louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06160154: Minimally Invasive Robot-assisted and Laparoscopic Distal Pancreatectomy in a Pan-European Registry
Official title: Minimally Invasive Robot-assisted and Laparoscopic Distal Pancreatectomy in a Pan-European Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreas Disease
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2023-12-07
Enrollment: 1672
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent laparoscopic or robotic distal pancreatecromy between January 1st 2019 and December 31st 2021

Brief summary: A planned analysis of outcomes among consecutive patients after MIDP from centers participating in the E-MIPS registry (2019-2021). Main outcomes of interest were intraoperative events, major morbidity (Clavien-Dindo grade ≥3) and 30-day/in-hospital mortality.

Detailed description: The European registry for Minimally Invasive Pancreatic Surgery (E-MIPS) is an E-AHPBA endorsed registry with the aim to monitor and safeguard the introduction of MIPS in Europe. International multicenter audit-based studies focusing on outcomes of minimally invasive distal pancreatectomy (MIDP) are lacking.

A planned analysis of outcomes among consecutive patients after MIDP from centers participating in the E-MIPS registry (2019-2021). Main outcomes of interest were intraoperative events, major morbidity (Clavien-Dindo grade ≥3) and 30-day/in-hospital mortality.

Eligibility criteria: Inclusion Criteria:

Data from all patients who underwent laparoscopic or robotic distal pancreatecromy between January 1st 2019 and December 31st 2021 were included

Exclusion Criteria:

Other pancreatic procedures Hybrid approaches (reconstruction phase open) Procedures with insufficient baseline data / missing primary outcome data.

Primary outcomes:
measure: Intraoperative events
timeFrame: 30 days
measure: 30-day/in-hospital mortality.
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, locatie AMC
state: Noord-Holland
Study officials:
References:
Clinical trial NCT02396654: 5D LB Ultrasound in Determination of Fetal Weight in Normal Pregnancy : A Pilot Study
Official title: Accuracy of Five Dimensional Ultrasound Long Bones Fetal Biometry (5DUS LB ) for Prediction of Fetal Weight Compared to Two Dimensional Ultrasound: a Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fetal Weight
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2015-03-24
Enrollment: 56
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Normal pregnant women

Brief summary: 5D and 2D ultrasound will be done to normal pregnant women between 37 to 42 weeks gestation and fetal weight will be estimated using the hadlock formula using biometry measured by both ultrasounds. Accuracy of 5D ultrasound in determining fetal weight will be determined.


Eligibility criteria: Inclusion Criteria:

* 20-40years
* singleton pregnancy
* normal pregnancy

Exclusion Criteria:

* Intrauterine fetal death
* multiple pregnancy
* congenital anomaly
* nonvisualized fetal parts by ultrasound
* maternal medical disorders like diabetes and hypertension

Primary outcomes:
measure: Accuracy of 5D LB ultrasound in determining fetal weight (estimated by hadlock formula - Accuracy of estimated fetal weight by ultrasound will be compared to actual birth weight)
timeFrame: 48hours
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams Maternity Hospital
Study officials:
References:
Clinical trial NCT00593554: Phase 2 Haplotype Mismatched HSCT in Patients With Hematological Malignancies
Official title: A Phase II Trial of Haplotype Mismatched Hematopoietic Stem Cell Transplantation Using Highly Purified CD34 Cells in Patients With Hematological Malignancies
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Myelodysplasia
Chronic Myeloid Leukemia
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2008-01-15
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
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 determine if haplotype-mismatched HSCT is associated with an improvement in treatment-related mortality (TRM) rate at 6 months.


Eligibility criteria: Inclusion Criteria:

* Patients must have histologically documented AML, ALL, MDS, CML, Acute myeloid leukemia (AML) with one or more of the following criteria

  * CR 1 with poor risk features
  * CR 2, or higher order CR
* Acute lymphoblastic leukemia (ALL) with one of the following criteria

  * CR 1 with poor risk features
  * CR 2, or higher order CR
* Myelodysplasia, RAEB I
* Donor has been identified
* Age ≤ 65 years.
* Performance Status 0-1.

Exclusion Criteria:

* Patients relapsing \<6 months after autologous SCT are not eligible.
* Patients with active infections requiring oral or intravenous antibiotics are not eligible for enrollment until resolution of infection.
* Non-pregnant and non-nursing

Primary outcomes:
measure: Treatment-related Mortality (TRM) Rate at 6 Months After Transplantation
timeFrame: thru 6 months after transplant
Secondary outcomes:
measure: Regimen-related Toxicity
timeFrame: Up to 1 year
measure: Time to Neutrophil Engraftment
timeFrame: Transplant (Day 0) up to 1 year
measure: Time to Platelet Engraftment
timeFrame: Transplant (Day 0) up to 1 year
measure: Acute Graft vs. Host Disease (GvHD)
timeFrame: Up to 1 year
measure: Chronic Graft vs. Host Disease (GvHD)
timeFrame: Up to 1 year
measure: Frequency of Infection
timeFrame: Day 0 through 1 year post transplantation
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Cancer Center
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: Sherif Farag, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05056233: Systane Hydration in Subjects Undergoing Cataract Surgery
Official title: Systane Hydration in Subjects Undergoing Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye Disease
Cataract
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2021-09-24
Enrollment: 35
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 primary objective of this study is to demonstrate reduced corneal staining with use of Systane Hydration among subjects with dry eye disease (DED) undergoing routine cataract removal and monofocal intraocular lens (IOL) implantation.

Detailed description: Subjects will attend 6 scheduled study visits for an individual duration of participation of 6 weeks. One eye (study eye) will be followed.

Eligibility criteria: Key Inclusion Criteria:

* Seeking routine (age-related) cataract extraction with monofocal intraocular lens implantation;
* Able to provide informed consent;
* Willing and able to attend all study visits and comply with treatment;
* Have dry eyes per dry eye questionnaire.
* Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

* Subjects who use of ocular drugs, other than the test article (for treatment group only) and other standard of care postoperative medications, during the study;
* History of intraocular or corneal surgery in the study eye;
* Use of artificial tears, steroids, or other medications as specified in the protocol;
* Clinically significant corneal scarring;
* Corneal degeneration, retinal degeneration or other ocular pathology as specified in the protocol.
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: Corneal staining
timeFrame: Up to Day 30 post-operative
Secondary outcomes:
measure: DEQ-5 Score
timeFrame: Up to Day 30 post-operative
measure: Ocular Comfort Questionnaire Score: My eyes are comfortable
timeFrame: Up to Day 30 post-operative
measure: Ocular Comfort Questionnaire Score: At the end of the day, my eyes feel comfortable
timeFrame: Up to Day 30 post-operative
measure: Ocular Comfort Questionnaire Score: My eyes are comfortable all day long
timeFrame: Up to Day 30 post-operative
Other outcomes:
Locations:
city: Valladolid
country: Spain
facility: Principal Investigator
Study officials:
affiliation: Alcon Research, LLC
name: Sr. Clinical Trial Lead, CDMA Surgical
role: STUDY_DIRECTOR
References:
Clinical trial NCT03838354: A Clinical Trial of the Low Dose Chidamide in the Management of Refractory ITP
Official title: A Prospective, Single-arm Clinical Trial of the Low Dose Chidamide in the Management of Refractory Immune Thrombocytopenia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Thrombocytopenia
Keywords: ITP
Chidamide
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2019-02-12
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Nowdays HDACi's were more and more focused on the anti-inflammatory and immunomodulatory activities,independent of their known proapoptotic or cell cycle arrest actions on malignant cells. Low concentrations of HDACi's are effective in reducing inflammation and autoimmune response in humans with juvenile idiopathic arthritis and animal models of inflammatory bowel disease and arthritis. The project was undertaking by Qilu Hospital of Shandong University in China. In order to report the efficacy and safety of the low dose chidamide in the management of refractory ITP.

Detailed description: The investigators are undertaking a prospective, open, multicentre trial of 30 refractory ITP adult patients from 5 medical centers in China. 1/2 of the participants are randomly selected to receive Chidamide in 2.5 mg po tiw, every four weeks for one cycle and it will be given three cycles. The other part will receive Chidamide in 5 mg po tiw, every four weeks for one cycle and it will be given three cycles. The treatment was discontinued after 3 months without blood index reaction. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study. In order to report the efficacy and safety of the low dose chidamide in the management of refractory ITP.

Eligibility criteria: Inclusion Criteria:

* Refractory ITP patients need of treatment(s) to minimize the risk of clinically significant bleeding primary ITP confirmed by excluding other supervened causes of thrombocytopenia

Exclusion Criteria:

* pregnancy hypertension cardiovascular disease diabetes liver and kidney function impairment HCV, HIV, HBsAg seropositive status patients with systemic lupus erythematosus and/or antiphospholipid syndrome

Primary outcomes:
measure: Platelet count
timeFrame: the third month after the first dose of Chidamide
Secondary outcomes:
measure: Therapy associated adverse events
timeFrame: up to 1 year per subject
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu hospital, Shandong University
state: Shandong
Study officials:
References:
Clinical trial NCT04830254: Correlation Between Selected Haematological and Doppler Ultrasonic Parameters in Peripheral Arterial Diseased Patients
Official title: Correlation Between Selected Hematological and Doppler Ultrasonic Parameters After Electrical Stimulation in Peripheral Arterial Diseased Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-04-05
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Forty patients of both sexes, aged between 50 and 60 years, were chosen from an outpatient vascular clinic in the El Sahel Education Hospital. Patients have been examined and referred to by a vascular specialist.

Detailed description: The participants were divided randomly into two groups of equal numbers. The study group got low-frequency TENS (4 Hz frequency, pulse duration 200 μs) which was administered through surface electrodes for 45 min per session, supramaximal stimulation for T12, L1, and L2 sympathetic ganglions that innervate the lower extremity for 45 min per session, three times per week and for 12 weeks. Control Group that received placebo stimulation as provided by the same TENS device but with a zero volt after 10 s of stimulation.

Eligibility criteria: Inclusion Criteria:

1. Unilateral Leriche-Fontaine stage-II PAD
2. Both sexes
3. Aged 50 to 60 years
4. Outpatients
5. Clinically stable
6. Sedentary
7. Not participating in any physical activity last 3 months

Exclusion Criteria:

1. Walking disorders related to orthopedic or neuromuscular disease
2. Renal insufficiency requiring dialysis (Renal diseases)
3. Known and documented myopathy
4. Progressive cancer
5. Associated progressive disease causing a deterioration in general health
6. Participation in another research protocol
7. Skin disorder making it impossible to use TENS
8. Absolute contraindication to physical activity
9. Presence of a pacemaker/defibrillator

Primary outcomes:
measure: Red cell distribution width (RDW)
timeFrame: change from baseline to after 12 weeks
measure: Mean platelet volume(MPV)
timeFrame: change from baseline to after 12 weeks
measure: Ankle peak systolic velocity (APSV)
timeFrame: change from baseline to after 12 weeks
measure: Arterial diameter
timeFrame: change from baseline to after 12 weeks
Secondary outcomes:
measure: Actual claudication distance
timeFrame: change from baseline to after 12 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Physical Therapy
Study officials:
References:
Clinical trial NCT05782933: Efficacy of Rituximab Combined With Cyclosporine in the Treatment of Idiopathic Membranous Nephropathy
Official title: Efficacy and Safety of Low Dose Rituximab Combined With Cyclosporine in the Treatment of Idiopathic Membranous Nephropathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Idiopathic Membranous Nephropathy
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2023-03-24
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Idiopathic membranous nephropathy (IMN) is one of the common types of primary glomerular diseases and the most common cause of nephrotic syndrome in adults.

Poticelli regimen is the classic treatment, but cyclophosphamide has many toxic side effects. The period of glucocorticoid therapy is relatively long, and the adverse reactions caused by glucocorticoid therapy cannot be ignored. For patients who are unwilling to receive glucocorticoids and cyclophosphanide or who have treatment contraindications, cyclosporine can be used, mainly cyclosporine and tacrolimus, with the rapid overall effect but a high short-term relapse rate. In recent years, rituximab therapy has become a first-line treatment, with a high remission rate, and few side effects, but expensive. In terms of efficacy alone, the above regimen did not exceed Poticelli regimen. However, the toxic side effects of rituximab, cyclosporine may be lower than that of Poticelli regimen. Based on the preliminary experiment, this study explored a new treatment plan: low-dose rituximab combined with cyclosporine in the treatment of IMN, the efficacy is not inferior to Poticelli regimen, but the side effects are significantly reduced. The result will provide a good choice for IMN patients.


Eligibility criteria: Inclusion Criteria:

1. age 18-70 years; serum albumin level \<30 g/L;
2. estimated glomerular filtration rate (eGFR according to the CKD-EPI formula) ≥60 mL/min per 1.73 m2;
3. patients with a moderate risk of IMN and decline \<50% in proteinuria despite blockade of the renin-angiotensin system 3 months before randomization;
4. patients at high risk or very high risk of IMN.

Exclusion Criteria:

1. secondary causes of MN;
2. being pregnant or breastfeeding;
3. uncontrollable active infectious disease;
4. immunosuppressive treatment in the preceding 3 months.

Primary outcomes:
measure: remission of nehprotic syndrome
timeFrame: 12 months
Secondary outcomes:
measure: Complete remission of nehprotic syndrome
timeFrame: 12 months
measure: adverse events
timeFrame: 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
Study officials:
References:
Clinical trial NCT01820533: Survey of Smokers Treated in the Emergency Department (ED) on Ownership and Usage of Cell Phones
Official title: Survey of Smokers Treated in the ED on Ownership and Usage of Cell Phones
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Smoking
Keywords: Smoking
Cellular phones
Low income population
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: National Institutes of Health (NIH)
First posted: 2013-03-28
Enrollment: 775
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be current patients in the Yale New Haven Hospital Emergency Department who were previously identified as smokers.

Brief summary: To study ownership and use of cell phones in low-income smokers. This may help us better understand the impact of cell phone ownership plans on low income smokers' access to quitlines. Use of quitlines may be impeded by limited access to landline phones and limited airtime minutes on cell phones.


Eligibility criteria: Inclusion Criteria:

* Age 18 or over
* speak and understand English
* willing and able to give informed consent
* have smoked more than 100 cigarettes lifetime
* are currently a daily or some day smoker

Exclusion Criteria:

* too ill or unable to consent
* not interested in participation
* actively psychotic or mentally ill and unable to give consent
* in police custody
* resides in an extended care facility.

Primary outcomes:
measure: Proportion of participants with lifeline wireless phones
timeFrame: baseline
measure: proportion of participants with limited wireless minutes
timeFrame: baseline
measure: proportion of participants with unlimited wireless minutes
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Yale University
name: Steven L Bernstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02136433: Using Tablets for Upper Extremity Rehabilitation Post Acquired Brain Injury
Official title: Using Tablets for Upper Extremity Rehabilitation Post Acquired Brain Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Brain Injury
Stroke
Keywords: Hand
Rehabilitation
Stroke
Brain-injury
Tablet
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Tel-Aviv Sourasky Medical Center
First posted: 2014-05-13
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to test the effectiveness of training using novel tablet applications for hand function, compared to traditional hand exercises. In addition, we aim to examine brain plasticity following treatment with the new tablet applications. We hypothesize that training with a tablet would prove to be more effective than traditional exercises. We expect to observe neuroplastic changes in the brain in patients who practiced finger movements using the tablet.


Eligibility criteria: Inclusion Criteria:

* At least one week post Brain injury or stroke
* Partial ability to open and close their hand (fingers)
* Full function of the hands prior to the injury or event
* Intact or Corrected vision
* Cognitively intact or mild impairment

Exclusion Criteria:

* Other neurological conditions besides the brain injury or stroke
* Orthopedic conditions of the upper extremity

Primary outcomes:
measure: Change from baseline in score of the Nine Hole Peg Test
timeFrame: An average of one week before intervention and one week after intervention
Secondary outcomes:
measure: The Fugl-Meyer Motor Assessment
timeFrame: An average of one week before intervention and one week after intervention
measure: Grip and pinch strength
timeFrame: An average of one week before intervention and one week after intervention
measure: Visual Analogue Scale
timeFrame: An average of one week before intervention and one week after intervention
measure: The System Usability Scale
timeFrame: An average of one week after intervention
measure: Change from baseline in score of the Action Research Arm Test
timeFrame: An average of one week before intervention and one week after intervention
measure: Self - report compliance
timeFrame: An average of one week after intervention
measure: Satisfaction Questionnaire
timeFrame: An average of one week after intervention
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Sheba
name: Rachel Kizony, PhD
role: STUDY_CHAIR
References:
citation: Rand D, Zeilig G, Kizony R. Rehab-let: touchscreen tablet for self-training impaired dexterity post stroke: study protocol for a pilot randomized controlled trial. Trials. 2015 Jun 18;16:277. doi: 10.1186/s13063-015-0796-9.