louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00152243: A Randomized Controlled Study of Postoperative Adjuvant Chemotherapy of Uracil- Tegafur (UFT) Compared With Surgery Alone (NSAS-GC)
Official title: A Randomized Controlled Study of Postoperative Adjuvant Chemotherapy of UFT Compared With Surgery Alone for Serosa-negative Advanced Gastric Cancer (NSAS-GC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastric Cancer
Keywords: Stomach Cancer
Lead sponsor: Taiho Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2005-09-09
Enrollment: 500
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a controlled study designed to evaluate the efficacy of UFT on survival compared with surgery alone. Patients will be randomly assigned to receive either surgery alone or surgery followed by UFT within 6 weeks after curative resection. To assess treatment response, data on recurrence and survival will be collected for 5 years after enrollment of the last patient. To evaluate safety, data on adverse events will be collected for 16 months after the start of treatment.


Eligibility criteria: Inclusion Criteria:

* Age 20 to 75
* Performance status 0 , 1, or 2 (ECOG)
* Hematopoietic WBC ≥ 4,000/mm\^3 Platelet ≥ 100,000/mm\^3
* Hepatic AST and ALT ≤ 2 times upper limit of normal(ULN) Total bilirubin ≤ 1.5 times ULN
* Renal BUN ≤1.5 times ULN Creatinine ≤ 1.5 times ULN

Exclusion Criteria:

* Prior anticancer treatment

Primary outcomes:
measure: Overall survival and relapse-free survival
timeFrame: every course for first three courses, then every other course
Secondary outcomes:
measure: Adverse events
timeFrame: any time
Other outcomes:
Locations:
city: 3-10-6, Ariake, Koto-ku
country: Japan
facility: Cancer Institute Hospital, Japanese Foundation for Cancer Research
state: Tokyo
Study officials:
affiliation: Cancer Institute Hospital
name: Toshifusa Nakajima, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nakajima T, Kinoshita T, Nashimoto A, Sairenji M, Yamaguchi T, Sakamoto J, Fujiya T, Inada T, Sasako M, Ohashi Y; National Surgical Adjuvant Study of Gastric Cancer Group. Randomized controlled trial of adjuvant uracil-tegafur versus surgery alone for serosa-negative, locally advanced gastric cancer. Br J Surg. 2007 Dec;94(12):1468-76. doi: 10.1002/bjs.5996.
Clinical trial NCT03667443: Myo-inositol Plus Alpha-lactalbumin in PCOS Myo-inositol-resistant Patients
Official title: The Effects of Myo-inositol Plus Alpha-lactalbumin in Ovulation Induction of PCOS Myo-inositol-resistant Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: PCOS
Myo-inositol-resistance
Keywords: myo-inositol
alpha-lactalbumin
polycystic ovary syndrome
anovulation
infertility
Lead sponsor: Lo.Li.Pharma s.r.l
Sponsor class: INDUSTRY
First posted: 2018-09-12
Enrollment: 0
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The investigator's aim is to evaluate if the combination of myo-inositol and alpha-lactalbumin can overcome the resistance to myo-inositol in PCOS patients

Detailed description: In this study, the investigators expect about 30% of the PCOS patients enrolled to be resistant to Myo-inositol treatment for ovulation induction, probably due to the presence of malabsorption caused by gut dysbiosis. The most recent evidence proposes dysbiosis and related chronic low-grade inflammation as the new DOGMA behind PCOS pathogenesis. In this regard, the recent findings on alpha-lactalbumin reports its effect in improving the absorption of different nutrients including myo-inositol as well as a crucial factor for reducing inflammation. Furthermore, this whey protein is well known for its effect as trophic agent for gastrointestinal flora in infants. For all these reasons, the investigators expect that the treatment with Inofolic HP (Myo-inositol and alpha-lactalbumin) will get an efficacy 20-25% higher than the treatment with inofolic.

Eligibility criteria: Inclusion Criteria:

* POCS women diagnosed using the Rotterdam Criteria

Exclusion Criteria:

* Amenorrhea (3 months)
* Other conditions causing ovulatory disorders and/or androgens hyper production such as: hyperprolactinemia, hypothyroidism, adrenal hyperplasia and Cushing syndrome
* Hormonal and/or pharmacological treatments in the previous 3 months that could interfere with ovulation
* Drastic changes in diet
* Treatment with product containing Myo-inositol in the previous 3 months

Primary outcomes:
measure: ovulation induction
timeFrame: after three months of treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03703843: ARTUS MONO Artificial Urinary Sphincter
Official title: Feasibility of ARTUS MONO Artificial Urinary Sphincter Implant in Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence,Stress
Keywords: AUS
Artificial Urinary Sphincter
Lead sponsor: Myopowers Medical Technologies France SAS
Sponsor class: INDUSTRY
First posted: 2018-10-12
Enrollment: 3
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The ARTUS MONO implant is an active implantable medical device (AIMD) that assist the urethral sphincter function of female patients suffering from moderate to severe urinary incontinence, by remotely opening and closing a cuff placed around the bladder neck. The purpose of this clinical investigation is to evaluate the feasibility of implantation of the device, its safety and its efficacy, when temporarily implanted in female patients scheduled for anterior pelvic exenteration for bladder cancer.


Eligibility criteria: Inclusion Criteria:

1. Female patients aged ≥ 18 yo
2. BMI \> 18,5 and \< 35
3. Patient scheduled for an anterior pelvic exenteration with ileal conduit urinary diversion
4. Signed informed consent

Exclusion Criteria:

1. Advanced bladder cancer with bladder neck and/or urethral extension
2. Past pelvic radiation therapy
3. Patient previously treated with an artificial urinary sphincter or other urogenital implant
4. Positive urine culture during the past 2 weeks
5. Indwelling bladder catheter during the past 2 weeks
6. Documented history of sensitivity to silicone
7. History of connectivitis disease
8. Immunosuppressive therapy in the last 3 months
9. Vulnerable subjects
10. Participation in any other clinical investigation

Primary outcomes:
measure: Bladder catheterization in presence of ARTUS MONO cuff
timeFrame: Day 0
Secondary outcomes:
measure: ARTUS MONO cuff implant
timeFrame: Day 0
measure: ARTUS MONO cuff activation
timeFrame: Day 0
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Thomayer hospital
city: Paris
country: France
facility: Cochin Hospital
Study officials:
affiliation: Hôpital Cochin
name: Nicolas BARRY DELONGCHAMPS, PR
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05357443: SH Dr. Chen Gastric Bypass Study
Official title: Effect of Vagus Nerve Preservation During Gastric Bypass on Gastrin Level and Marginal Ulcer Formation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Gastric Bypass
Lead sponsor: Sanford Health
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2022-05-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluation of serum gastrin levels and their effect on marginal ulcer formation.

Detailed description: Prospective, randomized, interventional trial. Participants will be randomized to one of two surgical techniques, either with transection of the vagal nerves, or without. Outcomes including compare marginal ulcer rates will be compared using serum gastrin levels before and after surgery and gastric pH during surgery.

Eligibility criteria: Inclusion Criteria:

* Age 18 years and older
* Diagnosis of obesity or disorder of metabolism undergoing routine gastric bypass surgical intervention
* Capable of giving signed informed consent.

Exclusion Criteria:

* Under 18 years of age
* Ineligible for gastric bypass surgery
* Pregnant women or women actively seeking to become pregnant.

Primary outcomes:
measure: Incidence of Marginal Ulcer
timeFrame: From surgical intervention to five years after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Fargo
country: United States
facility: Sanford Health
state: North Dakota
Study officials:
affiliation: Sanford Health
name: Sugong Chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05045443: Safety and Efficacy of Curcumin in Children With Acute Lymphoblastic Leukemia
Official title: Safety and Efficacy of Curcumin in Children With Acute Lymphoblastic Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Lymphoblastic Leukemia, Pediatric
Keywords: Curcumin
Ain Shams University
Egypt
Acute Lymphoblastic Leukemia
Children
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-09-16
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Assessment of of the biological effects of curcumin on microbiota in children with acute lymphoblastic leukemia

Detailed description: Assessment of the safety of curcumin, which is the most active constituent of the ground rhizome of the Curcuma longa plant, in children with acute lymphoblastic leukemia patients (ALL) in maintenance phase of chemotherapy through the assessment of the any reported adverse event (AE). And assessment of the curcumin effect on health by eliminating intestinal microflora dysbiosis

Eligibility criteria: Inclusion Criteria:

Children aged from 1 year to 18 years Children with proven ALL diagnosed by bone marrow aspirate and immunephenotyping Patients in the maintenance phase week1

Exclusion Criteria:

Children with other maliganacies, Current use (past use of these medications is not an exclusion) of medications or over-the-counter treatments including to sulfasalazine, warfarin, clopidogrel, aspirin, antacids, botanical treatments (ginger, feverfew, yellow clover, Salix species, Populus species, Betula species, and Gaultheria species), essential fatty acids (flax oil and fish oil).

Primary outcomes:
measure: Determine the Safety of curcumin in pediatric patients with ALL.
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Pediatric Hematology Oncology and BMT Unit, Faculty of Medicine Ain Shams University
state: Non-US
Study officials:
affiliation: Faculty of Medicine Ain Shams University
name: Ihab Khairy, M.D
role: STUDY_CHAIR
References:
Clinical trial NCT04245943: Rehabilitation - Physical Activity and Coping
Official title: Rehabilitation - Physical Activity and Coping
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cancer Survivors
Keywords: Rehabilitation
Physical exercise
Return to work
Fatigue
Cancer survivors
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
First posted: 2020-01-29
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: OTHER

Brief summary: The project is a non-randomized intervention study with group-based physical exercise. Cancer survivors who have participated in the rehabilitation program at the Center for Education and Rehabilitation are included in the study.

The cancer and cancer treatment have led to patients struggling with physical, mental and social late effects which prevent them from functioning in everyday life and return to work. The purpose of the project is to investigate whether one municipal group training measure can help to lower the threshold for the user to maintain good exercise habits and return to work / everyday life, as well as the effect on the user's physical form and quality of life and the transition between health level and the body itself measure.


Eligibility criteria: Inclusion Criteria:

* 18 years
* Women and men
* Regardless of cancer diagnosis
* Resident in Bergen municipality
* Finishes their rehabilitation at The Cancer Center for Education and Rehabilitation spring/summer 2019.

Exclusion Criteria:

* Patients who do not speak or understand Norwegian
* Unable to express themselves in writing
* Unable to perform basic daily tasks
* Display cognitive disorder or severe emotional instability
* Suffer from other debilitating illnesses / conditions that may inhibit physical exercise (heart failure, chronic obstructive pulmonary disease, orthopedic conditions, neurological disorders or the like) will be excluded from the study. -

Primary outcomes:
measure: Objectively recorded physical activity level
timeFrame: 18 weeks
Secondary outcomes:
measure: Change in maximal oxygen uptake measured by VO2max
timeFrame: 18 weeks
measure: Change in maximal strength
timeFrame: 18 weeks
measure: Change in quality of life measured by Short Form Health Survey (SF-36)
timeFrame: 18 weeks
measure: Change in fatigue scores using the Chalder Fatigue Questionaire (FQ)
timeFrame: 18 weeks
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Helse Bergen,
Study officials:
affiliation: Helse Bergen, Cancer Center for Education and Rehabilitation
name: Cecilia Arving, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04153643: Meniscus Surgery Registry
Official title: Arthroscopic Partial Meniscectomy Registry
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Meniscus Lesion
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
First posted: 2019-11-06
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults undergoing arthroscopic partial meniscectomy

Brief summary: The purpose of this study is to create a data registry of arthroscopic partial meniscectomies performed at our institution. This information will then be used to examine trends over time, predictive factors, and outcomes of arthroscopic partial meniscectomy.


Eligibility criteria: Inclusion Criteria:

* Scheduled to undergo arthroscopic partial meniscectomy with one of the study investigators at University at Buffalo Medical Doctors Orthopaedics and Sports Medicine

Exclusion Criteria:

* Non-english speaking

Primary outcomes:
measure: Knee Pain Score
timeFrame: 20 years
Secondary outcomes:
Other outcomes:
Locations:
city: Amherst
country: United States
facility: UBMD Orthopaedics & Sports Medicine
state: New York
Study officials:
References:
Clinical trial NCT02650843: Non-motor Symptoms and Brain Dopamine Transporter Binding
Official title: Non-motor Symptoms and Brain Dopamine Transporter Binding: An Observational Study in Parkinsonism
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Parkinson Disease
Parkinsonism
Keywords: Parkinsonism
DAT Dopamine transporter
SPECT
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Helsinki University Central Hospital
First posted: 2016-01-08
Enrollment: 455
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with parkinsonism

Brief summary: This project aims to clarify the role non-motor symptoms in the development of Parkinson's disease (PD) and to improve diagnostics at very early stages of PD. The project involves multidimensional measures of disease biomarkers together with brain dopamine transporter (DAT) imaging with \[123I\]FP-CIT single photon emission computed tomography (SPECT).


Eligibility criteria: Inclusion Criteria:

* Male or Female
* Age 18-100 years
* Referred for clinical DAT SPECT in Turku or Helsinki

Primary outcomes:
measure: DAT SPECT striatal specific binding ratio
timeFrame: Up to 10 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Eklund M, Nuuttila S, Joutsa J, Jaakkola E, Makinen E, Honkanen EA, Lindholm K, Vahlberg T, Noponen T, Ihalainen T, Murtomaki K, Nojonen T, Levo R, Mertsalmi T, Scheperjans F, Kaasinen V. Diagnostic value of micrographia in Parkinson's disease: a study with [123I]FP-CIT SPECT. J Neural Transm (Vienna). 2022 Jul;129(7):895-904. doi: 10.1007/s00702-022-02517-1. Epub 2022 May 27.
citation: Nuuttila S, Eklund M, Joutsa J, Jaakkola E, Makinen E, Honkanen EA, Lindholm K, Noponen T, Ihalainen T, Murtomaki K, Nojonen T, Levo R, Mertsalmi T, Scheperjans F, Kaasinen V. Diagnostic accuracy of glabellar tap sign for Parkinson's disease. J Neural Transm (Vienna). 2021 Nov;128(11):1655-1661. doi: 10.1007/s00702-021-02391-3. Epub 2021 Jul 30.
Clinical trial NCT01424943: Family Networks Project Study One: An Efficacy Study of Stepping Stones Triple P for Children Under Age Two
Official title: The Family Networks Project Study One: Supporting Family Confidence, Competence, and Community Connections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prevent Child Maltreatment
Keywords: prevention
evidence-based parenting intervention
children
disabilities
IDEA Part C
Stepping Stones Triple P
Lead sponsor: University of South Carolina
Sponsor class: OTHER
Collaborators: name: Quality Improvement Center for Early Childhood
First posted: 2011-08-29
Enrollment: 49
Sex: ALL
Minimum age (years): 11
Maximum age (years): 23
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the project is to assess the initial efficacy of Stepping Stones Triple P-Positive Parenting Program (SSTP) with parents of children below age two with developmental disabilities to strengthen families and prevent child maltreatment.

Detailed description: This study is an initial efficacy trial of SSTP for parents of children below age 2. The target population consists of 50 families of young children ages 11-23 months with developmental disabilities who are eligible to receive IDEA Part C (Individuals with Disabilities Education Act Part C) services in one region of South Carolina. Families will be randomly assigned to one of two conditions (1) IDEA Part C services as usual or (2) IDEA Part C services plus SSTP. Project goals are to strengthen parent competence, enhance parent confidence, and strengthen child social, emotional and behavioral functioning. Ultimately, this should result in a reduced likelihood of child maltreatment

Eligibility criteria: Inclusion Criteria:

* child age between 11 and 23 months of age
* child eligible for IDEA Part C Services
* parent english speaking
* parent willing to allow in-home services

Exclusion Criteria:

* disability requiring extensive out of home treatment

Primary outcomes:
measure: Parenting Style
timeFrame: Baseline, 5 months
measure: Child Behavior
timeFrame: Baseline, 5 months
measure: Parenting Self-confidence
timeFrame: Baseline, 5 months
measure: KIPS
timeFrame: Baseline, 5 months
Secondary outcomes:
measure: Parent Symptoms of Depression, Anxiety and Stress
timeFrame: baseline, 5 months
Other outcomes:
Locations:
city: Columbia
country: United States
facility: Parenting and Family Research Center
state: South Carolina
Study officials:
affiliation: Research Associate Professor, Parenting and Family Research Center, University of South Carolina
name: Cheri Shapiro, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02280343: Oscillation Mechanics of the Respiratory System Asbestos Exposed: Early Diagnosis
Official title: OSCILLATION MECHANICS OF THE RESPIRATORY SYSTEM ASBESTOS EXPOSED : Early Diagnosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Asbestosis
Keywords: forced oscillation tecnique
lung function
asbestosis
Lead sponsor: Rio de Janeiro State University
Sponsor class: OTHER
First posted: 2014-10-31
Enrollment: 2
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: exposed to asbesto

Brief summary: Inhalation of dust containing asbestos results in a process of interstitial pulmonary fibrosis called asbestosis. The Forced Oscillation Technique (FOT) evaluates the respiratory mechanics describing resistive, elastic and inertial properties. We believe that this technique may contribute to the early diagnosis of asbestosis.

Detailed description: The aims of this study were (1) to use the FOT to analyze how respiratory mechanics is affected in patients with asbestos exposed, (2) to identify the best FOT parameters for the diagnosis of respiratory changes in these patients (3) Assess whether the presence of obstructive changes is associated with the smoking habit.The control group (CG) included 24 subjects with normal spirometric data and without a history of smoking or pulmonary disease formed by workers and students UERJ and FioCruz. Volunteers with asbestos exposure were from the Department of CESTEH/ FioCruz, totaling 24 exposed and 7 with diagnoses of asbestosis.

The diagnosis of asbestosis was established based on a history of substantial exposure to asbestos dusts and compatible radiological features, together with exclusion of other competing diagnoses.

The tests included a standardized questionnaire on respiratory symptoms, clinical evaluation; Plain radiography of the chest; FOT, plethysmography and spirometry, in that order.

Eligibility criteria: Inclusion Criteria:

* diagnosis of asbestosis

Exclusion Criteria:

* other diseases

Primary outcomes:
measure: changes in pulmonary mechanicals
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Paula Morisco de Sá
Study officials:
affiliation: Universidade do Estado do Rio de Janeiro:Brazil
name: Paula Sá, research
role: PRINCIPAL_INVESTIGATOR
References: