louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00886093: A Study To Evaluate Whether Food Affects The Plasma Drug Levels Of A 35 mg Single Dose Of PF-04447943 Taken Orally In Healthy Adult Participants
Official title: A Phase 1, Open Label, Randomized, Single Dose, Cross-Over Study To Evaluate The Effect Of Food On PF-04447943 Pharmacokinetics In Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: pharmacokinetics, single dose, crossover, fed vs fasted state
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-04-22
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of the study is to compare the plasma drug levels of PF-04447943 when taken as a 35 mg tablet after a high fat meal compared to when taken after fasting. Healthy adult volunteers will receive a single dose of the drug once when fasted and again when fed. The safety and tolerability of the drug will be monitored.


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects, not of child bearing potential.
* Age 18-55 inclusive
* Total body weight \>50 kg.

Exclusion Criteria:

* Evidence or history of clinical significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic diseases
* History of orthostatic blood pressure changes or orthostatic symptoms
* Greater than 7 drinks of alcohol per week for women and greater than 14 drinks per week for men
* Smoking more than 5 cigarettes per day

Primary outcomes:
measure: Pharmacokinetic endpoints include plasma PF-04447943 area under the curve (AUC), maximum plasma concentration (Cmax) and time of maximum plasma concentration (Tmax).
timeFrame: Up to 96 hours after drug administration
measure: Safety endpoints include vital signs, ECGs, clinical laboratory tests, clinical evaluations and examinations, and adverse events.
timeFrame: Up to 96 hours after drug administration
Secondary outcomes:
measure: No secondary outcomes
timeFrame: No secondary outcomes
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01315093: Role of Heparin in Poor Responders Undergoing In Vitro Fertilisation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Infertility
Keywords: In Vitro Fertilisation
poor responders
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
First posted: 2011-03-15
Enrollment: 50
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The addition of heparin increases pregnancy outcome parameters in poor responders undergoing In Vitro Fertilisation (IVF)


Eligibility criteria: Inclusion Criteria:

* poor responders (age\>40, abnormal ovarian test, \</=4 oocytes in previous cycle with conventional stimulation)
* infertility, indication for IVF
* no contraindications for heparin

Primary outcomes:
measure: no of oocytes retrieved
timeFrame: egg recovery, 2 years
Secondary outcomes:
measure: clinical pregnancy rate
timeFrame: 2 years
measure: live birth rate
timeFrame: 2 years
measure: cancellation rate
timeFrame: before ET, 2 years
measure: miscarriage rate
timeFrame: 2 years
Other outcomes:
Locations:
city: Athens
country: Greece
facility: 3rd Department of Obstetrics & Gynecology
state: Chaidari
Study officials:
References:
Clinical trial NCT03794193: The Effect of Unfavorable Histological Features on the Oncological Outcomes of Colon Cancer
Official title: The Effect of Unfavorable Histological Features on the Oncological Outcomes of Colon Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colon Cancer
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: Chinese Academy of Medical Sciences
name: West China Hospital
name: Sixth Affiliated Hospital, Sun Yat-sen University
name: Peking University First Hospital
name: Wuhan Union Hospital, China
First posted: 2019-01-04
Enrollment: 1367
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Colon cancer patients with or without unfavorable histological features

Brief summary: To explore the effect of unfavorable histological features on the clinical outcomes of patients receiving radical resection of colon cancer.


Eligibility criteria: Inclusion Criteria:

1. Age: 18-100 years old;
2. Postoperative pathology confirmed colon adenocarcinoma;
3. The tumor is located from the cecum to the sigmoid colon;
4. No distant organ metastasis;

Exclusion Criteria:

1. Simultaneous or metachronous multiple primary colorectal cancer;
2. History of previous malignant tumors (except for completely cured cervical carcinoma in situ or basal cell carcinoma or squamous epithelial skin cancer)
3. local excision procedure;
4. palliative resection (R2 resection);
5. pregnant or lactating women.

Primary outcomes:
measure: 3-year Disease-free Survival
timeFrame: Within 3 years after surgery
Secondary outcomes:
measure: 3-year Over-all Survival
timeFrame: Within 3 years after surgery
measure: Postoperative complication rate
timeFrame: Within 30 days after surgery
measure: Postoperative mortality rate
timeFrame: Within 30 days after surgery
measure: Local recurrence rate
timeFrame: Within 3 years after surgery
measure: Distant organ metastasis rate
timeFrame: Within 3 years after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Peking Union Medical College Hospital
name: Yi Xiao, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04615793: Effect of Pilates Exercises on Gross Motor Function and Balance
Official title: Effect of Pilates Exercises on Gross Motor Function and Balance in Children With Diplegic Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: to Determine the Effect of Pilate's Exercises on Gross Motor Function and Balance
Lead sponsor: Badr University
Sponsor class: OTHER
First posted: 2020-11-04
Enrollment: 40
Sex: ALL
Minimum age (years): 7
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: the study aimed to asses the effect of Pilate exercise on motor function and balance in diplegic children


Eligibility criteria: Inclusion Criteria:

* 7 to 9 years,
* mild spasticity of lower limb
* able to understand and follow instructions

Exclusion Criteria:

* fixed contracture
* visual or respiratory disorders,

Primary outcomes:
measure: The Pediatric Balance Scale
timeFrame: pre and after 10 week of intervention, the maximum score is 56, so increase the score indicate improvement
Secondary outcomes:
measure: Gross motor function
timeFrame: pre and after 10 week of intervension. increase the percentage indicate improvement
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Badr Univesity in Cairo (BUC)
Study officials:
References:
Clinical trial NCT01316393: Effects of Mucoprotective Product on Xerostomia
Official title: Clinical Evaluation of a Salivary Substitute and a Mucoprotective Product on Xerostomia in Head-and-neck Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Xerostomia
Keywords: xerostomia, saliva, mucoprotection, oral health
Lead sponsor: Camurus AB
Sponsor class: INDUSTRY
Collaborators: name: Liselott Lindh, Principal Investigator, Prosthetic Dentistry, Malmö University, Malmö, Sweden
First posted: 2011-03-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: In the present study with a randomized, cross-over, blind, placebo controlled design, the effects of a salivary substitute product and a new mucoprotective product with similar mechanisms of action but with different composition and characteristics will be evaluated in cancer patients suffering from xerostomia.


Eligibility criteria: Inclusion Criteria:

1. The patient must be at least 18 years of age.
2. The patient must have clinical symptoms of xerostomia (dry mouth) due to treatment of head and neck cancer
3. The patient must understand and consent in writing to the procedure.

Exclusion Criteria:

1. Do not meet the criterion for "dry mouth" regarding saliva secretion threshold values.
2. Known allergy to ingredients in the products to be used in the trial and/or allergy to soy, peanuts, citrus fruit,Yerba Santa or methyl parabene
3. Patients who are unable or unwilling to cooperate with study procedures.

Primary outcomes:
measure: OHIP questionaire health impact profile
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Department of Prosthetic Dentistry, Malmö University
Study officials:
References:
Clinical trial NCT01663493: Comparing Methods to Biopsy Pancreas Mass
Official title: Randomized Trial Comparing 2 Needles During EUS-FNA of Solid Pancreatic Masses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreas Mass Diagnosis
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2012-08-13
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study will examine whether there is any difference in number of passes needed to diagnose pancreatic masses during endoscopic ultrasound-guided biopsies using 2 different types of needles.


Eligibility criteria: Inclusion Criteria:

* adult
* pancreas mass

Exclusion Criteria:

* coagulopathy
* mass not approachable by endoscopic ultrasound biopsy

Primary outcomes:
measure: number of passes
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Linda S Lee
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00941993: Anesthetic Effect of Lidocaine/Epinephrine Solution Delivered Via Iontophoresis to External Auditory Apparatus
Official title: First in Man Evaluation of the Anesthetic Effect of Lidocaine/Epinephrine Solution Delivered Via Iontophoresis to the External Auditory Apparatus (FIM Iontophoresis Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Otitis Media
Chronic Otitis Media
Recurrent Acute Otitis Media
Lead sponsor: Integra LifeSciences Corporation
Sponsor class: INDUSTRY
Collaborators: name: Acclarent
First posted: 2009-07-20
Enrollment: 109
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is a non-randomized, multicenter, prospective, clinical study intended to evaluate the effectiveness of a method for iontophoretic delivery of a buffered lidocaine/epinephrine solution for provision of tympanic membrane anesthesia in patients who are indicated for an ear procedure requiring penetration of the tympanic membrane, including, but not limited to, myringotomy, tympanocentesis with culture or tympanostomy with tube placement.


Eligibility criteria: Inclusion Criteria:

1. Age 12 months and older
2. Both male and female patients eligible
3. Patients are indicated for procedures requiring penetration of the tympanic membrane (including, but not limited to, myringotomy, tympanocentesis with culture or tympanostomy with tube implant)

Exclusion Criteria:

1. Patients with a history of sensitivity or reaction to lidocaine, epinephrine or any hypersensitivity to local anesthetics of the amide type or any component of the drug solution
2. Markedly atrophic, retracted, atelectatic or perforated tympanic membrane
3. Otitis externa
4. Electrically sensitive patients and patients with electrically sensitive support systems (pacemakers, defibrillators, etc.)
5. Damaged or denuded skin in the auditory canal
6. Cerumen impaction resulting in a significant amount of cleaning required to visualize the tympanic membrane

Primary outcomes:
measure: Proportion of Subjects Who Achieved Anesthesia Effectiveness Per Investigator Assessment
timeFrame: Day 0
measure: Evaluate Any Adverse Effects Associated With the Iontophoresis System (Adverse Device Effects).
timeFrame: Day 0
Secondary outcomes:
measure: Patient Tolerability of Iontophoresis Procedure Will be Measured Using a Wong Baker Faces Pain Scale
timeFrame: Day 0
measure: Subject/Parent Reported Satisfaction With the In-office Procedure
timeFrame: Day 0
Other outcomes:
measure: Patient Tolerability of In-office Ear Treatment Using the Wong Baker FACES Pain Scale.
timeFrame: Day 0
Locations:
city: Spartanburg
country: United States
facility: Spartanburg ENT
state: South Carolina
Study officials:
affiliation: Spartanburg ENT
name: Henry "Fritz" Butehorn, III, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00641693: Assess the Efficacy and Safety of Rhinocort Aqua
Official title: A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel Group, Phase II Study to Assess the Efficacy and Safety of RHINOCORT AQUA (Budesonide) Nasal Spray 16mg, 32mg and 64mg Per Day Versus Placebo in Paediatric Subjects Ages 2-5 Years Old With Allergic Rhinitis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Allergic Rhinitis
Keywords: Allergic rhinitis
Paediatric
Nasal symptoms
Congestion
Rhinorrhea
Sneeze
budesonide
Rhinocort AQUA
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-03-24
Enrollment: 650
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare Rhinocort with placebo in pediatric subjects aged 2-5 years with allergic rhinitis to study effects on nasal symptoms such as sneezing, runny and stuffy noses.


Eligibility criteria: Inclusion Criteria:

* In the opinion of the investigator, is a candidate for treatment with nasal steroids based on a history of either a) inadequate control of symptoms with antihistamines, decongestants and/or immunotherapy, or b) prior successful treatment with nasal steroids.
* A documented history of allergic rhinitis and a positive response to a skin prick test at Visit 1 or within the last 12 months for allergens that must be present in the subject's environment for the duration of the study.
* At randomisation having nasal symptom scores as defined by the protocol.

Exclusion Criteria:

* Primary or secondary adrenal insufficiency
* Nasal candidiasis, rhinitis medicamentosa, acute or chronic sinusitis, influenza, upper respiratory tract infection or structural abnormalities of the nose (e.g., septal deviation, nasal polyps) symptomatic enough to cause significant nasal obstruction as judged by the investigator.
* A diagnosis of asthma requiring treatment as specifies in the protocol.

Primary outcomes:
measure: To compare Rhinocort with placebo to compare effects on nasal symptoms such as sneezing, runny and stuffy noses as assessed by caregivers.
timeFrame: At 2 weeks
Secondary outcomes:
measure: Safety assessment via adverse events and clinical measurements
timeFrame: At 1 & 2 weeks
measure: To assess efficacy of Rhinocort via the physician and caregivers assessments
timeFrame: At 2 weeks
Other outcomes:
Locations:
Study officials:
affiliation: AstraZeneca
name: Liza O'Dowd, MD
role: STUDY_DIRECTOR
affiliation: AstraZeneca
name: Bertil Andersson
role: STUDY_DIRECTOR
References:
Clinical trial NCT05302193: Non-invasive Blood Pressure Measurement Using Samsung Smartwatch
Official title: Non-invasive Blood Pressure Measurement Using Samsung Smartwatch
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
Heart Rate
Keywords: blood pressure measurement
heart rate measurement
smartwatch
Lead sponsor: Czech Technical University in Prague
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 27
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Two measuring devices are active simultaneously during measurement of blood pressure and heart rate on each participant and their functioning is compared.
Primary purpose: OTHER

Brief summary: The aim of this study is to verify the accuracy of blood pressure and heart rate measurement by Samsung smartwatches compared to a standard monitor of vital signs used in intensive care units.

Detailed description: Recently, wearables, like smartwatches, have been gaining new possibilities in monitoring biological signals and they are used for home monitoring of health conditions. Heart rate measurement is a common function of smartwatches, some smartwatch models even measure blood pressure. The study aims to compare the measurement of blood pressure and heart rate using the latest smartwatch with a vital signs monitor used in clinical practice. Blood pressure and heart rate measurements will be taken by hand from the watch and the vital signs monitor simultaneously. The agreement of the measurements of both devices will be evaluated.

Eligibility criteria: Inclusion Criteria:

* healthy volunteers

Exclusion Criteria:

* any acute illness
* pregnancy
* severe cardiovascular conditions
* severe asthma or other severe respiratory conditions
* diabetes
* hypotension or hypertension

Primary outcomes:
measure: Similarity of blood pressure measurements from two devices
timeFrame: 1 hour
measure: Similarity of heart rate measurements from two devices
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Kladno
country: Czechia
facility: Faculty of Biomedical Engineering, Czech Technical University in Prague
Study officials:
affiliation: Czech Technical University in Prague
name: Veronika Rafl Huttova, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Czech Technical University in Prague
name: Jakub Rafl, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Czech Technical University in Prague
name: Martin Rozanek, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hahnen C, Freeman CG, Haldar N, Hamati JN, Bard DM, Murali V, Merli GJ, Joseph JI, van Helmond N. Accuracy of Vital Signs Measurements by a Smartwatch and a Portable Health Device: Validation Study. JMIR Mhealth Uhealth. 2020 Feb 12;8(2):e16811. doi: 10.2196/16811.
Clinical trial NCT01113593: A Study Characterizing Pharmacodynamic Profiles in Subjects With Chronic Obstructive Pulmonary Disease
Official title: A Randomized, Multiple-Dose, Crossover Study Characterizing the Pharmacodynamic Profiles of Formoterol Fumarate Inhalation Solution and Formoterol Dry Powder Inhaler in Subjects With Stable Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD
Lead sponsor: Dey
Sponsor class: INDUSTRY
First posted: 2010-04-30
Enrollment: 45
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to characterize the pharmacodynamic profile of Formoterol Fumarate and Foradil Aerolizer


Eligibility criteria: Inclusion Criteria:

* Able to understand the requirements of the study and provide informed consent
* A Clinical diagnosis of COPD
* A current or prior history of at least 10-pack years of cigarette smoking
* women of child-bearing potential (WOCBP) must have a negative pregnancy test at the Screening Visit and agree to avoid becoming pregnant for the duration of study

Exclusion Criteria:

* A Clinical Diagnosis of Asthma
* Other significant disease than COPD
* Subjects who radiation or chemotherapy within the previous 12 months
* Subjects who had any lung resection
* QTcB greater than 0.460 seconds
* History of illegal drug abuse or alcohol abuse within the past 5 years

Primary outcomes:
measure: Forced expiratory volume at one second (FEV1) measured (in liters) by serial spirometry to compare dosing effect and characterize pharmacodynamic profile of Formoterol Fumarate and Foradil
timeFrame: 12 hours on Day 1 and Day 7 of dosing during each treatment period
Secondary outcomes:
Other outcomes:
Locations:
city: Clearwater
country: United States
state: Florida
city: Deland
country: United States
state: Florida
city: Greenville
country: United States
state: South Carolina
city: Spartanburg
country: United States
state: South Carolina
Study officials:
References: