louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01809119: Prospective Randomized Study Comparing Laparoscopic Versus Open Partial Nephrectomy
Official title: Prospective Randomized Study Comparing Laparoscopic Versus Open Partial Nephrectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Kidney Neoplasms
Keywords: Kidney Neoplasms, Minimally invasive surgery, Renal cell carcinoma
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2013-03-12
Enrollment: 242
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Partial nephrectomy is considered the standard treatment for renal tumors smaller than 7 cm. With the evolution of image diagnostic tools and dissemination of its use, smaller tumors are being commonly diagnosed and treated. The partial open nephrectomy is still considered the gold standard technique for nephron sparing surgery, especially when the surgeon is not experienced with the minimally invasive surgery. In the last 15 years, uncountable minimally invasive techniques were developed, including the laparoscopic partial nephrectomy. The objective of this study is compare the partial laparoscopic nephrectomy to open partial nephrectomy in terms of perioperative, oncologic and functional outcomes. A balanced randomized prospective trial will be conducted. One group of patients will be submitted to to open partial nephrectomy while the other group of patients will be submitted to laparoscopic partial nephrectomy. A randomized prospective trial comparing the two techniques is necessary to determine the differences in outcomes between them and if the laparoscopic partial nephrectomy can be performed without harms to the patients.


Eligibility criteria: Inclusion Criteria:

* Patients with renal tumor cT1N0M0; (\<7 cm)
* Normal renal function (serum creatinine \<1.2 and glomerular filtration rate\> 60mL/min/1.73m2)
* Tumor only

Exclusion Criteria:

* Functional or anatomical solitary kidney
* Horseshoe kidney, ectopic or malformed
* Clinical contraindication to surgery
* Contraindication to laparoscopic surgery
* Association with other renal pathologies
* Evidence of lymph node or systemic disease in preoperative staging

Primary outcomes:
measure: Surgical Complications
timeFrame: 6 months
Secondary outcomes:
measure: Renal Function
timeFrame: 2 years
measure: Oncological outcomes
timeFrame: 5 years
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Cancer Institute of the State of São Paulo
Study officials:
affiliation: Cancer Institute of the State of São Paulo - University of Sao Paulo
name: Marcos F Dall'Oglio, M.D., Associate Professor
role: STUDY_DIRECTOR
affiliation: Cancer Institute of the State of São Paulo - University of Sao Paulo
name: Giuliano B Guglielmetti, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Cancer Institute of the State of São Paulo - University of Sao Paulo
name: Alexandre C Sant'Anna, Doctor
role: STUDY_CHAIR
References:
Clinical trial NCT06448819: Real-life Use of the Crohn's Disease Exclusion Diet (CDED) in Adult Patients With Crohn's Disease
Official title: Real-life Use of the Crohn's Disease Exclusion Diet (CDED) in Adult Patients With Mild-to-moderate Crohn's Disease Activity: an Open Label, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Crohn Disease
Lead sponsor: Universita degli Studi di Genova
Sponsor class: OTHER
First posted: 2024-06-07
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study explores the effectiveness od the Crohn's Disease Exclusion Diet (CDED) as a tretament for adults with mild-to-moderate Crohn's disease (CD). The hypotesis is that CDED, by excluding specific dietary components thought to exacerbate gut inflammation, can induce remission in CD patients more effectively than a control diet based on the Mediterranean pattern. Conducted as an open-label randomized trial, the research aim to provide real-world evidence of CDED's safety and its inpact on clinical remission, body composition and overall quality of life for CD patients.


Eligibility criteria: Inclusion Criteria:

* mild-to-moderate Crohn's disease activity (HBI between 5 and 16)

Exclusion Criteria:

* concomitant treatment with corticosteroids, antibiotic therapies and nutraceutical supplements, treatment with biological drugs and traditional immunosuppressants started less than 24 weeks before enrollment, presence of active fistulas or abscesses, gastrointestinal tract surgery less than 6 months to randomization, coeliac disease, type 1 diabetes mellitus, uncontrolled type 2 diabetes mellitus, acute coronary disease (unstable angina, myocardial infarction), advanced acute or chronic liver disease, congestive heart failure (NYHA class III-IV), acute and chronic nephropathies (GRF\<30 ml/min according to the CKD-EPI formula), presence of acute infectious diseases and pregnancy.

Primary outcomes:
measure: Harvey-Bradshaw Index (HBI
timeFrame: 12 weeks; 24 weeks
Secondary outcomes:
measure: Fecal calprotectin
timeFrame: 12 weeks; 24 weeks
Other outcomes:
Locations:
city: Genova
country: Italy
facility: Giorgia Bodini
Study officials:
References:
Clinical trial NCT05858619: Molecular Signatures of Cutaneous Dupilumab Response
Official title: Molecular Signatures of Cutaneous Dupilumab Response
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Atopic Dermatitis
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2023-05-15
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study examines the effect of IL4RA blockade with dupilumab on the immune cells of atopic dermatitis skin lesions.

Detailed description: This is a one-arm, open-label study to examine the effect of dupilumab. Dupilumab is a FDA-approved medication for the treatment of atopic dermatitis. This study will examine how dupilumab affects immune cells within atopic dermatitis skin lesions. Fifteen subjects with moderate to severe atopic dermatitis will be enrolled. Biopsy samples will be collected and undergo molecular profiling to correlate profiles with and to predict dupilumab treatment response.

Eligibility criteria: Inclusion Criteria:

1. 18 years of age or older
2. atopic dermatitis with a EASI (Eczema Area and Severity Index (EASI)) score of ≥7

Exclusion Criteria:

1. Known pregnancy
2. Known immunodeficiencies
3. Known parasitic infection -

Primary outcomes:
measure: Change in Eczema Area and Severity Index (EASI) score from baseline to 8-12 weeks
timeFrame: baseline and 8-12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Jeffrey Cheng, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Raymond Cho, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01932619: The Influence of Storage Container and Defrost Process on Components in Breast Milk
Official title: The Influence of Storage Container and Defrost Process on Components in Breast Milk
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Human Milk
Lead sponsor: Taichung Veterans General Hospital
Sponsor class: OTHER
First posted: 2013-08-30
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy mothers lactating breast milk during first year of their babies

Brief summary: Breast milk is best food for neonates and preterm infants. However many handling would be done if direct breastfeeding is not feasible, and it may result in nutrients change in human milk. We investigate the influence of storage in different containers and different thawing or heating methods on human milk nutrients.


Eligibility criteria: Inclusion Criteria:

* healthy mothers lactating during first year of their babies and have sufficient milk to donate

Exclusion Criteria:

* mothers who have insufficient milk for their babies
* mothers have major disease or on specific diet or drug which would affect breast milk composition

Primary outcomes:
measure: changes in nutrients of human milk after several processing
timeFrame: within first year of milk expression
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Division of Neonatology, Department of Pediatrics, Taichung Veterans General Hospital
Study officials:
References:
Clinical trial NCT00877019: Time Dependent Professional Toothbrushing Study
Official title: Time Dependent Professional Toothbrushing Study Comparing Sonicare With Manual Toothbrushes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Toothbrushing
Keywords: sonic brushes
time effectiveness
brush head design
ADA-toothbrush
professional brushing
time dependence
efficacy
toothbrush
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2009-04-07
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: Aim:

The study was designed to test the time dependent efficacy in plaque removal of four toothbrushes: one electric toothbrush, the Philips Sonicare Elite with long (A) and short (B) brushing head and two manual brushes, the Gaba Sensitve (C), and the ADA reference brush (D) and.

Materials and Methods:

The study was a single-blind, randomized clinical timer study consisting of four identical experiments testing each brush in one quadrant. The distribution of the quadrants and brushes was randomized so that always all brushes were used within one participant. The teeth were brushed by a dental hygienist for 10, 20, 30, 45, 60 und 90 seconds per quadrant. No toothpaste was used throughout this study. The plaque assessment (Tureskey modified QHI) was done after each time interval blinded on six sites per tooth by a separate investigator. Ninety subjects participated in the study and received a professional prophylaxis prior to the experiment. They were requested to refrain from brushing their teeth for 48 hours prior to the experiment.


Eligibility criteria: Inclusion Criteria:

* at least 24 evaluable teeth in the mouth

Exclusion Criteria:

* systemic disease
* regular drugs or actual antibiotics
* orthodontic banding or retention wires
* oral lesions or sites with a probing pocket depth X5 mm

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00223119: Comparison of Absorbable Sutures in Perineal Laceration Repair
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Perineal Laceration Repair
Keywords: perineal trauma
perineal laceration
persistent perineal pain
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2005-09-22
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the difference in pain scales between absorbable suture types for second-degree perineal laceration repair.


Eligibility criteria: Inclusion Criteria:

* At least 18 years of age
* Able to sign informed consent
* Vaginal laceration that requires sutures but does not involve the anal sphincter (third-degree tear) or rectal mucosa (fourth-degree tear)

Exclusion Criteria:

* Inability to speak and understand English or Spanish
* Previous diagnosis of vulvodynia, dyspareunia, or other chronic vulvar pain syndrome
* Extensive perineal warts or vulvar varicosities

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Norwalk
country: United States
facility: US Surgical
state: Connecticut
Study officials:
affiliation: Medtronic - MITG
name: Donna Doran
role: STUDY_DIRECTOR
References:
Clinical trial NCT01694719: Cognitive Control Training as an Adjunct to Behavioral Activation Therapy in the Treatment of Depression
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Keywords: Depression
Major Depressive Disorder
Behavioral Activation
Cognitive Training
Lead sponsor: Boston University
Sponsor class: OTHER
First posted: 2012-09-27
Enrollment: 26
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: The purpose of this study is to evaluate the potential effects of a cognitive training program when combined with a particular form of psychotherapy (behavioral activation therapy) for depression. Behavioral activation therapy targets changes in behavior as a method for improving a depressed individual's thoughts, feelings, and overall quality of life. This study is designed to test whether a computerized brain exercise called cognitive control training can enhance the effects of a 5-session behavioral activation therapy program. CCT has been shown to reduce depressive symptoms in two other studies, but it has not yet been combined with behavioral activation therapy. The investigators hypothesize that individuals assigned to the behavioral activation plus cognitive control training condition will demonstrate reduced depressive symptoms from pre to post treatment compared with those assigned to the behavioral activation plus computerized control condition. The investigators hypothesize that these gains will be maintained at one-month follow up.


Eligibility criteria: Inclusion Criteria:

1. Adults ages 18-65
2. Primary psychiatric diagnosis of major depressive disorder
3. Ability to read and speak English sufficiently to complete study procedures
4. If taking antidepressant or anxiolytic medication, participants must be taking a stabilized dose for a minimum period of at least 8 weeks prior to entry into the study
5. Willingness and ability to comply with the requirements of the study protocol

Exclusion Criteria:

1. Lifetime history of bipolar disorder or psychotic disorder
2. Neurological disorder such as Parkinson's disease or traumatic brain injury
3. Alcohol or substance dependence within the past 6 months
4. Substantial suicide risk
5. Concurrent psychotherapy initiated within 2 months of baseline, or ongoing psychotherapy of any duration directed specifically toward treatment of the depression other than general supportive therapy
6. Current use of antipsychotics, stimulants, or modafinil

Primary outcomes:
measure: Beck Depression Inventory
Secondary outcomes:
measure: Montgomery Asberg Depression Rating Scale
Other outcomes:
measure: Ruminative Response Scale
Locations:
city: Boston
country: United States
facility: Boston University - Translational Research Program
state: Massachusetts
Study officials:
References:
Clinical trial NCT04110119: Effectiveness of Chiropractic Application for Acute Low Back Pain
Official title: Effectiveness of Chiropractic Application in Patients With Acute Low Back Pain Presenting to the Emergency Department and Receiving Drug Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Low Back Pain, Mechanical
Keywords: Mechanical Low Back Pain
Chiropractics
Analgesic-anti-inflammatory
myorelaxant
Thiocolchicoside
Lead sponsor: Medipol University
Sponsor class: OTHER
First posted: 2019-10-01
Enrollment: 98
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this project is to investigate the effectiveness of chiropractic application on patients who have undergone routine medication as a standard hospital treatment for mechanical low-back pain as described in the Clinical Practice Guidelines


Eligibility criteria: Inclusion Criteria:

* Aged between 19 and 65.
* Acute lower-back pain, persisting less than 6 weeks, meeting the diagnostic classification of 1 or 2 according to the Quebec Task Force on Spinal Disorders

Exclusion Criteria:

* Previous spine surgery
* Spinal nerve root irritation or deficits,
* Pregnant women,
* Lower-back pain due to occupational accidents
* Obesity status (body mass index\> 30).
* Chronic lower-back pain longer than 6 weeks.

Primary outcomes:
measure: Change in pain level
timeFrame: Up to 5 minutes
measure: Change in pain level
timeFrame: Up to 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Beykoz
country: Turkey
facility: Medipol University
state: Istanbul
Study officials:
References:
Clinical trial NCT00532519: Effectiveness of the Selective Serotonin Reuptake Inhibitor,Citalopram (Cipralex), in Prurigo Nodularis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prurigo Nodularis
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2007-09-20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Prurigo nodularis (PN) is a common dermatological disorder, manifested as scaly nodules which appear mainly on the extensor surfaces of the limbs. PN may appear secondarily to skin scratching in chronic hepatitis, liver cirrhosis, uremia, hypothyroidism etc. Nevertheless, in many cases no underlying physical disease is present. According to the literature, in fifty percent of the patients there is co-morbidity with depression, anxiety or somatoform disorders.

We hypothesize that a group of these patients may benefit from antidepressant therapy.


Eligibility criteria: Inclusion Criteria:

* prurigo nodularis
* age: 18-70 years
* agreed to participate

Exclusion Criteria:

* younger than 18 or older than 70
* pregnant or lactating women
* chronic diseases: cancer, neurological disorders, diseases that are known to be associated with pruritus such as liver cirrhosis, uremia, etc.
* sensitivity to cipralotam
* psychosis, bi-polar disorder, substance addiction, use of antidepressant in the previous year
* use of systemic therapies to prurigo nodularis such as thalidomide, cyclosporine

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: : Hadassah Medical Organization,
Study officials:
affiliation: Hadassah Medical Organization
name: liran horev, md
role: PRINCIPAL_INVESTIGATOR
affiliation: Hadassah Medical Organization
name: rena cooper-kazaz, md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01789619: Extended Release Tacrolimus (Advagraf®) in Severe Adult Atopic Dermatitis Patients
Official title: Extended Release Tacrolimus (Advagraf®) in Severe Adult Atopic Dermatitis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atopic Dermatitis
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
First posted: 2013-02-12
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with severe atopic dermatitis, who can not be treated adequately with Cycloporin A because of side effects and/or non-responsiveness.

Brief summary: To evaluate the clinical efficacy of the extended release formulation of tacrolimus (Advagraf®) in patients with severe atopic dermatitis, who can not be treated adequately with cyclosporine A because of side effects and/or non-responsiveness.


Eligibility criteria: Inclusion Criteria:

* Adult patients with severe atopic dermatitis, uncontrolled by topical treatment (indication for oral immunosuppressive drugs), who are unresponsive to Cyclosporin A, or in which treatment was discontinued because of side effects.

Exclusion Criteria:

* Concomitant use of other oral immunosuppressive drugs and/or UV light therapy
* Preexisting abnormalities in liver function, kidney function or haematological abnormalities
* History of malignancy within the last 5 years
* Uncontrolled hypertension
* Pregnancy or lactation; wish for pregnancy during the treatment period
* Infections requiring continued therapy
* Known positivity for HIV
* Evidence of drug and/or alcohol abuse

Primary outcomes:
measure: Change in Scoring Atopic Dermatitis (SCORAD)
timeFrame: Every 4 weeks up to one year
Secondary outcomes:
measure: Change in Patient-Oriented Eczema Measure (POEM)
timeFrame: Every 4 weeks up to one year
measure: Change in Thymus and Activation-Regulated Chemokine in serum (TARC)
timeFrame: Every 4 weeks up to one year
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
Study officials:
affiliation: UMC Utrecht
name: C AFM Bruijnzeel-Koomen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03474419: Evaluation of the Satisfaction of the Patients Operated for a Mild Hyperplasie of the Prostate by Laser in Ambulatory Surgery
Official title: Evaluation of the Satisfaction of the Patients Operated for a Mild Hyperplasie of the Prostate by Laser in Ambulatory Surgery
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Prostatic Hyperplasia
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2018-03-22
Enrollment: 0
Sex: MALE
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: 33 patients selected in the 6 center

Brief summary: Every year more than 70 000 interventions for prostatic adenoma are realized. Several type of surgery are realized going of the ambulatory to longer hospital lengths of stay. There are also several techniques.However it appears that ambulatory surgery is less costly. The arguments of surgeons are patients reluctance or the difficulty to manage in case of complication.

The aim of the study is to show that there is a good acceptance from patient with a good level of satisfaction at day 30.


Eligibility criteria: Inclusion Criteria:

* Age\> 18
* patient with benign prostatic hyperplasia
* ambulatory eligibility

Exclusion Criteria:

* recused for ambulatory surgery
* Patients operated by surgeons not having ended their learning curve.

Primary outcomes:
measure: patient satisfaction
timeFrame: Day 30
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: