louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01435850: Safety and Efficacy of the SL PLUS and the SL PLUS MIA Hip Stem
Official title: "Enfoncement de la Tige SL-PLUS et de la Tige SL-PLUS MIA:Etude Comparative"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coxarthrosis
Keywords: hip arthroplasty
primary stability
secondary stability
EBRA
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2011-09-19
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Randomized controlled trial using two types of hip stems, SL PLUS MIA (control group) and SL PLUS (study group).

We compare primary and secondary stability of both hip stems for radiographic outcome using EBRA (Ein-Bild-Roentgen-Analyse) after a two year follow-up period.

Further, we compare all differences in clinical outcome using Harris Hip Score, Oxford hip score and radiographic findings.

Detailed description: This study is a monocentric study, randomized and controlled including two types of hip stems: SL PLUS MIA (control group) and SL PLUS (study group).

Each group will include 45 patients where a number of 5 patients for each group calculated extra in case of loss.

Patients will be followed after

* 6 weeks
* 6 months
* 12 months
* 24 months. Radiographs are taken in a-p and lateral view using a standard protocol. Primary and secondary stability of both hip stems will be analyzed using the EBRA software (Ein-Bild-Roentgen-Analyse, University of Innsbruck, Austria) after the completion of the two year follow-up.

Further, we compare all differences in clinical outcome using Harris Hip Score, Oxford hip score and radiographic findings such as radiolucent lines.

Eligibility criteria: Inclusion Criteria:

* Patient needs primary total hip arthroplasty with SL-PLUS (standard or lateralized depending on bone morphology)
* Age at surgery : 18-80 years old
* Patient has social security number
* Patient gives Informed Consent (IC) by signing the IC form and patient is willing to attend the follow-up control

Exclusion Criteria:

* Patient's BMI is over 35
* Patient has bone tumors that can affect implant stability
* Patient needs cortical steroid treatment
* Patient needs hip revision arthroplasty
* Patient has general inflammation that could affect bone quality
* Patients classified Charnley C

Primary outcomes:
measure: Stability of primary total hip arthroplasty
timeFrame: 24 months
Secondary outcomes:
measure: Oxford Hip Score
timeFrame: 24 months
measure: Harris Hip Score
timeFrame: 24 months
Other outcomes:
Locations:
city: Lille Cedex
country: France
facility: Hopital Salengro, Service d'Orthopédie C
Study officials:
affiliation: University Hospital
name: Henri Migaud, MD, Pr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00042250: IUdR/BUdR Cell Cycle Labelling
Official title: Cell Cycle Kinetics in Vivo in Patients With Hematologic Malignancies Studied by Iododeoxyuridine and Bromodeoxyuridine Labelling
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hematologic Malignancies
Keywords: Cell Cycle Interphase
G0
G1
G2
S Phase
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2002-07-26
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To determine cell cycle parameters and changes after treatment, the labelling agent is given and a bone marrow aspiration is accomplished before treatment and after treatment for comparison. Participants must be undergoing concurrent therapy for hematologic malignancy.

Detailed description: Cell cycle parameters include LI, Ts, Tc, T dpot, changes in these parameters, and differences between normal and leukemic cells in patients with hematologic malignancy prior to and following treatment.

Eligibility criteria: Histologic proof of one of:

* AML, ALL, or AUL
* MDS or CMML
* CML
* OR undergoing bone marrow transplantation.

Participants should be:

* off therapy for at least two weeks
* At least 18 years old or older
* Using adequate contraception if of child-bearing capability.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M.D. Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Michael Andreeff, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01733550: ICare Self-tonometry - A Head-to-head Comparison to the Gold Standard Goldmann Tonometer
Official title: ICare Self-tonometry - A Head-to-head Comparison to the Gold Standard Goldmann Tonometer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Glaucoma
Keywords: Intraocular Pressure
Tonometry, Ocular
iCare
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2012-11-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Glaucoma patients who are admitted to the hospital for repeated eye pressure measurements learn how to handle the home i care during their stay.

Brief summary: The purpose of this study is to compare glaucoma patients' own I Care measurements by the standard Goldmann applanation tonometer intraocular pressure (IOP) measurements.

Detailed description: not necessary

Eligibility criteria: Inclusion Criteria:

* Ocular hypertension (OHT):with/without glaucoma drugs
* Primary open angle glaucoma (POAG)- high pressure: Diagnosis based on optic nerve head rim loss and/or visual field defects and intraocular pressure (IOP) \>21 mmHg.
* Primary open angle glaucoma, normal pressure: cfr high pressure but intraocular pressure ≤ 21 mmHg
* Exfoliative Glaucoma (PEX): Diagnosis based on optic nerve head rim loss and/or visual field defects and intraocular pressure (IOP) \>21 mmHg, with exfoliation material in the anterior segment.
* Pigmentary Glaucoma (PDG): Diagnosis based on optic nerve head rim loss and/or visual field defects and intraocular pressure (IOP) \>21 mmHg, with Krukenberg's spindle and/or pigment dispersed on the trabecular meshwork.

Exclusion Criteria:

* Age \<18 years
* Other glaucoma types
* Corneal pathology (edema, dystrophia, corneal transplantation, severe keratoconus, permanent contact lens wear, recurrent corneal erosion)
* Severe arthritis (unable to handle home i care device)
* Lack of comprehension
* Intra ocular surgery and laser treatment during the last 6 months

Primary outcomes:
measure: Intra-ocular pressure with Home ICare and Goldmann Applanation Tonometer.
timeFrame: immediate comparison, no time frame required
Secondary outcomes:
measure: Patient Comfort
timeFrame: 1 day hospitalisation
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZLeuven
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Ingeborg Stalmans
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00165750: Correlation Between Regional Brain Volume and Response to Donepezil Treatment in AD Patients
Official title: Correlation Between Regional Brain Volume and Response to Donepezil Treatment in AD Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Alzheimer's Disease
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2005-09-14
Enrollment: 40
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study investigate the relationship between regional brain volume measured by MRI and donepezil treatment response in patients with Alzheimer's Disease.


Eligibility criteria: Inclusion criteria:

1. Over 60 years old.
2. Probable or possible Alzheimer's Disease according to the DSM-IV and NINCDS-ADRDA.
3. MMSE score of 10\~24, CDR of 1\~2.
4. Patients didn't take acetylcholinesterase inhibitors 4 weeks before screening.
5. Permitted drugs: antipsychiatric drug for BPSD, antidepression drug, tranquilizer, treatment drug for physical disease for example hypertension.

Exclusion criteria:

1. Uncontrolled by donepezil because of adverse events.
2. No longer continuing treatment of donepezil for refuse, drug-drug interaction etc.
3. If they have taken concomitant medication which were not allowed.

Primary outcomes:
measure: MRI, ADAS-cog
timeFrame: 0, 12, 24 weeks
Secondary outcomes:
measure: ADL, BPSD, CDR-SB, ZBI, GHQ, CIBIC plus
timeFrame: 0, 12, 24 weeks
Other outcomes:
Locations:
city: Gwangju
country: Korea, Republic of
facility: Cheonnam University Hospital
Study officials:
affiliation: Eisai Korea Inc.
name: Jihee Mun
role: STUDY_DIRECTOR
References:
Clinical trial NCT03964350: Behavior Brain Responses
Official title: Behavior and Brain Responses to Drugs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Alcohol Drinking
Drinking Behavior
Physiological Effects of Drugs
Central Nervous System Depression
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2019-05-28
Enrollment: 30
Sex: MALE
Minimum age (years): 21
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: To compare responses to acute oral doses of ethanol in healthy young adults who experience mainly stimulant subjective effects from the drug or mainly sedative effects.


Eligibility criteria: * 21-35 years old
* 4-30 alcoholic drinks per week (as reported on PHQ or TLFB)
* No 'flushing' reaction to alcohol
* BMI 19-26
* High school education or greater, fluent in English
* No night shift work
* No current or past year Axis I psychiatric disorder including drug/alcohol dependence
* No current psychopharmacological treatment
* No lifetime ADHD or prescription for ADHD medication
* No abnormal EKG, cardiovascular illness, high blood pressure
* No medical condition or pharmacological treatment for which alcohol is contraindicated
* Not pregnant, lactating, or planning to become pregnant
* Smoke \<6 cigarettes per day

Primary outcomes:
measure: Change in Subjective Effects as Assessed by Score on "Feel Drug", "Feel High", "Like Drug", and "Want More" Subscales of the Drug Effects Questionnaire Across Sessions
timeFrame: At expected peak drug effect (30 min post drink administration)
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Harriet de Wit
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02045550: Tolerance and Effect of a Prophylactical Treatment With Ivy Leaves Dry Extract in Recurrent Wheezy Bronchitis
Official title: Tolerance and Effect of a Prophylactical Treatment With a Cough Medicine Con-taining Ivy Leaves Dry Extract in Children With Recurrent Wheezy Bronchitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Acute Wheezy Bronchitis
Recurrent Bronchitis
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
First posted: 2014-01-27
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To evaluate the effect of a prophylactical therapy with a cough medicine containing ivy leaves dry extract on the frequency of recurrent wheezy bronchitis in toddlers, on the duration of the bronchitis episodes, on the severity and the additional drug demand. A prolonged asymptomatic episode between each wheezy bronchitis due to the therapy is assumed.


Eligibility criteria: Inclusion Criteria:

1. Medical diagnosis of ≥3 episodes of wheezy bronchitis within the pre-vious 12 months
2. Children aged from 1 to 3 years (girls and boys)
3. Signed Informed Consent of the legal guardians to participate in the trial after written and verbal briefing by the Investigator
4. No allergic sensitization
5. Allowance to contact the familys pediatrician for medical history of wheezy bronchitis episodes

Exclusion Criteria:

1. Anamnestically known intolerance/allergy to one of the drugs applied or to their ingredients or to drugs of similar chemical structure
2. Participation of the patient in another clinical trial within the last four weeks before enrollment in this trial
3. Evidence suggesting that the patient or their legal representative is not likely to follow the trial protocol (e.g. lacking compliance)
4. Inability to document the symptoms in a symptom log book or ques-tionnaire; inability to take the trial medication properly
5. Any regular therapy except Vitamin D or Fluoride
6. Chronic illnesses of different aetiology
7. Premature birth or diagnosis of bronchopulmonary dysplasia
8. Gastro-oesophageal reflux
9. Hereditary fructose intolerance

Primary outcomes:
measure: the time to event (next bronchitis episode) rate during and after treatment period
timeFrame: three months
Secondary outcomes:
measure: days and percentage of days without bronchitis during and after treatment period
timeFrame: 3 months
measure: days and percentage of days without bronchitis during treatment period
timeFrame: three months
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Kinder- und Jugendmedizin
state: Saxonia
Study officials:
affiliation: Technische Universität Dresden
name: Christian Vogelberg, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05729750: Efficacy of Music Listening to Shortening Time for Biophysical Profile
Official title: Efficacy of Music Listening to Shortening Time for Biophysical Profile
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fetal Status, Nonreassuring
Keywords: Fetal biophysical profile
Music
Duration
Lead sponsor: Queen Savang Vadhana Memorial Hospital, Thailand
Sponsor class: OTHER
First posted: 2023-02-15
Enrollment: 60
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: the participants were purpostive sampling, and devided into two groups. The study group listening to music before and suring the assessment while the control gruop will not listening to music.
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this clinical trial is to compare the timeing which assume for assesment of BPP in low risk pregnancy. The main question is the music can be shoetening the timing for BPP? Participants will in study froup will listening the music via headphone before and during the assessment and compre to control gruop which not listening to music during asseeement.

Detailed description: A single-blind randomized controlled trial conducted from February 2021 to December 2022. The study population consisted of 60 pregnant women with between 18 and 35 years old with gestational age of 32 weeks. An abdominal ultrasound was performed while listening to one song while wearing headphones in the experimental group preceding the biophysical profile assessment. As part of the control group, the same equipment was used and the same assessment protocol was followed, but music was not played during the test.

Eligibility criteria: Inclusion Criteria:

* Single pregnancy (Singleton)
* Gestational age from 32 weeks onward
* Pregnant women do not have underlying diseases such as pre-gestational diabetes. high blood pressure
* No abnormalities in the fetus were found, such as fetal deformities.

Exclusion Criteria:

* Pregnant women receiving certain drugs or substances that affect the interpretation of the Biophysical Profile (BPP), e.g., sleeping pills, cigarettes.
* Pregnant women have hearing problems. or hearing impaired
* Pregnant women who are unable to wear headphones, e.g., otitis externa - Pregnant women with body mass index greater than 30 kg/m2 prior to pregnancy
* Uterine contractions were observed during the examination

Primary outcomes:
measure: Total time used for the biophysical profile
timeFrame: Through study complete, an average 30 minutes
Secondary outcomes:
measure: Satisfaction of music
timeFrame: After study complete, an average 30 minutes
Other outcomes:
Locations:
city: Chon Buri
country: Thailand
facility: Bhanubhan Meepon
state: Chonburi
Study officials:
References:
Clinical trial NCT03548350: School Based Physical Activity Interventions and Its Impact on Wellbeing and Educational Outcomes
Official title: School Based Physical Activity Interventions and Its Impact on Wellbeing and Educational Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Physical Activity
Health Behavior
Lead sponsor: Queen's University, Belfast
Sponsor class: OTHER
First posted: 2018-06-07
Enrollment: 1200
Sex: ALL
Minimum age (years): 8
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A school based Physical Activity intervention for pupils (8-9 years old) to promote fitness and wellbeing

Detailed description: The experimental group will participate in a 24 week multi-component programme that includes four strands:

* A physical literacy programme focusing on core elements of strength, agility, speed, balance and flexibility. Delivered by external facilitators for one hour per week over 16 weeks of the programme (2 x8week blocks).
* 'Golden Mile' - pupils and teachers participate 15min walk/run a min of 2 times per week
* After schools club (not compulsory) featuring mind-set component delivered by external facilitators
* Healthy kidz app with reward system

The control group will continue doing physical activity including physical education as is normal for their school

All groups will participate in fitness assessments at week 1 and week 24 of the programme and pupils will also complete questionnaires based on measures described above at week 1 and week 24.

Eligibility criteria: Inclusion Criteria:

* aged 8-9 years
* enrolled in participating school

Exclusion Criteria:

* Unable to give informed consent
* Presence of an underlying medical conditions
* Already enrolled in a physical activity intervention

Primary outcomes:
measure: Change in fitness
timeFrame: Baseline and week 24
measure: Change in health related quality of life measured by Kidscreen-10 quality of life and wellbeing in children
timeFrame: Baseline and week 24
measure: Physical activity behaviour measured by the Physical Activity Questionnaire for Children (PAQ-C)
timeFrame: Week 24
Secondary outcomes:
measure: Enjoyment of physical activity measured using the Shortened Physical Activity Enjoyment Scale (S-PACES).
timeFrame: Week 24
measure: Self efficacy measured by the Modified Physical Activity Self-Efficacy Scale (PASES)
timeFrame: Week 24
measure: Social support for physical activity measured by social support sub scale of the Social-Cognitive Measures for Physical Activity
timeFrame: Week 24
measure: Physical Self-perception measure by the Children's Physical Self-Perception Profile (CY-PSPP)
timeFrame: Week 24
Other outcomes:
Locations:
city: Belfast
country: United Kingdom
facility: Centre for Public Health, Queen's University Belfast
Study officials:
References:
Clinical trial NCT06984250: Hypofractionated Radiotherapy With Concomitant Tumor Bed Boost for Breast Cancer
Official title: Hybrid Techniques Combining Hypofractionated Whole Breast Radiotherapy With Concomitant Tumor Bed Boost in Patients With Breast Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Early Breast Cancer
Ductal Breast Carcinoma In Situ
Keywords: breast cancer
concomitant boost
tumor bed
Intensity-modulated radiation therapy
hypofractionated breast radiotherapy
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2025-05-22
Enrollment: 315
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Female patients diagnosed with early-stage breast cancer (T1-2 and N0-1) or ductal carcinoma in situ (DCIS) who are undergoing breast-conserving surgery.

Brief summary: Hypofractionated breast radiotherapy with concomitant tumor bed boost for early breast cancer or ductal breast carcinoma in situ after partial mastectomy


Eligibility criteria: Inclusion Criteria:

* Female patients with histologically confirmed early-stage breast cancer (T1-2 and N0-1) or ductal carcinoma in situ (DCIS).
* Patients undergoing breast-conserving surgery
* Age ≥ 20 years
* Karnofsky Performance Status (KPS) ≥70%
* Life expectancy ≥ 5 years
* Adequate renal and hepatic function

Exclusion Criteria:

* Pregnant patients
* Patients requiring re-irradiation of the thoracic region

Primary outcomes:
measure: Ipsilateral breast tumor recurrence
timeFrame: From enrollment to the end of treatment at 2 years
Secondary outcomes:
measure: Early Phase Acute Skin Toxicity
timeFrame: Up to 3 months following completion of radiotherapy
measure: Late Phase Breast Fibrosis
timeFrame: From 3 months up to 5 years following completion of radiotherapy
measure: Patient Quality of Life (EORTC QLQ-C30)
timeFrame: At baseline (before radiotherapy), between 1 week and 1 month following radiotherapy completion, then every 3 to 4 months thereafter until study completion (up to 5 years)
measure: Patient Quality of Life (EORTC QLQ-BR23)
timeFrame: At baseline (before radiotherapy), between 1 week and 1 month following radiotherapy completion, then every 3 to 4 months thereafter until study completion (up to 5 years)
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital Yunlin Branch
Study officials:
References: