louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00953693: Patient Specific Induced Pluripotency Stem Cells (PSiPS)
Official title: Patient Specific Induced Pluripotency Stem Cells (PSiPS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatic Disorders
Eye Disorders
Keywords: Induced pluripotent stem cells
Hepatic disorders
Eye disorders
Blood groups
Lead sponsor: Royan Institute
Sponsor class: OTHER_GOV
First posted: 2009-08-06
Enrollment: 15
Sex: ALL
Minimum age (years): 12
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patient who suffering from metabolic disorders

Brief summary: Induced pluripotent stem cells (iPSCs) are adult cells that have been genetically reprogrammed to an embryonic stem cell-like state by being forced to express genes and factors important for maintaining the defining properties of embryonic stem cells. The reprogramming of adult cells into embryonic stem (ES) cells enables the generation of patient-specific stem cells and thus has enormous potential for the treatment and analysis of degenerative diseases. In this project the investigators are going to induce pluripotent stem cells from cell cultures from skin biopsies of patients. The iPS cells will be developed for modeling diseases and drug discovery as well as basic research.

Detailed description: iPS cells are typically derived by transfection of certain stem cell-associated genes into non-pluripotent cells, such as adult fibroblasts. Transfection is typically achieved through viral vectors, such as retroviruses. Transfected genes include the master transcriptional regulators Oct-3/4 (Pouf51) and Sox2, although to enhance the efficiency of induction some other genes e.g. Klf4, c-Myc. In this study after separation the fibroblasts from patient's skin biopsy, the cells are transfected with 4 Yamanaka factors (human Oct4, Sox2, Klf4, c-Myc) after 3-4 weeks, transfected cells are isolated through morphological selection.

Eligibility criteria: Inclusion Criteria:

* Donors suffering from different (specified) metabolic disorders
* Donors suffering from different (specified) eye disorders which resulted to blindness
* Special blood group: O Bombay

Exclusion Criteria:

* None

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Royan Institute
Study officials:
affiliation: Royan Institute
name: Hamid Gourabi, PhD
role: STUDY_CHAIR
affiliation: Royan Institute
name: Hossein Baharvand, PhD
role: STUDY_DIRECTOR
References:
citation: Seifinejad A, Taei A, Totonchi M, Vazirinasab H, Hassani SN, Aghdami N, Shahbazi E, Yazdi RS, Salekdeh GH, Baharvand H. Generation of human induced pluripotent stem cells from a Bombay individual: moving towards "universal-donor" red blood cells. Biochem Biophys Res Commun. 2010 Jan 1;391(1):329-34. doi: 10.1016/j.bbrc.2009.11.058. Epub 2009 Nov 11.
Clinical trial NCT04111393: Transoral Removal of Specimen During Laparoscopic Gastric Resection
Official title: Transoral Removal of Specimen During Laparoscopic Gastric Resection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Disease
Bariatric Surgery Candidate
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2019-10-01
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients who underwent sleeve gastrectomy for morbid obesity, subtotal gastrectomy for pyloric obstruction, and extensive gastric resection for gastrointestinal stromac tumor

Brief summary: Investigators aimed to present the patients who underwent laparoscopic gastrectomy with transoral specimen extraction.

Detailed description: Minimally invasive surgical procedures such as NOSE (Natural orifice spesmen extraction) and NOTES (Natural orifice translumenal endoscopic surgery) are gradually increasing. The transoral way is probably the least used for NOSE.

Eligibility criteria: Inclusion Criteria:

* laparoscopic gastric resection
* Patients aged 18-70 years

Exclusion Criteria:

* other transorally removed organs (appendix, gallbladder, surrenal)

Primary outcomes:
measure: Transoral Specimen Extraction During Laparoscopic Gastric Resection
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Malatya
country: Turkey
facility: Cihan Gokler
Study officials:
References:
Clinical trial NCT00029211: A Trial of Echinacea in Children
Official title: A Randomized Controlled Trial of Echinacea in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Common Cold
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
Collaborators: name: Office of Dietary Supplements (ODS)
First posted: 2002-01-10
Enrollment: 600
Sex: ALL
Minimum age (years): 2
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized trial to determine if echinacea is effective in shortening the length and/or lessening the severity of colds in children 2 through 11 years old.

Detailed description: Upper respiratory tract infections (URI's) are a significant health burden in childhood. URI's are a major reason for visits to health care providers, and up to 35 percent of young children at any given time are taking some over-the-counter cold medication. Unfortunately, data suggest that most of these medications have limited effectiveness. Alternative medical therapies are growing in popularity; in a recent survey of parents of children being seen by pediatricians in Seattle, Washington, 24.2 percent indicated that their child had been seen by an alternative medicine health care provider, and 53.3 percent received therapies for the treatment of URI's in children. The proposed study is a randomized, double blind, placebo controlled trial of Echinacea for the treatment of URI's in children 2-11 years old. The aims of the project are: to determine if Echinacea shortens the duration and/or lessens the severity of URI's, if children receiving Echinacea for treatment of URI's have a reduced rate of secondary bacterial infections, and to determine if the use of Echinacea in patients 2-11 years old is associated with any significant side effects. A two-year study of 600 children is planned. Not only will the results of this study determine if Echinacea, the most popular medicinal herb sold in the United States, is an effective therapy for URI's in children, the study will provide a design framework for further assessment on the efficacy of other complementary and alternative medicines in children.

Eligibility criteria: Inclusion Criteria:

* Parent available to observe child during the night
* Parent peaks and reads English

Exclusion Criteria:

* History of asthma or allergic rhinitis
* History of auto-immune disease
* History of chronic lung disease
* Allergy to sunflower species

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Child Health Institute, University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: James Taylor, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02689011: Incidence of Urinary Retention in Patients Undergoing Unilateral Total Knee Arthroplasty- Comparison Between Continuous Epidural Analgesia and Single Shot Femoral Nerve Block- a Randomized Controlled Study (UriKANE)
Official title: Incidence of Urinary Retention in Patients Undergoing Unilateral Total Knee Arthroplasty- Comparison Between Continuous Epidural Analgesia and Single Shot Femoral Nerve Block- a Randomized Controlled Study (UriKANE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Pain
Urinary Retention
Post Operative Pain
Keywords: Total Knee Arthroplasty
Femoral Nerve Block
Epidural Analgesia
Urinary Retention
Lumbar Epidural
Lead sponsor: Aga Khan University
Sponsor class: OTHER
First posted: 2016-02-23
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This study aims to compare the incidence of urinary retention and requirement of bladder catheterization in patients undergoing total knee arthroplasty while receiving either continuous epidural analgesia or single shot femoral nerve block.


Eligibility criteria: Inclusion Criteria:

* ASA Physical status I, II \& III
* Male and Female Patients age between between 30 and 70 years
* Unilateral Total Knee Arthroplasty

Exclusion Criteria:

* Patient Refusal
* Allergy to local anesthetics, paracetamol or other study drugs
* History of opioid dependence
* Contraindications to spinal/epidural anesthesia and femoral nerve block (coagulation defects, infection at puncture site etc.)
* Inability to use patient-controlled analgesia (IV PCIA) (as assessed at the time of informed consent)
* History of urinary retention, neurogenic bladder, or any urologic problem

Primary outcomes:
measure: Incidence of urinary retention
timeFrame: 24 Hours
Secondary outcomes:
measure: Mean post-operative nausea and vomiting scores
timeFrame: up to 48 hours
measure: Mean post-operative sedation scores
timeFrame: up to 48 hours
measure: Mean post-operative pain scores
timeFrame: up to 48 hours
measure: Surgical outcomes - maximal knee flexion
timeFrame: up to 48 hours
measure: Surgical outcomes - duration of post-operative hospital stay
timeFrame: up to 48 hours
measure: Surgical outcomes - mobilization out of bed
timeFrame: up to 48 hours
measure: Surgical outcomes - food intake
timeFrame: up to 48 hours
measure: Patient satisfaction
timeFrame: 7 Days
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Aga Khan University
Study officials:
affiliation: Aga Khan University
name: Ausaf A Khan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00002311: The Safety of Four Different Dose Levels of Wobenzym in HIV-Positive Patients
Official title: A Phase I-II Dose Escalation Study to Examine the Safety of Four Doses of Wobenzym in HIV Seropositive Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Keywords: Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Wobenzym
Hydrolases
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To study the safety and efficacy of four different doses of Wobenzym (an enzyme combination consisting of pancreatin, papain, bromelain, trypsin, lipase, amylase, chymotrypsin, and rutin) in patients with HIV infection whose CD4 count is between 250 and 400 cells/mm3. To evaluate the effect of Wobenzym on certain surrogate markers associated with progression of HIV disease.


Eligibility criteria: Inclusion Criteria

Patients must have:

HIV seropositivity with CD4 counts between 250 and 400 cells/mm3.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Known hypersensitivity to hydrolytic enzymes such as Wobenzym.
* Known sensitivity to lactose.
* Presumption that the patient will not comply with the dosing schedule or follow-up appointments.

Concurrent Medication:

Excluded:

* Concurrent use of immunosuppressive therapy or steroids.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Saint Luke's - Roosevelt Hosp Ctr
state: New York
Study officials:
References:
Clinical trial NCT04796311: Imunomodulation in Acute Pancreatitis
Official title: Imunomodulation in Acute Pancreatitis- How Can Cytokines, B and T Cells Predict the Outcome of the Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Pancreatitis
Lead sponsor: Hospital da Luz, Portugal
Sponsor class: OTHER
First posted: 2021-03-12
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: hospitalized patients with acute pancreatitis from 18 to 85 years old

Brief summary: Acute pancreatitis is an acute inflammatory pathology of the pancreas with activation of both innate and adaptive immune system, including T and B lymphocytes and release of inflammatory cytokines. We aim to characterize the circulating profile of T and B cells, its regulatory populations and B cell maturation, as well as inflammatory cytokines, in a prospective way of 50 patients with acute pancreatitis admitted to Hospital da Luz Lisboa. Blood samples will be collected at hospital admission, 48h, one month and 6 months after hospitalization of patients, relating these values to the severity of acute pancreatitis. Patients with acute pancreatitis in the previous 6 months, diabetes mellitus, pregnant women, uncontrolled comorbidity and terminal neoplasms will be excluded. A control group of 30 ambulatory individuals observed at the Hospital da Luz Lisboa will be recruited. Laboratory evaluation will be performed at the Immunology Laboratory of NOVA Medical School.


Eligibility criteria: Inclusion Criteria:

* hospitalized patients with acute pancreatitis

Exclusion Criteria:

* acute pancreatitis in the last 6 months diabetes mellitus, pregnant women, uncontrolled comorbidity such as organ disease (cardiac, renal, hepatic) and terminal neoplasms

Primary outcomes:
measure: To characterize the immune profile of patients with acute pancreatitis at admission, 48h after admission and at 1 month and 6 months after discharge.
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Lisbon
country: Portugal
facility: Hospital da Luz
Study officials:
affiliation: Hospital da Luz, Lisboa
name: Filipa Malheiro, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05396911: Development of UP2UTobacco for High School Youth
Official title: Testing an Anti-Tobacco Intervention to Reduce Tobacco and Nicotine Use Among High School Students
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Tobacco Use Cessation
Tobacco Use
Electronic Cigarette Use
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: Virginia Foundation for Healthy Youth
First posted: 2022-05-31
Enrollment: 432
Sex: ALL
Minimum age (years): 14
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Tobacco use is increasing among youth in the U.S. However evidence for the long-term effectiveness of tobacco cessation programs for youth is limited. The current study seeks to adapt and evaluate a universal group-based youth brief tobacco intervention for 9th grade students.

This study will use a sequential, multi-method research design beginning with qualitative roundtable discussions with 9th grade students to adapt an existing young adult brief tobacco intervention for youth. Roundtable discussions with students will identify salient intervention themes and strategies for targeting the intervention and developing the text messages. The second phase of the study evaluates the brief intervention, UP2UTobacco, through a cluster randomized controlled trial that compares UP2UTobacco to a no treatment control. It is hypothesized that the UP2UTobacco will produce greater abstinence at the 6-month follow-up compared to the no treatment control.

Roughly 90% of daily smokers started before the age of 18, and 2,000 youth smoke a cigarette for the first time each day in the U.S. Additionally, e-cigarette use is on the rise among youth, and is linked to cigarette initiation among tobacco naïve youth. In order to curb the rise of tobacco use among youth, interventions that are easily implemented and easily disseminated need to be developed for youth addressing currently available products and contemporary patterns of use. If the interventions in the current study are proven efficacious, they can easily be disseminated to other schools to continue reducing youth tobacco use.


Eligibility criteria: Inclusion Criteria:

* Enrolled in the selected physical education or health class selected for participation in the study.

Exclusion Criteria:

* None

Primary outcomes:
measure: Past 30-day point prevalence abstinence
timeFrame: past 30-day
Secondary outcomes:
measure: Past 7-day point prevalence abstinence
timeFrame: past 7 days
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
References:
Clinical trial NCT03355911: Preoperative Corneal Thickness and Postoperative Visual Outcomes After Posterior Lamellar Corneal Transplant
Official title: Relationship Between Preoperative Corneal Thickness and Postoperative
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Corneal Changes of Membranes
Lead sponsor: Centre Hospitalier Régional Metz-Thionville
Sponsor class: OTHER
First posted: 2017-11-28
Enrollment: 113
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients underwent posterior lamellar graft during the study period.

Brief summary: To evaluate the impact of preoperative corneal thickness on visual outcomes following Descemet's stripping endothelial keratoplasty (DSAEK) or Descemet membrane endothelial keratoplasty (DMEK)

Detailed description: Patients underwent DSAEK or DMEK for endothelial dysfunction, from October 2013 to November 2016. Patients aged \> 18 years and with an indication for posterior lamellar graft surgery, such as Fuchs dystrophy, were included. Exclusion criteria included a history of penetrating keratoplasty in the study eye and a need for a penetrating keratoplasty following endothelial graft failure. Visual acuity, central corneal thickness (CCT) and graft thickness were measured preoperatively, and at postoperative day 7 and months 1, 3 and 6.

Eligibility criteria: Inclusion Criteria:

* Clinically indicated need for posterior lamellar graft surgery (DSAEK or DMEK) such as:

  * Fuchs dystrophy,
  * pseudophakic bullous decompensation
  * or other endothelial dysfunction corneal

Exclusion Criteria:

* were a history of penetrating keratoplasty in the indicated eye
* the technical inability of preoperative CCT measurement
* the need for a penetrating keratoplasty following endothelial graft failure
* severe postoperative complications resulting in unquantifiable visual acuity

Primary outcomes:
measure: Descemet's stripping endothelial keratoplasty (DSAEK) or Descemet membrane endothelial keratoplasty (DMEK)
timeFrame: month 6
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00466011: Validation of the Stardust Cardio-Respiratory Recorder
Official title: Validation of the Stardust Cardio-Respiratory Recorder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea
Lead sponsor: Associação Fundo de Incentivo à Pesquisa
Sponsor class: OTHER
Collaborators: name: Philips Respironics
First posted: 2007-04-27
Enrollment: 80
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Ambulatory patients with complains of OSA

Brief summary: Introduction: The full night polysomnography (PSG) in sleep lab is the gold standard to Obstructive Sleep Apnea (OSA) diagnosis. However, there is a need to evaluate simple and accurate home diagnostic equipment that can reliably detect or exclude OSA. The aim of our study was to evaluate if an ambulatory portable monitor (SD) is accurate to measure apnea-hypopnea index (AHI) in OSA patients referred to a Sleep Lab. Methods: Patients with clinical suspicion of OSA were selected. Three-order randomized evaluations had been performed within a period of two weeks: the 1) SD (Stardust®, Respironics, Inc, USA) was used at patients home (SD home), 2) SD was used simultaneously with PSG in the sleep lab (SD+PSG lab) and 3) PSG was performed without the use of SD (PSG lab). Four AHI were generated and analyzed: AHI from SD home, AHI from SD of SD+PSG lab, AHI from PSG of PSG+SD lab and AHI from PSG lab. The analyses of SDs and PSGs recordings were performed by two blinded technicians.


Eligibility criteria: Inclusion Criteria:

* Patient referred to Sleep Disorder Center because of:

  * Excessive daytime sleepiness,
  * Loud snoring,
  * Witnessed apnea.
* Patient with ability to provide consent, ability and willingness to follow study procedures.

Exclusion Criteria:

* Suspicion of insomnia,
* Restless leg syndrome,
* Periodic limb movements; or
* Other non-OSA sleep disorders.
* Patient experiencing acute illness, patients who are medically complex, and patients requiring supplemental oxygen or mechanical ventilation.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: AFIP
state: SP
city: São Paulo
country: Brazil
facility: AFIP
state: SP
Study officials:
affiliation: Associacao Fundo de Incentivo a Psicofarmcologia
name: Sergio Tufik, MD, PhD
role: STUDY_DIRECTOR
References: