louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02406417: Reflective Testing for Early Diagnosis of Pituitary Dysfunction
Official title: The Use of Reflex Strategies and Reflective Testing in the Clinical Chemistry Laboratory for Early Detection of Pituitary Dysfunction in Patients From Primary Care.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pituitary Dysfunction
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2015-04-02
Enrollment: 0
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Early detection and management of pituitary dysfunction reduces the morbidity that ensues as a consequence of missed or delayed diagnosis of this condition, and which may result in life-threatening events and increased mortality.

The investigators study will explore the use of reflex strategies within the laboratory in capturing suspicious pituitary function test results from Primary Care patients and following these up with appropriate reflective testing. Subsequently patients identified from these results to have a possible underlying piuitary dysfunction will have an alert sent to their family physician prompting referral to the Endocrine team for further investigation and management.


Eligibility criteria: Inclusion Criteria:

* Patients from Primary Care found to have one or more abnormal pituitary function test picked up by the laboratory information system in the Clinical Chemistry laboratory.

Exclusion Criteria:

* Patients with known pituitary dysfunction or on medication that may affect pituitary function tests.

Primary outcomes:
measure: Number of patients found to have biochemical evidence of possible pituitary dysfunction
timeFrame: One year
Secondary outcomes:
measure: Number of patients from primary outcome found to have true pituitary dysfunction
timeFrame: 6- 12 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06251817: The Wideband Acoustic Immittance Data in Thai Normal Hearing and Conductive Hearing Loss Adults
Official title: The Wideband Acoustic Immittance Data in Thai Normal Hearing and Conductive Hearing Loss Adults
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Normal Hearing
Conductive Hearing Loss, Middle Ear
Keywords: wideband acoustic immittance
Normal hearing
Thai adults
Conductive hearing loss
Absorbance
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
Collaborators: name: Prince of Songkla University
name: Chiang Mai University
First posted: 2024-02-09
Enrollment: 290
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Thai adults 18 to 59 years old who have normal hearing 245 participants and conductive hearing loss 45 participants

Brief summary: The goal of this descriptive study is to collect the wideband immittance data in Thai normal hearing and conductive hearing loss adults. The main questions it aims to answer are:

1. What is normative data of wideband acoustic immittance in Thai normal hearing adults
2. What is the wideband acoustic immittance data in Thai conductive hearing loss who have type A, AS and Ad tympanogram Participants will examine hearing tests consequently

   * pure tone audiometry
   * Tympanometry with ipsilateral acoustic reflex
   * Wideband acoustic immittance


Eligibility criteria: Inclusion Criteria:

Normal group

1. Thai adults (18-60 years old)
2. Pure-tone air-conduction thresholds ≤ 25 dB HL, measured at audiometric frequencies 250, 500, 1000, 2000, 3000, 4000, 6000 and 8000 Hz and air-bone gab \< 10 dBHL at frequencies 500, 1000, 2000 and 4000 Hz
3. Type A tympanogram with present ipsilateral acoustic reflex
4. No diagnosis of middle ear disease
5. No history of middle ear surgery
6. Normal finding in otoscopic examination

Conductive hearing loss group

1. Thai adults (18-60 years old)
2. Pure-tone air-conduction thresholds \> 25 dB HL, measured at audiometric frequencies 250, 500, 1000, 2000, 3000, 4000, 6000 and 8000 Hz and air-bone gab \> 10 dBHL at frequencies 500, 1000, 2000 and 4000 Hz at least 2 frequencies in one ear
3. Type A, As or Ad tympanogram with absent ipsilateral acoustic reflex
4. Normal finding in otoscopic examination
5. There is an appointment for exploration middle ear within 2 months

Exclusion Criteria:

1. Have previously had middle ear surgery
2. Have an earache
3. Type B or C tympanogram
4. Volunteers who do not cooperate in audiometry test or unable to do audiometry test

Primary outcomes:
measure: Normative data of wideband acoustic immittance in Thai normal hearing adults
timeFrame: 3-4 months
Secondary outcomes:
measure: The wideband acoustic immittance data in Thai adults conductive hearing loss
timeFrame: 16-18 months
Other outcomes:
Locations:
city: Khon Kaen
country: Thailand
facility: Department of otolaryngology
Study officials:
References:
Clinical trial NCT03589417: Postural Stability, Balance and Fall Risk in Patients With Obstructive Sleep Apnea
Official title: Postural Stability, Balance and Fall Risk in Patients With Obstructive Sleep Apnea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2018-07-17
Enrollment: 50
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects aged between 30-65 years who are recently diagnosed with mild, moderate or severe OSA (AHI≥5) and not receiving any treatment yet will be included in the study.

Brief summary: Obstructive sleep apnea (OSA) is a clinical condition characterized by the repetitive obstruction of the upper airway during sleep, resulting in nocturnal hypoxaemia and fragmented sleep. Fragmented sleep leads to daytime sleepiness that causes alterations in reaction times and reflexes . Postural stability is an important function of the human body. It is shown that the sleep deprivation disturbs daytime postural stability and balance. Aim of this study is to examine the influence of OSA severity and daytime sleepiness on postural stability, balance and fall risk.


Eligibility criteria: Inclusion Criteria:

* Subjects with recent diagnosis of OSA (AHI≥5)
* BMI of ≤35 kg/m2
* Being sedentary

Exclusion Criteria:

* Having OSA treatments (CPAP, oral devices, nasal surgery, tennis ball/positional therapy, diuretic),
* Having a disease that can affect balance (vestibular, neurological, orthopedic ...) performing regular exercise
* Morphological defect (facial malformation, etc.) which may cause sleep disorders
* Uncontrolled hypertension or arrhythmia
* History of smoking or alcoholism
* Orthopedic, neurological or musculoskeletal problems which impede exercising
* Pregnancy
* Uncompensated clinical conditions such as chronic obstructive pulmonary disease, interstitial lung disease, heart failure, or rheumatic and psychiatric diseases

Primary outcomes:
measure: Postural Stability Test score
timeFrame: Baseline
measure: Limits of Stability Test score
timeFrame: Baseline
measure: Fall risk Test score
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakif Universitesi, Department of Physiotherapy and Rehabilitation
state: Eyup
Study officials:
References:
citation: Yilmaz Gokmen G, Gurses HN, Zeren M, Ozyilmaz S, Kansu A, Akkoyunlu ME. Postural stability and fall risk in patients with obstructive sleep apnea: a cross-sectional study. Sleep Breath. 2021 Dec;25(4):1961-1967. doi: 10.1007/s11325-021-02322-2. Epub 2021 Feb 20.
Clinical trial NCT00946517: Impaired Family Dynamics Leads to Non Compliance in Type I Diabetes
Official title: Impaired Family Dynamics Leads to Non Compliance in Type I Diabetes
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Type 1 Diabetes
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2009-07-27
Enrollment: 20
Sex: ALL
Minimum age (years): 9
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Endocrinology clinic patients

Brief summary: This study will test the hypothesis that certain parenting styles are associated with greater non-adherence to therapy in children and teens with type 1 diabetes. To test their hypothesis, the investigators will use standardized and validated questionnaires for parents and children to determine: parenting styles (the investigators will measure parental strictness, parental attachment, and parental monitoring), parent ability to cope with stress, parent comfort with the parenting role, parent and child level of depression and parent perception of financial resources. The investigators will also measure parent and child's perception of the child's underlying temperament and parent-child conflict. The investigators will correlate these findings with both parent and child subjective measures of adherence to therapy. The investigators will also obtain objective measures of therapy adherence including: HbA1c, number of hospitalizations for diabetes ketoacidosis and number of missed outpatient appointments. These measures will be correlated with our other findings.


Eligibility criteria: Inclusion Criteria:

* Type 1 diabetics
* Aged 9 - 18 years

Exclusion Criteria:

* None

Primary outcomes:
measure: Parenting styles
timeFrame: Baseline
Secondary outcomes:
measure: Child behavior traits
timeFrame: Baseline
measure: Adherence to therapy
timeFrame: Baseline
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: The Research Institute at Nationwide Children's Hospital, The Ohio State University
name: Dana S Hardin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04125017: Atrificial Shrinkage of Blastocyst Before In Vitro Fertilization
Official title: Comparative Study Between Two Techniques for Artificial Shrinkage of Blastocysts Prior to Vitrification: LASER Pulse Versus Micro-needle Technique in Increasing Chemical, Clinical Pregnancy and Live Birth Rates After ICSI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Lead sponsor: Aljazeera Hospital
Sponsor class: OTHER
Collaborators: name: Adam International Hospital
First posted: 2019-10-14
Enrollment: 409
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: effect of using LASER pulse versus micro-needle use in the artificial shrinkage of blastocysts .
Primary purpose: SUPPORTIVE_CARE

Brief summary: Vitrification is a modern cryopreservation technique based on sudden cooling of reproductive cells to a temperature of -196 ° C in seconds that produces glass-like solidification of a solution without crystallization, but by extreme elevation in viscosity during freezing

Detailed description: Vitrification is a modern cryopreservation technique based on sudden cooling of reproductive cells to a temperature of -196 ° C in seconds that produces glass-like solidification of a solution without crystallization, but by extreme elevation in viscosity during freezing Unlike the slow freezing method, vitrification has better results in a complete elimination of ice crystal inside the cells as well as in the surrounding solution -Also, it has a significantly higher post-thawing survival rate in comparison to slow freezing method

Eligibility criteria: Inclusion Criteria:

* women with infertility from 20 to 44 years

Exclusion Criteria:

* women with age more than 44 or less than 20

Primary outcomes:
measure: The number of women who will have positive pregnancy test
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Adam
Study officials:
affiliation: Adam hospital
name: manal kamel
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kamel Mohamed M, El-Noury MAH, Amer MK, Fakhry E, Alalfy M. Comparative study between two techniques for artificial shrinkage of blastocysts prior to vitrification: LASER pulse versus micro-needle technique in increasing chemical, clinical pregnancy and live birth rates after ICSI, a randomized controlled trial. J Matern Fetal Neonatal Med. 2022 Dec;35(25):4910-4917. doi: 10.1080/14767058.2021.1873265. Epub 2021 Feb 28.
Clinical trial NCT02351817: An Explorative Randomized Controlled Investigation Evaluating Newly Developed Ostomy Products
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ileostomy
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2015-01-30
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The primary objective of the investigation is to explore the acceptance of a newly developed adhesive.


Eligibility criteria: Inclusion Criteria:

* Have given written informed consent and letter of authority
* Be at least 18 years of age and have full legal capacity
* Be able to handle the products her/himself
* Have an ileostomy with a diameter between 10 and 30 mm
* Willing to follow the product change schedule (one change per day)
* Have had their ostomy for at least three months
* Willing to use 1 piece open ostomy products during the test period
* Must be able to use a custom cut product
* Have intact skin
* Negative result of a pregnancy test for women of childbearing age

Exclusion Criteria:

* Currently receiving or have within the past 2 months received radio- and/or chemotherapy
* Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/ injection) treatment
* Is pregnant or breastfeeding.
* Is participating in other interventional clinical investigations or have previously participated in this investigation
* Have a loop ileostomy
* Known hypersensitivity towards any of the test products

Primary outcomes:
measure: Product Acceptance
timeFrame: 7 days per test period
Secondary outcomes:
Other outcomes:
Locations:
city: Humlebaek
country: Denmark
facility: Coloplast A/S
Study officials:
affiliation: Coloplast A/S
name: Birte Petersen Jakobsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03669224: Effect of Nano Care Gold on Marginal Integrity of Resin Composite
Official title: Marginal Integrity of Resin Composite Restoration With & Without Surface Pretreatment by Gold & Silver Nanoparticles Versus Chlorhexidine in Class II Cavities Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Caries Class Ii
Keywords: marginal adptation
marginal staining
post operative sensitivity
recurrent caries
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-09-13
Enrollment: 57
Sex: ALL
Minimum age (years): 17
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study to detect the effect of Nano Care Gold on marginal integrity of resin composite restoration

Detailed description: This study will be divided into 3 groups (control, Nano Care Gold, Chlorhexidine). Both materials will be used as a surface pre-treatment. Their effect on marginal integrity will be evaluated through evaluation of marginal adaptation, marginal staining, post-operative sensitivity. The follow up period is one year

Eligibility criteria: Inclusion Criteria:

* (1) Patients with at least two class II cavities (2) 17-50 years old (3) Males or females (4) Good or hygiene (5) Good general health (6) Cooperative patients (7) Subjects who signed the informed consent

Exclusion Criteria:

1. Patients younger than 17 years or older than 50 years old
2. Pregnant females
3. Disabilities
4. Systemic disease or severe medical complications
5. Heavy smoking
6. Lack of compliance

Primary outcomes:
measure: Marginal adaptation
timeFrame: 1 year
Secondary outcomes:
measure: Marginal staining
timeFrame: 1 year
measure: Post operative sensitivity
timeFrame: 1 year
Other outcomes:
Locations:
city: Maadi
country: Egypt
facility: Aya Abd El-Fattah Mohammed Nemtallah
state: Cairo
Study officials:
References:
Clinical trial NCT00909324: Efficacy, Tolerability, and Comfort of 0.3% Hypromellose Eyedrops in Patients Undergoing LASIK Surgery
Official title: Efficacy, Tolerability and Comfort of 0.3% Hypromellose Eyedrops in the Pre- and Post-Operative Treatment of Patients Undergoing LASIK Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dry Eye
Keywords: Post LASIK dry eye
Pre LASIK dry eye
Hypromellose
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-05-28
Enrollment: 170
Sex: ALL
Minimum age (years): 21
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to assess the tolerability and comfort of peri-operative 0.3% hypromellose eye drops in LASIK surgery patients and to assess whether pre-operative 0.3% hypromellose eye drops add to post-operative comfort in LASIK surgery patients compared to control (no pre-operative lubricant).


Eligibility criteria: Inclusion Criteria:

* Age 21 - 35
* Both sexes
* Seeking LASIK surgery at the Refractive Surgery Centre
* Meeting all established criteria for appropriateness for LASIK established by the treating center

Exclusion Criteria:

* Any corneal pathology including scars, prior herpes keratitis, prior corneal transplant
* Any immuno-compromised state including cancer, HIV infection, Hepatitis B or C, or diabetes mellitus
* Requirement for any eye-drops for any reason (eg, dry eye or conjunctivitis) within 3 months from time of enrollment
* Anticipated refusal or inability to undergo planned post-operative visits or assessment
* Failure to meet all established criteria for appropriateness for LASIK

Primary outcomes:
measure: Ocular Comfort Level From Baseline to End of Study
timeFrame: Baseline (Pre-LASIK surgery), Day 1, Day 7 and Day 30 post-LASIK surgery
Secondary outcomes:
measure: Tear Breakup Time From Baseline to End of Study
timeFrame: Baseline (Pre-LASIK surgery), Day 1, Day 7 and Day 30 post-LASIK surgery
measure: Results of Schirmer's Test From Baseline to End of Study
timeFrame: Baseline (Pre-LASIK surgery), Day 1, Day 7 and Day 30 post-LASIK surgery
Other outcomes:
Locations:
city: Delhi
country: India
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
affiliation: Novartis India Ltd.
name: Novartis India Ltd.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00602524: Bioequivalency Study of 7.5 mg Pilocarpine Tablets Under Fasting Conditions
Official title: A Single Dose, Two-Period, Two-Treatment, 2-Sequence Crossover Bioequivalency Study of 7.5 mg Pilocarpine Tablets Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Mouth
Lead sponsor: West-Ward Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2008-01-28
Enrollment: 28
Sex: ALL
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: The objective of this study was the bioequivalence of a Roxane Laboratories' Pilocarpine tablets, 7.5 mg, to SALAGEN® Tablets, 7.5 mg (MGI) under fasting conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to Pilocarpine or any comparable or similar product.

Primary outcomes:
measure: Bioequivalence
timeFrame: Baseline, Two period, Seven day washout
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: CEDRA Clinical Research, LLC
state: Texas
Study officials:
affiliation: CEDRA Clinical Research, LLC
name: Daniel V Freeland, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03146624: Evaluation of Patients Satisfaction of Attachment Retained Versus Clasp Retained Obturators in Unilateral Total Maxillectomy
Official title: Evaluation of Patients Satisfaction of Attachment Retained Versus Clasp Retained Obturators in Unilateral Total Maxillectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tumour
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-05-10
Enrollment: 14
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: OBJECTIVE to evaluate patients satisfaction of obturator with attachment versus conventional obturator in treatment of unilateral maxillectomy .

Detailed description: Fourteen patients were selected according to the following criteria : patients having sufficient number of natural teeth(class I and \\or class IV Aramany classification)not less than five teeth, intact soft palate , sufficient mouth opening , not exposed to radiotherapy or chemotherapy. Patients were divided into two equal groups, each of seven patients: patients of group I(Comparator) received a clasp retained obturator, while patients of group II(Intervention) received an attachment-retained obturator (RCT). The design of the definitive obturator for group I included double Aker's clasp on the first , second premolars and molars with alternating buccal and lingual retention, palatal plate as a major connector and a meshwork extension at the defect side. For group II, crown preparation of all the remaining abutments was done. Then, in the wax pattern, a lingual guiding plane was prepared and two OT Vertical attachments were attached mesial to the most anterior abutment and palatal to the second premolar and first molar . Construction of the splinted crowns were completed and the final impression was made with the splinted crowns in place to be picked up into the impression. After final try-in of the obturator, construction of the definitive obturator was completed with a hard resin hollowed obturator bulb, functional relining with soft silicone liner for both groups.

Evaluation included patient satisfaction (primary outcome)where Two scales were followed in this study which are"The Obturator Functioning Scale" and " The European Organization for Research and Treatment of Cancer Head and Neck 35"

Eligibility criteria: Inclusion Criteria:

1. - patients with sufficient number of natural teeth(class I and \\or class IV Aramany classification),
2. - intact soft palate, 3- the mouth opening is not less than 25 mm .

Exclusion Criteria:

1- patients are exposed to radiotherapy or chemotherapy.

Primary outcomes:
measure: patient satisfaction
timeFrame: 1 month
measure: patient satisfaction
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Mohamed Yahia Sharaf
Study officials:
References: