cyrilzakka/clinical-trials huggingface dataset:
An Investigator-initiated Study to Evaluate Safety and Efficacy of ARINA-1 in People With a Tracheostomy

The goal of this investigator-initiated, open label study is to evaluate the safety and efficacy of ARINA-1 in people with a tracheostomy.

Participants will attend study visits at Screening, Baseline, Day 14, Day 28, and Day 56. There will be 3 safety phone calls at Days 2, 7, and 21. Participants will nebulize the ARINA-1 solution twice daily for 28 days


Eligibility Criteria:
Inclusion Criteria:

1. Tracheostomy for ≥6 months with no anticipated changes to tracheostomy status within the next 3 months from screening visit
2. Males or females 18-75 years old at time of consent
3. Willing and able to comply with the protocol and visit schedule
4. Subject or legal authorized representative capable of giving informed consent. Determination of subject capacity to give informed consent will be determined by investigators and guided by principles set forth in the Declaration of Helsinki (World Medical Association, 2013) and by WakeMed Health \& Hospitals guidance (Patient Competency and Decisional Capacity - Legal Affairs Tip Sheet/FAQ).

Exclusion Criteria:

1. Inability to speak or understand English
2. Positive urine pregnancy test at screening and/or baseline visit, if applicable
3. Active breastfeeding status
4. Diagnosis of cystic fibrosis or primary ciliary dyskinesia
5. History of lung transplant
6. Listed for lung transplant
7. Inability to tolerate nebulized treatments
8. Planned decannulation before completion of this study
9. Exacerbation or infections requiring any acute antibiotics, urgent care visit, emergency department visit or hospitalization within 14 days of screening visit
10. Previous intolerance to hypertonic saline (HTS)
11. Initiating a chronic azithromycin or any new inhaled maintenance therapy \< 28 days prior to baseline visit
12. Initiating any N-acetyl-cysteine-containing (NAC), ascorbic acid or glutathione (GSH)-containing therapy (oral or nebulized) \< 28 days prior to baseline visit
13. Intolerance to NAC or GSH
14. Intolerance to bronchodilator (e.g., Albuterol)
15. Significant comorbidities that in the opinion of the investigator would reduce the safety of the subject or interfere with the ability to interpret study data
16. Currently participating in or have participated in other interventional (drug or device) clinical study within 90 days of the baseline visit
17. Receiving a vaccination within 14 days of the baseline visit
Comparison of Tramadol vs Remifentanyl Patient Controlled Analgesia for Second Trimester Abortions

Patients undergoing second trimester abortions will recieve either patient controlled analgesia with either remifentanyl or tramadol for pain alleviation.

We beleive both to be equally effective for pain alleviation.

Women undergoing second trimester abortions will recieve patient controlled analgesia eith either tramadol or remifentanyl.

Patients will not know what they are recieving.

Patients in the tramadol goup will get a loading dose of tramadol and metocloparamide while the women in the remifentanyl group will be given a loading placebo.

Women will then be attached to one of the two patinet controlled analgesia protocols.

Throughout their laboring process they will be monitored for blood pressure, pulse, breathing rate, sedation score and nausea.

Additional medicatyion will be given for nausea.

If woman are still in pain the patient controlled analgesia settings will be set to deliver a higher dose. If the woman remains in pain, she will be given an additional per os medication.If this still does not alleviate pain, the option of epidural analgesia will be offered.

Eligibility Criteria:
Inclusion Criteria:

Woman undergoing 2nd trimester abortion -

Exclusion Criteria:

* Seizure disorder

  - \* Psychiatric disorder
* Inability to recieve patient controlled analgesia
* Allergy to tramadol or remifentanyl
Does Antidepressant Use Blunt Adaptations to Exercise?

Nearly one out of ten US adults over the age of 18 currently takes antidepressant medication, which can also treat other conditions such as anxiety. Combining pharmaceutical treatment with exercise may yield even greater benefits than using drugs alone, and this is commonly prescribed for depression. However, little is known about the drug-exercise interactions and their influence on metabolic health. A common side effect of antidepressant use is weight gain, particularly abdominal (visceral) fat, which is highly detrimental to overall health. Exercise is a well-known counter to abdominal fat accumulation. The aim of the proposed study is to compare the efficacy of 6 weeks of exercise training to reduce abdominal fat in healthy overweight/obese adults either taking or not taking antidepressant medication. Twenty-four inactive overweight/obese, but otherwise healthy, adults will complete 6 weeks of an exercise training intervention consisting of three days of aerobic exercise training per week. Participants will either not be taking antidepressant medication or will have been on their medication for at least 1 year. The primary outcome will be abdominal fat determined by waist circumference and dual x-ray absorptiometry, which is considered one of the optimal methods for assessment of abdominal fat.


Eligibility Criteria:
Inclusion Criteria:

* Participants will be English language speakers
* Male or females between the ages of 18-40.
* All genders and ethnicities.
* Healthy as assessed by a health history questionnaire (no diagnosed physical diseases or conditions preventing participation in exercise).
* Individuals on antidepressants will be recruited if they are consuming selective serotonin reuptake inhibitors (SSRIs) and selective serotonin and norepinephrine reuptake inhibitors (SNRIs) only. Participants will send prescription information after consent has been provided as part of the screening process, including the dose and frequency of medication.
* A body mass index (BMI) of 25 or greater is required for inclusion.

Exclusion Criteria:

* Inability to complete moderate-vigorous exercise.
* Taking first generation antidepressant medications or other medications such as monoamine oxidase inhibitors (MAOI).
* Other medications, such as medications for attention-deficit hyper-activity disorder or metabolism
* Undiagnosed depression that may be unveiled during the screening process.
Patterns of Urinary Bladder Cancer in Darfur, Suda

Background: Bladder cancer (BC) exhibits extreme heterogeneity regarding clinical outcome, etiology, histology, and geographic distribution. Recent clinical observations point to alterations in the BC pattern in the Sudan, possibly as a result of lifestyle changes brought on by the enormous migration from rural to urban locations. This study aimed to identify the pattern of bladder cancer in Darfur.

Patients and Methods: A cross sectional, hospital-based study, it was conducted inNyala specialized hospital, during the period from (2020 to 2022), included one hundred and five patients with bladder mass matching the inclusion criteria were studied over the diversity of demographic data , clinical finding, pathological type and possible risk factors .


Eligibility Criteria:
Inclusion Criteria:

* All Sudanese pts who lives in Darfur and presented with urinary bladder mass.
* Adult above 18 years

Exclusion Criteria:

* Patient who does not live in Darfur.
* Patients refused to participate in the study.
Effects of Trying to Conceive Using an Home- or Hospital-based Ovulation Monitoring on Stress

The goal of this observational study is to compare the difference of stress level and anxiety and depression between couples under home ovulation monitoring and hospital ultrasound monitoring.And whether it has a negative effect on the couple's sexual behavior.The participants were all healthy couples with fertility requirements from the reproductive Center of the First Hospital of Jilin University.The main questions it aims to answer are:

* \[question1\] : Does ultrasound monitoring of ovulation increase stress levels and anxiety and depression in couples trying to conceive?
* \[question2\] : Does ovulation monitoring affect couples' sexual function and satisfaction? Participants will be asked to fill out questionnaires three times over four menstrual cycles.

The goal of this observational study is to compare the difference of stress level and anxiety and depression between couples under home ovulation monitoring and hospital ultrasound monitoring.And whether it has a negative effect on the couple's sexual behavior.The participants were all healthy couples with fertility requirements from the reproductive Center of the First Hospital of Jilin University.

Each couple needs to complete three questionnaires, one after informed consent, the second after two menstrual cycles, and the third after four menstrual cycles. If the woman becomes pregnant within 4 cycles, the investigation will be stopped.

The study was divided into two groups，home ovulation monitoring group and hospital ovulation monitoring group.The questionnaires used were the Perceived Stress Scale (PSS) , the Hospital Anxiety and Depression Scale (HADS) ,Sexual functioning was assessed with the Female Sexual Function Index (FSFI) ,the International Index of Erectile Function (IIEF) and premature ejaculation diagnostic tool（PEDT）.

Eligibility Criteria:
Inclusion Criteria:

* Normal sexual activity, no contraception for more than six months, and no ovulation monitoring in any way before Preparing for ovulation monitoring

Exclusion Criteria:

* Couples with contraindications to pregnancy The man was diagnosed with severe oligozoospermia and azoospermia
Control-IQ Observational (CLIO) Post-Approval Study

Post-approval 522 study designed to collect primarily safety data on the US FDA-cleared product, t:slim X2 insulin pump with Control-IQ technology (Control-IQ system).

Post-approval study designed to collect primarily safety data on the US FDA-cleared product, t:slim X2 insulin pump with Control-IQ technology (Control-IQ system), by assessing the rate of severe hypoglycemia (SH) and diabetic ketoacidosis (DKA) during the first 12 months of use. Secondary endpoints assessing the effectiveness of this product in real-world use by assessing the impact on patients' glycemic outcomes and user experience will also be collected. The Control-IQ system will be used as intended and in accordance with FDA-approved labeling.

Eligibility Criteria:
Inclusion Criteria:

* Patients with self-reported type 1 diabetes who have been prescribed the Control-IQ system.
* At least 6 years of age
* Using Humalog or Novolog insulin
* For females, not pregnant or planning pregnancy in the next 12 months.
* Agreement to use the t:slim X2 with Control-IQ technology, and to continue use for at least 12 consecutive months after study enrollment.
* Agree to provide HbA1c result, obtained within the 6-month period prior to enrollment.
* Ability to respond to alerts and alarms, and to provide basic diabetes self-management.
* Patients who reside full-time in the United States.
* Willingness to download the t:connect Mobile application to their Smartphone and keep it active throughout the study. Patients unable to use t:connect Mobile application must be willing to manually upload their insulin pump data to t:connect every three months and at the completion of the study.
* Subject has read, understood and agreed to participate in the study, and has electronically signed the Informed Consent Form (ICF).

Exclusion Criteria:

* Self-reported type 2 diabetes
* \< 6 years of age
* Use of any glucose-lowering therapy other than Humalog or Novolog insulin
* Inability to respond to alerts and alarms, or to provide basic diabetes self-management.
* Pregnancy
* Subjects who have not signed the ICF.
Short-term Renal Hemodynamic Effects of Tolvaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD)

The purpose of the trial was to determine the short-term effects of tolvaptan in patients with autosomal dominant polycystic kidney disease (ADPKD) at various levels of renal function.

Renal function was assessed during screening with the estimated glomerular filtration rate (eGFR), which was calculated with the 4-variable modification of diet in renal disease (MDRD) equation using a minimum of 2 creatinine measurements. The eGFR values were used to categorize participants into 1 of 3 mutually exclusive strata (\> 60 \[Group A\], 30 to 60 \[Group B\], and \< 30 \[Group C\] mL/min/1.73 m\^2). Each of the 3 groups received the same tolvaptan treatment.

During the 3-week treatment period, participants were up-titrated on a weekly basis from 45/15 mg to 60/30 mg to 90/30 mg (AM and PM \[8 hours later\] split-dose) to the maximally tolerated dose. The 3-week treatment period was followed by a 3-week post-treatment period during which no study medication was administered.

The effects of the highest tolerated split-dose of tolvaptan on renal hemodynamics and pharmacokinetic and pharmacodynamic parameters were assessed throughout the 6 weeks of the study. The reversibility of changes during the post-treatment period after withdrawal of the drug was determined and the acute transitory effects on kidney volume were also explored.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of autosomal dominant polycystic kidney disease (ADPKD) by Ravine criteria.

Exclusion Criteria:

* Renal replacement therapy.
* Use of therapies for the purpose of affecting polycystic kidney disease (PKD) cysts.
* Evidence of significant renal disease, eg, active glomerular nephritides, renal cancer, single kidney.
* Significant risk-factors for renal impairment, eg, chronic use of diuretics, advanced diabetes, use of nephrotoxic drugs.
* History of significant coagulation defects or hemorrhagic diathesis.
Toripalimab Adjuvant Therapy in Subjects With Resected Esophageal Squamous Cell Carcinoma Who Achieved Pathological Complete Response (pCR)

The goal of this clinical trial is to assess the 1-year DFS rate of toripalimab adjuvant therapy in participants with resected esophageal squamous cell carcinoma (ESCC) who achieved pCR. The main questions it aims to answer are:

* The toripalimab adjuvant therapy could impove the 1-year DFS rate in participants with rescted ESCC who achieved pCR?
* Is this treatment regimen safe? Researchers will compare toripalimab adjuvant therapy to clinical observation to see if toripalimab could improve the 1-year DFS rate.

Participants will receive toripalimab 240 mg IV once every 3 weeks for one year or clinical observation.


Eligibility Criteria:
Inclusion Criteria:

* Stage II or III esophageal cancer with histologically confirmed predominant squamous cell carcinoma at initial diagnosis;
* Subjects must complete preoperative neoadjuvant therapy (unlimited treatment regimen) before being assigned to treatment and then undergo surgery;
* Subjects must undergo complete resection (R0), be surgically determined to be disease-free and have a negative margin on the resected specimen, defined as no viable tumor within 1 mm of the proximal, distal, or surrounding resection boundary;
* Subjects must have no residual pathology, the primary tumor is pCR, and the pathology report of the resected lymph nodes is ypN0;
* ECOG performance status of 0 or 1;
* The laboratory test meet the following requirements:

Bone marrow function: neutrophils ≥ 1.5×10(9)/L, platelets ≥ 100×10(9)/L, hemoglobin ≥ 90 g/L Liver function：Total bilirubin ≤ 1.5 x ULN；AST and ALT ≤ 3 x ULN Renal function：Cr ≤ 1.5 x ULN，Ccr ≥ 50 ml/min.

Exclusion Criteria:

* Subjects with stage M1 resectable disease；
* Received treatments for resected esophageal cancer (e.g., immunotherapy , chemotherapy, targeted therapy, radiotherapy, or biologic therapy);
* Known to be allergic, highly sensitive or intolerable to research-related drugs or excipient
* In the past 5 years, there were other malignant tumors, melanoma skin cancer or ervical carcinoma in situ were excepted.
Acoustic Stimulation During Restricted Sleep After Sleep Deprivation

The purpose of this study is to determine if brief sounds or tones presented within a restricted period of recovery sleep after a period of sleep deprivation will enhance restorative properties and improve performance during a subsequent period of wakefulness.


Eligibility Criteria:
Inclusion Criteria:

* Healthy men and non-pregnant, non-lactating women 18 to 39 years of age (inclusive)
* Must demonstrate adequate comprehension of the protocol, by achieving a score of at least 80% correct on a short multiple-choice quiz. Individuals who fail to achieve a passing score on the initial quiz will be given one opportunity to retest after a review of protocol information. Individuals who fail the comprehension assessment for the second time will be disqualified.

Exclusion Criteria:

* You must have learned English as your first language
* You must have a body mass index (BMI) below 30 (this is a mathematical calculation of your height and weight)
* You must not have current or a history of sleeping problems (for example, insomnia or sleep apnea), or symptoms that indicate a potential sleep disorder
* You must get an average of 6-9 hours of sleep per night and maintain a normal sleep/wake schedule
* You must not drink excessive amounts of caffeine, alcohol, or smoke cigarettes regularly
* You must not be on certain medications (determined on a case by case basis)
* You must test negative for illicit drugs
* Women must not be pregnant or nursing
* You must not be participating in another ongoing clinical trial
* You must have a social security number or tax identification number in order to be paid for screening and participation in the study
* You cannot have a history of the following conditions: Cardiovascular disease, a neurologic disorder, pulmonary disease requiring inhaler use, kidney disease or kidney abnormalities, liver disease of liver abnormalities, a history of psychiatric disorder requiring hospitalization or medication within the last two years or for a continuous period of more than 6 months in the last ten years
Optic Nerve Stimulation To Prevent Visual Deficits After Endoscopic Cranial Approaches

Assessing the function of the optic nerve is paramount during various neurosurgical procedures. Effective optic nerve monitoring has remained elusive as Visual Evoked Potentials (the current existing tool) provides only diffuse and delayed assessment of nerve function. Here, the investigators propose a prospective study involving adult patients (aged 18 years and older) undergoing endonasal or open cranial approaches around the optic nerves, who will receive pre- and post-operative visual evaluations. During surgery, the optic nerve and chiasm will be stimulated, and the response will be recorded in both eyes and the occipital cortex via skin electrodes. The investigators aim to utilize anterograde optic nerve microstimulation to assess the nerve's integrity during open and endoscopic cranial approaches. Electrophysiological readings will be acquired, as is routine in the operating room, by our team of experts, and intraoperative findings will be correlated with post- surgical clinical outcomes. Our objective is to utilize existing technology in the operating room to safely and effectively monitor optic nerve function during surgery.

Our hypothesis is that utilizing anterograde optic nerve microstimulation during open and endoscopic cranial approaches will allow for more accurate and real-time assessment of optic nerve function compared to the current standard of Visual Evoked Potentials. The investigators predict that this novel approach will lead to improved intraoperative monitoring and better correlation with post- surgical clinical outcomes.

The study design proposed is interventional and prospective. It involves implementing a novel approach, anterograde optic nerve microstimulation, during surgical procedures to assess optic nerve integrity. This design entails actively intervening during the surgical process to stimulate the optic nerve and record responses, indicating an interventional approach.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with suprasellar tumors including meningiomas, craniopharyngiomas and pituitary adenomas.
* Must not present with any permanent or temporal visual deficit.
* Must receive an open or endoscopic endonasal procedure as part of their care.

Exclusion Criteria:

* Preexisting visual impairments unrelated to the tumor.
* History of prior cranial surgeries or radiation therapy.
* Significant cognitive impairment or inability to provide informed consent
* Contraindications to microstimulation procedures such as uncontrolled coagulopathy or active infection.
* Patients with tumors located outside the sellar region or those requiring emergent or urgent surgery due to life-threatening complications.
* Additionally, individuals with systemic conditions or comorbidities that may significantly impact visual function or surgical outcomes, such as uncontrolled diabetes mellitus or severe cardiovascular disease.
Early Integrated Supportive Care Study for Gastrointestinal Cancer Patients

Currently at the BC Cancer Agency, oncologists decide when to refer a patient to the Pain and Symptom Management/Palliative Care (PSMPC) team, and their decisions are made subjectively and without standard guidelines/symptom assessment tools. Patients are often referred late in their treatment. The PSMPC team sees patients in their own clinic, separately from the oncologists, and do not often collaborate in a patient's care.

Early integration of palliative care into oncological care has been shown to improve quality of life and to prolong survival, as well as to reduce inappropriately aggressive oncological care at end of life, and reduce costs of care. We will test an early oncology-integrated palliative care model, with the aims of determining whether 1) the introduction of PSMPC support at the time of diagnosis leads to better symptom management and quality of life of patients, 2) early integration of palliative care into medical oncology care reduces aggressiveness of cancer treatment near end of life, and 3) a fully integrated service delivery model is sustainable.

Gastrointestinal (GI) medical oncologists will be assigned to intervention or control groups, according to whether or not they have clinics scheduled on 2 specific half days each week, to coincide with PSMPC clinics. New patients attending the specified clinics under each oncologist will be automatically fall under whichever group their oncologist has been assigned. Control patients will be those seen at clinics other than the 2 specified intervention clinics.

Patients will be approached for study participation in the waiting room of the GI clinic as they await their first oncology appointment. Those who agree to participate will be asked to complete a symptom assessment questionnaire at baseline and once a month for 4 months. This timing is meant to coincide with their regularly scheduled follow up appointments with the GI oncologist.

Symptom scores from the completed assessment forms will be entered into a study database, created with the BC Cancer Agency IDs of the study participants alongside an anonymized study ID.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with a gastrointestinal (GI) cancer
* have appointments in GI clinic during study days
* able to complete a symptom assessment form on their own or with the help of a family member or interpreter

Exclusion Criteria:

* already receiving care from the Pain and Symptom Management/Palliative Care team