louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00858000: Analysis of Expression of Specific Markers in Hepatocellular Carcinoma
Official title: Analysis of the Incidence of Expression of a Specific Set of Genes and of Tumor Antigens in Cancer Tissue From Patients With Hepatocellular Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma
Keywords: markers
expression analysis
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2009-03-09
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic

Brief summary: Hepatocellular carcinoma is an aggressive disease with limited therapeutic options. Therefore, new approaches to treat this type of cancer are needed with immunotherapy potentially being one of these. As a first step in the development of novel therapies, expression analysis of specific markers, including tumor antigens will be carried out. This will be done retrospectively using available hepatocellular carcinoma tissue samples.


Eligibility criteria: Inclusion Criteria:

* The patient had pathologically proven hepatocellular carcinoma
* All the data required are available from patient's records
* A sufficient amount of RNA is available for all three tissue samples

Exclusion Criteria:

N/A

Primary outcomes:
measure: This study will also analyze whether this gene-expression signature is present in matched cirrhotic tissue and the interface tissue with the tumor.
timeFrame: At the time of analysis.
measure: Proportion of hepatocellular carcinoma cancer patients whose tumor tissue -expresses any one or more of specific target antigens -overexpresses c-MET -expresses a pre-defied gene-expression signature
timeFrame: At the time of analysis.
Secondary outcomes:
Other outcomes:
Locations:
city: Firenze
country: Italy
facility: GSK Investigational Site
state: Toscana
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00002400: A Study of Two Anti-HIV Drug Combinations in HIV-Infected Patients
Official title: An Open-Label Randomized Study of Delavirdine Mesylate (Rescriptor) in Combination With Zidovudine (Retrovir) and Two Doses of Indinavir (Crixivan) Versus Zidovudine, Lamivudine (Epivir), and Indinavir in HIV-1-Infected Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: HIV-1
Drug Therapy, Combination
Zidovudine
HIV Protease Inhibitors
Lamivudine
Indinavir
RNA, Viral
Delavirdine
Reverse Transcriptase Inhibitors
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the safety and effectiveness of giving HIV-infected patients delavirdine (DLV) plus zidovudine (ZDV) plus 2 doses of indinavir (IDV) or ZDV plus IDV plus lamivudine (3TC). This study also examines how the body processes DLV when it is given in combination with other drugs.

Detailed description: In this multicenter, open-label study, 45 HIV-1-positive patients receive either combination drug therapy with delavirdine (DLV), zidovudine (ZDV), and indinavir (IDV) or combination drug therapy with ZDV, lamivudine (3TC), and IDV. NOTE: Patients are treated for 24 weeks and may opt to continue on study for 24 additional weeks, if HIV-1 RNA is less than 5,000 copies/ml or at the investigator's discretion.

Eligibility criteria: Inclusion Criteria

Patients must have:

* HIV-1 positive.
* CD4 count above 50.
* HIV-1 RNA greater than 20,000.

Prior Medication:

Allowed:

Less than 1 month prior treatment with zidovudine.

Exclusion Criteria

Prior Medication:

Excluded:

* Prior 3TC, protease inhibitors, or non-nucleoside reverse transcriptase inhibitors.
* Prior ZDV of greater than 1 month total duration.

Prior Treatment:

Excluded:

* Lamivudine.
* Protease inhibitors.
* Non-nucleoside reverse transcriptase inhibitors.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Peapack
country: United States
facility: Pharmacia & Upjohn
state: New Jersey
Study officials:
References:
Clinical trial NCT06947200: Orthorexia Nervosa in Fibromyalgia
Official title: Is There a Link Between Orthorexia Nervosa, Body Image and Psychological State in Women With Fibromyalgia Syndrome?
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Fibromyalgia
Lead sponsor: Beylikduzu State Hospital
Sponsor class: OTHER
First posted: 2025-04-27
Enrollment: 84
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with fibromyalgia syndrome

Brief summary: This clinical cross-sectional study will include 84 female patients aged between 18 and 65 years who have been diagnosed with fibromyalgia syndrome according to the 2010 American College of Rheumatology diagnostic criteria. Sociodemographic data will be recorded at the beginning of the study. Pain severity will be assessed using the Visual Analog Scale (VAS). Orthorexia nervosa-related symptoms will be evaluated with the ORTO-11 scale. Body image will be assessed with the Body Appreciation Scale 2, mood will be evaluated using the Hospital Anxiety and Depression Scale (HADS), and fibromyalgia-related impact will be assessed with the Fibromyalgia Impact Questionnaire (FIQ).


Eligibility criteria: Inclusion Criteria:

* Female patients aged 18-65 years.
* Diagnosis of fibromyalgia syndrome according to the 2010 American College of Rheumatology diagnostic criteria.
* Willingness to participate and provision of written informed consent.

Exclusion Criteria:

* Refusal to participate.
* Presence of diagnosed psychiatric disorders.
* Presence of cognitive impairment.
* Use of medications that may affect mood.

Primary outcomes:
measure: ORTO-11 Scale
timeFrame: Baseline
Secondary outcomes:
measure: Hospital Anxiety Scale (HADS-A):
timeFrame: Baseline
measure: Hospital Depression Scale (HADS-D):
timeFrame: Baseline
measure: Body Appreciation Scale-2 (BAS-2)
timeFrame: Baseline
measure: Fibromyalgia Impact Questionnaire (FIQ)
timeFrame: Baseline
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Beylikdüzü State Hospital
Study officials:
References:
Clinical trial NCT03615300: Predicting Long-term Outcomes After Cardiac Arrest by Using Serum NGAL
Official title: Predicting Long-term Outcomes After Cardiac Arrest by Using Serum NGAL: A Prospective, Observational Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Out-of-Hospital Cardiac Arrest
Lead sponsor: Uijeongbu St. Mary Hospital
Sponsor class: OTHER
First posted: 2018-08-03
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult survivors after out-of-hopital cardiac arrest who underwent targeted temperature management and survived longer than 3 days.

Brief summary: This study was performed to determine the prognosis of patients after cardiac arrest using serum markers called NGAL. The initial NGAL values of patients with post-cardiac arrest syndrome are checked by blood tests, and the long-term neurological prognosis and survival rate are collected after 6 months.

Detailed description: Serum NGAL is currently being used as a test to determine the likelihood of developing renal failure. However, in a previous study, serum NGAL correlated with neurological prognosis in post cardiac arrest syndrome patients. This prospective study attempts to see the role of serum NGAL as a prognostic factor by including a sufficient number of patients.

Eligibility criteria: Inclusion Criteria:

* Adult patients who underwent targeted temperature management after out-of-hospital cardiac arrest.

Exclusion Criteria:

* Patients who did not survived 3 days after cardiac arrest.
* Pre-existing end-stage renal disease or dependence on renal replacement therapy

Primary outcomes:
measure: Long term neurologic outcome
timeFrame: 6 months
Secondary outcomes:
measure: Proportion of participants with Overall Survival at 6 months
timeFrame: 6 months
Other outcomes:
Locations:
city: Uijeongbu-si
country: Korea, Republic of
facility: Uijeongbu St. Mary's Hospital
state: Gyeonggi-do
Study officials:
affiliation: The Catholic University of Korea, Uijeongbu ST. Mary's Hospital
name: Joo Suk Oh, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Elmer J, Jeong K, Abebe KZ, Guyette FX, Murugan R, Callaway CW, Rittenberger JC; Pittsburgh Post-Cardiac Arrest Service. Serum Neutrophil Gelatinase-Associated Lipocalin Predicts Survival After Resuscitation From Cardiac Arrest. Crit Care Med. 2016 Jan;44(1):111-9. doi: 10.1097/CCM.0000000000001357.
citation: Park YR, Oh JS, Jeong H, Park J, Oh YM, Choi S, Choi KH. Predicting long-term outcomes after cardiac arrest by using serum neutrophil gelatinase-associated lipocalin. Am J Emerg Med. 2018 Apr;36(4):660-664. doi: 10.1016/j.ajem.2017.12.013. Epub 2017 Dec 7.
Clinical trial NCT05418400: Clinical Evaluation of Different Resin Composite Restorations
Official title: Comparative Study of Clinical Criteria of Different Resin Composite Restorations Among Lower Molars
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Caries
Keywords: composite resin
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2022-06-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Posterior resin composite is challenging esthetic restoration. Patients seek for durable, esthetic and functional restorations in molars. one of the major problems is polymerization shrinkage. Some materials were developed to overcome the polymerization shrinkage, among them bulk fill resin composite which have been developed to reduce the shrinkage stress during polymerization and offer much greater depth of cure. This is achieved by the addition of fillers such as barium aluminum silicate filler, ytterbium trifluoride and mixed oxides. Furthermore, a prepolymerized fillers have been added with silanes to reduce shrinkage stress. so, the objective of this trial is to clinical Evaluate and compare clinical performance of bulk fill VS incremental filling technique.


Eligibility criteria: Inclusion Criteria:

inclusion criteria of participants:

* Male gender
* Good oral hygiene
* Only Cooperative patient
* Medically free patient
* Age range 18-24

inclusion criteria of the teeth:

* Vital teeth with no periapical lesion or radiolucency.
* Prepared cavity with no undermined enamel walls.
* Functioning tooth with presence of an opposing.
* Healthy periodontium.

Exclusion Criteria:

* exclusion criteria of participants:

  * Old age patients
  * Patients have systemic disease or sever medically compromised
  * Patients with bruxism, clenching or temporomandibular joint disorder.
  * Por oral hygiene

exclusion criteria of teeth:

* Teeth with periapical lesions.
* Teeth with visible cracks.
* Teeth with mobility.
* Non-functioning tooth with no opposing tooth.
* Heavy occlusion or signs of sever attrition.
* Tooth with Periodontal affection.

Primary outcomes:
measure: Post operative sensitivity
timeFrame: along one year
measure: marginal discoloration
timeFrame: along one year
measure: marginal adaptation
timeFrame: along one year
measure: recurrent caries
timeFrame: along one year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of dental medicine Al Azhar university
Study officials:
affiliation: Faculty of dental medicine Al Azhar university
name: Nady Ebrahem Hasanin, professor
role: STUDY_CHAIR
References:
Clinical trial NCT01444300: Dalfampridine for Imbalance in Multiple Sclerosis
Official title: Dalfampridine to Improve Imbalance in Multiple Sclerosis: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Sclerosis
Fatigue
Keywords: multiple sclerosis
postural balance
gait
fatigue
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Acorda Therapeutics
First posted: 2011-09-30
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Dalfampridine is a new medication that was FDA approved in 2010 to improve walking speed in people with Multiple Sclerosis (MS). People with MS walk slowly in part because MS damages the myelin insulation around nerves which slows conduction of messages from the brain to the leg muscles. Dalfampridine works by improving conduction in nerves with damaged myelin. Recent research indicates that imbalance in MS is in large part caused by poor conduction by the nerves that transmit information about the position of the legs to the brain. It is therefore likely that, by improving nerve conduction, dalfampridine will also improve imbalance in people with MS. Dalfampridine will be administered in this study by the same route (oral), dosage (10mg), and frequency (every 12 hours) approved by the FDA to improve walking speed in people with MS. The proposed pilot study will examine the effects of dalfampridine on imbalance in 24 subjects with Multiple Sclerosis (MS) and imbalance. This small pilot study will help to show if dalfampridine improves imbalance in MS and will guide the design and implementation of a larger full scale study to definitively determine if dalfampridine improves balance and prevents falls in people with MS.


Eligibility criteria: Inclusion Criteria:

* Age 20- 59 years,
* Able to walk at least 100m without an aide or with unilateral assistance
* Prolonged APR latencies (≥ 1SD \> mean for healthy people in this age range) OR,
* Reduced balance-related activity (ABC scores ≤ 85%),
* Abnormal trunk range of motion (horizontal), trunk range of motion (frontal), turning duration, cadence, double support time, stride length or gait cycle time (outside 1SD of the average for healthy people in this age range)

Exclusion Criteria:

* Currently taking dalfampridine (any within the last 2 weeks),
* Cause(s) of imbalance other than MS,
* Impaired renal function (creatinine clearance ≤50mL/min),
* Seizure disorder
* Pregnancy or breast feeding

Primary outcomes:
measure: Change in Automatic Postural Response (APR )Latency
timeFrame: Baseline to 12 weeks
Secondary outcomes:
measure: Change in Activities-specific Balance Confidence (ABC) Questionnaire Scores
timeFrame: Baseline to 12 weeks
measure: Change in Timed 25 Foot Walking Speed
timeFrame: Baseline to 12 weeks
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
References:
Clinical trial NCT00453700: Prevalence of Chagas Disease in Immigrant Patients With Conduction Abnormalities on Electrocardiogram
Official title: Prevalence of Chagas Disease in Immigrant Patients With Conduction Abnormalities on Electrocardiogram
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chagas Disease
Keywords: chagas
trypanosoma cruzi
Lead sponsor: Olive View-UCLA Education & Research Institute
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2007-03-29
Enrollment: 327
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All Latin American immigrant patients with newly diagnosed nonischemic cardiomyopathy at one U.S. medical center were asked to participate in this study.

Brief summary: Chagas disease is endemic to the Americas, infecting between 16-18 million individuals. In immigrant populations in the United States from endemic areas, it is estimated up to 4.9% may be asymptomatic carriers of Trypanosoma cruzi, the organism which causes Chagas disease. Between 10-20% of these patients progress to development of end-stage cardiomyopathy with a high associated morbidity. Following acute disease, patients enter into an indeterminate phase which can last 10-20 years. The earliest sign of cardiac involvement usually is electrocardiogram abnormalities. The most common abnormality is right bundle branch block (RBBB), followed by left anterior fascicular block (LAFB), and left bundle branch block (LBBB). Recent studies have shown that treatment of patients at this stage with antiparasitics may delay the progression of overt cardiomyopathy.

At the University of California, Los Angeles, there is a large population of immigrant patients from countries endemic to Chagas disease. The researchers propose that screening patients with conduction abnormalities on electrocardiogram may be a potentially useful method to identify patients with early cardiac manifestations of Chagas disease. The researchers hope to enroll approximately 300 individuals with RBBB, LAFB or LBBB on electrocardiogram to determine the incidence of Chagas disease in this patient population.


Eligibility criteria: Inclusion Criteria:

* One of the following EKG abnormalities:

  * Complete or incomplete right bundle branch block (RBBB)
  * Left anterior fascicular block (LAFB)
  * Left bundle branch block (LBBB)
* Residence at any point in past in an endemic area (any country in Central or South America or Mexico) for at least 12 months.
* Age \>18 and \<60.

Exclusion Criteria:

* Ejection fraction \<40%
* Symptomatic heart failure
* Documented coronary artery disease

Primary outcomes:
measure: Prevalence of positive trypanosoma cruzi serologies
timeFrame: At enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Sylmar
country: United States
facility: OV-UCLA Medical Center
state: California
Study officials:
affiliation: OV-UCLA Medical Center
name: Sheba K Meymandi, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02935400: Acute Porphyria Biomarkers for Disease Activity
Official title: Acute Porphyrias: Biomarkers for Disease Activity and Response to Treatment
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Acute Intermittent Porphyria
Hereditary Coproporphyria
Variegate Porphyria
Keywords: porphyria
biomarkers
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
First posted: 2016-10-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acute intermittent porphyria, hereditary coproporphyria, variegate porphyria.

Brief summary: The long term objective of the research is to identify new biomarkers of disease activity in the human acute porphyrias. This pilot study is intended to provide pilot and feasibility data needed to plan larger and more definitive future studies.

Detailed description: This translational pilot research is based on preliminary results using animal models. The investigators will collect samples of blood, urine and feces from up to 50 participants with well documented acute porphyrias, at 2 expert sites that are members of the Porphyrias Consortium. Collection and analysis of these samples will be used to assess feasibility of performing such studies in humans with acute porphyrias, recognizing that these disorders are more heterogeneous than reproduced in animal models, and affect individuals who cannot all be studied simultaneously and in large groups. Therefore, we will assess the feasibility of methods for collecting, processing, storing and shipping samples at multiple study sites for later biomarker analysis. Larger and more definitive studies of biomarkers will be designed and implemented based on data and experience from this pilot-feasibility study.

Eligibility criteria: Inclusion Criteria:

* Documented diagnosis of acute porphyria.

  1. For AIP: Elevation in urine PBG, with normal or only slight increases in plasma and fecal porphyrins. Most (\~90%) will have deficient activity of erythrocyte PBGD.
  2. For HCP: Elevation in urine PBG, with substantial increases in fecal porphyrins (almost entirely coproporphyrin III). In the absence of skin photosensitivity, most will have normal or only slight increases in plasma porphyrins.
  3. For VP: Elevation in PBG, with substantial increases in fecal porphyrins (mostly coproporphyrin III and protoporphyrin), increased plasma total porphyrins and a fluorescence emission maximum of diluted plasma at neutral pH near 626 nm.

Exclusion Criteria:

* Another medical condition that might confound the results, as judged by the investigator

Primary outcomes:
measure: Potential biomarkers Biomarkers
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
Study officials:
affiliation: University of Texas
name: Karl E Anderson
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01289600: Mechanical Ventilation and Respiratory Muscle Work of Breathing in Acute Respiratory Distress Syndrome (ARDS) Patients
Official title: The Role of Diaphragm Electromyography (EMG) Guided Mechanical Ventilation on Respiratory Physiology in Mechanically Ventilated Patients With Acute Respiratory Distress Syndrome (ARDS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ARDS
Lead sponsor: University Medical Center Nijmegen
Sponsor class: OTHER
First posted: 2011-02-04
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to demonstrate that mechanical ventilation guided by the diaphragm EMG signal (also know as neurally adjusted ventilatory assist \[NAVA\]) is superior compared to pressure support and pressure control ventilation.


Eligibility criteria: Inclusion Criteria:

* intubated, mechanically ventilated patients
* meeting criteria for ARDS
* mean arterial blood pressure \> 65 mmHg (with or w/o vasopressors)

Exclusion Criteria:

* pregnancy
* increased intracranial pressure
* contra-indication naso-gastric tube
* diagnosed neuro-muscular disorder
* recent (\<12 hours) use of muscle relaxants
* exclusion from sedation interruption protocol as used in our institution
* open chest or- abdomen
* very high inspiratory flow rate during supported ventilation
* inability to obtain informed consent

Primary outcomes:
measure: Pressure-time product of the diaphragm
timeFrame: average of last 15 minutes of each study arm
measure: Patient - ventilator asynchrony index
timeFrame: average of last 15 minutes of each study arm
Secondary outcomes:
measure: Transpulmonary pressure
timeFrame: average of last 15 minutes of each study arm
measure: Transdiaphragmatic pressure
timeFrame: average of last 15 minutes of each study arm
measure: Oxygenation index
timeFrame: at the end of each study arm
measure: Dead space ventilation
timeFrame: average of last 15 minutes of each study arm
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: University Medical Center Nijmegen
state: Gelderland
Study officials:
affiliation: Radboud University Nijmegen Medical Center
name: Leo Heunks, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: