louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04754451: The Effect of Lidocaine Patch for Postoperative Pain
Official title: The Efficacy and Safety of 5% Lidocaine Patch for Postoperative Pain in Unilateral Inguinal Herniorrhaphy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Pain
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
Collaborators: name: SK Chemicals Co., Ltd.
First posted: 2021-02-15
Enrollment: 32
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The lidocaine patch is currently only permitted for post herpetic neuralgia but the investigators want to study its effectiveness in post operative pain after inguinal herniorrhaphy

Detailed description: After open unilateral inguinal herniorrhaphy, patients are randomly divided into group L and group P groups. Group L attaches two lidocaine patches for 12 hours, above and below the incision site. Group P attaches two placebo patches for 12 hours, above and below the incision site. Pain scores are recorded for 30 minutes, 2 hours, 24 hours, and 1 week after surgery.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists physical status I - II
* Scheduled open unilateral herniorrhaphy

Exclusion Criteria:

* body mass index (BMI) \< 18.5 or ≥ 35 kg/m2
* severe renal or hepatic dysfunction
* allergy to amide-based local anesthetic agents
* taking class 1 antiarrhythmic drugs (tocainide and mexiletine, etc.)

Primary outcomes:
measure: The pain score
timeFrame: 24 hours after the anesthesia finished.
Secondary outcomes:
measure: The pain score
timeFrame: 30 min after the anesthesia finished.
measure: The pain score
timeFrame: 2 hours after the anesthesia finished.
measure: Total amount of cumulative analgesics
timeFrame: 24 hours after the anesthesia finished.
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National Universuty, Bundang Hospital
state: Gyonggido
Study officials:
affiliation: Seoul National University Bundang Hospital
name: BON WOOK KOO
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ahn HM, Oh HK, Kim DW, Kang SB, Koo BW, Lee PB. Efficacy and safety of 5% lidocaine patches for postoperative pain management in patients undergoing unilateral inguinal hernia repair: study protocol for a prospective, double-blind, randomized, controlled clinical trial. Trials. 2022 Sep 11;23(1):767. doi: 10.1186/s13063-022-06700-3.
Clinical trial NCT02561351: Correlation Between Fractional Exhaled Nitric Oxide (FeNO) Levels and Asthma Exacerbation
Official title: Correlation Between Fractional Exhaled Nitric Oxide (FeNO) Levels and Asthma Exacerbation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bronchial Asthma
Keywords: bronchial asthma
fractional exhaled nitric oxide (FeNO)
asthma exacerbation
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2015-09-28
Enrollment: 70
Sex: ALL
Minimum age (years): 7
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: atopic asthmatic patients in Department of Pediatrics, Siriraj hospital (tertiary care)

Brief summary: The purpose of this study is to determine mean or median of fractional exhaled nitric oxide (FeNO) in Thai atopic asthmatic children that divided into subgroups due to asthma exacerbation according to the global initiative for asthma guideline.

Detailed description: From many previous studies, fractional exhaled nitric oxide (FeNO) has many benefits such as non-invasive, easily to perform, less time consume, has direct association with severity of inflammation of bronchial trees and sputum eosinophils, has benefit for diagnosis and monitoring the treatment in asthmatic patients.

In Thailand, this field of study is less extend, especially in children population. The investigators hypothesized that patients with asthma exacerbation may have high level of fractional exhaled nitric oxide (FeNO) than non exacerbation group.

It is therefore desirable to examine the association between fractional exhaled nitric oxide (FeNO) and asthma exacerbation among atopic asthmatic Thai children and will be the main objective of this research.

Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of atopic bronchial asthma follow up in clinic of allergy and clinical immunology, Siriraj hospital

Exclusion Criteria:

* smoker or past history of smoking
* chronic disease eg. HIV infection, pulmonary hypertension, systemic lupus erythematosus, liver cirrhosis, gastroesophageal reflux, COPD, bronchiectasis
* drink ethanol within 48 hours before enrollment
* history of upper or lower respiratory tract infection within 6 weeks before enrollment drink caffeine within day before enrollment during pregnancy history of systemic steroid use within 8 weeks before enrollment

Primary outcomes:
measure: Occurrence of asthma exacerbation in the studied cases with different FeNO levels
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02740751: Efficacy of Herbal Galactogogues in Breastfeeding Mothers
Official title: Efficacy of Herbal Galactogogues on Weight Gain of the Newborns Within the First Month of Life in Breastfeeding Mothers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Weight Gain
Lead sponsor: Dr. Sami Ulus Children's Hospital
Sponsor class: OTHER
First posted: 2016-04-15
Enrollment: 90
Sex: ALL
Minimum age (years): 3
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Herbal teas with galactogoge effects have been used extensively in recent years in order to increase the amount of breast milk in lactating mothers. We also investigated whether a sleep-induced herbal tea (Still-Tee; Mamsel®) was effective in regulating the sleep of these mothers. Plain water was used as placebo.

Detailed description: Herbal teas with galactogoge effects have been used extensively in recent years in order to increase the amount of breast milk in lactating mothers. Mothers of premature babies often have problems in breastfeeding and this study was designed to investigate if such herbal teas has any effect on the increasing of breast milk in mothers of premature babies. We also investigated whether a sleep-induced herbal tea (Still-Tee; Mamsel®) was effective in regulating the sleep of these mothers. Plain water was used as placebo.

Eligibility criteria: Inclusion Criteria:

* Babies with gestational age of 35-42 weeks
* Breasfed babies
* Lactating mothers
* Babies admitted to outpatient clinics of neonatology within the the first week of life

Exclusion Criteria:

* Babies with gestational age of \<35 weeks
* Not breast feeding mothers
* Babies admitted to outpatient clinics of neonatology within the the first week of life

Primary outcomes:
measure: Weight gain
timeFrame: 4 weeks
Secondary outcomes:
measure: Breast milk volume
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Dr Sami Ulus Children Hospital
Study officials:
affiliation: Dr Sami Ulus Research and Training Hospital
name: Dilek Dilli, Assoc Prof
role: STUDY_DIRECTOR
References:
citation: Foong SC, Tan ML, Foong WC, Marasco LA, Ho JJ, Ong JH. Oral galactagogues (natural therapies or drugs) for increasing breast milk production in mothers of non-hospitalised term infants. Cochrane Database Syst Rev. 2020 May 18;5(5):CD011505. doi: 10.1002/14651858.CD011505.pub2.
Clinical trial NCT06142851: Management of Women With Superficial Dyspareunia
Official title: Management of Women With Superficial Dyspareunia
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Superficial Dyspareunia
Keywords: superficial dyspareunia
management
Lead sponsor: Université de Reims Champagne-Ardenne
Sponsor class: OTHER
First posted: 2023-11-22
Enrollment: 2000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with superficial dyspareunia

Brief summary: Superficial dyspareunia are persistent or recurrent pains during an attempt at sexual intercourse or during effective penetration.

They affect between 3 to 18% of women and are a source of physical and psychological suffering.

Some health professionals (gynecologists, general practitioners, midwives) are confronted daily with these complaints.

The approach of sexuality remains a complex subject even within the medical field. As a result, communication between women and health professionals can be difficult, leading to delayed diagnosis or inadequate management.

Detailed description: The main objective is to describe the management of superficial dyspareunia by health professionals.

Eligibility criteria: Inclusion Criteria:

* Aged 18 or over
* Superficial dyspareunia, i.e.:

  * Having already had several painful vaginal penetrative sex
  * Having pain at the intromission (at the beginning of the vagina and at the level of the vulva) and/or at the beginning of penetration (by a penis, fingers, sextoys)
  * Having persistent and/or recurrent pain (appearing in a manner regular)
* Agreeing to participate in the study

Exclusion Criteria:

* Minors
* Protected by law (guardianship, curatorship, safeguarding of justice)
* Refusing to participate in the study

Primary outcomes:
measure: medical history
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Ufr Medecine Urca
city: Reims
country: France
facility: Université de Reims Champagne Ardenne
Study officials:
References:
Clinical trial NCT06694051: Application of Phototherapeutic Keratectomy Mode to Mark the Axis of Astigmatism
Official title: Application of Phototherapeutic Keratectomy Mode to Mark the Axis of Astigmatism
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Astigmatism
Lead sponsor: Tianjin Eye Hospital
Sponsor class: OTHER
First posted: 2024-11-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Corneal refractive surgery is an effective way to correct refractive error. Modern corneal refractive surgery for the correction of myopia or hyperopia can achieve or close to the expected goal, but to eliminate astigmatism is always one of the major problems of corneal refractive surgery. The key point in the correction of astigmatism is that as a vector parameter, astigmatism has both magnitude and direction. The angle error may be caused by the rotation of the patient's head position and the involuntary rotation of eyes. Phototherapeutic keratectomy can precisely cut the corneal tissue, and is often used in clinic to remove corneal scars or repair corneal surface morphology. In this study, the excimer laser therapeutic keratectomy mode was used to achieve accurate marking of the axis of astigmatism by setting the treatment laser parameters. With the help of the static cyclotorsion of the eye, the precise treatment of astigmatism could realize.


Eligibility criteria: Inclusion Criteria:

* at least 18 years old

Exclusion Criteria:

* ocular disease

Primary outcomes:
measure: refraction
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Eye Hospital
state: Tianjin
Study officials:
References:
Clinical trial NCT03332251: Trial of Posture Correction Girdle for Adolescents With Early Scoliosis
Official title: Anisotropic Textile Braces for Adolescent Idiopathic Scoliosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Scoliosis
Keywords: Posture Correction Girdle
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2017-11-06
Enrollment: 15
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Adolescent idiopathic scoliosis (AIS) is a prevalent chronic condition that gradually leads to the three dimensional deformity of the spine. Spine curvature increases in youths as puberty progresses. Generally, only observation is suggested for adolescents with early scoliosis (Cobb's angle ≤ 20°). Rigid brace treatment is too draconian for them due to the high corrective force which nearly constrains all movements. Flexible brace treatment is an alternative option; however, its efficacy is still controversial. Posture correction girdle with a specialized design for teenagers with scoliosis is limited and most part of them can only provide some improvement for bad postures, such as hunchback. A scientific approach should be used to design and develop posture correction girdle as a treatment option for adolescents with early scoliosis.

Detailed description: The design of posture correction girdle will incorporate different mechanisms, such as

1. compression and pulling forces through a close fit of the intimate apparel
2. lumbar flexion by using a supporting belt
3. transverse forces applied by inserting pads inside the pocket lining by using the principle of the 3-point pressure system
4. axial rotation or coupled motion by using a system with uneven straps, and
5. an active mechanism that aims to shift the trunk away from areas of pressure.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of AIS
* Cobb's angle 10˚-20˚
* Risser grade ≤ 2
* No prior treatment
* Pre-menarche or post- menarche by no more than 1 year
* Ability to read and understand English or Chinese
* Physical and mental ability to adhere to anisotropic textile braces protocol

Exclusion Criteria:

* Diagnosis of other musculoskeletal or developmental illness that might be responsible for the spinal curvature
* History of previous surgical or orthotic treatment for AIS
* Contraindications for pulmonary and/ or exercise tests
* Psychiatric disorders
* Recent trauma
* Recent traumatic (emotional) event

Primary outcomes:
measure: Effectiveness of posture correction girdle
timeFrame: 6 months
Secondary outcomes:
measure: Posture improvement
timeFrame: 6 months
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: The Hong Kong Polytechnic University
Study officials:
References:
Clinical trial NCT05836051: Testing the Effect of ENDS Flavors on Neurotransmission
Official title: Testing the Effect of ENDS Flavors on Neurotransmission
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tobacco Dependence
Keywords: Tobacco
Nicotine
Smoking
Addiction
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2023-05-01
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The overarching goal of this translational proposal is to determine if neuroactive flavor chemicals can enhance the addiction potential of electronic nicotine delivery systems (ENDS) by altering brain function and behavior.

Detailed description: For this randomized double-blind controlled trial, tobacco users will be randomized to use ENDS with an e-liquid containing a neuroactive flavor (hexyl acetate) vs. an inactive flavor (ethyl acetate) for ten days as a supplement to their typical tobacco use. Laboratory measures of ENDS reinforcement, subjective ENDS ratings, and brain reactivity to the flavor using functional magnetic resonance imaging (fMRI) will be collected at baseline and after ten days of ENDS use.

Eligibility criteria: Inclusion Criteria:

1. 21 to 60 years old
2. Regular users of inhaled tobacco products (≥5 days out of the last 28)
3. Not planning to quit tobacco use within next month
4. Able to read and write in English

Exclusion Criteria:

1. Major neurological conditions or brain trauma
2. Current substance use impairing participation
3. Unstable or significant medical conditions (e.g., COPD, coronary heart disease)
4. Current use of smoking cessation medication (e.g., varenicline, patch)
5. Uncontrolled serious mental illness, suicidality, or inpatient psychiatric hospitalization in the past 6 months
6. Known allergic reaction to ENDS liquids ingredients propylene glycol or vegetable glycerin
7. Unable to use study provided ENDS ad-libitum for at least 3 hours per day
8. Pregnant or breastfeeding as indicated by self-report or urine pregnancy screen

MRI-specific exclusion criteria:

1. MRI safety contraindications (e.g., metal implants, claustrophobia)
2. Major neurological conditions or brain trauma

Primary outcomes:
measure: Brain reward reactivity
timeFrame: Pre to post-intervention (approximately 10 days)
measure: Absolute reinforcement
timeFrame: Pre to post-intervention (approximately 10 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Health
state: Pennsylvania
Study officials:
References:
Clinical trial NCT00186251: High Dose Chemotherapy Followed By PBSC Rescue for HD
Official title: Use of High Dose Chemotherapy Followed by Peripheral Blood Stem Cell Rescue for Relapsed or Resistant Hodgkin's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hodgkin Disease
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 200
Sex: ALL
Minimum age (years): 4
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the role of high dose chemotherapy with autologous hematopoietic cell transplantation in the treatment of Hodgkin's Disease.

Detailed description: Use of High Dose Chemotherapy Followed by Peripheral Blood Stem Cell Rescue for Relapsed or Resistant Hodgkin's Disease

Eligibility criteria: Inclusion Criteria:- adequate organ function

* recurrent HD Exclusion Criteria:- CNS disease
* no prior malignancy

Primary outcomes:
measure: Overall survival
measure: FFS
measure: Response rates
Secondary outcomes:
measure: Toxicity of high dose chemotherapy
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Sally Arai
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04768751: Acute Kidney Injury as a Risk Factor for Myocardial Injury and Ventricular Dysfunction
Official title: Assessment of Acute Kidney Injury as a Risk Factor for Myocardial Injury and Ventricular Systolic Dysfunction After Non-Cardiac Surgery in Critical Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
Ventricular Dysfunction
Myocardium; Injury
Lead sponsor: South Egypt Cancer Institute
Sponsor class: OTHER
First posted: 2021-02-24
Enrollment: 520
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with normal kidney functions and free normal heart functions

Brief summary: Acute kidney injury (AKI) is classically described as an abrupt or rapidly reversible reduction in the excretion of nitrogenous waste products, including urea, nitrogen and creatinine. Acute kidney injury definition emphasizes on the filtration function of the kidney, a measure that is unique and easily and routinely measured .

Acute kidney injury is associated with significantly increased resource utilization and health care costs.

Major adverse cardiac events (MACE) after non cardiac surgery are a leading cause of morbidity and mortality. The reported incidence of postoperative myocardial infarction (POMI) among patients undergoing non cardiac surgery is between 3% and 6%.


Eligibility criteria: Inclusion Criteria:

* Patients with normal kidney functions and free normal heart functions, were enrolled to this study

Exclusion Criteria:

* patients with chronic kidney disease, cardiac disease, who with minor operations, or emergency, were excluded from the study.

Primary outcomes:
measure: development myocardial injury
timeFrame: through study completion, an average of 15 days
Secondary outcomes:
Other outcomes:
Locations:
city: Assuit
country: Egypt
facility: Alaa Ali Elzohry
Study officials:
References:
Clinical trial NCT00909051: GlucoVIP - Diabetes Treatment by Glucobay® With a Special Therapeutic View to Chosen Patient Groups
Official title: Diabetes Treatment by Glucobay® With a Special Therapeutic View to Chosen Patient Groups
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Keywords: Diabetes Mellitus
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-05-27
Enrollment: 15729
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 untreated or pretreated diabetes mellitus type 2
* No Glucobay® intake within the last 3 months before documentation of initial visit
* Exclusion Criteria: contraindication stated in the local Glucobay® product information; warnings and precautions must be considered.

Brief summary: Evaluation of safety and effectiveness of Glucobay® under daily-life treatment conditions in a large sample of patients.


Eligibility criteria: Inclusion Criteria:

* Patients with untreated or pretreated diabetes mellitus or patients for which acarbose is indicated and without acarbose treatment within the last three months before study inclusion. The decision for treatment type and duration is taken by the investigator and is made before inclusion into the study.

Exclusion Criteria:

* Exclusion criteria must be read in conjunction with the local product information.

Primary outcomes:
measure: Data collection on patients weight and waist circumference, fasting blood glucose, postprandial blood glucose (2h), HbA1C; exploratory analysis according to patient groups (concomitant cardiovascular disease groups, BMI)
timeFrame: During observation period of three months
Secondary outcomes:
Other outcomes:
Locations:
city: Multiple Locations
country: Algeria
city: Multiple Locations
country: Bosnia and Herzegovina
city: Multiple Locations
country: Cambodia
city: Multiple Locations
country: China
city: Multiple Locations
country: Hong Kong
city: Multiple Locations
country: India
city: Multiple Locations
country: Indonesia
city: Multiple Locations
country: Korea, Republic of
city: Multiple Locations
country: Malaysia
city: Multiple Locations
country: Moldova, Republic of
city: Multiple Locations
country: Pakistan
city: Multiple Locations
country: Philippines
city: Multiple Locations
country: Russian Federation
city: Multiple Locations
country: Singapore
city: Multiple Locations
country: Thailand
city: Multiple Locations
country: Vietnam
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Zhang W, Kim D, Philip E, Miyan Z, Barykina I, Schmidt B, Stein H; Gluco VIP study. A multinational, observational study to investigate the efficacy, safety and tolerability of acarbose as add-on or monotherapy in a range of patients: the Gluco VIP study. Clin Drug Investig. 2013 Apr;33(4):263-74. doi: 10.1007/s40261-013-0063-3.