).

Detailed description: In addition this study will compare the patients' personal view of how they are doing, any changes in physical disability, and the frequency and severity of relapses over the three year period.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of RRMS for at least one year,
* Currently on one of three immunomodulatory drugs (Avonex, Copaxone, or Rebif),
* Visual Acuity is 20/50 or better,
* patient has four color vision,
* Must have at least a high school education

Exclusion Criteria:

* History of head injury, drug/alcohol abuse, and/or psychiatric problems, -current diagnosis of a severe or lifethreatening disease other than MS,
* currently taking immunosuppressant medication,
* resides greater than 200 miles from the study site

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Sharon G Lynch, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Kansas Medical Center
name: Douglas R Denney, PhD
role: PRINCIPAL_INVESTIGATOR
References: