louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01291615: Phase I Study of Gemcitabine or S-1 Adjuvant Therapy After Hemihepatectomy for Biliary Tract Cancer
Official title: Phase I Study of Gemcitabine or S-1 Adjuvant Therapy After Hemihepatectomy for Biliary Tract Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Biliary Tract Cancer
Lead sponsor: Kansai Hepatobiliary Oncology Group
Sponsor class: NETWORK
First posted: 2011-02-08
Enrollment: 6
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To decide maximum tolerated dose and/or recommended dose of Gemcitabine or S-1 adjuvant therapy after hemihepatectomy

Detailed description: There is no standard adjuvant therapy after liver hemi-hepatectomy due to bile duct cancer, because of high surgical morbidity ratio and high adverse event ratio of adjuvant therapy. For example, our preliminary results showed that regular gemcitabine administration (1000mg/m2, day1, 8, 15 every 4 weeks) after hemihepatectomy was too toxic and induced severe leukocytopenia and/or thrombocytopenia. Herein, we planned this study to decide more safety adjuvant protocol(recommend dose) for gemcitabine and S-1 after hemihepatectomy using continual reassessment method analysis. In this study, we decided that tolerable ratio of dose-limiting toxicity would be less than 10%.

Eligibility criteria: Inclusion Criteria:

1. Biliary tract cancer (\>= UICC Stage IB)
2. R0 or R1 resection due to biliary tract cancer (BTC)
3. ECOG performance status must be 0 or 1
4. The patient underwent no other treatment than surgery for BTC
5. Neutrophil must be over 1500/μl, platelet must be over 100,000/μl, AST and ALT must be less than five times the normal limit, total bilirubin must be less than three times the normal limit, and creatinin must be less than 1.2 mg/dl.
6. The patient can intake drugs per os.
7. From 4 to 12 weeks after the surgery
8. Written informed consent

Exclusion Criteria:

1. Existence of active double cancer
2. The patient suffered from severe drug allergy
3. Sever complications (interstitial pneumonia, heart failure, renal failure, liver failure, ileus, incontrollable diabetes mellitus, and so on)
4. Any active infections exist.
5. Pregnancy
6. Severe mental disorder
7. Others

Primary outcomes:
measure: frequency in adverse events
timeFrame: up to 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Osaka
country: Japan
facility: Osaka University, Graduate School of Medicine
Study officials:
affiliation: Osaka University Graduate School of Medicine
name: Hiroaki Nagano, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Kobayashi S, Nagano H, Sakai D, Eguchi H, Hatano E, Kanai M, Seo S, Taura K, Fujiwara Y, Ajiki T, Takemura S, Kubo S, Yanagimoto H, Toyokawa H, Tsuji A, Terajima H, Morita S, Ioka T. Phase I study of adjuvant gemcitabine or S-1 in patients with biliary tract cancers undergoing major hepatectomy: KHBO1003 study. Cancer Chemother Pharmacol. 2014 Oct;74(4):699-709. doi: 10.1007/s00280-014-2543-4. Epub 2014 Jul 30.
Clinical trial NCT00367315: Efficacy and Safety of Lumiracoxib in Patients With Primary Knee Osteoarthritis (OA)
Official title: A 13-week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel Trial of 2 Different Dose Regimens of Lumiracoxib (100 mg od and 200 mg od Initial Dose for Two Weeks Followed by 100 mg od) in Patients With Primary Knee Osteoarthritis, Using Celecoxib (200 mg od) as a Comparator
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Knee Osteoarthritis
Keywords: Osteoarthritis, lumiracoxib, celecoxib, cyclooxygenase-2 inhibitors
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-08-22
Enrollment: 1684
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy and safety of using lumiracoxib in the treatment of patients with knee osteoarthritis (OA)


Eligibility criteria: Inclusion Criteria:

* Primary osteoarthritis of knee (confirmed by American College of Rheumatology \[ACR\] criteria).
* Requirement of regular non-steroidal anti-inflammatory drug (NSAID) therapy.

Exclusion Criteria:

* Evidence of active peptic ulceration within 12 months prior to the screening visit or history of active gastrointestinal bleeding within the previous 5 years.
* Known hypersensitivity to analgesics, antipyretics, or NSAIDS (including celecoxib).

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Overall OA pain intensity in the target knee on a 0-100 mm Visual Analog Scale (VAS) at 13 weeks.
measure: Patient's global assessment of disease activity on a 0-100 mm VAS at 13 weeks.
measure: Patient's functional status using Western Ontario and McMaster Universities Arthritis Index (WOMAC©) total score at 13 weeks.
Secondary outcomes:
measure: • Overall OA pain intensity in the target knee using 0-100 mm VAS, at weeks 2, 4, 8.
measure: Patient's global assessment of disease activity using 0-100 mm VAS, at weeks 2, 4, 8.
measure: Patient's functional status using WOMAC© Likert 3.1 sub-scale scores and total score, at weeks 2, 8, 13.
measure: Patient's health status using the Short Form-36 (SF-36), at week 13.
measure: Physician's global assessment of disease activity using 0-100 mm VAS, at weeks 2, 4, 8.
Other outcomes:
Locations:
city: Nuernberg
country: Germany
facility: Novartis
city: Basel
country: Switzerland
facility: Novartis
Study officials:
affiliation: Novartis
name: Novartis Pharmaceuticals
role: STUDY_CHAIR
References:
citation: Dougados M, Moore A, Yu S, Gitton X. Evaluation of the patient acceptable symptom state in a pooled analysis of two multicentre, randomised, double-blind, placebo-controlled studies evaluating lumiracoxib and celecoxib in patients with osteoarthritis. Arthritis Res Ther. 2007;9(1):R11. doi: 10.1186/ar2118.
Clinical trial NCT00819715: Electrogastrography in Small for Gestational Age Preterm Infants
Official title: Electrogastrography in Small for Gestational Age Preterm Infants Compared to Appropriate for Gestational Age Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Premature Birth
Keywords: Preterm infants
small for gestational age
electrogastrography
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2009-01-09
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Preterm infants \>31 weeks, - 37 weeks , healthy, on enteralfeeds

Brief summary: The purpose of this study is to determine whether small for gestational preterm infants, have delayed or decrease gastric motility compared to appropriate for gestational age preterm infants.


Eligibility criteria: Inclusion Criteria:

1. preterm infants 32-37 weeks' gestation
2. No sepsis or ventilation
3. Feeding orally or with NG tube.
4. Age \<48 h to be included

Exclusion Criteria:

1. GE reflux
2. Medication that affect gastric motility

Primary outcomes:
measure: EGG compatible with age
timeFrame: day 1 and day 7 after birth
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar-Saba
country: Israel
facility: Neonatal Department,Meir Medical Center
Study officials:
affiliation: Meir Medical Center
name: Shmuel Arnon, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Liang J, Co E, Zhang M, Pineda J, Chen JD. Development of gastric slow waves in preterm infants measured by electrogastrography. Am J Physiol. 1998 Mar;274(3):G503-8. doi: 10.1152/ajpgi.1998.274.3.G503.
Clinical trial NCT02925715: Comparative Evaluation of Ultrasound Guided Supraclavicular and Infraclavicular Subclavian Venous Catheterizations in Adult Patients Undergoing Major Surgeries
Official title: Comparative Evaluation of Ultrasound Guided Supraclavicular and Infraclavicular Subclavian Venous Catheterizations in Adult Patients Undergoing Major Surgeries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Compare Central Line Insertion of Subclavian Vein With Two Different Approaches Using Ultrasound
Lead sponsor: PGIMER
Sponsor class: UNKNOWN
First posted: 2016-10-06
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Comparison of two techniques of central venous cannulation of subclavian vein using ultrasound was performed. ultrasound guided central venous cannulation is the standard practice today but its use in subclavian vein is technically challenging and not much literature is available. In this study 96 Patients were randomized into one of the groups and compared for various outcomes. The primary outcome studied was the time taken for procedure. Secondary objectives included comparison of total access time using both the techniques,comparison of first attempt success rate, comparison of the quality of needle visualization and the comparison of immediate (mechanical) and delayed complication rates.


Eligibility criteria: Inclusion Criteria:

* Healthy adults requiring central venous cannulation.

Exclusion Criteria:

* History of prior catheterization.
* Limited sites for access attempts (other catheters, pacemaker, prior surgery).
* Previous difficulties during catheterization such as more than three punctures at one site, two sites attempted or failure to gain access.
* Previous mechanical complications during catheterization.
* Patients with infection at puncture site and contralateral pneumothorax.
* Patients with trauma to clavicle and upper ribs, distorted anatomy of neck or clavicles.
* Cervical spine injury.
* Known vascular abnormality.
* Untreated coagulopathy such as International Normalization Ratio(INR) ≥ 2, activated partial thromboplastin time \>1.5 of normal or platelets \<50,000/mm3
* After 3 attempts at needle puncture.

Primary outcomes:
measure: puncture time of subclavian vein using ultrasound-guided supraclavicular or infraclavicular approach infraclavicular approaches in adults
timeFrame: 1 year
Secondary outcomes:
measure: total time taken for cannulation of veins using both the techniques.
timeFrame: 1 year
measure: first attempt success rate
timeFrame: 1 year
measure: quality of needle visualisation
timeFrame: 1 year
measure: immediate and delayed complications with the two approaches
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05757115: Evaluation and Development of Playing Skills for Parents With Children With Special Needs
Official title: Evaluation and Development of Playing Skills for Parents With Children With Special Needs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Play and Playthings
Keywords: Neurodevelopmental Disorders, Autism Spectrum Disorders, Parents, Mentoring, Play and Playthings
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2023-03-07
Enrollment: 17
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Parents with children with special needs who want to participate in the study will be determined. The assessments will be applied to parents before and after play training. These trainings aim to develop the skills of playing games with their children.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Children with special needs; experiences physical, behavioral, social, cognitive and emotional limitations. These limitations affect the child's play skills. They need to be supported and encouraged by their parents to enable them to participate in the game. Parental playing skills creativity, self-efficacy and active participation are important factors in this regard.

In current studies, parents with special needs children; It is supported that there is a relationship between play, acting and parental self-efficacy. In this study, it was aimed to improve the skills of parents with special needs children to play games with their children multidimensionally and to develop these skills with individual-specific techniques.

Detailed assessments will be carried out in order to determine the functional, cognitive and psychosocial skills of the parents.

After the evaluation phase is completed, the scores of each parent will be analyzed and interpreted according to Occupational Therapy Models. Playing training will be given individually according to parameters such as strong and weak features, strong sensory system, personality traits, predisposition and defensive approaches.


Eligibility criteria: Inclusion Criteria:

* Being a mother of a special needs child
* The age of her child is 2-6 years
* Being able to speak Turkish
* Volunteer to participate in the study

Exclusion Criteria:

* Have training in play therapy
* Having a psychiatric or neurological disease that significantly affects cognitive status

Primary outcomes:
measure: Adult Playfulness Trait Scale
timeFrame: 2 mounths
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakıf University
state: İ̇stanbul
Study officials:
References:
Clinical trial NCT03618615: Anatomical Study of the Arteries of the Skin on Amputation Legs
Official title: Anatomical Study of the Arteries of the Skin on Amputation Legs
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Arteritic Leg Ulcer
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2018-08-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: arteritic patient coming to CHRUN as part of the care

Brief summary: PRIMARY OBJECTIVE Qualitatively describe the distribution of cutaneous arteries in patients with long-term occlusive arterial disease.

SECONDARY OBJECTIVE To compare the distribution of cutaneous arteries observed on the legs of arteritic patients with that observed on non-arteritic legs (from bodies given to science).

Detailed description: Arterial patient coming to CHRU Nancy, in the Vascular and Endoluminal Surgery Department, to undergo leg amputation.

Usually, after the amputation of the leg in the operating theatre, the surgical waste is destroyed.

Instead of being destroyed, the leg will be used for research.

Eligibility criteria: Inclusion Criteria:

* Major Patient
* Patient with late stage occlusive arteriopathy with lower limb amputation
* Patient who did not oppose the search
* Patient affiliated to a social security scheme

Exclusion Criteria:

* Patients with infectious diseases not accessible in the anatomy laboratory
* Woman of childbearing age without effective contraception
* Persons referred to in Articles L. 1121-5 to L. 1121-8 and L1122-2 of the Public Health Code :
* Pregnant woman, parturient or nursing mother
* Person deprived of liberty by a judicial or administrative decision,
* Person under psychiatric care pursuant to Articles L.3212-1 and L.3213-1 of the Public Health Code
* Person admitted to a health or social institution for purposes other than research
* Minor person (not emancipated)
* Adult subject to a legal protection measure (guardianship, trusteeship, protection of justice)
* Major person who is not in a position to express consent and who is not subject to a legal protection measure

Primary outcomes:
measure: Qualitative mapping of the skin's arteries.
timeFrame: 72 hours after the dissection of the leg.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04412915: Correlation Between Early Induction of Labor and Cesarean Delivery in Low-risk Nulliparous Women
Official title: Correlation Between Early Induction of Labor and Cesarean Delivery in Low-risk Nulliparous Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Risk Pregnancy
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2020-06-02
Enrollment: 2125
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Medical records of all consecutive primiparas with low-risk pregnancy from January 1, 2014 to August 31, 2019

Brief summary: To elucidate whether induction of labor in primiparas with low-risk pregnancies at 38 + 0 to 40 + 6 gestational weeks will increase the cesarean rate, compared with those receiving labor induction at more than 41+0 gestational weeks.

Detailed description: Medical records of all consecutive primiparas with low-risk pregnancy from January 1, 2014 to August 31, 2019 were reviewed to explore the correlation between early induction of labor and caesarean birth after 38 + 0 weeks. The hypothesis of the study is that induction of labor in primiparas with low-risk pregnancies at 38 + 0 to 40 + 6 gestational weeks will increase the cesarean rate, compared with those receiving labor induction at more than 41+0 gestational weeks.

Eligibility criteria: Inclusion Criteria:

* After 38 + 0 weeks of gestation
* low-risk pregnant primiparas
* singleton
* nulliparous
* \> 20 years old

Exclusion Criteria:

* Premature rupture of membranes

Primary outcomes:
measure: Cesarean rate rate
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Banqiao
country: Taiwan
facility: Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital
state: New Taipei
Study officials:
References:
Clinical trial NCT02778815: The Development and Initial Evaluation of a Web-based, Compassion-focussed Course for New Mothers
Official title: The Development and Initial Evaluation of a Web-based, Compassion-focussed Course for New Mothers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: New Mothers' Well-being
Lead sponsor: Canterbury Christ Church University
Sponsor class: OTHER
First posted: 2016-05-20
Enrollment: 272
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study examines the relationship between self-compassion and wellbeing in new mothers and whether an online self-help course for new mothers can help to improve their wellbeing and self-compassion.

Detailed description: This study is a randomised controlled trial (RCT) comparing an online self-help course ('Kindness for Mums') with a wait-list control. A battery of self-report measures will be administered online at baseline (week 0), post-intervention (week 6) and at follow-up (week 12). Baseline data will also be used to examine the relationship between self-compassion and wellbeing.

Eligibility criteria: Inclusion Criteria:

* New mothers (can be biological, adoptive or full-time foster mother)
* Able to complete baseline measures when infant aged 0-12 months
* Fluent in English
* Live in the United Kingdom
* Able to access the internet

Exclusion Criteria:

* Experiencing suicidal ideation at the time of enrolment

Primary outcomes:
measure: Change from baseline at 6-weeks on the Warwick-Edinburgh Mental Well-Being Scale
timeFrame: Post-intervention (i.e. 6-weeks after baseline)
Secondary outcomes:
measure: Change from baseline at 6-weeks on the Self-Compassion Scale
timeFrame: Post-intervention (i.e. 6 weeks post baseline)
measure: Change from baseline at 6-weeks on the Forms of Self-Criticising/Attacking and Self-Reassuring Scale
timeFrame: Post-intervention (i.e. 6 weeks post baseline)
measure: Change from baseline at 6-weeks on the Depression, Anxiety and Stress Scale 21-item version
timeFrame: Post-intervention (i.e. 6 weeks post baseline)
measure: Change from baseline at 12-weeks on the Warwick-Edinburgh Mental Well-Being Scale
timeFrame: 12-weeks after baseline
measure: Change from baseline at 12-weeks on the Self-Compassion Scale
timeFrame: 12-weeks after baseline
measure: Change from baseline at 12-weeks on the Forms of Self-Criticising/Attacking and Self-Reassuring Scale
timeFrame: 12-weeks after baseline
measure: Change from baseline at 12-weeks on the Depression, Anxiety and Stress Scale 21-item version
timeFrame: 12-weeks after baseline
Other outcomes:
Locations:
Study officials:
affiliation: Canterbury Christ Church University
name: Isobel Gammer, BA, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05485415: Intervention Study in Elderly With Sleep Problems
Official title: Personalised Circadian Intervention Study in Elderly With Sleep Problems
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Sleep Disturbance
Keywords: circadian
light
cognition
Zeitgeber
personalized
health
sleep
muliti-modal
Lead sponsor: University Psychiatric Clinics Basel
Sponsor class: NETWORK
Collaborators: name: University of California
First posted: 2022-08-03
Enrollment: 66
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Clinical Trial with a control group
Primary purpose: OTHER

Brief summary: The main objective of the study is to improve subjective sleep quality using a multimodal intervention with an intervention and a control group. The multimodal intervention aims to improve circadian Zeitgeber strength. This will be achieved by optimizing daily light exposure, sleep, physical activity, and mealtimes.

Detailed description: The study lasts for 14 months and contains 6 visits. After the screening visit at the Centre for Chronobiology, Basel, Switzerland, participants are assigned to either the intervention or the control group which is followed by a 7-day baseline week at home and a co-design meeting to provide instructions to the intervention and the control group. At the occasion of 2 visits (spread over 6 months) at the participants' homes, different measurements will be performed such as saliva collection, questionnaires, cognitive performance tests, light and rest-activity measures. After the last visit at home, participants come for the second blood sample at the study centre. A follow-up visit 6 months after completion of the last data collection will provide qualitative feedback by the participants.

Eligibility criteria: Inclusion Criteria:

at least 65 years old women and men

* Pittsburgh Sleep Quality Index (PSQI) \> 5 (indicative of sleep problems)
* Living at home (including self-serviced retirement apartment)

Exclusion Criteria:

* Total blindness or VA \< 0.5
* Progressive NCDs (e.g., cancer)
* Acute infections (e.g., Covid-19)
* Neurodegenerative disease
* Psychiatric disease
* Sleep disorder (sleep apnea, narcolepsy)
* Not German speaking

Primary outcomes:
measure: Subjective sleep quality
timeFrame: 6 months
Secondary outcomes:
measure: Sleep timing
timeFrame: 6 months
measure: Subjective wellbeing
timeFrame: 6 months
measure: Salivary melatonin concentration
timeFrame: 6 months
measure: Pupil size
timeFrame: 6 months
measure: Glucose metabolism
timeFrame: 6 months
measure: Telomere length
timeFrame: 6 months
measure: Neuropsychological Battery to assess working memory and attention (including n-back, Psychomotor Vigilance Test)
timeFrame: 6 months
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Centre for Chronobiology, Psychiatric Hopspital of the University of Basel
Study officials:
affiliation: Research Associate
name: Mirjam Münch, PhD
role: PRINCIPAL_INVESTIGATOR
References: