louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02576808: Study of Efficacy and Safety of Ginger Extract Compared With Loratadine for Treatment of Allergic Rhinitis
Official title: Comparative Study of Efficacy and Adverse Effects of Ginger Extract and Loratadine for Treatment of Allergic Rhinitis Patients (Clinical Trial Phase II)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rhinitis,Allergic
Lead sponsor: Thai Traditional Medical Knowledge Fund
Sponsor class: OTHER_GOV
Collaborators: name: Thammasat University
First posted: 2015-10-15
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Efficacy and adverse effects of Ginger extract in treating allergic rhinitis patients compared with Loratadine.The double blind randomized controlled trial study was approved by the Human Research Ethics Committee of Thammasat University NO.1.

Detailed description: The double blind randomized controlled trial study. Patients who meet the inclusion criteria and do not fall into any exclusion criteria will be randomly placed into the experimental group, who will receive ginger extract capsules, or the control group, who will receive loratadine for 42 days.

Eligibility criteria: Inclusion Criteria:

1. Patients have moderate allergic rhinitis (itching and nasal obstruction, watery nasal discharge, sneezing and congestion )with a minimum total nasal symptom score 7 point
2. These patients do not have the respiratory disease such as tuberculosis, nasal polyps.
3. These patients do not have the history of disease: heart disease, kidney disease, liver disease, epilepsy, high blood pressure and severe asthma.
4. These patients are not pregnant or breastfeeding.
5. These patients have normal BMI and vital signs.

Exclusion Criteria:

1. Those who have taken anti-coagulant and anti-platelet aggregation medications.
2. Those who get serious side effects from Loratadine and ginger allergy.
3. Communication problems especially listening and interview.

Primary outcomes:
measure: Nasal symptom
timeFrame: 42days
Secondary outcomes:
measure: Quality of Life
timeFrame: 42days
measure: Nasal patency
timeFrame: 42days
Other outcomes:
Locations:
city: Khlong Luang,
country: Thailand
facility: Thammasat University Hospital
state: Pathumthani
Study officials:
affiliation: Faculty of Medicine Thammasat University (Rangsit Campus)
name: Rodsarin Yamprasert
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yamprasert R, Chanvimalueng W, Mukkasombut N, Itharat A. Ginger extract versus Loratadine in the treatment of allergic rhinitis: a randomized controlled trial. BMC Complement Med Ther. 2020 Apr 20;20(1):119. doi: 10.1186/s12906-020-2875-z.
Clinical trial NCT01705808: Administration of Protein C Concentrates in Adult Critically Ill Septic Patients
Official title: Administration of Protein C Concentrates in Adult Critically Ill Septic Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Sepsis
Lead sponsor: Università Vita-Salute San Raffaele
Sponsor class: OTHER
First posted: 2012-10-12
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: Severe sepsis and septic shock are life threatening medical emergencies and are among the most significant challenges in critical care. Case reports and case series suggest that plasma-derived protein C concentrate may improve the outcome of patients with acquired protein C deficiency. Evidence has accumulated on the clinical relevance of the PC pathway in modulating overwhelming inflammation and preventing coagulation derangements, two key mediators of organ damage, and thus of mortality and morbidity, in sepsis. The experience collected through these studies shows that PC is safe, in that it is not associated with bleeding or severe allergic complications,and possibly useful, at least to improve the coagulation abnormalities brought about by sepsis. Unfortunately, however, all we know comes from case series or case reports or an underpowered randomized controlled study. A randomized clinical trial, adequately powered for mortality or clinically relevant outcome, is necessary to confirm PC efficacy.The aim of this study is to demonstrate that Protein C zymogen has clinically relevant implications in terms of reduction of thromboembolic events, 30 days mortality, length of intensive care and hospital stay, time on mechanical ventilation, length of ICU and hospital stay. The study will also confirm that there is no bleeding concern with the use of Protein C concentrates.The study drug will be administered in the Intensive Care Unit for 72 hours and the patients observed till ICU discharge. Telephone followup will be performed at 30 days and at one year.


Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Age \> 18 years
* At least one of the following 3 criteria:

  * venous-venous extra corporeal membrane oxygenation (ECMO) for septic adult respiratory distress syndrome (ARDS)
  * septic disseminated intravascular coagulopathy (DIC)
  * sepsis induced organ dysfunction associated with a clinical assessment of high risk of death

Exclusion Criteria:

* Previous unusual response to PC or any of their components (murine proteins and heparin)
* PC administration or inclusion in other randomized protocols in the previous 30 days
* Do not resuscitate orders
* Refractory cardiogenic shock

Primary outcomes:
measure: Composite endpoint of number of participant with mortality and/or prolonged ICU stay
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Ospedale San Raffaele di Milano, Italy
Study officials:
References:
Clinical trial NCT04339608: Max COVID19- Study
Official title: A Prospective, Longitudinal, Observational Study of Healthcare Workers and the General Population to Watch for Flu-like Symptoms in Suspicion of COVID 19
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Lead sponsor: Max Healthcare Insititute Limited
Sponsor class: OTHER
First posted: 2020-04-09
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will include all the healthcare workers of Max Super Speciality Hospital, New Delhi, India, and all males and females from the general population. One questionnaire will be filled up per household.

Brief summary: In view of the increasing cases of COVID-19 in India and the possibility of the exponential rise of the cases, this study has been designed to collect data of the healthcare workers of Max Hospital and the general population. Our objective is to identify individuals with flu-like symptoms in suspicion of COVID-19 and follow them weekly up to 8 weeks until the pandemic resolves. The data will be collected through an online questionnaire circulated via Emails or WhatsApp.

Detailed description: The primary objective of this study is to screen and identify individuals with flu-like symptoms and follow-them up weekly. In the study, baseline data will be collected online and then weekly follow up will be done with the participants for 4 weeks via opted communication method. There will be no physical contact and we are also avoiding the use of papers so as to avoid possible transmission. Participation in this study will be entirely voluntary and the questionnaire will be accessible to the participants only when they mark "Agree" on the form.

The data collection form is available in English and Hindi.

The study questionnaire includes questions related to general health status, clinical symptoms, Food security, and job security.

Eligibility criteria: Inclusion Criteria:

* Indian males and females currently living in India, OR
* All the employees of Max Super Speciality Hospital, New Delhi, India

Exclusion Criteria:

* Anyone who has filled the questionnaire once per household

Primary outcomes:
measure: COVID-19 positive case
timeFrame: 4-8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Max Super Speciality Hospital, A Unit of Devki Devi Foundation
state: Delhi
Study officials:
affiliation: Max Healthcare
name: Sujeet Jha, MRCP (U.K)
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jha S, Soni A, Siddiqui S, Batra N, Goel N, Dey S, Budhiraja S, Naithani R. Prevalence of Flu-like Symptoms and COVID-19 in Healthcare Workers from India. J Assoc Physicians India. 2020 Jul;68(7):27-29.
Clinical trial NCT04831008: Comparison of Figure-Of-Eight Suture Perclose ProGlide Suture-Mediated Closure
Official title: Comparison of Figure-Of-Eight Suture and Perclose ProGlide Suture-Mediated Closure System in Achieving Hemostasis After a Large Bore Venous Access.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Venous Puncture
Keywords: Perclose Device
Figure-of-eight suture
Lead sponsor: Delray Medical Center
Sponsor class: OTHER
Collaborators: name: Florida Atlantic University
First posted: 2021-04-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The study proposes to compare specialized closure devices to achieve hemostasis with the Figure-of-eight suture technique.

Detailed description: Procedures where patients requiring large bore venous access will be randomized 1:1 to either the Figure-of-eight suture technique or the Perclose Device to achieve hemostasis.

Eligibility criteria: Inclusion Criteria:

* All patients who successfully undergo venous large bore access sheath placement for structural heart procedures.

Exclusion Criteria:

* Patients who do not consent
* Minors or those unable to consent

Primary outcomes:
measure: Hemostasis Time
timeFrame: Immediate
measure: Procedure Time
timeFrame: Immediate
measure: Access Site Complication
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Delray Beach
country: United States
facility: Delray Medical Center
state: Florida
Study officials:
affiliation: Delray Medical Center
name: Houman Khalili, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Delray Medical Center
name: Brijeshwar Maini
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00438308: Comparison of Early and Late Therapy for Adults With Operatively Treated Distal Radius Fractures
Official title: Prospective Randomized Comparison of Early and Late Wrist Mobilization After Volar Plate Fixation of a Fracture of the Distal Radius
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Distal Radius Fractures
Keywords: distal radius fracture
rehabilitation
volar plate fixation
DASH questionnaire
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2007-02-22
Enrollment: 60
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 from the MGH Hand and Upper Extremith Service

Brief summary: The purpose of the study is to compare two common ways of rehabilitating after surgery for distal radius fractures treated operatively with a volar plate.

Detailed description: Over the last three decades, operative treatment of distal radius fractures has become increasingly common compared to non-operative treatment. Over the last 15 years there has been a trend towards more invasive, internal plate fixation of fractures of the distal radius. One argument in favor of internal fixation for these fractures is that, similar to other periarticular fractures, it would be beneficial to allow early movement of the wrist articulation. There is not, however, any data to support this statement. In fact, data regarding external fixation that either immobilizes the wrist or allows wrist motion suggest that early wrist mobilization is not as important as the overall alignment of the bone in terms of final wrist motion. This question is important in patient care and in decision-making regarding these fractures. Additionally, many companies use this claim as a marketing point in spite of the lack of evidence. We consider that good quality data is needed to determine the answer to this issue and to help to resolve the related problems described above.

Eligibility criteria: Inclusion Criteria:

* Gender: Male or female
* Age: Older than 18
* Isolated distal radial fracture
* Fracture treated with volar plates, stable fixation
* Initial treatment within 4 weeks of trauma

Exclusion Criteria:

* Complex fractures that require additional or different material than volar plates
* Unstable fractures in which early mobilization is contraindicated

Primary outcomes:
measure: range of motion in degrees of the wrists
timeFrame: 6 months
Secondary outcomes:
measure: DASH score
timeFrame: 6 months
measure: Likert pain scale
timeFrame: 6 months
measure: pinch and grip strength
timeFrame: 6 months
measure: Gartland and Werely score
timeFrame: 6 months
measure: and Mayo wrist score
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Massachusetts General Hospital
name: David Ring, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05213208: Safety of Propofol Sedation ( > 200 mg) for Colonoscopy.
Official title: Propofol Sedation of More Than 200 mg Enables Patients to Drive Home After Outpatient Colonoscopy Including Colorectal Polypectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Safety Issues
Keywords: driving
propofol sedation
colonoscopy
Lead sponsor: Showa Inan General Hospital
Sponsor class: OTHER
First posted: 2022-01-28
Enrollment: 300
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: healthy subjects who drive home after colonoscopy using propofol sedation (\>200 mg)

Brief summary: This study examines that the use of \>200 mg of propofol sedation enables patients to drive home safely after outpatient colonoscopy.

Detailed description: The hospital policy of routine discharge to normal activity 1 hour after propofol mono-sedation for EGD or colonoscopy was approved by the ethics committee of Showa Inan General Hospital in January, 2004 (http://www.sihp.jp). The investigator' s subsequent experience verified the safety of this discharge policy which was reconfirmed in March 2014. Based on these studies, the upper limit of 200 mg was established for those allowed early discharge and driving to home.

This study examines that the use of \>200 mg of propofol sedation enables patients to drive home safely 90-120 minutes after outpatient colonoscopy.

Eligibility criteria: Inclusion Criteria:

* subjects who drive home by theirselves after colonoscopy using propofol sedation (\>200 mg)

Exclusion Criteria:

* Subjects who received emergency procedures
* less than 20 years old pregnant American Society of Anesthesiologists (ASA) class III or IV, overweight (body weight \>100 kg) allergic to the drugs used or its components (soybeans or eggs).

Primary outcomes:
measure: Traffic accidents
timeFrame: 1 day
Secondary outcomes:
measure: Patient satisfaction
timeFrame: 1 day
Other outcomes:
Locations:
city: Komagane
country: Japan
facility: Showa Inan General hospital
state: Nagano
Study officials:
References:
Clinical trial NCT00325208: Feeding Bottle Design, Milk Intake and Infant Growth
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy Infants
Lead sponsor: Institute of Child Health
Sponsor class: OTHER
First posted: 2006-05-12
Enrollment: 152
Sex: ALL
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It is increasingly recognised that rapid growth in infancy may be associated with a greater risk of cardiovascular disease later in life. This trial will investigate whether the use of infant feeding bottles with different designs influences the milk intake and growth of infants. We will compare the growth of bottle-fed infants with that of a breast-fed reference group.


Eligibility criteria: Inclusion Criteria:

* healthy term infants birth weight \>2.50kg, gestational age \>37 weeks

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Hillingdon hospital
city: London
country: United Kingdom
facility: Northwick Park Hospital
city: London
country: United Kingdom
facility: The Institute of Child health
Study officials:
affiliation: Institute of Child Health
name: Mary Fewtrell
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fewtrell MS, Kennedy K, Nicholl R, Khakoo A, Lucas A. Infant feeding bottle design, growth and behaviour: results from a randomised trial. BMC Res Notes. 2012 Mar 16;5:150. doi: 10.1186/1756-0500-5-150.
Clinical trial NCT02748408: The Medacta International SMS Post-Marketing Surveillance Study
Official title: The Medacta SMS Femoral Stem Component. A Multi-National, Multi-Centre, Clinical Surveillance Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Arthrosis
Traumatic Arthritis
Rheumatoid Polyarthritis
Congenital Hip Dysplasia
Avascular Necrosis of the Femoral Head
Lead sponsor: Medacta International SA
Sponsor class: INDUSTRY
First posted: 2016-04-22
Enrollment: 550
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals suitable for hip replacement using the Medacta SMS femoral stem

Brief summary: This is a Post-Marketing Surveillance of SMS femoral stem prosthesis.


Eligibility criteria: Inclusion Criteria:

* Individuals with a severely painful and/or disabling hip joint with osteoarthritis, traumatic arthritis or developmental dysplasia of the hip or avascular necrosis of the femoral head.
* In order to take part in this study, all study participants must be between the ages of 18 and 75 years of age, at the time of surgery.
* Scheduled for a primary total hip replacement.

Exclusion Criteria:

* Active infection
* Pregnancy
* Mental illness where the known condition is likely to compromise the patient's ability to consent, affect the patient's assessment of their progress or complete the 10 year cycle of follow-up appointments and reviews
* Grossly distorted anatomy (surgeon's discretion)
* Osteomalacia where uncemented implant fixation is contraindicated
* Active rheumatoid arthritis.
* Osteoporosis
* Metabolic disorders which may impair bone formation where uncemented implant fixation is contraindicated
* Muscular atrophy or neuromuscular disease
* Allergy to implant material
* Any patient who cannot or will not provide informed consent for participation in the study
* Those whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems

Primary outcomes:
measure: survivorship of the Medacta SMS femoral stem
timeFrame: 10-year
Secondary outcomes:
measure: clinical performance
timeFrame: 3, 5, 7 and 10 years
measure: radiographic performance
timeFrame: 3, 5, 7 and 10 years
measure: Evaluate the patient satisfaction
timeFrame: 6 months, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 years
measure: Evaluate the quality of life
timeFrame: 6 months, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 years
measure: pattern of bone remodeling
timeFrame: 6 weeks, 6 months, 1 year
measure: stem migration
timeFrame: 6 weeks, 6 months, 1 and 2 years
measure: Adverse events
timeFrame: up to 10 years
Other outcomes:
Locations:
city: Wien
country: Austria
facility: Herz-Jesu Krankenhaus
city: Milan
country: Italy
facility: Istituto Ortopedico Galezzi
city: Solothurn
country: Switzerland
facility: Bürgerspital Solothurn
city: Epsom
country: United Kingdom
facility: The Elective Orthopaedic Centre (EOC)
state: Surrey
Study officials:
References:
Clinical trial NCT06895408: Separate and Combined Extrapancreatic Effects of GIP and GLP-1
Official title: Separate and Combined Extrapancreatic Effects of Glucose-dependent Insulinotropic Polypeptide (GIP) and Glucagon-Like Peptide 1 (GLP-1)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pancreatectomy; Hyperglycemia
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
First posted: 2025-03-26
Enrollment: 12
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The two gut-derived hormones, glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide 1 (GLP-1) are secreted from intestinal cells in relation to a meal and increase insulin secretion from the pancreas. The hormones also exert effects outside the pancreas, but especially for GIP, these are poorly investigated. Because of this, only GLP-1 based drugs (GLP-1 receptor agonists) are on the market for the treatment of type 2 diabetes and obesity. Nonetheless, a new drug is in clinical development: a combined GIP-GLP-1-receptor agonist (tirzepatide), which has shown better results than GLP-1 alone. The mechanism behind these impressive effects are unknown and in this study, the investigators will look into the exptrapancreatic effects of GIP and GLP-1, separate and combined and thus elucidate the mechanisms of action of this new drug class.


Eligibility criteria: Inclusion Criteria:

* Total pancreatectomy
* Caucasians between 30-75 years of age
* Blood haemoglobin \>7.0 mmol/l for males and \>6.5 mmol/l for females

Exclusion Criteria:

* Pancreatectomy within the last 3 months
* Ongoing chemotherapy or chemotherapy within the last 3 months
* Treatment with GLP-1 receptor agonists within the last 3 months
* Renal impairment (estimated by estimated glomerular filtration rate (eGFR) \<60 ml/min/1.73 m2) and/or albuminuria
* Calcium related disease, hypo-/hyperthyroidism
* Known significant liver disease, plasma alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3 × normal value or INR (The international normalised ratio based on prothrombin time) outside the normal range
* Severe arteriosclerotic heart disease or heart failure (New York Heart Association (NYHA) group III or IV)
* Pregnancy and/or breastfeeding
* Use of more than 14 units of alcohol per week or abuse of narcotics
* Any condition that the investigator feels would interfere with trial participation

Primary outcomes:
measure: Plasma glucose
timeFrame: Up to two months
measure: Plasma glucagon
timeFrame: Up to two months
measure: Plasma Insulin/C-peptide
timeFrame: Up to two months
measure: Plasma triglycerides
timeFrame: Up to two months
measure: Plasma CTX
timeFrame: Up to two months
measure: Plasma PINP
timeFrame: Up to two months
Secondary outcomes:
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Center for Clinical Metabolic Research, Gentofte Hospital
Study officials:
References: