louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01397214: Pharmacokinetics of Megace F and Megace OS Under Fasting and Fed Conditions in Healthy Male Volunteers
Official title: A Randomized, Open-label, Single-dose, Cross-over Study to Investigate Safety and Pharmacokinetics of Megace F and Megace OS Under Fasting and Fed Conditions in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cachexia
Anorexia
Lead sponsor: Boryung Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2011-07-19
Enrollment: 103
Sex: MALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Phase I study of Megace F will be conducted to investigate pharmacokinetics and safety compared to Megace OS.

Phase I study divided into 3 parts written as belows.

Part 1 Megace F in fasting volunteers vs Megace F in fed volunteers Part 2 Megace F vs Megace OS in fed volunteers Part 3 Megace F vs Megace OS in fasting volunteers


Eligibility criteria: Inclusion Criteria:

age: 20-55 years body weight: greater than 50kg written informed consent

Exclusion Criteria:

known allergy to Megesterol acute or chronic diseases which could affect drug absorption or metabolism positive drug or alcohol screening smokers of 10 or more cigarettes per day 3 month ago participation in a clinical trial during the last 3 months prior to the start of the study

Primary outcomes:
measure: AUC
timeFrame: 0, 1, 2,3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120 hrs
Secondary outcomes:
measure: Tmax
timeFrame: 0, 1, 2,3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120 hrs
measure: t1/2
timeFrame: 0, 1, 2,3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120 hrs
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Kyung-sang Yu, Dr.
role: STUDY_CHAIR
References:
Clinical trial NCT05763914: A 24-week Single-blind Trial of Prevention of Hand Eczema in Cleaners
Official title: Hand Eczema in Cleaners: a Randomized Clinical Trial of Picture-based Prevention Compared to Treatment as Usual Among Professional Hospital Cleaners
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hand Eczema
Keywords: Prevention
Occupational
Picture
Cleaning
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
name: Danish Working Environment Fund
First posted: 2023-03-10
Enrollment: 234
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A cluster-randomized clinical trial, including three different hospitals. At each hospital, 78 cleaners will be included.
Primary purpose: PREVENTION

Brief summary: This study aims to investigate the effectiveness of picture-based prevention education among professional hospital cleaners in relation to hand eczema. This is a single-blinded randomized clinical trial including hospital cleaners at three different hospitals.


Eligibility criteria: Inclusion Criteria:

* Professional hospital cleaners ≥ 18 years old
* Sufficient Danish skills
* Written informed consent

Exclusion Criteria:

* Insufficient Danish skills
* Pregnancy
* Other skin diseases on the hands
* Receiving Immunomodulatory therapies

Primary outcomes:
measure: Incidence rate of hand eczema
timeFrame: Change between baseline and 6 months
measure: Hand Eczema Severity Index (HECSI)
timeFrame: Change between baseline and 6 months
Secondary outcomes:
measure: Rate of absence from work due to having hand eczema
timeFrame: Change between baseline and 6 months
measure: Rate of participants being forced to change their job due to having hand eczema (questionnaire-based).
timeFrame: Change between baseline and 6 months
measure: The Quality Of Life in Hand Eczema Questionnaire (QqlHEQ)
timeFrame: Change between baseline and 6 months
measure: Rate of knowledge regarding skin care and protection.
timeFrame: Change between baseline and 6 months
Other outcomes:
Locations:
city: Køge
country: Denmark
facility: Cleaning departments at Køge, Slagelse and Holbæk hospitals
state: Zealand Region
Study officials:
affiliation: Zealand University Hospital
name: Kristina Sophie Ibler, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04276714: Revofit™ System Evaluation on Residual Limb Pain in Amputee Patients
Official title: Revofit™ System and Residual Limb Pain in Amputee Patients : Multiple N-of-1 Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Amputation
Adult Disease
Keywords: residual limbs
pain
adjustable socket
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2020-02-19
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Single Case Experimental Design : multiple N of 1 trial
Primary purpose: TREATMENT

Brief summary: At the early stage of the amputation, the residual limb presents post-surgical fluctuations related to post-operative phase, which would need a frequent prosthetic adjustment. In most cases, the volume of residual limb is constant from 12 to 18 months after surgery. However, some daily fluctuations could appear due to an underlying vascular disease for example, which could be painful and impact the quality of life with a constant need of prosthetics adjustment. The goal of this study is to assess the effectiveness of a system-adjusted fitting in comparison with a standard fitting.

Detailed description: With the " multiple N-of-1 trial " study type, pain, quality of life, functional effects and the patient satisfaction with assistive technology will be assessed for four weeks.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18 years old and above
* Above knee or below knee amputation (irrespective of etiology and time from amputation)
* Residual limb pain
* Prosthetic with classic fitting
* Fluctuations of residual limb requiring prosthetic adaptation (stump cotton sock, wedgning fitting ...)
* Recipients or registered with a social security scheme
* Informed consent form signed beforehand

Exclusion Criteria:

* Patient with peripheral neuropathies contraindicating the use of Revofit system
* Pregnant woman, nursing mother or parturiant
* Patient in detention by judicial or administrative decision
* Patient undergoing psychiatric compulsory care
* Patient in a health or social institution for purposes other than research
* Legally protected person
* Patient unable to express their consent

Primary outcomes:
measure: Pain change assessment
timeFrame: four weeks
Secondary outcomes:
measure: Everyday comfort
timeFrame: four weeks
measure: Functional effects in twin task
timeFrame: Once a week during four weeks
measure: Functional effects in simple task
timeFrame: Once a week during four weeks
measure: Patient satisfaction with assistive technology
timeFrame: Once a week during four weeks
Other outcomes:
Locations:
city: Angers
country: France
facility: DIMONAIS
Study officials:
affiliation: MD University hospital Angers
name: Mickaël Dinomais
role: PRINCIPAL_INVESTIGATOR
affiliation: MD
name: Yoann RONZI
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02344914: Dental Support and the Second Stage of Labor Among Multiparous Women
Official title: Dental Support and the Second Stage of Labor Among Multiparous Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Second Stage of Labor
Keywords: dental support
second stage of labor
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2015-01-26
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess if the use of the dental support device( DSD) Laboraide™ shortens the second stage of labor and decreased the rate of obstetrical interventions, and if it's use alleviate pain.

Detailed description: Several studies have demonstrated that a dental support device (DSD) may increase the isometric strength of different muscle groups (1-7). A preliminary pilot study of 32 women in 2009 showed that DSD may shorten the second stage of labor among nulliparous women (8) by increasing the expulsive efforts of the parturient. The study hypothesis was that DSD may decrease the length of the second stage of labor and decrease the need for obstetrical interventions such as cesarean delivery or operative vaginal delivery.

The Laboraide™ is a DSD developed specifically for use during labor. It is an inert device located between the jaws and does not interfere with speaking, breathing or any other oral activity during labor. It is a single use device, and is not transferred between women. We hypothesize that using this device can shorten the second stage of labor and decrease obstetrical intervention rate. We will also investigate it's efficiency in pain management.

Eligibility criteria: Inclusion Criteria:

1. Singleton gestation
2. Multiparous women
3. Term gestation (\>37+0/7 weeks)
4. Signed written consent to participate in the study
5. Maternal age 18-45 years
6. Normal vital signs
7. Noraml cardiotocography and biophysical profile at admission

Exclusion Criteria:

1. Multiple gestation
2. Nulliparous women
3. preterm gestation (\<37+0/7 weeks)
4. Refusal to participate
5. Maternal age \<18 or \> 45 years
6. Normal vital signs
7. Abnormal cardiotocography and biophysical profile at admission

Primary outcomes:
measure: Duration of the second stage of labor.
timeFrame: 12 month
measure: Mode of delivery.
timeFrame: 12 month
measure: VAS pain score.
timeFrame: 12 month
Secondary outcomes:
Other outcomes:
Locations:
city: Petah tikva
country: Israel
facility: Rabin Medical Center
city: Petah Tikva
country: Israel
facility: Rabin Medical Center
Study officials:
affiliation: Director, Division of obstetrics and delivery
name: Yariv Yogev, professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03882814: Pethidine Analgesia on Labor Duration
Official title: The Effect of Pethidine Analgesia on Labor Duration and Maternal-Fetal Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Labor Pain
Keywords: Analgesia
labor
pethidine
Active Phase
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
Collaborators: name: Gaziosmanpasa Research and Education Hospital
First posted: 2019-03-20
Enrollment: 240
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inclusion criteria were nulliparous and multiparous patients with singleton pregnancies between 37 and 41 completed weeks (according to last menstrual period).

Brief summary: Although opioid analgesics are used to treat labor pain, there are still concerns about their side effects.

The researchers in this study; aimed to evaluate the effect of pethidine on active phase duration of labor, labor pain and maternal-neonatal.

50 mg pethidine will be administered intramuscularly to the cases to be included in the study group. The patients in the control group will be given placebo injections.

Vital signs of all cases included in the study will be checked at 0, 5, 15, 30, 45 and 60 minutes. Pain will also be assessed by Visual Analogue Scale (VAS) before injection and at the 1st and 2nd hour after injection. Delivery times, maternal side effects, neonatal apgar scores and fetal findings will be recorded.


Eligibility criteria: Inclusion Criteria:

* nullipar-multiparous patients;
* singleton pregnancies 37- 41 weeks (by the last menstrual period).

Exclusion Criteria:

* maternal respiratory rate \< 8 /min,
* maternal bradycardia (\<60 bpm),
* major fetal congenital anomalies,
* uterine scar presence from previous pregnancies,
* malpresentation,
* antepartum hemorrhage,
* multiple pregnancy,
* labor induction,
* chronic systemic disease,
* rupture fetal membranes,
* epidural analgesia.

Primary outcomes:
measure: Active phase of labor with pethidine
timeFrame: during labor
measure: Labor pain with pethidine
timeFrame: during labor
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kanuni Sultan Süleyman Training and Research Hospital
Study officials:
References:
citation: Kadirogullari P, Yalcin Bahat P, Sahin B, Gonen I, Seckin KD. The Effect of Pethidine Analgesia on Labor Duration and Maternal-Fetal Outcomes. Acta Biomed. 2021 May 12;92(2):e2021065. doi: 10.23750/abm.v92i2.10905.
Clinical trial NCT02909114: Stereotactic Body Radiotherapy for Oligometastases From Colorectal Cancer
Official title: Phase II Study of Stereotactic Body Radiotherapy for Oligometastases From Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Colorectal Cancer
Keywords: stereotactic boday radiotherapy, oligometastases
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2016-09-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Single arms prospective phase II study of SBRT for oligometastatases from colorectal cancer

Detailed description: Single arms prospective phase II study of SBRT for oligometastatases from colorectal cancer, the primary concerns are treatment efficacy and toxicities.

Eligibility criteria: Inclusion Criteria:

* 18-75 years
* Eastern Cooperative Oncology Group (ECOG) performance score ≤ 1
* Diagnosis by pathological examination
* Primary lesion is under control by surgery
* Adequate blood counts:

  * White blood cell count ≥3.5 x 109/L
  * Haemoglobin levels ≥100g/L
  * Platelet count ≥100 x 109/L
  * Creatinine levels ≤1.0× upper normal limit (UNL)
  * Urea nitrogen levels ≤1.0× upper normal limit (UNL)
  * Alanine aminotransferase (ALT) ≤1.5× upper normal limit (UNL)
  * Aspartate aminotransferase (AST) ≤1.5× upper normal limit (UNL)
  * Alkaline phosphatase (ALP) ≤1.5× upper normal limit (UNL)
  * Total bilirubin (TBIL) ≤1.5× upper normal limit (UNL)

Exclusion Criteria:

* Primary lesion is not under control
* Pancreatic carcinoma
* Oligometastases could not be located
* Pregnancy or breast feeding
* Symptoms or history of peripheral neuropathy

Primary outcomes:
measure: local control assessed by RECIST
timeFrame: 3 years
Secondary outcomes:
measure: >= Grade 3 treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: from radiotherapy start to complete treatment 90 days
measure: overall survival
timeFrame: 3 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital Chinese Acadamy of Medical Sciences
state: Beijing
Study officials:
References:
Clinical trial NCT00116714: Rheumatoid Arthritis (DMARD) Intervention and UtilizationStudy
Official title: Rheumatoid Arthritis Disease Modifying Anti-Rheumatic Drug (DMARD) Intervention and Utilization Study (RADIUS 1)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Keywords: rheumatoid arthritis
RA
DMARD
Lead sponsor: Amgen
Sponsor class: INDUSTRY
Collaborators: name: Immunex Corporation
name: Wyeth is now a wholly owned subsidiary of Pfizer
First posted: 2005-07-01
Enrollment: 4968
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with RA according to ACR criteria, and who are starting, adding or changing DMARD therapy, including biologics.

Brief summary: The Rheumatoid Arthritis DMARD Intervention and Utilization Study (RADIUS 1) is designed to systematically collect and document use patterns, effectiveness, and safety of DMARD treatments currently used in the management of rheumatoid arthritis (RA). It is anticipated that study data may help improve the quality of information upon which clinical decisions are based.


Eligibility criteria: Inclusion Criteria:

* Fulfillment of the 1987 American Rheumatism Association criteria for RA
* Currently requiring a new DMARD (change or addition)

Exclusion Criteria:

* Currently enrolled in a clinical trial with treatments or patient visits imposed by a protocol
* Nursing or pregnant women
* Patients with active infection

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Gibofsky A, Palmer WR, Keystone EC, Schiff MH, Feng J, McCroskery P, Baumgartner SW, Markenson JA. Rheumatoid arthritis disease-modifying antirheumatic drug intervention and utilization study: safety and etanercept utilization analyses from the RADIUS 1 and RADIUS 2 registries. J Rheumatol. 2011 Jan;38(1):21-8. doi: 10.3899/jrheum.100347. Epub 2010 Oct 15.
Clinical trial NCT00517114: Prospective Double-blinded Randomized Controlled Trial of 12-weeks High Dose Rabeprazole (Pariet) in the Treatment of Reflux Laryngitis in Chinese Patients
Official title: Prospective Double-blinded Randomized Controlled Trial of 12-weeks High Dose Rabeprazole (Pariet) in the Treatment of Reflux Laryngitis in Chinese Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastroesophageal Reflux
Laryngitis
Keywords: Reflux laryngitis
Lead sponsor: Hospital Authority, Hong Kong
Sponsor class: OTHER_GOV
Collaborators: name: The University of Hong Kong
First posted: 2007-08-16
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy of rabeprazole (pariet) versus placebo in treating reflux laryngitis in Chinese patients. Patients who attend the voice clinic of Department of ENT, Queen Mary hospital with suspected reflux laryngitis will be recruited. A questionnaire will be administered by the research assistant of the Department of Medicine and ENT, Queen Mary hospital. A 12-week course of PPI versus placebo trial will be commenced and patients' symptoms and signs will be documented at 6-week and 12-week time. The study will finish after a 12-week course of rabeprazole.


Eligibility criteria: Inclusion Criteria:

* Ambulatory patients with age between 18-80 years old
* Patients with newly presented laryngitis.

Exclusion Criteria:

* They were under 18 or over 80 years of age
* Has significant concomitant medical disease
* Pregnancy or lactating women
* Chronic cough attributable to known chronic pulmonary or tracheobronchial disease
* Previous glottal surgery, radiotherapy or malignancy
* Acid suppressive therapy within 4 wk prior to recruitment
* Pharyngo-laryngeal infection in the previous 3 months
* Tracheal intubation in previous 12 months
* Immunosuppression and use of inhaled corticosteroid

Primary outcomes:
measure: Symptoms assessment, quality of life.
timeFrame: 12 weeks
Secondary outcomes:
measure: Compliance
timeFrame: 4 weeks
measure: Adverse effects
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Queen Mary Hospital
Study officials:
affiliation: Department of Medicine, Queen Mary Hospital/ The University of Hong Kong
name: Paul KY Lam, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04681014: CTEPH in Patients With Prior Pulmonary Embolism and Risk Score Validation
Official title: Evidence-based Detection of CTEPH in Patients With Prior Pulmonary Embolism: Risk Score Evaluation and Validation.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Thromboembolic Pulmonary Hypertension
Pulmonary Embolism
Lead sponsor: iPHNET (italian Pulmonary Hypertension NETwork)
Sponsor class: OTHER
First posted: 2020-12-23
Enrollment: 1218
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with prior pulmonary embolism followed by centres for anticoagulant therapy management (TAO centres) will be enrolled by the investigator's centres and undergo baseline evaluation for prevalent CTEPH detection; al CTEPH will be confirmed by right heart catheterization.

Brief summary: CTEPH-SOLUTION aims to create a risk score for the early detection of Chronic Thrombo-Embolic Pulmonary Hypertension (CTEPH) among patients with previous pulmonary embolism.

The risk score, created on retrospective data, will be validated on newly diagnosed pulmonary embolism patients.

Detailed description: CTEPH-SOLUTION is a multicenter observational cross-sectional and prospective study in patients with a prior and new diagnosis of pulmonary embolism.

Patients with prior pulmonary embolism will be screened at baseline with doppler echocardiography: an estimated sPAP ≥ 40 mmHg will be the indication for pulmonary hypertension detection. After 24 months from baseline, patients will be followed-up for CTEPH detection. CTEPH diagnosis will be carried out according to the current ESC/ERS guidelines.

Incident (pulmonary embolism episode at least three months before the baseline) and prevalent (pulmonary embolism episode) patients will be enrolled.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 at baseline evaluation
* Diagnosis of prior (\> 30 days from pulmonary embolism onset) or new-onset pulmonary embolism, according to the ESC guidelines on the diagnosis and management of acute pulmonary embolism

Exclusion Criteria:

* patients without pulmonary embolism diagnosis

Primary outcomes:
measure: CTEPH-SOLUTION score
timeFrame: 24 months
Secondary outcomes:
measure: The number of the subject with a diagnosis of CTEPH on the total number of subjects enrolled.
timeFrame: 24 months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Department of Clinical, Internal, Anesthesiological and Cardiovascular Sciences. AOU Policlinico Umberto I
Study officials:
References: