louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04698616: Lean Body Mass and Side Effects in Patients With Lymphoma
Official title: The Relation Between Lean Body Mass and Side Effects Induced by Chemotherapy in Patients With Lymphoma: A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Malignant Lymphoma
Keywords: lymphoma
body composition
lean body mass
chemotherapy
quality of life (QOL)
nutritional status
physical activity
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2021-01-07
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients receiving myelosuppressive treatment for malignant lymphoma

Brief summary: The primary purpose is to investigate the relationship between the dose of chemotherapeutic agents per kilogram of lean body mass (LBM) and the development of side effects induced by chemotherapy in patients with lymphoma. Secondarily, the maximum tolerable dose of chemotherapeutics (MTD), patients' quality of life (QOL), nutritional status and physical activity during the course of treatment are estimated.


Eligibility criteria: Inclusion Criteria:

* Patients receiving myelosuppressive treatment for malignant lymphoma assessed by the investigator.
* Legal of age

Exclusion Criteria:

* ECOG Performance Status ≥2
* People who cannot speak and understand Danish
* Pregnant and breastfeeding
* Dementia

Primary outcomes:
measure: Lean Body Mass (LBM)
timeFrame: 8 weeks (two treatment cycles)
Secondary outcomes:
measure: Maximal tolerable dose of chemotherapeutics (microg/ml/kg LBM),
timeFrame: 8 weeks (two treatment cycles)
measure: Quality of life (QOL) (score EORTC)
timeFrame: 8 weeks (two treatment cycles)
measure: nutritional status at inclusion (NRS2002 - scale)
timeFrame: 8 weeks (two treatment cycles)
measure: physical activity (scale - questionaire)
timeFrame: 8 weeks (two treatmenr cycles)
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: University of Copenhagen
state: Frederiksberg
city: Roskilde
country: Denmark
facility: Sjællands Universitetshospital, Hæmatologisk Afdeling H60
Study officials:
affiliation: University of Copenhagen
name: Jens R Andersen, MD,MPA
role: STUDY_CHAIR
References:
Clinical trial NCT01075724: Comparison of a New Patient Warming System Using a Polymer Conductive Warming Under-body and Upper-body Blanket With Forced Air Warming
Official title: Comparison of a New Patient Warming System Using a Polymer Conductive Warming Under-body and Upper-body Blanket With Forced Air Warming During Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypothermia
Keywords: Perioperative Hypothermia Prevention
Accidental Perioperative Hypothermia
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2010-02-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Intraoperative active warming is usually performed by skin warming. There are several forced-air systems on the market; forced air warming is generally described as the most effective yet feasible method of patient warming.

Augustine Biomedical (Eden Prairie, MN, USA) recently introduced a new patient warming system named "Hot Dog" with an active polymer warming upper-body blanket and a new under-body warming mattress. The polymer-heating devices consist of an electronic regulator and the polymer blankets, which are covered with a washable fabric. Conventional mains power the system. The manufacturer claims, that the new system "Hot Dog" (with combination of under body and upper body warming) is as effective as forced air warming, while not having any disadvantages of the forced air system, like: airborne infection, noise, high power consumption and hard-to-clean hose.

The investigators will compare the new Hot Dog patient warming device combination (under body + upper body) with the established warming system, which blows warm air via a mattress over the body of the patients).


Eligibility criteria: Inclusion Criteria:

* The investigators will study 40 patients (18-90 years) undergoing elective orthopedic lower limb surgery at the trauma surgery unit. The patients must have normal weight (20-30 BMI), the duration of surgery should last between 2 - 3 hours.

Exclusion Criteria:

* There will be no other exclusion criteria (except severe peripheral arterial disease in the warmed extremity), as forced air patient warming is routinely used for all patients during this procedure.

Primary outcomes:
measure: Core Temperature at the end of surgery (at time of skin suture)
timeFrame: Single Measurement at Beginning of Skin Suture
Secondary outcomes:
measure: Core temperature increase (°C/time)
timeFrame: From Beginning until End of Surgery
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Oliver Kimberger
Study officials:
References:
Clinical trial NCT01477424: A Drug-Drug Interaction Study of Warfarin and PA21
Official title: A Single-centre, Open-label, Three-period Study of the Pharmacokinetic Effect of PA21 on Warfarin in Healthy Male and Female Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Drug Interaction Potentiation
Keywords: Drug-drug interaction
Pharmacokinetics
PA21
Lead sponsor: Vifor Pharma
Sponsor class: INDUSTRY
First posted: 2011-11-22
Enrollment: 45
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine if Warfarin is affected by PA21.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers
* Written informed consent

Exclusion Criteria:

* No significant medical conditions
* Pregnancy

Primary outcomes:
measure: Area Under the Curve from time zero to 24 hours (AUC0-24)
timeFrame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hours post Warfarin dose on Days 0, 11, 22
measure: Area Under the Curve from time zero to infinite (AUC0-infinity)
timeFrame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hours post Warfarin dose on Days 0, 11, 22
measure: Maximum observed plasma concentration (Cmax)
timeFrame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120 and 168 hours post Warfarin dose on days 0, 11, 22
Secondary outcomes:
Other outcomes:
Locations:
city: Lenexa
country: United States
facility: PRA International - Clinical Pharmacology Center
state: Kansas
Study officials:
affiliation: PRA International - Clinical Pharmacology Center
name: Sandra K Willsie, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03344224: Pre-operative Blood Lipid Level and Post-operative Major Adverse Cardiac Event
Official title: The Relationship of Pre-operative Blood Lipid Level and Post-operative Major Adverse Cardiac Event Occurence
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lipid Metabolism Disorders
Postoperative Complications
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2017-11-17
Enrollment: 50000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult non-cardiac surgery patients

Brief summary: Whether the pre-operative blood lipid level and post-operative cardiovascular events is associated is unknown. This study is to find out the main blood lipid and relative protein level change and the post-operative cardiovascular events occurrence.

Detailed description: The participants collected data from their hospital.Patients under going non-cardiac surgery were collected. Data of Triglycerides, cholesterol, Low-density lipoprotein and High-density lipoprotein were collected perioperatively. The postoperative major cardiovascular and cerebral events were also identified and collected. Other data including perioperative information and surgeries and anesthesia data were gathered.

Logistic regression models were built and selected. Independent risk factors relative to postoperative major cardiovascular and cerebral events were screened and identified. different levels of Triglycerides, cholesterol, Low-density lipoprotein and High-density lipoprotein were analysed.

Eligibility criteria: Inclusion Criteria:

* non-cardiac surgery patients with preoperative blood lipid tests

Exclusion Criteria:

* electronic records missing or peri-operative data missing

Primary outcomes:
measure: cardiovascular events
timeFrame: 30 days postoperatively
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Leardi S, Altilia F, Delmonaco S, Cianca G, Pietroletti R, Simi M. [Blood levels of cholesterol and postoperative septic complications]. Ann Ital Chir. 2000 Mar-Apr;71(2):233-7. Italian.
Clinical trial NCT05794724: Intraoperative Frozen Section Pathology to Guide Surgical Treatment for Lung Adenocarcinoma (ECTOP-1016)
Official title: Concordance Between Intraoperative Frozen Section Pathology and Postoperative Paraffin-embedded Pathology in Diagnosing Spread Through Air Space (STAS) of Lung Adenocarcinoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Adenocarcinoma
Surgical Procedure, Unspecified
Pathology
Keywords: Intraoperative frozen section pathology
Surgical treatment
Lung adenocarcinoma
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2023-04-03
Enrollment: 1063
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Clinical stage T1N0M0 lung adenocarcinoma patients who are going to undergo surgical resection.

Brief summary: This study is one of Eastern Cooperative Thoracic Oncology Projects (ECTOP-1016). The goal of this clinical trial is to confirm the concordance rate between intra-operative frozen section pathological diagnosis and post-operative paraffin embedded pathological diagnosis, and use this result to guide surgical treatment for early stage (cT1N0M0) lung adenocarcinomas.


Eligibility criteria: Inclusion Criteria:

* Patients who sign the informed consent form and are willing to complete the study according to the study protocol;
* No previous history of cancer or pulmonary surgery;
* Solitary lesions or multiple lesions with only one not manifesting as pure ground-glass opacity (GGO) on CT scan;
* Peripheral clinical T1N0M0 patients that are eligible for surgery;
* Non-small cell lung cancer is pathologically diagnosed before or at surgery;
* No radiation therapy or chemotherapy before surgery.

Exclusion Criteria:

* Patients with clinical stages other than T1N0M0;
* The lesion cannot be completely resected;
* Previous history of cancer;
* Patients having received radiation therapy or chemotherapy.

Primary outcomes:
measure: Concordance rate
timeFrame: 2 years
Secondary outcomes:
measure: Concordance rate
timeFrame: 2 years
measure: Concordance rate
timeFrame: 2 years
measure: Concordance rate
timeFrame: 2 years
measure: Recurrence-free survival (RFS)
timeFrame: 5 years
measure: Overall survival (OS)
timeFrame: 5 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Cancer Center
state: Shanghai
Study officials:
References:
Clinical trial NCT04498624: Inverted Flap Versus Internal Limiting Membrane Peeling in Small Full Thickness Macular Holes
Official title: Vitrectomy and Inverted Flap or Internal Limiting Membrane Peeling in Small Full Thickness Macular Holes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Full Thickness Macular Hole
Keywords: Full thickness macular hole
Vitrectomy
Inverted flap
Internal limiting membrane peeling
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
First posted: 2020-08-04
Enrollment: 40
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: Primary outcome: difference of microperimetry retinal sensitivity after primary vitrectomy for idiopathic full thickness macular holes with inverted flap technique versus internal limiting membrane (ILM) peeling technique Secondary outcomes: difference of visual change after primary vitrectomy for idiopathic full thickness macular holes with inverted flap technique versus internal limiting membrane (ILM) peeling technique; difference in closure rate after primary vitrectomy for idiopathic full thickness macular holes with inverted flap technique versus internal limiting membrane (ILM) peeling technique


Eligibility criteria: Inclusion Criteria:

* \>18 years old
* idiopathic full thickness macular hole ≤ 350 micron of diameter
* phakic or pseudophakic
* absence of systemic adverse conditions

Exclusion Criteria:

* concomitant retinal and other ocular disease
* previous ocular surgery except cataract surgery
* axial length \>26mm

Primary outcomes:
measure: Microperimetry retinal sensitivity
timeFrame: 3 months
Secondary outcomes:
measure: Best corrected visual acuity (BCVA)
timeFrame: 3 months
measure: Closure rate
timeFrame: 3 months
Other outcomes:
Locations:
city: Torino
country: Italy
facility: A.O.U. Città della Salute e della Scienza di Torino
Study officials:
References:
citation: Ventre L, Fallico M, Longo A, Parisi G, Russo A, Bonfiglio V, Marolo P, Caselgrandi P, Avitabile T, Borrelli E, Reibaldi M. CONVENTIONAL INTERNAL LIMITING MEMBRANE PEELING VERSUS INVERTED FLAP FOR SMALL-TO-MEDIUM IDIOPATHIC MACULAR HOLE: A Randomized Trial. Retina. 2022 Dec 1;42(12):2251-2257. doi: 10.1097/IAE.0000000000003622. Epub 2022 Sep 6.
Clinical trial NCT02024724: Ultrasound Guided Trigeminal Nerve Block for Typical or Atypical Facial Pain
Official title: Phase 4 Study Comparing of Dexamethasone to Triamcinolone for Ultrasound-guided Trigeminal Nerve Block: A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Typical Facial Pain
Atypical Facial Pain
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2013-12-31
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Trigeminal neuralgia is a craniofacial pain syndrome that is typically characterized by unilateral severe, recurrent, electrical pain in one or more distributions of the trigeminal nerve. Current treatment strategies include oral medications as first line therapy with surgical interventions reserved for those patients who are refractory to medications or unable to tolerate medication side effects. Despite these current treatment options, many patients continue to have symptoms. Ultrasound-guided trigeminal nerve block allows for fine adjustment of the needle tip and direct observation of the medicine.

Local anesthetic and steroids have been successfully used for diagnostic and or therapeutic nerve pain with great success. Steroids can be short or long acting in duration with varying side effects. If there exists a difference in duration of action, using the longer acting drug will provide a greater period of symptom relief for the patient and may allow the patient to undergo fewer interventional procedures.


Eligibility criteria: Inclusion Criteria:

* All patients presenting to the Northwestern Pain Center who are eligible and scheduled to receive a ultrasound-guided trigeminal nerve block.

Exclusion Criteria:

* Exclusion is the same for patients who are not eligible for ultrasound guided nerve blocks.

Primary outcomes:
measure: The Proportion of Subjects Reporting at Least 50% Overall Pain Relief
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Anesthesiology Pain Medcine Center
state: Illinois
Study officials:
affiliation: Northwestern University Feinberg School of Medicine
name: Antoun Nader, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01845324: Fetal Heart Interventricular Septum in Fetuses of Diabetic Mothers
Official title: Relation Between Fetal Heart Interventricular Septum Size and Gestational Diabetes Mellitus Control. a Prospective Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pregnancy
Diabetes Mellitus
Keywords: Pregnancy
Diabetes Mellitus
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2013-05-03
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All consequtive pregnant women with Diabetes Mellitus - Gestational and non Gestational

Brief summary: The investigators asume that the measurement of the fetal heart interventricular septum can serve as a good tool to predict glucose control in pregnant patients with diabetes mellitus. The investigators will measure the septum width in patients with Diabetes and will correlate to standard measurements of the glucuse levels.

Detailed description: In this study the investigators will follow patients with Diabetes Mellitus - mainly gestational. the investigators will measure the width of the interventricular septum and correlate with conventional measures of blood glucose measurements in this population.

The investigators will try to assess whether measurement of the septum can be an earlier and better predictor of glucose control in this population.

Eligibility criteria: Inclusion Criteria:

* All consequtive pregnant women
* with Diabetes Mellitus - Gestational and non Gestational

Exclusion Criteria:

.No willing to participate.

* Suspected Heart anomaly

Primary outcomes:
measure: width of fetal interventricula heart septum
timeFrame: 2 years
Secondary outcomes:
measure: glucose control in patients with normal and abnormal interventricular septal width
timeFrame: 2 years
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
affiliation: Hillel Yaffe Medical Center
name: Alon Shrim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03995524: Spasticity and Treatment Satisfaction Among Stroke Survivors
Official title: Perceived Spasticity and Treatment Satisfaction Among Stroke Survivors Over the Course of a Complete Treatment Cycle With Botulinum Neurotoxin A (BoNT-A): an Ethnographic Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spasticity as Sequela of Stroke
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2019-06-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 40 Adults subjects (male or female) suffering from post-stroke spasticity (the US, UK, France, and Italy), who are treated with BoNT-A in the course of routine clinical practice for focal spasticity

Brief summary: To investigate, through ethnography, changes in symptom burden and disability and their effects/interference on patient functioning, ability to perform activities of daily living (ADL) and quality of life (QoL) throughout the duration of one BoNT-A treatment cycle.


Eligibility criteria: Inclusion Criteria:

* Diagnostic of post-stroke spasticity more than three months prior to inclusion
* At least 6 months on treatment (or two treatment cycles) with BoNT-A injections for spasticity according to the decision of the physician
* Previous BoNT-A injection cycles did not last for more than 16 weeks
* Ambulatory (use of walking aids is acceptable)

Exclusion Criteria:

* Neurological disorder other than stroke
* Spasticity-specific treatment changes within 3 months prior to inclusion
* Patients who had undergone neurolysis or surgery to the affected limb within 6 months
* Concurrent participation in a clinical trial for the treatment of spasticity

Primary outcomes:
measure: Degree of functional limitations in daily life activities
timeFrame: monthly for 12 Weeks, or until end of injection cycle whichever occurs first
measure: Health status in subjects with post-stroke spasticity
timeFrame: weekly for 12 Weeks, or until end of injection cycle whichever occurs first
measure: Severity of Pain
timeFrame: 12 weeks
Secondary outcomes:
measure: Burden of spasticity/treatment
timeFrame: Opening interview and ending qualitative interviews, ethnography data which will be provided at discretion of patient/caregiver for 12 weeks or duration of treatment, whichever occurs first, may also support these qualitative analyses
measure: Patients' satisfaction
timeFrame: weekly for 12 weeks or until end of injection cycle whichever occurs first. Opening and closing interview will also explore this
measure: Comparison of feedback between caregivers and stroke survivors
timeFrame: opening ( before week 1) and ending ( 2 weeks after end of injection cycle) qualitative interviews
Other outcomes:
Locations:
city: Paris
country: France
facility: Ipsen Central Contact
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: