louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02940236: Gastric Volumes After Oral Multimodal Analgesia in the Pre-operative Setting: A Prospective Case Series
Official title: Gastric Volumes After Oral Multimodal Analgesia in the Pre-operative Setting
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: General Surgery
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2016-10-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients scheduled for undergo surgical procedure

Brief summary: To assess possible risk of aspiration with pre-operative oral medications taken with "sips" of water (100ml).


Eligibility criteria: Inclusion Criteria:

* Patients able to take prescribed oral multimodal analgesia as per standard of care

Exclusion Criteria:

* BMI \> 40

Primary outcomes:
measure: Oral multimodal analgesia and gastric volume
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
Study officials:
References:
Clinical trial NCT04809636: Evaluating the Impact of Incentives on Clinical Trial Participation
Official title: Evaluating the Impact of Incentives on HIV Related Clinical Trial Participation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hiv
Aging
Incentives
Keywords: hiv
aging
incentives
Lead sponsor: University of California, Riverside
Sponsor class: OTHER
Collaborators: name: University of South Florida
First posted: 2021-03-22
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We will recruit patient partners, biomedical HIV researchers and IRB members/bioethicists involved in HIV research and patient partners with HIV co-morbidities (depression, heart disease, arthritis). For the patient populations, we will target men (including MSM) and women aging with HIV, cis and transgender women, and youth (age 18+) of color, but participation will be open to everyone over 18 years of age living with HIV who speaks English and live in the United States.

Brief summary: The objective of this study is to investigate the impact of incentives on clinical trial participation. 1) characterize key stakeholders' views on and assessment of incentives, 2) reach consensus among stakeholders on the factors to be considered when choosing incentives and their relative importance, 3) pilot test using vignettes for incentive decision making. We hypothesize that potential study participants make trade-offs regarding the characteristics of a research study when deciding whether to volunteer. This amendment is to document IRB reliance between UCR and USF.


Eligibility criteria: Inclusion Criteria:

* people living with HIV
* biomedical HIV researchers
* IRB members/bioethicists involved in HIV research

Exclusion Criteria:

* people under 18 years of age
* people living outside of the United States
* people who do not speak English

Primary outcomes:
measure: characterize how people living with HIV assess incentives
timeFrame: 3 months
measure: characterize key stakeholders' views on and assessment of incentives
timeFrame: 3 months
measure: pilot testing vignettes for incentive decision making
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Riverside
country: United States
facility: UC Riverside
state: California
Study officials:
References:
citation: Galea JT, Greene KY, Nguyen B, Polonijo AN, Dube K, Taylor J, Christensen C, Zhang Z, Brown B. Evaluating the Impact of Incentives on Clinical Trial Participation: Protocol for a Mixed Methods, Community-Engaged Study. JMIR Res Protoc. 2021 Nov 23;10(11):e33608. doi: 10.2196/33608.
Clinical trial NCT01571713: Side Effects of Pulmonary Hypertension Medications
Official title: Patient Reported Side Effects of Pulmonary Hypertension (PH) Medications
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Hypertension
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2012-04-05
Enrollment: 250
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patients with pulmonary hypertension seen in the pulmonary hypertension clinic at Stanford Lucile Packard Children's Hospital

Brief summary: The study seeks to analyze the patient reported effects of pulmonary hypertension medications and compare these with the side effects described on the package inserts. Side effects for these PH medications have been described in the adult population, but have never been described in the pediatric population. This information can better improve patient care and be used to characterize the side effects resultant from these medications.

Detailed description: As part of standard of care, patients are routinely asked about any symptoms they might be experiencing. This study seeks to quantify these symptoms for research purposes. Participants will be identified through those who attend the pediatric pulmonary hypertension clinic at LPCH. Only children who are currently on one of seven PH medications (Bosentan, Epoprostenol, Letairis, Sildenafil, Tadalafil, Treprostinil, Ventaris) will be approached. Patients who consent to be in the study will answer a brief series of questions pertaining to the presence and duration of their symptoms. These will be correlated to a list of side effects taken from Lexicomp (a medication database).

Eligibility criteria: Inclusion Criteria:

* pulmonary hypertension
* currently taking at least one of the following PH medications (Bosentan, Epoprostenol, Letairis, Sildenafil, Tadalafil, Treprostinil, Ventaris)

Exclusion Criteria:

* \>18 years

Primary outcomes:
measure: Patients Experience Side Effects
timeFrame: Open
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Lucile Packard Children's Hospital at Stanford
state: California
Study officials:
affiliation: Stanford University
name: Jeffrey Feinstein, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00040313: Pegaptanib Sodium Compared to Sham Injection in Patients With DME Involving the Center of the Macula
Official title: A Phase II Randomized, Controlled, Double-Masked, Dose-Finding, Multi-Center, Comparative Trial, in Parallel Groups, to Establish the Safety and Preliminary Efficacy of Intravitreal Injections of EYE001 (Anti-VEGF Pegylated Aptamer), Given Every 6 Weeks for 12 to 30 Weeks to Patients With Clinically Significant Diabetic Macular Edema (CSME) Involving the Center of the Macula
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Macular Edema
Lead sponsor: Eyetech Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2002-06-25
Enrollment: 0
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: The purpose of the study is to determine whether pegaptanib sodium (Macugen) is safe and effective in slowing the leakage of fluid within the retina and thereby stabilizing or improving vision when compared to placebo injections. A total of 176 patients will be enrolled


Eligibility criteria: Inclusion Criteria:

Patients with clinically significant DME, VA 20/50-20/320 in the study eye and 20/100 in the fellow eye

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00326313: Clinical Outcome of Neonates With GBS Positive Culture-12 Year Retrospective Study
Official title: Clinical Outcome of Neonate With GBS Positive Culture-12 Year Retrospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infants With Positive GBS Bacteremia
Keywords: Group B streptococci
virulent
morbidity
mortality
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2006-05-16
Enrollment: 74
Sex: ALL
Minimum age (years): 0
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no

Brief summary: Streptococci group B (GBS) is a the major reason for morbidity and mortality in neonates. It can present as pneumonia ,meningitis or sepsis.The mortality today is 5-20% and even more in preterm babies.

During the past two decade, the introduction of protocols for prophylactic antibiotics for women with a high risk for GBS infection, have led to a decline of 65% in GBS cases(0.32 for 1000 live birth compared to 1.8 cases in 1000).The purpose of the study is to check the morbidity and mortality at Sheba medical center in the last 12 years in children with positive blood culture for GBS. We assume that in our hospital the morbidity and mortality is less then expected. If proven right, we would then check the reasons for that outcome considering the type and length of treatment and the different virulence of the streptococcus.

Detailed description: This is a retrospective case control study. We will review from archive the charts of all the neonates with positive blood culture for GBS, reviewing the course and severity of their illness.

Eligibility criteria: Inclusion Criteria:

* GBS positive blood culture neonate and preterm babies

Exclusion Criteria:

* Congenital malformations

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Sheba Medical Center
name: Tzipora Strauss, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01384136: The Telomere System in Cord Blood and in the Placenta in High Risk Pregnancies
Official title: The Telomere System in Cord Blood and in the Placenta in High Risk Pregnancies
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Telomere Length
Mechanisms of Telomter Homeostasis
High Risk Pregnancies
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2011-06-28
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: High risk pregnancies, third trimester, after the delivery/

Brief summary: The telomere system stabilizes the chromosomes. Telomeres are shortened during senescence, in cases of genetic instability and secondary to stress.

The investigators aim is to study the telomere system in cord blood and in the placenta immediately after the delivery in pregnancies defined as high risk pregnancies following sterss events such as placental insufficiency, preeclampsia, diabetes.

The investigators intend to compare the telomere system in maternal blood to cord blood and to placental biopsies and to study the influence of different stressogenes on this system.


Eligibility criteria: Inclusion Criteria:

* Third trimester post delivery
* Intrauterine growth restriction
* Preeclampsia
* Diabetes
* Control - low risk normal pregnancies

Exclusion Criteria:

* Patients who do not want to participate
* Known HIV or Hepatitis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medical Center
Study officials:
References:
Clinical trial NCT03007836: High-activity Natural Killer Immunotherapy for Small Metastases of Nasopharyngeal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Metastatic Nasopharyngeal Cancer
Keywords: Metastatic Nasopharyngeal Cancer
High-activity natural killer
Lead sponsor: Fuda Cancer Hospital, Guangzhou
Sponsor class: OTHER
Collaborators: name: Shenzhen Hank Bioengineering Institute
First posted: 2017-01-02
Enrollment: 20
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is the safety and efficacy of high-activity natural killer immunotherapy to small metastases of nasopharyngeal cancer.

Detailed description: By enrolling patients with small metastases of nasopharyngeal cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of high-activity natural killer cells.

The safety will be evaluated by statistics of adverse reactions. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).

Eligibility criteria: Inclusion Criteria:

* All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies after cancer recurrence
* Body tumor 1-6, the maximum tumor length \< 2 cm
* KPS ≥ 70, lifespan \> 6 months
* Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L

Exclusion Criteria:

* Patients with cardiac pacemaker
* Patients with brain metastasis
* Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction

Primary outcomes:
measure: Relief degree of tumors
timeFrame: 3 months
Secondary outcomes:
measure: Progress free survival（PFS）
timeFrame: 1 year
measure: Overall survival（OS）
timeFrame: 3 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Fuda cancer institute of Fuda cancer hospital
state: Guangdong
Study officials:
References:
Clinical trial NCT02724436: Radioembolization With Yittrium-90 for Intermediate and Advanced Hepatocellular Carcinoma
Official title: Radioembolization With Yittrium-90 for Intermediate and Advanced Hepatocellular Carcinoma: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatocellular Carcinoma
Radioembolization
Keywords: Yittrium-90
Hepatocellular Carcinoma
Lead sponsor: Eastern Hepatobiliary Surgery Hospital
Sponsor class: OTHER
First posted: 2016-03-31
Enrollment: 200
Sex: ALL
Minimum age (years): 17
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hepatocellular carcinoma (HCC) is the fifth most-common cancer worldwide and the second most-common cause of cancer mortality. Liver resection is the first-line curative treatment for huge HCC. The 5-year overall survival (OS) rates after hepatic resection were range from 25% to 45%. Transarterial chemoembolization (TACE) is the major treatment option for the unresectable primary or secondary liver malignancies. Yittrium-90 (Y-90) is a pure beta-emitter, without any toxic effect or immune rejection. There are ample data that support the use of Y-90 microspheres for primary and metastatic liver tumors. The aim of our study was to compare the clinical outcome of radioembolization with Y-90 and TACE and provide a new strategy for the treatment of intermediate and advanced hepatocellular carcinoma with portal vein thrombus by conduting a randomized trial.


Eligibility criteria: Inclusion Criteria:

1. Child-Pugh class A or B liver function;
2. Preoperative ECOG criteria score of 0-2;
3. Patients preoperatively diagnosed of hepatocellular carcinoma according to chest computed tomography (CT) and/or magnetic resonance imaging (MRI);
4. Tumor number ≤5 and the sum of largests tumor diameter ≤15 cm;
5. The expected survival time \>6 months.

Exclusion Criteria:

1. Other anticancer treatment before treatment
2. Patients with apparent major organs (i.e. cardiac, pulmonary, cerebral and renal) dysfunction, which may affect the treatment of liver cancer
3. Patients with other diseases that may affect the treatment of this treatment
4. History of other malignant tumors
5. Patients who are participating in other clinical trials
6. Pregnant, lactating women

Primary outcomes:
measure: Overall survival
timeFrame: 3 years
measure: Time to progress
timeFrame: 3 years
measure: Toxic and side effects caused by TACE or radioembolization with Y-90
timeFrame: 3 years
measure: Postoperative complication
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Eastern hepatobilliary surgery hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT00890136: Chronic Obstructive Pulmonary Disease (COPD) and Domestic Endotoxin (CODE)
Official title: COpd and Domestic Endotoxin (CODE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic Obstructive Pulmonary Disease (COPD)
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute of Environmental Health Sciences (NIEHS)
First posted: 2009-04-29
Enrollment: 84
Sex: ALL
Minimum age (years): 40
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Both Male and Female 40 years and older

Brief summary: This project aims to characterize the independent effect of domestic endotoxin exposure on health status, as well as pulmonary and systemic inflammation, in former smokers with COPD. Positive findings from this study would be clinically relevant, as they would provide evidence to support aggressive reduction of ongoing endotoxin exposure in patients with COPD. The investigators also hope to make a methodological advance in the field of endotoxin exposure assessment by elucidating whether settled dust and/or airborne endotoxin measurements are the more relevant exposure of interest in epidemiological studies of respiratory disease. To fulfill the specific aims, the investigators will conduct a longitudinal study, including 75 former smokers with COPD. All subjects will have indoor air monitoring, in-home settled dust collections, home inspections as well as assessments of health status, quality of life (QOL), lung function and pulmonary and systemic inflammation.


Eligibility criteria: Inclusion Criteria:

* Patient reported physician diagnosis of COPD/Chronic Bronchitis/Emphysema
* Cigarette Smoking \> 10 pack-years
* Age \> 40 years
* Has not smoked \> 1 year
* Post BD FEV1/FVC ≤ 70%
* Post BD FEV1 (% predicted) 30-80%
* Ability and willingness to provide consent

Exclusion Criteria:

* Non- English speaking
* Planning to move or live away from the home during the study period
* Co-morbid illnesses such as:

  * Current physician diagnosis of Asthma
  * Other pulmonary diseases
  * Systemic disease requiring treatment with immunosuppressive agents
  * Known alpha-1 antitrypsin deficiency
  * Occupational exposure with high endotoxin exposure
* Within the last 6 months Use of oral corticosteroids

Primary outcomes:
measure: statistical analysis
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Karina Romero
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Nadia Hansel, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01850836: Dual Hemisphere rTMS for Rehabilitation of Post Stroke Aphasia
Official title: Treatment of Aphasic Stroke Patients With rTMS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non Fluent Aphasia in Subacute Stroke
Keywords: Aphasia, Stroke, repetitive transcranial magnetic stimulation.
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2013-05-10
Enrollment: 29
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the therapeutic effect of dual hemisphere repetitive transcranial magnetic stimulation (rTMS) on post-stroke non fluent aphasia.

Detailed description: Thirty patients with subacute post-stroke non-fluent aphasia were randomly allocated with a ratio 2:1 to receive real (n = 20) or sham (n = 10) rTMS of the affected motor cortex. Each patient received 1000 rTMS pulses (1 Hertz at 110% of resting motor threshold) over the unaffected Broca's area and 1000 pulses (20 Hertz at 100% resting motor threshold) over affected left Broca's area for 10 consecutive days. LANGUAGE section of hemispheric stroke scale, Stroke Aphasic Depression Questionnaire Hospital Version (SADQ-H) and NIH stroke scale were assessed before, post sessions, 1 and 2 months after the last session . Motor threshold was assessed before and after the end of last session.

Eligibility criteria: Inclusion Criteria:

* acute hemiplegia with non-fluent aphasia, single thromboembolic non-haemorrhagic infarction documented by computerized tomography (CT) in the distribution of middle cerebral artery.

Exclusion Criteria:

* head injury or neurological disease other than stroke,
* Unstable cardiac dysrhythmia,
* Fever,
* Infection,
* Hyperglycaemia
* Prior administration of tranquilizer
* Patients with no motor evoked response recorded from first dorsal interosseus (FDI) muscle of the affected hand

Primary outcomes:
measure: Hemispheric stroke scale (HSS)
timeFrame: Change from Baseline in HSS at 2 months
Secondary outcomes:
measure: NIH Stroke Scale (NIHSS)
timeFrame: Change from Baseline in NIHSS at 2 months
Other outcomes:
measure: Stroke Aphasic Depression Questionnaire Hospital Version (SADQ-H)
timeFrame: Change from Baseline in SADQ-H at 2 months
Locations:
Study officials:
References:
Clinical trial NCT02174536: A Double Blind Randomized Study Using Placenta Derived Decidual Stromal Cells for Hemorrhagic Cystitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hemorrhagic Cystitis
Stem Cell Transplantation
Decidual Stromal Cells
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2014-06-25
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A prospective double blind randomized study comparing placenta derived decidual stromal cells with placebo for hemorrhagic cystitis after allogeneic hematopoietic cell transplantation. It is hypothesized that the decidual stromal cell therapy will be superior to placebo.

Detailed description: Patients with grade 2-4 hemorrhagic cystitis will be randomized to receive either decidual stromal cell therapy at approximately 1x106 cells/kg or placebo on two occasions at weekly intervals. Patients not responsive within 2 weeks will receive decidual stromal cells at approximately 1x106 cells/kg openly.

Eligibility criteria: Inclusion Criteria:

* Hemorrhagic cystitis grade 2-4
* Receives Misoprostol therapy

Exclusion Criteria:

* Patients with urinary urge without macroscopic hematuria or clots

Primary outcomes:
measure: Days to disappearence of macroscopic hematuria or clots
timeFrame: 1 month after inclusion
Secondary outcomes:
measure: Time to disappearance of pain or urges
timeFrame: 1 month after inclusion
measure: Time to disappearance of microscopic hematuria
timeFrame: 1 month after inclusion
measure: Transplant related mortality
timeFrame: 1 year after inclusion
measure: Incidence of severe infections
timeFrame: 1 year after inclusion
measure: Incidence of graft versus host disease
timeFrame: One year after inclusion
measure: Overall actuarial survival
timeFrame: Actuarial
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
affiliation: Karolinska Institutet
name: Olle Ringdén, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: