louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01098643: Satisfaction With Placement of Implantable Venous Access Devices in Patients With Solid Tumors
Official title: Patient Satisfaction With Placement of Implantable Venous Access Devices
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Unspecified Adult Solid Tumor, Protocol Specific
Keywords: unspecified adult solid tumor, protocol specific
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-04-05
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: RATIONALE: Gathering information about patients with solid tumors who have implantable venous access devices may help doctors learn more about patient satisfaction.

PURPOSE: This phase I trial is studying satisfaction with placement of implantable venous access devices in patients with solid tumors.

Detailed description: OBJECTIVES:

* To determine patient satisfaction with subcutaneous venous-access device placement in oncology patients.

OUTLINE: Patients complete a computer-based survey while in the treatment area of the Vanderbilt Oncology Clinic. Basic demographic information and basic information regarding the placement of the device and complications are collected from the patient's medical record.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of a solid tumor malignancy

  * No hematological malignancy
* Patient at the Vanderbilt Oncology Clinic
* Has undergone placement of a subcutaneous, single-lumen venous-access device within the past 6 months

  * No patients who have had ≥ 2 venous-access devices placed by ≥ 1 department

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* Not currently undergoing preparation for or process of stem cell transplantation

Primary outcomes:
measure: Overall satisfaction with port placement
timeFrame: n/a - study closed
Secondary outcomes:
measure: Frequency of complications
measure: Frequency of port failure
measure: Need for removal of device
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center - Cool Springs
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: Kristin Ancell, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02698943: Glistenings and PCO Evaluation for the Envista MX60
Official title: Evaluation of Glistenings and Posterior Capsule Opacification Following Envista MX60 Intraocular Lens Implantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Keywords: cataract; intraocular lens; posterior capsule opacification; glistening; ENVISTA
Lead sponsor: Democritus University of Thrace
Sponsor class: OTHER
First posted: 2016-03-04
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with senile cataract

Brief summary: Posterior capsule opacification (PCO) and glistenings development is among the primary reasons for sub-optimal visual capacity following cataract extraction surgery. Primary objective of this study is to evaluate the incidence of PCO and glistenings of the popular envista MX-60 intraocular lens (Bausch + Lomb) in a random sample of cataract patients who underwent phacoemulsification at least 1 year prior to their enrollment at the study


Eligibility criteria: Inclusion Criteria:

Diagnosis of senile cataract with stage 3 nuclear opalescence according to the Lens Opacities Classification System III (LOCS-3) grading scale

Exclusion Criteria:

Endothelial cell count less than 1900, glaucoma, IOP-lowering medications, former incisional surgery, former diagnosis of corneal disease, diabetes or autoimmune diseases

Primary outcomes:
measure: Glistenings
timeFrame: 1 year
measure: Posterior capsule Opacification (PCO)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assistant Professor
name: Georgios Labiris, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03398343: Nutritional Therapy on Underweight Critically Ill Patients: an Observational Study
Official title: Nutritional Therapy on Underweight Critically Ill Patients: an Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Underweight
Critical Illness
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2018-01-12
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critically ill patients with body mass index (BMI) inferior to 20 kg/m2

Brief summary: Critically ill patients with body mass index (BMI) inferior to 20 kg/m2 have worse outcomes compared to normal and overweight patients. The impact nutrition therapy in this population is not yet stablished. There is a concern that too low caloric intake might worse their malnutrition; on the other hand, overfeeding is always a risk with serious consequences.

The hypothesis of this study is that nutritional support, especially caloric and protein intake, can influence the outcome of underweight critically ill patients.


Eligibility criteria: Inclusion Criteria:

* Ages eligible for study: 18 years and older
* Gender eligible: both
* Nutrition therapy: enteral, parenteral feeding, nothing by mouth

Exclusion Criteria:

* Palliative care
* Exclusively oral nutrition
* Pregnancy
* Life expectancy inferior 24 hours
* ICU readmission

Primary outcomes:
measure: Mortality
timeFrame: through study completion (up to a year)
Secondary outcomes:
measure: ICU length of stay
timeFrame: through study completion (up to a year)
measure: Need and duration of mechanical ventilation
timeFrame: through study completion (up to a year)
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: HCPA, Hospital de Clinicas de Porto Alegre
state: Rio Grande Do Sul
Study officials:
References:
citation: Viana MV, Tavares AL, Gross LA, Tonietto TA, Costa VL, Moraes RB, Azevedo MJ, Viana LV. Nutritional therapy and outcomes in underweight critically ill patients. Clin Nutr. 2020 Mar;39(3):935-941. doi: 10.1016/j.clnu.2019.03.038. Epub 2019 Apr 5.
Clinical trial NCT03676543: Mutual Interactions Between Absence Epilepsy Seizures and the Integration of Sensory Stimuli
Official title: Mutual Interactions Between Absence Epilepsy Seizures and the Integration of Sensory Stimuli
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Childhood or Juvenile Absence Epilepsy
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2018-09-18
Enrollment: 1
Sex: ALL
Minimum age (years): 2
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Epileptic seizures arise from neuronal defects that often alter the capacity of the brain to process sensory information. During absence seizures, a frequent epileptic syndrome in children, the normal conscious and perceptual processes are temporarily interrupted. This is the result of abnormal synchronized neural activities in the thalamo-cortical loops, leading to bilateral spike-and-wave discharges (SWDs) in the cortical electroencephalograms (EEGs). The brain mechanisms underlying the lack of sensory experience during absence seizures are disputed. Based on preliminary data, the investigators hypothesize that the alternation of 'spike' and 'wave' patterns during seizure could cause a time-to-time inconstancy in cortical responsiveness, preventing conscious perception. Using a real-time closed-loop stimulation system, the investigators will research how the S- and W-patterns specifically alter the sensory-evoked responses in the EEG. During a standard EEG, visual stimulations will be applied between and during absence seizures to test the hypothesis that repeated sensory stimuli, applied with an appropriate timing relative to the seizure-related oscillatory cycle, could negatively interfere with the regenerative network mechanisms involved in the occurrence of SWDs. The completion of this project should permit to unveil a new neuronal mechanism supporting the lack of conscious experience during absences and pave the way for new clinical non-invasive strategies to interrupt ongoing seizure activity.


Eligibility criteria: Inclusion criteria :

* Age 2-20 years
* childhood or juvenile absence epilepsy defined by International Ligue Against Epilepsy (ILAE)
* Electroencephalogram (EEG) indicated for clinical follow-up

Non inclusion criteria:

* Visual deficit
* Abnormal Magnetic Resonance Imaging (MRI)
* Medical history of photosensitive epileptic seizures

Primary outcomes:
measure: Modification of the frequency within the peak-wave complexes according to the repeated sensory stimulation and the duration of the absence epilespy crisis
timeFrame: 1 hour
measure: Modification of the duration of the absence epilespy crisis according to the repeated sensory stimulation
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation OPH A. de Rothschild
Study officials:
References:
Clinical trial NCT00806143: Bilateral Versus Monolateral Repetitive Transcranial Stimulation in Depression
Official title: Bilateral Versus Monolateral Repetitive Transcranial Stimulation in Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Major Depression
Keywords: Depression
TMS
Lead sponsor: Institute of Neuroscience, Florence, Italy
Sponsor class: OTHER
First posted: 2008-12-10
Enrollment: 16
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: Repetitive transcranial magnetic stimulation (rTMS) has been recently FDA approved for the treatment of resistant depression. No accordance exists on which are the involved mechanisms of action and on which stimulation parameters, frequency and side are optimal.

Detailed description: To compare these different procedures we study patients with unipolar recurrent resistant major depressive disorder in a double-blind, controlled trial randomized to either sequential bilaterally on the right and left dorsolateral prefrontal cortex (DLPFC) or monolaterally on the right DLPFC. Patients will be randomized to receive sequentially low-frequency rTMS at 1 Hz to the right DLPFC and high-frequency rTMS at 10 Hz rTMS to the left DLPFC, or to receive low-frequency rTMS at 1 Hz to the right DLPFC. Significant antidepressant effect as expressed by a reduction of Hamilton Depression Scale score will be recorded in both the groups of patients.

Eligibility criteria: Inclusion Criteria:

* Diagnostic and Statistical Manual-IV criteria for Depressive Major Episode Hamilton Rating Scale for Depression -28 (Ham-D)score ≥ 18
* Failure to respond to a minimum of two courses of antidepressant medications for at least 6 weeks

Exclusion Criteria:

* Any comorbid axis I disorder (except simple and social phobia)
* Any other significant medical, particularly neurologic, illnesses (seizures, head trauma and brain lesions)

Primary outcomes:
measure: Hamilton Depression Scale (HAM-D)
timeFrame: at baseline and 3rd week
Secondary outcomes:
measure: Clinical Global Impression Scale (CGI)
timeFrame: baseline and 3rd week
Other outcomes:
Locations:
city: Florence
country: Italy
facility: Institute of Neuroscience
Study officials:
affiliation: Istituto di Neuroscienze
name: Stefano Pallanti, md
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pallanti S, Bernardi S, Di Rollo A, Antonini S, Quercioli L. Unilateral low frequency versus sequential bilateral repetitive transcranial magnetic stimulation: is simpler better for treatment of resistant depression? Neuroscience. 2010 May 5;167(2):323-8. doi: 10.1016/j.neuroscience.2010.01.063. Epub 2010 Feb 9.
Clinical trial NCT06619743: HPV Infection and Vaginal Microecology in Immunosuppressed Women
Official title: Study on HPV Infection and Vaginal Microecology in Immunosuppressed Women
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: HIV Infections
HPV Infection
Cervical Cancer
Anal Cancer
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2024-10-01
Enrollment: 10000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV-infected women

Brief summary: This study intends to establish a screening cohort for HPV infection and related tumors in areas with high incidence of HIV infection, explore the screening of cervical cancer and anal cancer and the prognosis management model of precancerous lesions in HIV-infected women, and provide a scientific basis for the formulation of malignant tumor screening policies for this population in my country. In addition, this study intends to characterize the cervical, vaginal, and intestinal microecological characteristics of women with different HIV/HPV infection status, so as to explore the impact of cervical, vaginal, and intestinal microecological characteristics on persistent HPV infection or CIN/cancer progression.


Eligibility criteria: Inclusion Criteria:

* HIV positive female, ≥18 years old
* HIV infection is sexually transmitted
* Have an intact cervix
* Have not received cervical cancer screening in the past 1 year
* No previous treatment for CIN/cervical cancer
* No clinical pregnancy symptoms

Exclusion Criteria:

* Women who have had a previous cervical resection
* Unable to complete all screening processes independently
* Unable or unwilling to accept follow-up
* For subjects in vaginal microecology studies, women who used antibiotics within 2 weeks before collecting vaginal secretions, had sexual intercourse within 3 days, or used vaginal medication or vaginal douching within 48 hours need to be further excluded.

Primary outcomes:
measure: Detection rate of cervical intraepithelial neoplasia grade 2 or above (CIN2+) in women infected with HIV within 5 years
timeFrame: 5 years
measure: Detection rate of cervical intraepithelial neoplasia grade 3 and above (CIN3+) in women infected with HIV within 5 years
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03129243: Sperm DNA Damage to Intracytoplasmic Sperm Injection Outcome
Official title: Relation of Sperm DNA Damage to Intracytoplasmic Sperm Injection Outcome in Couples With Male Infertility
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility, Male
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-04-26
Enrollment: 120
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will include all infertile couples undergoing intracytoplasmic sperm injection in The Department of Dermatology and Andrology with assisted reproductive unit at women's health hospital, Assiut University Hospital.

Brief summary: In the current era of assisted reproductive techniques where technology can help overcome defects in sperm function, the value of semen analysis has become even more inaccurate. Initial reports of intracytoplasmic sperm injection revealed its ability to bypass the natural selection process and enable men with severely impaired semen parameters to achieve both clinical pregnancy and live birth


Eligibility criteria: Inclusion Criteria:

1. Infertile male patients with abnormal semen parameters.
2. Normal female partner aged \<38 years.

Exclusion Criteria:

1. Female patients with obvious infertility factor.
2. Male patients with azoospermia.
3. Male patients with systemic diseases.
4. Male patients receiving cytotoxic therapy.
5. Male patients with genital pathology as cryptorchidism.

Primary outcomes:
measure: clinical pregnancy rate
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Ahmed Abbas
state: Cairo
Study officials:
References:
Clinical trial NCT05267743: Study to Confirm the Safety and Efficacy of Tegoprazan in Patients With Healed Erosive Reflux Disease
Official title: A Multicenter, Double-blind, Randomized, Active-controlled Phase 4 Study to Evaluate the Efficacy and Safety of Tegoprazan in Patients With Erosive Reflux Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Erosive Reflux Disease
Lead sponsor: HK inno.N Corporation
Sponsor class: INDUSTRY
First posted: 2022-03-04
Enrollment: 218
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to evaluate the efficacy and safety of Tegoprazan 50mg, compared to Lansoprazole 30mg in patients with healed erosive reflux disease confirmed by endoscopy following oral administration once daily(QD) of 2 weeks or 4 weeks.

Detailed description: This is a double blind, radomized, active-controlled, phase 4 study. Subjects will be randomly assigned to one of the two treatment groups (Tegoprazan 50mg, Lansoprazole 30mg)

Eligibility criteria: Inclusion Criteria:

1. Erosive eshophagitis(LA calssfication Grades A to D) with in 30 days prior to Randomization
2. Those who have experienced heartburn symptoms within 7 days prior to Visit 1(screening date)

Exclusion Criteria:

1. Unalbe to undergo upper GI endoscopy
2. H. pylori positive
3. Those who cannot write a clinical trial subject diary
4. Presence of esophageal stricture, ulcerated stricture, gastroesophageal varix, long segment Barrett's esophagus with \>3cm length(LSBE), eosinophilic oesophagitis, active digestive ulcer or gastric bleeding on an upper GI endoscopy

Primary outcomes:
measure: 4 weeks cumulative ERD healing rate(%)
timeFrame: 4 weeks
Secondary outcomes:
measure: 2 weeks ERD healing rate(%)
timeFrame: 2 weeks
measure: Healing rate(%) at 2 weeks and 4 weeks according to CYP2C19 genotype type
timeFrame: 2 weeks or 4 weeks
measure: Percentage of days without heartburn through the clinical trial subject dairy (%)
timeFrame: 2 weeks or 4 weeks
measure: RDQ (Reflux Disease Questionnaire) evaluation(mean change in severity)
timeFrame: 2 weeks or 4 weeks
measure: Incidence of Adverse Events [Safety]
timeFrame: 2 weeks or 4 weeks
Other outcomes:
Locations:
city: Iksan
country: Korea, Republic of
facility: Wonkwang University Hospital
state: Muwang-ro 895
Study officials:
affiliation: Wonkwang University Hospital
name: Suk Chae Choi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01500343: A Pilot Study of Probiotic Saccharomyces Boulardii Use in Chronic Heart Failure Patients. Estudo PROICA
Official title: A Pilot Study of Probiotic Saccharomyces Boulardii Use in Chronic Heart Failure Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Heart Failure
Keywords: heart failure
probiotics
Saccharomyces boulardii
cardio-intestinal syndrome
gut
inflammation
Lead sponsor: Universidade Federal Fluminense
Sponsor class: OTHER
First posted: 2011-12-28
Enrollment: 20
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 this study is to evaluate the feasibility, safety and effects in inflammatory response of the therapy with a probiotic agent, the yeast Saccharomyces boulardii (SB), in chronic heart failure patients.

Detailed description: A cardiointestinal syndrome has been described in heart failure patients, with morphologic and functional intestinal disorders, increased enteropathogenic bacteria concentration, bacterial translocation and inflammatory activation, thus contributing for clinical worsening and progression of the disease.

In clinical practice, probiotics has been used in several different conditions, as inflammatory bowel diseases, acute and antibiotic-associated diarrhea, food allergies, and cancer, showing benefits in inflammation and reducing bacterial translocation. However, the use of probiotics in heart failure has never been described.

Eligibility criteria: Inclusion Criteria:

* Class I or II (NYHA)heart failure patients

Exclusion Criteria:

* Corticosteroid use within 30 days
* NSAID use within 30 days
* Antibiotic use within 30 days
* Acute infections
* Inflammatory diseases
* Autoimmune diseases
* Cancer
* Intestinal diseases
* Chronic renal failure

Primary outcomes:
measure: Analysis of biochemical profile (high-sensitivity C reactive protein, total leukocyte count and uric acid seric levels)
timeFrame: 3 months
Secondary outcomes:
measure: Analysis of cardiac remodelling
timeFrame: 3 months
measure: Analysis of creatinine seric levels
timeFrame: 3 months
Other outcomes:
Locations:
city: Niteroi
country: Brazil
facility: Hospital Universitário Antonio Pedro
state: Rio de Janeiro
Study officials:
affiliation: Universidade Federal Fluminense
name: Annelise C Costanza, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidade Federal Fluminense
name: Evandro T Mesquita, MD,PhD
role: STUDY_DIRECTOR
References: