cyrilzakka/clinical-trials huggingface dataset:
Outpatient Recovery From Acute Kidney Injury Requiring Dialysis

There are currently no therapies to improve the chances of recovering enough kidney function to come off of dialysis after severe acute kidney injury. It is not known if current routine outpatient dialysis treatments are optimized to maximize the chances of recovery. The purpose of this pilot study is to see if we can feasibly and safely provide several changes to the way that dialysis is provided in outpatient dialysis centers which may improve the chances of recovery.


Eligibility Criteria:
Inclusion Criteria:

* AKI-D (acute kidney injury requiring dialysis), attributed at least in part to acute tubular necrosis by clinical nephrology team
* Age ≥ 18 years
* Pre-hospitalization eGFR ≥ 15 mL/min/1.73m2
* Being discharged to a participating outpatient dialysis unit (within 30 miles of UCSF)

Exclusion Criteria:

* Known loop diuretic allergy/intolerance
* Dialysis duration \> 3 months
* Pregnant
* Prisoner
* Unable to consent
* Clinical team declines to allow approach for study
Effect of Fish Oil on Athlete's Executive Function

The goal of this study is to determine the impact of long chain omega-3 PUFA (Polyunsaturated fatty acids) supplementation on executive function in collegiate athletes in a randomized, double-blind, placebo-controlled trial

The main objective of this study is to determine the effect of daily oral intake of a fish oil capsule enriched in eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) on brain EF (Executive Function) and blood-based biomarkers among male collegiate baseball student athletes over the course of an academic school year

Eligibility Criteria:
Inclusion Criteria:

* Wake Forest University National Collegiate Athletic Association (NCAA) Division I baseball male student athletes cleared to participate in university athletics as determined by the team physician
* Age \>/=18 years

Exclusion Criteria:

* Unwillingness to consume a daily dietary supplement over the course of the study
* Allergy to dietary supplement components
* Lipid-lowering medication use
Focus Group Study on the Feeling Tone Mindfulness Course

This is an academic research study aiming to explore the acceptability, feasibility, and effectiveness of a four-week feeling tone mindfulness course by gathering qualitative feedback from course participants in a focus group format.

This is a follow-up study of the four-week feeling tone mindfulness course study, exploring the acceptability, feasibility, and effectiveness of the four-week feeling tone mindfulness course by gathering qualitative feedback from course participants in an online (e.g., Zoom), focus group format. A trained moderator will use a semi-structured interview guide with a set of questions to facilitate focus group discussions. Each focus group session will last for about two hours. With the consent from focus group participants, each focus group will be audio-recorded. After participants have completed the focus group, they are eligible to receive HKD100, as a token of thanks to their support and participation to this focus group study.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 or above
* Speak and understand Cantonese as well as written Chinese to a level where the participant can fully take part in the focus group session without the need for translation support
* Have means to access online teleconferencing meeting software (e.g., Zoom), online surveys (to give their informed consent and to schedule a focus group session), online materials, and Short Message Service (SMS) or WhatsApp messenger.
* Participants who have completed the four-week feeling tone mindfulness course

Exclusion Criteria:

* N/A
Evaluation of the Use of RELAX Glasses on Anxiety of Patients Undergoing Dental Extraction > 2 Teeth, Under Local Anesthesia, Compared With Those Not Using Glasses

The vast majority of tooth extraction surgery is performed under local anaesthetic, and can be a source of anxiety. In their 2015 article, Appukuttan et al studied the anxiety felt by 1148 patients prior to tooth extraction, and reported up to 82% of patients anxious before a procedure.

In 2020, Yamashita et al demonstrated the value of virtual reality in reducing patient anxiety during the extraction of three impacted mandibular molars, with no clear effect on the pain felt by the patient.

The use of a virtual reality headset has been shown to reduce anxiety in dental surgery or in hand surgery under local anesthesia with the WALANT technique. On the other hand, virtual reality and the use of 3D can cause discomfort and side effects such as nausea and dizziness. Audiovisual distraction is also known to be effective in reducing pain and anxiety in patients, with fewer side effects.

The investigators have therefore chosen to use RELAX® eyewear. They wish to study its effect on anxiety, pain and overall patient and surgeon satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* Patient undergoing dental extraction \> 2 teeth under local anesthesia;
* Over 14 years of age on the day of inclusion;
* Patient with written consent or additional parental consent for minors;
* Socially insured patient;
* Patient willing to comply with all study procedures and duration.

Exclusion Criteria:

* Medical history contraindicating RELAX glasses
* Known and current abuse of alcohol and/or illicit drugs that may interfere with patient safety and/or compliance;
* Any condition that would render the patient unfit for the study: current presence of cognitive disorders (MMS \< 15), severe psychiatric disorders (bipolar disorders, psychotic disorders according to DSM-V classification);
* Major anxiety requiring preoperative anxiolytics;
* Patient under court protection;
* Patient participating in another study;
* Patient's refusal to use glasses;
* Visually impaired or blind patient.
Microcirculation of the Abdominal Skin After Deep Inferior Epigastric Artery Perforator Flap Procedure

The purpose of this study was to perform a quantitative perfusion study of the undermined abdominal skin in deep inferior epigastric artery perforator flap breast reconstruction patients in order to obtain more knowledge on perfusion dynamics. Laser Doppler perfusion imaging (LDPI) was used to evaluate this.

Microcirculatory changes were monitored in the abdominal skin of 20 consecutive patients. Measurements were taken and recorded within four standardized zones covering the skin between the xiphoid process and the upper incisional boundary of the flap (zone 1-4; cranial to caudal).

Background: No studies have assessed the perfusion of the undermined abdominal skin in breast reconstruction with deep inferior epigastric artery perforator flap. A greater understanding of the procedure's impact on the perfusion of the abdominal skin can be valuable in predicting areas susceptible to necrosis.

Methods: Microcirculatory changes were monitored in the abdominal skin of 20 consecutive patients undergoing breast reconstruction with a deep inferior epigastric artery perforator flap. Quantitative mapping was performed with laser Doppler perfusion imaging at seven set intervals. Measurements were taken and recorded within four standardized zones covering the skin between the xiphoid process and the upper incisional boundary of the flap (zone 1-4; cranial to caudal).

Eligibility Criteria:
Inclusion Criteria:

* Secondary, unilateral breast reconstruction with a DIEAP
* All smokers stopped smoking 4 weeks prior to surgery

Exclusion Criteria:

* Metastatic disease
* Bilateral breast reconstruction
Efficacy of L-menthol on Breathlessness in Chronic Obstructive Pulmonary Disease

The purpose of this study is to assess the effect of L-menthol on breathlessness in patients with chronic obstructive pulmonary disease (COPD).

Breathelssness (Dyspnea) is a cardinal symptom in patients with chronic obstructive pulmonary disease (COPD), often triggered by daily-life physical activities. Despite optimal treatment of the underlying disease, many patients still suffer from chronic and disabling dyspnea for many years, leading to exercise intolerance, and worse morbidity and mortality. To date, an effective pharmacologic treatment to relieve chronic dyspnea is lacking. Recent pilot data support that inhaled L-menthol can markedly decrease laboratory-induced dyspnea in COPD patients, likely through increased afferent feedback of airflow in the airways by inducing a cooling sensation through olfactory stimulation. The aim of this study is therefore to assess the effectiveness and mechanisms of inhaled menthol for relief of chronic dyspnea in patients with COPD.

Eligibility Criteria:
Inclusion Criteria:

* The subject has given written consent to participate in the study
* Diagnosis of COPD confirmed by spirometry and a FEV1 \< 80% of predicted post bronchodilator at baseline
* age 18 years or older
* able to cycle
* able to understand and talk Swedish to participate in the study procedures, as judged by the Investigator.

Exclusion Criteria:

* Resting peripheral oxygen saturation (SpO2) \< 92%
* hospitalization or clinical instability during the last four weeks
* treatment with supplementary oxygen at rest or during exercise
* contraindication to exercise testing in accordance with clinical practice guidelines
* expected survival shorter than six months as judged by the Investigator
* medical conditions including congestive heart failure, acute coronary artery disease, neuromuscular diseases, severe psychiatric illness, and olfaction disorder.
Multi-organ Transit Time Acquisition Using Contrast Ultrasound

Echocardiographic contrast will be administered to volunteers for the purpose of measuring transit time through various organs/vascular beds


Eligibility Criteria:
Inclusion Criteria:

* at least 18 years old
* able to give informed consent

Exclusion Criteria:

1. Known allergic reaction to Definity ultrasound contrast
2. Pregnancy/Nursing - as assessed/disclosed by the participant
Clinical and Radiographic Assessment of a Novel Wedge Shape Implant Placed in Edentulous Narrow Ridges

The aim is to clinically and radiographically assess a novel wedge implant placed in narrow ridges.

* 60 wedge implants (Rex Implants, Columbus, OH, USA) will be placed using Piezosurgery® following either a bone consumption (n=30) or bone expansion technique (n=30). Each group (bone consumption and bone expansion) will be divided into 2 surface treatments: machined transcortical portion (n=15) and roughened transcortical portion (n=15).
* Record the time needed to place each implant.
* ISQ will be evaluated at Day 0, 3 weeks, 6 weeks, 3 months, 4 months, and 6 months after implant placement.
* Periapical radiographs will be performed at implant placement, loading. and 1, 3, and 5 years after loading to assess marginal bone stability.
* Buccal bone height and lingual and buccal bone thickness will be recorded post-intervention, at the time of functional loading, and at 12, 36, and 60 months after loading with CBCT.
* Digital impressions will be taken post-operatively, at loading and at 12 months after loading to monitor gingival profile.


Eligibility Criteria:
Inclusion Criteria:

1. Partially or totally edentulous patients presenting indications for a prosthetic rehabilitation supported by the upper or lower jaw implants on the basis of an accurate diagnosis and treatment planning;
2. the bone crest must be completely healed (at least six months after the loss of teeth);
3. the residual bone crest must have a width between 3 and 5 mm;
4. presence of at least 10 mm of bone height available for implant placement; 5) patient age \> 18 years;

6) the patient must not wear any type of removable dentures on the treated area; 7) the patient must be capable of following the study protocol; and 8) written informed consent must be provided

Exclusion Criteria:

1. acute myocardial infarction within the last two months;
2. Uncontrolled coagulation disorders;
3. uncontrolled diabetes (HBA1c\> 7.5);
4. radiation therapy to the head \\ neck region in the last 24 months;
5. immunocompromised patients, HIV positive or receiving chemotherapy in the last five years;
6. past or present treatment with intravenous bisphosphonates;
7. psychological or psychiatric problems;
8. abuse of alcohol or drugs;
Office Hysteroscopy in Infertility Work-out: the Role of Endometrial Hyperplasia in Southern Italian Women

To assess the prevalence of endometrial hyperplasia (EH), endometrial intraepithelial neoplasia (EIN) and endometrial carcinoma between obese and not obese women undergoing IVF techniques for primary or secondary infertility.

Endometrial cancer and pre-neoplastic diseases represent the most incident gynecologic malignant pathologies found in women.1 Although diagnosed in postmenopausal patients, it can be also found in younger patients, especially when associated with some risk factors. Those include weight gain and lifestyle habits, such as consumption of fatty foods that increase estrogen levels. The positive association be- tween infertility and EC is well established. Infertile women with irregular menstrual periods, oligomenorrhea, or chronic anovulation have a risk of developing

A prospective cohort study conducted at "Fertility Center, OB/GYN Unit, Department of Woman, Child and General and Specialized Surgery, University of Campania "Luigi Vanvitelli", Naples, Italy".

Eligibility Criteria:
Inclusion Criteria:

* Women undergoing office hysteroscopy prior to IVF techniques

Exclusion Criteria:

* Severe comorbidities (i.e. cardiac, metabolic, neurologic diseases)
ADVANCE: An Observational Study To Determine Bortezomib Safety and Effectiveness at First Relapse After Participation In First Line HOVON-49/50 Clinical Studies.

The primary aim of this observational study is to collect safety and effectiveness data for bortezomib used at first relapse in a group of multiple myeloma patients who received specific and well defined first line treatments within previous clinical studies.

There is a need by physicians to evaluate the results of bortezomib treatment in a homogenous patient population with regard to the multiple myeloma treatments in first line. For that reason the current study, ADVANCE, is designed to structurally collect data on the daily practice use of bortezomib as treatment after first relapse in patients with specific and well defined first line treatments (i.e. patients who participated in the HOVON-49 or HOVON-50 study). In both HOVON studies patients were randomized to either receiving thalidomide or not, as a part of the first line treatment. Therefore, the effect of pre-treatment with thalidomide on duration, effectiveness and safety of the bortezomib treatment after first relapse can be studied specifically. The analysis of this particular type of data will, however, be descriptive. All adverse events, regardless of seriousness, severity, or presumed relationship to bortezomib therapy will be recorded on the case report form, i.e., a form for each patient in the study on which all needed data are recorded, and reported to the sponsor within current timelines. The sponsor assumes responsibility for appropriate reporting of adverse events to the regulatory authorities. This project is a 'post authorization study (PAS)'. This means that only routinely available medical data are collected, with the patients' permission, and no additional interventions or diagnostic procedures should be done specifically for this study. Because the study is observational, dosage, administration and duration of treatment is at discretion of the treating physician

Eligibility Criteria:
Inclusion Criteria:

* Patients have to sign a statement that they agree with collection of their clinical data for this project
* patients had a first relapse or progressive disease after treatment in the HOVON-49 or HOVON-50 study and will be treated with bortezomib.

Exclusion Criteria:

* Prior enrollment in HOVON-54 study
A Study of Tirzepatide (LY3298176) Versus Insulin Degludec in Participants With Type 2 Diabetes

The purpose of this study is to compare the effect of the study drug tirzepatide to insulin degludec on blood sugar levels in participants with type 2 diabetes. The study will last about 67 weeks and may include up to 22 visits.


Eligibility Criteria:
Inclusion Criteria:

* Participants must:

  * Have been diagnosed with type 2 diabetes mellitus (T2DM)
  * Have HbA1c between ≥7.0% and ≤10.5%
  * Be on stable treatment with unchanged dose of metformin or metformin plus an SGLT-2 inhibitor for at least 3 months before screening
  * Be of stable weight (± 5%) for at least 3 months before screening
  * Have a BMI ≥25 kilograms per meter squared (kg/m2) at screening

Exclusion Criteria:

* Participants must not:

  * Have type 1 diabetes mellitus
  * Have had chronic or acute pancreatitis any time prior to study entry
  * Have proliferative diabetic retinopathy or diabetic maculopathy or nonproliferative diabetic retinopathy requiring acute treatment
  * Have disorders associated with slowed emptying of the stomach, or have had any stomach surgeries for the purpose of weight loss
  * Have acute or chronic hepatitis, signs and symptoms of any other liver disease, or blood alanine transaminase (ALT) enzyme level \>3.0 times the upper limit of normal (ULN) for the reference range, as determined by the central laboratory. Participants with nonalcoholic fatty liver disease (NAFLD) are eligible for participation in this trial only if their ALT level is ≤3.0 the ULN for the reference range
  * Have an estimated glomerular filtration rate \<45 mL/minute/1.73 m2 (or lower than the country specific threshold for using the protocol required dose of metformin per local label)
  * Have had a heart attack, stroke, or hospitalization for congestive heart failure in the past 2 months
  * Have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2
  * Have been taking any other diabetes medicines other than metformin, or metformin plus an SGLT-2 inhibitor during the last 3 months
  * Have been taking weight loss drugs, including over-the-counter medications during the last 3 months
Evaluation of Efficacy and Safety of VX-548 for Painful Lumbosacral Radiculopathy (PLSR)

The purpose of the study is to evaluate the efficacy and safety of VX-548 in treating participants with PLSR.


Eligibility Criteria:
Key Inclusion Criteria:

* Body weight greater than or equal to (\>=)45 kilogram (kg)
* Body mass index (BMI) less than or equal to (\<=) 40 kg/ meter square (m\^2)
* Diagnosis of PLSR for greater than (\>)3 months as per criteria pre-specified in the protocol
* Weekly average of daily NPRS score \>=4 and \<10 with limited variation in the 7-day Run-in Period

Key Exclusion Criteria:

* More than 3 missing daily NPRS scores during the 7-day Run-in Period
* Moderate or severe painful neuropathy other than PLSR as pre-specified in the protocol
* History of prior lumbar spine surgery (e.g., discectomies, laminectomies, foraminotomies, or fusion)

Other protocol defined Inclusion/Exclusion criteria may apply.
AS-OCT Study of Cornea and Tear Film Parameters in SLE Patients

The aim of thie study to assess tear film parameters such as tear meniscus height (TMH), tear meniscus area (TMA), and tear meniscus depth (TMD). In addition, corneal pachymetry and epithelial thickness maps in SLE patients and compared to healthy subjects of similar age and gender.

Systemic lupus erythematous (SLE) is a relapsing and remitting autoimmune connective tissue disorder that can affect many organs such as skin, joints, kidneys, eye, and brain (1) . SLE has a global prevalence of 0.3 to 23.2 cases per 100,000. Women are more likely than men to develop the disease. Four out of the following 11 diagnostic criteria are sufficient for the diagnosis of SLE, malar rash, discoid rash, oral ulcers, non-erosive arthritis, serositis, photosensitivity, renal disorder, neurological disorder, hematological disorder, immunological disorder, and presence of antinuclear antibodies. (2,3)

Ocular manifestations occur in about one third of SLE patients with keratoconjunctivitis sicca being the most common manifestation which is characterized by decreased tear film aqueous layer. Scleritis, retinal vasculitis (which is often associated with CNS lupus), and papillitis are considered as the most serious ocular manifestations. (4)

Corneal involvement in SLE affects the superficial epithelium, resulting in superficial punctate keratitis, which is believed to be caused by Sjögren\&#39;s syndrome (SS). However, some cases of non-infiltrative and infiltrative peripheral ulcerative keratitis have been identified (5) .

Schirmer\&#39;s test and fluorescein breakup time test (FBUT) are two common clinical tests used to analyze tear film. (6,7) Using an in vivo, non- contact technique, anterior segment optical coherence tomography (AS- OCT) is now used to image the tear film, measure the lower tear film height and area, measure corneal thickness (pachymetry), and measure surface epithelial thickness. (8,9)

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years old..
2. Patients with SLE diagnosed by a rheumatologist with no ocular involvement upon clinical examination

Exclusion Criteria:

* 1. Patients with history of intraocular surgery as cataract surgery ,retinal detachment surgery, anti-glucoma surgery.

  2. Patients with history of any corneal refractive surgery as LASIK, PRK. 3. Patients with significant media opacity as corneal opacity, cataract. 4. Patients with ocular diseases as glaucoma, uveitis. 5. Patients with any retinal affection as pathological myopia, macular hole, age related macular degeneration and retinal vascular occlusion.

  6. Patients with systemic diseases as diabetes mellitus, hypertension, abnormal kidney function.
Phase II Study of the Multichannel Auditory Brain Stem Implant for Deafness Following Surgery for Neurofibromatosis 2

OBJECTIVES: I. Define the tonotopocity of multichannel brain stem stimulation and use this information to better program the auditory brain stem implant for an individual.

II. Optimize device fitting by combining monopolar and bipolar stimulation, and individual psychoacoustic channels for each patient, to increase the number of usable information channels for each patient and reduce or eliminate undesirable side effects.

III. Evaluate performance and learning effects using optimized fitting procedures.

PROTOCOL OUTLINE: Patients undergo surgery to remove the first side or second side tumor, during which the multichannel auditory brain stem implant is implanted. Initial stimulation is conducted 4-6 weeks after surgery.

Patients are followed every 3 months for the first year, then annually thereafter.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Confirmed diagnosis of neurofibromatosis type 2 Scheduled to undergo first side or second side tumor removal First side implantation performed only on patients with onset of symptoms prior to age 40 --Prior/Concurrent Therapy-- If a nonfunctional auditory brain stem implant (ABI) is present (implanted during the removal of a first side tumor), a multichannel ABI may be implanted during the removal of a second side tumor --Patient Characteristics-- English is the primary language