louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05284825: A Phase II Trial of Intermediate Radiation Dose For Lymphoma
Official title: A Phase II Trial of Intermediate Radiation Dose For Low Grade Follicular Lymphoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Follicular Lymphoma
Keywords: radiation
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2022-03-17
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the optimal radiation dose fractionation regimen for low grade follicular lymphoma.

It is hypothesized that the complete response rate with the use of 12 Gy in 6 daily fractions is 80% (10% total width of the confidence interval) at 3 months.

This phase II study will evaluate whether an intermediate dose for follicular lymphoma is associated with excellent response rates while minimizing acute and late toxicity.


Eligibility criteria: Inclusion Criteria:

* ≥ 18 years or older
* Pathology review at Sunnybrook Health Sciences Centre showing low grade (grade 1- 2) follicular lymphoma
* Previously un-irradiated stages I-IV low grade follicular lymphoma
* Radiation indicated for local disease control (radical or palliative)
* Able to give informed consent
* Non-bulky targets (less than 7cm)

Exclusion Criteria:

* Systemic therapy (including steroids) for lymphoma within 3 months before or after radiotherapy
* Prognosis less than 3 months
* Pregnancy

Primary outcomes:
measure: Complete response within the radiated volume at 1month post radiation
timeFrame: 1 month
Secondary outcomes:
measure: Overall survival, progression-free survival and toxicity
timeFrame: 1 month and 3 month
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: May Tsao, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00695825: Effects the Glycemic Index on Metabolic Risk Markers
Official title: Postprandial Effects of a Low vs. a High Glycemic Index Food Product on Metabolic Risk Markers in Lean and Obese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome X
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2008-06-12
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Recent population studies have shown that the glycemic index (GI) of food products is positively associated with the risk of developing type 2 diabetes and cardiovascular disease (CVD). In the pathogenesis of type 2 diabetes and CVD, inflammatory processes play a pivotal role. In a previous intervention study (11 weeks), however, we found no effects of lower-GI vs. higher-GI diets on fasting inflammatory markers in subjects with increased risk of developing the metabolic syndrome. People, however, spent most of their time in the postprandial period. Therefore, there is a need to study the postprandial effects of low-GI vs. high-GI diets. In addition, it needs to be emphasized the GI is derived from studies in lean subjects, while especially overweight and obese people suffer from metabolic aberrations related to the development of type 2 diabetes and CVD. AIM: To investigate in obese subjects the postprandial effects of a low-GI vs. high-GI food product on metabolic risk markers. A second research objective is to compare these effects with those in lean subjects.


Eligibility criteria: Inclusion Criteria:

* healthy and obese men

Exclusion Criteria:

* smoking

Primary outcomes:
measure: inflammation markers
timeFrame: postprandial effect
Secondary outcomes:
measure: glucose response
timeFrame: postprandial
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: University Maastricht
Study officials:
affiliation: Maastricht University
name: Ruth Vrolix, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03888625: Compare the Healing Process of Idiopathic Macular Hole With Different Surgical Techniques
Official title: Randomized Clinical Trials to Compare the Healing Process of Idiopathic Macular Hole With Different Surgical Techniques
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Macular Holes
Keywords: macular holes
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2019-03-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In Group A, patients will undergo peeling with complete removal of the internal limiting membrane (ILM) and in the group B, the inverted ILM peeling technique will be performed.
Primary purpose: TREATMENT

Brief summary: To compare anatomic and functional results, and to evaluate postoperatively the healing process in 2 different techniques for the closure of the macular holes (MH)

Detailed description: Patients with macular holes classified in stages 3 and 4 will be randomized into 2 groups. . In Group A, patients will undergo peeling with complete removal of the internal limiting membrane (ILM) and in the group B, the inverted ILM peeling technique will be performed. The 20% sulfur hexafluoride (SF6) gas will be used as a tamponade agent in all surgeries, and patients will be instructed to avoid the prone position for 5 days.

OCT images will be performed in the first 5 postoperative days and months 1, 3 and 6.

The primary outcome is anatomic closure of the MH closure in the month 6. The second outcomes are: mean best corrected visual acuity (BCVA) at month 6, mean change in the BCVA at month 6; integrity of the perifoveal external limiting membrane and ellipsoid zone on Optical Coherence Tomography (OCT); MH closure rate over time in days; functional improvement of microperimetry Statistical analysis will be performed with Student t-test and the p-value of ≤ 0.05 is considered significant.

Eligibility criteria: Inclusion Criteria:

\> Stage 3 and 4 macular holes with visual acuity between 20/30 and 20/800 according to the ETDRS chart.

Exclusion Criteria:

* Macular holes secondary to ocular trauma, myopia or retinal detachment
* Any previous treatment for the macular hole
* Evidence on examination of any diabetic retinopathy
* History or presence of wet or dry age macular degeneration (AMD)
* Presence of epiretinal membrane or prior uveitis
* Any ocular surgery within 3 months before baseline
* Intra or periocular infection

Primary outcomes:
measure: Rate of Anatomic closure
timeFrame: Month 6 post operative
Secondary outcomes:
measure: BCVA mean
timeFrame: Month 6 post operative
measure: BCVA change
timeFrame: Screening and Month 6 post operative
measure: Integrity Membrane measured in microns (μm) by OCT
timeFrame: Month 6 post operative
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Dept. of Ophthalmology
Study officials:
affiliation: Federal University of São Paulo
name: Mauricio Maia, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02198625: Influence of Moderate Inspired Oxygen Fraction (FiO2) and Protective Ventilation on Postoperative Pulmonary Complication
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hepatectomy
Keywords: Moderate FiO2
Protective lung ventilation
Postoperative pulmonary complications
Positive end-expiratory pressure
recruitment maneuvers
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2014-07-23
Enrollment: 280
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the influence of moderate FiO2 and the lung protective ventilation on postoperative pulmonary complications following hepatic resection surgery.


Eligibility criteria: Inclusion Criteria:

* ASA 1\~2,Planned intrabdominal hepatic resection surgery;
* Expected duration 2 hours to 6 hours;
* Age 40 yr to 70 yr);
* BMI 18-26.9kg/m2
* Risk of postoperative pulmonary complications (Arozullah score ≥2);

Exclusion Criteria:

* Noninvasive ventilation in the last 30 days;
* Recent history of pneumonia, ALI/ARDS (in the last 30 days);
* History of pulmonary resection;
* History of neuromuscular disease;
* Child-Pugh\>A grade；
* Patient refusal;

Primary outcomes:
measure: a composite of pulmonary and extrapulmonary complications occurring by day 7 after surgery.
timeFrame: during the first seven days after surgery
Secondary outcomes:
measure: incidence of pulmonary complications
timeFrame: within the 30-day follow-up period
measure: Oxidative stress markers
timeFrame: 2 days
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: First Affiliated Hospital, Sun Yat-Sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT01282125: Nasal Obstruction in Sleep Apnea Patients Compared to the General Population
Official title: A Comparative Study of Nasal Obstruction in a Sleep Apnea Population Compared to the General Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnoea Syndrome
Nasal Obstruction
Keywords: general population
prevalence
Norway
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Sorlandet Hospital HF
First posted: 2011-01-24
Enrollment: 217
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients: St Olavs Hospital, Trondheim, Norway Controls: Community sample, residents of Trøndelag, Norway

Brief summary: Recent clinical findings of research at Trondheim University Hospital suggest that surgical correction of the nose septum in addition to volume reduction of the nose cavity may be beneficial in patients who suffer from both nose obstruction and obstructive sleep apnea syndrome(data not yet published).

This study aims to compare nose obstruction prevalence in sleep apnea patients and the general population


Eligibility criteria: Inclusion Criteria:

* ???

Exclusion Criteria:

* ???

Primary outcomes:
measure: patient reported nasal obstruction
timeFrame: 1 week
measure: objective nasal obstruction
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St Olavs Hospital Trondheim University Hospital
Study officials:
affiliation: Aleris/NTNU
name: Ståle S. Nordgård, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moxness MH, Bugten V, Thorstensen WM, Nordgard S, Bruskeland G. A comparison of minimal cross sectional areas, nasal volumes and peak nasal inspiratory flow between patients with obstructive sleep apnea and healthy controls. Rhinology. 2016 Dec 1;54(4):342-347. doi: 10.4193/Rhino16.085.
Clinical trial NCT02625025: Low vs Standard Pneumoperitoneum Pressure During Single Port Access Laparoscopic for Adnexal Pathology
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Adnexal Benign Pathology
Lead sponsor: University of Cagliari
Sponsor class: OTHER
First posted: 2015-12-09
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: During laparoscopy pneumoperitoneum creates the necessary space in which to perform the operation. Growing evidence in general surgery has shown that reduction of intra-abdominal pressure during laparoscopy is related to improved postoperative outcomes, decreased pain perception, length of hospital stay, and analgesic rescue dosage in patients undergoing minimally invasive procedures using low pneumoperitoneum pressure (LPP) compared with standard pneumoperitoneum pressure (SPP). Aim of the study is to demonstrate the safety and feasibility of LPP during performance of Single Port Access Laparoscopy for benign adnexal pathologies.


Eligibility criteria: Inclusion Criteria:

* patients 18- 45 years old
* elective laparoscopic operation
* informed consent

Exclusion Criteria:

* BMI \> 30 kg/cm2
* pregnancy
* converting to laparotomy
* malignant disease
* unable or unwilling to give written consent

Primary outcomes:
measure: Postoperative pain measured on a VAS scale
timeFrame: 6 hours
Secondary outcomes:
measure: Operation time
timeFrame: 0 hours after the operation
measure: Blood loss in ml
timeFrame: 0 hours after the operation
measure: Complications
timeFrame: Two months
measure: Shoulder tip pain measured on a VAS scale
timeFrame: 24 hours
measure: Postoperative pain measured on a VAS scale
timeFrame: 24 hours
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00697125: Immunogenicity & Reactogenicity of Various Formulations of Recombinant Hepatitis B Vaccine With Different Adjuvants
Official title: Study to Evaluate the Immunogenicity and Reactogenicity of Various Formulations of GSK Biologicals' (Previously SmithKline Beecham Biologicals') Recombinant Hepatitis B Vaccine With Different Adjuvants in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis B
Keywords: Hepatitis B
Engerix™-B
Recombinant hepatitis B vaccine
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-06-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the immunogenicity and reactogenicity of various formulations of recombinant hepatitis B vaccine with different adjuvants in healthy adult volunteers following the 0, 1, 6 months schedule

Detailed description: At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham

Eligibility criteria: Inclusion Criteria:

* Between 18 and 40 years old.
* Written informed consent will have been obtained from the subjects.
* Good physical condition as established by physical examination and history taking at the time of entry.
* Female participants will avoid becoming pregnant during the study period and they will have been on a contraceptive program for at least 2 months before entry

Exclusion Criteria:

* Pregnancy or lactation.
* Serological signs of HBV infection
* Elevated serum liver enzymes
* Any vaccination against hepatitis B in the past.
* Any previous administration of MPL.
* History of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease.
* Axillary temperature \> 37.5°C at the time of injection.
* Any acute disease at the moment of entry.
* Chronic alcohol consumption.
* Any treatment with immunosuppressive or immunostimulant therapy.
* Any chronic drug treatment, which in the investigator's opinion, precludes inclusion into the study.
* History of allergic disease likely to be stimulated by any component of the vaccine.
* Administration of any other vaccine(s) or any immunoglobulin during the study period.
* Simultaneous participation in any other clinical trial.

Primary outcomes:
measure: Occurrence and intensity of solicited local and general symptoms
timeFrame: 8 days follow-up after vaccination
Secondary outcomes:
measure: Anti-HBs antibody concentrations
timeFrame: Months 0, 1, 3, 6, 7, 8 and 12
measure: Occurrence, intensity of unsolicited adverse events
timeFrame: 30-day follow-up after vaccination
measure: Occurrence of serious adverse events
timeFrame: During the study period up to 30 days after last vaccination
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: GSK Clinical Trials Call Center
Study officials:
affiliation: GlaxoSmithKline
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT04227925: The Longevity of Trichuris Trichiura Colonization
Official title: The Longevity of Trichuris Trichiura Colonization
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Helminthiasis
Helminth Infection
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2020-01-14
Enrollment: 1
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A singlex healthy volunteer

Brief summary: The aim of the study was to study the longevity of Trichuris trichiura colonization

Detailed description: The present study investigates the longevity of Trichuris trichiura colonization in a human volunteer as measured by regular fecal sampling.

Eligibility criteria: Inclusion Criteria:

The included volunteer is a researcher within parasitology with focus on Trichuris trichiura and Trichiura suis. He planned to infect himself under medical supervision. This was his third self-infection with Trichuris. The only clinical criterion for his inclusion in the study was that he was healthy.

Exclusion Criteria:

N/A

Primary outcomes:
measure: Faecal egg excretion
timeFrame: 78 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00663325: Safety Dermatological Evaluation: Acceptability With Gynecological Follow up - Dermacyd Tina Gel Sweet Flower
Official title: Monocentric Study, Phase III, for Safety Dermatological Evaluation: Acceptability With Gynecological Follow up - Dermacyd Tina Gel Tangerina Mix
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hygiene
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-04-22
Enrollment: 30
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to demonstrate the safety of the gynecological formulation in normal and usual usage condition of Dermacyd Tina Gel Sweet Flower.


Eligibility criteria: Inclusion Criteria:

* Integral skin test in the region;

Exclusion Criteria:

* Lactation or gestational risk or gestation;
* Use of Anti-inflammatory or immunosuppression drugs 1 month before the study;
* Topical medication use at the region to be treated;
* Cutaneous disease or active gynecological disease which may interfere in study results;
* Personal history of allergic disease at the area to be treated;
* Allergic or atopic history;

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Adverse events and their intensity and their association with the treatment
timeFrame: 21 days
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Sanofi-aventis
Study officials:
affiliation: Sanofi-aventis administrative office Brazil
name: Jaderson Lima
role: STUDY_DIRECTOR
References:
Clinical trial NCT05196425: Expression of PARP-1 in Multiple Sclerosis Patients
Official title: Expression of PARP-1 in Optic Neuritis of Multiple Sclerosis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Optic neuritis-Multiple sclerosis-PARP-1
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-01-19
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study will explore the expression of PARP-1 in optic neuritis of multiple sclerosis patients.

The data will be collected from Sohag University hospital in the period from the start of August 2021 to the end of December 2021.

The study protocol will be approved by the Scientific Research Ethical Committee, Faculty of Medicine, Sohag University.


Eligibility criteria: Inclusion Criteria:

* Patients with multiple sclerosis with or without optic neuritis Multiple sclerosis will be diagnosed according to the McDonald criteria

Exclusion Criteria:

* • Isolated optic neuritis.

Primary outcomes:
measure: measure PARP-1 mRNA
timeFrame: 2 weeks
Secondary outcomes:
measure: Optic nerve, RNFL and GCC layer affection by MS
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Elshimaa A.Mateen
Study officials:
References:
Clinical trial NCT02090725: Controlled Trial of 3,4-Diaminopyridine (3-4DAP) in Lambert-Eaton Myasthenic Syndrome (LEMS)
Official title: Controlled Trial of 3,4-Diaminopyridine in LEMS
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Muscle Weakness
Keywords: fluctuating muscle weakness
hyporeflexia
autonomic Dysfunction
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: Jacobus Pharmaceutical
First posted: 2014-03-18
Enrollment: 4
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main purpose for this study is to provide access to 3,4 DAP, a drug which has demonstrated to be effective in treating weakness associated with Lambert-Eaton Myasthenic Syndrome. LEMS is a rare autoimmune cause of a defect in neuromuscular transmission. The disorder is clinically characterized by fluctuating muscle weakness, hyporeflexia and autonomic dysfunction.

Detailed description: More than half of LEMS cases are associated with malignancy, usually small cell lung cancer. These paraneoplastic cases progress more quickly than primary autoimmune LEMS. An overlap syndrome with other autoimmune diseases is often detected in LEMS patients.

3,4 DAP is effective in LEMS because it increases calcium influx into the nerve terminal by blocking potassium efflux and thereby prolonging the presynaptic action potential. 3,4 DAP is less likely to provoke epileptic seizures than its precursor, 4-aminopyridine, because it is less able to cross the blood-brain barrier. 3,4 DAP is effective in increasing strength and improving autonomic symptoms in LEMS patients of both the primary autoimmune and paraneoplastic etiologies.

Eligibility criteria: Inclusion Criteria: -Male or female majority between 45 and 60 years of age

* diagnosed with Lambert-Eaton Myasthenic Syndrome.
* subjects must be taking full dose of pyridostigmine

Exclusion Criteria: - does subject have a history of liver problems?

* does subject have a history of prolonged QTc syndrome (which is a condition where there is prolongation between the start of the Q wave and the end of the T wave in the heart's electrical cycle).

Primary outcomes:
measure: Number of Participants That Showed Improvement in Muscle Weakness During Their Last Study Related Visit
timeFrame: Participants were followed until they withdrew or the study ended. Time frame ranged from 1 month to 3 years.
Secondary outcomes:
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Jeffrey A. Cohen, MD
role: PRINCIPAL_INVESTIGATOR
References: