louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01960205: Effect of Saxagliptin on Pre-Diabetes Mellitus and Obesity
Official title: Effect of Saxagliptin on Body Fat , Glucose and Beta Cell Function in Patients With Newly Diagnosed Pre-Diabetes Mellitus and Obesity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Prediabetes
Keywords: Saxagliptin, prediabetes, glucose intolerance,obesity
Lead sponsor: Shandong Provincial Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Chinese Medical Association
First posted: 2013-10-10
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to examine the effect of Saxagliptin in the newly diagnosed people with pre-diabetes and obesity besides lifestyle intervention ,there to evaluate DPP 4 inhibitors of reversing pre-diabetes curative effect to normal blood sugar, and observe its influences on the targets of obesity related metabolic abnormalities, to explore new ways for intervention on populations with pre-diabetes and obesity .

Detailed description: Materials and Methods: This is a perspectiveness ,randomized, opening study, patients will be randomly assigned to the standarddose Saxagliptin group ,the lifestyle intervention group,the Metformin group and the low dose Saxagliptin group with a 6-month treatment period.

Oral glucose tolerance test will examined before and 6 months post-treatment during the trial.

Eligibility criteria: Inclusion Criteria:

1.Newly diagnosed insulin resistance or glucose intolerance .

2.20 to 70 years of age.

3.BMI≥28kg/m2，or BMI\>25kg/m2 beside waistline≥80cm（female)，≥90cm(male).

Exclusion Criteria:

1. Under Diabetes Mellitus treatment.
2. Allergy to dipeptidyl peptidase 4 (DPP-4) inhibitors .
3. Active heart failure.
4. Unwilling or unable to sign inform consents.

Primary outcomes:
measure: oral glucose tolerance test
timeFrame: Change of Blood sugar from baseline at 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Shandong Provincial Hospital
state: Shandong
Study officials:
affiliation: Shandong Provincial Hospital
name: Xinli Zhou, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wang Z, Xu D, Huang L, Zhang T, Wang J, Chen Q, Kong L, Zhou X. Effects of saxagliptin on glucose homeostasis and body composition of obese patients with newly diagnosed pre-diabetes. Diabetes Res Clin Pract. 2017 Aug;130:77-85. doi: 10.1016/j.diabres.2017.05.012. Epub 2017 May 12.
Clinical trial NCT00818805: Efficacy Investigation Study of Olopatadine Hydrochloride Ophthalmic Solution Using OHIO Chamber in Patients With Seasonal Allergic Rhinitis (SAR)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Allergic Conjunctivitis
Keywords: conjunctivitis
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2009-01-08
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy of olopatadine 0.1% using the OHIO Chamber in patients with seasonal allergic conjunctivitis.


Eligibility criteria: Inclusion Criteria:

1. Age/Gender: males and females aged \>20 to \< 65 years (at the time of obtaining consent).
2. Positive cases in whom blood specific IgE antibody quantification against cedar pollen showed class 2-6 in a health checkup conducted within the past 3 years.
3. Cases who were diagnosed as patients with seasonal allergic conjunctivitis and were judged eligible as subjects of the said study by the investigator or co-investigator from the results of medical examination conducted on the day of the study or prior to it.
4. Cases who gave consent on study participation of their own free will in writing, with understanding the contents of the said study.

Exclusion Criteria:

1. Cases with an ocular disease that requires treatment other than allergic conjunctivitis.
2. Cases with an inflammatory ocular disease in the external/anterior part of the eye that may affect drug efficacy evaluation.
3. Cases with a respiratory disease such as bronchial asthma other than allergic rhinitis.
4. Cases with past history of anaphylaxis.
5. Cases with past history of hypersensitivity to olopatadine hydrochloride/tranilast.
6. Cases undergoing immunotherapy (hyposensitization therapy; modulated therapy).
7. Patients who are pregnant, lactating women, or may be pregnant, or cases wishing to be pregnant during the study period.
8. Other cases who are judged ineligible for participation in the main study by the doctor in charge of the study.

Primary outcomes:
measure: Change in "Ocular Itching" Score (5-point Scale) in Subjective Symptom Questionnaire
timeFrame: 0-180 minutes after entering the examination room
Secondary outcomes:
measure: Change in Total Score in Ocular Symptom Questionnaire
timeFrame: 15-180 min.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05771805: Additional Effects of Vagus Nerve Stimulation on Motor Functions of Upper-limb in Stroke
Official title: Additional Effects of Vagus Nerve Stimulation With Task-oriented Training on Motor Functions of Upper-limb in Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke (CVA) or TIA
Keywords: Impairement
Stroke
Task oriented
Upper limb
Vagus nerve
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-03-16
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aims to determine the additional effects of vagus nerve stimulation with task-oriented training on motor functions of upper-limb in stroke

Detailed description: Stroke is a clinical syndrome characterized by rapidly developing clinical signs of focal (or global) disturbance of cerebral function lasting more than 24 hours or leading to death with no apparent cause. Nerve stimulation paired with rehabilitation is a novel potential treatment option for people with long-term moderate-to-severe arm impairment after stroke. The study aims to determine the additional effects of vagus nerve stimulation with task-oriented training on motor functions of upper-limb in stroke. The idea of stimulating the vagus nerve to modify central brain activity has been pursued. Vagus nerve stimulation (VNS) paired with rehabilitative training enhances recovery of function in models of stroke and is currently under investigation for use in chronic stroke patients. Compared to traditional stimulation, noninvasive VNS seems to be safer and more tolerable.

Eligibility criteria: Inclusion Criteria:

* Sub-Acute stroke (3 months to 6 months)
* Between grade 0 and grade 2 on modified Ashworth scale.
* Patients who will be able to walk without assisted devices and can stand for 2 minutes.
* Either type Ischemic or Hemorrhagic
* Age bracket 40-60 Years

Exclusion Criteria:

* Previous surgical intervention on vagus nerve
* Severe pain in upper extremity
* MoCA score of less than 10

Primary outcomes:
measure: Fugl Meyer Assessment Scale - Upper Extremity
timeFrame: 12 weeks
measure: Wolf Motor Function Test (WMFT)
timeFrame: 12 weeks
measure: Box and Block Test (BBT)
timeFrame: 12 weeks
measure: Nine Hole Peg Test (NHPT)
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Abbottabad
country: Pakistan
facility: Women Institute of Rehabilitation Center and Jinnah international hospital, BBH
state: KPK
Study officials:
affiliation: Riphah International University
name: Arshad Nawaz Malik, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06856005: "Assessing the Impact of Personalized Music Playlists on Procedural Anxiety and Crown Preparation Performance Among Young Dentists: A Randomized Controlled Trial"
Official title: "Assessing the Impact of Personalized Music Playlists on Procedural Anxiety and Crown Preparation Performance Among Young Dentists: A Randomized Controlled Trial"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Crown
Procedural Anxiety
Lead sponsor: Pakistan Institute of Medical Sciences
Sponsor class: OTHER_GOV
First posted: 2025-03-04
Enrollment: 64
Sex: ALL
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The objective of this study was to evaluate the effectiveness of personalized music playlists in reducing procedural anxiety among young dentists performing crown preparations for porcelain-fused-to-metal (PFM) crowns.

A randomized controlled trial with a parallel-group design was conducted at the Department of Prosthodontics, School of Dentistry, Shaheed Zulfiqar Ali Bhutto Medical University, from April 12th, 2024, to October 11th, 2024. A total of 64 young dentists (20-30 years old) were randomly assigned to two groups: the experimental group (Group A), which listened to personalized music during the procedure, and the control group (Group B), which received no music. Anxiety was measured using the State-Trait Anxiety Inventory (STAI) before and after the procedure. Physiological parameters, including heart rate and respiratory rate, were also monitored. The preparation was evaluated based on a structured scoring rubric, assessing critical parameters. The scoring was conducted by two experienced prosthodontists who were blinded to the participant's group allocation. Statistical analysis was performed using SPSS version 25.0.0, with a p-value of \<0.05 considered statistically significant.


Eligibility criteria: Inclusion Criteria:

* Both male and female
* Young dentists 20-30 years.
* Recently graduated from dental school. (graduated within the last 1-3 years.)
* No hearing impairments or known psychiatric disorders.

Exclusion Criteria:

* Dentists with previous experience in anxiety management techniques.
* Those who have already participated in similar studies.

Primary outcomes:
measure: Anxiety Assessment: trait and state anxiety.
timeFrame: 2 minutes after the procedure
measure: Crown preparation was evaluated based on a structured scoring rubric, assessing critical parameters
timeFrame: 2 minutes after the procedure
Secondary outcomes:
measure: Heart rate was recorded before and after the procedure.
timeFrame: immediately after the procedure
measure: Respiratory rate was recorded before and after the procedure.
timeFrame: immediately after the procedure
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: School of dentistry, SZABMU
state: Federal
Study officials:
References:
Clinical trial NCT01496105: Efficacy Study of Topical Application of Lidacaine Spray Prior to IUD Insertion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Drug Usage
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2011-12-21
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether the topical use of lidocaine spray 10% on the cervix is an effective way to reduce pain during IUCD insertion.


Eligibility criteria: Inclusion Criteria:

* Age 18-45
* Speak Arabic or English

Exclusion Criteria:

* History of cervical surgery
* Known hypersensitivity to topical analgesics
* First trimester abortion or miscarriage in the previous six weeks
* Second trimester abortion or miscarriage in the previous 12 weeks

Primary outcomes:
measure: VAS score of Pain
timeFrame: 5 minutes from lidocaine spraying ( after application of tenaculum)
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain shams university hospital
Study officials:
References:
Clinical trial NCT05176405: Entertainment Media to Deliver Educational Messages About Mammography in Saudi Arabia
Official title: Using Entertainment Media to Deliver Educational Messages About Mammography in Saudi Arabia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Behavior
Keywords: Mammogram
Prevention
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2022-01-04
Enrollment: 240
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: This clinical trial aims to test if Elissa's Entertainment-Education (EE) song can influence Saudi females' intention to perform breast cancer early screening via mammogram.

Detailed description: This study will be guided by a scarcely applied theoretical model that integrates the issue involvement concept into the Theory of Planned Behavior (TPB) to test the role of issue involvement in predicting intention to perform breast cancer early screening via mammogram among Saudi females after exposure to EE message.

Eligibility criteria: Inclusion Criteria:

* Saudi Arabian
* female

Exclusion Criteria:

* Females 39 or younger
* females above age 69 years
* females who have had breast cancer
* females that have had risk-reducing bilateral mastectomies

Primary outcomes:
measure: Measure the role of issue involvement in predicting intention to perform breast cancer early screening via mammogram among Saudi females after exposure to EE message.
timeFrame: 1 Day
Secondary outcomes:
measure: Measure the Theory of Planned Behavior (TPB) construct attitude, to predict Saudi females' intention to perform breast cancer early screening via mammogram
timeFrame: 1 Day
measure: Measure the TPB construct, subject norm, to predict Saudi females' intention to perform breast cancer early screening via mammogram
timeFrame: 1 day
measure: Measure the TPB construct perceived behavioral control, to predict Saudi females' intention to perform breast cancer early screening via mammogram
timeFrame: 1 day
measure: Compare the differences between EE viewers and non EE viewers in terms of issue involvement
timeFrame: 1 Day
measure: Compare the differences between EE viewers and none EE viewers in terms of attitude.
timeFrame: 1 Day
measure: Compare the differences between EE viewers and none EE viewers in terms of perceived behavioral control.
timeFrame: 1 Day
measure: Measure intention toward mammography
timeFrame: 1 Day
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Jeanine Guidry, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02218905: Normative Values and Forming Regression Equations for One Minute Sit to Stand Test in Healthy Normal Indian Population
Official title: Phase 0 Study of Reference Values for One Minute Sit to Stand Test in Healthy Indian Population - a Cross Sectional Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Human Healthy Volunteers
Keywords: Correlation
Sit to stand repetitions
Anthropometric variables
Age
Height
weight
Gender
Regression
Lead sponsor: PSG Hospitals
Sponsor class: OTHER
Collaborators: name: PSG Hospitals
First posted: 2014-08-18
Enrollment: 196
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study is to find relation between number of repetitions the volunteer able to sit and stand in an armless chair and their age, height, weight and gender. The investigators hypothesis there is a moderate relation between anthropometric characteristics and number of situps. This may partially define the ability of functional capacity and quadriceps ability.

Detailed description: Sit to stand is gaining importance as a functional capacity measurement tool in modern chronic diseases arena. Bu the reference values for normative population is not available. Hence the present study aimed at finding relation between the anthropometric variables (age, height, weight) and number of sit to stand repetitions. The volunteers will be asked to sit to stand in an arm less chair of 40 inches height. The number of repetition will be correlated and regression equations will be sought out relating number of repetitions and anthropometric variables through best fit regression equations

Eligibility criteria: Inclusion Criteria:

* Both genders
* 30 - 80 years old
* Hospital staffs, relatives of patients volunteering the test
* Willing to give consent for the test

Exclusion Criteria:

* Chronic cardiovascular and pulmonary diseases
* On anticoagulants
* Cancer undergoing chemo, radiotherapy
* recent orthopaedic ailments (Osteoarthritis, Rheumatoid arthritis, surgeries less than 3 months)
* Balance impairments

Primary outcomes:
measure: Number of repetitions of sit ups within 60 seconds
timeFrame: baseline, 1.5 minutes
Secondary outcomes:
measure: heart rate recovery (in seconds)
timeFrame: 1 minute
measure: blood pressure (mmHg)
timeFrame: baseline, 1 minute
measure: saturation (%)
timeFrame: baseline, 0.5 minute, 1 minute
measure: Heart rate (beats/ min)
timeFrame: baseline, 0.5 minute, 1 minute
Other outcomes:
measure: Anthropometric variables
timeFrame: Baseline
Locations:
city: Coimbatore
country: India
facility: PSG Hospitals
state: Tamilnadu
Study officials:
affiliation: PSG Hospitals
name: RM PL Ramanathan, MD DM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04109105: Study for the Efficacy and Security Analysis in the Protection of Ileocolic Anastomosis Conducted in Laparoscopic Right Hemicolectomy Because of Colon Cancer, Using a NHS-PEG Coated Collagen Patch.
Official title: Prospective Pilot Study for the Efficacy and Security Analysis in the Protection of Ileocolic Anastomosis Conducted in Laparoscopic Right Hemicolectomy Because of Colon Cancer, Using a Using a NHS-PEG (N-hydroxysuccinimide Functionalized Polyethylene Glycol) Coated Collagen Patch.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Adenocarcinoma Colon
Keywords: Colon neoplasia
Ascendant colon
Surgical anastomosis
Anastomotic leak
Collagen
Polyethylene glycol
Hemopatch
Lead sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Sponsor class: OTHER
First posted: 2019-09-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing a programmed right laparoscopic hemicolectomy for right colon adenocarcinoma with curative intention at the Virgen Macarena University Hospital during the necessary period of time to achieve the proposed number of patients.

Brief summary: The aim of this study is to analyse the effectiveness and security in the prevention of anastomotic leakage by protecting the ileocolic anastomosis with a reabsorbable NHS-PEG collagen patch.


Eligibility criteria: Inclusion Criteria:

* ≥ 18 years old.
* Ability to understand and make their own decision to participate in the study.
* Pre-surgery right colon adenocarcinoma pathological diagnosis.
* Patient with a mechanic, intra or extracorporeal ileocolic anastomosis.

Exclusion Criteria:

* Urgent intervention.
* Simultaneous colon cancer.
* M1 pre-surgery staging.

Primary outcomes:
measure: Effectiveness and security analysis in the prevention of anastomosis leakage through the protection of ileocolic anastomosis with NHS-PEG coated collagen patch.
timeFrame: Up to 30 days after the surgery
Secondary outcomes:
measure: Analysis of the percentage of leaks in the ileocolic anastomosis reinforced with NHS-PEG coated collagen patch.
timeFrame: Up to 30 days after the surgery
measure: Number of complications related to anastomotic leakage in patients with ileocolic anastomosis reinforced with NHS-PEG coated collagen patch.
timeFrame: Up to 30 days after the surgery
measure: Number of surgical repetitions.
timeFrame: Up to 30 days after the surgery
measure: Number of hospital readmissions.
timeFrame: Up to 30 days after the surgery
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
Study officials:
affiliation: Hospital Universitario Virgen Macarena
name: Juan Carlos Gómez Rosado
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02688205: Correlation Between Cyriax's Functional Examination and Ultrasound Examination in Patients With Shoulder Pain
Official title: Correlation Between Cyriax's Functional Examination and Ultrasound Examination in Patients With Shoulder Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Shoulder Pain
Keywords: Cyriax's functional examination
Ultrasound
Correlation
Resisted test
Lead sponsor: Shin Kong Wu Ho-Su Memorial Hospital
Sponsor class: OTHER
First posted: 2016-02-23
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with or without shoulder pain

Brief summary: Shoulder problems cause substantial disability in daily living, work, leisure activity, and exercise. The presence of shoulder problem such as rotator cuff pathology reported was highly predictive of impaired health-related quality of life.

Many tests were used for physical examination of the shoulder. The reliability and validity of the tests have been studied before. However, a systemic review concluded that there was conflicting evidence in reliability of each or combined tests. Functional examination of the shoulder by Cyriax is composed of a series of tests to evaluate a shoulder problem. It includes three arm elevation, three tests for glenohumeral joints, and six resisted tests.

As far as the investigators know, correlation of Cyriax functional examination with the ultrasonographic findings has never been reported before. Therefore, the aim of this study is to compare the clinical diagnosis by Cyriax's functional examination with ultrasound findings in patients with shoulder pain.

Detailed description: There are two groups with fifty patients in each group. First group is patients who have unilateral or bilateral shoulder pain from the outpatient clinic of Department of Physical Medicine and Rehabilitation in Shin Kong Wu Ho-Su Memorial Hospital. The other group is control group who has no shoulder problems. Both groups will receive Cyriax's functional examination of the shoulder after history taking, and will be examined by shoulder ultrasound in one week.

Eligibility criteria: Inclusion Criteria:

Study group:

1. patients with unilateral or bilateral shoulder pain with unknown causes;
2. age≥ 20 years old.

Control group:

1. patients without unilateral or bilateral shoulder pain;
2. age≥ 20 years old.

Exclusion Criteria:

1) chronic inflammatory joint disease, infections or tumors of the shoulder, previous fracture or surgery of shoulder, and referred pain from cervical origin or visceral organs.

Primary outcomes:
measure: Cyriax's functional examination for diagnosis
timeFrame: 1 week
measure: Ultrasound examination for diagnosis
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Shin Kong Wu Ho-Su Memorial Hospital
Study officials:
affiliation: Shin Kong Wu Ho-Su Memorial Hospital
name: Lin-Fen Hsieh, M.D.
role: PRINCIPAL_INVESTIGATOR
References: