louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04732364: Analgesic Efficacy of Ultrasound Guided Erector Spinae Block for Modified Radical Mastectomy
Official title: Analgesic Efficacy of Magnesium Sulphate as an Adjuvant to Levo-bupivacine in Ultrasound Guided Erector Spinae Plan Block for Modified Radical Mastectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Pain, Postoperative
Keywords: Erector Spinae Block
magnesium sulphate
dexmedetomidine
Lead sponsor: South Egypt Cancer Institute
Sponsor class: OTHER
First posted: 2021-02-01
Enrollment: 60
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To compare the analgesic efficacy of dexmedetomidine and magnesium sulphate as adjuvants to levobupivacaine in erector spinae plane block in modified radical mastectomy surgery for acute and chronic pain management.

Detailed description: 3 groups.

Group (C) / (I):20 patient (control group) :

Patients will receive 20 ml 0.25% levobupivacaine into the interfascial plane below erector spinae muscle at level of T5.

Group (D)/ (II) :20 patient (Dexmetonidine group) :

Patient will receive 20ml 0.25% levobupivacaineas above + 1μ/kg dexmedetomidine.

Group (M) / (III) : 20 patient (magnesium slphate group) :

Patient will receive 20ml 0.25% levobupivacaineas above + 0.7 mg/kg MgSo4 . The patient, the anesthesiologist who administered the drugs, and the data collector will be blinded to the study drugs.

Eligibility criteria: Inclusion Criteria:

* female patient
* American society of anesthesiologists (ASA) I and II physical status
* age from 25 to 70 years old
* scheduled for either left or right modified radical mastectomy (MRM).

Exclusion Criteria:

* infection of the skin at or near site of needle puncture
* coagulopathy
* drug hypersensitivity or allergy to the studied drugs
* central or peripheral neuropathy
* significant organ dysfunction cardiac dysrrhythmias
* obesity (BMI\>35kg/m2)
* recently use analgesic drugs

Primary outcomes:
measure: analgesia requirement
timeFrame: 24 hours
Secondary outcomes:
measure: chronic pain assessment
timeFrame: 6 months
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: South Egypt Cancer Institute
Study officials:
affiliation: specialist
name: peter R Edward, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01772264: Safety And Tolerability Study Of BID Titration Scheme With PF-05089771
Official title: An Investigator And Subject Blinded, Sponsor Open, Randomized, Placebo Controlled, Multiple Dose Study To Investigate The Safety, Toleration And Pharmacokinetics Of Multiple Oral Doses Of PF-05089771 In Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-01-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The most notable tolerability finding from these multiple dosing studies has been the occurrence of mild to moderate rash at doses of 450 mg BID and 600 mg BID. Based upon this finding, the current four week study is designed to examine whether a slow titration regimen up to a lower maintenance dose of 450 mg BID is able to reduce the incidence of rash.


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects of non-child bearing potential between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal (ie, recurrent nephrolitisis), endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* History of, or presence of allergic skin reactions or active skin disease (except for subjects with acne who may be included in the study) at the time of screening.

Primary outcomes:
measure: Percentage of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs)
timeFrame: 28 days
measure: Area Under the Curve from Time Zero to end of dosing interval (AUCtau)
timeFrame: 12h
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 12h
Secondary outcomes:
measure: Minimum Observed Plasma Trough Concentration (Cmin)
timeFrame: 12h post dose
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04425421: Recommendations for the Treatment of Children With Burkitt's Lymphoma
Official title: Recommendations for the Treatment of Children With Burkitt's Lymphoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Burkitt Lymphoma
Lead sponsor: French Africa Pediatric Oncology Group
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 1000
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All Children with a Burkitt's Lymhoma.

Brief summary: This is the 4th LMB study by the French African Pediatric Oncology Group (GFAOP). The study hopes to be able to evaluate children earlier with stage I and II disease and to evaluate treatment response earlier so that the units can decide if a change in treatment is necessary, it is also hoped to provide an intensification of treatment for the stage IV disease.

Detailed description: This is the 4th Burkitt's Lymphoma (LMB) study by the GFAOP group. This study hopes to include at least 14 Sub Saharian countries some of whom have never participated in a LMB study. The evaluation of improvement in early diagnosis should be possible in this study. The study hopes to be able to evaluate children earlier, with stage I and II disease and to evaluate treatment response earlier so that the units can decide if a change in treatment is necessary, it is also hoped to provide an intensification of treatment for children with a stage IV disease.

Eligibility criteria: Inclusion Criteria:

Clinical diagnosis of Burkitt's Lymphoma: all location. Diagnosis by cytology or histology. Not possible to follow all the treatment.

-

Exclusion Criteria:

Not a B Cell tumor. Child has been previously treated. Child has also another illness which would render the treatment incompatible. Parents refusal.

Primary outcomes:
measure: Evaluation of the number of cases with local disease.
timeFrame: 5 years
measure: Evaluation of the number of cases by stage at the time of diagnosis.
timeFrame: 5 Years
measure: Evaluating the treatment given.
timeFrame: 5 Years
measure: Evaluating the follow up after treatment.
timeFrame: 5 Years
measure: Number of relapse cases
timeFrame: 5 years
Secondary outcomes:
measure: Application of therapeutic recommendations
timeFrame: 5 years
Other outcomes:
Locations:
city: Ouagadougou
country: Burkina Faso
facility: Hopital Yalgado Ouedraogo
city: Kinshasa
country: Congo, The Democratic Republic of the
facility: Cliniques Universitaires de Kinshasa
city: Lubumbashi
country: Congo, The Democratic Republic of the
facility: Cliniques Universitaires de Lubumbashi (CUL)
city: Abidjan
country: Côte D'Ivoire
facility: CHU de Treichville à ABIDJAN
city: Antananarivo
country: Madagascar
facility: HJRA, Hôpital universitaire Joseph Ravoahangy Andrianavalona
city: Bamako
country: Mali
facility: CHU Gabriel Touré (HGT)
city: Dakar
country: Senegal
facility: Hôpital Aristide Le Dantec
Study officials:
References:
Clinical trial NCT06010121: Comparison of Bioavailability of Liposomal and Traditional Formulation of Vitamin D3
Official title: Comparison of Bioavailability of Liposomal and Traditional Formulation of Vitamin D3
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bioavailability of Vitamin D
Keywords: Liposovit-D
Vitamin D
Cholecalciferol
Lead sponsor: AronPharma Sp. z o. o.
Sponsor class: INDUSTRY
First posted: 2023-08-24
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The aim of the study was to compare the profiles of 25-hydroxyvitamin D serum concentration in healthy adults after 4 weeks of using vitamin D supplementation either in a liposomal or a traditional formulation.

Detailed description: The study will be randomized, cross-over, participants will be randomly assigned to one of the study groups: A) the group receiving vitamin D3 in traditional formulation B) the group receiving vitamin D3 in liposomal formulation. The day before the start of supplementation (T0), 2 weeks (T1) and 4 weeks (T2) after the start of supplementation, participants will have their blood drawn. Then, after a wash-out period of 2 months, the groups will be switched. Participants will again receive daily supplementation with vitamin D3 for 4 weeks. Blood will be drawn before the start of supplementation (T0), 2 weeks (T1) and 4 weeks (T2) after the start of supplementation.

Eligibility criteria: Inclusion Criteria:

* Women and men, 18-60 years old.
* Signed informed consent.
* No injuries or hospitalizations within the last 3 months.
* No vitamin D supplementation for the 2 months prior to the study initiation.
* Refraining for the period of the clinical trial from consuming foods additionally fortified with vitamin D and dietary supplements containing vitamin D
* Refraining for the period of the clinical trial from the use of cosmetic therapies that use prolonged body illumination

Exclusion Criteria:

* Unwilling to give consent
* Injuries within the last 3 months
* Obesity, BMI above 30
* Bariatric surgery
* Cystic fibrosis, celiac disease, Crohn's disease
* Metabolic diseases
* Drugs reducing cholesterol absorption, thiazide diuretics, glucocorticosteroids, anticonvulsants, calcium-containing preparations,
* Planned prolonged exposure to sunlight during the study period

Primary outcomes:
measure: Level of 25-hydroxycholecalciferol
timeFrame: Baseline, 2 weeks, 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Gdańsk
country: Poland
facility: Gdański Uniwersytet Medyczny
Study officials:
References:
Clinical trial NCT06565221: Microvascular Blood Flow During Passive Heating
Official title: Microvascular Blood Flow During Passive Heating
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Blood Flow
Lead sponsor: San Diego State University
Sponsor class: OTHER
First posted: 2024-08-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Determine whether passive heating intervention effects microvascular blood flow as measured with near-infrared spectroscopy


Eligibility criteria: Inclusion Criteria:

* between 18 and 50 years

Exclusion Criteria:

* Diagnosis of peripheral neuropathy
* open wounds on feet

Primary outcomes:
measure: Microvascular blood flow volume
timeFrame: Baseline and during intervention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03736564: Ga-DOTATATE PET for Phosphaturic Mesenchymal Tumors in Patients With Tumor Induced Osteomalacia
Official title: 68Ga-DOTATATE PET for Localization of Phosphaturic Mesenchymal Tumors in Patients With Tumor Induced Osteomalacia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Osteomalacia
Keywords: FGF 23
oncogenic
tumor induced
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2018-11-09
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The researchers are trying to evaluate a newer imaging technique (Ga-DOTATATE PET/CT) to see if it is more sensitive to localize the source of the hormone, which has caused the low phosphate levels.

Detailed description: Subjects will be contacted (phone script attached) to inform them of the study and the imaging modality. The first 10 patients that agree to participate in the study will be asked to present to the Mayo Clinic where they can provide a written consent and perform the imaging study.

Enrolled subjects will be evaluated in the clinical practice prior to having 68Ga-DOTATATE PET/CT imaging performed. The treating endocrinologist will be informed of the imaging results and will review the results with the subject using a follow-up visit or phone call; when a tumor is localized, the endocrinologist will discuss appropriate management options.

Subjects will be follow for one year post 68Ga-DOTATATE PET/CT.

Eligibility criteria: Inclusion Criteria:

* Adults (18 years of age or older) seen at Mayo Clinic, Rochester for FGF23 mediated osteomalacia between 1/1/2000 and 1/30/2018 who provide informed consent to participate in the study.

Exclusion Criteria:

* Pregnant
* Prisoners
* Subjects diagnosed with heritable hypophosphatemic rickets/osteomalacia
* Subjects who do not consent for the study or withdraw consent during the duration of the study.
* Subjects in whom tumor localization and successful resection has already occurred.

Primary outcomes:
measure: Number of Participants With Positive Localization of Phosphaturic Mesenchymal Tumors (PMTs)
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Matthew Drake, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Stephen M Broski, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00626964: Prevention of Coronary Heart Disease in Morbidly Obese Patients
Official title: Prevention of Coronary Heart Disease in Morbidly Obese Patients. Lifestyle Intervention, Low Energy Diet or Bariatric Surgery.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Morbid Obesity
Hypertension
Type 2 DM
Obstructive Sleep Apnea
Osteoarthrosis
Keywords: Arterial stiffness
PulseWave velocity
Body composition
Bioimpedance
Morbid Obesity
APO A
APO B
Framingham risk score
Prevention of Coronary Heart Disease
Lifestyle Intervention
Bariatric Surgery
Low Energy Diet
Lead sponsor: The Hospital of Vestfold
Sponsor class: OTHER
Collaborators: name: Oslo University Hospital
First posted: 2008-02-29
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Morbidly Obese patients with BMI \> 40, or BMI \> 35 with comorbidity such as Hypertension, Obstructive Sleep Apnea, Weight Related Osteoarthrosis, Type 2 DM.

Brief summary: The changes in risks of developing coronary heart disease in patients with morbid obesity after different weight loss interventions have not been extensively studied. The primary objective of this study is to investigate whether an intensive lifestyle intervention program in a tertiary care clinic (Spesialsykehuset for Rehabilitering) is comparable with a 7-week low-energy-diet followed by bariatric surgery in decreasing the risk of cardiovascular disease in these patients.

Detailed description: Patients matching the eligibility criteria were divided into two groups (not randomized). One group underwent a 7 weeks Low-Energy-Diet before bariatric surgery, the other group participated in an intensive lifestyle intervention program for 3 months.

Data on arterial stiffness, body weight, body composition, blood pressure, blood samples, vital parameters are registered in the both groups at baseline, 7 weeks and after 1 year.

Eligibility criteria: Inclusion Criteria:

* Morbidly Obese patients with BMI \> 40, or BMI \> 35 with comorbidity such as Hypertension, Obstructive Sleep Apnea, Weight Related Osteoarthrosis, Type 2 DM.

Exclusion Criteria:

* Participation in other weight loss program the last 12 months. Serious psychiatric conditions

Primary outcomes:
measure: Arterial stiffness
timeFrame: 7 weeks and 1 year
measure: Cardiovascular risk factors
timeFrame: 7 weeks and 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Tønsberg
country: Norway
facility: Morbid Obesity Center, Vestfold Hospital Trust
Study officials:
affiliation: Morbid Obesity Center, Vestfold Hospital Trust
name: Jøran Hjelmesæth
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nordstrand N, Gjevestad E, Dinh KN, Hofso D, Roislien J, Saltvedt E, Os I, Hjelmesaeth J. The relationship between various measures of obesity and arterial stiffness in morbidly obese patients. BMC Cardiovasc Disord. 2011 Feb 1;11:7. doi: 10.1186/1471-2261-11-7.
Clinical trial NCT02536664: Non-Interventional Study to Examine Rituximab Treatment in Follicular Lymphoma Participants
Official title: RIM - Rituximab in Maintenance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Follicular Lymphoma
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-09-01
Enrollment: 505
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: Participants with follicular lymphoma who are to be treated with Rituximab in the maintenance dosing period as decided by the physician

Brief summary: It is a non-interventional study with a duration of approximately 24 months per participant to investigate the therapeutic efficiency, safety and treatment regimens of Rituximab maintenance therapy in daily routine in participants with previously untreated, relapsed or refractory cluster of differentiation 20 (CD20)-positive follicular lymphoma (FL) in clinical practice.


Eligibility criteria: Inclusion Criteria:

* Age over 18 years
* Previously untreated, relapsed or refractory CD 20-positive FL
* Responding to rituximab containing induction therapy (complete response \[CR\] or partial response \[PR\])
* To receive rituximab maintenance therapy (decision taken by doctor prior to and independent of this non-interventional study)
* No ineligibility for rituximab

Exclusion Criteria:

Not Applicable (NA)

Primary outcomes:
measure: Percentage of Participants Who Were Alive and Free From Progressive Disease
timeFrame: 2 years
Secondary outcomes:
measure: Median Progression Free Survival (PFS) Time
timeFrame: 2 years
measure: Percentage of Participants Who Were Alive
timeFrame: 2 years
measure: Median Overall Survival (OS) Time
timeFrame: 2 years
measure: Percentage of Participants With Response (Complete Response [CR], Partial Response [PR], Stable Disease [SD] or Progressive Disease [PD] at the End of Maintenance Therapy
timeFrame: 2 years
measure: Percentage of Participants With Best Overall Response
timeFrame: 2 years
measure: Percentage of Participants With Initiation of New Therapy
timeFrame: 2 years
Other outcomes:
Locations:
city: Essen
country: Germany
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT05677464: Prospective Multicenter Study With the Endomina® Triangulation Platform
Official title: Prospective Multicenter Study to Assess the Safety and Efficacy of the Endomina® Triangulation Platform for Treating Patients Requiring Endoscopic Gastroplasty
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obesity
Keywords: Obesity
Gastroplasty
Endoscopic gastroplasty
endomina
Lead sponsor: Endo Tools Therapeutics S.A.
Sponsor class: INDUSTRY
First posted: 2023-01-10
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients, who require endoscopic gastroplasty (ESG) and who are selected by multidisciplinary team/investigators to be treated with the endomina® device.

Brief summary: This registry is designed to further assess on a larger scale safety and efficacy of the endomina® device and tissue apposition accessories (TAPES) when used in the frame of "real life" routine clinical practice

Detailed description: This is a single arm prospective, multi-center international, open-label, non-interventional, , post-market study. This registry is designed to further assess on a larger scale safety and efficacy of the endomina® and TAPES devices. Patients in need of endoscopic gastroplasty will be enrolled and followed-up for 36 months following hospital routine practice.

Eligibility criteria: Inclusion Criteria:

* Patient must be willing to provide written informed consent
* Adult patients (between ≥ 18 years (legal age in Europe) and 65 years of age at time of ESG)
* Patients who require endoscopic gastroplasty and who are selected by multidisciplinary team/investigators to be treated with the endomina® device and accessories according to the Instructions for Use (IFU)

Exclusion Criteria:

* Patients with impaired hemostasis or pre-existing conditions that may lead to fragile mucosa (i.e., any contraindication to suturing the stomach)
* Any malformation from mouth to esophagus (including pharynx)
* Any contraindication to general anesthesia, including patients with cardiorespiratory dysfunction or respiratory failure
* Woman who are pregnant, at the time of the procedure or planning (trying) to become pregnant, or nursing within 12 months after the procedure.
* Impending surgery 60 days post intervention of the treated section of the GI tract
* Participation in another clinical study evaluating another medical device, another procedure or a medication that did not reach its primary endpoint

Primary outcomes:
measure: Safety outcome
timeFrame: 12 months
measure: Technical success
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Gosselies
country: Belgium
facility: Endo Tools Therapeutics S.A.
state: Wallonie
Study officials:
affiliation: Endo Tools Therapeutics S.A.
name: Mrs Leclercq
role: STUDY_DIRECTOR
References: