louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02040844: Phase III Cat-PAD Follow-on Study
Official title: An Optional Prospective Follow-on Study to Evaluate the Continued Efficacy and Safety of Cat-PAD in Cat Allergic Subjects up to Five Years After the Administration of Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cat Allergy
Lead sponsor: Circassia Limited
Sponsor class: INDUSTRY
First posted: 2014-01-20
Enrollment: 430
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the continued effectiveness and safety of Cat-PAD in cat allergic subjects for up to five years after the start of administration of treatment. The study is an optional follow-up study to a phase III double-blind, placebo controlled, Cat-PAD study; no further investigational product is administered.


Eligibility criteria: Inclusion Criteria:

* previously completed clinical study CP007 \[NCT01620762\]

Exclusion Criteria:

* started allergen therapy since completing CP007
* Institutionalised due to a legal or regulatory order

Primary outcomes:
measure: Mean Combined Score (CS) Consisting of TRSS/8+Allergy Medication Score[AMS])
timeFrame: 1 year after completing CP007
Secondary outcomes:
measure: Mean TRSS
timeFrame: 1 year after completion of CP007
measure: Mean Component Scores of the TRSS (Nasal)
timeFrame: 1 year after completion of CP007
measure: Mean Component Scores of the TRSS (Ocular)
timeFrame: 1 year after completion of CP007
measure: Mean Allergy Medication Score (AMS)
timeFrame: 1 year after completion of CP007
measure: Mean RQLQ Score
timeFrame: 1 year after completion of CP007
Other outcomes:
Locations:
Study officials:
affiliation: Clinical Research Center for Dermatology, Allergy & Asthma
name: Jörg Kleine-Tebbe, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03678844: Taekwondo Practice in Adolescents With Attention Deficit Hyperactivity Disorder
Official title: Effect of Taekwondo Practice on Cognitive Function in Adolescents With Attention Deficit Hyperactivity Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Lead sponsor: University of Genova
Sponsor class: OTHER
First posted: 2018-09-20
Enrollment: 40
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Attention Deficit Hyperactivity Disorder (ADHD) is one of the most common neuro-developmental/behavioral disorders among adolescents. Sport and physical activity seem to play a major role in the development of cognition, memory, selective attention and motor reaction time, especially among adolescents with ADHD. In this context, the objective of this study was to investigate the effects of a one and a half year long Taekwondo (TKD) intervention on cognitive function in adolescents with ADHD.


Eligibility criteria: Inclusion Criteria:

* Adolescents with Attention Deficit Hyperactivity Disorder

Exclusion Criteria:

* Participants with good attentional performance

Primary outcomes:
measure: Stroop
timeFrame: 45 seconds
Secondary outcomes:
measure: Ruff 2 and 7
timeFrame: 5 minutes
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01163344: Dance Exercise as Novel Complementary Therapy for Parkinson's Disease
Official title: Dance Exercise as Novel Complementary Therapy for Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinsons Disease
Keywords: Gait, balance, Parkinson's Disease
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2010-07-15
Enrollment: 31
Sex: ALL
Minimum age (years): 40
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: To qualify for this study, subject must have been diagnosed with Parkinson's Disease for 3 years or more, be less than 80 years of age, and have problems with gait and balance

Brief summary: The purpose of this study is to gather data to see if so-called enriched forms of exercise programs such as dance is more effective in improving balance and quality of life in patients with idiopathic Parkinson's disease than regular exercise programs that are currently provided by physical therapists.

Detailed description: Comparison of traditional PT to dance in people who have parkinsons disease to measure which is better for gait, balance and QOL.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of PD at least 3 years ago
* Less than 80 years of age
* Have gait and balance issues

Exclusion Criteria:

* Diagnosis of PD for less than 3 years
* 80 years of age or older
* Not have gait and balance issues

Primary outcomes:
measure: Balance and Gait improvement
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Daniel Tarsy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beth Israel Deaconess Medical Center
name: Veronique Vanderhorst, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06112444: Validity And Reliability Study Of The Turkish Version Of Short Western Ontario Rotator Cuff Index
Official title: Validity And Reliability Study Of The Turkish Version Of Short Western Ontario Rotator Cuff Index
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rotator Cuff Injuries
Keywords: validity of results
reliability of results
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2023-11-01
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: İndividuals diagnosed with Rotator cuff disease by a specialist in Gazi University Faculty of Medicine Orthopedics and Traumatology Polyclinic constitute the sample of the study.

Brief summary: The purpose of this study is to examine the psychometric properties of a Turkish shortened version of the Western Ontario Rotator Cuff Index (SHORTWORC).

Detailed description: Many of the musculoskeletal diseases that doctors treat every day affect both quality of life and functionality. Rotator Cuff diseases are highly prevalent shoulder disorders associated with pain and functional limitations. Thus, surveys measuring treatment outcomes and activity limitations have become important in clinical research. Such scales can be time consuming or impractical for the patient, depending on the areas they evaluate. For this reason, the development of scales focusing on specific areas facilitates evaluations in the clinical environment. The purpose of this study is to examine the psychometric properties the Turkish SHORTWORC index, which is designed to focus on a single parameter.

Eligibility criteria: Inclusion Criteria:

* Between the ages of 18-64
* the presence of rotator cuff pathology requiring surgical treatment

Exclusion Criteria:

* Chronic inflammatory diseases
* cervical spine radiculopathy
* different structural shoulder problems in the last three months
* previous surgery and associated additional pathologies requiring stabilization or other major \*surgery such as superior labral repair
* any history of systemic disease
* being an athlete

Primary outcomes:
measure: Short Western Ontario Rotator Cuff Index
timeFrame: First Day
measure: Constant-Murley score (CMS)
timeFrame: First Day
measure: American Shoulder and Elbow Surgeons Shoulder Score (ASES)
timeFrame: First Day
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University
Study officials:
References:
Clinical trial NCT01982344: A Study Comparing the Impact of Mini-exchange-room and Usual Care on Physical Activity and Quality of Life in Peritoneal Dialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Quality of Life
Keywords: mini-exchange-room
physical activity
quality of life
peritoneal dialysis
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2013-11-13
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To compare the effect of mini-exchange-room and usual care on physical activity and quality of life in peritoneal dialysis (PD) patients through a randomized controlled study. A total of 80 incident CAPD patients with age of 18\~80 years old will be enrolled, who are medically stable and regularly followed up. The one group perform traditional PD procedure (G1), and the other group will utilize disposable mini-exchange-room group (G2). Two groups will be followed for 6 months. Biochemistry data, types of space for bag exchange, physical activity and quality of life will also be collected for all subjects at the 3rd and 6th month. During the study period, peritonitis episode, acute comorbidity and hospitalization will be recorded. The change of physical activity, quality of life and peritonitis rate will be compared between the two groups.


Eligibility criteria: Inclusion Criteria:

* The study will be conducted in the Division of Nephrology, Beijing University First Hospital. A total of 80 incident CAPD patients with age of 18\~80 years old will be enrolled, who are medically stable and regularly followed up. Informed consent is required for each patient.

Exclusion Criteria:

* Those who have (1) intolerance to the study protocols, (2) severe and unstable conditions within one month, acute or chronic inflammation disease, (3) high probability (assessed by the recruiting physician) of receiving a kidney transplant or transferring to HD or drop-out due to socioeconomic causes within 6 months, (4) cognitive or psychological dysfunction, communication barrier, and (5) bag exchange by unfixed manipulator, are excluded.

Primary outcomes:
measure: the improvement in physical activity
timeFrame: 6 months
measure: the improvement in quality of life
timeFrame: 6 months
Secondary outcomes:
measure: times of bag exchanges outside patients' home
timeFrame: 6 months
measure: peritonitis rate
timeFrame: 6 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Jie Dong
state: Beijing
Study officials:
References:
Clinical trial NCT05929144: Optimization of MRI Sequences Used in the Study of Neurodegenerative Diseases
Official title: Optimization of MRI Sequences Used in the Study of Neurodegenerative Diseases at Inserm U1237 NeuroPresage Team, Cyceron Center in Caen
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Memory Disorders
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The Inserm NeuroPresage team has been using MRI for more than 20 years in the study of normal ageing and memory pathologies to further the understanding and the characterization of early diagnosis and the cerebral substrates of cognitive deficits in patients, particularly in the context of neurodegenerative diseases.

Two years ago, a new 3T MRI camera was installed at the Cyceron centre. It is more efficient and should make it possible to obtain better quality images and/or to reduce the time required to acquire these images.

In this context, it seems important to test the different sequences that we classically use in our studies, or that we plan to implement in our next studies (learning and text retrieval fMRI task), in order to optimize them, with a view to integrating them in our future studies.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers of legal age
* Affiliation with a social security scheme or beneficiary of such a scheme
* Signing of the protocol informed consent
* For women of childbearing age or capacity, a urine pregnancy test before inclusion

Exclusion Criteria:

* Protected persons in accordance with articles L. 1121-5 to L.1121-8 of the Public Health Code: protected adults, pregnant and nursing women
* Presence of contraindications to MRI examination without contrast agents injection
* Presence of a chronic neurological or psychiatric condition (including substance use disorder)
* History of brain disease (vascular, degenerative, malformative, tumour, or head trauma with loss of consciousness for more than one hour)
* Current or recent use of medications that may interfere with imaging (psychotropic drugs, antihistamines with anticholinergic action, antiparkinsonian drugs, benzodiazepines including muscle relaxants, long-term steroidal anti-inflammatory drugs, antiepileptic drugs, central painkillers)

Primary outcomes:
measure: Optimization of MRI sequences
timeFrame: During MRI sessions
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: GIP Cyceron
Study officials:
affiliation: Institut National de la Santé Et de la Recherche Médicale, France
name: Gaël Chételat, PhD
role: STUDY_DIRECTOR
affiliation: CHU Caen Normandie
name: Nicolas Cabé, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04677244: Echo-endoscopy Biopsy Impact on the Circulating Tumor Cell Level
Official title: Impact of Echo-endoscopy Biopsy on the Circulating Tumor Cell Level in the Portal System in Pancreatic Adenocarcinoma Management Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer of Pancreas
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
First posted: 2020-12-21
Enrollment: 42
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: prospective monocentric study
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this work is to evaluate the impact of endoscopic procedures on the circulating tumoral cells level in order to evaluate the potential effects of an endoscopic procedure in the management of pancreatic tumors.

Detailed description: The study will include 42 evaluable patients suspected of having pancreatic cancer and for whom an echo-endoscopic biopsy (EUS-FNA) and/or biliary drainage is planned.

In these patients, a 6 ml blood sample will be taken from the portal vein before and after the echo-endoscopic biopsy of the pancreatic mass to determine:

* the level of circulating tumor cells (CTC) per milliliter of blood,
* cytological characteristics of CTCs (isolated, clustered, giant, and clustered including other cell types).

A peripheral blood sample will also be taken to evaluate peripheral CTC levels and cytological characteristics before and after biopsy, as well as one month after biopsy.

Patients will be evaluated every 6 months as part of their follow-up to assess the progression of their pathology and morbidity.

Eligibility criteria: Inclusion Criteria:

* Men and women aged 40-85 years old;
* BMI\< 30 kg/m2;
* Patients suspected of having pancreatic cancer for whom an ultrasound endoscopic biopsy and/or biliary drainage is planned;
* Affiliation to, or beneficiary of, a social security scheme.

Exclusion Criteria:

* Woman who is pregnant or likely to become pregnant (without effective contraception) or breastfeeding ;
* Person in an emergency situation, person of full age subject to a legal protection measure, or unable to express consent;
* Biliary drainage or attempt at prior biliary drainage outside the center ;
* Preliminary oncological treatment for pancreatic pathology covered by the study;
* Clinical and/or image-visible (CT/MRI) carcinosis ;
* Ascites visible on imaging (CT/MRI) ;
* Impossibility to undergo the medical follow-up of the trial for geographical, social or psychological reasons;
* Contraindications to an endoscopic procedure.

Primary outcomes:
measure: Procedure impact
timeFrame: 5 minutes after procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Institut Paoli Calmettes
Study officials:
affiliation: Paoli Calmettes Institute
name: Fabrice CAILLOL, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00210444: Efficacy Study of Dysport® in the Treatment of Anal Fissure.
Official title: A Phase II, Multicentre, Open, Randomised, Parallel Group, Dose Ranging Study to Define the Efficacy of Dysport® in the Treatment of Anal Fissure.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anal Fissure
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 168
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: TREATMENT

Brief summary: To evaluate the effect on healing rates of two different prognostic factors in patients treated with Dysport® for anal fissure: duration of fissure and dose of study drug


Eligibility criteria: Inclusion Criteria:

* Patients having idiopathic anal fissure in the posterior anal midline
* Patients having anal fissure present for less than 6 months
* Patients having symptoms (pain) present for a minimum of 2 weeks and not responding after 2 weeks of standard therapy (diet, laxatives, sitz-bathes)

Exclusion Criteria:

* Patients having anal fistulas or anal fissure of various causes such as Crohn disease, Behcet infectious ulceration, anal suppuration, subfissural infiltration, abscesses, acute haemorrhoidal attacks or inflammatory bowel disease
* Patients having idiopathic anal fissure in the anterior anal midline
* Patients having lateral or multiple fissures
* Patients having anal or perianal cancer
* Patients who underwent previous anal surgery or have cicatricial alterations or post-surgical cicatricial lesions
* Patients receiving drugs affecting neuromuscular transmission
* Patients who have received topical anaesthetic within 3 days of injection
* Patients receiving local treatment by myorelaxing agent
* Patients receiving prohibited analgesics
* Patients having bleeding disturbances or currently using coumarin derivates
* Patients having myasthenia or any genetic muscle disease

Primary outcomes:
measure: Healing of the anal fissure by complete re-epithelisation of the anal canal mucosa.
Secondary outcomes:
measure: Improvement of anal pain measured by the patients on Analogue Visual Pain Scale.
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: Faculty Nemocnice-III
city: Hradec Kralove
country: Czechia
facility: Faculty Nemocnice
city: Prague
country: Czechia
facility: Thomayer's Memorial Hospital
city: Gdansk
country: Poland
facility: Consulting Room of Proctology
city: Lodz
country: Poland
facility: Medical University of Lodz
city: Bucharest
country: Romania
facility: Institute Clinique Fundeni
city: Tunis
country: Tunisia
facility: CHU Hopital Charles Nicolle de Tunis
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03976544: Natural Cycle Versus Hormone Replacement Therapy Cycle for a Frozen-thawed Embryo Transfer in PGT Patients
Official title: Natural Cycle Versus Hormone Replacement Therapy Cycle for a Frozen-thawed Embryo Transfer in PGT Patients: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Miscarriage
Frozen Embryo Transfer
Natural Cycle
Hormone Replacement Therapy Cycle
Preimplantation Genetic Screening
Euploid Embryos
Keywords: frozen-thawed embryo transfer
FET
natural cycle
hormone replacement therapy cycle
miscarriage
Lead sponsor: CRG UZ Brussel
Sponsor class: OTHER
First posted: 2019-06-06
Enrollment: 362
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized to either natural cycle frozen-thawed embryo transfer (group A), or hormonal replacement therapy cycle frozen-thawed embryo transfer (group B).
Primary purpose: TREATMENT

Brief summary: The aim of the current study is to compare miscarriage rates (before 8 weeks) between a true natural cycle (awaiting spontaneous LH surge) and a hormone replacement therapy cycle prior to blastocyst transfer in preimplantation genetic testing (PGT) patients, with biopsy on day 5 of embryonic development. The advantage of performing the study in PGT patients is the exclusion of aneuploidy as a cause of miscarriage.


Eligibility criteria: Inclusion Criteria:

* BMI under 35 kg/m2
* Regular menstrual cycle pattern (i.e. 24-35 days cycle)
* First, second and third ICSI-PGT cycle
* First frozen embryo transfer cycle following a fresh ICSI-PGT attempt
* PGT with trophectoderm biopsy on day 5 of embryonic development
* Signed informed consent

Exclusion Criteria:

* Oligo-amenorrhea
* BMI above 35
* Contraindications for the use of hormonal replacement therapy

Primary outcomes:
measure: Miscarriage rate before 8 weeks of gestation
timeFrame: 8 weeks
Secondary outcomes:
measure: Miscarriage rate after 8 weeks of gestation
timeFrame: 22 weeks
measure: Clinical pregnancy rate
timeFrame: 7 weeks
measure: Ongoing pregnancy rate
timeFrame: 20 weeks
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Centre for Reproductive Medicine UZ Brussel
Study officials:
References:
Clinical trial NCT00034944: Treatment of Patients With Major Depressive Disorder With MK0869 (0869-063)
Official title: A Double-Blind, Multicenter, Placebo Controlled, Acute and Extension Study of 2 Doses of MK0869 in the Treatment of Patients With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2002-05-03
Enrollment: 495
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: A clinical study to determine the efficacy and safety of MK0869 in the treatment of depression.

Detailed description: The duration of treatment is 8 weeks.

Eligibility criteria: Major depressive disorder

Primary outcomes:
measure: HAMD-17 total score at week 8. Tolerability.
Secondary outcomes:
measure: CGI-I Scale score at week 8 and at least a 50% reduction in the HAMD-17 total score.
Other outcomes:
Locations:
Study officials:
References:
citation: Keller M, Montgomery S, Ball W, Morrison M, Snavely D, Liu G, Hargreaves R, Hietala J, Lines C, Beebe K, Reines S. Lack of efficacy of the substance p (neurokinin1 receptor) antagonist aprepitant in the treatment of major depressive disorder. Biol Psychiatry. 2006 Feb 1;59(3):216-23. doi: 10.1016/j.biopsych.2005.07.013. Epub 2005 Oct 24.