cyrilzakka/clinical-trials huggingface dataset:
A Phase I Clinical Trial of an HPV Therapeutic Vaccine

This study will consist of 300 women aged 18-50 years. The study will show that a new therapeutic human papillomavirus (HPV) vaccine designed to regress a precancerous condition called high-grade squamous intraepithelial neoplasia (HSIL)is safe. HPV is known to cause cervical, vaginal, oral, and anal cancers. This novel vaccine will consist of a synthetically made fragment of HPV protein called E6 and yeast extract called Candin®. Previous studies have revealed that immune response to E6 is important in fighting HPV. We also know that injecting Candin has anti-HPV effect since it has been used to treat common warts which are caused by different types of HPV. The current standard treatment for HSIL is loop electrical excision procedure (LEEP). The immune system is the part of the body that fights infection and cancer. This research study will also examine the immune response to the vaccine and its effectiveness in regressing HSIL. Volunteers would be eligible to enroll in the study if they have had a recent Papanicolaou (Pap) smear result indicating HSIL or "Cannot rule out HSIL", and if they meet the inclusion/exclusion criteria. Subjects will be eligible to receive vaccinations if biopsy confirms HSIL. A series of four vaccinations will be given roughly 3 weeks apart, and LEEP will be performed at the end of the study approximately 12 weeks after the last vaccination.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18-50 years
* Had recent Pap smear result consistent with HSIL or "cannot rule out HSIL" or HSIL on biopsy
* Untreated for HSIL or "Cannot rule out HSIL"
* Able to provide informed consent
* Certain physical exam and blood component parameters within acceptable ranges
* Willingness and able to comply with the requirements of the protocol with a good command of the English language

Exclusion Criteria:

* History of disease or treatment causing immunosuppression (e.g., cancer, HIV, organ transplant, autoimmune disease)
* Being pregnant or attempting to be pregnant within the period of enrollment
* Breast feeding or planning to breast feed within the period of enrollment
* Allergy to Candida antigen
* History of severe asthma requiring emergency room visit or hospitalization
* Current use of beta-blocker medication (may not respond to epinephrine in case of anaphylaxis)
* If in the opinion of the Principal Investigator or other Investigators, it is not in the best interest of the patient to enter this study
GCPGC in Chemotherapy-induced Neutropenia

This study is adaptive design and it consists of stage I and stage II.

Stage I is multi-center, parallel-group, single-blind, phase II study to determine the adequate dose of GCPGC in chemotherapy-induced neutropenia. 2 Different doses of GCPGC will be investigated in a total of 60 Breast cancer patients who are receiving chemotherapy.

Stage II is multi-center, parallel-group, double-blind,phase III study to evaluate the efficacy and safety of once per cycle GCPGC in chemotherapy-induced neutropenia compared to Neulasta (pegfilgrastim). A total of 120 patients receiving chemotherapy will participate into this phase.

GCPGC ia a solution for containing pegfilgrastim. Pegfilgrastim is a covalent conjugate of recombinant human granulocyte colony-stimulating factor (G-CSF) with a polyethylene glycol (PEG) which has long half life compared to filgrastim, resulting in dosing advantage.

Eligibility Criteria:
Inclusion Criteria:

* women(≥ 18 years old) diagnosed with breast cancer who are receiving chemotherapy inducing neutropenia
* body weight of 45kg and more
* ECOG performance status 2 and less
* ANC ≥1,500mm3 and Platelet ≥100,000/mm3
* life expectancy of 3 months and more
* given written informed consent

Exclusion Criteria:

* had previous exposure to pegfilgrastim or filgrastim
* had received systemic antibiotics within 72hrs of chemotherapy
* prior total cumulative lifetime exposure to doxorubicin more than 240 mg/m or epirubicin more than 600 mg/m
Cardiopulmonary Rehabilitation in Post-acute COVID-19 Syndrome

In 2022, though the optimized acute medical treatment of COVID-19 was determined, patients often experience the sequelae (also known as post-acute COVID-19 syndrome, the patients might develop cough, breathlessness, fatigue, weakness, impaired activities of daily livings etc.). Until now, there is no consensus for post-acute COVID-19 syndrome management. Previously, the cardiopulmonary rehabilitation revealed significant benefits in heart failure or chronic obstructive pulmonary disease. The aims of the study are demonstrating the benefits and safety of cardiopulmonary rehabilitations in patients previously admitted to hospital because of COVID-19 with sequelae.

PURPOSE: To demonstrate the benefits and safety of cardiopulmonary rehabilitations in patients previously admitted to hospital because of COVID-19 with sequelae.

METHODS: The participants will be divided into two groups: one with cardiopulmonary rehabilitations programs under the supervision of therapists 3 times a week, 12 weeks in total with lifestyle modification (experimental group); and the other with lifestyle modification and health education (active-controlled group). Before and after the interventions, several endpoints in interested are performed by the physicians or the research assistants, including cardiopulmonary exercise training (CPET), 6-minute-walk-test (6MWT), pulmonary function tests (PFT), and quality of life (QoL, we plan to use SF-36) questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* be willing and able to provide written informed consent and comply with all procedures required by the protocol
* be 20 - 80 years of age at the time of signing the Informed Consent Form
* diagnosed with COVID-19 with PCR and admitted with at least moderate COVID-19 disease (with clinical symptoms or imaging evidence of low respiratory tract involvement)
* diagnosed with COVID-19 for over 4 weeks but less than 2 years with fatigue, shortness of breath, cough, weakness, or impairments of activities of daily life
* able to cooperate with the rehabilitation programs and cycling

Exclusion Criteria:

* Patients under 20-year-old or over 80-year-old, pregnant, prisoners
* Patients without national health insurance in Taiwan
* The patient cannot follow instructions or cycling
Cutaneous Effects of Cryogen Spray Cooling

Cryogen Spray Cooling spurt is applied to the skin surface immediately before laser exposure. As liquid cryogen rapidly evaporates, the superficial skin temperature is reduced as a result of supplying the latent heat of vaporization. Tetrafluoroethane, an environmentally compatible, non-toxic, non-flammable freon substitute, has been demonstrated in multiple studies to be a safe and effective cooling agent and is the only cryogenic compound currently approved for dermatologic use by the Food and Drug Administration.

The researcher can use laser treatment in combination with Cryogen Spray Cooling. The specific aim of this study is to characterize the clinical cutaneous effects of varying spurt durations and spurt delivery patterns that spurt durations of 100 ms or less will result in a very low incidence (less than 2%) of clinical skin effects (redness, blistering, local skin allergic reaction or skin discoloration) in any skin type.

Researchers can use Cryogen Spray Cooling to protect the skin epidermis during laser therapy to decrease treatment pain, allow safe treatment of darker skin types, and safe use of high laser fluences. Cryogen Spray Cooling with Tetrafluoroethane has been incorporated into many Food and Drug Administration approved, commercially available laser devices currently used for treatment of vascular lesions, hair removal and non-ablative skin rejuvenation.

Eligibility Criteria:
Inclusion Criteria:

* Adult 18 years and older

Exclusion Criteria:

* Age \<18
* History of cold sensitivity
* Inflammatory rash on the test site
Cyrotherapy vs. APC in GAVE

To see if either method of treatment for Watermelon Stomach shows better results

Watermelon stomach (WS) is endoscopically recognized by characteristic stripes of angioectasias involving primarily the antrum, and causes transfusion-dependent anemia in the majority of patients. Current endoscopic treatment options, including argon plasma coagulation (APC) Endoscopic cryotherapy is a novel technique that has the potential to safely and more effectively treat WS by virtue of its mechanism of injury and mode of application.

Eligibility Criteria:
Inclusion Criteria:

1. Confirmed WS at endoscopy that is associated with significant anemia (Hb \< 10 g/dl) and/or overt bleeding (melena, hematochezia or hematemesis) and/or blood transfusions within the past 6 months
2. Able to give informed consent
3. Age \> 18 years

Exclusion Criteria:

1. Endoscopic or histological findings inconsistent with WS
2. Known coagulopathy (INR \> 2), severe thrombocytopenia (platelet count \< 50,000), or bleeding diathesis
3. Endoscopic treatment of WS within the past month
4. Unable or unwilling to give informed consent.
Ziconotide as First-Line IDT

The primary objective of this study is to prospectively examine outcomes in 12 patients using ziconotide Intrathecal Drug Therapy(IDT) as first-line monotherapy with the use of an algorithm of slow titration for dosing. The use of Prialt has demonstrated fewer and less serious associated adverse effects as compared to IDT morphine, especially when titrated slowly. We will use an average Numerical Rating Scale as our primary outcome and the Oswestry Disability Index(ODI), Beck Depression Inventory (BDI), Pain Catastrophizing Scale (PCS), Clinical Global Impression of Change Scale including binary satisfaction measures(CGIC), Lawton-Brody Instrumental Activities of Daily Living(IADL) and Short Form-36 as secondary outcome measures.


Eligibility Criteria:
Inclusion Criteria:

1. Must be eligible for implantation of an intrathecal analgesia programmable pump system using ziconotide IT.
2. Must be 18 years of age or older for all points of data collection.
3. Must be diagnosed with neuropathic pain secondary to a clear etiology. Acceptable etiologies including but not limited to diabetic neuropathy, small fiber neuropathy, and post herpetic neuropathy.

Exclusion Criteria:

1. Must not have or been previously implanted with a programmable pump system.
2. Untreated mental illness including depression or anxiety determined by preoperative psychological evaluation.
3. Active substance abuse determined by preoperative urine drug screen.
4. Unwillingness to decrease oral medications at screening.
5. Any prior use of intrathecal analgesia besides trialing
Filling Bone Erosions: a Longitudinal Multicentric HR-pQCT Study of Subcutaneous Tocilizumab in Rheumatoid Arthritis

Rheumatoid arthritis (RA) is a chronic inflammatory disease mediated by the production of several cytokines, which leads to the destruction of bone and cartilage tissue in multiple joints and to bone loss. Conventional radiographs (CR) are considered as the gold standard for diagnosis and follow up of joint changes in RA. But this method has low sensitivity to detect early erosive changes and is unable to evaluate periarticular bone loss.

High Resolution peripheral QCT (HRpQCT) enables the detection of erosions less than 0.5 mm in width or depth at metacarpo-phalangeal (MCP) joints. Using 3-D high resolution analysis of cortical bone erosions, this one is also able to evaluate the volumes of erosion and the evolution under treatments IL6 (6- interleukin) plays a major role in inflammatory process and bone damages related to RA. Tocilizumab (TCZ) is a humanized anti-IL-6R monoclonal antibody, developed and investigated in several clinical trials in RA. This biotherapy, in association with methotrexate (MTX) or given in monotherapy, is efficient in RA with inadequate response to MTX or anti-TNF b (tumor necrosis factor). TCZ reduces dramatically systemic inflammation, structural progression and improves clinical symptoms and quality of life.

Tocilizumab may help reducing bone erosions, periarticular osteopenia and systemic bone loss.


Eligibility Criteria:
Inclusion Criteria:

* Active RA, \< 10 years disease duration, diagnosed according to the ACR-EULAR 2010 classification criteria
* DAS 28 superior or equal to 3.2 despite DMARD or biological treatment (other than tocilizumab)
* Superior or equal to one joint erosion at the right or left MCP 2, 3 on X-rays
* Oral corticosteroid ≤ 10 mg/day prednisone or equivalent stable for at least one month
* RA patients eligible to subcutaneous Tocilizumab monotherapy

Exclusion Criteria:

* Treatment with zoledronic acid or denosumab (less than one year)

  * Intra-articular injection of corticosteroids at the MCP in the previous three months
  * Tocilizumab contra-indications in accordance with SPC (Summary of Product Characteristics) :Hypersensitivity to the active substance or to any of the excipients Active, severe infections including active tuberculosis Diverticulitis Active hepatic disease and hepatic Impairment including viral hepatitis Elevated Alanine Aminotransferase or Aspartate Aminotransferase \>5×ULN Absolute neutrophil count \< 0.5 × 10 exp 9 /L Platelet count \< 50×10 exp 3 /μL,

General:

* Absence of informed consent
* Prior or planned joint surgery of the hands which might impact the interpretation of imaging assessments.
Recruitment Strategies Comparing Different Strategies in Sleep Apnea and Prediabetes

Recruitment strategies comparing different strategies.

Patients with prediabetes and moderate-to-severe Obstructive Sleep Apnea (OSA). To determine the recruitment yields from electronic medical record (EMR) vs the general community. To assess the adherence to positive airway pressure (PAP) therapy among patients with prediabetes and moderate-to-severe OSA.

Eligibility Criteria:
Inclusion Criteria:

* Prediabetes: A1c value of 6.0-6.4% and fasting glucose of 100-125 mg/dl
* Moderate-to-severe OSA \[4% oxygen desaturation index (ODI) ≥ 20/h\]
* Ability to provide informed consent
* Able to comply with all study procedures and be available for the study duration
* Availability of smart phone

Exclusion Criteria:

* BMI \< 28 or ≥ 38 kg/m2
* Type 1 or Type 2 diabetes mellitus
* Pregnancy
* Use of glucose-lowering or weight loss medications (e.g., metformin, orlistat, phentermine)
* Prior or anticipated bariatric surgery
* Current use of PAP or oral appliance therapy for OSA
* Commercial driver
* Report of a motor vehicle accident or near-miss due to sleepiness within 2 years
* Epworth Sleepiness Scale score10 \> 18
* Current (prevalent) use of oral corticosteroids (within 1 month)
* Participation in a concurrent clinical trial
* Unstable medical conditions: uncontrolled angina and/or congestive heart failure, uncontrolled blood pressure or resistant hypertension \[BP ≥ 160/100 among those with hypertension, requiring 3 or more meds\], severe chronic obstructive pulmonary disease, cancer, or active psychiatric disease
* Other sleep disorders (e.g., circadian rhythm disorder, working night or rotation shift, short sleep duration based on self-reported habitual sleep patterns \< 5 hrs/night)
* Use of supplemental oxygen during wakefulness or sleep
* Central sleep apnea (central apnea index ≥ 5/h) or Cheyne-Stokes respiration (\> 10 minutes of continues period breathing) on the screening home sleep test Resting awake SpO2 \< 90%
* Chronic opiate use.
* Use of illicit drug / marijuana use more than once per week
* Difficulty understanding or speaking English
* Anything that, in the opinion of the site investigator, would place the participant at increased risk or preclude a participant's ability to adhere to study protocols or complete the study
The Tilburg Vasospasm Study

In a prospective randomized controlled trial, the investigators aim to assess whether external lumbar drainage (ELD) of CSF is safe and reduces delayed cerebral ischemia and its sequelae in patients with an aneurysmal subarachnoid hemorrhage.

Delayed cerebral ischemia (DCI) is a frequent complication after an aneurysmal subarachnoid hemorrhage (SAH). Its pathophysiological mechanism remains unclear but a role for cerebral vasospasm and the presence of blood in the arachnoid space is likely. A wash out of blood and blood breakdown products in the cerebrospinal fluid (CSF) could reduce the incidence of vasospasm and DCI.

We aim to assess whether external lumbar drainage (ELD) of CSF is safe and reduces secondary ischemia and its sequelae.

Eligibility Criteria:
Inclusion Criteria:

* spontaneous subarachnoid hemorrhage (SAH) with aneurysmal pattern graded as a Fisher grade III or higher on cerebral CT-scan.
* CSF drainage by external lumbar catheter can start within 96 hours after the initial SAH
* the drainage can start prior to the treatment of the ruptured aneurysm
* informed consent is signed by the patient or his representative

Exclusion Criteria:

* spontaneous SAH with aneurysmal pattern graded as a Fisher grade I or II on CT and perimesencephalic hemorrhages
* traumatic SAH
* symptomatic hydrocephalus on admission necessitating drainage (EVD or ELD)
* the presence of a large intraventricular bloodclot in the third or fourth ventricle on CT
* the presence of a mass lesion with significant cerebral midline shift
* all patients whose neurological condition is too poor to allow clinical recognition of signs and symptoms of cerebral vasospasm. This includes all patients with a Hunt and Hess Grade V who failed to improve after initial resuscitation
* no informed consent
* mycotic aneurysms
Personalized Feedback Intervention to Reduce Risky Cannabis Use.

The purpose of this project is to determine whether participants who receive a personalized feedback report and educational materials about risky cannabis use will be less likely to report risky cannabis use at follow-up compared to participants who only received educational materials.

This project aims to reduce risky cannabis use among those with less severe cannabis use, most of whom will never seek formal treatment. All of the participants will receive educational material regarding risky cannabis use and its prevention. Half of the participants will also be assigned by chance to receive a personalized feedback report.

The investigators hypothesize that:

1. Participants who receive the full personalized feedback intervention will be less likely to report risky cannabis use at 3- and 6-month follow-ups compared to participants who receive educational materials only (Primary Hypothesis).
2. Participants who receive the full personalized feedback intervention will report greater reductions in their perceptions of how much others use cannabis at a 3-month follow-up compared to participants who receive educational materials only.
3. Reductions in perceptions of how much others use cannabis at 3-month follow-up will be positively associated with reduction in the participant's risky cannabis use at 6-month follow-up.

A 2-arm parallel group randomized controlled trial will be conducted to test these hypotheses with follow-ups occurring at 3 and 6 months after randomization. Online media advertisements will be used to recruit people currently using cannabis. The advertisements will be placed across Canada using locations found successful in previous trials to rapidly recruit participants (e.g. Google AdWords).

Eligibility Criteria:
Inclusion Criteria:

* Score of 4 or more on the Alcohol, Smoking, and Substance Involvement Screening Test, Cannabis subscale (ASSIST)

Exclusion Criteria:

* Being under 18 years of age
Neuroendocrine Neoplasms Methylation Based Classifier - The NEMESIs-study

Neuroendocrine neoplasms (NEN) are rare tumors that mainly occur in the gastrointestinal tract and the lungs. The currently available diagnostic and prognostic markers do not adequately represent the diversity of these tumors. Methylation analyzes of the tumor DNA represent a new, promising approach.

The aim of this project is therefore to improve the diagnostic and prognostic evaluation of neuroendocrine neoplasms by means of methylation analysis of the tumor DNA. On the one hand, existing tumor samples from the biobank of Basel University Hospital are evaluated, on the other hand, patients who are undergoing an operation will be prospectively inquired


Eligibility Criteria:
Inclusion Criteria:

* neuroendocrine tumor

Exclusion Criteria:

* insufficient amount or quality of neuroendocrine tumor sample
Fluticasone Furoate/GW642444 Inhalation Powder Long-Term Safety Study

The purpose of this study is to evaluate the long-term safety of fluticasone furoate/GW642444


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of asthma
* Reversibility FEV1 of twelve percent or greater and two hundred milliliters and greater approximately ten to forty minutes following two to four inhalations of albuterol
* FEV1 greater than or equal to fifty percent of predicted
* Currently using moderate to high dose inhaled corticosteroid therapy

Exclusion Criteria:

* History of life threatening asthma
* Respiratory infection or oral candidiasis
* Asthma exacerbation
* Uncontrolled disease or clinical abnormality
* Allergies
* Taking another investigational medication or prohibited medication
The Correlation Between The New Sepsis Scores - SOFA, Quick SOFA and Calibrated Automated Thrombogram Values

In total 200 subjects with diagnosis of sepsis, are planned for inclusion in this trial. After signing an informed consent a blood sample will be obtained from each participant. The investigators will measure the thrombin generation in plasma assessed by the calibrated automated thrombogram (CAT). Sequential Organ Failure Assessment score SOFA will be calculated. The relation between SOFA score and thrombin measurements will be determined.


Eligibility Criteria:
Inclusion Criteria:

* age above 18
* sepsis diagnosis

Exclusion Criteria:

* oncology patient.
* anticoagulant treatment
* pregnancy
Acetaminophen in Combination With N-Acetylcysteine (NAC) Versus Placebo in Treating Fever

The purpose of this study is to compare the efficacy of the an N-acetyl-p-aminophenol (APAP, also known as acetaminophen) and N-acetylcysteine (NAC) combination versus an APAP-placebo combination as an anti-pyretic agent.

N-acetyl-p-aminophenol (APAP), or more commonly known as acetaminophen in the United States, accounts for more overdose and overdose deaths in the United States and United Kingdom than any other pharmaceutical agent. If N-acetylcysteine (NAC) is given within 8 to 10 hours of APAP ingestion, it has been shown to prevent serious liver failure and death in the setting of overdoses. Therefore, it may be beneficial to administer APAP in combination with NAC routinely to reduce rates of liver failure and death. Because NAC's main role is to reduce the accumulation of APAP's toxic metabolites, the concomitant administration of NAC should have no impact on the efficacy of APAP as an antipyretic and analgesic. Thus, we propose a single-center, non-inferiority randomized control study comparing the efficacy of the APAP-NAC combination as compared to APAP-placebo as an anti-pyretic agent.

Eligibility Criteria:
Inclusion Criteria:

* adults aged 18 to 75 years old
* admitted to an inpatient unit at Columbia-Presbyterian Medical Center
* fever defined as an oral temperature of 38.5°C

Exclusion Criteria:

* if oral temperature cannot be obtained
* abnormal aminotransferase levels
* prior adverse reaction to acetaminophen or N-acetylcysteine