louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00739817: Screening for Primary Ciliary Dyskinesia Using Nasal Nitric Oxide
Official title: Screening for Primary Ciliary Dyskinesia Using Nasal Nitric Oxide
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Primary Ciliary Dyskinesia
Lead sponsor: Ziv Hospital
Sponsor class: OTHER_GOV
First posted: 2008-08-22
Enrollment: 6000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: community

Brief summary: Background: Primary ciliary dyskinesia (PCD) is a rare genetic disease characterised by recurrent respiratory infections and subfertility due to dysfunction of cilia (brushes) of the lining cells. Undiagnosed and untreated it can result in an irreversible crippling chronic lung disease. The diagnosis of PCD is a difficult one and involves the complex assessment of ciliary structure and function. Thus, PCD is under diagnosed and appropriate preventative and symptomatic treatment may be denied in many patients. In addition, the gene responsible for PCD is at present unknown, thus preventing pre-natal diagnosis and genetic counseling.

Working hypothesis and aims: Recently, it has become apparent that the evaluation of nasally expired nitric oxide (NO) constitutes a simple and non-invasive diagnostic method, which discriminates between PCD patients, PCD carriers and healthy controls at high rate of specificity and sensitivity. Testing is simple and last approximately one minute. We have recently identified a unique isolated Druze population with high prevalence of PCD. The high frequency of disease places this closed community at a high risk of undiagnosed PCD.

The aim of this project is to use nasal NO measurement as a screening tool to identify possible undiagnosed cases of PCD and PCD carriers in this high risk Druze population.


Eligibility criteria: Inclusion Criteria:

* Voluntary willing to participate

Exclusion Criteria:

* Recent URTI
* Steroids use 2 weeks prior to testing

Primary outcomes:
measure: Nasal NO < 105 ppb
timeFrame: at enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Safed
country: Israel
facility: Pediatric Department, Ziv Medical Center
Study officials:
References:
Clinical trial NCT00199017: German Multicenter Trial for the Treatment of Newly Diagnosed T-lymphoblastic Lymphoma in Adults
Official title: Multicenter Trial for Treatment Optimization in T-lymphoblastic Lymphoma in Adults and Adolescents Older Than 15 Years (GMALL T-LBL 1/2004) (Amend 1)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Lymphoma, Lymphoblastic
Keywords: T-LBL
Treatment
De novo
Chemotherapy
Adult
Lymphoma, lymphoblastic, T-cell
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 75
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study evaluates the efficacy and tolerability of treatment for T-lymphoblastic lymphoma (T-LBL) according to a protocol for acute lymphoblastic leukemia. Patients receive one year of intensive cyclical chemotherapy with additional prophylaxis for central nervous system (CNS) relapse by intrathecal therapy and cranial irradiation and mediastinal irradiation after induction chemotherapy.


Eligibility criteria: Inclusion Criteria:

* T-lymphoblastic lymphoma (bone marrow \[BM\] involvement \< 25%)
* Aged 15-65 years (55-65 years if biologically younger)
* Written informed consent

Exclusion Criteria:

* Severe complications due to lymphoma or secondary disease
* T-LBL as second malignancy or other active second malignancy
* Cytostatic pretreatment of LBL (exception of emergency treatments)
* Pregnancy
* Severe psychiatric illness or other circumstances which may compromise cooperation of the patient or informed consent
* Participation in other study interfering with study treatment

Primary outcomes:
measure: remission rate, remission duration, disease free survival, overall survival
Secondary outcomes:
measure: time and dose compliance, toxicity according to World Health Organization (WHO)
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: University Hospital, Medical Dept. II
Study officials:
affiliation: University Hospital Frankfurt, Medical Dept. II
name: Dieter Hoelzer, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00638417: Treatment and Rehabilitation of Patients With Hip Arthroplasty to Regain Walk and Work Efficiency and Quality of Life
Official title: Treatment and Rehabilitation of Patients With Hip Arthroplasty to Regain Walk and Work Efficiency and Quality of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Hip
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: OrtoMedic A/S, Oslo
name: Scandinavian Customized Prosthesis (SCP)
First posted: 2008-03-19
Enrollment: 24
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 aim of the study is to improve hospital treatment and rehabilitation of patients with hip arthroplasty to help the patients to regain functional ability in the shortest possible time, and reduce hospital and rehabilitation time to save costs for the patient and society.

Optimal reconstruction of the hip joint and the effect of an intensive physical training programme are compared to conventional rehabilitation programmes.


Eligibility criteria: Inclusion Criteria:

* Primary osteoarthritis
* Unilateral osteoarthritis
* Age below 65 yrs
* ASA group 1-2

Exclusion Criteria:

* Pregnancy
* Age below 18 yrs
* Cardiovascular disease
* Diseases in the musculoskeletal system that could influence on training

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Faculty of Medicine, NTNU
Study officials:
affiliation: Norwegian University of Science and Technology
name: Jan Hoff, prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Husby VS, Helgerud J, Bjorgen S, Husby OS, Benum P, Hoff J. Early maximal strength training is an efficient treatment for patients operated with total hip arthroplasty. Arch Phys Med Rehabil. 2009 Oct;90(10):1658-67. doi: 10.1016/j.apmr.2009.04.018.
Clinical trial NCT00758017: Efficacy of Different Acupuncture Methods for Chronic Low Back Pain
Official title: Efficacy of Different Acupuncture Methods for Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Keywords: low back pain
acupuncture
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2008-09-23
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate pain intensity over 8 weeks in acupuncture patients with chronic low back pain and to compare 2 different groups of patients which differ in the acupuncture method used to treat the pain.


Eligibility criteria: Inclusion Criteria:

* diagnosis of chronic low back pain (for at least 3 months) confirmed by a consultant
* indication for treatment of low back pain with acupuncture confirmed by a consultant
* at least 40 mm on a VAS pain scale

Exclusion Criteria:

* acupuncture during the last 6 months
* start of a new therapy for low back pain within the last 4 weeks
* pregnancy
* substance or drug abuse

Primary outcomes:
measure: Pain intensity over 8 weeks (area under the curve)
timeFrame: 8 weeks
Secondary outcomes:
measure: Intensity of back pain at week 8 and week 26
timeFrame: baseline, week 8, week 26
measure: Back function (FFbH-R)
timeFrame: baseline, week 8, week 26
measure: QoL
timeFrame: baseline, week 8, week 26
measure: Days with medication intake
timeFrame: baseline to end of week 8
measure: Days with physical therapy because of back pain
timeFrame: baseline to end of week 8
measure: Sick leave days
timeFrame: baseline, at week 8, at week 26
measure: Number of therapy sessions
timeFrame: baseline to expected time frame 3 months
measure: Duration of therapy
timeFrame: baseline to expected time frame 3 months
measure: Adverse effects and severe adverse effects
timeFrame: baseline to expected time frame 3 months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: ambulatory practice Yang-Strobel
Study officials:
affiliation: Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center, Berlin, Germany
name: Claudia M. Witt, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pach D, Yang-Strobel X, Ludtke R, Roll S, Icke K, Brinkhaus B, Witt CM. Standardized versus Individualized Acupuncture for Chronic Low Back Pain: A Randomized Controlled Trial. Evid Based Complement Alternat Med. 2013;2013:125937. doi: 10.1155/2013/125937. Epub 2013 Oct 28.
Clinical trial NCT01379417: Probiotics Supplementation in Premature Infants
Official title: Probiotics Supplementation and Nutritional Benefit in Premature Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prematurity
Keywords: Prematurity
Nutrition
Growth
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2011-06-23
Enrollment: 199
Sex: ALL
Minimum age (years): 1
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The main objective is to assess the nutritional benefit of probiotics supplementation on premature infants growth. As secondary objectives, different parameters related to probiotics tolerance will be measured.


Eligibility criteria: Inclusion criteria

* Gestational age between 26 weeks and 31 weeks
* Birth weight between 700 to 1600 g
* Eutrophic infants (weight between -2 to 2 DS, Usher curves)
* Admitted to one of the participating hospital unit within the 8 days following the birth, the birth date equals the 1st day of life.
* Still on parenteral feeding or infusion on the 5th day of birth

Non inclusion criteria

* Digestive disorders \> or equal to 1b on Bell stage
* Severe intra-ventricular haemorrhage (stage 3-4) before 5th day of life.
* Severe malformations or digestive malformations
* No antenatal corticosteroid therapy
* Severe medical or surgical disorder affecting the absorption, digesting and as a result the growth (Hirschsprung disease, lactose intolerance, cow milk protein allergy, mucoviscidosis).
* Parents geographical distance preventing the hospitalization follow-up in the hospital participating unit (geographical distance planned before the infant reaches 1500 g or 32 weeks of gestational age)

Exclusion criteria

* Enteral/Oral feeding termination during more than 72 hours due to severe digestive disorders (\> or equal to 2a on Bell stage )
* Serious digestive surgery

Primary outcomes:
measure: Weight (g)
timeFrame: From 4 to 6 weeks after inclusion
Secondary outcomes:
measure: Growth
timeFrame: between inclusion date and 4 to 6 weeks after inclusion (= end of supplementation period)
Other outcomes:
Locations:
city: Bron
country: France
facility: Service de Nénatologie, Hôpital Femme Mère Enfant
city: Lyon
country: France
facility: Service de Réanimation Néonatale et Néonatologie, Hôpital de la Croix Rousse
city: Montpellier
country: France
facility: Service de Réanimation Néonatale, Hôpital Arnaud de Villeneuve
Study officials:
affiliation: Hôpital de la Croix-Rousse
name: Jean-Charles Picaud, Pr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hays S, Jacquot A, Gauthier H, Kempf C, Beissel A, Pidoux O, Jumas-Bilak E, Decullier E, Lachambre E, Beck L, Cambonie G, Putet G, Claris O, Picaud JC. Probiotics and growth in preterm infants: A randomized controlled trial, PREMAPRO study. Clin Nutr. 2016 Aug;35(4):802-11. doi: 10.1016/j.clnu.2015.06.006. Epub 2015 Jul 16.
Clinical trial NCT00282217: Study Evaluating Sirolimus in the Treatment of Kidney Transplant
Official title: Sirolimus in the Treatment of Histological Defined Chronic Allograft Nephropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Kidney Failure
Kidney Diseases
Keywords: Kidney Failure
Kidney Transplant
Graft Rejection
Kidney Transplantation
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2006-01-25
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to test whether withdrawal of calcineurin inhibitors, followed by treatment with sirolimus, may improve renal function in renal transplant recipients with chronic allograft nephropathy.


Eligibility criteria: Inclusion Criteria:

* Renal transplantation
* Biopsy-confirmed chronic rejection
* Treatment with mofetil mycophenolate among cyclosporine or tacrolimus

Exclusion Criteria:

* Transplant of any organ other than the kidney
* Current important infection
* Acute rejection within 12 weeks prior to inclusion

Primary outcomes:
measure: Renal function at 12 months; Comparison between slopes of glomerular filtration rate (GFR) of one year before versus one year after start on sirolimus
Secondary outcomes:
measure: Histological parameters at 12 months
measure: Cumulative incidence of biopsy-confirmed acute rejection at 12 months
measure: Effect at 12 months on proteinuria, blood pressure, hyperlipidemia, and proteinuria
Other outcomes:
Locations:
city: Albacete
country: Spain
city: Barcelona
country: Spain
city: Cadiz
country: Spain
city: Granada
country: Spain
city: L'Hospitalet de Llobregat
country: Spain
city: La Coruna
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Malaga
country: Spain
city: Oviedo
country: Spain
city: Sevilla
country: Spain
city: Zaragoza
country: Spain
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
affiliation: For Spain, infomed@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01213017: The Effect of Certolizumab Pegol on MRI Synovitis and Bone Edema in Rheumatoid Arthritis Patients
Official title: The Effect of Certolizumab Pegol in Combination With Methotrexate on MRI Synovitis and Bone Edema and Patient Reported Outcomes as Measured Using an Automated Visit Manager System in Moderate to Severe Rheumatoid Arthritis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Keywords: Certolizumab pegol
Magnetic Resonance Imaging
Rheumatoid Arthritis
RAPID 3
Lead sponsor: Oklahoma Medical Research Foundation
Sponsor class: OTHER
Collaborators: name: UCB Pharma
First posted: 2010-10-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether Certolizumab pegol can rapidly reduce the inflammatory changes and inhibit erosions on hand and wrist MRI in patients with active moderate to severe rheumatoid arthritis.

Detailed description: The primary objective of this study is to evaluate the efficacy of CSP used in combination with MTX in patients with active moderate to severe RA by evaluating change from baseline in synovitis and bone edema MRI scores at week 6.

Eligibility criteria: Inclusion Criteria:

* moderate to severe RA (DAS \> 4.4)
* at least two swollen and tender joints in one of the hand/ wrist
* patients must have failed at least one non-biologic or biologic DMARDs
* currently receiving MTX therapy

Exclusion Criteria:

* concomitant diseases or pathological conditions that could interfere and impact the assessment of the study treatment

Primary outcomes:
measure: the change from baseline in synovitis and bone edema RAMRIS score.
timeFrame: 6 weeks
Secondary outcomes:
measure: the change from baseline in RAMRIS erosion score
timeFrame: 16 and 52 weeks
Other outcomes:
Locations:
city: Aventura
country: United States
facility: Arthritis and Rheumatic Disease Specialties
state: Florida
city: Oklahoma City
country: United States
facility: Oklahoma Medical Research Foundation
state: Oklahoma
Study officials:
affiliation: Oklahoma Medical Research Foundation
name: Ewa Olech, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Arthritis and Rheumatic Disease Specialties
name: Norman B Gaylis, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00726141: Brief Interventions on Smoking for Hormonal Contraceptive Users
Official title: Brief Interventions on Smoking for Hormonal Contraceptive Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Keywords: Brief Intervention
Smoking Cessation
Motivational Interviewing
Expert System
Readiness to Change
Hormonal Contraceptive
Adolescents
Lead sponsor: University of Luebeck
Sponsor class: OTHER
First posted: 2008-07-31
Enrollment: 699
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Despite rising smoker rates, particularly in girls and young women, only few studies have focused on smoking cessation in young smokers. Gynaecologist practices may be an ideal setting to proactively intervene with young female smokers. Elevated health risks of smoking while using hormonal contraceptives could be a successful approach to gain young women's attention on smoking cessation. The purpose of this study is to evaluate the effectiveness of a smoking cessation intervention for girls and young women visiting gynaecologist practices and using hormonal contraceptives.

Detailed description: In the randomized controlled trial, female smokers aged 14-25 will be recruited in practices of gynaecologists. Intervention within the practice consists of a 30 minutes counseling session based on Motivational Interviewing, a standardised physician letter focusing on the elevated health risks of smoking while using hormonal contraceptives and a stage-matched self-help manual. After four weeks, an expert system feedback letter will be sent. In the intervention group, no smoking intervention will be given. Follow-up assessments will be conducted after 12 months, including saliva cotinine measures.

Eligibility criteria: Inclusion Criteria

* Age 14-25
* Having smoked at least 1 cigarette within last 4 weeks
* Use of hormonal contraceptives or intention for prescription within next 2 weeks

Exclusion Criteria:

* Pregnancy
* Emergency treatment

Primary outcomes:
measure: Smoking cessation
timeFrame: 12 months
Secondary outcomes:
measure: Reduction of smoking
timeFrame: 12 months
measure: Readiness to change variables
timeFrame: 12 months
measure: Level of nicotine dependence
timeFrame: 12 months
measure: Quit attempts
timeFrame: 12 months
Other outcomes:
Locations:
city: Lübeck
country: Germany
facility: University of Lübeck
Study officials:
affiliation: University of Luebeck
name: PD Dr. Hans-Jürgen Rumpf, Dipl.-Psych.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02110641: Lifestyle, Exercise and Nutrition Study 2 (LEAN 2)
Official title: Lifestyle, Exercise and Nutrition (LEAN) Study 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Weight Loss
Keywords: Breast Cancer
Survivorship
Weight Loss
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2014-04-10
Enrollment: 51
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The specific aims of this study are to determine the efficacy and cost-effectiveness of a weight loss program compared with usual care (control) treatment on 6-month changes in body weight, body fat, serum hormones, and breast tissue markers associated with prognosis in breast cancer survivors.

Detailed description: We will conduct a two-armed study comparing a combination of an in-person and telephone weight loss program compared to usual care/wait list in 100 breast cancer survivors. Women will be randomized into one of the study arms using a random permuted block design. Research staff collecting body composition data, as well as reviewing forms and entering data, will be blinded to the participant's study group.

Eligibility criteria: Inclusion Criteria:

* American Joint Committee on Cancer (AJCC) Stages 0-IIIC Breast Cancer
* BMI \>25 kg/m2
* Completed surgery, chemotherapy and radiation at least 2 months ago
* Physically able to exercise
* Agrees to be randomly assigned to either weight loss or control
* Gives informed consent to participate in all study activities
* Able to come for baseline and 6-month clinic visits
* Mentally competent

Exclusion Criteria:

* Patients with double mastectomy

Primary outcomes:
measure: Change in Body Mass Index (BMI)
timeFrame: 6 months
measure: Change in body weight in kilograms (kg)
timeFrame: 6 months
measure: Change in percent body fat
timeFrame: 6 months
measure: Change in breast tissue markers
timeFrame: 6 months
Secondary outcomes:
measure: Change in fasting insulin
timeFrame: 6 months
measure: Change in Leptin
timeFrame: 6 months
measure: Change in C-reactive protein
timeFrame: 6 months
measure: Skin Carotenoids Assessment
timeFrame: 6 months
measure: Maintenance of Weight Loss
timeFrame: 12 months
measure: Changes in salivary cortisol
timeFrame: 6 months
Other outcomes:
measure: Change in Physical Activity
timeFrame: 6 months
measure: Change in Dietary Intake
timeFrame: 6 months
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Yale University
name: Melinda L Irwin, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nguyen T, Irwin ML, Dewan AT, Cartmel B, Harrigan M, Ferrucci LM, Sanft T, Li F, Lu L, Salinas YD. Examining the effect of obesity-associated gene variants on breast cancer survivors in a randomized weight loss intervention. Breast Cancer Res Treat. 2021 Jun;187(2):487-497. doi: 10.1007/s10549-021-06151-5. Epub 2021 Mar 6.