louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02982785: Knee Replacement Outcome Predicted by Physiotherapists
Official title: Knee Replacement Outcome Predicted by Physiotherapists: A Prospective Cohort
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Total Knee Replacement
Osteoarthritis
Lead sponsor: Frederiksberg University Hospital
Sponsor class: OTHER
First posted: 2016-12-05
Enrollment: 364
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing primary total knee arthroplasty (TKA) for treatment of knee osteoarthritis. All patients from december 2016 to december 2017 will be invited to participate.

If it is not possible to reach the set sample size within the set timeframe, recruitment will continue until the numbers specified in the a priori sample size calculation are reached. Should the set sample size be reached ahead of time, recruitment will stop.

Brief summary: The aim is to assess if physiotherapists attending inpatients at elective orthopaedic wards can predict the future course (post hospitalisation) of recovery of patients undergoing KA. The prediction is made at hospital discharge using a 1-10 numerical rating scale (1=poor prognosis; 10=best prognosis).

To identify candidate prognostic factors, the therapist are asked to qualify their prognosis narratively, by listing at least 3-5 factors that they consider important for their projected prognosis score. There will be no maximum number of factors the physiotherapist can list.


Eligibility criteria: Inclusion Criteria:

1. Received primary knee replacement surgery for knee OA
2. Age ≥ 18 years
3. Reads and speaks Danish
4. Has an email address
5. Signed informed consent

Exclusion Criteria:

1. Cognitive impairments that preclude reliable answers to online questionnaires (e.g. dementia)
2. Revision surgery

Primary outcomes:
measure: Oxford Knee Score
timeFrame: 6 months after surgery
measure: Oxford Knee Score
timeFrame: 12 months after surgery
Secondary outcomes:
measure: Patient Acceptable Symptom State
timeFrame: 6 and 12 months after surgery
measure: EuroQoL questionnaire
timeFrame: 6 and 12 months after surgery
Other outcomes:
measure: Questionnaire regarding postoperative rehabilitation
timeFrame: 6 and 12 months after surgery
measure: Transition ratings of global perceived effect
timeFrame: 6 and 12 months after surgery
measure: Adverse events
timeFrame: 6 and 12 months after surgery
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital, Department of Physical and Occupational Therapy
city: Copenhagen
country: Denmark
facility: Gentofte Hospital, Department of Physical Therapy
Study officials:
affiliation: Department of Physical and Occupational Therapy, Bispebjerg-Frederiksberg Hospital
name: Marius Henriksen, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05987085: Medical Weight Loss on Pelvic Floor Dysfunction
Official title: Effect of Medical Weight Loss on Pelvic Floor Dysfunction: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Weight Loss
Pelvic Floor Disorders
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult women seeking medical weight loss

Brief summary: The goal of this observational study is to learn about the effect of medical weight loss on the symptom of pelvic floor dysfunction in obese and overweight women. The main question it aims to answer is: whether medical weight loss improves symptoms of pelvic floor dysfunctions in obese or overweight women.


Eligibility criteria: Inclusion Criteria:

* Age 18 or higher
* BMI 24 kg/m2 or higher
* Willing to follow the weight loss plan set by the physician follow-up and complete this study

Exclusion Criteria:

* Urinary tract infection or gynecologic reproductive system infection in the past month
* Treatment history of pelvic floor disorders
* Pregnancy or delivery in the past half year
* Women with severe systemic disease
* No follow-up conditions

Primary outcomes:
measure: Pelvic floor symptoms before and after medical weight loss
timeFrame: At least half a year
Secondary outcomes:
measure: To explore the related factors of symptom improvement in pelvic floor dysfunction
timeFrame: At least half a year
measure: To explore the improvement of quality of life before and after medical weight loss
timeFrame: At least half a year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT04723485: Evaluation Study: Obsessive-compulsive Disorders in Childhood and Young Adulthood
Official title: Evaluation Study: Obsessive-compulsive Disorders in Childhood and Young Adulthood
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obsessive-compulsive Disorder
Lead sponsor: Psychiatric University Hospital, Zurich
Sponsor class: OTHER
First posted: 2021-01-25
Enrollment: 625
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The sample consist of pupils with obsessive-compulsive disorder 4 to 18 years

Brief summary: Obsessive-compulsive disorders are very damaging illnesses that can already manifest in childhood and adolescence. With an average prevalence from 1 - 3%, they are one of the most frequently diagnosed psychiatric illness in these age groups. With the further use of data, the treatment success can be significantly improved; causal variables/predictors can be recognized, understood and taken carefully into account. The anticipated incremental knowledge will ultimately help children and young people with obsessive-compulsive disorders to receive faster and more effective treatment.


Eligibility criteria: Inclusion Criteria:

* Children and young people from 8-18 years of age who fulfill the international classification of diseases tenth edition (ICD-10) , obsessive-compulsive disorder handled in our clinic.
* Good German language speaking skills
* IQ \> 75
* All study participants or their legal representative have given written permission for their experiences to be documented in the study.

Exclusion Criteria:

* Schizophrenia-related disorders (psychoses)
* Missing data
* Data sets without confirmed diagnosis
* Purely consultaive patient interview (no therapy intervention prescribed)

Primary outcomes:
measure: Symptoms severity of obsessive and compulsive symptoms in children and adolescents
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Psychiatric University Clinics, Department of Child and Adolescent Psychiatry
state: ZH
Study officials:
affiliation: Sponsor-Investigator
name: Susanne Walitza, Prof. Dr. med. Dipl.-Psych.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02838485: Cortical Activation in Individuals With Finger Amputation During Mirror Versus Imagery Treatment
Official title: Cortical Activation in Individuals With Finger Amputation During Mirror Versus Imagery Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Amputees
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
Collaborators: name: Tel Aviv University
First posted: 2016-07-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Goals : ( a) to examine differences in cortical activity during hand movements with a mirror compared to imagery of the same movements, and (b) to examine correlation between cortical activity during imagery or mirror treatment and the pain and performance measures in finger amputees.

A cross-sectional study of 20 subjects in a Functional Magnetic Resonance Imaging (fMRI) preforming mirror therapy hand movement and imagery hand movement. Also, Visual Analogue Scale for pain and the Disability of the Arm, Shoulder and Hand (DASH) questionnaire and Jebsen Taylor Hand Function Test will be used.

Detailed description: Goals : ( a) to examine differences in cortical activity during hand movements with a mirror compared to imagery of the same movements, and (b) to examine correlation between cortical activity during imagery or mirror treatment and the pain and performance measures in finger amputees.

A cross-sectional one-meeting study of 20 subjects (finger amputees) in a Functional Magnetic Resonance Imaging (fMRI) preforming mirror therapy hand movement and imagery hand movement. Also, Visual Analogue Scale for pain and the Disability of the Arm, Shoulder and Hand (DASH) questionnaire and Jebsen Taylor Hand Function Test will be used.

Eligibility criteria: Inclusion Criteria:

* Following unilateral traumatic finger or fingers amputation (1 to 3 fingers)
* Self-reported limited functionality, sensory disorder or pain

Exclusion Criteria:

* Are not comparable with MRI restrictions
* Chronic pain disease
* Psychiatric condition

Primary outcomes:
measure: Cortical activity
timeFrame: 1 hour
Secondary outcomes:
measure: Visual analogue scale
timeFrame: 10 minutes
measure: Disability of the Arm, Shoulder and Hand
timeFrame: 30 minutes
measure: The Jebsen Taylor Hand Function Test
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
Study officials:
References:
citation: Chan BL, Witt R, Charrow AP, Magee A, Howard R, Pasquina PF, Heilman KM, Tsao JW. Mirror therapy for phantom limb pain. N Engl J Med. 2007 Nov 22;357(21):2206-7. doi: 10.1056/NEJMc071927. No abstract available.
citation: Deconinck FJ, Smorenburg AR, Benham A, Ledebt A, Feltham MG, Savelsbergh GJ. Reflections on mirror therapy: a systematic review of the effect of mirror visual feedback on the brain. Neurorehabil Neural Repair. 2015 May;29(4):349-61. doi: 10.1177/1545968314546134. Epub 2014 Aug 26.
Clinical trial NCT00870285: Ustekinumab Plus UVB-311nm in Psoriasis
Official title: Ustekinumab Plus UVB-311nm Half-side Phototherapy in Patients With Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psoriasis
Keywords: Psoriasis
Biologic
Ustekinumab
UVB-311nm narrowband
phototherapy
half-side comparison
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2009-03-27
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Ustekinumab, an IL-12/23 antibody has been approved in the E.C. and U.S.A. for the treatment of moderate to severe psoriasis. The aim of this study is to determine in a randomized half-side comparison whether additional narrowband UVB-311nm phototherapy accelerates and improves the clearance of skin lesions in Ustekinumab-treated patients.

Detailed description: Patients with moderate to severe psoriasis who receive standard treatment with Ustekinumab (45 mg at week 0, 4, and every 12 weeks) are exposed to UVB-311nm phototherapy on a randomized body half (left or right; head exempt) 3 x per week for six weeks and/or until complete response (defined as reduction in PASI to \< 3). PASI score, patient visual analogue score (VAS) for therapeutic response, and patient VAS for severity of skin lesions is assessed weekly; and at follow-up visits at month 3, 6, and 12. Paired Wilcoxon testing for differences in PASI and patient VAS scores is done; Fischer exact test is applied to determine differences in complete remission, PASI reduction \> 90%, \> 75% and/or 50% between body sites.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Psoriasis patients who receive treatment with Ustekinumab

Exclusion Criteria:

* Age below 18 years
* Pregnancy or lactation
* History of malignant melanoma
* History of invasive squamous cell carcinoma of the skin
* Dysplastic melanocytic nevus syndrome
* Antinuclear antibodies (ds-DNA, Ro/SSA, La/SSB)
* Autoimmune disorders such as Lupus erythematosus or Dermatomyositis
* Photosensitive diseases such as porphyria, chronic actinic dermatitis, Xeroderma pigmentosum, basal cell nevus syndrome, and others
* General poor health status

Primary outcomes:
measure: Modified PASI (psoriasis area and severity index)
timeFrame: 12 months
Secondary outcomes:
measure: Patient visual analogue (VAS) score for therapeutic effect and severity of skin lesions
timeFrame: 12 months
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University, Department of Dermatology
Study officials:
affiliation: Medical University of Graz, Austria
name: Peter Wolf, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05298085: Effect of Intranasal Oxytocin on Dysphagia in Children and Adolescents With Prader-Willi Syndrome
Official title: Effect of Intranasal Oxytocin on Dysphagia Related to Oropharyngo-oesophageal Dysmotility in Children and Adolescents With Prader-Willi Syndrome: a Phase 2B Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Prader-Willi Syndrome
Keywords: Prader-Willi syndrome
Oxytocin
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2022-03-28
Enrollment: 25
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This phase 2B is designed to test the effectiveness of intranasal Oxytocin on Prader Willi Syndrome (PWS).

This is a prospective, multicentre, randomised, double-blind, Phase 2B clinical study planned to include around 24 PWS patients aged 2-17 years and 5 months.


Eligibility criteria: Inclusion Criteria:

1. Male or female patients between 2 years and 17 years and 5 months at inclusion.
2. Genetically confirmed diagnosis of PWS.
3. Parents (or legal representative) have signed the informed consent form and are willing to comply with all study procedures.

Exclusion Criteria:

1. A history of hypersensitivity to the study drug or drugs with similar chemical structures, to excipients of the product, or to latex;
2. Intolerance of intranasal administrations (including when due to a major behavioural problem);
3. Hyponatremia (clinically relevant at the discretion of the investigator);
4. Hypokalaemia (clinically relevant at the discretion of the investigator);
5. Prolongation of the QT interval and/or family history of prolongation of the QT interval;
6. Concomitant treatment prolonging the QT interval;
7. Start of growth hormone (GH) treatment within the last 4 weeks before inclusion;
8. History of abnormal electrocardiogram (ECG) (validated by a cardiologist);
9. Pregnant girls; (for girls with childbearing potential who do not have contraception and are sexually active, a negative pregnancy test will be required)
10. Patient with clinical signs in the context of contact with COVID-19 infected person.
11. Patient included in another study protocol on a medicinal product within the last 6 months;
12. Administrative problems:

    1. Inability to give parents (or legal representatives) expert medical information;
    2. No coverage by a social security regime.

Primary outcomes:
measure: videofluoroscopic swallowing study (VFSS) score change
timeFrame: after 12 weeks oxytocin (OT) / placebo (at V2)
Secondary outcomes:
Other outcomes:
Locations:
city: Lille
country: France
facility: Hopital Jeanne de Flandre
city: Lyon
country: France
facility: Hôpital Femme-Mère-enfant Groupement hospitalier Est
city: Rouen
country: France
facility: Chu Rouen
city: Toulouse
country: France
facility: CHU de Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: TAUBER Maithé, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00995085: Efficacy Study of Metadoxine SR Formulation in Attention Deficit Hyperactivity Disorder (ADHD) Subjects
Official title: Efficacy Study of Metadoxine SR Formulation in ADHD Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: ADHD
ADD
TOVA
METADOXINE
Lead sponsor: Alcobra Ltd.
Sponsor class: INDUSTRY
First posted: 2009-10-14
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This clinical study is designed to evaluate the safety and tolerability of a single oral administration of a Metadoxine slow release formulation to subjects diagnosed as having ADHD. Study also assess cognitive effects of such drug administration.

Detailed description: Primary outcome measure is the safety and tolerability of study drug after a single dosing.

Additional outcomes include commission error rate from the TOVA test. The result is measured as standard score in % compared to the values of the normal population.

Exploratory outcome measures include:

1. TOVA measures like response time , variability, omissions etc.
2. Subtests from Wechsler: digit memory, digit-number signs etc

Eligibility criteria: Inclusion Criteria:

* age 18-45
* diagnosed as ADHD

Exclusion Criteria:

* PDD patients
* head injured patients
* patients suffering from heart, lung, liver, kidney, intestinal, endocrine an neurological diseases and patients who are sensitive to vitamin B

Primary outcomes:
measure: Safety and Tolerability
timeFrame: 24 hours after drug adminstration
Secondary outcomes:
Other outcomes:
Locations:
city: Petach Tikva
country: Israel
facility: ADHD Unit, Geha MHC, Israel
Study officials:
affiliation: Geha MC, Israel
name: Iris Manor, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00272285: A Study of Ramosetron Plus DX, Dexamethasone, Compared to Granisetron Plus DX for the Prevention of Vomiting and Nausea
Official title: A Double-blind, Randomized, Parallel, Comparative Study to Evaluate the Efficacy and Safety of Ramosetron Plus Dexamethasone Injection for the Prevention of Chemotherapy-Induced Vomiting and Nausea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vomiting
Nausea
Keywords: Serotonin antagonists
Randomized controlled trial
Combination drug therapy
Double-blind method
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Astellas Pharma Taiwan, Inc.
First posted: 2006-01-05
Enrollment: 287
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the efficacy and safety of ramosetron plus dexamethasone injection with granisetron plus dexamethasone injection for the prevention of chemotherapy-induced vomiting and nausea.


Eligibility criteria: Inclusion Criteria:

* Subject with age between 20-74 years old (inclusive) of either sex
* Cancer subject is scheduled to receive the designated chemotherapy programs
* Subject without symptoms of vomiting for at least one week before dosing trial medication
* Subject with ECOG performance status scale no greater than 2
* Subject has signed the written informed consent form

Exclusion Criteria:

* Subject has received radiotherapy to the abdomen or pelvis within 4 weeks before entering this study
* Subject has received the designated chemotherapy programs within 6 months before entering the study
* Subject has known heart failure or myocardial infraction or with laboratory abnormalities at screening
* Subject has known concurrent diseases that may cause vomiting
* Subject has taken medications that could influence the outcome of the study within 3 days before entering the study
* Subject with a history of allergy or intolerance to ramosetron, granisetron or dexamethasone
* Female subject who is pregnant or breastfeeding
* Subject with life expectancy less than 3 months
* Subject participated other investigational drug trial within 1 month before entering this study

Primary outcomes:
measure: Proportion of patients without vomiting after the start of chemotherapy for 24 hours
timeFrame: 1 Day
Secondary outcomes:
measure: Response rate of vomiting prevention
timeFrame: 1 Day
measure: The number of vomiting episodes
timeFrame: 1 Day
measure: The nausea degree evaluated by patient's 10-cm visual analogue scale (VAS)
timeFrame: 1 Day
Other outcomes:
Locations:
city: Tainan
country: Taiwan
city: Taipei
country: Taiwan
Study officials:
affiliation: Astellas Pharma Inc
name: Use central contact
role: STUDY_CHAIR
References:
Clinical trial NCT02135185: Effect of the Rehabilitation Effort at Home in Patients With Head and Neck Tumor Treated With Curative Intent
Official title: Phase II Study, Multicentric, Randomized Studying the Effect of the Rehabilitation Effort at Home in Patients With Head and Neck Tumor Treated With Curative Intent
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Head and Neck Cancer
Lead sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
Sponsor class: OTHER
First posted: 2014-05-09
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Improvement exercise tolerance

Detailed description: This study allows improved exercise tolerance in patients undergoing rehabilitation effort

Eligibility criteria: Inclusion Criteria:

* Tumor squamous cell head and neck (excluding nasopharynx) nonmetastatic including cervical lymphadenopathy primitives
* Patient to be treated with curative radiotherapy monofractionnée for at least 6 weeks, with or without concurrent chemotherapy (including targeted therapies)
* KPS ≥ 60

Exclusion Criteria:

* Cancer of the nasopharynx
* Metastatic Patient
* Patients who received neoadjuvant chemotherapy or induction
* Patient parenteral nutrition
* Non-compliant Patient Treatment
* Patient with a cons-indication to the achievement of an effort: clinical signs of pulmonary arterial hypertension (PAH) uncontrolled heart failure, recent myocardial infarction, arrhythmias, unstable angina.
* Patient desaturation in the stress test
* Patient already included in another clinical trial with an experimental molecule
* Pacemaker or defibrillator or neurostimulator
* Contraindications to treatment with standard radiotherapy with or without concurrent chemotherapy

Primary outcomes:
measure: measurement of the increase of initial endurance
timeFrame: up to 24 weeks
Secondary outcomes:
measure: Quality of life
timeFrame: 3 months after the end of radiotherapy
measure: Quality of life
timeFrame: 3 months after the end of radiotherapy
measure: Quality of life
timeFrame: 3 months after the end of radiotherapy
measure: Quality of life
timeFrame: 3 months after the end of radiotherapy
measure: Quality of life
timeFrame: 3 months after the end of radiotherapy
measure: Quality of life
timeFrame: 3 months after the end of radiotherapy
measure: Quality of life
timeFrame: 3 months after the end of radiotherapy
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Institut régional du Cancer - Montpellier - Val d'Aurelle
Study officials:
affiliation: ICM Co. Ltd.
name: Pierre SENESSE
role: PRINCIPAL_INVESTIGATOR
References: