louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01314846: Co-culture and Advanced Maternal Age in PGS Program
Official title: Co-culture Versus Sequential Culture System in Advanced Maternal Age.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Age Factors
Lead sponsor: IVI Madrid
Sponsor class: OTHER
First posted: 2011-03-15
Enrollment: 346
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 47
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women over 39 years old undergoing a PGS cycle

Brief summary: Fertilization and embryo development in vivo occurs in appropriate conditions in the mammalian reproductive tract. However in assisted reproductive technology (ART) embryos and oocytes are exposed to certain factors such as temperature, O2 pressure and pH fluctuations that may affect embryo development and viability in vitro. In Preimplantation Genetic Screening program (PGS) the investigators need to culture the embryos until day 5 so the requirement of culture techniques must be optimal to produce acceptable blastocyst rates. As it has been shown before, embryo culture conditions have the potential to impact biopsied embryos and hence PGS success rates.

Nowadays the coculture system with endometrial cells could be an alternative option to improve the blastocyst rates since some publications have indicated that endometrial cells may provide trace elements and growth factors that are not present in defined culture media and reproduce physiologic conditions. Although the role of coculture in vitro fertilization (IVF) has been controversial, a recent meta-analysis has established the potential benefits of coculture system.

The aim of this study was to compare embryologic and clinical outcomes in terms of blastocyst, implantation and pregnancy rates to evaluate endometrial epithelial cell (EEC) coculture versus sequential culture system in advanced maternal age ( ≥39 years) in the PGS program.


Eligibility criteria: Inclusion Criteria:

* Advanced maternal age (\>39) undergoing PGS cycle

Exclusion Criteria:

* Other PGS indication
* Altered karyotype

Primary outcomes:
measure: implantation rate
timeFrame: from February 2009 to December 2010
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: IVI Madrid
Study officials:
References:
Clinical trial NCT00538746: Effect of Increased Muscular Work During Different Weaning Strategies in Critically Ill Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Respiratory Failure
Lead sponsor: Università degli Studi dell'Insubria
Sponsor class: OTHER
First posted: 2007-10-03
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Most patients admitted to intensive care units require mechanical ventilation. Weaning from assisted/controlled ventilation begins when we recognize that the patient has recovered adeguately from acute respiratory failure.

If weaning is delayed, costs are increased, as are the risks of nosocomial pneumonia, cardiac-associated morbility, and death. On the other hand, weaning too soon often results in reintubation, which is associated with complications similar to those of prolonged ventilation.

The aim of this trial is to establish an evidence-based approach to weaning and to determine when a patient is ready to be weaned from mechanical ventilation, and what is the best weaning technique.


Eligibility criteria: Inclusion Criteria:

1. Age higher than 18 yrs
2. PaO2/FiO2 greater or equal than 150 with PEEP equal or lower than 10, and minute ventilation lower than 15 l/min
3. Temperature lower than 38,5°C
4. Stable hemodynamics: HR 60-125 b/min, SBP 90-160 mmHg without or with dopamine lower than 10 gamma/Kg/min or dobutamine lower than 10 gamma/Kg/min, no acute arrythmias
5. Hb higher than 8 g/dl
6. GCS higher or equal than 9
7. The attending physician has to agree that the patient is in stable conditions and ready to be weaned from the ventilator

Exclusion Criteria:

1. presence of chronic neuromuscular diseases
2. need of surgical intervention within the next 72 hours
3. difficult tracheal intubation
4. tracheostomized patients

Primary outcomes:
measure: 1. Days of intubation 2. Days of mechanical ventilation
timeFrame: 28 days
Secondary outcomes:
measure: 1. The day of eventual tracheostomy 2. Organ Failure 3. The mortality at 28° day 4. Outcome at 6 months
timeFrame: 1 year
Other outcomes:
Locations:
city: Varese
country: Italy
facility: Ospedale di Circolo e Fondazione Macchi
Study officials:
affiliation: Universita' degli Studi dell'Insubria
name: Paolo Pelosi, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01404546: Cost Free Pharmacotherapy for Smoking Cessation in Stroke Patients
Official title: A Randomized Controlled Pilot Study of Standardized Counselling and Cost-free Pharmacotherapy for Smoking Cessation Among Stroke and TIA Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: stroke smoking cessation cost-free pharmacotherapy
Lead sponsor: Ottawa Heart Institute Research Corporation
Sponsor class: OTHER
First posted: 2011-07-28
Enrollment: 28
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: This pilot study examined the effect of providing a 4 weeks of cost free quit smoking medications to smokers identified in a stroke prevention clinic who were interested in quitting smoking compared to providing a prescription for the medication only.

Detailed description: DESIGN: Randomized controlled trial. METHODS: All patients seen at the Ottawa Hospital Stroke Prevention Clinic were screened for smoking status, advised to quit smoking and treated using a standardized protocol including counselling and pharmacotherapy. Eligible smokers were randomly assigned to either a prescription only usual care group, or, the experimental group who received a 4-week supply of cost-free quit smoking medications and prescription for medication renewal. All patients received follow-up counselling 7-days prior to and 5, 14, 30, 60, 90, 180 days following their quit attempt. Levels of eligibility, consent, adherence and retention were used as indicators of study feasibility. The primary outcome was bio-chemically validated quit rates at 26-weeks.

Eligibility criteria: Inclusion Criteria:

* Patients were eligible to participate in the study if they reported smoking an average of 5 or more cigarettes per day in past 3 months; were 18 years of age or older; were willing to set a quit date in the next 30 days; and were willing to use a quit smoking medication.

Exclusion Criteria:

* Patients who were unable to read and understand English or French or who had contraindications to all approved smoking cessation medications (nicotine replacement therapy, bupropion, and varenicline) were excluded from the study.

Primary outcomes:
measure: smoking abstinence
timeFrame: 6-months
Secondary outcomes:
measure: quit attempts
timeFrame: 6-months
measure: adherence with intervention
timeFrame: 6-months
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
Study officials:
affiliation: Associate Director and Professor
name: Robert Reid, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00610246: A Study of Radiation With Sorafenib in Advanced Cancer
Official title: A Phase I Dose Escalation Study of Concurrent Low Dose Radiation With Sorafenib in Three Anatomically-based Independent Cohorts (Thorax, Abdomen, Pelvis)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancer
Keywords: Thorax
Abdomen
Pelvis
Lesion
Cancer
Radiation
Chemotherapy
Phase 1
Advanced Cancer
Sorafenib
Nexavar
BAY43-9006
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2008-02-07
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test the combination of radiation treatment and an anti-angiogenic drug called sorafenib (or BAY 43-9006 or Nexavar) to determine the effects of this combination on cancers but also on side effects of radiation treatment. This study will also determine the highest safe dose of sorafenib that can be given with radiation treatment.


Eligibility criteria: Inclusion Criteria:

* Advanced cancer not eligible for curative treatment.
* A measurable lesion in the thorax, abdomen or pelvis.
* Normal organ and bone marrow function.
* Able to receive protocol prescribed radiation. Please refer to the protocol for detailed inclusion criteria.

Exclusion Criteria:

* Overlap of treatment field with a previous radiation field.
* Inability to meet mandated normal tissue radiation dose constraints.
* Brain metastases (unless previously treated and controlled)
* Previous treatment with Sorafenib.
* Poorly controlled Hypertension.
* Unable to swallow sorafenib tablets.
* Intercurrent cardiac dysfunction.
* Uncontrolled intercurrent illness. Please refer to the protocol for detailed exclusion criteria.

Primary outcomes:
measure: Maximum Tolerated Dose
timeFrame: Outcome is measured prior to each dose escalation.
Secondary outcomes:
measure: Sorafenib with radiation treatment efficacy
timeFrame: 12 weeks from initiation of study treatment.
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
Study officials:
affiliation: Princess Margaret Hospital, Canada
name: Anthony Brade
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05685446: Gastric Volume After Drinking 175 ml of Ice Water Prior to Gastroscopy in Healthy Adult Patients
Official title: Gastric Emptying and Gastric Volume After Ingestion of 175 ml of Ice Water Prior to Elective Gastroscopy in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fasting
Perioperative Pulmonary Aspiration
Keywords: Gastroscopy
Gastric volume
Anaesthesia
Lead sponsor: Regionshospital Nordjylland
Sponsor class: OTHER_GOV
First posted: 2023-01-17
Enrollment: 50
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: Recommendation for fluid fasting is two hours prior to anaesthesia, however, less may be acceptable. The current study compares ingestion of 175 ml ice water prior to elective gastroscopy vs. standard fasting on gastric residual volume.

Detailed description: Recommendations regarding fasting requirements prior to general anaesthesia is two hours for fluids. Recent research indicates that reduced fluid fasting time may be acceptable. The current study aimed to compare ingestion of 175 ml ice water 15 minutes prior to procedure compared to standardized fasting regimen on residual gastric volumes in patients receiving elective gastroscopy, as these volumes may have implications for fasting requirements.

Eligibility criteria: Inclusion Criteria:

* Scheduled for elective gastroscopy in a medical outpatient clinic
* American Society of Anesthesiologists physical status classification system category (ASA score) I or II
* Age 18 years or above

Exclusion Criteria:

* Any increased risk of aspiration, eg. dysphagia, previous aspiration, non-fasting status, or known alcohol abuse
* Suspected delayed gastric emptying, eg. regular opioid use within three days
* Enteral pre-medication required
* Any structural gastric or esophageal diseases

Primary outcomes:
measure: Gastric residual volume
timeFrame: 15 minutes
Secondary outcomes:
measure: Nausea and dyspepsia
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Hjørring
country: Denmark
facility: Department of Anaestesia
state: North Denmark
Study officials:
affiliation: Regional Hospital of Northern Denmark, Hjørring
name: Kjeld Damgaard, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02681146: A Stepped-wedge Cluster Randomized Controlled Trial for Evaluating an Intervention in Patients With Stroke Tailored Education in Addition to Physiotherapist Treatment
Official title: A Stepped-wedge Cluster Randomized Controlled Trial for Evaluating an Intervention in Patients With Stroke Tailored Education in Addition to Physiotherapist Treatment
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Stroke
Keywords: education
physiotherapy
Lead sponsor: University of Malaga
Sponsor class: OTHER
First posted: 2016-02-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A stepped-wedge cluster design will be used, with the duration of the trial being 50 weeks. The 'stepped-wedge ' cluster randomised trial is a form of cross-over design with unidirectional cross-over ( from control to experimental ) but with randomisation of when each cluster undertakes this transition. In the stepped-wedge design, there is a staggered roll-out of the intervention, where the time and hence the sequence of units (clusters) that will start the intervention at each period is determined by random allocation.

The randomisation occurs before the start of the trial. All clusters start the trial in a control phase with no intervention being delivered at any site, then sequentially cross over from the control group to the intervention group, until all sites are receiving the intervention. Outcomes are measured on the study participants in all clusters at every time period, hence measurement of outcomes takes place at each step in the wedge; each cluster provides data points in the control and intervention conditions allowing each site to act as its own control.


Eligibility criteria: Inclusion Criteria:

* The study subjects were all patients who had been hospitalised in 8 regional hospitals of Andalusian Health Service with acute cerebral stroke, clinically stable, presented an ischaemic or haemorrhagic aetiology and clinical symptoms of hemiplegia, were selectioned to receiving physiotherapy in hospitalisation, were assisted by a caregiver, had an adequate understanding of Spanish, and had given their written informed consent.

Primary outcomes:
measure: Canadian Neurological Scale (CNS):
timeFrame: 8 weeks
Secondary outcomes:
measure: Trunk Control Test (TCT):
timeFrame: 8 weeks
measure: Motricity index (MI) of the lower and upper limbs
timeFrame: 8 weeks
measure: Barthel Index (BI)
timeFrame: 8 weeks
measure: Stroke Impact Scale-16 (SIS-16):
timeFrame: 8 weeks
measure: Modified Rankin Scale (MRS)
timeFrame: 8 weeks
measure: Multidimensional Scale of Perceived Social Support (MSPSS)
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
References:
citation: Crocker TF, Brown L, Lam N, Wray F, Knapp P, Forster A. Information provision for stroke survivors and their carers. Cochrane Database Syst Rev. 2021 Nov 23;11(11):CD001919. doi: 10.1002/14651858.CD001919.pub4.
Clinical trial NCT05032612: Effects of Photobiomodulation on Postoperative Pain After Primary Endodontic Therapy in Molars With Symptomatic Apical Periodontitis
Official title: Effects of Photobiomodulation on Postoperative Pain After Primary Endodontic Therapy in Molars With Symptomatic Apical Periodontitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Keywords: endodontic treatment
mandibular molar teeth
apical periodontitis.
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2021-09-02
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate the effects of photobiomodulation (PBM) on postoperative pain after endodontic treatment in mandibular molar teeth diagnosed with symptomatic apical periodontitis.


Eligibility criteria: Inclusion Criteria:

* Posterior mandibular molars
* No previous root canal therapy on the tooth in question
* Able to complete the endodontic treatment in one visit

Exclusion Criteria:

* Maxillary teeth, mandibular anteriors and premolars
* Infection (swelling, sinus tract) on the tooth in question
* Periodontal disease on the tooth in question
* Dental trauma
* Crown/ root fractures
* Systemic diseases
* Immunocompromised patients

Primary outcomes:
measure: Pain as Assessed by the Visual Analog Scale
timeFrame: 72 hours after treatment
Secondary outcomes:
measure: Pain as Assessed by the Visual Analog Scale
timeFrame: 0 hours, 6 hours, 12 hours and 24 hours hours after treatment
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Ryne Jackson, DMD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01826812: Impairment of Reading Ability in Dry Eye Patients
Official title: Functional Impairment of Reading Ability in Dry Eye Patients and Effects of Sustained Reading on the Ocular Surface
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dry Eye Syndromes
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Allergan
First posted: 2013-04-09
Enrollment: 200
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with known dry eye as well as normal healthy control subjects with no ocular surface diseases will be recruited from the Ocular Surface Diseases and Dry Eye Clinic as well as Glaucoma Clinic of the Wilmer Eye Institute.

Brief summary: To assess the reading function impairment in patients with dry eye and to assess the effects of reading on the ocular surface.

Detailed description: This study is being done to understand how reading is affected in people with dry eye in comparison with healthy controls and what effect reading has on the ocular surface in patients with dry eye.

Eligibility criteria: Inclusion Criteria:

* age of 50 or greater,
* literacy in English language,
* ability to give informed consent

Exclusion Criteria:

* binocular vision below 20/25,
* any ocular surgery within the last 3 months,
* mental issues,
* illiteracy,
* language problems which might possibly interfere with reading ability,
* history of taking or current use of topical prescription anti-inflammatory eye drops (including, cyclosporine and steroids as well as any glaucoma eye drops).

Primary outcomes:
measure: Sustained Silent Reading Speed
timeFrame: 30 minutes
Secondary outcomes:
measure: Change in Total Ocular Staining Score (OSS)
timeFrame: Before and after 30 minutes reading
measure: Change in Tear Osmolarity
timeFrame: Before and after 30 minutes reading
measure: Change in Visual Acuity
timeFrame: 30 minutes
measure: Cytokines
timeFrame: Tear samples were collected on the day of the exam. The samples were frozen to be assayed upon completion of the study.
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: The Wilmer Eye Institute, Johns Hopkins University
state: Maryland
Study officials:
affiliation: The Johns Hopkins University
name: Esen K Akpek, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00512512: Transoral Endoscopic Liver Biopsy During Laparoscopic Gastric Bypass
Official title: Transoral Endoscopic Liver Biopsy During Laparoscopic Gastric Bypass
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Steatohepatitis
Morbid Obesity
Keywords: transoral
transluminal
endoscopic
laparoscopic
liver
biopsy
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2007-08-07
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Morbid Obese patients who are already approved for gastric bypass surgery.

Brief summary: This research is being done to evaluate the ability to obtain a liver sample using upper endoscopy rather than through a laparoscopic procedure. The investigators hypothesize that the endoscopic transoral route is as effective as the laparoscopic route.


Eligibility criteria: Inclusion Criteria:

1. Any patient who meets criteria to undergo laparoscopic Roux-en Y Gastric Bypass (BMI\>40 or BMI\>35 with multiple medical co morbidities).
2. Age greater than 18 years.
3. Ability to complete all necessary components of study (gastric bypass surgery standard qualifications).

Exclusion Criteria:

1. Inability to give informed consent
2. Women who are pregnant or in whom pregnancy status cannot be confirmed.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Hopkins Bayview Medical Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Michael A Schweitzer, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Steele K, Schweitzer MA, Lyn-Sue J, Kantsevoy SV. Flexible transgastric peritoneoscopy and liver biopsy: a feasibility study in human beings (with videos). Gastrointest Endosc. 2008 Jul;68(1):61-6. doi: 10.1016/j.gie.2007.09.040. Epub 2008 Mar 4.
Clinical trial NCT01677312: Trial Comparing 19 and 25-gauge EUS-FNA Needles
Official title: Multi-Center Randomized Trial Comparing 19 and 25-gauge Needles for Endoscopic Ultrasound-guided Fine Needle Aspiration (EUS-FNA) of Solid Pancreatic Mass Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer of Pancreas
Pancreatic Neoplasm
Lead sponsor: AdventHealth
Sponsor class: OTHER
Collaborators: name: University of Alabama at Birmingham
First posted: 2012-09-03
Enrollment: 72
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study compares the 19G and 25G needles for procuring tissue samples from the pancreas during Endoscopic Ultrasound (EUS) procedures.

Detailed description: The study compares the median number of passes to establish a definitive diagnosis using the 19G or 25G needles. Also, the ability of both needles to procure a histological core tissue is assessed.

Eligibility criteria: INCLUSION CRITERIA:

(1) Patients with solid pancreatic mass lesions.

EXCLUSION CRITERIA:

1. Age \< 19 years
2. Unable to safely undergo EUS for any reason
3. Coagulopathy (INR \> 1.6, Prothrombin Time \> 18secs, Thrombocytopenia \< 80,000 cells/ml)
4. Unable to consent
5. Non-English speaking patients

Primary outcomes:
measure: Median Number of Passes to Establish Diagnosis
timeFrame: 5 months
Secondary outcomes:
measure: Procurement of Histological Samples
timeFrame: 30 days
measure: Needle Dysfunction
timeFrame: 2 hours
measure: Complications
timeFrame: 30 days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
Study officials:
affiliation: Florida Hospital Center for Interventional Endoscopy
name: shyam varadarajulu, MD
role: PRINCIPAL_INVESTIGATOR
References: