louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03925571: Musicotherapy in Reducing Peroperative Anxiety and Post-surgical Pain in Dental Care
Official title: Evaluation of the Effectiveness of Musicotherapy in Reducing Peroperative Anxiety and Post-surgical Pain in Dental Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Pain and Sensation Disorders
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
Collaborators: name: Fondation Apicil
First posted: 2019-04-24
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The main purpose of MUSANX study is to highlight analgesic effectiveness of musicotherapy in post-surgical periodontal and implant; and to measure its per-operative anxiolytic effectiveness

Detailed description: This study will be on music use as musicotherapy "receptive " or " passive ", using hearing aid for listening in order to relax and reduce the anxiety and pain state of the patient. This care will be focused on the acute stress and pain during the dental care.

Another major secondary purpose will consist to explore the anxiolytic effect of the musicotherapy on diverse stress markers such as heart rate, respiratory rate, salivary cortisol ratio and electro-dermal intensity (RED).

Eligibility criteria: Inclusion Criteria:

* Majors aged between 18 and 55 years, with an appropriate hearing and able to use Music-Care© (selection of the playlist via internet access),
* Needing treatment in odontology - periodontal surgery (coronary elongation or sanitation surgery or muco-gingival surgery) or implantary surgery (placement of an unit implant or two implant in the same localization),
* Oral and dated consent,
* Agreeing to be contacted via phone at J+1 and to fill follow-up study documents,
* Profiting of social security or CMU.

Exclusion Criteria:

* Patients with a long-term taking of anxiolytic or analgesic,
* Regular consumer of soft drug (cannabis) or hard drug (opioid),
* Patient with medical history of psychiatry (mental harm), hearing problem, cognitive and behavioural impairment (claustrophobia), sensory disabilities,
* Patient with problems of hemostasis,
* Majors under trusteeship or guardianship,
* Pregnant women or lactating,
* Minors,
* Protected person, deprived of freedom or under justice safeguard,
* Profiting of a medical help from government (AME),
* Not contactable after care,
* Patient with hepatic impairment,
* Patient with dry mouth,
* Patient relevant a suboptimal hearing incompatible with musicotherapy or inability to use Music-care®.

Primary outcomes:
measure: Pain intensity
timeFrame: 24 hours after the dental surgery
Secondary outcomes:
measure: Efficacy of musicotherapy
timeFrame: 24, 48 and 72 hours
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
Study officials:
affiliation: Nantes University Hospital
name: Assem Soueidan, Pr
role: STUDY_CHAIR
affiliation: Nantes University Hospital
name: Olivier Bonnot, Pr
role: STUDY_DIRECTOR
References:
Clinical trial NCT05603871: Ligamentoplasty of Ligamentum Tere Developmental Dysplasia of the Hip
Official title: The Role of Ligamentoplasty of Ligamentum Tere in the Management of Developmental Dysplasia of the Hip
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Orthopedic Disorder
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2022-11-03
Enrollment: 3
Sex: ALL
Minimum age (years): 9
Maximum age (years): 3
Standard ages: CHILD
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients will be examined for:

Length of both lower limbs in relation to each other. Length of both lower limbs according to patient age. Presence of hump related to the outer surface of the hip Presence of pain, abnormal gait, Trendlenburg test Radiographic evaluation (antero posterior and frog pelvis views)

An addition to the steps of the open reduction, the following were done:

Identification of ligamentum teres and ligamentoplasty

Brief summary: The hip is formed by the acetabulum, the proximal femur and soft tissues joining them (capsule, teres ligament, transverse ligament and pulvinar). The acetabulum is a complex structure in the growing child. It is formed by the joined pubis, This junction is called tri radiate cartilage, which is responsible for acetabular growth. The external surface of the acetabulum is covered by a horse shoe-shaped articular cartilage. The transverse ligament joins both extremes of the articular cartilage inferiorly.


Eligibility criteria: Inclusion Criteria:

* Patient with Developmental dysplasia of the hip (DDH) with :

  * Age: from 9 months -3 years old.
  * Virgin DDH.
  * Failed closed reduction in the management of DDH.
  * Failed open reduction through medial approach in the management of DDH.

Exclusion Criteria:

* • Paralytic hip dislocation .

  * Post septic hip dislocation.
  * Traumatic hip dislocation .
  * Age : below 9 months or above 5 years.
  * Refusal to participate in this study.

Primary outcomes:
measure: modified Harris Hip Score
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Zhang S, Doudoulakis KJ, Khurwal A, Sarraf KM. Developmental dysplasia of the hip. Br J Hosp Med (Lond). 2020 Jul 2;81(7):1-8. doi: 10.12968/hmed.2020.0223. Epub 2020 Jul 6.
citation: Schaeffer EK, Study Group I, Mulpuri K. Developmental dysplasia of the hip: addressing evidence gaps with a multicentre prospective international study. Med J Aust. 2018 May 7;208(8):359-364. doi: 10.5694/mja18.00154.
Clinical trial NCT00273871: Study Comparing Conversion From Calcineurin Inhibitors to Rapamune Versus Standard Therapy in Established Renal Allograft Recipients
Official title: A Multi-centre, Randomized, Open-label, Study to Compare Conversion From Calcineurin Inhibitors to Rapamune Versus Standard Therapy in Established Renal Allograft Recipients on Maintenance Therapy With Mild to Moderate Renal Insufficiency.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Graft Rejection
Kidney Failure
Kidney Transplantation
Keywords: kidney transplant
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2006-01-09
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine the effect of conversion from calcineurin inhibitor based therapy to Rapamune based therapy in patients with mild to moderate renal insufficiency.


Eligibility criteria: Inclusion Criteria:

* Age over 18
* Treatment with a calcineurin inhibitor
* Patients with mild to moderate renal insufficiency

Exclusion Criteria:

* Patients with acute rejection
* Patients who received a transplant more than 10 years ago

Primary outcomes:
measure: Difference between treatment groups in renal function at 12 months.
Secondary outcomes:
measure: Incidence of acute rejection, patient and graft survival at 12 months, labs and physical examinations, quality of life etc.
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
affiliation: For United Kingdom and Ireland, ukmedinfo@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03766971: Influence of Tobacco Use on Cannabis Use
Official title: Influence of Tobacco Use on Cannabis Use
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE2
Conditions: Cannabis Use
Tobacco Use
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2018-12-06
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The effects of 7- and 21-days of tobacco cessation on cannabis relapse in daily cigarette-smoking, cannabis smokers will be compared, with half the participants in each group initiating tobacco cigarette smoking early (\<16 years) and the other half later (\>=16 years).
Primary purpose: OTHER

Brief summary: Cannabis smokers who also smoke tobacco cigarettes have markedly higher rates of cannabis relapse relative to those who do not use tobacco. There is a clear need to develop and evaluate interventions for dual tobacco and cannabis users. The investigators of this study have previously shown that the co-use of tobacco cigarettes contributes to the maintenance of daily cannabis use, and that age of cigarette onset is a critical predictor of treatment outcome. Short-term tobacco cessation may suffice in altering cannabis relapse rates in later-onset cigarette smokers, while a longer period of tobacco cessation may be needed for earlier-onset smokers. In the current study, a human laboratory model will be utilized to determine whether cannabis relapse varies as a function of tobacco cessation duration and age of tobacco use onset.


Eligibility criteria: Inclusion Criteria:

* Males and non-pregnant females aged 18-60 years old
* Use cannabis
* Smoke tobacco cigarettes
* Medically and psychologically healthy

Exclusion Criteria:

* Regular drug use other than cannabis
* Current pregnancy/lactation

Primary outcomes:
measure: Cannabis self-administration
timeFrame: During 9-day inpatient phase
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
References:
Clinical trial NCT04848571: Effects of Chinese Medicine on Early Pregnant Women
Official title: Effects of Chinese Medicine on Early Pregnant Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnant Women
Lead sponsor: Shanghai Meiji Health Science and Technology Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Shanghai Institute of Palnned parenthood research
First posted: 2021-04-19
Enrollment: 45
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 17 patients in contol group and 28 patients in the Chinaese medicine intervention group

Brief summary: From April 2021 to December 2021, 45 pregnant women who received intro fertilization-embyro transfer (IVF-ET) were recuited. According to their own wishes, 28 of them took Chinese medicine from the 2nd week after embryo transfer (intervention group), while the remaining 17 did not intake Chinese medicine (control group). Blood and feces samples were collected in the early morning of the 4th week after embryo transfer to detect 16S DNA sequences in feces, plasma metabolites, and whole blood transcriptomics.

Detailed description: Investigators planned to performed a observational clinical trial to determine the effects of the Chinese medicine (Gushen Antai recipe) including mainly Rehmannia glutinosa used in pregnant women for fetal protection. Two groupswere recruited, Chinese medicine intervention group and control group without Chinese medicine. In the 4th week after embryo transfer, blood and fetal were sampled for metabolic and intestinal microbiota analysis.

Eligibility criteria: Inclusion Criteria:

* recieved IVF
* childbirth without miscarriage
* taking vitamins during pregnancy

Exclusion Criteria:

* miscarrige
* missed sampling in the fourth week of pregnancy
* not appropriate judged by the doctor

Primary outcomes:
measure: 16s DNA analysis in feces
timeFrame: the fourth week in early pregnancy
Secondary outcomes:
measure: plasma metabonomics analysis by GC/LC mass
timeFrame: the fourth week in early pregnancy
Other outcomes:
measure: whole blood transcriptomics analysis by RNA sequencing
timeFrame: the fourth week in early pregnancy
Locations:
city: Shanghai
country: China
facility: Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Study officials:
affiliation: Shanghai Institute of Planned Parenthood Research
name: Enuo Liu, Dr.
role: STUDY_CHAIR
References:
Clinical trial NCT05737771: To Compare the Pharmacokinetic Characteristics of the Fixed-dose Combination Compared to the Loose Combination
Official title: A Phase 1 Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic Characteristics of the Fixed-dose Combination of DWJ1563 Compared to the Loose Combination of DWP16001 and DWC202213
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: FDC
Diabetes Mellitus, Type 2
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2023-02-21
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To compare the safety and pharmacokinetic properties between the administration of DWP16001 and DWC202213 as an individual drug, and the administration of DWJ1563 as a combination drug.


Eligibility criteria: Inclusion Criteria:

1. Before participating in the clinical trial, a person who fully explained the purpose, content, and characteristics of the clinical trial drug and signed a written consent form approved by the IRB of Chungbuk University Hospital to participate in this study according to his free will.
2. Healthy adults aged 19 or older at the time of screening.
3. Those who weigh more than 50.0 kg in men and women, and have a body mass index (BMI) of 18.0 kg/m2 or more and less than 30.0 kg/m2 or less in women.

   * Body mass index (BMI) = Weight (kg) / \[Height (m)\] 2.

Exclusion Criteria:

1. A person with a clinically significant history in liver, kidney, neuropsychiatric system, respiratory system, endocrine system, blood and tumor system, cardiovascular system (including orthostatic hypotension), digestive system, musculoskeletal system, etc.
2. A history of gastrointestinal diseases (e.g., esophageal diseases such as Crohn's disease, esophageal achalasia, or esophageal stenosis) or surgery (except appendectomy, hernia).
3. Those who are hypersensitive to other drugs (DPP-4 inhibitors, etc.) or have a history of clinically significant hypersensitivity reactions, including DWP16001, DWC202213 and homogeneous (SGLT2 inhibitors)
4. A person who shows the following results in the inspection items conducted during screening.

   * Blood ALT, AST, Total bilirubin \> twice the upper limit of the normal range.
   * The glomerular filtration rate (e-GFR) \<90 mL/min/1.73 m2 (using the CKD-EPI method)
5. After more than 3 minutes of rest, systolic blood pressure \> 150 mmHg or \<90 mmHg, or diastolic blood pressure \> 100 mmHg or \<60 mmHg, or pulse ≤ 40 bpm or ≥ 100 bpm in vital signs measured at the seat

Primary outcomes:
measure: AUC0-t of DWP16001
timeFrame: 0 to 24 hours
measure: Cmax of DWP16001
timeFrame: 0 to 24 hours
measure: AUC0-t of DWC202213
timeFrame: 0 to 24 hours
measure: Cmax of DWC202213
timeFrame: 0 to 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Cheongju-si
country: Korea, Republic of
facility: Chungbuk National University Hospital
state: Seowon-gu
Study officials:
References:
Clinical trial NCT04409171: Glucose Metabolism After Partial Pancreatectomy
Official title: Alteration of Glucose Metabolism After Partial Pancreatectomy Assessed With Biochemical Markers :A Single Center Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatectomy; Hyperglycemia
Diabete Mellitus
Keywords: Pancreatectomy
Diabetes Mellitus
pancreaticoduodenectomy
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2020-06-01
Enrollment: 224
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients receiving partial pancreatectomy

Brief summary: This is a single center observational study to assess alteration of glucose metabolism after pancreatectomy.

Detailed description: Biochemical markers of glucose metabolism including oral glucose tolerance tests, fasting blood glucose, insulin, glucagon and HbA1c were performed on patients receiving pancreatectomy (pancreaticoduodenectomy and distal pancreatectomy). Tests were done preoperatively, postoperatively at 3 months, and at 1 year. The primary endpoints were the incidence and risk factors of new-onset and worsened DM after each type of pancreatectomy.

Eligibility criteria: Inclusion Criteria:

* partial pancreatectomy

Exclusion Criteria:

* total pancreatectomy
* incomplete testing
* follow-up loss
* death within 1 year

Primary outcomes:
measure: incidence & risk factors of new-onset DM
timeFrame: at 1 year
measure: incidence & risk factors of worsened DM
timeFrame: at 1 year
Secondary outcomes:
measure: characteristics of new-onset and worsened DM
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
citation: Lee BW, Kang HW, Heo JS, Choi SH, Kim SY, Min YK, Chung JH, Lee MK, Lee MS, Kim KW. Insulin secretory defect plays a major role in the development of diabetes in patients with distal pancreatectomy. Metabolism. 2006 Jan;55(1):135-41. doi: 10.1016/j.metabol.2005.08.005.
citation: Hwang HK, Park J, Choi SH, Kang CM, Lee WJ. Predicting new-onset diabetes after minimally invasive subtotal distal pancreatectomy in benign and borderline malignant lesions of the pancreas. Medicine (Baltimore). 2017 Dec;96(51):e9404. doi: 10.1097/MD.0000000000009404.
Clinical trial NCT03687671: Long-term Effects of AAT in Patients With ABI
Official title: Long-term Effects on Socioemotional Skills of Animal-assisted Therapy in Patients With Acquired Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acquired Brain Injury
Lead sponsor: Swiss Tropical & Public Health Institute
Sponsor class: OTHER
Collaborators: name: Rehab Basel
name: University of Basel
First posted: 2018-09-27
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate weather patients treated with animal-assisted therapy show better socioemotional skills compared to treatment as usual.

70 patients will be allocated randomly to one of two groups (control group and intervention group). During 6 weeks, all patients get two therapy sessions (AAT vs. TAU) per week. The 35 patients in the control group will get treatment as usual (TAU) in speech therapy, occupational therapy or physiotherapy twice a week whereas the 35 patients in the intervention group will get the same therapies but there will be an animal included in the therapy sessions.

The main outcome is the amount of expressed emotion and interaction in a standardized social situation measured via behavioral video coding.

Measurements will be done before the first therapy session (pre-measurement, t0) and after the last therapy session (post-measurement, t1) of the 6 weeks of intervention. The follow-up measurement will be done 6 weeks (follow-up I, t2) and 12 weeks later (follow-up II, t3).


Eligibility criteria: Inclusion Criteria:

* Informed consent as documented signed by the patient or his/her legal representative
* Inpatients of REHAB Basel with acquired brain injury and FIM-score over 60 (Funktionale Selbstständigkeitsmessung, Internationale Vereinigung für Assessment in der Rehabilitation, 1997)
* Minimum age of 18 years

Exclusion Criteria:

* Enrolment of the investigator, his/her family members, employees and other dependent persons
* medical contraindications for contact with animals as allergy, phobia etc.

Primary outcomes:
measure: socioemotional behaviour
timeFrame: 18 weeks
Secondary outcomes:
measure: Social cognition
timeFrame: 18 weeks
measure: Therapy motivation
timeFrame: 18 weeks
measure: Quality of life score
timeFrame: 18 weeks
measure: Depression
timeFrame: 18 weeks
measure: Adherence to treatnemt
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: REHAB Basel
state: BS
Study officials:
References:
Clinical trial NCT01579071: Efficacy and Safety of CO2 vs Room Air Insufflation During ESD for Gastric Tumor
Official title: A Randomized, Controlled, Double-blind Trial of the Efficacy and Safety of CO2 vs Room Air Insufflation During ESD for Gastric Tumor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gastric Tumor
Lead sponsor: Gachon University Gil Medical Center
Sponsor class: OTHER
First posted: 2012-04-17
Enrollment: 110
Sex: ALL
Minimum age (years): 19
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Insufflation is essential procedure to observe the lumen of gastrointestinal tract in gastroscopy or colonoscopy Currently, most of hospital in Korea are using room air for insufflation According to recent clinical studies have shown that carbon dioxide have better safe and reduce stomachache than room air when endoscopy and endoscopic procedure is performed.

However, there was still no research data or study in Korea. In this study, the investigators will try to make comparison between Carbon dioxide and room air insufflation for endoscopic submucosal dissection for Gastric Tumor and investigate the efficacy and safety


Eligibility criteria: Inclusion Criteria:

* Patients who have gastroscopy and colonoscopy or ESD for gastric tumor under sedation in department of gastroenterology, Gachon University Gil Medical Center

Exclusion Criteria:

* Age : \< 19 years old
* Underlying disease : COPD requiring O2
* Known CO2 retention
* Opiate abuse for chronic pain
* Nonreader or short in understanding
* Pregnancy
* Any medical instabilities expected to not be in safe

Primary outcomes:
measure: Abdominal pain related to each insufflation
timeFrame: 1 day
Secondary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: 1 day
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center Department of Gastroentorology
Study officials:
References:
citation: Kim SY, Chung JW, Park DK, Kwon KA, Kim KO, Kim YJ. Efficacy of carbon dioxide insufflation during gastric endoscopic submucosal dissection: a randomized, double-blind, controlled, prospective study. Gastrointest Endosc. 2015 Dec;82(6):1018-24. doi: 10.1016/j.gie.2015.05.043. Epub 2015 Jul 2.