cyrilzakka/clinical-trials huggingface dataset:
Detection of Chlamydia (CT) and Gonorrhea (NG)

To evaluate the illumigene Chlamydia and illumigene Gonorrhea assays, using the illumipro-10, with male urine, female urine, physician-collected (medical professional) endocervical swabs and self-collected vaginal swabs taken from symptomatic and asymptomatic patient populations.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female
2. Any ethnicity or race
3. Subject \>14 and \<89 years of age
4. Subject who voluntarily gives written informed consent; not applicable for leftover specimens
5. Symptomatic or asymptomatic subject who is able and willing to provide the required urine and swab samples for testing for CT and NG
6. Leftover urine specimens

Exclusion Criteria:

1. Subjects \< 14 or \>90 years of age
2. Subjects who are unwilling to sign the written informed consent; not applicable for leftover specimens
3. Subject who is unwilling or unable to provide the required urine and swab samples for testing; not applicable for leftover specimens
4. Individuals who have been on antibiotic medications within 10 days.
5. Multiple sets of specimens from the same subject at different office visits
6. Samples collected or processed in manner other than specified in the study protocol and Investigational Use Only package insert.
7. Frozen archived specimens
Long-term Neurovascular Complications After Radiation Therapy in Head and Neck Cancer

Head and neck cancer is a group of cancers develop from the soft tissues, salivary gland, mucosa of the upper respiratory or digestive system covering the oral and nasal cavity. Radiotherapy is usually the standard treatment of Head and neck cancers. In the present study, investigators aim to study the prevalence of cervical-cranial vascular complications during the early stages in these Head and neck cancer patients receiving Radiotherapy. Investigators will also compare the results between Nasopharyngeal cancer and other Head and neck cancerpatients receiving Radiotherapy.


Eligibility Criteria:
Population: Prospective cohort

Inclusion Criteria:

1. Age ≥20 years.
2. Head and neck cancer patient .
3. Had ever received radiation therapy (RT) ≦ 72 months before inclusion in the registry.
4. Had ≥ 1 brain images and cervical-cranial vascular studies between the end of RT and d date of enrolment.

Exclusion Criteria:

1. Age \<20 years.
2. Patients not willing to sign the informed consent.

Population: Retrospective validation cohort

Inclusion Criteria:

1. Age ≥20 years.
2. Head and neck cancer patient.
3. Had ever received radiation therapy (RT) \> 120 months before the adoption date of IRB at the participant site.
4. Had ≥ 2 brain images and cervical-cranial vascular studies between the end of RT and 6\~10 years after RT, one within 5 years after RT, the other after 5 years after RT.

Exclusion Criteria:

1.Age \<20 years.
Efficacy and Safety of Pramipexole Compared to Placebo in the Treatment of Restless Legs Syndrome (RLS)

A 12 week clinical trial was conducted in the United States in order to compare pramipexole (Mirapex®) versus placebo for the ability to reduce the symptoms of restless legs syndrome in adult subjects.


Eligibility Criteria:
Platysma Incision Cosmesis

The anterior cervical fusion and decompression (ACDF) surgery provides direct access to symptomatic areas of the cervical spine. Cosmesis, including factors like wound healing, is an important issue for patients who undergo surgery on anterior neck structures. One significant factor that impacts cosmetic healing in patients who undergo the ACDF surgery is whether a vertical or transverse incision of the platysma muscle in the neck was used to access the cervical spine.

The purpose of the present study is to compare cosmetic outcomes in vertical versus transverse platysmal incisions for anterior cervical spine exposures. Researchers intend to analyze this effect with a prospective comparative study model. A targeted number of 100 patients who undergo anterior cervical surgery, as part of their standard of care, will be randomized to receive either a transverse or vertical platysmal incision during the exposure part of their procedure. Informed consent for inclusion in the study, as approved by the Institutional Review Board, will be obtained from all patients in addition to consent for the surgical procedure. Regardless of the platysmal incision, all patients will receive a standard transverse skin incision, as is done routinely in anterior cervical exposures. After the surgery, all closures will be done in a standard manner.

These patients will be followed up in the clinic at two weeks, three months, six months, and one year. They will be evaluated for wound healing and incision cosmesis using a modification of The Hollander Wound Evaluation Scale. Clinical photographs of the patients' necks will be captured during these visits in a manner that does not reveal any patient identifiers in any way. The incisions and overall cosmesis will be graded using the scale mentioned above. The data will be analyzed to determine if a transverse platysmal incision offers better cosmetic results than a vertical platysmal incision, or vice versa, and will also be used to validate the modified wound evaluation scale.


Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing elective Anterior Cervical Decompression and Fusion surgery for degenerative spinal pathologies by Dr. Tony Tannoury or Dr. Chadi Tannoury at Boston Medical Center as part of their standard of care.

Exclusion Criteria:

* Patients undergoing revision anterior cervical spine surgeries with a pre-existing scar. Patients with cervical spine tumors/neoplastic pathologies. Patients undergoing surgery for cervical spine trauma.
The ED95 of Single Intravenous Bolus Remimazolam Besylate in Pediatric Patients During General Anesthesia Induction

Due to the incomplete development of systems and low pain thresholds in the pediatric population, good general anesthesia is required during the perioperative period to ensure the smooth progress of the surgery.Propofol is often used for anesthesia induction in clinical work, which can achieve good anesthesia effects. However, this drug has obvious injection pain and is prone to significant inhibition of blood circulation, and may even lead to adverse conditions such as respiratory depression in children. For the pediatric population, maintaining appropriate anesthesia depth and stable circulation during the induction period of general anesthesia has always been a focus of attention and research by anesthesiologists.Remimazolam besylate is a new type of water-soluble ultra short acting benzodiazepine drug that is hydrolyzed and metabolized by plasma esterase in the body, independent of liver and kidney function, and the metabolite zolam propionic acid has no pharmacological activity; Rapid onset and failure, short sedation recovery time; Has little impact on respiration and circulation; And there is no injection pain.Remazolam besylate is highly suitable for children due to its characteristics, and some studies have demonstrated the safety of intravenous injection of Remazolam besylate. However, there is limited research on its dosage exploration, which to some extent limits its clinical application in children.This study aims to explore the 95% effective dose (ED95) of single intravenous injection of remidazolam besylate in children of different age groups, providing a theoretical basis for the use of remidazolam besylate in pediatric anesthesia.

This experiment was divided into three groups based on the age of the children, namely 1-3 years old, 4-6 years old, 7-12 years old, with an initial dose of 0.2mg/kg. The time of consciousness loss in the children was evaluated after injection of ramazolam besylate to determine whether sedation had been achieved. The next dose was adjusted to 0.05mg/kg according to biased coin design,to further explore the ED95 of a single intravenous injection of ramazolam in children of different age groups.

Eligibility Criteria:
Inclusion Criteria:

1. with American Society of Anesthesiologists (ASA) physical status I or II；
2. aged 1-12 years；
3. children with weight for age within the normal range；
4. were scheduled general anesthesia surgery

Exclusion Criteria:

1. Children who had gastrointestinal,Cardiovascular or endocrine dysfunction;
2. contraindication to preoperative sedation or had a known allergy or hypersensitive reaction to remimazolam;
3. recently respiratory infection, mental disorder;
4. other reasons that researchers hold it is not appropriate to participate in this trial.
A Study of Non-Small Cell Lung Cancer (NSCLC) Patients Receiving Second-Line Nivolumab Monotherapy in Asia

The purpose of this study is to investigate the safety of patients in Asia with Non-Small Cell Lung Cancer (NSCLC)who are treated with Nivolumab monotherapy as a second line or third line treatment.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Advanced metastatic stage IIIB/IV NSCLC (Nonsquamous and squamous)
* 1 to 2 prior systemic therapies
* Eastern Cooperative Oncology Group (ECOG) Performance Status of less than or equal to 1
* Participants must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI)
* Prior radiotherapy or radiosurgery must have been completed at least 2 weeks prior to starting study treatment

Exclusion Criteria:

* Women with a positive pregnancy test at enrollment or prior to administration of study medication
* Participants with active central nervous system metastases
* Participants with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first dose of study drug
* Participants with previous malignancies are excluded unless a complete remission was achieved at least 2 years prior to study entry AND no additional therapy is required or anticipated to be required during the study period
* Participants with carcinomatous meningitis

Other protocol defined inclusion/exclusion criteria could apply
A Multinational Study to Evaluate the Effects of a 28-Day Oral Contraceptive on Hemostatic Parameters in Healthy Women

This study is being conducted to evaluate the impact of DR-102, a 28-day oral contraceptive compared to a standard 28-day oral contraceptive regimen on hemostatic parameters in healthy women.


Eligibility Criteria:
Inclusion Criteria:

* Premenopausal, non-pregnant, non-lactating women age 18-40 years old
* Body Mass Index (BMI) ≥18 kg/m² and \<30 kg/m²
* Regular spontaneous menstrual cycle
* Others as dictated by FDA-approved protocol

Exclusion Criteria:

* Any condition which contraindicates the use of combination oral contraceptives
* Any history of, or active, deep vein thrombosis, pulmonary embolism, or arterial thromboembolic disease within one year of screening
* Thrombophlebitis or thromboembolic disorders; known or suspected clotting disorders; thrombogenetic valvulopathies or rhythm disorders
* Others as dictated by FDA-approved protocol
Effect of Antioxidant Docosahexaenoic Acid (DHA) in Cystic Fibrosis Patients

This study evaluates the effect of antioxidant docosahexaenoic acid (DHA) in patients with cystic fibrosis. Half of participants will receive DHA, while the other half will receive placebo.

Several studies show that patients with cystic fibrosis (CF) usually have, compared to the normal population, low levels of linoleic acid (LA) and docosahexaenoic acid (DHA) and increase in arachidonic acid (AA), which is pro-inflammatory. Normalization or modification of this fatty acid pattern (AP) could reduce chronic inflammation. The aim of this study is to assess the effect of oral supplementation with DHA for one year in pediatric patients (6-18 years) with CF, on inflammatory parameters, AP profile, lung function (spirometry) and number of exacerbations.

Eligibility Criteria:
Inclusion Criteria:

* Patients of both genders with a diagnosis of cystic fibrosis.
* FEV1 \> 40%.
* Age between 6 and 18 years.
* Patients who grant their informed consent or whose representative grants informed consent to participate in the study.

Exclusion Criteria:

* Pregnant or breastfeeding women
* Basal oxygen saturation \<92% or household supplemental oxygen needs.
* Massive hemoptysis
* Patients who are not able to follow or who cannot be assessed in the study according to the protocol.
* Any circumstance that, at the discretion of the doctor, may involve a clinical risk or harm, the patient's participation in the study or that interferes with the evaluation of the same.
* Use of systemic glucocorticoids or in the 4 weeks prior to inclusion in the study.
* Use of non-steroidal anti-inflammatory drugs in the 2 weeks prior to inclusion in the study.
* Use of investigational drugs or participation in another clinical trial within 30 days prior to inclusion in the study or within the 5 elimination half-lives of the investigational drug.
* Be already supplementing with Omega -3, fish oil or DHA
Lactoferrin Versus Ferrous Fumarate for Treatment of Mild to Moderate Iron Deficiency Anemia During Pregnancy

This study will conducted to evaluate and comparison between the effectiveness, safety and acceptability of lactoferrin alone, ferrous fumarate alone and combination of both for the treatment of mild to moderate IDA during pregnancy.

Anemia in pregnancy is a major public health problem, where it has been estimated that 41.8% of pregnant women worldwide are anemic .

Iron deficiency anemia (IDA) is the condition in which there is anemia due to a lack of iron. IDA develops when available iron is insufficient to support normal red cell production and is the most common type of anemia Anemia has a significant impact on the health of the fetus as well as that of the mother. It impairs the oxygen delivery through the placenta to the fetus and interferes with the normal intrauterine growth, leading to fetal loss and perinatal deaths. Anemia is associated with increased preterm labor (28.2%), preeclampsia (31.2%), and maternal sepsis.

The daily requirement of iron is around 1.5 mg in nonpregnant women. This requirement increases dramatically during pregnancy to reach 6-7 mg/day (total 1000 mg) with advanced gestational age. Pregnancy causes a twofold to threefold increase in the requirement for iron and a 10- to 20-fold increase in folate requirement. The increase in demand for iron is mainly due to fetal requirement, placenta, blood volume, tissue accretion, and the intra-partum potential for blood loss

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women from 24-36 weeks of gestation.
* Mild to moderate anemia.

Exclusion Criteria:

* Women with a history of anemia due to any other causes other than IDA.
* Severe anemia requiring blood transfusion.
* History of peptic ulcer.
* known hypersensitivity to iron preparations.
DNA Biomarkers in Tissue Samples From Patients With Osteosarcoma

This research study is studying DNA biomarkers in tissue samples from patients with osteosarcoma. Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about changes the occur in DNA and identify biomarkers related to cancer. DNA analysis of tumor tissue may also help doctors predict how well patients will respond to treatment.

OBJECTIVES:

I. To comprehensively detect genomic, epigenomic, and transcriptomic aberrations in tissue samples from patients with osteosarcoma that may play a role in chemoresistance and metastasis using high-resolution genome-wide technologies.

II. To identify recurrent genetic mutations involved in the pathogenesis of osteosarcoma, especially for the development of chemoresistance and metastatic tumors.

III. To identify and validate these biomarkers for new therapeutic targets for patients with osteosarcoma, especially those with metastatic disease and whose tumors are resistant to standard chemotherapy.

OUTLINE: This is a multicenter study. Archived tumor tissue and peripheral blood DNA specimens are analyzed for DNA copy number profiling, gene expression profiling, DNA methylation profiling, microRNA profiling, and genomic resequencing. Clinical data including demographics; date of diagnosis, surgery, chemotherapy, recurrence, progression, and death; imaging; toxicity; and pathologic data elements associated with the specimens are also collected and analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of osteosarcoma
* Fresh-frozen samples collected at the time of diagnosis with matchedblood DNA (preferred) from patients enrolled on the following osteosarcoma biology protocols:

  * COG-P9851
  * COG-AOST06B1
* Available clinical outcome data
* Not specified
* Not specified
Mechanisms and Therapeutic Effects of the Relaxation Response in Elderly Hypertensive Patients

The purpose of this study is to determine whether the relaxation response is more effective than attention control in reducing blood pressure and medication dosage in elderly adults with isolated systolic hypertension.

The purpose of this study is to determine whether the relaxation response is more effective than health education training (attention control) in reducing systolic blood pressure and anti-hypertensive medication elimination in elderly adults with isolated systolic hypertension.

Eligibility Criteria:
Inclusion Criteria:

* 55 years or older
* currently taking at least 2 anti-hypertensive medications
* systolic blood pressure between 140-159 mmHg
* diastolic blood pressure less than 90 mmHg
* read and understand English
* access to a telephone
* ability to attend all study visits

Exclusion Criteria:

* other cardiovascular disease
* major medical illness
* previous experience with any RR eliciting technique
* current use of:beta-agonist bronchodilators, systemic corticosteroids, anti-convulsants/psychotics, immunosuppressants, cytotoxic therapy, anabolic steroids, antidepressants (other than SSRIs), dicyclomine, bile acid binding resins, or sympathomimetic medication
Methanesulfonic Acid Cinepazide Injection for Treatment of Acute Cerebral Infarction

Using placebo as control, The purpose of this study is to evaluate the efficacy and safety of methanesulfonic acid cinepazide injection to relieve disabled degree of acute cerebral infarction patients, and explore the best safe and effective dose as well as dose method.

The study will enroll 288 acute cerebral infarction patients. Patients will be assigned randomly to receive either Methanesulfonic acid cinepazide injection or placebo treatment. All patient in the study will receive standard of care treatment and clinical, diagnostic, laboratory, safety, and follow-up evaluations. Follow-up evaluations, including National Institute of Health stroke scale(NIHSS), Barthel index score and modified Rankin scale assessments, will be done periodically until 90 days after onset. The degree of disabled improved will be a primary measure of drug effectiveness.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 40 and 75 years old，male/ female；
2. The clinical diagnosis of first onset patients with anterior circulation infarction or who have suffered from stroke in history and complete recover from neurologic impairment (mRS score \<2 before this disease）
3. Patients is proved by head skull CT and cerebral hemorrhage was excluded；
4. course of disease≤72h，the NIHSS score is ≥7 and ≤22；
5. Patients who voluntarily sign written informed consent. -

Exclusion Criteria:

1. Patients who suffer from cerebral infarction accompanied by disorder of consciousness, posterior circulation infarction, lacunar infarction and transient ischemic attack.
2. Patients who suffer from brain arteritis, brain tumor, brain injury, intracranial infection, brain parasitic disease, and so on . Patients who suffer from cardiac diseases such as rheumatic heart disease, coronary heart disease with atrial fibrillation .
3. Patients who suffer from severe complications, and expected survival period is within three months.
4. Patients require thrombolysis, anticoagulation, anti- fibrosis treatment .
5. Patients who suffer from serious brain artery stenosis that should go through interventional therapy .
6. Patients whose white blood cells or neutrophils is below the lower limit of the normal reference value .
7. Patients who have bleeding tendency or suffered from serious bleeding in 3 months.
8. Patients who have severe cardiac, liver and kidney disease, or whose kidney and liver function tests was abnormal（ALT,AST≥1.5 times of upper normal limit，Cr\>upper normal limit）.
9. Patients who have complications of malignant tumor, serious or progressive disease in blood, digestion or other system.
10. Patients who have complications of mental illness un can not or do not want willing to cooperate .
11. Doubt or does have alcohol, drug abuse history
12. Allergic constitution or allergic to the test drug ingredients .
13. Pregnancy and lactation women or those who has a recent fertility plan
14. Patients who have participated in other clinical experiments three months before this test.
15. The patients who is unsuitable to participate in the clinical test in the view of researchers
Effectiveness of Bilateral PTNS Compared to Unilateral PTNS for the Treatment of Overactive Bladder/Urge Incontinence

This study is designed to evaluate whether bilateral Posterior Tibial Nerve Stimulation is more effective than unilateral Posterior Tibial Nerve Stimulation at treating overactive bladder and urge urinary incontinence

Percutaneous tibial nerve stimulation (PTNS) is an accepted treatment for overactive bladder that can be accomplished in the office with minimal side effects. It is currently carried out by stimulating one of the posterior tibial nerves unilaterally. The aim of this study is to determine whether bilateral percutaneous tibial nerve stimulation is more effective than unilateral stimulation. Patients with a diagnosis of overactive bladder who have previously failed lifestyle changes and/or pharmacologic therapy will be offered percutaneous tibial nerve stimulation. Enrolled patients will be randomized into two groups. The control group will receive the traditional unilateral treatment of PTNS. The intervention group will receive bilateral PTNS treatment. Intervention success will be measured by improvement in overactive bladder symptoms assessed by improvement in the scores on the overactive bladder questionnaire symptoms bother and decrease in number of voids, nocturia episodes and incontinence episodes as reported in the voiding diary

Eligibility Criteria:
Inclusion Criteria:

1. Female patients over the age of 18 who have previously tried and failed, or were unable to tolerate, behavioral therapy
2. Patients who consent to participate in the study
3. Patients on pharmacologic therapy at the time of recruitment can continue their treatment

Exclusion Criteria:

1. Pregnant patients
2. Patients with pacemakers of implantable defibrillators
3. Patients with neurogenic bladder
4. Patients who have received Botox or have an implant for sacral nerve stimulation
5. Patients with uncontrolled bleeding disorder
6. Patients with unhealed ulcers or with leg edema surrounding medial malleolus