louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00421655: A Trial of Grazax in Subjects With Hayfever
Official title: A Phase III Trial Assessing the Efficacy and Safety of Grazax in Subjects With Seasonal Grass Pollen Induced Rhinoconjunctivitis With or Without Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Allergy
Lead sponsor: ALK-Abelló A/S
Sponsor class: INDUSTRY
First posted: 2007-01-12
Enrollment: 329
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: The trial is performed to evaluate the efficacy and safety of specific immunotherapy with Grazax for treatment of grass pollen induced allergy.


Eligibility criteria: Inclusion Criteria:

* History of grass pollen allergy
* Positive skin prick test to grass
* Positive specific IgE to grass

Exclusion Criteria

* FEV1 \<70% of predicted value

Primary outcomes:
measure: Recording of allergy symptoms
timeFrame: Grass pollen season 2007
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: CompleWare Corporation
state: Iowa
Study officials:
affiliation: ALK-Abelló A/S
name: Kim Simonsen, MD
role: STUDY_DIRECTOR
References:
citation: Murphy K, Gawchik S, Bernstein D, Andersen J, Pedersen MR. A phase 3 trial assessing the efficacy and safety of grass allergy immunotherapy tablet in subjects with grass pollen-induced allergic rhinitis with or without conjunctivitis, with or without asthma. J Negat Results Biomed. 2013 Jun 1;12:10. doi: 10.1186/1477-5751-12-10.
Clinical trial NCT03813355: Evaluation of tDCS Efficacy in Enduring Anorexia Nervosa
Official title: Evaluation of tDCS Efficacy in Enduring Anorexia Nervosa : a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Anorexia Nervosa
Keywords: brain stimulation
Body Mass Index
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2019-01-23
Enrollment: 17
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Approximately 20% of anorexia nervosa cases do not respond to conventional management strategies: cognitive behavioral therapy, weight gain contract, drug treatments, etc ... - whether they are applied outpatients or during very long hospitalizations. These situations of chronic evolution are characterized by a high rate of mortality. Brain stimulation could be an alternative therapy for these patients. tDCS (transcranial direct current stimulation) is a non-invasive stimulation technique that has demonstrated beneficial effects in other psychiatric conditions such as major depression or schizophrenia.

The objectives of the study will be to evaluate the efficacy of tDCS in anorexia nervosa resistant to conventional treatments on weight gain, eating behavior, psychological and nutritional behavioral scales, cognition, connectivity and brain activity.


Eligibility criteria: Inclusion Criteria:

* Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 anorexia nervosa criteria
* Body Mass Index (BMI) \< 17kg/m2
* Conventional treatment failure over the last 12 months
* Refusal or no indication of artificial nutrition

Exclusion Criteria:

* Artificial nutrition
* Other chronic diseases
* drug use (except tobacco)
* pregnancy
* Edinburgh score \< 14

Primary outcomes:
measure: Body Mass Index (BMI)
timeFrame: weeks 8
Secondary outcomes:
measure: Eating Disorder Inventory (EDI)
timeFrame: weeks 8
measure: Dutch Eating Behavior Questionnaire (DEBQ)
timeFrame: weeks 8
measure: Beck Depression Inventory (BDI)
timeFrame: weeks 8
measure: State-Trait Anxiety Inventory (STAI)
timeFrame: weeks 8
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
city: Grenoble
country: France
facility: CHU Grenoble
city: Lyon
country: France
facility: Hospices Civils de Lyon
city: Saint-Etienne
country: France
facility: CHU Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Catherine Massoubre, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01930955: Non-antibiotic Prescribing for Acute Upper Respiratory Tract Infection
Official title: Non-antibiotic Prescribing for Acute Upper Respiratory Tract Infection：a Randomized-control Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Acute Upper Respiratory Tract Infection
Keywords: Non-antibiotic prescribing
acute upper respiratory tract infection
white cell count
vomiting
Lead sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Sponsor class: OTHER
First posted: 2013-08-29
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Some acute upper respiratory tract infection(AURI) in children is characterized by fever and vomiting,and it is one common reason for visiting a pediatrician. White blood count(WBC) usually increased in this children patients,hence antibiotics are often prescribed properly assumed. In the present study, it was hypothesized that it was not necessary to prescribe amoxicillin for the children.

Detailed description: After inclusion of eligible children patients,one group was prescribed amoxicillin,and another not.

Eligibility criteria: Inclusion Criteria:

* Acute upper respiratory tract infection
* Fever
* Vomiting
* Increased white blood cell

Exclusion Criteria:

* 0ther symptoms of digestive system
* Headache

Primary outcomes:
measure: fever
timeFrame: 3 days
Secondary outcomes:
measure: vomiting
timeFrame: 2 days
Other outcomes:
measure: white cell count
timeFrame: 3 days
Locations:
city: Chongqing
country: China
facility: Department of Pediatrics, Daping Hospital, Research Institute of Surgery, Third Military Medical University
state: Chongqing
Study officials:
affiliation: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
name: Long Chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03896555: Intrafractional Head Movement During Radiosurgery
Official title: Intrafractional 6D Head Movement With Mask Fixation During Stereotactic Intracranial RT-sessions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Metastases, Adult
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
First posted: 2019-04-01
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 5 Patients with a single intracranial tumour treated with stereotactic radiation therapy

Brief summary: This study investigates the intrafractional accuracy of a frameless thermoplastic mask used for head immobilization during stereotactic radiotherapy. Non-invasive masks cannot completely prohibit head movements. Previous studies attempted to estimate the magnitude of intrafractional inaccuracy by means of pre- and postfractional measurements only. However, this might not be sufficient to accurately map also intrafractional head movements.

Intrafractional deviation of mask-fixed head positions is measured in five patients during a total of 94 fractions by means of close-meshed repeated ExacTrac measurements conducted during the entire treatment session. From the obtained data the investigators evaluate the need to adjust safety margins around the gross tumor volume (GTV) whenever the investigated thermoplastic mask is used instead of invasive ring fixation.


Eligibility criteria: Inclusion Criteria:

* single intracranial tumour or metastasis
* stereotactic radiation therapy planned
* immobilization with thermoplastic mask

Primary outcomes:
measure: 3D Head deviation
timeFrame: 5 to 20 days
Secondary outcomes:
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Medical University Innsbruck
Study officials:
affiliation: Medical University Innsbruck
name: Meinhard Nevinny-Stickel, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mangesius J, Seppi T, Weigel R, Arnold CR, Vasiljevic D, Goebel G, Lukas P, Ganswindt U, Nevinny-Stickel M. Intrafractional 6D head movement increases with time of mask fixation during stereotactic intracranial RT-sessions. Radiat Oncol. 2019 Dec 18;14(1):231. doi: 10.1186/s13014-019-1425-7.
Clinical trial NCT05196555: Cleft Palate With Intravelar Veloplasty Repair
Official title: Microscopic Surgical Repair of Cleft Palate With Inravelar Veloplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cleft Palate
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2022-01-19
Enrollment: 30
Sex: ALL
Minimum age (years): 9
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Cleft palate repair is the most important component of cleft surgery, not only in that it determines the outcome as far as speech and communication are concerned, but also in that it potentially has the greatest impact on maxillary growth and the dental arch relationship. Sommerlad technique has been described as a more physiological approach, aiming to restore the anatomy of the velum. This technique, often described as radical intravelar veloplasty, has the following distinctive components: a radical retroposition of velar musculature (m. levator veli palatini, m. palatoglossus, and m. palatopharyngeus), combined with minimal dissection of the hard palate, a tensor tenotomy, and the repair of the m. levator sling


Eligibility criteria: Inclusion Criteria:

* Patients with isolated cleft palate age from 9 months to 18 years.
* Patients with submucous cleft.
* Velopharyngeal incompetence (VPI) for palatal re-repair.

Exclusion Criteria:

* Medically unfit patients.
* Syndromic patients with cleft lip and palate.
* Patients with cleft palate associated with multiple congenital anomalies.
* Patients with neurological disorders.

Primary outcomes:
measure: change in soft palate elevation
timeFrame: Baseline, immediately after procedure
measure: change in tongue motion assessment
timeFrame: Baseline, immediately after procedure
measure: change in lips motion assessment
timeFrame: Baseline, immediately after procedure
measure: change in nasal airflow
timeFrame: Baseline, immediately after procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria Faculty of Dentistry
Study officials:
References:
Clinical trial NCT05959655: Modern Urodynamics System Efficacy (MUSE) Study
Official title: Modern Urodynamics System Efficacy (MUSE) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urologic Diseases
Urodynamics
Keywords: Lower Urinary Tract Dysfunction
Urinary Incontinence
Overactive Bladder
Urodynamics
Uroflowmetry
Lead sponsor: Bright Uro
Sponsor class: INDUSTRY
First posted: 2023-07-25
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The goal of this prospective trial is to evaluate the feasibility, efficacy, and safety of the Glean Urodynamics System (GUS) for use in the clinic to collect vesical pressure data in adult males and females with lower urinary tract symptoms.

The main question\[s\] it aims to answer are:

• What is the feasibility, efficacy, and safety of GUS for use in clinical to collect vesical pressure data in adult males and females with lower urinary tract symptoms?

Participants will undergo a planned conventional urodynamics exam after which the Glean Sensor will be inserted and ambulatory urodynamics will be performed with the sensor indwelling in the bladder after which the sensor will be removed.


Eligibility criteria: Inclusion Criteria:

* Male or female patient must be ≥ 18 years of age
* Patient must have a diagnosis of LUTD
* Patient must be scheduled for or recommended for cUDS
* Patient is able to tolerate 18Fr catheterization
* Patient or patient's legally authorized representative is able to provide informed consent

Exclusion Criteria:

* Pregnant (as confirmed by urine pregnancy test) or breastfeeding, pregnant within the past 6 months or intend to become pregnant during the study period.
* Patient has a symptomatic UTI based on CDC guidance (see below)
* Subjects who, at the principal investigator's determination, would not be appropriate for this study.

Primary outcomes:
measure: Insertion/Removal Success
timeFrame: during the procedure/surgery
measure: Device-related SAE
timeFrame: up to 2 weeks
Secondary outcomes:
measure: Patient perception
timeFrame: during the procedure/surgery
Other outcomes:
Locations:
city: Murrieta
country: United States
facility: Tri Valley Urology
state: California
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital Presbyterian
state: California
city: East Setauket
country: United States
facility: Stony Brook Medicine
state: New York
city: North Charleston
country: United States
facility: Palmetto Adult and Children's Urology
state: South Carolina
city: Arlington
country: United States
facility: Urology Partners of North Texas
state: Texas
Study officials:
References:
citation: Frainey BT, Majerus SJA, Derisavifard S, Lewis KC, Williams AR, Balog BM, Butler RS, Goldman HB, Damaser MS. First in Human Subjects Testing of the UroMonitor: A Catheter-free Wireless Ambulatory Bladder Pressure Monitor. J Urol. 2023 Jul;210(1):186-195. doi: 10.1097/JU.0000000000003451. Epub 2023 Jun 9.
Clinical trial NCT01011855: Radiant Warmer Trial
Official title: A Comparison of Thermal Responses Among Newborns to Proportional Versus Adaptive Heating Algorithms in Radiant Warmer Devices
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Body Temperature Changes
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
First posted: 2009-11-11
Enrollment: 0
Sex: ALL
Minimum age (years): 32
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to compare three radiant warmer beds that contain different computer heating software and different bed styles. Radiant warmers are used in many neonatal intensive care units (NICU) to provide heat to infants to help regulate an infant's temperature. It is common for babies to require care on an open bed that provides heat to the baby according to the baby's needs and at the same time allows easy access to the baby for care and necessary procedures. There are different styles of beds, each with unique computer software that can guide how a bed's heater output is automatically adjusted according to a baby's temperature needs. It is unknown which style of bed or method of heating might be best. This study seeks to evaluate infant responses to three different types of radiant warmer beds.

Detailed description: Study was withdrawn

Eligibility criteria: Inclusion Criteria:

* Any baby \> 32 weeks gestation and \> 1500 grams that requires initial care on a radiant warmer during confinement in the neonatal intensive care unit.

Exclusion Criteria:

* Any baby who has a skin condition that may prevent or compromise thermistor placement and interfere with accurate temperature readings from thermistors or IR camera.
* Any baby who is deemed too sick to tolerate movement from one radiant warmer to another by the attending physician.
* Any baby who has a medical condition or anomaly that contraindicates axillary or abdominal temperature measurements

Primary outcomes:
measure: Abdominal skin surface temperatures and axillary temperatures under 3 radiant warmer conditions as measured by skin thermistors and infrared thermography (IRT).
timeFrame: There is a 4-hour baseline/washout period, followed by a 20-hour data collection cycle that will be repeated for all three-treatment conditions. Samples from the bed and telethermometer will be collected electronically every 60 seconds.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Christiana Care
name: Wendy Sturtz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01074255: Re-examination Study of EMEND (Aprepitant) (MK-0869-184)
Official title: Re-examination Study For General Drug Use to Assess the Safety and Efficacy Profile of EMEND in Usual Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chemotherapy-induced Nausea and Vomiting
Keywords: Nausea
Vomiting
Chemotherapy
Post-chemotherapy
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2010-02-24
Enrollment: 3546
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Korean patients treated with EMEND in usual practice.

Brief summary: This survey is conducted for preparing application materials for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation. Its aim is to reconfirm the clinical usefulness of EMEMD (aprepitant) through collecting the safety information according to the Re-examination Regulation for New Drugs.


Eligibility criteria: Inclusion Criteria:

* Participants who are treated with EMEND for the first time as per the EMEND label

Exclusion Criteria:

* Contraindication to EMEND

Primary outcomes:
measure: Investigator Global Assessment of Participants' Response to Therapy With EMEND (Aprepitant) for the Prevention of Acute and Delayed Nausea Following Chemotherapy
timeFrame: Up to 14 days following the cessation of treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03130855: Comparison Between Efficiency of Inferior Alveolar Nerve Block and Buccal Infiltration Techniques Using Articaine 4% 1:100000
Official title: Buccal Infiltration Technique Compared to Inferior Alveolar Nerve Block Technique for Alleviation of Intraoperative Pain During Pulpal Treatment of Mandibular Primary Molars: A Randomized Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anesthesia, Local
Keywords: pediatric patients
articaine local anesthesia
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-04-27
Enrollment: 48
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This split mouth randomized control trial is designed as to compare the effectiveness of the buccal infiltration technique with the gold standard inferior alveolar nerve block in anesthetizing mandibular second primary molars to undergoing pulpal treatment.

patient will be videotaped during pulpal treatment of their teeth and an accessing pain will be through an objective pain scale (SEM scale), (sound-eye-motor scale).

the patient will be asked to fill in a subjective Wong Baker pain scale for the pain suffered during injecting the local anesthetic agent in both techniques.


Eligibility criteria: A-Inclusion Criteria:

1. first dental visit.
2. cooperative children (rating 4 or 3 based on Frankl behavior scale) aging from 6 to 8 years suffering from one or more deep carious lesions in their primary molars seeking treatment.
3. Restorable molars with stainless steel crowns.

B-Exclusion Criteria:

1. medically compromised patients. uncooperative children (rating 1 or 2 on the Frankl behavior scale)needing special line of treatment through general anesthesia.
2. signs and symptoms of irreversible pulpitis, spontaneous pain, necrosis or any signs or symptoms of any infection.
3. presence of any radiographic signs of abcess, bone loss, internal or external root resorption.
4. parents or guardians who refuse participating in the study.

Primary outcomes:
measure: pain experienced by child during pulpal treatment
timeFrame: one week
Secondary outcomes:
measure: time needed for numbness
timeFrame: one week
measure: pain experienced by the child due to needle prick
timeFrame: one week
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00867555: Green Tea, High in Epigallocatechin Gallate (EGCG) and Postprandial Fat Oxidation
Official title: Effects of the Green Tea Extract TEAVIGO High in EGCG, on Postprandial Fat Oxidation in Overweight Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Type 2 Diabetes Mellitus
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: DSM Nutritional Products, Inc.
First posted: 2009-03-24
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The body of evidence regarding the health benefits of green tea has grown considerably during the last decade and includes antioxidant properties, anti- cancer, anti-obesity and anti-diabetes effects. There has been evidence that green tea extract favorably affect body weight and body fat and has positive effects on blood glucose control

Aim of this study is to investigate the short term effect (3-day)of TEAVIGO (high in the catechin EGCG) on postprandial fat oxidation during different phases of the postprandial period in overweight subjects. Secondly, in a subset of volunteers changes in lipolysis and glucose metabolism will be studied in skeletal muscle and adipose tissue.


Eligibility criteria: Inclusion Criteria:

* Age between 20 and 50 y
* BMI 25.0-29.9 kg/m2
* Normal fasting glucose \<6.1 mmol/L
* Blood pressure (systolic blood pressure 100-150 mmHg, diastolic blood pressure 60-90 mmHg)
* Weight stable in last 3 months (±2 kg)

Exclusion Criteria:

* pregnant, lactating or (post)menopausal women
* regular smokers
* people with intensive fitness training eg athletes
* habitual consumption of green or black tea (more than 1 or 2 cups a day, respectively)
* not more than 300 mg/day caffeine consumption

Primary outcomes:
measure: postprandial fat oxidation
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Dept Human Biology, Maastricht University
Study officials:
affiliation: Maastricht University
name: Ellen E Blaak, PhD, Prof
role: PRINCIPAL_INVESTIGATOR
References: