louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06494761: A Study in Healthy Men to Test Whether Zongertinib Affects How 3 Other Medicines (Midazolam, Omeprazole, and Repaglinide) Are Taken up and Processed by the Body
Official title: The Effect of Multiple Doses of Zongertinib on the Single-dose Pharmacokinetics of Midazolam, Omeprazole and Repaglinide in Healthy Male Subjects (an Open-label, 2-period, Fixed-sequence Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2024-07-10
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main objective of this trial is to assess the effect of multiple oral doses of zongertinib on the pharmacokinetics of midazolam, omeprazole and repaglinide.


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
* Age of 18 to 55 years (inclusive)
* Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
* Signed and dated written informed consent

Exclusion Criteria:

* Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetre(s) of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 beats per minute (bpm)
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease assessed as clinically relevant by the investigator Further exclusion criteria apply.

Primary outcomes:
measure: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
timeFrame: Up to 15 days
measure: Maximum measured concentration of the analyte in plasma (Cmax)
timeFrame: Up to 15 days
Secondary outcomes:
measure: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
timeFrame: Up to 15 days
Other outcomes:
Locations:
city: Biberach
country: Germany
facility: Humanpharmakologisches Zentrum Biberach
Study officials:
References:
Clinical trial NCT01914861: Cortisol Diurnal Variation and the Risk for Developing Post Traumatic Stress Disorder
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Posttraumatic Stress Disorders
Cortisol Diurnal Variation
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2013-08-02
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men/Women, age 21-65, who have arrived at the Chaim Sheba Medical Center ER within six hours of exposure to a traumatic event.

Brief summary: The purpose of this study is to examine a possible link between the time of day of exposure to a traumatic event and the risk of developing post-traumatic stress disorder. Clinical and biological correlates will also be examined from this perspective.


Eligibility criteria: Inclusion Criteria:

1. Persons 21-65 years old, who have been exposed to an event meeting the following DSM-IV criterion for Acute Stress Disorder:

   Criteria A.1 and A.2 At least one of Criteria B1-5A.1
2. Who provide written, informed consent to participate in the study.

Exclusion Criteria:

1. Physical injury that would contraindicate participation or interfere with a subject's ability to give informed consent or cooperate with the screening or collection of initial measures. Examples include severe burn injury, life-threatening medical or surgical condition, condition requiring surgical intervention under general anesthesia, as indicated by Abbreviated Injury Scale (AIS), or by clinical judgment;
2. Head injury involving confusion, loss of consciousness, or amnesia;
3. Medical conditions such as extreme obesity, psoriasis, herpes, Cushing's syndrome, current infectious disease, current viral disease, tuberculosis, unstable diabetes or hypertension, myasthenia gravis, and heart failure. Persons taking medications that can interfere with the HPA axis (e.g.,steroids, betablockers,indomethacin) will be excluded;
4. Weight below 45 or above 120 kg.
5. Pregnancy (in suggestive cases, a pregnancy test will be performed);
6. Traumatic exposure that reflects ongoing victimization (e.g., domestic violence) to which the subject is likely to be re-exposed during the study period.
7. Overt psychopathology, intoxication, or under the influence of substances.
8. Evidence or history of schizophrenia, bipolar, other psychotic condition;
9. Prior history of PTSD;
10. Current or past history of dementia, amnesia, or other cognitive disorder predating trauma exposure;
11. Assessed serious suicide risk. -

Primary outcomes:
measure: Development of Posttraumatic stress disorder
timeFrame: six months
Secondary outcomes:
measure: Biological correlates of post-traumatic stress disorder
timeFrame: six months
measure: correlation between development of Posttraumatice stress disorder and time of traumatic event
timeFrame: six months
Other outcomes:
Locations:
city: Ramat-Gan
country: Israel
facility: Chaim Sheba Medical Center
Study officials:
References:
Clinical trial NCT00844961: Effectiveness of Internet Delivered Cognitive Behavior Therapy (CBT) for Irritable Bowel Syndrome (IBS)
Official title: Study of the Effectiveness of Internet Delivered Cognitive Behavior Therapy in a Sample of Consecutively Recruited Patients Diagnosed With Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Keywords: IBS
CBT
Internet treatment
Cognitive behavior therapy
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Allmänna arvsfonden
name: Region Stockholm
name: Königska-Söderströmska sjukhemmet
name: Aleris Helse
First posted: 2009-02-16
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will recruit 80 out-patients diagnosed with Irritable Bowel Syndrome from a gastroenterological clinic. The recruitment will be consecutive with all patients receiving the diagnosis being offered to participate. After recruitment and 3 week baseline measure of IBS symptoms they will be randomised to either 10 weeks of internet delivered CBT or waiting list. After treatment IBS-symptoms are measured again to assess treatment effectiveness. All patients on waiting list are offered the same treatment as patients randomised to treatment.

All patients are assessed 12 months after completion of treatment.

Patients in treatment condition are hypothesized to experience significant reduction IBS symptoms and quality of life compared to patients on waiting list.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Irritable Bowel Syndrome according to Rome III criteria

Exclusion Criteria:

* History of inflammatory bowel disease (IBD)
* Symptom debut after age of 50
* Ongoing severe mental illness (psychosis, severe depression, suicidal ideation, bipolar disease)
* Inability to participate in internet delivered treatment

Primary outcomes:
measure: The Gastrointestinal Symptom Rating Scale - IBS Version (GSRS-IBS)
timeFrame: Before treatment
measure: The Gastrointestinal Symptom Rating Scale - IBS Version (GSRS-IBS)
timeFrame: After treatment
measure: The Gastrointestinal Symptom Rating Scale - IBS Version (GSRS-IBS)
timeFrame: 12 months after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Internetpsykatrienheten, M57, Psykiatri sydväst
Study officials:
affiliation: Karolinska Institutet
name: Nils Lindefors, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ljotsson B, Andersson G, Andersson E, Hedman E, Lindfors P, Andreewitch S, Ruck C, Lindefors N. Acceptability, effectiveness, and cost-effectiveness of internet-based exposure treatment for irritable bowel syndrome in a clinical sample: a randomized controlled trial. BMC Gastroenterol. 2011 Oct 12;11:110. doi: 10.1186/1471-230X-11-110.
Clinical trial NCT00514761: Phase II Efficacy Study of AZD6244 in Colorectal Cancer
Official title: A Phase II, Open, Randomized Study to Assess the Efficacy and Safety of AZD6244 vs Capecitabine (Xeloda) in Patients With Colorectal Cancer Who Have Failed One or Two Prior Chemotherapeutic Regimens.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Colorectal Cancer
Keywords: colorectal cancer
AZD6244
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-08-10
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to assess if there is benefit when using AZD6244 in the treatment if metastatic colorectal cancer in comparison with another treatment called capecitabine. This study will also assess how safe and well tolerated AZD6244 is.


Eligibility criteria: Inclusion Criteria:

* colorectal cancer
* require treatment but have failed one or two previous chemotherapeutic regimens that must have included oxaliplatin and/or irinotecan
* have World Health Organisation (WHO) performance status 0-2 and life expectancy \> 12 weeks

Exclusion Criteria:

* previous therapy with EGFR inhibitor, MEK inhibitor or capecitabine
* any recent surgery, unhealed surgical incision or severe concomitant condition which makes it undesirable for the patient to participate in the study
* nausea and vomiting, chronic gastrointestinal disease or significant bowel resection that would preclude adequate absorption

Primary outcomes:
measure: Progression event count
timeFrame: assessed after each visit
Secondary outcomes:
measure: safety and tolerability
timeFrame: assessed at each visit
Other outcomes:
Locations:
city: Goiania
country: Brazil
facility: Research Site
city: Rio de Janeiro
country: Brazil
facility: Research Site
city: Sao Paulo
country: Brazil
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Clive Morris, MD
role: STUDY_DIRECTOR
affiliation: AstraZeneca
name: Gill Pover, MD
role: STUDY_DIRECTOR
affiliation: AstraZeneca
name: Lance Smith
role: STUDY_DIRECTOR
References:
Clinical trial NCT02884661: First-line Treatment for Atrial Fibrillation in Cardiology and Geriatric Departments
Official title: Assessment of the Usual Choice for a First-line Treatment in Case of Atrial Fibrillation : Comparison Between Cardiology Department and Geriatric Unit.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Centre Hospitalier Régional Metz-Thionville
Sponsor class: OTHER
First posted: 2016-08-31
Enrollment: 100
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with an atrial fibrillation and hospitalized in Cardiology department or in geriatric unit

Brief summary: In order to evaluate the implementation for the recommendations about the patient care for atrial fibrillation in aged patients, a non-interventional study is performed retrospectively by comparing two approach of the focus in Cardiology Department and in Geriatric unit.


Eligibility criteria: Inclusion Criteria:

* having an atrial fibrillation
* cared in Cardiology department or in geriatric unit

Exclusion Criteria:

* having a mitral valvulopathy, or a valvular disease with a surgery indication
* having a valvular prosthesis
* history of valve reconstruction

Primary outcomes:
measure: Implementation of the recommendations about non-valvular atrial fibrillation
timeFrame: September 1st, 2014 to October 13, 2015
Secondary outcomes:
measure: Socio-demographic data
timeFrame: September 1st, 2014 to October 13, 2015
measure: Etiologic factors of the atrial fibrillations
timeFrame: September 1st, 2014 to October 13, 2015
measure: Use of supplementary examinations
timeFrame: September 1st, 2014 to October 13, 2015
measure: Use of a standard geriatric assessment
timeFrame: September 1st, 2014 to October 13, 2015
measure: Use of an assessment of the risks of thrombosis and bleeding
timeFrame: September 1st, 2014 to October 13, 2015
measure: Choice of the anti-thrombosis treatment
timeFrame: September 1st, 2014 to October 13, 2015
measure: Choice of the anti-arrhythmia treatment
timeFrame: September 1st, 2014 to October 13, 2015
Other outcomes:
Locations:
city: Metz Cedex 03
country: France
facility: CHR Metz-Thionville
Study officials:
affiliation: CHR Metz-Thionville
name: NOEL BLETTNER, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03766061: Onlay Mesh Hernioplasty Vs Sublay Mesh Hernioplasty for Paraumbilical Hernia Repair
Official title: Onlay Mesh Hernioplasty Vs Sublay Mesh Hernioplasty for Paraumbilical Hernia Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Paraumbilical Hernia
Lead sponsor: Services Hospital, Lahore
Sponsor class: OTHER_GOV
First posted: 2018-12-05
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It is a randomized controlled trial in which we are comparing onlay mesh hernioplasty with sublay mesh hernioplasty for paraumbilical hernia.


Eligibility criteria: Inclusion Criteria:

* Patients of both sexes and age 20 years and above with paraumblical hernia Defect size 3 to 6cm in greatest diameter

Exclusion Criteria:

* defect size less than 3cm or greater than 6 cm in greatest diameter Obstructed or strangulated hernia Uncontrolled diabetes

Primary outcomes:
measure: Percentage of patients presenting with recurrence of hernia
timeFrame: 8 months
Secondary outcomes:
measure: Postoperative pain from score 1 to 10
timeFrame: 3 days
measure: Hospital Stay duration in days
timeFrame: 1 week
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Services hospital
state: Punjab
Study officials:
affiliation: Services Hospital, Lahore
name: Mahmmood Ayyaz, mbbs, fcps
role: STUDY_DIRECTOR
References:
Clinical trial NCT03703128: Suicide in People Aged 45-60: A Case-control Psychological Autopsy Study
Official title: Psychological Autopsy Study: A Case-control Research Into 45-60 Year Old Suicide Victims in Flanders, Belgium
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Suicide
Keywords: psychological autopsy
prevention
Lead sponsor: University Ghent
Sponsor class: OTHER
Collaborators: name: Flemish Ministry of Welfare, Public Health, and Family, Belgium
First posted: 2018-10-11
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: community sample

Brief summary: The purpose of this study is to learn about the possible causes of the negative trend in suicide rates in both males and females aged 45-60 in Flanders, Belgium. This will be carried out using a psychological autopsy study.

Detailed description: A case-control psychological autopsy study will be carried out to identify what risk factors are related to suicide in people aged 45-60. People close to the person who died by suicide (next of kin or close friends) will be interviewed. To increase the validity of our findings, a control group will also be interviewed. The control group will be someone who is very close to someone with mental health problems.

Eligibility criteria: Inclusion Criteria:

* close to suicide victim or person who has mental health problems
* suicide victim or person with mental health problems was/is 45-60 years old
* the suicide happened more than 3 months and less than 5 years ago

Exclusion Criteria:

* not Dutch-speaking

Primary outcomes:
measure: History of suicidal behaviour (presuicidal communication, method, intent)
timeFrame: baseline
measure: Exposure to suicidal behavior
timeFrame: baseline
measure: Sociodemographics
timeFrame: Baseline
measure: Living situation
timeFrame: Baseline
measure: Work situation
timeFrame: Baseline
measure: Religion
timeFrame: Baseline
measure: Interpersonal relationships (intimate, children, social contact, family)
timeFrame: Baseline
measure: Financial problems
timeFrame: Baseline
measure: Legal problems
timeFrame: Baseline
measure: Life events
timeFrame: Baseline
measure: Medical history
timeFrame: Baseline
measure: Psychiatric history
timeFrame: Baseline
measure: Psychiatric disorders
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Unit for Suicide Research, Ghent University
Study officials:
affiliation: University Ghent
name: Kees van Heeringen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05974228: Bioglass Wound Dressing in Treatment of Chronic Wound in Different Stage：a Randomized Controlled Trial
Official title: Bioglass Wound Dressing in Treatment of Chronic Wound in Different Stage：a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Wound
Keywords: Chronic wound
Bioactive glass
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
Collaborators: name: Yunfeng Li
First posted: 2023-08-03
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this randomized control trial is to test the efficacy and safety of a bioglass wound dressing in patients with chronic wound in different stages. The main question it aims to answer are:

* Whether the bioglass wound dressing have better efficacy and safety than blank control in treatment of chronic wound in necrosis stable stage？
* Whether the bioglass wound dressing have better efficacy and safety than blank control in treatment of chronic wound in granulation growth stage？ Participants will be assigned with a 1:1 ratio into intervention group and control group.

Participants of intervention group will receive bioglass wound dressing in addition with clinical optimal treatment plan. Participants of control group will only receive clinical optimal treatment plan.


Eligibility criteria: Inclusion Criteria:

1. The patient is aged 18-80 years old;
2. Ulcerative wounds;
3. In the stage of stable necrosis or granulation growth;
4. Voluntarily participate in this study and sign an informed consent form

Exclusion Criteria:

1. Severe diseases such as acute myocardial infarction, heart failure, hepatitis, shock, and respiratory failure have not been corrected yet;
2. Uncontrolled blood glucose, Glucose test#Fasting blood sugar\>15mmol/L, Glycated hemoglobin\>12%;
3. There is active bleeding inside the wound, and routine basic treatment plans cannot be implemented;
4. Serum albumin \< 20 g/L; Hemoglobin\<60 g/L; Platelets\<50 × 10\^9/L;
5. Spreading infection status, currently or about to be treated with antibiotics;
6. Patients with advanced malignant tumors;
7. Active period of autoimmune diseases;
8. Previous allergies to bioactive glass ointment dressings (self originating);
9. The patient is unable to cooperate or has mental disorders;
10. According to the judgment of the researcher, the subject has a clear reason that cannot be removed and affects wound healing, which is not suitable for this study or cannot comply with the requirements of this study.

Primary outcomes:
measure: 2-week reduction rate of wound area
timeFrame: 2-week
Secondary outcomes:
measure: 2-week wound healing rate
timeFrame: 2-week
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06299228: Is Sensorimotor Training Effective Following a Distal Radius Fracture?
Official title: Sensorimotor Training and Hand Therapy Versus Traditional Hand Therapy Alone Following a Distal Radius Fracture With Volar Plate Fixation: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Distal Radius Fractures
Lead sponsor: Hand Surgery Associates LLC
Sponsor class: OTHER
Collaborators: name: Touro University Nevada
name: Orthopaedic Specialty Group PC, Fairfield
First posted: 2024-03-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the short-term outcomes of individuals who have surgery (volar plate) for a wrist (distal radius) fracture who have routine hand therapy treatment versus routine hand therapy treatment and sensorimotor activities. Individuals who meet inclusion criteria at the facilities collecting data will be invited to participate. If they agree to participate, they will randomly and blindly (via concealed envelopes) be assigned to the control (routine treatment) or the sensorimotor treatment group. Data collection will occur at 3- and 6-weeks post initiation of skilled therapy and will include measurement of joint position sense, function via the Patient Rated Wrist and Hand, pain via the Numeric Pain Rating Scale, and range of motion at the digits and wrist.

Detailed description: The study is an interventional study investigating the effectiveness of sensorimotor activities in addition to traditional occupational therapy intervention versus traditional intervention only for patients following a distal radius fracture with volar plate fixation. A convenience sample of patients from 2 outpatient orthopedic hand therapy departments will be invited to participate in the study.

The treatment for both groups will be identical with one group receiving the addition of sensorimotor activities. Participants will be divided into one of the two groups. They will be made aware that at any point they can choose to no longer participate in the study, and it will not affect their treatment.

Eligibility criteria: Inclusion Criteria:

* Distal radius fracture with volar plate fixation
* Understand English
* 18 years or older
* Available to attend skilled occupational therapy visits a minimum of 1x per week.

Exclusion Criteria:

* Prior surgery to the involved wrist/hand
* Cognitive impairment
* Distal radius fracture managed by casting or by another means of fixation

Primary outcomes:
measure: Active Joint Position Sense (AJPS)
timeFrame: Baseline, 3 and 6 weeks
Secondary outcomes:
measure: Patient Rated Wrist and Hand Evaluation
timeFrame: Baseline, 3 and 6 weeks
Other outcomes:
Locations:
city: Olyphant
country: United States
facility: Hand Surgery Associates
state: Pennsylvania
Study officials:
References: