cyrilzakka/clinical-trials huggingface dataset:
Multimodal Music Therapy for Children With Anxiety Disorders

Multimodal music therapy (MT) for children ages 8 to 12 years with anxiety disorders is compared to community treatment as usual (TAU). 36 children were randomized either to MT or to TAU. Primary outcome is presence of an anxiety disorder at the end of treatment. Secondary outcomes are self- and parent-/teacher reported anxiety, co-morbid psychological symptoms, and quality of life. Stability of outcome is assessed six months after the end of treatment.

Patients were enrolled in a community clinic and in an outpatient clinic for child and adolescent psychiatry/psychotherapy. Inclusion criteria: diagnosis of an anxiety disorder (separation anxiety disorder, general anxiety disorder, social phobia, specific phobia, or other anxiety disorder); age 8-12; no medication or stable medication during treatment; IQ\>80; informed consent of caregivers and informed assent of patients. Outcome measures. Kiddie-SADS; STAIC-C, SPAIC, CDI; SDQ teacher report; CBCL 4-18; ILK quality of life inventory. Assessment time points: pre-intervention; post-intervention; 6-months follow-up.

Eligibility Criteria:
Inclusion Criteria:

* age 8-12 years
* diagnosis of an anxiety disorder
* IQ\>80
* informed consent and assent

Exclusion Criteria:

* anxiety disorder is not primary focus of treatment
Transdiagnostic Group Therapy (GBAT) for Autistic Adults With Personalized Therapeutics

The purpose of this study is to build upon an earlier study that evaluated the use of a 10-week transdiagnostic Group Behavioral Activation Therapy (GBAT), a telehealth delivered intervention, as a cost effective and accessible way to treat symptoms of anxiety and depression in autistic adults. The current study will pilot and compare relative feasibility, acceptability, and preliminary efficacy of three adapted GBAT groups and a Watchful Waiting (WW) group. The three groups include GBAT+Individual (GBAT+I; individual sessions to supplement the 10 group sessions), GBAT+Engagement Booster (GBAT+E; supplemental materials), and GBAT+Both (GBAT+IE individual sessions and supplemental materials).


Eligibility Criteria:
Inclusion Criteria:

* Live in New Jersey or New York
* Be 18-40 years old
* Have a confirmed diagnosis of Autism Spectrum Disorders (ASD).
* Have access to a device (e.g., computer with a webcam or smartphone) in order to complete online surveys and participate in videoconference sessions
* WRAT Reading Comprehension grade equivalent 6th grade or higher
* Receive a best-estimate diagnosis of an anxiety or mood disorder (Generalized Anxiety Disorder, Social Anxiety Disorder, Specific Phobia, Panic Disorder, Agoraphobia, Major Depressive Disorder, Unspecified Depression, Persistent Depressive Disorder).
* Be interested in participating in an online telehealth treatment group to address their difficulties in the aforementioned areas
* Approximately 60% of our sample will be White, Non-Hispanic; approximately 40% of our sample will be female-identifying and 40% will be male-identifying

Exclusion Criteria:

* Are younger than 18 years old, or older than 40 years old
* Do not have an ASD diagnosis
* Have WRAT Reading Comprehension below 6th grade level
* Are unable to understand English fluently
* Have a principal DSM-5 disorder other than one of the above listed anxiety or depression disorders, have received a diagnosis of Intellectual Disability, schizophrenia, or bipolar disorder or demonstrate suicidal ideation or intent severe enough to require current hospitalization, or who have attempted suicide in the past 3 months.
* Are currently enrolled in another behavioral therapy or psychotherapy targeting depression, anxiety or anger.
* Are experiencing suicidal ideation that requires current hospitalization.
* The PI's best clinical judgment that it would not be in the adult's best interest to be enrolled (e.g., due to factors that may affect their engagement or comfort in the group).
Febrile Illness in Guinea

To date, the underlying causes of community-acquired fever, particularly non-malarial fever, are insufficiently documented in Guinea. Moreover, diagnostic capacity is limited, leading to inadequate prescription of antibiotics and antimalarials, as well as substantial delay in outbreak recognition. Thus, the investigators undertook a prospective observational multi-centric cohort study of febrile patients presenting at the emergency and outpatient department of selected health centers, districts and regional hospitals in four ecologically distinct sentinel health districts in Guinea.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥2 months old
* Documented fever (axillary temperature \>37.5°C) at presentation or fever reported within the prior 24 hours
* Availability for follow-up for 21 days
* Willingness and ability of the patient or culturally acceptable representative to give informed consent for participation in the study

Exclusion Criteria:

* History of hospitalization (for \> 48 hours within the last 14 days) at any health facility
Evaluation of Bortezomib Induced Peripheral Neuropathy of Multiple Myeloma (MM) Patients

In the present study we are planning to study electrophysiological changes related to the dose and time of bortezomib administration in newly diagnosed patients with MM, during the first months of treatment and 6 months after ending. In addition a possible correlation between the incidence of BIPN and the subtype of myeloma and other risk factors will be investigated.


Eligibility Criteria:
Inclusion Criteria:

* Age\> 18
* Patients with Multiple Myeloma stage II, III (Durie and Salmon staging) prior to Bortezomib Therapy
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
* Be willing and able to comply with the protocol treatment for the duration of the study
* Patient's written informed consent

Exclusion Criteria:

* Multiple Myeloma on progression
* Incidence of Relapsed or Refractory Myeloma
* Patients with the existing neuropathy at the time of the diagnosis
C-Brace II Spinal Cord Injury

A randomized, repeated measures comparative design study to compare use of a micro-processor controlled knee-ankle-foot orthosis vs. traditional care knee-ankle-foot-orthosis (KAFO) models following discharge from inpatient rehabilitation.


Eligibility Criteria:
All participants:

Inclusion Criteria:

* Be within 3-24 months post spinal cord injury diagnosis
* 18-80 years
* Must be able to demonstrate the ability to charge assigned sensors during 3-month home trial period on and off and sufficient memory ability to wear the devices each day during use of the orthoses.

Exclusion Criteria:

* Unstable neurological, cardiovascular, or cancer diagnoses.
* Cognitive impairments that limit study participation

In addition to the above inclusion criteria, the following criteria must be met to be designated into the study interventional tract (C-Brace II):

Inclusion criteria:

* Requires orthotic bracing for lower extremity instability, including the knee joint, unilaterally or bilaterally

Exclusion criteria:

* Body weight over 275 lbs
* Flexion contracture in the knee and/or hip joint in excess of 10 degrees
* Non-correctable knee varus/valgus in excess of 10 degrees
* Moderate to severe spasticity
* Leg length discrepancy in excess of 6" (15.24 cm)
* Inability to stabilize the trunk with or without assistive devices (crutches, cane, etc.)
* Inability to successfully use C-Brace trial tool in advancement of leg/s.
Effectiveness of Family-based Intervention for Youn Persons With Eating Disorders

This research project aims to characterize a naturalistic cohort of children and adolescents with eating disorders in terms of biological, psychological and psychopathological features. Further, the project will examine the effectiveness of treatment, the determinants of treatment outcome and the course of treatment response for children and adolescents with eating disorders (ED), treated in a generic specialist child and adolescent mental health service. The first choice of treatment is outpatient family-based treatment (FBT), which has documented effect for anorexia nervosa and bulimia nervosa. However, a subgroup of young persons with eating disorders does not respond sufficiently to this treatment, and evidence concerning effective treatment for children and adolescents with atypical eating disorders is still lacking. Further, treatment effectiveness for children and adolescents in a Danish naturalistic setting has never been examined.

The overall aim is to assess associations between patient characteristics and treatment response across the spectrum of eating disorders to identify, which patients benefit from family based treatment, and which patients possibly would need other kinds of treatment or more intensive care.

Research questions:

1. Which patient and family characteristics predict faster recovery from ED in childhood and adolescence?
2. Which patient and family characteristics predict intensification of treatment in the forms of day hospital or full hospitalization?
3. At which time point can recovery be predicted based on information from initial assessment and/or assessment during the course of treatment?
4. Which patient and family characteristics (e.g. patterns of comorbid symptoms) are common in those not responding well to treatment within each diagnostic category?
5. How many young patients migrate between ED diagnoses, and what characterizes these patients?
6. Studies on treatment effectiveness for EDNOS in children and adolescents are still lacking. Hence, an important research question of this study is whether family based treatment for EDNOS is effective and is perceived as helpful by patients and families?

   In addition, the project will seek to answer the following:
7. Is treatment effectiveness in The Capital Region of Denmark (BUC) comparable to published results from other countries in the same age group?

Eligibility Criteria:
Inclusion Criteria:

* begin treatment for eating disorder

Exclusion Criteria:

* lack of informed consent
Radiation-Free Technique for Evaluating Renal Scarring (RAFTERS)

In this research study the investigators want to study a safe, radiation-free technique known as contrast-enhanced ultrasound that may improve the ability to diagnose or evaluate renal scarring compared to regular ultrasound. This technique requires injection into a vein of a small amount of contrast material called Lumason. Contrast material is a type of dye that helps the investigators image the structures in the body more clearly. If this technique is successful, the need for DMSA studies may be avoided to diagnose or evaluate kidney scarring. DMSA is a more expensive test, causes radiation exposure, may require sedation and/or injection of contrast agents with the potential to cause allergic reactions.


Eligibility Criteria:
Inclusion Criteria:

* patients older than or equal to 6 months and less than or equal to 35 years old and scheduled for Boston Children's Hospital (BCH) DMSA scan to evaluate renal function and/or renal scarring

Exclusion Criteria:

* patients with significant congenital renal anatomical abnormalities including horseshoe kidney, kidney malrotation, and multicystic dysplastic kidney (MCDK). Patients with severe cardio-pulmonary diseases will also be excluded.
Effect of Eplerenone on Postprandial Inflammatory Response in Healthy Adults

The purpose of this study is to investigate the effect of mineralocorticoid receptor (MR) blockade in healthy participants in a systemic proinflammatory state after a meal high in fat and glucose, which is associated with the pathogenesis of atherosclerosis.

Participants will include normal-weight, healthy males (Body Mass Index (BMI) ≤ 25 kg/m\^2) between the ages of 18-45, without hypertension and clinical evidence of metabolic, cardiovascular or any other kind of diseases. After a 12-hour (h) fast, participants will be assigned to a combination of oral fat-loading test (OFLT) and oral glucose tolerance test (OGTT) (day 1), followed by a two-week treatment with 50 mg eplerenone. After two weeks, participants will receive the second OFLT/OGTT treatment (day 15). Starting 5 days prior to the first intervention (day1), the participant's usual diet (ad lib) will be supplemented with 2 bullion broths each day. Standardization of sodium intake is necessary as variations in dietary sodium intake may affect outcome measures. We will evaluate the following parameters at day 1 and day 15 of the study. Prior to OFLT/OGTT, and 2h, 4h thereafter, we will measure a parameter of vascular and systemic inflammation: interleukin-6 (IL-6).


Eligibility Criteria:
Inclusion Criteria:

* male
* 18-45 years
* BMI between 20-25 kg/m\^2

Exclusion Criteria:

* evidence of cardiovascular, hepatic, renal \[estimated glomerular filtration rate (GFR) \<60 millimeter/minute (ml/min)\] or any other organ system disease
* Blood pressure equal to or less than 90/60 mmHg
* prescription or herbal medications
* smoking
* alcohol consumption of more than 2 drinks per day
* dietary supplements
Micro-expressions in Patients With Prolonged Disorders of Consciousness

The goal of this observational study is to learn about the microexpressions in patients with prolonged disorders of consciousness. The main questions it aims to answer are:

* Inducing micro-expression changes in patients with prolonged disorders of consciousness through various emotional stimuli, and further to achieve precise classification of their levels of consciousness.
* Detecting micro-expressions in patients with prolonged disorders of consciousness to assist clinical diagnosis of levels of consciousness, e.g., complement the disgnosis of clinical scales such as CRS-r scale.
* By monitoring micro-expression changes in patients with prolonged disorders of consciousness, researchers can explore their residual brain function, thereby advancing research into relevant neural mechanisms.

Participants will be subjected to consciousness assessment by CRS-r scale, and their micro-expression changes in response to various emotional stimuli will be captured, along with the collection of EEG and MRI data. Follow-up evaluations will be conducted using the CRS-R scale and GOS scale, with a follow-up period of 6 months.

In accordance with the inclusion and exclusion criteria, a total of about 200 participants will be recruited, including about 150 confirmed cases of prolonged disorders of consciousness and 50 healthy control subjects (HCs). Utilizing the random split algorithm from the machine learning library sklearn, the dataset will be randomly divided into a training set (70%) and a testing set (30%). General information about the participants such as age, gender, time and location of injury, as well as medical history, family history, medication history, and surgical history will be collected.

Participants will undergo dual-person, multiple assessments using the CRS-R scale to evaluate auditory, visual, motor, speech responsiveness, communication, and arousal levels. Micro-expression changes in response to various emotional stimuli will be collected, along with EEG and MRI data.

Follow-up evaluations will be conducted on all enrolled patients using the CRS-R scale and the GOS scale, with a follow-up period of 6 months.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with consciousness disorders for more than 28 days following severe brain injury, assessed by the CRS-R scale to meet the criteria for VS or MCS;
2. Aged between 18 and 80 years;
3. Stable vital signs;
4. Voluntary participation of family members with signed informed consent;
5. Good cooperation, minimal facial and spontaneous activities, no use of antiepileptic or sedative drugs.

Exclusion Criteria:

1. Locked-in syndrome;
2. Contraindications for EEG examination;
3. Contraindications for MRI scanning, such as the presence of internal metallic implants;
4. Diseases and factors that may affect brain function assessment, such as metabolic disorders, poisoning, shock, etc.
Myocardial Ischemia and Transfusion Pilot

The purpose of this study is to evaluate two approaches to red blood cell transfusion in anemic patients with acute coronary syndrome.

Red blood cell transfusions are extremely common medical interventions, yet, it remains unclear when patients should be transfused. This pilot study will evaluate the feasibility of conducting a research protocol that will lead to a large scale clinical trial designed to evaluate the treatment effectiveness of two transfusion threshold strategies in patients with coronary artery disease.

Eligibility Criteria:
Inclusion Criteria:

* age 18 or older;
* STEMI (ST segment elevated myocardial infarction)
* NSTEMI (Non ST segment elevation myocardial infarction)
* unstable angina
* stable coronary artery disease (undergoing cardiac catheterization during the index hospitalization);
* written informed consent has been obtained
* hemoglobin concentration less than 10 g/dL at the time of random allocation.

Exclusion Criteria:

* bleeding cannot be controlled at the cardiac catheterization puncture site and/or require surgery to repair vessel
* retroperitoneal bleeding requiring surgery
* clinically important hemodynamic instability based on the judgment of the treating physician
* terminal malignancy or life expectancy less than 6 months
* scheduled for cardiac surgery within the next 30 days
* symptomatic at the time of randomization
* declines blood transfusion
* history of a clinically significant transfusion reaction
* inability to provide informed consent;
* enrolled in a competing study
* previous participation in the MINT trial
* any patient who in the judgment of the research team should not be enrolled in the trial. This would include, but not be limited to, factors such alcohol or drug dependence, or psychiatric illness.
Evaluating the Efficacy of Temperature-controlled Radiofrequency (TRF) in the Treatment of Vulvovaginal Atrophy.

This project will be a prospective, multicenter, randomized cohort study. The investigators will select patients with vulvovaginal atrophy who have indications for treatment, and set up the experimental group (Peninsula temperature-controlled radiofrequency therapeutic apparatus group) and the control group (promestriene vaginal soft capsules group). Changes in vaginal exfoliated cell maturity index (MV), score of vaginal symptoms and signs, vaginal health index score (VHIS), female sexual function index score (FSFI), visual analogue score (VAS) before and after treatment, and adverse effects will be observed to analyze the safety and efficacy of temperature-controlled radiofrequency therapy for vulvovaginal atrophy in postmenopausal women.


Eligibility Criteria:
Inclusion Criteria:

* Menopausal time at least one year.
* Genitourinary Syndrome of Menopause (GSM) related symptoms with moderate or severe intensity, such as dryness and dyspareunia, etc.
* Blood FSH≥30 IU/L (30mIU/mL)。
* Clinical symptoms and signs of vaginal atrophy score≥15.
* Breast ultrasound examination was grade 1-3 within 9 months before the study.
* Voluntary participation in clinical trials and signed informed consent.
* Patients followed the treatment regimen and completed the study.

Exclusion Criteria (one of the following criteria is excluded) :

* The patients who did not meet the inclusion criteria
* Received Estrogen replacement therapy (including local and systemic medication) within 3 months.
* Received any medicine (such as Baofukang suppository) to treat vulvovaginal atrophy within 3 months.
* Corticosteroids were used within 6 weeks. Long-term corticosteroids were used (intermittent nasal or skin application, eye drops and ears are allowed).
* Other experimental drugs were used within 1 month.
* Received vaginal laser therapy within 6 months.
* Patients with acute urinary tract infection;
* Patients with acute genital tract infection (genital herpes, trichomonad, fungal vaginitis; gonococcus, mycoplasma, chlamydia infection and bacterial vaginosis, etc.);
* Patients with pelvic organ prolapse greater than or equal to stage II;
* Patients with metal intrauterine device (IUD)；
* Patients with precancerous lesions or malignant tumors of vagina and cervix;
* Patients with serious heart, liver, brain, kidney, endocrine diseases, etc.
* Allergic to control drug and excipients.
* Other malignancies are known or suspected.
* With estrogen-dependent neoplasm.
* Confirm a history of depression or serious mental illness.
* There were consciousness barriers and communication barriers that could not cooperate with the experiment.
* Patients considered unsuitable for this clinical trial.
rTMS Efficacy Coupled With Mirror Therapy

Neuropathic pain is particularly difficult to treat with classic first-line drugs. Neuromodulation techniques using repetitive transcranial magnetic stimulation (rTMS) are useful alternative, but there is a need to improve their analgesic effect.Virtual reality mirror therapy has shown the capacity to alleviate pain and may be easily coupled with rTMS.The present project will investigate in individuals with neuropathic pain the effects of the rTMS coupled with virtual reality mirror therapy.

This project introduces a new research question that incorporates virtual reality mirror therapy into an established treatment protocol of repetitive transcranial magnetic stimulation (rTMS) for neuropathic pain relief. Neuropathic pain is particularly difficult to treat with classic first-line drugs. Neuromodulation techniques using repetitive transcranial magnetic stimulation (rTMS) are useful alternative, but there is a need to improve their analgesic effect.

Virtual reality mirror therapy has shown the capacity to alleviate pain and may be easily coupled with rTMS. The efficacy of using both techniques in neuropathic pain treatment is unknown. The present project will investigate in individuals with neuropathic pain the effects of the rTMS coupled with virtual reality mirror therapy on: 1) daily pain intensity (i.e. analgesic efficacy); 2) other components of pain and the quality of life; 3) brain activity.

It will be the first to provide insight into the efficacy of using together both non-invasive technics of cortical neuromodulation to alleviate pain.

Eligibility Criteria:
Inclusion Criteria:

* Clinical symptoms typical of neuropathic pain
* Refractory to drug therapies
* Lasting for at least 6 months, with a moderate to severe pain intensity (≥4/10 on Visual Analog Scale, VAS) and a stable pain treatment since 1month at least
* Having right to health benefits

Exclusion Criteria:

* Ferromagnetic components and implanted microprocessors (i.e. cochlear implants)
* Drug-resistant or active epilepsy, pacemaker, pregnancy, ongoing depression or personality troubles, and ongoing opioid treatment.
* Any other contraindications to MRI scanner (e.g., claustrophobia, etc.).