louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03859856: Ovarian Reserve in Diabetes Mellitus
Official title: Ovarian Reserve in Patients With Type 1 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type1 Diabetes Mellitus
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2019-03-01
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be reproductive age women diagnosed with type 1 diabetes mellitus. The control population will be aged and BMI matched women without type 1 diabetes mellitus.

Brief summary: Type 1 diabetes mellitus is a common autoimmune disease. It affects women of all ages including reproductive years. Hyperglycemic condition in diabetes can cause organ damage. This study aims to measure serum hormones including FSH, LH, E2, AMH, ovarian volume and antral follicle count (indicators of ovarian reserve) in women with and without type 1 diabetes mellitus.

Detailed description: Type 1 diabetes mellitus is a common autoimmune disease. It affects women of all ages including reproductive years. It is showed that hyperglycemic state in diabetes results in organ damage like kidneys and eyes. Ovarian reserve is important for the reproductive period. The measurements of serum hormones including follicle stimulating hormone (FSH), luteinizing hormone (LH), estradiol (E2) and anti-mullerian hormone (AMH) will give us an idea about the ovarian reserve. The investigators aim is to measure ovarian reserve parameters in patients diagnosed with type 1 diabetes mellitus and to compare them to healthy controls. Serum FSH, LH, E2 and AMH will be measured on the 3rd day of the cycle. Antral follicle count and ovarian volume measurement will be done with ultrasonography. Ovarian reserve markers will be compared between the groups.

Eligibility criteria: Inclusion Criteria:

* Reproductive age group women: 18-40 years
* Women diagnosed with type 1 diabetes (case group)
* Women without type 1 diabetes (control group)

Exclusion Criteria:

* Women with PCOS (polycystic ovary syndrome)
* history of ovarian surgery
* Body mass index (BMI) over 30

Primary outcomes:
measure: E2, FSH, LH, AMH levels
timeFrame: during procedure
measure: antral follicle count
timeFrame: during procedure
measure: ovarian volume
timeFrame: during procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kanuni SSTRH
Study officials:
References:
Clinical trial NCT06974656: Infusion of Dexmedetomidine Versus Lidocaine in Management of Acute Postoperative Pain After Modified Radical Mastectomy
Official title: Intraoperative Intravenous Infusion of Dexmedetomidine Versus Lidocaine in Management of Acute Postoperative Pain After Modified Radical Mastectomy: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Infusion
Dexmedetomidine
Lidocaine
Acute
Postoperative Pain
Modified Radical Mastectomy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-05-16
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to compare the effect of intraoperative intravenous infusion of dexmedetomidine and lidocaine in the management of acute postoperative pain after mastectomy.

Detailed description: Postoperative pain control continues to remain suboptimal, despite multimodal analgesia regimes, minimally invasive surgical techniques, and enhanced recovery programs. Acute postoperative pain hinders patients' functional recovery and represents one of the greatest predictive factors for transition to chronic postsurgical pain.

Among adjuvants, dexmedetomidine, a highly selective α2 adrenoreceptor agonist, and lidocaine, a well-established local anesthetic, seem promising for this purpose.

Eligibility criteria: Inclusion Criteria:

* Age from 18 to 65 years.
* American Society of Anesthesiology (ASA) physical status II.
* Body mass index (BMI) 18.5-35 kg/m2.
* Scheduled for modified radical mastectomy.

Exclusion Criteria:

* Patient's refusal.
* Contraindication to the use of local anesthetics.
* Cardiovascular disease.
* Significant renal/hepatic impairment
* Insulin-dependent diabetes mellitus.
* Central nervous system or psychiatric disease.
* Use of opioids/steroids/clonidine/other α2 agonist/analgesics or any drugs acting on the central nervous system during the previous 2 weeks.
* Drug/alcohol abuse.
* Inability to comprehend the pain assessment scale.

Primary outcomes:
measure: Time to the 1st rescue analgesia
timeFrame: 48 hours postoperatively
Secondary outcomes:
measure: Mean arterial pressure
timeFrame: Till the end of surgery (Up to 2 hours)
measure: Heart rate
timeFrame: Till the end of surgery (Up to 2 hours)
measure: Total morphine consumption
timeFrame: 48 hours postoperatively
measure: Degree of pain
timeFrame: 48 hours postoperatively
measure: Incidence of adverse events
timeFrame: 48 hours postoperatively
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References:
Clinical trial NCT04637685: The Effect of Infusion Pressure on the Outcomes of Phacoemulsification Surgery; the ENHANSE Study
Official title: The Enhanse Study The Effect of Infusion Pressure on the Outcomes of Phacoemulsification Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cataract
Lead sponsor: South Tyneside and Sunderland NHS Foundation Trust
Sponsor class: OTHER
First posted: 2020-11-20
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The effect of infusion pressure on the outcomes of phacoemulsification surgery.

Detailed description: The Centurion phacoemulsification system with active sentry allows efficient cataract surgery with safe use of high vacuums, whilst allowing low and physiological infusion pressures, significantly lower than other surgical systems. There are reasons to expect that this will lead to patient benefit but it is uncertain if low infusion pressure during phacoemulsification will lead to improved outcomes. This is of particular interest in patients with vascular retinopathies such as diabetic retinopathy where the retinal vasculature is compromised, as well as glaucoma and other optic neuropathies where there is established nerve fibre layer loss.

The investigator will carry out a feasibility study with a two surgeon RCT of 70 patients with diabetic retinopathy and/or glaucoma undergoing phacoemulsification with randomisation of two different infusion pressures (low (30mmHg) versus the higher pressure (\~70mmHg) as currently used) using the active sentry system with assessment of a range of exploratory endpoints.

Eligibility criteria: Inclusion Criteria:

* Patients with cataract undergoing routine phacoemulsification with either diabetic retinopathy or glaucoma of any degree

Exclusion Criteria:

* Dense cataract precluding adequate retinal imaging
* posterior polar cataract
* subluxated cataract,
* other vision affecting pathology,
* severe glaucoma

Primary outcomes:
measure: Recruitment rate
timeFrame: From the start to the end of the 10 month planned recruitment period
Secondary outcomes:
measure: Retinal thickness on SD OCT
timeFrame: Between baseline and day 40
measure: Foveal avascular zone size on optical coherence tomography angiography between baseline and day 40
timeFrame: Between baseline and day 40
Other outcomes:
Locations:
Study officials:
affiliation: South Tyneside and Sunderland NHS Trust
name: David Steel
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02815085: RecoverLINK Technology Pilot for HF Patients
Official title: Pilot to Assess Feasibility of Using RecoverLINK Technology to Supplement Outpatient Care for Heart Failure Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: heart failure
mHealth
Lead sponsor: RecoverLINK
Sponsor class: INDUSTRY
Collaborators: name: Mount Sinai Hospital, New York
name: Digital Health Marketplace (previously Pilot Health Tech NYC)
First posted: 2016-06-28
Enrollment: 46
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The primary objective is to examine feasibility of incorporating RecoverLINK into the standard of care as a function of (i) user engagement, (ii) user satisfaction, and (iii) workflow efficiency. As secondary objectives, the investigators will collect preliminary data to examine the association between patient engagement with the RecoverLINK app and (i) changes in patient knowledge and behavior, and (ii) hospital readmission(s) at 30, 60, and 90-day time periods post-enrollment.


Eligibility criteria: Inclusion Criteria:

* Heart failure (HF) patients with a rapid follow up appointment scheduled at the Mount Sinai HF clinic
* English-speaking
* With either access to (i) an iOS smart device or (ii) wifi at-home

Exclusion Criteria:

Patients meeting any of the following criteria:

* A heart transplant
* A mechanical circulatory support (MCS) device
* An altered mental status
* Serious co-morbidities (as identified by Mount Sinai team)
* Cognitive impairments (as identified by Mount Sinai team)
* Inability to use technology (as identified by Mount Sinai team)

Primary outcomes:
measure: User engagement: # symptom surveys completed/30 days
timeFrame: 30 days
measure: User satisfaction: Percent patients report "satisfied" via post-program survey
timeFrame: 30 days
measure: Workflow efficiency: mean/median time to resolution of patient alerts
timeFrame: 30 days
Secondary outcomes:
measure: Mean difference in pre/post SCHIFI score
timeFrame: 30 days
measure: Hospital admission
timeFrame: 30, 60, 90 days
Other outcomes:
Locations:
city: New York
country: United States
facility: The Mount Sinai Hospital
state: New York
Study officials:
affiliation: The Mount Sinai Hospital
name: Sean Pinney, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06434285: A 4Pi Questionnaire for Service User and Carer Involvement Experience
Official title: Development of a 4Pi Framework-based Questionnaire to Evaluate Service User and Carer Involvement Experience in SLaM
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Mental Health
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: South London and Maudsley NHS Foundation Trust
First posted: 2024-05-30
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Service users and carers with experience in service involvement activities.

Brief summary: Service user (SU) and carer involvement in planning healthcare services and improving their quality is crucial and required by the NHS. Research has shown that SUs and carers can greatly benefit healthcare; however, effective involvement can be challenging due to barriers such as language, lack of training or support, and undervaluing the input of patients and the public compared to that of professionals.

The 4Pi framework sets out standards for good involvement practices by focusing on principles such as respect and inclusivity, shared purposes, diversity, accurate planning, and ensuring involvement leads to improvements in people's lives.

This study, funded by King's Health Partners, aims to take the 4Pi framework a step further by developing a questionnaire to evaluate how well patients and carers are involved in improving mental health services. The researchers will work closely with SUs and carers to create this questionnaire, with the ultimate goal to ensure that involvement in healthcare leads to real, positive changes for everyone involved.

The research questions for the study is: to what extent, from SUs and carers' perspectives, is the questionnaire understandable and successful in capturing the meaning of 4Pi domains?

To be eligible for the study, participants need to be at least 18 years old and have experience of involvement activities/projects in SLaM. Researchers, SUs, and carers will define the questionnaire to ensure it is understandable, comprehensive, and feasible; this will be done via virtual (or in person at Denmark Hill/King's College London campus depending on participants' preferences) group interviews. The questionnaire will then be piloted on a small sample of individuals, and the final questionnaire refined based on any potential additional feedback from them.

This study is part of the King's Improvement Science programme's research portfolio that is funded by King's Health Partners.


Eligibility criteria: Inclusion Criteria:

1. be at least 18 years old;
2. have experience of being involved in service involvement activities in SLaM NHS Foundation Trust.

Exclusion Criteria:

a) No experience of being involved in service improvement activities.

Primary outcomes:
measure: Questionnaire
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03565185: Comparison Of Two Different Type Robot Assisted Gait Training In Rehabilitation Of Stroke
Official title: Comparison Of An Exoskeleton Device With An End-Effector Device In Robotic Gait Assesment Of Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Erenköy Physical Therapy and Rehabilitation Hospital
Sponsor class: OTHER
First posted: 2018-06-21
Enrollment: 64
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: Investigators aimed to compare the results of rehabilitation with an exoskeleton device(Robogait) and with an end-effector device(Lokohelp)

Detailed description: There are different types of devices in robotic rehabilitation which has been used in recent years for stroke. Investigators aimed to compare the results of rehabilitation with an exoskeleton device(Robogait) and with an end-effector device(Lokohelp) in robot-assisted gait training of stroke rehabilitation

Eligibility criteria: Inclusion Criteria:

* Rehabilitation need for stroke
* Patients under FAC stage 4
* No contraindications for robotic rehabilitation
* Subacute stroke

Exclusion Criteria:

* The robot-orthosis does not fit the patient's body
* Inadequate body weight (obesity)
* Severe contractures
* Bone instability (nonstable spinal cord fracture and severe osteoporosis)
* Circulation problems
* Cardiac problems
* Open wounds on the lower extremities or in the body where they will come into contact with the orthosis
* Uncoordinated, psychotic or aggressive patients
* Serious cognitive disorders
* Patients with long-term infusion therapy
* Hip, knee, ankle arthrodesis
* Epilepsy
* Patients with disproportionate limb or vertebrae, such as bone cartilage dysplasia
* Those with severe vascular problems of the lower extremity
* Conditions requiring rest or immobilization, such as osteomyelitis and other inflammatory/infectious diseases
* Severe respiratory diseases

Primary outcomes:
measure: 6 minute walk test
timeFrame: 4 weeks
measure: 10 meter walking test
timeFrame: 4 weeks
measure: Postural Assessment Scale for Stroke(PASS)
timeFrame: 4 weeks
Secondary outcomes:
measure: FAC(Functional Ambulation Classification)
timeFrame: 4 weeks
measure: Barthel Index
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Erenkoy physical treatment and rehabilitation hospital
state: In The USA Or Canada, Please Select...
Study officials:
affiliation: Dr.
name: Aylin SARI
role: STUDY_CHAIR
References:
Clinical trial NCT04346485: Comparison of SP TFL and Ho:YAG for RIRS Using 145 µm and 200 µm Fibers
Official title: Prospective Randomized Comparison of SP TFL and Ho:YAG for RIRS Using 145 µm and 200 µm Fibers for the Management of Lower Pole Kidney Stones: Single-center Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Kidney Stone
Nephrolithiasis
Urolithiasis
Keywords: RIRS
holmium laser
superpulse thulium laser
kidney stone disease
Lead sponsor: I.M. Sechenov First Moscow State Medical University
Sponsor class: OTHER
First posted: 2020-04-15
Enrollment: 105
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 authors hypothesize that the RIRS using 150-microm Tm-fiber laser is superior than fiber with larger diameters, as 200-microm Tm-fiber laser or 200-microm holmium fiber laser, in such points as follows:

* decreasing surgery time and laser-on time due to possibility of 4.3 fold ablation efficacy increase, which has been shown by Andreeva et al.;
* increasing the flexible ureteroscope tip deflection lower pole stones availability;
* decreased risk of complications and a better irrigation and visualization due to better irrigation with smaller fiber;
* increasing of lithotripsy efficacy and laser beam density by lowering of beam focal spot due to using of lesser fiber diameter

Detailed description: RIRS will be performed with SP TFL or Ho:YAG (100 W). The procedure is performed under general anesthesia with the patient in the dorsal lithotomy position. The bladder is entered either with a cystoscope or a semi-rigid ureterorenoscope. Guidewires (0.035") will be used to facilitate access (under fluoroscopic guidance). After access sheath (12/14) will be placed up to the kidney pelvis. Through the access sheath ureteroscope will be introduced. For nephrolithotripsy 145 mcm and 200 mcm fibers will be used. Large fragments could be extracted with nitinol basket. After the surgery ureteral stent (7 Fr.) will be placed inside the ureter for 10 to 14 days.

A 10 Fr urethral catheter can be placed in the bladder for the drainage of the bladder during the operation.

Eligibility criteria: Inclusion Criteria:

* Males and Females \> 18 y.o.;
* Radiologically confirmed (CT) kidney stone;
* Stone size from 10 to 20 mm.

Exclusion Criteria:

• Multiple (more than 3) kidney stones \> 5 mm

Primary outcomes:
measure: Laser-on time
timeFrame: during surgery
Secondary outcomes:
measure: adverse events
timeFrame: during surgery and 6 months after surgery
measure: Operative time
timeFrame: during surgery
measure: Hemoglobin drop
timeFrame: 1 day after surgery
measure: Catheter stay
timeFrame: 1 week
measure: hospitalization length
timeFrame: 1 week
measure: Radiation exposure
timeFrame: during surgery
measure: Radiation exposure
timeFrame: during surgery
measure: Stone-free rate
timeFrame: 3 month
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Institute for Urology and Reproductive Health, Sechenov University.
Study officials:
References:
Clinical trial NCT01613885: Understanding and Diagnosing Allergic Disease in Twins
Official title: Understanding and Diagnosing Allergic Disease in Twins
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Allergies
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2012-06-07
Enrollment: 340
Sex: ALL
Minimum age (years): 0
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers are not specifically targeted. Healthy non-allergic study participants may be found through the course of evaluation for the presence of allergies. Women, minorities or children will not be excluded from this study.

Brief summary: The purpose of this study is to gain better understanding of how the immune system works in twins with and without allergic disease. Healthy volunteers are not specifically targeted. Healthy non-allergic study participants may be found through the course of evaluation for the presence of allergies.

Detailed description: The purpose of this study is to study the genetic control and gain better understanding of how the immune system works in twins with and without allergic disease. Although healthy volunteers are not specifically targeted, they might be identified when non-allergic study participants are found through the course of evaluation for the presence of allergies.

Eligibility criteria: Inclusion Criteria:

* Twin participants ages 0 to 80 years who are with or without allergy disease.

Exclusion Criteria:

* Patients with special risks attendant to venipuncture will be excluded.

Primary outcomes:
measure: Comparing immune systems of food allergic twins
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Sean N Parker Center for Allergy and Asthma Research at Stanford
state: California
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Kari Nadeau, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bao R, Hesser LA, He Z, Zhou X, Nadeau KC, Nagler CR. Fecal microbiome and metabolome differ in healthy and food-allergic twins. J Clin Invest. 2021 Jan 19;131(2):e141935. doi: 10.1172/JCI141935.