cyrilzakka/clinical-trials huggingface dataset:
Subacromial Injection With Corticosteroid Versus Nonsteroidal Anti-inflammatory Drugs (NSAID) in Shoulder Impingement Syndrome

Injection with corticosteroid is one of the most common non-operative interventions in the treatment of subacromial impingement; however, its use is limited by its potential side effects (e.g. tendon rupture, subcutaneous atrophy, articular cartilage changes). The objective of this study was to compare the efficacy of subacromial injection of triamcinolone compared to injection of ketorolac. Thirty-two patients diagnosed with external shoulder impingement syndrome were included in this double-blinded randomized controlled clinical trial. Each patient was randomized into the Steroid group or NSAID group.

After a single injection into the subacromial space, the patients were instructed to perform home physical therapy and follow-up in four weeks. Each patient was evaluated in terms of arc of motion, Visual Analog Scale and the UCLA Shoulder Rating Scale.

The outcome measures were taken at the preinjection state, immediately post injection, and at 4 weeks follow-up.

Eligibility Criteria:
Inclusion Criteria:

1. Shoulder pain characteristic of subacromial impingement syndrome with passive and/or active abduction in the 60-120 arc of motion (positive impingement sign)
2. Diagnosis of subacromial bursitis based on tenderness to palpation anterior/lateral to the acromion. Pain may be exacerbated with the shoulder held in internal rotation (positive Hawkins test)

Exclusion Criteria:

1. Age \<18 years
2. Symptoms less than one month
3. Previous shoulder injections within the past 3 months
4. Evidence of os-acromiale or other confounding shoulder pathology on plain radiographs
5. Evidence of shoulder osteoarthritis
6. Full thickness rotator cuff tear evidenced by MRI, cuff weakness after lidocaine injection, or positive drop-arm sign
7. Systemic inflammatory condition
8. Pending litigation or work-related claims related to the shoulder
9. Previous shoulder surgery on the affected shoulder
10. Evidence of local infection
11. Evidence of adhesive capsulitis
12. Previous history of gastrointestinal ulcers or bleeding disorders
13. Evidence of shoulder instability
24-month Ticagrelor-based Dual-antiplatelet Therapy Versus Clopidogrel-based Dual-antiplatelet theRapy aftEr 12 Months of DrUg-eluting Stent Implantation in High isChEmic Risk Patients: P-REDUCE Trial

The purpose of this prospective randomized clinical trial is to compare the clinical outcomes between aspirin with ticagrelor versus aspirin with clopidogrel in high ischemic risk patients beyond 12 months after percutaneous coronary intervention with drug-eluting stent implantation


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥50 years old
2. History of drug-eluting stent implantation due to acute myocardial infarction 12 to 24 months ago
3. High-risk for ischemic events (at least one of the following) 1) Age \>65 years old 2) Medical treatments for diabetes mellitus 3) Multi-vessel coronary artery disease 4) More than 2 episodes of myocardial infarction 5) Chronic kidney disease (stage III or IV)

Exclusion Criteria:

1. Age ≥85 years old
2. Pregnant women or women with potential childbearing
3. Life expectancy \< 1 year
4. Inability to understand or read the informed consent
5. Need for long-term anticoagulation therapy
Ocular Inflammation in Cataract Patients and Response to Treatment With Xiidra

To determine if the use of Xiidra® reduces ocular surface inflammation in preoperative and postoperative cataract patients.

Single-center, prospective, randomized, investigator-initiated study

250 cataract patients, aged 60 or older, will be tested for ocular surface inflammation with the InflammaDry® immunoassay

Patients with bilateral positive MMP-9 will be randomized into a group treated with Xiidra two weeks preoperatively and six weeks postoperatively or a group not treated with Xiidra

The investigator hypothesizes that treatment with Xiidra prior to routine cataract surgery will significantly improve the quality of keratometry readings and BCVA.

Eligibility Criteria:
Inclusion Criteria:

* Positive for MMP-9 bilaterally as assessed by the Inflammadry assay

Exclusion Criteria:

* Negative Inflammadry assay in either eye
* Active diabetic retinopathy, uncontrolled glaucoma, uncontrolled uveitic inflammation
* Ocular surface diseases that might confound the interpretation of the InflammaDry assay
Efficacy and Safety of Vonoprazan as First-line Treatment for Helicobacter Pylori Eradication

This study aims to evaluate the efficacy of vonoprazan compared with esomeprazole as first-line treatment for Helicobacter Pylori(Hp) eradication, as well as the safety and economic benefits.

Vonoprazan, a novel potassium-competitive acid blocker, is proved to be superior to proton pump inhibitor in gastric acid-related diseases such as reflux esophagitis, as the increase of intragastric pH maintains for a longer period. Vonoprazan, therefore, is a promising candidate in helicobacter pylori eradication as the antibiotic resistance is rising.

This study will enroll 234 patients, and randomly assigned by computer to one of the three treatment groups.

Group A: Vonoprazan taken with bismuth, amoxicillin, furazolidone for 10 days Group B: Vonoprazan taken with bismuth, amoxicillin, furazolidone for 14 days Group C: Esomeprazole taken with bismuth, amoxicillin, furazolidone for 14 days Participants will visit the clinic for a follow-up assessment 6-8 weeks after the course of treatments.

Eligibility Criteria:
Inclusion Criteria:

1. Helicobacter pylori-positive participants determined by ¹³C-urea breath test, ¹⁴C-urea breath test, HE stain or bacterium culture
2. With no historical treatment for helicobacter pylori infection.

Exclusion Criteria:

1. Administration of antibiotics, bismuth in 4 weeks prior to inclusion or antacids including H2 receptor antagonist, proton pump inhibitor and potassium-competitive acid blocker in 2 weeks prior to inclusion
2. Active peptic ulcer with complications such as hemorrhage, perforation, obstruction, cancerization, etc.
3. With previous esophageal or gastric surgery
4. With severe systemic diseases, major organ like heart, lung, brain diseases, liver or kidney insufficiency, malignant tumor or other diseases
5. Allergy to any of the study drugs
6. Pregnancy or in lactation
7. Participated in other research within 3 months，cannot express his/her own ideas correctly or cannot cooperate with the researcher
Treatment of Papillary Thyroid Carcinoma With Radiofrequency Ablation

Investigators intend to evaluate the efficiency of Radiofrequency ablation (RFA) therapy to treat papillary thyroid carcinoma.

Investigators plan to identify patients with small papillary thyroid carcinoma and subject such patients to radiofrequency ablation (RFA) therapy.

Following RFA procedure patients will be monitored to study the changes in primary tumor volume, development of lymph node involvement, development of distant metastasis and changes in serum thyroid hormone levels.

Investigators will also assess the stability of these changes (need for repeat therapy) and the safety of the RFA procedure.

Eligibility Criteria:
Inclusion Criteria:

* Are adults
* Nodule with Papillary thyroid carcinoma meeting the below criteria:

  * Diagnosed by FNA cytology.
  * Size \< 1.5 cm
  * Non-surgical therapy is considered acceptable by the treating physician
  * Radiology evaluation deems the lesion amenable to RFA therapy with minimal risk of complication

Exclusion Criteria:

* Clinical evidence for a multifocal papillary thyroid malignancy
* Clinical evidence for local or distant metastatic disease
* Pregnancy
* Vocal cord paralysis on contralateral side
* Coagulopathy or patients on anticoagulation therapy
* Patients with prior neck surgery or neck radiation
* Patients with neck anatomy that precludes easy access by RFA
* Patients with comorbidities deemed too high of a risk for general anesthesia
* Treatment with another investigational drug or intervention (within 6 weeks of planned RFA).
* Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
Cervical Preparation in Hysteroscopy

The hysteroscopy was performed in the proliferativephase of the menstrual cycle.

The patients were given generalintravenous anesthesia (propofol/fentanyl) after the vulvar and the vaginal area had been disinfected with a 7.5% Betadinesolution by the surgical nurse All operations were performed by the same surgeon to avoid possible discrepancies between different surgeons.

Astandard rigid30 hysteroscope (Karl Storz bettocchi hysteroscope) with a 30° viewing angleand an outer sheath diameter 5.5 mm, inner sheath diameter 4.3 mm and scope diameter 2.9 mmwas used in all procedures.

A speculum was introduced into the vagina, and the uterine cervixwas visualized. Initially, the surgeon attempted to passthrough the cervical canal with the tool directly. When thatwas not possible or when the cervical canal was too rigid ortoo tight, the cervix was grasped with a tenaculum.

Eligibility Criteria:
Inclusion Criteria:

1. patients of reproductive age
2. have undergone a cesarean section at least once
3. an indication for diagnostic hysteroscopy for menstrualproblems or suspected intrauterine lesions (suchas uterine polyps and ﬁlling defects in the uterine cavity) by abnormal ﬁndings from hysterosalpingography,ultrasonography, or saline infusion sonography.

Exclusion Criteria:

1. Patients who delivered vaginally
2. Had undergone any other transcervical or transabdominal uterine and cervical intervention other than cesareansection, such as loop electrosurgical procedures, cervical cryotherapy, cervical biopsies, and spontaneousabortions, previous dilation, and previous electiveabortions.
3. Patients with cervical pathology,e.g. tears or polyps.
4. The patients with a contraindicationto prostaglandins such as hypersensitivity, bronchial asthma, glaucoma, severeasthma, cardiac, liver or kidney diseases.

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Comparison of Two Anti-HIV Regimens That Include One of Two Forms of Didanosine (ddI)

Didanosine is an effective anti-HIV drug, but it can cause stomach upset. This study tests a new form of didanosine, ddI EC, a coated pill that passes through the stomach more easily and hopefully will prevent stomach upset. The purpose of this study is to compare the effectiveness of ddI EC versus the standard form of ddI. Both forms of ddI will be given with stavudine (d4T) plus nelfinavir (NLF).

Patients are randomized to 1 of 2 open-label treatment groups. Group 1 receives ddI EC plus d4T plus NLF for 48 weeks. Group 2 receives ddI plus d4T plus NLF for 48 weeks. Both forms of ddI are administered orally once daily. Antiviral activity is determined by the magnitude and the duration of reduction of plasma HIV RNA from baseline through Week 24.

Eligibility Criteria:
Inclusion Criteria

You may be eligible for this study if you:

* Are HIV-positive.
* Are at least 18 years old.
* Have a viral load of at least 5,000 copies/ml and a CD4 count of at least 100 cells/mm3.

Exclusion Criteria

You will not be eligible for this study if you:

* Have received more than 4 weeks of treatment with nucleoside anti-HIV medications (NRTIs), or more than 1 week with protease inhibitors. (All anti-HIV treatments other than study medications must be stopped at least 14 days prior to study entry.)
* Have severe diarrhea.
* Are pregnant or breast-feeding.
* Have a history of pancreatic disease or any other serious condition.
* Have hepatitis within 30 days prior to study entry.
* Cannot take medications by mouth.
* Have received certain medications.
Neoadjuvant Treatment With Palbociclib and Exemestane Plus Trastuzumab and Pyrotinib in Estrogen Receptor (ER)-Positive, HER2-positive Breast Cancer

neoPEHP is a multicohort, open-label, exploratory, phase 2 study. Patients were eligible if they had previously untreated, histologically confirmed, unilateral, invasive, HER2-positive, ER-positive breast cancer and were suitable for neoadjuvant therapy. Patients were treated every 3 weeks with intravenous trastuzumab (8 mg/kg loading dose followed by 6 mg/kg) and oral pyrotinib (400 mg po QD) for six cycles plus oral palbociclib (125 mg once a day for 21 days in a 4-week cycle) and oral exemestane (25 mg po QD) every 4 weeks for 24 weeks. The primary endpoints was pathological complete response.


Eligibility Criteria:
Inclusion Criteria:

* We judged patients eligible for the first study cohort if they had previously untreated, histologically confirmed, unilateral, invasive, HER2-positive (3+ on immunohistochemistry or neu-amplified) and ER-positive (\>10% of cells in the tumour expressing ER) breast cancer. Other inclusion criteria were age 18 years or older, Eastern Cooperative Oncology Group (ECOG) performance status of 1 or less, and tumour classified between cT1c and cT4a-d.

Exclusion Criteria:

* metastatic disease, bilateral breast cancer, other malignant disease, inadequate bone marrow or renal function, impaired liver function, impaired cardiac function, uncontrolled hypertension, pregnancy, and refusal to use contraception.
Effect of Risedronate on Bone Morbidity in Fibrous Dysplasia of Bone

This trial is intended to test the efficacy of an oral bisphosphonate (risedronate) to decrease bone pain and improve radiological aspect in fibrous dysplasia of bone.

In open pilot studies, it has been suggested that bisphosphonates may alleviate bone pain and help decrease the surface of osteolytic lesion in patients with fibrous dysplasia of bone (FD). So, in this randomized placebo controlled trial, we test the hypothesis that the bisphosphonate risedronate reduces bone pain in patients with FD (study I, one year duration) and decrease osteolytic lesions (study II, three years duration). Patients will take risedronate during 2 months courses, every 6 months or a matching placebo. Dosage will be : 30mg tablet/day for adults and 5mg tablet x 2,4 according to the age and weight of the child. All participants will receive calcium and vitamin D. All patients with renal phosphate wasting will receive an oral phosphate supplement.

Eligibility Criteria:
Inclusion Criteria:

* Study I: patients with FD, with bone pain intensity above 3 on visual analogical scale from 0 to 10
* Study II: patients with FD with at least one osteolytic lesion and no current bone pain

Exclusion Criteria:

* patients \< 8 years old
* other diseases affecting bone metabolism
* patients with malignant diseases or other conditions likely to reduce their life expectancy to less than 3 years
* patients with history of significant upper gastrointestinal disorders
* renal failure (creatinine clearance \< 25 ml/mn)
* severe liver disease
* history of iritis or uveitis
* rickets or osteomalacia
* allergy to bisphosphonates
* pregnancy or lactation
* prior treatment with a bisphosphonate
* laboratory abnormalities that may be considered as clinically significant by trial physicians
Investigate the Effect of Food on the Pharmacokinetics of JLP-1310 in Healthy Male Volunteers

A randomized, open-label, single dose, crossover study to investigate the effect of food on the pharmacokinetics of JLP-1310 in healthy male volunteers.

A randomized, open-label, single dose, crossover clinical trial.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy male volunteer, age is over 19 years
2. Body weight is over 55kg, The result of Body Mass Index(BMI) is not less than 17.5 kg/m2 , no more than 30.5 kg/m2
3. Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial
4. Subject who has the ability and willingness to participate the whole period of trial

Exclusion Criteria:

1. Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system.
2. Subjects who are allergic to investigational drug.
3. Subjects who have a medical history which can affect the clinical trial.
4. Hypertension(Systolic BP ≥ 140mmHG or Diastolic BP ≥ 90mmHg), Liver enzyme (AST, ALT) level exceeds the maximum normal range more than one and a half times.
5. History of drug abuse or positive drug screening.
6. Participation in other drug studies within 3 months prior to the drug administration.
7. Whole blood donation within 60 days, blood component donation within 30 days or who got transfusion within 30days.
Astringency and Bitterness Perception

The investigators are conducting a study to better understand how the average consumer differentiates between bitter and astringent sensations, both of which are typically unpleasant sensations characteristic of some healthy foods. Astringency is the dry/rough sensation elicited by foods such as green bananas and some wines. Although trained scientists can differentiate between these stimuli, untrained participants rate them similarly, despite their differences. This confusion has created additional barriers in understanding the mechanism of astringent perception, which is currently debated. Understanding how to design experiments where untrained participants can clearly evaluate both sensations will lay the foundation to better understand astringency.

One mechanism that is believed to contribute to astringency is the interaction of astringent stimuli with salivary proteins. Interestingly, the salivary protein profile may be influenced by consumption of fruits and vegetables. Therefore, the investigators will evaluate how bitter and astringent perceptions differ among high and low consumers of fruits and vegetables by collecting saliva following exposure to the stimuli. This knowledge will inform approaches to increase the appeal of healthy food.


Eligibility Criteria:
Inclusion Criteria:

* BMI \> 18

Exclusion Criteria:

* issues with taste, smell, swallowing, choking, or salivation
* trying to gain or lose weight
Impact of Air Quality on Exacerbations of COPD in the Somme

All COPD patients with a diagnosis of acute exacerbation in emergency room in University Hospital of Amiens-Picardie between 01/01/2017 and 31/12/2017. The investigator will collect for each patient the home address and the work address. The duration of 1 year was chosen to take into account seasonal variations. In parallel, a daily report of the rate of ozone, particles (PM2.5 and PM10), dioxide nitrogen but also odours and pollens will be done by ATMO Picardie.


Eligibility Criteria:
Inclusion Criteria:

* All COPD patients with a diagnosis of acute exacerbation of COPD in the emergency room. The definition of COPD and acute exacerbation are the official definition of the Société de Pneumologie en Langue Française.

Exclusion Criteria:

* no exclusion criteria
Efficacy and Safety Study of WTX101 (ALXN1840) in Adult Wilson Disease Patients

The main purpose of the study was to evaluate the efficacy of ALXN1840 (formerly WTX101) for 24 weeks on non-ceruloplasmin-bound copper (NCC) concentrations adjusted for molybdenum plasma concentration in participants newly diagnosed with Wilson Disease (WD) who were aged 18 and older and who had NCC concentrations within or above the reference range at the time of enrollment in the study. The study consisted of a 24-week Treatment Period, followed by a planned 36-month Extension Period.


Eligibility Criteria:
Inclusion Criteria:

* Able to understand and willing to comply with study procedures, restrictions, and requirements, as judged by the Investigator.
* Newly established diagnosis of WD by Leipzig-Score ≥ 4 documented by testing as outlined in 2012 European Association for the Study of the Liver Wilson Disease Clinical Practice Guidelines.
* NCC levels within or above the normal reference range (0.8 to 2.3 micromole).
* Willing to undergo 48 hour washout from current WD treatment

Exclusion Criteria:

* Treatment for greater than 24 months for WD with chelation therapy (for example, penicillamine, trientine hydrochloride) or zinc therapy.
* Decompensated hepatic cirrhosis.
* Model for End-Stage Liver Disease score \> 11.
* Modified Nazer score \> 6.
* Gastrointestinal bleed within past 6 months.
* Alanine aminotransferase \> 5 x upper limit of normal.
* Marked neurological disease requiring either nasogastric feeding or intensive in-patient medical care.
* Severe anemia with a hemoglobin \< 9 grams/deciliter.
The Mobile Health Platform

This study develops and pilots the initial interface of our mobile health platform that will allow for intra-individual tailoring and personalization of health interventions. This will allow for just-in-time interventions that adapt both the content and timing, not just initially, but also over time based upon prior outcome data, responses to an intervention, current environmental and social context, activity level, location, time, and an individual's psychophysiological state.1,2

Aim 1: To develop the initial interface of the mobile health platform that will allow patients to report and receive data representing multiple health domains including blood pressure, pO2 (pulse oximeter), values, weight, physical activity, calories burned, sleep, and self-report survey measures such as pain and fatigue.

Aim 2: To assess feasibility of the mobile health platform to receive and deliver data representing multiple health domains over 1 month through a single-case study design (N=6).3 Aim 3: To develop an algorithm using the diet data collected in Aim 1 that will facilitate adaptive work by providing patients with automated real time feedback on their progress.

Aim 4: To develop an algorithm using the diet data collected in Aim 1 that will that will facilitate adaptive approaches by alerting clinicians on the progress of their patients.

At baseline we will collect demographic variables and acceptance and use of technology from surveys, and biological variables including blood pressure, weight, and blood glucose from electronic medical records. Over a period of 1 month, participants will be asked to track and collect daily data on weight using the iHealth wireless scale. Participants will also collect blood pressure (BP), pO2, and pulse using the iHealth blood pressure device. Physical activity and sleep activity will be measured using the fitbit device. Participants will receive evidence-based daily nutrition and exercise weight loss messages via text messages.

Following the one-month observation participants will be asked to complete a follow-up survey on acceptance and use of technology and to undergo a post-formative semi-structure telephone interview to discuss their perception of the usefulness and attitudes toward the platform, technical difficulties and barriers, and recommendations for future development.

Eligibility Criteria:
Inclusion Criteria:

* Patient of Picket primary care clinic
* All subjects will provide written informed consent.
* Three participants who have multiple chronic illnesses.
* Chronic illnesses of obesity (BMI\>29)
* Chronic hypertension (SBP\>140)
* Three healthy participants who do not have any chronic illnesses.
* Own a smartphone with a data and text messaging plan.
* Have Wifi available in the home.

Exclusion Criteria:

* No internet/Wifi available in the home.
* No Smartphone