cyrilzakka/clinical-trials huggingface dataset:
A Clinical Trial of CoFactor Formulations and Leucovorin Administered Intravenously in Healthy, Adult Subjects.

The purpose of this study is to determine the safety and tolerability of CoFactor in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Males and Females age 18-65 inclusive at screening.
* Subject has to agree to practice abstinence or medically accepted contraception and not to participate in sperm donation or in vitro fertilization.
* Body Mass Index in the range of 18 to 30 kg/m2 and body weight of 45 to 95 kg.
* Subject must be healthy as determined by the investigator on the basis of screening evaluations.
* Subject must be nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must be able to abstain from smoking during the in-clinic stay.

Exclusion Criteria:

* Presence of clinically significant illness within 21 days prior to dosing, viral or bacterial infection, or documented drug allergies that may affect subject's safety during the study.
* Laboratory or clinical evidence suggestive of disease.
* Clinically significant or predisposing disorder that may interfere with the absorption, distribution, metabolism and/or excretion of drugs.
* History of drug abuse within 1 year of dosing and/or admitted alcohol abuse or history of alcohol use that may interfere with the ability to comply.
* Pregnant, lactating, or positive pregnancy test.
* Clinically significant electrocardiogram abnormalities.
* History of positive test for hepatitis B or C, or HIV.
* Positive findings of urine narcotic screen.
* History of drug allergy.
Does Gender Matter? Patient Preference in an Italian Osteopathic Clinical Setting

This study evaluates patients preference for the gender of their osteopath. All patients referring to an Italian private osteopathic clinic will receive a proper questionnaire before knowing the gender of their designed osteopath.

Several previous studies have shown that clinical contextual factors, such as patients preferences, play an important role in the patient-physical relationship, with resulting consequences on clinical outcomes.

The interaction between the gender of both patient and physician is often impacted by existing stereotypes.

Patient preference for specific physician gender has been investigated in scientific literature.

However the are no studies that analyzed the role of gender in osteopathic medicine.

Eligibility Criteria:
Inclusion Criteria: first visit at the osteopathic clinic (Centro di Medicina Osteopatica) Milan

Exclusion Criteria: non-Italian speaking
Multi-Center Pilot Study of Cutera truSculpt Device

Exploratory study to evaluate the safety, efficacy and ergonomics of Cutera truSculpt device.

This study will evaluate the safety, efficacy and ergonomics of Cutera truSculpt device.

Eligibility Criteria:
Inclusion Criteria:

* 1. Subject must be able to read, understand and sign the Informed Consent Form.

  2. Female or Male, 18 to 65 years of age (inclusive). 3. Subject has visible fat bulges in the area to be treated. 4. Non-smoking for at least 6 months and willing to refrain from smoking for the duration of the study.

  5. Subject must agree to not undergo any other procedure(s) in the treatment region during the study period.

  6. Subject must adhere to the follow-up schedule and study instructions. 7. Subject must adhere to the same diet and/or exercise routine throughout the study, and agree to maintain the same weight throughout the study.

  8. Willing to have photographs taken of the treatment area and agree to use of photographs for presentation, (educational and/or marketing), publications, and any additional marketing purposes.

  9. For female subjects: not pregnant or lactating and is either post-menopausal, surgically sterilized, or using a medically acceptable form of birth control prior to enrollment and during the entire course of the study.

Exclusion Criteria:

1. Participation in a clinical trial of another device or drug within 1 month of study participation, or during the study period.
2. Any type of prior cosmetic treatment to the target area within 6 months of study participation.
3. Any prior invasive cosmetic surgery to the target area, such as liposuction.
4. Has a pacemaker, internal defibrillator, implantable cardioverter-defibrillator, nerve stimulator implant, cochlear implant or any other electronically, magnetically or mechanically activated implant.
5. Has metal implant(s) within the body, such as artificial heart valves.
6. Significant uncontrolled concurrent illness that in the opinion of the Investigator would make the subject unsuitable for inclusion.
7. History of any disease or condition that could impair wound healing.
8. History of keloid formation, hypertrophic scarring or abnormal/delayed wound healing.
9. Skin abnormality in the treatment area that in the opinion of the Investigator would make the subject unsuitable for inclusion.
10. Currently undergoing systemic chemotherapy or radiation treatment for cancer, or history of treatment in the target area within 3 months of study participation.
11. Allergy or sensitivity to Tegaderm.
12. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study or a condition that would compromise the subject's ability to comply with the study requirements.
Antipsoriatic Effect of a Topical Formulation for the Treatment of Psoriasis Vulgaris

The current most important topical treatments for psoriasis are vitamin D3 analogues and/or corticosteroids. The possibility of another effective treatment for psoriasis could be based on the immunosuppressive efficacy of selective blockers of a lymphocyte potassium channel.

The aim of the clinical trial is to evaluate the safety, tolerability and anti-psoriatic efficacy of topical SPS4251 formulations in comparison to placebo and to a marketed topical Vitamin-D analogue ointment in a psoriasis plaque test.


Eligibility Criteria:
Inclusion Criteria:

* men aged 18 years or older
* subjects with mild to moderate psoriasis vulgaris in a chronic stable phase
* subject with up to three stable plaques with an area sufficient for five treatment fields
* Plaques to be treated should have a comparable thickness of the Echo Lucent Band of at least 200 µm

Exclusion Criteria:

* Subjects with guttate psoriasis, punctate psoriasis, erythrodermic psoriasis, psoriatic arthropathy and pustular psoriasis
* Local treatment with antipsoriatics in the 4 weeks preceding and/or during the trial, and any topical antipsoriatic treatment on the plaques to be treated in this trial in the 8 weeks before first treatment and/or during the trial
* Systemic treatment with antipsoriatics e.g. corticosteroids, cytostatics, retinoids in the three months before first treatment and during the trial;
* Treatment with systemic medications or medications acting locally which might have countered or influenced the trial aim
* Contraindications according to summary of product characteristics of Daivonex® Ointment;
* UV-therapy within four weeks before first treatment and during the trial
* Symptoms of a clinically significant illness that may influence the outcome of the trial in the four weeks before baseline visit and during the trial
* Any history of cardiovascular disease
* Any evidence of ECG abnormality on screening ECG
* Close affiliation with the Investigator (e.g. a close relative) or persons working at bioskin GmbH or subject is an employee of the Sponsor;
* Subject is institutionalized because of legal or regulatory order.
Safety and Immunogenicity Study of Group B Meningococcal Vaccine to Prevent Meningitis.

The purpose of this study is to determine if the vaccine called Group B Meningococcal 44/76 MOS NOMV 5D Vaccine is safe and free from side effects and if it will protect people from meningitis.

This study will vaccinate three groups of people. In the first 2 groups, the study will be double-blinded. This means that neither the volunteer or the medical team will know which formulation of the vaccine was administered. The third group of volunteers and the medical team will know that they are receiving the higher dose of the vaccine.

Meningococcal disease is a contagious bacterial disease caused by Neisseria meningitidis that can kill children and young adults very quickly. Meningococci are divided into distinct sergroups based on their polysaccharide outer capsule, which is the usual target antigen for vaccines. Serogroup A is the main cause of epidemics in Africa and in the United States, sergroups B, C and Y predominate. In the United States, no vaccine is yet available to offer protection against serogroup B which currently accounts for 32% of all meningococcal disease in the United States.

This study serves as a proof of concept for our new NOMV Group B single strain monovalent vaccine model which is obtained from a genetically modified parent. If successful we plan to develop a multivalent Group B vaccine for routine use for military recruits at the beginning of basic training, for college students, particularly those who live in dormitories, and for use by travelers to countries recognized as having hyperendemic disease.

Eligibility Criteria:
Inclusion Criteria:

* Healthy military or civilian males or non-pregnant, non-lactating females
* Age 18-45
* Give informed consent and understand risk and benefit of study
* Understands and willing to comply with all protocol procedures and time commitment
* FEMALES only: surgically sterilized or received a negative pregnancy test on day of first injection AND agrees to practice adequate birth control, if necessary, for the next 7 months after first vaccination.

Exclusion Criteria:

* Currently has or has had a history of significant organ/system disease
* History of allergy to any vaccine
* Allergy to component of vaccine such as aluminum hydroxide
* Presence of significant unexplained laboratory abnormality
* HIV sero-positive or any other immunosuppressive state
* Positive test for HBsAg, or hepatitis C
* Ongoing drug abuse/dependence
* Received any live vaccine, experimental products or immunosuppressive therapy in the last 28 days or inactivated vaccine in the past 14 days, or received parenteral immunoglobulin or blood products within the past 3 months
* Intention to leave study area for an extended period of time during the study
* Females: positive urine pregnancy test prior to vaccination
GARDIAN, Gadovist in Routine Diagnostic Magnetic Resonance Imaging Administration in Non-selected Patients

Prospective, non-interventional, multi-center study. The observation period for each subject covers the treatment period with Gadovist®. For each patient, the treating physician or nurse documents demographics, medical data, safety parameters and treatment signs and symptoms at the visit. Patients with severe renal impairment will be followed-up after 3 month by phone call from the investigator if in line with routine practice. Data audit/monitoring by source data verification will be done in a subset of sites and patients

Evaluate the safety and tolerability of Gadovist in patients requiring contrast-enhanced MRI.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing contrast enhanced Magnetic Resonance Imaging with Gadobutrol (Gadovist).

Exclusion Criteria:

* There are no other exclusion criteria beyond the contraindications contained in the Summary of Product Characteristics (hypersensitivity to the active substance or to any of the excipients) and the warnings.
Phase II Clinical Trial of De-Intensified Therapy in Human Papilloma Virus (HPV) Associated Oropharyngeal Squamous Cell Carcinoma

HPV-associated Oropharyngeal Squamous Cell Carcinoma (OPSCC) is a type of cancer that affects parts of the throat, like the tonsils and the base of the tongue. The treatments for OPSCC, which may include surgery, radiation, and chemotherapy, often cause serious side effects, such as loss of taste, dry mouth, and long-term problems with swallowing. These side effects can lower patients' quality of life and make it difficult for them to eat and speak normally.

This study aims to explore whether using lower doses of radiation after surgery can help improve long-term swallowing function in patients with HPV-positive OPSCC. By doing this, the study team hopes to reduce treatment-related side effects while maintaining good cancer control.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed or suspected HPV associated squamous cell carcinoma of the oropharynx.
* p16 immunohistochemistry is the surrogate marker for HPV positivity and will be scored as positive if there is strong and diffuse nuclear and cytoplasmic staining present in greater than 70% of the tumor specimen. (A negative result excludes the patient from the trial)
* In the case of equivocal p16, High Risk HPV (HR HPV), In-Situ Hybridization (ISH) / Polymerase Chain Reaction (PCR) may be performed to determine HPV positivity
* AJCC TNM 7th edition stage T1-T3, N0-N2b (or AJCC TNM 8th edition stage T1-T3 N0-N1) disease.
* Staging will be based on cross sectional imaging investigations and clinical exam.
* Patients who initially have an unknown primary but subsequently have a primary site identified on pathology after surgical resection may be included in the study.
* Multidisciplinary team decision to treat with primary transoral resection and neck dissection.
* Patients considered fit for surgery and adjuvant therapy.
* Aged 18 or over.
* Written informed consent provided.

Exclusion Criteria:

* HPV negative squamous cell carcinomas of the head and neck
* T4 and/or T1-T3 tumors where transoral surgery is considered not feasible or there is a high likelihood of positive margins.
* AJCC TNM 7th edition N2c-N3 nodal disease (or AJCC TNM 8th edition N2-N3 nodal disease) or high likelihood of gross extranodal extension.
* Patients for whom transoral surgery and neck dissection is not considered the primary treatment modality.
* Distant metastatic disease as determined by routine pre-operative staging radiological investigations e.g. CT thorax and upper abdomen or PET CT.
* Women who are pregnant or breastfeeding
* Prior history of radiation to head and neck
The Videolaryngoscopy Versus Direct Laringoscopy for Residents Intubation Study

The usual intubation technique in the operating room is based on direct laryngoscopy, using a standard Macintosh laryngoscope. However, this skill is not easy to acquire and requires adecuate training. Videolaryngoscopes are becoming a widely accepted airway management technique. because offer better view of the glottis and are easy to use. In addition, indirect laryngoscopes are useful for tracheal intubation by novice operators because of the feedback that supervisors can offer during intubation.

The goal of this clinical trial is to learn which intubation technique performed by residents of anesthesia in the operating room is better.

The main questions it aims to answer are:

* Which intubation technique is more effective for achieving first-attempt intubation?
* Which intubation technique results in fewer complications? Researchers will compare both intubation techniques performed by anesthesia residents in the operating room in adult anesthesia cases.

The study will randomize, by means of a computer-generated randomization, approximately 1008 adults in two groups: Conventional group (Laryngoscope with Macintosh Blade) and Videolaryngoscope group (Mac-Style Blade) to be intubated in the operating room by an anesthesia resident.

Success rate of the selected technique (first attempt), overall success rate, number of attempts, complications, and duration of insertion for technique will be noted.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years old
* Patients who need to be tracheal intubated for a surgical intervention in the surgical area.
* Intubation performed by an anesthesia resident.

Exclusion Criteria:

* Need for tracheal intubation with a device other than videolaryngoscopy or direct laryngoscopy (fiberoptic bronchoscope, tracheostomy...).
* Context of a Difficult Airway Management.
* Refusal of the patient
Strategy for Prompt and Effective Thoracentesis in the Emergency Department

The SPEEDTAP-trial is a prospective, randomised, investigator-initiated, multicenter, clinical superior trial investigating two thoracentesis methods in four emergency departments (ED) in Central Denmark Region. Patients are randomised to either manual fluid removal in the ED or passively fluid drainage using gravity in the radiology department (standard of care). Primary outcome: time from clinical indication to complete drainage and 188 patients will be included. Key secondary outcomes include length of stay, ED admission to ED discharge and safety end-points.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years admitted to the ED
* Pleural effusion detected by any imaging modality (e.g., bedside ultrasound, chest x-ray, computed tomography)
* Clinically justified need for thoracentesis ( symptomatic relief and/or define the etiology of the effusion
* Without contraindication for thoracentesis in the emergency department (e.g., anticoagulant treatment)

Exclusion Criteria:

* Life-threatening respiratory distress
* Not able to give consent
* Previous pleurodesis
* Effusion does not appear free-flowing due to septations or loculations / suspected empyema
* Prior enrollment in the trial
* If randomization is not possible because decision to insert a pigtail catheter is made in the radiology department
Effect of CPAP Treatment on the Elderly With Mild to Moderate Sleep Apnea

Objective: To analyze the impact of CPAP treatment on cognitive, clinical and quality of life domains in patients over 70 years of age with mild-to-moderate OSA

Primary Outcome: Epworth scale and QSQ domains

Secondary Outcomes: Neurocognitive variables and CPAP adherence


Eligibility Criteria:
Inclusion Criteria:

* Age equal or greater than 70 years of both sexes
* Patients with sleep study results with AHI ≥ 15 and \< 30

Exclusion Criteria:

* Alternative diagnoses of other non-respiratory sleep disorders that are also cause of pathological somnolence (eg, sdr restless legs, narcolepsy, etc.)
* Don't sign informed consent
* Acute or chronic respiratory insufficiency requiring home oxygen therapy
* Patients with Obesity Hypoventilation Syndrome
* Diagnosis of neuro-psychiatric diseases with the exception of anxiety - depression or diagnosis of dementia.
* Diseases of any origin in the acute phase
* Heart failure or recent stroke (less than 3 months).
* Central SAHS (more than 50% of the registry with central apneas or Cheyne-Stokes breathing)
* Pre-treatment with CPAP
* Inability to perform the diagnostic study of sleep due to the patient's condition
* Hipersomniaincapacitante (Epworth≥18) with no known or most likely cause related to SAHS
A Study to Assess the Effect of Maintenance Treatment With Rituximab Versus No Treatment in Participants With Progressive B-Cell Chronic Lymphocytic Leukemia (CLL)

This study will assess the effect of maintenance treatment with rituximab in comparison with observation period (no treatment), in participants with progressive B-cell CLL who have had previous first-line induction treatment with rituximab, cladribine and cyclophosphamide (RCC regimen). After 6 months of RCC induction therapy, participants will be randomized either to receive maintenance treatment with rituximab or to receive no treatment (observation only) for 96 weeks. Participants completing maintenance/observation period will be followed-up for approximately 3 years.


Eligibility Criteria:
Inclusion Criteria:

* Immunologically confirmed diagnosis of B-cell CLL
* Rai stage I-IV disease with evidence of progression
* No previous chemotherapy, radiotherapy, or immunotherapy for B-cell CLL
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

Exclusion Criteria:

* Active secondary malignancy or transformation to aggressive lymphoma
* Medical condition requiring chronic use of oral corticosteroids at a dose of 1 mg/kg or 60 mg/m\^2 over 2 weeks
* Prior treatment with interferon, rituximab or another monoclonal antibody, immunosuppressive treatment or radiotherapy before inclusion to the study
* History of other malignancies within 2 years before study entry, except for dequately treated carcinoma in situ of the cervix; basal or squamous cell skin cancer; low grade, early stage localized prostate cancer treated surgically with curative intent; good prognosis ductal carcinoma in situ (DCIS) of the breast treated with lumpectomy alone with curative intent
Effects of Resistance-band Training and Creatine Supplementation Strategies in Healthy Older Adults

The primary purpose is to compare the effects of creatine supplementation (bolus ingestion of 5 grams vs. 3 grams) during 16 weeks of resistance-band training on measures of body composition (i.e., whole-body lean tissue mass, total body water), arm and leg muscle thickness (growth), muscle performance (i.e., power, strength, endurance) and functional ability (i.e., walking speed, balance).

A secondary purpose of this research is to examine the effects of bolus ingestion of creatine (5 grams) compared to intermittent ingestion of creatine (2 x 2.5 grams) during 16 weeks of resistance-band training on measures of body composition (i.e., whole-body lean tissue mass, total body water), arm and leg muscle thickness (growth), muscle performance (i.e., power, strength, endurance) and functional ability (i.e., walking speed, balance).

Resistance-band training is safe, conveient, easy-to-use, eliminates potential barriers to exercise participation (i.e., lack of transportation to and from commercial training facilities) and results in high exercise compliance and adherence. Further, resistance-band training results in similar improvements in muscle performance and functional ability compared to traditional resistance-type training using free-weights and machines.

Creatine is a naturally occurring nitrogen-containing compound produced in the body in the liver and brain and can also be found in food products such as red meat and seafood or through commercially available manufactured creatine products.

Evidence-based research shows that creatine supplementation, when ingested during a resistance exercise training program, improves measures of lean mass and muscle growth, muscle performance and functional ability. However, the optimal creatine supplementation protocol to achieve these benefits is unknown.

Eligibility Criteria:
Inclusion Criteria:

* if you are 50 years of age and older
* if you have not been performing more than 1 resistance training session per week for the past 6 weeks or more.

Exclusion Criteria:

* if you have taken creatine supplements within 30 days prior to the start of the study
* if you have pre-existing allergies to the placebo (corn-starch maltodextrin).