louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00884429: Effectiveness of Chest Physiotherapy in Infants With Acute Viral Bronchiolitis
Official title: Effectiveness of Chest Physiotherapy Actual Versus Conventional Techniques in Infants With Acute Viral Bronchiolitis. Random Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Viral Bronchiolitis
Keywords: Chest physiotherapy
Lead sponsor: Hospital Sirio-Libanes
Sponsor class: OTHER
First posted: 2009-04-20
Enrollment: 33
Sex: ALL
Minimum age (years): 28
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to verify the effectiveness of chest physiotherapy (actual versus conventional) on respiratory distress in infants with acute viral bronchiolitis.

Detailed description: The infants were random in three groups: Conventional techniques, actual techniques and suction of upper airways On the first two groups the infants were evaluated on admission,48,72hours and before hospital discharge. On third group was evaluated only on admission when SRV was collected.

Respiratory distress was evaluated with Wang's score by the physiotherapists and nurses not participating in the research.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of acute viral bronchiolitis
* RSV positive

Exclusion Criteria:

* Heart diseases
* Chronic lung disease
* Neurological diseases
* Parental refusal
* Previous wheezing episode
* ventilatory support

Primary outcomes:
measure: Respiratory distress
timeFrame: on first evaluation by physiotherapyst ( until 2 hours after hospital admission)
Secondary outcomes:
measure: Respiratory distress
timeFrame: 48 hours after first evaluation
measure: Respiratory distress
timeFrame: 72 hours after first evaluation
measure: Respiratory distress
timeFrame: 1 hour before hospital discharge
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital Sírio Libanês
Study officials:
affiliation: Hospital Sírio Libanês e UNINOVE
name: Evelim LF Dantas Gomes, Master
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gomes EL, Postiaux G, Medeiros DR, Monteiro KK, Sampaio LM, Costa D. Chest physical therapy is effective in reducing the clinical score in bronchiolitis: randomized controlled trial. Rev Bras Fisioter. 2012 Jun;16(3):241-7. doi: 10.1590/s1413-35552012005000018. Epub 2012 Apr 12.
Clinical trial NCT04520529: Identification of Prognostic Factors and New Therapeutic Targets in Cutaneous Lymphomas
Official title: Identification of Prognostic Factors and New Therapeutic Targets in Cutaneous Lymphomas
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cutaneous Lymphoma
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-08-20
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Cutaneous lymphomas are a heterogeneous group of extra-nodal lymphomas. The prognosis of cutaneous lymphomas is extremely variable from one subject to another. In the majority of cases, there is no cure for cutaneous lymphomas. Cutaneous lymphomas primarily affect the skin, and secondarily the blood, lymph nodes and possibly other organs. The discovery of new molecular prognostic factors will allow a better identification of patients at high risk of aggressive evolution and the implementation of a personalized therapeutic strategy. The identification of new therapeutic targets is necessary in order to develop new innovative treatments for cutaneous lymphomas.The primary objective is to identify novel molecular prognostic factors associated with 5-year overall survival in cutaneous lymphoma.


Eligibility criteria: Inclusion Criteria:

* Age\> 18 years old
* Informed consent signed by the patient
* Suspicion of primary cutaneous lymphoma or confirmed lymphoma according to WHO/ISCL/EORTC criteria

Exclusion Criteria:

* Patient under guardianship or curatorship
* Lack of affiliation to social security

Primary outcomes:
measure: overall survival
timeFrame: 5 years
Secondary outcomes:
measure: Progression free survival
timeFrame: 5 years
measure: Progression free survival
timeFrame: 10 years
measure: Overall survival
timeFrame: 10 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03416829: Preliminary Study 1 to Test the Effects of Ambulatory Voice Biofeedback
Official title: Preliminary Study 1 to Test the Effects of Ambulatory Voice Biofeedback in Small Groups of Patients With Vocal Hyperfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vocal Fold Nodules
Keywords: Ambulatory
Biofeedback
Voice
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2018-01-31
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This first study will enroll 3 groups of patients with vocal fold nodules that will receive different schedules of ambulatory voice biofeedback (100% frequency feedback, 25% frequency feedback, summary feedback) to avoid their upper 15th percentile of vocal loudness.

Detailed description: We will conduct this study (based on principles of motor learning) using novel smartphone-based ambulatory voice biofeedback systems aimed at improving the carryover of newly established vocal behaviors into daily life. This first study will determine which of three types of ambulatory feedback results in better learning/retention (100% frequency, 25% frequency, or delayed summary feedback every 2 minutes of voicing) of a new vocal behavior (reduced vocal intensity) in three groups of 15 patients with vocal fold nodules. Hypothesis: Patients receiving lower frequency or summary feedback will produce lower initial performance but higher short- and long-term retention than patients receiving feedback 100% of the time.

Eligibility criteria: Inclusion Criteria:

Patients with vocal fold nodules

Exclusion Criteria:

Non-English speakers are excluded because prompts on the smartphone app are only available in English

Primary outcomes:
measure: Percent Compliance
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital - Center for Laryngeal Surgery and Voice Rehabilitation
state: Massachusetts
Study officials:
affiliation: Mass General Hospital, Harvard, MGH IHP
name: Robert E Hillman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04931329: Onco-haematology Vigilance Card
Official title: Impact of an Onco-haematology Vigilance Card in the Optimisation of the Town-hospital Relationship.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Medical Oncology
Hematology
Molecular Targeted Therapies
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2021-06-18
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with onco-heamatologic disease treated with oral treatment (chemotherapy and/or targeted thérapies)

Brief summary: The objective of this study is to show the interest of setting up a drug vigilance card in Oncology in order to reinforce patient safety, develop compliance and avoid drug interactions when the patient consults town professionals or other specialists.

Detailed description: Recent developments in oral chemotherapy and targeted therapies have radically changed cancer patient management; ambulatory care is now common. Oral therapies afford many advantages, improving patient quality of life and autonomy by reducing hospital stays and involving patients in their own care. Optimising the care of cancer patients at home requires the coordinated intervention of hospital and town healthcare professionals and involvement of the patient to detect, prevent, and manage adverse events, avoid drug interactions, and educate patients. Preliminary work in haematology has highlighted (n = 31 patients) the interest of a "drug vigilance card" in three indications (Chronic Lymphocytic Leukaemia, Chronic Myeloid Leukaemia and Multiple Myeloma) with an increase in the town-hospital link.

This is an prospective cohort study. Following the announcement consultation, in addition to the personalised care plan, the information about the treatment will be contained in a drug monitoring card that will be given to the patient by the health professional (doctor or nurse). This drug monitoring card should be presented to the health professionals by the patient. During the entire period of treatment, the patient will have a card.

Eligibility criteria: Inclusion Criteria:

* All patients treated at Limoges University Hospital in Medical Oncology department, receiving oral treatment (chemotherapy and/or targeted therapies)

Exclusion Criteria:

* All patients treated at Limoges University Hospital in Medical Oncology department, receiving hormone therapy or IV treatment only.

Primary outcomes:
measure: measure patient satisfaction at 3 months
timeFrame: 3 months
Secondary outcomes:
measure: Measurement of caregiver satisfaction
timeFrame: 3 months
measure: Measurement of compliance reported by the GIRERD questionnaire
timeFrame: 3 months
measure: Measuring the satisfaction of treating physicians and health professionals
timeFrame: 3 months
measure: Evaluate the use of the QR code by health professionals/carers
timeFrame: 3 months
Other outcomes:
Locations:
city: Limoges
country: France
facility: CHU de Limoges
Study officials:
References:
Clinical trial NCT01390480: Effects of Vitamin D Supplementation in Subjects With New Onset of Type 1 Diabetes
Official title: Placebo Controlled Pilot Study on Effects of Vitamin D Supplementation in Subjects With New Onset of Type 1 Diabetes on Immunological, Endocrine and Metabolic Parameters: Step 2 in the Austrian Diabetes Prevention Programme
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 1 Diabetes
Keywords: vitamin D
Autoimmune disease
diabetes
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
Collaborators: name: Medical University of Vienna
First posted: 2011-07-11
Enrollment: 31
Sex: ALL
Minimum age (years): 6
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In this placebo controlled study the investigators aim to investigate the effects of vitamin D supplementation in subjects with new onset of type 1 diabetes on immunological, endocrine and metabolic parameters.

Detailed description: This is a bicentric, randomized placebo controlled, double blind study, with the aim to evaluate the effect of vitamin D supplementation in subjects with new onset of type 1 diabetes on immunological, endocrine and metabolic parameters.

The primary study goal is to evaluate the influence of vitamin D supplementation on the number and function of the master regulatory T-cells under controlled conditions within 13 months. The secondary study goals are a comprehensive immune phenotyping to determine whether Vit D produces changes consistent with a general improvement in immune homeostasis that supports ß-cell tolerating interventions, the assessment of ß-cell function in all subjects to obtain preliminary data on the effects of Vit D on ß-cell survival.

Eligibility criteria: Inclusion Criteria:

* males or females \> 6 years
* new onset of type 1 diabetes (3 months)

Exclusion Criteria:

* pregnancy
* hypercalcemia (\>2,65 mmol/L)
* chronic disease including a long-term medication over 4 weeks per year (except type 1 diabetes)

Primary outcomes:
measure: Increase and function of regulatory T-cells
timeFrame: 13 months
Secondary outcomes:
measure: Immunophenotyping
timeFrame: 13 months
measure: Insulin secretion
timeFrame: 13 months
measure: Calcium levels
timeFrame: 13 months
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University Graz
Study officials:
affiliation: Medical University of Graz
name: Thomas Pieber, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Treiber G, Prietl B, Frohlich-Reiterer E, Lechner E, Ribitsch A, Fritsch M, Rami-Merhar B, Steigleder-Schweiger C, Graninger W, Borkenstein M, Pieber TR. Cholecalciferol supplementation improves suppressive capacity of regulatory T-cells in young patients with new-onset type 1 diabetes mellitus - A randomized clinical trial. Clin Immunol. 2015 Dec;161(2):217-24. doi: 10.1016/j.clim.2015.08.002. Epub 2015 Aug 12.
Clinical trial NCT02655029: Study for the Recording of Adherence to Treatment With Perindopril/Indapamide/Amlodipine Fixed Dose Combination
Official title: Prospective, Non-interventional Study for the Recording of Adherence to Treatment With Perindopril/Indapamide/Amlodipine Fixed Dose Combination, in a Greek Population With Hypertension
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adherence to Medication Regime
Hypertensive Disease
Lead sponsor: Servier Hellas Pharmaceuticals Ltd.
Sponsor class: INDUSTRY
First posted: 2016-01-13
Enrollment: 2285
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Greek patients with arterial hypertension who receive treatment with Perindopril/Indapamide/Amlodipine fixed dose combination.

Brief summary: The main objective of this study is to record, in routine clinical practice, patients' adherence to treatment with Perindopril/Indapamide/Amlodipine fixed dose combination, during 4 months treatment.

Detailed description: This is a non-interventional study aiming to record adherence to treatment with Perindopril/Indapamide/Amlodipine fixed dose combination. In parallel blood pressure levels will be recorded, as well as safety and tolerability of this fixed dose combination.

Eligibility criteria: Inclusion Criteria:

* Male or female, ambulatory patients \>18 years old.
* Clinically diagnosed essential arterial hypertension.
* Under treatment with Perindoril/Indapamide/Amlodipine fixed dose combination.
* The patient has given his/her written consent after being informed, before his inclusion in the study.

Exclusion Criteria:

* Secondary arterial hypertension.
* Serious end stage diseases, severe neuropsychiatric diseases, cerebrovascular event with serious residual lesions, scheduled procedure or surgical operation or hospital admission.
* Pregnancy, lactation or intention to become pregnant.

Primary outcomes:
measure: Adherence to treatment
timeFrame: Change of total score of compliance scale between baseline and 1st month and between 1st and 4th month of treatment
Secondary outcomes:
measure: Systolic Blood Pressure
timeFrame: All visits (baseline, 1st and 4th month of treatment)
measure: Diastolic Blood Pressure
timeFrame: All visits (baseline, 1st and 4th month of treatment)
measure: Adverse events recording leading to treatment discontinuation
timeFrame: 1st and 4th month of treatment
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Ippokratio University Hospital of Athens
Study officials:
affiliation: Ippokrateion General Hospital of Athens
name: Konstantinos Tsioufis, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02388880: Effect of Intrathoracic Pressure Regulation on Decreased Cerebral Perfusion (4hour)
Official title: Physiological Effects of Intrathoracic Pressure Regulation in Patients With Decreased Cerebral Perfusion Due to Brain Injury or Intracranial Pathology (4 Hour Use)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Head Injury
Intracranial Pathology
Compromised Cerebral Perfusion
Keywords: ITPR
CPP
TBI
traumatic brain injury
cerebral perfusion pressure
intrathoracic pressure regulator
Lead sponsor: Advanced Circulatory Systems
Sponsor class: INDUSTRY
Collaborators: name: United States Army Institute of Surgical Research
First posted: 2015-03-17
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the physiological response to application of the Intrathoracic Pressure Regulator (ITPR) in patients with compromised cerebral circulation. The study will evaluate the physiological response to intrathoracic pressure regulation (IPR) therapy in hemodynamically stable patients with compromised cerebral circulation who are on ventilatory support.


Eligibility criteria: Inclusion Criteria:

* ≥18 years of age
* intubated and mechanically ventilated on a volume controlled mode
* head injury or other intracranial pathology and compromised cerebral perfusion
* arterial line in place or alternative with continuous pressure monitoring
* SpO2 ≥90%
* mean arterial pressure \>55
* admission to ICU or about to undergo neurosurgery with planned placement of an invasive intracranial pressure monitor
* inclusion presents no significant delays to planned emergent neurosurgery
* prior written informed consent

Exclusion Criteria:

* cardiac or pulmonary injury
* confirmed pneumothorax or hemothorax
* serious neck injury resulting in neck swelling with jugular venous compression
* evidence of ongoing uncontrolled bleeding
* respiratory disease such as COPD, interstitial lung disease, or other parenchymal or pulmonary vascular disease
* marked hypertension at time of device use defined as systolic blood pressure \>180 mmHg
* congestive heart failure
* women with positive serum or urine pregnancy test or breast feeding

Primary outcomes:
measure: Cerebral Perfusion Pressure (CPP)
timeFrame: During 240 minutes of device use
Secondary outcomes:
measure: Mean Arterial Pressure (MAP)
timeFrame: baseline to end of ITPR use
measure: Intracranial Pressure (ICP)
timeFrame: baseline to end of ITPR use
measure: End-tidal Carbon Dioxide (EtCO2)
timeFrame: baseline to end of ITPR use
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
References:
Clinical trial NCT03810092: Analysis of the Relationship Between Early Postoperative Anemia and the Evolution of Autonomy at 6 Months in Patients 75 Years of Age and Older Operated on Following a Fracture of the Upper End of the Femur
Official title: Analysis of the Relationship Between Early Postoperative Anemia and the Evolution of Autonomy at 6 Months in Patients 75 Years of Age and Older Operated on Following a Fracture of the Upper End of the Femur
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Femoral Fracture
Lead sponsor: Centre Hospitalier Departemental Vendee
Sponsor class: OTHER
First posted: 2019-01-18
Enrollment: 255
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study is intended for patients over 75 years of age who have had a fracture of the upper extremity of the femur operated on.

Brief summary: Fracture of the upper extremity of the femur is a condition whose frequency increases with age. It is a serious disease, with multiple consequences such as a decrease in life expectancy, quality of life and patient autonomy. In this observational study, the investigators wish to evaluate the evolution of the autonomy of very elderly patients operated on for an upper extremity femur fracture as a function of early post-operative anemia.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 75 years
* Patient operated on a fracture of the upper extremity of the femur
* Patient, family or close relative who does not object to participation in the study
* Patient affiliated to a social security system
* Patient who can be monitored as part of the protocol

Exclusion Criteria:

* Refusal to participate in the study (patient, family or trusted relative)
* Patient with support on the operated limb not authorized by the surgeon
* Patient with an associated fracture (polytrauma, concomitant trauma to the upper limb...)
* Patient with a pathologic fracture
* Patient included in Category 1 interventional research (involving a drug or medical device)
* Patient deprived of liberty
* Patient not affiliated to a social security system

Primary outcomes:
measure: Hemoglobin rate
timeFrame: 5 days after surgery
measure: Questionnaire Activities of Daily Living
timeFrame: Pre-fractural and 6 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
city: Cholet
country: France
facility: CH Cholet
city: La Roche sur Yon
country: France
facility: Centre Hospitalier Départemental Vendée
city: La Rochelle
country: France
facility: CH La Rochelle
city: Saint-Malo
country: France
facility: CH Saint Malo
Study officials:
affiliation: CHD Vendée
name: Romain DECOURS
role: PRINCIPAL_INVESTIGATOR
References: