louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04335903: The Turkish Version of the Vividness of Visual Imagery Questionnaire-2
Official title: The Turkish Version of the Vividness of Visual Imagery Questionnaire-2
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Body Image
Assessment, Self
Keywords: Imagination
Motor imagery
Body Image
Kinesthesis
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2020-04-07
Enrollment: 248
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The sample will consist of volunteer, healthy participants.

Brief summary: The Vividness of Visual Imagery Questionnaire-2 (VMIQ-2) is originally developed in English to determine the vividness of visual imagery. The purpose of this study is to translate and cross-culturally adapt the VMIQ instrument into Turkish and investigate its psychometric properties.

Detailed description: The Vividness of Visual Imagery Questionnaire-2 (VMIQ-2) was originally developed in English to determine the vividness of visual imagery. The purpose of this study is to translate and cross-culturally adapt the VMIQ-2 instrument into Turkish and investigate its psychometric properties. One hundred fifty healthy participants will be included. For cross-cultural adaptation, two bi-lingual translators will use the back-translation procedure. Within a 5-to-7-day period after the first assessment, the participants will complete the Turkish version of VMIQ (VMIQ-2-T) to evaluate test-retest reliability. Cronbach's alpha (α) will use to assess internal consistency. The correlation with the Turkish version of Kinesthetic and Visual Imagery Questionnaire-20 will be determined to check the validity.

Eligibility criteria: Inclusion Criteria:

* age over 18 years old
* ability to read and write in Turkish
* no pathology in visual ability and hearing
* able to follow simple instructions

Exclusion Criteria:

* having a chronic disease
* severe musculoskeletal, neurological or cardiovascular disorders that limit mobility
* having any cognitive problem

Primary outcomes:
measure: The Vividness of Visual Imagery Questionnaire-2
timeFrame: Baseline (First assessment)
Secondary outcomes:
measure: The Vividness of Visual Imagery Questionnaire-2
timeFrame: Within a 5-to-7-day period after the first assessment (Second assessment)
measure: The Movement Imagery Questionnaire-3
timeFrame: Baseline (First assessment)
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa
state: Bakırkoy
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Tansu Birinci, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01976403: Intervention Study to Enhance Patients' Pain Management After Cardiac Surgery
Official title: AA Randomized Controlled Trial to Evaluate the Effect of an Intervention to Enhance Patients' Pain Management After Discharge From Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Pain, Postoperative
Other Functional Disturbances Following Cardiac Surgery
Lead sponsor: Oslo Metropolitan University
Sponsor class: OTHER
Collaborators: name: Oslo University Hospital
First posted: 2013-11-05
Enrollment: 416
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The main objective of this randomized controlled trial is to evaluate the effect of an intervention formed as a pain booklet provided to patients at discharge from hospital following cardiac surgery.

The primary objectives are to:

1. Develop and implement a pain booklet to improve pain management after cardiac surgery
2. Evaluate the effect of the pain booklet compared to a group of patients given usual care


Eligibility criteria: Inclusion Criteria:

* undergoing their first elective CABG, valve surgery or a combination
* receiving the standard preadmission information
* able to take care of themselves after discharge
* able to read and write Norwegian and fill in the questionnaires
* able to be contacted by telephone

Exclusion Criteria:

* more than 12 hours at the intensive care unit after surgery

Primary outcomes:
measure: Pain intensity
timeFrame: Baseline, day 1, day 2, day 3, day 4, day 7, day 30, day 90, day 180, day 360
measure: pain-related interference
timeFrame: Baseline, day 7, day 30, day 90, day 180, day 360
Secondary outcomes:
measure: analgesic intake
timeFrame: baseline, day 1, day 2, day 3, day 4, day 7, day 30, day 90, day 180, day 360
measure: Quality of life
timeFrame: baseline, day 7, day 90, day 180, day 360
Other outcomes:
measure: Barriers to pain management
timeFrame: baseline
measure: pain sensitivity
timeFrame: baseline
measure: Hope
timeFrame: day 90, day 180, day 360
measure: Social support
timeFrame: day 90, day 180, day 360
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo Metropolitan University
name: Marit Leegaard, PhD RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bjornnes AK, Parry M, Lie I, Falk R, Leegaard M, Rustoen T. The association between hope, marital status, depression and persistent pain in men and women following cardiac surgery. BMC Womens Health. 2018 Jan 2;18(1):2. doi: 10.1186/s12905-017-0501-0.
Clinical trial NCT01110603: A Study of MK-4827 in Combination With Standard Chemotherapy in Participants With Advanced Solid Tumors (MK-4827-008 AM1)
Official title: A Phase Ib Dose Escalation Study of MK-4827 in Combination With Carboplatin, Carboplatin/Paclitaxel and Carboplatin/Liposomal Doxorubicin in Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Cancer: Solid Tumors
Keywords: Cancer
Advanced Solid Tumors
Lead sponsor: Tesaro, Inc.
Sponsor class: INDUSTRY
First posted: 2010-04-26
Enrollment: 12
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 find the dose limiting toxicities (DLTs), maximum tolerated dose (MTD), and recommended Phase 2 dose (RPTD) of MK4827 when administered in combination with standard doses of carboplatin, or carboplatin/paclitaxel, or carboplatin/liposomal doxorubicin in the treatment of advanced solid cancers in adults.

Detailed description: The decision to discontinue new enrollment is not related to any concerns about the safety profile of the product.

Eligibility criteria: Inclusion Criteria:

* Participant has a locally advanced or metastatic solid tumor for which carboplatin, carboplatin/paclitaxel, or carboplatin/liposomal doxorubicin are the standard of care.
* Participant has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.

Exclusion Criteria:

* Participant has had chemotherapy, radiotherapy, or biological therapy within 4 weeks prior to entering the study.
* Participant has had more than two prior lines of chemotherapy.
* Participant has known central nervous system metastases or a primary central nervous system tumor.
* Participant is pregnant or breastfeeding or expecting to conceive during the timeframe of the study.
* Participant is known to be human immunodeficiency virus (HIV) positive.
* Participant has a history of Hepatitis B or C.
* Participant has a symptomatic pleural effusion.
* Participant with a left ventricular ejection fraction (LVEF) below the institutional norm, or with prior exposure to doxorubicin is not eligible for the MK4827 + carboplatin/liposomal doxorubicin study arm.

Primary outcomes:
measure: Number of participants with dose limiting toxicities (DLTs)
timeFrame: Each cycle (21 or 28 Days)
Secondary outcomes:
measure: Number of participants with clinical and laboratory adverse events (AEs)
timeFrame: Baseline to 30 days post last dose
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03193203: Pharmacokinetics, Safety, and Tolerability Study of the Autoinjector and Pre-filled Syringe of SB4 in Healthy Male Subjects
Official title: A Randomised, Open-label, Two-period, Two-sequence, Single-dose, Cross-over Study to Compare the Pharmacokinetics, Safety, and Tolerability of the Autoinjector and Pre-filled Syringe of SB4 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Samsung Bioepis Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-06-20
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this study is to compare the pharmacokinetics, safety, and tolerability of the autoinjector and pre-filled syringe of SB4 in healthy male subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects aged 18-55 years
* Have a body weight between 60.0 - 85.5 kg (inclusive) and a body mass index between 20.0 - 28.0 kg/m2 (inclusive)

Exclusion Criteria:

* Have a history and/or current presence of clinical significant atopic allergy, hypersensitivity or allergic reactions, also including known or suspected clinically relevant drug hypersensitivity to etanercept or to any of the excipient
* Have either active or latent TB or who have a history of TB
* Have clinically significant active infection within 4 weeks before the first IP administration
* Have had a history of serious infection
* Have previously been exposed to etanercept, if known
* Have previously been exposed to a biological agent or immunosuppressive agent within 120 days prior to the first IP administration
* Have a history of invasive systemic fungal infections or other opportunistic infections judged as relevant by the Investigator

Primary outcomes:
measure: AUCinf ACUinf
timeFrame: 56 days
measure: AUClast
timeFrame: 56 days
measure: Cmax
timeFrame: 56 days
Secondary outcomes:
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: PRA Health Sciences
Study officials:
References:
Clinical trial NCT06857903: Using Nudges to Recruit for Health-Related Research
Official title: Using Nudges to Recruit Human Subjects in Clinical & Translational Research
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Participation
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2025-03-05
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The goal of this clinical trial is to examine the effect of using behavioral nudges in recruitment into a minimal risk interview study among healthy adult volunteers.

Individuals will be randomized to receive recruitment materials that do or do not contain a set of behavioral nudges. Researchers will compare the effect on participation in an interview study (primary outcome) between these conditions.


Eligibility criteria: Inclusion Criteria:

English-speaking; 18 years of age or older

Exclusion Criteria:

None

Primary outcomes:
measure: Agreement to participate in an interview study
timeFrame: Within one month after initial outreach
Secondary outcomes:
measure: Engagement with outreach materials
timeFrame: Within one month after initial outreach
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: Kimberly Kaphingst, ScD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01949103: TD-1607 MAD Study in Healthy Subjects
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose (MAD) Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TD-1607, a Glycopeptide-Cephalosporin Heterodimer Antibiotic, in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Infections
Bacterial Infections
Keywords: Gram-positive
Lead sponsor: Theravance Biopharma
Sponsor class: INDUSTRY
First posted: 2013-09-24
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: TD-1607, administered intravenously as multiple ascending doses, will be investigated in healthy subjects to assess its tolerability, safety, and pharmacokinetics.


Eligibility criteria: Inclusion Criteria:

* Subject is a healthy nonsmoking male or a female (of non-childbearing potential) and 18 to 55 years old, inclusive, at Screening.
* Subject has a body mass index (BMI) of 19 to 30 kg/m2, inclusive, and weighs at least 50 kg.

Subject has no clinically significant abnormalities in the results of laboratory evaluations at Screening and Day -1.

Exclusion Criteria:

* Subject has evidence or history of clinically significant, relevant hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (except for untreated, asymptomatic seasonal allergies at time of dosing).
* Subject has a history of allergies or hypersensitivities to glycopeptide (e.g., vancomycin) or beta-lactam (e.g., penicillin or cephalosporin) antibiotics.
* Subject has participated in another clinical trial of an investigational drug (or medical device) within 60 days (or 5 half-lives, whichever is longer) prior to Screening or is currently participating in another trial of an investigational drug (or medical device).
* Subject has previously participated in a trial for TD-1607.

Primary outcomes:
measure: Number of adverse events
timeFrame: 17 days
Secondary outcomes:
measure: Cmax
timeFrame: 17 Days
measure: Tmax
timeFrame: 17 Days
measure: AUC0-t
timeFrame: 17 Days
measure: AUC0-24
timeFrame: 17 Days
measure: AUCinf
timeFrame: 17 Days
measure: CL
timeFrame: 17 Days
measure: Vdss
timeFrame: 17 Days
measure: t1/2
timeFrame: 17 Days
measure: Amount excreted in urine (Ae
timeFrame: 17 Days
measure: Fraction eliminated in urine (fe)
timeFrame: 17 Days
measure: CLr
timeFrame: 17 Days
measure: Ctrough
timeFrame: 17 Days
Other outcomes:
Locations:
city: Austin
country: United States
facility: PPD, Phase 1 Clinic
state: Texas
Study officials:
affiliation: Theravance Biopharma
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04538703: Social Media Use of Acne Vulgaris Patients: Multicenter, Survey Work
Official title: Social Media Use of Acne Vulgaris Patients: Multicenter, Survey Work
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acne Vulgaris
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2020-09-04
Enrollment: 3000
Sex: ALL
Minimum age (years): 12
Maximum age (years): 60
Standard ages: CHILD
ADULT
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: acne vulgaris patients between 12-60 years of age

Brief summary: Acne Vulgaris is a chronic skin disease. However, chronic and repetitive due to the quality of life and psychological status of patients can affect. For this reason, patients carry out various research on their diseases on social media and follow programs on these issues in other media such as television and radio. However, there is no study on how much patients are interested in these publications, how much they trust them, and how they reach and organize information via social media. The aim of the study will be to clarify how and how patients with Acne Vulgaris use social media to obtain information about the diagnosis and treatment of their disease, the interaction of patient groups with each other, and how often social media is used, especially in which group of patients.


Eligibility criteria: Inclusion Criteria:

* acne vulgaris patient

Exclusion Criteria:

* who does not want to answer the questions

Primary outcomes:
measure: Social media use of acne vulgaris patients, a questionnaire will be asked the patients and try to learn how they use social media for getting information about their disease.
timeFrame: september 2020
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Melek Aslan Kayıran
Study officials:
References:
Clinical trial NCT00112203: Long-Term Safety and Efficacy of Itopride Hydrochloride (HCl) in Patients Suffering From Functional Dyspepsia
Official title: A Multicentre, Open-Label Extension Phase to Study the Long-Term Safety and Efficacy of Itopride HCl in Patients Suffering From Functional Dyspepsia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dyspepsia
Keywords: Abdominal Symptom Relief
Fullness
Bloating
Indigestion
Functional dyspepsia
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2005-06-01
Enrollment: 466
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Itopride is a compound already marketed in Japan and in some countries of Eastern Europe under the name of Ganaton. It is used to treat symptoms of functional dyspepsia. Patients suffering from this condition have difficulties digesting food. Patients feel full after eating; they have bloating and have stomach pain. The goal of this study is to see if itopride helps to relieve the symptoms of functional dyspepsia on a long-term basis.

Detailed description: All patients who have completed study ITOFD04-03 will be offered to continue to be treated with itopride for a period of up to one year in duration. A target of 300 patients will be followed up for 6 months. Of these, a target of 100 patients will be kept on treatment for an additional 6 months.

Patients will need to come to the clinic for evaluations every 8 weeks during the trial. Evaluations done at these visits will include: lab tests, evaluation of the heartburn condition, and a questionnaire needed to be completed by the patient to see if the drug is helpful in relieving their symptoms.

Eligibility criteria: Inclusion Criteria:

* Patients must have completed the 8 week double-blind study ITOFD04-03
* Female patients must not be pregnant (must have a negative serum pregnancy test)

Exclusion Criteria:

* Patients with any newly occurring medical condition which was an exclusion criterion at ITOFD04-03 study entry

Primary outcomes:
measure: Long-term safety
timeFrame: every 2 months
Secondary outcomes:
measure: Long-term relief of symptoms
timeFrame: every 2 months
Other outcomes:
Locations:
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Jan Tack, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Leuven
name: Jan Tack, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00549003: Efficacy and Cost Effectiveness of Malaria Diagnosis Procedures and the Rational Use of ACT in Zanzibar
Official title: Efficacy and Cost Effectiveness of Malaria Diagnosis Procedures and the Rational Use of ACT in Zanzibar
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Malaria
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
First posted: 2007-10-25
Enrollment: 9346
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to assess performance and cost-effectiveness of rapid diagnostic test(RDT) aided malaria diagnosis versus symptom-based/clinical diagnosis in patients of all ages with reported fever last 48 hours alone in primary health care settings in Zanzibar.


Eligibility criteria: Inclusion Criteria:

* Any patient attending the study sites and reporting history of fever within past 48 hours or other symptoms compatible with malaria and giving their informed consent, will be eligible for the study.

Exclusion Criteria:

* Patient's refusal to consent will disqualify participation in the study.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Zanzibar
country: Tanzania
facility: Muyuni, Uzini, Kinyasini and Mzambarauni Primary Health Care Units
Study officials:
affiliation: Karolinska UH
name: Anders Björkman, MD,PhD
role: STUDY_DIRECTOR
affiliation: Karolinska UH
name: Mwinyi I Msellem, HLSO
role: PRINCIPAL_INVESTIGATOR
References:
citation: Msellem MI, Martensson A, Rotllant G, Bhattarai A, Stromberg J, Kahigwa E, Garcia M, Petzold M, Olumese P, Ali A, Bjorkman A. Influence of rapid malaria diagnostic tests on treatment and health outcome in fever patients, Zanzibar: a crossover validation study. PLoS Med. 2009 Apr 28;6(4):e1000070. doi: 10.1371/journal.pmed.1000070. Epub 2009 Apr 28.
Clinical trial NCT06353503: Bone Marrow Aspirate Concentrate for Anterior Cruciate Ligament Tear Treatment.
Official title: Using Autologous Bone Marrow Aspirate Concentrate to Treat Complete Anterior Cruciate Ligament Tear.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anterior Cruciate Ligament Tear
Lead sponsor: Global Stem Cell Center, Baghdad
Sponsor class: INDUSTRY
First posted: 2024-04-09
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: single armed study open label
Primary purpose: TREATMENT

Brief summary: A single armed multicenter study enrolling 20 patients using autologous bone marrow aspirate concentrate (which is done under local or general anesthesia to aspirate around 1-2 cc/kg body weight then concentration which is done by using centrifugation and special disposable kit) local injection of 4 cc per joint under ultrasonic guidance ,completely sterile field with local anesthesia.

Detailed description: The anterior cruciate ligament (ACL) is key to the functional stability of the knee joint and is highly susceptible to injury, especially in athletes engaged in high-impact sports. Conventional treatment for partial tears may involve conservative management; however, complete tears often necessitate surgical reconstruction. In seeking alternative treatments, this study investigates the potential of bone marrow aspirate concentrate BMAC-a regenerative medicine approach-to promote healing and restore functionality to completely torn ACLs. The regenerative properties of BMAC, attributed to the presence of stem cells and growth factors, may facilitate ligament repair and regeneration. the team aim treating 1st and 2nd degree anterior cruciate ligament tear without retraction.

Eligibility criteria: Inclusion Criteria:

1- Confirmed diagnosis of complete or partial ACL tear via clinical examination and imaging studies.

2. Aged between 20 and 55 years, to encompass the typical age range of patients with sports-related ACL injuries.

Exclusion Criteria:

1- Patients with a history of bleeding disorders, as this could complicate the aspiration and injection procedures.

2. Individuals with a history of malignancy, due to the potential risks associated with growth factors present in BMAC.

3. Critically ill patients or those with comorbidities

Primary outcomes:
measure: Functional recovery by clinical assessments of the ACL and overall knee joint stability.
timeFrame: every 12 weeks till 6 months
Secondary outcomes:
measure: magnetic resonance imaging of the knee joint
timeFrame: 6 months from starting recruitment
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: Ministry of Health
Study officials:
affiliation: clinical stem cell studies
name: abdulmajeed a hammadi, MD
role: STUDY_DIRECTOR
References: