louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02049333: Cataract Surgery vs Cataract Surgery With ECPL for Treatment of Plateau Iris Configuration or Syndrome
Official title: Phacoemulsification Versus Phacoemulsification With Endoscopic Cycloplasty (ECPL) for Treatment of Plateau Iris Configuration or Syndrome: A Prospective Randomized Clinical and Surgical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Lead sponsor: Credit Valley EyeCare
Sponsor class: INDUSTRY
First posted: 2014-01-30
Enrollment: 26
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 assess and compare the mechanical angle opening in patients with angle closure due to a plateau iris configuration (elevated iris) using phacoemulsification combined with endoscopic cycloplasty versus treatment with phacoemulsification alone.


Eligibility criteria: Inclusion Criteria:

* Patient has to be ≥ 18 years of age of either gender
* Nuclear sclerotic cataract graded by LOCS III to be \< 5
* Diagnosis of Plateau Iris Configuration or Syndrome
* No contraindication for cataract or ECPL operation
* Written informed consent on IRB approved Informed Consent Form

Exclusion Criteria:

* Hard cataracts, LOCS III 5 and 6
* Ciliary body cysts
* Clinically significant sequelae from trauma in which angle anatomy/physiology may have been compromised (e.g., chemical burns, significant angle recession, blunt trauma, etc.)
* Congenital anomaly of the irido-trabecular angle
* Previous intraocular surgery
* Previous laser gonioplasty to either eye
* Placement of the intraocular lens in any place other than the capsular bag
* Pupilloplasty
* Rubeosis
* Peripheral anterior synechiae (PAS) nasal angle and/or \>180 degrees of PAS
* Neovascular glaucoma; or glaucoma associated with vascular ischemic disorders
* Active corneal inflammation or edema (e.g., keratitis, keratoconjunctivitis, keratouveitis)
* Corneal opacities or disorders that would inhibit visualization of the nasal angle
* Chronic ocular inflammatory disease or presence of active ocular inflammation with risk for synechial/proliferative changes
* Inability to attend regular follow-up assessment or to give informed written consent.

Primary outcomes:
measure: Anterior Chamber Angle Depth (nasal angle)
timeFrame: Twelve months
Secondary outcomes:
measure: Number of glaucoma medications
timeFrame: Twelve months post-op
measure: Intraocular pressure (IOP)
timeFrame: Twelve months post-op
Other outcomes:
measure: Intra- and post-operative complications
timeFrame: Up to one year after surgery
Locations:
city: Brampton
country: Canada
facility: Osler EyeCare
state: Ontario
city: Mississauga
country: Canada
facility: Credit Valley EyeCare
state: Ontario
Study officials:
affiliation: University of Toronto, Toronto, Canada
name: Ike K Ahmed, MD FRCSC
role: STUDY_DIRECTOR
References:
Clinical trial NCT02100033: How Acupuncture Sensation Propagated to Effect the Energy of Channels
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acupuncture Manipulation
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2014-03-31
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: De-qi as an important factor to therapeutic effect of acupuncture for years, It's a concrete pathway to approach Qi, an abstract concept in Chinese medicine. However, all previous physicians and medical scientists have different interpretation to De-qi, and no objective principles for clinical practice, teaching and studies.

Qi propagated combined with acupuncture practice always be seen as De-qi , therefore, the study control "transmission or not" and "direction of sensation propagated" to compare what's different in human body. If the change happened as prediction based on acupuncture theories, it could define De-qi for operation.

The study will collect 60 subjects, from age 20 to 40, the same numbers of male and female. They will accept different manipulation in left hand HeGu(LI4), and assessed the variations in microcirculation, temperature of left forearm, and waxing/waning of yin-yang , Qi and blood in related meridian. We hope to understand if sensation propagated is primary factor of De-Qi and acupuncture effect .


Eligibility criteria: Inclusion Criteria:

* both male and female
* age:20-40 years old

Exclusion Criteria:

* to be afraid of acupuncture
* easily fainting
* right index finger has been injured recent one month
* had taken drugs can trigger vasodilatation or vasoconstriction recent three months
* systemic diseases
* pregnancy

Primary outcomes:
measure: variation trend of electric conductivity
timeFrame: 30-60seconds per trial
Secondary outcomes:
measure: blood flow speed
timeFrame: 30-60seconds per trial
Other outcomes:
measure: EEG
timeFrame: 30-60seconds per trial
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
References:
Clinical trial NCT04893733: Intravenous Administration of Vitamin B Complex Improves Renal Recovery in Patients With AKI
Official title: The Use of Intravenous Vitamin B Complex Improves Renal Recovery in Patients With Acute Kidney Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Kidney Injury
Keywords: Acute Kidney Injury
Vitamin B complex
Creatinine
Proteinuria
Lead sponsor: Caja Nacional de Salud
Sponsor class: OTHER
Collaborators: name: International Society of Nephrology
First posted: 2021-05-19
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Animal and human studies have shown that the administration of vitamin B3 (niacin) improves renal ischemia; helping to recover from acute kidney injury (AKI) more effectively; Therefore, its use in patients with AKI could improve short-term outcomes: accelerating the recovery of renal function, reducing the days of hospital stay and costs; as well as reducing the incidence of chronic kidney disease (CKD) or progression of CKD after an episode of AKI.

Our main objective is to determine the usefulness of the administration of vitamin B complex as a treatment for established acute kidney injury and its effect on short and long-term outcomes.


Eligibility criteria: Inclusion Criteria:

* Patients over 18 years of age who meet modified KDIGO criteria for Acute Kidney Injury, based on serum creatinine or urinary volume criteria.

Exclusion Criteria:

* Patient under 18 years of age
* Patients with stage G5 chronic kidney disease
* Patients with chronic kidney replacement therapy.
* Pregnant women
* Transplant patients

Primary outcomes:
measure: Complete renal recovery
timeFrame: Day 7
Secondary outcomes:
measure: Progression to Acute Kidney Disease (AKD)
timeFrame: 1 month
measure: De novo chronic kidney disease (CKD)
timeFrame: 3 months
measure: Progression of CKD
timeFrame: 3 months
Other outcomes:
Locations:
city: Cochabamba
country: Bolivia
facility: Hospital Obrero No 2 - C.N.S.
Study officials:
affiliation: Hospital Obrero No 2 - C.N.S.
name: Rolando Claure-Del Granado, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02825433: Observing Changes in Ventilation Pattern During Procedural Sedation
Official title: Observing Changes in Ventilation Pattern During Procedural Sedation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Ventilation
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2016-07-07
Enrollment: 160
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: Patients receiving procedural sedation for endoscopy

Brief summary: The ventilation (respiratory rate, tidal volume and end-tidal CO2) was monitored for patients receiving procedural sedation during endoscopy procedures in order to observe what changes commonly occur.

Detailed description: The literature does not currently describe which ventilation changes a clinician should watch for to keep a patient safe during procedural sedation provided by fentanyl and propofol. This observational study aimed to record the breath-by-breath respiratory rate, tidal volume and end-tidal CO2 for each patient during procedural sedation for each endoscopy procedure. Data analysis offline will aim to identify any patterns in ventilation which may precede apnea or blood oxygen desaturation. The patterns in ventilation preceding apnea or blood oxygen saturation will be compared and contrasted with the patterns of ventilation during normal ventilation periods.

Eligibility criteria: Inclusion Criteria:

* (i) ASA I, II, or III
* (ii) patients older than eighteen
* (iii) English speaking
* (iv) undergoing a colonoscopy procedure and receiving procedural sedation

Exclusion Criteria:

* (i) inability/refusal of subject to provide informed consent
* (ii) standard colonoscopy exclusion criteria used at the GI lab at the University of Utah
* (iii) patients with severe medical conditions that in the view of the acting physician prohibits participation in the study

Primary outcomes:
measure: Respiratory rate
timeFrame: Measured for every breath observed throughout the endoscopy procedure
measure: Tidal volume
timeFrame: Measured for every breath observed throughout the endoscopy procedure
measure: End-tidal CO2
timeFrame: Measured for every breath observed throughout the endoscopy procedure
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00801333: Derivation of Induced Pluripotent Stem Cells From an Existing Collection of Human Somatic Cells
Official title: Derivation of Induced Pluripotent Stem Cells From an Existing Collection of Human Somatic Cells
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Amyotrophic Lateral Sclerosis
Keywords: ALS
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2008-12-03
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We will use human somatic cells from existing collections.

Brief summary: Induced pluripotent stem cells potentially may be useful in the future as an unlimited source of cells for transplantation.

The major goal of the project is to develop human iPS cells from various types of cell cultures or lines from existing collections. The IPS cells will be developed for modeling diseases, for developing the technology that may eventually allow the use of IPS cells for transplantation therapy, and for basic research.

Detailed description: The potential to reprogram somatic cells into an embryonic state raises multiple basic research questions related both to the process of reprogramming and the properties of iPS cells. We will use various approaches to study the molecular mechanisms and processes that occur during reprogramming. We will use various experimental systems to characterize and study the properties of the iPS cells, their biology, developmental potential, capability to give rise to functional differentiated progeny etc.

We will induce the differentiation of the iPS cells towards specific cell lineages and the progeny can be used to study the pathogenesis of diseases. They will be used for developing new therapeutic approaches and for high throughput screening of factors for potential toxic or therapeutic effects.

All samples will be non-identified.

Eligibility criteria: Inclusion Criteria:

* Volunteers
* Male and Female

Exclusion Criteria:

* Below the official age of consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization - Ein Kerem Campus
city: Jerusalem
country: Israel
facility: Hadassah Ein Kerem
Study officials:
affiliation: Chairman of Department of Obstetrics & Gynecology/IVF, Hadassah Ein Kerem
name: Benjamin E Reubinoff, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dimos JT, Rodolfa KT, Niakan KK, Weisenthal LM, Mitsumoto H, Chung W, Croft GF, Saphier G, Leibel R, Goland R, Wichterle H, Henderson CE, Eggan K. Induced pluripotent stem cells generated from patients with ALS can be differentiated into motor neurons. Science. 2008 Aug 29;321(5893):1218-21. doi: 10.1126/science.1158799. Epub 2008 Jul 31.
Clinical trial NCT01067833: Phase 2 Study of Oral K201 for Prevention of AF Recurrence
Official title: A Pilot Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Centered Safety, Tolerability and Preliminary EffiCacy Study of K201 Oral for the Prevention of ATrial FIbrillation (AF) Recurrence in Subjects Post-Conversion From AF
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation
AF
Lead sponsor: Sequel Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2010-02-12
Enrollment: 300
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: To evaluate the safety, efficacy, and tolerability of 3 doses of K201 (oral) administered for up to 28 days in subjects with recent DC cardioversion to sinus rhythm from sustained symptomatic atrial fibrillation (AF duration \>3 days and \<6 months).


Eligibility criteria: Inclusion Criteria:

* Symptomatic AF (sustained \>3 days and \<6 months) and clinically indicated for cardioversion;
* Adequate anticoagulant therapy for cardioversion in accordance with standard practice as recommended by ACC/AHA/ESC guidelines or with local clinical practice;
* Hemodynamically stable (90 mmHg \< systolic blood pressure \< 190 mmHg)at screening and on Day 1;

Exclusion Criteria:

* Known prolonged QT syndrome or QTc interval of \>0.500 sec at screening; familial long QT syndrome; previous Torsade de Pointes; ventricular fibrillation; or sustained ventricular tachycardia (VT);
* QRS \>0.130 sec;
* Previous episodes of second- or third-degree atrioventricular block;
* Unsuccessful DC cardioversion attempt within 3 months; prior ablation for AF;
* Persistent bradycardia with ventricular rate below 50 beats/min, sick-sinus syndrome or pacemaker (including CRT, AICD);
* Myocardial infarction (MI), cardiac surgery, angioplasty, unstable angina or acute coronary syndrome within 30 days prior to entry into the study;
* NYHA Class III or Class IV heart failure (HF) at screening or admission, or hospitalized for HF in previous 6 months;
* Known concurrent temporary secondary causes of AF;
* Received a Class I or Class III antiarrhythmic agent (including sotalol) within 5 half-lives of randomization or amiodarone or dronedarone within 4 weeks;
* Received treatment with other drugs known to prolong the QT interval within 5 half-lives.

Primary outcomes:
measure: time to first documented recurrence of symptomatic AF
timeFrame: 28 days
measure: time to first documented recurrence of symptomatic or asymptomatic AF
timeFrame: 28 days
measure: proportion of subjects in sinus rhythm
timeFrame: Day 28
measure: number of AF beats
timeFrame: 10 days
measure: time in AF
timeFrame: 10 days
measure: safety assessments: vital signs, laboratory assays, ECG parameters, physical exams, frequency of adverse events
timeFrame: 42 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Sequel Pharmaceuticals
name: Paul Chamberlin, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04450433: Functional Study of Metabolites in Patients With Aortic Dissection
Official title: Functional Study of Metabolites in Patients With Aortic Dissection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aortic Dissection
Lead sponsor: Shenzhen People's Hospital
Sponsor class: OTHER
First posted: 2020-06-29
Enrollment: 1
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 30 patients with aortic dissection and 15 healthy people

Brief summary: Research on metabolites in patients with aortic dissection, with a view to finding products with high or low metabolism in patients with aortic dissection, looking for metabolic factors related to the onset of aortic dissection, and further verifying the role of metabolic factors in disease through functional verification The role of formation, and ultimately explore the early screening of potential aortic dissection patients


Eligibility criteria: Inclusion Criteria:

* patients with Aortic dissection

Exclusion Criteria:

* Sepsis

Primary outcomes:
measure: Differential expression of metabolites in two groups of patients
timeFrame: 2019-11----2021.01
Secondary outcomes:
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Shenzhen People's Hospital
state: Guangdong
Study officials:
References:
Clinical trial NCT00806533: Non-Interventional (Observational) Post-Authorization Safety Study of HES 130/0.42 in Paediatric Patients
Official title: Infusion of Venofundin 6% or Tetraspan 6% in Paediatric Patients Aged up to 12 Years
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery
Lead sponsor: B. Braun Melsungen AG
Sponsor class: INDUSTRY
First posted: 2008-12-11
Enrollment: 1130
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: paediatric patients aged up to 12 years

Brief summary: This observational (non-interventional) post-authorization safety study (PASS) will investigate the application of Venofundin 6% and of Tetraspan 6% in children with special regard to drug safety.


Eligibility criteria: Inclusion Criteria:

* Age ≤12 years
* Risk of anaesthesia: American Society of Anaesthesiologists (ASA) risk score: I - III
* infusion of Venofundin 6% or of Tetraspan 6%
* elective intervention

Exclusion Criteria:

* contraindications according to SmPC

Primary outcomes:
measure: incidence of adverse events
timeFrame: peri-operative
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Donauspital SMZ-OST
city: Brno
country: Czech Republic
facility: Clinic of Children's Anaesthesiology and Resuscitation
city: Praha
country: Czech Republic
facility: Clinic of Anaesthesiology and Resuscitation
city: Dresden
country: Germany
facility: Klinik für Anästhesiologie und Intensivmedizin, TU Universität Dresden
city: Hannover
country: Germany
facility: Klinik für Anästhesiologie und Intensivmedizin, Medizinische Hochschule Hannover
city: Mannheim
country: Germany
facility: Klinikum Mannheim
city: Stuttgart
country: Germany
facility: Olgahospital
city: Bologna
country: Italy
facility: S. Orsola Hospital, University hospital
city: Amsterdam
country: Netherlands
facility: Academic Mesich Centrum (AMC)
city: Rotterdam
country: Netherlands
facility: Erasmus MC, Univesity Medical Center Rotterdam, Sophias's Children's Hospital (SKZ)
Study officials:
affiliation: MHH Hannover
name: R. Suempelmann, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sumpelmann R, Kretz FJ, Gabler R, Luntzer R, Baroncini S, Osterkorn D, Haeger MC, Osthaus WA. Hydroxyethyl starch 130/0.42/6:1 for perioperative plasma volume replacement in children: preliminary results of a European Prospective Multicenter Observational Postauthorization Safety Study (PASS). Paediatr Anaesth. 2008 Oct;18(10):929-33. doi: 10.1111/j.1460-9592.2008.02696.x. Epub 2008 Jul 21.
Clinical trial NCT05469633: Application of Portable Ultrasonic Evaluation of Gastric Contents in Painless Gastroscopy
Official title: Application of Portable Ultrasonic Evaluation of Gastric Contents in Painless Gastroscopy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ultrasound Evaluation of Gastric Contents
Keywords: gastric ultrasound
gastric contents
painless electronic gastroscope
Lead sponsor: The Second Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2022-07-22
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Outpatients undergoing painless electronic gastroscopy were fasted for 8 hours in acccordance with gastroscopy guidelines

Brief summary: To explore the correlation between gastric ultrasound evaluation and gastroscopic direct vision evaluation of gastric contents, so as to more accurately use gastric ultrasound to evaluate the gastric contents of patients undergoing painless electronic gastroscopy in the outpatient department, so as to develop an individual painless diagnosis and treatment strategy to reduce the risk of lung aspiration.


Eligibility criteria: Inclusion Criteria:

* ≥18years
* Patients undergoing painless electronic gastroscopy.
* Voluntarily participate and sign informed consent.

Exclusion Criteria:

* Patients undergoing general electronic gastroscopy.
* Patients who refused to undergo gastric ultrasound.
* Patients with postural difficulties during gastric ultrasonography.
* with fresh wounds or infections at the site of Gastric ultrasound
* Patients whose ultrsound image quality is too poor to properly display the relevant anatomical structures.

Primary outcomes:
measure: The cross-sectional area of the antrum (CSA)
timeFrame: Before the painless electronic gastroscopy
measure: Predicted volume
timeFrame: Before the painless electronic gastroscopy
measure: Observed volume
timeFrame: Before the painless electronic gastroscopy
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The Second Affiliated Hospital, Chongqing Medical University
state: Chongqing
Study officials:
affiliation: Department of Anesthesiology,The Second Affiliated Hospital ,Chongqing Medical University
name: Chen Yupei
role: STUDY_DIRECTOR
References: