louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03659149: Pharmacokinetics and Safety Profile of CKD-333
Official title: An Open-label, Randomized, Fasted, Single-dose, Three-way Crossover Study to Compare the Pharmacokinetics and Safety Between Administration of CKD-333 and Coadministration of CKD-330 and D086 in Healthy Male Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypertension
Dyslipidemias
Keywords: Hypertension
Dyslipidemias
CKD-333
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2018-09-06
Enrollment: 37
Sex: MALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Compare the pharmacokinetic characteristics and safety between CKD-333 tablet and CKD-330, D086 combination

Detailed description: An open-label, randomized, fasted, single-dose, three-way crossover study to compare the pharmacokinetic characteristics and safety between administration of CKD-333 and coadministration of CKD-330 and D086 in healthy male adults

Eligibility criteria: Inclusion Criteria:

1. Between 19 aged and 45 aged in healthy male adult
2. Body weight more than 50kg and within ideal body weight ±20%

Exclusion Criteria:

1. Have clinical significant medical history or disease that cardiovascular system, respiratory system, kidney, endocrine system, hematological system, digestive system , mental illness
2. Have a gastrointestinal disease history that can effect drug absorption or surgery
3. SBP(Systolic Blood pressure)≥140mmHg or SBP\<90mmHg, DBP(Diastolic Blood Pressure(≥90mmHg or DBP\<60mmHg

Primary outcomes:
measure: AUCt(Area under the plasma drug concentration-time curve) PK of Candesartan, Amlodipine, Atorvastatin
timeFrame: 0~72hours
measure: Cmax(Maximum plasma concentration of the drug in plasma) of Candesartan, Amlodipine, Atorvastatin
timeFrame: 0~72hours
Secondary outcomes:
measure: AUCinf(Area under the plasma concentration-time curve from time t to infinity) of Candesartan, Amlodipine, Atorvastatin, 2-hydroxy-atorvastatin
timeFrame: 0~72hours
measure: Tmax(Time to reach the maximum concentration) of Candesartan, Amlodipine, Atorvastatin, 2-hydroxy-atorvastatin
timeFrame: 0~72hours
measure: t1/2(Time for Cmax to drop in half) of Candesartan, Amlodipine, Atorvastatin, 2-hydroxy-atorvastatin
timeFrame: 0~72hours
measure: CL/F(Apparent clearance) of Candesartan, Amlodipine, Atorvastatin, 2-hydroxy-atorvastatin
timeFrame: 0~72hours
measure: Vd/F(Apparent volume of distribution) of Candesartan, Amlodipine, Atorvastatin, 2-hydroxy-atorvastatin
timeFrame: 0~72hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul Saint Mary's Hospital
Study officials:
affiliation: Department of Clinical Pharmacology, Seoul ST.Mayr's Hospital
name: Seunghun Han, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03585049: Microscopic Images for the Development of a Rapid Vaginitis Diagnostic Device
Official title: Archive of Vaginal Swabs Microscopic Images for the Development of a Rapid Vaginitis Diagnostic Device
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vaginitis
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2018-07-12
Enrollment: 500
Sex: FEMALE
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: All patients above 18y that go through a routine vulvovaginal assessment at the clinic

Brief summary: The study goal is to create an archive of microscopy images of various vulvovaginal inflammation conditions

Detailed description: During the study, the investigators are planning to make a secondary use of vaginal discharge samples that are primarily taken for routine wet mount microscopic diagnostics in a vulvovaginal clinic at the Women's health center, Ramat-Eshkol, Jerusalem.

In order to create an anonymous archive of digital microscopy images, before each swab is disposed of, the investigator will dilute the collected discharge on the swab with 0.5ml Saline into an Eppendorf tube. The diluted discharge will then be applied onto the GynTools LTD VagX tray that is then scanned by a tabletop scanner. At this point the VagX tray will be washed with water, soap and both the swab and tube will be disposed of.

No of participating patients: 1000 Patients age: 18 years and above. Only from patients capable of signing an informed consent.

Eligibility criteria: Inclusion Criteria:

Vulvovaginal complaints

Exclusion Criteria:

Younger than 18y or cannot sign an informed consent form

Primary outcomes:
measure: Creation of microscopy image archive
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Clalit Women's Health Center
Study officials:
affiliation: Clalit Healthcare Services
name: Ahinoam LevSagie, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06675149: Diacutaneus Fibrolysis on Tempromandibular Joint Pain and Trismus Post Oral Surgery
Official title: Effect of Diacutaneus Fibrolysis on Tempromandibular Joint Pain and Trismus Post Oral and Maxillofacial Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Temporomandibular Pain
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-11-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is carried out on sixty patients who will have tempromandibular pain and trismuspostOral and Maxillofacial Surgeryand their ages will be ranged from 18 to 40 years.


Eligibility criteria: Inclusion Criteria:

1. Ages of patients will be ranged from 18 to 40 years.
2. All patients will have Oral and Maxillofacial Surgery.
3. All patients will be referred by a surgeon before starting the study procedure.
4. All participants will have pain and trismus in the jaw,
5. The participants will be also cleared for periodontal issues.
6. All patients will enter the study having their informed consent

Exclusion Criteria:

1. Patients with associated vascular injuries requiring arterial repair.
2. Patient with systemic diseases such as arthritis; pain attributable to confirmed migraine, head, or neck pain condition
3. Patient with acute infection or other significant disease of the teeth, ears, eyes, nose, or throat
4. Patient with present neurologic or cognitive deficit.
5. Patients with history of previously failed surgeries.

Primary outcomes:
measure: temporomandibular joint pain
timeFrame: pre intervention and re assessed after 1 month
measure: Trismus
timeFrame: pre intervention and re assessed after 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo University
Study officials:
References:
Clinical trial NCT01042249: Pelvic Floor Muscle Training(PFMT) on Lower Urinary Tract Symptoms (LUTS) in Men With Stroke
Official title: The Effect of Pelvic Floor Muscle Training on Lower Urinary Tract Symptoms (LUTS) in Men With Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Male
Stroke
Urinary Incontinence
Keywords: PFMT
Stroke
LUTS
Men
Lead sponsor: Glostrup University Hospital, Copenhagen
Sponsor class: OTHER
Collaborators: name: Fondation of 18.12.1981
First posted: 2010-01-05
Enrollment: 31
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the effect of pelvic floor muscle training (PFMT) on Lower Urinary Tract Symptoms (LUTS) in men after stroke.

120 men with LUTS or increased LUTS after stroke is included and randomized into a treatment group or a control group. The subjects in the treatment group follows a 12 week standard PFMT program, while the control group is not given specific treatment of their LUTS but like the treatment group follows the standard rehabilitation program for stroke patient. Outcome are measured by

* 5 questionnaires
* Voiding diary
* 24-hour pad test
* pelvic floor muscle assessment test


Eligibility criteria: Inclusion Criteria:

1. Men, diagnosed with stroke clinical defined according World Health Organisation (WHO 1989) and confirmed by CT and MRI scan
2. Onset of last stroke ≥ 1 month
3. Normal cognitive function (minimal mental examination score \> 25 ) (Folstein, Folstein et al. 1976).
4. LUTS according to ICS definition (Abrams, Cardozo et al. 2002), with start or aggravation in close relation to the stroke
5. Independent walking abilities indoor \> 100 m with/without aids
6. Independence in toilet visits
7. Age \> 18 years

Exclusion Criteria:

1. Prior history of LUTS surgery, pelvic surgery or trauma
2. More than 2 hospital diagnosed stroke
3. Other severe neurological diseases including dementia
4. Severe dysphasia
5. Severe psychiatric disease
6. Prostate cancer
7. Do not speak Danish or English

Primary outcomes:
measure: DAN-PSS-1 questionnaire
timeFrame: 2010-2012
Secondary outcomes:
measure: Pelvic Floor Muscle Assessment test
timeFrame: 2010-2012
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Dept. of physiotherapy and occupational therapy, Glostrup University Hospital, Copenhagen
Study officials:
References:
Clinical trial NCT02719249: Fabry Disease Screening in ESRD Patients in West of France
Official title: Fabry Disease Prevalence in End-stage Renal Disease (ESRD) Patients on Dialysis or Transplant in West of France
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ESRD
Keywords: ESRD
Fabry disease
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2016-03-25
Enrollment: 500
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: End-stage renal disease patients

Brief summary: Screening of Fabry disease in end-stage renal disease (ESRD) patients on dialysis or transplant in west of France.

Detailed description: Detection of Fabry disease is done by dried blood spot test, in dialyzed and transplanted men, who reached ESRD for vascular or unknown disease and were not previously screened.

Eligibility criteria: Inclusion Criteria:

* Men less than 70 years old
* ESRD treated by dialysis or kidney graft in one of the 4 following regions : Bretagne, Centre, Pays de la Loire and Poitou-Charentes
* For unknown nephropathy OR vascular nephropathy and/or diabetic nephropathy unproved by biopsy
* Agreeing freely to participate in the study

Exclusion Criteria:

* Men less than 18 years old
* Persons subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty.

Primary outcomes:
measure: To detect Fabry disease by dried blood spot test, in dialyzed and transplanted men, who reached ESRD for vascular or unknown disease and were not previously screened
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU de Rennes
Study officials:
References:
Clinical trial NCT04228549: MyPADMGT Support of Out-Patients With Peripheral Arterial Disease
Official title: My Peripheral Arterial Disease Management (MyPADMGT) Support of Out-Patients With Peripheral Arterial Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Peripheral Arterial Disease
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2020-01-14
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigators have developed an online program to help people with peripheral arterial disease (PAD) in their extremities to better self-manage their condition. Some earlier testing has been done and the investigators now wish to try this system with participants who have this blood vessel disease as well as high blood pressure. Investigators are hoping to help these participants to achieve healthier lifestyles and improve their quality of life through education, monitoring and continuing support. A similar online desk-top version with over 30 participants has been tested at St. Michael's Hospital in Toronto. The investigators propose to test this newer mobile system with 210 outpatient participants from Hamilton General Hospital. Data collected will be analyzed following the (12 months for each participant) study, along with data recorded during clinical visits at baseline and twelve months for each participant. The objective is to evaluate changes to participant health and determine whether the health self-management process has been successful in improving participant lifestyles and quality of life, when compared to usual care.


Eligibility criteria: Inclusion Criteria:

* Out-patients with Peripheral Arterial Disease (Ankle Brachial Index \< 0.90)
* Attending the Hamilton General Hospital Outpatient Vascular Clinic
* May be living alone or with one or more caregivers
* Must have Internet access.

Exclusion Criteria:

* Age \< 18 years
* Not diagnosed with PAD
* Unable to communicate in English
* Unwilling to participate
* Patients with dementia.

Primary outcomes:
measure: Systolic Blood Pressure
timeFrame: 1 Year
measure: EQ-5D-5L Quality of Life Visual Result
timeFrame: 1 Year
Secondary outcomes:
measure: Ankle Brachial Index
timeFrame: 1 year
measure: Body Weight
timeFrame: 1 year
measure: Social Isolation
timeFrame: 1 year
measure: Smoking Cessation
timeFrame: 1 year
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: General Hospital
state: Ontario
Study officials:
affiliation: McMaster University
name: Michael Stacey, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04497649: Sofosbuvir Containing Regimens in Treatment of COVID 19 Patients
Official title: Sofosbuvir Containing Regimens in Treatment of COVID 19 Patients: A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Covid19
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2020-08-04
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: efficacy and safety of Sofosbuvir containing regimens in treatment of COVID-19 Egyptian patients,

Detailed description: The study aims to assess Sofosbuvir containing regimens in treatment of COVID-19 Egyptian patients,

Eligibility criteria: Inclusion Criteria:

* COVID 19 positive patients

Exclusion Criteria:

* COVID-19 patients with critical manifestations.
* Sepsis.
* Acute respiratory distress syndrome (ARDS).
* Decompensated liver disease (Child-Pugh class B or C disease).
* Chronic renal impairment.
* Patients with blood diseases (severe anemia, thalassemia, ITP, leukemia ....).
* Ischemic heart disease within the last 6 months.
* Chronic pulmonary disease.
* Malignancy.
* Pregnancy or breastfeeding.
* Hypersensitivity to sofosbuvir or ribavirin.
* Patients with organ transplant.
* Unwilling to participate in our study

Primary outcomes:
measure: Number of patients with improvement or mortality
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Cairo and Tanta Universitities
Study officials:
affiliation: Tanta University - Faculty of Medicine
name: Marwa Salama, Lecturer
role: PRINCIPAL_INVESTIGATOR
affiliation: Tanta University Faculty of medicine
name: sherief Abd-Elsalam, ass. Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Ahmed Cordie, lecturer
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Gamal Esmat, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06646549: Insomnia in Postmenopausal Osteoporosis
Official title: The Association of Insomnia With Fatigue and Mood in Postmenopausal Osteoporosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoporosis
Lead sponsor: Beylikduzu State Hospital
Sponsor class: OTHER
First posted: 2024-10-17
Enrollment: 200
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Women diagnosed with postmenopausal osteoporosis.

Brief summary: Aim of the study was to determine the presence of sleep problems in postmenopausal osteoporosis patients and to examine the relationship between the severity of insomnia and mood and fatigue. Pain, sleep problems, depression, anxiety, and fatigue were assessed using appropriate scales

Detailed description: The research was planned as a clinical cross-sectional study. Two hundred women, aged between 50-75 years, who were diagnosed with postmenopausal osteoporosis and followed up in the outpatient clinics of Beylikdüzü State Hospital and Istanbul Physical Medicine and Rehabilitation Training and Research Hospital between May 19, 2024, and June 19, 2024, were included. Sociodemographic data such as gender, height, weight, body mass index, educational status, and occupation were recorded. The date of osteoporosis diagnosis, history of falls within the last 6 months, presence of fractures due to low-energy trauma, osteoporosis treatment, medications used, and comorbidities were questioned. The presence and location of pain were asked, and if pain was present, its intensity was determined using the Visual Analog Scale. Calcium and vitamin D levels from the last 3 months were recorded. The patient's sleep problems were assessed using the Insomnia Severity Index. Subsequently, the patient's current depression and anxiety-related symptoms were measured using the Hospital Anxiety and Depression Scale (HADS), and the fatigue level was assessed with the Fatigue Severity Scale (FSS).

Eligibility criteria: Inclusion Criteria:

* Women diagnosed with postmenopausal osteoporosis.
* Patients who agreed to participate in the study.
* Age range between 50-75 years.

Exclusion Criteria:

* Presence of fibromyalgia.
* Chronic fatigue syndrome.
* Chronic decompensated cardiac, renal, or hepatic failure.
* Known psychiatric disorders.
* Rheumatological diseases.
* Presence of other known neurological diseases.
* Use of medications that enhance physical performance or alleviate fatigue.

Primary outcomes:
measure: Insomnia Severity Index
timeFrame: 0 day
Secondary outcomes:
measure: Fatigue Severity Scale
timeFrame: 0 day
measure: Hospital Anxiety and Depression Scale
timeFrame: 0 day
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Beylikdüzü State Hospital
state: Beylikdüzü
city: Istanbul
country: Turkey
facility: Beylikdüzü State Hospital
Study officials:
affiliation: Beylikdüzü State Hospital
name: Büşra Şirin Ahısha, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04339049: Comparative Efficacy of Lidocaine Spray Versus Vaginal Misoprostol in IUD Insertion
Official title: Comparative Efficacy of Lidocaine Spray Versus Vaginal Misoprostol in Reducing Pain During IUD Insertion in Adolescents and Nulliparous Women: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Contraception
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Algazeerah hospital
First posted: 2020-04-08
Enrollment: 147
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: the aim of the present study is to compare the safety and efficacy of lidocaine spray versus misoprostol in reducing pain during IUD insertion in adolescents and nulliparous women


Eligibility criteria: Inclusion Criteria:

* adolescent and young nulliparous women requesting IUD insertion

Exclusion Criteria:

* multiparous women, contraindications to IUD insertion or to study drugs

Primary outcomes:
measure: pain during IUD insertion
timeFrame: 5 minutes
Secondary outcomes:
measure: duration of IUD insertion
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Ahmed Ashour
Study officials:
References:
Clinical trial NCT02035449: Video Laryngoscopy in Pre-hospital Critical Care
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Airway Morbidity
Airway Disease
Respiratory Insufficiency
Respiratory Failure
Keywords: Video laryngoscope
Pre-hospital
Endotracheal intubation
Difficult endotracheal intubation
Pre hospital Critical care
McGrath MAC
Airway device
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2014-01-14
Enrollment: 150
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients in the Central Region of Denmark where the anaesthesiologists on the participating pre-hospital critical care teams attempt prehospital endotracheal intubation.

Brief summary: Difficult conditions and critically ill and injured patients may complicate endotracheal intubation in the pre-hospital setting. The incidence of complications increase when two or more endotracheal intubation attempts are needed.

The aim of this study is to estimate the incidence of difficult pre-hospital endotracheal intubation after the introduction of the McGrath MAC Video laryngoscope as the primary airway device for pre-hospital endotracheal intubation.

Hypothesis:

• In our pre-hospital critical care teams, staffed with experienced anaesthesiologists, the rate of difficult PHETI (defined as more than one intubation attempt needed to secure a patent airway) is lower than 10 %, when using the McGrath MAC VL as primary choice in pre-hospital intubations.


Eligibility criteria: Inclusion Criteria:

* Patients where the anaesthesiologists on the participating pre-hospital critical care teams attempt prehospital endotracheal intubation.

Exclusion Criteria:

* Patients\< 15 years of age

Primary outcomes:
measure: The incidence of difficult pre-hospital endotracheal intubation
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Pre-hospital Medical Services, Central Denmark Region
Study officials:
affiliation: Pre-hospital Medical Services, Central Denmark Region
name: Mads P Vandborg, Doctor
role: PRINCIPAL_INVESTIGATOR
References: