louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05401825: Antenatal COVID 19 Vaccination and Pregnancy Outcomes
Official title: Antenatal COVID 19 VACCINATION and Pregnancy Outcomes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Effect of Drug
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-06-02
Enrollment: 162
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: pregnant women aged 18 years or older who received any type of COVID 19 vaccine during current pregnancy

Brief summary: Effect of COVID 19 vaccinations on pregnancy outcomes must be clear and identified to detect their safty

Detailed description: in this study we will discuss side effects of COVID 19 vaccine on pregnant women including the incidence of miscarrage , intrauterine fetal deaths, liquor abnormalities, preeclampsia, accidental hemorrhage , we also will follow up pregnant women who received any type of COVID 19 vaccine till delivery and discuss the effect of the vaccine on fetus and newborn

Eligibility criteria: Inclusion Criteria:

* pregnant women aged 18 years or older who received any type of COVID 19 vaccine during current pregnancy

Exclusion Criteria:

* comorbidities,women who refused participqtion,pregnant women with previous COVID 19 infection during current pregnancy

Primary outcomes:
measure: pregnancy loss
timeFrame: in first, second, third trimester
Secondary outcomes:
measure: fetal malformations
timeFrame: at each trimester
measure: pregnancy related hypertensive disorders
timeFrame: starting from 20 weeks of gestation
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ainshams university
Study officials:
affiliation: Ainshams university
name: Ahmed M Mamdouh, assistant professor
role: STUDY_DIRECTOR
affiliation: Ainshams university
name: Walid H Eltantawy, professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05244525: Subacromial Injection of Epinephrine Improves Visualization in Shoulder Arthroscopy
Official title: Subacromial Injection of Epinephrine Improves Visualization in Shoulder Arthroscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Shoulder Arthroscopy
Keywords: Shoulder
Rotator Cuff
Epinephrine
Subacromial bursa
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2022-02-17
Enrollment: 60
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 surgeon-rated visual clarity and the need for increased irrigation pump pressure during arthroscopic shoulder surgery and to evaluate mean arterial pressure, operative time, and any adverse events that occur during arthroscopic shoulder surgery.


Eligibility criteria: Inclusion Criteria:

* Undergo arthroscopic shoulder surgery in the seated upright (beach-chair) position requiring visualization within the subacromial space

Exclusion Criteria:

* Are unable to provide informed consent
* Non-English speaker
* Have a history of adverse medication reaction to epinephrine

Primary outcomes:
measure: Surgeon-rated Visual Clarity as Assessed by the Visual Analog Scale
timeFrame: end of surgery(about 30-120 minutes from start of surgery)
measure: Percentage of Participants for Whom Intra-operative Arthroscopic Pump Pressure Was Increased to 45mmHg or Higher During the Surgical Procedure
timeFrame: From start of surgery to end of surgery(about 30-120 minutes)
Secondary outcomes:
measure: Intraoperative Mean Arterial Pressure
timeFrame: end of surgery(about 30-120 minutes from start of surgery)
measure: Total Operative Time
timeFrame: end of surgery(about 30-120 minutes from start of surgery)
measure: Number of Subjects Who Experience Intraoperative Adverse Events
timeFrame: end of surgery(about 30-120 minutes from start of surgery)
measure: Number of Subjects Who Experience Post Operative Adverse Events
timeFrame: from the end of surgery up to 2 weeks post surgery
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: James M Gregory, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02160925: Study of 99mTc-Sestamibi SPECT/CT Imaging for the Preoperative Diagnosis of Renal Oncocytoma
Official title: Study of 99mTc-Sestamibi SPECT/CT Imaging for the Preoperative Diagnosis of Renal Oncocytoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Clinical T1 Renal Mass
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2014-06-11
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The objective of this study is to investigate the utility of 99mTc-sestamibi SPECT/CT imaging for the diagnosis of renal oncocytomas.


Eligibility criteria: Inclusion Criteria:

* Presence of a solid enhancing cT1 renal mass detected on cross-sectional imaging
* Scheduled to undergo surgery with either partial or radical nephrectomy
* Age ≥18 years

Exclusion Criteria:

* Pregnancy
* Evidence of nodal or distant metastases
* History of other malignancy with concern for renal metastasis
* Known allergy to technetium or sestamibi

Primary outcomes:
measure: Correlation of preoperative 99mTc-sestamibi SPECT/CT findings with tumor histology following surgical resection.
timeFrame: Within 2 weeks of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Mohamad Allaf, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01842425: Changes in Body- and Liver-composition During Low Calorie Diet in Morbidly Obese
Official title: Changes in Body- and Liver-composition During Low Calorie Diet in Morbidly Obese
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obesity
Keywords: Liver volume
Gastric bypass
Magnetic resonance imaging
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2013-04-29
Enrollment: 30
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Morbidly obese females awaiting laparoscopic gastric bypass surgery

Brief summary: The purpose of this study is to determine what changes occur in body- and liver-composition during four weeks of low calorie diet in morbidly obese females

Detailed description: Preoperative weight loss prior to laparoscopic gastric bypass is desirable as this reduces liver volume and thus facilitates the visualization of the gastro-esophageal junction. Weight loss is often achieved through low-calorie diet (LCD); however the ideal duration of LCD treatment is unknown.

Morbidly obese female patients awaiting laparoscopic gastric bypass are recruited. They are, as all our patients, treated during four weeks with LCD to achieve a decrease in liver size. During this period they are examined on day 0, 3, 7, 14 and 28 after commencing LCD.

At each evaluation, body composition is assessed through bioelectric impedance analysis (BIA), liver volume and intrahepatic fat through magnetic resonance imaging. A questionnaire regarding quality of life and LCD-related symptoms is administered as well. At surgery two samples of subcutaneous fat and one sample of omental fat is taken.

We do not assign patients to different treatments, instead all are treated similarly according to our routine preoperative regimen.

Eligibility criteria: Inclusion Criteria:

* Awaiting laparoscopic gastric bypass
* Residing near Uppsala

Exclusion Criteria:

* Weight above 140 kg
* Metal implants such as pacemaker or intracerebral clips
* Failure to understand or comply with study protocol

Primary outcomes:
measure: Liver volume
timeFrame: From baseline to after four weeks
Secondary outcomes:
measure: Composition of body fat in subcutaneous and omental fat
timeFrame: At surgery
measure: Changes in body composition
timeFrame: Baseline to 4 weeks
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Department of surgery, Akademiska sjukhuset
Study officials:
affiliation: Department of Surgery
name: David Edholm, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05894525: Post-Marketing Safety Study in Japan in Participants With High Risk of Severe Exacerbation of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) mRNA-1273 COVID-19 Vaccine
Official title: Cohort Survey on Acute Phase Safety in Persons With Underlying Diseases Considered to Be at High Risk of Severe COVID-19 by Using Vaccination Information
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS-CoV-2
Keywords: mRNA-1273
mRNA-1273 vaccine
SARS-CoV-2
SARS-CoV-2 Vaccine
Coronavirus
Virus Diseases
Messenger RNA
COVID-19
COVID-19 Vaccine
Moderna
Lead sponsor: ModernaTX, Inc.
Sponsor class: INDUSTRY
First posted: 2023-06-08
Enrollment: 8844
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population was selected from participants who were registered to receive the mRNA-1273 vaccine in the Pep Up vaccination history Database and those who met the definition of underlying disease based on the claim data for 6 months from August 2020 to November 2021.

Brief summary: The goal of this study is to assess the adverse events in the acute phase observed after vaccination with the mRNA-1273 vaccine in persons with underlying diseases who are considered to have a high risk of severe exacerbation specified in COVID-19.

Detailed description: Data collected from the JDMC Claims Database between August 2020 to November 2021.

Eligibility criteria: Inclusion Criteria:

* Participants registered to receive the mRNA-1273 vaccine in the Pep Up vaccination history Database
* Participants who have a history of vaccination with the mRNA-1273 vaccine in the Pep-Up vaccination history Database and have underlying diseases. Data period for confirmation of presence/absence of underlying disease is August 2020 to November 2021.

Exclusion Criteria:

* Underlying diseases that were determined undetectable by the pre-screening of JMDC
* Participants who did not consent to the questionnaire

Primary outcomes:
measure: Number of Participants With Solicited Acute Adverse Events
timeFrame: Up to 8 days post vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: CMIC Co. Ltd.,
Study officials:
References:
Clinical trial NCT02961725: Stem Cells for Treatment of Bronchopleural Fistula
Official title: Umbilical Cord Mesenchymal Stem Cells for Treatment of Bronchopleural Fistula
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Bronchopleural Fistula
Lead sponsor: The Second Affiliated Hospital of Fujian Medical University
Sponsor class: OTHER
Collaborators: name: Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
First posted: 2016-11-11
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Bronchopleural fistula (BF), an abnormal passage or communication between a bronchus and another part of the body, may develop when there are penetrating wounds of the thorax and after lung surgery. Without effective therapy, treatment of BF is a challenge, with a high rate of mortality and teratogenicity.

The investigators will conduct endoscopic injection of umbilical cord mesenchymal stem cells to fistula, observe the recovery of bronchopleural fistula and systemic reactions, to investigate the application of umbilical cord mesenchymal stem cells in the treatment of bronchopleural fistula.


Eligibility criteria: Inclusion Criteria:

* diagnosed with bronchopleural fistula by imaging or bronchoscopic examination
* typical symptom of bronchopleural fistula, such as fever, cough, purulent sputum, weight loss...
* patients present compromised conditions, who can only accept a conservative treatment.

Exclusion Criteria:

* absolute contraindication of bronchoscopic examination and treatment
* with previous treatment of cell therapy, including stem cells.

Primary outcomes:
measure: closure of the fistula
timeFrame: 24 weeks
Secondary outcomes:
measure: complication
timeFrame: 1 year
Other outcomes:
Locations:
city: Quanzhou
country: China
facility: The Second Affiliated Hospital of Fujian Medical University
state: Fujian
Study officials:
affiliation: The Second Affiliated Hospital of Fujian Medical University
name: Yimin Zeng, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01991925: Implications for Quality of Life and Quality of Care in Patients With Hereditary Haemochromatosis
Official title: Implications for Quality of Life and Quality of Care in Patients With Hereditary Haemochromatosis
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Hereditary Haemochromatosis
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2013-11-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Phase 1: RAND-modified Delphi Method: experts in the field of hereditary haemochromatosis Phase 2: Patients with hereditary haemochromatosis

Brief summary: Patients with hereditary haemochromatosis will be interviewed/questioned about their Quality of life and the delivered quality of care in the hospital.

Detailed description: Patients with hereditary haemochromatosis will be interviewed/questioned about their Quality of life and the delivered quality of care in the hospital during follow-up

Eligibility criteria: Inclusion Criteria:

* phase 1: experts in the field of haemochromatosis (hepatologists, hematologists, endocrinologists, general practitioner, nurses, ...)
* phase 2: patients with hereditary haemochromatosis, treatment with phlebotomy since 3 months, Dutch/English speaking

Exclusion Criteria:

* patients with secondary iron overload
* phlebotomy treatment less than 3 months
* language: no Dutch or English

Primary outcomes:
measure: evaluation of quality of life
timeFrame: after 3 months of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
state: Vlaams-brabant
Study officials:
affiliation: UZ Leuven
name: Annick Vanclooster
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00698425: Safety and Tolerability Study of Transscleral Iontophoresis by the EyeGate® II Drug Delivery Device System
Official title: Single Center, Single-masked, Randomized, Dose Escalation Study to Evaluate Safety and Tolerability of Transscleral Iontophoresis Using Citrate Buffer Delivered by the EyeGate® II Drug Delivery Device System in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Iontophoresis
Ophthalmology
Lead sponsor: Eyegate Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2008-06-17
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and tolerability of a single iontophoretic dose of buffered solution administered through the EyeGate® II Drug Delivery System in healthy adult human volunteers.

Detailed description: This is a single center, randomized, single-masked, comparative group, safety and tolerability study of single dose levels of citrate buffer delivered through transcleral iontophoresis administered via the EyeGate® II Drug Delivery System. The current study will also determine the safety and tolerability of the dose ranges of transcleral iontophoresis from 2 mA through 7 mA and will determine the safety and tolerability of the application of the Eyegate II system on the eye for time ranges of up to 10.5 minutes.

Eligibility criteria: Inclusion Criteria:

* Healthy adults
* Normal ophthalmic examination in both eyes

Exclusion Criteria:

* Presence of subjective ocular symptoms
* Presence of conjunctival hyperemia, chemosis, watering, conjunctival discharge
* Ocular trauma

Primary outcomes:
measure: Safety assessed through patient reported adverse events
timeFrame: Prospective
Secondary outcomes:
measure: Ophthalmic examinations
timeFrame: Prospective
measure: Ocular discomfort on a visual analog scale (VAS)
timeFrame: Prospective
Other outcomes:
Locations:
city: Bangalore
country: India
facility: St. John's Medical College Hospital
state: Karnataka
Study officials:
affiliation: St Johns Medical College Hospital, Bangalore, India
name: Manjoo Reddy, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01254825: The Efficacy of Adductor-Canal-Block (ACB) in Patients After Knee Arthroscopy
Official title: The Efficacy of Adductor-Canal-Block (ACB) in Patients After Knee Arthroscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Meniscus Lesion
Pain (Knee)
Diagnostic Knee Artroscopy
Minor Knee Surgery
Keywords: Adductor Canal Block (ACB)
Diagnostic Knee Arthroscopy
Saphenous nerve
Pain
Ultrasound block
Lead sponsor: Glostrup University Hospital, Copenhagen
Sponsor class: OTHER
First posted: 2010-12-07
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Purpose of this study is to determine whether Adductor-Canal-Block (ACB) is superior to placebo when it comes to analgetic efficacy after Knee-Arthroscopy.


Eligibility criteria: Inclusion Criteria:

* 18-80 years
* Knee-arthroscopy
* Written consent
* ASA I-III
* BMI 19-35

Exclusion Criteria:

* Unable to communicate in Danish
* Allergic reactions toward drugs used in the trial
* Pregnancy
* Abuse of alcohol/drugs
* Daily opioid intake
* Infection at injection site
* Can not be mobilised to 5 meters of walk; pre-surgery

Primary outcomes:
measure: Pain-Score (VAS) - patient standing
timeFrame: 2 hours postoperative
Secondary outcomes:
measure: Pain-score (VAS), patient at rest
timeFrame: 0,1,2,4,6,8,24 hours postoperative
measure: Pain-score (VAS), patient standing
timeFrame: 1,2,4,6,8,24 hours postoperative
measure: Pain-score (VAS), after 5 meters of walk
timeFrame: 2,4,6,8,24 hours postoperative
measure: Total Opioid-consumption
timeFrame: 0-24 hours postoperative
measure: Opioid-consumption, postoperative
timeFrame: 0-2, 2-4, 4-6, 6-8, 8-24 hours postoperative
measure: Postoperative Nausea and vomiting
timeFrame: 0-1, 1-2, 2-4, 4-6, 6-8, 8-24 hours postoperative
measure: Postoperative ondansetron consumption
timeFrame: In-hospital
measure: Sedation
timeFrame: 0,1,2,4,6,8,24 hours postoperative
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Department of Anaesthesiology, Glostrup University Hospital
state: Copenhagen
Study officials:
affiliation: Glostrup University Hospital, Copenhagen, Denmark
name: Malene Espelund, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Espelund M, Fomsgaard JS, Haraszuk J, Dahl JB, Mathiesen O. The efficacy of adductor canal blockade after minor arthroscopic knee surgery--a randomised controlled trial. Acta Anaesthesiol Scand. 2014 Mar;58(3):273-80. doi: 10.1111/aas.12224. Epub 2013 Nov 8.
Clinical trial NCT04038125: Increase in Capillary Plexus Density Level Following the Use of Ozurdex for the Treatment of DME
Official title: Increase in Capillary Plexus Density Level Following the Use of Ozurdex for the Treatment of DME (RMSM ICOD STUDY)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Diabetic Macular Edema
Diabetic Retinopathy
Retinal Ischemia
Keywords: Diabetic Macula Edema
Diabetic Retinopathy
Retina Ischemia
Lead sponsor: Retina Macula Specialists of Miami, LLC
Sponsor class: OTHER
Collaborators: name: Allergan
First posted: 2019-07-30
Enrollment: 20
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 objective of this study is to test the hypothesis that following the use of intravitreal dexamethasone implant for the treatment of DME, there will be an observable increase in the capillary density plexus as denoted by the quantitative assessment of the superficial capillary plexus on OCTA, as well as a decrease in size of the foveal avascular zone (FAZ).


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years and Older.
2. Diagnosis of diabetes mellitus (type 1 or type 2).
3. At least one eye meets the study eye criteria listed.
4. Visual Acuity 20/30 - 20/200 Snellen equivalent
5. Have received no previous treatment for diabetic macular edema,(treatment naïve)
6. Mild to Severe Non-proliferative Diabetic Retinopathy
7. Diabetic macular edema present on optical coherence tomography (OCT) central subfield: ≥ 300µm.
8. Able and willing to provide informed consent.

Exclusion Criteria:

1. Have had any prior ocular treatment.
2. Have had prior retinal surgical ( i.e. Pars plana vitrectomy). 3 .Have any clinical evidence of proliferative diabetic retinopathy.

4. Have a HBA1c of greater of 10%. 5. Evidence of Glaucoma or who are labeled glaucoma suspect at screening (defined as C/D \>/= 0.5 with correlated NFLA thinning or IOP\>25mmHg). 6. Have a contraindication to Ozurdex.

Primary outcomes:
measure: Evaluate re perfusion following Ozurdex use.
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: North Miami Beach
country: United States
facility: Retina Macula Specialists of Miami, LLC
state: Florida
city: South Miami
country: United States
facility: Retina Macula Specialists of Miami, LLC
state: Florida
Study officials:
affiliation: Retina Macula Specialists of Miami, LLC
name: Diana Shechtman, OD FAAO
role: PRINCIPAL_INVESTIGATOR
References: