louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04025112: Randomized Clinical Trial Comparing Rehabilitation Robotic Versus Conventional After Breast Cancer Surgery
Official title: Randomized Clinical Trial Comparing Rehabilitation Robotic Versus Conventional in Postoperative Period of Patients Submitted to Surgical Treatment of Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Keywords: Breast cancer
Rehabilitation
Robotics
Lead sponsor: Barretos Cancer Hospital
Sponsor class: OTHER
First posted: 2019-07-18
Enrollment: 108
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to evaluate the effects of rehabilitation robotics in upper limb functionality involved in the surgical treatment of breast cancer. The study will be conducted following the delineation of randomized clinical trial. It will be assessed 108 women aged between 30 and 60 years, submitted to surgical treatment of breast cancer and axillary dissection.

Detailed description: Breast cancer is one of the most common neoplasia types, with greater involvement in the female population, showing a high mortality rate in Brazil, due to diagnosis in advanced stages. With the increased survival of women treated for breast cancer, the evaluation of the effect of therapeutic resources for the morbidities resulting from surgical treatment of breast cancer are essential. The aim of this study is to evaluate the effects of rehabilitation robotics in upper limb functionality involved in the surgical treatment of breast cancer. The study will be conducted following the delineation of randomized clinical trial. It will be assessed 108 women aged between 30 and 60 years submitted to surgical treatment of breast cancer and axillary dissection, divided between two equal groups: control group (GC) - composed of women who had undergone conventional rehabilitation and experimental group (GE) - composed of women who had undergone rehabilitation robotics. The data obtained in the study aim to improve the forms of intervention against the functional alterations resulting from surgical treatment.

Eligibility criteria: Inclusion Criteria:

* Women submitted to quadrantectomy, simple mastectomy, radical mastectomy or modified radical mastectomy with complete axillary dissection.
* Women from 30 to 60 years old.
* Postoperatory range from 20 to 80 days.

Exclusion Criteria:

* Bilateral surgery
* Radiotherapy treatment in progress
* Upper limb metastasis

Primary outcomes:
measure: Pain classification change
timeFrame: "15 days" and "30 days"
measure: Arm strength change
timeFrame: "15 days" and "30 days"
measure: Change in the amplitude of arm movement
timeFrame: "15 days" and "30 days"
measure: Upper limb disability change
timeFrame: "15 days" and "30 days"
Secondary outcomes:
measure: Quality of life change
timeFrame: "15 days" and "30 days"
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02618512: A Open Label Study in Previously Studied, SBC-103 Treatment Naïve MPS IIIB Subjects to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics/Efficacy of SBC-103 Administered Intravenously
Official title: A Phase I/II Open Label Study in Previously Studied, SBC-103 Treatment Naïve MPS IIIB Subjects to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics/Efficacy of SBC-103 Administered Intravenously
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Mucopolysaccharidosis III, Type B (MPS IIIB)
Sanfilippo B
Lead sponsor: Alexion Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2015-12-01
Enrollment: 3
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study evaluated the safety and tolerability of intravenous (IV) administration of SBC-103 in previously studied, SBC-103 treatment naïve patients with mucopolysaccharidosis III, type B (MPS IIIB, Sanfilippo B) who participated in the NGLU-CL01 study. The NGLU-CL01 study was a non-interventional study that evaluated structural brain abnormalities and blood brain barrier (BBB) integrity by magnetic resonance imaging (MRI) and cerebrospinal fluid/serum albumin index.


Eligibility criteria: Participants from NGU-CL01 study were enrolled into the NGLU-CL01-T study. Subjects who met all of the inclusion criteria and none of the exclusion criteria were eligible to participate in this study.

Primary outcomes:
measure: Safety and Tolerability of SBC-103
timeFrame: Planned duration was baseline to 164 weeks but due to early termination of the study, actual is 96 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
Study officials:
References:
Clinical trial NCT03329612: Remote Ischemic Preconditioning in ACS Patients
Official title: Remote Ischemic Preconditioning in ACS Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Acute Coronary Syndrome
Renal Insufficiency
Ischemia, Myocardial
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2017-11-06
Enrollment: 0
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: Remote ischemic preconditioning is a process of serial blood pressure cuff inflations and deflations that are performed prior to a procedure and have been shown in various other areas (coronary bypass surgery, vascular surgery, ST elevation myocardial infarctions) to decrease the rates of adverse events related to ischemic burden and renal injury. This procedure has not yet been studied in the population presenting with an acute coronary syndrome (ACS), even though ACS patients represent the majority of patients seen in the catheterization lab. The purpose of this study is to evaluate the efficacy of this simple and safe procedure in this particular population.


Eligibility criteria: Inclusion Criteria:

- Presenting with an acute coronary syndrome including non-ST elevation myocardial infarction or unstable angina on optimal medical therapy with aspirin, P2Y12 inhibitors, unfractionated heparin, statin, +/- beta blocker, +/- ace inhibitor

Exclusion Criteria:

* Presenting with ST elevation myocardial infarction
* Patients requiring circulatory support
* Need for emergent percutaneous coronary intervention
* Systemic hypotension (systolic blood pressure \<90 mmHg)
* Patients in cardiogenic shock defined by requiring inotropes or vasopressors
* Patients currently on hemodialysis
* Presence of an arteriovenous dialysis fistula or graft or lymphedema in either arm
* Patients enrolled in other active cardiovascular investigational studies
* Severe comorbidities with a life expectancy of less than 6 months
* Pregnant or lactating women
* Patients unable to provide consent
* Patient taking the medication glibenclamide for treatment of diabetes

Primary outcomes:
measure: Ischemic Burden
timeFrame: 48-72 hours
Secondary outcomes:
measure: Clinical Outcomes
timeFrame: 6 months
measure: Renal Injury
timeFrame: 48-72 hours
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
Study officials:
affiliation: Henry Ford Health System
name: Gerald Koenig, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03455712: Impact of GWG Tool on Patient Knowledge
Official title: Impact of a Patient Education Intervention on Maternal Knowledge of Gestational Weight Gain Recommendations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Gain
Pregnancy Related
Keywords: Pregnancy
Gestational weight gain
Weight gain
Patient education
Patient knowledge
Institute of Medicine
Lead sponsor: MetroHealth Medical Center
Sponsor class: OTHER
First posted: 2018-03-06
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects to be enrolled into the intervention and standard-of-care groups depending on their gestational age at the time of consent during the expected 2 month period of enrollment. Any subject who is between 6 weeks 0 days and 14 weeks 6 days of pregnancy at the time of consent and who has had no prior prenatal visits will be enrolled in the intervention group. Any subject who is between 15 weeks 0 days to 22 weeks 6 days of pregnancy at the time of consent and who has had at least one prior prenatal visit will be enrolled in the control group.
Primary purpose: OTHER

Brief summary: Women with singleton pregnancies at one outpatient clinic to be recruited for controlled clinical trial. Over eight weeks, women 15 0/7--22 6/7 weeks' with at least one prior prenatal visit to be enrolled in the control group. Women 6 0/7--14 6/7 weeks' to be enrolled in the intervention group at their first prenatal visit and to receive a pregnancy-specific gestational weight gain card. Women to be encouraged to record their weight at each prenatal care visit. All women to complete a GWG knowledge--based questionnaire at 15 0/7-22 6/7 weeks'.


Eligibility criteria: Inclusion Criteria:

* Singleton gestation
* Primary prenatal care at MetroHealth Medical Center
* Planning to deliver at MetroHealth Medical Center

Exclusion Criteria:

* Any inclusion criteria not met
* Prior diagnosis of eating disorder
* Inadequate knowledge of English language

Primary outcomes:
measure: Pregnancy-specific topic/guideline questionnaire responses
timeFrame: Outcome assessed up to 23 weeks gestation
Secondary outcomes:
measure: Pregnancy-specific topic/guideline questionnaire responses
timeFrame: Outcome assessed up to 23 weeks gestation
Other outcomes:
Locations:
Study officials:
affiliation: Case Western Reserve University School of Medicine, MetroHealth Medical Center
name: Erica Berggren, MD, MSCR
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06336512: Trimester Sequential Estimation of Serum Zonulin as a Predictor of Gestational Diabetes Mellitus
Official title: Trimester Sequential Estimation of Serum Zonulin Overrides Glucose Homeostasis Biomarkers for Prediction of Gestational Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2024-03-28
Enrollment: 70
Sex: FEMALE
Minimum age (years): 22
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Newly Pregnant Women with singleton fetus
Primary purpose: DIAGNOSTIC

Brief summary: Gestational diabetes mellitus (GDM) is the development of glucose intolerance (GI) during pregnancy in a previously normoglycemic (NG) woman and associated with insulin resistance (IR). GDM is the most prevalent metabolic disorder during pregnancy and became a major public health problem for being usually diagnosed and detected after 24 gestational weeks (GW), while its complications can occur much earlier and this may explain its burden on maternal and fetal welfare. Human zonulin is a surrogate marker of intestinal permeability and can be utilized as biomarker for intestinal barrier function. Zonulin-mediated increase in intestinal permeability plays a role in the pathogenesis of insulin resistance, obesity, DM and metabolic syndrome. The increasing global prevalence of GDM with its associated risk of poor pregnancy and long-term risks for the mother and the offspring may lead to the production of new generation of diabetics.


Eligibility criteria: Inclusion Criteria:

* Pregnant Women with singleton fetus

Exclusion Criteria:

* Women with morbid obesity with body mass index ≥35 kg/m2;
* Had manifest DM, irrespective of being controlled or not;
* Bowel-related disorders;
* Autoimmune disorders;
* History of previous GDM.

Primary outcomes:
measure: Estimation of Gestational DM
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Banhā
country: Egypt
facility: Benha university
state: El- Qalyobia
Study officials:
References:
Clinical trial NCT05986812: SWE in Assessment of CKD Patients
Official title: Feasibility of Shear Wave Elastography in Assessment of Renal Stiffness in Chronic Kidney Diseased Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Elastography ,CKD Patients
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: CKD patients which ages from 18 to 75 years old

Brief summary: Elastography is a developing technique to assess tissue elasticity. It is software that can be integrated to the ultrasonography machines. Shear wave Elastography (SWE) is an Elastography technique that does not require external pressure on the tissue and supplies quantitative data. It uses real-time short-duration acoustic push pulse to generate shear waves that propagate perpendicular to the main ultrasound beam. When the waves hit the targeted tissue, the tissue is "pushed" in the direction of propagation, causing it to temporarily deform or displace. The ultrasound scanner can monitor the tissue displacement, measuring the time-to-peak displacement and the recovery time. Shear wave velocity increases in diseased tissues, which can be significantly stiffer than normal ones. The parameters are expressed in pressure units of kilopascals (kPa) and velocity (m s-1). SWE have been used to study breast, thyroid, prostate and liver diseases. However, the application of SWE in assessment of renal fibrosis in CKD patients is still unclear.


Eligibility criteria: Inclusion Criteria:

* The patients are those older than 18 years diagnosed with CKD based on the KDIGO (Kidney Disease Improving Global Outcomes) definition i.e. eGFR less than 60 mL/min and/or the presence of markers of kidney damage (pathological albuminuria of at least 30 mg per 24 hours or proteinuria, hematuria, casts) persisting for more than 3 months.

Exclusion Criteria:

* Patients whose BMI \>35kg/m 2 Any condition that precludes visualization of the kidney by ultrasound or transmission of shear waves as pregnancy or marked ascites patients with surgical kidney problems like hydro or pyonephrosis patients unwilling to complete the study. Patients with a history of renal replacement therapy (hemodialysis, peritoneal dialysis) , renal transplant, or acute kidney injury within the last 3 months Patients with cystic kidney disease Patients with renal masses

Primary outcomes:
measure: The primary outcome of the study is the difference in renal SWE values between normal subjects and CKD patients .
timeFrame: From 2 to 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05295446: Functional GI Disease Registry
Official title: Functional GI Disease Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Functional Gastrointestinal Disorders
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2022-03-25
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients 18 years or older with a functional GI disorder

Brief summary: The goal of this study is to establish a prospective observational cohort of individuals with functional GI disorders (functional constipation, irritable bowel syndrome, chronic nausea, functional diarrhea, and functional dyspepsia, as well as a subset of these individuals starting neuromodulation for their functional GI disorder) and collect clinical information and specimens. This information will be used in order to establish a patient registry with detailed clinical data and a specimen repository for future research as well as to specifically identify environmental, genetic, physiological, and psycho-social factors associated with functional GI disorders.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Rome IV criteria for a functional GI disorder

Exclusion Criteria:

* Acute illness
* Known bleeding disorder
* Awaiting transplantation
* Known diagnosis of Inflammatory Bowel Disease
* Use of antibiotics in last 2 months

Primary outcomes:
measure: Single Nucleotide Polymorphism (SNP) genotyping
timeFrame: Baseline visit
measure: Whole genome analysis
timeFrame: Baseline visit
measure: Proteomics
timeFrame: Baseline visit
measure: Microbiome analysis
timeFrame: Baseline visit
measure: Microbiome analysis
timeFrame: 3 months after enrollment
measure: Microbiome analysis
timeFrame: 6 months after enrollment
measure: Microbiome analysis
timeFrame: 1 year after enrollment
measure: Diet and Lifestyle Questionnaire
timeFrame: Baseline visit
measure: Diet and Lifestyle Questionnaire
timeFrame: 3 months after enrollment
measure: Diet and Lifestyle Questionnaire
timeFrame: 6 months after enrollment
measure: Diet and Lifestyle Questionnaire
timeFrame: 1 year after enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Kyle Staller, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06481046: Treatment of Rotator Cuff Tears With Platelet Rich Plasma
Official title: Treatment of Rotator Cuff Tears With Platelet Rich Plasma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Rotator Cuff Tears
Rotator Cuff Tendinitis
Lead sponsor: The Foundation for Orthopaedics and Regenerative Medicine
Sponsor class: OTHER
First posted: 2024-07-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
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 evaluate the safety and effectiveness of dual platelet rich plasma (PRP) injections into the rotator cuff insertion and the area of the tendon proximal to the insertion.

Detailed description: Patients who have rotator cuff pathology as established by clinical exam and confirmed with MRI and have failed activity modification, will be enrolled in this study. They will receive dual platelet rich plasma (PRP) injections, one into the rotator cuff insertion and one into the area of the tendon proximal to the insertion, in one treatment session. PRP will be prepared through a double spin technique to create two 4 cc doses for injection. Patients will evaluated at 6 months, 1 year and two years for improvement in symptoms.

Eligibility criteria: Inclusion Criteria:

* Rotator cuff pathology established by exam
* Rotator cuff pathology confirmed with MRI.
* Failure to improve with activity modification and physical therapy
* Willingness to stop all NSAID medication

Exclusion Criteria:

* Additional significant shoulder pathology seen on xray or MRI including: severe arthritis, significant superior labrum anterior postierior (SLAP) Type II lesions and intra-articular loose bodies.
* Shoulder surgery within 6 months.
* Presence of full thickness rotator cuff tears in patients amenable to surgical repair.

Primary outcomes:
measure: Quick Disabilities of the Arm, Shoulder and Hand Score (Quick-DASH)
timeFrame: change from baseline to 6 months
measure: Quick Disabilities of the Arm, Shoulder and Hand Score (Quick-DASH)
timeFrame: change from baseline to 12 months
measure: Quick Disabilities of the Arm, Shoulder and Hand Score (Quick-DASH)
timeFrame: change from baseline to 24 months
Secondary outcomes:
measure: Visual Analog Scale (VAS) for pain
timeFrame: change from baseline to 6 months
measure: Visual Analog Scale (VAS) for pain
timeFrame: change from baseline to 12 months
measure: Visual Analog Scale (VAS) for pain
timeFrame: change from baseline to 24 months
measure: Global Improvement
timeFrame: change from baseline to 6 months
measure: Global Improvement
timeFrame: change from baseline to 12 months
measure: Global Improvement
timeFrame: change from baseline to 24 months
Other outcomes:
Locations:
city: Glenview
country: United States
facility: Illinois Sportsmedicine and Orthopaedic Centers
state: Illinois
Study officials:
affiliation: Illinois Sportsmedicine and Orthopaedic Centers
name: Chadwick Prodromos, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05680246: Long-term Outcomes After Prolonged Dual Hypothermic Oxygenated Machine Perfusion of Donor Livers (DHOPEPROLONG)
Official title: Prospective Observational Study to Investigate Long-term Outcomes After Prolonged Dual Hypothermic Oxygenated Machine Perfusion of Human Donor Livers (DHOPEPROLONG)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Liver Transplantation
Keywords: machine preservation
machine perfusion
donor organ preservation
hypothermic oxygenated machine perfusion
donor liver machine perfusion
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2023-01-11
Enrollment: 500
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: Adult liver transplant recipients

Brief summary: End-ischemic dual hypothermic oxygenated machine perfusion (DHOPE) of human donor livers mitigates ischemia-reperfusion injury, resulting in a reduction of post-reperfusion syndrome, early allograft dysfunction and biliary complications, when compared with static cold storage. End-ischemic DHOPE can be used to prolong donor liver preservation time for up to 24 hours. According to IDEAL-D (Idea, Development, Exploration, Assessment, Long term study-Framework for Devices), scientific evidence for prolonged DHOPE has currently reached stage 3. Assessment of long-term outcomes after prolonged DHOPE preservation based on real-world data (i.e., IDEAL-D stage 4) is currently still lacking.

Detailed description: The aim of this study is to assess long-term outcomes after transplantation of donor livers preserved by prolonged hypothermic oxygenated machine perfusion (DHOPE-PRO).

Eligibility criteria: Inclusion Criteria:

* Adult patients (\>18 years) who underwent liver transplantation of donor livers preserved with end-ischemic DHOPE for \>4 hours

Exclusion Criteria:

* None

Primary outcomes:
measure: Death-censored graft survival
timeFrame: Up to 5-years
Secondary outcomes:
measure: Overall graft survival
timeFrame: Up to 5-years
measure: overall patient survival
timeFrame: Up to 5-years
measure: arterial and biliary complication-free survival (ABCFS)
timeFrame: Up to 5-years
measure: incidence of biliary complications
timeFrame: Up to 5-years
measure: incidence of vascular complications
timeFrame: Up to 5-years
measure: incidence of acute cellular rejection
timeFrame: Up to 5-years
measure: incidence of chronic rejection
timeFrame: Up to 5-years
measure: incidence of re-transplantation
timeFrame: Up to 5-years
measure: incidence of recurrence of primary disease
timeFrame: Up to 5-years
measure: incidence of new-onset chronic kidney disease
timeFrame: Up to 5-years
measure: incidence of new-onset diabetes after transplantation
timeFrame: Up to 5-years
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: University Medical Center Groningen
name: Vincent E de Meijer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: