cyrilzakka/clinical-trials huggingface dataset:
Novel Adaptive Cognitive Training in Autistic Adults with Co-occurring Insomnia

The proposed study will test the usability and feasibility of a novel cognitive training (COGMUSE) for autistic adults with co-occurring insomnia (COGMUSE- AUT). Participants (n=15) will complete the cognitive training intervention for 60 minutes per day, 3 times per week for 6 weeks at home totaling to 18 hours. Weekly check-ins will be conducted by study staff over Teams to ensure adherence to the treatment and provide an opportunity for qualitative feedback on the game sessions played. During these 6 weeks, participants will fill out daily (2x/day) electronic sleep diaries and wear an actigraph device (GENEActiv). GENEActiv is a watch-like device that monitors light and movement activity.


Eligibility Criteria:
Inclusion Criteria:

1. 18+ years of age
2. Diagnosed with ASD (see 2a).
3. Verbal IQ \>= 70 (Measured via the Weschler Abbreviated Scale of Intelligence 2nd Edition28); to ensure verbal skills sufficient to participate in treatment
4. Able to undergo actigraphy assessment
5. Can read and understand English
6. Diagnosed with insomnia (See 3a).
7. No prescribed or OTC sleep medications for 1+ month, or stabilized on medications for 6+ weeks.

2a) ASDb: a) previous DSM diagnosis of ASD (self-reported by ASD adult and guardian; confirmed by clinical documentation provided to project coordinator), 2) evaluation using gold-standard diagnostic tools (i.e., Autism Diagnostic Observation Schedule (ADOS) and/or Autism Diagnostic Interview -Revised \[ADI-R\]).

3a) Insomnia: a) insomnia complaints for 6+ months that b) occur despite adequate opportunity and circumstances for sleep, c) consist of 1 or more of the following: difficulty falling asleep, staying asleep, or waking up too early, d) daytime dysfunction (mood, cognitive, social, occupational) due to insomnia, f) baseline diaries and actigraphy indicate \>30 minutes of sleep onset latency or wake after sleep onset on 6 or more nights.

Exclusion Criteria:

1. unable to provide informed consent
2. diagnosis of sleep disorder other than insomnia \[i.e., sleep apnea (apnea/hypopnea index, AHI \>15), Periodic Limb Movement Disorder (myoclonus arousals per hour \>15)\],
3. comorbid bipolar or seizure disorder (due to risk of sleep restriction treatment)
4. other major psychopathology except depression or anxiety (e.g., suicidal ideation/intent, psychotic disorders)
5. severe untreated psychiatric comorbidity
6. psychotropic or other medications (e.g., beta-blockers) that alter sleep
7. participation in non-pharmacological treatment (including CBT) for pain, sleep or mood outside current trial.
An Observational, Multicenter Study to Evaluate the Use and Effectiveness of Doptelet® in Patients With ITP

This is a multi-center, observational, Phase 4 study in patients with Immune Thrombocytopenia (ITP) designed to describe the real-world effectiveness of Doptelet and assess the patterns of drug utilization to add to the knowledge base regarding the use of Doptelet in routine medical practice. Patients eligible for participation will, as part of their routine medical care, be receiving Doptelet for the treatment of ITP.

This is a multi-center, observational, Phase 4 study in patients with ITP designed to describe the real-world effectiveness of Doptelet and assess the patterns of drug utilization to add to the knowledge base regarding the use of Doptelet in routine medical practice.

Patients eligible for participation will, as part of their routine medical care, be receiving Doptelet for the treatment of ITP.

The scope of the study is to collect both retrospective and prospective data. The main part of the study will be prospective collecting data on usage, effectiveness, safety, patient- and clinician-reported outcomes and health economic parameters whereas the retrospective part will consist of collection of information on previous treatments, reason for treatment switch, healthcare resource use and, if applicable, Doptelet treatment prior to enrollment. The retrospective data collection will be based on the information available in the patient's medical records. Data will be collected for up to 12 months prior to Doptelet treatment start.

Prospective data will be collected at routine clinical visits throughout the study. Patients will be followed for 12 (+6) months and will be enrolled until their first scheduled visit after 12 months of enrollment, or until early termination, whichever occurs first.

Eligibility Criteria:
Inclusion Criteria:

1. Patient is ≥18 years of age
2. Established and well documented ITP diagnosis
3. Patient is treated with, or at enrollment prescribed, Doptelet for ITP. Decision to initiate treatment shall be made by the treating physician and independently from the decision to include the patient in the study
4. Signed and dated informed consent provided by the patient before any study-related activities are undertaken
5. Willing and able to comply with protocol requirements

Exclusion Criteria:

1. Enrollment in a concurrent clinical interventional study, or intake of an Investigational Medicinal Product (IMP), within three months prior to inclusion in this study
2. ITP secondary to Evan's syndrome, lupus and other autoimmune diseases
3. ITP secondary to other hematological disorders and hematological malignancies
4. ITP secondary to any other malignancies
5. ITP secondary to known drug toxicity
6. ITP secondary to any other disease considered relevant by the Investigator
Use of Virtual Reality Game in Rehabilitation of Stroke Patients in Tan Tock Seng Hospital

Use of SIlverfit 3d to aid in rehab of stroke patients focusing on their shoulder and knee strength

Either 1 of 3 physiotherapists will recruit the patient from NICU if the GCS is 14 - 15. Silverfit 3D will then be used for 20 minutes each day to train the knee and arm strength until the patient's discharge from ICU. Baseline muscle strength will be measured and graded by the physiotherapist using Medical Research Council grading then followed up by the same physiotherapist on discharge from ICU and on discharge from hospital.

Eligibility Criteria:
Inclusion Criteria:

* Patients 21 - 90 years old
* Diagnosis of stroke of pure motor/sensory type affecting the limbs, all levels of severity and at all stages post stroke, defined by the WHO as "a syndrome of rapidly developing symptoms and signs of focal, and at times global, loss of cerebral function lasting more than 24 hours or leading to death with no apparent cause other than that of vascular origin" (WHO 1989), diagnosed by imaging or neurological examination
* GCS 14 - 15
* RASS -1 to +1
* Blood pressure within 20% of patient's baseline
* Muscle power at least 2 out of 5 on the affected side, as assessed by the physiotherapist or clinician

Exclusion Criteria:

* Age less than 21 or more than 90 years old
* Neurological instability
* Poor prognosis/expected withdrawal of treatment/palliative care patient
* Visual loss/hearing loss
* Active delirium with inability to cooperate as determined by CAM-ICU positivity
* Severe cognitive impairment/dementia
* Haemodynamic instability
Open Label, Dose-Regimen Study Evaluating Etanercept 50 mg Once-Weekly In Japanese Subjects With RA

The primary purpose of this study is to evaluate the safety and efficacy of a once-weekly dose of etanercept for rheumatoid arthritis. Currently, patients in Japan can only use 25 mg etanercept two times a week. If a once-a-week regimen of 50 mg is approved, this would be more convenient for most patients. This once-weekly regimen is used in countries outside of Japan.


Eligibility Criteria:
Main Inclusion Criteria:

* Subjects of Japanese ancestry and living in Japan.
* Subjects who are receiving the approved dose of 25 mg etanercept BIW for at least 6 months and have stable disease activity, as determined by investigator's judgment for 3 months before test articles administration.
* Subjects who have mildly active rheumatoid arthritis as demonstrated by 5 swollen joints and 5 tender/painful joints.

Main Exclusion Criteria:

* Prior treatment with Disease Modifying Anti-Rheumatic Drugs (DMARDs) and/or methotrexate (MTX) within 6 months of the baseline visit.
* Subjects considered being in disease remission, per investigator's judgment.
* Received other biological drugs, rituximab, anti-CD-4 agents, or diphtheria interleukin-2 fusion protein (DAB-IL-2) within 6 months prior to baseline.
Antisense Oligonucleotide for Spinal Muscular Atrophy

This is a longitudinal, multiple-center, observational study of patients genetically confirmed chromosome 5q SMA to monitor the efficacy, safety, tolerability of SPINRAZA® (nusinersen) for up to 24 months.

SPINRAZA® (nusinersen) is an antisense oligonucleotide (ASO) designed to treat SMA caused by mutations in chromosome 5q that lead to SMN protein deficiency. Nusinersen, approved by the FDA for treatment of SMA in 2016, was approved by the Chinese National Medical Products Administration in 2019.

This is a prospective, longitudinal, multi-center, observational study designed to evaluate the efficacy, safety, tolerability and of nusinersen in patients genetically confirmed chromosome 5q SMA in China. Subjects with SMA I/II/III who are planning to initiate treatment with nusinersen will be enrolled in this study. All patients will be treated by their physicians according to standard clinical practice. SPINRAZA® (nusinersen) is administered as an intrathecal injection. A total of 5ml of cerebrospinal fluid (CSF) will be removed prior to administration of SPINRAZA® (nusinersen), which will be collected by the study. Neurofilament light chain (NfL) in CSF and blood will be assessed for the efficacy of nusinersen, as well as motor and pulmonary function.

There will be a total of nine visits. All the patients with 5q SMA receiving nusinersen will be visited face to face at baseline, day 14, day 28 and day 63 after treatment initiation, and then 4-month intervals through month 24/22.

Eligibility Criteria:
Inclusion Criteria:

* Patients genetically confirmed 5q SMA including types I, II and III, who are planning to initiate treatment with SPINRAZA® (nusinersen) as part of their clinical care plan.
* Non-5q SMA patients undergoing clinical standard lumbar puncture
* Non-SMA subjects including Asymptomatic carriers of SMA, relatives of SMA patients and carriers, and patients undergoing clinical standard lumbar puncture
* Participants or Parent(s)/legal guardian(s) willing and able to complete the informed consent process

Exclusion Criteria:

* Contraindication for lumbar puncture
* Inability to access intrathecal space for nusinersen injection
Johns Hopkins Breast Cancer Program Hormone Therapy Longitudinal Database

The purpose of this project is to establish a repository of information and samples from breast cancer patients or those at high risk of developing breast cancer, who are initiating hormone therapy as part of standard clinical care or prevention. This repository will include patient reported outcomes and other questionnaires, information on medication use, data about adherence to the hormone therapy and tumor characteristics, including prospectively collected samples.

This research is being done to learn more about the side effects of breast cancer hormone therapy and if a person's genetic information may help us to develop a way to predict the side effects a patient may have and how best to treat them. In addition, the investigators hope to look at how the side effects from hormone therapy influence a patient's willingness to continue hormonal treatment.

Men and women being prescribed hormone therapies including Tamoxifen, Raloxifene (Evista), Anastrozole (Arimidex), Letrozole (Femara), or Exemestane (Aromasin), by their oncologist for either prevention of breast cancer or treatment of breast cancer may join.

The decision of which hormone therapy to receive is the decision of the patient and physician, this study will collect samples and patient-reported outcomes during this routine, standard of care and will not direct any treatment decisions or interventions in any way.

Eligibility Criteria:
Inclusion Criteria:

* Male or female
* 18 years of age or older
* Physically and cognitively able to complete the questionnaires
* Meet one of the following categories: 1) Initiating hormonal therapy for breast cancer prevention. All patients planned to initiate hormonal therapy with either Tamoxifen, Raloxifene (Evista®), Anastrozole (Arimidex®), Letrozole (Femara®) or Exemestane (Aromasin®) are eligible; concomitant use of Zoladex or Lupron is permitted; 2) Patients with histologically proven ductal carcinoma in situ (DCIS/stage 0) or stage I-III invasive carcinoma of the breast that is estrogen (ER) and/or progesterone (PR) positive by immunohistochemical staining, who are considering one of the above listed SERMs or AIs. These patients must have completed any planned chemotherapy and local therapy (e.g., lumpectomy or mastectomy); however, enrollment/initiation of hormonal therapy on study may be done prior to completion of radiation and/or biologic therapy (e.g., trastuzumab) at the discretion of the treating team; or, 3) The patient is aware of the nature of her diagnosis, understands the study regimen, its requirements, risks, and discomforts, and is able and willing to sign an informed consent form.
* Patients transitioning from one hormonal agent listed above to another may be enrolled prior to initiation of the new medication.

Exclusion Criteria:

* N/A
Comparative Study of MCCE With/Without Tether vs Conventional Upper Endoscopy in Patients With Upper Abdominal Symptoms

A prospective single blinded, tandem study, comparing a magnetically controlled capsule with or without a tether (MCC or MCC-T) with conventional upper endoscopy for the diagnosis of patients with upper abdominal symptoms.

In the US patients commonly undergo esophagogastroduodenoscopy (EGD) for upper abdominal symptoms to try to resolve whether they have gastroesophageal reflux disease or functional dyspepsia, if they are older than the age of 60 with symptoms, or have alarm symptoms such as unexplained weight loss, persistent nausea and vomiting or if they have symptoms that are refractory to acid suppression therapy. Given the increasing burden of digestive disease in the US, the use of EGD is increasing in volume nationwide. EGD usually requires either conscious sedation or monitored anesthesia sedation, which has put an additional cost burden on the healthcare system. Since MCC or MCC-T does not require sedation, it offers an attractive option for both patients and clinicians alike.

The aim of this study is to compare in the same patient the accuracy of the MCC and MCC-T and EGD in patients presenting with upper abdominal symptoms.

Eligibility Criteria:
Inclusion Criteria:

1. Patient is able to provide informed consent
2. Patient has appropriate indications for EGD including symptoms of, but not limited to upper abdominal pain, acid reflux, heartburn, iron deficiency anemia, weight loss, bloating, belching, nausea, vomiting and atypical chest pain.

Exclusion Criteria:

1. Patient with dysphagia.
2. Patient with previous intestinal surgery.
3. Patient with Crohn's disease or other potential obstructive conditions, unless there is a recent CTE, MRE or patency capsule performed to exclude an obstructive lesion that may retain the capsule.
4. Female patient who is pregnant.
5. Patient with implanted medical device that would be potentially affected by magnets or radiofrequency emissions (e.g., pacemakers, implanted cardiac defibrillators).
Impact of Large-Volume Pleural Effusions on Heart Function

The physiologic basis for relief from dyspnea after therapeutic thoracentesis remains poorly understood. Improvement of the heart and lung function may contribute to the dyspnea relief. But there is no data support this phenomenon. Transthoracic echocardiogram (TTE) is a non-invasive viewing of the heart, which can quickly assess the heart function through real-time images. The investigators performed thoracentesis on patients with large-volume pleural effusions, and utilized TTE to access the change of heart and lung function before and after this medical procedure.

Patients with large pleural effusions often experience dramatic and immediate relief from dyspnea after therapeutic thoracentesis. Although this is a well-recognized phenomenon, the physiologic basis for such relief remains poorly understood. Primary physiologic basis for the relief in dyspnea after thoracentesis may include the improvement of the heart and lung function. In some cases the improvement in breathlessness cannot be attributed to the improvement of gas exchange, due to the atelectatic lung(not fully expansion of the lung). Transthoracic echocardiogram (TTE) is a non-invasive, real-time viewing of the internal parts of the heart using ultrasound, which can get highly accurate and quick assessment of the various heart images, though which doctors can quickly assess a patient's heart valves and degree of heart muscle contraction.

Eligibility Criteria:
Inclusion Criteria:

1. the estimated amount of effusion is above 500 ml;
2. Drainage was not performed within 1 month before admission;
3. assigned informed consent.

Exclusion Criteria:

1. physical weakness which is difficult to withstand the thoracentesis;
2. the happening of serious pleural reaction or reexpansion pulmonary edema on previous thoracentesis;
3. allergy to the anesthetic;
4. coagulation dysfunction, severe bleeding tendency;
5. serious mental illness who do not cooperate;
6. suspected with pleural hydatid disease;
7. skin infection around supine positioning;
8. severe heart function insufficiency who cannot lay on the back;
9. for a variety of reasons that cannot accept regular follow-up;
10. refused to sign the informed consent;
11. other conditions that is not suitable for the test.
Differential Diagnosis and Clinical Treatment Strategies of Thyroid Nodules.

To investigate the genetic mutations of patients with thyroid carcinoma and find molecular targets for therapy.

In previous studies, we have found highly prevalent TERT promoter mutations in aggressive thyroid cancers. So we plan to perform further research to investigate the genetic mutations of patients with thyroid carcinoma and find molecular targets for therapy.

Eligibility Criteria:
Inclusion Criteria:

* Patient with thyroid nodule

Exclusion Criteria:

* Coagulant function abnormality
* pregnant
Magnetic Seizure Therapy for Bipolar Mania

This trial attempts to evaluate the treatment efficacy of magnetic seizure therapy (MST) and its safety for bipolar mania. Half of the participants will receive MST, while the other half will receive electroconvulsive therapy (ECT).

Magnetic seizure therapy (MST) is likely to be an alternative options to electroconvulsive therapy (ECT).

Widespread stimulation of cortical and subcortical regions is inevitable for ECT since the substantial impedance of the scalp and skull shuts most of the electrical stimulus away from the brain. Nevertheless, magnetic pulses are capable to focus the stimulus to a specific area of the brain because they can pass the scalp and skull without resistance. In Addition, electric current will penetrate into deeper structures, while magnetic stimulus are only capable to reach a depth of a few centimeters. As a consequence, MST are able to generate focus stimuli on superficial regions of the cortex while ECT can't, which may give MST the capability to produce comparable therapeutic benefits with the absence of apparent cognitive side effects.

Eligibility Criteria:
Inclusion Criteria:

1. DSM-5 diagnosis of bipolar I disorder and currently in a manic episode;
2. convulsive therapy clinically indicated, such as severe psychomotor excitement or retardation, attempts of suicide, being highly aggressive, pharmacotherapy intolerance, and ineffectiveness of antipsychotics;
3. the Young Mania Rating Scale (YMRS) score ≥ 10;
4. informed consent in written form.

Exclusion Criteria:

1. primary diagnosis of other mental disorders;
2. severe physical diseases, such as stroke, heart failure, liver failure, neoplasm, and immune deficiency;
3. present with a laboratory abnormality that could impact on efficacy of treatments or safety of participants;
4. failure to respond to an adequate trial of ECT lifetime;
5. are pregnant or intend to get pregnant during the study;
6. Unremovable metal implants.
7. other conditions that investigators consider to be inappropriate to participate in this trial.
Effect of Medical Treatment on Longitudinal Function of the Heart

The purpose of this study is to determine the effect of medical treatment on longitudinal myocardial function. Patients who have been hospitalized for reasons other than heart disease will be examined with Transthoracic Cardiography before and after medical treatment to determine change in myocardial function.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patients receiving above-mentioned medications

Exclusion Criteria:

* Patients suffering from heart conditions
* Patients unable to undergo Echocardiography
* Pregnancy
Teacher Child Interaction Training (TCIT): Randomized Control Trial

This study is being conducted to evaluate the effects of TCIT on child development, child behavior, and teacher use of skills in the classroom.


Eligibility Criteria:
Inclusion Criteria:

* UMTCIT will target classrooms of children ages 1-5 enrolled in four participating B-2 Early Education Programs in Miami-Dade County: Debbie School, Easterseals South Florida, Arc of South Florida, and Linda Ray Intervention Center. Participants will also include school staff (teachers, teaching assistants, physical therapists, occupational therapists, speech/language pathologists) and students.

Exclusion Criteria:

* Children will be excluded from the study if they are 6 years of age or older or younger than 12 months of age at the start of each wave of treatment.