cyrilzakka/clinical-trials huggingface dataset:
Effect of PACK Health Support Program on Patient Reported Outcomes in Patients With Breast Cancer

This trial studies the effect of an electronic health (eHealth) support program called PACK Health on patient reported health outcomes in patients with breast cancer. PACK Health monitors breast cancer patients' reported side effects and experience of care when receiving chemotherapy. Participating in the PACK Health coaching program may improve quality of life, decrease hospital admissions and improve overall health.

PRIMARY OBJECTIVE:

I. To evaluate the effect of an eHealth coaching program on the self-reported global health of women with breast cancer, as measured by the National Institutes of Health (NIH) Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Scale version (v.) 1.2.

SECONDARY OBJECTIVES:

I. To evaluate the effect of an eHealth coaching program on the symptom experience of women with breast cancer as measured by the MD Anderson Symptom Inventory-Breast (MDASI-Br).

II. To evaluate the effect of an eHealth coaching program on physical and mental health of women diagnosed with breast cancer as measured by the subscales of the PROMIS Global Health Scale v 1.2.

III. To evaluate the effect of an eHealth coaching program on the symptom experience and global health outcomes of women by:

IIIa. Disease stage. IIIb. Active treatment type (i.e. surgery, radiation, chemotherapy, hormonal therapy, immunotherapy or a combination of these methodologies).

IIIc. Time since diagnosis. IV. To evaluate the effect of an eHealth coaching program on the frequency of emergency room visits and hospital admissions for patients receiving treatment in the ambulatory setting.

V. To evaluate the relationship between financial toxicity, as measured by the Consumer Score for Financial Toxicity (COST), and quality of life, as measured by the Functional Assessment of Quality of Life-Breast (FACT-B).

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients participate in PACK Health program consisting of weekly contact with an assigned health coach via text message, phone call, and email for 3 months. After 3 months, patients continue to be contacted by the health coach at least once monthly for an additional 3 months.

GROUP II: Patients receive standard of care support services over 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and older
* Able to read, speak and consent in English.
* Individuals with a diagnosis of:

  * First time diagnosis of invasive breast cancer,
  * Ductal carcinoma in situ (DCIS),
  * Recurrent breast cancer off all therapy prior to recurrence
* Currently starting or undergoing active treatment
* Internet access via smart phone, tablet, a computer, or another device with the capacity to receive calls, texts, or e-mails, as well as the electronic study assessments.

Exclusion Criteria:

* Male patients (due to the small number of male breast cancer patients treated annually).
* Individuals for whom there is documentation of inability to provide consent in the medical record.
* Patients who were previously enrolled on protocol 2016-0761.
Youth Mental Health Recovery in the Family After Inpatient Stay

The goal of this longitudinal mixed-methods study is to investigate caregiver strain, family processes and health outcomes after youth psychiatric inpatient treatment. Caregivers of youth who received inpatient treatment for mental health problems will complete a survey at three timepoints (baseline, 3- and 6- month followup) reporting on youth outcomes, caregiver well-being, and family processes. Qualitative interviews on caregivers' challenges, needs, and resources around the return to home care are conducted with a subsample (target n = 10) of participants.

The main research questions (RQs) are:

RQ 1: Do family processes contribute to youth mental health outcomes after discharge from inpatient treatment? RQ 1a: What family-level risk factors predict youth readmission to inpatient treatment? RQ 1b: Do family processes predict youth mental health trajectories over time? RQ 2: Is there a reciprocal relationship between youth mental health problems and caregiver burden? RQ 2a: Do family processes mediate the association between caregiver burden and youth mental health problems? RQ 3: How do caregivers experience their children's return to home care? RQ 3a: What challenges and needs do caregivers report? RQ 3b: What types of follow-up services do families receive and/or have access to? RQ 3c: How do caregivers cope with ongoing difficulties in the post-discharge period?


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* primary caregiver of a child or adolescent aged 7-21 years of any gender who received inpatient treatment in a psychiatric institution in Germany, Austria, or Switzerland (min. 24 h stay) within the past month (regardless of the diagnosis or the reason for the treatment, respectively)
* lived with the child or adolescent in the same household since discharge

Exclusion Criteria:

* another caregiver of the same child has already participated in the study
* insufficient knowledge of German
International Rare Brain Tumor Registry

The objective of the International Rare Brain Tumor Registry (IRBTR) is to better understand rare brain tumors through the collection of biospecimens and matched clinical data of children, adolescents, and young adult patients diagnosed with rare brain tumors.

The International Rare Brain Tumor Registry (IRBTR) is a prospective observational study that will collect tumor samples and matched clinical and radiological data to better understand the outcomes of patients with rare brain tumors in particular: CNS sarcoma, BCOR, MN-1 altered tumors, and other unclassified rare brain tumors.

Data collected include demographics, disease characteristics, treatment information, radiological imaging, and biospecimen collection if available ( tumor tissues Patients will be followed longitudinally to obtain outcome data. Data collection will continue for approximately 10 years.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a known or suspected CNS Sarcoma.
* Patients with a known or suspected BCOR-altered brain tumor
* Patients with a known or suspected Astroblastoma/NM-1 altered brain tumor
* Patients with known or suspected histologically ambiguous/unclassifiable brain tumor
* Patients with a known or suspected rare brain tumor.
* Signed informed consent by patient/ parent or guardian (assent where applicable) to participate in the study.

Exclusion Criteria:

* The patient has an extra-CNS primary tumor.
* The patient is older than 46 years of age at diagnosis.
* The patient or family is not willing to participate or does not sign informed consent.
Role of BP1.3656 on Alcohol Responses

The current study will determine whether a novel pharmacotherapy, BP1. 3656, affects laboratory alcohol self-administration in participants with alcohol use disorder (AUD).

The current study employs BP1.3656, a novel investigational compound with a track record for safety and tolerability in phase I clinical trials. When administered to mice, BP1.3656 was associated with increased metabolism of histamine and elevated brain dopamine and acetylcholine, suggestive of utility in psychiatric disorders including Alcohol Use Disorder (AUD).

This study is a Phase II laboratory-based trial of BP1 .3656 for AUD. 40 non-treatment seeking participants with AUD will be recruited. Participants will be randomly assigned to intervention with BP1 .3656 or placebo in a within-subject, crossover design. During each intervention period, outcome measures relating to alcohol motivation and self-administration will be assessed in the laboratory. It is hypothesized that relative to placebo, alcohol self-administration will be decreased by BP1 .3656.

Eligibility Criteria:
Inclusion Criteria:

* Fulfilling Diagnostic and Statistical Manual (DSM)-5 criteria for AUD with endorsement of 4-8 symptoms
* Average weekly consumption ≥ 14 standard drinks for women and ≥ 21 standard drinks for men over the past 3 months
* Willingness to take study medication and participate in laboratory sessions requiring alcohol administration
* Able to give written informed consent
* Certified as healthy by a comprehensive clinical assessment. Alanine transaminase (ALT) and aspartate aminotransferase (AST) levels should not be more than 1.2 times normal

Exclusion Criteria:

* Seeking treatment for alcohol use (or current efforts to cut down or seek treatment)
* A Clinical Institute Withdrawal Assessment (CIWA) score of 8+ upon initial assessment
* Current medical conditions or medications that contraindicate receiving the study drug (based on the study physician's assessment)
* Meeting criteria for a current substance use disorder aside from alcohol or nicotine
* Recent recreational drug use (assessed via urine toxicology screen)
* History of gross psychiatric or neurological impairment (e.g., schizophrenia, bipolar disorder, neurological disorders)
* Reported difficulty with intravenous procedures
* Self-report of significant alcohol-induced flushing after 1-2 drinks (a proxy for aldehyde dehydrogenase deficiency)
* Currently nursing or pregnant (females)
* Serious unstable medical condition
* Current use of medication that could increase the risk of BP1.3656B administration
* Having any clinical condition, drug sensitivity, or prior therapy which, in the investigator's opinion, makes the participant unsuitable for the study
* Any history of seizures
Weight Bath Traction in Chronic Low Back Pain

It is typical of chronic low back pain that, after the first painful episode, is repeated at 44-78% of patients. For acute lumbar pain, approx. 10-15% of them are converted into chronic. Conservative treatments are few studies done in the traction therapy. A large number of multicenter trials did not evaluate the effectiveness of underwater traction therapy.

Goals are the followings:

1. Is the beneficial effect of a weight bath comparable to a non-treated control group with respect to clinical parameters?
2. How much does the quality of life change in an initial state and how much is it in comparison with the control group?

Eligibility Criteria:
Inclusion Criteria:

* at least 12 weeks of non-specific lymphatic pain,
* the pain sensitivity of the paravertebral muscle and the painful movement of the lumbar spine can be observed, which can be characterized by segmental motion, segmental instability or other reasons
* radiographically confirmed spondylosis, discopathy, and spondylarthrosis within one year.
* back pain at least 30mm (100mm visualis analogue scale).
* patients could not received systemic or locally administered steroid therapy, physiotherapy or they get balneotherapy in the last 2 months

  p- atient consent form signed before the start of test

Exclusion Criteria:

* The exclusion criteria included previous lumbar spine surgery,
* progressive neurologic loss,
* pregnancy,
* (umbilical, hiatal, inguinal) hernia,
* malignities,
* infectious diseases,
* inflammatory pathologies,
* severe pulmonary and cardiovascular diseases,
* uncontrolled- hypertension,
* mental disorders,
* incontinence,
* Acute lower back pain;
* Organic neurological symptoms associated with the lower back;
* pain in the background of osteoporosis or other causes of vertebral compression is likely
* Lack of complience,
* Pain due to inflammatory spinal disease;
* spondylolisthesis (which is not greater than 25% of vertebral skeleton compared to adjacent vertebrae)
The Percutaneous Transmural Arterial Bypass -1 Study (Post Approval Registry)

The purpose of this post-market surveillance study will be to evaluate the real-world use of the DETOUR System in treated patients with symptomatic femoropopliteal lesions from 200 mm to 460 mm in length with chronic total occlusions (100 mm to 425 mm) or diffuse stenosis \> 70% who may be considered suboptimal candidates for surgical or alternative endovascular treatments.

A maximum of 450 subjects will be enrolled with a target study population of at least 200 evaluable female and 200 evaluable male participants at the 12-month post-procedure follow-up visit. A maximum of 200 US sites. Sites will be selected that participate or will participate in the VQI PVI Registry. Follow up visits/assessments will be completed at 1, 12, 24-, 36-, 48-, and 60-months post-procedure. Study enrollment is expected to conclude over 4 years. Follow up data at 1 year is expected to conclude in 5 years from enrollment, with 5-year follow up expected to conclude in 9 years from enrollment.

Eligibility Criteria:
Inclusion Criteria: Participants should be a candidate for the DETOUR System as assessed by the treating physician after review of the clinical and anatomic Indications for Use.

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Exclusion Criteria: There are no exclusion criteria. All cases entered in the registry at participating institutions will be included up through the targeted goals per the enrollment plan.

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Opioid Free Anesthesia and Continuous Post-operative Pulse Oximetry Monitoring in the Obese Patient

Anaesthesia has three major components, analgesia, muscle relaxation and hypnosis.

For a long time, opioids have been covering the analgesia function. (1) When using opioids, an analgesic effect is obtained per-operatively, however, not without side-effects. Post-operative complications such as: respiratory depression, post-operative nausea and vomiting, pruritus, acute opioid tolerance and hyperalgesia, difficulty voiding and ileus, are well known.

Opioid usage is an important risk factor of postoperative desaturation. Postoperative desaturation can lead to severe hypoxemia and even tissue hypoxia, followed by obvious cardiologic and neurological complications.

Thus, in patients at risk, such as the obese patient, experts suggest reducing opioid usage.

Non-opiate protocols implemented on the obese patient have been published. Non-opiate protocols have been established using a combination of ketamine, lidocaine and an alpha-2 agonist.

The main purpose of this pilot study is to evaluate whether patients undergoing an opioid free anaesthesia regime experience less desaturation episodes during the first 24 h post-bariatric surgery than patients having received an opioid anaesthesia regime.

Anaesthesia has three major components, analgesia, muscle relaxation and hypnosis.

For a long time, opioids have been covering the analgesia function. When using opioids, an analgesic effect is obtained per-operatively, however, not without side-effects. Post-operative complications such as: respiratory depression, post-operative nausea and vomiting, pruritus, acute opioid tolerance and hyperalgesia, difficulty voiding and ileus, are well known. These complications may lead to a prolonged hospital stay.

Opioid usage is an important risk factor of postoperative desaturation. Postoperative desaturation can lead to severe hypoxemia and even tissue hypoxia, followed by obvious cardiologic and neurological complications.

Thus, in patients at risk, such as the obese patient, experts suggest reducing opioid usage.

Authors have indeed published non-opiate protocols implemented on the obese patient.

Non-opiate protocols have been established using a combination of ketamine, lidocaine and an alpha-2 agonist.

The main purpose of this pilot study is to evaluate whether patients undergoing an opioid free anaesthesia regime experience less desaturation episodes during the first 24 h post-bariatric surgery than patients having received an opioid anaesthesia regime.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing a gastric by-pass surgery will be screened.
* Patients with an ASA physical status of I-II-III (BMI \>30) will be included.
* Knowledge of either French, English or Dutch will be required in order to be enrolled in this study.

Exclusion Criteria:

* allergy or contraindications to one of the study drugs
* renal failure
* hepatic failure
* hyperthyroidism
* AV block 2 or 3
* severe bradycardia
* left ventricular failure
* unstable blood pressure
* severe respiratory disease
* epilepsy
* psychiatric disturbance.
Mindfulness-based Program for Children With Disruptive Behavior Disorder

The present RCT study investigates whether combined mindfulness program for children and their parents was beneficial for Italian children, aged 8-12, with disruptive behavior diagnosis (DBD). The study tests the program effects on children's behavioral difficulties in school and home contexts; children's and parents' mindfulness abilities; children's impulsiveness; and parents' stress. The study include a sample of 50 children randomly allocate to the intervention or to the control condition (wait-list control sample). Repeated measures of children's and parents' and teachers' reported measures will be used.


Eligibility Criteria:
Inclusion Criteria:

* Disruptive Behavior primary diagnosis

Exclusion Criteria:

* IQ \< 80
* ASD diagnosis
* ongoing other interventions
Bulgarian Squat in the Improvement of Asymmetries of Lower Limbs in Soccer Players

1541/5000 The aim of the Bulgarian squat is to improve the hamstring strength and the stability of the knees, thus reducing asymmetries in the lower limbs. It consists in achieving greater strength and stability of the lower limbs to adapt the athlete to the demands of training and competitions as safely as possible.

The main objective of the study is to assess the effectiveness of the Bulgarian squat, in the improvement of asymmetries in lower limbs; improving hamstring strength and knee stability.

Randomized, simple blind clinical study. 30 soccer players will be randomized to the study groups: experimental (Bulgarian squats) and control (non-intervention team routine). The treatment will last 4 weeks, with 2 weekly sessions of 10 minutes each. The study variables will be: lower limb strength (vertical jump with the My Jump 2 application), lower limb stability (Y ™ -Balance test) and lower limb asymmetries (Triple Hop Test, Single Hop Test for Distance and Functional Movement Screen) The normality of the sample will be calculated using the Kolmogorov -Smirnof test. The changes after each evaluation will be analyzed with the t-student test and with an ANOVA of repeated measures, the intra and intersubject effect will be observed. The effect size will be calculated using Cohen's formula.

An improvement in the strength, stability and asymmetries of the lower limbs in soccer players is expected.


Eligibility Criteria:
Inclusion Criteria:

* Female players
* With an age range of 18 to 35 years
* Federated in the Community of Madrid
* That at the time of the study do not suffer any injury

Exclusion Criteria:

* Athletes who have not undergone surgery on the lower limbs in the last three months
* Who have not taken muscle relaxants in the last three days
* Who have not understood or have a lack of understanding about the intervention
* Have not signed the informed consent document
Frequency of Oral Hygiene

The purpose of this study is to evaluate the frequency of oral hygiene in the maintenance of gingival health in patients with an adequate method of oral hygiene.

The study was a randomized blinded clinical trial. Eligible patients underwent a pre-clinical period in order to eliminate factors that could interfere with the proper plaque control. Forty-five non dental students with healthy gingival (maximum 5% of sites showing gingival bleeding) were randomized into four groups according to the frequency of oral hygiene (every 12h, 24h, 48h or 72h). Plaque Index (PLI) and Gingival Index (GI) were evaluated by two trained examiners at baseline, 15 days and 30 days.

Eligibility Criteria:
Inclusion Criteria:

* students of graduate courses at the Federal University of Santa Maria and Franciscan University Center
* a minimum age of 18 years
* filling all space interdental papilla
* at least 24 teeth
* maximum 15% of sites with gingivitis.

Exclusion Criteria:

* dental students
* pregnant woman
* diabetics
* smokers
* orthodontic equipment
* antimicrobial prophylaxis
* antibiotic
* anti-inflammatory
* psychomotor disturbances
* periodontitis
* PD ≥ 3mm
Long-Term Extension Study of Intepirdine (RVT-101) in Subjects With Dementia With Lewy Bodies: HEADWAY-DLB Extension

This 6-month extension study will provide further information regarding the long-term safety and tolerability of intepirdine (RVT-101) in subjects with Dementia with Lewy bodies (DLB) who have participated in the double-blind, placebo-controlled, lead-in study RVT-101-2001.

This 6-month, double-blind,extension study will provide further information regarding the long-term safety and tolerability of intepirdine (RVT-101) in subjects with DLB who have participated in the double-blind, placebo-controlled, lead-in study RVT-101-2001. The study duration for subjects in study centers in the USA will be 12 months.

Subjects who were randomized to the RVT-101 35-mg and RVT-101 70-mg treatment groups in lead-in study RVT-101-2001 will remain in the same treatment groups for this study; subjects who were randomized to the placebo treatment group in the lead-in study will be assigned to the RVT-101 70-mg treatment group in this study.

Various background therapies, including acetylcholinesterase inhibitors and memantine, will be allowed.

Eligibility Criteria:
Inclusion Criteria:

* Participated in the lead-in study RVT-101-2001.

Exclusion Criteria:

* Any clinically relevant concomitant disease, which, in the opinion of the Investigator, makes the subject unsuitable for inclusion in the study.
ConsultaTM CRT-D Clinical Evaluation Study

The purpose of the Consulta clinical study is to evaluate the overall system safety and clinical performance of the Consulta Implantable Cardioverter Defibrillator with Cardiac Resynchronization Therapy (CRT-D).

The Consulta CRT-D is an investigational bi-ventricular device that provides atrial and ventricular tachyarrhythmia detection and therapy, cardioversion, defibrillation and cardiac resynchronization therapy.

The study will be a prospective, non-randomized, multicenter clinical study, conducted in approximately 18 centers.

To allow for sufficient experience with the device, a maximum of 80 subjects may be implanted with the Consulta device. Data will be collected at baseline (enrollment), implant, 1-, 3-, and 6- months post implant and every 6 months thereafter or until study closure (whichever occurs first), unscheduled follow-up visits, System Modifications, Technical Observations, Study Deviations, Study Exit, upon notification of new or updated Adverse Events and in case of death.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have an indication for a defibrillator.
* Patients who are optimally treated with medication.
* Patients who are New York Heart Association (NYHA) Class III or IV

Exclusion Criteria:

* Patients with a life expectancy less than the duration of the study.
* Patients with medical conditions that preclude the testing required for all patients by the study protocol or that otherwise limit study participation required for all patients.
* Patients with mechanical tricuspid heart valves.
Fascia Iliaca Compartment Blocks for Pain Control in Hip Fractures

This study is comparing the use of a peripheral nerve block and standard opioid pain medications in pain control in hip fractures prior to surgery. A peripheral nerve block is a procedure that injects numbing medicine around a nerve to help decrease the pain, motion, and sensation around the painful site temporarily. The purpose of this study is to evaluate if peripheral nerve blocks are more effective for pain control than just standard opioid pain medication while decreasing the amount of side effects from opioid medication.


Eligibility Criteria:
Inclusion Criteria:

* Aged 50 or older, low energy hip fracture, acute hip fracture

Exclusion Criteria:

* On anticoagulants, hardware present near injection site, preexisting nerve injury.