cyrilzakka/clinical-trials huggingface dataset:
Neurocytotron on Cerebral Palsy

This is a randomized, double-blinded, two-arm, placebo-controlled clinical study. The enrollment will be randomized 1:1 to Neurocytotron treatment or mock treatment (placebo).

Upon the completion of the study period, the placebo group will receive treatment, if the study results show benefits to patients.

The study proposes to investigate the use of non-thermal and non-radioactive radiofrequency pulses in the brain for improving the symptoms of cerebral palsy. The proposed treatment will deliver radiofrequency pulses to the brain of patients in a non-invasive manner. The duration of the treatment will be 1 hour per day, for 28 days. After treatment, participants will be monitored for two months to detect potential adverse events and any signs of symptoms improvement. The study will be closed once 48 subjects complete the study. At the end of the study, the placebo group will have the opportunity to receive treatment with the Neurocytotron, based on the benefits shown by study results.

Eligibility Criteria:
Inclusion Criteria:

1. Informed Consent Form approved by the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) signed and dated by the subject or the subject's legal representative and by the Principal Investigator. This must be obtained before the performance of any study-related procedures that are not part of normal participant care.
2. Patients 1 to 8 years old (We will include this age range because children with CP less than 1-year-old have a high mortality rate, in addition, the clinical evolution stabilizes after the second year of life, and the potential effect of treatment is optimized in the first 5 years).
3. A clinical diagnosis of spastic cerebral palsy, or spastic and dyskinetic, secondary only to hypoxic/ischemic encephalopathy
4. For spasticity, having scored at least 3 on the Ashworth scale, and 3 on the gross motor scale.
5. For dyskinesis, any degree.

Exclusion Criteria:

1. Patient with diagnosis of ataxia.
2. Current or recent history (within 2 months) of significant bacterial, fungal, viral, or mycobacterial infection.
3. Having a condition considered as causing or likely to cause co-morbidities, as determined by the investigator based on medical history, physical examination, vital signs, and clinical laboratory tests.
4. Subject with magnetic implants, pacemakers, claustrophobia or any other condition that precludes them from entering or staying in the NeuroCytotron.
5. Surgical history related to spasticity treatment.
6. Patients who have received treatment with botulinum toxin in the last 6 months.
7. 7. Children with prior neurosurgery within the past 6 months at the time of evaluation.
8. History of malignancy.
9. History of congenital heart disease.
10. Subjects who cannot or are unlikely able to comply with the protocol, according to the consensus reached by the group of study investigators.
Comorbidity and Pulmonary Rehabilitation in COPD

Our aim in this study is to determine the distribution of comorbidity in patients with COPD participating in the pulmonary rehabilitation program and to examine the effect of severity of comorbidy on pulmonary rehabilitation outcomes.

Chronic Obstructive Pulmonary Disease (COPD) is associated not only with respiratory system effects but also with systemic outcomes leading to numerous chronic comorbidities, and it is well known that patients benefit from pulmonary rehabilitation programs. However, the effect of presence of comorbidity on the outcome of pulmonary rehabilitation in patients with COPD is not clear. Therefore, our aim in this study is to determine the distribution of comorbidity in patients with COPD participating in the pulmonary rehabilitation program and to examine the effect of severity of comorbidy on pulmonary rehabilitation outcomes We included a total of 173 patients referred to the Izmir Suat Seren Chest Diseases and Surgery Training and Research Hospital Pulmonary Rehabilitation Unit. Comorbidities were recorded based on self reports. Charlson Comorbid Indexes (CCI) were calculated. Patients who defined at least one comorbidity were divided into two groups according to CCI; 1-3 as Group 1 and 4 and above as Group 2. Six minute walk test, mMRC dyspnea scale, SGRQ Respiratory Disease Questionnaire, respiratory function tests and arterial blood gases performed for assessment of patients before and after 16 sessions of pulmonary rehabilitation program.

Eligibility Criteria:
Clinical Trial Evaluating Safety and Efficacy of Resomelagon on Dengue Infection (RESOVIR-2)

The goal of this clinical trial is to understand if Resomelagon can treat adult patients with Dengue virus infection. The main questions the investigators aim to answer are:

Is Resomelagon safe to use in patients with Dengue? Is Resomelagon able to reduce the duration of illness? (defined by clinical and laboratory criteria) Participants will be allocated to Resomelagon or placebo groups in this study and asked to take the medication and submitted to blood tests.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are 18 to 65 years old;
* Able to understand study procedures and give informed consent;
* Presents with more than 36 and less than 84h since symptoms onset;
* Symptoms compatible with dengue infection (fever, myalgia, arthralgia, headache or conjunctivitis) with positive antigen test or polymerase chain reaction test.

Exclusion Criteria:

* Has any comorbidity which is perceived as significant by the investigator;
* Significant laboratory abnormalities discovered at triage: Hemoglobin \<10g/dL; Platelet count \< 50.000/microL; alanine transaminase \> 3x upper limit of normal; Total bilirubin \>1,5 x upper limit of normal; glomerular filtration rate \< 60mls/min/1,73m2;
* Contraindications or known hypersensitivity to Resomelagon;
* Presents as dengue with warning signs or severe dengue at inclusion;
* Currently participating in another drug clinical trial;
* Clinical evidence of another infection that might explain current symptoms;
* Pregnant women or women actively trying to achieve pregnancy.
Switching From Consta® to Sustenna® in Patients With Schizophrenia

The aim of this study is observation of effectiveness and side effect of patients with schizophrenia who will switch the antipsychotics from risperidone long acting injection to paliperidone palmitate.

In this study, investigators are going to enroll the patients who will switch the risperidone long acting injection to paliperidone palmitate. And investigators will examine the effectiveness and side effect of paliperidone palmitate. In addition, effectiveness and side effect related variables will be studied.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18 \~ 65
* Patient with schizophrenia according to DSM-IV criteria
* Patient have signed on the informed consent, and well understood the objective and procedure of this study.
* Maintenance therapy more than 6 months with Risperidone Long Acting Injection monotherapy or other with concomitant antipsychotics, and stable dose of Risperidone Long Acting Injection was maintained 8 weeks more. The stable dose of other antipsychotics has been maintained 8 months and more.
* Patient wants to switch antipsychotics to Paliperidone Palmitate.
* PANSS total score ≤ 80
* Each score of conceptual disorganization(P2), hallucinatory behavior(P3), Suspiciousness/persecution(P6), unusual thought content(G9)in PANSS ≤ 4
* Competent patient who is manage to answer the questionnaires.
* In case of female at child-bearing age, consent to use appropriate contraceptive methods(oral pill, contraceptive injection, intrauterine device, double barrier method and contraceptive patch) during entire duration of this study.

Exclusion Criteria:

* No history of antipsychotics use.
* Past history of NMS.
* Allergy or hypersensitivity to Risperidone or Paliperidone ER.
* Concomitant antipsychotics was oral Risperidone or Paliperidone ER.
* Initiating or dose-changing of SSRI, MAOI, TCA within 2 months(maintenance is allowed if those have been stable for at least 30days prior to study entry and would not be any dose changes during the study)
* Initiating of Lithium, Valproic acid, Carbamazepine, Topiramate, Lamotrigine or other mood stabilizer within 2months (maintenance is allowed).
* Patient who is supposed to be impossible to participate to this study due to clinical risk of suicide or aggressive behavior based on clinician's opinion.
* Current substance dependence(DSM-IV) or past history of dependence (more than 6months)
* Significant biochemical or hematological abnormality or abnormal finding of urinalysis, based on clinician's opinion.
* History of cardiac disease which predispose to QT prolongation(sick sinus, complete AV block, CHF, ventricular tachycardia, hypokalemia or hypocalcemia) or current medication of QT prolonging drugs
* Pregnant or breast-feeding female patient.
* History of participating to other investigational drug trial within 1month prior to screening.
* Investigator or employee at clinical trial center, personnel related to investigator or trial center on this or other study, or family of employee or investigator
Nightmare Deconstruction and Reprocessing Pilot

This is a single-arm, multisite (2 sites) pilot trial that is evaluating Nightmare Deconstruction and Reprocessing (NDR) for treating posttraumatic nightmares and insomnia in up to 30 military service members and veterans. Study aims are to test NDR's plausibility and tolerability and to test methodologic feasibility of collecting heart rate variability (HRV), electrodermal activity (EDA), and actigraphy data via a wristband device and peripheral blood samples within a pre-specified circadian window. Treatment consists of 8 sessions over 8 weeks. Participants are assessed at study visits 0, 1, and 7 and 1-month follow-up. Psychometric assessments include the Disturbing Dreams and Nightmare Severity Index, Pittsburgh Sleep Quality Index, and Clinician-Administered PTSD Scale for DSM-5.

The current study is testing NDR, a three-stage treatment that integrates exposure, reprocessing, and rescripting of nightmare images to alleviate nightmare and insomnia severity. Study aims are to test NDR's plausibility and tolerability and to test the methodologic feasibility of collecting daily HRV, EDA, and actigraphy data via the E4 wristband as well as peripheral blood samples for assay at three time points. Participants are active duty military or veterans (N = 30) ages 18 to 64 with posttraumatic nightmares and insomnia. Participants undergo 8 NDR treatment visits over 8 weeks and complete a 1-month follow-up. Psychometric measures of nightmare (Disturbing Dreams and Nightmare Severity Index) and insomnia (Pittsburgh Sleep Quality Index) are administered at each visit. Objective measurement of sleep disturbance is done via the Empatica E4 wristband. In-session distress is measured using the 1-item Subjective Units of Distress Scale (SUDS), and E4 HRV and EDA data during exposure to nightmare images. BDNF, IL-2, IL-6, and TNF alpha are being assayed from blood samples taken immediately after Visit 0 (baseline), Visit 1 (first in-session exposure to nightmare images), and Visit 7 (final in-session exposure to nightmares). To control for circadian factors regulating the expression of BDNF and inflammatory cytokines, all blood samples are collected between 0900 and 1200.

Eligibility Criteria:
Inclusion Criteria:

* Active duty servicemembers and DEERS-eligible veterans
* DDNSI score ≥ 10
* PSQI score \> 5

Exclusion Criteria:

* Current imminent risk of suicide
* Psychotic or bipolar disorders
* Untreated moderate to severe sleep apnea/hypopnea, circadian rhythm disorders, or narcolepsy
* Current use of prazosin for nightmares
* Self-reported alcohol use \> 4x/ week and \> 3 drinks per occasion
* Concurrent evidence-based or experimental treatment directly targeting nightmares, insomnia, or PTSD
* Initiation of or change in psychotropic medications for PTSD, nightmares, insomnia, depression, or anxiety in the past 8 weeks
* Inability to recall nightmare content
* Inability to comply with requirement to wear E4 wristband and upload daily
Retrospective Analysis of Spray Skin Treats for Severe Burns

This study investigated the efficacy of novel approach spray skin for extensive severe burns treatment.

Burns are a global public health problem. This study investigated the efficacy of novel approach spray skin (autologous skin cell suspension combined with split-thickness skin grafting, STSG) for extensive severe burns treatment.

We performed a real-world retrospective analysis of extensive burns patients (\> 50% TBSA) from our hospital last 10 years.

Eligibility Criteria:
Inclusion Criteria:

* patients with \> 50% TBSA

Exclusion Criteria:

* died within 1 week after admission
* admitted to hospital more than 1 week after injury
Effectiveness Study of Videoconferencing on Teaching Parent Training Skills to Parents of Children With Attention Deficit Hyperactivity Disorder (ADHD)

The purpose of this study is to evaluate the effectiveness of group parent training taught through videoconferencing on ADHD treatment via a comparison between participants using traditional face-to-face parent training sessions and a group using teleconferencing.

Subjects with a primary diagnosis of ADHD between the ages of 6 and 14 years were enrolled. All subjects were screened and assessed for psychiatric and learning disorders using structured interviews (DICA, parent and child version, Reich et al, 2000) based on DSM IV criteria and parent and teacher rating scales. Mothers took the Beck Depression Inventory (BDI) to assess for depression.

Parents or primary caregivers were randomized to two treatment arms (videoconference or face to face). Ten sessions of weekly parent training through either videoconference or face-to-face delivery was conducted using Dr. Russell A. Barkley's manual. A non-mandatory skill training and play group was offered to the children of both groups while parents attended the parent training group in order to provide child care for the parents during the training sessions.

Following outcomes will be measured to assess the effectiveness of the intervention:

Primary outcome Acceptance of the parent and children on the mode the communication as well as parent training.

Secondary outcomes:

1. Parent-child relations measured by the Parent Child Relationship Questionnaire (PCQ)
2. The Vanderbilt Assessment Scale (parent \& teacher versions), Children Global Assessment Scale (CGAS), Clinical Global Impression- Severity score (CGI-S), and Clinical Global Impression-Improvement Scores (CGI-I) assessed the severity of core symptoms of ADHD and oppositional/aggressive symptoms.
3. The parent and teacher-rated versions of the Social Skills Rating System (SSRS) assessed social skills.

Eligibility Criteria:
Inclusion Criteria:

* DSM-IV criteria for any subtype of ADHD.
* ADHD must be the primary diagnosis if there is comorbidity.

Exclusion Criteria:

* Subjects with significant medical conditions, which are not stable on current outpatient treatment regimen.
* Subjects with severe psychiatric disorders (i.e., bipolar disorder, autism, schizophrenia, major depression).
Optimum-pressure for Reducing Postoperative Shoulder-tip Pain in Laparoscopic Cholecystectomy

Laparoscopic cholecystectomy (LC) is the standard treatment of gallbladder disease. LC is the common procedure for general surgeons. Although LC is a safe procedure with very low mortality (\<1%), it has some associated major morbidity. Bile duct injury is the most serious complication of LC. However, there are some postoperative morbidity including shoulder-tip pain. The incidence of shoulder-tip pain is about 15-45%, which might be influencing the patient outcome including length of hospital stay. From the previous studies, one of the important factor associated with this condition is pneumoperitoneum pressure. Thus, the suggestion of the intra-abdominal pressure should be low pressure as about 8 mmHg. However, the optimum pressure for the low-pressure during laparoscopic cholecystectomy is controversial.

We designed the prospective randomized controlled trial to comparing the postoperative shoulder tip pain between two low pressure level (8 and 10 mmHg) during laparoscopic cholecystectomy. After the enrolled participant signed the inform consent, the participant was randomly assigned to 8 or 10 mmHg group. The standard procedure of the laparoscopic cholecystectomy was performed by experience surgeons. During the operation, the pressure limit can be adjusted to facilitate the procedure according to the surgeons. Following the operation, the investigator will ask about the shoulder tip pain from the participant during 48 hours. The standard of care including pain medication during postoperative period was performed.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 15 years
2. Elective procedure of laparoscopic cholecystectomy
3. Sign to Inform consent

Exclusion Criteria:

1. Emergency surgery
2. Concomitant other procedure performed
3. Deny to participant
Feasibility and Evaluation of a Self-care App to Enhance Purposeful Living

In this pilot study, ovarian cancer survivors will be enrolled and followed for six months to evaluate usage of an eHealth app called "Purposeful".

This study will determine the feasibility and acceptability of Purposeful, the eHealth app. First, feasibility of enrolling ovarian cancer survivors to use Purposeful will be assessed. Secondly, the acceptability of the app among ovarian cancer survivors will be assessed, based on frequency of use and validated acceptability measures. Participants will be asked to complete other validated questionnaires so investigators may explore whether further research on the Purposeful app among ovarian cancer survivors is warranted. This will include correlations between use of the Purposeful app and the life purpose questionnaire score. Lastly, correlation between life purpose and quality of life in ovarian cancer survivors will be explored.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ovarian cancer or treatment for ovarian cancer through the University of Michigan Gynecologic Oncology service
* Completed primary treatment (either surgery alone or surgery + chemotherapy)
* Ability to understand and the willingness to sign a written informed consent
* Ability to speak and read English

Exclusion Criteria:

* There are no additional exclusion criteria for participation in this study.
Two Treatment for a Mallet Finger of Tendinous Origin

A randomized clinical trial, with patients treated either by a custom thermoplastic orthosis or by the Kirschner wire with the distal interphalangeal (DIP) joint extended.

Evaluating the treatment efficacy of the operation management compared with a conventional orthosis.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of a mallet finger, with or without fracture;
* Age≥18 years

Exclusion Criteria:

* Open lesions
* Mallet fractures with subluxation of the DIP
* Delays in treatment \>2 weeks
* DM
* RA
Modified Thoracoabdominal Nerve Plane Block In Living Liver Donors

Ultrasound-guided Modified Thoracoabdominal Nerve Plane Block (M-TAPA) is performed deep into the costochondral aspect at the 9th-10th costal level by injecting local anesthetics deep into the chondrium. It provides blockage of both the anterior and lateral cutaneous branches of the thoracoabdominal nerve. As there are studies showing M-TAPA block to be effective for postoperative analgesia for other abdominal surgeries, its effect on patients undergoing living liver donor surgery has not been studied yet. We hypothesize that M-TAPA block performed in living liver donors would reduce opioid consumption in the first 48 hours after surgery.

Open hepatic resection for living liver transplantation donor surgery can cause severe postoperative pain and if not treated properly, may increase the risk of chronic pain development, which has a significant impact on the patient's daily life quality. The use of interfascial plane blocks for pain control has increased in recent years, as ultrasonography (USG) has become a part of daily routine. Interfascial plane blocks provide effective postoperative analgesia. Additionally, reducing postoperative opioid consumption may be a useful strategy to provide hemodynamic stability and promote early mobilization. Case reports state interfascial plane blocks to be effective and safe for providing effective analgesia compared to systemic analgesia in living liver donor surgeries. As studies are showing M-TAPA block to be effective for postoperative analgesia for other abdominal surgeries, its effect on patients undergoing living liver donor surgery has not been studied yet. We hypothesize that the M-TAPA block performed in living liver donors would reduce opioid consumption in the first 48 hours after surgery.

Eligibility Criteria:
Inclusion Criteria: Patients American Society of Anesthesiologists (ASA) classification I- II Scheduled for living liver donation surgery for liver transplantation under general anesthesia

Exclusion Criteria: Patients

* with history of bleeding diathesis,
* receiving anticoagulant treatment,
* with allergies or sensitivity to drugs used,
* with an infection on the puncture site
* who do not accept the procedure or participate in the study
Comprehensive Frailty Assessment

The purpose of this research study is to describe a patients' fitness before and after treatment (whether that treatment be chemotherapy or a transplant). Fitness is a way of measuring a patient's current quality of health. With surveys, questionnaires and blood tests, we hope to create a tool that will give a good picture of patients' ability to tolerate treatment. In the future, we hope to devise the best treatment for a patient based on their "fitness".


Eligibility Criteria:
Inclusion Criteria:

* patients with a plasma cell dyscrasia AND/OR any patient receiving a stem cell transplant for a hematologic malignancy at The Ohio State University
* at least 18 years of age

Exclusion Criteria:

- Any medical or psychiatric condition that would make it difficult for the patient to comply with study procedures.
Enhanced Critical Care Air Transport Team Training for Mitigation of Task Saturation

This study involves two tasks. The first involves observation of patient care during simulated aeroevacuation missions in order to gauge task saturation. The second involves review of records from actual evacuation flights in order to determine the effects of task saturation on patient care.


Eligibility Criteria:
Inclusion Criteria:

* Enrollment in a US Air Force CCATT Advanced Class at University Hospital, Cincinnati