cyrilzakka/clinical-trials huggingface dataset:
Study of the Prognostic Value of Musculoskeletal Ultrasound in Adults With Chikungunya

Chikungunya is a viral disease transmitted by mosquitoes whose clinical feature is the early joint damage. Approximately 8% of patients have chronic arthropathy resembling to the rheumatoid polyarthritis. The EchoCHIK study we propose is in the context of the epidemic in Martinique which began in January 2014. It should give a better understanding of arthritis and juxtaarticular of CHIK and look for signs that may allow ultrasound predict the evolution of chronic arthropathy of CHIK.


Eligibility Criteria:
Inclusion Criteria:

1. Age at onset of symptoms ≥ 45 years
2. Seen in consultation at the University Hospital of Fort-de-France
3. Suspected chikungunya infection (fever and sudden onset of joint pain affecting the wrists, hands, ankles or knees)
4. Duration of symptoms suggestive of infection chikungunya less than or equal to 10 days
5. Presence of joint pain on the day of inclusion
6. No history of inflammatory arthritis
7. Absence of steroidal or non-steroidal anti-inflammatory drugs taken within two weeks prior to inclusion
8. Ability to participate in the study throughout its duration (12 months)
9. Patient affiliated or beneficiary of a social health care.
10. Acceptance to participate in the study and monitoring proposed and signed informed consent

Exclusion Criteria:

1. Age at onset of symptoms \<45 years
2. Duration of symptoms suggestive of chikungunya for more than 10 days
3. Lack of joint pain on the day of inclusion
4. History of inflammatory arthritis Nonsteroidal anti-inflammatory drugs or
5. Taking in the two weeks preceding the inclusion
6. Inability to participate in the study throughout its duration (12 months)
7. Patient is not affiliated or beneficiary of a social health care.
8. Refusal to participate in the study or to sign a consent
Study of Varencline Effects on Cigarette Smoking Reward and Craving During a Model of Brief Quit Attempt

Study of varenicline 2.0 mg/day treatment for 2 weeks with smoking test done in laboratory on Day 8 and a 1 week quit attempt from Day 8-14.


Eligibility Criteria:
Inclusion Criteria:

* At least 10 cigarettes/day
* Interest in quitting smoking
* Willgness to comply with overnight smoking abbstiennce period followed by lab smoking test

Exclusion Criteria:

* Pregnancy
* Axis I psychiatric disorder which require treatment with psychoactive medication and would make study compliance difficult.
* Clinically significant medical condition in opinion of study clinician
* Drug or alcohol dependence inlast 12 months
* Use of other smoking cessation medications ot treatment progams in last 2 months
A Comparison of Symbicort® pMDI 2 x 160/4.5 μg Bid and Symbicort® pMDI 2 x 80/4.5 μg Bid With Formoterol Turbuhaler®, Budesonide pMDI, the Combination of Formoterol Turbuhaler® and Budesonide pMDI, and Placebo in COPD Patients

The purpose of this study is to compare a combination asthma drug (Symbicort) with its two components, budesonide and formoterol, taken individually or in combination, and with placebo in the long-term maintenance treatment of patients with chronic obstructive pulmonary disease (COPD)


Eligibility Criteria:
Inclusion Criteria:

* A clinical diagnosis of COPD with symptoms for more than 2 years
* Smoking history of 10 or more pack years
* A history of at least one COPD exacerbation requiring a course of oral steroids and/or antibiotics within 1-12 months before first visit.

Exclusion Criteria:

* A history of asthma
* Patients taking oral steroids.
* Any significant disease or disorder that may jeopardize the safety of the patient
A Study of LY900014 Compared to Insulin Lispro (Humalog) in Adults With Type 2 Diabetes

The purpose of this study is to see if LY900014 compared to insulin lispro (Humalog), both in combination with insulin glargine or insulin degludec, is safe and effective in participants with type 2 diabetes (T2D).


Eligibility Criteria:
Inclusion Criteria:

* Participants must have T2D based on the disease diagnostic criteria World Health Organization (WHO) classification.
* Participants must have been treated for at least 90 days prior to screening with either basal insulin + at least 1 prandial injection of bolus insulin or premixed analog/human insulin regimens at least twice daily.
* Participants must be treated no more than 3 oral anti-hyperglycemic medications (OAMs).
* Participants must have a HbA1c ≥7.0% and ≤11.0%.
* Participants must have body mass index (BMI) of ≤35.0 kilograms per meter squared (kg/m2).

Exclusion Criteria:

* Participants must not have been diagnosed, at any time, with type 1 diabetes (T1D) or latent autoimmune diabetes in adults.
* Participants must not have had any episode of severe hypoglycemia within the 6 months prior to screening.
* Participants must not have had 1 or more episodes of diabetic ketoacidosis or hyperglycemic hyperosmolar state within the 6 months prior to screening.
* Participants must not have used thiazolidinediones, glucagon-like peptide 1 (GLP-1) receptor agonist, or pramlintide within 90 days prior to screening.
Patient and Caregiver Attitudes and Beliefs Regarding Prescription of Intranasal Naloxone Spray for Opioid Overdose

This trial studies the attitudes and beliefs of high risk patients and caregivers regarding the prescription of intranasal naloxone spray for opioid overdose. Knowledge regarding high risk patients' and caregivers' beliefs and attitudes regarding co-prescription of naloxone spray with opioids may help to identify barriers to prescribing and helping tailor the education to better meet the needs of patients and caregivers.

PRIMARY OBJECTIVE:

I. To determine the proportion of high risk patients who perceive receiving a prescription of intranasal naloxone to be beneficial for them.

SECONDARY OBJECTIVES:

I. To determine the proportion of caregivers who perceive receiving a prescription of intranasal naloxone to be beneficial for the patient.

II. To determine the association between high risk patients' and their caregivers' characteristics (this includes cut-annoyed-guilty-eye \[CAGE\], screener and opioid assessment for patients with pain \[SOAPP\], age, gender, ethnicity, education, employment status, presence of caregiver, cancer type, cancer stage, reason for Narcan prescription, health insurance, and setting of Narcan prescription) and their perception that a prescription for intranasal naloxone is beneficial for patients.

EXPLORATORY OBJECTIVE:

I. To conduct an exploratory analysis of high risk patients' and caregivers' attitudes and beliefs regarding prescription of intranasal naloxone spray.

OUTLINE:

Participants complete a survey over 30 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have been prescribed intranasal naloxone in the past 1 year
* Patients and caregivers must be able to understand, read, write, and speak English
* Patients must have no clinical evidence of cognitive impairment, as determined by the palliative care provider (Memorial Delirium Assessment Scale score of \>= 7)
* Patients must sign an informed consent
* Caregivers may sign an informed consent if available during the visit
* Caregivers may verbally consent over the phone if not present during the visit
* Caregiver must be a friend, significant other or family member
* Caregivers must have no evidence of cognitive impairment, as determined based on orientation questions pertaining to the date, day of the week, time, and place

Exclusion Criteria:

* PATIENT: Emotional or psychosocial distress as identified by the patient's palliative care
* PATIENT: Participants with Edmonton Symptom Assessment System (ESAS) anxiety score of \> 6
Short-course Radiotherapy Combined With CAPOX and PD-1 Antibody Versus Long-course Chemoradiotherapy Combined With CAPOX for Early Low-lying Rectal Cancer

TORCH-E2 is a prospective, multicentre, randomized phase II trial. 134 low-lying early (T1-3b/N0-1M0, distance from anal verge ≤5cm) patients will be recruited and assigned to Group 1 and Group 2 (1:1). Group 1 receives SCRT (25Gy/5Fx) followed by 4 cycles of capecitabine plus oxaliplatin (CAPOX) chemotherapy and PD-1 antibody. Group 2 receives LCRT (50Gy/25Fx) followed by 2 cycles of CAPOX. A WW option can be applied to patients achieving cCR while surgery will be recommended for those who fail to achieve cCR. The primary endpoint is complete response (CR, pathological complete response \[pCR\] plus cCR) rate. The secondary endpoints include the grade 3-4 acute adverse effects (AE) rate, anal preservation rate, 3-year DFS rate, etc.


Eligibility Criteria:
Inclusion Criteria:

1. age 18-75 years old, female and male
2. pathological confirmed adenocarcinoma
3. clinical stage T1-3bN0-1, tumor maximum diameter less than 4cm
4. the distance from anal verge less than 5 cm
5. without distance metastases
6. KPS \>=70
7. with good compliance
8. microsatellite repair status is MSS/pMMR
9. without previous anti-cancer therapy or immunotherapy
10. signed the inform consent

Exclusion Criteria:

1. pregnancy or breast-feeding women
2. pathological confirmed signet ring cell carcinoma
3. clinical stage T1N0 and can be resected locally
4. history of other malignancies within 5 years
5. serious medical illness, such as severe mental disorders, cardiac disease, uncontrolled infection, etc.
6. immunodeficiency disease or long-term using of immunosuppressive agents
7. baseline blood and biochemical indicators do not meet the following criteria: neutrophils≥1.5×10\^9/L, Hb≥90g/L, PLT≥100×10\^9/L, ALT/AST ≤2.5 ULN, Cr≤ 1 ULN
8. DPD deficiency
9. allergic to any component of the therapy
Trendelenburg Position for Acute Anterior Circulation Ischemic Stroke With Large Artery Atherosclerosis Etiology (HOPES 3)

The effect of head position as a nonpharmacological therapy on acute ischemic stroke (AIS) remains inconclusive. Recent HOPES2 (Head dOwn-Position for acutE moderate ischemic Stroke with large artery atherosclerosis) suggest the safety, feasibility, and potential benefit of the head-down position (HDP) in acute ischemic stroke. The current study aims to investigate the efficacy and safety of HDP in acute moderate ischemic stroke patients with large artery atherosclerosis.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* Acute ischemic stroke confirmed by NCCT or MRI;
* Moderate neurologic deficit (6≤ NIHSS ≤ 16) within 24 hours of onset, or progressing from mild (NIHSS ≤ 5) to moderate neurologic deficit (6≤ NIHSS ≤ 16) within 24 hours, requiring ≥ 4 point increase in NIHSS score although the onset time is beyond 24 hours;
* Probable large artery atherosclerosis etiology based on the Trial of Org 10172 in Acute Stroke Treatment (TOAST) criteria (responsible artery stenosis ≥ 50% or occlusion);
* Anterior circulation stroke (internal carotid artery, M1 or M2 of middle cerebral artery);
* First stroke onset or past stroke without obvious neurological deficit (mRS≤2);
* Signed informed consent.

Exclusion Criteria:

* Pre-stroke disability (mRS≥3);
* Patients with disturbance of consciousness;
* Patients who plan to undergo or have completed thrombolysis or mechanical thrombectomy;
* Hemorrhagic stroke or combined ischemic and hemorrhagic stroke;
* Serious comorbidity, such as liver or kidney insufficiency, malignant tumor, etc;
* Other stroke etiologies, such as cardiogenic embolism, arteritis, arterial dissection, moyamoya disease, etc;
* Previous history of intracerebral hemorrhage within 1 year;
* Any contraindication to head-down position (e.g. active vomiting, pneumonia, uncontrolled heart failure);
* Planned carotid or intracranial revascularization within 3 months;
* Severe uncontrolled hypertension (systolic blood pressure over 180mmHg or diastolic blood pressure over 100 mmHg);
* Cardiac insufficiency (NYHA Class ≥II);
* Pregnant or lactating women;
* Comorbidity with other serious diseases;
* Participating in other clinical trials within 3 months;
* Patients not suitable for the study considered by researcher.
Effect of Blood Storage Age on the Resolution of Lactic Acidosis in Children With Severe Malarial Anemia at Mulago Hospital

In resolving lactic acidosis among children with severe malarial anemia, there is no difference between those transfused with blood of longer storage compared to shorter storage age

Objective of the study is to evaluate the effect of blood storage age on resolution of lactic acidosis in children with severe malarial anemia.

Methods:

Children aged 6 - 59 months admitted to ACU with Severe Malarial Anemia (Hb \<5g/dl) and Lactic Acidosis (blood lactate \>5 mmol /l), will be randomly assigned to receive either blood of shorter storage age (\<10 days) or longer storage age (21 -35 days) by gravity infusion as is the routine practice. 37 patients will be enrolled in each study arm. Physiological measurements namely blood lactate, oxygen saturation, Hemoglobin, Blood pressure, respiratory rate and pulse rate will be taken at baseline, during and after transfusion. The two groups will be compared. The primary outcome variable will be the proportion of children whose lactic acidosis resolves after 4 hrs of transfusion. 24hr mortality will be our secondary outcome.

Eligibility Criteria:
Inclusion Criteria:Children aged 6 - 59 months admitted at Acute care Unit - Mulago hospital with;

1. A positive B/S for malaria
2. Severe anemia ( Hb ≤ 5 g/dl) and
3. Lactic Acidosis (Blood lactate ≥ 5 mmol/l)
4. Written informed consent from the caretaker.

Exclusion Criteria:

1. Children undergoing transfusion with blood products other than packed cells.
2. Children with known or concurrent cardiac disease.
REFLEx Study (ENDOTAK RELIANCE G Evaluation of Handling and Electrical Performance

The REFLEx Study will evaluate if ENDOTAK RELIANCE G defibrillation leads with GORE ePTFE-covered coils are as good as or better than other comparative commercially available defibrillation leads with respect to electrical performance and termination efficacy in spontaneous tachyarrhythmic episodes.


Eligibility Criteria:
Inclusion Criteria:

* Patients who meet current ICD or CRT-D indications
* Patients who are going to be implanted with one of the aforementioned ICD or CRT-D devices
* Patients who are going to be implanted with active-fixation, dual-coil, endocardial defibrillation leads with compatible connectors (i.e., ENDOTAK RELIANCE G or study-comparative ICD leads)
* Patients who sign and date a Patient Informed Consent form prior to device implant
* Patients who remain in the clinical care of the enrolling physician in approved centers
* Patients who are at least 18 years old

Exclusion Criteria:

* Patients who have a preexisting transvenous lead system that is not completely explanted
* Patients who are hypersensitive to a single dose of approximately 1.0 mg of dexamethasone acetate
* Patients who are expected to receive a heart transplant during the duration of the study
* Patients whose estimated life expectancy is less than 12 months due to other medical conditions
* Patients who currently have or who are likely to receive a tricuspid valve prosthesis
* Patients who are likely to have an open-chest surgery in the next three months
* Patients who are currently enrolled in another investigational study that would directly impact the treatment or outcome of the REFLEx study.
* Patients who are mentally incompetent and cannot sign a Patient Informed Consent form or comply with the study
* Patients who are pregnant
A Study to Evaluate Changes in Nasal Airflow of Loratadine/Pseudoephedrine Tablet and Fluticasone Propionate Nasal Spray in Subjects Following Allergen Exposure

The purpose of the study is to evaluate changes in nasal airflow caused by loratadine 5 mg/pseudoephedrine sulfate 120 mg (Claritin D) tablet and fluticasone propionate 50 mcg per spray nasal spray (Flonase) in subjects suffering from nasal congestion and other allergy symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, ambulatory male and female subjects between 18 to 65 years of age
* Self-reported seasonal allergic rhinitis to ragweed pollen for at least 2 years prior to screening
* Documented positive skin prick test response to common ragweed (ambrosia artemisiifolia) pollen at screening or within the previous 12 months conducted at research site (prick with wheal diameter \>= 5 mm larger than the diluent response)
* In order to qualify to continue to treatment phase, at the end of priming phase (which is 3 hours), Total Symptom Score (TSS) has to be ≥ 7, with nasal congestion score alone ≥ 2 and change in peak nasal inspiratory flow (PNIF) has to be ≥ 15% from pre-prime baseline;
* Subject is willing to stop use of current decongestant and allergy medications at the start of the washout period prior to priming and during the trial
* At the discretion of the investigators, subjects may be considered with self-reported mild intermittent asthma (Using \<=2 doses of SABA (short-acting beta agonists) per week) or exercise-induced asthma
* Subject is free of any clinically significant disease that required a physician´s care and/or would interfere with trial evaluations, procedures or participation
* Subject is able to repeatedly and reliably perform PNIF measurements and must achieve PNIF value of \>=60L/min at screening
* Subject must be capable of reading English and willing to participate in all aspects of the study

Exclusion Criteria:

- Any significant medical condition which, in the judgment of the investigator, is a contraindication to the use of loratadine, pseudoephedrine and fluticasone propionate, or might interfere with the trial. These may include subjects with injury or surgery to the nose that is not fully healed, fungal infections, immunocompromised conditions (HIV, tuberculosis), severe nosebleeds, narrow-angle glaucoma, chickenpox measles..., severe facial pain or thick nasal discharge, sinusitis, constant whistling sound from the nose, structured abnormality of the nose, uncontrolled thyroid disease (e.g., hyperthyroidism, hypothyroidism), uncontrolled diabetes mellitus, coronary heart disease ischemic heart disease, uncontrolled high blood pressure, symptomatic prostatic hypertrophy, bladder neck obstruction, hepatic insufficiency, renal disease
Study of the Effectiveness of Administration of Meperidine on the Length of Active Phase of Labor in Women

This study aims to evaluate the effect of meperidine on the length of active phase of labor in nulliparous or multiparous women, who will be randomized into two (control and study) groups. Our hypothesis is that the use of meperidine during active labor has no effect on the duration of labor.

* Our aim is to examine the effect of the opioid derivative meperidine used during labor on the duration of labor in singleton pregnancies.
* The sample size was calculated using the Number Cruncher Statistical System (NCSS) / PASS 2007. Power 80% and significance level (α) 0.05, the mean (mean) ± standard deviation (SD) of the first 20 individuals included in the control group of the study (296.04 ± 170.02) and has minimal clinical significance for the active phase of labor from previous studies. We found that the sample size should be 200 (100/100) considering the duration (30 minutes).
* A Simple randomisation using a random-number table was performed by the independent nurse staff, who took no further part in the study.Using the sealed envelope technique, parturients were randomly allocated to two groups: A meperidine group and B normal saline group
* Age, height, weight, body mass index (BMI), gravida, parity, week of gestation, expected fetal weight (EFW), hemoglobin (Hb) and hematocrit (Hct) values and episiotomy requirements were recorded in two groups.Gender, birth weight, 1st and 5th minute Apgar scores and presence of meconium aspiration of the newborns in two groups were recorded.
* During labor, oxytocin induction was not performed during the latent phase in accordance with the routine protocol of our hospital. Pregnant women in both groups were given oxytocin (Synpitan® amp) at a concentration of 1% by 10 drops/min by performing amniotomy when Bishop score was 6 or cervix dilation was 4 cm and when 70% effacement was achieved. In the meperidine group, when the cervical opening was 6 cm and 70% washout, 25 mg iv bolus injection of meperidine (2.5 ml) was administered. The same amount (2.5 ml) of physiological saline was administered intravenously to the subjects in the control group. The patients were followed in NST until 10 cm clearance and 100% effacement. This time was recorded as active phase time. The time from the end of the active phase period to the birth of the baby was recorded as the duration of the second phase of birth.
* The primary outcome of interest in this study is the duration of active phase of labor .

Eligibility Criteria:
Inclusion Criteria:

* gestational age between 38 and 42 weeks
* live fetus
* cephalic presentation
* in active phase of labour

Exclusion Criteria:

* placenta previa, placental abruption
* caesarean section or any uterine scarring
* multiple gestation
* fetal macrosomia (≥4000 g)
* meperidine allergy
* use any kind of labour induction or augmentation before on admission for delivery in our hospital
Efficacy and Safety of IV Diclofenac (DIV075V)for Pain After Elective Orthopedic Surgery

This study will compare repeated intermittent IV dosing of diclofenac in patient with moderate to severe post-surgical pain from elective orthopedic surgery.

The primary objective is to evaluate the analgesic efficacy and safety of three dosage levels of parenteral diclofenac in providing pain relief as compared to placebo or Ketorolac tromethamine.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled within three weeks of the screening visit to undergo elective orthopedic surgery.
* Moderate to severe pain within 6 hours following completion of the required surgery.

Exclusion Criteria:

* Chronic pain conditions.
* Chronic disease or recent cardiovascular events.
* Known allergy or hypersensitivity to the active compounds or any of the excipients used in the study.
[11C]-PBR28 Positron Emission Tomography Study to Evaluate the Effect of ABT 555 in Subjects With Relapsing Forms of Multiple Sclerosis

This open-label positron emission tomography (PET) study is designed to determine the effect of ABT-555 on translocator protein expression level in participants with relapsing forms of multiple sclerosis.


Eligibility Criteria:
Inclusion Criteria:

Diagnosis of relapsing-remitting MS (RRMS) or relapsing secondary progressive MS (SPMS)

Neurologically stable at Screening, in the investigator's judgment and not actively experiencing or recovering from a recent relapse in the 30 days preceding the Screening Visit

A Kurtzke Expanded Disability Status Scale (EDSS) score of 1.0 to 6.0, inclusive at the Screening Visit

High or mixed affinity binder of the TSPO, as determined by rs6971 polymorphism genotyping at screening

Exclusion Criteria:

Diagnosis of primary progressive or non-relapsing secondary progressive MS

Smoking more than 10 cigarettes per day or use of a nicotine patch

Known history of, or positive screening test result for hepatitis C virus or hepatitis B virus

Varicella or herpes zoster virus infection or any severe viral infection within 6 weeks before Screening

Any type of live virus vaccine from 4 weeks before randomization

History of abnormal laboratory results