louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04228393: The Individualized Treatment of 6-mercaptopurine in Children With Acute Lymphoblastic Leukemia in China
Official title: The Individualized Treatment of 6-mercaptopurine in Children With Acute Lymphoblastic Leukemia in China
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Acute Lymphoblastic Leukemia, Pediatric
Keywords: acute lymphoblastic leukemia
6-mercaptopurine
children
individualized treatment
Lead sponsor: Shandong University
Sponsor class: OTHER
Collaborators: name: Institute of Hematology & Blood Diseases Hospital, China
name: Qianfoshan Hospital
name: Qilu Hospital of Shandong University
name: Children's Hospital of Hebei Province
name: The Affiliated Hospital of Qingdao University
First posted: 2020-01-14
Enrollment: 82
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: TREATMENT

Brief summary: The purpose of this study was to assess the efficacy and safety of individualized treatment of 6-mercaptopurine (6-MP) in Chinese children with acute lymphoblastic leukemia, and to investigate the dose-concentration-response (DER) relationship between thiopurine metabolites and adverse events. The individualized administration of 6-MP was established in Chinese children with acute lymphoblastic leukemia.

Detailed description: To inflict minimal pain on the child contributing blood samples, opportunistic sampling design was chosen to collect pharmacokinetic samples.

Eligibility criteria: Inclusion Criteria:

1. Confirmed diagnosis of acute lymphoblastic leukemia;
2. Age 1-18y at time of initial diagnosis;
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
4. Informed consent signed by the patients parents or guardians before initiation of the study.

Exclusion Criteria:

1. Ph-positive ALL, matrue B-cell ALL, BC-CML;
2. Secondary to immunodeficiency, second cancer；
3. Abnormal liver and kidney function;
4. Patients divided into intermediate or high risk groups according to the risk grouping criteria of the Chinese Children Cancer Group (CCCG) protocol-ALL 2015;
5. Patients who enrolled in another clinical trial;
6. Expected survival time less than the treatment cycle;
7. Patients with other factors that researcher considers unsuitable for inclusion

Primary outcomes:
measure: leukopenia
timeFrame: 6 weeks
measure: thiopurine-induced leukopenia
timeFrame: 6-weeks
Secondary outcomes:
measure: hepatotoxicity
timeFrame: 6 weeks
measure: 6-thioguanine nucleotides (6-TGN) concentrations in erythrocytes.
timeFrame: 3 months
measure: 6-methylmercaptopurine nucleotides (6-MMPN) concentrations in erythrocytes.
timeFrame: 3 months
Other outcomes:
Locations:
city: Tanjin
country: China
facility: State Key Laboratory of Experimental Haematology, Department of Paediatric Haematology, Institute of Haematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
state: Tianjin
Study officials:
affiliation: Shandong University
name: Wei Zhao, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04051593: Effects of Cervical Stabilization Exercise in Violinists With Chronic Neck Pain
Official title: Cervical Stabilization Exercises Improved Pain, Disability, and Physical Impairments in University Violinists With Nonspecific Neck Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Keywords: cervical stabilization exercise
Lead sponsor: National Cheng Kung University
Sponsor class: OTHER
First posted: 2019-08-09
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the influence of a 6-week cervical stabilization exercise program in university violin players with chronic nonspecific neck pain.


Eligibility criteria: Inclusion Criteria:

* duration of playing the instrument longer than 5 years
* practicing the violin more than 5 hours/week
* constant neck pain for more than 3 months or at least 2 pain episodes in the last 3 months

Exclusion Criteria:

* previous surgery in the neck and shoulder regions
* current participation in a structured exercises program
* current treatment for neck and shoulder pain
* red flags suggesting of cancer, infection, vascular insufficiency, and etc. during history taking
* neurological symptoms of the upper extremities during screening tests (e.g. Spurling test and upper limb tension tests)

Primary outcomes:
measure: Changes in self-reported neck pain: Numeric Rating Scale
timeFrame: Pre-test 1 (week 0), Pre-test 2 (week 4) and Post-test (week 10)
measure: Changes in neck disability
timeFrame: Pre-test 1 (week 0), Pre-test 2 (week 4) and Post-test (week 10)
Secondary outcomes:
measure: Changes in deep neck flexors function
timeFrame: Pre-test 1 (week 0), Pre-test 2 (week 4) and Post-test (week 10)
measure: Changes in cervical muscle endurance
timeFrame: Pre-test 1 (week 0), Pre-test 2 (week 4) and Post-test (week 10)
measure: Changes in cervical joint position sense
timeFrame: Pre-test 1 (week 0), Pre-test 2 (week 4) and Post-test (week 10)
measure: Changes in upper body posture
timeFrame: Pre-test 1 (week 0), Pre-test 2 (week 4) and Post-test (week 10)
Other outcomes:
Locations:
city: Tainan City
country: Taiwan
facility: National Cheng Kung University
Study officials:
affiliation: National Cheng Kung University
name: Yi-Ju Tsai, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05043493: Effect of PRP as Therapy for Shoulder Osteoarthritis
Official title: Effect of Platelet Rich Plasma Therapy for Shoulder Osteoarthritis :Double Blinded Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Osteoarthritis
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-09-14
Enrollment: 91
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with shoulder osteoarthritis are suffering from pain and disabilities which lead to difficulties in life. The presence of platelet-rich plasma as regenerative therapy which helps in healing of damaged tissues like ligaments and joint might be of great benefit in managing such conditions.

Detailed description: Primary and secondary osteoarthritis of the shoulder occurs due to destruction of the articular surface of the humeral head and glenoid , Patient mainly presented with pain and decreases in the range of motion .

Treatment of shoulder osteoarthritis is often controversial and is typically based on the patient's age, the severity of symptoms, and level of activity, radiographic findings, and medical comorbidities.

The new era of management include regenerative therapy ,Platelet-rich plasma (PRP) is one of the regenerative therapy that prove its effect as injections of a concentration of a patient's own platelets to accelerate the healing of injured tendons, ligaments, muscles and joints.

Eligibility criteria: Inclusion Criteria:

* Patient's age: From 21 years.
* Acute symptoms on a background of at least a 3-month history of chronic pain or swelling of the shoulder joint with radiological confirmed (X-ray or MRI)
* Mild or moderate osteoarthritis of the shoulder joint according to The Samilson-Prieto classification.
* Numerical Rating Scale for pain scores greater than five on a 10 scale

Exclusion Criteria:

* Under 21 years of age
* Severe osteoarthritis according to The Samilson-Prieto classification. (Figure 1)
* Neuropsychiatric disorders.
* Immunocompromised patients.
* Active infection or malignancy at the joint.
* Pregnancy and breastfeeding.
* Patients may have thrombocytopenia, bleeding disorders, or on anticoagulant therapy.
* Shoulder surgery within 3 months or inflammatory arthritis; previous infection of the shoulder joint.

Primary outcomes:
measure: Change in patient's pain score
timeFrame: 2 weeks after each injection
Secondary outcomes:
measure: change in the range of motion
timeFrame: 2 weeks after each injection
Other outcomes:
measure: change in the use of analgesic medication
timeFrame: 2 weeks after each injection
Locations:
city: Cairo
country: Egypt
facility: Ainshams University
Study officials:
affiliation: department of anesthesia ,ICU, and pain management ASU
name: Amr Abd Elfatah, proffeseor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00815893: The Feasibility of Dexmedetomidine for Awake Fiberoptic Nasal Intubation
Official title: Interventional Study of Dexmedetomidine for Sedating Anticipated Difficult Airway Patients Undergoing Awake Fiberoptic Nasal Intubation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Awake Fiberoptic Nasal Intubation
Keywords: Dexmedetomidine
Fiberoptic nasal intubation
satisfaction
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2008-12-31
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the feasibility of dexmedetomidine infusion for oral cancer patients undergoing awake fiberoptic nasal intubation. We hypothesized that a loading dose of intravenous dexmedetomidine before awake fiberoptic nasal intubation for oral cancer patients undergoing general anesthesia will provide adequate sedation and analgesia without respiratory depression and upper airway obstruction.

Detailed description: Case number: 60, ASA I-III oral cancer patients with limited mouth opening

Patients will be randomly allocated into three groups, Dex group received dexmedetomidine (1.0 mcg/kg) infusion, Control group received saline, and Propofol group received 1% Propofol administrated usng effect-site TCI.

Main outcome was evaluated by grading scores presenting conditions for nasal intubation, post-intubation and satisfaction.

Other analysed parameters included airway obstruction, hemodynamic changes, treatment for hemodynamics response, consumption time for intubation, amnesia level, and postoperative adverse events. All outcome measurements were classified by scoring systems.

Eligibility criteria: Inclusion Criteria:

* Head and neck cancer patients with limited mouth opening
* Undergoing awake fiberoptic nasal intubation for elective surgery

Exclusion Criteria:

* a history of severe bradycardia
* any type of A-V block in EKG
* heart failure
* liver cirrhosis
* thrombocytopenia
* coagulopathy

Primary outcomes:
measure: grading scores presenting conditions for nasal intubation
timeFrame: before and after intubation
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Hospital
Study officials:
affiliation: Kaohsiung Medical University
name: Koung-Shing Chu, Master
role: STUDY_DIRECTOR
References:
Clinical trial NCT06028893: REal-worLd vAlidaTION of PhotoPlehtysmoGraphy (for Atrial Fibrillation Detection)
Official title: A Real-World Validation Study of Intermittent Photoplethysmography Based Rhythm Monitoring for Atrial Fibrillation Detection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Atrial Fibrillation
Photoplethysmography
Single-lead ECG
Electrocardiogram
Digital Health
Lead sponsor: Ziekenhuis Oost-Limburg
Sponsor class: OTHER
First posted: 2023-09-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Mobile health solutions for rhythm monitoring (e.g. atrial fibrillation detection) using photoplethysmography (PPG) technology on a smartphone have been developed. This study validates the performance of a digital health application (FibriCheck®) using PPG technology on a smartphone against a single-lead ECG device (Kardia Mobile®).


Eligibility criteria: Inclusion Criteria:

* Subject is scheduled for an ablation procedure for AF, at least 4 weeks after the inclusion.
* Subject provides informed consent.
* Subject understands and agrees to comply with planned study procedures.
* Subject is able to perform measurements of the heart rhythm using the FibriCheck application at home.

Exclusion Criteria:

* Insufficient cognitive or comprehensive level of Dutch to participate to the trial.
* No access to a smartphone or unable to perform FibriCheck measurements at home.
* Pacemaker.

Primary outcomes:
measure: Sensitivity
timeFrame: Two months
measure: Specificity
timeFrame: Two months
measure: Overall accuracy (proportion of correct classifications)
timeFrame: Two months
Secondary outcomes:
measure: Positive predictive value
timeFrame: Two months
measure: Negative predictive value
timeFrame: Two months
measure: Sensitivity by heart rate interval
timeFrame: Two months
measure: Specificity by heart rate interval
timeFrame: Two months
measure: Accuracy by heart rate interval
timeFrame: Two months
measure: Proportion of PPG measurements of insufficient quality for rhythm analysis
timeFrame: Two months
measure: Proportion of ECG measurements of insufficient quality for rhythm analysis
timeFrame: Two months
measure: Proportion of PPG measurements of insufficient quality for rhythm analysis by heart rate interval
timeFrame: Two months
measure: Proportion of ECG measurements of insufficient quality for rhythm analysis by heart rate interval
timeFrame: Two months
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
state: Limburg
Study officials:
References:
Clinical trial NCT06447311: Assessing the Clinical Efficacy of Hyaluronic Acid Hydrogel in Papilla Augmentation: A Clinical Study.
Official title: Assessing the Clinical Efficacy of Hyaluronic Acid Hydrogel in Papilla Augmentation: A Clinical Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gingival Destruction
Lead sponsor: SVS Institute of Dental Sciences
Sponsor class: OTHER
First posted: 2024-06-07
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the effect of hyaluronic acid gel in papilla augmentation.

Detailed description: Assessing the clinical efficacy of Hyaluronic acid hydrogel in papilla augmentation: A clinical study.

In Test group, Hyaluronic acid hydrogel will be injected using a syringe into the interdental papillary deficiency site.

In Control group, saline placebo gel will be injected into the interdental papillary deficiency site using a syringe.

Eligibility criteria: Inclusion Criteria:

1. Non-smoking patients aged above 18 years.
2. Have at least one site with interdental papilla recession in the anterior region (central incisors, lateral incisors and canines) of the maxillary or mandibular jaws.
3. Class I or Class II papillary recession.
4. The distance from the contact point to alveolar bone crest ≥5mm.
5. No active periodontal diseases and good oral hygiene.

Exclusion Criteria:

1. spacing or crowding between the teeth to be treated,
2. abnormal tooth shape,
3. systemic diseases such as diabetes mellitus, hypertension or
4. conditions that alter the outcome of periodontal therapy.
5. Pregnant and lactating women and
6. tobacco users

Primary outcomes:
measure: Evaluation of papilla augmentation
timeFrame: Baseline to 6 months
Secondary outcomes:
measure: Assessment of plaque
timeFrame: baseline ,3months,6months
measure: Assessment of gingiva
timeFrame: baseline ,3months,6months
Other outcomes:
Locations:
city: Mahbubnagar
country: India
facility: SVS Institute of dental sciences
state: Telangana
Study officials:
References:
Clinical trial NCT06612411: B.Subtilis Attenuate Symptoms in Diarrhea-predominant Irritable Bowel Syndrome by Increasing Hypoxanthine Biosynthesis
Official title: Purine Starvation Driven by Host-microbiota Maladaptation Contributes to the Pathogenesis of Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Irritable Bowel Syndrome with Diarrhea
Purine Metabolism Disorder
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
First posted: 2024-09-25
Enrollment: 180
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective, single-blind, randomized parallel study to investigate whether B. subtilis could improve clinical symptoms of IBS-D patients. Patients are randomly assigned by envelope method. A senior gastroenterologist is responsible for prescribing medication. Researchers are blind to patients' medication. Participants with IBS are recruited and randomized to receive a 4-week administration of B. subtilis-based probiotics. Clinical symptoms and stool samples are collected before and after the trial.


Eligibility criteria: Inclusion Criteria:

Patients are diagnosed with IBS. IBS was diagnosed based on the Rome IV criteria. Subjects aged from 16-80 years old without any gut medical conditions like inflammatory bowel diseases, infectious diarrhea, colon tumors were included.

Exclusion Criteria:

Subjects who are taking any probiotics, PPIs, antibiotics or any drugs affecting uric acid levels for at least one month before the study.

Subjects who decline to participate into the study.

Primary outcomes:
measure: The score of IBS-SSS before and after intervention
timeFrame: 6 months
Secondary outcomes:
measure: The concentration of purine in the stool before and after intervention
timeFrame: 6 months
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jinling Hospital
city: Nanjing
country: China
facility: Jinling Hospital
Study officials:
References:
Clinical trial NCT00941811: Immunevasion of Human Papillomavirus (HPV) in Vulvar Intraepithelial Neoplasia 2/3 and Anogenital Warts and Efficiency and Mechanisms of Imiquimod Treatment
Official title: An Explorative, Single Center and Controlled Study to Analyze the Immune Escape Mechanisms of HPV-associated Lesions and to Evaluate the Efficiency and Mechanisms of Imiquimod Treatment of Vulvar Intraepithelial Neoplasias 2/3 (VIN) and Anogenital Warts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HPV
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2009-07-20
Enrollment: 5
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The occurance and clinical course of human papillomavirus (HPV)-induced lesions is largely determined by the nature of the cellular immune defense generated. Even tough both genital warts and vulvar intraepithelial neoplasia (VIN) are HPV-associated genital lesions they differ in their risk of malignant progression. Imiquimod (IMQ) is a topically applied Toll-like receptor (TLR) 7 agonist that has been approved for the treatment of superficial (pre-) carcinomas of the skin (basal cell carcinomas, actinic keratosis) and HPV-associated lesions (genital warts). It acts by activation of the immune system exerting anti-tumor and anti-viral properties. The aim of the study is to evaluate the mechanisms of IMQ treatment and to analyze the differences in HPV-affected and non affected tissue at cellular and molecular level as determined by immunofluorescence stainings and real time PCR, respectively.


Eligibility criteria: Inclusion Criteria:

* Female patients with histologically proven Vulvar Intraepithelial Neoplasia 2/3 and/or anogenital Condyloma acuminata
* Age 18-50
* Informed consent

Exclusion Criteria:

* Malignancy
* Pregnancy
* Therapeutic Immunosupression
* Severe systemic dermatologic disease

Primary outcomes:
measure: Analysis of Cellular and Molecular Mechanisms of Imiquimod tretament and differences in HPV afeected and non affected tissue at cellular and molecular level
timeFrame: 16 weeks
Secondary outcomes:
measure: Proportion of histological and clinical response to therapy after 16 weeks of IMQ therapy
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Stephan Polterauer
Study officials:
affiliation: Medical University of Vienna
name: Georg Stingl, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06232811: Mother-to-infant Bonding and Prematurity Are Associated With Sensory Processing at 12 Months of Age
Official title: Mother-to-infant Bonding and Prematurity Are Associated With Sensory Processing at 12 Months of Age
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preterm
Sensory Disorder
Attachment Disorder
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2024-01-31
Enrollment: 42
Sex: ALL
Minimum age (years): 12
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Preterm and term children aged 12 months

Brief summary: Establishing a strong bond between mother and infant is crucial for fostering healthy relationships in the future. This research sought to investigate the correlation between mother-to-infant bonding and sensory processing, as well as the connection between prematurity and sensory processing in 12-month-old infants.

Detailed description: At the age of four months, mothers will utilize the Mother-Infant Attachment Scale (MIBS) to evaluate the bonding between themselves and their infants. Subsequently, at 12 months old, the sensory processing abilities of the infants will be assessed using the Test of Sensory Functions in Infants (TSFI). The study will encompass both preterm and term-born children.

Eligibility criteria: Inclusion Criteria:

preterm children with a gestational age \<34 weeks Term children with a gestational age between 37 and 41 weeks

Exclusion Criteria:

* infants with chromosomal defects, metabolic or neuromuscular disease,
* hydrocephalus, cerebral palsy, congenital heart disease,

Primary outcomes:
measure: Mother-to-Infant Bonding Scale
timeFrame: 15 minutes
measure: Test of Sensory Functions in Infants
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Erzurum Technical University
Study officials:
References: