cyrilzakka/clinical-trials huggingface dataset:
Expanded Access Remdesivir (RDV; GS-5734™)

Disease caused by 2019 Novel Coronavirus also known as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)

The treatment of communicable Novel Coronavirus (CODIV-19) of 2019 with Remdesivir (RDV; GS-5734™) also known as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)

Eligibility Criteria:
Inclusion Criteria:

* DoD-affiliated personnel as defined in DoDI 6200.02, which includes emergency-essential civilian employees and/or contractor personnel accompanying the Armed Forces who are subject to the same health risk as military personnel
* Have a laboratory-confirmed COVID-19 diagnosis with moderate to severe disease presentation as determined by the principal investigator
* Patient or legally authorized representative (LAR) provides written informed consent, except as noted in 21 CFR 50.23
* Understands and agrees to comply with planned study procedures
* Available for clinical follow-up for duration of the treatment and follow-up period
* Woman of childbearing potential must

  * Have a negative pregnancy test within 24 hours before starting treatment
  * Agree not to become pregnant during treatment and for 1 months after receiving remdesivir (Treatment will be a maximum of 10 doses given over a 10-day interval)
  * Use at least 2 reliable forms of effective contraception, including 1 barrier method, during treatment and for 1 month after the treatment period

Exclusion Criteria:

* ALT/AST ≥ 5 times the upper limit of normal
* Stage 4 severe kidney disease or requiring dialysis (i.e. eGFR \<30)
* Anticipated transfer to another hospital that is not a study site within 72 hours
* Allergy to any components of the study medication \[GS-5734, sulfobutylether β-cyclodextrin sodium (SBECD) and hydrochloric acid and/or sodium hydroxide\]
* Concomitant antiviral therapy (lopinavir/ritonavir \[Kaletra\])
* Pregnant or nursing
Vibrotactile Feedback Belt in Patients With Unilateral Vestibular Hypofunction (UVH)

The goal of this clinical trial is to study the impact of a continuous vibrotactile feedback belt on balance, (fear of) falling, fatigue and overall functioning in participants with chronic disabling unilateral vestibular hypofunction.

The main questions it aims to answer are: • does wearing a vibrotactile feedback belt during waking hours for a week improve sense of balance and mobility, fear of falling, fatigue and overall functioning • does wearing a vibrotactile feedback belt influence static and dynamic balance and gait performance during balance and gait testing.

Participants will goes through different phases in an randomized order; a baseline phase, a sham phase (i.e., wearing the BalanceBelt while it is switched off) and an intervention phase (i.e., wearing the BalanceBelt while it is switched on).

It is expected that, just as with patients with bilateral loss of the balance organ, patients with a unilateral loss will also benefit from the BalanceBelt.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with severe unilateral vestibular dysfunction (i.e., a gain below 0.6 of the affected side and a gain between 0.8 and 1.1 of the contralateral side measured by the video-Head Impulse Test (vHIIT)).
* Duration of dizziness complaints \>3 months (i.e. chronic dizziness).
* Self-reported imbalance with a fear of falling and/or actual falls.
* Is able to walk (with or without a walking aid).
* Self-reported overall Mobility and Balance Score (MBS) of 3-5 points
* Motivated to try the BalanceBelt.
* Provides written informed consent.

Exclusion Criteria:

* Age \< 18 years
* Presence of neurological, psychiatric or orthopaedic disorders, Persistent postural-perceptual dizziness (PPPD), reduced proprioceptive sensitivity or impaired vision which influences the postural stability.
* Not able to understand instructions and questionnaires in Dutch
* Not able/willing to visit Gelre Hospital Apeldoorn for necessary visits.
* Wheelchair bound at home
A Trial Comparing Adductor Canal Catheter and Intraarticular Catheter Following Primary Total Knee Arthroplasty

The study is a prospective randomized controlled trial comparing intraarticular catheters and adductor canal catheters for postoperative analgesia following a primary Total Knee Arthroplasty (TKA).

The study is a prospective, randomized controlled clinical trial comparing two methods of postoperative analgesia following primary TKA. Eligible primary TKA patients must be ASA I - III and require less than 20 mg oxycodone daily (or its equivalent). Exclusion criteria are: allergy to anesthetics, contraindication to regional anesthesia, sensory/motor disorder involving operative limb, non-english speaking, ASA IV or greater, psychiatric or cognitive disorders, incarceration, renal insufficiency with Cr \> 2.0 and hepatic failure. When patients agree to participate in the study the following data will be collected by the research staff: ASA physical status, age, height, weight, gender, quantitative opiate use, numeric pain score with visual descriptors, painDETECT score (form included), WOMAC score (form included) and baseline Pain Management Questionnaire. When designated through randomization, intra-articular catheters will be placed intraoperatively by the surgeons, per usual protocol. ACC's will be placed postoperatively in the PACU. The catheters will exit the bandage in a similar fashion to blind the personnel collecting data, postoperatively. Those collecting data will not be blinded from identifying patients in the control group, as no catheter will exit the bandage. Potential risks for each procedure, which will be explained to the patient, include: bleeding, local infection, local anesthetic toxicity in the form of seizure and cardiac arrest and neuropathy. The preceding are commonly listed though infrequent complications of both procedures. Continuous ultrasound will guide the placement of the ACC.

Eligibility Criteria:
Inclusion Criteria:

* Age 40-85
* American Society of Anesthesiologists (ASA) Physical Status (PS) 1-3.
* Undergoing Unilateral, Primary, Total Knee Arthroplasty
* English as native language

Exclusion Criteria:

* Patient refusal
* History of opioid dependence
* Contraindication to peripheral nerve block
* Pre-existing significant neuropathy
Stellate Ganglion Block for Hot Flushes in Men Treated With ADT

Androgen deprivation therapy (ADT) is widely used as standard therapy in the treatment of locally advanced and metastatic prostate cancer. Hot flushes and night sweats are one of the main side-effects of ADT. There are no successful and well-tolerable treatment options available. A possible treatment for hot flushes is stellate-ganglion block (SGB), used as a means of interrupting parts of the sympathetic nervous system involved in temperature regulation.

Objective of this study:

To assess the short-term efficacy of stellate ganglion block on hot flush reduction versus sham procedure

Androgen deprivation therapy (ADT) is widely used as standard therapy in the treatment of locally advanced and metastatic prostate cancer. Hot flushes and night sweats are one of the main side-effects of ADT. There are no successful and well-tolerable treatment options available. A possible treatment for hot flushes is stellate-ganglion block (SGB), used as a means of interrupting parts of the sympathetic nervous system involved in temperature regulation.

Objective of this study

Eligibility Criteria:
Inclusion Criteria:

* Male
* Age: \>18 years
* Mean daily flush frequency of 10 or more and a hot flush score of 15 or more
* Treatment with ADT because of prostate cancer
* Absence of any other cause of flushing

Exclusion Criteria:

* Use of medication that affects flushing: oestrogens, progestogens, clonidine, naloxone, paroxetine, fluoxetine, venlafaxine, gabapentin, luteinizing hormone-releasing hormone receptor antagonist
* Still receiving chemotherapy of radiotherapy
* Psychiatric disease
* Any unstable concurrent disease
* Allergic reactions against bupivacaine or contrast media.
Endoscopic Tattooing and Colorectal Cancer

Endoscopic tattooing to facilitate colorectal lesions' identification during laparoscopic surgery is a reliable and widely used technique.

India Ink is the standard option for colonic tattoing. Different studies have been reported significant complications, of which the most common is peritonitis, due to ethylene glycol, phenols and animal-derived gelatine contained in the ink. This local inflammatory reaction is the principal reason of the formation of the adhesions detected during the laparoscopy, that make the intervention more difficult. To prevent infection or inflammatory local reaction India ink solution has to be sterilized and diluted, a cumbersome process. In the last years wide diffusion of another endoscopic ink, Sterile Carbon Particle Suspension, has reduced these complications. Sterile Carbon Particle Suspension is a prepackaged, sterile, FDA-approved formulation of pure carbon particle in suspension, that eliminates the need for preinjection preparation.

In an attempt to evaluate safety and efficacy of endoscopic tattooing in colorectal surgery using two different types of ink, a randomized clinical trial has been designed. Two types of endoscopic ink were evaluated: Sterile Carbon Particle Suspension (Experimental group) and India Ink (Control group) and.


Eligibility Criteria:
Inclusion Criteria:

histologically confirmed malignancy planned for an elective, segmental laparoscopic colectomy.

Exclusion Criteria:

emergency surgery open surgery immune depressant disease immune depressant medication
Surufatinib Combined With Serplulimab and Standard Chemotherapy as First-line Treatment in Advanced Solid Tumors With Neuroendocrine Differentiation

Currently, there are no standard treatment and relevant exploration for solid tumors patients with NED. The study aims to explore the efficacy and safety of surufatinib combined with serplulimab and standard chemotherapy in the treatment ofadvanced solid tumors with NED, in order to provide a new treatment option for advanced solid tumors patients with NED.

This is a single-arm, multi-cohort, open-label, single-center, prospective, exploratory clinical study. We planned to enroll 80 patients who would receive surufatinib plus tislelizumab until disease progression, intolerance, or withdrawal of consent. The study aims to explore the efficacy and safety of surufatinib combined with serplulimab and standard chemotherapy in the treatment of advanced solid tumors with NED, in order to provide a new treatment option for advanced solid tumors patients with NED.

Eligibility Criteria:
Inclusion Criteria:

* Histopathologically confirmed locally advanced or metastatic unresectable ESCC, BTC, PC or GC with an abnormal NED or NE phenotype (without neuroendocrine morphologic features and positive immunohistochemical expression of at least one neuroendocrine marker (CgA, Syn));
* Have at least one measurable lesion according to RECIST v1.1;
* ECOG performance status: 0-1;
* No previous systemic therapy;
* Urine protein\< ++ . If Urine protein ≥ ++ ,the amount of urine protein in 24 hours ≤1.0g;
* Expected survival time \&gt; 3 months;

Exclusion Criteria:

* Have uncontrolled hypertension, defined as systolic blood pressure \&gt;150 mmHg or diastolic blood pressure \&gt;90 mm Hg, while under anti-hypertension treatment;
* With active bleeding or bleeding tendency;
* Severe history of cardiovascular and cerebrovascular diseases;
* Other malignancies diagnosed within the previous 5 years, except basal cell carcinoma or cervical carcinoma in situ after radical resection.
Transverse Abdominus Plane Block Study

Study the effect of laparoscopic guided TAP block on opioid consumption and associated costs using a mixture of dexmedetomidine, dexamethasone, and ropivacaine versus Liposomal bupivacaine (Exparel®) in patients who undergo elective minimally invasive colorectal surgery.

This is a non-inferiority single-blinded randomized trial aiming to study the effect of laparoscopic guided TAP block on opioid consumption and associated costs using a mixture of dexmedetomidine, dexamethasone, and ropivacaine versus Liposomal bupivacaine (Exparel®) in patients who undergo elective minimally invasive colorectal surgery. This study aims to continue improving our current hospital wide effort in reducing opioid consumption and, consequently, the acute and long-term consequences of opioids. It will also complement the current ongoing efforts of the Department of Surgery's quality and safety improvement project in opioid stewardship. Additionally, this dual adjunct TAP solution combination is inexpensive ($28 per injection) and may result in a significant cost savings for the hospital.

Eligibility Criteria:
Inclusion Criteria:

* provision to sign and date the consent form.
* stated willingness to comply with all study procedures and be available for the duration of the study.
* Male and female patients aged 18 and older
* Benign or malignant colorectal disease undergoing laparoscopic, robotic, or a "hybrid" (minimally invasive dissection with a 6-8 cm incision to complete the surgery) colorectal resection with or without an ostomy

Exclusion Criteria:

* Pregnant or breastfeeding patients
* Medical conditions that may interfere with the use of the study medications (e.g., drug allergy),
* Patients with opioid dependence defined as chronic opioid use more than 3 times per week preoperatively
* Incarcerated individuals
* Age less than 18 years-old
* Urgent/emergent operations as defined by need for operation within 24 hours
* Other conditions or general disability or infirmity that in the opinion of the investigator precludes further participation in the study.
* Enrollment in another concurrent study with use of investigational drugs
Effect of Raltegravir on Endothelial Function in HIV-Infected Patients

Recent studies suggest that HIV patients are at increased risk for cardiovascular events; however, the mechanisms underlying this increased risk remain unclear. Our group was one of the first to demonstrate that HIV infection is independently associated with accelerated atherosclerosis, as measured by carotid artery-intima media thickness (IMT), and that HIV-associated inflammation may be driving this accelerated atherosclerosis. The mechanism by which HIV disease independent of any drug-specific toxicity increases the risk of cardiovascular disease during HAART is not known. We hypothesize that even well controlled HIV infection is independently associated with cardiovascular risk and that further decreasing HIV-associated inflammation adding newer antiretroviral agents will also decrease cardiovascular risk.

We will perform a small clinical trial of approximately 50 HIV-infected patients each to study the relationship between HIV infection, inflammation, thrombosis, atherogenic lipoproteins, and measures of atherosclerosis. We propose the following specific aims: Aim 1: To determine the influence of traditional and novel markers of inflammation on endothelial function and IMT progression; Aim 2: To determine if "intensification" with raltegravir in subjects on long-term antiretroviral therapy with clinically undetectable HIV RNA levels will improve endothelial function, and to determine if this effect is mediated by alterations in inflammatory markers, lipoproteins and/or thrombotic factors. For Aim 2, subjects from 2 randomized, double-blind, placebo-controlled raltegravir intensification studies will be asked to co-enroll in this cardiovascular study.


Eligibility Criteria:
Inclusion Criteria:

1. Stable antiretroviral therapy for at least 12 months
2. All plasma HIV RNA levels within the past year must be below level of detection (\< 50 copies RNA/mL), although isolated single values \> 50 but \< 200 copies will be allowed.
3. Screening plasma HIV RNA levels \< 50 copies RNA/mL
4. \>90% adherence to therapy within the preceding 30 days, as determined by self-report
5. Females of childbearing potential must have a negative serum pregnancy test at screening and agree to use a double-barrier method of contraception throughout the study period.
6. CD4\<350 cells/mm3 for at least one year ("immunologic non-responder") or CD4\>=350 cells/mm3 for at least one year ("immunologic responder").

Exclusion Criteria:

1. Ongoing or prior use of any integrase inhibitor or R5 inhibitor.
2. Patients who plan to modify existing antiretroviral therapy in the next 24 weeks for any reason
3. Serious illness requiring hospitalization or parental antibiotics within preceding 3 months
4. Concurrent or recent exposure to any immunomodulatory drugs
5. Advanced liver disease or active hepatitis B or C
6. Patients with systolic blood pressure \<100/70
7. Starting or stopping statin therapy during the trial
Combined Cognitive and Functional Strength Training in Children With cp

Cerebral palsy is primarily a disorder of movement and posture however; it often involves disorder of different aspects of cognitive function.

This study evaluated the effect of FST and cognitive intervention and their combined effect on motor and cognitive functions in children with spastic diplegia. A convenient sample of spastic diplegic CP children, with their age ranging from 8 to 12 years were assigned randomly into four treatment groups

Eligibility Criteria:
Inclusion Criteria:

* chronological age ranged from 8 to 12 years,
* spasticity grade in affected lower limbs ranged between 1 + and 2 according to MAS
* can follow instructions given to them,
* their intelligence level ranged from 65 to 80 according to Stanford Binet intelligence scale, - -- their motor function ranged between Level II \& III according to Gross Motor Functional Classification System Expanded and Revised (GMFCS E\&R).

Exclusion Criteria:

* children who had visual or auditory problems
* children who took any medicine affecting alertness
* fixed deformities in the joints of upper \& lower limbs
* any orthopedic surgery in lower limbs within 6 months before study
* epileptic children.
A Study of Combination Caplet With Loperamide Hydrochloride and Simethicone, and Imodium Express Tablets-lyophilizate Coadministered With Espumisan Capsule in Healthy Volunteers

The purpose of this study is to assess bioequivalence between a Combination caplet with loperamide hydrogen chloride (HCl) 2 milligram (mg) and simethicone 125 mg, and Imodium Express tablets-lyophilizate with loperamide HCl 2 mg (co-administered with Espumisan capsules with simethicone 40 mg), with respect to the single-dose pharmacokinetics of loperamide HCl. The maximum observed concentration (Cmax), and the area under the concentration-vs.-time curve until the last measurable concentration (AUC \[0-t\]) will be used to assess bioequivalence.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) between 18.5 and 30.0 kilogram per meter (kg/m\^2), inclusive, and a total body weight greater than or equal to (\>=) 50.0 kilogram (kg)
* Females of childbearing potential must have a negative urine pregnancy test at the baseline visit
* Male or non-pregnant, non-lactating female agree to the contraceptive requirements (including female partner's use of a highly effective method of birth control for at least 3 months before the study, during the study and for 30 days after the last dose of investigational product)
* A personally signed and dated informed consent document before participating in any study specific procedures, indicating that the participant has been informed of all pertinent aspects of the study
* Willingness and ability to comply with scheduled visits, laboratory tests, and other study procedures specified in the protocol example: swallowing of tablets

Exclusion Criteria:

* Use of medications, prescription medication and/or over-the-counter medication including vitamins, herbal supplements, medicinal plants (example supplements containing garlic extract), and topical preparations of drugs that are systemically absorbed (example steroids and non-steroid anti-inflammatory drugs) within two weeks prior to dosing
* Use of St. John's wort (Hypericum perforatum) within 30 days prior to the first dose of study medication
* Abnormal results of laboratory and instrumental methods of examinations, including electrocardiogram (ECG)
* Females with a positive pregnancy test and/or are breast-feeding
* Females, currently using hormonal contraceptives (including use less than 2 months prior to enrollment)
A Retrospective Study of Patients With Leukemia Relapse in the CNS Treated With CAR T Cells

CAR T cells targeting CD19 have been approved for patients with relapsed or refractory ALL, failing two or more prior protocols. Several institutional-based studies with other CAR T cells targeting CD19 have demonstrated outstanding response rates in patients with refractory disease, and the ability of CAR T cells to clear CNS leukemia. Nevertheless, these cases are sparse and have never been reported collectively.

Here, we aim to retrospectively assess toxicity and long term outcome of patients treated with CAR T cells for CNS relapse of ALL.


Eligibility Criteria:
Inclusion Criteria:

* Prior diagnosis of B-cell acute lymphoblastic leukemia involving the central nervous system
* Treatment with CAR T cells (either on a clinical trial or commercial use) due to this indication
Inflammatory and Metabolic Outcomes After Obese Woman Performed High Intensity Interval Training

The main purpose of this study is to compare the effects of high intensity interval training and moderate intensity continuous training on inflammatory profile and metabolic markers, after 8 weeks of intervention trial in obese women.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index between (30-40 kg/m²)
* age between 25 and 41 years
* to be sedentary

Exclusion Criteria:

* type 1 or type 2 diabetes
* Hypertension
* pregnancy, Lactation
* having undergone bariatric surgery
* psychological disorders, epilepsy, sever neurological disorders
* participation in other moderate, vigorous exercise or nutrition intervention
* acute or chronic cardiovascular disease
* malignant disease
* kidney disease
* lung disease
* hyperthyroidism or hypothyroidism
* smoking any type of cigarette
* joint limitations
* electronic implants (defibrillator, pacemaker)
Topical Corticosteroids on the Incidence of Postinflammatory Hyperpigmentation After QsNdYAG Laser

To investigate the benefit of the application of topical high potency steroid on the incidence of post inflammatory hyperpigmentation after laser treatment.

* The incidence of post inflammatory hyperpigmentation (PIH) after treating lentigines with Q-switched Nd:YAG laser was 78.3%.
* It has been found that the incidence of PIH decreased to 40% after applied topical high potency steroid 2 days after the laser treatment.
* By these anti-inflammatory and anti-PIH effects of the high potency steroid, the investigators aimed that the application of steroid 2 days before and 2 days after the laser treatment would be better reduction in the incidence of PIH after Q-switched Nd:YAG laser.

Eligibility Criteria:
Inclusion Criteria:

* Having multiple lentigines on both sides of the face
* Fitzpatrick skin phototype 3-5

Exclusion Criteria:

* Patients with lesions with any clinical suspicion of being pre-cancerous or skin malignancies of any kind
* Patients who have photosensitive dermatoses
* Pregnancy and lactation woman
* Patients with wound infections (herpes, other) on the day of treatment
* Patients with moderate and severe inflammatory acne, Immunosuppressed patients, history of vitiligo
* Patients with unrealistic concerns/expectations and inability to do the appropriate post-operative care