louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01146743: Prospective Trial for Endoscopic Ultrasound Guided Gallbladder Drainage for Acute Cholecystitis in High Risk Patients
Official title: Prospective Randomized Controlled Trial for Endoscopic Ultrasound Guided and Percutaneous Transhepatic Gallbladder Drainage for Acute Cholecystitis in High Risk Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cholecystitis
Keywords: EUS-guided transmural cholecystostomy
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2010-06-22
Enrollment: 59
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: The investigators would like to conduct a prospective, randomized non-inferiority study to compare clinical outcome between endoscopic ultrasound (EUS) guided gallbladder drainage and percutaneous transhepatic gallbladder drainage (PTGBD) in high risk acute cholecystitis patients.

Detailed description: The primary outcome is to compare clinical resolution rate of EUS-guided gallbladder drainage versus percutaneous transhepatic gallbladder drainage in acute cholecystitis patients with high risk.

The secondary outcome is to compare complications, conversion rate to open cholecystectomy during laparoscopic cholecystectomy.

Eligibility criteria: Inclusion Criteria:

* high risk for general anesthesia and emergency operation (American Society of Anesthesiologists, ASA grade III or IV)

Exclusion Criteria:

* Age below 18 years
* Pregnancy
* When the risks of endoscopy to patient are judged to outweigh the most favorable benefits of the procedure.
* Unstable or unwilling to comply with follow-up
* When a perforated viscus is known or suspected
* Simultaneously participating in another investigational drug or device study

Primary outcomes:
measure: Clinical response rate
timeFrame: Within 72 hours from procedure
Secondary outcomes:
measure: Complication rate
timeFrame: Complications during the procedure or within 1 weeks
measure: Conversion rate
timeFrame: During laparoscopic cholectstectomy
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: SangSoo Lee, M.D.
role: STUDY_DIRECTOR
References:
citation: Lee SS, Park DH, Hwang CY, Ahn CS, Lee TY, Seo DW, Lee SK, Kim MW. EUS-guided transmural cholecystostomy as rescue management for acute cholecystitis in elderly or high-risk patients: a prospective feasibility study. Gastrointest Endosc. 2007 Nov;66(5):1008-12. doi: 10.1016/j.gie.2007.03.1080. Epub 2007 Sep 4.
Clinical trial NCT01643343: Measurement of Joint Attention Fluency
Official title: Measurement of Joint Attention Fluency
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Autism Spectrum Disorders
Autism
Keywords: autism spectrum disorders
autism
joint attention
imitation
fluency
Lead sponsor: The Vista School
Sponsor class: OTHER
Collaborators: name: Penn State University
First posted: 2012-07-18
Enrollment: 100
Sex: ALL
Minimum age (years): 8
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample

Brief summary: The purpose of this research is to study joint attention. Joint attention plays a critical role in social and language development in children with and without autism. Joint attention is the shared attention between a child and another person. This study seeks to set a standard benchmark of frequency scores for joint attention. Finding a rate of engaging in joint attention behavior would offer a benchmark for all researchers and practitioners working with learners with and without autism.


Eligibility criteria: Inclusion Criteria:

* autism spectrum disorder

Exclusion Criteria:

* hearing or vision problems
* behaviors that are a danger to self or others

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hershey
country: United States
facility: The Vista School
state: Pennsylvania
Study officials:
References:
Clinical trial NCT04426643: Treatment of Urinary Incontinence in Men After Prostatectomy With Autologous Adipose-derived Mesenchymal Stem Cells
Official title: Treatment of Urinary Incontinence in Men After Prostatectomy With Autologous Adipose-derived Mesenchymal Stem Cells Mixed With Collagen Gel and Injected Submucousely
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Urinary Incontinence
Keywords: Urinary incontinence
Prostatectomy
Lead sponsor: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Sponsor class: OTHER_GOV
Collaborators: name: The state institution N. N. Alexandrov National Cancer Centre of Belarus
First posted: 2020-06-11
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Treatment of patients with urinary incontinence after prostatectomy using injection of autologous adipose-derived mesenchymal stem cells mixed with collagen gel

Detailed description: During the implementation of the project, it is planned to develop a method for the treatment of men urinary incontinence caused by prostatectomy using injection of autologous adipose-derived mesenchymal stem cells mixed with collagen. The positive outlook for the effectiveness of MSCs is due to the following:

* the ability of MSCs to stimulate tissue regeneration
* positive results of preclinical studies of the method of treatment of urinary incontinence in animals.

In study planing to include 5 patients. MSCs will be isolated from adipose tissue, cultured and then transplanted back to the periurethral area by five point injection in rhabdosphincter and submucosal space of urethra using the cystourethroscope. For injection in submucosal space MSCs (20\*10\^6 cells) will be mixed with collagen solution (3,5% w\|w). Follow up patients monitoring will occur at 1，3，6 and 12 months after injection.

Eligibility criteria: Inclusion Criteria:

* Urinary incontinence
* absence of acute inflammatory manifestations in the genitourinary system
* period after prostatectomy is at least 12 months

Exclusion Criteria:

* urethral or bladder malformations
* acute and chronic infectious diseases: HIV, viral hepatitis, tuberculosis
* mental disorders

Primary outcomes:
measure: Number of cured patients
timeFrame: 3 months
measure: Number of patients with treatment-related adverse events
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Minsk
country: Belarus
facility: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Study officials:
affiliation: Head of the Lab of Institute of Biophysics and Cell Engineering
name: Igor D Volotovski, Dr
role: STUDY_DIRECTOR
affiliation: Deputy Director for Research of the National Cancer Centre
name: Sergey A Krasny, Dr
role: STUDY_DIRECTOR
References:
Clinical trial NCT03191643: PET-guided External Beam Radiotherapy in Differentiated Thyroid Cancer
Official title: 18F-FDG PET-guided External Beam Radiotherapy in Iodine-refractory Differentiated Thyroid Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Differentiated Thyroid Cancer
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2017-06-19
Enrollment: 16
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: Patients with locally recurrent thyroid cancer, treated with radical external beam radiotherapy (EBRT) after total thyroidectomy +/- central compartment and/or laterocervical lymphadenectomy, previously treated with one or more cycles of 131 Iodine-ablation (RAI) and TSH suppression.

Brief summary: Description of the role of a post-operative external beam radiotherapy in patients with differentiated thyroid cancer.

Detailed description: The role of post-operative external beam radiotherapy (EBRT) in differentiated thyroid cancer is still discussed considering the low clinical aggressiveness and the availability of ablative 131Iodine therapy. However, there is a subgroup of tumors which lose the ability to capture Iodine over time. This study wants to describe the role of a post-operative external beam radiotherapy in patients with differentiated thyroid cancer.

Eligibility criteria: Inclusion Criteria:

* detectable thyroglobulin (Tg),
* negative post-metabolic radiotherapy whole body scintigraphy,
* no surgical indications.

Exclusion Criteria:

* prior radiotherapy in the head and neck area
* pregnancy

Primary outcomes:
measure: Progression free survival (PFS)
timeFrame: 6 months
Secondary outcomes:
measure: toxicities
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Radiation Oncology Center, Department of Experimental, Diagnostic and Specialty Medicine - DIMES, University of Bologna, S.Orsola-Malpighi Hospital, Bologna, Italy
name: Alessio G. Morganti, MD
role: STUDY_DIRECTOR
References:
citation: Farina E, Monari F, Castellucci P, Romani F, Repaci A, Farina A, Zanirato Rambaldi G, Frezza G, Mazzarotto R, Cammelli S, Tagliaferri L, Autorino R, Deodato F, Macchia G, Cilla S, Valentini V, Fanti S, Morganti AG. 18F-FDG Pet-Guided External Beam Radiotherapy in Iodine-Refractory Differentiated Thyroid Cancer: A Pilot Study. J Thyroid Res. 2017;2017:9807543. doi: 10.1155/2017/9807543. Epub 2017 Oct 19.
Clinical trial NCT00355043: Efficacy of Zinc in the Treatment of Bronchiolitis and Prevention of Wheezing Respiratory Illness in Children Less Than Two Years Old
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bronchiolitis
Keywords: Zinc treatment
Bronchiolitis
Wheezing
Children aged 2 months to 23 months
Diagnosed case of acute bronchiolitis
Lead sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh
Sponsor class: OTHER
Collaborators: name: United States Agency for International Development (USAID)
First posted: 2006-07-21
Enrollment: 330
Sex: ALL
Minimum age (years): 2
Maximum age (years): 23
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 1. Bronchiolitis is a leading cause of morbidity and mortality in children. It is an acute, infectious illness of the lower respiratory tract resulting in obstruction of the bronchioles. The etiology is viral in the majority of the cases and RSV is the most commonly isolated agent. The disease is more common in younger children under 2 years of age. Children often receive unnecessary antibiotics and often require hospitalization. An episode of bronchiolitis can be followed by recurrent wheezing episodes. RSV bronchiolitis in the first year of life is one of the most important risk factors for the subsequent development of asthma in both developed and developing countries. Thus, bronchiolitis is a global public health problem. Zinc supplementation has been shown to be effective in both preventing and treating pneumonia. However, no study has particularly examined the effect of zinc on ARI associated with wheezing. This study aims to investigate whether zinc (20 mg/day) reduces1. the duration of bronchiolitis in children.2. the severity of bronchiolitis in children.3. the rate of hospitalization for bronchiolitis.3. future episodes of wheezing in children.


Eligibility criteria: Inclusion Criteria:

Children 2 months to 23 months old at the time of clinical diagnosis· Episode of wheezing for the first time Written consent· Who do not require hospitalization at the time of diagnosis

Exclusion Criteria:

History of asthma Chronic cardiac or respiratory disease (e.g.cyanotic heart disease -ASD) History of previous wheezing or bronchodilator therapy Gestational age at birth \<34 weeks Suspected tuberculosis, active measles Any illness (severe malnutrition, sepsis, meningitis) that requires hospitalisation Who had zinc/placebo supplements during this study· H/o zinc intake within last 3 months· Whose caretakers withhold consent

Primary outcomes:
measure: Effect of zinc on the duration of bronchiolitis in children
Secondary outcomes:
measure: Effect of Zinc
measure: The severity of bronchiolitis.
measure: The rate of hospitalization.
measure: Future episodes of wheezing.
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: ICDDR,B
Study officials:
affiliation: International Centre for Diarrhoeal Disease Research, Bangladesh
name: Dilruba Nasrin, MBBS,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05777538: Effects of Foot Exercises and Hydrotherapy on Pedal Edema & Lower Extremity Function
Official title: Effects of Foot Exercises With and Without Hydrotherapy on Pedal Edema & Lower Extremity Function in Antenatal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Related
Keywords: foot
exercises
hydrotherapy
pedal
edema lower extremity
antenatal
women
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-03-21
Enrollment: 44
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the Effects of foot exercises with and without hydrotherapy on pedal Edema \& lower extremity function in antenatal women.


Eligibility criteria: Inclusion Criteria:

* Normal singleton pregnancy
* Gestational age 30-40 weeks
* Pitting edema in feet

Exclusion Criteria:

* presence of any under lying disease e.g.

  * Diabetes,
  * Hypertension,
  * High risk pregnancy
  * Any wound or skin lesion

Primary outcomes:
measure: Figure of 8 Method
timeFrame: 8th week
measure: Lower Extremity Functional Scale
timeFrame: 8th week
Secondary outcomes:
Other outcomes:
Locations:
city: Gujrat
country: Pakistan
facility: Sajida Khalil Hospital Gujrat
state: Punjab
Study officials:
affiliation: Riphah International University
name: Hina gul, MSOMPT
role: PRINCIPAL_INVESTIGATOR
References:
citation: .MACWAN KR, Savaliya PK. Effectiveness of Foot Exercise and Epsom Salt Water on Reduction of Foot Oedema among Antenatal Mothers. Journal of Clinical & Diagnostic Research. 2021;15
citation: Talbot L, Maclennan K. Physiology of pregnancy. Anaesthesia & Intensive Care Medicine. 2016;17(7):341-5
citation: Patola A, Tridiyawati F. The Effectiveness of Soaking the Feet in Salt Water to Reduce the Degree of Edema in Pregnant Women Trimester III. Jurnal Keperawatan Komprehensif (Comprehensive Nursing Journal). 2022;8
citation: Ahmed AH, Ismail NIAA, Hassan NMM. Effect of effleurage massage versus water immersion with exercise on physiological foot edema among primigravidae. Egypt J Health Care. 2021;12(2):56-345
Clinical trial NCT01024738: Study to Determine the Anti-plaque Efficacy of Commerical Toothpastes and an Oral Rinse
Official title: Study to Determine the Anti-plaque Efficacy of Commerical Toothpastes and an Oral Rinse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dental Plaque
Lead sponsor: Colgate Palmolive
Sponsor class: INDUSTRY
First posted: 2009-12-03
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Calibration study to determine the anit-plaque efficacy of commerical toothpastes and an oral rinse

Detailed description: Training of new examiners and validation of new clinical site to run 4 day short-term plaque studies. All products are commercially available.

Eligibility criteria: Inclusion Criteria:

* Be aged 18 to 65 years inclusive
* Have a minimum of 15 natural uncrowned teeth (excluding 3rd molars) present
* Give written informed consent
* Be in good general health
* No known history of allergy to personal care/consumer products or their ingredients, relevant to any ingredients in the test products as determined by the dental/medical professional monitoring the study
* If of childbearing potential and on birth control (Diaphragm, Birth Control Pills, Birth Control Implants, IUD (Intrauterine device), condoms)

Exclusion Criteria:

* Medical condition which requires pre-medication (antibiotics) prior to dental
* Visits/procedures
* Allergy to chlorhexidine
* Advanced periodontal disease (gum disease)
* 5 or more decayed, untreated dental sites (cavities)
* Diseases of the soft or hard oral tissues (gums or palate)
* Orthodontic appliances that interfere with plaque rating
* Abnormal salivary function
* Use of drugs that can affect currently salivary flow or production
* Use of antibiotics one (1) month prior to or during this study
* Use of any over the counter medications other than analgesics (i.e. aspirin, ibuprofen, acetaminophen,naproxyn)
* Pregnant or breastfeeding.
* Participation in another research study in the month preceding this study
* Allergic to common toothpaste or mouth rinse ingredients.
* Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy) or individuals who have a high risk of infection from other causes

Primary outcomes:
measure: Plaque Index
timeFrame: 4 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Paramus
country: United States
facility: TKL Research, Inc.
state: New Jersey
Study officials:
name: Mark LeFelt, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02890238: Sildenafil Effect After Ovulation Induction
Official title: Effect of Sildenafil Citrate on Pregnancy Rate in Women Undergoing Induction of Ovulation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Infertility
Keywords: Sildenafil Citrate
Induction of Ovulation
Pregnancy Rate
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2016-09-07
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 100 women with infertility classified into 2 groups.

Group A: Included 50 women who will be given clomiphene citrate 50mg (clomid) orally 2 times/day from 2rd-7th day of the cycle and sildeaynafil citrate 20mg tab from 7th-11th day of the same cycle orally 3 times/day.

Group B: Included 50 women who will be given clomiphene citrate 50mg (clomid) orally 2 times/day from 2rd-7th day of the cycle and placebo tablets from 7th-11th day of the same cycle orally 3 times/day.

Detailed description: 100 women with infertility classified into 2 groups.

Group A: Included 50 women who will be given clomiphene citrate 50mg (clomid) orally 2 times/day from 2rd-7th day of the cycle and sildeaynafil citrate 20mg tab from 7th-11th day of the same cycle orally 3 times/day.

Group B: Included 50 women who will be given clomiphene citrate 50mg (clomid) orally 2 times/day from 2rd-7th day of the cycle and placebo tablets from 7th-11th day of the same cycle orally 3 times/day.

Folliculometry was assessed by:

* Transvaginal ultrasound: It was done on day 11th of the cycle to detect number of follicles and endometrial thickness.

When the follicles reach ≥18 ml, injection of 5000 IU of HCG IM to trigger ovulation to both groups.

Pregnancy was assessed by:

* Beta HCG test: (Radioimmunoassay)

Eligibility criteria: Inclusion Criteria:

1. Infertile women whether it's primary or secondary infertility
2. Woman's age: (18-35 years old)
3. Menstrual cycle from (24-35 days)
4. Normal semen analysis

Exclusion Criteria:

1. Age more than 35 years old
2. Ovarian cysts
3. Abnormal hormonal profile (e.g hyperprolactinaemia)
4. Significant cardiovascular disease
5. Serious liver disease or renal failure
6. Poorly controlled diabetes mellitus

Primary outcomes:
measure: Pregnancy rate per cycle
timeFrame: 14 days after HCG triggering of ovulation
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Alainy medical school
Study officials:
affiliation: Kasr Alainy medical school
name: Ahmed Maged
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05967338: Glottis Visualization in Different Lifting Methods
Official title: Comparison of Epiglottis Lifting Methods Using a McGrath Video Laryngoscope: Direct vs. Indirect
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intubation
Glottis Visualization
Keywords: Endotrakeal intubation
Epiglottis
Glottis
McGrath MAC video laryngoscope
Lead sponsor: Zonguldak Bulent Ecevit University
Sponsor class: OTHER
First posted: 2023-08-01
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: ASA I-II, 18-65 years old patients undergoing elective surgery

Brief summary: Among the various types of video laryngoscopes, the McGrath MAC video laryngoscopy (VL) has become popular because it is lightweight and can be quickly and hygienically prepared by changing the blade. The aim of this study was to compare the efficacy of two different methods (direct and indirect) for epiglottis removal during visualization of the glottis using the McGrath MAC VL.


Eligibility criteria: Inclusion Criteria:

* ASA I-II
* general anesthesia in elective surgeries
* 18-65 years old
* body mass index (25-30)
* no risk of difficult intubation

Exclusion Criteria:

* Allergic to study drugs
* pregnant women
* emergency cases
* those with a history of difficult intubation
* those without consent
* those at risk of aspiration

Primary outcomes:
measure: POGO scores
timeFrame: 1 day (through intubation )
Secondary outcomes:
measure: Cormack-Lehane classification
timeFrame: 1 day (through intubation )
Other outcomes:
Locations:
city: Zonguldak
country: Turkey
facility: Zonguldak Bülent Ecevit University
state: Kozlu
Study officials:
References: