louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01849614: Assessment of Ability of Breath Hold for Left-sided Breast Cancer Radiation Therapy to Reduce Side Effects to Heart
Official title: Prospective Pilot Study of Assessment of Breath Hold as a Means to Mitigate the Risk of Radiation-associated Reductions in Regional Cardiac Perfusion in Patients With Left-sided Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2013-05-08
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with left-sided breast cancer

Brief summary: The purpose of this research study is to demonstrate that Deep Inspiration Breath Hold (DIBH), the technique used at the University of North Carolina (UNC) for left-side breast cancer radiation therapy, can reduce side effects to the heart.

Detailed description: The primary objective of this study is to estimate the rate of radiation-associated regional myocardial perfusion defects in patients 6 months after breast/chestwall radiation with DIBH for left-sided breast cancer. Cardiac perfusion will be assessed using SPECT cardiac perfusion scans pre- and 6 months post-radiation.

Eligibility criteria: Inclusion Criteria:

* signed an Institutional Review Board (IRB)-approved informed consent document for protocol
* age \>= 18 years
* histologically confirmed left-sided breast cancer scheduled to undergo curative intent radiation treatment post lumpectomy or mastectomy
* stage 0-III left-sided breast cancer (including DCIS)
* SPECT score of 0 at baseline
* radiation oncologist agrees target volume coverage will not be compromised via use of the DIBH technique along with conformal field shaping

Exclusion Criteria:

* active cardiac disease, defined as a history of angina, arrhythmias, myocardial infarction, congestive heart failure, or any other cardiac condition, which in the opinion of the treating physician would make this protocol unreasonably hazardous for the patient
* symptomatic pulmonary disease currently requiring regular medication including but not restricted to bronchodilators
* concurrent chemotherapy
* prior receipt of mediastinal radiation therapy
* pregnant or lactating women
* inability to understand and follow breathing instructions for the DIBH procedure

Primary outcomes:
measure: Changes in cardiac perfusion
timeFrame: 6-months post radiation
Secondary outcomes:
measure: Wall-motion abnormalities
timeFrame: 6-months post-treatment
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill, Department of Radiation Oncology
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Timothy M Zagar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03394014: Ultrasound-guided Sciatic Nerve Block in Below Knee Amputation Surgery
Official title: Ultrasound -Guided Sciatic Nerve Block in Below Knee Amputation Surgery: Subgluteal Versus Popliteal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sciatic Nerve Block
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2018-01-09
Enrollment: 56
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 56 ASA physical status II and III patients, aged 45-75 year, undergoing elective below knee amputation were randomly assigned to receive either sciatic nerve block using a popliteal approach or a sub gluteal approach. Patients in both groups received same amount of LA and additional ultrasound guided femoral nerve block to ensure sensory block of the medial side of the leg. Success of the block was considered when the block is solid and doesn't require shifting to GA

Detailed description: 56 ASA physical status II and III patients, aged 45-75 year, undergoing elective below knee amputation were randomly assigned to receive either sciatic nerve block using a popliteal approach (group P, n 28) or a sub gluteal approach (group G, n 28). Patients in both groups received same amount of LA (25 ml of bupivacaine 0.5 %) and additional ultrasound guided femoral nerve block by 10 ml of bupivacaine 0.5% to ensure sensory block of the medial side of the leg. Time to complete sensory and motor block, time taken to perform the block, block-related complications, block duration, time for asking for rescue analgesia in the first 24 h were recorded and both patients and surgeons were asked about their level of satisfaction. Success of the block was considered when the block is solid and doesn't require shifting to GA

Eligibility criteria: Inclusion Criteria:

* ASA physical status II and III patients
* aged 45-75 years,
* undergoing elective below knee amputation

Exclusion Criteria:

* patients who refused to participate in the study,
* those having allergy to local anaesthetics,
* or having contraindications to regional anaesthesia (having neurologic or neuromuscular disease, on anticoagulation therapy, or having skin infection at the site of needle insertion).

Primary outcomes:
measure: to compare between the two techniques as regards the success rate.
timeFrame: 24 hours
Secondary outcomes:
measure: time taken to perform the block
timeFrame: 10-20 min
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00621114: Ex Vivo Microbiological Assessment of an Anti-biofilm Catheter in Acute Dialysis Application
Official title: Ex Vivo Microbiological Assessment of an Anti-biofilm Catheter in Acute Dialysis Application
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodialysis
Keywords: Dialysis, Extracorporeal
Dialysis, Renal
Extracorporeal Dialysis
Hemodialysis
Lead sponsor: Vantive Health LLC
Sponsor class: INDUSTRY
Collaborators: name: Gambro Dialysatoren GmbH
name: Baxter Healthcare Corporation
First posted: 2008-02-22
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The clinical study aims at providing data on antimicrobial efficiency and a supposed additional preventive effect on catheter-related infections of a catheter with antibacterial surface coating in comparison to standard catheters without coating.

Detailed description: Central venous catheters are increasingly used to provide long-term venous access, e.g. after failure of the primary arteriovenous fistula, and they are the first choice in case of an acute need for extracorporeal therapy. Microbial adhesions and biofilm formation have been implicated in serious infections associated with the use of indwelling catheters.

In view of the necessity to reduce catheter-related bloodstream infections and of the inadequacy of currently available antimicrobially coated devices, a new antimicrobial catheter surface was developed.

The clinical study described below aims at providing further data on antimicrobial efficiency and a supposed additional preventive effect on catheter-related infections.

Eligibility criteria: Inclusion Criteria:

* central venous catheter placement
* Need for extracorporeal renal replacement therapy (acute and chronic renal failure)
* Anticipated duration of dialysis therapy less than or equal to 30 days
* Age between 18 and 85 years
* Written informed consent

Exclusion Criteria:

* Known Hepatitis B Virus (HBV)/Hepatitis C Virus (HCV)/Human Immunodeficiency Virus (HIV) infection
* Known pregnancy

Primary outcomes:
measure: Bacterial colonisation of the catheter surface
timeFrame: after explantation
Secondary outcomes:
measure: venous and arterial pressure
timeFrame: during dialysis
measure: catheter dwell time
timeFrame: at explantation
measure: exit site appearance
timeFrame: at routine catheter care
measure: blood parameters
timeFrame: during dialysis
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: Universitaetsklinikum Tuebingen
Study officials:
affiliation: Universitaetsklinikum Tuebingen
name: Teut Risler, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02517814: Vitamin D Supplementation Can Improve Heart Function in Idiopathic Cardiomyopathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiomyopathy, Dilated
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2015-08-07
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Vitamin D deficiency could be a high risk for cardiovascular diseases. It has been recently reported that vitamin D deficiency is another cause of heart failure and cardiomyopathies. It was found that vitamin D supplementation improved the heart function. The purpose of this study is to evaluate patients with idiopathic cardiomyopathies and determine whether vitamin D supplementation in cases where there is a deficiency, improves heart functioning.


Eligibility criteria: Inclusion Criteria:

* Patients with idiopathic cardiomyopathy

Exclusion Criteria:

* Post heart surgery
* Congenital heart disease

Primary outcomes:
measure: Number of participants with Improvement of heart function
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
References:
Clinical trial NCT05288114: Signal Relief Patch in Musculoskeletal Pain
Official title: A Pilot Study of the Signal Relief Patch for the Treatment of Musculoskeletal Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Musculoskeletal Pain
Lead sponsor: Signal Relief
Sponsor class: INDUSTRY
Collaborators: name: Proxima CRO
name: ITC Imaging, LLC
First posted: 2022-03-18
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: assess the efficacy of the Signal Relief patch for the management of general musculoskeletal pain

Detailed description: The Signal Relief Patch is an innovative, non-invasive technology that exists as a thin, flexible patch. The patch contains no drugs, wires, or batteries. Nano-capacitors utilized within the Signal Relief Patch were originally developed to replace military antenna systems with no additional power supply. Since development, it was incidentally found that these nano-capacitors may help control pain by working with the body's electrical system. Although the details of how these nano-capacitors facilitate the alleviation of pain are still under investigation, the possibility of reducing pain through a non-invasive, nonpharmacological method is extremely appealing.

Eligibility criteria: Inclusion Criteria:

1. Male or female subject aged ≥ 18 years.
2. Currently seeking treatment for chronic musculoskeletal pain management.
3. Visual analog scale score \> 4 at baseline.
4. Willing to refrain from the use of prescription pain medications during study participation.
5. Able and willing to provide informed consent.

Exclusion Criteria:

- 1. Receiving other investigational agents or on another clinical trial. 2. In emergent need for pain management. 3. Acute injury requiring rapid intervention or treatment. 4. The subject is using prescription medications (e.g., celecoxib, codeine, oxycodone, prednisone, etc.) for pain management regularly or PRN.

5. The subject is currently undergoing or planning to begin physical therapy. 6. The subject is planning to begin a new exercise routine. 7. Subject has implantable pain device, pacemaker, defibrillator, or other neuromodulation implantable device 8. Known to be pregnant.

Primary outcomes:
measure: % change in Pain Baseline to End
timeFrame: 7 days
Secondary outcomes:
measure: Improvement in brief pain inventory score baseline to end 0-10 scale; 0 being no pain, 10 being worst pain
timeFrame: 7 days
measure: change in pain medication use baseline to end
timeFrame: 7 days
Other outcomes:
measure: Exploratory
timeFrame: 7 days
Locations:
city: Scottsdale
country: United States
facility: Valley of the Sun Institute for Pain Management
state: Arizona
city: Sedona
country: United States
facility: Helios Health
state: Arizona
Study officials:
References:
Clinical trial NCT04340414: Safety and Effectiveness of Low-flow ECMO Driving by CVVH Machine in Severe NCP
Official title: Safety and Effectiveness Study of Low Flow Extracorporeal Membrane Oxygenation（CO2 Removal） Driving by Continuous Hemofiltration Machine the Severe New Corovirus Pneumonia (NCP)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COVID-19
ECMO
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2020-04-09
Enrollment: 10
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: assess the safety and effectiveness of using low-flow extracorporeal membrane oxygenation(CO2 removal) driving by CVVH machine in the severe NCP patients


Eligibility criteria: Inclusion Criteria:

* 1. NCP with severe acute respiratory distress syndrome with ratio of partial pressure of arterial oxygen over fraction of inspired oxygen (PaO2:FiO2)\<150 and PEEP \>10cmH2O
* 2. Driving pressure\> 20cmH2O
* 3. RR\>30bpm
* 4.PaCO2\>55cmH2O and/or PH\>7.3

Exclusion Criteria:

* 1. poor venous vascular condition and unavaible for central venous catheter placement

Primary outcomes:
measure: PaCO2
timeFrame: Day 1
measure: Driving Pressure
timeFrame: Day 1
measure: Tidal volume
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Yun Long
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospit
name: Yun Long
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ding X, Chen H, Zhao H, Zhang H, He H, Cheng W, Wang C, Jiang W, Ma J, Qin Y, Liu Z, Wang J, Yan X, Li T, Zhou X, Long Y, Zhang S. ECCO2R in 12 COVID-19 ARDS Patients With Extremely Low Compliance and Refractory Hypercapnia. Front Med (Lausanne). 2021 Jul 8;8:654658. doi: 10.3389/fmed.2021.654658. eCollection 2021.
Clinical trial NCT04505514: Single Dose Intravenous Iron Isomaltoside in Combination With Oral Iron vs Oral Iron Monotherapy in Patients With Anemia After Postpartum Haemorrhage
Official title: Single Dose Intravenous Iron Isomaltoside in Combination With Oral Iron vs Oral Iron Monotherapy in Patients With Anemia After Postpartum Haemorrhage: A Single-blinded, Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Post Partum Hemorrhage
Anemia
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2020-08-10
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigator's study is going to compare effectiveness of single dose intravenous iron in combination with oral iron versus oral iron monotherapy in correcting haemoglobin deficit, replenishing iron stores and improving clinical symptoms in women with post-partum anaemia after postpartum hemorrhage without increasing the rate of adverse outcomes.


Eligibility criteria: Inclusion Criteria:

* women who underwent spontaneous vaginal delivery with Post partum hemorrhage (PPH) ≥ 500ml OR women who underwent lower segment caesarean section with PPH ≥ 1000 ml
* post PPH haemoglobin level ≤ 10.0 g/dl measured within 48hrs after delivery and stabilisation \& resuscitation.
* ≥ 18 years of age
* Proficient in Malaysian language or English language
* Willingness to consent for blood taking and attending follow-up at 2 weeks and 6 weeks

Exclusion Criteria:

* refused consent to participate in trial
* history of hemolytic anemia, Thalassemia , and sickle cell anemia
* women with signs of sepsis (clinical or laboratory evidence-intrapartum fever \>38.5 degrees with abnormal vital signs, positive blood culture)
* clinical or laboratory evidence of hepatic or renal, cardiovascular and hemolytic abnormalities
* history of active severe acid peptic disorder, esophagitis or hiatus hernia and malabsorption syndrome.
* Severe symptoms of anemia including dyspnoea at rest, angina pectoris, syncope or transient ischemic attacks.
* history of severe asthma, eczema or other atopic allergy
* known allergy to iron
* patients with known immune or inflammatory conditions (e.g. systemic lupus erythematosus, rheumatoid arthritis).

Primary outcomes:
measure: Hemoglobin concentration (g/dL)
timeFrame: Six weeks after intervention
measure: Serum iron concentration
timeFrame: Six weeks after intervention
measure: Serum ferritin concentration
timeFrame: six weeks after intervention
Secondary outcomes:
measure: General fatigue score
timeFrame: Six weeks after intervention
measure: Number of participants that had adverse effects to intravenous iron
timeFrame: Up to six weeks after intervention
measure: Blood transfusion requirement
timeFrame: Up to six weeks after intervention
Other outcomes:
Locations:
city: Petaling Jaya
country: Malaysia
facility: University of Malaya Medical Centre
state: Wilayah Persekutuan Kuala Lumpur
Study officials:
References:
Clinical trial NCT03422614: Pathophysiology of Inborn Immunodeficiencies
Official title: Pathophysiologie Angeborener Immundefekte
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Primary Immune Deficiency Disorder
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2018-02-06
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with PID and healthy controls of all ages might be tested, recruitment is in a tertiary care hospital setting

Brief summary: The pathophysiology of primary immunodeficiencies (PID), which encompass a broad range of different diseases with susceptibility to infection and/or a deregulated inflammatory response, is poorly understood. Available treatments are often not specific for a distinct target and might be associated with side effects. To elucidate pathophysiology of different PIDs, stool, urine, blood, tissue biopsies and/or bone marrow will be collected and analysed for anti-microbial activity and inflammatory response. In a second step, targeted treatment for different PIDs might be developed preclinically and ex vivo according to underlying pathophysiology.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of an inborn error of immunity (primary immunodeficiency, PID)
* Clinically healthy (non-age matched) volunteer

Exclusion Criteria:

* exclusion of an inborn error of immunity
* secondary immunodeficiency
* refusal to enter the study

Primary outcomes:
measure: Characterisation of cellular phenotype in different PIDs
timeFrame: immediately after sampling of biological specimen or up to 10 years later from frozen samples
measure: Characterisation of functional phenotype in different PIDs
timeFrame: immediately after sampling of biological specimen or up to 10 years later from frozen samples
Secondary outcomes:
measure: Identification of potential targets for pathophysiology-specific treatment, or for curative treatment such as gene therapy for different PIDs ex vivo
timeFrame: immediately after sampling of biological specimen or up to 10 years later from frozen samples
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Children's Hospital Zurich
Study officials:
affiliation: University Children's Hospital, Zurich
name: Janine Reichenbach, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02078414: Continued Use of Effective Contraception After Use of Emergency Contraception
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Emergency Contraception
Contraception
Reproductive Health
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2014-03-05
Enrollment: 7
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women without contraception or with a failed contraceptive method seeking emergency contraception

Brief summary: Women using an emergency contraceptive method must use back up protection for 1-2 weeks depending on method. The Copper-IUD is the most effective emergency contraceptive method. The investigators wish to explore if women choosing the Cooper IUD have a higher frequency of use of an effective contraceptive method 3 months and 6 months after the use of an emergency contraceptive method than women who choose to use the emergency contraceptive pill EllaOne (ulipristal acetate).


Eligibility criteria: Inclusion Criteria:

* women over 18 years
* eligible for all emergency contraception

Exclusion Criteria:

* previous conisation
* known stenosis of the cervix
* signs of ongoing genital infection
* known uterine anomaly
* Known bleeding disorder

Primary outcomes:
measure: Use of an effective contraceptive method
timeFrame: 6 months after emergency contraceptive use
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: RFSU clinic
Study officials:
References: