louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00380601: PhaseⅢOpen-label Study of MRA for Rheumatoid Arthritis(RA)
Official title: An Open-label, PhaseⅢ Study to Evaluate the Efficacy and Safety of MRA in Patients With RA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Lead sponsor: Chugai Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2006-09-26
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An open-label, PhaseⅢ study to evaluate the efficacy and safety of MRA in patients with RA


Eligibility criteria: Inclusion Criteria:

* Diagnosed as having RA, on the basis of the criteria stipulated by the American Conference on Rheumatism(ACR) in 1987
* Active RA despite at least one DMARDs or immunosuppressants or Infliximab or Etanercept.Active disease is defined as having at least 6 tender and 6 swollen joints among DAS28 (Modified Disease Activity Scores that include twenty eight joint counts) and ESR at least 30 mm/hr or CRP not less than 2.0mg/dL
* Active RA despite over 10mg adrenocortical steroids within 2 weeks before entry of this study

Exclusion Criteria:

* Shown to have class-Ⅳ Steinbrocker's functional activity in an evaluation carried out within 4 weeks before administration of the study drug
* Treated with Infliximab within 3 months before and with Etanercept within 2 weeks before administration of the study drug
* Subjected to any of the following within 4 weeks before administration of the study drug:

  1. Surgical treatment (operations,etc.).
  2. Plasma exchange method

Primary outcomes:
measure: Frequency of ACR 20％ improvement at the final visit
timeFrame: throughout study
Secondary outcomes:
measure: Time course of the frequency of ACR 20％, 50％ and 70％ improvement,time course of individual items within the ACR core set.
timeFrame: throughout study
measure: Time course of DAS28 to the final visit.
timeFrame: throughout study
measure: Time course of steroid sparing effect from first visit to final visit.
timeFrame: throughout study
Other outcomes:
Locations:
city: Chugoku
country: Japan
facility: Chugoku region
city: Chukyo
country: Japan
facility: Chukyo region
city: Hokkaido
country: Japan
facility: Hokkaido region
city: Hokuriku
country: Japan
facility: Hokuriku region
city: Kansai
country: Japan
facility: Kansai region
city: Kanto
country: Japan
facility: Kanto region
city: Kousinetsu
country: Japan
facility: Kousinetsu region
city: Kyushu
country: Japan
facility: Kyushu region
city: Sikoku
country: Japan
facility: Sikoku region
city: Tohoku
country: Japan
facility: Tohoku region
Study officials:
affiliation: Chugai Pharmaceutical Co., Ltd. Research Dept.1
name: Yuji Kimura
role: STUDY_DIRECTOR
References:
Clinical trial NCT06612801: REThinkGame4training: Training Emotion Regulation Abilities Using an Online Therapeutic Game
Official title: REThinkGame4training: Training Emotion Regulation Abilities Using an Online Therapeutic Game
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emotion Regulation Abilities
Keywords: online game
therapeutic game
digital intervention
REThink game
emotion regulation abilities
irrationality
Lead sponsor: Babes-Bolyai University
Sponsor class: OTHER
First posted: 2024-09-25
Enrollment: 237
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To test the efficacy of the REThink therapeutic game in training emotion regulation abilities of children and adolescents.

Detailed description: The primary aim of this study is to evaluate the effectiveness of the REThink therapeutic game in training emotion regulation abilities in children aged 8 to 12 years. The participants will be recruitedfrom various schools and counties, ensuring a diverse sample. Those in the experimental group will engage with the REThink game over a four-week period. To assess the impact of the intervention, standardized pre-test and post-test measures will be administered, allowing for a comparison of mental health outcomes before and after the use of the therapeutic game. The study seeks to determine whether this digital tool can serve as an effective training for improving emotion regulation abilities in this age group.

Eligibility criteria: Inclusion Criteria:

* children and adolescents aged 8 to 12 years
* non-clinical levels of mental health symptoms on any SDQ subscale or total score
* parental consent provided

Exclusion Criteria:

* intellectual disability or physical limitations precluding the use of the online game
* does not have parental informed consent
* clinical or subclinical level on the SDQ measure, total score, or any subscale

Primary outcomes:
measure: Emotion regulation abilities
timeFrame: baseline assessment, one week before starting the intervention
measure: Changes in emotion regulation abilities
timeFrame: post-test assessment, one week after finishing the intervention
measure: Irrationality
timeFrame: baseline assessment, one week before starting the intervention
measure: Changes in irrationality
timeFrame: post-test assessment, one week after finishing the intervention
Secondary outcomes:
Other outcomes:
measure: Mental health symthoms
timeFrame: baseline assessment, inclusion criteria
Locations:
city: Cluj-Napoca
country: Romania
facility: Babes-Bolyai University
Study officials:
References:
Clinical trial NCT06157801: Evaluation of Hereditary Cancer Educational Videos
Official title: Evaluation of Hereditary Cancer Educational Videos
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hereditary Cancer
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2023-12-06
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The Harris Health System (LBJ Hospital)

Brief summary: To learn if educational videos can help participants be more informed about hereditary cancers (ones that run in the family).

Detailed description: Primary Objective

Determine the impact of educational videos on:

* Participant's hereditary cancer knowledge.
* Participant's confidence to share hereditary cancer information with family members.

Secondary Objective

* Determine impact of educational videos on participant's confidence to undergo hereditary cancer screening.
* Identify opportunities to tailor and improve the educational video's content, style, and understandability per participant preferences and feedback.

Eligibility criteria: Inclusion Criteria:

1. Participants of The Harris Health System Lyndon B. Johnson (LBJ) Hospital outpatient oncology clinics (i.e., Gynecologic Oncology, Medical Oncology).
2. 18 years of age or older.
3. Speaks and/or reads English or Spanish.
4. Has a pathogenic or likely pathogenic variant (mutation) in BRCA1, BRCA2, MLH1, MSH2, MSH6, PMS2, and/or EPCAM on germline genetic testing.
5. Has a documented genetic testing results disclosure encounter (i.e. telephone call, follow-up appointment).

Exclusion Criteria:

1. No longer receives outpatient care at LBJ Hospital at time of recruitment.
2. Has only a variant of uncertain significance in BRCA1, BRCA2, MLH1, MSH2, MSH6, PMS2, and/or EPCAM.
3. Has only a pathogenic or likely pathogenic variant in gene other than BRCA1, BRCA2, MLH1, MSH2, MSH6, PMS2, or EPCAM.
4. Is unwilling, unable, or requires a legally authorized representative to provide informed consent.

Primary outcomes:
measure: Hereditary Cancer Multidimensional Measure of Informed Choice Questionnaires
timeFrame: through study completion; an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Jose Rauh-Hain, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05831501: Postoperative Analgesic Efficacy of Trans Abdominis Plane Block
Official title: Postoperative Analgesic Efficacy of Trans Abdominis Plane Block in Women Undergoing Caesarean Section, a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Operative Pain
Cesarean Section Complications
Keywords: TAP block, C-section, Spinal anesthesia, localized field effects, analgesia, Postoperative pain and Opioids
Lead sponsor: Armed Forces Hospital, Pakistan
Sponsor class: OTHER
First posted: 2023-04-26
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Transverse abdominis plane (TAP) block is an effective method to manage postoperative pain in patients with midline abdominal wall incisions. It is used frequently in many lower abdominal surgeries however its use after caesarean section is still new, and fewer studies are available. We conducted this study to see the analgesic effect of TAP block after caesarean section.

Detailed description: The study is being conducted, at Combined Military Hospital Sargodha, Pakistan, to compare the analgesic efficacy of TAP block in providing post-caesarean analgesia with the control group, in terms of mean postoperative use of opioids after caesarean delivery. Sixty patients have been randomly selected using non-probability, consecutive sampling, and applying inclusion and exclusion criteria. The study design is a randomized controlled trial with thirty patients in each group undergoing elective caesareans. All patients will be given spinal anaesthesia with 1.5ml of 0.75% hyperbaric bupivacaine for a caesarean section. Patients in Group A will receive bilateral TAP block with 20ml of 0.25% bupivacaine while 20 ml of saline will be injected in patients of Group B on both sides of midline after caesarean section, in addition to intravenous ketorolac 8hrly. The intensity of pain, total opioid consumption, presence of vomiting, and sedation will be noted until 24 hours after the surgery.

Eligibility criteria: Inclusion Criteria:

* Elective Caesarean section
* ASA 1-3
* 20yrs to 45yrs

Exclusion Criteria:

* Emergency Surgery
* known allergy to local anaesthetic
* severe pre-eclampsia
* placenta accreta
* ASA 4
* Coagulopathy
* Hemodynamically unstable

Primary outcomes:
measure: Postoperative opioid consumption
timeFrame: 24 hours post cesarean section
Secondary outcomes:
measure: Pain intensity Score
timeFrame: from end of secarean section till 24 post operative hours
measure: Vomiting
timeFrame: Within 24hours after surgery
measure: Duration of First Rescue Analgesia
timeFrame: Within 24hours after surgery
Other outcomes:
Locations:
city: Sargodha
country: Pakistan
facility: Combined Military Hospital
state: Punjab
Study officials:
References:
Clinical trial NCT01226901: A Phase I Study of MK-4827 for Treatment of Solid Tumors (MK-4827-005)
Official title: A Phase I Study of MK-4827 in Patients With Solid Tumor
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Neoplasms
Solid Tumors
Keywords: Poly (ADP-ribose) polymerase (PARP) inhibitor
tumor
cancer
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2010-10-22
Enrollment: 3
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: This study will evaluate whether oral administration of MK-4827 to participants with advanced solid tumors is generally safe and well tolerated.


Eligibility criteria: Inclusion Criteria:

* Participant must have a histologically or cytologically-confirmed metastatic or locally advanced solid tumor that has failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy does not exist. There is no limit on the number of prior treatment regimens.
* Participant has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group(ECOG) Performance Scale
* Participant must have adequate organ function (per prespecified laboratory values).

Exclusion Criteria:

* Participant has had major surgery, chemotherapy, radiotherapy, hormonal or biological therapy within 4 weeks (6 weeks for nitrosoureas, mitomycin C, or bevacizumab) prior to entering the study.
* Participant has known central nervous system metastases or a primary central nervous system tumor.
* Participant is pregnant or breast feeding, or expecting to conceive or father children within the projected duration of the study.
* Participant is known to be Human Immunodeficiency Virus (HIV)-positive.
* Participant with active Hepatitis B or C.
* Participant has symptomatic ascites or pleural effusion.
* Participant has interstitial lung disease as a history or current evidence.
* Participant has known bleeding tendency or coagulation disorder as a history or current evidence, and/or participant is taking any anti-coagulant and/or antiplatelet therapies.
* Participant has uncontrolled persistent or active infection (acute infection which requires antibiotic or anti-fungal treatment).
* Participant has participated in a clinical trial with a known Poly (ADP-ribose) polymerase (PARP) inhibitor.

Primary outcomes:
measure: Incidence of dose-limiting toxicities (DLTs) in Cycle 1
timeFrame: Cycle 1 of treatment (1 cycle = 21 days)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02563301: Videolaryngoscopy in Patients With Cervical Spine Immobilisation
Official title: A Randomised Crossover Trial Comparing the McGrath Series 5 Videolaryngoscope With the Macintosh Laryngoscope in Patients With Cervical Spine Immobilisation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation; Difficult
Lead sponsor: NHS Tayside
Sponsor class: OTHER_GOV
First posted: 2015-09-30
Enrollment: 49
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Tracheal intubation is more difficult in patients in whom cervical spine immobilisation is maintained during tracheal intubation. The McGrath Series 5 videolaryngoscope offers a potential solution. The relatively short radius of the blade curvature combined with the internal arrangement of optimal components means that the glottis can be seen without the need for alignment of the oral, pharyngeal and tracheal axes.

The investigators propose that the McGrath Series 5 videolaryngoscope will improve the view of the larynx in patients with limited neck movements, making intubation quicker, easier and possibly safer.


Eligibility criteria: Inclusion Criteria:

* Elective procedure requiring tracheal intubation
* Over 16 years of age

Exclusion Criteria:

* Emergency procedure
* Less than 16 years of age
* Unable to consent
* Symptomatic gastro-oesophageal reflux disease
* Evidence of raised intracranial pressure
* Known pharyngeal pathology

Primary outcomes:
measure: Cormack and Lehane laryngoscopy grade
timeFrame: 5 minutes
Secondary outcomes:
measure: Time to intubation
timeFrame: 5 minutes
measure: Rate of successful tracheal intubation
timeFrame: 5 minutes
measure: Incidence of complications
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Tayside
country: United Kingdom
facility: NHS Tayside
Study officials:
affiliation: NHS Tayside
name: Lynsey T Foulds, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06399601: A Training Program of Drug Allergy for Healthcare Professionals
Official title: A Training Program of Drug Allergy for Healthcare Professionals: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Drug Allergy
Keywords: Drug allergy
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2024-05-06
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Drug allergy is often under-recognized, yet over- (mistakenly) diagnosed, especially in Hong Kong. There is also a dire shortage of allergy specialists and facilities to tackle the overwhelming drug allergy pandemic. Fortunately, when trained, non-specialist physicians and nurses have demonstrated comparable capabilities in drug allergy evaluation compared to specialists. To potentially promote and propagate the role of non-specialist physicians and nurses toward drug allergy care, the investigators propose a study to investigate the impact of an intensive and focused drug allergy educational course conducted at the University of Hong Kong.

Detailed description: Two identical didactic courses on drug allergy were designed. Each course will last 12 hours and conducted over 2 consecutive days (6 hours each day). All candidates will attend physically and on-site. Various aspects of drug allergy with pre-set learning objectives will be taught in-person by instructors (physicians or nurses specializing in drug allergy nominated by the University of Hong Kong). Course materials and instructors will be identical for each course.

Aims of the study Primary objective

* Investigate the change in knowledge among participants of a 2-day drug allergy educational course
* Investigate the change in clinical practice among participants of a 2-day drug allergy educational course

Secondary objectives

* Investigate the sustained change(s) in knowledge (if any) of participants of a 2-day drug allergy educational course
* Investigate the sustained change(s) in clinical practice (if any) of participants of a 2-day drug allergy educational course

Hypothesis The investigators hypothesize that candidates (practicing physicians and nurses) of the drug allergy course will gain knowledge on drug allergy, which in turn will influence and change their clinical practice.

Eligibility criteria: Inclusion Criteria:

* Registered nurses or doctors actively practicing in Hong Kong
* English speaking;
* Able to complete quizzes and questionnaires;
* Aged 18 or above

Exclusion Criteria:

* People who are unable to communicate in Cantonese or Mandarin
* People who are participating in other drug allergy training course

Primary outcomes:
measure: Change in knowledge of drug allergy as measured by the validated drug allergy questionnaire
timeFrame: After the 2-day training course
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: School of Biomedical Science
Study officials:
References:
Clinical trial NCT04760301: Local Tranexamic Acid During Vaginal Hysteractomy to Reduce Blood Loss
Official title: Local Tranexamic Acid During Vaginal Hysterectomy to Reduce Blood Loss
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Blood Loss
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2021-02-18
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Assessing the efficiency of Prophylactic use of local tranexamic acid during vaginal hysterectomy to reduce blood loss during operation

Detailed description: This randomized control trial will investigate whether local tranexamic acid is efficient for decreasing bleeding during vaginal hysterectomy.

The investigators will randomize local placebo (saline) vs. local 1 gr tranexamic acid; local 1gr tranexamic acid diluted in 10 ml saline and local 10 ml saline at the beginning of surgery.

Eligibility criteria: Inclusion Criteria:

* 20-90 years old female patients going through vaginal hysterctomy

Exclusion Criteria:

* massive bleeding during operation due to major vessles injury
* known coagulopathies
* sensitivity to tranexamic acid
* medical need in tranexamic acid administration during operation due to bleeding

Primary outcomes:
measure: Blood loss during operation - measure in ml
timeFrame: End of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar Saba,
country: Israel
facility: Meir Medical Center
city: Kfar Saba
country: Israel
facility: Meir medical center
Study officials:
References:
Clinical trial NCT03782701: The Effect of Lumify™ Eyedrops on Eyelid Position
Official title: The Effect of Lumify™ (Brimonidine Tartrate Ophthalmic Solution 0.025%) on Palpebral Fissure Height
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Eyelid Droop
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2018-12-20
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The left and right eye of each subject will be randomized to receive either Lumify or balanced saline placebo.
Primary purpose: TREATMENT

Brief summary: The purpose of the research is to see if Lumify™ has an effect on eyelid position.


Eligibility criteria: Inclusion Criteria:

* Adults age 18 and above able to provide informed consent to participate
* Subject with stable ocular health, defined as no ocular conditions requiring ongoing topical therapy or recent surgical intervention

Exclusion Criteria:

* Adults unable to consent
* Prisoners
* Pregnant women.
* Known contradictions or sensitivities to study medication (brimonidine)
* Ocular surgery within the past 3 months or refractive surgery within the past six months
* Grossly abnormal lid margins, anatomical abnormalities, previous eyelid or orbital surgery
* Variable ptosis or eyelid position (e.g., myasthenia gravis, thyroid eye disease, or blepharospasm)
* Significant pre-existing ptosis of any cause (defined as margin reflex distance 1 \< 1mm)
* Any ocular or systemic condition that, in the opinion of the investigator, would confound study data, interfere with the subject's study participation, or affected the subject's safety or trial parameters
* Presence of an active ocular infection
* Prior (within 5 days of beginning study treatment) use of eye whiteners (eg, vasoconstrictors), decongestants, antihistamines (including over the counter and herbal topical ophthalmic medications), phenylephrine dilating drops, any other topical ophthalmic agents
* Inability to sit comfortably for 15 - 30 minutes

Primary outcomes:
measure: Palpebral Fissure Height
timeFrame: Baseline, 5, 15 and 30 minutes after application
Secondary outcomes:
measure: Intraocular Pressure
timeFrame: Baseline, 5, 15 and 30 minutes after application
measure: Eye Redness
timeFrame: Baseline, 5, 15 and 30 minutes after application
measure: Eye Discomfort
timeFrame: Baseline, 5, 15 and 30 minutes after application
Other outcomes:
Locations:
city: Miami
country: United States
facility: Bascom Palmer Eye Institute
state: Florida
Study officials:
affiliation: Bascom Palmer Eye Institute
name: Wendy W Lee, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: