louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02094521: Evaluation of Optimal Dosing Conditions for GLP-1 Analogue NNC0113-0987 When Administered Orally in Healthy Male Subjects
Official title: Evaluation of Optimal Dosing Conditions for GLP-1 Analogue NNC0113-0987 When Administered Orally in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2014-03-24
Enrollment: 122
Sex: MALE
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: This trial is conducted in Europe. The aim of the trial is to evaluate the optimal dosing conditions for GLP-1 analogue NNC0113-0987 when administered orally in healthy male subjects.


Eligibility criteria: Inclusion Criteria:

* Male aged 18 between 55 years (both inclusive) at the time of signing informed consent
* Good general health based on medical history, physical examination, and results of vital signs, electrocardiogram and laboratory safety tests performed during the screening visit, as judged by the investigator
* Body mass index (BMI) between 18.5 and 29.9 kg/m\^2 (both inclusive)

Exclusion Criteria:

* History of, or presence of, cancer, diabetes or any clinically significant cardiovascular,respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders, as judged by the investigator
* Blood pressure above 140 mmHg systolic and/or above 90 mmHg diastolic or pulse above 90 beats per minute at the screening visit
* Smoking more than 5 cigarettes or the equivalent per day (including use of nicotine substitute products)
* History of significant drug abuse, or a positive drug test at the screening visit
* Any blood draw in excess of 25 mL in the past month, or donation of blood or plasma in excess of 400 mL within the 3 months preceding the screening visit

Primary outcomes:
measure: Area under the NNC0113-0987 plasma concentration time curve
timeFrame: From time 0 to 24 hours after the 10th dosing
Secondary outcomes:
measure: Maximum observed NNC0113-0987 plasma concentration
timeFrame: 0 to 24 hours after the 10th dosing
Other outcomes:
Locations:
city: Harrow
country: United Kingdom
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT04477421: Femtosecond Small Incision Lenticular Extraction in Comparison to Femtosecond Laser Insitu Keratomileusis Regarding Dry Eye Disease
Official title: Femtosecond Small Incision Lenticular Extraction in Comparison to Femtosecond Laser Insitu Keratomileusis Regarding Dry Eye Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye Disease
Lead sponsor: Al-Rasheed University College
Sponsor class: OTHER
First posted: 2020-07-20
Enrollment: 100
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: Comparison of femtosecond small incision lenticule extraction (FS-SMILE) versus Femtosecond laser Insitu Keratomileusis (FS-LASIK) regarding dry eye disease (DED) and corneal sensitivity (CS) after those refractive surgeries.


Eligibility criteria: Inclusion Criteria:

* bilateral eyes with spherical correction range from -2 to -6 diopters and cylinder range from 0 to - 3.5 diopters

Exclusion Criteria:

* sign or symptom of dry eye disease (tear film breakup time (TBUT) \>10 seconds
* Schirmer I test \>10 mm /5 minutes)
* corneal or conjunctival staining
* Meibomian gland dysfunction
* Previous ocular and or eyelid medical or surgical treatment
* pregnancy
* Chronic systemic disorder

Primary outcomes:
measure: Ocular Surface Disease Index
timeFrame: After 1 month of surgery
measure: Ocular Surface Disease Index
timeFrame: After 6 months of surgery
measure: Tear Break-Up Time
timeFrame: After 1 month of surgery
measure: Tear Break-Up Time
timeFrame: After 6 months of surgery
measure: Schirmer I test
timeFrame: After 1 month of surgery
measure: Schirmer I test
timeFrame: After 6 months of surgery
measure: Oxford score
timeFrame: After 1 month of surgery
measure: Oxford score
timeFrame: After 6 months of surgery
measure: Dry Eye Work Shop scale
timeFrame: After 1 month of surgery
measure: Dry Eye Work Shop scale
timeFrame: After 6 months of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: Al-Rasheed University College
state: AL-Adhmia
Study officials:
References:
Clinical trial NCT00856921: Genetic Evaluation of AAAS Gene in Early-Onset Achalasia and Alacrima Patients
Official title: To Find Out the Genetic Relationship Between the Early-Onset Achalasia and AAAS Gene
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Achalasia
Alacrima
Keywords: Relationship between achalasia and AAAS gene
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2009-03-06
Enrollment: 19
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Early age onset achalasia

Brief summary: The AAAS gene has been known to cause achalasia, alacrima, adrenal abnormalities and a progressive neurological syndrome. A considerable proportion of achalasia patients have been known to show alacrima (decreased secretion of tears). However, the genetic mechanism between achalasia and alacrima has not been defined yet. The investigators postulated that some proportions of early-onset achalasia could be correlated with AAAS gene; thus, the investigators aimed to investigate the relationship between the AAAS gene and early-onset achalasia.


Eligibility criteria: Inclusion Criteria:

* early age onset
* primary achalasia patient
* less than 35 years old

Exclusion Criteria:

* secondary achalasia patients

Primary outcomes:
measure: Genetic relationship between achalasia and AAAS gene
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06991621: The Effect of Situation Puzzle Games on Nursing Students' Death Anxiety and Meaning in Life
Official title: Mechanisms and Design Framework Study of Gamified Education in Professional Identity Formation for Medical Undergraduates
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Death Anxiety
Lead sponsor: China Medical University, China
Sponsor class: OTHER
First posted: 2025-05-28
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Goal of this interventional study

The purpose of this research is to investigate the effects of a scenario-based puzzle educational game on death anxiety and meaning in life among nursing students. It aims to answer the following key questions:

Can the scenario-based puzzle educational game enhance nursing students' sense of meaning in life?

Can the scenario-based puzzle educational game reduce death anxiety in nursing students?

What are nursing students' experiences and perceptions of this educational game?

Study design Researchers will compare the intervention group (participating in the game) with a control group (receiving death education manuals) to evaluate the effectiveness of the game-based intervention.

Participants will:

Be recruited through campus posters

Be randomly assigned to either the intervention or control group and complete baseline questionnaires

In the control group: Receive death education manuals twice weekly for 3 weeks

In the intervention group: Participate in group sessions (5 students per group) to play the scenario-based puzzle game twice weekly for 3 weeks

Complete follow-up questionnaires and participate in qualitative interviews regarding their experiences with manual-based education or the game intervention after the 3-week intervention period


Eligibility criteria: Inclusion Criteria:

* Third-year full-time undergraduate nursing students
* Completed clinical observation training but not yet entered clinical internship phase
* Aged ≥18 years
* Provide informed consent and voluntarily participate in the study

Exclusion Criteria:

* Participated in similar death education interventions within the past 3 months
* Diagnosed with severe mental or psychological disorders
* Currently on a leave of absence (academic or personal)

Primary outcomes:
measure: Death Anxiety
timeFrame: Week 0, Week 3
measure: Meaning in Life
timeFrame: Week 0, Week 3
Secondary outcomes:
Other outcomes:
Locations:
city: Shenyang
country: China
facility: School of Nursing, China Medical University
state: Liaoning
Study officials:
References:
Clinical trial NCT02740621: The Impact of Opioids in Coronary Heart Disease
Official title: Evaluation of Past Medications in Patients With Coronary Heart Disease and Patients Hospitalized for a Non-cardiac Reason
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Heart Disease
Lead sponsor: Ruhr University of Bochum
Sponsor class: OTHER
Collaborators: name: Mundipharma Research GmbH & Co KG
First posted: 2016-04-15
Enrollment: 750
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: hospitalized patients in University Hospital

Brief summary: In this study, the risk of opioid medications on coronary heart disease in adults is investigated. Patients with the necessity of a coronary angiography and control patients with a non-cardiac disease of the same hospital are inquired with a standardized questionnaire about demographic and clinical risk factors for heart attack. An impact of opioid medications on coronary heart disease is hypothesised (MIOP).

In addition, all patients with coronary angiography should be consulted twice (after 3 and 6 months) to find out how many of these patients have developed a refractory angina pectoris (TRAPS).


Eligibility criteria: Inclusion Criteria:

* 40 years or older
* written informed consent

Exclusion Criteria:

* currently cancer
* cognitive limitations

Primary outcomes:
measure: Number of patients with opioid treatment (WHO II/ WHO III) within the last 10 years before present hospitalization, Interview with standardized CRF
timeFrame: 20 minutes
measure: Number of patients with refractory angina pectoris, Interview with standardized CRF
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Bochum
country: Germany
facility: Bergmannsheil department of pain therapy
state: Nordrhein-Westfalen
Study officials:
References:
Clinical trial NCT02393521: The Effect of Vibration Therapy Over Neck Myofascial Trigger Points
Official title: The Effect of Vibration Therapy on Pressure Pain Thresholds Over Neck Myofascial Trigger Points: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myofascial Trigger Point Pain
Neck Pain
Keywords: Vibration
Pressure Pain Threshold
Trigger Points
Neck Pain
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2015-03-19
Enrollment: 13
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 was to investigate the efficacy of a self-administered vibration therapy treatment on neck pain, disability and pressure pain thresholds in patients with non-specific neck pain and myofascial trigger points (MTrPs). The investigators hypothesized that patients receiving vibration therapy would report less perceived neck pain, disability and present higher PPTs after receiving vibration therapy when compared to a control no-treatment group.

Detailed description: Myofascial trigger points (MTrPs) are a common source of (regional) pain in patients presenting with musculoskeletal pain. Mechanical vibration has been suggested as a treatment for pain relief. In this study, the effects of vibration therapy on people with non-specific neck pain and MTrPs were investigated. Seventeen chronic non-specific neck pain patients were randomly assigned to a treatment (vibration group, n = 9) or control group (n = 8). Vibration group received 10 self-administered sessions of vibration therapy (45-50 Hz for 15 minutes with the subject laying in supine). Perceived neck pain and disability and pressure pain thresholds over MTrPs of the upper trapezius and levator scapulae bilateraly were measured at baseline and after the first, five and 10 treatment sessions.

Eligibility criteria: Inclusion Criteria:

* a score of ≥ 5/50 in Neck Disability Index
* active or latent myofascial trigger points in upper trapezius or levator scapulae muscles

Exclusion Criteria:

* previous cervical spine surgery
* cervical radiculopathy
* severe systemic disease
* fibromyalgia
* other widespread musculoskeletal pain syndromes
* patients being treated with medication or physiotherapy within the last 4 weeks

Primary outcomes:
measure: Pressure Pain Threshold (PPT)
timeFrame: 10 days
Secondary outcomes:
measure: Neck Disability Index (NDI)
timeFrame: 10 days
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Universitat de Valencia
Study officials:
affiliation: University of Valencia
name: Sofía Pérez, PhD
role: STUDY_DIRECTOR
References:
citation: Imtiyaz S, Veqar Z, Shareef MY. To Compare the Effect of Vibration Therapy and Massage in Prevention of Delayed Onset Muscle Soreness (DOMS). J Clin Diagn Res. 2014 Jan;8(1):133-6. doi: 10.7860/JCDR/2014/7294.3971. Epub 2014 Jan 12.
Clinical trial NCT04954521: Anlotinib for Hepatocellular Carcinoma
Official title: A Real World Study on the Effect of Single or Combined Treatment of Anlotinib on Survival and Prognosis of Advanced Hepatocellular Carcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Neoplasms
Lead sponsor: People's Hospital of Guangxi Zhuang Autonomous Region
Sponsor class: OTHER
First posted: 2021-07-08
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with advanced liver cancer

Brief summary: The purpose of this study is to observe and explore the effect of single or combined treatment of arotinib on the survival and prognosis of patients with advanced liver cancer in the real world, and to summarize the treatment experience of a wide range of people.


Eligibility criteria: Inclusion Criteria:

1. Age: ≥ 18 years old, male or female;
2. Patients with advanced liver cancer were diagnosed;
3. Patients assessed by doctors to benefit from single or combined treatment of arotinib;
4. Patients volunteered to join the project.

Exclusion Criteria:

None

Primary outcomes:
measure: OS
timeFrame: From date of admission until the date of death from any cause, assessed up to 24 months
Secondary outcomes:
measure: PFS
timeFrame: From date of admission until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Other outcomes:
Locations:
city: Nanning
country: China
facility: People's Hospital of Guangxi Zhuang Autonomous Region
state: Guangxi
Study officials:
References:
Clinical trial NCT01514721: Efficacy of Changing to DuoTrav® (Travoprost 0.004%/Timolol 0.5% BAK-Free Fixed Combination) From Prior Therapy
Official title: Assessing the Efficacy and Tolerability of Changing to DuoTrav® (Travoprost 0.004%/Timolol 0.5% BAK-Free Fixed Combination), as Replacement Therapy in Patients Previously on Prior Prostaglandin Fixed Combination
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Glaucoma
Keywords: Open-angle glaucoma
Ocular hypertension
Pigment dispersion glaucoma
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2012-01-23
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess efficacy and tolerability of changing to DuoTrav® (Travoprost 0.004%/Timolol 0.5% BAK-free) from prior Xalacom® or Ganfort® fixed combination pharmacotherapy in patients with open-angle glaucoma or ocular hypertension with uncontrolled intraocular pressure (IOP).


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of ocular hypertension, open-angle glaucoma, or pigment dispersion glaucoma in both eyes.
* On a stable IOP-lowering regimen of prostaglandin fixed combination (either Xalacom or Ganfort) within 4 weeks prior to the Screening Visit.
* IOP between 19 and 35 mmHg at any time of day in at least 1 eye.
* Best corrected visual acuity (BCVA) of 6/60 (20/200 Snellen; 1.0 LogMAR) or better in each eye.
* Willing to discontinue the use of all other ocular hypotensive medication(s) prior to receiving the study medication for the entire course of the study.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Known medical history of allergy, hypersensitivity, or poor tolerance to any component of DuoTrav® deemed clinically significant in the opinion of the Principal Investigator.
* Corneal dystrophies in either eye.
* Risk of visual field or VA worsening as a consequence of participation in the study, in the investigator's best judgment.
* Any disease or condition that would preclude the safe administration of a topical beta-blocker, present a special risk to the subject, or interfere with optimal participation in the study.
* Women who are pregnant or lactating.
* Participation in any other investigational study within 30 days prior to the Screening Visit.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Change in intra-ocular pressure (IOP) at final visit from prior therapy (i.e., from baseline)
timeFrame: 12 weeks
Secondary outcomes:
measure: Percentage of patients who reach target IOP (≤18mmHg)
timeFrame: 12 weeks
measure: Change in Ocular Surface Disease Index (OSDI) score at final visit from baseline
timeFrame: 12 weeks
measure: Change in ocular hyperemia score at final visit from baseline
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Alcon Investigational Site
Study officials:
affiliation: Alcon Research
name: Abayomi Ogundele, PharmD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03605121: Waist Circumference in Cardiac Surgery
Official title: Association Between Waist Circumference or BMI and Clinical Outcome in Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity, Abdominal
Keywords: waist circumference
body mass index
cardiac surgery
mortality
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2018-07-30
Enrollment: 5000
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients undergoing cardiac surgery between 2004 and 2017 at Seoul National University Hospital

Brief summary: Metabolic syndrome including increased body mass index or waist circumference is known to be a risk factor of cardiovascular disease. However, the relationship between body mass index or waist circumference and clinical outcome after cardiac surgery has not been fully elucidated.

Detailed description: Along with body mass index, which is determined with height and weight, waist circumference reflects abdominal obesity and may increase cardio-metabolic risk and all-cause morbidity/mortality. In this observational study, we will review the electronic medical records of patients underwent cardiac surgery and assess their waist circumference, measured on preoperative computed tomography, as well as body mass index. The relationship between body mass index or waist circumference and mortality after cardiac surgery will be analysed.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing cardiac surgery between 2004 and 2016 at Seoul National University Hospital

Exclusion Criteria:

* Patients without information on height, weight, or waist circumference from abdominal computed tomography

Primary outcomes:
measure: mortality
timeFrame: through study completion, average 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Youn Joung Cho, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03269279: Mifepristone and Misoprostol for 2nd Trimester Termination of Pregnancy in Burkina Faso
Official title: Mifepristone and Misoprostol for 2nd Trimester Termination of Pregnancy (13-22 Weeks LMP) in Burkina Faso
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Medical; Abortion, Fetus
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
First posted: 2017-08-31
Enrollment: 100
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this study is to examine the effectiveness and feasibility of a mifepristone-misoprostol medical abortion regimen in terminating pregnancies 13-22 weeks in Burkina Faso.


Eligibility criteria: Inclusion Criteria:

* Having an ongoing pregnancy of 13-22 weeks gestation
* Be willing to undergo surgical completion if necessary
* Have no contraindications to study procedures, according to provider
* Be willing and able to consent to participate in the study
* Be willing to follow study procedures
* Respect legal indications for obtaining an abortion

Exclusion Criteria:

* Known allergy to mifepristone or misoprostol/prostaglandin
* Any contraindications to vaginal delivery, including placenta previa
* Previous transmural uterine incsion

Primary outcomes:
measure: Rate of successful abortion
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Bobo-Dioulasso
country: Burkina Faso
facility: CHUSS
city: Boromo
country: Burkina Faso
facility: CMA Boromo
city: Ouagadougou
country: Burkina Faso
facility: CHUYO
city: Ouahigouya
country: Burkina Faso
facility: CHR Ouahigouya
Study officials:
affiliation: SOGOB
name: Blandine Thieba, MD
role: STUDY_DIRECTOR
affiliation: SOGOB
name: Evelyne Komboigo, MD
role: STUDY_CHAIR
References: