louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05546034: Nutrition Screening - Route to a More Practical Method
Official title: Nutrition Screening - Route to a More Practical Method
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Internal Medicine
Lead sponsor: University of Tartu
Sponsor class: OTHER
First posted: 2022-09-19
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In-patient in department of internal medicine

Brief summary: Observational study. Comparison of existing nutritional screening tools based on questionnaires with blood tests already performed on a routine basis.

No intervention undertaken.

Detailed description: Nutrition screening is of established benefit but is difficult to ensure in ordinary clinical practice. It is relatively labour intensive. The investigation aims to determine whether routinely collected laboratory data could provide comparable information without the need for personnel time. It is known that individual blood tests do not provide sufficient sensitivity or specificity but it is hypothesised that combinations of tests could do so.

Included subjects are those admitted to the University Hospital department of internal medicine. All are eligible other than those subject to protective isolation for infection control (COVID, etc). Data collection is in the form of questionnaires to permit the calculation of 3 tools widely used for screening for malnutrition and malnutrition risk, namely the Malnutrition Universal Screening Tool (MUST), the Nutrition Risk Screening 2002 (NRS-2002) and the Subjective Global Assessment (SGA). Nutritional status is documented by the patient's status according to the international definition provided by the Global Leadership Initiative on Malnutrition (GLIM).

The blood tests already performed on a routine basis are captured to go alongside the nutrition screening tools.

Analysis will aim to determine whether combinations of laboratory data can simulate or replicate the information provided by MUST and NRS2002.

Eligibility criteria: Inclusion Criteria:

In-patient in department of internal medicine

Exclusion Criteria:

Unable to complete questionnaire or in protective isolation

Primary outcomes:
measure: Evaluation of new nutrition risk screening tool (devised from 200 patients) by validation in 100 contemporaneous patients in comparison with established screening tools (MUST, NRS-2002 and SGA) and malnutrition defined by GLIM.
timeFrame: Within 6 months of completion of recruitment
Secondary outcomes:
measure: Validation of new score against GLIM
timeFrame: Within 6 months of completion of recruitment
Other outcomes:
Locations:
city: Tartu
country: Estonia
facility: Tartu Ülikooli Kliinikum
state: Tartumaa
Study officials:
References:
Clinical trial NCT06088134: Contrast-enhanced CT-based Deep Learning Model for Preoperative Prediction of Disease-free Survival (DFS) in Localized Clear Cell Renal Cell Carcinoma (ccRCC)
Official title: Urology Department of the First Affiliated Hospital of Chongqing Medical University
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Clear Cell Renal Cell Carcinoma
Prognostic Cancer Model
Recurrent Renal Cell Cancer
Lead sponsor: First Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2023-10-18
Enrollment: 800
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to urology departments at participating medical centres

Brief summary: This study aims to preoperatively predict DFS of patients with localised ccRCC using a deep learning prognostic model based on enhanced contrast CT images, validate it's predictive ability in multicentre data and compare it's predictive ability with traditional models.


Eligibility criteria: Inclusion Criteria:

* underwent partial/radical nephrectomies
* histologically diagnosed as ccRCC
* with complete clinical data and preoperative CT image data

Exclusion Criteria:

* with incomplete clinic-pathological data
* lack of preoperative contrast-enhanced CT images or the image quality was unsuitable for analysis
* who received pre-surgery neoadjuvant or adjuvant therapies
* with multiple renal tumors or/and had synchronous metastasis

Primary outcomes:
measure: disease-free survival (DFS)
timeFrame: recruitment occurred between June 2013 and March 2020
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Yingjie Xv
state: Chongqing
Study officials:
References:
Clinical trial NCT02887534: Evaluation of Efficacy and Safety of SPARC1401 in Acute Low Back Pain
Official title: A Randomized, Double-blind, Active and Placebo-controlled, Study of SPARC1401 in Subjects With Moderate to Severe Acute Low Back Pain
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Acute Muscle Pain
Lead sponsor: Sun Pharma Advanced Research Company Limited
Sponsor class: INDUSTRY
First posted: 2016-09-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A phase 2 randomized clinical trial to evaluate efficacy and safety of SPARC1401 at three dose levels in patients with acute low back pain


Eligibility criteria: Inclusion Criteria:

* Gives informed and written consent and is able to comply with all study assessments scheduled in the protocol
* Males or females aged 18 to 80 years (inclusive).
* Female subjects should be surgically sterile (bilateral tubal ligation at least 6 months prior to randomization, bilateral oophorectomy or hysterectomy performed) or if they are of child-bearing potential, should be willing to practice an acceptable method of birth control from screening to completion of study.
* Subjects will be considered eligible for this trial based on medical evaluation, electrocardiogram and laboratory values at screening, and laboratory values outside normal range considered of no clinical significance by the investigator

Exclusion Criteria:

* History or presence of clinically significant or uncontrolled cardiovascular, respiratory, neurological, psychiatric, hepatic, renal, gastrointestinal, hematological, or sleep disorder
* History or clinical signs or symptoms suggestive of stenosing peptic ulcer, pyloroduodenal obstruction, or inflammatory bowel disease
* History of diagnosis of cancer within 5 years prior to screening
* History of narrow-angle glaucoma, symptomatic prostatic hypertrophy, or bladder-neck obstruction

Primary outcomes:
measure: Rating for medication helpfulness on five point scale: 0 - poor, 1 - fair, 2 - good, 3 - very good, 4 - excellent
timeFrame: Day 4
Secondary outcomes:
measure: Rating for medication helpfulness on five point scale: 0 - poor, 1 - fair, 2 - good, 3 - very, 4 - excellent
timeFrame: Day 8
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06019234: Juvenile Systemic Sclerosis, a Retrospective Epidemiological Study on a French Cohort
Official title: Uvenile Systemic Sclerosis, a Retrospective Epidemiological Study on a French Cohort
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Juvenile Systemic Sclerosis
Keywords: Systemic Sclerosis
Juvenile Systemic Sclerosis
Immunosuppressive treatments
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2023-08-31
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Minor subject (\<18 years old) having a systemic sclerosis between 01/01/2012 and 30/06/2022.

Brief summary: Scleroderma is an inflammatory attack of the vessels leading to localized or multisystemic sclerosis. It is a rare autoimmune pathology in pediatrics.

The incidence in pediatrics is very low (about 4 per million according to an American) and therefore the data on the pathology very poor, especially on the therapeutic level.

The proposed immunosuppressive treatments are extrapolated from data in adults. The evolution of connectivity does not seem quite identical to the evolution of adult scleroderma, adaptation of treatments seems judicious. However, data on the evolution under therapy in children are still poor.

Complications related to the pathology, iatrogeny and diagnostic delay are the first causes of mortality from this pathology and deserve to be studied and if possible avoided.

The main hypothesis of the research being to bring together the experiences of the various reference and competence centers in France concerning the clinical presentation, management and follow-up of children with systemic sclerosis.


Eligibility criteria: Inclusion criteria:

* Minor subject (\<18 years old)
* Diagnosis of systemic sclerosis between 01/01/2012 and 30/06/2022.
* Subject (and/or his parental authority) who has not expressed, after being informed, his opposition to the reuse of his data for the purposes of this research.

Exclusion criteria:

- Subject (or his parents) having expressed his (their) opposition to participating in the study

Primary outcomes:
measure: The therapeutic response was evaluated by the EULAR DAS 28 -CRP
timeFrame: at 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Pédiatrie 1 - CHU de Strasbourg - France
Study officials:
affiliation: University Hospitals of Strasbourg
name: Ariane ZALOSZYC, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00387634: Safety and Long-term Evaluation (up to 5 Years) of First Booster Immunization With Novartis' TBE Vaccine for Adults in Adolescents and Adults
Official title: A Phase IV, Uncontrolled, Open-label, Single-center Study in Adolescents and Adults: Evaluation of Immunogenicity and Safety of the First Booster Immunization With Novartis' TBE Vaccine for Adults in Participants of Study V48P7 and Long-term Evaluation of Immunogenicity up to 5 Years After First Booster Immunization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tick Born Encephalitis
Keywords: tick born encephalitis, TBE, adults
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-10-13
Enrollment: 323
Sex: ALL
Minimum age (years): 15
Maximum age (years): 68
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: evaluate safety and immunogenicity of first TBE booster and long-term immunogenicity up to 5 years after first TBE booster


Eligibility criteria: Inclusion Criteria:

* healthy subjects who have completed study V48P7

Exclusion Criteria:

* acute illness at day of immunization
* general decrease in resistance
* progressive neurological disorders
* history of febrile or afebrile convulsions
* major congenital defects
* serious chronic illness
* hypersensitivity to study vaccine
* treatment with immunosuppressants or systemic corticosteroids, immunoglobulins, whole blood or plasma derivates

Primary outcomes:
measure: immunogenicity of TBE vaccine for adults when given as first booster dose as measured by neutralisation test and ELISA
timeFrame: On day 21, year 1, year 2, year 3, year 4, year 5
Secondary outcomes:
measure: safety of TBE vaccine for adults with respect to local and systemic reactions and adverse event reporting
timeFrame: Local and systemic reactions: up to Day 3 post vaccination; Adverse events: 21 days post vaccination; SAEs: throughout the study
Other outcomes:
Locations:
city: Hradec Kralove
country: Czech Republic
Study officials:
affiliation: Novartis
name: Novartis Vaccines - Information Services
role: STUDY_CHAIR
References:
citation: Beran J, Xie F, Zent O. Five year follow-up after a first booster vaccination against tick-borne encephalitis following different primary vaccination schedules demonstrates long-term antibody persistence and safety. Vaccine. 2014 Jul 23;32(34):4275-80. doi: 10.1016/j.vaccine.2014.06.028. Epub 2014 Jun 17.
Clinical trial NCT03973034: Clinical Application of ctDNA in Early Screening of Breast Cancer
Official title: Clinical Application of ctDNA in Early Screening of Breast Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Keywords: ctDNA
early screening
Copy Number Variants (CNV)
Low Depth Whole Genome Sequencing (LDWGS)
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2019-06-04
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Three groups: normal people, benign breast disease patients and breast cancer patients in early stage.

Brief summary: The investigators aim to evaluate the possibility of clinical application of ctDNA detection in peripheral blood of normal people, benign breast disease patients and breast cancer patients, so as to act as the new techniques or indicators of early screening of breast cancer.


Eligibility criteria: Inclusion Criteria:

* Written informed consent must be obtained and documented according to the local regulatory requirements prior to beginning specific protocol procedures.
* Age of at least 18 and at most 70 years.
* Normal people who works as the volunteers.
* Benign breast disease patients should be diagnosed with confirmed pathology after surgery.
* Breast cancer patients should be diagnosed with confirmed pathology after surgery, and with no clinical evidence of local recurrence or distant metastases. Complete staging work-up within 3 months prior to registration, which should be earlier than TNM IIA stage.
* Adequate organ function including normal red and white blood count, platelets, serum creatinine, bilirubin, and transaminases within normal range of the institution.

Exclusion Criteria:

* Known hypersensitivity reaction to the investigational compounds or incorporated substances.
* Local recurrence and/or metastasis of breast cancer.
* Pregnant or lactating patients. Patients of childbearing potential must have a negative pregnancy test (urine or serum) within 14 days prior to registration.
* Prior or concomitant secondary malignancy (except non-melanomatous skin cancer or carcinoma in situ of the uterine cervix).
* Other serious illness or medical condition that may interfere with the understanding and giving of informed consent and the conduct of the study.
* Concurrent treatment with other experimental drugs or any other anti-cancer therapy.
* Males.

Primary outcomes:
measure: ctDNA test model for early screening of breast cancer
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01555034: Movement Therapy and Childhood Obesity
Official title: The Effect of Movement Therapy on the Success in a Multidisciplinary Intervention for the Treatment of Childhood Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: obesity
movement therapy
exercise
behaviour
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2012-03-15
Enrollment: 26
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Child health and Sports Center, Meir Medical Center, has an intervention program to treat obese children. The program includes physical activity, nutritional intervention and behavioral treatment.The emphasis given in the center to physical activity and sport enables a strong connection with movement therapy. Movement therapy allows obese children to face and cope with the psychological and emotional aspects of obesity.

The purpose of this study is to evaluate the contribution of the movement therapy intervention to our program.

Detailed description: Movement therapy is part of the multidisciplinary intervention. Weekly one hour long sessions are conducted under the guidance of a certified therapists.

The meeting includes physical movement aimed to address the emotional world of the obese child. Using games, structured exercises and verbal processing.

At the start and end of the evaluation the children will answer questionnaires to study:

1. Behavioral questionnaires:emotional state: anxiety, depression, communication, self-esteem, quality of life and self-efficacy.
2. Demographic questions . At the beginning and the end of the program a certified movement therapist will observe the children to estimate the change of emotional movement.weight, height and BMI are measured regularly in the center.

Eligibility criteria: Inclusion Criteria:

* Overweight/obese children

Exclusion Criteria:

* Child that do not want to take part in this study

Primary outcomes:
measure: Emotional/behavioral changes
timeFrame: 3 MONTHS
Secondary outcomes:
measure: weight, height and BMI
timeFrame: 3 MONTHS
Other outcomes:
Locations:
city: Kfar-Saba
country: Israel
facility: Meir Medical Center
Study officials:
affiliation: Meir Medical Center
name: Dan Nemet, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01139034: A Pilot Study of Shoulder Subluxation Treatment by Using the Self-Designed Surface Functional Electrical Stimulator
Official title: Rehabilitation Robot for Upper Limbs, Component Project 2: Hybrid of FES and Rehabilitation Robot for Treatment of Shoulder Subluxation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Stroke
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2010-06-08
Enrollment: 3
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to investigate the effects of the self-designed surface functional electrical stimulator on shoulder joint subluxation for stroke patients

Detailed description: Functional electrical stimulation (FES) is a common and effective therapeutic approach for clinical treatments of shoulder subluxation. By applying low-frequency electrical stimulation to the target muscle groups, improvements may be observed in terms of muscle strength, subluxation, and passive humeral lateral rotation of the shoulder joint. In order to overcome issues regarding the integration of an FES and a rehabilitation robot, group members have designed a customized FES system approved by medical safety regulations. Despite sharing identical specifications with commercial models, the approved 2-channel FES system provides better integrity and control when working with the upper extremity rehabilitation robot. In this study, three patients with unilateral shoulder subluxation will be recruited. Limited shoulder x-ray photos shall be taken before, during, and after the FES shoulder subluxation treatment for studying the effects.

Eligibility criteria: Inclusion Criteria:

* stroke (1-3 months)
* Brunnstrom Stage I-III
* single, unilateral

Exclusion Criteria:

* aphasic
* shoulder impairment
* severe osteoporosis
* cardiac arrhythmias or having a pacemaker implanted
* abnormal cutaneous sensation at the target areas

Primary outcomes:
measure: Upward migration index
timeFrame: 1 year
Secondary outcomes:
measure: Acromiohumeral distance
timeFrame: 1 year
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Physical Medicine and Rehabilitation, NTUH
Study officials:
affiliation: Department of Physical Medicine and Rehabilitation, NTUH, Taipei, Taiwan
name: Jin-Shin Lai, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04148534: Compare the Operating Condition of Two Levels of Muscle Relaxation on Facial Nerve MEP Monitoring in CPA Surgery
Official title: Intraoperative Monitoring of Facial Nerve in Patients Undergoing Cerbellopontine Angle Tumer Resection Using Partial Versus no Neuromuscular Block
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebellopontine Angle Tumor
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Cairo University
First posted: 2019-11-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: compare the operating condition of two different levels of muscle relaxation on facial nerve monitoring using transcranial motor evocked potential in CPA surgery .

* To Estimate End to start facial nerve MEP amplitude ratio
* To determine the effect of neuromuscular relaxant degrees on recovery and
* Assessment of propofol doses needed for enhancement of early recovery and ambulation.

Detailed description: 40 Patients aged from 18-60 years old undergoing Cerebellopontine angle surgery. Patients will be one of two groups: Both Induction will be accomplished with fentanyl, propofol , rocronium infusion will be given randomly to one of the groups.

Depth of anaesthesia, neurotransmitter monitoring and facial nerve neurophysiological monitoring will be done.

Eligibility criteria: Inclusion Criteria:

* Patients age between \>18 and\<60.
* Patients scheduled for neurosurgical CPA surgeries
* Ability to sign the consent
* ASA classification I, II

Exclusion Criteria:

* ASA \> II
* Hemodynamically unstable
* Disease affecting neuromuscular transmission (myasthenia gravies ...etc.)
* GCS \< 15.
* Any cardiac patient (ischemic heart disease - cardiomyopathy...etc.)

Primary outcomes:
measure: End to start facial nerve MEP amplitude ratio.
timeFrame: 6 to 8 month
Secondary outcomes:
measure: number of hypotension episodes and the use of vasopressors
timeFrame: 6 to 8 month
measure: Total volume of propofol and fentanyl infused
timeFrame: 6 to 8 month
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo university medical school
Study officials:
affiliation: Cairo university faculty of medicine research ethical committee
name: Cairo university
role: PRINCIPAL_INVESTIGATOR
References: