louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02016027: Pharmacological Effect of Carica Papaya Leaves Mother Tincture in Healthy Individuals Blood Parameter
Official title: Pharmacological Effect of Carica Folia Mother Tincture in Healthy Individual's Blood Parameter.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Dengue
Lead sponsor: Fr Muller Homoeopathic Medical College
Sponsor class: OTHER
First posted: 2013-12-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: AIMS \& OBJECTIVES To evaluate the effectiveness of administering of Carica folia mother tincture to healthy individual's Platelet count.

Sample Details:- Students, Doctors and non-teaching staffs of Father Muller Homoeopathic Medical College are taken up for the study. A minimum of 60 persons will be selected and will be divided into two groups, Control \& Experiment by lottery method.

Voluntary participation in the study is expected. 30 persons in each group. One group will receive Carica folia mother tincture and other group will receive placebo.

Complete Blood count including platelet count will be measured for all 60 subjects before commencing the study.

The drug namely Carica Folia mother tincture will be procured from Father Muller Homoeopathic Pharmaceutical Division which compiles with the standards of Homoeopathic Pharmacopeia of India.

Daily dosage -30 drops of Carica Folia mother tincture in 30 ml of distilled water morning and night for 3days.

On 4th day complete blood count including platelet count will be estimated for all 60 subjects.

Research Methodology and Statistics:

Pre \&Post with Control Design is done. Data from the sample is collected and is subjected to Paired 't' test and unpaired 't' test.

HYPOTHESIS:-

Null hypothesis:

No significant changes in complete blood count and platelet count before and after the intervention.

Alternate hypothesis:

There is significant variation in complete blood count and platelet count before and the intervention.


Eligibility criteria: Inclusion Criteria:

* healthy individuals
* Age group- 18yrs to 25yrs
* both sexes
* free from any type of medicinal agent at least 15 days before commence the intervention.

Exclusion Criteria:

* person suffering from any illnesses
* age group below 18yrs and above 25yrs.
* person taking any medicinal agents, vitamins or any kinds of supplements will not be considered as subject.

Primary outcomes:
measure: Increase in platelet count
timeFrame: 3 days
Secondary outcomes:
measure: Increase in Red Blood Cell count
timeFrame: 3 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04395027: Iatrogenic Atrial Septal Defect Study (iASD)
Official title: Iatrogenic Atrial Septal Defect Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Septal Defect, Atrial
Keywords: mitral valve intervention
iatrogenic septal defect
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2020-05-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is an open-label, randomized, controlled trial of iatrogenic atrial septal defect closure with the an atrial septal occluder versus usual care observation in patients post-mitral valve intervention requiring large bore transspetal access.

Detailed description: This study is an open label, prospective, multicenter, non-randomized single-arm study to evaluate the safety and efficacy of the closing iatrogenic atrial septal defects in patients undergoing transcatheter mitral valve procedures using large sheaths.

A maximum of 5 Clinical Sites (referred to as "Sites" in the remainder of this document) in the U.S. Two hundred and ten patients will be enrolled in this study. The patients will randomized 1:2 device: control. The anticipated accrual rate is approximately 20 Subjects per month for a total accrual period of approximately 12-18 months.

Patients may be enrolled into the study provided all inclusion and no exclusion criteria are met as specified in Section 4. Subjects will be evaluated through hospital discharge and return for follow-up visits at 30 days, 6 months, and 12 months.

Eligibility criteria: Inclusion Criteria:

1. Age ≥18 at the time of informed consent signature.
2. Capable of complying with Protocol requirements, including follow-up.
3. An Informed Consent Form signed by Subject or legal representative.
4. Patient has had successful reduction of mitral regurgitation to at most moderate regurgitation post-mitral-clip.

Exclusion Criteria:

1. Remaining mitral regurgitation of ≥ moderate-severe
2. Subject unable or unwilling to provide informed consent
3. Concomitant severe aortic valve disease
4. Dialysis
5. Pregnancy or intent to become pregnant
6. Life expectancy \< 1 year
7. Active bleeding
8. Inability to follow up with 6-month timepoint due logistical concerns

Primary outcomes:
measure: survival
timeFrame: 6 month
Secondary outcomes:
measure: survival
timeFrame: 1 year
measure: Freedom from heart failure hospitalization
timeFrame: 1 year
measure: NYHA Functional Class
timeFrame: 1 year
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Marvin Eng
state: Michigan
Study officials:
affiliation: Henry Ford Hospital
name: Marvin Eng, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05693727: Cancer Ratio,Pleural Fluid Adenosine Deaminase,Lactate Dehydrogenase, interferonY, Tumor Necrosis Factor,and Interleukins{2,12,18}for Differentiation Between Malignant and Non Malignant Pleural Effusion
Official title: Cancer Ratio,Pleural Fluid Adenosine Deaminase,Lactate Dehydrogenase, interferonY, Tumor Necrosis Factor,and Interleukins{2,12,18}for Differentiation Between Malignant and Non Malignant Pleural Effusion
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Pleural Effusion, Malignant
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-01-23
Enrollment: 100
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: patients with exudative pleural effusion who will be admitted to Department of Chest diseases and Tuberculosis, Assiut University Hospital

Brief summary: To evaluate the ability of cancer ratio and pleural fluid markers to discriminate between malignant and non malignant effusion

Detailed description: Pleural effusion is a common clinical entity affecting approximately 1.5 million patients per year in the United States. {3.1}A large number of diseases may be associated with pleural effusion.

This includes:

* Local conditions affecting the pleura (eg, tuberculous pleurisy, pleural mesothelioma),
* Extrapulmonary diseases with secondary pleural involvement (eg, chronic heart failure, liver cirrhosis).

To date, differentiation between both types of pleural effusion (exudate and transudate) is the most common initial diagnostic approach for patients with pleural effusion.

Exudative effusion is commonly seen in three conditions namely cancer (MPE), tuberculosis (TB) and para pneumonic Although MPE can be diagnosed by simple pleural fluid cytology, this method has significant limitations, including a highly variable sensitivity, ranging from as low as 11.6% to as high as 71%.

In contrast to other common causes of pleural effusion such as T.B, no accurate biomarkers of MPE have been established.

Several tumor markers were extensively evaluated, including carcinoembryonic antigen, cytokeratin-19 fragments, and cancer antigen 125, but none of them were found sensitive and specific enough to be implemented in routine clinical practice

Eligibility criteria: Inclusion Criteria:

* Patients (100 cases) with exudative pleural effusion who will be admitted to Department of Chest diseases and Tuberculosis, Assiut University Hospital

Exclusion Criteria:

* Age ˂ 18 years
* Refusal to participate in the study

Primary outcomes:
measure: Differentiate between malignant and non malignant pleural effusion by pleural markers
timeFrame: Baseline
Secondary outcomes:
measure: Time saving
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT07011927: Extra-cochlear Electrode Placement at the Post-auricular Vagus Nerve in Cochlear Implantation
Official title: Single-center Non-inferiority Study of Extra-cochlear Electrode Placement at the Post-auricular Vagus Nerve in Cochlear Implantation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hearing Loss
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2025-06-10
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study will evaluate hearing outcomes after cochlear implantation with placement of the ECE1 ground electrode near the post-auricular vagus nerve (Arnold's nerve) to assess non-inferiority with respect to placement under the temporalis muscle.


Eligibility criteria: Inclusion Criteria:

* will be undergoing surgery for a cochlear implant from Cochlear Americas
* is willing to participate in the study

Exclusion Criteria:

* has history of prior ear surgery, congenital ear malformation, or prior cochlear implantation in the ear to be implanted
* pregnant, planning to become pregnant, or breastfeeding patients cannot undergo the standard-of-care implantation procedures required for participation in the study.

Primary outcomes:
measure: AzBio Sentence Recognition Test Score
timeFrame: Up to Year 1 post cochlear implant activation
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: J. Thomas Roland, Jr., MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01477827: Sunlight Exposure and Vitamin D in Children
Official title: Sunlight Exposure and Vitamin D Status of Children in the UK
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Schoolchildren
Lead sponsor: University of Manchester
Sponsor class: OTHER
First posted: 2011-11-23
Enrollment: 125
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Schoolchildren in Greater Manchester

Brief summary: The purpose of this study is to examine the amount of sunlight exposure and vitamin D status of adolescent schoolchildren in each season throughout the year.


Eligibility criteria: Inclusion Criteria:

* Healthy school children aged 12-15 years
* White Caucasian
* Male or female

Exclusion Criteria:

* History of photosensitivity disorder

Primary outcomes:
measure: Serum concentration of 25-hydroxyvitamin D
timeFrame: Approximately every 3 months
Secondary outcomes:
measure: Amount of sunlight exposure received
timeFrame: Approx every 3 months
measure: Dietary intake of vitamin D
timeFrame: Approximately every 3 months
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Salford Royal NHS Foundation Trust
Study officials:
affiliation: University of Manchester
name: Lesley Rhodes, MBBS MD FRCP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02690727: To Evaluate the Food Effect on Relative Bioavailability of RP6530 in Healthy Volunteers
Official title: An Open Label, Randomized, Single Dose, Cross Over Study to Evaluate Food Effects on Relative Bioavailability of RP6530 Administered in Fasting and Fed Conditions in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Fasting
Fed condition
Pharmacokinetics
Lead sponsor: Rhizen Pharmaceuticals SA
Sponsor class: INDUSTRY
First posted: 2016-02-24
Enrollment: 18
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a single centre, open label, randomized, two-treatment, two-period, two-sequence, single dose crossover food effect study in 18 subjects. The subjects will receive the study medication under either fed or fast during each treatment period.

Detailed description: The present study will be conducted in healthy male volunteers. A single oral dose will be administered to the subject in each treatment period (under either fasting or fed state). Each treatment period will be separated by at least 7 calendar days. Post dose PK blood samples will be collected in each treatment period to evaluate the food effect on bioavailability of RP6530. The safety and tolerability of single dose will also be evaluated.

Eligibility criteria: Inclusion Criteria:

* Healthy male volunteers; aged 18 to 45 years;
* Body mass index (BMI) between 18.0 and 30.0 kg/m2 inclusive, weight ≥ 50 kg;
* Non- smokers or ex-smokers;
* Able to give informed consent.

Exclusion Criteria:

* Subjects with evidence or history of clinically significant disease;
* Positive results to HIV Ag/Ab Combo, Hepatitis B surface Antigen (HBsAG (B) (hepatitis B)) or Hepatitis C Virus (HCV (C)) tests;
* Subjects who have received any investigational drug in the previous 28 days;
* Subjects participated in a study with PI3k inhibitors at least once in past year;
* Subjects who have received drugs metabolised by CYP3A4 enzyme in the previous 28 days.

Primary outcomes:
measure: Pharmacokinetic Parameters (Area Under the Plasma Concentration Versus Time Curve (AUC))
timeFrame: up to 24 hours post-dose.
Secondary outcomes:
measure: Number of Participants Who Were Evaluated for Adverse Events
timeFrame: 7 days
measure: Pharmacokinetic Parameters
timeFrame: up to 24 hours post-dose.
Other outcomes:
Locations:
city: Quebec
country: Canada
facility: Algorithme Pharma Inc
Study officials:
affiliation: Algorithme Pharma Inc
name: Eric Sicard, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04983927: Evaluation of Clinical Decision Support System for Scoring of ASPECT Score Using Brain CT Images
Official title: An Open Label, Single-center, Retrospective, Pivotal Study to Evaluate the Efficacy of Clinical Decision Support System for Scoring of ASPECT Score Using Brain CT Images
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemic Stroke
Lead sponsor: Heuron Inc.
Sponsor class: INDUSTRY
First posted: 2021-07-30
Enrollment: 326
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: (1) Adults over 19 years old (2) Brain CT acquired are confirmed to be enrolled

Brief summary: cASPECTS is a software that has been pre-learned based on ASPECTS Score of ischemic stroke patients using brain CT images, and clinical decision support system for scoring ASPECTS score by automatically analyzing brain CT images by assisting the medical team.

The specific aims of this study are to evaluate efficacy of cASPECTS for scoring ASPECTS Score compared to the sensitivity and specificity levels of human expert.


Eligibility criteria: Inclusion Criteria:

* Adults over 19 years old
* Brain CT acquired

Exclusion Criteria:

* Patients with ischemic stroke in posterior circulation
* Poor or incomplete brain CT image quality

Primary outcomes:
measure: Differences between ASPECTS scores in golden standard and in cASPECTS
timeFrame: Within 4 weeks after collecting data
Secondary outcomes:
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
state: Namdong-gu
Study officials:
affiliation: Gachon University Gil Medical Center
name: Daehan Choi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01936727: Comparison of Two Phacoemulsification-methods: EasyTip 2.2mm vs. Infusion Assisted EasyTip 2.2mm
Official title: Comparison of Two Phacoemulsification-methods: EasyTip 2.2mm vs. Infusion Assisted EasyTip 2.2mm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataracts
Keywords: efficiency and safety
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2013-09-06
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The aim of this study was to compare the intraoperative efficiency, safety and postoperative outcomes of cataract surgery with two different "high-fluidic" settings.


Eligibility criteria: Inclusion Criteria:

* bilateral age-related cataract
* good overall physical constitution
* LOCS 2-5

Exclusion Criteria:

* previous intraocular surgery or ocular trauma
* previous corneal pathology
* previous endothelial cell count \<1200
* glaucoma
* uveitis
* PEX
* diabetic retinopathy and any other severe retinal pathology that would make a postoperative visual acuity of 20/40 (decimal equivalent = 0.5) or better unlikely
* intraocular complication like posterior capsular
* postoperative comlpications (e.g. postoperative uveitis)

Primary outcomes:
measure: phacoemulsification time
timeFrame: intraoperative
measure: effective phacoemulsification time
timeFrame: intraoperativ
measure: fluid volume
timeFrame: intraoperativ
Secondary outcomes:
measure: postoperative corneal oedema
timeFrame: 1 day, 1 week, 6 months
measure: postoperative endotheial cell loss
timeFrame: 6 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Ophthalmology and Optometry of the Medical University Vienna
Study officials:
affiliation: Medical University of Vienna
name: Rupert Menapace, Ao.Univ.-Prof. Dr.med.univ.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05978427: Efficacy and Safety of Superior Trunk Block Versus Interscalene Block for Post-operative Analgesia in Shoulder Surgeries
Official title: Efficacy and Safety of Superior Trunk Block Versus Interscalene Block for Post-operative Analgesia in Shoulder Surgeries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Superior Trunk Block Versus Interscalene Block for Post-operative Analgesia in Shoulder Surgeries
Keywords: superior trunk block
interscalene block
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-08-07
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Efficacy and safety of superior trunk block versus interscalene block for post-operative analgesia in shoulder surgeries

Detailed description: The interscalene brachial plexus block is the gold standard analgesic technique for surgery involving the shoulder and upper arm. However, due to its complications as hemidiaphragmatic paralysis, the superior trunk block was developed in an attempt to reduce major complications.The utility of the superior trunk block has yet to be studied in shoulder surgeries.

Eligibility criteria: Inclusion Criteria:

* Patients American Society of Anaesthesiologists physical status (ASA) is I to II.
* Both genders.
* Aged group from 21 to 50 years old.
* Patients electively scheduled for shoulder surgery under general anesthesia with normal coagulation profile.

Exclusion Criteria:

* Refusal of the procedure or participation in the study.
* Any history or evidence of coagulopathy.
* Evidence of infection at injection site.
* Allergy to study drugs.
* Patients with pulmonary severe respiratory disease.
* Herniated cervical disc or cervical myelopathy.
* Pre-existing neuropathy of the operative limb

Primary outcomes:
measure: diaphragmatic paralysis postoperative
timeFrame: within 24 hours after surgery
Secondary outcomes:
measure: analgesic efficacy
timeFrame: within 24 hours after surgery
measure: rescue analgesia
timeFrame: within 24 hours after surgery
measure: Post operative nausea and vomiting
timeFrame: within 24 hours after surgery
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ainshams University
Study officials:
References:
Clinical trial NCT03689127: Heated Breathing Circuit on Postoperative Sore Throat After Double-lumen Endobronchial Tube Insertion
Official title: Influence of Heated Breathing Circuit on Postoperative Sore Throat in Patients Undergoing Double-lumen Endobronchial Tube Insertion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Surgery
Keywords: intubation
pharyngitis
Lead sponsor: Keimyung University Dongsan Medical Center
Sponsor class: OTHER
First posted: 2018-09-28
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This investigation is planned to compare the incidence and severity of postoperative sore throat according to the use of heated breathing circuit in patients undergoing double-lumen endotracheal intubation.


Eligibility criteria: Inclusion Criteria:

* ASA I-III
* Patients scheduled for double-lumen endotracheal intubation

Exclusion Criteria:

* Difficult airway
* Mallampatti scores greater than 2
* Recent sore throat
* Cervical spine disease
* Recent upper respiratory infection
* Recent analgesics
* History of head and neck surgery
* Friable teeth
* Multiple intubation attempts

Primary outcomes:
measure: Number of participants with postoperative sore throat for postoperative 24 h
timeFrame: At 24 hours
Secondary outcomes:
measure: Number of participants with postoperative sore throat
timeFrame: At 1, 6, and 24 hours
measure: Postoperative sore throat scores
timeFrame: At 1, 6, and 24 hours
measure: Number of participants with postoperative hoarseness
timeFrame: At 1, 6, and 24 hours
measure: Number of participants with postoperative shivering
timeFrame: At 1, 6, and 24 hours
measure: Wound pain scores
timeFrame: At 1, 6, and 24 hours
measure: Jaw discomfort scores
timeFrame: At 1, 6, and 24 hours
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Hyun-Chang Kim
state: Non-US/Canada
Study officials:
References: