louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06522542: Gastric Cancer Complicated With Bleeding
Official title: Retrospective Study on Anti-cancer Therapy for Gastric Cancer Patients Complicated With Bleeding
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Gastric Cancer
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2024-07-26
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Advanced or metastatic gastric cancer at the Department of Medical Oncology and Radiation Sickness of Peking University Third Hospital.

Brief summary: To investigate the impact of bleeding on the survival and treatment-related adverse events (TRAEs) of gastric cancer patients.

Detailed description: We will retrospectively enroll patients diagnosed with advanced or metastatic gastric cancer at the Department of Medical Oncology and Radiation Sickness of Peking University Third Hospital. The retrospective study aims to investigate the impact of bleeding on treatment-related adverse events (TRAEs) for gastric cancer patients receiving systematic anticancer treatment, assess the influence of bleeding on the survival of patients.

Eligibility criteria: Inclusion Criteria:

1. Patients older than 18 years;
2. A histologically confirmed diagnosis of advanced or metastatic gastric cancer;
3. The initial anticancer treatment was systematic therapy, including chemotherapy, targeted therapy or immune checkpoint inhibitor (ICI);
4. No history of gastrectomy before systematic therapy.

Exclusion Criteria:

1. Incompletable clinical data;
2. Siewert I type esophagus cancer.

Primary outcomes:
measure: Overall survival (OS)
timeFrame: from date of the first cycle of systematic therapy to death from any cause，assessed up to 120 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of Medical Oncology and Radiation Sickness, Peking University Third Hospital
name: Yanhong Yao
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02999542: Effect of Music on Emergence Delirium
Official title: The Effect of Intraoperative Music on the Prevalence and Severity of Emergence Delirium in Paediatric Patients: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Emergence Delirium
Lead sponsor: University of Pretoria
Sponsor class: OTHER
First posted: 2016-12-21
Enrollment: 40
Sex: ALL
Minimum age (years): 2
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The researchers are conducting a research study to see whether listening to music during an operation will have a positive effect on the way that children wake up from surgery/anaesthetic. It is a common phenomenon where children wake up unhappy, irritated and screaming (known as emergence delirium). Research have shown that music decreases anxiety and pain. The researchers want to see whether music can also influence a child's behaviour after emerging from anaesthesia. In other words whether they will be more calm and cooperative after listening to music while they are asleep during surgery. Should music have a positive effect, anaesthesiologists may use it in future to improve care of patients coming for surgery.

Detailed description: Children coming for certain elective surgeries, where pain has been excluded as a confounding factor, will have headphones placed on their ears after induction of anaesthesia. They will be randomised to two groups, one will receive music and the other just silence. The headphones will be removed just before waking the patient up. In the recovery room the child's behaviour will be observed and will be scored according to a validated score. The two groups will then be compared to see whether music makes a difference to the behaviour after anaesthesia.

Eligibility criteria: Inclusion Criteria:

* Ages 2-7 years
* American society of anaesthesiologists class I and II patients
* Child has adequate hearing
* Surgery or procedure under general anaesthesia
* Receiving standardised anaesthetic
* Type of surgeries included: orthopaedic, urological, paediatric surgery and ophthalmology
* Minimum exposure to music must be 15minutes
* Child may not receive any premedication

Exclusion Criteria:

* American society of Anaesthesiologists class 3 and above
* Emergency cases
* Children with hearing problems
* Cognitive impairment

Primary outcomes:
measure: The effect of music on the prevalence of emergence delirium in paediatric patients
timeFrame: Up to 12 months
Secondary outcomes:
measure: The effect of music therapy on the severity of emergence delirium in paediatric patients.
timeFrame: Up to 12 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03663842: Effectiveness of a Novel Neural Tissue Management to Improve Short-term Pain and Disability in Patients With Sciatica
Official title: Effectiveness of a Novel Neural Tissue Management to Improve Short-term Pain and Disability in Patients With Sciatica
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sciatica Pain
Physical Therapy Modalities
Manual Therapies
Disability Evaluation
Keywords: Lumbosacral Plexus
Physical Therapy Modalities
Manual Therapies
Disability Evaluation.
Lead sponsor: Centro Universitário Augusto Motta
Sponsor class: OTHER
First posted: 2018-09-10
Enrollment: 44
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: Objectives: To analyse the effects of sciatic neural mobilisation, in combination to the treatment of the surrounding structures, on pain and disability. Secondly, to investigate baseline characteristics that may be associated with improvements in pain and lumbar disability. Methods: Twenty-eight patients with a clinical diagnosis of sciatica were treated with neural mobilization, joint mobilisation and soft tissue techniques. Pain intensity and lumbar disability were assessed at baseline and after treatment using a Numerical Rating Scale (0-10) and the Oswestry Disability Index (0-100), respectively. The pre- and post-intervention data were compared.


Eligibility criteria: Inclusion Criteria:

* Low back pain with radiating leg pain and/or paresthesia below the knee that follows the L5 and/or S1 dermatomal pattern.

Exclusion Criteria:

* History of lumbar and abdominal surgery
* Rheumatologic syndromes (e.g. Rheumatoid arthritis);
* Lumbar stenosis.

Primary outcomes:
measure: Pain intensity
timeFrame: From enrollment to end of treatment at 12 weeks
measure: Lumbar disability
timeFrame: From enrollment to end of treatment at 12 weeks.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Centro Universitário Augusto Motta
name: Renato Almeida, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03558542: Cardiopulmonary Rehabilitation in Chronic Stroke
Official title: Cardiopulmonary Rehabilitation in Chronic Stroke Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Hemiplegia
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2018-06-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is aimed to determine the effects of an accompanying structured cardiopulmonary rehabilitation program along with a neurorehabilitation program on the quality of life, care-giver burden and overall well-being of the patients.


Eligibility criteria: Inclusion Criteria:

* A history of ischemic stroke at least 6 months ago

Exclusion Criteria:

* any cardiac or pulmonary problem that renders the patient unavailable for the program
* mental impairment
* not being able to perform exercise testing
* not being able to walk independently

Primary outcomes:
measure: VO2max
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03860142: Evolution of Food Orality in Children Aged Between 24 and 36 Months: Comparison of the Severity and Specificities of Disorders Between Two Populations of Children, Born Very Prematurely and Born at Term
Official title: Evolution of Food Orality in Children Aged Between 24 and 36 Months: Comparison of the Severity and Specificities of Disorders Between Two Populations of Children, Born Very Prematurely and Born at Term
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infant, Premature, Diseases
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2019-03-01
Enrollment: 79
Sex: ALL
Minimum age (years): 24
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: term and prematurely born child

Brief summary: Oral disorders are currently widely described in the premature birth population, but few studies compare them to their prevalence in the full-term population.

In addition, new behaviours and eating habits are regularly emerging in our society.

The objective of this study is to compare the severity of signs of oral disorders between the group of preterm infants and the group of term infants born without organic pathologies that compromise oral development.


Eligibility criteria: Inclusion Criteria:

* Children whose age ≥ 24 months and ≤ 36 months
* Full-term or prematurely born (\<33 SA) at Nice University Hospital

Exclusion Criteria:

* Children with congenital pathologies (with malformations in the oro-facial sphere)
* Children with neurological and developmental pathologies unrelated to prematurity
* Children with ENT deformities
* Parental langage barrier

Primary outcomes:
measure: Archet scale score
timeFrame: 15 mn
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: Nice hospital
Study officials:
References:
Clinical trial NCT02591342: Comparison of a Cemented, Polished Tapered Stem and an Anatomic Stem for Femoral Neck Fracture
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hip Fracture
Femoral Neck Fracture
Periprosthetic Femoral Fracture
Keywords: femoral neck fracture
hip arthroplasty
complication
periprosthetic femoral fracture
Lead sponsor: Sundsvall Hospital
Sponsor class: OTHER
First posted: 2015-10-29
Enrollment: 1014
Sex: ALL
Minimum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We included all patients above the age of 80 years old, operated between September 2009 and April 2015 with a primary hip arthroplasty for an acute displaced femoral neck fractures. Patients were treated either with the cemented CPT or SP2 stems.

Brief summary: Postoperative periprosthetic femoral fracture after hip arthroplasty is associated with considerable morbidity and mortality. Recent cohort studies have demonstrated a high incidence of PPF in elderly patients treated with two commonly used polished, tapered, collarless stems in elderly patients. The aim of this study was to compare the rate and characteristics of PPF in a consecutive cohort of patients treated either the polished tapered CTP stem or the matte anatomic SP2 stem in an elderly population above 80 years of age with femoral neck fracture.


Eligibility criteria: Inclusion Criteria:

* Displaced femoral neck fracture
* Treated with a primary hip arthroplasty

Exclusion Criteria:

* Secondary arthroplasty due to sequel after femoral fracture

Primary outcomes:
measure: Incidence of periprosthetic femoral fracture
timeFrame: 2 years
Secondary outcomes:
measure: Type of periprosthetic femoral fracture
timeFrame: 2 years
measure: Type of complications after surgery for periprosthetic femoral fracture
timeFrame: 2 years
measure: Mortality
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Umeå University
name: Sebastian Mukka, M.D, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Broden C, Mukka S, Muren O, Eisler T, Boden H, Stark A, Skoldenberg O. High risk of early periprosthetic fractures after primary hip arthroplasty in elderly patients using a cemented, tapered, polished stem. Acta Orthop. 2015 Apr;86(2):169-74. doi: 10.3109/17453674.2014.971388. Epub 2014 Oct 3.
citation: Inngul C, Enocson A. Postoperative periprosthetic fractures in patients with an Exeter stem due to a femoral neck fracture: cumulative incidence and surgical outcome. Int Orthop. 2015 Sep;39(9):1683-8. doi: 10.1007/s00264-014-2570-0. Epub 2014 Oct 24.
citation: Thien TM, Chatziagorou G, Garellick G, Furnes O, Havelin LI, Makela K, Overgaard S, Pedersen A, Eskelinen A, Pulkkinen P, Karrholm J. Periprosthetic femoral fracture within two years after total hip replacement: analysis of 437,629 operations in the nordic arthroplasty register association database. J Bone Joint Surg Am. 2014 Oct 1;96(19):e167. doi: 10.2106/JBJS.M.00643.
Clinical trial NCT03061942: Arthroscopic Rotator Cuff Repair With Synovectomy
Official title: Arthroscopic Rotator Cuff Repair With Synovectomy; Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Tears
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 60
Sex: ALL
Minimum age (years): 19
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 assess the effect of synovectomy on clinical outcomes of arthroscopic rotator cuff repair.


Eligibility criteria: Inclusion Criteria:

- Patients with a full-thickness rotator cuff tear undergoing arthroscopic rotator cuff repair

Exclusion Criteria:

* History of shoulder surgery
* Acute trauma on affected shoulder
* Chronic dislocation
* Pyogenic infection
* Rotator cuff arthropathy with glenohumeral osteoarthritis and superior migration of the humeral head
* Isolated subscapularis tear
* Psychiatric problems that precluded informed consent
* An inability to read or write
* Other serious issues that precluded participation in the study
* Open surgery
* Rotator cuff tear with worker's compensation claim
* Refuse to participate in the study
* LOM that need brisement force
* Partial-thickness tear with focal full-thickness extension
* Irrepairable rotator cuff tear
* Subjects who, for any reason, are judged by the investigator to be inappropriate for this study, including a subject who had other severe medical condition or laboratory abnormality, or who is unable to communicate or to cooperate with the investigator

Primary outcomes:
measure: The worst pain VAS(visual analogue scale)
timeFrame: at 3 months after surgery
Secondary outcomes:
measure: Constant-Murley score
timeFrame: at 3 months after surgery
measure: The average pain VAS(visual analogue scale)
timeFrame: at 3 months after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine
Study officials:
References:
Clinical trial NCT06718842: Walking Program in Fatty Liver Children With Phenylketonuria
Official title: Walking Program in Fatty Liver Children With Phenylketonuria: Response of Liver Enzymes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Phenylketonurias
Non Alcoholic Fatty Liver
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-12-05
Enrollment: 40
Sex: ALL
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: phenylketonuria (commonly known as PKU) is an inherited disorder that increases the levels of a substance called phenylalanine in the blood. PKU is usually associated with many metabolic complication including non-alcoholic fatty liver

Detailed description: this study will include PKU children sufferers 9n=40) with non-alcoholic fatty liver to be randomly assigned to group I (n=20) that will perform walking program (online supervised free walking that will be applied daily for eight weeks) or group II (N=20) that will act as waitlisted children

Eligibility criteria: Inclusion Criteria:

* PKU children
* obese children
* fatty liver children (non-alcoholic fatty liver)

Exclusion Criteria:

* cardiac children
* diabetic children
* neurogenic disorders
* respiratory and renal problems

Primary outcomes:
measure: alanine transamianse
timeFrame: it will be assessed after eight weeks
Secondary outcomes:
measure: aspartate tranaminase
timeFrame: it will be assessed after eight weeks
measure: Gamma-glutamyl Transferase
timeFrame: it will be assessed after eight weeks
measure: alkaline phosphatase
timeFrame: it will be assessed after eight weeks
measure: triglycerides
timeFrame: it will be assessed after eight weeks
measure: body mass index
timeFrame: it will be assessed after eight weeks
Other outcomes:
Locations:
city: Dokki
country: Egypt
facility: Cairo University
state: Giza
Study officials:
affiliation: Cairo University
name: Ali Ismail, lecturer
role: STUDY_CHAIR
References:
Clinical trial NCT01894542: A Study of the Effects of Intake of Two Cod Residual Meals on Glucose Regulation in Overweight and Obese Adults
Official title: An 8 Week Study to Compare the Effects of Two Combinations of Water Soluble and Non-water Soluble Cod Residual Meals on Glucose Regulation in Overweight and Obese Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Lead sponsor: University of Bergen
Sponsor class: OTHER
Collaborators: name: Granit AS Transport & Tourism
name: Norwegian Seafood Center
name: Nofima
First posted: 2013-07-10
Enrollment: 55
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators have previously shown the intact protein from cod filet improves glucose regulation and serum lipid profile in overweight adults. A large amount of trimmings from various fish species such as cod is thrown away or sold at very low prices for animal feed, and analyses of the amino acid composition reveals that this can be a good protein source for humans. Two fractions are normally isolated from intact fish meal, i.e. water soluble and non-water soluble proteins. In the present study the investigators will compare these fractions, by studying their effects on glucose regulation in overweight/obese adults.

Detailed description: Participants receive 6g per day of water soluble on non-water soluble cod protein as tablets for 8 weeks.

Eligibility criteria: Inclusion Criteria:

* BMI\>28
* healthy
* fasting blood glucose \<7.0 mmol/L
* stable body weight with less than 5 kg fluctuation during the last 4 months

Exclusion Criteria:

* known disease or metabolic disturbances related to overweight or obesity
* use of prescription medications that affect blood glucose, blood lipids or inflammatory status
* allergies towards fish or seafood
* undertaking a weight loss diet
* tobacco use exceeding \>15 cigarettes/day
* pregnancy or breastfeeding
* high seafood consumption
* use of dietary supplements including cod liver oil or other marine fatty acids
* allergies towards fish, milk, egg

Primary outcomes:
measure: Glucose tolerance
timeFrame: 8 weeks
Secondary outcomes:
measure: Gene expression
timeFrame: 8 weeks
measure: Amino acids and amino acid metabolites
timeFrame: 8 weeks
measure: Comparisons of metabolites and co-factors involved in one-carbon metabolism in serum and urine
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: University of Bergen
Study officials:
References:
citation: Vikoren LA, Nygard OK, Lied E, Rostrup E, Gudbrandsen OA. A randomised study on the effects of fish protein supplement on glucose tolerance, lipids and body composition in overweight adults. Br J Nutr. 2013 Feb 28;109(4):648-57. doi: 10.1017/S0007114512001717. Epub 2012 May 31.
Clinical trial NCT05360342: Incorporation of Vitamin K Into Uremic Lipoproteins
Official title: Incorporation of Vitamin K Into Uremic Lipoproteins
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin K Deficiency
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2022-05-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Chronic kidney disease (CKD) patients have an increased cardiovascular risk with corresponding cardiovascular calcifications. CKD patients exhibit a functional vitamin K deficiency. Calcification can be prevented by vitamin K intake. The aim of this study is to investigate the cause for the vitamin K deficiency beyond a diminished dietary vitamin K uptake.

Detailed description: This study is a monocentric, 1-armed interventional trial. Participants will be recruited at the University Hospital of the RWTH Aachen.

We will analyse serially collected serum from 10 dialysis patients, after ingestion of a single vitamin K supplement, compared to healthy controls. Lipoprotein fractions will be isolated and the corresponding vitamin K contents will be measured by chromatography.

The vitamin K supplement contains 3 subforms of vitamin K: vitamin K1 (1000µg), menaquinone-4 (1000µg) and menaquinone-7 (200µg).

Eligibility criteria: Inclusion criteria

* Age ≥ 18 years
* Controls: adequate kidney function (GFR \> 60 ml/min/1,73m2)
* Patients: chronic haemodialysis
* Written consent to take part in the study

Exclusion criteria

* Intake of vitamin K antagonists
* gastro-intestinal diseases interfering with vitamin K intake
* profound anemia with an Hb \< 10 g/dl
* judicial or official commitment to an institution
* pregnancy and lactation

Primary outcomes:
measure: Vitamin K content in lipoproteins
timeFrame: 1 year
Secondary outcomes:
measure: PIVKA-II levels
timeFrame: 1 year
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: RWTH Aachen University
Study officials:
affiliation: RWTH Aachen University
name: Jürgen Floege, MD
role: PRINCIPAL_INVESTIGATOR
References: