louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06484634: Role of Low-Molecular-Weight Heparin in Unexplained Recurrent Pregnancy Loss
Official title: Role of Low-Molecular-Weight Heparin in Unexplained Recurrent Pregnancy Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Loss
Lead sponsor: RESnTEC, Institute of Research
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 175
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Using low-molecular-weight heparin (LMWH), outcomes such as live birth rate and the occurrence of pregnancy complications are some of the variables reported in some studies, with varying degrees of success. The present study aimed to compare the role of LMWH in unexplained recurrent pregnancy loss.


Eligibility criteria: Inclusion Criteria:

* Pregnant females between 18 and 44 years of age
* Gestational age above 8 weeks
* A history of ≥3 consecutive first trimester pregnancy losses

Exclusion Criteria:

* Patients with systemic lupus erythematosus
* Positive IgG and IgM anticardiolipin antibodies
* Positive for thrombophilia screening
* Any platelet function abnormality or a previous thromboembolic event requiring anticoagulant therapy (including heparin, aspirin or warfarin)
* Sensitive to acetylsalicylic acid, heparin, or warfarin
* Patients with any genetic, anatomical, or hormonal cause of recurrent pregnancy loss

Primary outcomes:
measure: Efficacy of Low-Molecular-Weight Heparin
timeFrame: 32 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Dera Ghazi Khan
country: Pakistan
facility: DG Khan Hospital
state: Punjab
Study officials:
References:
Clinical trial NCT02461134: Clinical Study to Investigate the Biological Activity, Safety, Tolerability, and Pharmacokinetics of Ponesimod in Subjects With Symptomatic Chronic GVHD
Official title: A Phase 2, Open-label, Single-arm, Intra-subject Dose-escalation Study to Investigate the Biological Activity, Safety, Tolerability, and Pharmacokinetics of Ponesimod in Subjects With Symptomatic Moderate or Severe Chronic GVHD Inadequately Responding to First or Second Line Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Chronic Graft Versus Host Disease
Keywords: GVHD
ponesimod
Lead sponsor: Actelion
Sponsor class: INDUSTRY
First posted: 2015-06-03
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Chronic graft versus host diseasre (GVHD) is a serious reaction that might occur in a person (the host) who has received cells or organs (graft) from another person because the graft attacks the host's cells. Currently there are no approved therapies for chronic GVHD in the USA, and patients with chroninc GVHD are treated with immunosuppressant drugs. T-lymphocytes (a type of white blood cells) are likely to play a role in the development of chronic GVHD. Due to the capacity of ponesimod to block the traffic of T-lymphocytes, ponesimod may be a new therapeutic approach to treat chroninc GVHD.

The main objective of this study is to assess the effectiveness and safety of several doses of ponesimod in subjects with chronic GVHD who did not respond to standard available treatments.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* Symptomatic moderate or severe chronic GVHD patients in need of a change of systemic immunosuppressant (IS) therapy
* Women of child bearing potential must have a negative pregnancy test and use reliable methods of contraception

Exclusion Criteria:

* Clinically significant medical conditions including active or uncontrolled infections, new or recurrent malignancy, serious cardiac, pulmonary, or renal disease, and uncontrolled diabetes.
* Karnofsky Performance Score \< 60.
* Immunosuppressant therapies other than allowed background therapy
* Anti-arrhythmic and heart rate lowering drugs.
* Any other circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol

Primary outcomes:
measure: Change in Peripheral Absolute Lymphocyte Count From Baseline to Week 4, 8 and 12
timeFrame: From baseline to Week 12
Secondary outcomes:
measure: Incident Rate of Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: From the first study drug intake up to 30 days after last study drug intake (Week 24)
Other outcomes:
measure: Assessment of a Partial or Complete Overall Response at Week 24
timeFrame: At Week 24
Locations:
Study officials:
affiliation: Actelion
name: Daniele D'Ambrosio, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05417334: Effect of Radiofrequency in the Treatment of de Novo Dyspareunia at 4 to 9 Months Postpartum.
Official title: Effect of Radiofrequency in the Treatment of de Novo Dyspareunia at 4 to 9 Months Postpartum: Randomised Prospective Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dyspareunia
Keywords: dyspareunia
radiofrequency
postpartum pain
perineal massage
episiotomy
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2022-06-14
Enrollment: 110
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates if the application of resistive capacitive monopolar radiofrequency therapy associated with Thiele massage is effective when treating de novo dyspareunia at 4 to 9 months postpartum.

Detailed description: Dyspareunia is a type of genito-pelvic pain (GPP) that takes place during vaginal penetration at some point in sexual intercourse. It greatly affects quality of life as well as psychological and sexual wellbeing. A delivery with episiotomy, perineal tearing or labor dystocia using forceps or vacuum, are risk factors that contribute to the appearance of de novo dyspareunia with a prevalence of 17-45% at 6 months postpartum.

There is no evidence in the scientific literature of the effect of radiofrequency is this group of patients, however there is a clinical trial that describes the effect in scar tissue although not in the perineum. It is for all of the above that the following project is proposed, to evaluate the effect of RF in perineal healing and vaginal trigger points caused as a consequence of GPP.

The main objective of this study is to evaluate the role that radiofrequency (RF) plays in reducing the level of pain in de novo dyspareunia in postpartum women that persists from 4 to 9 months.

Eligibility criteria: Inclusion Criteria:

* 4-9 postpartum
* de novo dyspareunia after delivery
* obstetric injury
* Grant informed consent

Exclusion Criteria:

* radiofrequency contraindications (pacemaker, active infection or pregnancy)
* cesarean section
* dyspareunia previous to labour
* previous vulvo-vaginal pathology
* patients with postpartum depression
* patients with a pelvic region oncological history

Primary outcomes:
measure: Change of the baseline Level of pain during penetration and after 5 sessions
timeFrame: Baseline and after 7 weeks
Secondary outcomes:
measure: Change of the baseline Sexual function and after 5 sessions
timeFrame: Baseline and after 7 weeks
measure: Change of the baseline muscle pain points and after 5 sessions
timeFrame: Baseline and after 7 weeks
measure: Change in Pelvic floor dysfunctions in the baseline assesment and after 5 sessions
timeFrame: Baseline and after 7 weeks
measure: Change of the baseline affection on the quality of life and after 5 sessions
timeFrame: Baseline and after 7 weeks
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic Barcelona
Study officials:
References:
Clinical trial NCT01553734: Does Azithromycin Cause QT Prolongation in Hospitalized Patients With Severe Community Acquired Pneumonia?
Official title: Does Azithromycin Cause QT Prolongation in Hospitalized Patients With Severe Community Acquired Pneumonia?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumonia
Keywords: QT prolongation
Azithromycin
macrolide
pneumonia
ECG changes
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2012-03-14
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized with severe community aquired pneumonia treated with azithromycin

Brief summary: The macrolide group of antibiotics can cause QT prolongation, and endanger the patient with life threatening arrythmias. QT prolongation caused by Azythromycin, a relatively new macrolide, is extremely rare, and was not reported in clinical trials. Our hypothesis is that patients hospitalized with severe community acquired pneumonia, usually with multiple comorbid conditions will have a higher rate of QT prolongation, compared to the clinical trials published

Detailed description: Patients hospitalized with community aquired pneumonia will have their corrected QT measured daily during antibiotic therapy. Concomittant medications and electrolyte abnormalities that cause prolonged QT will be recorded

Eligibility criteria: Inclusion Criteria:

* Severe community acquired pneumonia
* treated with azithromycin
* age over 18 years

Exclusion Criteria:

* Azithromycin initiated before hospitalization
* technically undecipherable ECG
* Permanent pacemaker

Primary outcomes:
measure: Corrected QT segment of ECG
timeFrame: Daily, at estimated peak antibiotic level, during index hospitalization
Secondary outcomes:
Other outcomes:
Locations:
city: Afula
country: Israel
facility: HaEmek Medical Center
Study officials:
affiliation: Haemek Medical Center, Afula, Israel
name: Lee H Goldstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00629434: A Comparison of Diabetes Group Education as Administered Through Telemedicine Versus as Administered in Person
Official title: A Comparison of Diabetes Group Education as Administered Through Telemedicine Versus as Administered in Person
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Diabetes Education
Telemedicine
Lead sponsor: State University of New York - Upstate Medical University
Sponsor class: OTHER
First posted: 2008-03-06
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study compares group diabetes education in-person versus via telemedicine

Detailed description: Diabetes education is important in the treatment of the person with diabetes. A diabetes self-management education program not only educates the patient and his/her family to the basics of diabetes care but also integrates diabetes care into daily life while providing coping skills to adjust to this chronic illness. Unfortunately, comprehensive diabetes care is not available to all persons with diabetes. One obstacle to the provision of comprehensive diabetes care is the unavailability of a diabetes treatment center. many people with diabetes live too far or do not have the transportation to be able to attend education programs that met national standards. We have shown that telemedicine is an effective means to provide comprehensive 1:1 individualized diabetes education to persons with diabetes. We now propose to test the hypothesis that diabetes groups education classes can be provided effectively through telemedicine technology to individuals living in rural areas. Patients with diabetes will received diabetes education via teleconferencing from our Joslin Diabetes center. The participants will be assessed before and after diabetes education via telemedicine using measures of glycemia (A1c) and assessments of patient satisfaction, emotional well being, and behavioral change and compared to results from participants attending our diabetes education classes in-person.

Eligibility criteria: Inclusion Criteria:

* Type 1 or type 2 diabetes mellitus
* age \> 18 years

Exclusion Criteria:

* Profound vision loss
* Severe hearing impairment

Primary outcomes:
measure: A1c
timeFrame: baseline, 3 mo post intervention, 6 mo post intervention
Secondary outcomes:
measure: PAID scale
timeFrame: baseline, 3 and 6 months post intervention
measure: Diabetes Treatment Satisfaction Questionnaire
timeFrame: Baseline, 3 and 6 months post intervention
Other outcomes:
Locations:
city: Syracuse
country: United States
facility: Joslin Diabetes Center Affiliate at SUNY Upstate Medical University
state: New York
Study officials:
References:
Clinical trial NCT03680534: 3D Analysis of Root Canal Conformation
Official title: Three-dimensional Analysis of the Root Canal Preparation With Reciproc Blue, WaveOne Gold and XP EndoShaper
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endodontic Disease
Root Canal Infection
Keywords: root canal preparation
single-file preparation techniques
3D reconstruction
Lead sponsor: Institucion Universitaria Colegios de Colombia
Sponsor class: OTHER
First posted: 2018-09-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim To evaluate in vivo the shaping ability of the canal with 3 different single-file systems: Reciproc Blue, WaveOne Gold and XP Endo-Shaper, using cone beam computed tomography and 3D reconstructions to measure canal volume increase, centering ability of the instruments and canal transportation in human premolars in vivo.

Methodology Thirty human lower premolars were randomly divided into three groups, in which root canals were prepared using one of these single-file systems: Reciproc Blue, WaveOne Gold, and XP EndoShaper. Root canals were scanned before and after root canal preparation by using CBCT and 3D reconstruction was carried out to evaluate canal volume increase, centering ability of the instrument and canal transportation for each group. Statistical analysis was made for each variable to determine statistically significant differences between groups.


Eligibility criteria: Inclusion Criteria:

1. 18-30 years old
2. healthy conditions
3. not medicated with any type of drug
4. non-smoking patients
5. lower premolars indicated for extraction due to orthodontic reasons
6. lower premolar with more than one root canal

Exclusion Criteria:

1. Not willing to participate
2. Pregnant women
3. lower premolars with previous root canal therapy
4. lower premolars with

Primary outcomes:
measure: Root canal volume increase in cubic millimetres after root canal preparation by using the volume command in the Rhinoceros 5.0 software
timeFrame: One day
measure: Root canal transportation after preparation assessed by superimposing three-dimensional reconstruction images of pre- and post-preparation
timeFrame: One day
measure: Centring ability of the instruments used to prepare the root canal assessed by determining if canal was enlarged equally to each of its walls
timeFrame: One day
Secondary outcomes:
Other outcomes:
Locations:
city: Bogota
country: Colombia
facility: Facultad de Odontologia, Unicoc
Study officials:
affiliation: Institucion Universitaria Colegios de Colombia
name: Javier Caviedes-Bucheli
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01682434: Wavefront-guided LASIK for Correction of Myopia
Official title: Wavefront-guided LASIK for Correction of Myopia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Myopia
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
First posted: 2012-09-11
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Laser in situ keratomileusis is a successful procedure for the treatment of low to moderate myopia.

Advances over the last decade have allowed LASIK to also correct higher order wavefront aberrations. In low myopia, there seem to be a minor effect of such wavefront-guided treatment. However, it remains to be established whether there is a beneficial effect in higher degrees of myopia.

The study aims to determine whether myopic subjects (-6 to -10 diopters) with higher-than-average preoperative higher-order aberrations have benefit of wavefront-guided treatment. Subjects are randomized to wavefront-guided treatment in one eye, and conventional treatment in the other.


Eligibility criteria: Inclusion Criteria:

* Age 20 to 50 years
* No known ocular or systemic disease
* Not pregnant or breastfeeding
* Myopia between -6.0 and -10.0 diopters
* Astigmatism below 2.0 diopters
* Difference of less than 1.0 diopters in spherical equivalent between eyes
* Normal corneal topography
* Corneal thickness sufficient for planned treatment

Exclusion Criteria:

* Patients that do not fulfill inclusion criteria
* Insufficient quality of ocular wavefront measurement

Primary outcomes:
measure: Visual acuity
timeFrame: 12 months
Secondary outcomes:
measure: Ocular higher order aberrations
timeFrame: 12 months
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Ophthalmology, Aarhus University Hospital
Study officials:
affiliation: Aarhus University Hospital
name: Anders Ivarsen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01402934: Pulse Pressure Variation in Spontaneously Breathing Patients
Official title: The Ability of Pulse Pressure Variation to Predict Fluid Responsiveness in Spontaneously Breathing Patients Undergoing Thoracic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulse Pressure Variation
Spontaneously Breathing
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2011-07-26
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators hypothesized that pulse pressure variation (PPV) could predict fluid responsiveness in spontaneously breathing patients undergoing anesthesia induction.

Detailed description: Pulse pressure variation (PPV) is known to be a dynamic indicator to predict fluid responsiveness in mechanically ventilating patients. PPV is generated by cardiopulmonary interaction with respiratory cycles. In spontaneous breathing, the cardiopulmonary interaction may lead to PPV by inverted manner. In this study, the investigators will evaluate the ability of PPV to predict fluid responsiveness in spontaneously breathing patients. Before induction of anesthesia, radial artery cannulation is performed, and FloTrac/Vigileo (Edwards Lifesciences Corp., Irvine, USA) system is connected. And then, the investigators will measure baseline data including invasive blood pressure, pulse pressure, cardiac index, stroke volume variation in two different conditions: during tidal spontaneous breathing and during forced spontaneous breathing. All hemodynamic measurement will be repeated after infusion of fluid using 6mL/kg of hydroxyethyl starch solution (Voluven), and will be averaged over 3 minutes. Patients whose cardiac index increased by \>15% to fluid infusion is defined as responders. The investigators will compare the hemodynamic parameters between responders and non-responders. To evaluate the ability to predict volume responsiveness, receiver operating characteristics curves of the PPV will be calculated.

Eligibility criteria: Inclusion Criteria:

* patients undergoing thoracic surgery

Exclusion Criteria:

* preoperative arrhythmia
* left ventricular ejection fraction \<40%
* intra-cardiac valve disease
* intra-cardiac shunt
* pulmonary artery hypertension
* severe peripheral vascular obstructive disease
* decreased pulmonary function

Primary outcomes:
measure: pulse pressure variation
timeFrame: three respiratory cycles, an expected average of 30 seconds
Secondary outcomes:
measure: hemodynamic parameters
timeFrame: before and after fluid loading, 1 mimute
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT04077034: Effect of Probiotic Formula DE111® on Immune System in Preschool Children
Official title: A Randomized, Parallel, Double Blind, Placebo Controlled Clinical Study Evaluating the Effect of Probiotic Formula on Immune System in Preschool Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immune System Support
Lead sponsor: Deerland Enzymes
Sponsor class: INDUSTRY
Collaborators: name: Vizera d.o.o.
name: University of Ljubljana
First posted: 2019-09-04
Enrollment: 102
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Healthy preschool children will be recruited, gastrointestinal infection and respiratory infection symptoms will be followed during the 8-week treatment and 4-week follow-up period, to evaluate the effect of the used probiotic formula on immune system in comparison to the group using placebo.


Eligibility criteria: Inclusion Criteria:

* signed informed consent by at least one parent or legal guardian
* children aged 2 to 6 years
* attending or about to start attending day-care

Exclusion Criteria:

* body weight at birth \<2500g
* gestational age \<37 weeks
* severe chronic illness
* regular use of medication
* immunodeficiency
* parent or legal guardian not able to understand and comply with requirements of the study

Primary outcomes:
measure: The incidence of gastrointestinal and/or respiratory infections for experimental group compared to control group
timeFrame: 12-week study period (consisting of 8-week treatment plus 4-week follow-up)
measure: The incidence of adverse events occuring in the experimental group compared to control group
timeFrame: 12-week study period (consisting of 8-week treatment plus 4-week follow-up)
Secondary outcomes:
Other outcomes:
Locations:
city: Laško
country: Slovenia
facility: Health center Laško
city: Maribor
country: Slovenia
facility: Pediatrija Krebs
city: Maribor
country: Slovenia
facility: Pediatrinja d.o.o.
city: Maribor
country: Slovenia
facility: Zasebna otroska in solska ambulanta
city: Šempeter Pri Gorici
country: Slovenia
facility: Health Center Nova Gorica
Study officials:
affiliation: Health Center Nova Gorica
name: Lilijana Kocijancic Besednjak, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: