cyrilzakka/clinical-trials huggingface dataset:
Elbow Heterotopic Ossifications Associated With Radial Head Prosthesis

Elbow heterotopic ossification (EHO) is described as the formation of ectopic bone in tissues not supposed to around elbow. The EHO physiopathology, yet not clarified, has been suggested to be a multifactorial process in which immune system, inflammatory response, CNS and tissue expressed proteins after severe trauma boost hyperactive metabolically bone with no periosteal layer. Consistent with that, EHO has been widely related to elbow trauma, including bone, ligament, muscle or joint; iatrogenic trauma, including epicondylectomy or elbow arthroplasty; neural injuries or burns. Clinical manifestations of EHO has been reported as limited range of motion (ROM), muscle, nerve or joint pain, stiffness and ankylosis all of them leading to upper extremity disfucntion. Prevalence of EHO can range from 3%-45% depending on degree of elbow injury. To our knowledge, prevalence of EHO among radial head fractures had not been assessed previously.

Prevention of EHO has been proposed to be managed with a range of nonsurgical treatment options such as: radiotherapy, NSAIDS and biphosphonate. However, none of them had become clear effective above others, and only surgical excision of EHO had become a reliable option to overcome its associated limitations in elbow motion. Classic approaches suggested delayed surgery until maturity of heterotopic bone, however recent literature suggest early excisions of immature ossification to obtain favorable functional results.

Several studies have investigated risk factors of EHO regarding the high patient burden and health costs to which is associated, however, few published data exists about prevalence and risk factors of EHO after radial head arthroplasty.

Our aim is to assess the prevalence and predictor factors that can lead to EHO after radial arthroplasty in order to be able to predict and apply early preventive treatment to improve postoperative functional outcomes among patients with severe radial head fractures.

Eligibility Criteria:
Inclusion Criteria:

* Adults between 18-85 years-old
* Comminuted radial head fractures treated with radial head arthroplasty

Exclusion Criteria:

* Younger than 18 years; Older than 85 years
* History of previous elbow injuries or operations.
* Pathologic fractures
* Infections
Non Invasive Neuromodulation for Patients With Motor Control Disorders

Movement disorders are neurological syndromes leading to excessive movements or to limited control of voluntary and automatic movements. Many of these disorders are not life-threatening but represent serious difficulties in carrying out the activities of daily living and reduce patient's independence and quality of life.

This project NeuroMOD (neuromodulation for patients with disorders of motor control) proposes the development of a neuromodulation-based platform for the rehabilitation and restoration of motor and cognitive functions of patients suffering from Parkinson's disease (PD). Our project will focus on the application of a novel neurorehabilitation strategy, its functional and clinical validation, and on the evaluation of the impact of the use of the technologies involved in the musculoskeletal and the nervous system as well as user behavior.

Parkinson's disease was selected as target pathology since it represents a paradigm of motor disorder diseases.

Parkinson's disease affects adults and has a very high prevalence and a very high functional impact.

In order to achieve this objective, we have defined the following research areas:

Subproject 1. NeuroMOD: development of a neuromodulation platform composed by a TMS system, and an EMG (electromyography) and EEG (electroencephalography) system in combination with a system of virtual reality based on immersive glasses.

Subproject 2. NeuroMOD-PD: development of therapies and evaluation of clinical evidence and motor and cognitive impact of NeuroMOD in the rehabilitation of patients suffering from Parkinson's disease impact.

Subproject 3. NeuroMOD-Image: development of neuroimaging techniques to investigate the brain areas affected by the proposed therapies and temporary terms that neural plasticity is induced and evolves in Parkinson´s Disease.


Eligibility Criteria:
Inclusion Criteria:

* Idiopathic Parkinsons Disease
* Hoehn Yahr Scale I-III
* No drug changes in the last 90 days
* No exclusion criteria

Exclusion Criteria:

* Dementia (Minimental scale score \<25)
* Dependency (modified Rankin scale \> 3)
* Pregnancy or pregnancy plans
* Pacemaker
* Implanted metal devices
* cochlear implants
* claustrophobia
* drug infusion pumps
* epilepsy / epileptiform anomalies in electroencephalography (EEG)
* known structural alterations in magnetic resonance imaging (MRI)
* Atypical Parkinsonism
* Previous repetitive transcranial magnetic stimulation (rTMS)
* Severe comorbidity (cancer, severe debilitating diseases, etc.)
Predictive Biomarkers in Stage II/III Gastric Cancer for Adjuvant Chemotherapy

Adjuvant chemotherapy followed by curative gastrectomy for Stage II/III gastric cancer has improved disease free time and survival. However, there are still considerable number of patients experience relapse even after adjuvant chemotherapy. In an attempt to select patients who really benefit the postoperative adjuvant chemotherapy, we have identified potential biomarkers (NF-kappaB/JNK) from cell line panel screening followed by immunohistochemical validation. In the present study, we further validate the significance of the biomarkers in a larger set of clinical samples to see if chemotherapeutic response can be determined immediately after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed gastric cancer.
* Operated before November 2009.
* Stage Ib/II(except for T1, T3N0)/III.
* Received postoperative (R0) adjuvant chemotherapy (S-1).
* Not received postoperative (R0) adjuvant chemotherapy (surgery alone).
* Signed informed consent to provide paraffin embedded tissue of removed specimens.

Exclusion Criteria:

* With advanced neoplastic lesions other than gastric cancer.
* Paraffin embedded tissue is not available.
* Unknown S-1 treatment condition.
Health-Related Quality of Life in Patients With Bladder Cancer

RATIONALE: Gathering information about quality of life in patients with cancer may improve the ability to plan treatment and may help patients live more comfortably.

PURPOSE: This clinical trial is studying health-related quality of life in patients with bladder cancer.

OBJECTIVES:

* To identify aspects of survivorship experience that differ by clinical risk (low risk vs high risk) in patients with non-invasive bladder cancer.
* To collect and examine data on health-related quality of life (HRQOL) and symptom management.
* To analyze differences in outcomes between genders, stage and grade of disease, and recency of diagnosis (new diagnosis vs ≥ 6 month diagnosis).

OUTLINE: Patients undergo a 45-minute telephone interview to assess their current medical condition and psychological functioning (i.e., bladder cancer treatment history, levels of depression and anxiety, quality of life, self-efficacy, and perceived social support). Patients complete a series of questionnaires including the Lepore social constraint measure; REACH social support measure; self-report inventories assessing patient communication, relationship style, illness intrusiveness, fear of recurrence, and social constraint; Impact of Events scale; Brief Symptom Index-18 and Global Severity Index; EORTC QLQ-C30 (general health-related quality of life); and EORTC QLC-BLS24 (disease-specific health-related quality of life).

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of non-invasive bladder cancer within the past 4 years

PATIENT CHARACTERISTICS:

* Not pregnant
* Able to read, speak, and understand English

PRIOR CONCURRENT THERAPY:

* Not specified
Study of Biomarkers in Blood and/or Tumor Tissue Samples From Patients With Ductal Carcinoma in Situ and From Healthy Volunteers

RATIONALE: Studying genes in samples of blood and/or tumor tissue from patients with cancer may help doctors identify biomarkers related to cancer.

PURPOSE: This research study is looking at blood and/or tumor tissue samples from patients with ductal carcinoma in situ and blood samples from healthy volunteers.

OBJECTIVES:

Primary

* To collect blood and/or tumor tissue of patients with ductal breast carcinoma in situ (DCIS) and their age- and ethnicity-matched controls to identify the inherited variation that predisposes women to develop DCIS.
* To determine the frequency of these variants.
* To determine the effect of these variants on tumor risk.
* To determine the benefit of testing for these variants in the clinical setting so that those at higher risk could be identified, counseled, and screened.

Secondary

* To analyze the acquired genetic changes within DCIS to identify which cases are more likely to develop invasive disease.

OUTLINE: This is a multicenter study.

All participants complete a questionnaire to collect their family history, a brief medical history, and epidemiological data.

Patients undergo collection of blood and/or tumor tissue samples; DNA is extracted for genotyping, comparison of allele and genotype frequencies (polymorphisms), genetic profiling, DNA analysis, and protein analysis. Histopathology reports are also collected. Healthy volunteers undergo collection of blood samples.

PROJECTED ACCRUAL: A minimum of 3,000 patients and 3,000 controls will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Prior or current diagnosis of pure ductal carcinoma in situ (DCIS)

  * Age ≤ 60 years at the time of diagnosis
  * DCIS with contralateral synchronous or asynchronous invasive breast cancer is permitted
  * DCIS associated with microinvasion (foci \< 1 mm) is permitted
* Healthy age- and ethnicity-matched controls

  * No history of DCIS
  * No relative (up to second degree) diagnosed with DCIS

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Safety Tolerability and Pharmacokinetic of BI 411034

The primary objective of the current study is to investigate the safety, tolerability and pharmacokinetics of BI 411034 in healthy male volunteers following oral administration of single rising doses.

The secondary objective is to explore dose proportionality of BI 411034 in CYP2C19 (Cytochrome P450) genotyped extensive metabolisers (EM).

Another objective is to compare the safety and pharmacokinetic profiles between two different groups of CYP2C19 genotyped subjects, extensive metabolisers (EM) and poor metabolisers (PM)


Eligibility Criteria:
Inclusion criteria:

1. Healthy male subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions
Real World Effectiveness, Persistence, Tolerability, and Safety of Ofatumumab in Clinical Practice

This was a retrospective cohort study using the electronic medical record (EMR) database from Cleveland Clinic. The data was analyzed at start of ofatumumab (OMB) therapy (baseline, defined as 6 months prior to OMB initiation) and at 6 or 12 months following initiation of OMB.


Eligibility Criteria:
Inclusion criteria:

* Patients who initiated OMB commercially from the time of disease modifying therapy (DMT) approval (August 2020), and
* Aged 18 years or older at index date, and
* Patients who met 2017 McDonald Criteria for clinically definite multiple sclerosis (MS), or
* Patients diagnosed with clinically isolated syndrome (CIS) by Cleveland Clinic MS specialist.

Exclusion criteria: Those who were participating in OMB clinical trials (e.g., ARTIOS, OLIKOS)
Intermittent Fasting in Prostate Cancer Patients Receiving Androgen Deprivation Therapy

This is a a pilot study to assess the feasibility of intermittent caloric restriction (plus a plant-enriched diet optionally) in prostate cancer patients receiving androgen deprivation therapy. Study feasibility measures will include enrollment rate, drop-out rate and compliance with diet measured by self-reports.


Eligibility Criteria:
Inclusion Criteria:

* In order to be eligible for participation in this trial, the subject must:
* Be willing and able to provide written informed consent for the trial.
* Be male at birth and least 18 years of age on day of signing informed consent.
* Have measurable prostate cancer disease and be eligible for androgen deprivation therapy.
* Have a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
* Demonstrate adequate organ function (all screening labs should be performed within 10 days of treatment initiation).
* Subjects have archival tumor tissue available or are willing to undergo a baseline biopsy prior to treatment.
* Subjects must have a life expectancy of at least 6 months.

Exclusion Criteria:

* Has an ECOG performance of 2 or higher.
* Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the beginning of the treatment.
* Has a known additional malignancy that is progressing or requires active treatment.
* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
* Has a known allergy, intolerance, or medical contraindication to receiving the contrast dye required for the protocol-specified CT/MRI imaging
* Has any other medical intervention or condition which, in the opinion of the Principal Investigator, could compromise adherence with study requirements or otherwise compromise the study's objectives.
* Is not willing and able to provide written informed consent for the trial.
Using Parental Involvement During Venipuncture to Reduce Venipuncture Pain and Anxiety in Children With Cancer

This study aims to determine whether parental involvement during venipuncture reduces venipuncture pain and anxiety in children with cancer.

This was a randomized controlled trial with parallel groups in which 60 children with cancer aged 6-12 were randomly allocated to a control group (n = 30) and a parent involvement group (n = 30). Each child's anxiety was evaluated by the child using the Children's Fear Scale before, during venipuncture, and each child's pain during the procedure was evaluated by the child using the Wong-Baker Faces Pain Rating Scale. Each child's heart rate and oxygen saturation were measured with a pulse oximeter device before, during the procedure.

Control group (n = 30): Routine venipuncture procedure was applied to the control group. The parent was present in the child's room but did not participate in the procedure.

Parent involvement group (n = 30): A parent was involved in the procedure. The parent held the children in their arms and holding the extremity from which the blood was drawn, holding the hands of children and communicating with their children in the child's room, and in this way the parent was involved in the procedure.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with cancer,
* requiring venipuncture for blood tests,
* 6-12 years old,
* not having taken any analgesics in the 6 hours before venipuncture,
* being in a non-terminal phase of the disease,
* absence of neutropenia,
* volunteering to participate in the study,
* the absence of any health problems that prevent communication in the parent or the child

Exclusion Criteria:

* reporting pain for another reason in the time of the venipuncture
* having another chronic disease besides cancer
Rocking Chair Therapy in Elderly With Dementia: Its Effects on Agitation

Patients with dementia exhibit a wide range of behavioral symptoms which include mood disturbances (e.g depression, anxiety), behavior and activity disturbances (e.g agitation, aggression, wandering) and psychotic symptoms (e.g hallucinations and delusions). Behavioral disturbances are a major source of caregiver burden and an important contributor to the decision to admit AD patients to institutionalized long-term care.

Among the innovative approaches, rocking chair therapy has been introduced as a potential means for reducing agitation in elderly with dementia. Only few studies evaluated the effect of this therapy on the behavioral symptoms in elderly with cognitive impairment. The results were promising, but not sufficiently significant.

We propose to perform this study having as a main goal to evaluate the effect of the rocking chair therapy in agitation for home care residents with dementia. The secondary aim of the study will be the evaluation of psychoactive drugs use as well as pain killers. Cohen Mansfield agitation inventory will be employed for the pre- and post-therapy evaluation.

Included subjects will be installed in groups of five, rocking chairs will be placed away from other residents in a semicircle in a corner of the dayroom. The therapy sessions will be held every afternoon, for two hours, under the supervision of the unit psychologist and a master's degree psychology student. During the daily session, each resident should be encouraged to actively rock to reach the goal of 60 minutes of rocking accumulated per day. The total duration of the therapy period will be 6 weeks. The use of pharmacological restraint (neuroleptics, anxiolytics) and pain killers will be evaluated before, during and after the six weeks therapy.

The expected outcome is a reduction of agitation among elderly with dementia, as well as a reduction in the use of pharmacological restraint and pain killers.


Eligibility Criteria:
Inclusion Criteria:

* resident of the EHPAD / LTC for at least 10 weeks
* subject with cognitive impairment (MMSE \<24) documented according to DSM-5 criteria
* with chronic behavioral disorders such as agitation
* stable from a medical point of view
* without restraint when not in bed
* ability to touch the floor with the toes while sitting in the rocking chair
* ability to sit securely in the rocking chair
* ability to tolerate rocking chair
* Ability to maintain active rocking for at least 5 minutes over a 30-minute period during the three pre-treatment trials
* obligation for all patients to be affiliated to a social security scheme
* signing of the informed consent by the patient and / or his legal representative

Exclusion Criteria:

* Motor deficiency (example: after-effects of stroke ...) not allowing a secure installation in the chair or preventing an active rocking
* ATCC with vestibular involvement that may lead to vertiginous seizures during rocking
* Aging psychiatric pathology
Maternal Well-being in the Postnatal Stage

The objective of this study is to design and validate an online intervention aimed at promoting well-being in women with postpartum depression. For this, the design of a multicomponent protocol consisting of empirically validated positive interventions and comparing these with a group Cognitive Behavioral Therapy (CBT) is proposed, following the National Institute for Health and Care Excellence (NICE) recommendations for the treatment of depression. Participants will be screened for inclusion in the program if they meet clinical criteria. After that, they will be randomly assigned to a CBT group or a positive psychology intervention (PPI) group.

Participants will be randomly assigned to the CBT group or the PPI group. Both groups will be treated identically except for the type of intervention. Group assignment will be blind to both patients and investigators.

Both interventions have 10 weekly sessions. Sessions will be in groups and online.

CBT includes 3 modules: behavioral activation, cognitive restructuring, and interpersonal skills. Main contents (10 sessions): (1) Symptoms of Depression. Myths about motherhood. CBT approach; (2) Stress and Anxiety. Relaxation; (3 and 4) Increase pleasurable activities. Balance in life. To manage time; (5) Management of negative thoughts. Health concerns; (5 and 6) Increase positive thoughts; (7) social skills; (8) Communication skills and parner support; (9) Plan for the future. New routines and strategies; (10) Relapse prevention. CBT has been shown to be effective in reducing depressive symptoms and modifying attentional biases (Pearson et al., 2013).

On the other hand, a new protocol of positive interventions adapted for women after maternity (PPI) will be designed and applied. This multicomponent protocol includes interventions that have already been empirically validated in treating depression. PPI includes 2 modules: hedonic well-being and eudaimonic well-being. Main contents (10 sessions): (1) Symptoms of Depression. Myths about motherhood. PPI approach; (2) Mindfulness and positive emotions; (3) Gratitude and savoring; (4) Emotion regulation (5) Positive relationships and social support; (6) Compassion; (7) Personal strengths; (8) Goals and values; (9) Resilience; (10) Relapse prevention.

Eligibility Criteria:
Inclusion Criteria:

* Women who have been mothers in the last year

Exclusion Criteria:

* Women who have been mothers in the last month,
* Women who meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for substance abuse and/or dependence within 30 days prior to study participation,
* Women who have a serious mental disorder that makes it difficult to follow the protocol (e.g. serious neurocognitive problems or brain damage; schizophrenia and other psychotic disorders).
Compliance Of Medication After Discharge From the Hospital in the Elderly

Many elderly patients have multiple medications and variable dosing regimens and the ability for hospitals to properly reconcile medications between what is given on paper to the patient and what the patients take at home depends on the patient's ability to get the medications. Some patients may delay in getting their medications from the pharmacy after being discharged. For some it may be a lack of transportation, others may feel too ill to travel and may not have family members who will be able to pick up the medications.

It is for these reasons the authors of this study want to inventory the medications that an elderly patient is being discharged on during a home visit and check on the actual prescriptions that a patient has at their house the following 1-2 days after discharge.

The goal is to evaluate the effectiveness of discharge instruction in the elderly by assessing medication compliance post-discharge. Patients are identified on the units and from a Beaumont Troy discharge planning master list. Prior to discharge the patients are consented and informed they will be contacted to schedule a home visit. During the home visit, the medications the patient is currently taking are recorded. Discharge medications are recorded from the medical record following the home visit. The Investigator performing the visit is blinded to the discharge medications as the intent of the visit is only to collect data and not to ensure compliance or make clinical judgment regarding the appropriateness of the medication regimen. Anyone 65 or older can be included, who are discharged with medications and can consent. Those excluded are patients who do not live in close proximity and those discharged to extended or long-term care facilities.

Eligibility Criteria:
Inclusion Criteria:

1. Elderly patients (age 65 or older)
2. Able to make own decisions (Patient has autonomy) and therefore able to make informed decisions
3. Patients with medications upon discharge from the hospital

Exclusion Criteria:

1. Patients that have the inability to give informed consent secondary to: cognitive disabilities, inability to speak or write or refusal to participate in study.
2. Patients that are younger than the age of 65.