cyrilzakka/clinical-trials huggingface dataset:
Strategies in Patients Undergoing Repeat AF Ablation

The aim of the proposed research project is to compare the efficacy of three different ablation strategies in patients with atrial fibrillation (AF) who are undergoing their first repeat catheter ablation for recurrent AF.

Reconnection of the pulmonary veins (PV) is generally responsible for AF recurrence in most cases. However, in a growing subset of patients undergoing repeat ablation for recurrent AF, the PVs are chronically isolated and no other non-PV triggers of AF can be identified. The investigators have previously shown that empirically ablating at known common non-PV trigger sites for AF can improve arrhythmia free survival beyond PVI. The left atrial (LA) posterior wall is also increasingly being isolated in AF patients undergoing catheter ablation. However, long term arrhythmia free survival in AF patients undergoing LA posterior wall isolation is not consistently better than PVI alone.

The objective of this study therefore is to assess whether performing empiric ablation of common non-PV trigger sites or achieving LA posterior wall isolation can improve arrhythmia free survival in AF patients who are undergoing repeat AF ablation and in whom the PV remain chronically isolated and/or do not demonstrate AF. The investigators propose to do this as prospective, randomized three arm study.

Eligibility Criteria:
Inclusion Criteria: All patients undergoing first redo AF ablation who have chronically isolated pulmonary veins and no non-PV triggers with provocation testing (randomized intra-procedure).

Exclusion Criteria:

1. Patients in whom ≥1 PVs have reconnected and AF triggers can be elicited from the reconnected PV.
2. Patients who demonstrated non-PV triggers for AF.
3. Patients who have experienced arrhythmia recurrence post ablation where the recurrent arrhythmia is other than atrial fibrillation or typical atrial flutter
4. Failure to obtain informed consent
5. Patients with a mechanical mitral valve
Inebilizumab and Rituximab in Neuromyelitis Optica Spectrum Disorders

To compare the safety and efficacy of Inebilizumab and Rituximab in neuromyelitis optica spectrum disorders (NMOSD) patients.

Inebilizumab is a humanized anti-CD19 monoclonal antibody. CD19 is broadly expressed on B-lineage cells, particularly late-stage memory B-lymphocytes and plasma blasts. Inebilizumab depletes antibody-secreting plasmablasts and some plasma cells.

Rituximab (RTX) is a chimeric anti-CD20 monoclonal antibody that promotes B-lymphocyte depletion through antibody-dependent cellular cytotoxicity (ADCC)/complement-dependent cytotoxicity (CDC), promotes an immunoregulatory T-lymphocyte phenotype, and activates neutrophil/macrophage phagocytosis.

This is a retrospective, multicentre, real-world study which aims to compare Inebilizumab with RTX in neuromyelitis optica spectrum disorders patients. Eighty patients from 8 centres in China will be enrolled.

Eligibility Criteria:
Inclusion Criteria:

* 1. Age ≥ 18 years with anti-AQP4-IgG seropositive NMOSD as defined by 2015 NMOSD diagnostic criteria by IPND (International Panel for NMO Diagnosis).
* 2. Expanded disability status scale (EDSS) score ≤ 8 and ≥ 2.5 during the acute phase.
* 3. Patients have given their written informed consent.

Exclusion Criteria:

* 1. Lactating and pregnant females.
* 2. Participate in other interventional studies within 30 days or within 5 half-lives of the investigational agent before received inebilizumab and rituximab (RTX).
* 3. Receipt of any experimental B-cell depleting agent within 6 months prior inebilizumab and RTX, and B-cells below the lower limit of normal
* 4. Known history of a severe allergy or reaction to any component of the investigational product formulation.
* 5. Known active severe bacterial, viral, or other infection or any major episode of infection requiring hospitalization (including viral hepatitis, active tuberculosis or positive tuberculosis screening).
* 6. History of alcohol, drug, or chemical abuse, or a recent history of such abuse \< 1 year prior to treatment.
* 7. History of malignancies.
* 8. Combined with severe mental disorders and other conditions and unable to cooperate with follow-up.
Developing Brain Imaging Analysis Expertise for Personalizing Transcranial Electric Stimulation in Anhedonia Treatment of Patients with Bipolar Depression

The purpose of this study is to investigate whether transcranial direct-current stimulation (tDCS) will engage reward-related brain circuitry, more specifically the uncinate fasciculus (UF) tract, which connects the orbitofrontal cortex (OFC) and nucleus accumbens (NAcc) regions. Also to evaluate whether the changes in the fractional anisotropy (FA) of the UF tract are associated with changes of clinical symptoms of anhedonia and finally to investigate the moderation role of simulated electric fields (EFs) in an association between FA of the UF and symptoms of anhedonia.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of Bipolar Disorder and clinically significant anhedonia
* mild symptoms of depression

Exclusion Criteria:

* substance abuse/dependence and any use of drugs (except alcohol or nicotine) in the previous month of the baseline assessment
* participants with personality disorder that would interfere with study participation according to clinical judgment
* previous neurological conditions (epilepsy, traumatic brain injury, stroke, etc)
* any severe, life-threatening non-psychiatric medical condition
* specific contraindications for tDCS (metallic plates in the head)
* Participants identified as acutely suicidal or severely agitated
Tolerance of Healthy, Term Infants to Infant Formulas

To assess the gastrointestinal tolerance of healthy full-term infants fed either experimental formula or a control formula


Eligibility Criteria:
Inclusion Criteria:

* judged to be in good health.
* singleton from a full term birth with a gestational age of 37-42 weeks
* birth weight was \> 2490 g (\~5 lbs 8 oz)
* between 0 and 8 days of age at enrollment.
* Infant's parent(s) or a LAR has voluntarily signed and dated an ICF, approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) and provided Health Insurance Portability and Accountability Act (HIPAA) (or other applicable privacy regulation) authorization prior to any participation in the study.

Exclusion Criteria:

* An adverse maternal, fetal or infant medical history thought by the investigator to have potential for effects on tolerance, growth, and/or development, including, but not limited to suspected maternal substance abuse.
* Infant has been treated with antibiotics.
Effect of Interleukin 6 Receptor Antagonists in SARS-CoV-2 Patients

1. Investigate the possible effects of interleukin-6 receptor antagonists such as tocilizumab and sarilumab on the levels of IL-6, inflammtory and anti-inflammtory markers and cytokines before and after treatment in critically ill corona virus disease-19 patients.
2. Correlate between IL-6 levels with other inflammatory markers as ferritin and C-reactive protein.
3. investigate the possible changes on the levels of other inflammatory, anti-inflammatory markers and cytokines such as IL-10 and IP-10, before and after treatment.

An outbreak of a mutated respiratory virus that belongs to the Coronavirus family was reported in mid-December 2019, in Wuhan, China. The virus was named as severe acute respiratory syndrome coronavirus (SARS-CoV-2) and the disease was named as coronavirus disease-19 (COVID-19) by the WHO. The infection spread pandemically and by the end of October 2021,the number of confirmed cases of COVID-19 reached 244,897,472, including 4,970,435 deaths, reported by WHO. Viral genome was sequenced and published by public health information on 10th of January. COVID-19 uses the same cell entry receptor {Angiotensin converting enzyme II} (ACE2) as SARS-CoV . Recent studies have shown that IL-6 level increased in severe cases of COVID-19. IL-6 is one of the major pro-inflammatory factors that contribute to the formation of cytokine storm.Therefore, the IL-6 monoclonal antibody (mAb) directed COVID-19 therapy has been used in clinical trial in China. The main conclusion they reached was that the treatment with the IL-6 receptor antagonists ( tocilizumab (TCZ), sarilumab, sirukumab, olamkicept and levilimab) improved outcomes, including survival. TCZ is a humanized antibody that blocks both soluble and membrane-bound forms of IL-6 receptor. Sarilumab is a fully human antibody against the IL-6 receptor that binds to both soluble and membrane-bound IL-6 receptors and has the approval of the food and drug administration (FDA) for rheumatoid arthritis (RA) treatment. Additionally, these drugs have been considered for off-label use in the treatment of COVID-19.

Eligibility Criteria:
Inclusion Criteria:

* must be critically ill coronavirus disease-19

Exclusion Criteria:

* patients receiving corticosteroids
* pregnancy
* active TB
* bacterial infection
* fungal infection
* co-infection with other hepatitis viruses.
Oxidative Capacity and Exercise Tolerance in Ambulatory SMA

This proposal will focus on (1) estimating oxidative capacity of specific muscle groups during exercise using near infrared spectroscopy and (2) describing body composition to better understand exercise capacity and mitochondrial function in ambulatory spinal muscular atrophy (SMA) patients and disease controls. It is a 6-month observational study including 14 ambulatory SMA patients, 14 ambulatory patients with mitochondrial myopathy, and 14 healthy controls.

Spinal Muscular Atrophy (SMA) is a progressive, recessively-inherited neuromuscular disease characterized by weakness and muscle atrophy due to the loss of spinal cord motor neurons. The results from this study would provide preliminary data, using non-invasive methods, on oxidative capacity in ambulatory SMA patients and disease controls to aid in the design of exercise intervention studies. Furthermore, this information would link previous laboratory and preclinical findings of mitochondrial depletion in SMA to the clinical condition and provide important information for future studies designed to improve oxidative capacity and fitness in SMA patients.

Eligibility Criteria:
Inclusion Criteria:

1. One of the following categories:

   * Genetic confirmation of SMA with laboratory documentation of homozygous deletion of SMN1 exon 7;
   * Genetic confirmation of mitochondrial myopathy or evidence from muscle biopsy confirming the diagnosis; or
   * Healthy individuals.
2. Able to walk independently at least 25 meters, and able to tread a stationary cycle ergometer.

Exclusion Criteria:

1. Unable to walk 25 meters independently.
2. Use of investigational medications intended for the treatment of SMA within 30 days prior to study entry.
3. The presence of any contraindication to exercise according the ACSM criteria.

Patients with and without Spinraza treatment are eligible.
Study Of Perennial Allergic Rhinitis

This study was designed to assess safety of an investigational nasal spray in the treatment of perennial allergic rhinitis. Perennial allergic rhinitis is triggered by house dust, mite and mold etc. Typical symptoms are sneezing, nasal congestion and pruritus and rhinorrhea.


Eligibility Criteria:
Inclusion criteria:

* Informed consent.
* Outpatient.
* Diagnosis of perennial allergic rhinitis with symptoms.
* Able to comply with study procedures.

Exclusion criteria:

* Significant concomitant medical condition.
* Use of corticosteroids/allergy medications.
* Laboratory abnormality.
* Positive pregnancy test.
Gabapentin & Ketamine for Prevention/Treatment of Acute/Chronic Pain in Locally Advanced Head and Neck Cancer

This is a study to establish a safe and feasible dose for prophylactic use of a combination of gabapentin and ketamine in head and neck cancer patients undergoing chemoradiation.

Objectives:

* To establish the maximum tolerated dose of ketamine in combination with gabapentin up to a maximum planned dose of 40 mg three times a day.
* To evaluate feasibility and tolerability

Exploratory:

- To assess pain, symptom burden, functionality, and quality of life

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven cancer of the head and neck cancer
* Locally advanced non-metastatic disease (T3N0M0, T4N0M0, T1-4N1-3M0)
* Planned primary or adjuvant radiation or chemoradiation therapy
* Willing and able to provide informed consent
* ECOG PS 0-2
* Age ≥ 21 years
* English speaking

Exclusion Criteria:

* Currently on gabapentin or ketamine
* Prior non-tolerance of gabapentin or ketamine
* Unable to administer ketamine intranasally due to anatomical restrictions
* History of seizure disorder
* History of schizophrenia
* History of increased intracranial pressure
* Glomerular filtration rate \<30 mL/min/1.73 m2
Efficiency of Favourite Versus Predetermined Musical Sequence on Gynecology Pre-operative Anxiety

Anxiety is a psychologic and physiological state that could be characterized by somatic, emotional, cognitive and behavioral components. Surgery, as well as waiting for surgery is an anxiogenic situation encountered by 60 à 80 % of the patients. High levels of anxiety lead to negative physiological signs that slow down healing, lowers imune response and increases post-surgery infection. Anxiety also increases pain and post-surgery morbi-mortality. Drug-induced sedation is frequently recommended to lower anxiety. The anxiolytic effect of alternative treatment such as musicotherapy has been demonstrated in several randomized control trials. Nevertheless, most of these studies have investigated the effect of musicotherapy in groups with our without musical listening.

In the present study, investigators assume that a personal musical sequence composed by favourite songs of the patients could have beneficial effect on presurgical anxiety than selective sequence of the medical device MUSIC CARE.

In this study, the anxiolytic effect of predefined U musical sequences that alternate slow and faster music tracks (medical device MUSIC CARE) are compared to patient's play-list, in women with planned gynecological surgery.

Patients are randomly allocated in two groups:

* control group: patients are asked to choose one of the U sequence among the preselected music style proposed by the medical device MUSIC CARE
* test group: patients are asked to prepare their own play-list containing their favourite songs

Anxiety is assessed before and after a 20 min-musicotherapy session by using the State-Trait Anxiety Inventory (STAI) for anxiogenic situation.

Other parameters are measured such as blood pressure, cardiac frequency, level of pain after surgery, care stay duration, potent post-surgery complications.

Eligibility Criteria:
Inclusion Criteria:

* with planed gynecologic surgery
* without anxiolytic medication
* able to prepare their own play-list
* signed inform consent

Exclusion Criteria:

* hearing disorder
* dementia or psychiatric disorder
* neurologic disorder
Toxicity Substudy of Evaluation of Subcutaneous Proleukin in a Randomised International Trial (ESPRIT): TOXIL-2 Substudy

This substudy is an open-label, randomised study comparing the uptake of recombinant interleukin-2 (rIL-2) in HIV-1 infected individuals receiving different combinations of antiemetics and analgesic agents during rIL-2 dosing in ESPRIT. The design is a factorial one with 4 arms. All patients will receive regular ibuprofen and paracetamol from days 1-6 of the rIL-2 dosing cycle; in addition, patients will be randomised to receive one of two antiemetic combinations, i.e. ondansetron or metoclopramide with or without low dose codeine phosphate as an additional analgesic agent.

The research is a randomised open-label substudy of ESPRIT. The substudy is exploring whether the amount of rIL-2 taken during a dosing cycle of rIL-2 can be increased through controlling the predictable side-effects of rIL-2 better. This is a four arm study with a factorial design; patients will be randomised to one of four arms. Each arm consists of different combinations of adjunctive agents. Each patient will receive paracetamol and ibuprofen prophylactically throughout the cycle, the other adjunctive agents prescribed will vary according to which arm the patient is randomised to, but the antiemetic used will be either ondansetron or metoclopramide with or without low dose codeine phosphate as an additional analgesic agent. The primary end-point is the percentage of planned rIL-2 actually taken during the cycle. Secondary end-points include safety, side-effects of rIL-2 and the adjunctive agents, CD4+ T-cell changes and quality of life measures.

Eligibility Criteria:
Inclusion Criteria:

Patients participating in ESPRIT and randomised to the rIL-2 arm, who:

1. Are not at CD4+ T-cell target for the protocol
2. Have not received rIL-2 for \> 2 months
3. Have reported both GI upset and constitutional side-effects as one of the reasons for either dose modifying in prior cycles or unwillingness to receive further rIL-2
4. Are considered by the Investigator as medically safe to receive further dosing with rIL-2
5. Are willing to receive further dosing with rIL-2 at the dose specified by the Investigator
6. Are willing to sign informed consent to participate in the substudy

Exclusion Criteria:

1. All exclusions for the receipt of rIL-2 on ESPRIT
2. Known allergy to non-steroidal anti-inflammatory drugs (NSAIDs), opiates, 5HT-3 (serotonin-3) inhibitors, anti-dopaminergic antiemetics, or any other components of the proposed adjunct regimens.
3. Use of other NSAIDs (cyclooxygenase-2 \[COX-2\] inhibitors, corticosteroids) or opiate analgesics within two weeks of rIL-2 dosing. Use of low dose aspirin as a cardio-protective agent is allowed.
Cervical Dizziness in Patients With Acute Non-specific Neck Pain

Acute non-specific neck pain (ANSNP) is one of the causes of cervicogenic dizziness (CD).To investigate the severity of CD in patients with ANSNP and to determine the efficacy of the treatment and follow-up.

The primary aim of this study was to investigate the contribution of cervical proprioception impairment to the development of cervical dızzıness in patients with acute non specific neck pain and to determine the efficacy of the treatment and follow-up performed in patients coexisting with cervical dizziness and nonspecific neck pain. Our hypothesis was that the objective measurement of muscle stiffness with shear-wave elastography could aid in the differential diagnosis in patients coexisting with cervical dizziness and non specific neck pain.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria were as follows: pain on palpation in the neck area, neck stiffness, tension and tenderness in the neck muscles, and cervical movement limitation. All the patients included in the study had no history of a maneuver for dizziness, no history of ototoxic drug use, and had normal hearing.

Exclusion Criteria:

* Exclusion criteria included presence of benign paroxysmal positional vertigo (BPPV), Meniere's disease, migraine-associated vertigo, vertebrobasilar insufficiency, postural hypotension, a history of trauma to the cervical region, myofascial pain syndrome, and neurological, rheumatological, and systemic diseases. Additionally, patients detected with neck-related conditions (cervical spondylosis, cervical disc hernia, fracture, dislocation, spondylolisthesis, scoliosis) and fibromyalgia in cervical magnetic resonance imaging (MRI) were also excluded from the study.
A Study of Microbiome Transplantation for the Treatment of Constipation in Patients with Systemic Sclerosis

The purpose of this study is to evaluate the tolerability and safety of frozen and lyophilized microbiome transplant product (PRIM- DJ2727), to characterize the microbiome (α-diversity and β-diversity) and metabolome in patients with Systemic Sclerosis (SSc)related constipation, to examine improvement in constipation after microbiome transplant by comparing post-treatment with pre- treatment fecal samples and patient-reported outcome measures, to examine improved colonic transit after microbiome transplant , to examine subjective global improvement and improvement in SSc disease characteristics, to monitor change for change in concentration in systemic and fecal inflammatory markers to monitor for change in fecal short-chain fatty acids and metabolome and to provide data that will be used to determine the appropriateness of designing a properly powered clinical trial of microbial restoration treatment in the SSc population


Eligibility Criteria:
Inclusion Criteria:

* Are seen in the UT Houston Scleroderma Center (UTHSC)
* Meet 2013 American college of rheumatology (ACR)/European league against rheumatism (EULAR) criteria or CREST criteria for SSc
* Meet Rome IV criteria for constipation
* Subject willing to sign an informed consent form
* Subject deemed likely to survive for ≥ 1 year after enrollment
* Able to follow study procedure and follow-up
* Sexually active male and female subjects of childbearing potential must agree to use an effective method of birth control during the treatment and follow-up period
* Female subjects of childbearing potential must have a negative pregnancy test in the 72 hours before the procedure
* Subjects who agree to adhere to a stable diet during the study
* Subjects must have an attending physician who will provide non-transplant care for the subject

Exclusion Criteria:

* Subjects with constipation from causes not attributed to SSc as determined by the treating physician (e.g., inflammatory bowel disease, medication, significant diabetes or hypothyroidism, etc.)
* Subjects unwilling to stop taking probiotic supplements during the duration of the study
* Subjects who have diarrhea defined as loose, watery stools three or more times a day
* Subjects that have post-total or hemicolectomy or the presence of a colostomy
* Subjects unable to (a) tolerate microbiome transplant via enema for any reason or (b) swallow capsules
* Subjects requiring systemic antibiotic therapy 4 weeks before the study
* If subjects are on immunosuppression, the immunosuppression dose should be stable for at least 4 weeks before study enrollment