louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02425319: CapFlex-PIP© Motion
Official title: Motion Analysis of the Proximal Interphalangeal Joint in Healthy Hands, as Well as in Osteoarthritis Hands Following Implantation With the New CapFlex-PIP© Implant Compared With Silicone Implants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Finger Joint
Arthroplasty
Replacement
Motion
Lead sponsor: Schulthess Klinik
Sponsor class: OTHER
First posted: 2015-04-23
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with proximal interphalangeal joint osteoarthritis in the index or middle finger, treated with a CapFlex-PIP© implant or with a silicone implant and with a follow-up time between 12 and 60 months after primary implantation or patient with one untreated healthy hand without joint osteoarthritis

Brief summary: The purpose of this study is to describe and to compare the motion analysis parameters, i.e. motion and stability of proximal interphalangeal joints, which were treated with a CapFlex-PIP© implant or silicone implant and to generate basic knowledge about motion analysis of untreated healthy hands.


Eligibility criteria: Inclusion Criteria:

* Patients with proximal interphalangeal joint osteoarthritis in the index or middle finger, treated with a CapFlex-PIP© implant or with a silicone implant and with a follow-up time between 12 and 60 months after primary implantation or
* Patient with one untreated healthy hand without joint osteoarthritis
* Patient aged 50 years and over
* Patient willing and able to give written informed consent to participate in the study

Exclusion Criteria:

* Inflammatory disease (e.g. rheumatoid arthritis)
* Pregnant women
* German language barrier to complete the questionnaires
* Any disease process that would preclude accurate evaluation (e.g. neuromuscular, psychiatric or metabolic disorder)
* Legal incompetence
* Participation in any other medical device or medicinal product study within the previous months that could influence the results of the present study

Primary outcomes:
measure: Active PIP joint range of motion (flexion and extension lag) during motion analysis
timeFrame: 1-5 years postoperative
measure: Lateral stability in coronal plane (to ulnar and radial side) during motion analysis
timeFrame: 1-5 years postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Schulthess Klinik
Study officials:
References:
Clinical trial NCT00276419: Treatment of Breast Pain Using A Medication (Diclofenac) Applied to the Skin
Official title: Topical Diclofenac for the Treatment of Noncyclic Breast Pain
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Breast Pain
Non-cyclical Mastalgia
Surgical Scar-Related Breast Pain
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2006-01-13
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study was a randomized, double-blinded, crossover trial of topical diclofenac and placebo (10 weeks of each) for the treatment of noncyclic breast pain.

Detailed description: A prospective, randomized, double-blinded crossover trial comparing topical diclofenac and placebo for 10 weeks in the treatment of 30 women with noncyclic mastalgia and surgical scar-related breast pain.

Eligibility criteria: Inclusion criteria

* Noncyclic mastalgia or surgical scar-related pain occurring at least 2 days per week and for which the patient desires treatment
* Duration of pain \> 2 months (noncyclic mastalgia) or \> 4 months (surgical scar-related pain)
* Age \> 18 years
* Satisfactory breast examination and directed ultrasound at site of pain (all ages) within 12 months
* Satisfactory mammogram (all women \> 30 years of age) within 12 months
* Negative pregnancy test (all women who are premenopausal and have not had hysterectomy or tubal ligation)

Exclusion criteria

* Cyclic mastalgia (as defined above)
* Duration of pain \> 2 months (noncyclic mastalgia) or \> 4 months (surgical scar-related pain)
* Abnormal breast examination or imaging (abnormality at the site of pain or for which biopsy or surgical consultation is recommended)
* Known pregnancy, lactation, positive pregnancy test, or anticipated pregnancy within 6 months
* Asthma, that has been aggravated by oral nonsteroidal antiinflammatory agents
* Allergy, to diclofenac or any nonsteroidal antiinflammatory agents
* Rash or open lesions at the site on the breast where the topical agent would be applied
* Incomplete or abnormal healing (surgical scar-related pain)
* History of gastrointestinal ulceration, renal dysfunction (creatinine \> 1.5), hepatic disease (known liver disease or aspartate aminotransferase (AST) twice normal levels), congestive heart failure and uncontrolled hypertension (blood pressure \> 140/90)

Primary outcomes:
measure: Frequency of Breast Pain
timeFrame: 4 weeks, 10 weeks
measure: Severity of Breast Pain
timeFrame: 4 weeks, 10 weeks
Secondary outcomes:
measure: Mean Days of Pain During the 10 Week Treatment Periods
timeFrame: Approximately 12 weeks and at 24 weeks after randomization
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Robin L. Smith, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05827419: Hearing and Balance Disorders in Peripheral Neuropathy
Official title: Hearing and Balance Disorders in Peripheral Neuropathy
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Charcot-Marie-Tooth Disease
Lead sponsor: Nemours Children's Clinic
Sponsor class: OTHER
First posted: 2023-04-25
Enrollment: 1
Sex: ALL
Minimum age (years): 5
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children and young adults between the ages of 5 and 21 years diagnosed with Charcot-Marie-Tooth will be included.

Brief summary: The long term goal of this proposal is to precisely characterize the auditory and vestibular abilities of children with Charcot-Marie-Tooth (CMT) and how these abilities evolve during the progression of the disorder. This information will be used to refine the management methods for hearing loss and vestibular disorders in these patients. Given that the phenotypic severity is variable within the CMT patient population, we predict that not all CMT patients will present with auditory and vestibular dysfunction. We will therefore collect specimens (i.e., buccal swabs and saliva) from study participants so that their DNA can be isolated and used to determine the genetic basis for auditory and vestibular dysfunction in peripheral neuropathies.

Detailed description: Aim #1: Evaluate the prevalence of auditory and vestibular disorders in children diagnosed with Charcot-Marie-Tooth.

We hypothesize that a significant number of children with Charcot-Marie-Tooth (CMT) will develop auditory and vestibular neuropathies, due to the progression of the disorder. We will examine the characteristics of auditory and vestibular abilities of children and how these relate to the type of CMT.

Aim #2: Examine the progression of hearing and vestibular abilities during the course of the disorder.

We hypothesize that the hearing and vestibular abilities of some children with CMT will deteriorate with time. We will repeat the auditory and vestibular testing on a yearly basis to precisely describe the progression of these abilities.

Eligibility criteria: Inclusion Criteria:

* Individuals diagnosed with Charcot-Marie Tooth

Exclusion Criteria:

-

Primary outcomes:
measure: Prevalence of auditory disorders in children diagnosed with Charcot-Marie-Tooth Characteristics.
timeFrame: 2 years
measure: Prevalence of vestibular disorders in children diagnosed with Charcot-Marie-Tooth
timeFrame: 2 years
measure: Progression of hearing loss
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: Nemours
state: Delaware
Study officials:
affiliation: Nemours
name: Thierry Morlet, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00570219: The Effect of Valproate on Benzodiazepine Withdrawal Severity
Official title: The Effect of Valproate Treatment on Withdrawal Severity in Benzodiazepine Dependent Opioid Maintenance Treatment Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Withdrawal Syndrome
Lead sponsor: University of Helsinki
Sponsor class: OTHER
First posted: 2007-12-10
Enrollment: 30
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 aim of this study is to determine whether valproate is effective in the treatment of benzodiazepine withdrawal symptoms in subjects receiving maintenance treatment for opiate dependence.

Detailed description: In Finland, 90% of subjects with opioid dependence are dependent on benzodiazepines too. Concurrent use of opioids and benzodiazepines has increasingly caused deaths.

Benzodiazepine withdrawal treatment usually comprises gradual drug discontinuation. In one study, valproate was shown to improve benzodiazepine discontinuation success in chronic benzodiazepine users. In the present study, the effectiveness of gradual benzodiazepine discontinuation combined with valproate treatment and carried out in an inpatient setting is compared with gradual discontinuation without pharmacological augmentation.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of benzodiazepine dependence (DSM IV-R)
* Induction of buprenorphine or methadon maintenance treatment, or need of benzodiazepine withdrawal treatment during ongoing buprenorphine/methadon maintenance

Exclusion Criteria:

* Pregnancy
* History of convulsions
* Unstable somatic diseases

Primary outcomes:
measure: benzodiazepine withdrawal severity
timeFrame: 3 weeks
Secondary outcomes:
measure: benzodiazepine use
timeFrame: 4 weeks after treatment
measure: attrition from treatment
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital, Department of Psychiatry, Psychiatric Unit for Drug Dependence
state: Uusimaa
Study officials:
affiliation: Deputy chief physician, Helsinki University Central Hospital, Department of Psychiatry
name: Helena Vorma, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Chief medical officer, Helsinki University Central Hospital, Department of Psychiatry
name: Katila Heikki, Md, Ph.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT06398119: Effect of Visuomotor Training Using Pablo System on Hand Function in Children With Hemiplegic Cerebral Palsy
Official title: Effect of Visuomotor Training Using Pablo System on Hand Function in Children With Hemiplegic Cerebral Palsy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Lead sponsor: Umm Al-Qura University
Sponsor class: OTHER
Collaborators: name: University of Hail
First posted: 2024-05-03
Enrollment: 40
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to investigate the efficacy of Virtual reality on hand function in Saudi children with hemiplegic cerebral palsy.

Detailed description: The aim of this study was to evaluate the effect of Virtual reality on hand function in children with hemiplegic CP. Forty children with hemiplegic CP were assigned randomly into two groups (A \& B). Control group (A) was received conventional rehabilitation program for the hand. Study group (B) was received conventional rehabilitation program as in group (A) in addition to virtual reality by using the Pablo system.Patients' evaluation was carried out before and after training to assess hand function.

.

Eligibility criteria: Inclusion Criteria:

* They had a diagnosis of spastic hemiplegia derived from medical records.
* Scored I-III on the Manual Ability Classification System.
* Not have musculoskeletal disorders that would make it difficult for them to use the VR.
* They had normal or corrected hearing and vision.
* They had no prior experience with the VR.
* They comprehend and follow straightforward instructions to complete the tasks.

Exclusion Criteria:

* They have had upper limb surgery within the last six months.
* They have uncontrollably occurred seizures.
* They have medical conditions that can make using virtual reality dangerous.
* They have attention deficit issues.

Primary outcomes:
measure: Change from baseline spasticity degrees at 3 months
timeFrame: Baseline and 3 months post-intervention
measure: Change from baseline grip and pinch strength at 3 months
timeFrame: Baseline and 3 months post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Ha'il
country: Saudi Arabia
facility: Maternity and Children Hospital
Study officials:
affiliation: Professor
name: Shamekh M Elshamy, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05104619: Spectroscopic Analysis of Tongue Tumor Samples.
Official title: Prospective Analysis of Tumor Tissues From the Oral Cavity by SpiderMassTM Spectroscopy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mass Spectroscopy
Molecular Profile
Surgical Margins
Squamous Cell Carcinoma
Oral Cavity
Tongue
Keywords: mass spectroscopy
molecular profile
surgical margins
squamous cell carcinoma
oral cavity
tongue
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
Collaborators: name: Université de Lille
First posted: 2021-11-03
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated in the Maxillofacial Surgery Department of the CHU Amiens-Picardie for a squamous cell carcinoma of the tongue and for whom the first-line treatment is surgical resection

Brief summary: In squamous cell carcinoma of the tongue, complete surgical resection of the tumor generally represents the primary treatment strategy. Among factors determining the disease prognostic, the surgical margins status is essential for the continued management of the patient, with or without complementary therapies. Generally, surgical margins are defined using visual and tactile elements. Unfortunately, in 15 to 30 percent of cases, they are defined as positive after histopathological examination, on average 5 to 7 days post-surgery.

Techniques have recently been developed to analyze the cancerous and non-cancerous nature of tissues, using the spectral properties of tumor cells. SpiderMass™ is an instrument equipped with a probe for tissue micro-sampling and real-time molecular profile analysis. It is thus ultimately a tool for anatomopathological decision support, for diagnosis and prognosis of the disease. Used in the operating room, SpiderMass™ could also become an innovative surgical tool to precisely define cancerous areas in situ and the margins status in intraoperative conditions.

Based on the principle of artificial intelligence, the SpiderMass™ machine must initially learn to recognize pathological tissues versus healthy. This project aims to accomplish this first phase of machine learning for squamous cell carcinoma of the tongue.


Eligibility criteria: Inclusion Criteria:

* age : 18 years and older
* squamous cell carcinoma of the tongue
* surgical resection as first-line treatment
* tumor classification T1 to T4.

Exclusion Criteria:

* metastatic disease
* neoadjuvant therapies

Primary outcomes:
measure: Tumor cells detection in tongue tumor with SpiderMass technique
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: Centre Hospitalier Universitaire d'Amiens
state: Picardie
Study officials:
References:
Clinical trial NCT06871319: Evaluation of the Difficulty Levels of Restorative Procedures of Endodontic Treated Teeth
Official title: EVALUATION of the DIFFICULTY LEVELS of RESTORATIVE PROCEDURES of ENDODONTIC TREATED TEETH
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Teeth with Root Canal Treatment
Keywords: restorations
root canal treatment
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2025-03-11
Enrollment: 654
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who applied to Erciyes University Faculty of Dentistry, Department of Restorative Dentistry

Brief summary: The goal of this observational study is to evaluate the difficulty levels of restorations of endodontically treated teeth. The main question it aims to answer is:

• Does the 8 predetermined criteria effect the difficulty levels of restorations of endodontically treated teeth.

Participants who has endodontically treated teeth or teeth to be treated endodontically, will undergo clinical and radiological examination. After that clinician will score the teeth between 1-6 based on predetermined criteria.


Eligibility criteria: Inclusion Criteria:

Patients who have at least one tooth with root canal treatment

Exclusion Criteria:

Patients who does not have any teeth with root canal treatment

Primary outcomes:
measure: How hard is it to restore a tooth with root canal treatment based on 8 predetermined criteria.
timeFrame: At the time of enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Erciyes University
state: Melikgazi
Study officials:
References:
Clinical trial NCT06880419: Anti-CD25 rhMAb for aGVHD Prevention in High-Risk Adults Using the daGOAT Model
Official title: A Prospective, Single-arm, Historically Controlled, Single-center Study for Preventing aGVHD, Post-allogeneic HSCT, in Adults at Moderate-to-high Risk Using Recombinant Humanized Anti-CD25 Monoclonal Antibody Based on the daGOAT Model
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Acute Graft-versus-Host Disease
Lead sponsor: Institute of Hematology & Blood Diseases Hospital, China
Sponsor class: OTHER
First posted: 2025-03-17
Enrollment: 174
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: To assess the efficacy and safety of using recombinant humanized anti-CD25 monoclonal antibody injection as a prophylactic strategy for reducing the incidence of severe acute graft-versus-host disease (aGVHD) in adult patients at intermediate to high risk, as predicted by the dynamic aGVHD Onset Anticipation Tianjin (daGOAT) model, following allogeneic hematopoietic stem cell transplantation (allo-HSCT).


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 16 years, regardless of gender.
2. Patients with hematologic disorders who are scheduled to receive allo-HSCT.
3. Voluntarily join this study, sign the informed consent form, have good compliance, and be willing to cooperate with follow-up.

Exclusion Criteria:

1. Patients who have received a second or multiple transplants.
2. Patients who are allergic to, or intolerant of, a recombinant humanized anti-CD25 monoclonal antibody injection.
3. Pregnant or lactating female patients or female patients who are unable to take effective contraceptive measures during the entire trial period.

Primary outcomes:
measure: Incidence of severe aGVHD (Grade III-IV) within 100 days post-transplantation
timeFrame: 100 days after transplantation
Secondary outcomes:
measure: Incidence of aGVHD and aGVHD (any grade) in each target organ within 100 days post-transplantation
timeFrame: 100 days after transplantation
measure: Engraftment rate
timeFrame: 180 days after transplantation
measure: Disease relapse rate
timeFrame: 180 days after transplantation
measure: Infection rate
timeFrame: 180 days after transplantation
measure: Overall survival
timeFrame: 180 days after transplantation
measure: Non-relapse mortality
timeFrame: 180 days after transplantation
measure: GVHD-free relapse-free survival
timeFrame: 180 days after transplantation
measure: Overall Response Rate of severe aGVHD treatment
timeFrame: 100 days after transplantation
measure: Incidence of chronic GVHD
timeFrame: 180 days after transplantation
measure: Adverse events
timeFrame: 180 days after transplantation
measure: Total cost of treatment
timeFrame: 180 days after transplantation
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00639119: Effect of Ropinirole Hydrochloride in Progressive Myoclonic Epilepsy of Unverricht-Lundborg Type
Official title: Effect of Ropinirole Hydrochloride in Progressive Myoclonic Epilepsy of Unverricht-Lundborg Type
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Unverricht-Lundborg Syndrome
Lead sponsor: University of Turku
Sponsor class: OTHER
First posted: 2008-03-19
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The progressive myoclonus epilepsy of the Unverricht-Lundborg disease (ULD) type is an autosomal recessive disease characterized by progressive stimulus-sensitive and action-related myoclonic jerks.

The mainstay of the current treatment in myoclonic epilepsies including ULD are valproic acid and clonazepam among several other antiepileptic drugs. Unfortunately the disease may often be resistant to antiepileptic drugs leading to major reductions in daily activities and disability to walk without assistance. Therefore new treatment modalities are needed. Experimental treatments of ULD patients with dopamine agonists have relieved myoclonic symptoms. Further, in accordance with this, a recent study indicates decreased dopaminergic neurotransmission in the basal ganglia of ULD patients, determined by PET.

The purpose of this study is to investigate the effect of dopaminergic medication (ropinirole hydrochloride, Requip ®) on relieving the symptoms of ULD patients. Patients will undergo sixteen weeks intervention period. The main efficacy determinants are changes in unified myoclonus rating scale (UMRS), nerve conduction, multi-modality evoked potentials including visual evoked potential (VEP), somatosensory evoked potential (SSEP) and brainstem auditory evoked potential (BAEP), blink reflex habituation and electroencephalography (EEG). Tolerability and the safety of the medication are determined. The study setting is placebo controlled, crossover, two-group and double blind study.


Eligibility criteria: Inclusion Criteria:

* Unverricht-Lundborg Syndrome

Exclusion Criteria:

* Pregnancy
* Intolerability to ropinirole hydrochloride
* Mental illness

Primary outcomes:
measure: Unified myoclonus rating scale
timeFrame: 3
Secondary outcomes:
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turku university central hospital, Department of neurology
Study officials:
References: