cyrilzakka/clinical-trials huggingface dataset:
Relationship Between Primary Percutaneous Coronary Intervention, Door-to-balloon Times, and Mortality for Heart Attack Patients Across England

The degree to which elevated mortality associated with weekend or night-time hospital admissions reflects poorer quality of care ('off-hours effect') is a contentious issue. We examined if off-hours admissions for primary percutaneous coronary intervention (PPCI) were associated with higher adjusted mortality and estimated the extent to which potential differences in door-to-balloon (DTB) times-a key indicator of care quality for ST elevation myocardial infarction (STEMI) patients-could explain this association. Nationwide registry-based prospective observational study using Myocardial Ischemia National Audit Project data in England. We examined how off-hours admissions and DTB times were associated with our primary outcome measure, 30-day mortality, using hierarchical logistic regression models that adjusted for STEMI patient risk factors. In-hospital mortality was assessed as a secondary outcome. Our study found that higher adjusted mortality associated with off-hours admissions for PPCI could be partly explained by differences in DTB times.


Eligibility Criteria:
Inclusion Criteria:

* STEMI patients admitted from 1 January 2007 to 31 December 2012
* STEMI patients aged over 18 years
* STEMI patients admitted directly to '24/7' PPCI-capable hospitals for PPCI
* Discharge diagnosis of STEMI
* Provision of PPCI based on initial reperfusion strategy

Exclusion Criteria:

* Hospitals performing less than 20 procedures per year
* Hospitals performing PPCIs only during regular hours
* Interhospital transfers
* PPCIs conducted within 6 hours on hospital arrival
Clinical Pharmacology Study of Oral Edaravone in Patients With Amyotrophic Lateral Sclerosis

To evaluate the pharmacokinetics of single doses of edaravone oral suspension in Patients with Amyotrophic Lateral Sclerosis


Eligibility Criteria:
Inclusion Criteria:

The key criteria are listed below.

* Patients aged between 20 and 75 years at the time of informed consent
* Japanese patients
* Among patients with ALS, those "Clinically definite ALS," "Clinically probable ALS" or "Clinically probable-laboratory-supported ALS" according to El Escorial Revised Airlie House criteria
* Patients who can consent to contraception
* Patients who have thoroughly understood the contents of the study and voluntarily provided written informed consent to participate in the study

Exclusion Criteria:

The key criteria are listed below.

* Patients in whom the possibility could not be ruled out that the current symptoms were symptoms of a disease requiring differential diagnosis, such as cervical spondylosis and multifocal motor neuropathy
* Patients undergoing treatment for malignancy
* Patients who have presence of clinically significant liver, heart, or renal disease requiring hospitalization (except ALS) and infections requiring antibiotics. Patients who have a problem in general condition and are judged ineligible by the Investigator
* Body mass index (BMI) of \<18.0 or \>30.0, or a body weight of \<50 kg
* Patients judged by the investigator (or subinvestigator) to be unsuitable for the study for any other reason
TDN, Manual Therapy and Exercise For the Management of Achilles Tendinopathy

Conflicting evidence exists regarding the recommendations from the Orthopaedic section of the American Physical Therapy Association for treatment of Achilles tendinitis. Trigger point dry needling is effective in reducing pain in several body regions, but no published (TDN) studies are found reporting the effect on Achilles tendinopathy. The purpose of this study is to investigate whether a treatment program performed including TDN, manual therapy and exercise will result in a significant improvement in pain, strength and function compared to a treatment program including manual therapy and exercise for Achilles tendinopathy. Subjects with Achilles tendinopathy that receive treatment including TDN, manual therapy and exercise will demonstrate a significant improvement in pain, strength and functional outcomes compared to the group that receives manual therapy and exercise.

This study is a randomized controlled trial, pretest-posttest control group design comparing the effect of TDN, manual therapy and exercise to manual therapy and exercise on human subjects with Achilles tendinopathy following eight treatments in four weeks and a follow up examination at three months.

Eligibility Criteria:
Inclusion Criteria:

1. pain onset greater than 4 weeks
2. primary region of pain 2-6 cm proximal to the insertion on the calcaneus
3. read and write in english

Exclusion Criteria:

1. Fear of needles or unwilling to have needling performed due to fear or personal beliefs.
2. Vascular or sensory disturbances in the lower leg which include but is not limited to injury to the nerve root or peripheral nerve in the affected lower leg, inflammatory diseases, bleeding or clotting disorders, lymphedema, peripheral vascular or peripheral arterial disease. Diabetes is included in this group due to the progressive changes to the sensation and circulation in the lower extremities.
3. Recent infection.
4. Previous surgery to the foot/ankle.
5. Steroid by injection or transdermal delivery to the posterior heel within three months.
6. Full rupture of the Achilles tendon.
7. Pregnant or may be pregnant.
8. Participants with a work related injury insured by the bureau of worker's compensation or involved in litigation related to injury of the lower leg, foot or ankle.
A Phase III Open-Label Study Of Gabapentin As Adjunctive Therapy In Japanese Pediatric Patients With Partial Seizures

Examine the efficacy, safety and pharmacokinetics of gabapentin as adjunctive therapy in Japanese pediatric patients with partial seizures


Eligibility Criteria:
Inclusion Criteria:

* Japanese male or females, ages 3-15 years old at acquisition of informed consent, 15 years old or less at the baseline visit
* Seizures are classified as simple partial, complex partial or partial becoming secondarily generalized (defined according to the International League Against Epilepsy)
* Have not been able to achieve adequate seizure control with antiepileptic drugs

Exclusion Criteria:

* Seizures related to drugs or acute medical illness
* History of any serious medical or psychiatric disorder
* Diagnosis or history of a structural CNS lesion or an encephalopathy shown to be progressive
Letrozole in Induction of Abortion of Anembryonic Pregnancy

Some studies suggest the prescription of aromatase inhibitors prior to the use of misoprostol for inducing drug abortion. the aim of the study is to compare the effectiveness of various regimens of letrozole combined with misoprostol versus using misoprostol alone in inducing complete abortion in patients with blighted ovum.

Some studies suggest prescription of aromatase inhibitors prior to the use of misoprostol for inducing drug abortion, increases the efficiency of the treatment regimen and also decreases the need for surgical interventions. Some conducted studies have mentioned reinforcing the impact of misoprostol with letrozole, but reaching the ideal dose still needs more studies, so in this study, the investigators will compare the effectiveness of various regimens of letrozole ( 10 mg/d for 3 days or a single dose of 20 mg) combined with misoprostol versus using misoprostol alone in inducing complete abortion in patients with a blighted ovum.

Eligibility Criteria:
Inclusion Criteria:

* first trimester of pregnancy
* pregnancy duration less than 12 weeks based on LMP.
* non-viable fetus (blighted ovum)

Exclusion Criteria:

* No heart disease,
* No asthma
* No History of thromboembolism
* No History of cancer
* No renal failure
* No liver diseases
* History of allergy to misoprostol or letrozole drugs.
Radiofrequency in Female Pattern Hair Loss

Pattern hair loss, also called androgenetic alopecia (AGA) is considered the most common cause of hair loss in both males and females affecting approximately 85% of males and 50% of females over 50 years of age.

RF (Radiofrequency) based devices have also been shown to be successful in promoting hair growth, thought to occur through the induction of growth factors in the papillary dermis. Studying the effect of fractional needling radiofrequency in the treatment of female pattern hair loss will pave the way for more treatment options for this common disease.

Eligibility Criteria:
Inclusion Criteria:

* Patients with female pattern hair loss

Exclusion Criteria:

* - Pregnancy and lactation.
* Bleeding tendency.
* Cases who received treatment (systemic or topical) in the last 3 months before treatment.
* Scarring alopecia.
* Other associated causes of alopecia
Fasting Comparative Bioavailability of Two Tablet Formulations of Levodopa /Benserazide in Healthy Volunteers

A group of 24 healthy volunteers receive one tablet of an association of levodopa 200 mg and benserazide 50 mg corresponding to two drug products: a test formulation (Evoser ®; Phoenix S.A.I.C. y F., Buenos Aires, Argentina) and a reference formulation (Madopar ®; Roche Pharma, Switzerland) to assess their relative bioavailability. After administration of each formulation 17 blood samples are taken and levodopa is measured by HPLC. Pharmacokinetic parameters (AUC, Tmax and Cmax) are compared.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Caucasian Argentinean males and females volunteers aged 21 to 50 years with a body mass index from 19 to 27 kg/m2 were enrolled in this study.
* All volunteers provided written informed consent prior to study initiation.

Exclusion Criteria:

* History of cardiovascular, hepatic, renal, psychiatric, neurologic, hematologic, or metabolic disease
* Drug or alcohol abuse within 2 years before the start of the study
* Smoking
* HIV, hepatitis B, or hepatitis C infection
* Consumption of any prescribed or over-the-counter drug within 2 weeks before the study or
* Participation in a similar study within the past 6 months. Female subjects were not to be pregnant, planning to become pregnant, or breastfeeding at the time of the study, and were required to use an effective method of contraception (intrauterine device or hormonal method) throughout the study.
Follow-up Study of Population Vaccinated With COVID-19 Vaccine

A multi-centered clinical follow-up study to investigate the long-term dynamic of COVID-19 antibody level after vaccination.

From December 2019, coronavirus disease 2019 (COVID-19), caused by a β-coronavirus known as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has spread across the globe. As of July 6, 2021, more than 180 million confirmed cases and around 4 million deaths have been reported globally. Till now, many treatment methods has gradually formed a consensus. At the same time, several domestic vaccines have been offered to the public for free inoculation in our country. However, due to the urgent form of the epidemic, the short vaccine development cycle and heavy tasks, there is no clear conclusion on the long-term changes in antibody levels after vaccination.Therefore, we plan to carry out a multi-center prospective observational trial to better understand the dynamic changes of the antibody levels in patients after vaccination.

Eligibility Criteria:
Inclusion Criteria:

* Adult (18 years old or elder) who prepare or have been vaccinated against COVID-19, and has not participated in similar clinical studies.

Exclusion Criteria:

* People who are allergic to any active ingredient of the vaccine, any inactive ingredient which was used in the production process, or those who have been allergic to the same kind of vaccine before.
* People who have had severe allergic reaction to vaccine before (such as acute allergic reaction, vascular neuroedema, dyspnea, etc.)
* People with uncontrolled epilepsy and other serious neurological diseases (such as transverse myelitis, Guillain-Barre syndrome, demyelinating diseases, etc.)
* People who are feverish, or suffering from acute diseases, or suffering from acute episodes of chronic diseases, or with serious chronic diseases without control.
* Pregnant woman
* Juvenile
Comparing Two Injection Sites of Local Anesthetic for Hand Surgery

The purpose of this study is to compare two different injection sites for local anesthesia in patients having hand surgery. The hypothesis is that subjects receiving injections around the three nerves of the forearm will provide faster pain control and greater patient satisfaction than patients having one injection closer to the shoulder.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years of age undergoing unilateral hand, wrist, or finger surgery
* Ability to understand and provide informed consent
* American Society of Anesthesiologists (ASA) status I-III

Exclusion Criteria:

* Patient refusal or inability to provide informed consent
* True allergy, not sensitivity, to any of the following substances: Local Anesthetics, Midazolam, Fentanyl, Hydromorphone, Propofol
* Pregnancy
* Severe hepatic impairment
* Evidence of infection at or near the proposed needle insertion site
* Any sensorimotor deficit of the ipsilateral upper extremity, whether acute or chronic, as determined by the PI and designee
* Pulmonary disease of any kind that is uncontrolled or severe in nature
* Chronic pain patients, defined as someone diagnosed with chronic pain or a chronic pain condition, under the care of a chronic pain physician, or taking oral/intravenous narcotics consistently for 30 days prior to surgery
Clinical Trial of STAHIST in Seasonal Allergic Rhinitis (SAR) Subjects

To report and compare total symptom scores, nasal symptom scores, post-nasal drip symptom scores, and adverse reactions in and between SAR subjects on active drug and SAR subjects on placebo.

This double-blind, placebo-controlled study will evaluate the efficacy and safety of STAHIST vs. placebo over a 2-week period in 100 study subjects with a history of SAR for at least two years. The study will take place in two sites, Louisville, KY and South Bend, IN. SAR symptoms to be scored and compared include: nasal congestion, rhinorrhea, nasal itching, sneezing, and post-nasal drip.

Eligibility Criteria:
Inclusion Criteria:

1. Males and females of any ethnic group between 18 and 60 years of age.
2. History of moderate to severe SAR for at least two years.
3. Subjects' symptoms resulting from the irritation of sinus, nasal and upper respiratory tract tissues will include the five symptoms that are th focus of this study: nasal congestion, rhinorrhea, nasal itching, sneezing, and post-nasal drip. Subjects must have a TSS baseline score of at least 8 on the S5 Subject Diary.
4. Prior to study drug administration, subjects' good health will be confirmed by medical history and physical examination, including pregnancy test (urine dip) before study inception.
5. Allergic hypersensitivity will be confirmed by the physician or well established patient medical history.
6. Subject's compliance with requisite run-in period for each subject will be confirmed by investigator/designee.

Exclusion Criteria:

1. Pregnancy or lactation.
2. Immunotherapy unless at a stable maintenance dose.
3. Presence of a medical condition that might interfere with treatment evaluation or require a change in therapy including but not limited to high blood pressure or urinary retention problems.
4. Alcohol dependence.
5. Use of any other investigational drug in the previous month.
6. Subjects presenting with asthma requiring corticosteroid treatment.
7. Subjects with multiple drug allergies.
8. Subjects known to have an idiosyncratic reaction to any of the ingredients in IMP (STAHIST).
9. Subject who is participating in any other clinical study.
10. Subject who is unable to meet washout requirements.
11. Subject with clinically significant abnormal vital sign or laboratory value that precludes participation.
12. Subject with any family relationship to the sponsor, investigator, or staff of sponsor or investigator.
13. A URI within 4 weeks of study inception.
14. Subjects taking beta blockers or try-cyclic antidepressants. -
Reducing Driving Offenses of Adolescent Drinkers

To determine the effectiveness of four group session of motivational counseling plus six hours of direct observations of the emergency department trauma services in comparison to four group session and six hours of community volunteering and also in comparison to four hours of education and 16 hours of community volunteering in reducing alcohol use and high risk driving behaviors and offenses among court referred 16-20 year old drivers.


Eligibility Criteria:
Age 16-20 years:

* Court referral for driving conviction and/or possession of alcohol
* Offense committed in Rhode Island
* Can speak English

Exclusion Criteria:

* Age over 20 years
* Not English speaking
* Not referred by courts
Eco-labels on Restaurant Menus

The goal of this study is to determine whether eco-labels denoting more sustainable menu items improve the healthfulness of participants' entrée and appetizer selections from a restaurant menu. US adults will complete a restaurant ordering task in which they will select menu items to order from a mock restaurant menu modeled after a popular US sit-down restaurant. Participants will be randomized to a restaurant menu with or without eco-labels denoting more sustainable menu items. The investigators will record participants' selections from the menu. Participants will also answer survey questions.

The goal of this study is to determine whether eco-labels denoting more sustainable menu items improve the healthfulness of participants' entrée and appetizer selections. The survey research company Cloud Research will recruit a sample of approximately 3,100 US adults ages 18+ who read and speak English.

Participants will complete a between-subjects online randomized experiment. They will perform a restaurant ordering task in which they will select menu items to order from a mock restaurant menu modeled after a popular US sit-down restaurant. They will be randomized to 1 of 2 conditions: 1) eco-labels or 2) control. In the eco-labels condition, participants will order from a restaurant menu with eco-labels next to more sustainable menu items. In the control condition, participants will order from a restaurant menu without eco-labels. The investigators will record participants' selections from the menu. After completing the ordering task, participants will complete an online survey.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older
* Reside in the US
* Can read and speak English

Exclusion Criteria:

* Under the age of 18 years
* Reside outside of the United States
* Unable to complete a survey in English
Peristomal Hernia Rate 5 Years After a Terminal Colostomy With the Parietex ™ TCM Parietal Prosthesis Versus Without Mesh

This study is a follow-up of the GRECCAR 07 cohort (NCT01380860). Patients will be evaluated 5 years following terminal colostomy to observe patient long-term patient outcomes from colostomy with and without mesh placement.


Eligibility Criteria:
Inclusion Criteria:

* The patient must be affiliated with a health insurance programme
* Patient was included in the GRECCAR 07 cohort (PHRC National 2011; N° RCB: 2011-A01572-39 - ClinicalTrials.gov ID: NCT01380860)
* Patient received colostomy 5 years ago

Exclusion Criteria:

* The subject is participating in another category I interventional study, or is in a period of exclusion determined by a previous study
* The subject signals opposition to participating in the study
* The patient is under safeguard of justice or state guardianship
* The patient is pregnant or breastfeeding
Multicentre LOGIC-Insulin Algorithm-guided Versus Nurse-directed Blood Glucose Control During Critical Illness (LOGIC-2)

Most critically ill patients are confronted with hyperglycaemia, which is associated with an increased mortality and morbidity risk. Normalising these elevated blood glucose levels by intensive insulin therapy may improve patient outcome, but is associated with an increased risk of hypoglycaemia. The LOGIC-2 study hypothesises that the LOGIC-Insulin computerised software algorithm will allow better (less hyperglycaemia) and safer (less hypoglycaemia) blood glucose control in critically ill patients than nurse-directed blood glucose control.


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the ICU with an expected stay of at least 48 hours and already receiving or potentially needing insulin infusion for blood glucose control. These patients should already have or need an arterial and central venous line
* Patients should be 18 years or older

Exclusion Criteria:

* Not critically ill
* Age under 18 years
* Patients already enrolled in another intervention randomized controlled trial
* Patients expected to die within 12 hours (=moribund patients)
* No arterial line or central venous line needed
* Pregnancy or lactating
* Patients suffering from ketoacidotic or hyperosmolar coma on admission
* Patients who have been previously been included in the LOGIC-2 study
* Allergy to insulin
The Three-dimensional Gait Analysis of Medial Knee Osteoarthritis

Static imaging has been commonly and clinically accepted to assess the severity of medial knee osteoarthritis (KOA), especially the radiography. Gait analysis has been adopted to evaluate the kinematic characteristics of the knees in patients with KOA. Most of the current studies focus on the sagittal plane of the knee, but very few of them focus on the frontal or horizontal plane. With the different severity of medial KOA, anatomical structures of the knees will change and influence kinematics of the knees, such as osteophytes and deformity. At present, there has been no study focusing on the relations between the imaging assessment of the severity and quantitative kinematics of medial KOA. The aim of the study is to explore the relationship between the imaging assessment based on the Kellgren-Lawrence Scores and in vivo 3D knee kinematic characteristics in Chinese patients with medial KOA during walking using a new portal gait system.

All patients are assessed according to the Kellgren-Lawrence Score.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of medial knee osteoarthritis according to the American College of Rheumatology criteria.
2. The patients are confirmed by radiographic evidence that medial tibiofemoral joint space grade was narrower than lateral tibiofemoral joint space.
3. The patients have clinical symptom of medial pain of the knee.
4. Clinical examinations are taken to examine the asymptomatic subjects to avoid knee diseases.

Exclusion Criteria:

1. Traumatic knee osteoarthritis.
2. Lateral tibiofemoral KOA or any other types of Knee OA.
3. Ambiguity of Kellgren-Lawrence scores
4. History of surgery.
5. Neuromuscular disease, cardiovascular disease or trauma that can affects gait.
6. Body mass index greater than 35.
7. Needing stick or assistance to walk or unable to walk at a speed of less than 2.0 km/h and less than 300 m.