louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03606785: Evaluation of the Efficacy and Safety of Single Dose Tranexamic Acid in Reducing Blood Loss During Colorectal Cancer Surgery
Official title: Evaluation of the Efficacy and Safety of Single Dose Tranexamic Acid in Reducing Blood Loss During Colorectal Cancer Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Colorectal Surgery
Keywords: colorectal,blood, transfusion,haemorrhage,tranexamic acid.
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-07-31
Enrollment: 46
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: A total of 46 patients scheduled for explorative laparotomy with the aim of radical debulking surgery for colorectal cancer will be randomized into two equal groups one will receive tranexamic acid and one placebo.

The TA group will receive an intravenous bolus of (10 mg/kg) in 100 ml of normal saline over 20 minutes after induction of anesthesia and before surgical incision. In the control group, patients will receive a placebo of 100 mL 0.9% normal saline. The primary endpoint is reduction in blood loss, while the secondary endpoint was the number of patients needing transfusion and occurrence of postoperative thrombotic complications (myocardial infarction, stroke, pulmonary embolism, renal failure, or bowel infarction) within 30 days after surgery.


Eligibility criteria: Inclusion criteria

* ASA 1 and ASA 2 patients scheduled for colorectal cancer surgery.
* Age above 18 years \& less than 65 years.

Exclusion criteria:

* Thrombophilia or any bleeding disorder.
* Previous or active thromboembolic disease.
* Family history of thromboembolism.
* Known Allergy to TA.
* Liver dysfunction.
* Preexisting renal dysfunction (serum creatinine \>1.2 mg/dL).
* Coronary stent insertion within a year prior to operation.
* Cardiovascular problem (e.g., myocardial infarction, atrial fibrillation, angina, heart failure),
* Lifelong warfarin therapy for thromboembolism prophylaxis.

Primary outcomes:
measure: reduction in blood loss
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: NCI, Cairo university
Study officials:
References:
Clinical trial NCT05164185: The Effect of Remote Ischemic Conditioning in Patients With Hypercholesterolemia
Official title: The Effect of Remote Ischemic Conditioning in Patients With Hypercholesterolemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypercholesteremia
Endothelial Dysfunction
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2021-12-20
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: There is an on-going discussion weather remote ischemic conditioning (RIC) is effective in limiting the damage of reperfusion injury in STEMI patients. The results from recent RCTs have been variable and most have not shown convincing positive results when analyzing hard endpoints. Hence, there is a great need to evaluate the impact of comorbidities on the effectiveness of RIC. Therefore, we have designed a study to evaluate the impact of hypercholesterolemia on the RIC response by evaluating ischemia-induced endothelial dysfunction.

Aim: To investigate the impact of hypercholesterolemia on the RIC response in counteracting ischemia-induced endothelial dysfunction.

Detailed description: Study population:

We plan to include 12 poorly controlled/newly diagnosed subjects with familiar hypercholesterolemia (FH) and 12 age-matched control subjects.

Inclusion criteria (FH subjects)

* Poorly treated FH, defined as LDL-C \>5.5 mmol/L.
* Age, \>18 and \<65 years of age.

Exclusion criteria

* Additional cardiovascular comorbidities such as diabetes mellitus, coronary artery disease, or kidney failure.
* Unwillingness to participate.
* Concurrently participating in another interventional trial.

Main exposure:

Remote ischemic conditioning, i.e. 4 cycles of 5 minutes of ischemia to the lower limb.

Comparision group:

Cross over design, patients preform the protocol twice, once with sham and once with RIC. Also a group of healthy matched controls will be recruited.

Outcome:

Change in FMD after 20 minutes of ischemia and 20 minutes of reperfusion with the exposure of either sham or RIC.

Design:

Randomized interventional cross-over.

Eligibility criteria: Inclusion Criteria:

* Poorly treated FH, defined as LDL-C \>5.5 mmol/L.
* Age, \>18 and \<65 years of age.
* A age matched control-group.

Exclusion Criteria:

* Additional cardiovascular comorbidities such as diabetes mellitus, coronary artery disease, or kidney failure.
* Any condition which interfere with the outcome recording for example atrial fibrillation.
* Unwillingness to participate.
* Concurrently participating in another interventional trial.

Primary outcomes:
measure: Flow-mediated vasodilatation/endothelium-dependent vasodilatation
timeFrame: 20 min post-reperfusion
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet, Karolinska University Hospital
Study officials:
affiliation: Karolinska Institutet
name: John Pernow, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02640885: The Foley's Catheter Balloon to the Bleeding From Placenta Previa
Official title: Use of Foley's Catheter Balloon Tamponade to Control Placental Site Bleeding Resulting From Placenta Previa During Cesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Hemorrhage
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2015-12-29
Enrollment: 15
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Post-partum haemorrhage due to placenta previa is usually from the placental bed at the lower uterine segment and it occurs after the placenta separation. Although, nowadays the obstetrician can diagnose placenta previa before delivery, it is still one of the important causes of maternal mortality . Hysterectomy can be the only effective action to take, although it carries many morbidities for the women especially those with low parity.

Uterine packing considers as a line of treatment before performing surgical procedures in postpartum hemorrhage resulting from placental site bleeding. It can save life, avoid laparotomy and save uterus.

Nowadays, the use of intrauterine balloons have been developed and become effective for the control of placental site bleeding not responding to medical treatment. The 2-way Foley's Cather has many advantages over the gauze packing; First, it allows drainage of blood so no occult bleeding could be accumulated inside the uterus as in uterine gauze, second the removal of the Foley's Cather balloon is easy and not a painful, third, the removal of 2-way Foley's Cather could be gradually as a test of its effectiveness before complete removal .


Eligibility criteria: Inclusion Criteria:

* Patients with placenta previa
* Delivered by cesarean section

Exclusion Criteria:

* Patients with sever uncontrolled uterine bleeding after delivery
* Placenta accreta

Primary outcomes:
measure: Amount of blood loss (mL)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university
Study officials:
References:
Clinical trial NCT05441085: Programed Intermittent Epidural Bolus Interval 90 (EI90) of 10 ml, 0.0625% Bupivacaine Plus 2 μg/mL Fentanyl
Official title: Programmed Intermittent Epidural Bolus Interval 90 Min of 10ml,0.0625% Bupivacaine Plus 2μg/mL Fentanyl in Nulliparous Versus Multiparous Parturient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labour Pain
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2022-07-01
Enrollment: 30
Sex: FEMALE
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Multiple studies showed the numerous advantages of implementing programmed epidural bolus (PIEB) technique, where a fixed volume of local anesthetic is automatically administrated at a set time interval compared to the continuous epidural infusion technique (CEI). The advantages were improved maternal satisfaction, decreased local anesthetic consumption, and decreased second stage of labor.The theory behind PIEB is that to attain a more uniform spread of local anesthetic in the epidural space a higher volume of injectate and a higher pressure is needed.Different approaches using different timings and volumes for PIEB have been proposed to achieve the optimal regimen. Many studies showed evidence that 10 mL boluses of bupivacaine 0.0625% with fentanyl 2 μg/mL delivered every 40 min, named effective programed intermittent epidural bolus interval 90 (EI90), produced effective analgesia without breakthrough pain in 90% of nulliparous women during the first stage of labor.


Eligibility criteria: Inclusion Criteria:

* Patients of ASA physical status 2-3 with a singleton pregnancy
* gestational age \> 37 weeks
* regular uterine contractions occurring at least every 5 min;
* cervical dilation 2-5 cm
* pain \> 5 (Visual analogue score (VAS) 0-10) at the time of request for epidural analgesia .

Exclusion Criteria:

* Refusal to concent
* Contraindication to epidural analgesia as allergy or hypersensitivity to bupivacaine or fentanyl
* Patients who had opioids or sedatives within 4 h preceding epidural insertion.
* Unintentional dural puncture.
* Patient who deliver within 1 h after initiation of epidural clinician bolus.
* The inability to achieve as VAS score ≤2 after the initial loading dose will be considered as a failure and will be excluded from the study.

Primary outcomes:
measure: adequate labour analgesia
timeFrame: six hours
Secondary outcomes:
measure: Upper sensory block
timeFrame: 24hours
measure: Visual Analogue Scale to pain
timeFrame: 24 hours
measure: Motor block
timeFrame: 24 hours
measure: Total anaesthetic volume
timeFrame: 24 hours
measure: Side effects
timeFrame: 24 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine Menoufia University
state: Governorate
city: Cairo
country: Egypt
facility: Rabab Habeeb
state: Governorate
Study officials:
References:
Clinical trial NCT06318585: Creation of a Clinical Database for the Study of Phenotypic Variability in Motor Neuron Diseases
Official title: Creazione di un Database Clinico Per lo Studio Della variabilità Fenotipica Nella Malattia Del Motoneurone
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Amyotrophic Lateral Sclerosis
Motor Neuron Disease
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
First posted: 2024-03-19
Enrollment: 200
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: Consecutive cohort of patients from a tertiary Italian ALS Centre

Brief summary: Study Description: Characterization of Motor Neuron Disease Phenotypes

The goal of this observational study is to understand the clinical presentation of motor neuron disease (MND) in patients attending the Neurology Department of the Istituto Auxologico Italiano. The main questions it aims to answer are:

* What are the specific clinical phenotypes associated with MND?
* How can these phenotypes contribute to a better understanding of the disease's underlying mechanisms and improve prognostic accuracy?

Participants will undergo:

* Clinical evaluation using validated scales
* Neurophysiological and neuroradiological instrumental assessment
* Neuropsychological evaluation
* Collection of biological materials for genetic screening and biomarker assessment, if necessary.


Eligibility criteria: Inclusion Criteria:

* diagnosis of ALS or other motor neuron disease

Exclusion Criteria:

* refusal to participate to the study

Primary outcomes:
measure: no. of patients with classic ALS
timeFrame: baseline (at diagnosis), at 1 year
measure: no. of patients with bulbar ALS
timeFrame: baseline (at diagnosis), at 1 year
measure: no. of patients with LMN phenotypes (flail arm, flail leg, PMA)
timeFrame: baseline (at diagnosis), at 1 year
measure: no. of patients with UMN phenotypes (pyramidal ALS, PLS)
timeFrame: baseline (at diagnosis), at 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Ospedale San Luca
state: MI
Study officials:
References:
Clinical trial NCT06631885: Efficacy of Integrated Nano-technology in Revascularization of Immature Necrotic Teeth
Official title: Efficacy of Integrated Nano-technology in the Irrigation Protocol of Revascularization Technique In Immature Necrotic Teeth (Randomized Clinical Trial)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Immature Teeth
Necrotic Pulp
Keywords: regenerative endodontic procedure
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial aims to study the effect of photoactivated disinfection using Diod laser (810 nm) to activate photosensitive nanoparticle chitosan as an endodontic irrigant versus sodium hypochlorite followed by saline and then EDTA 17% on 1) postoperative pain and 2) the success of revascularization in patients with necrotic immature maxillary anterior teeth using a randomized clinical trial design.

Detailed description: randomized clinical trial will be conducted to investigate and compare the efficacy of photosensitized nano-chitosan 2% as an endodontic disinfectant during revascularization versus sodium hypochlorite, followed by EDTA 17% according to the standardized protocol of the American Association of endodontics.

Twenty individuals with necrotic, immature permanent anterior teeth will be recruited. They will be randomly assigned into two groups according to the received intervention: control group and test group.

pain will be evaluated as a primary outcome at 24 hours and one week post-intervention using numerical rating scale (NRS). In addition, the root development in terms of change in root length and apical foramen diameter and periapical bone healing will be evaluated as secondary outcomes using cone beam tomography.

Eligibility criteria: Inclusion Criteria:

* o Immature necrotic maxillary incisor with open apex greater than 1 mm.

  * Teeth where pulp space are not needed for post and core.
  * A restorable tooth.
  * Patients should be free from any systemic disease that may affect normal healing and predictable outcome.
  * Patients who will agree to the consent and will commit to follow-up period.

Exclusion Criteria:

* o Non-restorable teeth.

  * Teeth with root fractures, internal or external root resorption.
  * Teeth with mature fully developed root with closed apex
  * Patients with any systemic disease that may affect predictable outcome

Primary outcomes:
measure: pain intensity assessed by numerical rating scale
timeFrame: 24 hours and 1 week after completion of the procedure
Secondary outcomes:
measure: root development
timeFrame: 6 months, 1 year postoperative
measure: Apical foramen closure
timeFrame: 6 months, 1 year postoperative
measure: periapical bone healing
timeFrame: 6 months, 1 year postoperative
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04390685: Prevention of Breast Cancer-related Lymphedma With Tacrolimus
Official title: Prevention of Breast Cancer-related Lymphedma With Tacrolimus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Lymphedema
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2020-05-15
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Breast cancer-related lymphedema is one of the most common and feared consequences of breast cancer treatment. Tacrolimus ointment may prevent lymphedema by inhibition of CD4+T cells.


Eligibility criteria: Inclusion Criteria:

* Female
* Breast cancer with planned ALND
* postmenopausal or use of contraceptives
* good general health condition
* read and understand Danish

Exclusion Criteria:

* Pregnant, breastfeeding it wishing to conceive with the next year
* bilateral breast cancer
* known allergy to tacrolimus or macrolides
* known lymphedema
* other malignant disease apart from keratinocyte cancer
* in medical treatment for diabetes mellitus
* known psychiatric condition which may influence participation
* known renal or hepatic function

Primary outcomes:
measure: Lymphedema
timeFrame: 1 year
Secondary outcomes:
measure: Subjective changes assessed using the LYMPH-ICF (Lymphoedema Functioning, Disability and Health) questionaire
timeFrame: 1 year
measure: Subjective changes assessed using DASH (DISABILITIES OF THE ARM, SHOULDER AND HAND) questionaire
timeFrame: 1 year
measure: Subjective changes assessed using SF-36 questionnaire (Short form-36)
timeFrame: 1 year
measure: Change in L-DEX score using bioimpedance (Odense University Hospital Only).
timeFrame: 1 year
measure: Change in lymph drainage. (Odense University Hospital Only).
timeFrame: 1 year
Other outcomes:
Locations:
city: Esbjerg
country: Denmark
facility: Sydvestjysk Sygehus
city: Odense
country: Denmark
facility: Department of Plastic and Reconstructive Surgery
city: Vejle
country: Denmark
facility: Sygehus Lillebælt Vejle
Study officials:
References:
Clinical trial NCT06387485: A Study to Evaluate the Utilization of 3D Printed Models in Pre-Operative Planning
Official title: A Study to Evaluate the Utilization of 3D Printed Models in Pre-Operative Planning
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sarcoma, Ewing
Chondrosarcoma
Osteosarcoma
Fibrous Histiocytoma
Fibrosarcoma
Keywords: bony tumor
Lead sponsor: Ricoh USA, Inc.
Sponsor class: INDUSTRY
First posted: 2024-04-29
Enrollment: 150
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This prospective, multi-center, randomized controlled study aims to assess the efficacy of utilizing 3D printed models in preoperative planning for the excision of tumors involving bony structures within the body. The study is expected to last approximately 12 months and involve up to 150 subjects across 3 sites. Subjects will be randomized in a 1:1 ratio into either the experimental arm, utilizing 3D printed models and imaging, or the active comparator arm, using only imaging.

Primary endpoint: Operative time of surgical procedure.

Secondary endpoints: Reduction of blood loss, proportion of postoperative adverse events, and negative tumor margins.

Exploratory endpoints: Surgical planning ease, changes in surgical plan, and surgeon satisfaction.


Eligibility criteria: Inclusion Criteria:

1. Subjects must be at least 22 years of age.
2. Subjects must have the ability to provide written informed consent.
3. Subjects must have tumor(s) invading bone and requiring surgical excision including but not limited to craniomaxillofacial, spine, long bone, and pelvis.
4. Subjects must be willing to have quality cross-sectional imaging that will allow for use to develop a 3D printed model.

Exclusion Criteria:

1. Pregnant or nursing women.
2. Subjects that have a serious systemic pathology.
3. Subjects that have clotting disorders.
4. Subjects that have uncontrolled hypertension.
5. Subjects that are HIV-positive.
6. Subjects that are unable to be randomized; i.e surgical team prefers to use either 3D model or standard cross-sectional imaging for surgical pre-planning.
7. Subject anatomy has changed substantially since the date medical imaging from which the model is derived was obtained (as applicable).
8. Subject is a poor surgical or poor study candidate which may include, any medical, social or psychological problem that could complicate the procedure.

Primary outcomes:
measure: Operative time
timeFrame: Incision to closure
Secondary outcomes:
measure: Blood loss
timeFrame: Incision to closure
measure: Adverse Events
timeFrame: Surgery to 90 days post-surgery
measure: Tumor margin status
timeFrame: Post-surgery (+3 days)
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: William Beaumont University Hospital
state: Michigan
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
Study officials:
References:
Clinical trial NCT00196885: Effect of an Antioxidant on Cancer-Cachectic Patients Undergoing Exercise Training
Official title: Effect of N-Acetylcysteine on Skeletal Muscle in Cachectic Cancer Patients Undergoing a Resistance Training Program (Phase 2 Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastrointestinal Neoplasms
Bronchial Carcinoma
Hodgkin Disease
Non-Hodgkin Lymphoma
Weight Loss
Keywords: cancer cachexia
muscle wasting
weight loss
proteolysis
Lead sponsor: German Cancer Research Center
Sponsor class: OTHER
Collaborators: name: Heidelberg University
First posted: 2005-09-20
Enrollment: 60
Sex: ALL
Minimum age (years): 20
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 the study is to tests the hypothesis, that N-acetylcysteine (a thiol-antioxidant)improves the exercise training effect on cancer patients that experience weight loss (cachexia) as assessed by muscle mass and function as well as histomorphology.


Eligibility criteria: Inclusion Criteria:

* gastrointestinal or bronchial cancer
* weight loss of 10% within 6 months
* sufficient mobility

Exclusion Criteria:

* severe pain, steroid therapy, severe internal, muscular, neurological, psychiatric disease, N-acetylcysteine allergy

Primary outcomes:
measure: muscle cross-sectional area, peak forces
Secondary outcomes:
measure: muscle fiber composition (biopsy vastus lateralis muscle mRNA levels of cytokines, myostatin. Activity of Akt-dependent pathways
measure: muscle 31Phospho-magnetic-resonance spectroscopy
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: German Cancer Research Center, D020
state: Baden-Württemberg
Study officials:
affiliation: German Cancer Research Center
name: Wulf Hildebrandt, MD
role: STUDY_DIRECTOR
References:
citation: Hauer K, Hildebrandt W, Sehl Y, Edler L, Oster P, Droge W. Improvement in muscular performance and decrease in tumor necrosis factor level in old age after antioxidant treatment. J Mol Med (Berl). 2003 Feb;81(2):118-25. doi: 10.1007/s00109-002-0406-7. Epub 2003 Feb 8.