louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00470457: A Randomized Study to Evaluate a Novel Method of Specific Allergen Immunotherapy
Official title: A Randomized Study to Evaluate a Novel Method of Specific Allergen Immunotherapy in Grass and/or Tree Pollen Allergic Subjects by Intralymphatic Allergen Administration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rhinoconjunctivitis Due to Grass Pollen Allergy
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: AlleCure
First posted: 2007-05-07
Enrollment: 156
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: Allergen specific immunotherapy (SIT) is the only causative treatment of IgE-mediated allergies. The disadvantages of SIT, however, are the requirement of numerous allergen administrations over three to five years, and that the treatment itself causes frequent allergic reactions. We aim at enhancing grass pollen SIT in hay fever patients by injecting the allergen directly into subcutaneous lymph nodes. In a monocentric randomized trial safety and efficacy of intralymphatic immunotherapy (ILIT) with 3 low dose grass pollen extract injections over 2 months are compared to subcutaneous immunotherapy (SCIT) using 54 injections over 3 years.

* Trial with immunodulatory product / biological


Eligibility criteria: Inclusion criteria:

* Written informed consent
* History of allergic rhino-conjunctivitis in spring and summer
* Age 18 years to 65 years
* Positive skin prick test to grass pollen

Exclusion criteria:

* Blood donation within previous 30 days
* Surgery within the previous 30 days
* Use of investigational drugs within previous 90 days
* Pregnancy or nursing
* Mastocytosis
* Significant cardiovascular disease
* Hypertension
* Active infectious disease
* Significant hepatic disease
* Significant renal disease
* Significant hematological disorder
* Significant pulmonary disease
* Moderate or severe asthma
* Autoimmune disease
* History of malignancy.
* Contraindicated medications were immunosuppressive agents, beta-blockers, ACE-inhibitors, and tricyclic antidepressants.

Primary outcomes:
measure: Safety efficacy and toxicity
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Clinic for Dermatology University Hospital of Zurich
Study officials:
affiliation: UniversitaetsSpital Zuerich
name: Studienregister MasterAdmins
role: STUDY_DIRECTOR
References:
citation: Senti G, Prinz Vavricka BM, Erdmann I, Diaz MI, Markus R, McCormack SJ, Simard JJ, Wuthrich B, Crameri R, Graf N, Johansen P, Kundig TM. Intralymphatic allergen administration renders specific immunotherapy faster and safer: a randomized controlled trial. Proc Natl Acad Sci U S A. 2008 Nov 18;105(46):17908-12. doi: 10.1073/pnas.0803725105. Epub 2008 Nov 10.
Clinical trial NCT05692648: Effect of Repositioning Frequency Neonates Receiving Phototherapy
Official title: Effect of Repositioning Frequency on Bilirubin Level and Infant Comfort in Neonates Receiving Phototherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bilirubinemia
Newborn Jaundice
Keywords: bilirubin
comfort
neonates
phototherapy
positioning
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2023-01-20
Enrollment: 60
Sex: ALL
Minimum age (years): 35
Maximum age (years): 42
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: single-centered, single-blind, 3-arm, pretest-posttest parallel-group randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: Purpose: The present study was conducted to determine the effect of repositioning frequency during phototherapy on bilirubin level and neonates comfort.

Design and methods: This was a single-centered, single-blind, 3-arm, pretest-posttest parallel-group randomized controlled trial conducted in a neonatal intensive care unit. Participants were randomly assigned to one of three groups: Supine position group (n = 20), hourly position change group (n = 20), and control group (n = 20). The bilirubin level and comfort levels of the neonates were evaluated.

Detailed description: Purpose: The present study was conducted to determine the effect of repositioning frequency during phototherapy on bilirubin level and neonates comfort.

Eligibility criteria: Inclusion Criteria:

* gestational age between 35-42 weeks
* birth weight of 2000 g or more
* indication for phototherapy
* no previous phototherapy,
* no medical diagnosis other than prenatal hyperbilirubinemia
* stable health status
* no clinical signs of dehydration
* transition to oral feeding, no sucking problems
* being at least 2 days old on the day of phototherapy

Exclusion Criteria:

* a sudden change in stability during phototherapy and
* phototherapy duration of less than 24 hours

Primary outcomes:
measure: Change in bilirubin level
timeFrame: Baseline and 24 hours after phototherapy
measure: comfort level questionnaire
timeFrame: up to 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Selcuk University
state: Selcuklu/Konya
Study officials:
affiliation: Selcuk University
name: Sibel Kücükoglu, professor
role: STUDY_DIRECTOR
affiliation: Selcuk University
name: Fatma Tas Arslan, professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05103748: Function Evaluation of Older Patients With Vertigo and Intervention Study of New Rehabilitation Methods
Official title: Function Evaluation of Older Patients With Vertigo and Intervention Study of New Rehabilitation Methods
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vertigo
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2021-11-02
Enrollment: 226
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: By evaluating the balance, gait and cognitive functions of the elderly patients with vertigo, the relevant functional disorders of the elderly patients with vertigo were clarified, and the functional disorders of the elderly patients with vertigo were improved through the new rehabilitation intervention.


Eligibility criteria: Inclusion Criteria:

Older than 60 years old

It meets the diagnostic criteria of vertigo disease

Agree to participate in the experiment

Exclusion Criteria:

Complete paralysis caused by severe cerebrovascular diseases

Patients with disability and dementia and long-term bedridden

Unwilling to cooperate with the visitors

Patients who did not meet the inclusion criteria

Primary outcomes:
measure: Short physical performance battery scale
timeFrame: 8 weeks
measure: Berg balance scale
timeFrame: 8 weeks
measure: Dynamic Gait Index scale
timeFrame: 8 weeks
measure: Montreal Cognitive Assessment Scale
timeFrame: 8 weeks
measure: Dizziness handicap inventory scale
timeFrame: 8 weeks
measure: Visual analogue scale
timeFrame: 8 weeks
measure: Generalized Anxiexy Disorde-7 scale
timeFrame: 8 weeks
measure: Morse Fall scale
timeFrame: 8 weeks
measure: Frail scale
timeFrame: 8 weeks
measure: Mini-mental State Examination
timeFrame: 8 weeks
Secondary outcomes:
measure: Dataset of functional magnetic resonance imaging on brain
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Xi'an
country: China
facility: The First Affiliated Hospital of Air Force Medical University
state: Shaanxi
Study officials:
affiliation: Department of Geriatrics, Xijing Hospital, Air Force Medical University
name: Xiaoming Wang
role: STUDY_DIRECTOR
References:
Clinical trial NCT00453726: Brain Natriuretic Peptide (BNP) Levels in Patients in Non Invasive Mechanical Ventilation
Official title: Evaluation of BNP in Patients With Severe Acute Respiratory Failure Requiring Non Invasive Mechanical Ventilation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Insufficiency
Keywords: Natriuretic peptide brain
Continuous positive airway pressure
Intermittent positive pressure breathing
Respiratory insufficiency
Lead sponsor: Ospedale S. Giovanni Bosco
Sponsor class: OTHER
First posted: 2007-03-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients of the city of Torino, admitted to the emergency department for acute respiratory failure.

Brief summary: The purpose of the study is to evaluate variation of BNP in non invasive mechanical ventilated patients with severe acute respiratory failure.

Detailed description: The aim of the study is to evaluate in patients with severe acute respiratory failure requiring non invasive mechanical ventilation BNP levels at admission and during the following 24 hours during non invasive mechanical ventilation (Non Invasive Positive Pressure Ventilation or Continuous positive airway pressure).

Because in patients affected by acute respiratory failure it is often difficult to distinguish if the disease precipitating the respiratory failure is a cardiac disease or a lung disease, aim of the present study is to evaluate the discriminating role that BNP could have in this group of patients; evaluation will be completed, once obtained clinical stabilisation, with an echocardiography and respiratory functional test.

Eligibility criteria: Inclusion Criteria:

* Severe respiratory distress (use of respiratory accessory muscles);
* Respiratory rate \> 25 per minute;
* Respiratory acidosis (pH \< 7.35 and PaCO2 \> 45 mmHg);
* PaO2/FiO2 \< 250

Exclusion Criteria:

* Age \< 18 years;
* Facial deformities;
* Pneumothorax;
* Shock or systolic arterial pressure below 90 mmHg with amine infusion;
* Life-threatening arrhythmias;
* Need for immediate endotracheal intubation (PaO2/FiO2 \< 100 with FiO2 100%, respiratory rate \< 10, GCS \< 8);
* Lack of co-operation from the patient;
* Recent esophageal-gastric surgery;
* Inability to clear secretions;
* Drugs that may interfere with BNP secretion;
* Severe obesity;
* Hepatic cirrhosis with ascitis;
* Endocrine disease.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Torino
country: Italy
facility: Ospedale San Giovanni Bosco Medicina d'Urgenza
state: Piedmont
Study officials:
affiliation: Ospedale San Giovanni Bosco ASL4 Torino Italy
name: Giovanni Ferrari, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00492557: Study Evaluating Safety and Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine With Influenza Vaccine in Adults
Official title: A Phase 3, Randomized, Double-blind Trial to Evaluate Safety, Tolerability, and Immunogenicity of a 13-Valent Pneumococcal Conjugate Vaccine When Administered Concomitantly With Trivalent Inactivated Influenza Vaccine in Healthy Adults 65 Years of Age or Older, Who Are Naive to 23-Valent Pneumococcal Polysaccharide Vaccine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pneumococcal Infections
Keywords: Pneumococcal Disease
Pneumococcal Conjugate Vaccine
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-06-27
Enrollment: 1185
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The 13-valent pneumococcal conjugate vaccine (13vPnC) is being developed for adults to prevent pneumococcal diseases such as meningitis (inflammation of the brain lining), septicemia (blood poisoning), and pneumonia (inflammation of the lungs). As trivalent influenza vaccine (TIV) is frequently given to adults, it is important to show that both vaccines can safely be given together without affecting the immune response (body's ability to protect against disease).


Eligibility criteria: Inclusion Criteria:

* Generally healthy male or female adults 65 years of age or older.
* Available for the duration of the trial - approximately 2 months.
* No previous vaccination with any pneumococcal vaccine.
* No history of severe adverse reaction associated with a vaccine.
* No allergy to egg proteins (eggs or egg products) and chicken proteins.

Primary outcomes:
measure: TIV Comparisons: Percentage of Participants Achieving at Least a 4-fold Increase in the Titer of the Standard Hemagglutination Inhibition Assay (HAI)
timeFrame: Baseline and 1 month after TIV vaccination
measure: 13vPnC Comparisons: Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC)
timeFrame: 1 month after 13vPnC vaccination
Secondary outcomes:
Other outcomes:
measure: Percentage of Participants With Pre-specified Local Reactions
timeFrame: Days 1 through 14 after 13vPnC vaccination
measure: Percentage of Participants With Pre-specified Systemic Events
timeFrame: Days 1 through 14 after 13vPnC vaccination
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01583257: Pilot Study: Active Video Gaming to Facilitate Physical Activity and Quality of Life in Kidney Transplant Recipients
Official title: Pilot Study: Active Video Gaming to Facilitate Physical Activity and Quality of Life in Kidney Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Quality of Life
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
Collaborators: name: Novartis Pharmaceuticals
First posted: 2012-04-23
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Background:

Renal transplant recipients have a greater risk of morbidity and mortality primarily due to cardiovascular disease when compared to the general population. Cardiovascular disease is responsible for 50% to 60% percent of deaths amongst renal transplant population and death from cardiovascular disease is a leading cause of functioning graft loss.

Physical activity is an effective form of secondary prevention in existing cardiovascular disease reducing all-cause mortality by 25%-30% and has demonstrated positive effects overall on quality of life and well-being. Transplant patients who participated in regular cardiovascular exercise have significant more positive scores on the SF-36 Health Status Questionnaire in comparison to inactive transplant recipients.

Active video gaming is evolving as an innovative method to increase physical activity. Active video gaming has supported physical activity in children and youth. There is however a paucity of literature examining interactive games as a means to facilitate physical activity and its impact on CVD and quality of life in the adult population nor any literature examining AVG and its impact on an adult surgical population.

This pilot study is designed to determine if Active Video Gaming is feasible and is able to lead to behavioral modifications and Quality of Life improvement.

Subject Selection:

This is a pilot study during which 10 patients who have undergone renal transplant will be selected to exercise with Active Video Gaming for a duration of 3 months. The program activity will begin 6 months post surgery.


Eligibility criteria: Inclusion Criteria:

* Renal transplant patient who want and are able to take part in this study

Exclusion Criteria:

* Cardiac or pulmonary dysfunction diagnosed through preoperative assessment.
* Any surgical complication incurred with transplantation.
* Peripheral vascular disease.

Primary outcomes:
measure: Quality of Life
timeFrame: 3 months post intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: QEII Health Sciences Center, MOTP
state: Nova Scotia
Study officials:
affiliation: CDHA / Dalhousie University
name: Ian P Alwayn, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02148757: Doppler Ultrasound Following Unicondylar Knee Replacement to Determine the Incidence of Postoperative DVT
Official title: Doppler Ultrasound Following Unicondylar Knee Replacement to Determine the Incidence of Postoperative DVT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Number of Deep Venous Thrombosis (DVT)
Keywords: DVT
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2014-05-28
Enrollment: 112
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Purpose of this study is to determine the incidence of deep venous thrombosis after partial knee replacement.

Detailed description: Doppler Ultrasound will be performed 2-6 weeks after surgery.

Eligibility criteria: Inclusion Criteria:

* Unilateral partial knee replacement
* Postoperative anticoagulation with aspirin 325 twice daily
* Regional anesthesia
* Inflatable garments worn during hospitalization

Exclusion Criteria:

-Bilateral partial knee replacement

Primary outcomes:
measure: Deep venous thrombosis
timeFrame: 2-6 weeks after surgery
Secondary outcomes:
measure: body mass index
timeFrame: at date of surgery
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
References:
Clinical trial NCT04690257: Effectiveness of Art Therapy on Reducing Pain and Anxiety in Children Receiving Venipuncture
Official title: The Effectiveness of Art Therapy on Reducing Pain and Anxiety in Children Receiving Venipuncture in a Pediatric Department: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Venipuncture
Pain
Anxiety
Fear
Lead sponsor: University of Witten/Herdecke
Sponsor class: OTHER
First posted: 2020-12-30
Enrollment: 144
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Venipuncture is one of the most common stressful procedures in children. Managing pain and fear of venipuncture procedure recommended strongly because it may change children's memory for procedural pain and the subsequent acceptance of later health care painful interventions. Prior painful experiences can reduce the acceptance of later health care, hence making it more difficult for both patients and nurses.

There was clear evidence that the distraction method is the most performed as a psychological technique performed to decrease venipuncture-related pain and distress and supporting its efficacy in children.

The aim of this study to investigate the effectiveness of TICK-B on children's pain and anxiety during venipuncture procedure.

Detailed description: Note:

The first registration number for the protocol of Ph.D. was approved as 10092019-6 on 10th September 2019 It approved the grant to publish the result as 20072020-3 on 23, August,

Eligibility criteria: Inclusion Criteria:

* being between 6-12 years old,
* a physician order was placed for the blood sample,

Exclusion Criteria:

* Chronic medical condition.
* Those whose parent not participated,
* Neurodevelopmental delayed, verbal difficulties, difficulties in hearing or visual,
* Unconsciousness.
* Take a medication analgesic in the past 6 hrs.
* history of syncope.

Primary outcomes:
measure: Pain Intensity Measure
timeFrame: Immediately after venipuncture (1-2 min)
Secondary outcomes:
measure: Fear Measure
timeFrame: Immediately after venipuncture (1-2 min. )
Other outcomes:
measure: Pain and anxiety measured by parents and observe.
timeFrame: Immediately after venipuncture (1-2 min.)
Locations:
city: Witten
country: Germany
facility: Sherzad Suleman
state: NRW
Study officials:
affiliation: Duhok University
name: Akram M Atrushi, Professor
role: STUDY_CHAIR
affiliation: Witten\Herdecke University
name: Margareta Halek, Professor
role: STUDY_DIRECTOR
References:
citation: Suleman SK, Atrushi A, Enskar K. Effectiveness of art-based distraction on reducing pediatric patients' pain and anxiety during venipuncture: A randomized controlled trial. Complement Ther Clin Pract. 2022 Aug;48:101597. doi: 10.1016/j.ctcp.2022.101597. Epub 2022 Apr 30.
Clinical trial NCT04753957: Pharmacokinetics of Progesterone in Pregnancy-2
Official title: Pharmacokinetics of Progesterone in Pregnancy-2
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Pregnancy Related
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2021-02-15
Enrollment: 3
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: OTHER

Brief summary: The objective of this study is to evaluate the local pharmacokinetics of progesterone in pregnancy through evaluation of progesterone levels in maternal serum, endometrium, and cordblood in pregnant patients undergoing scheduled cesarean delivery.

Detailed description: The objective of this pilot study is to evaluate the local pharmacokinetics of progesterone in pregnancy through evaluation of progesterone levels in maternal serum, endometrium, and cordblood in pregnant patients undergoing scheduled cesarean delivery.

Eligibility criteria: Inclusion Criteria:

* Age ≥18yo
* Singleton gestation, ≥36 0/7 weeks gestation
* Scheduled cesarean delivery at Thomas Jefferson University Hospital or affiliate

Exclusion Criteria:

* Contraindication to vaginal progesterone suppository

  * Active hepatic disease
  * Prior or current thrombus
  * Known adverse reaction to progesterone
  * Peanut allergy
* Bleeding disorder (such as thrombophilia)
* Use of 17-hydroxyprogesterone caproate in the pregnancy
* Use of vaginal progesterone in the pregnancy
* History of adverse reaction to progesterone
* Current vaginitis

Primary outcomes:
measure: Endometrial (ng/mg) progesterone time/concentration profile
timeFrame: 12 hours
measure: Plasma (ng/ml) progesterone time/concentration profile
timeFrame: 12 hours
Secondary outcomes:
measure: Side effect survey
timeFrame: 24hr after delivery
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
Study officials:
References: