cyrilzakka/clinical-trials huggingface dataset:
Task Practice and Spinal Cord Stimulation

The goal of this study is to understand the effects of combined task practice with transcutaneous cervical spinal cord stimulation. The study will explore the effect of higher stimulation frequencies on spasticity. Transcutaneous stimulation has been shown to improve motor function in some individuals with chronic spinal cord injury. The study intends to explore scientifically the association between higher stimulation frequencies and spasticity/hypertonicity.


Eligibility Criteria:
Inclusion Criteria:

* 22-70 years of age
* Non-progressive cervical spinal cord injury
* Minimum 12 months year post-injury.
* American Spinal Injury Association (ASIA) Impairment Scale (AIS) classification B, C, or D.
* Able to take part in upper extremity therapy procedures.
* GRASSP-Prehension score ≥10.
* MAS Score ≥3 but \<6 in at least one arm.
* Can commit to the time required for the study.
* Stable medication profile for at least 4 weeks prior to enrollment.
* Able to reduce Baclofen dose to 30 mg or less daily.
* Capable of providing informed consent.

Exclusion Criteria:

* Has any unstable or significant medical condition that is likely to interfere with study procedures like severe neuropathic pain, depression, mood disorders, or other cognitive disorders.
* Has uncontrolled cardiopulmonary disease or cardiac symptoms.
* Requires ventilator support.
* Has been diagnosed with autonomic dysreflexia that is severe, unstable, and uncontrolled.
* Has an autoimmune etiology of spinal cord dysfunction/injury
* Previously diagnosed as having transverse myelitis
* History of additional neurologic diseases such as stroke, multiple sclerosis, traumatic brain injury, epilepsy or history of seizures.
* Peripheral neuropathy (diabetic polyneuropathy, entrapment neuropathy, etc.)
* Uncontrolled spasms, which have been unstable over the past three months prior to enrollment and are not expected to change.
* Received Botulinum toxin injections in their upper extremity, neck, or hand within six months prior to enrollment.
* Has painful musculoskeletal dysfunction, unhealed fracture, contracture, pressure sore, or urinary tract infection at the time of enrollment.
* Breakdown in skin area that will come into contact with electrodes.
* Presence of syringomyelia as determined by an MRI.
* Currently undergoing treatment for cancer or has been in remission for less than 2 years.
* Received stem cell treatment within the past two years prior to enrollment.
* Has any active implanted medical device.
* Concurrent participation in another drug or device trial that may interfere with this study.
* In the opinion of the investigators, the study is not safe or appropriate for the participant.
* Persons who are unable to consent, pregnant women, and prisoners.
Femoral Vein Hemostasis After Ablation for Atrial Fibrillation With Manual Pressure Versus a Figure of 8 Suture

Patients who undergo ablation for AF typically have 2 sheaths placed in each groin, including a large sheath when the Cryo Balloon is used for pulmonary vein isolation. During the procedure, heparin is administered to maintain a target ACT \> 300 seconds. At the conclusion of the procedure, the venous sheaths are removed and hemostasis is obtained. There are at least 2 ways of obtaining hemostasis after venous access. In the manual hemostasis approach, an ACT is checked and protamine is administered. The ACT is rechecked 20" later, and if \< 220 msec, the sheaths are pulled and hemostasis is achieved with manual pressure (Manual Hemostasis Group). Another approach is to place a Figure of 8 suture around the sheaths in each groin to achieve hemostasis as the sheaths are removed, and therefore obviate the need for assessment of the ACT, protamine administration, and manual pressure (Figure of 8 Group).


Eligibility Criteria:
Inclusion Criteria:

* Any patient who meets standard clinical criteria for an ablation of AF with Cryoballoon, and is to undergo the procedure

Exclusion Criteria:

1. Pregnant patients.
2. Age \<18 years.
3. Patients who cannot provide consent in English.
4. Prisoners.
Latanoprost Plus NB-UVB Versus Each Alone in Non-segmental Vitiligo: Clinical and Laboratory Evaluation

The aim of the study is to evaluate the efficacy of different lines of therapies on the TWEAK serum level in patients with non-segmental vitiligo.

the study is to evaluate the efficacy of NB-UVB, latanoprost, and combination of them on the TWEAK serum level in patients with non-segmental vitiligo.

Eligibility Criteria:
Inclusion Criteria:

* Patients with non-segmental vitiligo of any age and gender.

Exclusion Criteria:

* History of vitiligo treatment with topical, systemic or biological agents prior to the study for at least 3 weeks.
* Pregnancy and lactation.
* Infections
* Patients with other autoimmune diseases.
* Patients with chronic diseases: cardiac diseases, hepatic disorders, hematologic disease, chronic renal failure or malignancies.
Optimal Strategy for Repair of Type A Acute Aortic Dissection

Acute type A aortic dissection (TAAD) persists as a clinicopathologic entity with high lethality in the current era. Several procedures are presently used to repair the TAAAD. The objective of this study is to analyze two groups of individuals using a conservative approach through root-sparing and hemiarch techniques in patients who are hospitalized in higher-risk clinical conditions or more aggressive procedures such as root replacement and total arch replacement in low-risk patients.

The target population enrolled in the registry includes patients with TAAAD.The high volume of patients that will be enrolled in this registry will receive proximal and distal aortic repair in elective, urgent or emergency clinical condition. Efforts of investigators will be concentrated in TAAAD repair using a conservative approach of root preservation and hemiarch reconstruction in the majority of patients who will be referred in critical clinical condition. High-risk patients with older age or more comorbidities had more conservative repairs to limit surgical insult to these complicated patients. Total arch reconstruction and root replacement will be optional procedures for specific subgroups of patients who may benefit from a more complex index finger operation without incurring additional immediate risk.

Investigators hope to demonstrate a reduction in operative mortality and an improvement in early and late outcomes. The experience of investigators will be summarized in an algorithm for TAAAD repair with an analysis of early morbidity and mortality, as well as late survival and no reoperation.

Eligibility Criteria:
Inclusion Criteria:

* TAAD or intramural hematoma involving the ascending aorta
* Patients aged \> 18 years
* Symptoms started within 7 days from surgery
* Primary surgical repair of acute TAAD
* Any other major cardiac surgical procedure concomitant with surgery for TAAD.

Exclusion Criteria:

* Patients aged \< 18 years
* Onset of symptoms \> 7 days from surgery
* Prior procedure for TAAD
* Concomitant endocarditis;
* TAAD secondary to blunt or penetrating chest trauma.
Observational Studies of the Application of Bevacizumab in HER2-negative Breast Cancer Neoadjuvant Chemotherapy

- The purpose of this study is to evaluate the efficacy and safety of the application of bevacizumab combined neoadjuvant chemotherapy in HER2-negative breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* HER2-negative breast cancer patients
* Without surgery
* Plans to neoadjuvant chemotherapy

Exclusion Criteria:

* HER2-positive breast cancer patients
* Post-operative patients
Turkish Version of Telephone Based ABILOCO-Stroke

The aims of this study were to perform cultural adaptation of the telephone based ABILOCO-stroke instrument and provide information regarding the factor structure, reliability and validity of the instrument in Turkish speaking patients with stroke.


Eligibility Criteria:
Inclusion Criteria:

* hemiparetic individuals who were ≥ 18 years of age
* were at least 4 weeks after the onset of the stroke
* able to walk with or without assistive devices.

Exclusion Criteria:

* cognitive impairments
* aphasia
* any other non-stroke-related conditions.
Study to Determine the Efficacy and Safety of Docetaxel and Doxorubicin With INGN 201 in Locally Advanced Breast Cancer

A maximum of 60 subjects will be enrolled in the trial. It is a non-randomized, open label, single center study. All subjects undergo INGN 201 injection and IV chemotherapy: doxorubicin and docetaxel. This is done on the first 2 days of a 3-week cycle. After completion of 4 to 6 cycles, the subject either proceeds to surgery if the tumors respond to therapy, or goes off study if there is no tumor response.


Eligibility Criteria:
Documented late stage breast cancer: stage III A-B (excluding inflammatory breast carcinoma) or localized stage IV breast cancer

Male or female

18 years or older

Adequate bone marrow, liver, and kidney function
Effects Of Lapatinib (GW572016) In Patients With Relapsed Adenocarcinoma Of The Esophagus

This Phase II study will assess the efficacy, safety, and pharmacodynamics and pharmacokinetics of 1000 mg and 1500 mg lapatinib administered once daily in patients with relapsed adenocarcinoma of the esophagus, including tumors of the GE junction and gastric cardia.


Eligibility Criteria:
Inclusion criteria:

* Has a histologically confirmed adenocarcinoma of the esophagus.
* GE (gastroesophageal) junction or gastric cardia.
* Must be of non-child-bearing potential or is of child-bearing potential.
* Have a negative serum pregnancy test and agree to an approved form of birth control.
* Have an ECOG (Eastern Cooperative Oncology Group) Performance status less than or equal to 2.
* Have a life expectancy of at least 12 weeks.
* Have provided written informed consent.
* Investigator considers patient to be fit for study from lab test results and interview.

Exclusion criteria:

* Pregnant or lactating female.
* Prior resection of the small bowel.
* Received major surgery.
* Received prior radiation therapy to the mediastinum or abdomen.
* Has a known immediate or delayed hypersensitivity reaction.
* Idiosyncrasy to drugs chemically related to the study drug.
Safety and Efficacy of AT-527 in Subjects With Moderate Coronavirus Disease (COVID-19) in a Hospital Setting

The objectives of this study are to evaluate the safety, tolerability, antiviral activity and efficacy of AT-527 in adult subjects ≥18 years of age with moderate COVID-19 and risk factors for poor outcomes (such as obesity (BMI\>30), hypertension, diabetes or asthma). Eligible subjects will be randomized to blinded AT-527 (nucleotide analog) tablets or matching placebo tablets to be administered orally for 5 days. Part A will evaluate an AT-527 dose of 550 mg BID and Part B will evaluate a second dose of AT-527 (1100 mg BID). Local supportive standard of care (SOC) will be allowed for all subjects. Efficacy, antiviral activity and safety observations will be compared for treatment with active AT-527 tablets vs. placebo tablets.


Eligibility Criteria:
Key Inclusion Criteria:

* Hospitalized or in a hospital-affiliated confinement facility
* SARS-CoV-2 positive
* Initial COVID-19 symptom onset within 5 days prior to Screening
* SpO2 ≥ 93% on room air or requires ≤ 2L/min oxygen by nasal cannula or mask to maintain SpO2 ≥ 93%
* Must also have a history of at least one of the following known risk factors for poor outcomes: obesity (BMI\>30), hypertension, diabetes or asthma.

Key Exclusion Criteria:

* Severe or critical COVID-19 illness: RR ≥30, HR ≥125, SpO2 \<93% on room air or requires \>2L/min oxygen by nasal cannula or mask to maintain SpO2 ≥93%, systolic blood pressure \< 90 mm Hg, diastolic blood pressure \< 60 mm Hg or PaO2/FiO2 \<300
* Requires mechanical ventilation
* Lobar or segmental consolidation on chest imaging.
* Treatment with other drugs thought to possibly have activity against SARS-CoV-2
* ALT or AST \> 5 x upper limit of normal (ULN)
* Female subject is pregnant or breastfeeding
* Has received or is expected to receive any dose of a SARS-CoV-2 vaccine before the Day 14 visit (Part B).
A Study to Evaluate the Efficacy and Safety of Two Dose Strengths of Dalfampridine Extended Release Tablets.

The objective of this study is to determine the effect of two dose strengths of dalfampridine-Extended Release (ER) tablets, taken twice daily for 12 weeks, on stable walking deficits in subjects with post-ischemic stroke.

This was a randomized, placebo-controlled, three-arm, parallel-group study designed to evaluate the efficacy, safety, and tolerability of dalfampridine extended release (ER) tablets on chronic walking deficits in subjects with post-ischemic stroke.

Eligibility Criteria:
Inclusion Criteria:

* Clinical evidence of a stable walking deficit due to an ischemic stroke, as judged by the Investigator, based on review of medical records and physical exam. Such deficit was not present prior to the stroke and cannot be attributed primarily to other conditions (e.g. chronic obstructive pulmonary disease, arthritis). Evidence of walking deficits is objectively supported by any one of the following findings on clinical examination:

  1. obvious slowness of movement assigned primarily to the stroke
  2. use of an assistive walking device such as a cane or walker
  3. Presence of movement pattern deviations such as stiff-legged gait, foot drop, hip hiking and hip circumduction
* Modified Rankin Scale score of 1 - 3, regardless of the cause(s) of the disability
* Sufficient ambulatory ability to independently complete the 2MinWT and 10MWT
* ≥ 6 months from occurrence of most recent stroke

Exclusion Criteria:

* Woman who is not surgically sterile or is less than 2 years postmenopausal, and does not agree to use a highly effective birth control method during the study and up to 3 months after the last dose of investigational product.
* Woman who is pregnant, breastfeeding, or planning to become pregnant
* History of seizures, except simple febrile seizures
* Moderate or severe renal impairment as defined by a calculated creatinine clearance of ≤ 50 mL/minute using the Cockcroft-Gault Equation
* Suicide attempt within 1 year prior to the Screening Visit, or severe suicidal ideation within 6 months prior to the Screening Visit, or subject is at significant risk of suicidal behavior in the opinion of the Investigator
* Previous use of AMPYRA, dalfampridine, fampridine or 4-aminopyridine (4-AP)
* Initiation of a serotonin reuptake inhibitor (SSRI) within 3 months prior to the Screening Visit, or any change in dosing regimen within 3 months prior to the Screening Visit
* Botulinum toxin use within 2 months prior to the Screening Visit
* Orthopedic surgical procedures in any of the extremities within the past 6 months
The Effect of Mouth Closure on Airflow in OSA

Mouth breathing is associated with increased airway resistance, pharyngeal collapsibility, and obstructive sleep apnea (OSA) severity. It is commonly believed that closing the mouth can mitigate the negative effects of mouth breathing during sleep. However, we propose that mouth breathing serves as an essential route bypassing obstruction along the nasal route (e.g., velopharynx). The present study investigates the role of mouth breathing as an essential route in some OSA patients and its association with upper airway anatomical factors.

Participants underwent drug-induced sleep endoscopy (DISE) with simultaneous pneumotach airflow measurements through the nose and mouth separately. During the DISE procedure, alternating mouth closure (every other breath) cycles were performed during flow-limited breathing.

We evaluated the overall effect mouth closure on inspiratory airflow, and the change in inspiratory airflow with mouth closure across three mouth-breathing quantiles. We also evaluated if velopharyngeal obstruction was associated with mouth breathing and a negative airflow response to mouth closure.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed obstructive sleep apnea (AHI \> 5 events/h).
* Scheduled to undergo clinical drug-induced sleep endoscopy.

Exclusion Criteria:

* pregnancy
* age under 18 years
* poor general health
* allergy to propofol or dexmedetomidine
* history of surgical treatment for sleep apnea, such as palate, tongue base, or epiglottis surgery.
A Waiting Room-Delivered Video to Enhance Clinical Outcomes Among Persons Living With HIV

The purpose of this project is to beta-test a brief waiting room video intervention that promotes early initiation of antiretroviral treatment among treatment-naïve HIV-positive patients, adherence to antiretroviral treatment and retention in care among HIV-positive patients currently on therapy, sexual risk reduction tailored to HIV-positive persons, and patient-initiated discussion of these topics with their health providers. The video is currently being created, and will be ready for beta-testing by June 1, 2016. Results of the beta-testing will be used to refine and improve the video before dissemination to HIV/AIDS treatment facilities nationally. This video project is being funded by the Centers for Disease Control and Prevention, Division of HIV/AIDS Prevention (DHAP).

The overall goal of this study is to beta-test the waiting room video in three HIV/AIDS treatment facilities in different US jurisdictions with high AIDS prevalence. These results will be used to refine the video and to increase its effectiveness among minority persons living with HIV infection. The beta-testing will consist of: 1) unobtrusive observations of waiting room patients for one day at each facility and 2) de-identified, existing patient medical data abstracted from each facility's electronic medical record (EMR) system to investigate outcomes relevant to HIV medication adherence and retention in care.

Eligibility Criteria:
Inclusion Criteria:

HIV/AIDS treatment facility inclusion: The participating treatment facilities will have a combined total of at least 2,700 monthly patient visits during the study period. Each of the HIV/AIDS treatment facilities meets the following inclusion criteria:

1. located in a jurisdiction with high AIDS prevalence;
2. managing more than 500 unique HIV-positive patients annually;
3. serving minority persons such that minimally 55% of the clinic population is African-American and Hispanic/Latino;
4. at least 163 patients have unsuppressed viral load;
5. utilizing an electronic medical record (EMR) system; and
6. not participating in another behavioral intervention research project during the historical comparison data period (August 2015 through May 2016) or during the 10-month intervention period (June 2016 through March 2017).

Exclusion Criteria:

-
Randomized Phase II Study of DCE-MRI-based Dose Escalation for Poor-prognosis and Neck Cancer

This study aims to improve locoregional control of poor prognosis Head and Neck Cancer (HNC) patients by selectively escalating the radiotherapy dose to subvolumes of tumor likely to be resistant to standard Radiation Therapy (RT) using DCE-MRI (Dynamic Contrast Enhanced Magnetic Resonance Imaging). Standard doses of radiotherapy to the rest of the tissues and surrounding normal tissues will be maintained.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have pathologically-confirmed, non-metastatic locally/regionally advanced squamous cell carcinoma of the head and neck, stage III/IV, referred for definitive chemo-RT, and meet one of the following six criteria:

  1. Primary tumor (T4) with or without metastatic lymph nodes. Tumor or nodes are: unresectable, resection is considered by the treating surgeon or patient to result in unacceptable functional or oncological results, patient refuses surgery, or surgery is not possible due to comorbidities.
  2. HPV(-) (Human Papillomavirus) or p16(-) locally/regionally advanced (T3-4 or N2-3) oropharyngeal cancer.
  3. HPV(+) or p16(+) locally/regionally advanced (T4 or N3) oropharyngeal cancer.
  4. T3 or T4 laryngeal or hypopharyngeal cancer that is locally advanced, bulky (\>40 cc\*), unresectable, or patient declines surgery.
  5. Stage III/IV oral cavity or paranasal sinus cancers in patients who refuse surgery or are unfit for surgery.
  6. Locally/regionally advanced (stage T3-4 and/or N3) nasopharyngeal cancer which is EBV (-) (Epstein-Barr Virus).
* KPS (Karnofsky Performance Status: A measure of general well being and activities of daily living; scores range from 0 to 100 where 100 represents perfect health) \>70 (see Appendix A) within two weeks of enrollment.
* Pre-treatment laboratory criteria within four weeks of enrollment:

  * WBC (White Blood Cell) \> 3500/ul, granulocyte \> 1500/ul.
  * Platelet count \> 100,000/ul.
  * Total Bilirubin \< 1.5 X ULN.
  * AST (Aspartate Aminotransferase) and ALT (Alanine Aminotransferase) \< 2.5 X ULN.
  * Estimated Creatinine clearance \>30cc/min.
* Patients must be able to receive protocol chemotherapy in the judgment of the treating Medical Oncologist.
* Patients are adults (Age ≥18).
* All patients must be informed of the investigational nature of this study and given written informed consent in accordance with institutional and federal guidelines.

Exclusion Criteria:

* EBV (+) Nasopharyngeal Carcinoma in the protocol treated tumor.
* Prior head and neck radiation.
* Documented evidence of distant metastases.
* Patients with active infection.
* Pregnant women.
* Patients should have no contraindications to having a contrast enhanced MRI scan. These contraindications will be assessed at the time of enrollment using the guidelines set up and in clinical use by the Institutional Standard Practice.
Comparison of Effectiveness of Pentobarbital and Thiopental in Patients With Refractory Intracranial Hypertension

Objective: to assess the effectiveness of pentobarbital and thiopental to control raised intracranial pressure (ICP), refractory to first level measures, in patients with severe traumatic brain injury.

Material and methods: prospective, randomized open study to compare the effectiveness between two treatments: pentobarbital and thiopental. The patients will be selected from those admitted to the Intensive Care Unit with a severe traumatic brain injury (postresuscitation Glasgow Coma Scale equal or less than 8 points) and raised ICP (ICP\>20 mmHg) refractory to first level measures according to the Brain Trauma Foundation guidelines. The adverse effects of both treatments were also collected.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a severe closed head injury and a post-resuscitation Glasgow Coma Scale (GCS) score below or equal to 8
* Age between 15 and 76 years (inclusive)
* High ICP (\> 20 mm Hg) refractory to first-tier therapeutic measures according to BTF guidelines (1)
* Hemodynamic stability defined as a systolic blood pressure of at least 100 mm Hg or above at the moment of entering the trial
* Written informed consent obtained from next-of-kin or the patient's legally authorized representative

Exclusion Criteria:

* Previously known ischemic heart failure (Ejection fraction \< 35%)
* Pregnancy
* bilateral dilated and unreactive pupils and a GCS of 3
* Intolerance to barbiturates