louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03178747: Tzanck Smear With Methylene Blue Stain for Herpes
Official title: A Comparative Study of Tzanck Smear With Methylene Blue Versus Giemsa Stain to Diagnose Herpes Simplex, Herpes Zoster and Varicella Zoster Skin Infections
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Herpes Simplex
Herpes Zoster
Varicella Zoster
Keywords: Methylene blue
Giemsa
Tzanck smear
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
Collaborators: name: Dermatological Society of Thailand
First posted: 2017-06-07
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: To compare the sensitivity of Tzanck smear with methylene blue stain versus traditional Giemsa stain in patients with herpes infection.

Detailed description: A smear from the lesional skin of the patients suspected having Herpes simplex, Herpes zoster and Varicella zoster skin infections will be collected (in a clinical routine setting). The specimen will be stained with methylene blue in addition to the Giemsa stain. Polymerase chain reaction study for herpes antigen will be performed in some of the specimens. The sensitivity, specificity, positive predictive value and negative predictive value will be calculated from the results of the study.

Eligibility criteria: Inclusion Criteria:

* patients with clinically suspected of having herpes simplex, herpes zoster, varicella zoster skin infections.
* Those who have vesicular skin lesion such as acute eczema, Paederus dermatitis.
* Those are well cooperative.
* Age \> 18 years old.

Exclusion Criteria:

* Those who are not willing to have specimen from skin lesions to be collected.

Primary outcomes:
measure: Sensitivity
timeFrame: 24 weeks
Secondary outcomes:
measure: Factors that contribute the results from Methylene blue staining
timeFrame: 24 weeks
measure: Specificity
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Division of Dermatology, Faculty of Medicine, Chulalongkorn University
Study officials:
affiliation: Chulalongkorn University
name: Pawinee Rerknimitr, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04299347: Influence of the Restorative Cervical Margin Placement on the Supracrestal Tissue Attachment
Official title: Influence of the Restorative Cervical Margin Placement on the Supracrestal Tissue Attachment. A Longitudinal Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gingivitis
Keywords: subgingival restorations
proximal restorations
cytokine
biomarkers
GCF sampling
Lead sponsor: University of Siena
Sponsor class: OTHER
First posted: 2020-03-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients coming to the Endodontic and Restorative department of Policlinico le Scotte- Siena, when eligible, were included in the study.

Brief summary: The aim of the present study is to understand the influence that marginal/subgingival restorations exert on the surrounding periodontal tissues. Even though proximal restorations are routine in everyday clinical practice, few information is available as to whether or not they may have a detrimental effect on the supracrestal tissue attachment.


Eligibility criteria: Inclusion Criteria:

* an age range 18-70 years
* a good general health
* the ability to understand the phases of the trial and to stick to them for the whole length of the study
* the ability of will to release a written informed consent
* presence of a marginal cavity or a 2mm subgingival cavity
* presence of a cavity subgingival \> 2mm

Exclusion Criteria:

* PPD\>4mm
* patients affected by active periodontal disease
* patients smoking more than 10 cigarettes/pipes per day

Primary outcomes:
measure: Bleeding on Probing
timeFrame: 12 months
Secondary outcomes:
measure: radiographic distance from the caries/margin of the restoration to the bone crest
timeFrame: 12 months
Other outcomes:
Locations:
city: Siena
country: Italy
facility: AOUS
Study officials:
References:
Clinical trial NCT05055947: Efficacy Biomarker Investigation on Extensive Stage Small Cell Lung Cancer
Official title: Efficacy Biomarker Investigation on Extensive Stage Small Cell Lung Cancer Who Treated With Atezolizumab Plus Etoposide and Platinum Based Chemotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Extensive Stage Small Cell Lung Cancer
Lead sponsor: Hunan Province Tumor Hospital
Sponsor class: OTHER
First posted: 2021-09-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Extensive Stage Small Cell Lung Cancer who Treated with Atezolizumab plus Etoposide and Platinum Based Chemotherapy

Brief summary: The purpose of the trial is to find some biomarkers to predict the efficacy of Atezolizumab plus etoposide and platinum based chemotherapy as the first line treatment in extensive stage small cell lung cancer. Mainly observe the patient's progression free survival time after treatment.


Eligibility criteria: Inclusion Criteria:

* 18， Extensive Stage Small Cell Lung Cancer Confirmed by Histopathology Treated with Atezolizumab plus Etoposide and Platinum Based Chemotherapy

Exclusion Criteria:

- Patients with contraindication of chemotherapy Pregnant or breast feeding women

Primary outcomes:
measure: PFS
timeFrame: April 2019- July 2021
measure: OS
timeFrame: April 2019- July 2021
Secondary outcomes:
Other outcomes:
Locations:
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
Study officials:
affiliation: Hunan Cancer Hospital
name: Yongchang Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02528747: A Survey of Breast Cancer Patients With Metastatic Bone Disease Receiving Oral Ibandronate
Official title: A Multi-Center Observational Survey of Breast Cancer Patients With Metastatic Bone Disease Receiving Oral Ibandronate (BONDORAL)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-08-19
Enrollment: 582
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: Breast cancer patients with metastatic bone disease who are receiving oral ibandronate will be followed for approximately 1 year.

Brief summary: This observational, multicenter survey is designed to assess the efficacy of oral ibandronate in adults with breast cancer and metastatic bone disease. Data on the use of ibandronate in clinical practice will be collected from Hungarian patients.


Eligibility criteria: Inclusion Criteria:

* Adults at least 18 years of age
* Histologically confirmed breast cancer with bone metastasis
* Receiving or indicated for the tablet formulation of ibandronate according to the summary of product characteristics (SmPC) and local labeling

Exclusion Criteria:

* Contraindication to ibandronate according to SmPC
* Ongoing participation in any trial evaluating the efficacy and/or safety of ibandronate

Primary outcomes:
measure: Change in bone pain according to Visual Analog Scale (VAS) score
timeFrame: From Baseline to the end of 1 year
Secondary outcomes:
measure: Compliance with tablet formulation of ibandronate according to Case Report Form (CRF) questionnaire
timeFrame: Up to approximately 1 year
measure: Incidence of adverse events
timeFrame: Up to approximately 1 year
Other outcomes:
Locations:
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Debrecen
country: Hungary
city: Debrecen
country: Hungary
city: Gyor
country: Hungary
city: Gyula
country: Hungary
city: Kaposvar
country: Hungary
city: Kecskemet
country: Hungary
city: Kistarcsa
country: Hungary
city: Miskolc
country: Hungary
city: Nyíregyháza
country: Hungary
city: Pecs
country: Hungary
city: Szeged
country: Hungary
city: Szekesfehervar
country: Hungary
city: Szekszard
country: Hungary
city: Szolnok
country: Hungary
city: Szombathely
country: Hungary
city: Tatabánya
country: Hungary
city: Veszprem
country: Hungary
city: Zalaegerszeg
country: Hungary
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT06086847: Effects of Progressive Resistance Training on Physical State Energy and Fatigue During Pregnancy.
Official title: Effects of Progressive Resistance Training on Physical State Energy and Fatigue During Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Related
Keywords: Energy state
Fatigue
Pregnancy
Muscle stretching exercises
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-10-17
Enrollment: 28
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the effects of progressive resistance training on physical state energy and fatigue during pregnancy. This study was a randomized controlled trial used to find the effects of progressive resistance training on physical state energy and fatigue during pregnancy. The data was collected from Sheikh Zaid Hospital via Visual analogue scale-fatigue, Numeric pain rating scale and Short form health survey-36. Sample size of 30 females was taken in 15 each group.

Detailed description: According to the findings of a study on physical activity during pregnancy in 2021, obese women, who exercise less than ladies of normal body weight may gain from gradually increasing their amount of exercise to reduce the amount of weight gain associated with pregnancy. Exercise during pregnancy was consistently associated positively with sob-R among the women in both categories, which denotes that it may have an impact on the control of lepton activity and pregnancy-induced insulin resistance. Overall, our research suggests that obese women, who are lepton-resistant and at pregnant women at high risk of gestational diabetes, fast weight gain, and increased fetal adiposity should receive advice and supportive services to raise their activity level, with an emphasis on the fact that even slight improvements in action can be good for both child and maternal health.

Eligibility criteria: Inclusion Criteria:

* Female with age of 20 to 40 years
* Between 20-25 weeks of gestation.
* Healthy individual
* Pregnant females who are easily fatigued during activities of daily living.

Exclusion Criteria:

* • Those who reported regular resistance training exercises

  * Complicated pregnancy
  * Low pre-pregnancy body weight
  * Anemia
  * Diabetes
  * Psychiatric disorder
  * Orthopedic and cardiovascular limitation

Primary outcomes:
measure: Short Form Health survey (SF-36)
timeFrame: 9 WEEKS
measure: Numeric Pain Rating Scale(NPRS)
timeFrame: 9 WEEKS
measure: Visual Analogue Scale-Fatigue(VAS-F)
timeFrame: 9 WEEKS
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Family Health Hospital
state: Punjab
Study officials:
affiliation: Riphah International University, Senior Lecturer
name: Faiza Taufiq, PPDPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02550847: Evaluation of Prognosis With Integrated MRI/PET in Patients With Pancreatic Cancer
Official title: Evaluation of Prognosis With Integrated MRI/PET in Patients With Pancreatic Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pancreatic Cancer
Keywords: MR/PET
pancreatic cancer
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2015-09-16
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will include 100 consecutive patients (around 100 newly diagnosed patients per year at NTUH) presenting with suspect pancreatic cancer for treatment.

Brief summary: The aim of this study was to evaluate MR/PET with both functional and molecular imaging on the prediction of prognosis in patients with suspected pancreatic cancer.

Detailed description: The results of MR/PET will be compared prospectively to dedicated MDCT or MR imaging, pathologic results, and clinical outcomes to assess the value of MR/PET in pancreatic cancers.

Eligibility criteria: Inclusion Criteria:

1. Diagnosed as pancreatic cancer
2. Between 20\~90 years old
3. ECOG 0-2
4. Normal renal function
5. Measurable tumor size (\>1cm)

Exclusion Criteria:

1. Contraindication for MRI exam
2. Claustrophobia
3. Renal insufficiency
4. Other malignancy
5. Pregnancy and lactating women

Primary outcomes:
measure: The tumor recurrence rate after operation at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: The overall survival after operation at 6 months
timeFrame: 6 months
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Department of Medical Imaging, National Taiwan University Hospital
name: Ting-Fang Shih, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02645747: Retrospective Data Analysis of Patients Treated for Macular Edema Due to Central Retinal Vein Occlusion
Official title: RETRO CRVO: Retrospective Data Analysis of Patients Treated for Macular Edema Due to Central Retinal Vein Occlusion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Retinal Vein Occlusion
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2016-01-05
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The source population of this study is patients who suffer from visual impairment due to macular edema secondary to central retinal vein occlusion.

Brief summary: The objective of this retrospective chart review is to evaluate drug utilization, usage patterns and indication of effectiveness Eylea in the routine clinical (real-life) management of patients who suffer from ME (Macular Edema), secondary to CRVO (Central Retinal Vein Occlusion), and who started treatment with Eylea for this indication.


Eligibility criteria: Inclusion Criteria:

* Male or female adult patients who suffer from visual impairment due to ME secondary to CRVO
* Anti-VEGF treatment-naive patients who started reimbursed Eylea treatment between the 1st of June 2014 and the 28th of February 2015

Exclusion Criteria:

* Patients diagnosed with neovascular glaucoma secondary to CRVO will be excluded.

Primary outcomes:
measure: Treatment duration
timeFrame: At 12 months of treatment with Eylea
measure: Number of eyes treated (mono-and biocular)
timeFrame: At 12 months of treatment with Eylea
measure: Change in visual acuity (BCVA score)
timeFrame: At 12 months of treatment with Eylea
measure: Number of Eylea injections per treated eye
timeFrame: At 12 months of treatment with Eylea
Secondary outcomes:
measure: Estimation of percentage (%) of eyes which need additional treatment after 2 years at the discretion of the treating physician.
timeFrame: At 12 months of treatment with Eylea
measure: Sufficiency of reimbursed number of Eylea injections (max. 9 injections/eye in year 1) for treatment of all patients during the first year of treatment.
timeFrame: At 12 months of treatment with Eylea
measure: Number of patients who discontinued their treatment with Eylea prematurely
timeFrame: At 12 months of treatment with Eylea
Other outcomes:
Locations:
city: Multiple Locations
country: Belgium
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT05570747: Simulated In-House Usability Study of Eclipse Continuous Positive Airway Pressure (CPAP) Device
Official title: Simulated In-House Usability Study of Eclipse Continuous Positive Airway Pressure (CPAP) Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: Bleep, LLC
Sponsor class: INDUSTRY
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2022-10-07
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study is designed to assess the usability of a novel CPAP human interface compared to a traditional nasal mask. Human subjects will interact with two different CPAP interfaces including a traditional CPAP mask and the 2nd generation DreamPort-Eclipse. Subjects will be requested to put on each of the different CPAP interface options a total of three times for a total of 6 trials. The order of device will be randomized.


Eligibility criteria: Inclusion Criteria:

* Male or female ≥18 years old who are impacted by obstructive sleep apnea and currently are familiar with a CPAP device.

Exclusion Criteria:

* Diagnosis of any medical or behavioral conditions that would compromise subject safety.
* Under the age of 18: target for this current version of the platform is the adult population.

Primary outcomes:
measure: Time to complete each setup
timeFrame: 1 day
measure: Number of technical issues
timeFrame: 1 day
measure: Number of times participant needs assistance
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Asheville
country: United States
facility: AeroFlow Sleep
state: North Carolina
city: Huntersville
country: United States
facility: Advanced Respiratory and Sleep Medicine
state: North Carolina
city: Murfreesboro
country: United States
facility: Sleep Centers of Middle Tennessee
state: Tennessee
Study officials:
affiliation: Bleep, LLC
name: Stuart Heatherington
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01058447: Study to Assess the Metabolism, Excretion and Pharmacokinetics of [14C]AZD1981 in Healthy Male Volunteers
Official title: An Open, Single-Dose, Single-Centre, Phase I Study to Assess the Metabolism, Excretion and Pharmacokinetics of [14C]AZD1981 in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: ADME
Healthy volunteers
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-01-28
Enrollment: 4
Sex: MALE
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is to characterize the absorption, distribution, metabolism and excretion (ADME) of a single oral dose of \[14C\]AZD1981


Eligibility criteria: Inclusion Criteria:

* Provision of signed, written and dated informed consent prior to any study specific procedure
* Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg

Exclusion Criteria:

* Exposed to radiation levels above background of \>5 mSv in the last year, \>10 mSv over the last 5 years or a cumulative total of \>1 mSv per year of life
* History or presence of any clinically significant disease or disorder in the opinion of the investigator
* Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs or ECG at baseline in the opinion of the investigator

Primary outcomes:
measure: Pharmacokinetic variables and Radioactivity
timeFrame: Frequent sampling occasions during study days
Secondary outcomes:
measure: Safety variables (ECG, adverse events, blood pressure, pulse, body temp, safety lab)
timeFrame: Frequent sampling occasions during study days
Other outcomes:
Locations:
Study officials:
affiliation: AstraZeneca R&D, Lund, Sweden
name: Eva S Pettersson
role: STUDY_DIRECTOR
affiliation: Quintiles Drug Research Unit at Guy´s Hospital, London, United Kingdom
name: Tim Mant, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05146947: Intraoperative Near Infrared Spectroscopy of Kidney for Prediction of Acute and Sub-acute Kidney Injury in Partial Nephrectomy
Official title: Intraoperative Near Infrared Spectroscopy of Kidney for Prediction of Acute and Sub-acute Kidney Injury in Partial Nephrectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Kidney Injury
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2021-12-07
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Intra-operative NIRS measurements of kidney during partial nephrectomy, after reperfusion, for monitoring ischemia and prediction of postoperative renal dysfunction.


Eligibility criteria: Inclusion Criteria:

* Candidates for partial nephrectomy at Tel Aviv Medical Center who will consent to participate.

Exclusion Criteria:

* Patients unable to give consent,
* Patients who were lost to follow up during the first 7 post-operative days.

Primary outcomes:
measure: Acute Kidney Injury
timeFrame: 7 days post operative and during 6 months post-surgery.
Secondary outcomes:
measure: Surgical complications
timeFrame: 7 days post operative
Other outcomes:
Locations:
Study officials:
affiliation: Tel Aviv Medical Center
name: Orr Goren, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05111847: Safety and Performance of Short- and Long-term Baseplates for Attaching the Marco Recorder
Official title: Safety and Performance of Short- and Long-term Baseplates for Attaching the Marco Recorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Subjects
Lead sponsor: UNEEG Medical A/S
Sponsor class: INDUSTRY
First posted: 2021-11-08
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: crossover in first part, parallel in second part
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this clinical investigation is to test the safety and performance of short- and longterm Baseplates constructed with different types of biocompatible adhesives.


Eligibility criteria: Inclusion Criteria:

* Informed consent obtained, and letter of authority signed before any study related activities
* Are at least 18 years of age and have full legal capacity
* Healthy skin behind the ear

Exclusion Criteria:

* Pregnant or breastfeeding
* Known allergic responses to the adhesives
* Treatment with corticosteroids, either as a cream in the area behind the ear or systemically (tablet or injection) within the last month
* Subject is unable or does not have the necessary assistance to properly operate the device system

Primary outcomes:
measure: Trans epidermal water loss (TEWL) to measure skin-friendliness
timeFrame: up to 35 days
Secondary outcomes:
Other outcomes:
Locations:
city: København NV
country: Denmark
facility: Dermato-Venerologisk Afdeling og Videncenter for Sårheling, Bispebjerg Hospital
Study officials:
References: