louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04553744: Identification of Surgical Management of Lymph Node Basins and Surgical Practice Patterns Among Sarcoma Surgeons
Official title: Survey of Extremity and Trunk Sarcoma Surgeons Regarding Surgical Management of Lymph Node Basins
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Soft Tissue Sarcoma
Lymph Node Cancer
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-09-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Practicing surgeons who are members of The Society of Surgical Oncology and Musculoskeletal Tumor Society, and treat extremity and trunk soft tissue sarcomas.

Brief summary: This study investigates the surgical management of lymph node basins for extremity and trunk soft tissue sarcoma (ETSTS) to identify and better understand the surgical practice patterns of sarcoma surgeons. ETSTS has been known to spread to distant locations including lymph nodes, with some subtypes of the disease spreading to lymph nodes more than others. This has led to sarcoma surgeons to treat patients differently from one another, including those with more lymph node involvement. The purpose of this study is to investigate the practice patterns of ETSTS surgeons.

Detailed description: PRIMARY OBJECTIVES:

I. Identify the practice patterns of sarcoma surgeons with respect to management of lymph node basins for extremity and trunk soft tissue sarcomas (ETSTS).

II. Identify when surgeons would perform sentinel lymph node biopsy and/or lymph node dissection for ETSTS and if management differs for high-risk subtypes of sarcoma that are more likely to have nodal metastases.

III. Identify differences in practice patterns between surgical oncologists and orthopedic oncologic surgeons.

OUTLINE:

Participants complete an online survey over 5-10 minutes asking how they would manage lymph node basins in the extremity sarcoma.

Eligibility criteria: Inclusion Criteria:

* Currently practicing surgeons who treat ETSTS and are members of The Society of Surgical Oncology and Musculoskeletal Tumor Society

Exclusion Criteria:

None

Primary outcomes:
measure: Practice patterns of sarcoma surgeons
timeFrame: Up to 2 years
measure: Sentinel lymph node biopsy and/or lymph node dissection for ETSTS
timeFrame: Up to 2 years
measure: Differences in practice patterns
timeFrame: Up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Christina L Roland
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03164044: Improved Basophil Activation Test (BAT) in the Diagnostics of Drug Allergy
Official title: Improved Basophil Activation Test (BAT) in the Diagnostics of IgE-mediated Drug Allergy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Drug Allergy
Antibiotic Allergy
NSAID-Induced Anaphylactoid Reaction
Keywords: Allergy
Drug allergy
Basophil activation test
Flow cytometry
Lead sponsor: The Republican Research and Practical Center for Epidemiology and Microbiology
Sponsor class: OTHER
First posted: 2017-05-23
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with the suspected allergy to antibiotics or NSAIDs

Brief summary: Current study evaluates the use of the improved Basophil Activation Test (BAT) in the diagnostics of IgE-mediated allergy to antibiotics and non-steroidal anti-inflammatory drugs (NSAIDs).

Detailed description: Current study evaluates the use of the improved Basophil Activation Test (BAT) in the diagnostics of IgE-mediated allergy to antibiotics and non-steroidal anti-inflammatory drugs (NSAIDs). Among commonly used CD63/CD203c markers, newly proposed molecules, such as CD69, CD107a, CD164, CD13, CD11b and CD300a will be assayed. Results obtained together with the other clinical data will be used to calculate sensitivity and specificity of the method.

Eligibility criteria: Inclusion Criteria:

* suspected allergy to antibiotics or NSAIDs in the last 1 year.

Exclusion Criteria:

* autoimmune diseases;
* HIV;
* hepatitis B/C;
* other acute or chronic infectious diseases;
* malignant neoplasms;
* leukemia;
* other severe acute or chronic intercurrent diseases;
* pregnancy/lactation;
* refuse of patient to participate in the trial.

Primary outcomes:
measure: Sensitivity of the improved Basophil Activation Test (BAT) in the Diagnostics of Drug Allergy
timeFrame: 1 month
measure: Specificity of the improved Basophil Activation Test (BAT) in the Diagnostics of Drug Allergy
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Minsk
country: Belarus
facility: Andrei Hancharou
Study officials:
affiliation: Laboratory for Immunology and Cellular Biotechnology, The Republican Research and Practical Center for Epidemiology and Microbiology
name: Andrei Hancharou, Dr
role: STUDY_DIRECTOR
affiliation: Laboratory for Immunology and Cellular Biotechnology, The Republican Research and Practical Center for Epidemiology and Microbiology
name: Iryna U Ramanava
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06706492: Muscle Oxygenation, Functional Capacity and Frailty in Kidney Transplant Recipients with and Without Inspiratory Muscle Weakness
Official title: Comparison of Muscle Oxygenation, Functional Capacity, and Frailty in Kidney Transplant Recipients with and Without Inspiratory Muscle Weakness
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Renal Transplantation
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2024-11-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Kidney transplant recipients will be included.

Brief summary: The aim of this study was to compare respiratory function, muscle oxygenation, functional capacity, peripheral muscle strength, body composition, and frailty in kidney transplant recipients with and without inspiratory muscle weakness.


Eligibility criteria: Inclusion Criteria:

* Patients with kidney transplantation
* At least 6 months after the kidney transplant
* Not having regular exercise habits
* Voluntary participation in the study

Exclusion Criteria:

* Having a musculoskeletal problem that may interfere with the tests
* Having neurological impairment
* Having chronic lung disease
* Having had any cardiovascular event in the last 6 months

Primary outcomes:
measure: Respiratory muscle strength
timeFrame: 1st day
measure: Respiratory muscle strength
timeFrame: 1st day
measure: Functional capacity
timeFrame: 1st day
measure: Peripheral muscle strength
timeFrame: 1st day
measure: Peripheral muscle strength
timeFrame: 1st day
Secondary outcomes:
measure: Forced expiratory volume in one second
timeFrame: 1st day
measure: Forced vital capacity
timeFrame: 1st day
measure: Forced expiratory volume in one second/forced vital capacity
timeFrame: 1st day
measure: Peak expiratory flow
timeFrame: 1st day
measure: Forced mid-expiratory flow
timeFrame: 1st day
measure: Body composition
timeFrame: 1st day
measure: Fragility
timeFrame: 1st day
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
References:
Clinical trial NCT03709992: Trospium Chloride vs Tamsulosin in Treatment of Ureteral Stent Related Symptoms:
Official title: Trospium Chloride vs Tamsulosin in Treatment of Ureteral Stent Related Symptoms: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Ureter Stone
Quality of Life
Ureter Obstruction
Keywords: ureteral stent
USSQ
Tamsulosin
Trospium Chloride
Lead sponsor: Mansoura University
Sponsor class: OTHER
Collaborators: name: Amiri Hospital
First posted: 2018-10-17
Enrollment: 200
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will be conducted to compare the efficacy and safety of Trospium chloride versus Tamsulosin for treatment of ureteral stent related symptoms.

Detailed description: Eligible patients will be randomized to one of the two treatment groups. Group 1 patients will receive 30 mg of Trospium chloride tablet twice daily, while group 2 patients will receive 0.4 mg of Tamsulosin tablet once daily, until the stent is removed. Ureteral Stent Symptoms Questionnaire (USSQ) will be used to evaluate the symptoms of the patients with DJ stent after 2 weeks of inserting the stent.

Eligibility criteria: Inclusion Criteria:

* Patients with double "J" (DJ) stent after ureteroscopy or for drainage of obstructed kidney

Exclusion Criteria:

1. Patients with hypersensitivity to either Trospium chloride or Tamsulosin
2. Patients with complications after DJ insertion (such as fever, hematuria, perforation, stent migration).
3. Patients receiving alpha blockers or anticholinergic medications for any other reason.
4. Patients with history of orthostatic hypotension.
5. Pregnant or breastfeeding females.
6. Patients with hepatic impairment (Child-Pugh score \>9).
7. Patients with severe renal impairment with creatinine clearance of less than 15 mL/min.
8. Patients with narrow-angle glaucoma.
9. Patients with history of urinary retention or gastric retention.

Primary outcomes:
measure: Ureteral Stent Symptoms Questionnaire (USSQ) score
timeFrame: 14 days
Secondary outcomes:
measure: Adverse events
timeFrame: 14 days
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Ahmed R EL-Nahas
state: Kuwait
Study officials:
affiliation: Amiri Hospital - Kuwait
name: Abdullatif AL-Terki, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06048692: Cefepime and Unictam on Preventing Post-Cesarean Surgical Site Infections
Official title: The Impact of Cefepime and Unictam on Preventing Post-Cesarean Surgical Site Infections
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Cesarean Section; Infection
Keywords: surgical site infection
Cefepime
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 213
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: the aim of this study is to evaluate the efficacy of employing cefepime (CFM) versus ampicillin/sulbactam (AMS) in lowering the rate of post-cesarean surgical site infections.

Detailed description: A prospective randomized clinical study conducted in the department of obstetrics and gynecology of Beni-Suef University Hospital . A total of 213 women were assessed for eligibility, 13 of which were excluded. A total of 200 pregnant women who were eligible for elective cesarean sections (CS). The overall median duration of postoperative followed up was from 10 days to one month to determine the surgical site infection (SSI).

Eligibility criteria: Inclusion Criteria:

* Pregnant women within age group more than18 years.
* Pregnant women with elective cesarean delivery.
* Previous and primary cesarean delivery.

Exclusion Criteria:

Severe hepatic disease women Emergent cesarean deliveries. Women with medical disorders as pre-gestational diabetes, anemia, hypertension, or preeclampsia.

Women who had a skin infection adjacent to the operative site.

Primary outcomes:
measure: surgical site infection
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Banī Suwayf
country: Egypt
facility: Beni-suef university Hospital
state: Beni Suef
Study officials:
affiliation: Faculty of Medicine Beni-Suef University
name: Beni-Suef University
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03557892: Sensor-augmented Pump Versus Multiple Daily Injections With Degludec as Basal Insulin for Insulin Therapy in Type 1 Diabetes
Official title: Continuous Subcutaneous Insulin Infusion Associated With Continuous Glucose Monitoring in Comparison With Subcutaneous Multi-injection Insulin Therapy Using Degludec as Basal Insulin: a Randomized Crossover Trial in Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: Azienda Ospedaliero-Universitaria Careggi
Sponsor class: OTHER
First posted: 2018-06-15
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Several studies have shown that Continuous Subcutaneous Insulin Infusion together with Continuous Glucose Monitoring improves glycemic control in type 1 diabetes when compared to more traditional approaches; however, in available trials the basal insulin used in multi-injection therapy is typically glargine, which is associated with a higher hypoglycemic risk than degludec.

This study will assess the efficacy and safety of Continuous Subcutaneous Insulin infusion (CSII) combined with Continuous Glucose Monitoring (CGM), as compared to Multiple Daily Injections (MDI) of insulin analogues, using degludec as basal insulin, associated with traditional self-monitoring of capillary blood glucose (SMBG) in patients with type 1 diabetes. A crossover design was chosen in order to minimize study sample improving statistical power.


Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes
* Duration of diabetes \> 2 years
* Current treatment with MDI, using insulin analogues as bolus and basal insulin
* HbA1c\<64 mmol/mol

Exclusion Criteria:

* HbA1c\>64 mmol/mol
* Pregnancy or lactation

Primary outcomes:
measure: HbA1c
timeFrame: 4 months
Secondary outcomes:
measure: Severe Hypoglycemia
timeFrame: 4 months
measure: Local Reactions
timeFrame: 4 months
Other outcomes:
Locations:
city: Firenze
country: Italy
facility: Diabetologia AOU Careggi
Study officials:
References:
Clinical trial NCT00848692: Drug Intervention in Chronic Fatigue Syndrome
Official title: B-cell Depletion Using the Monoclonal Anti-CD20 Antibody Rituximab in Chronic Fatigue Syndrome. A Double-blind, Placebo-controlled Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Chronic Fatigue Syndrome
Keywords: Chronic Fatigue Syndrome
CFS
Myalgic Encephalomyelitis
Rituximab
B-lymphocyte depletion
B-cell depletion
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
First posted: 2009-02-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Based on pilot patient observations,the investigators anticipate that chronic fatigue syndrome (CFS) patients may benefit from B-cell depletion therapy.

The hypothesis is that at least a subset of CFS patients have an activated immune system involving B-lymphocytes, and that B-cell depletion may alleviate symptoms.


Eligibility criteria: Inclusion Criteria:

* verified chronic fatigue syndrome (CDC-criteria)
* age \>18 and \<60 years
* informed consent

Exclusion Criteria:

* pregnancy or lactation
* previous malignant disease except basal cell carcinoma of skin and cervical carcinoma in situ
* previous long-term use of immunosuppressive drugs
* previous exposure to rituximab
* endogenous depression
* multi-allergy with risk of serious drug reaction
* reduced renal function (creatinin \> 1.2 x UNL)
* reduced liver function (bilirubin or transaminases \> 1.5 x UNL)
* known HIV infection
* signs of active viral infection by pretreatment investigations

Primary outcomes:
measure: Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes.
timeFrame: 3 months after intervention
Secondary outcomes:
measure: Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes
timeFrame: 2, 4, 6, 8, 10, 12 months after intervention
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Department of Oncology and Medical Physics, Haukeland University Hospital
Study officials:
affiliation: Department of Oncology and Medical Physics, Haukeland University Hospital
name: Olav Mella, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fluge O, Bruland O, Risa K, Storstein A, Kristoffersen EK, Sapkota D, Naess H, Dahl O, Nyland H, Mella O. Benefit from B-lymphocyte depletion using the anti-CD20 antibody rituximab in chronic fatigue syndrome. A double-blind and placebo-controlled study. PLoS One. 2011;6(10):e26358. doi: 10.1371/journal.pone.0026358. Epub 2011 Oct 19.
Clinical trial NCT03663192: Strain Echocardiography During Septic Shock : an Observational Pilot Study
Official title: Strain Echocardiography During Septic Shock : an Observational Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Shock, Septic
Echocardiography
Keywords: Shock, Septic
Echocardiography
speckle tracking
strain
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2018-09-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ICU patients

Brief summary: The mortality of septic shock remains high nowadays despite a trend toward improvement.Septic cardiomyopathy has been reported in most experimental models of sepsis shock. Its relationship with mortality is unclear. A decrease in mortality have been reported in patients with decreased left ventricular ejection fraction (LVEF), but a recent meta-analysis did not support such results. In fact, it appears that high LVEF are linked to profound vasoplegia which is associated to bad outcome.

In the other hand, alterations of Strain echocardiography, a new method allowing a more sensitive evaluation of heart function, have been associated with a worse outcome in sepsis patients. Only few studies have examined echocardiographic strain during sepsis shock in human, and its natural history was only described in pigs. Moreover, the right ventricular strain was reported only by Orde et al whereas the evolution of strain during fluid infusion have never been studied. The aim of the present study is to describe the natural history of echocardiographic strain during sepsis shock and to determine its prognosis value.


Eligibility criteria: Inclusion Criteria:

* Septic shock (suspected or proven infection and norepinephrine ≥ 0,25µg/kg/min)
* Inclusion within the first 24h of septic shock

Exclusion Criteria:

* Patient \< 18 year of age
* Pregnant women
* History of myocardial infarction, valvular disease, atrial fibrillation

Primary outcomes:
measure: Global peak systolic longitudinal strain assessed by echocardiography. Global peak systolic longitudinal strain
timeFrame: up to 90 days
Secondary outcomes:
measure: ICU mortality
timeFrame: up to 90 days
Other outcomes:
Locations:
city: Nîmes
country: France
facility: Intensive care unit CHU Nimes
Study officials:
affiliation: CHU Nimes
name: Claire Roger, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03633292: Aloe Vera and Chlorhexidine Against Traumatic Oral Ulcers
Official title: Aloe Vera and Chlorhexidine as Preventive Oral Antiseptics Against the Appearance of Traumatic Oral Ulcers in Patients With Fixed Orthodontics: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Oral Ulcer
Lead sponsor: University of Santiago de Compostela
Sponsor class: OTHER
Collaborators: name: Alfonso X El Sabio University
First posted: 2018-08-16
Enrollment: 140
Sex: ALL
Minimum age (years): 11
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The development of gingivitis in patients during orthodontic treatment is widely known, with the characteristic response of gingival inflammation and hyperplasia and traumatic rashes or ulcerations of the oral mucosa derived from the treatment. The use of chemical agents such as CHX, although it has proven to be useful in these patients, but has the disadvantage of having side effects such as staining, even restricting its use during treatment.

The objective of this study was to determine the efficacy of Aloe vera gel at 80% compared to 0.12% Chlorhexidine gel to alleviate the effects derived from any orthodontic treatment, such as gingival inflammation and hyperplasia and friction or ulcerations. of traumatic oral mucosa-derived from treatment in patients after cementation with metal brackets in the two arches. A total of 140 patients between the ages of 10 and 55 who were randomized and assigned in the two study groups treated with Aloe vera gel versus the conventional Chlorhexidine gel with a sample of 70 subjects in each group participated.

The index of gingival inflammation, plaque index, as well as the simplified hemorrhage index, were evaluated.


Eligibility criteria: Inclusion Criteria:

* Patients who have just begun orthodontic treatment after bracket cementation.
* Be willing and have signed the informed consent.
* Presence of cemented metal brackets throughout the upper and lower arches.
* Presence of good oral health: dental, periodontal and soft tissue

Exclusion Criteria:

* Allergic or who have suffered adverse reactions to Chlorhexidine or Aloe Vera.
* Pregnant, since they are not claimants of fixed multibrackets appliances.
* Presence of auxiliary extraoral appliances during the treatment that may cause additional injuries.
* Under 11 years old.

Primary outcomes:
measure: Prevalence of traumatic oral ulcers
timeFrame: 30 days
Secondary outcomes:
measure: Prevalence of gingival inflammation
timeFrame: 30 days
measure: Prevalence of gingival bleeding
timeFrame: 30 days
Other outcomes:
measure: Security and tolerability - number of participants with treatment related adverse events as assessed by CTCAE v4.0
timeFrame: 30 days
Locations:
city: Santiago De Compostela
country: Spain
facility: Mario Pérez Sayáns
state: A Coruña
Study officials:
References: