louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06758089: A Clinical Comparison of Two Soft Toric Contact Lenses
Official title: A Clinical Comparison of Two Soft Toric Contact Lenses
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Astigmatism
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2025-01-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the short-term clinical performance of two toric contact lenses.

Detailed description: The aim of this study is to evaluate the short-term clinical performance of two toric contact lenses when compared to each other after 15 minutes of daily wear each.

Eligibility criteria: Inclusion Criteria:

1. They are of legal age and capacity to volunteer.
2. They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
3. They are willing and able to follow the protocol.
4. They currently wear soft contact lenses, or have done so within the past two years.
5. They have ocular astigmatism in both eyes of between 0.75DC and 2.00DC.
6. They have a spherical component: plano to -7.00DS (based on ocular refraction).
7. They are expected to be able to be fitted with the study lenses within the power range available.

Exclusion Criteria:

1. They have an ocular disorder, which would normally contra-indicate contact lens wear.
2. They have a systemic disorder, which would normally contra-indicate contact lens wear.
3. They are using any topical medication such as eye drops or ointment.
4. They are aphakic.
5. They have had corneal refractive surgery.
6. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
7. They are pregnant or breastfeeding.
8. They have an eye or health condition including an immunosuppressive or infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or a history of anaphylaxis or severe allergic reaction.
9. They have taken part in any contact lens or care system clinical research within two weeks prior to starting this study.

Primary outcomes:
measure: Subjective Overall Score
timeFrame: At the end of 15 minutes of daily wear
Secondary outcomes:
measure: Subjective Vision
timeFrame: At the end of 15 minutes of daily wear
measure: Subjective Comfort
timeFrame: At the end of 15 minutes of daily wear
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Eurolens Research
Study officials:
affiliation: Eurolens Research
name: Carole Maldonado-Codina, PhD, FBCLA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00770289: Study Comparing Remission Rates, in Patients With Major Depressive Disorder (MDD)
Official title: Open Label, Observational, Non-interventional Study for the Evaluation of Remission Rates in Patients With MDD Under Treatment With Various Anti-depressives
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Major Depressive Disorder
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-10-09
Enrollment: 851
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed with MDD who are either changing treatment or have never received treatment.

Brief summary: Tools known as 'depression scales 'are widely used as assessments to evaluate a patient's response to treatment. The purpose of this study is the evaluation of the remission rates for patients with MDD. The evaluation will involve the use of HAM-D 17, and HAM-D 7 questionnaires and the comparison of those questionnaires.

Detailed description: 12 weeks random

Eligibility criteria: Inclusion Criteria:

* Outpatients
* 18-75 years old
* Patients diagnosed with MDD according to DSM IV without psychotic symptoms
* HAM-D17 \> or = 18 on inclusion
* Patients receiving treatment for the first time or changing treatment based on their doctor's decision

Exclusion Criteria:

* Subjects with potentially problematic compliance
* Subjects participating in an interventional trial within the last 3 months

Primary outcomes:
measure: Percentage of Participants With Remission Based on Hamilton Depression Scale (HAM-D)
timeFrame: Week 12
Secondary outcomes:
measure: Percentage of Participants With Remission Based on Beck Depression Inventory (BDI)
timeFrame: Week 12
measure: Hamilton Depression Scale 17 (HAM-D17), HAM-D7 and Beck Depression Inventory (BDI)
timeFrame: Baseline, Week 12
measure: Number of Participants With Residual Symptoms in Case of Non Remission
timeFrame: Week 12
Other outcomes:
Locations:
city: Haidari
country: Greece
facility: Pfizer Investigational Site
state: Athens
city: Haidari
country: Greece
facility: Pfizer Investigational Site
state: Athens
city: Ilissia
country: Greece
facility: Pfizer Investigational Site
state: Athens
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT06128889: Evaluation of a Supporting Transition and Resilience to Clinical Nursing Education (STRONG) Study
Official title: Evaluation of a Supporting Transition and Resilience to Clinical Nursing Education (STRONG) Study - A Mixed Methods Evaluation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Resilience
Practice Readiness
Depression
Anxiety
Stress
Physical Activity
Eating Behaviours
Lead sponsor: National University of Singapore
Sponsor class: OTHER
First posted: 2023-11-13
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study aims to address the following research questions:

1. Evaluate the effectiveness of a Supporting Transition and Resilience to Clinical Nursing Education (STRONG) program on first year nursing students' anxiety, depression, stress, resilience, practice readiness, physical activity and eating behaviours.
2. Explore first year nursing students' experiences and perception of the STRONG program.

Participants will be invited to participate in an asynchronous online STRONG program


Eligibility criteria: Inclusion Criteria:

* First year nursing students enrolled in the NUR1107B Nursing Practice Experience and NUR1202C Clinical Experience I module
* Above the ages of 18 years
* Able to comprehend the English language
* Have a device that can connect to the Internet

Exclusion Criteria:

* Students who refused to participate in this study

Primary outcomes:
measure: Resilience
timeFrame: Before training
measure: Resilience
timeFrame: Immediately after training
measure: Resilience
timeFrame: 1 month after training
measure: Depression, Anxiety, and Stress
timeFrame: Before training
measure: Depression, Anxiety, and Stress
timeFrame: Immediately after training
measure: Depression, Anxiety, and Stress
timeFrame: 1 month after training
measure: Practice Readiness
timeFrame: Before training
measure: Practice Readiness
timeFrame: Immediately after training
measure: Practice Readiness
timeFrame: 1 month after training
measure: Physical activity
timeFrame: Before training
measure: Physical activity
timeFrame: Immediately after training
measure: Physical activity
timeFrame: 1 month after training
measure: Eating behaviours
timeFrame: Before training
measure: Eating behaviours
timeFrame: Immediately after training
measure: Eating behaviours
timeFrame: 1 month after training
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: National University of Singapore
name: Darryl Ang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05110989: A Multicenter Patient Registry on Outcomes From Cryoanalgesia of the Intercostal Nerves
Official title: The CryoICE™ Cryoanalgesia Registry for Pain Management in Post-cardiothoracic Surgery Via Cryoablation of the Intercostal Nerves
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Post Operative Pain
Lead sponsor: AtriCure, Inc.
Sponsor class: INDUSTRY
First posted: 2021-11-08
Enrollment: 5000
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The REDUCE registry eligibility is open to sites and physicians performing cryo nerve block procedures as treatments for patients to generate croanalgesia as a post operative pain management method using the AtriCure Cryo Nerve Block (cryoNB) Device Family. Subjects must have been scheduled to undergo or have undergone the cryo nerve block procedure and must meet all eligibility criteria in order for their treatment and results to be considered for this registry.

Brief summary: This is a retrospective and prospective, multicenter, observational patient registry to record outcomes from patients undergoing cryoablation of the intercostal nerves (cryoanalgesia) for post-operative pain management.


Eligibility criteria: Inclusion Criteria:

1. Patients whose age is 12 years or above, and are able to give informed consent/assent specific to state and national law.
2. Patients have been scheduled by physician(s) to undergo or have undergone cryoablation of the intercostal nerves utilizing at least one AtriCure device or are similar patients treated without the use of cryoablation

Exclusion Criteria:

1. Patient is enrolled in a concurrent trial that may impact the treatment offered by the registry devices.
2. Patient with exclusion criteria required by local governance.
3. Women of childbearing potential who are, or plan to become, pregnant during the time of the study

Primary outcomes:
measure: Efficacy of cryo nerve block to generate cryoanalgesia as post operative pain management
timeFrame: From enrollment to 5 years after date of index procedure
measure: Safety of cryo nerve block to generate cryoanalgesia as post operative pain management
timeFrame: From enrollment to 5 years after date of index procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: AdventHealth
state: Florida
city: Rochester
country: United States
facility: Henry Ford Health Rochester Hospital
state: Michigan
city: Kansas City
country: United States
facility: St. Luke's Hospital of Kansas City
state: Missouri
city: Manchester
country: United States
facility: Elliot Hospital
state: New Hampshire
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: Elliot Hospital
name: Curits Quinn, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06581289: Cardiac Anesthesia Registry Including Biosignal Database for Prognostication of Postoperative Renal Outcome
Official title: Cardiac Anesthesia Registry Including Biosignal Database for Prognostication of Postoperative Renal Outcome: Cardiac Anesthesia Renal Outcome in Severance Cardiovascular Hospital - DataBase (CARS-DB)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cardiac Anaesthesia
Keywords: Acute Kidney Injury
Cardiovascular Surgical Procedures
Cardiopulmonary Bypass
Biomarker
Biosignal data
Renal outcome
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2024-09-03
Enrollment: 10000
Sex: ALL
Minimum age (years): 19
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 19 year and older admitted to Severance cardiovascular hospital for cardiac surgery using CPB (Cardiopulmonary bypass).

Brief summary: AKI(Acute Kidney Injury) is a common complication after cardiac surgery which is associated with increased mortality and morbidity. Collecting perioperative biosignal data and studying their association with renal outcomes can help improve kidney injury, mortality, and morbidity in cardiac surgical patients. Furthermore, the occurrence of AKI, length of hospital stay, and recovery of renal function after discharge are closely associated with the development of chronic kidney disease (CKD). Therefore, regular monitoring of renal function and related indicators in cardiac surgical patients can help improve long-term outcomes.


Eligibility criteria: Inclusion Criteria:

* Aged 19 years and older scheduled for cardiac surgery using CPB

Exclusion Criteria:

* emergency operation, the patient is foreigner or illiterate and unable to read the consent form

Primary outcomes:
measure: post-operative AKI incidence within 1 week after cardiac surgery with CPB
timeFrame: within first 7 days after surgery
Secondary outcomes:
measure: MAKE 30 (Major adverse kidney event within 30 days)
timeFrame: within 30 days after surgery
measure: MAKE 90 (Major Adverse kidney event within 90 days)
timeFrame: within 90 days after surgery
measure: incidence of CKD (chronic kidney disease) within 1 year
timeFrame: within 1 year after surgery
measure: 1 year mortality
timeFrame: within 1 year after surgery
measure: in-hospital mortality
timeFrame: from day of hospitalization for surgery until discharge after surgery 1year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References:
Clinical trial NCT02143089: Catheterization During Second Elective Caesarean Delivery
Official title: Evaluation OF Use Versus Non Use of Urinary Catheterization During Second Elective Caesarean Delivery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Wound Infection
Keywords: CCSWI
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2014-05-20
Enrollment: 220
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Use versus non use of urinary catheterization during Second Elective caesarean delivery:

Detailed description: Evaluation OF use versus non use of urinary catheterization during Second Elective caesarean delivery:by urine analysis 24 hours postoperative to exclude urinary tract infection.

Eligibility criteria: inclusion criteria

* pregnant females who will undergo second elective caesarean section at full term pregnancy (38:41 weeks gestational age).

Exclusion Criteria:

* Women with history of more than one previous caesarean Section.
* Women with history of a tonic postpartum hemorrhage.
* Women with Urinary tract infection in present pregnancy.
* Women with diabetes mellitus in present pregnancy.
* Women with medical disorder in present pregnancy that obligate monitoring of urine output during and after caesarean section, such as severe pre-eclampsia or renal disease with pregnancy.
* Emergency caesarean section

Primary outcomes:
measure: Urine analysis to diagnosed urinary tract infection by leucocytes more than 10 per high power field
timeFrame: participants will be followed for the duration of urinary tract infection,an expected average 2 days.
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: AinShamsU
Study officials:
affiliation: Ain Shams University
name: Amr Helmy, Master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04574089: Treatment for Aerobic Vaginitis by Using Bofukang Vaginal Suppository
Official title: Medical Ethics Committee of Peking University Shenzhen Hospital
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Vaginitis
Keywords: Aerobic vaginitis
Treatment
Lead sponsor: Peking University Shenzhen Hospital
Sponsor class: OTHER
First posted: 2020-10-05
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aerobic vaginitis was treated by using Baofukang Suppository 7 days group or Baofukang Suppository 14 days group.To evaluate the efficacy and safety after treatment.

Detailed description: Aerobic vaginitis was treated by using Baofukang Suppository 7 days group or Baofukang Suppository 14 days group.

Group 1: Baofukang Suppository (1.74g), for vaginal use, 2 capsules per night for 7 days.

Group 2: Baofukang Suppository (1.74g), for vaginal use, 2 capsules per night for 14 days.

The efficacy and safety will be evaluated 7\~14 days after treatment and 35\~42 days after treatment.

Eligibility criteria: Inclusion Criteria:

Aerobic vaginitis diagnosed based on present ：

1. Vaginal dischareg ;
2. pH \> 4.5;
3. Donders score≥3;

Exclusion Criteria:

1. Patients with other vaginitis, cervical erosion, or suspected gonorrhea, herpes simplex virus infection and other vulvar diseases;
2. Patients received systemic or vaginal antifungal or antibiotic treatment within two weeks before admission.
3. Pregnancy, lactation and intentional pregnancy;
4. Women with liver and kidney dysfunction, low immune function, diabetes, psychosis or other serious diseases;
5. Allergic constitution and patients allergic to drug ingredients in this study;
6. Those with poor compliance.

Primary outcomes:
measure: Cure rate
timeFrame: First week after treatment
measure: Cure rate
timeFrame: First month after the treatment
Secondary outcomes:
measure: Side affect
timeFrame: First week after treatment
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Peking University Shenzhen Hosptal
state: Guangdong
Study officials:
affiliation: Dept of Obstetrics and Gynecology,Peking University Shenzhen Hospital
name: Shangrong Fan, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03777189: Cognitive-Behavioral and Physical Activity Interventions for Binge Eating and Overweight
Official title: Cognitive-Behavioral and Physical Activity Interventions for Binge Eating and Overweight
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Binge-Eating Disorder
Binge Eating
Overweight and Obesity
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2018-12-17
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims to perform an open-series pilot trial to examine the efficacy of cognitive-behavioral therapy delivered in a guided self-help format (CBTgsh) with added content related to physical activity (PA), for the treatment of binge-eating disorder (BED), operationalized as BED full diagnostic criteria or BED with the full criteria except for the binge episode size criterion.


Eligibility criteria: Inclusion Criteria:

1. 18 to 65 years old;
2. Meet DSM-5 criteria for BED or BED but without the size criterion (LOC eating);
3. BMI 25-45 kg/m2;
4. Sedentary activity pattern (\< 90 mins/week of moderate-to-vigorous intensity recreational physical activity);
5. Available for the duration of the treatment and follow-up (7 months);
6. Read, comprehend, and write English at a sufficient level to complete study-related materials.

Exclusion criteria:

1. Co-existing psychiatric condition that requires hospitalization or more intensive treatment (e.g., bipolar mood disorders, psychotic illnesses, severe depression).
2. Reports active suicidal or homicidal ideation.
3. Current anorexia or bulimia nervosa.
4. Contraindications to physical activity.
5. Blood pressure \>140 systolic or \>90 diastolic.
6. Breast-feeding or pregnant, or planning to become pregnant during the study.
7. History of stroke or myocardial infarction.
8. Current or recent (within 12 months) drug or alcohol dependence
9. Currently receiving effective treatment for eating or weight loss.
10. Currently participating in another clinical study.

Primary outcomes:
measure: Binge-eating frequency
timeFrame: Post-treatment (4 months)
measure: Body mass index
timeFrame: Post-treatment (4 months)
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
Study officials:
affiliation: Yale University
name: Carlos Grilo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02312089: GnRHa for Luteal Phase Support in GnRH Antagonist Protocol Cycles
Official title: Gonadotropin Releasing Hormone Agonist for Luteal Phase Support in Gonadotropin Releasing Hormone Antagonist Protocol Cycles
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Infertility
Keywords: Luteal phase support, ICSI, GnRHa
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2014-12-09
Enrollment: 200
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Evaluation of the effect of adding a single dose of gonadotropin releasing hormone agonist (GnRHa) as a luteal phase support on the outcomes of intracytoplasmic sperm injection (ICSI) following GnRH antagonist protocol

Detailed description: Endometrial preparation for embryo transfer (ET) will be started after oocyte retrieval by giving 800 mg/day natural progesterone vaginal supplement + 4 mg/day estradiol oral supplement. The patients will be randomly divided into 2 groups for luteal phase support: (i) Group A (GnRHa group) in which the luteal phase support will be continued by the same regimen started on the day of oocytes retrieval until 2 weeks after embryo transfer (ET) with subcutaneous administration of a single dose (0.2 mg) of GnRHa (Triptorelin) 6 days after oocyte retrieval, and (ii) Group B (control group) in which the luteal phase support will be continued only by the same regimen started on the day of oocytes retrieval until 2 weeks after ET

Eligibility criteria: Inclusion Criteria:

* Women subjected to ICSI through controlled ovarian hyperstimulation (COH) with pituitary downregulation by GnRH antagonist.

Exclusion Criteria:

* Moderate or severe endometriosis.
* Hydrosalpinx.
* Uterine abnormalities.
* Myoma.
* Previous uterine surgery.

Primary outcomes:
measure: Clinical pregnancy rate
timeFrame: 6 weeks after embryo transfer
Secondary outcomes:
measure: Implantation rate
timeFrame: 6 weeks after embryo transfer
measure: Miscarriage rate
timeFrame: 12 weeks gestational age
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Fertility Care Unit (FCU) in Mansoura University Hospital
state: Dakahlia
city: Mansourah
country: Egypt
facility: Private fertility care centers
state: Dakahlia
Study officials:
affiliation: Mansoura University
name: Mohamed S Abdelhafez, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Port Said University
name: Waleed El-refaie, Dr
role: STUDY_DIRECTOR
References: