louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01534195: Evaluation of the Efficacy of Topical Ophthalmic Steroids in a Modified Conjunctival Allergen Challenge (CAC) Model
Official title: A Phase 4, Randomized, Double-Masked, Single Center, Placebo-Controlled Adaptive Clinical Trial, Using Prednisolone Sodium Phosphate Ophthalmic Solution, 1%, in Subjects With Allergic Conjunctivitis to Evaluate a Modified Conjunctival Allergen Challenge (CAC) Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Allergic Conjunctivitis
Lead sponsor: ORA, Inc.
Sponsor class: INDUSTRY
First posted: 2012-02-16
Enrollment: 11
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: The purpose of this study is to evaluate the effectiveness of the modified Conjunctival Allergen Challenge (CAC) and observe how the produced allergic inflammation reacts to treatment with a proven ocular anti-inflammatory medication,

Prednisolone, assessed by the following measures:

* Ocular itching
* Conjunctival redness

Detailed description: Prospective, single center, randomized, double-masked, placebo controlled study. Subjects will be randomized to one of the following treatment arms to dose four times per day (QID) for 8 days between Visits 4 and 5.

* Prednisolone phosphate
* Tears Naturale II Ophthalmic Solution (Placebo)

Duration:

Approximately 19 days

Controls:

Artificial Tears (Tears Naturale® II)

Eligibility criteria: Inclusion Criteria:

* At least 18 years of age \& either sex, any race
* Willing and able to follow all instructions
* Positive history of ocular allergies
* Reproducible positive ocular allergic reaction induced by conjunctival allergen challenge

Exclusion Criteria:

* Have planned surgery during trial period
* Female currently pregnant, planning a pregnancy or lactating
* Use of disallowed medications
* Have ocular infections, or ocular conditions that could affect study parameters
* Have moderate to severe dry eye
* Have used an investigational drug or device within 30 days of start of study
* Female that is currently pregnant, planning a pregnancy or lactating

Primary outcomes:
measure: Ocular Itching Change From Baseline to Day 11
timeFrame: 5 minutes post-CAC
Secondary outcomes:
measure: Conjunctival Redness Change From Baseline to Day 11
timeFrame: 7 Minutes post-CAC
measure: Episcleral Redness Change From Baseline to Day 6
timeFrame: 7 minutes post-CAC
measure: Ciliary Redness Change From Baseline to Day 6
timeFrame: 7 minutes post-CAC
Other outcomes:
Locations:
city: Andover
country: United States
facility: Andover Eye Associates
state: Massachusetts
Study officials:
affiliation: Ophthalmic society of Egypt, Egyptian Glaucoma Society, American Acadamy of Ophthalmology, American Glaucoma Society, The association for research in vision and ophthalmology, international society of refractive surgery, Pan Arab Glaucoma Society
name: Tarek Shazly, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06266195: Spectroscopic Profiling of Extracellular Vesicles By Resonant Gold Nanostructures in the Infrared
Official title: Spectroscopic Profiling of Extracellular Vesicles By Resonant Gold Nanostructures in the Infrared
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Vesicle
Keywords: MICROVESCICLES; CIRRHOSIS; HCC; NANOSTRUCTURES.
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 64
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: The target population of this study is divided into two groups: a) control group, 32 cirrhotic patients and b) oncology group, 32 patients diagnosed with hepatocellular carcinoma

Brief summary: Extracellular vesicles, due to their ease of extraction and ability to represent the cells from which they originate, have high potential in the field of personalized medicine, especially in the identification of new early bio-markers of cancer, including hepatocellular carcinoma. Nevertheless, the development of high-throughput diagnostic methods in this area is still in its infancy, and the design of new integrated technological solutions is of great interest and topicality. The main hypothesis of this study is that the development of a novel technology integrating resonant gold nanostructures in the mid-infrared can significantly contribute to the development of new approaches for the diagnosis of hepatocellular carcinoma.


Eligibility criteria: Inclusion

* 18 years old with a diagnosis of liver cirrhosis of different etiology
* 18 years old with a diagnosis of hepatocellular carcinoma

Exclusion

* Have not signed the informed consent
* Pregnant women

Primary outcomes:
measure: primary endpoint
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: FPGemelliIRCCS
state: Lazio
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: FABRIZIO PIZZOLANTE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06128395: ASA 81 mg vs 162 mg During Frozen Embryo Transfer (FET)
Official title: Retrospective Study to Assess if Aspirin 162 mg is Better Than 81 mg for Embryo Transfer Outcomes
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Fertility Disorders
Lead sponsor: Clinique Ovo
Sponsor class: INDUSTRY
First posted: 2023-11-13
Enrollment: 500
Sex: FEMALE
Maximum age (years): 40
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: FET Data spreadsheet from January 2022 to December 2022

Brief summary: The use of low dose aspirin is recommended for high risk patients to reduce the risk of pre-eclampsia, placental abruption and antepartum hemorrhage. Recent studies have shown that in a specific population, the use of low dose aspirin might reduce the risk of preterm birth in pregnant women with singleton pregnancy. In June 2022, clinique ovo started implementing the use of Aspirin 162 mg instead of 81 mg in the frozen embryo transfer cycles based on recent study outcomes. The use of Aspirin 162 mg might have additional benefits on the embryo transfer outcomes by decreasing the miscarriage. Moreover this can be continued until late in pregnancy without adverse effects.


Eligibility criteria: Inclusion Criteria:

* Women taking aspirin 81 mg or 162 mg prior to an autologous embryo transfer
* Age \< 40 years old
* Embryo transfer cycle done at clinique ovo

Exclusion Criteria:

* Egg or embryo recipient
* History of recurrent miscarriages, defined as ≥ 3 consecutive losses
* Patients that needed Viagra, PRP or other modalities to improve their endometrial thickness
* Uterine factor infertility
* Abnormal hormonal profiles
* Stimulated embryo transfer cycles
* History of recurrent implantation failure defined as failed ≥ 2 euploid embryos transfer or ≥ 3 blastocysts

Primary outcomes:
measure: Compare clinical pregnancy rate between patients prescribed Aspirin 81 mg vs Aspirin 162 mg
timeFrame: Time Frame: 6 to 8 weeks after Frozen Embryo Transfer
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Clinique Ovo
state: Quebec
Study officials:
affiliation: Clinique Ovo
name: Wael Jamal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02593695: Deep Brain Stimulation of Nucleus Accumbens to Treat Severe Anorexia Nervosa
Official title: Deep Brain Stimulation of Nucleus Accumbens as a New Treatment to Treat Severe Anorexia Nervosa
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anorexia Nervosa
Keywords: Anorexia Nervosa
Deep Brain Stimulation
Nucleus accumbens
Lead sponsor: Tang-Du Hospital
Sponsor class: OTHER
First posted: 2015-11-01
Enrollment: 10
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: Anorexia nervosa (AN) is a complex and severe psychiatric disorder with high relapse rates under standard treatment.Deep brain stimulation (DBS) may be a novel treatment in severe Anorexia nervosa.


Eligibility criteria: Inclusion Criteria:

1. Age between 18 and 65 years of age, male or female patients.
2. Diagnosis is Anorexia Nervosa(AN) by the DSMIV(Diagnostic and Statistical Manual of Mental Disorders Fourth Edition).
3. BMI\<16.
4. Long-term pharmacotherapy resistance.
5. Written informed consent.
6. normal intelligence and compliance

Exclusion Criteria:

1. Surgical contradiction（implanted artificial cochlea、cardiac pacemaker、cardiac defibrillator、stereotactic ablative surgery、DBS）or receive other surgery which may influence this time of surgery in half year, or other neurosurgical contradictions； History of brain trauma；
2. History of severe neuropsychiatric disease；
3. Epilepsy；
4. severe liver、kidney、heart and lung disease, severe hypertension and severe orthostatic hypotension；
5. Severe diabetes ,severe cardiovascular and cerebrovascular disease；
6. Malignant tumor；
7. Being using anticoagulant or showing clinical hemorrhagic tendency； Pregnant female；
8. Patients are taking part in other clinical trials in recent 3months； Being deem as unfit for the trials by researcher

Primary outcomes:
measure: BMI
timeFrame: 6 month
Secondary outcomes:
measure: weight
timeFrame: 6 month
measure: Yale-Brown Obsessive Compulsive Scale
timeFrame: 6 month
measure: Self-Rating Depression Scale
timeFrame: 6 month
measure: The Symptom Checklist-90
timeFrame: 6 month
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Department of neurosurgery, Tangdu Hospital
state: Shaanxi
Study officials:
affiliation: Department of neurosurgery, Tangdu Hospital
name: Guo-dong Gao, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03668795: Surgical Management of Placenta Accreta
Official title: Surgical Management of Placenta Accreta a Three Year Experience at King Hussein Medical Center
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: To Publish Our Experience in the Surgical Management to Placenta Accreta Cases and the Maternal Outcome
Lead sponsor: Royal Medical Services, Jordanian Armed Forces
Sponsor class: OTHER
First posted: 2018-09-13
Enrollment: 40
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All pregnant ladies who were diagnosed to have placenta previa accreta cases which was diagnosed using ultrasound or MRI

Brief summary: purpose of this study was to report our experience for surgical management of suspected placenta accreta cases encountered in King Hussein medical center

Detailed description: was a retrospective study of all patients who underwent planned deliveries for placenta accreta at King Hussein Medical Centre (KHMC) from August 2011 to October 2014.Demographic characteristics were recorded. Ultrasound (U/S) and magnetic resonance imaging (MRI) were used for the diagnosis. Surgery for all patients were performed by multidisciplinary teams. All information were obtained from patient's files.

Eligibility criteria: Inclusion Criteria:

* all placenta previa accreta cases encountered in our institution over three year period

Exclusion Criteria:

-

Primary outcomes:
measure: The intraoperative and short term postoperative complications of surgical interventions in placenta accreta
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01189695: Maintenance Boosted Lopinavir Monotherapy Following Salvage Protease-inhibitor (PI) Based Regimen in HIV With Non-nucleoside Reverse Transcriptase Inhibitors (NNRTI) Based Regimen Failure
Official title: A Randomized Controlled Study Compares the 48 Weeks Results of HIV-1 RNA Between Ritonavir-boosted Lopinavir Monotherapy and Ritonavir-boosted Lopinavir + Optimized Background Regimens in HIV-1 Infected Patients Who Have HIV-1 RNA <50 Copies/ml More Than 6 Months While Receiving Salvage PI-based Regimen and Previously Failed NNRTI-based Regimen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV
AIDS
Lopinavir
Treatment Failure
Keywords: HIV or AIDS
Lopinavir
Ritonavir
Anti-Retroviral Agents
treatment failure
treatment experienced
NNRTI failure
monotherapy
Lead sponsor: Bamrasnaradura Infectious Diseases Institute
Sponsor class: OTHER_GOV
Collaborators: name: Department of Disease Control, Thailand
First posted: 2010-08-27
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to determine efficacy of ritonavir-boosted lopinavir monotherapy as a maintenance regimen in HIV-1-infected patients who previously failed Non-nucleoside reverse transcriptase inhibitors (NNRTI) based regimens and currently received salvage protease-inhibitor (PI) based regimens.


Eligibility criteria: Inclusion Criteria:

* age 18-60 years
* documented HIV infection
* previously failed to NNRTI-based regimens
* no history of failing PI-based regimens
* receiving ritonavir-boosted PI + OBRs(such as NRITs, etravirine, raltegravir)
* having HIV-1 RNA \<50 copies/ml for at least prior 6 months

Exclusion Criteria:

* Pregnant or breastfeeding woman
* HBV co-infection that had to treated with TDF, FTC or 3TC
* had to received medications known to have potential significant drug interaction with LPV/r
* life expectancy less than 6 months
* serious systemic diseases such as liver cirrhosis Child-Pugh B/C, ESRD, malignancy
* hemoglobin \<8 g/dl, platelet \<50,000/mm3, AST or ALT \>3 ULN, estimated creatinine clearance \<50 mL/min

Primary outcomes:
measure: Time to virological failure
timeFrame: 48 weeks
Secondary outcomes:
measure: Proportion of patients with virological suppression
timeFrame: 48 weeks
measure: Proportion of patients with virological failure
timeFrame: 48 week
measure: Time to loss of virological response (TLOVR)
timeFrame: 48 weeks
measure: Change of CD4 cells count
timeFrame: 48 weeks
measure: Adverse events
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Nonthaburi
country: Thailand
facility: Bamrasnaradura Infectious Diseases Institute
Study officials:
affiliation: Bamrasnaradura Infectious Diseases Institute
name: Krittaecho Siripassorn, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01881295: Bioavailability of Potassium From Potatoes and Potassium Gluconate
Official title: Bioavailability of Potassium From Potatoes and Potassium Gluconate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Potassium Bioavailability
Blood Pressure
Keywords: Potassium
Potato
French Fries
Bioavailability
Blood Pressure
Lead sponsor: Purdue University
Sponsor class: OTHER
Collaborators: name: Alliance for Potato Research and Education
First posted: 2013-06-19
Enrollment: 45
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This study is designed to compare the effect of sources of potassium on uptake and the effect of potassium on blood pressure.

Detailed description: The study will compare uptake of potassium from three different doses and sources; supplements (720, 1440 and 2160 mg) potatoes (720, 1440 and 2160 mg) or French fries (2160 mg).

During 9 phases, participants will consume a controlled diet with the supplements, potato or french fries (every other week for 5 days). On the 4th day, blood and urine samples will be taken to monitor potassium uptake and excretion. Measures of blood pressure will be analyzed at defined time points throughout the intervention.

Eligibility criteria: Inclusion Criteria:

* Able to adhere to the visit schedule, protocol requirements and available to complete the study
* Normotensive men and women
* Aged 20-60 years
* BMI of 15-35

Exclusion Criteria:

* Medication to treat hypertension or hypotension
* Medication known to affect electrolyte metabolism or contain high levels of potassium or sodium
* smoke cigarettes or use illegal drugs
* Hypertension or hypotension
* Diseases known to affect potassium metabolism
* Pregnant
* Allergic to nuts

Primary outcomes:
measure: Bioavailability of Potassium
timeFrame: 5 days
Secondary outcomes:
measure: Blood Pressure Response to Potassium
timeFrame: 6 days
Other outcomes:
Locations:
city: West Lafayette
country: United States
facility: Purdue University
state: Indiana
Study officials:
affiliation: Purdue University
name: Connie M Weaver, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Purdue University
name: Berdine R Martin, Ph.D.
role: STUDY_DIRECTOR
References:
citation: Macdonald-Clarke CJ, Martin BR, McCabe LD, McCabe GP, Lachcik PJ, Wastney M, Weaver CM. Bioavailability of potassium from potatoes and potassium gluconate: a randomized dose response trial. Am J Clin Nutr. 2016 Aug;104(2):346-53. doi: 10.3945/ajcn.115.127225. Epub 2016 Jul 13.
Clinical trial NCT00763295: Is Tuberculin Skin Testing Effective in Screening for Latent Tuberculosis in Patients With HIV?
Official title: Is Tuberculin Skin Testing Effective in Screening for Latent Tuberculosis in Patients With HIV?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Latent Tuberculosis
HIV Infections
Keywords: latent tuberculosis
HIV
IFN-γ based assay
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2008-09-30
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with HIV confirmed by standard methods

Brief summary: HIV infection highly increases the risk of progression of latent tuberculosis (TB) to active disease that therapy is recommended for all PPD-positive, HIV-infected patients, regardless of age. Sensitivity of the PPD testing is, however, dependent on a normal T cell function.

Therefore, an accurate and reliable method for detection of latent tuberculosis in patients with HIV is urgently needed.

This prospective study will examine the utility of interferon-gamma (IFN-γ) based assay, T-SPOT.TB,for detection of TB in HIV-infected individuals.


Eligibility criteria: Inclusion Criteria

* adult individuals with confirmed HIV infection

Exclusion Criteria:

* Patients who are on INH treatment
* Patients who have a positive PPD test within 1 year of study enrollment
* Individuals with blistering or ulcerating skin disorder
* Pregnant women
* Patients who were given blood transfusion within 6 weeks prior to enrollment

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Staten Island
country: United States
facility: Staten Island University Hospital
state: New York
Study officials:
References:
Clinical trial NCT01890395: Bioenergetics in Surgical Patients
Official title: Bioenergetics in Surgical Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mitochondrial DAMP Levels in Surgical Patients
Keywords: mitochondrial DAMPS
Lead sponsor: University of South Alabama
Sponsor class: OTHER
First posted: 2013-07-01
Enrollment: 80
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: To identify patients who may be predisposed for developing MOF (multiple organ failure)by the sampling of blood.

Detailed description: The rationale for doing this study is the recognition that mitochondrial DNA Damage Associated Molecular Patterns (mtDAMPs) accumulate in the circulation after severe injury. Furthermore our own studies in severely injured patients identify that the mtDAMPS are increased 3-28 fold in those patients who eventually develop multiple organ dysfunction syndrome (MODS) compared to those severely traumatized patients who did not develop MODS. The relative risk of death from MODS after severe trauma was increased 8-20 times in those patients with elevated mt DAMP levels.

This study is then being done to correlate mitochondrial damp levels in surgical trauma to assess the time course and the levels of mtDAMPs with the type of surgical procedure. We believe that this information will help us to determine the time course of events and the triggers for development of multiple organ dysfunction seen after surgery.

Eligibility criteria: Inclusion Criteria:

* Patients @ USAMC undergoing surgical operations expected to have microcirculatory changes, i.e., CABG, open heart, aortic or other revascularizing operations, general surgical operations such as colon resections, bowel resections or any other surgical procedures in which the subject could be expected to or might develop multiple system organ failure.

Exclusion Criteria:

N/A

Primary outcomes:
measure: correlation mitochondrial damps (mDAMPS) and multiple organ system failure
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Mobile
country: United States
facility: University of South Alabama Medical Center
state: Alabama
Study officials:
affiliation: University of South Alabama, Department of Surgery
name: William O. Richards, MD
role: PRINCIPAL_INVESTIGATOR
References: