louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06850064: Efficacy and Safety of Pulsed Field Ablation in Refractory Mitral Isthmus-dependent Atrial Flutter: Pulsed Field Ablation Vs. Radiofrequency Ablation: a Preliminary Randomized Controlled Study
Official title: Efficacy and Safety of Pulsed Field Ablation in Refractory Bisththis-dependent Atrial Flutter: Pulsed Field Ablation Vs. Radiofrequency Ablation: a Preliminary Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Atrial Fibrillation (AF)
Keywords: Mitral Isthmus
PFA
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
First posted: 2025-02-27
Enrollment: 60
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: Efficacy and safety of pulsed field ablation in refractory mitral isthmus-dependent atrial flutter: pulsed field ablation vs. radiofrequency ablation: a preliminary randomized controlled study

Detailed description: This study aims to compare the effectiveness of pulse field ablation (PFA) versus radiofrequency ablation (RFCA) in improving mitral valve commissural block rate and atrial tachycardia recurrence rate in patients with refractory mitral valve commissural-dependent atrial flutter.

Study Design:

Randomized Groups: Patients will be randomly assigned to two groups:

Pulse Field Ablation (PFA) Group Radiofrequency Ablation (RFCA) Group

Eligibility criteria: Inclusion Criteria:

1.Patients aged ≥18 years. 2.Diagnosed with persistent symptomatic refractory mitral valve commissural-dependent atrial flutter. Refractory mitral valve commissural-dependent atrial tachycardia is defined as:

1. Failure of drug therapy: At least one Class I or III antiarrhythmic drug (e.g., propafenone, amiodarone) fails to effectively control or prevent episodes.
2. Failure of catheter ablation: At least one previous attempt at radiofrequency catheter ablation (RFCA) targeting the mitral valve commissure has been unsuccessful (either due to recurrence post-procedure or failure to achieve bidirectional block at the commissure).

3.Intolerant to at least one antiarrhythmic drug (AAD). 4.The patient must be capable of and willing to provide written informed consent to participate in this study.

Exclusion Criteria:

1. Pregnant or breastfeeding women.
2. Presence of left atrial thrombus on preoperative imaging.
3. Life expectancy less than 1 year.
4. Coagulation disorders or contraindications to anticoagulant therapy.

Primary outcomes:
measure: Achieve persistent mitral isthmus block
timeFrame: Immediate post-operative mitral isthmus block rate.
Secondary outcomes:
measure: Episodes of atrial fibrillation, atrial flutter, or atrial tachycardia lasting ≥30 seconds occurred.
timeFrame: During the 3-month post-operative follow-up.
measure: The safety endpoint
timeFrame: During the 3-month post-operative follow-up.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Chest Hospital
Study officials:
References:
Clinical trial NCT00789464: Probiotics for Girls With Recurring Urinary Tract Infections
Official title: H-23187: Probiotic Prophylaxis Against Recurrent Pediatric Urinary Tract Infection
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Recurrent Urinary Tract Infection
Keywords: Urinary Tract Infection
Probiotics
Dietary Supplements
Bacteriuria
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2008-11-11
Enrollment: 0
Sex: FEMALE
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Probiotics are dietary supplements containing potentially beneficial bacterial strains such as Lactobacillus. The safety of oral administration of probiotics has been demonstrated in hundreds of studies using adults over the last 30 years. Very few studies have been conducted with children. UTI in girls occur when virulent bacteria migrate from the rectum and colonize the vagina and peri-urethral mucosa, thus gaining access to the bladder.

This study will randomize girls to ARM A (probiotics + placebo) and ARM B (antibiotics + placebo) to determine if UTIs are decreased when the probiotics are given.


Eligibility criteria: Inclusion Criteria:

* Girls age 1 through age 17 years of age
* Must have had at least 3 symptomatic UTI, uncomplicated or complicated, in the year preceding study inclusion or already using any form of prophylaxis to prevent recurrences of UTI
* Must have had at least 3 symptomatic urinary tract infections in the year before the start of the prophylaxis.

Exclusion Criteria:

* Breastfeeding
* Pregnancy
* Prior adverse reaction to sulfa drugs or sulfamethoxazole/trimethoprim
* Known immunosuppression i.e., transplant recipients or children with congenital immunodeficiencies
* Poorly controlled diabetes
* Untreated HIV infection
* Use of high dose corticosteroids for autoimmune diseases or post-organ transplantation. Inhaled corticosteroids or oral steroids for asthma are allowed.
* Malnutrition
* Patients with a history of sulfamethoxazole/trimethoprim-resistant UTI will be excluded from the study
* Patients with renal insufficiency, liver insufficiency, or cardiopulmonary disease requiring medication will be excluded from the study
* Patients with known anemia will be excluded from the study
* Patients taking medications that may interact with sulfamethoxazole/trimethoprim will be excluded from the study
* Patients taking other probiotics will be excluded from the study
* Patients already taking prophylactic antibiotics will be excluded from the study

Primary outcomes:
measure: The primary outcome will be the rates of bacteriuria among the subjects and the comparison of the two arms.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: David R. Roth, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06976164: Reflexo Therapy for Gestational Diabetes Mellitus
Official title: The Effects of Reflexo Therapy of Sole on Gestational Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Physical Therapy
Keywords: Gestational diabetes mellitus
Foot reflexology
Fasting plasma glucose
2-h post-prandial glucose
HbA1c
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2025-05-16
Enrollment: 36
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study will be to detect the effects of Reflexo therapy of sole on GDM.

Detailed description: Gestational diabetes mellitus is considered a hazard factor for antenatal complications for both mother and fetus. It is characterized by glucose intolerance of variable degrees with the beginning or first recognition of pregnancy. It affects 14% of pregnancies worldwide, and it undergoes continuous changes in the diagnostic criteria, ethnicity and the population studied.

There is an increasing prevalence of diabetes mellitus, and its major metabolic disorder caused by the insulin secretion defect or insulin action defect resulting from a defect in insulin secretion, insulin action, or both. As a result, it will lead to chronic hyperglycemia associated with carbohydrates, protein, and fat disturbance.

In spite of the fact that the reason for gestational diabetes mellitus is still not fully understood, it is proposed that human placental lactogen has growth hormone-like actions, and that it causes lipolysis and thus increases the levels of circulating fatty acids that repress the action of insulin and cause insulin resistance in pregnant females which appear to play a crucial role in the pathogenesis of gestational diabetes mellitus.

Eligibility criteria: Inclusion Criteria:

1. They were maternally aged between 20 and 35 years.
2. The gestational age ranged from between 24 and 36 weeks.
3. Their BMI didn't exceed 30 kg/m2.
4. A singleton live fetus and not under stressful event.

Exclusion Criteria

1. They had high-risk pregnancies.
2. Bad obstetric situations.
3. Diseases that could interfere with participation.
4. Smoking.
5. Oral sedative administration.

Primary outcomes:
measure: Change in The Oral Glucose Tolerance Test.
timeFrame: Change from Baseline Oral Glucose Tolerance Test at one month
measure: Change in The Hemoglobin A1C Test.
timeFrame: Change from Baseline Hemoglobin A1C Test at one month
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: The Outpatient Clinics, Faculty of Physical Therapy Kafrelsheikh University.
city: Cairo
country: Egypt
facility: The Outpatient Clinics, Faculty of Physical Therapy Kafrelsheikh University.
Study officials:
References:
Clinical trial NCT04409964: the Effect of Opioid-free General Anesthesia
Official title: the Effect of Opioid-free General Anesthesia on the Recovery Quality After Gynecological Laparoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gynecologic Disease
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
First posted: 2020-06-01
Enrollment: 78
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is performed to investigate the effect of opioid-free general anesthesia on the recovery quality after gynecological laparoscopy.

Detailed description: The quality of recovery after the surgery is assessed using the QoR 40. In addition, the various kinds of cytokine are assessed for the ancillary study.

Eligibility criteria: Inclusion Criteria:

* patient scheduled for gynecological laparoscopic surgery

Exclusion Criteria:

1. refusal to participate in this study
2. emergent surgery
3. chronic pain requiring for pain killer
4. psychiatric disease
5. preoperative bradycardia or hypotension
6. allergy or history of the adverse effect to study drug
7. pregnancy or lactation

Primary outcomes:
measure: the quality of recovery
timeFrame: at 24 hour after the completion of surgery
Secondary outcomes:
measure: cytokine
timeFrame: during surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St.Mary's Hospital
state: Seocho-gu
city: Seoul
country: Korea, Republic of
facility: Seoul St.Mary's Hospital
state: Seocho-gu
Study officials:
affiliation: Seoul St. Mary's Hospital
name: Youngeun Moon, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Song JY, Choi H, Chae M, Ko J, Moon YE. The effect of opioid-free anesthesia on the quality of recovery after gynecological laparoscopy: study protocol for a prospective randomized controlled trial. Trials. 2021 Mar 12;22(1):207. doi: 10.1186/s13063-021-05166-z.
Clinical trial NCT00589264: Zinc and Biobehavioral Development in Early Childhood
Official title: Zinc and Biobehavioral Development in Early Childhood
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Development
Keywords: zinc
iron
child development
visual attention
Peru
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: Instituto de Investigacion Nutricional, Peru
name: University of Kansas
name: University of Chicago
First posted: 2008-01-09
Enrollment: 251
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Zinc is necessary for growth and development, including the central nervous system, and zinc deficiency which is common in resource-poor settings, may adversely affect social, behavorial, cognitive and sensorimotor development. The project, located in Lima Peru, utilizes an experimental model in which children receive 10 mg supplemental zinc (or not) daily along with 10 mg iron and 1/2 mg copper from 6 months of age to 18 months of age. Beginning at 6 months of age, and at 9, 12, and 18 months, children are evaluated in multiples aspects of development. Children are also followed for their diet, growth, and health status. We hypothesize that children in this setting in which the diet is low in zinc who receive supplemental zinc will have better information processing skills, sensorimotor and behavioral development than their counterparts who do not receive supplemental zinc.


Eligibility criteria: Inclusion Criteria:

* Born at term of non-low birth weight
* Free of major malformations, genetic abnormalities or health problems associated with developmental delays
* Planning to remain in study area for one year
* In good general health

Exclusion Criteria:

* Low birth weight
* Non-term delivery
* Vision or hearing problems
* Anemia

Primary outcomes:
measure: cognitive development(visual attention, executive processing, vigilance)
timeFrame: 6, 9, 12, and 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lima
country: Peru
facility: Instituto de Investigacion Nutricional
Study officials:
affiliation: Johns Hopkins Bloomberg SPH
name: Laura E Caulfield, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Colombo J, Zavaleta N, Kannass KN, Lazarte F, Albornoz C, Kapa LL, Caulfield LE. Zinc supplementation sustained normative neurodevelopment in a randomized, controlled trial of Peruvian infants aged 6-18 months. J Nutr. 2014 Aug;144(8):1298-305. doi: 10.3945/jn.113.189365. Epub 2014 May 21.
Clinical trial NCT00617864: The Effect of Human Albumin Infusion on VEGF Levels in Women at Risk for Ovarian Hyperstimulation Syndrome
Official title: The Effect of Human Albumin Infusion on VEGF Levels in Women at Risk for Ovarian Hyperstimulation Syndrome.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Ovarian Hyperstimulation Syndrome
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2008-02-18
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This research study was designed to look at the effect of human albumin transfusion on circulating levels of Vascular Endothelial Derived Growth Factor (VEGF), a protein that is believed to be responsible for the syndrome of ovarian hyperstimulation. Patients have been asked to participate because they are identified as at risk for the Ovarian Hyperstimulation Syndrome (OHSS), a potentially serious complication of in vitro fertilization. It has been established that the onset of OHSS may be preventable by the infusion of albumin at the time of egg retrieval; however, we do not know by what mechanism albumin works. As we know the pathogenesis of OHSS is related to VEGF released from the ovaries, we believe human albumin may serve to "bind up" this VEGF and prevent it from causing its harmful effects. The purpose of this study is to evaluate the effect of albumin infusion on blood and urine VEGF levels in these patients.


Eligibility criteria: Inclusion Criteria:

* Infertile patients undergoing in vitro fertilization with or without ICSI
* Estradiol \> 3000 pg/mL at the time of hCG administration
* \>/= 20 follicles seen during ultrasound monitoring
* Patients with polycystic ovarian syndrome

Exclusion Criteria:

* Patients with only one ovary
* Patients with medical contraindication to human albumin (hypersensitivity, hypervolemia, cardiac insufficiency, hypertension, esophageal varices, pulmonary edema, severe anemia, renal failure)

Primary outcomes:
measure: Serum VEGF levels
timeFrame: Time surrounding egg retrieval
Secondary outcomes:
measure: Urine VEGF levels
timeFrame: Time surrounding egg retrieval
measure: Pregnancy
timeFrame: Time surrounding egg retrieval
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Fertility Center
state: Connecticut
Study officials:
affiliation: Yale University
name: Pasquale Patrizio, MD, MBE, HCLD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03722264: An Evaluation of Protective Effects of OpalSeal™ Against Early Dental Decay in Orthodontic Patients
Official title: An Evaluation of Protective Effects of OpalSeal™ Against Early Dental Decay in Orthodontic Patients. A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cavities of Teeth
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2018-10-26
Enrollment: 12
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Participants have at least two teeth planned for extraction on either side of the mouth. The study will use a split-mouth design with random assignments for intervention (OpalSeal) on one tooth.
Primary purpose: PREVENTION

Brief summary: Fluoride is very effective in preventing dental decay (cavities) when applied in the form of a varnish on tooth surfaces. The purpose of this study is to verify if fluoride-releasing primer (OpalSeal) offers more protection against early dental decay (cavity) compared to conventional primer (Transbond XT) during treatment with braces.

Detailed description: Primers are a type of 'glue' routinely used in orthodontics to attach brackets (metallic components) to the teeth. OpalSeal is a fluoride-releasing primer that has the potential to reduce cavities in patients receiving braces.

Orthodontic patients are at particular risk of developing two types of early carious lesions (decay):

1. Around the brackets called White Spot Lesions and
2. Along the sides of the teeth after slenderization procedure called inter-proximal reduction (IPR).

Our research questions are:

1. Can OpalSeal offer protection against white spot lesions (WSL) around the brackets?
2. Can OpalSeal offer protection against decay on the sides of teeth following IPR?

Eligibility criteria: Inclusion Criteria:

* Patients age 10 and older seeking treatment at the VCU Orthodontics Clinic who require extraction of at least 2 teeth for orthodontic purposes
* Such teeth should be free of any developmental defects

Exclusion Criteria:

* Patients under 10 years of age
* Patients with defective teeth
* Those who cannot provide consent/assent OR not able to follow research protocols
* Protected population (prisoners)

Primary outcomes:
measure: Loss of Mineral Density in the Enamel
timeFrame: Time from initial bonding to extraction (max 90 days)
Secondary outcomes:
measure: Surface Topography and Hardness
timeFrame: Time from initial bonding to extraction (max 90 days)
measure: Retention of OpalSeal
timeFrame: Time from initial bonding to extraction (max 90 days)
Other outcomes:
Locations:
city: Richmond
country: United States
facility: School of Dentistry, Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Parthasarathy Madurantakam, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01604564: Registry With Information About Colitis Ulcerosa and Familial Adenomatous Polyposis Patients
Official title: KOPOF Registry (Patients Characteristics, Operative Data, Postoperative Outcome, Functional Postoperative Recovery ) of Patients in Which a Pouch Has Been Created Due to Colitis Ulcerosa (CU) or Familial Adenomatous Polyposis(FAP)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colitis,Ulcerative
Adenomatous Polyposis Coli
Reservoir, Ileoanal
Keywords: Registry
Colitis Ulcerosa (CU)
Familial Adenomatous Polyposis(FAP)
IPAA
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2012-05-23
Enrollment: 207
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Colitis Ulcerosa or Familial Adenomatous Polyposis Patients who have undergone a restorative proctocolectomy with creation of an ileoanal pouche

Brief summary: The purpose of this registry is to collect information about patients in which a pouch has been created to improve in the future the quality of the surgery of the pouch.

Detailed description: To improve the quality of the surgery of the pouch created in CU and FAP patients, the following information will be collected: Patients Characteristics, Operative Data, Postoperative Outcome and Functional Postoperative Recovery.

Eligibility criteria: Inclusion Criteria:

* Colitis Ulcerosa or Familial Adenomatous Polyposis Patients With IPAA

Exclusion Criteria:

* No

Primary outcomes:
measure: Evaluation of postoperatieve recovery
timeFrame: 1 YEAR
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Clinics Gasthuisberg
state: Flemish Brabant
Study officials:
affiliation: University Clinics Gasthuisberg Department of Abdominal Surgery
name: André JL D'Hoore, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05119764: Manual Lymphatic Drainage Before and After Total Knee Replacement, a Single-center Observer-blinded Randomized Controlled Trial
Official title: Manual Lymphatic Drainage Before and After Total Knee Replacement, a Single-center Observer-blinded Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Knee Arthroplasty
Manual Lymphatic Drainage
MLD
Rehabilitation
Knee Osteoarthritis
Lead sponsor: Bezirkskrankenhaus St. Johann in Tirol
Sponsor class: OTHER
Collaborators: name: Bezirkskrankenhaus St. Johann in Tirol
First posted: 2021-11-15
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial with three treatment groups, two intervention groups and one control group
Primary purpose: TREATMENT

Brief summary: The aim of this observer-blinded randomized controlled trial is the evaluation of the influence of manual lymphatic drainage (MLD) on the outcome of patients receiving total knee replacement (TKA).


Eligibility criteria: Inclusion Criteria:

* Total Knee Arthroplasty (TKA)

Exclusion Criteria:

* Venous insufficiency
* BMI \> 38
* Vascular disease

Primary outcomes:
measure: Volume
timeFrame: Change in swelling weeks before the operation to one year after the operation
measure: Function
timeFrame: Change in ROM weeks before the operation to one year after the operation
measure: Knee Pain
timeFrame: Change in pain weeks before the operation to one year after the operation
Secondary outcomes:
measure: Subjective patient reported outcome
timeFrame: Before the operation, five days after the operation and one year after the operation
Other outcomes:
Locations:
city: Sankt Johann In Tirol
country: Austria
facility: BKH St. Johann in Tirol
state: Tyrol
Study officials:
References: