louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02789202: Diammine Silver Fluoride in Arresting Enamel Caries Lesions on Babies' Occlusal Surfaces
Official title: Efficacy, Cost-efficacy and Parental Acceptability of Using Diammine Silver Fluoride in Arresting Enamel Caries Lesions on Babies' Occlusal Surfaces
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Caries
Keywords: dental caries
deciduous tooth
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2016-06-02
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to verify the actual possibility of using silver diammine fluoride (SDF) in arresting enamel caries lesions on occlusal surfaces of primary molars in babies. Besides, the cost-efficacy and also parental acceptability of using SDF will be evaluated. For this, 100 babies 1-3 years will be examined and treated in a mobile dental unit, which will temporarily be parked in public schools of Barueri, Sao Paulo, Brazil. The caries diagnosis will be conducted using the International Caries Detection and Assessment System (ICDAS). Babies with initial lesions will be randomized concerning the treatment in Group A (SDF) and Group B (fluoride varnish). Participants will be examined in the baseline and followed by 6, 12, 18 and 24 months. As primary outcome, caries progression into dentine will be considered. Acceptability reported by parents after treatments, the time and estimated money spent for treating will also be collected. Social and biological data that could be related to efficacy of techniques will be also collected. Multilevel analyses will be performed to check which technique will be most effective and possible factors associated to its efficacy. Discomfort, acceptability and costs will be compared between/among the approaches used to arrest enamel caries lesions.


Eligibility criteria: Inclusion Criteria:

* Babies 1 to 3 years;
* Babies with initial dental caries lesion.

Exclusion Criteria:

* Parents who do not consent.

Primary outcomes:
measure: Number of caries lesions which progressed to dentine
timeFrame: 24 months
Secondary outcomes:
measure: Parental acceptability to the treatment using a VAS scale
timeFrame: 12 months
Other outcomes:
measure: Direct and Indirect Costs of initial procedures and consequent interventions during 24 months
timeFrame: 24 months
Locations:
city: São Paulo
country: Brazil
facility: University of São Paulo
Study officials:
affiliation: University of Sao Paulo
name: Mariana Minatel Braga, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00063102: A Study of ABT-751 in Patients With Recurrent Breast Cancer After Taxane (Taxol or Taxotere) Therapy.
Official title: A Phase II Study of ABT-751 in Patients With Breast Cancer Refractory to Taxane Regimens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2003-06-23
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine if ABT-751 will decrease tumors, and determine how long the tumor shrinkage can be maintained in patients with breast cancer after having had taxol or taxotere. Patients will receive ABT-751 by mouth daily for 21 days. Patients will be off drug for 7 days before starting the next cycle of drug.


Eligibility criteria: Inclusion Criteria

* Stage IIIB or IV breast cancer.
* Recurrent tumor after or while on taxane therapy (taxol or taxotere).
* Able to tolerate normal activities of daily living.
* Adequate bone marrow, kidney and liver function.

Exclusion Criteria

* Pregnant or breast feeding.
* No anti-tumor therapy (including hormonal therapy or Herceptin) within 4 weeks of the start of ABT-751 administration.

Primary outcomes:
measure: Objective Response Rate in subjects with Breast cancer
timeFrame: 1 year
Secondary outcomes:
measure: Time to Tumor Progression (TTP)
timeFrame: 1 year
measure: Survival
timeFrame: 2 years
measure: Toxicities associated with treatment administration
timeFrame: 1 year
Other outcomes:
Locations:
city: Miami
country: United States
facility: Oncology-Hematology Group of South Florida
state: Florida
city: Plantation
country: United States
facility: Clinical Research Network, Inc.
state: Florida
city: Atlanta
country: United States
facility: Georgia Cancer Specialists
state: Georgia
city: Chicago
country: United States
facility: Northwestern University Medical School Division of Hematology/Oncology
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Cancer Center Section of of Hemtology/Oncology Indiana Cancer Pavilion
state: Indiana
city: South Bend
country: United States
facility: Northern Indiana Cancer Research Consortium
state: Indiana
city: Kansas City
country: United States
facility: Oncology & Hemotology Associates of Kansas City, PA
state: Missouri
city: Dallas
country: United States
facility: Texas Oncology
state: Texas
Study officials:
affiliation: Abbott
name: Helen Eliopoulos, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05155202: Clinical Relevance of Nicardipine Induced Hypoxemia in the Intensive Care Unit
Official title: Clinical Relevance of Nicardipine Induced Hypoxemia in the Intensive Care Unit. A Multicenter Prospective Observational Study Comparing Nicardipine and Urapidil
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypoxemic Respiratory Failure
Side Effect
Hypertensive Emergency
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2021-12-13
Enrollment: 300
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: All hypertensive patients in the intensive care unit

Brief summary: In the context of postoperative hypertension in the intensive care units, or after resusitation of hypertensive patients, intravenous antihypertensive drugs are often used. Among those drugs, Nicardipine is an effective drug, but with side effects such as inhibition of pulmonary vasoconstriction. Only preclinical studies have investigated the pathophysiology of this mechanism, and no clinical study have proven its clinical relevance.

The aim of this study is to establish the incidence of Nicardipine induced hypoxemia and to compare it to another antihypertensive agent, Urapidil.

Detailed description: Prospective observational study in 4 intensive care units in one general hospital and one university hospital.

Once Nicardipine or Urapidil infusion is started, data collection of respiratory related information such as type of ventilation, arterial partial pressure of oxygen, blood pressure, cardiac frequency.

Statistical analysis for two qualitative variables: Group (Nicardipine or Urapidil) and occurrence or worsening of hypoxemia. Secondary outcoumes analysed such as maximal drop of blood pressure, evolution of the PaO2/FiO2 ratio, length of hospital stay, duration of mechanical ventilation in the ventilated patients.

Analysis for different subgroups : Patients with known atelectasis, postoperative of cardiac surgery, neuro-intensive care.

Eligibility criteria: Inclusion Criteria:

* Major patient
* With acute arterial systolic hypertension over 140mmHg
* Requiring intravenous administration of one of the two following drugs : Urapidil or Nicardipine

Exclusion Criteria:

* Patient ventilated Under Nitrogen Monoxyde
* Contraindication to Nicardipine or Urapidil
* Refusal of the patient or his relatives
* Patient treated for pulmonary hypertension

Primary outcomes:
measure: Hypoxemia
timeFrame: During the twelve hours following start of drug infusion
Secondary outcomes:
measure: Efficacy of antihypertensive action
timeFrame: During the twelve hours following start of drug infusion
Other outcomes:
Locations:
city: Caen
country: France
facility: CHU CAEN
Study officials:
References:
Clinical trial NCT01159002: Evaluation of Gastrointestinal Motility With SmartPill
Official title: Clinical Evaluation of SmartPill Capsule for Investigation of Total Intestinal Transit Time and Intestinal Pathology in Critically Ill Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastrointestinal Motility
Keywords: Endoscopy, Video Capsule
Motility, Gastrointestinal
Lead sponsor: University of Louisville
Sponsor class: OTHER
First posted: 2010-07-08
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ICU patients with intracranial hemorrhage

Brief summary: The purpose of this study is to evaluate the clinical usefulness of a capsule (SmartPill\~) measuring pH, pressure and temperature from within the entire GI tract to determine gastric emptying time, combined small and large bowel transit time and total transit time. In addition, the Capsule will characterize pressure patterns and provide motility indices for the antrum and duodenum. It is believed that the condition of your digestive system can have a large impact on your overall physical health. Therefore,the investigators would like to assess whether using the pill device helps to determine any functional problems in patients in the ICU. The investigators are studying ICU patients because any change in their condition can have a large impact on their recovery.


Eligibility criteria: Inclusion Criteria:

* suffered from traumatic or non-traumatic intracranial hemorrhage and were admitted to an intensive care unit (ICU) at University of Louisville Hospital
* sedated and had tracheal intubation and mechanical ventilation
* older than 18 years

Exclusion Criteria:

* younger than 18 years
* multiple injuries, especially abdominal trauma or inflammatory bowel disease
* history of complicated abdominal surgery or unknown type of abdominal surgery
* clinical evidence of ileus or suspected bowel obstruction
* a pacemaker

Primary outcomes:
measure: Transit time
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville Hospital
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Stefan Rauch, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06823102: Brain Connectivity Analysis
Official title: Brain Connectivity Analysis to Predict Post Stroke Outcomes Following Traditional and Enhanced Neurorehabilitation by Transcranial Direct Current Stimulation and Anti-inflammatory Biomimetic Nanoparticles
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Neural Injury
Keywords: Non Invasive Brain Stimulation
Inflammation
Lead sponsor: IRCCS San Raffaele Roma
Sponsor class: OTHER
First posted: 2025-02-12
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Stroke remains the leading cause of permanent disability. The neuromodulation technique of transcranial Direct Current Stimulation (tDCS) has the potential to serve as an adjuvant therapy to enhance neuronal connectivity following stroke. By combining electroencephalography (EEG) and tDCS, this study aims to investigate changes in network connectivity and cerebral plasticity, which are key factors in functional recovery after stroke.

The objectives are to: 1) analyze how tDCS modulates neuronal activity, 2) evaluate persistent effects in follow-up assessments, and 3) predict patient outcomes. Studies on human subjects will be complemented by research in a mouse model of stroke to: 1) identify the molecular mechanisms underlying tDCS effects on functional recovery, 2) establish correlations among functional, molecular, and connectivity indices, and 3) assess the efficacy of biomimetic nanoparticles in targeting injured brain tissue to reduce inflammation, enhance neuronal plasticity, and support functional recovery.


Eligibility criteria: Inclusion Criteria:

Age 18-90

* First ischemic stroke occurring 3-30 days after onset
* Residual upper limb function
* Ability to provide informed consent and understand instructions

Exclusion Criteria:

* Severe spasticity (Ashworth \>2)
* Presence of additional neurological diseases
* Significant comorbidities
* History of intracerebral hemorrhage
* Severe neglect
* Contraindications to tDCS

Primary outcomes:
measure: Evaluate effects of tDCS in short-term follow-ups in terms of EEG Coherence
timeFrame: from month 8 to month 12
measure: Evaluate persistent effect of tDCS in long-term follow-ups of EEG Coherence
timeFrame: From month 15 to the end of project
measure: Evaluate effects of tDCS in short-term follow-ups in terms of EEG Connectivity
timeFrame: from month 8 to month 12
measure: Evaluate persistent effect of tDCS in long-term follow-ups of EEG Connectivity
timeFrame: From month 15 to the end of project
measure: Predict patients' outcome
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Casa di cura San Raffaele Pisana
Study officials:
References:
Clinical trial NCT02290002: Calcium Dobesilate Versus Coasting for Prevention of Ovarian Hyperstimulation Syndrome
Official title: Calcium Dobesilate Versus Coasting for Prevention of Ovarian Hyperstimulation Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Infertility
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2014-11-13
Enrollment: 200
Sex: FEMALE
Minimum age (years): 23
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to compare the effect of oral Calcium Dobesilate versus costing in the prevention of ovarian hyperstimulation syndrome (OHSS) in high-risk women underwent intracytoplasmic sperm injection (ICSI).

Detailed description: Two hundred and twenty women at risk of ovarian hyperstimulation syndrome during ICSI cycles will be randomly scheduled into two equal groups. In group A, (Calcium Dobesilate group), 1 cap / 8 hs Doxium ( 500mg) will be given at day of HCG injection and for 3 weeks ; while in group B (Coasting group), coasting (withholding gonadotrophins while maintaining pituitary suppression) follow up every day by measuring E2 for 3 days then either giving triggering or cycle cancellation is done

Eligibility criteria: Inclusion Criteria:

* Infertile women undergoing intracytoplasmic sperm injection or polycystic ovarian syndrome (PCO) with one of the following:

  * Presence of more than 20 follicles by ultrasound
  * E2 more than 3000 pg/ml
  * Retrieval of more than 15 follicles

Exclusion Criteria:

* None

Primary outcomes:
measure: Number of participants with ovarian hyperstimulation syndrome (OHSS)
timeFrame: every two weeks for eight weeks
Secondary outcomes:
measure: pregnancy rate
timeFrame: 14 days after embryos transfer
Other outcomes:
Locations:
city: Benha
country: Egypt
facility: Benha univesity hospital
Study officials:
affiliation: lecturer of ob/gyn
name: ahmed saad, MD
role: STUDY_CHAIR
affiliation: lecturer of ob/gyn
name: khalid mohamed, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01136902: Measuring Retinal Vessel Caliber in Relation to Dark Adaptation and Blood Glucose Level
Official title: Measuring Retinal Vessel Caliber in Relation to Dark Adaptation and Blood Glucose Level
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Keywords: Diabetes Mellitus
Retinal Vessels
Physiology
Lead sponsor: Glostrup University Hospital, Copenhagen
Sponsor class: OTHER
First posted: 2010-06-04
Enrollment: 14
Sex: ALL
Minimum age (years): 17
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with diagnosed Type 2 diabetes mellitus with none or minimal diabetic retinopathy.

Brief summary: The overall objective is to investigate, whether retinal blood vessel diameter change during the energy consuming dark adaptation process and if responses vary between low and high blood glucose.

Detailed description: All subjects are being studied using the same procedure. The study schedule takes place from 8 a.m. to 12 a.m. every time. Each subject shows up on one single day. Subjects are to show up fasting overnight with a break in insulin and/or oral antidiabetic treatment.

The study eye of each subject will be selected by randomisation. We seek to have an equal distribution of right and left eyes overall.

A first set of images will be taken after 5 minutes in "standardised daylight", in a room without light from outside, which eliminates any concerns about weather variations. After this the room is completely darkened. 2 set of images will be taken in the dark adapted state after 20 and 40 minutes. Subsequently the patient ingests the OGTT and will reach maximum blood glucose level after about 60-90 minutes. At this time, the subjects undergo the same "photo session" as above with high blood glucose levels.

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetic individuals.
* minimal or no diabetic retinopathy defined by no more than five microaneurysms or dot hemorrhages per eye on three non-stereoscopic 50 degree color fundus photographs

Exclusion Criteria:

* Test individuals with significant cataract, prior surgery to the eye, diabetic retinopathy, other serious eye disease, hypertension, other serious systemic disease

Primary outcomes:
measure: Vessel caliber
timeFrame: 1 day
Secondary outcomes:
measure: Blood glucose level
timeFrame: 1 day
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital at Glostrup
Study officials:
affiliation: Glostrup University Hospital, Copenhagen
name: Stig K Holfort, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00675402: Micro- and Macrovascular Adaptations in Patients With Peripheral Arterial Disease During Supervised Exercise Therapy
Official title: Micro- and Macrovascular Adaptations in Patients With Peripheral Arterial Disease During Supervised Exercise Therapy: a MRI Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: PAOD (Peripheral Arterial Obstructive Disease)
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2008-05-09
Enrollment: 117
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 referred to the vascular surgeon with complaints of claudication for their first time, will be asked to participate with the study, with respect toward the in- and exclusion criteria.

Brief summary: Given that previous studies demonstrated the feasibility of the required MRI techniques, we propose to study the macro- and microvascular adaptations in PAOD patients undergoing supervised exercise therapy. It is expected to provide valuable insights into the contribution of each vascular mechanism to the rehabilitation and to identify which vascular mechanism fails or is insufficient for a successful rehabilitation. Improvement of future treatment requires the identification of relevant adaptive mechanisms. With this we will provide early noninvasive MRI readout tools to diagnose and monitor the potential rehabilitation during any form of therapy for PAOD that affects the peripheral vasculature.


Eligibility criteria: Inclusion Criteria:

* Intermittent claudication according to a positive Rose-Edingburgh questionnaire
* Rest ankle-brachial pressure index (ABPI) \< 0,90 or 10% decline in ABPI after exercise
* Arterial stenosis/occlusion of femoro-popliteal territory according to duplex/MRA measurements
* Able to ondergo exercise therapy

Exclusion Criteria:

* Chronic or acute critical ischemia
* Treated by or planned for vascular surgery or percutaneous transluminal angioplasty
* Recent onset \<2 months
* Unable to perform treadmill exercise
* Diabetes mellitus
* Contra-indications for (Gadolinium-enhanced) MRI or thigh cuff inflation

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Hospital
state: Limburg
Study officials:
affiliation: Maastricht University Hospital, dep. of Radiology
name: WH Backes, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04978402: Interchromosomal Insertion Carriers PGT-SR
Official title: Management of Insertional Translocation Carriers for Preimplantation Genetic Testing and the Relevance of Sperm Analysis for Reproductive Risk Estimation.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Interchromosomal Breakpoint
Infertility
Keywords: Patients carriers of Insertional translocation (IT)
Several years of miscarriages
Abrotions and primary infertility
Interchromosomal insertion
PGT-SR
Sperm.
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-07-27
Enrollment: 3
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Interchromosomal insertions (IT) are rare and complex structural rearrangements. Theoretically, the risk to have a child to term with a malformation or mental retardation can reach 50% related to the proportion of unbalanced gametes produced from behavior of chromosomes during meiosis.

Brief summary: Interchromosomal insertions (IT) are rare and complex structural rearrangements. Theoretically, the risk to have a child to term with a malformation or mental retardation can reach 50% related to the proportion of unbalanced gametes produced from behavior of chromosomes during meiosis. However, the meiotic segregation of IT has rarely been studied. This study provide an accurate reproductive risk of IT carriers resulting from a combined analysis of Sperm-FISH and preimplantation genetic testing for structural rearrangement (PGT-SR) management of IT carriers.


Eligibility criteria: Inclusion criteria:

- Adult patient whom carrying Insertional translocation in the context of PGT-SR management

Exclusion Criteria:

- Patient who reject the study protocol

Primary outcomes:
measure: estimate the IT carrier's reproductive risk
timeFrame: day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Izabel Bernicot, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: