louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06425913: Effects of Cold and Kinesio Taping in Individuals With Rotator Cuff Tendonitis
Official title: Short-Term Effects of Cold Therapy and Kinesio Taping on Pain and Upper Extremity Functionality in Individuals With Rotator Cuff Tendonitis: A Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Tendinitis
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2024-05-23
Enrollment: 52
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Rotator cuff tendonitis (RCT) is one of the most common shoulder pathologies, causing pain, limitation of shoulder joint movements, and impaired function. Patient education, medical treatment, corticosteroid injections, physiotherapy rehabilitation approaches are the most common treatment options applied to alleviate the symptoms of RCT. Despite these various treatment methods, there are currently no specific guidelines regarding the most appropriate and effective intervention for RCT treatment. This is mainly because adequate, high-quality studies are lacking in RCT management. To the best of our knowledge, no studies have evaluated the effects of Kinesio Taping (KT), which has become a popular approach in recent years, and Cold Therapy (CT), which has often been used as a therapeutic agent since immemorial, on individuals with RCT. In this regard, this study aimed to investigate and compare the short-term effects of KT and CT on pain and upper extremity functionality in individuals with RCT.


Eligibility criteria: Inclusion Criteria:

* RCT diagnosis
* Excluding other shoulder pathologies by magnetic resonance imaging (MRI) and specific tests

Exclusion Criteria:

* Glenohumeral joint dislocation/subluxation;
* Acromioclavicular sprain;
* Rotator cuff tear;
* Glenohumeral joint instability;
* Calcific tendinitis of the shoulder;
* Acromioclavicular joint pathologies,
* Hyperlaxity;
* Any fracture in the shoulder;
* Diabetes, thyroid and any vascular or rheumatologic disease;
* Glenohumeral joint deformities;
* Superior labrum anteroposterior (SLAP) lesion;
* Shoulder pain lasting more than six months;
* History of shoulder surgery;
* Intra-articular steroid injection

Primary outcomes:
measure: Pain intensity
timeFrame: At baseline and after three days of the applications
measure: Function
timeFrame: At baseline and after three days of the applications
measure: Function
timeFrame: At baseline and after three days of the applications
Secondary outcomes:
measure: Range of Motion
timeFrame: At baseline and after three days of the applications
measure: Grip strength
timeFrame: At baseline and after three days of the applications
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakıf University
Study officials:
References:
Clinical trial NCT00559013: Peri-Strips Dry (PSD) Veritas Collagen Matrix Staple Line Reinforcement for Colorectal Surgery
Official title: Peri-Strips Dry With Veritas Collagen Matrix Staple Line Reinforcement for Colorectal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: Staple line reinforcement
Staple line buttress
Anastomotic reinforcement
Lead sponsor: Baxter Healthcare Corporation
Sponsor class: INDUSTRY
Collaborators: name: Synovis Surgical Innovations
First posted: 2007-11-16
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Purpose of the study is to assess the utility of PSD Veritas as a staple line reinforcement to minimize the risk of leakage during or after colo-rectal surgery.

Detailed description: Study is designed as a prospective enrollment of patients undergoing open or laparoscopic colorectal surgery requiring the creation of an anastomosis. Patients who are scheduled for elective resection of the left, anterior and low anterior colon can be enrolled in the study.

Eligibility criteria: Inclusion Criteria:

* Patient must comply with follow-up evaluations
* Patient or representative must provide informed consent prior to enrollment
* Patient scheduled for elective surgical excision of the left, anterior or low anterior colon
* Patient must meet all criteria and be eligible to have open or laparoscopic colorectal surgery with primary anastomosis at one location

Exclusion Criteria:

* Crohns disease
* Emergency colorectal surgery for trauma, obstruction, ischemic bowel, perforated diverticulum and all other emergent diagnosis.
* Patients who have not had mechanical bowel preparation
* Patients with known documented sensitivity/allergy to bovine material
* Severe radiation damage to tissue
* Carcinomatosis or stage IV cancer
* BMI is 35 or greater
* Cancer at primary anastomosis site that cannot be excised
* Patients who require an ileo rectal anastomosis
* Surgery anticipated to include jejunostomy pouch
* Anticipated diverting stoma
* No anti adhesive barrier can be used around anastomotic site
* No multiple circular anastomosis
* Surgeons discretion to exclude any patient he/she feels would not have a safe anastomosis
* Patient life expectacny less than follow-up timeframe of study
* Pregnancy
* Patients currently enrolled in a study that competes for the same patient population

Primary outcomes:
measure: Number of Participants With Major Colorectal Related Adverse Events: Leak, Stricture and Hemorrhage.
timeFrame: Discharge and 1 Month post surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Burlington
country: United States
facility: Lahey Clinic
state: Massachusetts
city: St. Paul
country: United States
facility: Colon & Rectal Surgery Associates
state: Minnesota
Study officials:
affiliation: Colon & Rectal Surgery Associates
name: Richard Karulf, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05656313: PRINCE22 System Complete Performance Study
Official title: Feature Supporting Multitasking of Visual and Acoustical Objects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss, Bilateral
Hearing Loss, Unilateral
Lead sponsor: Sonova AG
Sponsor class: INDUSTRY
First posted: 2022-12-19
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigation proposes to compare a narrow reference beamformer to a novel beamformer approach, when the talker is not in front of the hearing aid user and in the presence of background noise. The beamformer effect will be determined in terms of speech intelligibility, listening effort and ability to multitask when the talkers are located on the side or in the back.


Eligibility criteria: Inclusion Criteria:

* Experienced (minimum use duration 6 months)
* Adult (minimum age: 18 years) hearing aid users,
* Written and spoken German,
* Ability to understand instruction,
* Ability to perform tests successfully
* Ability to describe listening experiences,
* Ability to attend to the appointments,
* Healthy outer ear,
* Moderat to severe Hearing
* Informed consent as documented by signature.

Exclusion Criteria:

* Clinical contraindications deformity of the ear (closed ear canal or absence of pinna),
* Known hypersensitivity or allergy,
* Not willing to wear the hearing aid,
* Fluctuating hearing that could influence the results.

Primary outcomes:
measure: Difference in speech intelligibility between the reference beamformer and the novel beamformer approach (percentage of correct responses in word recognition) in a noisy situation with speech from the side and from behind.
timeFrame: 4 weeks
Secondary outcomes:
measure: Difference in speech recognition threshold between the reference beamformer and the novel (mean value of 10 repetitions).
timeFrame: 4 weeks
measure: Difference in multitasking ability between the reference beamformer and the novel (1. Respond on two trigger words / 2. Respond on a target sign).
timeFrame: 4 weeks
measure: Difference in subjective speech intelligibility between the reference beamformer and the novel (subjects rate his/her perception of the presented speech).
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Oldenburg
country: Germany
facility: Hörzentrum Oldenburg gGmbH
state: Niedersachsen
Study officials:
affiliation: Sonova AG
name: Matthias Latzel
role: STUDY_DIRECTOR
References:
Clinical trial NCT02134613: 99mTc-anti-TNF-alpha Scintigraphy in the Evaluation of Inflammatory Processes Activity
Official title: 99mTc-anti-TNF-alpha Scintigraphy in the Evaluation of Inflammatory Processes Activity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Psoriatic Arthritis
Arthritis
Keywords: 99mTc-anti-TNF
Inflammation
Psoriatic arthritis
Rheumatoid arthritis
Lead sponsor: Universidade Federal do Rio de Janeiro
Sponsor class: OTHER
First posted: 2014-05-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Rheumatoid and psoriatic arthritis patients benefit from anti-TNF-α therapy, once it is effective in reducing joint and skin manifestations in 60-70% of patients with inflammatory articular joint and skin diseases. Thus, identifying the presence and amount of TNF-α in the joint or skin in these patients may help in guiding the course of treatment more efficiently. The investigators research group has developed a novel approach to label anti-TNF-α with technetium-99m. Here the investigators compare the results obtained with scintigraphy and MRI in rheumatoid and psoriatic arthritis. The 99mTc-anti-TNF-α scintigraphy might recognize the molecule involved in the inflammatory process and provide crucial information to help physicians taking decisions about the drugs to be used based on biological evidence and which are cost-effective and appropriate for the treatment of choice. It allows direct identification of the monoclonal antibody anti-TNF-α in the articular joints and skin while it also ensures that the drug has reached its therapeutic target. It also allows correlation between the presence of the drug and clinical responses.


Eligibility criteria: Inclusion Criteria:

* Rheumatoid Arthritis (RA) patients must have 1 joint with edema.
* Inflammatory lumbalgia
* ankylosing spondylitis
* Psoriatic arthritis with active disease and skin lesion

Exclusion Criteria:

* Patients that do not return to scintigraphy
* Pregnancy, Lactation, active infection, severe concomitant disease and medication allergy history

Primary outcomes:
measure: Percentage of Participants with 99mTc-anti-TNF-alpha joint and skin uptake
timeFrame: 1 week
Secondary outcomes:
measure: Percentage of Participants with decreased 99mTc-anti-TNF-alpha uptake after follow-up
timeFrame: 5 months
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Hospital Universitário Clementino Fraga Filho
state: RJ
Study officials:
affiliation: UFRJ
name: Bianca Gutfilen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alexandre DJA, Carmo CCM, Romeiro LD, Gutfilen-Schlesinger G, Amarante JLM Jr, de Souza SAL, Gutfilen B. 99mTc-antitumor necrosis factor-alpha scintigraphy for the detection of inflammatory activity in rheumatoid arthritis. Nucl Med Commun. 2021 Apr 1;42(4):389-395. doi: 10.1097/MNM.0000000000001333.
Clinical trial NCT03851913: The Impact on Survival of Neo-adjuvant Transarterial Chemoinfusion (TAI) for Patients With Beyond Milan Criteria BCLC Stage A/B Hepatocellular Carcinoma Who Underwent Hepatectomy
Official title: The Impact on Survival of Neo-adjuvant Transarterial Chemoinfusion (TAI) for Patients With Beyond Milan Criteria BCLC Stage A/B Hepatocellular Carcinoma Who Underwent Hepatectomy: A Random, Controlled, Stage III Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hepatocellular Carcinoma
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2019-02-22
Enrollment: 344
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To compare the impact on survival of neo-adjuvant TAI for patients with beyond Milan criteria BCLC stage A/B HCC who underwent hepatectomy.


Eligibility criteria: Inclusion Criteria:

* older than 18 years old and younger than 75 years;
* ECOG PS≤1;
* proven hepatocellular carcinoma according patological examination or EASL/AASLD diagnostic criteria;
* not previous treated for tumor;
* the tumor was diagnosed as BCLC stage A/B and beyond Milan criteria;
* no distant metastasis;
* the lab test could meet:

  * neutrophil count≥2.0×109/L;
  * hemoglobin≥100g/L;
  * platelet count≥75×109/L;
  * serum albumin≥35g/L;
  * total bilirubin\<2-times upper limit of normal;
  * ALT\<3-times upper limit of normal;
  * AST\<3-times upper limit of normal;
  * serum creatine\<1.5-times upper limit of normal;
  * PT≤upper limit of normal plus 4 seconds;
  * INR≤2.2;
* sign up consent.

Exclusion Criteria:

* cannot tolerate TAI or surgery;
* distant metastasis exits;
* known history of other malignancy;
* be allergic to related drugs;
* underwent organ transplantation before;
* be treated before (interferon included);
* known history of HIV infection;
* known history of drug or alcohol abuse;
* have GI hemorrhage or cardiac/brain vascular events within 30 days;
* pregnancy.

Primary outcomes:
measure: OS
timeFrame: From date of randomization until the date of death from any cause, assessed up to 60 months
Secondary outcomes:
measure: RFS
timeFrame: From date of randomization until the date of recurrence, assessed up to 60 months
measure: recurrence rate
timeFrame: 1 year, 2 year, 3 year, 5 year after surgery
measure: PFS
timeFrame: From date of randomization until the date of progression, assessed up to 60 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: SUN YAT-SEN University Cancer Center
state: Guangdong
Study officials:
References:
Clinical trial NCT06875713: Parenting for Lifelong Health Program in Kuwait
Official title: Parenting for Lifelong Health in Kuwait (DAYEM) - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Child Development
Parenting Behavior
Parenting Intervention
Child Mental Health
Keywords: Parenting interventions
positive parenting
child well-being
child maltreatment
Lead sponsor: Ministry of Health, Kuwait
Sponsor class: OTHER_GOV
First posted: 2025-03-13
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Parenting interventions play a crucial role in promoting positive parent-child interactions, which are fundamental to fostering child well-being. Over the years, substantial progress has been made in understanding the importance of these interactions, particularly in the context of early childhood development. Positive parent-child interactions lay the groundwork for various aspects of child development, including socioemotional skills, academic performance, and mental health. Evidence-based parenting programs have demonstrated strong effectiveness in promoting positive parenting and preventing child maltreatment. The Parenting for Lifelong Health (PLH) program has yielded positive outcomes in many countries. This project aims to culturally adapt the PLH program and conduct a randomized controlled trial (RCT) to assess its feasibility and effectiveness in Kuwait.


Eligibility criteria: Inclusion Criteria:

* A primary caregiver of children aged 2-9 years
* Over the age of 18.
* Kuwaiti
* Lives in Kuwait
* Speaks Arabic

Exclusion Criteria:

* Non-Arabic speakers
* Non-Kuwaitis
* Parent whose co-parent is participating in study
* Not resident of Kuwait
* Target child has mental disability or special needs
* Facilitator, supervisor, or caregiver contributor in the DAYEM program

Primary outcomes:
measure: Parenting and Discipline Strategies
timeFrame: three time points: pre-intervention, post-intervention (one week after the intervention ends ), and four months post-intervention
Secondary outcomes:
measure: Demographic and Social Information
timeFrame: pre-intervention
measure: Child Behavioral Concerns
timeFrame: three time points: pre-intervention, post-intervention (one week after the intervention ends ), and four months post-intervention
measure: Parenting Experience and Well-Being
timeFrame: three time points: pre-intervention, post-intervention (one week after the intervention ends ), and four months post-intervention
measure: Personal Mental Well-Being
timeFrame: three time points: pre-intervention, post-intervention (one week after the intervention ends ), and four months post-intervention
measure: Parenting Stress and Satisfaction
timeFrame: three time points: pre-intervention, post-intervention (one week after the intervention ends ), and four months post-intervention
Other outcomes:
Locations:
city: Safat
country: Kuwait
facility: Child Protection Office - Ministry of Health
Study officials:
References:
Clinical trial NCT06507813: Safety and Efficacy of ADC189 in Children 2-11 Years Old With Influenza
Official title: A Phase III, Multicenter, Randomized, Double-blind, Controlled Study to Evaluate Pharmacokinetics, Safety and Efficacy of ADC189 Tablets/Granules in Children 2-11 Years Old With Influenza
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Influenza Type A
Influenza Type B
Lead sponsor: Jiaxing AnDiCon Biotech Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2024-07-18
Enrollment: 165
Sex: ALL
Minimum age (years): 2
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: Currently, there is only one treatment which only need one single oral dose for influenza in children five years above (Baloxavir marboxil) in China. This study will test a medicine for influenza in children younger than 5 year of age to see if it is safe and effective.

This is a multicenter, randomized, double-blind, controlled Phase III clinical study.

The study evaluates the pharmacokinetics, safety and efficacy of ADC189 tablets/granules following a single oral dose in children aged 2 to 11 years with influenza.


Eligibility criteria: Key Inclusion Criteria:

* 1. Patients aged 2 to 11 years at screening, both sex;
* 2. Patients were diagnosed with Influenza A Vairus Infection/Influenza B Virus Infection.
* 3. Parents willing and able to comply with study requirements, under the judgment of investigators .
* 4. Onset of symptoms no more than 48 hours before presentation for screening.

Key Exclusion Criteria:

* 1. Patients with severe influenza.
* 2. Pregnant or breast-feeding females
* 3. Patients with acute respiratory infection, tympanitis, sinusitis, or acute asthma attack within 2 weeks before screening.
* 4. Presence of a chronic disease or illness that may indicate increased risk for influenza-related complications.
* 5. Other antiviral therapy is required during screening.

Primary outcomes:
measure: The safety of study drug, Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: From Day 1 up to 15 days
Secondary outcomes:
measure: Plasma Concentrations of ADC189 and ADC189-I07
timeFrame: From Day 1 up to 14 days, 4 time points.
measure: Time to Resolution of Influenza Symptoms
timeFrame: From Day 1 up to 14 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Children's Hospital,Capital Medical University
state: Beijing
Study officials:
References:
Clinical trial NCT03513913: Comparison of IVF and ICSI in Human IVF
Official title: Comparison of the Effect of Conventional IVF and ICSI Fertilization Method on Human IVF Treatment Outcome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infertility
Keywords: in vitro fertilization
intracytoplasmic sperm injection
fertilization
Assisted reproduction
Lead sponsor: Semmelweis University
Sponsor class: OTHER
First posted: 2018-05-02
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this prospective randomized clinical trial we plan to compare two fertilization method which are widely used during in vitro fertilization (IVF) treatment. Outcome of conventional IVF and intracytoplasmic sperm injection (ICSI) treatment will be compared in this study.


Eligibility criteria: Inclusion Criteria:

Infertile patients entering in vitro fertilization treatment At least 1 oocytes collected Semen sample is suitable for IVF and ICSI fertilization as well Number of oocytes collected is lower than 5 AND/OR female age is equal or more than 40 years

Exclusion Criteria:

Samen sample is not suitable for conventional IVF fertilization Previous conventional IVF treatment resulted in \<50% fertilization rate

Primary outcomes:
measure: Fertilization rate
timeFrame: 18 hours after insemination
Secondary outcomes:
measure: Embryo quality
timeFrame: 36 and 72 hours after fertilization
measure: Implantation rate
timeFrame: 4 weeks after embryo transfer
measure: Clinical pregnancy rate
timeFrame: 4 weeks after the embryo transfer
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Semmelweis University First Department of Obstetrics and Gynecology
Study officials:
affiliation: Semmelweis University First Department of Obstetrics and Gynecology, Budapest, Hungary
name: Peter Fancsovits, PhD
role: STUDY_CHAIR
affiliation: Semmelweis University First Department of Obstetrics and Gynecology, Budapest, Hungary
name: Janos Urbancsek, DSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Veterinary Science, Budapest, Hungary
name: Csaba Pribenszky, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Semmelweis University First Department of Obstetrics and Gynecology, Budapest, Hungary
name: Adam Lehner, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Semmelweis University First Department of Obstetrics and Gynecology, Budapest, Hungary
name: Zita Kaszás, BSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Klinikum Kempten Oberallgäu, Kempten, Germany
name: Miklós I Ács, MD
role: PRINCIPAL_INVESTIGATOR
References: