louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05925738: Deep Learning Signature for Predicting Aggressive Histological Pattern in Resected Non-small Cell Lung Cancer
Official title: Positron Emission Tomography/ Computed Tomography (PET/CT) Based Deep Learning Signature for Predicting Aggressive Histological Pattern in Resected Non-small Cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non-small Cell Lung Cancer
Spread Through Air Space
Visceral Pleural Invasion
Lymphovascular Invasion
Lead sponsor: Shanghai Pulmonary Hospital, Shanghai, China
Sponsor class: OTHER
Collaborators: name: Ningbo No.2 Hospital
name: Zunyi Medical College
name: The First Affiliated Hospital of Nanchang University
First posted: 2023-06-29
Enrollment: 1500
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Resected Stage I-III Non-small Cell Lung Cancer

Brief summary: The purpose of this study is to evaluate the performance of a PET/ CT-based deep learning signature for predicting aggressive histological pattern in resected non-small cell lung cancer based on a multicenter prospective cohort.


Eligibility criteria: Inclusion Criteria:

(1) Participants scheduled for surgery for radiological finding of pulmonary lesions from the preoperative thin-section CT scans; (2) Pathological confirmation of primary NSCLC; (3) Age ranging from 20-75 years; (4) Obtained written informed consent.

Exclusion Criteria:

(1) Multiple lung lesions; (2) Poor quality of PET-CT images; (3) Participants with incomplete clinical information; (4) Participants who have received neoadjuvant therapy.

Primary outcomes:
measure: Area under the receiver operating characteristic curve
timeFrame: 2023.5.1-2023.10.31
Secondary outcomes:
measure: Sensitivity
timeFrame: 2023.5.1-2023.10.31
Other outcomes:
measure: Specificity
timeFrame: 2023.5.1-2023.10.31
measure: Positive predictive value
timeFrame: 2023.5.1-2023.10.31
measure: Negative predictive value
timeFrame: 2023.5.1-2023.10.31
measure: Accuracy
timeFrame: 2023.5.1-2023.10.31
Locations:
city: Zunyi
country: China
facility: Affiliated Hospital of Zunyi Medical University
state: Guizhou
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Ningbo
country: China
facility: Ningbo HwaMei Hospital
state: Zhejiang
Study officials:
References:
Clinical trial NCT02232438: Psychotherapy for Depressed or Anxious Adolescents With Cancer
Official title: Open Trial of Behavioral Activation Therapy for Depressed or Anxious Adolescents With Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Depression
Anxiety
Cancer
Keywords: Depression
Psychotherapy
Anxiety
Cancer
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
First posted: 2014-09-05
Enrollment: 0
Sex: ALL
Minimum age (years): 12
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: At present, there are no established treatments for depression or anxiety in adolescents with cancer, creating an important clinical and research gap. Fortunately, there is now substantial evidence documenting the efficacy of psychotherapy in the treatment of depressed and anxious adolescents in the general population.

Detailed description: Despite the high prevalence of depression and anxiety in cancer patients, little is known about the efficacy of psychotherapy in depressed and anxious adolescents with cancer.

Behavioral activation therapy (BAT) is a brief, manualized therapy that has shown efficacy in the treatment of major depressive disorder (MDD) and generalized anxiety disorder (GAD) in several controlled trials patients, including adult cancer patients. The goal of this open label clinical trial is to obtain preliminary evidence of the efficacy of BAT(6 sessions) in a group of adolescent cancer patients with MDD, GAD or adjustment disorder with mood or anxiety features.

We will test the efficacy of BAT using the Multidimensional Anxiety Scale for Children at several time points of the treatment.

Eligibility criteria: Inclusion Criteria:

* A primary psychiatric diagnosis of Major Depressive Disorder, Generalized Anxiety Disorder or Adjustment Disorder with Mood or Anxiety features as defined by DSM-IV.
* Cancer patients.
* Parent consent and child assent to participate for patients younger than 18. Patient consent for subjects 18-21.
* Diagnosis of cancer (stage 1-4), but healthy enough to complete study procedures.

Exclusion Criteria:

* Lifetime history of psychosis or bipolar disorder.
* Current suicide risk.
* History of substance abuse or dependence in the three months prior to the study.
* Patients who have ever failed BAT in the context of cancer.
* Receiving other concurrent therapy for same disorder and patients who are receiving effective medication for depression.
* Mental retardation.
* CNS tumors.
* Patients undergoing Stem Cell Transplantation.

Primary outcomes:
measure: Change in Multidimensional Anxiety Scale for Children (MASC 2)
timeFrame: baseline, and every two weeks till week 10
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
References:
Clinical trial NCT03547843: The Effects of Peer Co-led Educational Group Intervention for Adults With Attention-Deficit Hyperactivity Disorder
Official title: The Effects of Peer Co-led Educational Group Intervention for Adults With Attention-Deficit Hyperactivity/Impulsivity Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Disorder With Hyperactivity
Keywords: Behavior therapy
Peer groups
Patient satisfaction
Feasibility studies
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2018-06-06
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Pilot randomized clinical trial
Primary purpose: OTHER

Brief summary: Peer co-led education describes educators who are expert patients, user representatives or former patients, participating and teaching in educational interventions in cooperation with health care professionals. Peer co-led education is included in the Norwegian national guidelines for treatment of mental disorders, but despite some promising results for the treatment of other conditions, still little is known about the efficacy of peer co-led educational group interventions interventions for adults with attention deficit and hyperactivity disorder (ADHD).

This pilot trial will evaluate patient satisfaction with and preliminary efficacy of a 2-session peer co-led educational group program designed to address specific challenges faced by adults diagnosed with ADHD at an outpatient clinics in mid-Norway.


Eligibility criteria: Inclusion Criteria:

* Confirmed ADHD-diagnosis
* speaking a Scandinavian language

Exclusion Criteria:

* Unable to give informed consent
* Psychosis
* Severe learning difficulties

Primary outcomes:
measure: Change in client Satisfaction
timeFrame: from baseline to 2-weeks follow-up
measure: change in patient activation
timeFrame: from baseline to 10-weeks follow-up
Secondary outcomes:
measure: change in general self-efficacy
timeFrame: from baseline to 10 weeks follow-up
measure: change in ADHD-related symptoms
timeFrame: from baseline to 10 weeks follow-up
measure: change in ADHD-related symptoms
timeFrame: from baseline to 10 weeks follow-up
measure: change in Quality of Life
timeFrame: from baseline to 10 weeks follow-up
Other outcomes:
measure: Use of health services and work participation
timeFrame: through study completion, an average of 24 weeks
Locations:
city: Trondheim
country: Norway
facility: Tiller DPS
Study officials:
affiliation: St. Olavs Hospital
name: Anne-Lise Løvaas, md phd
role: STUDY_DIRECTOR
References:
Clinical trial NCT01138943: Chlorhexidine Mouthrinses and Plaque Control
Official title: Chlorhexidine Alcohol Base Mouthrinse Versus Chlorhexidine Formaldehyde Base Mouthrinse Efficacy on Plaque Control: Double Blind, Randomized Clinical Trials
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Plaque
Keywords: Chlorhexidine mouthrinse
Plaque control
Lead sponsor: Hôpital Militaire De Rabat
Sponsor class: OTHER
Collaborators: name: CCTD, Centre Hospitalier Ibn Sina,Morocco
name: Faculté de Médecine Dentaire de Rabat
name: Faculté de Médecine de Rabat
name: Mohammed V Souissi University
First posted: 2010-06-08
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of the present study was to compare antiplaque effectiveness of two commercial mouthrinses: 0.12 % Chlorhexidine alcohol base (CLX-A) versus a diluted 0.1% Chlorhexidine non-alcohol base with 0.1% of Formaldehyde (CLX-F).

Detailed description: Chlorhexidine (CLX) mouthrinse has been the gold standard as antiplaque solution.However, if its efficiency seems to be preserved even if the chlorhexidine concentration is bellow 0.10%, the formulation of the final product may affect the effectiveness. Thus, it can be concluded from this study that 0.12% CLX alcohol base mouthrinse is significantly more effective in inhibiting plaque than the diluted 0.1% CLX non-alcohol base containing formaldehyde mouthrinse.

Eligibility criteria: Inclusion Criteria:

* give written informed consent before entering the study
* accept to stop tooth cleaning for a week

Exclusion Criteria:

* less than 20 teeth;
* presence of periodontal disease
* presence of factors of plaque retention (clinically unacceptable restorations, important carious, dental overlapping, removable prosthesis, faulty fixed prosthesis, orthodontic appliances),
* associated systemic diseases (diabetes, heart disorders, blood diseases, HIV infection),
* use of antibiotics or other anti-inflammatory drugs during the latest months,
* known allergy against components of mouth rinses,
* pregnancy,
* smoking

Primary outcomes:
measure: Plaque Index (PI)at Day 1 and Day 7.
timeFrame: one week
Secondary outcomes:
measure: Side effects
timeFrame: at day 7
Other outcomes:
Locations:
city: Rabat
country: Morocco
facility: Faculté de Médecine Dentaire
Study officials:
affiliation: Faculté de Médecine Dentaire
name: Oumkeltoum Ennibi, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT03554343: Sun May Arise on SMA : Newborn Screening of Spinal Muscular Atrophy in Belgium
Official title: Sun May Arise on SMA : Newborn Screening of SMA in Belgium
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Muscular Atrophy
Keywords: newborn screening
Lead sponsor: Centre Hospitalier Régional de la Citadelle
Sponsor class: OTHER
Collaborators: name: AveXis, Inc.
name: Biogen
name: Roche Pharma AG
name: Association Belge contre les Maladies neuro Musculaires
First posted: 2018-06-13
Enrollment: 136339
Sex: ALL
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All newborns

Brief summary: Medico-economic study of Newborn screening of Spinal Muscular Atrophy

Detailed description: The aim of this project is to demonstrate the feasibility and the medico-economic impact of a spinal muscular atrophy neonatal screening in a European country. We propose a 3-year-neonatal screening program in Southern Belgium (Wallonia-Brussels Federation) where there is 59.000 newborns/year, among whom 6 are affected by spinal muscular atrophy.

Eligibility criteria: Inclusion Criteria:

* All newborns in southern Belgium

Exclusion Criteria:

* Newborns whose parents refuse screening

Primary outcomes:
measure: Cases detected
timeFrame: march 2018-March 2021
Secondary outcomes:
measure: Incidence of SMA
timeFrame: March 2018-March 2021
Other outcomes:
Locations:
city: Liege
country: Belgium
facility: CRMN, Hôpital La Citadelle
state: Wallonia
Study officials:
affiliation: CRMN
name: Laurent Servais, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Boemer F, Caberg JH, Dideberg V, Dardenne D, Bours V, Hiligsmann M, Dangouloff T, Servais L. Newborn screening for SMA in Southern Belgium. Neuromuscul Disord. 2019 May;29(5):343-349. doi: 10.1016/j.nmd.2019.02.003. Epub 2019 Feb 15.
Clinical trial NCT01638143: Bio-equivalence Study
Official title: Comparison of Bioavailability of Three Different Vitamin K2 Formulations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bioequivalence
Bioavailability
Keywords: vitamin K2
menaquinone-7
bioavailability
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2012-07-11
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to compare absorption of vitamin K2 (menaquinone-7) after intake of three different vitamin K2 supplements.

Detailed description: Several manufacturers are producing vitamin K2 raw material in different forms, namely oil and powder. To ensure bioequivalence of different vitamin K2 sources, the investigators are interested to compare the bioavailability of three different vitamin K2 formulations that are already commercially available. Two different oils and one powder product will be compared in this randomized cross-over trial. The investigators hypothesize that different vitamin K2 sources give no differences in bioavailability of vitamin K2.

Eligibility criteria: Inclusion Criteria:

* Healthy men and women, aged between 20 and 40 years
* Normal body weight and height (18.5 kg/m2 \< BMI \< 30 kg/m2)
* Stable body weight (weight gain or loss \< 3 kg in past 3 mo)
* Written consent to take part in the study
* Agreement to adhere to dietary restrictions required by the protocol

Exclusion Criteria:

* Abuse of drugs and/or alcohol
* Use of vitamin supplements containing vitamin K
* Soy allergy
* Pregnancy
* a history of) metabolic or gastrointestinal diseases including hepatic disorders
* Chronic degenerative and/or inflammatory diseases, e.g. diabetes mellitus, renal failure
* Use of oral anticoagulants
* Corticoid treatment
* Subjects with anaemia or subjects who recently donated blood or plasma
* Systemic treatment or topical treatment likely to interfere with coagulation metabolism (salicylates, antibiotics)

Primary outcomes:
measure: MK-7 absorption profiles
timeFrame: 9 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: VitaK BV / Maastricht University Medical Center
Study officials:
affiliation: VitaK BV Maastricht University
name: Cees Vermeer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00963443: Acetylsalicylic Acid Combined With Pseudoephedrine in Common Cold
Official title: A Double Blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Acetylsalicylic Acid Combined With Pseudoephedrine, Compared With Acetylsalicylic Acid Alone, and Pseudoephedrine Alone, on Symptoms of Pain.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Common Cold
Keywords: Aspirin Complex
Acetylsalicylic Acid
Pseudoephedrine
Common Cold
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-08-21
Enrollment: 833
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine the effectiveness of an acetylsalicylic acid (aspirin) pseudoephedrine combination for the treatment of pain and congestion symptoms compared to the effectiveness of the individual components of the medicine and the placebo (dummy treatment that looks like the real thing).The combination product of acetylsalicylic acid / pseudoephedrine is already marketed in several European countries as Aspirin® Complex.


Eligibility criteria: Inclusion Criteria:

* Patient in general good health with suspected viral upper respiratory tract infection (common cold)

Exclusion Criteria:

* \< 18 years old

Primary outcomes:
measure: Reduction of nasal congestion and relief of pain
timeFrame: 4 hours
Secondary outcomes:
measure: Area under the curve for nasal airflow conductance from baseline
timeFrame: 1h, 2h, 3h
measure: Sum of subjective nasal congestion intensity differences
timeFrame: 1h, 2h, 3h, 4h and 1, 2, 3 days
measure: Total subjective nasal congestion relief
timeFrame: 1h, 2h, 3h,4 h and 1, 2, 3 days
measure: Global assessment of nasal congestion
timeFrame: 3 days
measure: Global assessment of pain relief
timeFrame: 3 days
measure: Sum of pain intensity differences
timeFrame: 1h, 2h, 3h, 4h and 1, 2, 3 days
measure: Total pain relief
timeFrame: 1, 2, 3 days
measure: Adverse Event collection and physical examination
timeFrame: 3 days
Other outcomes:
Locations:
city: Cardiff
country: United Kingdom
state: South Glamorgan
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06324643: Sensory Motor Integration Training in Erb's Palsy Childern
Official title: Effect of Sensory Motor Training on Activities of Daily Living in Erb's Palsy Childern
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sensory Motor Integration and Erb's
Keywords: Erb's palsy -sensory motor integration - ADL- Bimanual hand use
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2024-03-22
Enrollment: 35
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to Study effect of sensory motor integration training on ADL activities in children with Erb's palsy.

Detailed description: Thirty-two participants , their age ranged from two to six years for both genders (sixteen children treated with designed occupational therapy program group A and sixteen treated with designed occupational therapy program and sensory motor integration training group B )

Eligibility criteria: Inclusion Criteria:

1. Their ages will be ranged from 2 to 6 years in both sexes.
2. The infants with Erb's palsy (C5-C6).
3. Can follow verbal commend
4. Muscle tone within normal and muscle power within functional range.
5. Intact vision and hearing.

Exclusion Criteria:

1. Children undergoing surgical treatment.
2. Cognitive problem and cognitive anomalies.
3. Children with Erb's engram.
4. Complete sensory loss.
5. Shoulder subluxation or dislocation.

Primary outcomes:
measure: Effect of sensory motor integration training on ADL
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Kafrelsheikh University
name: Sara Elsayed ali abdelnaby, Bachelor's
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor of pediatric department- Faculty of physical therapy- kafrelsheikh university
name: Abd Elaziz Ali sherif
role: STUDY_CHAIR
affiliation: professor and head of department of pedateric-faculty of medicine -kafrelsheik university
name: Osama Abd Elfattah El-Agamy
role: STUDY_CHAIR
affiliation: Lecturer of pediatric department -Faculty of physical therapy- Kafrelshiekh University
name: Sara Yousef Abdel Elglil Elsebahy
role: STUDY_DIRECTOR
References:
Clinical trial NCT03810443: Prevalence of the Hyperventilation Syndrome in Pulmonary Arterial Hypertension
Official title: Prevalence of the Hyperventilation Syndrome in Pulmonary Arterial Hypertension
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pulmonary Arterial Hypertension
Keywords: Hyperventilation
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2019-01-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Dyspnea is a major symptom in pulmonary arterial hypertension and people with the same haemodynamic have generally different degree of dyspnea in pulmonary arterial hypertension. The hyperventilation syndrome is a frequent cause of dyspnea in general population and in respiratory diseases like asthma but has never been studied in pulmonary hypertension. The goal of this study is to measure the prevalence of pulmonary hypertension in a population of patients with controlled pulmonary arterial hypertension (PAH).

Detailed description: Hyperventilation syndrome has been described as a cause of dyspnea in the general population and in several chronic respiratory diseases such as asthma with 20 to 40% of asthmatics affected. However, Hyperventilation syndrome has never been sought in a population with PAH. Hyperventilation syndrome, although complex pathophysiology, may be simply corrected by a management of respiratory physiotherapy based on the control of respiration.

Eligibility criteria: Inclusion Criteria:

* Non smoker or tobacco stopped for minimum 2 years ans maximum 10 year-pack. - Idiopathic, heritable, related to drug or toxics, associated with controlled pulmonary hypertension. Diagnosis and treatment of pulmonary hypertension for more than 4 months.
* Optimal control of pulmonary hypertension (no right heart failure symptom and NTproBNP \< 300ng/L or Brain Natriuretic Peptide(BNP) \< 50 ng/L and optimal hemodynamic results measured by a right heart catheterization in the last year: right atrial pressure \< 8 mmHg, cardiac index \> 2,5 L/min/m2, veinous saturation in oxygen \> 65%)
* Informed and written consent
* Non-affiliation to a social security

Exclusion Criteria:

* Existence of another form of pulmonary hypertension
* Existence of vocal cord dysfunction
* Pregnancy
* Obesity\> stage 2 (BMI 35 kg / m2)
* Age ≥ 75 years

Primary outcomes:
measure: Prevalence of the hyperventilation syndrome
timeFrame: 18 months
Secondary outcomes:
measure: anxiety-depression questionary score
timeFrame: 18 months
measure: dyspnea score
timeFrame: 18 months
measure: quality of life score
timeFrame: 18 months
Other outcomes:
Locations:
city: Le Kremlin-Bicêtre
country: France
facility: Hôpital Bicêtre - Pneumology department
Study officials:
affiliation: APHP
name: Etienne-Marie JUTANT, CCA
role: PRINCIPAL_INVESTIGATOR
References: