cyrilzakka/clinical-trials huggingface dataset:
A Bioequivalence Study of Norgestimate /Ethinyl Estradiol (NGM/EE) Tablets Manufactured at 2 Different Facilities

The purpose of this study is to establish the bioequivalence of the hormones norgestimate, norelgestromin, and ethinyl estradiol in norgestimate/ethinyl estradiol (NGM/EE) tablets, formulated by wet process compared with the same hormones in NGM/EE tablets, formulated by dry process, in healthy women.

This is a Phase 1, single-dose, open-label (a medical research study in which participants and researchers are told which treatments the participants are receiving, "unblinded"), randomized (the study medication is assigned by chance), single-center and a 2-way crossover (method used to switch participants from one study group to another in a clinical trial) study in healthy women. The study consists of 3 parts: Screening phase, Treatment phase and end-of-study or withdrawal. Treatment periods will be separated by a wash out period of at least 10 days. The duration of participation in the study for an individual participant will be approximately 7 weeks. All participants will be randomly assigned in a 1:1 ratio to 1 of 2 possible treatment sequences and receive both of the following treatments: 1 oral tablet formulated by wet process or dry process, whereas each tablet contains norgestimate 250 microgram (mcg) and ethinyl estradiol 35 mcg. The primary endpoint of the study will be assessment of pharmacokinetic parameters. Participants' safety will be monitored throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be either surgically sterile or of child-bearing potential and be practicing an effective non-hormonal method of birth control (for example, copper intrauterine device, double-barrier method, male partner sterilization) before entry and throughout the study
* If a woman of child-bearing potential, must have a negative serum beta-human chorionic gonadotropin (hCG) pregnancy test at screening; and a negative urine pregnancy test on Day -1 of the each treatment period
* Participants must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 3 months after the last dose
* Body mass index (BMI: weight \[kilogram {kg}\]/height\^2 \[meter {m}\]\^2) between 18.5 and 30 kg/m\^2 (inclusive), and body weight not less than 50 kilogram (kg) or higher than 90 kg (198 pounds)
* Participant must be a non-smoker

Exclusion Criteria:

* Participants have a levonorgestrel implant (for example, Norplant) in place or removed within the 30 days before admission to the study site
* Contraindications to combined hormonal contraceptives
* Participants who received medroxyprogesterone injection (for example, Depo Provera) within 6 months of admission to the study
* Use of any other hormonal contraceptive within 30 days of admission to the study site
* Participants with abnormal papanicolaou (Pap) smear or CytoRich test
Digital vs Conventional Impression in Capturing the Emergence Profile Around Maxillary Anterior Implant-supported Crowns

This study compares conventional impression and cast fabrication to direct/indirect digital scannig and 3D printed casts regarding their accuracy in replicating the peri-implant emergence profile of single implants in the maxillary anterior region (FDI #15-25).

Correct design of the peri-implant emergence profile (EP) is crucial for maintaining the health of the supracrestal complex and long-term success of the implant implant-prosthodontics. After its formation with a provisional restoration, its shape needs to be transferred to the final restoration via conventional elastomeric or digital (direct/indirect) impression taking.

Our aims are to investigate around maxillary anterior single implants in patients with thick gingival phenotype:

1. the accuracy of direct digital impression vs indirect digital impression vs conventional elastomeric impression in capturing the EP and implant position
2. the accuracy of 3D printed cast with conventional gingival mask vs conventional epoxy-resin cast with gingival mask in replicating the EP and implant position
3. the amount of soft tissue collapse at 0,2,10,20 minutes following the removal of the provisional restoration in case of direct EP scanning

Eligibility Criteria:
Inclusion Criteria:

* Adult above 18 yo
* No systematic deseases
* Good oral hygene (FMPS \< 25%)
* Stable occlusion
* Thick phenotype
* Single missing maxilary anterior (FDI #15-25 position) tooth replaced with osseointegrated bone level impant
* Correctly formed soft tissue with CAD/CAM temporary abutment for min. 3 months
* Neighbouring teeth in place and in good condition
* Patient voluntarily accepts and signs the patient leaflets for the trial

Exclusion Criteria:

* Active periodontitis
* Peri-implant inflammation
Omega-3-Acid Ethyl Esters 90 Soft Capsules for Lowering Very High Triglycerides

The trial was a double-blind, randomized, parallel-group study comparing Omega-3-Acid Ethyl Esters 90 Soft Capsules and placebo. The primary objective of the present study was to evaluate the efficacy and safety of Omega-3-Acid Ethyl Esters 90 Soft Capsules in subjects with severe hypertriglyceridemia (TGs ≥500 mg/dL but \<2000 mg/dL).


Eligibility Criteria:
Inclusion Criteria:

-1.At least 2 times of fasting serum TG concentrations≥500 mg/dL but\<2000 mg/dL at screening (2and 1 and 0 weeks before random assignment).

2.Two times qualified High Triglycerides Dietary Assessment Table at 2 and 0 weeks before random assignment according to the "prevention and treatment of dyslipidemia in Chinese adults Guide ".

Exclusion Criteria:

* 1.Unable to discontinue use of other omega-3 fatty acid-containing products, bile acid sequestrants, fibrates ,niacin or any supplement used to alter lipid metabolism throughout the entire study.

  2.Patients taking bile acid sequestrants, fibrate, niacin or any supplement used to alter lipid metabolism more than 6 weeks before entering the study dietary phase.

  3.Subjects consuming omega-3 fatty acid-containing products such as cod liver oil, or lipid-decreasing fibers at least 4 weeks before beginning the study.

  4.Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST)\>3 times the upper limit of normal.

  5.Serum creatinine \>176μmol/L. 6.Platelet counts\<60×109/L，hemoglobin \<100 g/L. 7.Poorly controlled hypertension(resting blood pressure ≥160 mm Hg systolic or ≥100 mm Hg diastolic) 8.Uncontrolled type II diabetes(fasting blood sugar \>11.1mmol/L). 9.Type II diabetes, nephrotic syndrome, hypothyroidism. 10.Atrial fibrillation. 11.History of pancreatitis and symptomatic gallstone disease, unless treated with cholecystectomy.

  12.History of cancer (other than basal cell carcinoma) in the past 2 years. 13.Allergy or intolerance to omega-3 fatty acids, omega-3-acid ethyl esters, or fish.

  14.History in the past 12 months of drug abuse or alcohol abuse (.14 drinks per week; 1 drink was equivalent to 12 oz beer, 5 oz wine, or 1.5 oz hard liquor) was also exclusionary.

  15.Exposure to any investigational product, within 30 days prior to Visit. 16.Presence of any other condition the Investigator believes would interfere the study.
Rhodiola Rosea for Mental and Physical Fatigue

The primary objective of this trial is to assess whether Rhodiola rosea improves fatigue when compared to placebo in nurses involved in shift work.


Eligibility Criteria:
Inclusion Criteria:

* Fourth year nursing students enrolled in NURS 495 (Nursing Practice)
* Participating in permanent overnight (between 11 pm and 7 am) or rotating shift work
* otherwise healthy
* consent to participate in the study

Exclusion Criteria:

* nurses aged 18 years or younger
* breastfeeding or pregnant women, as confirmed by a blood test
* female participants with child bearing potential not practicing a form of birth control throughout the trial
* presence of a primary medical condition associated with fatigue (e.g. cardiac, gastrointestinal, respiratory, renal, rheumatologic, or oncologic disease)
* presence of schizophrenia, bipolar disorder, dementia, eating disorders, insomnia or substance abuse
* presence of diabetes
* concurrent utilization of hypoglycaemic or agents for raising or lowering blood pressure
* known allergy or hypersensitivity to Rhodiola rosea or Sedum family extracts or pollen
* know allergy to microcrystalline cellulose or silicone dioxide
* concurrent utilization of stimulant drug such as methylphenidate (Ritalin), amphetamine (Dexedrine, Adderall), methamphetamine (Desoxyn) and pemoline (Cylert)
* concurrent utilization of other rhodiola or ginseng products (both fall in the same therapeutic category known as an "adaptogen")
* any significant medical condition
* any neurological or mental health condition
* taking medication that has central nervous system effects
* aged 55 years or older
* low blood pressure or history of significant dizziness
Effect Of Bioelectric Therapy On Sternal Instability In Patients With Median Sternotomy After Heart Valve Surgery

The aim of this study is to investigate the effect of bioelectric therapy on sternal instability in patients with median sternotomy after heart valve surgery.

Valvular heart disease constitutes a growing healthcare problem with a general prevalence of 2%-5% and a prevalence of 13% after the age of 75 years Heart valve surgery can be a lifesaving procedure for patients with severe symptomatic heart valve disease. Nevertheless, following the surgery, up to 27% of patients may require readmission within 30 days after discharge. Following heart valve surgery, some patients report anxiety and worries related to readmission and reoperations, postoperative complications, and deconditioning which may prevent or delay return to work and limit activities of daily living.Over the past 30 years, bone-growth stimulators have become a critical component in fracture care. They can be classified into four categories: direct-current (DC) devices, inductive coupling, noninvasive capacitive coupling, and low-intensity ultrasound. Microcurrent electrical stimulation ( MES) is the therapeutic use of constant (DC) and pulsed (interrupted) currents, where the stimulus amplitude is in the micro amperage (millionth of an ampere) range. MES is defined as those of less than 1 mA or 1000 μ, (MES \< 1 mA). This form of electrical stimulation tends to be applied at the suspensory or very low sensory level and they are not designed to stimulate muscle contraction. Generators that produce MES were originally called microcurrent electrical neuromuscular stimulators (MENS). However, the stimulation pathway is not the usual neural pathway, and they are not designed to stimulate muscle contraction. Consequently, this type of generator was subsequently referred to as a microcurrent electrical stimulator (MES). The use of MES may be an adjunctive modality in the treatment of fractures or injury sites, especially fractures prone to nonunion. Fracture healing may be accelerated by passing a monophasic current through the fracture site. Getting the current into the bony area without an invasive technique is difficult.forty subjects will be allocated to two groups; one group will receive micro-current therapy and routine cardiac rehabilitation program both for four weeks and the control group will receive the cardiac rehabilitation program only for four weeks.

Eligibility Criteria:
Inclusion Criteria:

1. there age between 40 and 50 years,
2. hemodynamic stability
3. BMI from 25 to 29.9 kg/m2,
4. they will have acute sternal instability.

Exclusion Criteria:

1. previous thoracic surgery
2. elective and urgent coronary artery bypass surgery
3. respiratory insufficiency after surgery manifesting hypoxemia with partial pressure of oxygen in arterial blood \<60 mmHg
4. renal insufficiency with serum creatinine ≥1.8 mg/dl after surgery
5. low cardiac output syndrome with ST segment elevation in multiple electrocardiogram leads, cardiac arrhythmias, or hypotension, according to the American College of Cardiology Foundation and American Heart Association
Atomoxetine Hydrochloride Versus Placebo in Taiwanese Children and Adolescents With ADHD

The purpose of this protocol is to investigate the acute treatment efficacy, safety, and tolerability of atomoxetine on a once-daily dosing strategy in Taiwanese children and adolescents with ADHD.


Eligibility Criteria:
Inclusion Criteria:

* Subject must have ADHD that meet DSM-IV disease diagnostic criteria as well as severity criteria
* Subjects must be aged 6 to 16 years
* Subjects must not have taken any medication used to treat ADHD or they must have completed the washout procedures
* Subjects must be able to swallow capsules
* Subjects must be of normal intelligence in the judgment of the investigator. Normal intelligence is defined as being without evidence of significant general intellectual deficit and expected to achieve a score of 80 or more if formal IQ testing were administered.

Exclusion Criteria:

* Weigh less than 20 kg or more than 60 kg at study entry
* Have a history of Bipolar I or II disorder, psychosis, or pervasive developmental disorder
* Meet DSM-IV criteria for an anxiety disorder as assessed by the investigator
* Have a history of any seizure disorder (other than febrile seizures) or prior ECG abnormalities related to epilepsy, or subjects who have taken (or are currently taking) anticonvulsants for seizure control
* Subjects who have a history of severe allergies to more than 1 class of medications or multiple adverse drug reactions.
Impairing Drugs and Alcohol as Risk Factors for Traumatic Injuries

Impairing drugs and alcohol are major risk factors for traumatic injuries. Still there is to date little knowledge to what extent these factors affect the epidemiology of trauma. Detailed mapping of risk factors improve targeting and efficiency of primary injury prevention. The aim of this project is therefore to facilitate injury prevention through improved data collection and analysis on impairing drugs and alcohol as a contributing and modifiable factor in injury morbidity and mortality.

Study question: What is the toxicological profile among patients with suspected severe traumatic injury? Study design: a prospective population-based and national observational study will analyse toxicology from blood samples of all trauma admission during a 12 month study period.


Eligibility Criteria:
Inclusion Criteria:

* admission to any Norwegian Trauma Hospital (n=37) AND trauma team activation, during study period

Exclusion Criteria:

* age
* foreign citizens
Functional Limitations Due To The Foot Involvement In Spondyloarthritis

Seronegative spondyloarthritis (SpA) is a group of rheumatic diseases Foot involvement of the SpA is common and enthesitis, erosive changes or ankylosis are the frequent lesions. The functional status of the SpA patients are usually evaluated globally.The aim of this study is to assess specifically the foot -related functional limitations of the SpA patients.

SpA patients who had foot pain at least for 4 weeks and those having bilateral anteroposterior and lateral feet x-rays will be included into the study. Foot x-rays will be evaluated by a radiologist by using the spondyloarthropathy tarsal radiographic index (SpA-TRI). The foot related functional status of the patients will be determined by the Turkish version of the Foot and Ankle Outcome Score (FAOS).

Eligibility Criteria:
Inclusion Criteria:

* SpA patients who had foot pain at least for 4 weeks
* Those having bilateral anteroposterior and lateral feet x-rays will be included into the study

Exclusion Criteria:

* Patients who had flatfoot
* Previous foot surgery
* Any other disorder unrelated to the SpA will be excluded
Maximal Use Systemic Exposure Study of Levulan Kerastick (MUSE 2)

The purpose of this study is to evaluate the potential for systemic exposure of aminolevulinic acid (ALA) and protoporphyrin IX (PpIX) when applied topically under occlusion, in a maximal use setting in patients with multiple actinic keratoses (AK) involving the upper extremities.


Eligibility Criteria:
Inclusion Criteria:

* At least 6 Grade 1/2 AKs on one upper extremity AND
* At least 12 Grade 1/2 AKs on the OTHER upper extremity

Exclusion Criteria:

* Pregnancy
* history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins or photodermatosis
* lesions suspicious for skin cancer (skin cancer not ruled out by biopsy) or untreated skin cancers within the Treatment Area
* Body Mass Index (BMI) \> 32.0 kg/m2
* skin pathology or condition which could interfere with the evaluation of the test product or requires the use of interfering topical or systemic therapy
* significant blood loss within 60 days or donated blood/plasma within 72 hours prior to Visit 2 (Baseline)
* tested positive at screening for human immunodeficiency virus (HIV) or was known to be seropositive for HIV
* a history of lead poisoning or a history of a significant exposure to lead
* tested positive at screening for hepatitis B surface antigen, hepatitis C antibody or had a history of a positive result
* positive drug screen at Screening
* Screening safety labs are clinically significant in the opinion of the investigator
* major surgery within 30 days prior to Visit 2 (Baseline) or plans to have surgery during the study
* Subject is immunosuppressed
* currently enrolled in an investigational drug or device study
* has received an investigational drug or been treated with an investigational device within 30 days prior to Visit 2 (Baseline)
* known sensitivity to one or more of the vehicle components (ethyl alcohol, isopropyl alcohol, laureth 4, polyethylene glycol)
* use of the following topical preparations on the extremities to be treated:

  * Keratolytics including urea (greater than 5%), alpha hydroxyacids \[e.g.glycolic acid, lactic acid, etc. greater than 5%\], salicylic acid (greater than 2%) within 2 days of initiation of treatment
  * Cryotherapy within 2 weeks of initiation of treatment
  * Retinoids, including tazarotene, adapalene, tretinoin, retinol, within 4 weeks of initiation of treatment
  * Microdermabrasion, laser ablative treatments, ALA-PDT, chemical peels, 5-FU, diclofenac, imiquimod or other topical treatments for AK within 8 weeks of initiation of treatment
* use of systemic retinoid therapy within 6 months of initiation of treatment
Hospitalary Chronic Obstructive Pulmonary Disease Registry

The purpose of this study is to create an institutional registry of Chronic Obstructive Pulmonary disease through a prospective survey based on epidemiological data, risk factors, diagnosis, prognosis, treatment, monitoring and survival.

The main goal is to describe the characteristics of chronic obstructive pulmonary disease patients, including their clinical, spirometric, exacerbation and mortality characteristics within the population of the Hospital Italiano de Buenos Aires.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 40 years with a chronic obstructive pulmonary disease diagnosis according to global obstructive lung Global initiative for chronic Obstructive Lung Disease criteria.
* Follow up at the Hospital Italiano de Buenos Aires.

Exclusion Criteria:

* Refusal to participate or to agree to the informed consent.
* Known non chronic obstructive pulmonary disease respiratory disease (ej: Lung Cancer, Tuberculosis, Pulmonary Fibrosis, Neumoconiosis, Cystic Fibrosis, Sarcoidosis, etc)
* Severe alpha-1 antitripsin deficit (typr SZ or ZZ)
* Previously thoracic surgery (ej: lung volume reduction, lung transplantation).
Induction Modified TPF Followed by Concurrent Chemoradiotherapy in Locally Advanced Squamous Cell Carcinoma of the Head and Neck

The purpose of the study is to evaluate the efficacy and safety of induction mTPF chemotherapy followed by concurrent chemoradiotherapy for locally advanced squamous cell carcinoma of the head and neck cancer

The prognosis of patients with locally advanced squamous cell carcinoma of the head and neck (LASCCHN) is poor, therefore continuous research effort is being made in order to improve treatment efficacy. Standard treatment consists of concurrent chemoradiotherapy (CCRT) with cisplatin. In spite of many clinical trials and meta-analyses, the improvement of patient outcomes with the use of induction chemotherapy (IC) hasn´t been clearly demonstrated, partially due to the high toxicity of the standard TPF (docetaxel+cisplatin+fluorouracil) regimen used most frequently in this setting. Therefore, the aim of this study is to evaluate the outcomes of patients with LASCCHN treated with a less toxic induction mTPF regimen followed by CCRT.

The study will include patients with LASCCHN who - by the decision of the multidisciplinary team - have been assigned treatment with IC followed by CCRT. After being informed about the study objectives and potential risks, all patients giving written informed consent and meeting all the eligibility criteria will start the treatment. According to the study protocol, participants will receive 4 cycles of induction mTPF regimen repeated every 2 weeks followed by computed tomography (CT) response evaluation. 3-6 weeks after having completed the last cycle of mTPF, patients without disease progression will start CCRT with 2 cycles of cisplatin every 3 weeks. Twelve weeks after radiotherapy termination, a PET-CT scan will be performed in order to evaluate the treatment outcome.

Eligibility Criteria:
Inclusion Criteria:

* patients with locally advanced squamous cell carcinoma of the head and neck (LASCCHN): oral cavity, oropharynx, larynx, hypopharynx, and unknown primary
* stage cT4 and/or cN2-N3, with no distant metastases (M0).
* Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-2
* initial clinical staging evaluated in:

  1. CT scan or MRI of the neck and CT scan of the chest or
  2. FDG18 PET TC

Exclusion Criteria:

* patients with p16 positive oropharyngeal carcinoma cT0-T3 N2 M0 (stage II), unless extranodal tumor extension
* contraindications for cisplatin administration: renal insufficiency (eGFR \< 55ml/min), hearing loss, peripheral neuropathy
* dysphagia G\>2 with no percutaneous gastrostomy
* the presence of distant metastasis (M1)