louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01796080: The Effect of Simulated Obstructive Apnoea and Hypopnoea on Heart Rhythm in Patients With Paroxysmal Atrial Fibrillation
Official title: The Effect of Simulated Obstructive Apnoea and Hypopnoea on Heart Rhythm in Patients With Paroxysmal Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patients With Paroxysmal Atrial Fibrillation
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2013-02-21
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: In this randomised controlled cross-over study we will investigate whether intrathoracic pressure changes induced by simulated obstructive apnoea and hypopnoea trigger premature supraventricular and ventricular contractions as well as atrial fibrillation in patients with paroxysmal atrial fibrillation.


Eligibility criteria: Inclusion criteria:

* Age 18-75 years
* History of ECG-documented paroxysmal atrial fibrillation within the last 12 months and currently in sinus rhythm
* Informed consent

Exclusion criteria:

* Mental or physical disability precluding informed consent or compliance with the protocol
* Amiodarone or Dronedarone medication
* Previous radiofrequency ablation for atrial fibrillation
* Severe structural heart disease

Primary outcomes:
measure: Number of subjects with premature myocardial contractions and/or atrial fibrillation
timeFrame: 20 seconds
Secondary outcomes:
measure: ECG-derived myocardial de- and repolarization times
timeFrame: 20 seconds
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Division of Pneumology
state: ZH
Study officials:
affiliation: University Hospital Zurich, Division of Pneumology
name: Malcolm Kohler, Prof MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06044129: A Novel Approach Integrating Magnetic Resonance Imaging (MRI) Data and Artificial Intelligence for Predicting the Success Rate of Vaginal Delivery in Pregnant Women
Official title: A Novel Approach Integrating Magnetic Resonance Imaging (MRI) Data and Artificial Intelligence for Predicting the Success Rate of Vaginal Delivery in Pregnant Women
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Vaginal Delivery
Lead sponsor: Second Affiliated Hospital of Wenzhou Medical University
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Full-term single live pregnant women who gave birth in the Department of Obstetrics of the Second Affiliated Hospital of Wenzhou Medical University from January 1, 2024 to December 31, 2026 were selected as the study population

Brief summary: The aim of this study was to use MRI imaging to accurately scan the pregnant woman's pelvis and fetal skull, build a 3D model of them, and combine with artificial intelligence to develop an accurate tool to predict the success rate of vaginal delivery.


Eligibility criteria: Inclusion Criteria:

* Full-term.
* Single fetus, head first.
* Pregnant women have vaginal couvade wishes.
* Complete clinical data of pregnant women.

Exclusion Criteria:

* Pregnancy with serious medical and surgical diseases.
* Abnormal fetal position (such as transverse, breech, etc.).
* Twin or multiple pregnancies.
* Vaginal couvade contraindications such as placenta previa.

Primary outcomes:
measure: The mode of delivery
timeFrame: during delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: department of obstetrics of Second Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
References:
Clinical trial NCT03254680: Turmeric as Treatment in Epilepsy
Official title: Turmeric as Treatment in Epilepsy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Epilepsy
Dravet Syndrome
Lennox-Gastaut Syndrome
Tuberous Sclerosis
Focal Seizures
Keywords: Turmeric Oil
antiseizure medications
ar-turmerone
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2017-08-18
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a single center open-label pilot clinical trial of patients 1-70 years of age with greater than 6 seizures per month diagnosed with Dravet Syndrome, Lennox-Gastaut Syndrome, Tuberous Sclerosis, or focal seizures. Twenty patients will be enrolled and treated with a stable dose of orally administered turmeric oil daily for 3 months. Patients and caregivers will be asked to keep a seizure diary logging all clinical events during the course of the study. Serum comprehensive metabolic panel, complete blood count with differential, and antiseizure medication levels, will be monitored at baseline, 1.5 months, and at the end of 3 months.


Eligibility criteria: Inclusion Criteria:

* Patients with greater than greater than six seizures per month diagnosed with Dravet Syndrome, Lennox-Gastaut Syndrome, Tuberous Sclerosis, or focal seizures followed at NYU CEC.

Exclusion Criteria:

* Patients expected to have changes to any medications or supplements during study period
* exposure to any investigational agent in the month prior to study entry
* pregnant or breast feeding women, positive pregnancy test
* history of non-compliance
* known drug or alcohol dependence
* known baseline hematologic
* liver function
* renal function
* absorption
* absorption

Primary outcomes:
measure: Number of epilepsy patients enrolled in study
timeFrame: 3 months
Secondary outcomes:
measure: Number of epilepsy seizures post epilepsy treatment with turmeric
timeFrame: 3 months
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Manisha Holmes, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06586580: Treatment of Metastatic Melanoma with Lenvatinib + Anti-PD1
Official title: Le Traitement Par Lenvatinib + Anti-PD1 Du Mélanome Métastatique
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Melanoma
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Metastatic melanoma (stage III non operable or stage IV according to AJCC)

Brief summary: The hypothesis is that treatment with Lenvatinib + Pembrolizumab is less effective in real life than in clinical trials. In fact, an objective response rate \&lt; 20% and a worse tolerability of the treatment in real life with ≥50% of severe toxicities are expected.


Eligibility criteria: Inclusion Criteria:

* Metastatic melanoma (stage III non operable or stage IV according to American Joint Committee on Cancer staging rules) refractory to immunotherapy (≥ 2nd treatment line after minimum a failure of immunotherapy)

Exclusion Criteria:

* Uveal melanoma

Primary outcomes:
measure: Objective response rate
timeFrame: Month 18
Secondary outcomes:
measure: Progression-free survival
timeFrame: Month 18
measure: Overall survival
timeFrame: Month 18
measure: Frequencies of severe toxicities leading to treatment interruption
timeFrame: Month 18
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU de Besançon
Study officials:
References:
Clinical trial NCT03917680: Evaluation of New Markers in Type 3 Angioedema
Official title: Evaluation of New Markers (FXII and Videocapillaroscopy) in Type 3 Angioedema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Angio Edema
Lead sponsor: Brugmann University Hospital
Sponsor class: OTHER
First posted: 2019-04-17
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Angioedema is a common condition, with multiple etiologies.

Type 3 angioedema is caused by an increase in kininogenase activity responsible for an increased production of bradykinin. In some cases, it may be associated with clotting factor 12 mutations. However, other genetic abnormalities remain to be identified.

Clinically, this angioedema type 3 is similar to types 1 and 2. The patient's vital prognosis is good if the diagnosis is made and if they have access to the appropriate treatment. Otherwise a significant morbidity is associated with it, hence the importance of being able to define a diagnostic marker.

Videocapillaroscopy might be able to highlight abnormalities in the microcirculation of patients with a clinical display of angioedema.

The purpose of this study is to highlight markers allowing to make an early diagnosis of angioedema. Functional analysis of factor XII in patients with symptoms of angioedema may be an interesting marker for diagnosis.

Microcirculation abnormalities will also be evaluated by videocapillaroscopy, which may be another indicator of the disease.


Eligibility criteria: Inclusion Criteria:

* Population of patients treated within the CHU Brugmann Hospital for an angioedema (and control group of healthy individuals)

Exclusion Criteria:

* None

Primary outcomes:
measure: Plasma concentration of Factor XII
timeFrame: 24 hours
measure: Presence of p.Thr328Lys mutation
timeFrame: 24 hours
measure: Videocapillaroscopy result
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: CHU Brugmann
Study officials:
affiliation: CHU Brugmann
name: Oumnia Mouna, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00641680: Rhinocort Aqua Versus Placebo and Fluticasone Propionate
Official title: A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-group, Phase IIIb Study to Assess the Efficacy, Safety & Product Attributes of Rhinocort Aqua(Budesonide) Versus Placebo and FluticasonePropionate as an Active Comparator in Patients 12yrs Age &Older With SeasonalAllergicRhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Seasonal Allergic Rhinitis
Keywords: Seasonal allergic rhinitis
Nasal symptoms
Congestion
Rhinorrhea
Sneeze
budesonide
Rhinocort AQUA
Fluticasone propionate
Flonase
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-03-24
Enrollment: 750
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare once daily treatment with Rhinocort against placebo and Fluticasone Propionate at reliving the nasal symptoms of seasonal allergic rhinitis.


Eligibility criteria: Inclusion Criteria:

* At least a 2 year documented history of seasonal allergic rhinitis
* who, in the opinion of the investigator,
* is a candidate for treatment with nasal steroids based on a history of either

  * a)inadequate control of symptoms with antihistamines, decongestants and/or immunotherapy, or
  * b) prior successful treatment with nasal steroids.
* A positive response to a skin prick test at Visit 1 or within the last 12 months for grass allergens that must be present in the subject's environment for the duration of the study.

Exclusion Criteria:

* Primary or secondary adrenal insufficiency
* Nasal candidiasis, rhinitis medicamentosa, acute or chronic sinusitis, influenza, upper respiratory tract infection or structural abnormalities of the nose (e.g., septal deviation, nasal polyps) symptomatic enough to cause significant nasal obstruction as judged by the investigator.
* A diagnosis of asthma requiring treatment as specifies in the protocol.

Primary outcomes:
measure: To compare once daily treatment with Rhinocort against placebo and at reliving the nasal symptoms of seasonal allergic rhinitis.
timeFrame: 2 weeks
Secondary outcomes:
measure: To compare once daily treatment with Rhinocort against Fluticasone Propionate at reliving the nasal symptoms of seasonal allergic rhinitis.
timeFrame: 2 weeks
measure: To compare once daily treatment with placebo against Fluticasone Propionate at reliving the nasal symptoms of seasonal allergic rhinitis.
timeFrame: 2 weeks
measure: Safety assessment via adverse events and clinical measurements.
timeFrame: 2 & 4 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Pharmaceutical Research, Dallas, USA
name: Michael E Ruff, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04294680: Opiate Sparing Versus Opiate Based Following Shoulder Arthroplasty
Official title: Prospective, Randomized, Controlled Trial of an Opiate Sparing Protocol Versus Standard Opiate-Based Protocol Following Shoulder Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Surgery
Lead sponsor: Campbell Clinic
Sponsor class: OTHER
First posted: 2020-03-04
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To investigate the difference between an opiate sparing pain management protocol versus a standard opiate-based protocol following shoulder arthroplasty in the ninety day postoperative period regarding visual analog scores and oral morphine equivalents.

Detailed description: This is a single center, investigator initiated, prospective, randomized, controlled trial conducted among patients who have given voluntary consent to participate. Participation will last until the completion of the twelve weeks standard of care follow up visit.

Eligibility criteria: Inclusion Criteria:

* Primary shoulder arthroplasty
* 18-85 years of age
* Body Mass Index greater than or equal to 45
* Willing and able to provide written informed consent
* Willing and able to cooperative in the required postoperative therapy
* Willing and able to complete scheduled follow-up evaluations
* Fluent in verbal and written English

Exclusion Criteria:

* Less than 18 years or over 85 years of age
* Unable to provide written informed consent, cooperate with postoperative therapy, or complete follow-up evaluations
* Known sensitivity, allergy, or intolerance to medications with protocols
* Renal disease as defined by active or impending dialysis within six months or kidney transplant
* Concomitant ipsilateral upper extremity injury or condition other than shoulder that compromises function
* Chronic pain syndrome
* Five consecutive days of opiate use with the previous ninety days
* Worker's compensation claim
* Women who are pregnant, planning to become to become pregnant, or breastfeeding

Primary outcomes:
measure: Visual Analog Score (VAS) at Week 2
timeFrame: postoperative day fourteen (two weeks)
Secondary outcomes:
measure: Number of Opioid Pain Pills Taken
timeFrame: Post-operative Day 1 through 12 weeks
Other outcomes:
Locations:
city: Memphis
country: United States
facility: Campbell Clinic
state: Tennessee
Study officials:
affiliation: Campbell Clinic
name: Tyler Brolin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04636580: Parental Affect in Dental Procedures
Official title: The Effect of Parents' Presence and Their Anxieties on Children's Dental Anxiety During Dental Procedures: Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behavior
Dental Anxiety
Keywords: Behaviour
Dental anxiety
Parental presence
Lead sponsor: Uşak University
Sponsor class: OTHER
First posted: 2020-11-19
Enrollment: 160
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Background: To evaluate the effect of the anxiety of a parent accompanying a child on the child's anxiety during treatment.

Methods: Parents of 160 patients (4-8 years old) were divided into two groups anxious and non-anxious. Each groups had separated two randomized subgroups that with/without parents accompanied their children. At the first visit, participating children were examined while the behavior of the child during the examination was evaluated by a single pediatric dentist according to their heart rates measured by a portable pulse oximeter and the data were recorded (objective data).Forty-two children with a score of 1 and 4 on the Frankel Scale were excluded. After the parents were divided into two groups, anxious and non-anxious, the groups were equally divided randomly and the parents accompanied their children during the treatment.

Patients were recalled after one week for the treatment visit. Both groups were evaluated using the basic behavior technique. Compomer fillings were performed on children with infiltration anesthesia. The children's heart rates were measured by a portable pulse oximeter during treatment. Finally, the children were asked to express how they felt about the treatment by pointing out one of the faces on the Wong-Baker Faces Scale (subjective data). The children also rated the experience on the Frankel scale administered by the same operator.


Eligibility criteria: Inclusion Criteria:

* mentally and physically healthy children with caries requiring anesthesia and no previous dental experience were selected for the study

Exclusion Criteria:

* children with a score of 1 and 4 on the Frankel Scale were excluded.

Primary outcomes:
measure: change in anxiety during the treatment according to the accompaniment of the anxious parent of the child
timeFrame: An average of 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Usak
country: Turkey
facility: Tuğba YIGIT
Study officials:
affiliation: Uşak University
name: Esra OZGOCMEN, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00145080: Comparison of Osteoporosis Disease Management Strategies (0000-039)
Official title: Evaluation of Strategies for Increasing Osteoporosis Screening and Treatment in a Managed Care Organization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2005-09-05
Enrollment: 4685
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to assess the impact of disease management interventions on bone mineral density screening rates and osteoporosis treatment rates in women age 50-64 years at high risk for osteoporosis.


Eligibility criteria: Inclusion Criteria:

* Members of the Harvard Pilgrim Health Plan

Exclusion Criteria:

* Individuals who are not members of the Harvard Pilgrim Health Plan

Primary outcomes:
measure: Bone mineral density screening rates
Secondary outcomes:
measure: Medications adoptions; Medications adherence
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Heyworth L, Kleinman K, Oddleifson S, Bernstein L, Frampton J, Lehrer M, Salvato K, Weiss TW, Simon SR, Connelly M. Comparison of interactive voice response, patient mailing, and mailed registry to encourage screening for osteoporosis: a randomized controlled trial. Osteoporos Int. 2014 May;25(5):1519-26. doi: 10.1007/s00198-014-2629-1. Epub 2014 Feb 25.
Clinical trial NCT01536080: Analysis of GERD Symptoms Using Gastroesophageal Reflux Impact Score Questionnaire for Quality of Life
Official title: Comparison of Risk Factors, GERD Symptoms and PPI Responses in the Reflux Esophagitis, Non-erosive Reflux Disease and Functional Heartburn Using GERD Impact Scale Questionnaire
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Reflux Esophagitis (RE)
Non-erosive Reflux Disease (NERD)
Functional Heartburn (FH)
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2012-02-20
Enrollment: 207
Sex: ALL
Minimum age (years): 16
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Even the patients complain GERD symptoms such as heartburn and acid regurgitation the final diagnosis could be reflux esophagitis (RE), non-erosive reflux disease (NERD) and even functional heartburn (FH).

Brief summary: Even the patients complain GERD symptoms such as heartburn and acid regurgitation the final diagnosis could be reflux esophagitis (RE), non-erosive reflux disease (NERD) and even functional heartburn (FH). In addition, the GERD symptoms are consisted of esophageal symptoms and extraesophageal symptoms. Thus it is necessary to use effective tool for the measurement of GERD symptoms and response of proton pump inhibitor in short time. Several questionnaires have been made for the assessment of GERD symptoms in recent years However, their screening tools do not include the impact of symptoms on everyday life and take a long time to complete the questionnaires. The GERD impact scale (GIS) questionnaire has been developed to compensate for this. It is a simple, one-page, questionnaire to communicate to the doctor the frequency of reflux symptoms and their effect on quality of life, recognizing that it might also prompt clinicians to make appropriate treatment for patients' symptoms. However, there was no report regarding comparison of the characteristics and response to PPI in RE, NERD and FH groups using GIS questionnaire so far.


Eligibility criteria: Inclusion Criteria:

* Adult Subjects (From 16 to 85 years old)
* The subjects with GERD symptom who received 8 week PPI therapy

Exclusion Criteria:

* Patients with a history of gastrointestinal surgery, Barrett's esophagus, esophageal motility disorder, duodenal ulcer, benign gastric ulcer or gastroduodenal cancer and systemic disease requiring chronic medication (except for hypertension and diabetes mellitus)
* Patients who took H2 blocker or a PPI to relieve these symptoms within 4 weeks

Primary outcomes:
measure: The GIS score at baseline
timeFrame: Before 8 weeks PPI treatment(baseline)
Secondary outcomes:
measure: Change of the GIS score from baseline
timeFrame: After 8 weeks PPI treatment
Other outcomes:
Locations:
city: Bundang-gu, Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
References: