louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01152736: Pharmacokinetics With a New Oral Nicotine Replacement Product and Nicorette® Gum
Official title: Single-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product and Nicorette® Gum. A Study in Healthy Smokers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Dependence
Keywords: Smoking Cessation, Nicotine pharmacokinetics
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2010-06-29
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Single-dose pharmacokinetics with a new oral nicotine replacement product and Nicorette® gum.

Detailed description: The study is a single-dose, randomized, cross-over study. The investigational products will be given as single doses at separate visits. The product administrations comprise 30 minutes of chewing. Periods without Nicotine Replacement Therapy (NRT), lasting for at least 36 hours, will separate treatment visits. Before and after the start of product administration at each treatment visit, blood will be sampled for pharmacokinetic analyses, pre-dose, and during 8 hours after start of product administration. Used gums will be collected and analyzed to determine the amount of remaining nicotine. Subjects will also be monitored to capture any adverse events that may occur. Treatment labels will be concealed from subjects, study personnel, monitor, and analysts.

Eligibility criteria: Inclusion Criteria:

* Healthy subjects, smoking at least 10 cigarettes daily during at least one year preceding inclusion and BMI between 17.5 and 30.0 kg/m2.
* Female participants of child-bearing potential are required to use a medically acceptable means of birth control.
* A personally signed and dated informed consent document, indicating that the subject has been informed of all pertinent aspects of the study.

Exclusion Criteria:

* Pregnancy, lactation or intended pregnancy.
* Treatment with an investigational product or donation or loss of blood within 3 month preceding the first dose of study medication.

Primary outcomes:
measure: Pharmacokinetic measurements
timeFrame: Baseline and during 8 hours after product administration
Secondary outcomes:
measure: tmax
timeFrame: Baseline and during 8 hours after product administration
measure: Lamda z
timeFrame: Baseline and during 8 hours after product administration
measure: Released amount of nicotine
timeFrame: After 30 minutes of chewing
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: McNeil AB Clinical Pharmacology R&D
Study officials:
affiliation: McNeil AB
name: Elisabeth Kruse, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05130736: Rehabilitation Robot in Patients With Post-Coronavirus Disease (COVID-19) Fatigue Syndrome
Official title: The Use of a Rehabilitation Robot in Patients With Post-COVID-19 Fatigue Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post-Viral Fatigue Syndrome
Lead sponsor: Poznan University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: EGZOTech sp. z o.o.
name: Szpital Wojewódzki w Poznaniu
First posted: 2021-11-23
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of the study is to compare the effectiveness of two models of rehabilitation:

* traditional neurological rehabilitation, and
* neurological rehabilitation combined with a rehabilitation robot (Luna by EGZOTech).

An additional goal is to test the qualitative diagnostic reference using the surface electromyogram of the Luna robot (certified as a Medical Device) for functional diagnostics based on standardized clinical tests.


Eligibility criteria: Inclusion Criteria:

- patients discharged from Intensive Care Units after undergone ventilator therapy due to COVID-19

Exclusion Criteria:

* active medical condition (infections; tumors; rheumatological, metabolic, endocrine, autoimmunological, cardiovascular diseases)
* bipolar disorder
* dementia
* nutritional disorders
* addiction to alcohol or psychoactive substances
* severe obesity
* overtraining

Primary outcomes:
measure: Change in muscle fatigue assessment
timeFrame: Baseline, after 3 and after 8 weeks
measure: Change in isokinetic muscle force
timeFrame: Baseline, after 3 and after 8 weeks
Secondary outcomes:
measure: Change in functional physical ability 1
timeFrame: Baseline, after 3 and after 8 weeks
measure: Change in functional physical ability 2
timeFrame: Baseline, after 3 and after 8 weeks
measure: Change in functional physical ability 3
timeFrame: Baseline, after 3 and after 8 weeks
measure: Change in functional physical ability 4
timeFrame: Baseline, after 3 and after 8 weeks
measure: Change in cognitive ability 1
timeFrame: Baseline, after 3 and after 8 weeks
measure: Change in cognitive ability 2
timeFrame: Baseline, after 3 and after 8 weeks
measure: Change in the quality of life
timeFrame: Baseline, after 3 and after 8 weeks
measure: Change in depressive symptoms
timeFrame: Baseline, after 3 and after 8 weeks
Other outcomes:
Locations:
city: Poznań
country: Poland
facility: Poznan University of Medical Sciences
Study officials:
affiliation: Poznan University of Medical Sciences
name: Katarzyna Hojan, MD, PhD
role: STUDY_CHAIR
References:
citation: Zasadzka E, Tobis S, Trzmiel T, Marchewka R, Kozak D, Roksela A, Pieczynska A, Hojan K. Application of an EMG-Rehabilitation Robot in Patients with Post-Coronavirus Fatigue Syndrome (COVID-19)-A Feasibility Study. Int J Environ Res Public Health. 2022 Aug 20;19(16):10398. doi: 10.3390/ijerph191610398.
Clinical trial NCT00233636: Iressa and Radiotherapy in the Treatment of the Locally Advanced Inoperable Squamous Cell Carcinoma of the Head and Neck
Official title: A 2 Part Phase 2 Trial to Evaluate ZD1839 (Iressa™) & Radiotherapy in Patients w/Locally Advanced Inoperable Squamous Cell Carcinoma of the Head & Neck
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Head and Neck Cancer
Carcinoma, Squamous Cell
Keywords: Squamous Cell Carcinoma of Head and Neck
Inoperable locally advanced Squamous Cell Carcinoma of Head and Neck
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-10-06
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the study is to determine if Iressa added to radiotherapy is effective and safe in shrinking tumour dimensions.


Eligibility criteria: Inclusion Criteria:

* Histologically Confirmed locally advanced Squamous Cell Carcinoma of Head and neck
* At least one measurable tumour lesion

Exclusion Criteria:

* No previous treatment such as chemotherapy, radiotherapy and/or surgery for Carcinoma Head and Neck
* No other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
* Any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease)

Primary outcomes:
measure: Tumour Response Rate, as complete response (CR) and partial response (PR) . Six months after Last Patient In.
Secondary outcomes:
measure: Time to progression, Overall survival, Duration of response. Six months after Last Patient In.
Other outcomes:
Locations:
city: Aviano
country: Italy
facility: Research Site
city: Azienda
country: Italy
facility: Research Site
city: Milano
country: Italy
facility: Research Site
city: Napoli
country: Italy
facility: Research Site
city: Palermo
country: Italy
facility: Research Site
city: Ragusa
country: Italy
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Italy Medical Director, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04263636: Luminous Efficiency Function V(λ)' of Patients That Underwent Pseudophakic Presbyopic Corrections
Official title: Introduction of a Modified Luminous Efficiency Function V(λ)' That Addresses Total Light Transmittance of Patients That Underwent Pseudophakic Presbyopic Corrections
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Presbyopia
Keywords: pseudophakic presbyopic correction
trifocal intraocular lens
light intensity
eye light transmittance
light efficiency function
Lead sponsor: Democritus University of Thrace
Sponsor class: OTHER
First posted: 2020-02-11
Enrollment: 100
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Presbyopic patients that underwent pseudophakic presbyopic correction with bilateral trifocal intraocular lenses implantation

Brief summary: Primary objective of this study is to construct and validate a modified luminous efficiency function that addresses the distinct total eye light transmittance of patients that underwent bilateral pseudophakic presbyopic correction with trifocal intraocular lenses (IOLs) implantations.

Detailed description: Present study aims to identify in which degree multifocal IOLs modify eye light transmission and estimate the necessary task and environmental lighting adjustment in order to address lighting needs of patients following bilateral pseudophakic presbyopic corrections. Specifically, the aim of this study is to identify the minimum light intensity in which patients that underwent pseudophakic presbyopic correction with trifocal IOLs can reach their maximum visual acuity (measured when lights are at the 100% lighting level)

Eligibility criteria: Inclusion Criteria:

* age between 45 to 70 years

Exclusion Criteria:

* astigmatism \>1.00 diopters
* glaucoma
* former incisional eye surgery
* corneal or fundus disease
* diabetes mellitus
* autoimmune diseases
* neurological or psychiatric diseases
* posterior capsule rupture or lens misalignment
* postoperative uncorrected bilateral distant visual acuity \< 8/10.

Primary outcomes:
measure: Minimum light intensity
timeFrame: 6 months postoperatively
Secondary outcomes:
measure: Critical Visual Acuity (CVA)
timeFrame: 6 months postoperatively
Other outcomes:
Locations:
city: Alexandroupolis
country: Greece
facility: University Hospital of Alexandroupolis
state: Evros
Study officials:
affiliation: Associate Professor
name: Georgios Labiris, MD, PhD
role: STUDY_CHAIR
References:
citation: Labiris G, Panagiotopoulou EK, Taliantzis S, Perente A, Delibasis K, Doulos LT. Lighting Standards Revisited: Introduction of a Mathematical Model for the Assessment of the Impact of Illuminance on Visual Acuity. Clin Ophthalmol. 2021 Nov 28;15:4553-4564. doi: 10.2147/OPTH.S326139. eCollection 2021.
Clinical trial NCT06406036: A Validity and Reliability Study for Urdu Version of Rivermead Mobility Index in Stroke Patients
Official title: Reliability and Validity of Rivermead Mobility Index in Urdu Language Among Pakistani Stroke Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: Rivermead Mobility Index
Urdu Version
Reliability
Validity
Stroke
Mobility
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-05-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Target population for this study will be diagnosed cases of stroke.

Brief summary: The aim of the study is to translate and cross-culturally adapt the Rivermead mobility index questionnaire into traditional Urdu language to investigate its psychometric properties (reliability \& validity) for those patients who are confronting stroke.

Detailed description: As per preceding commendation, Rivermead Mobility Index will be translated into Urdu language from its English version and adapted culturally in Pakistan. Among Stroke population, Rivermead Mobility Index will be conducted in 50 patients recruited by convenience sampling technique under the pre-defined inclusion and exclusion criteria after signing consents forms. For testing inter-observer reliability and intra-observer reliability of Rivermead Mobility Index, Barthel Index and Functional Independence Measure will be administrated by two observers, on the same day, with a time interval of 2 hours between 1st and 2nd conduction. As for the 3rd conduction, it will be carried out after seven days by the first observer, for intra-observer assessment. Statistical Package of Social Sciences software version 24 has been used for the purpose of data entry and analysis. Internal consistency will be assessed by using an intra-class correlation coefficient. The Rivermead Mobility Index will be evaluated for content validity, construct validity, criterion validity and responsiveness.

Eligibility criteria: Inclusion Criteria:

* Male and female both genders
* Adults between the ages of 18 and above
* Stroke patients ( chronic)
* Ability to provide informed consent

Exclusion Criteria:

* Any musculoskeletal pathologies
* Suffering from any cardiovascular pathologies
* Any history of fracture
* Any histories of infections
* Any history of neurological disorders
* Having any spinal deformity

Primary outcomes:
measure: Rivermead Mobility Index
timeFrame: 1st day
measure: Barthel Index
timeFrame: 1st day
measure: Functional Independence Measure
timeFrame: 1st day
Secondary outcomes:
Other outcomes:
Locations:
city: Faisalabad
country: Pakistan
facility: Ripah International University
state: Punjab
Study officials:
affiliation: Riphah International University
name: Muhammad Kashif
role: STUDY_CHAIR
References:
Clinical trial NCT02520336: Postpartum Diabetes Screening in Women With Gestational Diabetes
Official title: Active Management of Postpartum Diabetes Screening After Gestational Diabetes: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes, Gestational
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2015-08-11
Enrollment: 78
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Assess postpartum diabetes screening in GDM patients with initiation of a reminder system in the postpartum period


Eligibility criteria: Inclusion Criteria: GDM, english speaking -

Exclusion Criteria: Non english speaking. Younger than 18 years of age

-

Primary outcomes:
measure: Postpartum Diabetes screening in GDM patients
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
Study officials:
References:
Clinical trial NCT06495736: Application of Rapid On-site Evaluation in Lymph Node Biopsy of Breast Cancer
Official title: Application of Rapid On-site Evaluation in Lymph Node Biopsy of Breast Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Yunnan Cancer Hospital
Sponsor class: OTHER
First posted: 2024-07-11
Enrollment: 400
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this clinical trial is to evaluate the value of rapid on-site evaluation（ROSE） in lymph node biopsy of breast cancer. The main question it aims to answer is:The ROSE technique was applied to breast cancer lymph node biopsy to improve the diagnostic efficiency and accuracy.

Participants underwent routine lymph node biopsy, and the test personnel conducted routine disease examination and rose technique evaluation on the removed ly


Eligibility criteria: Inclusion Criteria:

* Patients had pathologically confirmed primary breast cancer
* Surgical treatment was available

Exclusion Criteria:

* Previous history of surgery on the affected axilla, internal breast or chest
* Pregnant or breastfeeding patients
* Previous radiotherapy or chemotherapy
* Complicated history of other tumors

Primary outcomes:
measure: The number of positive and negative lymph nodes diagnosed by ROSE technique
timeFrame: up to 2 years
Secondary outcomes:
measure: The time taken to diagnose using the ROSE technique
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Kunming
country: China
facility: Yunnan Cancer Hospital
state: Yunnan
Study officials:
References:
Clinical trial NCT02925936: Choice of Tube Extremity in Emission of Lowest Radiation Dose in Pediatric Patients
Official title: Choice of Tube Extremity in Emission of Lowest Radiation Dose in Pediatric Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Radiation Absorption
Radiography
Keywords: Radiography
Radiation
Diagnostic imaging
Lead sponsor: Instituto de Cardiologia do Rio Grande do Sul
Sponsor class: OTHER
First posted: 2016-10-06
Enrollment: 48
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Compare the radiation in pediatric patients thyroid submitted to chest X-ray using the position of the anode and cathode.

Detailed description: The study's primary goal was to compare radiation exposure in two different positions during chest x rays in children. It was conducted from June/2014 to July/2015, and included children from 0 to12 years old staying at the Pediatric Intensive Care Unit at the Instituto de Cardiologia de Porto Alegre, Brazil, with chest x ray requests during ICU stay. They were randomized to two groups: during the x ray, one group was positioned with the thyroid facing the anode end, and the other group was positioned with the thyroid facing the cathode end.

Eligibility criteria: Inclusion Criteria:

* Younger than 12 years old
* Admitted to the Paediatric ICU at Instituto de Cardiologia de Porto Alegre
* Chest X ray requested by treating physician

Exclusion Criteria:

* Patients with scans that failed to comply with the technical criteria from the European Community Commission guidelines on quality criteria for diagnostic radiographic images in paediatrics, as evaluated by the radiologist doctors responsible for that exam report.

Primary outcomes:
measure: Dose of radiation used in thyroid gland with Ionization chamber
timeFrame: One month
Secondary outcomes:
measure: Dose of radiation used in thorax with spectrometer
timeFrame: One month
measure: Dose of radiation used in gonads with tape to measure
timeFrame: One month
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Instituto de Cardiologia do Rio Grande do Sul
state: RS
Study officials:
affiliation: Instituto de Cardiologia do Rio Grande do Sul
name: Silvia Goldmeier, Dr
role: STUDY_CHAIR
References:
citation: Rodrigues GO, Medeiros RF, Rodrigues SC, Boll LFC, Irigoyen MC, Goldmeier S. Choice of tube extremity for emission of the lowest radiation dose in pediatric patients. Int J Cardiol Heart Vasc. 2018 Oct 10;21:64-68. doi: 10.1016/j.ijcha.2018.06.006. eCollection 2018 Dec.
Clinical trial NCT04773236: Evaluation of Buffered Local Anesthesia in Dental Extraction.
Official title: Evaluation of Buffered Local Anesthesia in Dental Extraction: A Randomized Clinical Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Anesthesia, Local
Lead sponsor: University of Baghdad
Sponsor class: OTHER
First posted: 2021-02-26
Enrollment: 100
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: SUPPORTIVE_CARE

Brief summary: To compare pain during injection, onset of anesthesia and effectiveness of anesthesia using buffered versus non- buffered 2% lidocaine with 1:80,000 adrenaline in dental extraction.

Detailed description: The investigators will conduct a prospective, randomized, single-blinded study, the sample will include 100 patients (extraction) who need dental extraction of upper teeth (premolar and molar teeth). The predictor variable is the use of buffered 2% lidocaine with 1:80,000 adrenaline and non-buffered 2% lidocaine with 1:80,000 adrenaline. The patients will be randomly assigned into two groups of 50 patients each using Microsoft Excel 2016; the first group (study group) will undergo dental extraction after receiving buffered 2% lidocaine with 1:80,000 adrenaline, the second group (control group) will undergo dental extraction after receiving non-buffered 2% lidocaine with 1:80,000 adrenaline. The outcome variables include pain during injection, onset of anesthesia and effectiveness of anesthesia on buffered and non-buffered group.

Eligibility criteria: Inclusion Criteria:

1. Give written, informed consent (both the subject and the legal guardian).
2. Be 18-65 years of age. 3.Be able to comprehend the visual analog scale (instructions given to ascertain this).

4.Be able to comprehend the verbal rating scale (instructions given to ascertain this).

5.upper premolars and molars extraction.

Exclusion Criteria:

1. Patient under 18 years.
2. pregnant women.
3. patient with uncontrolled systemic disease that are contraindicated for dental extraction. 4- patient taking medication that interfere with the assessment of local anesthetic such as narcotics and antidepressants .

Primary outcomes:
measure: Pain during Injection
timeFrame: Immediately after Injection
measure: Onset of anesthesia
timeFrame: 30 seconds to 90 seconds
measure: Effectiveness of anesthesia
timeFrame: during procedure
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: