cyrilzakka/clinical-trials huggingface dataset:
Retrospective Evaluation of Perampanel in a French Neurology and Epileptology Department (Hospices Civil de Lyon)

Perampanel is a non-competitive antagonist of the AMPA ( 2-amino-3-(5-méthyl-3-hydroxy-1,2-oxazol-4-yl)) propanoïc acid receptors which was approved by the European Medicines Agency as adjunctive treatment for partial-onset seizures in patients 12 years and older, in 2012. The aim of this study is to evaluate effectiveness and safety of perampanel as add-on treatment in patients with refractory epilepsy.

The investigators retrospectively collected and analyzed the data of patients with refractory epilepsy who had been treated with perampanel between May of 2014 and April of 2015. In total, one hundred and ten patients were included (mean age 41 \[SD = 15.2\]). The mean duration of epilepsy was 25 years (SD = 14.4). The mean perampanel dose was 5.7 mg/d (SD = 2.3). The retention rate was 77% at 6 months and 61% at 12 months. After 6 months, the responder rate was 35.5%. Eight patients (7.3%) became seizure free. Adverse effects were reported in 60 patients (54.5%). Most common side effects were behaviour disturbance (22.7%), dizziness (15.5%), asthenia (11.8), somnolence (10%) and ataxia (9.1).


Eligibility Criteria:
Inclusion Criteria:

* Patients with refractory focal epilepsy
* Initiation of perampanel between 05/2014 and 04/2015

Exclusion Criteria:

* Exact date of initiation of Perampanel not defined
* Patients without follow-up data
Analgesia After Total Shoulder Arthroplasty

The purpose of this study is to determine which medication(s) should be included in the interscalene nerve block (an injection of local anesthetic \[numbing medicine\] near nerves in the shoulder) for patients undergoing total shoulder arthroplasty (shoulder replacement). The ideal nerve block would reduce pain after shoulder surgery without causing a great deal of muscle weakness.

All patients will receive an intravenous pain pump (patient-controlled analgesia) and a nerve block with long-lasting local anesthetic. The three study groups will receive additives (clonidine, dexamethasone, buprenorphine plus local anesthetic) in the nerve block that may reduce postoperative pain. One of the study groups uses the usual concentration of local anesthetic, while the other two study groups use reduced concentrations of local anesthetic. Follow-up with study patients begins on the day of surgery and continues through postoperative day 2. Seen twice daily, patients will be asked about their pain and assessed for sensory function and strength of their shoulder muscle and hand grip.

Eligibility Criteria:
Inclusion Criteria:

* Patients with osteoarthritis
* Primary total shoulder arthroplasty
* Age 18 to 80 years old
* Planned use of general anesthesia
* Planned use of a brachial plexus nerve block for postoperative analgesia
* Ability to follow study protocol

Exclusion Criteria:

* Patients younger than 18 years old and older than 80
* Allergy or intolerance to one of the study medications
* Patients with an American Society of Anesthesiologists (ASA) physical status of IV
* Patients with insulin-dependent diabetes
* Patients with hepatic (liver) failure
* Patients with chronic renal (kidney) failure
* Bradycardia (heart rate \< 50) or hypotension (systolic blood pressure \< 90 mmHg)
* Chronic opioid use (taking opioids for longer than 3 months) (or active diagnosis of complex regional pain syndrome \[CRPS\]/reflex sympathetic dystrophy \[RSD\])
* Lack of English fluency
Targeting Burdensomeness Among Clinic Referred Youth

This study will develop and pilot test a novel intervention module targeting perceived burdensomeness toward others in 30 clinic referred youths who experience anxiety or depression and elevated levels of burdensomeness. All participants will be assigned to receive the intervention in this open trial.

Suicidal ideation is prevalent and impairing in youth, with approximately 15% of high school students reporting seriously considering a suicide attempt and making a specific plan for suicide in the past 12 months. Substantial evidence documents perceived burdensomeness towards others, or the belief that one is a burden or drain on others, as a risk factor for suicide ideation in youth. This evidence highlights the potential promise of perceived burdensomeness as a novel intervention target to prevent suicide ideation in youth. The current study will develop and preliminary evaluate a novel, brief behavioral treatment module targeting perceived burdensomeness in youth that can be embedded within existing psychosocial treatments. The study will use an open trial design. The first aim of this proposal is to develop a novel, brief psychosocial intervention module (the GIVE module) targeting perceived burdensomeness towards others that can be embedded within existing CBT protocols for youth internalizing problems. The second aim is to collect data relevant to client satisfaction and reductions in perceived burdensomeness. Participants will be N=30 clinic-referred youth ages 10 to 17 years with anxiety or depressive disorders in a university-based research clinic, who display elevated levels of perceived burdensomeness. In the context on ongoing CBT for anxiety or depression, participants will complete the GIVE module at sessions 6 and 7 of the CBT protocol. It is hypothesized that perceived burdensomeness will be significantly lower after the GIVE module is administered, and that client satisfaction will be high. Data collected in this study will provide the foundation for a subsequent randomized controlled trial of the GIVE module.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of an anxiety disorder, persistent depressive disorder, or major depressive disorder
* Score \> 4 on the youth self-report Interpersonal Needs Questionnaire- Perceived Burdensomeness Scale

Exclusion Criteria:

* Clinical diagnosis of a Psychotic Disorder, Autism Spectrum Disorder or Intellectual Disability
* Show high risk of imminent self-injurious behaviors
* Be involved currently in another behavioral treatment
* Not live with a primary caregiver who is legally able to give consent for the youth's participation
* Be a victim of previously undisclosed abuse requiring investigation or ongoing supervision by the Department of Children and Families.
Smoking Relapse Prevention Via Just-in-Time-Adaptive Interventions

A small-scale randomized controlled trial (RCT) will pilot test a personalized JITAI designed to guide delivery of fast acting nicotine replacement therapy (NRT; lozenge) in real-time, to prevent smoking relapse. Specifically, a smartphone application (app), will integrate pre-quit smoking data with objective location data captured via global positioning system (GPS) to establish relapse risk (hotspot) algorithms. During a quit attempt, the GPS-enabled app (QuitBuddy) will detect proximity to hotspots and deliver NRT prompts, all of which will occur automatically and prior to exposure. Thus, QuitBuddy will optimize NRT use to prevent cue-provoked cravings known to undermine sustained abstinence, thereby repurposing this evidence-based cessation medication to promote relapse prevention. QuitBuddy will be tested against standard care (NRT with brief instructions). Two versions of QuitBuddy will be tested, which will differ only in how hotspot algorithms are derived: retrospectively from locations recalled at the onset of a quit attempt (QuitBuddy-Recall) or based on real-time EMA completed pre-quit (QuitBuddy).


Eligibility Criteria:
Inclusion Criteria:

* at least 18 years of age
* daily cigarette smoker of \> 9 cigarettes/day for past year
* CO breath monitor detects \> 10ppm
* literate in English
* willing to make a quit attempt in the next week with nicotine replacement therapy
* no plans to travel outside of a 100-mile radius of Charleston during the study

Exclusion Criteria:

* FDA contraindications for use of NRT:

  1. Pregnant
  2. Breastfeeding or planning to become pregnant
  3. Recent (past 3 months) cardiovascular trauma: MI, stroke
* current use (past 30 days) of alternative tobacco products or smoking cessation medications
Effect of Extracorporeal Adsorption of Plasma Neutrophil Extracellular Traps (NET) in Sepsis

This open non-randomized controlled single center study investigates to what extent the removal of circulating Neutrophil Extracellular Traps (NETs) from blood by NucleoCapture device has a positive effect on the treatment of patients with sepsis and sepsis-associated AKI (SA-AKI).

The term "sepsis" refers to a clinical syndrome in which a dysregulation of the host's inflammatory reaction to infection leads to a life-threatening of organ dysfunctions. Sepsis and septic shock are major causes of death in intensive care units worldwide. Sepsis remains the most important cause of AKI in the intensive care unit (ICU) with 15%-20% of patients with sepsis-associated AKI (SA-AKI) prescribed RRT . In addition to association with short term mortality, AKI is also linked to the later development of CKD, ESRD, and long-term increased risk of death

NETosis is a unique form of neutrophil cell death that is characterized by the release of neutrophil extracellular traps (NETs) composed of DNA web-like structures decorated with highly cytotoxic protein components. Release of NETs leads to bystander tissue damage (including the kidneys) and drives a fatal course of disease in sepsis patients.

The plasmapheresis is a medical procedure, where pathogenic components are being removed from the blood by adsorbers outside the body in an extracorporeal circulation. For removal of the pathogenic substances the plasma is separated from the blood to pass the adsorber. The purified plasma is merged with the solid blood components thereafter and returned to the patient. The NucleoCapture device provide highly selective removal of neutrophil extracellular traps from human blood during plasmapheresis procedure.

Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥ 18 and ≤ 75 years of age.
* Meet the clinical criteria of sepsis according to the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3))
* Written informed consent

Exclusion Criteria:

* A terminal state
* Active bleeding or uncontrolled acute massive bleeding
Vitamin D and Head and Neck Cancer: Impact on Toxicity and Prognosis

The goal of this observational study is to learn about relation between vitamin D levels in subjects with head and neck cancer. The main question it aims to answer are:

* variation of vitamin D levels in the study population at different time points
* relation between therapy side effects and vitamin D level
* relation between disease outcome and vitamin D level Participants will be followed as per clinical practice

There are only a few works in the literature that correlate the circulating levels of vitamin D with the prognosis or development of toxicity in treated HNSCC patients with radical intent radiation therapy. These small studies have highlighted a worse outcome and greater toxicity in patients with low vitamin D levels. The study aims to study the variations in circulating levels of vitamin D in a multicenter cohort of patients with HSNCC prospectively collected and to evaluate the impact of vitamin D levels at diagnosis on the development of toxicity and on disease outcome

Eligibility Criteria:
Inclusion Criteria:

histologically proven HNSCC (squamous cell carcinomas), all subsites

* non-metastatic locally advanced stages
* patients candidate for radical or adjuvant radiotherapy
* patients candidate for bilateral neck irradiation
* written informed consent

Exclusion Criteria:

* distant metastases
* patients with known disorders of calcium/vitamin D metabolism
Pediatric Subjects With Tinea Corporis

The study is being done to see how well the study cream works when applied once a day to affected area of child (where they have ringworm). The results will be compared to those seen with a placebo cream which has no active ingredient. Safety of the cream will also be measured.

The objectives of this study are to evaluate the safety and efficacy of Naftin (naftifine hydrochloride) Cream, 2% applied once daily for 2 weeks, compared to its vehicle in the treatment of pediatric subjects aged 2 to 17 years and 11 months with positive potassium hydroxide (KOH), positive dermatophyte culture, and clinical signs and symptoms of tinea corporis.

Eligibility Criteria:
Inclusion Criteria:

* Males or non-pregnant females 2 years of age to 17 years, 11 months, of any race. Females of child bearing potential must have a negative urine pregnancy test.
* Presence of tinea corporis by clinical evidence of a tinea infection of at least moderate erythema, moderate induration, and mild pruritus.
* KOH positive and culture positive baseline skin scrapings obtained form the site with the mose severely affected lesion or a representative site of the overall severity.

Exclusion Criteria:

* Tinea infection of the face, scalp, groin, and/or feet
* A life-threatening condition in the opinion of the investigator (ex. autoimmune deficiency syndrome, cancer, etc) within the last 6 months.
* Subjects with abnormal findings- physical or laboratory- that are considered by the investigator to be clinically important and indicative of conditions that might complicate interpretation of study results
* Subjects with a known hypersensitivity or other contradictions to study medications or their components.
* Subjects who have a recent history or who are currently known to abuse alcohol or drugs.
* Uncontrolled diabetes mellitus.
* Hemodialysis or chronic ambulatory peritoneal dialysis therapy.
* Current diagnosis of immunocompromising conditions.
* Current evidence of compromised skin, atopic or contact dermatitis, eczema, impetigo, lichen planus, pityriasis rosea, pityriasis versicolor, psoriasis, seborrhoeic dermatitis and syphilis.
* Severe dermatophytoses, mucocutaneous candidiasis, or bacterial skin infection
* Patients with tinea corporis who have concurrent dermatophytosis of the scalp, beard or nails.
Trauma-Informed Procedural Pain Intervention: Refinement of an Evidence-Based Protocol

The Trauma-Informed Procedural Pain Intervention (TIPPI-R) has been developed as a standardized way to provide education and teach evidence-based strategies for managing pain and distress that may occur during pediatric cancer treatment. The purpose of this clinical trial study is to test how helpful TIPPI-R is in supporting children and families manage pain and distress during the initial stages of cancer treatment. The main questions this study aims to answer are:

* Does TIPPI-R increase use of helpful pain coping strategies for pediatric cancer patients?
* Does TIPPI-R help lower perceived pain intensity during initial stages of cancer treatment?
* Does TIPPI-R increase patient and family confidence in coping with pain and distress during cancer treatment?

Researchers will compare pain experiences and use of pain coping strategies for families who receive the TIPPI-R intervention and families who receive standard of care to see if TIPPI-R decrease pain and distress during the initial stages of cancer treatment.

Participants will:

* Complete surveys to measure pain and distress within 5 weeks of initial diagnosis (Time 1)
* Either receive the TIPPI-R intervention or standard of care
* Complete surveys to measure pain and distress 4 weeks after initial consent or TIPPI-R intervention delivery (Time 2)


Eligibility Criteria:
Inclusion Criteria:

* Patient is receiving treatment at Norton Children's Cancer Institute, Norton Children's Hospital, University of Kentucky Children's Hospital or DanceBlue Clinic.
* Patient has been diagnosed with an oncology diagnosis.
* Patient and family are English-speaking.
* Patient is between the ages 0-18.

Exclusion Criteria:

* Families not proficient in English.
* Patient is 19 years or older.
* Patient is not receiving treatment at Norton Children's Cancer Institute, Norton Children's Hospital, University of Kentucky Children's Hospital or DanceBlue Clinic.
* Patient does not have an oncology diagnosis.
* Patient and family have any CPS involvement.
Yoga Intervention to Improve Pediatric Cancer Patients' Sleep & Life Quality and Parents' Well-Being

The proposed project will examine feasibility and preliminary efficacy of a yoga intervention in the pediatric oncology unit at Connecticut Children's Medical Center (CCMC) and includes two parts: (1) a survey of children and parents regarding preferences (e.g., convenient days/times), experiences and expectations regarding yoga (including barriers and positive expectancies) and (2) an eight week clinical trial of a yoga intervention in 10 pairs of children and parents.

The specific aims and hypotheses for this seed grant are to collect and assess data on:

Aim 1 feasibility - perceived barriers/solutions, interest and accrual rates, attendance per session, participant retention, evidence of institutional support and resource commitment Hypothesis 1: A yoga intervention is feasible among pediatric oncology patients and their parents; (2) preliminary efficacy - including effect sizes for calculating power Hypothesis 2a: A yoga intervention improves pediatric oncology patients' fatigue, QOL, and sleep.

Hypothesis 2b: A yoga intervention improves parental QOL and caregiver burden.

We will be using the following questionnaires and scales to help answer the quesitons related to the hypotheses and aims:

PedsQL 4.0 PedsQL 3.0 Cancer Module The Fatigue Scale SleepDiary Actigraphy data. Child Home Yoga Practice Diary Satisfaction survey

Questionnaires noted below are given only to the parents:

SF-12 Zarit Caregiver Burden Index Yoga Satisfaction Survey

Study participants will have 4 yoga sessions and the questionnaires and surveys are done prior to the first yoga session and after the last yoga session.

The yoga sessions are created with both the study participant and a certified yoga instructor. The patients are given the yoga routine to practice at home at their leisure.

Eligibility Criteria:
Inclusion Criteria:

* Parents and children (ages 8-18) undergoing treatment (chemotherapy and/or radiation therapy) for cancer.
* Cancer diagnosis, between the ages of 8-18 year, English speaking, and medically cleared to participate in yoga.
* Parents will be eligible if they are over 18 years old, English speaking, and physically able to participate in yoga.

Exclusion Criteria:

* Children and parents not meeting inclusion criteria
Comparison of Different Dose of Anti-T Lymphocyte Globulin (ATLG) in Haploidentical HSCT for GVHD Prophylaxis

This study aims to compare the incidence of graft-versus-host disease (GVHD) in haploidentical hematopoietic stem cell transplant recipients who receive varying doses of anti-T lymphocyte globulin (ATLG) for GVHD prophylaxis. Our primary objective is to determine the optimal dose of ATLG for preventing acute GVHD (aGVHD). Additionally, we plan to evaluate the impact of different doses of ATLG on post-transplant viral infections and other clinical outcomes.

Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is the only therapeutic option for many hematological malignancies. Haploidentical related donor transplantation is now considered an important allo-HSCT. GVHD prevention has a crucial role in post-transplant outcomes by potentially interfering with the graft-versus-leukemia (GVL) effect and immune reconstitution. In vivo T cell depletion (TCD) modalities, including anti-T lymphocyte globulin (ATLG)-based protocols have been widely used worldwide for GVHD prophylaxis.

Several European studies have shown that a dose of 30mg/kg of ATLG can effectively prevent GVHD with acceptable safety. But, the most commonly reported dose among Chinese population is 20mg/kg. Additionally, the main type of allo-HSCT in China is haploidentical transplantation. The application experience of ATLG in Europe mainly focuses on sibling and unrelated donor transplants. There is still a lack of sufficient exploration on the optimal dose of ATLG in GVHD prevention in haploidentical transplantation.

In this prospective multiple-center randomized trial, we aim to compare the effects of different doses of ATLG on GVHD prevention, risk of viral infection, and patient survival after haploidentical transplantation.

Eligibility Criteria:
Inclusion Criteria:

* 1，Age ≥ 16 and ≤ 65 years 2, Patients undergoing Haplo-identical hematopoietic stem cell transplantation 3, AML and ALL in complete cytologic response or MDS requiring allogeneic stem cell transplantation 4, ECOG performance status ≤ 2

Exclusion Criteria:

* 1，Pregnant or lactating females 2，Patients who have previously undergone allogeneic hematopoietic stem cell transplantation or organ transplantation 3, Patients with major organ abnormal including renal, liver, lung , heart and/or CNS diseases, where these diseases or others cannot be controlled by treatment and may affect the completion of this study 4, Uncontrolled infection 5, Seropositivity for HIV or HTLV-1 or active hepatitis B or C 6, Patients with any other complications that may affect this study or with a history of malignant diseases.
Model for Heart Failure ExAcerbation Reduction Trial

Heart failure is the leading cause of hospitalizations and readmissions in the United States and is a tremendous economic strain on our healthcare system. There is currently, based on national averages, a 30% readmission rate and 10% mortality rate within 3 months of being hospitalized for heart failure. Retrospective studies have shown benefit to using biomarkers such as BNP to guide inpatient heart failure management. Our own CCF retrospective study showed that decreasing NT-ProBNP by 23%, making patients fluid negative by more than 1.3L, and discharging patients with serum sodium above 135 reduces readmission rates significantly. The purpose of this study is to prospectively use the above mentioned goals in the treatment of heart failure in order to reduce heart failure readmission and mortality rates.

All HF patients admitted to CCF will receive a short consent form. The study will enroll patients for one year. Physicians will initiate / titrate medications and obtain consults as usual but are highly encourage to keep patients in the hospital until at least 2 of the 3 (above mentioned) criteria are met. Physicians will receive a copy of consent forms, educational bulletins, and discharge forms (as described in the Physician Education document which is attached to this application). Log-rank test will be used to compare groups. Chi-Square will be used to compare prospective patients with retrospective controls (obtained in 2010).

Eligibility Criteria:
Inclusion Criteria:

* Must have either Acute on Chronic Heart Failure or Chronic Heart Failure regardless of presenting/primary complaint

To fulfill CHF Dx, MUST have 2+ of the following:

* Clinical: Dyspnea, orthopnea, PND, edema, S3, rales, improve w diuretics
* Radiographic: Pulm venous congestion, pleural effs, cardiomegaly
* Lab: NT pro BNP \> 1000

Exclusion Criteria:

* None