cyrilzakka/clinical-trials huggingface dataset:
Clinical Trial of Cilostazol Eluting Stent System (CES-1) in De Novo Coronary Artery Lesions

The purpose of the this trial is to evaluate the clinical safety and efficacy of Cilostazol eluting stent system (CES-1) for the treatment of single de novo lesions in native coronary arteries.


Eligibility Criteria:
Inclusion Criteria:

\<Clinical selection criteria\>

1. Patients who have provided written informed consent.
2. Patients who have evidence of myocardial ischemia confirmed by subjective symptoms (chest pain etc.), ST change in the electrocardiogram or objective findings.
3. Patients who are at least 20 years old.

\<Angiographic selection criteria\>

1. Single de novo lesion in native coronary arteries
2. Target vessel diameter is 2.75 mm to 3.25 mm.
3. TIMI flow is 2 or more.
4. Angiographic percent diameter stenosis (by visual estimation) is 75% or more in AHA classification

Exclusion Criteria:

\<Clinical exclusion criteria\>

1. Acute myocardial infarction Patients whose CK-MB or troponin exceeds the facility reference upper limit and have at least one of the following is confirmed are excluded as acute myocardial infarction.

   * Ischemic symptoms and Electrocardiographic findings showing continuous ischemia (eg, ST segment elevation or depression above 1 mm in contiguous leads, or the appearance of a new left bundle branch block).
   * Pathological Q waves on electrocardiogram
   * Myocardial necrotic focus or wall motion abnormality newly confirmed in diagnostic imaging
2. Patients who cannot be given emergency coronary artery bypass grafting (CABG).
3. Patients who cannot be administered antiplatelet drugs. The following cases are conceivable.

   * Significant intracranial hemorrhage, gastrointestinal bleeding, urinary tract hemorrhage etc. within the last 6 months
   * Surgical operation is planned that requires discontinuation of DAPT after the procedure
   * Anticoagulation therapy is underway and the risk of bleeding is high
4. Bleeding tendency due to hemorrhagic diathesis or blood coagulation disorder.
5. Left ventricular ejection fraction (LVEF) is less than 30% within 30 days before the trial registration.
6. Renal dysfunction (Creatinine value exceeds 2.0 mg/dl or in case artificial dialysis).
7. Allergy to cobalt chrome alloy or contrast agent.
8. Patients who are participating in or will planning to participate in other clinical studies that may have clinical implications for the evaluation of this trial.
9. Patients who are pregnant or breast feeding.
10. Patients who are taking Cilostazol.
11. In cases where the Investigator determines that the patient's participation in the trial is inappropriate.

\<Angiographic exclusion criteria\>

1. Lesion in left main coronary trunk
2. Lesion within 5 mm from the ostium right coronary artery
3. Lesion within 5 mm from the ostium left anterior descending/the ostium left circumflex branch
4. Bifurcation lesion
5. Within 1 year after implementing PCI on the target vessel or its branch
6. There are other lesions that require PCI at the time of the procedure
7. Type C of ACC / AHA classification
Yellow Versus White Study

Blue-light-filtering IOLs are implanted increasingly often in cataract surgery. Several studies examined the effect of blue-light-filters on contrast and colour vision. However, the study outcomes were varying. The present study investigated the effect of a blue-light-filtering IOL on colour perception and contrast acuity using highly sensitive measurement methods.


Eligibility Criteria:
Inclusion Criteria:

* bilateral age-related cataract
* age 55 to 80 years
* expected postoperative visual acuity of at least 1.0

Exclusion Criteria:

* amblyopia
* corneal scars
* diabetes
* arterial hypertonia
* pseudoexfoliation-syndrome
* earlier ocular surgeries or laser treatments
* intraocular tumors
* color abnormalities
* expected postoperative visual acuity lower 1.0
Study of Safety and Immune Response of the Sm14 Vaccine in Adults of Endemic Regions

The clinical trial phase 2a is designed to assess the safety of the active ingredient (protein + adjuvant) and secondarily its immunogenicity in healthy male adults from 18 to 49 years of age with a history of infection with intestinal and urinary schistosomiasis, living in the Valley of the Senegal River, a highly endemic area for schistosomiasis. Two arms in the study will test different doses of GLA-SE adjuvant (2.5 and 5 μg). This phase IIA in adults is considered to be a preliminary step in safety before starting trials in children in endemic areas to S. mansoni or S. haematobium, target population of the vaccine.

A phase 2a trial, self-contained, open-label, randomized, dose-escalation study in two parallel arms receiving three (3) injections at D0, D28, D56; both groups receiving 50 μg Sm14 vaccine candidate solution, either combined with 2.5µg GLA-SE for the first group and 5µg for the second one in adults living in a S. mansoni and S. haematobium endemic area.

Sm14: recombinant protein produced in yeast following Good Manufacturing Practices (GMP) conditions, presented in vials containing 0.55 ml solution Sm14, 0.4 ml solution is diluted with 0.4 ml of GLA (Synthetic Glucopyranosyl lipid A) for intramuscular administration.

Medical examinations are performed at D0 (before injection, 1 hr and 4 hr after), and a safety evaluation at 24 hrs and 48 hrs, after each injection.

Blood analysis: Liver function tests - renal function tests - blood counts, at W-1 before inclusion, and then 7 days after each injections and at W13 and W21 during the follow-up.

Blood samples for immune response analysis at time of each injection, and then W12 and W20.

Eligibility Criteria:
Inclusion Criteria:

* Adults, male, 18 to 49 years old (inclusive) at the time of inclusion.
* Living in one of selected villages in Saint-Louis Region (Senegal).
* Free of obvious/severe health problems except schistosomiasis, as established by clinical examination and blood analysis, i.e. hematological exams, liver and renal function tests.
* Written informed consent to participate obtained
* Treated with 40mg/kg Praziquantel (PZQ) before inclusion (W-5 to W-4 before the first injection) in case of infection with S. mansoni and S. haematobium
* Residence in the area during the period of the study.

Exclusion Criteria:

* Adult who does not respond to one of the inclusion criteria
* Current or previous chronic administration (defined as more than 14 days) of immunosuppressive drugs or other immuno-modifying drugs.
* Known hypersensitivity to any component in the Sm14 vaccine or history of allergic disease.
* Knowledge of non-infectious chronic disease
* Acute disease at time of enrollment.
* Other conditions which in opinion of the PI may potentially represent a danger for the patient to be enrolled.
* Non residence in the study area or intent to move during the study period
Cannabis Use on Sedation for Oral Surgery Procedures

The use of Cannabis is increasing in the population, and the effects that this might have on different medical procedures are poorly understood. Particularly when submitted to deep sedation or general anesthesia, there is no consensus on best drugs or doses to deliver. The purpose of this clinical trial is to clarify the influence of chronic cannabis use during office based general anesthesia for extraction of teeth. The procedures will be performed in the Oral and Maxillofacial Surgery Clinic at the College of Dentistry.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years of age
* Class I or II according to the American Society of Anesthesiology (ASA)
* Need for dental extractions
* Extraction procedures with similar level of complexity

Exclusion Criteria:

* Surgical time lesser than 10 or greater than 30 minutes
* ASA status of III or greater
* BMI greater than 30 k/m2
* Pregnancy
* Use of anti-depressants, sedatives, or other mood-altering medications
* History of illicit substance abuse, alcoholism, or chronic opioid use
Re-evaluation of Blind Intubation Through the Air-Q Intubating Laryngeal Airway

To compare the success rate of blind technique with correction manoeuvres versus fiber optic- guided Intubation through the air Q laryngeal airway in pediatric patients

A prior G-power analysis was done to estimate the sample size. The primary outcome of this study was the first trial success rate. Using fibre exact test and assuming alpha (type I error) = 0.05 and beta (type II error) = 0.2 (power =80%), 58 patients per group would be sufficient to detect a difference 10 % in success rate among the groups. A drop out 10% of cases was expected; therefore 63 patients were required in each group to detect the difference.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists physical status I-II
* Body weight from 4 to 30 kg

Exclusion Criteria:

* Obesity
* History of gastroesophageal reflux
* History of hyperactive airway
* Patients with congenital disorders associated with difficult airway
Oncorine (H101) Combined With Tislelizumab and Chemotherapy in Previously Untreated Advanced Non-small Cell Lung Cancer

This is a single-arm, single-centre phase II study to evaluate the efficacy (PFS, ORR, DCR) and safety of recombinant human adenovirus type 5 in combination with tirelizumab and platinum-containing dual-agent chemotherapy in previously untreated patients with advanced non-small cell lung cancer who are EGFR/ALK negative. The study is divided into 2 phases.

Phase 1 is a preliminary exploration of safety and efficacy. The safety and efficacy of the regimen was assessed in the 10 patients enrolled for interim analysis. Phase 2 will continue to expand the sample size to assess the efficacy and safety of the regimen, with 20 patients planned to be enrolled.

Eligibility Criteria:
Inclusion Criteria:

1. Fully informed about the study and voluntarily signed an informed consent form (ICF); ≥18 years and ≤75 years;
2. ECOG score 0-1;
3. non-small cell lung cancer (NSCLC) confirmed by histology or pathology;
4. stage IV on imaging assessment;
5. no EGFR or ALK gene mutations (genetic testing may not be performed in patients with squamous lung cancer);
6. no previous antitumour treatment for NSCLC No prior antitumour therapy for NSCLC;
7. lesions suitable for intratumour injection of drugs;
8. measurable or assessable lesions according to RECIST 1.1 criteria.

Exclusion Criteria:

1. histological or cytological pathology of the tumour confirms a combined small cell lung cancer component;
2. those with tests suggesting severe organ dysfunction;
3. subjects with any active, known or suspected autoimmune disease are excluded;
4. expected survival is less than 3 months.
The Efficacy of Transcutaneous Pulsed Radiofrequency Acupuncture for Knee Osteoarthritis

Efficacy of transcutaneous acupoint pulsed radiofrequency with rehabilitation for knee osteoarthritis.

With the aging population, knee osteoarthritis (KOA) has become a major issue affecting functional living and causing socioeconomic burdens. Its etiology includes biomechanical abnormalities, genetics, hormones, and environmental factors. KOA causes pain, stiffness, and muscle weakness, affecting daily activities and quality of life. Previous studies have shown that traditional acupuncture or electroacupuncture can improve pain and function in knee osteoarthritis. In recent years, pulsed radiofrequency therapy has gradually been applied for pain control in KOA. However, both treatments are invasive, and patients may fear and avoid needle insertion, which also has a higher risk of complications. This study aims to combine the strengths of both treatments by using transcutaneous pulsed radiofrequency(TCPRF) at acupuncture points. This non-invasive treatment approach aims to achieve effective pain control, allowing patients to participate more actively in rehabilitation therapy.

Eligibility Criteria:
Inclusion Criteria:

* Age from 45 to 85 year-old with knee pain for more than six months
* Fulfill the combined clinical and radiographic criteria of knee OA established by the American College of Rheumatology with a Kellgren and Lawrence score of 2 or greater
* Pain score above 3 (range 0-10 on the visual analog scale; higher scores indicate greater pain
* Could participate in 4 weeks of treatment and 3 months of follow-up

Exclusion Criteria:

* Knee OA combined with any infection, inflammation, autoimmune disease, or fracture
* History or underlying disease that would affect posture and balance, such as malignancy, dizziness, vertigo, or stroke
* Ever underwent any type of knee operation or internal fixation
* Pregnant or planning to become pregnant
* Receiving other treatment for knee OA in previous 3 months
* History of epilepsy, electronic devices implanted in the body
* Active infection at the stimulator contact site
* Lack of informed consent
* Any other reason thought likely to result in inability to complete the trial
HCG (Human Chorionic Gonadotropin) Priming for Thin Endometrium in IVF (in Vitro Fertilization)

A thin endometrium is one of the most difficult problems encountered in assisted reproduction every day practice Regarding the proliferative phase, several ways of treatment have been undertaken to circumvent thin endometrium trying to increase thickness with questionable results.

The objective of the current study will be whether a daily dose of 150 IU (international units) of human chorionic gonadotropin (HCG) for seven days concomitant with estrogen administration in estrogen replacement cycles can increase the endometrial thickness and improve pregnancy outcome.

In this pilot study subjects with repeatedly resistant thin endometrium, less than 6mm, will be recruited. The investigators sought to investigate the possible role of adding low dose HCG in the follicular phase, on the endometrial growth and development. The investigators constructed this hypothesis based on the fact that LH/HCG (luteinizing hormone/human chorionic gonadotropin) receptor is present in endometrium and therefore a positive interaction could be anticipated when HCG is administered in the proliferative phase of endometrial growth. Furthermore, in a previous study, where human menopausal gonadotropin (hMG) -well known that renders its luteinizing hormone (LH) capacity due to low dose HCG contain- was compared to recombinant-follicular stimulating hormone (rec-FSH) during ovarian stimulation, endometrium was more likely to be iso-echogenic and hypo-echogenic in the hMG group, also anticipating a possible positive role of HCG activity.

Eligibility Criteria:
Inclusion Criteria:

* (1) Less than 6mm endometrial thickness before, (2) at least two failed implantations before

Exclusion Criteria:

* Abnormal uterine cavity in Hysteroscopy
the Relationship Between Cleft Lip and / or Palate (Different Types) and ABO Blood Groups.

Direct benefit of the research to assess the relationship between cleft lip and / or palate (different types) and ABO blood groups.

376 Egyptian cleft lip and/or palate patients ( age ranged from 2 days to 15 years ) With no syndrome. Blood group from records will be collected an d then assess the relationship between cleft lip and / or palate (different types) and ABO blood groups.

Eligibility Criteria:
Inclusion Criteria:

* Egyptian Patients with cleft or/and palate
* The children's age ranged between 2 days and 15 years.

Exclusion Criteria:

* syndromic patients
Research on the Construction of Cord Blood Storage Decision Aid Network Platform Based on "Internet +"

Cord blood, as an important alternative source of hematopoietic stem cells, can be used to reconstruct bone marrow hematopoietic and immune function, and is an effective means to treat children with blood diseases. However, at present, the collection rate of cord blood is not high in our country, only the mother have the right to decide whether or not. At the same time, domestic studies on cord blood collection are still very limited, for the lack of effective programs and policies, which can not provide help to improve the collection level of cord blood. Therefore, in order to improve the rate of umbilical cord blood collection, it is particularly necessary to build tools to help pregnant women decide whether to retain cord blood. This topic will investigate and analyze the cognition and retention intention of pregnant women for umbilical cord blood collection. At the same time, the related process of pregnant women for umbilical cord blood retention will be deeply explored. Based on the results of quantitative and qualitative investigation, Internet technology will be used to build a network platform for pregnant women for umbilical cord blood storage decision AIDS, and the effectiveness of this tool will be evaluated. To provide theoretical basis for clinical medical workers and umbilical cord blood bank staff to establish the decision plan of cord blood storage.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old;

  * Pregnant women whose gestational age ≥12 weeks and registered in our hospital;

    * With a certain level of education, can complete the questionnaire independently;

      * Informed consent to participate in the study

Exclusion Criteria:

* There are patients with mental illness;

  * Participated in other clinical studies in the past three months.
Maturational Changes in Cardiac Structures -- Blood Pressure Relationship -- SCOR in Hypertension

To examine a school-based population of children for maturational changes in blood pressure and cardiac structures.

BACKGROUND:

Although excessive left ventricular mass has been viewed as an adaptation to increased blood pressure, it can precede the rise in blood pressure in hypertensive models. Excessive growth of the heart may reflect additional factors contributing to eventual level of blood pressure. In children, rapid heart growth may be predictive of subsequent high childhood blood pressure level and greater incidence of cardiovascular disease in adult relatives. These studies had the potential of defining maturational changes in known risk factors which might help predict future hypertensive disease.

The study was a subproject within a Specialized Center of Research (SCOR) in Hypertension. The Request for Applications for the SCOR was released in October, 1988.

DESIGN NARRATIVE:

A total of 124 prepubertal males and females were followed longitudinally for five years. Yearly examinations defined the stages of sexual maturation. On four occasions each year, subjects were studied for resting and ambulatory blood pressure, echocardiography, anthropometry and activity assessment. Once yearly, each subject had blood drawn for hormone analyses and whole blood viscosity estimate. From these data, growth velocities of the heart and rate of change of blood pressure were determined. These parameters were analyzed to determine if rapid growth of the heart preceded or followed the rise in blood pressure observed during puberty and body size and composition, sexual maturation and hormone changes, and sympathetic activity.

The study was a subproject within a SCOR in Hypertension. Approximately 7 percent of total dollars were awarded for this subproject.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
YONDELIS (Trabectedin) Single Patient Compassionate Use / Expanded Access

The YONDELIS (trabectedin) Single Patient Compassionate Use /Expanded Access program provides patients with advanced soft tissue sarcoma, who do not qualify for ongoing clinical trials with YONDELIS (trabectedin), access to this investigational treatment.

The single patient treatment instructions for use are intended for a single patient with advanced soft tissue sarcoma. The patient will be treated with YONDELIS® (trabectedin) i.v. formulation at a dose of 1.5 mg/m2 i.v. over 24 hours on Day 1 every 21 days, provided that he/she fulfills all eligibility criteria.

The patient may continue to receive therapy until there is evidence of disease progression or unacceptable toxicity. Safety will be evaluated and serious adverse events will be reported. Disease assessments will occur according to institutional practice.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent.
2. 18 years-of-age or older.
3. Unresectable, advanced or metastatic, histologically proven soft tissue sarcoma.
4. Recovery from toxic effects of prior therapies to NCI CTC Grade 1 or better.
5. Hematologic variables:

   * Hemoglobin ≥9 g/dL
   * ANC ≥1,500/μL
   * Platelet count ≥100,000/μL
6. Serum creatinine ≤ upper limit of normal (ULN)
7. Hepatic function variables:

   * Total bilirubin ≤ ULN
   * Total alkaline phosphatase ≤ ULN, or if \> ULN, then alkaline phosphatase liver fraction or 5'-nucleotidase must be ≤ ULN.
   * AST (serum aspartate transaminase \[SGOT\]) and ALT (serum alanine transaminase \[SGPT\]) must be ≤ 2.5xULN
   * Albumin ≥2.5 g/dL

Exclusion Criteria:

1. Pregnant or breast-feeding women, or patients (male or female) not employing adequate contraception. Acceptable means of birth control include IUD, oral contraceptive, subdermal implant, and a condom with a contraceptive sponge or suppository.
2. Less than 4 weeks from last dose of systemic cytotoxic therapy, radiation therapy, or therapy with any investigational agent
3. Active viral hepatitis or chronic liver disease
4. Unstable cardiac condition, including congestive heart failure or angina pectoris, myocardial infarction within 1 year before enrollment, uncontrolled arterial hypertension or arrhythmias
5. Active infection
Post Photorefractive Keratectomy (PRK) Use of an Eye Shield for Maintaining Vision and Mitigating Pain

The purpose of this research is to determine if an investigational thin shield over the cornea can safely and effectively reduce or eliminate pain following Post Photorefractive Keratectomy (PRK).

The thin shield is made of silicone. The materials used to make the corneal shield all have a history of use in medical devices, contact lenses, and/or corneal shields and have been used safely in the eye.

See above

Eligibility Criteria:
Inclusion criteria.

* Subjects age 18 and older with healthy eyes.
* Nearsightedness between -0.50 diopters and -11.00 diopters with or without astigmatism of up to 3.50 diopters.

Exclusion criteria.

* Subjects under the age of 18.
* Patients with excessively thin corneas.
* Patients with topographic evidence of keratoconus.
* Patients with ectactic eye disorders.
* Patients with autoimmune diseases.
* Patients who are pregnant or nursing.
* Any other anterior segment abnormality other than that associated with PRK
* Any abnormalities associated with the eye lids
* Uncontrolled blepharitis or dry eye
* Prior laser treatment of the retina
* Any ophthalmic surgery performed within three (3) months prior to study excluding PRK or LASIK
* Diagnosis of glaucoma
* Active diabetic retinopathy
* Clinically significant inflammation or infection within six (6) months prior to study
* Uncontrolled systemic disease (e.g., diabetes, hypertension, etc.) in the opinion of the Investigator
* Participation in any study involving an investigational drug within the past 30 calendar days, or ongoing participation in a study with an investigational material
* Intolerance or hypersensitivity to topical anesthetics, antibiotics, steroids or any other pharmaceuticals that may be used pre and post surgically Specifically known intolerance or hypersensitivity to contact lenses or any component of the investigative material
* A medical condition, serious concurrent illness, or extenuating circumstance that would significantly decrease study compliance, including all prescribed follow-up
* Any condition that, in the opinion of the investigator, would jeopardize the safety of the patient